The central government has notified the Clinical Establishments (Central Government) Amendment Rules, 2018, setting minimum standards for diagnostic labs.
Based on the scope of services offered, the notification classifies diagnostic labs into three categories: basic composite (small), medium and advanced labs.
Post graduation in pathology or biochemistry or medical biology is an essential qualification for medium and advanced labs. As far as small labs are concerned, there is no minimum qualification.
The path labs conducting routine tests biochemistry, haematology such as basic medical microbiology and immunology tests like rapid test (point of care tests) for infection, urine routine examination and microscopy, hanging drop for vibrio cholerae and the stool for ova, cyst have been classified as small-scale labs in the amended Rules.
For running a small diagnostic lab, a pathology degree in medicine or surgery from a recognised university is desirable.
No doctor is essential to run small pathological labs, as per the new amendment of the Clinical Establishment Act, 2010.
The new notification seems to be contrary to the Supreme Court order on December 12, 2017, which clearly stated that laboratory reports can be countersigned only by a registered medical practitioner with a postgraduate qualification in pathology.
Medium labs are those that provide additional tests such as hormone bioassay, tumour markers, plasma protein electrophoresis, coagulation assay, PAP smear, fine-needle aspiration cytology (FNAC), sputum and CSF cytology and certain microbiology and immunology tests, including serological tests for viruses, bacteria, fungi, parasites and cultural sensitivity.
Advanced labs, according to the new rules, handle tests like coagulation profile, drug monitoring and toxicology assay, molecular genetics, tests for detection of inborn errors of metabolism, other haematology tests, histopathology examination, molecular genetics, immuno cytochemistry, biological fluid cytology, ultrasound or CT examination, FNAC and immunohisto-chemistry. Also included here are culture sensitivity tests for viruses, real-time polymerase chain reaction (RTPCR) tests and tissue diagnosis test for infectious diseases.