Medical Testing Labs Quality Infrastructure

Medical Testing Labs Quality Infrastructure in India

Covid 19 Testing Criteria – Introduction of Rapid Antigen Testing by ICMR

ICMR is the Regulator for monitoring Covid Testing Strategy in the country.

Testing Strategy for Testing masses has undergone many changes in a dynamic manner since the beginning of the pandemic in the country.

ICMR has introduced Accreditation of the Med Testing Labs by NABL, as the eligibility criteria for Labs to conduct Testing .

Accessibility of Testing Labs to communities became the biggest stumbling block. Lots of calls, conversations across the markets asking for testing access. Urban markets stopped responding at some point, as the pressure became too much. Semi urban and rural markets didn’t have any access to testing at all.

Why are the labs not doing testing ?
Why is it that the testing facilities are not accessible to all ?
Who can actually do the Testing ?
Where are Testing Labs ?

The above were the questions asked by many on daily basis.

I have written an article in the News Letter of Andhra Chamber of Commerce about ICMR’s announcement about allowing only Accredited Labs in the country to do testing, the current Quality Infrastructure of Medical Labs in the country which actually determines the eligibility of the labs to qualify for testing. Its this lack of Quality Testing Infrastructure in the country that has restricted Medical Labs to qualify for Covid 19 Testing criteria.

ICMR has recently relaxed the norms to increase accessibility of basic Covid screening Test to all and introduced Rapid Antigen Test (Screening Test) as well to reduce the dependence on RTPCR Testing. This will ensure that screening test is made available to all.

Sharing the article published in Andhra Chamber of Commerce’s News Bulletin here .

Source : https://andhrachamber.com/pub/E-Bulletin_May_2021.pdf

About the Author

Ms Rama Venugopal
Executive Director
Value Added Corporate Services P Ltd

Email – rama@valueadded.in

Biobanks Accreditation Program

ISO 20387:2018 Standard

What is a Biobank ?

A Biobank is a depository for biomaterials from a representative portion of a human population.

The Biobank acts as a vault with intricate detailed information pertaining to the individuals from whom
biological materials have been collected.

Data collection and proper cataloging cataloging are essential components for the success of a Biobank

Types of Biobanks :

  • Tissue bank – (i) Surgical tissues (ii) Transplant tissues
  • Cancer / Tumor bank
  • Cord blood / Stem cell bank
  • Blood bank – Dried Blood Spots
  • Body fluids – (i) Synovial (ii) Urine (iii) Sputum (iv) Buccal scrapings (v) Sperm
  • DNA / RNA bank
  • Cornea bank

Utilities of Biobanks :

Routine work – health centers, hospitals, blood transfusion centers and Public / Private pathological laboratories.

Research work – biomedical experiments for a particular disease in a specific population.

Epidemiological work – monitoring in susceptible populations after disease outbreak, poisoning and / or pollution

Source : https://www.euindiacoop.org/2009/downloads/nk_ganguly.pdf

About the International Standard :

ISO has released an Accreditation Standard – ISO 20387:2018 for Biobanks. This Standard was developed to promote confidence in biobanks. The standard covers requirements that allow biobanks to demonstrate their competence in being able to provide biological material and associated data that meets the needs of research and development organisations.

A biobank is a biorepository that accepts, processes, stores and distributes biological material and associated data for use in research and clinical care. This biological material can come from human, animal or plant sources.

The accreditation process will cover collection (or acquisition), reservation, quality control, storage and distribution of biological material. It will also include a review of the management system underpinning these processes.

Biobanks, which hold hundreds of millions of biological samples – including those from humans, animals, plants, and microbes – help the global scientific community further everything from crop production to personalized medicine. Biobanks vary widely in terms of the kinds of biological material they hold, the activities they undertake, the services they provide, and their geographical location, size, and structure.

This document does not apply to biological material intended for food/feed production, laboratories undertaking analysis for food/feed production, and/or therapeutic use.

Why Accreditation of Biobanks needed ?

Businesses seek Certifications or Accreditations to various Quality Management Systems programs on Voluntary basis to demonstrate their conformance to Quality and Safety Management Systems. Sometimes these Certifications or Accreditations become mandatory when these are regulated by Regulators in the country.

Biotech is an emerging sector in India and this segment is witnessing fastest growth in the last one decade in the country. We have mushroom growth of Startups, young businesses and growth stage businesses in biotech sector. Many ventures are related to R&D domain too.

Biobanks have been steadily growing in the country and infact 15-20 years ago , many Cord Stemcell Banks were asking for specific Certifications, Accreditations related to their domain. We had only ISO 9001:2008 Std way back then and we were offering ISO 15189:2007 for testing related requirements of these banks. Some centers opted for AABB Accreditation from USA. Apart from these, there was no specific standard available for biobanks.

ISO has released an exclusive Standard for Biobanks now and this is an Accredtitation Standard developed exclusively for Biobanks. Bioresearch will attract lot of attention globally now and bio based organisations need to have effective Quality Management Systems in place to demonstrate their process and systems efficiencies, technical competencies on an ongoing basis.

Who is offering Accreditation for this Standard in India ?

Quality and Accreditation Institute is offering Accreditation to Biobanks in the country.

QAI is organising an Implementors Program on the standard and the details are as follows :

ISO 20387:2018 Accreditation Standard for Biobanks

Source : http://www.qai.org.in/

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.