P A FrancisWednesday, October 11, 2017, 08:00 Hrs  [IST]

The Delhi High Court last month ruled that diagnostic laboratory reports of patients should be verified and certified by a pathologist registered with state medical council only and not by a lab technician as is being done by most labs in the country. Such technicians can perform the tests and note their technical analysis but to convert this data into a report signature of registered pathologist should be necessary. The Court made this observation on a petition moved by Association of Clinical Microbiologists and Biochemists against Medical Council of India’s stand on this issue. MCI had made its stand clear some time back that all lab reports should be signed or countersigned by persons registered with State Medical Councils. ACMB members are not eligible to get registered with MCI or state medical councils. The ACMB’s stand is that their members are also highly qualified and are engaged in laboratory testing. The work of conducting laboratory test and submitting reports is essentially a skilled task and members of the ACMB are amply qualified and it is not necessary that the test reports submitted by them need to be countersigned by a medical practitioner. But, as per the clause (c) of Section 15(2) Indian Medical Council Act, no person other than a duly qualified medical practitioner is entitled to sign any medical report. As per the norms laid by MCI, a registered medical practitioner having a post-graduate degree in pathology can only certify test reports.
India is reported to have over one lakh diagnostic and pathology labs offering these services across the country. And a large number of them are run by technicians with Diploma in Medical Laboratory Technology (DMLT) or equivalent qualifications. As many states have not adopted the Clinical Establishment Act, hospitals, nursing homes, path labs and other healthcare institutions are not strictly regulated resulting in poor quality of these services to patients. No periodic inspections are being carried out by the state health authorities to check the facilities. Absence of a specific set of rules to regulate and monitor this sector is responsible for the current state of affairs. Maharashtra Association of Practitioners in Pathology and Microbiology (MAPPM) recently urged state directorate of health services to conduct inspection of path labs in the state as it detected several illegal pathology laboratories operating in the state. According to an estimate, there are around 8,000 path labs operating in Maharashtra alone and out of that, around 4,000 labs are stated to be run by technicians with DMLT or similar qualifications. The situation is not different in most other states also considering the fact that health administration is generally weak in most parts of the country. As state governments are negligent in regulating diagnostic labs, the Centre had issued a notification pertaining to minimum standards for path labs to regulate quality of tests some time back. As per this notification, the path labs have been classified into three categories viz. basic, medium, and advanced. The classification has been made on the basis of number of employees, number of samples, infrastructure and medical equipments. Now, to get the maximum benefit to the patient community out of these government and judicial actions, all the state health departments should step in and act in a responsible manner.