Re- Trip report, Epi-Aid 2004-20: An investigation of a dual infection with E. coli O157:H7 and Salmonella serotype Cholerasuis var. Kunzendorf in a research laboratory worker. Authors: A. DuBois, N. Strockbine, & D.C. Jones (CDC), L. Edwards (MDHMH)

We have obtained a copy of the above-referred report from the CDC Freedom of Information Office.  As the individuals respectively identified as Patient A and her spouse in the report, we were interviewed as primary witnesses in the course of the accident.  We are writing this letter and the attached rebuttal document however, not only as witnesses of the accident but also as expert infectious disease microbiologists.  Patient A has been working with dangerous pathogens since 1984.  She holds a PhD in Microbiology & Immunology from Stanford University (1992), was on the Faculty at the London School of Hygiene & Tropical Medicine and the University of Maryland before she was hired by the ARS, USDA.  Her achievements in research in infectious disease microbiology include 22 peer reviewed publications and the award of several research grants, in the UK and US. She most recently was Principal Investigator of a $1.9 million funded research grant from the National Institute of Health.  Patient A’s spouse is currently Associate Professor and Director of the Infectious Diseases & Immunology Track of the Department of Biomedical Sciences at the University of Maryland, Baltimore.  Cumulatively, this represents over 40 years of experience in research and/or teaching infectious disease microbiology at institutions including UC Berkeley and UC San Francisco (spouse), Stanford U, U of Rochester, Institut Pasteur, the London School of Hygiene & Tropical Medicine, and U of Maryland (Patient A & spouse).  We have also consulted with a leading expert on the pathogenesis of E. coli O157:H7, Dr. James B. Kaper, Professor of Microbiology and Immunology at the University of Maryland, Baltimore. Professor Kaper is editor of the preeminent book on the topic and Chair of the International Steering Committee for the preeminent international symposium series on this organism.  We henceforth wish to indicate that the report contains major inaccuracies that are inconsistent with the information we provided during interviews. The occurrence of many of these errors is inexplicable as they involve data that should be available upon examination of the administrative and medical records. The report also contains pervasive evidence of poor investigative method and apparent disingenuous, biased or unfounded information provided to the investigators by staff at Facility X.  As a result, the investigators have reached erroneous conclusions and, critically, have failed to identify the major safety problems at the Facility.  The likelihood that accidents will continue to happen, as suggested by the unrelated recent E. coli O157:H7 infection of Patient C, is therefore a major concern.

The most egregious error of this report is that the supervisor of Technician X, who conducted the actual experiments that resulted in this laboratory-acquired infection, is incorrectly identified. The report identifies Patient A as the ‘official supervisor’ of Technician X on the day of the accident. This is a complete falsehood. Patient A was never the official supervisor of Technician X. In fact, another scientist at the Facility, who is not mentioned or alluded to in the report (referred to as Researcher C in the attached rebuttal document) was Technician X’s official supervisor in December 2003. As such, Researcher C was responsible for the design, conduct and supervision of the E. coli O157:H7 experiment, not Patient A.  The report further concludes that Patient A’s laboratory technique is in large part responsible for the accident. This assessment is based on poor investigative method, whose results are wholly unreliable. We hereby vehemently contest these elements of the report and request that the record be appropriately and publicly corrected. We have itemized the report’s numerous inaccuracies, omissions and evidence of flawed investigation in the enclosed point-by-point rebuttal document.

In summary, the information we provide in rebuttal indicates that:

• Patient A was not supervising Technician X in any capacity during the period of December 3-9, 2003,
• Patient A was not in any way responsible for the design or conduct of the E. coli O157:H7-salad spinner experiments performed by Technician X,
• Patient A was not using or working with E. coli O157:H7 for her own experiments at any time.

The information provided further establishes that they were serious flaws in the method or interpretation of data by the investigative team including:

• Multiple errors of data accuracy, many of which are of critical importance to interpretation, such as culture results, dates, experimental conditions, etc,
• Survey of an uncontrolled, partial and/or uninformed population of coworkers on Patient A laboratory techniques,
• Fatal flaws in the re-enacted E. coli O157:H7 salad spinner experiment,
• Misinterpretation and absence of verification of comments made by Patient A.

Finally, the information in the attached rebuttal document strongly supports that:

• the most likely route of infection by E. coli O157:H7 is through direct contact of contaminated surfaces or inhalation of an aerosol originating from the experiment performed by Technician X on December 5, 2003,

·         Major factors contributing to the accident are the suboptimal safety conditions inherent to the design of the salad spinner experiment,

·         A secondary factor in the accident is the lack of relevant competence in infectious disease microbiology of the Research Leader.

We believe that the many mistakes of the report have led its authors to the wrong conclusions. In as much as this report is part of the public record and as it directly attacks the professional qualities of one of us and the integrity of both, we request that measures be undertaken to fully and comprehensively correct the report.  We also note that since the research facility is identified by name once in the report, patient confidentiality has essentially been lost.  This inexplicable lapse, while further illustrating the poor quality of the report, underscores the necessity that the correction we request becomes part of the public record.

Since this investigation is ultimately critical, not only to the safety of current and future researchers at the Facility, but also to public health, we are confident that you will agree that nothing less than a full and accurate account of the events surrounding the laboratory accident that nearly took the life of Patient A is necessary. Indeed the April 16, 2004, accident involving Patient C, likely another laboratory-acquired E. coli O157:H7 infection, would suggest that unsafe practices continue at the Facility long after the departure of Patient A.