LABORATORY SAFETY Flashcards
It includes all the information for contact tracing and the information
of the patient, travel information, symptoms of the patient, and chain
of custody
Client Information
Form or Test request
identifiers for the patient
Patient’s full name
Age/Birthday – most likely
Patient’s accession number
Must not have any leaks
− The swab should be included inside the vial
Sample Integrity
True or false
In RITM Interim guidelines for biosafety, there is unidirectional flow of
samples which is always be from clean to dirty.
True
Is a liquid that is usually used to preserve samples until it reaches
the laboratory.
Viral transport medium
Often called as the optimization or validation of methods
choice of analytical method
This is about how we analyze the sample itself.
analytical method
It is the process of removing the genetic material from the cells such as
those from viral or infected cells
Extraction
this is a test tube rack that can be placed in the
freezer and changes color when its cold. This is where the tubes with
samples are placed.
Isofreeze racks
Quality controls such as sterile/blank control, positive control, and
negative controls that are incorporated whenever we do molecular
analysis
Quality Assessment
Quality Assessment used to test whether the reagent is sterile
blank
Quality Assessment used to confirm if the procedure is able to detect
the positive or the targeting RNA
Positive control
negative should be not detected
Negative control
Storage temp requirement
-20°C
Laboratory Workflow
Pre analytical, analytical, post analytical
Are always written and always documented, similarly laws inside the
laboratory that must be followed by all the staff to ensure that all of your
results are released accurately, precisely, and of the best quality.
STANDARD OPERATING PROCEDURE
Encompasses all activities performed by laboratory personnel to
ensure reliability of test results
quality assurance
Quality control checks inside the laboratory, where we run samples with
negative and positive control, and a sterilized control
internal quality assurance
Wherein we test different laboratories with each other, Performed by a National Reference Laboratory (NRL)
external quality assurance
Given to a laboratory before they are given a license to operate or renew
their license
Tests the laboratory if it can work properly or the results are correct and
accurate
proficiency testing
is the entry point of all the laboratory workers and it is where
the lockers are located
Anteroom
Donning area on the right is usually the clean areas, it is also called
positive pressure areas
Donning area on the left is usually the dirty areas, it is also called
negative pressure areas
helps in the transfer of
samples or reagent from one section of the lab to another.
passbox
Receiving room, Specimen processing room, Specimen
Handling/Preparation room are done in
negative pressure area
Reagent preparation room, template adding room, PCR
room are in the
positive pressure areas
→ Potential that a chosen action will lead to an undesirable outcome
→ Probability of harm from occurring given a specific situation
a. hazard
b. risk
risk
→ Has the potential for causing harm
a. hazard
b. risk
hazard
Effect of uncertainty expressed by the combination of the consequences
of an event (including changes in circumstances) and the associated
likelihood of occurrence, where biological materials is the source of harm
a. biohazard
b.biorisk
c. biorisk management
d. risk
biorisk
Management system of part of a management system used to establish
biorisk management policies, objectives, and processes to achieve those
objectives
Biorisk Management System
Containment principles, technologies, and practices implemented to
prevent unintentional/accidental exposure to pathogens and toxins, or
their unintentional/accidental release.
a. Laboratory Biosafety
b. Laboratory Biosecurity
Laboratory Biosafety
Protects bad bugs from bud people
Laboratory Biosecurity
purpose of Biosecurity
- Protect users
- Protect those outside the lab
- Protect the environment
signed by President Corazon C. Aquino.
− This EO creates national committee on Biosafety of the
Philippines.
- Executive Order no. 430 s. 1990
- Proclamation no. 526, s. 1995
- Philippine National Policy Statement on Modern Biotechnology (2001)
- Executive Order no. 247, s. 2003
- Executive Order no. 514, s. 2006
Executive Order no. 430 s. 1990
Constituting the various biotechnology institutes within the
University of the Philippines system as the network of national
institutes of biotechnology, and designating said network as
national center of excellence in molecular biology and
biotechnology, signed by President Fidel V. Ramos
- Executive Order no. 430 s. 1990
- Proclamation no. 526, s. 1995
- Philippine National Policy Statement on Modern Biotechnology (2001)
- Executive Order no. 247, s. 2003
- Executive Order no. 514, s. 2006
Proclamation no. 526, s. 1995
Shall promote the safe and responsible use of modern
biotechnology and its products as one of several means to
achieve and sustain food security, equitable access to health
services, sustainable and safe environment, and industry
development.
1. Executive Order no. 430 s. 1990
2. Proclamation no. 526, s. 1995
3. Philippine National Policy Statement on Modern Biotechnology (2001)
4. Executive Order no. 247, s. 2003
5. Executive Order no. 514, s. 2006
Philippine National Policy Statement on Modern Biotechnology (2001)
Prospecting of biological and genetic resources shall be
allowed within the ancestral lands and domains of indigenous
cultural communities only with the prior informed consent of
such communities.
- Executive Order no. 430 s. 1990
- Proclamation no. 526, s. 1995
- Philippine National Policy Statement on Modern Biotechnology (2001)
- Executive Order no. 247, s. 2003
- Executive Order no. 514, s. 2006
Executive Order no. 247, s. 2003
Establishing the National biosafety framework, prescribing
guidelines for its implementation, strengthening the national
committee on biosafety of the Philippines, and for other purposes.
- Executive Order no. 430 s. 1990
- Proclamation no. 526, s. 1995
- Philippine National Policy Statement on Modern Biotechnology (2001)
- Executive Order no. 247, s. 2003
- Executive Order no. 514, s. 2006
Executive Order no. 514, s. 2006
Guidelines and strengthens the National Committee on Biosafety
of the Philippines.
On March 17, 2006, signed by President Gloria MacapagalArroyo
Executive Order no. 557, s. 2006
Executive Order no. 515, s. 2006
Executive Order no. 514, s. 2006
Executive Order no. 510, s. 2006
Executive Order no. 514, s. 2006
On October 15, 1990, signed by President Corazon C. Aquino.
− This EO creates national committee on Biosafety of the
Philippines
Executive Order no. 433s. 1990
Executive Order no. 430s. 1990
Executive Order no. 431s. 1990
Executive Order no. 403s. 1990
Executive Order no. 430s. 1990
FOUR BASIC PRINCIPLES OF BIOSAFETY
Practices and Procedures
Equipment Safety
Facility and Design Construction
Increasing Levels of Protection
Most important concept/strict adherence
Standard Microbiological Practices
Secondary barrier/engineering controls
Facility and Design Construction
Primary containment barrier
Equipment Safety
Combination of laboratory practices and procedures, safety equipment
(primary barriers) and laboratory facilities (secondary barriers)
Increasing Levels of Protection
→ Used for teaching and research
→ Example: Laboratories in Lourdes Building
Biosafety level ?
Biosafety Level 1
Usually clinical laboratories and research laboratories that
experiment on riskier pathogens
Primary health
services;diagnostic services, research
Biosafety Level 2
Usually clinical laboratories and research laboratories that
experiment on riskier pathogens
Primary health
services;diagnostic services, research
Biosafety Level 2
Special
diagnostic services, research
Biosafety
Level 3
Risk groups are used in Risk Management. true or false
False it should be risk assessment
Biosafety levels are used in Risk Management, true or false
True
A microorganism that is unlikely to cause human or animal
disease.
Risk Group 1 (no or low individual and community risk)
A pathogen that can cause human or animal disease but is
unlikely to be a serious hazard to laboratory workers, the
community, livestock or the environment. Laboratory exposures
may cause serious infection, but effective treatment and
preventive measures are available and the risk of spread of
infection is limited.
Risk Group 2 (moderate individual risk, low community risk)
A pathogen that usually causes serious human or animal disease
but does not ordinarily spread from one infected individual to
another. Effective treatment and preventive measures are
available.
Risk Group 3 (high individual risk, low community risk)
A pathogen that usually causes serious human 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.
Risk Group 4 (high individual and community risk)
Infectivity is indirectly proportional to biosafety measures. true or false
false it should be direct
Host range, Dissemination in the community, Infectivity, and Effectiveness of prophylactic measures are all indirectly proportional to biosafety measures. true or false
False, only the Effectiveness of prophylactic measures is indirect
The greater the severity, the higher the biosafety levels or
precautions to undertake.. true or false
true
RISK GROUPS are based on
Pathogenicity, MOT, effective preventative measures, and effective treatment
Pathogenicity and MOT are directly proportional to risk group while effective preventative measures and effective treatment are indirectly proportional to risk
group. true or false
true
PSDS acronym
Pathogen Safety Data Sheet
20% of laboratory acquired infections are due to equipment failure and 80% caused by human factors. true or false
true
ROUTES OF EXPOSURE
Ingestion, Inoculation, Contamination, and Inhalation
E. coli is under what BSL and risk group
BSL1 under risk group 2
salmonella is under what BSL and risk group
BSL2 under risk group 2
Pillars of Biosecurity
It is the assurance of safety from physical intrusion
→ Physical Security
→ Personnel management
→ Material control
→ Transport security
→ Information security
→ Emergency or incident response plan
→ Emerging biotechnology
→ Dual use research of concern
Physical Security
Principles of physical security
→ Detection (CCTV)
→ Delay (Locked doors)
→ Response
→ Access control
Pillars of Biosecurity
Assurance that there is an awareness of what exists in the laboratory, where it is, and who is responsible for it
→ Physical Security
→ Personnel management
→ Material control
→ Transport security
→ Information security
→ Emergency or incident response plan
→ Emerging biotechnology
→ Dual use research of concern
Personnel management
Assurance that the same rigorous processes that protect biological materials in the laboratory follow those materials when they are transported outside
laboratory areas
→ Physical Security
→ Personnel management
→ Material control
→ Transport security
→ Information security
→ Emergency or incident response plan
→ Emerging biotechnology
→ Dual use research of concern
Transport security
Assurance that the sensitive and valuable information stored in a
laboratory is protected from theft or diversion
→ Physical Security
→ Personnel management
→ Material control
→ Transport security
→ Information security
→ Emergency or incident response plan
→ Emerging biotechnology
→ Dual use research of concern
Information security
Refers to the documentation of the sequence of custody, control,
transfer, analysis, and disposition of sample from sender to recipient
Chain of Custody
Monitoring and assessing the scientific, ethical, and social implications
of certain biotechnologies as warranted, monitoring the development and
integration of those technologies into scientific and clinical practices,
→ Physical Security
→ Personnel management
→ Material control
→ Transport security
→ Information security
→ Emergency or incident response plan
→ Emerging biotechnology
→ Dual use research of concern
Emerging biotechnology
What must be done if the sample has been stolen?
→ Reporting
→ Action
→ Interrogate
Process of identifying the hazards/threats and evaluating the risks
associated with biological agents and toxins, taking into account the
adequacy if any existing controls, and deciding whether or not the risks are acceptable
assessment
The actual process of determining the likelihood (probability) and
consequence (severity) of a particular risk within a Risk Assessment
Risk Characterization
A crucial intermediary step between Risk Characterization and taking
active steps toward mitigating risk
* It is the process of determining, subjectively, whether a risk is high or low,
and whether it is acceptable or not
Risk Evaluation
Measures of control that will help you to lessen the risk that has been
assessed
mitigation
The most effective way to mitigate risks rely on the combination of the
measures and observance of proper utilization.
Personal Protective Equipment
there is no systematic way for evaluating risk and
determining risk acceptability. This will depend on the perceptions of
individuals, institutions, and the community. true or false
true
Hierarchy of Biorisk
bottom to top
Inadequate biorisk management - Near miis - harmful incidents
The laboratory worker acquires infection due to direct contact with a
pathogen
Primary infection
A laboratory worker infects other people with a pathogen from the
laboratory either through direct/indirect contact
Secondary infection
