CLINICAL ESTABLISHMENT ACT,IMA & MINIMAL STANDARDS 

clinical establishment act- basics
why the government wants it. 
The government wants insurance in health sector.The insurance sector is hesitant to enter in an unregulated heath sector . Hence the act
Why the government is making a mistake.
 Insurance was introduced in American health care because American health care is inaccessible and very expensive. Indian health care is accessible and cheep. Insurance will make it more expensive, with more paper work for over burdened doctors.
Danielle Ofri on what plagues American medical system ,one of the costliest in the world writes that insurance and consumer affair concerns makes American doctors do too much of paper work which is more than the time spent in treating patients.This is what we are trying to imitate.IMA proposes that section of the act which entails reporting data of the patient be withdrawn completely.Other than notifiable communicable diseases , no data will be provided to the government as it will hamper direct patient care,considering our large population.
why the doctors don’t want it.
 The government does not provide any support monitory or otherwise to private sector which is catering to 70 % of the population. The conduct of private sector which works on the demands of the market forces which has proved to be the best regulator, has been exemplary. Just ask a passer by whether he will go to paid private service or free government services. He will definitely like to go to private sector.
The market has seen the ill effects of inspector raj. Why the government wants to impose inspector raj when it is talking of deregulation and delicensing in other fields. It will only hamper an efficiently working sector.
Private doctors have their constitutional rights about when and how they want to work and to choose type of work they are comfortable with. To ask any clinician for example a yoga teacher (who seems to be covered in the act as a clinical establishment) to stabilise an heart attack under threat of persecution is asking for trouble. Going by the same analogy will the government ask all the restaurant owners to feed a hungry incomer without any compensation. The whole idea is absurd. Ethically every doctor does his best to help the patient in distress. Wasting time in stabilisation can result in accusations from angry and impatient relatives with threats of violence; and in this era of consumer courts, asking for disaster.
There is huge shortage in trained manpower particularly nurses. To ask all hospitals to have trained nurses in small clinics and nursing homes may not be possible.
Minimal standards list is like a list for essay for a competitive exams not taking into consideration that will ultimately will increase in the costs to the patient per se. With a poor indian population American standards are being enforced. Brings to mind the COBRA ,EMTALA AND 250 Yards rule of American health care. All very laudable but is American health care so good. It is prohibitively expensive and inaccessible,appointment can take months to materialise. So dear government, make your own laws , don’t ape America. 
The act lays down monitory penalties for non compliance which are more than the penalties for INDIAN PENAL CODE. Are doctors doing any illegal activities to be harassed like that.
Clinical Establishment Act . . . The long story
The vedas have long ago stated the fact that in kaliyug the do gooders would be hounded out and the the corrupt would flourish.The clinical establishment act seem to fulfils this professy not in parts but in full measures
Starting with COBRA and EMTALA in American health care legislation,the Indian government has also initiated its own version of COBRA AND EMTALA . The CLINICAL ESTABLISHMENT ACT.The point is -India is not America.
What would be the disadvantage of the act.
There are stringent and huge monitory penalties for non registration by any medical professional which are more than many criminal penalties of IPC.

What would the CEA lead to in most of the regions of the country –

1. Healthcare which is already expensive would become more expensive.

2. Healthcare would become inaccessible to most of the Indian poor unless they live in a state which has good public healthcare.

3. Specialists would become more in demand. Their salaries would rocket sky-high

4. Most of the small nursing homes and hospitals especially mission hospitals would have to be closed down.

5. Healthcare would become an industry rather than a service

This Act is a step towards corporatisation of healthcare. All small units of healthcare like clinics will not be able to survive if this Act is introduced. It has been made keeping the foreign countries in mind and this is the biggest flaw in it. According to the Act, each clinic should have one nurse and pharmacist each despite the fact that the WHO, in a 2010 report, has revealed that India is grappling with shortage of medical staff.”

“At least 70% of the total health services in the country are provided by clinics and they should not be restricted through the guidelines of this Act. Also, medical facilities in rural areas are already in a bad shape and with the requirements being asked at a medical establishment, it is next to impossible to run a clinic in rural areas. Not only will this be a problem for doctors as it needs high investment but also for the patients who will have to bear high cost.”
It’s worthwhile looking at a statement made by the IMA back in 2010 in this regard:
“The sincerity of the govt. may be appreciated, if it initiate[s] and strives to eradicate the quacks and quackery from our country which has been crippling our society’s health in the guise of providing first-aid care….[putting] corporate hospitals and rural area hospital in same line to accredit-ate is unjustifiable as it favours corporatization of health care and jeopardising the health services within reach of common man”

Unresolved issues in the Act
While in many ways a regulatory framework is essential, there are still unresolved problems with the Act. Some of them are listed here.
Section 12(2) 

It states thus: “The clinical establishment shall undertake to provide , such medical examination and treatment as may be required to stabilise the emergency medical condition of any individual who comes or is brought to such clinical establishment.”
What this boils down to is that all clinical establishments are expected to stabilise a patient in an emergency medical condition before transferred to another hospital..” But one doesn’t have to stretch the imagination to see that its interpretations can vary.
The original Supreme Court directive on this regard was meant for providing life-saving first aid for victims of accidents. It’s quite unrealistic-and potentially unfair to the doctors to extend this to any and all emergency situations.
Lack of provision for extra machinery for additional workload of regulating private clinics

In this backdrop, it’s hard to see how a fair implementation of the Act is possible-affecting not just the doctors but also the patients. For instance, the Act has called for the establishment of the National Council-which is supposed to have a special secretary: the director-general(DG) of health services, Ministry of Health and Family Welfare as an ex-officio member and chairperson.
This implies that important decisions could be delayed if the DG cannot squeeze out more time for this additional task. There are to be no additional appointments at the state level to manage this work. And at the district level, the situation could be potentially worse. For in the districts the chairperson and the secretary of the registering authority are to be the district collector and the district health officer respectively. Needless to say, this increases their workload by a long stretch, causing further delays in getting things done.
Those who wish to appeal against the order of the district health authority must approach the state council

Even if a marginal number of establishments from a state wish to go for an appeal, this would amount to a substantial volume of appeals from within distinct district registering authorities. But the doctors must approach the state capital for matters related to the disputes. That’s on ordeal that could be avoided with a simplified provision.
These are but a few of the issues that one find in the Act, giving the doctors substantial basis for opposing it.
Such issues point to the necessity for a more involved discussion between the government and the medical fraternity. The key issue here is the provision of adequate healthcare to a huge number of people. And it’s the state’s job to ensure that care-givers, regardless of the size of their institutions are able to provide that in the best possible manner, facing minimal hassles.

I personally have much misgiving to the regulations of the Act in the present form.
1. In a country like India which is very vast and the majority of the population (about 70%) lives in villages, it is going to be very difficult for anybody to set up hospitals in semi-urban and rural areas. The stipulations are going to be very hard to meet that setting up a hospital would hardly be a profitable venture. The other side is that even if hospitals are set up, the cost of care would be quite expensive. Almost all of us have mostly depended on small clinics or nursing homes which are run by a single doctor with the help of a nurse or by a doctor family. In fact, quite a lot of us may have knowingly or unknowingly gone to a unqualified practitioner or quack for our small medical problems. At present I live in a place where almost 95% of the population go to a quack first for treatment. They have bungled up cases where the patient ultimately died. However, nobody has been able to do anything. The only reason being that these guys are the only people who have some knowledge about medicine in remote settings. And they come very cheap. The regulations appear to be giving more importance for corporate multi speciality hospitals. This is quite protectionist in nature towards encouraging a corporate model which will ensure that healthcare is only available at a premium in the absence of an efficient public health care system.

2. There is enough scientific evidence that family practice and nurse practitioner based primary care is as efficient, and rather more people friendly than specialist doctors in full fledged hospital set ups.

3. If you consider any of the complex clinical conditions one can think of, the primary level of care is much more important than high tech healthcare. We have examples of countries like Brazil and South Africa, where Family Medicine graduates have major role in healthcare. The present regulations would only increase costs. If you look at the regulations, the first level of treatment is going to be a Level 1 Hospital which needs to have a staffing of at least 6 for a place which do not have inpatient care.

4. Most of our tertiary care centres are burdened with primary care. It is not uncommon for any faculty in our medical colleges who end up complaining that most of the patients that they see could have been easily managed at a Primary Health Centre or even by a Nurse practitioner. The ultimate result is that quite a many of our specialists are over-worked to the extent that they are not able to do justice to the specialised skills they’ve obtained.
If we can think of changes that can be proposed, I would propose the following –
1. Legalising Nurse-Practioner Care: Nurses should be trained to treat simple illnesses allowed to prescribe medicines. A major need would be to allow a category of health centres which are entirely run by nurses who may or may not supervised by doctors. At least for populations who have poor access to healthcare, they would be a major boon. In fact, such nurse-led primary care centres have already been in existence in the country, mainly facilitated by various congregations of the Catholic Church.

2. Provision for single doctor healthcare centres: We are all very familiar with such single doctor establishments. A 100 square feet room with a familiar friendly face to whom you ran when you had a toothache or a cold. You pay about 50 rupees and then you pay some more for the medicines and some basic investigations. The whole process took not more than half an hour. If the regulations in it’s present form are accepted and finalised, the family doctor would be history.

Section 55 of the act enlists the ‘Rights of patients’ as follows:

(1) The patients and / or Person authorised by patient shall receive the relevant information about the nature, cause of illness, proposed care, and the expected results of treatment, possible complications and the expected costs.
(2) Confidentiality of treatment and privacy during examination. Examination of female patient should be carried out in presence of female attendant.
(3) Person suffering from HIV/AIDS shall not be denied care.
(4) Complaint register should be made available in Clinical establishment.
(5) List of Specialists along with Qualifications Should be displayed at prominent place in Clinical establishment.
(6) Patient has the right to seek second opinion. All medical and diagnostic reports shall be made available to the patient or authorised person to facilitate second opinion.
(7) Patient and / or Person authorised by patient or guardian if patient is minor has a right to have an access to his / her clinical records during admission to Clinical establishment and Photocopy of indoor papers should be made available on demand after discharge.
(8) Discharge card should be issued to patient mentioning: Diagnosis, clinical findings, results of investigations, treatment given, the patient’s condition at the time of discharge and advice to patient.
(9) Patient has right to choose registered pharmacy or recognised diagnostic centre at his / her own responsibility.
(10) Protection ensured by statutory guidelines and legally enabled provisions applicable to Clinical Establishments which are conducting clinical research.
(11) Informed consent prior to potentially hazardous tests / treatment.
Thus, if the intents of the Act are preserved, it is likely to benefit both-the patients and the health care service providers alike.

Cl. 5 empowers the government to develop ‘proper’ as well as minimum standards for healthcare. The latter alone is to be applied in reviewing the state of any facility. In a country with limited information about the nature and quality of healthcare, no national program for development of practice guidelines or medical review criteria (World Bank Report, 2003) in addition to vast regional and social disparities, creating such standards will be quite a difficult task. The RWG acknowledges this (para 37) and being a long-drawn process, recommends delinking it from registration (para 40(x)), a view incorporated in the draft bill.
Cl. 10 designates the District Health Officer (DHO) or Chief Medical Officer (CMO) as the district registering authority for registration of clinical establishments in each district. The DHO/CMO also shoulders responsibilities for the management of government facilities in that district. This leads to a conflict of interest.
.
. How will better regulatory standards impact this? Cl. 42-44 allow the government to levy fines for failing to conform and a proviso to cl. 32(3(b)) allows for the institution to be restrained from ‘carrying on’ if there is imminent danger to the health and safety of patients. As mentioned before (vide supra), with the DHO/CMO holding overall responsibility for government facilities in the district, the ensuing conflict of interest makes it quite unlikely that he/she would be willing to take strong action against erring individuals or facilities. Apart from this, the coercive impact is blunted as any fine levied is merely one arm of the government paying another. There may be more severe consequences if a facility is actually forced to shut down for non-compliance. That is however likely to be a rare event; if it is serious enough to scandalise the government or even otherwise jolt it into action, the finger will once again point to the very DHO/CMO who ordered it. Thus, even if better accountability standards are developed and adopted, these constraints are likely to hamper their effective implementation.

The Indian Medical Association (IMA) which has consistently resisted state regulation, not surprisingly, came out against this particular effort also. As it alleges, this is, in a sense, a return to the license-permit raj with registration and inspection becoming potential focal points of corruption.

The Act applies to all “clinical establishments” defined under Section 2 (c). The definition is an unnaturally wide one, and includes hospitals, maternity homes, nursing homes, dispensaries, clinics, sanatoriums and institutions that offers services or facilities requiring diagnosis, treatment or care for illness, injury, deformity, abnormality or pregnancy, in any recognised system of medicine. “Recognised system of medicine” under the Act covers Allopathy, Yoga, Naturopathy, Ayurveda, Homeopathy, Siddha, and Unani systems of medicine, as well as any other system of medicine that may be recognised by the Central government. Every conceivable range of treatment is sought to be included within the parameters of the Act. Under Section 11 of the Act, no person can run a clinical establishment unless it has been duly registered in accordance with the provisions of the Act. A severe monetary penalty is provided under the Act for carrying on an establishment without registration.
This in itself would not be overly onerous, if it was not for the extremely unreasonable standards that the Act mandates every clinical establishment, in every recognised system of medicine, to have. Section 2 (d) of the Act incorporates a very vast definition of ‘emergency medical condition’ (which includes symptoms of sufficient severity, including severe pain, that may cause serious bodily impairment or dysfunction), and imposes on every clinical establishment, the duty to provide facilities ‘to stabilise’ an ‘emergency medical condition’ and to provide such medical treatment necessary to assure within reasonable medical probability, that no material deterioration results during the transfer of the individual from a clinical establishment. What this effectively means is that if a person has a heart attack and is taken to a Yoga centre, the Yoga centre must provide for the minimum medical treatment necessary to ‘stabilise’ him, in terms of the definition above. Quite clearly, this seems like an unworkable and even an unconstitutional onus to impose.
The above features of the Act curtail the right of medical practitioners to carry on their occupation, under Article 19 (1)(g) of the Constitution of India, 1950. The Act forces clinical establishments to provide services that they may not wish to provide at all. Implicit in the right to carry on an occupation under Article 19 (1)(g) is the right not to carry on a particular occupation. While this obligation is imposed, the Act is completely silent on how these clinical establishments will be remunerated for the services to be provided under the Act. This obligation of the State to improve public health is being transferred to the private establishments, in the guise of regulation.
The Act also seems to suffer from the vice of excessive delegation of non-delegable functions. Section 3 of the Act establishes a ‘National Council’ with the powers of classifying all clinical establishments and developing minimum applicable standards. Under Section 12 of the Act, every clinical establishment must have these prescribed conditions of minimum standards and requirements necessary for registration and continuation. Therefore, the Act purports “to prescribe minimum standards of facilities and services” and to “determine the standards for clinical establishments”. No such prescription of any standards for facilities and services, are however discernible from the text of the Act. Instead, the Act delegates this essential legislative function to the Central Government and the National Council, empowering them to prescribe the necessary standards. To impose a stringent regulatory regime, without prescribing the parameters of the regime and any guideline based on which the delegate can formulate minimum standards, seems to me an abdication of the constitutional duty to lay down the law and an unconstitutional delegation of non-delegable powers to the Executive.
Not unsurprisingly, a lot of medical associations and doctors who have become aware of this legislation, are strongly opposing it. The Act, applicable to the Union Territory of Chandigarh, was recently challenged in the Punjab and Haryana High Court, but the challenge was withdrawn as premature because the Act was yet to come into force through a notification. Nevertheless, what is being argued is that, the conditions that are sought to be imposed under the Act, can only be provided by large scale, multi-specialty hospitals, and therefore in the guise of providing a regulatory framework, the Act will virtually eliminate small and medium-scale clinical establishments, creating a monopoly in favour of large hospitals.
The Act therefore may have the completely opposite effect of the object it seeks to achieve. Instead of improving the standards of public health, it may lead to depriving several millions of people of adequate healthcare facilities, which are provided by individual doctors or small clinical establishments. While the regulation of clinical establishments is important, the Act as it stands today, is discriminatory and vague, and in my opinion, will not meet the strong constitutional objections that will be raised against it in the future.

 

The bill unleashes license raj with powers of penalties upto 5 lacs .The registering authority can impose fines for non compliance and if a CE fails to pay the same ,it would be recovered as an arrears of land revenue.
The penalties are stringent and for first offence the penalties are more than that in IPC. For first offence it is 1000 INR ,then for second offence it is 50000 and for third offence it is 5 lacs. Disobeying any direction or obstruction to inspection entails Rs 5 lac penalty.
The bill unleashes licence Raj with draconian powers to the inspectors with little provision for appeal.
Are doctors doing some illegal work to be harassed like this 

IMA proposes that the act should not be implemented at all. If at all government is adamant and hell bent it should be such the single doctors clinics to be considered for minimal registration only without applying strict rules.The provision should be prospective in implementation and old clinics and hospitals should be excluded.
IMA wants that only those establishment with indoor facilities should be included in the act.Also till date existing establishments should be exempted from the provisions of the act.
IMA Proposes that the requirements of pharmacist and clinical psychologists in various places should be done away. Pharmacists are not needed as most drugs are formulated and psychologists are mostly non medical persons masquerading as doctors.
IMA proposes that the ethics and rules are different and should not be intermixed. Stabilising a patient is ethical and making a rule is like asking an inappropriate person to treat the disease and waste time in referral.
Danielle Ofri on what plagues American medical system ,one of the costliest in the world writes that insurance and consumer affair concerns makes American doctors do too much of paper work which is more than the time spent in treating patients.This is what we are trying to imitate.IMA proposes that section of the act which entails reporting data of the patient be withdrawn completely.Other than notifiable communicable diseases , no data will be provided to the government as it will hamper direct patient care,considering our large population.
Clinical Establishment act

Minimal standards of clinical establishment 

IMA proposals are …

 

The bill unleashes license raj with powers of penalties upto 5 lacs .The registering authority can impose fines for non compliance and if a CE fails to pay the same ,it would be recovered as an arrears of land revenue.
The penalties are stringent and for first offence the penalties are more than that in IPC. For first offence it is 1000 INR ,then for second offence it is 50000 and for third offence it is 5 lacs. Disobeying any direction or obstruction to inspection entails Rs 5 lac penalty.
The bill unleashes licence Raj with draconian powers to the inspectors with little provision for appeal.
Are doctors doing some illegal work to be harassed like this 
IMA proposes that the act should not be implemented at all. If at all government is adamant and hell bent it should be such the single doctors clinics to be considered for minimal registration only without applying strict rules.The provision should be prospective in implementation and old clinics and hospitals should be excluded.
IMA wants that only those establishment with indoor facilities should be included in the act.Also till date existing establishments should be exempted from the provisions of the act.
IMA Proposes that the requirements of pharmacist and clinical psychologists in various places should be done away. Pharmacists are not needed as most drugs are formulated and psychologists are mostly non medical persons masquerading as doctors.
IMA proposes that the ethics and rules are different and should not be intermixed. Stabilising a patient is ethical and making a rule is like asking an inappropriate person to treat the disease and waste time in referral. If he dies in time wasted in stabilisation in wrong hands who is responsible 
Danielle Ofri on what plagues American medical system ,one of the costliest in the world writes that insurance and consumer affair concerns makes American doctors do too much of paper work which is more than the time spent in treating patients.This is what we are trying to imitate.IMA proposes that section of the act which entails reporting data of the patient be withdrawn completely.Other than notifiable communicable diseases , no data will be provided to the government as it will hamper direct patient care,considering our large population.
Minimal standard of psychiatry clinic.
There are psychiatrists who are using ECT , there are that don’t. A mandatory requirement of ECT Machine with EEG monitoring with boyles apparatus is suggested. 

 An annual maintenance record to equipment is mandatory.

Blood storage unit is mentioned
IMA proposes these be scrapped.
Minimal standards for deaddiction centre.
Requirement ofMBBS DOCTOR 

one nurse head,general nurses and two nurses for ICU/OT/HDU

ONE LAB technician 

ECG technician

dietecian 
physiotherapist

psychologists 

medico social worker

driver

ambulance 

data entry operators

policy manpower 

annual maintenance contracts 

laboratory 

imaging

pharmacy

sterilisation 

laundry 

kitchen

medical gas

blood bank

ambulance service
IMA PROPOSES THAT All THE ABOVE Be SCRAPPED 

PSYCHIATRY SERVICES IN HOSPITAL 
MBBS DOCTORS FOR DAY AND ANOTHER FOR NIGHT 

NURSING HEAD,NURSES AND TRAINED NURSES FOR ICU,OT AND HDU

PHARMACIST 

LAB TECHNICIANS 

X RAY TECHNICIAN 

ECG TECHNICIAN 

DIETICIAN

PHYSIOTHERAPIST 

PSYCHOLOGISTS 

MEDICO SOCIAL WORKER

MRD OFFICE STAFF

AMBULANCE 

DRIVER

DATA ENTRY OPERATOR

HOUSE KEEPING 

RAPID RESPONSE TEAM

BLOOD STORAGE UNIT

BOYLES APPARATUS 

LABORATORY 

IMAGING

KITCHEN

LAUNDRY

MEDICAL GAS

IMA FEELS ALL THESE ARE UNNECESSARY AND BE SCRAPPED. FOR EXAMPLE ALL PSYCHIATRIC WORKERS USES STERIWARE SYRINGES.WHAT IS THE NEED FOR STERILISATION  

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