Ethics in laboratory medicine

"Ethics in laboratory medicine" is the title of an Annexure given in ISO 15189: 2003 - an international standard published by ISO for Medical Laboratories - Particular Requirements for Quality and Competence. This informative requirement is the special feature of this standard. It is expected that medical laboratories shall adopt ethical practices in their working, shall not engage in practices restricted by law and shall uphold the reputation of their profession.

Need for following this standard by Indian medical laboratories has been felt for long. It has now been underscored by a series of three articles in a major newspaper of India (Times of India of November 21 & 22, 2005) - "Footpath lab, sick report: Health hazard in test tube"; "A booming Cottage Industry"; "Short on quality, high on risk, some path labs make you sick".

The general principle of health care ethics is that the patient's welfare is paramount. The Annexure points out that the professional personnel of a medical laboratory are bound by the ethical codes of their respective profession. The laboratory should treat all patients fairly and without discrimination, and not simply as a source of income.

Laboratory should maintain transparency in various activities performed by it which include collection of information, collection of primary samples, performance of examination, reporting of results, storage and retention of medical records and providing access to them, use of samples for examination purposes other than those requested, financial arrangements etc. This transparency, no doubt, should not infringe on the right of an individual patient to confidentiality of any information related to him. An unholy nexus is existing between medical laboratories with doctors who send them patients for a commission. This is highly unethical and should be avoided.

Doctors should refer their patients to those laboratories only which have a sound quality & competence management system in place. This system should meet or exceed the requirements of ISO 15189: 2003. Patients, on their part, should insist that their doctors refer them to only such a laboratory.