The pathological shops that ring-fence every major hospital in the country could be in for a wake-up call. So far, except for a few national chains, one lakh such shops have needed only a registration from the state governments, under the Shops & Establishments Act, to function. This meant their accountability was no more than that of a grocery store or barbershop for the services they provide to their customers.
But that picture is about to change. Recognising the mushrooming path labs as the weak underbelly of the Indian medical sector, Quality Council of India (QCI) has roped in four state governments, Madhya Pradesh, Kerala, Tamil Nadu and Gujarat to block recognition to a path lab as a legal entity unless it is registered with QCI and meets the international accreditation standard of ISO 15189. This ISO standard is specially designed for the medical laboratories by the National Accreditation Board for Testing and Calibration Laboratories, an autonomous body under the department of science & technology.
This development is significant as only a handful of national chains are properly registered under the Clinical Establishment Act. QCI has signed memoranda of understanding with these four state governments, which means the existing labs in these states will get a year to comply, from the date of declaration.
According to industry estimates, the Rs 8,000-crore path lab business is growing at 20% annually. Of the one lakh diagnostic labs spread across the country, less than 200 are registered with QCI. Since health is a state subject, QCI will have to sign 28 such MoUs to cover all states to usher in accreditation standards pan-India.
According to T Venkatesh, principal advisor, QCI, ?We are in talks with Orissa and UP, among other states, to sign the MoU. It is for the benefit of the industry (path labs), which can assure and promise quality to consumers.??
For a lab, getting the certification could cost less than 10% of its annual turnover. QCI has approved several authorised agencies to carry out inspections for conformity to standards in quality control, manpower, equipment and machinery at these labs.
Accreditation will benefit the labs, too. It will mitigate the expected rise in the litigation costs in the near future that the labs are sure to face as more aware patients take them to courts on issues of quality.
Secretary-general of QCI, Giridhar Gyani, told FE that the organisation is in talks with various large corporate houses to make quality accreditation a prerequisite for hospitals and path labs willing to be empanelled for providing medical benefits to their respective employees. Such a deal has apparently been recently struck with Bengaluru-based Mindtree Consulting Pvt Ltd.
The strategy of using large corporate houses as intermediaries will reinforce voluntary adoption of accreditation by path labs and hospitals, as corporate houses contribute significantly to their revenues.