Advisory for Minimum Essentials Fire Safety Measures

NABH – Advisory for Minimum Essential Fire Safety Measures for All Healthcare Facilities

NABH (National Accreditation Board for Hospitals And Healthcare Providers) has issued an advisory recently on Minimum Essential Fire Safety Measures to be followed by healthcare organizations in the country.

This was the advisory for Minimum Essential Fire Safety Measures applicable to Healthcare Units under all schemes of Certification and Accreditation offered by NABH. These guidelines are meant to ensure patient safety and in no way absolves the organization of fulfilling its statutory obligations with regard to fire safety while implementing Certification, Accreditation Programs in the country.

The Advisory has listed out the scenarios where a Healthcare Organisation has Fire NOC, has No Fire NOC in place. The content of the advisory released by NABH is shared below for information purposes :

Advisory Content :

When the Healthcare Facility has Fire NOC in place, advisory calls for health facilities to check on the compliance to the minimum essential home Act/DHO fire safety measures are in place and or functioning.

Advisory says when the Healthcare facilities don’t have Fire NOC , following steps have to be addressed by a healthcare organisation :

  • Approval/Registration from local health authority Eg: Nursing home Act/DHO
  • If Fire NOC is not applicable, organisation has to provide valid justification for the same.
  • If Fire NOC is applicable, confirm that the organization has applied for fire NOC and there is regular correspondence (at least once in three months) with fire department which is acknowledged. Any correspondence received from the fire department has to be submitted.
  • In the absence of Fire NOC, Third Party Inspection Certificate should be made available.
  • The third-party audit should provide evidence to suggest that statutory norms are adhered to Any Observation by the third party should have been addressed.
  • The third-party inspection certificate is valid for a maximum period of one year
  • Head of the organization/Promoter to give an undertaking on the organization’s letter-head stating that fire safety measures are in place and adhered to at all times.
  • During assessment, verify that the points in the checklist are in place and are functioning

*NABH prescribes that Fire & Life Safety Inspection Certificates under NABCB accreditation issued by NABCB accredited Type ‘A’ Inspection Bodies for Fire & Life Safety Inspections of hospitals/health care providers shall be in accordance with the following:
a. National Building Code of India
b. Model Bill to provide for the maintenance of Fire and Emergency service for the state (2019)
c. Respective State Fire Safety Rules
d. NABH accreditation requirements for fire safety and applicable statutes
e. Any other applicable statutes.

Such Fire & Life Safety Inspection Certificates shall be accepted in lieu of statutory Fire NOC, only for consideration for the purpose of NABH accreditation. This does not absolve the hospitals/health care providers from complying to Fire NOC requirements/any other extent applicable statutes. It shall be sole responsibility of hospitals/health care providers to obtain Fire NOC, as applicable.

NABCB accredited Inspection Bodies shall be required to issue a final Fire & Life Safety Inspection certificate under NABCB accreditation bearing NABCB Accreditation Mark after the inspection is carried out and satisfactory corrective action and resolution of non-conformities, if any.

NABH accreditation requirements for Fire & Life Safety : (in addition to above)

  1. Firefighting equipment like wet riser, hydrants, auto sprinkler, fire alarm system, fire extinguishers of all types and sizes should be available as per table below (adapted from NBC 2016).
  2. Operational and maintenance plan for firefighting equipment including refilling of extinguishers.
  3. Up to date fire drawings to be available. Where applicable, the fire drawings should also specify the location of fire dampers.
  4. Fire detection and smoke detectors exist across all floors. The detectors shall be tested for functionality at regular intervals, and records maintained.
  5. Central fire alarm system is installed at a location which is staffed 24/7.
  6. Fire exit plan for each floor. Exit door should be openable and free from any materials which will obstruct way.
  7. Fire Exit signage on all floors well illuminated/ self-glowing, as per NBC guidelines.
  8. Emergency illumination system in case power goes.
  9. Designated place for assembly of patients and staff in case of fire.
  10. Mock fire drill records and schedule of conduct of drills.

Minimum Requirements for Fire Fighting Installations

Advisory can be downloaded by clicking on the link below.

Source of the Information :
https://nabh.co/Announcement/Revised%20Advisory%20for%20Minimum%20Essential%20Fire%20Safety%20Measures%20-20.09.2022.pdf

Above advisory says that Healthcare organisations need to obtain a Fire and Life Safety Inspection Certificates from Third Parties – Type A accredited Inspection Agencies accredited by NABCB in accordance with NBC 2016 and various other Regulations as mandated under various statutes, Rules, laws of centre , state etc

Hospitals , Healthcare Institutions have to look out for Type A Inspection Bodies (IBs) accredited by NABCB if they don’t have Fire NOC to seek Fire and Life Safety Inspections. Type A IBs have to obtain necessary accreditation scope as per various regulatory requirements, standards in the country. These IBs may have to seek accreditation as per IAF Code 34 ; NACE Code 71 which addresses the Inspection of Buildings activities

At the moment NABCB Accredited IBs with above IAF Scope are not found NABCB Registry. Few IBs may seek Accreditation under above scope to cater to the requirement specified by NABH in future. Healthcare organisations have to refer NABCB’s Registry for more updates on the accredited IBs list.

It’s a good move to encourage healthcare businesses to show compliance and adherence to Regulatory, Statutory requirements by offering Safety and Assurance to the users of healthcare facilities and Employees as well.

NABH – Notification – 3rd Edition of NABH Standard

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.

source: NABH/Notification/SHCO/3rd Edition/Imp/2022/7379 dt 7.9.22

Notified Bodies registered with CDSCO under MDR 2017

List of Notified Bodies registered with CDSCO under MDR 2017

CDSCO has released the list of Notified Bodies registered with CDSCO under Medical Devices Rules 2017 to carry out audit of manufacturing site under the provisions of said rules.

Please click the link below to know the list of registered Notified Bodies

Call for ePosters – by Asian Society for Quality in Health Care (ASQua)

World Patient Safety Day 2022 – Poster Competition – invite by ASQua

Asian Society for Quality in Health Care (ASQua) commemorates World Patient Safety Day 2022 with a webinar on 19/Sep/2022 (Monday) at 3:30 pm IST.

Prof.Jeffrey Braithwaite, President, ISQua will provide the Keynote address followed by Speakers from Taiwan, Japan and India deliberating on the WHO Strategic Framework of the Global Patient Safety Challenge. Results of the e-Poster competition conducted will also be announced.

ASQua invites you to submit your poster abstracts under the following tracks to commemorate the theme of WPSD 2022: Medication Safety – 19th September, 2022

  1. Technology to prevent medication harm
  2. Innovative practices in preventing medication harm

Please email your poster to asqua@asquaa.org and make sure the following info included in your email subject:

  1. The event title “2022 WPSD poster”
  2. Main presenting author’s full name
  3. Abstract title

Submission Guidelines (link)

Submission Opens :5th August 2022
Submission Deadline :5th September 2022
Eposter template (www.asquaa.org/wpsd2022)
Submit Abstract to asqua@asquaa.org
Registration Information (www.asquaa.org/wpsd2022)
The link to register for the FREE webinar – https://forms.gle/p7uEzbzjUrPeiTQ78
Notification about acceptance or rejection will be delivered via email to the submitter by 19th September 2022.

All ePosters will be made available on the online ePoster platform of ASQua.

For any additional queries,

Contact
Mr. Saifulhazmi Bin Salihin
Secretariat
Email: asqua@asquaa.org

Frequently Asked Questions ( FAQs) on Medical Device Rules, 2017

CDSCO has released a document on Frequently Asked Questions on Medical Device Rule, 2017

Central Drugs Standard Control Organization (CDSCO) . Directorate General of Health Services, Ministry of Health and Family Welfare, has released a Document on FAQs on Medical Device Rule 2017, to create public awareness about Medical Devices Regulation.

Source : Doc No.: CDSCO/FAQ/MD/01/2018
https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadImmunization/FAQmd2018.pdf

Advisory on Medical device Standards

Public Notice on Medical Devices Standards from Department of Pharmaceuticals

Public notice on Medical Devices from Department of Pharmaceuticals on what Standards industry and stakeholders have to follow, refer while dealing with Medical Devices.

Medical Device Sector is brought under 100% Regulation which means that it’s well defined framework , structure and has well established regulatory protocols .

Healthcare Services should understand more about the Supply Chain Quality – understand the Regulations, Standards , Certifications , Testing , Inspection norms that are prescribed for the market players.

Unless the supply chain quality is understood correctly, Service providers delivery can’t have the necessary assurance to users .

Procurement teams, QA teams in healthcare services should know about National, International Conformity Assessment practices, norms for Healthcare Products.

Since Users, Patients, stakeholders etc are always seeing Global Quality Campaigns while introducing, prescribing Products, it’s important to respond to queries on the same when asked.

Source: Public Notice No.31026/83-2021-MD dt. 01.02.2022 issued by Department of Pharmaceutical

Social Audit Standards issued by ICAI

Exposure Draft on Compendium of Social Audit Standards issued by ICAI

In order to regulate the profession of Social auditors, the Sustainability Reporting Standards Board of ICAI has developed the draft preface to the social audit standards as specified in the notification dated July 25, 2022 issued by SEBI .

“Securities and Exchange Board of India (Issue of Capital and Disclosure Requirements) (Third Amendment) Regulations, 2022” dated July 25, 2022, has been issued in The Gazette of India regarding formation of Social Stock Exchange . The notification defines Social Stock Exchange as “A separate segment of a recognized stock exchange having nationwide trading terminals permitted to register Not for Profit Organizations and/ or list the securities issued by Not-for-Profit Organizations in accordance with provisions of these regulations.”

As per the above notification, The Institute of Chartered Accountants of India (ICAI) has been entrusted with the responsibility of being Self- Regulatory Organization for regulating the profession of Social auditors

In this regard, Sustainability Reporting Standards Board of ICAI has developed following :

• (i) Draft Preface to the Social Audit Standards
• (ii) Draft Framework for the Social Audit Standards
• (iii) Draft Social Audit Standards (SAS) on all the sixteen thematic areas specified in the above mentioned notification.

The downloadable version of the Exposure Draft is available at: https://resource.cdn.icai.org/71191srsb57193.pdf
Comments on this exposure draft are sought by ICAI latest by August 26, 2022

  1. Electronically Click on https://forms.gle/eFUnUZcXFzJzyCRC7 to submit comment online (Preferred method)
  2. Email: Comments can be sent to: sustainability2022@icai.in

Source: https://www.icai.org/post/srsb-ed-compendium-of-social-audit-standards-for-comments

Heal in India

Heal in India – Govt plans interpreters, special desks at 10 airports for ease of overseas patients

‘Heal in India’ – Government is likely to announce the initiative on August 15 2022.

The ‘Heal in India’ initiative aims to positioning the country as a global hub for medical and wellness tourism.

Interpreters and special desks at 10 airports, a multi-lingual portal and simplified visa norms are going to be the highlights of the government’s ‘Heal in India’ initiative to boost medical tourism.

The government has identified 44 countries, predominantly African, Latin American, SAARC and Gulf countries from where a large number of people visit India for medical purposes. The 10 identified airports — Delhi, Mumbai, Chennai, Bengaluru, Kolkata, Visakhapatnam, Kochi, Ahmedabad, Hyderabad and Guwahati — see higher footfalls of patients from these 44 countries

The Health Ministry, in collaboration with the National Health Authority, has developed a multi-lingual portal which would be a one-stop shop for services provided by medical travel facilitators and hospitals with an interface for foreign patients. The portal is also likely to be launched on August 15.

The portal will display standardized package rates based on the classification of hospitals and different systems of medicines including modern and traditional systems. It will also have a grievance redressal section as well as an option to submit patient feedback.

There will also be a mechanism to track patient journey by creating a unique health ID under the Ayushman Bharat Digital Mission framework and monitor service delivery in identified health facilities in India

Source:https://m.timesofindia.com/business/india-business/heal-in-india-govt-plans-interpreters-special-desks-at-10-airports-for-ease-of-overseas-patients/articleshow/93408941.cms

NHA Joins hands with QCI to Accredit ABDM Compliant Healthcare Solutions

National Health Authority (NHA) joins hands with Quality Council of India (QCI) to accredit ABDM compliant healthcare solutions like HMIS/LMIS

The National Health Authority (NHA) has onboarded the Quality Council of India (QCI) for six months to accredit and rate HMIS (Health Management Information System)/ LMIS (Laboratory Information Management System) solutions that have integrated with Ayushman Bharat Digital Mission (ABDM).

NABH will undertake the responsibility of accrediting and rating the ABDM compliant solutions on various parameters, including ease of usage, user interface, pricing, number of modules/features and value for money/pricing so that prospective purchasers may get credible information.

The purpose of this initiative is to encourage innovations by streamlining delivery of health tech services in a significant way. To develop a framework to ensure that ABDM compliant digital healthcare solutions are accredited and rated and to adequate information is available to consumers for choosing one solution over another.

Accredited health tech solutions will help healthcare organizations manage their patient journeys and business more methodically in accordance with ABDM standards. And ultimately, this initiative will help the citizens of India get better and more timely healthcare and help India become one of the leaders in digitization of healthcare in the world”

This accreditation exercise will be conducted in a phased manner. Phase I shall focus on accreditation and rating of HMIS solutions successfully integrated with ABDM. Subsequent phases shall include other subjective parameters and other categories of healthcare solutions like LMIS, Health Lockers, Health Tech,PHR (Personal Health Records) apps etc.

Source : Posted On: 04 AUG 2022 6:12PM by PIB Delhi

Pharma Sector Global Standards

Government of India launches scheme for pharma sector to step up capacity, upgrade to global standards

Move from Volume to Value

Support to Pharma clusters and MSME units to enhance quality and technology improvement

In the launch event of DoP’s Strengthening of Pharmaceuticals Industries – Dr. Mansukh Mandaviya, Minister for Chemicals & Fertilizers and Health & Family Welfare urges the Pharma Industry to make India a global leader in pharma sector and utilize the scheme to upgrade MSMEs to high standards.

On July 21, 2022, Dr. Mansukh Mandaviya, Minister for Chemicals & Fertilizers and Health & Family Welfare formally launched the scheme of Strengthening of Pharmaceuticals Industries at Dr Ambedkhar International Convention Centre, Janpath, New Delhi, in the presence of  Minister of State for Chemicals & Fertilizers and New & Renewable energy Shri Bhagwanth Khuba amidst the strong presence of pharma MSME industry players and representatives of major Pharma Associations. 

The initiatives under the scheme are aimed at further enhancing India’s capabilities in the pharmaceuticals sector with an objective to make it much more competitive in terms of both quality and cost and also aimed at making Indian pharma MSMEs, a part of Global supply chain by incentivizing them to acquire Schedule M and WHO GMP certifications.

The Scheme provides for credit linked capital and interest subsidy for Technology Upgradation of MSME units in pharmaceutical sector, as well as support of up to Rs 20 crore each for common facilities including Research centre, testing labs and ETPs in Pharma Clusters. SIDBI will be the Project management Consultant for implementing the scheme.

The Chemicals and Fertilisers Ministry rolled out the schemes under the banner of ‘Strengthening Pharmaceuticals Industry’ (SPI). SIDBI will be the project management consultant for implementing the scheme

Union Minister for Chemicals and Fertilisers Mansukh Mandaviya said the schemes envisage technology upgradation, setting up of common research centres and effluent treatment plants in clusters for the pharma MSMEs and Small companies should be able to upgrade their facilities to global manufacturing standards.

The scheme has three components:

 Assistance to Pharmaceutical Industry for Common Facilities (APICF) – would strengthen the existing pharmaceutical clusters’ capacity for sustained growth. It provides for an assistance of up to 70 per cent of the approved project cost or Rs 20 crore, whichever is less.

 Pharmaceutical Technology Upgradation Assistance Scheme (PTUAS) – would facilitate pharmaceutical MSMEs with proven track record to upgrade their technology. The scheme has provisions for a capital subsidy of 10 per cent on loans up to a maximum limit of Rs 10 crore with a minimum repayment period of three years or interest subvention of up to 5 per cent (6 per cent in case of units owned by SC/ST) on reducing balance basis

 Pharmaceutical and Medical Devices Promotion and Development Scheme (PMPDS), would involve preparation of study reports on topics of importance for the Indian pharma and medical device industry. The scheme is aimed at creating a database of pharma and medical device sectors

Information Source : https://www.moneycontrol.com/news/trends/current-affairs-trends/government-launches-scheme-for-pharma-sector-to-step-up-capacity-upgrade-to-global-standards-8862561.html

https://pib.gov.in/PressReleaseIframePage.aspx?PRID=1843560