The Karnataka Government has issued a Notification under Section 41C and Section 87 of the Factories Act, 1948, listing down the criteria for recognizing and renewal of laboratories conducting medical examinations for workers employed in factories involved in hazardous factory processes within the State. As per the Notification, to be recognized as a laboratory for conducting medical examinations of workers in registered factories, the laboratory must meet the following requirements:

Key Highlights:

1. The laboratory must be accredited by NABL (National Accreditation Board for Laboratories);
2. The laboratory must be registered under the Karnataka Private Medical Establishments (KPME) Act;
3. The laboratory must have the facility to issue laboratory reports online and maintain them. These reports must be accessible to the worker, the factory, and the Department;
4. A qualified Pathologist must be in charge of the laboratory, and all reports must be countersigned by the Pathologist with the KMC (Karnataka Medical Council) registration number;
5. Applications for laboratory recognition/renewal must follow the format prescribed in Appendix A and include all required documentation, including trade licenses, staff qualifications, and NABL certifications;
6. The laboratory must be equipped to respond to medical emergencies during sample collection;
7. Laboratories are required to pay a non-refundable fee of Rs. 10,000 for registration and an additional Rs.10,000 for biennial renewal;
8. Consent from workers must be obtained before collecting samples;
9. Laboratories should ensure proper cold-chain storage and transportation facilities for samples and use NABL – compliant reagents.
10. The laboratory must display the certificates of qualification for Pathologists, Doctors, and Staffs at the premises and must make these available to Department officers upon request.

Source: Government of Karnataka

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