The Clinical Laboratory ISSUES TO CONSIDER WHEN ESTABLISHING A

LABORATORY:
ENVIRONMENTAL ASSESSMENT
Clinical laboratories
• What are the customer needs?
• are healthcare facilities providing a wide
• Who is the competition?
range of laboratory procedures which aid
• 4 P’s of Marketing
the physicians in carrying out the diagnosis,
Product
treatment, and management of patients
Price
BASIC MANAGEMENT RESPONSIBILITIES Place
Promotion
• Right testing menu
OPERATION MANAGEMENT
• Equipments
• Quality assurance • Facilities
• Policy and procedures • Personnel
• Strategic planning • Adequate financial resources
• Benchmarking • Test cost analysis
• Productivity assessment
• Legislation / regulations CUSTOMER SEGMENTS/ SPECIFIC TARGETS
• Medico legal concerns
• Continuing education • Health care providers
• Staff meetings • Hospital laboratories, Physician office
laboratories (POL)
HUMAN RESOURCE MANAGEMENT • Insurance company
• Job description • Colleges, Universities and other schools
• Recruitment and staffing • Nursing homes, Home Health Agencies,
• Orientation Clinics
• Competency assessment • Researchers, Clinical trials, Pharmaceutical
• Personnel records companies
• Performance evaluation • Unique socio economic and ethnics
• Discipline and dismissal • Population shifts (rural, urban, suburban)

FINANCIAL MANAGEMENT
PROCESSES AND MARKETING
• Departmental budgets
• Billing • Develop a sales/marketing plan
Develop brochures
• Test cost analysis
Specimen collection manuals
• Fee schedule maintenance
Other customer related materials Website
MARKETING MANAGEMENT • Set goals
• Ensure infrastructures is adequate
• Customer service
• Support and maintain existing client
• Outreach marketing services
• Advertising • Place advertisements
• Website development
• Client education
APPLICATION OF PERMIT TO CONSTRUCT
1. Letter of application to the director of BHFS
2. Four(4) set of site development plans and floor
plans approved by architect and or engineer
3. SEC registration (for private laboratory) - if
partnership if sole prop. DTI registration only
APPLICATION FOR NEW LICENSE CLASSIFICATION OF LABORATORIES
1. A duly notarized application form “Petition to
Establish, Operate and Maintain a Clinical
BY FUNCTION:
Laboratory” shall be filed by the owner or his duly
authorized representative at the BHFS. • Clinical pathology:
includes Hematology, Clinical Chemistry,
PERMIT AND LICENSE FEES: Mycology, Microbiology, Parasitology,
1. A non refundable license fee shall be charged for Clinical microscopy, Immunology and
application for permit to construct to operate a Serology, Immunohematology,
government and private clinical laboratory Endocrinology, Toxicology and Therapeutic
2. A non refundable fee shall be charged for Drug Monitoring.
application for renewal of license to operate. • Anatomic Pathology:
3. All fees shall follow the current prescribed includes Surgical Pathology,
schedules of fees to the DOH. Immunohispathology, Cytology, Autopsy and
Forensic Pathology.

LABORATORY PHYSICAL DESIGN

CONSIDERATION:

• Identify space for offices, personal facilities,

storage, and conference/library.
• Review all floor plans, elevations for
appropriate usage, ensure space and
functions are related.
• Fume hoods, biological safety cabinets
must be located away from high traffic areas
and doorways
• Ensure proper temperature
• Base cabinets for laboratory counters
• Noise control, install ceilings
• Eyewash unit must be within 100 feet of
work areas.
• SUGGESTED STANDARD DIMENSIONS:
Laboratory counter width: 2 feet 6 inches
Lab. Counter to wall clearance: 4 feet Lab.
Counter to counter clearance: 7 feet Desk
Height : 30 inches
Keyboard drawer height: 25-27 inches
Human body standing: 4 square feet
Human body sitting: 6 square feet Desk
space: 3 square feet
CLASSIFICATION OF LABORATORIES
BY INSTITUTIONAL CHARACTER:

• Hospital-based laboratory – a laboratory

that operates within the hospital.
• Non-hospital based laboratory- operates
on its own.
BY SERVICE CAPABILITY

• PRIMARY
- Routine hematology (Hematocrit,
Hemoglobin, WBC count, Differential Count
and Qualitative Platelet Determination)
- Routine Urinalysis and Fecalysis
- Blood typing
• SECONDARY
- All primary laboratory tests
- Routine Clinical Chemistry (Glucose,
BUN, BUA, Creatinine, Blood Total
Cholesterol Concentration)
- Crossmatching
• TERTIARY
- All secondary laboratory testing
- Special Chemistry
- Special Hematology
- Immunology and Serology
- Microbiology
TECHNICAL STANDARDS AND MINIMUM
REQUIREMENTS:

STAFFING

• The clinical laboratory must be managed

by a licensed physician certified by the
Phil Board of Pathologist.
• A clinical laboratory shall have sufficient
number of registered medical
technologist proportional to the workload
 and shall be available at all times during
hours of laboratory operation.
• There shall be staff development and
appropriate continuing education
program available at all levels of
organization to upgrade knowledge
attitudes and skills of staffs.
PHYSICAL FACILITIES
• The clinical laboratory shall be well-
ventilated, adequately lighted, cleaned
and safe.
• The working space shall be sufficient to
accommodate its activities and allow
smooth and coordinated work flow.
• There shall be an adequate water
supply
• The working space for all categories of
clinical laboratories shall have at least
the ff. measurements:
Primary – 10 sq. m
Secondary- 20 sq. m
Tertiary- 60 sq. m (inc. separate
enclosed and adequately ventilated
room for Microbiology)
EQUIPMENT / INSTRUMENTS
• There shall be provisions for sufficient
number and types of appropriate
equipments in order to undertake all the
activities and lab. Examinations. These
equipments shall comply with safety
requirements.
• For other laboratory examinations being
performed, the appropriate equipment
necessary for performing such
procedures shall be made available
MINIMUM REQUIREMENTS FOR EQUIPMENT /
INSTRUMENTS
• Primary Category – clinical centrifuge,
microhematocrit centrifuge, microscope
with oil immersion objective,
hemoglobinometer or its equivalent,
differential blood cell counter.
• Secondary Category- All primary
category , refrigerator, Photometer,
Water bath, Timer.
• Tertiary Category- All secondary
category, incubator, Balance, rotator,
Serofuge, Autoclave, Drying oven,
Biosafety cabinet or its equivalent.
GLASSWARES / REAGENT / SUPPLIES
• All categories of clinical laboratories
shall provide adequate and appropriate
glasswares, reagents and supplies
necessary to undertake the required
services.
• WASTE MANAGEMENT
There shall be provisions for adequate
and efficient disposal of waste following
guidelines of the Department of Health
and the local government.
SAFETY
COMMON DECONTAMINATION AGENTS
• Heat
• Ethylene oxide
• 2% glutaraldehyde
• Hydrogen peroxide
• 10% Formalin
• Detergent
• Phenols
• Ultraviolet radiation, Ionizing radiation,
photo-oxidation
LABORATORY HAZARD PREVENTION
STRATEGIES
WORKING PLACE CONTROL
• Hand washing every after patient contact
• Cleaning surfaces with disinfectants
• Avoiding unnecessary use of needles and
sharps and not recapping
• Proper waste disposal
• Immunization for hepatitis
• No eating, drinking and smoking inside the
laboratory
• Warning signs
ENGINEERING CONTROLS
• Puncture proof containers
• Safety needles that retracts after extraction
• Biohazard bags
• Splash guards
• Volatile liquid carriers
• Sensor/ foot controlled sinks
• Biological safety cabinets and fume hoods
PERSONAL PROTECTIVE EQUIPMENT (PPE)

• Nonlatex gloves
• Gowns and laboratory coats
• Mask inc. particle respirators
• Faceshields
• Protective eyewears (goggles)
• Eyewash stations
• Chemical resistant gloves
QUALITY CONTROL PROGRAM

INTERNAL QUALITY CONTROL PROGRAM

• There shall be a documented continuous

competency assessment program for all
laboratory personnel.
• The program shall provide appropriate and
standard laboratory methods reagents
supplies and equipment.
• There shall be program for proper
maintenance of all equipments.
• The program shall provide QC reference
materials.

EXTERNAL QC PROGRAM

• All clinical laboratories shall participate in

External Quality Assurance Program given
by designated National Reference
Laboratories or other Recognized
Reference Laboratories.
• A satisfactory performance rating given by a
National Reference Labs shall be one of the
criteria for the renewal of license.
• Any refusal to participate in EQAP given by
the NRL shall be one of the basis for
suspension revocation of the license of the
laboratory
Microscope
“mickros” – small
”scope” - to see
Units of Measurement

1 µm micrometer = 10-6 m = 10-3 mm

1 nm nanometer = 10-9 m = 10-6 mm
1000 nm = 1 µm
0.001 µm = 1 nm

Microscopy: The Instruments

• A simple microscope has only one lens.

PARTS of MICROSCOPE

• MECHANICAL SYSTEM– Base, Arm,

Stage, Substage, Mechanical Stage
• LENS SYSTEM – Nosepiece, Objectives,
Eyepiece, Focal Length
• OTHER parts - On/OFF switch, Fine/course
adjustment Knob, Iris Diaphragm,
condenser, Light source
• Eyepiece / ocular
10x magnification – magnifies the diameter
of the image 10 x.
• Interpupillary control – adjust lateral
separation of the eyepiece for the user to be
able to focus both eyes
• Objective Lense (3)
Risk Management and Laboratory Safety - 10x –Low power
INSTRUMENTATION 40x- high power
• MICROSCOPE -an optical instrument used 100x –oil immersion
for viewing very small objects that are not 50x - low oil immersion
visible to the naked eye. • Optical tube length
• The science of investigating small objects Distance between the eye piece and
using such an instrument is objective.
called microscopy. 160mm
• In a compound microscope the image from Directs the beam of light from the source
the objective lens is magnified again by the onto the specimen.
ocular lens. • Iris diaphragm
• Total magnification = objective lens Regulates the light that illuminates the slide.
ocular lens • Source of light
• Neck/Arm site for attachment for nosepiece
• Revolving nosepiece
• Focus control
Fine and coarse adjustments
• Stage
Contains movable assemble to facilitate the
study of the different parts of the slide.
• Stage control
 • Condenser

Bright field Microscope

Microscopy: The Instruments

• Resolution is the ability of the lenses to

distinguish two points.
• A microscope with a resolving power of 0.4
nm can distinguish between two points ≥ 0.4
nm.
• Shorter wavelengths of light provide greater
resolution.
• Refractive index is the light- bending ability
of a medium.
• The light may bend in air so much that it Brightfield Illumination
misses the small high-magnification lens.
• Immersion oil is used to keep light from
bending. • Utilized transmitted light
• Dark objects are visible against a bright
background.
Compound Light Microscope • Light reflected off the specimen does not
• 2 sets of lenses one magnifying the image enter the objective lens.
then the other finally enlarging the image
further in an image appearing inverted and
laterally reversed
Electron microscope

• a type of microscope that uses a beam of

electrons to create an image of the
specimen. It is capable of much higher
magnifications and has a greater resolving
power than a light microscope, allowing it to
see much smaller objects in finer detail.
Dark Field Microscope
– Optimum contrast and resolution to maximize
specimen details with precise focusing of light path
Microscopy: Dark Field
• Greater resolution
• Light reaches specimens only from the side
• Only the specimen itself is illuminated

Microscopy: Phase Contrast

• May be used to visualize live samples and

avoid distortion from cell stain
• Image contrast is derived from the
differential refractive index of cell structures
Differential Interference Contrast Microscopy

• Dual beam optical system (light)

• Accentuates diffraction of the light that
passes through a specimen;
• uses two beams of light. Adding color
• Better contrast
Darkfield Illumination

Fluorescence Microscopy
• Ultilized reflected light with a special
condenser • Uses UV light.
• Light objects are visible against a dark • Fluorescent substances absorb UV light and
background. emit visible light.
• Light reflected off the specimen enters the • Cells may be stained with fluorescent dyes
objective lens. (fluorochromes).
• Detect antigen and antibodies
Phase-Contrast Microscopy
• Visualization of auto fluorescent cell
• Accentuates diffraction of the light that structures (e.g., chlorophyll) or fluorescent
passes through a specimen. stains
• Direct and reflected light rays are combined • Can greatly increase the resolution of cells
at the eye. Increasing contrast and cell structures
• Binary fission, motility and endospore • Many functional probes available
Confocal Microscopy

• Uses fluorochromes and a laser light.

• The laser illuminates each plane in a
specimen to produce a 3-D image.
• Vertical and horizontal cross section are
examined
Electron Microscopy

• Uses electrons instead of light.

• The shorter wavelength of electrons gives
greater resolution.
Transmission Electron Microscopy (TEM)
• Transmission electron microscopy (TEM) is
a microscopy technique in which a beam of
electrons is transmitted through an ultra-thin
specimen, interacting with the specimen as
it passes through
• Ultrathin sections of specimens.
• Light passes through specimen, then an
electromagnetic lens, to a screen or film.
• Specimens may be stained with heavy
metal salts.
Scanning Electron Microscopy (SEM)
• A scanning electron microscope (SEM) is a
type of electron microscope that produces
images of a sample by scanning it with a
focused beam of electrons.
• An electron gun produces a beam of
electrons that scans the surface of a whole
specimen.
• Secondary electrons emitted from the
specimen produce the image.
Scanning-Probe Microscopy
• Scanning tunneling microscopy uses a
metal probe to scan a specimen.
• Resolution 1/100 of an atom.
• Atomic force microscopy uses a metal and
diamond probe inserted into the specimen.
• Produces 3-D images.
Risk Management and Laboratory Safety -
INSTRUMENTATION
CARE and USE of MICROSCOPE
• Dust Microscope and the outer surface of
lenses objectives with lens paper or Air bulb
must be used when lens paper is not
available
• Eyepiece should be polished to remove dust
and finger marks and should be checked for
critical illumination
• Check for dust on the rotating nosepiece
and if dust is present should be dismantled
and both lenses be cleaned
• Condenser should also be aligned and
checked for dust particles
• Microscope should be covered when not in
use
• Always support the microscope when
carrying. It should be cradled on hand
holding it by the arm, the other supporting
the base.
LABORATORY BIOSAFETY AND BIOSECURITY
Biosafety
• Biosafety is the prevention of large-scale
loss of biological integrity, focusing both on
ecology and human health.
• It is a system for the safe handling of toxic
and dangerous biological and chemical
substances
• In Medicine-
• It refers to the levels of lab containment
protocols, measured as Bio Safety Level
(BSL)1, 2, 3, 4 in rising order of danger
What is biosafety in the laboratory?
• describes the use of biosafety principles
and practices in laboratories to reduce the
health-related risks associated with handling
infectious agents, toxins, and other
biological hazards arising from accidental
exposure or unintentional release.
• Laboratory biosecurity refers to the
protection, control of, and accountability for
high-consequence biological agents and
toxins, and critical relevant biological
materials and information within laboratories
to prevent unauthorized possession, loss,
theft, misuse, diversion, and accidental or
intentional release
Why is laboratory biosafety important?
• Laboratory biosafety and biosecurity are
important to ensure researchers' safety, especially
from laboratory-acquired infections (LAIs), and to
protect the public from accidental or intentional
exposure to infectious pathogens
HISTORY OF LABORATORY BIOSAFETY
• 1943- origins of biosafety is rooted in the
US biological weapons program
Ira L. Baldwin- first scientific director of
Camp Detrick. He was tasked with
establishing the biological weapons
programs for defensive purposes
• 1969- US president Richard Nixon
terminated such program
Newell A. Johnson- designed modifications
for biosafety at Camp Detrick. He developed
Class III safety cabinets and laminar flow
hoods to address specific risks.
HISTORY OF LABORATORY BIOSAFETY
• 1984- formation of the American Biological
Safety Association (ABSA)
• Arnold Wedum (1907-1908)- described the
use of mechanical pipettors to prevent
laboratory-acquired infections
• 1909- A pharmaceutical company in
Pennsylvania developed a ventilated
cabinet to prevent infection from
Mycobacterium tuberculosis
HISTORY OF LABORATORY BIOSAFETY
• 1967- WHO pursued the eradication of the
Small pox virus
Serious concerns about biosafety practices
worldwide were raised
• 1974- CDC published the Classification of
Etiologic Agent based on Hazard
• 1976- NIH published the Guidelines for
Research Involving Recombinant DNA
Molecules. It explained in detail the
microbiological practices, equipment and
facility necessarily corresponding the four
ascending levels of physical containment.
HISTORY OF LABORATORY BIOSAFETY
• 1984- published first edition of the biosafety
in microbiological and biomedical
laboratories. These documents established
the model of biosafety containment levels
with certain agents.
• Biosafety levels- technical means of
mitigating the risk of accidental infection
from or release of agents in the laboratory
setting as well as in the community and
environment it is situated in.
• Biosafety officers- ensure that the proper
equipment and facility controls are in place
based on the specified biosafety levels of
the laboratory
HISTORY OF LABORATORY BIOSAFETY
• Arnold Wedum- one of the pioneers of
biosafety that provided the foundation for
evaluating the risks of handling infectious
microorganisms.
• 1966- Alfred Wedum and Morton Reitman
analyzed multiple epidemiological studies of
laboratory-based outbreaks.
HISTORY OF LABORATORY BIOSECURITY
• 1906- US government enacted the Select
Agent Regulations to monitor the transfer of
select list of biological agents
• 2012- revision of Select Agent Regulations
➢ Tier 1 agents- materials the pose the
greater risk of deliberate misuse
HISTORY OF LABORATORY BIOSECURITY
Other countries biosecurity regulations for
bioscience facilities:
• Biological Agents and Toxins Act
• Act on Prevention of Infectious Diseases
(2005)- require institutions that work with
listed “highly dangerous pathogens” to
implement laboratory biosafety and
biosecurity requirements
• Infectious Disease Control Law –
established four schedules of select agents
that are subject to different reporting and
handling requirements
LOCAL AND INTERNATIONAL GUIDELINES
LABORATORY BIOSAFETY AND BIOSECURITY
Comité Européen de Normalisation- published the
CEN workshop agreement 15793. This agreement
intended to maintain a biorisk management system
among diverse organizations and set out
performance-based requirements for implementing
a national biosafety system
Laboratory Biosafety Manual- includes information
on the different levels of containment laboratories
(biosafety levels 1-4), different types of biological
safety cabinets, good microbiological techniques,
and how to disinfect and sterilize equipment.
LOCAL AND INTERNATIONAL GUIDELINES
LABORATORY BIOSAFETY AND BIOSECURITY
• Cartagena Protocol on Biosafety- provides
an international regulatory framework to
ensure “an adequate level of protection in
the field of safe transfer, handling and the
use of living modified organism resulting
from modern biotechnology”
• National Committee On Biosafety Of The
Philippines (NCBP)
Procedures:
➢ Evaluation of proposal for biosafety
concerns
➢ Procedures and guidelines on the
introduction, movement and field
release of regulated materials
➢ Physicochemical and biological
containment
DIFFERENT ORGANIZATION IN THE FIELD OF
BIOSAFETY
• American Biological Safety Association- it
promotes biosafety as a scientific discipline
and provides guidance to its members on
the regulatory regime present in North
America
• Asia Pacific Biosafety Association- acts as a
professional society for biosafety
professionals in Asia- pacific region. Active
members of the international biosafety
working group are required to directly
contribute to the development of the best
biosafety practices.
• European Biological Safety Association
(EBSA)- focuses on encouraging and
communicating among its members
information and issues on biosafety and
biosecurity as well as emerging legislation
and standards
• Philippine Biosafety And Biosecurity
Association (PhBBA)- assist DA and DOH in
their efforts to create a national policy and
implement plan for laboratory biosafety and
biosecurity
 • Biological Risk Association Philippines
(BRAP)- a nongovernment and nonprofit
association that works to serve the
emergent concerns of biological risk
management in various professional fields
such as in health, agriculture and
technology sectors throughout the country.
FUNDAMENTAL CONCEPTS OF LABORATORY
BIOSAFETY AND BIOSECURITY
Biosafety - Containment principles, technologies
and practices that are implemented to prevent
unintentional exposure to pathogens and toxins, or
their accidental release
Biosecurity- refers to the protection, control and
accountability for valuable biological materials
within laboratories, in order to prevent their
unauthorized access, loss, theft, misuse, diversion
or intentional release
Charles Baldwin- he created the biohazard symbol
used in labeling biological materials carrying
significant health risks
Biosafety focuses on the laboratory procedures and
practices necessary to prevent exposure to and
acquisition of infections
Biosecurity focuses on the maintenance of secure
procedures and practices in handling biological
materials and sensitive information
CLASSIFICATION OF MICROORGANISMS
ACCORDING TO RISK GROUPS
Risk Groups
• Microorganisms are classified into Risk
Groups according to the degree of risk of
infectivity, pathogenicity, the availability of
preventive measures and effective
treatments, and potential damage to the
environment.
Risk Groups correlate to, but do not always
equate with, biological safety levels.
Risk group classification for humans and animals is
based on agent’s:
• Pathogenicity
• Mode of transmission
• Host range
• Availability of preventive measure
• Effective treatment
• Risk group 1- includes microorganisms that
are unlikely to cause human or animal
disease
• Risk group 2- includes microorganisms that
are unlikely to be a significant risk to
laboratory workers and community,
livestock or environment. Laboratory
exposure may cause infection, however,
effective treatment and preventive
measures are available while the risk of
spread is limited.
• Risk group 3- include microorganisms that
are known to cause serious diseases to
humans or animals and may present a
significant risk to laboratory workers. They
bring about high individual risk, and limited
to moderate community risks
• Risk group 4- includes microorganisms that
are known to produce life-threatening
diseases in humans or animals. It
represents a significant risk to laboratory
workers. They bring about high individual
and community risk.
CATEGORY OF LABORATORY BIOSAFETY
ACCORDING TO LEVELS

• Biosafety level 1 (BSL-1)- is suitable for

work involving viable microorganisms that
are defined and with well- characterized
strains known not to cause disease in
humans.

• Biosafety level 2 (BSL-2)- is basically

designed for laboratories that deal with
indigenous moderate risk agents present in
the community. It observes practices
equipment, and facility design that are
applicable to clinical, diagnostic and
teaching laboratories consequently
observing good microbiological techniques.

• Biosafety level 3 (BSL-3)- puts emphasis on

primary and secondary barriers in the
protection of the personnel, the community,
and the environment from infectious aerosol
exposure

• Biosafety level 4 (BSL 4)- Is required for

work with dangerous and exotic agents that
pose high individual risks of life-threatening
diseases that may be transmitted via the
aerosol route, for which there are no
available vaccines or treatment.
WASTE MANAGEMENT potentially hazardous of all wastes
generated by the community.
What are Wastes?
• As the volume of the complexity of
these waste increases from their
Waste increasing utilization of the people ,the
risk of transmitting and disposal
• (also known as rubbish, trash, refuse, practices also increase.
garbage, junk, litter, and ort) is unwanted or
useless materials. In biology, waste is any of Waste Categories and their Sources
the many unwanted substances or toxins
• Waste produced in a healthcare facilities are
that are expelled from living organisms,
categorized according to its nature and
metabolic waste; such as urea and sweat.
manner of disposal. This is to avoid mixing
Basel Convention Definition of Wastes various types of wastes and avoiding risk to
waste handlers and transporters.
• “substances or objects which are disposed
of or are intended to be disposed of or are
required to be disposed of by the provisions General Waste
of the law”.
• This type of waste does not pose special
Disposal means handling problem or hazard to human health
or to the environment. It comes mostly from
• “any operation which may lead to resource the administrative and housekeeping
recovery, recycling, reclamation, direct re- functions of the hospital and may also
use or alternative uses (Annex IVB of the include the waste generated during the
Basel convention)” waste generated during maintenance of the
hospital premises.
The definition………… Infectious Waste
• Produced by the United Nations
Statistics Division (U.N.S.D.): "Wastes
are materials that are not prime products
(that is products produced for the market)
for which the generator has no further use
in terms of his/her own purposes of
production, transformation or
consumption, and of which he/she wants
to dispose.
• Wastes may be generated during the
extraction of raw materials, the processing
of raw materials into intermediate and final
products, the consumption of final products,
and other human activities. Residuals
recycled or reused at the place of
generation are excluded." Pathologic Waste

• Pathologic waste includes tissues, organs,

WASTE MANAGEMENT
• Clinical Laboratories and other health care
institution are wastes generators. It is a
common knowledge that certain categories
of waste from these institutions are
body parts, human fetus, blood and other
body fluids. A huge amount of laboratory
wastes are considered as pathologic due to
the nature of laboratory work and specimen
requirements of various laboratory tests.
Sharps Waste Handling
Waste Handling
Personnel and patients should be made fully aware
of the need to exercise extreme caution when
handling substances which are to be discarded as
waste
1. Segregation
at source should always be the responsibility of
procedures; thus patients should be made aware of
their roles on handling waste of the health hazards
associated with contamination of infectious
materials
Genotoxic Waste
2. PPE
should be made available to the health care
personnel who collect and handle health care
waste

3. Provisions for adequate supply of appropriately

marked or coded containers of suitable strength
and durability in safe yet convenient location
throught th area where waste is being generated.
4. A system of making coding or identification
Chemical Waste
should be understood by all laboratory especially
• This class of waste consists of discarded for personnel engaged in the collection of waste for
solid, liquids and gaseous chemicals from disposal off sites that appropriate handling and
diagnostic processes, cleaning, disposal techniques are employed.
housekeeping and disinfecting
procedures. Chemical waste is considered
5. Appropriate codes of practice must be enforced
hazardous and may have at least
on both ends of the waste disposal system.
mutagenic, teratogenic or carcinogenic
properties
• Toxic Waste Collection
• Corrosive
The proper collection of waste is an important
• Flammable
component of health car waste management. Its
• Reactive
implementation requires the direct involvement of
• Genotoxic
the hospital’s maintenance, housekeeping, motor
• Chemical waste with none of the above pool and cooperation of all health care personnel.
properties such as sugars, amino acids
certain organic and inorganic salts are
considered non hazardous Guidelines

Pressurized Containers • Waste collection is done once every shift

• Lab staff should ensure that waste bags are
• Storage of inert gases used in health care in
tightly closed or sealed when they are about
pressurized cylinders catridges aerosols three quarts full
cans belong to this category
• Waste must be collected daily or as
frequently as required
 • Bags or containers should be replaced
immediately with new ones of the same
type.
• Supply of fresh collection of waste bags or
containers should be readily available.
• Color Coding of waste storage must be
implemented.
Color Coding for Waste Storage
Guidelines
• Sharps must be collected together in a
puncture proof and fitted with cover
containers
• Bags and containers of infectious waste
should be marked with international
infectious substance symbol
• Cytotoxic waste should be collected in
strong,leak proof containers clearly labelled
cytotoxic wastes
• Large quantities of chemical waste should
be packed in chemical resistant container
and sent to specialized treatment facilities
or returned to its supplier.
• Aerosol containers may be collected with
general health carte waste once they are
completely empty.
Waste Storage
• All health care waste should be collected
and
stored in waste storage area until
transported
to a designated off site treatment facility
• This area should be within the hospital
premises but should be away from patient
rooms laboratories hospital
functions/operation rooms or any public
access areas. Waste should not permit the
transmission of communicable diseases,
create a nuisance and provide a breeding
place for vermin.
This should be treated regularly with
insecticide,pesticide and disinfectant. Storage
facilities should have
• An impermeable and easy to disinfect floor
with good drainage
• Water supply for cleaning purposes
• Access for staff in charge of handling the
waste
• Protection against entry of unauthorized
person
• Easy Access to waste collection vehicle
• Protection from environmental factors like
sun,rain,strongwinds,floods ect
• Protection against accessibility to animals
insects or birds
• Good Lightning and ventilation
• Adequate supply of cleaning equipment
protective clothing and waste bags or
containers located to the area
Waste Transport
• Waste from healthcare facilities should be
responsible in the proper transport of waste
produced in the performance of laboratory
testing
On site Transport
• The Transport of waste within
establishments utilizes containers and
wheeled trolleys that are dedicated solely
for waste transport.The on site transport
vehicle should meet the ff criteria:
• Easy to clean
• Easy to Load
• No sharp edges that can damage waste
bags or containers during loading and
unloading
• The on site collection vehicle should be
cleaned and disinfected daily with an
appropriate disinfectant like chlorine
compounds formaldehyde phenolic
compounds and acids. All wastes bags
seals should be place and intact at the end
of transportation
• Workers transporting the waste should be
equipped with appropriate personal
protective equipment including heavy duty
gloves thick soled boots and leg protection
OFF SITE TRANSPORT

• The health carte waste generator or hospital

is responsible for the safe packing and
adequate labelling of should comply with the
national and local regulations governing the
transport of hazardous wastes
• Collection vehicles used for the transport of
healthcare wastes should not be used for
transport of any other kind of materials that
could be seriously affected by contamination
such as food livestock and people.
• The vehicle should have an enclosed leak
proof body and capable of being locked to 1. In-lab Hazard Reduction
secure the waste. Lab reduction and Segregation

• Segregation at point oforigin

• Segregation of infectiouswaste with multiple
hazards
• Use of distinctive, clearly marked containers
or plastic bags
• Use of the universalbiological hazard
symbol

2. Waste Characterization
DOH-Healthcare WM Guide

• Non-infectious dry waste-Trash Bin/Plastic

Philippine Regulations on WM
• RA 6969 - Toxic Substances and Hazardous
and Nuclear Wastes Control Act of 1990
• Presidential Decree No. 856 s 1975- “The
Code of Sanitation of the Philippines”
• DOH DC # 156-C series of 1993- “Provides
Guideline in Hospital Management”
• RA 8749- (Clean Air Act of 1999)
• RA 9003- (Ecological Solid Waste
Management Act of 2001)
• RA 9275- (Clean Water Art of 2004)
• PD 1586- (Environmental Impact Statement
System Law)
bags
• Non-infectious wet waste- Trash Bin/Plastic
bags (foodstuff)
• Infectious Pathologic waste- Plastic bag
(double bagging)
• Sharps- Puncture proof container
• Radioactive waste- Lead Storage
Containers
• Non-infectious recyclables- Trash
Bin/Plastic bags (bottles)
3. Collection and Storage
7-points for Academic institutions
1. Labeling standards
2. Facility/container standards
3. Training requirements
4. Removal of unwanted chemicals
5. Hazardous waste determination
6. Laboratory cleanout
7. Prevention of emergencies and
response
Labeling standards: Basic form 5. Hazardous Waste Manifest
6. Records & Record Keeping

Storage Facility
a. Accessible (butnot outsiders)
b. Enclosed storageand proper ventilation
c. Resistant and retain spillage floors
d. Segregate waste

4. Treatment and Disposal

Transport
Wheeled trolleys should be:

• Authorized for the purpose

• Easy to load and unload
• No sharp edges
• Easy to clean
- disinfect daily