KOCHI: The Medical Laboratory Owners Association state committee has opposed the draft regulations of the Kerala Clinical Establishments (Registration and Regulation) Act, which is poised to bring in significant changes in the functioning of clinical labs and medical diagnostic centres across the state, over several practical reasons.
They point out that the proposed recommendations would result in the closure of small-scale labs and create a job loss of over a lakh technicians. The association also hinted that its implementation might force them to increase the rates of medical tests.
Although the Act was enacted in 2018, the government initiated the registration of laboratories only in 2019. The draft regulations for the functioning of these healthcare facilities submitted by the sub-committees of specialists to the Kerala Clinical Establishments Council were published for the public feedback on October 14.
"Once the regulations are implemented, small-scale labs in villages and towns will cease to exist. The three categories of laboratories will also lose their right to conduct several tests in the wake of certain regulations like space requirements and qualified physicians. As per the new draft prepared by the subcommittee, medical labs of level 2 and level 3 should appoint a 'Doctor of Medicine (MD) in Pathology' who will have to be paid around Rs 1 lakh in salary per month. Eventually, basic medical tests will become costly," said C Balachandran, president, State Committee of Medical Laboratory Owners Association (MLOA).
The association also clarified that they are open to ensuring standards in laboratories but the regulations should not be implemented without a discussion with the industry players. According to them, the registration of existing labs is already over and it is illegal to limit their authority to conduct certain tests solely based on the new regulations.
"If the government is moving ahead without considering the concerns of the owners, almost 95 per cent of the labs in the level-1 category will be forced to shut down. As per the draft, the minimum space requirement for the smallest lab is 500 square feet," said Hamsa Meladi, MLOA state committee member.
"The expansion is completely impractical for the existing labs as the number of tests has reduced drastically. Besides, advanced instruments have been made compulsory in basic labs and only tests like those for sugar level, creatinine, cholesterol and urea are permissible in these labs," Meladi added.
However, officials clarified that only the provisional registration process of all clinical establishments is currently under way and the new regulations are aimed at improving the quality. "We are approving the provisional registrations based on the verification of documents submitted by the establishment owners. These registrations have a validity of two years," said Dr Sanil Kumar, secretary, Kerala State Council for Clinical Establishments.
"The minimum standards including space requirements recommended by the committees for modern medicine, dental, clinical laboratories, diagnostic centres and Ayush centres will be considered at the time of giving permanent registration," Sanil added.
"The guidelines for appointing qualified persons was intended to avoid any sort of dilution in tests. Qualified pathologists are required in providing authentic reports and it will only be going to benefit the public in the long run. The draft regulations are currently published for month-long public feedback. We will publish the final notification only after considering the feedback from all stakeholders," he said.