Breast Screening Programme Policy 1.1 24 Jun 13 Breast Screening Programme Policy Page 1 of 15 Table of Contents 1. Introduction ................................................................................................................... 3 2. Purpose of this Policy ................................................................................................... 3 3. Scope ........................................................................................................................... 3 4. Definitions / Glossary .................................................................................................... 3 5. Ownership and Responsibilities .................................................................................... 4 5.2. Duties within the organisation ................................................................................ 5 5.3. Duties external to the Organisation ....................................................................... 5 6. Standards and Practice ................................................................................................ 6 6.2. Duties .................................................................................................................... 6 6.3. Process for Requesting Screening Procedures identifying and calling women/consent ................................................................................................................ 7 6.4. Process for the Receipt of the Results of a Screening Test .................................. 7 6.6. Process for Taking Action on Screening Results ................................................... 8 6.7. Process for Documentation of Screening Results ................................................. 9 6.8. Process for the Communication of Screening Results........................................... 9 7. Dissemination and Implementation ............................................................................... 9 8. Monitoring compliance and effectiveness ..................................................................... 9 9. Updating and Review.................................................................................................. 10 10. Equality and Diversity.............................................................................................. 10 10.2. Equality Impact Assessment ............................................................................ 10 Appendix 1. Governance Information ................................................................................ 11 Appendix 2.Initial Equality Impact Assessment Screening Form ....................................... 13 Appendix 3. Screening Round Plan Flow Chart ................................................................. 15 Breast Screening Programme Policy Page 2 of 15 1. Introduction 1.1. The NHSBSP began in 1988.At present it aims to invite all women aged 5070 years for mammographic screening once every three years. The programme now screens 1.3 million women each year of which about 75% attend, and the programme diagnoses about 10,000 breast cancers annually (NHSBSP publication no.61) 1.2. This document has been produced to support the National Breast Screening Standard Operating Procedures which can be found on the National Health Service National Breast Screening Programme (NHSBSP) website in numerous publications and within the Cornwall Breast Screening Centre in the Quality Management System 1.3. Cornwall Breast Screening invites around 65,000 women over the course of three years for mammographic screening. Around 7% of these ladies are recalled for assessment and approximately 140 cancers are diagnosed annually. The programme adheres to the national guidelines set out by the NHSBSP in publication no.60. 2. Purpose of this Policy 2.1. Breast Screening is a process of identifying well women between the ages of 50 and 70 who may be at increased risk of/in the early stages of Breast Cancer. They can then be offered information, further tests and appropriate treatment. 2.2. The purpose of this document is to ensure that all risks associated with the RCHT Breast Screening programme are managed and compliant with NHSLA standards. 2.3. All procedures before, during and after Breast Screening are stored in an electronic shared folder and a paper master copy, (Quality Management System QMS) situated in the Radiographer Team Lead office. 3. Scope This policy applies to all those involved in Breast Screening procedures and Quality Assurance in the organisation. 4. Definitions / Glossary NSC National Screening Committee The UK National Screening Committee (UK NSC) is chaired by the Chief Medical Officer for Scotland, advises Ministers and the NHS in the four UK countries about all aspects of screening and supports implementation of screening programmes. Using research evidence, pilot programmes and economic evaluation, it assesses the evidence for programmes against a set of internationally recognised criteria covering the condition, the test, the treatment options and the effectiveness and acceptability of the screening programme. Assessing programmes in this way is intended to ensure that they do Breast Screening Programme Policy Page 3 of 15 more good than harm at a reasonable cost. The UK NSC also sets up practical mechanisms to oversee the introduction of new programmes in the English NHS and monitors effectiveness and quality of these programmes. Screening Screening is a process of identifying apparently healthy people who may be at increased risk of a disease or condition QMS Quality Management Systems A clear, step-by-step working instruction of how to carry out agreed actions that promote uniformity to help clarify and augment processes. QMS documents the way activities are to be performed to facilitate consistent conformance to requirements and to support data quality. QMS provides individuals with the information needed to perform a job properly and consistently. SOP Standard Operating Procedures Document the way activities are to be performed to facilitate consistent conformance to requirements and to support data quality. SOPs provide individuals with the information needed to perform a job properly and consistently. WI Working Instructions This indicates the reference number where the protocol for the procedures followed can be found in the QMS file QA Quality Assurance Quality assurance (QA) has been an integral part of the NHSBSP since it was introduced in 1988. This is to ensure that all women have access to a high quality breast screening service, wherever they live in the UK. QARC Quality Assurance Reference Centres There are minimum QA standards that all of the disciplines in the NHSBSPs have to meet and maintain. These standards are monitored by regional Quality Assurance Reference Centres (QARCs), which also act to promote the sharing of good practice between BSPs. There are eight regional QARCs which cover the whole of England, with Scotland, Wales and Northern Ireland each having their own QARCs. Each QARC is headed by a Director of QA who heads a team typically comprising of a QA Co-ordinator, Professional QA Coordinators for each of the breast screening disciplines, Audit staff and Administration staff. The Director of QA is directly accountable to the Regional Director of Public Health 5. Ownership and Responsibilities 5.1. This section gives a detailed overview of the strategic and operational roles responsible for the development, management and implementation of the policy. Breast Screening Programme Policy Page 4 of 15 5.2. Duties within the organisation The duties of the directors, committees, clinicians, healthcare and administrative staff with responsibility for managing the processes surrounding screening procedures are outlined below: Chief Executive - The Chief Executive has ultimate responsibility for ensuring that suitable structures, resources and monitoring arrangements are in place to ensure that screening procedures are carried out in a safe and effective way. Trust Boards - The Trust Board must seek assurance that screening procedures are carried out in a safe and effective way. Divisional Quality Group - The Divisional Quality Group (DQG) will receive a quarterly summary of all adverse incident reports related to screening procedures and analyse the annual audit tool kit returns. This group is responsible for the overview of screening procedures within the Trust and adherence to organisational and local standards. Director of Breast Screening is responsible for the management and performance of the Breast Screening programme (NHSBSP Publication No 52) Breast Screening Supervisor – Programme Administrator and Superintendent Radiographers The Breast Screening Lead will liaise with screening staff and the National Breast Screening Office to produce the annual required results and audits, Lead Clinician/Director - The Trust’s Medical Director plays a lead role in the development of organisation-wide and local procedural documents to manage the risks associated with screening procedures. This includes ensuring that all tests and procedures are undertaken by authorised staff following training where necessary; developing standing operating procedures or equivalent protocols to an agreed organisational or national standard. Screening Staff - The screening pathway begins when an individual is identified as meeting the criteria to be offered the opportunity of Breast screening. Should the offer of screening be taken up, the relevant protocol will be followed. Accurate records will be kept in the event that screening is declined. Various healthcare staff may be involved in this pathway including Doctors, Nurses, Healthcare Assistants/Support workers and Professions Allied to Medicine. Responsibilities include adherence to standard operating procedures or equivalent protocols; undertaking training as required and agreed. Administrative Staff - Administrative staff have an important role in ensuring that, for paper based and electronic systems, all records are kept up to date and that administrative protocols are followed. 5.3. Duties external to the Organisation External bodies have a role in providing external quality assurance and protocol guidance and where relevant programme management of the screening service provided. Such bodies include: Breast Screening Programme Policy Page 5 of 15 National Screening Committee/NHS Screening Programme Committees External Quality Assessment/Assurance schemes (Regional and National) Synertec PCT QARC 6. Standards and Practice 6.1. Standards for Breast Screening comply with the National Health Service Breast Screening Programme (NHSBSP) guidelines and procedures and are set out in the numerous relevant NHSBSP Publications, All screening procedures are undertaken by authorised healthcare staff that have been trained and accredited by approved Breast Screening Courses 6.2. Duties The undertaking and outcome of Breast Screening will be documented on the dedicated National Breast Screening Computer System (NBSS) The result, the interpretation and the subsequent surveillance plan will be managed by Breast Clinicians, Breast Radiologists, Consultant Radiographers, Advanced Radiographers. Routine Recall results are communicated to the women by letter within a three week target deadline and their GP will be informed by a bulk report produced by the local breast screening office. the continuous performance management and monitoring of the screening procedures is provided by a three yearly QA visit and National Audit of results Line managers are responsible for ensuring that staff follow those processes and procedures described in the Standards and Practice (QMS) relevant to the part they play in the screening procedure; The Trust Screening Lead is responsible for the development, approval, communication of this policy and monitoring compliance with it by use of the Annual Audit Tool. All staff members are responsible for being aware of the policy and any documents referred to within it pertaining to their part in the screening pathway; adhering to any requirements described within the policy and documents described in the standards and practice section pertaining to their role in the diagnostic pathway. Clinical Directors and the Breast Screening Centre programme administrator are responsible for completion of the annual audit tool and for screening governance which includes the reporting of any deviation or errors arising from the screening procedures using the RCHT Trust reporting system and governance processes. The continuous performance management and monitoring of the screening procedures are provided via Crystal reports to QARC generated both monthly and quarterly, KC62 which is an annual report and three yearly QA inspection. Breast Screening Programme Policy Page 6 of 15 6.3. Process for Requesting Screening Procedures and calling women/consent identifying The Screening office requests all eligible women’s details from the Primary Care Support Agency by GP practice. All GPs are informed 8 weeks in advance of ladies from their practice being screened. GPs are advised to update ladies details and to provide the details of any ladies not to be called for screening (deceased, bi-lateral mastectomy) to the screening office. Valid consent must be given prior to a screening test being undertaken, in line with RCHT Consent Policy or, if the patient does not have the mental capacity to decide whether to have the test, a best interest’s decision should be made on their behalf, as described in The Mental Capacity Act 2005. Women over the age for routine call for screening may self refer see QMS WI 3.7. 6.4. Process for the Receipt of the Results of a Screening Test 6.5. The process for the recording and dissemination of the results adheres to local protocols (QMS) in line with NHSBSP Publication No 55 Right Results Audit and includes the following: the process for recording of the result; o QMS WI 6.1 Preparation of Screening Clinics for Film reading 6.2 Film Reading 8.2 Updating Arbitration 6.4. Partial mammography the interpretation of the result; o QMS WI 6.2 Film Reading 7.2 Admin for Technical recalls 7.3 TR booking Procedure 8.1 Routine Results 8.2 Updating Arbitration 9.1 Recalls To Assessment Breast Screening Programme Policy Page 7 of 15 9.2 Booking assessments that the management plan is recorded in the designated media; o QMS WI 6.1Preparation of Clinics for Bulk Updating 8.1 Routine results 9.1Recalls to Assessment 7.2 Admin for Technical Recalls DNA letter ‘fail safe’ measures to ensure that results are not inadvertently missed. Regular audits o QMS WI 10.6 Regular audits (daily)/weekly/monthly) 10.4 Missing results report (weekly) 3.5 Synertec Audits for results letters(definition of codes) Form 1- Breast screening tracking form 6.6. Process for Taking Action on Screening Results that identified actions are documented; o QMS WI 7.3 Technical Recall booking procedure 8.1 Routine results 9.2 Booking assessments Initial screening results are communicated by letter, assessment results are given face to face with a follow up letter. Routine results are communicated within 3 weeks this is checked on a monthly basis reports are run from Crystal monitoring QARC run checks every month from our computers to audit the process Missed or incorrect diagnosis must be reported using the Trust incident reporting system. Missed or incorrect diagnosis is also reviewed by QARC. Technical repeat audits are run monthly locally and by QARC.( folder of results in Team Lead Office) Breast Screening Programme Policy Page 8 of 15 6.7. Process for Documentation of Screening Results audits are performed monthly o WI 106 all screening results are recorded on the NHSBSP computer system 6.8. Process for the Communication of Screening Results Initial screening results are communicated by letter, assessment results are given face to face with a follow up letter. o Results will then be confirmed in writing to the womens’ home address and GP o Reports to GP o WI 8.4 7. Dissemination and Implementation The document will be placed on the Cornwall & Isles of Scilly Health Community Documents Library. It will also appear on Screening Testing A-Z of Services Intranet pages as well as a link on the individual screening programme intranet pages. A global email will be sent to all Service Users. 8. Monitoring compliance and effectiveness Element to be monitored Lead Tool Frequency Reporting arrangements Target/breaches Audit repeats Acting on recommendations and Lead(s) Change in practice and lessons to be shared Routine Results sent within 2 weeks >90% Date of first offered assessment appointment to be within 3 weeks >90% Date of first attended assessment appointment to be within 3 weeks >90% Technical repeat and recall rate to be <3% Dr Donna Christensen Director of Cornwall Breast Screening Crystal Reports KC62 Audit / Performance Monitoring Monthly/Annually / Quarterly The Trust Screening Lead will circulate and collect the Annual Audit Tool for submission to the Divisional Quality Group for analysis. Monthly/Quarterly Performance Monitoring will be prepared and presented to QARC/Trust The Division which encompasses the service provided will undertake subsequent recommendations and action planning for any or all deficiencies and recommendations within reasonable timeframes. Required changes to practice will be identified and actioned within three months (where reasonable). A lead member of the team will be identified to take each change forward where appropriate. Lessons will be shared with all relevant stakeholders. Breast Screening Programme Policy Page 9 of 15 9. Updating and Review 9.1. This policy will be reviewed every two years or sooner if circumstances suggest this may be necessary. 9.2. Where the revisions are significant and the overall policy is changed, the author will ensure the revised document is taken through the standard consultation, approval and dissemination processes. 9.3. Where the revisions are minor, e.g. amended job titles or changes in the organizational structure, approval can be sought from the Executive Director responsible for signatory approval, and can be re-published accordingly without having gone through the full consultation and ratification process. 9.4. Any Revision activity will be recorded in the Version Control Table as part of the document control process. 10. Equality and Diversity 10.1. This document complies with the Royal Cornwall Hospitals NHS Trust service Equality and Diversity statement. 10.2. Equality Impact Assessment 10.3. The Initial Equality Impact Assessment Screening Form is at Appendix 1. Breast Screening Programme Policy Page 10 of 15 Appendix 1. Governance Information Document Title Breast Screening Programme Policy Date Issued/Approved: 24 Jun 13 Date Valid From: 24 Jun 13 Date Valid To: 24 Jun 16 Directorate / Department responsible (author/owner): Breast Screening Programme Administrator/Lead Radiographers Catherine.rule@rcht.cornwall.nhs.uk or Diana.williams@rcht.cornwall.nhs.uk This organisation-wide policy for the Management of Breast Screening outlines the documented process for managing the risks associated with screening procedures and that those risks are managed through locally approved policies that are implemented and monitored. Contact details: Brief summary of contents Suggested Keywords: RCHT Target Audience PCT CFT Executive Director responsible for Policy: Chief Operating Officer Date revised: 24 Jun 13 This document replaces (exact title of previous version): Breast Screening Programme Policy Approval route (names of committees)/consultation: Diagnostics Lead Divisional Manager confirming approval processes Emma Spouse Diagnostics Lead Name and Post Title of additional signatories Not Required Signature of Executive Director giving approval Publication Location (refer to Policy on Policies – Approvals and Ratification): {Original Copy Signed} Internet & Intranet Intranet Only Document Library Folder/Sub Folder Clinical/Breast Links to key external standards NHSLA Standards National Breast Screening Programme Breast Screening Programme Policy Page 11 of 15 Standards Related Documents: The 2011 NHSLA Risk Management Standards Handbook NHSLA Standards 2011-2012 NHSBSP Publication No. 60 Training Need Identified? No Version Control Table Date Version No Summary of Changes May 12 V1.0 Initial Issue Jun 13 V1.1 Correct para numbering Changes Made by (Name and Job Title) Diana Williams, Senior Radiographer Diana Williams, Senior Radiographer All or part of this document can be released under the Freedom of Information Act 2000 This document is to be retained for 10 years from the date of expiry. This document is only valid on the day of printing Controlled Document This document has been created following the Royal Cornwall Hospitals NHS Trust Policy on Document Production. It should not be altered in any way without the express permission of the author or their Line Manager. Breast Screening Programme Policy Page 12 of 15 Appendix 2.Initial Equality Impact Assessment Screening Form Name of service, strategy, policy or project (hereafter referred to as policy) to be assessed: Breast Screening Procedure Policy Directorate and service area: Human Is this a new or existing Procedure? New Resources Name of individual completing Telephone: 2884 assessment: Catherine Rule 1. Procedure Aim* Sets out an approved documented process whereby the risks associated with Breast screening procedures are managed through the provision of local policies which are implemented and monitored. 2. Procedure The risks associated with Breast screening procedures Objectives* are minimised; compliance with NHSLA Standard 4 – Criterion 3: Screening Procedures is achieved. 3. Procedure – intended To ensure that the Breast screening procedures provided by Outcomes* the organisation have developed, documented local processes and that screening is offered as appropriate, records are accurate and risks are minimised. 4. How will you As described in section 8 measure the outcome? 5. Who is intended to All individuals being screened benefit from the Procedure? 6a. Is consultation No required with the workforce, equality groups etc. around this procedure? b. If yes, have these groups been consulted? c. Please list any groups who have been consulted about this procedure. *Please see Glossary 7. The Impact Please complete the following table using ticks. You should refer to the EIA guidance notes for areas of possible impact and also the Glossary if needed. Where you think that the policy could have a positive impact on any of the equality group(s) like promoting equality and equal opportunities or improving relations within equality groups, tick the ‘Positive impact’ box. Where you think that the policy could have a negative impact on any of the equality group(s) i.e. it could disadvantage them, tick the ‘Negative impact’ box. Breast Screening Programme Policy Page 13 of 15 Where you think that the policy has no impact on any of the equality group(s) listed below i.e. it has no effect currently on equality groups, tick the ‘No impact’ box. Equality Group Age Positive Impact Disability Religion or Belief Gender Transgender Negative Impact No Reasons for decision Impact Breast Screening is targeted at women from 50 to 70 years as research screening of women in the 40-50 age group is less effective. Women over the age of 70 can self refer for a mammogram with their Local Breast Screening service Breast Screening is aimed at a target population and condition Breast Screening is aimed at a target population and condition. Breast Screening is targeted at women from the age of 50. Pregnancy/ Maternity Race Sexual Orientation Marriage / Civil Partnership Breast Screening is aimed at a target population and condition. Breast Screening is aimed at a target population and condition. You will need to continue to a full Equality Impact Assessment if the following have been highlighted: A negative impact and No consultation (this excludes any policies which have been identified as not requiring consultation). 8. If there is no evidence that the policy promotes equality, equal opportunities or improved relations - could it be adapted so that it does? How? Full statement of commitment to policy of equal opportunities is included in the policy Please sign and date this form. Keep one copy and send a copy to Matron, Equality, Diversity and Human Rights, c/o Royal Cornwall Hospitals NHS Trust, Human Resources Department, Chyvean House, Penventinnie Lane, Truro, Cornwall, TR1 3LJ A summary of the results will be published on the Trust’s web site. Signed ________________________________________ Date _________________________________________ Breast Screening Programme Policy Page 14 of 15 Appendix 3. Screening Round Plan Flow Chart Breast Screening Programme Policy Page 15 of 15
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