DR. GLORIA D.

LACSON GENERAL HOSPITAL

#180 National Highway, Castellano, San Leonardo, Nueva Ecija, Philippines
Telephone Number (044) 486-2432 / Fax Number (044) 486-2432
Mobile Number: 0965-150-8659
E-mail Address: [email protected]
Institution/Facility name DR. GLORIA D. LACSON GENERAL HOSPITAL
Laboratory name DGDLGH LABORATORY DEPARTMENT
Laboratory manager/Supervisor SYL CRISTABERT T. FIESTA. RMT
Project titles/Relevant standard operating CLINICAL LABORATORY BIOSAFETY MANUAL
procedures (SOPs)
Date MARCH 5, 2024

1. Describe the biological agents and other potential hazards (for example, transmission, infectious dose,
treatment/preventive measures, pathogenicity).
1.1. Aerosol: Liquid or solid particles suspended in air and of a size that may allow inhalation into the
lower respiratory tract (usually less than 10 micrometres in diameter).
1.2. Aerosol/airborne transmission: The spread of infection caused by the inhalation of aerosols.
1.3. Biological agent: A microorganism, virus, biological toxin, particle or otherwise infectious
material, either naturally occurring or genetically modified, which may have the potential to cause
infection, allergy, toxicity or otherwise create a hazard to humans, animals, or plants.
Droplets: A suspension of particles, normally defined as more than 10 micrometres in diameter,
which tends to fall out of the air resulting in contamination of nearby surfaces.
1.4. Exposure: An event during which an individual comes in contact with, or is in close proximity to,
biological agents with the potential for infection or harm to occur. Routes of exposure can include
inhalation, ingestion, percutaneous injury and absorption and are usually dependent upon the
characteristics of the biological agent. However, some infection routes are specific to the
laboratory environment and are not commonly seen in the general community.
1.5. Hazard: An object or situation that has the potential to cause adverse effects when an organism,
system or (sub) population is exposed to it. In the case of laboratory biosafety, the hazard is
defined as biological agents which have the potential to cause adverse effects to personnel and/or
humans, animals, and the wider community and environment. A hazard does not become a “risk”
until the likelihood and consequences
of that hazard causing harm are taken into account.
1.6. Pathogen: A biological agent capable of causing disease in humans, animals or plants.
1.7. Sharps: Any device or object that is a puncture or wound hazard because of its pointed ends or
edges. In the laboratory, sharps can include needles, syringes with attached needles, blades,
scalpels or broken glass.
1.8. Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-COV-2) : a virus responsible for
the 2019 Coronavirus disease (COVID-19). It is a disease-causing human pathogen.
1.9. COVID-19 Pandemic : also known as the coronavirus pandemic, is an ongoing global pandemic
of coronavirus disease 2019 (COVID19), caused by severe acute respiratory syndrome coronavirus
2 (SARSCoV2). The outbreak was first identified in December 2019 in Wuhan, China. The World
Health Organization declared the outbreak a Public Health Emergency of International Concern on
30 January 2020 and a pandemic on 11 March. As of 31 August 2020, more than 25.3 million
cases of COVID19 have been reported in more than 188 countries and territories, resulting in more
than 848,000 deaths; more than 16.6 million people have recovered.
1.10. COVID 19 Transmission: The virus is spread primarily via nose and mouth secretions
including small droplets produced by coughing, sneezing, and talking. The droplets usually do not
travel through air over long distances. However, those standing in close proximity may inhale
these droplets and become infected. People may also become infected by touching a contaminated
surface and then touching their face. The transmission may also occur through smaller droplets
that are able to stay suspended in the air for longer periods of time in.
1.11. Blood-borne viruses (BBVs): are viruses that some people carry in their blood and can be
spread from one person to another. Those infected with a BBV may show little or no symptoms of
serious disease, but other infected people may be severely ill. You can become infected with a
virus whether the person who infects you appears to be ill or not – indeed, they may be unaware
they are ill as some persistent viral infections do not cause symptoms. An infected person can
transmit (spread) blood-borne viruses from one person to another by various routes and over a
prolonged time period.

1. Describe the laboratory procedures to be used (for example, culturing, centrifugation, work with
 DR. GLORIA D. LACSON GENERAL HOSPITAL
#180 National Highway, Castellano, San Leonardo, Nueva Ecija, Philippines
Telephone Number (044) 486-2432 / Fax Number (044) 486-2432
Mobile Number: 0965-150-8659
E-mail Address: [email protected]
sharps, waste handling, and frequency of performing the laboratory activity).
1.1. Microbiological Culture, Or Microbial Culture, is a method of multiplying microbial
organisms by letting them reproduce in predetermined culture medium under controlled
laboratory conditions.
All specimens subjected for culture were processed in a Biosafety Cabinet level 2.
1.2. Centrifugation is a mechanical process which involves the use of the centrifugal force to
separate particles from a solution according to their size, shape, density, medium viscosity and
rotor speed.
1.2.1. Blood, urine and other body fluids for processing are subjected for centrifugation.
1.3. Aseptic techniques: Conditions and procedural measures designed to effectively prevent
contamination.
1.4. Containment: The combination of physical design parameters and operational practices that
protect personnel, the immediate work environment and the community from exposure to
biological agents.
1.5. Decontamination: Reduction of viable biological agents or other hazardous materials on a
surface or object(s) to a pre-defined level by chemical and/or physical means.
1.6. Disinfectants: Agents capable of eliminating viable biological agents on surfaces or in liquid
waste. These will have varying effectiveness depending on the properties of the chemical, its
concentration, shelf life and contact time with the agent.
1.7. Disinfection: A process to eliminate viable biological agents from items or surfaces for further
safe handling or use.
1.8. Inactivation: Removal of the activity of biological agents by destroying or inhibiting
reproductive or enzyme activity.
1.9. Prophylaxis: Treatment given to prevent infection or to mitigate the severity of the disease if
infection were to occur. It can be delivered before possible exposure or after exposure before the
onset of infection.
1.10. Sterilization using AUTOCLAVE: A process that kills and/or removes all biological
agents including spores.
1.11. Triage area: The sorting out and classification of patients or casualties to determine
priority of need and proper place of treatment. During infectious disease outbreaks, triage is
particularly important to separate patients likely to be infected with the pathogen of concern.
This triage SOP is developed in the context of the COVID-19 pandemic and does not replace any
routine clinical triage already in place in healthcare facilities to categorize patients into different
urgency categories. No facemask/faceshield No ENTRY, Sanitize before you enter, Observe
Social Distancing are strictly implemented in the triage area.

2. Describe the types of equipment to be used (personal protective equipment (PPE),centrifuges,

autoclaves, biological safety cabinets(BSCs)).
2.1. Biological safety cabinet (BSC): An enclosed, ventilated working space designed to provide
protection to the operator, the laboratory environment and/or the work materials for activities
where there is an aerosol hazard.
2.1.1. BIOSAFETY CABINET LEVEL 2 is used by the facility. Containment is achieved by
segregation of the work from the main area of the laboratory and/or through the use of
controlled, directional airflow mechanisms. Exhaust air is passed through a high efficiency
particulate air (HEPA) filter before recirculating into the laboratory or into the building’s
heating, ventilation and air conditioning system.
2.2. Personal protective equipment (PPE): Equipment and/or clothing worn by personnel to
provide a barrier against biological agents, thereby minimizing the likelihood of exposure. PPE
includes, but is not limited to, laboratory coats, gowns, full-body suits, gloves, protective
footwear, safety glasses, safety goggles, masks and respirators.
2.2.1. All healthcare personnel adhere to Standard Precautions, which includes hand hygiene,
selection of PPE, respiratory hygiene, cleaning and disinfection safety practices.
2.2.2.A fit N-95 mask is used.
2.2.3.Personnel are using double gloves, long sleeve fluid resistance laboratory gown and face
shield.
2.3. Standard infection control precautions were adhered by all staff in every patient encounter at all
times. Supplies for respiratory hygiene and cough etiquette must be available always at the triage
area such as 70% alcohol, tissues and face masks.
2.3.1.Decontamination: 1:10 dilution of bleach (atleast 10-15 mins. Contact time), followed by
 DR. GLORIA D. LACSON GENERAL HOSPITAL
#180 National Highway, Castellano, San Leonardo, Nueva Ecija, Philippines
Telephone Number (044) 486-2432 / Fax Number (044) 486-2432
Mobile Number: 0965-150-8659
E-mail Address: [email protected]
70% alcohol was implemented.
2.3.2.Used swab were soaked immediately in 3-5% Lysol for atleast 30 mins. Prior autoclaving.
2.3.3.PPEs were autoclaved prior to disposal.

3. Describe the type and condition of the facility where work is conducted.
3.1. Triage and waiting area has 70% alcohol or disinfectant.
3.2. A physical barrier made of glass or plastic were placed in order to separate healthcare personnel
and possible infectious patients to restrict close contact.
3.3. Proper signage were placed at the entrance of the facility to direct patients about the proper
protocol once entering the facility
3.4. Donning and doffing area were noted.
3.5. Designated areas for testing were well lighted and spacious.
3.6. Areas where tests are conducted have designated sinks with adequate supply of clean water.
3.7. Designated areas for testing were designed for easy access of supplies, first aid and biological
spill response kit.
3.8. Eye wash area is accessible.

4. Describe relevant human factors (for example, competency, training, experience and attitude of
personnel).
4.1. All healthcare personnel of the facility are trained on and familiar with infection prevention and
control.
4.2. Biosafety and Biosecurity training certificate is a requirement for personnel.

Potential situations in which exposure or Likelihood of an exposure/release occurring

release could occur · Unlikely: not very possible to occur in the
near future.
· Possible: feasible to occur in the nea rfuture
· Likely: very possible to occur in the near future.
Spills and Improper handling of specimens. Likely
Defects on PPE Possible
Not wearing of PPES properly. Likely
Not well protected OR not well ventilated Possible
swabbing area
Low competency of personnel conducting Possible
the work
Centrifugation were aerosols were Possible
produced
Improper recapping of needles or improper Likely
disposal of needles
Inadequate or poor availability of electrical Possible
power and malfunctioning equipment
Low infectious dose Possible
High communicable disease Possible
Limited availability of prophylaxis Possible
High concentration or volume of biological Likely
agent
Airborne route of transmission of the Likely
 DR. GLORIA D. LACSON GENERAL HOSPITAL
#180 National Highway, Castellano, San Leonardo, Nueva Ecija, Philippines
Telephone Number (044) 486-2432 / Fax Number (044) 486-2432
Mobile Number: 0965-150-8659
E-mail Address: [email protected]
disease

What is the severity of the All staffs are fully vaccinated and following safety
consequences of an exposure/release protocols. Sufficient supplies of PPEs are ensured and well-
(negligible, moderate, severe)? ventilated swabbing area is provided with area of donning
and doffing as well. Therefore, there’s a moderate severity
of consequences of an exposure.

ASSESSING INITIAL RISK

Likelihood of exposure/release
Unlikely Possible Likely
Consequence of Severe Medium High Veryhigh
exposure/ Moderate Low Medium High
release Negligible Very low Low Medium

Laboratory activity/procedure Initial risk Is the initial risk Priority

(very low, above the tolerance (high/medium/low)
Low, level?
medium, high, (yes/no)
very high)
Swabbing of patient Very high Yes High
Blood Extraction of Patient Very high Yes High
Transfer of Specimens to Medium No Medium
Laboratory working area
Centrifugation of specimen High Yes High
Testing of blood specimen for High Yes High
Blood-borne viruses
Smear preparation and microscopy High Yes High
of sputum specimen
Culture in small quantities (< 50 Medium No Medium
mL) for strain characterization
including antibiotic resistant strains
Culture on solid media for antibiotic Medium No Medium
sensitivity testing
Disposal of sharps High Yes High
Disposal of used PPEs, test High Yes High
kits,Buffer
Select the overall initial risk. ☐ ☐ ☐ ☐ ☐
Very low Low Medium High Very high
Should work proceed
Without additional risk control ☐ Yes ☐No
measures?

Describe the measures required by national Biosafety,Biosecurity and Biorisk management-RITM

legislation or regulations (if any).
Describe the measures advised by guidelines, N/A
policies and strategies (if any).
Are resources sufficient to secure and Yes. The hospital management makes sure to have
maintain potential risk control measures? sufficient supplies of PPEs and disinfectants needed.
Training and seminar for all the personnel regarding
control measures were provided.
What factors exist that may limit or restrict any Untrained and lack of knowledge Medical
of the risk control measures? technologist, may limit any of the risk control
 DR. GLORIA D. LACSON GENERAL HOSPITAL
#180 National Highway, Castellano, San Leonardo, Nueva Ecija, Philippines
Telephone Number (044) 486-2432 / Fax Number (044) 486-2432
Mobile Number: 0965-150-8659
E-mail Address: [email protected]
measures. Lack of rule and non-restrictive protocol
implementation as well.
Will work be able to proceed without any of No, risk controls measure is very important to ensure
the risk safety of staffs.
control measures; are there alternatives?

ASSESSING RESIDUAL RISK

Laboratory Selected risk control Residual risk Is the Are risk
activity/procedure measure(s) (very low, residual control
low, medium, risk above measures
high, very the available,
high) tolerance effective and
level? sustainable?
(yes/no) (yes/no)
Swabbing of patient Wearing of PPE, Low No Yes
following preventive and
control measures, proper
donning.
Blood Extraction of Patient Wearing of PPE, Low No Yes
following preventive and
control measures,
perform proper
phlebotomy.
Transfer of Specimens to Wearing of PPE, Very Low No Yes
Laboratory working area following preventive and
control measures, proper
handling of specimen.
Centrifugation of specimen Wearing of PPE, Very Low No Yes
following preventive and
control measures, proper
handling of specimen.
Testing of blood specimen for Wearing of PPE, Low No Yes
Blood-borne viruses following preventive and
control measures, proper
handling of specimen.
Smear preparation and Wearing of PPE, Very Low No Yes
microscopy of sputum following preventive and
specimen control measures, proper
handling of specimen.
Good microbial practice
and procedure.
Culture in small quantities (< Wearing of PPE, Very Low No Yes
50 mL) for strain following preventive and
characterization including control measures, proper
antibiotic resistant strains handling of specimen.
Good microbial practice
and procedure.
Culture on solid media for Wearing of PPE, Very Low No Yes
antibiotic sensitivity testing following preventive and
control measures, proper
handling of specimen.
Good microbial practice
and procedure.
Disposal of sharps Wearing of PPE, Low No Yes
following preventive and
control measures, proper
waste management,
 DR. GLORIA D. LACSON GENERAL HOSPITAL
#180 National Highway, Castellano, San Leonardo, Nueva Ecija, Philippines
Telephone Number (044) 486-2432 / Fax Number (044) 486-2432
Mobile Number: 0965-150-8659
E-mail Address: [email protected]
autoclaving/ sterilization
before disposing.
Disposal of used PPEs, test Wearing of PPE, Low No Yes
kits,Buffer following preventive and
control measures, proper
waste management
autoclaving/ sterilization
before disposing.
Likelihood of exposure/release
Unlikely Possible Likely
Severe Medium High Veryhigh
Consequence of
Moderate Low Medium High
exposure/release
Negligible Very low Low Medium

Overall residual risk: ☐ ☐ ☐ ☐ ☐

Very low Low Medium High Veryhigh
Should work proceed with selected Risk ☐ Yes ☐No
control measures?
Approved by(Name and title) Syl Cristabert T. Fiesta, RMT
Approved by(Signature)
Date March 5, 2024

Communication of the hazards, risks and  COVID-19 education to all staff.

risk Control measures  Measures to reduce risk of infection from COVID-19
and to minimize contact rate should be implemented.
 A COVID 19 management plan shall be designed that
includes patient flow, triage, extraction, treatment.
Layout shall be designed to allow for unidirectional
movement in aisles or corridors.
 Safety protocols for clinical laboratory should be
available.
 Before entering the laboratory, ensure that there are
adequate supplies of laboratory equipment and
consumables, including reagents, PPE and disinfectants,
and that these items are suitable for the activities
envisaged.
 Ensure proper labeling of all biological agents and
chemical and radioactive material.
 Protect written documents from contamination using
barriers (such as plastic coverings), particularly those
that may need to be removed from the laboratory.
 Ensure that the work is performed with care and without
hurrying. Avoid working when fatigued.
 Keep the work area tidy, clean and free of non-essential
objects and materials.
 Use good techniques to minimize the formation of
aerosols and droplets when manipulating specimens.
This includes refraining from forcibly expelling
substances from pipette tips into liquids, over-vigorous
mixing, and carelessly flipping open tubes. Brief
centrifuging of mixed tubes before opening can help
move any liquid away from the cap.
 Avoid introducing loops or similar instruments directly
into an open heat source (flame) as this can cause spatter
of infectious material.
 Wear disposable gloves at all times when handling
specimens known or reasonably
expected to contain biological agents. Disposable gloves
 DR. GLORIA D. LACSON GENERAL HOSPITAL
#180 National Highway, Castellano, San Leonardo, Nueva Ecija, Philippines
Telephone Number (044) 486-2432 / Fax Number (044) 486-2432
Mobile Number: 0965-150-8659
E-mail Address: [email protected]
must not be reused.
 Proper waste management should strictly implemented
and followed
Purchase(and budgeting)of risk control Highly demand materials for risk control measures should be
measures purchased immediately (e.g. PPES, disinfectants) stocks should
be sufficient. Twice a week monitoring of stocks is
implemented.
Operational and maintenance procedures  DGDLGH Biosafety and Biosecurity Manual
 Standard Operating Safety and Health Program in
Compliance with DTI and DOLE Interim Guidelines on
Workplace Prevention and Control of COVID-19.
 WHO Biosafety manual

Training of personnel Biosafety, Biosecurity and Biorisk management training-RITM

REVIEW RISKS AND RISK CONTROL MEASURES

Frequency of the review Every 6 months
Person to conduct the review Pathologist
Chief Medical Technologist/ Biosafety Officer

Describe updates/changes  Reduce risk of infection and exposure.

 Staffs become knowledgable, more strategic
and following control measures.
 Lesser incident reports.
Personnel/procedures to implement the changes Pathologist
Chief Medical Technologist/ Biosafety Officer

Reviewed by(Name and title) MARJAY S. GULAPA, MD, DPS (PATHOLOGIST)

Reviewed by(Signature)
Date March 5, 2024