It was the wrong diagnosis by a private medical laboratory in Kottayam that led to an unneeded chemotherapy on an Alappuzha native a month ago. With an inquiry team set up by the Health Department now reportedly admitting the government’s limited role in regulating such labs, there is demand for an audit mechanism for them.
In the forefront of this argument are private lab owners themselves. Shaji Puzhakkool, State committee member of the Kerala Medical Laboratory Owners’ Association (KMLOA), says there is no system to monitor these units.
Trade licence
“All we need is a trade licence from the respective grama panchayat, municipality or city Corporation. There need not be any inspection from an authorised organisation to check the standards,” he told The Hindu . This was already mentioned in a survey done by the Directorate of Economics and Statistics of the State government in 2014. “...the Health Department continues to have zero control over private clinical laboratories functioning across the State,” it says. One of the major issues found during the survey was that technicians without proper qualifications were working in some labs. “Also there is a misconception that in the absence of enough qualified people in the industry a qualified supervisor is enough to guide the other staff in a laboratory, who are efficient but not qualified. This is a serious issue as doctors depend on the diagnosis from the labs.”
Sooraj Raveendran, consultant, National Accreditation Board for Testing and Calibration Technologies (NABL), points out that certification by an agency has not been mandatory for private labs so far. “There is no infection control or biosafety mechanism in most of the private labs. If they get the trade licence, there is no inspection thereafter too,” he points out. The survey claims that 93% of the total 4,168 private medical labs in the State have no accreditation or certification from any agencies. It also says that 26% of them do not perform any internal or external quality checking of the working capacity of the laboratory equipment and the quality of lab tests. Only 9% use biosafety cabinets. Mr. Puzhakkool, however, claims that there must be at least 20,000 to 25,000 such institutions across the State and those without any accreditation must be higher. As per the survey, their disposal of biomedical waste is also fraught with health hazards as 72% of the labs are still practising local disposal methods such as waste pit burial and open burning.
Mr. Puzhakkool says the Clinical Establishments (Registration and Regulation) Act could be a step in the right direction. The labs have now been asked to register and get a provisional licence.
