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BioMedical Waste PDF
BioMedical Waste PDF
80
Standard Operating Procedure for
STANDARD OPERATING
PROCEDURE
SOP BMW-P-2016-1.1
Number:
Version 1.1 Effective 1st July Supersedes BMW-P- Next 31st
Number: Date: 2016 Version: 2016-1.0 Review March
Date: 2017
Prepared Dr Ravneet Reviewe Dr Approved Dr Bishnu Panigrahi
By: Kaur, d By: Akash By:
Dr Anita Sud
Arora,
Dr Anita
Sharma
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
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 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.
GDA/Housekeeping - as required
V. Definitions
Sl. Term Definition
No.
2 Bio-medical "bio-medical waste" means any waste, which is generated during the
Waste diagnosis, treatment or immunisation of human beings or animals or
research activities pertaining thereto or in the production or testing of
biological or in health camps, including the categories mentioned in
Schedule I appended to these rules.
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.
VII. Flowchart – NA
VIII. Process
3. Segregation of Waste
________________________________________________________________
(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;
(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;
(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;
(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).
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.
#
Category Type of Waste Type of Bag Treatment and Interpretation
or Disposal options
Container
to be Used
#
Category Type of Waste Type of Bag Treatment and Interpretation
or Disposal options
Container
to be Used
#
Category Type of Waste Type of Bag Treatment and Interpretation
or Disposal options
Container
to be Used
#
Category Type of Waste Type of Bag Treatment and Interpretation
or Disposal options
Container
to be Used
#
Category Type of Waste Type of Bag Treatment and Interpretation
or Disposal options
Container
to be Used
#
Category Type of Waste Type of Bag Treatment and Interpretation
or Disposal options
Container
to be Used
facility.
White Waste sharps including Puncture Autoclaving or Dry No Pre-
(Translucent) Metals: Needles, syringes proof, Leak Heat Sterilization treatment,
with fixed needles, needles proof, followed by shredding shredding/
from needle tip cutter or tamper proof or mutilation or mutilation
burner, scalpels, blades, or containers encapsulation in metal required to be
any other contaminated container or cement done by the
sharp object that may cause concrete; combination hospital if
puncture and cuts. This of shredding cum handing over to
includes both used, autoclaving; and sent the operator of
discarded and contaminated for final disposal to common Bio-
metal sharps iron foundries (having medical Waste
consent to operate from treatment
the State Pollution facility.
Control Boards or
Pollution Control
Committees) or
sanitary landfill or
designated concrete
waste sharp pit.
*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.
7. Dead Foetus below the viability period (as per the Medical Termination of Pregnancy Act
1971, amended from time to time) can be considered as human anatomical waste. Such
waste should be handed over to the operator of common bio-medical waste treatment and
disposal facility in yellow bag with a copy of the official Medical Termination of
Pregnancy certificate from the Obstetrician or the Medical Superintendent of hospital or
healthcare establishment.
#
Interpretation – This shall not be applicable, if on MTP there is no solid foetus mass.
8. Cytotoxic drug vials shall not be handed over to unauthorised person under any
circumstances. These shall be sent back to the manufactures for necessary disposal at a
single point. As a second option, these may be sent for incineration at common bio-
medical waste treatment and disposal facility or TSDFs or plasma pyrolysis at
temperature >1200 0 C.
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.
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.
________________________________________________________________
Job Responsibility: Doctors, Nurses, Technicians, GDA, all employees handling BMW.
Description
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)
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.
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.
________________________________________________________________
Objective: Waste removal & transportation to minimize the risk of any infection.
Description:
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
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.
________________________________________________________________
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.
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.
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.
13. On-site pre-treatment of laboratory waste, microbiological waste, blood samples, blood
bags should be disinfected or sterilized as per the Guidelines of World Health
Organisation or National AIDS Control Organisation and then given to the common bio-
medical waste treatment and disposal facility.
14. Syringes should be either mutilated or needles should be cut and or stored in tamper
proof, leak proof and puncture proof containers for sharps storage. Wherever the occupier
is not linked to a disposal facility it shall be the responsibility of the occupier to sterilize
and dispose in the manner prescribed.
#
Interpretation – No mutilation of syringes or cutting of needles required to be done by the
hospital if handing over to the operator of common Bio-medical Waste treatment facility
________________________________________________________________
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.
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.
________________________________________________________________
Description:
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
#
Interpretation – Only Point No. (vi) is to be filled by the (Hospital) Occupier (if waste
is being handed over to the operator of common Bio-medical Waste treatment facility)
& rest of the points are for the operator of common Bio-medical Waste treatment
facility.
v. Minutes of Meeting of the Bio-Medical Waste Management Committee (Sub-
committee of Infection Control Committee) held during the reporting period.
vi. Records of all Trainings Conducted, including
Number of Trainings Conducted on BMW Management
Number of Personnel Trained
Number of Personnel Trained at the time of induction
Number of Personnel not undergone any training so far
Whether any standard manual for training is available
vii. Report of all accidents (major and minor) and the remedial actions taken,
including Nil Report in Form 1 (Annexure 8) including
Number of Accidents occurred during the year
Number of persons affected
Remedial Actions taken with details (if any)
Details of any Fatality occurred
viii. Liquid Waste generated and treatment methods in place including
Number of times in a year when the standards were not met
ix. Whether disinfection method or sterilization meeting the log 4 standards
including
Number of times in a year when the standards were not met
3. Accident Reporting
b. Information regarding all other accidents and remedial steps taken shall be provided
in the annual report (including Nil report).
4. Maintaining of Records
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.
5. Other Requirements
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.
________________________________________________________________
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
________________________________________________________________
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.
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.
ANNEXURE: 1
ANNEXURE: 2
ANNEXURE: 3
A. Operating Standards
(1) Combustion efficiency (CE) shall be at least 99.00%.
(2) The Combustion efficiency is computed as follows:
%CO2
CE = --------------------- X 100
%CO2 + % CO
B. Emission Standards
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.
(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.
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.
(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.
(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 .
(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,
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.
(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.
(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.
ANNEXURE: 4
BIO MEDICAL WASTE RECORD (Sample only. Areas to be defined by respective facility).
4th floor
3rd floor
O.T. Area
2nd floor
1st floor
Ground floor
Basement
TOTAL
SUPERVISOR
SIGN: Exe. Sign
ANNEXURE: 5
(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:
(ii) Name of the health care facility (HCF) or common bio-medical waste treatment
facility (CBWTF) :
(v) Email:
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
(ii) Details of treatment equipment (please give details such as the number, type &
capacity of each unit)
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
ANNEXURE 6
(Authorisation for operating a facility for generation, collection, reception, treatment, storage,
transport and disposal of biomedical wastes)
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.
ANNEXURE: 7
FORM IV
ANNUAL REPORT
[To be submitted to the prescribed authority on or before 30th June every year for the period
from January to December of the preceding year, by the occupier of health care facility (HCF) or
common bio-medical waste treatment facility (CBWTF)]
S.No. Particulars
1. Particulars of the Occupier :
(i) Name of the authorised person :
(occupier or operator of
facility)
(ii) Name of HCF or CBMWTF :
(iii) Address for Correspondence :
(iv) Address of Facility :
(v) Tel. No, Fax. No :
(vi) E-mail ID :
(vii) URL of Website :
(viii) GPS coordinates of HCF or :
CBMWTF
(ix) Ownership of HCF or : (State Government or Private or Semi Govt.
CBMWTF or any other)
(x) Status of Authorisation under : Authorisation No.:
the Bio-Medical Waste ………………………………………………
(Management and Handling) ……valid up to ………
Rules
(xi) Status of Consents under : Valid up to:
Water Act and Air Act
S.No. Particulars
2. Type of Health Care Facility :
(i) Bedded Hospital : No. of beds (# Interpretation – Census or Registered Beds)
(ii) Non-bedded hospital (Clinic or :
Blood Bank or Clinical
Laboratory or Research Institute
or Veterinary Hospital or any
other)
(iii) License number and its date of :
expiry
3. Details of CBMWTF :
(i) Number healthcare facilities :
covered by CBMWTF
(ii) No. of beds covered by :
CBMWTF
(iii) Installed treatment and : _______ Kg per day
disposal capacity of
CBMWTF:
(iv) Quantity of biomedical waste : _____ Kg/day
treated or disposed by
CBMWTF
4. Quantity of waste generated or : Yellow Category:
disposed in Kg per annum (on
Red Category:
monthly average basis)
White:
(# Interpretation – Month wise and Total
Annual Quantity) Blue Category :
General Solid waste:
5. Details of the Storage, treatment, transportation, processing and Disposal Facility
#
Interpretation – Only Point No. (vi) is to be filled by the (Hospital) Occupier (if waste is being
handed over to the operator of common Bio-medical Waste treatment facility) & rest of the
points are for the operator of common Bio-medical Waste treatment facility.
S.No. Particulars
(i) Details of the on-site storage Size:
facility
Capacity:
Provision of on-site storage : (cold storage or
any other provision)
(ii) Disposal facilities Type of trea tment No. of Ca pa c Qua ntity
equipment uni ts i ty trea ted or
Kg/da di s posed i n
y kg per
a nnum
Inci nerators
Pl a sma Pyrolysis
Autocl aves
Mi crowa ve
Hydrocl ave
Shredder
Needle tip cutter
or des troyer
Sha rps
enca psulation or
concrete pit
Deep burial pits:
Chemi cal
di s infection:
Any other
trea tment
equipment:
(iii)Quantity of recyclable wastes Red Category (like plastic, glass etc.)
sold to authorized recyclers after
treatment in kg per annum.
(iv) No of vehicles used for collection
and transportation of biomedical
waste
(v) Details of incineration ash and Quantity Where
ETP sludge generated and generated disposed
Incineration
disposed during the treatment of
Ash
wastes in Kg per annum ETP Sludge
S.No. Particulars
(vi) Name of the Common Bio-
Medical Waste Treatment
Facility Operator through
which wastes are disposed of
(vii) List of member HCF not
handed over bio-medical waste
6. Do you have bio-medical waste
management committee? If yes,
attach minutes of the meetings held
during the reporting period
7. Details trainings conducted on BMW
(i) Number of trainings
conducted on BMW
Management.
(ii) number of personnel trained
(iii) number of personnel trained
at the time of induction
(iv) number of personnel not
undergone any training so far
(v) whether standard manual for
training is available?
(vi) any other information)
8. Details of the accident occurred
during the year
(i) Number of Accidents
occurred
(ii) Number of the persons
affected
(iii) Remedial Action taken
(Please attach details if any)
S.No. Particulars
(iv) Any Fatality occurred, details
9. Are you meeting the standards of air
Pollution from the incinerator? How
many times in last year could not met
the standards?
Details of Continuous online
emission monitoring systems
installed
10. Liquid waste generated and treatment
methods in place. How many times
you have not met the standards in a
year?
11. Is the disinfection method or
sterilization meeting the log 4
standards? How many times you have
not met the standards in a year?
12. Any other relevant information (Air Pollution Control Devices attached with
the Incinerator)
Certified that the above report is for the period from ……………………………………………
………………………………………………………………………………………………………
Place:
ANNEXURE: 8
FORM I
ACCIDENT REPORTING
Date....................... Signature..............................
Place...................... Designation.................................
ANNEXURE: 9
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.
After completion of audit, audit report to be submitted to Infection Control Officer with
copy to MS. Sheets must be retained for 5 years
The below mentioned points are to be only audited during the monthly audit covering the entire hospital
Ward/Area audited:
Date:
animal houses.
>12000C.
All other discarded
medicines shall be
either sent back to
manufacturer or
disposed by
incineration.
registered or
authorized recyclers
or for energy
recovery or plastics
to diesel or fuel oil
or for road making,
whichever is
possible.
Observations:
Designation:
Date: