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/

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

Regulate Online Health Aggregators

Health Ministry Advisory to States, UTs

The Union Health Ministry has asked all states and UTs to implement a time-bound action plan for regulating online health service aggregators who have neither provided any details of laboratories on behalf of which they are providing services, nor their registration status, including compliance to minimum standards.

The ministry has further advised that the Department of Home of the state concerned may also be requested to investigate such matters with an objective to prevent any kind of violation (civil or criminal/cyber or otherwise) of applicable laws.

In a letter written to all states and UTs on January 19, Health Ministry Secretary Shri Rajesh Bhushan referred to an August 2020 order by the Delhi High Court which directed the ‘concerned authorities’ to initiate action against any illegal online health service aggregators operating in Delhi in violation of the ‘applicable laws’, including the Clinical Establishments (Registration and Regulations) Act, 2010.

Health Secretary said the laboratories and other clinical establishments, providing any type of medical services, are required to be registered either under the Clinical Establishments (Registration and Regulations) Act, 2010 (in those states/UTs where it is applicable) or under the state laws, as applicable.

This ministry has also notified in gazette, the minimum standards for laboratory services vide notifications dated May 21, 2018, and the amendment notification dated February 14, 2020, the letter stated.

Certain online health service aggregators, operational in various parts of the country, may perhaps be neither providing any details of laboratories, on behalf of which, they are providing services, nor their registration status, including compliance to minimum standards, Secretary said in the letter addressed to chief secretaries and administrators of all states and UTs.

The details of qualified staff, as required for running the laboratory services, may also not be available on their online portals.

“Health being a state subject, and keeping in view the directions of the Hon’ble Court in the above said order, it is requested, that a time-bound action plan may be made and implemented, as per the applicable laws, for regulating such online health service aggregators, and the related service providers, operational in your state/UT.

“It is further advised that the Department of Home of the state concerned may also be requested to investigate such matters with an objective to prevent any kind of violation (civil or criminal/cyber or otherwise) of applicable laws. It is further requested that an Action Taken Report may be sent to this Department on a priority basis,” the letter said.

Download the advisory issued by Dept of Health, MoH&FW