CDC labs repeatedly faced secret sanctions for mishandling bioterror germs

By Alison Young, USA TODAY

A laboratory operated by the Centers for Disease Control and Prevention is among the handful of facilities that have secretly had their permits suspended in recent years for serious safety violations while working with bioterror pathogens, according to documents obtained by USA TODAY after winning a Freedom of Information Act appeal.

The CDC’s own labs also have been referred for additional secret federal enforcement actions six times because of serious or repeated violations in how they’ve handled certain viruses, bacteria and toxins that are heavily regulated because of their potential use as bioweapons, the CDC admitted for the first time on Tuesday. Before USA TODAY won access to records of the lab suspension, the CDC had repeatedly refused to answer questions about its own labs’ enforcement histories.

The revelations show the CDC’s facilities are among a small group of biolab operators that have the worst regulatory histories in the country, receiving repeated sanctions under federal regulations.

Citing security reasons and a federal bioterrorism law, the names of labs that have been suspended or faced other enforcement actions have been a closely guarded secret by the CDC and the U.S. Department of Agriculture. The two agencies not only operate high-security biolabs, but they also co-run the Federal Select Agent Program that regulates government, university, military and private labs that work with bioterror pathogens such as anthrax, plague and Ebola. The government calls these kinds of pathogens “select agents.”

Only five labs have been suspended from the Federal Select Agent Program since 2003 and another five labs have faced repeated referrals for enforcement actions, according to information the CDC provided last year to USA TODAY and later to congressional investigators. The revelation that CDC’s own labs are among these small groups that have faced serious and repeated sanctions raised questions among some lab safety watchdogs about the agency’s secrecy motives.

“There is no security rationale for withholding the identities of the suspended labs,” Richard Ebright, a biosafety expert at Rutgers University in New Jersey who has testified before Congress. “The sole rationale is a CYA rationale, in which the CDC seeks to cover its derriere by covering up violations and shielding staff and management responsible from accountability for violations.”

A heavily redacted USDA letter obtained by USA TODAY shows a CDC-operated lab was suspended from doing select agent research around 2007 and reinstated in 2010 because of federal violations in the handling and transfer of a virus. The USDA blacked out the name of the virus.

The CDC said Tuesday the suspension involved an individual lead scientist and the labs associated with that scientist’s research, which was located at the agency’s lab complex in Fort Collins, Colo. The violations involved research with Japanese encephalitis virus, which can cause a deadly inflammation of the brain and is often transmitted by mosquitos. As a result of the USDA inspection and findings that the research was not in compliance, the remaining samples of the virus were destroyed or transferred to another facility that was registered to possess them. The CDC noted in its statement that as of 2012, Japanese encephalitis virus was no longer considered by the federal government to be a select agent.

In response to USA TODAY’s questions about how many CDC labs have faced select agent sanctions, the CDC said its own labs have been referred six times since 2003 to the Office of Inspector General at the U.S. Department of Health and Human Services, which handles enforcement actions for select agent violations.

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PositiveID to Exhibit its Caregiver Non-Contact Thermometer at the American Association of Critical-Care Nurses Exposition May 16-19 –

Caregiver, FDA-cleared for clinical use, reduces the risk of cross-contamination and costs for healthcare facilities
DELRAY BEACH, Fla., May 10, 2016 (GLOBE NEWSWIRE) — PositiveID Corporation (“PositiveID” or “Company”) (OTCQB:PSID), a life sciences company focused on detection and diagnostics, announced today announced that its Thermomedics subsidiary will exhibit the FDA-cleared Caregiver® non-contact thermometer at the American Association of Critical-Care Nurses (“AACN”) National Teaching Institute and Critical Care Exposition from May 16-19, at the New Orleans Ernest N. Morial Convention Center in New Orleans, LA.

Caregiver is a clinical grade, infrared thermometer for measurement of forehead temperature in adults, children, and infants, without contact. It delivers an oral-equivalent temperature directly from the forehead in one to two seconds. Since there is no skin contact and Caregiver does not require probe cover supplies, it reduces the risk of cross-contamination, which is an increasing concern, and saves healthcare facilities the cost of covers (as much as $0.05 to $0.10 per temperature), storage space, and waste disposal costs. It is estimated that Caregiver can offer savings of $250 or more per year per device in probe cover supplies alone.

PositiveID’s Thermomedics team is featuring Caregiver at the AACN exposition to increase exposure and awareness for Caregiver and immediately generate qualified leads for dealer follow up.

The AACN National Teaching Institute and Critical Care Exposition is the largest and most comprehensive trade show for high acuity and critical care nurses. The turnout at last year’s exposition was estimated at 7,000 attendees. AACN, a 501(c)(3) nonprofit association, is the largest specialty nursing organization in the world, representing the interests of more than 500,000 nurses who are charged with the responsibility of caring for acutely and critically ill patients.

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The Impact of Microfluidics/Lab-on-a-Chip Technologies on the Development of the POC Dx Markets | Insight & Intelligence™ | GEN

Over the past decade we have been observing a steady increase in interest in microfluidics and lab-on-a-chip technologies.  This increase has been driven in large part by the plethora of applications that are being developed utilizing microfluidics-based approaches. We sought to understand and quantify expanding interest in the microfluidics and lab-on-a-chip space by examining the entire publications landscape of this field and seeking to understand the utilization of microfluidics and lab-on-a-chip technologies in the development of point-of-care (POC) diagnostics and global health.

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GOP Lawmakers Slam Obama Plan to ‘Raid’ Bioterror Fund for Zika

April 28 — The Obama administration’s plan to “raid” medical countermeasures funding to combat the Zika virus may deplete the U.S.’s ability to respond to bioterror threats, Republican lawmakers said in an April 28 letter.

The administration’s proposal “risks further damaging fragile public-private partnerships by eroding confidence in the federal government’s commitment to procure medical countermeasures,” the letter to Health and Human Services Secretary Sylvia M. Burwell said.

It asked that the legislative proposal to change the requirements for procuring money from the BioShield Special Reserve Fund (SRF) be removed from President Barack Obama’s Zika emergency funding request. The letter was signed by House Energy and Commerce Committee Chairman Fred Upton (R-Mich.); Rep. Susan Brooks (R-Ind.); Senate Health, Education, Labor and Pensions Committee Chairman Lamar Alexander (R-Tenn.); and Senate Select Committee on Intelligence Chairman Richard Burr (R-N.C.).

An HHS spokesman didn’t respond to Bloomberg BNA’s e-mail request for comment.

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