Testing Strategy for Testing masses has undergone many changes in a dynamic manner since the beginning of the pandemic in the country.
ICMR has introduced Accreditation of the Med Testing Labs by NABL, as the eligibility criteria for Labs to conduct Testing .
Accessibility of Testing Labs to communities became the biggest stumbling block. Lots of calls, conversations across the markets asking for testing access. Urban markets stopped responding at some point, as the pressure became too much. Semi urban and rural markets didn’t have any access to testing at all.
Why are the labs not doing testing ? Why is it that the testing facilities are not accessible to all ? Who can actually do the Testing ? Where are Testing Labs ?
The above were the questions asked by many on daily basis.
I have written an article in the News Letter of Andhra Chamber of Commerce about ICMR’s announcement about allowing only Accredited Labs in the country to do testing, the current Quality Infrastructure of Medical Labs in the country which actually determines the eligibility of the labs to qualify for testing. Its this lack of Quality Testing Infrastructure in the country that has restricted Medical Labs to qualify for Covid 19 Testing criteria.
ICMR has recently relaxed the norms to increase accessibility of basic Covid screening Test to all and introduced Rapid Antigen Test (Screening Test) as well to reduce the dependence on RTPCR Testing. This will ensure that screening test is made available to all.
Sharing the article published in Andhra Chamber of Commerce’s News Bulletin here .
Medical Laboratories & the need to create a dedicated Laboratory Director Post / Designation to satisfy QMS requirement
Isn’t this becoming a HR issue
A Laboratory Professional from a client organization reached out to us seeking clarification on Lab Director’s role in Accreditation process. She was asked by the Management to redesignate Lab Director as Lab head in Accreditation documents and she wanted to know if its ok to do so as Accreditation norm is asking for Lab Director designation.
This has triggered an internal discussion at office and we were debating about the need to create / insist on Lab Director’s designation / role in labs seeking accreditation.
Medical Labs were obtaining National / International Certifications, Accreditations all these years and each program has its own spec. However, the global trend in the last few years has shifted towards introducing Minimum Standards for Medical Labs and many countries have rolled out the program. India too has rolled out the Minimum Stds for Labs as Regulatory spec under Clinical Establishments (Registration and Regulation) Act, 2010.
Let’s take the case of a Lab appointing a Lab Director as an accreditation norm and see what is listed out by various National , International Stds for this requirement.
We have the following popular programs for Medical Labs running in our country :
Minimum Standards mandated under CEA. Both NABL, QAI offer Certification programs under this scheme in the country.
Med Labs Accreditation Programs offered by NABL, CAP and QAI
Minimum Standards has mandated the Minimum qualification of Technical Head of Laboratory or Specialist or Authorized Signatories. Clearly defined spec on who should act as Technical head is mentioned. So any Certification program offered by NABL, QAI or any other body has to have the same spec in their Certification, Accreditation criteria as compliance to Minimum Standards is a Regulatory requirement.
ISO 9001:2015 Standard Clause 7 Support talks in general about Personnel competency, training needs etc. No other specification is listed as it’s a generic QMS Standard applicable for all businesses.
NABH Essential Standards for Medical Laboratories program talks about Personnel and its clearly mentioned about the Responsibility of Quality Manager & Technical Manager. But with respect to overall responsibility of the Laboratory Head, NABH Essential Standard for Medical Laboratories hasn’t mentioned anything much. So overall responsibility of Lab Head s not clear enough under this program.
QAI’s Recognition for Medical Laboratory Program, in Human Resources section – MBBS Doctor or MSc Pathology/Medical Microbiology/Medical Biochemistry are recognized qualification for Authorized Signatory. But there is no evidence of defining the overall responsibility of the laboratory head and the same isn’t clear in the QAI Recognition of Medical Laboratory Program either.
NABL’s Med Lab Accreditation Program mentions that Laboratory Director/ Head of Laboratory/ Technical Head (howsoever named), shall have the overall responsibility of Operations of the laboratory. Hence Lab Director’s Designation / Role is not mandatory. This is thee specific criteria document on NABL which is NABL 112. But the Standard for this program is ISO 15189:2012 which talks about the need to designate Laboratory Director.
CAP’s Laboratory Accreditation Program has a mandatory specification for Lab Director’s Designation and Role.
My Thoughts as a Lab QMS Consultant :
I’m going back to the question asked by the Lab Professional whether its mandatory to have Lab Director Role and Designation in the Accredited Lab.
As a Consultant in healthcare industry, I would say it’s a debatable topic. The requirement depends on the National, International Standards followed by the Med Labs.
I have listed out the personnel spec given by each Standard for Med Labs. Lab Director’s Designation is a hierarchy in the organogram and can’t be maintained by all Labs. Labs can specify their own designations as listed in the NABL 112 Criteria OR criteria.