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.

Customers Quality Systems – Supply Chain getting Trained

Orientation Program for IVD Manufacturers about Various Quality Systems Programs implemented by their User Industry – Hospitals, Med Labs , Other Healthcare Organisations

Supply Chain is showing interest to learn about various Quality Systems implemented by their Customers

Customers Quality Systems – Supply Chain getting Trained

Got a call from an IVD Manufacturer last week expressing interest to get his team trained on various Quality Management Systems followed by healthcare organisations.

I first thought I heard it wrong, I thought he was seeking training for his team on Med Dev QMS. When I asked the question, he said NO and his question is about getting his team members understand a little about various QMS Programs implemented by their customers like NABL, NABH , CAP, QAI Programs.

I was a little surprised and asked him for the reason for choosing a topic like this, though I could quickly guess where he would be heading to. He has mentioned that they are supplying their products to multiple categories of healthcare organisations . Each one comes up with some Certification, Accreditation program that they are implementing. Having implemented Med Dev QMS & Product Certification Programs in house, he felt that its appropriate for his team to acquire some basic knowledge about their Customers Quality Systems Programs and ensuring that as Vendors to the respective healthcare orgns, they would prefer to provide necessary inputs, information that are needed by these Healthcare Organisations (HCOs) during their Quality journey.

This is what is emerging across the globe. Many businesses / sectors are ensuring that their Supply Chain is also in sync with their Quality Systems Journey. When a Mfrer or a Service Provider delivers a Product or a Service to end user / customer, as a finished good, he/she has to doubly ensure that his supply chain also maintains high Quality Standards. It becomes imperative for the Vendors, Suppliers , Stakeholders who are part of the supply chain to be in sync, in alignment with the Quality Systems adopted by their customers.

Similarly, businesses that are seeking support from suppliers, should also make an effort to understand the Quality Systems – be it Product or Systems Certifications, implemented by the Suppliers in their respective organisations. This is the fundamental requirement of Vendor Evaluation in any business. Understanding the Suppliers Quality Systems Programs Matters for Businesses too ! Many Regulated Business Sectors, across the globe, have initiated this exercise of bringing the Supply Chain under some Quality Standards, Systems Programs. Automotive Sector was the 1st sector to introduce this almost 2 decades ago. Many other sectors which are under Regulatory Control are slowly introducing this concept.

This manufacturers/suppliers, being the suppliers to many healthcare organisations, come under the supplier category to these businesses. Healthcare Sector being regulated (be it Products or Services) in the country now, Supplier Quality Compliance will become a norm sooner or later.

We have customised a 3 day program for the IVD Mfrer’s team comprising of :
– Technical Team
– Sales Team
– Customer Support Team
– Management Team

The program was designed in such a manner to provide them a bird’s eye view on various Healthcare Certification, Accreditation Programs that are currently available in India for healthcare businesses to choose.

We have also designed a session on Minimum Standards that are adopted in the country as Regulatory spec which addresses basic QMS to be implemented by Med Labs in the country.

It was interesting session fielding questions from IVD Mfrers about Quality Systems Programs in HCOs.

  • Some interesting questions posed by them :
  • For a start up lab, Is there a bare minimum period required to get the accreditation, if all the criteria is met?
  • Is there any minimal number of parameters in scope of testing for applying certification ?
  • What is the difference betn Certification & Accreditation Program when most of the quality mgmt systems clauses are similar ?
  • Is it compulsory to do ILC ? Frequency ?
  • When there are multiple Certification , Accreditation Programs available for Med Labs, how to differentiate and choose a relevant, appropriate program for HCO

Matured Participants and the Quality of the interactions was highly invigorating .

Were actually surprised when they were asking questions related to :
– Voluntary withdrawal from Accreditations :
– Suspensions criteria
– Eligibility of the HCOs to reapply
– Normal scenarios , reasons for such actions taken by Accreditation Bodies
– Any penalties , punishments for non compliances

Some screen shots from the session :

3 days of orientation program came to a close today. Bird’s eye view of all National , International Certification, Accreditation Programs , Minimum Standards – Regulatory requirements were covered. Program was well received and appreciated by the participants.

Informative, customised content, pretty detailed, well explained, looking forward to detailed sessions

Some feedback received by the end of the session.

Moving forward, Quality Systems Implementation Programs become more inclusive in nature in near future. Businesses will ensure Quality of their Supply Chain and Suppliers will show more interest to learn about their Customers Quality Systems Implementation Programs. More inclusive it becomes, supply chain gets strengthened and end users will be assured of better Quality & Safe Products and Services.

Session was handled by :
Dr Srivatsan , Expert – Healthcare Quality Management Systems
A A Srinivasan – Principal Consultant
Chithambaranathan – Associate Consultant

Posted by :

Rama Venugopal
Executive Director
Value Added Corporate Services P Ltd
Click Here for More Updates

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

Pharmacovigilance in Hospitals

Reporting of Adverse Drug Reactions (ADRs) in Hospitals in India

Dr Srivatsan Bashyam, Principal Consultant

Email: srivatsan@valueadded.in

Virtual Training on Pharmacovigilance for NABH Accredited Hospitals was conducted by IPC – Indian Pharmacopoeia Commission , recently to create an awareness on Pharmacovigilance and Reporting of adverse drug reactions (ADRs).This write up prepared is based on the training given by IPC Team and various experts like Dr. Jai Prakash  Officer-in-Charge, PvPI, Mr Prashant Paschal, Assistant Director NABH QCI New Delhi, Dr. Vandana Roy AMC Coordinator MAMC-New Delhi, Dr. Rahul Shukla AMC Coordinator Yashoda Super Speciality Hospital, Kaushambi,  Ghaziabad  and my own search from various sources.

Pharmaceutical medicines are designed to cure, prevent or treat diseases; however, no medicine is without side effects and there are also risks particularly adverse drug reactions (ADRs) which can cause serious harm to patients.

It is been reported that adverse drug reactions (ADRs) are poorly reported in developing country including India. It is estimated that only 2-4% of adverse drug reactions (ADRs) are reported and only 10% of serious adverse drug reactions are reported world wide.

Pharmacovigilance (PV) plays a key role in the healthcare system through assessment, monitoring and discovery of interactions amongst drugs and their effects in human and helps in to reduce the harm to future patients.

What is ADR:

The World Health Organization defines an ADR as “any response to a drug which is noxious and unintended, and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function.”

In addition to Drugs the vaccines, Medical Devices, Biosimilars, Diagnostic Agents are considered for ADR.

Classification of ADR:

Adverse drug reactions are classified into six types (with mnemonics):

Type A :dose-related (Augmented), 
Type B : non-dose-related (Bizarre),
Type C : dose-related and time-related (Chronic),
Type D : time-related (Delayed),
Type E :withdrawal (End of use),
Type F : failure of therapy (Failure).

A simple and common method of classifying ADRs is to divide them into two types – Type A and Type B. This is also known as the Rawlins–Thompson classification.

REACTIONTYPE A ‘AUGMENTED’TYPE B ‘BIZARRE’
Pharmacologically predictableYesNo
Dose-dependentYesNot clearly
IncidenceCommonUncommon
DetectionEarly in clinical developmentPost-licensing
MortalityLowHigh
ManagementReduce doseDiscontinue therapy

Who are at Risk of ADR :

  • Elderly

Patients taking medication from specific classes like –

  • Anti diabetics and Hypoglycemic Agents
  • Cardiovascular Drugs
  • Psychotropic Drugs
  • Anticonvulsants
  • Antineoplastic
  • Corticosteroids

Reporting of ADR:

All healthcare professionals (clinicians, dentists, pharmacists, nurses) and patient/consumers can report ADRs to National Coordination Centre (NCC) or Adverse Drug Reaction Monitoring Centres (AMC).There are around 34 AMC centers in India. The pharmaceutical companies can also send individual case safety reports for their product to NCC.

Suspected ADR reporting forms for healthcare professionals and consumers are available on the website of IPC to report ADR. To remove language barrier in ADR reporting, the consumer reporting form are made available in 10 vernacular languages (Hindi, Tamil, Telugu, Kannada, Bengali, Gujarati, Assamese, Marathi, Oriya, and Malayalam). ADRs can be also reported via PvPI helpline number (18001803024) on weekdays from 9:00 am to 5:30 pm.The mobile Android application for ADR reporting has also been made available to the public.

Analysis of ADR:

There are many methods to analyze the ADR the most acceptable method is The WHO-UMC causality criteria.

The WHO-UMC causality criteria [WHO].

CausalityConditions (all conditions need to be complied with for each causality criterion)
CertainEvent/laboratory test abnormality with plausible time relationship to intake of a drug
Cannot be explained by disease or other drugs
Response to withdrawal plausible
Event definitive pharmacologically or phenomenologically
Rechallenge satisfactory, if necessary
ProbableEvent or laboratory test abnormality, with reasonable time relationship to drug intake Unlikely to be attributed to disease or other drugs
Response to withdrawal clinically reasonable
Rechallenge not required
PossibleEvent or laboratory test abnormality, with reasonable time relationship to drug intake Could also be explained by disease or other drugs
Information on drug withdrawal may be lacking or unclear
UnlikelyEvent or laboratory test abnormality, with a time to drug intake that makes a relationship improbable
Disease or other drugs provide plausible explanations
Conditional/ unclassifiedEvent or laboratory test abnormality
More data for proper assessment needed, or
Additional data under examination
Unassessable/ unclassifiableReport suggesting an adverse reaction
Cannot be judged because information is insufficient or contradictory
Data cannot be supplemented or verified

How to make the Hospital Adverse Drug Reaction Monitoring Centres (AMC):

The Hospital can send letter of intent to INDIAN PHARMACOPOEIA COMMISSION.
National Coordination Centre – Pharmacovigilance Programme of India (NCC-PvPI),MINISTRY OF HEALTH & FAMILY WELFARE, GOVERNMENT OF INDIA
SECTOR-23, RAJ NAGAR, GHAZIABAD- 201 002.
Tel No: 0120- 2783392, 2783400, 2783401, Fax: 0120-2783311
e-mail: pvpi.ipc@gov.in, lab.ipc@gov.in, Web: www.ipc.gov.in

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.

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

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.

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 :