Minutes of Meeting – CEA

Minutes of 13th Meeting of National Council for Clinical Establishment

Key Points from the recent meeting are shared below:

So far National Council has approved minimum standards for 15 major general categories and 34 specialty and super-specialty categories of clinical establishments/departments and all 7 recognized systems of AYUSH.

Standard Treatment Guidelines (STGs) for 227 medical conditions in Allopathy, 18 medical conditions in Ayurveda & 100 medical conditions in Siddha have been finalized and issued for implementation under the Act. MoHFW had invited public comments on the last draft of minimum standards and after this more than 20,000 comments were received. After considering the comments, the finalized drafts have been circulated for approval of the National Council.

The minutes of the 12th meeting were confirmed and it was noted that some actions of 12 meeting are pending.

After discussions and deliberations, by the National Council members and other participants, the following agenda wise actions were recommended/ decided:

1. Decisions in respect of the specific experts and public comments received on the draft minimum standards in respect of general category

Clinical Establishments are summarized as given in the table under:- 

CommentsDecision
A1 – biomedical waste  management rules, 2018Change           as        Biomedical     waste management rules, 2018 as amended from time to time.
A2 – clinics to be made disabled  friendlyAdd the comment “as disabled friendly as possible” (desirable).
A3- rehabilitative services intendedFor clinic or poly-clinic, healthcare services of rehabilitative nature may be provided as required and appropriate human resourse and equipment will be provisioned the same may be mentioned in the minimum standard (this will be a desirable).
A4- anesthesiology may be mentioned along with surgical specialityRejected
A5- services to be mentionedAccepted for inclusion of optometry, psychology, counseling, physiotherapy, audiology, speech pathology, dietetics and nutrition among others.
A6-refrain from using “paramedic”Accepted to use “allied healthcare professional” in place of “paramedic”.
A7- pharmacy councilAccepted to use “pharmacy council of india”.
A8-in        the        minimum         standard documents of clinic/polyclinicInclude the following statement (as support staff is different from other professionals providing services) –     “Include services provided by healthcare professionals (other than doctors/specialists) or allied health professionals shall be in consonance with their qualification, training and registration as per their respective councils”.
A9-role of health professional need to be clear and specificAccepted Medicine prescription may be issued by a qualified doctor on the basis of which a qualified pharmacist may dispense the drugs. However, a doctor can dispense drugs/medicines in a single clinic for his own prescription.  
A10- The statement must be reframed as – The availability of support staff is essential to ensure safe observation or short stay facility. (As per the WHO-ISCO- 08 mapping of workforce, support personnel is distinct category and include a wide range of other types of health systems personnel, such as health service mangers, medical secretaries, ambulance drivers, building maintenance staff, and other general management, professional, technical, administrative and support staff. Nursing may not be considered as support staff; In the current scenario, they have increasing responsibilities that may have handled independently under doctor’s orders; hospital general duty assistants, orderlies, housekeeping etc. come in the
category of support staff)
Accepted  
A11- Consider reframing the statement as – Duty rooms for technologist and assistants(technician)Accepted with following modification: Duty rooms for health support staff (desirable), however no beds will be provided, resting chairs may be provided
A12- To be rephrased as – The technologists should have the relevant education or registration, training and experience to provide service to customer care without supervision and assistants (technicians) should work under their direct supervisionRejected
Add     qualification   to        be        as per guidelines
A13- Consider reframing this to reflect (refrain from using the term Paramedic – across the document) – 1.3 Allied and Healthcare Professionals
1. Category: Allied and Healthcare
Professionals
Accepted to use “allied healthcare professional” in place of
“paramedic”all designations of allied health staff shall be used as provided under the National Commission for Allied and Health Care Professions Act, 2021
A14- ECG Technician(to be called as
ECG Technologist) ECG Technology Diploma holder with 1 year of experience in operating ECG machine
Accepted to use “ECG Technologist” as provided under the National Commission for Allied and Health Care Professions Act, 2021
A15- Laboratory Technician – to be called as Medical Laboratory Technologist – minimum Degree holder in Medical Laboratory Science or Diploma holder with two years of experienceAccepted to use “Medical Laboratory
Technologist” as provided under the National Commission for Allied and Health Care Professions Act, 2021.
A16-      To      be      called      as      Health
Information Management Assistant- Minimum Diploma holder with no experience.
Accepted to use “Health Information Management and Health Informatic Professional” as provided under the
National Commission for Allied and Health Care Professions Act, 2021
A17- may also be called as Medical
Radiology and Imaging Technologist
(MRIT)-           minimum          qualification
Bachelor degree in Radiology and
Imaging Technology/Junior MRIT if a
Diploma Holder
Accepted to use “Medical Radiology and Imaging Technologist (MRIT)” as provided under the National Commission for Allied and Health Care Professions Act, 2021..
A18- The services offered may also include one or more than one specialty of allopathy medicine, AYUSH, Dental, wellness, etc. and allied services like Physiotherapy in the mobile clinic.Accepted as The services offered may also include one or more than one specialty of allopathy medicine, AYUSH, Dental, Physiotherapy,
wellness, etc. and other services in the mobile clinic.
A19- Given the dearth of specialists, it is highly unlikely that a mobile clinic will be manned by a specialists or super specialist medical practitioner. Accordingly, the statement may be modified to reflect ‘general practitioner or a higher qualified medical
practitioner…’
Rejected
A20- The services offered may also include one or more than one specialty of allopathy medicine, AYUSH, Dental, wellness, etc. and allied services like Physiotherapy in the mobile clinic.Accepted as The services offered may also include one or more than one specialty of allopathy medicine, AYUSH, Dental, Physiotherapy,
wellness, etc. and other services in the mobile clinic
A21- The general practitioner or specialist doctor or super-specialist doctors as per the scope of the clinic or polyclinic shall be registered with State or Central Medical Council of
India
To be rephrased as – The general practitioner or a higher qualified medical practitioner as per the scope of the mobile clinic shall be registered with State or Central Statutory Council, as applicable.
A22- The clinic or polyclinic shall have
essential equipment as per
To be rephrased as – The mobile clinic shall have essential equipment as per.
A23- Minimum qualification must be specified – Diploma in Pharmacy or B.
Pharma
The qualification of Pharmacist shall be as per Pharmacy Council of India or the State Pharmacy Council.
A24- Revised nomenclature be used
(refrain from using ‘technician’) (throughout the document wherever applicable)
A25- Junior Medical Radiology and Imaging Technologist
(throughout the document wherever applicable)
The nomenclature of the allied health professionals shall be as per the National Commission for Allied and Health Care Professions Act, 2021. 
A26- Minimum qualification of multitask staff may be specifiedMinimum qualification of the multitask staff should be 10th Pass
A27- Human Resources must be specified as per the IPHS or at the minimum the following must be
included in the existing list –
– As there is stress on the information management and medical records – a Health Information Management
 – Assistant(Diploma              holder/ Technologist (BSc degree holder)
– OT Assistant (Diploma holder/ Technologist (Bachelor degree holder)
Add the comment “as desirable”
3.1.1- The Hospital shall display appropriate signage which shall be in at least two languages. A board stating “24 hours emergency available” is desirableA board stating “24 hours emergency available” is mandatory”.
3.1.3- The directional signages should be permitted outside in the nearby vicinity of the hospital or Nursing Home to facilitate easy access.To be Deleted
7.5- The Hospital shall arrange transportation of patients for transfer or referral or investigations etc. in safe manner. The arrangement can be out sourced or self-owned.Add “ mandatory”
APPENDIX 1Remove Desirable at all places
APPENDIX 5 Human Resource, Point
No. 7
Add       comment      “Doctor      shall
available on call “ Remove Desirable
APPENDIX 5 Human Resource, Point
No. 8
Remove Desirable
APPENDIX           6       List        Of          Legal
Requirements, Point No. 3
Remove “As per AERB regulations”
APPENDIX 8 Patients’ rights and
responsibilities
To be included in minimum standards of all Clinical Establishments and will be applicable in line with the facilities/services provided by the Clinical Establishments
A28- Specify the services envisioned under the said discipline – such as
Physiotherapy Audiology etc. Equipments and modalities to be adequately specified in the Equipment Appendix – 3 Also revise the HR as applicable Appendix 5
Add comment “ as per services offered”

Based on the above decisions the respective minimum standards, 15 general category clinical establishments, as given under, may be finalized after incorporating the above mentioned changes as given in the table and the decisions taken during this meeting:

  1. Health Checkup Centre
  2. Integrated Counselling Centre
  3. Dietetics
  4. Hospital (Level 1)
  5. Hospital(Level 2)
  6. Hospital(Level 3)
  7. Mobile  Clinic Only Consultation
  8. Mobile  Clinic With Procedure
  9. Mobile Dental Van
  10. Physiotherapy Centre
  11. Clinic/Polyclinic Only Consultation
  12. Clinic/Polyclinic With Diagnostic Support
  13. Clinic/Polyclinic With Dispensary
  14. Clinic/Polyclinic With Observation
  15. Collection Centres
  1. It was decided that the above mentioned minimum standards, after the aforesaid changes are approved, and may be taken up for the notification in the Gazette.
  2. The issue of fixing the upper limit of charges of facilities/services by the Clinical Establishments was discussed. It was recommended that this would be done in a stepwise manner. The costing of diagnostic procedures should be done first.
  3. It was reiterated that only the registered clinical establishments can provide online diagnostic services, as already decided during the 12th meeting
  4. Issues related to Dental Clinical Clinical Establishments namely practice by dental hygienist, signatory authority of Oral Pathologist in Laboratory reports, dental maxillo-facial surgeon doing hair transplant may be discussed separately with DCI, IDA and Government Dental college experts.
  5. During the course of meeting Board of Ethics and registration, NCISMasked 01 month to furnish the comments related to categorization and minimum standards under Clinical Establishment Act in related to private clinics, therapy center, Panchkarma, ISM Nursing homes, ISM hospitals or any ISM specialization. This was agreed.
  6. For clinic or poly-clinic, healthcare services of rehabilitative nature may be provided as required and appropriate HR and equipment will be provisioned, the same may be mentioned in the minimum standard.
  7. JAN AUSHADI KENDRA should be setup within the hospital premises or outside at a strategic location for easy availability and accessibility of medicines to the poor population. The proposal in this regard may be framed by respective District/State Authority.
  8. BMW (Biomedical Waste Management) Rules should be written as amended from time to time.
  9. It should be mentioned and displayed clearly whether the clinic/ hospital is disabled friendly or not.
  10. “Accessibility of specially-abled persons in minimum standards of hospitals” shall be included as mandatory requirement.
  11. Paramedical Staff should be referred to as “ALLIED HEALTH PROFESSIONAL”.
  12. Issues related to Physiotherapy centre/Physiotherapists
    • These issues were discussed in detail and summary of discussions/action point recommended are given below:
    • Under the Clinical Establishments Act, 2010, in the Categorization of clinical establishments as approved by National council, profession of Physiotherapy has been included under the broad heading of Allied Health Professions.
    • Physiotherapy Professional has been listed in the Schedule of the National Commission for Allied and Healthcare Professions Act, 2021, wherein they have been allowed to practice independently or as a part of a multi-disciplinary team.
    • However, as per Section 2(c) of the Clinical Establishments Act, a Physiotherapist cannot own, control or manage a clinical establishment, while Govt. any trust, society or corporation or single doctor can own, control or manage the clinical establishments. Hon’ble High Court of Delhi has observed this as incongruous and has directed Secretary (HFW) to examine the issue. It was noted that there is a provision for the ‘Individual Proprietorship’ under the head “Ownership of the clinical establishment”, in the Application form for registration, which is available on the website of the Clinical Establishments Act, 2010, at the weblink:           http://www.clinicalestablishments.gov.in/AuthenticatedPages/cms/
    • After detail discussions and deliberations, National Council, representatives of State Councils and other participants were of the view that an amendment  in the Clinical Establishments (Registration and Regulation) Act, 2010 is necessary to remove the incongruity. Ministry of Health may consider the same in consultation with the stakeholders. 
  13. Issues related to Hair Tranplant Centres
    • It was informed that a sub-committee, under the chairmanship of DGHS, MoHFW has been constituted for drafting Minimum Standards for Hair Transplant Centres and the first meeting was held on 06.07.2022. The sub-committee was revised in pursuance to the directions of the Hon’ble high Court of Delhi, vide its Order dated 11.05.2022 and now a representative of Association of Hair Restoration Surgeons of India has been included. It was recommended that draft minimum standard for Hair Transplant Centre may be finalized by subcommittee and may be submitted in the next meeting of National Council for approval.
  14. It will be mandatory for every clinical establishment to issue prescription to patient for the treatment prescribed. Medicine prescription may be issued by a qualified doctor on the basis of which a qualified pharmacist may dispense the drugs/medicines. However, a doctor can dispense drugs/medicines in a single clinic for his own prescription.
  15. ABHA id for each patient to be facilitated by the Clinical Establishment (desirable).
  16. The signages for directions should preferably be placed only inside the hospital premises
  17. If a patient is to be transferred to higher/other hospital, the ambulance facility should be provided by the referring hospital.
  18. The doctors working in a hospital should be available on call.
  19. Patient information sharing by the hospital with the private &/or foreign company, shall not be allowed unless specifically permitted by patient or his family member.
  20. Minimum qualification of Multi-tasking staff should be 10th pass.
  21. DGHS stated that overcharging is one of the major issue related to high price of the drug and for various Medical/Surgical procedures and also some laboratory investigations, these should be controlled and regularized by adoption and implementation of Clinical Establishments Act 2010.
  22. According to Dr. Mira Shiva some private hospitals and corporate hospitals charging huge, they should be first controlled and regularized through Clinical Establishments Act 2010.Range of the charges should be fixed for private and corporate hospitals for various procedures, treatments and investigations.
  23. Bills for payments made must be issued by all clinical establishments to the patients for various charges paid by him. However single doctor clinic as of now may be exempted from giving bills, however it shall be applicable if specifically permitted by State Council.
  24. Regarding the apprehension of re-circulation of medicines in case of non utilization especially in ICU/CCU, the hospitals may be directed to return the packing material of such medicines and empty bottles/vials, etc. of used medicines costing above a specific price to the patients/attendants for their satisfaction. The price above which this is to be implemented may be decided by the respective States Councils.
  25. Dr. S. Tasso Kampa from Arunachal Pradesh stated that they have finalized rates for laboratory investigations. Dr. Anil Kumar, Addl. DDG added that these rates should be circulated to other STATES and UTs also for helping them in finalizing their rates.
  26. Dr. Ram Niwas Meena, Joint Director, DHS, Rajasthan stated that they will constitute committee and will finalize the rates for laboratory investigations.
  27. It was informed that a new Website of clinical establishments Act is under development which will have provisions for both online provisional and permanent registration, payment gateway, Online Grievance Redressal Mechanism and appeal mechanism. The home page of website was displayed during the meeting.
  28. Pending actions as per the minutes of the 12th meeting may be completed at the earliest, as the National Council confirmed the minutes

Healthcare Industry Update

Healthcare Industry Update

Outsourcing of human resources, including doctors, nurses, and other staff by applicant to clinical establishment is not exempt under “Healthcare Service”; Health care exemption is available only when the clinical establishment itself provides the service to the in-patients as well as out-patients and the same is not available when services are provided by a third party as a contractual arrangement

Parties – M/s ARPK Healthcare Private Limited

Facts –

  • The Applicant, M/s ARPK Healthcare Private Limited, is providing healthcare services to patients of M/s Asian Institute of Medical Science, Faridabad.
  • The Applicant is planning to enter into a contract with M/s Asian Hospital Pvt. Ltd. to supply human resources, including doctors, nurses, and other staff, for the gastroenterology department of the recipient.
  • The charges for healthcare services will be paid by patients to M/s Asian, who will pay the applicant for the services rendered.
  • The Applicant submitted that these charges will not be liable for GST as they are exempted from the levy of GST under entry number 74 of Notification No. 12/2017 -CENTRAL TAX (RATE) Dt 28/06/2017.

Issue –

  • Whether Fee/ charges received by the applicant from M/s Asian Hospital is exempted under the provisions of the GST Act?
  • Whether Fee/charges for Health Care Services received by M/s Asian is exempted under the provisions of the GST Act, 2017?

Order –

  • The authorities observed that the contract between M/s ARPK and M/s Asian Healthcare Pvt. Ltd. to supply human resources personnel services is a taxable event and not covered under exemption notification no. 12/2017-CT (R) dated 28 June 2017.
  • Although M/s Asian Hospital Private Ltd. provides healthcare services to patients through the doctors hired or outsourced by M/s ARPK, the outsourcing of infrastructure by M/s Asian Hospital to M/s ARPK Healthcare Private Ltd. is not covered under the definition of “Healthcare Service” under the notification.
  • The exemption claimed by the applicant is available under the notification only when the clinical establishment itself provides this service (treatment related to gastroenterological problems) as a part of health care services to in-patients and out-patients and the same is not available when such supply of services provided by a third party as a contractual arrangement.
  • In view of the same, the fee/ charges received by the applicant from M/s Asian is not exempt under GST.
  • Further, fee/ charges for health care services received by M/s Asian is exempt except for the services mentioned under heading 9993 clause no. 31A vide notification no. 03/2022 – CT(R) dated 13.07.2022.

Source:https://www.taxrealtime.in/posts/gst-aar-haryana-outsourcing-of-human-resources-including-doctors-nurses-and-other-staff-by-applicant-to-clinical-establishment-is-not-exempt-under-healthcare-service-health-care-exemption-is-available-only-when-the-clinical-establishment-itself-provides-the-service-to-the-in-patients-as-well-as-out-patients-and-the-same-is-not-available-when-services-are-provided-by-a-third-party-as-a-contractual-arrangement-order-attached/4#

Source:https://www.gstpress.com/caseLaws/ALL?caseLawId=clg0oynva118734007ogylqi01yi

Clinical Establishments Act

National Council for Clinical Establishments – Updated News

National Council for Clinical Establishments met recently and held discussions related to implementation of CEA and Minimum Standards.

Meeting was held to review the work done by the National Council so far, status of implementation of the
Act by the States/UTs and defining further Roadmap and consideration/decisions of specific agenda points.

Some of the key highlights of the meeting are captured below :

Hospitals

Inclusion of provision of mini oxygen plant/PSA plant and norms of oxygen availability as part of the minimum standards for hospitals for implementation under CE Act.

a. It was agreed that the primary focus should be to ensure availability of Oxygen as per requirement for all the services envisaged to be provided by the hospital. At least one third of total number of beds should be oxygen beds. Atleast 48 hours (preferably 72 hours) of oxygen of the total calculated oxygen requirement of the hospital should be available at any given time, as backup.

b. Oxygen requirement may be calculated as per the ME Division norms of oxygen cylinders based on Oxygen/ICU beds – NRBM/NIV/HFNC/Ventilator Bed capacity in the hospital for management of COVID-19, as mentioned in DO letter dated 21-6-2021 as at Annexure 1 c. Regarding the “establishment of Mini Oxygen Plants in hospitals and Clinical Establishments having more than 50 beds”, following action points were recommended:

i. Every new clinical establishment/hospital having more than 50 beds may be mandated to install Mini-Oxygen/PSA plants of appropriate capacity and specifications for their registration under Clinical Establishments Act, 2010.

ii. For the existing hospitals having more than 50 beds, a time period of 6 months (desirable) and 1 year (mandatory) may be given for compliance to the condition of installation of MiniOxygen/PSA plant.

iii. Accordingly it is recommended that this requirement may be included in the minimum standards for Hospitals and a notification in this regard may be considered to be issued by the MoHFW, as amendment to the Clinical Establishments (Central Govt ) Rules under the Clinical Establishments Act, 2010.

iv. The same advice as at points 3C (i), (ii) and (iii) above may be disseminated to the States/UT not covered by Clinical Establishments Act 2010 for enforcement under the respective State Clinical establishments Act or Disaster Management Act.

v. All small hospitals i.e 50 beds or less should also build infrastructure and add capacities to meet their oxygen requirements for the services envisaged to be provided by them, as per the type of the hospital.

vi. National Health Systems Resource Centre (NHSRC) is carrying out the revision of Indian Public Health Standards (IPHS) under NHM, accordingly they may clearly define oxygen requirements for various categories of hospitals ranging from 50 to 500 bedded in the revised IPHS guidelines.

Further NHSRC may define the capacity/specifications of equipment/ MiniOxygen/PSA plants to meet the oxygen requirement along with ensuring sustained Oxygen supply in Government Health facilities under NHM as a part of IPHS. They may consider defining the standards separately for difficult/remote/ inaccessible areas, if deemed necessary

Medical Testing Laboratories

Issues related to minimum standards for Medical Diagnostic Laboratories under the Clinical Establishments Act, 2010 (w.r.t suggestions received in respect of inclusion of PhD genetics and PhD scientists in minimum standards for Medical Diagnostic Laboratories)

The Council members were informed that the amended Gazette Notification in respect of Human resource requirements for Medical Diagnostic Laboratories has already been issued on 14-2-2020, which includes provision of MSc and MSc Phd with specified qualification and experience. They are permitted to conduct the tests, generate and sign test reports as authorized signatory for the specified types of tests of their domain area in the specified category of Laboratory, without recording any opinion or interpretation of the test results.

All such test reports generated must necessarily bear a disclaimer to the effect that the reports are strictly for the use of medical practitioners and are not medical diagnosis as such. The Gazette notification is available in public domain on the website of the Act. The participants endorsed the same.

The National Council approved the draft of Minimum Standards for Collection Centres, as finalized by the subcommittee and circulated with the agenda.

Online Health Portals :

The National Council considered the issue of regulation of online health services aggregator and related service providers under Clinical Establishments Act and their standards etc. It was noted that there is no specific provision for their regulation under the Act

a. The National Council endorsed the following recommendations of the “subcommittee for drafting standards for collection centre”

o Public to be made aware of such illegal online health aggregators

o Need to frame IT / Digital laws/rules to regulate them by the Ministry of Electronics and IT. Ministry of Health and Family may take it up with them and also consult Ministry of Law and Justice in this regard.

o The online Lab service aggregators and service providers should have a registration number and provide information regarding the lab where the samples are being sent for testing.

It was noted that a letter has been written by MoHFW to all States and UTs in this regard; however the respective States/UTs are required to take the necessary steps to regulate them.

It was recommended that all online service providers should have a linkage with the registered clinical establishments. Thus only a registered clinical establishment may be permitted to provide online services. MoHFW may issue necessary instructions to States /UTs in this regard. This may be enforced by the District Registering Authority at the district level and the State Council for clinical establishments at State level.

It was approved that a subcommittee under JS (Padmaja Singh), the Secretary of National Council may further examine the issue of regulation of online health aggregators in detail in consultation with stake holders and Law ministry, for taking appropriate action in the matter.

Patient Rights :

Inclusion of Additional Charter of patients’ rights in minimum standards.

The National Council for Clinical Establishments approved for inclusion of the following additional patient rights, as per NHRC Advisory, in the already approved list of patient rights.

Statutory Compliances

It was recommended to include AERB license as part of statutory requirements in the minimum standards as a pre-requisite for issuance of registration under CE Act, wherever applicable. Further it was approved to include AERB license in list of documents to be uploaded for grant of permanent registration to the clinical establishments, wherever applicable.

Full details of minutes covering list of Patient Rights and various other points discussed during the council meet, can be downloaded from 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.

Regulate Online Health Aggregators

Health Ministry Advisory to States, UTs

The Union Health Ministry has asked all states and UTs to implement a time-bound action plan for regulating online health service aggregators who have neither provided any details of laboratories on behalf of which they are providing services, nor their registration status, including compliance to minimum standards.

The ministry has further advised that the Department of Home of the state concerned may also be requested to investigate such matters with an objective to prevent any kind of violation (civil or criminal/cyber or otherwise) of applicable laws.

In a letter written to all states and UTs on January 19, Health Ministry Secretary Shri Rajesh Bhushan referred to an August 2020 order by the Delhi High Court which directed the ‘concerned authorities’ to initiate action against any illegal online health service aggregators operating in Delhi in violation of the ‘applicable laws’, including the Clinical Establishments (Registration and Regulations) Act, 2010.

Health Secretary said the laboratories and other clinical establishments, providing any type of medical services, are required to be registered either under the Clinical Establishments (Registration and Regulations) Act, 2010 (in those states/UTs where it is applicable) or under the state laws, as applicable.

This ministry has also notified in gazette, the minimum standards for laboratory services vide notifications dated May 21, 2018, and the amendment notification dated February 14, 2020, the letter stated.

Certain online health service aggregators, operational in various parts of the country, may perhaps be neither providing any details of laboratories, on behalf of which, they are providing services, nor their registration status, including compliance to minimum standards, Secretary said in the letter addressed to chief secretaries and administrators of all states and UTs.

The details of qualified staff, as required for running the laboratory services, may also not be available on their online portals.

“Health being a state subject, and keeping in view the directions of the Hon’ble Court in the above said order, it is requested, that a time-bound action plan may be made and implemented, as per the applicable laws, for regulating such online health service aggregators, and the related service providers, operational in your state/UT.

“It is further advised that the Department of Home of the state concerned may also be requested to investigate such matters with an objective to prevent any kind of violation (civil or criminal/cyber or otherwise) of applicable laws. It is further requested that an Action Taken Report may be sent to this Department on a priority basis,” the letter said.

Download the advisory issued by Dept of Health, MoH&FW