K.P.M.E. Act and Rules Dr Raghunanan MD (Gen.Med) Joint Director (Medical) Health and Family Welfare Department KARNATAKA ACT NO.21 OF 2007 (First Published in the Karnataka Gazette Extra-ordinary on the sixteenth day of August, 2007) THE KARNATAKA PRIVATE MEDICAL ESTABLISHMENTS ACT, 2007 (Received the assent of the Governor on the thirteenth
day of August, 2007) KPME Rules were under subsection 1 of sec 26 of KPME Act Notification No HFW 94 CGE2008 Bangalore dated 15th sept 2009 preamble The law was enacted in public interest to Promote Quality health care by stipulating Minimum standards keeping with the principles of medical ethics. Monotoring by law Running of Private Medical Establishments. Aim and Objective Objectives of the KPME Act
The specific objectives are i) To establish digital registry of Private Medical Establishments in the state of Karnataka. ii) To prevent quackery by unqualified practitioners by introducing registration system, which is mandatory. iii) To prescribe minimum standards of facilities and services for all categories of health care establishments and ensure compliance of other conditions for registration like standards treatment protocols, display of range of rates to be charged, maintenance of records etc Existing Provisions in Section 6-Prerequisites
Important aspects of Prerequisites during registrations. Staffing of qualified Doctors and Paramedical Personnel as per the standards in Sections 9 and Requirement as per schedule E in the rules. Adequate place and building to house equipments and other infrastructural facilities and as per section Schedulen 8 and Prescribed standards in Schedules A,B,C,D&E. Maintainance of Clinical Records as per section 12and maintain records in respect of each patient. Section 11 Obligations of Private Medical
Establishments, 1) All Doctor in Private Medical Establishments, should administer necessary first aid and life saving emergency measures in all MLC causes and victims of road accidents, burns, poisoning or assaults. 2) Actively participate in the implementation of all national and State health programmers and furnish reports to public health authority. 3) All non Communicable diseases notified by the state government should be reported to district health authority.
Section-10 Notification of Schedule of Charges E Every Private Medical Establishment shall display schedule of charges for different medicals Treatment and other Services in a prominent location in side the establishment. Display board compulsory and mandatory. Establishment is also required to print brochures or booklets contain charges and give it the patient for information. Non Compliance with regard to the above is considered as violation of section-10 and Action will be taken as per the KPME Act. Section 19 and 20 deals with penalties and offences by the company
Penalties are for nonregistration Contravention of provisions of section 12 and 13 Which deals with maintainance of clinical records and providing discharge details of the patient. Section 21 Power of entry inspection etc. Every Clinical records shall be open to inspection, , in due discharge of his duties, by DHO or any other officer specifically empowered in this behalf by the Government. Under Act-21, State Government may authorize any officer of the government & empower him as authorized officer who can enter, at all
reasonable times, and with such assistants if any, to inspect private medical establishment. He Can make such examination of the premises, & examine any registrar, record, equipment article for analysis and Investigation. The authorized office after seizing documents and records shall intimate the reason tor such seizure to the Manager of the PME. Provisions for bringining Amendments Under section 26 of the act Government can make rules for carrying out purposes of the act 26 (b) Such other factors for registration under section 6
Section 6 deals with prerequisites and about I to v prerequisites are mentioned In the 5th prerequisite it is mentioned Such other factors as may be prescribed. There are matters which are expressively required to be prescribed which the act has not made provision in its mother act (original or principal act). Need for legislation urgent need to introduce amendments in KPMEA Article 47 (Constitution) mandates improvement in public health. As per NSSO data of 60th round, the private sector today provides
nearly 80% of outpatient care and about 60% of inpatient care. By NSSO estimates as much as 40% of the private care is likely to be by informal unqualified providers out-of-pocket payments still account for a very large share, 5971% of total health spending. Most such payments are made to private providers. unprecedented growth of Private sector but it largely remains unregulated. Thus health regulation continues to be unresolved.. Continued Thus there is a general perception that current regulatory processes are inadequate or do not ensure health care services of acceptable
quality and that which prevent negligence lack of complete information with the policy makers regarding available private health care resources in different parts of the karnataka which is required for appropriate policy formulation. Need of the hour is systematic collection of information from private health establishments. An important consideration is "High cost of Healthcare in private sector which raises the issue of affordability and also equity". Present State of regulation of healthcare infrastructure and sevices.
Healthcare in India suffers from underregulation subjecting the population to poor quality of treatment,quackery menace and high costs.This makes imperative to enforce minimum standards on private medical establishments. At times Patient safety is compromised Financing and service delivery are not transparent and accountable making delivery of healthcare prejudiced against the poor High cost of healthcare in private sector raises the issue of affordability and equity. Technical quality of healthcare depends on depends on competence of the health personnel,facility and infrastructure which can be ensured in accredited hospitals
Rule Under Rule 26 Government can make rules by notification or after previous publication The following list of prerequisites are expressively required by the government and the act has not made any provision. 1.Formation of State Monitoring Cell which functions in the directorate under administrative control of commissioner of health and family welfare (Functioning of state monitoring cell is on the similar lines of state council for Clinical establishment act of central government)
Continued Comprehensive and appropriate Policy formation which can be done from time to time as there is availability of systemic data collected and centralized at state Monitoring cell Comprehensive Digital Registry of Private Medical Establishments and systematic collection of data will help in Better Policy formulation Better surveillance, response and management of outbreak & public health emergencies Better Engagement with private health care providers Continued.
Clinical Establishments categorized into categories which makes it feasible to prescribe uniform standards for a category achieving Transparency in the Process of registration, and publishing the data in public domain. Details of charges, facilities available would be prominently displayed at a conspicuous place at each establishment Prescription of standard treatment protocols and minimum standards from time to time will improve the quality of health care as care is based on standard treatment protocols and minimum standards Emergency Trauma services
As a mandatory requirement for Registration the private medical establishment has to give an Undertaking to provide within the staff and facilities available such medical examination and treatment as may be required to stabilize the emergency medical condition of any individual brought to any such establishment---under sec 11 of the act In view of good Samaritan bill and the proposed act it is mandatory for every doctor to attend the Road traffic accident case or any emergency case. Penalty clause to be included in the rules hefty monetary fine to be imposed Rule amendment is a must Grievance Redressal Mechanism
There is a growing demand for a grievance redressal mechanism for patients in case of violation of the standards and punishment for avoidable lapses there needs to be a redressal policy drafted by the hospital authorities. Act has not made any provision for Grievance redressal policy. Most of the hospitals do not have grievance redressal policy Mandatory Prerequisite for registration Redressal policy as per NABH guidelines Citizens Charter A very important Prerequisite without which hospitals should never be registered
Citizens Charter explaining the patients rights and responsibilities and the doctors responsibilities should be exhibited in the lobby or in a prominent place in the hospital It shall be in English, kannada & national language Act has not made any provision for citizens Charter Inclusion in the rule amendment mandatory Standard treatment Guidelines The standard treatment protocols, in principle, are a good idea as it helps ensure certain basic standards of treatment. Act has not made suffient provision. Policy document containing sops shall be Required as a essential
prerequisite for registration Physicians should have adequate freedom to decide as per their learning and experience, which modality of treatment to use in which situation in broad compliance with the protocols practiced by the professional community nationally and internationally. Training, IEC and enforcement activities. There is need for training/orientation for district administrators in general and for district registration committee members in particular. There is need for awareness drives for public to know about such regulation and specifically targetted to private providers
Act has not made provision for these activities. Structured and focused IEC activities should be included in the KPME rules Administrators District Registration authority and other officials of local inspection committee should undergo training in the implementation, and effective monitoring. Offences and Penalty Clauses Both Imprisonment and Monetary values of Penalties for offences committed by private Medical establishments need to be increased especially when they do acts in contravention of conditions of registration under section 6 or contravenes the provisions of section 12 and 13
The quantum of monetary penalties to be decided and recommended by the expert committee. Accountability and responsibility of the hospital will increase Effective Regulation of health care providers would occur from the centralised cell from directorate after required amendments of the KPME Act and rules Grivance Redressal Mechanism of KPME Need to create simple mechanism for patients to complain Eg phone line, E-Mail, whatsup etc.. This system enables aggrieved patients to make complaints to AA
Develop Clarity on penalty structure/amount and enable local inspection committee and DRA to levy Penalty. It is an excellent mechanism where in more and more cases of negligence and malpractice are brought to light so that preventive and corrective action can be taken. KPME has not made provision.Rules to be mandatorily framed and a stable Policy to be in Place. Data Sharing In the obligations of Private medical establishments very important rule to be brought about is data collection, compilation and sharing of all the data onNational Programmes especially RCH Programmes
Communicable and Noncommunicable diseases etc.. Although there are provisions in the act and rules for reporting of essential data Reporting Needs software and interfaces for data sharing which can be developed ny NIC. Any violations should be dealt with hefty fines. Provision for penal clauses to be included in the rules. Web-portal registration Optimization from time to time after bringing amendments Gray areas clarifying ownership how healthcare establishments under
different types of Public-Private Partnerships would be treated; ensuring pricing options are automatically selected based on category of establishments opted based on set criteria. allow preparation of digital reports based on selections. allow re-submission for correction of minor errors, such as spelling mistakes. Summary The need and urgency to create monitoring cell at the state level to address the gaps in enforcement and effective implementation of the act has been well emphasized Regulation and enforcement of rules for data transparency and sharing of data by Private establishments with the government.
Costing to arrive price range for medical procedures and cost range for other fees such as fees for registration with the hospital, fees for medical records etc. Standard guidelines applicable for each type of medical Practice governed by the act. Grievance redressal for patients Maintenance of State wide electronic records of district wise Registration status. Manage money collected from registration fees ,fine and other levys received as penalties from violations of the act in a judicious manner Aid and Assist the appellate Authority in all day to day issues . Final Conclusion and Summary In order to accomplish the objectives and goals of the act and reap the benefits of the act with regard to promotion and monitoring of quality
healthcare Government needs to constitute and appoint expert committee and subcommittees 1.To suggest the standards for different class or classes of Private medical establishments for different areas from time to time. 2.The composition, powers and responsibilities, of the Expert Committees and the terms and conditions of service of members of the Expert Committee shall be prescribed. Thank You one and all for patient hearing
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