Puducherry Clinical Establishments (Registration and Regulation) Rules, 2014.

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La Gazette de L' État de Poudouchéry

The Gazette of Puducherry

PART - II

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®ı Amflºƒˆ A>[˛wÁ\ 2014 } \VÏfl | 5 { No. 8 Poudouchéry Mercredi 5 Mars 2014

No. Puducherry Wednesday 5th March 2014

( 14 Phalguna 1935)

GOVERNMENT OF PUDUCHERRY

HEALTH SECRETARIAT

(G.O. Ms. No. 15, dated 26th February 2014)

NOTIFICATION

In exercise of the powers conferred by sub-section (1) of section 54

of the Clinical Establishments (Registration and Regulation) Act, 2010

(Act No. 23 of 2010), the Lieutenant-Governor, Puducherry hereby makes

the following rules, namely :—

[ 45 ] 46 LA GAZETTE DE L'ETAT [PART–II

1. Short title, application and commencement.— (1) These rules may be called the Puducherry Clinical Establishments (Registration and Regulation) Rules, 2014.

(2) These rules shall be applicable to all the clinical

establishments in the Union territory of Puducherry:

Provided that it shall be applicable to various categories of clinical establishments in a phased manner, as may be notified from time to time.

(3) These rules shall come into force on the date of their

publication in the official gazette of Puducherry.

2. Definitions.— In these rules, unless the context otherwise

requires,—

(a) 'Act' means the Clinical Establishments (Registration and

Regulation) Act, 2010.

(b) 'Rules' means the rules made under the Act.

(c) 'Authority' means the District Registering Authority

established under section 10 of the Act.

(d) 'Certificate' means certificate of permanent registration

issued under section 30 of the Act.

(e) 'Clinical Establishment' means.—

(i) a hospital, maternity home, nursing home, dispensary, clinic, sanatorium or an institution by whatever name called that offers services, facilities requiring diagnosis, treatment or care for illness, injury, deformity, abnormality or pregnancy in any recognised system of medicine established and administered or maintained by any person or body of persons, whether incorporated or not; or

(ii) a place established as an independent entity or part of an establishment referred to in sub-clause (i), in connection with the diagnosis or treatment of diseases where pathological, bacteriological, genetic, radiological, chemical, biological investigations or other diagnosis or investigative services with the aid of laboratory or other medical equipment, are usually carried on, established and administered or maintained by any person or body of persons, whether incorporated or not, and shall include a clinical establishment owned, controlled or managed by—

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PART–II] LA GAZETTE DE L'ETAT

(i) the Government or a department of the Government;

(ii) a trust, whether public or private;

(iii) a Corporation (including a society) registered under a Central, Provincial or State Act, whether or not owned by the Government:

(iv) a local authority, and

(v) a single doctor, but does not include the clinical establishments owned, controlled or managed by the Armed Forces constituted under the Army Act, 1950, the Air Force Act, 1950 and the Navy Act, 1957.

(f) 'Emergency Medical Condition' means a medical condition including any illness and/or intentional or accidental injury of any nature that may manifest itself by acute symptoms of sufficient severity (including severe pain) of such a nature that the absence of immediate medical attention could reasonably be expected to result in-

(i) placing the life or health of the individual or with respect to a pregnant woman, the life or health of the woman or her unborn child, in serious jeopardy.

(ii) serious impairment to bodily functions; or

(iii) serious defunction of any organ or part of a body.

(g) 'Form' means a Form appended in these rules.

(h) 'National Council' means the National Council for Clinical

Establishments established under section 3(1) of the Act.

(i) 'Notification' means a notification published in the official

gazette.

(j) 'State Council' means the Puducherry Council for Clinical

Establishments established under the section 8 of the Act.

(k) 'Prescribed' means prescribed by rules made under the Act by the Central Government or Government of Puducherry, as the case may be.

(1) 'Recognised System of Medicine' means Allopathy, Yoga, Naturopathy, Ayurveda, Homeopathy, Siddha and Unani system of medicines or any other system of medicine as may be recognised by the Central Government from time to time.

48 LA GAZETTE DE L'ETAT [PART–II

(m) 'Register' means the register maintained by the authority, Government of Puducherry and the Central Government under sections 37, 38 and 39 respectively of the Act containing the number of clinical establishments registered.

(n) 'Registration' means to register under section 11 and the expression registration or registered shall be construed accordingly;

(o) 'Standards' means the conditions that the Central Government prescribed under section 12, for the registration of clinical establishments from time to time;

(p) 'State Government' means, the Administrator thereof appointed

by the President under Article 239 of the Constitution; and

(q) 'To stabilize' means, with respect to an emergency medical condition specified in clause (f), to provide such medical treatment of the condition as may be necessary to assure, within reasonable medial probability, that no material deterioration of the condition is likely to result from or occur during the transfer of the individual from a clinical establishment.

The words and expressions used herein and not defined but defined in the Act shall have the same meanings respectively assigned to them in the Act.

3. The Puducherry Council for Clinical Establishments.— (1) The Government of Puducherry shall by notification constitute a Union Territory Council called "Puducherry Council for Clinical Establishments" under section 8 of the Act.

(2) Functions of the Puducherry Council for Clinical

Establishments:-

The Puducherry Council for Clinical Establishments shall perform

the following functions, namely:-

(a) compiling and updating the Union Territory Registers of

clinical establishments;

(b) sending monthly returns for updating the National Register ;

(c) representing the Union Territory in the National Council;

(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 the Union Territory;

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PART–II] LA GAZETTE DE L'ETAT

(f) monitor the implementation of the provisions of the Act and

rules in the Union Territory;

(g) recommend to the Government, any modifications required in the rules in accordance with changes in technology or social conditions;

(h) perform any other function as may be outlined by the

National Council for Clinical Establishments;

(i) any other function as may be prescribed by the

Central Government/State Government.

(3) Disqualification for appointment as member of the State

Council:

A person shall be disqualified for being appointed as a member of

the Puducherry Council for Clinical Establishments, if he -

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

(b) is an undischarged insolvent; or

(c) is of unsound mind and stands so declared by a competent

court; or

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

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

(4) Conduct of business: Every meeting of the Union Territory

Council shall be presided over by the Chairperson.

(5) Meeting of the State Council:The meeting of the State Council shall ordinarily be held at Puducherry on such dates as may be fixed by the Council and the State Council shall meet at least once in three months.

(6) Notice of meeting : Notice of every meeting other than a special meeting shall be issued by the Member-Secretary to each member of the Council not less than one week before the date of the meeting.

50 LA GAZETTE DE L'ETAT [PART–II

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

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

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

(10) A copy of the minutes of each meeting of the State Council shall be submitted to the Chairperson within 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 decision therein shall be given effect to, provided that the Chairperson may, where in his opinion it is necessary or expendient so to do, direct that action be taken on the decision of the meeting.

(11) Resignation and filling of casual vacancies : 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 letter by the Chairperson after confirmation from the member concerned about his resignation.

(12) 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 step to have the vacancies filled by nomination or election, as the case may be.

(13) Finance and accounts : The accounts of the State Council shall be audited annually by a registered chartered accountant appointed by the Government. Any expenditure incurred in connection with such audit shall be payable by the Council.

4. Establishment of registering authority.— (1) The State Government shall by a notification under section 10 of the Act and in accordance with the rules framed by the Central Government in this behalf set up an authority to be called the District Registering Authority for registration of clinical establishments in the Union Territory.

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PART–II] LA GAZETTE DE L'ETAT

(2) Functions of the registering authority: The registering

authority shall perform the following functions, namely:-

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

clinical establishments.

(b) To enforce compliance of the provisions of the Clinical Establishments (Registration and Regulation) Act, 2010 and the rules made thereunder.

(c) To investigate complaints of breach of the provisions of the

Act or the rules made thereunder and take immediate action.

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

(e) To report to the State Council on a quarterly basis, on the action taken against the functioning of unregistered clinical establishments in violation of the Act and the rules.

(f) Perform any other functions as may be prescribed by the Central Government and/or the State Government from time to time.

(3) Powers of the registering authority : The District Registering Authority shall, for the purposes of discharging its functions under this Act, have the powers 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 documents

or other electronic records or other material objective produceable

as evidence;

(c) receiving evidence on affidavits;

(d) requisitioning of any public record;

(e) issuing commission for the examination of witnesses or

documents;

(f) reviewing its decision, directions and orders;

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

52 LA GAZETTE DE L'ETAT [PART–II

(h) imposing monetary penalty under the provision of the

section 41 and 42 of the Act.

(i) any other matter which may be prescribed.

(4) Meetings of registering authority: The meetings of the

registering authority shall be held once in a month at a stipulated date

and time.

(5) Conduct of business: Every meeting of the registering authority

shall be presided over by the Chairperson.

(6) Notice of meeting: 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.

(7) Quorum: One-third of the total number of members of the

registering authority shall form a quorum and all actions of the authority

shall be decided by a majority of the members present and voting.

(8) The proceedings of the meetings of the registering authority

shall be preserved in the form of minutes which shall be authenticated

after confirmation by the signature of the Chairperson.

(9) A copy the minutes of each meeting of the registering authority

shall be submitted to the Chairperson by the Member-Secretary within

5 days of the meeting and after having been attested by him/her shall

be sent to each members 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.

(10) Resignation and filling of casual vacancies: If a casual vacancy

occurs in the office, 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, in which he is so

appointed.

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PART–II] LA GAZETTE DE L'ETAT

5. Registration of clinical establishments.— (1) Application for registration. The applicant shall apply to the concerned registering authority, notified by the Government for provisional registration, either in person, or by post or through web based online facility with the necessary information in a format as per Form–'A'.

(2) The applicant shall apply to the concerned registering authority notified by the Government 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 as may be specified by the State Government.

(3) If an establishment is offering services in more than one category, the establishment will need to apply for a separate provisional or permanent registration for each category of establishment under section 14 (1) and section 30 of the Act. However, if a laboratory or diagnostic centre is a part of an establishment providing out-patient/in- patient care, no separate registration will be required.

(4) Acknowledgment of application: The registering authority or any person in his office authorized in this behalf, shall acknowledge receipt of the application for registration, in the acknowledgment slip in Form–'AA' immediately, if delivered at the office of the authority, or not later than the next working day, if received by post and by online acknowledgment to be generated automatically by the system.

(5) Grant of registration: The registering authority shall not undertake any enquiry prior to the grant of provisional registration and shall within a period of ten days from the date of receipt of such application, grant to the applicant a certificate of provisional registration containing particulars and information in Form–'R' either by post or electronically.

(6) Certificate of permanent registration: The District Registering Authority shall grant the applicant a certificate of permanent registration in form as specified by the State Government either by post or

electronically after satisfying itself that the applicant has complied with 54 LA GAZETTE DE L'ETAT [PART–II

all the requirements and criteria, including provisions of minimum

standards and personnel required to run the clinical establishment

prescribed by the Government and statutory requirements.

(7) In case of permanent registration, under section 29 of the Act,

the authority shall pass an order within the period prescribed hereunder:-

(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.

(8) Fees to be charged: The State Government may charge fees

for different categories of clinical establishments.

(a) The various fees to be charged for provisional and permanent

registration, renewal, late application, duplicate certificate, change

of ownership, management or name of establishment shall be

as in Form –'AB'.

(b) The clinical establishments owned, controlled and managed

by the Government (Central, State or local authority) or department

of Government shall be exempted from payment of fees for

registration.

(c) The fees prescribed for registration of various categories of

clinical establishments may be revised by the State Council through

a notification issued by the State Government.

(d) The fee shall be paid by a demand draft/online transaction

in favour of the registering authority concerned.

(e) The fees collected by the registering authorities for

registration of the clinical establishments shall be, deposited by

the authority concerned in a nationalised bank account opened in

the name of the official designation of the registering authority

concerned and shall be utilised by the authority for the activities

connected with the implementation of the provisions of the Act and

rules as approved by the District Registering Authority.

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PART–II] LA GAZETTE DE L'ETAT

(f) There shall be a constituted fund called 'The Puducherry Council for Clinical Establishments Fund' and all District Registering Authorities shall credit five per cent of the total amount collected by them by way of fees.

(g) The account shall be maintained as per the general financial rules and shall be audited by a registered chartered accountant notified by the Government and the annual reports shall be submitted to the State Council.

(h) In the event of any change of ownership or management, the establishment shall intimate to the District Registering Authority in writing within one month of such change along with the fees prescribed in Form–'AB' for issue of a revised certificate of provisional or permanent registration as the case may be, incorporating the changes and on surrendering the old certificate of registration.

(i) In the event of certificate of registration (provisional or permanent) being lost or destroyed, the owner shall apply to the District Registering Authority to issue a duplicate certificate upon payment of the fees prescribed in Form–'AB'.

6. 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 the Form–'AB' and penalty of ` 100 per day till the date of application for renewal.

(2) The clinical establishment shall apply for renewal of permanent registration three months before the expiry of the validity of the certificate of permanent registration. In case the application for renewal is not submitted with in the stipulated period, the authority will allow for renewal of registration on payment of amount as prescribed in Form–'AB' and penalty of ` 250 per day till the date of application for renewal.

(3) The renewal will be granted by the authority within 3 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.

56 LA GAZETTE DE L'ETAT [PART–II

7. Registers to be maintained, furnishing of returns and display

of information.—

Register to be maintained: (1) Every District Registering Authority shall within a period of two years from its establishment, compile, publish and maintain in digital format, a register of clinical establishments registered by it and shall enter the particulars of the certificates so issued in a register containing particulars as developed by national council.

(2) Every District Registering Authority including any other authority set up for the registration of clinical establishments under the law for the time being in force shall apply in digital format to the State Council for Clinical Establishments a copy of every entry made, in the District Register of Clinical Establishments for a particular month by the 15th day of the following month as required in section 37 (2) of the Act.

(3) Display of Information : The District Registering Authority shall, within a period of forty-five days from the 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 District Registering Authority will launch, the name of the clinical establishments, 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 required under section 16 (2) of the Act.

(4) The State Council could 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 section 16 (2) of the Act.

(5) The District Registering Authority shall, within a period of 7 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 District Registering Authority will launch, the name of the clinical establishments, 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.) and the details and information related to having complied with the minimum standards and personnel prescribed for the particular category of clinical establishment as required under section 26 of the Act.

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PART–II] LA GAZETTE DE L'ETAT

(6) The District Registering 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 Form–"O". 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 of any statutory requirement to the

District Registration Authority.

(7) The District Registering 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 required under section 21 and section 30 of the Act.

8. Maintenance of records and reporting 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 programmes and furnish the same to the concerned

programme officers periodically. The minimum medical records to be

maintained and nature of information to be provided by the clinical

establishments will be as per the format Form–"REG".

(2) Copies of all records and statistics shall be kept with the

clinical establishments concerned for at least 3 years or in accordance

with any other relevant Act in force at the time as required under

section 12 (1) (iii) of the Act.

(3) All clinical establishments shall be responsible for submission

of information and statistics in the time of emergency or disaster or

epidemic situation.

(4) The Government may notify from time to time, the nature of

information that needs to be furnished by the clinical establishments

including other diseases notified for this purpose along with the

prescribed interval.

9. Other conditions for registration and continuation of clinical

establishments.— (i) Each category of clinical establishments shall

comply with the standard treatment guidelines and maintain electronic

records of every patient as may be notified by the Central Government

from time to time.

58 LA GAZETTE DE L'ETAT [PART–II

(ii) Each category of clinical establishments shall charge the rates for each type of procedure and service within the range of rates to be notified by the State Government from time to time, for such procedures and services.

(iii) Every clinical establishment shall display the rates charged for each type of service provided and facilities available, for the benefit of the patients at a prominent place in the local language and as well as in English language. The minimum list of services for which rates are to be displayed are given in Form–RATE.

(iv) Every category of clinical establishments, as may be notified by the State Government from time to time, shall establish mechanisms for review and audit for the purpose of provision of rational practice and service and maintenance of high standards of quality.

(v) Each category of clinical establishments, as may be notified by the State Government shall carry out every prescription audits every 3 months.

(vi) Each category of clinical establishments, as may be notified by the State Government from time to time, shall carry out audit to assess the cause of death including treatments given to explore better preventive and management strategies.

(vii) In addition to the specific provisions of the Clinical Establishments (Registration and Regulation) Act, 2010 all establishments shall comply and maintain information and statistics in keeping with other applicable Acts and rules which are in force in this Union Territory.

10. Power to enter.— (1) Entry and search of the clinical establishment can be done by the District Registering Authority or an officer or team duly authorised 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 of the District Registering Authority.

(2) Such entry and search of clinical establishments can be conducted if anyone is carrying on a clinical establishment without registration or does not adhere to the prescribed minimum standards or there is reasonable cause to believe that the clinical establishments are being used for purposes other than that for which it is registered or 59

PART–II] LA GAZETTE DE L'ETAT

contravenes any of the provisions of the Act and rules and the authority

or the officer authorised by it 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 inspection team shall intimate the establishment in writing

about the date of visit and reasons for the inspection. The team shall

enter all portions of the premises used or proposed to be used for the

clinical establishments 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 enquiries as they consider necessary to verify the statements made

in the application for registration and grant of licence. All persons

connected with the running of the establishment shall be bound to

supply full and correct information to the inspection team.

(4) The officer and/or inspection team so constituted by the

registering authority shall submit a report as in Form–"IR" within a

week of the inspection to the District Registering Authority with a copy

to the State Council.

11. Cancellation of registration.— (1) If, at any time after any

clinical establishments 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 under

the Act should not be cancelled for the reasons to be mentioned

in the notice.

(2) 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.

60 LA GAZETTE DE L'ETAT [PART–II

(3) Every order made under sub-section (2) 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 on if there is imminent danger to the health and safety of patients.

12. Penalties.— (1) Whoever carries on a clinical establishment without registration or whoever willfully disobeys any direction, or obstruct any person or authority or withholds any such information or provides false information shall be liable for a monetary penalty, as prescribed for in the Act.

(2) Whoever carries on a clinical establishment without registration, shall, on first contravention be liable to a monetary penalty up to fifty thousand rupees, for second contravention to a monetary penalty which may extend to two lakh rupees and for any subsequent contravention to penalty which may extend to five lakh rupees.

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

13. Appeals.— (1) Any person or clinical establishment, if a g g r i e v e d b y t h e d e c i s i o n o f t h e a u t h o r i t y m a y f i l e a n a p p e a l in Form–"APL" to the State council within thirty days from the date of receipt of such order along with a fee of ` 5,000.

(2) After receipt of the appeal, the State Council shall fix 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.

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

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PART–II] LA GAZETTE DE L'ETAT

(4) 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.

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

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

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

(8) If no appeal is filed against the decision of the registering authority (i.e.) within 30 days from the date of receipt of the order, the orders of the authority shall be final.

(9) The penalty fees and appeal fees collected by the authorities shall be deposited by the authority concerned in a nationalised bank account opened in the name of the official designation of the 'Puducherry Council For Clinical Establishments' concerned and shall be utilised by the Council and authority for the activities connected with the implementation of the provisions of the Act as approved by the Council.

14. Provision of medical assistance at the time of natural calamity or disaster.— In case of any natural calamity or disaster, all the private clinical establishments shall provide such reasonable assistance and medical aid as may be considered essential at the time of natural calamity or disastrous situation.

15. Implementation of National Health Programmes.— All the private clinical establishments shall implement all the National Health Programmes launched by the Government of India from time to time and shall submit periodical reports to the health authorities concerned in the specified pro forma.

(By order of the Lieutenant-Governor)

V. JEEVA, Under Secretary to Government (Health).

62 LA GAZETTE DE L'ETAT [PART–II

FORM-'A'

GOVERNMENT OF PUDUCHERRY

DEPARTMENT OF HEALTH AND FAMILY WELFARE SERVICES APPLICATION FOR PROVISIONAL REGISTRATION OF CLINICAL ESTABLISHMENTS

[Section 14 (1) and 14 (3) of the Act]

1. Name of the establishment or : doctor (in case of single practitioner).

2. Address

:

PIN code :

Tel. No. (with STD code) : Mobile :

Fax

: e. mail :

Website (if any) :

3. Year of starting :

4. Location : Urban/Rural

5. Ownership of services :

(a) Public Sector

Central Government/State Government/Local Government Public Sector undertaking/Railways/Employee State Insurance Corporation (ESIC)/ Autonomous organisation/Society/Not for profit companies.

Any other (please specify) :

(b) Private Sector

Individual proprietorship/[Registered partnership/Registered company/Corporation (including a Society) registered under a Central, Provincial or State Act (please specify) :

Trust (including charitable) registered under a Central,

Provincial or State Act (Please specify) :

Branch of a Foreign Service provider (please specify)...................

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PART–II] LA GAZETTE DE L'ETAT

6. Name of the owner :

Address

:

PIN code :

Tel. No. (with STD code) : Mobile : Fax :

e.mail

:

7. N a m e , d e s i g n a t i o n a n d

qualification of person in-charge

of the clinical establishment—

Name of person in-charge :

Designation : Qualification :

Registration No. and name of :

the Council

Address

:

PIN code :

Tel. No.(with STD code) : Mobile : Fax :

e.mail

:

8. System of medicine offered :

(Please specify).

(i) Allopathy, (ii) Ayurveda (iii) Unani, (iv) Siddha,

(v) Homeopathy, (vi) Yoga and Naturopathy,

(vii) Any other (please specify):

9. Type of establishment: (Please tick whichever is applicable)

Clinic

Single practitioner/Polyclinic Medical Termination of Pregnancy

(MTP)/Dental/Mobile/Any other (please specify) :

64 LA GAZETTE DE L'ETAT [PART–II

Centre:

Sub-Centre Primary Health Community Health Urban Health Centre Centre. Centre. Counseling Centre Dispensary Day care Centre In Vitro Fertilization (IVF) Wellness Centre Dialysis Centre. Hospice Centre

Any other (like Refraction Audiometry, Prosthetic and Orthotic etc., please specify) :

Diagnostic Centre

Laboratory:

Pathology

Hematology Histopathology Cytology Genetics Sample Collection Centre.

Any other (please specify):

Biochemistry/Microbiology, Any other (please specify):................

Imaging Centre:

Portable X ray Conventional X ray

X ray with computerised Radiography Digital X ray system. Ultrasound

Ultrasound with color doppler. Mammography

CT Scan

Orthopentogram(OPG)/

Magnetic Resonance Imaging (MRI).

Positron Emission Tomography (PET) Scan. Bone Densitometry

Uro-flowmetry Any other (Please specify) :

Miscellaneous

Electro Cardio Graphy (ECG) Echo cardiography Tread Mill Test Electro Myo Graphy (EMG) Electro Encephalo Graphy (EEG) Electrophysiological studies Any other (please specify):

Blood banks

(A) Based on location

Stand alone Hospital based Any other (please specify):

65

PART–II] LA GAZETTE DE L'ETAT

(B) Based on facilities

Blood bank/Centre having whole blood facility only.

Blood bank/Centre having whole blood and component facility.

Blood bank/Centre having whole blood and/or component facility.

with any other additional facility (please specify): ........................

Hospital

General Practice Services Maternity Home

Clinic Specialty Services Multi Specialty Services

Super Specialty Services O p e r a t i o n T h e a t e r

E m e r g e n c y / C a u s a l i t y I C CU ICU

Any other please specify): ....................................................

Sanatorium

Any other (please specify): ....................................................

SYSTEM OF MEDICINE

10. Services offered (please tick whichever is applicable)

(a) Allopathic

Specialty

Medical Surgical Obstetrics and Gynaecology Paediatrics

Any other please specify :......................................

(b) Ayurveda

Ausadh Chikitsa Shalya Chikitsa Shodhan Chikitsa Rasayana

Pathya Vyavastha.

Any other please specify: .........................................................

(c) Unani

Matab Jarahat Ilaj-bit-Tadbeer Hlfzan-e-Sehat

Any other please specify: ........................................................

(d) Siddha

Maruthuvam Sirappu Maruthuvam Varmam Thokknam and Yoga

Any other please specify : .........................................................

66 LA GAZETTE DE L'ETAT [PART–II

(e) Homoeopathy

General Homeopathy

Any other please specify :...........................

(f) Naturopathy

External Therapies with natural modalities Internal Therapies

Any other please specify: .........................................................

(g) Yoga

Ashtang Yoga

Any other please specify: ............................

INFRASTRUCTURE DETAILS:

11. Area of the establishment (in Sq. meters):

(a) Total area :...................... (b) Constructed area:.......................

12. Out-patient Department

12.1 Total No. of OPD clinics : .....................................................

13. In-patient Department:

13.1. Total number of beds: ..................................

13.2. Specialty-wise distribution of beds, please specify: ...............

67

PART–II] LA GAZETTE DE L'ETAT

14. Bio-medical waste management

14.1. Method of treatment and/or disposal of Bio-medical waste

Through common facility Onsite facility

Any other please specify: ..................................................

14.2. Whether authorisation from Pollution Control Board/ Pollution Control Committee obtained?

Yes No Applied for Not applicable

HUMAN RESOUCES :

15. Total number of staff (as on date of application):

No. of permanent staff : ............. No. of temporary staff :...........

Please furnish the following details:-

Separate annexure may be attached.

16. Payment option for registration fees:

Online payment Demand Draft Postal Order

Any other (please specify): .........................................

Amount (in `): .............................................................

Details : ...............................

Receipt No : ........................

68 LA GAZETTE DE L'ETAT [PART–II

I hereby declare that the statements above are correct and true to

the best my knowledge and I shall abide by all the rules and declarations

under the Clinical Establishments Registration and Regulation) Act, 2010.

I undertake that I shall intimate to the appropriate registering

authority any change in the particulars given above:

Place: Signature of the authorised signatory

Office seal.

Date:

————

FORM - 'AA'

GOVERNMENT OF PUDUCHERRY

DEPARTMENT OF HEALTH AND FAMILY WELFARE SERVICES

REGISTRATION OF CLINICAL ESTABLISHMENT

ACKNOWLEDGMENT FOR RECEIPT OF APPLICATION

[See rule 5(4)]

The application for grant/renewal of Provisional/Permanent

Registration of the Clinical Establishment submitted by.....................

.......................................................................................................................

(Name and address of owner) has been received by the District

Registering Authority on ...................................... (date) and found to be

complete or incomplete.

This acknowledgment does not confer any right on the applicant

for grant or renewal of registration.

Signature and designation of

Seal :

Date :

registration authority or any authorised

person by the registering authority.

69

PART–II] LA GAZETTE DE L'ETAT

FORM - 'AB'

GOVERNMENT OF PUDUCHERRY

DEPARTMENT OF HEALTH AND FAMILY WELFARE SERVICES

FEES TO BE PAID FOR REGISTRATION/ RENEWAL OF CLINICAL ESTABLISHNMENT

[Sections 14 (1), 19, 20(2), 24 and 35 of the Act]

Diagnostic/Testing

70 LA GAZETTE DE L'ETAT [PART–II

Other fees :

* For renewal same amount of registration fee (provisional/permanent). * For late application the amount would be double of the registration

fee (provisional/permanent) along with penalty.

* For duplicate certificate the amount would be ` 500. * For change of ownership, management or name of establishment would

as that of registration fee.

* For any appeal the amount would be ` 5,000.

If a laboratory or diagnostic centre is a part of a establishment providing

out-patient/ in-patient care no separate registration is required.

————

FORM-'R' GOVERNMENT OF PUDUCHERRY

DEPARTMENT OF HEALTH AND FAMILY WELFARE SERVICES

PROVISIONAL CERTIFICATE FOR REGISTRATION

OF CLINICAL ESTABLISHMENT

[Section 15 of Act and rule 5(5)]

Provisional Registration No:

Date of issue :

Valid up to :

1. M/s./Doctor ...............................................(name of the clinical establishment) operating from...................................(complete address) as .............................................................................................................. ..............................................(type of clinical establishment) is hereby provisionally registered under the provision of Clinical Establishment (Registration and Regulation) Act, 2010 to provide service under ......................system of medicine with ............................(bed strength).

2. This authorisation is subject to the conditions stated and to such other conditions as may be specified in the rules in force under the Clinical Establishments (Registration and Regulation) Act, 2010.

Name and designation

of the registering authority:

Place : Date :

Terms and conditions of registration*

1. The holder of this certificate of registration shall comply with all the provisions of Clinical Establishment (Registration and Regulation) Act, 2010 and the rules made thereunder.

71

PART–II] LA GAZETTE DE L'ETAT

2. The certificate of registration is not transferable.

3. Any change of ownership or change of category or change of management or on ceasing function as a clinical establishment, the certificate of registration shall be surrendered to authority and application for fresh registration may be submitted.

4. The certificate of registration shall be displayed in a prominent

place in a part of the premises open to public.

* Additional terms and conditions are as stipulated by the

appropriate registering authority.

————

FORM - 'O'

GOVERNMENT OF PUDUCHERRY

DEPARTMENT OF HEALTH AND FAMILY WELFARE SERVICES

REGISTRATION OF CLINICAL ESTABLISHMENT DISPLAY OF INFORMATION FOR FILING OBJECTIONS

[Section 26 and see rule 7(3)]

I, ....................................................... being the District Registering 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 Establishment Act, 2010 and the Clinical Establishment Rules, 2014 made thereunder, hereby publish the list of clinical establishments; within the jurisdiction of ........................... district.

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.

Place:

Signature:

Date:

Name:

(Seal of the authority)

72 LA GAZETTE DE L'ETAT [PART–II

FORM-'IR'

SUGGESTED FORMAT FOR SUBMISSION OF

INSPECTION REPORT

[Section 33 and see rule 9(4)]

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—

To the Clinical Establishment

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).

Place :

Date :

73

PART–II] LA GAZETTE DE L'ETAT

FORM - 'APL'

[Section 36(2) of Act and rule 12(1)]

To

The Member-Secretary,

Puducherry Council for Clinical Establishments,

Government of Puducherry

Sir,

I, ........................................................................... had applied

for registration under Clinical Establishments Act, 2010 for ................

(name of the establishment) .............................................................

.....................................................................located at .................................

(address of the establishment)

I, ....................................................... owner of the .................. of the

establishment (name of the establishment) ......................................

located at ............................................. is a valid licence holder with

Registration No. ................................ under the Clinical Establishment

Act, 2010.

I was communicated by the District Registering Authority vide

Order No. ................................., dated ................... that either;

(i) That my application was rejected

(ii) That my registration is cancelled

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

74 LA GAZETTE DE L'ETAT [PART–II

The above decision of the District Registering Authority appears to be not valid and I request to consider my application as per the justification 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 ` 5,000.

Thanking you

Place:

Signature :

Date: Name :

Name of the Clinical Establishment :

(1) Address

:

(2) Owner of the clinical establishment :

(3) Name of person in-charge :

(4) System of medicine :

(5) Type of establishment :

is hereby provisionally registered under the provisions of Clinical Establishments (Registration and Regulation) Act, 2010 and the rules made thereunder.

This authorisation 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 thereunder.

Place : Designation of the issuing authority:

Date :

District Registration Authority Address:

Phone number in case of grievances 75

PART–II] LA GAZETTE DE L'ETAT

FORM - 'REG'

RECORDS TO BE MAINTAINED BY CLINICAL

ESTABLISHMENTS

The various medical records to be maintained by the clinical

establishment are as follows:-

* Out-patient register

* In-patient register

* Operation Theatre register

* Labor room register

* MTP register (If register under the MTP Act)

* Case sheets

* Medico-legal register

* Laboratory register

* Radiology and imaging register

* Discharge summary

* Medical certificate in duplicate

* Complaint register

* Birth register

* Death register (in such format as prescribed by Government)

* Information in terms of Government programme/areas of work

(e.g., maternal health, child health, immunisation, family planning, vector

borne disease, NLEP, RNTCP, IDSP, NRHM initiatives-ASHA, JSY).

* Number of beds system-wise and specialty-wise providing

in-patient care (e.g. General Bed/Surg Beds, Special Care Beds)

* Total discharges.

76 LA GAZETTE DE L'ETAT [PART–II

FORM- 'RATE'

MINIMUM LIST OF SERVICES FOR WHICH RATES ARE TO BE DISPLAYED

Name of the service Type of service Charges

(in `)

(1)

(2)

(3)

Room Charges: General services (includes room/bed charges, Private rooms: Nursing charges, Medical Semi Deluxe - shared Utilities charges). Deluxe with AC.

Intensive Care Units: MICU & ICU (Charges include the ICU NEURO bed charges, medical utilities, POW monitoring and nursing Neonatal ICU charges). Paediatrics ICU

OT Charges :

General Anesthesia ½ hour General ward twin/triple

sharing.

General Anesthesia 1 hour General ward twin/triple

sharing.

Local Anesthesia ½ hour

1 hour

Surgical procedures charges General surgical procedures (package) (includes surgeon Ob & Gy procedures charges+Anesthetist charges* Orthopaedic surgical procedures Nursing home charges and Cardiac surgical procedures in-patient medicine charges).

Doctor consultation charges: OP Specialist

Super Specialist.

IP Per visit

Emergency visits Per visit

Emergency care team charges 3 shift per day 77

PART–II] LA GAZETTE DE L'ETAT

(1)

(2)

(3)

`

Diagnostic charges

Common diagnostic tests X-ray per film

Ultra sound, General and Abdomen

Obstetrics care Female pelvic

KUB

CT Scan: Brain Plain

Multi slice/ Spiral /CT Scan Chest/Abdomen/Neck/

Spine.

MRI 0.5/1/1. 5 Brain (Magnetic Resonance Chest Imagin) Contast

ECG/TMT/ECHO/EMG/EEG

Upper GI Endoscopy/Lower GI Endoscopy

Lab. investigation

Random blood sugar

Serum creatinine

CBP/ESR/CUE

Blood Group

Blood for MP

LFT

Lipid profile

HBSAG/VDRL/HIV

Electrolytes T3,T4,TSH

Any other items (not included above).

Note: Other service charges for in-patient such as drug and disposables, investigation and concession, if any, shall be displayed at appropriate places for the benefits of the patient.

78 LA GAZETTE DE L'ETAT [PART–II

CG3 ANNEXURE

State/District Register for Clinical Establishment

Details of Information Required

(A) At State/District level:

Total number of establishment by

- Category

- System of medicine practiced

- Type of service provided

- Rural/Urban

- No. of beds

Number of clinical establishments increased or decreased

Number of inspections carried out

Number of pending application with reasons

Action taken against non-register establishments operating in

violation of the Act.

Complaint received by the State Council under the Act and action taken

pursuant thereto.

(B) Detailed information

Details of each clinical establishment by

Name

Location containing details

Rural/ Urban/Metropolitan

Village/Town

Taluka

District

State

PIN code

Phone number 79

PART–II] LA GAZETTE DE L'ETAT

e-mail ID:

Ownership details

Name of owner

Educational qualification

Person in-charge of clinical establishment

Education qualification

Urban/Rural designation

Longitude/Latitude systems of medicine offered

Type of establishments by category specified under section .............

of the ..............rules. Nature of service provided by category specified

under section ..............of the...............rules.

Number of beds system-wise and specialty-wise in clinical

establishments providing in-patient care.

Total employees.

Total discharging:

Average length of stay (OP/IP)

Utilisation statistics

Details of staff with name, qualification, Registration number,

temporary or permanent.

————

online publication at "http://styandptg.puducherry.gov.in"

Government Central Press Directorate of Stationery and Printing Puducherry-9.