LATEST NOTIFICATION FROM NABH ON IMPLEMENTATION PLAN OF 3RD EDITION OF NABH SHCO ACCREDITATION STANDARDS
Announcement from NABH
NABH has released a notification on implementation of 3rd Edition of NABH SHCO Accreditation Standards.
Key information from the notification is shared below :
The 3rd Edition of NABH SHCO Accreditation Standards along with the Guidebook has been released on 31st August 2022.
The effective date of Implementation of the third edition standards for SHCO would be as below:
a. All accredited SHCOs must be in full compliance with third edition by 1st March 2023 and shall submit the documentary compliance for the same by this date. The onsite compliance shall be verified during next on-site assessment (which can be either surveillance or renewal assessment).
b. All the assessments (Pre, Final, Renewal, Surveillance) shall be based on Third Edition w. e. f. 1st March 2023.
c. For all the assessments before 1st March, 2023, decision shall be based on Second Edition. However, such SHCOs would require to comply with the Third edition in next six months from the date of accreditation.
d. NABH will not accept any application (New as well as Renewal) on Second Edition Standard after 31st December 2022.
The whole process of transition will be completed 1st September 2024.
NOTIFICATION – IMPLEMENTATION PLAN OF 3 rd EDITION OF THE NABH SHCO ACCREDITATION STANDARDS
The 3rd Edition of NABH SHCO Accreditation Standards along with the Guidebook has been released on 31st August 2022
NABH has released notification on Implementation plan of 3rd Edition of the NABH SHCO Accreditation Standard as follows:
• All accredited SHCOs must be in full compliance with third edition by 1st March 2023 and shall submit the documentary compliance for the same by this date.
• All the assessments (Pre, Final, Renewal, Surveillance) shall be based on Third Edition w. e. f. 1st March 2023
• For all the assessments before 1st March, 2023, decision shall be based on Second Edition. However, such SHCOs would require to comply with the Third edition in next six months from the date of accreditation.
• NABH will not accept any application (New as well as Renewal) on Second Edition Standard after 31st December 2022
The whole process of transition will be completed by 1st March, 2023.
NABH has released Notification on May 30,2022 on launching its new portal for 5th edition Hospital Accreditation Standards w.e.f. 01.06.2022
The new portal is designed in a manner to ensure objectivity, transparency, seamless functioning and a faster turn-around time. It also incorporates use of mobile applications to ensure real-time assessment process supported by objective evidence.
All the NEW APPLICANTS under the hospital accreditation programme are requested to register on the new portal w.e.f. 01-06-2022 via the link https://hcoaccreditation.nabh.co
The new portal is to be used only for the hospital accreditation programme, the other accreditation programs will continue to run on the existing portal.
World Accreditation Day Conference – Post Event Update
World Accreditation Day Conference 2022 – Post Event Update
WAD 2022 Conference jointly organised by International Accreditation Services (IAS), USA; Bureau of Indian Standards and Consultants Consortium of Chennai ended on June 10th 2022 with a positive a note.
Two days conference held on June 9th and 10th had eminent speakers from India and abroad , from various sectors , sharing rich insights about Standards, Certifications, Accreditations, Inspections & Regulations related to Sustainability and Environment across the globe.
Two days of intense learning sessions came to an end on June 10th.
Conference had 324 delegates registering for multiple sessions across two days and the feedback received from them is very encouraging.
The conference is supported by many Trade and Industry Platforms as listed below :
Sharing few pictures of the event for reference :
Inaugural
Speakers introduction
Speakers introduction
Dr R Velraj & CCC’s VP Mr Ramkumar Sivaraman
Inaugural Session
Inaugural SessionDr R Velraj’s Keynote AddressBIS TeamDR R Velraj, VC, Anna University & Shri USP Yadav , DDG – BIS , Southern RegionDr Deepak Samuel V, CMR – NCSCM, SpeakerMr Nambi , GC Member – CCCDr M Sasikala NHHID – Anna UniversityMr Ashish Dev Lead Auditor & Tutor- COTECNA IndiaMe U S P Yadav, Scientist F and Deputy Director General , ( Southern Region) – BISOffsite DelegatesMr Premkumar Jayvin Md/ Principal Consultant , Jayvin Management Systems and SolutionsMr K Vijayaveeran Scientist D & Joint Director Bureau of Indian StandardsDr Ghadevaru Sarathchandra, Professor and Head TANUVAS & Representative of NABLDr R Velraj & Dr Ghadevaru SarathchandraDr K Sankaran , Dr M Sasikala – NHHID HubMr Anil Jauhri, Ex CEO – NABCB & SpeakerMr Ramanathan Ganesan DQS India , SpeakerDr Jagannath Patil Advisor, NAAC India & SpeakerMs Nisha Rani Legal & EIA Expert , SpeakerMs B Sandhya, Scientist G – Head – Certification, KIHT, SpeakerMr Vivek Kulkarni, Laundry Expert , SpeakerMr R Deswal, President , AOIL & SpeakerDr Harinder Singh Oberoi Advisor ( Quality Assurance ) – FSSAIMr Karthik S Easwar, Head, Quality and Regulatory Affairs, IAS, USAMr VIshnu P. Sudarsan Partner, J Sagar AssociatesDr Nisha Kohli, Founder & CEO CorpStage – Sustainability Platform, SpeakerDr Aparna Dhawan Executive Director, TIC Council IndiaMr Amit Thusu, Sr. Director – Climate Actions, Global Carbon Council, SpeakerMs Jyotsna Belliappa, Founder and Director – Bluesky Sustainable Business, SpeakerMr Prosenjit Mitra, Dy. General Manager, TUV SUD South Asia, SpeakerMr Sandeep Bhargava CEO – Onecert International Nominee – ACBI, SpeakerMr Karthi Thiyagarajan, GC Member – CCCMr Thiruvengadam, GC Member – CCCMr D Srikanthan, Secretary – CCCGC Members – CCCCCC TeamDelegates – OffsiteCCC TeamCCC TeamConference Venue – National Centre for Sustainability and Coastal Management
Session Videos are shared here for industry and stakeholders benefit. Please check the links below
INAUGURAL SESSION : Theme – Sustainability in Economic Growth and the Environment
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:
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.
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.
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 .
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 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.
