*
NINETEENTH CONGRESS OF THE 
REPUBLIC OF THE PHILIPPINES 
First Regular Session
)
SENATE 
S. No. .1 9fi
of !i>r ^rr’Tfnrp
'22 JUL-7 P4 58
RECEIVED BV;
Introduced by Senator Christopher Lawrence "Bong" T. Go
AN ACT
PROVIDING FOR THE FRAMEWORK FOR THE ESTABLISHMENT AND 
OPERATION OF VIROLOGY LABORATORIES IN THE PHILIPPINES, 
CREATING FOR THE PURPOSE THE VIROLOGY SCIENCE AND TECHNOLOGY 
INSTITUTE OF THE PHILIPPINES (VIP), APPROPRIATING FUNDS 
THEREFOR AND FOR OTHER PURPOSES
EXPLANATORY NOTE
The recent COVID-19 pandemic exposed the world's unprepared ness in 
handling viral diseases, which led to numerous losses of jobs, economic growth 
opportunities, and most importantly, lives. In the Philippines, its impact's footprints are 
still visible, but similar events in the future are definitely preventable.
Outbreaks like COVID-19 could have been prevented or handled more efficiently 
In the presence of a national virology laboratory that will conduct surveillance, 
diagnosis and monitoring of viral diseases in humans, plants and animals. Issues like 
the recent pandemic and other non-human related viruses should be handled with 
urgency, enough funding, and with the best instruments.
As the government strive to address the situation and save more lives, we must 
learn from these experiences, identify gaps In government response mechanisms, and 
be more proactive in preparing for other similar crises in the future.
In the long term, investing heavily on health research initiatives should be
1


pursued. The virology institute will capacitate the country to conduct scientific research 
initiatives on preventing and treating various viruses and diseases.
This bill seeks to establish a reliable national virology laboratory that shall play 
a critical role in surveillance, diagnosis and monitoring of viral diseases in humans, 
plants and animals as well as in the understanding of the genetic changes in their viral 
genome as a prerequisite for a strong public health response to emerging, re-emerging 
and existing viral diseases in order to raise the level of health of the Filipino and 
improve their social, economic and cultural conditions.
In view of the foregoing, approval of this bill Is earnestly sought.
SENATOR CHRISTOPHER/LAWRENCE "BONG" T. GOV


NINETEENTH CONGRESS OF THE 
REPUBLIC OF THE PHILIPPINES 
First Regular Session
S. No.SENY^6
Senate
Affitr of flic f^rtcftoip
*22 JUL-7 P4S9
Introduced by Senator Christopher Lawrence "Bong" T. Go
AN ACT
PROVIDING FOR THE FRAMEWORK FOR THE ESTABLISHMENT AND 
OPERATION OF VIROLOGY LABORATORIES IN THE PHILIPPINES, CREATING 
FOR THE PURPOSE THE VIROLOGY SCIENCE AND TECHNOLOGY INSTITUTE 
OF THE PHILIPPINES (VIP), APPROPRIATING FUNDS THEREFOR AND FOR 
OTHER PURPOSES
Be it enacted by the Senate and House of Representatives of the Philippines in Congress 
assembled:
1
2
3
4
5
6
7
8 
9
10
11
12
CHAPTER I
GENERAL PROVISIONS
Section 1. Short Title. - This Act shall be known as the "Virology Science and 
Technology Institute of the Philippines (VIP) Act of 2022."
Sec. 2. Declaration of Policy. - It is hereby declared the policy of the State to 
protect and promote the right to health of every Filipino by ensuring that they are 
proactively protected from diseases.
Towards this end, it is also hereby declared the policy of the State to establish a 
reliable national virology laboratory that shall play a critical role in surveillance, 
diagnosis and monitoring of viral diseases humans, plants and animals as well as in the 
understanding of the genetic changes in their viral genome as a prerequisite for a strong 
public health response to emerging, re-emerging and existing viral diseases in order to


1 
raise the level of health of the Filipino and improve their social, economic and cultural
2 
conditions.
3
4 
It is hereby further declared the policy of the State that a systematic approach
5 
to the improvement of our health system requires the establishment of an institution
6 
equipped with the necessary capacity, competency, latitude and authority to decisively
7 
and scientifically respond to the demands of public health and public health
8 
emergencies, crises and situations brought about by viral infections and regulate the
9 
operation of other virology laboratories in order to prevent possible public health threats
10 
resulting from the operation of these laboratories.
11
12 
Sec, 3. Definition of terms. - As used in this Act, the following terms shall mean:
13 
(a) Biosafety is the application of safety precautions that reduce a laboratory
14 
personnel's risk of exposure to a potentially infectious microbe and limit
15 
contamination of the work environment and ultimately the community;
16 
(b) Biosafety ieveis are divided into four (4). Each level has specific controls for the
17 
containment of microbes and biological agents based on internationally-accepted
18 
safety standards. The primary risk that determines the levels of containment are
19 
infectivity, severity of disease transmissibillty and the nature of the work conducted;
20 
(c) Cuiture medium or growth medium is a liquid or gel designed to support the growth
21 
of microorganisms;
22 
(d) Disinfection Is the process using chemical compounds to exterminate
23 
microorganisms but does not necessarily kill all microorganisms especially resistant
24 
bacterial spores;
25 
(e) Infectious waste has been defined to include biological waste, cultures and stocks,
26 
pathological waste, and sharps. Each of these categories has a proper disposal
27 
method. Infectious wastes must either be incinerated or treated prior to disposal.
28 
The following are the infectious wastes:
29 
i. Bioiogicai waste includes blood 
and blood products, excretions, exudates,
30 
secretions, suctionings and other body fluids that cannot be directly discarded
31 
into the municipal sewer system, but excludes articles contaminated with fully
32 
absorbed or dried blood. Biological waste must either be incinerated, sterilized


1
2
3
4
5
6
7
8 
9
10
11
12
13
14
15
16
17
18
19
20 
21 
22
23
24
25
26
27
28
29
30
31
32
11.
with steam in a dedicated autoclave as described below, or treated by some 
other nationally recognized method which has been approved and formally 
adopted by the Department of Environment and Natural Resources (DENR). 
After treatment, biological waste may be treated as normal refuse.
Cultures and stocks include etiologic agents and associated biologicals.
including specimen cultures and dishes and devices used to transfer, inoculate 
and mix cultures. The definition also includes wastes from the production of 
biologicals, serums, and discarded live or attenuated vaccines. Cultures and 
stocks must be treated in the same way as biological waste.
iii. Pathological waste includes biopsy materials, all human tissues, and anatomical 
parts from surgery and other procedures. It also includes carcasses and 
bedding from animals and plants exposed to pathogens in research, but does 
not include teeth or preservative agents such as formaldehyde. Pathological 
waste must be incinerated.
iv. Sharps includes needles, scalpel blades, lancets, glass tubes that could be 
broken during handling and syringes that have been removed from their original 
sterile containers. Sharps must be incinerated.
(f) Kitov test kit is a commercially packaged system of the principal or key components 
of an analytical method used to determine the presence of a specific analyte(s) in 
a given matrix (es). Test kits include directions for their use and are often self- 
contained, complete analytical systems; but they may require supporting supplies 
and equipment. The key components frequently represent proprietary elements or 
reagents that may be readily prepared only by the producer of the kit.
(g) Personal protective equipment consists of garments placed to protect a laboratory 
scientist, worker or any other person from getting infected by a viral agent. It 
consists of standard precautions: gloves, masks and gowns. When working with 
blood or airborne high infections, it shall also include face protection, goggles and 
masks or faces shields, gloves or coveralls, head cover and rubber boots;
(h) Reagent is any natural or synthetic substance used in a chemical or biological 
reaction in order to produce, identify, or measure another substance;
(i) Risk Group I viruses are microorganism that is unlikely to cause human, plant or 
animal disease (e.g. Adeno-associated vims (AAV) types 1-4). These viruses shall


1 
be studied in basic virology laboratories;
2 
(j) Risk Group 2 viruses (moderate individual risk, low community risk) are viral
3 
pathogens that can cause human, plant or animal disease but are unlikely to be a
4 
serious hazard to laboratory workers, the community, livestock or the environment.
5 
Laboratory exposures to these group of viruses may cause serious infection, but
6 
effective treatment and preventive measures are available and the risk of spread of
7 
infection is limited. Assay systems using these viruses shall be done In biosafety
8 
level 2 laboratories. Examples Include herpes viruses, foot-and- mouth disease
9 
viruses, adenoviruses and unconventional slow viruses;
10 
(k) Risk Group 3 viruses (high individual risk, low community risk) are viral pathogens
11 
that usually cause serious human, plant or animal disease but does not ordinarily
12 
spread from one infected individual to another. Effective treatment and preventive
13 
measures are available against these group of viruses. Assay systems using these
14 
viruses shall be conducted in biosafety level 3 laboratories. Examples include human
15 
immunodeficiency vims (HIV), hepatitis B vims (HBV), hantaviruses, Japanese
16 
encephalitis vims (JEV), rabies, rift valley fever and yellow fever vims;
17 
(I) Risk Group 4 viruses (high individual and community risk) are viral pathogens that
18 
usually cause serious human, plant or animal disease and that can be readily
19 
transmitted from one individual to another, directly or indirectly. Effective treatment
20 
and preventive measures are not usually available against these group of viruses.
21 
Assay systems using these viruses shall be made in biosafety level 4 laboratories.
22 
Examples include Lassa fever, filoviruses, smallpox, Crimean- Congo haemorrhagic
23 
fever, avian influenza viruses, Nipah virus, Russian spring-summer encephalitis and
24 
Kyasanur forest disease viruses;
25 
(m) Seroiogy 'xs the scientific study or diagnostic examination of blood serum, especially
26 
with regard to the response of the immune system to pathogens or Introduced
27 
substances;
28 
(n) Smear is a specimen for microscopic study, the material being spread thinly and
29 
unevenly across the slide with a swab or loop, or with the edge of another slide;
30 
(o) Steriiization is the process of exterminating all microorganisms within or outside an
31 
object or material using extreme chemical or physical;
32 
(p) Tissue cuiture refers to a collection of laboratory techniques and methods in which


1
2
3
4
5
6
7
8 
9
10
11
12
13
14
15
16
17
18
19
20 
21 
22
23
24
25
26
27
28
29
30
31
32
fragments of a tissue (human, plant or animal tissue) are introduced into a new, 
artificial environment, where they continue to function or grow; and 
(q) Virology is the study of viruses, vims-like agents including but not limited to their 
taxonomy, disease-producing properties, cultivation and genetics.
CHAPTER II
VIROLOGY SCIENCE AND TECHNOLOGY 
INSTITUTE OF THE PHILIPPINES
Sec. 4. Creation of a Virology Science and Technology Institute of the 
Philippines (VIP). - There is hereby created a Virology Science and Technology 
Institute of the Philippines (VIP), hereinafter referred to as the Institute.
The Institute shall be as an attached agency under the Department of Science 
and Technology (DOST). The DOST, in coordination with the Department of Agriculture 
(DA) and the Department of Health (DOH), shall promulgate policies for and exercise 
supervision and control over the Institute.
Sec. 5. Scope and Coverage of Virology Science and Technology. - For
purposes of this Act, the scope and coverage of the Institute shall be the extensive, 
ground-breaking, pioneering and original research projects on the study of viruses for 
agricultural, industrial, clinical and environmental importance, contagious and non- 
contagious viral diseases from the standpoint of preventive medicine in humans, 
animals and plants, improving human, zoological and botanical health and welfare by 
suppressing infectious and non-infectious viral diseases, and clarifying and supporting 
the scientific background of viruses in relation to zoological, botanical and human health 
and medical administration of the government: Provided, That the Institute shall be the 
national reference laboratory for all zoonotic and botanical infections involving viral 
etiology.
Sec. 6. The Director of the Institute. - The Institute shall be headed by a 
Director, who shall have a rank of an undersecretary and shall be appointed by the


1
2
3
4
5
6
7
8 
9
10
11
12
13
14
15
16
17
18
19
20 
21 
22
23
24
25
26
27
28
29
30
31
32
President of the Philippines upon the recommendation of the Advisory Board created 
under Section 9 of this Act. The Director shall be a qualified virologist possessing a 
postgraduate degree in virology with three (3) to five (5) years of experience in 
diagnostic virology.
The Director shall have overall responsibility for the activities including the 
supervision of all the staff working in the Institute, and shall be directly responsible for 
reporting to the Secretary of Science and Technology and the President of the 
Philippines the results of the various diagnostic assays and research studies performed 
in the Institute.
The Director shall be responsible for the implementation of policies and the 
immediate management of the programs and operations of the Institute including its 
general Institutional affairs, promote research and foster efficient assay and research 
activities.
The Director shall be assisted by a Deputy Director, who shall have a rank of an 
assistant secretary, and shall be appointed by the President of the Philippines upon the 
recommendation of the Advisory Bouncil.
Sec. 7. Powers and Functions. - The Institute shall be the principal laboratory of 
the country in providing quality virology laboratory investigations, researches and 
technical coordination of the entire network of the virology laboratories in the 
Philippines.
The Institute shall perform the following functions:
(a) Conduct basic and applied research projects on zoological, botanical and human 
infectious, non-infectious and other intractable diseases of viral etiology with 
primary focus on their characterization, vector/reservoir transmission, viral ecology, 
clinical virology, pathogenesis, pathophysiology, and host immune response to 
these viral pathogens;
(b) Provide reference services including all that are necessary for ensuring the assay


1 
systems for diseases of viral etiology, industrial and technological implications of
2 
virology and services involving the storing and supplying pathogenic and non-
3 
pathogenic viral agents and their vectors and hosts, standardizing reagents,
4 
preparing and supplying reference materials needed for the diagnosis and
5 
surveillance of plant, animal and human diseases, educating professional
6 
technicians, and information exchange;
7 
(c) Establish testing, reference and biosafety levels 1,2 3, and 4 research laboratories
8 
which are fully compliant with the provisions of this Act and the internationally-
9 
accepted guidelines in the establishment and operation of the same;
10 
(d) Conduct viral disease surveillance program, collection, analysis, and feedback and
11 
distribution of information on diseases of viral etiology;
12 
(e) Comprehensively coordinate the planning and implementation of research projects,
13 
approve liaison and coordination with relevant governmental agencies, and
14 
coordinate research projects with other research institutions;
15 
(f) Provide technical advice to national authorities on the progress, needs and
16 
aspirations of the virology laboratory network in the country and to regulate the
17 
operation of the same;
18 
(g) Assist national authorities in the planning, organization and supervision of the
19 
virology laboratory network;
20 
(h) Develop technical/training material for use in laboratories in the network to enhance
21 
their quality;
22 
(i) Assess the needs and impart training to the staff of other virology laboratories in
23 
the country in quality testing for viral pathogens;
24 
(j) Validate reagents and kits that may be used nationally;
25 
(k) Validate new technologies that may become available and recommend their
26 
implementation in the country;
27 
(I) Develop minimum standards, standard operating procedures and research
28 
protocols for virology laboratories and assist virology laboratories in their
29 
implementation of the same;
30 
(m) Develop, in consultation with the DOH, DA, other relevant government agencies,
31 
the academe, and private enterprises engaged in the industry of virology, a national
32 
database of viruses and laboratory results;


1 
(n) Organize external quality assessment schemes to periodically assess the quality of
2 
testing in networks and suggest remedial measures to those laboratories that show
3 
poor performance;
4 
(o) Undertake research to improve the quality and cost-effectiveness of virology
5 
laboratory services in 
the country;
6 
(p) Collaborate with the World Health Organization (WHO) and other international
7 
agencies in virology researches and technical matters pertaining to improvement of
8 
laboratories;
9 
(q) Create within the Institute various divisions that will spearhead basic and applied
10 
molecular biological research and reference activities in arbovirology, emerging and
11 
reemerging viral diseases, neurovirology, herpes virology, enteric virology, tumor
12 
virology, hepatitis virology, acute viral respiratory infections and cytokines, viral
13 
genomics and molecular genetics and biosafety control studies of viruses, among
14 
others;
15 
(r) Promulgate rules and regulations regarding the management and operation of
16 
virology laboratories in the country as well as its rules of engagement;
17 
(s) Collect fees in connection with the exercise of Its regulatory powers;
18 
(t) Apply for, receive, and accept bequests, grants, and donation of funds, equipment,
19 
materials and services needed for the attainment of its objectives;
20 
(u) Provide grants, research fund, materials and equipment for the conduct of virology
21 
researches by both public and private higher education institutions;
22 
(v) Order the suspension or closure of virology laboratories and prosecution of
23 
individuals and corporations for violations of this Act;
24 
(w) Establish an editorial office of a refereed journal of virology to published it and a
25 
library which shall to collect and preserve books, journals and other reference
26 
materials in the field of virology; and
27 
(x) Perform such other related activities as may be assigned by the DOST.
28
29 
Sec. 8. Organization and Personnel. - The Institute shall have Its technical
30 
and administrative support staff as well as consultants as may be necessary. Such
31 
consultants may be drawn from the public and private sectors on consultancy or
32 
contractual basis and shall be granted honoraria or allowances at such amounts as may


1
2
3
4
5
6
7
8 
9
10
11
12
13
14
15
16
17
18
19
20 
21 
22
23
24
25
26
27
28
29
30
31
32
be determined in accordance with existing rules and regulations.
All laboratory workers shall undergo periodic training to increase their laboratory 
competencies. Attendance to conferences, seminars and trainings shall be given 
additional service credits.
Sec. 9. Advisory Board, - The Institute shall have an Advisory Board composed 
of the following officials or their representatives:
(a) The Secretary of Science and Technology, Chairman;
(b) The Secretary of Health, Co-Chairman;
(c) The Secretary of Agriculture, Co-Chairman; and
(d) Ten (10) members from the academe who must have distinguished 
themselves in the field of medical virology, genomics, plant virology, animal 
virology, epidemiology, genetic engineering and other related disciplines and 
shall be appointed by the President of the Philippines.
Sec. 10. Transfer of Biomedical Research Functions, - All functions in the 
Department of Health involving biomedical research in virology and in the Department 
of Agriculture involving animal and plant virology shall be transferred to the Institute 
together with their applicable appropriations, records, equipment, property and such 
personnel as may be necessary.
Notwithstanding the provisions of this law, the Research Institute for Tropical 
Medicine shall retain its existing mandate on reference laboratories for public health 
purposes, as stipulated in relevant laws and rules.
CHAPTER III
VIROLOGY LABORATORY OPERATIONS
Sec. 11. Physical structure of virology laboratories, - All newly constructed 
virology laboratories shall be located in separate, multi-storied buildings.


1 
A virology laboratory shall be situated at the end of a corridor in a building where
2 
other laboratories are located in order to restrict entry of visitors, prevent contamination
3 
and facilitate maintaining biosafety standards. In cases of existing laboratories, they
4 
shall be separated from other areas and facilities that are open to unrestricted staff
5 
movement within the building.
6
7 
Sec. 12, Essential features of a virology laboratory, - Apart from the
8 
biosafety requirements, the following shall be the minimum essential features that must
9 
to be incorporated in the design of a virology laboratory:
10 
(a) Adequate space shall be provided for the safe conduct of laboratory work and for
11 
cleaning and maintenance. Designated cubicles, rooms or areas shall be available
12 
to carry out different activities, e.g. office rooms, specimen collection cubicle,
13 
specimen reception and processing room, serology laboratory, cell culture cubicle,
14 
molecular diagnostic laboratory comprising three cubicles, cold room, dark room
15 
for fluorescent microscopy, common equipment room, media preparation room,
16 
washing and sterilization section, store room, toilets and lunch room;
17 
(b) Each laboratory room shall have a space for housing a biosafety level 2 cabinet,
18 
one workbench, a sink, discard bins, wall cabinets to store consumables, a
19 
centrifuge, an incubator and a refrigerator;
20 
(c) The entire laboratory shall be climate-controlled to maintain a dust-free
21 
environment and an ambient temperature of 22-25 °C. Least cell culture cubicles,
22 
virus handling cubicles, the serology lab and the molecular biology labs shall also
23 
be air conditioned;
24 
(d) Walls, ceilings and floors shall be smooth, easy to clean, impermeable to liquids
25 
and resistant to chemicals and disinfectants normally used in the laboratory. Floors
26 
shall be slip- resistant;
27 
(e) Bench-tops shall be impervious to water and resistant to disinfectants, acids,
28 
alkalis, organic solvents and moderate heat;
29 
(f) Illumination shall be adequate for all activities. Undesirable reflections and glare
30 
shall be avoided;
31 
(g) Laboratory furniture shall be sturdy. Open spaces between and under benches,
32 
cabinets and equipment shall be accessible to cleaning;
10


1 
(h) Storage space shall be adequate to hold supplies for immediate use and thus
2 
prevent clutter on bench tops and in aisles. Additional long-term storage space
3 
conveniently located within or outside the laboratory area shall also be provided;
4 
(i) 
All doors shall have vision panels, appropriate fire ratings and self-closing;
5 
(j) Facilities for storing outer garments, personal items, pantry and restrooms shall
6 
be provided outside the laboratory working area;
7 
(k) Hand-washing basins with running tap water shall be provided in each laboratory
8 
room, preferably near the exit door. A dependable supply of good quality water
9 
shall essential. There must be no cross-connections between sources of laboratory
10 
water supply and drinking water supplies;
11 
(I) 
There shall be reliable and adequate electricity supply and emergency lighting for
12 
safe exits. A stand-by generator shall be available at least for some equipment
13 
such as incubators, biosafety cabinets, freezers etc.; and
14 
(m) Safety systems shall cover fire, electrical emergencies, emergency shower and
15 
eyewash facilities including systems for avoiding overcrowding and too much
16 
equipment, pest control and prevention particularly rodents and arthropods and
17 
prevention of unauthorized entry into the laboratory areas.
18
19 
Sec. 13. Equipment and supplies. - The virology laboratory shall have adequate
20 
equipment which shall take into account certain general principles, including:
21 
(a) The equipment, facilities and supplies must be designed to prevent or limit contact
22 
between the operator and the infectious material (e.g. biosafety cabinets, electronic
23 
pipetting aids, etc.);
24 
(b)The equipment and facilities must be made of materials that are impermeable to
25 
liquids, resistant to corrosion and meet internationally-accepted structural
26 
requirements;
27 
(c) The equipment and facilities must be free of sharp edges, burrs and unguarded
28 
moving parts;
29 
(d)The equipment and facilities must be designed, constructed and installed to facilitate
30 
simple operation and provide for ease of maintenance, cleaning, decontamination
31 
and certification testing; and
32 
(e) Glasswares and other breakable materials must be avoided wherever possible.
11


1 
Essential and desirable equipment required for a virology laboratory must conform
2 
with standards set by the Institute and Internationally-recognized manuals and
3 
guidelines for virology laboratory operations.
4
5 
Sec. 14. Biosafety requirements of laboratories. - The biosafety infrastructure
6 
shall be designed on the basis of risk assessment for handling specific pathogens. The
7 
desired biosafety levels shall be established on the basis of professional judgement
8 
based on risk assessment and on internationally-accepted guidelines on the handling
9 
and management of specific viral agents.
10 
(a) In addition to the minimum essential features stipulated in Section 12, a biosafety
11 
level 2 laboratory shall have the following minimum requirements:
12 
1. 
Inward airflow ventilation or controlled ventilating system;
13 
2. 
On-site Autoclave: and
14 
3. 
Biological safety cabinets.
15 
(b) In addition to the minimum essential features stipulated in Section 12, biosafety
16 
level 3 and 4 laboratories shall have the following minimum requirements:
17 
1. Isolation of laboratory;
18 
2. Room sealable for decontamination;
19 
3. Inward airflow ventilation, controlled ventilating system and HEPA-filtered;
20 
4. Double-door entry;
21 
5. Airlock;
22 
6. Airlock with shower;
23 
7. Anteroom;
24 
8. Anteroom with shower;
25 
9. Effluent treatment;
26 
10. On site, in-laboratory and double-ended Autoclave;
27 
11. Biological safety cabinets; and
28 
12. Personal safety monitoring capability.
29 
(c) Biosafety level 3 and 4 laboratories must be separated from general traffic flow and
30 
accessed through an anteroom (with double door entry or basic laboratory - Biosafety
31 
Level 2) or an airlock.
32 
(d) An autoclave must available within the facility for decontamination of wastes prior to
33 
disposal.
12


1 
(e) A sink with hands-free operation must available.
2 
(f) Inward directional airflow must be established and ali work with infectious materials
3 
must conducted within a bioiogicai safety cabinet.
4
5 
Sec. 15. Handling of viruses and specimens containing viruses. - Unless the
6 
recommended biosafety level facilities are available, the laboratory should not handle a
7 
particular virus. In situations where there is an outbreak of a viral illness and the required
8 
biosafety leveis are not avaiiabie, the specimen shali be coliected and referred to the
9 
nearest laboratory that has the required biosafety laboratory. Specimens coilected from
10 
patients who are suspected of suffering from viral infections caused by agents under
11 
risk groups 3 or 4 shali be directly forwarded to the reference laboratory or the Institute
12 
which has the required facilities for the handling such agents.
13
14 
Sec. 16. Minimum staff requirement for a virology laboratory. - The minimum
15 
staff requirements for a virology laboratory shall include:
16 
(a) A qualified virologist possessing a postgraduate qualification in viroiogy
17 
with three years of experience in diagnostic viroiogy shall be the chief of the laboratory.
18 
He shall have overall responsibility for the activities of the laboratory and shall supervise
19 
all the staff working in it. In addition, he shall be directly responsible for reporting resuits
20 
of the various diagnostic assays performed in the laboratory;
21 
(b) Two junior microbiologists possessing a master's degree in medicai, animal
22 
or plant microbiology with one to two years of experience in diagnostic virology. These
23 
microbiologists shail be responsible for the day-to-day operation of the laboratory
24 
Including the supervision of technical staff who carry out the various diagnostic tests,
25 
stock management and procurement of laboratory supplies and diagnostic kits, quality
26 
control and quality assurance;
27 
(c) Two laboratory technologists possessing a bachelor's degree in medical
28 
technology, one to be trained in cell culture and virus isolation methods and the other
29 
to be trained in serology. The technicians shall be responsible for specimen processing,
30 
testing, laboratory safety, maintenance of laboratory records and media preparation;
31 
and
32 
(d) One or two laboratory supportive staff.
33 
(e) The duties and responsibilities of all the staff shall be clearly outlined and
13


1
2
3
4
5
6
7
8 
9
10
11
12
13
14
15
16
17
18
19
20 
21 
22
23
24
25
26
27
28
29
30
31
32
33
they shall be provided with periodic training to upgrade the knowledge and skills 
of the laboratory operation and management to ensure that the laboratory is 
abreast with contemporary diagnostic methodology as well as maintain quality in 
the services rendered.
Sec. 17. Use of persona! protective equipment in viroiogy iaboratories.
- Specially designed coveralls which afford protection up to the neck, facemasks or frill 
face respirators and gloves shall be used at all times in the virology laboratory. Additional 
personal protective equipment shall be used when handling highly pathogenic viruses.
Sec. 18. Amenities. - Hand basins must be provided in each laboratory. Lockers 
for staff clothing must be available outside but near the laboratory rooms. Pantry/rooms 
for eating and drinking must be provided close to laboratory rooms.
Sec. 19. Health of staff. - Pre-employment medical examination for all staff shall 
be made. Medical monitoring for workers in biosafety level 3 and 4 laboratories shall 
also be conducted regularly. The scope of the monitoring shall depend on the agent 
being handled. Women who work with viruses must disclose their pregnancy as soon as 
possible. Individual evaluation of the risks involved In continued employment in the 
virology laboratory must also be done.
Sec. 20. Medical surveillance. - A system that records and follows up all cases of 
illness among laboratory staff to ascertain the source of infection and initiate any follow­
up action shall be developed.
Sec. 21. Accidents. -
(a) 
All accidents causing personal injury with or without exposure to infectious agents 
shall be reported to the supervisor or safety officer. Records should be kept of all 
staff sicknesses, injuries and accidents, and of x-rays and immunization;
(b) 
A qualified first-aid provider must be present at all times in the laboratory. He/she 
must receive additional training in dealing with exposure to and ingestion of 
Infectious, toxic and corrosive chemicals;
(c) 
A well sign-posted standard first aid kit for minor Injuries must be in a conspicuous
14


1
2
3
4
5
6
7
8 
9
10
11
12
13
14
15
16
17
18
19
20 
21 
22
23
24
25
26
27
28
29
30
31
32
33
location inside the laboratory; and
(d) Standard operating procedures for management of post-exposure prophylaxis 
must be in place.
CHAPTER IV
LABORATORY WASTE MANAGEMENT
Sec. 22. Management of laboratory waste. - Laboratory waste shall be segregated 
Into color-coded containers corresponding those for Incineration, for autoclaving, normal 
household waste and for soiled linens.
The following practical methods shall be used in treating contaminated laboratory
waste:
(a) 
Sterilization by autoclaving using timed exposure of materials to steam above 
atmospheric pressure at temperatures above 100°C.
(b) 
Chemical disinfection which is regarded as the first line defense, especially in the 
case of discarded bench equipment, and which should be followed by autoclaving 
or incineration. Chemical disinfection shall use clear sodium hypochlorite, clear 
phenolics, alcohols and aldehydes.
(c) 
Incineration involves the transport of waste materials off-site for disposal using an 
incinerator.
(d) 
Other internationally-accepted forms of disinfection and decontamination shall be 
employed in effectively preventing accidents and contamination.
Sec. 23. Infectious waste. - Infectious wastes shall be segregated from general 
wastes as they need to be autoclaved or incinerated before being removed from the 
area in which they are generated.
Sec. 24. Routine contaminated wastes. - Laboratory workers shall take care to 
segregate their wastes from general wastes. General wastes shall be decontaminated 
prior to removal from the area in which they are generated. Internationally-accepted 
alternative means of decontamination to autoclaving or incineration may be used, 
provided they are effective.
15


1
2
3
4
5
6
7
8 
9
10
11
12
13
14
15
16
17
18
19
20 
21 
22
23
24
25
26
27
28
29
30
31
32
33
Sec. 25. Management of sharps. - All sharps shall be segregated from other 
wastes and placed in dedicated and labelled single-use rigid containers immediately after 
use. Sharps containers shall not be compacted or emptied into ordinary waste streams.
Sec. 26. Labelling of wastes. -
(a) All wastes shall be identified with an appropriate type of label which shall remain 
attached to the waste. The label shall state the nature of waste material, the 
department, date, and the name of the person responsible for the waste.
(b) In transporting wastes through buildings and across campus, the main consideration 
shall be the non-exposure of anyone to the risks from the contaminated material. 
Containers shall be leak-proof.
(c) Wastes shall be decontaminated as far as is practical before removal from the area 
of generation. All laboratories shall have access to local autoclave and other 
appropriate decontamination facilities so as to minimize the need to transport 
contaminated wastes around laboratories.
CHAPTER V
QUALITY SYSTEMS IN VIROLOGY LABORATORIES
Sec. 27. Quality systems. - A quality system shall be instituted in all virology 
laboratories. It shall be comprehensive and shall cover all aspects from the decision to 
collect the specimen to the interpretation of results. Systematic efforts through 
organizational structure and efficient utilization of resources shall be used implement all 
the steps that shall assure generation of quality reports by the laboratory. It shall aim 
at consistency, reproducibility, traceability and efficaciousness of the laboratory services.
Sec. 28. Documentation. - Routine procedures shall be described in written 
Standard Operating Procedures (SOPs). They shall be reviewed regularly and modified, 
if necessary. The modified versions shall be signed and dated by the laboratory director. 
The most recent version of SOPs shall be available directly at the work place. The old 
versions shall be kept in the laboratory and shall be archived if required. The records 
shall be stored for long periods of time but shall be available for prompt retrieval. Safe
16


1
2
3
4
5
6
7
8 
9
10
11
12
13
14
15
16
17
18
19
20 
21 
22
23
24
25
26
27
28
29
30
archiving of all records shall be ensured.
Archiving of the source documents and other essential documents shall be done in such 
a way that data are kept in an integer state and can neither be lost nor altered to achieve 
this goal. Records of usage, maintenance and calibration shall be kept in the laboratory 
and shall be routinely monitored. Reports of the tests shall be released only after proper 
scrutiny and documentation of the scrutiny with the signature and date by the laboratory 
supervisor.
Sec. 29. Standard operating procedure (SOP). - SOP is one of the most 
important documents in a diagnostic laboratory. Apart from providing the complete 
details of how exactly a test or a procedure is carried out in a laboratory, the SOP shall 
provide information on specimen collection, laboratory safety instructions, purpose and 
limitations of the procedure, turnaround times, interpretation of results, and above all, 
the line of authority. The procedure manual used in the laboratory shall be complete 
enough in detail in order that any laboratory scientist can perform the procedure without 
additional information. One copy of the manual shall be readily available to bench 
personnel, and another copy shall be stored separately in case of accidents. A document 
control system shall be instituted to ensure that up-to-date document are used.
Sec. 30. Quality control checks areas. - The following, among others, shall 
be the minimum critical quality control check areas:
(a) 
Specimen transport. Viral specimens held for short periods shall be 
refrigerated, while those for longer periods shall be frozen at -20°C or -70°C;
(b) 
Transport media. The composition and type of viral transport media can affect 
viral isolation rates. Culture media shall be a balanced isotonic solution at 
physiological pH. It shall contain a substance that will stabilize the virus such 
as gelatin, fetal calf serum or bovine serum albumin, and antibiotics against 
bacteria and fungi. The swab shall be made of a material that is non-toxic to 
viruses
17


1 
(c) Smears. Smears must contain a reasonable number of cells, be of a reasonable
2 
size, and not mixed with blood or pus in order to avoid non-specific staining;
3 
(d) Specimens for serology. Excessively haemolyzed, lipaemic, bacterially-
4 
contaminated, or leaking specimens shall be rejected. Sera shall be heat-
5 
Inactivated depending on the tests to be performed. In the event of a specimen
6 
being rejected, the sender shall be informed, preferably by an oral report
7 
followed by a written one. Extenuating circumstances may warrant the
8 
acceptance of a substandard specimen;
9 
(e) Tissue culture and media. Within a given cell line, there may be significant
10 
variations in sensitivity to vims isolation which may depend on the particular cell
11 
line or clone and the passage number. Information on a particular cell line shall
12 
be recorded accurately including the source, type, passage number, confluency
13 
and cell condition. These back-up systems shall include freezing and storage of
14 
low passage cells at -70°C liquid nitrogen tanks, use of paired stock flasks or
15 
carrying of a parallel set of stock flasks using a separate set of tissue culture
16 
reagents and glassware;
17 
Other quality control procedures that may aid in minimizing the risk of
18 
contamination shall include the exclusion of laboratory with infectious diseases
19 
from handling tissue culture, and separate laboratory apparel, reagents and
20 
glassware for tissue culture. Cell lines shall be handled separately and the
21 
cabinet shall be decontaminated in between uses;
22 
(f) Media. Following filter sterilization, aliquots of the media shall be taken and
23 
checked for bacteriological or fungal contamination. These samples shall be
24 
examined daily for five days and must be free from contamination. Aliquots of
25 
all other medium components such as fetal calf serum and L-glutamine shall
26 
also be checked. New lots of medium and fetal calf serum that have passed the
27 
sterility check shall be monitored for their ability to support cell growth;
28 
(g) Reagents and kits. Reagents and kits shall only be ordered from reputable
29 
manufacturers and dealers with reliable transportation systems. Upon receipt,
30 
the reagents shall be checked for obvious breakage or contamination. The
31 
quantity, source, lot number and date of receipt shall be entered in a logbook
32 
and the reagents stored according to the manufacturer's storage specifications.
18


1 
When new lots of any reagent are opened, the date shall be noted on the
2 
container. Caution shall be exercised in the case of kits as different components
3 
of a kit may require different storage conditions and have different expiration
4 
dates; and
5 
(h) Instruments. Laboratory instruments shall be subjected to routine preventive
6 
maintenance and checked and calibrated on a regular basis. Some of these
7 
checks may be performed by laboratory staff and entered into a logbook. The
8 
following shall be the minimum routine laboratory maintenance and
9 
performance checks on instruments:
10 
\. Incubators: daily temperature, C02 and humidity checks. Weekly
11 
decontamination of interior;
12 
ii. Safety cabinets: daily air pressure check and cleaning of UV lamp.
13 
Work surface should be decontaminated after each use. Annual
14 
checks for air velocity and filter integrity and paraldehyde
15 
decontamination, as applicable;
16 
iii. Microscopes: daily cleaning of objectives and stage, log of lamp
17 
usage and annual overhaul. Refrigerators and freezers: daily
18 
temperature check; annual check of compressor and refrigerant
19 
levels;
20 
iv. Water baths: daily temperature checks, weekly decontamination;
21 
V. Refrigerated centrifuges: weekly decontamination, annual
22 
inspection of motor, speed calibration and drive system;
23 
vi. Autociaves: daily temperature check and monthly spore strip
24 
testing;
25 
y\\.pH meters: single reference buffer check before each use, multiple
26 
point check monthly; and
27 
viii. Pipetting devices: gravimetric volume check monthly; annual overhaul.
28
29 
Sec. 31. Continuing professional education. - All virology laboratories shall
30 
regularly provide local and international education and training to its laboratory
31 
workers at the expense of the laboratory.
32
19


1
2
3
4
5
6
7
8 
9
10
11
12
13
14
15
16
17
18
19
20 
21 
22
23
24
25
26
27
28
29
30
31
32
Sec. 32- Incentives of laboratory workers. - The DOST shall device a 
scheme which shall provide incentives to laboratory workers in virology laboratories 
whose outputs result in high-impact medical, agricultural, technological and industrial 
innovations.
Sec. 33. Assessment of Quality System. - The quality system shall be 
assessed either through an onsite inspection (audit) or by sending known but 
undisclosed material to the laboratories for testing (quality assessment scheme). The 
latter can be done within the Institute by internal staff (internal quality assessment 
scheme - IQAS) or through an external agency (external quality assessment scheme 
- EQAS).
CHAPTER VI 
PENALTY PROVISIONS
Sec. 34. Penalties. -
(a) In addition to acts or omissions already penalized by existing laws, the following 
faults or omissions shall be punishable by imprisonment of at least 12 years and 1 
day to 20 years (reclusion temporal) ov a fine of not less than five hundred thousand 
pesos (P500,000.00) but not more than five million pesos (P5,000,000.00), or both, 
such imprisonment and fine, at the discretion of the court:
i. 
Any person who introduces high-risk viral pathogens into the domestic 
environment without obtaining a permit, in violation Section 15 of this 
Act.
ii. 
Any person who refuses, interferes with, or evades an inspection for the 
safety control of high-risk viral pathogens;
iii. 
Any person who neglects to apply for permit for the operation of the 
virology laboratory;
iv. Any person who makes a false statement, presents false materials or 
documents, or intentionally omits or conceals any fact, in violation of any 
of the provision of this Act;
(b) In addition to acts or omissions already penalized by existing laws, the following
20


1
2
3
4
5
6
7
8 
9
10
11
12
13
14
15
16
17
18
19
20 
21 
22
23
24
25
26
27
28
29
30
faults or omissions shall be punishable by imprisonment of at least 6 years and 1 
day to 12 years (prision mayor) or a fine of not less than one hundred thousand 
pesos (PlOO,000.00) but not more than one million pesos (PI,000,000.00), or both, 
such imprisonment and fine, at the discretion of the court:
i. 
Any person who operates a virology laboratory in violation of Sections 11, 
12, 13 and 14 of this Act.
ii. 
Any person who disposes laboratory waste in violation of Sections 22, 23, 
24, 25 and 26 of this Act;
(c) In addition to acts or omissions already penalized by existing laws, the following 
faults or omissions shall be punishable by imprisonment of at least 6 months and 
1 day to 6 years (prision correctionai) or a fine of not less than one hundred 
thousand pesos (PI 00,000.00) but not more than five hundred thousand pesos 
(P500,000.00), or both, such imprisonment and fine, at the discretion of the court:
i. Any person who operates a virology laboratory in violation of Sections 
16, 17, 18, 19, 20 and 21 of this Act.
ii. Any person who operates a virology laboratory in violation of Sections 
27, 28, 29, 30, 31, 32 and 33 of this Act;
Sec. 35. Joint Penalty. - Where a representative of a corporation, or an agent 
or an employee of, or any other person employed by, a corporation or individual 
commits any violation of the provisions of this Act in connection with the business of 
the corporation or individual, in addition to the punishment of such violator, the 
corporation or individual shall be punished by a fine under the respective provisions of 
Section 34.
Sec. 36. Administrative Penalty. - In addition to acts or omissions already 
penalized by existing laws, the any government official or employee who, by fault or 
omission, violates any provision of this Act shall be perpetually disqualified from 
holding public office with forfeiture of benefits in favor of the State.
21


1
2
3
4
5
6
7
8 
9
10
11
12
13
14
15
16
17
18
19
20 
21 
22
23
24
25
26
27
28
29
30
31
32
CHAPTER VII 
OTHER PROVISIONS
Sec. 37. Congressional Overnight Committee on the Virology Science 
and Technology Institute of the Philippines — To monitor the implementation of 
this Act, there shall be a Congressional Oversight Committee on the Virology Science 
and Technology Institute of the Philippines, composed of the Chair and four (4) 
members of the House Committee on Science and Technology, Chair of the House 
Committees on Health and Agriculture and Food and the Chair and four (4) members 
of the Senate Committee on Science and Technology, and the Chair of the Committees 
on Health and Demography and Agriculture, Food and Agrarian Reform. No part of this 
Act shall be construed as to limit the oversight powers inherently or actually possessed 
by the same committees.
Sec. 38. Staffing. —The Secretary of Science and Technology, in consultation 
with the Department of Budget and Management (DBM), shall determine the 
organizational structures, qualification standards, staffing pattern and compensation 
of the newly created Institute and other positions which are established under this Act 
in accordance with existing laws, rules and regulations.
Sec. 39. Appropriations. - The amount needed for the initial implementation 
of this Act shall be taken from the current year's appropriations of the DOST. 
Thereafter, such sums, as may be necessary for its continued implementation, shall be 
included in the annual General Appropriations Act.
Sec. 40. Implementing Rules and Regulations. - The Secretary of Science 
and Technology shall promulgate the necessary rules and regulations within ninety 
(90) working days from the effectivity of this Act.
Sec. 41. Separability Clause. — If any portion or provision of this Act is 
subsequently declared invalid or unconstitutional, other provisions hereof which are 
not affected thereby shall remain in fill force and effect.
22


Sec. 42. Repealing Clause. — All other laws, acts, presidential decrees, 
executive orders, presidential proclamations, issuances, rules and regulations, or parts 
thereof which are contrary to or inconsistent with any of the provisions of this Act are 
hereby repealed, amended, or modified accordingly.
Sec. 43. Effectivity. — This Act shall take effect fifteen (15) days after its 
publication in the Official Gazette or in a newspaper of general circulation.
Approved,
23