The Pharmaceutical Journal
Vol 270 No 7241 p416
22 March 2003

Society summary

New practice guidance on testing body fluids published

The Royal Pharmaceutical Society has produced an updated and expanded document giving practice guidance on the testing of body fluids. The document replaces guidance that was formerly given in 'Medicines, ethics and practice: a guide for pharmacists' but was omitted from the current edition because of the revision.

Among the changes in the revised guidance is a requirement that a pharmacy that tests body fluids must have a designated area with suitable facilities for performing the tests and for storing and disposing of clinical waste. The previous guidance required only that the specimen collection and the test itself should not be undertaken within the dispensary or anywhere where food or drink is consumed.

The new guidance also says that there should be a designated consultation area in which to provide counselling for the patient. The previous guidance just specified "an appropriate area" for counselling.

A paragraph on obtaining patient consent has been expanded to specify that the consent must be in writing. It says that valid consent requires the patient to have a broad understanding of the nature and purpose of the test procedure and any significant risk involved in having or not having the test. The person seeking consent must have sufficient knowledge of the test procedure to provide any information the patient may require. Further specific consent must be sought if surplus body fluid might be used for any other purpose, such as research or laboratory quality control.

Expanded guidance on safety measures includes a range of risk minimisation procedures relevant to the requirements of the Control of Substances Hazardous to Health Regulations 1999. A paragraph on the segregation, storage, transport and treatment of clinical waste has been greatly expanded to take account of waste disposal legislation. It explains how waste is categorised according to the main hazard it presents, with body fluids in one group, syringes and sharps in a second group, and urine and urine containers in another group. For each group, the guidance explains the requirements affecting packaging, storage, labelling, transport and disposal.

A revised paragraph on the disclosure of test results makes it clear that the results must be in writing and given only to the patient or to an agent who has the patient's written authorisation. Counselling on the results, implications and limitations of the test is now a general requirement rather than being needed only when the results are not within the desirable range. Those providing information and counselling must be trained in these skills.

The guidance repeats previous advice that test results should where appropriate be copied to the patient's general practitioner with the patient's permission. But it now adds that patients who withhold permission should be advised to seek medical advice as appropriate, taking the results with them.

The guidance can be downloaded as a six-page PDF file from the practice section of the Society's website. Pharmacists without access to the internet can obtain copies of the revised guidance from Lorraine Fearon, Practice Division, Royal Pharmaceutical Society, 1 Lambeth High Street, London SE1 7JN (tel 020 7572 2409; e-mail lfearon@rpsgb.org.uk).

The guidance on the testing of body fluids is one of a number of guidance documents currently being revised by the Society's practice division. Most of the revisions have now been published, but revised guidance on cholesterol testing and on dealing with clinical trials is still to come.