Laboratory Biosafety and Biosecurity Standards Manual

2023
Department of Health
Republic of the Philippines
Laboratory Biosafety and Biosecurity Standards
©2023 by the Department of Health. All rights reserved.

Subject to the acknowledgment of the Office for Health
Laboratories (OHL), Department of Health, the Manual may
be freely abstracted, reproduced or translated in part or in
whole for non-commercial purposes only. If the entire
Manual or substantial portions will be translated or
reproduced, permission should be requested from OHL.
Printed in the Republic of the Philippines.
National Library Cataloging-in-Publication Data
ISBN
Published by Department of Health

San Lazaro Compound
Rizal Avenue, Sta. Cruz, Manila
1003 PHILIPPINES
Development of this Manual was initiated and completed, and

subsequently published through the Office for Health Laboratories,
Department of Health, Manila.Contact OHL for inquiries:
(02) 8995-3846 local 404, (02) 8875 7734.
Email address: ohl@doh.gov.ph
REPUBLIC OF THE PHILIPPINES
DEPARTMENT OF HEALTH
OFFICE OF THE SECRETARY
MESSAGE
As one Department of Health, I express my warmest congratulations

to the Office for Health Laboratories for publishing the second edition
of the Manual of Standards for Laboratory Biosafety and Biosecurity.
With the DOH at the helm, the Philippines was able to make
significant strides over the years improving the nation’s state of health
through programs such as maternal care and child health programs,
tuberculosis (TB) program and cancer program that provide
affordable healthcare services and improve infrastructure in
underserved areas.
As the national technical authority on health, in fulfilling our mandate to ensure the highest
achievable standards in health, the Department presents to our partners the Laboratory Biosafety
and Biosecurity Standards. Biosafety and Biosecurity are a matter of interest both timely and
enduring among partners and stakeholders of the health system.
To further push for the full realization of Universal Healthcare (UHC) Act in the country, the
Department also banners its newly-established 8-point Agenda, a health campaign that aims to
effectively push for a more integrated healthcare system that connects the Filipino people to the
country’s health sector, wherever they may be. Highlighting its second agenda “Ligtas, dekalidad,
at mapagkalingang serbisyo” (Safe, quality, and caring service), our Department aims to provide
better health centers and integrated healthcare networks all geared towards responding to the
needs of Filipinos.
Once again, my sincerest gratitude to the Office for Health Laboratories for making this Manual a
significant contribution in vesting further capacity to our laboratories, fulfilling their respective roles
in the health system with quality, safety, and efficiency. Kapag sama-sama, mas kaya nating
abutin ang ating layuning makapagtaguyod ng sustainable health para sa lahat!
1
MESSAGE
Greetings and salutations from the Health Systems

Development Team of the Department of Health!
The Department of Health plays a vital role in ensuring

the well-being and safety of the nation, especially during
times of widespread public health crises like the COVID-
19 pandemic. As COVID-19 has profoundly impacted
communities worldwide, the success or failure of public
health departments in combating the virus is of
paramount importance.
The COVID-19 pandemic highlighted the need for an efficient laboratory in understanding
and combating this virus. Our laboratorians worked tirelessly to identify, isolate, and study
the virus. Laboratories play a critical role in scientific research, diagnostics, and the
development of new technologies. The safety and security of laboratories are also
significant to prevent potential hazards and misuse of biological materials.
Laboratory Biosafety and Safety Standards serves as our comprehensive guide which
discusses a wide range of topics in biosafety and biosecurity from biorisk assessment to
emergency preparedness. Adherence to standards, guidelines, practices, and protocols is
key in ensuring the highest level of biosafety and biosecurity in these laboratories. As the
country’s technical authority in health, we are to present with our fellow healthcare
partners this valuable reference to clinical and public health laboratories in our country.
This is DOH’s testament to our commitment in providing quality laboratory services to all.
DR. LILIBETH C. DAVID, MPH, MPM, CESO I

Undersecretary of Health
2
MESSAGE
On behalf of the Health Facility and Patient Support Team of

the Department of Health, I extend my greetings to my fellow
stewards of health.
As the principal health agency in the Philippines responsible

for ensuring access to basic public health services to all
Filipinos through the provision of quality health care and
regulation of providers of health goods and services, the
Department of Health plays a crucial role in managing public
health and implementing policies that address various health
concerns. The Department is also mandated to provide
national policy direction and to develop national plans,
technical standards and guidelines on health.
One of the pressing issues in the recent Covid-19 pandemic which dramatically impacted the
diagnostic service provision was the adherence to the required biosafety and biosecurity protocols.
To address the laboratory gaps which were identified during the recent pandemic and to better
prepare our healthcare system in handling novel viruses such as the COVID 19, the Office for Health
Laboratories, with the help of our biosafety and biosecurity experts, formulated the Manual of
Standards for reference and guidance of our laboratories with a view to creating a safe and secure
working environment for everyone.
In this light, we are here to present to our stakeholders the laboratory biosafety and biosecurity
standards manual to ensure implementation of effective laboratory biosafety and biosecurity
practices to reduce the risk of accidental or intentional release of hazardous biological agents or
materials while also providing a safe working environment for healthcare personnel.
3
MESSAGE
On behalf of the Office for Health Laboratories of the

Department of Health, I extend my salutations to my fellow
laboratorians and allied health professionals.
In the recent Covid-19 pandemic, one of the impediments

which greatly impacted the diagnostic service provision was
the adherence to the required biosafety and biosecurity
protocols. Our healthcare system, without the exemption of the
diagnostic field, was then unprepared to handle such a novel
virus.
Amidst all what happened, the government and the private sectors bounced back altogether and
helped each other to address our health care gaps. We, in the Department of Health, supports all
efforts from our partners to ensure the highest achievable standards in our laboratories through
implementation of effective laboratory biosafety and biosecurity practices to reduce the risk of
accidental and/or intentional release of hazardous biological agents or materials while providing a
safe working environment for personnel and the environment.
With that, I am delighted to present this manual of laboratory biosafety and biosecurity standards
with utmost appreciation to the relentless effort of my team, Office for Health Laboratories, the
experts who shared their knowledge and to our cluster teams, HFIDT and HFPST who supported us
in making this possible.
4
FOREWORD
The DOH Health Sector Strategy for 2023-2028 defines the country’s vision, policy and
direction and strategic objectives needed to accelerate the achievement of Universal Health
Care (UHC) and to further build the health system’s resilience against future pandemics and
emergencies. Two of the four major pillars of this framework which are giving access to both
public and private health care delivery systems, and capacitating measures to bolster the
health system in support of other outcomes, the Office for Health Laboratories assumes
technical leadership in ensuring delivery of quality clinical and public health laboratory and
diagnostic services in a timely, sustainable, and efficient manner through the Philippine
Health Laboratory System.
Health workers and Health Facility/Hospital Administrators have been continuously

confronted with a wide range of issues, new trends and technologies in various health care
settings and the laboratory is not exempted from this. The development of more relevant
and responsive policies and guidelines for both patients quality care and personnel safety
attunes our health systems to this dynamic environment.
For 2023, the Office for Health Laboratories proudly endorses the 2nd edition of the
Laboratory Biosafety and Biosecurity Standards Manual for all clinical and public health
laboratories. The authors and contributors in the conceptualization and completion of these
manuals are experts in laboratory biosafety and biosecurity with various fields in laboratory
medicine. This manual is in congruence with Philippine settings while maintaining
consistency with international standards.
This will serve as a standard reference material for the DOH Clinical and Public Health
Laboratories to aid laboratory administrators and personnel in the management and
operations of various laboratory services that contribute directly and indirectly to quality
patient care.
The 2nd edition of the Department of Health’s Standards for Laboratory Biosafety and
Biosecurity adopts the risk-based approach emphasized in the 4th edition of the WHO
Laboratory Biosafety Manual. This is to ensure that application of recommendations to
laboratory facilities, safety equipment and work practices are locally-relevant and
sustainable.
5
FOREWORD
The primary intended scope of this manual is to address handling, management, and
containment of biological agents and materials that pose threat to human health as well
as prevention of their unauthorized access, loss, theft, misuse, diversion or intentional
release in government and private clinical laboratories as well as public health
laboratories.
Other health laboratories (i.e. Analytical Toxicology Laboratories, Drug Testing

Laboratories, Water Testing Laboratories, and Other Academe Laboratories) are
encouraged to use this manual as guidance if applicable.
Laboratories that perform testing of animal and plant related products may also use this
manual as guidance if applicable.
6
PREFACE
Biosafety and biosecurity refer to a nation’s ability to respond effectively

to biological threats and related factors. This requires a nation to maintain and protect its
own safety and interests. Such requirements include the prevention and control of major
emerging infectious diseases, defensive action against biological weapon attacks, the
prevention of bioterrorism attacks, the prevention of biotechnology abuse, the protection of
laboratory biosafety, the protection of special biological resources, and the prevention of
invasion by alien organisms.
During the SARS-CoV2 pandemic, one of the critical aspects of laboratory operations was
biosafety and biosecurity protocols, with its importance highlighted especially in novel
microorganisms handling. Laboratory biosafety and biosecurity activities are fundamental to
protecting the laboratory workforce and the wider community against unintentional
exposures or releases of pathogenic biological agents. These activities are implemented
using a risk assessment framework and through the development of a safety culture which
is needed to ensure a safe workplace where adequate measures are applied to minimize
the likelihood and severity of any potential exposure to biological agents.
The need to update local laboratory biosafety and biosecurity guidance is part of a broader
initiative to globalize biorisk management and emphasize the principles and approaches
that are accessible to countries with a broad range of financial, technical and regulatory
resources. In the past international guidelines for biosafety and biosecurity, classifications of
biological agents and laboratories in terms of risk/hazard groups and biosafety/containment
levels were the key considerations . While this may be a logical starting point for the
handling and containment of biological agents, it has led to the misconception that the risk
group of a biological agent directly corresponds to the biosafety level of a laboratory. In fact,
the actual risk of a given scenario is influenced not only by the agent being handled, but
also by the procedure being performed and the competency of the laboratory personnel
engaging in the laboratory activity.
7
PREFACE
With reference to the latest edition of the standards promoted by the World Health
Organization on Laboratory Biosafety and Biosecurity, this manual also focuses on
evidence-based and transparent assessment of the risks allowing safety measures to be
balanced with the actual risk of working with biological agents on a case-by-case basis.
Application of the recommendations will enable countries to implement economically-
feasible and sustainable laboratory biosafety and biosecurity policies and practices that are
relevant to their individual circumstances and priorities.
With the country’s commitment to the International Health Regulations (IHR), the legally-
binding international agreement designed to prevent the spread of disease, the Department
of Health spearheads the crafting of standards for laboratory biosafety and biosecurity so
that our nation shall be able to respond to future pandemics and epidemics.
8
ACKNOWLEDGMENTS
The Laboratory Biosafety and Biosecurity Standards Manual was made possible
through the contributions of the following whose expertise is gratefully
appreciated.
TECHNICAL WORKING GROUP
Dr. Valerie Anne Tesoro Chairperson Office for Health Laboratories
Dr. Vita B. Gasataya Member South Cotabato Provincial Hospital
Mr. Plebeian B. Medina Member Research Institute of Tropical Medicine
Mr. Edsel Allan Salonga Member UP Manila - Institute of Human Genetics
Engr. Ricardo Bote Member St. Luke's Medical Center
Philippine Science High School Western

Mr. Harold Mediodia Member
Visayas Campus
V Luna Medical Center, AFP Health

Ms. Jocelyn Sysing-Aquisay Member
Service Command
Mariano Marcos Memorial Hospital and

Mr. Allan Fellizar Member
Medical Center
Philippine Navy
Col. Peter Tom Alangui Member
Armed Forces of the Philippines
Learning Unit V, College of Medicine

Jonathan Jaime Guerrero Member
University of the Philippines-Manila
9
ACKNOWLEDGMENTS
We also acknowledge the inputs from the following experts:
Ms. Catherine Anne Sacopon Research Institute for Tropical Medicine
Ms. Delaram Akhavein World Health Organization
Dr. Sabai Phyu Regional Public Health Laboratories Network
Ms. Camille Ann C. Ople Technical Writer
Dr. Rohani Cena-Navarro UP Manila - National Institutes for Health
Technical Secretariat
Dr. Hyacinth Joy Balderama

Division Chief
Dr. Toni Rose Lamata-Porras Dr. Carole Zaidel Rosales
Ms. Nenita Marayag Ms. Leodymar Jorduela
Mr. Richard Albert Ramones Architect Jean Paolo Policarpo
Ms. Trisha May Sarabia Ms. Joan Guevara
Mr. Lysander Linus De Leon Mr. Teddy Mondres
Mr. Alvin Duazo Mr. Ronald Pastoral
10
PAGE
Message . . . . . . . . . . . . . . . . . . . . . 1
Foreword . . . . . . . . . . . . . . . . . . . . 5
Preface . . . . . . . . . . . . . . . . . . . . . 7
Acknowledgments . . . . . . . . . . . . . . . . . 9
List of Acronyms . . . . . . . . . . . . . . . . . . 13
Definition of Terms . . . . . . . . . . . . . . . . . 14
CHAPTER 1 BIORISK MANAGEMENT SYSTEM

● Identify the hazards and risks . . . . . . . . . . . . 22
● Characterize and evaluate the risks . . . . . . . . . . 22
● Develop a risk control strategy . . . . . . . . . . . 23
● Selection of appropriate and sustainable risk control measures . . 23
● Risk Evaluation and Acceptability . . . . . . . . . . . 24
● Periodic review of Risk Assessment . . . . . . . . . . 24
● Risk Communication . . . . . . . . . . . . . . . 24
STANDARDS (Biorisk Management System) . . . . . . . 26
CHAPTER 2 ROLES, RESPONSIBILITIES AND AUTHORITIES

● Leadership and Commitment . . . . . . . . . . . . 27
● Biorisk Officer . . . . . . . . . . . . . . . . . 27
● Biorisk Policy . . . . . . . . . . . . . . . . . 27
● Roles and Responsibilities . . . . . . . . . . . . . 28
STANDARDS (Roles, Responsibilities and Authorities) . . . . 29
CHAPTER 3 BIOSAFETY
Core requirements, Heightened and maximum control measures
● Good microbiological practice and procedure . . . . . . . 31
● Personnel competence and training . . . . . . . . . . 32
● Facility design . . . . . . . . . . . . . . . . . 32
● Specimen receipt and storage . . . . . . . . . . . . 32
● Decontamination and waste management . . . . . . . . 32
● Personal protective equipment . . . . . . . . . . . 33
● Laboratory equipment . . . . . . . . . . . . . . 33
● Emergency/incident response . . . . . . . . . . . . 34
● Transfer and transportation of Infectious Substances, Biological
Specimens . . . . . . . . . . . . . . . . . . 34
● Occupational health . . . . . . . . . . . . . . . 35
STANDARDS (Biosafety) . . . . . . . . . . . . . . 36
CHAPTER 4 BIOSECURITY
● Biosecurity Awareness . . . . . . . . . . . . . . 37
● Personnel Reliability . . . . . . . . . . . . . . . 37
● Information Security . . . . . . . . . . . . . . . 38
● Material Control and Accountability . . . . . . . . . . 38
● Emergency/Incident Response . . . . . . . . . . . 38
● Management . . . . . . . . . . . . . . . . . 39
● Physical Security . . . . . . . . . . . . . . . . 39
● Transport Security . . . . . . . . . . . . . . . 39
STANDARDS (Biosecurity) . . . . . . . . . . . . . 40
Annexes . . . . . . . . . . . . . . . . . . . . 41
References . . . . . . . . . . . . . . . . . . . 63
AO – Administrative Order
BSC – Biological Safety Cabinet
BSL – Biosafety Level
BSO – Biosafety Officer
DA – Department of Agriculture
DOH – Department of Health
GMPP – Good Microbiological Practice and Procedure
HEPA – High-Efficiency Particulate Air
HVAC – Heating, Ventilation and Air Conditioning
IBBC – Institutional Biosafety and Biosecurity Committee
ICC – Infection Control Committee
LAI – Laboratory Acquired Infection
LEED – Leadership in Energy Environmental Design
OHSP – Occupational Health and Safety Program
PPE – Personal Protective Equipment
PDCA – Plan, Do, Check, Act
MCA – Material Control Accountability
MOA – Memorandum of Agreement
MRPT – Moderate Risk Pathogen and Toxin
MSDS – Material Safety Data Sheet
RA – Risk Assessment
SOP – Standard Operating Procedures
VBM – Valuable Biologic Materials
WHO – World Health Organization
13
Accountability – ensures that materials are controlled as intended by formally
associating the specified materials with the people who provide oversight.
Antimicrobial – chemical or physical agent used in the decontamination process to

prevent microbial growth.
Antiseptic – substance that prevents growth of microorganism.
Antisepsis – germicidal inhibition or destruction of microbes on skin or tissue.
Assets - Items of value, such as property and equipment, which the organization owns
or leases in order to operate
Assessment – evaluation using science, observation, experience, professional practice

and standards and common sense.
Autoclave – piece of equipment with a chamber that is used to sterilize items by

applying heat (i.e. high pressure steam) at temperatures above the normal boiling point
of water and pressures above normal atmospheric pressure.
Biohazard – hazard created by potential transmission of a microbiological agent or

pathogen to a susceptible host.
Biohazardous – pertains to biological materials that present potential/detrimental risk to

the health of humans or other organisms, either directly, through infection or indirectly,
through damage to the environment.
Biological materials – a broad range of organisms, cells, viruses, and other materials
of biological origin that pose different levels of risks to plants, animals, or humans.
Biological products – products derived from living organisms which are manufactured
and distributed in accordance with the requirements of appropriate national authorities,
which may have special licensing requirements, and are used either for prevention,
treatment or diagnosis of disease in humans or animals, or for development,
experimental or investigational purposes related thereto.
14
Biorisk Committee - A committee that assists the management in identifying,
developing and reaching biorisk management goals. This committee also oversees and
guides the entire facility in terms of biorisk management programme.
Biorisk management system - Refers to the effective management of risks posed by

working with infectious agents and toxins in laboratories; it includes a range of practices

and procedures to ensure the biosecurity, biosafety, and biocontainment of those
infectious agents and toxins. Biorisk management includes the full spectrum of safety
and security measures for laboratories, from standard operating procedures to physical
measures to individual practices in the laboratory.
Biosafety – refers to the measures undertaken to protect workers from hazards due to
the nature of work and to prevent the spread of hazardous agents from the laboratory.
Biosafety cabinet or biological safety cabinet (BSC) – a hood with high- efficiency
particulate air (HEPA) filters that provides personnel, environmental and/ or product
protection when appropriate practices and procedures are followed.
Biorisk Officer – An individual that has advisory functions to the management on

establishing and monitoring workplace biosafety and biosecurity procedures which is
designed to minimize or prevent injury or loss due to biohazards as well as its security.
Commissioning – Process of ensuring that all systems and components of a building

are designed, installed, tested, operated, and maintained according to the operational
requirements of the owner and users. This may be applied not only to new projects but
also to existing units and systems subject to expansion, renovation or revamping.
Community – encompasses both human (i.e., the public) and animal populations
Containment – combination of personal practices, procedures, safety equipment,

laboratory design, and engineering features to minimize the exposure of workers to
hazardous or potentially hazardous agents.
15
Contingency Plan for evacuation – plan devised for a specific situation when things
go wrong in the laboratory. It contains specific strategies and actions in prevention of
particular problems or emergencies to recover from serious incidents in the minimum
time with minimum cost and disruption.
Control – combination of engineered and procedural measures that ensure materials

are used only as intended and not diverted for malicious or unknown use.
Corrective maintenance – involves minor repair of building elements and minor

servicing of equipment to correct confirmed abnormalities or deteriorating conditions.
Decommissioning - Removal/ceasing the use of installed equipment/s and/or facility,

or part thereof, including decontaminating and dismantling the equipment to such an
extent that it can no longer be used.
Decontamination – inactivation or removal of contaminants to an acceptable level.
Disease – refers to a specific illness or medical condition, irrespective or origin or

source that presents or could present significant harm to humans.
Disinfection – selective killing or inactivation of contaminants to include viruses and

vegetative bacteria which may not kill spores.
Dual Use Research of Concern - is/are research/es conducted for legitimate purposes
that generates knowledge, information, technologies, and or products that can be
utilized both for benevolent and harmful purposes.
Effluents - Liquid waste or sewage discharged into the sanitary sewer
Emergency Alert and Warning System – warning that uses all available means of
communication providing a standardized alert protocol and develops infrastructure for
notification to geographically appropriate community of responders and affected
personnel, and individuals.
Export Control System – scheme to put a regulation and restriction in the distribution
overseas or abroad of strategic goods, VBM, dual use commodities, technologies,
software, etc.
16
Eyewash – device used to irrigate and flush the eyes.
Genetically modified microorganisms and organisms – microorganisms and

organisms in which genetic material has been purposely altered through genetic
engineering in a way that does not occur naturally.
Germicide – any antimicrobial chemical agent used for disinfection, antisepsis or

sterilization regardless of whether its action is microbicidal or microbiostatic; any
microbicidal disinfectant, antiseptic or sterilant.
Hazard – refers to any situation that has potential to cause damage.
High Complexity Facilities - laboratories performing laboratory tests involving highly

complex specialties involving moderate to high risk organisms where specialized
scientific and technical knowledge is essential to perform preanalytic, analytic or post
analytical phases of the testing. (i.e. Research Institute for Tropical Medicine)
High-Efficiency Particulate Air (HEPA) – a device composed of fibrous materials

capable of trapping and retaining at least 99.97 percent of airborne monodispersed
particles 0.3 micrometers in diameter.
Infectious agent – an infectious microbial (e.g. bacteria, protozoa, fungi, viruses, or

other agents (e.g. prions) that causes disease in healthy humans.
Infectious substances – substances which are known or are reasonably expected to

contain pathogens.
Institutional Biosafety and Biosecurity Committee (IBBC) - A committee that

reviews, approves and oversees research involving the use of recombinant or synthetic
DNA/RNA and other biohazards especially for Dual Use Research of Concern (DURC).
This committee provides recommendations to the intramural community in matters
pertaining to the control of biohazards associated with the use of microbiological agents
and their vectors.
17
Internal Review of Performance - An internal review of the organization’s biorisk
management system at planned intervals, to ensure its continuing suitability, adequacy
and effectiveness. The review shall include to assess the needs for changes to the
system, procedures, policies and objectives for continual improvement
Inventory – identifying and listing of all materials, item by item in a particular area.
Laboratory Personnel - Individual/s who work in the laboratory and handle biologic
specimens for testing (i.e. medical technologists, laboratory technicians, phlebotomists,
morgue staff, etc.)
Low Complexity Facilities - Facilities with single laboratories performing routine

clinical laboratory tests requiring minimal scientific and technical knowledge for
preanalytic, analytic and post analytical phases of the testing process. Reagents and
materials being used are generally stable and reliable. (i.e Primary, Secondary and
Tertiary Laboratories)
Medical or Clinical Wastes – wastes generated or produced as a result of the

following: diagnosis, treatment, or immunization of human beings or animals; research
pertaining to the diagnosis and treatment, or immunization of human beings or animals;
or the production of biological testing.
Organization - Refers to laboratories that perform testing of clinical specimens in order

to get information about the health of a patient/population as pertaining to the diagnosis,
treatment, and prevention of disease.
Outer packaging – outermost enclosure of a composite or combination packaging

together with any absorbent materials, cushioning, and any other components
necessary to contain and protect inner receptacles of inner packaging from outside
influences, such as physical damage while in transit.
Pathogen – infectious microbe (e.g. bacteria, protozoa, fungi, viruses, etc.) or other
agent that causes disease in healthy host organisms such as humans, animals, or
plants.
18
Personal Protective Equipment (PPE) – clothing or equipment worn by workers to
protect the body from injury by hazardous agents or materials. Examples of PPE include
foot, hand, eye, face, body and respiratory protection. PPE is one element of biosafety
containment.
Preparedness – organizing of a response prior to an event.
Preventive maintenance – consists of planned, scheduled and cyclic tasks of condition

checking/monitoring, parts replacement, and gathering of data in order to prevent
untimely breakdown of building elements, equipment and utility system, maintain
desired operating performance levels and generate structures and coherent data
needed for planning and decision-making.
Primary barrier – physical barriers (e.g. face mask, gloves, and other PPEs) which are
intended to protect the safety of healthcare workers who are in contact with various
pathogens.
Risk – probability of an adverse effect, harm, injury or disease occurring as a result of

an exposure to one or more hazards.
Risk Group – ranking of a microorganism’s ability to cause injury through disease.
Secondary barrier – contains the agent within the room or facility in case an agent
escapes from the primary barrier, may either be a separate building or located in an
isolated zone inside a building.
Senior management - Person or group of people who is responsible for the creation of
policies and guidelines, as well as for the ongoing support of the laboratory operation
(i.e. Head of the Laboratory, Laboratory Managers)
Severity – estimation of how serious the potential or probable harm it might cause to
people, animals, the environment or damage to property.
Standards – external rules established by the government, contract, and funding

regulations, and non-regulatory standards that form the requirements of the Biosafety
Program.
19
Sterilization – process of ensuring the destruction of contaminants and microbiological
life.
Support Personnel - Individual/s who work in the laboratory that do not necessarily
handle biologic specimens for testing but are exposed to biologic material being
handled in the laboratory (i.e. encoder, administrative personnel, secretary, etc.)
Surveillance – refers to the regular publication with specific information on the disease
under surveillance.
Threat - Anything or anyone that would risk unauthorized access, loss, theft, misuse,
diversion or intentional release of valuable biological material (VBM)
Top management - Person or group of people who directs and controls an organization
at the highest level (i.e. Owner, Medical Center Chief, Director General, etc.)
Toxin – poisonous substance, especially a protein that is produced by living cells or

organisms, and is capable of causing disease when introduced within the body tissues.
Virus – a small infectious agent that can only replicate inside the cells of another
organism
20
Introduction
Risk Assessment (RA), as part of the Biorisk Management System, is a term

used to describe a stepwise process to determine the risks that exist when handling and
storing potentially hazardous biological materials. It is done to identify hazards,
determine the corresponding risk that may arise, and to measure the probability of
occurrence of an incident and consequence resulting from the hazards. Probability
refers to the likelihood of potential occurrence of exposure and release of biohazards
outside of the laboratory. Consequence refers to the severity of the result if an exposure
will occur. Factors such as mode of transmission, infectious dose, host vulnerability
have to be considered in evaluating consequences. Risk Assessment focuses primarily
on the bio-containment measures to prevent laboratory-acquired infections and
reduction of the worker’s and the environment’s risk of exposure to an agent in absolute
minimum.
Risk assessment activities must always be conducted in a systematic and

stepwise manner to ensure reproducibility and comparability. The following steps are
suggested in performing risk assessment activities (Figure 1).
Steps in performing Risk

Assessment:
1. Identify the hazards and

risks
2. Characterize and
evaluate the risks
3. Develop a risk control
strategy
4. Selection of appropriate
and sustainable risk
control measures
5. Risk Evaluation and
Acceptability
6. Periodic review of Risk
Assessment
7. Risk Communication
Figure 1. Risk Assessment Process
21
1. Identify the hazards and risks
In hazard and risk identification, the pathogenic characteristics of a

biological agent is one of the most important factors to be reviewed. However,
the types of procedures that will be performed with the hazardous agent, the
environment in which these procedures will take place, personnel competencies
and equipment used should also be included.
In events of novel biological agents, where detailed data are insufficient

and/or unknown, it is only practical to take caution in handling these potentially
infectious specimens.
2. Characterize and evaluate the risks
Once hazards and risks are identified, it is important to evaluate the risks
that exist. The objectives of this step are: (1) to determine the probability of an
occurrence that might result in exposure and/or release of biological agents in
the environment, (2) to establish the degree of severity of the consequences and
(3) to decide upon whether these risks are acceptable/controllable or not. The
Risk Assessment Matrix as shown in Table 1 should be developed to determine
the relationship of probability and consequences of such events. Risk
Assessment Matrix may differ among facilities/laboratories.
Table 1. Risk Assessment Matrix
22
3. Develop a risk control strategy
To reduce the probability and consequences of the identified risks, a risk

control strategy must be developed for the work to proceed safely. It is important
to note that complete elimination of risks can never be achieved unless the work
is not done at all. Hence, the goal of this step is to reduce the initial risk into a
more acceptable level. Different strategies may be used in order to reduce the
risk successfully. Table 2 presents a list of some of the strategies used for risk
control.
Strategy Example
Elimination ● use alternative work procedures

● Inactivation of biological agents
Substitution ● Use of less harmful substitute agent and/or

procedure
● reduction of amount/volume to be used
Engineering Controls ● use of biosafety cabinets and primary containment

device
Administrative Controls ● Good microbiological practice and procedure

● Training of personnel
● Standard Operating Procedures
Personal Protective ● Use of gloves, goggles, face shields, lab coat,

Equipments masks/respirators, and anything else that would
provide additional protection to your body
Table 2. Strategies used for Risk Mitigation
4. Selection of appropriate and sustainable risk control measures
Once a risk control strategy has been developed, risk control measures
must be selected and then implemented in order to fulfill the risk control strategy.
In risk control measure selection, national policies, regulations and guidelines
must always be considered first. Those outside of these regulations may be
adopted from internationally-accepted practices, principles and technologies to
ensure acceptability of the risks identified.
23
5. Risk Evaluation and Acceptability
After gathering all available information on the circumstances of the work

to be performed, it is necessary to use that information to identify and evaluate
any risks that exist. The goal of the risk evaluation step is to:
● determine the likelihood of an exposure to and/or release of a biological
agent occurring and the severity of the consequences of such an event;
● establish how the likelihood and consequence contribute to the initial risk
of the work to be performed; and
● decide, based on the gathered information of the risk assessment,
whether these risks are acceptable or not; this decision must be justified
and documented comprehensively.
As mentioned earlier, it should always be remembered that even after a

control measure, complete elimination of risk will be impossible and residual risk
will still remain. Multiple risk control measures may be used to further reduce the
residual risk. This would also be beneficial in case of failure of one or more of the
selected control measures. If the evaluated risks are not acceptable, develop
additional appropriate risk control strategies, unless it is decided not to undertake
the work at all.
6. Periodic review of risk assessment
Over time, laboratory processes, personnel and technology changes.

Hence, there should be regular periodic review and performance evaluation of
the risk assessment activity done. This is to confirm that control measures and
training are effective. This will also provide an opportunity for advancements and
improvements.
7. Risk Communication
Risk communication is the interactive exchange of information, advice and

opinions between experts or officials and people to enable people at risk to make
informed decisions to mitigate the effects of a threat/hazard (i.e. disease
outbreak) and take protective and preventive measures. It shapes the laboratory
24
personnel's perceptions of risks and influences their actions with respect to
disaster preparedness and disaster response.
25
The organization shall establish, document, implement and maintain a biorisk
Standard 1.
management system.
The organization shall have a biorisk management policy that:

commits to protect the workers, its visitors and the surrounding environment from
Standard 2. exposure to and/ or contamination by biological agents.
protects the biological agents from loss, theft, misuse, diversion of, unauthorized
access or intentional unauthorized release
The organization shall conduct a new risk assessment and review the existing risk
assessment in the event of the following:
the commencement of new work or changes to the programme of work, including
the introduction of new biological agents or alterations to work flow or volume
emerging and re-emerging, infectious agents, toxins, reagents or other dangerous
substances
introduction of new procedures and practices, modifications to standard operating
procedures
introduction of new equipment to the laboratory environment, repositioning of
equipments or use of an aging equipment, equipment commissioning and
Standard 3. decommissioning
new personnel and/or changes in staffing composition
advances in scientific understanding and technology
construction of new facility, relocation or renovation, facility commissioning and
decommissioning
a recent “near-miss” incident, accident, laboratory-acquired infection (LAI), theft,
or security violation
national or regional changes in disease status (endemicity of disease or disease
eradication)
national, regional or local changes in threat environment or security environment
new local or national regulations
The organization shall adopt the risk assessment template and matrix as prescribed by
Standard 4.
DOH (See Annex A and B).
The organization shall continually improve the effectiveness of the biorisk

Standard 5. management system through a minimum of annual review/revision of the existing risk
assessment and mitigation controls.
The organization shall communicate the results of the risk assessment, and mitigation
Standard 6.
controls identified to all stakeholders.
STANDARDS CHAPTER 1
Biorisk Management System
26
Leadership and Commitment
Management leadership and organizational commitment is essential to

developing and maintaining effective workplace health and safety management
systems. Ultimate accountability and responsibility for establishing and maintaining the
biorisk management system rests with the top management. The management must
demonstrate that the organization takes health and safety seriously. Strong leadership
and a firm commitment to continuously-improving health and safety performance,
backed by action, are the foundations of a strong health and safety culture.
Biorisk Officer
Medical laboratories are potentially dangerous places to work due to chemical,

electrical, mechanical, physical, and above all, biological hazards. As such, it is
important to always minimize every risk in the laboratory.
The first step in the safety improvement process is to appoint a Biorisk Officer. As
stated in the Department of Health (DOH) Administrative Order (AO) No. 2021-0037,
otherwise known as the new “Rules and Regulations Governing the Regulation of
Clinical Laboratories in the Philippines,” it is mandatory to designate a Biosafety and
Biosecurity Officer. This person is responsible for all the topics related to biosafety and
biosecurity. He/She has an advisory function in the laboratory management. Further, it
is important that the designated Biorisk Officer receives the full support from the
laboratory management and is fully-recognized by all the staff members. Likewise, the
full cooperation of all laboratory personnel is vital in the performance of duties of the
Biorisk Officer.
Biorisk Management Policy
It is imperative for management to establish and communicate institutional

expectations regarding safe and secure management of pathogens. These expectations
must be integrated with the core mission of the institution. The biorisk management
policy should reflect top management/leadership commitment to the biorisk
management system. This policy commits to:
●
27
● Protect staff, contractors, visitors, community and environment from biological
agents and toxins that are stored or handled within the laboratory;
● Reduce the risks to an acceptable level of unintentional release of, or exposure
to biological agents and toxins;
● Reduce the risks to an acceptable level of unauthorized intentional release of
hazardous biological materials, including the need to conduct risk assessments
and implement the required control measures;
● Comply with all requirements applicable to the biological agents and toxins that
will be handled or possessed;
● Effectively inform all employees and relevant stakeholders and communicating
individual obligations with regard to biorisk; and
● Continually improve biorisk management performance.
Roles and Responsibilities
The effective management of biological risks is supported by established

measures at both the national and institutional levels. Just as national governments and
authorities must assess biological risks and apply nationwide regulatory frameworks to
control them, organizations in which biological agents are handled have an obligation to
assess the biological risks that exist in their facility and apply appropriate risk control
measures to protect their personnel, community and the environment.
Although the responsibility for establishing and managing a biosafety program,

including defining and assigning roles and responsibilities, rests with the senior
management of an organization, all laboratory personnel, as well as support personnel,
who may come into contact with biological agents are responsible for actively
participating in the biosafety programme.
28
The management shall have the full responsibility of the biorisk management system:
Shall demonstrate its commitment through provision of appropriate and adequate
funds and other resources to establish, implement, maintain, and improve the
biorisk management system.
Responsible for setting the organization's policy for biosafety and biosecurity.
Ensure compliance with DOH issuances and legislations.
Standard 1. Shall identify and may delegate authority for the biorisk officer or the biorisk
committee, if applicable. And define the roles and responsibilities for biosafety of
all personnel within the organization. The management shall ensure completion of
relevant risk assessment.
Shall provide oversight of the biosafety programme.
establish Biorisk Committee and/or Institutional Biosafety and Biosecurity
Committee (IBBC), if applicable
The Organization shall have a designated Biorisk Officer as stipulated in the DOH AO
2021-0037 entitled “Rules and Regulations Governing the Regulation of Clinical
Laboratories in the Philippines.”
Qualifications:
Trained from DOH-accredited/recognized institution (based on the prescribed
curriculum) e.g. Research Institute for Tropical Medicine (RITM), National Training
Center for Biosafety and Biosecurity (NTCBB)
Roles and Responsibilities:

Standard 2.
Lead the conduct of Risk Assessment
Recommend policy or advice on biorisk management
Facilitate development of protocols and operating procedures
Recommend mitigation controls
Develop and/or deliver biorisk-related training activities;
Conduct of at least annual Internal review of performance;
Communicating with the management and personnel at all levels of the
organization about biorisk.
Submit reports (e.g. laboratory acquired infections/ incidents, near-miss, others
biorisk related reports) to DOH (See Annex D)
STANDARDS CHAPTER 2
Roles, Responsibilities and Authorities
29
High complexity facilities with multiple laboratories are encouraged to establish a
biorisk committee with the following functions (especially laboratories without ICC
accreditation or Safety Committee):
Provide advice to the development of institutional biorisk policies and codes of

practice;
Standard 3.
Approve proposals for new work or significant modifications to the potential risk
associated with existing activities;
Review protocols and risk assessments for work involving biological agents and
toxins;
Review information relating to significant accidents / incidents, data trends,
associated local / organizational actions and associated communication needs.
For institutions engaged in research work with highly hazardous biological agents and
products are required to establish an Institutional Biosafety and Biosecurity
Standard 4. Committee (IBBC), which will evaluate and monitor the biosafety and biosecurity
aspects of their biological research. This function can be delegated to the biorisk
committee.
Laboratory personnel shall support and contribute to a robust biosafety program by:
Adhering to institutional policies;
Completion of required training;
Standard 5. Following SOPs and other operational working practices; and
Reporting to the biosafety officer any contravention of these procedures and
practices, any areas for improvement, or any incidents with hazardous biological
materials.
Support personnel shall also support and contribute to a robust biosafety program
by:
Completion of training to understand and identify potential hazards
Standard 6.
Communicating identified hazards to the biosafety officer;
Applying work practices that prevent exposure to themselves or others; and
Following the security measures in place to limit laboratory access.
STANDARDS CHAPTER 2
Roles, Responsibilities and Authorities
30
Introduction
Laboratory biosafety activities are fundamental to protecting the laboratory

workforce and the wider community against unintentional exposures or releases of
pathogenic biological agents. Biosafety describes the use of specific practices, training,
safety equipment, and specially designed buildings to protect the worker, community,
and environment from such exposure.
With adherence to the recommendations of the World Health Organization

(WHO), as issued in its Laboratory Biosafety Manual 4th Edition, laboratory biosafety
requirements have been categorized into Core, Heightened and Maximum
Requirements. Core Requirements are a combination of risk control measures that are
both the foundation for, and an integral part of, laboratory biosafety. These are the
minimum basic requirements for laboratory biosafety. The Heightened Requirements
are a set of risk control measures that may need to be applied in a laboratory facility
because the outcome of a risk assessment indicates that the biological agents being
handled and/or the activities to be performed with them are associated with a risk that
cannot be brought to an acceptable risk with the core requirements only. The Maximum
Requirements employs maximum containment measures to control very high risks to
personnel and the community. Such a facility will only be required where biological
agents with the very highest consequences are used in work that has a high likelihood
of exposure. This includes work with biological agents that pose a severe health risk to
personnel or the community if released
Good Microbiological Practice and Procedure
Good Microbiological Practice and Procedure (GMPP) is a term given for

standard operating practices and procedures or a code of practice when working with
biological agents. GMPP are essential in the control of laboratory-acquired infections,
which includes best practices or behaviors to be followed to ensure a safe work
environment, technical procedures to consider for controlling the risk of exposure and
cross-contaminations.
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Personnel Competence And Training
This enforces the importance of proper staff training, including a table outlining
the training that should be implemented for laboratory personnel. Human error and poor
technical skills can compromise the best safeguards. Thus, competent and
safety-conscious laboratory personnel, who are well informed on how to recognize and
control laboratory risks, are essential for the prevention of laboratory-associated
infections and/or other incidents.
Facility Design
Laboratory design requirements are vital for safe work and handling of biological
agents. These include the type of finishing the laboratory should have for floor, walls,
cabinets, work surface, as well as storage needed for supplies and samples, lighting
and ventilation requirements, reliable electricity sources and emergency equipment for
external threats from weather, geographical elements, fire, floods, etc.
Specimen Receipt And Storage
Minimizing risks when receiving, storing, and inactivating specimens plays a vital
role to prevent exposure of both the personnel and the community to the biological
hazards. This includes requirements that should be considered when receiving
specimens, such as documentation for the laboratory personnel to be able to identify
the specimens that are potential hazards, storage of specimens, such as specifications
of storage containers, and having validated inactivation procedures before transferring
samples to other areas for manipulation.
Decontamination and Waste Management
Biosafety management programs should include processes for identification,

segregation of contaminated material prior to decontamination/disposal. Any surface or
material could potentially be contaminated by biological agents during laboratory
operations and must be correctly managed to control biological risks.
32
Where decontamination cannot be performed in the laboratory area or onsite, the
contaminated waste must be packaged in an approved manner for transfer to another
facility with decontamination capacity.
Laboratories must also have procedures of decontamination methods and

consideration needs for non-biological material that may be contaminated such as work
surfaces, sharps which includes chemical disinfection, autoclaving, incineration, etc.
Personal Protective Equipment
Personal Protective Equipment (PPE) refers to a set of wearable equipment

and/or clothing worn (for example, gloves) by personnel to provide an additional barrier
between them and the biological agents being handled, which effectively controls risk by
reducing the likelihood of exposure to the agents.
Any PPE used in the laboratory must be correctly fitted, and personnel must be
given adequate training in order to ensure it is used properly and effectively. Incorrect
use of PPE, for example, unfastened laboratory coats, will not give the protection they
are designed to provide. When combinations of PPE are worn together, they must
complement one another and continue to fit properly.
Laboratory Equipment
The safe use of laboratory equipment will help minimize the likelihood of
exposure of personnel when handling or manipulating biological agents. For equipment
to effectively reduce risks, laboratory management must make sure sufficient space is
provided for its use. An appropriate budget must be available for the equipment’s
operation and maintenance, including equipment incorporated into the facility design,
which should be accompanied by specifications that outline its safety features.
Selected equipment must be designed, constructed and installed so that it

facilitates simple operation and allows for maintenance, cleaning, decontamination and
certification to be performed in a way that contact between the operators and biological
agents is prevented or limited wherever possible.
33
Emergency/Incident Response
To reduce the likelihood of exposure to/release of a biological agent or to reduce

the consequences of such incidents, a contingency plan must be developed that
provides specific SOPs to be followed in possible emergency scenarios that apply to the
work and local environment. Personnel must be trained on these procedures and have
periodic refresher training in order to maintain competency. Emergencies can include
those related to chemical incidents, fire, electrical breakdown, radiation incidents, pest
infestation, flooding, or personal health issues of personnel. First-aid kits, including
medical supplies such as bottled eye washes and bandages, must be available and
easily accessible to personnel. These must be checked routinely to make sure products
are within their use-by dates and are in sufficient supply.
All incidents must be reported to the appropriate personnel, usually a laboratory

supervisor, in a timely manner. A written record of accidents and incidents must be
maintained. Any incident that occurs must be reported and investigated in a timely
manner. Results from incident investigations must be used to update laboratory
procedures and emergency response.
Transfer And Transportation Of Infectious Substances, Biological Specimens
It is often necessary to transport specimens, biological materials or waste that

are known or expected to contain biological agents between rooms, laboratories or
facilities. In some cases, the material may need to be transported to laboratories in
other cities, regions or even countries for further testing, treatment or storage.
Transportation of infectious substances may be subject to various national and/or

international regulations, depending on the origin, destination and/or the mode of
transport being used. Irrespective of the regulations that apply, the aim is always to
reduce the likelihood of an exposure to and/or a release of the infectious substance in
order to protect personnel, the community and/or the surrounding environment.
34
Occupational Health
The employing authority, through the laboratory director, must take responsibility
for ensuring that the health of laboratory personnel is adequately checked and reported.
The objective is to provide a safe working environment including preventative measures
(for example, vaccination) and monitoring of employee health to enable appropriate
measures to be taken in case of exposure or occupation-related disease or any other
aspect of the work that affects the safety, health and well-being of employees.
35
The organization shall comply with the core requirements.
Standard 1. (Refer to Annex C for detailed discussion on Laboratory Biosafety Core
Requirements)
Local risk assessment shall be conducted to determine if core requirements

Standard 2
are sufficient or additional mitigations are required.
The organization shall comply with DOH issuances relating to biorisk

Standard 3.
management.
STANDARDS CHAPTER 3
Biosafety
36
Introduction
Biosecurity is one of the components of biorisk management, which ensures the

safe use and security of biological materials in laboratories. Biosecurity focuses on
protecting biological agents from theft, loss, or misuse.
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 intentional release.
Biosecurity Awareness
Which hazards are associated with activities involving high-risk pathogens? Are
employees at all levels of the organization aware of these risks and of the measures
that can be taken? What is the status of the security culture within your organization?
Employees who are aware of the biosecurity risks will act accordingly. To ensure the
success of both biosafety policy and biosecurity policy, various officers and
professionals in the organization should be involved. Employee awareness of
biosecurity throughout the organization is essential to identify abnormal situations in the
workplace that may pose a threat to the organization or society. If employees
understand the hazards, they act accordingly and therefore pay attention to abnormal
situations.
Personnel Reliability
One of the fundamental aspects of biosecurity management is personnel

management. This ensures that daily work and procedures are being performed by
appropriate personnel who behave in a reliable and trustworthy manner. Personnel
management aims to keep biological agents and toxins out of the possession of
individuals who might intend to misuse them. Personnel are required to be screened
prior to being granted access to the laboratory. Employee screening policies and
procedures are used to help evaluate these individuals. Policies should also include
personnel and visitor identification, visitor management, access procedures, and
reporting of security incidents.
37
Information Security
Information security or data security is another component of a laboratory

biosecurity plan. The objective of an information security program is to protect
information from unauthorized release and ensure that the appropriate level of
confidentiality is preserved. Information, like physical property, is considered to be
critical infrastructure and must be properly protected and secured hence people at all
levels within an organization have a role in managing information security risks. Loss of
data and computer systems from sabotage, viruses, or other means can be devastating
for a laboratory.
Material Control and Accountability
Material Control and Accountability is the assurance that there is an awareness

of what exists in the laboratory, where it is, and who is responsible for it. Material
accountability procedures should be established to track the inventory, storage, use,
transfer and destruction of dangerous biological materials and assets when no longer
needed. The objective is to know what agents exist at a facility, where they are located,
and who is responsible for them. Depending on the risks associated with a pathogen or
toxin, management can designate an individual who is accountable, knowledgeable
about the materials in use, and responsible for security of the materials under his or her
control.
Even the most well-prepared laboratory may experience unintentional or

intentional incidents or emergencies such as discrepancies found in inventories, missing
biological agents or unauthorized persons in the laboratory despite existing prevention
or risk control measures. Response plans, crisis response plans, contingency plans,
business continuity plans; the name does not matter as long as an organization is
prepared for emergency situations. After an incident or calamity, adequate measures
must be taken to limit the damage and to restore operations as soon as possible.
38
Management
Biosecurity should be an integral part of program management of organizations

handling dangerous pathogens, in order to prevent potential dual-use research,
undesired spread, theft, malicious use, and bioterrorism. The management must
demonstrate that the organization takes health and safety seriously through
establishment of a biosecurity management system, biosecurity policy and procedures
and provision of budget and resources.
Physical Security
Physical Security is one of the aspects of biosecurity intended to prevent the

misuse, loss, or theft of biological agents and toxins. Physical security encompasses
measures to safeguard and prevent non-official access to these biological assets in the
laboratory.
An important concept in Physical Security is the concept of Graded Protection.

This is based on the idea that different areas of a facility will have different levels of
security based on risk spanning from outside to inside the facility.
Access Control is another important aspect of biosecurity. It is the mechanism to

determine and control authorized entry into secured areas. Access Control also
provides capability to delay or deny unauthorized personnel.
Transport Security
Transport Security is the assurance that the same rigorous processes that
protect biological materials in the laboratory follow those materials when they are
transported outside laboratory areas. This aims to reduce the risk of illicit acquisition of
high-risk biological agents and relies on chain of custody principles and end user
agreements.
39
Biosecurity Awareness
Standard 1.
All laboratory personnel shall have appropriate biosecurity training.
Personnel Reliability
The organization shall have an established specification for assessing
Standard 2.
suitability for employees, visitors and support personnel before granting
authorized access.
Information Security
The organization shall have processes and procedures to protect the
Standard 3.
confidentiality and integrity of sensitive information held in the laboratory and
to prevent data breaches.
Material Control and Accountability

Standard 4. There shall be a documented tracking and inventory of specimens/ biological
materials from receipt to disposal.
The organization shall incorporate biosecurity response to its general
Standard 5.
emergency and incident response. (e.g. theft, misuse, unauthorized
access/use, missing specimens/biological assets, loss, intentional release)
Management
Standard 6. The laboratory management shall provide biosecurity policy, plan and
procedures.
Physical Security
The organization shall have system/s to control/limit access of unauthorized
personnel (e.g. lock and keys, CCTV, security guard)
Standard 7. The organization shall ensure that biological assets are stored in a secured
location.
The organization shall have system/s to monitor transactions/activities of
authorized personnel.
Transport Security
Standard 8. There shall be a documented chain of custody of all specimens/biological
agents for transport.
STANDARDS CHAPTER 4
Biosecurity
40
(NAME OF LABORATORY) RISK ASSESSMENT C.Y ____
Existing
Additional
Section Aspect Risk Hazard/Threat Situation Mitigation Likelihood Consequence Risk Evaluation Acceptance
Control
Reassessment
Control
Sample collection
Sample shipping and
transportation
Sample receipt
Microbiology Temporary sample storage

Sample processing
Data analysis
Results release
Waste treatment and disposal
41
Likelihood / Probability
Level Descriptor Example (ISO 14971) Practical Example
1 Rare < 1/1,000,000 but ≥ 1/10,000,000 Unlikely to ever happen
2 Unlikely ≤ 1/100,000 but ≥ 1/1,000,000 Once every few years
3 Possible ≤ 1/10,000 but ≥ 1/100,000 Once a year
4 Likely ≤ 1/1,000 but ≥ 1/10,000 Once every few months
5 Almost Certain ≥ 1/1,000 More than 1x/week
Consequences / Impact
Level Descriptor Likelihood Description
1 Negligible Inconvenience or temporary discomfort
Results in temporary injury or impairment not requiring professional

2 Minor
medical intervention
Results in injury or impairment requiring professional medical
3 Moderate
intervention
4 Major Results in permanent injury of life-threatening injury
5 Severe Results in patients death
42
43
GOOD MICROBIOLOGICAL PRACTICE AND PROCEDURE
CORE: HEIGHTENED: MAXIMUM:
● Never store food or drink, or personal ● Associated protocols developed to restrict ● A complete change of clothing and shoes
items in the laboratory workplace. Activities access to only trained individuals and/or is required before entering and on leaving
such as eating, drinking, smoking, and specified personnel in that area. the laboratory.
applying cosmetics are only to be ● Special entry conditions can be applied for ● The operator usually enters the laboratory
performed outside the laboratory. some personnel which are a prerequisite through a chemical shower cubicle, which
● Never put materials, such as pens, pencils for entering the laboratory, for example, will serve to decontaminate the operator's
or gum, in the mouth while inside the specific immunizations. suit upon exit.
laboratory, regardless of whether gloves ● Open manipulations of biological agents ● Personnel must be trained in emergency
are worn or not. may need to be conducted using a primary extraction procedures in the event of
● Wash hands thoroughly after handling containment device such a BSC, and/or personnel injury or illness.
biological material before leaving the respiratory protection may need to be ● Working alone is not permitted.
laboratory or when hands are known or used. ● A method of communication for routine and
believed to be contaminated. emergency contacts must be established
● Ensure open flames or heat sources are between personnel working in the
never placed near flammable supplies and maximum containment measures
are never left unattended. laboratory and support personnel outside
● Ensure that cuts or broken skin are the laboratory.
covered before entering the laboratory. ● A method to visually monitor and record
● Before entering the laboratory, ensure that the activities of personnel working inside
there are adequate supplies of laboratory the laboratory must be implemented.
equipment and consumables, including
reagents, PPE and disinfectants, and that
these items are suitable for the activities
envisaged.
● Ensure that supplies are stored safely and
according to storage instructions to reduce
accidents and incidents such as spills, trips
and falls.
44
● Ensure proper labeling of all biological
agents as well as chemical and radioactive
material.
● Protect written documents from
contamination using barriers (such as
plastic coverings), particularly those that
may need to be removed from the
laboratory.
● Ensure that the work is performed with
care and without hurrying.
● Keep the work area tidy, clean and free of
non-essential objects and materials.
● Cover or remove any jewelry that could
tear gloves, easily become contaminated
or become fomites. Cleaning and
decontamination of jewelry or spectacles
should be considered, if such items are
worn regularly.
● Refrain from using portable electronic
devices when not specifically required for
the laboratory procedures being
performed. Keep portable electronic
devices in areas where they cannot easily
become contaminated or act as fomites
that transmit infection. Where close
proximity of such devices to biological
agents is unavoidable, ensure the devices
are either protected by a physical barrier or
decontaminated before leaving the
laboratory.
● Use techniques to minimize the formation
of aerosols and droplets when
manipulating specimens to avoid inhalation
of biological agent
● Avoid ingestion of biological agents and
contact with skin and eyes
● Wear disposable gloves at all times when
handling specimens known or reasonably
expected to contain biological agents.
Disposable gloves must not be reused.
● Avoid contact of gloved hands with the
face.
45
● Remove gloves aseptically after use and
wash hands
● Shield or otherwise protect the mouth,
eyes and face during any operation where
splashes may occur, such as during the
mixing of disinfectant solutions.
● Cover any broken skin with a suitable
dressing.
● Prohibit pipetting by mouth.
● Never use syringes with needles as an
alternative to pipetting devices.
● Dispose of any sharps materials (for
example, needles, needles combined with
syringes, blades, broken glass) in
puncture-proof or puncture-resistant
containers fitted with sealed covers.
Disposal containers must be
puncture-proof/-resistant, must not be filled
to capacity (three-quarters full at most),
must be never reused and must not be
discarded in landfills.
● Place waste containers, preferably
unbreakable (such as plastic, metal), at
every workstation.
● Regularly empty waste containers and
securely dispose of waste.
● Ensure all waste is properly labeled.
● Decontaminate work surfaces with a
suitable disinfectant at the end of the work
procedures and if any material is spilled.
● When disinfectants are used, ensure the
disinfectant is active against the agents
being handled and is left in contact with
waste materials for the appropriate time,
according to the disinfectant being used.
46
PERSONNEL COMPETENCE AND TRAINING
● General familiarization and awareness ● Additional training will be required for any ● Specialist laboratory personnel should be
training procedures, biological agents, systems or allowed to work with maximum
○ Laboratory layout, features and equipment that require heightened control containment measures. Personnel must
equipment measures. have an appropriate level of laboratory
○ Laboratory code(s) of practice ○ competency in the related protocol experience, and a specialized, in-depth,
○ Safety or operations manual(s) ○ emergency operations should an pre-service training programme must be in
○ Institutional policies incident occur, or the risk control place.
○ Local and overarching risk measure fails. ● Strict supervision and mentoring must be
assessments ● A prescribed period of mentorship is observed until new personnel are
○ Emergency/incident response recommended until personnel are considered suitably competent, or existing
procedures considered competent. personnel considered appropriately
● Job-specific training ● Competence in the relevant procedure proficient in any new processes and
● Training mandated by law must be assessed and documented before procedures introduced.
● Safety and security training unsupervised work proceeds ● Training should include scenario-based
○ Awareness of hazards present in ● Competency must be regularly reviewed to emergency response and periodic
the laboratory and their associated ensure best practices are maintained. refresher training.
risks
○ Safe working procedures
○ Security measures
○ Emergency preparedness and
response
47
FACILITY DESIGN
● Ample space must be provided for the safe ● Designated hand-washing basins operated ● Design features of a laboratory using
conduct of laboratory work and for cleaning by a hands-free mechanism must be maximum containment measures include
and maintenance. provided in each laboratory room, an efficient primary containment system,
● The laboratory must be a restricted-access preferably close to the exit door. specific entry and access features and a
area. ● Laboratory entrance doors to have vision dedicated heating, ventilation and air
● Doors must be appropriately labeled with panels (to avoid accidents during opening), conditioning system.
the international biohazard warning appropriate fire ratings and preferably be ○ a completely closed cabinet barrier
symbols wherever biohazardous materials self-closing. system working under negative
are handled and stored. ● The management of waste must be pressure that isolates the
● Laboratory walls, floors and furniture must considered in the design. Safety systems biological material from the
be smooth, easy to clean, impermeable to must surrounding laboratory
liquids and resistant to the chemicals and ● cover fire, electrical emergencies and environment.
disinfectants normally used in the emergency/incident response facilities ○ Cabinet/isolator is equipped with
laboratory. based filters for inlet and exhaust air,
● Laboratory bench tops must be impervious ● on risk assessment. entry ports such as double-door
to water and resistant to disinfectants, ● Physically separating the laboratory autoclave, fumigation chambers,
acids, alkalis, organic solvents and room/spaces from areas open to and/or dunk tanks.
moderate heat. unrestricted traffic flow within the building, ○ Dedicated, room air supply and
● Laboratory furniture must be fit for thus reducing the risk of exposure to exhaust systems must be in place
purpose. Open spaces between and under passing individuals not directly involved in and constantly monitored by a
benches, cabinets and equipment must be the laboratory work. building management system or
accessible for cleaning. ● In some cases a separate building will be equivalent.
● Laboratory lighting must be adequate for part of heightened control measures. ○ Exhaust air from the Class III BSC
all activities. Daylight should be utilized ● Where gaseous disinfection is selected as or negative-pressure isolator must
effectively to save energy. Undesirable a heightened control measure for be passed through two
reflections and glare should be avoided. decontamination and waste management, independent HEPA filters in series
Emergency lighting must be sufficient to laboratory room/space airtightness will before release outdoors. The
permit safe stopping of work as well as need to be enhanced. This is achieved by second filter can therefore act as a
safe exit from the laboratory. sealing all surfaces and/or laboratory back-up in case the primary filter
● Laboratory storage space must be penetrations to prevent the escape of fails.
adequate to hold supplies for immediate hazardous gases. ○ The cabinet or isolator must be
use to prevent clutter on bench tops and in ● Exhaust air must be filtered before operated at negative pressure to
aisles. Additional long-term storage space, exhausting. the surrounding laboratory at all
conveniently located outside of the ● Installing space for the onsite treatment of times. Appropriate alarms should
laboratory room/space, should be laboratory waste, or by providing dedicated inform the laboratory personnel in
considered. secure storage for laboratory waste until it case of system failures.
● Space and facilities must be provided for can be transported off-site for ○ Emergency power and dedicated
the safe handling and storage of chemicals decontamination. power supply lines must be
provided for all critical safety
48
and solvents, radioactive materials, and equipment that needs to continue
compressed and liquefied gases if used. to work to maintain safety.
● Facilities for storing food and drink, ● It is also recommended that a laboratory
personal items, jackets and outerwear using maximum containment measures be
must be provided outside the laboratory. located in a separate building or, as a
● First-aid facilities must be readily minimum, in a clearly delineated zone
accessible and suitably equipped/stocked. within a secure building.
● Appropriate methods for decontamination,
for example, disinfectants and
autoclaves must be available in proximity
to the laboratory.
49
SPECIMEN RECEIPT AND STORAGE
● Personnel unpacking and receiving ● Opening specimens from their transfer or ● Specimens leaving or arriving at the facility
specimens must be adequately trained in: transport containers within a primary must be transported according to national
○ awareness of the hazards containment device and/or while wearing and international regulations.
involved, additional PPE. ● Upon receipt, specimens must only be
○ how to adopt necessary ● Applying more stringent restricted-access opened and handled within the laboratory
precautions according to GMPP protocols to storage areas. by specially trained personnel.
described above ● Specimens must be stored securely in
○ how to handle broken or leaking dedicated refrigerators, freezers and liquid
containers to prevent exposure to nitrogen storage, which can only be
biological agents accessed by authorized personnel.
○ how to handle spills and use ● A strict inventory of stocks and specimen
disinfectants to manage any movement must be kept.
contamination.
● Specimens must be stored in containers
that are:
○ made of adequate strength,
integrity and volume to contain the
specimen,
○ leak-proof when the cap or stopper
is correctly applied
○ preferably made of plastic
○ free of any biological material on
the outside of the packaging,
○ correctly labeled, marked and
recorded to facilitate identification,
and made of an appropriate
material for the type of storage
required.
50
DECONTAMINATION AND WASTE MANAGEMENT
● Where decontamination cannot be ● Waste generated by procedures using ● All waste leaving the laboratory must be
performed in the laboratory area or onsite, heightened control measures should treated so that it is thoroughly
the contaminated waste must be packaged preferably be decontaminated onsite, or decontaminated and presents no infectious
in an approved leak-proof manner for close to the laboratory, to minimize the risk threat.
transfer to another facility with of exposure or release during waste ● Methods for disinfection and
decontamination capacity transportation. decontamination of material leaving the
● Laboratory waste materials and their ● Where onsite decontamination is not laboratory must be validated each time
recommended treatment possible, solid waste must be appropriately they are used to verify their effectiveness.
○ Uncontaminated non-infectious packaged, stored (if required) and ● All effluents from the suit area,
material - Can be reused or transferred as soon as possible to another decontamination chamber, suit shower and
recycled or disposed of as general facility with decontamination capabilities. cabinet line (BSCs or isolators) must be
municipal waste decontaminated before final discharge
○ Contaminated sharps using either heat or chemical treatment.
(hypodermic needles,scalpels, ● A double-door, pass-through autoclave
knives and broken glass) - Must must be available in the laboratory area.
be collected in puncture-proof ● Containment drains should only be
containers fitted with covers and installed if shown to be required by the risk
treated as infectious assessment
○ Contaminated material for reuse
or recycling - Must be first
decontaminated (chemically or
physically) and then washed;
thereafter it can be treated as
uncontaminated (noninfectious)
material
○ Contaminated material for
disposal - Must be
decontaminated onsite OR stored
safely before transportation to
another site for decontamination
and disposal
○ Contaminated material for
incineration - Must be incinerated
onsite OR stored safely before
transportation to another site for
incineration
○ Liquid waste (including
potentially contaminated
liquids) for disposal in the
51
sanitary sewer system - Should
be decontaminated before disposal
in the sanitary sewer
● The treatment of the segregated waste will
depend on the type of material, the
biological agent/s being handled, locally
available decontamination methods and
locally available protocols for
decontamination.
52
PERSONAL PROTECTIVE EQUIPMENT
● Laboratory coats must be used in ● Safety glasses, safety goggles, face ● Suit must be designed to withstand contact
laboratories to prevent personal clothing shields (visors) or other protective devices with the equipment, chemicals and other
from getting splashed or contaminated by must be worn whenever it is necessary to materials used in the suit laboratory, and to
biological agents. Laboratory coats must protect the eyes and face from splashes, allow tasks
have long sleeves, preferably with fitted impacting objects and artificial ultraviolet ● Detailed SOPs should be developed on
cuffs, and must be worn closed. Sleeves radiation. safe use of the suit, with personnel
should never be rolled up. Coats must be ● Personal prescription glasses (spectacles) receiving practice and training on how to
long enough to cover the knees, but not must not be used as a form of eye implement the SOPs correctly.
trail on the floor. protection as they do not cover enough of ● An effective maintenance system needs to
● Laboratory coats must only be worn in the face around the eyes be in place that covers cleaning,
designated areas. When not in use, they ● Respiratory protection is generally not disinfection, examination, replacement,
should be stored appropriately; they should required for protection against biological repair and testing of the suit.
not be hung on top of other laboratory agents as a part of the core requirements.
coats, Where a risk assessment indicates that the
● Appropriate footwear must be worn in the use of respiratory protection is needed, this
laboratory and must be of a design that is considered a heightened control
minimizes slips and trips and can reduce measure.
the likelihood of injury from falling objects ○ Its level of protection must be
and exposure to biological agents. appropriate for the risks identified
● Appropriate disposable gloves must be and its use must adequately
worn for all procedures that may involve reduce exposure to the level
planned or inadvertent contact with blood, required to protect the wearer’s
body fluids and other potentially infectious health.
materials. ○ It must be worn correctly and
● Different types of gloves may be needed according to the manufacturer’s
for different applications or other instructions.
occupational hazards, such as thermal ○ It must fit and be suitable for the
protection, or protection from sharps or person wearing it.
against chemicals. ○ When reusable respiratory
● Various sizes should be available to ensure protective equipment is used, it
that gloves properly fit the user to allow must be appropriately
adequate movement and dexterity for the decontaminated after use, and
procedures being performed. properly stored and maintained.
○ It must complement any other PPE
being worn. This is especially
important in the use of eye
protection.
53
● Laboratory coats that overlap at the front
can be worn to provide extra protection
against splashes and spills.
● An additional fluid-resistant apron,
laboratory coat and/or disposable sleeves
can be worn for procedures where the
possibility of large splashes cannot be
discounted.
● Reusable items can undergo an
appropriate decontamination procedure
(such as autoclaving) before laundering.
● Scrubs or other dedicated laboratory
protective clothing can be worn to prevent
contamination of personal clothing.
● Footwear may need to be changed and/or
covered before entry into the laboratory if
there is a requirement to prevent cross
contamination.
● Additional gloves (for example, double
gloving, insulated gloves, bite-resistant
gloves or chemical-resistant gloves) may
be required for some activities.
54
LABORATORY EQUIPMENT
● Records must be kept detailing equipment ● Applying additional containment ● Only dedicated laboratory equipment
use, any maintenance performed, and any accessories to current equipment, for should be used for the high-risk tasks
validation/calibration procedures example, safety buckets or containment requiring maximum containment measures.
undertaken and their results. rotors in centrifuges ● The equipment must be able to withstand
● Training and proficiency of personnel ● Dedicating current equipment for use only fumigation or be able to be wrapped or
authorized for equipment use. for the higher-risk tasks to avoid cross moved to a gas-tight, fumigation-free zone
● Equipment must be constructed of contamination within the laboratory during routine
materials that are impermeable to liquids laboratory fumigation.
(including chemicals used for
decontamination), resistant to corrosion
and that meet the structural requirements
of the required tasks.
● Any equipment failures must be reported
immediately and corrective actions taken to
rectify them before the equipment is used
again.
55
EMERGENCY/INCIDENT RESPONSE
● A contingency plan must be developed that ● An emergency shower to be used to help ● An emergency programme must be
provides specific SOPs to be followed in disinfect personnel who may have been devised. National and local health
possible emergency scenarios that apply to exposed to a large volume of biological authorities should actively cooperate in
the work and local environment. agents. preparing this programme.
Emergencies include man- ● Approaches include a buddy system or
● Personnel must be trained on these special devices that can be used to alert
procedures and have periodic refresher specified personnel (such as security) if the
training in order to maintain competency. device detects that the operator has fallen
● First Aid kits must be available and easily or remained motionless for a set period of
accessible to personnel. time.
● All incidents must be reported to the
appropriate personnel, usually a laboratory
supervisor, in a timely manner.
● A written record of accidents and incidents
must be maintained.
● Any incident that occurs must be reported
and investigated in a timely manner.
Results from incident investigations must
be used to update laboratory procedures
and emergency response.
● Spill kits, including disinfectant, must be
easily accessible to personnel. Personnel
should be trained.
● Planning for and sourcing of post-exposure
prophylaxis and therapeutics that may be
necessary.
56
TRANSFER AND TRANSPORTATION OF INFECTIOUS SUBSTANCES, BIOLOGICAL SPECIMENS
CORE:
Within the Laboratory:

● Use sealed containers, such as
screw-capped tubes. Snap-cap lids should
be avoided as they are less secure.
● Use deep-sided and leak-proof trays or
boxes made of smooth impervious material
(for example, plastic or metal), which can
be effectively cleaned and disinfected.
● Make sure spill kits are readily available for
use in the event of a spillage during
transfer, and available personnel are
trained in their use.
Within a Building:
● Must be carried out in a way that minimizes
transit through communal areas and public
thoroughfares.
● Transfer containers must be suitably
labeled to identify their contents, and
surfaces decontaminated before leaving
the laboratory.
Between buildings on the same site:

● Sealable plastic bags, plastic screw-top
tubes and locking plastic containers can all
be used in the transfer of infectious
substances between buildings.
● Absorbent materials should be used
between layers of packaging to absorb all
infectious substances, if there were
leakage.
● The outermost transport container should
be rigid. It can vary widely depending on
the resources available. A plastic box or
small plastic ice chest are options.
● Personnel involved in the transfer must be
provided with suitable awareness training
on the risks present during the transfer
process and how to safely reduce them.
57
● Spill kits must be readily available and
appropriate personnel trained in their use.
● Recipients must be notified in advance of
the transfer occurring.
Off-site transport
● National and international transport
regulations must be followed to regulate
packaging, labeling, marking and
documentation of infectious substances to
minimize the likelihood of exposure and/or
release during transit. (please refer to DOH
Manual on Packaging and Transport of
Laboratory Specimens for Referral)
58
OCCUPATIONAL HEALTH
● Medical examination or health status ● A detailed medical history and an ● A system must be in place to provide
information of laboratory personnel is occupationally-targeted examination is 24-hour help in case of an emergency.
required to ensure that it is safe for them to required.
work in the laboratory. ● Working policies should ensure that the
● All aspects of an employee’s health status number of hours worked in the laboratory
must be kept confidential. on a single occasion is kept to a minimum
● Incidents of injuries and confirmed to prevent physical and/or mental fatigue.
exposure must be reported immediately
and appropriate first aid and/or prophylaxis
precautions must be given. (See Annex D)
59
Accident/Incident Investigation Report

Laboratory Personnel 󠄂
Patients 󠄂
Guests
Others: Please specify ___________________
Classification of Incident/Accident:
Major Accident
Multiple Injury Accident
First Aid Only
Non-Injury/Illness
PART I. Personal Identification
Name: (Last, First Middle Name, Suffix) Age/Gender Part of the body affected (Shade all that apply)
Present Address: Anterior
Permanent Address:
Name of Company: Designation:
Contact No:
For Laboratory Personnel
Section/Unit/Department: Length of Service:
Immediate Superior’s Name: Designation: Contact Number:

Posterior
Property Damage
Object/Equipment/Material Involved:
Extent of Property Damage:

Minor Damage (i.e. Scratches, marks,
exterior disfigurement)
Major Damage (e.g. will temporarily cause
interruption of service
Total Breakdown/Damage (e.g. will cause
permanent non-usage of machine)
Estimated Cost:
60
PART II. Incident/Accident Description
Date/Time of Incident: Date/Time of Incident Reported: Exact Location of Incident:
BRIEF DESCRIPTION OF INCIDENT/ACCIDENT
Type of Accident Nature of Injury Injured Part of the Body

(Check all that apply)
Fall on the same level Amputation Head

Fall to below Dislocation Face
Struck by Sprain/Strain Eye
Struck against Foreign Body Mouth Nose
Caught in Abrasion/scrapes Ear
Caught on Laceration Abdomen
Caught between Inhalation/Congestion Back
Needle Stick Puncture Hip
Over Exertion (Overload) Scald/Burn Arm
Contact with Contusion/ Bruise Neck
Sharp Objects Crush/ Compression Thigh
Electricity Concussion Feet
Heat Others: ____________________ Hand
Cold Finger
Radiation Chest
Caustic Knee/s
Noise Buttocks
Toxic or noxious substance Others: ________________
Others: __________________
Medical Evaluation Severity of Harm Likelihood of Occurrence

(Refer to Risk Assessment Matrix for Descriptor) (Refer to Risk Assessment Matrix for Descriptor)
First Aid / Clinic Negligible Rare

Emergency Treatment Minor Unlikely
Needs Confinement Moderate Possible
Needs Surgery Major Likely
Severe Almost Certain
PART III. Possible Causal Factor
Basic Cause/s - Origin Immediate Causes/s - Symtoms
Personal Factor Unsafe Act Unsafe Condition

Lack of Knowledge or Skill Operating without authority Inadequate guards or protection
Improper Motivation Failure to warn or secure Defective tools, equipments and
Physical or Mental Problems Operating at improper speed substances
Making safety devices inoperable Congestion
Job Factor Inadequate warning system
Using defective equipment
Inadequate work standards Fire and explosion hazard
Using equipment improperly
Inadequate design or maintenance Substandard housekeeping
Failure to use PPE’s
Inadequate purchasing standards Hazardous atmospheric conditions
Improper loading or placement
Normal wear and tear Excessive noise
Improper lifting
Abnormal usage
61
Taking improper position Radiation exposure
Servicing equipment in motion Inadequate illumination or
Others: ___________________ ventilation
Workstation set-up
Others: __________________
PART IV. Medical Information
Date and Time admitted/consulted at Clinic / Hospital:
Name and Location of Clinic / Hospital:
Physician’s Findings:
Treatment Given:
Recommendations: (Please attach medical certificate)

Back to work
Give lighter work
Rest at home
Hospital confinement
Others: ________________________________________________
PART V. Planned Follow-up Efforts
How can similar incidents be prevented?

Stop the activity
Redesign task steps
Routine inspection of hazard
Guard the hazard
Redesign work station
Train the employee/s
Write new policy/rule
Train supervisors
Enforce existing policy
Personal protective equipment
Others: ______________________________________________
Follow up Action: (Please indicate mitigation applied and date of accomplishment)
PART VI. Risk Control Measure
Trivial Risk
Moderate Risk
Tolerable Risk
Substantial Risk
Intolerable Risk
Prepared by: Noted by:
Signature over Printed Name/Date Signature over Printed Name/Date
62
1. Biosafety Programme Management (World Health Organization)
Laboratory biosafety manual, fourth edition and associated monographs (electronic version) with
ISBN 978-92-4-001143-4
2. CEN Workshop Agreement (European Committee For Standardization)

Documented Laboratory biorisk management dated September 2011
(https://internationalbiosafety.org/wp-content/uploads/2019/08/CWA-15793-English.pdf)
3. Biosecurity Toolkits (Resource Repository - United Nations Office for Disarmament Affairs)
Found in the Website of the Dutch Biosecurity Office: (https://www.biosecurityselfscan.nl/home)
4. Philippine National Standard PNS ISO 35001:2020 Biorisk Management for Laboratories and
Other Related Organizations
5. Centers for Disease Control and Prevention: Biosafety in Microbiological and Biomedical
Laboratories (BMBL) 6th Edition
6. The Global Biorisk Management Curriculum
63
TO GOD BE ALL THE GLORY...
2023

Laboratory Biosafety and Biosecurity Standards Manual

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Laboratory Biosafety and Biosecurity Standards Manual

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2023

©2023 by the Department of Health. All rights reserved.

National Library Cataloging-in-Publication Data

Published by Department of Health

Development of this Manual was initiated and completed, and

As one Department of Health, I express my warmest congratulations

Greetings and salutations from the Health Systems

The Department of Health plays a vital role in ensuring

DR. LILIBETH C. DAVID, MPH, MPM, CESO I

On behalf of the Health Facility and Patient Support Team of

As the principal health agency in the Philippines responsible

On behalf of the Office for Health Laboratories of the

In the recent Covid-19 pandemic, one of the impediments

Health workers and Health Facility/Hospital Administrators have been continuously

Other health laboratories (i.e. Analytical Toxicology Laboratories, Drug Testing

Biosafety and biosecurity refer to a nation’s ability to respond effectively

TECHNICAL WORKING GROUP

Dr. Valerie Anne Tesoro Chairperson Office for Health Laboratories

Dr. Vita B. Gasataya Member South Cotabato Provincial Hospital

Mr. Plebeian B. Medina Member Research Institute of Tropical Medicine

Mr. Edsel Allan Salonga Member UP Manila - Institute of Human Genetics

Engr. Ricardo Bote Member St. Luke's Medical Center

Philippine Science High School Western

V Luna Medical Center, AFP Health

Mariano Marcos Memorial Hospital and

Learning Unit V, College of Medicine

We also acknowledge the inputs from the following experts:

Ms. Catherine Anne Sacopon Research Institute for Tropical Medicine

Ms. Delaram Akhavein World Health Organization

Dr. Sabai Phyu Regional Public Health Laboratories Network

Ms. Camille Ann C. Ople Technical Writer

Dr. Rohani Cena-Navarro UP Manila - National Institutes for Health

Dr. Hyacinth Joy Balderama

Dr. Toni Rose Lamata-Porras Dr. Carole Zaidel Rosales

Ms. Nenita Marayag Ms. Leodymar Jorduela

Mr. Richard Albert Ramones Architect Jean Paolo Policarpo

Ms. Trisha May Sarabia Ms. Joan Guevara

Mr. Lysander Linus De Leon Mr. Teddy Mondres

Mr. Alvin Duazo Mr. Ronald Pastoral

CHAPTER 1 BIORISK MANAGEMENT SYSTEM

CHAPTER 2 ROLES, RESPONSIBILITIES AND AUTHORITIES

STANDARDS (Roles, Responsibilities and Authorities) . . . . 29

Antimicrobial – chemical or physical agent used in the decontamination process to

Antiseptic – substance that prevents growth of microorganism.

Antisepsis – germicidal inhibition or destruction of microbes on skin or tissue.

Assessment – evaluation using science, observation, experience, professional practice

Autoclave – piece of equipment with a chamber that is used to sterilize items by

Biohazard – hazard created by potential transmission of a microbiological agent or

Biohazardous – pertains to biological materials that present potential/detrimental risk to

Biorisk management system - Refers to the effective management of risks posed by

Biorisk Officer – An individual that has advisory functions to the management on

Commissioning – Process of ensuring that all systems and components of a building

Containment – combination of personal practices, procedures, safety equipment,

Control – combination of engineered and procedural measures that ensure materials

Corrective maintenance – involves minor repair of building elements and minor

Decommissioning - Removal/ceasing the use of installed equipment/s and/or facility,

Disease – refers to a specific illness or medical condition, irrespective or origin or

Disinfection – selective killing or inactivation of contaminants to include viruses and

Effluents - Liquid waste or sewage discharged into the sanitary sewer

Genetically modified microorganisms and organisms – microorganisms and

Germicide – any antimicrobial chemical agent used for disinfection, antisepsis or

Hazard – refers to any situation that has potential to cause damage.

High Complexity Facilities - laboratories performing laboratory tests involving highly

High-Efficiency Particulate Air (HEPA) – a device composed of fibrous materials