Tubing Misconnections Self Assessment for Healthcare Facilities

Transcription

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Table of Contents
Program Overview................................................. 1
Process Flow......................................................... 7
Getting Started...................................................... 8
Data Collection.....................................................10
Analysis............................................................... 11
Action Plan...........................................................13
Appendix A: Data Collection Tool......................... 21
Appendix B: Data Collection Spreadsheet........... 25
Appendix C: Action Plan Templates..................... 26
Appendix D: References...................................... 34
Baxter and Connections Portfolio and Design are trademarks of Baxter International Inc.
All other trademarks, brands or product images appearing herein are the property of their respective owners.
Baxter Healthcare Corporation, Route 120 and Wilson Road, Round Lake, IL 60073, www.baxter.com 750432A 11/11
Program Overview
W
Welcome to the Tubing Misconnections Self Assessment for Healthcare Facilities
presented by the Baxter Clinical Center of Excellence and in collaboration with the
Institute for Safe Medication Practices (ISMP). This multi-tiered self assessment tool is
designed to help you identify the potential causes of inadvertent tubing misconnections
and to help prevent misconnections.
By successfully completing this self assessment, your institution will identify potential
tubing misconnection risks in major patient care areas and develop an action plan to
mitigate risks through established processes, device selection, and education.
Introduction
The Ease of Inadvertent Tubing Misconnections
Inadvertent tubing misconnections are frequent and preventable errors that
pose a significant risk to patient safety and can result in devastating outcomes.21
Tubing misconnections occur most often when Luer-activated tubing is mistakenly
connected to another type of tubing into which it can be fit, but for which it was not
designed. Healthcare providers use a variety of catheters, tubing, connectors, and
syringes to deliver medications and other substances to patients through various
delivery routes, including topical, vascular, enteral, respiratory, and neuraxial
(epidural and intrathecal). Luer connectors easily link various delivery system
equipment across multiple applications using the male and female components of
the connectors to create a secure yet detachable connection. Because of human
factors, the clinical environment, and the interconnectivity of Luer connectors,
healthcare professionals may mistakenly connect the wrong devices and deliver
substances through the wrong route.
Due to potential harm to patients, tubing misconnections have garnered the
attention of safety focused organizations including the FDA (Food and Drug
Administration), A.S.P.E.N (American Society for Parenteral and Enteral Nutrition),
ISMP (Institute for Safe Medication Practices), the ECRI Institute, TJC (The Joint
Commission), and USP (United States Pharmacopeia), as well as other patient
advocacy organizations and federal agencies.
Patient Injuries and Death
Tubing misconnections have led to serious patient injuries and deaths. In 2006, TJC
published in its Sentinel Event Alert that nine cases involving tubing misconnections
reported to the organization’s Sentinel Event Database had resulted in eight deaths
and one instance of permanent loss of function.21 A study published in Critical
Care Medicine (CCM) in 2005 found that 56 percent of 114 intensive care patients
involved in a “line, tube, or drain” incident sustained physical injury; 23 percent had
an increased hospital stay; and one patient died. ISMP, ECRI, and the FDA have
11
also reported serious injuries and deaths associated with tubing misconnections.1, 4, 8, 16, 19
1
Program Overview
Factors associated with tubing misconnections include:
1) Unsecured or loose line connections1
2) Use of unintended adapters that permit incorrect connections38
3) The positioning of functionally dissimilar tubes/tubing in close proximity to each
other (often called the “spaghetti syndrome”)2
4) The use of tubes, catheters, syringes, and connectors for unintended purposes
(such as using IV tubing and an IV infusion pump to administer breast milk
to infants, or using IV tubing and an infusion pump to connect solution to a
nebulizer cup in order to administer a constant flow of nebulized solutions of
respiratory medications)6-7
5) Movement of the patient from one setting or service to another8
6) Look-alike and unlabeled connectors/jacks1, 9
California Legislation Effective in 2014
California legislators signed into law a bill prohibiting the use of intravenous, epidural,
or enteral feeding connections that fit into connection ports other than the type
for which it was intended, unless an emergency or urgent situation exists and the
prohibition impairs delivering healthcare.23 The law takes effect no later than January
It is becoming
increasingly important
for healthcare facilities
to proactively address
inadvertent tubing
misconnections and
1, 2014. The World Health Organization’s (WHO) World Alliance for Patient Safety
prepare for device
and the Collaborating Centre include catheter and tubing misconnection avoidance
changes that will
among nine effective solutions to reduce the toll of healthcare related harm that affect
millions of patients worldwide.24
eventually reach
clinical settings. International Standards
The Association for the Advancement of Medical Instrumentation (AAMI),
the International Organization for Standardization (ISO) and the International
Electrotechnical Commission (IEC) contributed to the international standard to
assess non-interconnectability characteristics of small-bore connections used in the
development of intravascular, breathing systems, enteral/gastric, urethral/urinary, limb
cuff inflation and neuraxial devices.15, 26-28 Entitled “Small-bore connectors for liquids
and gases in healthcare applications” (ANSI/AAMI/ISO 80369-1:2010), the standard
would establish engineering “forcing functions” that would strive to eliminate the
possibility of misconnections. If the FDA recognizes the standard, the Agency will
provide guidance to manufacturers regarding issues such as whether there will be
a set period of time for currently marketed devices to come into compliance and the
effect of the standard on new devices.15
2
Program Overview
With both the healthcare manufacturers and advocacy groups focused on this
issue, it is becoming increasingly important for healthcare facilities to proactively
address inadvertent tubing misconnections and prepare for device changes that will
eventually reach clinical settings.
Types of Misconnections
The following are examples of the types of tubes and catheters in misconnections
based on reports of actual events or near misses by the USP, ISMP, TJC, ECRI,
and FDA:
1. Neuraxial — Vascular12
• Epidural infusion administration set connected to injection port of IV
infusion administration set or IV catheter
• IV administration set used for epidural infusion connected to IV catheter or
injection port of IV infusion administration set
• Syringe containing neuraxial medication (e.g. analgesics and anesthetics)
connected to IV catheter or injection port of IV infusion administration set
2. Topical — Vascular9
• IV administration set used with an infusion device for wound management
to deliver a topical wound irrigation solution connected to injection port of
IV infusion administration set
• IV administration set connected to port of topical wound irrigation set
3. Bladder (Urinary) Irrigation — Vascular16
• IV administration set used for bladder irrigation connected to IV catheter
or injection port of IV infusion administration set
• IV infusion administration set connected to an indwelling Foley catheter
inflation port
4. Medical Device — Vascular14, 16
• Sequential compression device hose connected to injection port of IV
infusion administration set or IV catheter
• Pneumatic blood pressure cuff tubing connected to injection port of IV
infusion administration set
• Oxygen tubing connected to injection port of an IV infusion
administration set
• Syringe containing air for indwelling Foley catheter inflation port connected
to injection port of IV infusion administration set
3
Program Overview
5. Respiratory — Vascular4
• IV administration set connected to injection port of administration set
attached to a respiratory therapy (RT) nebulizer
• IV administration set connected to RT nebulizer
• Syringe containing parenteral medication connected to injection port of
administration set attached to RT nebulizer.
6. Hemodialysis/Peritoneal Dialysis — Vascular8
• Peritoneal dialysis solution administration set connected to IV injection port of
IV infusion administration set or IV catheter
• IV infusion administration set connected to external hemodialysis catheter
7. Enteral/Oral — Vascular6, 13
• Enteral feeding tubing connected to IV catheter or injection port of IV
administration set
• Enteral feeding tubing connected to IV catheter or injection port of IV infusion
administration set
• Syringe containing parenteral medication connected to Y-connector port of
enteral administration set
• IV infusion administration set connected to Y-connector port of enteral
administration set
• IV infusion administration set connected to enteral feeding tubing,
percutaneous feeding tube, and/or nasogastric tube
8. Enteral/Oral — Medical Device8, 16, 20
• Enteral feeding tubing connected to a tracheostomy tube
• Enteral feeding tubing connected to ventilator in-line suction catheter
• Foley catheter connected to nasogastric tube
9. Enteral/Oral — Hemodialysis/Peritoneal Dialysis8
• Enteral feeding tubing connected to peritoneal dialysis catheter
• Enteral feeding tubing connected to a port on a hemodialysis line
10. Intravenous — Arterial8, 16
• IV infusion administration set connected to injection port of arterial infusion
administration set
• Syringe of IV medication connected to injection port of arterial infusion
administration set
• Arterial infusion administration set connected to IV catheter or injection port
of IV administration set
4
Program Overview
Other medical tubing, catheters, and connectors with the potential for
misconnections include:
• Abdominal catheter (e.g. t-tube, wound drainage tube)
• Blakemore tube
• Cantor tube
• Chest tube
• Cranial catheter
• In-line or detachable suction tubing/connector
• Intra-aortic balloon pump (IABP) tubing
• Nephrostomy tube
• Amnioinfusion catheter (intrauterine pressure)
• Ventriculostomy catheter
• Drain
Graphic depictions of misconnection cases have been compiled by the FDA and
coupled with TJC on ways to prevent these types of errors. Photographs show
simulated “erroneous misconnections” to illustrate the reported error. Photographs
have warning labels, where appropriate, to indicate that they are erroneous
connections. These may be found at http://www.fda.gov/downloads/MedicalDevices/
Safety/AlertsandNotices/UCM134869.pdf16
www.fda.gov/cdrh/luer
U.S. Food and Drug Administration
eveNT
feeding tube erroneously
connected to trach tube
U.S. Food and Drug Administration
pOTeNTIaL fOR haRm
high
Case sTUDy
• An infant in the pediatric intensive
care unit had both a feeding tube
and a trach tube
WARnInG: Photographs depict feeding tube erroneously
connected to trach tube. DO nOT DO THIS!
• The feeding tube was inadvertently
placed in the trach tube and milk
was delivered into the infant’s lungs
• The infant died
eveNT
epidural tubing
erroneously connected
to Iv tubing
pOTeNTIaL fOR haRm
high
Case sTUDy
• An anesthetist and a midwife
mistakenly connected an epidural
set to the patient’s IV tubing
• The epidural medication
was delivered to the IV
• The patient died
The jOINT COmmIssION safeTy TIp
Always trace a tube or catheter
from the patient to the point of
origin before connecting any
new device or infusion
Medical
Device Safety Calendar 2009
The jOINT COmmIssION safeTy TIp
WARnInG: Photographs depict epidural tubing
erroneously connected to IV tubing. DO nOT DO THIS!
For certain high-risk catheters
(e.g., epidural, intrathecal,
arterial), label the catheter and
do not use catheters that have
injection ports
5
Program Overview
Self Assessment Rationale
The Tubing Misconnections Self Assessment for Healthcare Facilities will help you
identify devices and practices that pose a risk of inadvertent tubing misconnections
and help prioritize your efforts to mitigate those risks. The self-paced and selfdirected risk analysis can be tailored to your healthcare facility, specific at risk patient
populations, and the catheters, tubing, connectors, and syringes used in your facility.
Objectives
Upon completion of this self assessment, you will be able to:
• Identify and prioritize devices and practices vulnerable to tubing
misconnections.
• Establish processes and device selection guidelines to help safeguard
against misconnections.
Methodology
The self assessment guides users through a modified risk assessment. To complete the
analysis, users evaluate current delivery systems and mating devices, rate the ease of
connection and potential for patient harm, and assign risk priority scores.
Outcomes
Facilities using this self assessment and the available resources and recommendations
can expect to:
• Prioritize a list of at risk devices and processes.
• Identify strategies to minimize the risk of inadvertent tubing misconnections.
• Develop an action plan to implement strategies to help minimize the risk of
tubing misconnections.
For questions about this self assessment, please contact:
Center for One Baxter
(8 a.m. – 5 p.m., CST, Monday - Friday)
at 800-422-9837
or
e-mail [email protected].
6
Baxter Healthcare Corporation, Route 120 and Wilson Road, Round Lake, IL 60073, www.baxter.com 750432B 11/11
Process Flow
Pre-implementation
Planning
Determine awareness level of tubing misconnections risk.
Establish a multi-disciplinary committee.
Determine the scope of the assessment.
Use the Examples of Misconnection Types in the Program Overview
Section to help identify the devices for evaluation.
Data Collection
Test connections among the targeted devices.
Assign an Ease of Connection score.
Assign a Potential Harm score.
Calculate a Risk Priority Number (RPN).
Analysis & Interpretation
Enter the data from Ease of Connection and Potential Harm scores
recorded in the Data Collection Tool into the Data Collection
Spreadsheet.
Review the Risk Rating Graph and Data Collection Spreadsheet
Summary, prioritizing the risk, with consideration of the factors
identified in the Interpreting Findings section of this assessment.
Implementation
Use the findings from your risk assessment and analysis to develop an
action plan. Use the Action Plan Templates (found in Appendix C) to help
document and organize your institution’s risk of tubing misconnections.
Implementation
Baxter Healthcare Corporation, Route 120 and Wilson Road, Round Lake, IL 60073, www.baxter.com 750432C 11/11
7
Getting Started
T
Thoughtful preparation and attention to the process help yield both relevant results and
an attainable action plan. Following these suggestions and meeting the key milestones
outlined in the Process Flow will help you successfully use this tool and adapt it to the
needs of your institution.
First Steps
Achieving a successful outcome depends on participation and support from
all levels of hospital leadership, management, and staff. Gaining commitment
from your institution’s leadership early in the process, may help achieve
institutional support.
1.Meet with key members of your institution (including administrators, clinical
managers, patient care providers, risk managers, educators, and materials
management) to determine the level of awareness of tubing misconnections risk
in their respective departments.
2.Establish an interdisciplinary team to help assess misconnections in your
institution. Include representatives from the following areas/departments: Quality,
Risk Management, Patient Care Units, Anesthesia, Radiology, Pharmacy, Clinical
Education, IV Therapy Team, Respiratory Therapy, Biomedical/Clinical Engineers,
and Materials Management. Be sure to include frontline staff who routinely use
medical devices. Assign the organization’s patient safety officer, medication
safety officer, or other qualified professional to lead the team.
3.Determine the scope of the assessment based on your organization’s desired
objectives. While a system-wide assessment should be the aspired goal, resource
limitations may require several small scale assessments in targeted areas,
such as:
• Unit-specific (e.g. neonatal intensive care unit, emergency department,
medical-surgical, critical care, labor and delivery, oncology)
• Therapy-specific (e.g. enteral feedings, pain management)
• Facility-wide (for health systems with multiple facilities)
4.Based on the scope of the assessment, review the Types of Misconnections in
the Program Overview section to help determine which are available or potentially
available in the selected area(s) under evaluation. Additionally, consider any other
disposables and devices that are specific to your institution that are not included
on the list.
8
Getting Started
Next Steps
1.Confirm you have downloaded the Tubing Misconnections Self Assessment for
Healthcare Facilities Data Collection Spreadsheet – Appendix B, from
www.baxter.com.
Quick Tip:
2.Identify participating units.
3.Review the Ease of Connection and Potential Harm Severity Scales (below and in
Appendix A) with the assessment team.
When determining the
scores associated with Ease
4.Review the devices (e.g. tubing, syringes, catheters, connectors) that will be
of Connection and Potential
included in the assessment.
Harm, consider variables
5.Identify locations where the devices to be assessed are stored.
that may influence these
6.Gather targeted disposable devices for the team to assess.
scores, such as the types
7.Plan how the team will assess connections with devices that are not disposable,
of medications/solutions,
equipment that is not easily gathered, or devices that may be costly to open
the patient population, and
and manipulate.
the typical infusion rates.
8.Perform the assessment as described in the Data Collection section.
EASE OF CONNECTION x POTENTIAL HARM = RISK PRIORITY NUMBER
Ease of Connection Scale
1
Unable to connect
Unable to make connection even with extreme
manipulation, force, and/or damage or
modification to device;
Easy to see that devices not intended to be
connected
Potential Harm Severity Scale
1
No harm
2
Minor harm
2
Extremely difficult
to connect
Connection made with extreme manipulation,
force, and/or damage or modification to device
3
Low harm
3
Moderately difficult
Connection made with moderate manipulation,
force, and/or modification to device;
Connection made with no equipment damage
4
Moderate harm
Moderately easy
Connection made with minimal manipulation
and/or force
Connection made with no device modification
or damage;
Seemingly correct fit
4
5
Very easy
Perfect fit with no manipulation, force, or
device modification or damage;
Hard to detect misconnection
5
High Harm
No harm to patient
Minor harm to patient;
No intervention anticipated
Injury of limited extent or duration;
Minimal or no intervention anticipated
Injury significant and/or enduring
Intervention anticipated;
Injury not expected to impact quality of life and
life expectancy
Injury serious, may be life-threatening or
deadly;
Injury expected to diminish quality of life and
life expectancy
9
Baxter Healthcare Corporation, Route 120 and Wilson Road, Round Lake, IL 60073, www.baxter.com 750432D 11/11
Data Collection
Instructions
1.Gather the Tubing Misconnections Data Collection Tool (Appendix A), which includes the
Ease of Connection Scale and the Potential Harm Severity Scale, and the targeted devices
(as possible). It is suggested that potential connections be grouped by the Connection Type.
2.Test connections among the targeted devices (e.g. tubing, syringes, connectors, catheters). Be sure
to assess connectivity if devices can be connected in unintended ways or by means of jury-rigging or
significant device manipulation.
3.Using the Ease of Connection Scale, rate the extent of force, manipulation, and/or device modification
or damage required to make the connection.
4.Using the Potential Harm Severity Scale, rate the severity of potential patient harm that would result if
the connection is made.
Please note: Only device connections that were assessed a score of “2” or above for Ease of
Connection should be given a Potential Harm Severity score. Device connections that scored
“1” on Ease of Connection — meaning the connection cannot be made despite extreme force or
manipulation — do not require a Potential Harm score.
5.Document the results using the Data Collection Tool.
6.Calculate the Risk Priority Number (RPN) by multiplying the Ease of Connection and Potential Harm
Scores. Add pertinent comments regarding frequency of use and current unit-specific or organizationwide safety practices associated with the devices. (See the following examples.)
Examples
Connection Type: IV Tubing
Connection Type: Blood pressure/Tube
Mating Device: Respiratory Nebulizer
Mating Device: Venous Injection Port
Patient Care Area: ICU
Ease of Connection
3
Patient Care Area: All nursing units that administer IV solutions
Potential Harm
x
4
Risk Priority Number
=
12
Ease of Connection
4
Potential Harm
x
5
=
20
Frequency of Use: Daily on post-op orthopedic surgeries
Frequency of Use: Daily
Comments:
A 2 RN check is required before connection.
Comments:
There is variability in the blood pressure equipment (NIBP).
Only model #124 mates with the valve on IV tubing.
10
Baxter Healthcare Corporation, Route 120 and Wilson Road, Round Lake, IL 60073, www.baxter.com 750432E 11/11
Analysis
Instructions
1. Open the Data Collection Spreadsheet (Appendix B) and enable the macros in Excel per the
instructions on the first worksheet.*
2.Enter the data you’ve recorded from the Data Collection Tool (Appendix A) into the spreadsheet.
3.After entering the data, the spreadsheet will:
■■
alculate the Risk Priority Number (RPN)
C
Ease of Connection x Potential Harm = RPN
■■
Generate a Risk Rating Graph
■■
Provide a Data Collection Summary
4.Review the graphs and Summary rankings to prioritize risk.
*Note: The System Requirements to run the Data Collection Summary Spreadsheet are a WINDOWS PC
with Office 2003 or Office 2007. This application is not compatible with MACINTOSH systems.
Interpreting Findings
1.The Risk Rating Graph provides a visual expression of the connection types
posing risk in your institution. Pay close attention to:
• Circles in the upper right, which represent connection types that are
easy to make and pose a risk to patients (RPN 15 to 25).
• Circles in the upper left, which represent connection types that are
not easy to make but still pose a risk to patients (RPN less than 15).
2.The Data Collection Summary ranks the Risk Priority Numbers from highest to
lowest. Note which connection types have received higher rankings. This may
help in prioritizing risk and developing your action plan.
3.After reviewing the findings, consider the following when prioritizing the risk within
your institution:
• Frequency of using the devices
• Reported events or near misses within your institution
• Reports of events or near misses in the literature8
• Detection and prevention strategies already in place to reduce the risk of
misconnections, and the anticipated effectiveness of those strategies
11
Analysis
• Unique institutional variables, including:
■■
High staff turnover
■■
Significant number of per diem/traveling nurses
■■
Presence of students in a teaching facility
■■
Staff shared between units/floating nurses
■■
Use of rental equipment
■■
Experience with device shortages
■■
Absence of dedicated in house transport team
12
Baxter Healthcare Corporation, Route 120 and Wilson Road, Round Lake, IL 60073, www.baxter.com 750432F 11/11
Action Plan
Instructions
Use the findings from the risk assessment and analysis to develop an action plan to increase staff awareness
and help reduce the risks of tubing misconnections. The action plan could include:
• Barriers that prevent tubing misconnections
• Implementation of redundancies to help prevent misconnections before they lead to patient harm
• Recovery strategies to help reduce harm caused by tubing misconnections
• Equipment maintenance plans
• An educational campaign to increase awareness
• Product selection guidelines
• Development of a tubing misconnections prevention policy for the institution
• Process to further review current devices and future device acquisitions
Provide the risk assessment findings and action plan to hospital administration for support in promoting
activities presented in the action plan.
Use the Action Plan Template (Appendix C) to help document and organize your institution’s risk of tubing
misconnections.
Risk Reduction Strategies
TJC30, ISMP13, USP30, ECRI1, FDA16, WHO25, A.S.P.E.N.30 and other patient safetyfocused organizations33 and researchers29 offer the following strategies to help
mitigate the risk of tubing misconnections. Organizations are encouraged to review
the following recommended risk reduction strategies during the development of an
action plan to address tubing misconnections:
Use Forcing Functions
(designs that strive to eliminate the possibility of misconnections)
• Use only oral syringes for oral liquid medications. Never use a standard
Luer syringe for oral medications or enteric feedings.30
• Use only oral syringes for enteral medications or solutions.30
• Use only administration sets without injection ports for epidural infusions.1
• Purchase non-intravenous devices (e.g. nebulizers, NIBP) that are
equipped with connectors that cannot physically mate with a female Luer
IV line connector.1
• Purchase enteral feeding sets and gastrointestinal tubes that do not
mate with female Luer connectors (e.g. compliant with American
National Standards Institute/Association for the Advancement of Medical
Instrumentation [ANSI/AAMI] standard ID54).1, 13, 30
13
Action Plan
• If possible, use enteral pumps that feature an automatic flush mode
so manually flushing lines is not required (which makes it less likely for
staff to use an adapter that links the enteral administration set with a
Luer connector).1
• Avoid buying pre-filled enteral feeding containers, except for those with
design technology labeled non–IV compatible. This technology, just
recently introduced in the United States, uses a screw-top design that
reduces compatibility with IV equipment.30
• When appropriate, purchase devices with connectors that have locking
mechanisms to keep the connection secure.1
Use Differentiation
• Dispense intrathecal medications in overwraps that help differentiate these
syringes and bags from other medications intended for IV administration.12
• Dispense IV vincristine in a small volume bag to differentiate it from
syringes used for intrathecal medications.12
• Use only tubing without injection ports for epidural infusions to distinguish
it from typical IV tubing.1, 8, 12 Yellow striped tubing must only be used for
epidural infusions.
• Use distinctly different pumps for IV delivery and epidural delivery of
medications/solutions.12, 14
Provide Reminders
• Purchase products with warning labels or deliberate differentiating
markings when possible (e.g. oral syringes that are tinted and labeled
“For Oral Use Only”).1, 30
• Place labels (indicating what the port/line is being used for) on distal ports
and tubing of certain high risk access lines, such as epidural, intrathecal,
and arterial lines.8, 13, 14 (A neon sticker stating “Epidural” is often included
in special epidural administration sets.)
• Label pumps and bags used to deliver epidural medications as
“EPIDURAL ONLY.”8, 12, 14
• Label enteral pumps as “ENTERAL ONLY.”30
Improve Access to Information and Tools
• Always hang infusion bags with labels facing out so they can be read.
Make sure labels are on the same side of the infusion that includes any
other important preprinted information.12, 14
• Supply all clinical areas with oral syringes, and ensure staff is thoroughly
familiar with the design and purpose of all syringes and their important
safety features, particularly their inability to be connected to IV or other
male Luer ports.13
14
Action Plan
• Report all misconnections in accordance with your institution’s
guidelines—even those that are caught before harm occurs—to clinical
engineering, the patient safety officer, risk management, the device
manufacturer, ISMP (https://www.ismp.org/orderForms/reporterrortoISMP.
asp) and ECRI (www.ecri.org/problemreport). (ISMP shares all reports with
the FDA, anonymously, if desired.)1, 12, 14, 16-18
• Ensure that the appropriate administration set is packaged with
medication infusions and enteral feeding bags before they are sent
to/stocked in patient care units.1, 3, 6
• Purchase adequate numbers of enteral pumps so that IV pumps are not
needed for delivery of enteral products.30, 35-36
Improve Environmental Performance Shaping Factors
• Turn on the light in a darkened room or use a flashlight before connecting
or reconnecting tubes or other devices. 8, 14
• Place infusion pumps on opposite sides of the bed when administering
infusions via different routes of administration. When possible, do not keep
them next to each other or place them on the same pole.8, 12, 14
• Route tubes and catheters that have different purposes in different
standardized directions (e.g. IV lines routed toward the patient’s head,
enteral lines routed toward the patient’s feet).1, 30
Verify During Connection
• When connecting any new device or product, always trace the
connection port on the tube or catheter to the point of origin or entry
into the patient.1, 3-14, 16-19, 22, 24, 25, 30-34
• Ensure that all device connections are secure when making a connection
or reconnection.1
Implement Redundancies to Help Prevent Misconnections
• Require an independent double check at the bedside of all epidural
medications and selected high alert IV medications (e.g. IV opioids)
to verify correct line attachment before administration.12, 14
• Upon arrival at a new setting or as part of a handoff process, develop a
standardized “line reconciliation” process to recheck all connections and
trace all patient tubes and catheters to their source. If not already done,
label all tubes and catheters at the point(s) of connection.1, 8, 30
Recovery Strategies to Help Reduce Harm
• Develop resuscitation protocols to treat toxicity associated with
administration of drugs by the wrong route.12, 14
• Establish a policy that states the course of action to follow if a line
disconnects in an area without a qualified licensed practitioner present
to reconnect the line.
34
15
Action Plan
Equipment Maintenance Plans1
• Ensure that all clinical engineering staff performing equipment repairs
are aware of tubing misconnection issues, and that they avoid modifying
devices in ways that might facilitate misconnections.
• During testing of new equipment, require clinical engineering staff to look
for conditions that might invite misconnections with medical devices, and
to report these conditions to risk management so they can be addressed.
• During inspection and preventive maintenance procedures, require clinical
engineering to assess all fittings and replace worn connectors to ensure
that safety mechanisms are functional.
Education and Awareness
M ISCONNECTIONS
• Implement an ongoing campaign designed to educate all clinical and nonclinical staff about the dangers of tubing misconnections. The educational
campaign should be initiated during orientation and reinforced periodically
FOR PATIENT
SAFETY
Please contact staff member
in training curricula for all staff, including per diem and temporary staff.
for assistance with connecting
Include education regarding:
wires, equipment or devices .
or disconnecting any tubing,
 Types of medical devices used in your facility and their
intended purposes1
 Causes of tubing misconnections12, 14
 Potential serious consequences that could result from tubing
misconnections1, 8, 12, 14
 Examples of actual tubing misconnections that have occurred
in the organization and in other organizations, as reported in
the literature1, 8, 16, 30
M ISCONNECTIONS
 Personnel that is authorized to connect, reconnect, and
disconnect medical devices1, 5, 8
 Instruction for non-authorized staff, patients, and their families to
call for assistance from the clinical staff in the case of accidental
disconnections or if other concerns regarding a patient’s device or
infusion connections arise.1, 5, 8, 34
 Refusals of requests to connect or disconnect medical tubing
when it is not in a staff member’s scope of practice5, 34
” C HECK B EFORE Y OU C ONNECT”
 Prohibition of device modification (e.g. cutting off tip of tubing),
adaptation, use of force, jury rigging, or manipulations that could
compromise device safety features in order to create a makeshift
connection between devices1, 6-8, 12, 14, 34, 35
16
Action Plan
 Enforcement of key risk prevention strategies, including a firm
policy on tracing tubes and catheters to point of origin before
connections are made, and labeling of intravenous, PCA, epidural,
intrathecal, and arterial lines.1, 6-14, 34, 35
 Assumption that two pieces of tubing connect because of
matching adapters or “standard/familiar” tubing types
FRONT
34
• Use tubing misconnections simulation training during orientation and
MISCONNECTIONS
annual safety competencies.14, 16, 18, 19
• Inform patients and their families that they must notify clinical staff
whenever there is a real or perceived need to connect or disconnect
tubing or other devices.8, 34
• Explain the purpose of each piece of tubing, line, or other device to the
patient and family so they can also monitor for unintended variation.34
• Provide staff and patients with posters, brochures, or other informational
pieces that communicate the dangers of potential tubing misconnections
and strategies for preventing them.34 (Free posters are available at: http://
www.americannursestrainingassociation.com/tubing%20misconnections.
[email protected]
html#q4)
IN
• Provide education to staff before using new syringes, tubes, catheters,
or connectors. Include discussion about possible sources of errors
uncovered during an initial risk assessment and steps to avoid
these errors.14
• Ensure that staff receives training from the manufacturer before using
new equipment so they know how to use it correctly and understand
its safeguards.1
Product Review and Selection Guidelines
• Establish a device selection policy to ensure that, whenever possible, only
devices with effective design solutions are purchased and used in patient
care areas. Formalize an internal review process for all new acquisitions
1
of devices with connectors to identify the potential for misconnections with
existing syringes, catheters, tubes, and connectors.1, 8, 30 Do not permit
“special order” items to bypass the internal review process.
• Conduct pre-purchase evaluations in which device users can “play” with
DON’T BE
CHECK BEFORE
Nursing Interventions
To Prevent
Misconnections:
1. Always trace a tube or catheter
from the patient to the point of
origin before connecting any new
device or infusion.
2. Line reconciliation: Recheck
connection & trace all patient
tubes & catheters to their sources
upon the patient’s arrival to a
new setting or service as part of
the hand-off process.
3. Label epidural, intratheral and
arterial catheters.
- ‫ ܀‬-
the device to uncover misconnection hazards before purchasing and
using the devices. (Refusal to purchase unsafe equipment will also drive
manufacturers to create better designed devices.)1
• In general, avoid buying devices with connectors for functions that are
interchangeable or look like other connectors that serve different functions.1
• Limit and standardize the number and types or brands of the same
devices when possible.8
17
Action Plan
Additional Risk Reduction Strategies
• Staff members who are allowed to connect, disconnect, or reconnect
medical tubing should be limited to those who have received institution
approved healthcare training and education on safety measures regarding
the serious risks associated with misconnections.5
• In each staff member’s job description, define whether the task of
performing connections and disconnections of tubing falls within a safe
and acceptable scope of practice. Be specific regarding technicians who
work in diagnostic areas, transport staff, nursing assistants, and students,
who might routinely encounter this situation.34
Quick Tip:
• Avoid using dual channel pumps for infusions via different routes
of administration.12
• Limit the frequency of disconnecting and reconnecting tubing (particularly
IV tubing) to reduce the risk of misconnections and infections.14
• Remove adapters and connectors from care areas where they are not
essential to reduce the likelihood of work arounds, jury rigging, and
improper connections. Remind staff that the need for an adapter could
signal that the connection should not be made.1, 30
To keep pace with the
changes at your institution,
make the self assessment
for tubing misconnections
an ongoing process.
• When possible, use connector designs (e.g. locking connectors) that
reduce the risk of disconnections.1
• Store medications for different routes of administration in different
locations.12, 30
• Deliver and administer one time doses of intrathecal medications in an
area separate from any other medications, particularly IV medications. In
low volume use areas, dispense epidural medication immediately before
use and hand it to an authorized clinician. In high volume areas, place the
medication immediately in the appropriate storage locations.12
• Dispense oral liquid medications from the pharmacy when possible in unitof-use oral syringes.13
• Nasogastric tubes should be connected only to oral syringes via
enteral syringe extension sets (non-Luer syringe extension sets for
enteral feeding).6
18
Action Plan
Monitoring and Revising the Self Assessment
• Minimizing tubing misconnections requires monitoring of established
procedures and protocols.
• Establish a procedure for reviewing the results of the self assessment and
established action plan.
Note: It is the responsibility of the healthcare providers to report any adverse events/
complaints to the FDA and manufacturers.
The Action Plan is a dynamic document that should reflect changes in regulatory
guidance and new product acquisitions, as well as educational requirements of
clinical staff to maintain a high level of awareness. The self assessment should be
conducted at appropriate intervals in keeping with changing hospital dynamics.
For questions about this self assessment, please contact:
Center for One Baxter
(8 a.m. – 5 p.m., CST, Monday - Friday)
at 800-422-9837
or
e-mail [email protected].
19
Baxter Healthcare Corporation, Route 120 and Wilson Road, Round Lake, IL 60073, www.baxter.com 750432G 11/11
Legal Disclaimers
• The information published in this Self Assessment is for general and educational
purposes only. This information is not meant to be construed as medical advice,
diagnosis or treatment. No action or inaction should be taken based solely on
the information provided in this Self Assessment. Baxter, in collaboration with the
Institute for Safe Medication Practices (ISMP), has made all reasonable efforts to
ensure that all of the information provided through this Self Assessment is accurate
at the time of the inclusion; however Baxter and ISMP make no assurances as
to the accuracy, currency or completeness of the content provided in this Self
Assessment.
• THIS SELF ASSESSMENT IS PROVIDED “AS IS.” BAXTER AND ISMP MAKE NO
REPRESENTATIONS OR WARRANTIES AS TO THE INFORMATION OR MATERIALS
PROVIDED IN THIS SELF ASSESSMENT. YOU EXPRESSLY AGREE THAT YOUR
USE OF THIS SELF ASSESSMENT IS AT YOUR SOLE RISK. BAXTER AND ISMP
DISCLAIM ALL WARRANTIES, EXPRESS OR IMPLIED, INCLUDING BUT NOT
LIMITED TO, IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A
PARTICULAR PURPOSE.
• Neither Baxter nor ISMP shall be liable for any indirect, special, incidental,
consequential or punitive damages, arising out of the use of this Self Assessment.
By using this Self Assessment you agree to the exclusions and limitations of liability
stated above and accept them as reasonable.
20
Appendix A
Data Collection Tool
21
Baxter Healthcare Corporation, Route 120 and Wilson Road, Round Lake, IL 60073, www.baxter.com 750432H 11/11
Appendix A
EASE OF CONNECTION x POTENTIAL HARM = RISK PRIORITY NUMBER
Ease of Connection Scale
1
Unable to connect
Unable to make connection even with extreme manipulation,
force, and/or damage or modification to device;
Easy to see that devices not intended to be connected
2
Extremely difficult
to connect
Connection made with extreme manipulation, force, and/or
damage or modification to device
3
Moderately difficult
Connection made with moderate manipulation, force, and/or
modification to device;
Connection made with no equipment damage
Moderately easy
Connection made with minimal manipulation and/or force
Connection made with no device modification or damage;
Seemingly correct fit
4
5
Very easy
Perfect fit with no manipulation, force, or device modification
or damage;
Hard to detect misconnection
Potential Harm Severity Scale
1
No harm
2
Minor harm
3
4
5
Low harm
Moderate harm
High harm
No harm to patient
Minor harm to patient;
No intervention anticipated
Injury of limited extent or duration;
Minimal or no intervention anticipated
Injury significant and/or enduring
Injury not expected to impact quality of life and
life expectancy
Injury serious, may be life-threatening or deadly;
Injury expected to diminish quality of life and life expectancy
22
Appendix A
P OT EN T I A L
C O N N EC T I O N S
Connection Type:
Connection Type:
Mating Device:
Mating Device:
Patient Care Area:
Patient Care Area:
Ease of Connection
Potential Harm
x
=
Ease of Connection
Frequency of Use:
Frequency of Use:
Comments:
Comments:
Connection Type:
Connection Type:
Mating Device:
Mating Device:
Patient Care Area:
Patient Care Area:
Ease of Connection
Potential Harm
x
=
Ease of Connection
Frequency of Use:
Frequency of Use:
Comments:
Comments:
Connection Type:
Connection Type:
Mating Device:
Mating Device:
Patient Care Area:
Patient Care Area:
Ease of Connection
Potential Harm
x
=
Ease of Connection
Frequency of Use:
Frequency of Use:
Comments:
Comments:
Potential Harm
x
=
Potential Harm
x
=
Potential Harm
x
=
Appendix A
P OT EN T I A L
C O N N EC T I O N S
Connection Type:
Connection Type:
Mating Device:
Mating Device:
Patient Care Area:
Patient Care Area:
Ease of Connection
Potential Harm
x
=
Ease of Connection
Frequency of Use:
Frequency of Use:
Comments:
Comments:
Connection Type:
Connection Type:
Mating Device:
Mating Device:
Patient Care Area:
Patient Care Area:
Ease of Connection
Potential Harm
x
=
Ease of Connection
Frequency of Use:
Frequency of Use:
Comments:
Comments:
Connection Type:
Connection Type:
Mating Device:
Mating Device:
Patient Care Area:
Patient Care Area:
Ease of Connection
Potential Harm
x
=
Ease of Connection
Frequency of Use:
Frequency of Use:
Comments:
Comments:
Potential Harm
x
=
Potential Harm
x
=
Potential Harm
x
=
Appendix B
Data Collection Spreadsheet
Please refer to the downloaded Excel spreadsheet.
(See page 9, step 1, of this assessment.)
25
Baxter Healthcare Corporation, Route 120 and Wilson Road, Round Lake, IL 60073, www.baxter.com 750432I 11/11
Baxter Healthcare Corporation, Route 120 and Wilson Road, Round Lake, IL 60073, www.baxter.com 750432J 11/11
Action Plan Templates
Appendix C
26
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REDUNDANCIES TO HELP PREVENT MISCONNECTIONS
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RECOVERY STRATEGIES TO HELP REDUCE HARM
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EQUIPMENT MAINTENANCE PLANS
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EDUCATION PLAN TO INCREASE AWARENESS
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PRODUCT SELECTION GUIDELINES
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DEVELOPMENT OF A PREVENTION POLICY
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Appendix D
References
1)ECRI. Preventing misconnections of lines and cables. Health Devices.
2006;35(3):81-95. https://www.ecri.org/Documents/Patient_Safety_Center/
Preventing_Misconnections_of_Lines_and_Cables.pdf
2)Clark D. (1994). Untangling the “spaghetti syndrome” — inspiration for a
business. Revolution; 4(4): 55-56.
3)Cook TM, Seavell CR. (1996). Patient transfer; what to do about the “spaghetti”.
Anaesthesia; 51(1): 90-91.
4)ISMP. Problem persists with life-threatening tubing misconnections. ISMP
Medication Safety Alert! 2004;9(12):1-2. http://www.ismp.org/newsletters/
acutecare/articles/20040617.asp
5)ISMP. Worth repeating…IV tubing misconnected to tracheostomy collar. ISMP
Medication Safety Alert! 2007;12(12):1-2
6)ISMP. Preventing accidental IV infusion of breast milk in neonates. ISMP
Medication Safety Alert! 2006;11(12):1-2.
7)ISMP. Questionable safety with continuous inhalation albuterol infusion set-up.
ISMP Medication Safety Alert! 2010;15(11):1-2.
8)The Joint Commission. Tubing misconnections — a persistent and potentially
deadly occurrence. Sentinel Event Alert. 2006;36:1-4. http://www.premierinc.
com/quality-safety/tools-services/safety/topics/tubing-misconnections/
downloads/jcaho-sentinel-event-issue-36.pdf
9)ISMP. Dakin’s solution accidentally given IV. ISMP Medication Safety Alert!
2010;15(21):1-2.
10)ISMP. Blood pressure monitor tubing may connect to IV ports. ISMP Medication
Safety Alert! 2003;8(12):1-2.
11)Needham DM, Sinopoli DJ, Thompson DA et al. (2005). A system factors
analysis of “line, tube and drain” incidents in the intensive care unit. Crit Care
Med; 33(8): 1701-1707.
12)ISMP. Epidural-IV route mix-ups: reducing the risk of deadly errors. ISMP
Medication Safety Alert! 2008;13(13):1-3.
13)ISMP. Oral syringes: a crucial and economical risk-reduction strategy that has
not been fully utilized. ISMP Medication Safety Alert! 2009;1(21):1-3.
14)ISMP. Preventing catheter/tubing misconnections: much needed help is on the
way! ISMP Nurse Advise-ERR. 2010;8(12):1-2.
34
Appendix D
References
15)FDA. Letter to manufacturers of enteral feeding tubes. July 9, 2010.
http://www.premierinc.com/quality-safety/tools-services/safety/topics/tubingmisconnections/downloads/FDA-Enteral-Feeding-Tube-Letter.pdf
16)FDA. Look. Check. Connect. Medical device safety calendar 2009. Available
at: http://www.premierinc.com/quality-safety/tools-services/safety/topics/tubingmisconnections/downloads/FDA-Medical-Device-Calendar-2009.pdf
17)FDA. Luer misconnections. Medical Devices. Available at: http://www.fda.gov/
MedicalDevices/Safety/AlertsandNotices/ucm134863.htm
18)FDA. Luer lock misconnections can be deadly. Patient Safety News. December
2005. http://www.premierinc.com/quality-safety/tools-services/safety/topics/
tubing-misconnections/downloads/fda-luer-lock-misconnections.pdf
19)FDA. More patient deaths from Luer misconnections. Patient Safety News.
October 2007. http://www.accessdata.fda.gov/psn/transcript.cfm?show=68#5
20)Hicks R, Provan LN. Preventing tubing misconnections: a practical view.
Safe Practices in Patient Care. 2009;3(2):2-8. http://www.safe-practices.org/
SafePractice8.pdf
21)The Joint Commission. Summary data of sentinel events reviewed by The Joint
Commission. December 2010. http://www.jointcommission.org/assets/1/18/
SE_Data_Summary_4Q_2010_(v2).pdf
22)FDA. Luer connector misconnections: under-recognized but
potentially dangerous events. Webcast. FDA and Beaumont Hospital.
November 19, 2008. http://www.fda.gov/MedicalDevices/Safety/
MedSunMedicalProductSafetyNetwork/ucm127745.htm
23)California Assembly Bill (AB) 818 (Hernandez, Chapter 476, Statutes of 2009).
http://www.cdph.ca.gov/certlic/facilities/Documents/LNC-AFL-09-41.pdf
24)World Health Organization (WHO). WHO launches ‘nine patient safety solutions.’
May 2, 2007.
http://www.who.int/mediacentre/news/releases/2007/pr22/en/index.html
25)World Health Organization, The Joint Commission, Joint Commission
International. Avoiding catheter and tubing mis-connections. WHO
Collaborating Center for Patient Safety Solutions. May 7; 1(7): 1-3. http://www.
ccforpatientsafety.org/common/pdfs/fpdf/presskit/PS-Solution7.pdf
26)Association for the Advancement of Medical Instrumentation (AAMI). ISO/IEC
small bore connector new work proposal package including contact information.
August 2006. http://www.aami.org/Applications/CommitteeCentral-app/
Documents/SBC_PA.pdf
35
Appendix D
References
27)International Organization for Standardization (ISO). ISO/CD 80369-1. Updated
2008. http://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_detail.
htm?csnumber=45976
28)Standards to focus on tubing misconnections. Healthcare Purchasing
News. October 2008. http://www.hpnonline.com/inside/2008-10/0810-orgowns&drapes.html
29)Lovell MA, Mudaliar MY, Klineberg PL. (2001). Intra-hospital transport of
critically ill patients: complications and difficulties. Anaesth Intensive Care; 4:
400-405.
30)Guenter P, Hicks RW, Simmons D, Crowley J, et al. Enteral feeding
misconnections: a consortium position statement. J Com J on Qual and Patient
Safety. 2008;34(5);285-292. http://www.premierinc.com/quality-safety/toolsservices/safety/topics/tubing-misconnections/downloads/S5-JQPS-05-08guenter.pdf
31)Hicks R, Pratt N, Simmons D. Panel discussion: tubing misconnections: where
are we today? Safe Practices in Patient Care. 2010;4(2):2-3. http://www.safepractices.org/SafePractice11.pdf
32)National Patient Safety Agency. Neuraxial update. February 2001;2:1-5.
http://www.nrls.npsa.nhs.uk/resources/patient-safety-topics/medical-deviceequipment/?entryid45=94529
33)Gallauresi B, Eakle M, Morrison A. Misconnections between medical devices
with Luer connectors: under-recognized but potentially fatal events in clinical
practice. Safe Practices in Patient Care. 2009;3:1,4-8. http://www.safe-practices.
org/SafePractice8.pdf
34)American Nurses Training Association. Tubing misconnections. 2007.
http://www.americannursestrainingassociation.com/tubing%20misconnections.
html#q4
35)ISMP. Improvised drug delivery: a cause for concern. ISMP Medication Safety
Alert! 2004;9(8):1-2.
36)ISMP. Worth repeating. ISMP Medication Safety Alert! 2003;8(6):2.
37)Jones S.A., Guenter P.: Automatic flush feeding pumps: A move forward in
enteral nutrition. Nursing 27:56–58, Feb. 1997.
38)Pennsylvania Patient Safety Authority. Tubing Misconnections: Making the
Connection to Patient Safety. Vol. 7, No 2-June 2010; 41:45.
36
Baxter Healthcare Corporation, Route 120 and Wilson Road, Round Lake, IL 60073, www.baxter.com 750432K 11/11

Tubing Misconnections Self Assessment for Healthcare Facilities

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