OPINIONS

Clinical Establishments Act, 2010: Salient Features & Critical Analysis

Wednesday, July 10, 2013

by Dr S K Joshi

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.

Salient Features:

Dr S K Joshi

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)

Critical Analysis

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
Author:
‘Quality Management in Hospitals’
‘Law and The Practice of Medicine’
‘Safety Management in Hospitals’

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14 Comments »

Comment by Arin
2013-07-11 18:53:29

One thing is not clear to me. Does this act mandate the registration of “chambers” of doctors? If so, does it mean, that every private practitioner’s “chamber” would have to be equipped with drugs and equipments to render emergency services? How on earth is that feasible?

 
Comment by Dr S K Joshi
2013-07-11 20:06:03

Thank you Dr Ritambhara Mehta for your appreciation.

Dear Dr Arin,

It depends on what exactly is your concept of a chamber. If it is a chamber in a hospital/nursing home/or polyclinic, then the arrangement for emergency treatment would be of the entire establishment. Every chamber is not expected to have a separate arrangement for emergencies.
If on the other hand, by Chamber you mean a stand- alone clinic where you provide only consultation and do not dispense drugs or carry out any procedures, then you are not expected to have the arrangement for emergency treatment. But I don’t think there would be any ( stand alone ) consultant who would not have at least the basic emergency drugs tray and IV fluids to take care of emergencies that can always occur even at the consultation chamber.

The important point to note is that law expects the doctor to provide whatever best help, clinical or general, that the doctor can provide under the circumstances to save the life of the patient. The Act clearly states –“ within the staff and facilities available”. A hospital or nursing home that generally accepts emergencies, if does not provide emergency treatment to the patient ( in spite of having the facilities ) would be violating the law. On the other hand, a stand-alone consultation chamber ( which does not normally cater to the emergencies is not expected to have all the life saving treatment. If the consultant can provide the patient even the basic life saving measures whatever expected at a stand-alone consultation chamber and help the patient in transportation to the nearest hospital, he has done his job. Law does not expect any clinic or chamber to acquire the emergency facilities or ambulance( which it otherwise does not require for its specialty or clientele) in anticipation of receiving emergencies.
I hope I have answered your question. If not , you are welcome to get in touch at skjoshi1948@yahoo.com

Dr S K Joshi

 
Comment by Arin
2013-07-12 00:14:02

Respected Dr S K Joshi,

Thankyou for your kind explanation. I understand now.

Arin

 
Comment by Dr Neeraj Nagpal
2013-07-12 13:53:24

What is forgotten in this loud applause for CEA is the fact that
1) It leaves no option of limited medical practice. A doctor for reason of seniority, health or out of choice can no longer provide consultancy for few hrs from a portion of his residence unless and until he is willing to provide emergency services of all specialities round the clock (since he stays in the establishment)
2) Home visit, medical camps in village schools not being clinical establishments registered under the act and hence no home visit or medical camps would be possible.
3) Never will unregistered quacks be effected by CEA. It is only those centres registered under CEA which will be repeatedly harrassed by Inspector sahib (PCPNDT Act is a coase to point)

 
Comment by Dr. PS Kapoor
2013-08-02 22:15:04

CEA is silent about the fate of senior, retired, over-aged doctors, providing just consultancy of their respective speciality, benefitting their respective needy patients of their expert advice (diagnosis as well as required treatment), irrespective of few patients attending their clinics, being run from a part of their residence, already paying the unjustified commercial water & electricity charges for the whole residencial premesis, property tax, pollution tax for non-generating pollution (only consultation) for their fault of attending to few patients (even less than 300 PM). It is irrational to overburden these senior doctors (mostly suffering from age disorders, to attend to patients of all specialites esp. at odd hrs. thereby aggravating their own ailments. Besides maintaining trained staff (cost factor) is also overburden.
Author : Medical Jurisprudence

 
Comment by dr Yudhvir singh
2015-04-16 21:22:32

Sir
There is too much grey area in medical field but due legal litigations this grey area should be ended. For example (1) who can put ICD . MBBS/MS surg/ MCH CTVS ect. It is life saving procedure if a MBBS doctor do and pt. Could not be saved than he can be sue that he should transfer the pt.
In other condition; if he tries to transfer and pt expire on way. Then he can be sue that emergency life saving procedure should have been done.
(2) MI pt. Till what level treatment should be provided by MBBS MD DM. If there is requirement of transfer ; how can one contact higher centre or acl ambulance in Indian condition.specially in government system it second to impossible to provide above.
So there must be clear guide line without any grey area as nows days doctors are being punished for any file case. All procedures should be clarified that who can do without condition of patients otherwise doctor have to prove that it was emergency so he did and case applicants will prove there was time to transfer.
Kindly look and considerate as at last doctors are also human being.they are also have families.
Thanking you.

 
Comment by Dr. Raman Arora
2015-04-24 19:17:38

Dear Sir,
Regards,

Please view http://clinicalestablishments.nic.in/WriteReadData/292.pdf, whose Page No. 6 defines Allopathic Hospital as under :

“1. Definition
A hospital is a clinical establishment providing patient treatment by qualified and trained staff and equipment through Allopathy – Modern system of medicine; where the patients are ‘admitted’ and stay overnight or more and they are referred as ‘inpatients’; while some patients may go to a hospital just for diagnosis, treatment, or therapy and then leave, they are referred as ‘outpatients’ without staying overnight. In a hospital, treatment by staff from AYUSH may also be provided.”

Please note that provision of treatment by AYUSH staff mentioned here is not for AYUSH establishment, but it is for Allopathic Establishment. This will be obvious on clicking other Allopathic Clinical Establishments also e.g. ‘Hospital Level 2′ (http://clinicalestablishments.nic.in/WriteReadData/885.pdf, page 6), and ‘Hospital Level 3′ (http://clinicalestablishments.nic.in/WriteReadData/776.pdf, page 6).
This will lead to legalisation of the quackery of cross-pathy type.

Please view http://clinicalestablishments.nic.in/WriteReadData/847.pdf, whose Question No. 11 (and its answer), on pages 5 and 6 reads as under :
“11.What is the composition of the District Registering Authority?
The district registering authority will comprise of District Collector as chairperson, District Health Officer / Chief Medical Officer as convener and three other members nominated by the District Collector/District Magistrate.
The three nominated members shall include,
a) A senior level officer of the local self-Government at the district level,
b) One representative from a professional medical association or body having presence, preferably within the district or within the State like IMA or AYUSH.
c) City Police Commissioner or Senior Superintendent of Police (or his nominee), whose help is required if the particular Clinical Establishment does not cooperate with the district registering authority and refuses to give permission to the teams visiting his or her clinical establishment’s premises.”
Please note that if the professional representative member happens to be from AYUSH instead of IMA, it will be not be justified for AYUSH member controlling MBBS doctors.

Please give your comments and the possible measures for solution.
Thanks

Dr. Raman Arora
MBBS
Mob. 09855525282

 
Comment by Dr.himanshu
2015-08-03 23:20:31

As per CEA its mandatory for all establishment to get register, including small clinics. If not registered then you cannot operate your clinic or establishment, indirectly you can not practice medicine until unless you are registered under CEA. My question is then why to get register in MCI ?. What is the use of multiple body registration for single profession. CA don’t have to do that, lawyers don’t have to do that then why doctors.
Was is it really so necessary to have police man in registration body. Are doctors in india criminals ?
Already running the nursing home requires apprx 150 licenses from local bodies.
What about shortage of paramedical staff. Even govt hospitals are facing it. What will be the status of CEA registration in case establishment is under staff.
Why defense hospital not covered under CEA. Are they not part of this country?
AYUSH and Allopath both have there respective medical councils. Before practicing medicine they have to register with there respective councils. No quak is eligible for registration but still practices. Lets see how efficiently how CEA will check quakry.
In india we have basic problem all the laws are meant for those who sincerely abide by them, not for those who don’t follow them.

 
Comment by Prashant tanna
2015-10-31 14:37:52

It’s organising road side low cost vendors to shops. From next door shops to shopping centres. Its not odd or unpracticle but harshness of punishment with interference of legal authority is unrealistic. If government set up will not be able to fulfill criteria will they shut down the phc/chc? If doctors are not allowed to practice / shut clinics = what will they do?

 
Comment by sanjay jaiswal
2016-03-03 23:19:22

Sir, as per the Act, other states have a choice of implementing this legislation or enacting their own legislation on the subject. Does it mean that a State Govt.shall either implement the Act or enact its own rules over the Act.
If so, then why Gujarat Govt has not implemented this act or enact its own legislation on the subject. Shall it not be mandatory for all the State Govt to have either of choices within a particular period.

 
Comment by Major Prakash Patil (Retd)
2016-07-11 21:19:49

Dear Dr Joshi ji,
Thanks for introducing readers to CEA. I am a non-medico and I was not aware of the existence of this Act. But even most medicos too are not aware of this Act. Many are not aware of even previous Acts like Bombay Nursing Home Act, applicable in Maharashtra. Many medicos (including Allopathic) are practicing nonchalantly, without any registration as per existing State Acts. The infrastructure and services are quite substandard in many hospitals.
It would be a welcome step, if all states are asked to pass the similar Acts at state level, while ensuring that previous Acts of similar nature are nullified.
The Act certainly has some lacunae, but they can be reviewed after an year or so after the implementation. Raising hypothetical and rare situations by medical fraternity is not correct. However, I too feel that a police officer should not be a member of the district registering authority.
Moreover, collector is too busy to do justice to this job. Instead a retired district judge should preside over the registration authority. It should be full fledged and salaried job for him
Some doctors have raised the question of practicality of implementing CEA provisions in such a huge country. I feel, had MCI and state councils done their job properly during last seven decades, the problems would not have arisen. These councils, the members of which have been elected by the very doctors, who are to be disciplined, have been just a country club like arrangements. They are mired with internal politics, controversies and rivalries. Hence no serious efforts were made to maintain an up-to-date registry.
The reality is, doctors do not want to come under any control, restriction, supervision and monitoring. They want the total laissez faire, hence the resistance to change. Some have questioned the motive and right of an hospital administrator to write the article on CEA. If not him, has any medico or their association taken trouble to write about CEA?
Could you kindly mail me details and prices of the books you have written? I am keen to purchase a book or two.
With regards.
Major Prakash Patil (Retd)

 
Comment by Rajendran
2017-04-02 22:39:06

Sir iam Rajendran wants national seniority promotion please tn 613203

 
Comment by Rajendra
2018-01-22 16:25:57

Thanks a lot Sir.

Made few things clear.

My querry is..

Does every private hospital require a post of Medical Director / Manager, from this point of Act? What if a small nursing home / hospital, does not have that post.

Thank you..

 
Comment by Pawan Kumar Aryan
2018-03-10 15:01:11

What hell shall dawn if documentation is done, preserved and shared (if need be) regarding patients, diseases, diagnostic procedures, medication, advises etc by a competent medico.

CEA is nothing more than that.

Overall HUMAN-LIFE is at stake in these trying times when the pious glory of the profession has been engulfed by corporate looters.

The Indian doctors are killing female brood and preaching: “Do not kill a girl in womb.”

Who is responsible for conducting an abortion or inducing it abusing medicines?

Come on! be honest, overall a doctor is not above board.

Medicos are genius, no doubt in that, but why not to document the fact of a SUBJECT?

 
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