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

Fire Safety Scenario in Indian Hospitals

Dr Bashyam Srivatsan
Principal Consultant
srivatsan@valueadded.in

In view of the recently reported fire accidents in the country, (both in dedicated Covid Care Centers and other Hospitals, including Nursing Homes), this post captures the latest initiatives from Ministry of Home Affairs, Govt of India to address the fire safety lapses and arrest the rising rate of fire safety incidents in covid care centres in the country.

The urgency of addressing the fire safety norms is triggered by the Apex court on November 27 ,2020 followed by  fire outbreak in the ICU of a designated COVID hospital at Rajkot in Gujarat in which five patients died. Apex Court  had pulled up the states for not taking any concrete action to mitigate the problem despite repeated instances.

The issue had cropped up before the top court which was hearing the matter in which it had taken cognisance regarding need for proper treatment of COVID-19 patients and dignified handling of dead bodies in the hospital.

The Centre informed the Supreme Court that it has directed all states and Union Territories (UTs) to send status report by December 4 on the implementation of fire safety guidelines to prevent fire incidents in hospitals or nursing homes.

Union Home Secretary has directed all the Chief Secretaries of states to ensure due compliance of the November 28 ,2020 directives regarding fire safety guidelines and to immediately re-inspect all hospitals or nursing homes to prevent fire accidents in future.

The government informed the apex court that all states and UTs have been asked to send their action taken reports (ATRs) on the enquiry conducted by them on fire incidents that have occurred in hospitals or nursing homes in the last five years.

All the states and UTs have been directed  by Central Govt to update their respective local building Bye-laws or Fire Service Act and to align and make them sync in line with ‘Model Bill on Maintenance of Fire & Emergency Services 2019’ circulated by Ministry of Home Affairs on September 16, 2019 read with other advisories issued from time to time under National Building Code of India.

NABH (National Accreditation Board Certifying & Accrediting Hospitals & other healthcare organisations for Quality and Safety practices), on its part has asked the NABH accredited & certified Hospitals to send the report by 31st January 2021 covering the following –

  • To review their Fire Safety Plans, policies and equipment and also update the names of designated Fire Safety Officers in case required.
  • To conduct extensive fire safety mock drills and trainings including mock evacuation of critical patients, checking the functionality of the fire hose reel etc.
  • To review and resubmit their updated Fire NOC / application for renewal to the NABH Secretariat. In case NOC is not applicable, as per the state laws, third party audit is to be provided.

The necessary documents must be uploaded in the respective online portals (all accredited Hospitals as well as the HOPE Old Portal Organizations).

HOPE Certified organizations can mail the document with their reference number at admin.hope@qcin.org

Having worked with around 100 plus healthcare facilities in the last one decade, starting from OP clinics, Nursing Homes, Small, Mid, Large Hospitals and upto 1500 bedded Medical College Hospitals etc in South India, we believe that the reasons for rising number of safety incidents are multifold.

We can classify the challenges in implementing Fire Safety compliances & protocols faced by healthcare orgns into following categories –

Infrastructure :

National building code is the base guideline document which specified guidelines for constructing Hospitals. It talks about roof height, staircase, Corridor, Emergency exit etc but very strangely the guideline is silent on constructing a ramp, a mandatory requirement in Hospital building having multiple floors.

Fire system having water storage tank, Hose reels, sprinklers, Fire sensors, Fire Extinguisher, jockey pump, fire pump etc also fall under infrastructure specifications listed in NBC. Unfortunately only very few hospitals have complied with all requirements in letter and spirit.

Manpower:

Dedicated Fire Safety Officer, at least 40% staff trained to handle fire equipments and extinguisher in each shift is lacking in majority of Healthcare organizations as majority of the hospitals don’t even have Safety Officers, Facility Management Teams with necessary skill and competency to handle emergencies.

Training :

Fire Safety training during induction and regular training of existing staff is mostly lacking in many Healthcare organizations.

Mock drills:

Normally conducted during accreditation process but not done on a regular basis to demonstrate the capabilities during real fire emergency scenarios. Safety practices are not inculcated as a culture post certification, accreditation process.

Fire License and Fire NOC :

Fire NOC is obtained by majority of the facilities , but the conditions of NOC are never implemented in totality , hence paving way for very few healthcare organisations obtaining the fire licenses. Majority of the hospitals are still outside this framework.

Way forward to make Safety Practices an Organisational Culture and how to meet the fire safety compliances mandated by statute :

  • Top management commitment is must for budgetary allocation and for right policy decision in this regard.
  • Take the help of fire department personnel or qualified & competent fire safety personnel (listed out in the NBC) to get list of requirements as part of compliances . A third party audit is useful to identify the GAPs in the system.
  • Maintenance or any other staff needs to be given role clarity and responsibility to coordinate with Management, Fire department, Fire equipment vendors and contractors etc to establish the fire safety system in the hospital and meeting all fire safety norms and licenses requirements as mandated as per local laws.
  • Once fire system is established Quarterly training to be given to all staff on fire safety protocols, handling fire safety equipments, evacuation of patient and staff, code red protocols etc
  • Fire Safety training should be made part of induction training programme for all new joiners which is not followed as a HR protocol in many healthcare organisations.
  • Regular maintenance of fire safety system to keep it battle ready.

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

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.  

Covid19 Vaccine – Operational Guidelines

Covid19 Vaccine – Operational Guidelines

MoH&FW Announcement

Min of Health & Family Welfare, Govt of India has released Covid 19 Vaccine – Operational Guidelines for all refer.

This guidance document has listed out the GoI’s vaccination strategy with clear guidelines for all follow.

NABH Announcement

NABH Announcement

Fire Safety Compliance in all Certified / Accredited Hospitals

In view of many reported recent fire accidents, all the NABH Accredited/ Certified Healthcare Organizations are requested to comply with the following:

  • To review their Fire Safety Plans, policies and equipment and also update the names of designated Fire Safety Officers in case required.
  • To conduct extensive fire safety mock drills and trainings including mock evacuation of critical patients, checking the functionality of the fire hose reel etc.
  • To review and resubmit their updated Fire NOC / application for renewal to the secretariat. In case NOC is not applicable, as per the state laws, third party audit is to be provided.
  • The necessary document much be uploaded in the respective online portals (all accredited Hospitals as well as the HOPE Old Portal Organizations).
  • HOPE Certified organizations can mail the document with their reference number to :
    admin.hope@qcin.org
  • This is for all partner organizations, across programmes.
  • The exercise must be completed at the earliest but no later than 31st January 2021.

NABH Accreditation Standards for Medical Imaging Services – 2nd Edition

NABH Notification for Medical Imaging Services – 2nd Edition Migration Plan

For Medical Imaging Services (MIS) NABH will start conducting assessments as per 2nd Edition standard from 01st February 2021 onwards and no fresh or renewal application will be accepted as per 1st Edition standard after 01st January 2021.  

The MIS centres which are accredited (either fresh or renewal) as per 1st Edition before 31st January 2021 will be required to upgrade their centres to the MIS 2nd Edition before 30th June 2021 and submit compliance report to NABH in the form of an internal audit report based on MIS 2nd edition. The actual implementation of the 2nd edition by the center will be verified by NABH during the next due assessment. 

NABH has organised a Program on Implementation (POI) on NABH Accredittaion Standrds for Medical Imaging Services (2nd Edition) on February 27 & 28, 2021.

The training details are available at the link below : https://www.nabh.co/EventDetails.aspx?id=81

Revised Migration plan for transition of Applicant/Accredited MIS Centres towards the implementation of NABH Accreditation Standards for Medical Imaging Services – 2nd Edition in their respective centres is being issued by NABH and the document can be downloaded from the link below :