NABH Announcement

Announcement from NABH – Revising Standards for Entry Level Certification Program for Hospitals & Accreditation Program for SHCO

PUBLIC NOTICE FOR COMMENTS ON DRAFT 2ND EDITION ENTRY LEVEL HOSPITALS CERTIFICATION STANDARD

NABH is in the process of revising standards for Entry level certification of Hospitals. The revision standards have been drafted.

The comments, suggestions, objections in the draft document are invited from public at large, including the stakeholders like hospitals and other clinical establishments, industry, consumer groups, etc. The comments may kindly be shared on the form within 15  days of publication of this notice on the website.

The last date for sending the comments is 31st January, 2022.

Click here to view the Draft Entry Level Standards for Hospitals – 2nd Edition

To fill the Feedback form pleases click on below link

https://docs.google.com/forms/d/e/1FAIpQLSd3bxRY0pfbxGllhueC3AsrXcCW8jQ_bCI_ueklowc-KQ7ezA/viewform?usp=sf_link

Download the Announcement from NABH Here

PUBLIC NOTICE FOR COMMENTS ON DRAFT 3rd EDITION SMALL HEALTHCARE ORGANISATION (SHCO) ACCREDITATION STANDARD

NABH is in the process of revising standards for Small Healthcare Organizations Accreditation Program. The revision standards have been drafted.

The comments, suggestions, objections in the draft document are invited from public at large, including the stakeholders like hospitals and other clinical establishments, industry, consumer groups, etc. The comments may kindly be shared on the form within 15  days of publication of this notice on the website.

The last date for sending the comments is 31st Jan 2022

Click here to view the Draft Small Healthcare Organizations Accreditation Standards 3rd Edition

To fill the Feedback form pleases click on below link

https://forms.gle/cAEKa6MZbm5g1RgJA

Download NABH Notification from here

NABH Announcements

Announcements from NABH – Fee Remittance Norms & Communication Matrix to be followed by all Applicant / Certified / Accredited Healthcare Organizations

Announcement 1 – Fee Remittance Notification

Kind Attention : All applicant / Accredited / Certified Health Care Organisations under all programs of NABH

In continuation to the previous notice of NABH related to fee payments  issued  on February 16, 2021, many Healthcare Organisations associated with NABH, are still making direct payment to Quality Council of India – NABH. NABH is facing d i f f i cu l t y in reconciling the amounts received directly as the details of payment are also not updated by the respective HCOs in their online portal.

To avoid unnecessary wastage of time  and  manpower  in  tracking  the  payments, NABH advises its stakeholders to  make payments  only through  the online portal  using the Payment Gateway  so that the payments  are appropriately  tracked  for  convenience  of all the parties.

In order to facilitate the Healthcare  Organisations  to reconcile  the fee payment  status,  NABH is requesting all the HCOs to follow the below steps with immediate effect:

  1. The HCOs a r e advised to login into their HCO account on the NABH portal for making payments through payment gateway via credit card/debit card/net banking.
  • HCOs are advised to refrain from depositing cash/cheque/DD directly into  any  account of Quality Council of India.
  • In case the HCO has no other option but Bank Transfer (NEFT/RTGS), it shall be responsibility of the HCO to update the transaction details like Unique Transaction Reference (UTR) Number, Date of Transaction, Transaction Amount, etc  on  the NABH Portal under the Make Payment category and inform NABH that the Payment was done and get the receipts generated for the payments made.
  • The HCOs are also requested to ensure that the payment details with respect to fee payments of current and previous accreditation cycles have been updated on the NABH portal account of the HCO, if not done earlier.

QCI-NABH plans to stop direct payments into its accounts done through DD/Cheque/Cash Deposit/Offline Bank Transfer (NEFT/RTGS) by March 31, 2022 and is seeking the cooperation from HCOs in this regards.

Download the notification from NABH here

Announcement 2 – Communication Matrix Released for the benefit of all Applicant / Certified / Accredited HCOs

NABH has earlier issued NABH communication matrix – NABH/Notification/Communication/2020/2049 dated 25th September 2020

All the applicant and accredited/ certified HCOs that are listed in the NABH portal have the provisions for making communications with the officials of NABH through “REMARKS COLUMN”. All HCOs are requested to utilise “REMARKS” for communicating/ raising queries regarding status of their applications for accreditation/ certification to ensure transparency as well as for records.

HCOs are also requested to refrain themselves from communicating through emails or telephonically. It is practically not possible to reply to each mail or phone call individually. Moreover, neither your communication nor reply from NABH is captured for the case record purpose.

In case, the queries of the HCOs submitted through remarks on the portal are not replied within three working days, emails to Program Heads may be sent, along with contents of email copied at on-line portal remark column. The list of all programs of NABH and the responsible Program Head with contact details are listed in the notification released by NABH.

Download the notification from NABH

Source : https://nabh.co/index.aspx

Notification from NABH

NOTIFICATION FROM NABH – CGHS , ECHS EMPANELMENT

Announcement from NABH

NABH has released a notification about empanelment process for CGHS / ECHS by HCOs.

Start of NABH CGHS / ECHS Portal for acceptance of online applications for Central Government Health Scheme (CGHS) & Ex Servicemen Contributory Health Scheme ECHS

National Accreditation Board for Hospitals and Healthcare Providers (NABH), a constituent board of Quality Council of India (QCI) is pleased to announce that the process of QCI inspections for ECHS & CGHS empanelment has now been digitised.

The Health care organisations will now be able to apply for and pay fee for empanelment through this online portal; guidelines for which are available on the NABH website at Steps to Apply for ECHS & CGHS Empanelment document.

Applicants desirous of getting their facilities assessed for CGHS / ECHS Empanelment are encouraged to apply online for prompt processing.

In case, the HCOs have any difficulty in applying, they may contact NABH Secretariat at E mail: nabh@nabh.co

Phone: 4260060

Download the notification and Step by Step Process to apply for the Empanelment Here

Announcement from NABH

For Small Healthcare Organisations

NABH has issued a notification recently for Small Healthcare Organisations (SHCOs) which are Accredited, under Quality Management Systems Program.

Notification calls for Self Declaration cum Undertaking from already Accredited organisations / organisations under accreditation process, on the Bed Capacity declared to NABH for Accreditation purposes.

Content of the notification in a nutshell is shared here :

It has been brought to notice of NABH that many hospitals and nursing homes that have enrolled under the SHCO accreditation program of NABH, despite having sanctioned bed strength of more than 50. Notification has clarified that the bed strength of the organization will be considered only on the basis of the sanctioned beds mentioned in the statutory licenses obtained by the organization from the competent authorities. All the hospitals and nursing homes which are accredited by NABH or are in the process of getting accreditation are hereby informed to declare the bed strength and submit an undertaking signed by head of the organization to this effect to NABH secretariat within 45 days of issue of this notice.

The format for submission of the declaration is enclosed herewith and the same needs to be printed on the stamp paper of value of Rs 100/-.Further the signed declaration has to be uploaded on the ‘HCO document’ section on the respective portal account of SHCO. In case, the hospital fails to submit the declaration as mentioned above, NABH may be constrained to initiate adverse decision against the non-conforming
hospitals as per the policy of NABH.

Download the Notification from here :

NABH Certifies, Accredits organisations which fall under the category of Healthcare Organisations and Small Healthcare Organisations which are defined as below :

Healthcare Organisation :

Healthcare organization (HCO) that should be above 50 beds to fall under the definition of Healthcare Organisation as per NABH

Small Healthcare Organisations :
Hospitals and Nursing homes or day care centres with bed strength less or equal to 50 Sanctioned beds.

Exclusions to the above definition :
a) Polyclinic Diagnostic Centres
b) Super Speciality Centres

Certification / Accreditation Framework :

The Certification / Accreditation Framework for each segment differs as the criteria set by NABH varies accordingly.

Essence of the Recent Notification :

NABH’s definition of Beds in the case of SHCO is “Sanctioned Beds” meaning number of beds approved, sanctioned by the Regulator, State / Central Licensing Authorities.

Infact Hospitals apply for various empanelments with State Govts, Central Govt agencies, PSUs, Pvt Health Insurers, Corporates etc for business purposes. Sanctioned beds is the statutory norm and should be quoted with all agencies .

However , it was repeatedly discussed in various industry forums , market place conversations that beds shown for empanelment purposes & for accreditation purposes is most often different and not same as the sanctioned beds approved by the licensing authorities.

Hospitals were declaring less number of beds to NABH while applying for Accreditation which is technically not correct. Infact this was pointed out by various other healthcare organisations at the market place frequently.

Way forward :

NABH has announced a roadmap for such hospitals which are covered under Accreditation Program for implementation by SHCOs , as follows :

The hospitals which are not eligible to be covered under SHCO accreditation program due to sanctioned bed strength more than 50 should switch over and apply under hospital accreditation program. Considering the fact that there could be a break in accreditation while switching over to hospital program, NABH has decided to give a transition period of 18
months from the issue date of this notification.

The hospitals are encouraged to implement NABH 5th edition of hospital standards with in
the given transition period and apply for accreditation under hospital program.

Further, during the transition period hospitals shall also be required to pay the shortfall of the
applicable annual accreditation fee based on the sanctioned bed strength of the hospital.

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

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

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.

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

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 :