After intensive review by CDC’s internal Laboratory Safety Improvement Working Group (internal working group), CDC Director Tom Frieden, MD, MPH, has lifted the moratorium on a specific type of material transfer for the CDC’s Clinical Tuberculosis Laboratory. The moratorium remains in place for other high-containment (BSL-3 and BSL-4) laboratories. Labs supporting direct patient care are receiving priority review.
The BSL-3 Clinical TB Lab uses a “heat kill” process to inactivate tuberculosis bacteria isolated from patients. It then sends the killed bacteria to a lower-level BSL-2 CDC lab for genetic analysis, rapidly telling clinicians whether their patients carry multi-drug-resistant strains of tuberculosis and which drugs will be most effective. Old tests took weeks to yield results; the new test takes only two days.
The plan submitted by the TB lab to the internal working group details safety procedures for each step of the TB inactivation process. The plan includes risk assessment; rules for personal protective equipment; validation (including observation of key steps by a second, highly trained, and certified lab technician) that the heat-kill process was conducted correctly and that any living organisms were killed; strict limits on lab access; medical monitoring of lab personnel; and back-up tests. The lab is and has been certified under Clinical Laboratory Improvement Amendments (CLIA) federal standards, and its testing results and quality control are reviewed in real time by a CLIA technical supervisor. The TB lab was not one of the two labs involved in recent anthrax and smallpox-related incidents; those labs remain closed. Learn more from a related NBC News report.Read more