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.
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.
Covid pandemic is a good lesson for human race to experience and understand the broken healthcare system across the globe. Communities have gone through a lot of panic, sense of despair, sadness, worries, increased stress levels due to uncertain future etc. Most of the people have suffered from psychological disorders, giving rise to mental health issues.
The virus has tested the global healthcare system’s preparedness to face crisis, disasters of this nature and its challenges associated in dealing with the situation. Pandemic/epidemics are becoming a frequent affair. It’s high time global health organisations learn from this pandemic and work towards rebuilding a robust healthcare system.
Communities did not have access to accurate, affordable testing which could throw accurate and reliable test results across the globe. No standard test methods were followed thus adding more chaos and confusion at the market place. Lack of standardisation often leads to conflict in the system. Glaring gaps in the medical testing space during this crisis time made International Organisation for Standardisation work towards developing s solution to address the market need.
As a result, experts on ISO’s technical committee for laboratory testing and in vitro diagnostic (IVD) test systems started working on international best-practice guidelines to assist medical testing laboratories.
The future technical specification ISO/TS 5798, Quality practice for detection of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) by nucleic acid amplification methodsby ISO will have detailed considerations for the design, development, verification, validation and implementation of analytical tests for detecting SARS-CoV-2 using nucleic acid amplification methods. It will include pre-examination and examination process steps for respiratory tract specimens as well as their relevant parameters.
The new technical specification intends to help medical laboratories make the best use of commercially available IVDs when testing for COVID-19 and develop their own tests, so that testing is more reliable and accurate. But consistency and accuracy of results are not just about the type of test used, they are also linked to the overall quality of the laboratory that undertakes the work. Having an internationally agreed level of competence means that results can be trusted.
They can then be shared and compared with counterparts overseas, which is an essential step to assure quality control in medical laboratory testing – for COVID-19 as well as any future pandemic.
Whether a laboratory develops its own test methods or incorporates ones that already exist, there is a lot to be considered and the task bequeathed to them is great. Apart from the general risks of contamination, inadequate equipment or failings in processes that must be rigorously managed, the procedures and tools required for each test can potentially differ.
So how do laboratories demonstrate their competence in a way that is irrefutable?
Role of Conformity Assessment :
Labs demonstrate their testing competency, accuracy through implementing internationally accepted management systems standards and the validation happens through a process called through a system of conformity assessment. Being accredited to a recognized International Standard is a way that laboratories can show that they are competent.
At a time when the accuracy of tests for diseases such as COVID-19 is proving less than perfect, ensuring that laboratories have the highest level of competence is more important than ever. The lengths the industry goes to, with this multi-layered system of international validation, is extremely reassuring as it can help to establish agreed levels of competence and instill trust and confidence in their results. A rare source of comfort in such uncertain times, and one that will prepare us for any new pathogens.
Medical Testing Labs across the world have been implementing ISO 9001 Std , ISO 15189:2012 Std, Minimum Standards which are defined in many countries in the last few years to demonstrate their competency in managing the running of the labs.
QMS is the “secret in the ISO accreditation sauce.”
says Dark Daily Report from USA. That is because the quality management system, once properly implemented by a clinical laboratory or pathology group, provides the foundation for ongoing improvement across every functional area of the organization. All employees in a medical lab accredited to ISO 15189 typically get training in the QMS.
Considering the severity of the pandemic, it’s hightime IAF has published a Global Registry of ISO 9001:2015 Certified, ISO 15189:2012 Accredited Medical Testing Labs to evaluate the effectiveness of the medical labs quality testing infrastructure.
Since ILAC and IAF are getting merged, IAF can take up this responsibility. ISO should infact study the volume of certified, accredited medical labs before releasing any new standards without understanding the ground realities.
Many countries have announced Minimum Standards for Medical Labs in the last few years and WHO has been strongly advocating creating of National Minimal Standards for Medical Testing Labs.
If one considers the Indian scenario, we hardly have 2000 labs which are accredited to ISO 15189 and out of this, around 700-800 labs are accredited during this last one year alone to conduct Covid Testing. In a country like ours which has a close to 1-1.5 lacs medical labs (estimate only as there is no data, registry available in the country), only 1000 medical labs are accredited till last year. NABL took 10 years to cross 100 accredited labs number and took 20 years to cross 1000 accredited labs mark.
Global story on medical labs accreditation is no better. USA has 2 lacs clinical labs and very small fraction are accredited. Same scenario everywhere. So before launching any new standard, its time for ISO and IAF work together and come out with a Minimum Quality Standard that assures Quality and Accurate testing across the globe before any future pandemic strikes us again !
Our Value Added Experience :
Value Added, in its 3 decades of Mgmt Consulting experiences, has worked closely with 300-400 medical testing labs of all sizes in the last 2 decades guiding them to implement requirements related to various Certifications, Accreditations and has been the maturity level of the labs in implementing the accreditation requirements.
When the National Accreditation body, with more than 20 yrs existence, couldn’t inspire the mkt place ecosystem to adopt Certifications or Accreditations is an clear indication that this sector requires a Quality framework of different spec and ISO 15189 has failed to make an impact at the market place.
Value Added Team has closely worked with growth stage labs in seeking accreditation for Molecular Testing scope during covid times. We knew how challenging it was to make labs implement the basic QMS at the shortest time possible. Many managed to qualify for Accreditation as Board was granting accreditation on emergency basis.
We have the first hand experience of driving implementation of Medical Labs QMS under various programs. We have also rolled out a Remote Assessment Tool Kit to help the labs gradually transition towards strong internal implementation before taking up any external assessment by third party agencies. This should be the way forward for medical labs in the country to embrace QUALITY. Accreditation can never be the mandate for all Labs but Quality is. First step towards this journey is to adapt, adopt Minimum Standards in the country.
Medical Travel Programs Webinar on February 11th | 6:30 PM IST
The Global Healthcare Accreditation (GHA) Program and the Quality & Accreditation Institute (QAI) have launched a joint accreditation program for hospitals and clinics in India serving medical travel patients. The goal of the partnership is to leverage each organization’s strengths to better serve healthcare providers in India seeking to enhance medical traveler patient experience and business performance.
GHA and QAI are pleased to present the first joint webinar to the healthcare industry on Medical Travel Programs.
About the Program
Building Patient Trust Through Accreditation & Certification for Medical Travel Programs
Trust is going to be a major factor as hospitals and clinics around the world begin to reopen for medical travel patients or increase operations. Research suggests consumers will turn to trusted sources as safety increasingly becomes a brand differentiator. Has your organization implemented protocols to keep patients safe during travel and treatment? Are you communicating these effectively? How do you ensure a high-quality medical travel experience to patients seeking treatments in India including pre and post treatment?
Program Details :
Date & Time – February 11th from 6:30 pm – 8:00 pm IST
NABH Notification for Medical Imaging Services – 2nd Edition Migration Plan
For Medical Imaging Services (MIS) NABH will start conducting assessments as per 2nd Edition standard from 01st February 2021 onwards and no fresh or renewal application will be accepted as per 1st Edition standard after 01st January 2021.
The MIS centres which are accredited (either fresh or renewal) as per 1st Edition before 31st January 2021 will be required to upgrade their centres to the MIS 2nd Edition before 30th June 2021 and submit compliance report to NABH in the form of an internal audit report based on MIS 2nd edition. The actual implementation of the 2nd edition by the center will be verified by NABH during the next due assessment.
NABH has organised a Program on Implementation (POI) on NABH Accredittaion Standrds for Medical Imaging Services (2nd Edition) on February 27 & 28, 2021.
Revised Migration plan for transition of Applicant/Accredited MIS Centres towards the implementation of NABH Accreditation Standards for Medical Imaging Services – 2nd Edition in their respective centres is being issued by NABH and the document can be downloaded from the link below :
In reference to the initiative of Quality Connect- Learning with NABH, NABH invites from the Healthcare Organizations, the best practices followed by them in the form of case studies/posters/articles etc on the International Patient Safety Goals (IPSGs).
The best case studies/ posters/articles etc will be featured in the upcoming issue of Quality Connect Newsletter & the winners will be awarded in the form of free certificate courses of NABH.
Healthcare organsations are requested to kindly send their entries by 15th January 2021 by mail to firstname.lastname@example.org