Schedule 2 Part A Service Specification Service Specification No. 04 Service Anti-coagulation Monitoring Levels 3, 4 & 5 Commissioner Lead Provider Lead Linda Cutter / Dr Charles Heatley GP Practices and Community Pharmacies Period April 2017 March 2018 Date of Review September 2017 1. Population Needs 1.1 National/local context and evidence base Warfarin is being used in the management of increasing numbers of patients and conditions including patients with atrial fibrillation, DVTs and other disorders. While it is a very effective drug in these conditions, it can also have serious side effects, e.g. severe haemorrhage. These side effects are related to the International Normalised Ratio (INR) level, which measures the delay in the clotting of the blood caused by the warfarin. While the normal INR is 1, the specific range of INR values depends on the disease and the clinical conditions. Warfarin monitoring aims to stabilise the INR within set limits to help prevent serious side-effects while maximising effective treatment. 2. Outcomes 2.1 NHS Outcomes Framework Domains & Indicators Domain 1 Domain 2 Domain 3 Domain 4 Domain 5 Preventing people from dying prematurely Enhancing quality of life for people with long-term conditions Helping people to recover from episodes of ill-health or following injury Ensuring people have a positive experience of care Treating and caring for people in safe environment and protecting them from avoidable harm X x X 2.2 Local defined outcomes Outcome Patient care closer to home Improved patient choice Reduction in secondary care activity. Demonstrated by Patients receiving treatment at a site locally convenient to them. Patient has the option to be seen at a site locally convenient to them. Patients managed in primary care where appropriate. 1
3. Scope 3.1 Aims and objectives of service An anticoagulation monitoring service is designed to be one in which: i. Patients will usually be initiated on warfarin in a secondary care setting though many practices will be happy to initiate therapy for patients identified as having atrial fibrillation. Where warfarin treatment is initiated in secondary care for recognised indications for specified lengths of time, there is a recognised mechanism for safe transfer of care between secondary and primary care providers; ii. The patients INR should be controlled within the agreed range; iii. The service to the patient is convenient; iv. The need for continuation of therapy is reviewed regularly and discontinued when appropriate; v. Patients with atrial fibrillation who have sub-optimal INR control (see unstable anticoagulation criteria below) are considered for one of the newer direct acting oral anticoagulants (NOACs or DOACs) Unstable anticoagulation criteria (NICE CG180) Any one of: 2 INRs >5 in the last 6 months 1 INR >8 in the last 6 months 2 INRs <1.5 in the last 6 months (without planned interruptions) Time in therapeutic range <65% 3.2 Service description/care pathway The provider delivering this LCS will be expected to comply with these recommendations; i. Patient register. The provider is required to maintain a register of all patients on warfarin and as a minimum this should reference the clinical reason for warfarinisation. It is recommended that the target INR is captured in the clinical record. Where any patients are not monitored by the practice the patient clinical record clearly states who is responsible, and should show evidence that appropriate monitoring is taking place. Read codes for secondary care monitoring are: Anticoagulation monitoring secondary care XaL3h (SystmOne) Anticoagulation monitoring secondary care - 66QC (EMIS Web) The register for patients being monitored by the provider will include, where applicable: The patient s name and date of birth; The indication for and duration of treatment; Computerised linkage of medication to indication for treatment; Target INR must be recorded; Relevant clinical history, examination findings and test results; Read codes for monitoring: 2
SystmOne Read codes are as follows; Anticoagulation monitoring in primary care XaMh8 Home visit for anticoagulation monitoring XaQyK Self monitoring of INR XaNbr ii. EMIS Web read codes are as follows: Anticoagulation monitoring - primary care - 66QD Home visit for anticoagulation monitoring - primary care - 9K27 Self monitoring of INR - 66QE Follow up arrangements (should include including evidence of a robust call and recall system ). The above entries must be recorded in both the patients electronic clinical record (for GP practices) as well as in the Clinical Decision Support Software (CDSS). CDSS. All providers must use an appropriate Clinical Decision Support System (CDSS) and are advised to use the web based INRstar, as approved by Sheffield CCG. Level 1A evidence from the British Committee for Standards in Haematology guidelines on oral anticoagulation with warfarin (2011) states that computer-assisted dosing is superior to manual dosing for patients on warfarin. The costs for the CDSS are built into the per patient payment. Providers may opt to use other approved CDSS but where this is more expensive only the equivalent costs of INRstar are incorporated into the payment fee. Providers are responsible for ensuring all appropriate licences are in place, dependant on the level of service being provided and licences are kept up to date. iii. Meters. For those providers undertaking INR testing at level 4, the meters used should meet the agreed standards for medical devices. Most providers are using Roche meters and are encouraged to use the CoaguChek XS Plus meter. Roche will provide training on use and, in addition, have agreed a cluster based discount for Sheffield providers purchasing the testing strips. Testing strips must not be prescribed on FP10, except for patients who are self-monitoring. Where patients have bought their own meters and the provider is giving dosing advice and guidance, the provider is required to ensure that the patient is using the meter correctly; check against a venous sample or quality control test on at least an annual basis; these patients should be classed as Level 3. iv. Call and recall. To ensure that systematic call and recall is in place for patients being monitored by the provider. v. Professional links. To work together with other professionals where appropriate. Any health professionals involved in the care of patients should be appropriately trained. vi. Referral policies. When appropriate, to refer patients promptly to other necessary services and to the relevant support agencies, using locally agreed guidelines where these exist. vii. Education. To ensure education of patients (and/or their carers and support staff where appropriate) regarding their warfarin therapy, including the provision of a patient-held booklet. The NPSA patient information booklet should be used. 3
viii. Individual management plans. To prepare with the patient an individual management plan which gives the diagnosis, planned duration and therapeutic range to be obtained (e.g. the yellow book). ix. Clinical procedures. To ensure that at initial diagnosis, and at least annually, an appropriate review of the patient s health is carried out. This includes checking for potential complications and a review of the patient s monitoring records. To ensure that all clinical information relating to the LCS is recorded in the electronic patient record. x. Record keeping. To maintain adequate records, using the CDSS, to evaluate the performance and result of the service provided. This should include the number of bleeding episodes requiring hospital admission and deaths caused by anticoagulants. xi. Initiation (level 5 provision). Where the service is provided by a GP, they may initiate warfarin for thromboprophylaxis in atrial fibrillation. This is an optional element of the service for which a separate one-off payment is made, to cover the costs of the additional consultations required to stabilise the patient. The dosing guidelines to be followed for initiation are included in the Sheffield CCG s Anticoagulation Monitoring Service Standard Operating Procedure xii. NPSA Alert. The National Patient Safety Agency has issued guidance that must be used in conjunction with this specification. http://www.nrls.npsa.nhs.uk/resources/?entryid45=59814&q=0%c2%acwarfarin%c2% ac xiii. Clinical Audit. All providers must agree to Sheffield CCG accessing provider level data through INRstar Analytics on at least a quarterly basis; this is for clinical audit and quality improvement purposes as detailed in schedule 4 part c. Individual provider data and anonymised reports will be sent to providers. Providers will be asked to complete an action plan based on data extracted from INRstar Analytics. Outcomes of audits and data taken at the end of each quarter from INRstar Analytics may be discussed with providers. The Clinical Audit and Effectiveness Team may request action plans from providers on how recommendations have been implemented from provider based data extracted by INRstar Analytics. If providers are not using INRstar it will still be a requirement to provide the data requested by the Clinical Audit and Effectiveness Team. xiv. Consent to access provider data. By signing this contract providers are agreeing to Sheffield CCG accessing non-patient identifiable information via the INRstar Analytics computer system. xv. National External Quality Assurance Scheme (NEQAS). Sheffield CCG requires providers using near patient testing equipment to participate in the web based NEQAS. The cost for this is incorporated in the per patient payment. Providers are responsible for ensuring subscriptions are in place and are kept up to date; xvi. Accreditation/Training. Doctors, pharmacists and nurses new to providing an anticoagulation monitoring service must attend an approved course as detailed in the anticoagulation SOP. Doctors shall be deemed professionally qualified to contract for the locally commissioned service if they have: previously provided an anticoagulation monitoring service similar to this service; and have the necessary continuing medical experience, training and competency. All providers must ensure that all clinicians involved in providing the service have also received training to use the CDSS. xvii. Dosing. The doser is a registered health care professional who is suitable trained and competent in anticoagulation management. The dose of warfarin will be determined upon receipt of the INR results from the laboratories or near-patient testing equipment guided by the CDSS. Any dosing decisions to be documented within the electronic patient record and within the patients hand held record. 4
xviii. Indemnity cover. Providers are responsible for ensuring that the appropriate indemnity insurance is in place to cover all members of staff involved in service delivery. The service provider s indemnity insurance must cover HCAs, dispensers and all health-care professionals for the role they are operating with regards to anticoagulation monitoring. The Anticoagulation Monitoring Service Standing Operating Procedure (SOP) can be referred to for clarification of staff roles and responsibilities. xix. Inter Provider Referrals. Where the service is provided by someone other than the patient s own GP, the procedures as detailed in the Anticoagulation Monitoring Service SOP must be followed. 3.3 Population covered This service will be available to every patient in Sheffield eligible for primary care monitoring of anticoagulation therapy. 3.4 Any acceptance and exclusion criteria and thresholds Please see Anticoagulation Monitoring Service SOP. http://sheffieldccg-intranet.nhs.sitekit.net/medicines%20management/medicinesprescribing/prescribing-guidelines.htm 3.5 Interdependence with other services/providers Therapy should normally be initiated in secondary care, for recognised indications for specified lengths of time. There is a recognized mechanism for safe transfer of care between secondary and primary care providers. Please refer to the Anticoagulation Monitoring Service SOP - http://sheffieldccg-intranet.nhs.sitekit.net/medicines%20management/medicinesprescribing/prescribing-guidelines.htm 4. Applicable Service Standards 4.1 Applicable national standards (e.g. NICE) 4.2 Applicable standards set out in Guidance and/or issued by a competent body (e.g. Royal Colleges) 4.3 Applicable local standards 5. Location of Provider Premises The Provider s premises are located at: Individual GP Practices and Community Pharmacies Schedule 2 Part B Indicative Activity Plan Name of Service - Anticoagulation Monitoring levels 3, 4 and 5 Xxx cumulative total of active patients reported each month (estimated number of patients is this figure / 12) 5
Schedule 2 Part C Activity Planning Assumptions Name of Service - Anticoagulation Monitoring levels 3 and 4 Providers are funded for a maximum of 12 home visits per patient per year for INR levels 3 & 4 only Schedule 2 Part F Clinical Networks and National Programmes Schedule 2 Part G Other Locally Agreed Policies and Procedures Policy Date Weblink Anticoagulation Monitoring Service Standard Operating Procedure October 2014 (under review) Schedule 2 Part I Exit Arrangements Schedule 2 Part K Transfer of and Discharge from Care Protocols Please refer to the Anticoagulation Monitoring Service Standard Operating Procedure http://sheffieldccgintranet.nhs.sitekit.net/medicines%20manage ment/medicines-prescribing/prescribingguidelines.htm http://sheffieldccg-intranet.nhs.sitekit.net/medicines%20management/medicinesprescribing/prescribing-guidelines.htm Schedule 3 Payment Part A Local Prices Service Description Currency Price Basis for payment Level 3 Price per 13.25 per active patient month per month Level 4 Price per active patient 17.75 per month Payment is per patient paid on a quarterly basis Payment is per patient paid on a Regime for future years 6
per month quarterly basis Level 5 Price is a 50.00 Payment is per one off patient paid on a payment per quarterly basis patient initiated on warfarin for atrial fibrillation Home Visits Price per visit 6.00 Payment is per visit carried out by provider staff. A maximum of 12 visits per patient per year is permitted Please note: Additional phlebotomy costs are included at all levels. The Level 3, 4 and 5 payments are per patient (not blood tests). The Level 4 payment also includes payment for test strips and internal quality control checks. Strips must not be prescribed on FP10. Level 4 providers may opt to provide a Level 3 service to some patients where this is appropriate. Should the above circumstance arise, please inform the Contracting Team. GP providers offering a Level 3 or Level 4 service may also provide a Level 5 service. The additional payment at Level 5 is a one-off payment to cover the costs of extra consultations needed to stabilise patients and is payable only in the financial year in which warfarin is initiated. Thereafter, the normal Level 3 or 4 payment per patient will apply. Sheffield CCG will pay for home visits where completed by provider employed staff only. Payments may be subject to PPV checks and linked to audit and patients satisfaction submissions. Part B Local Variations Part F Expected Annual Contract Value Service Expected annual contract value Anticoagulation Monitoring levels 3, 4 & 5 Varies per provider see Anticoagulation Activity 7
Schedule 4 Part C Local Quality Requirements Quality Requirement Threshold Method of Measurement All patients should be monitored in line with: The CCG ANTICOAGULATION MONITORING SERVICE Standard Operating Procedure for the provision of a Level 3, 4 and 5 anticoagulation service The NPSA safety indicators for patients starting oral anticoagulant treatment. The NPSA safety indicators for patients established on oral anticoagulant treatment The service description/care pathway 100% Clinical Audit and effectiveness team to remotely extract audit data via INRstar Analytics and or provider submission of data The Clinical Audit and Effectiveness team may request service providers to submit action plans based on data extracted from INRstar Analytics or from provider submissions. Consequence of breach As per clause GC9 Monthly or annual application of consequence Quarterly 04 Applicable Service Specification Service providers may be required to submit evidence of indemnity cover if requested by Sheffield CCG. Schedule 4 Part F Local Incentive Scheme Schedule 5 Part B2 Provider s Permitted Material Sub-Contractors SCHEDULE 6 Part C Reporting Requirements Activity Information required Information required Reporting Period Format of Report Timing and Method for delivery of Report Number of patients Monthly As set out in the database Via LCS database by 8
Information required on provider register being managed at L3 & L4 Number of new initiated patients L5 Number of home visits carried out Reporting Period Format of Report Timing and Method for delivery of Report 15 th working day of the month. Monthly As set out in the database Via LCS database by 15 th working day of the month. Monthly As set out in the database Via LCS database by 15 th working day of the month. Quality Requirements Information required Information required Reporting Period Format of Report Timing and Method for delivery of Report Quality Audit Biannually Clinical Audit and effectiveness team to remotely extract audit data via INRstar Analytics or from provider submissions. Audit report to be sent out December 2017 to individual providers. Re audit report. To be sent out May 2018. Quarterly Clinical Audit and effectiveness team to remotely extract audit data via INRstar Analytics or from provider submissions. Individual provider data to be provided with areas for improvement highlighted. Providers then to use this data to inform action plans, which can be requested by Sheffield CCG. SCHEDULE 6 Part G Surveys Type of Survey Frequency Method of Reporting Method of Publication Friends and Family Test (where required in accordance with FFT Guidance) 9
Service User Survey Staff Surveys Carer Survey 10