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:-
| Comments | Decision |
| A1 – biomedical waste management rules, 2018 | Change as Biomedical waste management rules, 2018 as amended from time to time. |
| A2 – clinics to be made disabled friendly | Add the comment “as disabled friendly as possible” (desirable). |
| A3- rehabilitative services intended | For 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 speciality | Rejected |
| A5- services to be mentioned | Accepted 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 council | Accepted to use “pharmacy council of india”. |
| A8-in the minimum standard documents of clinic/polyclinic | Include 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 specific | Accepted 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 supervision | Rejected 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 experience | Accepted 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 specified | Minimum 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 desirable | A 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 1 | Remove 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:
- Health Checkup Centre
- Integrated Counselling Centre
- Dietetics
- Hospital (Level 1)
- Hospital(Level 2)
- Hospital(Level 3)
- Mobile Clinic Only Consultation
- Mobile Clinic With Procedure
- Mobile Dental Van
- Physiotherapy Centre
- Clinic/Polyclinic Only Consultation
- Clinic/Polyclinic With Diagnostic Support
- Clinic/Polyclinic With Dispensary
- Clinic/Polyclinic With Observation
- Collection Centres
- 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.
- 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.
- It was reiterated that only the registered clinical establishments can provide online diagnostic services, as already decided during the 12th meeting
- 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.
- 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.
- 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.
- 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.
- BMW (Biomedical Waste Management) Rules should be written as amended from time to time.
- It should be mentioned and displayed clearly whether the clinic/ hospital is disabled friendly or not.
- “Accessibility of specially-abled persons in minimum standards of hospitals” shall be included as mandatory requirement.
- Paramedical Staff should be referred to as “ALLIED HEALTH PROFESSIONAL”.
- 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.
- 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.
- 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.
- ABHA id for each patient to be facilitated by the Clinical Establishment (desirable).
- The signages for directions should preferably be placed only inside the hospital premises
- If a patient is to be transferred to higher/other hospital, the ambulance facility should be provided by the referring hospital.
- The doctors working in a hospital should be available on call.
- 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.
- Minimum qualification of Multi-tasking staff should be 10th pass.
- 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.
- 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.
- 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.
- 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.
- 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.
- Dr. Ram Niwas Meena, Joint Director, DHS, Rajasthan stated that they will constitute committee and will finalize the rates for laboratory investigations.
- 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.
- Pending actions as per the minutes of the 12th meeting may be completed at the earliest, as the National Council confirmed the minutes