Labs Urged to Coordinate With CDC on Ebola Testing

by Glenn S. Demby | Feb 25, 2015 | CLIA-nir, CMS-nir, Compliance-nir, Essential, FDA-nir, National Lab Reporter

The Centers for Medicare and Medicaid Services (CMS) is urging clinical laboratories to coordinate with the Centers for Disease Control and Prevention (CDC) and state public health laboratories before handling Ebola specimens. In a Nov. 7 memo sent to state survey directors, CMS notes that CDC has issued interim guidance for “specimen collection, transport, testing, and submission for persons under investigation for Ebola virus disease in the United States.” Among the key points in the CDC specimen guidance: Clinical laboratories can safely handle specimens from potential patients by taking all required precautions and practices in the laboratory specifically designed for pathogens spread in the blood; Risk assessments should be conducted by each laboratory director, biosafety officer, or other responsible person to determine the potential for sprays, splashes, or aerosol generated during laboratory procedures; Any person collecting specimens from a patient with suspected Ebola virus disease should wear appropriate personal protective equipment; and Anyone collecting specimens from a patient should follow the procedures listed in the guidance for transporting them through the health care facility, clean-up of spills, storing, packaging, and shipping to CDC for testing. If surveyors determine that a survey must be conducted, surveyors are expected to assess compliance […]

The Centers for Medicare and Medicaid Services (CMS) is urging clinical laboratories to coordinate with the Centers for Disease Control and Prevention (CDC) and state public health laboratories before handling Ebola specimens. In a Nov. 7 memo sent to state survey directors, CMS notes that CDC has issued interim guidance for “specimen collection, transport, testing, and submission for persons under investigation for Ebola virus disease in the United States.” Among the key points in the CDC specimen guidance:

Clinical laboratories can safely handle specimens from potential patients by taking all required precautions and practices in the laboratory specifically designed for pathogens spread in the blood;
Risk assessments should be conducted by each laboratory director, biosafety officer, or other responsible person to determine the potential for sprays, splashes, or aerosol generated during laboratory procedures;
Any person collecting specimens from a patient with suspected Ebola virus disease should wear appropriate personal protective equipment; and
Anyone collecting specimens from a patient should follow the procedures listed in the guidance for transporting them through the health care facility, clean-up of spills, storing, packaging, and shipping to CDC for testing.

If surveyors determine that a survey must be conducted, surveyors are expected to assess compliance with only the Clinical Laboratory Improvement Amendments, the memo instructs. “The laboratory director is ultimately responsible for the physical plant and environmental conditions under which testing is performed,” it says. “All CLIA regulations remain in effect and all individual state protocols must be met. Specific questions about device decontamination should be directed to specific manufacturers and CDC.” Takeaway: Laboratories should work closely with the CDC and state public health laboratories as they prepare for the possibility of handling Ebola specimens. Side Box: Ebola Resources

CDC guidance for specimens and personal protective equipment is available at http://www.cdc.gov/vhf/ebola/hcp/interim-guidance-specimen-collection-submission-patients-suspected-infection-ebola.html.
CDC Ebola virus disease information and updates are available at http://www.cdc.gov/vhf/ebola/index.html.
Occupational Safety and Health Administration Ebola guidelines are available at https://www.osha.gov/SLTC/ebola/.
FDA test system information is available at http://www.fda.gov/EmergencyPreparedness/Counterterrorism/MedicalCountermeasures/UCM410308.htm.

Labs Urged to Coordinate With CDC on Ebola Testing

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