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Home > Hospinews > Full Story

Delhi to bring out legislation for path labs

Rita Dutta - Mumbai

Labs to be registered and awarded grades

While experts show concern about the lack of standardization in pathological labs mushrooming in the country, Delhi ministry of health has drafted regulations for path labs for the capital city. The regulations state that all the path labs in the capital city have to be compulsorily registered with the state health ministry, said Dr A K Walia, minister of health, Delhi, while speaking to EHM.

The regulations have been formulated by a five-member committee comprising doctors, experts in path labs and bureaucrats over a period of six months. Delhi has around 1,500 laboratory centres.

The regulation is expected to standardize laboratory practice, as a pathological laboratory could be started sans any paper work, regulations and license. "Lab practice is perceived as any other money-minting business in the absence of any legislation. Registration of the labs would be the first step of regulation. Most of the labs, with unqualified technicians, equipment and infrastructure, can be monitored, by the simple process of registration," said Dr Arvind Lal, member of the drafting committee and managing director, Dr Lal’s Path Lab.

Depending on the range of tests that a lab conducts, the regulations have laid down requirements in terms of the space, equipment, infrastructure, and the minimum qualification of the practitioners. For instance, the regulations state that the lab technician should have a minimum qualification of two year diploma in lab practice from a reputed university. "There are some short courses which churn out lab technicians with in a few weeks. We want to stop that practice and have qualified lab technicians," said Dr Lal.

To improve the quality of detection, the regulation has laid down that every path lab should have a full time lab pathologist. "In most of the labs, there is no full time lab pathologist. Pathologists prefer hopping four to five labs in a single day, and just sign the report. This results in poor quality of detection," said Dr Walia.

The legislation would also include gradation of labs, depending on the tests that are conducted. The four gradations to be awarded are A, B, C and D, with A for lab conducting the most sophisticated tests to D for a small-time lab conducting simple routine tests, said Dr Walia.

A lab would only be registered when it fulfills all the criteria mentioned in the regulations. The modus operandi of registration would involve the lab first filling up the registration form, followed by inspection by a team of government officials to check the lab, before awarding the registration certificate.

"Regular checks would be conducted to see whether labs have registered themselves, and the labs which would fail to obtain registration would not be allowed to practice," said Dr Lal.

Emphasising on the importance of the legislation, Dr Lal said, "National Accreditation Board for Testing and Calibrating Laboratories (NABL) has given a thrust to accreditation, i.e excellence in lab practice, but it is not compulsory. The regulations would stop below par lab from practicing in the first place itself."

With Indian having about 20,000 path labs, now it needs to be seen, whether other states also brings out their legislation.
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