Principles of Medical Laboratory Science 1

COLLEGE OF ALLIED HEALTH PROFESSIONS – UNIVERSITY OF THE EAST RAMON MAGSAYSAY MEMORIAL MEDICAL CENTER INCORPORATED
OUTLINE BIOHAZARD SYMBOL
PRINCIPLES OF BIOSAFETY
BIOHAZARD SYMBOL
CLASSIFICATION OF INFECTIVE MICROORGANISMS
BY RISK GROUP
BIOSAFETY CONTAINMENT LEVELS 4 circles within the symbol, signifies the chain of
BIOSAFETY LEVEL 1 infection.
BIOSAFETY LEVEL 2 Agent
BIOSAFETY LEVEL 3 → Type of microorganism that causes infection or
BIOSAFETY LEVEL 4 hazardous condition
LABORATORY BIOSECURITY Host
5 ELEMENTS OF BIOSECURITY → Organism in which the microorganism infects
THE 8 NEW PILLARS OF LAB BIOSECURITY 2019 Source
RECAP → Host from which the microorganism originates
→ The carrier host might now show symptoms
PRINCIPLES OF BIOSAFETY Transmission
Practice and Procedures → The means of transmission
→ Mostly direct or indirect
→ Standard practices
→ Some routes of transmission include air, insect,
• Most important concept/strict adherence
direct contact, and contaminated surfaces
• Aware of potential hazard
• Trained and proficient in techniques
• Supervisors responsible for appropriate CLASSIFICATION OF INFECTIVE MICROORGANISMS
laboratory facilities, personnel and training BY RISK GROUP
Risk Group 1
→ Special practices and considerations - → No or low individual and community risk
occupational health programs to keep the → A microorganism that is unlikely to cause
safety and health of the health workers human or animal disease
Risk Group 2
Safety Equipment → Moderate individual risk, low community risk
• Primary containment barrier → A pathogen that can cause human or animal
• Minimize exposure to hazard-prevent disease but is unlikely to be a serious hazard to
contact/contain aerosols laboratory workers, the community livestock or
• Engineering controls/equipment the environment
• PPE – gown, gloves, respirator, face shield, → Laboratory exposures may cause serious
booties infection, but effective treatment and preventive
• BSC measures are available and the risk of spread of
• Covered or ventilated area or system infection is limited
Risk Group 3
Facility Design and Construction → High individual risk, low community risk
• Secondary barrier/engineering controls → A pathogen that usually causes serious
• Contributes to worker protection human or animal disease but does not
• Protects outside the laboratory ordinarily spread from one infected individual
• Building and lab design, ventilation, to another
autoclaves, cage, and wash facilities → Effective treatment and preventive measures
are available
Increasing Levels of Protection Risk Group 4
• Biosafety level 1 to 4 → High individual and community risk
→ Pathogen that usually causes human or
animal disease that can be readily
transmitted from one individual to another,
directly or indirectly
→ Effective treatment and preventive measure
are not usually available

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 BIOSAFETY CONTAINMENT LEVELS Safety equipment
→ Levels of the biocontainment precautions • Special containment devices or equipment,
required to isolate dangerous biological agents such as BSCs are not generally required. Can
in an enclosed facility work in an open bench
→ Combination of laboratory practices and • Protective laboratory coats or uniforms are
procedures, safety equipment and laboratory recommended.
facilities • Wear gloves to protect hands from exposure
Biosafety Levels to hazardous materials
→ Each level associated with appropriate
equipment, practices, and work procedures BIOSAFETY LEVEL 2
→ Diagnostic and health-care laboratories must → Designed for laboratories that deal with
be biosafety level 2 or above indigenous moderate-risk agents present in
• Level 1 & 2 – required for basic laboratories the community
• Level 3 – containment laboratories → Practices, equipment and facility design
• Level 4 – maximum containment laboratories applicable to clinical, diagnostic, teaching
laboratories.
→ Microbes that possess moderate hazards to
laboratorians
→ Primary hazards to personnel working with
these agents relate to accidental
percutaneous or mucous membrane
exposures, or ingestion of infectious materials.
→ Example: Hepatitis virus, HIV, Salmonella
enterica spp.
Bsl- 2 Practices
• Standard Microbiological Practices (same as
BSL-1) - should have GMT (good
microbiological techniques)
• Access to laboratory is restricted when
BIOSAFETY LEVEL 1 working is being conducted
→ For undergraduate and secondary educational Safety Equipment
training and teaching laboratories • Properly maintained BSCs (always calibrated)
→ Microbes not known consistently to cause • Personal protective equipment (gloves,
disease in healthy adults and present minimal goggles, mask, face shield) and/or
hazard to lab and environment • Physical containment devices must be used
→ Open bench - No containment especially during procedures with potential for
→ Examples: Non-Pathogenic strain of creating infectious aerosols or splashes are
Escherichia coli, Bacillus subtilis conducted.
Bsl-1 Practices ✓ Example Pipetting, Centrifuging.
• Standard microbiological practices are • High concentrations or large volumes of
followed infectious agents are used
• Work can be performed on an open table or • Autoclave/Decontamination proper
bench • Self-Closing doors
• PPE (Personal Protective Equipment) needed • Sink with eyewash apparatus readily available
Standard Microbiological Practices • A sign incorporating:
• Hand washing practices ✓ Universal biohazard symbol
• Eating, drinking, smoking, handling contact ✓ Laboratory’s biosafety level
lenses applying cosmetics, and storing food ✓ Supervisor’s name, Telephone number
are not permitted in laboratory ✓ Required procedures for entering
• Food must be stored outside the laboratory
area in cabinets or refrigerators designated
and used for this purpose
• Mouth pipetting is prohibited
• Policies for safe handling of sharps must be
implemented

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 BIOSAFETY LEVEL 3 Code Of Practice
✓ Applicable to clinical, diagnostic, teaching, → The two-person rule should apply, whereby no
research individual ever works alone
✓ Serious/potentially lethal disease through → A complete change of clothing and shoes is
respiratory transmission required prior to entering and upon exiting the
✓ Primary hazards – relate to autoinoculation, laboratory
ingestion and exposure to infectious aerosols. → Personnel must be trained in emergency
✓ Example: Mycobacterium tuberculosis, extraction procedures in the event of
Coxiella burnetii, St. Louis encephalitis personnel injury or illness
Bsl-3 Practices → A method of communication for routine and
• Laboratorians – under medical surveillance emergency contacts must be established
and receive immunization between personnel working within the
• Access to laboratory is restricted & controlled maximum containment laboratory – biosafety
• Same as BSL-1 & 2 level 4 and support personnel outside the
• Method for decontaminating all laboratory laboratory
wastes should be available in the facility,
preferably within the laboratory LABORATORY BIOSECURITY
✓ Example: Autoclave, Chemical → Protection, control, and accountability for
disinfection, incineration) valuable biological materials within
Safety Equipment laboratories, in order to prevent their
• all procedures must be conducted within a unauthorized access, loss, theft, misuse,
BSC (preferably class ii or class III), or other diversion, or intentional release.
physical containment devices → There is a potential for malicious use of these
• use protective laboratory clothing with a solid- biological agents
front → Use is valuable for many legitimate and
✓ tie-back or wrap-around gown, scrub benign diagnostic, commercial, medical, and
suits research applications
• eye and face protection → It is essential to properly assess potential
✓ goggles, mask, face shield or another biosecurity risks.
splash guard
• gloves must be worn 5 ELEMENTS OF BIOSECURITY
• PPE with respirators
• biosafety cabinets
• sink with eyewash
• exhaust air – not circulated
• self-closing doors with automatic locking

BIOSAFETY LEVEL 4
→ For working with dangerous and exotic agents → Holistic process
that pose a high individual risk of life- → Objective and the key priority IS the public
threatening disease that may be transmitted health and welfare
via the aerosol route, for which there are no
available treatments or vaccines.
1. Physical Security
→ Highest level of biological safety
→ Assurance of safety from physical
→ Dangerous and exotic microbes
intrusion
→ Example: EBOLA, Marburg Viruses, Crimean-
→ To select, control, and document the
Congo hemorrhagic fever
access to the laboratory and its
Bsl- 4 Practices materials
• Same with BSL-3 → The level of physical security
• Change clothes before entering increases as the value of assets/or
• Shower upon exiting materials inside the containment
• Decontaminate all materials before exiting facility increases
• Class III BSC • Access control
• Separate building for laboratory • Intrusion detection
• Vacuum lines and decontamination systems • Alarm assessment and response

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2. Personnel Security RECAP
→ Assurance that the people who are given → The biosecurity procedures and practices used
access to the biological materials have to secure regulated pathogens at an institution
integrity. Also, the biological materials will not are also required to secure research using
be misused and not be used by any harmful emerging technologies
activities → A laboratory biosecurity program is required
→ Mechanism that will develop to ensure the to prepare, implement, oversee, and review
integrity inside the facility
biosecurity risks, according to the
→ Documents guidelines on how not to
requirements of the facility
compromise the integrity of the facility in the
absence of key individuals of the containment
facility
• Background check
• Periodic investigations
3. Pathogens Security
→ Assurance that there is an awareness in the
laboratory and to know who is accountable for
it
→ One accountable for it
→ Not to detect if biological material is missing
→ Create an environment that will discourage the
theft and misused by establishing oversight.
• Detailed inventory
• Internal/external transfer
• Inactivation and disposal records of
pathogens
4. Information Security
→ Assurance that the sensitive information is
stored in laboratory and is protected from theft
or diversion
• Confidentiality integrity and availability
of information
• Passwords, back-ups
5. Transport Security
→ Assurance that the same processes inside the
laboratory to protect the biological materials
are also followed when this material is
transported outside the laboratory
→ Chain of custody
→ There should be a proper documentation on
what is being transported, who received the
data, time and date that it was transported,
and time and date that it was received.
• 3-way packaging system – “from-how-
where”
• Knowledgeable IATA certified personnel

THE 8 NEW PILLARS OF LAB BIOSECURITY 2019

1. Inventory control
2. Information control
3. Personnel control
4. Physical security control
5. Transport control
6. Emergency response plan
7. Dual use research of concern
8. Emerging biotechnology

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