NABL must evolve protocols for standardisation

Dr W V Lawate

This is with reference to the story ’NABL’s new accreditating standard effective from June’ in 16-31 March issue of Express Healthcare Management by Sapna Dogra. There would not be two opinions about the need of the services offered by Indian medical laboratories to be improved to international standards, in terms of facilities, human expertise, dependability of results and information friendly attitude towards patients.

It will be worthwhile to quote one incident in this regard. A hypertensive and hypercholesterol patient was tested for his lipid profile by a laboratory which was run by a doctor couple- both being MD in pathology.

The patient’s report suggested that his lipid profile was bad in every respect. Quite astonished and on his physician’s advice, he got himself tested in another well known laboratory. To his surprise, there was not a single red mark on any of the parameters. The physician advised a third laboratory checkup which came out comparable in results to the second laboratory.

The patient approached the first laboratory to discuss this discrepancy. The doctor in charge, initially did not admit about a possible mistake, but subsequently agreed to repeat the test exgratia and obtained results which were comparable to the second and the third laboratory.

Many laboratories do not approach NABL for accreditation because it is not mandatory and is also expensive. It is also a lengthy procedure besides the standards of NABL are difficult to achieve

Both the patient and his physician were greatly relieved that the drug treatment is on proper lines and is working satisfactorily. Eventually the first laboratory doctor, very reluctantly accepted his error and regretted. However, it was too late and the approach was obviously not convincing. The damage had already been done.

The first laboratory lost the patient permanently, who was their faithful customer for quite some years. Besides, the laboratory also sufferred from bad reputation as the story spread to other patients, physicians and the friends of the patient.

National Accreditation Board for Testing and Calibration of Laboratories (NABL) has come up with a new standard, ISO: 15189: 200, for evaluation of quality of work and competency of medical laboratories. This new standard will become effective in India from June 1, 2005.

As of now, about 40 medical laboratories across the country have been accredidated by NABL under earlier standard ISO: 17025:1999. These laboratories will have to upgrade to ISO:15189:2003 by June 30, 2005.

It is estimated that there are around a million clinical diagnostic laboratories in India, ranging from fully automated state-of-the-art establishments, whose services are solicited by overseas hospitals and doctors, to make-shift ill equipped structures. These may be merely collection centers, who draw samples and pass them on to other connected testing laboratories.

Out of the million laboratories, hardly 25,000 have a fair level of instrumentation and qualified staff. Presently, all that is required to start a clinical laboratory is a license from shops and establishment department of local authorities. It is said that in the state of Uttar Pradesh, even this is not required.

Many laboratories do not approach NABL for accreditation because it is not mandatory and is also expensive (about 1.5 lakh for the entire process), so also a lengthy procedure besides the standards of NABL are difficult to achieve. In this connection, it is noteworthy that not a single clinical laboratory of any government hospital is so far NABL accredited.

NABL itself is assessed by the Asia - Pacific Laboratory Accreditation Co-operation which in turn draws its authority from the International Laboratory Accreditation Co-operation.

There is an argument that NABL has not yet evolved it’s own country specific protocol for standardisation, be it instruments, reagents and equipment for calibration, non technical directions such as specified colours of paint on the walls of laboratories, air conditioning of all facilities, minuted management meetings, internal audit, feedback from customers and frequency of reviews.

It has been suggested that the whole accreditation process should cost not more then Rs 25,000 for a medium size laboratory and non-critical specifications should be diluted. These steps will help to attract more laboratories to the accreditation board.

The writer is a Mumbai-based consultant