Home based near patient testing for anticoagulation therapy - [under review] (G122)

In NHS Ayrshire and Arran there are approximately 3500 patients receiving this treatment and monitored from either a GP practice, hospital based clinic or on a shared care model.

The duration of anticoagulant treatment varies from a period of time to lifelong treatment for cardiac indications or recurrent thrombosis.

Patients taking medication require regular blood samples to be taken to measure the International Normalised Ratio (INR) which determines the patients oral anticoagulation dose. The monitoring of patients taking oral vitamin K and / or anticoagulants has traditionally been carried out in hospital clinics, with a trend over the last few years for this service to be transferred locally for patients to primary care.

Near patient testing in primary care enables patients access to anticoagulant monitoring and care near to their home, receive blood results and be advised of any dose adjustment within a very short time span There is also the additional benefit of a reduced need for venepuncture as blood samples are taken from the patients finger using a lancet device.

Oral anticoagulation management in primary care via a near patient testing (NPT) system has been shown to result in effective therapy management this being comparable with previous secondary care management, and having the obvious additional benefits of reduced travel to hospital services.

To ensure equality of access for patients this NPT system requires also to be available for patients in the community that are housebound and unable to attend a clinic facility. Community nurses, working with partners in GP practices, community pharmacies provide a key role in supporting this provision.

Purpose of the guideline

Oral anticoagulation management in primary care via a near patient testing (NPT) system has been shown to result in effective therapy management this being comparable with previous secondary care management, and having the obvious additional benefits of reduced travel to hospital services.
To ensure equality of access for patients this NPT system requires also to be available for patients in the community that are housebound and unable to attend a clinic facility. Community nurses, working with partners in GP practices, community pharmacies provide a key role in supporting this provision.

Scope of this guideline

The guideline applies to all Community Registered Nurses and healthcare support workers (HCSW) employed by NHS Ayrshire and Arran working with primary care teams who provide a near patient testing service for patients on oral anticoagulants.

Near patient testing should only be carried out when the Community Registered Nurse or HCSW have undergone training from the suppliers of the equipment chosen by their area. This will include a brief outline on the need for anticoagulation therapy and the side effects of the medication.

To ensure equality for patients this NPT system requires to be available for patients in the community who are housebound and unable to access a clinic facility. Community nursing staff working with partners in GP practices and community pharmacies provide a key role in supporting this provision.

Referrals for near patient testing may originate from:

• Hospital Anti-coagulant Service
• General practice
• Hospital consultants.

Definition of terms

Oral anticoagulation - blood thinning medication.

International normalised ratio (INR) - test which measures the time it takes for blood to clot and then compares it to an average.

Near patient testing - alternative system performed for patients delivered by health care workers out with the laboratory setting.

Community health index (CHI) - unique patient number identifier.

NEQAS - National External Quality Assessment Scheme.

Non-medical prescriber - A registered nurse, midwife, specific allied health professional or pharmacist who has completed a recognised prescribing course and this qualification is annotated within their professional regulatory body.

All guidelines and policies require review using the NHS Ayrshire and Arran Impact Assessment Toolkit by staff trained in this process.

Staff are reminded that they may have patients who require communication in a form other than English e.g. other languages or signing. Additionally, some patients may have difficulties with written material. At all times, communication and material should be in the patients preferred format. This may also apply to patients with learning difficulties.

In some circumstances there may be religious and/or cultural issues which may impact on this guideline e.g. choice of gender of healthcare professional. Consideration should be given to these issues when treating/examining patients.

Some patients may have a physical disability that makes it difficult for them to be treated/examined as set out in the guideline requiring adaptations to be made.

Patient’s sexuality may or may not be relevant to the implementation of this guideline however, non-sexuality specific language should be used when asking patients about their sexual history. Where sexuality may be relevant, tailored advice and information may be given.

This guideline has been impact assessed using the NHS Ayrshire and Arran Equality and Diversity Impact Assessment Tool Kit. No additional equality & diversity issues were identified.

The general practitioner is responsible for ensuring the patient receives education regarding their medical condition, proposed anticoagulant therapy, the target range, any effects and symptoms they may experience of over/under coagulation, and also potential effects on their anticoagulation control such as dietary impacts, lifestyle and medication interactions. Consent to treatment should be obtained at this stage and documented appropriately, on EMIS or treatment plan.

The general practitioner is required to explain to the patient the near patient testing system with regard to areas such as obtaining blood samples, process for dose increases or decreases and ongoing monitoring programme.

If on the first visit by the Registered Nurse, the patient appears to lack the capacity to understand the concept of the near patient testing service, the patient should be referred back to the general practitioner for consideration under the ‘Adults with incapacity (Scotland) act 2000’. A referral should be made to examine the suitability of the patient for inclusion in this service.

The Registered Nurse responsible for the patient should complete a “person-centred” assessment and care plan for near patient testing (see appendix 1). The ongoing nursing assessment of patients needs is undertaken and recorded in accordance with NMC guidance.

It is considered good practice on each visit to take a copy of the checklist recording sheet (see appendix 1) to consider and record any anti-coagulation problems the patient may be experiencing.

After carrying out the appropriate test, the Registered Nurse or delegated Health Care Support Worker will then relay the test result to the GP practice. This may be by telephone from the patient’s home; in person or in writing (in some areas, this takes the shape of a list of patients seen during a session).

Patients should be clearly identified using CHI number. The GP practice will then, (using this information) input into the decision support software (whichever system has been deemed appropriate for use in the practice) to determine the dosing and review advice. Thereafter the GP practice will record the result and dose to be taken by the patient in the GP IT system.

The GP or specifically trained support worker must then advise the patient accordingly. This could be in the form of a print-out of information and dosage dispensed by IT system; this can be given directly to the patient and will advise the patient or the patients’ carers of the dose to be taken. The GP or specifically trained support worker may chose to telephone the patient or appropriate carer directly with the information on dosage of medication.

Quality control

External quality control should be carried out monthly by community nursing staff. Lab- venous samples are selected and compared to the Coagucheck machine. Recorded and kept with each machine.

All communication and records should include the patient’s name, date of birth, Community Health Index (CHI), reason for anticoagulation therapy, duration of therapy, target range INR, and record within the appropriate documentation. (NHS Oral Anticoagulant Therapy Booklet (Yellow). This should be updated timeously.

A dosage scale for the individual patient which must be observed when titrating within those stipulated dosages.

Information that the patient has been informed and is in agreement with this treatment plan, this is recorded in the electronic GP record for community nurses to access. This information is also be recorded in the patient’s own self held record and nursing care plan.

Community Nursing Staff employed by NHS Ayrshire and Arran may carry out near patient testing providing the following conditions have been met:

• The nurse/caseload holder is currently registered with the NMC
• The nurse should be proficient and deemed competent by the Charge Nurse – District Nursing in the use of NPT equipment and processes, and knowledgeable in anticoagulation management and treatment.

Health Care Support Workers employed by NHS Ayrshire and Arran

• Following a clinical risk assessment by the Charge Nurse – District Nursing delegation to an appropriately trained Health Care Support Worker for the blood sampling element of the NPT service in the patient’s home may be considered. The Charge Nurse – District Nursing must undertake this delegation in line with NMC guidance on delegation, and ensure supervision of practice.

Equipment required

(depending on local system – minimal equipment to patient's home):

• INR coagulation recording equipment
• test strips in accordance with equipment– stored appropriately
• code chip if in accordance with equipment
• lancets – disposable
• gloves
• sharps disposal container
• cotton wool/gauze
• plasters
• cleaning materials for device – lint free cloth & warm water, alcohol wipes
• equipment operators manual
• appropriate documentation (e.g. anticoagulation check list)

Process

• All patient documents should include name, address, CHI and GP.
• Only devices that have had appropriate quality control procedures followed may be used for Near Patient.
• The staff member performing the test should use either use the checklist in the appendix or undertake a robust check for problems and record appropriately the following:
  
  • bleeding or thrombotic incidences
  • warfarin compliance and changes of medication
  • lifestyle changes, e.g. increase in alcohol consumption.
• Where applicable, the patients identifier CHI should be entered on the monitoring device prior to performing the test to allow reading to be saved accurately in the monitors memory.
• Perform blood test using the technique specified by the manufacturer of the device.
• Relay test result to GP practice in writing, or in person (HCSW) A Registered Nurse may telephone directly to the GP practice.
• GP practice will enter the result and communicate the dose and date for next test to the patient or designated carer (who has been deemed appropriate for the administration of the patients’ medication).
• Take venous sample if INR is under 1.5 or >5

Accountability for quality control checks should be agreed locally within each GP practice.

Internal Quality Control

This involves testing control reagents with known INRs in the device. If the result is within the expected range this gives a degree of confidence that the equipment is working accurately. The reagents should be available from the manufacturer for most devices.

Internal quality control using the reagents should be performed as stipulated by the manufacturer. If the result lies outwith the acceptable range the test is repeated. If the second quality control test is also outwith the desired range, the device will not be used and contact would be made with the manufacturer for guidance.

Some devices also has a number of additional internal quality control functions which include a check of the expiry date and lot information on the test strip, a check of the electrical components and functions each time the monitor is turned on. Full details may be found in the device manual.

External quality control

There is a national scheme for monitoring of the Coagucheck equipment which is called NEQAS. Practices may subscribe annually and the process involves the practice testing control samples in the Coagucheck device.

Related documents

NHS Ayrshire and Arran control of infection manual
NHS Ayrshire and Arran guideline for home blood glucose monitoring.

References

Baglin, T.P., Keeling, D.M&Watson, H.G. (2011) Guidelines on oral anticoagulation (warfarin) fourth edition. British Journal of Haematology 154, 31.

Royal Pharmaceutical Society, Professional guidance on the safe and secure handling of medicines (JAN 2019) Available from:
https://www.rpharms.com/recognition/setting-professional-standards/safe-and-secure-handling-of-medicines/professional-guidance-on-the-safe-and-secure-handling-of-medicines

Royal Pharmaceutical Society, Professional guidance on the administration of medicines in a healthcare setting (JAN 2019). Available from: 
https://www.rpharms.com/Portals/0/RPS%20document%20library/Open%20access/Professional%20standards/SSHM%20and%20Admin/Admin%20of%20Meds%20prof%20guidance.pdf?ver=2019-01-23-145026-567

Scottish Patient Safety Program (2015). Warfarin care bundle. Available from:
https://ihub.scot/media/1107/20150514-warfarin-bundle-measures-v1.pdf
https://ihub.scot/media/1068/2017-warfarin-bundle-rational.pdf

Care plan for near patient testing in community setting