The Clinical Establishments (Registration and Regulation) Act, 2010 has been facing a lot of criticism from the medical community for various reasons, some genuine others borne out of resistance to change and fear of regulatory controls. For the benefit of those colleagues, who have not yet read the Clinical Establishments (Registration and Regulation) Act 2010 and Clinical Establishments (Central Govt) Rules, 2012, I shall first bring out the salient points of the Act.
1. The Act was enacted by the Central Govt under Article 252 of the constitution for the states of Arunachal Pradesh, Himachal Pradesh, Mizoram and Sikkim (and also for implementation in the Union Territories). Other states have a choice of implementing this legislation or enacting their own legislation on the subject.
2. The purpose of the Act is to provide for the registration and regulation of clinical establishments with a view to prescribe minimum standards of facilities and services, which may be provided by them.
3. The implementation is to be affected through a three-tier structure — the Central Council, the State Council and the District Registering Authority.
4. The act will be applicable to all clinical establishments (hospitals, maternity homes, nursing homes, dispensaries, clinics, sanatoriums or institutions by whatever name called, that offer services for diagnosis, care or treatment of patients in any recognised system of medicine (Allopathy, Homeopathy, Ayurveda, Unani or Siddha), public or private, except the establishments run by the armed forces.
5. Registration is mandatory for all clinical establishments. No person shall run a clinical establishment unless it is registered and for that the establishment has to fulfil the following conditions:
(a) The maintenance of minimum standards of facilities and services and staff, as prescribed;
(b) Maintenance of records and submission of reports and returns as prescribed;
(c) Undertaking to provide within the staff and facilities available such medical examination and treatment as may be required to stabilise the emergency medical condition of any individual brought to any such establishment;
(d) The clinical establishment will charge the rates for each type of procedures and services within the range of rates determined and issued by the Central Govt in consultation with the State Govt;
(e) The rates charged for each type of service/facility provided shall be displayed in local and English language conspicuously;
(f) The establishment shall ensure compliance of the standard treatment guidelines as may be determined and issued by the Central or the State Govt;
(g) The establishment shall maintain and provide electronic health records (EHR) and electronic medical records (EMR) of every patient as may be prescribed by the Central or the State Govt;
(h) Every establishment shall maintain information and statistics in respect of all other applicable laws and rules, thereunder.
6. Procedure for Registration
(a) The registration will be done by the District Registering Authority (District Health Officer). The Provisional Registration will be issued within ten days of submission of application as prescribed, without any inquiry or inspection. It will be renewable yearly.
The establishments existing before commencement of the Act will have to apply within a year and those started after the commencement of the Act, within six months of the date of their establishment. The registration will be non-transferable.
(b) Provisional registration will not be granted beyond two years from the date of notification of standards in case of establishments that existed before the notification of standards, and beyond six months of notification of standards in case of those established after the notification of standards.
(c) Permanent registration will be granted for a period of five years, on submission of application along with fees and evidence of compliance with prescribed standards. The particulars of the applicant will be published for information of and objections, if any, by the public within 30 days. If objections are received, the same will be communicated to the clinical establishment for a response within 45 days.
(d) Cancellation of Registration (Clause 32). The registration can be cancelled in case of any violation of the conditions or conviction of the manager under the Act, after the issue of a show cause notice. The Registering Authority also has the powers of inquiry and inspection or entry and search of the establishment.
(e) Register of Clinical Establishments (Section 37). The Registering Authority would be required to compile a register of clinical establishments in a digital format within two years and will supply to the state council a digital copy of every entry made in the register. The State Council in turn will provide the details to the Central Council so as to keep the records updated at all times.
7. Offences and Punishments
(a) Running a clinical establishment without registration would be punishable with a fine of Rs 50,000 for the first offence, Rs 2 lakh for the second offence and Rs 5 lakh for the subsequent offence. (Sec 41)
(b) Serving in an unregistered clinical establishment shall be punishable with a fine up to Rs 25,000.
(c) Wilful disobedience of any lawful direction or obstruction to lawful authority or refusal to submit any information asked for or giving false information knowingly, would be punishable with a fine up to Rs 5 lakh. (Sec 42)
(d) In case of a contravention by a company (a hospital) the person in charge of operations/management, shall be liable for action. (Sec 44)
(e) The provisions of Section 44 and punishments would be equally applicable to government departments. (Section 45)
1. The old Acts for registration of hospitals / nursing homes in nine states (mentioned in the Schedule to the Act), make the registration mandatory only for the hospitals and nursing homes (not for the clinics, dispensaries or laboratories) to get registered with the state health authorities. Further, it was applicable only to the Allopathic establishments. Ayurveda, Unani, Siddha or Homeopathy establishments were not covered by them.
The new Central Act is a blanket legislation making it mandatory for all establishments — hospitals, nursing homes, private clinics, laboratories, blood banks, imaging centres etc, of all systems of medicine (including Homeopathy, Ayurveda, Unani, Siddha) public or private, to get registered by a common single Registering Authority called the District Registering Authority.
It, however, exempts the establishments run by the Defence services from registration, for reasons not known.
If some of the states are allowed to continue with their old legislations, then the private clinics / laboratories / imaging centres of all systems and hospitals / dispensaries of non-allopathic systems in those states will not be required to be registered in those states. This will defeat the purpose and will not be a desirable situation.
2. The Central and State Councils include the members from non-allopathic systems also (for dealing with non-allopathic establishments) but representation of non-allopathic systems is not mentioned in the District Registering Authority.
3. Conformity to the Standards: It will take time to lay down the standards for so many different types of establishments pertaining to different systems of medicine.
Meeting the prescribed standards will have cost implications, which is one of the reasons for resistance by private clinics. Fear of inspector raj and undue harassment is another factor.
Monitoring the compliance with standards by hundreds of thousands of establishments will require an army of officials. It will be difficult to ensure implementation of standards, which is known to be our weakest point. We enact beautiful legislations but they remain mostly on paper because we are very poor in enforcement of legislations.
4. Schedule of Charges for Services to be decided by the State: This is a provision, which may not be palatable to the clinical establishments at all. The state cannot and should not dictate the fees for various services/procedures. Even while conforming to the prescribed minimum standards, there may be a lot of difference between the standard of facilities and expertise provided by the establishments, catering to the different locations, clients, standards / tastes / expectations and paying capacity of clients. Every clinical establishment should have the right to determine the charges for the services provided by it. Government should not try to regulate the charges for services.
5. Standard Treatment Guidelines issued by the Central Govt: The standard treatment protocols, in principle, are a good idea as it helps ensure certain basic standards of treatment. But they can be acceptable only as long as they are limited to broad principles, life threatening emergencies (CPR, anaphylactic shock, poisoning, treatment of snake bite etc) or treatment of major public health problems (such as AIDS, malaria, pulmonary tuberculosis). Physicians should have adequate freedom to decide as per their learning and experience, which modality of treatment to use in which situation in broad compliance with the protocols practiced by the professional community nationally and internationally.
6. Maintenance of EHR and EMR of every patient as may be determined and issued by the Central or State Govt. It is a good idea, in principle, but a requirement, which is likely to be resented by the private clinics because of the added cost (of the system, software and the salary of the computer operator) as well as additional workload for busy clinicians. Besides, a large percentage of the physicians, especially those of the ISM (Indian Systems of Medicine), may not be computer savvy at all.
7. Fear of Scrutiny: What is perhaps worrying the physicians more is the fear of scrutiny and exposure of their professional inadequacies, shortcuts, poor facilities, and mistakes as well as the harassment caused by the inspecting officials. So far hundreds of thousands of private clinics, even nursing homes, have been operating all over the country, unknown and hence not subject to any scrutiny / inspection / questioning by anyone. Since they are not known or registered, there is no check over their facilities or standards and many of them go on giving care and treatment of dubious quality, often in utter disregard of the rules and regulations. Their fear is that once registered, they would no more be able to hide from the legal and professional scrutiny.
8. Publishing the particulars of the clinical establishment for public comments / objections / observations, after grant of provisional certificate, does not appear to be a sound idea. It is not clear what purpose will it serve. Firstly, the public will have no clue about the technical aspects / standards of the hospital especially in case of the establishments newly commissioned. Secondly, the local community or the rival establishments are unlikely to come forward with any meaningful comments.
Yes, periodic feedback / comments from public about the quality of services provided by the establishments can be important in case of establishments already registered permanently because their renewal will be due after five long years.
9. Cancellation of Registration (Clause 32): Cancellation of registration in case of private clinics, diagnostic labs, nursing homes etc may be possible but in case of hospitals it may not be a practically feasible idea in view of a large number of patients admitted at different stages of treatment. In case of repeated violations and reckless disregard for the safety of patients, exemplary penalties, to the tune of a yearly profit amount and/or imprisonment for the trustees/CEO/COO (if found negligent), may be more practical.
10. Treatment of Emergency cases — A provision against which many doctors have raised objections has been dealt with in detail in my previous article in ‘AalaTimes’ dated 30 June 2013. Life-saving treatment in the case of life-threatening emergencies has always been and will always remain the prime duty of every doctor, wherever, in whatever position or location. Shirking this responsibility or refusal to render necessary assistance in timely transportation of patient will be viewed as medical negligence liable to punishment.
However, non-payment of medical bills of treatment of emergency cases is a point of serious and genuine concern of the medical community. The Act is silent on this aspect. The authorities concerned must redress the grievance to the satisfaction of medical professionals by putting in place a mechanism of ensuring problem free reimbursement of bills. The liability may be borne by the insurance agencies or by the government itself.
11. Plus Points of the Act:
In spite of the lacunae mentioned above, the Act is a positive development, the need for which was being felt since long. If it is implemented in all the states in the form, broadly in line with the Central Act and Rules,
(a) It would act as the first ever factual census of the number, category, speciality and location of all the physicians and all the medical establishments of all the systems of medicine in the country. That would be a great achievement as it would be a great help in the countrywide planning and posting of physicians as well as healthcare establishments. Up to now the authorities do not know exactly how many of what category are available in which area.
(b) Registration without any inquiry or inspection, on the basis of the documents submitted by the establishment, should be encouraging for many nursing homes / private clinics to come forward and get registered. This may be the biggest plus point of the Act.
(c) It will also help isolate and identify the hundreds of thousands of quacks that are playing havoc with the lives of millions of people all over the country.
(d) Once in place, the system of registration will necessarily help in improving the standards of healthcare establishments within a couple of years. It will also bring about some uniformity in the standards of care across the country.
The Clinical Establishments (Registration and Regulation) Act, 2010 is, perhaps, the most important public health legislation enacted so far with far reaching effects. For maximum benefits and uniform effects, ideally the Central Act should have been made applicable in all the states and union territories. However, being a state subject, that is not possible. Since most of the states would be enacting their own legislations, there will be some variation in the provisions from state to state. But the important aspect is the speed of enactment and enforcement of legislation in the states. There should be no delays on any account. For its successful implementation, it would be prudent that the lacunae are addressed and removed and the legislations made more acceptable to the medical community. It is also expected that the medical professionals rise above the individual interests and think of larger public as well as professional interests.
Dr S K Joshi
MBBS, MD (HA), DNB, QMAHO, MIPHA, MAHA
Hospital Administrator, Assessor for NABH Accreditation
Visiting Faculty: PG Courses for Hospital/Health Management / Quality Management
‘Quality Management in Hospitals’
‘Law and The Practice of Medicine’
‘Safety Management in Hospitals’