Karnataka, the first State in the country to announce the guidelines for running private diagnostic laboratories, has suddenly slowed down in this regard. The directorate of health and family services in the State has made a demand to the State government to regularize the mechanism in all districts in the state where technical training for labs is provided and a licensing authority along with licensing conditions for running a pathology laboratory is undertaken.

According to informed sources, there is an inordinate delay on the part of the directorate of health and family welfare, which has not yet called for a panel of experts in pathology for discussions with the State government. "It is a basic requirement to have a qualified doctor to head diagnostic labs," Dr. K M Srinivasa Gowda, registrar, Rajiv Gandhi University Health Sciences and former professor & head of the pathology department, Kempegowda Institute of Medical Sciences (KIMS) told pharmabiz.com

In 1998, the Karnataka Chapter of the Indian Association of Pathologists and Microbiologists (KCIAPM) ordered the State government to evolve a mechanism to improve the medical diagnostics laboratories, which have mushroomed in Karnataka.

KCIAPM is ready to sit with the state government as well as other bodies to evolve a policy. "Presently, there are no guidelines and any one can start a laboratory as even the Medical Council of India (MCI) does not look into the quality of diagnostic clinics", he informed.

The Central government has already framed a draft for the rules in this regard in 2000. This draft can be used as a template by the government of Karnataka to initiate the action further, averred Dr. Gowda who regretted that nothing so far has been done.

There are over one lakh pathology laboratories in the private sector in Karnataka and Bangalore alone there are 20,000 units. There are only a handful of big names like Elbit Diagnostics Limited, Anand Laboratories Limited, Medinova Diagnostics, Jubilee Roentgen Health Diagnostics Limited, etc. The need for guidelines was felt long ago, as several diagnostic labs that had come up in Karnataka run or owned by qualified pathologists or microbiologists.

The KCIAPM had suggested that a qualified doctor who should at least be a diploma holder in pathology or preferably a MD in pathology to head a diagnostic lab. The diagnostic labs should meet the prescribed standards regarding the space, facilities and trained personnel and should compulsorily be a part of the quality control programme.

The need to form guidelines had arisen, partly due to the fact that a large number of institutes were now permitted to offer courses in medical laboratory technology, following the State government's announcement for job-oriented courses in this area. Many of these institutes were not attached to any of the hospitals explained Dr. Gowda. The trainees who passed out from these institutes had no practical experience and did not even know how to draw out blood the basic and critical requirement in clinical pathology. "Such technicians man many medical labs in Karnataka and pose a serious threat as medical practitioners rely on the results of these labs for the treatment of the patient.

There was no quality control in over 70 percent of the labs in the State which added the fear of transmission of AIDS, hepatitis-B from the diagnostic labs.

The focus of the policy must be on qualification and quality control in medical diagnostics. At the 19 medical college hospitals in the State, the All India Institute of Medical Sciences (AIIMS) sends unmarked blood smears and samples regularly to theses college hospital laboratories for a report and the diagnostic labs in Karnataka are rated to be among the top ten in the country.

Diagnostic labs in Bangalore could be one among the best in the country, observed Dr. Gowda.

The most critical aspect is the shortage of qualified personnel and the colleges more so in the diploma segment to update the teaching and practical exposure. The problems are rampant in the private nursing home labs where inspite of qualifications, the technician is inexperienced to handle the patient for drawing blood.

There are also complaints by patients on the variation in readings in hematology or clinical pathology. Dr. Gowda attributes it to the conventional method of diagnosis where there could be a difference in the quality of solutions used for the tests. But with the wide range of automated analysers, the problem cannot exist if a diagnostic lab is well equipped. In Bangalore out of the 20,000 medical diagnostic centres only 45 percent have the automated analysers.

The other vital issue to be tackled the high cost of diagnosis. Despite the state of the art equipment, the cost of diagnosis has not come down instead gone up by 150 percent in the last one decade, informed Dr. Gowda.