FORTIS HEALTHCARE LIMITED Standard Operating Procedure for
P age 1 o f 80
Bio Medical Waste Management
STANDARD OPERATING PROCEDURE
BIO MEDICAL WASTE MANAGEMENT SOP Number: Version Number:
BMW-P-2016-1.1 1.1
Effective Date:
1st July Supersedes 2016 Version:
Prepared By:
Dr Ravneet Kaur, Dr Anita Arora, Dr Anita Sharma
Reviewe d By:
Dr Akash Sud
Approved By:
Next 31st Review March Date: 2017 Dr Bishnu Panigrahi BMW-P2016-1.0
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FORTIS HEALTHCARE LIMITED
P age 2 o f 80
Standard Operating Procedure for Bio Medical Waste Management
Table of Contents S. No.
Section
Page
I
Change Control Information
4
II
Functional Organizational Structure
5
III
Scope & Objectives
6
IV
Common Abbreviations
7
V
Definitions
8
VI
Involved Personnel (Roles & Responsibilities)
9
VII
Flowchart
10
VIII
Process
10
01.
Duties of the Occupier
11
02.
Bio-Medical Waste Management
15
03.
Segregation Of Waste
24
04.
Waste Removal & Transportation
26
05.
Treatment and Disposal
28
06.
Waste Storage & Transportation to Waste Treatment Facility
32
07.
Licensing & Other requirements for Bio-medical Waste
34
management 08.
Minimum terms of Service Level Agreement with the Vendor
40
09.
Biomedical Waste Audit
42
Annex 1
Labels for Biomedical waste containers/bags
44
Annex 2
Labels for transport of Biomedical waste containers/bags
45
Annex 3
Standards for treatment and disposal of Biomedical waste
46
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P age 3 o f 80
Standard Operating Procedure for Bio Medical Waste Management
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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FORTIS HEALTHCARE LIMITED Standard Operating Procedure for
P age 4 o f 80
Bio Medical Waste Management
I. Change Control Information
Version Number: Changes Made:
1.1
Effective Date:
1st July Supersedes 2016 Version: Reason change:
BMW-P2016-1.0
Next Review Date: for Adding Interpretations received from CPCB Dt 08/06/2016
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FORTIS HEALTHCARE LIMITED Standard Operating Procedure for
P age 5 o f 80
Bio Medical Waste Management
II. Functional Organizational Structure (Organogram) (TO BE DEVELOPED BY FACILITY)
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P age 6 o f 80
Bio Medical Waste Management
III. Scope and Objectives of process
The goal of the department is...
To ensure that biomedical waste is handled and disposed in a safe manner
The scope and complexity of services
Biomedical waste is generated in all patient care
provided by this department is...
areas and needs to be managed as per the applicable statutory regulations
The methods used in order to customize services are....
Biomedical waste segregation Biomedical waste storage till transportation to final treatment/disposal site
The extent to which the level of care/
Color coded waste disposal bags are
services provided meets customer needs are:
conveniently available at waste generation sites. Waste is stored and transported in closed bags/bins to central area where it is kept till collected for final disposal.
Regulatory agencies relevant to this
State Pollution Control Board
service… Staffing plan is...
Supervisor – 1 GDA/Housekeeping - as required
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FORTIS HEALTHCARE LIMITED Standard Operating Procedure for
P age 7 o f 80
Bio Medical Waste Management
IV. Common Abbreviations
Sl. No. 1
Abbreviation
Full Form
Listed in each process
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FORTIS HEALTHCARE LIMITED Standard Operating Procedure for
P age 8 o f 80
Bio Medical Waste Management
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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P age 9 o f 80
Standard Operating Procedure for Bio Medical Waste Management
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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FORTIS HEALTHCARE LIMITED Standard Operating Procedure for
P age 1 0 of 80
Bio Medical Waste Management
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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FORTIS HEALTHCARE LIMITED Standard Operating Procedure for
P age 1 1 of 80
Bio Medical Waste Management
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; This document contains proprietary information of FORTIS HEALTHCARE LTD For internal circulation only
FORTIS HEALTHCARE LIMITED Standard Operating Procedure for
P age 1 2 of 80
Bio Medical Waste Management
(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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FORTIS HEALTHCARE LIMITED Standard Operating Procedure for
P age 1 3 of 80
Bio Medical Waste Management
(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; This document contains proprietary information of FORTIS HEALTHCARE LTD For internal circulation only
FORTIS HEALTHCARE LIMITED Standard Operating Procedure for
P age 1 4 of 80
Bio Medical Waste Management
(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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FORTIS HEALTHCARE LIMITED
P age 1 5 of 80
Standard Operating Procedure for Bio Medical Waste Management
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
(1)
(2)
(3)
(4)
(a) Human Anatomical Waste: Human tissues, organs, body parts and foetus below the viability period (as per the Medical Termination of
Yellow coloured nonchlorinated plastic bags
Incineration or Plasma Pyrolysis or deep burial*
Yellow
#
Interpretation
(5) No Pretreatment required to be done in the hospital.
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P age 1 6 of 80
Standard Operating Procedure for Bio Medical Waste Management
#
Category
Type of Waste
Type of Bag or Container to be Used
Treatment and Disposal options
Interpretation
(1)
(2)
(3)
(4)
(5)
Incineration or Plasma Pyrolysis or deep burial*
No Pretreatment required to be done in the hospital, except for Blood Bags which need to be Autoclaved.
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.
(d) Expired or Discarded Medicines: Pharmaceutical waste like antibiotics, cytotoxic drugs including all items contaminated with cytotoxic drugs along
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. Yellow coloured nonchlorinated 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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FORTIS HEALTHCARE LIMITED
P age 1 7 of 80
Standard Operating Procedure for Bio Medical Waste Management
#
Category
Type of Waste
Type of Bag or Container to be Used
Treatment and Disposal options
(1)
(2)
(3)
(4)
(5)
temperature >1200 0C or to common biomedical waste treatment facility or hazardous waste treatment, storage and disposal facility for incineration at >12000C Or Encapsulation or Plasma Pyrolysis at >12000C.
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 Biomedical Waste treatment facility.
with glass or plastic ampoules, vials etc.
All other discarded medicines shall be either sent back to manufacturer or disposed by incineration.
Interpretation
(e) Chemical Waste: Chemicals used in production of biological and used or discarded disinfectants
Yellow coloured containers or nonchlorinated plastic bags
Disposed of by incineration or Plasma Pyrolysis or Encapsulation in hazardous waste treatment, storage and disposal facility.
No Pretreatment 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 Xray 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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FORTIS HEALTHCARE LIMITED
P age 1 8 of 80
Standard Operating Procedure for Bio Medical Waste Management
Category
Type of Waste
Type of Bag or Container to be Used
Treatment and Disposal options
(1)
(2)
(3)
(4)
secretions, aspirated body fluids, liquid from laboratories and floor washings, cleaning, housekeeping and disinfecting activities etc. (g) Discarded linen, mattresses, beddings contaminated with blood or body fluid.
(h) Microbiology, Biotechnology and other clinical laboratory waste: Blood bags, Laboratory cultures, stocks or specimens of microorganisms, live or
#
Interpretation
(5)
in Schedule- III.
given in Schedule - II, to be ascertained by the Prescribed authorities.
Nonchlorinated yellow plastic bags or suitable packing material
Non- chlorinated chemical disinfection followed by incineration or Plazma Pyrolysis or for energy recovery.
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
No Pretreatment, shredding/ mutilation required to be done in the hospital Discarded linen, mattresses, beddings contaminated with blood or body fluid to be put in Nonchlorinated yellow plastic bags or suitable packing material and Labeled with a Label mentioning the contents. To be put in a Autoclave Safe Bag (any Colour) Autoclaved & then put in a Yellow Bag and handed over to
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.
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FORTIS HEALTHCARE LIMITED
P age 1 9 of 80
Standard Operating Procedure for Bio Medical Waste Management
Category
Type of Waste
Type of Bag or Container to be Used
Treatment and Disposal options
(1)
(2)
(3)
(4)
attenuated vaccines, human and animal cell cultures used in research, industrial laboratories, production of biological, residual toxins, dishes and devices used for cultures. 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 nonchlorinated plastic bags or containers
#
Interpretation
(5)
Incineration.
the operator of common Biomedical Waste treatment facility.
Autoclaving or microwaving/ 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.
No Pretreatment, shredding/ mutilation required to be done by the hospital if handing over to the operator of common Biomedical 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 Biomedical Waste treatment
Plastic waste should not be sent to landfill sites.
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FORTIS HEALTHCARE LIMITED
P age 2 0 of 80
Standard Operating Procedure for Bio Medical Waste Management
Category
Type of Waste
Type of Bag or Container to be Used
Treatment and Disposal options
(1)
(2)
(3)
(4)
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.
(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
(b) Metallic Body Implants
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.
White Waste sharps including (Translucent) 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
Blue
#
Interpretation
(5) facility. No Pretreatment, shredding/ mutilation required to be done by the hospital if handing over to the operator of common Biomedical Waste treatment facility.
No Pretreatment, required to be done by the hospital.
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FORTIS HEALTHCARE LIMITED Standard Operating Procedure for
P age 2 1 of 80
Bio Medical Waste Management
*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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FORTIS HEALTHCARE LIMITED Standard Operating Procedure for
P age 2 2 of 80
Bio Medical Waste Management
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 biomedical waste treatment and disposal facility or TSDFs or plasma pyrolysis at temperature >1200 0 C.
9. Residual or discarded chemical wastes, used or discarded disinfectants and chemical sludge can be disposed at hazardous waste treatment, storage and disposal facility. In such case, the waste should be sent to hazardous waste treatment, storage and disposal facility through operator of common bio-medical waste treatment and disposal facility only. #
Interpretation – Residual or discarded chemical wastes or discarded disinfectants means any
un-used/expired/waste chemicals like acids or alkalis or disinfectants. Chemical sludge means sludge removed from the Pre-treatment tank or the scaling removed from the pre-treatment tank whenever it is cleaned.
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FORTIS HEALTHCARE LIMITED Standard Operating Procedure for
P age 2 3 of 80
Bio Medical Waste Management
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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FORTIS HEALTHCARE LIMITED Standard Operating Procedure for
P age 2 4 of 80
Bio Medical Waste Management
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. This document contains proprietary information of FORTIS HEALTHCARE LTD For internal circulation only
FORTIS HEALTHCARE LIMITED Standard Operating Procedure for
P age 2 5 of 80
Bio Medical Waste Management
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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FORTIS HEALTHCARE LIMITED Standard Operating Procedure for
P age 2 6 of 80
Bio Medical Waste Management
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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FORTIS HEALTHCARE LIMITED Standard Operating Procedure for
P age 2 7 of 80
Bio Medical Waste Management
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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FORTIS HEALTHCARE LIMITED Standard Operating Procedure for
P age 2 8 of 80
Bio Medical Waste Management
Biomedical Waste Management BMW / SOP No. 05 ________________________________________________________________ Title: Treatment and Disposal
Objective: To Pre-Treat Chemical liquid waste, Microbiology waste & other Lab waste, including Blood Bags
Job Responsibility: Lab Staff, Blood Bank Staff, Engineering, Housekeeping & Security
Description: 1. Bio-medical waste shall be pre-treated and disposed of in accordance with Table I, and in compliance with the standards provided in Annexure 3, by the health care facilities
2. Occupier shall hand over segregated waste as per the Table I to common bio medical waste treatment facility for treatment, processing and final disposal: Provided that the lab and highly infectious bio-medical waste generated shall be pre-treated by equipment like autoclave or microwave.
3. No occupier shall establish on-site treatment and disposal facility, if a service of common bio-medical waste treatment facility is available at a distance of seventy-five kilometre.
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4. Any person including an occupier or operator of a common bio medical waste treatment facility, intending to use new technologies for treatment of bio medical waste other than those listed in Schedule I shall request the Central Government for laying down the standards or operating parameters.
5. Every occupier shall phase out use of non-chlorinated plastic bags within two years from the date of publication of Bio-Medical Waste Management Rules, 2016 (i. e. latest by 27th March 2018) and thereafter, the chlorinated plastic bags shall not be used for storing and transporting of bio-medical waste and the bags used for storing and transporting biomedical waste shall be in compliance with the Bureau of Indian Standards. Till the Standards are published, the carry bags shall be as per the Plastic Waste Management Rules, 2011. 6. After ensuring treatment by autoclaving or microwaving followed by mutilation or shredding, whichever is applicable, the recyclables from the treated bio-medical wastes such as plastics and glass shall be given to such recyclers having valid authorisation or registration from the respective prescribed authority. #
Interpretation – Mutilation or shredding is to be done by the operator of common Bio-medical
Waste treatment facility.
7. The Occupier or Operator of a common bio-medical waste treatment facility shall maintain a record of recyclable wastes referred to in sub-rule (9) which are auctioned or sold and the same shall be submitted to the prescribed authority as part of its annual report. The record shall be open for inspection by the prescribed authorities. #
Interpretation – Not applicable for Hospitals handing over ‘Contaminated Waste (Recyclable)’
to the operator of common Bio-medical Waste treatment facility.
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8. The handling and disposal of all the mercury waste and lead waste shall be in accordance with the respective rules and regulations. 9. Microbiology waste and all other clinical laboratory waste shall be pre-treated by sterilisation to Log 6 or disinfection to Log 4, as per the World Health Organisation guidelines before packing and sending to the common bio-medical waste treatment facility. #
Interpretation – pre-treated by sterilization to Log 6 or disinfection to Log 4 can be achieved
by Autoclaving and validation for the same can be done through Routine Test (at least one Class 1Chemical indicator/Process Indicator in each Cycle) & Spore Testing (Biological Indicator once a week) described in the Standards of Autoclaving. The records for the same to be maintained for 5 years.
10. Chemical treatment using at least 10% Sodium Hypochlorite having 30% residual chlorine for twenty minutes or any other equivalent chemical reagent that should demonstrate Log104 reduction efficiency for microorganisms as given in Annexure 3. #
Interpretation – Using 10% Sodium Hypochlorite is enough as it contains at least 30%
Residual Chlorine. Hospital is not essential to measure 30% residual Chlorine if hospital is using 10% Sodium Hypochlorite.
11. There will be no on site chemical pre-treatment except for Microbiology, Biotechnology and other clinical laboratory waste listed under category (h) of the waste to be disposed in Yellow category in Table 1, and highly infectious waste. 12. Residual or discarded chemical wastes, used or discarded disinfectants and chemical sludge can be disposed at hazardous waste treatment, storage and disposal facility. In such case, the waste should be sent to hazardous waste treatment, storage and disposal facility through operator of common bio medical waste treatment and disposal facility only. This document contains proprietary information of FORTIS HEALTHCARE LTD For internal circulation only
FORTIS HEALTHCARE LIMITED Standard Operating Procedure for
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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 biomedical waste treatment and disposal facility. 14. Syringes should be either mutilated or needles should be cut and or stored in tamper proof, leak proof and puncture proof containers for sharps storage. Wherever the occupier is not linked to a disposal facility it shall be the responsibility of the occupier to sterilize and dispose in the manner prescribed. #
Interpretation – No mutilation of syringes or cutting of needles required to be done by the
hospital if handing over to the operator of common Bio-medical Waste treatment facility
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Biomedical Waste Management BMW / SOP No. 06 ________________________________________________________________ Title: Waste storage & Transportation to Waste Treatment Facility Objective: Waste storage and transport to Waste treatment facility. Job Responsibility: Housekeeping Staff / Security Supervisor / Housekeeping Supervisor / Outsourced Agency
Frequency: Ideally daily, but definitely within 48 hrs for at least untreated human anatomical waste, animal anatomical waste, soiled waste and biotechnology waste.
Description: 1. Bio-medical waste should not be mixed with other waste. There should be a clear physical differentiation between the storage areas of general and Bio-medical waste 2. The Bio-medical waste should be stored in safe, ventilated and secured location for storage of segregated biomedical waste in Coloured Bags or containers as per colour coding norms. These containers and the bags should have the hazard symbols as per Annexure 1. 3. Establish a Bar-Code System for bags or containers containing bio-medical waste to be sent out of the premises or place for any purpose within one year from the date of the notification of these rules. (i. e. latest by 27 th March 2017).
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4. At the time of collection of general waste and bio-medical waste from the Central Garbage area by the contracted waste removal agency, Security Supervisor or Housekeeping Supervisor must be present and ensure that there is no mixing of different types of waste. 5. Weighing will be done at the central area and weight mentioned on a register maintained for this purpose. 6. When the container/bags are to be transported from the premises where the Bio-medical waste is generated to the authorized Waste Treatment Facility outside the premises, the container/bag shall, apart from the label as per Annexure 1, also carry information prescribed in Annexure 2. These Bags/Containers shall also carry Bar Code, once the Bar-Coding system is established (latest by 27th March 2017). 7. Bio-medical Waste shall be transported only in such vehicle as may be authorized for the purpose (Ref Housekeeping SOP on Garbage Removal & Transportation) This vehicle would be supplied by the authorized, contracted Waste Disposal agency. 8. Untreated
human anatomical waste, animal anatomical waste, soiled waste and,
biotechnology waste shall not be stored beyond a period of forty –eight hours: Provided that in case for any reason it becomes necessary to store such waste beyond such a period, the occupier shall take appropriate measures to ensure that the waste does not adversely affect human health and the environment and inform the prescribed authority along with the reasons for doing so. 9. Inform the prescribed authority immediately in case the operator of a facility does not collect the bio-medical waste within the intended time or as per the agreed time.
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Biomedical Waste Management BMW / SOP No. 07 ________________________________________________________________
Title: Licensing & Other requirements for Bio-medical Waste Management
Objective: Licensing & Other requirements for Bio-medical Waste management
Job Responsibility: Head- Administration
Frequency: As per prescribed timelines
Description: 1. Application for Authorization a. Every occupier handling bio-medical waste, irrespective of the quantity shall make an application in Form II (Annexure 5) to the prescribed authority i.e. State Pollution Control Board and Pollution Control Committee, as the case may be, for grant of authorisation and the prescribed authority shall grant the provisional authorisation in Form III (Annexure 6) and the validity of such authorisation for bedded health care facility shall be synchronised with the validity of the consents . b. Disposal of this application shall be done by the authority (Pollution Control Board in states or Pollution Control Committee in union territories, as the case may be)
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within 90 days from the date of receipt, failing which it shall be deemed that the authorisation is granted under the Biomedical Waste Management Rules. c. In case of any change in the bio-medical waste generation, handling, treatment and disposal for which authorisation was earlier granted, the occupier or operator shall intimate to the prescribed authority about the change or variation in the activity and shall submit a fresh application in Form II (Annexure 5) for modification of the conditions of authorisation. d. Occupier should apply for Renewal at least 3 months prior to expiry of the Authorization. 2. Annual Report a. Every occupier or operator of common bio-medical waste treatment facility shall submit an Annual Report to the prescribed authority in Form-IV (Annexure 7) on or before the 30th June of every year. The prescribed authority shall compile, review and analyse the information received and send this information to the Central Pollution Control Board on or before the 31st July of every year. b. The Annual Reports shall also be made available online on the websites of Occupier & all healthcare facilities shall make own website within two years from the date of notification of Bio-Medical Waste Management Rules, 2016 (i.e. latest by 27th March 2018). c. The annual report shall also contain i.
Number of Beds (# Interpretation – Census or Registered Beds)
ii. Category wise quantity of waste generated or disposed in Kgs per annum (on monthly average basis). (# Interpretation – Month wise and Total Annual Quantity) iii. General Solid Waste (# Interpretation – Estimated Quantity is to be given) iv. Details of the Storage, treatment, transportation, processing and Disposal Facility
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#
Interpretation – Only Point No. (vi) is to be filled by the (Hospital) Occupier (if waste
is being handed over to the operator of common Bio-medical Waste treatment facility) & rest of the points are for the operator of common Bio-medical Waste treatment facility.
v. Minutes of Meeting of the Bio-Medical Waste Management Committee (Subcommittee 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, HeadAdmin, 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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Biomedical Waste Management BMW / SOP No. 08 ________________________________________________________________ Title: Minimum terms of Service Level Agreement with the Vendor The service level Agreement with the Vendor must as a minimum state that the vendor shall: (a)
Take all necessary steps to ensure that the bio-medical waste collected from the hospital is transported, handled, stored, treated and disposed of, without any adverse effect to the human health and the environment, in accordance with these rules and guidelines issued by the Central Government or, as the case may be, the central pollution control board from time to time;
(b)
Ensure timely collection of bio-medical waste from the hospital as prescribed under Biomedical Waste Management Rules, 2016.
(c)
Ensure collection of biomedical waste (preferably) on each day including on holidays also, but at least once every 48 Hours;
(d)
Establish bar coding and global positioning system for handling of bio- medical waste within one year; (i.e. latest by 27 th March 2017)
(e)
Assist the hospital in training conducted by them for bio-medical waste management;
(f)
Allow the hospital, to inspect and see whether the treatment is carried out as per the rules by the operator at his premises;
(g)
Display details of authorisation, treatment, annual report etc. on vendor’s web-site;
(h)
Supply non-chlorinated plastic coloured bags to the hospital on chargeable basis, if required;
(i)
Transport the bio-medical waste from the hospital premises to any off-site bio-medical waste treatment facility only in the vehicles having label as provided in part ‘A’ of the
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Schedule IV (Annexure 1) along with necessary information as specified in part ‘B’ of the Schedule IV (Annexure 2). (j)
The vehicles used for transportation of bio-medical waste shall comply with the conditions if any stipulated by the State Pollution Control Board or Pollution Control Committee in addition to the requirement contained in the Motor Vehicles Act, 1988 (59 of 1988), if any or the rules made there under for transportation of such infectious waste.
(k)
Submit a copy of the vendor’s authorization by the State Authority & the list of authorized vehicles. In case of any change in the authorization status, or change in authorized vehicles, the vendor shall inform the hospital,
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Biomedical Waste Management BMW / SOP No. 09 ________________________________________________________________ Title: Biomedical Waste Audit
Objective: Biomedical Waste Audit
Job Responsibility: Medical Superintendent, Infection Control Nurse & Officer, members nominated by HICC.
Frequency: Weekly audit for at least one high risk area, monthly audit for the entire hospital for process compliance & six monthly audit for waste transport and treatment facility
Description: 1. The hospital will carry out weekly audit for assessing compliance to biomedical waste segregation and handling using the BMW Audit tool in at least one high risk area (ANNEXURE 9). 2. Although the weekly audit will be for a single area (e.g. OT or CSSD or Dialysis etc), the audits should be planned in such a manner that all high risk areas of the hospital are covered regularly.
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3. In addition, there will be a comprehensive Audit of the entire hospital preferably within the first two weeks of every month. 4. Audit will be the responsibility of a team nominated by the Hospital Infection Control Committee (e.g. ICN for wards, Microbiologist/MS for OT & ICU, AMS for CSSD, Cath Lab, Head Admin for HK areas, Laundry & Linen room, etc.). 5. Additionally, an audit of the biomedical waste transport and treatment facility will be carried out at least once in six months. 6. The checklist provided in Annexure 8 will be used for audits. Units can make minor modifications or additions to the checklist (no deletions allowed) to meet statutory regulations (since these vary from state to state). 7. The completed audit sheets are to be kept for a period of at least 5 years along with other Bio-Medical waste records. 8. Audit findings are to be presented in the Infection Control Committee meetings and documented in the minutes of the meeting.
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ANNEXURE: 1 LABEL FOR BIO-MEDICAL WASTE CONTAINERS/BAGS
Note: Label shall be non-washable and prominently visible.
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ANNEXURE: 2 LABEL FOR TRANSPORT OF BIO-MEDICAL WASTE CONTAINERS/BAGS
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ANNEXURE: 3 STANDARDS FOR TREATMENT & DISPOSAL OF BIO-MEDICAL WASTES 1. STANDARD FOR INCINERATION:All incinerators shall meet the following operating and emission standards-
A. Operating Standards (1) Combustion efficiency (CE) shall be at least 99.00%. (2) The Combustion efficiency is computed as follows: %CO2 CE = --------------------%CO2 + % CO
X 100
(3) The temperature of the primary chamber shall be a minimum of 800 0 C and the secondary chamber shall be minimum of 1050 0 C + 50 0 C.
B. Emission Standards
S. No. (1)
Parameter (2)
Standards (3) Limiting concentration in mg Nm3 unless stated 50
1.
Particulate matter
2.
Nitrogen Oxides NO and NO 2 expressed as NO2 HCl
400
Total Dioxins and Furans
0.1ng TEQ/Nm3 (at 11% O2)
3. 4.
50
(4) Sampling Duration in minutes, unless stated 30 or 1NM3 of sample volume, whichever is more 30 for online sampling or grab sample 30 or 1NM3 of sample volume, whichever is more 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 This document contains proprietary information of FORTIS HEALTHCARE LTD For internal circulation only
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of in municipal landfill, if the toxic metals in incineration ash are within the regulatory quantities as defined under the Hazardous Waste (Management and Handling and Transboundary Movement) Rules, 2008 as amended from time to time. (g) Only low Sulphur fuel like Light Diesel Oil or Low Sulphur Heavy Stock or Diesel, Compressed Natural Gas, Liquefied Natural Gas or Liquefied Petroleum Gas shall be used as fuel in the incinerator. (h) The occupier or operator of a common bio-medical waste treatment facility shall monitor the stack gaseous emissions (under optimum capacity of the incinerator) once in three months through a laboratory approved under the Environment (Protection) Act, 1986 and record of such analysis results shall be maintained and submitted to the prescribed authority. In case of dioxins and furans, monitoring should be done once in a year. (i) The occupier or operator of the common bio-medical waste treatment facility shall install continuous emission monitoring system for the parameters as stipulated by State Pollution Control Board or Pollution Control Committees in authorisation and transmit the data real time to the servers at State Pollution Control Board or Pollution Control Committees and Central Pollution Control Board. (j) All monitored values shall be corrected to 11% Oxygen on dry basis. (k) Incinerators (combustion chambers) shall be operated with such temperature, retention time and turbulence, as to achieve Total Organic Carbon content in the slag and bottom ashes less than 3% or their loss on ignition shall be less than 5% of the dry weight.
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(l) The occupier or operator of a common bio-medical waste incinerator shall use combustion gas analyser to measure CO 2 , CO and O 2 . 2. Operating
and Emission Standards
for Disposal by
Plasma Pyrolysis or
Gasification: A. Operating Standards: All the operators of the Plasma Pyrolysis or Gasification shall meet the following operating and emission standards: (1) Combustion Efficiency (CE) shall be at least 99.99%. (2) The Combustion Efficiency is computed as follows: %CO2 CE = --------------------- X 100 %CO2 + % CO (3) The temperature of the combustion chamber after plasma gasification shall be 1050 ± 50o C with gas residence time of at least 2 (two) second, with minimum 3 % Oxygen in the stack gas. (4) The Stack height should be minimum of 30 m above ground level and shall be attached
with the necessary monitoring facilities as per
requirement of monitoring of ‘general parameters’ as notified under the Environment (Protection) Act, 1986 and in accordance with the CPCB Guidelines of Emission Regulation Part-III. B. Air Emission Standards and Air Pollution Control Measures (i)
Emission standards for incinerator, notified at Sl No.1 above in this Schedule, and revised from time to time, shall be applicable for the Plasma Pyrolysis or Gasification also.
(ii)
Suitably designed air pollution control devices shall be installed or retrofitted with the ‘Plasma Pyrolysis or Gasification to achieve the above emission limits, if necessary.
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(iii)
Wastes to be treated using Plasma Pyrolysis or Gasification shall not be chemically treated with any chlorinated disinfectants and chlorinated plastics shall not be treated in the system.
C. Disposal of Ash Vitrified Material The ash or vitrified material generated from the ‘Plasma Pyrolysis or Gasification shall be disposed-off in accordance with the Hazardous Waste (Management, Handling and Transboundary Movement) Rules 2008 and revisions made thereafter in case the constituents exceed the limits prescribed under Schedule II of the said Rules or else in accordance with the provisions of the Environment (Protection) Act, 1986, whichever is applicable.
3. STANDARDS FOR AUTOCLAVING OF BIO-MEDICAL WASTE The autoclave should be dedicated for the purposes of disinfecting and treating biomedical waste. (1) When operating a gravity flow autoclave, medical waste shall be subjected to: (i)
a temperature of not less than 121° C and pressure of 15 pounds per square inch (psi) for an autoclave residence time of not less than 60 minutes; or
(ii)
a temperature of not less than 135° C and a pressure of 31 psi for an autoclave residence time of not less than 45 minutes; or
(iii)
a temperature of not less than 149° C and a pressure of 52 psi for an autoclave residence time of not less than 30 minutes.
(2) When operating a vacuum autoclave, medical waste shall be subjected to a minimum of three pre-vacuum pulse to purge the autoclave of all air. The air removed during the pre-vacuum, cycle should be decontaminated by means of HEPA and activated carbon filtration, steam treatment, or any other method to prevent release of pathogen. The waste shall be subjected to the following:
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(i)
a temperature of not less than 121°C and pressure of 15 psi per an autoclave residence time of not less than 45 minutes; or
(ii)
a temperature of not less than 135°C and a pressure of 31 psi for an autoclave residence time of not less than 30 minutes;
(3) Medical waste shall not be considered as properly treated unless the time, temperature and pressure indicators indicate that the required time, temperature and pressure were reached during the autoclave process. If for any reasons, time temperature or pressure indicator indicates that the required temperature, pressure or residence time was not reached, the entire load of medical waste must be autoclaved again until the proper temperature, pressure and residence time were achieved. (4) Recording of operational parameters: Each autoclave shall have graphic or computer recording devices which will automatically and continuously monitor and record dates, time of day, load identification number and operating parameters throughout the entire length of the autoclave cycle. (5) Validation test for autoclave: The validation test shall use four biological indicator strips, one shall be used as a control and left at room temperature, and three shall be placed in the approximate centre of three containers with the waste. Personal protective equipment (gloves, face mask and coveralls) shall be used when opening containers for the purpose of placing the biological indicators. At least one of the containers with a biological indicator should be placed in the most difficult location for steam to penetrate, generally the bottom centre of the waste pile. The occupier or operator shall conduct this test three consecutive times to define
the minimum operating conditions.
The temperature,
pressure and
residence time at which all biological indicator vials or strips for three consecutive tests show complete inactivation of the spores shall define the minimum operating conditions for the autoclave.
After determining the minimum temperature,
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pressure and residence time, the occupier or operator of a common biomedical waste treatment facility shall conduct this test once in three months and records in this regard shall be maintained. (6) Routine Test: A chemical indicator strip or tape that changes colour when a certain temperature is reached can be used to verify that a specific temperature has been achieved. It may be necessary to use more than one strip over the waste package at different locations to ensure that the inner content of the package has been adequately autoclaved. The occupier or operator of a common bio medical waste treatment facility shall conduct this test during autoclaving of each batch and records in this regard shall be maintained. (7) Spore testing: The autoclave should completely and consistently kill the approved biological indicator at the maximum design capacity of each autoclave unit. Biological indicator for autoclave shall be Geobacillusstearothermophilus spores using vials or spore Strips; with at least 1X10 6 spores. Under no circumstances will an autoclave have minimum operating parameters less than a residence time of 30 minutes, a temperature less than 121o C or a pressure less than 15 psi. The occupier or operator of a common bio medical waste treatment and disposal facility shall conduct this test at least once in every week and records in this regard shall be maintained.
4. STANDARDS OF MICROWAVING: (1) Microwave treatment shall not be used for cytotoxic, hazardous or radioactive wastes, contaminated animal carcasses, body parts and large metal items. (2) The microwave system shall comply with the efficacy test or routine tests and a performance guarantee may be provided by the supplier before operation of the limit.
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(3) The microwave should completely and consistently kill the bacteria and other pathogenic organisms that are ensured by approved biological indicator at the maximum design capacity of each microwave unit. Biological indicators for microwave shall be Bacillus atrophaeusspores using vials or spore strips with at least 1 x 104sporesper detachable strip. The biological indicator shall be placed with waste and exposed to same conditions as the waste during a normal treatment cycle.
5. STANDARDS FOR DEEP BURIAL (1) A pit or trench should be dug about two meters deep. It should be half filled with waste, then covered with lime within 50 cm of the surface, before filling the rest of the pit with soil. (2) It must be ensured that animals do not have any access to burial sites. Covers of galvanised iron or wire meshes may be used. (3) On each occasion, when wastes are added to the pit, a layer of 10 cm of soil shall be added to cover the wastes. (4) Burial must be performed under close and dedicated supervision. (5) The deep burial site should be relatively impermeable and no shallow well should be close to the site. (6) The pits should be distant from habitation, and located so as to ensure that no contamination occurs to surface water or ground water. The area should not be prone to flooding or erosion. (7) The location of the deep burial site shall be authorised by the prescribed authority. (8) The institution shall maintain a record of all pits used for deep burial. (9) The ground water table level should be a minimum of six meters below the lower level of deep burial pit.
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Standard Operating Procedure for Bio Medical Waste Management
6. STANDARDS FOR EFFICACY OF CHEMICAL DISINFECTION Microbial inactivation efficacy is equated to “Log10 kill” which is defined as the difference between the logarithms of number of test microorganisms before and after chemical treatment. Chemical disinfection methods shall demonstrate a 4 Log10 reduction or greater for Bacillus Subtilis (ATCC 19659) in chemical treatment systems.
7. STANDARDS FOR DRY HEAT STERILIZATION Waste sharps can be treated by dry heat sterilization at a temperature not less than 185 o C, at least for a residence period of 150 minutes in each cycle, which sterilization period of 90
minutes.
There should be automatic recording system to monitor operating
parameters. (i)
Validation test for Sharps sterilization unit Waste sharps sterilization unit should completely and consistently kill the biological
indicator
Geobacillus
Stearothermophillus
or
Bacillus
Atropheausspoers using vials with at least log10 6 spores per ml. The test shall be carried out once in three months. (ii)
Routine test A chemical indicator strip or tape that changes colour when a certain temperature is reached can be used to verify that a specific temperature has been achieved. It may be necessary to use more than one strip over the waste to ensure that the inner content of the sharps has been adequately disinfected. This test shall be performed once in week and records in this regard shall be maintained.
8. STANDARDS FOR LIQUID WASTE (1) The effluent generated or treated from the premises of occupier or operator of a common bio medical waste treatment and disposal facility, before discharge into the sewer should conform to the following limits-
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FORTIS HEALTHCARE LIMITED Standard Operating Procedure for
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Bio Medical Waste Management
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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Standard Operating Procedure for Bio Medical Waste Management
ANNEXURE: 4 BIO MEDICAL WASTE RECORD (Sample only. Areas to be defined by respective facility). BIOMEDICAL WASTE REGISTER TO BE RETAINED FOR 5 YEARS DATE:
SUPERVISOR NAME: SHARP CONTAINER
AREA wise Quantity
RED
YELLOW
YELLOW CYTOTOXIC BLUE
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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Bio Medical Waste Management
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 Generation, segregation Collection, Storage packaging Reception Transportation
Please tick
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Bio Medical Waste Management
Activity Treatment or processing or conversion Recycling Disposal or destruction use offering for sale, transfer Any other form of handling
Please tick
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 This document contains proprietary information of FORTIS HEALTHCARE LTD For internal circulation only
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P age 5 9 of 80
Standard Operating Procedure for Bio Medical Waste Management
(vii) (viii)
Area or distance covered by CBMWTF:______________ (pl. attach map a map with GPS locations of CBMWTF and area of coverage) Quantity of Biomedical waste handled, treated or disposed:
Category
Type of Waste
(1) Yellow
(2)
Quantity Generated or Collected, kg/day (3)
Method of Treatment and Disposal (Refer Schedule-I) (4)
(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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FORTIS HEALTHCARE LIMITED Standard Operating Procedure for
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Bio Medical Waste Management
(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 documents):
plan
of common bio-medical waste treatment facility (CBWTF)(attach
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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Bio Medical Waste Management
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 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
Please tick
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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P age 6 2 of 80
Bio Medical Waste Management
Type of Waste Category Yellow Red White (Translucent) Blue
Quantity permitted for Handling
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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P age 6 3 of 80
Bio Medical Waste Management
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)
: Authorisation No.: ……………………………………………… ……valid up to ………
Status of Authorisation under the Bio-Medical Waste (Management and Handling) Rules
(xi) Status of Consents under Water Act and Air Act
: Valid up to:
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Bio Medical Waste Management
S.No. Particulars 2.
Type of Health Care Facility (i) Bedded Hospital
3.
: 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
:
Details of CBMWTF
:
(i)
4.
:
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
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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P age 6 5 of 80
Standard Operating Procedure for Bio Medical Waste Management
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 trea tment equipment
No. of uni ts
Ca pa c i ty Kg/da y
Qua ntity trea ted or di s posed i n kg per a nnum
Inci nerators Pl a sma Pyrolysis Autocl aves Mi crowa ve Hydrocl ave Shredder Needle tip cutter or des troyer Sha rps enca psulation or concrete pit Deep burial pits: Chemi cal di s infection: Any other trea tment equipment:
(iii)Quantity of recyclable wastes 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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P age 6 6 of 80
Bio Medical Waste Management
S.No. Particulars (vi)
Name of the Common BioMedical 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)
8.
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)
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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P age 6 7 of 80
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S.No. Particulars (iv) 9.
Any Fatality occurred, details
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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Bio Medical Waste Management
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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P age 6 9 of 80
Standard Operating Procedure for Bio Medical Waste Management
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. 1.
2.
Audit Criteria for Weekly/Monthly Audit
Yes/No
Comments
Waste segregation information is prominently displayed near or on the waste bins Staff (due for training) have attended a training session on correct & safe disposal of clinical waste
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P age 7 0 of 80
Bio Medical Waste Management
S. No. 3.
Audit Criteria for Weekly/Monthly Audit
Yes/No
Comments
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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Bio Medical Waste Management
S. No. 17
Audit Criteria for Weekly/Monthly Audit
Comments
Waste bags are removed from clinical areas daily
18
There is no emptying of clinical waste from one bag to another
19
Waste bags are not more than 3 /4 th full
20
Bags carrying waste are sealed/tied securely during transportation
21
Bags are labelled with information regarding point of generation
22
Bags carrying soiled linen is labelled as ‘Bio-hazard’
23
Staff wear industrial gloves during transport of waste
24
A separate closed trolley is used for waste transportation
25
The utility lift is used by the staff during waste transportation (if available)
26
Is the dedicated area (Central Storage Area) for the safe storage of biomedical waste (inside compound) locked & inaccessible to animals & public
27
Is the dedicated area (Central Storage Area) a safe, ventilated and secured location for storage of segregated biomedical waste in coloured bags or containers in the manner as specified in Schedule I, to ensure that there shall be no secondary handling, pilferage of recyclables or inadvertent scattering or spillage by animals. Is the bio-medical waste from such place or premises directly transported in the manner as prescribed in
28
Yes/No
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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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Bio Medical Waste Management
S. No. 44
Audit Criteria for Weekly/Monthly Audit
Yes/No
Comments
Has Immunization been done for all Health care Workers due for the same during the previous month
45
In case of a major accident has the same been reported along with the remedial actions within 24 hrs to the appropriate authority
46
If applicable within the last month has the Annual Report been submitted
47
If applicable within the last month has the application for renewal of License been submitted
48
In case of any change in the bio-medical waste generation, handling, treatment and disposal for which authorisation was earlier granted, has the intimation been sent to the prescribed authority about the change or variation in the activity and shall submit a fresh application in Form II for modification of the conditions of authorisation.
Auditor’s Name and Signature: Ward/Area audited: Date: Infection Control Officer
Med Supdt.
MSOG/BMW-SACL/20160701/1.0
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Standard Operating Procedure for Bio Medical Waste Management
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
(1)
(2)
(3)
(4)
(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 nonchlorinated plastic bags
Yellow
Yes/No
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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FORTIS HEALTHCARE LIMITED Standard Operating Procedure for
P age 7 6 of 80
Bio Medical Waste Management
Category
Type of Waste
Type of Bag or Container to be Used
Treatment and Disposal options
(1)
(2)
(3)
(4)
Yes/No
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.
(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.
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. Yellow coloured nonchlorinated 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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FORTIS HEALTHCARE LIMITED Standard Operating Procedure for
P age 7 7 of 80
Bio Medical Waste Management
Category
Type of Waste
Type of Bag or Container to be Used
Treatment and Disposal options
(1)
(2)
(3)
(4)
Yes/No
>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 nonchlorinated 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 pretreated before mixing with other wastewater. The combined discharge shall conform to the discharge norms given in ScheduleIII.
(g) Discarded linen, mattresses, beddings contaminated with blood or body fluid.
Nonchlorinated yellow plastic bags or suitable packing
Non- chlorinated chemical disinfection followed by incineration or Plazma Pyrolysis or
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FORTIS HEALTHCARE LIMITED Standard Operating Procedure for
P age 7 8 of 80
Bio Medical Waste Management
Category
Type of Waste
Type of Bag or Container to be Used
Treatment and Disposal options
(1)
(2)
(3)
(4)
material
Yes/No
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.
Red
(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.
Contaminated Waste (Recyclable)
Red coloured nonchlorinated 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
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.
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FORTIS HEALTHCARE LIMITED Standard Operating Procedure for
P age 7 9 of 80
Bio Medical Waste Management
Category
Type of Waste
Type of Bag or Container to be Used
Treatment and Disposal options
(1)
(2)
(3)
(4)
Yes/No
registered or authorized recyclers or for energy recovery or plastics to diesel or fuel oil or for road making, whichever is possible.
White Waste sharps including (Translucent) 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
Blue
(a) Glassware: Broken or discarded and contaminated glass including medicine vials
Puncture proof, Leak proof, tamper proof containers
Cardboard boxes with blue coloured
Plastic waste should not be sent to landfill sites. 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. Disinfection (by soaking the washed glass waste after cleaning with
This document contains proprietary information of FORTIS HEALTHCARE LTD For internal circulation only
FORTIS HEALTHCARE LIMITED
P age 8 0 of 80
Standard Operating Procedure for Bio Medical Waste Management
Category
Type of Waste
Type of Bag or Container to be Used
Treatment and Disposal options
(1)
(2)
(3)
(4)
and ampoules except those contaminated with cytotoxic wastes. (b) Metallic Body Implants
marking Cardboard boxes with blue coloured marking
Yes/No
detergent and Sodium Hypochlorite treatment) or through autoclaving or microwaving or hydroclaving and then sent for recycling.
Observations:
Auditor’s Name and Signature: Designation: Date: Infection Control Officer Med Supdt. (In case of improper waste treatment &/or disposal by outsourced vendor, please send relevant information to the State Pollution Control Board) MSOG/BMWTT-ACL/20160701/1.0
This document contains proprietary information of FORTIS HEALTHCARE LTD For internal circulation only
