BioRAFT Biological Safety Inspection Findings and Corrective Actions
Below are possible findings, corrective actions, and regulations that you might see in a biosafety inspection report. Please note that this is a general list
and findings/corrective actions might be edited or added to your personal report in order to reflect the actual and specific observations of the auditor.
While the Findings/Observations box at the top of the inspection report provides bullet points of the primary inspection findings for your lab, it is in no
way a holistic depiction of the circumstances of the report. Please be sure to read through the body of the summary for inspection details and
corrective actions specific to your lab.
*GMP=Good Microbiological Practices
**BBP inspections will not include all of these findings
Finding Category
Accidents &
Emergencies
Finding
Exposure Control Plan (ECP) is
not accessible to workers.
Accidents &
Emergencies
Accidents and exposures
(sharps injuries, etc.) have not
been reported or documented.
Accidents &
Emergencies
Spill and/or emergency
response procedures are not
developed or posted
Aerosols/splashes not
minimized or properly
contained.
Containment
Containment
Containment
Containment
Containment
Biohazards are not kept in
covered, leak-proof containers
during collection, processing,
storage, & transportation.
Biological safety cabinet
certification past due
Biosafety cabinet located near
door, air supply grill, or high
traffic area.
Biosafety cabinet misuse
Corrective Action
Corrective Action(s): Ensure that employees know the location of the ECP and can
access the ECP at all times (in print or as a digital copy:
http://www.cmu.edu/ehs/biological/documents.html).
Corrective Action(s): ALL spills and accidents, especially those resulting in personal
contamination or injury, MUST be immediately reported to EHS (412-268-8182).
Follow CMU procedures for accident/injury reporting and for seeking medical
attention. http://www.cmu.edu/hr/benefits/benefit_programs/forms/WCforms.pdf
Corrective Action(s): Develop and post spill & emergency response procedures
specific to your lab.
Regulation
OSHA’s BBP Standard
Corrective Action(s): Perform all procedures to minimize formation of splashes or
aerosol to prevent inhalation or contamination hazard. Procedures capable of
producing infectious aerosols must be conducted in a certified Biosafety Cabinet or
using other engineering/work practice controls to reduce possibility of exposure.
Corrective Action(s): Place cultures, tissues, specimens, or infectious wastes in
covered, leak-proof containers in order to reduce risk of exposure.
CDC/NIH BMBL 5th edition
Corrective Action(s): Biological Safety Cabinets must be certified annually. Please
contact Filtech (412-461-1400) and reference CMU EHS PO number to ensure that
your cabinet is certified promptly. The BSC should not be used until certification is
complete. Contact EHS with any questions.
Corrective Action(s): Locate BSC's away from drafts or air currents to prevent
movement of infectious aerosol outside of the cabinet.
CDC/NIH BMBL 5th edition
Corrective Action(s): BSC is used for all procedures with the capability of producing
infectious aerosols. Procedures using high concentrations or large volumes of
infectious agents, necropsies, harvesting, tissues/fluids from infected animals/eggs,
etc., produce a greater risk of exposure and also must be conducted in a BSC.
Reference "Proper Work Practices When Working in a Biosafety Cabinet (BSC)"
handout for the standard operating procedure.
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Containment
Doors are open/unlocked
while work is being conducted
or no one is present to control
access.
Corrective Action(s): To prevent exposure to persons outside of the lab, doors must
remain closed and locked when work with infectious agents is being conducted or
when no one is present in the space to monitor access.
CDC/NIH BMBL 5th edition
Containment
Improper vacuum trap set up.
CDC/NIH BMBL 5th edition
Containment
Windows open to the outside
and are not fitted with fly
screens.
Biohazard labels are not placed
on storage or processing
equipment.
Corrective Action(s): The first aspiration flask in the system should act as a
disinfectant trap, and contain a disinfectant appropriate for the agents in use. The
second flask acts as an overflow flask and should be set up to minimize aerosol
generation. HEPA filters must be placed between the overflow flask and the vacuum
line to prevent contamination of the vacuum system with aerosolized infectious
agents.
Corrective Action(s): 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
Corrective Action(s): Please label equipment such as refrigerators, incubators,
freezers, centrifuges etc. which are used to store biological materials or may be
contaminated with biohazard materials. Biohazard stickers must show the biohazard
symbol and be either red or orange.
Corrective Action(s): When infectious agents are present, signage must be posted
outside of the laboratory entrance and inform persons of agents in use, Biosafety
Level, required PPE, training requirements, and primary/secondary contact
information. This sign should be orange/red and prominently display the biohazard
symbol. Request a biohazard warning sign or make changes to your current sign by
contacting EHS. Do not remove, alter, or replace signs without EHS approval.
Corrective Action(s): Broken glassware must not be handled directly, as this increases
the risk of a sharps injury and possible exposure. Broken glassware should be
disposed of using a brush and dustpan, tongs, or forceps. Obtain these tools if they
are not present.
Develop and post decontamination procedures specific to your lab, including
disinfectant type used, agents being deconned, frequency of decontamination, and
step-by-step process
Corrective Action(s): Make disinfectants available and appropriate for the agents
being used.
Corrective Action(s): Ensure all disinfectant bottles are labeled with their contents.
CDC/NIH BMBL 5th edition
Corrective Action(s): Such activities should be strictly prohibited, as they provide an
unnecessary risk of exposure to the individual in the laboratory through ingestion or
contact with the eyes or mucous membranes. All food, drink, and personal items
should be stored in a designated space outside of the area with a risk for
contamination.
CDC/NIH BMBL 5th edition
GMPs
GMPs
Biohazard warning signs for
use areas are not posted or are
inaccurate.
GMPs
Broken glassware is not
handled by mechanical means.
GMPs
Decontamination procedures
are not developed/posted
GMPs
Disinfectants are not present,
or are inappropriate for agents
being used.
Disinfectants are not labeled
or the labels are illegible.
Eating, drinking, smoking,
handling contact lenses,
applying cosmetics, handling
personal items, or storing food
in lab.
GMPs
GMPs
CDC/NIH BMBL 5th edition
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CDC/NIH BMBL 5th edition
CDC/NIH BMBL 5th edition
CDC/NIH BMBL 5th ed.,
OSHA’s BBP Standard
CDC/NIH BMBL 5th edition
GMPs
Eyewash is not available,
blocked, or not functioning.
GMPs
Lab equipment and work
surfaces are not properly
decontaminated.
GMPs
Mouth pipetting observed.
GMPs
Sinks and/or soap not
available for handwashing.
GMPs
Lab contains elements that
cannot easily be cleaned
and/or decontaminated.
GMPs
Lab personnel were not
offered appropriate
immunizations or tests against
agents in use.
GMPs
Minimum training
requirements are not
established, enforced, and/or
site-specific training records
are missing/incomplete.
SOPs are not
developed/posted for work
conducted.
GMPs
Miscellaneous
Biological materials inventory
is missing, incomplete, or
inaccurate.
Miscellaneous
Animals or plants not involved
in work are present in lab.
Corrective Action(s): Keep eyewash accessible at all times. Do not block. Check weekly
for functionality. If the eyewash is found to be nonfunctioning, place a work order
with FMS to fix it.
Corrective Action(s): Laboratory equipment must be decontaminated with an
effective disinfectant on a routine basis, after working with infectious materials, and
especially after overt spills, splashes, or other contamination by infectious materials.
Decontaminate work surfaces after completion of work and after any spill or splash of
potentially infectious material with appropriate disinfectant. Additionally, any
equipment must be decontaminated prior to maintenance or removal from the lab.
Corrective Action(s): Mouth pipetting is prohibited; mechanical pipetting devices
must be used.
Corrective Action(s): A sink and soap must be available for handwashing. Persons
must wash their hands after working with potentially hazardous materials and before
leaving the laboratory.
Corrective Action(s): Spaces between benches, cabinets, and equipment should be
accessible for cleaning. Bench tops must be impervious to water and resistant to heat,
organic solvents, acids, alkalis, and other chemicals. Chairs used in laboratory work
must be covered with a non-porous material. All surfaces must be able to withstand
routine cleaning and disinfection, those that cannot, must be covered or replaced
with alternatives.
Corrective Action(s): Persons falling under OSHA's Bloodborne Pathogens Standard
are to be offered the HBV vaccine, free of charge, before beginning work with human
blood or OPIM. Work with other biological materials or certain animals may also
require specific immunizations and/or testing. All prophylaxis and testing options
available to laboratory personnel need to be documented.
Corrective Action(s): Follow EHS protocol for training requirements. Post necessary
training outside of the room to inform personnel of requirements. Enforce
institutional and laboratory training policies and document all site specific training
(http://www.cmu.edu/ehs/biological/documents.html). Restrict access to the room
to only trained, competent personnel.
Corrective Action(s): Standard operating procedures need to be made available in
writing for the standard protocols performed in all BSL-2 spaces (e.g. tissue culture,
decontamination, biosafety cabinet usage, etc.). This reduces the possibility of
accidents caused by uncertainty. Develop, document, and post SOP's for common
laboratory procedures or create a site-specific biosafety manual.
Corrective action: All researchers who use or possess biological materials must submit
an accurate and up-to-date biological materials inventory to EHS
(http://www.cmu.edu/ehs/biological/inventory-registration.html). This should be
done when your work begins and then when any significant changes are made to the
materials being used. Please submit your up-to-date inventory to
angelar@andrew.cmu.edu.
Corrective Action(s): Animal and plants not associated with the work being performed
must NOT be permitted in the laboratory, and should be removed if they are present.
CDC/NIH BMBL 5th edition
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CDC/NIH BMBL 5th edition, 29
CFR 1910.1030, OSHA BBP
Standard, CDC Universal
precaution
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Miscellaneous
Lighting is dim or inadequate.
Miscellaneous
Plastic ware is not used in
place of glassware.
Appropriate PPE is not worn in
the lab
PPE
PPE
Contaminated PPE is not
removed/handled properly.
PPE
PPE is not removed and/or
hands are not washed before
entering "clean" areas.
Respiratory protection is
inappropriately worn.
PPE
Select agents
Protocol deviation.
Training
Biosafety training overdue.
Training
Bloodborne pathogen initial
training required.
Training
Bloodborne pathogens annual
refresher training past due.
Waste
Contaminated biowaste
(sharps/nonsharps) is disposed
of improperly.
Corrective Action(s): Ensure adequate lighting for each laboratory space. Submit a
request through FMS in order to have a light changed (FMS will only enter the space if
the mopman is present, so ensure that it is safe for them to enter).
Corrective Action(s): Plastic materials should be substituted for glassware whenever
possible to reduce the risk of glass breaking and possible exposure of personnel.
Corrective Action(s): PPE is required at all times when performing work in BSL2. PPE
must be donned upon entry and removed before exiting. This includes disposable
gloves, safety glasses and a lab coat (specific requirements are posted outside of the
lab on the biohazard signage). Not wearing PPE poses an unnecessary exposure risk.
Personnel performing procedures posing a splash risk outside of a BSC must wear
goggles and/or a face shield.
Corrective Action(s): Change PPE when contaminated and dispose of or
decontaminate according to institutional policies. Do not reuse gloves. Reusable PPE,
such as lab coats, can be laundered by the institution and are not to be taken home
for laundering purposes.
Corrective Action(s): Remove ALL PPE and wash hands before leaving biohazard-use
areas. Remove gloves and wash hands prior to touching 'clean' surfaces in the lab
(e.g. telephones, keyboards, etc.).
Corrective Action(s): Persons working with infected animals, who could be exposed to
infectious aerosols via inhalation, should consult EHS about respiratory protection.
Anyone who must wear a respirator in the course of their job at Carnegie Mellon, falls
under the purview of OSHA and the CMU Respiratory Protection Program. Persons in
this program require annual refresher training and annual fit tests.
Corrective Action(s): If planned work will require the use of a select agent regulated
under the Patriot Act, you must contact EHS BEFORE purchasing or requesting the
material. The Patriot Act may require registration, increased security and tracking of
select agents. EHS must inform the CDC of select agent use in the CMU community.
The Select Agent Policy outlines the key definitions and procedures for this work.
Follow CMU protocols for obtaining, handling, storing, and disposing of Select Agents.
Corrective Action(s): All laboratory personnel working in a BSL2 laboratory must
attend Biological Safety Training (https://cmu.bioraft.com/node/284551/sessions).
Training is mandatory.
Corrective Action(s): Bloodborne pathogen (BBP) training required when working with
human blood, human cell lines, tissues, organs, and other bodily fluids. Refresher
training is required annually. Complete BBP training before research commences
(https://cmu.bioraft.com/node/284552/sessions).
Corrective Action(s): Bloodborne pathogen (BBP) training requires annual
recertification. Complete BBP Refresher training before continuing research
(https://cmu.bioraft.com/node/284552/sessions).
Corrective Action(s): Biowaste, sharps (including needles, syringes, glass, razor blades,
etc.), and broken glass must never be placed in the regular trash. All biowaste and
sharps/glass should be disposed of via appropriate containers
(http://www.cmu.edu/ehs/biological/waste.html).
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The Patriot Act, Federal
Select Agent Program
(CDC/APHIS)
CDC/NIH BMBL 5th edition
29 CFR 1910.1030, OSHA BBP
Standard
29 CFR 1910.1030, OSHA BBP
Standard
CDC/NIH BMBL 5th edition
Waste
Sharps are manipulated prior
to disposal.
Waste
Sharps container too full.
Waste
Sharps containers are not
present, labeled, conveniently
located, puncture resistant,
and/or leak proof.
Corrective Action(s): Manipulation of sharps presents a risk of puncture injury and
greater chance of exposure to the biohazards being worked with. Deposit needles and
other sharps directly into the sharps container after use. Do not recap or manipulate
sharps before disposing of them. (http://www.cmu.edu/ehs/biological/waste.html)
Corrective Action(s): Do not fill containers beyond the fill line. Where no fill line is
present, do not fill the container more than 3/4 full. Tape shut or seal according to
directions. Replace the container when necessary to prevent over-filling.
(http://www.cmu.edu/ehs/biological/waste.html)
CDC/NIH BMBL 5th edition
Corrective Action(s): All sharps containers must have the biohazard label on the
outside. Each container should be within reach of the work being performed. All
containers must be hard-walled and leak-proof to prevent exposure of individuals.
Make sure sharps containers fit specifications. Request new containers from EHS.
(http://www.cmu.edu/ehs/biological/waste.html)
CDC/NIH BMBL 5th edition
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