1. Select Agent Rule Out Testing
This Select Agent Rule Out Testing course is presented by the LabCorp Corporate Environment, Health and Safety (EHS) Department and the routine microbiology discipline directors. It has both voice recordings as well as written notes. To see the notes, click the “notes” tab on the right hand side. To advance to the next slide, click the “Next” button. To go back to a slide in the presentation, either click on the slide or click the “Previous” button. If you have any questions, contact your EHS Officer.

2. Applicability
This course applies to routine microbiology technicians and technologists who must perform Select Agent Rule Out Testing before they can perform routine microbiology specimen testing.
This course applies to routine microbiology technicians and technologists who must perform Select Agent Rule Out Testing before they can perform routine microbiology specimen testing.

3. Select Agent Rule Out Testing – EHS Considerations
Select Agents are capable of producing airborne transmissible disease in humans.
Routine microbiology testing procedures are capable of generating aerosols that are capable of transmitting disease.
Some Select Agent Rule Out test procedures are also capable of producing infectious aerosols.
Many Select Agents have been documented as causing laboratory acquired infections.
Select Agents are capable of producing airborne transmissible disease in humans.
Routine microbiology testing procedures are capable of generating aerosols that are capable of transmitting disease.
Some Select Agent Rule Out test procedures are also capable of producing infectious aerosols.
Many Select Agents have been documented as causing laboratory acquired infections.
Brucella sp. have caused more infections in clinical laboratories than any other Select Agent.
Brucella sp. have caused more infections in clinical laboratories than any other Select Agent.

4. Select Agent Rule Out Testing – Technical Considerations
Select Agents can be isolated in specimens received and tested.
Because they are uncommonly isolated, they can be difficult to recognize when encountered.
It’s very likely that technicians and technologists have not previously seen these pathogens in the laboratory in their formal academic training.
In order to protect yourself and your co-workers from these infections, it’s important to have a systematic approach to presumptively identifing these pathogens.
Select Agents can be isolated in specimens received and tested.
Because they are uncommonly isolated, they can be difficult to recognize when encountered.
It's very likely that technicians and technologists have not previously seen these pathogens in the laboratory in their formal academic training.
In order to protect yourself and your co-workers from these infections, it's important to have a systematic approach to presumptively identifing these pathogens.
The American Society for Microbiology has prepared and shared algorithms to guide Select Agent rule out testing. LabCorp has used this guidance to prepare its Select Agent rule out testing guidance
The American Society for Microbiology has prepared and shared algorithms to guide Select Agent rule out testing. LabCorp has used this guidance to prepare its Select Agent rule out testing guidance.

5. Applicable Technical SOPs

6. Applicable EHS Policies and SOPs

7. Applicable EHS Training

8. CDC Select Agents
Bacillus anthracis
Brucella species
Burkholderia mallei
Burkholderia pseudomallei
Francisella tularensis
Yersinia pestis
The specific Select Agents which may be encountered in clinical specimens which are considered in LabCorp Select Agent Rule Out Testing procedures are:
Bacillus anthracis,
Brucellea species,
Burkholderia, specifically Burkhholderia mallei and Burholderia psuedomallei,
Francisella tularensis, and
Yersina pestis
We’ll describe the morphology, gram stains, and biochemical test results that are characteristic of these pathogens.
You can also find in the “Resources” tab on this presentation bioterrorism information cards from Wadsworth Medical Center of New York, the state public health laboratory. They provide technical information regarding the characteristics of these organisms. You can also find them posted on the Corporate EHS intranet site.

9. Bacillus anthracis

10. Brucella Species

11. Burholderia Mallei

12. Burkholderia Pseudomallei

13. Franciscella tularensis

14. Yersinia Pestis

15. Test Requests

16. X Select Agent Confirmation Testing And LabCorp Reference Laboratories
LabCorp reference microbiology laboratories do NOT conduct Select Agent confirmation testing.
Under no circumstances is any suspected bioterrorism/select agent to be forwarded to a LabCorp reference microbiology laboratory for confirmatory testing.
LabCorp reference microbiology laboratories do NOT conduct Select Agent confirmation testing.
Under no circumstances is any suspected bioterrorism/select agent to be forwarded to a LabCorp reference microbiology laboratory for confirmatory testing.
These and any suspicious organisms are to be sent to the appropriate public health laboratory for this testing and not to any LabCorp reference microbiology laboratory.
These and any suspicious organisms are to be sent to the appropriate public health laboratory for this testing and not to any LabCorp reference microbiology laboratory.

17. Rule Out Procedure Detail : Steps 1 -3
Don Personal Protective Equipment
Place Specimen in Biological Safety Cabinet
Perform Gram Stain (in BSC)
You begin the Select Agent rule out procedures by donning the appropriate personal protective equipment, which consists of disposable gloves and a lab coat.
This is to be followed by placing the specimen inside of a biological safety cabinet.
The gram stain is then performed, while the specimen is still inside the biological safety cabinet.

18. NOTE: Specimen Remains in Biological Safety Cabinet
Rule Out Procedure Detail : Step 4-5
4. Read and Interpret Gram Stain
5. Apply Algorithm
NOTE: Specimen Remains in Biological Safety Cabinet
The gram stain must be read and interpreted.
Colony morphology and characteristics need to be determined and assessed.
Once the outcomes of these tasks are completed, the algorithm can be applied. These steps are driven by the gram stain results and colony morphology, so it’s important to get these steps right.
Also important is the fact the specimen is the remain in the biosafety safety cabinet until all Select Agent rule out testing has been completed.

19. Apply Algorithm Steps
Gram Positive Cocci
No further rule out testing is required
Gram Negative Cocci
Rule out Neisseria meningitides
Gram Positive Rods NOT resembling Bacillus species
No further rule out testing required
Gram Positive Rods Resembling B. anthracis
Rule out B. anthracis
Gram Negative Rods
Rule out Y.pestis, B.mallei, B.pseudomallei, Brucella species, and F. tularensis
If the gram stain reveals gram positive cocci, then no further Select Agent rule out testing is required. Routine identification procedures can be used for these isolates.
If the gram stain reveals gram negative cocci, then rule out testing for Neisseria meningitides is required. Although this is not a Select Agent, the rule testing for this organism still should be done in a biological safety cabinet.
If the gram stain reveals gram positive rods NOT resembling Bacillus species then no further rule out testing is required. Routine identification procedures can be used for these isolates.
If the gram stain reveals gram positive rods resembling Bacillus anthracis, then further testing is required to rule out Bacillus anthracis.
If the gram stain reveals gram negative rods, then Select Agent testing is required to rule out Yersina pestis, Burkholderia mallei, Burkholderia pseudomallei, Brucella species, and Franciscella tularensis.

20. Gram Positive Rods Resembling Bacillus Species

21. Gram Negative Rods

22. Diagram II

23. LPX Surveys
The College of American Pathologists, known as CAP, administers a laboratory proficiency testing survey, commonly known as the LPX survey.
This survey tests to competency of clinical microbiologists to correctly read and interpret many common clinical pathogens.
Surrogate organisms to Select Agents are included in the survey. A good example would be Bacillius cereus as a test sample instead of Baccillus anthracis.
The College of American Pathologists, known as CAP, administers a laboratory proficiency testing survey, commonly known as the LPX survey.
This survey tests the competency of clinical microbiologists to correctly read and interpret many common clinical pathogens.
Surrogate organisms to Select Agents are included in the survey. A good example would be Bacillius cereus as a test sample instead of Baccillus anthracis.
LabCorp laboratories with clinical microbiology departments are strongly encouraged by the routine microbiology discipline directors to participate in this program.
LabCorp laboratories with clinical microbiology departments are strongly encouraged by the routine microbiology discipline directors to participate in this program.

24. Select Agent Rule Out Testing