Regulation of Private Health Care Institutions

8/4/2019 Regulation of Private Health Care Institutions

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Laws and Regulations governingPrivate Health Care Establishment in

Karnataka, with special focus onKarnataka Private Medical

Establishment Act, 2007 and Rules,2009.

Regulation of Private Health CareInstitutions


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Medical/ Health CareEstablishments?

Medical establishments? a hospital or dispensary with beds or without beds, a Nursing Home, Clinical

Laboratory, Diagnostic Centre, Maternity Home, Blood Bank, RadiologicalCentre, Scanning Centre, Physiotherapy Centre, Clinic, Polyclinic,Consultation Centre and such other establishments by whatever name calledwhere investigation, diagnosis and preventive or curative or rehabilitativemedical treatment facilities are provided to the public

Classification within medical establishments Allopathic system of medicine Indian system of medicine Homeopathy system of medicine Diagnostic centers and Therapy establishments not attached to hospitals

Further classification of establishments concerned with allopathic system ofmedicine Consultation center Polyclinic Dental clinic Day care centers Nursing home (Bed capacity 1- 30, 31- 50, 51- 100)

Non- Teaching hospitals (Bed capacity 101- 500) Teaching hospitals


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What is to be understood as private?

Every medical establishment which is notrun orsponsored by

State/Central govt

PSU Co- operative societies owned or controlled by

State/Central Govt

Trust owned or managed by State/Central Govt or local

authority What about non- profitable or not for profit private

establishments?

Why exclude government hospitals if the motive

behind the Act is to ensure minimum standard of


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Worrying state of private health care Tertiary health care is scarce in rural areas Medical health practitioners include those who have

worked has helpers, compounders or assistants ofother doctors

Also includes spouse of doctor, when Sahib is away.Sons and daughters often inherit the practise

Cut practise is well entrenched and institutionalised(Mumbai- cut ratio may be 30- 40% of fee charged,informal associations have standardised ratio of cut)

Deposit

Technical/medical knowledge of doctors isquestionable (Mumbai- 100 doctors prescribed 80different regimen for TB, most of which was expensive

and inappropriate)


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Worrying state of private health care

Administration of unnecessary medicines andinjections is rampant (Jalgaon, M.H.- 72.5%cases recd injection for diarrhoea, 66.7 for coughand cold)

Waiting period to see a Doctor is highly

unreasonable

Patients are hardly informed about side effects ofdrugs prescribed

Fees are exorbitant. Receipt is hardly given. NOstandardization


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Worrying state of private health care

Though there are corporate hospitals, the averagebed capacity of a hospital was found to be 10

62.5 % hospitals in Mumbai located in residential

premises, which means no separate entry/exit andrisk to residents

Private hospitals tend to perform unnecessaryinvestigations, tests, consultations and surgeries (70

per cent of the hospitals where caesareans wereroutine were privately owned Kannan etal, 1991).

In the bigger hospitals there is pressure on thedoctors to ensure that all the beds are occupied at all

times and equipment available in the hospital are


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Study by Sunil N- out of 22 hospitals and nursing homessupposed to have an operation theater (OT), only 15 hadOT, in 7 of them the labour room was combined with theOT. The average area of the OT was less than 100 sq.ft.

It was generally observed that some of the OTs andlabour rooms were in the kitchen. Leakages were to befound in the OT and labour room with paint from theceiling and walls peeling off. As for emergency there

were no supportive services like ambulance services,blood, oxygen cylinders, generators etc. Many of thehospitals and nursing homes were ill equipped,especially those providing maternal health services, forinstance many of them did not have resuscitation sets inthe labour room for new born babies. They do not havedoctors round the clock. Majority of them employunqualified staff. More than 60 percent of the institutionsdid not have a minimum of 50 sq.ft space for each bed.

Lighting facilities were found to be inadequate in 10 of


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Why regulate? Real question is Why not?

Committee Reports, International Obligations(MDG), National Health Policy

India has the biggest health sector in the world A substantial burden on households is to meet

health care needs

Rot in private health care

But public healthcare systems arent a happystory either


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Justification Constitutional obligation- DPSP

Articles 38,42,43 and 47 of the Constitution castsobligation upon the government to make provisionsfor improvement in public health

Thankfully, DPSP cannot be enforced. Otherwise,Public Healthcare Institutions would also be neededto be brought under the KPME Act.

Right to health?


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Arguments against

Official views of Mr. S H Pingle (Secy, IMA- MH)

There should be a range of minimum areas (size) of clinicalestablishments in different settings, as premises in cities are

very costly. Second, there is a severe shortage of qualified personnel as

required by the bill; the shortage of nurses estimated to be 9lakh.

Third, looking at the diversity of conditions in our country, a

common central law may not be practical Onus of responsibility will be on practitioners of modern

medicine and others will be spared.

Public Sector is largely unregulated (yes, but the private sectorhas become the face of healthcare in India and so is justified

to be regulated)


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Regulations relating to MedicalProfession

The Indian Medical Council Act, 1956

The Indian Nursing Council Act, 1947

The Indian Medicine Central Council Act, 1970;

The Homeopathy Central Council Act, 1973; The Pharmacy Act, 1948.


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Regulations pertaining to ClinicalEstablishments Bombay Nursing Homes Registration Act, 1949 The AP Private Medical Care Establishments Act

Delhi Nursing Homes Registration Act, 1953

Madhya Pradesh Nursing Homes Registration Act. 1954

Orissa Clinical Establishment (Control and Regulation) Act, 1991

Punjab State Nursing Home Registration Act, 1991

Manipur Nursing Home and Clinics Registration Act, 1992

Sikkim Clinical Establishments, Act 1995

Nagaland Health Care Establishments Act, 1997

Karnataka Private Medical Establishments Act 2007

The Uttar Pradesh Private Clinical Establishments (Registration and

Regulation) Act, 2009 The West Bengal Clinical Establishments (Registration And Regulation)

Act, 2010.

The Clinical Establishments (Registration and Regulation) Act, 2010[Central Act, applicable to Arunachal Pradesh, Himachal Pradesh,Mizoram, Sikkim and Union Territories]


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What has been regulated?

KPME Act 2007 Duty to attend to Medical Emergency

Implementation of National and State healthprogrammes or any other statutory duty

Maintenance of Clinical records Delivery of Gist of medical procedure and findings

Restriction on furnishing information

Government doctors who serve in PME

Power of entry and inspection

Registration and incidental powers of registeringauthority


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What has been regulated?

KPME Rules, 2009 Locality

Lighting and ventilation

Toilets

Medical Records Bio medical waste

Access to attendingdoctor

Continuing medical

education Qualification of staff

Staff requirement

Discharge summary

Bill of Charges

To put on display- RegCert of State Med council,License of KPME Board,system of medicine,working hours, charges,

name and qualification ofdoctors and consultants

First aid and medico legalservices

Standard of Accomodation

Standard of Equipment Standard of facilities

Compliance withgovernment directives


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What is left out? Body to set standards and for periodical revision

of these standards?

Maintenance of Register of Private MedicalEstablishments?

Price regulation?


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Methodology of regulation Accreditation

Registration

Penalty for non- registration


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Alternatives Self regulation?

Systemic change?


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Shortcomings of the Act

1. Ambiguous1. Consulatation centers must have a whole set of testing

and diagnostic tools pertaining to speciality

2. OT should be 150- 200 sq. feet in area and must have a

scrub area, autoclave room etc?3. Clinical records will be maintained in the prescribed

manner?

4. Trained receptionist?

2. Impractical

1. In hospitals with 51- 100 beds, floor area of 100 sq. feetfor each bed, attached bath and attendant amenities?

2. Dental X ray unit in Dental Clinics?

3. 150 sq. ft of floor area for a single chair in dental clinics?

3.Shoddy implementation


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Shortcomings contd. Immediate attention to be paid to

Uninterrupted power supply?

Display of total cost for carrying out a type oftreatment instead of break up ex. Angioplasty

What about hospitals with more than 500 beds?

Duration of medical records?

Accountability? (Maintenance of register ofregistered hospitals, publication of information)


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Where the Act impresses First step into a hitherto unregulated area

Obligations on Hospitals, and rights to patients

Approach is right- Classification according tonature of service provided and specific rules

Quality assurance- ex. Dentures and otherprosthetics are to be obtained from a qualifieddental mechanic from a certified laboratory


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Field Work Experience of DH&FW office Rural and Urban

Interview of Mr. Arvind Gubbi, Secretary, PrivateHospitals and Nursing Home Association,Bangalore


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Recommendations Constitution of a standard setting body on the

lines of Central Act with members from DirectorGeneral of Health Services, Medical Councils,BIS, Paramedical systems, Consumer groups,

Quality Council of India More man power to Dept. of H&FW

Recognise owners of hospitals as stake holders(need not necessarily be medical professionals)

Greater NGO participation

Classify hospitals and regulate fees and/orprovide health insurance to all


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Conclusion Act- Requires more teeth Implementation- administrative will to implement

the Act is lacking

Moot idea: Can the private healthcareestablishments be forced to open healthcareestablishments in rural areas?

Central Act has brought public healthcare

institutions under its purview. Karnataka tofollow?

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Regulation of Private Health Care Institutions

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