The govt. has formulated new rules for pathological labs in the amended Clinical Establishments (Central Government) Amendment Rules, 2018 notified earlier this year. The rules have specified minimum standards of services and facilities for medical diagnostic labs or path labs.

These new rules have categorized diagnostic labs into types: Basic composite (small), medium and advanced. The scope of services, infrastructure, staffing, records, equipments including legal requirements have also been clearly defined for each type of lab.

What is of utmost importance to note in these rules is that while a minimum qualification of MD/DNB in Pathology and Biochemistry or Medical Microbiology or Laboratory Medicine or MBBS with PhD in any of the above mentioned subjects has been made an essential requirement for medium and advanced labs, no such qualification/s has been specified for small labs. An MBBS/MS has been mentioned only as ‘desirable’ but not mandatory.

This means that now small labs may quite possibly be run by non doctors.

The irony of the situation is that the rules for small labs go on to state that “whenever interpretation of lab results or opinion thereon are required, a registered MBBS medical practitioner is essential”. These small labs can therefore only report results as values but not give an interpretation or a clinical opinion.

So, who will interpret the lab report? Reading the values and interpreting them in context of the individual patient will now have to be done by the treating doctor. And, this will be another head in the consultation charges. Because a consultation charge is not just the fee for consultation alone. It also includes non treatment costs such as the interpretation of lab/x-ray reports, making patient summary, administrative charges etc.

If these rules stay as such, then this would increase the cost of care, which will have to be borne by the patients.

When doctors voice their opposition to such a move, the public criticizes doctors. But, the patient has a right to know if his/her lab report has been signed and interpreted by a qualified doctor. All labs must be supervised by a qualified doctor, be it MBBS/MD.

In the light of these new rules, it is for the public to decide if they accept these rules of the govt. or not.

 Dr KK Aggarwal

Padma Shri Awardee

Vice President CMAAO

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Immediate Past National President IMA