M K SHARMAMBA

A Commentary on

THE CLINICAL ESTABLISHMENTS REGISTRATION & REGISTRATION BILLL

OF 2006.

Section 3 (iii)a Clinical Establishments means and includes:

A hospital, maternity homes, nursing home, dispensary, clinic, sanatorium

or an institution by whatever name called that offers services, facilities with beds

requiring diagnosis, treatment or care for illness, injury, deformity, abnormality or pregnancy

in any recognized system of medicine

Section 3 (iii) b Clinical Establishments means and includes:

A place established as an independent entity or part of an establishment as defined in (a) above

in connection with the diagnosis or treatment of diseases

where pathological, bacteriological, genetic,

radiological, or chemical, biological investigations or other diagnostic

or investigative services with the aid of laboratory or other medical equipment, are usually carried on.

Section 3 (iii) Clinical Establishments means and includes:

Establishment and administered or maintained by any person or body of persons, whether incorporated or not,

but does not include a clinical establishment established and administered or maintained by the State Government or a local authority.

Act:To stabilize the emergency

patient

(with its grammatical variations and cognate expressions) 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 medical probability, that no material deterioration of the condition is likely to result from or occur during the transfer of the individual from one clinical establishment to other.  

The Act

Section 4: REGISTRATION ESSENTIAL FOR ALL CLINICAL ESTABLISHMENTS

No person shall carry on a Clinical Establishment unless it has been duly registered in accordance with the provisions of this Act.

Explanation: This expression ‘carry on’ means to receive patients in a clinical establishment for providing treatment, diagnosis or nursing care.

EVERY Clinical Establishment shall fulfill for registration and

continuation of it such conditions under this Act as the State Government may prescribe may among others

include standards for facilities and services, qualification of personnel, maintenance of records, and incident reporting.

Section5: CLINICAL ESTABLISHMENTS TO BE MAINTAINED IN ACCORDANCE WITH PRESCRIBED CONDITIONS

(i) Clinical Establishments shall be classified into such

categories as may be prescribed by the State Government from time to time.

(ii) Different standards may be prescribed for categories so classified in sub section (i) above

Section6: CLASSIFICATION OF CLINICAL ESTABLISHMENTS

Sec 7, 8. The C.M.&H.O. of the district shall be the District Registrar of Clinical Establishments, for purposes of grant of registration under this Act.

Sec 10 Every State Government shall designate the Director Medical & Health Services (H.A) or any other officer subordinate to him as the Registrar of Clinical Establishments. Sec11. Responsibility of the Registrar of Clinical Establishments to compile and update the State Register of Clinical Establishments and further to send monthly returns in digital format for updating the State register.

CLINICAL ESTABLISHMENTS REGISTRATION AUTHORITY

12 (I): There shall be a State Council for

determining standards for Clinical Establishments to be constituted by the State Government for: a. The Classification of clinical establishment into different

categories,

b. Developing minimum standards and their periodic review;

c. Compiling, maintaining and updating a State register of clinical establishments.

d. Performing any other function determined by the State Government from time to time.

Section12: STATE COUNCIL FOR CLINICAL ESTABLISHMENTS

(a) DM&HS - ex-officio, who shall be the chairman. (b) One representative each to be elected by the

Executive Committee of : i. Rajasthan Medical Council ii. Rajasthan Nursing Council iii. Rajasthan Pharmacy Council (c) Three representatives to be elected by the

Executive of the State Council of Indian Medicine representing the Ayurveda, Sidha, and Unani systems of medicine.

(d) One representative to be elected by the State Council of the Indian Medical Association.

Section12 (ii) : The State Council shall consist

(e) One representative from the Hospital Owners Association.

(f) One representative of Bureau of Indian Standard.

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

(h) The State Government may nominate not more than three eminent representatives of other recognized systems of medicine of which no statutory regulatory authority has been set up.

(i) One representative from State level consumer groups. The nominated of the Council shall

hold office for one year, but shall be eligible for re-nomination.

Section12 (ii) : The State Council shall consist- contd

15. The State Council shall follow a consultative

process for determining standards and for classification of Clinical Establishments as per procedure to be prescribed in the regulations.

Section15: STATE COUNCIL TO FOLLOW CONSULTATIVE PROCESS

16. i. For the purpose of registration of the clinical

establishment, an application in the prescribed Performa along with the prescribed fee shall be submitted to the prescribed authority. online submission accompanied with such details as may be prescribed under this Act or rules/regulations made there under.

v. An application for its registration shall be made within one year form the date of the commencement of this Act.

vi. If any clinical establishment is already registered under any existing law requiring registration of such establishments, even then it would have to apply for registration as prescribed at (i) above.

Section 16: PROCEDURE FOR REGISTRATION

As-is-where-is'

Initially, provisional registration would be granted within 30 days of application on ‘as-is-where-is basis' upon receiving the application filed with supporting documents.

Once standards have been notified, permanent registration would be provided to all those conforming to the notified standards.

18. i. The authority shall not be required to

conduct any enquiry prior to the grant of provisional registration.

ii. Notwithstanding the grant of the provisional certificate of registration, the authority shall within a period of forty-five days from the grant of provisional registration, cause to be published in such manner as may be prescribed, all particulars of the clinical establishment proposed to be registered

Section 18: NO ENQUIRY PRIOR TO PROVISIONAL REGISTRATION

Sec 20. The Certificate shall be kept affixed in a conspicuous place in the clinical Establishment in such a manner so as to be visible to every one visiting such establishment.

Sec 26. Permanent registration shall be granted only after the State Government has prescribed minimum standards for the registration of clinical establishments.

Section20: DISPLAY OF THE CERFTIFICATE OF REGISTRATION

39. (i) The authority or an officer authorized by it may if there is any reason to suspect that anyone is carrying on a clinical establishment without registration enter and search in the manner prescribed, at any reasonable time and the clinical establishment shall offer reasonable facilities for inspection and or inquiry and be entitled to be represented thereat.

40. all appeals against the orders of the registering authority shall like to the Joint Director Medical & Health having jurisdiction over the district.

Section 39: INSPECTION OF UNREGISTERED CLINICAL ESTABLISHMENTS

47 (i) Whosoever carries on a Clinical Establishment without registration shall on conviction for first offence be punishable with a fine up to fifty thousand rupees, for second offence (non-registration) with fine that may extend to two lakh rupees and for any subsequent offence with fine that may extend to five lakhs of rupees.

(ii) Any person, who knowingly serves in a Clinical Establishment that is not duly registered under this act, shall be guilty of an offence and shall be punishable with fine that may extend to twenty five thousand rupees.

Section 47: OFFENCES RELATING TO NON-REGISTRATION

48. (i) Whoever, willfully disobeys any direction lawfully given by any person or authority empowered under this Act to give such direction, or obstructs any person or authority in the discharge of any functions which such person or authority is required or empowered under this Act to discharge, shall be punishable with fine that may extend to five lakh rupees.

(ii) whoever, being required by or under this Act to supply any information which he knows to be false or which he does not believe to be true, shall be punishable with fine that may extend to five lakh rupees.

Section48: DISOBEDIENCE OF ORDER, OBSTRUCTION AND REFUSAL OF INFORMATION

49. (i) Whosoever contravenes any provision of this act or any rule, regulation or notification made there under resulting in deficiencies that do not pose any imminent danger to the health and safety of any patient and can be rectified within a reasonable time, shall be punishable with fine that may extend to ten thousand rupees.

(ii) All offences under this section shall be compoundable and shall be tried summarily in accordance with the procedure provided for summary trials in the Code of Criminal Procedure, 1973.

Section 49: DEFICIENCIES MINOR IN NATURE

50. (i) Where any offence punishable under this Act has been committed by a company, every person who, at the time the offence was committed, was incharge of, and was responsible to the company for the conduct of its business,

shall be deemed to be guilty of the offence and shall be liable to be proceeded against and punished accordingly.

Section 50: OFFENCES BY COMPANIES

50. (ii) …where any offence punishable under this Act has been committed by a company and it is provided that the offence has been committed with the consent or connivance of, or is attributable to any neglect on the part, of any director, manager, secretary or other officer of the company,

such director, manager, secretary or other officer shall also be deemed to be guilty of that offence and shall be liable to be proceeded against and punished accordingly.

Section 50: OFFENCES BY COMPANIES

51. (i) No suit, prosecution or other legal proceedings shall lie against any authority or any member of the State Council or any officer authorized in this behalf in respect of anything, which is in good-faith done or intended to be done in pursuance of the provision of this Act or any rules or regulations made there under.

Section 51: PROTECTION OF ACTION TAKEN IN GOOD FAITH

52. No court shall entertain any suit, application or other proceeding in respect of any order made under this Act and no such order shall be called in question otherwise than by way of an appeal under this Act.

Section 51: BAR TO THE JURISDICTION OF COURTS

f. The registers to be maintained under sections 40,41 and 42.

g. The conditions of registration under section h. The information for facilities, services etc. under

section 6. i. The information to be displayed by the Clinical

Establishment for public information. j. The manner and period within which the reporting

is to be done under section. k. The procedure for inspection of Clinical

Establishment under section 38 and 39. l. Classification of clinical establishment under

section 6.

Section 56: POWER OF THE CENTRAL GOVERNMENT TO MAKE RULES