Kerala Clinical Establishments (Registration and Regulation) Act 2018
Frequently Asked Questions

What is the Kerala Clinical Establishments (Registration & Regulation) Act 2018? 
    The Kerala Clinical Establishments (Registration and Regulation) Act 2018 is a proposed legislation that provides for registration and regulation of clinical establishments in Kerala.

What is the Objective of the Act? 
    The objective of the Act is the improvement of public health by prescribing basic minimum standards for different categories of clinical establishments to ensure the provision of proper quality healthcare by the clinical establishments. The Act will also help to collect the required data and statistics from clinical establishments for better policy formulations, planning, implementation, response and evaluation. 

What does ‘clinical establishment’ mean? 
    A clinical establishment means


(i) a hospital, maternity home, nursing home, 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, infertility or pregnancy in any recognized 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 investigation or other diagnostic 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,

Who is covered under this Act? 
    All clinical establishments across all recognized systems of medicine (i.e. Modern Medicine (including Dentistry), Ayurveda, Naturopathy, Homoeopathy, Siddha, and Unani) in the public and private sectors are covered under this Act. This includes, all establishments owned, controlled or managed by the Government, a Department of the government, a trust (public or private), individual proprietorship, a partnership firm, corporation registered under a Central, Provincial or State Act (whether or not owned by the Government), a local authority. 

Are there any clinical establishments that are not covered under the purview of the Act? 
    The clinical establishments owned, controlled or managed by the Armed Forces and clinical establishments offering only consultation services are not covered under this Act. 

What are the salient features of the Act? 
(a) Assists in generation of reliable and comprehensive database of all types of clinical establishments in the state and in the country.  
(b) Helps classify various types of clinical establishments into categories & determine category wise basic minimum standards. 
(c) Defines basic minimum standards using participatory and consultative approach to ensure uniformity across all establishments.
(d)  Assists Government in obtaining information and data required from Clinical Establishments for public health interventions including outbreak and disaster management. 
(e) It establishes the multi-stakeholder bodies at State and District level. 
(f) Establishments of District Registration Authority at each district. 
(g) The Act allows for two-step process of registration – provisional and permanent registration. Provisional registration is done through a process of self-declaration, without any inquiry or inspection. Permanent registration would be undertaken after categorization, classification and notification of category wise minimum standards. 
(h) The Act places the entire process of registration and the data of clinical establishments in the public domain which ensures transparency.
(i) Details of charges, package rates, facilities available would be prominently displayed at a conspicuous place at each establishment.
(j) Registry of clinical establishments would aid in policy formulation and resource allocation. 
(k) Cancellation of registration would occur at any time, if conditions for registration are not complied with. 
(l) It lays down provisions for healthcare providers to maintain records and reporting as prescribed.

What is the composition of the State Council for Clinical Establishments? 
    It is a multi member body under the Secretary to the Government, Health and Family Welfare Department. An officer not below the rank of Deputy Director of Health Services, Dept. of Health and Family Welfare of will be the Secretary of the Council. The State Council has members from regulatory councils for Modern medicine (MCI)  Nursing, Indian Systems of Medicine (Ayurveda, Siddha and Unani), Homoeopathy and a representative from patient welfare organization. The detailed composition of State Council for Clinical Establishments may be seen in the Act.

What are the functions of the State Council for Clinical Establishments? 
    The State Council shall: 


(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 establishment;
(b) Classify and categorize the clinical establishments and determine the minimum standards for each category and recommend to the Government for approval and notification.  
(c) Compile and publish a State Register of Clinical Establishments in such manner as may be prescribed;
(d) Appoint a 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 in technology or social conditions;
(g) Notify data and information which are to be mandatorily provided by Clinical Establishments including their periodicity; analyze the data and make results available in  the public domain in such manner as may be prescribed; 
(h) Send periodic returns for updating the National Register as required by the Central Government or the National Council constituted under the Clinical Establishments (Registration and Regulation) Act, 2010 (Central Act 23 of 2010);
(i) Direct the cancellation of registration of such clinical establishments where there is imminent danger to public health and the health and safety of patients and staff; and.
(j) Perform such other functions as may be assigned to it by the Government from time to time.

Who is responsible for registering a clinical establishment under this Act? 
    The owner of the clinical establishment is responsible for registering the clinical establishments under this Act. 

Who is the registering authority? 
    A multi member authority at district level known as the District Registering Authority is the registering authority for Clinical Establishments located in that district. 

What is the composition of the District Registering Authority? 
    The district registering authority will comprise of 
(a) District Collector, ex-officio- Chairperson; 
(b) District Medical Officer, ex-officio-Vice-Chairperson; 
(c) A Medical Officer of the District Medical Office nominated by the Government, who shall be the Convener
(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 nominated by the District Collector from a professional association in the health sector.   

What are the functions of the district registering authority? 
(a) Grant, renew, suspend or cancel registration of a clinical establishment; 
(b) Enforce compliance of the provisions of the Act and the rules made thereunder;
(c) Cancel the registration of such clinical establishment where there is imminent danger to public health and the health and safety of patients and staff;
(d) Prepare and submit reports periodically of such nature as directed by the Council; 
(e) Perform   such other functions as may be prescribed.

Will the same minimum standards apply to all clinical establishments? 
    No. 
    Clinical establishments will be classified into different categories. This would be based on the size (number of beds), services and facilities provided. There would be different minimum standards prescribed for different categories. Smaller hospitals and nursing homes would have different standards from the bigger hospitals.  

In case of grievances, who can be contacted? 
    Under the Act there is a grievance redressal mechanisms being set up to received complaints from the public regarding the violation of the provisions of this Act or the rules by any clinical establishment.

What are the institutional mechanisms set up under this Act? 
    State Council 
    District Registering Authority 
    Executive Committee
    Appellate authority
    Grievance redressal

What are the conditions for registration of a clinical establishment under this Act? 
(a) The minimum standards according to the category of clinical establishment as may be notified by government.
(b) the medical and paramedical staff shall have the minimum qualifications as may be notified by the concerned authority and  published by the State 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 standard treatment guidelines as may be notified by the Government 
(f) Such other conditions as may be prescribed.


Other conditions are: 
(i)  Display the Registration certificate at a prominent place. 
(ii)  Display the rates charged for each type of service provided and facilities available, package rates for the benefit of patient at a conspicuous place.  
(iii)  Maintain and provide information and statistics in accordance with all other applicable laws that are in force and rules made thereunder.

Is the clinical establishment required to display the certificate of registration? 
    Yes, the certificate should be displayed at a prominent place from where it is clearly visible. 

    If my clinical establishment is shifted to another location in the same district, then what is the procedure to be followed? 
In event of change of major or broad location, or on ceasing to function as a clinical Establishment, the certificate in respect of such clinical establishment shall be surrendered to the Authority and the Clinical Establishment shall apply afresh for registration. 

   
If I move my facility to some other district, what is the procedure to be followed? 
    In event of change of location the certificate in respect of such clinical establishment shall be surrendered to the Authority and Clinical Establishment shall apply afresh for registration. 

I am accredited by NABH. Do I still need registration? 
    You need to register but there will not be any assessment by the DRA.

What is the procedure for registration? 
   The registration can be done through online by visiting website www.keralaclinicalestablishments.gov.in. 

What is provisional registration? 
    There are two types of registration — provisional and permanent. Provisional registration would be provided on submission of the application and would be granted. Provisional Registration would be granted within 45 days of application being filed. 

What is Permanent registration? 
    Once minimum standards have been notified by the Government  for the Clinical Establishments, Permanent registration would be provided to all those conforming to the notified minimum standards prescribed for that category of clinical establishments. 

Who will issue the registration certificate? 
    The District Registering Authority shall issue the registration certificate.

Will there be inspection before I am granted a provisional registration certificate? 
    For purpose of provisional registration there will not be any inspection prior to grant of registration. However the owner of clinical establishment is expected provide and to fill in all data correctly & provide the documents requested for. 

Once I receive a provisional certificate of registration, what is the validity? 
    Every provisional registration shall be valid for two years from the date of issue of the certificate of registration. 

When will permanent registration be undertaken? 
    Permanent registration will commence after minimum standards are notified. 

Is there a penalty for not registering a clinical establishment under this Act? 
    No one can run a clinical establishment without registration. Yes, monetary penalty would be imposed and in certain cases closure of the establishment. (Kindly see the Act for more details)