Service Specification Template Department of Health, updated June 2015

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1 Service Specification Template Department of Health, updated June 2015 Service Specification No. : 2 Service: Commissioner Lead: Provider Lead: Period: Anti-coagulation monitoring Date of Review: 31 st September Population Needs (Mandatory) 1.1 National/local context and evidence base Paul Baker, Deputy Director of Commissioning 1 st April st March 2017 (3 months notice will be required to terminate this contract by either party) Warfarin is being used in the management of increasing numbers of patients and conditions including patients post - myocardial infarction, 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 target 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. Anti-coagulation monitoring in GP practices enables patients to receive an important service in a local, convenient location. It is also generally considered to be safer by reducing the number of interfaces by which results and dosing are communicated. 2. Outcomes 2.1 NHS Outcomes Framework domains & Indicators https://www.wp.dh.gov.uk/publications/files/2012/11/ nhs-outcomes-framework pdf Domain 1 Domain 2 Domain 3 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 Potential Years of Life Lost from causes amenable to healthcare Reducing premature mortality from the major causes of death Reducing premature death in people with serious mental illness Reducing deaths in babies and young children Reducing premature death in people with a learning disability Health related quality of life for people with long term conditions Ensuring people feel supported to manage their condition Improving functional ability in people with long-term conditions Reducing time spent in hospital by people with long term conditions Enhancing quality of life for people with mental illness Enhancing quality of life for people with dementia Emergency admissions for acute conditions that should not usually require hospital admission Emergency readmissions within 30 days of discharge from hospital Improving outcomes from planned treatments Preventing lower respiratory tract infections in children from becoming serious Improving recovery from injuries and trauma Improving recovery from stroke Improving recovery from fragility fractures Helping older people recover their independence after illness or injury

2 Domain 4 Domain 5 Ensuring people have a positive experience of care Treating and caring for people in safe environment and protecting them from avoidable harm Patient Experience of Primary Care (GP services/gp Out of Hours/NHS Dental Services Patient Experience of Hospital Care Friends and Family Test Improving people s experience of out-patient care Improving hospitals responsiveness to personal needs Improving access to primary care services Improving women and families experience of maternity services Improving the experience of care of people at the end of their lives Improving experience of healthcare for people with mental illness Improving children and young people s experience of healthcare Improving people s experience of integrated care Patient Safety Incidents Reported (safety incidents involving severe harm or death/hospital deaths attributable to problems in care) Reducing the incidence of avoidable harm Improving the safety of maternity services Delivering safe care to children in acute settings 3. Scope 3.1 Aims and objectives of service 3. Scope (Mandatory) An anti-coagulation monitoring service is designed to be one in which: therapy can be initiated in secondary or primary care, for recognised indications for specified lengths of time; maintenance of patients INR levels should be properly controlled; the service to the patient is convenient and safe; the need for continuation of therapy is reviewed regularly; the therapy is discontinued when appropriate. 3.2 Service description/care pathway This service funds: The development and maintenance of a register. Practices should be able to produce an up-to-date register of all anti-coagulation monitoring service patients, indicating patient name, date of birth, the indication for and length of, treatment and the target INR. Call and recall. To ensure that systematic call and recall of patients on this register is taking place either in a hospital or general practice setting. Professional links. To work together with other professionals when appropriate. Any health professionals involved in the care of patients in the programme should be appropriately trained. 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 Education of newly diagnosed patients. To ensure that all newly diagnosed patients (and/or their carers and support staff when appropriate) receive appropriate management of, and prevention of, secondary complications of their condition including the provision of a patient-held booklet. To prepare with the patient an individual management plan, which gives the diagnosis, planned duration and therapeutic range to be obtained. Clinical procedures. To ensure that at initial diagnosis and at least annually an appropriate review of the patient s health is carried out including checks for potential complications and, as necessary, a review of the patient s own monitoring records. To ensure that all clinical information related to the service is recorded in the patient s own GP held lifelong record, including the completion of the significant record that the patient is on warfarin. Record-keeping. To maintain adequate records of the performance and result of the service provided, incorporating appropriate known information, as appropriate. This may include the number of bleeding episodes requiring hospital admission and deaths caused by anti-coagulants.

3 Audit. To carry out clinical audit of the care of patients against the above criteria, including untoward incidents. This should also review the success of the practice in maintaining its patients within the designated INR range as part of quality assurance. Provision of test strips are EXCLUDED from this specification with separate arrangements applying under which the CCG makes payment direct to suppliers. Practices are though requested to propose to CCG any changes as regards strip ordering for agreement prior to making such Training. Each practice must ensure that all staff involved in providing any aspect of care under this scheme have the necessary training and skills to do so. Review. All practices involved in the scheme should perform an annual review which could include: information on the number of patients being monitored, the indications of anticoagulation, i.e. DVT etc, and the duration of treatment brief details as to arrangements for each of the aspects highlighted above details of any computer-assisted decision-making equipment used and arrangements for internal and external quality assurance details of any near-patient testing equipment used and arrangements for internal and external quality assurance details of training and education relevant to the anti-coagulation monitoring service received by practitioners and staff details of the standards the practice uses for the control of anti-coagulation. 3.3 Population covered Patients registered with the GP practice. 3.4 Any acceptance and exclusion criteria Section of the South Devon Joint Formulary relates to Oral Anti-Coagulants and provides guidance on indications. The formulary is available here: 3.5 Interdependencies with other services Includes community nursing, hospital discharge, MAT team and haematology/dvt clinics. 4. Applicable Standards Service Standards (Mandatory) 4.1 Applicable national standards eg NICE, Royal College The following NICE guidance and quality standards relate to anticoagulation therapy: Atrial fibrillation Apixaban for the prevention of stroke and systemic embolism in people with non-valvular atrial fibrillation. NICE technology appraisal guidance 275 (2013). WatchBP Home A for opportunistically detecting atrial fibrillation during diagnosis and monitoring of hypertension. NICE medical technology guidance 13 (2013). Rivaroxaban for the prevention of stroke and systemic embolism in people with atrial fibrillation. NICE technology appraisal guidance 256 (2012). Dabigatran etexilate for the prevention of stroke and systemic embolism in people with atrial fibrillation with one or more risk factor for stroke or systemic embolism. NICE technology appraisal guidance 249 (2012). Percutaneous occlusion of the left atrial appendage in non-valvular atrial fibrillation for the prevention of thromboembolism. NICE interventional procedures guidance 349 (2010). Atrial fibrillation: the management of atrial fibrillation. NICE clinical guideline 36 (2006).

4 Venous thromboembolism NICE guidance on VTE as set out in the NICE pathway on venous thromboembolism including quality standards for VTE prevention and diagnosis and management of venous thromboembolic diseases. Further NICE guidance is also in development on rivaroxaban for pulmonary embolism and dabigatran etexilate for venous thromboembolic events. Other Stroke pathway: a fast, easy summary view of NICE guidance on stroke, including primary and secondary prevention of stroke. Medicines adherence: involving patients in decisions about prescribed medicines and supporting adherence. NICE clinical guideline 76 (2009). A link to these standards is available here: 4.2 Applicable standards set out in Guidance and/or issued by a competent body (e.g Royal Colleges The British Committee for Standards in Haematology issued Guidelines on oral anticoagulation with warfarin - 4th edition, in They are available here: 4.3 Applicable local standards Section of the South Devon Joint Formulary relates to Oral Anti-Coagulants and provides guidance on indications. The formulary is available here: 5. Key Service Outcomes (Mandatory) 5. Key Service Outcomes (Mandatory) The service is designed to offer patients a high quality service that is conveniently located and cost-effective. NICE suggest that commissioning anticoagulation therapy, in line with NICE guidance and NICE quality standards, may contribute to achieving the outcomes below. NHS outcomes framework 2012/13 Domain 3 improving outcomes from planned treatments (see section 3.1.1) and improving recovery from injuries and trauma (see section 3.1.3) Domain 5 treating and caring for people in a safe environment and protecting them from avoidable harm Public health outcomes framework for England Domain 4 healthcare, public health and preventing premature mortality CCG outcomes indicator set Domain 1 under 75 mortality from cardiovascular disease; under 75 mortality from cancer Domain 2 ensuring people feel supported to manage their condition Domain 5 patient safety incidents reported Quality and outcomes framework (QOF) The percentage of patients with atrial fibrillation in whom stroke risk has been assessed using the CHADS2 risk stratification scoring system in the preceding 15 months (excluding those whose previous CHADS2 score is greater than 1) In patients with atrial fibrillation in whom there is a record of a CHADS2 score of 1 (latest in the preceding 15 months), the percentage of patients who are currently treated with anticoagulation drug therapy or anti-platelet

5 therapy. In patients with atrial fibrillation whose latest record of a CHADS2 score is greater than 1, the percentage of patients who are currently treated with anticoagulation therapy 6. Applicable quality requirements and CQUIN goals 6.1 Applicable quality requirements It is a condition of participation in this service that practitioners give notification of all emergency admissions or deaths of any patient covered under this service, where such admission or death is or may be due to usage of the drug(s) in question. This must be reported to the CCG quality and safety team as a significant even. This is in addition to a practitioner s statutory obligations. We would normally expect practices to have in place the following: A named clinical lead (which could be a nurse); Relevant protocols and standard operating procedures; A record of training undertaken by those involved with the service; Decision support software; Arrangements for Quality Assurance (QA) covering Internal Quality Control (IQC) and External Quality Assurance (EQA); Patient education and support materials. NICE recommended quality requirements include: Time within target INR range (for those that have been on an anticoagulant for >6 weeks, a minimum of 60% in TTR and ideally 65%). Providers should have in place systems to identify patients who have missed their monitoring appointment and promptly follow them up. 7. Financial Requirements The CCG will not commission an anti-coagulation monitoring service at either level 1 or 2. The expectation in south Devon and Torbay is that most testing will be level 4. Payments are as follows: Level 3 Practice-funded phlebotomist or pharmacist, practice sample, laboratory test, practice dosing 90 per patient per year (South Devon practices, by exception only) Level 4 Practice-funded phlebotomist or pharmacist, practice sample, practice test, practice dosing 105 per patient per year These prices are all-inclusive of all necessary requirements to provide the service as specified with the exception of testing strips, which are currently funded directly by the CCG to the supplier (Roche). The prices include the timely provision of activity, quality and performance information. 8. Information Requirements An annual report will be required from the provider which includes as a minimum: information on the number of patients being monitored, the indications of anticoagulation, i.e. DVT etc, and the duration of treatment brief details as to arrangements for each of the aspects highlighted above details of any computer-assisted decision-making equipment used and arrangements for internal and external quality assurance details of any near-patient testing equipment used and arrangements for internal and external quality assurance

6 details of training and education relevant to the anti-coagulation monitoring service received by practitioners and staff details of the standards the practice uses for the control of anti-coagulation. The collated information from these reports will be considered by the CCG Quality Committee. 9. Location of Provider Premises (Mandatory) The practice name and address as specified in the primary medical services contract. 10. Period of Notice Three months notice will be required by either party for termination of this contract. 9. Location of Provider Premises (Mandatory)

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