Clinical Establishment Act & Rules PPT PDF

What is Clinical Establishment Act & Rules?

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 recognized system of medicine established and administered or maintained by any person or body of persons, whether incorporated or not;

or

a place established as an independent entity or part of an establishment, in connection with the diagnosis or treatment of diseases where pathological, bacteriological, genetic, radiological, chemical, biological investigations 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, whether incorporated or not, and shall include a clinical establishment owned, controlled or managed by the Government or a department of the Government; a trust, whether public or private; a corporation (including a society) registered under a Central, Provincial or State Act, whether or not owned by the Government; a local authority; and a single doctor,

Clinical Establishment Act & Rules

The Clinical Establishments (Registration and Regulation) Act, was passed by Parliament in 17th August 2010.

The act has been enacted by the Central Government to provide for prescribe and regulation of all clinical establishments in the country with a view to describe the minimum standards of facilities and services provided by them.

The Act has taken effect in the four States namely, Arunachal Pradesh, Himachal Pradesh, Mizoram, and all Union Territories except the NCT of Delhi since 1st March, 2012

Clinical Establishments Act aims to register and regulate clinical establishments based on minimum standards in order to improve quality of public health care in the country.

Objectives

The specific objectives are

1.To establish digital registry of Clinical Establishments at National, State and District level.

2.To prevent quackery by unqualified practitioners by introducing registration  system, which is mandatory.

3.To improve quality of health care through standardization of healthcare facilities by prescribing minimum standards of facilities and services for all categories of health care establishments (except teaching hospitals,) and ensuring compliance of other conditions of registration.

Salient features & benefits of the CEA 2010

1.All clinical establishments – including diagnostic centres and single doctor clinics,

2.across all recognized systems of medicine in both public and private sector. (exception: establishments of the Armed Forces) are. covered.

3.The Act shall assist in compilation of reliable digital registry of all types of clinical establishments at National, State and District level available in public domain.

4.Standard application form for registration of clinical establishments to ensure uniformity in information being collected.

5.Assist government in obtaining information and data required from clinical establishments for public health interventions including outbreak and disaster management

•6.Provisional registration, through a process of self-declaration, without any inspection.

7.Permanent registration would be undertaken after categorization, classification and development of minimum standards

8.Application for registration by post, in person or online

9.Mandatory for every clinical establishment to provide treatment to stabilize the emergency medical condition of any individual brought to such establishment.

10.Establishment of multi stakeholder institutional bodies.

Also Read: Drugs and Magic Remedies Act 1954

Conditions for grant of registration

For registration and continuation, every Clinical Establishment should fulfill the following prescribed conditions,

1.The minimum standards of facilities and services

2.The minimum requirement of personnel

3.Provisions for maintenance of records and reporting

4.Undertaking to provide with the staff and facilities available, required medical examination and treatment to any patient/individual who comes or is brought to such clinical establishment.

5.such other conditions as may be prescribed under the rules such as

–Prominent display of details of facilities available and rates charged in local and in English language

–Maintenance Electronic medical records or Electronic Health records of every patient as required by Central/State Govt.

–Assurance of compliance to Standard Treatment guidelines issued by Central/State Govt.

–Maintenance of information and statistics in accordance with all applicable laws and rules.

–Charging the rates for facilities and services within the range of rates declared by the Central Government from time to time in consultation with the State Governments.

The minimum standards for hospitals are implemented based on the level of care provided by such hospitals. Services and/or care provided at specialty and super specialty or multi-specialty allopathic hospitals decide the level of hospital

•Hospital Level 1 a

•Hospital Level 1 b

•Hospital Level 2

•Hospital Level 3 (Non teaching)

•Hospital Level 4 (Teaching)

Procedure for registration of the clinical establishment

•No person shall run a clinical establishment unless it has been duly registered in accordance with the provisions of the Act.

•In September 2014, the Government of India, the Ministry of Health and Family Welfare issued the Application format for Permanent Registration of Clinical Establishments which requires the applicant to provide information such as, establishment details, types of service, system of medicine, etc.

•There are two types of registrations (a) Provisional Registration and (b) Permanent Registration.

•Application in prescribed format can be submitted in person, or by post or online along with necessary fee to District Registering Authority.

Provisional Registration

•For provisional registration, the authority without conducting inspection or enquiry, grant a certificate of provisional registration with in a period of ten days from the date of receipt of application.

•Provisional registration is valid up to the last day days twelth month from the date of issue which is renewable.

•The application for renewal is to be made within thirty days before the expiry date.

Permanent Registration

•For permanent registration, the clinical establishment must  apply along with the proof that it has complied with the prescribed minimum standards.

•The  authority may conduct the inspection or make any enquiry of applicant clinical establishment.

•Details regarding the compliance with standards and conditions of registration by clinical establishments are to be displayed for the information of public.

•The public can take objection if the information is not authentic.

•After satisfying the authenticity the registering authority may grant the certificate of registration.

•Permanent registration is valid for a period of five years from the date of issue of the certificate of registration.

Penalties under the Act

Only fine of 10000 to 5 lakh depending on type and severity of offence. No imprisonment is prescribed under this Act.

Clinical Establishment Act & Rules PPT PDF