Specialised Services Service Specification: CP57b. Genetic Testing for Inherited Cardiac Conditions
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1 Specialised Services Service Specification: CP57b Genetic Testing for Inherited Cardiac Conditions Document Author: Specialised Planner Executive Lead: Director of Finance Approved by: Management Group Issue Date: 8 th November 2012 Review Date: November 2015 Document No: CP57b Page 1 of 13
2 Document History Revision History Version No. Revision date Summary of Changes Updated to version no.: /02/2013 Additional Text added to points and and Figure 1 diagram at point 2.2 has been amended 2.0 Date of next revision Consultation Name Date of Issue Version Number Executive Team Sept Management Group 08/11/ Approvals Name Date of Issue Version No. Management Group 08/11/ Distribution this document has been distributed to Name By Date of Issue Version No. Page 2 of 13
3 Table of Contents 1. Aim Introduction Relationship with other Policy and Service Specifications Service Delivery Service Model Care Pathway Quality and Patient Safety Quality and Patient Safety Quality Indicators (Standards) Putting Things Right: Raising a Concern Performance Monitoring and Information Requirements Performance Monitoring Key Performance Indicators Equality Impact and Assessment Page 3 of 13
4 1. Aim 1.1 Introduction The document has been developed as the service specification for the planning of genetic testing for inherited cardiac conditions for patients and families resident in Wales. The purpose of this document is to: detail the specification for genetic testing for patients and families who are resident in Wales; and identify which organisations are able to provide a genetics testing service for Welsh patients. 1.2 Relationship with other Policy and Service Specifications This document should be read in conjunction with the following documents: All Wales Policy for Making Decisions on Individual Patient Funding Requests Page 4 of 13
5 2. Service Delivery se 2.1 Service Model Scope The service provides genetic testing in carefully selected families with one of the following clinical diagnoses: Hypertrophic Cardiomyopathy Long QT syndrome Catecholaminergic Polymorphic VT and, occasionally, other conditions when testing is identified as appropriate by the regional MDT provided that i) the probability of a positive result should be assessed as at least 50%, and ii) the number of index tests in this category should not exceed 10% of the total number of index tests Model of Delivery The service will be delivered through collaboration between cardiology services and the All Wales Medical Genetics Service (AWMGS). Cardiology services and the AWMGS will identify potential patients and families for genetic testing, and use the test results to inform patient management. The AWMGS will manage the process of counselling patients/families, procuring the laboratory tests (required from outside Wales), providing interpretation and advice on the results and undertaking cascade testing Identification of Families for Genetic Testing Patients suspected of having an inherited cardiac condition will be referred by their local inherited cardiac conditions service to the regional inherited cardiac conditions multi-disciplinary team (ICC MDT) for consideration of referral for genetic testing. Where the local inherited cardiac conditions service is provided by cardiology services in England, patients will be referred to a regional ICC MDT within Wales. Page 5 of 13
6 The ICC MDT will consider referrals to ascertain if the clinical diagnosis is within the scope of the cardiogenetics service and the suitability for genetic testing. In cases where the diagnosis is not one of the preselected conditions, there is discretion for the MDT to approve referral to the AWMGS where in the view of the MDT the probability of a positive result is at least 50% Gatekeeping The ICC MDTs are the gatekeepers for referrals to the AWMGS for cardiogenetic testing. All referrals to the AWMGS for cardiogenetic testing must be approved by the regional ICC MDT. Referrals that have not been approved by the ICC MDT will be returned to the referrer. There are 3 regional ICC MDTs: North Wales, South West Wales and South East Wales. Referrals for patients whose local cardiology services are provided from England can be made to any of the 3 regional ICC MDT s Index and Cascade Testing The process of managing genetic testing for patients, and cascade testing of families, will be undertaken by the All Wales Medical Genetics Service through its established protocols and governance arrangements. After full genetic counselling, a sample will be taken and routed to the appropriate diagnostic laboratory. The results of the test and an assessment of the significance of any mutation identified would be communicated to the ICC MDT via the AWMGS. These results will then be given to the family member by the cardiologist or genetic counsellor most closely involved with their care. In cases where a pathogenic mutation is identified, appropriate mutation testing could be arranged for relatives as required by AWMGS in consultation with cardiac specialists. For relatives living elsewhere in the UK, testing could be arranged by their local ICC service. In accordance with the Welsh Government Cross Border Protocol, this Policy applies to residents of Wales funded by Welsh Health Boards of NHS Wales. It does not apply to English residents, who, in accordance with the Cross Border Protocol are eligible for NHS care funded by the relevant English NHS organisation. In cases where samples for future cardiogenetic testing are already held in storage by the AWMGS, the AWMGS will notify the referring clinician of the implementation of the testing programme. It will be the Page 6 of 13
7 referrer s responsibility to decide whether the patient meets the criteria for testing set out above. If so, they can refer to the regional ICC MDT in the usual way. If approved by the ICC MDT, patient consent and a fresh sample will be required. In many cases the testing criteria outlined above will not be met and continued sample storage may be the most appropriate strategy Gene Testing Strategy The following genes will be tested for: Hypertrophic Cardiomyopathy: MYH7, MYBPC3, TNNT2 and TNNI3 genes. Long QT syndrome: KCNQ1, KCNH2, KCNE1, KCNE2 and SCN5A genes. Catecholaminergic Polymorphic Ventricular Tachycardia: RYR2 gene. Due to the rapid advances taking place in genetic testing, new genes may be discovered for the above conditions at any time. Where additional genes for these conditions may be tested for as part of routine testing practice, and without significant additional cost, they will be included within the gene testing strategy Laboratory Testing Samples for cardiogenetic testing will be sent to laboratories in England. These laboratories will be selected on the basis of price competitiveness and service quality. 2.2 Care Pathway Figure 1 below shows the care pathway for genetic testing for inherited cardiac conditions. Page 7 of 13
8 Figure 1: Care pathway for genetic testing for inherited cardiac conditions All Wales Cardiac-Genetics Patient (Proband) Referral Pathway Local Cardiology Services Initial Cardiac Assessment Occurs in Cardiology Cardio-Genetic MDTs NW, SWW, SEW All Wales Medical Genetic Service MDT Risk Stratification by Cardiology with Genetics AWMGS Gene Testing of Probands &Cascade Testing Gene +ve Gene +ve Gene Testing of Probands Gene -ve Gatekeeping Steps AWMGS Cascade Testing Gene -ve Discharged Page 8 of 13
9 3. Quality and Patient Safety 3.1 Quality and Patient Safety The Provider must work to written quality standards and provide monitoring information to the lead purchaser. The centre must enable the patient s, carer s and advocate s informed participation and be able to demonstrate this. Provision should be made for patients with communication difficulties and for children. 3.2 Quality Indicators (Standards) The Provider must work to written quality standards and provide monitoring information to the lead purchaser. Providers are expected to comply with the following: Serious incidents reported externally to STEIS, Welsh Government or equivalent must be shared at time of reporting; and Annual information to be received regarding: o Number of serious incidents reported externally o Number of concerns received, response timescales, lessons learnt and action plans o Patient Experience o Compliance with safety notices e.g. NRLS Rapid Response Reports This service will be subject to the AWMGS governance protocols and standards. 3.3 Putting Things Right: Raising a Concern Whilst every effort has been made to ensure that decisions made under this policy are robust and appropriate for the patient group, it is acknowledged that there may be occasions when the patient or their representative are not happy with decisions made or the treatment, including tests, provided. The patient or their representative should Page 9 of 13
10 be guided by the clinician, or the member of NHS staff with whom the concern is raised, to the appropriate arrangements for management of their concern: When a patient or their representative is unhappy with the decision, of the gatekeeper, that the patient does not meet the criteria for treatment, including tests, and that the patient is not an exceptional case, the patient and/or their representative has a right to ask for this decision to be reviewed. The review should be undertaken, by the patient's Local Health Board, in line with section 7 of the All Wales Policy: Making Decisions on Individual Patient Funding Requests; When a patient or their representative is unhappy with the care provided during the treatment, including tests, or the clinical decision to withdraw treatment provided under this policy, the patient and/or their representative should be guided to the LHB for NHS Putting Things Right. For services provided outside NHS Wales the patient or their representative should be guided to the NHS Trust Concerns Procedure with a copy of the concern being sent to WHSSC. Page 10 of 13
11 4. Performance Monitoring and Information Requirements 4.1 Performance Monitoring WHSSC will be responsible for commissioning services in line with this service specification. This will include agreeing appropriate information and procedures to monitor the performance of organisations. For the service defined in this specification, the following approach will be adopted: An annual report will be provided by the AWMGS to WHSSC that will include the following: o Number of referrals by diagnosis, referring MDT and LHB of residence o Number of index tests undertaken by diagnosis, referring MDT and LHB of residence o Number and percentage of positive index test results by diagnosis o Number of cascade tests undertaken (in total and per index test); numbers of cascade test positive and negative findings o Expenditure on genetic tests by regional MDT o Comment on service issues: what has worked well and any service/pathway issues that may have arisen that affect the operation of the service o Information to describe patient outcomes (e.g. patient stories to illustrate impact of both gene negative and positive findings) The annual report should be submitted in June to cover the period of the previous financial year. The following will be reported to WHSSC by the AWMGS on a monthly basis by region: o Number of index tests undertaken o Number of family cascade tests undertaken o Financial position o Waiting list Page 11 of 13
12 Data from the cardiogenetics service will be presented by a member of the ICC MDTs at the annual Cardiac Audit Day held in November each year. 4.2 Key Performance Indicators The providers will be expected to monitor against the following target outcomes on an annual basis: Percentage positive index tests (target level: 50%) Average number of cascade tests per index case Page 12 of 13
13 5. Equality Impact and Assessment The Equality Impact Assessment (EQIA) process has been developed to help promote fair and equal treatment in the delivery of health services. It aims to enable Welsh Health Specialised Services Committee to identify and eliminate detrimental treatment caused by the adverse impact of health service policies upon groups and individuals for reasons of race, gender re-assignment, disability, sex, sexual orientation, age, religion and belief, marriage and civil partnership, pregnancy and maternity and language (welsh). This policy has been subjected to an Equality Impact Assessment. The assessment has shown that there will be no impact. Page 13 of 13
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