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 Breast Screening Programme Dataset (KC63 and KC62) Standard Specification 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 NHS Cancer Screening Programmes NHS Cancer Screening Programmes © Information Standards Board for Health and Social Care 2013 rd th th th rd th rd th th th rd th rd th th th rd th TH August 2013 Page 2 of 21 Breast Screening Programme Dataset (KC63 and KC62) Standard Specification 29/08/2013 <1.0> 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 © Information Standards Board for Health and Social Care 2013 Page 3 of 21 Breast Screening Programme Dataset (KC63 and KC62) Standard Specification 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 © Information Standards Board for Health and Social Care 2013 Page 4 of 21 Breast Screening Programme Dataset (KC63 and KC62) Standard Specification 29/08/2013 <1.0> 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. © Information Standards Board for Health and Social Care 2013 Page 5 of 21 Breast Screening Programme Dataset (KC63 and KC62) Standard Specification 29/08/2013 <1.0> 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 © Information Standards Board for Health and Social Care 2013 Page 6 of 21 Breast Screening Programme Dataset (KC63 and KC62) Standard Specification 29/08/2013 <1.0> 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 Breast Screening Programme Dataset (KC63 and KC62) Implementation Guide Version 1.0 Breast Screening Programme Dataset (KC63 and KC62) Implementation Guide 3 Breast Screening Programme Dataset (KC63 and KC62) NHS Data Model and Dictionary Change Request Breast Screening Programme Dataset (KC63 and KC62) 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 © Information Standards Board for Health and Social Care 2013 Page 7 of 21 Breast Screening Programme Dataset (KC63 and KC62) Standard Specification 29/08/2013 <1.0> 1.3 Summary Standard Standard Number ISB 1597 Standard Title Breast Screening Programme Dataset (KC63 and KC62) 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 © Information Standards Board for Health and Social Care 2013 Page 8 of 21 Breast Screening Programme Dataset (KC63 and KC62) Standard Specification 29/08/2013 <1.0> 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. © Information Standards Board for Health and Social Care 2013 Page 9 of 21 Breast Screening Programme Dataset (KC63 and KC62) Standard Specification 29/08/2013 <1.0> 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 © Information Standards Board for Health and Social Care 2013 Page 10 of 21 Breast Screening Programme Dataset (KC63 and KC62) Standard Specification 29/08/2013 <1.0> 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 © Information Standards Board for Health and Social Care 2013 ANNUAL REPORT Page 11 of 21 Breast Screening Programme Dataset (KC63 and KC62) Standard Specification 29/08/2013 <1.0> 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 © Information Standards Board for Health and Social Care 2013 Page 12 of 21 Breast Screening Programme Dataset (KC63 and KC62) Standard Specification 29/08/2013 <1.0> 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. © Information Standards Board for Health and Social Care 2013 Page 13 of 21 Breast Screening Programme Dataset (KC63 and KC62) Standard Specification 29/08/2013 <1.0> 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 © Information Standards Board for Health and Social Care 2013 ANNUAL REPORT Page 14 of 21 Breast Screening Programme Dataset (KC63 and KC62) Standard Specification 29/08/2013 <1.0> 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 © Information Standards Board for Health and Social Care 2013 Page 15 of 21 Breast Screening Programme Dataset (KC63 and KC62) Standard Specification 29/08/2013 <1.0> 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 © Information Standards Board for Health and Social Care 2013 Page 16 of 21 Breast Screening Programme Dataset (KC63 and KC62) Standard Specification 29/08/2013 <1.0> 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) Routine invitation to previous attenders (Last screen within 5 years) 7.6 7.5 (5.7) 5.0 5.9 8.2 9.9 10.9 Routine invitation to 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) © Information Standards Board for Health and Social Care 2013 Page 17 of 21 Breast Screening Programme Dataset (KC63 and KC62) Standard Specification 29/08/2013 <1.0> 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. © Information Standards Board for Health and Social Care 2013 Page 18 of 21 Breast Screening Programme Dataset (KC63 and KC62) Standard Specification 29/08/2013 <1.0> 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 © Information Standards Board for Health and Social Care 2013 Page 19 of 21 Breast Screening Programme Dataset (KC63 and KC62) Standard Specification 29/08/2013 <1.0> 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. © Information Standards Board for Health and Social Care 2013 Page 20 of 21 Breast Screening Programme Dataset (KC63 and KC62) Standard Specification 29/08/2013 <1.0> # 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. © Information Standards Board for Health and Social Care 2013 Page 21 of 21
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