Rules to improve standards of diagnostic centres

The Union health ministry has proposed to change the Clinical Establishment Rules to improve the quality of diagnostic centres that have mushroomed all over the country.

Last week, the ministry came out with a set of new draft rules that classifies the testing laboratories into three categories — basic composite, medium and advanced — and asked them to prepare themselves accordingly.  The draft rules will be finalised after 45 days, sources in the ministry said.

Laboratories processing up to 30 samples a day — mainly mobile units or field hospitals — will be considered as a basic composite, whereas the centres handling 30-100 samples would be considered medium.

Laboratories processing more than 100 samples will  come under the advanced category and will face the most stringent regulations.

The proposed rule also makes it mandatory for diagnostic centres to display their fee structure, including the type of the investigation and the charges, both for routine and special investigations.  Currently, investigation charges vary widely across laboratories.

According to industry estimates, there are more than one lakh diagnostic laboratories across the country, of which 70% offer pathology services, while the rest also provide radiology services like X-ray, ultrasound, and CT and MRI scans.

It is a fragmented market, dominated by the unorganised sector. While the basic laboratory should have at least one technician and one support staff; those in the medium category must have a minimum of two technicians.

The number of technical staff rises to four with two support staff for the centres falling in the advanced category.

The technical head of the basic laboratory has to be a MBBS doctor, while the person heading a medium category diagnostic centre may be a doctor with an MD degree or someone with a Diplomate of National Board (DNB) with a specialisation in a pathological field.

For an advanced centre, it will be essential to have a MD or DNB degree holder who has a diploma in clinical pathology with one year post-diploma experience.