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