Regulations or Accreditations ??? – beginning of a new conundrum
Medical Labs are undoubtedly an important part of the health ecosystem in any country but in India, like many other sectors related to health and safety, they have remained largely unregulated and therefore lacking assurance of quality and reliability.
The Clinical Establishments Act, 2010 intended to fill this gap but unfortunately only 11 states and almost all union territories have adopted the Act till now and from all accounts none has enforced the minimum standards prescribed under it. Therefore, there is not even data on how many medical labs are operating in the country much less any measure of their quality. The role of medical labs came into sharper focus as covid pandemic set in and India scrambled to develop covid testing facilities.The question begs an answer not only in relation to covid testing but for the larger issue of assuring quality of medical labs in general in the country.
Read the informative post by Mr Anil Jauhri, International Conformity Assessment Expert about Medical Labs and whether they need Regulations or Accreditations in the country .
Virtual Training on Pharmacovigilance for NABH Accredited Hospitals was conducted by IPC – Indian Pharmacopoeia Commission , recently to create an awareness on Pharmacovigilance and Reporting of adverse drug reactions (ADRs).This write up prepared is based on the training given by IPC Team and various experts like Dr. Jai Prakash Officer-in-Charge, PvPI, Mr Prashant Paschal, Assistant Director NABHQCI New Delhi, Dr. Vandana Roy AMC Coordinator MAMC-New Delhi, Dr. Rahul Shukla AMC Coordinator Yashoda Super Speciality Hospital, Kaushambi, Ghaziabad and my own search from various sources.
Pharmaceutical medicines are designed to cure, prevent or treat diseases; however, no medicine is without side effects and there are also risks particularly adverse drug reactions (ADRs) which can cause serious harm to patients.
It is been reported that adverse drug reactions (ADRs) are poorly reported in developing country including India. It is estimated that only 2-4% of adverse drug reactions (ADRs) are reported and only 10% of serious adverse drug reactions are reported world wide.
Pharmacovigilance (PV) plays a key role in the healthcare system through assessment, monitoring and discovery of interactions amongst drugs and their effects in human and helps in to reduce the harm to future patients.
What is ADR:
The World Health Organization defines an ADR as “any response to a drug which is noxious and unintended, and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function.”
In addition to Drugs the vaccines, Medical Devices, Biosimilars, Diagnostic Agents are considered for ADR.
Classification of ADR:
Adverse drug reactions are classified into six types (with mnemonics):
Type A :dose-related (Augmented), Type B : non-dose-related (Bizarre), Type C : dose-related and time-related (Chronic), Type D : time-related (Delayed), Type E :withdrawal (End of use), Type F : failure of therapy (Failure).
A simple and common method of classifying ADRs is to divide them into two types – Type A and Type B. This is also known as the Rawlins–Thompson classification.
Patients taking medication from specific classes like –
Anti diabetics and Hypoglycemic Agents
Reporting of ADR:
All healthcare professionals (clinicians, dentists, pharmacists, nurses) and patient/consumers can report ADRs to National Coordination Centre (NCC) or Adverse Drug Reaction Monitoring Centres (AMC).There are around 34 AMC centers in India. The pharmaceutical companies can also send individual case safety reports for their product to NCC.
Suspected ADR reporting forms for healthcare professionals and consumers are available on the website of IPC to report ADR. To remove language barrier in ADR reporting, the consumer reporting form are made available in 10 vernacular languages (Hindi, Tamil, Telugu, Kannada, Bengali, Gujarati, Assamese, Marathi, Oriya, and Malayalam). ADRs can be also reported via PvPI helpline number (18001803024) on weekdays from 9:00 am to 5:30 pm.The mobile Android application for ADR reporting has also been made available to the public.
There are many methods to analyze the ADR the most acceptable method is The WHO-UMC causality criteria.
The WHO-UMC causality criteria [WHO].
Conditions (all conditions need to be complied with for each causality criterion)
Event/laboratory test abnormality with plausible time relationship to intake of a drug Cannot be explained by disease or other drugs Response to withdrawal plausible Event definitive pharmacologically or phenomenologically Rechallenge satisfactory, if necessary
Event or laboratory test abnormality, with reasonable time relationship to drug intake Unlikely to be attributed to disease or other drugs Response to withdrawal clinically reasonable Rechallenge not required
Event or laboratory test abnormality, with reasonable time relationship to drug intake Could also be explained by disease or other drugs Information on drug withdrawal may be lacking or unclear
Event or laboratory test abnormality, with a time to drug intake that makes a relationship improbable Disease or other drugs provide plausible explanations
Event or laboratory test abnormality More data for proper assessment needed, or Additional data under examination
Report suggesting an adverse reaction Cannot be judged because information is insufficient or contradictory Data cannot be supplemented or verified
How to make the Hospital Adverse Drug Reaction Monitoring Centres (AMC):
The Hospital can send letter of intent to INDIAN PHARMACOPOEIA COMMISSION. National Coordination Centre – Pharmacovigilance Programme of India (NCC-PvPI),MINISTRY OF HEALTH & FAMILY WELFARE, GOVERNMENT OF INDIA SECTOR-23, RAJ NAGAR, GHAZIABAD- 201 002. Tel No: 0120- 2783392, 2783400, 2783401, Fax: 0120-2783311 e-mail: email@example.com, firstname.lastname@example.org, Web: www.ipc.gov.in
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.