‘Small labs find NABL procedures tedious and expensive’

The Rs 50,000-crore diagnostic industry is undergoing technological innovation. Advanced diagnostic kits are ensuring accuracy of tests, for which reports are made available on the net, on the very evening of the tests. With the emphasis on quality of the labs, accreditation is also gaining ground. Dr Sushil Shah, managing director, Metropolis Laboratory and president of Association of Practising Pathologists of India (APPI) and Dr Ajit Pendharkar, chief assessor of NABL and secretary of APPI, discuss issues related to the diagnostic industry and pathologists, in an interview with Rita Dutta.

Dr Sushil Shah	Dr Ajit Pendharkar

Dr Shah, few months back you had expressed reservations about joining any organisation. Why did you suddenly change your mind to become the president of APPI?

I accepted the position of the president of APPI, as I gradually realised that to bring out reforms and to make the Government listen to our demands, it is necessary to have a platform. The Government pays attention to the demands of an organisation, but not to an individual.

What are the issues that AAPI wants to take up in the future?

A pathological lab is the eye of a clinician. And hence we want the government to come out with a legislation that would stop mushrooming of labs with inadequate infrastructure and manned by untrained technicians.

The states of Maharashtra, Rajasthan, Tamil Nadu, Delhi and Karnataka are already working on this line. The commercialisation of the pathology business has reached such a state that pathologists are getting trained through correspondence courses.

It is crucial that a lab undergoes standard quality control to see whether its results are up to the mark. The reagents, the standards or the technicians can be at fault. However, it is unfortunate that there is no accredited quality control agency in the country. Hence AAPI is planning to conduct workshops for quality control.

Though we see an increased awareness about accreditation of labs, why is it that labs are preferring ISO to NABL?

That is because, ISO 9000 accreditation is easier to get than National Accreditation Board for Testing and Calibration Laboratories (NABL). While for ISO 9000 the assessment is awarded after assessment of the infrastructure and procedures, NABL is extremely detailed.

The report to be prepared for NABL accreditation includes everything from standard operating procedures (SOPs), internal auditing, proficiency testing, feedback from patients and corrective action against it, how responsibilities of staff have been distributed, detailed documentation of the procedures, et al. Small labs find the procedures ‘tedious’ and expensive and hence do not apply for NABL.

Further, ISO has agents who market its accreditation and help the labs to prepare the report for accreditation. NABL has no such agents and leaves it to the individual lab to submit the quality manual report.

It is a fact that NABL, set up by the department of science and technology under the ministry of science and technology in 1998, has not picked up as much for the medical sector as for the industrial sector.

I would like to add that neither of the accreditation bodies emphasise on the quality of tests and its standards.

Then why can’t NABL modify its guidelines?

That is not possible as the NABL guidelines have been drafted by the International Laboratory Accreditation Council (ILAC).

Please comment on the Bombay Nursing Home Act which would supposedly lay guidelines for labs?

We don’t agree with the space earmarked for different categories of labs in the Bombay Nursing Home Act. More than 50 per cent of the existing labs would close down, if one has to go by the guidelines.

The guidelines is silent about the qualification of person who can man a lab. We want a lab to be supervised by an MD in pathology only.

The bureaucrats form an integral part of the licensing authority in the Act. What understanding do the bureaucrats have of private pathological labs? We want the government to include experienced pathologists from the private practice on the licensing panel.

How do you assess the changes in the pathology business over the past 15 years?

Fifteen years back patients expected that even the routine blood and urine tests be conducted by the pathologist himself. The pathologist used to spend a whole day collecting samples and diagnosing them.

Though this helped to develop a rapport between the patient and the doctor, on the flip side the pathologist was bogged down with unnecessary work. Now the routine tests are conducted by technicians.

We have also witnessed a revolution in the technology. As opposed to this, labs with unqualified technicians have mushroomed across the country.

Many labs hire part-time pathologists who visit for a few hours every day. Pathologists have cashed on this trend by hopping on to as many as five labs in a day. Is that a healthy trend?

It is okay for labs to have part time pathologists and for pathologists to visit different labs in a day. It is important that every lab has a full-time supervisor.

What is your opinion about the R&D in laboratory practice in India?

The R&D in private labs are good but that of government-run institutes are bad.

Piecemeal research is done in the government institutes, but no comprehensive study is being conducted. Whatever research is done at the government labs are being confined to the institute itself.

Which are the diagnostic tests that need more research?

We need to do more research for accurate tests for typhoid as the blood culture report does not always give cent per cent accurate result.

And also for Down’s Syndrome, as the blood test is only 80 per cent confirmatory. The rest depends on the clinical judgement of the doctor.