NABL Comes Out With Entry Level Accreditation Scheme For Small Diagnostic Labs

Mumbai, 23 Nov 2018: In a bid to encourage diagnostic laboratories performing basic tests to adopt quality practices thus improving healthcare system at grassroot level in the country, the National Accreditation Board for Testing and Calibration Laboratories (NABL) has come out with entry level accreditation scheme for basic composite (small) medical laboratories.

It is estimated that there are about 1,00,000 diagnostic laboratories in India. Of them, 80 per cent are supposedly small, 18 per cent are medium and only 2 per cent of them are large sized. Most of the small laboratories are performing routine/basic testing and are situated in peripheral remote areas. They have mostly never opted for NABL accreditation because accreditation is not mandatory for clinical laboratories in India.

Of the estimated 1,00,000 diagnostic laboratories in India, only about 1000 are accredited by NABL. This is about 1 per cent of the total number of diagnostics laboratories in the country. 

To address gaps in quality practices of majority of laboratories, NABL has proposed to start voluntary scheme for accreditation of small diagnostic laboratories, stated a NABL release.

In order to bring maximum number of laboratories under this scheme, the criteria have been based on the requirements enlisted in gazette notification dated May 18, 2018 by Union health ministry to amend Clinical Establishments (Central Government) Rules, 2012. 

Interested laboratories will be required to submit application. The application will be accompanied by checklist filled-in by the laboratories themselves. 

The checklist covers scope of services provided by small laboratories such as routine biochemistry tests, hematology tests, medical microbiology & immunology tests. As per checklist, laboratories should have certain infrastructure facilities - public utilities, sample collection facility, specimen and slides preservation facility, counselling room for HIV (If HIV test is done), temperature control for specialized equipment, signage displaying name, qualification and registration number of laboratory in-charge, type of investigation and charges. 

Laboratories should have minimum medical diagnostic instruments, fire extinguisher, sterilization such as hot air oven or autoclave, grievance registration and disposal mechanism, process of calibration of equipment and reagents, patient Information and education mechanism. They should register under the provisions of Biomedical Waste Management Rules, 2016 with state or Union territories’ or Pollution Control Board. 

They should comply with infection control practices and waste segregation practices as per Bio Medical Waste Management Rules, 2016. They should maintain reports of all patients date wise and specialty wise, keep record of technicians working in laboratory. maintain quality control in the form of external quality assurance scheme or inter-laboratory comparison, as the case may be.

As per checklist, the minimum qualification of technical head of laboratory or specialist or authorized signatories is MBBS from a recognized university institution- which is desirable. It means laboratory technicians with DMLT or BSc, MLT or M.Sc Biochemistry or Microbiology qualification from a recognized university or institution who are essential in laboratories can sign medical report. 

The checklist will be finalised after reviewing comments from stakeholders. The last date for receiving comments from stakeholders is November 25, 2018.

On submission of application along with compiled checklist, a laboratory will be assessed by an expert from NABL. The entry level certificate will be issued to the laboratory with validity of two years. In addition to the initial assessment, NABL may conduct one or more unannounced assessment of the laboratory during two years of cycle. It is desired that the laboratories achieve accreditation as per ISO 15189 after these two years. However, the laboratories can continue with this scheme by applying for renewal and undergoing re-assessment. 

The scheme will not be covered under International Laboratory Accreditation Cooperation/Asia Pacific Laboratory Accreditation Cooperation/Mutual Recognition Arrangements. State health departments can adopt this for public health laboratories. The laboratories can switch to accreditation as per ISO 15189 at any point of time. However, the other way round is not allowed and laboratories once accredited will not be covered under this scheme.Pharmabiz