Planning or Upgrading an Anticoagulation Service

Setting up and running an anticoagulation clinic has major staffing and workload implications for a practice. Most practices experience an initial increase in workload as the numbers of patients seen in the clinic expands, and as staff members gain familiarity with the INR point of care testing equipment, dosing software and clinic protocols.

INR tests tend to be done more frequently during the early stages until staff become confident with the new technology. The use of computerised decision support software will allow a reliable increase in the average review period without reducing the quality of anticoagulation control, producing a net reduction in clinical workload over time.

When a practice performs INR estimations using point of care testing equipment it is, in effect, running as a pathology laboratory and it is therefore important that practice is aware of the relevant regulations and protocols.

Several major hospital laboratory services run schemes in which practices doing point of care testing are accredited by the hospital laboratory. The accreditation process varies locally but usually involves visits to the practice by hospital laboratory staff to oversee practice staff training, quality control and health and safety issues.

Training should be co-ordinated by the lead clinician for the clinic and may involve input from hospital coagulation departments, equipment manufacturers, and software suppliers as well as from the practice team itself.

Use of the point of care testing equipment and warfarin dosing software should be restricted to those staff that have completed the training.

The taking and testing of blood samples and the use of chemical reagents are activities with Health and Safety at Work implications which need to be evaluated and documented. Many of these may already be in place and documented in the case of practice nurses.

Hospital laboratories are required to undergo rigorous internal and external quality control to guarantee the accuracy and reliability of their results. It is important that practices undertaking point of care testing activities also apply similar standards of quality assurance.

Clinical audit has become an increasingly necessary part of all clinical activity and anticoagulation monitoring is no exception.

For example outcome events, such as thrombosis/embolism or bleeding, can be audited as can the actual INR result over time.

The currently preferred method of auditing INR results is that described by Rosendaal et al. in which the total amount of time that each patient has an INR within the therapeutic range is estimated. This is then calculated for the practice population as a whole and presented in terms of number of patient-days (or patient-years) within defined variations from the target INR.

The other recognised method ('point prevalence') is to measure the proportion of patients with INR results that are within their therapeutic range at any given time.

INRstar software produces these audits automatically, as well as other functions such as identifying patients who are overdue for an INR test.

Budgetary considerations include the costs of the necessary hardware - a coagulometer system and an initial supply of reagents/test cards/control reagents; clinical decision support software costs; staff training and administration.

The cost of coagulometers suitable for primary care use varies from a few hundred to several thousand pounds. CDSS systems likewise vary from around £100 to about £1000. The manufacturers may provide initial training as part of the purchase price of the equipment.

PCTs are now commissioning anticoagulation services from individual Practices, Practice-based commissioning groups or other providers on the basis of a local enhanced service (LES).

The details of contracts vary between PCTs but most are offered at level 4. This usually involves the practice testing the patients' blood using Near Patient Testing equipment to determine the INR value, calculating the warfarin dosage and review periods and performing regular audits and reports of anticoagulation control.

In more cases the provider would receive a fixed amount of reimbursement for each patient monitored.

Below is a list of costs you should calculate when planning you anticoagulation service:

• Reagent costs/test
• Nursing staff time (@ 4 tests/hour)
• Administration staff time
• Clinic accommodation (heating/light/cleaning etc) estimated
• Hospital accreditation/support
• NQAS*
• Software (INRstar)
• Stationary/postage

Costing the above items will enable you to calculate the estimated cost/test for 100 patients (1200 tests/year, i.e. 1 test per patient per month).

* Quality-control costs vary depending on how many control samples are sent to the local laboratory and whether the National Quality Control Scheme is utilised. You should be able to find out how much your local hospital laboratory charges for offering accreditation and on-going support per year.