Healthcare units in the heart area - Ministerio de Sanidad, Servicios

Transcription

Healthcare units in
the heart area
Standards and
recommendations on quality
and safety
REPORTS, STUDIES AND RESEARCH 2011
MINISTRY OF HEALTH, SOCIAL POLICY AND EQUALITY
Healthcare units in
the heart area
Standards and
and safety
REPORTS, STUDIES AND RESEARCH 2011
MINISTRY OF HEALTH, SOCIAL POLICY AND EQUALITY
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Imprime: Solana e Hijos, A.G., S.A.U.
http://publicacionesoficiales.boe.es
Healthcare units in
the heart area
Standards and
and safety
Institutional, technical and scientific coordination
• Inés Palanca Sánchez. Health Planning and Quality Office. QA-NHS. MSPSI Technical
and Institutional Directorate.
• Alfonso Castro Beiras. Scientific Co-manager. Head of the Cardiology Service of the Uni
versity Hospital Complex A Coruña. Co-ordinator of the National Healthcare System
Ischemic Cardio-pathology Strategy.
• Carlos Macaya Miguel. Scientific Co-manager. Head of the Cardiology Service, San Car
los Clinical Hospital. President of the Spanish Society of Cardiology (Sociedad Española
de Cardiología).
• Javier Elola Somoza. Technical Manager. Elola Consultores S.L.
Editorial board
• José Luis Bernal Sobrino. EC Consultoría y Gestión en Sanidad S.L.
• Alfonso Castro Beiras. Head of the Heart Institute at the Juan Canalejo University Hospi
tal (La Coruña). Head of the NHS Ischemic Cardio-pathology Strategy.
• Javier Elola Somoza. Elola Consultores S.L.
• Carlos Macaya Miguel. Head of the Cardiology Service, San Carlos Clinical Hospital. Pre
sident of the Spanish Society of Cardiology (Sociedad Española de Cardiología).
• Inés Palanca Sánchez. Health Planning and Quality Office. AC-SNS. MSPSI.
• José León Paniagua. Doctor of Architecture.
Group of Experts
• María del Carmen Álvarez González. Health Planning and Quality Office. QA-NHS.
MSPSI.
• Virgina Argibay Pytlik. Head of the Spanish Society of Nursing in Cardiology (Asociación
Española de Enfermería en Cardiología).
• José Brugada Terradellas. Person responsible for the Cardiac Arrhythmia Unit Hospital
Clinic (Barcelona).
• Alfonso Castro Beiras. Head of the Heart Institute at the Juan Canalejo University Hospi
tal (La Coruña). Head of the NHS Ischemic Cardio-pathology Strategy.
• José María Cortina Romero. Head of the Cardiovascular Surgery Service. 12 Octubre
Hospital (Madrid).
• Carlos Fernández Palomeque. Head of the Cardiology Section at the Son DuretaUniver
sity Hospital (Palma de Mallorca).
• Miguel Ángel García Fernández. Full Professor for Cardiology. Complutense University.
Madrid.
• Javier Goicolea Ruigómez. Head of the Hemodynamics Service. Puerta de Hierro-Maja
dahonda University Hospital (Madrid). President of the Hemodynamics and Interventio
nist Cardiology Section of the Spanish Society of Cardiology.
• Miguel Josa Barcía-Tornel. Cardiovascular Surgery at the Clinical Hospital of Barcelona.
Depty President of the Spanish Society for Thoracic and Cardiovascular Surgery (Socie
dad Española de Cirugía Torácica y Cardiovascular).
• Francisco de Asís Jove Domínguez-Gil. General Deputy Manager of Healthcare. Spanish
National Institute for Health Care Management (Instituto Nacional de Gestión Sanitaria).
MSPSI.
• Eva Laraudogoitia Zaldumbide. Jefa de Sección. Head of Section. Galdakao Hospital
(Guipuzcoa). Treasurer of the Spanish Society of Cardiology.
HEALTHCARE UNITS IN THE HEART AREA
7
• Carlos Macaya Miguel. Head of the Cardiology Service, San Carlos Clinical Hospital. Pre
sident of the Spanish Society of Cardiology (Sociedad Española de Cardiología).
• Fernando Mejía Estebaranz. Medical Manager at the 12 Octubre Hospital (Madrid).
• Cesar Moris de la Tassa. Head of the Cardiology Service. Medical Manager at the Cen
tral University Hospital of Asturias.
• Julián Pérez-Villacastin. Head of the Arrhythmia Section, San Carlos Clinical Hospital.
Secretary General of the Spanish Society of Cardiology.
• Sara Pupato Ferrari. Manager of the Spanish National Institute for Health Care Manage
ment. MSPSI.
• Luis Rodríguez Padial. Head of Service at the Virgen de la Salud Hospital. Toledo.
• José Alberto San Román. Manager of the Institute of Heart Sciences (ICICOR), Clinical
Hospital of Valladolid.
• Gines Sanz Romero. Manager of the Cardiovascular Translational Research Department.
Carlos III Spanish National Centre for Cardiovascular Research (Centro Nacional de
Investigaciones Cardiovasculares Carlos III). Carlos III Institute. Madrid.
• José Manuel Vázquez Rodríguez. Clinical Management and Organisation Manager. Area
of the Heart. A Coruña University Hospital Complex.
• Joseba Zuazo Meabe. Head of the Cardiovascular Surgery Service at the Basurto Hos
pital (Bilbao). President of the Spanish Society for Thoracic and Cardiovascular Surgery.
Publishing support
• Alberto Segura. Health Planning and Quality Office. QA-NHS. MSPSI.
8
REPORTS, STUDIES AND RESEARCH
Índice
Executive summary
15
1.
Introduction
23
1.1. Document scope
23
1.2. Document goal
28
1.3. Working methodology
28
2.
3.
Situation analysis
31
2.1. Standards and recommendations
31
Patient rights and guarantees
43
3.1. Information to patients. Informed consent
43
3.2. Guarantee of the rights of the patient
46
3.3. The right to information about healthcare alternatives and
its results
4.
5.
49
Patient safety
53
4.1. Safety culture
56
4.2. Communication during patient transfer
58
4.3. Safety in the use of medication
59
4.4. Safety in the use of health products
59
4.5. Prevention of bedsores
60
4.6. Infection prevention
61
4.7. Epidemiological alert
61
4.8. Patient identification
61
4.9. Management of hemoderivatives
62
4.10. Patient safety and health risk management
63
4.11. Volume of activity and safety threshold
64
4.12. Patient implication in his safety
66
4.13. Self-protection program
66
Area of the heart: assistance network, healthcare processes
and regionalization of services
67
5.1. Assistance network
68
5.2. Block of healthcare processes in the cardiology area
71
9
6.
7.
8.
5.3. Regionalization
76
5.4. Links between blocks of healthcare processes and CCUs
80
5.5. Managerial structure of the CCUs network.
86
5.6. Organization and operating manual
88
5.7. Information and communication technologies (ICT)
88
5.8. Information system and patient management
90
Clinical resources and non-invasive techniques 93
6.1. Multipurpose clinical resources
93
Diagnosis through imaging
111
7.1. Organization and functioning
113
7.2. The echocardiographic office
114
7.3. Cardionuclear medicine room and equipment
117
7.4. MR and CT equipment
119
7.5. The digital cardiac image laboratory
120
7.6. Human resources
121
Hemodynamics and intervention
125
8.1. Typology of intervention units
125
129
8.3. Process of healthcare to the patients in the hemodynamics
and intervention office
9.
132
134
Arrhythmia and electrophysiology unit
137
138
9.2. Arrhythmia and electrophysiology unit
140
9.3 Electrophysiology office
141
144
10. Cardiovascular surgery service
10
130
8.4. Requirements of cardiac hemodynamics and intervention Unit
147
10.1. Cardiovascular surgery activity
148
148
10.3. Resources in cardiovascular surgery
150
10.4. Quality in cardiovascular surgery
153
11. Physical structure of the healthcare units of the cardiology
area
159
11.1. Functional program
159
11.2. Space relationship with other hospital units. Location within
the hospital
11.3. Specific physical resources of the UAC
160
160
12. Quality
195
13. Revision and follow-up criteria
199
Annexes
1. Groups related by diagnosis (GRD) of the cardiology area
201
2. Structural, process and results indicators of the emergency
system for the attention of patients with acute coronary
syndrome
3. Treating the patient with congestive heart failure
203
205
4. Requirements for a Primary Percutaneous Coronary
Intervention system (PCI-p)
5. Phases of the prevention programs and cardiac rehabilitation
215
219
6. Collaboration agreement between the SEC and the SERAM in the area of cardiology diagnostic imaging
221
7. Office of hemodynamics and intervention. Specifications
of the SEC
225
8. Dimensioning of the CCUs in a regional services network
237
9. Specific premises plan of the heart area
245
10. Equipment programme
249
11. Advanced training in hemodynamics and interventional
therapy. Criteria by the ESC and the SEC
12. Training requirements of an electrophysilogy cardiologist
265
273
13. List of devices and systems needed in an operating theatre
of cardiovascular surgery
277
14. Structural resources, systems and devices needed at the
post-operative intensive care unit of cardiovascular surgery
279
15. Specific needs of the hospitalization room for cardiovascular
surgery
281
16. Alphabetical index of definitions and terms of reference
283
17. Abbreviations and acronyms
291
18. Bibliography
293
11
Tables
1.1. Correspondence EMH 2005 -2007 and the CIE 9-MC. Diseases
of the cardiology area
26
2.1. Pathologies, techniques or diagnostic or therapeutic procedures
for which the designation of RCSU-NHS is necessary
32
2.2. Summary of incidence and prevalence of cardiovascular illnesses
in Spain. Studies based on adult population
34
5.1. Relationship between blocks of processses and healthcare units in the
heart area
75
5.2. Activity volume requirements by procedure
77
5.3. Population based structural requirements
78
5.4. Cardiologic healthcare regionalization
79
6.1. Standards by the BCS for the Coronary Care Units
99
6.2. Standards by the BCS for cardiovascular surgery
102
8.1. Typology of cardiac hemodynamics and intervention
126
8.2. Procedures excluded in the hemodynamics units that do no
have CVS (cardiovascular surgery)
128
8.3. Criteria for exclusion of patient discharge in 2-6 hours after
cardiac catheterization
131
8.4. Standards for cardiac hemodynamics and intervention units
133
8.5. Standards for cardiac hemodynamics and intervention units.
Vascular complications
133
9.1. Standards for arrhythmia and electrophysiology units
140
9.2. Estimated times for arrhythmia and electrophysiological studies
and treatment
140
11.1. List of areas and premises specific to the cardiology area
162
11.2. Function and structural features of the area for access and reception
of used materials
164
11.3. Function and structural characteristics of the consultation area
165
11.4. Function and structural characteristics of the special central
explorations zone
168
11.5. Function and structural features of the area for interventional
procedures
176
11.6. Function and structural characteristics of the day care hospital
area
186
11.7. Function and structural characteristics of the staff area
192
12.1. Managerial attributions of the CCUs network
197
12.2. Maximum delay time indicators for the SCAEST network
198
12.3. Quality indicators of the hemodynamics / intervention laboratory
198
12
A.2.1. AMI (acute myocardial infarction) emergency system: structure
indicators
203
A.2.2. AMI (acute myocardial infarction) emergency system: process
indicators
204
A.2.3. AMI (acute myocardial infarction) emergency system: result
indicators
A.7.1. Minimum suggested areas for the hemodynamics office
204
226
A.8.1. Dimensioning of the CCUs in the framework of a regional
level services network
238
A.8.2. Criteria for the calculation of CCUs' dimensioning
242
A.9.1. Premises plan of a CSU
246
A.10.1 Equipment plan of the CCUs by premise
249
A.12.1 Minimum training to be eligible for accreditation
275
Diagrams
5.1.
Relationship between healthcare units and processes
67
5.2.
Clinical pathway of congestive heart failure (CHF)
81
5.3.
Clinical pathway for acute coronary syndrome (ACS)
82
5.4.
83
5.5.
84
5.6.
Clinical pathway for syncope
8.1.
Circuit of patients after a catheterization
85
132
A.3.1. Ranking of chronic patients
206
A.5.1. Phase I: Hospital
219
A.5.2. Phase II: Ambulatory
220
A.5.3. Phase III: Maintenance
220
Pictures
6.1. Cardiological critical care unit: patient
100
6.2. Cardiological critical care unit: cardiovascular nurse station
100
6.3. Cardiovascular critical care unit: patients box
100
6.4. Cardiac rehabilitation ward
104
6.5. Cardiac rehabilitation ward (detail)
104
6.6. Consultation of cardiac rehabilitation
104
7.1. PET-CT room from the nurse station
118
7.2. Gamma-camera
118
7.3. MR from the nurse station
120
7.4. MR
120
7.5. Room for Diagnostic imaging reports
121
13
Executive Summary
Epidemic relevance of cardiovascular illnesses
1. In Spain, illnesses of the circulatory system are the principal cause of
death (22% of global mortality), the second cause of potential life
years lost and hospital mortality (hospital frequentation of 8.5 per
thousand inhabitants and year), and have a high prevalence among
chronic illnesses (5% of people over 16 years of age declared in 2006
having a chronic or long term illness in the category of acute myocar
dial infarction or other coronary illnesses). The coronary illnesses sus
ceptible to being treated in Coronary Care Units (CCUs) make up an
important healthcare burden in the hospitals of the National Health
Service (NHS), generating 10% of admissions and 11% of hospital
stays.
Coronary units as specialized healthcare resources
2. The patients treated at the CCUs fulfill two criteria: anatomical-physio
pathological and specialized, since they require the referral or the
shared management between primary and specialized healthcare.
3. The term «unit» is used throughout this document to refer to an organ
ized healthcare structure having an entity that depends on the group of
services and territorial range of the hospital where it is situated. This
definition of unit is based on the organizational and managerial con
cept, characterized by having a person responsible, human, physical
(premises, equipment) and financial resources, a services portfolio
(technical, procedural) to offer, final (patients) or intermediate clients
(other healthcare units) and an information system with process and
result indicators.
4. The CCUs participates in a transversal way in the healthcare process to
a patient with coronary health problems. A coherency shall be main
tained between diagnosis, therapy and care during all the process until
reaching the resolution of the problem.
5. In this document, the coronary area is ordered as clinical, imaging,
hemodynamics and intervention, arrhythmias and electrophysiological
and cardiovascular surgery . This order does not imply a hierarchic or
administrative hierarchy, rather a functional approximation to cover its
specifications in a systematic manner.
15
Patient rights and safety
6. The publication of volume and results of invasive procedures, whether
they be surgical or interventionist, is recommended using appropriate
methods of standardization. There is an outstanding variable in the
measure of procedures done, including those which entail a risk, as well
as in the measure of morbid mortality in the healthcare of patients with
a coronary pathology, when comparisons are made between centres.
Part of this variability is justified, while another part can be due to vari
ations in quality and safety in clinical practice.
7. The selection between therapeutic alternatives shall be subjected to the
search for the maximum evidence which allows for the best therapeutic
option to be advised for each patient. For this reason the following are
recommended:
• The interdisciplinary team discussion on the most complex cases,
including – for coronary revascularization – the clinical cardiologist,
the interventionist cardiologist and the cardiovascular surgeon
(«heart team»).
• The establishment of clinical management instruments (guides, IV’s,
etc.), based on scientific evidence and in whose development all spe
cialities and professional categories involved in the healthcare proce
dure have participated.
• The utilization of appropriate technical use criteria.
8. Periodical meetings of the CCUs team are recommended to analyze
with a systematic approach safety incidents which have occurred in the
unit, especially, to establish the pertinent prevention measures.
9. Standardizing planning on patient discharge is recommended,as well as
the introduction of balance practices of medication during healthcare
transitions. A priority objective of safety is increasing the efficiency of
communication among professionals involved in healthcare to patients
during transfer, especially in the referral between the hospital and pri
mary healthcare.
Regionalization and healthcare processes
10. The overall management of the healthcare process, the regionalisation
of CCUs and the creation of healthcare networks are the three most
important recommendations from the organizational perspective that
are given by this document in order to assure quality (including safety)
and effectiveness in cardiology healthcare.
16
11. It is recommended that no hospital be granted a cardiovascular or inter
vention service (hemodynamics or electrophysiology) which does not
have or expect to have, at the very least, the following activity:
• Percutaneous coronary intervention (PCI): 400 procedures a year,
per hospital, carried out by a minimum of two medical specialists. The
existence within the team of at least one intervention cardiologist
with an annual activity of a minimum of 200 angioplasties. PCI shall
only be done with surgical coverage; if the surgical service is in anoth
er centre, transfer time shall not exceed 60 minutes and an adequate
mechanism and procedure for transport shall be available.
• Aorta-coronary by-pass: Each surgeon shall do a minimum of 50
interventions of by-pass a year, in a centre where at least 600 major
surgical coronary interventions are done a year, by a minimum of
three trained surgeons.
12. The organization of the cardiac alert system shall focus on the health
care emergency system. The service/system of healthcare transport shall
be part of the CCUs healthcare network, its contribution being very rel
evant to the guarantee of patient access to the appropriate service, elim
inating unnecessary delays in healthcare and the establishment of initial
adequate healthcare measures.
13. The development of a healthcare network of CCUs is recommended to
improve healthcare to coronary patients, a concept introduced in the
strategy for cardiac pathology ischemia in the National Health System
(ECI-NHS). The functions to be developed by the network are the fol
lowing: drafting healthcare protocols; discussion on cases with a multi
disciplinary approach; guaranteeing healthcare quality and patient safe
ty; promoting the continuous training of professionals and the develop
ment of teaching and research, innovative and developmental activities.
14. Whether each of the healthcare units/services of the coronary services
integrated in the network maintains its own entity each or not, the
development and definition of a managerial structure for the CCUs
network is recommended.
15. It is recommended that the managerial structure of the network have an
associated organ in which all the units integrated in the network are
represented, a person responsible for the network and a person respon
sible for nursing.
16. It is recommended that the goal of the the CCUs’ healthcare network
and the regional reference services (interventionism, electrophysiology,
cardiovascular surgery) consists of an equal access for patients in the
17
territorial-geographic-population realm of the network, introducing
managerial instruments for demand management, quality guarantee,
etc.
17. The development of a heart failure unit is recommended to provide
support to the local hospital from the CCUs in the hospital of the
Health Area.
18. Shared hospital records, the use of ICTs and the transport system are
essential resources towards the development of the healthcare network.
19. The healthcare network shall have an information system based on
standards for documentation, name, exchange of data and images, to
guarantee the availability of the data for the making of clinical deci
sions, as well as for the communication with the hospital information
system, for public administration, financial data, etc.
Clinical resources and non-invasive technique offices
20. The resources linked to the CCUs include specific diagnostic and treat
ment units and those who have a multi-purpose and multidisciplinary
character (out-patient clinics, emergencies, conventional hospitaliza
tion, intensive care, day hospital, surgery) whose general characteristics
have been dealt with in other documents for standards and recommen
dations. Regarding the latter, this document develops their specifica
tions for the treatment of cardiac patients.
21. It is recommended that agenda logistics be established to facilitate the
strategy of a sole act. To this end, examination resources and common
equipment for the diagnosis of the cardiac patient (stress test, imaging,
echocardiograms), shall be physically concentrated whenever possible.
The rooms for non-invasive explorations shall be situated in the area of
external cardiac consultations, as they are closely related to them.
Diagnosis through imaging
22. Depending on the range of services and the population realm, the car
diac imaging unit shall have a person in charge; a specialist in cardiolo
gy, with a specialist’s level in echocardiography.
23. The rooms for echocardiography shall have an adequate and spacious
installation to enable complete studies to be done in their different
modalities and shall guarantee the safety of the patient and the person
nel who work in them. This document contains recommendations as to
18
the provision of human resources, performance and equipment of the
echocardiography, nuclear medicine and tomography and nuclear mag
netic resonance applied to cardiology.
24. The characteristics of access to gamma-cameras and detectors PET
equipment are similar to the echo-cardiograph offices, keeping in mind
that radioactive doses require that their location be circumscribed with
in the radioactive installation (field of nuclear medicine).
25. The equipment for magnetic resonance and computerized tomography
are found normally in the radiological service, requiring the collabora
tion among radiologist and cardiologists in the diagnosis through car
diac imaging to improve the indications of each examination, the per
formance in their interpretation and safety.
Hemodynamics and intervention
26. The annual rate of diagnostic studies is situated around about 3000
studies/million inhabitants, with a rate of about 2.700 coronagraphs
/million inhabitants.
27. The rate of coronary interventions, in 2008, was l.334/million of inhabi
tants, with a percentage of interventions in the IAM of 20.6% of the
total.
28. The development of the healthcare network (comprehensive emer
gency system) of PPCI is the recommended strategy to improve the
results in the handling of ST elevation acute coronary syndrome. The
data of the MASCARA study point out that there is a wide room for
improvement in the treatment of patients with acute coronary syn
drome in the Spanish healthcare system.
29. The following classification is recommended for the hemodynamics
units (HDUs): Reference intervention unit for the network; HDUs in a
hospital with no cardiovascular surgery service; and HDUs satellite.
30. The reference intervention HDUs has a regional realm (1-1.2 million
inhabitants) and its organization, human resources and equipment
allow it to develop an wide services portfolio. This unit shall incorporate
a primary percutaneous coronary intervention programme PCI-p),
being the reference for the accomplishment of PCI-p in acute coronary
syndrome with ST elevation, which requires that the HDUs be found in
the emergency system and that it guarantees permanent coverage (24
hours/7 days a week/365 days a year).
19
31. The HDUs shall be installed in a hospital with cardiovascular surgery.
Accessibility reasons derived from geographic and population condi
tions can justify having an intervention room in a hospital without car
diovascular surgery. The HDUs in a hospital without cardiovascular
surgery shall make agreements allowing the referral of a patient to a
service or unit of cardiovascular surgery in less than 60 minutes.
32. The hemodynamics and intervention unit shall have a person in charge,
a medical cardiology specialist, with advanced training in hemodynam
ics and interventional cardiology. This document contains recommen
dations about organization, endowment of human resources, perform
ance and equipment of the HDUs’.
Arrhythmia and electrophysiology unit
33. The increase in the number of patients to be seen in offices specializing
in arrhythmia, the use of non-invasive diagnostic technology, such as the
Holter, the swinging test or periodical control of implanted devices,
make it impossible to conceive the electrophysiological laboratory as an
isolated entity, rather that it make up part of the arrhythmia unit. Han
dling of a patient with cardiac arrhythmia is linked to the general con
text of his/her heart condition and therefore, each unit must only be
conceived of as part of the CCUs’s.
34. The rate of ablations in Spain is 512 per million of inhabitants, while the
estimated number of automatic defibrillator implants is 100 per million
inhabitants and year, being 75.5% primo-implants.
35. The arrhythmia unit is responsible for diagnosis, treatment and follow
up of the patient with cardiac rhythm disorder. In a centre where there
is a unit of pacemakers independent from the arrhythmia unit, the uni
fication of both of them shall be aimed for with the objective of opti
mizing material and human resources.
36. The arrhythmia unit shall have a person in charge, a physician special
ized in cardiology with an advanced training in arrhythmias and elec
trophysiology. This document contains recommendations about organi
zation, endowment of human resources, performance and equipment of
the arrhythmia unit.
Cardiovascular surgery service
37. The Cardiovascular Surgery Service (CSS) is an organization with a
hierarchy of specialists in cardiovascular surgery, which acts within the
framework of a hospital organization at a tertiary level.
20
38. The number of major procedures of CSS in the year 2008 was slightly
superior to 450 procedures per million of inhabitants. The distribution
by types of surgery showed 29% being coronary procedures, 41% valve
procedures, 10% combined procedures and 8% procedures to the aorta.
Paediatric surgery represented 9% of the total.
39. It is recommended that the number of major cardiac procedures be
over 600 cases per centre and year. The number of centres with CSS in
Spain has grown a lot during the last ten years, making this activity per
centre to be very reduced. In the year 2008 the average of major proce
dures per hospital was 371 cases. The atomization of the activity is an
important factor in the increase in costs and the reduction of quality.
40. The CSS service shall have a person in charge, a physician specialized in
CSS. This document contains recommendations about organization,
endowment of human resources, performance and equipment of the
CSS services, as well as the specifications of clinical multi-task resources
suitable to the needs of the CSS.
Physical structure of the CCUs
41. This document develops recommendations about the structural condi
tions of the specific areas of the CCUs’s, not normally integrated in
other healthcare units, such as the access area and reception, outpatient
offices, central functional examination offices, intervention (hemody
namics, electrophysiology), medical day hospitals and personnel.
42. The grouping of the specific areas of the CCUs is to be found within the
outpatient area of the hospital, in a location which permits treating out
patients or admitted patients. It includes the work zone of professionals
from that area, be it due to activity which is developed there or by con
stituting the nucleus of diagnosis and treatment in the coronary area.
43. The structure that is adopted in each hospital shall answer to functions
and criteria of organization and work, which will be established in the
corresponding work programme.
44. The work program establishes the dimension of the different areas
which integrate the CCUs and is elaborated after doing a demographic
analysis of the demand for resources linked to the services included in
the roster and different criteria of organization and function of the
coronary area, the definition of the healthcare process and the relation
ships with the rest of the units and services in its environment.
21
Quality indicators
45. This document recommends a group of structural indicators, processes
and results for the units, the healthcare network of the CCUs’s and the
establishment of a PCI-p.
Revision and follow-up criteria
46. It is recommended that a revision and actualization of this report be
done in a period of time not superior to three years.
47. It is recommended to:
– Do an analysis of the indicators of the CCUs’s that covers those con
tained in this report.
– Impulse the obligation of registering the cardiac interventions in
hemodynamics, electrophysiology and cardiovascular surgery.
– The publication, by hospital, of the volume and results of the invasive
procedures, surgical as well as intervention (hemodynamics and elec
trophysiology), using an adequate standardization method.
– The regionalization of the CCUs’s and boost the creation of health
care networks. The creation of networks for PCI-p is a strategic objec
tive for the improvement of the handling of the ST elevation acute
coronary syndrome.
– The creation of the health profession of technician in imaging diag
nosis in cardiology.
22
1. Introduction
The Law 16/2003, of May 28th, on cohesion and quality of the NHS, estab
lishes, in its Articles 27, 28 and 29, the need to establish safety and quality
guarantees that shall be requested for the regulation and authorization by the
Autonomous Regions for the opening and initial functioning of the respective
territorial area of the centres, services and healthcare establishments.
The Quality Plan for the NHS (QP-NHS) includes the strategy for
sanctioning and auditing centres, services and healthcare units, having as its
first objective the establishment of the basic common requirements and the
safety and quality guarantees that shall be fulfilled for the opening and
functioning of the healthcare centres of the NHS.
From the year 2007, in which the Ministry of Health and Consumers
(MSC) reviewed the guide of Major Ambulatory1 Surgery published in
19932, documents have been elaborated concerning the standards and rec
ommendations for the unit of medical and onco-hemotologicalhospitaliza
tion3, the unit for multi-pathology4 patients, maternity hospitalization5, the
surgical unit6, the unit for palliative care7, the nursing unit for multi-service
hospitalization of acute patients8, the units for hospital emergencies9 and
the unit for intensive care10.
Besides, the Ministry for Health, Social Policy and Gender Equality
(MSPSI) has a strategy for ischemic coronary pathology of the National
Healthcare System (ECI-SNS)11, and its updating has been approved by the
NHS Inter-territorial Council in 200912. This fact, together with the inci
dence and prevalence of cardiovascular illnesses in Spain, has made that the
NHS Agency of Quality (AC-SNS) to begin the drafting of the standards
and recommendations for healthcare units linked to the cardiology area, in
collaboration with scientific societies of cardiology, cardiovascular surgery
and nursing in cardiology.
1.1. Document scope
The illnesses of the circulatory system are in Spain, as in most of the devel
oped13 countries (they will probably continue to be so in the following
years14) the principal cause of death (124.126 deaths, 32% of the total, in
2007(1), the second cause of hospital morbidity and of potential life years lost
(1)
Source: INE (http://www.ine.es). Defunciones según causa de muerte. 2007. Own creationpia.
23
(19% of total) after tumours. In Spain, cardiovascular diseases make up the
third cause of the load of diseases (12% of the total AVAD). In Spanish hos
pitals they caused(2) in 2007 13% of admissions (610.449) and 15% of hos
pital stays.
In the NHS(3) hospitals they caused in 2007 14% of admissions
(510.000) and 16% of stays (3.700.000). It has a high prevalence among
chronic diseases (5% of people over 16 years of age declared in 2006 having
a chronic disease or one of long duration in the category of acute myocar
dial infarction or other heart disease)(4).
Primary healthcare and emergency devices are not specific resources
in the care of patients with cardiovascular diseases, therefore its profession
als shall have the competences to provide healthcare to a patient with car
diac disease, including prevention and control of cardiovascular risk factors.
The healthcare units in the coronary area (CCUs) are specialized resources
that specifically treat to this group of patients.
The R.D. 1277/2003, of October 10th(5), laying the general basis on
authorization of healthcare centres, services and establishments, defines and
enumerates the healthcare centres, services and establishments which must be
subject to requirements guaranteing their quality and safety and describe a
group of healthcare units, among which we can finf the following specific
resources for the treatment of patients with illnesses of the circulatory system:
– Unit 7 Cardiology is defined as an healthcare unit in which the med
ical specialist in cardiology is responsible for carrying out of the
study, diagnosis and treatment of cardiovascular illnesses.
– Unit 40 Cardiac Surgery, is defined as a healthcare unit in which the
doctor, specialist in cardiovascular surgery, is responsible for carry
ing out of the study and surgical treatment of cardiac pathologies.
– Unit 41 Hemodynamics, is defined as a healthcare unit in which,
under the responsibility of a medical specialist with experience in
hemodynamics, interventional vascular or cardiac processes for
diagnostic and/or therapeutic purposes are done.
The aforementioned units do not exhaust the healthcare resources
linked to treatment of patients with cardiovascular diseases. The concept of
(2)
Source: INE (http://www.ine.es). Encuesta de morbilidad hospitalaria. 2007. Own creation.
Source: MSPS (http://pestadistico.msc.es). Spanish National Healthcare System. 2006. Register of
the NHS hospital discharges. CMBD. Own creation.
(4)
19% said to have hypertension, 6% diabetes and 14% high cholesterol (multiple answer).
(5)
The classification of healthcare centres, services and premises was revised, in turn, by the Minis
terial Order 1741/2006.
(3)
24
CCUs incorporates the interaction and synergies between the specific
resources for cardiology and cardiovascular surgery, integrated in the
healthcare network, which guarantees quality, safe and efficient care of the
patient with cardiac pathology. For the cardiology area analysis, it is sug
gested to classify in clinical, imaging, interventional, arrhythmia and cardio
vascular surgery units This order does not make up a hierarchic or adminis
trative classification, rather a functional approximation to be able to con
front its specifics in a systematic manner.
Concept of the assistance unit
In the series of standards and recommendations for quality and safety in the
healthcare units developed by the MSPSI, the healthcare unit is defined as
an organization of health professionals that offers multidisciplinary health
care in a specific space, which fulfils the functional, structural and organiza
tional requirements, so that the adequate conditions of safety, quality and
efficiency to treat patients, who have specific characteristics, determining
the organizational and managerial specifications of the unit itself. This defi
nition of the unit is based on the organizational and managerial concept,
characterized by having responsible human, physical (`premises, equip
ment) and financial resources, group of services (technical, procedural) to
offer, final (patients) or intermediate clients (other healthcare units) and an
information system with process and result indicators.
This concept of unit is flexible, with relatively limited dimensions, as in
the case of multi-pathological or complex patients, as is the case of surgery.
Each healthcare service and centre must determine the final configuration
of the unit (including the CCUs), the relationship among them and with the
rest of the healthcare system.
Scope of the CCUs
The patient treated by the CCUs responds to anatomical/physiological cri
teria, because he/she has a cardiovascular disease which can be considered
to be in the cardiology area and a specialisation, since he/she requires the
referral (or the transfer) from the area of primary healthcare (non-specified
resources) to the specialized resources of cardiology and/or cardiac surgery
(specific resources).
25
Processes treated in the CCUsThe CIE-9-MIC is used as an instrument
of classification for the delimitation of diseases included within the scope of
the CCUs’s, for the spreading of its use and because it is the basis for the elab
oration of the groups related by diagnosis (GRD), main source of comparison
among hospitals, services, processes and procedures of the NHS(6).
In 2007 the specific processes in the cardiology area, using as criteria
belonging to the subgroup GRD, which appears in Annex 1, represented
10% of hospital admissions in the NHS, with a similar prevalence over the
total of stays (11%, for an average stay of 8.1 days) and somewhat higher in
cost (11.7% for an average cost of 4.506.587 Euros per admission)(7).
The problem of having an information system professional friendly
and that adapts to the length of the case and not only to the hospital admis
sion and the needs of the clinical management, crossing the borders
between primary and specialized care, has not been solved. The project for
digital clinical records in the NHS has opted for Snomed-CT(8). The use of
CMBD and GRD, in this context and in the CCUs’s, as an element of aid to
delimit the scope of illness/process/procedure and as an instrument of com
parison, is proposed.
(6)
(7)
(8)
26
http://www.msc.es/estadEstudios/estadisticas/cmbdhome.htm.
Source: http://www.msc.es/estadEstudios/estadisticas/cmbdhome.htm. Own creation.
http://www.msc.es/profesionales/hcdsns/areaRecursosSem/snomed-ct/snomedHCD.htm.
Specialization criteria
The patient with a heart disease is attended to in primary care, where nor
mally his diagnosis, follow-up and treatment occur. The technical recom
mendations of aid to the ECI-NHS point out the part that primary care
plays in aspects like the following(9):
a) Drafting protocols, between primary and specialized care, which
include recommendations for treatment, standards for bi-direction
al referral and a plan of check-ups in specialized healthcare.
b) Including healthcare of patients with high cardiovascular risk in the
services portfolio in primary care.
c) Establishing clinical routes (or integrated healthcare processes) of
healthcare to patients with diseases of the circulatory system, which
consider the action by each healthcare resource.
d) Developing and establishing healthcare networks for the patient
with cardio-pathology in terms of availability of resources and the
needs defined by the guides of clinical practice. All patients shall
have the opportunity to access a centre with non-invasive diagnos
tic techniques (echocardiogram, stress test, studies of myocardial
viability), hemodynamics and electrophysiology premises, and a
cardiovascular surgery service available. The access of patients to
these units shall have a protocol. The healthcare area with hospitals
without the aforementioned services, which are dependent on a ref
erence centre, will have a plan of action and the standards of refer
ral guaranteeing the fulfilment of objectives and time periods.
Emergency services are a relevant entrance to the health system for the
patient with cardiac disease. For this reason, the professional in primary care
and the emergency service shall have the capacity to aid the patient and per
forms other common processes that can be treated at this healthcare level,
including prevention and control of cardiovascular risk factors, diagnosis and
follow-up, and be able to apply adequate criteria for referral to the CCUs15.
The UAC attends to the patient who, suffering from any of the diseases
listed in chart 1.1 requires the intervention of specific resources in cardiol
ogy and/or cardiovascular surgery.
Within the scope of the document of standards and recommendations
of the CCUs aspects relative to children’s cardiology and vascular periph
eral are not considered (excluded from list of chart 1.1).
(9)
The following is an adaptation to the ECI-NHS’s technical recommendations with regards to the
stable angina, to extend them to all the circulatory system diseases.
27
The UAC has a relationship with other hospital units such as emer
gency service, hospitalization unit, day hospital, surgery, intensive care and
palliative care, whose documents of standards and recommendations are
available through the web page of the Ministry of Health, Social Policies
and Equality.
1.2. Document goal
The goal of the document of standards and recommendations for the units
in the cardiology area, is to make available criteria for the organization and
management of these units to the health administration, -private and pub
lic- managers and professionals, contributing to the improvement of safety
conditions and the quality of their practice, in the multiple dimensions of
quality, including the efficiency in the rendering of services, as well as for
their design and equipment. The aspects relative to the organization and
management are the objective of interest of the document, which do not
have as an objective the character of clinical guide. The CCUs’s are organi
zational and managerial structures which provide support to clinical prac
tice, which ideally shall be done through the systematic approximation con
templated in clinical guides, integrated healthcare processes, protocols, clin
ical routes and other instruments of clinical management.
The document of standards and recommendations of the healthcare
units in the cardiology area does no have a ruling character, insofar as it
does not establish minimum requirements or standards for the authori
zation to open and/or run these units or their accreditation.
1.3. Working methodology
The management of the project corresponds to the Office of Healthcare
Planning and Quality within the Agency of Quality of the National Health
care System of the Ministry for Health, Social Policy and Gender Equality.
The preparation of the document is done with the support of a group
of experts selected by the AC-NHS, based on the experience and knowledge
of them in the aspects related to the scope proposed, in collaboration with
the Spanish Society of Cardiology (SEC), the Spanish Society of Thoracic
28
and Cardiovascular Surgery (SECTCV) and the Spanish Association of
Nursing in Cardiology (AEEC).
The preparation of the document was scientifically coordinated:.
Alfonso Castro Beiras, Co-ordinator of the ECI-NHS y Carlos Macaya,
President of the SEC.
The AC-NHS was assisted by a company. It has acted as technical coor
dinator, secretariat and support to the group of experts, has followed up the
work, prepared and the revised the interim documents and analysed the evi
dence.
This document is supported by a extensive national and international
experience, listed in Section 17, and contains recommendations based on
requirement norms or evidence sufficiently solid under the criteria of the
group of experts who have collaborated in the writing of the same. When
these recommendations are made, they are expressly mentioned as such and
are highlighted in bold.
29
2. Situation analysis
A study by the National Centre of Epidemiology of the Institute Carlos III
that was published in 200616 points out that the morbidity of cardiovascular
diseases in Spain is not well known due to the non-existence of a stable,
exhaustive and reliable data source. According to this study, the yearly inci
dence of acute myocardial infarction between the ages of 25 – 74 years, ran
ged in men between 135-210/100.000 and, in women, between 29-61/100.000
not existing data on the prevalence of ischemic cardio-pathology. In a study
published in 1999, the prevalence of angina is estimated at 7.3% in men and
7.5% in women between 45 and 74 years17 of old.
In the study of the Oxford University on cardiovascular disease, it is
pointed out that ischemic cardiac pathology causes 17% and 16% of deaths
in men (17% of total) and in women (16%)13, as well as in people under 75
years old (20% and 19%, respectively) in the European Union. The number
of deaths by ischemic cardio-pathology standardized by age shows a geo
graphical gradient. The western most and Mediterranean countries (Spain,
France, Italy, Portugal, together with Belgium and Holland) show lower
numbers against the highest for the eastern most countries (old Soviet
Socialist Republics). The difference in mortality rates between ischemic
heart pathology and prevalence of cardiovascular risk factors are conside
rable among European countries13 and those corresponding to the use of
different therapeutic resources (hospitalization, invasive procedures, aortic
coronary by-pass, pacemakers and defibrillators) are even greater, indica
ting not only epidemiological variations but also access and clinical practi
ce. The geographic variability18 in clinical practice is also observed in Spain,
though the variability of the different procedures is low or moderate. There
is an important variability in the risk of dying from ischemic cardiac patho
logy in the NHS, part of which is attributed to the type of hospital in which
a patient is treated, being 25% higher for the IAM in hospitals that do not
have a CCU and 30% higher for the aorta-coronary bypass in those centres
doing less than 150 interventions a year.19
2.1. Standards and recommendations
There are two types of regulations: Those on authorization and register,
which assess a centre before it starts up, and those on accreditation, to eva
luate a centre once it started up.Both the general administration and the
31
autonomous regions have standards for authorization and register of
healthcare centres. Since RD 1277/2003 appeared, ten communities have
modified their autonomic legislation to adapt it to this new normative rea
lity, while another seven maintain the previous one. No standard of author
ization affecting the CCUs has been identified by the autonomous regions.
The Inter-territorial Council of the NHS has established the patholo
gies, techniques or diagnostic or therapeutic procedures for which services
or units of reference in the National Health System (RCSU-NHS)(10) have
been designated in the area of cardiology and cardiac surgery, which are
contained in Chart 2.1. The accreditation requirements of these units res
pond to the criteria of activity, human resources, equipment and information
system.
The experiences of accreditation of healthcare centres and services in
Spain are few. Four Autonomous Regions have standards and official
accreditation programmes for healthcare centres based on external and
voluntary evaluation: Anadusia, Catalonia, Galicia and Extremadura. In
some cases, there are accreditation programmes for some kind of centres,
services or activities (organ removal and transplantation, assisted reproduc
tion, haemotherapy, etc.).
Andalusia bases its accreditation system on the Programme for Centre
Accreditation(11), which is based on a reference pattern which contains a
series of standards among which there are none specifically referred to in
the CCUs.
(10)
Pathologies, techniques or diagnostic or therapeutic procedures for which designation of
RCSU-NHS is necessary. Area of Cardiology and Cardiac Surgery. Agreement of the NHS
Inter-territorial Council at its meeting of 22nd October 2009.
(11)
Resolution, of 24th July 2003, of the DG for Process Organization and Training, laying
down the quality authorization system for healthcare centres and units of the Andalusian
Public Healthcare System, in accordance with the quality model of the Andalusian healthcare
system.
32
Catalonia is the Autonomous Regions that firstly developed an official
procedure for the accreditation of healthcare centres. The present system is the
third(12), it regulates the accreditation of centres for acute hospital healthca
re and the authorization procedure of evaluating entities. It is completed
with two accreditation manuals with the established standards20,21. There are
no specific accreditation criteria for the CCUs.
Galicia established in 2001 an accreditation system for hospitals, regu
lated by decree(13), applied to hospitals pertaining to the healthcare network
of the Galician Healthcare Service or under contract. It does not include
specific accreditation criteria for the CCUs.
The accreditation system for centres in Extremadura of 2005, similar
to the models of Andalusia and Galicia, is oriented towards healthcare cen
tres, either outpatient or hospital ones in general, and makes no reference
to the CCU(14).
CCU Guides
The MSPSI as well as the Autonomous Regions have drafted guides for
some units, which, without having a normative character, pursue standardi
zation and establish recommendations on quality and safety. There is no
precedent in the MSPSI or in the former INSALUD of drafting of guides
on CCUs. The ECI-SNS, focused on healthcare processes, proposes some
quality standards related to the CCU organization and management in the
NHS. The guides published by the Autonomous Regions are focused on
healthcare processes. They do not specifically develop those related to plan
ning, design, organization and management of the CCUs, although some
quality standards effect them.
Andalusia has drafted the Integral Plan of Cardiac Pathologies Treatment22
and Integrated Healthcare Processes corresponding to stable angina23, thoracic
pain24, acute myocardial infarction25, acute coronary syndrome without ST ele
vation26, acute aortic syndrome27 and pulmonary thrombi-embolism28.
The Principality of Asturias has developed a guide of clinical recom
mendation about ischemic cardiac disease29, which focused more on clinical
aspects than on those relative to organization and management.
Galicia has developed the «Galician programme for the treatment of
acute myocardial infarction»30 with a similar focus as the one of the guides
of Andalusia and Asturias.
(12)
Catalonian Government Decree 5/2006, of 17th January..
Galicia. Decree 52/2001 of 22nd February.
(14 )
Extremadura. Decree 227/2005 of 27th September. Order 18th July of 2006.
(13)
33
Experience in Spain
Although there are deficiencies in the information and register systems of
cardiovascular diseases31, in chart 2.1 estimated data about their incidence
and prevalence in Spain is contained.
34
A study published in 200232 estimated that in that year about 68.500
acute myocardial infarctions (AMI) occurred (1.9 out of 100 inhabitants
over 14 years of age; or 4.2 out of 1.000 inhabitants over 44 years of age), of
whom 40.989 were hospitalized, while the rest died outside the hospital.
24.9% of the admitted patients wouldn’t have survived over 28 days. 33.500
were admitted with unstable angina, of which 4.5% died after three months
in the hospital. The same study estimated that, if the stable incidence would
have been maintained, the absolute number of cases of IAM would increase
to 2.28% annually in the population (9.847 cases in total) and the hospitali
zations for acute coronary syndrome 1.41% (8.817 cases in total) between
1997 and 2005.
With the data available in the data bases of the INE and the MSPSI, it
can be stated that illnesses susceptible to being treated in the CCUs (heart
diseases) cause 22% of global mortality(15)and make up a great healthcare
burden, as in the majority of developed countries13. They generate 10% of
admissions and 11% of hospital stays in the NHS hospitals. The estimated
hospital attendance for heart illnesses treatment is 8.5 per thousand inhab
itants and year(16). They have a high prevalence in chronic diseases (5% of
people over 16 years of age declared in 2006 having a chronic disease or one
of lengthy evolution in the category of acute myocardial infarction or other
heart diseases)(17).
All these data point out that an important part of the activity of the
CCUs is clinical (out-patients, emergencies, hospitalization); however we
should keep in mind the relevance of the invasive technique laboratories
(hemodynamics, intervention, electrophysiology) and of the non-invasive
techniques ones (electrocardiograms, stress tests, imaging diagnosis), which
very often give support for other healthcare units.
In 2007 the Statistics of Healthcare Establishments with Admissions
(EESCRI)33 reports the existence of 218 rooms (4.9 per each million of
inhabitants), 141 in public hospitals and 77 in private hospitals. The SEC is
the main source of data for resource and activity in the UAC.The register of
hemodynamics and cardiology of the SEC51points out that in 2007 196,688
(15)
Source: MSPS (http://pestadistico.msc.es). Causas de muerte CIE. 2007. Regarding the
group of diseases of the circulatory system, the ones excluded in Table 1.1 have been elimina
ted.
(16)
Source: http://www.msc.es/estadEstudios/estadisticas/cmbdhome.htm. Own creation..
(17)
Source: MSPS (http://pestadistico.msc.es). Spanish national survey on healthcare 2006.
19% said to have hypertension, 6% diabetes and 14% high cholesterol (multiple answer).
35
studies(18) were done in 129 hospitals (74 public and 55 private hospitals).
The combined data from the register of the SEC and the EESCRI points
out that there are 1.7 hemodynamics rooms per hospital (public – 1.9 rooms
per hospital – or private – 1.4-) and that 902 studies are done per year and
room (1.076 a year in public hospitals and 582 in private).
In 2007 136,231 diagnostic studies were done (@ 3.300 per million
inhabitants and year), with 122,260 coronariographies, which represents a
rate of 2,725 coronariographies / million inhabitants. The coronary inter
vention procedures performed were 60,457, with a rate of 1,347 intervention
/ million inhabitants. 94,966 stents were implanted, out of which 57,7% were
pharmo-active. 11.322 intervention procedures were done in the IAM,
which amounts to 18.7% of the total of percutaneous coronary interven
tions.
The facts from the register of 2008 offer similar data, with a rate of
coronary intervention at 1,334 per million inhabitants, an increase in inter
vention percentage in AMI (acute myocardial infarction) (20.6% of the
total)35, the coronariographies rate (2,658 +- per million inhabitants / year)
and diagnostic studies (2,956 per million inhabitants / year).
In 2007, the most frequent non-coronary intervention was done on
congenital cardio-pathology in the adult; the closing of intra-auricular com
munication is the highest number, with 334 procedures. Mitral valve-plasty,
with 367 cases treated and a success rate of 90.7%, is the percutaneous valve
procedure done most often. In 2007, 18 valves were implanted between pul
monary and aortic.
The figures of 2008 show that the number of mitral valvuloplasties
stays the same (37.1), with an increase in the success rate of this technique
(96%) and a noticiable increase in percutaneous aortic valve implantation
(151).
In the study on the experience of a reference centre with more than
17,000 angioplasties (percutaneous coronary interventions (PCI)) during the
period of 1986 – 200536, the number of PCI had increased significantly, modif
ying the profile of the patient. Age has increased (from 57 to 62 years of age
in men and 66 to 70 years of age in women), the percentage of those over 75
(18)
The EESCRI holds 196,583 studies; so we can assume that the SEC's register contains all
the hemodynamics units. The SEC's register points out the activity of 99% of those centres
carrying out interventional therapies in Spain. However, there are important differences bet
ween both sources with regard to the number of rooms registered: 218 (EESCRI) or 173
(SEC). This difference affects the calculation of performance per room, but not the rate of stu
dies per population. The performance calculation have been made with the EESCRI's data.
36
years of age (from 7 to 22%) and of women (from 16 to 22%). In women
modifications are not observed in risk factors while in men a reduction of
tobacco dependence, an increase of arterial hypertension, diabetes and hyper
lipemia are observed. In this period the number of urgent and emerging pro
cedures increased (17% of PCI in acute myocardial infarction in 2006).
The data from the MASCARA study point out that, in the Spanish
healthcare system37, there is an great improvement in the care of patients
with acute coronary syndrome. An inadequate implementation of guides,
the lack of confidence about the benefits of certain strategies and the exis
tence of logistical or structural problems38 are aspects which can explain the
less than favorable results compared to those expected with the introduc
tion of an early intervention strategy.
The register of pacemakers from the SEC39 received information from
106 centres, with a total of 11,939 cards, which is estimated at 35% of all
pacemakers which were used. The number of units consumed per million
inhabitants was 729, with a significant variation between autonomous com
munities, due to, in part, the inequalities of population structure. 27.2% of
the activity referred to in the register corresponds to changing of generators.
The average age of the patients who received their first implant was 76.6
years of age (75.9 in men and 77.5 in women). The decade object to the gre
ater number of primo-implants was in the 70’s, with 39.2% of the total,
followed by the 80’s (36.7%).
The SEC’s register of ablation40 collects information given by 59 cen
tres (49 of them public), where 8,564 ablations were done (512 per million
inhabitants) and an average of 145 ablations per centre. The information
given by this publication points out that: 76% of centres have rooms exclu
sively used for electrophysiology, 96% of the electrophysiology premises
were located in tertiary hospitals and 82% had cardiac surgery. It offered
data about the technical equipment of the premises.
In the SEC’s automatic implantable defibrillator register41 figures the
information provided by 134 centres (80 public ones). The number of
implants communicated was 4.108 (86.6% of the estimated total). The num
ber of implants per million inhabitants communicated was 89, being 100 per
million inhabitants and year the estimate. The amount of primo-implants
was 75.5%. 25.5% of total were automatic implantable defibrillators with
cardiac re-synchronization therapy.
The SEC has published a big amount of clinical practice guides, spre
ad through its Website(19) and the Spanish Magazine of Cardiology, which
(19)
www.secardiologia.es
37
includes aspects related to the CCU’s organization, management, human
resources, equipment and physical structure. The SEC’s documents specifi
cally developed to establish CCU’s technical requirements are the SEC’s
clinical practice guide on requirements and equipments in electrophysio
logy42, hemodynamics and interventional cardiology43; and outpatient moni
toring of electrocardiogram and arterial pressure44.
The register of the SECTCV(20) contains 15,178 interventions in adults
with acquired cardiac disease (excluding congenital cardiac diseases) with
extracorporeal circulation in 2008, which means a rate of 384 interventions
of this type per million of inhabitants over 14 years of age (420 if aortic
coronary grafts without extracorporeal circulation are added). 9.306
patients had valve diseases (61%) women while 3.821 patients received 1 or
more aortic-coronary implants (25%). The global mortality for extracorpo
real surgery in adults with acquired cardiac illness was 6.3%. 5.237 inter
ventions of coronary surgery were done (133 interventions per million
inhabitants and year), 27% without extracorporeal circulation with a global
mortality of 3.4%(21). 231 Cardiac transplants were performed (4 of them
cardiopulmonary) with a mortality of 15,5%. services were found on the
map of resources that SECTV offers which respond to the denomination of
«cardiac surgery» or «cardiovascular surgery», excluding those which are
denominated «vascular surgery» or «children’s cardiac surgery».
The European Society of Cardiology (ESC)(22) has also published
numerous clinical practice guides which, as in the case of the SEC, indicate
aspects with reference to organization, management and human resources,
as well as the equipment and physical infrastructure of the CCUs45.
The first data of the pioneer «heart institutes» (Clinical Hospital of
Barcelona, Juan Canalejo Hospital of La Coruña and the Clinical Hospital
San Carlos of Madrid)46,67, as well as other cardiology services48, have not
been updated.
(20)
www.sectcv.es
The SECTCV points out that the data reported on mortality for each variable or category
are not always complete. That is why they do not include the real mortality, corresponding to
all the services. Therefore, each mortality percentage that appears there must be interpreted
carefully, only as an indicative figure. In order to be able to compare data with other registers,
it is not mention if the mortality reported took place in a hospital or, as in the British register,
if it was 30 days after the surgical intervention.
(22)
www.escardio.org
(21)
38
The United States
In 2006 the prevalence of ischemic cardiac diseases in the USA was 7.6%
among people over 20 years of age and 3.6% for acute myocardial infarc
tion in this age group49, these rates considerably higher than the Spanish
ones. According to the data from the American Heart Association (AHA)
regarding patients admitted to hospital, this year the catheterization rate
was 3,700 studies per million inhabitants; the number of studies has thus
decreased in 4% since 1996. This year also, the rate of the PCAT (primary
coronary angioplasty trialist) was 4,400 per million inhabitants (70% phar
mo-active), the implanted pacemaker rate was @ 7,400 per million inhabi
tants and the implantable defibrillator rate was 382.(23).
The AHA(24) and the American College of Cardiology (ACC)(25) have
published numerous guides and other documents affecting the CCU’s orag
nization and management, quality and safety, planning and design. A recent
revision of the AHA and ACC’s clinical guides have pointed out that their
recommendations are mainly based on low levels of evidence or in experts’
opinions50. Among the guides which are more directly linked to the scope of
the document of standards and recommendation of the CCUs, the ones rela
tive to the hemodynamics rooms51, coronary surgery52, PCI53 and stress
tests54 can be mentioned. From the perspective of the «emergency systems»
development(26) the documents related to the «development of care of
patients with acute myocardial infarction»55 are of special interest.
The ACC and the AHA have elaborated documents about the clinical
competencies for the interpretation of electrocardiograms and Holter56,
echocardiographs57, electro-physiology58, imagery59, intervention60, preven
tion61 and stress tests62.
The AHA has developed a group «clinical performance measures»
related to the care of patients with stable angina, AMI, heart failure (HF) to
measure the quality of cardiovascular care89.
The AHA has developed a collaboration programme between hospi
tals («get with the guidelines») to improve the care of patients admitted
with ischemic heart disease or with HF, which includes a group of simple
quality measures linked to the AHA/ACC’s guides of clinical practice.
(23)
Las tasas son estimaciones propias a partir de las cifras proporcionadas por la AHA y la
población estimada por la OCDE en 2006 (298,755 millones de habitantesThe rates are esti
mations from the figures provided by the AHA and the population estimated by the OECD
in 2006 (298.755 million inhabitants).
(24)
www.americanheart.org
(25)
www.acc.org
(26)
Véase: Unidad de urgencias hospitalarias. Estándares y recomendaciones. AC-SNS. MSPSI.
2010.
39
The Agency for Healthcare Research and Quality (AHRQ)(27) of the
USA Government contains some quality and safety indicators linked to the
volume of activity for in- patients, which refer specifically to the CCUs’s64:
– 100 or more (threshold 1) or 200 or more (threshold 2) aortic-coro
nary bypasses per year.
– 200 or more (threshold 1) or 400 or more (threshold 2) PCI per year.
One of the outstanding interventions within the campaign «5 Million
Lives Campaign» of the Institute for Health Care Improvement (IHI)(28)
aimed at hospitals, is «providing the healthcare for acute myocardial infarc
tion based on evidence»65, it points out six key components in the care of
patients with AMI, which, at the same time, have been recommended in the
AHA/ACC’s clinical guide for the treatment of AMI.
The National Quality Forum (NQF) has published recently an upda
ting of safe practices for better healthcare66. These measures have been
included in the document of standards and recommendations of the multi
service hospitalization nursing unit for acute patients and are applicable to
in-patients in units of hospitalization linked to the CCUs.
United Kingdom
The United Kingdom has developed the ischemic heart disease strategy67
within the National Services Framework. The strategy, published in the year
2000, establishes standards for the improvement of care of patients with
ischemic heart disease, as well as the development of a system in health care,
protocols for referral, complementary examinations, treatment and follow
up: In relation to the CCUs, it establishes the following standards:
Coronarography: a minimum of 500 studies a year, per hospital, done
by a minimum of two medical specialists; each specialist shall do a minimum
of 100 cardiac catheterizations a year.
Interventions: percutaneous coronary (PCI) a minimum of 200 proce
dures a year, per hospitals, done by a minimum of two doctor specialists;
each doctor specialist shall do a minimum of 75 angioplasties a year. The
PCI shall only be done with surgical coverage and in hospitals where extra
corporeal circulation and be done in 90 minutes after the decision of surgi
cal referral. If the surgical service is in another centre, transfer time shall not
exceed 30 minutes.
(27)
(28)
40
www.ahrq.gov
www.ihi.org/ihi
Aortocoronary bypass: a minimum of 400 interventions a year, per
hospital, done by a minimum of three trained surgeons; each surgeon shall
do a minimum of 50 by-pass interventions.The last report (2008)68 available
on this strategy shows important achievements in the reduction of mortality
due to ischemic cardiac disease and a treatment improvement.
The study by Hacket (2003)69, epresenting the British Cardiac Society
(BCS), establishes the following criteria for the planning of CCU resources
in relation to population for the United Kingdom. 1 hemodynamics room
for each 400,000 or 600,000 inhabitants.
1 room for the implantation of pacemakers and defibrillators per each
1.3 - 1.5 million inhabitants, or 1 combined room per 350,000 - 400,000
inhabitants, if pacemakers and defibrillators are implanted in the same
hemodynamics room A combined report by the BCS with the Society of
Cardiothoracic Surgeons recommended the existence of a cardiovascular
surgery unit per 1.2 million inhabitants 70,(29).
A study by the BCS showed important variations within the United
Kingdom71 referred to the year 2002, in the provision of rooms (4.8 million
inhabitants in England compared to 2.7 in Wales), rate of coronarography
(average: 2.418 per million inhabitants), angioplasty (891) per million inhab
itants), aortocoronary by-pass (although the variability was less, 450 per
million), implantable defibrillator (30 per million, in England). The data of
2005 kept on showing important variations with a trend towards an increase
in the rates of activity by population (1,171 angioplasties per million inhab
itants)72.
The clinical guides developed by the National Institute for Clinical
Excellence (NICE)(30) or the Scottish Intercollegiatte Guidelines Network
(SIGN)(31) affect the CCUs’ organization and management, quality and
safety, planning and design.
In which figure standards for resources, activity and quality indicators.
At the same time, the studies by the BCS73 and the Royal College of Physi
cians74 can be of interest as a reference for the document of standards and
recommendations about human resources in cardiology.
A report by the National Confidential Enquiry into Patient Outcome
and Death (NCEPOD)(32),75 on coronary surgical practice in the United
Kingdom resulted in a series of recommendations which affect clinical han
(29)
As it is widely known, the NHS allows people to access (through Internet) knowledge of the
standardized rates of survival through coronary surgery in NHS hospitals.
(30)
www.nice.org.uk
(31)
www.sign.ac.uk
(32)
www.ncepod.org.uk
41
dling of patients as well as organizational aspects, such as reference and
admission systems, multidisciplinary planning of cases and complementary
explorations to be done. Another report from the same agency in relation to
the PCI (2000)76 agreed on a set of organization and clinical recommenda
tions.
The Health Building Notes77,78 provide relevant information about
planning and design of the CCUs.
La British Association for Nursing in Cardiac Care ha publicado los
Clinical Governance Peer Review Nursing Standards79.
42
3. Patient rights and guarantees
The hospital with a CCUs shall observe and respect the rights of the patient
contained in the current healthcare legislation. In this chapter figure aspects
about information to the patient and relatives of this unit and, in general,
those others included in the regulation and that shall be taken into consid
eration in this type of units and, where necessary, in the healthcare centres
where they are located.
3.1. Information to patients. Informed
consent
The implication of the patient in his/her own health is a relevant element in
all healthcare strategies. For this reason, as a general principle, information
shall be clear, precise and sufficient.
The information that shall be given to the patient / relative seen in the
CCUs will pay attention to the following aspects:
– Information about the general characteristics of the CCUs.
– Detailed information about care in the CCUs.
– Informed consent, with suppositions as laid down by law(33). The
Committee of Informed Consent of the Commission of Profession
al Issues of the SEC has made recommendations about procedures
where informed consent must be requested80.
– Other instructions and recommendations that are considered perti
nent about the use of hospital and CCU’s resources.
According to Article 5 of Law 41/2002, of November 14th, basic regu
lating on the patient’s the autonomy and rights and obligations regarding
medical information and documentation, the possessor of the right to infor
mation is the patients Information about the people linked to the patient
shall be expressly or tacitly authorized by him/her.
(33)
«It will be provided in written in the following cases: surgical intervention, diagnostic and
invasive therapeutic procedures and, in general, implementation of procedures that imply risks
or inconveniences and foreseeable negative repercussion on the patient’s health. The informed
consent is regulated by the basic regulating Law 41/2002, of November 14th, on the patient’s
autonomy, rights and obligations concerning medical information and documentation.
43
Information about the general characteristics of
the unit
Ordered information about the conditions that concern the stay of the
patient in the unit’s different resources shall be facilitated. Patient’s rela
tives shall receive this information orally and in written and it includes: vis
itation policy, medical information schedule, how to get in touch with the
nurse taking care of the patient, contact telephone, hospital services, etc.
Likewise, the patient, as long as his/her condition allows it, shall be
explained about his/her environment, the visitation policy, etc. in order to
minimize anxiety caused by his/her situation seriousness and the healthcare
environment.
Information about processes, his/her treatment and care.
It is recommended that the information provided to the patient con
tain the following sections:
– Adequate and understandable (without technical terms) explana
tion about the diseases that the patient suffer from and justify
his/her admission to the unit.
– Detailed explanation of the treatment procedures and care carried
out in the unit.
– The professional will inform the patient and his/her relatives about
the measures to be adopted as a consequence of the therapeutic and
care response. Depending on the importance of the measures to be
taken, the patient as well as his/her relatives will participate, when
ever possible, in decision making.
– Daily information will be given by the doctor responsible, or, in
his/her absence, by the designated person.
Informed consent
Carrying out of diagnostic and invasive therapeutic procedures, as well as
the administration of treatments implying risks or notorious inconvenienc
es and foreseeable negative repercussion on the patient’s health, will
require written consent, according to the provisions of thepertinent law.
It is recommended to have an informed consent form with particular
information for each diagnostic or therapeutic procedure with these
characteristics included in the services portfolio of the CCUs.
44
The performance of any procedure which implies a certain level of risk
shall have available a realm of necessary information so that the patient
and, if the case may be, the family/caregivers can know these risks and the
consequences of not assuming them.
The informed consent is regulated by Law 41/2002, November 14th,
basic regulator of the autonomy, rights and obligations of the patient as con
cerning clinical information and documentation. In it is defined as «the free,
voluntary and conscious conformity of the patient, manifested in full use of
his faculties after receiving the adequate information, so an act which affects
his health can take place. In each hospital an informed consent document
adapted to each activity and clinical speciality shall be elaborated.The
informed consent will cover specifically the aspects relative to the proce
dure to be carried out, including a minimum of information sections(34):
– Identification of the patient, the doctor who indicated and requests
consent, and the medical services will carry it out.
– Name, description and objectives of the diagnostic or therapeutic
procedure.
– General and specific personalized risks.
– Expected benefits and diagnostic/therapeutic alternatives.
– Intraining on the right to accept or refuse what is proposed and to
take back the consent already decided upon, and information of the
right to make explicit the limits which he thinks to be convenient.
– Date of consent.
– Differentiated section for the consent of the legal representative.
– Declarations and signature (patient and doctor).
– Confidentiality and use of data.
– The document will be emitted in duplicate (one copy for the patient
/legal guardian and another for the clinical record) and the patient
will be provided with a doctor to clear up or extend the information.
In the case of the necessity of any type of anaesthesia to enable the
procedure to be carried out, it is also precise that the informed consent
about the anaesthetic technique be obtained once the evaluation of the
anaesthetic risk has been carried out and the patient has been informed
clearly about the anaesthetic act.
The National Quality Forum (NQF) recommends requesting the
patient or legal guardian to explain in their own words the information rel
evant to the procedures or treatments for which their consent97 has been
requested96.
(34)
Comité de Bioética de Cataluña. Guía sobre el consentimiento informado. October 2002.
45
The hospital and the CCUs’s shall adopt explicit policies, guaranteed
by the Committee for healthcare Ethics, for healthcare to patients who, for
religious or any other reasons, refuse a certain type of diagnostic or thera
peutic82 intervention81.
The application of the right to informed consent shall be adapted to,
where appropriate, to the characteristics of the in-patient in the critical care
unit82.
Terminal situation(35)
In Spain, previous instructions have been regulated in Art.11 of the Law
41/2002, basic regulator of the autonomy of the patient, which define how
the document through which over age people manifest their will before
hand, with the objective of it’s being carried out in future situations in which
they cannot personally express their preference as to care and treatment of
their health83.
3.2. Guarantee of the rights of the patient
The hospital shall have available the following documentation and proce
dures, as well as the more specific ones included in section 3.1.:
a)
b)
c)
d)
e)
f)
Roster of services.
Reception plan.
Code of ethics.
The guides, ways or protocols for clinical practice and care.
Written procedures of clinical trials.
Fulfilment of norms about health products(36).
(35)
Check: Unidad de cuidados paliativos. Estándares y recomendaciones. AC-NHS. MSPSI
2009; and related documents of the ECP-NHS. http://www.msc.es/organizacion/sns/planCali
dadSNS/cuidadosPaliativos.htm.
(36)
R.D. 1591/2009 of 16th October, regulating medical devices. We understand as medical
device any instruments, appliances, equipment, software, materials or other items, whether used
individually or in combination (together with any software intended by the manufacturer to be
used for specific diagnostic or therapeutic purposes and that contributes to its good function
ing), which are intended to be used for human beings in the: diagnosis, prevention, monitoring,
treatment or alleviation of a disease; diagnosis, monitoring, treatment, alleviation or compen
sation for an injury or deficiency; research, replacement or modification of the anatomy or of
a physiological process; conception regulation; and which does not mainly work inside or on
the body through pharmacological, chemical, immunological or metabolic means, though it
may help to its function by such means.
46
g)
h)
i)
j)
Medical records.
Procedures about previous instructions.
Nursing and hospital discharge reports.
Protocols which guarantee safety, confidentiality and legal access
to patient data.
k) Complaint and suggestions book.
l) Insurance policy.
The right of access to these documents by the patients or persons
linked for family or de facto reasons shall be guaranteed, in the terms stat
ed in current legislation, except for those contained in sections d), e) and j).
The following develops, with special reference to the CCUs’s, some
aspects in relation to these rights. Sections 2) list of service, and g) clinical
records, are contemplated in chapter 5, of organization and management of
this document.
Reception program
The CCUs will have available a reception plan destined to the in-patient.
Code of ethics
The hospital with a CCUs will have available a code of ethics, in which there
are contained a group of ethical principles and rules which will inspire its
activity.
Clinical practic guides
As in the rest of hospital units and services, the CCUs will leave faithful docu
mental constancy of its guides, ways and protocols of clinical practice and care
which apply to each one of the services within the group of services, along with
their evaluations and, if the case may be, modifications and adaptations.
Procedures for clinical trials
The carrying out of clinical trials and other forms of clinical investigation shall
be subject to the conditions and guarantees established in specific legislation.
47
Price list
The hospital with a CCUs shall have a price list available to users, which
shall be communicated to the competent administration according the spe
cific norm on this matter.
Complaints and suggestions
The hospital will have, available to the user, complaint and suggestion sheets
which permit leaving constancy of his complaints, claims, initiatives or sug
gestions relative to the functioning which he considers convenient.
Their existence shall be in visible form and their location shall be the
most accessible possible for their identification and use.
The user of the hospital has the right to obtain an answer about the
complaints or claims presented, from the person responsible for the centre
or an authorized person, without prejudice of their remission to the compe
tent administration, in accordance to what is foreseen in the corresponding
autonomic norm.
Complaints, claims, initiatives and suggestions shall be the object of
periodic evaluation.
Responsibility insurance
The health professional who practices in the field of private health health
care, as well as the judicial person or entity of private ownership who offers
any kind of health services, shall have the prescribed responsibility insur
ance, guarantee or other financial guarantee, which covers the compensa
tions which could be derived from eventual harm to persons, caused on
occasion by the practice of said healthcare or services.
The hospital will have available responsibility insurance in accordance
with its activity to cover eventual compensations to which they must
respond for harm to the patient.
Policy files
The centre and, if the case may be, the health professional on his own part,
shall conserve a copy of the documents accrediting demanded responsibili
ty guarantees.
48
3.3. The right to information about
healthcare alternatives and its results
The information about healthcare alternatives and their results is a key ele
ment so the patient can exercise his right to decide on the option most com
patible with his values and chosen way of life. This information refers to, at
least, three fields(37):
– Public information about the results of the procedures offered.
– Normalization of the decision process of the procedures.
– The right to precise and complete information on the procedures,
including risks and benefits, be they short or long-term.
Information about the results of the procedures
There is an considerate variability in the rate of procedures being carried
out, including those which carry risk (invasive diagnostic studies, PCI, aortic
coronary bypass)18, as well as in the morbidity-mortality rate in the health
care to the patient with cardio-pathology when inter-centre19 comparisons
are carried out. Part of this variability is explained by epidemic, demo
graphic and social differences, and the diverse gravity of the patients attend
ed to, while another part can be due to non-acceptable variations in quality
and safety in clinical practice, associated to diverse factors such as the vol
ume of activity19, an inadequate implementation of guides or logistic or
structural38 problems.
In different countries (France, the United Kingdom, Sweden) of the
EU citizens have available some indicators of managerial healthcare (delay,
average stay, standard rates of mortality, etc.), broken down by centres. In
the United Kingdom standard rates of survival for cardiac interventions
(aortic-coronary bypass, aortic prosthesis and the total of cardiac surgery)
as well as the number of interventions done, breaking down both data (vol
ume and results) per centre and per cardiovascular surgeon. In September
of 2010, the Consumers Union of the United States published the results of
221 programs of coronary surgery84. The accessibility to this information to
citizens, extending it to other procedures (PCI, coronary-graphs, etc.), under
strict control and the with the objective of quality and its adequate stan
dardization, extends the right of the citizens to be informed and is, probably,
(37)
This section is based on the remarks provided by Dr. José Cortina.
49
a strong instrument of improvement for the quality and safety of cardiolog
ic healthcare in Spain.
The publication, by hospital, of the volume and results of invasive proce
dures, is recommended, be they surgical as well as hemodynamics and
electrophysiology, using the appropriate standardization method
(EuroEscore; Syntaxscore(1), 1, 1, others). These results shall be audited
with the participation of the scientific society to which they correspond.
Normalization of the decision process and the
procedures
The factors which influence the selection of a determined procedure are
multiple and some of these are not based on available scientific evidence.
This fact has a special relevance when very different therapeutic alterna
tives are available, as in the case of ischemic cardio-pathology (PCI as
opposed to coronary surgery) or congenital cardio-pathology (percuta
neous intervention as opposed to surgery).
The selection between therapeutic alternatives shall be subject to the
search for maximum evidence which permits advising the best therapeutic
option to each patient. In a recent study referring to the United States, buy
probably applicable to Spain, it is demonstrated how, in normal practice, a
high percentage of patients were treated with coronary intervention85, when
the procedural recommendation, according to guides, was surgical revascu
larization. The configuration of the cardiology area, in which multiple spe
cialties participate, permits a rigorous approach to this problem, through:
– The most adequate revascularization strategy for patients with
multi-vessel illness), by multi-disciplinary teams, including (for the
mentioned example) the clinical cardiologist, the intervention cardi
ologist and the cardiovascular surgeon («heart team»)45.
– The implantation of clinical managerial instruments (guides, clinical
ways, etc.) in whose development all the involved specialties and
professional categories have participated. (see section 5.5).
– The use of appropriate technology is another dimension in this same
aspect. The ACC has drafted adequate procedural criteria(38), which
(38)
50
http://www.cardiosource.org/Search.aspx?q=Appropriatness+criteria
cover from coronary revascularization86 to non invasive procedures
such as echocardiography87. The American College of Radiology has
published at the same time criteria on the appropriate use of diag
nostic imaging(39).
The right to precise and complete information on
procedures, incluiding risks and short or long-term
benefits
The informed consent does not guarantee in all cases the transmission of
information to the patient for his complete decision. The patient needs to be
adequately informed about the potential benefits and short or long-term
risks of the possible therapeutic alternatives (for example PCI or surgery)
and needs enough time to permit him a decision based on the information.
The concatenation of the diagnostic and therapeutic procedures, without
the solution of continuity shall be restricted to emergency situations, in the
interest of a balanced decision on the part of the patient.
(39)
ACR Appropriateness Criteria® www.acr.org/SecondaryMainMenuCategories/quality_
safety/app_criteria.aspx.
51
4. Patient safety
The advances in medicine produced in the twentieth century have modified
the prognosis and the treatment of many diseases. However, this evolution
has been accompanied by an enormous increase in the complexity of spe
cialization and the segmentation of healthcare, which implies greater risk
and possible unnecessary harm to patients. The providing of health health
care entails some unacceptable risks in comparison to other activities or
even other situations considered to entail risk. With the exception of mor
tality derived from anaesthesia, hospitalization as well as the exposition to
medication in the hospital, are associated to avoidable mortality88.
Assistance errors have grave consequences for the patient and his
family, generating a very elevated healthcare and financial cost, eroding the
confidence of the patient in the system, and damaging health professionals
and institutions who are, without a doubt, the second victim. For this reason,
patient safety constitutes today a priority for principal health organizations,
as well as the World Health Organization89, international organisms, like the
European Union90 and the Council of Europe91, health authorities, profes
sional societies and patient organizations.
In Spain, the MSPSI in its responsibility to improve the quality of the
health system in its whole, as marked by Law 16/2003 for cohesion and qua
lity of the NHS(40), has considered patient safety to be a key quality compo
nent and has situated it in the centre of its health policies. In this manner it
is reflected in strategy number eight of the Quality Plan of the SNS92, whose
objective is to improve patient safety attended to in health centres of the
SNS through different acts, among which can be found: to promote and
develop the culture and knowledge of patient safety between professionals
and patients; to design and establish notification and information systems of
EA for learning; and implant safety practices recommended in the SNS cen
tres. This strategy is based on recommendations by the World Alliance for
Patient Safety of the OMS and other international organisms93.
The documents of standards and recommendations elaborated by the
AC-NHS of the MSPSI, referring to major ambulatory surgery, day hospi
tals, surgery, multi-service nursing units for the hospitalization of acute
patients; hospital emergency units and the intensive care unit, include the
recommendations for patient safety, applicable to the CCUs. In this chapter
some more general aspects will be treated.
(40)
Ley 16/2003, de 28 de mayo, de cohesión y calidad del NHS. BOE n.º 128 (29-5-2003).
53
It shall be pointed out that the implantation of some of the basic prac
tices of patient safety, such as the availability of clinical records or electro
nic prescriptions, is determined by the CCAA policy or the hospital where
the CCUs is located.
The National Quality Forum (NQF) has published recently an actuali
zation of safe practices for better health healthcare. Most of the 34 safe
measures recommended by the NQF are applicable to the CCUs, among
which we can find:
• Referred to in section 3.1.3.
• Vital support treatment. To assure that the patient’s preferences in
relation to vital support treatments are displayed distinguishably on
his clinical follow-up sheet.
• Transparency. If unexpected grave results are produced, including
those which have clearly been produced by organizational errors,
the patient shall be informed and, if adequate, the family in an
opportune, transparent and clear manner about what is known
about the event.
• Attention to the provider of the healthcare. If unforeseen, uninten
tional grave harm is produced due to organizational and/or human
error, the provider of healthcare involved shall receive the opportu
ne and systematic healthcare, which shall include; fair treatment, res
pect, compassion, support medical healthcare and the opportunity to
participate completely in the investigation of the event, identifying
the risk and development of activities which reduce the risk of futu
re incidents.
• Nursing human resources: To implant a well designed policy of criti
cal components of human nursing resources which strengthens
patient safety.
• Other direct care providers. To assure that direct care provider
resources, who are not nurses, be adequate, that the personnel is
competent and they have an adequate orientation, training and edu
cation to carry out their activities of direct care.
• Intensive care unit(41). All patients attended to in the CCU shall be
managed by doctors who have the specific training and the adequa
te professional competence in «critical care».
• Information about patient care. To make sure that the information
about healthcare is transmitted and documented in the opportune
(41)
The application of this criterion to the Cardiovascular Critical Care Units is done in section
6.1.5.
54
manner and clearly understandable to the patient and to all the pro
viders of healthcare who need the information to be able to render
continued healthcare, within and between health services.
• Verification of orders and abbreviations. To incorporate within the
health organization systems, safe communication structures and
strategies. For those verbal or telephone orders, or telephone com
munications which inform about the results of an important test, the
verbal order or the test results shall be verified making the person
who receives the order or communication repeat the complete order
or result. To standardize a list of abbreviations, acronyms, symbols
and dose denominations which cannot be used in the organization.
• Labelling of diagnostic studies. To implant normalized policies, pro
cesses and systems to assure safe labelling of x-rays, lab specimens
or other diagnostic studies, guaranteeing the study corresponds to
the patient.
• Release system. The patient shall have a discharge plan available.. A
concise summary shall be prepared, which shall be transmitted to
the doctor who afterwards has healthcare responsibility, assuring its
reception. Adoption of computerized prescription systems. Agree
ment for habitual patient medication through care continuity.
• Pharmacy managerial structure. The person responsible for the
Pharmacy shall have an active part in the management team which
reflects his authority and responsibility concerning the functioning
of the management system for medication within the organization.
• Hand hygiene.
• Flu prevention for health service personnel.
• Infection prevention associated to central catheters.
• Infection prevention of the surgical wound site(42).
• To adopt measures to prevent complications associated concretely
with mechanically ventilated patients, pneumonia associated to
mechanical ventilation, venous thrombi-embolism, peptic ulcers,
dental complications and bedsores.
• Infection prevention for multi-resistant organisms.
• Infection prevention associated with urinary catheters.
• Prevention of mistakes in the location of the surgical area, in the
type of procedure or in the patient identification(43).
(42)
This aspect has been widely dealt with in: Bloque Quirúrgico. Estándares y recomenda
ciones. AC-SNS. MSPS. 2009.
(43)
This aspect has been widely dealt with in: Bloque Quirúrgico. Estándares y recomenda
ciones. QA-NHS. MSPS. 2009.
55
• Prevention of bedsores.
• Prevention of venous thromboembolisms.
• Prevention of EA derived from anti-coagulant treatments.
The AC-NHS has evaluated safety practices recommended by govern
mental agencies for prevention of EA in patients attended to in hospitals
according to their implant and the complexity of their implantation94.
Improvement of hand hygiene; flu vaccination of workers and patients;
measures to prevent pneumonia (nosocomial pneumonia) associated to
mechanical ventilation; measures related to the prevention of infections in
the surgical area; the use of color codes to cleaning teams and materials to
prevent infections.
Single use injection material; measures to prevent infections in central
IV’s; measures to identify all high risk medication, as well as the establish
ments of policies and processes for the use of this medication; measures for
the prevention and correct treatment of acute myocardial infarction in rela
tion to surgical procedures; promotion of safety measures for the adminis
tration of oral or other IV medication; measures for the control of surgical
procedures being carried out in the correct location; measures to promote
the safe use of medication administered by injection or administrated
through an IV; precaution measures referring to the use of physical con
tention or immobilization of patients.
Recommendations to prevent problems related to the administration
of medication with an appearance or name which can lead to confusion;
measures to assure the precision of medication in healthcare transfers
(between doctors, hospitals, etc.); measures for a correct communication
during the transfer of patient health information; identification of patients;
evaluation of the risk of developing bedsores; evaluation of the risk for
thrombi-embolism; measures to assure that written documentation with ter
minal patient preferences on treatment be highlighted on the care plan;
measures to guarantee patient safety concerning those with high complexi
ty allergies to latex.
Some of the «safety practices», among the recommendation by the
NQF or selected by the Agency for Quality of the NHS, applicable to the
CCUs’s, are commented in greater depth in the sections of this chapter.
4.1. Safety culture
The creation of a safety culture is considered to be a decisive step towards
the achievement of patient safety and constitutes the first safety practice
recommended by the Health Committee of the European Council, the
56
National Quality Forum and other organizations95,96. According to the US
Department of Veterans Affairs a safety culture could be understood as «all
those characteristics of an organization, as well as the values, philosophy,
traditions and customs which lead to a continuous search behaviour, be it
individually or as a group, for the manner to reduce to the maximum the
risks and harm which can be produced during the different processes of ren
dering health healthcare97.
A safety culture is essentially a culture in which the work organization,
processes and procedures are focused on improving safety, and where all
professionals care are made aware constantly and actively of the risk that
errors be committed, or in other words «that something can go wrong», and
that they play a part and contribute to patient safety in the institution. It is
also an open culture, where professionals are aware that they can and must
communicate their errors; that you can learn from errors that happen and
that measures are taken to prevent that those errors be repeated. (learning
culture).
A safety culture shall be encouraged and maintained in the hospital
where the CCUs is located. This entails the development of the following
actions96:
– To establish and maintain leadership which promotes the safety cul
ture.
– To periodically evaluate the safety culture of the instruction, com
municate its results and take measures to improve it.
– To form professionals in teamwork techniques and principles for the
reduction of error.
– To establish notification and learning programs, to identify and ana
lyze incidents produced and risk situations, and apply and evaluate
actions of improvement in relation to the same.
Periodical meetings shall be held with the CCUs team to analyze with
a systematic focus the safety incidents which have occurred in the unit, and
especially, to establish the pertinent prevention measures98.
A pro-active risk analysis shall be carried out (through Modal Analy
sis of Errors and Effects – AMFE – or similar) concerning those procedures
which make up the greatest risk for the units, in order to identify possible
errors which can exist and implant measures to solve them.
It is recommended that a proactive analysis be carried out al least once
a year and each time a new risk technique or procedure is introduced. Pri
mary care communication flow shall be encouraged with respect to patient
safety topics, including the regular decision of safety incidents registered
and the review of patient safety topics in meetings and group sessions with
primary care.
57
Formation of professionals on the topic of safety shall be encouraged,
including safety topics on safety in reception programs and continuous
training.
Safety information about the patient shall be brought up to date regu
larly along with practices based on scientific evidence proving their effi
ciency in the reduction of errors, in order to evaluate the introduction of
new methods which can be useful and establish continuous improvements
regarding the safety of patients attended to the unit.
4.2. Communication during patient transfer
Throughout time, a patient can, potentially, be attended to by a series of dif
ferent professionals in multiple units, including primary care, specialized
ambulatory healthcare, emergency healthcare, hospital and rehabilitation
healthcare, among others99. Additionally, he can find (in determined health
care modals) up to three personnel shifts per day.
Communication among units and among healthcare teams at transfer
time could not include all essential information, or could be subject to an
incorrect interpretation of the information, which would mean a safety risk
for the patient. Besides, the elderly patient or the multi-pathological patient
is particularly complicated and for that reason more vulnerable to breaches
of communication during the transfer100 which lead to EA.
Communication at the time of transfer is related to the process of pass
ing specific patient information from one healthcare provider to another
and from one team of providers to another, or from healthcare provider to
the patient and his family assuring the continuity and safety of patient care.
To increase the effectiveness of communication among professionals
involved in patient healthcare during transfer is the priority safety objective
for leader groups in safety like the OMS101, the Joint Commissions102 and
the National Quality Forum96.
It is recommended that communication among professionals during
transfer time, shift changes and different healthcare units be standardized in
the course of patient transfer to another unit or healthcare field. For this
reason the assigning of sufficient time to communicate important informa
tion and to ask and answer questions without interruptions is recommend
ed; and the use of the SBAR193: technique; model of common language to
communicate crucial information, structured in 2 sections: S = Situation; B
= Background; A = Assessment; R = Recommendation.
The standardization of the discharge plan is recommended to guaran
tee that at the time of hospital discharge, the patient and his next health
58
healthcare provider obtain key information referring to the discharge diag
nosis, treatment and care plans, medication, and test results. For that reason
the use of checklist96,104 is recommended to verify the efficient transference
of the principal elements of key information to the patient as well as to the
next health care provider.
4.3. Safety in the use of medication
Medication constitutes the most frequent health intervention, so that it is
not rare for it to be one of the principle causes of EA in health care, in the
hospital as well as the ambulatory field. In our country, the ENEAS and
APEAS studies revealed that medication was the cause of 37.4% of EA
detected in hospitalized patients and 47.8% of ambulatory patients105,106.
A great part of medication errors are produced in the process of
healthcare transition, fundamentally due to problems in the communication
of information concerning medication among responsible professionals or
among those and the patients. These errors give way to up to 20% of adverse
hospital incidents and an important percentage of hospital re-admissions
107,108
. For that reason, presently it is recommended that the implantation of
conciliation practices for medication in healthcare transitions96,109, be
encouraged, very especially the conciliation upon admission and when there
is a change from intravenous to oral therapy in dose and schedule.
4.4. Safety in the use of health products
R.D. 1591/2009, October 16th, by which health products are regulated, antic
ipates the obligation of health professionals and authorities who, during
their activity, become aware of any defective functioning or alteration of
characteristic or use of health products, as well as any inadequate labelling
or use instructions which can provoke or has been able to provoke the death
or grave deterioration of the state of health of a patient or user.
The health centre shall designate a person responsible for the surveil
lance of the procedures which are derived from the application of the afore
mentioned incidents in the previous paragraph, who will also supervise the
fulfilment of the obligations established by RD 159/2009 in relation to the
implantation of cards for health products.
The person responsible for surveillance will communicate the data to
the health authority in the corresponding autonomous community and the
Spanish Agency for Medication and Health Products.
59
4.5. Prevention of bedsores
The bedsore is a frequent complication at any level of health healthcare,
especially in the elderly patient with mobility problems. The bedsore delays
functional recuperation, can become complicated with infection/pain, low
ers life quality for the person suffering from it, and contributes to prolong
ing the hospital stay and the cost of health healthcare.
Prevention is the key to a reduction in bedsores. The implementation
of interventions based on the evidence for bedsore prevention is a priority
in the international field of Patient Safety, being one of the safety strategies
of the NQF110, on of the national safety objectives (National Patient Safety
Goals) proposed by the Joint Commission for 2009, and one of the selected
strategies by the Institute of Healthcare Improvement in its national cam
paign to protect the patients of five million adverse incidents «5 Million
Lives Campaign»111.
Bedsore prevention in risk patients is one of the specific areas of safe
ty practices which the MSPSI promotes through agreements with
autonomous communities, within the PC-NHS.
Patient care in the CCUs shall include bedsore prevention, with the
identification of risk of development and the evaluation of the state of the
skin:
– Carry out an admission evaluation of all the skin, and from there
carry out a daily inspection, or more frequently depending on its
state.
– To evaluate risk clinical judgement and standardized instruments
(Braden, Norton, EMINA scales) shall be combined and establish
the opportune care according to calculated risk.
– Re-evaluate the patients regularly and document any findings in the
clinical record.
The pressure tolerance of the tissue shall be maintained and improved
through exploration and treatment of the factors which affect tissue toler
ance (age, vascular competence, glucemia control in diabetics, nutrition) to
prevent lesions.
The individualized care plan shall include localized skin care (hygiene
and hydration); the specific prevention in the incontinent patient; postural
changes in the patient with limited mobility; the use of special surfaces in
the bed and /or seat of the patient to alleviate pressure; on site protection
against pressure in bone prominences; skin protection from movement and
friction forces through adequate positional techniques, transfers and pos
tural changes.
60
The continued training of health professionals linked to the CCUs
shall include the prevention and treatment of bedsores.
4.6. Infection prevention
Hand washing is probably the most costly measure – effective in reducing
nosocomial112,113. The MSPSI has elaborated a publication in which the
directives of the OMS on hand hygiene in health attention115 are summa
rized114.
The Society for Healthcare Epidemiology of America (SHEA) and the
Infectious Diseases Society of America (IDSA) has recently published a
group of recommendation to develop prevention practice for nosocomial
infection115, in which the Association for Professionals in Infection Control
and Epidemiology (APIC) and the American Hospital Association (AHA)
have participated, in reference to: Prevention of infection by central venous
catheter116; prevention of pneumonia associated to a respirator117; prevention
of infection associated to a urinary catheter118; prevention of infection in the
surgery site119; prevention of infection by meticilin120; resistant Staphylococcus
aureus, and prevention of infection by Clostridium difficile121.
The CCUs’s will have a surveillance and prevention program for noso
comial infection, adapted to their characteristics and activity, which guaran
tees risk patient identification and risk procedures, as well as the informing
of the competent authorities, in accordance to current norms.
4.7. Epidemiological alert
The hospital with a CCUs will have an epidemiologic alert connected to the
competent health authorities, in accordance to current norms.
4.8. Patient identification
In a recent study, promoted within the patient safety strategy of the NHS,
the following recommendations were made to in-equivocally identify a
patient122:
– Promote, at least, two identification factors, surnames and name,
birth date, clinical record number, health card number.
61
– None of these shall be the bed number.
– Use an automatically printed identification number.
– Elaborate and spread protocols which contemplate clear criteria for
the identification of patient not identifiable or to differentiate those
who have the same name.
– Promote the labelling of patient samples in the moment of extrac
tion.
– Establish controls to prevent the incorrect selection of a patient in
the perpetual clinical record.
– Form personnel in the adequate identification procedure for
patients and the necessity of their verification confronted with any
risk intervention.
– Transmit to professionals the necessity to check the identity of
patients and certify that it is the correct patient and the indicated
procedure before carrying it out.
– Incorporate the patient and his family actively in the identification
process.
– Do a periodical follow-up of the identification process in in-patients.
4.9. Management of hemoderivatives
The management and safety of hemoderivatives is competence of the cen
tre’s blood bank, which shall be accredited to do so(44).
The in-equivocal identification of the receiving patient shall be assured
previous to the taking of samples and, once again, before a blood or hemod
erivative transfusion.
The traceability of the transfusion process shall be assured and respon
sibilities delimited in the perfusion of hemoderivatives between the blood
bank and the CCUs.
(44)
RD 1088/2005, laying the «technical requirements and the minimal conditions of blood dona
tion and of the transfusion service centres» and RD 1301/2006 of November 10. laying the «qua
lity and safety regulations which regulates all activities related to the used of human tissue».
62
4.10. Patient safety and health risk
management(45)
Good practices in terms of patient safety require a managerial safety organ
ization. Health centres shall develop efficient systems to assure, through
clinical management, a safe healthcare and learn lesions from their own
practice and that of others. The risk management processes are relevant to
this policy, including the revision of organizational culture, risk evaluation,
training, protocols, communication, audits and learning of adverse effects,
reclamations and complaints.
In the hospital, dependent on healthcare management, a commission or,
if the case may be, a unit in charge of identification and register of adverse
effects which are produced as a consequence of health care, will exist, as well
as the application and evaluation of improvement actions in relation to the
same.. Risk management shall be supervised and coordinated by the CCUs’s
own managerial group, presided over by a «senior» doctor and a multidisci
plinary representation, who shall meet periodically (at least once every six
months). This group shall have sufficient training to apply different necessary
tools for safety management and transmit at the same time the necessity to all
the personnel of the unit. The risk managerial process shall be in writing,
including the warning events of obligated knowledge and revision, and promote the multi-disciplinary training of risk management.
There shall be a proactive and continuous risk evaluation within the
unit, together with a formal risk evaluation, with a minimum periodicity of
two years. The evaluation process shall derive an incident register where
known and analyzed incidents are contained, the work done and the meas
ures adopted in each case with later evaluations of their utility, guarantee
ing the total confidentiality of the data. When adverse events are produced,
the health centre shall consider the causes and consequences of the identi
fied problems. The opportune analysis of the subjacent problems with an
appropriate plan of action shall be a part of the learning process and
implantation of change.
Regular audits of surgical adverse effects shall be carried out. Meet
ings to review adverse effects form a part of the risk management system, as
well as the learning process of the CCUs. Good communication with all pro
fessionals involved in any incident is an important mechanism to reduce the
possibility that the adverse effect take place again.
(45)
This section is widely based on the one of the same statement, of the document: Bloque
Quirúrgico. Estándares y recomendaciones. AC-SNS. MSPSI Madrid. 2009.
63
Total transparency shall be maintained in relation to learning results,
through multidisciplinary meetings and feedback through electronic or
paper communication. While many incident revisions will identify changes
in practice and systems which will probably improve the results without an
increase in costs, some can quire changes which precise major resources. The
responsible parties of administration and management in the centres shall
be informed of these necessities. The support of the centre management is
fundamental as well as the leaders of the CCUs for the safety managerial
strategy to be effective.
The results and standards measures shall be adopted, audited and pub
lished as an annual report in line with an improved practice.
It is important that doctors adequately document the incidents; date
and location. It is crucial, to improve clinical practice, to have systems for
documentation and register of clinical decisions and incidents. The filing of
all the data is vital. A person within the CCUs, preferable the risk manager,
shall be responsible for assuring that the adequate methods be adopted.
There are different safety management tools in the CCUs, almost
always framed within quality programs.
Notification systems as well as analysis techniques and risk evaluation,
as in the Method of Analysis of Errors and Effects (AMFE), the analysis of
root cause and other techniques (briefing, etc.) have demonstrated their
usefulness in risk management.
Guaranteed judicial confidentiality shall be promoted for the identifi
cation and signature of the notification.
4.11. Volume of activity and safety threshold
There is sufficient scientific evidence to establish a relationship between
mortality and/or morbidity and volume of hospital and professional activity
in determined medical and surgical procedures123,124,125,126,127,128,129. The rela
tionship between volume and results has been demonstrated at the same
time for medical processes, such as acute myocardial infarction, cardiac
insufficiency and pneumonia130. Among these procedures aortic-coronary
bypass and ICP129 are found.128
Although the relationship between the volume of aortic-coronary
bypass surgery and quality is demonstrated, the volume of procedures is
solely modestly associated with surgical results131, existing centres with low
volumes of activity and excellent.results132. Taking into consideration this
fact, Luft123 points out that «since the volume «per se» does little more than
assure reasonable confidence intervals around statistical estimates, the poli-
64
cies based on excluding or closing centres based on their activity are inferi
or to those based on ordinary information concerning results adjusted to
risk, referring those patients to those centres with better than expected
results133 (see section 3.3.1). Using the same criteria, Nallamothu and
Eagle134, promote regionalization with the following criteria:
• Eliminate the cardiac surgery programs with a very low volume of
interventions (less than 100) (including aortic-coronary bypass and
other open heart cardiac surgery).
• For hospitals with annual volumes of cardiac surgery above 11 cases,
shall use additional criteria to evaluate quality, such as mortality
rates adjusted to risk(180). When the annual volumes of cardiac sur
gery are from 100 to 250 cases, the referral of high risk patients (peo
ple over 65 years of age or complex procedures such as concomitant
valve replacement) shall be seriously considered.
• Develop a mandatory state system for collection of data to obtain
information on quality and results in hospitals where cardiac surgery
is carried out.
Evaluate the adequacy of the intervention.
It is recommended that the services of cardiovascular surgery or hemody
namic intervention not be granted to those hospitals that do not have a ref
erence population area (or whose market study does not foresee it) as a
minimum the following activity:PCI (Bashore y cols.51; Canto y cols, 20001):
400 procedures a year, per hospital, carried out by a minimum of two doc
tor specialists. The existence within the team of at least one intervening car
diologist who commands all the cognitive and technical abilities which a
cardiovascular intervention requires, a historical volume of no less than
1000 angioplasties and a minimum annual activity of 200 angioplasties. PCI
shall solely be carried out with surgical coverage. If the surgical service is
in another centre, transfer time shall not exceed 60 minutes.
Aortic-coronary by-pass: Each surgeon shall carry out an annual mini
mum of 50 by-passes(1), in a centre where a minimum of 500 major car
diac surgical interventions are carried out by a minimum of three trained
surgeons, a year.
(46)
The average aortic-coronary bypass mortality rates in the USA and the United Kingdom
are under 3%.
65
It shall be noted that the standards of volume of interventions are the
minimum recommended to guarantee patient safety. Other considerations
linked to the efficiency and quality of care, such as maintenance of on call
teams, the adequate use of installations and teams, the relationship between
CCUs activities and the rest of hospital units, etc. tend to elevate this mini
mum volume70. It can be advisable to modify these criteria for reasons of
transport time or accessibility. At the same time, it is advisable to review
quality indicators of centres with less than 250 annual cardiac surgery inter
ventions or 400 angioplasty procedures, and evaluate the options (clinical
managerial instruments; regionalization of healthcare; better selection of
cases for referral to higher level centres; etc.) to correct those centres with
sub-optimum standards.
4.12. Patient implication in his safety
In numerous mentioned safety measures the importance of patient implica
tion in his own safety has been pointed out. The implication of the patient
in his own safety contributes135 to reaching a correct diagnosis; to choose a
healthcare provider; participate in the making of treatments decisions;
lower the rate of medication errors; reduce the rate of infections related to
healthcare; identify inaccuracies in clinical documentation; configure
improvements in design and provision of health services; control and man
age treatments and procedures.
4.13. Self-protection program
The CCUs shares the potential risks of the hospital group. In the documents
of standards and recommendations elaborated by the AC-NHS of the
MSPSI specific self-protection recommendations are contained for different
modalities and healthcare fields.
The hospital with a CCUs will have implanted a self-protection plan,
which will establish the organization of human means and ready material
for the prevention of a fire risk or any other equivalent, as well as to guar
antee the evacuation and immediate intervention, confronted with eventu
al catastrophes, be they internal or external.
The self-protection plan will contain risk evaluation, protection meas
ures, emergency plan and the measures for implantation and actualization.
66
5. Area of the heart: assistance
network, healthcare
processes and regionalization
of services
The cardiology area comprises a series of healthcare units which support
the healthcare to those patients who are grouped around a block of health
care processes, for sharing characteristics referring to form of presentation
of the pathologies they are comprised of, their clinical management and the
resources which their healthcare requires.
The concept of healthcare units responds to organizational and man
agement criteria, and shall fulfil all requirements so that the healthcare
given be of quality, safety and efficiency. Those requirements, especially
those referring to human resources, depend on the complexity of the
healthcare and organization.
The processes have continuity through time, while the units intervene
in the course of the processes, being able to do some of them more than
once and even in continuous form.
The management of the healthcare process shall coordinate the inter
vention of the different units which intervene on each patient.
67
The development of the relationship between healthcare processes
and the CCUs’s, in the present chapter attends to the following sections:
concept of healthcare network; 2. blocks of healthcare processes; 3. region
alization of CCUs services; 4. relationship between processes and their link
to the units of the cardiology area, with some schematic examples of the
most significant processes, through flow diagrams. The last section of this
chapter is dedicated to the structure of management of the CCUs network.
5.1. Assistance network(47)
The ECI-NHS introduces an healthcare network with the objective of
improving the healthcare to the patient with ischemic cardio-pathology and
differentiates an healthcare network for acute coronary syndrome and
chronic ischemic cardio-pathology: Define an healthcare network in an
autonomous community, to attend to acute coronary syndrome and chronic
ischemic cardio-pathology, establishing the low for the healthcare to those
patients. Besides putting into operation forementioned network, la
autonomous community will design a quality monitoring system, which
includes key aspects in relation to the healthcare(48) process.
The ECI-NHS defines the healthcare network as coordinated work,
according to the grade of complexity, of the different levels of healthcare
(healthcare at home, extra-hospital emergency, healthcare in health centres,
hospital emergency, programmed hospital healthcare, reference services
and others) in a determined territory (for example, health area, region, etc.)
to treatdifferent clinical situationsin a continuous manner and in the most
efficient way possible. Understood in this manner, the concept of healthcare
(47)
This section is partly based on the remarks provided by Dr. Ginés Sanz, as well as on the
development of the assistance network concept by the document’s editorial board that is
applied to the CCUs.
(48)
The key aspects in relation to the healthcare process considered by the ECI-SNS are the fol
lowing:
Existence of a patients with acute coronary syndrome classification system, according to seri
ousness and a 12 derivation electro-cardiogram and initial stratification performance, if possi
ble within the first 10 minutes.Time for revascularization with fibrinolitics in less than 30 min
utes (time door-needle) or 90 minutes (time call-needle) or primary angioplasty in less than 90
minutes (time door- bag). Coronarography performance, with a view to revascularization, with
in a period of maximum 3 months from its indication. In case of needing a revascularization,
this will be done through surgical coronary or percutaneous interventions. The coronarography
and revascularization on patients with left ventricle ischemic systolic dysfunction, when it is
considered indicated, will follow the same steps.
68
network is generic Referred to more than one pathology) and involves dif
ferent functional and structural designs according to geographic character
istics (for example, climatic variations, accessibility, being an island, etc.) and
the demography (dispersion) of each community.
And it continues to indicate that in the healthcare network there can
exist one or various clinical ways (or clinical routes), which refer to patients
affected principally with a specific pathology or condition (for example,
ischemic cardio-pathology, cancer). Each clinical pathway is defined by the
group of criteria, indications and counter-indications which guarantee the
opportune and correct treatment of those patients. The clinical pathway is
presented graphically as a decision tree or flow diagram, which specifies the
alternatives according to diagnostic criteria, and times and selection proce
dures are associated.
The change in epidemiological profile which accompanies ageing of
the population (co-morbidity, chronic status, dependence, fragility), the
technological evolution, as well as the development in the United States of
integral systems for health healthcare surrounding business management
(Health Maintenance Organization –HMO-) have provoked a profound
revision of the organization of health and clinical management based on the
healthcare to episodes. The continuity of the healthcare99 and care provision
are central elements for a population with a high proportion of elderly peo
ple, who have a high prevalence of chronic and degenerative diseases (car
diac insufficiency is an example), frequently concurring, whose trajectories
until death are marked by relapses and improvements, and by a progressive
deterioration of their autonomy (dependence) and fragility136,137. The sys
tematic healthcare to those patients who represent approximately 50% of
the present hospital healthcare burden (average in hospital stays; possibly,
costs, represent a major percentage), have shown not only a reduction in
healthcare costs (reduction of admissions and hospital stays, reduction of
the frequency in emergencies, adequate use of medication) rather also an
improvement in life quality and prognosis of these patients4.
The change of management by episode to management through
processes entails the revision of relative organizational and managerial
aspects of health healthcare and in the manner their activity is measured
and evaluated. The Institute of Medicine of the United States has pointed
out the insufficiencies of the present information systems to capture infor
mation relevant to healthcare activity, pointing out among these deficiencies
can be found the majority of the measures which are centred in a deter
mined point of time138, and the National Quality Forum is developing a
measurement system which permits the evaluation of efficiency through the
69
healthcare episode, defined as a series of contiguous health services in the
time related to treatment in a determined period of the illness in answer to
the specific request of the patient or other relevant entity139,(49).
The change from healthcare centred on episodes to another which
guarantees healthcare continuity, implies the overcoming, by clinical servic
es, of strict hospital limits, to integrate themselves in a network articulated
around an healthcare process which guarantees continuous healthcare.cov
ering self-care, the patient’s home, social and social-health resources, pri
mary care and other hospitals of different complexity, acute patients or their
convalescence.
The healthcare network, based on its description and the studies by
Shortell140, hall count on a geographic and population model defined for
each process block; it shall count on a list of resources (home, health centre,
local hospital, reference services, convalescence care, etc.) integrated in the
same and their characteristics; it shall count on instruments, know to and
used by their professional, which guarantee the continuity of care (proto
cols, routes, integrated healthcare processes, etc.). The network shall inte
grate healthcare teams/professionals in functional (especially information
systems) and clinical (management of processes, management of illnesses)
aspects.
The healthcare network shall proportion healthcare with the most
adequate service (home support, doctor’s office, day hospitalization, con
ventional hospitalization, units for medium and lengthy stays, at home hos
pitalization, etc.) guaranteeing quality, continuity and integration of health
care in the most efficient manner.
Integral emergency cardiological system
The integral emergency system is a special type of healthcare network. The
integral emergency system can be defined as a group of coordinate func
tional units, which act in a defined geographic space, to achieve a final objec
tive, which is to reduce mortality in a determined group of processes which
are rendered such as emergencies and lower their after-effects. In the docu
ment of standards and recommendations for hospital emergency unitsthe
development and implantation of an integral emergency system to assist
patients with acute coronary syndrome, ictus and multi-traumatisms is rec
(49)
The definition has relevance to the reimbursement activity system. The publication of the
NQF, accessible on internet, does not allow its quotation.
70
ommended. The implantation of information technologies (ICTs) contributes considerably to the management of those systems141.
The NQF has proposed a group of indicators (National Voluntary
Consensus Standards for Emergency Care – Phase I: Emergency Depart
ment Transfer Performance Measures142 to evaluate quality in the transfer
of patients from a UUH to another hospital. In the same manner, the Col
lege of Emergency Medicine has elaborated a group of indicators which can
serve to evaluate the functioning of the «emergency system». The AHA has
elaborated a group of recommendation to develop healthcare systems for
patients with acute coronary syndrome with elevation of ST143,144,145,146,147,148.
In attachment 2 the structural measure, processes and proposed results by
the AHA are contained to evaluate the emergency system for the health
care to the patient with cute coronary syndrome.
In a revision of strategies developed by hospitals which reduced the
door-balloon time in the acute coronary syndrome with ST elevation, six
strategies demonstrated efficiency150 are identified149:
• That emergency doctors have activated the cardiac intervention unit.
• That a sole call to the coordinating centre activate the cardiac inter
vention unit.
• That the cardiac intervention unit emergency service be activated
while the patient is being transferred to the hospital (the strategy
with the greatest reduction in door-balloon time gotten).
• That a cardiologist on call be physically present.
• That the emergency teams and the cardiac intervention unit use
information in real time.
Spanish experience, such as Galicia (Progaliam)150, Navarra and Mur
cia (Aprimur), show feasible and consolidated regionalization processes of
the IAM systems.
5.2. Block of healthcare processes in the
cardiology area
To the effects of this document a block of healthcare processes is
understood as a group of processes which shares similar characteristic as far
as in the manner of presentation, clinical management, health resources
which are used, etc. Paradigmatic examples of a block of processes are the
IC, the stable angina or the acute coronary syndrome. For all of those large
groups of processes, the SEC and the ESC, as well as the AHA/ACC have
elaborated clinical practice guides151,152,153,154,155,156,157.
71
Besides ischemic (acute or chronic) cardio-pathology and IC, there are
other process groups which make up the large majority of practice in the
CCUs, for which European and American scientific societies have elaborat
ed clinical practice guides: cardiac158; valve disease, congenital cardio
pathology in the adult159; cardiac arrhythmias and circulation160,161 disorders.
In a first approximation, we propose the configuration of blocks of
healthcare processes in the cardiology area for congestive heart failure,
acute ischemic Cardio-pathology, chronic ischemic Cardio-pathology, car
diac valve diseases, ascending aortic pathology, congenital cardio-patholo
gies in adults and cardiac Arrhythmias and circulation disorders.
The correct healthcare to those processes requires the integration of
the CCUs’s in healthcare networks which cover also extra-hospital resources,
such as primary care and emergency system (Chart 5.1.; Figure 5.1.).
Congestive heart failure (CHF)
Systemized attention to the chronic patient, based on the structured rela
tionship between specialized attention in cardiology and primary care in the
corresponding health area and a reference system with resources of a high
er level of complexity, through the regionalization of the CCUs. The region
alization of the CCUs for this block of processes, which is developed in sec
tion 5.5., should take into consideration the designation of reference units
of the SNS(50). In Attachment 3, an adaptation to the patient with congestive
heart failure is proposed to the organization of healthcare to the chronic
complex patient, taken from the document of standards and recommenda
tions for the healthcare to the multi-pathology patient4.
Acute ischemic cardio-pathology
Integral emergency system for thoracic pain, acute coronary syndrome with
or without ST elevation. The emergency system shall be structured to
achieve the objective of carrying out electro-cardiogram and triage in the
briefest space of time possible(51) to identify acute ischemic cardio-patholo
gy in the case of thoracic pain.
(50)
Conditions, techniques, technologies or diagnostic or therapeutic procedures for which it is
necessary to designate RCSU-NHS. Área de cardiología y cirugía cardiaca (Area of Cardiol
ogy and Cardiac Surgery).
(51)
ECI-SNS, figure 3.4. of presentation and clinical assessment of patients; and figure 3.5 of
risk stratification.
72
In the case of acute coronary syndrome with ST elevation, the emer
gency system shall favour the carrying out of primary angioplasty in an
healthcare unit which encompasses optimum quality, safety and efficiency
conditions (ECI-NHS)(52).
Chronic ischemic cardiopathy
The systematic healthcare to this block of processes is similar to cardiac fail
ure, based on the inter-relationship between primary care and specialized
cardiologic healthcare in the frame of the Health Area and a reference sys
tem of resources of a higher level of complexity, through the regionalization
of the CCUs.
Cardiac valve illnesses
The systematic healthcare to this block of processes is superimposed to that
of cardiac failure. The systematic healthcare to this block of processes shall
keep in mind the designation of reference units of the SNS(53).
Ascending aortic pathology
The emergency system for ruptured aortic aneurisms participates has simi
lar characteristics to thoracic pain, which is the normal manner of manifes
tation, access time to an healthcare point where an electro-cardiogram,
imaging (echo, angiograph; CT and RNM when indicated) and emergency
intervention if indicated, deemed critical162.
(52)
The ECI-SNS points out that primary angioplasty as initial treatment for myocardial infar
tion requires the establishment of a network of tertiary hospitals that can perform continuous
angioplasties and of another network for patient transfer from the patient’s residence, primary
healthcare centre or local hospital with skilled staff and external defibrillator. There shall be
agreed protocols of transfers between hospital, reference centres and transfer systems (emer
gency) to avoid unnecessary wait. The emergency integral system for acute coronary syndrome
shall develop the healthcare network, based on regional planning, that includes,where possi
ble, transfer systems to the CCUs in which it is possible to perform a primary angioplasty in
less than 90 minutes (door-balloon).
(53)
ogy and Cardiac Surgery). Agreement of CI-SNS, 10-22-2009. Cirugía reparadora compleja de
la válvula mitral (Complex reconstructive surgery of the mitral valve).
73
Congenital cardio-patholgies in the adult
The systematic healthcare to this block of processes is superimposed to that
of cardiac failure. The regionalization for this block of processes shall keep
in mind the designation of reference units of the SNS(54).
Cardiac arrhythmias and circulation disorders
Arrhythmias and circulation disorders linked to the rest of block of process
es, which participate in the same healthcare network and the emergency sys
tem for syncope and cardio-pulmonary resuscitation. The emergency system
for síncope encompasses similar characteristics to thoracic pain (access to
an healthcare point where an electro-cardiogram and cribbage can be per
formed). The emergency system for cardio-respiratory failure encompasses
also an extra-sanitary field, of immediate(55) action.
(54)
ogy and Cardiac Surgery). Agreement of CI-SNS, 10-22-2009. Integral healthcare in adult with
congenital cardiopathy and family cardiopathy (it includes hypertrophic myocardiopathy).
(55)
RD 365/2009, of 20th March, whereby the minimum conditions and requirements on safety
and quality in the use of automatic and semi automatic external defibrillators are established
outside the medical field.
74
75
5.3. Regionalization
The regionalization of services obeys to criteria for quality assistance assur
ance because there is sufficient scientific evidence about the relationship
between mortality and/or morbidity and volume of hospital and profession
al activity for determined medical and surgical procedures, as has been men
tioned previously. Decisions about regionalization can be justified also from
an efficiency viewpoint, like for example, the number of professionals
required for a continuous healthcare system (24 hours, 365 days a year); or
the number of studies which permit the obtaining of optimum equipment
performance.
The Royal College of Surgeons of England has proposed centralizing
surgical emergency services, with larger population coverage, as well as
being feasible having a reference service for emergencies with operating
rooms dedicated 24 hours a day to emergency operations163.
The quality, safety and efficiency in the use of resources require the
concentration of technology and experience, which is also necessary to guar
antee equality (access to the same quality of services for the same need).
Some services should be centralized and others should be made available in
local hospitals; and even in grounds closer to the patient’s environment. The
relationship between regionalization of specialized healthcare and the
development of hospital resources at a local level are not contradictory
alternatives. The creation of integral healthcare networks shall permit a sup
port to cardiology in local hospitals/health areas of a small population size
from CCUs’s that have a sufficient population field to guarantee quality,
safety and efficiency.Various institutions have established activity volume
requirements for some procedures or activities in the CCUs, related to the
quality, safety and efficiency of the same, which are encompassed in Chart
5.2.
76
77
In Chart 5.3. some criteria for structural resources, based on popula
tion are contained..
The BCS in its -clinical governance review standards- establishes, at
the same time, standards of population for the dimensioning of human
resources and provision of UAAC’s(56).
A guiding approximation to an assistance network of UAAC’s with a
regional basis can be that shown in chart 5.4.(57).
(56)
The Wright and cols criteria. (The Society of Cardiothoracic Surgeons and The British Car
diac Society, 2002) take efficiency elements into account; such as the necessity to maintain an
on-call service «located» as a rotation system of 1 out of 5 days. A number of 6 surgeons and
1.200 major interventions is considered the «minimum viable» for the unit.
(57)
In the chapter size and performance requirements for each unit are developed.
78
79
5.4. Links between blocks of healthcare
processes and CCUs
The following processes have been selected to illustrate the relationship
between block of assistance processes in the cardiology area and units,
incorporating concepts of assistance network and regionalization of servic
es.
Congestive heart failure
Systematic approach to the attention of the patient with congestive heart
failure, based on the assistance model developed by Kaiser Permanente for
the chronic patient, adopted by the Health Department of the United King
dome and adapted to the document of standards for multi-pathology
patients in the National Health System, is developed in Attachment 3. In the
figure a pathway scheme referring to the assistance network between pri
mary care and the ICC unit of the reference hospital is developed. The link
between the cardiologist responsible for the unit and the doctors in primary
care, within a determined geographical and population frame, for the sys
tematic healthcare to the patient with advanced congestive heart failure is
an important characteristic of this network. This link shall avoid, whenever
possible, the healthcare to the patient in hospital emergencies or admission
to the hospital, as well as facilitate hospital discharge. The IHI with the col
laboration of Robert Wood Johnson has published a guide to facilitate the
discharge of the ICC167 patient to his home168.
80
Thoraic Pain / Acute Coronary Syndrome With / Without St Elevationthe Eci-Nhs Incorporates Clini
cal Outlines, Which List Healthcare Services, Units And Objectives. In Attachment 4 Implantation Criteria For A Primary Angioplasty Network, Adapted To The Program
Stent For Life, Promoted By The Esc Is Listed.
81
82
83
84
85
5.5. Managerial structure of the CCUs
network
This document uses the term «unit» to refer to an organizational structure
that is a different entity depending on where the hospital is located, its range
of services and the territorial area (local, health area, regional or reference)
that it covers.
The organizational structure and management of the CCUs, as well as
their aggregation in less differentiated units or their segmentation in more
specialized ones, depend on the organization and management system of
the healthcare service, hospital or entity (public or private) in which they
are. The specific aspects of the organization and management are dealt with
in the corresponding sections of this document. The attributes of an entity
require the creation of a certain structure, so that the aggregation or differ
entiation of units must be based on the most efficient solution in each con
text(58).
In the framework of the creation of the healthcare network and the
regionalization of cardiology medical care, it is considered that:
1. A management structure must be defined and developed for the
CCU network that maintains its own entity independently from
each one of the central area healthcare units integrated into the net
work,. The management structure of the network has to have a man
ager or coordinator (coming from the professional ranks of the
CCUs) as well as somebody in charge of nursing and a member
body in which are represented all the integrated units in the net
work. On occasions, it might be useful to develop wider associations
(neurological, vascular, diagnosis by image, rehabilitation etc.)(59).
2. The organization of the CCU network has to develop protocols of
treatment, integration, coordination and development of the
healthcare network and the discussion of cases with a multidiscipli
nary focus, guaranteeing the quality of healthcare and patient safe
ty.
3. The CCU network must promote continued training of its profes
sionals and the development of activities in teaching, research, inno
vation and development.
(58)
For example: Royal Decree 71/208, of 23rd June, regulating the operation of the Heart Clin
ical Area (BON of 23rd July 2008).
(59)
For instance, if it refers to circulatory system diseases, including the cerebrovascular and
peripheral vascular ones.
86
4. If talking about a management unit of (area, institute, etc.), the
director must have authority over and responsibility for the budget,
appropriate remuneration, answering to management and provid
ing suitable systems of information and administrative support. For
that, it is advisable to appoint someone from other hospital servic
es (economic-financial, personnel, general services etc.) as support
for the management unit, or someone who is incorporated into the
staff.
5. It is worth mentioning the development of the heart failure unit,
along with the support from the CCU, right from the health area
hospital to the local hospital. The links between the person in
charge of cardiology for the heart failure unit and the primary care
doctors, within a geographical and certain population framework,
are essential for the smooth running of this unit. This relation shall
be extended, in geographical spheres and disperse populations, to
the support of «local hospitals» in whose case shall cover not only
the inter-consultation of clinical services (especially in internal
medicine) but also those activities in which it is more efficient to
carry them out «in situ». (Table 5.4).
6. The CCU of regional character (interventionism, electrophysiology,
cardiovascular surgery) must guarantee equal access to healthcare
for all its patients of that geographical and population sphere, with
instruments of management of demand, quality guarantee etc., in
this territorial sphere. Similar systems to those established for the
early return of transferred patients for primary angioplasty to their
home centre, must be implemented in order to avoid unnecessary
stays in the reference hospital.
7. The implantation of the ECI-NHS, and, therefore, the creation of
healthcare networks (integrated emergency systems) for the treat
ment of severe coronary syndrome and the application of guides for
clinical practice, benefit from the development of a management
structure of the healthcare network (that shall incorporate into a
population of around 1.2 million inhabitants)(60) for this block of
processes, with a person in charge (among the professionals who
participate in the integral system) and a committee made up of all
the important units that are involved in the healthcare process.
(60)
The care of acute coronary syndrome would benefit, in those geographical areas where pos
sible, from a concentration of on-call laboratories (24*7*365) where primary angioplasty can
be executed in centres with a population coverage of 1.2 millions inhabitants (PCI) and hav
ing cardiovascular surgery (or would be able to transport it in < 30 minutes).
87
8. Shared hospital records, the use of the ICTs and the transport sys
tem are essential resources towards the development of the health
care network.
5.6. Organization and operating manual
The central area must have an organization and operations manual in which
it must show: the flow chart of the unit; the range of services; the physical
requirements of the unit, its structural resources and equipment; the
processes; the criteria of patient inclusion; the instruments of healthcare
coordination between the units and other services in the healthcare net
work; protocols and guides; lines of responsibility in each of the functions,
and all the considered requirements in the criteria of organization and oper
ations.
The manual, that observes the aforementioned general organizational
requirements, must be open and upgradeable in accordance with the modi
fications that occur within the range of services or with structural or func
tional changes.
The responsibilities, along with the hierarchical lines, powers and abil
ities of each unit member must be defined in the organization chart.
Every member must have information about objectives, staff, manage
ment structure, committees, dress code and discipline, lines of responsibility
and communication, ethical directives, etc. that facilitate the integration and
development of a sense of belonging to the cardiology area.
5.7. Information and communication
technologies (ICT)
In the framework described in chapter 4, with a healthcare network and
regionalization, there must be efficient and continuous communication
between the different resources. Shared health records are an important
instrument for good communication between the different professional
teams, institutions and fields in which the integral treatment of patients with
heart disease is managed.
As well as shared health records, the use of information technologies,
such as cell phones, email and videoconference, must facilitate communica
tion and the exchange of information between the different network nodes
88
and avoids unnecessary travel for patients(61). The CCU must be able to use
these resources in the network with primary care, emergency services and
other specialized units.
The European Society of Cardiology167 notes the necessity to integrate
the different applications that generate important information for the treat
ment of patients with cardiovascular pathology into a Cardiology Intraining
System that allows access to the most important data from any point in the
healthcare network. The use of electronic health records, especially in out
side consulting and the ensuing paperwork168, does not significantly increase
the time for patient treatment but it does improve efficiency and healthcare
quality and diminishes the number of errors169,170.
The Heart Area (and the healthcare network) must have a cardiology
information system based on documentation standards, nomenclature, data
and image exchange that guarantee data availability for the clinic´s decision
making just as for communication with the hospital information system,
obligatory information for the health authorities, data for billing, etc.
One must foresee, within the healthcare network, a definition for
information access, for example, access to patient information from the hos
pital or primary care; and the registration of information related to moni
toring, cardiovascular events, etc. In general, every hospital currently has its
own system of clinic information related to patients in its own care. The
CCU network must create a system to gather and share patient information
that flows freely within the system, available to the centres that make up the
healthcare network.
The aforementioned configuration of electronic health records will
bring in changes in the form of how health staff will treat patients and the
process of access and safeguarding of information. It is possible that it will
be necessary to have an infrastructure (that could exist already in the hos
pital) for the maintenance of information servers, the updating of the hos
pital information system, which shall come under the management of the
CCU network. (5.5) In relation to the development of the ICTs is the pos
sibility of new healthcare models that allow the monitoring of patients with
in specific clinical parameters through equipment installed in their resi
dence, which would transmit information.
The first steps in the residence monitoring have begun with the remote
monitoring of MP, DAI and DA/TRC171. The information of the device can
be sent from the residence in programmed dates or at the moment in which
(61)
In the development of these communications systems, the fulfilment of the confidentiality
and privacy requirements laid down by the Organic Law 15/1999, of 13th December, on Per
sonal Data Protection shall be taken into account.
89
a variation occurs in the pre-determined parameter limits. As well as the
information from the device, it is possible to monitor with the same work
ing methodology other variables that are especially useful in the monitoring
of patients with cardiac deficiencies, weight, blood pressure, intrathoraci
cimpedance, etc. This information can be integrated into the knowledge of
BioMedic data, which is handled by the Congestive Cardiac Deficiency Unit
for the monitoring of patients, therapeutic optimization and early detection
of any clinical deterioration172.
The information system of the Heart Area must consider the necessary
communication protocols to incorporate important resident monitoring
information, passing from «remote monitoring» to «remote patient man
agement». That is to say, allow the parameters to be controlled by different
medical units, with minimal common support to enable early detection of
possible deterioration, malfunctioning of devices or other medical situations
that might require action / intervention from healthcare staff.
5.8. Information system and patient
management
The information system will be integrated into the general hospital system,
attending to the requirements derived from patient management, econom
ic-administrative management and evaluation.The admission and appoint
ments of patients must be integrated into the admissions service and central
appointments of the hospital. Patient identification must be error-free and
it is recommendable to have a policy of one means of identification.
The manual input of data must be avoided and the incorporation of
data by means of work lists issued by the hospital information system.
When a consultation is asked for (for example, by the primary care
doctor), ideally by means of electronic appointment, the doctor must state
the reason why he is asking for it along with some medical data of interest.
It is recommendable to structure the reasons for the request. The data for
the identification of patients must be stated in the registry of treated
patients, the date in which they were treated, the studies that were carried
out in the unit and the name of the doctor who carried out them out.
Local criteria must be used in the management of waiting lists. The
introduction of criteria for waiting lists by medical processes instead of tech
nical or procedural processes. All the reports that are created will be turned
over to the hospital network and assigned to the patient records. Organiza
tional and technical measures will be adopted to ensure security, confiden-
90
tiality and integrity of patient data, their right to access, change and foreseen
cancellation in the LO of 13 December, and data protection of a personal
nature. Every patient has the right to confidentiality over their health status
in the terms set out in the regulatory Law of patient autonomy, rights and
obligations in the matter of information and medical documentation. In the
specific case of the management of information created outside the hospi
tal, it is essential to get, in a specific document, patient consent to have their
information made available on the internet or mobile telephone.
The transfer of important data to the patient requires their express
consent, with a few exceptions laid out in the current healthcare legislation.
The information system must allow for the periodic making of an instru
ment panel that examines the monitoring of each unit and the network and
includes an account of results.
It is important that the information system for the Heart Area contains
a module on management of staff assigned to the network, including resi
dents, scholars, personal investigators etc.
91
6. Clinical resources and
non-invasive techniques
The CCU treat patients with cardiological health problems participating
transversely in the healthcare process consecutively or simultaneously (like
the image units, interventionism etc.), whilst maintaining a coherency bet
ween them in diagnosis, therapeutics and care during all the process until
the problem´s solution.
These resources or units do not refer only to specific units of diagno
sis and treatment, (diagnosis and treatment by image, hemodynamics, car
diovascular interventionism, electrophysiology, heart surgery) –object of
analysis in chapters 7-10– but also in clinic resources of a multipurpose and
multidisciplinary nature (outpatients consultations, emergency, conventio
nal hospitalization, intensive care, day hospital, surgical section) whose cha
racteristics have been dealt with in other technical documents of that same
collection. In this chapter, we will make a quick review of these units making
reference to those specificities that apply to the heart area.
Whoever calls these multipurpose resources does not mean to say that
they do not deal specifically with the CCUs, as a significant percentage of
healthcare activity of these units frequently requires –for the volume and
staff training– that consultations, hospitalization units, etc., are specifically
dedicated to the CCUs. Also in this chapter are included non-invasive sur
geries (apart from those of image) that together with echocardiography
usually make up a significant part of its activity as support to other health
care units of primary and specialized care.
There are no added data, referring to the field of NHS that allow an
estimate backed up by outpatient activity and non-invasive techniques. An
estimate of annual attendance for one thousand people, based on a sample
of several NHS hospitals, might be in rounded up figures: 20 first consulta
tions; 30 echocardiographies; 5-10 ergometries; 1-2 echocardiographies of
effort; and 5 Holter.
6.1. Multipurpose clinical resources
Outpatient consultation
No added data exist for the NHS group with regard to requests for external
consultation visits of cardiology, nor in connection with initial and follow-up
93
consultations. An estimated attendance in a sample of various NHS hospi
tals with a population and reference scope (local, health and regional area)
might be 20 initial consultations per 1 000 inhabitants a year, with a ratio of
1.5 follow-up consultations per initial visit.
These rates can be conditioned by local variables such as population
structure, incidence variations and prevalence of cardio-pathologies, organ
ization and clinic management characteristics of the cardio-logic patient and
the field of the reference hospital. The ratio between the initial and follow
up visits may drop below 1 when you take into account primary care work
on patient management with chronic illnesses (insufficient cardiac congesti
ve, stable angina for example). Alternatives exist for outpatient healthcare,
whose suitability relies on the local healthcare culture and ultimately the
relationships between the players involved in the process.
As a general rule, it is necessary to develop tending strategies to
modify the perception of outpatient consultation as a minor task, with a
view to achieving efficient management, promoting a global image of the
healthcare process, from its beginning right through to its completion, whilst
reducing the dependency of patients of a specialized level.Within the
healthcare philosophy suggested by the heart failure unit, the high-per
formance or high-resolution consultation is assigned to the solution of the
problem that might be carried out in an outpatient form: healthcare for the
clinically unstable patient; diagnostic studies of rapid resolution, monitoring
of very early or frequent check-ups of patients with active illnesses to deci
de on their admission.The high performance consultation must be used as a
resource more within the management of chronic complex patients.
Other forms of interrelation and joint work between primary health
care and the CCUs as a go-between (via telephone or email), or clinical ses
sions etc., must be implemented. Purely bureaucratic diversions, like making
appointments to fix examinations, giving out forms or filling in prescriptions
and having check-ups in a stable stage, must be avoided. In section 5.4 and
Annex 3, the unit for insufficient cardiac congestive, for example, is referred
to, based on the organization of systematic healthcare between primary care
and specialized cardiological healthcare for patients with this pathology.
This scheme of operations can be extended to clinical management of com
plex patients with chronic heart disease.
The administrative structure of the unit must be focused on the
patient, facilitating access to the unit and simplifying administrative forma
lities.
94
Day-care Hospital (DCH)
The day-care hospital can correspond to the typology of DCH multi-pur
pose doctor (autonomous unit that makes its resources available to other
hospital services including the CCUs) or be integrated into the heart failu
re unit, equipped with various positions answering to the person in charge,
situated in the same environment as the consultation.The surgery of cardiac
interventionism (hemodynamics, electrophysiology and some examinations
like stress tests, heart ultrasound, scans must have at its disposal people
working in day-care treatment that allow the recovery of patients and their
discharge to be given in their residence or local centre the same day as their
examination. The place of day-care treatment associated with surgeries and
treated by nursing staff linked to those same surgeries, does not comprise a
different healthcare unit, in the way it is defined in the document on day
care treatment.
Hospital emergencies
The relation between the CCUs and the emergency ward service is modified
with the development of an integral emergency system and a model of syste
matic care to chronic complex patients, reducing the delay of care and the
unnecessary demand for emergency services by consequence or spontane
ous access of the patient. (Annex 3)The development of an integral system
of emergency services (for example, for the care of severe coronary syndro
me with ST elevation) needs protocols from the CCUs and the heart failu
re unit for fast track procedures that avoid delays, which might harm the
patient, in the emergency services unit.
Conventional hospitalization
Conventional hospitalisation occurs within a nursing unit of multipurpose
hospitalisation of chronic patients (INU) (UEH in Spanish) that is defined
asan organization of healthcare professionals who offer multidisciplinary
healthcare in a specific area of the hospital, that guarantees the care of hos
pitalised patients, doctor or surgeon, severe or chronic patients made more
acute who do not require advanced or basic respiratory support nor support
one or more organs or systems and fulfil some functional, structural and
organizational requirements and guarantees appropriate quality, safety and
efficiency conditions. The hospitalisation unit is like an intermediary unit
95
that offers services (principally nurse care and catering) to the patient (diag
nosis and / or treatment) being treated by clinic services, generally doctors
or surgeons, and for whose proper running requires the integration and
coordination with the greater part of the hospital units. The service exten
ded to critical care should be developed, which will ensure the continuity of
healthcare through collaboration between the critical care service and the
nursing unit of multipurpose hospitalisation of chronic patients.
The INU must guarantee the admitted patient:
– The assignment, introduction and identification of the doctor res
ponsible for the patient’s care.
– All the patients with IAM or acute coronary syndrome shall be tre
ated by a cardiologist.
– Assignment, presentation and identification of the nurse responsible
for the patient’s care each time.
– Initial evaluation of the nurse and registration of vital signs in the
moment of admission.
– Monitoring plan that specifies the signs and parameters that must be
registered and their frequency. The use of a system of monitoring
physiological constants and activation (track and trigger systems)
should be used that systematise the check-up of patients in the INU.
– Medical evaluation, information (in this case, informed consent),
requests for additional examinations and treatment prescription, if
required.
– The carrying out of nursing activities, such as the comprehensive
assessment of health problems, data collection, the establishment of
care plans and the development of their own intervention and dele
gation.
Effective communication must be promoted between professionals
involved in patient care by means of the implementation of a formalised
system of an exchange of information, especially in shift changes, the
moving of patients between units and discharge.The daily practice of pas
sing visits is recommended as a means of quality, safety and efficiency of
healthcare in the INU, which includes Saturdays, Sundays and public holi
days, avoiding in this manner stays in the INU of patients who might other
wise have been discharged provided that the healthcare process meets pro
tocol requirements through the established clinic.
The multidisciplinary passing visit must form part of the healthcare
routine, which means an agreement between professionals must be reached.
It is recommended that each daily visit should have at least the doctor and
nurse in charge of care for that patient. The passing visit should take place
first thing in the morning, which allows discharges to be dealt with when
96
more demand for admission comes from the emergency ward.The process
of discharges should be planned and unnecessary stays should be avoided.
The duration of each stay must be adjusted to the necessary time, sup
porting the discharge in resources linked to the healthcare network (pri
mary healthcare, residential healthcare, high resolution consultation, day
care treatment and convalescence units).
The quality of care given to patients who have been admitted is high.
The use of monitoring systems continues in the patients’ room with a cen
tral station under the nurse check-up, which can be classified as level 1 of
critical care, as laid out in the Intensive Care Society in the UK173 or, using
the Spanish terminology becoming more and more common, «intermediate
care»174.
In this type of INU the ratio between patients and nursing staff must
be fewer than normal, allowing for around 6 to 8 patient per nursing team
(a nurse and an aide) for day shifts and 12 to 13 patients for night shifts. The
specifics in the management of this type of patient makes it advisable that a
sufficient healthcare demand can always be guaranteed – hospitals with a
population scope of Health Area or superior hospitals – offer nursing units
for the care of cardiological patients. The nurse in charge of the unit of hos
pitalisation must be trained in cardiology. The cardiological ratio per admit
ted patient of 1:10 or 12 may be reasonable(62).
From the organizational perspective there are basically two alternati
ves (non exclusive) with regard to the management of bed resources on the
part of the UACC. Possibly the most classic example is offering clinic pro
fessionals to the healthcare of admitted cardiological patients. In the pro
posed organization for the «multi-pathology patient unit», adapted for the
heart failure unit (Appendix 3), each cardiologist manages assigned beds to
treat patients coming from a specific population sphere (with necessary fle
xibility to adjust to variations of demand). This management method of the
beds could be extended to interventionism (hemodynamic, electrophysio
logy) and, obviously, to cardiovascular surgery, which would probably allow
a better identification of the patient by the doctor in charge, as well as a
more efficient management of the beds.
(62)
The residents of 4th and 5th year would stand for 50% of full-time. The ratio 1:10 has been
calculated for an average stay of 5 days, in case of a longer stay it will tend to 1:12.
97
Intensive / Critical care
For which the decision to specialize a unit of intensive / critical care for car
diovascular patients depends on the activity. This unit should have between
six and twelve beds.
The terminology of Cardiological Critical Care Units must be brought
to the attention of cardiovascular patients.
The unit, as general as it is specific, must comply with standards and
recommendations for type of unit10, among which are:
– A director of the critical care unit and someone in charge physically
24 hours per day.Someone from nursing in charge of coordination
between nursing professionals assigned to the critical care unit.
– Explicit criteria for the admission and discharge of patients.
– The protocoling of medical and nursing activity of processes and
procedures most frequently carried out in the unit.
– Respect of patient rights and the compliance of safety standards,
with protocols for their systematic compliance.
– The assignment of a nurse in charge of patient care, by shift. The
patient / nurse ratio depends on the mix of complexity of the
patients being cared for in the unit.
– The existence of a formalised system of exchange of information
between staff involved in the care of every patient during shift chan
ges as well discharging patients to other units.
– The existence of a formalised system of joint doctor / nurse passing
visits who are in charge of patient care that might include other pro
fessionals (dieticians, pharmacists, specialist consultants, social wor
kers, physiotherapists).
– Support services that guarantee quality and continuity of care.
The BCS establish standards for the Coronary Care Unit which figure
in table 6.1.
98
The alternative that is recommended in this document is, so long as the
healthcare volume allows it, to create a unit for cardiovascular patients in
levels of care 2 and 3, caring for the patient in levels 0 and 1 in the conven
tional hospitalisation multi-purpose ward with specificities described for the
rooms and nurse check-up for level 2 (intermediate care).
99
Picture 6.1. Cardiological critical care unit: patient
Picture 6.2. Cardiological critical care unit:
cardiovascular nurse station
Picture 6.3. Critical care unit:
patient box
Surgical unit
The operating theatres or surgical sessions dedicated to cardiovascular sur
gery will depend on the volume of cases dealt with and share the same cha-
100
racteristics, in so far as their standards and recommendations, that the gene
ral surgical block in which they are included, should take into consideration
the following aspects(63):
• The cardiac surgery operating theatre must be next to the CCU and
the interventionism ward to allow easy access from the hospitalisa
tion unit and have a good connection with the sterilisation service.
• The cardiac surgery operating theatre requires a slightly bigger size
than the general surgery operating theatre. It must have a minimum
area of 63m2, basically rectangular, with a length of the smaller side
above 7m.
• The lighting of the surgical room must allow simultaneous work to
be carried out in different areas. The surgical table must be adapted
by technical experts in imaging, with a capacity to send / recover
scan studies to / from the Hospital’s Information System -PACS
(picture archiving and communication systems). It is best if there is
interaction with the experts in intraoperative scans when necessary.
• The operating theatre must have various information terminals con
nected to the hospital network with regulated access to clinical
patient information for the use of surgeons, nursing staff, anaesthe
tists and perfusion.
• There must be a preparation room adjacent to the cardiac surgery
operating theatre for the cleaning of the machine (three machines
for every two operating theatres).
• The room must have a computer terminal to access patient history
and the work surfaces with sufficient height to store wheel chairs as
well as wardrobes and shelves.
• The perfusion machines, counterpulsation cylinders and other
equipment must be stored in this room when not in use.
• The extracorporeal storeroom, adjacent to the extracorporeal pre
paration room It must be big enough to allow the storing of large
quantities of material for only one usage and fluids. The restocking
of equipment and routine maintenance must be carried out in this
room. The ratio of operating theatres and post-anaesthetic recovery
posts must be one to one, less than what is recommended for gene
ral surgery, but a greater proportion of patients will be directly
admitted to the UCI.
(63)
Adapted from: Health Building Note 28. Facilities for cardiac services. DH States and Faci
lities Division. 2006.
101
• The equipment storeroom. For the storing of infusion bombs, scans
and portable equipment for radiodiagnosis. The electrical recharging
of equipment must be possible. There must be shelves with separate
access to electrical sockets.
• Every operating theatre must be equipped with two columns.The
operating theatre must have oxygen, nitrous oxide, medical and sur
gical compressed air inlets, vacuums and extraction of anaesthetic
gases.
• The operating theatre must have a small space for a counter to exa
mine parts.An operating must have at least one colour closed circuit
television incorporated into the operating theatre light and linked to
a meeting room, for teaching.
• An exit zone for every pair of operating theatres to put beds (23m2
to put beds). This zone must contain a local storeroom.
Table 6.2 shows the BCS standards with regard to interfacing between
cardiology and cardiovascular surgery.
102
Rehabilitation
The guides of clinical practice for the prevention of cardiovascular disease
published in 2007 by the ESC indicate the necessary contribution of gene
ral medicine and cardiovascular nursing in the prevention and treatment of
cardiovascular diseases in Europe 175. The actions of nursing staff in the pre
vention and cardiac rehabilitation range from health promotion, manage
ment of chronic illnesses to the development of care. The program of pre
vention and cardiac rehabilitation must be organized into a multidiscipli
nary team in which participates the cardiologist, the rehabilitating doctor
and primary care doctor, the nursing staff of specialized and primary care,
the physiotherapist, the dietician, the psychologist and the social worker.
The American Society of Prevention and Cardiac Rehabilitation recom
mends that the nursing professional in cardiac rehabilitation should have one
or two years of experience in care of cardiac patients and with basic kno
wledge of anatomy, physiology and cardiological physiopathology and of bre
athing apparatus, techniques of physical, cardiovascular and lung evaluation,
clinical electrocardiography and recognition of arrhythmia, cardiovascular
pharmacology, interventionist methods, physiology of exercise in a healthy,
cardiac subject, adaptations for acute and chronic patients to exercise, strati
fication of risk, stress test, prescription of exercise, criteria for suspension of
physical exercise, basic and advanced cardiopulmonary reanimation, strate
gies for the modification of risk factors and understanding of psychological
alterations in the cardiac patient. The nursing staff in cardiac rehabilitation
must also have skill in the use of material and didactic resources for the modi
fication of risk factors and change of lifestyle, skill and availability to work in
a group with other members of the rehabilitation team, good personal health
habits, enthusiastic and professional attitude. The intervention of liaison and
primary care nursing staff are key elements to ensure the continuity of care
after the hospital discharge.The education of the patient is a right and a social
demand that must be offered by the health system and its professionals as
well as by the resources of the local community. The educative process aimed
at a change of risk behaviour of individuals as well as the groups and surroun
ding communities can be converted into a powerful instrument for change,
not being able to prevent or cure an illness of a stable form without any type
of informative and / or educational activity. The educative process needs con
tinuity. Isolated actions can be useful to raise awareness or inform about some
aspect or specific measure but the development of attitudes, habits and skills
or the real assimilation of definite information requires direct, stable and con
tinued educational intervention.
In Annex 5 there is an outline of the stages of cardiac rehabilitation.
103
Picture 6.4. Cardiac rehabilitation ward.
Picture 6.5. Cardiac rehabilitation
ward (detail)
Picture 6.6. Consultation of cardiac rehabilitation
104
Non-invasive explorations
The structural design of the healthcare network depends on structural and
temporary factors that do not have general solutions. It is recommended,
whenever possible, to physically specify knowledge resources and common
equipment in the diagnosis of cardiological processes (stress tests, image)
and establish agenda logistics that facilitate the strategy of one act that not
only increases the efficiency of the units and patient comfort but also facili
tates interaction between the resources.The department of non-invasive
explorations, including echocardiography, must be located in the area of
external consultations of cardiology, which facilitates the development of
high resolution consultations. The booth must be located adjacent to the
stall for stress tests and scans.
The patient must get changed before the stress test or echocardiography,
in the outpatient area, so there must be changing rooms for patients and a sto
reroom for used and clean white coats, as well as a toilet and shower.
There are no data of attendance added to the NHS group for non-inva
sive explorations: electrocardiogram (ECG), stress tests and Holter tests.
The estimation of the annual rate of use of these tests, with important reser
ves, is around 100 ECG, 5-10 stress tests and 5 Holter tests for every one
thousand people.
Probably significant variations exist in the indications of their use.
Strategies of systematic data gathering should be implemented in informa
tion systems that allow an appropriate management and quality control of
the activity (CMBD outpatients).
Electrocardiography (ECG)
The ECG must be considered as a basic test for many patients. The current
digitalisation of the registries facilitates the strategy of centralised local
positions for the registry of technology (for example in the areas of analyti
cal extraction) that allow the general patient to be referred to strictly the
cardiological healthcare circuit and get this type of systematic tasks to spe
cialised unit staff.
There must be quality ECG equipment in the unit. Every stall must be
able to accommodate the patient, whether in a wheel chair or on a stretcher,
and their companion, to the aide who carries out the ECG and occasionally
a cardiologist.
The stall must have space for electrocardiographic equipment moun
ted on a trolley. The stall must also have an adjustable seat that allows access
105
to all sides and a computer terminal for the aide. The premises and place
(stretcher) where the ECG is carried out must be comfortable and a suita
ble temperature that mitigate the devices for muscle potentials.
There must be a connection and integration of the equipment with the
information system that allows the registry archive, with the univocal iden
tification, date and true time and regulated access to any clinical post.
Stress test176
The box for stress tests shall be wide enough to accommodate the necessary
equipment, including emergency and defibrillator equipment. Each box
shall accommodate the patient and the person accompanying him, the nur
se’s aide and the nurse who is doing the test and occasionally the cardiolo
gist and shall permit the circulation and access to the patient in emergency
situations. The rate of grave complications (heart failure or any grave com
plication which required the admission to the hospital) is esteemed at
1/10.000 tests. Room shall be set aside for electrocardiograph equipment
mounted on a cart, a treadmill or exercise bicycle which permits access to all
sides, a sphygmomanometer, a computer terminal for the aide and shelves
with pharmacological stress drugs.
The box shall have good lighting and be well ventilated, with a tempe
rature (20-22ºC) and humidity (around 50%) control. It is very useful to
have a wall clock with second hand or a digital one. The examination area
shall have enough space for towels, a bucket and other elements needed for
the preparation and test. A curtain for the patient’s privacy during the pre
paration is useful. To evaluate the level a stress to be applied, a perceived
stress scale shall be placed on the wall and in view of the patient. In labora
tories where gas exchanges are performed there shall also be a thermome
ter, a barometer and a hygrometer.
A system for electrocardiograph registration for continuous monito
ring of the cardiac rhythm and evaluation of ischemic electrocardiograph
changes during the exercise shall be set up. The equipment varies from com
puterized to conventional systems.The monitoring of arterial pressure. The
manual taking of arterial pressure is still the most practical and simple
method for the control of arterial pressure. Cuffs of various sizes, including
large and paediatric, shall be on hand. Mercury manometers have been
replaced with digital or aneroid ones for environmental safety reasons. To
carry out an ergometry test a treadmill or bicycle are used. It shall be elec
trical and allow more than 157.5 Kg. The treadmill shall move electrically
and permit weights of 157.5 Kg. It shall have a range of speeds from 2 K/hr
to, at least, 12 k/hr, and with a inclination which varies from 0 to 20%.
106
The treadmill platform shall be al least 130 cm. long and 42 cm. wide.
For patient stability and safety a front quilted rail as well as at least one side
rail is recommended. An emergency stop button shall be easily visible and
accessible for the patient and personnel whenever necessary. Electric bicy
cles are a standard when used for stress tests. They shall include the capacity
to adjust the stress level through regulated manual or automatic increases.
It shall have a handlebar and a seat which can be regulated in height.
The patient with a in-capacity to his inferior members can use arm
ergometers.Equipment for the analysis of gas exchanges. Present compute
rized metabolic systems make possible the collection of exhaled air without
excessive technical difficulty. The use of the analysis of exhaled air impro
ved considerably precision and reproduction to evaluate pulmonary func
tion compared to the indirect stimulation of oxygen captured from work
level.
The collection of arterial samples permits the direct measurement of
SaO2, PaCO2, pH, and lactate, as well as the estimation of the ventilation
blind space when exhaled air is analyzed. The pulso-meter measurement
(Sp=2) permits a quite precision estimation of the SaO2, reducing the neces
sity of arterial blood analysis in patients with pulmonary illness with a stress
test to evaluate respiratory difficulty during exercise.
The echocardiograph and nuclear stress imaging improves the sensiti
vity and the specification of the stress test in patients who are suspected of
having myocardial ischemia and permits the visualization ventricular func
tion. The use of this equipment increases the space needs in the exploration
box. If a gramma-camera is used, the directives for radioactive safety shall
be followed.
There are non-invasive systems which estimate cardiac consumption at
rest and during exercise. They are generally used for investigation, but their
diagnostic precision and prognostic use, as well as the determination of in
which type of patients they can turn out to be more useful, require more
information.
The Stress test can be done by adequately trained personnel who are
not doctors (nurses or technicians), working under the direct supervision of
a doctor, who shall be located in the immediate vicinity.
The professional competencies of personnel who make up an ergome
tric laboratory are published in various guides177. All laboratory personnel
shall have received cardio-pulmonary resuscitation training. The doctor is
responsible for interpreting data. If the results of the test are considerable
abnormal the doctor shall be advised immediately.
107
Holter and ambulatory monitoring of arterial
pressure (Mapa)
The SEC guide for ambulatory monitoring of electro-cardiograms and arte
rial pressure178, recommends its provision, with regionalization criteria refe
rred to in section 5.3.
The MAPA room shall be located within the area of non-invasive gra
phic registers of the cardiology service or, if existing, the heart and hyper
tension unit.
An alternative to this provision is to allocate a centralized room which
offers service to all specialties which use this test.
There are not requirements for Holter and ambulatory arterial pres
sure monitoring, except when a chair of adjustable height and room for the
storing of equipment is available.
In the regional field, with a population estimated to be over one
million inhabitants, the Holter shall be included in the arrhythmia unit with
diagnostic and therapeutic electrophysiology Holter and on some occasions
the pacemaker and defibrillator unit.
The person responsible for the unit shall be a hired cardiologist who is
an expert in arrhythmias and electro-physiological studies. This unit shall
have another doctor on staff available and resident cardiology doctors who
rotate in it. A nurse who is expert in arrhythmias and a nurse’s aide are
necessary. The work of the auxiliary personnel consists of placing the recor
ders on the patients and help in the reading by the analyzer.
It shall have two rooms, located in the cardiology service, one for Hol
ter implantation on the patient and another with the computerized system
for reading the tapes. A regional hospital will need 16 Holter recorders and
one analyzer.
In this type of centre there shall be an implantable Holter, indicated in
patients with recurring syncope, lasting about 14 months.In the health area
hospital, with a population estimated at 250.000 inhabitants, the computeri
zed analysis service of MAPA, shall have six automatic monitoring recor
ders, two of which with a system for ambulatory calculation of transit wave
speed and another combined Holter to cover the needs of the health area.
If that area hospital has an implant/replacement and follow-up of
pacemakers a subcutaneous holter implant can be contemplated. In the case
of the Holter, six Holter registers and one analyzer are necessary. The neces
sary personnel for this activity are a part-time cardiologist and a full-time
nurse.
The local hospital, with an estimated population of less than 100.000
inhabitants, would need two Holter registers and an analyzer wouldn’t be
108
needed, since the tapes could be remitted to the reference for their analysis.
The personnel needed for this activity are a cardiologist and a nurse, both
part-time.
109
7. Diagnosis through imaging(64),
179,180,181,182,183,184,185,186,187,188,189,190,191,192,193,194,
195,196,197,198,199,200,201,202,203,204,205,206,207,208
The field of cardiovascular imaging has experimented an enormous increase
in the last few years. An increase of 26% in the number of studies carried
out in the last 15 years is estimated. New tools have been developed, includ
ing the tri-dimensional, trans-thoracic and echo-cardiograph, the contrast
echo-cardiograph, the tissue Doppler and the techniques of myocardial
detraining.
There aren’t aggregated data concerning the whole of the NHS in rela
tion to the rate imaging technique use. The estimation based on a sample
from various NHS hospitals with fields of population and reference can be
of 40 echo-cardiographs per 1.000 inhabitants and year; the stress echo, can
be situated in a 10-15% of the total and at 5% the trans-oesophagus echo.
These rates can be conditioned by local variables such as population struc
ture, incidence variations and prevalence of cardio-pathologies, organiza
tion and clinic management characteristics of the cardio-logic patient and
the field of the reference hospital.
The cardiac magnetic resonance (Cardio MR) and the computerized
multi-cut axial tomography (Cardio CT) are emerging techniques which
have proven their clinical use, in parallel to the development of the echocar
diograph and nuclear cardiology (Nuclear Cardio). These advances have
given way to a new scenery in which the echocardiograph has gone on to de
named cardiovascular Imagery Unit, has modified its organization, the
training of specialists and the development of four diagnostic modalities.
It is classically established that cardiologists carry out echocardio
graphs in the UAC; the relationship with nuclear doctors has also been
established from years ago. However, the collaboration between radiolo
gists and cardiologists in the studies of cardio MR and CT has not been well
defined as it shall. The agreement between the SEC and the Spanish Soci
ety of Medical Radiology makes up a considerable advance in the estab
lishment of ways of collaboration (Attachment 6).
(64)
This charpter is based on the contributions, made for this documents on standards and rec
ommendations, by Eva Laraudogoitia Zaldumbide, Miguel Ángel García- Fernández, José
Juan Gómez de Diego and Río Aguilar Torres, as well as comments and suggestions by the
Spanish Society of Medical Radiology (SERAM) and PHILIPS and Siemmens. (companies).
111
According to training programs, cardiologists are experts in cardiac
physiology and physiopathology and are very familiarized with cardiac and
coronary artery images. On their part, radiology specialists command the
technical aspects of the MR and the CR and their side-effects. The collabo
ration between cardiologist and radiologists in the interpretation of tests is
considered to be the key to obtaining a maximum diagnostic performance.
Ideally, the study of algorithms, the carrying out of studies and reports shall
be done according to the standards defined by nuclear doctors, radiologist
and cardiologists together.
The principal source of radiation to which the population is exposed
can be derived from the use of radiation ionization for medical examina
tions. The European regulation (EURATON Directive 97/43) and the ref
erence guides for imaging techniques that use ionizing radiation lay down
that the indication and execution of diagnostic procedures using ionizing
radiation shall follow the following basic principles: a justified use (if expo
sure to radiation cannot be justified, it shall be forbidden); optimized (all
radiation doses due to medical studies shall be as low as possible so as to get
the result); and responsible (the prescribing doctor and the doctor doing the
test are responsible for the justification of the patient’s exposure to ionizing
radiation).
The EURATON directive points out that a technique shall be used
that does not use ionization radiation when the information it gives is com
parable to that which a technique that uses radiation does.From this med
ical, socio-economic and individual biological and environmental impact
perspective it is imperative to improve the appropriate use of technology
for the individual and society’s welfare in general.Due to the rapid expan
sion of echocardiograph applications, it is still the most frequently used
imaging technique in a clinic and the basis of the cardiovascular imaging
Unit. The granting of human and technological resources is frequently insuf
ficient, despite the effort which has been made in the majority of the health
centres in our country.
The European Association of Echocardiography (EAE) made up a
committee to establish recommendations and directives for the regulation
of diagnostic indications and performance of echocardiography studies,
their minimum content, the collectionof data (images, and measures), digi
tal storaging, and the drafting of reports. Other societies like the American
Society of Echocardiographs, have elaborated similar documents and also
recommendations for the appropriate use of the technique.
112
Each unit shall define its offer of services, that is to say, the offer of imaging
services which are performed in it, according to healthcare needs in its area
of influence, healthcare demands which have been identified, of technolog
ical resources on hand, of organizational and managerial characteristic and
the experience of its professionals.
Given the important differences which exist between different centres
as far as their size, their area of influence and their technological availabili
ty, the offer of services can reach from only echocardiographs to offering all
present techniques used:
– Trans-thoracic echocardiograph.
– Trans-oesophagus echocardiograph.
– 3-D echocardiograph.
– Stress echocardiograph.
– Contrast echocardiograph.
– PET (Positron Emission Tomography) of myocardial perfusionPET
of myocardial metabolism.
– SPECT (Single Photon Emission Computed Tomography) of myo
cardiac perfusion (201TI or 99mTC. (tetrofosmina or metoxi-isobu
til-isonitrilo)Isotopic ventricularography in equilibrium.
– Gammagraph of myocardial damage (Pirolosfatos of 99mTC).
– Gammagraph of myocardial innervation (123l-meta-yodo-benzil
guanidina).
– Cardio MR for the study of cardiac anatomy.
– Cardio MR for the study of cardiac function.
– Cardio MR for the study of myocardial viability.
– Cardio MR for the study of ischemia.
– Cardio CT for the study of coronary arteries.
– Cardio CT for the study of pulmonary veins.
– Cardio CT for the study of the aorta.
The imaging unit of the cardiology area shall have a person responsi
ble(65), doctor specialist in cardiology, with a specialized level (level III) in
echocardiography. It is preferable that he have preparation in cardio
Nuclear techniques, cardio MR and cardio CT. The functions of the person
responsible for the unit are:
(65)
Depending on the services portfolio of the coronary area (population range).
113
– Organize the whole of the health professionals in a protocol and
consensus framework among them all, with the adequate use of
assigned resources.
– To program the unit adapting the demand to the assigned resources.
– The coordination of the cardiology area for the elaboration of a
group of protocol studies.
– To control the quality of the cardiac image.
At all times it shall be publicly known who the person responsible is
or, if the case may be, the person delegated, so this aspect shall be contem
plated in the functioning norms of the unit.
7.2. The echocardiographic office
According to the White book of Echocardiography in Spain, published by
the Echocardiography Section of the Spanish Society of cardiology in 1996,
it is proposed to name echocardiography laboratory or office to the area
which brings together the qualified personnel and necessary equipment to
perform the echocardiograph diagnostic techniques, integrated organic and
functionally in the CCUs’s.
A homogeneous definition of healthcare levels (regionalization) is not
defined in relation to the development of NHS resources, due to the patri
monial dependency of the same, among other factors. Besides this, the nec
essary time for the performance of an echocardiogram depends on the diag
nostic complexity and not the gravity of the pathology. Therefore, a rela
tionship between the level or type of healthcare (reference hospital as
opposed to those of inferior level, or ambulatory as opposed to hospital
healthcare) does not exist in the design of the echocardiography office, its
provision and minimum requirements.
In this manner, an office in a basic hospital or one which attend sole
ly to ambulatory patients could be in condition to perform any type of study
and develop investigative activities.
The echocardiogram office shall have available the adequate space
and installations to be able to perform complete studies in their different
modalities and shall guarantee the safety of the patient and the personnel
who work in it.
A flexible design is recommended for the office which permits its
adaptation to innovations, due to the rapid evolution of technology and the
clinical application of the echocardiograph. Exterior communication shall
be made adequate to receive ambulatory in and out patients. Accesses shall
114
be designed keeping in mind the variable size of present and future teams.
The design shall take into account the execution of other non invasive car
diac diagnostic activities (ergometry room, pacemaker consultations, etc.)
with the aim of sharing resources (waiting and staff rooms, etc.).
It is desirable that the design of the reception area for administrative
tasks and which prevents interferences with healthcare work. The waiting
room shall be adequately sized with respect to activity and count on acces
sible rest-rooms for patients and those accompanying them. There shall be
a recuperation-waiting area for the hospitalized and/or in bed patient, which
permits observation and care (fixed or portable oxygen source, the taking of
arterial pressure).
The echocardiography stand is the physical space with instrumental,
auxiliary and support provisions needed to perform echocardiography stud
ies. The light shall be soft, to permit good visualization of screens. Patient
exploration shall be carried out in s separate room, destined exclusively to
this type of study, with sufficient space and access for a hospital bed, the
ultrasound equipment and exploration gurney, guaranteeing adequate work
and safety conditions.
The stress echocardiography can be carried out with stress (treadmills
for marching or bicycles) or through pharmacological stress. The different
modalities of stress have as an objective to induce regional movement
abnormalities of the wall which are produced with myocardial ischemia. The
tests differ with respect to patient preparation, protocols and equipment.
A space shall be provided for storage of medication and fungible med
ical material and for the reanimation equipment, in the case that the office
isn’t shared (with ergometry) and trans-oesophagus and /or stress echo-car
diographs are performed.
An independent work area with space to perform an analysis of stud
ies, with consoled, computers and monitors shall be available to permit the
revision of images, the quantification of parameters and drawing up of
reports.An echocardiograph team shall perform between 10 and 14 studies
per shift. It is deemed that the necessary time to perform a conventional
echocardiogram, including interpretation, runs from 20 to 40 minutes.
This time calculation is in consonance with the recommendations of
the European Association of Echocardiography, which indicates that the
average time to perform an echocardiography study, shouldn’t be less than
30 minutes. These recommendations shall be the guide for programming
work schedules.
The BCS69,73 estimates the following units of relative value (factor of
weighting regarinding conventional TTE) for different echocardiography
examinations.
115
TTE in hospitalized patient: 1.5; TTE with training: 1.5; trans-oesoph
agus; 2; stress, 3; in the hospitalization unit: 2 or 3, depending on the distance
with respect to the echocardiography office; intra-operational: 6. In the
United Kingdom 90% of the TTE are performed by a «physiologist», with
an average daily performance of 12 equivalent TTE, per shift.
The times estimated by the BCS for cardiologists are: 45 minutes for
complex TTE (10% of the total); 60 minutes for trans-oesophagus, 180-240
minutes fro intra-operational trans-oesophagus; and 60 minutes for stress
echo-graphs.The average duration of a stress study with exercise shall be
calculated for 45 minutes and stress study with pharmaceuticals for 60 min
utes.
Equipment
High specialization of echocardiography imaging of the heart, since it has to
do with viscera which is moving, makes for the services and equipment
adjustments to be completely adapted and valid.
A summary of the minimum requirements which are considered at
present to be acceptable for echocardiography equipment, in accordance
with the norms for accreditation of echocardiography offices and the rec
ommendation for the performance, digitalization, storage and reporting of
echocardiography studies of the EAE are summarized in the following
points:
– The systems shall be specifically configured for cardiac applications
with the adaptation of software and adequate probes. They shall per
mit high quality images to be obtained, especially the availability of
a harmonic image, with high temporal-space resolution and a high
depth of the scale of greys.
– The complete capacity to perform Doppler studies in all its modali
ties, including continuous, pulsed means, Colour Doppler and tissue
Doppler (colour and pulsed).
– The systems shall be equipped with trans-thoracic phase-array
multi-frequency probes in the range of 2-6 MHz for children and 7
10 MHz for new-borns.
– A storage and digital connectivity system.
– Multi-frequency multi-plain probes are the present standard for
trans-oesophagus echocardiography.
116
Maintenance and renovation of the echocardiography
equipment
Although the echocardiography equipment is not as costly as other
imaging techniques in cardiology, it shall be subject to care and maintenance
to permit the rendering of quality imaging which directly affects diagnostic
precision of the technique, do not deteriorate with use and the passing of
time.
The time an echocardiograph machine can be maintained in function
ing order depends It is considered that the period from which an equipment
starts to be deteriorated affecting its performance and in which its technol
ogy becomes obsolete is five years.
That is why it is important that the equipment is optimally used, doing
it in morning and evening shifts, if its demand requires it.
Repeated damage to the micro-crystals of the trans-ductor, is a fre
quent cause of deterioration of the quality of the image of the echocardio
graphy equipment and, although care and protection measures of the
probes can slow it down, it is not infrequent that during the life of the equip
ment a renovation of the most used trans-ductors must be performed at
least once during the useful life of the equipment when more than 3.000
studies a year are carried out. To the daily cleaning and disinfection tasks,
carried out by the auxiliary office personnel, there must be added a program
of maintenance and periodic verification of the equipment, which can be
carried out by the technical electro-medical personnel of the hospital.
7.3. Cardionuclear medicine room and
equipment(66)
The Nuclear Medicine equipment, gamma-cameras and PET detectors are
normally found in the Nuclear Medicine Service. In general, the accessibili
ty and space characteristics shall be similar to the ones for echocardiogra
phy examinations, keeping in mind that their location for the administration
of radioactive doses shall be circumscribed within the radioactive installa
tion (Nuclear Medicine Service).
The gramma-camera equipment for the performance of Cardio
Nuclear shall be hybrid SPECT/CT, with double detector systems in vari
(66)
Depending on the services portfolio of the coronary area (population range).
117
able angle associated to a CT for attenuation correction. Cardio-dedicated
equipment exists with special designs which permit, for the same quality of
image, the reduction by half of detection time or the administered doses.
The PET/CT equipment for the performance of Cardio Nuclear shall
be systems with a capacity for cardiac and respiratory synchronization (gat
ing), CT for the correction of attenuation and for the performance of com
plete angioTC (with 64 or more crowns).
All Cardio Nuclear studies require a specific processing, with auto
matic systems of high reproduction which operate in advanced work sta
tions, with a large calculation capacity. At the same time, the performance of
tri-dimensional fusion of the functional images of SPECT and PET shall be
permitted with the anatomical images of the cardiac angio CT.
Generally a it shall be considered that a SPECT study of myocardial per
fusion shall be programmed in a space of 20 minutes for the stress test, 15 min
utes for the SPECT stress detection and 15 minutes for the gated SPECT
detection at rest (separated by a minimum of 90 minutes). For the detection of
isotopic ventricle-graph in equilibrium, 15 minutes are required for the mark
ing of erytrocites and about 10 minutes for planar detection. For the gamma
graph of myocardial in-nervation, an initial image of 10 minutes is required for
the administration of the doses of 123l-mlBG and the later image after 4 hours.
For PET studies (at present PET/CT in all cases) the programming of 60 min
utes is required for myocardial perfusion and 20 minutes (after a wait of 90
minutes) for the myocardial metabolism with18 FDG.
Picture 7.1. PET-CT room from the nurse station Picture 7.2. Gamma camera
118
7.4. MR and CT equipment
The MR and CT equipment are normally found in the radiology unit or
service, which requires the collaboration between radiologists and cardiolo
gists in the diagnosis through cardiac imaging, improving the indication for
each exploration, the performance of its interpretation and safety (Attach
ment 6).
The MR equipment for the performance of heart studies shall provide
a field, which as of 1.5 Teslas is considered adequate, and have available the
adequate gradient power and spools specifically designed for heart studies.
It must have, at least the specific software to perform morphological
sequences of black blood, white blood in cinema mode, contrast phase and
sequences designed to obtain in actual time the suppression of the myocar
dial signal for the study of late viability.
It must also have work stations with specific software to permit the
performance of the functional and morphological post-process required to
extract all the qualitative and quantitative information on all images
obtained.The CT equipment with the capacity to do cardiac studies must
have multi-detector, cardiac synchronization systems and specific software.
It shall have systems for modulation of doses which permit the significant
reduction of the radiation received by the patient. The equipment should
have the greatest temporal resolution possible with gyrating times lower
than 0.35 s and with the number of detector columns which permit the
acquiring of the heart in Apnoeas lower than 10-12 s.
At present it is considered that apt CT equipment for the performance
of heart studies should have, at least, 64 detectors, since the inferior amount
of equipment will render a higher percentage of non-interpretable or bad
quality studies.he equipment need to have The highly accelerate develop
ment of this technology and technique shall make centres with a high vol
ume of work consider the possibility of having ore modern and advanced
equipment. As with MR studies a work console with specific software for
the analysis of images is needed. In a general manner it shall be considered
that a Cardio MR study shall be programmed in a space of 60 minutes.
One Cardio CT study requires15 minutes of the machine and 30-45
additional minutes for the processing at the work console.
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Picture 7.3. MR from the nurse station
Picture 7.4. MR
7.5. The digital cardiac image laboratory
The obtaining, filing, processing and digital organization of cardiac studies
make up not only a great technological advancement, but also that the
organization and manner of work which it enables originates a different
concept and a new functioning «philosophy» in imaging offices. Digital stor
age has proven to be clearly superior to analogical storage support in imag
ing quality as well as accessibility. Therefore, the acquisition and digital fil
ing of the images permit the recuperation of studies with original quality,
rapid access and safety, make possible analysis through post-processing with
great versatility and enormously simply the healthcare and investigative
process. The basic structure of the digital imaging office requires:
– All the machinery for echocardiographs, cardio Nuclear, CT and
MR acquire the images digitally and send the acquired images to a
ventral server of PACS. The capacity of incorporation and visualiza
tion of the hemodynamic image shall also be recommended.
– Work stations connected to the server, where different studies can
be recuperated, reviewed and the necessary measurements made
and reports done.
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– All reports shall be loaded to the general information system of the
hospital so that they can be recuperated by any hospital doctor. In
some hospitals images can also be recuperated from any point in the
hospital and this probably shall occur in all centres in a short period
of time.
– All equipment and software shall fulfil as many standards as possi
ble, be they technical (DICOM, HL7) harmony (IHE) or semantic
(LOINC, SNOMED) to assure an integral behaviour even in an
environment of products from heterogeneous manufacturers, avoid
ing, when possible the inclusion of closed and ownership solutions.
Picture 7.5. Room for Diagnostic Imaging Reports
The function of the person responsible for the until will be carried out by a doc
tor, specialist in cardiology, who will have a specialized level in echocardiogra-
121
phy (level III), preferably having also preparation in Cardio Nuclear, Cardio
MR and Cardio CT. The general functions of the person responsible are:
• Organize the whole of the health professionals in a protocol and
assigned resources.
• To program the unit adapting the demand to the assigned resources.
• The coordination of the cardiology area for the elaboration of a
• To control the quality of the cardiac image.
The imaging unit shall have available the expert doctor specialists in
cardiac imaging and basically in echocardiography being that this is the
basic technique of the imaging office. The personnel of the unit will depend
on the amount of work. The comparisons of personnel provision between
countries are conditioned to the different structure of professional cate
gories, specialties and inter-professional competencies; especially the inexis
tence of technicians in echocardiography in Spain is considered a deficit
which shall be reduced.
In the case of existing echocardiography technicians it is esteemed to
be one cardiologist for each two technicians. Special techniques will require
the frequent collaboration of the cardiologist. The work on other imaging
techniques ideally demands the integration with other functional units, such
as in the area of nuclear and radio-diagnostic medicine. For an adequate
rationalization of resources, the non-echocardiography cardiac imaging
studies shall have an area of nuclear medicine and radiology, ideally with
the support of cardiologists trained in other imaging techniques.
It is recommended that the training of echocardiography technicians
be normalized which permits the increase of the rendering of available
resources, being able to estimate one technician for every 2.000 ETT equiv
alents, including continuous training, holidays and vacations, quality control
and administration. (see 7.2.). At the same time confronted with the expan
sion of the evolution of diagnostic techniques in Cardiology, it is recom
mended that channels of integral technical personnel training in different
diagnostic procedures (echocardiography, hemodynamics, nuclear medi
cine… etc.) be opened which permit a greater rationalization of available
resources in different diagnostic techniques.
Personnel with a university diploma in nursing will fundamentally par
ticipate in trans-oesophagus echocardiography, pharmacological echocar
diography and contrast echocardiography techniques. Given that their par
ticipation is indispensable for the performance of a great number of proce
dures, nursing personnel shall be incorporated in a stable manner to the
assigned imaging unit personnel.
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The dedication of an orderly to the unit will depend on the workload
and type of patients in the unit. In general, a patient in the hospitalization
unit is transferred to and from the echocardiography office by the orderly
or transport personnel and auxiliary management assigned to this unit.
Administrative support, with degrees similar to the rest of the hospital
and dedication to the unit according to workload. The integration of the
information from different echo-graphs in servers, the computerized clinical
record and voice recognition systems, have progressively made the need for
auxiliary administrative personnel be reduced.
Teaching and training
The field of cardiac imaging has seen itself revolutionized in the preceding
yeas due to the increase and development of new methods, basically CT and
MR, with the objective that these techniques permit the obtaining of a ben
efit to the patient and the performance of resources, cardiologists shall
understand the characteristics of the same and their use and limitations.
At present the training programs MIR are not designed uniformly to
acquire basic training in new emerging techniques. However, scientific soci
eties, and especially the European Society of Cardiology, include within
their recommendations the basic training for cardio Nuclear, cardio MR and
cardio CT for new cardiologists. Therefore, it is recommended that the resi
dent doctor acquire a training of level 1 in Cardio Nuclear, Cardio CT and
Cardio MR advised in a training period of three months, probably shared
during the last period of training in echocardiography. When this training is
not possible in the reference hospital, the means shall be structured to
obtain training in other hospitals in which these techniques are developed.
Three levels of training in echocardiography are considered for the
cardiologist in accordance with the practice guides published by the Span
ish Society of Cardiology:
– Basic level (Level I): minimum permanency of six months in an
echocardiography unit with teaching capacity.
– Superior level. (Level II); Permanency of six months, experience
given at this level is considered enough for the performance and
interpretation without a tutor of echocardiography studies.
– Specialized level (Level III): Minimum experience of 12 months in
total, this level of training accredits the management of an echocar
diography unit.
The training of the echocardiography technician demands the previous
training in radio-diagnostic imaging or a diploma in nursing. The expansion
123
of training levels to technical expert level in different techniques of imaging
similar to those existing is countries around us, is recommended.
124
8. Hemodynamics and
intervention(67)
The work of the hemodynamics unit has suffered a profound transtraining
in the last twenty years and, without abandoning its diagnostic objective, the
intervention procedures have acquired a leading role. The role of the
hemodynamics unit has evolved from the study of cardiac anatomy and
function, with sole diagnostic objectives and the evaluation of potential sur
gery candidates, to the therapeutic side of percutaneous intervention treat
ment through techniques based almost exclusively on catheters.
As new diagnostic and therapeutic modalities have been appearing
within the unit, the human and technical requirement, as well as the level of
training and competence of the personnel involved, has been modifying. As
mentioned in Chapter 2 of this document, the data combined from the regis
ter of SEC and EESCRI points out that, as an average, there are 1.7
hemodynamics rooms per hospital and 902 studies per year and room (1.076
al year in public and 582 in private hospitals) are performed.
The rate of diagnostic studies is situated around 3.000 studies per
million inhabitants and year, with a rate of around 2.700 coronary-graphs /
million inhabitants. In the registration data for 2008 the rate of coronary
intervention was 1.334 / million inhabitants, with a percentage of interven
tions in the IAM of 20.6% of the total.
The data of the MASCARA study points out the probable need for
the development of healthcare networks (integral emergency systems) and
the improvement in the functioning of all the nodes in this network, to
achieve better results in the handling of acute coronary syndrome with ST
elevation (Chapter 5).
8.1. Typology of intervention units
A normalized and generally accepted classification of hemodynamics /inter
vention units does not exist. IN accordance with organizational and mana
gerial aspects the following classification is proposed:
(67)
This chapter is based on the contributions, given for this document on standards and recom
mendations, by Javier Goicolea, updating the SEC's guide. Morís de la Tassa C (Coord.),
Cequier AR, Moreu J, Pérez H, Aguirre JM. Guías de práctica clínica de la Sociedad Españo
la de Cardiología sobre requerimientos y equipamiento en hemodinámica y cardiología inter
vencionista. Rev Esp Cardiol 2001; 54: 741-750.
125
The model of «freestanding unit» (unit not integrated in the health
centre) or the mobile hemodynamics laboratory have not been included in
this classification due to the existence of precedents in Spain.
Unit of reference intervention for the assistance
network
This is the most classic type of hemodynamics unit51. It corresponds to the
regional field units (@ 1-1.2 million inhabitants.), which bring together orga
nizational characteristic, human and equipment resources to develop a wide
office of services including some of the following cardiac intervention tech
niques:
– Percutaneous closing of Permeable Oval Foramen.
– Percutaneous closing of septo-atrial defects.
– Non-surgical reduction of the myocardial wall.
– Percutaneous laser revascularization of refractory chest angina.
– Percutaneous occlusion of left flap.
– Percutaneous mitral valveplasty.
– Percutaneous aortic valveplasty and percutaneous substitution of
the aortic valve.
– Percutaneous closing of acquired inter-ventricular communication.
It is important to point out that the totality of the aforementioned
techniques need not be incorporated to the reference unit as an essential
requirement; said techniques will be incorporated to the service roster
according to their prevalence, proximity to another reference unit, type of
126
patients attended to, etc. It is the reference unit for the performance of PCIp in acute coronary syndrome with ST elevation, which requires it be inte
grated in an integral emergency system and guarantee permanent coverage
(24 hours, 7 days a week, 365 days a year) for the performance of primary
angioplasty (see section 5.2).
It shall have available the following services in the same hospital51:
– Cardiovascular surgeryUnit of critical care (levels 2 and 3 of care).
– Vascular surgery.
– Nephrology and dialysis service or unit.
– Neurology service or unit.
– Hematology and blood bank service or unitImagery diagnosis, inclu
ding CT and RNM.
The unit should perform a minimum of 200 intervention procedures a
year, carried out by 2 hemodynamics specialists(68).
Each hemodynamic specialist shall carry out at least 75 angioplasties a
year(69).
The person responsible for the unit shall have at least 5 years of ade
quate experience in cardiac catheterization. The person in charge of the
intervention programme shall have experience of over 500 intervention pro
cedures.
Hemodynamics unit without service / cardiovascular
surgery unit
The hemodynamics unit shall be ideally installed in hospitals which include
cardiovascular surgery services. Reasons of accessibility derived from geo
graphic and population conditions (extensive geographic areas with dis
perse population) can justify occasionally having an intervention room
without cardiovascular surgery. The hemodynamics units without cardiovas
cular surgery services correspond to sub-regional field units, and entail
organizational characteristics, of human resources and equipment to deve
lop an extensive services portfolio, including invasive techniques, with the
following exclusion criteria:
(68)
Hemodinamic specialist: cardiologist with advance training in hemodynamics and interven
tional cardiology.
(69)
Accreditation system for the exercise of hemodynamics and interventional cardiology
aimed at professionals and training units. Hemodynamics and Interventional Cardiology Sec
tion of the Spanish Society of Cardiology. (www.hemodinamica.com).
127
The temporary coverage of the service will be adapted to the role of
unit within an assistance network. An alternative to be considered is the
participation of hemodynamics experts in this type of unit with on-call shifts
128
in the intervention unit.With the exception of the CCV, the same services
and support units as the intervention units shall be available. The hemody
namics unit in a hospital without cardiovascular surgery should have agree
ments which permit the derivation of the patient to a cardiovascular surgery
unit or service in a time inferior to 60 minutes209.
The unit shall perform a minimum of 500 coronary-graphs a year, done
by two cardiologists. Each cardiologist shall perform at least 100 catheteri
zations a year.
In the informed consent it should expressly state that, in the case of
urgent surgery, this will be performed in another previously contracted cen
tre.
It shall have available the person responsible for the unit, who shall
have at least 5 years of adequate experience in cardiac catheterization.
Satellite unit
Hemodynamics office located in a health centre without cardiovascular sur
gery and in which procedures are performed by hemodynamics experts who
belong to the personnel of the intervention unit of the network.
The procedures excluded from this type of units are seen in chart 8.2.
With exception of the CCV it shall count on the same services and
support units as the intervention units, including the cardiology service or
unit.
In the informed consent it should expressly state that, in the case of
urgent surgery, this will be performed in another previously contracted cen
tre.
The responsibility for functioning of the unit will correspond to the
person responsible for the intervention unit of the network, establishing the
corresponding agreements with the cardiology service or unit of the hospi
tal.
Each unit shall define its offer of services, that is to say, the offer of imaging
services which are performed in it, according to healthcare needs in its area
of influence, healthcare demands which have been identified, of technologi
cal resources on hand, of organizational and managerial characteristic and
the experience of its professionals. The activity registration form of the
129
hemodynamics and cardiology intervention section of the SECNon-defined
marker develops a complete offer of services, which permits the combina
tion of different types of processes and procedures linked to processes.
In addition to this, he will have experience and organizational qualities
to program work development, establish quality control of healthcare and
perform determined administrative work. Depending on the type of unit, it
shall be a cardiologist or an paediatric cardiologist with special interest and
knowledge of cardiologic intervention The director of the intervention pro
gram should have advanced formation in hemodynamics and intervention
and have enough experience with 200 annual interventions a year and a pre
vious experience of 1000 angioplasties. Accreditation system for the exer
cise of hemodynamics and interventional cardiology aimed at professionals
and training units. Hemodynamics and Interventional Cardiology Section of
the Spanish Society of Cardiology.
Among the functions which should be done by the person responsible
for the unit the evaluation of personnel functions and actions and the regu
lation of the activity in the unit, are included, delimiting the role and priori
ties for assistance, formation and investigation. The functions of the person
assigned resources.
– To control the quality of cardiac hemodynamics and intervention.
– To assure the collection of results to enable offering reliable data
from the unit, which can be included in official registers.
8.3. Process of healthcare to the patients in
the hemodynamics / intervention office
The major part of the patients who are examined in the hemodynamics offi
ce can be released to their homes in 2-6 hours. The patient upon which has
been performed a radial catheterization can be released 90 minutes after
the examination.
130
In table 8.3 appear the exclusion criteria recommended by the
ACCand in figure 8.1., taken from the same source, the journey for patient
care after the catheterization.
The origin and ambulatory destination of the major part of patients,
conditions the physical location of this unit within the health centre (see
chapter 11) as well as the need to have day hospital posts associated to the
same, which permit the adaptation of the patient on which a cardiac cathe
terization has been performed, to his environment.
131
8.4. Requirements of cardiac hemodynamics
and intervention Unit
In Spain there is no set of standards which define the organizational, struc
tured character in an integral manner and of resources for the cardiac
hemodynamics and intervention unit. In chart 8.4. an adaptation of stan
dards from the SEC guise by the SEC43, el ACC51 and BCS.
132
The duration of an average diagnostic catheterization can be estima
ted at 37.5 minutes (entrance – leaving of the office) and 90 minutes for the
coronary intervention, including primary angioplasty in the SCAST69.
In Chapter 11 aspects referring to physical resources of the CCUs’s are
gathered, including those referred to the cardiac hemodynamics and inter-
133
vention office, while in Attachment 7 the standards for structure and equip
ment recommended by the SEC are gathered, in Attachment 8 examples of
the dimensioning of the CCUs’s, in Attachment 9 examples of the functio
nal program related to dimensioning and in Attachment 10 those for equip
ment.
The diagnostic cardiac hemodynamics and intervention unit should include
personnel listed in the following: The typical team for the study is made up
of two hemodynamics experts (or three for two rooms), 2 nurses, a radiology
technician and a clinical auxiliary circulating between rooms for unforeseen
material before the procedure.
In Section 8.2 recommendation and standards in relation to the person
responsible for the cardiac hemodynamics / intervention unit have been
gathered.
The medical personnel linked to the unit shall have advanced training
in hemodynamics and intervention for the independent practice (not super
vised) as well as diagnostic studies such as intervention. The aforementio
ned shall apply above all for the performance during on-call duties where
practice is necessarily independent. In a Hemodynamics and Intervention
Unit, depending on its size, there can be a variable number of doctors at dif
ferent levels of advanced training, whether they be part of the staff or not,
who exercise their work under the supervision of accredited personnel. In
the centres performing interventional cardiology, the existence of a mini
mum of two hemodynamic(70) specialist is recommended.
Nursing personnel depends on the number and type of procedures. A
minimum of 2 nurses is absolutely necessary, specializing in hemodynamics.
They shall have knowledge in the cardiovascular field and shall be able to
assume the initial handling of the patient, the education and mental prepa
ration and the post-procedural supervision. The specialized nurse in
hemodynamics shall have experience in critical coronary care, knowledge of
cardiovascular medication, ability to place IV’s and experience with cardio
vascular instruments, with knowledge of hemodynamics material and expe
rience in its manipulation. Radiology technicians shall have technical kno
wledge of the cardiac catheterization laboratory, the principles and techni
(70)
With more than one room, 3 hemodynamic specialist may be enough for every two rooms.
The programming of the estimated complexity must allow it.
134
ques in radiological and angiographic imaging, with experience in the use of
X-ray generators and the system of angiographic injection.
They will be responsible for the normal care and maintenance of
radiological equipment having knowledge of the different software applica
tions and quantification systems. They will also have knowledge of the func
tioning and use of non-angiographic and physiological (intra-cardiac pres
sures and intra-coronary pressure guide) imaging systems (IVUS, OCT). At
the same time, they shall participate in the safety control of radiation to the
patient and personnel.
Human resources in primary angioplasty
The personnel which shall be involved in emergency procedures (funda
mentally primary PCI), shall include, as a minimum:
– A cardiologist with advanced training (level III) in hemodynamics
and intervention.
– Nursing personnel. It is necessary to have two nurses familiarized
with direct assistance to the procedure and sufficient (autonomy)
knowledge of the material. While the presence of an additional tech
nician is convenient, he cannot substitute the nurse in the clinical
work of healthcare to the critical patient or as an assistant in the
intervention.
– Support from the orderly / personnel for immediate transfer trans
portation and support.
Professional competencies of hemodynamics
angioplasty
In Attachment 11 the initiatives of recognition of the different levels of
advance training by the European and Spanish Cardiology Societies are
gathered.
135
9. Arrhythmia and
electrophysiology unit(71) 213
The advances experimented in the diagnosis and treatment of cardiac
arrhythmias, and the proliferation and complexity of the techniques used,
made for the development in the early 90’s of specific arrhythmia units for
their management. The possibility of registering intra-cardiac electric poten
tials and, at the same time, stimulating electrically the different cardiac
chambers, constitutes the basis of what is known as electrophysiological
study. In their beginning, said studies were basically used with a diagnostic
end.
At the end of the 80’s the electrophysiological studies passed on to
have a clear therapeutic vocation with the appearance of ablation through
radio-frequency. Since then the complexity of the treated substratum and
the techniques used has increased considerably. Due to this, the electro
physiological laboratory has converted into a centre for the making of very
complex therapeutic decisions which has lead to their conversion to
Arrhythmia Units.
As commented to in Chapter 2, the SEC registration of ablation gath
ers information provided from 59 centres, where 8.546 ablations (512 per
million inhabitants) were performed and an average of 145 ablations per
centre. 76% of centres have rooms exclusively destined for electrophysiolo
gy, 71% of electrophysiological offices are in «tertiary» hospitals and 82%
have cardiac surgery. The SEC ‘simplantable automatic defibrillator record
ings collect information provided by 134 centres. The number of implants
communicated was 4,108 (86.6% of the estimated total). The number of
implants estimated per million inhabitants is 100 per million inhabitants and
year. The amount of primo implants was 75.5%.
The increase in the number of patients susceptible to being seen in a
an office specialized in arrhythmias, the use of non-invasive diagnostic tech
niques, such as the Holter, the swinging test or the very periodical control of
the implantable device, make the electrophysiological laboratory impossible
(71)
mendations, by Josep Brugada and Julián Villacastín, actualizing the corresponding SEC guide:
Brugada J (Coord.), Alzueta FJ, Asso A, Farré J, Olalla JJ, Tercedor L. Guías de práctica clíni
ca de la Sociedad Española de Cardiología sobre requerimientos y equipamiento en electrofi
siología. Rev Esp Cardiol 2001;54:887-891.
137
to be conceived as an isolated entity, rather that it form a part of what we
denominate as the Arrhythmia Unit. Since the handling of the patient with
cardiac arrhythmias cannot be delegated from the general context of car
diac disease, said unit shall only be conceived as a part of the cardiology
area. The coordination with the genetic advice unit is very important to eval
uate those relatives of the patient with genetically determined disease and
who present a risk of sudden death.
To manage these patients, the electrophysiology laboratory in which
radiology equipment capable of visualizing the smallest electrodes is
absolutely necessary for the Arrhythmia Unit, together with equipment to
amp and tri-dimensionally reconstruct cardiac structures. All of that is nec
essary to be able to treat cases of major complexity, in which not habitual
accesses to the heart which can lead to risk situations for the patient with
possible grave complications which require immediate action.
These procedures can be very demanding from the human point of
view, lasting various hours and requiring sophisticated technology to be able
to be performed with the greatest safety and efficiency, besides requiring an
environment of surgical level asepsis. A highly trained human team is also
required, with a perfect coordination with the rest of the cardiology and car
diovascular surgery services.
The arrhythmia unit is responsible for diagnosis, treatment and follow-up of
patients with cardiac rhythm disorders. Ideally, the arrhythmia unit shall be
responsible for:
– Outpatient consultation for arrhythmias.
– Management of home monitored systems.
– Non-invasive studies: Holter, swinging test.
– Programmed electric cardio-versions.electrophysiological studies,
catheter ablations.Indication, implant and follow-up of sub-cuta
neous Holter, pacemakers, automatic defibrillators and cardiac re
synchronizers.
– Control and evaluation of the risk of determined electric genetic
pathologies.
In those centres where pacemaker units independent from arrhythmia
units exist, the unification of both shall be strived for with the objective of
optimizing material and human resources. To fulfil its work, the unit shall
have available adequate space, material and human resources.
138
Services portfolio
In the arrhythmia unit pathologies or processes in themselves can be diag
nosed and treated or those which are associated with and complicate chron
ic diseases. The most frequent are:
– Syncope.
– Arrhythmias which can be classified as curable (intra-node tachy
cardia, WPW syndrome, common flutter, mono-focal auricular
tachycardia, idiopathic ventricular tachycardia and some forms of
auricular fibrillation).
– Ventricular tachycardia.
– Brady-arrhythmias (auricular-ventricular blocks, sinus dysfunction)
which can precise pacemaker implants.
– Patients with heart failure susceptible to the implantation of bi-ven
tricular stimulation directed to delaying or improving their symp
toms.
– Patients with diseases which predispose them to sudden death in
which the knowledge of their risk and often the implantation of a
defibrillator is needed.
Person responsible for the arrhythmia unit
The arrhythmia and electrophysiological unit of the cardiology area should
have a person responsible, doctor specialist in cardiology, with advanced
formation in arrhythmias and electrophysiology. The functions of the person
assigned resources.
– Quality control of studies and interventions.
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9.2. Arrhythmia and electrophysiology unit
There isn’t a group of standards in Spain which integrally define the
requirements of organizational, structural and resource character of an
arrhythmia and electrophysiology unit. In the chart 9.1 an adaptation to the
SEC’s42 guide and of the BCS’s standards was made:
The average duration of a diagnostic electrophysiological study is 1 –
2 hours. For a therapeutic study 2 – 3 hours can be estimated and for com
plex ablation procedures (ventricular tachycardia, auricular fibrillation) the
duration is about 3 – 6 hours (entrance to– departure from office) (Hacket,
2003). Other estimated times are:
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9.3. Electrophysiology office
The arrhythmia unit shall have available those facilities which permit ful
filling its objectives and which include:
– Electrophysiological office.
– Location for the carrying out of swinging test and cardio-versions.
– Consult for clinical appointments and defibrillator control, re-syn
chronizer and pacemaker, with areas dedicated to the analysis of the
results of patient tele-monitoring.
– Holter (see 6.2.3.).
– Access to a genetic laboratory.
– Hospitalization area (its own or included in the general area of hos
pitalization), with access to areas with telemetry in some cases, and
to intensive care areas for complex cases (ventricular tachycardia,
patients recuperated from sudden death or complex ablations).
The electrophysiological office should have the possibility to do stud
ies in a continuous manner214,215. Electrophysiological studies, ablations with
catheter and, depending on each hospital and the agreements between car
diology and cardiovascular surgery, pacemaker, defibrillator and re-syn
chronizers are carried out in the laboratory.
The office shall be located in an area with easy access to other rooms
which can be necessary at a determined time, such as the hemodynamics
laboratory, the coronary unit or the cardiac surgery operating room.The lab
must hace at least two separated rooms: the catheterization room and the
control room. The catheterization room shall be under aseptic conditions (in
case that the room is used for implants, it shall have air conditioning and be
isolated from a type B operating theatre and be sufficiently wide so as to
have room for a catheterization table, radiologic equipment, amplifiers,
monitors, 3-D mapping systems, radiofrequency generators, complete cario
plumonary resuscitation equipment (CPR), infusion pomps, etc. The table
must be located so as to allow access from both sides and there shall be vac
uum and oxygen intake near the table head and all the requirements for
mechanical ventilation systems and general anaesthesia use.All auxiliary
equipment such as registers, stimulators, monitors and printers shall fit in
the control room. It shall be separated from the catheterization room by a
lead wall and also a lead window. All the connections between the catheter
ization room and the control room shall be isolated, through separate con
ductions and away from passing areas. Fibre optic wiring connections would
be ideal to avoid interferences. All equipment shall be conveniently isolat
ed with earths.
141
Radiological equipment
The radiological equipment is a fundamental part of the laboratory213,215,a)
procedures which can require extremely prolonged scope times (more than
60 minutes in some cases); b) the exposition to radiation by patients and lab
oratory personnel being high, and its reduction to a minimum requires cer
tain technical conditions of the equipment, to take extra precautions with
protection measures and a strict work discipline; c) «mapping» and ablation
procedures require the immediate obtaining of multiple radiological pro
jections as well as the fusion of different modality images such as CT and
MR and d) it is necessary to have a storage system for radioscopic images
in the DICOM format, temporal (which permit the comparison of catheter
positions during the procedure) as well as permanent (for posterior analy
sis, comparison in the case of a second procedure and the obtaining of
copies).
As explained in the introduction, the increase in the complexity of pro
cedures which are carried out in the electrophysiology laboratory requires
high quality, definition and rendering systems.
Due to all of that the use of flat detectors instead of image intensifiers
is recommended, common portable imaging systems shall not be used, at
least in the principal room in the case that there more than one in the Ser
vice.on large field (23-25 cm) and which permits the global vision of the
heart and another smaller one (15-17 cm) for the precise placing of
catheters. It shall be kept in mind that the use of small fields increases the
dose of radiation. The adequate adjustment of the collimators to the field
which is being explored reduces disperse radiation.The most important
technical elements for the reduction of the dose of radiation are constitut
ed by the use of digital systems of pulsated scope and systems of spectral fil
tering. The pulsated scope permits pulsations of greater amplitude to those
of a continuous scope, improving the quality of the image without increas
ing the dose.
The spectral filterer eliminates the component of disperse radiation
which affects above all the personnel which works in the room next to the
patient.The pulsated scope systems of 12.5 or 8.3 images/s can provide a
good quality image for electrophysiological and ablation procedures.
Another important element to reduce the dose of radiation to the doctor
performing the catheterization is the crystal lead wall hanging on both sides
of the tube and overlapped with another wall hanging from the ceiling.
According to what has been described inR.D. 2071/1995, of December
22nd,the use of dose measurement and registration systems is
mandatory.http://www.derecho.com/l/boe/real-decreto-2071-1995-estable-
142
cen-criterios-calidad-radiodiagnostico-%5Bdisposicion-derogada%5D/For
the storage of radiological images, transitory as well as permanent, the use
of storage systems in digitalized imaging format discs DICOM is recom
mended.
Other equipment
Aside from radiological equipment, the electrophysiology laboratory shall
include: a) electric amplifiers, physiological signal registers and adequate
monitors; b) an electric cardiac stimulator; c) radio-frequency generators; d)
a cardiopulmonary reanimation system including an external synchronized
defibrillator with the possibility of administering bi-phase shock; e) a tran
sitory pacemaker battery, f) tri-dimensional mapping systems, g) the avail
ability of an anaesthesia team and, h) non-invasive monitoring systems: Pul
sioximetre and non-invasive TA monitor. According to the specialization of
the laboratory additional equipment can be available such as a crio-ablation
generator, intra-cardiac echo-graph system or robotized equipment for
ablation.
The physiological register (polygraph) has as its purpose the collection
of presentation of electrophysiological data, permitting its analysis, immedi
ately as well as afterwards. The register can include monitoring of vital signs
of the patient during the procedures, The register shall permit the simulta
neous obtaining of various endo-cavity signs, conveniently filtered and
amplified, along with various electro-cardiograph surface referrals. It is
absolutely necessary that it can obtain registrations on paper at different
speeds (25 to 200 mm/s). Ideally the register shall permit the simultaneous
obtaining of the 12 referrals of the surface electro-cardiogram and between
16 and 128 endo-cavity signs.
At the same time, it shall contain the possibility of registering quality
bi-polar and mono-polar signs. The register shall be isolated so that it not
receive interferences with radio-frequency due to the danger of losing the
signs at the moment of applying energy. The new registration equipment are
almost all of them based on digital signs with computerized support which
permit the obtaining of many signs simultaneously, as well as their storage
on optical discs and their laser printing.
The electrical cardiac stimulator shall permit stimulation using a wide
range of frequencies, with the possibility of introducing multiple extra-stim
uli, with programmable and synchronized connections to its own or stimu
lated activity. The intensity and duration of the stimulus shall be program
mable.
143
The generators of radio-frequency shall be adapted according to the
catheters to be used as well as the new sources of energy. The resuscitation
system shall include all the intubation, cardioversion, drugs administra
tion,... material. The equipment, specially the external defibrillator, shall be
regularly checked in order to assure it correct functioning at all times.
The tri-dimensional mapping systems are absolutely necessary in any
laboratory that carries out procedures of medium and high complexity.
The type of system will depend on each laboratory but it shall permit
tri-dimensional reconstruction of the cardiac anatomy in real time and the
representation of the electric activation of the different cavitiesFinally, in
many cases echo intra-cavity systems must be available, to exactly situate
anatomical structures as well as to guide punctures such as trans-septal, for
example.
The arrhythmia unit should have the adequate personnel for the perform
ance of appointed216,217, tasks which are listed as follows:
In section 9.2., the recommendation and standards in relation to the
person responsible for the arrhythmia unit have been gathered.Complex
ablation procedures and electrophysiological studies require the presence
of at least two specialized doctors who have training in clinical electrophys
iology, as well as diagnosis and treatment of cardiovascular complications
which can be derived from the procedure.
One of them has completed a training program in clinical electrophys
iology and directs the procedure, controlling registrations and programmed
stimulation, and the other one tends to the introduction and handling of
catheters. Ideally, the two electrophysiology doctors shall have exclusive
dedication in the arrhythmia unit, especially if the same is in charge of pace
maker, automatic defibrillator and cardiac re-synchronizer implantation
and follow-up.In section 12 the SEC requirements for the training of an
electrophysiology cardiologist are gathered.
Personnel who are not doctors shall include a minimum of two nurses
(or one nurse and one technician). In the procedures, the nurse is responsi
ble for the preparation, sedating, medication and vital constants of the
patient. The other one will be responsible for material, radiological control
and radiofrequency generators handling. The other one will tend to materi
al, radiological control and handling of radio-frequency generators and car
diac re-synchronizers; the presence of a specialized nurse or technician to
help in this function is absolutely necessary.
144
In the laboratories with tri-dimensional mapping systems, the figure of
an engineer (or another trained person) who controls the system and helps
with the preparation and obtaining of activation maps, and the integration
of real MR or CT images with a virtual mapping system, is absolutely nec
essary. Without this figure, it would be very difficult for the laboratory to ini
tiate and maintain a program of complex stratus ablation, type auricular fib
rillation or ventricular tachycardia.10. Cardiovascular Surgery Service.
This chapter is based on the contributions, given for this document on
standards and recommendations, by Joseba Zuazo, Miguel Josa and José Mª
Cortina.The cardiovascular surgery service is an organization with a hierar
chy of cardiovascular surgery specialists, which acts within the framework of
a tertiary hospital organization and which attends to the prevention, study
and treatment of heart, pericardium, large vessels and peripheral vascular
system. The management of this organization is carried out by a cardiovas
cular surgery specialist with ample professional recognition and leadership
capacity.
Cardiovascular surgery collaborates closely with all the UAC’s, unify
ing diagnostic and treatment criteria, optimizing the use of resources and
establishing a control program for quality assistance and improvement. At
the same time, its activity is inter-dependent upon the Anaesthesia Service
and the organization of the Surgical Block and the Imagery Diagnosis
Department, especially Angio-radiology. In Spain, the access to post-gradu
ate formation to obtain the degree of specialist in cardiovascular surgery
(CVS) is carried out through the MIR system and after completing an
accredited education program.
The degree of CVS for surgeons from other countries with approved
degrees can be obtained through the MSPSI, with a recommendation from
the commission of the speciality. The European Board of Thoracic and Car
diovascular Surgeons, made a proposal of the unified European degree of
this speciality, which was jointly created and organized by the most impor
tant European scientific societies of thoracic and cardiovascular surgery: la
European Association for Cardio-Thoracic Surgery (EACTS), la European
Society for Cardiovascular Surgery (ESCVS) y la European Society of Tho
racic Surgeons (ESTS).
The principal objectives of this European organism have been 1-to
harmonize postgraduate training of new specialists, and 2-to obtain the
recognition and approval of different Cardiovascular and Thoracic Surgery
specialists existing in the member countries of the European Union. At
present time, the certification by the European Board of Thoracic and Car
diovascular Surgeons has a voluntary character and is done through a sole
exam for all countries concerning the knowledge and capacity of the candi
dates in the speciality.
145
10. Cardiovascular surgery
service(72)
The cardiovascular surgery service is a hierarchical organization of cardio
vascular surgery specialists that works in the framework of a tertiary level
hospital organization and that is in charge of the prevention, study and tre
atment of diseases of the heart, the pericardium, large vessels and periphe
ral vascular system. The management of this organization is carried out by
a cardiovascular surgery specialist with wide professional knowledge and
leadership capacity.
Cardiovascular surgery works closely with all the coronary units, unif
ying criteria in terms of diagnosis and treatment, optimizing the use of
resources and establishing healthcare quality controls and improvement
programmes. Likewise, is activity is mutually dependent on the Anaesthesia
Service, the Surgical Unit organization and the Diagnosis Department for
imagery purposes, especially Angioradiology.
In Spain access to postgraduate training to obtain a specialist degree
in cardiovascular surgery (CCV in Spanish) is done through the MIR (exa
mination to become a resident medical intern) system and after completing
a accredited teaching programme. The qualifications in cardiovascular sur
gery (CCV) of surgeons from other countries with comparable degrees can
be obtained through the Ministry for Health, Social Policy and Equality, on
the speciality committee recommendation.
The European Board of Thoracic and Cardiovascular Surgeons, a pro
posal for a unified European degree in the specialty, was jointly designed
and organized by the most important European societies in thoracic and
cardiovascular surgery: the European Association for Cardio-Thoracic Sur
gery (EACTS), the European Society for Cardiovascular Surgery (ESCVS)
and the European Society of Thoracic Surgeons (ESTS). The main goals of
this European body have been 1) harmonizing the postgraduate training of
new specialists, and 2) being acknowledged and recognized by the different
specialists in cardivascular and thoracic surgery in the EU member States.
At the moment, the certification by the European Board of Thoracic and
Cardiovascular Surgeons has a voluntary nature and is obtained through a
single exam for all the countries on the knowledge and skills in the candi
dates’ specialty.
(72)
mendations, by Joseba Zuazo, Miguel Josa and José Mª Cortina.
147
10.1. Cardiovascular surgery activity
The registration data on the SECTCV activity showed that surgical activity
in Spain has been maintained relatively stable, from the year 2001 to the
year 2009, with an approximate number of major procedures over 18.000
cases annually. The lack of growth is attributed to the reduction of coronary
surgery during this period (25%) due to the use of therapeutic trans-cathe
ter coronary techniques, which in Spain have had a higher proportional
increase with respect to the appreciable changes in other countries.
In contrast to those countries, in Spain valve surgery is still predomi
nant. In the year 2008 the distribution by types of surgery showed 29% of
coronary surgeries, 41% of valve surgeries, 10% of combined procedures
and 8% of aorta procedures. Paediatric surgery represented 9% of the total,
without variation during this period.
The data for the year 2008 showed a reduction of the number of car
diac transplant of 9% during the period.In conjunction to the number of
CCV in the year 2008 they were slightly superior to 450 procedures per
million inhabitants, a number very inferior to other European countries
which move between 600 and 700 procedures per million inhabitants.
Despite the stability of the activity volume throughout the last few
years, the structural demand has been increasing due to the greater com
plexity in patients referred for surgical treatment. Despite continuous war
nings of the SECTCV against the increase of cardiovascular surgery servic
es, the number of centres with CCV in Spain has grown a lot during the last
10 years, making the activity per centre to be very reduced.
Therefore, in the year 2008 the average of major procedures per cen
tre was 371 cases. We shall consider an optimum number of procedures to
be over 600 cases per centre/year and in Spain only 6 centres reach that
number, while many do 200 procedures per centre/year. 600 cases of cardiac
surgery in the adult (excluding congenital cardio-pathology) mean, for real
frequency, population fields of about 1.5 million inhabitants. The atomiza
tion of the activity is an important factor in the increase in costs and the
reduction of quality.
Services portfolio
The CCV covers pre-operation, per-operation and post-operation process in
the following pathology groups:
148
– Acquired anomalies of the heart pericardium and large vessels.
– Congenital anomalies of the heart and large vessels.
– Thoracic aorta pathology.
– Pathology of the supra-aortic trunks.
– Circulatory healthcare.
– Heart transplant.
– Heart-pulmonary transplant.
To do this activity it is necessary to carry out indispensable procedures
and techniques which are mentioned as follows:
– Perfusion and extracorporeal techniques.
– Cardio-circulatory stopping and cerebral perfusion techniques.
– Perfusion techniques with reduced circuits.
– Cardiac surgery techniques without extra-corporeal circulation.
– Trans-catheter valve implantation techniques.
– Implantation of arterial and venous catheters for monitoring and
the establishment of dialysis.
– Mechanical healthcare through counter-pulsation balloon.
– Circulatory healthcare of short, medium or long duration.
– Implantation of an artificial heart.
– Respiratory healthcare.
– Implantation and extraction of defibrillator pacemakers.
– Implantation of defibrillators.Implantation of prosthesis and other
endo-vascular mechanisms.
– Pulmonary thrombi-endarterectomy.
– Surgical ablation of auricular fibrillation.
– Cellular regeneration therapy.
Organization of cardiovascular surgery
Cardiovascular surgery is an organization of specialists of CCV with a hie
rarchy, which acts in the framework of a tertiary healthcare centre. The per
son responsible for the management is the head of the service, whose fun
damental functions are:
– To organize professionals to adequately cover the activity of surgery
in the different surroundings in which it is developed.
– To organize activity protocols in a consensus manner with the rest of
the surgeons and CCUs.
– To establish areas of special action, naming a responsible member in
each one.
149
– To be responsible for the registration of activity, the analysis of
results and quality programs.
– To organize the adequate management of patients.
– To stimulate basic, clinical investigation among the members of the
Service, the publication of studies and the healthcare to scientific
forums.
– To make sure that the education program fulfils the expectations of
the CNE.
– To manage the general resources of the service.
The person responsible should maintain a level of adequate knowled
ge in his area; establish action protocols which should be followed by the
rest of the members; participate and leader multi-centre work groups for
med by members of the UAAC’s, who are not cardiologists; participate in
the SECTCV registers; and leader investigation projects in his areas.
The professional structure and the designation of responsible people
of inferior rank depends on the capacity of activity and needs for each cen
tre. The activity of the cardiovascular surgery members shall be global, that
is to say, all members are capable of carry out one of the previously descri
bed activities, which permits for a relatively small group of professionals to
adequately maintain the selected activity and emergencies at all times.
However, it is necessary for some particular activities to be directed by at
least one surgeon with a special interest, capacity and dedication and who
develops a specific experience in them. Without being exclusive, the desig
nation of people responsible in the following areas is very recommendable.
– Ischemic cardio-pathology.
– Valve repair surgery.
– Treatment of aorta pathology.
– EndocarditisAuricular fibrillation.
– Circulatory healthcare and cardiac transplantIntensive care and
hospitalization are.
– Registration of data and quality programs.
– Teaching.
10.3. Resources in cardiovascular surgery
The necessary resources for the development of Cardiovascular Surgery
are:
150
Out-patient consultations
Out-patient consultations of CCV are organized in a similar manner and
with the same resources as in other cardiology areas, and they have alre
ady been described.
Surgical activity
Operating room characteristics of CCV have been made reference to in
chapter 6.
From the beginning of anaesthetic induction until the departure of the
patient from the operating room, a conventional cardiovascular surgical
procedure lasts no less than 4 hours. With the gradual increase of comple
xity of patients operated on, the duration of surgical procedures are much
more prolonged.
To perform an activity of 600 procedures (extra-corporeal circulation
and aorto-coronary grafts without extra-corporeal circulation)/year an ave
rage duration of 4 hours (for these procedures) and an occupation of 70%
for an operating room used 248 days a year, 7 hours a day, two operating
rooms dedicated to this end shall be available.
Upon the termination of the surgical procedures, the clinical register
of the patient should show times used in all phases of the procedure, iden
tify the professionals involved in the same and their responsibilities, and
include(73) the Surgical Report, the Anaesthesia Report, the Perfusion
Report and the Nursing Report.
The necessary personnel to perform a cardiovascular procedure inclu
de:
– A minimum of two surgeons, both CCV specialists. In complex pro
cedures three surgeons are necessary, at least two of them specialists
in cardiovascular surgery.
– At least one anaesthesiology expert with special interest, dedication
and preparation in cardiovascular surgery.
– At least one anaesthesia support nurse.
– At least an instrumentalist nurse with a special preparation and
devotion to CVS.
– At least one instrumentalist nurse with special preparation and
dedication to CCV.
(73)
See: Bloque Quirúrgico. Estándares y recomendaciones. NHS Agency of Quality. 2009.
151
– A minimum of one accredited perfusion specialist. In the situation
of two simultaneous procedures in two operating rooms, the recom
mendation is for three perfusionists, one of which will act as profes
sional support.
All necessary tools in the operating room are not described as they
are, in great part, standard. The list of structures and specific systems for
the cardiovascular operating room is detailed in Attachment 13.
Post-operative intensive care unit(286)
The results of the surgical procedures depend in great measure to the qua
lity of post-operative care. The complexity of the evolution of a great num
ber of these patients requires the healthcare of highly specialized personnel
and, in the measure the healthcare volume advises it, on the support struc
ture differentiated from other intensive care units.
On the other hand, an important group of low risk patients evolves
rapidly, can be ex-tubated early and can be attended to in less specialized
units.
In our country, many centres do not have available differentiated
intensive care and the general units attend to very diverse patients, among
them cardiology and cardiovascular post-operatory ones. The critical car
diovascular care unit attends the patient with a 2 or 3 level of care, be it car
diology or a cardiovascular surgery and would permit synergies between
both specialties within the concept of the CCUs. The variety of organizatio
nal and post-operatory managerial models of CCV makes it difficult to esta
blish a defined model.
The availability of intensive post-operation beds depends greatly on
the organization and structure of each hospital The gradual increase in the
complexity of patients has increased considerably the average stay in an
intensive care unit of CCV. It is calculated that the average stay of 4.5 days,
so that for an activity of 600 patients of extra-corporeal circulation per year,
the CCV would generate a need for 9 intensive care beds.
If the CCV service has available a circulatory healthcare activity, car
diac transplant, pulmonary endarterectomy etc., the number of beds shall be
risen. The rapid, active and efficient post-surgical recuperation programs
(«Fast Track») can modulate the necessities of beds as well as their distri
bution in care levels. The structure, systems and necessary apparatuses for
(74)
See: Intensive care unit. Estándares y recomendaciones. NHS Agency of Quality. 2010.
152
the functioning of a unit of these characteristics and for an activity of 600
patients / year are detailed in Attachment 14.
Hospitlization(75)
The unit of CCV hospitalization has similar characteristic to the rest of
multi-valid hospitalization units, necessarily counting on the specific tools
detailed in Attachment 15.
Support
Including offices and conference room.
10.4. Quality in cardiovascular surgery
The quality of the activity of Cardiovascular Surgery is not an intuitive and
subjective concept, rather an objective and measurable process which per
mits the establishment of continuous improvement interventions which
benefit the patient and the institution. The quality program is based on a
great collective effort of discipline in the documentation of surgical facts
and a great reliability in analysis methods. Cardiovascular Surgery is one of
pioneer medical disciplines in the development of self-evaluation systems
and external auditing of its activity.
Internal activity registers
All groups shall have a well-designed database which permits the accumu
lation of clinical data for all patients evaluated and/or treated. The collec
tion of data shall be complete and the facts collected analyzable. The varia
bles collected shall have a clear and univocal definition and it is recommen
ded that these definitions be adjusted and organized in an identical manner
to the other databases.
(75)
See: Unidad de enfermería de hospitalización polivalente de agudos. Estándares y reco
mendaciones. NHS Agency of Quality. 2010.
153
In Spain, many CVS services already use these databases of basically
clinical character. The responsibility for the good functioning and exploita
tion of this database falls on the Head of the Service or person responsible
for the Unit, who shall impose on the members the necessary documentary
discipline to obtain quality registers. It is advisable to name a member of the
service or unit as the person responsible for this very important activity.
The database used shall include detection of error and absence of data
mechanisms, to permit the analytical exploitation of data, their exportation
to complex statistical analysis programs, and other registers collaborating in
the format which these registers require.
Institutional activity registers
The majority of centres are developing large internal computerized structu
res which permit the accumulation of extensive administrative and clinical
information about all patients related to them. These large computerized
structures have a great importance for the institution and for daily medical
practice, but cannot reach the specificity nor the agility of specialized clini
cal databases. Both systems are perfectly complementary and benefit each
other mutually. These institutional activity register systems are very impor
tant for the CVS quality program and are absolutely necessary to dedicate
the same grade of discipline and reliability on the part of CVS members to
the quality of information on their patients in those systems.
National activity registers
Since 1984 the SECTCV hold a voluntary register of activity and raw mor
tality not stratified according to risk, with the aim of obtaining reference
data allowing to analyse in a very general way the annual evolution of this
activity. The bast majority of national CVS services are included in this
register, but it must be considered that around 9% of services are not sen
ding their annual reports.
However, the SECTCV obtains additional information by other means
obtaining an error index of around 5% of the surgical activity in Spain.
Although this register is not totally complete, it is a very useful acceptable
reference for the CVS services in order to compare their activity and mor
tality with the global one of the group and in each CVS section, and to find
out with more accuracy the raw mortality of CVS in Spain. The SECTCV
keeps other activity and result registers active, such as the one of Mechani-
154
cal Circulatory Assistance, for which the Working Group of this activity is
responsible, and the Ablation Register, for which the working group of
arrhythmia and cardiac stimulation is responsible.
The activities of these groups and others such as the one of Aortic
Disease, Valve Repair or Quality analyse joint results and establish criteria
and action protocols applicable to the different services of CVS.
Internal activity registers. Risk assessment and
scoring (Scores)
The register of the Society of Thoracic Surgery (STS) Adult Surgery Database, the STS Pediatric Surgery Database, the register of the European
Association of Cardiothoracic Surgery (EACTS) in cardiac surgery of the
adult and the EACTS Congenital Data in congenital cardiac surgery. These
registers have accumulated data from carious hundreds of thousands of
patients in the USA, and Europe permitting them to carry out studies based
on the great volume of activity. The analysis of these patients characteristics
in relation to the results obtained, has permitted the creation of risk punc
tuations, the stratification of surgical results according to risk level and the
creation of risk prediction charts (Scores).
The EACTC or EuroScore in the most used punctuation in
Europe.The SECTCV has created and sponsored a quality work group and
has named the person responsible for this group. The SECTCV gathers the
reports sent to all the Spanish participating centres which, once encrypted
and accumulated, are sent to the European Register. At the same time, this
group responds to the SECTCV with a comparative evaluation of activity
and results according to global figures obtained in Europe, which are sent to
different services. All the process is carried out in conditions of maximum
confidentiality. On the other hand, the progressive accumulation of patients
permits a gradual improvement in risk punctuations.
Each service can study the observed mortality results adjusted to risk
in each surgery group and compare them with those expected. Evidently, the
relation between one and another shouldn’t exceed the unit and it is very
advisable to obtain results under 1. Results superior to 1 should be a moti
ve for the introduction of improvement mechanisms. Participation is volun
tary and in Spain about 8 centres do it every year.
The participation of the CCV services in this type of programs is highly
recommended and shall be considered as an indispensable condition for the
accreditation of a teaching centre.The importance of the adaptation of the
rapeutic indication and rigorous analysis of results is clearly illustrated in
155
the last report of the European Register of Cardiac Surgery in the
Adult.The last report of the European Register in the year 2010 includes
the analysis of data from more than a million patients, among them the
16.629 patients send by 12 Spanish centres. The number of participating
Spanish centres has been on the increase progressively and their geographic
distribution is extensive, and although the present volume is still low, the
results can be considered a reference, although restricted to the sample. It
shall be mentioned that the quality of the data sent by the Spanish centres
is of the best in the European register.The results for Spain are being analy
sed now, but there is a report available including interesting data regarding
coronary surgery, isolated in our country.
A surprising fact which this report shows is that the proportion of
coronary surgery over the total volume of cardiac surgery in Spanish cen
tres is the lowest in Europe, with a difference of 30% with respect to nor
thern and central European countries and 25% with respect to the group of
countries in southern Europe. These marked differences suggest that the
therapeutic attitude in Spanish centres with respect to isolated coronary
surgery is very different from that of the countries in the rest of Europe,
including those in the same area, with similar environmental and social
surroundings.
Another outstanding fact from the European report is that the avera
ge EuroSCORE of patients operated on in 12 Spanish centres is, with a
great difference, among the highest in Europe. This is a determining factor
in the evaluation of the results of coronary surgery in Spanish centres, which
show in this report a crude mortality superior to the European average,
while mortality adjusted to risk is inferior to said average. In contrast to
some postulations based on the crude mortality published annually by the
SECTCV, the quality of the coronary surgery in those Spanish centres is
similar or even better to that of the rest of European countries.
The actualized and rigorous knowledge of the results and their strati
fication by risk shall be a fundamental tool in internal and external auditing,
not only of the activity of the Cardiac Surgery Services, but of all activities
developed within the Area of the Heart.
Quality indexes
The CCV service or unit shall maintain quality indexes in different phases
of the activity which permit the evaluation of the functioning of areas and
structures. The indexes shall remain registered in a computerized program
and analyzed by pre-fixed periods. The most common are stated:
156
– Patient management. Cancellations and delays in surgery (Inferior
to 10%. Indicate causes).
– Surgical process: Change of planned procedure (Inferior to 10%.
unexpected finding; per-operation complication, error in the initial
procedure).
– Post-operation evolution.
– Ventilation more than 48 hours.
– PneumoniaAcute renal failure.
– Neurological alteration which prolongs stay.
– Self-ex-tubation.
– Aspiration.
– Re-operation due to bleeding or cloggingInfection of the woundIn
fected catheter.
– Release with adequate appointments and medication.
– Mortality. A situation which shall always be associated to evaluation
in the mortality session.Request index and acceptance of post-mor
tem study.
– Mortality Sessions. The mortality sessions are absolutely necessary
in a quality program. The post-mortem study shall be requested in
all deceased patients.
– EuroScore. A relation between observed and expected mortality of
«1» or inferior to «1» in the analysis of global results or any other
group of surgery. Numbers superior to the unit shall initiate analysis
and improvement processes.
Improvement actions
Confronted with any unsatisfactory quality index it shall be established that
corrective actions will be placed into action, in which manner the effects of
these actions are to be documented and in what time in the future a new
evaluation will be carried out. If the quality indexes are satisfactory, new
quality objectives will be established at a higher level for the following
period.
Professional accreditation
The cardiovascular surgeons shall have and accredit degrees in Medicine
and Surgery and the degree in the Speciality of Cardiovascular Surgery.
Post-graduate teaching in the CCV services or units can only be performed
157
under accreditation of the MSPSI. It is recommended that all members be
accredited by the European Board of Cardiothoracic Surgery. It is recom
mended that surgeons be members of the SECTCV and can show their par
ticipation and activity in the society conferences and other forums sponso
red by it. The Head of the Service shall stimulate the participation in the
EACTS.
Institutional accreditation
The EACTS has established criteria for the voluntary accreditation of CCV
services. The accreditation has a validity of 5 years, after which it shall be
renewed. The accreditation of a service is determined following the evalua
tion and recommendation carried out «in situ» by an evaluating group
designated by the EACTS. The process is paid for by the institution. At pres
ent time there are only two accredited services in Spain and another in the
process of accreditation.
The quality program in CCV shall include and fulfil the following
requirements:
– An adequate volume and distribution of groups of patients.
– A basis for the collection of reliable data. It is advisable to use one
of the collection systems at present in use in Spain.
– Participation in a register of activity and collective results. The regis
ter of the EACTS is advisable.
– Results adjusted to calculable risk by EuroScore.
– Global satisfactory EuroScore and in all groups of patients.
– Well structured mortality sessions.
– Quality indexes and improvement mechanisms.
– Professional accreditation of all its members.
– Teaching accreditation of the service by the MSPSI.
158
11. Physical structure of the
healthcare units of the
cardiology area
In this chapter the criteria and recommendations referring to the structural
and functional conditions of the UAAC’s are developed with reference to
the zones which are specific to the same and therefore are not shared with
other functional units of the hospital, and which have not been included in
more extensive functional units such as, emergency, multi-service hospital
ization, critical/intensive care, surgical block and rehabilitation, whose char
acteristics are treated in other documents of standards and recommenda
tions. In this chapter a brief review of these units will be done making ref
erence to those specific points which apply to the Area of the Heart.Cardi
ological healthcare is given, apart from in the specific imaging and inter
vention offices (hemodynamics / coronary-graph and electrophysiology),
The zones which are considered to be specific to the Area of the Heart are:
– Zone for access and receptions areas.
– Zone for out-patient consultations.
– Zone for exploration offices for central functions.
– Zone for hemodynamics / Intervention / catheterization laboratory.
– Zone for the medical day hospital.
– Personnel zone.
The adopted structure shall respond, in each case, to the functions, and to
organization and functioning criteria, established in the functional program.
The whole of the specific zones of the UAAAC is located within the
ambulatory area of the hospital in a place which serves ambulatory patients
as well as in-patients, and which, due to the activity developed in it, as well
as the very fact of constituting the nucleus of the diagnosis and treatment of
the Area of the Heart, is the place in where the work zone for professionals
of that area is included.
11.1. Functional program
The functional program shall establish the size of the different zones and
physical resources which are integrated in the CCUs’s, through the analysis
of the different components of the offer and demand, which include:
159
– Demographic analysis of the health area to be attended to, or the
market study for private establishments. This demographic study
shall consider population projection for about 10 years.
– The study of the demand for resources established in the roster of
services of the different healthcare modalities. The study of person
nel needs and equipment of the Unit attending to the demand, pre
vious activity and the roster of services previously defined.
– Description of the organization and functioning of the unit.Descrip
tion of the healthcare process (the means of access to the patients,
the transit within the unit, the departure alternative, etc.), and the
functional relations with the rest of the surrounding services and
units. Dimensioning of resources of the unit.
– Analysis of other factors which can affect the demand: hospital
patients, functioning and dimensioning of the surgical block regime,
seasonal variations in population, location of the hospital in relation
to infrastructures, transportation and existence of regional catastro
phe plans defined by civil protection.
– Analysis of space necessities for different users of the unit.
11.2. Space relationship with other hospital
units. Location within the hospital
The UAC should maintain a space relationship of proximity to other hospi
tal assistance units, which should be produced through the internal circula
tion destined for in-bed patients, personnel and supplies. A high level of
proximity (preferably at the same level) between the hemodynamics zone
and the intensive care unit and surgical block shall exist.
At the same time, the UAC shall have good internal space relationship
with emergency, radio-diagnosis, multi-service hospitalization, as well as
with rehabilitation (cardiac physiotherapy) and pharmacy.
11.3. Specific physical resources of the UAC
The physical resources of the different units can be shared or exlusive for
any one of them, according to the characteristic and size, defined in the
functional program, and the space location of each one of the zones.The
integrated location of the different zones of the area, located between exter
nal (ambulatory patients and accompanying people) and internal (in
patients, professionals and supplies) circulation.
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The area oriented to the patient will tend to integrate in a same phys
ical area the different resources which integrate the unit, especially those
with relation to reception, consults and special central exploration offices.
The integration of the different zones of the area permits the concentration
of all necessary resources for its organization and functioning and enables
the concentrated location of the professionals of the same.
The space localization of the unit in the hospital shall consider health
care needs for ambulatory as well as in-patients, maintaining a relation of
proximity (which is desirably resolved at the same level) in the case of
hemodynamics, intensive care and the surgical block.
The progressive extension of the roster of services in the hospital in
which the availability of reserve space has been unforeseen for the specific
resources which they entail, in the same zone, has determined different solu
tion which affect the configuration and level of integration of the different
zones which make up part of the area.
The list with the locales of each one of the zones of the Area of the
Heart is expressed in Chart 11.1.
The basic characteristic for each one of the locales which integrate it
are established for each zone as follows, establishing recommendations con
cerning the diverse aspects related to functional and environmental condi
tions which shall be required in relation to the established functions and cri
teria for organization and functioning. These recommendations are applica
ble to new units as well as interventions to functioning units.
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Zone for access and receptions areas
This zone is destined to the development of resources destined to relatives
and visitors of ambulatory patients who access the hospital through the gen
eral access area of the ambulatory hospital, and through external circulation
of the same.
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Reception, appointments and information
In the access to the unit, a counter and an administrative work zone, which
serves for the reception of ambulatory patients is available.
Alongside the access, the availability of a space for wheelchairs is rec
ommended.
Waiting room for outpatients / paedeatric waiting room, public toilets
From the vestibule of access to the unit there will bean access to the waiting
room for relatives, in whose proximity will be found the nucleus of public
restrooms, at least one of which shall be adapted for the use of invalid peo
ple in wheelchairs.
It is recommended that the sitting room have natural illumination, sized
according to programmed activity, installation for a water fountain, etc.
Cardiac patients shall have a different sitting room with a specific rest
room containing a zone which permits baby changing and the parking of
strollers.
Information office
At the same time, in the surroundings of the access to the unit there shall be
an information office, which is set up with the objective of holding inter-
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views with relatives and/or patients and to educate in relation to care and
healthcare to the patient at home, with adequate conditions of privacy.
The furniture of this office shall be warm, with comfortable seats, and
a residential atmosphere.
Consultation zone
The access and reception zone defined, serves for the consultation zone, as
well as, generally for the zone of functional central explorations, so the con
sultations remain associated to the exploration offices without a delimited
zoning. In this case, which is recommended in general, it is necessary to
locate the heart area so that it permit access to ambulatory patients as well
as in-patients.
In this situation, the consultations locales are found in the closest
external circulation zone and the central examinations offices, associated to
the internal circulation of the hospital.
This solution permits, at the same time, the availability of a series of
locales (clean closet for pharmacy and fungible material, cleaning job, dirty
job, bed-clothes storage room, equipment storage room, rest and dressing
rooms for personnel) shared between the consultation zone and the central
functional examination offices.
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Multi-Service consultation
The locales of consultation and exploration should be of a multi-service
character:
The consultation offices should have a minimum size of 3.30 by 5.50
metres (18.5 useful m2), with two areas, office and consultation, and explo
ration.
The consultation offices shall have an installation for oxygen and vac
uum.
The consultation offices shall have a zone for hand washing and space
for the storage of material.One consultation office shall be adapted for the
healthcare to paediatric patients.
Waiting room
According to the number of consultation locales (and central functional
exploration offices of the Unit), small locales are recommended for the stay
of patients associated to the consultations.
Nursing consultation
With a work counter and space for fungible and pharmaceutical material,
linked to the consultation locales.The nursing consultation space is the cen
tre of communications of the zone, necessarily having the communication
infrastructure, as well as the terminal for the pneumatic transport installa
tion.There shall be located in this consultation a space for the resuscitation
cart (defibrillator). This equipment shall be located in a visible place, with
out obstacles for its transfer through the Unit.
Zone for special central exploration offices
In this zone, non-invasive explorations are carried out, on ambulatory as
well as hospitalized patients, so it is recommended that it be found in the
same physical space as the external consultation zone and share with it, the
reception and admission to the Unit of the Heart zone, so that human (sec
retarial and administrative work) and physical (waiting room, information
office….) can be shared.
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This localization permits the sharing of many of the necessary
resources and support for the functioning of the zone, as well as to connect
the internal and external circulation of the hospital.
At the same time, it is recommended that this zone of Central Func
tional Exploration Offices of the Heart Unit be placed in a close location,
adjacent to the Hemodynamics / Intervention / Catheterization Laboratory.
This relation of proximity permits the concentration of the resources of the
Unit, sharing the resources of the Day Hospital, as well as other support and
personnel resources. And, mainly, it permits the grouping of all the neces
sary resources for the healthcare to patients who find physical and profes
sional resources related to their pathology in the same place in the hospital.
In the zone of Central Functional Exploration Offices diverse analysis
of patient cardio-respiratory functions are performed such as: ambulatory
monitoring of blood pressure; stress tests, analysis of implantable apparatus,
echo-cardiographs (trans-thoracic, trans-oesophagus, 3-D, stress and con
trast), echo-cardiograms….
All the patient exploration locales shall have a space and installation
for hand washing and for the storage of material. At the same time, the
totality of the exploration locales shall have a centralized installation for
medicinal gasses, oxygen and vacuum. The cleaning of the rooms shall be
intense so the surface materials (walls, floors, ceilings, furniture) shall be
hygienic and easily cleanable.
All the rooms shall have an individual control over the climate instal
lation.Some of the exploration rooms shall be prepared for the healthcare
to children who shall be able to be accompanied by their parents while the
exploration is performed.
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Echocardiography
The room shall permit the stay and movement of the ambulatory as well as
bedded patient, with the possibility of being accompanied, with space for an
echo-cardiograph (trans-thoracic, trans-oesophagus, 3-D, stress and con
trast) and in the case may be, a cardiologist and an echo-cardiograph tech
nician.
At the same time, space for a portable echo-cardiograph shall
exist.There shall be enough space for the patient to be accessible on all four
sides of the bed or chair. For the performance of a stress and trans-oesoph
agus echo-cardiogram, additional equipment is required (pulsioximetre for
the measurement of the oxygen level, storage of probes….).
In this case, the movement of the chair shall permit the downward
inclination of the upper part to prevent the sedated patient from vomiting
Conventional trans-thoracic echo-cardiography (ETT)
The following specifications for conventional trans-thoracic echo-cardio
graph rooms shall be available:
– Rooms with adequate space for multi-service explorations for
ambulatory as well as bedded patients.
– A minimum useful area of 20 m2 (with the smaller side not inferior to
3.6 metres) is recommended, with two cabins with hangers for the
patient’s clothes, which serve as a dressing room, and a place for the
deposit of the patient’s belongings (purses, clinical documentation, etc.).
– Installation of medicinal gas and vacuum sockets which fulfil safety
specifications demanded by legislation.
– The rooms shall have a climate and ventilation system.
– A gurney adjustable in height, inclination of headboard.
– Movable and fixed perfusion system stands on the exploration gur
ney.
– The chair for the person performing the exploration shall be ergo
nomical and adaptable in height, providing comfortable explo
rations.
– Wide doors and accesses which permit a more than wide enough
space for beds and material (IV stands, consoles, respirators…).
– A width of 1.20 m. in the case of one door and 1.60 m. for a double
leaf door.
– Electric sockets and digital connectors dedicated to the echo-car
diograph system.
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– Curtains and/or screens to assure privacy.
– Sphingomanometers.
– Sink.
Trans-oesophagus. Echo-Cardiography (ETE)
For the performance of an ETE it is preferable to have larger rooms than
the conventional trans-thoracic echo-cardiograph. Besides this, the labora
tories which perform trans-oesophagus studies, in which sedation is usually
used, shall have installations which permit for the observation and recuper
ation of those patients.
The average duration of a trans-oesophagus study shall be calculated
at 30-45 minutes. The trans-oesophagus echo-cardiograph of paediatric
patients requires general anaesthesia, requiring a room with oxygen, vacu
um and nitrose oxide installations.
On the occasion of this type of exploration in paediatric patients, it
shall be performed in the catheterization laboratory room.It is recommend
ed that these locales have a useful area of 28 m2 (with the smaller side not
interior to 4.5 metres). The room should serve ambulatory as well as hospi
talized patients.
Beside the aforementioned standard characteristics, the work-posts
where ETE is performed requires the following additional installations:
– Electrocardiograph.
– Non-invasive monitoring of arterial pressure.
– Pulse oximetreSecretion aspiration system.
– Centralized oxygen installation.
– Advanced cardio-pulmonary reanimation.
– Locked cupboard for drugs and pharmaceutical registration sys
temA means of rapid notice (telephone, inter-phone)A large sink
for the washing of trans-oesophagus probes.
– Disinfection traysSystem of verification of electrical leaks in the
ETE probes.
– Exhaust fan to prevent the accumulation of gases emanated from
the solutions used for the disinfection of the probes.
Stress echocardiograph
The stress echocardiography can be carried out with stress (treadmills for
marching or bicycles) or through pharmacological stress. Although the dif-
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ferent modalities of stress have the objective of the induction of regional
movement abnormalities to the wall which are produced with myo-cardiac
ischemia, the tests differ with respect to patient preparation, protocols and
equipment.
The dimensions of the room are similar to those of the trans-oesopha
gus echo-cardiograph, and serve at the same time for ambulatory and hos
pitalized patients.
Besides the standard characteristics, the work posts where the stress
echo-cardiograph is performed require the following additional installa
tions:
– High level echo-cardiograph machine with software for the study of
incorporated stress.
– Acquisition system for digital image.12 referral electro-cardiogram.
– Non-invasive monitoring of arterial pressureErgonometry (tread
mill / bicycle).
– Continuous infusion pumps for the administration of pharmaceuti
cals, IV.
– Emergency equipment.
– Peripheral catheters, syringes, infusion pumps, etc…stress pharma
ceuticals (dobutamin, dipiridomol…) and other agents. Atropine,
Aminophiline, echo-cardiograph contrasts, etc.
The average duration of the stress study with exercise shall be calcu
lated at 45 minutes and the stress study with pharmaceuticals at 60 minutes.
Recuperation room
For examinations requiring the patient to be sedated (transesophageal
echocardiography).
This room, with an oxygen and vacuum installation, must be linked to the
echocardiography examination rooms and nearby the area’s nurse station.
Ergometry
This room is destined for the ambulatory patient and should cover the pos
sibility that he be accompanied, and attended to by two physiologists and, if
the case may be, a cardiologist Surrounding the patient there should be
enough space for him to be attended to.
There must be enough space around the patient to be treated. The
room is equipped with an ECG installed on a portable cart, a sphingo-
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manometer for the measurement of blood pressure, as well as a work station
equipped with a computer. At the same time, it shall have equipment for
stress tests, bicycle or treadmill for racing.
Electrocardiograms (ECG)
Each room shall be capable of attending to one patient who can be accom
panied and attended to by one physiologist and occasionally by a cardiolo
gist.
As in the rest of the exploration rooms, the dimensions of the room
and the elements of access shall be designed for the use by ambulatory as
well as bedded patients.
Each room shall have at least one cabin to facilitate the preparation of
the patient.
In the case of having a common room for the performance of ECG, the
patients shall have adequate privacy during the performance of the test.
Holter
In this room ambulatory holter patients are installed and the equipment for
the recording of ECG and blood pressure for 24 hours.
The room shall have space for the storage of portable equipment.
Records room
Equipped for the analysis of explorations (Holter, echo-cardiograph….),
and computers.
According to the organization and space disposition of the different
zones of the Unit, and especially the Personnel Zone, the records room shall
be located in this zone.
Room for analysis of implantable mechanisms
With installation and equipment which permit the analysis and program
ming of implantable mechanisms in patients.
The room shall have a chair to accommodate the patient, which shall
be accessible on all sides to professionals and equipment.
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Nursing control
The central functional exploration offices zone shall have a control post for
nursing personnel to work, which will be located in the central zone with
respect to the exploration locales of the patients, to minimize routes and
facilitate the vision and rapid access to the patients with urgent healthcare
needs.
All patients can require to be accessed by RCP equipment with defib
rillator, as well as oxygen and vacuum installation. This equipment shall be
located in a defined space and accessible to the nurse station.At the same
time, the patients can require the supplying of medicinal gases, oxygen and
vacuum, for which it is necessary that all locales (consultations, offices, hos
pitalized patient waiting rooms) in which a patient is attended to must have
centralized medicinal gas, oxygen and vacuum installation.
The control post will have a counter with a surface for personnel work
and communication equipment installation, including the central reception
of calls to the nurse and space for the storage of work material, as well as a
personnel work zone, which will have a clinical station for the access to the
hospital information system and the work with the computerized clinical
record.
Next to the personnel work counter a terminal for the pneumatic
transport system of samples and documents, as well as diverse alarms and an
installation panel are located.
Associated to the counter and work zone of the control post there are
different support locales for the functioning of the personnel of the zone:
clean closet, hospitalized patient waiting room, patient recuperation room,
dirty closet,…
Clean closet
In the room linked to that counter zone and personnel work zone, there is
a clean closet with a work zone for the preparation of clean material, sink,
refrigerator for clinical use, cupboards, automatic medicine dispensers and
fungible material.
This room serves for the storage under safety conditions (refrigerator
and freezer) of medicine and clean and sterile therapeutic material.
The shelves and material trays should be separated enough from the
floor to permit the easy cleaning of the same.
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Hospitalized patient waiting room
For the stay of the bedded hospitalized patient, before the performance of
a functional exploration in this zone.
It can also serve for patient recuperation after an exploration, which in
general is resolved in the medical day hospital zone, which shall be located
in a zone nearby which is connected to through internal hospital circulation.
This room shall be located in a a place within the internal circulation
office zone, near the nurse station. It shall have an oxygen and vacuum
installation.
Fungible material storage room
Space for the storage supplies for the functioning of the zone.
Linen warehouse
Like the rest of the material, the size and characteristics of the clean clothes
storage room depends on the policy for storage and management, and the
frequency of distribution. Normally it is carried out on carts which are peri
odically replaced.
Equipment warehouse / workshop
It is necessary to have a room with ample access for the storage of equip
ment, pacemakers and portable equipment. The room shall be equipped
with open shelves as well as a free space for large equipment.
The room shall have electrical sockets to permit the recharging of
equipment batteries.
Electrical sockets at a height which prevent professionals having to
bend over are recommended. The room shall have a small workshop table
to enable the service technician to perform repairs which can be done in the
room or calibrations of material, as well as a file for the follow-up of mate
rial incidents.
Cleaning closet
This room serves for support to the daily activity of the cleaning service.The
room shall have a sink and a counter, space for mobile equipment storage
and cleaning material for rooms and zone equipment.
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Soiled closet and waste classification
The dirty job should be located next to the nurse station, and will have
enough space for different containers to be located which make the
advanced classification of clinical, infectious and urban waste possible. It
shall have a clinical sink and tip.
Personnel toilets and dressing rooms
The locales destined to rest and dressing rooms for professionals in the
zone, are located in a place near the access by professionals to the zone
through internal circulation of the hospital.Their size will be in accordance
with the number of rooms and the type of programmed explorations.
Interventional procedures area (hemodynamics /
electrophysiology)
This unit should be located in the medical day hospital zone with which it
can share all its resources: reception, patient dressing room, waiting rooms,
and patient recuperation rooms.Ideally, this zone shall be located next to the
rest of the zones which integrate t he cardiology area, sharing locales and
human resources, facilitating the healthcare to patients and concentrating
personnel and equipment resources.
In this zone, ambulatory as well as in-patients are attended to, so that
like with the whole of the area, it can be available between external and
internal hospital circulations.
This zone can have good space relations (through internal hospital cir
culation) with the intensive care unit, surgical block (cardiac surgery),
Emergency room, as well as with multi-service hospitalization units. The
relation with the hospitalization units serves to assure a greater perform
ance of activity in the zone, since the in-patients in the multi-service hospi
talization units do not require urgent healthcare in this zone.
In this zone exploration, diagnostic and treatment work is carried out,
which require invasive techniques, and which include, among others, cardio
version, coronary angio-graph, electrophysiology studies, percutaneous
coronary interventions, ablations through radio-frequency, closing of auric
ular and ventricular wall defects, mitral valve-plasty, insertion of complex
implantable devices.
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Hemodynamics room / electrophysiology room
The existence of ideally at least one room dedicated to hemodynamics and
one room dedicated to electrophysiology is recommended.
In the case of the volume not justifying it, the existence of a multi-serv
ice room (hemodynamics / electrophysiology) can be considered. It is rec
ommended that the size of the room be at least 7.5 x 6.0 metres (45 m2 of
useful area). These dimensions are justified by the occupation of profes
sionals in the room (about 6 people) and the equipment which includes a
digital angio-graph (normally installed over a foundation), installation of
gases (oxygen, medicinal air, vacuum, anaesthetic gases) and other technical
devices (electrical sockets) which are installed in towers with articulate
arms, fixed to the ceiling.In function of the type of intervention that is per
formed, the required room sizes can rise.
In the case of electrophysiological studies and ablations through radio
frequency, more teams of professionals are needed, more control monitors
(up to 6) and complementary equipment, so the recommended dimensions
for the room are 7.5 x 8.0 metres (60 m2 of useful area).From the ceiling are
also hung monitors which show in actual time the intervention which is
being performed on the patient.
This group of monitors (about 4) shall be situated in a manner so they
can be adequately observed by the professionals without impeding access to
the field around the patient. It is recommended that the free height of the
room be not inferior to 3.0 metres.The position of the patient shall permit
the movement of the radio-diagnostic equipment arch with iso-centric gyra
tion) as well as access to the patient by the professionals in the surrounding
field.There are, at the same time, other devices and equipment necessary for
the intervention which are normally available on portable carts (contrast
means injector), as well as other material (medicine, catheters,….) which are
placed in closed cupboards in the room.
There are also computers (one for nursing) which can be located with
in the room and/or in the control room of the same.
Other material which shall be located in the room are, the stop cart
(defibrillator monitor and trans-cutaneous electrodes placed at the head
board of the patient), in-tubation systems (laryngoscope and tubes), oxygen
application, ventilation systems, aspiration catheters, as well as the possibil
ity of including an electro-cardiograph and echo-cardiograph machines. The
use of radio-diagnostic equipment implies the need for protection from
ionic radiations generated, which normally is resolved through the lead
plating of all the surfaces in the room.
It is necessary for the electrical in-put of the radiological and poly
graph equipment be independent, with exclusive circuits for that equip
ment, having the pertinent insulation.
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The room has the technical characteristics of an operating room (see
the document of Standards and Recommendations relative to the Surgical
Block Unit). At the same time the observations and recommendations con
tained in section 6.1.1, 4 (Implications of circulation in the interior of the
surgical block and ventilation of the operating room for the control of noso
comial infection»), corresponding to said document, which affect the
designs with circulation segregation, are to be applied.
Hybrid operating room
The term «hybrid operating room» indicates that operating room in which
the cardiologic radiology imaging equipment is integrated, so that radiolo
gy and vascular surgical interventions prove to be appropriate. In theory it
permits the development of new therapy techniques, and a greater safety for
the patient in this type of interventions which incorporate multi-disciplinary
teams of cardiologists, cardiac surgeons, vascular surgeons and radiology
interventionists. In particular, it permits attending to an emergency or com
plication during a vascular catheterization treatment through the perform
ance of a surgical intervention. In reality, the hybrid operating room is an
operating room with a cardiac catheterization laboratory integrated. At the
same time, this solution makes possible the post-operation therapeutic
supervision.
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The integration of the imaging equipment implies the synchronized and
automatic functioning of the same with the surgical table and shall have an
adjustable height as well as a carbon fibre board, without metallic elements,
for the performance of radiological explorations.
The imaging equipment shall be suspended from the ceiling through a spe
cific structure so that it facilitates the movement of the same for the length
of the operating room. This structure shall be compatible with the rest of the
elements (surgery and anaesthesia towers, surgical lamps, imaging screens,
general illumination of the room, installation of laminar flow if the case may
be, etc.) which are located in the ceiling of the operating room.
The most common imaging equipment in the hybrid operating room, is the
angio-graph, although it can be equipped with a computerized tomo-graph
or magnetic resonance. The first hybrid operating room installed 10 years
ago in Switzerland, still functioning, integrated a fixed CT and angio-graph,
with a surgical table which would move between both pieces of equipment,
situated at the extremes of the longitudinal axis of the same.
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The hybrid operating room is located in the general surgery block of
the hospital sharing the general resources of the same. The hybrid operating
room requires locales with specific and differentiated characteristics with
respect to the general operating room. In particular, it shall have the fol
lowing locales and useful areas, integrated in the same zone:
–
–
–
–
–
–
Operating room: 60-70 m2.
70 m2 Imagery equipment control room: 20 m2.
Technical Room: 10 m2.
Personnel preparation (hand washing): 8 m2.
Patient access and preparation: 12 m2.
Sterile material storage: 10 m2.
The minimum free height of the operating room shall not be inferior to 3.00
metres (in accordance with the imaging equipment to be installed), with a
minimum height of a false ceiling of 1.2 m.
There isn’t enough information available to evaluate the relation
between cost and profit of these structures in comparison to the more tra
ditional solution (hemodynamics room and operating room).
Control room
The intervention rooms will be communicated visually with the control
room through a leaded glass window. Said window located at the smallest
side of the intervention room, in front of the patient’s table, on the opposite
side of the radiology equipment.
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From this room the radiology system of the intervention room is con
trolled, being equipped with at least two work stations. The locales can be
shared by two intervention rooms.
The control room shall have an independent access from that of the
room.
Minor cardiac procedure room
In this type of rooms, procedures can be performed in a safe environment,
in which the risk of infection is low and the recuperation of the patient is
short. At the same time, it can be an alternative space to the interventions
rooms in which procedures which are not complex, such as the implantation
of some devices, can be performed.
It is recommended that the dimensions of the room for this type of
procedures not be inferior to 6.5 x 4.5 metres (useful area of 29.95 m2). It
shall be capable of housing portable radiology equipment, simple (arch), as
well as monitors, material carts for the carrying out of surgical procedures,
etc.
The room shall have a centralized installation for medicinal gases
(oxygen and vacuum), anaesthetic gases and electrical sockets (normally
resolved in towers with articulated arms affixed to the ceiling), as well as
radiological protection against ionic radiations.
The location of the room with these characteristics in the UAAC zone
permits the sharing of the rest of physical and human resources which the
intervention has: patient preparation and recuperation room, personnel
preparation, personnel dressing room, sterile material storage, dirty closet,
etc.
Personnel preparation
The personnel access to each intervention room requires having a previous
personnel preparation zone (hand washing), located in the proximity of the
local destined for personnel dressing and rest rooms.
This room shall have a minimum of three water sources per interven
tion room, with automatic action surgical faucets, antiseptic dispensers, hand
dryer and clock.
At the same time, there shall be available a space for the storage of
caps and masks, as well as the collection of paper wrapping.It is desirable to
have a window (with leaded glass) above the intervention room.
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Sterile storage room
The room for the depositing of sterile material, surgical tools, devices and
fungible material.
It shall have positive pressure with a climate control system with
absolute filters.
A space for anaesthesia material is, at the same time, required.
This storage room will be situated in a zone near the intervention
room.
Equipment warehouse / workshop
For the localization of portable equipment.
Dirty closet and waste classification
It is recommended that this room be located in direct connection with the
intervention room.
Locale for the deposit of dirty clothes and waste classification, to be
transported by means of carts and containers distributed by the waste man
agement system of the hospital.
The room shall have a water source and enough space for advanced
waste classification.
Technical equipment room
Locale with climate control for the housing of transformers, uninterrupted
feeding systems, generators and central unit of the digitalization system. The
spaces for the climate control equipment for the zone shall be located in the
exterior of the floor (fro example on the roof) and the closest to the rooms
it serves.
Technical facilities room
Air-conditioned, to locate the transformers, uninterrupted power supply
systems, generators and central digitalization system unit.Shall be located in
the intervention room and isolated from radiation. So that the healthcare
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activity not be affected by periodical maintenance work on the equipment
and the functioning of these not reduce environmental quality to the unit.
The result of the work in intervention rooms is the radiological image,
which is filed to permit later analysis and transmission.
At present, it is understood that the acquisitions, filing and transmis
sion systems of the image shall be digital.
The standard DICOM 3.0 defined the physical and logical format to
the exchanging of data (patient images and data) between the different
equipment, with independence to their manufacturers.
The filing of digital images in servers connected to work stations or
terminals is recommended, which permits a rapid access and quality,
enabling direct communication with other units and healthcare centres.
Preparation / Patient recuperation room
There shall be a room for patients’ preparation, and, if the case may be,
recuperation, although this is normally carried out in the Medical Day Hos
pital of the Heart Unit.
This room should be located in the proximity of the access to inter
vention rooms and alongside the nurse station It should have a centralized
oxygen and vacuum installation. It should have an oxygen and vacuum
installation.
Waiting room for hospitalized patient / recuperation
A room is required for the holding of hospitalized patients and, if the case
may be, recuperation after an intervention. It shall located in a space con
tiguous to the nurse station of te zone, and have a centralized oxygen and
vacuum installation. Each post shall have a space for the placement of a
monitor.
Nursing control
From the nurse station post the reception and continuous observation of the
intervention zone is carried out. It shall be located in the proximity of the
preparation and recuperation rooms of the patients after an intervention,
preferably with a certain amount of privacy between posts, as well as having
a specific space for paediatric patients.
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The control post shall have a telecommunications centre, pneumatic
tube for samples, central alarm system for the zone and specific space for
the stop cart.
Clean closet in the room linked to that counter zone and personnel
work zone, there is a clean closet with a work zone for the preparation of
clean material, sink, refrigerator for clinical use, cupboards, automatic med
icine dispensers and fungible material.
This room serves for the storage under safety conditions (refrigerator
and freezer) of medicine and clean and sterile therapeutic material.The
shelves and material trays should be separated enough from the floor to
permit the easy cleaning of the same.
Cleaning closet the local for the storage of cleaning tools and products.
With a sink and tip.
Medical work / Report room
Open room for the situation of various personnel work posts and an area,
for the analysis, interpretation and valuing of images, equipped with voice
and data terminals. It shall have, at the same time, a small meeting area.This
room shall have a digital work station which permits the visualization of
images obtained in the interventions rooms.
Doctor’s office
Office for the writing up of reports after interventions, with computer and
telematic connections.
Multi-Service meeting room
Multipurpose room equipped with IT and data transmission services.Multi
service room with enough space for the holding of clinical sessions, teach
ing, formation, residents, with equipment which permits the application of
tele-medicine (video-conference, imaging connection to intervention, teach
ing rooms, etc.).
Living room / room for snacks for the staff.
Locale for the resting of the personnel, equipped with a small space for
the conservation and preparation of light food and drinks. It includes hav
ing a sink and a small storage space.
184
Personnel restroom and dressing roomsLocales destined for rest and
dressing rooms for the professional teams of the zone, situated in the zone
next to the personnel preparation room connect to the intervention room.
Its size will be according to the number of rooms and the type of pro
grammed interventions.
Medical day hospital zone
The functions and structural characteristic of the medical day hospital are
referred to in the document «Standards and Recommendation: Medical
Day Hospital Unit (HdM)», published (2008) by the Ministry of Health.
In accordance with the foreseen work burden in the functional pro
gram, this area can be sued specifically for the heart unit, supposition con
sidered within and therefore developed in a complete form.
The medical day hospital shall be located in an area near the CCUs
healthcare resources, especially in the intervention zone. Iin the case that it
be located in a space associated to the same, it can share physical and human
resources, facilitating the patients of the unit.
This area shall have an access for ambulatory patients differentiated
from hospitalized patients, personnel, services and supplies. The locales
which integrate this area of the unit are:
185
186
Reception and access
This premise will incorporate the necessary space for the healthcare to the
patient and the people accompanying him (a certain grade of privacy shall
be kept in mind) during the admissions process in which personal data,
determination of appointments, organization of lists and foreseeing of
errors, communications with patients, etc. area carried out.Administrative
admission procedures for the patient, if necessary, are also carried out. The
administrative area will have the necessary equipment to efficiently devel
op its activity (computing, e-mail, telephones, fax, answering machine for
after working hours) and prepare a space to keep specific documentation:
protocols, information brochures, etc.
The reception counter will be designed in a manner which makes it
accessible from the main entrance and easily located by patients and people
accompanying them, and, that reception personnel can observe the entrance
door and public circulation.
It is recommended that all administrative procedures are done, as long
as possible, in the very reception counter, avoiding the need for adjacent
offices.
It is considered that, in new designs, the information system shall inte
grally support the development of all activities, including, besides those
merely considered to be administrative, the management of clinical docu
mentation.
Waiting room for patients and people accompanying them
(with adapted toilets)
Adjacent to admissions, there shall be a space for the patients and relatives
to wait, which can be the same used for waiting during treatment and recu
peration.
It will be a comfortable area and will have restrooms, telephone, tele
vision and an automatic cold water fountain.
The size of the waiting area will depend on the foreseen activity and
the social-cultural characteristics of the population, counting on 1.5 com
fortable seats (waiting time can be long) per patient which is to be found in
any area of the unit.
This main waiting room will have preferential direct access from the
entrance vestibule, will permit visual contact with the reception counter and
will provide access to the day hospital area, especially consultations and
patient posts.
187
Next to the main waiting room there will be a restroom area for the
public, including one adapted to invalids, with sink and toilet. Its size will be
proportionate to the size of the waiting room.Information office.
Locale to provide information to patients and/or people
accompanying them under privacy conditions
Doctor’s office the healthcare prior to treatment in the unit frequently
requires exploration, diagnosis, selection of the patient after clinical evalua
tion and indication of therapeutic measure to be taken. Besides this, it is
necessary to facilitate the pertinent information to the patient and get his
consent.
These functions are developed in the consultation area, their number
being in relation to the volume of activity and schedule. It is assumed that
consultations shall permit in one space the combined activity of consulta
tion and exploration, so that intimacy conditions can be optimized by there
only being one door and a greater versatility in the use of the space is
achieved, which functionally ends up much more flexible in that manner.
The consultation should be big enough (useful area a minimum of 18
2
m ) for the doctor and necessary nursing personnel to fit, according to the
support requirements which result from each consultation modality, the
patient and, if the case may be, a person accompanying him.
Besides medical consultations, the possibility of including in this area
a nursing consultation, a room for curing, and information offices, is fore
seen, as long as they permit the more versatile use of the space and achieves
a better functional adaptation to the very characteristics of the activity in
each unit.
Patient toilets and dressing rooms
The patient dressing rooms are situated in a space next to the day hospital
posts. There will be differentiated between men and women and shall have
enough space for lockers, which permit the custody of clothes and personal
objects.They shall have restrooms for patients (including a shower), situat
ed next to the dressing room, provisioned similarly to public restrooms,
adapted for patients with reduced mobility and with a size adequate to the
unit.
188
Patients box
On occasions, the healthcare process will be structured so the patient has
direct access to the day hospital from the waiting room, without the need to
be attended to prior to the consultation, not necessarily implying that the
typical consultation actions be done away with (which in these cases can be
carried out in this post).
Besides, once the explorations, diagnosis and treatments have finished,
the patient can recuperate in the same place, or, if the procedures requires
specific support, be transferred, within the day hospital area, to an observa
tion post.
Finally, it shall be kept in mind that the post prepared for patient recu
peration can adopt diverse forms, using as a principle support treatment
chairs or beds, according to the very characteristics of each treatment. Con
fronted with a wide range of possible modalities, it is recommended to have
flexible, open structures which can adapt themselves with ease to changing
needs.
It is considered necessary at the same time, to have some closed rooms,
with restroom included, for cardio-version.
The day hospital posts will have oxygen and vacuum sockets and, beds
or treatment chairs, according to the needs, which can be regulated in
height, a small bed-stand with space for personal effects of the patient and
a wing for holding trays, as well as a space for an additional chair (to be used
by the person accompanying him in the case it be indicated). Each post will
have all the necessary electrical installation for lighting as well as the use of
electro-medical equipment whose use is required for administration of
treatment. It will also be valued as a convenience to have a television and,
in every case, will contain a unit for manual control by the patient, which
will permit advising nursing personnel, the handling of illumination and, if
the case may be, a remote control for the television.
It is of particular interest the location of windows. Whenever possible,
the patients shall remain under natural light and have a view to the outside,
as long as its compatible with the guarantee of the necessary intimacy when
treatment administration requires that the patient be undressed.
The day hospital posts can be set up, in accordance with the afore
mentioned, in common rooms or individual posts, according to the treat
ment characteristics. In common rooms each post shall occupy, at least, a
space of 3.0 x 3.0 metres, and shall enable convenient isolation through cur
tains or screens or, if the case may be, fixed wall panels. The common rooms
of the day hospital used by patients of both sexes have clear organizational
and economic advantages. It is essential, however, that they not affect the
conditions of intimacy and dignity in the administration of treatments.
189
The day hospital posts shall permit health personnel access to the
patient in the simplest manner possible. The standard treatments can
require negato-scopes (or in the installation of new floors with work sta
tions that permit the consultation of clinical documentation and radi
ographic images), exploration lamps, equipment for RCP (as a support con
fronted with eventual complications) and hand washing points.
Generally recuperation will take place in the same location in which
the exploration is performed. Nevertheless, it is possible that, in determined
cases, patient conditions permit the post to become free (to be occupied by
another patient), but discharge not yet be indicated. until they are attended
to after a while in the consultation or receive determined clinical informa
tion) or, a specific room can even be set up specifically destined to this end.
Patient rooms (with toilets)
In some cases, to determined patients and treatments, the use of individual
posts can be more appropriate. The requirements for said posts are, gener
ally, analogous to the day hospital posts in common rooms, necessarily hav
ing a restroom (sink, toilet and shower) for the exclusive use of each room.It
is recommended that the size of the room not be inferior to 3.50 x 4.00
metres (14 useful m2). The restroom should have an area less than 4.5 m2.
Nurse station
It contains the group of physical resources dedicated to the task of patient
observation while they recuperate from explorations and interventions
administered, care planning and other administrative nursing work, as well
as the necessary support for the healthcare to the unit (management and,
if the case may be, storage of pharmaceuticals, material, equipment, lin
gerie and food). This local shall be situated in the central area of the unit
(common room for day hospital posts) and with easy access to individual
posts and consultation area, with an open design to minimize distances
and facilitate the watching over and access to patients.The nurse station
post shall have a counter with a surface for writing, communication equip
ment, including central reception of calls to the nurse, space for storage of
work material and for clinical documentation. On newly created floors, the
installation of work stations with access to patient managerial applications
and clinical stations are recommended.
190
Clean closet
The day hospital area shall have a clean closet (for pharmacy preparation),
ready for the management of medication used and which shall be located
next to the nurse station. In this room the sterile material for the area will
be stored.
Fungible material storage room
Fungible material supplies deposit for the functioning of the area.
Meal closet
A small meal closet is considered necessary for the preparation of light
drinks and food during the recuperation of the patients.
Bedclothes storage room
Locale for the storage (normally in carts with periodical replacement) of
clean clothes.
Cleaning closet
Locale for the storage of cleaning tools and material.
Dirty closet and waste classification
Locale for the depositing of dirty clothes and with space for the advance
classification of waste. With a water source and tip.
Personnel rest and dressing room
Rest and dressing rooms for nursing personnel of the day hospital area.
Should include sink, toilet and shower.Personnel zone in this area different
physical resources are situated destined to the organization of medical work
of the different healthcare areas of the heart unit.
191
It is considered essential that this personnel zone be related to inter
nal circulation (bedded patients, personnel, supplies and services) of the
hospital and have easy access to different healthcare resources (CCU,
Emergency, Radio-diagnosis, Surgical Block, multi-service Hospitalization,
Rehabilitation, etc.) of the hospital.
The physical resources destined for the work of personnel (sessions,
reports, organization of the Unit, meetings, teaching and training, rest and
dressing room) shall be located integrally with the rest of the zones in the
Unit with the objective of sharing to a maximum physical resources, equip
ment and personnel, as well as maximum function integration to be made
possible. The size of the resources in this area of the Heart Unit will depend
on the level of integration of the different areas which are integrated in it.
Clinical office
The medical (and nursing supervision) offices will be provided with
ergonomic furniture, will guarantee privacy and will facilitate team work.
They will have telephone communications and access to the data network,
as well as work stations with access to the applications of the clinical station.
Medical work room / reports
Open room with work posts with voice and data communications and
with a small space for meetings.
192
Secretarial office
Administrative work post of the Heart Unit, with space for filing and a
reprography room.
Muti-service room (meetings / sessions / library)
Multi-service room with enough space for the holding of clinical sessions,
teaching, formation, residents, with equipment which permits the applica
tion of tele-medicine (video-conference, imaging connection to interven
tion, teaching rooms, etc.).
Personnel waiting room / refrigerated job
Locale for the resting of the personnel, equipped with a small space for the
conservation and preparation of light food and drinks. It includes having a
sink and a small storage space.
Personnel restroom and dressing rooms
Locales destined to rest and dressing rooms for professional in the cardio
logy area.
193
12. Quality
From an administrative viewpoint the authorization of the UAAC’s rests on
the hospital centre on which it depends.
There are not, in Spain, criteria for the accreditation of this type of units.
The UAAC’s cover, as described throughout this document of stan
dards and recommendations, a group of resources and units. Some of these
resources have been analyzed in other documents of standards and recom
mendation, which contain their respective quality indicators. The use of
those indicators, adapted to the situation of each assistance unit in the area
of the heart is recommended in relation to the surgical block6, the unit of
multi-pathology patients4, the unit of hospital emergencies9, conventional
hospitalization8, intensive care unit10.
In the chapters dedicated to each type of unit in which the UAAC has
been classified functionally, standards of functioning, production and per
formance, as well as volume and safety have been proposed, which can serve
as a basis to establish, for each one of these units, the quality indicators.
ECI-SNS indicators
The ECI-SNS has elaborated a group of indicators to monitor the achieve
ment of strategy objectives. Those which are specifically applicable to the
UAAC’are the use of arterial grafts in re-vascularized patients, he rate of re
interventions in re-vascularized patients, the intra-hospital mortality after
coronary angio-plasty (global, in patients with acute myocardial infarction,
patients without acute myocardial infarction), the hospital mortality after
coronary surgery.
The formula for the use of arterial grafts in re-vascularized patients is
(a / b)*100, a being, the number of re-vascularized patients with arterial
graft, in one year, and b, the total of patients re-vascularized through proce
dures which require the use of grafts, in this year. Including all those releas
es in which the procedural codes of international classification of illnesses
(CIE9, version 9-MC appear: Numerator: 36.15, 36.16, 36.17, 36.2; Denomi
nator: 36.03, 36.10 to 36.17, 36.2. Source: Register of hospitalization releases
(CMBD), MSPSI.
The formula of rate of re-interventions in re-vascularized patients is (a
/ b)*100, a being, the number of releases with coronary re-vascularization,
whether through angio-plasty or through coronary surgery, in patients who
have already been submitted to a re-vascularization, in a period of time
prior to the year and b, the Total of releases with re-vascularization proce
dures. This global indicator can be sub-divided, mainly, in two, keeping in
mind the type of initial procedures to which the patient was submitted. In
this manner, the following complementary indicators will be found: A) –
195
Percentage of releases in patients who, after having been submitted to an
angio-plasty, are newly re-vascularized in a period of one year (through
another angio-plasty or through surgical re-vascularization procedures), B)
– Percentage of releases in patients who, after having been submitted to a
surgical re-vascularization procedure, are newly re-vascularized in a period
of one year (through angio-plasty or through new surgery). The use codes of
the CIE9.MC, according to the case treated: A), B), or Global (sum of pre
vious codes and denominator in all indicators) are the following: -For the
angio-plasty 36.01, 36.02, 36.03, 26.05, 36.06 and 36.07 –Fpr the rest of the re
vascularizatons: 36.20, 36.17, 36.19, 36.2, 36.31, 36.32, 36.39, 36.91, 36.99.
Source: Register of hospitalization releases (CMBD), MSPSI.
The formula for Intra-hospital Mortality after a coronary angio-plasty
in patients without acute myocardial infarction is (a / b)*100, a being, the
number of people released from the hospital through death, after the per
formance of a coronary angio-plasty procedure; and b, the total of people
released after said procedure. The denominator includes, for the different
categories, the following international illness codes (CIE), version 9-MC:
36.01, 36.02, 36.03, 36.05, 36.07. The numerator adds to the previous codes
the Exitus criteria as a release motive. In the case of mortality after an
angio-plasty in patients with acute myocardial infarction, all cases in which,
besides the aforementioned procedures, infarction co-exists as a main diag
nosis (code 410 of the present version CIE9-MC) will be counted. Register
of hospitalization releases (CMBD), MSPSI. In this document the use of
EuroScore is recommended as a standardization method for results. The
rates of standardized mortality which are published in the United States and
the United Kingdom refer to the 30 days following the procedure.
The formula for hospital Mortality after coronary surgery is (a / b)*100, a
being, the number of patients deceased during their hospital stay, after being
submitted to coronary surgery, in one year, and b, the total of patients submit
ted to coronary surgery, in this year.The denominator includes all those releas
es in which the procedural codes, of the international classification of illnesses
(CIE), version 9-MC are stated: 36.10 -36.17, 36.19, 36.2, 36.31, 36.32, 36.39 –For
the numerator the criteria of release due to death will be added. Source: Reg
ister of hospitalization releases 8CMBD), MSPSI. Note: In this document the
use of EuroScore is recommended as a method of standardization of results.
The rates of standardized mortality which are published in the United States
and the United Kingdom refer to 30 days following the intervention.
Evaluation of the UAAC assistance network
The creation of assistance networks and the regionalization of services with
aspects repeatedly outstanding in this document of standards and recom
mendation, as well as in the ECI-SNS, is the reason why chart 12.1 contains
a questionnaire which permits the valuing of the network for the fulfilment
of managerial attributions.
196
197
Quality indicators for the integral emergency system
of the secast
Integrated in the objectives of the ECI-SNS, the quality indicators of the
integral system of emergencies for the attention of SECAEST permit the
evaluation of the work of the UAAC assistance network. In Attachment 2 a
proposal of structural, process and results indicators of the AHA is con
tained148 and in Attachment 4 the requirements for an ICP-P network.
The ESC has proposed the maximum delay time indicators for the
SCAEST network156 which are contained in Chart 12.2. The quality of med
ical attention, theadaptation of fibrinolitical treatment, delay times, and
clinical results should be quantified and compared at regular intervals for
the establishment of opportune improvement measures.
Quality indicators of the hemodynamics /
intervention laboratory
Besides the standards contained in chapter 8, Chart 12.3 contains the
indicators proposed by the AHA and the ACC51,53.
198
13. Revision and follow-up
criteria
It is recommended that a revision and actualization of this report be carried
out in a period not superior to three years. Throughout the debate process
for the elaboration of this report, gaps of knowledge, especially those in ref
erence to the availability of information and contrasted experience with the
functioning of the CCUs’s in the Spanish health system, have been identi
fied. To improve this knowledge as a basis upon which the recommenda
tions based on the evidence, or, at least, experience are elaborated, the fol
lowing is recommended:
– A systematic analysis of the CCUs indicators, which encompass the
group of indicators recommended in this report.
– Impulse the register of cardiac intervention, including cardiovascu
lar, to be mandatory.
– The publication, by hospital, of the volume and results of the inva
sive procedures, surgical as well as intervention (hemodynamics and
electrophysiology), using an adequate standardization method.
The regionalization of the UAAC’s, as well as the impulse for the cre
ation of assistance networks is recommended. The creation of networks for
PCI-p is a strategic objective for the improvement of the handling of the ST
elevation acute coronary syndrome.
The creation of the profession of health technician in cardiology imag
ing diagnosis is recommended.
The recommendations contained in this document shall serve, with the
collaboration of the SEC and the SCTCV, to orient those administrations
which have the obligation to create norms in said respect, with the objective
of homogenizing them in the different autonomous communities.
199
Annex 1. Groups related by
diagnosis (GRD) of the
cardiology area(76)
(76)
Source: http://www.msc.es/estadEstudios/estadisticas/cmbdhome.htm. Datos 2007. Own cre
ation.
201
202
Annex 2. Structural, process
and result indicators of the
emergency system for the
attention of patients with acute
coronary syndrome(77)
(77)
Peterson ED, Ohman EM, Brindis RG, Cohen DJ, Magid DJ. Development of Systems of
Care for ST-Elevation Myocardial Infarction Patients. Evaluation and Outcomes. Circulation.
2007;116:e64-e67. Consultado en:
http://circ.ahajournals.org/cgi/content/full/116/2/e73, el 14.11.09.
203
204
Annex 3. Treating the patient
with congestive heart failure(78)
The ICC is an serious illness and more and more frequent with a prevalence
in the general population of 3 – 20 /1.000 inhabitants(79),218. The majority are
elderly219. The incidence and prevalence of the illness increases with age, from
approximately 1% of people between 50 – 59 years of age up to 10% of peo
ple between 80 – 89 years of age. In Europe, according to a study carried out
in Scotland, the average age of a first hospital admission for this cause if 74
years of age220 and in the United States half of all patients over 65 years of age
who are admitted for ICC are above 80 years of age221. In Spain at least 2%
of patients over 40 years of age suffer from cardiac insufficiency (IC) and the
subjects over 60 – 70 years of ageXlVIII it reaches 6 – 10%222. This illness rep
resents the third cause of SNS hospital admissions, after childbirth and respi
ratory disorders, which have a weight of 1.8% of the total of releases and 2%
of the total of SNS hospital stays (average stay of 8.3 days)(80). The increase of
the prevalence of ICC can be due to, among other reasons, an increase of
news cases because of the progressive aging of the population, the greater sur
vival from acute myocardial infarction and hypertensive patients (two of the
principal causes of ICC) due to better treatments and care, and the improve
ment in the survival due to a greater efficiency of illness treatments
(inhibitors of the conversion of angio-tensina, beta-blockers)223,224.
The prevalence of congestive heart failure and its epidemiologic pro
file, related to elderly people who frequently have other illness (co-morbid
ity), dependence and fragility, and the need for integral, systematic manage
ment, based on adhering to clinical practice guides225, on an assistance net
work based on the close collaboration between primary attention and spe
cialized cardiologic assistance, as well as with other socio-sanitary and social
resources, justifies the development and implantation of a attention unit for
the congestive heart failure patient.
The unit for patient treatment with advanced congestive heart failure
(heart failure unit, HFU) offers multidisciplinary care to this type of patient,
in various assistance modalities (hospitalization and day-care units), which
allows guaranteeing assistance at the most adequate moment and place, ful
filling functional and organizational requirements, which guarantee quality,
(78)
Adapted from: Unidad de pacientes pluripatológicos. Estándares y recomendaciones. AC
SNS, MSPS 2009.
(79)
The epidemiology introduction is based on Quintana and cols. 2008.
(80)
Source: GRD databases Own creation. It was considered the GRD, 127 Heart failure and
shock. It does not contain the secondary CHF diagnosis but other main diagnoses.
205
safety and efficiency in this activity. The heart failure unit is made up of a
cardiologist and nursing and auxiliary personnel, linked to primary atten
tion professionals for the systematic attention to the patient.
Criteria for patient selection
The approximation of Kaiser Permanente, adopted by the Health Depart
ment of the United Kingdom, for the management of the population with
chronic illnesses26,227, identifies three groups of chronic patients in relation
to the grade of complexity. As can be observed in figure A 3.1, adapted to
the Health Department of the United Kingdom, the population with chron
ic illnesses can be placed in three levels of complexity.
In level 1 we can find the majority of the population with chronic ill
nesses, which can benefit from healthcare programmes of the field of pri
mary healthcare, paying special attention to health education and promot
ing self-care.In level 2 those chronic patients with an illness to a specific
organ playing an unquestionable leading role, can benefit from disease
management programme228.
In level 3, those patients with very complex needs which require a spe
cific organizational infrastructure which provides highly personalized serv
ice, can be found.
Figura A 3.1. Ranking of chronic patients(81)
(81)
Adapted from: Improving Chronic Disease Management. Department of Health. 3 March
2004.
206
The heart failure unit attends to, in close collaboration with primary
healthcare health care, those patients of levels 2 and 3 of complexity when
they are de-stabilizedlVI, due to which patients with congestive heart fail
ure in stages C and D of the ACC/AHA229 or with de-compensated cardiac
insufficiency, meet this criteria230.
The HFU can act as a consultant of the UPP since it is nor in-frequent
that patient with congestive heart failure have other types of pathology
associated, whose integral management can be carried out from the UPP.
The type of unit which is most adequate for the clinical management of the
chronic patient with congestive heart failure, shall be carefully valued.
Joint Healthcare Plan (JHP)
The model of shared healthcare to the patient with congestive heart failure
between primary healthcare and the heart failure unit can be denominated
group healthcare plan (JHP). The identification of the patient, in the hospi
tal information system as well as clinical record, is fundamentally for the
coordination of the actions of the heart failure unit with other hospital units.
The JHP will be activated with the person responsible for the patient
in primary healthcare and the person responsible for the heart failure unit
consider, mutually, that the patients needs the group intervention of both of
them for his clinical control. Activation of the JHP will be formalized
through a witnessed consultation in the day unit of the heart failure unit or
through hospital admission.
It is important to point out that patients who attended to in the heart
failure unit shall be done so in coordination with their doctor / nurse from
primary healthcare, who maintains the guardianship of the patient. Hospital
admission will be programmed through the primary healthcare doctor in
contact with the heart failure unit, being the objective the avoidance, when
ever possible, of the patient resorting to hospital emergency services.
During any episode of hospital admission of the patient, in beds not
assigned to the heart failure unit, the person responsible for that unit will be
advised for his valuation, with independence of the reason and unit or serv
ice where it is carried out, after which the collaboration with the correspon
ding specialist of the unit, where the patient has been admitted, will be
decided, the appropriateness of follow-up from the heart failure unit, or not,
during hospital admission.
In a Spanish study a greater adherence to protocols and use of
resources was shown when the patient was admitted to a cardiology service
rather than when he was treated in internal medicine rooms, without there
being difference in early mortality231.
207
The rehabilitation and physiotherapy units shall collaborate closely
with the heart failure unit in the functional recuperation of the patient,
especially in the ambulatory field. An early planning of hospital discharge232
for the hospitalized patients with congestive heart failure, evaluating the
early care needs of the patient, family and surroundings will be carried out.
At the time of hospital discharge, a report on care continuity which covers
the level of dependence and active problems, will be carried out, in which
the telephone and name of the heart failure unit nurse will appear, and will
be given to the patient and be directed to the primary healthcare field nurse
and, whenever necessary, to the community liaison nurse or case manager.
In patients with activated JHP, all consultations to different units or
medical services and the activation of hospital support systems (hospitaliza
tion at home, for example) will be carried out through the person responsi
ble for the heart failure unit.
The person responsible for the heart failure unit and the reference nurse
of the same will be ready to comment on treatments and changes in the care
plans with the responsible doctor and nurse in the field of primary health
care.The activation of different home support systems will be carried out in
agreement between primary medical healthcare and the heart failure unit.
The characteristics of being chronic and progress of patients with con
gestive heart failure gives a patient followed in the heart failure unit the
possibility of being included in other programs(for example, palliative care),
which can cause healthcare duplicity. In the case of those programs assum
ing the integral healthcare to the patient, the JHP of the heart failure unit
will be inactivated.
Services portfolio
The CCUs-heart failure unit can have various levels of deployment of the
service roster.
The pathologies which it attends to, listed by the GRD, for example. It
is recommended that the reference unit for all stable cardiac pathology in a
determined population be the heart failure unit.The healthcare modalities
which are offered in the unit. Every heart failure unit shall offer health
healthcare to the patient with congestive heart failure in the conventional
hospitalization unit and, in ambulatory form, in external consultations and
in the day hospital (Hd) or in the multi-service DCH.
The procedures which are carried out.The amplitude and conditions of
the services roster will be according to the organization of each hospital, the
size of the heart failure unit and the resources available, the organization
and management of the same and the reference population.
208
It is recommended that the heart failure unit be organized to offer
healthcare coverage to the patient with congestive heart failure on work
days as well as holidays, which will permit the reduction in the use of emer
gencies and improve the management of patients in the conventional hos
pitalization unit. The heart failure unit shall define the hourly schedule of
healthcare to patients with congestive heart failure, identifying the schedule
corresponding to holidays, as far as ambulatory activity in the day unit is
concerned as well as the accessibility schedule of the professionals of the
heart failure unit, directed to the very patients, the emergency unit or serv
ice and the primary healthcare professionals linked to the unit.
It is recommended that the heart failure unit be coordinated with
home hospitalization devices and palliative care. Besides this, the heart fail
ure unit can be supported by other types of resources, especially in units for
half stay or recuperation, and other devices such as home physiotherapy for
the healthcare to the patient with congestive heart failure.The heart failure
unit shall have multi-service hospital beds for acute patients.
Circuits
In collaboration with primary healthcare, circuits shall be elaborated for the
programmed of direct emergency and programmed admissions, as well as
for the programmed of procedures after hospital discharge. Special consid
eration shall be taken to:
– Define circuits to guarantee emergency preferential specialized
healthcare, without having to go through the emergency service.
– Facilitate primary healthcare doctor and nurse hospital visits to the
patient with a prolonged stay.
– Avoid merely bureaucratic referrals, appointments and revisions, as
well as revisions in the stable phase and appointments to set up explo
rations, deliver reports or make out prescriptions. Shared clinical
information can resolve the immense majority of those procedures.
General links in the relationship which contribute to
unifying the concept of the integral health and vision
of the patient
– Facilitate the recycling of the primary healthcare doctor in the heart
failure unit linked to group programs.
209
– Develop the lines of clinical investigation, which shall contribute to
evaluate global life quality of the patient and not only specific
physio-pathological or clinical aspects.
– Collaborating in the drafting of medical practice guides based on
evidence.
– Propose teaching activities included in doctoral courses, seminars
and workshops, with the teaching intervention of the heart failure
unit and primary healthcare.
– Spread collaboration experiences and show the results obtained in
the healthcare to patients with congestive heart failure, going deeply
into health and sanitary care concepts for the advancement in the
development of an integral and continuous healthcare model.
– Create work groups on specific topics such as teaching, investiga
tion, register and computerizing, pharmaceutical expense, therapeu
tic formulation of the area, etc...
Relationship between the heart failure unit and the
hospital emergency service
The relationship between the heart failure unit and the emergency service
has as its main objective to avoid the inadequate use of the same by the
patient with congestive heart failure and, whenever possible, minimize the
healthcare episodes in said service when the patient suffers from re-acute
ness. For this reason, the following circuits, among others, can be contem
plated:
– Patient remitted to the heart failure unit from the emergency serv
ice for preferential study and close control (first visit). The main
characteristic of those patients will be that which, in other circum
stances, they would be admitted.
– Patient chronically symptomatic with partial improvement in the
emergency service but who requires a close control to avoid return
ing to the same.
– To acquire patients who periodically need certain procedures.The
patient with activated JHP will be attended to in the emergency
service in the hours when there is no coverage by the heart failure
unit, from which the discharge will be decided, day unit healthcare
or the admission of the patient in a conventional hospitalization bed
assigned to the heart failure unit.
210
In said case, inadequate admissions shall be avoided to acute hospital
ization beds and preference given to the admission to the heart failure unit
of the patient attended to by primary healthcare doctors who cooperate
with the unit.The relationship between the heart failure unit and the emer
gency service of the hospital shall tend towards generating links which contribute to the unification of the integral health and vision concept of the
patient, through periodical sessions for the common groundwork of patients
sent, the results (diagnostic and therapeutic) obtained and the proposition
of group work to improve patient healthcare (avoid unnecessary admis
sions, to advance studies, avoid consultations to the emergency service for
close clinical – analytical controls) through group action protocols.
Relationship of the heart failure unit with social and
socio-sanitary services
The relationship of the heart failure unit with primary healthcare shall be
complemented with the development of coordination mechanisms for both
with social and socio-sanitary resources available. This need is motivated by
the close relationship between fragility and dependence, as well as the evo
lution of those patients.
The coordination between the heart failure unit and socio-sanitary and
social resources has special relevance to early discharge planning when the
patient is hospitalized233. Also to offer the patient the precise support which
avoids, among other benefits, the inadequate admissions to general hospitals
of acute patients and situations of over-burdening of the caretaker and even
therapeutic abandonment.
In the lst Conference of prevention and health promotion in clinical
practice in Spain, for the prevention of dependency in the elderly234 the pro
vision of units for sub-acute patients (unit s for half stay / recuperation) for
patients with Ictus, hip fractures and elderly patients who, once stabilized in
the acute phase of their illness, present functional deterioration to their
basal situation, subsidiary to recuperation. The relationship between the
heart failure unit and the sub-acute units is recommended to guarantee
early rehabilitation to the patient with congestive heart failure, with the
objective of reducing dependency. These units can be in the same hospital
for acute patients where the heart failure unit is situated or in its proximity.
The clinical practice guide for palliative care235 recommends that
«health organizations and healthcare services shall guarantee the coordina
tion between the different services and healthcare fields and the continuity
of care, during 24 hours a day, 365 days of the year».
211
The coordination with social-services will be based on an evaluation of
needs presented by the patient and his family environment, from the most
basic to others such as relationships or free time, and can include support
ranging from patient hygiene and home cleaning, day centres, tele-health
care services, to room and board, in a regimen of admission or day health
care, training in personal autonomy and psycho-social rehabilitation and
socio-work integration. Social services also offer family support, re-adapta
tion to the community environment, and workshops for socio-cultural ani
mation services. In this field there are experiences in some autonomous
communities based on liaison nursing or case management which serve as
reference elements, coordination and management of necessary care, or
through the support of social workers.
The heart failure unit shall have, or have access to, professionals (com
munity liaison nurse / case manager and/or social worker) who facilitate the
coordination of health, socio-sanitary and social and continuous care
resources.
Organization and operation of the heart failure unit
The description of the organization of the heart failure unit is articulated in
relation to the process of healthcare to the patient.
Throughout the follow-up of the handling of the patient in the sur
roundings and within the heart failure unit, organizational and management
alternatives are given. Each health organization shall give priority to the
alternatives most adequate for its organizational and management system.
In accordance to the needs derived from the integrated patient health
care process included in a heart failure unit program, the requirements con
tained in the following graph are indispensable.
212
All patient with congestive heart failure and who fulfils the criteria for
inclusion to the unit shall have easy access. Coordination of the heart fail
ure unit with primary healthcare, which has an essential role for the
acquisition, as well as follow-up, of patients with congestive heart failure.
The unnecessary admission of patients to the conventional hospitaliza
tion unit shall be avoided.
The coordination of the UICC with the hospital emergency service is
necessary to reduce the unnecessary hospitalization.
The functioning and programming schedule of the day unit which
reduces the admission to the conventional hospitalization unit.
The availability of beds in conventional hospitalization, day hospital
resources and consultation locales.
To have or be able to coordinate with home hospitalization, palliative
care and half stay / recuperation resources, as well as social resources. To
develop and use new information technologies to serve as a support for
coordination between primary / emergency services and the heart failure
unit, as well as to avoid trips for patients (managements agendas), or the
repetition of complementary tests (shared records), etc.
The discharge reports of the heart failure unit shall contain an action plan
with reference to clinical therapeutic and follow-up objectives, especially
in the circumstances in which co-morbidity or prognosis advise the indi
vidualization of therapeutic objectives for chronic illness which the
patient suffers from.
Management of the heart failure unit
The heart failure unit will be integrated in the hospital cardiology area /
health area / multi-hospital system. In the supposed case that the hospital
does not have diagnostic imaging, intervention or cardiovascular surgery
needed for diagnosis or treatment of patients with congestive heart failure
attended to by the unit, it will insert an healthcare network which will provide for those resources, establishing protocols for indication, referral and
return to the unit.
213
Annex 4. Requirements for a
Primary Percutaneous Coronary
Intervention system (PCI-p)
General requirements
– Communication network. The hospitals with an PCI-p program shall
have an operative, integrated communications network. The com
munication aspects shall include a sole alert number for the medical
emergency system and a sole number for the activation of the PCIp mechanism at hospital level. The operative aspects of the network
will include the procedure for the election of the centre with an PCIp to which they patient with IAM will be taken.
– Local multidisciplinary program. Each centre shall have a multidis
ciplinary program which includes emergency services (including
nursing), intensive care unit (general or cardiovascular), clinical car
diology and intervention cardiology. Said program shall be coordi
nated with the emergency doctor service and be in consensus with
the cardiac surgery service. The program shall establish the patient
circuit, the activation and internal communications to get re-perfu
sion in the shortest time possible.
– Patient circuit. The units integrated in the PCI-p network shall con
crete a circuit which the patient shall follow in the hospital. The
going through admissions or other services which prolong arrival
time to the hemodynamics room shall be avoided.
– Data collection. To maintain an PCI-p program successfully data
with reference to clinical results and times shall be collected in a
prospective and systematic manner. This will permit having statistics
on healthcare work, the detection of errors in the system, the elabo
ration of modifications to the same and proportion quality indica
tors. The amount of information collected shall be as little as possi
ble and permit the fulfilment of the previously mentioned objecti
ves. The analysis of clinical as well as operative results shall be plan
ned, carried out in a periodical manner and communicated to all
those involved.
– Equipment / apparatus of a hemodynamics room which performs pPCI. The hemodynamics room which forms a part of this p-PCI net-
215
work, shall have, besides normal equipment, respirators, a console of
contra-pulsation intra-aortic balloon, electro-catheters, external
generators for pacemakers and all the material of a reanimation cart
needed to be able to perform advanced reanimation techniques in
the context of a patient with IAM and its possible complications..
Integrants of the on-call PCI-p Team
The hemodynamics service which forms a part of the PCI-p network, shall
have in its totality, a 7x24x365 (7 days a week, 24 hrs. x day, 365 days a year)
on-call service. The on-call team will be formed by hemodynamics and nurs
ing personnel.
1. Hemodynamics personnel. The team for PCI-p shall be integrated
by, at least, 4 hemodynamics specialists with advanced training in
intervention cardiology. To decide on the number, the capacity for
covering the on-call duties and the maintenance of daily activity
shall be kept in mind.
2. Nursing personnel. It is necessary to have two nurses familiarized
with direct assistance to the procedure and sufficient (autonomy)
knowledge of the material. Although it is convenient to count on
the presence of an additional technician, this person cannot substi
tute nursing in the clinical work of critical patient healthcare or as
assistants to the intervention.
3. Additional medical personnel. It is important that, confronted with
the performance of an emergency procedure, the on-call doctor in
the critical area (unit of general intensive or cardiovascular care) be
informed. Although it is not indispensable, the physical presence of
the on-call cardiologist for the possibility of any serious intra-pro
cedural eventuality (ventricular fibrillation, acute lung oedema,
need for ventricular healthcare, etc.), is ideal.
Qualification of the hemodynamics specialist
To be able to form a part of the PCI-p team, a cardiologist with advanced
training in hemodynamics and intervention, requiring he be autonomous to
develop the fundamental techniques for coronary intervention treatment.
Besides this, it is considered that, to obtain and maintain an adequate capa
city in the treatment of IAM, the performance of, at least, 30 PCI-p a year,
is necessary.
216
Qualification of the PCI-p centre
Any of the centres which form a part of the PCI-p network shall perform,
at least, > 500 procedures a year, and, at least, a volume of > 50 PCI-p a year.
Requirements of the PCI-p program
For the PCI-p program to function adequately it shall form a part of the
Global Program of Re-perfusion in the IAM, integrated in the public health
system. It shall be promoted and publicized and guaranteed by the health
system.The re-perfusion program shall be multi-disciplinary, designed and
developed in a group manner between emergency systems, critical care doc
tors and hemodynamics specialists, with the participation of emergency doc
tors and nurses and on-call cardiology. This multidisciplinary team shall fix
the circuit which the patient shall follow once the diagnosis of IAM is made.
All of this will lead towards a reduction and optimization of times for the
re-perfusion of patients in the context of an IAM.
The two pillars which guarantee the sustention of the program are the
collection and periodical analysis of involved global and unit results, and the
priority and incentive of its development. The optimum volume of PCI-p
ranges between 400-600 / million inhabitants. In Spain, taken from the regis
tration data of hemodynamics activity, the autonomous communities with
structured programs are performing between 330-430 PCI-p / million inhab
itants. An objective, for constituted networks, can be to achieve at least 70%
of PCI-p in patients with IAM. This objective shall be revised in accordance
to the conditions of accessibility (population and geographic) to the pro
gram, the capacity to be more ambitious in a large nucleus of population
and less in disperse areas.
PCI-P Program in the context of a global
re-perfusion program
Keeping in mind the extension and dispersion of the population in Spain, it
is necessary to integrate the PCI-p program in a global re-perfusion pro
gram in each community, proposing the possibility of using as a first meas
ure for treatment of IAM to the PCI-p, instead of the use of fibrinolitics
followed by a pharma-mechanical strategy. The decision for the mode of re
perfusion shall be based on efficiency and availability of PCI-p criteria, in
217
an adequate time and manner. It is good to make sectors out of a territory
to, create treatment algorithms and define the place where the patient shall
be referred to.
To evaluate the actual making of sectors it is necessary to monitor the
times up to effective treatment. This information shall be spread so that the
hospital without an PCI-p develop its own treatment algorithm.
The recommended times for the ECI-SNS11,12:
• Primary angioplasty in at lest 90 minutes (door-balloon time).
• Time for revascularization with fibrinolitics in less than 30 minutes
(time door-needle) or 90 minutes (time call-needle).
The emergency system develops a central role since, according to
experience in different communities in Spain (Murica, Navarra, Galicia,
Balearic Islands and Cataluña), in the majority of the cases it is one which
makes the first medical contact with the patient, in his home as well on a
public street, and who activates the program, without delay, and transfer the
patient according to times foreseen to the corresponding reference centre
or proposes an early pharma-invasive strategy. That is to say, it holds the key
to the program.
218
Annex 5. Phases of the
prevention programmes and
cardiac rehabilitation(82)
PHASE I: HOSPITALIZATION: includes the period covered during hos
pitalization, up to discharge, with interventions in the intensive coronary
care unit as well as in the hospitalization room.
Figure A.5.1. Phase I: Hospital
PHASE II: AMBULATORY. Is the convalescence phase which is initiated
after the patient’s discharge and constitutes the period when the most
intense activities are carried out from all aspects which will determine the
changes to new life habits of the patient, lasting approximately between 3 to
6 months.
(82)
This annex has been elaborated with the contributions of Virginia Argibay.
219
Figure A.5.2. Phase II: Ambulatory
PHASE III OR MAINTENANCE: It covers the rest of the patient’s life,
and has as a main objective the maintenance of healthy habits, risk factors
control, habitual practice of physical activity and reincorporation to socio
work reality.
Figure A.5.3. Phase III: Maintenance
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Annex 6. Collaboration
agreement between the SEC
and the SERAM in the area of
cardiology diagnostic imaging(83)
Aiming towards promoting a better healthcare to patients, present Medici
ne, is oriented more and more to processes, in which the collaboration
among specialists or different origin and training is required. Due to the
multidisciplinary character of the medical practice, Scientific Societies try to
guarantee better conditions for the training and development of the profes
sional exercise of the specialists which they represent, they see in the colla
boration of other Societies an opportunity to promote a greater quality
healthcare for the patient, promote the acquisition of knowledge and deve
lopment of investigation, and at the same time that protect the interests of
their associates in the most efficient manner. In the same direction of the
collaboration trajectory which has been initiated in other areas by the Spa
nish Society of Cardiology (SEC) and which has permitted the establis
hment of collaboration agreements with other Scientific Societies in our
country, such as the SEN (Spanish Society of Neurology), the SED (Spanish
Society of Diabetes) or the SEEN (Spanish Society of Endocrinology and
Nutrition) and by the Spanish Society of Medical Radiology (SERAM),
with collaboration agreements with the SEMN (Spanish Society of Nuclear
Medicine) and the SEPAR (Spanish Society of Pneumology and Thoracic
Surgery) the 22/03/2010.
A framework agreement was signed between the SEC and the
SERAM in which the coordinated action between both societies was signed
with numerous points of convergence and areas of mutual interest.The main
goals of this SEC-SERAM framework agreement are identifying areas of
mutual interest to boost actions aimed at the collaboration of both societies
in order to improve patient healthcare, which is the crux of all the actions in
the following collaboration scenarios: healthcare field, quality control, tea
ching and training of professionals in the field of cardiac imaging, research
(83)
Sociedad Española de Cardiología (SEC) y Sociedad de Radiología Médica (SERAM).
Comisión de Trabajo Paritaria. Acta y Propuestas de colaboración (Valencia, 22 de octubre de
2010).
221
and defence of professional and working interests of their partners, and all
this in accordance with the current legislation and ethical principles of the
practice of medicine.
In accordance with the framework agreement, of 16th of April 2010,
the first joint work commission composed of members of the SERAM and
the SEC met at the House of the Heart in Madrid, with the aim of drafting
a document of minimum standards in which healthcare, quality, training and
joint research are considered.
The members of this commission ratified the will of both societies to
collaborate, due to considering that:
1) The collaboration is a reality already present, in some cases from
years ago, in the daily healthcare practice of many Spanish centres, some of
which are excellent, in which the cardiac imaging techniques are indicated,
performed, interpreted and informed by, or under the supervision of teams
made up of cardiologists and radiologists. This transversal model, where
units of diagnostics specialists from different places participate in the same,
each one with his competencies, very extended in other countries around
ours, permits results in terms of resource use, safety and diagnostic per
formance which could be superior to that of the traditional concept of iso
lated departments.
2) This model of collaboration among specialists in healthcare, tea
ching and investigation activities can revert to a better training of experts in
the field of cardiac imaging whose demand, in our country, is foreseen to be
increasing the following years.
3) The shared use of diagnostic therapy for cardiac pathology Image
and the knowledge of the different professionals, radiologists and cardiolo
gists, involved in the indication, selection, execution, interpretation and
report of each type of test, could turn out to be beneficial for patients, spe
cialists and for society in general.
4) The new model of collaboration in diagnostic cardiac imaging could
turn out to be more rational, by permitting the improvement of indications
for each exploration, the performance of its interpretation and safety, by
choosing the most ideal candidates or the most adequate technique and
being able to attend better to possible complications. Working in a group
form, radiologists and cardiologists make the consensus and optimizing of
action protocols possible for each pathology to be studied with the objecti
ve of avoiding duplicity of explorations, reducing with it risk, unnecessary
expenses and bother to the patient, as well as making the proportion of non
conclusive test reduce, with the consequent improvement in the use of
resources.
The essential objective of this committee was the identification of
common areas of interest so that, afterwards, if both societies agree, work
222
groups are created, with equal representation of members proposed by each
Society, who take care of concrete topics which can result in joint action
documents in manner, for example, of recommendations, clinical practice
guides, etc. which can be guaranteed by both Societies and published in their
respective magazines. Also, these work groups could propose some specific
actions which permit the setting up of teaching projects and common inves
tigation in the field of cardiac imaging.
The joint topics of interest identified by this commission whose appro
ach could be initiated through concrete actions were:
1) Functioning of cardiac imagery units. Present state of the cardiac
imagery techniques in Spain, The concrete proposal: amount of different
types of cardiac imagery studies which are performed, provision of equip
ment and its state (type, age, and conditions of use), provision of personnel,
hours dedicated, joint units, and other aspects which permit having the
objective data with which to work. Indications of appropriate use of cardiac
imagery techniques. Create a committee of experts to evaluate the appro
priate use of cardiac imagery techniques in our field, with the capacity, if
necessary, to establish specific recommendations, in the line of criteria esta
blished by other societies and work groups.
2) Formation in cardiac imagery. With a periodicity, at least annually,
promoted and jointly organized by the SEC and SERAM. The concrete pro
posal to the advisory council of the SEC and to the directive board of the
SERAM to hold throughout the year 2011 the first Joint Course of Cardiac
Imagery between the SEC-Section of cardiac imagery and the SERAM-sec
tion SEICAT (Spanish Society of Cardiothoracic Imagery) in which the
main technology companies of the Sector are involved. To establish requi
rements for the training of residents in both Imagery specialties and promote agreements for permeability of rotations between the radiology and
cardiology departments, or multidisciplinary cardiac units in those cases in
which they exist, to specialists in training. Promote more scholarships and
aid for advanced training of experts in cardiac imagery in prestigious natio
nal and foreign centres.
3) Joint investigation programs. Creation of scholarships and aid. Con
crete proposal: To speak with the advisory council of the SEC and its equi
valent SERAM to promote the creation of new scholarships or aid, whene
ver possible sponsored by the industry which promotes investigation proj
ects in which the collaboration of radiology/cardiology exists.
Since the objective of this Committee was to identify areas in which to
advance rapidly, projects have been prioritized whose execution can be
initiated in brief and with ample consensus. Other topics, no less important,
related to healthcare, relative to how to promote cardiac imagery units, acti
vities of scientific and technical cooperation, teaching, the requirements for
223
professional training, quality control, accreditation, technical requirements,
etc. shall be treated in greater depth in future meetings, by the committees
of experts which are considered to be the most appropriate.
224
Annex 7. Office of
hemodynamics and intervention(84)
The proximity of the office to the area of conventional hospitalization, the
critical care unit and the cardiac surgery operating room, is desirable, espe
cially to these last tow. There shall be a space for the use of transportable
devices (monitor-defibrillator, special gurney for intra-aortic balloon, etc.,
which provide safety in transport).
It is highly desirable that, in those cases, the intervention room be
designed for its immediate adaptation as an operating room.Although for the
immense majority of cardiology intervention procedures a series measures of
asepsis of a general character are enough, the evolution of intervention makes
it advisable that certain procedures be carried out in conditions of sterility.
The reason is the progressive increase in the implantation of volumi
nous devices (in structural cardio-pathology) and the calibre of said devices
which occasionally require vascular repair techniques. Without trying to
transform all the laboratory into a hybrid state, and its location necessarily
being in the are of the operating rooms, a reasonable grade of sterility can
be obtained through a series of requirements such as the adaptation of air
through filters, the number of replacements of air per unit of time necessary
and the existence of positive pressure in the system.
At the same time the laboratory shall be able to be isolated from the cir
culation of people and material during the procedure which entails most risk(85).
Size, design, distribution of space and structure
It is accepted that the minimum size of 200 m2 for radiology equipment, with
an exploration room with basic radiology installation and the requirements
which are listed as follows:
(84)
Adapted from the contributions, given for this document on standards and recommenda
tions, by Javier Goicolea, updating the SEC's guide. Morís de la Tassa C (Coord.), Cequier AR,
Moreu J, Pérez H, Aguirre JM. Guías de práctica clínica de la Sociedad Española de Cardiolo
gía sobre requerimientos y equipamiento en hemodinámica y cardiología intervencionista. Rev
Esp Cardiol 2001; 54: 741-750.
(85)
See at: Bloque Quirúrgico. Estándares y recomendaciones. AC-SNS. 2010. 7.2.3.. Sistemas de
climatización en quirófanos. La climatización del gabinete de hemodinámica debe cumplir los
requisitos de un quirófano tipo B.
225
The minimum area of the hemodynamics room shall adapt to the spec
ifications of each radiology model, assuring the perfect mobility around the
work area keeping in mind reanimation and vital support material and the
additional possibility of incorporating elements, more or less voluminous, in
case of emergency, as well as a console of contra pulsation intra-aortic bal
loon. The minimum area acceptable is around 50 m2. The design of the space
should be rectangular with the relation to sides of 1.25/1. In chart 8.3. crite
ria for recommended exclusion by the ACC are gathered.
The area where work is carried out shall be built with a complete lead
shield and have medium conditions of sterility. There shall be air-condition-
226
ing to maintain a work temperature of about 19-20º. The height of the room
will depend on the type or arch which is acquired. As a norm it shall have a
height not interior to 3 metres. This can be a limitation at the time of choos
ing the type of arch and commercial company. The equipment with ceiling
suspension can require a superior height which shall be specified by the
commercial firm. It shall have a space for the work area where the arch,
table, monitors, stop cart, most frequently used material, defibrillator, per
fusion pumps, assistant table, medication and contrast cupboard go.The
installations will be those which correspond to an operating room with type
B. Amongst them:
– Central provision of oxygen, vacuum and compressed air.
– Provision of electrical sockets in a sufficient number to assure the
simultaneous functioning of all the necessary peripheral elements.
– It is mandatory that all power sockets of the radiological system and
the polygraph be independent to each other and any other hospital
device. The internal channelling of both equipments lines shall be, at
the same time, independent and be provided with the due isolation.
The control room, where part of the personnel remain and monitors,
general controls and the polygraph are located shall have an area of about
10-15 m2, be alongside it, in direct communication with the interior of the
hemdynamics room through a megaphone system and there be visibility
through a lead glass window, ideally parallel to the longest side, but can vary
according to available space.
Equipment room, refrigerated annex for transformers, generators and
central digitalization system unit. It shall be isolated (radiogenic compo
nents) but next to the exploration room, respecting the distance which the
specifications of the equipment determines concerning the length of
cabling. It is mandatory that it be an annex and separated, with independent
refrigeration, avoiding noises and maintaining a temperature low enough
for the correct functioning of the different machines.
Day hospital / recuperation, area of reception and surveillance next to
the intervention unit, whose size will depend on the activity of the unit. It
shall have enough electrical sockets and oxygen, vacuum and compressed
sockets. In this room patients are placed waiting for catheterization coming
from hospitalization areas,; after catheterizations, for arterial (compression)
access surveillance and clinical observation until their transfer to the area of
hospitalization, another hospital or their home in case an ambulatory pro
gram exists.
Area of interpretation and offices, which includes, at least, an individ
ual office for the person responsible for the intervention unit, and an open
space where a conference table and as many independent work modules as
227
medical personnel assigned to the unit can be situated. In these rooms there
will be situated the computers which serve as work stations, for the surveil
lance of studies, filling out of databases and elaboration of reports.
Support for personnel, such as the rest area, dressing and rest rooms
for both sexes.
Hemodynamics equipment
In new creation laboratories, the radiological chain shall necessarily
include the following elements:
– Generator.
– X-Ray tube.
– Flat image detector.
– MonitorsImage digital register systems.
– Arch deviceExploration table.
– Automatic injector.
– Protection system against ionized radiation.
This equipment demands a mandatory annual control and mainte
nance. The provision of a technical team, near in time and space, is very
important, to avoid problems derived from failures in the equipment which
can be important for the patient.
The following basic components of these elements and minimums
demanded for each one of them, as well as some non-essential components
of the equipment like surgical ceiling light and technical equipment for
intra-coronary diagnosis are described.
Conditions of the generator
– X-Ray generator to converter of frequency (multi-pulse) and con
trolled by a microprocessor.
– Digitalized presentation of automatic stabilization of network volt
age fluctuations.
– Equipped with automatic stabilization system for the power supply
voltage fluctuations.
– It will be valued that it provide solutions to avoid the interruption of
the functioning of the unit in the case of said fluctuations.
– Minimum power of 65 Mw. A greater power is valued.
– Low curling factor.
228
– Minimum time of exposition not superior to 1 ms.
– The margin of error of the Kvp.mA and time will be inferior to the
+/-5%.Automatic exposition control. Be prepared to work in con
tinuous fluoroscope and digital pulsation and digital cinema mode.
– Will have control and safety devices to protect the tube against over
load.
– Digital indicator which reports, in actual time, the situation of the
tube as far as the level of load.
– Control of fluoroscope use. The control of the fluoroscope time will
be through a digital surveillance system in the exploration module
incorporate in the support for TV monitors.
– It will have dose reduction techniques. High frequency (desirable).
Digital fluoroscope time control (desirable). Anatomical program
ming (desirable).
– Indication of total dose received by the patient (desirable).
Conditions of the X-Ray tube
– Gyrating anode.
– Double focus, with sizes not superior to 0.6 mm. and 1.0 mm in fine
and thick focuses respectively.
– Apt for a minimum tension of 125 Kvp.
– Minimum power of 80 Kw in thick focus. The power of each focus
will be valued.
– Thermal capacity of the anode not inferior to 1.200.000 UC.
– The total filtration of the group will not be inferior to 2.5 mm to 80
Kvp.Multi-flat X Ray collimator with manual and automatic func
tioning.
– It will have a virtual collimator device.
– It will have a rectangular diaphragm, besides valuing a system of
semi-transparent filtration and wedges.
– Specify characteristics and other possible forms of diaphragming.
The system of dose measurement through a flat/parallel ionization
camera incorporated integrally in the collimation system which per
mits the continuous evaluation of the dose/area product. It will
incorporate an automatic register system.
– The presentation will be digitally carried out in actual time in the
module situated in the ceiling support of TV monitors. The system
will be provided calibrated along with the consequent certificate of
camera/electrometer calibrationIt will have a program which per-
229
mits the emission of report in which data of information relevant to
the study is collected (type of study, patient data, radiographic and
technical parameter series as well as dose received, etc.).
– Anode temperature control system (advisable).
– Functioning with dose reduction techniques (advisable).
Flat detector
– Imagery system based on flat panel.
– Flat detector of at least 17x17 cm.
– At least three vision fields.
– Anti-collision system integrated in the detector casing.
– It will allow acquisition matrix of 1024x1024.
– Capacity to acquire up to 25 images per second. Ease in grille with
drawal.
– Upon the flat panel choice, it shall be considered: higher quantum
detention rate; higher space resolution; smaller photodiode size.
Conditions of the monitors
– They shall be high resolution with automatic commutation of 625 to
1.249 lines.
– The number of counted disconnecting ant type of «text» monitors.
– A minimum of 3 conventional monitors shall be demanded.
– Two monitors, one of them designed for actual time imaging and the
other for the treatment of previous images (stop, dynamic road
mapping, cinema-loop, etc.).
– The least one multi-presentation monitor in the control room des
tine to actual time imaging.
– The provision of multi-presentation monitors makes the duplicity of
the same unnecessary (point out the advantage for the doctor, since
it increases concentration and diminishes fatigue).
– Column of high definition flat television monitors (minimum of 4)
for the following tasks: actual time work image, previous images
(stop, dynamic road-mapping, cinema-loop), intravascular echo
graph and polygraph (desirable).
230
Arch conditions
– Fixed on the ceiling or on the floor is acceptable depending on the
available space characteristics and user preference.
– Isocentric gyration.
– Multi-directional ability with angular cranial volume not inferior to
+45º and rotational not inferior to +90º. Parking capacity and maxi
mum flexibility of handling. Motorized movements.
– Anti-collision system with automatic stopping.
– Variable tube-intensifier distance without alteration of the iso-cen
tre.
– Manual capacity of movement, besides motorized (desirable).
– Digital visualization system of rotation grades and inclination
(desirable).
– Programming capacity for the automatic movement of different pre
viously chosen projections (desirable).
Exploration table
– Carbon fibre board.
– Electromagnetic blocking system which permits manual transversal
and longitudinal movement.
– Motorized vertical movement.
– Facilities for the connection of the module of data acquisition from
the polygraph and optionally with a handling console for the
intravascular echo-graph equipment.
– Ample margin in any movement.
Automatic injector of the contrast means
– Coronary and general multi-service ideally.
– With capacity for synchronized injection, respectively, to the cardiac
rhythm and radiology shot.
– Support for non-reusable syringes.
– With capacity for the selection of different speeds and injection
pressures.
231
Anti-radiation protection system
– Surface protection of exposed areas shall be assured, especially thy
roid and eyes.
– There shall be lead glass (2 mm of equivalent lead), like panels or
over articulated ceiling support.
Surgigal ceiling light
It is necessary for performing activities such as pacemaker implant or per
cutaneous aorta valve implantation procedures, to assist in the surgical dis
section of the arterial access.
Equipment for intra-coronary diagnosict thecniques
As in the intra-coronary echo-graph, optical coherence Tomography or the
pressure guide system. Every hemodynamics unit shall have any of these
techniques which permit the resolving of those situations in which the
angio-graph does not results conclusive in diagnosis as well as in therapeu
tic coronary intervention. They are not considered indispensable, but are
very recommendable, especially in the intravascular echo-graph. Their use,
obviously always selective, is a quality indicator.
Equipment for caridac physiology
It is included in this epigraph of joint systems obtaining, monitoring, regis
ter and processing during cardiac catheterization from the ECG surface and
the following intravascular parameters. Intracavitary pressures, systemic
and pulmonary blood flow volume/minute (essential) and intracoronary
pressure (advisable).
The computerized poli-graph, for the collection, storage and process
ing of hemodynamics data with capacity to make all calculations related to
said data, continuous digital information in actual time of cardiac frequen
cy and monitored pressures, and the automatic elaboration of the final
report. It shall permit the simultaneous register in 6 channels, two for pres
sures, two for ECG and the corresponding signal from two universal ampli
fiers. System of inscription within which provides a register speed between
232
5 and 200 mm/s. with capacity for simultaneous reproduction of at least 6
signals.
Provided with a complete and computerized package actualized for
analysis in actual time and post-procedure of diverse parameters, such as
mano-metric, gradient and valve area tendencies. It shall incorporate text
and curve monitors, in the exploration as well as in the control room.
The non-reusable or reusable pressure Transductors with a sensibility
not inferior to 400 mmHg and an perfectly gradual answer to any calibra
tion signal.
It is necessary to have at least one system for the calculation of cardiac
wear, with digital data presentation. It can be by independent Thermo-dilu
tion or incorporated to the poly-graph or by the direct Fick method through
oximetry. Oximeter, with digital data presentation of percentage analysis of
oxygen saturation in blood.
Equipment for reanimation and vital support
All personnel on the team, doctors, ATS, auxiliaries and technicians, shall be
familiarized with cardio-pulmonary reanimation.
The stop cart, placed at the head of the patient:
– Defibrillator monitor, trasncutaneous electrodes.
– Systems for oxygen application.
– Systems for intubation (laryngoscope and tubes).
– Ventilation system.
– Aspiration catheters.adrenaline, diazepam, isoproterenol, atropine,
digital, lidocaine, adenosine, diltiazem, magnesium, bretilio, docuta
mine, midazolan, bicarbonate of soda, dopamine, morphine, beta
blockers, betea, etomidate, nytroglicerine, calcium chloride,
furosemide, procainamide, anexate, verapamilo.
With regard to inhalation, preoxinenation with O2 at 100% shall be
done, without inhalating more than 15 seconds in a row and by extracting
the catheter with a rotary movement. The equipment inhalation pressure
shall be between -80 and -120 mmHg. The inhalation catheter shall be ster
ile and disposable, long enough and bigger that the endotracheal tube; min
imum frinction resistance, mould edges and side holes for the mucus trau
matism to be minimal.
External generator for provisional pacemaker. The most adequate and
safe type is the trans-cutaneous, incorporated to the monitor / defibrillator,
with a para-sternal electrode and another one on the back side. It is used in
233
bradycardia with hemodynamics transcendence, in a short interval as a
trans-vein bridge.
The defibrillator application with trans-demic stimulation shall be the
as early as possible. The users shall be familiarized with this machine. The
position of the electrodes, the application of the conducting materials and
the selection of the level of energy shall be adequate. The accumulator shall
be charged. It shall be assured that there are no personnel in contact with
the patient before the application of the discharge. The maintenance in the
operative state will be performed through check lists. The types of perfusion
pumps are:
Injector syringe; of a single system; of double system, more conforma
ble thanks to space and less devices on the seriously ill patient.
Optional elements
More and more often, it is more necessary to have support circulatory sys
tems in the hemodynamics unit, as a consequence of the generalization of
certain procedures like the percutaneous re-vascularization of the common
trunk; primary angio-plasty in infarction and in cases of cardio-genic shock;
or the intervention on structural cardio-pathologies (valves, closing of congenital defects in the adult…).
It is indispensable that there be a intra-aorta contra-pulsation balloon.
The catheters shall be ready in the hemodynamics unit, but the console can
come from the coronary or cardiovascular post-operatory, it shall be adapt
able to any type of balloon, transportable and with a minimum autonomy of
3 h. The use of the percutaneous implantation system of cardiopulmonary
referral has become extended, conceived as a measure of hemodynamics
support in patients in cardio-genic shock (post-infarction, non ischemic
myocardial pathologies, post surgery…) as a bridge to a cardiac transplant
or waiting for a certain functional solution (for example, myocarditis, post
infarction with re-perfusion).
The prolonging of the waiting period for a cardiac transplant in 0 alert
which is observed in these last years, makes these systems more necessary.
Nevertheless their placing is much more frequent in the field of the coro
nary unit and cardiac post-operation patients or in the cardiovascular oper
ating room than in the hemodynamics unit.
234
Imagery file systems
It shall have its own image file, which permits the immediate revision (<30’’)
of any study with, at least, the same speed as the acquisition (12.5-25 fps). It
shall be integrated in the computerized system, with the clinical file system
and physiological parameters, and permit communication wit the hospital
ization network.It shall support the DICOM 3 protocol (or the actualization
at the time of its installation), ACC/NEMA norm, for communications as
well as the file images format. The DICOM conformity documents shall be
included in the proposal. It shall support the HL7 protocol for the integra
tion of other hospital information systems.
The use of the IHE recommendation in its implementation of integra
tion in the hospital will be valued.It shall be integrated with the information
system of the unit which implies the synchronization of work lists (Work
list).
It shall be able to import the quantification results of the images as
well as the hemodynamics measurements.The acquisition and file from the
flat panel will be performed «on line» automatically and immediately.
It shall be able to store intravascular echo-graph images. Other modal
ities (poly-graph, pressure, physiological signs, etc.) will be valued, the inte
gration, time periods and possible additional costs appearing.
Convenient:
– The capacity of storage shall, in any case, have instantaneous access
at least from two work years. It shall specify the capacity and the
long term historic file system.
– It shall permit the obtaining of a multi-media version (DivX, AVI,
mpeg, etc.) of the stored images for their web presentation.
– It shall permit the modification of identifying, demographic and
administrative data, by the authorized system administrator.
Quantification and diagnosict stations
Permit the visualization of filed images in less than 30’’ (diagnostic revision)
and will permit visualization from external supports (CD, DVD…).
It is good that revision tools be incorporated, it have quantification
software, the possibility of having software for importing and quantifying
other image modalities (MR, CT…) and permit exportation of DICOM
images from one or various patients in extraction form, generating a cata
logue type DICOM Dir.
235
Remote revision station
The remote revision stations are very convenient, being able to be integrat
ed in the hospital information system. They shall be connected with the
Hemodynamics digital file, and ideally shall permit the visualization in actu
al time of clinical data and angio-graphs. There will be safety measures
demanded for the handling of personal data.
Clinical information
The unit shall have a database. There are various specifically designed for
the hemodynamics unit, which permit storage and management of all
patient data:
The simultaneous access with the base and the image files will permit
the revision of each case in an integral manner to elaborate reports, studies
or statistics. This system, besides fulfilling the legal requirements for data
protection shallimágenes archivadas en menos de 30’’ (revisión diagnóstica)
y permitirá visualizar desde soportes externos (CD, DVD…) shall:
– Support DICOM 3 (Norm ACCINEMA).
– HLT protocols or later performances of the same, as well as IHE
recommendations.
– It shall be configurable for its adaptation to the necessities of the
user.
– It shall be integrated in an automatic and immediate manner with
the acquisition of fluoroscopic images.
– The application of image visualization and making up of hemody
namics reports shall be able to be installed in the same stations,
capable of launching the image visor from the visualization system.
– It shall permit a bi-lateral communication with the rest of the exist
ing medical devices in the unit and with the hospital information sys
tem for works lists (work list).
236
Annex 8. Dimensioning of the
CCUs in a regional services
network
The determination of the basic dimensions of the healthcare resources of
the CCUs depends on demographical factors (structure of the population
attended to), epidemiological (morbidity), clinical (criteria of indication of
different modalities which make up the services roster of each unit) and
management (use of the provided productive capacity, distribution of work
loads between the different units, relation and management of the demand
with the primary healthcare level, etc.).
It is necessary to estimate the medium term demand and adequate in
it the dimensions of the CCUs, adjusted to a previously established profile
of productivity. To this end you start from the medium term population pro
jection (10 years), proposing different scenarios which keep in mind the
evolution of the demand in the determined territorial field, the specific vari
ables of this territorial field, demand management and the organization and
management of healthcare. Throughout this document the importance of
the healthcare network concepts and regionalization of services has been
underlined, for which this section of dimensioning has opted for an
approach to the whole of the CCUs within a region.
For this it has done in this section an exercise of dimensioning in a
hypothetical hospital network which will serve 1.200.000 inhabitants. It
would be made up of local hospitals, health area hospitals and a reference
hospital. The local hospital would have a reference population of 50.000
inhabitants and 60 beds (1.2 beds per thousand inhabitants). The health area
hospital would have a population of about 250.000 inhabitants and 500 beds
(2 beds per thousand inhabitants), be capable of serving as a support for
local hospitals.
The regional reference hospital, with about 780 beds, which attends to
an area of 350.000 inhabitants being able to support local and health area
hospitals, and whose CCUs would have a reference character for a total
population of 1.2 million inhabitants.
The dimensioning of the units which are described in Chart A.8.1 refer
to each one of the hospital types described.
237
238
239
240
241
The criteria for the calculation of resources figure in Table A.8.2
242
243
244
Annex 9. Specific premises plan
of the heart area
In table 9.1 the premises plan for two possible cases is set forth: with (B) or
without (A) heart surgery, with the maximum level of integration of each of
its areas, as recommended in this guide.
In the event of the impossibility of the integration recommended in
the document, the all the physical resources needed for each area to carry
out its activity in a proper way are to be taken into account.
245
246
247
248
Annex 10. Equipment
programme(86)
86
Numerical references are avoided as the number of equipments will depend on the size and
other structural and functional variables of the CCUs.
249
250
251
252
253
254
255
256
257
258
259
260
261
262
263
264
Annex 11. Advanced training
in hemodynamics and
interventional therapy(87)
The European Society of Cardiology intends to harmonize the different
recognition of the advanced training. The accreditation consists of three
modules: knowledge, skills and attitude.
Knowledge
– Anatomy and cardiovascular physilogy.
– Biology and vascular pathology.
– Physiopathology (with clinical uses: intracoronary image,…).
– Pharmacology (including anti-thrombotic agents and thrombotic
therapy, contrast agents).
– Radiological image and safe use of radiation patient selection, indi
cations and limitations.
– Design and performance of the interventionalt devices.
– Clinical management and strategy, before and alter the procedure.
Skills
– Procedure schedule. All professionals under training shall hold a
continuous record of the procedures they perform in the hemody
namic lab. The procedure schedule must give details of the injury
complexity, the types of devices used and the complications. It must
also indicate when the case was planned and emergency.
– The skills assessment of the interventional cardiology accreditation
shall include three directly observed procedures (DOPs) for each of
the following aspects of the curriculum for nuclear medicine: diag
nostic cardiac catheterization, percutaneous coronary intervention
(PCI) for benestent-like lesions, PCI for acute coronary syndrome,
(87)
Javier Goicolea.
265
PCI for ST elevation acute coronary. The directly observed proce
dures shall be carried out at the beginning, in the middle and at the
end of the training so that the progress can be noted down (three of
each type).
Attitudes
– To learn PCI techniques and prove the capacity to get to know, both
through learning and in independent way.
– To treat each patient as an individual and design each intervention
for each particular case.
– To foster a good relationship among the multitasked team.
– To have a calm behaviour when the PCI passes off in a complicated
manner and with adverse effects.
– To be able to write a condolence letter to the families after a patient dyes.
These modules are assessed in an independent way. The section of
hemodynamics and intervention cardiology is taking part in the develop
ment of a system that includes the creation of a standardized list of topics
common to all Europe. El goal consists of a common certification, depend
ing on each country’s obligatory nature of criteria.
Training level
In hemodynamics and interventional cardiology, there are three levels of
training236,237:
– Level 1 training in cardiac hemodynamics, but without capacity to
subsequently do cardiac catheterization in an independent way.
– Level 2 training to do diagnostic cardiac catheterization in an inde
pendent way.
– Level 3 training to do diagnostic cardiac catheterization and inter
ventional or percutaneous therapeutic procedures (PCI, aterectomy,
stent implantation, valvuloplasty, etc.).
Training elements
The level 1 of training in cardiac hemodynamics, but without competence to
subsequently do cardiac catheterization in an independent way. He/she
266
must know the medical and surgical limitations, complications, indication
and implications of the cardiac catheterization findings and comprehend the
related interventional procedures and the physiopathology procedures and
interpret the hemodynamic and angiographic data.
He/she shall be able to do right heart and percutaneous pulmonary
artery catheterizations (jugular, femoral, subclavian), temporary pacemaker
insertion in the right ventricle, and have experience in left heart catheteri
zations, ventriculography, coronariography and pericardiocentesis. The
training period must range from 4 to 6 months and requires participating in
100 procedures, both doing and assessing them before and afterwards. This
training does not qualify for doing diagnostic cardiac catheterizations in an
independent way.
The level 2 of training to do diagnostic cardiac catheterization in an
independent way. He/she must have an additional training in percutaneous,
arterial or venous catheterization. Likewise, he/she shall have knowledge on
radiation (level 1), safety, radiology and hemodynamics lab equipment
(transducers, recording, gas analyzers, intensifiers, X-ray equipment, digital
signal processing, film controller digital signal controller, etc.). He must
have knowledge on cardiovascular system physiopathology, principles of
shunt detection, cardiac output determination and pressure waveform
recording and analysis. He/she must have experience in doing the different
kinds of diagnostic cardiac catheterizations: coronariography valvulopathy,
myocardiopathy, etc. He/she must have a special training in endomyocardial
biopsy and in intra-aortic balloon counterpulsation insertion and handling.
The training in level 2 requires a minimum period of 12 moths with
more than 300 procedures done including 200 diagnostic procedures as a
first surgeon. Doing catheterizations in complex congenital cardiopathy
requires a specialized training in a hemodynamics lab with a high volume of
paediatric catheterization. In order to maintain the qualification level
reached at this level, it is necessary to do at least 150 catheterizations per
year.
The level 3 of training prepares professionals to do diagnostic heart
catheterizations and interventional or percutaneous therapeutic proce
dures. He/she must have wide knowledge of cardiac anatomy, physiology
and physiopathology, clinical vascular biology, hemodynamics, ischemic car
diopathy (IC) and coagulation requirements and equipment, especially in
physiology and antiplatelet, antithrombotic and thrombolytic pharmacolo
gy. He/she must perfectly know the indications and contraindications of per
cutaneous interventional procedures, surgery and medical treatment, as well
as experience in prevention, diagnosis and treatment of possible complica
tions after procedures (coronary artery dissection, perforation, no-reflow
phenomenon, hemorrhagic and vascular complications, etc.). The training
267
period requires a Level 2 plus a minimum of 250 intracoronary interven
tional procedures where he/she acts as first surgeon. It is assumed that in
many of these procedures a conventional PCI with stent implantation will
be done. For the training in other interventional techniques it is required to
participate in at least ten of these specific procedures. Having into account
the interventional cardiology technique, the emergence of new endovascu
lar intervention techniques and devices requires additional knowledge,
which, in turn, requires an specific training, as these procedures are very dif
ferent from the conventional PCI. These new techniques can be divided into
three types:
– Techniques that have increased the indications and applications of
conventional PCI. With regard to the procedure volume, not all the
intervention professionals shall be able to perform them, since their
use is optional and it is possible to do them following a schedule.
Each surgeon is individually and collectively responsible (in each
centre) for deciding which techniques are implemented according to
their need, complexity and volume. Maintaining qualification in
these techniques depends on the surgeon’s general experience and
on the procedure complexity. Very complex procedures require a
higher level of continuous experience.
– Techniques used to treat complications alter interventional proce
dures. The most frequent are perforation treatment, recovery of a
foreign body and the no-reflow phenomenon. All interventional
cardiologist shall be trained and have experience in the handling of
these uncommon complications, but potentially fatal.
– Techniques for the treatment of non-coronary cardiopathies, usually
included under structural cardiopathy. These techniques have two
main features: a) low incidence compared to coronary cardiopathy,
for which experience concentration is advisable; b) the frequent need
of more important points of access; and c) the combination with sur
gical techniques to perform hybrid procedures (for example, aortic
pathology, which implies the arch, or complex congenital car
diopathies). This area of interventional surgery almost represents a
new discipline where non-coronary endovascular techniques, paedi
atric cardiologists and surgical approaches converge. That is why,
apart from concentration, it requires multitasked teams and some
times, hybrid operating theatres.
268
Maintaining qualification
The most recent comparative data indicate that the mortality and urgent
surgery rates for all kinds of coronary interventions must be below 1% and
3% respectively, with a success rate in the major procedure of 90%. There
are reasons to assume that these figures have decreased in the last few years
and thus stand for a higher limit in absolute terms compared to the rate of
complications expected in a clinically stable population. There is likely a
relationship between the number of cases done by an individual surgeon
and the results320,321,322,323, so that the surgeons performing a lower number
of procedures obtained less favourable results than those performing a
higher number. However, there are some surgeons with a volume of yearly
cases lower than the established requirements who obtain excellent results.
This relationship is probably influenced by a possible interaction between
the hemodynamist and the total number of cases of the hospital where the
procedures are done, so that the results of surgeons with a low volume in
institutions with a high number of cases are generally more favourable than
the ones obtained by surgeons with a low volume in centres with few cases.
Nevertheless, the absolute differences in complications rates between insti
tutions and surgeons with a los and high volume are small. In the New York
state’s database, surgeons doing less than 75 procedures per year had 1% of
mortality rate and 3.9% of surgery need, while surgeons with a higher vol
ume have rates of 0.9% and 3.1% respectively.
Training centre
Multiple data indicate that they is a almost logarithmic relation between the
number of procedures done in an specific centre and the results obtaines
(Jollis, 94; Hannan, 97). In general, the hospital in which the few procedures
are done have a higher incidence of complications, mainly death and the
need of urgent surgery due to failed intervention, than a hospital doing a
higher number of procedures. It is necessary that each centre have a good
and effective monitoring of the cardiac catheterization and interventional
therapy programme, both generally and individually of the surgeons. The
centres must try to maintain a level of activity of more than 400 procedures
per year. The centre with less than 200 yearly procedures shall carefully
assess the interventional indications242. he laboratory that offers the level 2
training in hemodynamics shall have more than one expert hemodynamist
among the staff. For the training in interventional procedures, there must be
at least an hemodynamist expert in the training subjects.
269
1) Infrastructure and equipment adapted to the recommendation set
by the SEC in its guides of action. Centre’s minimum volume of 500
angioplasties/year.
2) The existence within the team of at least one intervening cardiolo
gist who commands all the cognitive and technical abilities which a
cardiovascular intervention requires, a historical volume of no less
than 1000 angioplasties and a minimum annual activity of 200
angioplasties.
3) In order to offer a globally satisfying advanced training, the unit’s
casuistry shall include a sufficient volume of all the possible sub
groups of risk and complexity, including angioplasty in acute heart
attack.
4) The use of several interventional cardiovascular diagnostic and
therapeutic techniques.
5) A hemodynamics team on the alert (24 hours/day, 365 days/year)
covering the treatment of patients with acute coronary syndrome
requiring urgent interventions and sick patients who suffer or may
suffer from complications resulting from interventional techniques
o who need special care as a consequence of them.
6) A heart surgery and postoperative programme allowing an optimal
global training. It shall include the possibility of getting familiar
with the following aspects:
– The indication of the different kinds of revascularization in a real
scenario.
– The real possibility of the combined or complementary use of the
different techniques of revascularization.
– Complex percutaneous interventions with real surgical support.
The decision-making process, the implementation of support meas
ures and the surgical action logistics in cases of extreme seriousness
resulting from interventional therapies and the real usefulness of
the surgical support for percutaneous interventions in those cir
cumstances. A theoretical and practical training programme specif
ic to this training period, which would be accredited.
7) Proving a minimum level of activity and scientific curiosity in inter
ventional cardiology handing in three scientific communications
regarding this activity in the last three years at congresses on the
specialization (annual SEC congresses, European Society of Cardi
ology, American Heart Association, American College of Cardiolo
gy) and through the release of at least an original scientific related
to interventional cardiology in the last three years and subjected to
a peer revision in a magazine included in Medline.
270
The assessment of these criteria will be done as a whole having into
account each unit’s general scientific-technical profile. The failure to meet
any of them does not necessarily exclude obtaining the accreditation as a
teaching unit.
271
Annex 12. Training requirements
of an electrophysilogy
cardiologist(88)
The great development of electrophysiology, specially in its therapeutic
aspect, made it necessary to regulate the training and accreditation of car
diologist in charge of the arrhythmia units326,327,328,329,330. In the United Sta
tes a specific learning programme and a certificate of clinical electrophysio
logy was created by the American Board of Internal Medicine in 1992. Dif
ferent European countries are regulating the electrophysiology practice. A
few years ago, the electrophysiology and arrhythmia department of the Spa
nish Society of Cardiology introduced a training course in electrophysiology
in Spain for professionals, despite the absence of a regulation requiring the
cardiologist degree for the practice of electrophysiology. Besides, in some
countries, these procedures are performed by non-cardiologist doctors.
Likewise, a system was created to authorize centres that can offer an elec
trophysiology training programme.
Teaching objectives for fellowship programs in
clinical electrophysiology
The goals of the training programme in electrophysioly are offering cardio
logists necessary knowledge to safely and efficiently develop a cardiac
arrhythmia diagnostic and treatment programme. To do that, the program
me includes specific training in:
– Basic electrophysiology.
– Action mechanism and handling of antiarrhythmic drugs.
– Indications of the non-invasive and invasive techniques.
– Non invasive techniques (ECG, Holter, late potentials, tilt-table
tests, electric cardioversion, etc.).
– Invasive techniques (electrophysiology studies and ablation proce
dures with catheters).
(88)
Josep Brugada; Brugada y cols., 2001.
273
– Handling of complications resulting from invasive techniques.
– Implantation, planning and follow-up of pacemakers and automatic
defibrillators.
The candidates to a specialization programme in electrophysiology
shall hold a specialization degree in cardiology, which is the only one certif
ying a sufficient education as a general cardiologist, essential for the correct
overall handling of these patients.
Centres requirements to offer a specialization
programme in electrophysiology.
The centres shall be authorized by the national committee for cardiologist
education (MIR programme). There shall be an arrhythmia unit with at
least two full-time electrophysiolgists who are be responsible for the trai
ning. These electrophysiologists shall have advance education in elec
trophysiology recognised by the SEC. The unit shall be provided with all the
non-invasive and invasive tests (ECG, Holter, tilt-table test, cardioversion,
electrophysiology studies, radiofrequency ablation, implantation and
follow-up of pacemakers and automatic defibrillators, etc.). The unit shall
assure a minimum activity of procedures to be able to offer the training,
currently estimated at 150 ablation procedures a year. In the training all the
medical practice procedures that figure in the section’s register are dealt
with. During the training period, the cardiologist under training in elec
trophysiology shall work exclusively in the unit. This shall accredit some
research lines allowing also the training in this field, as well as a regulated
activity of real medical sessions and a scientific production in form of mee
tings and peer review publications.
274
275
Capacity maintenance
To maintain the acquired knowledge and skills obtained during training, it
is necessary for the cardiologist to stay linked to the clinical electrophysio
logy. To maintain these skills the electrophysiologist must perform a mini
mum of 50 ablation procedures per year and must follow continuous trai
ning in the speciality.
276
Annex 13. List of devices and
systems needed in an operating
theatre of cardiovascular
surgery
– A minimum of 8 electrical panels with 4 sockets, the biggest number
of them placed in the operating rooms tower to avoid the presence
of cables in the transit areas.
– Warm and cold water taps.
– Specific set of cardiovascular surgery instruments.
– 5 modules extracorporial circulation console complete with acces
sories and annexed maintenance.
– At least two centrifugal pump modules.
– Automatic heat exchanger.
– A minimum of 6 pharmaceutical infusion pumps.
– A minimum of 3 pressure transductors. Gasses, haemoglobin and
ions determination device.
– Heparin and coagulation time control systems.
– Central monitor and at least a satellite terminal with: 3 pressure
channels.
– Two ECG channels Cardiac output module.
– Polygraph and recorder.
– Frontal cold light source.
– External/Internal defibrillator with adjustable power between 5 and
400 J, appropriate paddles.
– At least 3 sternum saws with rechargeable batteries.
– Ultrasound scalpel.
– Serums and blood heating systems.
– Echo-graph with trans-oesophagus catheter.
– Blood recovery and autotransfusion system.
– At least 3 external single chamber pacemakers and 3 external dual
chamber pacemakers.
– Arrhythmia mapping and ablation system.
– Circulatory assistance console.
– Thoracoscopy - video tower.
– Radiology system for endovascular and trans-catheter techniques.
– Images amplifier.
277
Annex 14. Structural resources,
systems and devices needed in
the post-operative intensive
care unit of cardiovascular
surgery(89)
All the systems further described should fulfil the regulation on occupa
tional-risk prevention.
General basic needs
– Basic analytic system to determine gasses, glycemia, electrolytes,
hematocrit and calcium heparin and coagulation time control sys
tems .
– At least 3 disposable air patient warming mattress systems.
– At least 4 enteral feeding pumps.
– At least 2 external dual chamber pacemakers.
– At least a 12 channels ECG recording system.
– A fully equipped crash cart.A sternotomy material cart fully
equipped.
– Echo-graph with trans-oesophagus catheter.
– A fiber optic system for difficult intubations.
– At least one contra pulsation aortic console with accessories.
– Patient mobilization crane with two harnesses.
– Various clinical work terminals connected with the centres network.
– Sistema de control de la heparinemia y el tiempo de coagulación
activado.
(89)
For an activity of 600 surgical interventions with extracorporeal circulation or aortocoro
nary graft without extracorporeal circulation. See also: Intensive care unit. Estándares y reco
mendaciones. NHS Agency of Quality. Ministry for Health and Social Policy. 2010. This attach
ment refers to those specific resources.
279
Intensive care box
– A minimum of 9 intensive care boxes.
– A minimum useful area of 20 m².
– At least one box needs to have a 30 m² surface, to attend high com
plexity patients that are threatened with big size technology.
– At least two of them need to have the capacity for environmental or
human insulation.
– Appropriate electrical insulation.
– Adjustable direct and indirect lighting.
– Portable or dome light for executing surgical procedures.
– Water intake for dialysis.O2, vacuum, compressed air intake.
– Technical rail fully with accessories.
– Electricity connected to a UPS and to a generator.
– Last generation volumetric ventilator.
– Anaesthetic gases providing tower.
– Multichannel monitor with at least 5 modules and a monitoring
capacity of at least two pressures, one of cardiac output and another
of O2 saturation.
– Connection with the nurse station.
– At least 6 pharmaceutical injection pumps in the CCU box and 2 in
the intermediate care unit.
– Electric vacuum system.
– A multifunctional articulated electric and mobile bed with an anti
decubitus mattress.
– Anatomic armchair for the patients mobilization and mayo stand.
– Wash basins for procedures with accessories.
– Desk chair with desk table for the nurse station.
– Patients clinical data computer terminal.
– Containers for collection of selective waste.
– Containers for collection of risk products.
280
Annex 15. Specific needs of the
hospitalization room for
cardiovascular surgery(90)
General
– An electrocardiograph.
– An external dual chamber pacemakera vascular echo-Doppler.
– A laptop with at least three modules.
– At least 6 medication infusion pumps.
– At least 3 enteral feeding pumps.
– A crane with two harnesses for patient´s mobility.
– A system to have the appropriate amount of light for all the proce
dures.
– A room for cures with basic surgical tool.
Hospital bed
– Complete technical bar with accessories.
– Compressed air, O2 and vacuum sockets.
– Electrical articulated bed with easy exit from the room.
– Electrical connections for high power apparatuses.
(90) See: Unidad de enfermería de hospitalización polivalente de agudos. Estándares y reco
mendaciones. NHS Agency of Quality. Ministry for Health and Social Policy. 2010. This attach
ment refers to those specific resources.
281
Annex 16. Alphabetical index
of definitions and terms of
reference
Accreditation
Certifying an information system or network as competent for proces
sing sensitive data and determining the extent to which the system design
and materialization comply with the technical safety requirements already
established. Procedure to which an organization is submitted voluntarily
and whereby an independent organization certifies that the requirements of
a given model are met.
Admitted patient
Patient admitted (stays overnight) in a hospital bed.
Adverse effect
It is defined for this studyas every accident or incident that appears in
the patient’s medical record that has or may have caused him pain, and that
is specially linked to healthcare conditions. The accident can extent the
hospitalization time or cause an after-effect on the patient’s discharge,
death, or a combination of them. The incident does not cause injury or
pain, but can affect them.
In order to meet this condition, there must be an injury or complica
tion, extended stay, subsequent treatment, disability upon a patient’s dis
charge or exitus, consequence of the healthcare received, and from modera
ted probability that the handling is the cause to total evidence of it.
Source: Estudio Nacional sobre los Efectos Adversos ligados a la Hos
pitalización. ENEAS 2005. MSC.
Authorization
Healthcare authorization: administrative resolution that, according to
the established requirements, authorizes a healthcare establishment, centre
or service to set up, function, modify its medical activities or, where appro
priate, close.
Source: R.D. 1277/2003, of 10th October, laying the general basis for the
authorization of healthcare centres, services and establishments.
283
Authorization requirements
Requirements, expressed in qualitative or quantitative terms, that have
to be met by healthcare establishments, services and centres to be author
ized by the healthcare administration and that are aimed at ensuring that
they have the appropriate technical means, facilities and professionals for
conducting their healthcare activities.
Clinical documentation
Any data, regardless of it form, class or type, allowing to get or broaden knowledge on the physical state and health of a person or on the way
to preserve it, take care of it, cure it or recover it (Art. 3 of Law 41/2002,
regulatory basis for the patient’s autonomy, rights and obligations concer
ning information and clinical documents).
Code of ethics
Set of standards or ethical rules that the healthcare centre applies to
the professional conduct related to its patient’s care.
Conventional hospitalization
Admission of a patient with an acute or cronic re-acute disease to an
organised nursing unit that is capable of providing healthcare and interme
diate and non-critical care 24 hours a day, and where patients stay more than
24 hours. The advisable features of this hospitalization nursing units that are
appropriate for treating a patient suffering a heart disease are explained in
this document.
Source: Unidad de enfermería de hospitalización polivalente de agu
dos. Estándares y recomendaciones. QA-NHS. MSPSI 2010.
Critical care
It is an integral system that responds to the needs of those patients at
risk of critical disease during the disease itself and those who are already
recovered from it. Its provision depends on the availability of continuous
experience and facilities, within hospitals and between them, regardless of
the place and the speciality.
Comprehensive Critical Care. A Review of Adult Critical Care Servi
ces. Department of Health. May 2000.
284
Day hospitalization
Healthcare modality that is aimed at providing treatment or care to ill
patients who undergo treatment or diagnostic methods requiring conti
nuous medical or nursing attention for some hours, but not the hospitaliza
tion in the hospital.
Source: Unidad de urgencias hospitalarias: estándares y recomenda
ciones. AC-SNS. MSPSI 2009.
Discharge report
Document issued by the doctor responsible for a healthcare centre at
the end of every healthcare process on a patient or on a patient’s transfer to
another healthcare centre, in which figure the patient’s details and medical
record summary, the healthcare provided, the diagnosis and the therapeutic
recommendations.
Other similar terms used: medical/clinical discharge form (Art. 3 of the
basic regulatory Law 41/2002 on patients autonomy and on the rights and
duties in relation to medical information and documentation); Order by the
Ministry for Health, of 6th September 1984.
Emergency
That urgent situation that put the patient’s life or an organ function at
risk.
Source: WHO.
Healthcare emergency that put a person’s life or important biological
functions at -real or potential- risk and that requires qualified immediate
care on the spot. Special kinds of emergency are: the multi-victim accidents
or collective emergencies (those in which the system healthcare capacity is
exceeded when there are several patients) and the catastrophe, which is that
situation where available resources are not enough to face healthcare needs.
Source: Grupo de Trabajo SEMES. Calidad en los servicios de urgen
cias y emergencias. SEMES, 1998.
Emergency department
An organization of healthcare professionals offering multidisciplinary
attention in a specific area of the hospital, which fulfils functional, structu
ral and organizational requirements. This way, it assures appropriate safety,
quality and efficiency conditions to treat patients with diverse aetiology and
diverse seriousness problems. These patients are not hospitalized but suffer
from acute diseases requiring immediate care.
285
ciones (Eemergency department: standards and recommendations. AC
SNS. MSPSI 2010.
Healthcare centre
Organized group of technical resources and facilities in which quali
fied professionals (for their official certification or professional authoriza
tion) carry out healthcare activities with the aim of improving people’s
health.
Healthcare intervals
Examination interval – healthcare request: Time in minutes from the
examination start time until the healthcare request time. TS-TC.
Healthcare request interval – defibrillator: Time elapsed in minutes
from the healthcare request time to defibrillation possibility time. TD-TS.
Examination interval – hospital: Time elapsed in minutes from the exa
mination start time until the time of access to the hospital. TH-TC.
Hospital interval – ECG: Time elapsed in minutes from the time of
access to the hospital until the time of the ECG. TE-TH.
Examination interval – revascularization treatment: Time elapsed in
minutes from the examination start time until the revascularization treat
ment time. TR-TC.
Healthcare request interval – revascularization treatment: Time elapsed
in minutes from the healthcare request to the revascularizing treatment
(«time needle call» «balloon call»). TR-TS.
Hospital interval - revascularization: Time elapsed in minutes from the
time of access to the hospital to the revascularizing treatment time («door
needle « «door balloon»). TR-TH.
Source: Estrategia en Cardiopatía Isquémica del NHS (Strategy for
Ischemic Cardiomyopathy of the NHS). Updating adopted by the NHS
Inter-territorial Council on 22th October 2009. MSPSI.
Healthcare network
The ECI-NHS defines the healthcare network as coordinated work,
according to the grade of complexity, of the different levels of healthcare
(healthcare at home, extra-hospital emergency, healthcare in health centres,
286
hospital emergency, programmed hospital healthcare, reference services
and others) in a determined territory (for example, health area, region, etc.)
to attend to in a continuous manner and in the most efficient way possible
different clinical situations.
Source: Estrategia en Cardiopatía Isquémica del NHS (Strategy for
Ischemic Cardiomyopathy of the NHS). MSC. 2006.
Informed consent
Free, voluntary and conscious consent by a patient, granted in his/her
sound and sober senses, after having received the proper information, so
that action effects his/her health can take place.
In-hospital nursing unit of multifunctional acute care
quality and efficiency conditions to treat patients with acute or chronic
acute diseases who, being hospitalized following medical or surgical proces
ses, do not require advance or basic respiratory assistance or assistance for
one or more organs or systems.
Source: Unidad de enfermería de hospitalización polivalente de agu
dos: estándares y recomendaciones (In-hospital nursing unit of multifunc
tional acute care: standards and recommendations). AC-SNS. MSPSI 2010.
Integral emergency system
Set of coordinated functional units working in a defined geographic
area to achieve a final goal, that is, reducing mortality of patients under
going some urgent processes and also reducing their after-effects.
ciones. AC-SNS. MSPSI 2010.
Intensive care unit
quality and efficiency conditions to treat patients who, being likely to reco
ver, need: a) advance respiratory assistance; or b) basic respiratory assis-
287
tance giving support to at least two organs or systems; and c) all complex
patients requiring assistance due to multi-organ failure.
Source: In-hospital nursing unit of multifunctional acute care. AC-SNS.
MSPSI 2010.
Intraining system
Group of processes, automatic or not, that, orderly interconnected,
designed for the administration and support of the different activities that
develop in the healthcare establishments, services and centres, as well as tre
atment and exploitation of the records that the formerly mentioned proces
ses produce.
Local hospital
In this document, a local hospital is understood as the hospital having
a reference area with a surrounding population up to 100,000 inhabitants,
and that is not enough to develop a services portfolio in medical and surgi
cal sub-specialities, such as cardiology.
Adapted from: National Leadership Network for Health and Social
Care. Strengthening Local Services: The Future of the Acute Hospital. 21st
March 20061.
Medical history
Group of records containing data, evaluations and information of any
nature on the medical situation and evaluation of a patient along with the
assisting process. It includes the identifications of the doctors and other pro
fessionals that have been contributed to the assisting processes (Art. 3 and
14 of the Law 41/2002, regulatory base of the patients autonomy, rights and
obligations concerning information and legal records).
Patient registry
Group of selected records about the patients and their relation with
the healthcare centre, with the aim of a healthcare healthcare process.
1
National Leadership Network for Health and Social Care. Strengthening Local Services: The
Future of the Acute Hospital. 21st March 2006.
288
Quality audit
«Process by which the books, accounts and registers of a company are
analysed in order to tell whether its financial statement is correct or not and
if receipts are properly submitted». Independent and methodological study to
determine whether the activities and the results related to quality comply
with the pre-established provisions or not, and to verify if these provisions are
effectively executed and if they are appropriate to achieve the intended goals.
Regionalization
Concentration of human resources, facilities and equipment in certain
centres to improve quality, safety and efficiency when being used.
Registry of healthcare establishments, centres and services
Set of notes of all the authorizations of functioning, modification and,
where appropriate, installation and closing down of healthcare centres, serv
ices and establishments, granted by the respective healthcare administra
tions.
Relevant healthcare times
Time of the start of the examination. (TC): Moment, expressed in
hours and minutes, at which the examination of the patient who is suspec
ted of suffering from ACS (acute coronary syndrome).
Healthcare request time (TS): Moment, expressed in hours and minu
tes, at which the patient or the person requested helps in a medical emer
gency system or attend a healthcare centre (clinic, hospital or resource).
Defribillation time (TD): Moment, expressed in hours and minutes, at
which the contact with the first healthcare resource with capacity to provi
de treatment with a defibrillator takes place.
Time of access to the hospital (TH): Moment, expressed in hours and
minutes, at which a patient access the hospital, regardless of the transport
means used (door time).
Time of ECG (TE): Moment, expressed in hours and minutes, at which
the ECG is used after a patient arrives to the hospital.
Revascularizing treatment time (TR): Moment, expressed in hours and
minutes, at which the patient gets the indicated revascularizing treatment:
289
fibrinolisis (TRF, thyroestimulin releasing factor), angioplasty (TRA, trans
radial sngioplasty) (needle time and balloon time respectively).
Time of the admission at the ICU/CU (TU). Moment, expressed in
hours and minutes, at which the patients is admitted to the intensive care
unit/coronary unit.
Services portfolio
Set of techniques, technologies or procedures, understood as each of
the methods, activities and resources based on scientific experimentation
and knowledge, through which healthcare services are provided in a health
care centre, service or facility.
Source: Royal Decree 1030/2006, of 15th September, establishing the
common services portfolio of the National Healthcare System and its upda
ting procedure.
290
Annex 17. Abbreviations and
acronyms
AC-SNS
ACC
AICD
AE
AEEC
AHA
AHRQ
National Health System Quality Agency.
American College of Cardiology.
Automatic Implantable Cardioverter Defibrillator.
Adverse Effect.
Spanish Society of Nursing in Cardiology.
American Heart Association.
Agency for Healthcare Research and Quality (Unites States of
America).
AMI
Acute Myocardial Infarction.
BCS
British Cardiac Society.
CC.AA
Autonomous Regions.
CCUs
Cardiology Care Units.
CHF
Congestive Heart Failure.
CPR
Cardiopulmonary Resuscitation Equipment.
CT
Computed Tomography.
CVS
Cardiovascular Surgery.
DCH
Day Care Hospital.
DCU
Day Care Unit.
DICOM Digital Imaging and Communications in Medicine.
DOPS
Directly Observed Procedures.
EAE
European Assotiation of Echocardiography.
EACTS
European Association for Cardio- Thoracic Surgery.
ECI-SNS Strategy for Ischemic Cardiomyopathy of the National HealthCare System.
EESCRI Statistics of Healthcare Establishments with Admissions.
ESC
European Society of Cardiology.
ESCUS
European Society of Thoracic Surgeons.
ETE
Echo-cardiography.
GRD
Groups Related by Diagnosis.
HMS
Hospital Morbidity Survey.
HFU
Heart Failure Unit.
IC-NHS Inter-regional Council of the National Healthcare System.
ICT
Information and Communications Technologies.
ICU
Intensive Care Unit.
IHI
Institute for Healthcare Improvement. (Unites States of Ameri
ca).
291
INE
INU
IOM
MBDS
MDCU
MIR
MSC
MSPSI
NCEPOD
National Statistics Institute.
Multi-service Inpatient Nursing Unit for Acute Patients.
Institute of Medicine.
Minimum Basic Data Set.
Medical Day Care Unit.
Examination to become a Resident Medical Internal.
Ministry for Health and Consumer Affairs.
Ministry for Health, Social Policy and Gender Equality.
National Confidential Enquiry into Patient Outcomes and
Deaths.
NICE
National Institute for Clinical Excellence (www.nice.org.uk).
NHS
National Health Service (United Kingdom).
NHS
Spanish National Healthcare System.
NMR
Nuclear Magnetic Resonance.
NQF
National Quality Forum (Unites States of America).
OMAP
Outpatient Monitoring of Arterial Pressure.
PCI
Percutaneous Coronary Intervention.
PC-SNS Spanish National Healthcare System Quality Plan.
PDA
Personal Digital Assistant.
PTCA
Percutaneous Transluminal Coronary Angioplasty.
RT
Resynchronization Therapy.
SEC
Spanish Society of Cardiology.
SECTCV Spanish Society for Thoracic and Cardiovascular Surgery.
SED
Spanish Society of Diabetes.
SEEN
Spanish Society of Endocrinology and Nutrition.
SEMN
Spanish Society for Nuclear Medicine.
SEN
Spanish Society of Neurology.
SEPAR
Spanish Society of Pulmonology and Thoracic Surgery.
SERAM Spanish Society of Medical Radiology.
SIGN
Scottish Intercollegiate Guidelines Network.
TOE
Transesophageal Echocardiography.
TTE
Conventional Transthoracic Echocardiograph.
UHE
Emergency Department.
WHO
World Health Organization.
292
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