NHS Eastern and Coastal Kent

Service Specification for Monitoring Anti-Coag LES for Pharmacies

1 July 2011-31 March 2013

Local Enhanced Service for Monitoring Anti-Coagulation Medication for Pharmacies

Service Specification 1 July 2011 – 31 March 2013

Author / Ally Hiscox
Version / 4.0
Ratified by / Enhanced Services Project Board
Date Issued / 01/07/2011
Review Date / 31/03/2012
Contact Point for Queries / Ally Hiscox, Lead Commissioner, Cardiovascular

ContentsPage

1Service Aims

2Service Specification

2.1Training and Accreditation

2.2Facilities and Equipment

2.3Confidentiality

3Controls

3.1Context

3.2Standards

3.3Provider Assurance

3.4Variations

3.5Termination

3.6Clinical Audit

4

4.1Data to be created and stored by Provider

4.2Data to be routinely reported for payment and validation

4.3Communication with other providers

5Finance Details

6Signature Sheet

7Anticoagulant Monitoring Schedule (also known as Annex 1)

1Service Aims

The overall aim will be to provide an integrated anticoagulation service across primary and secondary care. In particular, the Enhanced Service will:

  • Provide more services that are near to patients and are easily accessible
  • Ensure that maintenance of patients on anticoagulants is properly controlled and the need for continuation of therapy is reviewed regularly and therapy is discontinued where appropriate.
  • To improve safety, access and convenience for patients who receive anticoagulation therapy.
  • To take into consideration recommendations from the NPSA report on the safety of anticoagulation therapy services.
  • To assist in medicines management and reduce waste.
  • To ensure a full record of each patient’s medication is stored both at the dispensing pharmacy and on the patient’s GP system.
  • To refer patients to specialist services where appropriate.

2Service Specification

  1. The service provider will provide an anticoagulation monitoring service using the appropriate recommended CoaguChek monitor and the approved monitoring IT software (DAWN or INR Star)
  2. This service will be available to any stable and non complex patient (as determined by secondary care specialists) registered with an NHS Eastern and Coastal Kent GP, including housebound patients.
  3. Access routes to this service are dependent on the provision, by the patient, of the Anticoagulant Care Record (Yellow Book). This must be completed with patient’s name, address, date of birth, GP, individual haemophilia centre number, relevant blood test results and dosing schedule from the nominated blood testing clinic. Also to be included are name and contact details of the clinic, name of anticoagulant, condition requiring treatment, target INR, intended duration of treatment and date treatment commenced.
  4. This service specification is for a monitoring service only. A separate service specification is required for the provision of an associated dispensing service.
  5. The PCT will provide initial start-up equipment, including IT software, monitoring systems and training. However the cost per case price reflects ongoing costs of these items plus any necessary consumables and maintenance.
  6. The provider will use an approved IT systemto produce an up to-date register of all anti-coagulation monitoring service patients, indicating patient name, date of birth, the indication for, and length of, treatment, including the target INR, in accordance with KPI as set out in Annex 2.
  7. The provider will ensure that systematic call and recall of patients on this register is taking place within the provider setting, or offer domiciliary visits where clinically indicated.
  8. The provider will ensure that, where clinically indicated, patient transport is offered in accordance with relevant PCT policy, see Annex 2, Appendix 5b
  9. The provider will work with other professionals when appropriate. Any health professionals involved in the care of patients in the programme should be appropriately trained.
  10. When appropriate, to refer patients promptly to other necessary services and to the relevant support agencies, the provider will use locally agreed guidelines where these exist.
  11. The provider will maintain adequate records of the performance and result of the service provided, incorporating appropriate known information, including the measurable indicators set out in the KPI. This may include the number of bleeding episodes requiring hospital admission and deaths caused by anti-coagulants.
  12. All providers are expected to maintain their own stock of consumables including, amongst other items, latex gloves, hand sanitizer, testing strips and solutions.
  13. Changes to the KPI document can be made at anytime, however resulting impact on service provision will require the PCT to give three months’ notice period, unless a shorter notice period is clinically indicated.
  14. The provider will maintain their own IT hardware in accordance with other contracts held with the PCT.
  15. Neither the PCT nor the Provider will be liable for delay or failure to perform its obligation under this agreement if the delay or failure results from circumstances beyond their reasonable control.
  16. The provider will provide medicines advice to the patient, monitor concordance and refer to specialist services in accordance with KPI.
  17. Patients should be encouraged to use the same pharmacy for supply of all medications including over the counter.
  18. Should a patient share concerns about physical conditions such as bruising, bleeding gums or foot care problems, appropriate advice and referral should be sought.
  19. Providers of this service who also provide the Anticoagulant Dispensing service must be compliant with both service specifications and KPIs.
  20. The provider will perform a routine annual review of each anti-coagulation patient to determine if they require continued anti-coagulation therapy.
  21. The provider will ensure that the days and times the service is offered remain the same each week. Providers should, where possible, avoid service delivery on Fridays. The provider will inform the PCT of changes to the day/time of availability of the service prior to the change occurring. (Note, one-time or very short term changes due to illness or annual leave do not require reporting to the PCT.)
  22. The provider will ensure that the monitoring schedule is determined by clinical need. The provider must ensure that arrangements are in place to accommodate additional tests eg a patient who requires an additional test pre-surgery. Providers must ensure this request is from a legitimate source.
  23. The provider must ensure they have robust business continuity plans in place for this service. This must be updated annually.

2.1Training and Accreditation

The provider will ensure that all staff, involved in providing any aspect of care under this scheme, has the necessary training and skills to do so.

The provider will ensure sufficient members of staff are trained to ensure provision of service in the event of unforeseen absence or termination of employment.

The provider will provide electronic copies (eg scanned) of all training certificates to the PCT as detailed at Annex 1 and Annex 2, Appendix 8

2.2Facilities and Equipment

Service location should be accessible by public transport.

Any location should be Disability Discrimination Act compliant.

Services must be provided in environments which promote effective care and optimise health outcomes by being well-designed and well maintained with cleanliness levels in clinical and non clinical areas that meet the national specification for clean NHS premises.

Appropriate arrangements must be made for the regular maintenance and safety checks of equipment, according to the manufacturer’s schedule

Appropriate arrangements must be made for suitable carriage of any portable equipment, according to the manufacturer’s schedule.

2.3Confidentiality

The provider (which term includes its employees, agents and all others authorised by it) shall respect the confidentiality of all information relating to patients, carers or other users of the service. They will comply with The Confidentiality and Disclosure of Information: The Pharmacy Contract, the Data Protection Act 1998 and all other relevant legislation.

This requirement does not preclude appropriate sharing of information where proper legal authority for such sharing exists.

Providers must supply the PCT with a named individual email contact for this service. This must be an active NHS NET address.

3Controls

3.1Context

This specification operates within the General Pharmaceutical and Local Pharmaceutical Services contracts.

3.2Standards

All providers will be expected to adhere to the standards set out in the “Key Performance Indicators for Anticoagulation Therapy Monitoring (KPI)” which are appropriate to the monitoring procedure. This is supplied as Annex 2 to the service specification.

The KPI document sets out the agreed pathway for patients requiring anticoagulation therapy, local and national reporting mechanisms and ensures that the services (and service providers) are able to comply with National Patient Safety Agency (NPSA) safety indicators.

All health and adult social care providers are required by law to be registered with the Care Quality Commission (CQC) or equivalent in respect to Pharmacy providers. General Practice providers must be registered by April 2012 and must demonstrate that they are meeting the essential standards of quality and safety These standards are subject to monitoring and inspection by the CQC.Compliance with relevant NICE guidance is also required.

The provider must ensure that NHS infection control standards comply with The Health Act 2006: Code of practice for the prevention and control of healthcare associated infections and NICE clinical guidelines on infection control and prevention of healthcare-associated infection in primary and community care (

Providers are responsible for ensuring that all personnel working with vulnerable groups undergo an enhanced CRB check. Activity associated with working in vulnerable people’s own homes is regarded as ‘regulated activity’ as defined in the new Independent Safeguarding Authority regulations ( is currently an offence to allow anyone who will be involved in regulated activity to start employment without checking with the ISA for anyone who is currently barred and on the vulnerable adults barred list or children’s barred list – see for details.

Please also see Objective 2 in the Safeguarding Benchmarking Policy on Staffnet (under revision, but this is still current)

All staff must be aware of and adhere to the Kent & Medway Safeguarding Vulnerable Adults Multi-Agency Policies, Protocols & Guidance, which can be found at:

And Kent & Medway SafeguardingChildrenProcedures, which can be found at:

For further safeguarding information, please contact Andrew Coombe, Head of Safeguarding, NHS Eastern and Coastal Kent.

T: 01227 795009 M: 07796 675014

Providers are responsible for ensuring that all personnel are issued with and display at all times appropriate photographic identification in the course of their duties relating to this service.

3.3Provider Assurance

Providers will be required to satisfy the PCT’s provider assurance process before the provider may commence this service by completing and returning to the contracts office Annex 1 and associated documentation outlined in the accreditation documentation (see Annex 2, Appendix 8).

3.4Variations

All variations to this specification must be formally agreed between the PCT and the provider and confirmed in writing prior to the commencement of the service

3.5Termination

Termination of this agreement may not take place within the first threemonths, except for reasons of clinical quality or performance.

The PCT may terminate the service by giving not less than threemonths notice in writing to the provider.

The provider may not terminate the service without the prior written agreement of the PCT.

In the event of termination of this service, it will be the responsibility of the provider to ensure that all patients cared for under the providers’ service are offered choice of new provider and safely and seamlessly transferred in accordance with the appropriate pathway (see Annex 2, Appendix 5).

3.6Clinical Audit

The provider will carry out audit of the care of patients in accordance with the KPI as at Annex 2.

Additionally, the provider must agree to participate in any PCT-led clinical audits associated with this enhanced service.

4

4.1Data to be created and stored by Provider

Patient identifier i.e. NHS number

Procedure carried out

Please refer to attached KPIs

All activity should be coded and recorded appropriately

4.2Data to be routinely reported for payment and validation

Activity levels to be reported monthly via invoice.

Activity report to be produced using the IT software (DAWN or INR Star), containing patient number, total number of INR tests carried out during the period and explanatory notes of any outliers. Guidance notes for production of report at Annex 3, Appendix 1 (INR Star) and Appendices 3 to 5 (DAWN).

Manual override report showing number of occasions when tester overrode the IT system. Guidance notes for production of report at Annex 3, Appendix 2 (INR Star) and Appendix 6 (DAWN).

4.3Communication with other providers

For communication across the healthcare system, see pathways and forms in Annex 2, Appendix 5. The patient identifier is the NHS number.

5Finance Details

  • This agreement is to cover a period from 1stJuly 2011 (or commencement of service, whichever is later) until 31 March 2013.
  • Providers will receive a payment per monitoring appointment of £25.00, to be reviewed annually. During 2011/12, the PCT will be able to review the payment schedule due to the revised reporting requirements (see section 4). Providers will be notified of any changes.
  • Providers will receive an additional payment of £5.00 for each monitoring appointment conducted in an individual’s home as a result of that individual patient’s housebound status.
  • Occasionally, a community provider may be contacted by the Haemophilia Centre, EKHUFT or local Haematologist to work in partnership in the provision of anti-coagulation monitoring, eg a housebound patient who is complex and unstable. In this instance, the enhanced service provider may claim for this patient via the provider activity form on a monthly basis.
  • The provider will claim via the provider activity form on a monthly basis.
  • In the first year only, providers may also invoice for:
  • The cost of purchasing anticoagulation monitoring IT software
  • The cost of two CoaguChek monitors
  • Payments cannot be backdated beyond the date which the service commenced.
  • The PCT purchases the initial training for this service direct from the Haemophilia Centre, EKHUFT. This relates to the cost of the training course fees only. It does not include any costs incurred by the provider in relation to transport to the training venue or costs associated with backfill for existing healthcare services. Providers wishing to access alternative initial training (i.e. not via EKHUFT) are liable for this cost.
  • The Provider is responsible for the following costs:
  1. NEQAS registration
  2. Consumables
  3. Training in relation to equipment and software that is not included in the training provided via EKHUFT
  4. CRB (Criminal Records Bureau) checking

6Signature Sheet

This document constitutes the agreement between the PCT and the Provider relating to the Enhanced Service for Monitoring of Anti-Coagulation medication. It replaces and supersedes all previous communications, representations and agreements between the parties for this service.

All providers are required to provide essential services and those additional services they are contracted to provide to all their patients. This specification defines more specialised enhanced services to be provided. This specification covers the enhanced aspects of clinical care of the patientwhich are beyond the scope of essential services. No part of this specification by commission, omission or implication defines or redefines essential or additional services.

Signature on behalf of the Provider:

Signature & Name (please print) / Provider Name/Stamp / Date

Signature on behalf of the PCT:

Signature & Name (please print) / Position / Date
Linda Barnard / Pharmacy Contract Manager

Note: Original signed document to be retained by the PCT Primary Care Team, Templar House, Tannery Lane, Ashford, KentTN23 1PL

7Anticoagulant Monitoring Schedule (also known as Annex 1)

Pharmacy Name

______

Pharmacy Code

______

Name of Pharmacist providing service

______

Please provide a secure email address, which is regularly monitored, for electronic transfer of future documents.

______

Hours service available at the pharmacy/clinic
Monday
Tuesday
Wednesday
Thursday
Friday
Saturday

Note: Completed Anticoagulant Monitoring Schedule must be returned to the Linda Barnard, Pharmacy Contract Manager, Templar House, Tannery Lane, Ashford, KentTN23 1PL along with the signature sheet.

Enhanced Service for Monitoring Anti-Coag for Pharmacies

Version 0.3

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1 July 2011-31 March 2013