FUNDAMENTALS AND CONCEPTS OF Newell A.

Johnson
LABORATORY BIOSAFETY AND - modifications for BioSafety at Camp Derrick
BIOSECURITY -developed BSL II safety cabinets and laminar
flow hoods
Biosafety
- containment principles, technologies, and 1944 [Pioneers of Biosafety]
practices that are implemented to prevent - Arnold Wedum
unintentional exposure to pathogens and toxins or -Director of Industrial Health and Safety at the US
their accidental release” Army Biological Research Laboratories
- protects people from microorganisms -provided foundations
-focuses on laboratory procedures and practices
needed to prevent exposure to and acquisition of 1966 [Wedum and Morton Reitman]
infection - analyzed multiple epidemiological studies of
laboratory-based outbreaks
Biosecurity
- protection and control and accountability for 1967 [Smallpox Eradication (WHO)]
valuable biological materials within laboratories, - aggressively pursued to eradicate due to high
in order to prevent their unauthorized access, loss, mortality rates.
theft, misuse, diversion, or unintentional release”
- protects microorganisms from people 1967 [World Health Assembly]
- maintenance of secure procedures and practices -remaining stocks of virus in 2 locations
in handling biological materials and sensitive - Center for Disease Control (CDC); USA
Information. - State Research Center of Virology and
Biotechnology (SRCVB VECTOR); Russia
Biosafety Levels
- technical means of mitigating risk of accidental GUIDELINES THAT LAID THE
infection from or release of agents in the FOUNDATION FOR THE INTRODUCTION
environment. OF A CODE IN BIOSAFETY PRACTICE
- emphasis on equipment and facility controls
1974 - CDC
Biosafety officer “Classification of Etiological Agents on the Basis
-administrative role of ensuring of lab personnel of Hazard”
-introduced concept of establishing ASCENDING
BRIEF HISTORY OF BIOSAFETY levels of containment associated with risks in
1907-1908 [Arnold Wedum] handling groups of infectious microorganisms
- mechanical pipettors to prevent LAI with similar characteristics

1909 [Ventilated Cabinet] 1976 - National Institutes of Health (NIH) of

- prevent infection from mycobacterium US
tuberculosis (MTB) “NIH Guidelines for Research Involving
Recombinant DNS Molecules’
1943 [Ira L. Baldwin] - explained the microbiological practices,
- first scientific director of Camp Detrick equipment, and facility necessarily corresponding
-tasked with establishing the Biological Weapons to FOUR ASCENDING LEVELS of PHYSICAL
Program for defensive purpose CONTAINMENTS

1943 [US Biological Weapons Program] 1983 -Laboratory Biosafety Manual - WHO
- Started; Franklin Roosevelt 3rd Ed.
- origin of biosafety is rooted. - info about diff levels of containment labs
- Terminated; 1969, Richard Nixon (BSL1-4)\
- dif. types of safety cabinets, how to March 17, 2006 - EO. 514
disinfect/sterilize - National Biosafety Framework (NBF)
- Biosecurity; packaging required for by - policy, legal, administrative, and technical
international transport regulations and other types instruments developed to attain the objective of
of safety procedures the Cartagena Protocol on Biosafety

1984 - CDC and NIH (collab) DIFFERENT ORGANIZATIONS IN

“Biosafety in Microbiological and Biomedical BIOSAFETY AND BIOSECURITY
Laboratories”
- marked the development of the practice of 1. American Biological Safety Association
biosafety (ABSA)
- established model of biosafety containment - 1984; a regional professional society
levels - promotes biosafety AS A SCIENTIFIC
- increased BSL on agents that pose risk in human DISCIPLINE
health
2. Asia Pacific Biosafety Association (A-PBA)
BRIEF HISTORY OF BIOSECURITY - 2005; acts as a professional society for biosafety
1996 - Select Agent Regulations professionals in Asia-Pacific region
- monitor the transfer of a select list of biological - SG. PH, MY, BR, IN, CH, TH, MYNM
agents from one facility to another
3. European Biological Safety Association
2001 - Anthrax Attacks or AMERITHRAX (EBSA)
- revised Select Agent Regulations; required - June 1996; a non-profit org.
specific measures for any facility in the US that - aims to provide a forum for discussions and
stored one or more agents in the newer longer list debates on issues of concern and to represent
of agents. those working in the field of biosafety.
- encouraging, communicating, legislation and
2005 - Singapore Standards
“Biological Agents and Tosins Act”
- harsher penalty, similar scope 4. Philippine Biosafety and Biosafety and
Biosecurity Association (PhBBA)
2005 - South Korea - multi disciplinary team
“Act on Prevention of Infectious Diseases” - from National Laboratory Biosafety and
- require institutions to implement laboratory Biosecurity Action Plan Task Force; DPO No.
safety 2006-2500
- “highly dangerous pathogens - September 15, 2006
- assist the DA and DOH to create a national
Japan - “Infectious Disease Control Law” policy and implementation
-four schedules of select agents
5. Biological Risk Association Philippines
2008 - Danish Parliament (BRAP)
- regulate the possession, manufacture, use, and - non-government and non-profit association
storage etc. of listed biological agents - “assess, mitigate, monitor”
- works to serve the emergent concerns of
2003 - Cartagena Protocol on Biosafety (CPB) biological risk management in various
- 168 member - countries professional fields.
- international framework to ensure “an adequate
level of protection in the field of safe transfer,
handling, and use of LMOs (Living Modified
Organisms)
- PH signed May 24, 2000
BIOSAFETY: PATIENT SAFETY SAFETY STANDARDS AND GOVERNING
-98% of the errors in the diagnostic process occur AGENCIES
in the pre-analytic phase Safety standards for patients and clinical
- likely reason for pre-analytic variability is lack laboratories are initiated, governed, and reviewed
of professional training related to blood collection. by the following federal agencies and professional
-Improve the accuracy of patient identification organizations 6–10:
Use at least two patient identifiers when providing 1. OSHA, U.S. Department of Labor
laboratory services.
2. Clinical and Laboratory Standards Institute
(CLSI)

3. CDC, U.S. Department of Health and

Human Services, Public Health Service (PHS)

4.College of American Pathologists (CAP)

5. The Joint Commission. TJC has established

National Patient Safety Goals, some of which
apply specifically to laboratories

National Healthcare Safety Network (NHSN)

BIOSAFETY: LAB SAFETY -surveillance systems and provides data on
Safety in the clinical laboratory encompasses devices, patients, and staff
bloodborne pathogen protection and chemical, -Under this is the National Nosocomial Infections
fire, and electrical safety Surveillance System of the CDC
Ergonomics - It presented that highest rates of infection
● - “work-related musculoskeletal disorder occurred in the burn ICU, the neonatal
hazard ICU, and the pediatric ICU
● -ergonomic stressors, such as back strain - Risk factors for the invasion of colonizing
from an uncomfortable chair or aching feet pathogens can be categorized into the
from walking or standing on hard floors. following three areas:
Repetitive actions such as pipetting or a. Iatrogenic
typing are potential sources of motion b. Organizational risk
injuries (such as carpal tunnel syndrome c. Patient risk factors
***Nosocomial infections are caused by viral,
bacterial, and fungal pathogens. This infection is a
OSHA and CDC
hospital-acquired infection.
have published numerous safety standards and
regulations that are applicable to clinical
OSHA-Mandated Plan
laboratories. Ensuring safety in the clinical
A. Chemical Hygiene Plan
laboratory includes the following measures:
-the core of the OSHA safety standard
● A formal safety program
Examples of the CHP requirements
● specifically mandated plans (such as
• A list of chemicals in inventory
chemical hygiene and bloodborne
• Availability of SDSs
pathogens)
• Labeling requirements
● Identification of various hazards (such as
• Record-keeping requirements
fire, electrical, chemical, and biological)
• Standard operating procedures and housekeeping
● Safety officer
requirements
•Exposure Control Plan
B. Hazard Communication Standard Laboratory Acquired Infection
1. Hazard classification: Chemical CLASSIFICATION OF MICROORGANISMS
manufacturers and importers are required to TO RISK GROUP
determine the hazards of the chemicals they - WHO, Four total.
produce or import. - based on agent’s pathogenicity, mode of
2. Labels: Chemical manufacturers and importers transmission, host range, and availability of
must provide a label that includes a signal word, preventative measures and effective treatment.
pictogram, hazard statement, and precautionary
statement for each hazard class and category. 1. Risk group 1
3. Safety data sheets: The new SDS format - unlikely to cause human or animal disease
requires 16 specific sections, ensuring consistency - Low individual an and community risk
in presentation of important protection 2. Risk group 2
information - unlikely to be a significant risk to lab workers
4. Information and training: To facilitate and the community and livestock.
understanding of the new system, the new - Exposure may cause infection, treatment
standard requires that workers be trained available
- Moderate individual risk and limited community
C. Exposure Control Plan risk
● safety precautions concerning the handling 3. Risk group 3
of all patient specimens, known as - known to cause serious diseases to humans and
Standard Precautions, previously called animals, significant risk to lab workers
Universal Precautions. - Limited to moderate community risk
Biohazards - effective preventive measures and treatment are
● denote infectious materials or agents that available
present a risk or even a potential risk to the 4. Risk group 4
health of humans or animals in the -life threatening diseases to humans and animals
laboratory - significant risk to lab workers
-readily transmissible from one individual to
1968 - Charles Baldwin another
● created the biohazard symbols. -effective treatment not usually available
- High individual and community risk

SAFE WORK PRACTICES FOR

INFECTION CONTROL

Laboratory-Acquired Infections (LAI) A. Personal Protective Equipment

● is defined as an infection acquired through ● specialized clothing or equipment worn by
laboratory or laboratory-related activities an employee for protection against a
regardless of whether they are hazard
symptomatic or asymptomatic 1. Glove
The most common routes of exposure and vinyl or latex
accidental inoculation are as follows: 2. Facial Barrier Protection
• Inhalation (such as aerosols) potential for splashing or spraying of
• Percutaneous inoculation (such as needle and blood or certain body fluids.
syringe, cuts or abrasions from contaminated 3. Laboratory Coats or Gowns as Barrier
items, and animal bites) Protection
• Contact between mucous membranes and used whenever laboratory personnel are
contaminated material (such as hands and working with potentially infectious
surfaces) specimens
• Ingestion (such as aspiration through a pipette,
smoking, and eating
4. Nail Care ● Air containing the infectious agent is
promote infection control, nails should be sterilized by passage through a high-
no longer than ¼ inch beyond the tip of the efficiency particulate air filter
finger. Longer nails do not fit into gloves
properly and can cause problems with
blood collection and analysis
5. Shoes
shoes worn in the clinical laboratory and
phlebotomy services should be rubber-
soled and cover the entire foot
6. Electronic Devices
Electronic devices (such as smart phones
and tablet computers) should not be Categories of Laboratory Biosafety according
exposed to potential sources of infectious to Levels
contamination 1. Biosafety Level 1 (BSL-1)
- well-characterized strains known not to cause
B. Handwashing disease in humans
● performed after contact with patients and - Bacillus subtilis, Naegleria gruberi, infectious
laboratory specimens. Gloves should be canine hepatitis virus
used as an adjunct to, not a substitute for, - undergraduate and secondary educational
handwashing training and teaching laboratories
● hands should be washed with soap and - basic level of containment.
water or by hand antisepsis with an
alcohol-based hand rub even if hands are 2. Biosafety Level 2 (BSL-2)
not visibly soiled - indigenous moderate-risk agents
- clinical, diagnostic, and teaching laboratories
C. Decontamination of Work Surfaces, - Hepatitis B virus, HIV, salmonellae, and
Equipment, and Spill Toxoplasma species
● Disinfection- - human blood, body fluids, tissues, or primary
○ describes a process that eliminates human cell lines
many or all pathogenic - Hand washing sinks and waste decontamination
microorganisms, except bacterial facilities
spores, on inanimate objects - conducted in biosafety cabinets or other physical
● Disinfecting Solutions containment equipment
○ Hypochlorites, the most widely
used of the chlorine disinfectants, 3. Biosafety Level 3 (BSL-3)
are available in liquid (such as - emphasis on primary and secondary barriers
sodium hypochlorite) or solid (such - indigenous or exotic agents with a potential for
as calcium hypochlorite) forms respiratory transmission; potentially lethal
infection
D. Protection from Aerosols - Mycobacterium tuberculosis, St. Louis
Biosafety Cabinets encephalitis virus, and Coxiella
○ Biosafety cabinets are protective - performed in a biosafety cabinet or gastight
workplace devices used to control aerosol generation chamber
the presence of infectious agents in - controlled access to the laboratory and vent
the air requirements
○ processing of specimens for - Personnel must be supervised by scientists
culture—grinding, mincing,
vortexing, centrifuging, and
preparation of direct smears—are
known to produce aerosol droplets.
4. Biosafety Level 4 (BSL-4)
- dangerous and exotic agent that pose high
individual risks
- no available vaccines or treatment
- transmit via the aerosol route
- Marburg or the Crimean-Congo hemorrhagic
fever
- laboratory worker's complete isolation
- working in a Class III biosafety cabinet or in a
full body, air-supplied positive-pressure personnel
suit
- separate building or completely isolated zone

ADDITIONAL LABORATORY HAZARDS

Chemical Hazards

Electrical Hazards

Fire Hazards

Physical Hazards