Anthrax Report Released

By Tony Bertuca / July 23, 2015 at 4:09 PM

The Pentagon released a report today detailing the findings of its investigation into how live samples of anthrax were inadvertently sent from a Defense Department lab at Dugway Proving Ground, Utah, to 86 locations worldwide.

Some of the report's key findings include:

-The root cause for the incomplete inactivation of [Bacillus anthracis] samples at DoD laboratories:

A single root cause for shipping viable BA samples could not be identified. DoD personnel appear to have followed their own protocols correctly. However, the committee found inherent deficiencies in protocols for three phases in the production of inactive spores that could lead to non-sterile products: 1) radiation dosing, 2) viability testing, and 3) aseptic operations (contamination prevention). These deficiencies and other factors5 contributed to the establishment of protocols that do not completely or permanently sterilize these samples.

-Why post inactivation viability testing did not detect the presence of live BA:

There is no single root cause to explain why the BA samples were incompletely inactivated, or why viability testing did not detect live BA spores. Contributing factors that may have resulted in undetected live BA spores during viability testing in DPG’s samples include deficiencies in sample sizes and inadequate incubation periods after irradiation.

-Existing DOD laboratory biological safety protocols and procedures:

The committee identified existing DoD laboratory safety protocols and procedures in each location. However, these procedures are not standardized amongst the laboratories.

-DOD laboratory adherence to established procedures and protocols:

In most cases, the committee observed that DoD laboratories followed their own established procedures and protocols.

-Identification of systemic problems and what steps should be taken to fix those problems:

The primary systemic issue responsible for failures in the preparation of inactivated BA spores is the lack of specific validated standards to guide the development of protocols, processes, and quality assurance measures.

Meanwhile, some of DOD's recommendations include:

-Quality Assurance: Enhance quality control programs at DOD laboratories working with hazardous select agents and other pathogens.

-Standardize BA Inactivation Protocols Across Laboratories: All DoD laboratories should follow a common Standard Operating Procedure (SOP) for such practices as irradiation and viability testing.

-Institute More Rigorous Quality Procedures: Establish quality assurance (QA) and quality control (QC) procedures for inactivation and viability testing of BA spores.

-Clarify The Conditions Of The Material Transfer Agreement (MTA): Material transfer agreements enable DoD laboratories to communicate potential hazards to the customers and maintain a positive inventory tracking for potential recalls on all select agent inactivated materials.