Medical Testing Labs

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 .

Source : Healthcare Quality News Letter from QAI – http://www.qai.org.in/

Parakh-Unified Laboratory Network

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.

Source : DPIIT

Extension of Validity of NABH Certificate

NABH Notification

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 by NABH, 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.

Information Source : https://www.nabh.co/Important_links.aspx

Financial and Technical Assistance Schemes for Patent Filing and Quality Testing

Maharashtra Based Startups-CPY-CPY

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:

  1. 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.

  1. 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.

How to Apply

Applications are open now on first come first serve basis. Please visit MSInS website to check for eligibility and apply.  For any queries please email to team@msins.in or call on 02235543099

Registration

For more details, visit Maharashtra State Innovation Society @

https://www.msins.in/event-details/190

https://www.msins.in/

Pharmacovigilance in Hospitals

Reporting of Adverse Drug Reactions (ADRs) in Hospitals in India

Dr Srivatsan Bashyam, Principal Consultant

Email: srivatsan@valueadded.in

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 NABH QCI 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.

REACTIONTYPE A ‘AUGMENTED’TYPE B ‘BIZARRE’
Pharmacologically predictableYesNo
Dose-dependentYesNot clearly
IncidenceCommonUncommon
DetectionEarly in clinical developmentPost-licensing
MortalityLowHigh
ManagementReduce doseDiscontinue therapy

Who are at Risk of ADR :

  • Elderly

Patients taking medication from specific classes like –

  • Anti diabetics and Hypoglycemic Agents
  • Cardiovascular Drugs
  • Psychotropic Drugs
  • Anticonvulsants
  • Antineoplastic
  • Corticosteroids

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.

Analysis of ADR:

There are many methods to analyze the ADR the most acceptable method is The WHO-UMC causality criteria.

The WHO-UMC causality criteria [WHO].

CausalityConditions (all conditions need to be complied with for each causality criterion)
CertainEvent/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
ProbableEvent 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
PossibleEvent 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
UnlikelyEvent or laboratory test abnormality, with a time to drug intake that makes a relationship improbable
Disease or other drugs provide plausible explanations
Conditional/ unclassifiedEvent or laboratory test abnormality
More data for proper assessment needed, or
Additional data under examination
Unassessable/ unclassifiableReport 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: pvpi.ipc@gov.in, lab.ipc@gov.in, Web: www.ipc.gov.in

Laboratory Director Designation – ISO 15189 Standard Requirement

Designation of Lab Director, a QMS Specification, becoming a HR Issue in the Laboratory

Chithambaranathan Sivasubramonian, Associate Consultant

nathan@valueadded.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.
  • ISO 9001:2015 – Quality Management Systems Certification Program
  • Med Labs Certification Programs offered by NABH
  • 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.

When 80-90% of the Labs in the country belong to Small labs category, can all qualify for Certifications, Accreditations. An ideal case is for Small labs to opt for Minimum Standards as 1st step towards the Quality journey before migrating to Certifications, Accreditations Programs. Compliance to Min Stds is also mandatory as it’s a Regulatory requirement.

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.

NABL Medical (Entry Level) Testing Labs Program

Criteria and Procedure for NABL M(EL)T Labs Program

NABL Medical (Entry Level) Testing Laboratories {NABL M(EL)T Lab} Program is an entry
level program for medical laboratory under which laboratory shall be recognized for basic
routine tests based on the satisfactory proficiency testing (PT) performance.

This scheme is:
i. not covered under Asia Pacific Accreditation Co-operation (APAC) & International
Laboratory Accreditation Co-operation (ILAC) MRA.
ii. valid for one cycle of three years.
iii. applicable only for basic routine tests as mentioned in Annexure A.
iv. based on satisfactory performance in PT programs.

The program is designed based on the Regulatory requirement called Minimum Standards for Medical Labs mandated in the Clinical Establishments (Registration and Regulation) Act, 2010.

This program is a basic Quality Assurance Program to encourage Labs to initiate Basic Quality / Minimum Quality Standards as mandated in Minimum Standards of CEA.

The program was launched in July 2020 and amended in Jan 2021.

The amended version can be downloaded from here –

This is a Voluntary Certification program for Basic Labs in the country and is issued for one time with 3 years validity. Minimum Standards offer Minimum Quality specification and is the 1st step for any small lab to start with its Quality Journey.

Source : https://nabl-india.org/

ISO/TS 5798 – Quality Practice for detection of (SARS-CoV-2)

A Wakeup Call from International Organisation for Standardisation (ISO)The future technical specification ISO/TS 5798

Chithambaranathan Sivasubramonian
Chithambaranathan Sivasubramonian

Associate Consultant

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.

Testing Blues – How can we trust the results?

Pandemic has created enough havoc in the medical laboratories testing space.

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 methods by 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.

Never have we been more acutely aware of the importance of reliability when it comes to laboratory testing. As the ongoing COVID-19 pandemic has highlighted, the development of accurate diagnostic tests plays an important role in outbreak management.

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.

A global assessment is needed to check the effectiveness of the Standards like ISO 15189 which were released almost 2 decades ago. Prior to that Medical Labs were accredited under ISO 17025 Std.

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.

Source : https://www.iso.org/news/ref2617.html

Accreditation & Certification for Medical Travel Programs

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 

Learn the answers to the following questions and many more by attending this webinar :

  • How GHA and QAI’s Collaboration will support medical travel in India
  • Key elements of a successful medical travel destination program
  • Why destination safety is the new catchword in medical travel
  • How Accreditation and Certification can help build patient trust in a COVID-19 world
  • Reviewing best practices in medical travel including protocols for COVID-19
  • How Global Healthcare Accreditation based on international standards accredited by ISQua can positively impact your medical travel program

For more information about Program outline, Speakers details, check the link below

For more details about the GHA-QAI partnership, please refer to the official press release.