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 byNABH, 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.
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 NABHQCI 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.
Patients taking medication from specific classes like –
Anti diabetics and Hypoglycemic Agents
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.
There are many methods to analyze the ADR the most acceptable method is The WHO-UMC causality criteria.
The WHO-UMC causality criteria [WHO].
Conditions (all conditions need to be complied with for each causality criterion)
Event/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
Event 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
Event 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
Event or laboratory test abnormality, with a time to drug intake that makes a relationship improbable Disease or other drugs provide plausible explanations
Event or laboratory test abnormality More data for proper assessment needed, or Additional data under examination
Report 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: firstname.lastname@example.org, email@example.com, Web: www.ipc.gov.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.
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.
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.
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
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 capturesthe 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 firstname.lastname@example.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 –
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.
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.
Fire Safety training during induction and regular training of existing staff is mostly lacking in many Healthcare organizations.
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 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.
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 :