Clinical Establishment Act Standards for Wellness Centre- Executive Health Checkup

CEA /Wellness Centre- 018

Standard No. CEA/Wellness Centre- 018

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Clinical Establishment Act Standards for Wellness Centre- Executive Health Checkup
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Clinical Establishment
Act Standard for
Wellness Centre- Executive
Health Check up

Standard No. CEA/Wellness Centre- 018

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Introduction
In 2010 Clinical Establishments (Registration and Regulation) Act, 2010 has been
enacted by the Central Government to provide for registration and regulation of all clinical
establishments in the country with a view to prescribe the minimum standards of facilities
and services provided by them.

The Ministry has notified the National Council for Clinical Establishments and The Clinical
Establishments (Central Government) Rules, 2012 under this Act vide Gazette. This Act is
applicable to all kinds of clinical establishments from the public and private sectors, of all
recognized systems of medicine including single doctor clinics. The only exception will be
establishments run by the Armed forces.

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Table of Contents

Sr. No. Particulars Page No.

1. Definition
2. Scope (as applicable)
3. Infrastructure

4. Furniture & Fixture

5. Human Resource

6. Equipment/Instruments/Drugs

7. Drugs and Consumables

8. Support Services
9. Legal/Statutory Requirements

10. Record Maintenance and Reporting

11. Process

12. Glossary

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Wellness Centre-Executive Health Checkup

1. Definition

The standards for wellness centre are framed based on the basic functions of the
unit/centre /provider.

Type of Services Scope of Services

Wellness is a state of optimal health covering physical, mental,

Wellness
social aspects of an individual.

Wellness centre is an healthcare facility that provided

scientifically proven physical interventions with repeatable
positive outcome for improvement or maintenance of physical
Wellness Centre form, enhancement of functions or improvement of beauty (as
define by the customer) for achieving the state of wellness of an
individual. Wellness Centre will address at least two related to
the Structure, Function and Beauty of human beings.

Wellness interventions are those interventions that do not

Wellness require overnight stay at the wellness centre for medical
Interventions reasons; leaving the treatment after any stage should not cause
any harm to the individual.

Centers Executive Health Checkup Centre

2. Scope (as applicable)

2.This includes the services being provided by the facility to which the standards will
be applicable.

2.1. List of services:The scope of services that may be provided at an centre

may include services in any or all of the following specialties, but not necessarily
limited to:

Specific Services under each category to be decided by the centre

Executive Health Checks

1. Laboratory services
2. Imaging services
3. Fitness check
4. Consultation Optional

2.2. List of Support Services:

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2.2.1 Laboratory services to be available either in-house or outside the

centre.

2.2.2 Imaging services to be available either in-house or outside the centre.

Sr. no. Support Service Applicability

1. Accounting, Optional
2. Billing Applicable
3. Essential commodities like water Applicable
supply, electric supply etc.
4. Finance Optional
5. Financial accounting and auditing As required by Law
6. Housekeeping and Sanitation Applicable
7. Inventory Management Optional
8. Laundry services Optional
9. Medical records Applicable
10. Office Management (Provision should Applicable
be made for computerized medical
records with anti-virus facilities
whereas alternate records should also
be maintained)
11. Personnel Department Optional
12. Pharmacy/ Dispensary Optional
13. Purchase Applicable
14. Reception, Applicable
15. Security services Optional
16. Stores Optional
17. Waste management Housekeeping/ Applicable
sanitation,
18. Equipment Management Applicable

3. Infrastructure Requirements

3.1 Basic signage- A signage within or outside the facility shall be made available
containing the following information.

3.1.1 A signage within or outside the facility should be made available

containing the following information.

3.1.2 *All signage meant for customer and visitors shall be bilingual Local
language and Hindi / English

3.2 Following Informative signage shall be displayed:

3.2.1 Name of the care provider with registration number

3.2.2 Name of organization.

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3.2.3 Display of Registration under clinical establishment act

3.2.4 Fee structure,

3.2.5 Availability of tariff list.

3.2.6 Timings of the facility

3.2.7 Availability of timings with names and respective specializations

3.2.8 Services provided

3.2.9 Directional signage for customers for utilities and conveniences like
toilets, drinking water, telephone booths, shops.

3.2.10 Display of Executive Health checks centre scope of services

3.2.11 Floor Plan With Location Of Departments

3.2.12 Plan of Facility, if stand-alone building.

3.3 Following Safety signage shall be displayed:

3.3.1 Safety Hazard and Caution signs

3.3.2 Display of all radiation hazard signage in radiation areas (if applicable).

3.3.3 Display of Biomedical waste segregation at all location where BMW bins
are kept

3.3.4 Display of danger signage at all electric panels and other dangerous
areas

3.3.5 Display of General instructions like No Smoking, Keep Silence, Use

dustbin, etc. at various customer and visitor areas in the hospital

3.3.6 Display of hand--washing techniques compliant with WHO guidelines at

all hand wash basins

3.3.7 Display of important phone contact numbers of hospital authorities

3.3.8 Displays required by regulations like PNDT, Lifts, Fire, etc.

3.3.9 Display of Material Safety Data Sheet at all locations where Hazardous
Materials are stored

3.3.10 Display of customer rights and responsibilities

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3.3.11 Display of safety instructions in areas where any kind of safety hazard
may be expected. This includes areas like transformers, Cylinder storage,
LPG storage etc

3.3.12 Hazards- electrical, fall, pipe locations, prohibited areas

3.3.13 Notice board for general information to staff

3.3.14 Notice board in front of all customer

3.3.15 Routes for all areas

3.3.16 Signage for parking. (Signage for ambulance parking shall be separately
mentioned)

3.3.17 Appropriate Fire exit signages

3.3.18 Display of how to use fire extinguisher at all point where fire extinguisher
is installed

3.3.19 Emergency exit signage (preferably in auto illumination material, like

radium)

3.3.20 Safety signage will be displays as per the requirements of respective

Indian Standards: Ex. Fire Protection Safety Signs IS 12349:1988

3.4. Functional space planning of the facility like reception area, waiting area should
be as per the scope of services.

3.4.1 Consultation & examination room

i. Consultation room should be adequate to accommodate:
ii. Table for Consultancy
iii. Consultation chair,
iv. Two stools/ chairs,
v. Examination bed, if necessary, will be of the size 6 ft X 2.5 ft.,
vi. Privacy screen around examination area while having free mobility

3.4.2 Laundry (optional)

i. Laundry services can be in-house or outsourced.

ii. If it is provided in house, it should have necessary facilities for drying,
pressing and storage of soiled and cleaned linens.
iii. If outsourced, quality of outsourced work is monitored by the organization.

3.4.3 House-Keeping:

i. Housekeeping services should be made available for effective cleanliness.

ii. Housekeeping services can be outsourced.

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iii. A designated area within functional areas for safe storage of housekeeping
materials has to be in centre.

3.4.4 Security Services:

i. There is a designated location for security staff on duty.

3.4.5 Clinical laboratory specifications:

i. Laboratory services to be available either in-house or outside the Hospital.for

quick diagnosis of blood, urine, etc.,

3.4.6 Radiology section

i. Imaging services to be available either in-house or outside the Hospital.

ii. The department should be located at a place which is accessible to
customers.
iii. The size of the room should depend on the type of instrument installed.
iv. It should confirm to AERB requirements.
v. The room should have a sub-waiting area with toilet facility and a change
room facility, if required.
vi. Film developing and processing (dark room) shall be provided in the
department for loading, unloading, developing and processing of X-ray films.
vii. Separate Reporting Room for doctors should be provided.

3.4.7 Customer / Medical record-room:

i. Customer /Medical record-storage should be of adequate size as per the load

of the documents of the centre.
ii. Tamperproof material and locking facility Cabinets/ cupboards/ Boxes will be
used.
iii. Fire extinguishers of correct type should be made available nearby all
locations.

3.4.8 Store rooms:

i. Store room should be lockable & of adequate size with exhaust fan.
ii. Area should be clean, well ventilated, well lit, without any dampness or fungal
growth on walls.

3.4.9 Duty rooms for doctors

i. To accommodate 1 bed of 6 feet X 3 feet and a side table.

ii. Separate beds if sharing for same gender.
iii. Separate rooms for separate genders will be provided.

3.4.10 Duty rooms for technicians:

i. To accommodate 1 bed of 6 feet X 3 feet and a side table.

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ii. Separate beds if sharing for same gender.

iii. Separate rooms for separate genders will be provided.

3.4.11 Dirty utility room:

i. Separate area of minimum 15 sq feet.

4. Furniture &Fixtures

4.1 Furniture and fixtures shall be available in accordance with the services and
workload of the centre. For indicative list refer to Annexure 1.

4.2 The furniture and fixtures shall be functional all the time.

5. Human Resource

5.1 A suitably qualified and individual heads the organization and manages in
ethical manner. For detail refer to Annexure 2.

5.2 The technical staff employed should have the relevant education / registration,
training and experience to provide service to customer care without
supervision.

5.3 The additional staff member shall be adequately trained on specific job duties
or responsibilities related to customer safety and well being.

5.4 Personnel record containing personal and professional information shall be

maintained for each staff.

5.5 Periodic skill enhancement/up gradation /refresher trainings shall be provided

for all categories of the staff relevant to their job profile.

6. Equipment/Instruments

6.1 The centre shall have equipments / instruments as per the scope of services
provided. For indicative list refer to Annexure 3

6.2 Adequate space for placement and usage of equipments and Instruments
shall be provided.

6.3 The equipment should be of adequate capacity to meet work load

requirement.

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6.4 All equipment should be in good working condition at all times. Periodic
inspection, cleaning, maintenance of equipment should be done.

7. Drugs and Consumables

7.1 Drugs and consumables as per the scope of services provided. For indicative
list refer to Annexure 4.

7.2 Storage of drugs, cosmetic and consumables shall be stored as per

manufacturers guidelines.

7.3 The drugs are handled by appropriate personnel in accordance of the

regional, local and national regulations.

For Legal requirement refer to Annexure 4

For record maintenance refer to Annexure 5

OTHER REQUIREMENTS AS PER STANDARD NO. CEA-NABH /WELLNESS

CENTRE- 017SHALL ALSO BE COMPLIED WITH.

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Annexure 1

Furniture/fixture

I. Furniture/Fixture Requirements: as per the scope of services

Sr. No. Name of the Equipment Executive Health checks Centre
1. Adequate lockable storage
As per requirement
space
2. Air conditioning As per requirement
3. An examination table of 6 ft. X As per requirement
2.5 ft. With privacy screen
4. Blood pressure apparatus 1 per Centre
5. Ceiling Fans As per requirement
6. Clock 1 per Centre 1 per Centre
7. Computers 1 per Centre
(if required)
8. Consultants chair As needed
9. Consultants or Office table 1 per Centre
10. Duty table for staff 1 per Centre
11. Emergency resuscitation kit 1 per Centre
12. Essential diagnostic tools
required for examination of
As per requirement
customer as per the scope of
services offered by the Centre.
13. Fire extinguisher ABC 1 per ward/ floor based on layout
14. Foot stools 1 per consultation room
15. Heavy duty Torch light 1 per Centre
16. Hot Water Bags As per requirement
17. Hot Water geyser As per requirement
18. Light source which gives light
colour and temperature similar
to solar light, As per requirement
Light intensity of at least 500
lux at the point of examination.
19. Office chairs 1 per Centre
20. Customer locker 1 per Centre
21. Refrigerator if temperature 1 per Centre
sensitive medication are
stored (if required)
22. Steel or Wooden cup board As per requirement
23. Steel rack As per requirement
24. Stethoscope 1 per Centre
25. Stools As per requirement

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26. Stools revolving 2 per Centre

27. Hammock Stretcher/ 1 per Centre
Stretcher/ Customer trolley
1 per Centre
28. Telephone/ Fax equipment As per requirement
29. Thermometer 1 per Centre
30. Waiting chairs / benches for 50% of the customer strengths
customers relatives
31. Weighing machine 1 per Centre
32. Wheel chair 1 per Centre
33. X-ray viewer 1 per Centre

II. Other Furniture/Fixture Requirements

Sr. No. Name of the Equipment Executive Health checks Centre

1. Air conditioners Central A/C As per requirement

2. Computer with modem with UPS, As needed
printer with internet connection
3. Coolers As needed
4. Drinking Water purifier As needed
5. Emergency lamp 2 Per Area/ Ward
6. Exhaust Fan As needed
7. Fire extinguishers As needed
8. Geyser 1 per ward
9. Refrigerator 1 per ward
10. Tables & Chairs As needed
11. Telephone/ cell phone 1 per ward
12. Tube lights As needed
13. Vacuum cleaner As needed
14. Computer with Modem with UPS, As needed
Printer with Internet Connection
15. Xerox Machine As needed
16. Intercom (10 lines) As needed
17. Fax Machine As needed

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Annexure 2

Human Resource Requirement

1. This includes the Designation, minimum qualification & number of people
required in the facilityas per the scope of services.

1.1Medical practitioners

1. Category: MBBS Doctors.

2. Minimum Qualifications: Degree/ Post Graduate Degree from recognized
university Registration: (if applicable): with state or central council of related
to the profession.
3. Trained / skilled: Trained

Sr. no. Executive Health Checks

1. As per Allopathy standards in relevant specialties as the profile of
checkup provided at the centre

1.2Nurses:
ANM/ GNM/ BSc/MSc nurses,
One per shift per for 50% of the total number of consulting room

1.3Paramedics

1. Category:Paramedics
2. Minimum Qualifications: (diploma/degree from recognized university.)
3. Registration with the concerned council(if applicable): state or central
council
4. Trained / skilled: Trained

Sr. no Paramedics Minimum qualification Executive

Health Checks
1. ECG Technician As per
1 year experience of
(if ECG services are requirement
taking ECG
provided in-house)
2. As per
Laboratory Attendant Ability to read national or
(if lab is in-house) local language requirement

3. Qualified Laboratory As per

Laboratory Technician
Technician requirement
(if Lab is in-house)
4. Minimum qualification- As per
Medical Records
12th Standard passed. requirement
Officer / Technician
5. As per
Radiographer
Qualified Radiographer requirement
(if Imaging is in-house)

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6. As per
Ward Ayah Eight standard completed
requirement
7. As per
Ward boy Eight standard completed
requirement

1.4. Administrative staff: The number would vary as per scope of the centre/
requirement and may be outsourced.

Administrative staff
Sr. no Administrative staff Executive Health Checks

1. As per requirement
Office Administrator
2. As per requirement
Accountant
3. As per requirement
Multi purpose worker

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Annexure 3

Equipment/Instrument

Following emergency equipment shall be available as follows:

Sr. No. Emergency Equipment Executive Health

Checks Centre

1. Emergency equipment box for first aid & Minimum 1

BLSS
2. Crash-Cart trolley:1 Minimum 1
3. Portable defibrillator:1 Optional
4. Disposable syringes As needed
5. Ambu Bag:1 Minimum 1
6. Laryngoscope with cells & adult and Minimum 1
pediatric blades
7. Sealed battery cell Minimum 1
8. Endotracheal tubes As needed
9. Pulse Oxymeter Minimum 1
10. Suction Apparatus Minimum 1
11. ECG Machine Minimum 1
12. BP Apparatus & Stethoscope Minimum 1
13. Oxygen cylinders with flow meter/ Minimum 1
tubing/catheter/face mask/nasal prongs

Other necessary and sterilizing equipment as per the scope of services shall
also be available.

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Annexure 3

Drugs, Medical devices and Consumables

I. Emergency drugs:

Category:Emergency Drugs
Sr. no. Name of the Drug Strength Minimum Quantity
1. Inj. Adrenaline As per I.P. Minimum 10 Ampoules/ Vials
2. Inj. Atropine As per I.P. Minimum 10 Ampoules/ Vials
3. Inj. Calcium Carbonate As per I.P. Minimum 10 Ampoules/ Vials
4. Inj. Dopamine As per I.P. Minimum 10 Ampoules/ Vials
5. Inj. Dobutamine As per I.P. Minimum 10 Ampoules/ Vials
6. Inj. Nitroglycerine As per I.P. Minimum 10 Ampoules/ Vials
7. Inj. Sodium Bicarbonate As per I.P. Minimum 10 Ampoules/ Vials
8. Inj. Hydrocortisone As per I.P. Minimum 10 Ampoules/ Vials
9. Inhaler Beclomethasone (250 As per I.P. Minimum 10 Ampoules/ Vials
micro/dose)
10. Inhaler Salbutamol (200 As per I.P. Minimum 10 Ampoules/ Vials
micrograms)
11. Inj. Frusemide As per I.P. Minimum 10 Ampoules/ Vials
12. Inj. Diazepam/Midazolam As per I.P. Minimum 10 Ampoules/ Vials
13. Inj. Deriphyllin As per I.P. Minimum 10 Ampoules/ Vials
14. Inj. Phenytoin sodium As per I.P. Minimum 10 Ampoules/ Vials
15. Inj. Avil As per I.P. Minimum 10 Ampoules/ Vials
16. Inj. Ondansetrone As per I.P. Minimum 10 Ampoules/ Vials
17. Inj. KCl As per I.P. Minimum 10 Ampoules/ Vials
18. Inj. Lignocaine 2% As per I.P. Minimum 10 Ampoules/ Vials
19. Inj. Amiadarone As per I.P. Minimum 10 Ampoules/ Vials
20. Inj. Magnesium sulphate As per I.P. Minimum 10 Ampoules/ Vials
21. Inj. Mannitol As per I.P. Minimum 10 Ampoules/ Vials
22. Inj. Morphine/Inj. Pethidine As per I.P. Minimum 10 Ampoules/ Vials
23. Inj. Noradrenaline bititrate As per I.P. Minimum 10 Ampoules/ Vials
24. Inj. Fentanyl As per I.P. Minimum 10 Ampoules/ Vials
25. water for Injection As per I.P. Minimum 10 Ampoules/ Vials
26. Inj. Sodium Valporate As per I.P. Minimum 10 Ampoules/ Vials
27. Inj. Voveran As per I.P. Minimum 10 Ampoules/ Vials
28. Inj. Paracetamol As per I.P. Minimum 10 Ampoules/ Vials
29. Mannitol Injection As per I.P. Minimum 10 Ampoules/ Vials
30. Metoprolol Injection As per I.P. Minimum 10 Ampoules/ Vials
31. N/2 saline Injection As per I.P. Minimum 10 Ampoules/ Vials
32. Oxygen Inhalation As per I.P. Minimum 10 Ampoules/ Vials
33. Oxytocin Injection As per I.P. Minimum 10 Ampoules/ Vials

II. Disinfectants: As applicable in adequate quantity

Sr. no Disinfectants
1. Hypochlorite 4%-6%
2. Ortho-phthalaldehyde (OPA)
3. 70% ethanol plus10ppm Bitrex
4. Formaldehyde solutions (1%2%)

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5. Glutaraldehyde
6. Hydrogen peroxide
7. Quaternary ammonium compounds
8. Phenolic germicides

III. Linen

Sr. no Linen Quantity

1. Bed sheets As per requirement

2. Bedspreads As per requirement

3. Blankets one per bed

4. Curtain cloth windows and As per requirement
doors
5. Overcoat for consultant one per consultant
6. Mats (Nylon) As per requirement

7. Mattress (foam) adults As per requirement

8. Pediatric Mattress one per bed

9. towels As per requirement

10. Pillow covers As per requirement

11. Pillows As per requirement

12. Table cloth adequate quantity

13. Uniform / Apron As per requirement

IV. Stationary as per the scope of services

Sr. no. Items
1. Consents Forms
2. Consultant Reference Form
3. Continuation sheets
4. Diet Sheets
5. Initial Assessment Form
6. Pathological Books
7. Registers
8. Registration Card
9. Sentinel Event Form
10. Supplementary Sheets
11. X-ray Forms

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Annexure 4

Legal/Statutory Requirements

This includes the minimum statutory compliance applicable as per the central or
state government along with licensing body, wherever applicable.

Sr. no. Name of the Act Department/Area Licensing body

1. Registration under Shops Organization Jurisdictional
and Establishment Act Authorities like
Panchayat/
Nagarpalika/
Mahanagarpalika/
Municipality/ Municipal
Corporation

2. Registration under Clinical Organization Jurisdictional

Establishment Act Authorities like
Panchayat/
Nagarpalika/
Mahanagarpalika/
Municipality/ Municipal
Corporation

3. Agreement for Common Organization Local Pollution Control

Biomedical Waste Collection, Board
Transportation, Treatment,
Storage and Disposal
Facility
4. Registration under Air Organization Local Pollution Control
(prevention and control of Board
pollution) Act, 1981.
5. Building Permit (From the To be obtained Jurisdictional Revenue
Municipality). from Authorities like
Panchayat/
Nagarpalika/
Mahanagarpalika/
Municipality/ Municipal
Corporation
6. Certificate u/s 80-G of IT Act Organization If applicable.
7. ESIS registration in case of Organization Employee State
>20 employees Insurance Company
8. Excise permit to store Spirit. Organization Excise department
9. Generator Exhaust air Generator Authorized Air Testing
Quality Report Laboratory
10. License to sale or distribute Pharmacy FDA
drugs Form 20, 21, 21C
11. License for lift Lift Mobile Electric

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Vehicles Department
12. License to play music for Organization Indian
public use
13. No objection certificate from Organization Fire Department
the Chief Fire Officer.
14. Obtaining clearances for Weights and Department of Weights
weighing equipments in all measures and Measures
the centre units under The
Standards of Weights and
Measures Act, 1976.
15. Occupation Certificate To be obtained Jurisdictional Revenue
from Authorities like
Panchayat/
Nagarpalika/
Mahanagarpalika/
Municipality/ Municipal
Corporation
16. PNDT Act, 1996. Sonography Health Department of
Regulatory Body
assigned with the
responsibility
17. SMPV License for Storage of Medical Gases Licensing Authority
Liquid Oxygen, Form III in Pressurized
(License to compressed gas Vessels
in pressure vessel or
vessels)
18. TAN Number Organization Income Tax
Department
19. PAN Number Organization Income Tax
Department
20. Vehicle Registration Ambulance and Road Traffic Authority
certificates for Ambulance Vehicles owned
by the
organization
21. Water Prevention and Organization Pollution Control Board
control of pollution Act

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Annexure 5

Record Maintenance and reporting

1. Standard on record maintenance

Sr. no Records
1. Customer Records
2. Customer reports records
3. Reports of investigations
4. Consents

2. Standard on content of medical record.

Sr. no. Name Of Forms

1. Customer Registration Details
2. Consent
Initial Assessment Record including Pain Assessment and
3.
Nutritional screening
4. Advise or Treatment record
5. Imaging Report Format for each imaging modality
6. Laboratory Report Forms for each category of investigation

3. Standard on reporting of various notifiable diseases as per scope of

services of Clinical establishment
As per scope of services or by the scope of concerned government/ municipal
department

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