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Clinical Laboratories and Pathology Groups

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News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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Canadian scientist steals specimens, caught by U.S. Customs agent at the border

Laboratories are invariably out of the public eye—until there is a problem. In Canada, The Canadian Press reported earlier this year that audits had uncovered serious flaws in the tracking and accountability of dangerous pathogen specimens at federal laboratories. In response, the Public Health Agency of Canada (PHAC) called for increased security measures governing bio-safety at government laboratories.

These problems were identified at the nation’s National Microbiology Laboratory, located in Winnipeg. Earlier in the year, this lab played the lead role in testing swine flu (Novel A/H1N1) samples and mapped the progression of this flu strain from Mexico to Canada. Other labs visited and found lacking in full protection of pathogen specimens included the Laboratory for Foodborne Zoonoses in Guelph, Ontario, and federal satellite labs in Alberta and Quebec.

Public Health Agency of Canada recommended a standard system to track and account for pathogens and tightening of controls over who can access them

For pathologists and clinical laboratory administrators in North America and across the globe, the report of significant deficiencies in the handling, storage, and accounting of dangerous pathogen specimens is a reminder that long-standing business practices in laboratory management often fail to meet the new and tougher standards of a post-9/11 environment.

In response to these findings, the Public Health Agency of Canada recommended a standard system to track and account for pathogens and tightening of controls over who can access them. PHAC recommendations came after auditors noted that each lab has its own way of taking stock of dangerous pathogens. Additionally, some facilities use a mix of manual and electronic recording or tracking systems, which could result in samples going missing and/or being used for unscientific purposes.

There is growing concern about harmful pathogens falling into unfriendly hands. Earlier this year, 22 vials of biological material went missing from the National Microbiology Laboratory. A lab scientist allegedly stole vials containing safe traces of the Ebola gene in January. However, officials were unaware that these vials were missing until May. That’s when U.S. border authorities caught this scientist trying to smuggle them into the United States.

The missing vials with safe traces of the Ebola gene apparently went unnoticed for so long because they were mixed in with tens of thousands of vials of non-infectious materials in the National Microbiology Laboratory’s refrigerators and freezers. The lab director at that time, Frank Plummer, M.D., said high-level pathogens are subject to rigorous inventory, and workers who handle them are under strict security. For non-infectious materials, security was not as tight.

The PHAC audit noted that labs are following bio-safety guidelines, but measures could be enhanced. “Further study is required to ensure that samples (pathogens) destined for the laboratory environment are rigorously tracked from the time they are delivered to PHAC until they are transferred or destroyed,” noted the report.

The agency also found that labs need to do a better job of ensuring only high-security workers are assigned to restricted areas and classified information. “While there is considerable rigor in the process to control access, there is no evidence to indicate that …access levels assigned to individuals continue to be correct, and that the number of active access keys or cards corresponds to the number of individuals requiring access to any one facility,” noted the report.

Meanwhile, U.S. concern about bio-terrorism led to introduction of a bill in September that would step up security in American laboratories. It was introduced by Senators Joe Lieberman (ID-Connecticut), Chair of the Department of Homeland Security (DHS) and Governmental Affairs Committees, and Susan Collins (R-Maine). The bill calls for identifying the most dangerous pathogens, then requires the DHS to develop security standards for laboratories that handle those pathogens. The standards would address risk assessments, personnel reliability programs, and physical security. The bill also would improve U.S. prevention against—and preparedness for—an attack in an effort to minimize casualties and prevent mass destruction.

Clinical pathology laboratories may want to review the recommendations made by the Public Health Agency of Canada on how to handle, record, store, and track bio-specimens considered dangerous. Although, in the normal course of business, clinical labs don’t expect to see specimens of dangerous pathogens, there is always the potential for such a patient specimen to show up. After all, that’s how a Florida hospital emergency room diagnosed the first case of anthrax during the anonymous terrorist attacks involving that infectious agent which took place in the weeks after 9/11. – P. Kirk

Related Information:

Federal laboratories having difficulty accounting for pathogens: audit

Canadian accused of smuggling Ebola

Vials caught at border

Senate Committee Testimony

Lieberman, Collins Seek to Protect U.S. Against Biological and Other Terrorist WMD Attacks