The clinical establishments (registration and regulation) act 2010 and rules 2012


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The clinical establishments (registration and regulation) act 2010 and rules 2012

  1. 1. ByDr.Priyanka srivastava Department of Hospital Administration SGPGIMS, Lucknow
  2. 2. Regulation of quality of services provided by healthcare delivery system to the people by both public and private sectors has largely remained a contentious and therefore, unresolved issue. Private sector healthcare delivery system in India has remained largely unregulated and uncontrolled.
  3. 3.  Concerns about how to improve healthcare quality continue to be frequently raised by the general public and a wide variety of stakeholders, including Government, professional associations, private providers, agencies financing healthcare, Human Rights Commission and judiciary among others.
  4. 4.  Despite many state legislatures having enacted laws for regulating healthcare providers, the general perception is that current regulatory process for healthcare providers in India is inadequate or not responsive to ensure healthcare services of acceptable quality and prevent negligence  A need has been felt for a central legislation for ensuring uniform standards of facilities and services by the clinical establishments throughout the country
  5. 5. This Act is for the Registration and Regulation of the clinical establishments in the country and for matters connected therewith.  Act passed by Parliament in Aug 2010 and notified on 1st march,2012. National Council under the Act notified on 19th march 2012 and Central Rules notified on 23rd may 2012.
  6. 6.  Model State Rules have been circulated to the State/UT’s . Ministry has requested the chief ministers to adopt and implement the act  Highest priority of gov for implementation and monitored by the PMO
  7. 7.  States – Arunachal Pradesh, Himachal Pradesh, Mizoram and Sikkim.  Union Territories – Andaman and Nicobar Islands, Chandigarh, NCT of Delhi, Dadra and Nagar Haveli, daman and Diu, Lakshadweep, Pondicherry.  States who have adopted the act – Uttar Pradesh , Rajasthan and Jharkhand.  Such other states which adopt this act under clause (1) of article 252 of the constitution
  8. 8.  Does not include the clinical establishments owned, controlled or managed by the Armed Forces.
  9. 9.  An act to provide for the registration and regulation of clinical establishments in the country.  To prescribe minimum standards of facilities and services which may be provided by them.  Desired impact : improvement in public health.
  10. 10. Parliament has no power to make laws for the states with respect to any of the matters aforesaid articles 249 and 250 of the constitution.
  11. 11.  A hospital, maternity home, nursing home, dispensary, clinic, sanatorium or an institution by whatever name called that offers services, facilities requiring diagnosis, treatment or care for illness, injury, deformity, abnormality or pregnancy in any recognized system of medicine established and administered or maintained by any person or body of persons, whether incorporated or not; or
  12. 12.  a place established as an independent entity or part of an establishment referred to in sub-clause (i), in connection with the diagnosis or treatment of diseases where pathological, bacteriological, genetic, radiological, chemical.  biological investigations or other diagnostic or investigative services with the aid of laboratory or other medical equipment, are usually carried on, established and administered or maintained by any person or body of persons, whether incorporated or not
  13. 13.  COVERAGE – All clinical establishments – including diagnostic centers and single doctors clinics, across all recognized systems of medicine in both public and private sector. (exception establishments of the armed forces ).  REGISTRY – Digital registry of all types of clinical establishments at national state & district level available in public domain .registry would aid in policy formulation and resource allocation.
  14. 14.  STANDARD APPLICATION FORM - For registration of clinical establishments to ensure uniformity of information. Application for registration by post, in person, or online.  TRANSPARENCY – Entire process of registration and data in public domain. data collected to be utilized for public health interventions.  Implementation of the act is with states. District registering authority under chairperson ship of district collector .
  15. 15.  The district health officer / chief medical officer will exercise the power of the district registering authority for provisional registration of clinical establishments .  Since information in public domain , any complaints appropriate action can be taken  The authority shall have power to inspect a registered clinical establishment with prior information.
  16. 16.  Any person aggrieved by an order of the registering authority shall refer an appeal to the state council.  Provisional registration, through a process of self declaration without any inspection .  Permanent registration would be undertaken after categorization and development of minimum standards.
  17. 17.  Every clinical establishment has to be registered – norms required to be met prior to registration include: 1. Minimum standards of facilities and services 2. Minimum qualifications for the personnel 3. Provision and maintenance of records and reports 4. Any other condition that may be prescribed
  18. 18.  National council, through multi stakeholders participation and consultative process would classify clinical establishments into different categories and determine uniform minimum standards and their periodic review.  A survey of existing clinical establishment has been outsourced to QCI –IMA for defining draft minimum standards
  19. 19.  Mandatory for every clinical establishment to provide treatment “ with in the staff and facilities available” to stabilize the emergency medical condition.  Details of charges, facilities available would be prominently displayed by each establishment at a conspicuous place at each establishment.
  20. 20.  Clinical establishments shall charge the rates for procedure and services with in the range of rates determined by the central government from time to time in consultation with the state governments .  Compliance to standard treatment guidelines as may be issued by central /state govt. to be ensured by CEs.
  21. 21.  If any person contravenes any, provisions of the proposed legislation or any rules made thereunder, he shall be punished with fine and wide ranging penalties.  Amounts collected by way of fees, fines, penalties etc. to be utilized for implementation of the act.  Cancelation of the registration would occur at any time, if conditions for registration are not compiled.
  22. 22.  There shall be established for the purposes of this act, a council to be called the National Council for clinical establishments.  Chair Person: Director-General of Health Service, Ministry of Health and Family Welfare  Secretary: Joint Secretary MOH GOI  Compile and publish a National Register of clinical establishments within two years from the date of the commencement of this act; ;
  23. 23.  Classify the clinical establishments into different categories;  Develop the minimum standards and their periodic review Determine within a period of two years from its establishment, the first set of standards for ensuring proper healthcare by the clinical establishments;  Collect the statistics in respect of clinical establishments;  Perform any other function determined by the Central Government from time to time.
  24. 24. Every state government shall constitute a state council for clinical establishments. a. Secretary, Health – ex officio, who shall be the chairman; b. Director of Health Services – ex officio member-secretary
  25. 25. 1. Compiling and updating the State Registers of clinical establishment; 2. Sending monthly returns for updating the National Register; 3. Representing the State in the National Council; 4. Hearing of appeals against the orders of the authority; and 5. Publication on annual basis a report on the state of implementation of standards within their respective states.
  26. 26. The state government shall, set-up district registering authority. a. District Collector - Chairperson b. District Health Officer – Convener c. 3 members 1. From police 2. From NGO 3. From Professional association
  27. 27. The District registering authority shall be responsible for  Grant, renewal, suspension or cancellation of registration  Enforcing compliance  Investigation of complaints  Preparation and submission of report The District Medical Officer shall exercise the powers of the district health authority
  28. 28.  Provisional registration with time limit  Inspection  Permanent registration  Standards for permanent registration  The certificate shall be valid for a period of five years from the date of issue.
  29. 29. For registration and continuation, every clinical establishment shall fulfill the following conditions, namely :I. The minimum standards of facilities and services as may be prescribed; II. The minimum requirement of personnel as may be prescribed; III. Provisions for maintenance of records and reporting as may be prescribed; IV. Such other conditions as may be prescribed.
  30. 30.  The clinical establishment shall undertake 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 who comes or is brought to such clinical establishment.
  31. 31.  Monetary penalty for non-registration  Disobedience of order, obstruction and refusal of information  Every clinical establishment shall, furnish such returns or the statistics and other information in such manner, as may be prescribed  shall maintain medical records of patients treated by it and health information and statistics in respect of national programmers and furnish the same to the district authorities in form of quarterly reports.
  32. 32.  copies of all records and statistics shall be kept with the clinical establishment concerned for at least 3 or 5 years.  shall comply with the Standard Treatment Guidelines and maintain electronic medical records of every patient as may be notified by the Central Government from time to time.  shall charge the rates for each type of procedure and service within the range of rates to be notified by the central government from time to time, for such procedures and services.
  33. 33.  shall display the rates charged for each type of service provided and facilities available, for the benefit of the patients at a prominent place in the local dialect and as well as in English language.  shall establish mechanisms for review and audit for the purpose of provision of rational practice and service.  shall carry out every prescription audits every 3 months.
  34. 34.  Clinical establishment act aims for quality health care for own people  Quality health care has three components  Freedom for errors  Consistent best practices  Great service - A safe system A reliable system A great system
  35. 35. THANK YOU