Rules

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EXTRAORDINARY

PUBLISHED BY AUTHORITY

No. 660, CUTTACK, W EDNESDA Y, APRIL 25, 20 18/BAISAKHA 5, 1940

HEALTH & FAMILY WELFARE DEPARTMENT

NOTIFICATION

The 23rd April, 2018

No.12270–HFW-DCMA-MISC-0163/2017/H.— Whereas, the draft of the Odisha Clinical Establishments (Control and Regulation) Rules, 2017 was published as required under section 20 of the Odisha Clinical Establishments (Control and Regulation) Act, 1991 (Odisha Act 8 of 1992) in the Extraordinary Issue No. 1118 of the Odisha Gazette dated the 24th June 2017 under the notification of the Government of Odisha in the Health and Family Welfare Department No. 16441-DC & MA-MISC-07/2013 (pt.)/H. dated the 22nd June 2017 inviting objections and suggestions from all concerned likely to be affected thereby till the expiry of a period of ninety days from the date of publication of the said notification in the Odisha Gazette;

And, whereas, the objections or suggestions received in respect of the said draft have been duly considered by the State Government;

Now, therefore, in exercise of the powers conferred by Section 20 of the said Act and in supersession of the Odisha Clinical Establishments (Control and Regulation )Rules 1994 except as things done or omitted to be done before such supersession, the State Government do hereby make the following rules, namely:-

1. Short title and commencement. — (1) These rules may be called the Odisha Clinical Establishments (Control and Regulation) Rules, 2018.

(2) They shall come into force on the date of their publication in the Odisha Gazette.

2. Definitions. — (1) In these rules, unless the context otherwise requires,—

(a) "Act" means the Odisha Clinical Establishments (Control and Regulation) Act, 1991 (Odisha Act 8 of 1992);

(b) "Form" means a form appended to these rules;

(c) "Government" means the Government of Odisha;

(d) "Schedule" means a Schedule appended to these rules;

(e) "Section" means a Section of the Act;

(2) Words and expressions used herein but not defined shall have the same meaning respectively assigned to them in the Act.

3. Application for Registration. — (1) Any person who intends to establish and maintain a clinical establishment, shall apply to the supervising authority in Form 'A' by post or in person or electronically or as may be specified by the Government from time to time.

(2) The minimum requirements and standard of services shall be complied as specified in the Schedules I and II for different types of clinical establishments within six months from the date of these rules coming into force.

(3) The application referred to in sub-rule (1) shall be accompanied by the documents specified in the Schedule III along with the proof of payment of fees as specified in the Schedule IV which shall be deposited in the Government Treasury under the head of account "0210-MEDICAL AND PUBLIC HEALTH-01-URBAN HEALTH SERVICES-02-RECEIPTS FROM PATIENTS FOR HOSPITAL AND DISPENSARY SERVICES-0010-CHARGES FOR SERVICE PROVIDED -02087 OTHER FEES".

(4) The fees for grant of a Certificate of Registration or renewal thereof shall be non- refundable in nature.

(5) The Supervising Authority, on receipt of an application for grant of certificate of registration or renewal thereof, shall transmit the same to the Inspecting Authority within the period of seven working days from the date of receipt of the application for scrutiny to ascertain if the application is inconformity with the provisions of the Act and the rules and also conduct physical inspection of the premises where the clinical establishment is proposed to be established.

(6) The Inspecting Authority shall ascertain the availability of the minimum standard of requirements and whether other parameters as specified in different Schedules have been complied and shall send the report of inspection in Form 'B' to the Supervising Authority who shall consider the same keeping in view the conditions stipulated in Section 5 and after being satisfied that there is no objection to grant certificate of registration, he shall issue such certificate in Form 'C' within a period of forty five days from the date of receipt of such application.

(7) In case of refusal of grant of Certificate of Registration or renewal, the Supervising Authority, shall inform the applicant in writing indicating clearly the deficiencies or causes of rejections, with a direction to comply the deficiencies within a period of one month for consideration.

4. Renewal of Registration.— (1) The Certificate holder may apply for renewal of Certificate of Registration in Form 'A' to the Supervising Authority, not less than six months before the date on which the period of validity of the Certificate of Registration is due to expire and accompanied with fee prescribed in Schedule IV.

(2) On receipt of an application under sub-rule (1), the Supervising Authority shall, if satisfied that the certificate holder does not contravene any of the provisions as mentioned in sub- section (5) of Section 6, renew the Certificate of Registration in Form 'C' before the expiry of the period of Certificate of Registration.

(3) If the application for renewal of Certificate of Registration has been filed within the time referred to in sub-rule (1) and is not disposed of by the Supervising Authority before the date of expiry of the period of such Certificate, the validity of that Certificate shall be deemed to have been extended for a further period of three months or till the Supervising Authority passes order thereon, whichever is earlier.

5. Loss or damage of Certificate of Registration.— (1) In case, the Certificate of Registration is lost, defaced or stolen, the Certificate holder shall apply to the Supervising Authority along with a fee of five hundred rupees in shape of Treasury Challan deposited in the Government Treasury under the head of account specified in sub-rule (3) of rule 3 with a self3 declaration to the effect that the Certificate of Registration is actually defaced, lost, damaged or stolen and in case such Certificate is stolen or lost, a copy of FIR lodged in the police station shall be enclosed therewith.

(2) After receipt of such application made under sub-rule (1), the Supervising Authority after being satisfied with the fact, may issue a Certificate of Registration marked as 'duplicate'.

6. Inspection of Clinical Establishment.— The Supervising Authority or the Inspecting Authority shall inspect the clinical establishments by entering into the premises as and when required in presence of the In-charge of a clinical establishment or in his absence, any other person looking after the affairs and management of the clinical establishment so as to satisfy himself that the provisions of the Act and the rules have been duly complied with and shall submit a report to that effect to the Supervising Authority, if the authority inspecting is not the Supervising Authority.

7. Maintenance of registers and records by Clinical Establishment. — (1) Every clinical establishment registered under the Act shall maintain all such registers and records in Form 'D' and shall produce the same before the Supervising Authority or any officer empowered by it as and when required by such authority.

(2) Where a clinical establishment is required to give free treatment to the persons belonging to Below Poverty Line under the Act and the rules, such clinical establishment shall maintain a separate register in Form 'E'.

Explanation. — For the purpose of facilitating free treatment the card holder of RSBY, BKKY, NAFS shall be treated as Below Poverty Line.

(3) A copy of discharge summary of medical treatment containing all relevant information like Patient name, age, sex, address, time and date of admission, diagnosis, treatment given, investigations done, cause of referral and further advice if any given, shall be supplied to the patient treated in the said clinical establishment, if demanded, at free of cost while referring such for further treatment in the Government Hospital or to any other clinical establishment.

8. Display of certificates.— (1) The certificate holder of the clinical establishment shall display the Certificates of Registration and renewal thereof including fire safety certificate and the no objection certificate issued by the Odisha State Pollution Control Board, and any other statutory certificate at a conspicuous place for public information.

(2) In addition to requirement of displaying the certificates, as required under sub-rule (1), the certificate holder of the clinical establishment shall be liable to display the Government order or the order issued by any other authority duly authorized by the Government so as to show how many patients are BPL card holder in both OPD and IPD and they have been treated till a particular date.

9. Manner of Inquiry by the Supervising Authority.— The Supervising Authority shall hold the inquiry as required under section 14-A in the following manner, namely:—

(a) a show cause notice shall be issued within fifteen days of inspection to the owner, proprietor or the management thereof or the concerned clinical establishment indicating the deficiencies or contraventions of the provisions of the Act or the rules for which imposition of fine is proposed;

(b) after receipt of the show cause notice, the owner, proprietor or management thereof, the clinical establishment shall comply with the deficiencies or contraventions of the provision of the Act and the rules within seven days or such further period as may be allowed by the Supervising Authority from the date of receipt of notice;

(c) on receipt of compliance from the owner, proprietor, management thereof, from the concerned clinical establishment, the Supervising Authority shall, after examining4 the same and giving an opportunity to such owner, proprietor, management thereof for hearing in person, impose fine having regard to sub-section (3) of Section 14-A.

10. Undertaking for treatment to patients in emergency conditions.— (1) Every certificate holder of the clinical establishment shall give an undertaking in Form 'F' at the time of applying for registration or renewal to the effect that it shall provide medical treatment to patients in emergency conditions and stabilize the condition of patient within the staff and facility available, before sending him to any another clinical establishment or the Government hospital.

(2) The clinical establishment shall also obtain an undertaking from the patient or his attendant in Form 'G' to the effect that he wants to be treated in the said clinical establishment.

11. Appeal. — (1) Any person aggrieved by any order passed by the Supervising Authority under sub-section (1) of section 9 or sub-section (5) of section 14-A, as the case may be, prefer an appeal in Form 'H' accompanied with fees of five hundred rupees in shape of Treasury Challan to the prescribed authority constituted under sub-rule (2) within a period of sixty days from the date of passing of the order and every such appeal preferred under this sub-rule shall contain all material statement and argument relied upon by the person preferring appeal.

(2) The prescribed authority shall consist of the following members, namely:—

(a) Secretary to Government, Health and Family

Welfare Department or in his absence the Special

Secretary … Chairman

(b) Director of Medical Education and Training,

Odisha … Member

(c) Director of Health Services, Odisha … Member

(3) The prescribed authority shall dispose of the appeal within one month from the date of its filling by the appellant giving him an opportunity of personal hearing before disposing the appeal.

(4) The prescribed authority may require the service of such other subject experts as it may deem fit.

12. Report in case of death of the certificate holder.— In case the holder of a Certificate of Registration is unable to function for any reason or where the certificate holder dies, the certificate holder or, as the case may be, the legal representative of such certificate holder, shall forthwith report the matter to the Supervising Authority in Form 'I'.

Schedule –I

[See Rule 3(2)]

Minimum Requirements

General requirement:

1. Location: The premises shall preferably be situated in a sanitary place free from pollution.

2. Building: The building used for clinical establishment must be spacious for maintenance of hygienic condition. The buildings which are newly constructed after the Odisha Clinical Establishment (Control and Regulation) Rules, 2017 notification, must be as per guidelines of National Building Code 2005. Provision of fire safety measures must be made available to fight fire hazards. A fire safety certificate or self declaration as per the Rules / guidelines issued by Home Deptt., Odisha / Director General, Fire Service, Home Guards and Civil Defense, Odisha for the time being in force shall be enclosed along with application.

3. Waiting area and CCTV: The clinical establishment having more than 100 beds shall be covered by CCTV camera for adequate surveillance.

4. The premises of the clinical establishment shall be accessible to physically challenged patients.

5. Water and electricity supply and waste disposal: All the clinical establishments having admission and operation facility must preferably have safe drinking water supply and electricity. The waste matter must be disposed properly.

7. Staff: All the paramedical staff (pharmacist, nurses, technicians, attendants and sweepers) must be in clean dresses. The staff on duty should not have contagious disease. In such case they should be refrained from patient care till they are cured.

Specific requirements

2. IMMAGING UNITS (X Ray, CT Scan, Interventional Radiology, C-Arm/O-Arm

and equipment with Fluoroscopy mode or any other instrument as may be notified

by AERB from time to time (Must follow AERB guidelines and obtain license /

registration from AERB)

6. HOSPITALS OR NURSING HOMES OR ANY CLINICAL ESTABLISHMENT

Schedule –II

[See Rule 3(2)]

Minimum Standard of services

The main aim of the standard of service is patient comfort and compassion treatment by qualified medical and paramedical personals.

Following standards of services must be available and ensured to the patient as well as their attendant.

Preferably:

1. Reception counters to receive as well as counseling of patient for giving guidance for appropriate treatment.

2. A comfortable waiting place/room for patient and attendant.

3. The ward must be well lighted and ventilated.

4. The hospital must be infection free. Regular cleaning and disinfection of Operation Theatres must be undertaken.

5. All the Medical and Paramedical staff must wear clean dress.

6. There must be sufficient number of toilet/s which must be clean with water supply. 7. Hospital must have independent power backup.

Mandatory:

8. Consultation with a qualified registered Medical/ Dental /AYUSH practitioner. If a Government doctor is consulted then date and time of such consultation must be maintained in a register with address and mobile number. The clinical establishment must ensure that no treatment is being provided by unauthorized persons or a Government doctor during his/her duty hours.

9. Prescription, diagnosis and investigation must be made at par with the standard treatment protocol.

10. Operation Theatre (minimum size 12ft x 15ft) with good quality instruments / equipments for emergency care and life saving measures.

11. Post operatively the patient must be visited by the surgeon at least once daily and such work must not be left to paramedical staff.

12. Any patient with emergency conditions must be attended immediately and if facility is not available for management, first aid shall be given to stabilize the patient and then transferred to appropriate hospital.

13. In hospitals or nursing homes with admission facility, there must be a doctor in overall in-charge and available 24 hrs.

14. The staff nurses must be qualified and registered under ONMC. The nurse to bed ratio must be 3:15 + 10% as Leave Reserve.

15. The Bio Medical Wastes must be properly disposed of.

16. No exorbitant fees shall be collected especially from poor patient holding BPL Card or any other card of like nature issued by the Government enabling them for free treatment or treatment at reduced rate.

17. No patient or its attendant or dead body of patient shall be detained for not paying the fees of hospital. The CE must develop mechanism for day to day collection of bill claimed.

18. No unethical practice shall be made by Clinical Establishment to induce or entice patients. The Government doctors (during duty hours), Superspeciality students, PG students, Senior Residents are not authorized for private practice.

Schedule III

[See Rule 3(3)]

Check List of Documents

(All documents are to be signed by applicant)

Schedule –IV

[See rule 3(3)]

Details of Registration Fees

Table- A

Table- B

N.B: The applicant is entitled to pay fees as per both Table A and Table B as applicable.

FORM-A

[See Rule 3(1) and Rule 4 (1) ]

APPLICATION FORM FOR REGISTRATION OR RENEWAL OF CLINICAL

ESTABLISHMENT

Under Odisha Clinical Establishments (Control and Regulation) Act.1990

(The application form may be typed on a separate paper to accommodate the required fields.)

1. NAME OF THE CLINICAL

Photo of the applicant ESTABLISHMENT:______________________________________

(Attach a photo of the Clinical Establishment)

2. ADDRESS OF THE CLINICAL ESTABLISHMENT(with e-mail and phone

No.):___________________________________

(in case of shifting of a clinical establishment mention both the existing & proposed new address)

3. NAME AND ADDRESS OF THE APPLICANT AND IN THE CAPACITY

OF:_____________________________________

(owner/proprietor/Managing partner/Director/ other) if the applicant is not the proprietor then name and address of contact person)

4. CONTACT DETAILS OF THE CE (EMAIL & PHONE

NO):__________________________

5. NAME, ADDRESS AND REGISTRATION NUMBER, IF ANY OF THE CE IN-

CHARGE: (Attach a photo)

___________________________________________________________________

6. NATURE/SCOPE OF SERVICES APPLIED FOR BY THE CLINICAL

8. Para Medical Personnel Engaged

9. Other staffs if any:

Declaration

I Sri/Smt/Dr ……………………………………………………… in the capacity of ……………………………………………………….……………… of the clinical establishment named ……… ……………………………………………………………………………… ...

situated at ……………………………………………………………………… do hereby undertake that the facts above stated in my application for registration / renewal under rule 4 are true to the best of my knowledge and belief. In case any of the information submitted by me is found to be false, incorrect and deliberately misleading or materially suppressed, my registration is liable for cancellation and legal action as deemed proper may be initiated against me.

Enclosures: Documents as per the check list in Schedule – D.

Signature of applicant Date........................

FORM–B

[ (See Rule-3(6) ]

INSPECTION REPORT FOR REGISTRATION/RENEWAL OF CLINICAL

ESTABLISHMENT

Date:- Signature of Inspecting Authority Place:-

FORM-C

[See Rule-3(6) and Rule-4]

GOVERNMENT OF ODISHA,

HEALTH & FW DEPARTMENT

CERTIFICATE OF REGISTRATION/RENEWAL

Under Odisha Clinical Establishments (Control & Regulation) Act.1990

This is to certify that Sri/Smt/Ms./Dr./M/s________________________________

an applicant for ___________________________________________________________ in the capacity of ___________________________________________________________

at_____________________________________________________________________ has fulfilled the Criteria to run a Clinical Establishment with following services only.

The establishment is registered/ renewed under the provisions of the Act with following particulars and terms & conditions.

REGISTRATION NUMBER ___________________ Date of issue: ________________

PERIOD OF VALIDITY From: ___________________To ____________________

IN-CHARGE (If a doctor then the_____________ Regn..No_____)

(With Qualification)

Signature of

Supervising Authority

Terms & Conditions:

1. That the CE shall abide by the provisions of the Odisha Clinical Establishments (Control and Regulation) Act 1990, rules made there under.

2. That for renewal, application shall be made to the authority not less than six months before its expiry.

3. Any change in the constitution or management of the clinical establishment shall be intimated not later than fifteen days to the supervising authority along with the original certificate for issue of new one.

4. Any change of staff of the Clinical establishment must be reported to the Supervising Authority within one month of such change.

5. All certificates of the establishment including OSPCB, Fire Safety, Trade license, Approved Rate chart, Name of Staff on duty etc., must be displayed in a prominent place for viewing of public.

FORM-D

[See Rule 7(1)]

FORM -E

[See Rule 7(2)]

Part I-Report of treatments of BPL patients

FORM– F

[See Rule 10(1)]

Undertaking for managing emergency conditions

I Sri/Smt/Dr ……………………………………………………… in the capacity of Proprietor / In-charge/Managing Director/owner of the Clinical Establishment named ………

……………………………………………………………………………… ... situated at ……………………………………………………………………… do here by undertake to provide such medical treatment in emergency medical conditions and stabilize the emergency medical condition as may be necessary for the patient during the period of stay in the clinical establishment within the staff and facilities available in my clinical establishment.

Full Signature of the

Certificate holder of

the clinical establishment18

FORM-G

[See Rule 10(2)]

(Undertaking by the Patient/Attendant for treatment at the time of emergency medical

condition)

I Sri/Smt. ……………………………………… son of /daughter of / wife of .. … … At./Po./ PS/District… … (Specify address)…. ….. . ….. ….. ….. …… … .. .. do here by undertake that knowing the detail of staff and facility available I am willing for the treatment of self /the patient, Sri/Smt.… … … … … … …. … …. … … in emergency medical condition at …. … … … … …

… … … … … … (Specify the name and address of the clinical establishment). The authorities of the above clinical establishment shall not be responsible for the outcome.

Full Signature of the Patient/Attendant

Place-

Date-

FORM -H

[(See Rule -11(1)]

To The Principal Secretary to Government, Health & Family Welfare Department, Odisha Secretariat, Bhubaneswar, 751001.

Sub: Appeal against the action of Supervising Authority

Sir/Madam, I Sri/Smt. ………………………………….……………………………. owner/ proprietor/ Managing partner/ Director as the case may be of the Clinical Establishment (name to be given) ……… …………………………………………………………………………………… being aggrieved by the action of the Supervising Authority, do hereby make an appeal for reconsideration of my application at an earliest. The fees of Rs.500/- (Rupees five hundred only) in shape of Treasury Challan and related documents are enclosed for reference.

Grounds of Appeal in brief: (Separate sheets of paper may be used) 1. 2.

Yours faithfully, (Name of the applicant, Address)19 …………………………………Acknowledgement …………………………

Received an appeal from Sri /Smt ……………………………………………… In-charge of Clinical Establishment…………………………… …………… under section 9 of the Odisha Clinical Establishment (Control and Regulation) Act, 1990 and read with rules14 &15 of the Odisha Clinical Establishment (Control and Regulation) Rules, 2018.

Signature, Date & Seal of receiving officer

FORM-I

(See Rule -12)

To

Supervising Authority,

Clinical Establishments,

District:……………….

Sir,

I/We do hereby bring to your kind notice that the holder of Certificate or Registration Sri…

… … … …. … of the clinical establishment … … unable to function for such reasons.. … .

…./died on… … due to … … .. (cause of death).

Registration Number of the Clinical Establishment:

Hence the above Clinical Establishment may be registered in my name.

Yours faithfully,

(Signature of the owner/proprietor of Clinical Establishment) 1. Enclose copy of the death certificate.

2. Original Registration certificate

3. Affidavit to the effect that he/she will run the clinical establishment as per the provisions of OCE(CR) Act and Rules there under and the status of the Clinical Establishment is as it is.

Signature of certificate holder/legal representative

By Orders of the Governor

Dr. P. K. MEHERDA Commissioner-cum-Secretary to Government

Printed and published by the Director, Printing, Stationery and Publication, Odisha, Cuttack-10 Ex. Gaz. 137-173+100