Parakh – Unified Laboratory Network

Launched by DPIIT, Ministry of Commerce, Govt of India – National Network of Laboratories Infrastructure

What is #Parakh ?

#Parakh is a Government of India initiative for mapping of testing and laboratory infrastructure across the country on a unified network of testing laboratories. This is yet another significant step towards enhancing Ease of Doing Business. This portal incorporates all the accredited and recognised laboratories in the country on a Geographic Information System.

This is an interactive and user friendly system to find a Laboratories and Tests based on various parameters a user may require.

This program is a joint initiative of various boards, councils as mentioned below :

MSME
CSIR
DRDO
Textile Committee
NABL
Bureau of Indian Standards
FSSAI
Export Inspection Council, EIC India
APEDA

All types of Testing, Calibration Laboratories which are Recognised and Accredited are found in the portal.

This is an initiative which will benefit all citizens, user communities to have access to information related to various testing labs in the country that tests products or services.

Pandemic crisis has brought out this huge gap in the country’s lab infrastructure related information where no information was available about testing labs for PPEs, Ventilators, various other medical devices, Covid testing labs etc. All stakeholders were shunted from pillar to post hunting to testing labs information. Intense debates, discussions had taken place about lack of information about National Testing Labs Infrastructure. That’s how DPIIT has initiated the process to create the National Network of Laboratories which will immensely benefit not only domestic trade but International Trade as well.

Portal currently has a list of :

  • 6581 laboratories offering testing services related to
    • 60558 products and services
    • following 367209 Test Methods

All Laboratories in the country are open to get their laboratories listed in the portal.

Source – https://parakh.ncog.gov.in/indexpage

Customers Quality Systems – Supply Chain getting Trained

Orientation Program for IVD Manufacturers about Various Quality Systems Programs implemented by their User Industry – Hospitals, Med Labs , Other Healthcare Organisations

Supply Chain is showing interest to learn about various Quality Systems implemented by their Customers

Customers Quality Systems – Supply Chain getting Trained

Got a call from an IVD Manufacturer last week expressing interest to get his team trained on various Quality Management Systems followed by healthcare organisations.

I first thought I heard it wrong, I thought he was seeking training for his team on Med Dev QMS. When I asked the question, he said NO and his question is about getting his team members understand a little about various QMS Programs implemented by their customers like NABL, NABH , CAP, QAI Programs.

I was a little surprised and asked him for the reason for choosing a topic like this, though I could quickly guess where he would be heading to. He has mentioned that they are supplying their products to multiple categories of healthcare organisations . Each one comes up with some Certification, Accreditation program that they are implementing. Having implemented Med Dev QMS & Product Certification Programs in house, he felt that its appropriate for his team to acquire some basic knowledge about their Customers Quality Systems Programs and ensuring that as Vendors to the respective healthcare orgns, they would prefer to provide necessary inputs, information that are needed by these Healthcare Organisations (HCOs) during their Quality journey.

This is what is emerging across the globe. Many businesses / sectors are ensuring that their Supply Chain is also in sync with their Quality Systems Journey. When a Mfrer or a Service Provider delivers a Product or a Service to end user / customer, as a finished good, he/she has to doubly ensure that his supply chain also maintains high Quality Standards. It becomes imperative for the Vendors, Suppliers , Stakeholders who are part of the supply chain to be in sync, in alignment with the Quality Systems adopted by their customers.

Similarly, businesses that are seeking support from suppliers, should also make an effort to understand the Quality Systems – be it Product or Systems Certifications, implemented by the Suppliers in their respective organisations. This is the fundamental requirement of Vendor Evaluation in any business. Understanding the Suppliers Quality Systems Programs Matters for Businesses too ! Many Regulated Business Sectors, across the globe, have initiated this exercise of bringing the Supply Chain under some Quality Standards, Systems Programs. Automotive Sector was the 1st sector to introduce this almost 2 decades ago. Many other sectors which are under Regulatory Control are slowly introducing this concept.

This manufacturers/suppliers, being the suppliers to many healthcare organisations, come under the supplier category to these businesses. Healthcare Sector being regulated (be it Products or Services) in the country now, Supplier Quality Compliance will become a norm sooner or later.

We have customised a 3 day program for the IVD Mfrer’s team comprising of :
– Technical Team
– Sales Team
– Customer Support Team
– Management Team

The program was designed in such a manner to provide them a bird’s eye view on various Healthcare Certification, Accreditation Programs that are currently available in India for healthcare businesses to choose.

We have also designed a session on Minimum Standards that are adopted in the country as Regulatory spec which addresses basic QMS to be implemented by Med Labs in the country.

It was interesting session fielding questions from IVD Mfrers about Quality Systems Programs in HCOs.

  • Some interesting questions posed by them :
  • For a start up lab, Is there a bare minimum period required to get the accreditation, if all the criteria is met?
  • Is there any minimal number of parameters in scope of testing for applying certification ?
  • What is the difference betn Certification & Accreditation Program when most of the quality mgmt systems clauses are similar ?
  • Is it compulsory to do ILC ? Frequency ?
  • When there are multiple Certification , Accreditation Programs available for Med Labs, how to differentiate and choose a relevant, appropriate program for HCO

Matured Participants and the Quality of the interactions was highly invigorating .

Were actually surprised when they were asking questions related to :
– Voluntary withdrawal from Accreditations :
– Suspensions criteria
– Eligibility of the HCOs to reapply
– Normal scenarios , reasons for such actions taken by Accreditation Bodies
– Any penalties , punishments for non compliances

Some screen shots from the session :

3 days of orientation program came to a close today. Bird’s eye view of all National , International Certification, Accreditation Programs , Minimum Standards – Regulatory requirements were covered. Program was well received and appreciated by the participants.

Informative, customised content, pretty detailed, well explained, looking forward to detailed sessions

Some feedback received by the end of the session.

Moving forward, Quality Systems Implementation Programs become more inclusive in nature in near future. Businesses will ensure Quality of their Supply Chain and Suppliers will show more interest to learn about their Customers Quality Systems Implementation Programs. More inclusive it becomes, supply chain gets strengthened and end users will be assured of better Quality & Safe Products and Services.

Session was handled by :
Dr Srivatsan , Expert – Healthcare Quality Management Systems
A A Srinivasan – Principal Consultant
Chithambaranathan – Associate Consultant

Posted by :

Rama Venugopal
Executive Director
Value Added Corporate Services P Ltd
Click Here for More Updates

Accreditation of SARS-CoV-2

Announcement from NABL on Covid 19 Testing

Accepting applications for accreditation of SARS-CoV-2Announcement Released on 25th May 2021

NABL is accepting applications from laboratories performing Real Time RT PCR Test, RT LAMP Assay, CRISPR – Cas9 based assay, Isothermal Nucleic Acid Amplification test (Closed System) for SARS-CoV-2. Laboratories may apply directly for accreditation of SARS-C0V-2 by different methods.

The laboratories which have been granted accreditation for Real Time RT PCR Test for other RNA viruses during the Final Assessment are advised to apply for accreditation of SARS-CoV-2 during the Onsite Surveillance or earlier.

The laboratories which have been granted accreditation for Real Time RT PCR Test for other RNA viruses during scope extension are advised to apply for accreditation of SARS-CoV-2 during the Renewal of accreditation or earlier.

Download the Announcement from here

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

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

Announcement from NABL

QR Code in Test Reports / Calibration Certificates Made Mandatory

Mandatory QR Code in Test Reports issued by Medical Labs Announcement from NABL

QR Code on the Medical Test Reports Medical laboratories may note that, in a memorandum issued on 13.05.2021 by the Ministry of Civil Aviation, Government of India, it is mandatory for travellers flying abroad to carry their negative RT-PCR test report having QR codes linking to the original report.

Medical Laboratories should provide QR code on all test reports issued which can be scanned using any QR scanning application available on mobile / any devices to authenticate and reproduce the test report online. This will prevent the manipulation of test results & the usage of fake test reports.

Laboratories to ensure that all the requirements of ISO 15189, NABL, regulators are met. Authorized test results in a tamper-proof and non-editable test report will build trust in laboratory results.

Download the advisory from NABL here

Mandatory QR Code on the Test Reports issued by Testing Labs / Calibration Certificates issued by Calibration Labs

Labs should provide QR code on all test reports/calibration certificates issued which can be scanned using any QR scanning application available on mobile / any devices to authenticate and reproduce the test report/calibration certificate online.

This will prevent the manipulation of test results/calibration data & the circulation of forged test report/calibration certificate in the market. Interest of the consumer / end user of the product and the reputation /Image of the lab are also protected.

Download the advisory from NABL here

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

Carrying Fake Covid 19 test Reports from India

Travel ban on Indian Passengers going global

Almost a third of all Canada-bound flights with Covid positive flyers from Delhi

Nearly a third of international flights that landed in Canada with passengers that tested positive for coronavirus upon arrival between March 3 and 19, were from Delhi, data sourced from Health Canada showed. A total of 98 international flights arrived in the North American country during this period, of which 30 were from Delhi, and of these, 21 were operated by Air India and nine by Air Canada.

Of these 30 flights from Delhi, 21 landed in Toronto and nine landed in Vancouver. As of February 14, Canadian authorities compel flyers over the age of five to provide a Covid-19 negative molecular test certificate before boarding a Canada-bound flight. Pointing to “lacunae” in test reports, Air India said, “Air India as a responsible airline is strictly conforming to the rules and protocol laid down by different countries. Only passengers with Covid negative reports are being allowed to board international flights from any destination in India. Hence, Air India cannot be held responsible for any lacunae on the issue of passenger test reports”. Air India had come under fire from Hong Kong authorities as well last year for transporting passengers who tested Covid-19 positive upon arrival. Because of this, the flag carrier faced several 15-day ban from Hong Kong administration from flying into the city.

(Source : https://indianexpress.com/article/business/aviation/almost-a-third-of-all-canada-bound-flights-with-covid-positive-flyers-from-delhi-7240456/)

After New Zealand, will other countries ban travellers from India?

It’s not just New Zealand that has seen a rise in cases because of passengers arriving from India. Several other countries have reported many Covid-19 passengers arriving in flights that originated in India.

Few days ago, New Zealand announced it was suspending entry of travellers from India, including its own citizens. The move comes after New Zealand recorded 23 new positive coronavirus cases at its border of which 17 were from India.

Source : https://indianexpress.com/article/explained/explained-new-zealand-bans-travellers-from-india-will-other-countries-follow-7264032/

Today, HONGKONG flight bans announced (again) :

•Flights from India, Pakistan and the Philippines banned for 14 days starting April 20 (midnight)
•Those who stayed there for more than 2 hrs also banned •21-day quarantine, with additional requirements: 7-day self-monitoring and day 26 test.

The reason is Frightening : a single flight from Delhi to Hong Kong has so far led to 47 imported cases (& counting). All were required to do pre-departure testing and all were tested upon arrival. Yet, most of the cases were detected in hotel quarantine (most detected on day 12). All 47 passengers on Vistara flight UK6395 from New Delhi to Hong Kong on April 4th have now tested positive for COVID-19.

What is the Problem Statement in all above scenarios ?

Each country has released its own travel advisory and the mandate is any passenger entering into the country should carry a “Negative Molecular Test Certificate”. That’s fine . So the passengers were screened in India, test reports presented by passengers were checked, cleared and passengers landed into those countries as well. They were detected Positive there during quarnatine phase .

So where did the things go wrong ? At Airlines Travel Desk at India ?
What was checked by these travel desk teams, ticketing teams ?
How far are they trained to check the authenticity of the test reports issued ?
Since almost all countries , embassies insist on Test reports from Accredited Labs, how did the Accredited Labs issue such reports ?
Were these reports issued by Accredited Labs or by any Labs in the first place ?

There were reports that these are photo shopped reports too. If such is the scenario, how come airport travel desk teams are not trained ? Whose fault it is , not training them ?
Do these travel desk teams know whom to reach out if they need guidance while checking authenticity of the reports ?
Are they trained on reporting or getting travellers arrested immediately for submitting fake reports ?
Why should Brand India’s reputation be at stake when simple processes, protocols are not followed by Airlines Staff ?
Why don’t Airlines, Hospitality industry, Travel Agents etc undergo mandatory training from Accreditation Boards to equip themselves better ?
What is the solution for detecting such fake reports ? If solutions are available, why don’t Medical Labs introduce such checks , controls or systems to save the trouble for all ?
In the opening para of this post, Air India official said Air India is not responsible for the lacunae in the issuance of the Test Reports. How correct he is in making such a statement ? As an agency responsible for verification of such reports as its the norm of importing country, how can Air India wash off its hands like this ?

Indian Travellers are risking their lives as well as the lives of international population by resorting to these fradulent practices. But they get severely punished in foreign land for such violations too. Incidents like this will affect the Travel & Trade between the countries .

As Exporting Country, we need to have strong checks and balances to ensure that our Country’s Reputation doesn’t got for a toss like this in the global markets ! We know about the norms imposed by Importing countries and its our duty to ensure that all stakeholders are thoroughly trained, sensitised on all protocols.

Author :

Ms Rama Venugopal, Executive Director
Email – rama@valueadded.in

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/

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/