Republic af the Philippines
House of Representatines
Quezon City, Metro Manila
Nineteenth Congress

First Regular Sessjan, 0
HOUSE BILL NO.*!4

Introduced by Rep. Anthony R.T. Golez Jr. MD, MBAH

EXPLANATORY NOTE

‘This bill seeks to create the Virology Science and Technology Institute of the
Philippines, a national virology laboratory, which will act as the center for surveillance,
diagnosis and monitoring of viral diseases in humans, plants and animals. The Virology
Science and Technology Institute of the Philippines will also seek to understand genetic
changes in the viral genome to ensure a strong public health response to viral diseases.
In this manner, this representation sees the improvement of the health of Filipinos that
will also lead to improving the social, economic and cultural conditions of the country

‘The need for a national virology laboratory came about with the re
19 pandemic. This pandemic exposed the unpreparedness of everyone in the world in
handling viral diseases. This matter led to unemployment and regression of economic
growth opportunities. More grievous is that the CCOVID-19 pandemic ted to families
losing loved ones.

In the Philippines, the impact of the COVID-19 pandemic is still visible. The
establishment of a national virology center is seen to be a great step towards
preparedness in events like a pandemic. The Virology Science and Technology Institute
of the Philippines will ensure that Filipinos will be prepared on threats of diseases or
events similar to the COVID-19 pandemic.

At this point it is worth-noting the importance of health as enshrined in the
Constitution, to with ~ “The State shail protect and promote the right to health of the people
and instill health consciousness auiong them.”

Approval of this bill is earnestly sought

,
HON. ANTHONY R.T. aa JR. MD, MBAH

Malasakit at Bayanifan Party List



Republic of the Philippines
‘House of Representatives
Quezon City, Metro Manila
Nineteenth Congress
First Regular Session
HOUSE BILL NO. 17:6

Introduced by Rep. Anthony R.T. Golez Jr. MD, MBAH

AN ACTROVIDING 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:
CHAPTER |
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 io 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 establishmeut 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.

Sec. 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


0)

(3)

personnel’s risk of exposure to a potentially infectious microbe and limit

contamination of the work environment and ultimately the community;

Biosafety levels are divided into four (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 mediwn or gr

of microorganisms;

Disinfection the process using chemical compounds to exterminate

microorganisms but does not necessarily kill all microorganisms especially

resistant bacterial spores;

Infectious roaste 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 direetly 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 atienuated vaccines. Cultures and stocks must be
treated in the same way as biological waste.

iit. 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 docs
not include tecth 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.

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, compiete 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.

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
dlood or airborne high infections, it shall also include face protection, goggles and
masks or faces shields, gloves or coveralls, head cover and rubber boots;

oth mediunt is a liquid or gel designed to support the growth



(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 (AAY) types 1-4). These viruses shall
be studied in basic virology laboratories;

(i) 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 vims (HIV), hepatitis B vims (HBV), hantavin
Japanese encephalitis vims (JEV), rabies, rift valley fever and yellow fever vim:

(I) 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) Serologiy 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;

(0) 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;

(q) Virology is the study of viruses, vims-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

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,
animais 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 Institttte 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 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 shal! 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 afiairs, 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
stant secretary, and shall be appointed by the President of the Philippines upon the
ry Bouncil

ass
recommendation of the Adv

Sec. 7. Powers and Functions. - The Institute shail be the principal laboratory of
the country in providing quality virology laboratory investigations, rescarches 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 internationally-
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;

(c) 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;

(f) 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;

(g) Assist national authorities in the planning, organi
virology laboratory network;

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

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

(i) Validate reagents and kits that may be used nationally;

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

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

({m) Develop, in consultation with the DOH, DA, other relevant government agencies,
the academe, and private enterprises engaged in the industry of virology, a national
database of viruses and 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 ons 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 genctics and biosafety control studies of viruses,

tion and supervision of the



among others;

(2) 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;

() 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;

(v) 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.

Sec. 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.

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;

(©) The Secretary of Agriculture, Co-Chairman; and

(4) 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.

A virology laboratory shall be situated at the end of a corridor in a building
where other laboratories are located im 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,

Sec. 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 iaboratory
(a) Adequate space shall be provided for the safe conduct of laboratory work and for

cleaning and maintenance. Designated cubicles, rooms of 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;

() 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 conditioned;

(2) Walls, ceilings and floors shall be smooth, easy to clean, impermeable to liquids
and resistant to chemicals and disinfectants normally used in the laboratory
Floors shall be slip- resistant;

(ec) Bench-tops shall be impervious to water and resistant to disinfectants, acid
alkalis, organic solvents and moderate heal;

(8 Mumination 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;

() 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;



(I) There shall be reliable and adequate electricity supply and emergency
safeexits. 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

Sec. 13. Equipment and supplies. - The virology laboratory shall have adequate
equipment which shall take into account certain general principles, inclucin

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

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

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

(d) The equipment and facilities must be designed, constructed and installed to
facilitate simple operation and provide for case of maintenance, cleaning,
decontamination and certification testing; and

(c) Glasswares and other breakable materials must be avoided wherever possible
Fssential and desirable equipment required for a virology laboratory must conform

standards set by the Institute and internationally-recognized manuals and

guidelines for virology laboratory operations

Sec. 14. Biosafety requirements of laboratories. - The biosafety infrastructure
shall be designed on the basis of risk assessment for handling specific pathogens. The
desired biosaicty levels 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) _Inaddition to the minimum essential features stipulated in Section 12, a biosafety
level 2 laboratory shall have the following minimum requirements:

1. Inwaret airflow ventilation or controlled ventilating system
2. Onsite 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:
solation of laboratory

Room sealable for decontamination;

Inward airflow ventilation, controlled ventilating system and HEPA-filtered;
Double-door entry;

Airlock;

Airlock with shower;

Anteroom;

Anteroom with shower;

Effluent treatment;
10. On site, inlaboratory and double-ended Autociav

ye

SO NM Be



11. Biological safety cabinets; and
12. Personal safety monitoring capability.

(©) Biosafety level 3 and 4 laboratories must be separated from general traffic flow and
accessed through an anteroom (with double door entry or basic laboratory -
Biosafety Level 2) or an airlock.

(d) An autoclave must available within the facility for decontamination of wastes prior
to disposal.

(&) A sink with hands-free operation must available.

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

Sec. 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 Jevels 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.

Sec. 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 of 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;

(©) 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

(d) 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.

Sec. 17. Use of personal protective equipment in virology laboratories. -
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 stalf clothing must be available outside but near the laboratory rooms.
Pantry/rooms for eating and drinking, must be provided close to laboratory room’

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 involyed in continued employment in the
virology laboratory must also be done.

See. 20. Medical surveillance. - system that records and follows up all cases of
among laboratory staff to ascertain the source of infection and initiate any
follow-up action shall be developed

Sec. 21. Accidents. -

fa} 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 statf 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 i
conspicuous location inside the laboratory: and

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

juries must be ma

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 houschold 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

()_ Incineration involves the transport of waste materials off-site for disposal using
an incinerator.



(4) Other internationaily-accopted forms of disinfection and decontamination shall be
employed in effectively preventing, accidents and contamination

See. 23. Infections 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.

See. 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, Internationaily-accepted
altemative means of decontamination to autoclaving or incineration may be used,
provided they are effective.

See. 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.

See. 26. Labelling of waste

(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-cxposure 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 ta minimize the need to transport
contaminated wastes around laboratories

CHAPTER V
QUALITY SYSTEMS IN VIROLOGY LABORATORIES

Sec. 27. Quality systems. - A quality system shail 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 gencration of quality reports by the laboratory. It shal! 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 shail 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 shail 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 shalll 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 shail be instituted to ensure that up-to-date document are
used

Sec. 30. Quality control checks areas.
minimum critical quality control cheek areas
(a) Specimen transport. Viral specimens held for short periods shall be
frigerated, while those for longer periods shall be frozen at -20°C or -70°C;

‘Transport media, The composition and type of viral transport media can affect
viral isolation rates. Culture media shal! be a balanced isotonic solution at
physiological pl, 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;

(c) Siwars. Smears must contain a reasonable number of cells, be of a reasonable
size, and not mixed with blood or pus in order toavoid non-specific staining:

(d) 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 shail be informed, preferably by an oral
report followed by a written one. Extenuating circumstances may warrant
the acceptance of a substandard specimen;

(e) Tissue culture and media. Within a given cell line, there may be significant
variations in sensitivity to vims 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

‘The following, among others, shall be the

(b)



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;

(f) Media. Following filter sterilization, aliquots of the media shail 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;

(g) 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 componenis of a kit may require different storage conditions and
have different expiration dates; and

(a) 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 termperature, C02 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
ge 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. Autociaves: 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 month!
overhaul

; annual

Sec. 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.


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 - 1QAS)
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 vears and 1
day to 20 years (rechesion temporal) or a tine of not less than five hundred thousand
pesos (P500,000,00) but not more than five million pesos (P3,000,000.00), or both,
such imprisonment and fine, at the discretion of the court

i. Any person who introduces high-risk viral pathoge
environment without obtaining a permit, in violation Section
Act.

ji. Any person who refuses, interferes with, or evades an inspection for the
safety control of high-risk viral pathogens;

iii, Any person who negiects 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 (prisiet mayor) or 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:

i. Any person who operates a virology laboratory in violation of Sections 1,
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;

(0) In addition to acts or omissions already penalized by existing laws, the following
faults or omissions shal! be punishable by imprisonment of at least 6 months and 1
day to 6 years ') or a fine of not less than one hundred thousand
pesos (P1 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.

into the domestic
nf this



ji, 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 shal! 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.

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 (2) 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 shail 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. — lf 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.


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,