Document 6423831

Transcription

Document 6423831

Title
Breast Screening Programme Dataset (KC63 and KC62) Standard Specification
Document ID
ISB 1597
Sponsor
Jane Allberry
Status
Final
Developer
Sarah Sellars
Version
1.0
Author
Ginny Fieldsend
Version Date
29/08/2013
Breast Screening Programme Dataset (KC63 and
KC62) Standard Specification
© Information Standards Board for Health and Social Care 2013
29/08/2013 <1.0>
Amendment History:
Version
0.1
0.2
0.3
0.4
0.5
0.6
1.0
Date
rd
3 April 2013
Amendment History
First draft for comment
th
Updated following meeting with ISB
th
Updated following teleconference with ISM
th
Updated following appraisers comments
25 April 2013
29 May 2013
24 June 2013
rd
Updated following meeting with appraisers
th
Updated following comments from the ISB Knowledge Manager
3 July 2013
9 August 2013
th
29 August 2013
Updated following comments from ISB
Approvals:
Name
Organisation
Version
Date
Prof Julietta Patnick
NHS Cancer Screening Programmes
0.1
3 April 2013
0.2
25 April 2013
0.3
29 May 2013
0.4
24 June 2013
0.5
3 July 2013
0.6
9 August 2013
0.1
3 April 2013
0.2
25 April 2013
0.3
29 May 2013
0.4
24 June 2013
0.5
3 July 2013
0.6
9 August 2013
0.1
3 April 2013
0.2
25 April 2013
0.3
29 May 2013
0.4
24 June 2013
0.5
3 July 2013
0.6
9 August 2013
1.0
29
Richard Winder
Sarah Sellars
rd
th
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rd
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th
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August 2013
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Glossary of Terms:
Term
Acronym
Definition
Breast Assessment
Where breast screening has identified a potential abnormality,
women are recalled for further assessment, which may include
clinical examination, further imaging, and non-operative biopsy.
This triple assessment process forms part of the NHS Breast
Screening Programme
Breast Screening
Routine systematic testing of asymptomatic women with the aim
of detecting breast cancers at an early stage, when they are
more treatable. The test for routine population screening in the
over 50s is mammography.
Breast
Screening Unit
BSU
There are 80 BSUs in England, which are responsible for the
delivery of breast screening programmes locally to a defined
population.
Connecting for Health
CfH
NHS Connecting for Health (NHS CFH) was part of the
Department of Health Informatics Directorate as it ceased to
st
exist from the 31 March 2013. Their role was to maintain and
develop the NHS national IT infrastructure.
Coverage
Date of First Offered
Appointment
DOFOA
Women are eligible for screening if they are in the screening
age range or in a specified high risk category and are not
ineligible due to bilateral mastectomy.
Eligible women
Health and Social
Care Information
Centre
HSCIC
Mammography
Screening
National Breast
The percentage of women in the population who are eligible for
screening at a particular point in time (this is done annually) who
have had a test with a recorded result at least once within the
screening round, i.e. in the previous 3 years. Currently,
coverage is best assessed using the 53-70 years old age group.
This is because eligible women will be first invited at some time
rd
before their 53 birthday. Similarly, all eligible 70 year old
women will have been invited in the previous 36 months.
This is the date of the first appointment for assessment at a
breast assessment clinic offered to a woman following the
woman’s screening appointment. This date may differ from the
date that the woman actually attends for her appointment at the
breast assessment clinic (Date of First Actual Appointment –
DOFAA). The DOFOA is used as a proxy for the date of
attendance for assessment as this ensures that the breast
screening units are not unfairly represented when women
change their own appointments. This is a well-known term
within the screening programme and is a standard definition.
NBSS
The Health and Social Care Information Centre is a data,
information and technology resource for the health and care
system, and plays a fundamental role in driving better care,
better services and better outcomes for patients.
X-rays of each breast which can detect irregularities in breast
tissue, which are too small to be felt either by the woman herself
or by a doctor and over time may show changes indicating
cancers.
This is the standard breast screening computer system used by
the 80 breast screening units in England for administration of
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Screening System
National Co-ordinating
Centre for the Physics
of Mammography
29/08/2013 <1.0>
screening and recording screening outcomes from the routine
invitations to screening.
NCCPM
The NCCPM is run on behalf of the NHS Breast Screening
Programme (NHSBSP) by the Medical Physics Department of
the Royal Surrey County Hospital.
The centre has a broad remit to provide scientific and technical
advice to the NHSBSP. This involves the setup and
management of information systems that enable NCCPM to
monitor the performance of the breast imaging equipment used
in the NHSBSP.
NCCPM initiates programmes of research leading to
improvements in how breast screening is provided by the NHS
and is a leading centre of expertise in this field.
The NCIN is a UK-wide initiative, working to drive improvements
in standards of cancer care and clinical outcomes by improving
and using the information collected about cancer patients for
analysis, publication and research.
National Cancer
Intelligence Network
NCIN
National Health
Applications &
Infrastructure Services
(System)
NHAIS
The NHAIS System is used by al primary care support agencies
in England to record the identity details of all English residents
currently registered with NHS GPs. There are 82 separate
NHAIS instances in England, each covering a specific local
region and linked electronically with the NHS Personal
Demographics Service. NHAIS patient registration data provides
the base used to calculate global sum payments to GPs and to
manage the call/recall of women for the NHS breast and
cervical screening programmes.
NHS Breast Screening
Programme
NHSBSP
The NHS Breast Screening Programme is a national screening
programme delivered by 80 local breast screening units in
England.
Primary Care
Organisations
PCO
Policy Research Unit
in Cancer Awareness,
Screening and Early
Detection
PRU
PCO is a generic term that covers both Primary Care Trusts
(PCTs) and Care Trusts. Primary care is the care provided by
the people that patients see first when they have a health
problem (e.g. doctors, dentists, opticians, pharmacists). PCTs
st
ceased to exist from 1 April 2013.
The PRU is dedicated to research on cancers screening,
symptom awareness and early diagnosis. Funding is provided
over five years by the Department of Health’s Policy Research
Programme. The remit of the PRU includes studies of: cancer
awareness and survival; GP response to cancer symptoms; the
benefits of the NHSBSP designed to identify good practice; and
assessment of interventions to enhance cancer awareness ,
improve access to screening and promote diagnosis at an
earlier stage.
Quality Assurance
Reference Centres
QARC
QARCs collect and collate data about the performance and
outcomes of the breast screening programme, organise quality
assurance visits, and provide support for the regional director of
quality assurance and the professional coordinators. The
reference centre is the first point of contact for information about
the breast screening programme in the region.
Review of Central
Returns
ROCR
The HSCIC has enhanced responsibilities under the Health &
Social Care Act (2012) to reduce the burden on frontline
services by acting as a “gateway” to bodies seeking to collect
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data. This is achieved through the ROCR process.
The Review of Central Returns (ROCR) process makes sure
that information demands on the NHS are minimised, fit with
current national health policies and are carried out in the most
efficient way without duplication. It covers the Department of
Health and its Arm's Length Bodies (ALBs).
Section 251 was established to provide a secure legal basis for
disclosure of confidential patient information for medical
purposes, where it was not possible to use anonymised
information and where seeking consent was not practicable,
having regard to the cost and technology available.
A short term (also previously known as “early recall”) recall is
defined as a further invitation to assessment. Short term recall
for screening at less than the routine screening is not
recommended. Short term recall is a new screening episode; it
is not a delayed screening assessment follow-up. Women
placed on short term recall should be invited to the assessment
clinic for bilateral two view mammography and may be given
their result immediately. They should not be given a routine
mammography screening appointment.
Section 251 of the
NHS Act (2006)
Short term recall
Upper Tier Local
Authority
UTLA
Short term recall must not be considered a routine outcome of
assessment. The use of triple assessment makes it possible to
reach a definitive conclusion in the great majority of cases. For
a small number of patients, however, assessment may not yield
a definitive decision and the MDT may consider surgical biopsy
inappropriate. In these few cases, short term follow-up is
required. A woman should be placed on short term recall only if
there is clear justification and after the decision has been
discussed in detail at the multidisciplinary meeting, agreed and
documented. This option should not be used as an alternative to
proper assessment.
The structure of local government varies from area to area in
England. In some areas there are two layers or tiers:
Upper tier local authorities comprise:
1.
2.
3.
4.
Unitary authorities
Non-metropolitan counties(excluding any part
specifically designated as a unitary authority such
as Southampton Leicester, etc)
The individual districts of the 6 metropolitan
counties(i.e. Tyne and Wear, West Yorkshire, South
Yorkshire, Greater Manchester, Merseyside, West
Midlands)
London Boroughs
District, Borough or City Council referred to as the lower
tier.
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Contents
1
Overview ............................................................................................................7
1.1
Supporting Documents .................................................................................. 7
1.2
Related Standards ......................................................................................... 7
1.3
Summary ....................................................................................................... 8
1.4
Purpose & Scope .......................................................................................... 9
1.5
Breast Screening Pathway Diagram ............................................................ 10
1.6
KC63 Data Flow Diagram ............................................................................ 11
1.7
KC63 Process Description........................................................................... 12
1.8
HSCIC Annual Statistical Report ................................................................. 13
1.8.1 Age ranges……………………………………………………………………14
1.9
KC62 Data Flow Diagram………………………………………………………. 14
1.10 KC62 Process Description ........................................................................... 15
1.11 HSCIC Annual Statistical Report ................................................................. 17
2
3
Health and Care Organisations ......................................................................18
2.1
Requirements .............................................................................................. 18
2.2
Conformance Criteria .................................................................................. 18
IT Systems Suppliers ......................................................................................20
3.1
Requirements .............................................................................................. 20
3.2
Conformance Criteria .................................................................................. 20
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1 Overview
1.1 Supporting Documents
Ref # Reference
Title
1
Breast Screening Programme
Dataset (KC63 and KC62)
Change Request Version 1.0
Breast Screening Programme Dataset (KC63 and KC62)
Change Request
2
Dataset (KC63 and KC62)
Implementation Guide Version 1.0
Implementation Guide
3
Dataset (KC63 and KC62) NHS
Data Model and Dictionary
Change Request
NHS Data Model and Dictionary Change Request 1348
1.2 Related Standards
Ref # Reference
Title
2
ISB 1521
Cancer Outcomes and Services Dataset Version 1.1
3
ISB 0147
Cancer Waiting Times Monitoring Dataset
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1.3 Summary
Standard
Standard Number
ISB 1597
Standard Title
Description
The KC63 and the KC62 are national statistical mandatory returns
that all breast screening units in England are required to undertake
on an annual basis. These statistical returns collate data pertaining
to core activity and outcomes from all local breast screening
programmes. The KC63 summarises call and recall activity
(coverage) and is now generated from the population database by
Upper Tier Local Authorities (UTLA) having been previously
generated by PCOs up until March 2013. The KC62 describes the
activity for a defined cohort of women.
Data from the KC63 and the KC62 returns is used for a multitude of
purposes such as:
The Breast Screening Programme Statistical Bulletin
produced annually by the HSCIC, for the purpose of reporting
activity.
The NHS Breast Screening Programme (NHSBSP) Annual
Review includes selected statistics on activity and outcomes
for the breast screening programmes across the UK.
Monitoring of national standards to evaluate the quality of the
NHSBSP.
Quality Assurance Reference Centres (QARCs) produce
reports to enable the evaluation of the quality of the breast
screening process at a regional level.
Applies to
The NHAIS System (The KC63)
The National Breast Screening System (NBSS) – The KC62
All Breast Screening Units in England – These Units are
usually within Trusts but can be run by an Independent
Organisation
UTLAs
Release
Release Number
Amd 35/2012
Release Title
2013 Change
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Description
The KC63 and the KC62 national statistical returns have been
revised to take into account recent changes in policy that have been
implemented within the NHSBSP. These policy changes relate to the
extension of the screening age range from 50-70 years to the new
screening age range of 47-73 years and the screening of women
who are at high risk, according to a set of imaging protocols agreed
by the Advisory Committee on Breast Cancer Screening in January
2012.
The KC63:
Coverage is currently measured for ages 53-70 years
because first invitation for screening could be up to 53rd
birthday. Coverage for women who are in the age extension
trial is taken from their first screening attendance. Following
completion of the age extension trial this will be changed to
measure coverage at age 50 years and 50-73 years. The
definition of coverage may need to be reviewed if full
expansion to the age range, 47-73 years, is implemented.
The numbers of high risk women who have been screened in
the period of the return being run is included
The KC62:
Introduction of the KC62 Annex which provides information
on each cancer detected allowing epidemiological
comparisons to be made.
Introduction of a separate high risk table to show the
numbers in each of the risk categories covered by the
screening programme.
Increase in screening age range from the current 50-70 years
to the new 47-73 year screening age range.
Implementation
Completion Date
01/10/2013
1.4 Purpose & Scope:
This document is a specification to achieve the standard required. Below is a flow diagram
illustrating the breast screening pathway of women who are invited for breast screening
through the NHSBSP and the various processes involved. These areas are captured within
the KC63 and the KC62 returns. The subsequent data flow diagrams and process
descriptions for the KC63 and the KC62 provide a detailed illustration and a step by step
description of the data flow pathway for the KC63 and the KC62 returns respectively. It is
imperative that this specification document is read in conjunction with the Breast Screening
Programme Data Output Specification document.
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1.5 Breast Screening Pathway Diagram
Screening round
plan
Preparation of
the screening
batch list
Recalled in
3 years
Woman invited
Declines
screening
invitation
Does not
attend
(DNA)
Attends
nd
DNA (2
appointment
letter
SCREENING
Screening
mammograms
processed
Previous
mammograms
available
Screening
mammograms
reported
Technical
recall
Normal
Normal
Abnormal
Assessment
Abnormal
Issue of
result letter
Normal but symptoms
warrant clinical recall
MDT
Normal
Diagnosis /
treatment
Outcome communicated to
woman & GP
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1.6 KC63 Data Flow Diagram
NBSS SYSTEMS
80 Locally Validated
KC63 Returns
SCREENING BATCH SPECS
SCREENING
BATCH LISTS
SCREENING BATCH
RESULTS
NHAIS SYSTEM
8 QARCS
Local KC63
Data
8 Regional
Submissions
HSCIC SSD
Regionally
Aggregated KC63
Data
Nationally Aggregated KC63 Data
HSCIC
INFORMATION
SERVICES
ANNUAL
REPORT
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1.7 KC63 Process Description
During the year, NBSS creates screening batch specifications (on paper) for the target
population
For each screening batch specification, NHAIS creates a screening batch and sends the
screening batch list (electronically) to NBSS.
NBSS invites the eligible women in each batch
Women may also be screened as a Self/GP referral, Early Recall or due to Higher Risk
(HR)
NBSS sends the invitation details and screening results (electronically) to NHAIS
Each October, NHAIS produces a local KC63 dataset for each Upper Tier Local
Authority (UTLA)
- A UTLA population may be spread across several NHAIS instances
- The KC63 target population is the eligible women registered on NHAIS on the
last day of the review period (31 March)
- The KC63 dataset is calculated 6 months in arrears, to allow time for all
screening activities started in the review period to be completed
- The KC63 counts the women who were invited as a result of being selected into a
batch in the previous 12/36 months review period
- The KC63 counts the women who were screened as a result of being selected
into a batch in the previous 12/36 months review period
- Women screened as an Early Recall during the review period are included in the
call/recall invitation and screening counts
- The KC63 counts the women who were screened as a Self or GP referral in the
previous 12/36 months review period
- The KC63 counts the women who have never been screened
- The KC63 counts the women with an overdue Open episode
- The KC63 counts the HR women invited/screened in the previous 12 months
review period
First, NHAIS creates a trial-run local KC63 dataset (on paper or as a download file) to
send to the regional QARC for review
Changes can be made on NHAIS (e.g. close to Open episodes) based on feedback from
QARC
NHAIS then creates a final local KC63 dataset which is sent to the HSCIC Systems &
Service Delivery (SSD) team electronically
HSCIC SSD aggregates the local KC63 datasets from each NHAIS system by UTLA to
create a national dataset. SSD may need to raise queries with local NHAIS teams to
resolve anomalies in the data
HSCIC SSD submits the national KC63 dataset (electronically) to the HSCIC Information
Services team
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1.8 HSCIC Annual Statistical Report (Breast Screening Programme,
England)
This report is published on an annual basis presenting information about the NHS Breast
Screening Programme in England and includes data on those invited for breast screening,
coverage, uptake of invitations, outcomes of screening and cancers detected. The statistics
are derived from information that is routinely collected via the KC63 Breast Screening Return
for the operation of the screening programme, including for quality assurance and
performance management purposes.
Data have been collected annually since 1994-95 via the KC63. The data from this return are
collected in aggregate form each year by the HSCIC. The KC63 data comes to the HSCIC
Screening Team (formerly the NHS Connecting for Health Screening team, which ceased to
exist as of March 31st 2013), which collects it from the NHAIS (Exeter) system and produces
aggregate UTLA level reports at the end of each financial year.
The table below is an illustration of the type of information that is published annually by the
HSCIC from the KC63 Breast Screening National Return. The changes to age ranges will be
reflected in future reports.
Breast screening coverage at 31st March among women aged 53-70 and 65-70,
England 2002-20121.1.8
1.8.1 Age Ranges
The irregular age bands enable time series comparison of screening programmes
before and after policy changes have been implemented.
Women are invited for their first screen between 50 and 53, this is because breast
screening is organised in 3 year cycles.
At any time it is expected that around 50% of 50-52 year olds will have been invited
in the previous 3 years compared to nearly 100% of 53-54 year olds. Therefore the 5
year age band is split to enable separate analysis of these two groups.
Women being screened for the first time (prevalent round) and women being
screened subsequently (incident round) are analysed separately. This is because,
statistically, there are a greater number of cancers detected in the prevalent round
than the incident round.
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1.9 KC62 Data Flow Diagram
Mammography screening
Outcomes
NBSS SYSTEMS
80 Locally Validated
KC62 Returns
SCREENING BATCH SPECS
SCREENING
BATCH
LISTS
SCREENING BATCH
RESULTS
NHAIS SYSTEM
8 QARCS
Local KC62
Data
8 Regional
Submissions
HSCIC SSD
Regionally
Aggregated KC62
Data
Nationally Aggregated KC62 Data
HSCIC
INFORMATION
SERVICES
ANNUAL
REPORT
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1.10 KC62 Process Description
During the year, NBSS creates screening batch specifications (on paper) for the target
population from the screening round plan
For each screening batch specification, NHAIS creates a screening batch and sends the
screening batch list (electronically) to NBSS.
NBSS invites the eligible women in each batch
Women may also be screened as a Self/GP referral, Early Recall or due to Higher Risk
(HR)
NBSS sends the invitation details and screening results (electronically) to NHAIS
Each October, NBSS produces a KC62 that includes all women with a date of first
offered screening appointment between 1st April of the previous year and 31 March of
the same year
The KC62 is divided into tables, each table being a subset of the total number of women
invited as follows:
A - 1st invitation for routine screening
B - Routine invitation for previous non-attenders
C1 - Routine invitation for previous attenders. Last screen within 5 years
C2 - Routine invitation for previous attenders. Last screen more than 5 years
previously
D - Short Term recalls
E - Self/GP referrals of women not screened previously
F1- Self/GP referrals of women screened previously. Last screen within 5 years
F2 - Self/GP referrals of women screened previously. Last screen more than 5 years
previously
T - All invitations and screenings. Sum of A-F2
U - High Risk Screening Programme (which includes an annex for individual level
information
The KC62 produces an annex which lists basic pathology data for each screen detected
cancer
The KC62 tables are compiled 6 months in arrears to allow for all screening and any
subsequent diagnostic and treatment data to be entered onto NBSS
The KC62 counts the number of women invited, screened, assessed and diagnosed with
breast cancer during the year
The KC62 records the method of diagnosis of breast cancer, counting the number of
women diagnosed non-operatively (by core biopsy/FNA) and those diagnosed by open
surgical biopsy
The KC62 counts the number of women returned to routine recall and put onto short
term recall following core biopsy/FNA or open surgical biopsy
The KC62 counts the number of women having a benign open surgical biopsy
The KC62 counts the type and size of cancers detected
The KC62 reports the completeness of the data entered on NBSS
The KC62 reports outcome measures
The KC62 counts the number of women entered into the high risk screening programme
with the risk factor and screening protocol
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The Screening Service sends the completed KC62 (download file and paper copies) to
the regional QARC for review
Changes can be made on NBSS (e.g. to complete unknown information/amend errors)
based on feedback from QARC
KC62 final version submitted to QARC who then compile outcome measures and
performance statistics for the Service to be used in QA visits and service monitoring
QARC submit KC62s from all the Services they monitor (a region) to the HSCIC
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1.11 HSCIC Annual Statistical Report (Breast Screening Programme,
England)
This report is published on an annual basis presenting information about the NHS Breast
Screening Programme in England and includes data on those invited for breast screening,
coverage, uptake of invitations, outcomes of screening and cancers detected. The statistics
are derived from information that is routinely collected via the KC62 Breast Screening
Returns for the operation of the screening programme, including for quality assurance and
performance management purposes.
Data have been collected annually since 1988-89 via the KC62. The data from this return are
collected in aggregate form each year by the HSCIC. The KC62 data comes to the HSCIC
via the NHS Breast Screening Programme regional Quality Assurance Reference Centres
(QARCs), which collect it from all breast screening units in their region at the end of each
financial year.
The chart below is an illustration of the type of information that is published annually by the
HSCIC from the KC62 Breast Screening National Returns. Changes to age ranges will be
reflected in future publications from HSCIC.
Women with cancer detected (rate per 1,000 women screened) by age group and type
of invitation, in England, 2011-12
Rate per 1,000 women screened
Type of invitation / referral
45 and
over
50 - 70
45 - 49
50 - 54
55 - 59
60 - 64
65 - 70
Over
70
Total
8.1
7.9
6.7
6.6
6.3
8.6
10.4
13.9
7.8
8.3
6.7
7.8
10.8
15.3
15.8
(22.4)
1 invitation for routine
screening
7.3
7.7
6.7
7.6
9.7
7.6
(9.7)
(16.7)
Routine invitation to
previous non-attenders
11.7
11.6
(7.5)
9.6
11.0
18.8
19.4
(24.5)
previous attenders (Last
screen within 5 years)
7.6
7.5
(5.7)
5.0
5.9
8.2
9.9
10.9
previous attenders (Last
screen more than 5 years
previously)
11.5
11.2
(11.9)
4.5
7.8
11.0
15.6
17.2
Early recalls
(31.0)
(25.3)
(32.3)
(10.8)
(30.7)
(46.4)
(35.5)
(102.6)
Self / GP referral (no
previous screen)
12.2
10.9
(9.6)
9.6
12.6
(16.7)
(11.3)
(27.2)
Self / GP referral (within 5
years)
11.9
10.2
-
8.6
7.8
10.1
13.4
12.6
Self / GP referral (> 5 years)
21.8
13.3
-
-
(8.6)
(14.1)
(16.6)
25.0
Prevalent Screens
(a)
st
Incident Screens
(b)
(a)
Prevalent relates to first invitations for routine screening and routine invitations to previous non-attendees.
Incident refers only to routine invitations to previous attendees last screened within 5 years.
Rates shown in brackets are based on fewer than 2000 women screened. - = Zero.
Source: KC62 (Part 1 and 3, Tables A to F2) Health and Social Care Information Centre
(b)
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2 Health and Care Organisations
2.1 Requirements
This specification relates to the Breast Screening Programme Dataset (KC63 and KC62)
Data Output Specification. The dataset applies to all PCOs, BSUs and QARCs as specified
in the dataset and guidance documents.
1
#
Requirement
1
BSUs MUST have implemented this revised return by the end of September 2013 ready for the
official run in October 2013.
2
BSUs MUST carry out data quality checks for data completeness and data quality, in advance
of the official run.
3
BSUs MUST extract data annually for checking and validation but MAY wish to carry out
monthly to assist with the annual return.
4
BSUs MAY wish to analyse the csv file to check for data inconsistencies.
5
BSUs MUST run the KC62 annually and submit this data to their QARC.
6
BSU Directors MUST sign off KC62 as complete and validated
7
PCOs MUST run the KC63 annually.
8
QARCs MUST validate the KC62 and the KC63 before submission to the HSCIC.
9
The HSCIC MUST use the data in the revised returns for annual reporting of breast screening
outcomes.
10
QARCs MAY use the revised returns to enable evaluation of the quality of the breast screening
outcomes at a local and regional level.
11
The PRU MAY use the data in the revised returns for monitoring and evaluation purposes.
2.2 Conformance Criteria
This section describes the tests that can indicate that the standard is being used correctly by
an organisation (conformance criteria). These may be different depending upon the type of
organisation, e.g. supplier, Trust, PCO. These conformance criteria are provided on the
understanding that we do not have direct control of the whole system and we cannot force
individual users to conform. The key is that:
The standard is implemented correctly in the relevant systems
That guidance is provided (along with training) and that it is followed
That data quality issues are fed back to individual organisations / systems suppliers in
a timely fashion and that these messages are acted upon;
That best practice is shared within and between organisations regarding processes
for data capture / update;
That the standards are reviewed with systems suppliers (e.g. NBSS / NHAIS) and
users / stakeholders
All MUST requirements must be met.
1
The key words MUST, SHOULD and MAY are defined in the information standards development
methodology. They follow RFC-2119.
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All SHOULD requirements must be met or a credible reason documented for why
they have not been (i.e. they don’t apply to the scope of the system).
MAY requirements are optional.
The following specific conformance criteria will be used to demonstrate conformance.
#
Conformance criteria
1
The Implementation Guidance SHOULD be reviewed in conjunction with the data set output
specification by users in order to understand the scope and requirements of the data set and
engage with appropriate IT and training resources
2
BSUs, PCOs and QARCs MUST follow the implementation guidance for KC63 and KC62
3
BSUs and PCOs SHOULD be able to extract information to meet the data output requirements
defined by the data set output specification in order to create the annual data submission files.
4
BSUs and PCOs MUST ensure data for submission is formatted according to NHS Data
Dictionary specifications
BSUs and PCOs MUST submit data items as specified in the Implementation Guidance to
QARCs within the defined time period and in the format specified in these documents.
5
6
QARCs MUST send any queries to BSUs in a timely manner to ensure that finalised data
submission files can be sent to HSCIC within the required time period
7
BSUs MUST action and address queries raised by the QARCs.
8
The HSCIC must publish an annual report of the data submitted by QARC within the defined
time period
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3 IT Systems Suppliers
3.1 Requirements
This specification relates to the Breast Screening Programme Dataset (KC63 and KC62)
Data Output Specification. The dataset applies to all PCOs, BSUs and QARCs as specified
in the dataset and guidance documents.
#
Requirement
1
The IT system suppliers MUST develop, test and implement the revised returns.
2
The IT system suppliers MUST implement changes in accordance with the contractual
arrangements to enable all specified data items in the KC63 and the KC62 to be captured and
extracted in compliance with the Specification and Implementation Guidance
3
The IT system suppliers MUST provide comprehensive release notes to users before the
official run of the revised return.
4
The IT system suppliers MUST provide comprehensive updated user guidance notes to users
before the official run of the revised return.
6
The IT SYSTEM suppliers MUST provide regular updates to the NBSS Programme Board.
7
All testing SHOULD be undertaken with the active involvement of end users.
8
The release notes and user guidance SHOULD include the feedback received from the end
users that were involved in the testing phase of the project.
9
The IT system suppliers SHOULD log issues and risks.
3.2 Conformance Criteria
This section describes the tests that can indicate that the standard is being used correctly by
an organisation (conformance criteria). These may be different depending upon the type of
organisation, e.g. supplier, Trust, PCO. These conformance criteria are provided on the
understanding that we do not have direct control of the whole system and we cannot force
individual users to conform. The key is that:
The standard is implemented correctly in the relevant systems
That guidance is provided (along with training) and that it is followed;
That data quality issues are fed back to individual organisations / systems suppliers in
a timely fashion and that these messages are acted upon;
That best practice is shared within and between organisations regarding processes
for data capture / update;
That the standards are reviewed with systems suppliers (e.g. NBSS / NHAIS
comparison exercise intended to remove any issues which have developed) and
users / stakeholders
All MUST requirements must be met.
All SHOULD requirements must be met or a credible reason documented for why
they have not been (i.e. they don’t apply to the scope of the system).
MAY requirements are optional.
The following specific conformance criteria will be used to demonstrate conformance.
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#
Conformance criteria
1
The IT system suppliers MUST provide regular test reports demonstrating that the revised
return meets the agreed specification.
2
End users SHOULD be actively involved in the testing of the revised returns
3
Staff using the KC63 and KC62 standards in the respective IT systems SHOULD report no
concerns related to its use.
4
The IT system suppliers MUST provide a comprehensive update report to the NBSS
Programme Board on a six-monthly basis.
5
Users SHOULD receive the comprehensive release notes and updated user guidance
documentation prior to the official run of the revised return
6
All logged issues and risks MUST be reviewed by the IT system suppliers
7
Appropriate action MUST be taken by the IT system suppliers to mitigate any identified risks
and / or issues.
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Document 6423831

Transcription

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