Preamble [Act No. 02 of 2018]

PREAMBLE

An Act to provide for the registration and regulation of clinical establishments rendering services in recognised systems of medicine in the State and for matters connected therewith or incidental thereto.

Whereas, it is expedient to provide for the registration and regul

S.1 Short title and commencement

(1) This Act may be called the Kerala Clinical Establishments (Registration and Regulation) Act, 2018.

(2) It shall come into force on such date as the Government may, by notification appoint and different dates may be appointed for different recognized system of medicines.

S.2 Definitions

In this Act, unless the context otherwise requires,--

(a) "Appellate Authority" means the Appellate Authority constituted under sub-section (1) of section 34;

(b) "Authority" means a District Registering Authority constituted under sub-section (1) of section 14;

(c) "clinical establishment" means,--

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

(2) The Council shall consist of the following members, namely:--

(1) The Council shall carry out the following functions, namely:--

(a) determine, within a period of two years from the commencement of this Act, the first set of standards for ensuring proper healthcare by the clinical establishments;

(b) classify and catego

S.5 Secretary and oilier employees of the Council

(1) The Government shall appoint an officer not below the rank of Deputy Director of Health Department to be the Secretary of the Council.

(2) The Council may, with the permission of the Government, employ such employees as arc necessary for its proper functioning.

S.6 Power to seek advice or assistance

(1) The Council may associate itself with any person or body and obtain technical assistance or advice as it may deem necessary for carrying out the provisions of this Act.

(2) The Council may appoint such sub-committees as it deems fit, with members or persons who are not members of the Council, for such period, not exceeding two years, for the consideration of any particular matter under this Act or such other matter as may be prescribed.

S.7 The Council to follow consultative process

The Council shall follow a consultative and transparent process, including public hearing in such places as may be determined by the Council, with adequate notice for making suggestions for altering the mandatory standards and classification of clinical establishments and any other matter under the provisions of this Act and the rules.

S.8 Executive Committee

The Council shall have an Executive Committee consisting of the following members, namely:--

(i) Secretary, Health and Family Welfare Department, who shall be the Chairperson;

(ii) Secretary, Ayush Department, who shall be the Vice-Chairperson;

The Executive Committee shall exercise such powers and perform such functions as may be prescribed.

S.10 Vacancy etc. not to invalidate the proceedings of the Council

No act or proceedings of the Council shall be invalid on the ground merely of the existence of any vacancy or defect in the constitution of the Council.

S.11 Procedure and conduct of business

The quorum and the procedure for the conduct of business to be transacted in the meetings of the Council shall be such as may be prescribed.

S.12 Register of Clinical Establishments

(1) The Council shall compile, maintain and publish a register to be known as the State Register of Clinical Establishments in such form containing such particulars as may be prescribed.

(2) The Secretary of the Council shall be responsible for compiling and updating the State Register of Clinical Establishments.

S.13 Categories and standards

(1) Different standards shall be prescribed by the Government for clinical establishments of different categories and registration shall be granted to the establishments that have standards in each category.

(2) The Council shall determine, within a period of two years from the date of commencement of this Act, the first set of standards for ensuring proper healthcare in clinical establishments.

S.14 Authority for registration

(1) The Government shall, by notification, constitute an Authority for each District for registration of clinical establishments with the following members, namely:--

(a) District Collector, ex-officio--Chairperson;

(b) District Medical Officer (Health), ex-

S.15 Section 15 - Conditions for registration

Every Clinical Establishment shall fulfill the following conditions for the purpose of registration, namely:--

(a) shall have the standards according to the category of clinical establishment;

(b) the medical and paramedical staff shall have the minimum qual

S.16 Registration of clinical establishments

(1) All clinical establishments in Kerala shall be registered with the Authority concerned under the provisions of this Act and the rule's made there under.

(2) No person shall run a clinical establishment unless it has been duly registered in accordance with the provisions of this Act and the rules made there under.

(1) Every clinical establishment functioning on the date of commencement of this Act shall apply for provisional registration in such form along with such fee, as may be prescribed.

(2) All clinical establishments, whether registered or not under any existing law requiring registration of such establishments, shall apply for registration as referred to in sub-section (1)

S.18 Validity of provisional registration

Provisional registration shall be valid for a period of two years from the date of issuance of the certificate of registration.

S.19 Application for permanent registration of a clinical establishment

(1) Application for permanent registration of a clinical establishment shall be made to the Authority in such form and in such manner with such fees as may be prescribed, accompanied by such evidence to the effect that the clinical establishment has complied with the standards prescribed for the category.

(2) Every clinical establishment having provisional registration s

S.20 Validity of permanent registration

Permanent registration shall be valid for a period of three years following which it may be renewed prior to expiry on payment of such fees as may be prescribed.

S.21 Renewal of permanent registration

Application for renewal of permanent registration shall be made sixty days prior to the expiry of the validity of the certificate of permanent registration and in case the application for renewal is made after the expiry of such date, the Authority may allow such application on payment of such enhanced fees as may be prescribed.

S.22 Acknowledgment of application

The Authority shall acknowledge the receipt of the application for provisional registration or permanent registration, as the case may be, in such form as may be prescribed.

S.23 Certificate of registration

(1) The Authority shall issue the certificate of provisional or permanent registration, as the case may be, in such form and containing such particulars as may be prescribed.

(2) The provisional or permanent registration certificate shall be displayed in a conspicuous place in the clinical establishment.

S.24 Certificate of registration to be non-transferable

(1) The certificate of registration both provisional and permanent shall be non-transferable.

(2) In the event of change in the name of the establishment, ownership, category, management, location or on the cessation of functioning, such clinical establishment shall return the certificate within thirty days to the Authority.

(3) Where the registration certificate of a clinical establishment is returned under sub-section (2), fresh appl

S.25 Cancellation of registration

(1) If, at any time, after any clinical establishment has been registered, the Authority or the Council is satisfied that,--

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

(b) the clinical establishment has knowingly or negligently carried out an act that is harmful to the health of the person seeking care from the clinical establishment.

(1) The Council under this section, and the Authority under other sections of this Act, as the case may be, shall have power to adjudicate upon, enquire and impose penalty regarding contravention of the provisions of this Act and shall exercise such powers and follow such procedures as may be prescribed.

(2) Whoever contravenes any of the provisions of this Act shall, if penalty is not provided elsewhere, be liable for the first contravention to a monetary penalty which may extend to ten thousand rupees, for the second contravention a monetary pe

S.27 Penalty for non-registration

(1) Whoever carries on a clinical establishment without registration shall, for the first contravention, be liable to a monetary penalty which may extend to fifty thousand rupees, for the second contravention to a monetary penalty which may extend to two lakh rupees and for any subsequent contravention to a monetary penalty which may extend to five lakh rupees and in case of continuing contravention a monetary penalty of ten thousand rupees for every additional day the clinical est

S.28 Disobedience of order, obstruction and refusal of information

(1) Whoever willfully disobeys any direction lawfully given by the Authority, the Council or any person empowered under this Act to give such direction, or obstructs any person or the Authority or the Council in the discharge of any function which such person or the Authority or the Council is required or empowered under this Act to discharge, shall be liable to a monetary penalty which may extend to one lakh rupees.

(2) Whoever being required by or under this Act to supply any information willfully withholds such information or gives information

S.29 Penalty for minor deficiencies

Whoever contravenes any provision of this Act or any rule 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 liable to a monetary penalty which may extend to ten thousand rupees.

S.30 Contravention by companies

(1) Where a contravention under this Act has been committed by a company, every person who at the time of such contravention, was in charge of, and was responsible to the company for the conduct of the business of the company, as well as the company, shall be deemed to be guilty of the contravention and shall be liable to be proceeded against and punished accordingly:

P

S.31 Offences by Government Departments

Where an offence under this Act has been committed by any clinical establishment under the control of the Government, the officer responsible for that clinical establishment shall be deemed to be guilty of the offence and shall be liable to be proceeded against and punished accordingly:

Provided that nothing contained in this section shall render such officer liable to any punishment if he proves that the offence was committed without his knowledge or that he has exercised all due diligence to prevent the commission of such offence.

S.32 Fees, fines and penalties to be credited to separate account

The amount collected by way of fees, fines and penalties by the Council and the Authority shall be credited to such separate account as the Government may, by order, specify in this behalf and shall be utilized for the activities connected with the implementation of the provisions of this Act.

S.33 Eligibility for allowances

The non-official members of the Council and Authority, members of the grievance redressal committee, assessors and members of the sub-committee shall be eligible for such allowances as may be prescribed.

S.34 Appeals

(1) The Government shall, by notification, constitute an Appellate Authority to receive and adjudicate the appeals against the decision of the Authority with the following members, namely:--

(a) Secretary, Health and Family Welfare Department, (ex-officio)--Chairperson;

Any person aggrieved by the order of the Appellate Authority may prefer revision before the High Court within sixty days from the date of order of the Appellate Authority.

S.36 Grievance redressal

(1) The Council shall set up a grievance redressal mechanism in such manner as may be prescribed, to receive complaints from the public regarding the violation of the provisions of this Act or the rules made there under, by any clinical establishment and shall give direction to the authority to take appropriate action on the complaints so received.

(2) Notwithstanding an

S.37 Inspection

(1) The Council or the Authority or the Appellate Authority or any officer authorised by them, shall have the right to cause an inspection of, or inquiry in respect of any clinical establishment, its building, laboratories, diagnostic facilities, equipments and also the works conducted or done by the clinical establishment, to be made by such person or persons as they may direct and to cause an inquiry to be made in respect of any standards or conditions of the registration, after

S.38 Power to enter and search

The Council or the Authority or any officer authorised by them may, if there is any reason to suspect that anyone is carrying on a clinical establishment without registration, enter and search at any reasonable time, in such manner as may be prescribed, and the clinical establishment shall offer reasonable facilities for inspection or inquiry and be entitled to be represented thereat.

S.39 Display of the certificate of registration and other information by the clinical establishment

(1) Every clinical establishment shall display, in a conspicuous place in the clinical establishment its certificate of registration, provisional or permanent.

(2) Every clinical establishment shall display, in a conspicuous place in the clinical establishment in Malayalam as well as in English the fee rate and package rate charged for each type of service provided and f

S.40 Maintenance of medical records

Every clinical establishment shall maintain medical records of patients, in accordance with the laws for the time being in force, regarding the diagnosis, result of investigations, treatment given, condition at the time of discharge and advice given to the patients and a copy thereof shall be made available to the patient or to relatives free of cost.

S.41 Display of Information by the Authority

(1) The Authority shall, within a period of thirty days from the grant of provisional or permanent registration, cause to be published in such manner as may be prescribed, the particulars of the clinical establishment.

(2) The Authority shall cause to be published in the website of Kerala Clinical Establishment Council the names of clinical establishment whose provisional or permanent registration has expired, canc

S.42 Protection of action taken in good faith

(1) No suit, prosecution or other legal proceedings shall lie against any member or employee or any other officer authorised by the Authority or the Council in respect of anything, which is done in good faith or intended to be done in pursuance of the provisions of this Act or the rules made there under.

(2) No suit or other legal proceedings shall lie against the Author

S.43 Recovery of penalties

Penalties imposed under this Act and remaining unpaid shall be recovered as if it were an arrear of public revenue due on land.

S.44 Power to give directions

Without prejudice to the foregoing provisions of this Act, the Government shall have the power to give directions for the implementation of the provisions of the Act and to call for returns, statistics and other information that has relevance on public health and health surveillance.

S.45 Employees of the Authority and Council to be public servants

Every employee of the Council and the Authority while acting or purporting to act under the provisions of the Act or any rules made thereunder shall be deemed to be public servants within the meaning of section 21 of the Indian Penal Code, 1860 (Central Act 45 of 1860).

S.46 Bar of jurisdiction of civil courts

No civil court shall have Jurisdiction to settle, decide or deal with any question or to determine any matter or to interfere with any order which is by or under this Act required to be settled, decided or dealt with or to be determined or to be issued by the Authority or the Council or any officer authorised by them.

S.47 Treatment of victims in emergencies

(1) The clinical establishment shall provide, such medical examination and treatment as may be required and can be provided with the staff and facilities available in the establishment, to save the life of the patient and make the safe transport of the patient to any other hospital.

(2) The Council shall notify the life saving services to be provided by each category of

S.48 Term of office, casual vacancies, resignation etc., of members of the Council and Authority

(1) The term of office of non-official members of the Council and the Authority shall be three years from the date of notification of their nomination and shall not hold office for more than two terms.

(2) A casual vacancy of a non-official member shall be filled by new nomination by the Chairperson and the member so appointed shall hold office for the

S.49 Disqualification for membership

A person shall be disqualified for being appointed as a member of the Council or Authority if he,--

(a) is declared to be an undischarged insolvent; or

(b) becomes unsound mind and stands so declared by a court of competent jurisdiction; or

(1) The Council shall prepare for every year a report of its activities under this Act during that year and submit the report to the Government in such form and at such time as may be prescribed.

(2) The Government shall, as soon as possible, after the receipt of the report under sub-section (1), cause the same to be laid before the Legislative Assembly.

S.51 Power to remove difficulties

(1) If any difficulty arises in giving effect to the provisions of this Act, the Government may, by order published in the official gazette, make provisions which appear to them to be necessary and not inconsistent with the provisions of this Act for the purpose of removing the difficulty:

Provided that no such order shall be made after the expiry of a period of two years from the date of commencement of this Act.

(2) Every order issued under this section shall, as soon as may b

S.52 Power to make rules

(1) The Government may, by notification, make rules for carrying out all or any of the provisions of this Act.

(2) In particular, and without prejudice to the generality of the foregoing powers, such rules may provide for all or any of the following matters, namely:--

(a) the types of diagnosis under clause (c) of section 2;

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