KERALA CLINICAL ESTABLISHMENTS (REGISTRATION AND REGULATION) ACT, 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 regulation of clinical establishments with a view to prescribe standards of facilities and services which may be provided by them for the improvement of public health;
Be it enacted in the Sixty-ninth Year of the Republic of India as follows:--
(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.
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,--
(i) a hospital, maternity home, nursing home, clinic, sanatorium or an institution, by whatever name called, that offers services, facilities with or without beds requiring treatment, diagnosis, or care for illness, injury, deformity, abnormality, dental care, pregnancy or infertility 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
(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:--
(a) Secretary, Health and Family Welfare Department, ex-officio, who shall be the Chairperson;
(b) Secretary, Ayush Department, ex-officio, who shall be the Vice-Chairperson;
(c) Director of Health Services, ex-officio;
(d) Director of Medical Education, ex-officio;
(e) Director, Indian Systems of Medicine, ex-officio;
(f) Director, Homoeopathy Department, ex-officio;
(g) Director, Public Health Laboratory, ex-officio;
(h) one representative each to be nominated by,--
(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 categorise the clinical establishments and to recommend the Government to prescribe the standards for each category;
(c) compile and publish State Register of Clinical Establishments in such manner as may be prescribed;
(d) appoint panel of assessors for inspection and assessment of the clinical establishments in such manner as may be prescribed;
(e) conduct periodic inspection of clinical establishments for ensuring the standards to be maintained in such manner as may be prescribed;
(f) recommend to the Government any modification required in the rules in accordance with the changes
(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.
(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.
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.
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;
(iii) Director of Health Services;
(iv) Director of Medical Education;
(v) Director of Indian Systems of Medicine;
(vi) Director of Homoeopathy Department;
(vii) Director of Public Health Laboratory;
(viii) one representative of the welfare organisation of patients, nominated by the Government; and
(ix) Secretary of the Council, who shall be the Convenor.
The Executive Committee shall exercise such powers and perform such functions as may be prescribed.
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.
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.
(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.
(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.
(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-officio--Vice-Chairperson;
(c) an, officer not below the rank of Assistant Director of Health and Family Welfare Department nominated by the Government who shall be the Convenor of the Authority;
(d) a Medical Officer of the Indian Systems of Medicine nominated by the Government;
(e) a Medical Officer of Homoeopathic System of Medicine nominated by the Government;
(f) one member whose tenure shall be three years to be nominated by the District Collector from a professional association in the health sector.
(2) Notwithstanding anything contained in sub-sect
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 qualifications fixed by the authorities concerned and advertised by the Council;
(c) undertake to mandatorily comply with the orders issued, by the Council from time to time, in such form as may be prescribed;
(d) undertake to furnish such information to the State Government as notified;
(e) maintain standards of safety, infection control and method of treatments maintaining standards, as may be notified.
(f) such other conditions as may be prescribed.
(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.
(3) All clinical establishments functioning at the commencement of this Act shall be granted provisional registration by the Authority concerned.
(4) All clinical establishments having provisional registration shall acquire the standards for permanent registration in the category within such period as may be prescribed.
(5) All clinical establishments which come into existence after the commencement of this Act shall apply for permanent registration with the Authority within such period as may be prescribed.
(6) Where a clinical establishmen
(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).
(3) The Authority shall, within forty five days of the date of receipt of the application, grant to the applicant a certificate of provisional registration in such form and containing such particulars as may be prescribed and if the registration is not granted or declined within this period it shall be deemed to have been granted.
(4) If it is found that provisional registration granted under sub-section (3) was given not in accordance with law, disciplinary proceedings may be initiated against the officer responsible for granting
Provisional registration shall be valid for a period of two years from the date of issuance of the certificate of registration.
(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 shall apply for permanent registration sixty days prior to the date of expiry of the provisional registration.
(3) The Authority shall, ensure that the details of clinical establishments that have applied for registration are caused to be published, in the manner as may be prescribed, within a period of seven days from the date of receipt of application.
(4) The Authority shall, before granting permanent registration, inspect or cause to be inspected the clinical establishment.
(5) Permanent registration shall b
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.
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.
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.
(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.
(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 application shall be submitted to carry on such clinical establishment:
Provided that in the case of change of ownership, new application for registration shall be submitted within thirty days from the date of change of such ownership and if new registration is not received the functioning of such clinical establishment shall be restrained.
(4) If new services are provided in addition to the services being provided by a clinical establishment, it sh
(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.
it may issue notice to the clinical establishment to show cause why its registration should not be cancelled for the reasons to be mentioned in the notice.
(2) Where the Authority or Council is satisfied, after giving a reasonable opportunity to the clinical establishment to be heard, that there has been a breach of any of the provisions of this Act or the rules made there under, it may, without prejudice to any other action that may be taken against such clinical establishment, by order cancel its registration.
(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 penalty which may extend to fifty thousand rupees and for any subsequent contravention to a monetary penalty which may extend up to five lakh rupees:
Provided if the Council determines, after notice to the establishment and conducting enquiry that the offence is of such serious nature as to attract the provisions of this section, in addition to the penalty, the Council may order th
(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 establishment functions without registration subject to a maximum of five lakh rupees.
(2) For the purpose of adjudging an offence or contravention under sub-section (1), and for imposing any monetary penalty, the Authority shall conduct an inquiry in the prescribed manner after giving the person concerned a reasonable opportunity of being heard.
(3) While holding an inquiry, the Authority shall have power to summon and enforce the attendance of an
(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 which he knows to be false or which he does not believe to be true, shall be liable to a monetary penalty which may extend to one lakh rupees.
(3) For the purpose of adjudging under sub-sections (1) and (2), and for the purpose of imposing any monetary penalty, the Authority shall conduct an inquiry in the prescribed manner after giving any person concerned a reasonable opportuni
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.
(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:
Provided that nothing contained in this sub-section shall render any such person liable to any punishment, if he proves that the contravention was without his knowledge, or that he had exercised all due diligence to prevent such contravention.
(2) Notwithstanding anything contained in sub-section (1), where a contravention of any of the provisions of this Act or of any rule made there under has been committed by a company and it is proved that the contravention has been committed with the consent or connivance of, or is attributable to, any neglect on the p
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.
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.
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.
(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;
(b) Additional Law Secretary, Law Department, (ex-officio)--Member;
(c) Director of Medical Education, (ex-officio)--Member.
(2) Any person, aggrieved by an order of the Authority refusing to grant or renew a certificate of registration or cancelling or revising a certificate of registration or under sub-section (1) of section 27 and sub-section (1) of section 28 and section 29 may prefer an appeal to the Appellate Authority in the manner as may be prescribed within forty five days of such a decision.
(3) Every appeal under sub-section (2) shall be made in such form and be accompanied by
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.
(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 anything contained in this Act, the Council shall have the power to give direction to the Authority to review any decision and proceeding or order passed, including the imposition of penalty, by the Authority under this Act either suo motu or on any complaint and to summon any person concerned or document, in this behalf.
(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 issuing notice to the clinical establishment and giving a right to be represented thereat.
(2) Any officer or assessor carrying out an inspection of any clinical establishment shall file a report, with his findings within 48 hours of the conclusion of inspection, with the Authority authorised for inspection. In case additional information have been sought for he shall file a preliminary report within 48 hours and file the final report within 48 hours after such inform
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.
(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 facilities available, for the information of the patients.
(3) All clinical establishments in the State shall display package rates for specific procedures.
(4) No clinical establishment shall charge fees or package rates more than what is displayed.
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.
(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, cancelled or ceased to function.
(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 Authority or the Council in respect of any loss or damage caused or likely to be caused by 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.
Penalties imposed under this Act and remaining unpaid shall be recovered as if it were an arrear of public revenue due on land.
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.
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).
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.
(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 clinical establishments.
(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 remaining period of the term of the person in whose place he is nominated.
(3) Any member of the Council or Authority may, at any time, by writing under his hand addressed to the Chairperson of the Council or Authority as the case may be, resign his office and he shall be deemed to have resigned his office legally from the date mentioned in the resignation letter, or if date is not mentioned, from the date of acceptance of resignation.
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
(c) has been convicted for an offence which, in the opinion of the Government involves moral turpitude or financial irregularities; or
(d) has been removed or dismissed from the service of the Government or Central Government or a Corporation owned or controlled by the Government or Central Government; or
(e) in the opinion of the Government, has financial or such other interests in the Council or Authority which is likely to affect prejudicially the discharge of his functions as a member.
(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.
(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 be after it is made, be laid before the Legislative Assembly.
(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;
(b) the manner of appointment of panel of assessors for inspection and assessment under clause (d) of sub-section (1) of section 4;
(c) the manner of conducting periodic inspection under clause (e) of sub-section (1) of section 4;
(d) the term of sub-committee appointed under sub-section (2) of section 6;
(e) the powers and functions of the Executive Committee and the manner in which the Executive Committee shall conduct their functions under section 9;
(f) the quorum for a meeting and pr
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