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FORTIS HEALTHCARE LIMITED P age 1 o f

80
Standard Operating Procedure for

Bio Medical Waste Management

STANDARD OPERATING
PROCEDURE

BIO MEDICAL WASTE


MANAGEMENT

SOP BMW-P-2016-1.1
Number:
Version 1.1 Effective 1st July Supersedes BMW-P- Next 31st
Number: Date: 2016 Version: 2016-1.0 Review March
Date: 2017
Prepared Dr Ravneet Reviewe Dr Approved Dr Bishnu Panigrahi
By: Kaur, d By: Akash By:
Dr Anita Sud
Arora,
Dr Anita
Sharma

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Standard Operating Procedure for

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Table of Contents
S. No. Section Page
I Change Control Information 4
II Functional Organizational Structure 5
III Scope & Objectives 6
IV Common Abbreviations 7
V Definitions 8
VI Involved Personnel (Roles & Responsibilities) 9
VII Flowchart 10
VIII Process 10
01. Duties of the Occupier 11

02. Bio-Medical Waste Management 15

03. Segregation Of Waste 24

04. Waste Removal & Transportation 26

05. Treatment and Disposal 28

06. Waste Storage & Transportation to Waste Treatment Facility 32

07. Licensing & Other requirements for Bio-medical Waste 34


management
08. Minimum terms of Service Level Agreement with the Vendor 40

09. Biomedical Waste Audit 42

Annex 1 Labels for Biomedical waste containers/bags 44


Annex 2 Labels for transport of Biomedical waste containers/bags 45
Annex 3 Standards for treatment and disposal of Biomedical waste 46

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S. No. Section Page


Annex 4 Bio Medical Waste Record 56
Annex 5 Application for Authorization 57
Annex 6 Authorisation 61
Annex 7 Annual Report 63
Annex 8 Accident Reporting 68
Annex 9 Biomedical Waste Audit Sheet 69

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I. Change Control Information

Version 1.1 Effective 1st July Supersedes BMW-P- Next


Number: Date: 2016 Version: 2016-1.0 Review
Date:
Changes Reason for Adding Interpretations received from
Made: change: CPCB Dt 08/06/2016

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II. Functional Organizational Structure (Organogram)


(TO BE DEVELOPED BY FACILITY)

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III. Scope and Objectives of process

The goal of the department is... To ensure that biomedical waste is handled and
disposed in a safe manner

The scope and complexity of services Biomedical waste is generated in all patient care
provided by this department is... areas and needs to be managed as per the
applicable statutory regulations

The methods used in order to customize Biomedical waste segregation


services are....
Biomedical waste storage till transportation to
final treatment/disposal site

The extent to which the level of care/ Color coded waste disposal bags are
services provided meets customer needs are: conveniently available at waste generation sites.
Waste is stored and transported in closed
bags/bins to central area where it is kept till
collected for final disposal.

Regulatory agencies relevant to this State Pollution Control Board


service…

Staffing plan is... Supervisor – 1

GDA/Housekeeping - as required

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IV. Common Abbreviations

Sl. Abbreviation Full Form


No.
1 Listed in each process

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V. Definitions
Sl. Term Definition
No.

1 Authorised "authorised person" means an occupier or operator authorised by the


Person prescribed authority to generate, collect, receive, store, transport, treat,
process, dispose or handle bio-medical waste in accordance with these
rules and the guidelines issued by the Central Government or the Central
Pollution Control Board, as the case may be.

2 Bio-medical "bio-medical waste" means any waste, which is generated during the
Waste diagnosis, treatment or immunisation of human beings or animals or
research activities pertaining thereto or in the production or testing of
biological or in health camps, including the categories mentioned in
Schedule I appended to these rules.

3 Handling handling in relation to bio-medical waste includes the generation, sorting,


segregation, collection, use, storage, packaging, loading, transportation,
unloading, processing, treatment, destruction, conversion, or offering for
sale, transfer, disposal of such waste.

4 Major Major Accident means accident occurring while handling of bio-medical


Accident waste having potential to affect large masses of public and includes
toppling of the truck carrying bio-medical waste, accidental release of
bio-medical waste in any water body but exclude accidents like needle
prick injuries, mercury spills.

5 Management “management” includes all steps required to ensure that bio- medical
waste is managed in such a manner as to protect health and environment
against any adverse effects due to handling of such waste.

6 Occupier Occupier means a person having administrative control over the


institution and the premises generating bio-medical waste, which includes
a hospital, nursing home, clinic, dispensary, veterinary institution, animal
house, pathological laboratory, blood bank, health care facility and
clinical establishment, irrespective of their system of medicine and by
whatever name they are called.

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VI. Involved Personnel (Roles & Responsibilities)

Sl. Process Functional Responsibility Charge


No.

1 Segregation of Waste Doctors, Nurses, Technicians, GDAs MS, CoN


at source (including all employees involved in
generation & segregation of BMW)

2 Transport to temporary Housekeeping Head – Admin


Storage Area

3 Transport to Central Housekeeping Head – Admin


Garbage Area

4 Storage and Handover Housekeeping, Security Head – Admin


to Collecting Agency

5 Timely Submission of Housekeeping/Administration Head – Admin


Reports to Authorities

6 Licensing Administration Head – Admin

7 Display on Website Housekeeping, Marketing Head – Admin,


Head - Marketing

8 Oversight Infection Control Committee Chairman, Infection


Control Officer, MS,
CoN, Head Admin

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VII. Flowchart – NA

VIII. Process

1. Duties of the Occupier

2. Bio-Medical Waste Management

3. Segregation of Waste

4. Waste Removal & Transportation

5. Treatment and Disposal

6. Waste storage & Transportation to Waste Treatment Facility

7. Licensing and other requirement for Bio-medical Waste Management

8. Minimum terms of Service Level Agreement with the Vendor

9. Biomedical Waste Audit

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DOCUMENT IS BASED ON BIOMEDICAL WASTE MANAGEMENT RULES (2016)


# All Interpretations based on clarifications received in meeting with CPCB dt 08/06/2016

Biomedical Waste Management

BMW / SOP No. 01

________________________________________________________________

Title: Duties of the Occupier

It shall be the duty of every occupier to-

(a) take all necessary steps to ensure that bio-medical waste is handled without any adverse
effect to human health and the environment and in accordance with these rules

(b) make a provision within the premises for a safe, ventilated and secured location for
storage of segregated biomedical waste in coloured bags or containers in the manner as
specified in Table I, to ensure that there shall be no secondary handling, pilferage of
recyclables or inadvertent scattering or spillage by animals and the bio-medical waste
from such place or premises shall be directly transported in the manner as prescribed in
these rules to the common bio-medical waste treatment facility or for the appropriate
treatment and disposal, as the case may be, in the manner as prescribed in Table 1;

(c) pre-treat the laboratory waste, microbiological waste, blood samples and blood bags
through disinfection or sterilisation on-site in the manner as prescribed by the World
Health Organisation (WHO) or National AIDs Control Organisation (NACO) guidelines
and then sent to the common bio-medical waste treatment facility for final disposal;
#
Interpretation - The Pre-treatment can be done by Autoclaving

(d) phase out use of chlorinated plastic bags, gloves and blood bags within two years from
the date of notification of Bio-Medical Waste Management Rules, 2016; (i. e. latest by
27th March 2018).

(e) not to give treated bio-medical waste with municipal solid waste;

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(f) provide training to all its health care workers and others, involved in handling of bio
medical waste at the time of induction and thereafter at least once every year and the
details of training programmes conducted, number of personnel trained and number of
personnel not undergone any training shall be provided in the Annual Report;

(g) immunise all its health care workers and others, involved in handling of bio-medical
waste for protection against diseases including Hepatitis B and Tetanus that are likely to
be transmitted by handling of bio-medical waste.

(h) establish a Bar- Code System for bags or containers containing bio-medical waste to be
sent out of the premises or place for any purpose within one year from the date of the
notification of Bio-Medical Waste Management Rules, 2016. (i. e. latest by 27th March
2017).
#
Interpretation – The Bar Codes to be affixed on the BMW Bags at the Central BMW Storage
area before the Bags leave the Hospital.

(i) ensure segregation of liquid chemical waste at source and ensure pre-treatment or
neutralisation prior to mixing with other effluent generated from health care facilities;
#
Interpretation - The Liquid Chemical Waste can be either neutralized or Pre-treated in a
Pretreatment tank (which may even be Benchtop) before mixing with other effluent. This is
applicable to situations where the hospital is discarding liquid chemicals containing acids or
alkalis, which should be then be neutralized, prior to mixing with other effluent from the
Hospital.

(j) ensure treatment and disposal of liquid waste in accordance with the Water (Prevention
and Control of Pollution) Act, 1974 ( 6 of 1974);

(k) ensure occupational safety of all its health care workers and others involved in handling
of bio-medical waste by providing appropriate and adequate personal protective
equipments;

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(l) conduct health check up at the time of induction and at least once in a year for all its
health care workers and others involved in handling of bio- medical waste and maintain
the records for the same;
#
Interpretation -The actual records of the Health Check up may or may not be preserved, but a
Log Book of the Health Check Ups conducted is to be preserved for 5 years

(m) maintain and update on day to day basis the bio-medical waste management register and
display the monthly record on its website according to the bio-medical waste generated in
terms of category and colour coding as specified in Table 1;

(n) report major accidents including accidents caused by fire hazards, blasts during handling
of bio-medical waste and the remedial action taken and the records relevant thereto,
(including nil report) in Form I to the prescribed authority, and also along with the annual
report;
#
Interpretation – The Nil Report has to be submitted only along with the Annual Report in case
there is no Accident throughout the year

(o) make available the annual report on its web-site and all the health care facilities shall
make own website within two years from the date of notification of Bio-Medical Waste
Management Rules, 2016; (i. e. latest by 27th March 2018 for Hospitals which do not
already have a Website).

(p) inform the prescribed authority immediately in case the operator of a facility does not
collect the bio-medical waste within the intended time or as per the agreed time;
#
Interpretation – inform the prescribed authority immediately in case the operator of a facility
does not collect the bio-medical waste within 48 Hrs.

(q) establish a system to review and monitor the activities related to bio-medical waste
management, either through Infection Control Committee (Quarterly) or by forming a
new committee and the new Committee shall meet once in every six months, The record
of the minutes of the meetings of Infection Control Committee (Quarterly) or the new
Committee shall be submitted along with the annual report to the prescribed authority and
the healthcare establishments having less than thirty beds shall designate a qualified
person to review and monitor the activities relating to bio-medical waste management
within that establishment and submit the annual report;

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(r) maintain all record for operation of incineration, hydro or autoclaving etc., for a period of
five years;
#
Interpretation – Log Book for Hydro or Autoclaving is to be maintained for 5 years

(s) existing incinerators (where applicable) to achieve the standards for treatment and
disposal of bio-medical waste as specified in Annexure 3, for retention time in secondary
chamber and Dioxin and Furans within two years from the date of this notification. (i. e.
latest by 27th March 2018).

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Biomedical Waste Management

BMW / SOP No. 02


________________________________________________________________

Title: Biomedical Waste Management

Objective: To provide guidelines for management of Bio-medical waste.

Job Responsibility: As per section on Roles & Responsibilities

Purpose: To define the guidelines for segregation, handling, storage, transportation and disposal
of various kinds of biomedical waste.

Scope: This SOP applies to all employees who generate, collect, receive, store, transport, treat,
dispose, or handle bio medical waste in any form. The scope of this SOP applies to biomedical
waste only.

Bio-medical waste means any waste, which is generated during the diagnosis, treatment or
immunization of human beings or animals or in research activities pertaining thereto or in the
production or testing of biologicals, and including categories mentioned in Table 1.

Table 1: Categories of Biomedical waste

#
Category Type of Waste Type of Bag Treatment and Interpretation
or Disposal options
Container
to be Used

(1) (2) (3) (4) (5)

Yellow (a) Human Anatomical Yellow Incineration or Plasma No Pre-


Waste: Human tissues, coloured Pyrolysis or deep treatment
organs, body parts and non- burial* required to be
foetus below the chlorinated done in the
viability period (as per plastic bags hospital.
the Medical
Termination of

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#
Category Type of Waste Type of Bag Treatment and Interpretation
or Disposal options
Container
to be Used

(1) (2) (3) (4) (5)

Pregnancy Act 1971,


amended from time to
time).

(b) Animal Anatomical


Waste : Experimental
animal carcasses, body
parts, organs, tissues,
including the waste
generated from animals
used in experiments or
testing in veterinary
hospitals or colleges or
animal houses.

(c) Soiled Waste: Items Incineration or Plasma No Pre-


contaminated with Pyrolysis or deep treatment
blood, body fluids like burial* required to be
dressings, plaster casts, done in the
cotton swabs and bags In absence of above hospital, except
containing residual or facilities, autoclaving for Blood Bags
discarded blood and or micro-waving/ which need to be
blood components. hydroclaving followed Autoclaved.
by shredding or
mutilation or
combination of
sterilization and
shredding. Treated
waste to be sent for
energy recovery.

(d) Expired or Discarded Yellow Expired `cytotoxic Cytotoxic drugs


Medicines: coloured drugs and items & items
Pharmaceutical waste non- contaminated with contaminated
like antibiotics, chlorinated cytotoxic drugs to be with cytotoxic
cytotoxic drugs plastic bags returned back to the drugs to be put
including all items or containers manufacturer or in Yellow Bag
contaminated with supplier for with Cytotoxic
cytotoxic drugs along incineration at Hazard Symbol.

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#
Category Type of Waste Type of Bag Treatment and Interpretation
or Disposal options
Container
to be Used

(1) (2) (3) (4) (5)

with glass or plastic temperature >1200 0C Sharps


ampoules, vials etc. or to common bio- contaminated
medical waste with Cytotoxic
treatment facility or Drugs to be put
hazardous waste in a puncture
treatment, storage and Proof Box
disposal facility for (Cardboard etc )
incineration at before putting in
>12000C Or Yellow Bag.
Encapsulation or Cytotoxic &
Plasma Pyrolysis at Pharmaceutical
>12000C. Waste can be
handed over to
All other discarded the operator of
medicines shall be common Bio-
either sent back to medical Waste
manufacturer or treatment
disposed by facility.
incineration.

(e) Chemical Waste: Yellow Disposed of by No Pre-


Chemicals used in coloured incineration or Plasma treatment
production of biological containers or Pyrolysis or required to be
and used or discarded non- Encapsulation in done in the
disinfectants chlorinated hazardous waste hospital.
plastic bags treatment, storage and
disposal facility.

(f) Chemical Liquid Separate After resource Separate


Waste: Liquid waste collection recovery, the chemical collection
generated due to use of system liquid waste shall be system leading
chemicals in production leading to pre-treated before to effluent /
of biological and used effluent mixing with other sewage
or discarded treatment wastewater. The treatment system
disinfectants, Silver X- system combined discharge The combined
ray film developing shall conform to the discharge shall
liquid, discarded discharge norms given conform to the
Formalin, infected discharge norms

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#
Category Type of Waste Type of Bag Treatment and Interpretation
or Disposal options
Container
to be Used

(1) (2) (3) (4) (5)

secretions, aspirated in Schedule- III. given in


body fluids, liquid from Schedule - II, to
laboratories and floor be ascertained
washings, cleaning, by the
housekeeping and Prescribed
disinfecting activities authorities.
etc.

(g) Discarded linen, Non- Non- chlorinated No Pre-


mattresses, beddings chlorinated chemical disinfection treatment,
contaminated with yellow followed by shredding/
blood or body fluid. plastic bags incineration or Plazma mutilation
or suitable Pyrolysis or for energy required to be
packing recovery. done in the
material hospital
In absence of above Discarded linen,
facilities, shredding or mattresses,
mutilation or beddings
combination of contaminated
sterilization and with blood or
shredding. Treated body fluid to be
waste to be sent for put in Non-
energy recovery or chlorinated
incineration or Plasma yellow plastic
Pyrolysis. bags or suitable
packing material
and Labeled
with a Label
mentioning the
contents.
(h) Microbiology, Autoclave Pre-treat to sterilize To be put in a
Biotechnology and safe plastic with non-chlorinated Autoclave Safe
other clinical bags or chemicals on-site as Bag (any
laboratory waste: containers. per National AIDS Colour)
Blood bags, Laboratory Control Organisation Autoclaved &
cultures, stocks or or World Health then put in a
specimens of Organisation guidelines Yellow Bag and
microorganisms, live or thereafter for handed over to

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#
Category Type of Waste Type of Bag Treatment and Interpretation
or Disposal options
Container
to be Used

(1) (2) (3) (4) (5)

attenuated vaccines, Incineration. the operator of


human and animal cell common Bio-
cultures used in medical Waste
research, industrial treatment
laboratories, production facility.
of biological, residual
toxins, dishes and
devices used for
cultures.

Red Contaminated Waste Red Autoclaving or micro- No Pre-


(Recyclable) coloured waving/ hydroclaving treatment,
non- followed by shredding shredding/
(a) Wastes generated from chlorinated or mutilation or mutilation
disposable items such as plastic bags combination of required to be
tubing, bottles, or containers sterilization and done by the
intravenous tubes and shredding. Treated hospital if
sets, catheters, urine waste to be sent to handing over to
bags, syringes (without registered or authorized the operator of
needles and fixed needle recyclers or for energy common Bio-
syringes) and recovery or plastics to medical Waste
vacutainers with their diesel or fuel oil or for treatment
needles cut) and gloves. road making, facility.
whichever is possible. Autoclaving or
micro-waving/
Plastic waste should hydroclaving
not be sent to landfill followed by
sites. shredding or
mutilation or
combination of
sterilization and
shredding to be
done by the
operator of
common Bio-
medical Waste
treatment

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#
Category Type of Waste Type of Bag Treatment and Interpretation
or Disposal options
Container
to be Used

(1) (2) (3) (4) (5)

facility.
White Waste sharps including Puncture Autoclaving or Dry No Pre-
(Translucent) Metals: Needles, syringes proof, Leak Heat Sterilization treatment,
with fixed needles, needles proof, followed by shredding shredding/
from needle tip cutter or tamper proof or mutilation or mutilation
burner, scalpels, blades, or containers encapsulation in metal required to be
any other contaminated container or cement done by the
sharp object that may cause concrete; combination hospital if
puncture and cuts. This of shredding cum handing over to
includes both used, autoclaving; and sent the operator of
discarded and contaminated for final disposal to common Bio-
metal sharps iron foundries (having medical Waste
consent to operate from treatment
the State Pollution facility.
Control Boards or
Pollution Control
Committees) or
sanitary landfill or
designated concrete
waste sharp pit.

Blue (a) Glassware: Broken or Cardboard Disinfection (by No Pre-


discarded and boxes with soaking the washed treatment,
contaminated glass blue glass waste after required to be
including medicine vials coloured cleaning with detergent done by the
and ampoules except marking and Sodium hospital.
those contaminated with Hypochlorite
cytotoxic wastes. treatment) or through
autoclaving or
(b) Metallic Body Cardboard microwaving or
Implants boxes with hydroclaving and then
blue sent for recycling.
coloured
marking

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*Disposal by deep burial is permitted only in rural or remote areas where there is no access
to common biomedical waste treatment facility. This will be carried out with prior
approval from the prescribed authority and as per the Standards specified in Annexure 3.
The deep burial facility shall be located as per the provisions and guidelines issued by
Central Pollution Control Board from time to time.

Note:

1. BMW will not be mixed with other non-infectious wastes. If by mistake this has
occurred, this non-infectious waste will then be treated as BMW.
2. BMW shall be segregated into containers/bags at the point of generation. The containers
will be labelled with BIOHAZARD symbol which will be non-washable and prominently
visible.
3. All plastic bags shall be as per BIS standards as and when published, till then the
prevailing Plastic Waste Management Rules shall be applicable.
4. Chemical treatment using at least 10% Sodium Hypochlorite having 30% residual
chlorine for twenty minutes or any other equivalent chemical reagent that should
demonstrate Log104 reduction efficiency for microorganisms as given in Annexure 3.
#
Interpretation – Using 10% Sodium Hypochlorite is enough as it contains at least 30%
Residual Chlorine. Hospital is not required to measure 30% residual Chlorine if hospital is
using 10% Sodium Hypochlorite.

5. Mutilation or shredding must be to an extent to prevent unauthorized reuse.


Interpretation – Mutilation or shredding is to be done by the operator of common Bio-medical
#

Waste treatment facility.

6. There will be no chemical pre-treatment before incineration, except for microbiological,


lab and highly infectious waste.
#
Interpretation – Highly Infectious Waste shall mean the Biotechnology Waste. Pre-treatment
for microbiological, lab and highly infectious waste can be done by Autoclaving.

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7. Dead Foetus below the viability period (as per the Medical Termination of Pregnancy Act
1971, amended from time to time) can be considered as human anatomical waste. Such
waste should be handed over to the operator of common bio-medical waste treatment and
disposal facility in yellow bag with a copy of the official Medical Termination of
Pregnancy certificate from the Obstetrician or the Medical Superintendent of hospital or
healthcare establishment.
#
Interpretation – This shall not be applicable, if on MTP there is no solid foetus mass.

8. Cytotoxic drug vials shall not be handed over to unauthorised person under any
circumstances. These shall be sent back to the manufactures for necessary disposal at a
single point. As a second option, these may be sent for incineration at common bio-
medical waste treatment and disposal facility or TSDFs or plasma pyrolysis at
temperature >1200 0 C.

9. Residual or discarded chemical wastes, used or discarded disinfectants and chemical


sludge can be disposed at hazardous waste treatment, storage and disposal facility. In
such case, the waste should be sent to hazardous waste treatment, storage and disposal
facility through operator of common bio-medical waste treatment and disposal facility
only.
#
Interpretation – Residual or discarded chemical wastes or discarded disinfectants means any
un-used/expired/waste chemicals like acids or alkalis or disinfectants. Chemical sludge means
sludge removed from the Pre-treatment tank or the scaling removed from the pre-treatment
tank whenever it is cleaned.

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10. Syringes should be either mutilated or needles should be cut and or stored in tamper
proof, leak proof and puncture proof containers for sharps storage. Wherever the occupier
is not linked to a disposal facility it shall be the responsibility of the occupier to sterilize
and dispose in the manner prescribed.
#
Interpretation – No mutilation of syringes or cutting of needles required to be done by the
hospital, if handing over to the operator of common Bio-medical Waste treatment facility.

11. Spill management will be done as per hospital policy.

12. Adequate and proper personal protective equipment (PPE) i.e., boots, apron, gloves etc.
will be made available at user end wherever required, and worn at appropriate occasions.

13. Hand washing facilities will be made available at all appropriate locations.

14. BMW from patient care area & temporary storage site will be cleared regularly,
preferably in each shift depending on the amount of waste generated.

15. Untreated human anatomical waste, animal anatomical waste, soiled waste and,
biotechnology waste shall not be stored beyond a period of forty –eight hours:
Provided that in case for any reason it becomes necessary to store such waste
beyond such a period, the occupier shall take appropriate measures to ensure that the
waste does not adversely affect human health and the environment and inform the
prescribed authority along with the reasons for doing so.

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Biomedical Waste Management

BMW / SOP No. 03

________________________________________________________________

Title: Segregation of Waste

Objective: Segregation of Bio-medical waste as per guidelines.

Job Responsibility: Doctors, Nurses, Technicians, GDA, all employees handling BMW.

Description

1. No untreated bio-medical waste shall be mixed with other wastes.

2. The bio-medical waste shall be segregated as per categories applicable, into containers or
bags at the point of generation e.g., all patient care activity areas, diagnostic service areas,
operation theatre areas, treatment rooms etc. prior to its storage, transportation, treatment
and disposal.

3. Containers and bags are labelled with relevant bio-hazard symbol (Annexure 1)

4. Waste is segregated into colour coded bags as specified.

5. Bins used for holding the colour coded bags should be of the same colour. In case a bin of
the same colour is not available due to some reason, a neutral colour bin may be used
with a prominent sticker of the colour of the bag pasted on the lid and/or body. The size
of the sticker must be approximately of half the size of the lid of the bin.

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6. All bags, containers or bins directly used in the collection of bio-medical wastes are
labelled with appropriate Hazard Symbol (Annexure 1)

7. The labelling of the waste at the point of generation is in the form of a tag or adhesive
label which is to be attached to the bag or container when it is collected by the cleaning
staff (Annexure 2). This waste tagging system allows waste audits conducted at treatment
/ disposal points to identify areas that are in compliance.

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Biomedical Waste Management

BMW / SOP No. - 04

________________________________________________________________

Title: Waste Removal & Transportation

Objective: Waste removal & transportation to minimize the risk of any infection.

Job Responsibility: Housekeeping staff

Description:

1. The staff handling waste must use PPE.

2. The bags must be removed when ¾th full, if not earlier.

3. The waste bag is tied up & transferred to the temporary storage area on the same floor
(e.g. Dirty Utility) carefully, without any spillage. In the temporary storage area these
bags may be put in a larger bag of the same colour with an appropriate label. The label
must at least contain the following information
Date
Area / Floor / Unit
Shift

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4. The garbage is temporarily stored in the respective bag as per colour coding.

5. At shift end garbage from every floor is transported by designated trolley to central waste
collection area.

6. The waste movement is to be done through a designated lift. No other material / Patient
should be allowed with the Bio-Medical waste in the same lift

7. The housekeeping staff to ensure that all bags are tied when being transported & there is
no spillage or leakage.

8. In case any bags has a cut or tear, ensure that double bagging is done before moving it.

9. In case of spill, refer to Infection Control Policy of the hospital.

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Biomedical Waste Management

BMW / SOP No. 05

________________________________________________________________

Title: Treatment and Disposal

Objective: To Pre-Treat Chemical liquid waste, Microbiology waste & other Lab waste,
including Blood Bags

Job Responsibility: Lab Staff, Blood Bank Staff, Engineering, Housekeeping & Security

Description:

1. Bio-medical waste shall be pre-treated and disposed of in accordance with Table I, and in
compliance with the standards provided in Annexure 3, by the health care facilities

2. Occupier shall hand over segregated waste as per the Table I to common bio medical
waste treatment facility for treatment, processing and final disposal: Provided that the lab
and highly infectious bio-medical waste generated shall be pre-treated by equipment like
autoclave or microwave.

3. No occupier shall establish on-site treatment and disposal facility, if a service of common
bio-medical waste treatment facility is available at a distance of seventy-five kilometre.

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4. Any person including an occupier or operator of a common bio medical waste treatment
facility, intending to use new technologies for treatment of bio medical waste other than
those listed in Schedule I shall request the Central Government for laying down the
standards or operating parameters.

5. Every occupier shall phase out use of non-chlorinated plastic bags within two years from
the date of publication of Bio-Medical Waste Management Rules, 2016 (i. e. latest by
27th March 2018) and thereafter, the chlorinated plastic bags shall not be used for storing
and transporting of bio-medical waste and the bags used for storing and transporting
biomedical waste shall be in compliance with the Bureau of Indian Standards. Till the
Standards are published, the carry bags shall be as per the Plastic Waste Management
Rules, 2011.

6. After ensuring treatment by autoclaving or microwaving followed by mutilation or


shredding, whichever is applicable, the recyclables from the treated bio-medical wastes
such as plastics and glass shall be given to such recyclers having valid authorisation or
registration from the respective prescribed authority.
#
Interpretation – Mutilation or shredding is to be done by the operator of common Bio-medical
Waste treatment facility.

7. The Occupier or Operator of a common bio-medical waste treatment facility shall


maintain a record of recyclable wastes referred to in sub-rule (9) which are auctioned or
sold and the same shall be submitted to the prescribed authority as part of its annual
report. The record shall be open for inspection by the prescribed authorities.
#
Interpretation – Not applicable for Hospitals handing over ‘Contaminated Waste (Recyclable)’
to the operator of common Bio-medical Waste treatment facility.

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8. The handling and disposal of all the mercury waste and lead waste shall be in accordance
with the respective rules and regulations.

9. Microbiology waste and all other clinical laboratory waste shall be pre-treated by
sterilisation to Log 6 or disinfection to Log 4, as per the World Health Organisation
guidelines before packing and sending to the common bio-medical waste treatment
facility.
#
Interpretation – pre-treated by sterilization to Log 6 or disinfection to Log 4 can be achieved
by Autoclaving and validation for the same can be done through Routine Test (at least one
Class 1Chemical indicator/Process Indicator in each Cycle) & Spore Testing (Biological
Indicator once a week) described in the Standards of Autoclaving. The records for the same to
be maintained for 5 years.

10. Chemical treatment using at least 10% Sodium Hypochlorite having 30% residual
chlorine for twenty minutes or any other equivalent chemical reagent that should
demonstrate Log104 reduction efficiency for microorganisms as given in Annexure 3.
#
Interpretation – Using 10% Sodium Hypochlorite is enough as it contains at least 30%
Residual Chlorine. Hospital is not essential to measure 30% residual Chlorine if hospital is
using 10% Sodium Hypochlorite.

11. There will be no on site chemical pre-treatment except for Microbiology, Biotechnology
and other clinical laboratory waste listed under category (h) of the waste to be disposed in
Yellow category in Table 1, and highly infectious waste.

12. Residual or discarded chemical wastes, used or discarded disinfectants and chemical
sludge can be disposed at hazardous waste treatment, storage and disposal facility. In
such case, the waste should be sent to hazardous waste treatment, storage and disposal
facility through operator of common bio medical waste treatment and disposal facility
only.

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13. On-site pre-treatment of laboratory waste, microbiological waste, blood samples, blood
bags should be disinfected or sterilized as per the Guidelines of World Health
Organisation or National AIDS Control Organisation and then given to the common bio-
medical waste treatment and disposal facility.

14. Syringes should be either mutilated or needles should be cut and or stored in tamper
proof, leak proof and puncture proof containers for sharps storage. Wherever the occupier
is not linked to a disposal facility it shall be the responsibility of the occupier to sterilize
and dispose in the manner prescribed.
#
Interpretation – No mutilation of syringes or cutting of needles required to be done by the
hospital if handing over to the operator of common Bio-medical Waste treatment facility

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Biomedical Waste Management

BMW / SOP No. 06

________________________________________________________________

Title: Waste storage & Transportation to Waste Treatment Facility

Objective: Waste storage and transport to Waste treatment facility.

Job Responsibility: Housekeeping Staff / Security Supervisor / Housekeeping Supervisor /


Outsourced Agency

Frequency: Ideally daily, but definitely within 48 hrs for at least untreated human anatomical
waste, animal anatomical waste, soiled waste and biotechnology waste.

Description:

1. Bio-medical waste should not be mixed with other waste. There should be a clear
physical differentiation between the storage areas of general and Bio-medical waste

2. The Bio-medical waste should be stored in safe, ventilated and secured location for
storage of segregated biomedical waste in Coloured Bags or containers as per colour
coding norms. These containers and the bags should have the hazard symbols as per
Annexure 1.

3. Establish a Bar-Code System for bags or containers containing bio-medical waste to be


sent out of the premises or place for any purpose within one year from the date of the
notification of these rules. (i. e. latest by 27 th March 2017).

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4. At the time of collection of general waste and bio-medical waste from the Central
Garbage area by the contracted waste removal agency, Security Supervisor or
Housekeeping Supervisor must be present and ensure that there is no mixing of different
types of waste.

5. Weighing will be done at the central area and weight mentioned on a register maintained
for this purpose.

6. When the container/bags are to be transported from the premises where the Bio-medical
waste is generated to the authorized Waste Treatment Facility outside the premises, the
container/bag shall, apart from the label as per Annexure 1, also carry information
prescribed in Annexure 2. These Bags/Containers shall also carry Bar Code, once the
Bar-Coding system is established (latest by 27th March 2017).

7. Bio-medical Waste shall be transported only in such vehicle as may be authorized for the
purpose (Ref Housekeeping SOP on Garbage Removal & Transportation) This vehicle
would be supplied by the authorized, contracted Waste Disposal agency.

8. Untreated human anatomical waste, animal anatomical waste, soiled waste and,
biotechnology waste shall not be stored beyond a period of forty –eight hours:
Provided that in case for any reason it becomes necessary to store such waste
beyond such a period, the occupier shall take appropriate measures to ensure that the
waste does not adversely affect human health and the environment and inform the
prescribed authority along with the reasons for doing so.

9. Inform the prescribed authority immediately in case the operator of a facility does not
collect the bio-medical waste within the intended time or as per the agreed time.

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Biomedical Waste Management

BMW / SOP No. 07

________________________________________________________________

Title: Licensing & Other requirements for Bio-medical Waste Management

Objective: Licensing & Other requirements for Bio-medical Waste management

Job Responsibility: Head- Administration

Frequency: As per prescribed timelines

Description:

1. Application for Authorization


a. Every occupier handling bio-medical waste, irrespective of the quantity shall make
an application in Form II (Annexure 5) to the prescribed authority i.e. State Pollution
Control Board and Pollution Control Committee, as the case may be, for grant of
authorisation and the prescribed authority shall grant the provisional authorisation in
Form III (Annexure 6) and the validity of such authorisation for bedded health care
facility shall be synchronised with the validity of the consents .
b. Disposal of this application shall be done by the authority (Pollution Control Board
in states or Pollution Control Committee in union territories, as the case may be)

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within 90 days from the date of receipt, failing which it shall be deemed that the
authorisation is granted under the Biomedical Waste Management Rules.
c. In case of any change in the bio-medical waste generation, handling, treatment and
disposal for which authorisation was earlier granted, the occupier or operator shall
intimate to the prescribed authority about the change or variation in the activity and
shall submit a fresh application in Form II (Annexure 5) for modification of the
conditions of authorisation.
d. Occupier should apply for Renewal at least 3 months prior to expiry of the
Authorization.

2. Annual Report
a. Every occupier or operator of common bio-medical waste treatment facility shall
submit an Annual Report to the prescribed authority in Form-IV (Annexure 7) on or
before the 30th June of every year. The prescribed authority shall compile, review
and analyse the information received and send this information to the Central
Pollution Control Board on or before the 31st July of every year.
b. The Annual Reports shall also be made available online on the websites of Occupier
& all healthcare facilities shall make own website within two years from the date of
notification of Bio-Medical Waste Management Rules, 2016 (i.e. latest by 27th
March 2018).
c. The annual report shall also contain
i. Number of Beds (# Interpretation – Census or Registered Beds)
ii. Category wise quantity of waste generated or disposed in Kgs per annum (on
monthly average basis). (# Interpretation – Month wise and Total Annual Quantity)
iii. General Solid Waste (# Interpretation – Estimated Quantity is to be given)
iv. Details of the Storage, treatment, transportation, processing and Disposal
Facility

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#
Interpretation – Only Point No. (vi) is to be filled by the (Hospital) Occupier (if waste
is being handed over to the operator of common Bio-medical Waste treatment facility)
& rest of the points are for the operator of common Bio-medical Waste treatment
facility.
v. Minutes of Meeting of the Bio-Medical Waste Management Committee (Sub-
committee of Infection Control Committee) held during the reporting period.
vi. Records of all Trainings Conducted, including
 Number of Trainings Conducted on BMW Management
 Number of Personnel Trained
 Number of Personnel Trained at the time of induction
 Number of Personnel not undergone any training so far
 Whether any standard manual for training is available
vii. Report of all accidents (major and minor) and the remedial actions taken,
including Nil Report in Form 1 (Annexure 8) including
 Number of Accidents occurred during the year
 Number of persons affected
 Remedial Actions taken with details (if any)
 Details of any Fatality occurred
viii. Liquid Waste generated and treatment methods in place including
 Number of times in a year when the standards were not met
ix. Whether disinfection method or sterilization meeting the log 4 standards
including
 Number of times in a year when the standards were not met

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3. Accident Reporting

a. Report major accidents (accident occurring while handling of bio-medical waste


having potential to affect large masses of public and includes toppling of the truck
carrying bio-medical waste, accidental release of bio-medical waste in any water
body but exclude accidents like needle prick injuries, mercury spills) including
accidents caused by fire hazards, blasts during handling of bio-medical waste and the
remedial action taken and the records relevant thereto, (including nil report) in Form I
(Annexure 8) to the prescribed authority and also along with the annual report. In
case of any major accident at any institution or facility or any other site while
handling bio-medical waste, the authorised person shall intimate immediately to the
prescribed authority about such accident and forward a report within twenty-four
hours in writing regarding the remedial steps taken, in Form I (Annexure 8).

b. Information regarding all other accidents and remedial steps taken shall be provided
in the annual report (including Nil report).

4. Maintaining of Records

a. Every occupier shall maintain records related to generation, collection, reception,


storage, transportation, treatment, disposal or any form of handling of bio-medical
waste for a period of 5 years in accordance with the Biomedical Waste Management
Rules, 2016 and guidelines issued by the Central Government or the Central Pollution
Control Board or the prescribed authority as the case may be.
#
Interpretation – Hospitals to maintain records of generation and storage (can be done at
the central collection/storage area) and pre-treatment where applicable (either at the point
of Pre-Treatment or at a common place) of bio-medical waste, for a period of five years.

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b. Maintain all record for operation of incineration, hydro or autoclaving etc., for a
period of five years.
#
Interpretation – Log Book for Hydro or Autoclaving is to be maintained for 5 years.
Record of Validation done by Chemical indicator Class 1 in each Batch, Biological
Indicator every week to be preserved for 5 years. Validation test for Autoclave in 3
consecutive cycles before the beginning of use of a new Autoclave, and once every 3
months, to be preserved for 5 years. Graphic or Computer records of Autoclaves to be
maintained for 5 years.
c. The records which are maintained should specify the area wise quantity of BMW
being generated throughout the hospital (Annexure 4). Date wise waste generation
sheet should be maintained for major areas – at least OT and ICU. These need to be
further amalgamated into monthly and annual sheets for reporting purposes.

d. Maintain for five years all records pertaining to Bio-Medical Waste, including but not
limited to
i. BMW Register (with at least including all elements of Annexure 4)
ii. On-site Pre-treatment
iii. Validation testing
iv. Accidents with remedial actions taken
v. Trainings
vi. Committee Meetings
vii. Health Check Ups
viii. Vaccinations
ix. Reports of vendor site visits
x. Correspondence to Authorities
#
Interpretation – The actual records of the Health Check-up & Vaccination may or may
not be preserved, but a Log Book of the Health Check Ups and a Log Book for vaccination
conducted is to be preserved for 5 years.

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5. Other Requirements

a. Copy of valid licence/certificate issued by the appropriate authority (State Pollution


Control Board) should be available with the unit. Person holding custody of these
document must be designated by the unit (e.g. Housekeeping Supervisor, MS, Head-
Admin, or similar)

b. The State authorized biomedical waste treatment facility will be visited at least once
in 6 months (by 2 persons nominated by the unit) to ascertain that BMW disposal is
done as per Biomedical Waste Management Rules, 2016. A formal report of the visit
will be submitted to the MS and Infection Control Team.

c. A copy of the vendor’s authorization by state authority (including list of authorized


vehicles) should be available with the unit. Person holding custody of these document
must be designated by the unit (e.g. Housekeeping Supervisor, MS, Head-Admin, or
similar). The list of vehicles authorized to collect BMW should be prominently
displayed at the Central storage area & available at security gate.

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BMW / SOP No. 08

________________________________________________________________

Title: Minimum terms of Service Level Agreement with the Vendor

The service level Agreement with the Vendor must as a minimum state that the vendor shall:

(a) Take all necessary steps to ensure that the bio-medical waste collected from the hospital
is transported, handled, stored, treated and disposed of, without any adverse effect to the
human health and the environment, in accordance with these rules and guidelines issued
by the Central Government or, as the case may be, the central pollution control board
from time to time;
(b) Ensure timely collection of bio-medical waste from the hospital as prescribed under
Biomedical Waste Management Rules, 2016.
(c) Ensure collection of biomedical waste (preferably) on each day including on holidays
also, but at least once every 48 Hours;
(d) Establish bar coding and global positioning system for handling of bio- medical waste
within one year; (i.e. latest by 27 th March 2017)
(e) Assist the hospital in training conducted by them for bio-medical waste management;
(f) Allow the hospital, to inspect and see whether the treatment is carried out as per the rules
by the operator at his premises;
(g) Display details of authorisation, treatment, annual report etc. on vendor’s web-site;
(h) Supply non-chlorinated plastic coloured bags to the hospital on chargeable basis, if
required;
(i) Transport the bio-medical waste from the hospital premises to any off-site bio-medical
waste treatment facility only in the vehicles having label as provided in part ‘A’ of the

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Schedule IV (Annexure 1) along with necessary information as specified in part ‘B’ of


the Schedule IV (Annexure 2).
(j) The vehicles used for transportation of bio-medical waste shall comply with the
conditions if any stipulated by the State Pollution Control Board or Pollution Control
Committee in addition to the requirement contained in the Motor Vehicles Act, 1988 (59
of 1988), if any or the rules made there under for transportation of such infectious waste.
(k) Submit a copy of the vendor’s authorization by the State Authority & the list of
authorized vehicles. In case of any change in the authorization status, or change in
authorized vehicles, the vendor shall inform the hospital,

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Biomedical Waste Management

BMW / SOP No. 09

________________________________________________________________

Title: Biomedical Waste Audit

Objective: Biomedical Waste Audit

Job Responsibility: Medical Superintendent, Infection Control Nurse & Officer, members
nominated by HICC.

Frequency: Weekly audit for at least one high risk area, monthly audit for the entire hospital for
process compliance & six monthly audit for waste transport and treatment facility

Description:

1. The hospital will carry out weekly audit for assessing compliance to biomedical waste
segregation and handling using the BMW Audit tool in at least one high risk area
(ANNEXURE 9).

2. Although the weekly audit will be for a single area (e.g. OT or CSSD or Dialysis etc), the
audits should be planned in such a manner that all high risk areas of the hospital are
covered regularly.

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3. In addition, there will be a comprehensive Audit of the entire hospital preferably within
the first two weeks of every month.

4. Audit will be the responsibility of a team nominated by the Hospital Infection Control
Committee (e.g. ICN for wards, Microbiologist/MS for OT & ICU, AMS for CSSD, Cath
Lab, Head Admin for HK areas, Laundry & Linen room, etc.).

5. Additionally, an audit of the biomedical waste transport and treatment facility will be
carried out at least once in six months.

6. The checklist provided in Annexure 8 will be used for audits. Units can make minor
modifications or additions to the checklist (no deletions allowed) to meet statutory
regulations (since these vary from state to state).

7. The completed audit sheets are to be kept for a period of at least 5 years along with other
Bio-Medical waste records.

8. Audit findings are to be presented in the Infection Control Committee meetings and
documented in the minutes of the meeting.

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ANNEXURE: 1

LABEL FOR BIO-MEDICAL WASTE CONTAINERS/BAGS

Note: Label shall be non-washable and prominently visible.

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ANNEXURE: 2

LABEL FOR TRANSPORT OF BIO-MEDICAL WASTE CONTAINERS/BAGS

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ANNEXURE: 3

STANDARDS FOR TREATMENT & DISPOSAL OF BIO-MEDICAL WASTES

1. STANDARD FOR INCINERATION:-


All incinerators shall meet the following operating and emission standards-

A. Operating Standards
(1) Combustion efficiency (CE) shall be at least 99.00%.
(2) The Combustion efficiency is computed as follows:
%CO2
CE = --------------------- X 100
%CO2 + % CO

(3) The temperature of the primary chamber shall be a minimum of 800 0 C


and the secondary chamber shall be minimum of 1050 0 C + 50 0 C.

B. Emission Standards

S. No. Parameter Standards


(1) (2) (3) (4)
Limiting Sampling Duration in
concentration in minutes, unless stated
mg Nm3 unless
stated
1. Particulate matter 50 30 or 1NM3 of sample volume,
whichever is more
2. Nitrogen Oxides 400 30 for online sampling or grab
NO and NO 2 sample
expressed as NO2
3. HCl 50 30 or 1NM3 of sample volume,
whichever is more
4. Total Dioxins and 0.1ng TEQ/Nm3 8 hours or 5NM3 of sample
Furans (at 11% O2) volume, whichever is more

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5. Hg and its 0.05 2 hours or 1NM3 of sample


compounds volume, whichever is more

C. Stack Height
Minimum stack height shall be 30 meters above the ground and shall be attached
with the necessary monitoring facilities as per requirement of monitoring of
‘general parameters’ as notified under the Environment (Protection) Act, 1986
and in accordance with the Central Pollution Control Board Guidelines of
Emission Regulation Part-III.
Note:
(a) The existing incinerators shall comply with the above within a period of two
years from the date of the notification.

(b) The existing incinerators shall comply with the standards for Dioxins and
Furans of 0.1ngTEQ/Nm3 , as given below within two years from the date of
commencement of these rules.

(c) All upcoming common bio-medical waste treatment facilities having


incineration facility or captive incinerator shall comply with standards for
Dioxins and Furans.

(d) The existing secondary combustion chambers of the incinerator and the
pollution control devices shall be suitably retrofitted, if necessary, to achieve
the emission limits.

(e) Wastes to be incinerated shall not be chemically treated with any chlorinated
disinfectants.

(f) Ash from incineration of biomedical waste shall be disposed of at common


hazardous waste treatment and disposal facility. However, it may be disposed

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of in municipal landfill, if the toxic metals in incineration ash are within the
regulatory quantities as defined under the Hazardous Waste (Management and
Handling and Transboundary Movement) Rules, 2008 as amended from time
to time.

(g) Only low Sulphur fuel like Light Diesel Oil or Low Sulphur Heavy Stock or
Diesel, Compressed Natural Gas, Liquefied Natural Gas or Liquefied
Petroleum Gas shall be used as fuel in the incinerator.

(h) The occupier or operator of a common bio-medical waste treatment facility


shall monitor the stack gaseous emissions (under optimum capacity of the
incinerator) once in three months through a laboratory approved under the
Environment (Protection) Act, 1986 and record of such analysis results shall
be maintained and submitted to the prescribed authority. In case of dioxins
and furans, monitoring should be done once in a year.

(i) The occupier or operator of the common bio-medical waste treatment facility
shall install continuous emission monitoring system for the parameters as
stipulated by State Pollution Control Board or Pollution Control Committees
in authorisation and transmit the data real time to the servers at State Pollution
Control Board or Pollution Control Committees and Central Pollution Control
Board.

(j) All monitored values shall be corrected to 11% Oxygen on dry basis.

(k) Incinerators (combustion chambers) shall be operated with such temperature,


retention time and turbulence, as to achieve Total Organic Carbon content in
the slag and bottom ashes less than 3% or their loss on ignition shall be less
than 5% of the dry weight.

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(l) The occupier or operator of a common bio-medical waste incinerator shall use
combustion gas analyser to measure CO 2 , CO and O 2 .

2. Operating and Emission Standards for Disposal by Plasma Pyrolysis or


Gasification:
A. Operating Standards:
All the operators of the Plasma Pyrolysis or Gasification shall meet the following
operating and emission standards:
(1) Combustion Efficiency (CE) shall be at least 99.99%.
(2) The Combustion Efficiency is computed as follows:
%CO2
CE = --------------------- X 100
%CO2 + % CO
(3) The temperature of the combustion chamber after plasma gasification shall
be 1050 ± 50o C with gas residence time of at least 2 (two) second, with
minimum 3 % Oxygen in the stack gas.
(4) The Stack height should be minimum of 30 m above ground level and
shall be attached with the necessary monitoring facilities as per
requirement of monitoring of ‘general parameters’ as notified under the
Environment (Protection) Act, 1986 and in accordance with the CPCB
Guidelines of Emission Regulation Part-III.
B. Air Emission Standards and Air Pollution Control Measures
(i) Emission standards for incinerator, notified at Sl No.1 above in this
Schedule, and revised from time to time, shall be applicable for the Plasma
Pyrolysis or Gasification also.
(ii) Suitably designed air pollution control devices shall be installed or
retrofitted with the ‘Plasma Pyrolysis or Gasification to achieve the above
emission limits, if necessary.

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(iii) Wastes to be treated using Plasma Pyrolysis or Gasification shall not be


chemically treated with any chlorinated disinfectants and chlorinated
plastics shall not be treated in the system.

C. Disposal of Ash Vitrified Material


The ash or vitrified material generated from the ‘Plasma Pyrolysis or Gasification
shall be disposed-off in accordance with the Hazardous Waste (Management,
Handling and Transboundary Movement) Rules 2008 and revisions made
thereafter in case the constituents exceed the limits prescribed under Schedule II
of the said Rules or else in accordance with the provisions of the Environment
(Protection) Act, 1986, whichever is applicable.

3. STANDARDS FOR AUTOCLAVING OF BIO-MEDICAL WASTE


The autoclave should be dedicated for the purposes of disinfecting and treating bio-
medical waste.
(1) When operating a gravity flow autoclave, medical waste shall be subjected to:
(i) a temperature of not less than 121° C and pressure of 15 pounds per square
inch (psi) for an autoclave residence time of not less than 60 minutes; or
(ii) a temperature of not less than 135° C and a pressure of 31 psi for an
autoclave residence time of not less than 45 minutes; or
(iii) a temperature of not less than 149° C and a pressure of 52 psi for an
autoclave residence time of not less than 30 minutes.
(2) When operating a vacuum autoclave, medical waste shall be subjected to a
minimum of three pre-vacuum pulse to purge the autoclave of all air. The air
removed during the pre-vacuum, cycle should be decontaminated by means of
HEPA and activated carbon filtration, steam treatment, or any other method to
prevent release of pathogen. The waste shall be subjected to the following:

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(i) a temperature of not less than 121°C and pressure of 15 psi per an
autoclave residence time of not less than 45 minutes; or
(ii) a temperature of not less than 135°C and a pressure of 31 psi for an
autoclave residence time of not less than 30 minutes;
(3) Medical waste shall not be considered as properly treated unless the time,
temperature and pressure indicators indicate that the required time, temperature
and pressure were reached during the autoclave process. If for any reasons, time
temperature or pressure indicator indicates that the required temperature, pressure
or residence time was not reached, the entire load of medical waste must be
autoclaved again until the proper temperature, pressure and residence time were
achieved.
(4) Recording of operational parameters: Each autoclave shall have graphic or
computer recording devices which will automatically and continuously monitor
and record dates, time of day, load identification number and operating parameters
throughout the entire length of the autoclave cycle.
(5) Validation test for autoclave: The validation test shall use four biological
indicator strips, one shall be used as a control and left at room temperature, and
three shall be placed in the approximate centre of three containers with the waste.
Personal protective equipment (gloves, face mask and coveralls) shall be used
when opening containers for the purpose of placing the biological indicators. At
least one of the containers with a biological indicator should be placed in the most
difficult location for steam to penetrate, generally the bottom centre of the waste
pile. The occupier or operator shall conduct this test three consecutive times to
define the minimum operating conditions. The temperature, pressure and
residence time at which all biological indicator vials or strips for three consecutive
tests show complete inactivation of the spores shall define the minimum operating
conditions for the autoclave. After determining the minimum temperature,

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pressure and residence time, the occupier or operator of a common biomedical


waste treatment facility shall conduct this test once in three months and records in
this regard shall be maintained.
(6) Routine Test: A chemical indicator strip or tape that changes colour when a
certain temperature is reached can be used to verify that a specific temperature has
been achieved. It may be necessary to use more than one strip over the waste
package at different locations to ensure that the inner content of the package has
been adequately autoclaved. The occupier or operator of a common bio medical
waste treatment facility shall conduct this test during autoclaving of each batch
and records in this regard shall be maintained.
(7) Spore testing: The autoclave should completely and consistently kill the
approved biological indicator at the maximum design capacity of each autoclave
unit. Biological indicator for autoclave shall be Geobacillusstearothermophilus
spores using vials or spore Strips; with at least 1X10 6 spores. Under no
circumstances will an autoclave have minimum operating parameters less than a
residence time of 30 minutes, a temperature less than 121o C or a pressure less than
15 psi. The occupier or operator of a common bio medical waste treatment and
disposal facility shall conduct this test at least once in every week and records in
this regard shall be maintained.

4. STANDARDS OF MICROWAVING:
(1) Microwave treatment shall not be used for cytotoxic, hazardous or radioactive
wastes, contaminated animal carcasses, body parts and large metal items.
(2) The microwave system shall comply with the efficacy test or routine tests and a
performance guarantee may be provided by the supplier before operation of the
limit.

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(3) The microwave should completely and consistently kill the bacteria and other
pathogenic organisms that are ensured by approved biological indicator at the
maximum design capacity of each microwave unit. Biological indicators for
microwave shall be Bacillus atrophaeusspores using vials or spore strips with at
least 1 x 104sporesper detachable strip. The biological indicator shall be placed
with waste and exposed to same conditions as the waste during a normal
treatment cycle.

5. STANDARDS FOR DEEP BURIAL


(1) A pit or trench should be dug about two meters deep. It should be half filled with
waste, then covered with lime within 50 cm of the surface, before filling the rest
of the pit with soil.
(2) It must be ensured that animals do not have any access to burial sites. Covers of
galvanised iron or wire meshes may be used.
(3) On each occasion, when wastes are added to the pit, a layer of 10 cm of soil shall
be added to cover the wastes.
(4) Burial must be performed under close and dedicated supervision.
(5) The deep burial site should be relatively impermeable and no shallow well should
be close to the site.
(6) The pits should be distant from habitation, and located so as to ensure that no
contamination occurs to surface water or ground water. The area should not be
prone to flooding or erosion.
(7) The location of the deep burial site shall be authorised by the prescribed authority.
(8) The institution shall maintain a record of all pits used for deep burial.
(9) The ground water table level should be a minimum of six meters below the lower
level of deep burial pit.

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6. STANDARDS FOR EFFICACY OF CHEMICAL DISINFECTION


Microbial inactivation efficacy is equated to “Log10 kill” which is defined as the
difference between the logarithms of number of test microorganisms before and after
chemical treatment. Chemical disinfection methods shall demonstrate a 4 Log10
reduction or greater for Bacillus Subtilis (ATCC 19659) in chemical treatment systems.

7. STANDARDS FOR DRY HEAT STERILIZATION


Waste sharps can be treated by dry heat sterilization at a temperature not less than 185 o C,
at least for a residence period of 150 minutes in each cycle, which sterilization period of
90 minutes. There should be automatic recording system to monitor operating
parameters.
(i) Validation test for Sharps sterilization unit
Waste sharps sterilization unit should completely and consistently kill the
biological indicator Geobacillus Stearothermophillus or Bacillus
Atropheausspoers using vials with at least log10 6 spores per ml. The test shall be
carried out once in three months.
(ii) Routine test
A chemical indicator strip or tape that changes colour when a certain temperature
is reached can be used to verify that a specific temperature has been achieved. It
may be necessary to use more than one strip over the waste to ensure that the
inner content of the sharps has been adequately disinfected. This test shall be
performed once in week and records in this regard shall be maintained.

8. STANDARDS FOR LIQUID WASTE


(1) The effluent generated or treated from the premises of occupier or operator of a
common bio medical waste treatment and disposal facility, before discharge into
the sewer should conform to the following limits-

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Parameters Permissible Limit


pH 6.5-9.0
Suspended solids 100 mg/l
Oil and grease 10 mg/l
BOD 30 mg/l
COD 250 mg/l
Bio-assay test 90% survival of fish after 96 hours in 100% effluent.

(2) Sludge from Effluent Treatment Plant shall be given to common bio-medical
waste treatment facility for incineration or to hazardous waste treatment, storage
and disposal facility for disposal.
#
Interpretation – Sludge from Effluent Treatment Plant means sludge removed from
the Pre-treatment tank or the scaling removed from the pre-treatment tank whenever it
is cleaned.

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ANNEXURE: 4

BIO MEDICAL WASTE RECORD (Sample only. Areas to be defined by respective facility).

BIOMEDICAL WASTE REGISTER TO BE RETAINED FOR 5 YEARS


DATE: SUPERVISOR NAME:
SHARP
CONTAINER
AREA wise YELLOW WHITE
YELLOW
Quantity RED CYTOTOXIC BLUE TRANSLUCENT

4th floor

3rd floor

O.T. Area

2nd floor

1st floor

Ground floor

Basement
TOTAL

SUPERVISOR
SIGN: Exe. Sign

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ANNEXURE: 5

FORM – II. APPLICATION FOR AUTHORISATION OR RENEWAL OF AUTHORISATION

(To be submitted by occupier of health care facility or common bio-medical waste treatment facility)

To,
The Prescribed Authority
(Name of the State or UT Administration)
Address.

1. Particulars of Applicant:

(i) Name of the Applicant:

(In block letters & in full)

(ii) Name of the health care facility (HCF) or common bio-medical waste treatment
facility (CBWTF) :

(iii) Address for correspondence:

(iv) Tele No., Fax No.:

(v) Email:

(vi) Website Address:

2. Activity for which authorisation is sought:


Activity Please tick
Generation, segregation
Collection,
Storage
packaging
Reception
Transportation

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Activity Please tick


Treatment or processing or conversion
Recycling
Disposal or destruction
use
offering for sale, transfer
Any other form of handling

3. Application for  fresh or  renewal of authorisation (please tick whatever is applicable):


(i) Applied for CTO/CTE Yes/No
(ii) In case of renewal previous authorisation number and date:
------------------------------------------------------
(iii) Status of Consents:
i. under the Water (Prevention and Control of Pollution) Act, 1974
------------------------------------------------------
ii. under the Air (Prevention and Control of Pollution) Act, 1981:
------------------------------------------------------

4.
(i) Address of the health care facility (HCF) or common bio-medical waste treatment
facility (CBWTF):

(ii) GPS coordinates of health care facility (HCF) or common bio-medical waste
treatment facility (CBWTF):

5. Details of health care facility (HCF) or common bio-medical waste treatment facility
(CBWTF):
(i) Number of beds of HCF: (# Interpretation – Census or Registered Beds)
(ii) Number of patients treated per month by HCF:
(iii) Number healthcare facilities covered by CBMWTF: ______
(iv) No. of beds covered by CBMWTF: ______
(v) Installed treatment and disposal capacity of CBMWTF:_______ Kg per day
(vi) Quantity of biomedical waste treated or disposed by CBMWTF:_____ Kg/ day

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(vii) Area or distance covered by CBMWTF:______________


(pl. attach map a map with GPS locations of CBMWTF and area of coverage)
(viii) Quantity of Biomedical waste handled, treated or disposed:
Category Type of Waste Quantity Method of Treatment
Generated or and Disposal (Refer
Collected, kg/day Schedule-I)
(1) (2) (3) (4)
Yellow (i) Human Anatomical Waste:
(ii) Animal Anatomical Waste:
(iii) Soiled Waste:
(iv) Expired or Discarded
Medicines:
(v) Chemical Solid Waste:
(vi) Chemical Liquid Waste :
(vii) Discarded linen,
mattresses, beddings
contaminated with blood or
body fluid.
(viii) Microbiology,
Biotechnology and other
clinical laboratory waste:
Red Contaminated Waste
(Recyclable)
White Waste sharps including Metals:
(Translucent)
Blue Glassware:
Metallic Body Implants

6. Brief description of arrangements for handling of biomedical waste (attach details):


(i) Mode of transportation (if any) of bio-medical waste:

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(ii) Details of treatment equipment (please give details such as the number, type &
capacity of each unit)

No. of units Capacity of each unit


Incinerators :
Plasma Pyrolysis:
Autoclaves:
Microwave:
Hydroclave:
Shredder:
Needle tip cutter or destroyer
Sharps encapsulation or
concrete pit:
Deep burial pits:
Chemical disinfection:
Any other treatment equipment:

7. Contingency plan of common bio-medical waste treatment facility (CBWTF)(attach


documents):

8. Details of directions or notices or legal actions if any during the period of earlier
authorisation.

9. Declaration
I do hereby declare that the statements made and information given above are true to the best
of my knowledge and belief and that I have not concealed any information.
I do also hereby undertake to provide any further information sought by the prescribed
authority in relation to these rules and to fulfil any conditions stipulated by the prescribed
authority.
Date: Sign of the Applicant
Place: Designation of the Applicant

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ANNEXURE 6

FORM –III. AUTHORISATION

(Authorisation for operating a facility for generation, collection, reception, treatment, storage,
transport and disposal of biomedical wastes)

1. File number of authorisation and date of issue……………………………………….


2. M/s __________________ an occupier or operator of the facility located at
______________________ is hereby granted an authorisation for;

Activity Please tick


Generation, segregation
Collection,
Storage
packaging
Reception
Transportation
Treatment or processing or conversion
Recycling
Disposal or destruction
use
offering for sale, transfer
Any other form of handling

3. M/s _____________________________ is hereby authorized for handling of biomedical


waste as per the capacity given below;
(i) Number of beds of HCF:
(ii) Number healthcare facilities covered by CBMWTF: ______
(iii)Installed treatment and disposal capacity:_______ Kg per day
(iv) Area or distance covered by CBMWTF:______________
(v) Quantity of Biomedical waste handled, treated or disposed:

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Type of Waste Category Quantity permitted for Handling


Yellow
Red
White (Translucent)
Blue

4. This authorisation shall be in force for a period of …………. Years from the date of
issue.
5. This authorisation is subject to the conditions stated below and to such other conditions
as may be specified in the rules for the time being in force under the Environment
(Protection) Act, 1986.
Date: …………………… Sign ………………………
Place …………………… Designation: ……………..
Terms and conditions of authorisation *

1. The authorisation shall comply with the provisions of the Environment (Protection) Act,
1986 and the rules made there under.
2. The authorisation or its renewal shall be produced for inspection at the request of an
officer authorised by the prescribed authority.
3. The person authorized shall not rent, lend, sell, transfer or otherwise transport the
biomedical wastes without obtaining prior permission of the prescribed authority.
4. Any unauthorised change in personnel, equipment or working conditions as mentioned in
the application by the person authorised shall constitute a breach of his authorisation.
5. It is the duty of the authorised person to take prior permission of the prescribed authority
to close down the facility and such other terms and conditions may be stipulated by the
prescribed authority.

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ANNEXURE: 7

FORM IV

ANNUAL REPORT

[To be submitted to the prescribed authority on or before 30th June every year for the period
from January to December of the preceding year, by the occupier of health care facility (HCF) or
common bio-medical waste treatment facility (CBWTF)]

S.No. Particulars
1. Particulars of the Occupier :
(i) Name of the authorised person :
(occupier or operator of
facility)
(ii) Name of HCF or CBMWTF :
(iii) Address for Correspondence :
(iv) Address of Facility :
(v) Tel. No, Fax. No :
(vi) E-mail ID :
(vii) URL of Website :
(viii) GPS coordinates of HCF or :
CBMWTF
(ix) Ownership of HCF or : (State Government or Private or Semi Govt.
CBMWTF or any other)
(x) Status of Authorisation under : Authorisation No.:
the Bio-Medical Waste ………………………………………………
(Management and Handling) ……valid up to ………
Rules
(xi) Status of Consents under : Valid up to:
Water Act and Air Act

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S.No. Particulars
2. Type of Health Care Facility :
(i) Bedded Hospital : No. of beds (# Interpretation – Census or Registered Beds)
(ii) Non-bedded hospital (Clinic or :
Blood Bank or Clinical
Laboratory or Research Institute
or Veterinary Hospital or any
other)
(iii) License number and its date of :
expiry
3. Details of CBMWTF :
(i) Number healthcare facilities :
covered by CBMWTF
(ii) No. of beds covered by :
CBMWTF
(iii) Installed treatment and : _______ Kg per day
disposal capacity of
CBMWTF:
(iv) Quantity of biomedical waste : _____ Kg/day
treated or disposed by
CBMWTF
4. Quantity of waste generated or : Yellow Category:
disposed in Kg per annum (on
Red Category:
monthly average basis)
White:
(# Interpretation – Month wise and Total
Annual Quantity) Blue Category :
General Solid waste:
5. Details of the Storage, treatment, transportation, processing and Disposal Facility
#
Interpretation – Only Point No. (vi) is to be filled by the (Hospital) Occupier (if waste is being
handed over to the operator of common Bio-medical Waste treatment facility) & rest of the
points are for the operator of common Bio-medical Waste treatment facility.

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S.No. Particulars
(i) Details of the on-site storage Size:
facility
Capacity:
Provision of on-site storage : (cold storage or
any other provision)
(ii) Disposal facilities Type of trea tment No. of Ca pa c Qua ntity
equipment uni ts i ty trea ted or
Kg/da di s posed i n
y kg per
a nnum
Inci nerators
Pl a sma Pyrolysis
Autocl aves
Mi crowa ve
Hydrocl ave
Shredder
Needle tip cutter
or des troyer
Sha rps
enca psulation or
concrete pit
Deep burial pits:
Chemi cal
di s infection:
Any other
trea tment
equipment:
(iii)Quantity of recyclable wastes Red Category (like plastic, glass etc.)
sold to authorized recyclers after
treatment in kg per annum.
(iv) No of vehicles used for collection
and transportation of biomedical
waste
(v) Details of incineration ash and Quantity Where
ETP sludge generated and generated disposed
Incineration
disposed during the treatment of
Ash
wastes in Kg per annum ETP Sludge

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S.No. Particulars
(vi) Name of the Common Bio-
Medical Waste Treatment
Facility Operator through
which wastes are disposed of
(vii) List of member HCF not
handed over bio-medical waste
6. Do you have bio-medical waste
management committee? If yes,
attach minutes of the meetings held
during the reporting period
7. Details trainings conducted on BMW
(i) Number of trainings
conducted on BMW
Management.
(ii) number of personnel trained
(iii) number of personnel trained
at the time of induction
(iv) number of personnel not
undergone any training so far
(v) whether standard manual for
training is available?
(vi) any other information)
8. Details of the accident occurred
during the year
(i) Number of Accidents
occurred
(ii) Number of the persons
affected
(iii) Remedial Action taken
(Please attach details if any)

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S.No. Particulars
(iv) Any Fatality occurred, details
9. Are you meeting the standards of air
Pollution from the incinerator? How
many times in last year could not met
the standards?
Details of Continuous online
emission monitoring systems
installed
10. Liquid waste generated and treatment
methods in place. How many times
you have not met the standards in a
year?
11. Is the disinfection method or
sterilization meeting the log 4
standards? How many times you have
not met the standards in a year?
12. Any other relevant information (Air Pollution Control Devices attached with
the Incinerator)

Certified that the above report is for the period from ……………………………………………
………………………………………………………………………………………………………

Date: Name and Signature of the Head of the Institution

Place:

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ANNEXURE: 8

FORM I

ACCIDENT REPORTING

1. Date and time of accident:


2. Type of Accident:
3. Sequence of events leading to accident:
4. Has the Authority been informed immediately:
5. The type of waste involved in accident:
6. Assessment of the effects of the accidents on human health and the environment:
7. Emergency measures taken:
8. Steps taken to alleviate the effects of accidents:
9. Steps taken to prevent the recurrence of such an accident:
10. Does you facility has an Emergency Control policy? If yes give details:

Date....................... Signature..............................

Place...................... Designation.................................

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ANNEXURE: 9

BIOMEDICAL WASTE AUDIT SHEET

PART A: Bio Medical Waste Segregation & Disposal Audit

 Weekly audit to be done for at least one high risk area (OT, CSSD, ICU, Dialysis, Lab,
Cath Lab & Procedure rooms, Labour Room, ER, Chemo/Day Care, Central BMW
storage room)

 Although the weekly audit will be for a single high risk area, the audits shall be planned
in such a manner that all high risk areas of the hospital are covered regularly.
 In addition to the weekly audits, a monthly audit covering the entire hospital to be carried
out preferably within first two weeks of each month.

 Audit to be conducted by team nominated by the Hospital Infection Control Committee


(e.g. ICN for wards, Microbiologist/MS for OT & ICU, AMS for CSSD, Cath Lab, Head
Admin for HK areas, Laundry & Linen room, etc.)

 After completion of audit, audit report to be submitted to Infection Control Officer with
copy to MS. Sheets must be retained for 5 years

 BMW Audit reports discussion to be a fixed agenda in HICC meetings

S. Audit Criteria for Weekly/Monthly Audit Yes/No Comments


No.
1. Waste segregation information is prominently
displayed near or on the waste bins

2. Staff (due for training) have attended a training


session on correct & safe disposal of clinical waste

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S. Audit Criteria for Weekly/Monthly Audit Yes/No Comments


No.
3. Staff are aware of the waste segregation procedures.
Interview 5 Staff

4 Staff are aware of the appropriate action to be taken


in case of spill/exposure

5 Is the waste segregated correctly?

6 Sharp disposal is done in sharps containers

7 Sharps containers are free from protruding sharps


from the inlet

8 All sharp bins are labeled with date and time of


starting of usage

9 Sharp bins are not filled more than 3/4th level

10 Inappropriate re-sheathing of needles does not occur


(Observation/interview)

11 Needles and syringes are discarded appropriately (as


specified/okayed by the state PCB)

12 The waste storage area is clean & dry

13 There is no storage of waste in corridors or in other


inappropriate areas inside/outside the facilities where
waste is awaiting collection

14 All plastic bags are well fitted within the bin

15 All waste bins are lidded & in good working order

16 All waste bins are visibly clean, externally &


internally

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S. Audit Criteria for Weekly/Monthly Audit Yes/No Comments


No.
17 Waste bags are removed from clinical areas daily

18 There is no emptying of clinical waste from one bag


to another

19 Waste bags are not more than 3 /4 th full

20 Bags carrying waste are sealed/tied securely during


transportation

21 Bags are labelled with information regarding point of


generation

22 Bags carrying soiled linen is labelled as ‘Bio-hazard’

23 Staff wear industrial gloves during transport of waste

24 A separate closed trolley is used for waste


transportation

25 The utility lift is used by the staff during waste


transportation (if available)

26 Is the dedicated area (Central Storage Area) for the


safe storage of biomedical waste (inside compound)
locked & inaccessible to animals & public

27 Is the dedicated area (Central Storage Area) a safe,


ventilated and secured location for storage of
segregated biomedical waste in coloured bags or
containers in the manner as specified in Schedule I, to
ensure that there shall be no secondary handling,
pilferage of recyclables or inadvertent scattering or
spillage by animals.
28 Is the bio-medical waste from such place or premises
directly transported in the manner as prescribed in

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S. Audit Criteria for Weekly/Monthly Audit Yes/No Comments


No.
these rules to the common bio-medical waste
treatment facility or for the appropriate treatment and
disposal, as the case may be, in the manner as
prescribed in Schedule I

29 The waste compound is kept clean & tidy and pest


free

30 Has the Pre-treatment of Microbiology,


Biotechnology and other clinical laboratory waste
been done on-site

The below mentioned points are to be only audited during the monthly audit covering the entire hospital

31 Is the BMW Register maintained & updated on a day


to day basis

32 Has the BMW been collected by the Vendor on each


day (as agreed in the terms & conditions with the
vendor) including holidays

33 In case the vendor has not collected the BMW on a


given day (as agreed in the terms & conditions with
the vendor) including holidays, was the appropriate
authority informed of the same

34 Is the copy of the Copy of valid licence/certificate


issued by the appropriate authority (State Pollution
Control Board) should be available with designated
person in the unit

35 Is a copy of the vendor’s authorization by state


authority (including list of authorized vehicles)
available with the designated person in the unit.

36 Is the list of vehicles authorized to collect BMW

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FORTIS HEALTHCARE LIMITED P age 7 3
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Standard Operating Procedure for

Bio Medical Waste Management

S. Audit Criteria for Weekly/Monthly Audit Yes/No Comments


No.
prominently displayed at the Central storage area &
available at security gate

37 Has the State authorized biomedical waste treatment


facility visited at least once in last 6 months (by 2
persons nominated by the unit) to ascertain that BMW
disposal is done as per Biomedical Waste
Management Rules, 2016 and a formal report of the
visit submitted to the MS and Infection Control Team

38 Has the monthly record of BMW generated in terms


of category & colour coding as specified in Table 1
displayed on the Website

39 Has the Chemical Liquid Waste been pre-treated in


the on-site Effluent/Sewage treatment Plant before
discharge

40 Has BMW management been discussed in the


Infection Control Committee Meeting and minutes
recorded (if the meeting was scheduled to be held in
the previous month as per the prescribed frequency)

41 Has Induction training on BMW been provided to all


new joinees (Health care workers) who joined during
the previous month

42 Has yearly training on BMW been provided to all


Health care Workers due for the same during the
previous month

43 Has Health Check-up been done for all new joinees


(Health care workers) who joined during the previous
month

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Standard Operating Procedure for

Bio Medical Waste Management

S. Audit Criteria for Weekly/Monthly Audit Yes/No Comments


No.
44 Has Immunization been done for all Health care
Workers due for the same during the previous month

45 In case of a major accident has the same been


reported along with the remedial actions within 24 hrs
to the appropriate authority

46 If applicable within the last month has the Annual


Report been submitted

47 If applicable within the last month has the application


for renewal of License been submitted

48 In case of any change in the bio-medical waste


generation, handling, treatment and disposal for
which authorisation was earlier granted, has the
intimation been sent to the prescribed authority about
the change or variation in the activity and shall
submit a fresh application in Form II for modification
of the conditions of authorisation.

Auditor’s Name and Signature:

Ward/Area audited:

Date:

Infection Control Officer Med Supdt.


MSOG/BMW-SACL/20160701/1.0

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Standard Operating Procedure for

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PART B: AUDIT SHEET FOR WASTE TRANSPORT AND TREATMENT

 Audit to be done at least once in six months

Audit Criteria YES NO

BMW is transported to a pollution control board approved


common waste treatment facility

Waste is transported in a closed vehicle which conforms to the


Pollution control board specifications & bears the name of the
treatment agency

Proper documentation of the waste records is maintained

Category Type of Waste Type of Bag Treatment and Yes/No


or Container Disposal options
to be Used

(1) (2) (3) (4)

Yellow (a) Human Anatomical Yellow Incineration or


Waste: Human tissues, coloured non- Plasma Pyrolysis or
organs, body parts and chlorinated deep burial*
foetus below the viability plastic bags
period (as per the Medical
Termination of Pregnancy
Act 1971, amended from
time to time).

(b) Animal Anatomical


Waste : Experimental
animal carcasses, body
parts, organs, tissues,
including the waste
generated from animals
used in experiments or
testing in veterinary
hospitals or colleges or

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Standard Operating Procedure for

Bio Medical Waste Management

Category Type of Waste Type of Bag Treatment and Yes/No


or Container Disposal options
to be Used

(1) (2) (3) (4)

animal houses.

(c) Soiled Waste: Items Incineration or


contaminated with blood, Plasma Pyrolysis or
body fluids like dressings, deep burial*
plaster casts, cotton swabs
and bags containing In absence of above
residual or discarded facilities,
blood and blood autoclaving or
components. micro-waving/
hydroclaving
followed by
shredding or
mutilation or
combination of
sterilization and
shredding. Treated
waste to be sent for
energy recovery.

(d) Expired or Discarded Yellow Expired `cytotoxic


Medicines: coloured non- drugs and items
Pharmaceutical waste like chlorinated contaminated with
antibiotics, cytotoxic plastic bags cytotoxic drugs to be
drugs including all items or containers returned back to the
contaminated with manufacturer or
cytotoxic drugs along supplier for
with glass or plastic incineration at
ampoules, vials etc. temperature >1200
0C or to common
bio-medical waste
treatment facility or
hazardous waste
treatment, storage
and disposal facility
for incineration at
>12000C Or
Encapsulation or
Plasma Pyrolysis at

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Standard Operating Procedure for

Bio Medical Waste Management

Category Type of Waste Type of Bag Treatment and Yes/No


or Container Disposal options
to be Used

(1) (2) (3) (4)

>12000C.
All other discarded
medicines shall be
either sent back to
manufacturer or
disposed by
incineration.

(e) Chemical Waste: Yellow Disposed of by


Chemicals used in coloured incineration or
production of biological containers or Plasma Pyrolysis or
and used or discarded non- Encapsulation in
disinfectants chlorinated hazardous waste
plastic bags treatment, storage
and disposal facility.

(f) Chemical Liquid Waste: Separate After resource


Liquid waste generated collection recovery, the
due to use of chemicals in system chemical liquid
production of biological leading to waste shall be pre-
and used or discarded effluent treated before
disinfectants, Silver X-ray treatment mixing with other
film developing liquid, system wastewater. The
discarded Formalin, combined discharge
infected secretions, shall conform to the
aspirated body fluids, discharge norms
liquid from laboratories given in Schedule-
and floor washings, III.
cleaning, housekeeping
and disinfecting activities
etc.

(g) Discarded linen, Non- Non- chlorinated


mattresses, beddings chlorinated chemical disinfection
contaminated with blood yellow plastic followed by
or body fluid. bags or incineration or
suitable Plazma Pyrolysis or
packing

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Standard Operating Procedure for

Bio Medical Waste Management

Category Type of Waste Type of Bag Treatment and Yes/No


or Container Disposal options
to be Used

(1) (2) (3) (4)

material for energy recovery.


In absence of above
facilities, shredding
or mutilation or
combination of
sterilization and
shredding. Treated
waste to be sent for
energy recovery or
incineration or
Plasma Pyrolysis.

(h) Microbiology, Autoclave Pre-treat to sterilize


Biotechnology and other safe plastic with non-chlorinated
clinical laboratory bags or chemicals on-site as
waste: Blood bags, containers. per National AIDS
Laboratory cultures, Control Organisation
stocks or specimens of or World Health
microorganisms, live or Organisation
attenuated vaccines, guidelines thereafter
human and animal cell for Incineration.
cultures used in research,
industrial laboratories,
production of biological,
residual toxins, dishes and
devices used for cultures.

Red Contaminated Waste Red coloured Autoclaving or


(Recyclable) non- micro-waving/
chlorinated hydroclaving
Wastes generated from plastic bags followed by
disposable items such as or containers shredding or
tubing, bottles, intravenous mutilation or
tubes and sets, catheters, urine combination of
bags, syringes (without sterilization and
needles and fixed needle shredding. Treated
syringes) and vacutainers with waste to be sent to
their needles cut) and gloves.

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FORTIS HEALTHCARE LIMITED P age 7 9
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Standard Operating Procedure for

Bio Medical Waste Management

Category Type of Waste Type of Bag Treatment and Yes/No


or Container Disposal options
to be Used

(1) (2) (3) (4)

registered or
authorized recyclers
or for energy
recovery or plastics
to diesel or fuel oil
or for road making,
whichever is
possible.

Plastic waste should


not be sent to landfill
sites.
White Waste sharps including Puncture Autoclaving or Dry
(Translucent) Metals: Needles, syringes proof, Leak Heat Sterilization
with fixed needles, needles proof, tamper followed by
from needle tip cutter or proof shredding or
burner, scalpels, blades, or containers mutilation or
any other contaminated sharp encapsulation in
object that may cause metal container or
puncture and cuts. This cement concrete;
includes both used, discarded combination of
and contaminated metal shredding cum
sharps autoclaving; and sent
for final disposal to
iron foundries
(having consent to
operate from the
State Pollution
Control Boards or
Pollution Control
Committees) or
sanitary landfill or
designated concrete
waste sharp pit.

Blue (a) Glassware: Broken or Cardboard Disinfection (by


discarded and boxes with soaking the washed
contaminated glass blue coloured glass waste after
including medicine vials cleaning with

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For internal circulation only
FORTIS HEALTHCARE LIMITED P age 8 0
of 80
Standard Operating Procedure for

Bio Medical Waste Management

Category Type of Waste Type of Bag Treatment and Yes/No


or Container Disposal options
to be Used

(1) (2) (3) (4)

and ampoules except marking detergent and


those contaminated with Sodium
cytotoxic wastes. Hypochlorite
(b) Metallic Body Implants Cardboard treatment) or through
boxes with autoclaving or
blue coloured microwaving or
marking hydroclaving and
then sent for
recycling.

Observations:

Auditor’s Name and Signature:

Designation:

Date:

Infection Control Officer Med Supdt.


(In case of improper waste treatment &/or disposal by outsourced vendor, please send
relevant information to the State Pollution Control Board)
MSOG/BMWTT-ACL/20160701/1.0

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