Accreditation requirement of laboratory medicine in India

Abstract

In our country it is generally believed that over one hundred thousand medical testing laboratories are functioning at various capacities providing diagnostic services to clinical decisions to be made for treatment protocol. India is also one of the destinations for the health tourism for rest of the world. One of the major requirements for health tourism is the accreditation status of hospitals and labs. It is unfortunate that less than 200 laboratories in India are accredited for management and technical requirement complied as per the International standard and few are certified under ISO 90012000 for their Quality Management System (QMS). The existence of most of unaccredited or uncertified the labs all over the country do not have any legal identity except for the fact they are only registered under shops and establishment act. It is also found that very few labs are managed by experts in the field and majority of the laboratories are owned or supervised by unqualified personnel. With this kind of situation unique to all developing countries, quality laboratory services for reliable test results are lacking. Under these circumstances the chances of a healthy person becoming sick is very high and the chances of a sick person becoming health is very low. We need to reverse the existing situation in all developing countries through a Good Laboratory Practices (GLP) and accreditation of medical testing laboratories implemented as per the International standard ISO 15189:2007 addressing the quality and competence of medical testing laboratories.