Karnataka will be the first state in the country to announce a set of guidelines for running private diagnostic laboratories shortly. The state government's move comes in the wake of a representation made by the members of the Karnataka Chapter of the Indian Association of Pathologists and Microbiologists [KCIAPM] in mid- 1998, asking the state government to evolve a mechanism to improve the medical diagnostics laboratories mushrooming in Karnataka.

Dr. K M Srinivasa Gowda, professor & head of the pathology department of the Kempegowda Institute of Medical Sciences and former president of the KCIAPM told pharmabiz.com that there was an intimation from Dr. H Rangappa, assistant director [pathology], department of health and family welfare, on the state government's serious efforts towards having a licensing authority along with devising licensing conditions for running a pathology laboratory.

"We submitted the memorandum for a policy when Dr. H C Mahadevappa was the health minister exactly one and a half years ago. Now with Dr. A B Malakaraddy as the current minister for health and family welfare, the representation seemed to have seen the light of the day," he said.

The next step by the health and family welfare department would be to call the experts in pathology for a round of discussions with the state government.

Stressing the need for a proper policy, in this regard, Dr. Gowda said that the KCIAPM would be happy 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 does not look into the quality of diagnostic clinics", he informed.

The Department of Science and Technology has already made draft rules in this regard which can be used as a template by the government of Karnataka to initiate further action, averred Dr. Gowda.

In Karnataka, there are over one lakh private laboratories while in Bangalore alone there is 20,000 diagnostic units. There are only a handful of big names like Elbit Diagnostics Limited, Anand Laboratories Limited, Jubilee Roentgen Health Diagnostics Limited, etc. where diagnosis are accurate and dependable. The need for guidelines is a must as several diagnostic labs that have come up in Karnataka are not run or owned by qualified pathologists or microbiologists.

The KCIAPM has suggested that all diagnostic labs should be headed by a qualified doctor with a diploma in pathology or preferably a MD in pathology. 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.

Dr. Gowda said that the focus of the policy is qualification and quality control in the private medical diagnostics. The quality standards are better at the 19 medical college hospitals in the state as the All India Institute of Medical Sciences [AIMS] sends unmarked blood smears and samples regularly to theses college hospital laboratories for a report to judge their adherence to quality norms.

Delving further on the problems of diagnostic laboratory owners, Dr. Gowda observed that there was a shortage of qualified personnel and colleges. There is a lack of quality control in over 70 percent of the labs in the state and the risk of AIDS, Hepatitis-B and the like, such diagnostic labs could do incalculable harm.

From a patient's point of view, Dr. Gowda said that there were complaints on the variation in readings in haematology or clinical pathology. He 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 will not exist. In Bangalore, out of the 20,000 medical diagnostic centers, only 25 percent have automated analysers.

Another issue of vital importance is the high cost of diagnosis, which a patient has to pay. Despite the state of the art equipment, the cost of diagnosis has not come down. Instead the rates have gone up by 150 percent in the last decade.