Clinical Establishment Act 2010 and Rules 2012
An independent authority rather than the Government, should be the regulator.
Accreditation and not licensing should be the process of registration.
All Treatment protocols of WHO, international and national professional associations should be accepted. Government should refrain from framing protocols.
Fixing of fees and charges for procedures is a gross interference into the profession. This should be withdrawn.
Stabilisation clause should be replaced by duty to provide first aid and primary care.
The onus of safe transport and its cost should be borne by the Government.
Objections to Treatment Protocols and Standards
Though the objections have been invited only on draft standards and protocols, IMA is submitting a comprehensive document to let our Government know of the current feedback from the medical profession across the country.
1. Government prescribing standard treatment protocols curtails professional choice. This may impact patient safety and expose the physician to litigations. Doctors should be free to choose any accepted line of management. IMA views this action as serious infringement on the profession’s independence. However, IMA admits to the privilege and duty of the Government to prescribe guidelines during epidemics and matters of public health importance.
2. IMA seeks from the Government favourable disposition towards hospitals and clinics in rural areas as well as all small and medium hospitals (Level I and Level II).
a) Infrastructure standards should be applicable to hospitals being established henceforth. Existing hospitals should be exempted.
b) Single window clearance needed for all the laws stated in respective annexures of different categories. Objections to individual law or license has been filed in the main document.
c) Need for doctor “ at site” to be modified to doctor “on call 24 x 7”
d) Qualified and /or trained nurses should be acceptable in nursing stations. Level 1 and Level 2 hospitals should be allowed to continue existing two shift system. Level 3 hospitals can adopt three shift system.
e) The right of exemption provided to a registered medical practitioner under Drugs and cosmetics Act 1940 and Rules 1945 should be protected and upgraded to institutions run by a husband and wife team(a common phenomenon in our country).A pharmacy license is not needed when medicines are dispensed by the registered medical practitioner.
f) Boilers License should not be demanded from hospitals
g) Space for biomedical waste treatment and disposal including the pit are unnecessary if the hospital /clinic is availing common treatment and disposal facility (CTDF). For the same reason incinerators are unnecessary. What all should be asked of the institution is to comply with the Environment Act including availing of biomedical waste treatment and disposal mechanism.
h) Tococardigraph and oxygen concentrator should not be mandatory in level 1 and Level 2 hospitals.
i) For Level 1 hospital in point 10 the list of basic processes should be reduced to include only 10.3 and 10.8.
j) A MBBS /MD doctor trained in dialysis should suffice for dialysis centers.
k) Minor urological procedures can be done by trained MBBS/or surgeons.
l) UGI endoscopy /colonoscopy and similar procedures may be done by trained MBBS/MD (Gen Med)/MS surgery)
m) 4 wheel drive in Level 2 hospitals is unnecessary
n) The list of licences and statutory obligations for medical imaging services needs to be curtailed as per scale of operation
o) Manual cleaning of endoscopic machines should be suffice.
p) Co2 monitor and such equipment are needed only in specialised centers.
q) More Minor procedures to be included for polyclinic with observation/short stay facility of minor OT and anaesthesia is integral part .Dressing and injections to be included.
Indian Medical Association
Clinical Establishment Act 2010, Rules 2012 and draft standards
Concerns, suggestions and objections to draft standards
Basis of IMA’s perspective on Clinical Establishment Act.
IMA has been working hand in hand with GOI and state Governments to facilitate good governance for the health of our people. India is uniquelyplaced amongst the nations of the world in having a dynamic private sector in health care alongside a strong public sector. IMA has two broad concerns which define its perspective:
1. Continued viability of small and medium health care institutions which are accessible and affordable to our people.
2. Continued relevance of clinical medicine as it is practiced in our country today pitted against the high cost evidence based medicine
Government as the regulator : an avoidable mistake
That it is the Government which is poised to regulate the hospitals and other health care institutions is a great disincentive. There is no other sector where the Government has intervened in such a large measure. The level of intervention proposed in the Act infringes on many fundamental rights and is likely to decimate the private healthcare industry. Elimination of small and medium players would be the most likely result of this Act. We shudder to think of a day when the friendly neighbourhood clinics would be gone replaced by corporate primary care. We are of considered opinion that the regulator should be an independent authority with Government support and participation. IMA would suggest that MCI or NABH or professional associations could be developed as one with constitutional and structural changes. Lessons learnt from Private Public Mix projects reveal considerable friction between the two sectors especially at the district and sub district
level While the bonafides of registration and standards are not in question, the same cannot be said about the Government machinery implementing the same.
Registration : views of Planning Commission
The central council of health and family welfare in its 5th Conference held in Jan 1997 resolved to register private hospitals. In good measure it added that the accreditation system would require to be studied. The working group on clinical establishments, professional services regulation and Accreditation of Health Care Infrastructure for the 11th Five-Year Plan set up by Planning Commission, Government of India (appendage1) observed that there is a need to empower panchayathi raj institutions to undertake registration. Significantly the expert group also observed that as for as possible, registration should be done on the basis of documents certified by licensed professionals such as charted accountants, approved valuators and assessors. The group strongly discouraged setting up of administrative paraphernalia for inspection. The group also noted that there is already a multiplicity of licensing authorities under various health related
Licensing Vs accreditation
The working group of the Planning Commission has defined licensing and accreditation in the following terms:
Licensure:a government administered mandatory process that requires healthcare institutions to meet established minimum standards in order to operate.
Accreditation:a process by which a government or non-government agency grants recognition to healthcare institutions that meet certain standards that require continuous improvement in structures, procedures or outcomes. It is usually voluntary, time-limited and based on periodic assessments by the accrediting body, and may, like certification, be used to achieve other desirable ends such as payment or funding.
The present Act has a licensing character which has evoked legitimate fear in the minds of the stakeholders regarding the license raj and its attendant negative fallout that would follow. The Government should carefully consider an accreditation model. Accreditation goes beyond compliance. It calls for excellence on continuing basis. This makes it market driven involving all stakeholders. Accreditation is also an established mechanism world over. The planning commission group had recommended that there could be several accrediting agencies like NABH and a national level body should be set up for overseeing the accrediting agencies.
Fixing of fees for consultation and rates for procedures
IMA has strong objections that the Act has abrogated to itself the power to fix the fees of various professionals and charges for various procedures . Apart from interfering with the right to practice a profession independently, there are serious concerns as to how diligently such a power would be used. Moreover in a vast country like ours where service charges tend to vary even within a district, arbitrary fixing of charges could either result in unnecessary taxation of the patients or on the contrary may end up in less remunerating prices for the hospitals. IMA is convinced that fixation of charges by the Government would be counterproductive and will help only the private health care industry.
Government protocols : an anti people move
The most serious fallout on the practice of medicine will however be prescription of treatment protocols by the Government. The Government should refrain from framing its own protocols. This will have deleterious effect on science in general and on advancement of medicine in particular. Courts will tend to look at Government protocols in preference to protocols by National and international professional bodies. Medicine is a science which outpaces itself in advancement. Government protocols will most likely fall behind time and may not be the best option for a patient. The way modern medicine crystallises is through thousands of publications before they become a standard treatment protocol. Moreover off label prescription is the privilege and right of doctors in the best interest of the patient. Plurality of opinion and diverse therapeutic options are an essential part of modern medicine. There are more than one protocol for all diseases.IMA suggests
to the Government that the Government should restrict itself to declaring that
All protocols by national and international professional bodies including World Health Organisation shall be acceptable. The professional bodies shall be empowered to update and or modify the protocols from time to time.
A hospital shall adopt a protocol for a given condition and shall have transparency in implementing the same.
Government however may issue guidelines to be followed by healthcare professionals and others during times of epidemics and for situations of concern to public health.
Comments on draft standards
Level 1 and Level 2 hospitals
1.Standards on infrastructure : harbinger of high cost healthcare
All infrastructural standards including space requirementsshould be prospective. No existing institution should be denied registration because of the newly issued standards. Application of any rule or standard with retrospective effect is against the principles of natural justice. The working group of the Planning Commission on clinical establishments for the 11th five year plan says that “Due care would have to be taken to avoid over emphasis on standards for infrastructure. Otherwise investments required to comply with standards might have a spiraling effect on service costs in the health sector. Greater focus would, therefore, be required on standards for service delivery”.
2. Legal requirements
2 a)Single window clearance
Multiple Laws and regulations have been enumerated on the annexures of all categories of health care institutions. IMA demands a single window clearance under Clinical Establishment Act for any law applicable on the hospitals and other institutions. This would ensure good governance and avoid red tapism. If for any reasons this is not possible these laws which are already in existence anyway should not be mentioned on the annexure of requirements. These NOCs/ registrations will have different time periods for validity not on conformity with the registration of institutions under CEA 2010.
2 b)Of utmost concern is Annexure 6 list of legalrequirements for minimum standards being prescribed for level I & II hospitals. AERB licences, Completion certificates, NOC from fire department, Deisel storage license, DG set approval for commissioning, Retail and bulk drug licence, Narcotic drug license, medical gases / explosive act license, boiler licences, Spirit license, NOC under Pollution control act, sales tax registration. It is also not clear what is being asked for under electricity rules. These licenses and registrations are being imposed to perpetuate and re-establish inspector Raj and all small and medium scale healthcare facilities will close down.
2 c)Need for a completion certificate in legal requirements isan example. Completion certificates are commonly refused for minor building byelaw violations and in any city this may include upwards of 60 % buildings. Also need of dependence on landlord for this requirement under CEA will close many healthcare facilities as the level 1 or 2 hospital may not be in a self owned premises. How the clinical standards of a facility is to be determined on the fact whether or not the building has completion certificate is a mystery. What this effectively means is that the facility has to apply to Estate office for completion, inspection of premises by inspector, objections, removal of these objections by any means.
2 d) The NOC from firedepartment , now under the new rules for hospitals whether level 1 or tertiary care, has extremely stringent requirements of roof top water tanks, sprinkler systems and smoke detectors. To get this NOC is going to be another formidable challenge for the establishments already in existence in older buildings.
2 e)There is also a need for Spirit license, medical gases /explosive Act license, boiler license and a wireless operation certificate from Department of Posts and Telegraph to operate wireless equipments like nurse call systems or monitors. It does not require high intellect to know how these licences are to be obtained and what the procedure entails. An individual or couple managing a small nursing home or level 2 hospital will find it impossible to comply with the requirements of all these certifications.
2 f)The category of Hospital level II needs to be dividedinto those less than 50 bed and those more than 50 bed. The hospitals less than 50 bed strength should be categorized under small scale units . The legal requirements for level one and two hospitals which are less than 50 bed strength should be very limited eg;
Permission from local authority / Estate Office / Municipal Corporation to run nursing home / hospital in the building. (Itis the Estate office / municipal corporation which consults with various Departments for clearances including Fire /Electricity / Water ).
Registration with Pollution Control Board for GeneratingBiomedical Waste.
Agreement with Common service provider for disposal ofbiomedical waste
Doctor’s registration in State Medical Council.
Registration under MTP Act if applicable.
Registration with Registrar Birth & Death.
Registration under PCPNDT Act if applicable.
ESI / EPF Registration if Employee strength is more than 20
PAN Nos / TAN Nos
3.: “ Doctor at site “ (annexure 5 ), Small and medium hospitals run by doctors do not have the doctor at site. However the doctor is normally available 24x 7 in the residence adjacent to the hospital. Prescribing “doctor at site” as a standard will achieve very little while putting the doctors to a great disadvantage The same should be changed as” doctor on call in reasonable time”.
4.Nurses : The status analysis survey conducted by IMA for QCI has shown that it would be impossible to staff all the nursing stations in all shifts in all hospitals with qualified nurses. It is a given fact that so many qualified nurses are not available in India. It is also pointed out that the NABH recommendations to the Government of India on this aspect speak about qualified / and or trained nurses. Rural hospitals will be at a greater disadvantage to employ and retain qualified nurses. Moreover it has been conclusively shown that nurses working in two shifts are more satisfied and commit less mistakes than their counter parts working in 3 shifts. Level 1 and level 2 hospitals should be allowed to retain the two shift system ( appendage 2(a) appendage 2(b) (appendage 3). It is also reiterated that occupancy ratio in private sector should be a general guiding factor in determining the number of nurses in a hospital.
5.Boilers license :IMA objects to the application of boilers licenses to hospitals. A judgement of Madras High court in this regard is cited (appendage 4)
6.Incinerator and Biomedical waste treatment and disposal: In many states Common Treatment and Disposal Facilities(CTDF) have been established (Eg :Kerala) Separate incinerators in each hospital will be a nightmare to the country. The requirement should be corrected as ‘arrangement for biomedical waste management as per law instead of incinerator.
7.Tococardiograph :Prescription of Tococardiograph for Level 2 hospitals is out of reality. However the same would be in order in Level 3 hospitals.
8. Oxygen Concentrator :The requirement of Oxygen concentrator for level I and II is unjustified. Quality service could be provided without concentrator. Such an investment will only increase the cost with no additional benefit
9.Inj Diclofenachas come under closer scrutiny because of extinction of vultures due to renal damage due to widespread abuse in veterinary usage. The same may be dropped from essential list in Annexure 4.
10. Clarification needed on whether AYUSH resident doctors maybe employed in Level I allopathic hospitals as mentioned in Definition. This would be against the Hans Charitable Hospital judgment of NCDRC. There however is a universal need for Resident doctors and this should be fulfilled by including Foreign Medical Graduates who have not passed the MCI / NBE conducted exam who should be allowed to work under supervision as resident doctors in Level I & II less than 25bed hospitals.
11.There is no need for a 4 wheel drive vehicle in a Level2 hospital in the city. All hospitals are not located in remote areas. In a city a 4 wheel drive is unnecessary.
12.For dialysis centers in India where a population of 2.5 laca year are added yearly to the already existing 1 cr plus population of Chronic Kidney Disease and only 10 % of these patients are able to get specialized care, and 90 % do not get any care. With only 1200 -1500 DM Nephrologists in the country to expect a DM Nephorology to visit each and every dialysis center. A trained MBBS / MD with sufficient dialysis experience should be adequate.
13.This is also true for minor urological procedures which canbe done by surgeons or even MBBS, UGI Endoscopy / Colonoscopy which can be done by MD Medicine, MS surgery and other similar procedures.
14.In Standards for Medical Imaging Services the list oflicences and statutuary obligations needs to be curtailed as per scale of operations. A simple ultrasound machine in a clinic , or a C Arm in OT of a level II hospital with less than 25 beds is in no position to fulfill suchlike obligations and this effectively restricts appropriate and widespread use of technology. Standards keeping in view scale of operations need to be designed. Also need of radiologist simply to operate a C Arm will put added burden on small hospitals with occasional need of C Arm
15.Annexure 3 Endoscopic cleaning machines are still not routinelyused in even premier institutes and manual cleaning is the norm. CO2 monitor and many other similar equipment are mentioned which may not be needed in places not running ICU.
16. Pharmacy license is not required if the practitioner is single or even if they are a group/husband –wife team (Rights acquired individually are not lost collectively.)
17. For Clinic with short stay;a. At point 9.1 it is mentioned that records for Notifiable diseases under IDSP Project as per Annexure VII is to be maintained but there is no Annexure VII given b. Need for infantometer for polyclinics with short stay on pg 16 is unnecessary
18.When the provisions of Clinical Establishment Act areclubbed with the draft Minimum Standards some other issues crop up. The provision of responsibility of stabilization and transfer of patients during emergencies under the CEA Act imposes on level 1 & II hospitals and solo clinics requires them to keep own ambulances / vehicles because they are responsible for the safe transfer of patients to higher levels. The draft minimum standards does not require so but the Act itself with its provisions leaves only two options
a) In this situation to avoid liabilities they have to either haveown vehicle and 24 hrs driver facility with stand-by vehicles with required doctors and para medical staffs with the vehicle during the transfer of patients, which may not be feasible for small establishments OR
b) They have to be some kind of franchisee of any corporate hospitalswho can or will provide such facility 24hrs to transfer patients.
19) For Polyclinic with observation / short stay
a) Definition needs to include minor procedures like Upper GIEndoscopy, Colonoscopy, bronchoscopy, laryngoscopy, sigmoidoscopy even diagnostic laproscopy, cystoscopy.
b) There are number of other minor procedures which requireshort stay clinics like urologists where catheterization, urethral dilatation may be performed. Similarily for esophageal stricture dilatation, achalasia balloon dilations, Colonoscopic polypectomy, Variceal band ligation a Polyclinic with short stay is the ideal to keep cost of procedures down as well as provide safe post procedure care.
c) Even chemotherapy is given on short stay basis and shouldbe part of the list of procedures which can be done in such establishments. Bone marrow aspiration, ultrasound guided FNAC, all these require short stay / observation but not hospitalization.
d) Facility of minor OT and facility for anaesthesia is integral part of such setup.
e) Dressing and injections will need to be given inPolyclinic only consultation and this is already included in the definition of such Clinical Establishments. So for Polyclinics with short stay procedures mentioned above are the appropriate procedures.
f) If we see the Annexure 5 list of Emergency drugs forpolyclinics only consultation we find, IV fluids, , Inj Adrenaline, In Deriphylline, Inj Frusemide. If these injections are intended to be used basic observation is needed even in these clinics. So the category of Polyclinics with short stay obviously cannot be only to give injections and do dressings but for small procedures mentioned above.
IMA submits to the Government that small and medium (Level 1, Level 2) hospitals and clinics are holding the healthcare cost down in India.(appendage 5). Statistics shows that they are disappearing at alarming rate.(appendage 6) The clinical Establishment Act 2010 and Rules 2012 as well as draft standards and protocols are bound to expedite this process. Moreover clinical medicine as practiced in India shall disappear forever like in western Countries (appendage 7). We urge caution to hasten slowly. Otherwise India might have to face a dark age in healthcare.
Report on the Working Group on Clinical Establishments, Professional Services Regulation and Accreditation of Health Care Infrastructure For the 11th Five-Year Plan.
2(a) Public Health Briefs Rotating Shift Work, Sleep, and Accidents Related to Sleepiness in Hospital Nurses
2(b) Differences in Medical Error Risk among Nurses Working Two- and Three-shift Systems at Teaching Hospitals: A Six-month Prospective Study
3 Report on the working hours of nurses in private hospitals prepared by the committee constituted for the study report on the working hours of nurses in private hospitals (Government of Kerala)
4 Judgement of Madras High court.
5 Thiruvananthapuram medical college-SSP study reported in the Hindu
6 Private hospitals and hospitals beds facilities in Kerala 1986,1995 and 2004,Governemnt of Kerala.
7 Hyposkillia: an article published by Dr Herbert L Fred Prof. University of Texas
Dr Jitendra B Patel Dr Narender Saini
National President, IMA Hony. Secretary General, IMA