Clinical Establishments (Registration and Regulation) Act 2010

Clinical Establishments (Registration and Regulation) Act 2010

Subject: Polity

Context: The Supreme Court on Tuesday issued notice on a plea which said the Covid-19 spread has “exposed the lacunae in Indian healthcare system” and sought “proper implementation of Clinical Establishments (Registration and Regulation) Act, 2010”.

Concept:

• Article 47 of the Constitution lays down a responsibility upon the State for aiming at improvement in public health and shall consider this responsibility as among its primary duties in particular, the State shall endeavour to bring about prohibition of the consumption except for medicinal purposes of intoxicating drinks and of drugs which are injurious to health.
• The health is a state subject, Article 252(1) of the Constitution permits Parliament to make law on subjects over which it has no power to make laws, “if it appears to the Legislatures of two or more States to be desirable” that there should be a Central law.

Clinical Establishments (Registration and Regulation) Act, 2010

• This Act was enacted after Arunachal Pradesh, Himachal Pradesh, Mizoram and Sikkim agreed to have a central legislation. Other states and UTs could opt to adopt it.
• At present, the Act is applicable in 11 states and six UTs, while 18 states/UTs have their own independent legislation.
• 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 defence forces.
• The registering authority facilitates policy formulation, resource allocation and determines standards of treatment. It can impose fines for non-compliance of the provision of the Act.
• The Act lays down Standard Treatment Guidelines for common disease conditions, for which a core committee of experts has been formed.
• 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.
• 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 establishmed as an independent entity pr 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.

The National Council for Clinical Establishment

The Act lays down establishment for the a Council Body called The National Council for Clinical Establishment which is responsible primarily for setting up standards for ensuring proper healthcare by the clinical establishment and develop the minimum standards and their periodic review.

Patient’s charter

• Union Ministry of Health and Family Welfare (MoHFW), issued a letter to all state governments outlining a smaller set of rights and some additional responsibilities for patients. Some key patients’ rights enunciated in the NHRC charter were dropped in this communication. Nevertheless, this set of do’s and don’ts must be publicised and implemented by all state governments.
• The Act and the Rules provide for registration and regulation of clinical establishments and for matters connected therewith or incidental thereto, namely, to prescribe minimum standards of facilities and services, to ensure affordable and quality healthcare. The Patient Rights’ Charter (notified by the NHRC) affirms and adopts a rights-based health care regime for the patients.
• This Charter of Patient’s Rights is adopted from National Human Rights Commission and international patient charters.
• There is an expectation that this document will act as a guidance document for all empanelled hospitals to formulate concrete mechanisms so that Patient rights are given adequate protection. The Patients’ Rights charter is created to try to reach 3 major goals:
• Assures that the health care system is fair and it works to meet patients’ needs
• To create strong relationship between patients and their health care providers.
• Gives patients a way to address any grievance they may have.
• Patients are informed about the disease, possible outcomes and are involved in the decision making.

Another objective of this Charter is to generate widespread public awareness and educate AB PM-JAY beneficiaries regarding what they should expect from health care providers and what kind of treatment they deserve as patients, in health care settings

Rights Covered

• Right to access medical care
• Right to information
• Right to records and reports
• Right to confidentiality, human dignity and privacy
• Right to second opinion, Patient has the right to a seek a second opinion on medical condition form a doctor or hospital of his/her choice
• Right to safety and quality care according to standards
• Right to proper referral and transfer & continuity of care
• Right to informed consent, Every patient has a right that informed consent must be sought prior to invasive investigation/surgery (e.g. invasive investigation / surgery / chemotherapy
• Right to redress Patient, has the right to give feedback, make comments, or lodge complaints about the health care they are receiving or had received from a doctor or hospital and all complaints must be given a registration number and there should be a robust tracking and tracing mechanism to ascertain the status of the complaint resolution.