The Clinical Establishments Act. There’s hardly a doctor in India who would smile happily upon hearing that term. The more technically accurate name of the act is The Clinical Establishments (Registration and Regulation) Act, 2010. And it has invited severe criticism from many in the medical fraternity, some viewing it as impractical in many ways, making it harder for doctors to practice medicine. Some think that the act which aims to help regulate health care services makes doctors more vulnerable to baseless claims of medical negligence.

So, what exactly are the nitty-gritties of the act which has caused such a furore? Here, we take a closer look.

The reason for the Act

The Act’s key purpose of existence, of course is to help regulate the health care services in the nation. That in itself is a noble intention since it aims to maintain a uniform quality of care across the length and breadth of India. The Central Government enacted the Act with the view of setting the norms for registration of clinical institutions and also prescribe the minimum standards on the facilities and services these institutions provide.

The authority and its functions

The National Council is the authority with the Act. Its functions include facilitating policy formulations, allocating resources and determining treatment standards. As for the district registering authority, it’s functions include registering the medical establishments and also imposing fines for not complying with the provisions mandated by the Act.

The constitutional basis for the Act

Article 47 of the Constitution says that it’s the government’s responsibility to improve public health. It’s the government’s duty too to make sure that intoxicating drinks and drugs which can harm health aren’t consumed unless for medicinal purposes.

So, why a central Act?

One significant question that’s been raised regarding the Act is that when states already have similar acts in place, what’s the relevance of an additional central act. The reasoning that’s being given for this is that health regulation in the country takes into account a whole lot of issues-from disease control to making available proper education to accident prevention to environmental protection and more. This makes it necessary for a central legislation for registering clinical establishments that’s applicable all across the country.

How does the Act define “clinical establishment”?

Essentially all institutions like hospitals, dispensaries, maternity homes, nursing homes, clinic etc. come under the category. In fact, any institution (regardless of the name by which it’s known) that offers services or facilities to diagnose or provide treatment/care for illnesses, injury etc. is also a clinical establishment. It can be an independent entity or part of a larger establishment that is connected to diagnosing/treating diseases. A clinical establishment that’s owned and managed by the government, a government department, a trust, a corporation that’s registered under a Central, Provincial or State Act, a local authority or a single doctor also comes under the definition.

The types of medical establishments that come under the Act

When it’s said that it’s applicable to all clinical establishments, apparently they mean ‘all.’ Whether it be a diagnostic center or a single-doctor clinic functioning under all recognized systems of medicine, it’s mandatory to follow the Act. And yes, it’s equally applicable to institutions in both public and private sectors. The only exception are those establishments that are run by the defense forces.

The Act is meant for controlling the hospitals that are managed by qualified doctors. As for bringing under its ambit those establishments that are managed by un-qualified persons, the IMA has raised the demand to the government to insert one more clause that will prohibit and punish such persons and also shut down operations of such establishments.

The different hospital levels

With relation to the Act, the government has divided hospitals into four levels

Hospital Level 1

This level comprises of establishments in which primary healthcare services are provided by qualified doctors. The services include the likes of General Medicine, Pediatrics, Out patient Services and Obstetrics & Gynecology. The maximum bed strength for these hospitals is 30. Qualified and well-trained manpower who function with the support/supervision of registered medical practitioners and with the support systems required for this level of care is a feature of such hospitals.

Hospital Level 2

Establishments that provide services such as surgery and anesthesia in addition to those provided at level 1 come in this level. These establishments will also have such services as pharmacy, laboratory and diagnostic facility.

Hospital Level 3

Including all services from level 1 and level 2, the establishments in this level can also be multi-specialty clinics with distinct departments. Support systems will include services such as imaging facility and laboratory.

Hospital Level 4

The establishments in this level will provide all the services from level 3. But they will have the distinction of being a teaching/training institute. Not only that, these establishments will also have different super specialties.

Significant things that the Act makes mandatory for the establishments

• Standard Treatment Guidelines for common disease conditions are laid down by the Act. These guidelines are to be followed.
• If someone comes /is brought in to the clinical establishment in an emergency medical condition, the onus is on the establishment to provide the care necessary to stabilize the individual-particularly with women who come in for deliveries and those who suffered accidents.
• As per Section 11 of the Act, no one is to run a clinical establishment if it’s not registered in accordance with the provisions of the Act.
• As per Section 12 of the Act, some of the conditions that an establishment must fulfill for the registration and continuation of a Clinical establishment are the following:

1. Minimum standards of the facilities and the services
2. The minimum requirement of personnel in the establishment
3. Adequate provision for maintaining records and reporting
4. As for hospitals, the minimum standards will be implemented based on the level of care that’s provided by the hospital

States that have adopted the Act

Following the notification dated 29 January, 2010 the Act came into effect in four Indian states-Himachal Pradesh, Arunachal Pradesh, Mizoram and Sikkim. It was also effected in all Union Territories. Later, both Uttar Pradesh and Jharkhand adopted the Act under clause (1) of article 252 of the Indian Constitution.

The procedure for registration of a medical establishment

The Application format for Permanent Registration of Clinical Establishments was issued by the Ministry of Health and Family Welfare in September 2014. Among the information that the applicant is required to provide include the establishment details, services provided and the system of medicine.

When did registration of establishments under the Act begin?

The draft documents for implementing the Clinical Establishments Act was prepared by the National Council for Clinical Establishments in consultation with different stakeholders back in September 2014. The draft documents included:

• The application format for Permanent Registration of Clinical Establishments
• Minimum Standards
• The formats to collect information and statistics
• The template for displaying rates. In this regard, it’s required of the hospitals to follow a particular template to display the different rates for PD, investigation/diagnostic, emergencies etc…
• The standard treatment guidelines of Ayurveda

So, that’s low-down on the Act that has raised concerns from doctors. Whether the various norms etc. put down by it will be revised/amended to make the doctors’ lives a little easier remain to be seen.

Image credits: catchnews

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