Using Law to Ensure Reproductive and Sexual
Health Rights
Regulations , Standards & Codes
“CLINICAL ESTABLISHMENT ACT”
I.P.H.S and UCPMP
Dr. Mira Shiva MDInitiative for Health & Equity in Society
Consumer Representative in National Council for CEA
Organised byHuman Rights Law Network (HRLN)
AtJaipur
5-6th Dec 2015
Address: Initiative for Health & Equity in Society A-60 Hauz Khas, New Delhi 110016
E-mail: [email protected] 919810582028,01126512385
Regulations , Standards Guidelines and Codes
Acts
Clinical Establishment Act . Mental Health Act . Medical Council of India Act Consumer Protection Act Maternity Benefits Act PCPNDT Act MTP Act
Standards
Only for Public SectorIndian Public Health Standards forSub centre Primary Health Centre (PHC)Community Health Centre (CHC)Sub District hospital District Hospital
National Guidelines
National Guidelines for Biomedical Research in Human Subjects National Guidelines for Stem Cell research & Therapy(DBT,ICMR) 2006National Guideline for Biomedical Research (DBT,ICMR 20140
Codes
Baby Food Code Infant Milk Substitutes Regulation of Marketing Act 1995, amended 2003.
Uniform Code for Pharmaceutical Marketing Practices 2015
Exploitatation & Profit Making
Mega Imaging Path Lab Centre Yusuf Saraifunctioning for several years .Lab reports signed by Dr Anu Kundra MD Pathologist.She had left centre 3 years earlier.Lab reports being given when equipment for the tests did not exist .Medical Treatment given on the basis of lab reports
Clinical Establishments (Registration & Regulation)Act 2010“The Supervision and Regulation of the Quality of services provided by the health care delivery system to the people by both public & private sectors has remained a contentious and unresolved issue .”
“The Private sector health care delivery system in India has remained largely unregulated & uncontrolled . Problems range from inadequate and uncontrolled treatment , excessive use of higher technologies , and wasting of scarce resources to serious problems of medical Malractice and Negligence .”
CEA Rules 2012 Section 9(ii)
“The Clinical Establishments Act shall charge the rates for each type of procedures and services within the range of rates determined & issued by the central Government from time to time , in consultation with the State govts .”
Exploitatation & Profit MakingMega Imaging Path Lab Centre Yusuf Sarai functioning for several years .Lab reports signed by Dr Anu Kundra MD Pathologist.She had left centre 3 years earlier.Lab reports being given when equipment for the tests did not exist .Medical Treatment given on the basis of lab reports
Clinical Establishment Act
Present Health Context- Health Budget 1.2%- 80% Out of Pocket Expenditure Out Patient, 60% in patient- Increasing privatization, commercialization, corporatization of Medical Care- According to NSSO Medical Care 2nd commonest cause of rural indebtedness- Erosion of concept of Comprehensive Health Care
- Alma Ata Charter- Importance of Determinants of Health- Social Sector Budget cuts
- Focus on Currative Care rather than preventive
promotive
- Shift from Universal Health – Universal Health Care -
Terteriary Care
•Increasing costs of medical care, Diagnostics,
Medicines, Medical Devices
•Exploitation in the name of medicine by overcharging,
substandard care, exploitative care, increasing
Caesarian, increasing Hysterectomy
• Not following standard treatment Guidelines (STG)
•Result emergence of antibiotic resistance, Adverse
reaction, Complications, Hospital Infections
• Sterilization deaths, Bilaspur
• Maternal deaths in Umed Hospital, Jodhpur
Corruption
-demand for bribes, oiling of palms for hospital admission- Death certificate for release of Body-Increasing Medical Touts for Kidney Transplants-Payment of Commission to doctors-For prescribing lab test from specific Diagnostic labsSpecific costly brand-Drugs of specific Pharma company for specific ChemistFor referral to specialists-Medical Care – commodifications, growth of medical marketIncreasing Capital investment in medical care market for profits
- Hospital chains- Pharmacy chains- Diagnostic Labs
- Speculation, Growth in capital
intensive Medical Care Model
- Increasing Medical Tourism –
Heart surgery, Hip replacement
- Reproductive Tourism, Surrogacy
Cosmetic Surgery
Growth of medical industrial complex
- Clinical Trials – Pharma sponsors
- Private Medical Insurance
- Medical Device Industries
- Pharmaceutical industry
- Diagnostic
-Medical Device Industry
Public Private PartnershipPublic payment / liability
Private profits
Public state support of private insurance
Dismantling of Institutions
NNMB – National Nutrition Medical Bureau
Unresolved Issues
•Shortages of qualified trained doctors, Nurses, specialists –
concerns about meeting
•Inadequate Health budget for medical equipment, medicines,
incubators, ventilators, Beds
•Role of Para medicals
•Physiotherapists
•Chemists prescribing medicines in absence of prescribing
doctors
•High costs of medical consultation
•Medicines given influenced by Commission offered by Pharma
companies
•Status of unqualified inadequately trained practioners, in absence
of health care facilities and personnel close down? Punish?
Concerns
•In absence of adequate Health Budget Government health institutions being
unable to meet standard
•Smaller private institution being unable to meet standards, including mission
hospitals
•Continued exploitation of patients by certain commercial corporate private
medical institution
•Wiping out of smaller institutions as corporate hospitals chains and speculation
in medical care investment seen as business opportunity
•Increase in costly high tech capital intensive medical care in the name of high
standards
•Implementation and monitoring of CEA requires adequate budget personnel
Medical Council of India Act } have failed to protect and give justice to
Consumer Protection Act } aggrieved patients
Failure of Medical Council of India and Consumer Protection Act to protect
patients and their rights
•Increasing commercialization privatization of medical
education
•Pharmacy, Dental, Nursing education
•Sales of medical admission seats eg. Vyapam scam
•Misuse of Mental Health Act – false certificates to
incarcerate sane women, elderly parents in Mental
Asylum
•National Guideline for Stem Cell research (Therapy
deleted)
•ICMR DBT (earlier National Guideline for Stem Cell
included Research & Therapy)
•In CEA Patients Rights not included
•No provision of Grievance Redressal System
Clinical Establishments Act, 2010
• For Registration and Regulation of the clinical establishments (except thoseof Armed Forces) with a view to prescribe minimum standards of facilitiesand services so that mandate of article 47 can be fulfilled
• The Parliament legislated the Clinical Establishment Act (Registration &Regulation) in pursuance of the resolutions passed by the legislatues ofthe states of Arunachal Pradesh, Himachal Pradesh, Sikkim and Mizoramunder clause (1) article of 252 of the constitution.
• Act passed by Parliament : 17th August 2010
• Act Notified on 1st March, 2012.
• National Council notified: 19th March, 2012
• Central Rules notified : 23rd May, 2012
Applicability
• States - Arunachal Pradesh, Himachal
Pradesh, Mizoram and Sikkim and 6 Union
Territories
• States who have adopted the Act - Uttar
Pradesh, Uttarakhand Rajasthan, Bihar and
Jharkhand
• Such other States who may adopt this Act under
clause (1) of article 252 of the Constitution.
Definition: Clinical Establishment
(i) a hospital, maternity home, nursing home, dispensary, clinic,sanatorium or an institution by whatever name called that offersservices, facilities requiring diagnosis, treatment or care forillness, injury, deformity, abnormality or pregnancy in anyrecognized system of medicine established and administeredor maintained by any person or body of persons, whetherincorporated or not; or
(ii) a place established as an independent entity or part of anestablishment referred to in sub-clause (i), in connection withthe diagnosis or treatment of diseases where pathological,bacteriological, genetic, radiological, chemical, biologicalinvestigations or other diagnostic or investigative services withthe aid of laboratory or other medical equipment, are usuallycarried on, established and administered or maintained by anyperson or body of persons, whether incorporated or not,
Cont.…and shall include a clinical establishment owned,
controlled or managed by
(a)Government or a department of the Government;
(b) a trust, whether public or private;
(c)a corporation (including a society) registered undera Central, Provincial or State Act, whether or notowned by the Government;
(d) a local authority; and
(e) a single doctor
Salient Features & Benefits
• Coverage - All clinical establishments - including diagnosticcentres and single doctor clinics, across all recognized systemsof medicine in both public and private sector.
(exception: establishments of the Armed Forces)
• Registry: Digital registry at National, State & District level toaid in policy formulation and resource allocation
Standard Application FormApplication for registration by post, in person or online
Website www.clinicalestablishments.nic.in functional Implementation by District Registering Authority under
Chairpersonship of District collector. The authority has powerto inspect, grant, suspend and cancel registration
Appeal goes to the State Council
Cont’d Provisional and Permanent registration
Every clinical establishment has to be registered. Normsrequired to be met prior to registration include(a) minimum standards of facilities and services; and (b) minimum qualifications for the personnel. (c) Provision and maintenance of records and reports(d) Any other condition that may be prescribed
National Council for clinical establishments through multistakeholder participation and consultative process wouldclassify clinical establishments into different categories anddetermine minimum standards and their periodic review,determine the statistics to be collected and compile andpublish national register
Cont’d Mandatory for every clinical establishment to provide treatment
“with in the staff and facilities available” to stabilize the emergencymedical condition.
Details of charges, facilities available would be prominentlydisplayed by each establishment at a conspicuous place at eachestablishment
Electronic medical records and EHR
• Clinical Establishments shall charge the rates for procedures andservices with in the range of rates determined by the CentralGovernment from time to time in consultation with the StateGovernments.
• Compliance to Standard Treatment guidelines as may be issued byCentral/State Govt. to be ensured by CEs.
• Penalties: Monetary/ suspension or cancel of registration
Benefits• Comprehensive Digital Registry of clinical establishments
– Policy formulation– Better surveillance, response and management of outbreak & public health emergencies– Engagement with private providers
Uniform standards for a category
Transparency: process of registration & data in public domain.
Multi stakeholder participation in institutional mechanisms (National & State Councils, District Registration Authority)
Effective Regulation of providers.
Improved quality of health care and patient safety
Deterrent against quackery
Better management of Emergency medical conditions
Details of charges, facilities available would be prominently displayed at a conspicuous place at each establishment
Steps taken for implementation of the Clinical Establishment Act 2010
Dedicated website (www.clinicalestablishments.nic.in)
Online registration functional in the States of Jharkhand, Himachal Pradesh and UT of Daman and Diu and Chandigarh.
Nodal Officers in the states
Draft State Rules were circulated for guidance
Secretariat for National Council set up
Budget for implementation through NRHM
Work initiated for standards of EMR and HER
WebsiteEnsure transparency through online system of registration and
information in the public domain
Nat. Council for Clinical Establishments
Preparatory work
Existing standards reviewed to identify the gaps.
Indian Public Health Standards (IPHS) revised
Revised two Bureau of Indian Standards (BIS) documents for upto 30 bedded Hospitals and upto 100 bedded Hospitals.
Developed Guidelines on Daycare Centers and Wellness Centers
Developed and finalized
Application form for provisional registration,
Certificate of Provisional Registration,
information to be displayed by the Clinical establishments
Cont.d
A survey of clinical establishments in 61 districts in the implementing states
Subcommittees of National Council
Categorization and Classification of Clinical Establishments
Development of Standard Template of Minimum Standards
Developing Minimum Standards
Information and Statistics to be collected from Clinical establishments
Defining the range of rates of procedures and services
ProgressMandate Status
States repealing existing
legislations and enacting own acts
on lines of CEA, 2010
Maharashtra, & Goa are in the
process of repealing existing
legislation & enacting one on the
lines of CEA with modifications.
States enacting legislations where
there was no legislations
Kerala, Gujarat, Punjab, Haryana &
Meghalaya are in the process of
enacting legislation on the lines of
central act with modifications
Notification of State rules Notified by – Arunachal Pradesh,
Himachal Pradesh, Bihar,
Jharkhand, Sikkim, Andaman &
Nicobar Islands, Daman, Diu,
Dadar Nagar Haveli, Puducherry,
Uttarakhand
Cont…Mandate Status
Notification of State / UT
council
Notified by – Arunachal Pradesh, Himachal
Pradesh, Bihar, Jharkhand, Rajasthan, Sikkim,
Andaman & Nicobar Islands, Lakshwadeep,
Daman, Diu, Dadar Nagar Haveli, Puducherry,
Uttarakhand
Notification of District
Registration Authorities
Notified by - Arunachal Pradesh, Himachal
Pradesh, Bihar, Jharkhand, Sikkim, Andaman
& Nicobar Islands, Daman, Diu, Dadar Nagar
Haveli, Puducherry. Rajasthan, Uttarakhand
Provisional Registration Online registration in Himachal Pradesh,
Jharkhand and UT of Andaman & Nicobar
Islands, Daman & Diu.
Offline registration in Sikkim Arunachal
Pradesh & Lakshadweep.
Cont…Mandate Status
Categorization & Classification of
Clinical Establishments
Completed and approved by
National Council
Standard Format for Minimum
standard
Completed and approved by
National Council
Development of Minimum
Standards for Clinical
Establishments
Developed draft for 34 specialties/
super-specialties and major
categories of allopathic CE and 7
categories of AYUSH uploaded on
website for
comments/suggestions.
Information & Statistics to be
provided by Clinical
Establishments
Formats Drafted
1. OPD Form
2. IPD Form
3. Lab and Imaging
Fixing of rates & charges Separate sub – committee
engaged in process
Cont…
Mandate Status
Standard Treatment Guidelines
(STG’s)
STG’s for 20 medical domains
developed and AYURVEDA
uploaded on the website
Providing technical assistance and
financial resources
MOHFW, GOI providing technical
assistance to the States for the
implementation through continuous
communication, meetings and visits
to the States and UT’s
Provision of budget for
implementation of the Act & Rules
by the States/UT has been made
through State PIPs from NRHM.
Sensitization & Advocacy and
Training workshops
Stakeholders consultation and
awareness meetings held at
various levels. Recently at
Jharkhand
Standard Treatment Guidelines
1. Cardiovascular Diseases Part - 12. Critical Care3. Gastroenterological Diseases4. Obstetrics and Gynaecology5. Haemodialysis6. Ophthalmology7. ENT8. Orthopaedics9. Medicine (Respiratory)10. Medicine (Non Respiratory Medical Conditions)
11. Paediatrics & Paediatrics Surgery12. General Surgery13. Interventional Radiology14. Oncology15. Organ Transplant - Liver16. Urology17. Laboratory Medicine18. G. I. Surgery19. Neurology20 Endocrinology
Cont…Mandate Status
Comments invited on Draft Documents
(in pipeline)i) . Minimum Standards ii). Application format Permanent Registration iii). Information & Statistics to be collected from Clinical Establishmentsiv).Template of Display of Ratev). Standard Treatment Guidelines of Ayurveda
Comments invited from1. Members of public through
websites for 1 month and 7 days
2. State Governments3. National Council and
respective Subcommittees Comments compiled and discussed with respectivespecialities / superspecialities ---Drafts being finalized for approval
Attempts by allied health personnels like medical technologists, medical microbiology, medical biochemistry to work as independent practitioners
not agreed
States implementing the Act
Arunachal Pradesh
Himachal Pradesh
Mizoram
Sikkim
Uttar Pradesh
Rajasthan
Jharkhand
Chhattisgarh (State Act)
CEA Covers
Recognized system of medicine : Allopathy Homoeopathy Ayurveda, Siddha and Unani Naturopathy Yoga Any other system of medicine recognized by GOI
Definition of a clinical establishment –hospital, maternity home, nursing home, dispensary, clinic, sanatorium, laboratories, radio-imaging centres
CEA Covers
Owned, controlled or managed by:
1. The Government or a department of the Government
2. A trust, whether public or private3. A corporation (including a society) registered
under a Central, Provincial or State Act, whether or not owned by the Government or local authority
4. A single doctor
Only exception - establishments run by the Armed forces.
Some positive features Standard Treatment Guidelines
Charges by hospitals will have to be within the range decided by the government, after following consultative process with stakeholders including representatives from doctors.
Clinical establishments will have to display charges for some of the typical main items like consulting charges, room charges etc.
Electronic record maintenance
Minimum standards for Clinical Establishments
Clause 12- Condition for registration
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.