SCHEDULE 2 THE SERVICES

Transcription

1 SCHEDULE 2 THE SERVICES A. Service Specifications 1 Introduction Anticoagulants are medicines which slow down the blood clotting process and are used to support the prevention of clot development. They are used for a number of different clinical conditions including; Atrial Fibrillation to reduce the risks from strokes. Patients with AF have a five-fold risk of stroke and AF strokes are often more severe with higher mortality and greater disability. 1 P a g e Venous Thromboembolic Disorders Prophylaxis and treatment of thromboembolic complications associated with cardiac valve replacement. Initiation of anticoagulation is important as the clinician needs to ensure the patient fully understands the different treatment options. Treatment choice must be based on clinical features and patient preference. Anticoagulation may include the Novel Oral Anticoagulants (NOACs) e.g. apixaban, dabigatran etexilate, edoxaban or rivaroxaban) or Vitamin K Antagonists (VKAs) e.g. acenocoumarol, phenindione and warfarin. Warfarin is the most commonly prescribed of the VKAs. Regular blood monitoring of patients on warfarin is necessary, as although it is very effective it can also have serious side effects, e.g. severe haemorrhage. Monitoring measures the International Normalised Ratio (INR) level, which measures the delay in the clotting of the blood caused by warfarin. While the normal INR is 1, the specific range of INR values depends on the disease and the clinical conditions being treated. Warfarin initiation and monitoring aims to ensure that patient INR levels are stabilised within set limits to help prevent serious side effects while maximising effective treatment. NOAC s are not licensed for all the same indications as warfarin. Although they do not require routine blood monitoring they can still have severe side effects so it is very important for the patient to get the appropriate NOAC at the appropriate dose. This service will be able to initiate NOACs and then on going care will be passed back to the GP practice. All patients on anticoagulants must have an annual review; this service will undertake the review for any patients on warfarin and the GP practice should undertake annual reviews for patients on NOACs.

2 The primary care INR monitoring service is well established in City & Hackney, this specification builds on the existing service with the following changes: The service is to be accessible to all suitable patients registered with a GP in City & Hackney (irrespective of whether the patient is registered with a GP practice that provides the primary care anticoagulation service) This is an anticoagulation service which includes initiation of the most appropriate anticoagulant as well as ongoing monitoring for any patients receiving warfarin. Complex patients will remain in secondary care. The primary care service will be actively pulling patients out from secondary care so as to maximise usage of this accessible, cost effective primary care service. The contract holder will be the GP confederation who will be providing overall management and co-ordination of the service. Improving rates of anticoagulation in patients with AF is a priority for all CCGs so as to reduce the morbidity and mortality from strokes. There will be an increasing number of patients with AF requiring anticoagulation due to: Improvements in the diagnosis of AF. The national prevalence is 1.8%, the latest QOF data gives an overall City & Hackney prevalence of 0.7% In a medicines management audit which will be undertaken in all practices which aims to identify and review all AF patients currently exception reported for anticoagulation to ensure we only have genuine, current exceptions. The same audit will also identify any AF patients who are being treated with an antiplatelet medicine which is not a recommended treatment option. Please note that there is a need to differentiate between the GMS service and the primary care anticoagulation service. In this specification, reference to GP refers to GMS and the service provider is the primary care anticoagulation service. 2 Outcomes Of the NHS Outcomes Framework the following will be supported through this contract. 1 Preventing people from dying prematurely 2 Enhancing quality of life for people with Long term conditions 3 Helping people recover from episodes of ill health or following injury 4 Ensuring people have a positive experience of care 5 Treating and caring for people in safe environment and protecting them from avoidable harm 2 P a g e

3 The aims of the service are to provide a high quality, comprehensive community based anticoagulant service which will serve patients aged 16 and over, who are registered with a GP within City and Hackney and to: Provide anticoagulant POC (point of care), face to face blood monitoring service with on-going short and long term management of patients on warfarin to ensure INR levels remain therapeutic. Provide a community based face to face counselling and initiation of oral anticoagulant therapy service for patients with atrial fibrillation and meeting service criteria. Provide a domiciliary service to those patients who are housebound or in care/nursing homes. Provide patient education to support the improvement, understanding and long term outcomes of patients on oral anticoagulants. Maintain a robust communication network between all medical and allied health professionals involved in individual patient s care. Actively draw patients who are receiving anticoagulation monitoring from secondary care into the community enabling the Haematology Department to focus on unstable and more complex cases. Provide services that are near to patients and easily accessible both in terms of location and opening times. Provide rapid access to anticoagulant initiation with the target being a maximum of seven days between referral and treatment starting. Comply with appropriate and most recent national and local guidelines including those from: British Society of Haematology (BSH) guidelines (previously known as BCSH Guidelines) NICE guidance National patient safety agency(npsa) Ensure a consistent approach to testing, sampling and dosing across provider sites within the primary care service and between primary and secondary services. Ensure the maintenance of patients is properly controlled with at least an annual review of anticoagulation with the patient where all current options are discussed. Objectives of the service are: Anticoagulant services should be offered in a one stop clinic offering patient education, discussions, blood tests and drug/dose changes in the same consultation. Patients should be offered access to all anticoagulant options in line with licensed indications. Anticoagulation services must be accessible in terms of location and opening times. To reduce delays in treatment initiation. The target for initiating anticoagulation treatment is one week from referral. The service overall and each provider site must have a clinical lead who has overall responsibility for the anticoagulation service. To provide a safe effective service with full Service Operating Protocols (SOPs) and Quality Control systems. (QC) All patients receiving a Vitamin K antagonist must be given a yellow oral anticoagulant information pack including a dosing book and alert card. All patients receiving a NOAC must be given the relevant drug information pack including an alert card. To support patients in understanding and managing their anticoagulant treatments providing comprehensive and on-going education so that they better understand their therapy To obtain feedback from patients and then use this to improve anticoagulant services. 3 P a g e

4 All patients must receive at least an annual review of their anticoagulation treatment where all options are discussed. The service must be provided by trained and competent staff working within the limits of their competency, role and professional boundaries. To ensure appropriate communication about anticoagulation across all relevant boundaries and in particular with the patient s GP (if the service provider is different) and the appropriate secondary care anticoagulation service if needed. To ensure complete and accurate documentation of clinical protocols and individual patient records. This involves working with the Computerised Decision Support System (CDSS) which currently is INRStar and any GP clinical record systems such as EMIS. To regularly (and at a minimum of every quarter) review practice prescribing records for all patients receiving warfarin prescriptions and identify any patients not currently being monitored in primary care. Unless patients are coded as having any of the primary care service exclusion conditions as listed in section 3.2 then a letter as shown in Appendix One must be sent to the appropriate secondary care anticoagulation department requesting for care to be transferred back to the primary care service. Suitable patients should be offered the opportunity to self-monitor or self-manage their Vitamin K antagonist. (see section ) Any patients newly initiated on anticoagulation should be referred to the community pharmacy of their choice for the New Medicine Service which provides adherence support. To provide data on Service delivery, including patient numbers, domiciliary visits, referral to treatment times, clinic waiting times etc. Quality and safety Patient satisfaction and patient experience survey 4 P a g e

5 3 Scope of Service Patients will be referred to the service from general practice and secondary care, this will include patients whose anticoagulant therapy has been previously initiated and managed by acute services. This specification requires the provider to deliver: A validated programme of initiation and counselling of oral anticoagulants therapy, this will include patient choice. An anticoagulation monitoring service for patients on warfarin that is in line with validated service protocols 3.1 Summary of responsibilities The anticoagulation provider will be responsible for ensuring that the service is provided according to the service specification. In particular, that: Dose recommendations and recall are made according to approved guidelines; Patient education regarding anticoagulation therapy is provided and the patient hand-held record is kept up-to-date; Each patient s anticoagulation therapy is reviewed at least annually; Patients are referred to A&E or secondary care where required; The Provider complies with the 2015 NHS Serious Incident Framework and the Never Events Policy Framework, and must report all Serious Incidents and Never Events in accordance with the requirements of those Frameworks; All elements of the specification are followed; Staff running clinics are all appropriately trained and competent. These staff should on average be managing the INR monitoring for a minimum of 15 patients receiving warfarin. The clinic is run in line with all appropriate Quality Control processes (see sections 4 & 6.2) 3.2 Target Population and Eligibility Criteria All patients within City and Hackney who require anticoagulation monitoring and who fit the criteria below will be eligible for the primary care anticoagulation service. This includes patients requiring domiciliary visits. Patients can access the service by: o Referral from their GP o Referral from secondary care o The service proactively contacting secondary care to pull patients out into the service as detailed below The majority of patients requiring INR monitoring can be managed in primary care so the assumption should be that all stable patients should be discharged back to primary care as soon as possible. The service provider may consider that there are some patients that would be better managed by secondary care; if there is any uncertainty then there needs to be a discussion between the lead clinician for the provider site and the consultant haematologist. 5 P a g e

6 There are few clinical conditions that are absolute contraindications for having their INR monitored by this primary care service. However patients in the following categories may be more challenging to manage and some may need to remain in secondary care, decisions will be made on an individual patient basis. Patients in these categories that are stable and discharged to primary care will have information about any special arrangements included in their discharge summary. A known hereditary or acquired bleeding disorder. A known hereditary or acquired thrombophilia. Has had a DVT/PE in previous month; these could be discharged to primary care after one month. Liver failure; if liver function is deteriorating then these patients should either be kept by secondary care or if already in primary care considered for referral back to the specialist service. Documented evidence of CNS haemorrhage in the previous 6 months; Gastro-intestinal bleeding in the previous 6 months; Patients receiving a Vitamin K antagonist ( e.g. phenindione or acenocoumarol) A known alcohol problem IV drug user On chemotherapy Children under 16 years of age will all be managed in specialist clinics. Pregnant women will also be managed by secondary care services. ` 3.3 Primary Care Clinic Arrangements The overall service and individual sites will need to name an individual as the clinical lead who will be responsible for ensuring that the service is delivered in accordance with the specification. All patients will be seen in person either in a clinic or at home by a member of staff who has undergone appropriate anticoagulation training. Initiation and any change of dosing must always be undertaken by a health care professional employed by a clinic; this can either be a pharmacist, practice nurse or GP. Health care assistants may run the anticoagulation clinics for stable patients but there must always be an experienced health care professional available to deal with queries. The health care assistant must always work within the recommendations of INRStar and under no circumstances can they override the recommendations of the system.(experienced registered health care professionals e.g. nurses, pharmacists or GPs may override INRStar recommendations) Provider sites will be expected to run anticoagulation clinics at a minimum of once a week with provision to review patients ad hoc to ensure safety e.g. if a patient becomes unwell or needs to take new medication that may affect their INR The length of time between test dates will vary but patients should have their INR checked at least every 12 weeks. Less stable and new patients will require more frequent tests. Patients who are self-testing/self-monitoring should be seen in clinic at least annually, see section The provider should ensure that a systematic call and recall system is in place and should be able to provide data to demonstrate the effectiveness of the system. o Under normal circumstances a patient who fails to attend a clinic at an agreed time should be contacted by telephone and then standard letter if needed. o The provider should implement appropriate and effective strategies for 6 P a g e

7 monitoring and targeting non-attenders. The provider is clinically responsible for all patients under their care for anticoagulation monitoring and should ensure that explicit contingency plans are in place to cover periods of absence for annual or sickness leave both for the running of clinics and for advice to patients who have queries or problems. The provider will be expected to review and reassess anticoagulation control of all patients prescribed warfarin and discuss the risks and benefits of anticoagulation strategies in line with current national and local guidelines. Each provider site must have in place Standard Operating Procedures (SOPs). The SOPs must cover all features of the service and although they can be standardised across all provider sites they must also be specific to the provider site if there are conditions that invalidate the standard SOP. The service must ensure that SOPs are updated as necessary and reviewed at least every two years. 3.4 Clinical Management Initiation When patients (and/or their carers) arrive for their first appointment for anticoagulation initiation for Atrial Fibrillation (AF) there must be a full discussion about the risks and benefits of anticoagulation with a particular focus on the stroke risks. Referral information should include the CHA2DS2-VASc and the HAS-BLED scores. The HAS-BLED tool should not be used to exclude people from anticoagulation, but rather to identify risk factors that can be modified in order to lower the risk of bleeding. All anticoagulation options should be discussed with the patient and the treatment decision made based on clinical features of the different agents and patient preference. Factors to consider include: Patient factors including: Extreme age, extreme weight, unstable diet, adherence, need for MDS, ability to attend clinic, Women of CBA will need contraceptive advice, adherence with complex regimens, allergies and other concerns from the patient. Medication and drug dosing including: Current medication (interactions), renal function liver function, Lack of licensed antidotes for NOAC Disease factors including Risk of intracranial haemorrhage, previous bleeds. Risk /benefit assessments (CHA2DS2vasc and HASBLED scores), other co-morbidities, mitral stenosis or mechanical heart valve and blood pressure control. Some key resources to support initiation include; Shared decision making with the patient on starting an anticoagulant and choice of anticoagulant (share NICE decision aid with patient) NOAC checklist, please see NCL DOAC counselling checklist for information. NOAC information sources, the CCG is developing local resources but extensive information is available from (15) & (16) The appropriate alert card If the choice is warfarin, the service will continue to monitor the INR according to the specification. If the choice is for a NOAC then there should be one short follow up appointment to ensure there are no problems, to check adherence and to reinforce supply systems. If the patient is not a registered patient at the practice that is linked to the anticoagulation clinic, they should be discharged to their usual GP for ongoing review and prescribing. A full review of anticoagulation should be part of the annual AF 7 P a g e

8 review. Key information for patients includes Name of drug and current dose Anticipated length of treatment; What to do in the event of a missed dose; Importance of adherence Symptoms of under and overdose and what to do if these occur; Drug and food interactions; What to do if dental treatment or surgery is required; useful information is available from the Scottish Dental Clinical Effectiveness Programme (17) Contact details for the provider in case of concerns; Target INR, latest INR result date and time of last appointment ( if on warfarin ) Patient Education Although patient education is a critical part of the initiation of anticoagulation there is an opportunity for ongoing education at each appointment. In particular the service provider must ensure on an ongoing basis that the patient understands: Name of drug and current dose; Reason for and objectives of treatment; Anticipated length of treatment; What to do in the event of a missed dose; Importance of adherence Symptoms of under and overdose and what to do if these occur; Drug and food interactions; What to do if dental treatment or surgery is required; Contact details for the provider in case of concerns; Target INR, latest INR result, date and time of next appointment ( if on warfarin ) Hand-held records Each patient receiving a vitamin K antagonist will have an individual hand-held record or yellow book in which INR levels, dosing information, date of next test and contact numbers for advice are recorded at each visit. Patients should take the record book with them to each consultation with health care professionals in primary, secondary and tertiary care. Record keeping in the hand held record should be maintained by the Primary Care Service. Patients should be frequently reminded to carry their yellow book with them at all times and to show it to any health professional whenever they seek treatment or advice. Electronic copies of the Oral Anticoagulation Therapy patient information booklets are available in English and a range of languages at: All patients receiving a NOAC must be given the relevant drug information pack, including an alert card Record Keeping Anticoagulation providers will keep a record for each patient that will be updated at each clinic visit and will include: Patient s INR; 8 P a g e

9 Dose of anticoagulant; Date of next appointment; Information from the patient about unusual bleeding or bruising, adherence to treatment, other medication, changes in diet or planned surgery; Information from current prescriber (where appropriate); Additional information from the patient s medical notes (where appropriate) Other data required In addition, the provider should be able to provide the following for any patient under their care: Patient name, DOB and address; Indication for anticoagulation treatment; Planned length of treatment and discontinuation date; Target INR and desirable therapeutic range; Time in therapeutic range (TTR); Relevant notes supporting dose decision, counselling advice, self-testing or selfmanagement and ongoing clinical review; Frequency of missed appointments; Medical conditions, hospital admissions likely to affect anticoagulation such as increased risk from haemorrhage; Bleeding episodes and adverse events; Name of initiating Consultant or GP; Any actions taken other than dosing and retest dates. The computerised decision support software used by the provider will be set up to store most of the above information. Otherwise the relevant information will be available from the patient s medical notes which must be accessible. Where patients are being seen by a provider site that is not their registered GP practice it is the responsibility of the provider to ensure they have access to any required information using EMIS clinical. The provider is required to ensure that all clinical information relating to the anticoagulation service is recorded in the patient s own GP held lifelong record Prescribing of anticoagulants For prescribing information (including contraindications, cautions and drug interactions) please refer to the BNF or other appropriate evidence based resources. The prescribing of all anticoagulants will remain the responsibility of the patient s GP regardless of where the initiation or INR monitoring is undertaken Dosage of warfarin should be calculated using Computerised Decision Support Software or approved clinical guidelines. The anticipated duration of overall treatment will be documented at the point of the initial referral. The risk versus benefit of continual treatment should be reviewed regularly and at least annually. Responsibility for the decision to discontinue warfarin must reside with the patient s GP, but the anticoagulation monitoring provider should raise any concerns as appropriate. Warfarin will be discontinued on an agreed defined date, clearly documented and all people involved in the patient s care informed. Where there is uncertainty about risks and benefits of continued 9 P a g e

10 treatment, contact the Haematology department at Homerton Hospital for further advice Individual Annual Review All patients receiving anticoagulation must receive an annual review of their treatment with a healthcare professional. This review should include: Review of the indication for anticoagulation Assessment and correction of bleeding risk factors (e.g. by using HAS-BLED) Patient education, information and decision support Assessment of medication adherence Review of alternative anticoagulant strategies For patients on warfarin, assessment and documentation of INR and assessment of INRs that fall outside of the therapeutic range ( especially INRs < 1.5 and > 5 ) For patients on NOACs, renal +/- renal function as indicated. Medicines optimisation (including ensuring that anti-platelets are not concomitantly prescribed unless there is a definite reason as recommended by a named specialist ) This review should ideally be undertaken by the anticoagulation service but could also be undertaken by the GP practice. The anticoagulation service should keep records of annual reviews for all patients under their ongoing care. For patients on NOACs that have been transferred back to primary care, it is assumed that the GP practice will carry out this review Management of Bleeding/Over Anticoagulation See Appendix Four for further information on managing patients with a high INR. In addition patients should be referred to the A&E Department if they have: Signs or symptoms of major bleeding or of thromboembolism; Thought to be at risk of major bleeding or thromboembolism. The risk of haemorrhage increases significantly when the INR is > 5.0. All patients with bleeding should be evaluated by the INR monitoring provider to determine whether there is a local anatomical cause for the haemorrhage. Patients must be referred to the Haematology Department if the anticoagulation provider feels that the management of a specific patient is outside his/her sphere of competence Domiciliary service Primary care providers agree to monitor all patients deemed suitable for primary care monitoring, including those with mobility problems who are unable to travel to the practice without assistance. For patients with mobility problems, the sites can either decide to conduct home visits or, if appropriate, organise for the patient to travel to/from the clinic by taxi. For both options the service will be considered to be a domiciliary service and eligible for the higher specific charge for a domiciliary visit but auditable records should be kept. Taxi reimbursement costs are already included in the payment for domiciliary visits Post-operative patients Patients who require surgery may need to have their warfarin stopped temporarily. In all cases, the provider should follow the agreed local protocol or should contact the Haematology Department for advice if needed for any particular patients. 10 P a g e

11 Adverse Events The Provider must comply with the 2015 NHS Serious Incident Framework and the Never Events Policy Framework, and must report all Serious Incidents and Never Events in accordance with the requirements of those Frameworks. The Provider is expected to report all Serious Incidents to the Commissioner. These include: Any patient who has a major bleed or thrombosis; Any apparent drug reaction or interaction; Death of a patient on anticoagulation therapy whatever the cause Self-management and self-monitoring arrangements The provider should ensure that there are suitable systems in place for patients who wish to self-monitor or self-manage their INR in line with national guidance recognizing that these are very different systems. These could be a particularly useful option for patients on long term INR monitoring who are not suitable for a NOAC. There is evidence that patients on self-monitoring or self-management compared to standard monitoring show improved quality of their oral anticoagulation therapy. The provider is also encouraged to consider any technology that might support patients undertaking self-monitoring. A full Standard Operating Procedure (SOP) must be in place to cover: Training and competency assessment of any patients undertaking self-testing or self - monitoring Appropriate external quality assurance for any machines used by patients An agreement should be signed by the patient and the healthcare professional clinically responsible for the anticoagulation service and this should include: review of the patient at least every 6 months for the first 12 months and then annually thereafter, and documentation of results and dosing Use of appropriate machines that have been evaluated for self-monitoring. Once patients have demonstrated compliance with self-monitoring then it would be possible to move to self- management where patients decide the appropriate dose. Again a full SOP must be in place. Currently there is no specific funding for self- monitoring or self-care. We understand that current expenditure is picked up by patients purchasing machines and GP practices prescribing the appropriate strips. The provider will still be funded the usual fees for any self-monitoring patients and will be expected to provide activity data for this patient group. However the overall funding situation needs to be kept under review. 4 Quality & safety systems 4.1 Near Patient Testing (NPT) and Quality Control (QC) The NPT equipment must be properly maintained and calibrated, and a record of patient identity, date and time of testing, test strip lot number, and operator must be kept to create an audit trail. 4.2 Internal Quality Control (IQC): Providers must undertake appropriate internal quality control activities in line with the 11 P a g e

12 manufacturer recommendations (Roche Diagnostics). 4.3 External Quality Control (EQC): Providers must undertake appropriate external quality control of the near patient testing (NPT) equipment. WEQAS is a UKAS (United Kingdom Accreditation Service) accredited proficiency testing provider, used to monitor the performance of anticoagulation machines. Practices are required to submit their quality control results to WEQAS every two months within the timescales stipulated by WEQAS in line with their process for submissions. Practices must have systems in place to anticipate the receipt of WEQAS samples which must be tested and the results then returned to WEQAS within the required time limit. End of cycle WEQAS results MUST be documented in INRStar N3. WEQAS Point of Care Team contact details: Weqas.Poct@wales.nhs.uk; Telephone number: / Computerised Decision Support Software (CDSS) Computerised Decision Support Software (CDSS) will provide guidance on dosing as well as record patient details and outcomes. The software will enable providers to develop and maintain an up-to date register of patients which will include patient name, date of birth, the indication for, and length of, anticoagulation treatment, including target INR. Practices will use the web-based version of INRStar. GPs whose patients are being monitored by other practices will also be able to access their own patient s data via the online INRstar. 4.5 Clinical Audit The provider must undertake an annual audit of the overall service involving all provider sites covering the quality requirements as outlined in Section Applicable national standards (e.g. NICE) The applicable national standards for this service are: British Committee for Standards in Haematology (1998, updated 2011) Guidelines on oral anticoagulation: Third Edition. British Journal of Haematology, 101, British Committee for Standards in Haematology(2014) Guidance on Patients self-testing and self-management of oral anticoagulation with vitamin k antagonists National Patient Safety Agency (2007). Patient Safety Alert 18 Actions that can make anticoagulant therapy safer to be found at: http // NICE Clinical Guideline 180 The Management of Atrial Fibrillation(2014) NICE Clinical Guideline 144 Venous thromboembolic Diseases(2012) NICE Quality Standard 29 Venous Thromboembolic Diseases(2013) NICE Quality Standard 15 Patient experience in adult NHS services(2012) NICE Diagnostic Guidance 14 Atrial Fibrillation & Heart Valve Disease: Self monitoring coagulation Status Point-of-Care Coagulometers (2014) NHS England, Patient Safety Alert, to improve reporting and learning of medication and medical devices incidents. Commissioning guide: Commissioning excellence in anticoagulant care for (Dec 2016) London Clinical Networks 12 P a g e

13 The provider will note that the clinical management of patients outlined in this specification may be subject to changes in line with new and emerging national guidance and standards. 4.7 Applicable local standards The provider will be responsible for the development and update of Service Operating Protocols (SOPs) for all elements of this service. All SOPs should be in place prior to service commencement and be signed by the overall service clinical lead. SOPs can be standardised across all provider sites but they must also be specific to the provider site if there are conditions that invalidate the standard SOP. The service must ensure that SOPs are updated as necessary and reviewed at least every two years. The list of SOPs should include but not be exclusive of: Counselling and commencing of oral anticoagulants for atrial fibrillation (to include warfarin and NOAC s) this must always be in line with the City & Hackney- HUHFT joint formulary Point of Care devices Guideline for use of CDSS including staff training and access Staff training and clinical supervision Testing procedure finger prick/sample testing Compliance with external quality assurance systems, currently that is WEQAS Dosing guidance and standard management ranges Maximum recall periods during maintenance therapy Situations where warfarin may need to be stopped or the dose amended e.g. surgery or dental treatment. Management of INR outside the therapeutic range, to include: o Questions to be asked when INR falls out of range o Dosing protocols for out of range INRs o Conditions which may cause a change in INR. Domiciliary service provision to include a lone worker policy INR Self-testing/self-management policy Drug and food interactions and co-prescribing with warfarin Communications process between other service providers and professional groups including the patient s GP. Of particular importance is to have a clear, safe process for communication between the provider clinic and the patient s GP practice if they are not one and the same. Management of adverse events Patient counselling and education Management of patients who fail to attend appointments, this should include a number of follow ups including both telephone calls and a letter. If the patient still fails to attend he patient s GP must be informed within 7 days of the missed appointment Consumables (Coaguchek test strips, lancets and internal QC test controls) are ordered by the provider sites currently from Roche Diagnostics Customer Services (Telephone: ) Sites must not over order as expiry dates for consumables are short. WEQAS registration and INRStar licences and supplies of consumables will be paid for by the provider. 5 Location and standards of provider premises Clinics shall be provided in the community and geographically spread in line with population need and within accessible locations. Patients should be able to access a minimum of one early 13 P a g e

14 clinic starting at 8am and one late clinic closing no earlier than 6.30 pm each week in a location that is reasonably easy to access. Suitability of premises for anticoagulant monitoring should be reviewed initially and then on an annual basis. The following criteria must be met: The consulting room must be private and large enough for all necessary equipment, with the patient and service provider to sit down together and talk at normal speaking volumes without being overheard. The consulting room must be fitted with the following: Sink with hot and cold running water Wipe Down Surfaces Flooring non-slip blood spillage compliant Electrical power points and wiring for computer and internet access Computer terminal (or laptop) and lockable filing system. Telephone access Suitable lighting, desk and seating Access to an NHS.NET address Access to CDSS system via N3 connection The premises must be maintained in a clean and tidy condition. There must be a fridge within the premises that meets laboratory storage standards. There must be sufficient seating for patients whilst they are waiting to be seen at the clinic Disabled/Wheelchair access in waiting area and consulting room The service provider will be responsible for the financial provision of: All near patient testing POC machines and consumables e.g. test strips. Machines must be within warranty and comply with medical devices legislation. Continued maintenance and replacement of POC machinery Registration with an external quality control system; currently WEQAS is used. All other POC consumables (including single use lancets and personal protective equipment). Access to CDSS, currently INRstar is used. Annual licences must be purchased Computers with access to colour printer at all sites of delivery Clinical waste disposal Oral anticoagulant therapy information packs and patient alert cards. The provider will need to show evidence of a strategy for covering anticoagulant clinics and urgent tests in the event of any staff absence including sickness, annual, and study leave. The provider will be given a 36,000 budget (per annum) to fund Coaguchek strips. At the end of the financial year the provider will undertake a reconciliation that will either identify an underspend against the 36K, which could be returned to the CCG or reinvested in the service, or identify an overspend. In the first year of this arrangement the CCG will hold 100% of the risk for overspends within the financial year. For 2019/20 we would like to share the risk of any overspend on a 50/50 basis with the Confederation but also move to an arrangement where it is assumed that 50% of the underspends is reinvested in the service at year end. WEQAS annual fee INRStar annual fee Machine replacement costs if there are no existing machines that can be used as an alternative and the provider was not at fault for any damage to the machine Training costs upto a maximum of ten new staff per annum and upto a maximum of 1000 in total for locally provided annual update training 6 Data requirements 14 P a g e

15 6.1 Performance data The provider will be required to submit performance activity reports for the whole service and for each clinic on a quarterly basis giving details of: Total number of patients monitored on warfarin split into those monitored by a provider clinic sited in their own GP practice and those registered in other GP practices. Number of New Referrals that commenced warfarin for atrial fibrillation in the last quarter Number of New Referrals that commenced NOACs for atrial fibrillation in the last quarter Number of New Referrals already commenced on warfarin i.e. transfers from secondary care Number of attempts and number of patients where transfer of patients from secondary care into the primary care service failed with reasons why. Number of patients receiving domiciliary visits Results from WEQAS service Point prevalence results for the overall monitoring service and for each clinic. The point prevalence shows the percentage of patients whose last INR result falls within +/- 0.5 units of their target INR. The requirement in the contract is that the point prevalence figure should be at least 60% for each clinic. The composite performance reports 6.2 Key performance indicators The provider will be required to provide data to the commissioner as part of an audit process in relation to the contractual compliance of the service. The data must be provided for each clinic site in addition to the composite for the whole service. The minimum data required is: Quality Outcomes Key Performance Indicators Indicator Frequency Threshold From referral to first appointment (Percentage seen within one week?) Quarterly Year one Within one week 80% by 30/9/18 Number of Referrals delayed by incomplete referral data Number of Patients referred back to secondary care for on-going INR monitoring together with reason Number of patients where primary care has requested transfer back to primary care The minimum number of patients expected to be discharged from the secondary care service is 58 per quarter Quarterly Quarterly Quarterly Year two Within one week 95% by 30/9/19 For review For review and action if numbers are low. Depending on reasons this could incur a penalty on the project manager fee. Number of patients self-testing Annual For review and action Proportion of patient-time in range. Quarterly In line with NPSA 15 P a g e

16 standards of safety Percentage of INRs >5.0. Quarterly In line with NPSA standards of safety Percentage of INRs >8.0. Quarterly In line with NPSA standards of safety Percentage of INRs >1.0 INR unit Quarterly In line with NPSA below/above target Internal and external quality control records e.g. sample checks & WEQAS results Number of adverse events including major bleeds. Incident analysis and details of any preventative action taken must be anonymised and submitted. Number of complaints received in relation to service Patient experience patient satisfaction surveys to include: Anticoagulation counselling at initiation INR monitoring service o Clinic attendees o Domiciliary Service Quarterly Immediate if SUI and Quarterly Quarterly Annual standards of safety WEQAS sampling must be undertaken bimonthly For investigation and review at the time Survey to be completed and any resulting action plan is completed Number and percentage of patients lost to follow up exceeded DNA limit List of SOPs currently in place and date of last review Staff competency, qualifications, training, relevant on-going training and assessment dates Confirmation of location and access times of the current provider sites Quarterly Annual Annual Annual In line with NPSA standards of safety SOPs to be in place Training records upto date 16 P a g e

17 Appendices Appendix One Appendix Two Appendix Three Appendix Four Appendix Five Appendix Six Request for Discharge of Patient from Secondary to Primary Care for INR Monitoring Example letter that can be used to advise patients of the change in anticoagulation provider Training & competency assessment requirements Patients Prescribed Warfarin: Suggested process for dealing with high INRs with no bleeding or major bruising Flowchart for anticoagulation in patients with AF References 17 P a g e

18 Appendix One - Request for Discharge of Patient from Secondary to Primary Care for INR Monitoring Add name of Surgery / address / telephone / fax To: Consultant Haematologist DATE: Homerton University Hospital Haematology Department Homerton Row, London E9 6SR Dear Dr Request for Patient Discharge to Attend INR Monitoring at the Surgery The patient below is under your care for INR monitoring and in line with the agreed commissioning arrangements needs to be considered for discharge back to primary care. There currently is a comprehensive primary care anticoagulation service that covers patients registered with all GP practices in City & Hackney. Please provide our service with all the relevant information from your clinical decision support software (CDSS) to facilitate their discharge from your service. If you consider the patient is not currently suitable for a transfer to the primary care anticoagulation service please supply the reasons why so we can record this in the patient s primary care clinical record. The details of this patient are: First name / surname D.O.B. ADDRESS / Tel. No. NHS No Thank you for your support in this matter and kind regards, 18 P a g e

19 Appendix Two Example letter to be sent to patients that need to move from secondary to primary care Dear Patient Re: Change to anticoagulation clinic arrangements In City & Hackney we still have many patients taking warfarin who are travelling to hospital for INR monitoring. Most patients do not actually need this service to be provided by a hospital, and moving it to a place closer to the patient s home would allow the hospital to concentrate on more complex patients. There is a primary care service that has been safely monitoring INR levels for over 600 patients on warfarin for the past nine years and which has been provided from multiple sites across City & Hackney in line with national quality standards. (1) It is important for health services to be provided as cost effectively, and as close to where patients live, as possible. NHS City and Hackney Clinical Commissioning (CCG) are therefore currently increasing the number of patients, who can be monitored locally, You are currently attending the hospital for your monitoring, but in future this will be done at: (Please delete as applicable) 1. Your GP practice: please contact your usual GP surgery and make an appointment for the anticoagulation clinic. 2. The local primary care anticoagulation service: please phone the number below to make an appointment for the anticoagulation clinic. Name of anticoagulation lead Clinic address Clinic phone number If you have any queries about this change please do contact the new clinic; they, or your GP practice if you prefer, will be happy to deal with them or any concerns you may have. Yours sincerely (1) Support for commissioning: anticoagulation therapy 19 P a g e

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21 Appendix Three - Training & Competency assessment requirements The provider is able to specify their own training and competency assessment programme but it must be at least as rigorous as the one proposed below. It is the responsibility of the overall service provider clinical lead to ensure that the training and assessment of competency is fit for purpose and as a minimum meets this specification. They also have responsibility of ensuring that any staff assessing competency are themselves fit to undertake this role. As part of the accreditation process the clinical lead and all provider staff who will be involved in near patient testing and/or dosing will be expected to attend initial training. A half day refresher training should be undertaken on an annual basis for provider sites that have been running the service for more than 12 months. Funding for no more than ten people to attend initial anticoagulation training each year will be available from the CCG The initial training will consist of 1. Successful completion of a theoretical anticoagulation course such as the one provided by King's Thrombosis Centre, Department of Haematological Medicine, 4th Floor Hambledon Wing West, King's College Hospital, Denmark Hill, and London SE5 9RS. 2. Training and completion of competence in the use of near patient testing coagulometer which currently is CoaguChek Pro ll used in most sites (Practical training) 3. Use of the IT computerised decision support software (CDSS) 4. Evidence of clinical supervision Annual refresher training will be needed for all staff both directly running clinics and providing back up clinical advice. Assessment of practical competence does not need to be regularly repeated but should be considered if there are indicators of a problem such as: low point prevalence, failed WEQAS tests. All staff will need to supply supporting evidence of having met individual clinical and governance requirements in: Dealing with blood products and spillage Health and Safety including legislation Hand washing and infection control Needle stick injury Data protection Staff Disclosure and Barring Service (DBS) clearance (previously known as Criminal Record Bureau (CRB) clearance). 21 P a g e

22 Managing dosing of anticoagulant therapy can only be undertaken by qualified health care professionals that are currently registered with GMC, GPhC or the NMC (RN adult) and who must maintain their continuous professional development (CPD). Practitioners will be expected to maintain and develop their specialist skills and knowledge. As part of performance monitoring, they will need to produce evidence relating to: Relevant CPD Quality improvements in response to audit/clinical governance information Quality improvements in response to patient satisfaction survey Attendance at study/training days or completion of on-line modules. The practical aspects of the training will involve providing and demonstrating the following competencies: Competency The ability to take capillary blood samples demonstrating good finger-prick technique Method of assessment Demonstration of good finger-prick technique in taking samples from 8 patients. Achievement of the desired standard in a formal assessment. The ability to use the current coagulometer (CoaguChek Pro ll is the machine currently used in most sites) Demonstration of competency by testing the INR of 8 patients. The result should match an INR test done by an existing experienced member of staff Achievement of the desired standard in a formal assessment. The ability to use the computerised decision support software. Achievement of the desired standard in a formal assessment of at least eight patients. 22 P a g e

23 Appendix Four Suggested process for dealing with high INRs with no bleeding or major bruising INR > 4.5 (Unless the INR is in the target range for that patient) Repeat test using new test strip Result within 0.5 of first test Result more than a 0.5 difference to first test INR confirmed between and no bleeding Stop warfarin for 2-4 days or as recommended by CDSS, repeat INR When INR within 0.5 of target, restart warfarin, review possible causes of high INR, consider using lower dose Oral Phytomenadione not normally needed unless there is a high risk of bleeding Inform patient s own GP if appropriate and advise on next steps INR confirmed as > 8 and no bleeding or major bruising *Send venous sample to lab marked urgent Stop warfarin Contact Anticoagulation Consultant Haematologist/registrar for advice or follow guidance in the box below Disregard result and *send venous sample to laboratory for analysis; perform IQC on POCT device. Consider stopping warfarin until a reliable test result is obtained then treat the patient * Venous sampling is undertaken to confirm INR of more than 8 and should not be used for dosing N.B. All INR results from capillary and venous sampling must be entered onto Computer Decision Support Software (CDSS) 23 P a g e If confirmed INR > 8 but < 10, consider giving vitamin K 1mg orally. If INR > 10 give Vit K 2mg orally. Vitamin K to be prescribed as IV Injection to be taken orally mixed with water. Be aware that it will take time for the patient to restabilise.