why the health care services have to be regulated?
to maintain the uniform quality care throughout the country.
what the govt has done to achieve this objective?
The Clinical Establishments (Registration and Regulation) Act, 2010 ("Act") has been enacted by the Central Government to provide for registration and regulation of all clinical establishments in the country with a view to prescribing the minimum standards of facilities and services provided by them.
is it enough to regulate only the hospitals?
No. Health regulation means not only the hospitals but also it should cover various wings.
Health is in concurrent list. so state govts also have the right and responsibility. when states have this type of act, what is the need for the central act?
As we all know, health regulation in India encompasses a variety of factors and issues. These include promulgation of legislation for health facilities & services, disease control & medical care, human power (Education, Licensing & Professional Responsibility), Ethics and Patients Rights, Pharmaceuticals & Medical Devices, Radiation Protection, Poisons & Hazardous Substances, Occupational Health and Accident Prevention, Elderly, Disabled & Rehabilitation Family, Women and child Health, Mental Health, Smoking/Tobacco Control, Social Security & Health Insurance, Environmental Protection, Nutrition.
Hence, there is a need for a central legislation for registration of clinical establishments in the country and uniform standards need to be developed for the entire country.
what type of Medical establishments are in the ambit of this CE act?
The Act makes it mandatory for registration of all clinical establishments, including diagnostic centres and single-doctor clinics across all recognized systems of medicine both in the public and private sector except those run by the defense forces.
who is the authority?
national council.
what are the functions of national council?
It facilitates policy formulation, resource allocation and determines standards of treatment.
what are the functions of the district registering authority?
It can Register the medical establishments and can impose fines for non-compliance of the provision of the Act.
what are the things , that the act imposing on establishments?
- The Act lays down Standard Treatment Guidelines for common disease conditions.
- Further, the Act makes all clinical establishments to provide medical care and treatment necessary to stabilize any individual who comes or is brought to the clinical establishment in an emergency medical condition, particularly women who come for deliveries and accident cases.
yes. Vide the notification dated 28 January, 2010 the Act came into force in four states of India, namely Arunachal Pradesh, Himachal Pradesh, Mizoram, Sikkim and all Union Territories.
Are any other states adapted his act?
yes. Uttar Pradesh, Rajasthan and Jharkhand have adopted the Act under clause (1) of article 252 of the Constitution.
Are there any state acts to regulate the medical establishments?
yes. in andhrapradesh ,Maharashtra and the Kerala .
What the constitution says? is there any constitutional basis for this act?
as per Article 47 of the Constitution improving the public health is the responsibility of the govt. and its also the duty of the govt to prohibit the consumption except for medicinal purposes of intoxicating drinks(alcohol) and of drugs which are injurious to health.
what is meant by clinical establishment?
The Act defines "Clinical Establishment" and bring under the ambit of clinical establishment all hospitals, maternity home, nursing home, dispensary, clinic, etc or an institution by whatever name called that offers services, facilities requiring diagnosis, treatment or care for illness, injury, etc or a place establishment as an independent entity or part of an establishment in connection with the diagnosis or treatment of certain diseases. It also includes a clinical establishment which is owned, controlled and managed by government or a department of the Government, a trust, a corporation registered under a Central, Provincial or State Act, a local authority and a single doctor.
is this act limited only to control the hospitals managed by the qualified doctors?
yes. Section 11 of the Act mandates that no person shall run a clinical establishment unless it has been duly registered in accordance with the provisions of the Act.
But what about those establishments managed by un-qualified persons? you know as per the recent WHO report, among the thousands of medical establishments in our country ,only 36% have been managed by qualified doctors. the remaining 64% of the establishments are managed by un-qualified personnel. how the govt address this challenge?
Thatswhy IMA demands the govt to insert one clause to prohibit and punish the unqualified personnel and close those establishments.
what is the procedure for registration of medical establishment?
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, among others, establishment details, types of service, system of medicine, etc.
what are the core clauses of this act?
Section 12 of the Act lays down that for the registration and continuation of a Clinical Establishment, such clinical establishment shall fulfill the conditions namely,
- the minimum standards of facilities and services
- the minimum requirement of personnel
- provisions for maintenance of records and reporting
- such other conditions as may be prescribed.
what is the main criteria for laying of minimum standards?
The minimum standards for hospitals are implemented on the basis of level of care provided by such hospitals.
since when the govt started the registration of the establishments.?
In September 2014, the National Council for Clinical Establishments under the Chairmanship of Director General of Health Services, Government of India in consultation with various stakeholders has prepared following draft Documents with the objective of implementation of the Clinical Establishments Act:
- Application format for Permanent Registration of Clinical Establishments
- Minimum Standards
- Formats for Collection of information and Statistics
- Template for Display of Rates:The Hospitals are required to follow a particular template for display of the various rates related to PD, Investigation /diagnostic, emergencies, etc...
- Standard Treatment Guidelines of Ayurveda Accordingly, the draft document issued by the Government this September4 divided hospitals into 4 levels of hospitals, namely -
Hospital Level 1-Primary medical services.
Hospital Level 1 are the primary healthcare services provided by qualified doctors. It includes services such as General Medicine, Pediatrics, First aid to emergency patient and Out Patient Services, Obstetrics & Gynecology Non-surgical and Minor Surgery and have a bed strength of not more than 30 which can be provided through trained and qualified manpower with support/supervision of registered medical practitioners with the required support systems for this level of care.
Hospital Level 2- secondary care and surgical services.
This level includes services of Surgery and Anesthesia in addition to the services provided at level 1 through registered medical practitioner under supervision and with support of specialists. It will also have other support systems required for these services like pharmacy, laboratory, diagnostic facility, etc.
Hospital Level 3- tertiary care.
This level includes all the services provided at level 1 and 2 and in addition the following as well such as Multi-specialty clinical care with distinct departments, General Dentistry, Intensive Care Unit,. Tertiary healthcare services can be provided through specialists. It will also have other support systems required for these services like pharmacy, Laboratory, and Imaging facility.
Hospital Level 4 – teaching institutions.
This level will include all the services provided at level 3. It will however have the distinction of being teaching/ training institution and it will have multiple superspecialties. Tertiary healthcare services that can be provided through specialists. It shall have other support systems required for these services. It shall also include the requirements of MCI/other registering body.
comments by HBI-IMA AP:
1.why the National Council for Clinical Establishments under the Chairmanship of Director General of Health Services, Government of India,is silent on establishments managed by un-qualified personnel?
2. why the National Council for Clinical Establishments under the Chairmanship of Director General of Health Services, forgot the national law commission's report-2006,stating that services delivered by clinical establishments to emergency critical patients have to be paid by the govt,by establishing suitable mechanism.
3. quackery is a known menace in our country. abuse of the antibiotics and steroid drugs is on the rampage,which is due to quacks.why the the National Council for Clinical Establishments under the Chairmanship of Director General of Health Services, is silent on this grave concern?
4. as per Article 47 of the Constitution,the govt has the responsibility of prohibiting the alcohol,smoking.
why the National Council for Clinical Establishments under the Chairmanship of Director General of Health Services, is averse to implement the Article 47 of the Constitution ?
DR.C. SRINIVASA RAJU
Chairman - Hospital Board of India - IMA AP STATE.
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