EXTRAORDINARY

PUBLISHED BY AUTHORITY

No. 660, CUTTACK, WEDNESDAY, APRIL 25, 2018/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;

(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 self

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;

concerned clinical establishment, the Supervising Authority shall, after examining

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:

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

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.

Waiting area and CCTV: The clinical establishment having more than 100 beds shall be

covered by CCTV camera for adequate surveillance.

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

patients.

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.

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

1. PATHOLOGY/ MICROBIOLOGY /BIOCHEMICAL INVESTIGATION UNITS

Sl.

No.

Particulars

Quantity/

Number

Manpower

Consultant

MBBS (for all areas except Municipal

Corporation for basic hematology, stool,

urine) or

MD Pathology/Biochemistry/Microbiology)

(MBBS doctors can sign the reports. But in case of

difficult tests like Biopsy, Cytology, Culture Sensitivity,

Imaging etc. the opinion of Pathologist or Biochemist

or Microbiologist or Radiologist as the case may be

shall be obtained before signing reports.)

Technician (Preferably qualified LT from

institutions recognized by any State

Government/AICTE)

Government doctor/staff cannot be a

proprietor/ in-charge (The in-charge doctor

and consultant may be one person)

Infrastructure

(preferably)

Waiting Room

Testing Room

Toilet

Equipments/

Reagents

All glassware, chemicals and reagents

required for the tests, microscope,

colorimeter/ spectrophotometer etc as per the

tests conducted.

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)

3. ULTRASONOGRAPHY UNIT

Sl.

No.

Particulars

Quantity/

Number

Manpower

In-charge doctor /consultant

MD in Radiology/O&G, MBBS with six

months training in USG or have passed

Competency Based Evaluation as per

PCPNDT Rule 2014

Staff Nurse/ANM / Female attendant

Proprietor (Any person including the above

in-charge doctor).

Govt. doctor/staff cannot be a proprietor

Infrastructure

(Preferably)

Waiting Room

USG Room

Toilet

Equipment

USG machine

4. DENTAL CLINICS

Sl No

Particulars

Quantity/

Number

Manpower

-In-charge doctor /consultant

(BDS/MDS in any discipline of Dentistry )

-Dental attendant

Government staff cannot be a proprietor or in-

charge.

Infrastructure

Waiting Room

Clinic Room

Equipment

Equipment and instruments required for the

type of service to be provided.

X-Ray machine

If available must be approved by AERB

5. PHYSIOTHERAPY UNITS

Sl No

Particulars

Quantity/Nu

mber

Manpower

In-charge / Consultant

Physiotherapist (BPT )

Attendant (one male and one female)

Government staff cannot be a proprietor or in-

charge.

Infrastructure

(Preferably)

Common Room for reception, waiting,

consultation etc.

Treatment Room

Toilet

Equipments

Equipments and instruments required for the

type of service to be provided.

6. HOSPITALS OR NURSING HOMES OR ANY CLINICAL ESTABLISHMENT

WITH BEDS

Sl No

Particulars

Quantity/Nu

mber

Manpower

In-charge doctor (MBBS/other recognized

system doctor, as per the service provided)

Consultant s (MD/MS) in the concerned system

of medicine as per treatment provided.

Govt. staff cannot be a proprietor or in-charge.

Staff Nurse (preferably with GNM/B.Sc.

Nursing) 3 nurse per 15 beds + 10% of total SN

required as leave reserve. ANM can work

under supervision of Staff Nurse

One Pharmacist if the unit has its own medicine

store.

Pathologist / biochemist / microbiologist

(if having a pathology/ biochemical/

microbiological laboratory)

Technician ( if having a pathology/

biochemical/ microbiological laboratory )

Preferably qualified LT from institutions

recognized by any State Government/AICTE

For OT having one OT table (one pharmacist,

one staff nurses, one attendant )

Sweeper 1:20 beds ratio per shift

For ICU (one staff nurse / 2 beds, one

attendant, one doctor trained in ICU/anesthesia)

Infrastructure

Common Room for reception, waiting,

consultation etc.

Treatment Room/ Ward/ Operation Theatres if

surgery done, Toilets etc.

Equipment

Equipment and instruments required for the

type of service provided.

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)

Sl No.

Document

Registration/Renewal Fees in shape of treasury Challan.

Ink signed original Consent Letters of the medical and paramedical persons to

work in the establishment along with a self attested color passport size photo.

Copy of self attested Degree or Diploma certificate of the medical/paramedical

persons

Copy of self attested up-to-date registration certificates from concerned councils of

paramedical staff (preferably) and mandatory for Doctors.

Copy of self attested up-to-date Registration Certificate of clinical establishment

for renewal.

Proof of ownership / agreement deed with landlord for five years.

Occupancy certificate, in case of clinical establishments having 30 beds or more

and functioning in buildings constructed after notification of this Rule.

Location Map

Fire Safety Certificate or self declaration (as per Rules/guidelines /clarifications

notified by Home Department / Director General, Fire Service, Home Guards and

Civil Defense, Odisha or any appropriate authority from time to time)

Authorization from State Pollution Control Board (if Applicable)

Trade License (If Applicable)

PCPNDT Certificate for USG (If Applicable)

License / Registration from AERB for X-Ray/ CT Units etc.

Authorization for MTP from appropriate authority if applicable.

Instrument/Equipment List

Rate Chart for different Procedures

(to be approved by Supervising Authority with reference to CGHS rate chart)

Undertaking to the effect that any of the employees/consultants including the

owner/proprietor/Managing partner/Director as the case may be were not

convicted in past for any offence or no criminal case is lying pending before any

court of law pertaining to the Clinical Establishment.

Undertaking for maintenance of record, for providing free treatment to BPL

patients, for treatment of patients in emergency .

Schedule –IV

[See rule 3(3)]

Details of Registration Fees

Table- A

Sl. No.

Facilities available in the Clinical

Establishment