ANNEX 2

NHS Eastern and Coastal Kent

Key Performance Indicators for Anticoagulation Therapy

This document applies to staff working within or on behalf of NHS Eastern and Coastal Kent. It is also regarded as providing good practice guidance to independent contractor organisations.

This document provides commissioners and service providers with:

  • A framework to ensure compliance with NPSA safety indicators for anti-coagulation therapy.
  • The PCT key performance indicators relating to the provision of anticoagulation therapy services.
  • The agreed care pathway for patients requiring anticoagulation therapy.
  • The PCT policy on local and national reporting mechanisms.

Valid from:1st May 2010

Review Date:1st May 2012

Lead Manager / Director: Sarah Andrews

Agreed by: Patient Safety Sub-Committee

NHS Eastern and Coastal Kent actively challenges discrimination and actively promotes equality. We will not restrict assessment, treatment, therapy or care on the basis of age, disability, gender, ethnic group, religion or belief, sexual orientation or any other irrelevant consideration.

1.Introduction.

1.1Anticoagulants are one of the classes of medicines most frequently identified as causing preventable harm and admission to hospital (NPSA 2007).

1.2This document is the agreed NHS Eastern and Coastal Kent health economy care pathway, for healthcare providers who are initiating, maintaining, referring or discontinuing patients on anticoagulation treatment. It includes the treatment of both stable and unstable patients.

1.3This policy applies to all providers of anticoagulation services for NHS Eastern and Coastal Kent.

1.4Supporting documentation added April 2010 via the Anti-coagulation Working Group, Sub-Group of the CVD Service Improvement Group

2.NPSA Patient Safety Alert

2.1This document is based on the most recent evidence and best practice recommendations described in the 2007 Patient Safety Alert from the National Patient Safety Agency (NPSA), “Actions that can make anticoagulant therapy safer”.

2.2In primary care, anticoagulants are one of the classes of medicines most commonly associated with fatal medication errors. In secondary care Warfarin is one of the ten drugs most frequently associated with prescribing/dispensing errors. The NHS Litigation Authority has reported that anticoagulants are one of the ten most common drugs involved in errors resulting in claims against NHS Trusts.

2.3 The following pages describe the safety indicators from the NPSA alert. These must be followed by all healthcare providers who are treating patients with anticoagulation therapy.

The policy is set out as a series of measurable objectives and benchmarks.

For NPSA links see appendix 1.

3.Benchmarks and expected best practice.

Objective 1 – To ensure that there is a robust mechanism in place to ensure that all staff caring for patients on anticoagulant therapy have the necessary work competencies.

Benchmark of expected best practice – There are processes in place,to ensure that all staff have required work competencies.

To demonstrate standards of best practice for objective 1 the PCT, organisations, practitioners, managers and staff should ensure that:

  • All services commissioned and provided by and on behalf of the PCT and by independent contractors have arrangements in place to identify the required work competencies for staff.
  • Any gaps in competence must be addressed through training to ensure that all staff undertake their duties safely.

Actions that organisations, services and practices should be taking to make sure best practice is achieved:
1.1. / It is compulsory for the pharmacist(s) undertaking anticoagulation supply under the PGD to be accredited to supply under PGD by successfully completing the following training:
Either
1) the CPPE open learning module “Anticoagulation: managing patients, prescribing and problems”, including CPPE on line “Anticoagulants – supporting patients and ensuring safety” examination
OR
2) the BMJ module “maintaining patients on anticoagulants : how to do it”.
The latter is most useful to pharmacists wishing to offer anticoagulation monitoring and supply services.
Medicines use review (MUR) accreditation.
Copies of completion certificates must be sent to Linda Barnard, Pharmacy Contract Manager, NHS Eastern and Coastal Kent, Templar House, Tannery Lane, Ashford, KentTN23 1PL and originals retained on file as evidence.
In addition, pharmacists must be familiar with the contents of Service Specification etc
Signed documents should be returned to : Linda Barnard, Pharmacy Contract Manager, NHS Eastern and Coastal Kent, Templar House, Tannery Lane, Ashford, KentTN23 1PL
Pharmacists must be reaccredited every two years.
For information relating to training and to access the PGDs for anticoagulation monitoring and dispensing, please use the link below:

1.2. / Evidence of individual competence and clinical supervision.
1.3. / Identification of any gaps in training or resource requirements to ensure compliance.

Objective 2 - To ensure that there are written procedures and clinical protocolsin place thatreflect safe practice.

Benchmark of expected best practice – Healthcare organisations should have clinical policies and clinical protocols for the safe use of oral anticoagulant therapy.

To demonstrate best practice for objective 2 the PCT, organisations, practitioners, managers and staff should ensure:

  • The PCT, organisations and services willhavewritten procedures and protocols in place.
  • There must be a structured process in place to review and update polices – local policies should be amended to standardise the range of anticoagulant products used, incorporating characteristics identified by patients as promoting safer use.
  • Staff must be trained in, and work to theseprocedures and protocols.

Actions that services and practices should be taking to make sure best practice is achieved:
2.1. / Evidence of written, agreed protocols (where applicable to the service), for the following:
Initiation;
Monitoring;
Documentation processes for results and treatment;
Discharge and transfer process;
Regular monitoring of INR and assurance that level is safe before issuing or dispensing repeat prescriptions for oral anticoagulants;
Annual reviews;
Discontinuation;
Strength of anticoagulation medication (described in mg NOT number of tablets);
Dosage recommendations; guidance for anticoagulation;
Standard INR checking frequency (appendix 2);
Identify stable and unstable, to ensure patient safety throughout the pathway (appendix 3).
2.2. / Aprotocol to manage overcoagulation; request for venous sampling and giving phytomenadione.
For information relating to training and to access the PGDs for anticoagulation monitoring and dispensing, please use the link below:

2.3. / A protocol to manage undercoagulation.
2.4. / Evidence of guidance for the use of Sodium Heparin infusions (to include records of ward stock locations and purchasing records of heparin >1000unit/ml products), where applicable.
2.5. / A process is in place to ensure documents have been subject to the correct ratification and dissemination process.

Objective 3 – To ensure that patients prescribed anticoagulants receive appropriate verbal and written information at the start of therapy, at hospital discharge, at the first anticoagulant appointment, and when necessary throughout the course of their treatment.

Benchmark of expected best practice – To ensure that there are processes in place to ensure patients receive information throughout the care pathway.

To demonstrate best practice for objective 3 the PCT, organisations, practitioners, managers and staff should ensure:

  • Organisations, services and practices will have processes in place to ensure provision of information to patients
  • Organisations, services and practices will have processes in place to ensure that patient receipt of information is recorded.

Actions that services and practices should be taking to make sure best practice is achieved:
3.1. / Evidence that a range of patient information is available (i.e. a selection of documentation from the Patient and Carers section on the NPSA website
3.2. / Documented innotes that patient has been given information and that patient has acknowledged it – a checklist to be used that patient must sign.

Objective 4 – To ensure that there is a structured auditprogram in place.

Benchmark of expected best practice – Annualdocumented audit of safety indicators.

To demonstrate best practice for objective 4 the PCT, organisations, practitioners, managers and staff should ensure:

  • Audit of safety indicators for patients starting oral anticoagulant treatment.
  • Audit of safety indicators for patients established on oral anticoagulant treatment.
  • Recommendations and action planning based on results of audits.

Actions that services and practices should be taking to make sure best practice is achieved:
4.1. / Audits of safety indicators for patients starting oral anticoagulant treatment to include the following criteria:
For documentation audit:
  • % of patients following loading protocol – prospective audit of prescription charts over one month.
  • % of INRs >5.0 – results from monitoring service over 12 months
  • % of patients in therapeutic range at discharge – prospective audit of prescription charts over one month.
  • % of new referrals to anticoagulant service (hospital or community based), with incomplete information – Results from anticoagulant clinic (s) over 12 months–suggestion: referral checklist that can be signed off by receiving service and will remain with patient notes for future audit.
  • % of patients that were not issued with patient-held information and written dosage instructions at the start of therapy – results from anticoagulant clinic(s) over 12 months - suggestion: referral checklist that can be signed off by receiving service and will remain with patient notes for future audit.
  • % of patients that were discharged from hospital without an appointment for the next INR measurement or for consultation with appropriate healthcare professional to review and discuss treatment plan, benefits, risks and patient information – results from anticoagulant clinic(s) over 12 months.
From admissions data:
  • % (incidence) of patients suffering a major bleed in the first month of therapy and % suffering major bleed with INR above the therapeutic range – results from hospital admissions and clinical data over 12 months.
  • % patients suffering adverse outcomes, categorised by type, e.g. major bleed – results from hospital admissions over 12 months.

4.2. / Documented audit of safety indicators for patients established on oral anticoagulant treatment to include the following:
  • Proportion of patient-time in range or % of INR’s – results from monitoring service over 12 months.
  • % of INR’s > 5.0 – results from monitoring service over 12 months.
  • % of INR’s > 8.0 – results from monitoring service over 12 months.
  • % of INR’s >1.0 INR unit below target (e.g. % of INR’s <1.5 for patients with target INR of 2.5) – results from monitoring service over 12 months.
  • % of patients with unknown diagnosis, target INR or stop date – results from anticoagulant clinic (s) over 12 months.
  • % of patients with inappropriate target INR for diagnosis, high and low – results from anticoagulant clinic(s) over 12 months.
  • % of patients without written patient educational information – results from anticoagulant clinic(s) over 12 months.
  • % of patients without appropriate written clinical information e.g. diagnosis, target INR or last dosing record in their INR record books (yellow books) – results from anticoagulant clinic (s) over 12 months.
From admissions data:
  • % patients suffering adverse outcomes, categorised by type, e.g. major bleed – results from hospital admissions over 12 months.

4.3. / The audit programme will include audits that ensure compliance with CARE QUALITY COMISSION (CQC), NHSLitigation Authority (NHSLA) and, where required, QOF standards.
4.4. / The audit results are used to make recommendations for continuous quality improvements to the services, evidenced by action planning and implementation of the same.

Objective 5 – Promotion of the use of safe procedures in social care settings and domiciliary visits.

Benchmark of expected best practice – There are written safe practice procedures for the administration of anticoagulants in social care settings and domiciliary visits.

To demonstrate best practice for objective 5 the PCT, organisations, practitioners, managers and staff should ensure:

  • Social care settings (e.g. care homes; day centres; support living centres), should have written procedures for administering anticoagulants.
  • Dosage changes to be confirmed in writing by the provider.
  • The use of monitored dosage systems should be individually risk assessed and other means of administration sought where possible.
  • All providers must undertake domiciliary visitsand must have written procedures for administering anticoagulants.

5. / Actions that services and practices should be taking to make sure best practice is achieved:
5.1. / Written practice procedures in the care setting/domiciliary visit.
5.2. / Changes have been confirmed in writing by the provider.
5.3. / The use of monitored dosage systems for anticoagulants should be used with care and caution as dosage changes using these systems are difficult.
5.4. / Anticoagulation therapy services have processes in place to ensure risk assessments are undertaken on the use of monitored dosage systems for individual patients.

Objective 6 – Recording of patient safety incidents and near miss reporting.

Benchmark of expected best practice – That there is a robust procedure in place to record patient safety incidents and near miss reporting involving anticoagulants.

To demonstrate best practice for objective 6 the PCT, organisations, practitioners, managers and staff should ensure:

  • Incidents involving anticoagulants are reported via the organisations risk management process (e.g. PCT incident reporting system).
  • A record of all incidents, actual and potential, is maintained. (see CARE QUALITY COMISSION (CQC) and QOF).

6. / Actions that services and practices should be taking to make sure best practice is achieved:
6.1. / A process is in place to ensure all incidents and near misses are reported (e.g. incident reporting system).
6.2. / A record of all incidents, near misses and potential incidents is maintained. This information should include those areas required by the NPSA (see appendix 4).

Copies of the PCT incident reporting documentation can be obtained from the following link :

Objective 7 – Interactions and dental treatment.

Benchmark of expected best practice – That there are robust procedures in place to manage interacting medicines and dental treatment.

To demonstrate best practice for objective 7 the PCT, organisations, practitioners, managers and staff should ensure:

  • Promotion of safe practice for prescribers co-prescribing one or more significantly interacting medicines.
  • Patients should be advised to inform their dentists that they are taking anticoagulation medication.

7. / Actions that services and practices should be taking to make sure best practice is achieved:
7.1 / A process will be in place to promote safe practice for prescribers co-prescribing one or more significantly interacting medicines for patients already on oral anticoagulants, (to make arrangements for additional INR blood tests and to inform the anticoagulant service that an interacting medicine has been prescribed).
7.2 / A process to ensure that the additional safety precautions above have been taken.
7.3 / Documented in notes that patient has informed their dentist that they are taking anticoagulation medication – a checklist to be used that patient must sign. In most cases, dental treatment should proceed as normal and oral anticoagulant treatment should not be stopped or the dosage decreased inappropriately.

Objective 8 – Quality control

Benchmark of expected best practice – There are robust procedures in place to manage stable and unstable patients; INR checking frequency, choice of systems; calibration of equipment; waste disposal; discontinuation of patients on anticoagulation treatment.

To demonstrate best practice for objective 8 the PCT, organisations, practitioners, managers and staff should ensure:

  • Organisations, services and practices must include the agreed health economy definition of stable and unstable patients, within their protocols – see appendix 3 for definition.
  • DAWN is the preferred system of choice. INR Star is the ONLY other acceptable system.
  • Organisations, services and practices must use the agreed health economy INR checking frequency – see appendix 2.
  • All providers MUST be registered with UK NEQAS.
  • CoaguChek machines to be calibrated in line with manufacturer’s recommendations.
  • All providers must have a policy in place for disposal of clinical waste.
  • The preferred length of treatment is to be written in the patient’s yellow book by the clinician initiating treatment.
  • Providers make use of the nursing helpline – numbers in appendix 7.

8. / Actions that services and practices should be taking to make sure best practice is achieved:
8.1 / A protocol is in place which incorporates the agreed health economy definition of stable and unstable patients.
8.2 / Evidence that only DAWN or INR Star systems are in use.
8.3 / A protocol that incorporates the agreed INR checking frequency.
8.4 / Evidence of current UK NEQAS registration.
8.5 / A written waste disposal policy is in place.
8.6 / Evidence of calibration of CoaguChek machines.
8.7 / Evidence that the preferred length of treatment is documented in the patient’s yellow book by the clinician who initiated treatment.

Objective 9 – Supply and/or administration

Benchmark of expected best practice – There is a PGD in place for supply and/or administration.

To demonstrate best practice for objective 9 the PCT, organisations, practitioners, managers and staff should ensure:

  • There is a PGD in place for the supply of anticoagulants and the administration of phytomenadione.Information can be accessed via:
9. / Actions that services and practices should be taking to make sure best practice is achieved:
9.1 / The PGD must cover the supply of anticoagulants.
9.2 / The PGD must cover the administration of phytomenadione.

Appendix 1

NPSA links

Appendix 2

Standard INR checking frequency

Appendix 3

Stable and unstable

Appendix 4

Patient safety incidents – information required by the NPSA

Appendix 5

Patient care pathway algorithm

and forms 1 2 3 5 6

Appendix 5b

Patient Transport

Appendix 6

Audit Checklist

Appendix 7

Medical and nursing support for primary care anticoagulant clinics

Appendix 8

Accreditation Doc

Appendix 1

NPSA links:

Web link to NPSA site:

Which links to the following information:

NPSA Patient Safety Alert (NPSA/2007/18):

Template Service Audit Form:

Risk Assessment Grid:

Appendix 2

Standard INR checking frequency

After 1 result in range recheck after 1 week

After 2 results in range recheck after 2 weeks

After 3 results in range recheck after 3 weeks

After 4 results in range recheck after 5 weeks

After five results in range recheck after 8 weeks