Alarmed by rising cases of misdiagnosis and wrong diagnosis in the country which in turn leads to long-term complications, the Union health ministry is set to frame guidelines for standards of point of care test and collection centers. The guidelines will prescribe minimum standards for point of care testing, collection centers, standards of quality of testing kits, quality of above point of care testing and collection centers including training of personal performing these tests. It will be incorporated in Clinical Establishments (Central Government) Rules. At 11th meeting of National Council for Clinical Establishments chaired by Dr S Venkatesh, directorate general of health services (DGHS) on July 13, 2018, it was decided to set up a subcommittee under the chairpersonship of Dr Rajni Gaind, HOD Microbiology Safdarjung Hospital to prescribe guidelines on above laboratory related issues.
At the meet it was also decided that the collection centers shall be part of main laboratories and responsibility and accountability in respect of compliance of minimum standards by collection centers shall be of the parent laboratory. The collection centers will not be registered separately but as a component of the main laboratory. According to Dr Girdhar J. Gyani, Director General, Association of Healthcare Providers (India), Harvard study by Prof Jha showed 5.2 million medical errors are happening in India annually. Most of them occur due to misdiagnosis and wrong diagnosis of patients’ samples at pathology laboratories. Most of the pathology laboratories are run by laboratory technicians rather qualified pathologists, said Dr Prasad Kulkarni, member, executive council, Maharashtra Association of Practicing Pathologists and Microbiologists (MAPPM).
However, in May 2018, the ministry had come out with gazette notification in respect of minimum standards for medical diagnostic laboratories by amending Clinical Establishments (Central Government) Rules. There is hardly any law to regulate registration and standards of point of care test and collection centers, he said. Taking advantage of lack of regulation, unqualified professionals are involved in running collection centers hampering pre-analytical quality of samples. These collection centers don’t bother about maintaining requisite temperature while transporting samples to path labs. It affects quality of medical test reports, said Dr Kulkarni. A significant number of collection centers provides doorstep sample collection service but they hardly follow requisite process. The person deputed by them for collection of samples at patients’ doorstep is hardly trained, he added. Most of the collection centers of corporate path lab chains hardly comply with quality standards, he lamented. – PharmaBiz