Schedule 2 Part A Service Specification

Service Specification No. / 04
Service / Anti-coagulation Monitoring Levels 3, 4 & 5(Warfarin only)
Commissioner Lead / Alastair Mew/Dr Zak McMurray
Provider Lead
Period / April 2016 – March 2017
Date of Review / September 2016
1.Population Needs
1.1 National/local context and evidence base
Warfarin is used in the management of anumber of conditions including; 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 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
2.1NHS Outcomes Framework Domains & Indicators
Domain 1 / Preventing people from dying prematurely / X
Domain 2 / Enhancing quality of life for people with long-term conditions / X
Domain 3 / Helping people to recover from episodes of ill-health or following injury / x
Domain 4 / Ensuring people have a positive experience of care
Domain 5 / Treating and caring for people in safe environment and protecting them from avoidable harm
2.2 Local defined outcomes
Outcome / Demonstrated by
Patient care closer to home / Patients receiving treatment at a site locally convenient to them.
Improved patient choice / Patient has the option to be seen at a site locally convenient to them.
Reduction in secondary care activity. / Patients managed treated in the community
where appropriate.
3.Scope
3.1Aims 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 level 5 practices are able to initiate therapy for patients identified as having atrial fibrillation and, after discussions with the patient; warfarin is the anticoagulant of choice. (See Local Stroke Prevention in Non-Valvular Atrial Fibrillation- SPAF guidelines
Where care is initiated in secondary care there is a recognised mechanism which safely transfers the monitoring responsibility from one organisation to another, therapy should normally be 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;
  1. The patients INR should be controlled within the agreed INR range;
  2. The service to the patient is convenient;
  3. The need for continuation of therapy is reviewed regularly and discontinued when appropriate;
  4. For patientswith atrial fibrillation and who have sub-optimal INR control (defined as; one INR above 8 or 2 INR readings above 5 or 2 INR readings less than 1.5 with the last 6 months or Time in Therapeutic Range (TTR) less than 65%) should be considered for a DOAC, within its licensed indication. See local SPAFguidelines.
3.2Service description/care pathway
  1. The practice 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.
The practice delivering this LCS will be expected to comply with these recommendations and where any patients are not being monitored by the practice the patient clinical record clearly states who is responsible, and should show evidence that appropriate monitoring is taking place. All practices should use appropriate Clinical Decision Support Software (CDSS) e.g. INR Star as approved by Sheffield CCG. The practice is now responsible for ensuring all appropriate licences are in place, dependant on the level of service being provided. The cost of the licence/s has now been incorporated into the ‘per patient payment’ If practices do not use appropriate CDSS, then they should be able to provide a clear description of how dosing changes are made by the responsible clinicians. They should be able to provide the necessary information in support of the audit criteria detailed in schedule 4 part c.
For those practices providing INR testing at level 4, the meters used should meet the agreed standards for medical devices. Most practices are using Roche meters and are encouraged to use the Coagucheck XS Plus meter. Roche will provide training on use and, in addition, have agreed a cluster based discount for Sheffield practices purchasing the testing strips.
At those practices where patients have bought their own meters and the practice is providing the dosing advice and guidance, the practice shouldensure that the patient is using the meter correctly, that it is reading accurately and if necessary should have a check made against a venous sample or quality control test on at least an annual basis. For payment purposes, these patients should be classed as Level 3
The register will include:
  • The patient’s name and date of birth;
  • The indication for and duration of treatment;
  • Read code consultation (include specific read codes);
  • Computerised linkage of medication to indication for treatment;
  • Target INR must be recorded;
  • Relevant clinical history, examination findings and test results;
  • Follow up arrangements (should include “including evidence of a robust call and recall system”).
We would strongly recommend that these entries above are in both the patients’ substantive clinical record as well as captured in the register plus where used, the CDSS system.
  1. Call and recall. To ensure that systematic call and recall of patients on this register is taking place in a primary care setting;
  2. Professional links. To work together with other professionals where appropriate. Any health professionals involved in the care of patients should be appropriately trained;
  3. 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;
  4. Education of newly diagnosed patients. To ensure that all newly diagnosed patients (and/or their carers and support staff where appropriate) receive appropriate management and prevention of secondary complications of their condition, including the provision of a patient-held booklet. The patient information leaflet to be used is available via the NPSA.
  5. 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).
  6. Clinical procedures. To ensure that at initial diagnosis, and at least annually, an appropriate review of the patients 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 relating to the LCS is recorded in the patient’s own GP-held lifelong record, including completion of the ‘significant active problem’ record that the patient is on warfarin;
  7. Record keeping. To maintain adequate records of the performance and result of the service provided. This should include the number of ‘bleeding episodes’ requiring hospital admission and deaths caused by anti-coagulants;
  8. Initiation (level 5 provision). Where the service is provided by a GP, he or she may initiate warfarin for treatment of 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 CCG’s Standard Operating Procedure.
  9. NPSA Alert.The National Patient Safety Agency has issued guidance that must be used in conjunction with this specification.
  10. Clinical Audit.All practices must undertake an annual clinical audit as detailed in schedule 4 part c. A standard data collection form for the clinical audit will be distributed to providers and this must be completed and returned to the Clinical Audit & Effectiveness Team at Sheffield CCG. The timescales and process for forwarding audit results will be notified to the provider by the commissioner. Outcomes of audits may be discussed with practices.Practices are expected to use best practice when recording data. Please address any data quality queries to the Data Quality Team at Sheffield CCG;
  11. CDSS. Sheffield CCG encourages all providers to use INR Star and the costs for this 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 INR Star are incorporated into the payment fee. Practices are responsible for ensuring licenses are in place and are kept up to date;
  12. NEQAS. The CCG requires providers using near patient testing equipment to participate in the National External Quality Assurance Scheme (NEQAS) Web Based, and the license cost for this are incorporated in the ‘per patient payment’. Again, practices are responsible for ensuring licenses are in place and are kept up to date;
  13. Accreditation/Training. Those doctors who have previously provided an anticoagulation monitoring service similar to this one, and have such continuing medical experience, training and competence as is necessary to enable them to contract for the locally commissioned service shall be deemed professionally qualified to do so. Doctors, Pharmacists, and Nurses new to providing an anticoagulation monitoring service must attend an approved course. Only trained clinicians can prescribe or agree any dosing. All providers must ensure that clinicians providing the service have also received training to use the CDSS;
  14. Inter Practice Referrals. Where the service is provided by someone other than the patient’s own practice, the provider must ensure that the patients registered GP is given this information, after obtaining explicit consent from the patient.
3.3Population covered
This service will be available to every patient in Sheffield eligible for primary care monitoring of anticoagulation therapy.
3.4Any acceptance and exclusion criteria and thresholds
Please see Anticoagulation Standard Operating Procedures.

3.5Interdependence with other services/providers
Therapy should normally be initiated in secondary care, for recognisedindications for specified lengths of time. There is a recognized mechanism for safe transfer of care between secondary and primary care providers.
4.Applicable Service Standards
4.1Applicable national standards (e.g. NICE)
4.2Applicable standards set out in Guidance and/or issued by a competent body (e.g. Royal Colleges)
4.3Applicable local standards
Practices are funded for a maximum of 12 home visits per patient per year for INR levels 3 & 4 only
5.Location of Provider Premises
The Provider’s premises are located at:
Individual GP Practices, community pharmacies

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