Findings and recommendations
Four years ago this month, the U.S. Army Medical Research Institute of Infectious Diseases discovered anthrax spores outside of the containment area.
The U.S. Army Medical Research and Materiel Command, which oversees USAMRIID, conducted an investigation. The Frederick News-Post obtained the Army's 361-page report on the 2002 breach of containment through a Freedom Of Information Act request.
Below are the Army's findings and recommendations:
Report of Investigation findings- pg. 9
A. Contamination of USAMRIID [U.S. Army Institute of Infectious Diseases] Building 1425, with Bacillus anthracis (Sterne, Vollum 1B and Ames strains) was first officially suspected on April 16, 2002. Anthrax contamination was confirmed on April 18, 2002 and strains determined on May 8, 2002.
B.
1) USAMRIID has a comprehensive system of procedures at the Institute level that, if fully implemented, would protect the great majority of personnel from exposure.
Some procedures need to be updated.
Eating and drinking are permitted in the offices within the containment suites. There is no requirement for routine surveillance for contamination either within or outside of the containment laboratories.
The Special Immunizations Program in the Division of Medicine provides immunizations if available and assesses personnel who have potential or actual exposures to etiologic agents
A comprehensive safety manual has been adopted, although some portions have not been revised since 1990.
Divisions perform inspections monthly and the Safety Office performs them quarterly
USAMRIID regulation 385-69 permits eating, drinking and food storage in office areas located within the BSL-3 containment suites. In Building 1425, the ultraviolet light passboxes used to send documents and small items out are located within this office area. In Building 1412, a break room is available within the containment areas.
"Even if there is appropriate airflow from the office to the suite hallways, these configurations pose significant risk to laboratory personnel, since it is likely that contamination can easily occur and, in fact, was documented in B303."
2) Safety procedures at the Division and individual laboratory level are inadequately documented.
Completion of Minimal Essential Training is required for entry into the BSL-3 laboratories, but there is a paucity of written safety procedures at the laboratory or division level.
There is no formal Institute review process for specific laboratory procedures.
Individuals are primarily trained one-on-one until they are deemed to be adequately trained, but training materials at the laboratory level may not address safety issues. A sample procedure for spore preparation, one of the most dangerous procedures, did not specifically address safety issues.
3) Adherence to Institute safety procedures by laboratory personnel is lax
Direct questioning, results of surveillance cultures and an inspection of the BSL-3 laboratories indicates a number of deviations from Institute safety procedures.
Passboxes are to be used for single sheets of paper and items that have never left the office area. As noted by several personnel, stacks of paper, rather than individual sheets, are often placed in the passbox.
When multiple sheets are placed in the passbox, UV irradiation would be unlikely to be effective in decontaminating them and would be totally ineffective in decontaminating stacks of paper.
The passbox is also routinely used to pass live spore preparations out of the laboratory. This practice, while probably acceptable, violates the putatively uncontaminated office space in the B-3 suite.
In the course of the inspection of the BSL-3 suites on May 3, using the Institute quarterly inspection checklist as a guide, a number of deficiencies were noted. There was a substantial crowding due to storage of equipment.
There were numerous instances of unlabeled or improperly labeled chemical bottles, inappropriate storage of chemicals, benchtop clutter, collections of dirt and debris on the floor, supplies and equipment left in cluttered biosafety cabinets, and improperly handled biohazard waste both within and outside BSCs.
It is likely that the deficient housekeeping practices account for the areas of high-level contamination noted on the suite survey performed by .
4) Safety supervision is sometimes carried out by junior personnel with inadequate training or survey instruments, leading to weak enforcement of procedures.
The B-3 suite supervisor prior to noted that there was no clear line of authority for the suite supervisor. As a junior officer, he felt powerless to influence behavior of the laboratory investigators. Similar frustrations of inadequate authority or communication were voiced by in Building 1412.
These data indicate that safety inspections are not likely to be effective unless performed by individuals with adequate training and seniority to evaluate deficiencies and require corrective measures.
Moreover, there appears to be lack of communication between the Bacteriology Division Safety representative in Building 1425 and the Safety Office.
5) Outside review of Institute procedures may have been limited because potential exposures have not been adequately reported to the Army Safety Office and MRMC [U.S. Army Medical Research and Materiel Command] Safety Office.
USAMRIID reports exposures of individuals who are believed by medical personnel to have moderate to high risk of disease. While the language of [Department of the Army regulation] AR 385-50 Chapter 12-1 c. (2) is syntactically garbled, at appears that the ultraconservative interpretation of the regulation used by USAMRIID has nearly vitiated the regulation's intent. As a result, some exposures have not been reported and others were not reported as quickly as required by the regulation.
Similarly, the potential exposure incident that occurred on April 8, 2002, was not reported until April 23. The MRMC Safety Officer had no reports of potential exposures filed from USAMRIID in 2001.
The MRMC Safety Office did not physically inspect USAMRIID BSL-3 laboratories in 2001. It is likely that increased reporting would have triggered increased security of laboratory safety and increased compliance.
C.
1) USAMRIID personnel responded comprehensively and effectively to protect personnel when contamination was confirmed.
As noted by the timeline above, [USAMRIID officials] acted decisively to inform the community and Command, solicit assistance from CHPPM [U.S. Army Center for Health Promotion and Preventive Medicine], organize a thorough surveillance program, evaluate and reassure workers and continue to reexamine sites of positive cultures until decontamination was complete.
2) Confirmation of contamination might have been made two days before it was accomplished. This delay is explained by uncertainties in the manner of containment discovery and the low number of colonies identified. No adverse consequences occurred from this delay.
Detection of suspicious colonies by an experienced investigator greatly increased the likelihood that subsequent tests would be confirmatory of anthrax contamination. Immediate analysis of suspicious colonies by PCR would have probably confirmed the investigator' suspicions on April 16.
Given the unusual circumstances of the unauthorized sampling by Dr. Ivins and the low number of spores in the office area, initial caution in accepting the validity of the results may have been warranted to avoid premature panicking of the workforce and community.
3) A larger area of the building should have been cordoned off when contamination was reasonably confirmed. No adverse consequences resulted from this delay.
In the absence of an identifiable source of contamination, a more conservative approach would have required cordoning off at least all the laboratory areas until more definitive results were obtained.
Decision-making would have been easier if a contingency places had been in place.
4) MRMC and OTSG [Office of the Surgeon General] were notified promptly when contamination was confirmed.
MRMC and OTSG were notified of the potential contamination incident on April 19. Although AR 385-40 requires notification of the Army Safety Office within three hours of confirmed and potential exposures, that office was not notified until April 23.
D.
1) While a single source of contamination cannot be unambiguously identified, it is likely that some or all of the contamination occurred as a consequence of the outside of shipping containers brought out of suite B-3 in Building 1425.
The presence of multiple contaminants in both room 19 and B301 suggest that multiple episodes of contamination may have occurred.
It is most likely that some or all of the contaminants occurred when strains were removed from suite B-3 for shipment or transfer within the Institute.
A review of documents indicated Vollum 1 B was transferred on at least seven occasions in May 1997. The two most recent transfers occurred on June 1, 2000, and August 17, 2000.
Ames strains were shipped three times during that period, the latest two shipments occurring on May 8, 2001, and June 8, 2001.
stated that he placed anthrax spores in a tube inside the shipping container, and then wiped the container with a paper towel soaked with bleach. The bleach solution may have lost potency with prolonged storage and failed to adequately decontaminate the bottom of the shipping container.
said that after passing the shipping container through the passbox, he would sometimes leave it on his desk in an ice bucket or dry ice while awaiting shipping. It is possible that the outside of the shipping container may have been contaminated, and bacteria could have been transferred from the outside of the container to the desktop.
Another plausible explanation is that contaminated documents from the laboratory may not have been adequately sterilized by UV. irradiation and may have contaminated the desk area.
2) It is possible that opening of evidentiary material (a letter containing powdered anthrax) in suite B-3 created conditions leading to contamination of the outside of Ziplocs used to transport material out of the B-3 passbox and led to contamination of areas near the passbox.
Report of Investigation recommendations
1) USAMRIID should update the Institute biosafety manual
2) Reporting procedures for biological mishaps should be modified to conform with AR385-40. At a minimum, any potential exposure that results in a decision to consult a physician for consideration of antimicrobial prophylaxis or other treatment should be reported.
3) Office space and break rooms inside BSL-3 containment areas in buildings 1412 and 1425 should be treated as BSL-3 areas. Storage and consumption of food and drink should be prohibited in these areas.
4) Specific, written procedures that include detailed precautionary measures should be prepared for each laboratory procedure that uses viable agents.
Procedures should be reviewed by the biosafety committee for compliance with applicable regulations and updated regularly.
Particular attention should be paid to high-risk procedures, including centrifugation and shaker flask culture of etiologic agents.
Provision for regular surveillance cultures within BSL-3 suites should be included.
5) New personnel should be required to read and sign applicable written laboratory procedures before they are permitted to work in BSL-3 or higher laboratories. The suite supervisor should verify laboratory-specific training and submit a memorandum to the Safety Office granting entry to the suite.
6) Current laboratory personnel should be retrained using the written procedures. Retraining should be accomplished for all laboratory personnel at least annually.
7) Senior personnel should be assigned as suite supervisors and conduct monthly inspections using a detailed list IAW [in accordance with] AR385-69. Personnel evaluations should reflect safety performance.
8) Junior personnel in the Safety Office should receive additional hands-on training in equipment and procedures and participate in review of laboratory protocols to enhance their ability to perform inspections.
9) Walk-through inspections of all laboratory areas, including the BSL-3 suites, should be performed at least annually by knowledgeable safety inspectors from outside the Institute. The first inspection should occur within three months.
10) A comprehensive policy should be developed that
a) implements and defines regularly scheduled environmental sampling outside containment areas
b) establishes procedures for sampling if contamination is suspected between scheduled surveys, and
c) establishes procedures to protect personnel, identify the source of contamination and clean up if contamination is found.
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