2. Local Enhanced Service for Anticoagulation Monitoring, Levels 3, 4 and 5

2. Local Enhanced Service for Anticoagulation monitoring, levels 3, 4 and 5

Introduction

All practices are expected to provide essential and those additional services they are contracted to provide to their patients in accordance with clause 32.1 nil detriment. This local enhanced service (LES) specification outlines the more specialised services to be provided. The specification of this service is designed to cover the enhanced aspects of clinical care of the patient, all of which are beyond the scope of essential services. No part of the specification by commission, omission or implication defines or redefines essential or additional services.

This specification needs to be read alongside Sheffield PCT’s Anticoagulation Monitoring Service: Standard Operating Procedure (September 2008).

http://nww.sheffield.nhs.uk/policies/sops.php

Background

Warfarin is being used in the management of increasing numbers of patients and conditions including patient’s 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.

Service Aims

An anticoagulation monitoring service is designed to be one in which:

i. 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;

ii.  The patients INR should be controlled within the agreed INR range;

iii.  The service to the patient is convenient;

iv.  The need for continuation of therapy is reviewed regularly and discontinued when appropriate;

Definitions

‘Doser’ / prescriber means any person who is suitably trained and qualified who meets the accreditation requirements outlined below, who upon receipt of relevant information from laboratories or near-patient testing equipment, with or without computer-assisted decision-making equipment (CDSS), determines the anti-coagulant dosage for patients being treated.

Service outline

This LES will fund:

i.  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 LES 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 CDSS e.g. INR Star as approved by Sheffield PCT. 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 below.

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 is encouraged to ensure 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.

ii.  Call and recall. To ensure that systematic call and recall of patients on this register is taking place in a primary care setting;

iii.  Professional links. To work together with other professionals where appropriate. Any health professionals involved in the care of patients should be appropriately trained;

iv.  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;

v.  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.

vi.  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. The yellow book and alert card are available different languages from: http://www.nrls.npsa.nhs.uk/resources/?EntryId45=61777);

vii.  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 LES 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;

viii.  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;

ix.  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 PCT’s Standard Operating Procedure.

x.  Training. All providers must ensure that all staff involved in providing any aspect of care under this scheme have the necessary training and skills to do so. INR Star training can be accessed online via Sullivan Cuff;

xi.  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

xii.  Clinical Audit. All practices must undertake an annual clinical audit as detailed below. 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 department at Sheffield PCT. 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 PCT.

Annual Clinical Audit Criteria (Statement) – based on safety indicators identified by the NPSA / Clinical Audit standard (target standard)
Patients established on oral anticoagulation should be within INR target more than 50% of the time (via INR Star as at 31.3.12) / 100%
The practice should be able to demonstrate appropriate action has taken place for INR 5-8, e.g. review of patient within 1 week / 95%
Practices should be able to demonstrate consideration of administration of vitamin k and monitoring of patient within 2 days and/or admission for INR >8. Recommend review under SER. / 100%
Patients established on oral anticoagulation should be given written dosage instructions at each clinic visit / 100%
Annual Service Return Criteria (Statement) – based on safety indicators identified by the NPSA
Providers must ensure that all staff involved in providing any aspect of care under the scheme has the necessary training and skills
All new non-GP practitioners must have completed an accredited course to provide an anticoagulation service
Providers must have an up to date Standard Operating Procedure (SOP) for Anticoagulation
All staff involved in providing the anticoagulation service must follow the SOP for Anticoagulation
Patients should not be accepted on the LES scheme without completed transfer documentation from secondary care as described in the SOP
Practices should have a call/recall system which captures any patient who fails to attend for follow up
Patients established on oral anticoagulation should have their diagnosis recorded
Patients established on oral anticoagulation should have their target INR recorded
Patients established on oral anticoagulation should have their stop date recorded
Patients established on oral anticoagulation should not go past their stop date
Patients established on oral anticoagulation should be given written dosage instructions at each clinic visit
Newly diagnosed patients should have a patient held record
All new patients transferring in to the scheme should have the agreed documentation completed
Providers must provide details of machines used to deliver the service, and confirmation that all relevant licences are held
Providers must be able to evidence monthly calibration of all machines used to deliver the service. ( A minimum of x3 NEQAS reports are to be submitted along with details on the steps taken to address any anomalies.)
Level 5 only
Patients starting on oral anticoagulation should follow a slow start protocol / 75%
Patients who suffer a major bleed in the first month of therapy should be the subject of an SER / 100%
Patients starting on oral anticoagulation should be issued with patient-held information / 100%
Patients established on oral anticoagulation should be given written patient information / 100%

Accreditation

Those doctors who have previously provided an anti-coagulation 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 enhanced service shall be deemed professionally qualified to do so.

Doctors new to providing an anti-coagulation monitoring service will be expected to attend an approved course and asked to undertake an audit within 6 months of commencing the new service.

Pharmacists must have completed an approved course for practitioners undertaking anticoagulant monitoring in primary care, in addition to meeting the audit requirements of new and established providers above.

Nurses must have completed an approved course for practitioners undertaking anticoagulant monitoring in primary care and be identified on page 3 of this document.

Reporting and Payment

Providers are requested to report how many active patients on the register, within the reporting month, via the Enhanced Service web-based monthly reporting system. Further information on this can be found in Schedule 4, (Activity & Finance).

Payment is per patient (not per blood test).

Sheffield PCT encourages all providers to use INR Star and the licence costs for this has now been 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 now responsible for ensuring all licences are in place and kept up to date.

The PCT also requires all providers using near-patient testing equipment to participate in the National External Quality Assurance Scheme (NEQAS) Web Based, and the licence costs for this has now been built into the ‘per patient payment’. Again, practices are now responsible for ensuring all licences are in place, and kept up to date.

Providers are expected to cover the costs of the equipment required, such as the XS Coagu Check Meters and testing strips for level 4.

Service provided / Definition of service and guidance notes for reporting. / Payment per year / Payment per month
Level 3 / Practice-funded phlebotomist or pharmacist, practice sample, laboratory test, practice dosing. / £159.60 / £13.25
Level 4 / Practice-funded phlebotomist or pharmacist, practice sample, practice dosing. / £213.00 / £17.75
Level 5 / Initiation of warfarin for atrial fibrillation (one off payment per financial year). / £50.00 / £50.00
Home Visits / Practices are funded for a maximum of 12 home visits per patient per year, which should be carried out by practice staff. / £6.00 per visit
Please note:
·  Additional phlebotomy costs are included at all levels;
·  The Level 3, 4 and 5 payments are per patient (not blood tests);
·  For reporting purposes, practices should submit information on ‘active patients’ on a monthly basis via the Enhanced Services web based monthly reporting data system;
·  For Level 3 and 4 payments the practice will be paid for the cumulative monthly activity for that payment quarter;
·  The Level 4 payment also includes payment for test strips and internal quality control checks. Strips should 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 Primary Care team in order that this activity can be accounted for. The numbers managed at each level will be monitored monthly by Sheffield PCT and payment made quarterly at the appropriate level;
·  GP providers offering a Level 3 or Level 4 service may also provide a Level 5 service if they wish and meet the accreditation requirements outlined above. 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 PCT will pay for visits where completed by practice employed staff only;
·  Payments may be subject to PPV checks and linked to audit and patients satisfaction submissions.