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DRAFTv12d
SCHEDULE 2 – THE SERVICES
A.
Service Specifications
Mandatory headings 1 – 4. Mandatory but detail for local determination and agreement
Optional headings 5-7. Optional to use, detail for local determination and agreement.
All subheadings for local determination and agreement
Service Specification No.
Service
Community Anticoagulation Services
Commissioner Lead
NHS Birmingham South Central CCG
Provider Lead
Not applicable
Period
August 1st 2014 until July 31st 2017
Date of Review
1.
Population Needs
1.1
National/local context and evidence base
NHS Birmingham South Central Clinical Commissioning Group (BSC CCG) is a clinically led
commissioning organisation, appointed by the Government to buy and monitor healthcare services
for approximately 250,000 people in the south and centre of Birmingham. Birmingham is ranked the
ninth most deprived local authority in England out of 354. It is one of the most diverse cities in the
country, with more than 100 languages spoken. BSC CCG is situated within the Birmingham local
authority boundary. It comprises 47 GP practices with an alliance of five established networks
serving Bournville, Brandwood, Edgbaston, Kings Norton, Longbridge, Moseley, Northfield, Selly
Oak, Small Heath, Sparkhill, Sparkbrook, Springfield, Nechells and Ladywood (see map at
http://www.bhamsouthcentralccg.nhs.uk/practices/practice-map).
Introduction
Anticoagulation therapy is required for patients at a high risk of suffering either a first or recurrent
episode of venous thromboembolism (VTE). For example either following a DVT or PE or in those
with atrial fibrillation (AF) or having a prosthetic heart valve(s) in-situ.
In developing this service specification the CCG has considered the needs of patients who require
anticoagulation including, accessibility, clinical quality and safety and choice.
The CVD Outcomes Strategy
Nationally through the Cardiovascular Disease Outcomes Strategy we are being encouraged to
improve CVD outcomes for our population. This includes improving the management of atrial
fibrillation and for those with other indications for oral anticoagulation; we are being encouraged to
provide choice within service provision and care closer to home.
Local Context
Patients of Birmingham South Central CCG Practices requiring an anticoagulation service have
benefited from traditional hospital out-patient haematology services, a local acute trust Transition
Service and an Any Willing Provider scheme that has been running for 5 years. Patient feedback has
shown that there are very high rates of satisfaction and involvement in decision making for both our
community clinics and hospital based services, although the community clinics were rated more
highly than the hospital services and we are seeking to increase our choice of community providers.
Patients have expressed a preference for a one stop service including point of care testing and
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dosing.
Evidence of Local Need
In Birmingham South Central CCG we currently have approximately 2600 patients attending
anticoagulation clinics and prescribe over a 1000 items of the newer oral anticoagulants such as
Dabigatran etexilate or Rivaroxaban. Furthermore, the QoF data (2011) have shown that 1 % of our
CCG population has AF diagnosed –the actual prevalence is approximately 33% higher when
compared to that expected for the over 45 age group. In the last year 316 CCG responsible patients
have been discharged with a diagnosis of VTE from one of our acute hospitals and 40 CCG
responsible patients have been discharged with a diagnosis of heart valve replacement.
Evidence base
Anticoagulation Services Survey Report (2013). Central Midlands CSU.
Baglin, T.P., Cousins, D., Keeling, D.M., Perry, D.J. and Watson, H.G. Recommendations from the
British Committee for Standards in Haematology and National Patient Safety Agency. British Journal
of Haematology, 136, 26-29.
Cardiovascular Disease Outcomes Strategy Improving outcomes for people with or at risk of
cardiovascular disease (2013). Department of Health, London
(https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/217118/93872900853-CVD-Outcomes_web1.pdf).
NHS Midlands & East (2012). Stroke Services Specification (http://www.angliacn.nhs.uk/nhsmidlands-and-east-stroke-services-review/) .
Keeling, D.M. et al. (2011). Guidelines on oral anticoagulation with warfarin – fourth edition. British
Journal of Haematology. Volume 154, Issue 3, pages 311–324.
National Institute for Health and Care Excellence. (NICE Clinical Guideline 36). (2006, June). Atrial
Fibrillation – the management of atrial fibrillation.
National Institute for Health and Care Excellence. (NICE Commissioning Guide 49). (2013, May).
Support for Commissioning: anticoagulation therapy.
National Institute for Care Excellence. (January 2014). Atrial fibrillation: the management of atrial
fibrillation. NICE guideline – draft for consultation.
National Patient Safety Agency (2007). Patient Safety Alert 18 – Actions that can make
anticoagulant therapy safer. Available online at http://www.npsa.nhs.uk/patientsafety/alertsanddirectives/alerts/anticoagulant/ Includes links to Patient safety alert, Workforce competency
statements, E-learning modules, Patient information, Risk assessment tool, British Journal
NHS England (2013). Everyone counts: Planning for patients 2014/15 to 2018/19.
Patient Safety First. Patient safety resources available online at
http://www.nrls.npsa.nhs.uk/resources/
Scottish Intercollegiate Guidelines Network. (2013). Antithrombotics: indications and management.
SIGN 129. Edinburgh. Healthcare Improvement Scotland.
2.
Outcomes
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2.1
NHS Outcomes Framework Domains & Indicators
Domain 1
Domain 2
Domain 3
Domain 4
Domain 5
2.2
Preventing people from dying prematurely
Enhancing quality of life for people with long-term
conditions
Helping people to recover from episodes of ill-health or
following injury
Ensuring people have a positive experience of care
Treating and caring for people in safe environment and
protecting them from avoidable harm
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Local defined outcomes
Birmingham South Central CCG is committed to delivering its “PPLEA” comprising of
prevention, partnership working, localism, education and access and quality of primary
care. Our end state ambition for 2015/16 involves (2012/13 baseline):
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Reduce the rate of preventable years of life lost from causes amenable to
healthcare from 2,608 to 2,588 per 100,000;
Improving the health related quality of life people with one or more long-term
condition from 70.3% to 70.7%;
Reducing the rate of avoidable emergency admissions (composite indicator) from
2,456.4 to 2,345.2 per 100,00;
Increasing the proportion of older people living independently at home following
discharge from hospital (trajectory to be set);
Reducing the proportion of people answering ‘poor’ in our Trusts as evidenced in
the national In-patient survey from 143 to 140.9 per 100 responses;
Reducing the proportion of people answering ‘poor’ or ‘fairly poor’ in relation to their
experience of GP surgery and out of hours care from 7.8 to 6.85 per 100 patients;
Making significant progress towards eliminating avoidable deaths in our hospitals
(trajectory to be set)
Decrease percentage of all medicines related incidents resulting in harm (trajectory
to be set).
Patient Satisfaction
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Providers will use an approved patient questionnaire (e.g. Appendix 4) for assessing patient
satisfaction of the service they provide. This should be carried out annually or as agreed with
the CCG
Providers will ensure that the patient questionnaire is accessible to all patients, e.g. to
include patients who’s first language is not English; patients with disabilities; and to support
patients who require help to complete their questionnaire
Providers will have the responsibility of providing and distributing the questionnaire to their
patients and enabling their return via a freepost address or by enabling the patients to return
them anonymously to a collection box at their clinic sites
Providers will collate the responses, analyse and consider the results, produce an action
plan and provide comprehensive feedback to the CCG and to patients in the form of a report
annually
Regular patient involvement from a diverse group of patients will be expected in the review
and development of the service and the results of the providers response to patient’s
comments are to be fed back annually in the report requested above unless requested by
the CCG more frequently.
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2.4
Service review
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2.5
Patient monitoring
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2.6
The Service Provider will provide a quality-assured responsive service
They will ensure there is regular monitoring to achieve:
1. The balance required between decreasing the risk of thrombosis and increasing the risk
of haemorrhage
2. Patient awareness of other factors that can affect their response to warfarin
3. Patients monitored as required according to latest British Committee for Standards in
Haematology guidelines
Quality Assurance
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2.7
Make available access to patient records by the Commissioner for the purposes of
assurance, investigation and public safety
Providers will need to undertake ongoing management of a minimum of 30 patients
receiving oral anticoagulation at any one time to ensure continued clinical competency and
cost effectiveness
Providers will need to ensure they receive and respond appropriately to regular health alerts
and ensure their processes and procedures are up to date with current guidance.
Adverse incidents and clinical emergencies
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3.
Providers will be expected to annually review and where necessary (e.g. after significant
events) update their written procedures and clinical protocols in order to ensure their service
provides, up to date, evidence based and safe clinical practice. Any proposed updates
should be approved by the commissioner prior to implementation
Providers are responsible for the annual review of individual patients including the review of
the indication and appropriateness of continued anticoagulation with warfarin.
Providers will have policies and procedures on the management of clinical emergencies.
Staff will be trained in the implementation of these. There will be policy and procedure for the
reporting of adverse incidents to the patient’s GP and secondary care consultant (as
appropriate), CCGs Lead Quality & Safety, and to comply with NPSA reporting.
Scope
3.1
Aims and objectives of service
Aim of the service
To provide on a equitable basis, a safe and effective initiation, stabilisation, monitoring, dosing and
prescribing ‘One Stop Shop’ anticoagulant management service for non-complex and stable complex
to patients aged 16 and over, registered at a Birmingham South Central GP practice in Birmingham,
in line with National Guidance. The service will minimise the potential adverse effects of warfarin by
providing patients with regular monitoring to stabilise the International Normalised Ratio (INR) levels
while continuing to maximize the effective benefits of such treatment.
The service will have equitable access, ensuring that patients are treated with dignity and respect,
are fully informed about their care and are able to make decisions about their care in partnership
with healthcare professionals.
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Objectives of the Service
To provide standardised and clinically effective anticoagulation management of patients receiving
warfarin therapy whilst minimising the risks associated with anticoagulation, following nationally
recognised and clinical safe standards
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To initiate warfarin for suitable non-complex patients
To produce optimum management of INR control
To educate patients in the understanding of their treatment, in terms of their condition
requirement for warfarin, target range for INR, the effects of over and under anticoagulation,
diet, lifestyle and drug interactions
To support the CCG’s policy in delivering of NOACs and initiate NOAC therapy when
suitable with referral back to the patient’s GP
To support the CCG’s Outcomes Indicators
To provide a quality service that is underpinned by the NHS Outcomes Framework
To appropriately manage patients who are over anti-coagulated according to a protocol
agreed with the commissioner (see appendix 1 for an example)
To maintain a register of all patients receiving warfarin and have a treatment plan for each
patient that is reviewed on a regular basis
To review the appropriateness of continued anticoagulation at each visit
To identify and manage appropriately, patients with specific needs i.e. difficulties with
concordance, unstable INR control or accessibility issues
To optimise care to patients receiving anticoagulant therapy in terms of accessibility,
continuity and waiting times
To ensure complete and accurate documentation of the clinic process
To produce KPIs and prepare an initial and then annual audit implementing and
documenting actions in response to findings
To respond appropriately and in a timely way following notification of changes in coprescribed medication.
3.2
Service description/care pathway
Non-complex and stable patients aged 16 and over, registered to a GP practice in Birmingham
South Central CCG, will access initiation, stabilisation, monitoring, dosing and prescribing
anticoagulant services, close to the patients home and accessible to all regardless of where they live
or personal service ease-of-access need. Domiciliary visits will be available to patients who meet
the definition set by the commissioner, (see appendix 2). Services will be provided and specific
outcome measures will be assessed for those patients as part of the performance indicators. Patient
expectation should be monitored and managed by the service provider to ensure inappropriate visits
are minimised.
The frequency and the number of monitoring appointments will be patient specific with the aim of
becoming less frequent as the patient achieves and maintains therapeutic range.
All patients will receive education and information about their treatment and management in
accordance with written procedures and clinical protocols, in order to make decisions about their
care in partnership with healthcare professionals.
The service will have equitable access, ensuring that patients are treated with dignity and respect,
are fully informed about their care and are able to make decisions about their care in partnership
with healthcare professionals.
It is critical that the provider identifies and manages appropriately, patients with specific needs i.e.
poor compliance, housebound patients, unstable INR control, or frequent non attendees, and to
ensure the service conforms to equality legislation.
The service must optimise care to patients receiving anticoagulant therapy in terms of accessibility,
continuity and waiting times, and must offer patient choice of provider and best treatment available.
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The service model will comprise the following elements. These are:
Registration- the registration of the patient including completion of software database
Assessment and initiation – the confirmation of indication for anticoagulation, counseling for
initiation and patient education
Monitoring – including point of care testing so that current INR status can ascertained during
clinic visit with the provision of accredited equipment including test strips
Dosing – Deciding the appropriate dosing of anticoagulant based on applying clinical
experience to the findings of the decision support software
Prescribing – The issuing a prescription on an FP10 based on the dosing decision
Additional provision
Domiciliary – the ability of the community anticoagulation clinic to visit patients within their
home setting to carry out the core service elements
Alternatives to warfarin – the ability of the community anticoagulation clinic to offer NOACs
within local clinical guidelines
Self Testing – the ability of the community anticoagulation clinic to offer self –testing with the
provision of testing strips, yearly external quality control of monitoring machine and remote
dosing on a named* patient basis
Temporary Residents – the ability of the community anticoagulation clinic to sign on
temporary residents and offer the core service (see 3.31 Financial Information)
For definitions see 3.3.
This service specification is set out in such a way as to encourage innovation on the part of the
provider service. The emphasis is on service outcomes and commissioner expectations and not on
how the service should be delivered.
*If a patient wants to self-test then they will need to apply to the CCG for agreement until the CCG’s
policy on self-testing changes – responsibility for external quality control of the patient’s device is the
responsibility of the provider in collaboration with the patient.
3.3
Population covered
The service will be offered to patients registered with a member Practice of the commissioning CCG.
This will include stable non-complex patients as a core service. Additional categories of patients are
as defined below:
Complex patients
This service is designed to conveniently and safely monitor the majority of non-complex patients
where initiation and on-going anti-coagulation management is not problematic. The Provider should
consider carefully providing a service for complex patients, and complex patients might include the
following:
 A known hereditary or acquired bleeding disorder
 Alcohol dependency
 Severe malnourishment due to absorption difficulties
 Liver failure
 Severe renal impairment
 Documented evidence of CNS haemorrhage
 Severe heart failure
 Uncontrolled severe hypertension
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GI bleeding in the last 6 months
Pregnancy
Those on chemotherapy for malignant tumours
Children under age of 16
Homozygous protein C deficiency
Pre-stabilised VTE patients
Unstable patients
Patients on renal dialysis should normally attend a secondary care unit for their anticoagulation.
Domiciliary
An individual, by way of physical or psychological illness or due to social circumstances is unable to
leave their usual place of residence to access services and is determined housebound by the
provider according to criteria set out in Appendix 2.
Unstable patients
An unstable patient is one whose time in therapeutic range (TTR) remains below 40% despite
frequent attendance for monitoring and dosing or who is subject to frequent medication change or
because of poor concordance is unable to follow dosing regime.
3.4
Any acceptance and exclusion criteria and thresholds
3.4.1 Referral Pathway
Providers are expected to operate the pathway as set out below. Referrers will be expected to
complete a standardised referral form (Appendix 3). The Provider has the right to refuse to accept a
patient or continue to offer a service if ;
 the referral form is not completed in full (the referral form should be returned to the
originator within one working day, for completion or referral to an alternative provider
 the patient is outside the Provider’s competence
 the patient moves CCG and there is no reciprocal funding arrangements
 there is a breakdown in relationship between the patient and Provider
Communications
Communications would normally be via NHSmail or through the use of safe haven faxing, and the
use of the NHS Choose & Book referral system is the preferred method of managing referrals.
Complex patients as set out in section 3.3 should not be referred to or accepted for treatment by the
service. It is recognised that some patients in the defined ‘Complex Patient’ groups may be suitable
for monitoring within the new service if their condition improves and stable control is established. In
such situations robust communication between different providers will be vital to allow for safe
transfers of care to happen.
The Provider should be working towards or currently able to receive referrals through the national
NHS Choose & Book electronic referral system as set out within the NHS standard contract. In the
case where a referrer is unable to use or access Choose & Book, an alternative (i.e. paper) referral
process should be accepted.
All service providers should receive referrals electronically, safely and securely using NHSmail to
NHSmail email or through the use of safe haven faxing.
The patient will be contacted within five working days of receipt of final completed referral to arrange
and appointment.
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Referral Pathway
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For those patients who are referred via the Indirect Bookable Service where patients will contact and
make appointments themselves, but fail to make contact with the Provider a reminder will be sent
and the patients GP notified.
3.4.2 Communication and Liaison
The Provider will be expected to inform the patient’s general practitioner of the patient care plan and
all activity within in clinically appropriate time period. All activity include advising the GP of any
symptoms of ill health, significant events, death, INR over 8, administration of vitamin K, clinic nonattendance, details of annual reviews or referral or admission to hospital. Information should be
transferred by fax or email (NHS net) or NHS electronic connections when incorporated across
providers to the nominated contact.
The Provider will develop and adhere to a “Did Not Attend” (DNA) policy that has been agreed by the
CCG, reviewed annually and revised as appropriate.
The Provider will communicate with GPs and secondary care services to retrieve medical information
and vice-versa as necessary including:
 further patient information re health status
 results of relevant pathology tests
 details of other medication
3.4.3 Transfer
In exceptional circumstances e.g. relocation or patient choice; the patient can enroll with an
alternative provider within a twelve-month period. However, if a discontinuation of treatment occurs
(after coming to the end of the specified treatment period) and then recommenced within one month
with the same provider, the provider will only receive one fee.
The Provider will use, as a reference for minimum requirements, Appendix 3 of this specification, to
transfer patient information to another provider, including information that will enable another
provider to meet their duties under the Equality Act 2010. This will ensure safe and continuation of
care. The information should be transferred within one week to the new Provider.
3.5 Eligibility to Provide
3.5.1 Accreditation of staff
As part of the accreditation process, the clinical lead and all performer staff who will be involved in
near patient testing and/or dosing MUST have undertaken formally recognised training for an
anticoagulation stabilisation and monitoring service that has been agreed by the CCG (course
content that is equivalent to the standard of a “Masters” module).
The NPSA has also developed competences for anticoagulant therapy which include:
 Initiating anticoagulant therapy
 Maintaining anticoagulant therapy
 Managing anticoagulants in patients undergoing dental surgery
 Reviewing the safety and effectiveness of an anticoagulant service
[Details of these competences are available at the following web link:
http://www.nrls.npsa.nhs.uk/resources/?entryid45=61790&q=0%C2%ACanticoagulant%C2%AC]
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3.5.2 Facilities and Training
Prior to service roll out, Commissioners require assurance that Providers have the facilities, clinical
experience, training and competence as is necessary to provide an anticoagulation stabilisation and
monitoring service as laid down in this specification.
Providers must assure Commissioners prior to commencement that the NPSA Alert 18 checklist has
been completed.
The Provider must maintain a Continuing Professional Development database of the staff delivering
the service which identifies attended, scheduled and review training dates as part of the annual audit
cycle.
3.6 Registration
The Provider will keep comprehensive registration and management records for all patients referred
into the service by using the agreed proprietary software. Providers will be responsible for the
licensing of the software, ensuring compatibility with their own clinical system or on either an
integrated or on a “stand-alone” basis. All documents must be stored safely and securely by the
Provider and be open to clinical scrutiny as appropriate. The Provider will also be expected to
operate a call and recall system for each patient.
3.7 Informing patients and carers
The Provider undertaking this service will:
 Ensure patients are fully educated regarding their condition and are fully involved in the
planning of their treatment programme including the use of visual aids to support
concordance
 Prepare with the patient an individual management plan; that outlines the diagnosis, planned
duration and therapeutic range to be obtained
Ensure that each patient receives both verbal and written advice (NPSA Oral Anti-coagulation
Therapy Pack including the “Yellow Book”) and that this information is in the appropriate format
depending on the needs of each patient.
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In some circumstances, provided the patient has given consent, treatment and planning may
be discussed with the patient’s family and/or carer
Ensure all staff are sensitive to the cultural, ethnic and communication needs for people
whom English is not a first language, including BSL users or who may have cognitive and/or
behavioural problems or disabilities. These factors should be taken into consideration to
facilitate effective consultations. Arrangements for consultation with non-English speakers
and those with sensory impairments should be provided at no additional cost to the
commissioner of this service or the patients.
Ensure a telephone advice line or other appropriate medium depending on the needs of all
service users, is in place for patients who require advice regarding their anti-coagulation
management. Contact details must be clearly printed on the patient’s information booklet
and must state when advice is available. The Provider will make arrangements for efficient
and timely response to patient enquiries within one day of receipt.
Ensure the patients are aware of how they obtain advice or treatment OOHs of the service
being provided
Ensure all patients referred to the service (and/or their carers and support staff where
appropriate) understand how to manage and prevent complications of their condition
including the provision of patient-held booklet, referring back to their GP as appropriate for
further support
Where patients do not have the capacity to make decisions, healthcare professionals should
follow the DH guidelines – ‘Reference guide to consent for examination and treatment’
(2009).
Any communication material for release to patients and public or potential referrers will be
agreed in advance with the commissioners.
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3.8 Clinical Protocol
The provider must operate according to a clinical protocol that will comply with the recommendations
of national regulations and directives relating to anti-coagulation and shared with the lead
commissioner prior to service commencement.
The service provider must ensure that the clinical protocol includes arrangements for the patient to
access a safe supply of anticoagulant medication. The service provider must ensure that the patient
understands how to do this.
3.9 Assessment and Treatment Process
Provide patients with a clearly advertised range of days and times of appointments at a location
convenient to the patient.
During the first appointment (new patients), the service provider will:
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Complete education and assessment of patient / carer understanding of their condition and
stabilisation and monitoring process for anti-coagulant therapy.
Ensure the patient has all information available to them to facilitate their understanding of
the management plan in a suitable format (NPSA Oral Anti Coagulation therapy Pack
including a Yellow Book).
Perform capillary testing and dosing
Record current dosage information and any reasons for changes in the service-held patientspecific record and dosage information in yellow book or suitable alternative computer
printouts
Determine and document whether the patient currently receives their medication in a
monitored dosage system, NPSA guidance for communication of dosage adjustments for
these patients must be followed
Advise the patient/carer regarding the need to advise their surgeon/dentist that they are
taking anticoagulants prior to any surgery/dental procedures in line with NPSA
recommendations
Agree a monitoring plan with the patient including the mode of service to be accessed, the
site and frequency of visits including the next appointment at a date and time convenient to
the patient. Considerations should be made regarding the mobility of the patient, travelling
distance to the nearest clinic and an assessment of the level of supervision the patient
requires
Each Follow Up monitoring appointment the Provider will provide service as described for first
appointments above and:
 Review the therapeutic reason and duration for the patient to be on anticoagulation e.g.
following ablation for AF and the timescale highlighted at point of referral
 Discuss any abnormal/unusual results with the patient to establish and document the cause
and prevent future problems, including establishing the actual dose taken and the timing of
dose.
 Reinforce patient education and management
 Provide details of the next appointment which will be at a date and time convenient with the
patient but clinically appropriate
3.10 Red Flags
Where the operative is unable to obtain an INR from a near patient testing device or where there is
cause for concern about the reliability of the result, the service provider should send a sample to a
local hospital laboratory or refer back to the patients GP practice for venous testing, whilst
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undertaking appropriate management.
The management of INRs outside the required therapeutic range should follow an approved protocol
(an example for over anticoagulation is shown in appendix 1).
3.11 Domiciliary Appointments
The majority of appointments will be clinic based, however a service for Care Homes and domiciliary
patients must be provided. Clinical judgment and/or dialogue with the patients registered GP will be
used to determine whether or not a patient requires a home visit (see appendix 2).
The service provider has a responsibility for ensuring the relevant person (patient, carer,
pharmacist or support worker) is aware of the any dose changes and the implications for use
and the risk of non-compliance
In the case of a home visit, the provider is expected to take all necessary equipment with them to
provide the full service at this location. Where a technician attends a patient’s home, the dosing
should be carried out and the patient informed prior to 5pm the same day, where there is a dosing
change and within one working day where it is safe to do so, with appropriate supporting information
in a format the patient understands
3.11 Failure to Attend Appointments
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In the event of a patient failing to attend a single clinic appointment or to provide a sample of
blood, as arranged, the service provider will contact the patient within one working day of the
missed appointment to arrange a further appointment
If this attempt is unsuccessful, three additional attempts should be made to contact the
patient/carer over the next two weeks. The service provider should attempt to contact the
patient by the most suitable method for the patient.
The service provider will inform the patients GP within three days of the patient’s failure to
attend after the fourth unsuccessful attempt
If the patient is under the care of mental health services, a named healthcare professional
(listed on the referral form) will be contacted if the patient fails to attend.
Management and outcomes of patients failing to attend appointments will be monitored by
the Commissioner and detailed in the minimum data set laid out in the core contract.
3.12 Discharge Process
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At the end of the required treatment course (as specified as per above) or if otherwise
indicated, anticoagulants should be discontinued as recommended in the British
Haematological Society guidelines on Oral Anti-Coagulation 1998 (updated 2005) and the
patient’s GP should be informed in writing within two working days
The Provider should maintain a record when treatment is discontinued as to the reason for
discontinuation / discharge from the service in line with data regulations. This information
should be stored safely and securely and retained by the service and made available for
inspection and audit if required.
3.13 Location of Service Delivery
The service will be provided from appropriately equipped premises within the boundaries of
Birmingham South Central CCG. Suitable premises may include Primary Care Centres, Community
Hospitals, General Hospitals, General Practitioner surgeries and Community Pharmacies with
appropriate facilities. All premises should be easily accessible, with good transport links and fit for
purpose; they may be subject to inspection on an annual basis by the commissioner of the service
which will include the following:
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Compliance with the Equality Act 2010
Infection Control
Safe and Secure Handling of Medicines and waste
The service provider will grant visiting rights to relevant public and patient involvement forums in
respect of premises provided or used by the service for delivering healthcare under this contract.
3.14 Response Time and Prioritisation
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The service provider will ensure that information regarding the management of patients by
the service is relayed to the patients GP within two working days (including where the
provider is a GP or other clinician, information on medication prescribed if the provider
prescribes warfarin for the patient and when treatment is discontinued to ensure removal
from the patients repeat prescription record which will be done as part of the discharge
process).
The service provider will identify, record, investigate and report to the Commissioner (as
soon as information becomes available to the provider) any serious untoward incidents
associated with anticoagulant therapy including emergency admission in line with the
Commissioner’s protocol for handling serious untoward incidents. Deaths should be reported
to the Commissioner within one working day or as soon as this information becomes
available to the service provider.
It is expected that referred patients will be able to contact the provider by telephone or other
appropriate medium, in order to discuss appointment times and for other advice within one
day.
3.15 Equipment
The provider will ensure all equipment:
 Complies with current health and safety regulations and maintain minimum standards for
satisfactory patient care
 Is properly maintained and calibrated in accordance with manufacturer instructions.
 Is fit for purpose
 Complies with Medical Devices Legislation
The Provider will be responsible for:
 All necessary near-patient testing equipment (including single use lancets and test strips)
 Consumables
 Quality assurance materials to be commissioned through accredited suppliers
 Clinical waste
The service provider must ensure that external quality assurance checks are conducted on a
minimum quarterly basis to verify the accuracy of blood testing machinery and dosing. Using NEQAS
(National External Quality Assessment Scheme), these quality assurance checks will be funded by
the service provider and will be submitted to the commissioner of this quarterly as part of the
minimum dataset and as an annual report.
3.16 Computerised Decision Support Software
It is expected that the Provider will use an accredited bespoke Computerised Decision Support
Software (CDSS) system in agreement with the CCG. The Provider will be responsible for the cost of
14
the license fee (s) for the agreed system and the CCG will make arrangements to host Server.
If computer software is used to assist dosing decisions, the service provider must:
 Ensure the most up-to-date clinical version of the software is used
 Ensure that all staff using the software receive training and are competent to do so
 Ensure all data stored on the computer system is subject to the requirements of a
comprehensive data protection policy
Any proposed change in proprietary software (CDSS) needs to be agree with the commissioner.
In addition, the decision support system should have the facility to generate patient information
including visual prompts for their Warfarin dose with both numerical and colour diagrammatic
representation of tablets required.
3.17 Patient Transport
Patients will be expected to arrange their own transport to the services provided unless they qualify
under the Healthcare Travel Costs Scheme guidance found at:
http://www.nhs.uk/NHSEngland/Healthcosts/Pages/Travelcosts.aspx
The service provider is expected to advise the patient on all local transport options on request, this
includes community transport availability
3.18 Clinical Governance & Patient Safety
The service provider is required to carry out clinical audit of the care of patients set criteria
recommended by the British Committee for Standards in Haematology and the National Patients
Safety Agency and as indicated in the Contract Module B Part 8.1
3.19 Information Requirements
The Provider will fully complete the required dataset for every patient referred to and accessing the
service. It will be the service provider’s responsibility to ensure the submission of the quarterly
clinical audit in a timely manner.
Information systems, where possible must be interoperable with primary and secondary care
systems to support seamless transfer of electronic information.
In all circumstances relating to transfer of patients from one provider / referrer to another robust
communication between different providers will be vital to allow for safe transfers of care to happen.
The referral and registrations forms should be used as minimum requirements for ensuring the right
patient information is transferred and communicated. Providers will have a standard operating
procedure for the handling of patient information and the content of such. This will be shared with
Commissioners prior to service commencement.
3.20 Audit
The service provider is required to carry out a clinical audit after the first 3 months of service, and
quarterly thereafter, of the care of patients against criteria recommended by the British
Haematological Committee for Standards in Haematology and the National Patient Safety Agency.
3.21 Accessibility /Acceptability
The service will have equitable access, and ensure that patients are treated with dignity and respect.


The Provider must work with commissioners to identify locations which ensures the best
possible access for patients
The Provider must accept referrals for all patients within the cohort, regardless of gender
sensitive issues, culture, disability, or housebound status or other “Protected Characteristics”
15



The Provider must contribute to reducing health inequalities through offering an inclusive
and accessible service to vulnerable and easily over looked groups.
The Provider must ensure all patients are given every opportunity to fully engage with the
service
The Provider must provide appropriate access at variable times for all patients
The provider has a responsibility to ensure that every service actively promotes equality of health
outcomes for people with learning disabilities and cognitive impairment. The Provider shall;







Provide training to relevant staff to ensure that health professionals gain a greater
awareness of the health issues for people with learning disabilities and the ‘reasonable
adjustments’ to services that may be required to meet their needs.
Provide information both pre and post appointment in an accessible format with the use of
pictures or symbols to back up information.
Use clear concise language and seek confirmation that people understand what is
communicated to them.
Provide flexibility in appointment times, with longer time being allotted, appointments at the
beginning or the end of the session to avoid waiting or allowing time for people to feel
comfortable.
Consult parents, family or paid carers on the needs of the individual and the best way to
meet those needs where appropriate.
Where made available by the referrer, consult the person’s ‘Care Plan’ on the needs of the
individual and the best way to meet those needs where appropriate
Consult local specialist learning disability or liaison staff on the needs of the individual and
the best way to meet those needs where appropriate.
3.22 Exclusion criteria




Patients not registered at a GP practice with NHS Birmingham South Central CCG
Patients under the age of 16
Patients with a known hereditary or acquired bleeding disorder as defined under ‘complex’
patients.
Patients who may develop co-morbidities or other clinical conditions that may make it
inappropriate or outside the competency of the provider to manage in primary care. These
patients should be referred back to the initiating clinician if already managed in primary care,
and should not be accepted for management by the provider.
3.23 Interdependence with other services/providers
Providers will be expected to have a close working relationship with all Health and Social Care
professionals relevant to the pathway including:
 GP Practices
 Acute services
 Community Pharmacies
 Specialist services
 Commissioners
 GP IT system providers
 Nursing and Residential Homes
 Medicines Management
 CCG Quality and Safety Teams
16
3.25 Prescribing




Providers must ensure clinicians providing the anticoagulation service who are prescribing
are clinically qualified and competent. Prescribing must be in accordance with the NPSA
recommendations, www.npsa.nhs.uk/health/alerts
Providers will be expected to provide complete anticoagulation management care including
the prescribing of warfarin and the first month of NOACs. The CCG will arrange for service
and prescriber codes to be used on FP10 prescriptions attributed to the service for all
prescribing for the Prescription Pricing Division at the Business Services Authority for
service monitoring. The costs of prescriptions for drugs only, will be coded to the patient’s
GP prescribing budget
Providers must ensure patient details can be stored and accessed electronically and
computerised prescriptions can be produced
For the majority of patients prescribing would be carried out by the Provider. When
requested by the patient’s GP and the patient, arrangements could be made by the provider
to enable the patient’s GP to carry out prescribing in accordance with NPSA
recommendations although this is not the preferred ‘modus operandi’.
3.26 Set up arrangements and costs


The costs of the monitoring process will be met by appointed providers
Anticoagulant blood monitoring must be undertaken using appropriate devices validated by
the Purchasing and Supply Agency (PASA) with appropriate Standard Operating Procedures
which include appropriate quality assurance processes.
3.27 Risk management and adverse event reporting
All staff are expected to adhere to guidance on the assessment of risk and the management of risk
appertaining to the treatment of patients and the safety of staff as described at:
http://www.npsa.nhs.uk/patientsafety/improvingpatientsafety/riskassessment-guides/
Providers will be expected to up date their risk reduction strategies on a regular basis and according
to updated research.
3.28 Compliance with relevant legislation
Service providers must ensure that staff comply with all relevant legislation
for example:



Health and Safety legislation and Control of Substances Hazardous to Health (COSHH)
legislation
NICE guidelines on Infection Control (2003)
Statutory employment legislation including that relating to equal opportunities and antidiscriminatory practices.
3.29 Accident and significant event reporting and monitoring


The Provider’s policy on accidents and significant event reporting and monitoring should
accord with CCG requirements. This should comply with NHS recommendations and
including reporting to the NPSA or its replacement body.
Significant events should be recorded and reported one working day to the CCG Quality &
17



Safety Lead
If the CCG Quality & Safety Lead is not available then reports should be made to a CCG
Senior Management Team member
A report on action taken and action to be taken will be sent to the CCG within 10 days of any
reported accident or significant event.
All enquiries from the press, media and politicians etc to be directed to the South
Birmingham CCGs Partnership Team to agree appropriate response, in line with the CCGs
Media Handling Policy.
3.30 Indemnity Insurance
Providers must ensure that they have adequate levels of current indemnity insurance throughout the
term of the formal Framework Agreement and be prepared to show commissioners evidence of such
upon request at any time. Insurance cover should be for a minimum of £10 million as at April 2014
and should be reviewed annually by the provider throughout the term of the formal Framework
Agreement to ensure its adequacy.
3.31 Financial information
 The contract currency will be based on a payment of £206 per patient managed per annum.
The cost of £206 per patient (2014/15) will be subject to annual review that is likely to reflect
the level of efficiencies and inflation specified by the Department of Health for that year
 The payment for a temporary resident/NOAC initiation will be £60 booking fee and follow up
of £20 per patient for each of up to two follow-up visits chargeable in any one quarter
 The year of care payment will be divided into four instalments per annum, paid quarterly in
arrears based on the average number of patients to whom an anticoagulation service is
being provided. The average number will be calculated from the opening number registered
on the first day of the quarter plus the closing number registered on the last day of the
quarter divided by two.
 Under the any willing provider model of service, there are no guaranteed volumes of activity
for providers, and consequently no minimum or maximum contract value, other than the
minimum activity level required to maintain safe practice as detailed
 There is no block or retainer element within the contract.
 Providers will be required to submit activity monitoring information according to an agreed
dataset and timetable to support the contract monitoring and payments processes.
 CDSS licence fee will be met by the provider
3.32 Complaints
Providers must provide and operate a complaints policy for both patients and staff which reflects the
principles contained with the CCG Complaints Policy and is in accordance with NHS guidance.
Providers must make available details of complaints received as required by the CCG.
3.33 Disputes
 Disputes within the provider organisation will be handled by the provider.
 A dispute resolution procedure may be invoked by either party to the Contract if there is a
failure to agree. This may occur either before or after the Contract is agreed. The disputes
procedure has two stages: mediation, followed by adjudication if the dispute remains
unsettled
 Disputes involving NHS Trusts will be mediated by NHS England
 At the mediation stage the decision about the solution to the dispute remains with the two
parties to the Contract (CCG and provider). The two parties will be assisted to come to a
resolution through the good offices of the relevant NHS England. In order to invoke the
disputes procedure, the two parties concerned must submit to the NHS England a document
signed by both parties that describes the precise points over which they disagree. If NHS
England is satisfied that the nature of the dispute has been adequately documented, they
will invite the parties to describe their own solution to the dispute. The parties will have five
working days to provide this documentation, and a further five days to comment on the other
party’s solution. At the end of this time the mediators will invite the parties to agree
18


If a dispute cannot be resolved at the mediation stage, NHS England will adjudicate
The costs of the adjudication will be borne by the unsuccessful party to the dispute
4.
Applicable Service Standards
4.1
Applicable national standards (e.g. NICE)
NICE (May 2013). Support for Commissioning: anticoagulation therapy
NICE TAG 275 (2013). Apixaban for the prevention of stroke and systemic embolism in people with
non-valvular atrial fibrillation.
NICE TAG 256 (2012) Rivaroxaban for the prevention of stroke and systemic embolism in people
with atrial fibrillation.
NICE TAG 249 (2012) Dabigatran etexilate for the prevention of stroke and systemic embolism in
people with atrial fibrillation with one or more risk factors for stroke or systemic embolism.
NICE clinical guideline 76 (2009). Medicines adherence: involving patients in decisions about
prescribed medicines and supporting adherence.
4.2
Applicable standards set out in Guidance and/or issued by a competent body (e.g.
Royal Colleges)
See Evidence Base
4.3
Applicable local standards
BSC CCG Safeguarding Policies
BSC CCG Information Governance Policies
BSC Updated NOAC Policy (when available)
[Birmingham, Sandwell and Solihull Cardiac and Stroke Network (May 2012). Dabigatran or warfarin
for treatment of Atrial Fibrillation: Position statement.]
[Birmingham, Sandwell and Solihull Cardiac and Stroke Network (May 2012). Rivaroxaban or
warfarin for treatment of Atrial Fibrillation: Position Statement.]
5.
Applicable quality requirements and CQUIN goals
5.1
Applicable quality requirements (See Schedule 4 Parts A-D)
Providers should note that for the year 2014/15 the KPI “patient experience” is the CQUIN
equivalent.
19
Applicable quality requirements
Providers will need to ensure the following key performance indicators are met and will be asked to
report on these:
Quality Performance
Indicator
Threshold
Method of
measurement
Consequence of
Breach
QUALITY INDICATORS
Point Prevalence:
1. Dosing efficiency
of INR tests within
0.5 units
2. Dosing efficiency
of INR test within
0.75 of target INR
Service time in
Therapeutic Range
TiR:
??
60%
60% minimum
90%
Providers should aim
to complete all data
fields in the agreed
proprietary software
Infection Control
Annual infection
prevention self audit
using the CCG
infection prevention
tool and/or visit
Action/rectification plan
to be
submitted to
Commissioner for
agreement
Quarterly: Clinical
Decision Dosing
Support System audit
report
Action/rectification plan
to be
submitted to
Commissioner for
agreement
80%
Patients should be
within therapeutic
range at a given point
in time after initial
stabilisation
Data Completion
Quarterly: Clinical
Decision Dosing
Support System audit
report
90%
Commissioner Audit
and reconciliation –
quarterly
Self Audit using CCG
tool programme with
minimum attainment
of 90%
Action plan/rectification
plan submitted to
commissioner for
agreement
Action/rectification plan
to be
submitted to
Commissioner for
agreement
Personalised Care
Planning:
Individual care plans
agreed between
patient and provider.
Self declaration
100%
Action/rectification plan
to be
submitted to
Commissioner for
agreement
20
Waiting Times for
First Appointment
Patients contact
initiated within 5
working
days of receipt
of completed
referral form
100%
Management of
Failed to Attend for
First and Follow-up
Appointment
Self declaration:
Yearly Quality &
Performance Report
Action/rectification plan
to be
submitted to
Commissioner for
agreement
Self declaration:
Yearly Quality &
Performance Report
Action Plan to be
submitted to
Commissioner
within mutually agreed
timescales
Yearly Quality &
Performance Report
Action Plan to be
submitted to
Commissioner
within mutually agreed
timescales
Yearly Quality &
Performance Report
Action Plan to be
submitted to
Commissioner
within mutually agreed
timescales
100%
Yearly Quality &
Performance Report
Action Plan to be
submitted to
Commissioner
within mutually agreed
timescales
At least 40% survey
response rate of
sample. The sample
must be the Providers
whole patient
caseload
Yearly report on
patient experience
Action Plan to be
submitted to
Commissioner
within mutually agreed
timescales
100%
Yearly Quality &
Performance Report
Action Plan to be
submitted to
Commissioner
within mutually agreed
1. Patients who DNA
– first attempted
contact within 1
working day.
85%
2. Patients who DNA
– four attempts
made to contact
the patient within
2 weeks
95%
3. Patients GP
informed of DNA
within 3 working
days after 4th
unsuccessful
attempt to contact
the patient.
85%
4. Alternative
appointment
dates offered to
patients who have
DNA’d within 2
weeks of contact
with them.
Patient Experience of
the Provider’s
service**** (see
appendix 4)
Reporting and
Information Sharing
Patients GP is
informed within
two working days
of discharge
21
timescales
Safe Transfer of
Care
Patients
transferred to
another provider or
back to referring
clinician, robust
evidence that
communication
and documentation
between different
clinics has been
shared
Full compliance robust evidence that
communication
and documentation
between different
clinics to ensure
safe transfer of
care
Yearly Quality &
Performance Report
on exception basis.
Clinical Audit
Clinical Audit Data set
is submitted to
commissioners on a
quarterly basis (see
Appendix 5)
100% return rate
Quarterly Data set
provided to the
commissioner
Action Plan to be
submitted to
Commissioner
within mutually agreed
timescales
Inappropriate
Referrals
Full compliance
Quarterly dataset
provided to the
Commissioner
Action Plan
Audit by
commissioners
Action Plan to be
submitted to
Commissioner
within mutually agreed
timescales
100% of
inappropriate
referrals
returned to
referrer within 2
working days of
receiving referral
Cancelled
Appointments
% of
Appointments
cancelled by
Provider
Patient safety
Reporting of all
incidents to
commissioner within 2
days of provider
becoming aware of
incident.
5.2
5%
100%
Quarterly dataset
provided to the
Commissioner
Reported on template
provided by
commissioner
Applicable CQUIN goals (See Schedule 4 Part E)
Action Plan to be
submitted to
Commissioner
within mutually agreed
timescales
Action Plan to be
submitted to
Commissioner
within mutually agreed
timescales
22
Providers should note that for the year 2014/15 the KPI “patient experience” ****is the CQUIN
equivalent.
6.
Location of Provider Premises
The Provider’s Premises are located at:
7.
Individual Service User Placement
23
Appendix 1
See UHB guideline below as example (with thanks to UHB fT)
Taken from Over Anticoagulation with Warfarin UHBfT 2012: clinical guideline
24
Appendix 2
Proposed Eligibility for Domiciliary Anti-coagulation Care
The following criteria provide a guideline only. The decision to offer and deliver a domiciliary service
rests with the Provider of the service.
The patient receives domiciliary care from their own general practitioner.
The patient is entitled to ambulance transport for routine hospital attendances.
The patient rarely leaves their usual place of residence without substantial assistance.
The patient is not able to use a taxi for travel.
The patient’s mobility is restricted to less than 10 meters unaided or is confined to a wheelchair and
has limited access to support or is effectively bedbound or chairbound.
25
Appendix 3
Anticoagulation Service Referral Form
Referred to (Anticoagulation
Service clinic address):
Date Referral Made:
Date Referral Received:
Referrer Name and
Address (Referrals should be
made by clinicians only):
PATIENT INFORMATION
Title:
Date of Birth:
Forename
NHS Number:
Surname:
Home Telephone:
Gender:
Next of Kin:
Address:
Post Code:
GP Name and
Address:
Preferred
Contact Method:
Mobile Number:
26
‘NEXT OF KIN’ INFORMATION
Title:
Relationship:
Forename
Home Telephone:
Surname:
Mobile Number:
Address:
Post Code:
Summary of Medical History, Medication, and Allergies
Medical history
(Active problems:
AS~AM~PS~FT):
Hypertension
history:
Diabetes Mellitus
history:
History of Stroke,
TIA, Heart Failure,
CHD, liver disease:
Current medication:
Known allergies:
CHADS score
Renal function:
LFTs
FBC/PT
27
Indication for Anticoagulation:
Intended duration of Anticoagulation:
Advised target range for INR:
Patient suitable/capable to take Warfarin:
Yes
No
Patient is able to attend the Anticoagulation Clinic: Yes
No
Patient is housebound*:
Yes
No
Patient lives alone:
Yes
No
Patient has dementia:
Yes
No
This patient has not yet commenced oral anticoagulant therapy
This patient has started taking Warfarin on
and is due an INR test on
and is currently being managed by the anticoagulation service at
.
Their most recent two INR results and Warfarin doses are:
Date
INR
Dose
Date
INR
Dose
Thank you for arranging to see this patient with a view to managing their oral
anticoagulant therapy.
Signature of
Clinician:
Print Name:
Date:
Please include a print out summary of the patient’s medical history/summary
28
(*: If the patient is housebound or likely to become housebound in the next few
years they should be referred to the nearest anticoagulation service.)
29
Appendix 4
Anticoagulation monitoring
Patient questionnaire
What is this questionnaire about?
Thank you for agreeing to complete this questionnaire, which has been designed for patients who receive anticoagulation
monitoring in General Practice.
Who should complete this questionnaire?
Primary care staff is trained to provide services that previously would have required you to visit a hospital. These services are
called ‘enhanced’ services.
If you have accompanied a patient to the surgery, and that person needs help to complete the questionnaire, please give the
answers from his/her point of view.
You do not need to put your name on the questionnaire; all your answers will be treated as confidential. When you have completed
the questionnaire, please [post it in the box provided / give it to a member of the practice staff].
Any questions or need help?
If you have any queries about the questionnaire, please speak to a member of the practice staff.
Thank you for your help.
30
Please answer these questions about the anticoagulation monitoring service
Please rate each of the following by circling one answer on each line: (1) Poor, (2) Fair, (3) Good, (4) Very Good, or (5)
Excellent
Q1 My involvement in decisions about my care and treatment is…
1
2
3
4
5
Q2 The explanation given about my care and treatment is…
1
2
3
4
5
Q3 My confidence in the staff’s knowledge is…
1
2
3
4
5
Q4 The courtesy and respect I am shown is…
1
2
3
4
5
Q5 My satisfaction with the service I receive is…
1
2
3
4
5
Please put a cross in the appropriate box
Q6 Please identify the member of staff who is normally involved in your anticoagulation monitoring
General Practitioner (GP) [ ]
Practice Nurse or Nurse Practitioner [ ]
District Nurse [ ]
Health Care Assistant [ ]
Someone else (please state) __________________________ [ ]
I am not sure who looks after me [ ]
31
Q7 Have you considered the option to choose another provider/clinic for your regular anticoagulation monitoring?
[ ] Yes
[ ] No
[ ] Not aware of options
[ ] Happy with current provider
Please rate each of the following by circling one answer on each line (1) Strongly Agree, (2) Agree, (3) Uncertain, (4)
Disagree, (5) Strongly Disagree
Q 8 It is easy to contact the staff about my warfarin treatment
1
2
3
4
5
Q9 The staff listen to me and give me time to discuss my Warfarin
1
2
3
4
5
Q10 Do you feel your access requirements are being met by your clinic? E.g. disability access, car parking, availability
and timing of appointments i.e. especially in relation to those in employment, warfarin literature available in different
formats, etc.
1
2
3
4
5
Please make any other comments or suggestions for improving our service:
Thank you for completing this questionnaire. Please post it in the box or return it to a member of the practice staff.
32
Appendix 5
Anticoagulation Service Provider Audit Data summary for year 2014/2015
Name of Any Qualified Provider....................................................................
Audit parameter
AUDIT DATE
NAME of PERSON
COMPLETING THE
AUDIT
Referrals
The proportion of
inappropriate
referrals received
No. of inappropriate
referrals returned
within 2 working
days
TIME IN RANGE
over previous 12
months (TiR)
Quarter ending
Quarter ending
Quarter ending
Quarter ending
30.06.14
30.09.14
31.12.14
31.03.15
33
TiR <25% (for
current quarter)
TiR 26 – 50% (for
current quarter)
TiR 51 – 75% (for
current quarter)
TiR >75% (for
current quarter)
VARIANCE
% of INRs > 1.0 INR
unit below target
% of INRs > 5
% of INRs >8
POINT
PREVALENCE
(include date of
PP)
ADVERSE
EVENTS (AE),
document nature of AE
34
and the outcome
Major (AE)
Moderate (AE)
Minor (AE)
CLINIC
ATTENDANCE
No. of patients
registered with the
service
No. of patients
attending
appointments at the
clinic
No. of patients
requiring a home
35
visit
No. of patients with
overdue INR test, +
document action
taken to resolve this
No. of patients
referred to
secondary care
Percentage of
patients lost to follow
up + document
action taken to
resolve this
No. of patients who
have passed
expected end date
of treatment +
document action to
resolve this
No. of patients
referred to service
with unknown
diagnosis/target
Percentage of
patients with no
yellow book prior to
36
starting warfarin
Proportion of
cancelled
appointments by
Provider
Percentage of
patients with no
yellow book during
on-going treatment
Possible source of data





Time in Range: CDSS TiR report
Variance: CDSS Variance Report
Point Prevalence: CDSS –Point prevalence report (standard report)
Adverse events: CDSS – Adverse event report
Clinic attendance: form CDSS reports or manual records
Additional comments:
.................................................................................................................................................................................................................
.................................................................................................................................................................................................................
.................................................................................................................................................................................................................
.................................................................................................................................................................................................................
................................................................
Audit data submission to the CCG by Providers:
37
All audit results should be submitted to the CCG via NHS Central Midlands CSU ([email protected]) and
any manual records (if required) should be send to Patricia James at NHS Central Midlands Commissioning Support Unit, Kingston
House, 2nd Floor | 438-450 High Street, West Bromwich | B70 9LD



All completed quarterly audits must be received at the CCG by the 10th July, 10th October, 10th January and 10th April 2015
for 2014-15.
Information regarding the number of patients that have undergone an annual review should be available for checking at the
annual visit from the CCG commissioner (dates of patient’s annual review could be extracted from CDSS „Advanced
Report‟ „Patient’s Audit‟).
The following documents should be regularly updated and made available for checking by the Commissioning
Lead/Contracts Manager during the annual visit by the CCG to the Provider. Documents should also be available for
verification on a “spot check” basis where the CCG Commissioning Lead/Contracts Manager feels this may be necessary.
o Training documentation of health care professionals involved in the anticoagulation service, to include:




Copies of training certificates, including annual refresher course attendance certificates
Records and competence assessment.
CDSS competency certificate
Records to include clinical supervision & assessment in practice.
o Procedures/protocols for the following should be in place:




Details of Near Patient Testing (NPT) equipment/reagents/reagent failure
Protocol for NPT management
Records of Internal Quality Control (IQC) and External Quality Control (EQC).
Guidance for over and under anti-coagulation.
38
 Domiciliary visits and hospital transfers.
 Guidance for management of patients who are taking co-prescribed interacting medicines.
 Discontinuation of warfarin.
 Referral procedures for patients:
o being transferred to another provider
o being admitted to hospital for elective surgery
 Protocol for safe initiation of anticoagulant loading doses, including the use of low dose loading for patients with AF.
 Protocol for patients who are self monitoring/self managing their INR.
 Protocol if CDSS is not available.

Results from the annual patient satisfaction questionnaire should be available for review at the annual visit from the CCG
commissioning lead.

In addition to reporting on CDSS, serious adverse events should be notified directly to the CCG’s Lead Integrated
Governance and Quality and Safety Manager ([email protected])

The Commissioning Lead and Head of Medicines Management should be notified immediately of any changes in the clinical
leadership of the Provider in order that records and CDSS can be updated accordingly.
39