Republic of the Philippines
HOUSEOF REPRESENTATIVES
Quezon City

EIGHTEENTH CONGRESS
First Regular Session

6798

HOUSE BILL NO.

INTRODUCED BY:
HONORABLE CHERYL P. DELOSO-MONTALLA
Representative, 2" District, Zambales

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

“Emerging infectious diseases caused by viruses have assumed great public health
significance in the recent past. During the last three decades, almost 20 new viral pathogens have
been detected. Some of these-e.g. human immunodeficiency virus (HIV) and hepatitis viruses—
have already caused substantial mortality, morbidity and economic loss all over the world. The
pandemic of serious acute respiratory syndrome (SARS) unequivocally demonstrated the rapidity
with which new viruses can travel across the world and inflict misery. The threat of a pandemic
with one of the subtypes of influenza virus is considered the greatest public health challenge in the
current millennium so far.”!

Of late, however, Corona Virus 19 took the global center stage when it put the whole world
toa halt, wrought havoc to every comer of the globe, put global trade to a halt and left nations
helpless amidst the virulence that it displays.

“Laboratories play a critical role in surveillance, diagnosis and monitoring of viral disease
as well as in the understanding of the genetic changes in the viral genome. Laboratory tools are
also essential for the diagnosis of dengue fever and chikungunya fever-two of the important
vector-borne viral diseases-and for differentiating from other fevers for institution of rational and
specific therapy and control measures.”?

The “establishment of a reliable virology laboratory is a prerequisite for a strong public
health response to emerging viral diseases. Unfortunately, several developing countries lack
adequate capacity to diagnose viral infections.”>

This bill is in response to the call of the Department of Science and Technology for the
creation of a government-owned, biosafety level 4 laboratory which will serve as the premier
virology laboratory of the country.

The proposed Virology Science and Technology Institute of the Philippines shall conduct
innovative scientific researches on viral agents requiring high or maximum containment (biosafety

1 WHO Guidelines on establishment of virology laboratory in developing countries. World Health Organization
2008
bid.
Ibid


level 2 to 4). Under this bill, research studies shall focus on vector reservoir, transmission, viral
ecology, pathogenesis, pathophysiology and human, animal or plant host response of these viral
pathogens. A significant goal of this bill is the development of diagnostics, vaccines and
therapeutics against these viral agents.

In addition to its role in research innovation, the Institute shall also be tasked to become
the reference laboratory for animal and plant virology studies. This will enable our country to be
equipped with the knowledge about viral agents in plants and animals and their economic
implications to agriculture.

The Institute is also mandated to become the regulatory authority for the establishment and
operation of virology laboratories in the country. It shall be empowered to promulgate rules and
regulations regarding virology laboratory operations.

Finally, this bill defines the minimum required standards for the establishment, operation
and maintenance of virology laboratory in the country considering that internationally-accepted
standards for the operation of virology laboratories are rapidly upgrading.

The establishment of the Institute as well as the other virology laboratories in the country
can spur the development of genetics and bioinformatics data on pathogenic and beneficial viruses
‘and their corresponding implications in medical management and therapeutics, genetic
engineering, animal husbandry and botanical economics.

Viral pathogenic and genetic information derived from the researches in the Institute as
well as in other virology laboratories in the country can be used to guide the (1) monitoring of
disease outbreaks by determining the prevalent strains, (2) management of infected patients by
identifying drug-resistant strains, and (3) aid in the design of vaccines and antiviral drugs by
identifying molecular targets. The development of vaccines and antiviral compounds to eradicate
and control the spread of viral infections is a promising area of research that may have significant
socioeconomic impact.”

The vast array of underutilized virology research in the science industry of our country is
due to our limited capacity to perform these researches. This bill is also a response to that.

Immediate passage of this bill is earnestly sought.

YL P. DELOSO-MONTALLA
resentative
2™ District, Zambales

* http://wnww.icb.osaka-u.ac.jp/AnnuRep/AnnuRep35/276-292.pdf


Republic of the Philippines
HOUSEOF REPRESENTATIVES
Quezon City

EIGHTEENTH CONGRESS
First Regular Session

6798

ee
INTRODUCED BY:
HONORABLE CHERYL P. DELOSO-MONTALLA
Representative, 2" District, Zambales

——__

HOUSE BILL NO.

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:

Section 1. Short Title.—This Act shall be known as the “Virology Science and Technology
Institute of the Philippines (VIP) Act”

Section 2. Declaration of Policy. ~It is hereby declared the mandatory 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 raise the level of health of the Filipino and improve their
social, economic and cultural conditions.

It is hereby further declared the policy of the State that a systematic approach to the
improvement of our health system requires the establishment of an institution equipped with the
necessary capacity, competency, latitude and authority to decisively and scientifically respond to
the demands of public health and public health emergencies, crises and situations brought about
by viral infections and regulate the operation of other virology laboratories in order to prevent
possible public health threats resulting from the operation of these laboratories.

Section 3. Definition of terms. - As used in this Act, the following terms shall mean:

a. Biosafety is the application of safety precautions that reduce a laboratory
personnel’s risk of exposure to a potentially infectious microbe and limit contamination of the
work environment and ultimately the community;

b. Biosafety levels are divided into 4. Each level has specific controls for the
containment of microbes and biological agents based on internationally-accepted safety standards.
The primary risk that determines the levels of containment are infectivity, severity of disease
transmissibility and the nature of the work conducted;


Culture medium or growth medium is aliquid or gel designed to support the growth
of microorganisms.

4. Disinfection is the process using chemical compounds to exterminate
microorganisms but does not necessarily kill all microorganisms especially resistant bacterial
spores;

e. __ Infectious waste has been defined to include biological waste, cultures and stocks,
pathological waste, and sharps. Each of these categories has a proper disposal method. Infectious
‘wastes must either be incinerated or treated prior to disposal. The following are the infectious
wastes:

i. Biological waste includes blood and blood products, excretions, exudates,
secretions, suctionings and other body fluids that cannot be directly discarded into the
‘municipal sewer system, but excludes articles contaminated with fully absorbed or dried
blood. Biological waste must either be incinerated, sterilized 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

ii, 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.

i 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£ Kit or 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.

2 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 hields, 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 1 viruses are microorganism that is unlikely to cause human, plant or
animal disease (e.g. Adeno-associated virus (AAV) types 1-4). These viruses shall be studied in
basic virology laboratories;

j. Risk Group 2 viruses (moderate individual risk, low community risk) are viral
pathogens that can cause human, plant or animal disease but are unlikely to be a serious hazard to


laboratory workers, the community, livestock or the environment. Laboratory exposures to these
‘group of viruses may cause serious infection, but effective treatment and preventive measures are
available and the risk of spread of infection is limited. Assay systems using these viruses shall be
done in biosafety level 2 laboratories. Examples include herpes viruses, foot-and- mouth disease
viruses, adenoviruses and unconventional slow viruses;

k. Risk Group 3 viruses (high individual risk, low community risk) are viral pathogens
that usually cause serious human, plant or animal disease but does not ordinarily spread from one
infected individual to another. Effective treatment and preventive measures are available against
these group of viruses. Assay systems using these viruses shall be conducted in biosafety level 3
laboratories. Examples include human immunodeficiency virus (HIV), hepatitis B virus (HBV),
hantaviruses, Japanese encephalitis virus (JEV), rabies, rift valley fever and yellow fever virus;

|. Risk Group 4 viruses (high individual and community risk) are viral pathogens that
usually cause serious human, plant or animal disease and that can be readily transmitted from one
individual to another, directly or indirectly. Effective treatment and preventive measures are not
usually available against these group of viruses. Assay systems using these viruses shall be made
in biosafety level 4 laboratories. Examples include Lassa fever, filoviruses, smallpox, Crimean-
Congo haemorrhagic fever, avian influenza viruses, Nipah virus, Russian spring-summer
encephalitis and Kyasanur forest disease viruses;

m. Serology is the scientific study or diagnostic examination of blood serum,
especially with regard to the response of the immune system to pathogens or introduced
substances;

n, Smear is a specimen for microscopic study, the material being spread thinly and
unevenly across the slide with a swab or loop, or with the edge of another slide;

©. Sterilization is the process of exterminating all microorganisms within or outside
an object or material using extreme chemical or physical;

p. Tissue culture refers to a collection of laboratory techniques and methods in which
fragments of a tissue (human, plant or animal tissue) are introduced into a new, artificial
environment, where they continue to function or grow;

Virology is the study of viruses, virus-like agents including but not limited to their
taxonomy, disease-producing properties, cultivation and genetics.

CHAPTER I
VIROLOGY SCIENCE AND TECHNOLOGY
INSTITUTE OF THE PHILIPPINES

Section 4. Creation of a Virology Science and Technology Institute of the Phil
(VIP). - There is hereby created a Virology Science and Technology Institute of the Philippines
(VIP), hereinafter referred to as the Institute.

Section 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.


Section 6. Authority and Responsibility. -

a, 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,

b. The Institute shall be headed by a Director, who shall have a rank of an
‘undersecretary and shall be appointed by the President ofthe Philippines upon the recommendation
of the advisory body. He shall be a qualified virologist possessing @ postgraduate degree in
Virology with three to five years of experience in diagnostic virology. He shall have overall
responsibility forthe activities including the supervision of all the staff working in the Institute, In
‘addition, he 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. He shall also be in charge
of its general institutional affairs, promote research and foster efficient assay and research
activities.

4. The Director shall be assisted by a Deputy Director, who shall have a rank of an
assistant secretary. He shall also be appointed by the President of the Philippines upon the
recommendation of the advisory council.

Section 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
systems for diseases of viral etiology, industrial and technological implications of virology and
services involving the storing and supplying pathogenic and non-pathogenic viral agents and their
Vectors and hosts, standardizing reagents, preparing and supplying reference materials needed for
the diagnosis and surveillance of plant, animal and human diseases, educating professional
technicians, and information exchange;

c. Establish testing, reference and biosafety levels 1, 2 3, and 4 research laboratories
which are fully compliant with the provisions of this Act and the intemationally-accepted
guidelines in the establishment and operation of the same;

d Conduct viral disease surveillance program, collection, analysis, and feedback and
distribution of information on diseases of viral etiology;

¢. _ Comprehensively coordinate the planning and implementation of research projects,
approve liaison and coordination with relevant governmental agencies, and coordinate research
projects with other research institutions;

{£ Provide technical advice to national authorities on the progress, needs and
aspirations of the virology laboratory network in the country and to regulate the operation of the
same;


2 Assist national authorities in the planning, organization and supervision of the
virology laboratory network;

h. Develop technical/training material for use in laboratories in the network to
enhance their quality;

i. Assess the needs and impart training to the staff of other virology laboratories in
the country in quality testing for viral pathogens;

j. Validate reagents and kits that may be used nationally;

k. Validate new technologies that may become available and recommend their
implementation in the country;

1. Develop minimum standards, standard operating procedures and research protocols
for virology laboratories and assist virology laboratories in their implementation of the same;

m. Develop a national database on the laboratory results;

n. Organize external quality assessment schemes to periodically assess the quality of
testing in networks and suggest remedial measures to those laboratories that show poor
performance;

0. Undertake research to improve the quality and cost-effectiveness of virology
laboratory services in the country;

p. Collaborate with the World Health Organization (WHO) and other international
agencies in virology researches and technical matters pertaining to improvement of laboratories;

q. Create within the Institute various divisions that will spearhead basic and applied
molecular biological research and reference activities in arbovirology, emerging and reemerging
viral diseases, neurovirology, herpes virology, enteric virology, tumor virology, hepatitis virology,
acute viral respiratory infections and cytokines, viral genomics and molecular genetics and
biosafety control studies of viruses, among others;

r,  Promulgate rules and regulations regarding the management and operation of
virology laboratories in the country as well as its rules of engagement;

s. Collect fees in connection with the exercise of its regulatory powers;

t. Apply for, receive, and accept bequests, grants, and donation of funds, equipment,

materials and services needed for the attainment of its objectives;

u. Provide grants, research fund, materials and equipment for the conduct of virology
researches by both public and private higher education institutions;

vy. Order the suspension or closure of virology laboratories and prosecution of
individuals and corporations for violations of this Act;

w. Establish an editorial office of a refereed journal of virology to published it and a
library which shall to collect and preserve books, journals and other reference materials in the field
of virology; and

x. Perform such other related activities as may be assigned by the DOST.

Section 8. Organization and Personnel, - The Institute shall have its technical and
administrative support staff as well as consultants as may be necessary. Such consultants may be


drawn from the public and private sectors on consultancy or contractual basis and shall be granted
honoraria or allowances at such amounts as may 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.

Section 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.

Section 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.

CHAPTER IL
VIROLOGY LABORATORY OPERATIONS

Section 11. Physical structure of virology laboratories. - All newly constructed virology
laboratories shall be located in separate, multi-storied buildings.

A virology laboratory shall be situated at the end of a corridor in a building where other
laboratories are located in order to restrict entry of visitors, prevent contamination and facilitate
maintaining biosafety standards.

In cases of existing laboratories, they shall be separated from other areas and facilities that
are open to unrestricted staff movement within the building.

Section 12. Essential features of a virology laboratory. - Apart from the biosafety
requirements, the following shall be the minimum essential features that must to be incorporated
in the design of a virology laboratory:

‘a. Adequate space shall be provided for the safe conduct of laboratory work and for
cleaning and maintenance. Designated cubicles, rooms or areas shall be available to carry out
different activities, e.g. office rooms, specimen collection cubicle, specimen reception and
processing room, serology laboratory, cell culture cubicle, molecular diagnostic laboratory
comprising three cubicles, cold room, dark room for fluorescent microscopy, common equipment
room, media preparation room, washing and sterilization section, store room, toilets and lunch
room;

b. Each laboratory room shall have a space for housing a biosafety level 2 cabinet,
‘one workbench, a sink, discard bins, wall cabinets to store consumables, a centrifuge, an incubator
and a refrigerator;


c. The entire laboratory shall be climate-controlled to maintain a dust-free
environment and an ambient temperature of 22-25 °C. Least cell culture cubicles, virus handling
cubicles, the serology lab and the molecular biology labs shall also be air condition«

d. Walls, ceilings and floors shall be smooth, easy to clean, impermeable to liq
and resistant to chemicals and disinfectants normally used in the laboratory. Floors shall be sli
resistant;

Bench-tops shall be impervious to water and resistant to disinfectants, acids, alkalis,
organic solvents and moderate heat;

f, Illumination shall be adequate for all activities. Undesirable reflections and glare
shall be avoided;

g Laboratory furniture shall be sturdy. Open spaces between and under benches,
cabinets and equipment shall be accessible to cleaning;

h. Storage space shall be adequate to hold supplies for immediate use and thus prevent
clutter on bench tops and in aisles. Additional long-term storage space conveniently located within
or outside the laboratory area shall also be provided;

i. All doors shall have vision panels, appropriate fire ratings and self-closing;

j. Facilities for storing outer garments, personal items, pantry and restrooms shall be
provided outside the laboratory working area;

k. _Hand-washing basins with running tap water shall be provided in each laboratory
room, preferably near the exit door. A dependable supply of good quality water shall essential.
‘There must be no cross-connections between sources of laboratory water supply and drinking
water supplies;

1. There shall be reliable and adequate electricity supply and emergency lighting for
safe exits, A stand-by generator shall be available at least for some equipment such as incubators,
biosafety cabinets, freezers etc.; and

m, Safety systems shall cover fire, electrical emergencies, emergency shower and
eyewash facilities including systems for avoiding overcrowding and too much equipment, pest
control and prevention particularly rodents and arthropods and prevention of unauthorized entry
into the laboratory areas.

Section 13. Equipment and supplies. - The virology laboratory shall have adequate
‘equipment which shall take into account certain general principles, including:

a. The equipment, facilities and supplies must be designed to prevent or limit contact
between the operator and the infectious material (e.g. biosafety cabinets, electronic pipetting aids,
ete.)

b. The equipment and facilities must be made of materials that are impermeable to
liquids, resistant to corrosion and meet intemationally-accepted structural requirements;

¢. The equipment and facilities must be free of sharp edges, burrs and unguarded
moving parts;

4. ‘The equipment and facilities must be designed, constructed and installed to
facilitate simple operation and provide for ease of maintenance, cleaning, decontamination and
certification testing; and


e.  Glasswares and other breakable materials must be avoided wherever possible.
Essential and desirable equipment required for a virology laboratory must conform with standards
set by the Institute and internationally-recognized manuals and guidelines for virology laboratory
operations.

Seetion 14. Biosafety requirements of laboratories. - The biosafety infrastructure shall be
designed on the basis of risk assessment for handling specific pathogens. The desired biosafety
evels shall be established on the basis of professional judgement based on risk assessment and on
internationally-accepted guidelines on the handling and management of specific viral agents.

a. In addition to the minimum essential features stipulated in Section 12, a biosafety
level 2 laboratory shall have the following minimum requirements:

1. _ Inward airflow ventilation or controlled ventilating system;
2. On-site Autoclave: and
3 Biological safety cabinets.
b. _ In addition to the minimum essential features stipulated in Section 12, biosafety

level 3 and 4 laboratories shall have the following minimum requirements:
1 Isolation of laboratory;
z Room sealable for decontamination;

3. _ Inward airflow ventilation, controlled ventilating system and HEPA-filtered

4, Double-door entry;
5. Airlock;
6. Airlock with shower;
7. Anteroom;
8. Anteroom with shower;
9, Effluent treatment;
10. Onsite, in-laboratory and double-ended Autoclave;
11. Biological safety cabinets; and
12. Personal safety monitoring capability.
c. Biosafety level 3 and 4 laboratories must be separated from general traffic flow and
eee essa an anteroom (with double door entry or basic laboratory ~ Biosafety Level 2) or

da ‘An autoclave must available within the facility for decontamination of wastes prior
to disposal.

e. A sink with hands-free operation must available.


£ Inward directional airflow must be established and all work with infectious
materials must conducted within a biological safety cabinet.

Section 15. Handling of viruses and specimens containing viruses. - Unless the
recommended biosafety level facilities are available, the laboratory should not handle a particular
virus, In situations where there is an outbreak of a viral illness and the required biosafety levels
are not available, the specimen shall be collected and referred to the nearest laboratory that has the
required biosafety laboratory. Specimens collected from patients who are suspected of suffering
from viral infections caused by agents under risk groups 3 or 4 shall be directly forwarded to the
reference laboratory or the Institute which has the required facilities for the handling such agents.

Section 16. Minimum staff requirement for a virology laboratory. — The minimum staff
requirements for a virology laboratory shall include:

‘a. A qualified virologist possessing a postgraduate qualification in virology with three
years of experience in diagnostic virology shall be the chief of the laboratory. He shall have overall
responsibility for the activities of the laboratory and shall supervise all the staff working in it. In
addition, he shall be directly responsible for reporting results of the various diagnostic assays
performed in the laboratory;

b. Two junior microbiologists possessing a master’s degree in medical, animal or
plant microbiology with one to two years of experience in diagnostic virology. These
microbiologists shall be responsible for the day-to-day operation of the laboratory including the
supervision of technical staff who carry out the various diagnostic tests, stock management and
procurement of laboratory supplies and diagnostic kits, quality control and quality assurance;

c. Two laboratory technologists possessing a bachelor’s degree in medical
technology, one to be trained in cell culture and virus isolation methods and the other to be trained
in serology. The technicians shall be responsible for specimen processing, testing, laboratory
safety, maintenance of laboratory records and media preparation; and

One or two laboratory supportive staff.

e. The duties and responsibilities of all the staff shall be clearly outlined and 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.

Section 17. Use of personal protective equipment in virology laboratories. - Specially
designed coveralls which afford protection up to the neck, facemasks or full 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.

Section 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.

Section 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.

Section 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.


Section 21. Accidents. —

a, _ Allaccidents 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 staf 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. _ Awell sign-posted standard first aid kit for minor injuries must be in a conspicous
location inside the laboratory; and

4. Standard operating procedures for management of post-exposure prophylaxis must
be in place.

CHAPTER III
LABORATORY WASTE MANAGEMEN’

Section 22. Management of laboratory waste. - Laboratory waste shall be segregated into
colour-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 defence, 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.

Section 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.

Section 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.

Section 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.

Section 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. _Intransporting 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 IV
QUALITY SYSTEMS IN VIROLOGY LABORATORIES

Section 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.

Section 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 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.

Section 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.

Section 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, such as dacron or rayon;

c. Smears, Smears must contain a reasonable number of cells, be of a reasonable size, and
not mixed with blood or pus in order to avoid non-specific staining;


|. Specimens for serology. Excessively haemolyzed, lipaemic, bacterially-contaminated,
or leaking specimens shall be rejected. Sera shall be heat-inactivated depending on the
tests to be performed. In the event of a specimen being rejected, the sender shall be
informed, preferably by an oral report followed by a written one, Extenuating
circumstances may warrant the acceptance of a substandard specimen;

Tissue culture and media. Within a given cell line, there may be significant variations
in sensitivity to virus isolation which may depend on the particular cell line or clone
and the passage number. Information on a particular cell line shall be recorded
accurately including the source, type, passage number, confluency and cell condition.
These back-up systems shall include freezing and storage of low passage cells at -70°C
liquid nitrogen tanks, use of paired stock flasks or carrying of a parallel set of stock
flasks using a separate set of tissue culture reagents and glassware;

Other quality control procedures that may aid in minimizing the risk of contamination
shall include the exclusion of laboratory with infectious diseases from handling tissue
culture, and separate laboratory apparel, reagents and glassware for tissue culture. Cell
lines shall be handled separately and the cabinet shall be decontaminated in between
uses;

Media. Following filter sterilization, aliquots of the media shall be taken and checked
for bacteriological or fungal contamination. These samples shall be examined daily for
five days and must be free from contamination. Aliquots of all other medium
components such as fetal calf serum and L-glutamine shall also be checked. New lots
of medium and fetal calf serum that have passed the sterility check shall be monitored
for their ability to support cell growth;

Reagents and kits. Reagents and kits shall only be ordered from reputable
manufacturers and dealers with reliable transportation systems. Upon receipt, the
reagents shall be checked for obvious breakage or contamination. The quantity, source,
lot number and date of receipt shall be entered in a logbook and the reagents stored
according to the manufacturer's storage specifications. When new lots of any reagent
are opened, the date shall be noted on the container. Caution shall be exercised in the
case of kits as different components of a kit may require different storage conditions
and have different expiration dates; and

. Instruments. Laboratory instruments shall be subjected to routine preventive
maintenance and checked and calibrated on a regular basis. Some of these checks may
be performed by laboratory staff and entered into a logbook. The following shall be the
minimum routine laboratory maintenance and performance checks on instruments:

i, Incubators: daily temperature, CO2 and humidity checks. Weekly
decontamination of interior;

ii, Safety cabinets: daily air pressure check and cleaning of UV lamp. Work
surface should be decontaminated after each use. Annual checks for air velocity and
filter integrity and paraldehyde decontamination, as applicable;

iii, Microscopes: daily cleaning of objectives and stage, log of lamp usage and
annual overhaul. Refrigerators and freezers: daily temperature check; annual check of
compressor and refrigerant levels;

iv. Water baths: daily temperature checks, weekly decontamination;

v. Refrigerated centrifuges: weekly decontamination, annual inspection of
motor, speed calibration and drive system;


vi. Autoclaves: daily temperature check and monthly spore strip testing;

vii. pH meters: single reference buffer check before each use, multiple point
check monthly; and

viii. Pipetting devices: gravimetric volume check monthly; annual overhaul.

Section 31. Continuing professional education. — All virology laboratories shall regularly
provide local and international education and training to its laboratory workers at the expense of
the laboratory.

Section 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

Section 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 V
PENALTY PROVISIONS

Section 34. Penalties. -

a. _ Inaddition 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) of 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
faults or omissions shall be punishable by imprisonment of at least 6 years and 1 day to 12 years
(prision mayor) oF a fine of not less than one hundred thousand pesos (P100,000.00) but not more
than one million pesos (P1,000,000.00), or both, such imprisonment and fine, at the discretion of
the court:

‘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;


¢. 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 correctional) or a fine of not less than one hundred thousand pesos (P100,000.00) but not
more than five hundred thousand pesos (P500,000.00), or both, such imprisonment and fine, at the
discretion of the court:

Any person who operates a virology laboratory in violation of Sections 16, 17, 18,
19, 20 and 21 of this Act.

ji, Any person who operates a virology laboratory in violation of Sections 27, 28, 29,
30, 31, 32 and 33 of this Act;

Section 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.

Section 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 favour of the State.

CHAPTER VI
OTHER PROVISIONS

Section 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.

Section 38. Appropriations. - The sum of Fifty Billion Pesos (Php 50,000,000.000.00) is
hereby appropriated for implementation of the provisions of this Act: Provided, that such
appropriation shall apply only when this Act is passed before the Institute could be given
appropriation under the General Appropriations Act for the nearest upcoming year.

‘Such amounts as may be necessary for the operating expenses of the Institute for the current
calendar year is hereby authorized to be appropriated out of any unappropriated funds in the
National Treasury.

The yearly allocation equivalent to yearly requirement for virology research and operation
of the Institute shall be earmarked under the General Appropriations Act.

Section 39. 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.

Section 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.


Section 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.

Section 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.

Section 43. Effectlvity. — This Act shall take effect fifteen (15) days after its publication
in the Official Gazette or in a newspaper of general circulation.

Approved,