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

National Commission for Allied and Healthcare Professions Bill, 2020

The National Commission for Allied and Healthcare Professions Bill, 2020, was passed by Rajya Sabha recently. The bill had 110 recommendations, the government accepted 102 while six recommendations were accepted with slight modifications. Only two recommendations were not accepted.

The bill provides for regulation and maintenance of standards of education and services by allied and healthcare professionals, assessment of institutions, maintenance of a central register and state register and creation of a system to improve research and development and adoption of the latest scientific advancement.

The Bill defines ‘allied health professional’ as an associate, technician, or technologist trained to support the diagnosis and treatment of any illness, disease, injury, or impairment.  Such a professional should have obtained a diploma or degree under this Bill.  The duration of the degree /diploma should be at least 2,000 hours (over a period of two to four years).

  • Healthcare professional: A ‘healthcare professional’ includes a scientist, therapist, or any other professional who studies, advises, researches, supervises, or provides preventive, curative, rehabilitative, therapeutic, or promotional health services.  Such a professional should have obtained a degree under this Bill.  The duration of the degree should be at least 3,600 hours (over a period of three to six years).
     
  • Allied and healthcare professions: The Bill specifies certain categories of allied and healthcare professions as recognised categories.  These are mentioned in the Schedule to the Bill and include life science professionals, trauma and burn care professionals, surgical and anaesthesia related technology professionals, physiotherapists, and nutrition science professionals.  The central government may amend this Schedule after consultation with the National Commission for Allied & Healthcare Profession
  • Bill passed by the Rajyasabha is shared here for reference

Financial assistance for the establishment of AYUSH Super Specialty Hospitals and Day Care Centres

Champion Services Sector Scheme for Medical Value Travel

Financial assistance in the form of Interest Subsidy for the establishment of AYUSH Super Specialty Hospitals/ Day Care Centres under Champion Services Sector Scheme for Medical Value Travel Ministry of AYUSH invited application in the prescribed format under Central Sector Scheme for establishment of AYUSH Super Specialty Hospitals/ Day Care Centres under Champion Services Sector Scheme for Medical value Travel for the year 2020-21 from the eligible private entrepreneurs registered under Societies Registration Act/ Trust/ Companies Act vide advertisement in leading news papers as well as through the website of Ministry of AYUSH. The last date of submitting applications was 08.03.2021. However, to give ample time to the investors, Ministry has extended the last date and now applications can be submitted in prescribed format up to 5:30 P.M. of 08.04.2021

The eligible private entrepreneurs may submit complete applications in prescribed format along with the required documents/ information to the Ministry of AYUSH. The detail of guidelines is available on the website of the Ministry of AYUSH and can be downloaded from here

The applications in triplicate duly spiral bound and completed in all respect along with check list should reach to the :

Advisor (Ay.), Champion Services Sector Scheme
Medical Value Travel, M/o AYUSH, Room No. 207, 2nd Floor, Ayush Bhawan, B-Block, GPO
Complex, INA, New Delhi-110023.

Information Source : https://main.ayush.gov.in/event/financial-assistance-form-interest-subsidy-establishment-ayush-super-specialty-hospitals-and

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/

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/

Webinar on Increasing Fire Accidents in Hospitals

Panel Discussion – Possible Reasons & Way forward to take Preventive Measures

In view of the recently reported fire accidents in the country, (both in dedicated Covid Care Centers and other Hospitals, including Nursing Homes), an increasing amount of intolerance is visibly seen at the market place from public, various stakeholders towards rising fire accidents in healthcare facilities. Recent SC order in Dec 2020 called for immediate fire audit inspection of all covid hospitals in the country.

A Webinar to brainstorm about the reasons for increasing Fire Accidents in Hospitals in the form of panel discussion is taking place on Feb 9th 2021 from 3 – 5 pm.

Two rounds of Panel Discussions focussing on Possible Reasons & Way forward to take Preventive Measures is designed.

Session is organised by Consultants Consortium of Chennai and supported by NABH , AHPI, QAI, UL India and FOCUS to kick start series of deliberations.

Who should attend ?

Hospital Promoters, Medical Professionals, CEOs, COOs, Facility Incharges, Building Mainteanance Teams, Biomedical Teams, Operations teams, HVAC Teams, Utility maintenance teams , QA Teams, Safety Consultants and Experts, Hospital Planners, Designers, Medical Planners, Architects, Electrical Safety Engineers, Civil Engineers

Date – Feb 9th 2021, Tuesday | Time – 3 pm – 5 pm

No Registration Fee. Prior regn is a must.

Regn Link – https://bit.ly/3oSMkWV

Full Program Info can be downloaded from

http://ccc-consultants.org/webinar-on-increasing-fire…/

Program is live telecast from CCC’s youtube page –

https://bit.ly/3a4mJWM

Contact Coordinators :

Rama Venugopal – 9840870532 – contact@ccc-consultants.org

D Srikanthan – 9003056539 – secretariat@ccc-consultants.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

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