©2018 Ministry of National Guard - Health Affairs

Gulf Cooperation Council – Centre for Infection Control

Riyadh, Kingdom of Saudi Arabia

L.D no. 1430/64

ISBN: 978-603-90062-1-3

The Ministry of National Guard Health Affairs – Infection Prevention and

Control Department, as host secretariat and directorate for the Gulf
Cooperation Council – Center for Infection Control (GCC-CIC) has the
sole copyright to this publication.

Any part or parcel of this manual may not be copied, deleted,

reproduced, or cited without prior approval and/or acknowledgment of
source from the Director of the GCC-CIC.

Comments, reviews, and feedback on this manual may be directed and

brought to the attention of the Director of the GCC-CIC.

Mail Code 2134, P.O Box 22490

Riyadh 11426, Kingdom of Saudi Arabia
Phone: 966-1-8043893
Fax:+ 966-1-2520437/ + 966-1-8043733
Email: [email protected]
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EFFECTIVE DATE: APPLIES TO: ISSUING AUTHORITY:

01/01/2018 All GCC Countries GULF COOPERATION COUNCIL – CENTRE

FOR INFECTION CONTROL (GCC-CIC)

DEFINITION

To establish guidelines that would assist in minimizing or preventing the transmission of infectious agents in
the laboratory.

REFERENCE

Association for Professionals in Infection Control (APIC) and Epidemiology, Inc. (2014) Chapter 108:
Laboratory Services. In APIC Text of infection control and epidemiology (4th ed.).

COMMENTS

1. The laboratory is a unique work environment that may pose infectious disease threats to those who
work there.
2. Biosafety levels were established to ensure that the laboratory environment is adequately equipped
with measures to ensure safety of those working in them or the surrounding environment.
3. Special procedures are used to ensure the safe handling and transport of biohazardous waste.
4. Being one of the largest generators of infectious waste in the healthcare setting, specific procedures
exist for laboratory infectious waste management.
5. Laboratorians should be an integral part of an infection prevention program. The microbiology
laboratory helps detect and identify microorganisms so that the infection control team can monitor,
prevent, and control infection transmission.

PROCEDURE

A. Biological Risk Assessment

Each clinical laboratory should perform a biological risk assessment on an annual basis or any time a
new risk is identified. It is a process used to identify the hazardous characteristics of known infectious
or potentially infectious agent or materials; the activities that can result in a person’s exposure to an
agent; and, the likelihood that such exposure will cause laboratory acquired infections (LAIs).

The primary factors in the risk assessment and selection of precautions fall into two broad categories:
agent hazards and laboratory procedure hazards. Although there is no standard approach for
conducting s biological risk assessment, the Biosafety in Microbiological and Biomedical Laboratories
(BMBL) documents suggest a five-step approach to prevent LAIs.
1. Identify agent hazards and perform an initial assessment of risk:
a. Review potential biological agents and their hazardous characteristics. Hazardous characteristics
include their capability to infect and cause disease in a susceptible human host, severity of
disease, the availability of preventive measures.
b. Implement regulations that govern the possession, use, and transfer of these types of biological
agents and toxins that have the potential to pose a severe threat to public health and safety.
2. Identify laboratory procedure hazards
Procedure hazards often found in a clinical lab include agent concentration, suspension volume,
equipment and procedures that generate small-participle aerosols and larger airborne particles
(droplets), complexity of lab procedures, and use of sharps.

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3. Make a final determination of the appropriate biosafety level and select additional precautions
indicated by the risk assessment.
4. Evaluate the proficiencies of staff regarding safe practices and the integrity of safety equipment.
a. Evaluate the laboratorian’s training and experience in handling infectious agents.
b. Proficiency in the use of sterile techniques and Biological Safety Cabinet (BSC).
c. Ability to respond to emergencies and willingness to accept responsibility for protecting one’s
self and others.
5. Review the risk assessment with a biosafety professional subject matter expert and the institutional
biosafety committee.

Once the risk assessment is completed it should be reviewed by site-specific, and if necessary, local
experts in biosafety. This review should include the Infection Preventionist (IP), laboratory safety, and
infection prevention and control committee, as well as, Safety Committee.

B. Standard Microbiological Practices, Safety Equipment, and Facility Safeguards

1. Standard microbiological practices

a. The laboratory supervisor must enforce the institutional policies that control access to the laboratory.
b. Personnel must wash their hands after working with potentially hazardous materials and before
leaving the laboratory.
c. Do not permit eating, drinking, smoking handling contact lenses, applying cosmetics, and storing
food for human consumption in laboratory areas.
d. Prohibit mouth pipetting; use mechanical pipetting devices.
e. Develop and implement policies for the safe handling of sharps (e.g., needles, scalpels,
pipettes, broken glassware). Whenever practical, laboratory supervisors should adopt improved
engineering and work practice controls that reduce risk of sharp injuries. Follow precautions
below when dealing with sharps:
i. Do not bend, shear, break and recap needles nor remove from disposable syringes, or
otherwise manipulate by hand before disposal.
ii. Place used disposable needles in conveniently located puncture-resistant sharp containers.
iii. Do not handle broken glassware directly by hands; it must be removed using a brush and
dustpan, tongs or forceps. Substitute plastic ware for glassware whenever possible.
f. Perform all procedures to minimize the creation of splashes and/or aerosols.
g. Decontaminate work surfaces after completion of work and after any spill or splash of potentially
infectious material with appropriate disinfectant.
h. Decontaminate all cultures, stocks, and other potentially infectious materials before disposal
using an effective method. Depending on where the decontamination be performed, the
following methods should be used prior to transport:
i. Place in durable, leak proof container all materials to be decontaminated outside of the
immediate laboratory and secure for transport.
ii. Pack materials in accordance with local and state regulations.
i. Post the universal sign symbol at the entrance to the laboratory when infectious agents are
present. Posted information must include the laboratory biosafety level, the supervisor’s name
(or other responsible personnel), the telephone number, and required procedures for entering
and exiting the laboratory.
j. Develop an effective pest management program.
k. The laboratory supervisor must ensure that laboratory personnel receive appropriate training
regarding their duties, the necessary precautions to prevent exposures, and exposure evaluation
procedures.

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2. Special practices
a. Advise all persons entering the laboratory of the potential hazards and meet specific entry/exit
requirements.
b. Provide laboratory personnel with medical surveillance and offer appropriate immunizations for
agents handled or potentially present in the laboratory.
c. Store a baseline serum sample.
d. Prepare and adopt as a policy a laboratory-specific biosafety manual. The biosafety manual
must be available and accessible.
e. The laboratory supervisor must ensure that laboratory personnel demonstrate proficiency in
standard and special microbiological practices before working with Biosafety Level (BSL-2) agents.
f. Place potentially infectious materials in a durable leak-proof container during collection,
handling, processing, storage, or transport within a facility.
g. Decontaminate laboratory equipment routinely, as well as after spills, splashes, or other potential
contamination.
h. Evaluate and treat immediately any incidents that may result in exposure to infectious materials
according to procedures described in the laboratory biosafety manual. All such incidents must
be reported to the laboratory supervisor. Provide medical evaluation, surveillance, and
treatment and maintain appropriate records.
i. Do not permit animals and plants not associated with work being performed in the laboratory.
j. Conduct all procedures involving the manipulation of infectious material that may generate an
aerosol within a biosafety cabinet (BSC) or other physical containment devices.

C. Safety Equipment (primary barriers and PPE)

1. Use properly maintained BSCs (preferably Class II), other appropriate PPEs, or other physical
containment devices whenever:
a. Procedures with potential for creating infectious aerosols or splashes are conducted. These may
include pipetting, centrifuging, grinding, blending, shaking, mixing, sonicating, opening
containers of infectious materials, inoculating animals intra-nasally, and harvesting infected
tissues from animals or eggs.
b. High concentrations or large volumes of infectious agents are used. Such materials may be
centrifuged in the open laboratory using sealed or rotor heads or centrifuge safety cups.
2. Wear protective laboratory coats, gowns, smocks, or uniforms designated for laboratory use while
working with hazardous materials. Remove protective clothing before leaving for non-laboratory
areas (e.g., cafeteria, library, administrative offices).
3. Wear eye and face protection (goggles, mask, face shield, or other splatter guard) for anticipated
splashes or sprays of infectious or other hazardous materials when handling microorganisms outside
the BSC or containment device. Persons wearing contact lenses should also wear eye protection.
4. Wear gloves to protect hands from exposure to hazardous materials. Select gloves based on an
appropriate risk assessment. Alternative to latex gloves must be available. Do not wear gloves
outside the laboratory. In addition, BSL-2 laboratory workers should:
a. Change gloves when contaminated or when integrity has been compromised.
b. Remove gloves and wash hands when work with hazardous materials has been completed and
before leaving the laboratory.
c. Do not wash or reuse disposable gloves.
Use eye, face and respiratory protection in rooms containing infected animals as determined
by the risk assessment.

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D. Laboratory Facilities (secondary barriers)

1. Laboratory doors should be self-enclosing and have locks in accordance with institutional policies.
2. Laboratory must have sink for hand washing. The sink may be manually, hands free, or automatically
operated. It should be located near the exit door.
3. The laboratory should be designed so that it can be easily cleaned and decontaminated. Carpets
and rugs are not permitted.
4. Laboratory furniture must be capable of supporting anticipated loads and uses. Spaces between
benches, cabinets, and equipment should be accessible for cleaning.
a. Bench tops must be impervious to water and resistant to heat, organic solvents, acids, alkalis,
and other chemicals.
b. Hairs used in laboratory must be covered with a nonporous material that can be easily cleaned
and decontaminated with appropriate disinfectant.
5. Laboratory windows that open to the exterior are not recommended. However, if a laboratory does
have windows that open to the exterior, they must be fitted with screens.
6. BSC must be installed so that fluctuations of the room air supply and exhaust do not interfere with
proper operations. BSC should be located away from doors, windows that can be opened, heavily
traveled laboratory areas, and other possible airflow disruptions.
7. Vacuum lines should be protected with HEPA filters or their equivalent. Filters must be replaced as
needed. Liquid disinfectant traps may be required.
8. An eyewash station must be readily available.
9. Clinical laboratories must maintain proper handling according to the procedures they are
performing. Typically, a clinical lab has negative airflow to the adjacent areas. Specialized areas
such as rooms where polymerase chain reaction (PCR) may need positive air pressure to limit
potential RNA contamination of the reagents. Facilities should consider mechanical ventilation
systems that provide an inward flow of air without recirculation to space outside laboratory.
10. HEPA-filtered exhaust air from a Class II BSC can be safely recirculated back into the laboratory
environment if the cabinet is tested and certified at least annually and operated according to
manufacturer’s recommendations.
11. A method for decontaminating all laboratory wastes should be available in the facility (e.g.,
autoclave, chemical disinfection, incineration, or other validated decontamination method).

E. Laboratory Equipment
There are three general types of BSCs: Classes I, II, and III. All BSCs must be recertified annually by an
independent professional.
1. Class I BSC – this cabinet is similar to a chemical fume hood and has an inward airflow through the
front opening. Exhaust air from the BSC is passed through a HEPA Filter so that the equipment
protects both worker and the general public. However, the specimen and other materials are
potentially subject to contamination. Class I are not generally recommended for work that involves
biohazardous material.
2. Class II BSCs - designed to protect the worker, the general public, and the specimen. Airflow velocity
at the face of the work opening is at least 75 linear ft/min (lfpm). Both the supply air and exhaust air
are the HEPA-filtered. There are four types of Class II BSCs (IIA, IIB2, and IIB3). They differ in the
amount of recirculation, down flow, and inflow. Usually, all but IIA are considered satisfactory for
biohazardous and toxic agents.
3. Class III BSCs – are totally enclosed, ventilated cabinets of gas-tight construction that offer the
highest degree of protection from infectious aerosols. They also protect research materials from
biological contamination. Class III BSCs are most suitable to work with hazardous agents that require
containment at BL-3 or BL-4. All operations in the work area of the cabinet are performed through

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attached rubber gloves. The cabinets are operated under negative pressure. Supply air if HEPA iltered,
and the cabinet exhaust air is filtered by two HEPA filters in series or HEPA filtration followed by
incineration before discharge outside of the facility. The CLASS II BSC must be connected to double-
door autoclaves and chemical dunk tanks to permit sterilization or disinfection of all materials before
leaving the cabinet and also to allow supplies to enter the cabinet.
4. Centrifuges are commonly used in the clinical laboratory as part of specimen processing. Hazards
associated with centrifuging include mechanical failure (e.g. rotor failure, tube or bucket failure) and the
creation of aerosols. Use safety precautions to decrease the risk and associated with centrifugation.
Examples of these precautions include:
a. Use sealed tubes and safety buckets that seal with O-rings.
b. Filling open centrifuge tubes, rotors, and accessories in a BSC.
c. Always balance buckets, tubes, and rotors properly before centrifugation.
5. Phlebotomy in most hospital setting, the laboratory is responsible for most phlebotomy procedures.
Handle all body fluids using standard precautions.
a. Wear gloves when performing venipuncture.
b. Wear other protective equipment such as goggles, mask or lab coat for a procedure based on the
risk of exposure (i.e., arterial punctures).
c. Use safe needles at all times.
d. Use only single-use disposable tube holders.
e. Dispose all phlebotomy needles promptly in a puncture-resistant container to prevent their reuse or
accidental injury to a handler.

F. Transporting Biohazardous Waste Materials

Laboratories often need to transport biohazardous materials offsite. This transport may be across campus,
cross town to another laboratory. Personnel who package and ship these specimens must be concerned with
their safety and the protection and safety of those who receive the material.

1. Meet packaging standards for samples transported by local carriers such as cabs, hospital, and clinical
vehicles, or personal cars.
2. The requirements for shipping biohazard materials interstate or intrastate depend on the type and
volume of specimen. The regulations define three types of specimens:
a. Biological products – are finished biological substances for veterinary or human use such as vaccines
and reagents. These products must meet public health standards (9 CFR Parts 102-104 and 21 CFR
Parts 312 and 600-680).
b. Diagnostic (clinical substances) – comprises excreta, secretions, blood and its components, as well as
tissue and tissue fluids that are being shipped for diagnostic purposes.
c. Infectious (etiological) substances – include organisms known to be pathogenic to humans and
clinical samples with a high likelihood of being infectious. Infectious substance could include clinical
specimens such as enzyme immunoassay (EIA), HIV-positive serum submitted for Western blot
analysis, and sputum samples from patients known to be culture-positive for tuberculosis.
3. The essential element for protection is the triple-containment packaging, which is required for shipping
each of these substances. In all categories and volumes, there must be a primary container accompanied
by enough absorbent material to contain the whole sample, a waterproof container, and an outer
container. The packaging is expected to able to withstand rough handling and passage through
cancellation machines, sorters, and conveyors throughout the transport. The sample identification
document must be located outside the secondary containment. Additionally, labels clearly marking the
biohazard level must be prominently displayed on the outside container. Depending on the level of
biohazard, additional labels and information may need to be displayed, as well.

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G. Infectious Waste Management

Steam autoclave is the method of choice for decontaminating discarded cultures. If laboratory wastes
must be stored before disposal, storage should be as brief as possible. The site must be properly
identified with a biohazard label, have restricted access, and be located near the site of generation.
Clean the areas thoroughly each time it is emptied of waste contents. Refer to ICM-IX-02
Management of Infectious Waste.

H. Infection Prevention and Occupational Exposures

The goal of occupational health in a clinical lab and in university research laboratories is to promote a
safe and healthy workplace. Educate laboratory workers about the biohazards to which they may be
occupationally exposed.

1. Provide workers who may be exposed to highly pathogenic agents such as in a clinical research lab
a pre-placement medical evaluation. The workers’ supervisors should provide his staff a description
of the requirements for the position and an understanding of the potential hazard present in the
work environment.
2. The healthcare provider should review the worker’s previous and ongoing medical problems,
current medications, allergies to medicines, animals, and other environmental proteins, and prior
to immunizations.
3. Provide vaccines to workers to protect them against infectious agents to which they may be
occupationally exposed.
4. Encourage workers to seek medical evaluation for symptoms that they suspect may be related
to infectious agents in their work area without fear of reprisal. A high index of suspicion for
potential occupational exposures should be maintained during any unexplained illness among
workers or visitors to worksites containing biohazards.
5. Report all occupational injuries to Employee Clinic or Occupational Health Department.

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