August 24, 2005
JOINT DENR – DOH
ADMINISTRATIVE ORDER No. 2 series 2005
POLICIES AND GUIDELINES ON EFFECTIVE AND PROPER
HANDLING, COLLECTION, TRANSPORT, TREATMENT, STORAGE AND DISPOSAL OF HEALTH CARE
WASTES
I. RATIONALE
The Department of
Environment and Natural Resources (DENR) and the Department of Health (DOH)
hereby jointly provide the following guidelines on the management of health
care wastes pursuant to, among others, the following laws, rules and
regulations:
·
Clean Air Act of 1999 (Republic Act 8749)
·
Toxic Substances, Hazardous Waste, and Nuclear Waste
Control Act of 1990 (Republic Act 6969)
·
Ecological Solid Waste Management Act of 2000
(Republic Act 9003)
·
Refuse Disposal of the Sanitation Code of the
Philippines (Chapter XVIII, Implementing Rules and Regulations, Presidential
Decree 856)
·
Clean Water Act of 2004 (Republic Act 9275)
·
Environmental Impact Statement (EIS) System
(Presidential Decree 1586)
·
Hospital Licensure Act (Republic Act 4226)
II. OBJECTIVES
A. To provide guidelines to generators, transporters
and owners or operators of treatment, storage, disposal (TSD) facilities of health care waste on the proper
handling, collection, transport, treatment, storage and disposal thereof;
B. To clarify the jurisdiction, authority and
responsibilities of the DENR and DOH with regard to health care waste
management; and
C. To harmonize efforts of the DENR and DOH on proper
health care waste management.
III. SCOPE AND
COVERAGE
These policies and
guidelines shall apply to health care waste generators, transporters and owners
or operators of TSD and final disposal facilities
IV. DEFINITION OF
TERMS
A. Health Care Wastes – include all wastes generated as
a result of the following:
1. Diagnosis, treatment, management and immunization of
humans or animals;
2. Research pertaining to the above activities;
3. Producing or testing of biological products; and
4. Waste originating from minor or scattered sources
(i.e. dental clinics, alternative medicine clinics, etc.)
The categories of health
care wastes are enumerated in Annex A
B. Health Care Waste Generators – include health
facilities, institutions, business establishments and other similar health care
services with activities or work process that generate health care waste.
1. Hospitals (primary care, secondary care and tertiary
care)
2. Infirmaries
3. Birthing homes
4. Clinics
a.
Medical
b.
Ambulatory
c.
Dialysis
d.
Health care centers and dispensaries
e.
Surgical
f. Alternative Medicine
g.
Dental
h.
Veterinary
5. Laboratories and Research Centers
a. Medical and biomedical laboratories
b. Medical research centers
c. Blood banks and blood collection services
d. Dental prosthetic laboratories
e. Nuclear medicine laboratories
f. Biotechnology
laboratories
g. Animal research and testing
h. Drug testing laboratories
6. Drug Manufacturers
7. Institutions
a. Drug rehabilitation center
b. Training centers for embalmers
c. Medical Technology intern training centers
d. Schools of Radiologic Technology
e. Medical schools
f. Nursing homes
g. Dental schools
8. Mortuary and autopsy centers
C. Health care Waste Transporter – a person licensed by
the DENR Environmental Management Bureau to convey health care waste through
air, water or land.
D. Treatment, Storage and Disposal (TSD) Facilities –
facilities where hazardous wastes are stored, treated, recycles, reprocessed
and/or disposed of, as prescribed under DENR A.O. No. 2004 – 36, Chapter 6 – 2
(Categories of TSD Facilities).
V. RESPONSIBILITIES
OF IMPLEMENTING & COOPERATING AGENCIES
This Joint Administrative
Order shall be implemented by the DENR through the Environmental Management
Bureau (EMB) and its Regional Offices, the National Solid Waste Management
Commission (NSWMC), and by the DOH through its Centers for Health Development (CHD),
Bureau of Health Facilities and Services (BHFS), Bureau of Health Devices and
Technology (BHDT), Environmental and
Occupational Health Office (EOHO) of the National Center for Disease Prevention
and Control (NCDPC), the National Center for Health Facility Development
(NCHFD) and the National Reference Laboratory (NRL) East Avenue Medical Center,
Quezon City.
A. The DENR – EMB shall:
1. Be the primary government agency responsible for
implementing pertinent rules and regulations on the management of health care
waste in the Philippines, particularly concerning the issuance of necessary
permits and clearances for the Transport, Treatment, Storage and Disposal of
such wastes as governed by R.A. 9669, R.A. 8749, R.A. 9003 and PD 1586;
2. Formulate policies, standards and guidelines on the
transport, treatment, storage and disposal of health care wastes.
3. Oversee compliance by generators, transporters, TSD
facility operators, and/or final disposal facility operators with the proper
transport, treatment, storage and disposal of health care wastes;
4. Conduct regular sampling and monitoring of
wastewater in health care and TSD facilities to determine compliance with the
provisions of R.A. 9725;
5. Require TSD facility operators and on–site treaters
to present to the DENR copies of the results of microbiological tests on the
health care waste treated using autoclave, microwave, hydroclave and other
disinfection facilities prior to the renewal of their permits under R.A. 6969;
6. Provide technical assistance and support to the
advocacy programs on health care waste management; and
7. Notify DOH on cases of non–compliance or notice of
violation issued to health care facilities, institutions and establishments
licensed by the DOH.
B. The DOH shall:
1. Regulate all hospitals and other health facilities
through licensure and accreditation under the Hospital Licensure Act (Republic
Act No. 4226);
2. Formulate policies, standards, guidelines, systems
and procedures on the management of health care waste;
3. Develop training programs and corresponding modules
on health care waste management;
4. Provide technical assistance in the preparation of
health care waste management plan as a requirement for licensing or the renewal
thereof;
5. Provide technical assistance to ensure an effective
and efficient implementation of health care waste management program;
6. Require all health care waste TSD facility operators
and health care waste generators with on–site treatment facilities to use DOH –
BHDT registered equipment or devices used for the treatment of health care
wastes;
7. Conduct regular performance evaluation of
equipment/devices used for the treatment of health care wastes by the DOH –
BHDT;
8. Monitor the microbiological test of treated wastes
to ensure compliance with DOH standards;
9. Evaluate DOH hospitals compliance with proper health
care waste management program;
10. Issue Department Circulars to ensure that all
environmental requirements are complied with; and
11.
Notify DENR on actions taken on cases of
non–compliance or notice of violation issued to health care facilities,
institutions and business establishments.
C. The DOH – Centers for Health Development shall:
1. Advocate health care waste management (HCWM)
practices to the local Chief Executives, key leaders and other stakeholders;
2. Monitor health care waste management practices in
all hospitals and other health care facilities;
3. Provide technical assistance on health care waste
management (HCWM) through:
a. Training
b. Advisory on the preparation of HCWM plans as a
requirement for licensing or the renewal thereof.
c. Dissemination of policies, guidelines and
information
d. Monitoring and validation of the implementation of
HCWM
e. Develop, reproduce and disseminate HCWM IEC
materials. Participation in any public hearings related to HCWM
f. Ensure compliance by health care waste generators
with all pertinent laws, rules and regulations on HCWM.
VI. GUIDELINES AND
PROCEDURES
A. ENVIRONMENTAL COMPLIANCE REQUIREMENTS
1. Documentary Requirements
a. Health Care Waste Generators
Health care waste generators
are required, based on the existing laws, rules and regulations, to register
and secure the following permits:
(1) From the DENR –
Environmental Management Bureau:
(a) Environmental
Compliance Certificate (ECC) – for the establishment of hospitals, health care
facilities covered by the provisions of PD 1586 from the EMB Central Office or
its Regional Offices.
(b) Permit to Operate
(O/P) – for Air Pollution Source and Control Installation from the EMB Regional
Office.
(c) Discharge Permit
will be issued by the EMB Regional Office and the Laguna Lake Development
Authority (LLDA) based on R.A. 9275 or the Clean Water Act of 2004
(d) Hazardous Waste
Generator’s Registration in compliance with the implementing rules and
regulations of R.A. 6969 (DAO 29 series of 2004) from the EMB Regional Office.
(2) From the DOH –
Bureau of Health Facilities and Services
(a) Licenses for
hospitals, laboratories, dialysis clinics, birthing homes, infirmaries,
psychiatric hospitals, dental prosthetic laboratories, blood banks, ambulatory
clinics, and drug treatment and rehabilitation centers.
(b) Certificate of
Accreditation for Overseas Filipino Workers (OFW) medical clinics, surgical clinics,
drug testing laboratories, HIV testing laboratories, water testing
laboratories, medical technologist intern training centers and training centers
for embalmers.
b. Health care waste transporters
Health care waste
transporters are required, based on existing laws, rules and regulation to
undertake the following:
(1) Register with EMB
Central Office as healthcare waster transporter;
(2) Secure Transport
Permit from the DENR – EMB Regional office;
(3) Comply with the
DENR Manifest System; and
(4) Comply with other
requirements specified in the implementing rules and regulation of R.A. 6969
c. TSD facilities
Owners or operators of TSD
facilities are required based on existing rules and regulations to secure the
following permits and clearances from DENR – EMB and DOH:
(1) Environmental
Compliance Certificate (ECC) for the Sanitary Landfill (SLF) and TSD Facility
from the EMB Central Office or Regional Office.
(2) Notice to Proceed
from controlled dump facility to be used as repository of health care waste
from the EMB Regional office
(3) Registration as
TSD facility based on the implementing rules and regulation of R.A. 6969 from
EMB Central Office.
(4) Technology Approval
for non–burn technologies from the EMB Central Office prior to the issuance of
Permit to Operate
(5) Permit to Operate
(O/P) Air Pollution Source and Control Installation from EMB Regional Office
(6) Discharge Permit
from the EMB Regional Office or LLDA
(7) Certificate of
Product Registration for equipment or devices used for treating health care
wastes from the DOH – BHDT
(8) Certificate of
Technical Evaluation for equipment or devices used for treating health care
wastes from the NRL – EAMC
B. PROCEDURES FOR SECURING PERMITS AND LICENSES
Permits and licenses shall
be secured following the established procedures of the DENR and DOH.
C. SPECIFIC CRITERIA, STANDARDS, AND GUIDELINES
1. Handling, collection, storage and transport of
health care wastes shall be in accordance with the provision of R.A. 8749, R.A.
9669 and R.A. 9003 and the DOH Health Care Waste Management Manual (Chapter 5)
2. Treatment
(a) Facilities shall consider technologies and processes
used in health care waste treatment such as (1) thermal, (2) chemical, (3)
irradiation, (4) biological processes, (5) encapsulation, and (6) inertization,
as outlines in the DOH Health Care Waste Management Manual and subject to
compliance with the provisions of R.A. 8749, R.A. 6969 and R.A. 9003.
(b) Autoclave, microwave, and hydroclave facilities shall
use microbiological test to determine the treatment efficiency of the units,
the results of the microbiological test shall be recorded and reported to DENR
under R.A. 6969 and R.A. 9003.
(c) Health care waste generators and TSD facilities
shall observe a level of microbial inactivation of 6log10 reduction
or greater than the most resistant microorganism of concern in a given process.
(d) Treated wastes and inert residues from TSD
facilities must be disposed in controlled disposal or sanitary landfill facilities
duly licensed by the DENR to handle the same.
(e) Inertization is a suitable treatment for
pharmaceutical wastes while encapsulation and other immobilization techniques
are treatment methods considered for sharps, chemicals and pharmaceutical
wastes and should therefore be placed in final disposal facilities indicated
under the subsequent Section.
3. Final waste Disposal Systems and Facilities
The use of proceeding
disposal facilities should only be limited to health care wastes which have
undergone the necessary treatment provided under the prescribed standards
stipulated in the DOH Health Care Waste Management Manual.
(a) Controlled Dump Facility
(1) A Controlled Dump
Facility (CDF) is an interim disposal facility for municipal solid waste or
those that are considered as non– hazardous and non–toxic substances. In the
absence of a sanitary landfill, a controlled dumpsite could accept health care waster
after the indicative treatment thereof.
(2) In addition to
the operational guidelines stipulated under Section 2 of Rule XIII of the
implementing rules and regulations of R.A. 9003 or as indicated in the
conditions stipulated in the issuance of the NTP, a CDF that is commissioned to
accept health care waste should also be operated in accordance with the following
specific requirements:
§ Identify a
particular cell within the facility to serve as a site for the disposal of
treated health care waste. The capacity of the allotted cell/cell(s) should be
measured that can be accommodated in the facility.
§ Adequate signage
should be placed in the health care waste deposition area.
§ The cell should
be lined with a material of low permeability, such as clay or a geo–membrane such
as a high–density polyethylene (HDPE) plastic liner to contain the leachate and
prevent contamination of groundwater sources within the area.
§ Ensure that
adequate soil cover is placed on the cells right after each waste spreading.
§ Basic record
keeping of the incoming wastes indicating the time of receipt, volume or
weight, source identification (i.e., name of generator or source),
certification of treatment (or any similar form indicating that the waste have undergone the necessary treatment)
and the general condition of the waste to be disposed.
(b) Sanitary Landfill Facility
(1) A Sanitary
Landfill Facility (SLF) is a disposal site designed, constructed, operated and
maintained in a manner that exerts engineering control over significant
potential environmental impacts arising from the development and operation
thereof.
(2) The required
dedicated cells for treated health care wastes should be built or developed
prior to its operation to prevent the mixing thereof with municipal solid
wastes and other wastes.
(3) Aside from the
ECC, which is required for such facility, the construction and development of
an SLF must conform to R.A. 9003 and its implementing rules and regulations,
particularly section 1 and 2, rule XIV.
(4) Existing sanitary
landfill with approved ECC for the disposal of municipal solid waste must
secure an amendment of their ECC before accepting health care waste for
disposal thereat.
(c) Safe Burial on Healthcare Facility Premises
(1) Safe burial
within the premises of healthcare facilities shall be allowed in remote
locations and rural areas where no STD facilities are available. In such
activity of safe burial, the health care facility must ensure that the load or
capacity of the on–site burial pit is not exceeded.
(2) Chemical
treatment or disinfection is required prior to safe burial on hospital
premises.
(3) The standards for
safe burial within the healthcare facility premises shall follow the guidelines
specified in the DOH Health Care Waste Management Manual.
(4) Relative to the
guidelines provided by DOH, the operation of safe burial should be in
accordance with the minimum requirements for landfill.
(d) Sharps and Syringes Disposal Through Concrete Vault
(1) Disposal using
concrete vault shall be allowed only as an alternative means of disposal of
used sharps and syringes.
(2) Concrete vault
shall be marked with proper signage:
CAUTION:
HAZARDOUS WASTE OR SHARPS DISPOSAL AREA – UNAUTHORIZED PERSONS KEEP OUT
(3) Concrete vault
should be watertight and must be constructed at least 1.5 meters above the
groundwater level.
(4) The procedures
for the safe burial of sharps and syringes through concrete vault shall follow
the guidelines in the DOH Health Care Waste Management Manual.
4. Wastewater Treatment Facility
Healthcare facilities shall
have their own Wastewater Treatment Facilities (WTF) or maybe connected into a
sewage treatment plant. However, facilities with laboratories shall be required
to pre – treat their wastewater prior to discharge into a sewage treatment
plant.
VII. REPEALING CLAUSE
All other issuances whose provisions
of DENR and DOH Administrative Order, Memorandum Circulars or other issuances
inconsistent herewith are hereby repealed or modified accordingly.
VIII. PENALTY CLAUSE
Failure to comply with the
policies/guidelines shall be subject to the penalty provisions of the
applicable laws stated herein.
IX. EFFECTIVITY
This order shall take effect
immediately.
MICHAEL T. DEFENSOR
FRANCISCO T. DUQUE III, MD, MSc
FRANCISCO T. DUQUE III, MD, MSc
ANNEX A
CATEGORIES OF HEALTHCARE
WASTE
1. General Waste – comparable to domestic
waste, this type of waste does not pose special handling problem or hazard to
human health or to the environment. It comes mostly from the administrative and
housekeeping functions of health care establishments and may also include waste
generated during maintenance of health care premises. General waste should be
dealt with the municipal waste disposal system.
2. Infectious Waste – this type of waste is
suspected to contain pathogens (bacteria, viruses, parasites, or fungi) in sufficient
concentration or quantity to cause disease in susceptible hosts. This includes:
a. Cultures and stocks of infectious agents from
laboratory work;
b. Waste from surgery and autopsies on patients with
infectious diseases (e.g. tissues, materials or equipment that have been in
contact with blood or other body fluids);
c. Waste from infected patients in isolation wards
(e.g. excreta, dressings from infected or surgical wounds, clothes heavily
soiled with human blood or other body fluids);
d. Waste that has been in contact with infected
patients undergoing hemodialysis (e.g. dialysis equipment such as tubing and
filters, disposable towels, gowns, aprons, gloves and laboratory coats);
e. Infected animals from laboratories; and
f. Any other instruments or materials that have been in
contact with infected person or animals.
3. Pathological Waste – pathological waste
consists of tissues, organs, body parts, human fetus and animal carcasses,
blood and body fluids. Within this category, recognizable human or animal body
parts are also called anatomical waste. This category should be considered as a
subcategory of infectious waste, even though it may also include healthy body
parts.
4. Sharps – include needles, syringes, scalpels, saws,
blades, broken glass, infusion sets, knives, nails and other items that can
cause a cut or puncture wounds. Whether or not they are infected, such items
are usually considered as highly hazardous health care waste.
5. Pharmaceutical waste – includes expired, unused,
split and contaminated pharmaceutical products, drugs, vaccines and sera that
are no longer required and need to be disposed of appropriately. This category
also includes discarded items used in handling of pharmaceuticals such bottles
or boxes with residues, gloves, masks, connecting tubing and drug vials.
6. Genotoxic Waste – genotoxic waste may
include certain cytostatic drugs, vomit, urine, or feces from patients treated
with cytostatic drugs, chemicals and radioactive materials. This type of waste
is highly hazardous and may have mutagenic, teratogenic or carcinogenic
properties.
Harmful cytostatic drugs can
be categorized as follows:
a. Alkylating agents: cause alkylation of DNA
nucleotides, which leads to cross–linking and miscoding of the genetic stock;
b. Anti–metabolites: inhibit the biosynthesis of
nucleic acids in the cell; mitotic inhibitors: prevent cell replication
Cytotoxic wastes are generated
from several sources and include the following:
a. Contaminated materials from drug preparation and
administration, such as syringes, needles, gauges, vials, packaging; outdated
drugs, excess (left over) solutions, and drugs returned from the wards;
b. Urine, feces, and vomit from patients which may
contain potentially hazardous amounts of the administered cytotoxic drugs or of
their metabolites and which should be considered genotoxic for at least 48 hours
and sometimes up to 1 week after drug administration.
7. Chemical waste – chemical waste consists
of discarded solid, liquid and gaseous chemicals, for example from diagnostic
and experimental work and from cleaning, housekeeping and disinfecting
procedures. Chemical waste from health care may be hazardous or non–hazardous.
a. Chemical waste is considered hazardous if it has at
least one of the following properties:
(1)
Toxic
(2)
Corrosive
(3)
Flammable
(4)
Reactive (explosive, water – reactive, shock
sensitive)
(5)
Genotoxic (e.g. cytostatic drugs)
b. Non–hazardous chemical waste consists of chemicals
with none of the above properties, such as sugars, amino acids and certain
organic and inorganic salts.
8. Waste with high content of heavy metals – wastes with
high heavy metal content represent a subcategory of hazardous chemical waste,
and are usually highly toxic. Mercury wastes are typically generated by
spillage from broken clinical equipment (thermometers, blood pressure gauges,
etc). Whenever possible, spilled drops of mercury should be recovered. Residues
from dentistry have high mercury content. Cadmium waste comes mainly from
discarded batteries. Certain “reinforced wood panels” containing lead is still
being used in radiation proofing of X – ray and diagnostic departments. A
number of drugs contain arsenic but these are treated here as pharmaceutical
waste.
9. Pressurized containers – many types of gas are
used in health care and care often stored in pressurized cylinders, cartridges,
and aerosol cans. Many of these, once empty or of no further use (although they
may still contain residues), are reusable, but certain types notably aerosol
cans, must be disposed of. Whether inert or potentially harmful; gases in
pressurized containers should always be handled with care; containers may
explode if incinerate or accidentally punctured.
10. Radioactive waste – includes disused sealed
radiation sources, liquid and gaseous materials contaminated with
radioactivity, excreta of patients who underwent radio–nuclide diagnostic and
therapeutic applications, paper cups, straws, needles and syringes, test tubes
and tap water washings of such paraphernalia. It is produced as a result of
procedures such as in vitro analysis of body tissues and fluids, in vivo organ
imaging, tumor localization and treatment, and various clinical studies
involving the use of radioisotopes. Radioactive health care wastes generally
contain radionuclides with short half–lives, which lose their activity in a
shorter time. However, certain radionuclides like C–14 contaminated wastes have
much longer half – life, more than a thousand years, which need to be specially
managed in a centralized treatment facility for radioactive wastes. The same is
required for the management of disused sealed radiation sources used for cancer
treatment.
ANNEX C
GUIDELINES FOR SAFE BURIAL
WITHIN HOSPITAL PREMISES
Safe burial within the hospital premises shall be in accordance with
the guidelines specified in the DOH Health Care Waste Management Manual as
follows:
1. Access to the disposal site should be restricted to
authorized personnel only.
2. The burial site should be lined with a material of
low permeability, such as clay or geo–membrane such as high–density
polyethylene (HDPE) plastic liner at the bottom of the pit to prevent
contaminating groundwater and avoid pollution.
3. Only hazardous health care waste should be buried.
If general health care waste were also buried on the premises, available space
would be quickly filled up.
4. Large quantities (>1 kg) of
chemical/pharmaceutical wastes should not be buried.
5. The burial site should be managed as landfill, with
each layer of waste covered with a layer of earth to prevent odor, as well as
to prevent proliferation of rodents and insects.
6. Burial site should be located in flood prone areas.
7. Hospital ground should be secured. (e.g. fenced with
warning signs).
8. The location of waste burial pit should be downhill
or down–gradient from any nearby wells and about 50 meters away from any
water body such as rivers or lakes to prevent contaminating sources of water.
9. Health care facilities should keep a permanent
record of the size and location of their on–site burial pits to prevent
construction workers, builders, and others from digging in those areas in the
future.
10. The safe burial of waste depends critically on
rational operational practices. The bottom of the pit should be at least 1.50
meters higher than the ground water level.
11.
It should be noted that safe on–site burial is practicable
only for relatively limited period, say 1 to 2 years, and for relatively small
quantities of waste, say up to 5 to 10 tons in total. Where these conditions
are exceeded, a longer – term solution will be needed.
ANNEX D
PROCEDURES FOR THE SAFE
BURIAL OF SHARPS AND SYRINGES THROUGH CONCRETE VAULT
The procedures for the safe burial of sharps and syringes through
concrete vault shall be in accordance with the guidelines in the DOH Health
Care Waste Management Manual as follows:
1. Dig a pit (minimum size of 1m x 1m x 1.8m depth),
enough to accommodate sharps and syringes for an estimated period of time
without reaching the groundwater level. The site must be isolated and at least
152 meters away from the groundwater supply sources and dwelling units.
2. Construct concrete walls and slabs of the pit.
Provide slab with opening or manhole for easy deposition of collected sharps
and syringes. The manhole should be extended a few centimeters above the soil
surface to overcome infiltration of surface water.
3. Deposit the collected safety boxes filled with used
sharps and needles inside the concrete vault.
4. Install a security fence around the site.
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