Lab Samples and Suspect Cases

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How to Handle, Package, and Ship Specimens from High-Risk Patients

On November 22, 2022, NETEC hosted a webinar, “Lab Samples and Suspect Cases from High-Risk Patients,” to take a deep dive into frontline facility concerns for the packaging and shipping of specimens from higher-risk patients. When considering the prospect of a suspected or confirmed Category A infectious substance specimen, many facilities face challenges with maintaining trained staff, having adequate shipping materials on hand, identifying couriers, and more. Knowing how to manage a higher-risk patient, what classifies a specimen as Category A, and the requirements for safe packaging and shipping can prepare frontline health care facilities and workers for the possibility of a high consequence pathogen. Watch the webinar. Receive continuing education credits. 

Top 16 Takeaways for Lab Samples and Suspect Cases

1. A person under investigation (PUI) is typically defined as a person who is being monitored, investigated, or suspected to be infected with a higher-consequence pathogen, like Ebola virus, measles, anthrax, tuberculosis, mpox, etc. Learn more about some of the highest-consequence pathogens: viral hemorrhagic fevers.  

2. Facilities should follow the identify, isolate, and inform strategy to manage PUIs:
   • Identify: screen all patients for symptoms and travel history or exposure to identify a potential infection with a special pathogen;
   • Isolate: protect yourself and others by placing suspect patients into private rooms when available and using the appropriate personal protective equipment (PPE); and
   • Inform: involve internal stakeholders and public health partners early on to determine PPE, infection prevention and control (IPC), testing, treatment, and transfer options.

3. Pathogens are classified into risk groups 1 through 4 based on the risk presented by an organism to human or animal health, with risk group 4 (RG 4) being the highest risk category. Category A pathogens for shipping purposes typically fall under risk groups 3 and 4. Category A pathogens are defined as being able to cause permanent disability or life-threatening or fatal disease to otherwise healthy humans or animals that are exposed to the infectious substance.

4. The Department of Transportation (DOT) and the Centers for Disease Control and Prevention (CDC) follow the World Health Organization (WHO) in their guidelines for transporting infectious substances, which includes an indicative list of organisms that are classified as Category A. Guidance can be found on the WHO website, or by calling your public health lab.

5. Specimens collected from PUIs are typically classified as Category A or Suspected Category A for shipping purposes because they are collected from patients suspected to be infected with a higher-consequence pathogen.

6. Classification as Category A versus Suspected Category A, and Category A versus Category B will depend on several factors and especially the professional judgement of the shipper:  
   • Specimen type: Specimen type, or the form a specimen is in (e.g., culture or primary patient specimen) will be critical information for a shipper to determine if their specimen should be classified as a Category A, Infectious Substance or Category B, Biological Substance. Specimens will typically either be in a “culture” form or still in a primary patient specimen form, like whole blood or stool. Cultures are defined as pathogens that are intentionally propagated. 
   • Specimen Classification: 
     • Suspected pathogen not Category A: If the suspected pathogen/organism within the specimen to be shipped does not appear on the Category A classification list, does not meet the definition of Category A, or is an emerging pathogen, the infectious specimen may be classified and shipped as Biological Substance, Category B.  
       • If an infectious substance is not on the Category A list but meets the same criteria it must be assigned to Category A. Meaning, if the shipper determines the suspected pathogen/organism within the specimen meets the DOT definition and criteria of a Category A infectious substance for shipping purposes, but the suspected pathogen does not appear on the Category A indicative list, the shipper would be expected to classify and ship the specimen as Category A (e.g., Coccidioides posadasii). Category A pathogens for shipping purposes are defined as pathogens that can cause life-threatening or other severe disease to otherwise healthy humans or animals if exposure to it were to occur.
     • Category A Specimen in Culture: If the specimen to be shipped is in a culture form, and if the correlated organism within the culture appears on the Category A list, it must be classified as Category A. The Category A classification list will identify this by including the words “cultures” or “cultures only” after the pathogen name. Frontline facilities shipping PUI specimens would typically not be shipping cultures but that may depend on the facility’s laboratory capabilities and level of specimen workup at time of shipping.
       • For example, Mycobacterium tuberculosis appears on the Category A list as “Mycobacterium tuberculosis (cultures only),” therefore all cultures of Mycobacterium tuberculosis will need to be classified as Category A, whereas patient specimens of suspected or confirmed Mycobacterium tuberculosis may be classified as Biological Substance, Category B because only propagated cultures would be required to be classified as Category A.  
     • Category A Primary Patient Specimen: If the suspected organism within the PUI primary patient specimen (not culture) appears on the Category A classification list, and the listed pathogen/organism name does not indicate the word “cultures” or “cultures only” afterward, the specimen will be classified as Category A, Infectious Substance for shipping purposes. 
       • For example, Ebola virus appears on the Category A list as: “Ebola virus” and does not have the words “cultures” or “cultures only” afterwards. Therefore, primary patient specimens suspected to contain Ebola virus will need to be classified as Category A. (As a reminder, a culture of Ebola virus would also be required to be classified and shipped as Category A). 
   • Test results: The type and level of testing (e.g., point of care, differential, diagnostic or reference laboratory confirmatory), and the test results can factor into a shipper’s designation to classify specimens as a Category A or Suspected Category A, or possibly Category B. Specimen testing provides the shipper with information about potential/suspected organism(s) that may be within the specimen.  
     • Because a PUI specimen would not be considered a “confirmed” Category A agent at the time that it is being sent to a reference lab for diagnostic testing it’s extremely unlikely a frontline facility would have a “confirmed” select agent. Specimens would only be “suspected” at this point until rule-out or confirmatory testing is conducted.  
   • Patient medical history: Relevant symptoms, recent travel or exposure history, endemic local conditions, or individual circumstances of the patient can all influence the shipper’s classification determination. 

7. Regardless of whether an infectious substance is classified as Suspected Category A or Category A, the same triple packing requirements for the package and transport will apply. 

8. Packaging: Category A packaging must:  
   • Be UN certified, using only manufacturer provided inner components. 
   • Be able to withstand significant content leakage, shocks, temperature changes, pressure changes, and other conditions that can occur during transport. Packaging specifications are outlined by DOT for both Category A and B shipments going by ground, and by the International Air Transport Association (IATA) for transport by air.  
     • Infectious shipments going by air must conform to both DOT and IATA regulations.  
   • Use the triple packaging system, consisting of minimum three layers:  
     • Leak-proof primary container  
       • Typically, this will be the actual specimen test tube  
     • Sufficient absorbent material between primary and secondary containers 
     • Leak-proof secondary container 
       • Often either a hard-sided inner container with twist lid, or a sealed specimen transport bag 
     • Secondary packaging consisting of cushioning material  
   • Have appropriate labels, marking, associated records, and emergency response information.  
   • Be packaged and shipped only by currently trained staff.  

9. Packing the specimen: 
   • Packaging often may begin in the actual patient isolation space and includes multiple disinfection steps not normally performed in routine patient collection.  
     • Collect specimen directly into an appropriate leak proof container. 
     • Perform surface decontamination of specimen tube using appropriate disinfectant wipe (spray not recommended).
     • Surround with sufficient absorbent material and place inside leak proof secondary container.  
     • Decontaminate outside of secondary container prior to handing outside the patient isolation space. 
     • Hand outside room touching only with a disinfectant wipe. 
   • Tertiary/outer packaging (the actual cardboard UN certified shipping box) will then typically be completed immediately outside of patient room to minimize the distance the specimen will need to move before it can be safely packed for shipping.  

10. Shipping method: There are differences in packing requirements when shipping infectious material by air versus ground: 
    • Following the stricter requirements for air transport (IATA, packing instruction 620) will generally help the shipper comply with all DOT Hazardous Material requirements for ground transport. 
    • Identify the location of your reference laboratory to determine whether shipping will be by ground or air. 

11. Labeling, marking, and other records/documents: Packaging must be marked, labeled, and accompanied by all appropriate shipping documents when complete.  
    • A Class 6 Infectious Substance label. 
    • Either a UN2814 or UN2900 hazard identification label.  
      • For PUI specimens, both Suspect Category A and Category A packages must be labeled on the outside with “UN2814 Infectious Substance, Affecting Humans.”  
    • Records/documents 
      • Category A shipments transported by ground are required to have “Shipping Papers” according to DOT, which provide critical information about the material being shipped, such as whether the material is in liquid or solid form, the quantity of hazardous material, and contact information. 
      • For the “technical name of the organism” for shipping:  
        • “UN2814 Infectious Substance, Affecting Humans (suspected Category A Infectious Substance)”
    • The shipper’s and recipient’s full names, complete addresses, and phone numbers. 
    • Emergency response information: A responsible person’s name and number and a 24-hour emergency contact. 

12. Couriers and carriers: Currently FedEx and UPS are the only common commercial carriers that will accept and ship Category A (however they will not accept risk group 4 confirmed pathogens, i.e., Ebola virus specimens). Private ground couriers can be used so long as they are vetted by the shipper, trained, reputable, and document in a legal contract their acceptance of these hazardous materials. 
    • Notify courier or carrier that they are transporting hazardous material. 
    • Transporters must be trained in hazardous material recognition and incident response and communication. 
    • Note: Very few commercially available couriers will transport confirmed select agents, or any identified risk group 4 pathogens within specimens. 

13. There may be exemptions or additional guidance provided from the DOT shipping regulations during public health emergencies (e.g., clarification about shipping mpox specimens). Under these circumstances, hospitals should follow current guidance and consult with their state or local health departments as needed. Exemptions or other guidance from DOT will likely be to assist the shipper with making proper classification of their specimens for shipping purposes and will most likely NOT relax any of the hazardous material requirements for packaging or training.  

14. Special Transport Assistance Provision: The DOT regulations permit the transport of hazardous material by local, state, or federal law enforcement or public health officials for the express use of circumstances specifically allowed by regulation (e.g., transport specimen to assist with diagnostic or epidemiological surveillance purposes, etc.). In areas where there may be significant challenges for transporting suspected PUI Category A specimens, frontline facilities should discuss any potential options with their local or state health departments to explore any possibilities to use an “alternate” emergency use courier such as a member of law enforcement or other public health official to provide transport assistance. Note: This level of assistance would require significant planning and agreed upon cooperation before it would be permitted. Frontline facilities should discuss any intended transport plans with an intended recipient reference lab and health department if any other method besides a typical commercial courier would be used.  Permission for using this special provision must be granted ahead of time by state officials. 

15. Employees must be currently trained and certified to classify, package, and ship Category A specimens. Training may be accomplished in many formats, but certification will ultimately be provided by the employer and the employer is required to maintain a competency program to account for Category A packaging and shipping at the facility.

16. If your facility may encounter a PUI and need to ship a Category A specimen:
    • Develop a plan for high-risk / high-consequence specimen shipping: 
      • Ensure it is reviewed and tested appropriately with all interested parties. 
      • Ensure an appropriate reference laboratory has been identified (e.g., State Public Health Laboratory / Laboratory Response Network (LRN) Reference Laboratory). Commercial Reference Labs will likely NOT accept specimens from PUI for any type of higher risk testing. 
    • Communicate early and obtain approval from State/CDC EOC prior to collection 
    • Have Category A shipping materials / supplies on-hand 
    • Have an adequate number of staff currently trained and effectively exercised to ship Category A specimens 
    • Have an intended courier or carrier, and a backup if necessary  
      • Ensure their capabilities for Category A transport 
    • Ensure proper communication:  
      • Internally with key members of your facility 
      • With state and/or local health departments 
      • With couriers/carriers 
      • With recipient laboratory 
      • Have an intended ‘Responsible Person’ and 24-hour emergency contact