Implementation of the draft regulations under the Kerala Clinical Establishment Act could lead to the closure of a majority of private medical laboratories, according to the State committee of Medical Laboratory Owners Association.
While the Act was passed in 2018, the registration of health-care facilities began in 2019. Sub committees established under the Act had submitted reports on the draft regulations that would govern the functioning of the establishments.
“Apart from what was initially laid down by the Act, several other regulations have now been suggested by the sub committees. The minimum space requirement for the smallest lab under the regulations is 500 square feet. But expansion is not feasible for most labs. Besides, some labs are staffed just by one person. Now, according to these regulations at least one person who has studied under the Directorate of Medical Education would have to be employed at the lab. New instruments, including hematology analyzers and binocular microscopes are to be set up even in the smaller basic labs. Despite these instruments, only basic tests for sugar, creatinine, cholesterol, and urea can be done at the basic labs as per the regulations,” said Bejoy V. Thomas, secretary of the association.
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A discussion with the association was necessary before these draft regulations were enforced, he said. Otherwise, it could lead to the closure of several establishments and widespread job losses in the sector, he said.