Ebola Virus Information for Lab Professionals

 

(NOTE: Updated January 30, 2015)

 

Inquiries regarding suspect Ebola virus cases should be directed to the Wisconsin Division of Public Health at 608-267-9003 during office hours (M-F, 7:45 a.m. – 4:30 p.m.) and 608-258-0099 after hours and weekends.

 

The Wisconsin State Laboratory of Hygiene (WSLH) can perform the RT-PCR test for Ebola virus. This is the same test being performed by more than 40 state and local public health laboratories and the CDC.

 

Testing for Ebola virus infection MUST be approved by the Wisconsin Division of Public Health and the CDC. Please contact DPH at 608-267-9003 during office hours (M-F, 7:45 a.m. – 4:30 p.m.) and 608-258-0099 after hours and weekends.

 

DPH will work with healthcare facilities to have specimens delivered to the WSLH. Specimens MUST be accompanied by the following forms:

  • CDC submission form CDC 50.34 http://www.cdc.gov/laboratory/specimen-submission/form.html (NOTE: This form needs to be filled out on-line. Once form is completed, click the printer icon on the PDF toolbar at the top. A barcode will be automatically generated on the form. You can then save the form and print it off to accompany the specimens.)
  • WSLH requisition form CDD-A (NOTE: Hospital/clinical laboratories should already have this form.)

 

For more information, please read the 11/24/2014 DPH memo “WSLH is Now Approved to Test for Ebola Virus” (PDF).

 

 

Important guidance from Wisconsin Division of Public Health, CDC:

 

Wisconsin Division of Public Health

icon-pdfWSLH is Now Approved to Test for Ebola Virus – Issued November 24, 2014

 

Wisconsin Department of Health Services Ebola virus Information

 

Wisconsin Department of Health Services Ebola Response Webcasts

 

icon-pdfEbola Guidance Overview for Local Public Health Agencies — Issued December 16, 2014

 

CDC

Interim Guidance for Specimen Collection, Transport, Testing, and Submission for Patients with Suspected Infection with Ebola Virus Disease

 

Guidance for U.S. Laboratories for Managing and Testing Routine Clinical Specimens When There is a Concern About Ebola Virus Disease  (Updated 1/30/15 for clinical labs)

 

CDC Ebola Hemorrhagic Fever Information

 

 

Packaging and Shipping of Suspect Ebola specimens to the CDC

 

The WSLH can perform RT-PCR testing for Ebola virus. Suspect Ebola patient specimens will be delivered to the WSLH. The WSLH will test one specimen and send the second specimen to CDC for testing, if necessary.

 

Compliance with Regulations:

 

Each laboratory that packages and ships specimens is required to comply with U.S. Department of Transportation (USDOT) regulations when shipping by ground and International Air Transport Association (IATA) regulations when shipping by air. The regulations require each laboratory to have personnel certified in packaging and shipping for the types of specimens they ship. This information is not new and has been shared with Wisconsin clinical laboratories for several years. Suspect Ebola specimens should be shipped as a “Suspect Category A Infectious Substance”, so laboratories must have at least one person certified to package and ship Category A specimens.  

If you do not have staff who are certified in packaging and shipping in your laboratory, please see a list of vendors below that provide training in packaging and shipping.

Your laboratory is responsible for certifying your staff in packaging and shipping. In addition to maintaining packaging and shipping training records, you must keep records that you have provided training on all the other necessary components that are required for packaging and shipping certification. These include general awareness, function specific, safety, security awareness, and in-depth security training. You must also provide documentation that your employee is competent in each area of training required for packaging and shipping certification. Retraining and competency in packaging and shipping and each of the other areas required for packaging and shipping certification must be completed and documented every 2 years and whenever changes to the regulations occur. Failure to comply with packaging and shipping regulations may result in large fines for your facility.

 

Training Providers

NOTE: This is not an all-inclusive list of training providers, and inclusion on this list does not constitute an endorsement by the Wisconsin State Laboratory of Hygiene.

CDC/National Laboratory Training Network — https://cdc.train.org/DesktopModules/eLearning/CourseDetails/CourseDetailsForm.aspx?tabid=96&courseid=1052318&backURL=L0Rlc2t0b3BTaGVsbC5hc3B4P3RhYklkPTk2

Saf-T-Pak — http://www.saftpak.com/Training/training.aspx

HighQ, LLC. — http://www.highqllc.com/

JBM Associates, Inc., — Patricia Payne (in-person training only) – 859-608-3143

 

Specimen Transport:

 

Healthcare facilities should contact DPH to arrange transport of specimens from suspect Ebola patients to the WSLH. Specimens MUST be packaged as “Suspect Category A Infectious Substance”.

If you need to ship specimens for further testing to the CDC on a confirmed Ebola patient, World Courier will transport known Ebola specimens. The closest World Courier office is in the Chicago area. You can set up an account with World Courier by contacting them at 800-221-6600.

 

Specimen Shipping Guidance

 

CDC Interim Guidance for Specimen Collection, Transport, Testing, and Submission for Persons Under Investigation for Ebola Virus Disease in the United States

 

U.S. Department of Transportation (USDOT) — All applicable requirements of the U.S. Hazardous Materials Regulations (HMR) issued by the U.S. Department of Transportation (U.S. DOT) can be found on the DOT website (http://www.ecfr.gov/cgi-bin/text-idx?SID=2a97f2935677211e1785ac643163d2a9&node=49:2.1.1.3.10.5.25.33&rgn=div8). For questions on (packaging) transportation regulations, contact the U.S. DOT HazMat Information Center at 1-800-467-4922.

 

International Air Transport Association (IATA) — Dangerous Good Regulations identify proper packaging requirements for infectious substances affecting humans and animals in Packing Instruction 620 (PDF)

 

WSLHPictorial Guidance for Packaging and Shipping a Suspect Category A Infectious Substance to the WSLH for Ebola Testing (PDF) NOTE: This does NOT substitute for training.

 

Risk Assessment and Laboratory non-Ebola Testing

 

A question that is frequently being asked is “Can the WSLH provide guidance on what non-Ebola laboratory testing should be performed and whether it is safe to perform testing on routine laboratory equipment in the main laboratory?”

Unfortunately, we can’t give laboratories an exact list of tests that you should plan to perform. We also can’t tell you what testing can be safely done on your routine laboratory analyzers. This is because each patient will have different testing needs and each laboratory is unique. This is why you must work with a team at your facility to perform a risk assessment for your facility, your laboratory, and your staff. You must determine what the risks are at your facility and then find ways to avoid the risks or put measures in place to mitigate the risks. If you would normally refer this type of patient, or the patient’s laboratory testing to another facility, make sure you contact that routine partner and develop a plan with them for how you will refer a suspect or confirmed Ebola patient for care or testing.

 

Suspect Ebola Patient Testing Risk Assessment Resources:

 

APHLTemplate for Public Health Laboratory Risk Assessment for Ebola Virus Disease (EVD) Testing (This PDF document is labeled for public health laboratories but it may also be useful to clinical laboratories.)

 

CDC –  Guidance for U.S. Laboratories for Managing and Testing Routine Clinical Specimens When There is a Concern About Ebola Virus Disease  (Updated 1/30/15 for clinical labs)

 

American Society for Microbiology (ASM) Interim Laboratory Guidelines for Handling/Testing Specimens from Cases or Suspected Cases of Hemorrhagic Fever Virus (HFV)

 

CDC Interim Guidance for Specimen Collection, Transport, Testing, and Submission for Persons Under Investigation for Ebola Virus Disease in the United States