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: mirashiva@gmail.comPH 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.