Camden Clinical Commissioning Group Reporting Mechanism/Frequency Remotely/Quarterly

Universal Offer Service Anticoagulation - Warfarin Clinical Lead Dr Kevan Ritchie Commissioner Camden Clinical Commissioning Group Reporting Mechanism/Frequency Remotely/Quarterly Payment Frequency Quarterly in arrears Payment Contact camdenlcs@nhs.net This Version Anticoagulation Warfarin Spec 2017-19 v1 Date 27 June 2017 Review date March 2018 Service Specification for Anticoagulation Warfarin Level 4 Service 2017-19 (part of Universal Offer) 1. Service aims 1.1. The primary care anticoagulation warfarin service in Camden is a Universal Offer service supported by clinical governance provided by the Royal Free Hospital (RFH). The primary care service is aimed at offering a cost-effective, standardised and clinicallyeffective service for patients on Warfarin with a stable INR (International Normalised Ratio) that meet the inclusion criteria set out in this specification. 2. Duration 2.1. The service will take effect from April 2017 for primary care providers already delivering the service; each provider newly joining the service after that date will agree their own start date with the CCG. 2.2. In line with NPSA guidelines, the service will undergo continuous review and adjustment as appropriate. 3. Eligibility criteria 3.1. Eligibility to Contract Criteria - All general practice primary care providers working under this Local Enhanced Service must be registered with the Care Quality Commission (CQC). 3.2. Providers must agree to all standards as laid out in this specification together with the detailed guidelines. (Appendix 1) 3.3. All primary care providers working under this service must: 3.3.1. Have a system in place for patients to receive urgent medical advice relating to their treatment; 3.3.2. Fully comply with the requirements of the clinical governance package commissioned by Camden CCG from the Royal Free Hospital including training Anticoagulation LES Spec 2016-2017 v1.0 1

and ongoing learning and competency assessment, audits, reporting of incidents, implementation of remedial action plans, and annual practice visits (Appendix 2,3); 3.3.3. Be fully compliant with the Camden CCG Readiness Assurance Checklist at all times (Appendix 4); and 3.3.4. Ensure their premises are suitable and appropriately located for easy access for the provision of the patient service specified and have the following available: Machine for POCT; PC and printer; DAWN; Test strips; Quality control materials; Finger prick lancet sampling device; Gloves; Sharps bin; Clinical waste bin; Telephone; and Consultation room with hand-washing facilities. 3.3.5. Have in place a Business Continuity Plan, including provision for breakdown of equipment or software (Appendix 5); 3.3.6. Make use of the approved Computer Decision Support Software (CDSS) approved by Camden CCG; 3.3.7. Use Point of Care Testing (POCT) equipment, as supplied by the agreed supplier; 3.3.8. The POCT equipment must be registered with the National External Quality Assessment Service (NEQAS) 1 (see Appendix 2) and operated, maintained and quality assured in keeping with their and the manufacturer s guidelines. Records of internal quality assurance must be maintained and supplied to Camden CCG on request; 3.3.9. Follow anticoagulation guidelines for out-of-range INR management (Appendix 6); 3.3.10. Have an up-to-date electronic register of all patients requiring anticoagulation monitoring, indicating patient name, date of birth, NHS number, the indication for and length of treatment, including the target INR; 3.3.11. Appropriate indemnity cover is the responsibility of the service provider to cover all clinicians involved in delivery regardless of profession or designation. 3.3.12. Maintain a minimum caseload of 20 patients with corresponding service capacity. 3.4. Primary Care providers of the anticoagulation service are required to work in line with recommendations from the National Service Framework (NSF), National Institute of Clinical Excellence (NICE), the National Patient Safety Agency (NPSA), and the British Committee for Standards in Haematology (BCSH). 1 http://www.ukneqas.org.uk/content/pageserver.asp Universal Offer: Anticoagulation Warfarin Spec 2017-2019 v1 2

3.5. Initial training and competency clinicians delivering this service must have successfully completed appropriate training and competency assessment commissioned by the CCG from the Royal Free Hospital (and be assessed as competent) before commencing service provision and must be able to demonstrate continuing professional development in the area of anticoagulation for warfarin, in line with recommendations from the British Committee for Standards in Haematology (BCSH) 2 and the NPSA Alert 18. 3.6. Continuous competency through assessment and practice A minimum caseload of twenty patients must be maintained by each primary care provider. If the provider s caseload falls below twenty patients, or the named doctor has concerns about their own or a staff member s competency, they have a responsibility to report it to the Royal Free Hospital immediately to rf.acc@nhs.net and to cooperate with remedial action. If a primary care provider s caseload is lower than twenty suitable patients, for the reason that they are being cared for in a secondary care provider other than the Royal Free, the primary care provider must contact the hospital and request transfer of suitable patients. The criteria for identifying suitable patients and the transfer pathway used must be the same as set out in this specification. The provider is responsible to ensure that all clinicians delivering this service are competent to do so by participating fully in quarterly audits, each clinician to attend at least two audit meetings a year and each clinician to be present at an annual Practice visit at least once in two years annual practice visits from the Royal Free Hospital. Training through former arrangements by the legacy Camden PCT from the Whittington Hospital and delivered through a Local Enhanced Service (LES) will be deemed sufficient only if the clinician can demonstrate that they have been delivering the service continuously (Appendix 2). 3.7. Computer Decision Support Software (CDSS) DAWN will be used by the primary care provider to record INR results and dosing. 3.8. Dosing at the point of testing using point of care testing and computer decision support software (DAWN), providers will dose the patient during that visit, undertake any clinical interventions that are required and make the patient an appointment for the next visit. The risk of communication and administrative errors is thereby reduced and patient convenience is increased. 4. Service to be provided under the LES 4.1. Level of Service - To provide therapeutic anticoagulation management to Atrial Fibrillation (AF), DVT or PE patients stable on Warfarin therapy by means of Point of Care Testing (POCT) and Computer Decision Support Software (CDSS), that meet the criteria set out in this specification. 4.2. A full service defined as the taking of blood sample, determination of INR, prescribing and dosing of Warfarin will be provided to all eligible patients during a single attendance and at a frequency appropriate to clinical need. 4.3. This service is intended to support delivery of anticoagulation service in Primary Care, thereby improving patient experience by bringing it closer to patients, while enhancing 2 http://www.bcshguidelines.com/ Universal Offer: Anticoagulation Warfarin Spec 2017-2019 v1 3

safety through access to the patient s full medical record on EMIS and co-locating prescribing and monitoring. 4.4. It aims to give access to all eligible patients registered in Camden and to ensure all are treated to a common standard across the CCG and that risks to patients are minimised through continuous competency training and assessment, audit and learning, systems maintenance and contingency planning. 4.5. Patient Inclusion Criteria - To be considered for transfer to primary care, patients will be identified as being eligible for transfer from secondary care, whereby they meet the following inclusion criteria: 4.5.1. Patients with Atrial Fibrillation requiring oral anticoagulation with warfarin (CHADS2VASC2 score 1), who have achieved good anticoagulation control (time in range > 65%) three months after initiation of warfarin (excluding the first six weeks on oral anticoagulation) and are usually able to attend a primary care provider will be counselled for transfer to a primary care provider. Inclusion and exclusion criteria will be followed. 4.5.2. Patients with recurrent venous thrombosis on long term anticoagulation, excluding patients with underlying antiphospholipid syndrome. 4.5.3. Permanently housebound patients falling within the above criteria, where the primary care General Practice is able to conduct domiciliary point of care testing in a logistically feasible and sustainable way, following agreement between the patient, GP practice and RFH/UCLH provider. Most housebound patients will remain under the responsibility of district nursing and secondary care. 4.6. Patients who are usually able to attend a primary care provider for appointments will be visited at home by the primary care provider if the patient is temporarily immobilised for a period of up to three months. 4.7. Patient Exclusion Criteria - Bridging and initiation of Warfarin are excluded from this specification. 4.8. Initiation and stabilisation of patients on warfarin is commissioned from secondary care and is undertaken in outpatient anticoagulation clinics. 4.9. Patients with the following conditions/problems will be excluded from the warfarin anticoagulation provision under the Universal Offer. These patients will continue to receive treatment in secondary care: 4.9.1. Patients with antiphospholipid syndrome; 4.9.2. Patients with a mechanical cardiac valve replacement; 4.9.3. Children under the age of 18 years; 4.9.4. Patients who self-test; 4.9.5. Documented evidence of Central Nervous System (CNS) haemorrhage in the past; 4.9.6. GI bleed in the last six months; 4.9.7. Liver failure; 4.9.8. Thrombocytopenia (platelets <75 x10^9/l); Universal Offer: Anticoagulation Warfarin Spec 2017-2019 v1 4

4.9.9. Patients who have had previous monitoring problems resulting in serious clinical incident; 4.9.10. Dementia or memory problems; 4.9.11. Patients requiring hospital transport; 4.9.12. Known heredity or acquired bleeding disorder; 4.9.13. Patients regularly attending hospital for other significant medical consultations, i.e., chemotherapy/radiotherapy when their blood test can be performed as part of their care in other parts of the hospital; and 4.9.14. Those found to be incompatible for POCT. 5. Quality and safety 5.1. Contract monitoring and governance will be undertaken by the Lead Commissioner for Camden CCG. 5.2. The CCG will extract data from DAWN quarterly in arrears for payment purposes including: 5.2.1. Number of patients on register; and 5.2.2. The number of patient appointments during the designated time period. 5.3. The CCG has commissioned the Royal Free Hospital to provide clinical governance monitoring and oversight of the primary care service. Primary Care Providers are required to familiarise themselves with their clinical governance requirements under this specification and to comply with them. Quality reporting will be reviewed by the Anticoagulation Steering Group where the Lead Commissioner, who contract manages the Service, attends. 5.4. DAWN data will be shared with the Royal Free Hospital who will audit it for quality and provide assurance reports to the CCG. The Royal Free will host quarterly meetings for primary care Providers to which a trained anticoagulation Service representative from each Primary Care Provider is required to attend for the purposes of discussion and reporting on remedial actions. The data extracted for quality monitoring will include: 5.4.1. Numbers of INR checks and DNAs; 5.4.2. Frequency of monitoring; 5.4.3. % patients in INR target range; 5.4.4. % patients with INR >5.0; 5.4.5. % patients with INR >8.0; 5.4.6. % patients with INR below target range; 5.5. Clinical outcomes that will be monitored include: 5.5.1. Time in range >65%; 5.5.2. DNA <20%; 5.5.3. Frequency of follow up no less than every 56 days and on average not more often than every 28 days (unless clinically indicated); 5.5.4. Number of patients on caseload >20; and 5.5.5. Number of patients on oral anticoagulation who do not have atrial fibrillation. Universal Offer: Anticoagulation Warfarin Spec 2017-2019 v1 5

5.6. Primary care providers are required to host the Royal Free Hospital on an annual basis for a practice visit as required, and to be monitored against a governance checklist to ensure that all required systems are in place for the running of the service. The named GP lead and all staff involved in delivering the service must be in attendance. The primary care provider will have all materials ready for inspection at the visit. (Appendix 3) 5.7. All primary care providers must adhere to Care Quality Commission requirements for the following: 5.7.1. Finger-prick (capillary) sampling use of equipment; 5.7.2. Dealing with spillages; 5.7.3. Disposal of sharps; 5.7.4. Disposal of contaminated materials; 5.7.5. Needle stick injuries; 5.7.6. Staff hepatitis immunisation and testing; and 5.7.7. Infection control. 5.8. Incident reporting - All adverse incidents and near misses must be dealt with according to the primary care provider s procedures and guidelines as set out by the Care Quality Commission (CQC). In addition, primary care providers are required to report all incidents both to the CCG and the Royal Free Hospital by completing the form that can be found on the GP website at https://gps.camdenccg.nhs.uk/practicemanagement/incident-reporting and scanning and emailing it to both organisations to: Camden CCG Email: camdenlcs@nhs.net, and Quality & Clinical Effectiveness, Camden CCG Email qands.camdenccg@nhs.net; and Dr Anja Drebes, Consultant in Clinical Haematology, Royal Free Hospital Email: Rf.acc@nhs.net 5.9. Non-serious events must be reported to the CCG within five working days; more serious events must be reported within 24 hours. 5.10. The primary care provider s named clinical lead for anticoagulation must also be notified. Adverse incidents include: Clinical: 5.10.1. Any clinical event which is, or may be due to usage of warfarin, or attributable to the underlying condition, including: Bleed or thromboembolism; Apparent drug reaction or interaction; Emergency hospital admission which is, or may be, due to warfarin usage or attributable to the underlying condition; INR >8; and Unconsidered other medicine interactions. 5.10.2. Adverse incidents or near misses involving patients having surgery, dental treatment or other procedures whilst on anticoagulation therapy. 5.10.3. Death of a patient on warfarin, whatever the cause. Universal Offer: Anticoagulation Warfarin Spec 2017-2019 v1 6

Organisational: 5.10.4. Equipment failure, e.g., POCT equipment, DAWN, etc.; 5.10.5. Inadequate quality assurance of POCT equipment; 5.10.6. Communication failure, e.g., Between the secondary and primary care providers or between a patient and provider; 5.10.7. Failure to follow the Did Not Attend (DNA) pathway/referral of a patient back to secondary care as a result of non-communication with a patient for 28 days following a missed appointment (Appendix 7). Record Keeping: 5.10.8. Incorrect interpretation and/or dosage; 5.10.9. Inappropriate overriding of dosing suggestions on DAWN; 5.10.10. Inadequate safety checks at repeat prescribing; 5.10.11. Failure to discontinue anticoagulation where indicated; 5.10.12. Yellow book not kept up to date or no yellow book in place; 5.10.13. Record keeping error, e.g., Record duplication, wrong INR recorded, etc.; 5.10.14. Failure to document, poor quality documentation. 5.11. All primary care providers must be aware of their clinical and service limitations and refer back to secondary care if the management of any patient is outside his/her sphere of competence. 5.12. The service provided must meet the needs of the patients and be reflective of patients with special needs and those without English as a first language. 6. Criteria, pricing and monitoring arrangements 6.1. Payment per patient visit will be based on quarterly activity data on DAWN and will be accessed and extracted directly by the CCG towards the end of each quarter. 6.2. Anticoagulation warfarin tariff = 26.91 per patient visit. 6.3. The CCG will refund purchase of an initial two POCT kits for each new primary care provider. All other equipment, including ongoing consumable resources required for supporting POCT will be at the expense of the practice. Replacement costs for POCT kits as and when required will be at the expense of the practice. The cost of registering with NEQAS and consumables are to be funded by the practice?. 6.4. The CCG will make quarterly payments in line with other Universal Offer services. Payments will be based on DAWN activity accessed by the CCG directly. There shall be no requirement to invoice. 6.5. Primary care providers may be asked from time to time to nominate patients to comment on the CCG s draft plans to develop services or to be interviewed about their experience. 6.6. The practice will be able to demonstrate how they plan to maintain high levels of patient satisfaction. 6.7. Audit and governance Primary care providers delivering the service are required to cooperate with all aspects of the clinical governance specification commissioned by the Universal Offer: Anticoagulation Warfarin Spec 2017-2019 v1 7

CCG from the Royal Free Hospital to provide oversight of the primary care service for quality and safety purposes. Requirements of primary care providers include: 6.7.1. Participation in training and successful competency assessment prior to commencing service delivery; 6.7.2. Compliance with the readiness assurance checklist prior to commencing service delivery and assured annually; 6.7.3. Compliance with the patient transfer pathway; 6.7.4. Participation in quarterly audit/educational meetings; 6.7.5. Reporting any incidents that arise and following discussion, completing remedial action plans; 6.7.6. Participating in primary care provider-based annual visits from the Royal Free Hospital for the purposes of: Competency revalidation, auditing of the clinical environment and clinical system; The annual visit must be attended by the primary care provider s named lead doctor for anticoagulation, and the full anticoagulation service delivery team; Ensuring that all documentation and evidence is ready for viewing at the annual visit by the Royal Free Hospital team; Ensuring that the visit occurs at an interval of every 12 months. 6.8. Provision of appropriate information to patients a patient leaflet is appended to this specification available for printing (Appendix 8 Patient Leaflet). Primary care providers are required to make one available to patients at their first appointment, and to have a supply on hand in the practice to give to patients again upon request. 6.9. Clinical responsibility the service provider is clinically responsible for all patients under their care for anticoagulation monitoring and must ensure that explicit business continuity plans are in place to cover periods of clinician absence for annual or sickness leave. Each primary care provider must employ a minimum of three trained clinicians. With specific agreement with the CCG, a primary care provider may employ two trained clinicians with the proviso that they maintain a written business continuity plan with another primary care provider who agrees to deliver the service at the address that the patient normally attends in circumstances when both clinicians are concurrently unexpectedly absent, e.g., during sickness. Flexibility regarding appointments is required to facilitate access and must accommodate patients being offered the choice of a minimum of two patient appointment times in any given week. In the event of loss of contact with a patient, or failure to attend appointments, the DNA protocol set out in this specification must be adhered to. 6.10. Reliable communication and information transfer use must be made of email, specifically NHS Mail, in order to speed and secure the transfer of information and to create an audit trail. Transfer of patients from the Royal Free Hospital to primary care providers will be via NHS Mail. All transfer emails must be acknowledged within one working day. This is in keeping with the patient transfer pathway which must be adhered to in its entirety (Appendix 9, Transfer pathway). 6.11. Clinical record keeping the service provider must maintain an up-to-date record of the following information for any patient under their care for anticoagulation services: Universal Offer: Anticoagulation Warfarin Spec 2017-2019 v1 8

6.11.1. Patient s name and address 6.11.2. Date of birth; 6.11.3. Indication for anticoagulation; 6.11.4. Duration of therapy including stop date (where appropriate); 6.11.5. Details of concomitant medication and any changes; 6.11.6. Target INR and therapeutic range; 6.11.7. Dosing information; 6.11.8. Current INR and dosage; 6.11.9. Date of next appointment; 6.11.10. Relevant notes supporting dose decision, counselling and self-management; 6.11.11. Medical conditions, hospital admissions likely to affect anticoagulation such as increased risk of haemorrhage; 6.11.12. Bleeding episodes and adverse events; 6.11.13. Name of initiating consultant or GP; 6.11.14. Dates of missed appointments over the previous year; and 6.11.15. Any actions taken other than dosing and retest dates. 6.12. At each patient appointment, the patient s handheld clinical record must be appropriately maintained with the following information: 6.14 DNA 6.12.1. Patient s INR; 6.12.2. Dose of warfarin; 6.12.3. Date of next appointment; 6.12.4. Information from the patient including; 6.12.5. Unusual bleeding or bruising; 6.12.6. Adherence to treatment; 6.12.7. Other medication; 6.12.8. Changes in diet or alcohol consumption; and 6.12.9. Planned surgery. Primary care providers must have a robust patient call and recall system in place and must follow the agreed pathway for the monitoring and management of patients who fail to attend their appointments (DNAs) (Appendix 7). 7. Exit and suspension arrangements 7.1. The practice can terminate the scheme by providing one month written notice to the CCG Primary Care Team, by sending email notification to camdenlcs@nhs.net. The CCG may terminate the scheme within 28 days if, following suspension of payments the contractor fails to re-establish services according to the service specification or take appropriate action to address deficiencies within eligibility criteria. Before issuing an exit notice, the parties will meet to discuss the reason for termination. If after this meeting the reason for terminating is not resolved then the relevant partly will issue an exit notice. 7.2. Either primary care providers or the CCG can exit this agreement by providing a minimum of six months written notice. 7.3. Before issuing an exit notice, the parties will meet to discuss the reason for termination. Universal Offer: Anticoagulation Warfarin Spec 2017-2019 v1 9

7.4. If, after this meeting, the reason for terminating is not resolved, then the relevant party will issue an exit notice. 7.5. Any appeals against the termination will be dealt with by presentation to the CCG Contract Review Committee. 7.6. Payments under the scheme will be suspended if at any time the practice is unable to provide services in line with the service specification or fail to meet contractor eligibility criteria. Before any suspension the practice and Camden CCG will meet discuss the reason for the suspension identifying any possible resolution. If the matter is not resolved the CCG will issue a suspension notice to the practice within seven days. 7.7. Either party can appeal against a suspension or termination notice to the CCG s Director of Operations. 7.8. A provider s involvement in the LES will be suspended if at any time the primary care provider is unable to provide services in line with the eligibility criteria. 7.9. Before any suspension the primary care provider, the Lead Clinician for Anticoagulation at the Royal Free Hospital, the CCG Director of Quality & Safety, and the CCG Governing Body Lead GP for Primary Care will discuss the reasons for the suspension, identifying any possible resolution. 7.10. If the matter is not resolved, the CCG will issue a suspension notice within 7 days to the service provider, which must cooperate in the transfer of existing patients to an alternative primary care provider or back to secondary care as deemed clinically appropriate upon discussion with the Lead Clinician for Anticoagulation at the Royal Free Hospital. 7.11. The scheme shall be suspended immediately if the CCG Director of Quality & Safety or the CCG Governing Body Lead GP for Primary Care deems patient safety to be compromised by its continuation. 7.12. If the service is suspended, or subsequently dissolved, the CCG reserves the right to transfer relevant clinical records. 7.13. Payments to primary care providers will be suspended immediately upon notice by the CCG being issued. 8. Useful information 8.1. Contacts for routine clinical queries Clinicians should contact the named clinical lead for anticoagulation in their own organisation in the first instance. Urgent clinical advice will be provided to GP practices by the anticoagulation team for queries between 11:00 and 12:00 Monday to Friday. The team can be contacted by telephone on 020 3758 2018Non-urgent clinical advice can be sent by email to rf.acc@nhs.net. Emails will be responded within two working days of receipt by one of the Anticoagulation Clinical Nurse Specialists In a medical emergency, for example major bleeding, patients should be sent directly to A&E. Universal Offer: Anticoagulation Warfarin Spec 2017-2019 v1 10

8.2. Urgent clinical or out of hours (17:00-09:00) advice can be sought via the Haemophilia Registrar who can be contacted on their mobile via the Royal Free Hospital Switchboard on 020 7794 0500. Consultant advice can also be obtained via the Switchboard. Contractual Queries about the service specification should be addressed to: Camden CCG Email: camdenlcs@nhs.net Universal Offer: Anticoagulation Warfarin Spec 2017-2019 v1 11