Laws and Regulations governing Private Health Care Establishment in Karnataka, with special focus on Karnataka Private Medical Establishment Act, 2007 and Rules, 2009.
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
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
sponsored by
State/Central govt PSU Co- operative societies owned or controlled by
establishments? Why exclude government hospitals if the motive behind the Act is to ensure minimum standard of
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)
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
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
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?
(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)
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]
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
Methodology of regulation
Accreditation
Registration
Penalty for non- registration
Alternatives
Self regulation?
Systemic change?
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)
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
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
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?