Division of Laboratory Services

• Decontamination-The removal or inactivation of biological agents by physical or chemical means.
• Disinfection-A procedure, usually chemical, that inactivates viruses or kills vegetative bacteria, but not necessarily resistant forms such as spores.
• Sanitize-An agent that reduces the numbers of vegetative bacteria.
• Sterilize-The complete elimination or destruction of all forms of life by a chemical or physical means.

Disinfection suffixes

-cide- Kills (determined by specific testing)

Examples:

• Bactericide - (= germicide)-Destroys vegetative bacteria only.
• Tuberculocide - Destroys Mycobacterium tuberculosis.
• Sporocide - Destroys spores.

-static- Prohibits growth but may not kill.

Examples:

• Bacteriostatic - prevents growth of vegetative bacteria
• Tuberculostatic - prohibits growth of Mycobacterium tuberculosis

​In the U.S. manufacturers must register disinfectants. The United States Environmental Protection Agency (EPA) maintains 12 lists of chemical disinfectants. 

Desirable disinfectant characteristics (no one disinfectant possesses all these):

• Broad spectrum
• High efficiency
• Not affected by organic matter
• Non-toxic, non-corrosive, non-flammable
• Odorless
• Inexpensive
• Environmentally friendly

In order to effectively eliminate pathogens it is important to:

• Select the appropriate disinfectant for the agent to be killed or inactivated
• Use the proper amount of disinfectant and allow sufficient contact time
• Remember that the physical act of wiping is an important part of disinfection

Remember:

• There is no universal decontamination method for biological materials
• It is important to know and understand decontamination definitions
• Disinfection efficacy can be influenced by concentration, contact time, etc.
• Selection of an appropriate decontamination method may be a trade-off (the perfect disinfectant does not exist)

Biological Spill Preparedness in the Laboratory

Advanced preparedness and training for management of spills in the laboratory is essential. Spill kits should be strategically located throughout each laboratory section and should contain all items needed for the clean up to be performed expeditiously. Only trained staff should be responsible for spill clean-up.  

Biological Spill Kits Should Contain

• 1 gallon of undiluted EPA approved disinfectant
• 2 cloth towels (bath size or larger)
• Latex/ nitrile gloves
• Warning signs and tape
• Dust pan
• Autoclave bags
• Booties
• Tongs
• Spill dedicated bucket and mop

Biological Chemical Spill Cleanup Procedure

1. Immediately inform others working in the area of potentially infectious aerosols or other hazards. Clear the area if risk is unacceptable for workers to continue while spill is managed. Post spill warning sign. Report to Lab manager, supervisor, and safety officer. Clean-up should be initiated only by trained personnel who are properly donned with appropriate personal protective equipment.

2. If aerosols are possible, allow aerosols to be eliminated by air handling system by waiting 30 minutes before re-entering spill area to begin clean-up. If spill risk did not result in this step, proceed to step number 3.

3. Obtain spill kit.

4. Pour disinfectant into bucket after preparation according to manufacturer recommendation.

5. Immerse towels into bucket of disinfectant.

6. Place disinfectant soaked towels over spill.

7. Allow appropriate contact time (usually a minimum of 20 minutes, but follow disinfectant manufacturer’s directions).

8. If sharps are present under the towels, use long handled tongs to lift back the towel and transfer any broken glass/sharps, if present, to sharps containers. If not, skip to step number 9.

9. Transfer wet towels to large autoclave bag using long handled tongs.

10. Repeat the process of disinfection with cloth or paper towels as necessary.

11. Use the mop to wipe up excess disinfectant from surface, working from edges toward center of spill site.

12. Clean and decontaminate surrounding floor and work surface areas where splashes may have settled from the spill.

13. Don new pair of gloves and place all discard material in autoclave bag.

14. Close autoclave bag/s and place in appropriate secondary container ready for autoclave or for external vendor pick-up.

15. Be sure you notify and give a report to those in the vicinity during the spill and who managed the spill.

16. Depending on the nature of the spill, notification and a trip to occupational health may be required.

17. Perform a risk assessment and document the incident in order to allow the process to be examined for future efforts of prevention. 

Matrix Assisted Laser Desorption Ionization - Time of Flight – Mass Spectrometry (MALDI-TOF)

MALDI – Irradiation of the sample matrix by a laser produces ions

TOF – Electro-magnetic force is applied to the ions simultaneously, resulting in ionic acceleration in a flight tube. Ions travel through the flight tube at speeds based on mass. Lowest mass ions will reach the detector first - heaviest mass ions reach the detector last.

MALDI-TOF analysis creates a protein fingerprint spectra unique to the organism and the spectra is compared to a known spectral database for the organism identification. Prior to  implementation of the testing, a safety risk assessment should be completed for the MALDI-TOF instrumentation set up, use and clean up procedure. With the increasing use of MALDI-TOF technology it is important to be aware of safety and misidentification concerns.

Safety Considerations:

· Safe handling of organism isolate during sample preparation, extraction and target slide preparation including proper PPE (face shield) and / or engineering controls such as Class II Biosafety Cabinet (BSC)
· Proper PPE, use of fume hood and safe handling of hazardous chemicals such as Acetonitrile (ACN)
· Complete Inactivation of organism – verify inactivation protocols - some organisms may survive extraction method Avoid analysis of suspected high-risk infectious agents (Brucella spp., Francisella tularensis, Coxiella burnetii, etc.)
· Consult with LRN reference lab
· Look for trigger points prior to analysis on MALDI
· Follow ASM protocols for ruling out and referring potential select agents
· Gram stain and biochemicals
· Patient history- travel?

Missed Identification Concerns:

· Laboratories must be aware of software limitations
· Result limited by the database (library)
· Multiple libraries improve capability
· Beware of results that do not make sense – question
· Potential for exposure to highly infectious disease
· MALDI not reliable for identification of select agents

MALDI is cheaper, faster, and simpler than conventional microbial identification methods. It requires less labor and is generally accurate. It is important to educate those who are using this new technology to be aware of the limitations and be respectful of the potential safety hazards. 

MALDI-TOF Instrument Considerations

Does your lab have a Matrix Assisted Laser Desorption Ionization —Time of Flight, or MALDI-TOF, instrument? If you have one in use or plan to purchase one in the future, it is important to perform a biological risk assessment (2016) prior to testing. With increasing workload and staffing concerns in the microbiology laboratories MALDI is a very useful piece of equipment; however with any new technology there are safety concerns to be considered and mitigated.

During 2019 to date, 24 microbiologists have been exposed to either Brucella melitensis or Francisella tularensis during test procedures involving MALDI-TOF technology. Sentinel laboratory costs for post exposure surveillance and prophylaxis can add up quickly with multiple exposures. These exposures may have been avoided had American Society for Microbiology protocols  for handling bio-threat agents been followed. These guidelines include examination for trigger points by examination of growth characteristics, gram stain, biochemical reactions and patient history. Despite biosafety education, improved lab safety protocols, better engineering controls and biocontainment equipment laboratory acquired infections, or LAIs, continue to pose a risk. 

2018 Bio-threat Agent Sentinel Lab Benchcards

What do we do to make the Biosafety Cabinet ineffective?
1.   Walk past it
2.   Open a door near it
3.   Overcrowd it
4.   Cover the front grill
5.   Move hands in a sweeping motion through the sash opening (barrier)

How should we clean a spill in the Biosafety Cabinet?
1.   Leave the BSC running
2.   Cover spill with absorbent material
3.   Carefully apply effective disinfectant and allow appropriate contact time
4.   Flood the catch basin if contaminated
5.   Decontaminate objects within the BSC before removal
6.   Allow the BSC to run for 10 minutes before resuming work

What about the Ultra Violet light in the BSC?
1.   UV light is not recommended as the sole disinfectant for decontamination
2.   UV has limited penetrating power – surface or air only
3.   UV light intensity decreases with
       a. Time
       b. Dirt and Dust
       c. Distance from the bulb
4.   If you do not maintain the UV light bulb and use it correctly, it will not be as effective as you think!

For the safety of laboratorians, their family, and the laboratory, the use of any personal electronic device* should be prohibited in the technical work area of the laboratory under the following circumstances:

1.   During work with any category of hazardous materials,**
2.   If Personal Protective Equipment is being worn,
3.   During work on specimens or data or any process that may affect accuracy of results,
4.   During work in any area in which PED may distract or interrupt others,
5.   During work in any area in which accidental release of protected health information could occur,
6.   If PED cannot be worn without posing a hazard due to dangling wires or other accessories, and
7.   If PED interferes with the worker’s ability to detect potential hazards, such as an approaching obstacle or hearing an alarm

*Cell phones, portable music players, radios with headphones, personal digital assistants, test messaging or other wireless devices

**Chemical or Biological

Reference: Clinical Laboratory Standards Institute (CLSI) - GP17-A3 (Clinical Laboratory Safety) 5.5.3.1

 

The American Society for Microbiology has guidance on Laboratory Risk Assessment, Sentinel Laboratory Biosafety, Biosecurity and Biomedical Waste Management.

The Biosafety section includes guidance for MALDI-TOF MS Identification Systems, Molecular Identification Methods and Total Laboratory Automation in the microbiology lab. As more labs implement these cutting edge technologies, it is important that safety risk is carefully considered through an assessment prior to initiation of testing. Once risk assessment is completed and safety mitigation plans are approved, the plan should be written into the SOP. Training should include safety and competency to perform the test safely, and should be confirmed and documented.  

The Interim Clinical Laboratory Guidelines for Biological Safety (2019) may be downloaded free of charge from ASM .

Online and Downloadable Resources

TN Bio-threat Agent Bench Cards for the Sentinel Laboratory (2017) 

ASM Laboratory Response Network (LRN) Sentinel Level Clinical Laboratory Protocols

Clinical Laboratory Preparedness and Response Guide (2016)

Clicking the links below will direct you to an external site.  Training modules are maintained by the external site owners.

• Best Practices for Safe Operation of a Biological Safety Cabinet (BSC)
• Biosafety: Avoiding Lab Acquired Infections (LAI)
• APHL Packing and Shipping Infectious Substances Training Job Aid
• APHL Packing and Shipping Guidance for Biological Substances, Category B Specimens
• The Clinical Laboratory Ebola Response: Back to the Basics - A Review of Biosafety Practices (2014)
• CDC Guidance for Treating Malaria Smears (2014)
• TDH Laboratory Services Ebola Testing Letter (2014)
• CDC Laboratory Training

Presented by the Tennessee Department of Health, Division of Laboratory Services. 
Brought to you at NO CHARGE by the Public Health Emergency Preparedness Grant. 
Lunch Provided.  
Lodging and Travel Expenses are not covered.

COURSE DESCRIPTION
The Laboratory Response Network (LRN) workshop is a full-day, intermediate level workshop that covers a variety of laboratory topics geared for those working in sentinel laboratories. Presentation topics have been selected from suggestions from laboratorians all across the state.

AUDIENCE
This intermediate-level workshop is designed for Medical Laboratory Scientists and Medical Laboratory Technicians working in sentinel/microbiology laboratories. Admission preference will be given to those working in sentinel/microbiological laboratories in TN. 

PRESENTERS
·  Renee Johnson, MLS(ASCP), Bioterrorism Coordinator
·  Russell Bowden, MSHSA, MT, Outreach Coordinator
·  Julie Viruez, MLS(ASCP)CM, Training Coordinator
·  Amanda Uhls, M(ASCP)CM, Bioterrorism Lead Scientist

LOCATIONS/DATES 
(All workshops will be held from 8:30 am - 3:15 pm local time)
To be determined. 

REGISTRATION
Registration is required.  To register, click on the date listed above. Registration will close 2 weeks before the workshop date.

Limited seats are available for each date. Do not register for multiple dates.  Please contact TDH Lab Training (LabTraining.Health@tn.gov) to cancel or change your registration. 

CONTINUING EDUCATION
TDH Laboratory Services is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E. ® Program.  Attendees will receive 6.0 hours of  P.A.C.E. ®  CE for participation in this program. Partial credit will not be awarded. 

COURSE DESCRIPTION
This intermediate-level workshop focuses on practical methods that clinical microbiology laboratories can use to remain alert for the agents of bioterrorism. Participants will learn about surveillance and evaluation procedures that can be integrated into the routine work of the clinical microbiology lab. Procedures for the referral of suspect cases will also be discussed. In this hands-on course, following appropriate safety precautions, participants will examine actual cultures and organisms in a laboratory setting.

COURSE OBJECTIVES
At the end of this workshop, participants will be able to:

• Discuss the role of the clinical lab in discovering organisms targeted for use in acts of bioterrorism.
• Explain the safety implications of handling suspected organisms in clinical specimens and isolates.
• Describe  the clinical and laboratory features of the primary agents likely to be involved in a bioterrorist event, including anthrax, plague, botulism, tularemia, brucellosis, melioidosis and glanders.
• Recognize culture, staining and biochemical characteristics of bioterrorism organisms.
• Apply information presented in clinical scenarios in order to avoid identification pitfalls.
• Explain select agent regulations and their impact on clinical laboratories.

AUDIENCE
This intermediate-level workshop is designed for Medical Laboratory Scientists and Medical Laboratory Technicians working in sentinel/microbiology laboratories. Admission preference will be given to those working in sentinel/microbiological laboratories in TN.  

LOCATION
Nashville, TN

DATES (flyers)

• Friday, May 2, 2025 (flyer)
• Friday, October 10, 2025 (flyer)

REGISTRATION
Registration is required.  To register, click on the date listed above.  Registration will close 2 weeks before the workshop date.

Limited seats are available for each date.  Do not register for multiple dates.  Please contact TDH Lab Training (LabTraining.Health@tn.gov) to cancel or change your registration.

CONTINUING EDUCATION
TDH Division of Laboratory Services is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program.  Participants who successfully complete this program will be awarded 7.5 contact hours. Partial credit will not be awarded.  Program  Numbers, 429-101-25 and 429-102-25. 

Online Training: Packing and Shipping Dangerous Goods:  What the Laboratory Staff Must Know (CDC Lab Training)  

PHMSA Notice of Enforcement Policy Regarding International Standards - November 2022

TDH Infectious Substance Packing and Shipping Guidance  

• Category A Quick Guide (2022)
• Category B Quick Guide (2022)

U.S. DOT Hazardous Materials Outreach & Engagement

APHL  Packing and Shipping Guidance for Biological Substances, Category B Specimens

IATA Dangerous Goods Regulations

CDC  Packing and Shipping Job Aids

• DOT (Ground) Classification Job Aid (2022)
• Packing Category A, and B, and Exempt Human or Exempt Animal Specimens Job Aid (2022)
• Labeling, Marking, and Documenting Requirements Job Aid (2022)
• Shipping Papers Job Aid (2022)

SARS-CoV-2 Specimens

• Packing and Shipping Job Aid (2021)
• DOT Safety Advisory Notice for the Transportation of COVID-19 Diagnostic Samples (2020)

Infectious Substance Training Guidance

APHL Packing and Shipping Infectious Substances Training Requirements Job Aid (2022) 

NEW! IATA Dangerous Goods Training Guidance Effective 1/2023

U.S. Department of Transportation Hazardous Materials Outreach & Engagement

CDC Laboratory Training offers numerous on demand training modules.

Topics include: COVID-19, Diagnostic Testing, Preparedness, Core Science, Safety, Informatics, and Packing and Shipping.

CDC TRAIN is a gateway into the TRAIN Learning Network, the most comprehensive catalog of public health training opportunities.

TRAIN is a free service for learners from the Public Health Foundation.

CDC TRAIN provides access to more than 1,000 courses developed by the Centers for Disease Control and Prevention (CDC) programs, grantees, and other funded partners.

Courses offered by CDC course providers have been approved and verified by CDC.

New digital repository for online courses and some archived webinars. You can view and enroll in a range of free training courses, from Laboratory Ethics to Tuberculosis Specimen Handling. The portal tracks course progress and enables you to complete training on your own sch​​edule.

APHL offers educational opportunities including conferences, meetings, webinars, and workshops. On-demand training opportunities are also available.