CLINICAL ESTABLISHMENT ACT

IDA TAMIL

BY
DR.J.SELVAKUMAR M.D.S
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IInd Vice-PRESIDENT , IDA MADRAS Branch

DISCLAIMER
 The Clinical Establishments
(Registration and Regulation)
Act 2010 and Rules 2012
Act 2010 Rules 2012
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 WHAT IS CLINICAL ESTABLISHMENT ACT?

The Clinical Establishments Act provides for

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registration and regulation of clinical establishments in

the country
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WHO IS INCLUDED?
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 WHO IS EXCLUDED?
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 WHEN WAS THE ACT INTRODUCED
FIRST?

*2007 in Parliament by Shri.Anbumani Ramadoss

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*Referred by Shri.Amov Singji

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 WAS IT ACCEPTED?

No, Parliamentary committee rejected the said Bill

citing some reasons
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 WHEN WAS ACT PASSED IN THE
PARLIAMENT?

*Again introduced in the Parliament by then

Health Minister Hon’ble Shri.Gulam Nabi Azad in
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2010
*National council under the Act notified on 19th
March ,2012 and Central rules notified on 23rd
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May ,2012
 WHAT ARE THE SALIENT FEATURES OF
THE ACT?
ASSISTS IN RELIABLE AND COMPREHENSIVE DATABASE
*

*CATEGORISE THE CLINICAL ESTABLISHMENTS

*DEFINES BASIC MINIMUM STANDARDS

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*ESTABLISHES MULTI-STAKEHOLDER BODIES

*TWO STEP REGISTRATION PROCESS-PROVISIONAL AND PERMANENT
*ENSURES TRANSPARENCY
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*CONTROL QUACKERY
 WHAT ARE THE OBJECTIVES OF THE ACT?
 Improvement in public health quality

 To prescribe basic minimum standards

 Provision of proper healthcare

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 Collect the required statistics

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 WHAT IS THE CURRENT NATIONAL
SCENARIO?
Come into force in the states of Arunachal Pradesh, Sikkim, Mizoram,
Himachal Pradesh and all Union Territories except Delhi from 01 March
2012.
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Uttar Pradesh, Bihar, Rajasthan, Jharkhand and Uttarakhand have adopted

the Act by passing resolution in their respective State assemblies.
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 WHAT ARE THE STATES HAVING THEIR
OWN ACT LISTED IN SCHEDULE TO CEA
AND EXEMPT FROM CE ACT?
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West Bengal,Maharashtra,Andhra
Pradesh,Odisha,Delhi,Manipur,Nagaland,Madhya
Pradesh,Punjab
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 WHAT ARE THE STATES THAT ENACTED
THEIR OWN ACTS?

Jammu and Kashmir,Karnataka,Chhattisgarh,Tamil

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Nadu(not implemented)
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 WHAT IS THE ROLE OF THE CENTRAL
GOVERNMENT IN IMPLEMENTATION OF
THE ACT?
 Notification of the Act
 Notification of the National Council and Rules for the functioning
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 Classification & Categorization of the Clinical Establishments

 Establish Minimum Standards
 Assistance for the drafting of Rules
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 WHAT IS THE ROLE OF THE STATE
GOVERNMENT IN IMPLEMENTATION OF
THE ACT?
Constitute & notify the State / Union Territory /District
Registration Authorities
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Provisional registration
Notification of State Rules
Identification and notification of Registrars of Clinical
Establishment at State Level (Director of Health Services)
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and District level (District Health Officer)

 IS THERE ANY COUNCIL SET UP?

 YES
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 The Union Health Ministry has constituted a National

Council for Clinical Establishments
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 WHO ARE ALL MEMBERS IN THE
NATIONAL COUNCIL FOR CLINICAL
ESTABLISHMENTS?
 Dental, Medical, Nursing and Pharmacy councils
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Three representatives from the Central Council of Indian Medicine

(Ayurveda, Siddha and Unani),

 One member from the Central Council of Homoeopathy

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 One member from the Central Council of the Indian

Medical Association
 Includes a chairperson and a secretary
 The Bureau of Indian Standards will also be members.
 WHAT ARE THE FUNCTIONS OF THE
NATIONAL COUNCIL?
Compile and publish a National Register
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Develop the minimum standards

Classify the clinical establishments
Ensuring proper healthcare by the clinical establishments
Collect the statistics
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 DO WE HAVE A STATE COUNCIL FOR
CLINICAL ESTABLISHMENTS?

Yes,Every State Government shall constitute a

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State Council for Clinical Establishments

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 WHAT IS THE COMPOSITION OF STATE
COUNCIL OF CLINICAL
ESTABLISHMENTS?
Secretary, the Chairman
Director of Health Services
Directors of different streams of Indian Systems of Medicine
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Representations from:
- Dental, Medical, Nursing and Pharmacy councils
- Ayurveda, Siddha and Unani systems of medicines
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- State Council of the Indian Medical Association

- Paramedical systems
- State level consumer groups
 WHAT ARE THE FUNCTIONS OF THE
STATE COUNCIL?
Compiling and updating the State Registers
Representing the State /Union Territory in the National Council
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Hearing of appeals
Publication on annual basis report
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 WHAT IS THE SET UP IN DISTRICT LEVEL?

The state government shall set up the district

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registering authority
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 WHAT IS THE COMPOSITION OF DISTRICT
REGISTERING AUTHORITY?
The Dean of a Government Medical College in the district
The District Siddha Medical Officer
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The Deputy Director of Medical and Rural Health Services- chairperson

Members from:
- Tamil Nadu Medical Council
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- One member nominated by the Indian Medical Association

-Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homeopathy
system of medicine
- Tamil Nadu Nurses and Midwives Council.
 WHAT ARE THE FUNCTIONS OF DISTRICT
REGISTERING AUTHORITY?
Grant, renewal, suspension, cancellation of registration
Investigations
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Enforcing compliance
Preparation and submission of reports
Other duties as may be directed by the competent authority
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 WHAT ARE THE MERITS OF THE ACT?

 Helps in countrywide planning and positioning of physicians and

healthcare establishments
Improve the standards of healthcare establishments
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Uniformity in standards of case across the country

Crackdown on quackery
Categorise the clinical establishments
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Improvement in public health

 WHAT ARE THE DEMERITS OF THE ACT?


Geo-Socio-Economic reasons-Health is a state subject

Increase the establishment cost directly escalating the treatment costs

Affects smaller healthcare units
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
Establishment cost, maintenance cost, salary, equipments

Lack of proficiency in emergency healthcare

Impossible in rural areas

Forcing the caregivers will not benefit the patients
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
Standard tariffs are not feasible

Might create avenues of corruption

Might promote corporate culture

Penalty should be reduced to reasonable charges
 WHAT ARE THE CONDITIONS FOR
REGISTRATION OF A CLINICAL
ESTABLISHMENT UNDER THIS ACT?

The Minimum standards of facilities and services

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The minimum requirements of personnel

Provisions for maintenance of records
The clinical establishment shall undertake to provide within the staff and
facilities available such medical examination and treatment as may be
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required to stabilize the emergency medical condition of any individual who

comes or is brought to such clinical establishment
 ARE THERE ANY OTHER CONDITIONS?
Display the Registration certificate at a prominent place.
Display the rates charged for each type of service provided and facilities
available
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Ensure compliance with Standard Treatment Guidelines

Maintain and provide Electronic Medical/Health Records of every patient
Maintain and provide information and statistics
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INSPECTIONS
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 WHAT IS THE PENALTY?

Penalty for first offence of not following any of the

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provisions is up to Rs.10,000, for second time up to

Rs.50,000, for subsequent offences up to Rs.5 Lakhs.
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 WHAT ARE THE MINIMUM FACILITIES IN
A CLINICAL ESTABLISHMENT STATED IN
TAMIL NADU GOVERNMENT GAZETTE?
Following should be in accordance with the norms and conditions
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specified
The floor space and other facilities,
Minimum number of staff
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Minimum qualification,
Minimum equipment
Different medical services including specialized services
 WHAT IS THE DIFFERENCE BETWEEN A DENTAL CLINIC
AND A DENTAL HOSPITAL STATED IN THE TAMIL NADU
GAZEETE?

“Dental clinic” means a clinic where treatment for dental ailments is

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given
“Dental hospital” means a place where patients are treated as
inpatient and treatment is given for dental ailments
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 WHAT ARE THE NORMS AND CONDITIONS FOR
A DENTAL CLINIC BUILDING?

 The consulting room -not less than 100 square feet.

 Well ventilated and lighting
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 Space for - Sterilizer and Trays

 Space for patient waiting
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 WHAT ARE THE SPECIFICATION FOR STAFFS
IN A DENTAL CLINIC?
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Dental Surgery, Consultation and prescription shall be performed by

a qualified Dental Surgeon only as per the Indian Dentist Act, 1948
Administration of anesthesia - by the dental surgeon himself
 X-Ray –by a Radiographer or the Dentist.
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 WHAT ARE THE BASIC EQUIPMENTS NEEDED
IN A DENTAL CLINIC?
Dental Chair
Provision of water for surgery
Sterilizer
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Bin for sterile cotton gauze etc.,

Trays with instruments
Dental instruments
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X-Ray (desirable)
Disposable (optional) / autoclaved syringes.
 WHAT ARE THE MANDATORY REQUIREMENTS FOR A
STAND ALONE DENTAL SET UP?
Dental Chair cum unit-1
Dental surgeon in charge with qualification and registration-BDS/MDS
Timings and Consultation/Fee structure: To be displayed separately
Space requirement for waiting room, consulting room and treatment room-
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Minimum 100 square feet

Safe drinking water, Furniture & Fixtures , Electrical facilities
Communication system
Qualification of Incharge dental surgeon-BDS/MDS
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1 Assistant/Dental Nurse per Chair

Dental Chair Cum Unit,RVG/Dental X-ray unit
Periodic health check up and vaccination against Hepatitis B for doctor and staff
Sterilization -Autoclave
 MANDATORY REQUIREMENTS CONTINUED…

Consumables and disposables required

-All Restoration Materials, Endodontic material, all material for extraction of mobile and semi
mobile teeth, all material for scaling and polishing fissure, sealant and fluoride
Annual Maintenance protocol for equipment and its record of maintenance
Registration with State pollution control board
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Fire safety certificate

Biomedical Waste management
X-ray with AERB norms
Building stabiity and building approval certificate
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Out and In patient records

Confidentiality of Medical records,
Record keeping of personnel working in dental clinic indicating their details including qualification
and training
Safety considerations, Patient Information and Education
 WHAT ARE THE DESIRABLE REQUIREMENTS FOR A
STAND ALONE DENTAL SET UP?
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Dental X-Ray-RVG-Own/Outsourced
Receptionist
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 WHAT ARE THE RECORDS TO BE MAINTAINED
IN A DENTAL CLINIC?

A record of the patients treated along with name, age, sex, disease
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and treatment given shall be available

A slip shall be given to the patient with all the above particulars.
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 WHAT ARE THE NORMS AND CONDITIONS FOR
A DENTAL HOSPITAL?

The outpatient department of a dental hospital shall confirm to the

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norms prescribed to a Dental Clinic.

Sufficient waiting room
Wards, Operation Theatre and other aspects shall be as per the
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norms prescribed to the nursing homes and hospitals.

 WHAT ARE THE GENERAL CONDITIONS TO BE
FULFILLED BY THE HOSPITAL?
Communication
Security
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Fire fighting
Clean clothing and linens changed daily
Water Supply
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Waste Disposal
Record maintenance
 WHAT ARE THE MANDATORY REQUIREMENTS FOR A
MULTISPECIALITY DENTAL CLINIC?

All the mandatory requirements needed for Stand alone set up applies for
multispeciality Dental Clinic in addition to the following requirements:
3 Dental Chair cum unit
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Dental surgeon incharge with qualification and registration –MDS

For every additional chair area must be increased by 50 %
Adequate space between two dental units
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All instrument and materials for minor periodontal surgery, All material for
oral surgery, like impaction, apicoectomy, implant placement, reduction of
simple fractures
 WHAT ARE THE DESIRABLE REQUIREMENTS FOR A
MULTISPECIALITY DENTAL CLINIC?

Dental X-Ray-RVG/OPG-Own/Outsourced
Receptionist
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Annual Maintenance protocol for equipment and its record

of maintenance
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 WHAT ARE THE MANDATORY REQUIREMENTS FOR A
DENTAL HOSPITAL SET UP?

All the mandatory requirements needed for Stand alone set

up and a Multi Speciality Dental Clinic applies for a Hospital
set up in addition to the following requirements:
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1-5 Dental Chair cum unit

Dental surgeon incharge with qualification and
registration-BDS,MDS
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-THE DESIRABLE REQUIREMENTS ALSO THE SAME AS

MULTI SPECIALITY DENTAL CLINIC REQUIREMENTS
 WHAT IS THE TIME PERIOD TO REGISTER AN
ESTABLISHMENT?

 Existing establishments should register themselves within

9 months.
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 New establishments should register within 6 months.

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 WHEN WILL THE ACT COME INTO FORCE?

From June 1st ,2018

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 HOW AND WHERE TO APPLY FOR REGISTRATION?

 Either in person or by Registered Post with

acknowledgement due to the competent authority
accompanied by a fee for a sum of rupees five thousand
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 WHAT ARE THE DOCUMENTS REQUIRED FOR
REGISTRATION?s

- An application form in the prescribed proforma along with

the prescribed
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 WHAT IS A PROVISIONAL REGISTRATION?

Provisional registration would be provided on ‘as is where is

basis.’ Provisional Registration would be granted within 10
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days of application being filed.

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 PROVISIONAL CERTIFICATE
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 WHAT IS PERMANENT REGISTRATION?

Once minimum standards have been notified by the Govt. for

the Clinical Establishments, Permanent registration would
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be provided to all those conforming to the notified standards

prescribed for that category of clinical establishments
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 WHEN CAN WE RECEIVE THE CERTIFICATE OF
REGISTRATION?

 Within one eighty days from the date of receipt of the

application.
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The Certificate of Registration is non-transferable.

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 WHAT IS THE TIME LIMIT FOR RENEWAL?

Every application for renewal of Certificate of Registration

shall be submitted to the competent authority ninety days
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before the expiry of its validity.

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 CAN WE APPLY FOR A DUPLICATE
CERTIFICATE?

An application for issue of a duplicate Certificate of

Registration shall be made to the competent authority
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accompanied by a fee for a sum of rupees three hundred.

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 WHAT SHOULD WE DO IF WE BUY/HIRE AN ALREADY
REGISTERED CLINICAL ESTABLISHMENT?

Clinical establishment shall inform the authority of such

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change in writing duly signed by both old and new owner.

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 WHAT IS THE PROCEDURE IF THERE IS A CHANGE
IN PESRON INCHARGE?

If no change in category just intimate DRA and correct at the

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time of renewal.
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 WHAT IS THE PROCEDURE TO BE FOLLOWED FOR
SHIFTING A CLINIC TO ANOTHER LOCATION IN THE
SAME DISTRICT?
Certificate in respect of such clinical establishment shall be
surrendered to the authority and Clinical Establishment shall
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apply for registration again

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 WHAT IS THE PROCEDURE TO BE FOLLOWED FOR
UPGRADING A CLINIC?

In case of change of major or broad category the certificate

in respect of such clinical establishment shall be
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surrendered to the authority and Clinical Establishment shall

apply afresh for registration.
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 WHAT IS THE PROCEDURE FOR SHIFTING A
ESTABLISHMENT TO SOME OTHER DISTRICT?

Certificate in respect of such clinical establishment shall be

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surrendered to the authority and apply afresh for

registration.
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Questions asked & documents reqired
• For Pollution control Board:
• Sale deed document
• Auditor certificate
• Biomedical waste management aggrement

1.Authorization
2.consent

• For building approval

• For Building stability
 Uravukku kai koduppom
Urimaiku kural koduppom
Join IDA- strenghthen our fraternity

THANK YOU
dr.selvakumar@hotmail.com
9841295911
 WHAT IS THE CLAUSE NOTED FOR
OPPOSING THE ACT?
Stabilization of patient’s health in Emergency (Chapter I, Clause 2 (d),
(o)) (Chapter III, Clause 12 (2))
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Any patient brought to hospital must be attended. The patient must be

‘stabilized’ before referring to another hospital.
Doctor will be responsible if patient’s condition deteriorates during transit.
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DENTAL CLINIC.-
(1) Building.-The consulting room if it accommodates the Dental Chair also shall be having sufficient
space not less
than 100 square feet. The room shall be well ventilated and shall have sufficient lighting arrangements.
Space
for keeping the Sterilizer and Trays to be provided. Sufficient space for patient waiting to be provided
outside the
consulting room.
(2) Staff.- Dental Surgery, Consultation and prescription shall be performed by a qualified Dental
Surgeon only as per
the Indian Dentist Act, 1948 (Central Act XVI of 1948). Injections and administration of anaesthesia shall
be done
by the dental surgeon himself. X-Ray shall be taken by a qualified Radiographer or by the Dentist.
(3) Equipments.- (a) Dental Chair
(b) Provision of water for surgery
(c) Steriliser
(d) Bin for sterile cotton gauze etc.,
(e) Trays with instruments
(f) Dental instruments
(g) X-Ray (desirable)
(h) Disposable (optional) / autoclaved syringes.
(4) Records.- A record of the patients treated along with name, age, sex, disease and treatment given
shall be available. A slip shall be given to the patient with all the above particulars.
DENTAL HOSPITAL S.-
Out-patient department.- The outpatient department of a dental hospital shall confirm to the norms prescribed to
a Dental
Clinic. In addition, sufficient waiting room shall be provided to the patients. Wards, Operation Theatre and other
aspects shall be
as per the norms prescribed to the nursing homes and hospitals.
CLINICAL LABORATORIES.- They shall include clinical laboratories, pathological laboratories, genetic
laboratories etc.
(1) Building.- A minimum of space for sample collection, First Aid Room, Processing, Report preparation etc., 500
Square
feet in Rural, 700-1500 Square feet in Urban should be available. There shall be lavatories for the patients use at
least one shall
be available with sufficient water. There shall be sufficient space for Microscopy and for Biochemical tests. The room
shall be well
ventilated with sufficient light. Space for keeping a cot for the use of patient shall be available. If x ray is also
functioning norms as
for an X ray centre shall be followed. The laboratories shall ensure adequate space in relation to the following:-
(a) Patient’s reception
(b) S ample collection
(c) Isolation for Bio hazardous materials
(d) Radioisotope related work as per the regulatory agency Atomic Energy Regulatory Board (AERB) requirement.
The Laboratories shall ensure standards prescribed by the National Accreditation Board for Testing and Calibration
of
Laboratories for the personal, qualification etc., Quality assurance in Lab Service, Internal Quality and External
Quality should be
ensured.
(2) Staff.- (a) The Biopsy examination and reporting shall be done by a Pathologist or by a Trained
Doctor. When culture
and sensitivity tests are carried out, a Microbiologist either Medical or non-Medical shall be
available, Cytology reports shall be
given by a Pathologist only.
(b) Qualification for technical staff .- The staff performing the technical tests shall have the
following qualifications,
namely:-
(i) Graduate in Medical laboratory Technology; or
(ii) Two years Diploma course in Medical Laboratory Technology; or
(iii) One year Certificate course in Medical Laboratory Technology with two years experience or
(iv) Graduate in science with one year experience in Medical Laboratory; or
(v) Diploma in medical radiation and radioisotope technology (DM RIT) ; or
(vi) Certificate in Cytotechnology by Indian Academy of Cytology for screening of ex-follative cytology in
addition
to the above qualification for Cytotechnologist.
(c) In a genetic laboratory, all tests shall be carried out and reporting done by a qualified Genetist or
qualified doctor only.
If amniocentesis is done as permitted by law it shall be done only in a Minor Operation Theatre and
all facilities
as needed for a Minor Operation Theatre shall be available and it shall be done by a qualified doctor
under sterile
conditions only.
3. Equipments .-
(a) Microscopes
(b) Calorimeter
(c) Centrifuge
(d) Test Tubes
(e) Slides
(f) Reagent as needed
(g) Semi Auto Analyser or Auto Analyser (Optional)
(h) Cell Counter (Optional)
(i) Haemoglobin meter
(j) Counting Chambers etc.
(k) Refrigerator
(l) Hot Air oven
(m) Physical Balance
(n) Micro Puppets fixed and variable volume.
4. Records.- All tests carried out on the Laboratory
shall be recorded in a Register along with name, age,
sex, investigation
done report, date, etc.,
The following minimum Records to be maintained:-
(a) Daily Results Register
(b) Internal Quality Control Register
(c) S ample Collection Register
(d) Participation in External Quality Assessment
Schemes Programmes.