Clinical establishment act: Maintaining standard practices

This act is called the clinical establishments (registration and regulation) act(CEA), 2010.

This act aims to achieve the objective set by article 47 of the constitution of India.

Article 47 states that the state has to raise nutrition levels and living standards to improve public health.

So, the state has the primary duty to raise nutrition levels, the standard of living and improve public health. Apart from this, the state shall prohibit the use of alcohol and drugs except for medicinal purposes.

In simple terms, the objective of this act is to regulate clinical establishments in India through an established legal procedure and implement standard practices.

Application Of Clinical Establishment Act

Application to this act gets mentioned in subclause (2) of section 1 of the clinical establishments (registration and regulation) act(CEA), 2010

This act applies to Arunachal Pradesh, Himachal Pradesh, Mizoram, Sikkim and union territories.

It will apply to any other states if those states adopt this act by passing the resolution under clause (1) of Article 252 of the constitution of India.

Clinical establishments

Clinical establishments get defined under section 2(c) of the clinical establishment act 2010.

According to section 2, a clinical establishment means

  • a hospital, maternity home, nursing home, dispensary, clinic, sanatorium or any other name which offers services, facilities requiring diagnosis, treatment for illness, injury, deformity, abnormality or pregnancy by any recognised medical system.
  • It should get administered by any person or any incorporated or unincorporated body of persons
  • a place established referred under the above point, concerning the diagnosis or treatment of diseases where pathological, bacteriological, genetic, radiological, chemical, biological investigations or other diagnostic or investigative services with the help of laboratory or other medical equipment.

These establishments shall be owned, controlled or managed by—

  1. The Government or a Government’s Department;
  2. a trust, whether private or public;
  3. a corporation (including a society) registered under a Central, Provincial or State Act, whether or not Government-owned;
  4. a local authority; and
  5. a single doctor,

An exception to this rule is that it does not include the clinical establishments owned, controlled or managed by the Armed Forces.

Functions Of Clinical Establishment Act

The national council appointed under section 4 of the act has some essential functions laid to perform:-

  1. The council has to compile and publish a national register of clinical establishments within two years from the commencement of the act.
  2. To classify those clinical establishments into different categories
  3. Develop minimum standard practices in these establishments and conduct their reviewing periodically.
  4. Determine the standards’ first set for ensuring proper healthcare by these establishments within two years of commencement of this act
  5. Collect the statistics concerning these establishments
  6. Carry Out any other function as directed by the central government

Section 3 laid provisions for establishing the national council for clinical establishments and details of members and their eligibility criteria.

Section 8 laid provisions for establishing the state council for clinical establishments and details of members and their eligibility criteria.

Section 11 of the act states an obligatory principle for clinical establishment in the territories of its application. It states that no person can run a clinical establishment without duly registering it under the provisions of this act.

While in section 12, conditions for these registrations get prescribed.

For registration of these clinical establishments, there must be some conditions mentioned in this section:-

  1. Minimum standards of services and practices as prescribed.
  2. The minimum number of required personnel
  3. Provisions records and reporting maintenance as prescribed and other conditions as prescribed

Clinical establishments act registration

Any clinical establishment mentioned under this act is eligible to present an application for provisional registration of that clinical establishment under section 14 of the act.

This provisional registration shall get granted within ten days of receiving the application by the appropriate authority.

These provisional certificates shall be valid up to the last day of 12 months from the date of issuing the provisional certificate in the prescribed form, subject to conditions laid in section 23 of this act.

This certificate is non-transferable(section 20).

The application for renewal of these certificates shall be made before 30 days of the expiry date of the provisional certificate. In a case made after that, shall be allowed after paying the required enhanced fees.

There is a time limit to make this application for provisional registration laid under section 23 of this act, beyond which no certificate shall be granted or renewed.

  1. The span of two years from the date of notification of the standards- Clinical establishments came into existence after the outset of the act.
  2. The span of two years from the date of notification of the standards- Clinical establishments came into existence after the outset of the act but before notification of standards.
  3. Period of six months- Clinical establishments came into existence after the notification of standards.

Furthermore, an application for permanent registration of a clinical establishment can get moved under section 24 of the act. The application shall get submitted with evidence of complying with all the required minimum standards.

The appropriate authority if allows the application and grants a certificate of permanent registration, that certificate will be valid for five years(Section 30) and,

If it disallows the application, it shall record the reasons to do so.

The disallowance of the application doesn’t debar the establishment from re-applying for permanent registration after rectifying the deficiencies(Section 31).

An application for renewal of the permanent certificate shall be made to the authorities six months before the expiry of its validity.

Cancellation of the registration can get done anytime after giving show cause notice of three months on the grounds of:-

  1. That the said clinical establishment is not complying with the conditions established and minimum standards
  2. If the person entrusted with the management of the clinic gets convicted of any offence under this act

How to register a clinic in India?

Any person can have clinical establishment online registration through which he can apply for a provisional registration or permanent registration under this act through the online portal of the Ministry of health and the family welfare of the government of India.

The portal incorporates an application form for registration/renewal of registration of clinical establishment.

The online portal called clinicalestablishments.gov.in also provides minimum standards for different categories of clinical establishments act.

Penalty Under Clinical Establishment Act

Section 40 provides that if no penalty is provided in the clinical Establishment Act for any contravention of provisions, the offence is punishable with a fine of ten thousand rupees. For any second, it may extend to fifty thousand rupees and any subsequent offence with a penalty that may extend to 5 lakh rupees.

Section 41 prescribes that if someone carries a clinical establishment without registration,

  • he will get punished with a fine extending to fifty thousand rupees;
  • for the second contravention of this provision, the fine may extend to two lakh rupees, and
  • on subsequent contravention, this fine rises to five lakh rupees, and
  • whoever knowingly serves in that non-registered establishment shall be punished with a fine extending to twenty-five thousand rupees.

According to section 42, whoever in his own volition disobeys any direction given by any person or authority empowered to do so under this act or obstructs that person or authority from doing the same shall be punished with a fine extending to five lakh rupees.

Any person required under this act to supply any information, withholds such information or provides false information knowingly shall be liable to a monetary penalty extending to five lakh rupees.

Further, section 43 covers penalties for minor deficiencies,

Section 44 covers penalty for contravention of provisions under this act committed by companies,

Section 45 covers penalties for offences by government departments,

Section 46 prescribes a provision for the recovery of fines.

Evolution of clinical establishment act till date

Initially, this act has taken effect in four states, namely, Arunachal Pradesh, Himachal Pradesh, Mizoram, Sikkim, and all union territories except the NCT of Delhi.

Uttar Pradesh, Uttarakhand, Rajasthan, Bihar, Jharkhand, Assam and Haryana have adopted the Act under clause (1) of Article 252 of the Constitution.

With the development of the Jammu and Kashmir(J&k) reorganisation act, 2019, Jammu and Kashmir got reconstituted as a union territory.

So as per section 1(1) of the CEA, 2010, it applies to J&K, as it is a union territory now.

The state of Karnataka came with its own Karnataka medical establishments act in 2007 even before the CEA.

After that the state of West Bengal came with its own West Bengal clinical establishment ( Registration, regulation and transparency) Act, 2017. This act is only applicable to hospitals with over 100 beds.

Case study Involving Clinical Establishment Act

Ahmad Nabi v. State of Uttarkhand & Ors.

Does the state have a duty to check that all clinical establishments are registered or not and keep a check on those who are not duly registered?

AND

Whether these clinical establishments are complying with the minimum standards?

In the case of Ahmad Nabi v. State of Uttarkhand & Ors. Writ Petition (PIL) NO.120 OF 2016 observed that “once any legislative enactment is made, it is the duty of the State to implement and carry it out in letter and spirit.

It also observed that article 47 lays down an obligation on the states to maintain a public health standard by strictly applying the statutes to regulate their functioning.

It is the state’s primary duty to maintain these public health facilities as every citizen has a right to life under article 21 of the constitution of India.

The Uttarakhand high court issued a few mandatory directions:-

  1. The Court stated that it is the state’s responsibility to shut down all those public health facilities if not registered as required under the Clinical Establishments (Registration and Regulation) Act, 2010.
  2. The state government must ensure that all the running public health facilities registered under the 2010 Act follow the Operational guidelines as per this act.
  3. The court had also observed that many hospitals and clinics often make their patients go through unnecessary diagnostic tests.

    Thus, the court directed that clinical establishments throughout Uttarakhand don’t put patients through unnecessary diagnostic tests. Only the tests required to diagnose the actual medical condition of the patient are permitted.

  4. Patients shouldn’t get forced to buy expensive medicine when generally available medicines have the same effect. Thus, doctors practising across Uttarakhand (including government doctors) are required to prescribe only generic medicines.
  5. The state must set the various diagnostic tests or procedures conducted on patients by various clinical establishments.
  6. The outer wall of Intensive Care Units (one of its sides) shall have transparent glass having cloth curtains. It would enable the attendants of the patient to see the patient. The patient’s attendants shall be informed about the health or condition of the patient after every 12 hours.

Kothari medical centre v Smt Anjali Moitra

Is a hospital liable for the negligent acts of its staff under the rule of vicarious liability?

In the case of Kothari medical centre v. Smt Anjali Moitra state, the consumer redressal commission found the Kothari medical centre liable for the negligent act of its staff while administering hot water bags and causing blisters. It is the liability of the hospital for the commissions of omissions on the part of their staff.

Conclusion

It is conclusive that the present act gets codified to establish a medical system with better medical standards.

The state has to bring all the public health facilities under the ambit of the CEA, 2010. Our medical sector complies with the rules set up for them and provides better facilities without any arbitrary move.

The government’s objective is that by this act, these public health facilities run their work under the government’s vigilance by duly registering themselves and without exploiting the country’s people.

This act enables the state to check the personnel involved with medical facilities and on their conduct.

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