Regulation of Private Health Care Institutions

Laws and Regulations governing Private Health Care Establishment in Karnataka, with special focus on Karnataka Private Medical Establishment Act, 2007 and Rules, 2009.

Medical/ Health Care Establishments?

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

Laboratory, Diagnostic Centre, Maternity Home, Blood Bank, Radiological Centre, Scanning Centre, Physiotherapy Centre, Clinic, Polyclinic, Consultation Centre and such other establishments by whatever name called where investigation, diagnosis and preventive or curative or rehabilitative medical 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 of

medicine

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

What is to be understood as private?

Every medical establishment which is not run or

sponsored 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

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 of other 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 is questionable (Mumbai- 100 doctors prescribed 80 different regimen for TB, most of which was expensive and inappropriate)

Worrying state of private health care

Administration of unnecessary medicines and

injections is rampant (Jalgaon, M.H.- 72.5% cases recd injection for diarrhoea, 66.7 for cough and cold) Waiting period to see a Doctor is highly unreasonable Patients are hardly informed about side effects of drugs prescribed Fees are exorbitant. Receipt is hardly given. NO standardization

Worrying state of private health care

Though there are corporate hospitals, the average

bed capacity of a hospital was found to be 10 62.5 % hospitals in Mumbai located in residential premises, which means no separate entry/exit and risk to residents Private hospitals tend to perform unnecessary investigations, tests, consultations and surgeries (70 per cent of the hospitals where caesareans were routine were privately owned Kannan etal, 1991). In the bigger hospitals there is pressure on the doctors to ensure that all the beds are occupied at all times and equipment available in the hospital are

 Study by Sunil N- out of 22 hospitals and nursing homes

supposed to have an operation theater (OT), only 15 had OT, in 7 of them the labour room was combined with the OT. The average area of the OT was less than 100 sq.ft. It was generally observed that some of the OTs and labour rooms were in the kitchen. Leakages were to be found in the OT and labour room with paint from the ceiling and walls peeling off. As for emergency there were no supportive services like ambulance services, blood, oxygen cylinders, generators etc. Many of the hospitals and nursing homes were ill equipped, especially those providing maternal health services, for instance many of them did not have resuscitation sets in the labour room for new born babies. They do not have doctors round the clock. Majority of them employ unqualified staff. More than 60 percent of the institutions did not have a minimum of 50 sq.ft space for each bed. Lighting facilities were found to be inadequate in 10 of

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 happy story either

Justification
Constitutional obligation- DPSP
Articles 38,42,43 and 47 of the Constitution casts

obligation upon the government to make provisions for improvement in public health Thankfully, DPSP cannot be enforced. Otherwise, Public Healthcare Institutions would also be needed to be brought under the KPME Act.
Right to health?

Arguments against
Official views of Mr. S H Pingle (Secy, IMA- MH)
There should be a range of minimum areas (size) of clinical

establishments 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 9 lakh. 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 sector has become the face of healthcare in India and so is justified to be regulated)

Regulations relating to Medical Profession

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.

Regulations pertaining to Clinical Establishments

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]

What has been regulated?

KPME Act 2007 Duty to attend to Medical Emergency Implementation of National and State health programmes 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 registering authority

What has been regulated?

KPME Rules, 2009 Locality Lighting and ventilation Toilets Medical Records Bio medical waste Access to attending doctor Continuing medical education Qualification of staff Staff requirement Discharge summary Bill of Charges
To put on display- Reg

Cert of State Med council, License of KPME Board, system of medicine, working hours, charges, name and qualification of doctors and consultants First aid and medico legal services Standard of Accomodation Standard of Equipment Standard of facilities Compliance with government directives

What is left out?

Body to set standards and for periodical revision

of these standards? Maintenance of Register of Private Medical Establishments? Price regulation?

Methodology of regulation
Accreditation

Registration
Penalty for non- registration

Alternatives
Self regulation?

Systemic change?

Shortcomings of the Act

1.

Ambiguous
1.
2. 3. 4.

Consulatation centers must have a whole set of testing and diagnostic tools pertaining to speciality OT should be 150- 200 sq. feet in area and must have a scrub area, autoclave room etc? Clinical records will be maintained in the prescribed manner? Trained receptionist?
In hospitals with 51- 100 beds, floor area of 100 sq. feet for each bed, attached bath and attendant amenities? Dental X ray unit in Dental Clinics? 150 sq. ft of floor area for a single chair in dental clinics?

2.

Impractical
1. 2. 3.

3.

Shoddy implementation

Shortcomings contd.
Immediate attention to be paid to
Uninterrupted power supply? Display of total cost for carrying out a type of

treatment instead of break up ex. Angioplasty What about hospitals with more than 500 beds? Duration of medical records? Accountability? (Maintenance of register of registered hospitals, publication of information)

Where the Act impresses

First step into a hitherto unregulated area

Obligations on Hospitals, and rights to patients

Approach is right- Classification according to

nature of service provided and specific rules Quality assurance- ex. Dentures and other prosthetics are to be obtained from a qualified dental mechanic from a certified laboratory

Field Work
Experience of DH&FW office Rural and Urban

Interview of Mr. Arvind Gubbi, Secretary, Private

Hospitals and Nursing Home Association, Bangalore

Recommendations
Constitution of a standard setting body on the

lines of Central Act with members from Director General 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/or provide health insurance to all

Conclusion
Act- Requires more teeth

Implementation- administrative will to implement

the Act is lacking Moot idea: Can the private healthcare establishments be forced to open healthcare establishments in rural areas? Central Act has brought public healthcare institutions under its purview. Karnataka to follow?