A pathological farce
In the absence of an authority exercising quality control, most path labs continue to have a field day.india Updated: Apr 30, 2006 02:39 IST
When Chandrani Das (name changed) went for a pregnancy test to a neighbourhood diagnostic lab in Malviya Nagar, the report not only confirmed her pregnancy but also stated that she was ‘weakly HIV positive’. Stunned by the results, she went in for a second test at a different pathology lab. Both the reports were negative this time: she was neither pregnant nor HIV-positive.
Instances of incorrect reports and results getting mixed up are not unheard of. In the absence of an authority exercising quality control, most path labs continue to have a field day.
“The lab I went to was out to make money even if it meant giving a wrong report. It’s criminal to wilfully mislead patients just to make profit. They charged Rs 2,500 for the pregnancy test and wanted me to give them more money to do confirmatory tests for HIV,” says Das. She got wise to their tricks just in time.
Apart from wrong diagnosis and overcharging, the Malviya Nagar lab erred on another count. This lab had no business testing a person for HIV status when all she asked for was a pregnancy test. Also, government norms clearly say that HIV test cannot be conducted without pre- aXnd post-test counselling.
Experts say it’s too much to expect neighbourhood path labs to follow government guidelines on HIV as most violate even the basic rules of sample collection.
Quality control is an alien concept in most of the path labs, as many of them are small set-ups started by technicians. All a person needs to set up a path lab is clearance in terms of land use norms and a pollution check concerning the disposal of biodegradable waste.
“Most of the path labs do not have any quality benchmarks as there are no stringent requirements. There is nobody monitoring the path labs mushrooming in the city. Most labs do not even have a permanent pathologist. At most, path labs can be governed by the Shops and Establishment Act,” says Janak Bajwa of SRL Ranbaxy, one of the accredited labs in Delhi.
According to National Accreditation Board for Testing and Calibration Laboratories (NABL), there are not more than 10 accredited diagnostic centres in the capital and only 60 across the country. “Accreditation is a voluntary procedure and we cannot force any lab to get accredited. NABL is not a regulatory body so we cannot randomly inspect labs. NABL strictly looks after quality control in labs and the technical competence of the laboratory,” explained Dr Sulabha Gupta, Director, NABL.
There are over 2,000 diagnostic laboratories in the Capital and industry estimates suggest that only 20 per cent of these labs manage to get a doctor on board. Most have a “hopping” pathologist, who ‘ghost-heads’ three to four labs, signing on blank test reports and leaving tests to be conducted by technicians.
Government hospitals and reputed private institutions often do not rely on lab reports from private path labs for treatment. “Since 70 per cent of the treatment depends on what the pathology report, we do not blindly accept the results from private path labs. If the clinical symptoms of the disease do not match the reports, we ask the patient to get the tests done again. This happens quite often,” says Dr Renu Saxena, Head of the Department of Haematology, All India Institute of Medical Sciences.
Experts suggest that asking for the certification is the only way of knowing how good or bad the path lab is. “If it an accredited lab, the technician would be qualified. As a layman, this is the only way one can find out if results from the lab can be trusted,” adds Dr Saxena.