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 .
Govt of India initiative for mapping of labs and testing infrastructure in the country
“PARAKH” portal is a Government of India initiative for mapping of laboratory infrastructure across the country on a unified network of laboratories. This is a step towards enhancing Ease of Doing Business. This portal incorporates all the NABL accredited and Government recognized laboratories in the country on a Geographic Information System. This is an interactive and user friendly system to search laboratories and avail laboratory services, based on various parameters a user may require.
DPIIT Team said this portal should help to reduce compliance burden of the labs.
This may be the first step towards strengthening National Laboratories Quality Infrastructure in the country.
As per the notification dated 22nd March 2021 (NABH/Notification/2021/1923), NABH has decided to further extend validity of Accreditation/Certification for a further period of 3 months (i.e. till 30.06.2021) or till the decision on the renewal application is taken byNABH, whichever is earlier.
The accredited/certified hospital ought to have completed the renewal process (paid the application fee, annual fee) and showed the willingness to undergo the assessment. Further, all the terms and conditions for eligibility of extension of validity mentioned in earlier issued notification dated 25th June, 2020 will apply.
The National Commission for Allied and Healthcare Professions Bill, 2020, was passed by Rajya Sabha recently. The bill had 110 recommendations, the government accepted 102 while six recommendations were accepted with slight modifications. Only two recommendations were not accepted.
The bill provides for regulation and maintenance of standards of education and services by allied and healthcare professionals, assessment of institutions, maintenance of a central register and state register and creation of a system to improve research and development and adoption of the latest scientific advancement.
The Bill defines ‘allied health professional’ as an associate, technician, or technologist trained to support the diagnosis and treatment of any illness, disease, injury, or impairment. Such a professional should have obtained a diploma or degree under this Bill. The duration of the degree /diploma should be at least 2,000 hours (over a period of two to four years).
Healthcare professional: A ‘healthcare professional’ includes a scientist, therapist, or any other professional who studies, advises, researches, supervises, or provides preventive, curative, rehabilitative, therapeutic, or promotional health services. Such a professional should have obtained a degree under this Bill. The duration of the degree should be at least 3,600 hours (over a period of three to six years).
Allied and healthcare professions: The Bill specifies certain categories of allied and healthcare professions as recognised categories. These are mentioned in the Schedule to the Bill and include life science professionals, trauma and burn care professionals, surgical and anaesthesia related technology professionals, physiotherapists, and nutrition science professionals. The central government may amend this Schedule after consultation with the National Commission for Allied & Healthcare Profession
Bill passed by the Rajyasabha is shared here for reference
Champion Services Sector Scheme for Medical Value Travel
Financial assistance in the form of Interest Subsidy for the establishment of AYUSH Super Specialty Hospitals/ Day Care Centres under Champion Services Sector Scheme for Medical Value Travel Ministry of AYUSH invited application in the prescribed format under Central Sector Scheme for establishment of AYUSH Super Specialty Hospitals/ Day Care Centres under Champion Services Sector Scheme for Medical value Travel for the year 2020-21 from the eligible private entrepreneurs registered under Societies Registration Act/ Trust/ Companies Act vide advertisement in leading news papers as well as through the website of Ministry of AYUSH. The last date of submitting applications was 08.03.2021. However, to give ample time to the investors, Ministry has extended the last date and now applications can be submitted in prescribed format up to 5:30 P.M. of 08.04.2021
The eligible private entrepreneurs may submit complete applications in prescribed format along with the required documents/ information to the Ministry of AYUSH. The detail of guidelines is available on the website of the Ministry of AYUSH and can be downloaded from here
Maharashtra State Innovation Society (MSInS), Govt. of Maharashtra is pleased to announce the launch of 2 key schemes to support startups in Maharashtra. Below are some details of these schemes:
Intellectual Property Rights Support Scheme: With the objective of spreading awareness and providing assistance for IPR (Intellectual Property Rights), this scheme aims to offer financial assistance of up to INR 2 Lakhs for a domestic patent application and up to INR 10 Lakhs for an international patent application, subject to 80% contribution by MSInS, on a reimbursement basis.
Under this scheme, DPIIT-recognized startups incorporated in Maharashtra, with a revenue of less than Rs. 1 crore and funding of less than INR 3 crores shall be eligible for domestic patent support. DPIIT-registered startups incorporated in Maharashtra, with a revenue of less than INR 5 crores and funding of less than INR 3 crores shall be eligible for international patent support. In case the startup has raised funds of more than INR 3 crores, MSInS shall support up to 50% of the total cost (instead of 80%). Apart from financial support, technical assistance (for example access to empaneled attorneys, etc.) will also be provided in this scheme.
Quality Testing and Certification Support Scheme for startups: Testing and certification of products for quality and assurance are an important and critical part of business for startups. However, these costs are high for startups in their formative years. The Scheme ensures that Government of Maharashtra will be reimbursing a part of quality testing costs incurred by Startups at NABL or BIS recognised labs.
Under this Scheme, DPIIT-recognized startups incorporated in Maharashtra, with a lifetime annual revenue in any financial year of less than INR 1 crore and funding of less than INR 3 crores shall be eligible for support of maximum up to INR 2 lakhs, subject to maximum 80% contribution by MSInS.
This Scheme shall increase the competence of startups in product development and will also help them become more competitive in the domestic and export markets.
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: firstname.lastname@example.org, email@example.com, 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.
Unauthorized and false claims of NABL Accreditation
NABL grants its accreditation to a Laboratory in the area of Testing (Medical and Other Categories) / Calibration / PT Providers / Reference Material Producers (as the case may be) for a specific period, specific scope, specific location and facility (subject to fulfilment of the requirements).
NABL has released an advisory and warning about unauthorised and false claims of NABL Accreditation at market place.
Panel Discussion – Possible Reasons & Way forward to take Preventive Measures
In view of the recently reported fire accidents in the country, (both in dedicated Covid Care Centers and other Hospitals, including Nursing Homes), an increasing amount of intolerance is visibly seen at the market place from public, various stakeholders towards rising fire accidents in healthcare facilities. Recent SC order in Dec 2020 called for immediate fire audit inspection of all covid hospitals in the country.
A Webinar to brainstorm about the reasons for increasing Fire Accidents in Hospitals in the form of panel discussion is taking place on Feb 9th 2021 from 3 – 5 pm.
Two rounds of Panel Discussions focussing on Possible Reasons & Way forward to take Preventive Measures is designed.
Session is organised by Consultants Consortium of Chennai and supported by NABH , AHPI, QAI, UL India and FOCUS to kick start series of deliberations.
Who should attend ?
Hospital Promoters, Medical Professionals, CEOs, COOs, Facility Incharges, Building Mainteanance Teams, Biomedical Teams, Operations teams, HVAC Teams, Utility maintenance teams , QA Teams, Safety Consultants and Experts, Hospital Planners, Designers, Medical Planners, Architects, Electrical Safety Engineers, Civil Engineers