Gujarat Notifies Minimum Standards for Path Labs on Par with Central Govt’s Notification

AHMEDABAD:
In a move to clarify desirable and essential human resources in all pathology laboratories in the state and improve quality of medical testing services, the Gujarat government has issued a notification setting minimum standards for pathology laboratories.
The notification issued by the state health and family welfare department on August 23, 2018 has classified path labs into three categories- basic composite (small), medium and advanced labs in line with Clinical Establishments (Central Government) Amendment Rules, 2018 which notified minimum standards for diagnostic labs.
The new rules empower laboratory technicians to run basic composite labs (small path labs) independently and sign medical reports. It has made presence of MBBS doctor in small labs desirable. For medium and advanced labs, a post graduate in pathology or biochemistry or medical biology is an essential qualification.
The path labs conducting routine biochemistry tests, hematology tests, basic medical microbiology & immunology tests like rapid test (point of care tests) for infection, urine routine examination and microscopy, hanging drop for vibrio cholerae, stool for ova, cyst have been classified as small scale labs.
It is learnt that there are more than 4000 path labs in Gujarat being run by lab technicians catering to a large section of population.
The Gujarat High Court in 2010 had barred lab technicians from running path labs independently and signing medical reports.
“Laboratory technicians being not pathologists cannot run any laboratory independently. They cannot directly give any report to any patient or any other individual, or to any institution or practicing doctor, without the authentication of the same by the pathologist registered with the Medical Council,” said High Court.
The Gujarat High Court order was upheld by the Supreme Court on December 12, 2017.
Buoyed by the apex court order, pathologists association had lodged FIR in many police stations against laboratories which were run by non pathologists. This has made situation worse in Gujarat having a significant number of path labs lacking pathologists.
To overcome this serious situation, the health department has come out with a circular notifying the human resources required in path labs which cannot have MCI registered pathologist and the list of medical tests which can be conducted by such labs.