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FORTIS HEALTHCARE LIMITED Page1 of 80 Standard Operating Procedure for Bio Medical Waste Management This document contains proprietary information of FORTIS HEALTHCARE LTD For internal circulation only STANDARD OPERATING PROCEDURE BIO MEDICAL WASTE MANAGEMENT SOP Number: BMW-P-2016-1.1 Version Number: 1.1 Effective Date: 1 st July 2016 Supersedes Version: BMW-P- 2016-1.0 Next Review Date: 31 st March 2017 Prepared By: Dr Ravneet Kaur, Dr Anita Arora, Dr Anita Sharma Reviewe d By: Dr Akash Sud Approved By: Dr Bishnu Panigrahi

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Page 1: STANDARD OPERATING PROCEDURE BIO MEDICAL WASTE MANAGEMENTcdn.fortishealthcare.com/...Bio-Medical-Waste-Management-SOP_2.pdf · FORTIS HEALTHCARE LIMITED P a ge 2 o f 80 Standard Operating

FORTIS HEALTHCARE LIMITED P a g e 1 o f

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Standard Operating Procedure for

Bio Medical Waste Management

This document contains proprietary information of FORTIS HEALTHCARE LTD

For internal circulation only

STANDARD OPERATING

PROCEDURE

BIO MEDICAL WASTE

MANAGEMENT

SOP Number:

BMW-P-2016-1.1

Version Number:

1.1 Effective Date:

1st July 2016

Supersedes Version:

BMW-P-

2016-1.0 Next Review

Date:

31st March

2017

Prepared By:

Dr Ravneet

Kaur,

Dr Anita

Arora,

Dr Anita

Sharma

Reviewed By:

Dr

Akash

Sud

Approved By:

Dr Bishnu Panigrahi

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FORTIS HEALTHCARE LIMITED P a g e 2 o f

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Standard Operating Procedure for

Bio Medical Waste Management

This document contains proprietary information of FORTIS HEALTHCARE LTD

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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

management

34

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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Standard Operating Procedure for

Bio Medical Waste Management

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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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Standard Operating Procedure for

Bio Medical Waste Management

This document contains proprietary information of FORTIS HEALTHCARE LTD

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I. Change Control Information

Version

Number:

1.1 Effective

Date:

1st July

2016

Supersedes

Version:

BMW-P-

2016-1.0

Next

Review Date:

Changes Made:

Reason for change:

Adding Interpretations received from CPCB Dt 08/06/2016

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Standard Operating Procedure for

Bio Medical Waste Management

This document contains proprietary information of FORTIS HEALTHCARE LTD

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II. Functional Organizational Structure (Organogram)

(TO BE DEVELOPED BY FACILITY)

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Standard Operating Procedure for

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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

provided by this department is...

Biomedical waste is generated in all patient care

areas and needs to be managed as per the

applicable statutory regulations

The methods used in order to customize

services are....

Biomedical waste segregation

Biomedical waste storage till transportation to

final treatment/disposal site

The extent to which the level of care/

services provided meets customer needs are:

Color coded waste disposal bags 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

service…

State Pollution Control Board

Staffing plan is...

Supervisor – 1

GDA/Housekeeping - as required

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Standard Operating Procedure for

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IV. Common Abbreviations

Sl.

No.

Abbreviation Full Form

1 Listed in each process

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Standard Operating Procedure for

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V. Definitions

Sl.

No.

Term Definition

1 Authorised Person

"authorised person" means an occupier or operator authorised by the 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 Waste

"bio-medical waste" means any waste, which is generated during the 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

Accident

Major Accident means 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.

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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Standard Operating Procedure for

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VI. Involved Personnel (Roles & Responsibilities)

Sl.

No.

Process Functional Responsibility Charge

1 Segregation of Waste at source

Doctors, Nurses, Technicians, GDAs (including all employees involved in

generation & segregation of BMW)

MS, CoN

2 Transport to temporary

Storage Area

Housekeeping Head – Admin

3 Transport to Central

Garbage Area

Housekeeping Head – Admin

4 Storage and Handover to Collecting Agency

Housekeeping, Security Head – Admin

5 Timely Submission of Reports to Authorities

Housekeeping/Administration Head – Admin

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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Standard Operating Procedure for

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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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Standard Operating Procedure for

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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

or

Container

to be Used

Treatment and

Disposal options

#Interpretation

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

Yellow (a) Human Anatomical Waste: Human tissues, organs, body parts and foetus below the viability period (as per the Medical Termination of

Yellow coloured non-chlorinated

plastic bags

Incineration or Plasma Pyrolysis or deep

burial*

No Pre-treatment required to be done in the hospital.

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Category Type of Waste Type of Bag

or Container

to be Used

Treatment and

Disposal options

#Interpretation

(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 contaminated with blood, body fluids like dressings, plaster casts, cotton swabs and bags containing residual or discarded blood and blood components.

Incineration or Plasma Pyrolysis or deep

burial*

In absence of above facilities, autoclaving or micro-waving/ hydroclaving followed by shredding or mutilation or combination of sterilization and shredding. Treated waste to be sent for

energy recovery.

No Pre-treatment required to be done in the hospital, except for Blood Bags which need to be Autoclaved.

(d) Expired or Discarded

Medicines: Pharmaceutical waste like antibiotics, cytotoxic drugs including all items contaminated with cytotoxic drugs along

Yellow coloured non-chlorinated plastic bags

or containers

Expired `cytotoxic drugs and items contaminated with cytotoxic drugs to be returned back to the manufacturer or supplier for incineration at

Cytotoxic drugs & items contaminated with cytotoxic drugs to be put in Yellow Bag with Cytotoxic Hazard Symbol.

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Category Type of Waste Type of Bag

or Container

to be Used

Treatment and

Disposal options

#Interpretation

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

with glass or plastic

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

>12000C.

All other discarded medicines shall be either sent back to manufacturer or disposed by

incineration.

Sharps contaminated with Cytotoxic Drugs to be put in a puncture Proof Box (Cardboard etc ) before putting in Yellow Bag. Cytotoxic & Pharmaceutical Waste can be handed over to the operator of common Bio-medical Waste treatment facility.

(e) Chemical Waste: Chemicals used in production of biological and used or discarded disinfectants

Yellow coloured containers or non-chlorinated

plastic bags

Disposed of by incineration or Plasma Pyrolysis or Encapsulation in hazardous waste treatment, storage and

disposal facility.

No Pre-treatment required to be done in the hospital.

(f) Chemical Liquid Waste: Liquid waste generated due to use of chemicals in production of biological and used or discarded disinfectants, Silver X-ray film developing liquid, discarded Formalin, infected

Separate collection system leading to effluent treatment

system

After resource recovery, the chemical liquid waste shall be pre-treated before mixing with other wastewater. The combined discharge shall conform to the discharge norms given

Separate collection system leading to effluent / sewage treatment system The combined discharge shall conform to the discharge norms

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Category Type of Waste Type of Bag

or Container

to be Used

Treatment and

Disposal options

#Interpretation

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

secretions, aspirated body fluids, liquid from laboratories and floor washings, cleaning, housekeeping and disinfecting activities

etc.

in Schedule- III. given in Schedule - II, to be ascertained by the Prescribed authorities.

(g) Discarded linen, mattresses, beddings contaminated with

blood or body fluid.

Non-chlorinated yellow plastic bags or suitable packing

material

Non- chlorinated chemical disinfection followed by incineration or Plazma Pyrolysis or 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.

No Pre-treatment, shredding/ mutilation required to be done in the hospital Discarded linen, mattresses, beddings contaminated with blood or body fluid to be put in Non-chlorinated yellow plastic bags or suitable packing material and Labeled with a Label mentioning the contents.

(h) Microbiology,

Biotechnology and

other clinical laboratory waste: Blood bags, Laboratory cultures, stocks or specimens of microorganisms, live or

Autoclave safe plastic bags or containers.

Pre-treat to sterilize with non-chlorinated chemicals on-site as per National AIDS Control Organisation or World Health Organisation guidelines thereafter for

To be put in a Autoclave Safe Bag (any Colour) Autoclaved & then put in a Yellow Bag and handed over to

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Category Type of Waste Type of Bag

or Container

to be Used

Treatment and

Disposal options

#Interpretation

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

attenuated vaccines, human and animal cell cultures used in research, industrial laboratories, production of biological, residual toxins, dishes and devices used for cultures.

Incineration. the operator of common Bio-medical Waste treatment facility.

Red Contaminated Waste

(Recyclable)

(a) Wastes generated from disposable items such as tubing, bottles, intravenous tubes and sets, catheters, urine bags, syringes (without needles and fixed needle syringes) and vacutainers with their

needles cut) and gloves.

Red coloured non-chlorinated plastic bags

or containers

Autoclaving or micro-waving/ hydroclaving followed by shredding or mutilation or combination of sterilization and shredding. Treated waste to be sent to 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.

No Pre-treatment, shredding/ mutilation required to be done by the hospital if handing over to the operator of common Bio-medical Waste treatment facility. Autoclaving or micro-waving/ hydroclaving followed by 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

or Container

to be Used

Treatment and

Disposal options

#Interpretation

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

facility.

White (Translucent)

Waste sharps including Metals: Needles, syringes with fixed needles, needles from needle tip cutter or burner, scalpels, blades, or any other contaminated sharp object that may cause puncture and cuts. This includes both used, discarded and contaminated

metal sharps

Puncture proof, Leak proof, tamper proof

containers

Autoclaving or Dry Heat Sterilization followed by shredding or mutilation or encapsulation in metal container or cement concrete; combination of shredding cum 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.

No Pre-treatment, shredding/ mutilation required to be done by the hospital if handing over to the operator of common Bio-medical Waste treatment facility.

Blue (a) Glassware: Broken or discarded and contaminated glass including medicine vials and ampoules except those contaminated with

cytotoxic wastes.

Cardboard boxes with blue coloured

marking

Disinfection (by soaking the washed glass waste after cleaning with detergent and Sodium Hypochlorite treatment) or through autoclaving or microwaving or hydroclaving and then

sent for recycling.

No Pre-treatment, required to be done by the hospital.

(b) Metallic Body

Implants

Cardboard boxes with blue 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 0C.

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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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 27th 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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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 27th 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 0C

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

B. Emission Standards

S. No. Parameter Standards

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

Limiting

concentration in

mg Nm3 unless

stated

Sampling Duration in

minutes, unless stated

1. Particulate matter 50 30 or 1NM3 of sample volume,

whichever is more

2. Nitrogen Oxides NO and NO2

expressed as NO2

400 30 for online sampling or grab sample

3. HCl 50 30 or 1NM3 of sample volume, whichever is more

4. Total Dioxins and

Furans

0.1ng TEQ/Nm3

(at 11% O2)

8 hours or 5NM3 of sample

volume, whichever is more

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5. Hg and its compounds

0.05 2 hours or 1NM3 of sample 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 CO2, CO and O2.

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 1X106 spores. Under no

circumstances will an autoclave have minimum operating parameters less than a

residence time of 30 minutes, a temperature less than 121oC 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 185oC,

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:

AREA wise

Quantity RED

YELLOW YELLOW

CYTOTOXIC BLUE

SHARP

CONTAINER

WHITE

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

Generated or

Collected, kg/day

Method of Treatment

and Disposal (Refer

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 (Translucent)

Waste sharps including Metals:

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

CBMWTF

: (State Government or Private or Semi Govt.

or any other)

(x) Status of Authorisation under

the Bio-Medical Waste

(Management and Handling)

Rules

: Authorisation No.:

………………………………………………

……valid up to ………

(xi) Status of Consents under

Water Act and Air Act

: Valid up to:

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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

disposal capacity of

CBMWTF:

: _______ Kg per day

(iv) Quantity of biomedical waste

treated or disposed by

CBMWTF

: _____ Kg/day

4. Quantity of waste generated or

disposed in Kg per annum (on

monthly average basis)

(#Interpretation – Month wise and Total Annual Quantity)

: Yellow Category:

Red Category:

White:

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

facility

Size:

Capacity:

Provision of on-site storage : (cold storage or

any other provision)

(ii) Disposal facilities Type of treatment equipment

No. of units

Capaci ty

Kg/day

Quantity treated or

disposed in kg per annum

Incinerators

Plasma Pyrolysis

Autoclaves

Microwave

Hydroclave

Shredder

Needle tip cutter

or destroyer

Sharps

encapsulation or concrete pit

Deep burial pits:

Chemical dis infection:

Any other treatment

equipment:

(iii)Quantity of recyclable wastes

sold to authorized recyclers after

treatment in kg per annum.

Red Category (like plastic, glass etc.)

(iv) No of vehicles used for collection

and transportation of biomedical

waste

(v) Details of incineration ash and

ETP sludge generated and

disposed during the treatment of

wastes in Kg per annum

Quantity generated

Where disposed

Incineration

Ash

ETP Sludge

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Standard Operating Procedure for

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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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Standard Operating Procedure for

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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.

No.

Audit Criteria for Weekly/Monthly Audit Yes/No Comments

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.

No.

Audit Criteria for Weekly/Monthly Audit Yes/No Comments

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.

No.

Audit Criteria for Weekly/Monthly Audit Yes/No Comments

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 3/4th 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.

No.

Audit Criteria for Weekly/Monthly Audit Yes/No Comments

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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S.

No.

Audit Criteria for Weekly/Monthly Audit Yes/No Comments

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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S.

No.

Audit Criteria for Weekly/Monthly Audit Yes/No Comments

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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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

or Container

to be Used

Treatment and

Disposal options

Yes/No

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

Yellow (a) Human Anatomical Waste: Human tissues, organs, body parts and foetus below the viability period (as per the Medical Termination of Pregnancy Act 1971, amended from

time to time).

Yellow coloured non-chlorinated

plastic bags

Incineration or Plasma Pyrolysis or

deep burial*

(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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Category Type of Waste Type of Bag

or Container

to be Used

Treatment and

Disposal options

Yes/No

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

animal houses.

(c) Soiled Waste: Items contaminated with blood, body fluids like dressings, plaster casts, cotton swabs and bags containing residual or discarded blood and blood

components.

Incineration or Plasma Pyrolysis or

deep burial*

In absence of above facilities, autoclaving or 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

Medicines: Pharmaceutical waste like antibiotics, cytotoxic drugs including all items contaminated with cytotoxic drugs along with glass or plastic

ampoules, vials etc.

Yellow coloured non-chlorinated plastic bags

or containers

Expired `cytotoxic drugs and items contaminated with cytotoxic drugs to be returned back to the manufacturer or supplier for incineration at 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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Category Type of Waste Type of Bag

or Container

to be Used

Treatment and

Disposal options

Yes/No

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

>12000C.

All other discarded medicines shall be either sent back to manufacturer or disposed by

incineration.

(e) Chemical Waste: Chemicals used in production of biological and used or discarded

disinfectants

Yellow coloured containers or non-chlorinated

plastic bags

Disposed of by incineration or Plasma Pyrolysis or Encapsulation in hazardous waste treatment, storage

and disposal facility.

(f) Chemical Liquid Waste: Liquid waste generated due to use of chemicals in production of biological and used or discarded disinfectants, Silver X-ray film developing liquid, discarded Formalin, infected secretions, aspirated body fluids, liquid from laboratories and floor washings, cleaning, housekeeping and disinfecting activities

etc.

Separate collection system leading to effluent treatment

system

After resource recovery, the chemical liquid waste shall be pre-treated before mixing with other wastewater. The combined discharge shall conform to the discharge norms given in Schedule-

III.

(g) Discarded linen, mattresses, beddings contaminated with blood

or body fluid.

Non-chlorinated yellow plastic bags or suitable packing

Non- chlorinated chemical disinfection followed by incineration or Plazma Pyrolysis or

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Category Type of Waste Type of Bag

or Container

to be Used

Treatment and

Disposal options

Yes/No

(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,

Biotechnology and other

clinical laboratory waste: Blood bags, Laboratory cultures, stocks or specimens of microorganisms, live or attenuated vaccines, human and animal cell cultures used in research, industrial laboratories, production of biological, residual toxins, dishes and devices used for cultures.

Autoclave safe plastic bags or

containers.

Pre-treat to sterilize with non-chlorinated chemicals on-site as per National AIDS Control Organisation or World Health Organisation guidelines thereafter

for Incineration.

Red Contaminated Waste

(Recyclable)

Wastes generated from disposable items such as tubing, bottles, intravenous tubes and sets, catheters, urine bags, syringes (without needles and fixed needle syringes) and vacutainers with their needles cut) and gloves.

Red coloured non-chlorinated plastic bags or containers

Autoclaving or micro-waving/ hydroclaving followed by shredding or mutilation or combination of sterilization and shredding. Treated waste to be sent to

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Category Type of Waste Type of Bag

or Container

to be Used

Treatment and

Disposal options

Yes/No

(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

(Translucent) Waste sharps including Metals: Needles, syringes with fixed needles, needles from needle tip cutter or burner, scalpels, blades, or any other contaminated sharp object that may cause puncture and cuts. This includes both used, discarded and contaminated metal

sharps

Puncture proof, Leak proof, tamper proof

containers

Autoclaving or Dry Heat Sterilization followed by shredding or mutilation or encapsulation in metal container or cement concrete; combination of shredding cum 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 discarded and contaminated glass including medicine vials

Cardboard boxes with blue coloured

Disinfection (by soaking the washed glass waste after cleaning with

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Standard Operating Procedure for

Bio Medical Waste Management

This document contains proprietary information of FORTIS HEALTHCARE LTD

For internal circulation only

Category Type of Waste Type of Bag

or Container

to be Used

Treatment and

Disposal options

Yes/No

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

and ampoules except those contaminated with cytotoxic wastes.

marking detergent and Sodium Hypochlorite treatment) or through autoclaving or microwaving or hydroclaving and then sent for

recycling.

(b) Metallic Body Implants Cardboard boxes with blue coloured

marking

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