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U.P. Clinical Establishments (Registration and Regulation) Rules, 2016

U.P. Clinical Establishments (Registration and Regulation) Rules, 2016

Published vide Notification No. 191/2016/1625/5-6-2016-W-5/2002, dated 11.7.2016

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No. 191/2016/1625/5-6-2016-W-5/2002, dated 11.7.2016. - In exercise of the powers under sub-section (1) of section 54 of the Clinical Establishments (Registration and Regulation) Act, 2010 (Act No. 23 of 2010) the Governor is pleased to make the following rules:-

1. Short title and commencement. - (1) These rules may be called the Uttar Pradesh Clinical Establishments (Registration and Regulation) Rules, 2016.

(2) They shall come into force with effect from the date of their publication in the Gazette.

2. Application. - These Rules shall be applicable to such categories of clinical establishments as may be notified from time to time by State Government.

3. Definitions. - (1) In these rules, unless the context otherwise requires-

(a) "Act" means the Clinical Establishments (Registration and Regulation) Act. 2010 (Act no 23 of 2010);

(b) "Rules" means the Clinical Establishments (Central Government) Rules 2016;

(2) Words and expressions used and not defined in these rules but defined in the Act shall have the meanings respectively assigned to them in the Act.

4. The State Council for Clinical Establishments. - (1) With effect from such date as the State Government may, by notification appoint in this behalf, there shall be established for the purposes of the Act a council to be called the State Council of Clinical Establishments Uttar Pradesh.

(a) The Principal Secretary/Secretary, to the Government of Uttar Pradesh in Medical and Health Department who shall be the Chairperson, (ex officio)

(b) The Director-General, Medical and Health Service, Uttar Pradesh who shall be the Secretary.(ex officio)

(d) One representative each to be elected by the executive committee of-

(i) State Medical Council of India

(ii) State Dental Council of India

(iii) State Nursing Council of India

(iv) State Pharmacy Council of India

(e) Three representatives to be elected by the executive of State Council of Indian medicine representating the Ayurveda, Siddha and Unani systems of medicine,

(f) One representative to be elected by the State Council of the Indian Medical Association,

(g) One representative from the line of paramedical systems,

(h) Two representatives from State level consumer groups of reputed non-Governmental organizations working in the field of health,

(3) The nominated member of the State council, shall hold office for a term of three years, but shall be eligible for re-nominations for maximum of one more term of three years.

(4) The elected members of the State Council, shall hold office for three years, but shall be eligible for re-election;

Provided that the person nominated or elected, as the case may be, shall hold office for so long as he holds the appointment of the office by virtue of which he was nominated or elected to the State Council.

5. Functions of the State Council. - (1) The State Council shall perform the following functions, namely:-

(a) Compiling and updating the State Registers of clinical establishments;

(b) Sending monthly returns for updating the National Register (including in the digital format);

(d) Hearing of appeals against the orders of the authority;

(e) Publication on annual basis a report on the state of implementation of standards within States of Uttar Pradesh;

(f) Monitoring the implementation of the provisions of the Act and the rules made thereunder in the State;

(g) Recommending to the State Government, any modifications required to be issued in these rules in accordance with changes in technology or social conditions;

(h) Any other function as may be outlined by the National Council of Clinical Establishments and prescribed by the Central Government;

(i) Maintenance of standards within States of Uttar Pradesh, (2) It shall be the responsibility of the State Council for Clinical Establishment to compile and update the State Register of clinical establishments of the State and further to send monthly returns in digital format for updating the National Register.

6. Disqualification for appointment as member. - A person shall be disqualified for being appointed as a member of the State Council if he-

(a) has been convicted and sentenced for an offence which, in the opinion of the State Government, involves moral turpitude; or

(b) Is an undischarged insolvent; or

(d) has been removed or dismissed from the service of the Central Government or a State Government or a Corporation owned or controlled by any such Government ; or

(e) has in the opinion of the State Government, such financial or other interest in the State council as is likely to affect pre-judicially the discharge by him of his functions as a member.

7. Conduct of Business. - Every meeting of the State Council shall be presided over by the Chairperson and in the absence of the Chairperson the senior member of the State Council shall preside.

8. Time and place for meetings of the State Council. - The meetings of the State Council shall ordinarily be held at the State Capital on such dates as may be fixed by it. The State Council shall meet every three months.

9. Notice of Meeting. - Notice of every meeting other than a special meeting shall be dispatched by the Member Secretary to each member of the State Council not less than one week before the date of the meeting.

10. Quorum, call for meeting and minutes. - (1) One-third of the total number of members of the State Council shall form a quorum and all actions of the State Council shall be decided by a majority of the members present and voting.

(2) The notice and agenda of every such meeting of the State Council shall ordinarily be given 7-10 days before the meeting by the Member Secretary of the State Council.

(3) The proceedings of the meetings of the State Council shall be preserved in the form of minutes which shall be authenticated after confirmation by the signature of the Chairperson.

(4) A copy the minutes of each meeting of the State Council shall be submitted to the Chairperson by the secretary within 5-7 days of the meeting and after having been approved by him/her shall be sent to each member of the Council within 15 days of the meeting. If no objection to their correctness is received within 10 days of their dispatch, any decisions therein shall be given effect to;

Provided that the Chairperson may, where in his opinion it is necessary or expedient to do so, direct that action be taken on the decision of the meeting/

11. Resignation and filling of casual vacancies. - (1) A member desiring to resign his seat on the State Council shall send his resignation in writing to the Chairperson and every such resignation shall take effect from the date mentioned by him in this behalf or in case no such date is mentioned, from the date of the receipt of his/her letter by the Chairperson after confirmation from the member concerned about his resignation.

(2) When a casual vacancy occurs by reason of death, resignation or otherwise of a member, a report shall be made forthwith by the Chairperson to the State Government which shall take steps to have the vacancies filled by nomination election, as the case may be.

12. Finance and Accounts. - The Accounts of the Council shall be audited annually by a Chartered Accountant, who is to be appointed from a panel approved by the Comptroller and Auditor General of India. Any expenditure incurred in connection with such, audit shall be payable by the Council.

13. The District Registering Authority. - The State Government shall, by notification, under section-10, of the Act and in accordance with the rules farmed by central Government in this behalf set up an authority to be called the District Registering Authority for each district for registration of clinical establishments.

14. Functions of the Authority. - The Authority shall perform the following functions:-

(a) To grant, renew, suspend or cancel registration of any clinical establishment.

(b) To enforce compliance of the provisions of the Act and these rules;

(c) To investigate complaints of breach of the provisions of this Act or the rules made thereunder and take immediate action;

(d) To prepare and submit on quarterly basis report containing details related to number and nature of provisional and permanent registration certificates issued; include those cancelled, suspended or rejected to the State Councils;

(e) To report to the State Council on a quarterly basis on action taken against non-registered clinical, establishments operation in violation of the Act;

(f) Any other function as may be prescribed by the Central Government and or the State Government from time to time.

15. Powers of the Authority (section-10/2). - The authority shall, for the purposes of discharging its functions under the Act, have the same powers as are vested in a civil court under the Code of Civil Procedure, 1908, in respect of the following matters, namely:-

(a) Summoning and enforcing the attendance of any person and examining him on oath;

(b) Requiring the discovery and production of any document or other electronic records or other material objective producible as evidence;

(d) Requisitioning of any public record;

(e) Issuing commission for the examination of witnesses or documents;

(f) Reviewing its decisions, directions and orders;

(g) Dismissing an application for default or deciding it ex-parte;

(h) Any other matter which may be prescribed.

16. Meetings of the authority. - (1) The meetings of the Authority shall be held at least once in a month at a stipulated date and time.

(2) Every meeting of the Authority shall be presided over by the Chairperson.

(3) Notice of every meeting other than a special meeting shall be issued by the Convener to each member not less than one week before the date of the meeting.

17. Quorum and minutes. - One - third of the total number of members of the Authority shall form a quorum and all actions of the Authority shall be decided by a majority of the members present and voting.

18. Proceedings and minutes of meetings. - (1) The proceedings of the meetings of the District Registering Authority shall be preserved in the form of minutes which shall be authenticated after confirmation by the signature of the Chairperson.

(2) A copy the minutes of each meeting of the Authority shall be submitted to the Chairperson by the Member Secretary within 5-7 days of the meeting and after having been attested by him shall be sent to each member of the Council within 15 days of the meeting. If no objection to their correctness is received within 10 days of their dispatch, any decisions therein shall be given effect to, provided that the Chairperson may, where in his opinion it is necessary or expedient so to do, direct that action be taken on the decision taken in the meeting.

19. Resignation and filling of casual vacancies. - If a casual-vacancy occurs in the office of any other member, whether by reason of death, resignation or inability to discharge, functions owing to illness or any other incapacity, such vacancy shall be filled by the District Collector by making a fresh appointment and the member so appointed shall hold office for the remaining term of office of the person in whose place he/she is no appointed.

20. Registration of Clinical Establishments Application for Registration. - (1) The applicant shall apply to the District Registration Authority for provisional registration, either in person, or by post or through web based online facility with the necessary information in a format as per SG AR Annexe under sub sections (1) and (3) of section 14 of the Act.

(2) The applicant shall apply to the Authority for permanent registration, in person, or by post or through web based online facility with the necessary information filled and with evidence of having met the requirements of minimum standards and personnel for different categories of Clinical Establishments in a form and format that shall be prescribed by the National COuncil under sections 24 and 25 of the Act.

(3) If an establishment is offering services in more than one category as specified under these rules the establishment will need to apply for a separate provisional or permanent registration for each category of establishment under sub section (1) of section 14 and section 30 of the Act. However, if a laboratory or diagnostic center is a part of an establishment providing outpatient care, no separate registration will be required.

21. Acknowledgement of Application. - The Authority, or any person in his office authorized in this behalf, shall, acknowledge receipt of the application for registration, in the acknowledgement slip provided as per SGAA Annexe immediately, if delivered at the office of the authority, or not later than the next working day if received by post and by online acknowledgement to be generated automatically by the system.

22. Grant of Registration. - (1) The authority shall not undertake any enquiry prior to the grant of provisional registration and shall within a period often days from the date of receipt of such application, grant to the applicant a certificate of provisional registration containing particulars and information as per SGR Annexe either by post or electronically under section 15, read with section 17 of the Act.

(2) While granting/issuing registration certificate and License to any medical practitioner to run Clinic, Nursing Home or Hospital whether it is government or private or a clinical establishment, the conditions provided in the guidelines of Medical Council of India shall be made part and parcel of the registration Certificate/License.

23. Certificate of registration. - The Authority shall grant the applicant a certificate of permanent registration as per format developed by National Council either by post or electronically after satisfying itself that the applicant has complied with all the requirements and criteria, including provision of minimum standards and personnel required to run the clinical establishment.

In case of permanent registration, under section 29 of the Act, the authority shall pass an order within thirty days:-

(a) allowing the application for permanent registration; or

(b) disallowing the application:

Provided that the Authority shall record its justifications and reasons, if it disallows an application, for permanent registration.

24. Fees to be charged. - (1) The various fees charged for provisional and permanent registration, renewal, late application, duplicate certificate, change of ownership, management or name of establishment is prescribed in SGF Annexe under section 14 read with section 19, sub-section (1) of section 20, section 22; section 24 and sub-section (2) of section 35 of the Act. Clinical Establishments owned, controlled and managed by the Central/State Government or a local authority or a department of Government, shall be exempt from payment of fees for registration. The fees prescribed for various categories of clinical establishments may be revised by the State Council through a notification to be issued by the State Government. The fee shall be paid by a demand draft drawn/online transaction in favor of the Authority concerned as specified under sub section (1) 14 and section 30 of the Act. The fees collected by the Authorities for registration of the Clinical Establishments shall be, deposited by the Authority concerned in a Nationalized scheduled bank account opened in the name of the official designation of the Authority for the activities connected with the implementation of the provisions of the Act and these rules as approved by the Authority.

(2) There shall be constituted a fund called State Clinical Establishment Council Fund and all district authorities shall credit to such fund two percent of the total amount collected by them by way of fees and penalties. The Accounts shall be maintained as per the Financial Code and shall be audited by a qualified Chartered Accountant empanelled by CAG. The annual Audit reports shall be submitted to the concerned State Council. In the event of any change of ownership or management, the establishment shall intimate to the District Registration in writing within one month of such change along with the fee prescribed in SGF Annexe for issue of a revised certificate of Provisional or Permanent registration, as the case maybe, incorporating the changes and on surrendering the old certificate under sub section (2) of section 20 and section 30 of the Act.

(3) In the event of certificate of registration (Provisional or Permanent) being lost or destroyed, the owner shall apply to the Authority to issue a duplicate certificate upon payment of the fee prescribed in SGF Annexe under section 19 and section 30 of the Act.

25. Renewal of Registration. - (1) The clinical establishment shall apply for renewal of provisional registration thirty days before the expiry of the validity of the certificate of provisional registration. In case the application for renewal is not submitted within the stipulated period, the authority shall allow for renewal of registration on payment of the renewal amount as prescribed in SGF Annexe and penalty of Rs. 100 per day till the date of application for renewal under section 22 of the Act.

(2) For renewal of permanent registration, the clinical establishment shall apply three months before expiry of the registration period of Five years. The renewal will be granted by the Authority within three months of receipt of the application failing which it will be deemed to have been renewed. If the clinical establishment does not apply within one month of expiry of registration period, the registration will be deemed to have been suspended.

(3) Under sub-section (4) of section 30 of the Act the clinical establishment shall apply for renewal of permanent registration six months before the expiry of the validity of the certificate of permanent registration. In case the application for renewal is not submitted within the stipulated period, the authority will allow for renewal of registration on payment of the renewal amount as prescribed in SGF Annexe and penalty of Rs. 100 per day till the date of application for renewal is accepted.

26. Registers to be maintained, furnishing of returns and display of information. - Every Authority shall within a period of two years from its establishment, compile, publish and maintain in digital format Annexe SCO a register of Clinical Establishments registered by it and it shall enter the particulars of the certificate so issued in a register containing particulars as developed by National Council.

27. Registers to be maintained. - Every Authority including any other authority set up for the registration of clinical establishments under the law for the time being in force shall supply in digital format Annexe SGO to the State Council of Clinical Establishments a copy of every entry made in the District register of clinical establishments for a particular calendar month by the 15th day of the calendar month next following in keeping with provision of sub section (2) of section 37 of the Act.

28. Display of Information. - (1) The Authority shall, within a period of forty-five days from the date of grant of provisional registration, mandatorily cause to be published in the public domain either through two local newspapers or any- other public forums and on the website, which the Authority will launch, the name of the Clinical establishment, Address, Ownership, Name of Person in Charge, System of Medicine offered, Type and Nature of Services offered and details of the Medical Staff (doctors, Nurses, etc.) as provided under sub section (2) of section 16 of the Act.

(2) The State council may make changes in the nature of information to be provided in the Public Domain through a notification, except in the case of the mandatory information to be provided under sub-section (2) of section 16 of the Act.

(3) The Authority shall, within a period of seven days cause to be published in the public domain either through two local newspapers or any other public forums and on the website, which the Authority will launch, the name of the Clinical Establishment, Address, Ownership, Name of Person in Charge, System of Medicine offered, Type and Nature of Services offered, details of the Medical Staff (Doctors, Nurses, etc.) and the details and information related to having complied with the minimum standards and personnel prescribed for the particular category of Clinical Establishment under section 26 of the Act. The Authority shall cause to be displayed the above information in public domain for a period of 30 days for filing objections before granting permanent registration in (Annexe SGO).

(4) If any person has any objection to the information published regarding the clinical establishment they shall give in writing the reasons and evidence of objection or non-compliance to the Authority. the Authority shall, within a period of 15 days cause to be published in the public domain the name of the Clinical Establishment whose (Provisional or Permanent) registration has expired as under section 21 and section 30 of the Act.

29. Information to be provided by Clinical Establishments. - (1) The Clinical Establishments shall maintain medical records of patients treated by it and health information and statistics in respect of national programmers and furnish the same to the district authorities in form of three monthly reports. The minimum medical records to be maintained and nature of information to be provided by the Clinical Establishments will be as per the formats developed by the National Council.

(2) Copies of all records and statistics shall be kepi with the clinical establishment concerned for at least 3 years or in accordance with any other relevant Act for the time being in force under clause (iii) of sub section (1) of section 12 of the Act. All clinical establishments shall be responsible for submission of information and statistics in the time of emergency or disaster or epidemic situation.

(3) The State Government may notify from time to time, the nature of information that needs to be furnished by the Clinical Establishments including other disease notified for this purpose along with the prescribed interval. In addition to the specific provisions of the Act all establishments shall comply and maintain information and statistics in keeping with other applicable Acts and rules which are in force in the country.

30. Maintenance of Medical Records. - (1) Every physician shall maintain the medical records pertaining to his/her indoor patients for a period of 3 years from the date of commencement of the treatment in a standard proforma laid down by the Medical Council of India and appended to these rules as Appendix-E

(2) If any request is made for medical records either by the patients/authorised attendant or legal authorities involved, the same may be duly acknowledged and documents shall be issued within the period of 72 hours. In case, records are not supplied, it shall be punishable and make out a case for rejection of registration of such Hospital, Medical practitioner or Nursing Home by the competent authority.

(3) A registered medical practitioner shall maintain a Register of Medical Certificates giving full details of certificates issued. When issuing a medical certificate he/she shall always enter the identification marks of the patient and keep a copy of the certificate. He/she shall not omit to record the signature and/or thumb mark, address and at least one identification mark of the patient on the medical certificates or report. The medical certificate shall be prepared in Appendix-2.

(4) Effort shall be made to computerize medical records for quick retrieval."

(5) A supervising officer shall be designated who will ensure that conditions mentioned hereinabove are complied with by Medical Practitioners, Hospitals and Nursing Homes whether they are private or the Government. The Government Hospitals including SGPGI or other post graduate institutions shall also comply with the above conditions and provide a copy of entire medical records to the patients or their nominee within the aforesaid period of 72 hours after discharge from the respective hospitals.

(6) All Hospitals shall also maintain their record of each and every patient on the website starting from registration of the patient to the date of discharge.

31. Power to enter. - (1) Entry and search of a Clinical Establishment may be done by the Authority or an officer or team duly authorized by it or subject to such general or special orders as may be made by the authority. Such a decision will be required to be taken by majority of members.

(2) Such entry and search of clinical establishments may be conducted if running a Clinical Establishment without registration or does not adhere to the prescribed minimum standards or has reasonable cause to believe that the Clinical Establishment is being used for purposes other than that it is registered or contravenes any of the provisions of the Act or the rules or these rules shall at all reasonable times enter and inspect any record, register, document, equipment and articles as deemed necessary under the provisions of section 34 of the Act.

(3) The authority or the officers or the team referred to in sub rule (1) may at any time enter and examine all portions of the premises used or proposed to be used for the clinical establishment and inspect the equipments, furniture and other accessories and enquire into the professional qualifications of the technical staff employed or to be employed and shall make any such other enquires as may be considered necessary to verify the statements made in the application for registration and grant of license. All persons connected with the running of the establishment shall be bound to supply full and correct information to the authority or the officers or the team conducting the inspection.

(4) The officer/team shall submit a report as per SGIR Annexe within a week of the inspection to the Authority with a copy to the State Council. If at any time after any clinical establishment has been registered, the authority is satisfied that,-

(a) the conditions of the registration are not being complied with; or

(b) the person entrusted with the management of the clinical establishment has been convicted of an offence punishable under the Act, it may issue a notice to the clinical establishment to show cause within three months' time as to why its registration should not be cancelled for the reasons to be mentioned in the notice.

(5) If after giving a reasonable opportunity to the clinical establishment, the authority is satisfied that there has been a breach of any of the provisions of the Act or the rules made thereunder, it may, by an order, without prejudice to any other action that it may take against such clinical establishment, cancel its registration.

(6) Every order made under subsection (2) of section 41 of the Act shall take effect-

(a) where no appeal has been preferred against such order immediately on the expiry of the period prescribed for such appeal; and

(b) where such appeal has been preferred and it has been dismissed from the date of the order of such dismissal:

Provided that the authority, after cancellation of registration for reasons to be recorded in writing, may restrain immediately the clinical establishment from carrying its business on if there is imminent danger to the health and safety of patients.

32. Penalties. - In keeping with the provisions of sub sections (1),(2) and (3) and section 41 and sub-sections (1),(2) and (3) of section 42 of the Act, whoever carries on a clinical establishment without registration or whoever willfully disobeys any direction, or obstructs the authority or any officer or team authorized by it or withholds any such information or provides false information shall be liable to a monetary penalty.

Whoever carried on a clinical establishment without registration, shall, on first contravention be liable to a monetary penalty up to ten times of registration fee for second contribution to a monetary penalty which may extend to twenty times of registration fee and for third time contravention to penalty which may extend to fifty times of registration fee and for any further contravention the registration will be rejected/cancelled.

Whoever knowingly serves in a clinical establishment which is not duly registered under this Act, shall be liable to monetary penalty which may extend to twenty five thousand rupees.

The penalty fees collected by the authorities shall be, deposited by the Authority concerned in a Nationalized bank account opened in the name of the official designation of the State Council concerned and shall be utilized by the Council and authority for the activities connected with the implementation of the provisions of the Act as approved by the Council.

33. Appeals. - (1) In keeping with section 36, sub sections (4) (5) (6) and (7) of section 41 and sub-sections (4) (5) (6) and (7) of section 42 any person or clinical establishment, if aggrieved by the decision of the Authority under sections 29 and 34 of the Act, may file an appeal in the format SGA Annexe to the State Council within thirty days from the date of receipt of such order along with a fee of Rs.5000/-.

(2) The appeal against a public healthcare establishment shall be filed in form SGA and shall be sent to the State Council by registered post or in person.

(3) Every appeal shall be accompanied by a fee of rupees one thousand.

(4) After receipt of the appeal, the State Council shall fix the time and date for hearing and inform the same to the appellant and others concerned by a registered letter giving at least 15 days time for hearing of the case.

(5) The appellant may represent by himself or authorized person or a Legal practitioner and submit the relevant documentary material if any in support of the appeal.

(6) The State Council shall hear all the concerned, receive the relevant oral/documentary evidence submitted by them, consider the appeal and communicate its decision preferably within 90 days from the date of filing the appeal.

(7) If the State Council considers that an interim order is necessary in the matter, it may pass such order, pending final disposal of the appeal.

(8) The State Council will have the authority to stay the. operation of the order of the authority till such time as it deems necessary.

(9) The decision of State Council shall be final and binding.

(10) If no appeal is filed against the decision of the Authority in the prescribed period (i.e.) within 30 days from the date of receipt of the order, the orders of the Authority shall be final.

(11) The appeal fees collected by the an authority shall be deposited by the Authority concerned in a Nationalized bank account opened in the name of the official designation of the State Council and shall be utilized by the State Council and authority for the activities connected with the implementation of the provisions of the Act as approved by the State Council.

SG AR Annexe

{See rule 20 (1)}

Application Form for Provisional Registration of Clinical Establishments

1. Name of the Establishment:/Doctor (in case of single practitioner .................................................

2. Address: .................................................................................................. Village/Town: ................................................. Taluka : ................................................. District: ................................................. State : ................................................. Pin code : ................................................. Tel No (with STD code): ................................................. Mobile : ................................................. Website (if any): ..................................................................................................

3. Name of the owner: ..................................................................................................

Address: .................................................................................................. Village/Town: ................................................. Taluka : ................................................. District: ................................................. State: ................................................. Pin code: ................................................. Tel No (with STD code): ................................................. Mobile: ................................................. Email ID: ..................................................................................................

3(a) Name of Person in charge and Qualifications: ..................................................................................................

4. Ownership :-

(a) Public Sector: Central government State government Local government Public Sector Undertaking Any other (Please specify): .................................................

(b) Private Sector: Individual Proprietorship Registered Partnership Registered Company Co-operative Society Trust/Charitable Any other (please specify): .................................................

5. Systems of Medicine offered: (please tick whichever is applicable)

Allopathy Ayurveda Unani Siddha Homeopathy Yoga & Naturopathy.

6. Services Provided: (please tick whichever is applicable)

Inpatient Outpatient Laboratory/Imaging Centre Any other (please specify): .................................................

7. Category of Clinical Services: General Single Specialty Multi Specialty Super Specialty.

8. Type of Establishment: (please tick whichever inapplicable)

(a) Inpatient: Hospital Nursing Home Maternity Home Primary Health Centre Community Health Centre Sanatorium Day Care Center.

(b) Number of Beds: .................................................

(c) Outpatient: Single practitioner Polyclinic Sub-Centre Physiotherapy Clinic Occupational Therapy Infertility Clinic Dental clinic Dispensary Dialysis Centre Any other (please specify): .................................................

(d) Laboratory: Pathology Haematology Biochemistry Microbiology Genetics Collection Centre Any other (please specify): .................................................

(e) Imaging Centre: Please Specify: ..................................................................................................

Special diagnostics: Please Specify: ..................................................................................................

I hereby declare that the statements above are correct and true to the best my knowledge and shall abide by all the rules and declarations under the Clinical Establishment (Registration and Regulation) Am 2010. I undertake that I Shall intimate to the appropriate registering authority any change in the particulars given above.

Date:

Signature of the Authorized Signatory

SGAA Annexe

{See rule 21}

Acknowledgement of Application For Registration of Clinical Establishment

The application in Form.______________ for Grant / Renewal of Provisional / Permanent registration of the Clinical Establishment submitted by____________________________(Name and address of Owner) has been received by the District Registration Authority on____________________________ (date) and found to be Complete.

Incomplete

This acknowledgement does not confer any rights on the applicant for grant or renewal of registration.

Signature and Designation of Registration Authority or authorized person in the Office of the Appropriate Authority.

Seal

Designation of the Issuing Authority
Place & Date:

SG F Annexe

[See rules 24 and 25]

Fees to be Charged

Description	Urban		Rural		Metro
	Provisional	Permanent	Provisional	Permanent	Provisional	Permanent
Out Patient Care	100	500	50	250	200	1000
In Patient Care 1 to 30 beds 30 to 100 beds Above 100 beds
	100	500	50	250	200	1000
	200	1000	100	500	400	2000
	300	1500	150	550	600	3000
Testing & Diagnostic Laboratories Diagnostic & Imaging Centre
	2.00	1000	100	500	400	2000
	300	1500	150	650	600	3000

Other Fees:-

• For Renewal half the amount of registration fee (Provisional / Permanent)

• For Late Application the amount would be double of the registration fee(Provisional/Permanent)

• For Duplicate Certificate the amount would be Rs. 20G

• For change of ownership, management or name of establishment would be Rs 100

• For any appeal the amount would be Rs. 100

• If a laboratory or diagnostic center is a part of a establishment providing out patient / Inpatient care no separate registration is required.

SG R Annexe

{See rule 22 (1)}

Provisional Certificate
For Registration of Clinical Establishment

Provisional registration No:

Date of issue:

Valid up to:

1. Name of the Clinical Establishment: ...............................................

2. Address: ..................................................

3. Owner of the Clinical Establishment: ...............................................

4. Name of Person in Charge: ............................................................

5. System of Medicine : .....................................................................

6. Type of Establishment: ................................................................

Is hereby provisionally registered under the provisions of Clinical Establishments (Registration and Regulation) Act 2010 and the Rules made there under.

This authorization is subject to the conditions as specified in the rules in force under the Clinical Establishments (Registration and Regulation) Act 2010 and the Rules made there under.

Designation of the Issuing Authority
Place & Date:

District Registration Authority
Address:

Phone number in case of Grievances.

Annexe SGO

[See rules 26 and 27]

Display of registration status for filling objections

I, ..................... being the authority under the Clinical Establishment Act, 2010 after considering the applications received during the period; from .................to..................... under Section 24 satisfying the provisions of the clinical establishments Act, 2010 and the clinical establishments rules, 2011 made their under, hereby publish the list of Clinical Establishments: within the jurisdiction of..............district.

Serial No.	Name of Clinical Establishment with address	Ownership/In charge	System of medicine	Date on which Application was submitted	Category & Standards complied with

Objections if any, in writing to the published list may be addressed in duplicate to ...................................................................... (Address of the authority) within 30 days, from the date of this notification, as required under S. 26 of the Act.

Place:
Date:

Signature:
Name:

(Seal of the authority)

SG IR Annexe

{See rules 31 (4)}

Suggested Format for Submission of Inspection Report

Number of visits made with dates

Names and details of members of the inspection team

Name of clinical establishment visited

Address and contact details of clinical establishment visited

Process followed for inspection (e.g. kindly outline who was met with, what records were examined, etc)

Salient Observations/Findings

Conclusions

Specific Recommendations:

(1) To the Clinical Establishment

(2) To the District Registering Authority

*In case of lack of consensus amongst members of the inspection team, the same may be kindly Indicated

Signature (of all members of the inspection team)

Date

Place

SGA Annexe

{See rules 33 (1)}

Application for Appeal

To,

Sir,

I, Dr......................... of...................... Had applied for registration/ is a valid license holder with registration number........................ under clinical Establishment Act, 2010 for my...........................located at........................................................

I was communicated by the district authority as per letter no....................... dated that either;

(i) That my application was rejected

(ii) That my registration is cancelled

(iii) That I am restrained from carrying on with the running of clinical establishment

(iv) That I am charged with a penalty for an offence under the Act.

(v) Any other.......................................................................................

The above decision of the district authority appears to be not valid. I request you to consider my application as per the justifications mentioned below;

(i) ..............................................................

(ii) .............................................................

(iii) ............................................................

I am willing to appear before you for a personal hearing, if necessary. I am enclosing herewith a draft of Rs. 1000/-

Thanking you,

Place:
Date:

Signature:
Name:

Appendix-1

Format For Medical Record

{See rule 30(1)}

Name of the patient:

Age:

Sex:

Address:

Occupation:

Date of First Visit:

Clinical note (Summary) of the case:

Prov: Diagnosis:

Investigation advised with reports:

Diagnosis after investigation:

Advice:

Follow up:

Date:

Observation:

Signature in full .................

Name of Treating physician.

Annexe-2

[See rule 30 (3)]

From the Certificate Recommended For Leave or Extension or Communication of Leave and For Fitness

Signature of patient

or thumb impression................................

To be filled in by the applicant in the presence of the Government Medical Attendant, or Medical Practitioner.

Identification marks:-

a............................

b........................................

I, Dr........................ after careful examination of the case certify hereby that ...................... whose signature is given above is suffering from ................. .................... and I consider that a period of absence from duty of ................ with effect from ....................... is absolutely necessary for the restoration of his health.

I, Dr. .................... after careful examination of the case certify hereby that ............. on restoration of health now fit to join service.

Signature of Medical attendant
Registration No....................

(Medical Council of India/State Medical Council of ................State)