(TABLE FORMAT WITH RATIONALE FOR CHANGES)
(Suggested changes by consensus have been italicized
and underlined for easy identification. This consensus emerged during the
meetings on 10th March
and 21st April 02, in
Mumbai amongst representatives of CEHAT, Association of Medical Consultants,
Mumbai, Forum for Medical Ethics, ACASH, WACHA, Women's Centre, Health Committee Lokvidnyan Saanghatana Pune.)
AMENDMENTS
TO
The
Existing Provision
& Proposed Changes
Incorporating the Proposed Changes / Incorporations
from the
Stakeholders Workshop (
Submitted
by
Sunil Nandraj
July, 2001
DEPARTMENT OF PUBLIC HEALTH
GOVERNMENT OF
MUMBAI
CONTENTS
1) Short title,
extent and commencement
2) Definitions
3) Prohibition to carry on nursing home without registration
4) Application for registration
5) Registration
6) Penalty for non-registration
7) Cancellation of registration
8) Notice of refusal or of cancellation of registration
9) Inspection of nursing homes
10) Income of local supervising authority
11) Expenses of local supervising authority
12) Penalty for offences under Act
13) Offences by corporations
14) Court competent to try offences under Act
15) Indemnity to persons acting under this Act
16) Rules
17) By-law
18) Saving
New sections to be incorporated in the Act / Rules
Furnishing of information
Constitution of the competent authority and advisory committees
Minimum requirements of clinical establishment
Obligations of clinical establishment
Engaging government servant
Display of fees, costs and rates for various services
Power to remove difficulties
Miscellaneous
ANNEXURE I
ANNEXURE II
Short title, extent and commencement
Section 1
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Existing provision |
Proposed changes / Incorporation |
Rationale for changes |
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1 |
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The |
Comprehensive act would cover all private and government (Central, State, Municipal, Zilla Parishad, autonomous) clinical establishments. |
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2 |
Presently applicable to the cities of Mumbai, Pune, |
Whole state of |
Should cover both rural and urban areas of the state |
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3 |
The act shall come into on such date as may be specified in the notification |
They shall come into force on the date of the notification in the Maharastra Government Gazette |
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Definitions
Section 2
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Existing provision |
Proposed changes / Incorporation |
Rationale for changes |
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Nursing Homes "any premises used or intended to be used, for the reception of persons suffering from any sickness, injury or infirmity and the providing of treatment and nursing for them, and includes a maternity home; and the expression 'to carry on nursing home' means to receive persons in a nursing home for any of the aforesaid purposes and to provide treatment or nursing for them". |
Nursing Homes "any premises used or intended to be used, for the reception of persons suffering from any sickness, injury or infirmity and the providing of treatment and nursing for them, and includes a maternity home; and the expression 'to carry on nursing home' means to receive persons in a nursing home for any of the aforesaid purposes and to provide treatment or nursing for them". |
No Changes |
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Maternity Homes "any premise used or intended to be used for the reception of pregnant women or of women in or immediately after child birth". |
Maternity Homes "any premise used or intended to be used for the reception of pregnant women for normal delivery, this would exclude those not having OT. |
Need to differentiate between those providing surgical and those not providing surgical Though it is desirable that a maternity home should have a surgical facilities for caesarean section, this is not possible in many villages, small towns. Instead of closing such facilities, they can continue to play a role in rural area. |
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Qualified medical practitioner “a medical practitioner registered under the relevant Medical Act in force” |
Qualified medical practitioner “a medical practitioner registered under the relevant Medical Act in force” It would mean “a person who possesses any of the recognized medical qualifications and who has been enrolled in the register of the respective Medical Council. Viz., Allopathy, Dental, Homeopathic and Board of Indian Medicine or any such council, Board or any other statutory body recognized by the government”. |
Need to be more specific and mention various systems of medicine, dentists and make it more specific to only include those recognized by the various medical councils |
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Qualified midwife means “a midwife registered or deemed to be registered under the Bombay Nurses, Midwives and Health Visitors Act, 1954 or any other corresponding law for the time being in force” |
Qualified midwife means “a midwife registered or deemed to be registered under the Bombay Nurses, Midwives and Health Visitors Act, 1954 or any other corresponding law for the time being in force” |
No Changes |
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Local Supervisory Authority “In case of 'district' local board' means any area other than a municipal area, means a district local board, district board, district panchayat or Janapada Sabha or similar local authority established under any law for the time being in force relating to the constitution of such authorities and having jurisdiction over such area;” 'municipality' means a municipal corporation, municipality, municipal committee, town committee or similar local authority established under any law for the time, being in force relating to the constitution of such authorities and 'municipal area' means the local area within the jurisdiction of a municipality;” |
Local Supervisory Authority “In case of 'district' local board' means any area other than a municipal area, means a district local board, district board, district panchayat or Janapada Sabha or similar local authority established under any law for the time being in force relating to the constitution of such authorities and having jurisdiction over such area;” 'municipality' means a municipal corporation, municipality, municipal committee, town committee or similar local authority established under any law for the time, being in force relating to the constitution of such authorities and 'municipal area' means the local area within the jurisdiction of a municipality;” |
No Changes |
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Prescribed: means prescribed by rules made under this Act |
Prescribed: means prescribed by rules made under this Act |
No Changes |
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Register: means to register under section 5 of this Act and the expressions' "registered" and registration shall be construed accordingly. |
Register: means to register under section 5 of this Act and the expressions' "registered" and registration shall be construed accordingly. |
No Changes |
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By-law means “By-law's made by the local supervising authority”; |
By-law means “By-law's made by the local supervising authority”; |
No Changes |
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Rules means “rules made under this Act”. |
Rules means “rules made under this Act”. |
No Changes |
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Clinical establishment means “any medical clinic (inpatient and or out patient), nursing home, maternity home, hospital, old age homes, day care centers, physical therapy establishment, in-vitro fertility clinics, medical laboratory / diagnostic Center, Radiological Centers / Panning Center, Physiotherapy Center, dispensary (with bed), medical institution / center of analogous establishment, by whatever name called: where investigation, diagnosis invasive procedure / curative medical treatment facilities are provided to the public”. |
Need to include all those providing health care both inpatient and out patient and from various systems of medicine. The definition of clinical establishment should only include Treatment centres managed by qualified medical persons who are registered under relevant laws and respective council,labarotories scanning centres, physiotherapy centres(to be differentiated from physical therapy centres) The other sectors should be brought under regulation of a separate Council for Alternative therapy. |
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Hospital means “a place where patients are treated as inpatients with facilities for admission as inpatients for treatment of illness without or with surgery or conduct of delivery and also includes other gynecological operations where women are received or accommodated for the purpose of sterlisation, hysterectomy, or medical termination of pregnancy. etc. with or without inpatient facilities”. |
Need to include and make it more comprehensive, for more specify |
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Medical Laboratory means “an establishment where bio-Medical, biological, clinical pathological, biopsy, bacteriological, radiological, microscopic, chemical, genetic investigations or any other diagnostic tests, examinations or analysis or the preparation of cultures, vaccines, serums or other biological or bacteriological products, in connection with the diagnosis or treatment of diseases, are or is usual carried on”. |
Need to include them since they do not come under any act and are major providers of health care. Laboratory should only include the centres where chemical,biochemical,bacteriological,radiological,pathological tests are done for diagnosis and treatment.This should not include places where vaccines/sera are prepared. |
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Physical Therapy Establishment means “an establishment where massaging, electrotherapy, hydrotherapy or similar work is usually carried on, for the purpose of treatment of diseases or of infirmity or for any other purpose whatsoever, whether or not analogous to the purposes herein before mentioned in this clause”. |
As this is another important aspect of medicine, it is necessary to include them. Since these disciplines themselves do not have any legal sanction as a profession, they can not be included in this act. |
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Scan Centre means “a place where Ultra Sound Sonogram, CT scan or MRI Scan tests are done including contrast studies and/or diagnostic and/or therapeutic procedures are carried out” and would also include any other advanced method of scanning. X-Ray centre means “a place where X-rays are taken or contrast studies are done” (excludes scanning mentioned above). |
As this is another important aspect of medicine, it is necessary to include them. MRI, CAT-scan centres need to be included in this act. However,The Medical Establishment should not be subjected to different registration procedures for different facilities it provides to the patients. Thus separate registration process to register as MTP centre, as sonology centre, as hospital etc. should be avoided. There should be a single form, with different annexures, to be submitted to a single authority. At least, there should be a single window system for registration under different acts. |
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Council means a council or any such body recognized by the government for the registration of the various practitioners. |
Needed to be more specific. |
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Disease means “a notifiable disease which a Registered Medical Practitioner is required to notify to the Medical and Health Officer of his area under the law for the time being in force”; |
Needed to be more specific |
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Medical Treatment means “systematic diagnosis and treatment for prevention or cure of any disease, or to improve the condition of health of any person through allopathic or any other recognized systems of medicine such as Ayurveda, Unani, Homeopathy, Yoga, Naturopathy and Siddha; and includes Acupuncture and Acupressure treatments”. |
Needed to be more specific Since there is no statutory council for acupressure, acupuncture, naturopathy, yoga-therapy, none of them can as of today be included in the BNHRA. |
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Competent Authority means “the committee constituted under this act to assist the local supervisory authority in discharging the functions under this act. |
To provide for a more participatory system of implementation. |
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Clinical Establishment Registration Board: means a board set up under the act to be an apex body for the implementation of the act, lay down minimum requirements (standards) or upgrade existing requirements periodically for different types of clinical establishments, appropriate number of types of clinical establishments in a geographical area and suggest revision of fees charged periodically. |
A body to provide for a platform, act
as a catalyst and be a conduit for developing standards, upgrading them, act
as an arbiter and examine the issue of health care establishments. Overall
for the implementation of the act and to provide for a leadership in better
health care delivery system for the state. The provision to control the
number of types of clinical establishments in a geographical area, though
desirable, would be challenged in the court ( freedom
to do business anywhere in |
Prohibitions to carry on nursing
home without registration
Section 3
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Existing provision |
Proposed changes / Incorporation |
Rationale for changes |
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No person shall carry on a nursing home unless he has been duly registered in respect of such nursing home and the registration in respect thereof has not been cancelled under section 7. Provided that nothing n this section shall apply in the case of a nursing home which is in existence at the date of the commencement of this Act, for a period of three months from such date or if an application for registration is made within that period in accordance with the provisions of section 4 until such application is finally disposed of. |
No person shall carry on a clinical establishment unless it has been duly registered in respect of such clinical establishment and the registration in respect thereof has not been cancelled under section 7. Provided that nothing in this section shall apply in the case of a clinical establishment which is in existence at the date of the commencement of this Act,for a period of three months from such date or if an application for registration is made within that period in accordance with the provisions of section 4 until such application is finally disposed of. |
Only changes in the term nursing homes to clinical establishment . The period for initiation of enforcement of this act should be 6 months in new areas. |
Application for Registration
Section 4
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Existing provision |
Proposed changes / Incorporation |
Rationale for changes |
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1 |
Every person intending to carry on a nursing home shall make every year an application for registration or the renewal of registration to the local supervising authority. Provided that in the case of nursing home which is in existence at the date of the commencement of this Act an application for registration shall be made within three months from such date. |
Every person /body intending to carry on a clinical establishment shall make every three years an application for renewal of registration to the local supervising authority. |
The registration would be valid for 3 years with a mandatory inspection An application for the registration / renewal of registration shall be made in advance in the prescribed form at least three months before the date on which the registration and the license are to expire and shall be accompanied by the fee prescribed. The local supervisory authority or any person authorized on its behalf and shall assign an acknowledgement number immediately if delivered at office or the local supervisory authority or within 15 days if received by post. The local supervisory authority on receiving the application form and various forms and details provided conduct physical checks of the premises and inspect the adherence to standards prescribed from time to time by the clinical establishment registration board or the rules framed under the act. After satisfying itself that the applicant has compiled with all the requirements and has the capacity to provide the services in an requisite manner place the application along with the required forms and recommendation before the competent authority for its advice. The competent authority shall advise the local supervisory authority as to whether the applicant be issued registration certificate. The competent authority may if necessary inspect the premises of the applicant before giving its advice. The local supervisory and competent authority shall dispose of every application received within three months from the date of receipt of application. The establishment would be deemed to have been registered in case there is no response from the local supervisory authority in four months from the date of application. |
The implementation would be proper if the registration is for 3 years. Inspection would ensure adherence to maintenance of standards. It would give sufficient time for the paper to be processed and make the necessary inspection Renewal reminder notice – A renewal reminder notice be sent by registered post by the LSA. 4 months in advance of the date of renewal. The charges for the same be included in the triannual service-fee to be charged to all the medical establishments, registered under this act. To make the implementing authorities more accountable. The clause about physical examination should be more specific and structured. The The person authorised to inspect and physically examine the place should have technical/medical expertise of the same specialty to which the the concerned clinical establishment belongs. Above mentioned qualification should also be made mandatory for Inspection by competent authority. It may be noted that the inspecting person need not be a doctor. Many of the minimum standards relate to infrastrutural facilities like space, water supply, etc and availability of trained human power and certain equipment. For inspection of up to secondary level health-care facilities, this can be done by a specially trained paramedic, and this would reduce the cost of regulatory/ monitoring mechanism. Specially trained doctors would be required only for tertiary level facilities, to check special equipments. The competent authority is not just a rubber stamp but is also provided powers. They have the final authority. This would ensure the participation of the various stakeholders in the implementation process To make the implementing authorities more accountable and ensure efficiency and make the implementing agency be pro active |
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2 |
Every application for registration or the renewal of registration shall be made on such date and in such form and shall be accompanied by such fee, as may be prescribed. |
Every application for registration or the renewal of registration shall be made on such date and in such form with information at least three months before the date on which he intends to start or carry on such clinical establishment and shall be accompanied by such fee, as may be prescribed |
It gives sufficient time for the local supervisory authority to inspect and give a proper well informed registration to the clinical establishment. |
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Rule (Section 4), 1973 |
Application for registration – Any person intending to carry on a nursing home shall make an application to the local supervising authority in Form 'B' at least one month before the date on which he intends to carry on such a nursing home. Such application shall be accompanied by a fee prescribed in sub-rule (1) of rule 7. |
Application for registration – Any person /body intending to carry on a clinical establishment shall make an application to the local supervising authority in Form 'B' at least three months before the date on which he/she intends to carry on such a nursing home. Such application shall be accompanied by a fee prescribed in sub-rule (1) of rule 7. . |
It gives sufficient time for the local supervisory authority to inspect and give a proper well informed registration to the clinical establishment. |
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Registration
Section 5
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Existing provision |
Proposed changes / Incorporation |
Rationale for changes |
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1 |
Subject to the provisions of this act and the rules, the local supervising authority shall, on the receipt of an application for registration, register the applicant in respect of the nursing home named in the application and issue to him a certificate of registration in the prescribed form. Provided that the local supervising authority may refuse to register the applicant if it is satisfied: a) that he, or any person employed by him/her at the nursing home, is not a fit person, whether by reason of age or otherwise to carry on or to be employed at a nursing home of such a description as the nursing home named in the application; or b) that the nursing home is not under the management of a person who is either a qualified medical practitioner or a qualified nurse among the persons having the superintendence of or employed in the nursing of the patients in the home, or c) that in the case of a maternity home it has not got on its staff a qualified mid-wife; or d) that for reasons connected with the situation, construction, accommodation, staffing or equipment, the nursing home of such a description as nursing home mentioned in the application or that the nursing home or premises are used or are to be used for purposes which are in any way improper or undesirable in the case of such nursing home. |
1) Subject to the provisions of this act and the rules, the local supervising authority shall, on the receipt of an application for registration, register the applicant in respect of the clinical establishment named in the application and issue to him/her a certificate of registration in the prescribed form. Provided that the local supervising authority may refuse to register the applicant if it is satisfied: a) the clinical establishment is not under the supervisory management of a person who is qualified and registered in the council recognized by the government b) the rules and By-laws under the act are not followed c) recommendation and advice of the competent authority d) does not meet the minimum requirements laid down. e) used for purposes which are in any way improper or undesirable and not for those purposes registered. |
Only changes in the term nursing homes to clinical establishment The owner of the clinical establishment could be a non medical person but it should be under the supervisory management of a person who is qualified and recognized. |
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2 |
A certificate of registration issued under this section shall, subject to the provisions of section 7, be in force and shall be valid until the 31st day of March next following the date on which such certificate was issued. |
A certificate of registration issued under this section shall, subject to the provisions of this act, be in force and shall be valid for a period of three years from the date of such certificate issued. |
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3 |
The certificate of registration issued in respect of a nursing home shall be kept affixed in a conspicuous place in the nursing home. |
The certificate of registration issued in respect of a clinical establishment shall be kept affixed in a conspicuous place in the nursing home. |
Only changes in the term nursing homes to clinical establishment |
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Rule Section 5 (1973) |
Grant of certificate of registration – the local supervising authority shall if satisfied that there is no objection to registration, register the applicant in respect of a nursing home and issue to him/her a certificate of registration in Form 'C' |
Grant of certificate of registration – the local supervising authority shall if satisfied that there is no objection to registration, register the applicant in respect of a nursing home and issue to him/her a certificate of registration in Form 'C' If, after enquiry and giving opportunity of being heard to the applicant and having regard to the advice of the competent authority, the authority is satisfied that the applicant has not complied with the requirements of the Act and these rules, it shall for the reasons to be recorded in writing, reject the application for registration and communicate such rejection to the applicant as specified in particular form. |
No Changes The involvement of the competent authority needs to be there when rejecting any applications, since this law is stakeholder friendly. A reasonable rectification period of say a month be given to the clinical establishment to make-up for the deficiencies pointed out in the LSA's report. This would be followed by reapplication by the doctor, reinspection by the Competent Authority before a final decision is taken by the Competent Authority. Such a provision is necessary as registration may be denied, sighting even minor deficiencies. Such reminder notice is necessary if the regulatory process is to be doctor friendly also, in addition to being consumer-friendly. |
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Rule Section 6 (1973) : |
Renewal of registration – An application for the renewal of registration shall be made every year in advance in Form 'B' in the month of January, and shall be accompanied by the fee prescribed in sub-rule of rule 7. |
An application for the renewal of registration shall be made every three years, three months in advance in specified Form and shall be accompanied by the fee prescribed in sub-rule of rule 7. Incase of late submission for renewal a grace period of 1 month would be considered with a late fee by the competent authority. |
This is providing for those who submit late. |
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Rule Section 8 (1973) |
Transfer of ownership etc. of nursing home – The transfer of the ownership or management of nursing home the transferor and the transferee shall jointly communicate the transfer effected to the local supervising authority and the transferee shall make an application for registration in accordance with the provisions of rule 4 |
The transfer of the ownership or management of clinical establishment the transferor and the transferee shall jointly communicate the transfer effected to the local supervising authority and the transferee shall make an application for registration in accordance with the provisions of rule 4 In case the establishment ceases to function as a clinical establishment, the certificate of registration shall be surrendered to the local supervisory authority. |
Only changes in the term nursing homes to clinical establishment To follow the due process, it is imperative for the those to inform the local supervisory authority to cancel the registration and also protect the owner of the clinical establishment |
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Rule Section 9 (1973) |
Change of address – A person registered under the Act in respect of a nursing home shall communicate to the local supervising authority any change in his address or in the situation of the nursing home in respect of which he is registered not later that seventy-two hours after such change. |
'and or status' – A person registered under the Act in respect of a clinical establishment shall communicate to the local supervising authority any change in his address or in the situation of the clinical establishment in respect of which he is registered not later than seventy-two hours after such change. Further in case the status of the clinical establishment changes in any manner (increase / decrease in size, facilities etc. ) from the time of registration shall inform the local supervisory authority and pay the required fees or apply for refund. |
Only changes in the term nursing homes to clinical establishment. A need for this provision since the size may increase / decrease from the time of registration to renewal and need to pay appropriate amount There should be a week's period to communicate this change to the authorities. Small establishments do not have separate human power to look after such administrative matters. No harm would be done to the interests of the patients or to the larger public interest, if this period is extended to a week. |
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Rule Section 10 (1973) |
Change in staff – Any change in the medical, nursing or midwifery staff together with the dates on which such changes has taken place shall be communicated to the local supervising authority immediately and in any case, not later than three days of such change. |
To be deleted |
Due to the turnover of staff it is quite impractical for clinical establishments to follow this and the information is not so useful. |
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Rule Section 11 (1973) |
Lost certificate – In the event of certificate of registration being or destroyed, the holder may apply to the local supervising authority for a fresh certificate and the local supervising authority may, if it thinks fit, issue such certificate upon payment of a fee of Rs. 5 A certificate issued under this rule shall be marked “Duplicate” |
In the event of a certificate of registration being lost or destroyed, the holder may apply to the supervising authority for issue of a duplicate certificate of registration and the supervising authority, if it thinks fit, issue such certificate and / or upon payment of a fee of Rs. 100. A certificate of registration issued under this rule shall be marked 'Duplicate'. . |
The amount of Rs. 5 is very low, it will not even cover the costs of paper. |
Penalty for non-registration
Section 6
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Existing provision |
Proposed changes / Incorporation |
Rationale for changes |
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Whosoever contravenes the provisions of section 3, shall, on conviction, be punished with fine which may extend to five hundred rupees or, in the case of a second or subsequent offence, with imprisonment for a term which may extend to three months or with fine which may extend to five hundred rupees or with both. |
Whosoever contravenes the provisions of section 3, shall on conviction for a first offence (non-registration) be punishable with a fine of ten thousand rupees or and with imprisonment for a termwhich may extend to 2 years, in the case of a second or subsequent offence (non-registration) with imprisonment for a term which may extend to (four years or with fine which may extend to twenty thousand rupees) or with both and shall in addition be liable to a fine which may extend to five hundred rupees for everyday) for which the offences continues after conviction. . |
To provide for deterrence for those not registering and also identify bogus clinical establishment and take action. * Need to check with the law and judiciary dept. As provided in the existing BNHRA, imprisonment of up to three months should be there only for second and subsequent offence. This makes a clear distinction between failure of registration and evading of registration and hence this clause would be directed only against bogus doctors and criminals. |
Cancellation of Registration to run the establishment
Section 7
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Existing provision |
Proposed changes / Incorporation |
Rationale for changes |
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Subject to the provisions of this Act, the local supervising authority may at any time cancel the registration of a person in respect of any nursing home on any ground which would entitle it to refuse an application for registration of that person in respect of that home, or on the ground that the person has been convicted of an offence under this Act or that any other person has been convicted of such an offence in respect of that same. |
If at any time after any person has been registered in respect of any clinical establishment and granted a license therefore, the local supervisory authority is satisfied that the terms of license are not being complied with, may cancel such registration and license: Provided that no cancellation of any registration and license shall be made unless such person has been given an opportunity of explaining (within fifteen days from the date of receipt of a notice in this behalf) as to why such registration and license should not be cancelled. |
In case the clinical establishment does any unlawful/illegal activity, need for local supervisory authority to take action after due hearing. This section should include the following: The competent authority must give written order with reasons for cancellation of registration. |
Notice of refusal or of cancellation
of registration
Section 8
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Existing provision |
Proposed changes / Incorporation |
Rationale for changes |
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1 |
Before making an order refusing an application for registration or an order canceling any registration, the local supervising authority shall give to the applicant or to the person registered, as the case may be, not less than one calendar month's notice of its intention to make such an order, and every such notice shall state the grounds on which the local supervising authority intends to make the order and shall contain an intimation that if within a calendar month after the receipt of the notice the applicant or person registered informs the authority in writing that he desires so to do, the local supervising authority shall, before making the order, give him/her (in person or by a representative) an opportunity of showing cause why the order should not be made. |
If the authority is satisfied that the clinical establishment has violated or has contravened any of the provisions of this act or the rules or By-laws, the local authority/competent authority may order cancellation or suspension of the registration for such period as it may think fit and on such cancellation the certificate of registration shall stand withdrawn; provided that before a clinical establishment is cancelled it shall be given an opportunity to be heard. |
In case the clinical establishment does any unlawful/illegal activity, need for local supervisory authority to take action after due hearing. |
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2 |
If the local supervising authority, after giving the applicant or the person registered an opportunity of showing cause as aforesaid, decides to refuse the application for registration, as the case may be, it shall make an order to that effect and shall send a copy of the order by registered post to the applicant or the person registered. |
If the local supervising authority/competent authority, after giving the applicant or the person registered an opportunity of showing cause as aforesaid, decides to refuse the application for registration, as the case may be, it shall make an order to that effect and shall send a copy of the order by registered post to the applicant or the person registered. |
In case the clinical establishment does any unlawful/illegal activity, need for local supervisory authority and competent authority to take action after due hearing. |
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3 |
Any person aggrieved by an order refusing an application for registration or canceling any registration may, within a calendar month after the date on which the copy of the order was sent to him, appeal to the government on any such appeal shall be final. |
Any person aggrieved by an order refusing an application for registration or canceling any registration may, within a calendar month ( 30 days) after the date on which the copy of the order was sent to him/her, appeal to the clinical establishment board on any such appeal shall be final. Further any person aggrieved by the functioning of the local supervisory authority and or the competent authority may make a written complaint to the clinical establishment board. |
This is to make the local supervisory authority and competent authority accountable. The appeal against the order of any body under this act should be heard by a Ombudsman-who could be a retired High court judge who will constitute an appellate authority and also serve as grievance redressal authority. Since the various authorities /boards created under the act are part of decision making process for rejection of application for registration, can they can not hear appeal against their own orders. There should be a provision to appeal to the health secretary or such high level health bureaucrat in case the ombudsman is on leave or non-functional for any reason. Otherwise appeals may not be heard for months together. |
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4 |
No such order shall come into force until after the expiration of a calendar month from the date on which it was made or, where notice of appeal is given against it, until the appeal has been decided or withdrawn. |
No such order shall come into force until after the expiration of a calendar month (30 days) from the date on which it was made or, where notice of appeal is given against it, until the appeal has been decided or withdrawn. |
No changes |
Inspection of Nursing home
Section 9
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Existing provision |
Proposed changes / Incorporation |
Rationale for changes |
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The health Officer of the local supervising authority or the Civil Surgeon of the district in which a nursing home is situated or any other officer duly authorized by the local supervising authority or the Civil Surgeon, may, subject to such general or special orders as may be made by the local supervising authority at all reasonable times enter and inspect any premises which are used, or which that officer has reasonable cause to believe to be used, for the purpose of nursing home, and inspect any records required to be kept in accordance with the provisions of this Act.: Provided that nothing in this Act shall be deemed to authorize any such officer to inspect any medical record relating to any patient in a nursing home. |
Every clinical establishment shall afford reasonable facilities for inspection of the place, equipment and records to the local supervisory authority or the competent authority or any other officer duly authorized by the local supervising authority or the competent authority may, subject to such general or special orders as may be made by the local supervising authority at all reasonable times enter and inspect any premises which are used, or which that officer has reasonable cause to believe to be used, for the purpose of clinical establishment and inspect any records, register, document, record, equipment and article as he may deem necessary for the purpose of the provision of the act. Provided that nothing in this Act shall be deemed to authorize any such officer to inspect any medical record relating to any patient in a clinical establishment. |
In case it is brought to the knowledge of the local supervisory authority or competent authority that illegal, unlawful and malpractice is going on in the clinical establishment. Any person not below the rank of Tehsildar --- and should have technical/medical expertise relevant/similar to the clinical establishment to be inspected. The inspection will be done at the time of original registration and/or at time of renewal/and/or if the nature of the work is being changed. Such routine inspection be done at a time which is unlikely to disturb /interfere with the treatment of the patient and/or doctors work. There should be a separate clause for surprise inspection. It should be clearly mentioned that non-routine/surprise inspection would be done only when there is a written complaint from a patient or a representative body of patients/citizens alleging non-compliance of the provision of the act. In case of specific complaint, the authority ordering inspection must record in writing the reasons for inspection. The procedure of inspection should be laid down. The decision to do unscheduled inspection should be taken by the appropriate authority jointly and should if necessary be by the method of voting if there is a difference of opinion. The dissenting members should have a right to record their dissent. .Frivilous /vexatious complaint should be made punishable with a fine of Rs.5000/- The decision regarding this should be entrusted to an Ombudsman |
|
|
If any person refuses to allow any such officer to enter or inspect any such premises as aforesaid, or to inspect any such records as aforesaid or obstructs any such officer in the execution of his powers under this section, he shall be guilty of an offence under this Act. |
If any person refuses to allow any such officer to enter or inspect any such premises as aforesaid, or to inspect any such records as aforesaid or obstructs any such officer in the execution of his powers under this section, he shall be guilty of an offence under this Act. |
No Changes The inspecting person should have a written order from appropriate authority with reasons mentioned for inspection. The stakeholder should have a right to get copies of the inspection report and if any records are seized reasons for seizure as well an official receipt should be given. |
Income of Local Supervising Authority
Section 10
|
|
Existing provision |
Proposed changes / Incorporation |
Rationale for changes |
|
|
Any fees received under this Act shall be paid into the fund of the local supervising authority |
Any fees received under this Act shall be paid into the fund of the local supervising authority for the implementation of this act. |
The fees collected should not be put in the government treasury but be utilized for the implementation of this act. |
Section 11
|
|
Existing provision |
Proposed changes / Incorporation |
Rationale for changes |
|
|
Notwithstanding anything contained in any enactment in regard to any municipal or local fund, all expenses incurred by a local supervising authority under and for the purposes of this Act and the rules and by-law may be paid out of the municipal or local fund, as the case may be. |
Notwithstanding anything contained in any enactment in regard to any municipal or local fund, all expenses incurred by a local supervising authority and or competent authority under and for the purposes of this Act and the rules and by-law may be paid out of the municipal or local fund, as the case may be. |
Though the fees should be used for implementing the provision of the act, there would be some areas, districts the fees may not be sufficient. The government should provide the same. |
|
Rule Section 7 (1976) |
Fees for registration and renewal of registration:- The fees to be paid for registration shall be charged as under:- a) Rs. 50 in respect of a nursing home having not more than 10 beds; b) Rs. 100 in respect of a nursing home having more than 10 beds. The fees for the renewal of registration, shall in each case, be equal of the amount payable for the first registration. |
Kindly see accompanying table in annexure 1 |
The amount charged in the existing is very meager and does
not even cover the administrative cost of registration. The fees collected to
be used for implementation. The supreme court has, in one important
judgment ruled that any registration fee has to be nominal. However, the |
Penalty for offences under Act
Section 12
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|
Existing provision |
Proposed changes / Incorporation |
Rationale for changes |
|
|
Whoever contravenes any of the provisions of this Act or of any rule shall, if no other penalty is elsewhere provided in this Act or the rules for such contravening, on conviction be punished with fine which may extend to fifty rupees and in the case of a continuing offence to a further fine of fifteen rupees in respect of each day on which the offence continues after such conviction. |
Whoever contravenes any of the provisions of this Act or of any rule shall, if no other penalty is elsewhere provided in this Act or the rules for such contravening, on conviction be punished with fine which may extend to 5000 rupees and in the case of a continuing offence to a further fine of 50 rupees in respect of each day on which the offence continues after such conviction. |
To act as a deterrent. Need to check with the Law and judiciary Dept Daily fine has been provided in the existing BNHRA. The proposal is to hike it to Rs.50 per day. This is OK. |
Offences by Corporations
Section 13
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Existing provision |
Proposed changes / Incorporation |
Rationale for changes |
|
|
Where a person committing an offence under this act is a company or other body corporate or an association of persons (whether incorporated or not), every person who at the time of the commission of the offence was a director, manager, secretary, agent or other officer or person concerned with the management thereof shall, unless he proves that the offence was committed without his knowledge or consent be deemed to be guilty of such offence. |
Where a person committing an offence under this act is a company or other body corporate, include government and or an association of persons (whether incorporated or not), every person who at the time of the commission of the offence was a director, manager, secretary, agent or other officer or person specified in the registration form and concerned with the management thereof shall, unless he proves that the offence was committed without his knowledge or consent be deemed to be guilty of such offence. |
Included government and have been specific in relation to the one on whose name the registration form is filled. |
Court competent to try offences
under Act
Section 14
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Existing provision |
Proposed changes / Incorporation |
Rationale for changes |
|
|
No court other than that of a Presidency Magistrate or a Magistrate of the first class shall take cognizance of or try any offence under this Act. |
No court other than that of a Presidency Magistrate or a Magistrate of the first class shall take cognizance of or try any offence under this Act. |
No Changes |
Indemnity to persons acting under this Act
Section 15
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Existing provision |
Proposed changes / Incorporation |
Rationale for changes |
|
|
No suit, prosecution or other legal proceeding shall be instituted against any person for anything which is in good faith done or intended to be done under this Act, rules or By-law's. |
No suit, prosecution or other legal proceeding shall be instituted against any person for anything which is in good faith done or intended to be done under this Act, rules or By-law's. |
No Changes Total immunity is not desirable in such a social legislation. The various boards/authorities should be accountable. |
Rules
Section 16
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|
Existing provision |
Proposed changes / Incorporation |
Rationale for changes |
|
1 |
The state government may by notification in the official Gazette make rules to carry out all or any of the purposes of this Act. |
The state government may by notification in the official Gazette make rules to carry out all or any of the purposes of this Act. |
No Changes |
|
2 |
Without prejudice to the generality of the foregoing provisions such rules may prescribe- a) the form of the application to be made under section 4 b) the date on which an application for registration or renewal of registration to be made and the fees to be paid for such registration or renewal of registration c) the form of the certificate of registration to be issued under section 5 d) for any other matter for which no provision has been made in this Act, and for which provision is, in the opinion of the provincial Government necessary. |
Without prejudice to the generality of the foregoing provisions such rules may prescribe- a) the form of the application to be made under section 4 b) the date on which an application for registration or renewal of registration to be made and the fees to be paid for such registration or renewal of registration c) the form of the certificate of registration to be issued under section 5 d) for any other matter for which no provision has been made in this Act, and for which provision is, in the opinion of the provincial Government necessary. - The principle and criteria for granting registration for a clinical establishment; - The terms and conditions of a registration; - To prescribe minimum requirements for various types of clinical establishment - The form of application for a registration of a clinical establishment - The form of the periodical returns and statistics to be submitted by the clinical establishment to the authority - The mode of holding meetings and the conduct of business by the authority; The state government through the clinical establishment registration board may by notification constitute, in such manner as maybe prescribed, committee/s to advice the state government on the implementation of the provision of this act The clinical establishment registration board may, if it considers necessary, for dealing with any special issue before it, invite any person's (s) to attend any meeting but such person shall not be deemed to be a member of the authority, nor shall he have a voting right |
No Changes The clinical establishment board cannot by itself make standards. Making standards is a specialised job. The board would establish committees to harness expertise in specialised branches of medicine. |
|
3 |
The power to make rules under this section shall be subject to the condition of previous publication in the official Gazette. |
. |
No Changes |
By-law's
Section 17
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|
Existing provision |
Proposed changes / Incorporation |
Rationale for changes |
|
1 |
The local supervising authority may make by-laws not inconsistent with this Act or rules - (a) prescribing the records to be kept of the patients received into a nursing home, and in the case of the maternity home, of miscarriages, abortions or still births occurring in the nursing home and of the children born therein and of the children so born who are removed from the home otherwise than to the custody or care of any parent, guardian or relative. (b) requiring notification to be given of any death occurring in the nursing home. |
The local supervising authority may make by-laws not inconsistent with this Act or rules - a) prescribing the records to be kept of the patients received into a clinical establishment, and in the case of the maternity home, of miscarriages, abortions or still births occurring in the nursing home and of the children born therein and of the children so born who are removed from the home otherwise than to the custody or care of any parent, guardian or relative. b) requiring notification to be given of any death occurring in the clinical establishment. |
No Changes |
|
2 |
Any by-laws made by a local supervising authority under this Act may provide that a contravention thereof shall be punishable - a) with fine which may extend to fifty rupees; or b) with fine which may extend to fifty rupees and in the case of a continuing contravention, with an additional fine which may extend to fifteen rupees for every day during which such contravention continues after conviction for the first such contravention; or c) with fine which may extend to fifteen rupees for everyday during which the contravention continues after the receipt of a notice from the local supervising authority by the person contravening the by-law requiring such person to discontinue such contravention. |
Any by-laws made by a local supervising authority under this Act may provide that a contravention thereof shall be punishable - a) with fine which may extend to five thousand rupees; or b) with fine which may extend to fifty rupees and in the case of a continuing contravention, with an additional fine which may extend to fifty rupees for every day during which such contravention continues after conviction for the first such contravention; or c) with fine which may extend to fifty rupees for everyday during which the contravention continues after the receipt of a notice from the local supervising authority by the person contravening the by-law requiring such person to discontinue such contravention. |
As a deterrent |
|
3 |
No By-law made by the local supervising authority shall come into force until it has been confirmed by the state Government with or without modification. |
No By-law made by the local supervising authority shall come into force until it has been confirmed by the state Government or the body entrusted by the state government with or without modification. |
No Changes |
|
4 |
All by-laws made under this section shall be published in the official Gazette. |
All by-laws made under this section shall be published in the official Gazette. |
No Changes |
Saving
Section 18
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|
Existing provision |
Proposed changes / Incorporation |
Rationale for changes |
|
|
Nothing in this Act shall apply to - i) any nursing home carried on by Government or a local authority or by any other body of persons approved by the state Government in this behalf; and ii) any asylum for lunatics or patients suffering from mental diseases, within the meaning of the Indian Lunacy Act, 1912. |
Nothing in this Act shall apply to any asylum for lunatics or patients suffering from mental diseases, within the meaning of the Mental Health Act, 1987 The government run clinical establishments will be excluded from paying the registration fees |
The government should provide funds for implementation where the number of clinical establishments are very few and there may not be sufficient money collected as registration fees. The government insitution should also pay the registration fees and other charges as applicable especially when the fees collected will be used for implementation and enforcement of the act. |
New Suggestions / Incorporations In The Present Act / Rules
Furnishing of information
Every clinical establishment shall, within such time or
within such extended time as may be fixed by the clinical establishment
registration board in this behalf, furnish to the competent authority such
returns, statistics and other information as the clinical establishment
registration board may from time to time require.
Immediate report about notifiable diseases- The
keeper of the clinical establishment shall submit a report immediately, to
local supervisory authority as soon as it comes to his/her notice that any
person who has been admitted or examined as a indoor or out-door patient in the
clinical establishment is suffering from or has been attacked with a contagious
diseases. A format for filing such reports should be provided to establishments
at the time of registration. In case an establishment does not file reports,
the renewal of it's registration may be withheld or
other penalty may be imposed.
There is already the provision in the notifiable
diseases act. There should not be duplication of the acts.
The records of reports of all investigations conducted, diagnosis etc.
should be provided to the patient on discharge. Provision of discharge slip to
all patients should be routine and mandatory. However copies of detailed case
records, indoor record sheets and reports of investigations could be made
available on written request and on payment of photocopying charges.
This section mentions that it is obligatory on the part of the
clinical establishment to inform the nearest police station about all
suspicious cases or injuries and all medico legal cases. There is no need for
this section. It is a settled law that a doctor or any citizen who has
knowledge of any crime must inform the police. It has also been held by the
Also after
the judgement of Supreme Court in Parmanand
Katara v/s
Constitution of the competent authority and apex body
Competent Authority means “the committee constituted under this act to assist the
local supervisory authority in discharging the functions under this act. It
shall include the collector of the district or his / her representative or
Commissioner in case of municipal corporation or his / her representative, head
of the local supervisory authority, 1 professor or lecturer from nearest
medical college, one representative from the hospital owners association, one
representative from the laboratory owners association, one representative from
the homeopathy association, one representative from the Indian system of
medicine association, one representative from a government clinicall
establishment, one representative from the local consumer organization and non
governmental organization working in the area of health and one women's'
organization and one representative of insurance companies. (Representatives
from consumers organisation, NGO working in the area
of health and women's' organisation can be selected
by consensus in a meeting of such organisations
convened by the Collector / Commissioner).
A representative from the Indian Medical Association be
included as the IMA is the largest, oldest body of medical professionals.
· The term of the competent authority
would be for a period of 5 years.
· The collector / commissioner would
be the chairperson of the authority.
· The head of the local supervisory
authority would be the member secretary.
· A chairperson would be elected from
amongst themselves
· The quorum for any meeting shall be
four, including the chairperson.
· The committee would meet at least
once in two months to transact the business.
· The competent authority shall also
act as a grievance redressal forum regarding
provisions stipulated under this act where it would entertain
complaints from patients, consumers, and lay public among others.
Without derogation to any law for the time being in and without prejudice to
the generality of its power functions of the authority shall be
(a) Receive applications for
grant of registration to clinical establishment
(b) Scrutinize the applications and call for further information or particulars
from the applicants or from any other persons or authority as may be required;
(c) Consider the applications
and pass orders; and
(d) Do such other things as are
necessary or incidental for the purposes of this act
Not withstanding anything contained in this act, the state government may at
any time reconstitute the competent authority if it finds its functioning
unsatisfactory.
The power of the governmentto
reconstitute competent authority should be with qualification. If the competent
authority needs reconstitution then it is the right of the stake holders who
are paying registration fees and the consumers to know the reasons. It should
be mandatory on the government to disclose the details/reasons of
reconstitution.
The authorities under this act should be fully accountable. All the
stake holders, registered establishments, consumers should have complete access
to the information. The chairman of the local supervisory council/competent
authority/clinical establishment board should be made responsible for ensuring
the transparency of the functioning of these authorities and access to
information. The various authorities under this act must publish annually all
the details about the number of registrations,number of complaints and the outcome of complaints.
This record should be available electronically also.
Clinical Establishment Registration Board: This board is set up under the
act to be an apex body for the implementation of the act, lay down minimum
requirements (standards) or upgrade existing requirements periodically (every 5
years) for different types of clinical establishments, appropriate number of
types of clinical establishments in a geographical area and suggest revision of
fees charged periodically (every 5 years).
The board would consist of Secretary Public Health department, Secretary
medical education department, Secretary urban development department, Director
general of health services would be the member secretary, 2 joint directors, 1
representative from the state Indian Medical Association, 1 representative from
the Homeopathy association, 1 representative from the Indian system
association, 1 representative from the laboratories association, 1
representative from the hospital owners association, 1 representative from the
dental association 1 representative each from two state level consumer
organization and 1 representative from a non government organization working in
the area of health and 1 representative from a State –level womens' organization.
The government would strive and provide information under this act to the
general public or any other body information related to the functioning and
findings of the local supervisory authority, competent authority and clinical
establishment registration board.
Minimum Requirements of Clinical
Establishment
Every clinical
establishment shall fulfill and conform at all times to the requirements
(standards) framed from time to time as per the provision in the Act, rules and
By-laws. These standard may apply to the structure
(staff, building, space requirements, equipment or other facilities), the
process (what services and how the services are provided) and the outcome
(results). The clinical establishment registration board so constituted by the
government under this act shall lay down standards.
The clinical establishment board should appoint committees consisting of
experts from relevant sections of medical professionals and one representative
of consumer/health NGO to decide diagnostic and therapeutic protocols for
common clinical situations to start with. There protocols would be based on
consensus protocols already available nationally, internationally, to be
modified suitably for Indian conditions.We would not
be able to monitor medical practice on the basis of these protocols, but these
protocols would be used as reference standards in case of any allegations about
alleged substandard care.
, A beginning can
be made with simple measures like giving a copy of the case-paper to patients,
giving adequate information to the patients etc.
Standards for outcomes are much more
difficult to agree upon and monitor. Hence this needs to be deleted today.
It is necessary to include in the act that the clinical establishment board
will constitute various expert groups and finalise
the standards. These standards should be published and should be available for
every consumer. Also the clinical establishment should clearly display the
grade for which it has been registered. The act should also include provision
for upgradation and review of standards periodically.
Having a qualified midwife in any maternity home is an ideal scenario. But it
has not been taken in to account that many of the infrastructural facilities
are inadequate.For example enough no. of qualified
nurses are not available.Therefore the minimum
requirement need to be qualified with words to the effects: “Whereever qualified staff is not avalable,trained staff should be allowed”It
also necessary to amend the relevent parallel acts
like Maharastra Nursing Council Act to improve the
situation
Obligations of Clinical Establishment
Every
clinical establishment shall
o
Administer
necessary first aid and take other life saving or stabilising
emergency measures appropriate for that grade of establishment in
medico-legal or potentially medico-legal cases such as victims of road
accidents, accidental or induced burns or poisoning or criminal assaults and
the like which present themselves at the establishment.
There are nursing homes which conduct only minor day-surgeries like opthalmic or ENT. There is no doctor available after the
surgeon has left, since generally this is not needed. Such set-ups can not
cater to any general medical or accident emergency even to provide life saving support . So only hospitals should have
this obligation.
However, even the nursing saff in all clinical
establishments should be trained to give life saving first aid consisting of
clearing of the airway, mouth to mouth breathing, external cardiac message,
starting an IV line, arresting external bleeding by pressure bandage, proper
positioning of the unconscious patient.
· In times of epidemics or disasters the government may
call upon clinical establishments to provide services.
· Actively participate in the implementation
of all national and State health programmes in such
manner as the State Government may reasonably specify from time to time , and
to furnish periodical reports thereon to the concerned authorities.
The suggested changes include active implementation of national health programmes by the registered establishment It is necessary
to substitute this formulation with the following --. ”All the private clinical
establishments will follow the mandatory therapeutic guidelines for diseases
covered under various national health programmes and
as declared by the state and central government from time to time, and to
co-operate with the state health authorities for implementing National Health Programmes.”
The
clinical establishment shall not refuse admission or treatment)
of any patient on the grounds that s/he has human immunodeficiency virus (HIV)
infection. Refusal to entertain any patient who also has HIV infection
should not be allowed. But we it can not be made obligatory that all doctors
must treat all patients for HIV disease, as this treatment is many a
times a specialist job which not every doctor would be able to handle competently.The government with the help of concerned
experts in the field including those in NGOs, should prepare Standard
Orientation courses about care of HIV positive patients, for different types of
medical care workers ranging from doctors to attendants. It would include basics
of HIV, AIDS including its social aspects, about Universal Precautions, and the
duty of doctors, and other medical professionals towards HIV positive patients.
This course should be aimed at dispelling the excessive scare of medical
workers getting HIV infection from HIV positive patients. This course be publicly funded. Half the funds can come from the service
charges collected from MEs under the MME Act. The
All medical workers must register themselves to undergo this course within a
year of the enactment of MEA. As soon as all the staff any
M.E. have completed this course, it shall certainly execute the policy that
there shall not be any discrimination against any HIV positive patients.
After two years no ME shall employ any person as medical staff who has not undergone this certificate course.
Engaging Government servant
The
keeper or owner of the clinical establishment shall not engage any government
servant for any work including consultation without express permission of the
Government obtained by such a government servants in this behalf and in the
event of engagement of any government servant in the clinical establishment,
the keeper or owner thereof shall furnish to the supervising authority details
of engagement of such government servant or full time/part time basis along
with the emoluments paid to him/her by the clinical establishment. . The
responsibility for informing the clinical establishment about being in
government service and taking the permission of the government to work in the
clinical establishment should rest with the employee and not with the employer.
Display of fees, costs and rates for
various services
Every
clinical establishment should arrange display of the fees, costs and rates of
all kind of services in order to maintain due transparency.
Power to remove difficulties
If
any difficulty arise in giving effect to the provisions of this act or in the
interpretation of any of its provisions the state government may within the
ambit of the act, by order remove the difficulty or interpret the provision and
such order shall be final and binding.
Miscellaneous
Any
person who knowingly serves in a clinical establishment which is not duly
registered and licensed under this Act or which is used for unsocial or immoral
purposes, shall be punishable with fine which may extend to five hundred rupees
If somebody knowingly works in a MANEGERIAL CAPACITY in an unregistered,
i.e. illegal medical establishment, such a person may be fined with a fine of upto Rs. 500.
Not withstanding any provision, the clinical establishment shall follow all
applicable rules e.g. Waste management, drugs and medicines, employees,
building safety norms etc.
***************
Annexure I
Fees Charged
|
|
Rural |
Urban |
Metropolitan |
|
Hospitals, Nursing Homes, Maternity home, any Health Centres upto 10 beds |
1500 |
2250 |
3000 |
|
Hospitals, |
2500 |
3750 |
5000 |
|
Hospitals, |
5000 |
7500 |
10000 |
|
For each additional bed above 100 beds |
20 |
30 |
40 |
|
Clinical laboratories / Diagnostic center X-ray Centres and/ or Ultra Sonogram Scan Centre |
2500 |
3500 |
5000 |
|
Imaging centers, C.T. Scan Centres and / or MRI Scan Centres |
10000 |
15000 |
20000 |
|
Physiotherapy Centres |
2000 |
3000 |
4000 |
Note: Wherever a
clinical establishment / hospital is offering additional ancillary facilities
mentioned above eg. laboratory, X-ray, CT scan etc.
within the same set-up, the registration / renewal fee for the ancillary
facility would be 50% of the fee for a stand- alone establishment.
The figures in the table above will have to be changed. The service fee
will have to be worked out on the basis of the cost of the regulatory service
being provided by the govt.
Annexure II
DEFINITIONS
Clinical establishment: any premises used or intended to be used, for the
reception/counseling/ treatment/
therapy/ surgery/ physical correction/ manipulation of persons suffering from any
sickness, injury or infirmity and the providing of treatment and nursing for
them.
Day care centers : Which conduct only minor 'office
procedures' like ophthalmic or certain ENT minor surgeries.. There is no doctor
available after the surgeon has left, since generally this is not needed
Maternity home: ( permitted only in non-metro area) : where patients
maybe admitted for normal delivery and in case of emergency patient maybe
shifted to NH or hospital for surgery.
Nursing Home: a clinical establishment with facilities for
in-patient stay at night also, but no casualty facilities and limited speciality facilities and limited emergency facilities for
non-indoor patients.
Hospitals: Nursing Home plus comprehensive round the clock emergency and trauma
facilities with multi-specialty emergency facilities.
ICUs: facilities for 24 hour intensive management with advanced life support
systems and availability of 24 hour post-graduate medical specialists of
respective fields. Eg general ICU, PICU, NICU, ICCU.
**************
BEYOND LAW AND THE
LORD
Quality of Private Health Care
Sunil Nandraj
Although the private sector in health care is large and growing, it is poorly
regulated with hardly any regard to quality of care.
The World Bank paper on 'Health Financing in
The private health sector is a large and important constituent in the country's
health care delivery system. The share of the private health sector in
EXTENT OF PRIVATE PRACTICE
Data on sectoral distribution of doctors is not
easily available because many states do not file that required information in
the ministry of health. A study conducted in 1963-64 by the
Practitioners also consist of those having dubious qualifications and degrees
or having no qualifications at all such as those who have worked as helpers, compounders or assistants for other doctors for a period of
time and have picked up the skill in the process. In this category sometimes
spouses of doctors are also included, who sit in the clinic when the doctor is
away. Also included in certain cases are the sons/daughters who 'inherit' the
practice of their parents. A study conducted in Madhya Pradesh showed that of
all those treated by private facility, 52.24 per cent of the illness episodes
in rural, 17.83 per cent in urban areas were treated by licentiates/RMPs (George, Shah and Nandraj
1993). The extent of quackery can be gauged from the advertisements which
appear regularly in leading newspapers of the country for cure of various
illnesses. The decay has set in so much that posters are displayed openly at
local railway stations of
In
The above data suggests that the size of private hospitals is much larger than
official data brought out by the government. Secondly that indoor care provided
by private hospitals is much larger than public hospitals and this growth has
taken place mainly in urban areas. The increase has occurred not so much
because private hospitals are better equipped, more efficient and manned by
better qualified and more humane staff as because public hospitals have simply
failed to keep pace with the demand, have been starved of funds, are neglected
and run down.
A recent development in private health sector has been the growth of corporate
hospital, rightly termed 'Medical Industrial Complex' (Relman
1988). In 1983, the first corporate hospital in
Most of the big corporate and trust hospitals are concentrated in metropolitan
cities. Many of them use the facade of register themselves as trust hospitals
with a view to getting various benefits from the state and escape various
taxes.
QUALITY OF PRIVATE CARE
Only recently attention has been focused on the serious anomalies with regard
to the functioning and quality of care being provided by private practitioners.
This was possible because a number of cases of medical malpractice and
negligence filed in the court of law by the victims and their relatives as well
as due to role-played by the media and different consumer organisations.
For specialised treatment like hospitalisation
and investigations, the GP would refer the patient elsewhere. Informal
discussions and meetings with private doctors revealed that in metropolitan
cities like
The technical/medical knowledge of the doctors regarding treatment being
provided to the people needs to be examined. Two studies on knowledge and
awareness among doctors regarding tuberculosis and leprosy were conducted in
Further, preliminary results of a study being conducted in a typical district
of Maharashtra found that unnecessary use of
injections, irrational drug combinations, hazardous drugs and unnecessary drugs
were prescribed more in the private sector. Out of a total of 633 prescriptions
analyzed from 27 private clinics it was found that 28.9 per cent were of
irrational drug combinations, 9.6 per cent were for hazardous drugs, 45.7 per
cent were unnecessary drugs and 26.5 per cent were unnecessary injections.
Compared to 591 prescriptions from 17 public clinics, it was found that 2 per
cent were irrational drug combinations, 0.5 per cent were for hazardous drugs,
28.4% were for unnecessary drugs and 24.2 per cent per cent were for
unnecessary injections (FRCH (b)1993). The main source of
continuing education for doctors are the medical representatives.
Medical representatives of the pharmaceutical industry, including those from
the renowned multi-nationals, in their race for fulfilling targets approach
those not having proper or dubious qualifications. In this manner, they also
encourage quackery.
The Time spent on the patient for diagnosing and explaining would depend on the
load of patients, the doctor has per day/hour and or demand for the services. A
public opinion study conducted by Medico Friend Circle showed that out of 208
respondents 61 per cent of them felt that the waiting period to see a doctor
was highly unreasonable : that is, beyond 20 minutes (MFC, Bombay Group, 1993).
Besides many of the doctors while dispensing medicines and injections or
recommending investigations, do not provide information to the patient
regarding the diagnosis and side effects. In fact, many of them get angry when
questioned about the side effects of the drugs prescribed, the investigative
procedures recommended or regarding the diagnosis. The MFC study found that 41
per cent of the doctors did not give information about the diagnosis and among
those who gave information only half gave complete information. Only 16 per
cent of the respondents were given information on side eggects
of drugs. About 48 per cent of the respondents were completely satisfied with
the behavior of the doctors, 27 per cent partially and 17 per cent not at all.
Doctors' charges are more often than not exorbitant and irrational.The
charges levied are arbitrary, irrational and without any proper basis. The
question of fees and charges raises ethical issues, the important one being the
basis on which the price skills in a profession which is meant to be caring are
computed. There are no restrictions or guidelines for the fees charged by the
practitioners or consultants in the country. There is no standardization of
fees in the country. In the MFC study, in answer to the question regarding standardisation of fees charged by the doctor, it was found
that 65 per cent of them felt that there should be some form of standardisation of fees. The study also found that nearly
76 per cent of the doctors did not give a receipt for the payments made, only 24 per cent of them gave receipts after being
asked for it.
The earnings of doctors have been studied only recently. A study undertaken in
The fees of the doctors has grown apace with private
health care. The NCAER study showed that 55 per cent of the household
expenditure on health care was spent on private doctors and only 39per cent on
public institution. Many patients and their family members have been pauperized
during the course of treatment from the private health facilities.
Figures regarding cases treated, diagnosis, type of treatment provided, amount
charged etc. are not easily obtainable from private hospitals and nursing
homes. Only recently due to the demands made by the judiciary, various facts
have come out. In
In 1991 the Chief Justice of the Bombay High Court directed the Bombay
Municipal Corporation (BMC), to set up a permanent committee to oversee and
supervise the implementation of the Bombay Nursing Home Registration Act
(BNHRA), 1949, and make recommendations. This judgment came about due to a
public interest litigation filed by a victim's daughter and the activists of
MFC (MFC) (Bombay Group). In this case a homeopath doctor administered a wrong
blood type during transfusion to the patient in an allopathic hospital. The
case raised questions regarding standards of medical practice in private
hospitals and nursing homes, quality of staff employed and treatment offered
equipment used the general administration of these hospitals and their
accountability to the people at large. The case also further highlighted the
role of the implementation agencies.
The committee decided to look at the functioning of existing hospitals and
nursing homes in the city of
In
The study in
Private hospitals and nursing homes fall very short of the requirement.
Majority of them employ unqualified staff. In
Only 7 institutions employed qualified nurses and that too one nurse each. Most of them had employed unqualified nurses who
were either trained by doctor or had received training for about 3 to 6 months
from various private training institutes which have also sprung up to meet the
needs of private hospitals. These nurses are paid measly salaries and their
working conditions are pathetic. During informal discussions with the nurses it
was found that they were paid around RS 500 to Rs 700
per month in
The sanitary conditions of private hospitals and nursing
homes leaves a lot to be desired. The
The area surrounding the hospital plays an important role in the treatment of a
patient. During the study it was observed that one of the hospitals was
situated near a factory and the entire atmosphere was visibly polluted. Noise
emanating from the factory was well over prescribed limits. Many of the nursing
homes were found to be situated close to a busy traffic spot. Our findings with
regard to waste disposal were shocking. All the hospitals studied, disposed of
their waste in the common garbage dump. This form of disposal has serious
implications, because of the increased risk of spreading infectious diseases,
AIDS. Secondly, waste disposed thus may be recycled for further use as reports
from
The number of toilets and bathrooms were not in adequate proportion to the
number of beds provided in the hospital and also the area provided for such
facilities are very small. During visits to the hospitals in one of the
hospitals the blood stained linen was being washed in the common bathroom and
being dried in the passages. It was quite shocking to note that many of the
hospitals did not have continuous supply of water, and in some of them it was
being provided from outside through tankers and other means.
In the recent past care provided in private hospitals has come in for closer
examination. Private hospitals tend to perform unnecessary investigations,
tests, consultations and surgeries. Doctors in private hospitals more often do
not reveal the diagnosis and go on recommending tests to 'diagnose' the
ailment. Whereas in the public hospitals, doctors are
required to write the diagnosis on the case paper. Due to the fact that
the surgeries are 'profitable' many private hospitals are found to be
conducting unnecessary surgeries. The KSSP survey revealed that 31 per cent of
deliveries were by caesarean section. More significant 70 per cent of the
hospitals where caesareans were routine were privately owned (Kannan etal, 1991). In
The majority of private hospitals and nursing homes across the country are
generally refer patients who develop complications to
public hospitals so that they are not liable for cases of death. Most of these
hospitals refuse admission to accident cases and those cases involving medico
legal work, even when patients are in a very serious condition. Many
institutions refuse admission to patients, unless a certain amount of money is
not paid beforehand. Public hospitals in most cases do not refuse admission to
serious patients, if they have the facilities. In public hospitals one can
still demand services while in private hospitals they can turn patients at
their will.
Most private hospitals are run by 'medical entrepreneurs'. Many do not maintain
proper books of accounts. The charges are different for diverse kinds of
nursing homes. The charges include consultation fees and charges for bed,
nursing, operation, operation theater, various
investigations and disposables used, for medicines, etc. These charges are
levied by different entities - for instance the Doctor conducting the operation
would be different from the one who owns the nursing home, the anesthetists charges are again separate. We found that the
accounts in only one paediatric baby care nursing
were maintained properly. There it was found that the total gross income for
one month was Rs 2,20,000 (Nandraj 1992). A study undertaken in Delhi of the earnings
of the private practitioners and that of the ones running nursing homes with
graduate (MBBS) qualifications, their net income per month was Rs 73,650/ and the ones having post graduate degrees the
earnings were up to Rs 79,960.p.m. (Kansal 1992). In
Private hospitals are known to have an unhealthy nexus with the pharmaceutical
industry. 6 patients who had every chance of survival died in a prestigious
private hospital in
REGULATORY BODIES
The rules and regulation framed for practitioners
broadly fall under their respective State Council Acts for various systems of
medicine. The practitioners are also governed by the Drugs and Pharmaceutical
Act of 1950. Recently private practitioners and hospitals have been brought
under the purview of the Consumer Protection Act. Medical councils are
statutory bodies that set the standard of medical practice, 'discipline' the
profession, monitor their activities and check any malpractice. The certificate of registration issued by the council, which has to
be displayed in a conspicuous place in the place of practice. The
council has to maintain a register of the doctors and this has to be updated
regularly. Renewal of registration has to be made periodically. Those not
registered with the medical council cannot practice. Although the bulk of the
practitioners in the country are trained in other systems of medicine like
Homeopathy, Ayurveda, Unani,
Siddha, etc. most of them practice allopathy.
The medical councils regulating the conduct of doctors have failed in their
duties miserably. They have even failed in their basic duty of maintaining and
updating the register of doctors. This is reflected in the data brought out by
Health Information of India where many state medical councils
have not sent in the required information to the central government for years
together. In the Maharashtra Medical Council (MMC)
the register of doctors is outdated and full of errors. Secondly, there have
been very few instances of doctors being penalised
for negligence or violating the code of ethics. The enquiries are held in
secrecy. The Maharashtra Medical Council (MMC) was
unable to produce even a single record of action taken against erring doctors.
The medical councils in the country are in a mess. They have given permission
to private medical colleges which are substandard, understaffed, those not
meeting the minimum prescribed standards, like having their own hospitals etc.
and have failed to resist the pressure from politicians for opening of new
medical colleges.
The Recent elections to the MMC clearly brought out the way things are managed
in the council. Elections are held through the postal ballot method. The
registers of the council were not updated; so in a few instances ballot papers
were sent to doctors who had long expired. The names of doctors who had
registered with the council were not found in the register; doctors who were
indicted in the law courts and with dubious degrees were candidates in the
fray. There was massive rigging in the election process. A panel of doctors who
were in the fray paid money to the postal department and intercepted ballot
papers which were not meant for doctors who were absent or dead, etc and
stamped them. Blank ballot papers were collected in an organised
manner from doctors across the state and stamped. In an open forum some of the
doctors in fact endorsed this practice, saying that there was nothing wrong
with this procedure. Clearly, there is something seriously wrong. Politicians
doing the same thing would have been accused of fraud. Do doctors expect
patients to believe that a council elected in this manner is capable of
disciplining unscrupulous practitioners? [Pandya S
1993].
A study undertaken on behalf of the MFC (
The broad features of the BNHRA and DNHRA Acts are somewhat similar. The
objectives of these acts are to provide for registration and inspection of
nursing homes. The acts stipulate that every year the nursing home and hospitals
are required to make an application for registration or renewal for
registration to the local supervising authority, which could be the municipal
corporation, municipal body, district board, district panchayat
etc.During the time of application detailed information
should be provided in terms of qualification of staff, adequacy of staff,
sufficient and proper equipment, adequate accommodation facilities and space,
and regarding sanitary conditions. Maternity homes have to specify whether they
have got on their staff a qualified midwife. The Maharashtra
Act provides for the local authority to formulate bye-laws. On receipt of
application for registration the local authority may refuse to register the
application if any person employed in the nursing home is found unfit, weather
by reason of age or otherwise of it the nursing home or hospital is not under
the management of a qualified medical practitioner of a qualified nurse, or
does not have adequate space, equipment etc. Failure to register under the BNHRA
could mean a fine of Rs 500 for the first offence and
imprisonment for three months.
There are other regulations that are also applicable to hospitals and nursing
homes such as those referring to or related to buildings, drainage and sanitary
facilities; laws regarding Employees- Provident Fund, minimum wages, maternity,
working conditions among others. In addition to these hospitals registered, as
trusts or public societies have to follow the legislation formed for the trusts
and public societies. These laws make it essential to file returns periodically
to the appropriate authority.
During the proceedings of the public interest litigation it was found that the
municipal corporation, the authority for registration in the city of
The judges in the Bombay High court recognized the inadequacy of the existing
Act and also its poor implementation directed the Bombay Municipal Corporation
(BMC) to appoint an apex committee and three zonal committees to look into the
implementation of the act and make recommendations. The committees were
overwhelmingly filled with bureaucrats of BMC, who in the first place were
supposed to implement the act. Right from the inception bureaucrats in the
committees started placing obstacles in the committees functioning. And very
little progress has been made on the matter.
Corrective action needs to be taken to bring about reforms in this sector. As a
first step people should be made aware of their rights and duties vis-a-vis the health care system, specifically the private
health sector. There should be adequate representation of the people and
consumer organisations on the various regulating and
monitoring bodies functioning at various levels. Legislation should be enacted
where there is none legislation and the various existing legislations should be
implemented. The State should ban and take strong action against the private
practice of doctors employed in Government institutions. One of the main
reasons behind the non-functioning of the public health system is due to the
private practice of the Government doctors and other functionaries. With regard
to private practitioners, the state and medical councils should ensure that
only properly qualified person's practice. Through licensing and other means
the proper geographical distribution of practitioners and hospitals in the
country to prevent over-concentration in certain areas. There should be regular
medical and prescription audits and the renewal of license and registration
should be dependent on it. Records should be maintained properly and the
patients should have access as a matter of right. Minimum standards and
requirement for various types and kinds of hospitals and nursing homes should
be laid down. With regard to charges and fees there should be standardization
of fees charged by the practitioners and fixation of reasonable charges by
hospitals and nursing homes for the services provided. These should be displayed
prominently in a conspicuous place. There is a need for overhauling the medical
councils in the country. They should make provision for the registers to be
maintained properly and keep them open for public scrutiny. There should be
provision for continuing medical education on a periodic basis with renewal of
registration dependent on it.
NOTES
The support of friends and colleagues at MFC, CEHAT
and FRCH underlies this article, in particular the author has greatly benefited
from Ravi Duggal and Amar Jesani of CEHAT who have
encouraged me in carrying out the above mentioned studies. Thanks are also due
to Alex George for his helpful comments.
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