Our Insights

An Interview with Biosafety Expert, Betsy Gilman Duane

In April 2012 a laboratory worker at the San Francisco Veterans Affairs Medical Center died from an infection with Neisseria meningitidis, serogroup B, a vaccine-resistant strain.  Recently, the U.S. Department of Labor’s Occupational Safety and Health Administration (OSHA) concluded its investigation and issued a notice of unsafe and unhealthful working conditions to the medical center. The notice consists of three serious violations for failing to protect laboratory workers researching Neisseria meningitides, including failure to:

• Require workers to use a safety enclosure when performing microbiological work with a viable bacteria culture.
• Provide training on the signs and symptoms of illnesses as a result of employee exposure to a viable bacteria culture.
• Provide available vaccines for workers potentially exposed to bacteria.

In this interview, Betsy Gilman Duane MS, RBP, CBSP, offers insight as to the potential risks involved in working with bacterium such as Neisseria meningitides and the lessons that can be learned from this tragedy.

Q. What are the risk factors when working with Neisseria meningitidis, serogroup B?

There is currently no licensed vaccine to protect against this particular serogroup of N. meningitidis.  When a risk assessment is performed for a project with this particular serogroup, that information needs to be included.  Use of engineering controls such as a biosafety cabinet and personal protective equipment become very important in the overall risk reduction strategy.  We know that for Neisseria meningitidis the routes of exposure include injection, ingestion and exposure to mucous membranes to infectious droplet nuclei or aerosols.  With that in mind, standard operating procedures (SOPs) need to be developed to protect against these routes of exposure.  It’s a risk group two (RG2) agent, but in this case enhancing the work practices and protective equipment may be justified.  In this situation it would be prudent to utilize enhanced biosafety level two practices. For example, two enhancements that make sense include wearing a disposable gown instead of a cotton lab coat, and performing all manipulations inside the biosafety cabinet instead of on the open bench.  Perhaps the decision is made to conduct this work exclusively in a separate laboratory room to limit access to only those who work with the bacteria.  These enhancements then become part of the information that is conveyed during training.

Q.  What is the severity of the OSHA citations and are monetary fines associated with these citations?

Typically this type of OSHA citation does carry a monetary fine, the severity of which depends upon the number and nature of the violations, not to mention other negative attributes such as negative publicity for the institution or loss of grant money for the Principal Investigator (PI).  However, in this case the U.S. Department of Veterans Affairs is a federal agency, and one federal agency cannot impose monetary fines against another federal agency. OSHA fines are typically the “tip of the iceberg” when it comes to a serious workplace injury or death. The impact to the institution’s safety profile is impacted significantly, both internally and in the mind of the community.

Q.  Two of the citations involve failure to conduct work within a safety enclosure and lack of personnel training.  In your experience, are these common issues in laboratories?

Unfortunately, yes. It is fairly common for laboratory workers to not fully understand and appreciate the potential for aerosolization of infectious media using common laboratory manipulations and procedures and the protection that a biosafety cabinet affords in controlling those exposures.  For example, when used correctly, the cabinet provides protection for the worker, the laboratory environment and other personnel in the work area, and for the materials being manipulated in the cabinet such as bacterial cultures.

Personnel training should go beyond the general awareness biosafety training that is provided to laboratory workers by a biosafety officer or other EH&S professional.  The PI of the laboratory needs to ensure that his/her laboratory personnel are adequately trained on the safe techniques for working with microorganisms in the laboratory.  This includes providing information on the signs and symptoms of infection, and the importance of reporting illness promptly to the PI and the institution’s Occupational Health service.

Q.  One citation involved the failure to provide available vaccines for workers potentially exposed to bacteria.  This case specifically involvedNeisseria meningitidis, for which there currently is no vaccine.  How was OSHA able to enforce this in this instance?

This is an interesting citation and we may eventually hear more about this.  There is a vaccine for other strains of N. meningitidis, and perhaps these other strains were also in use in the laboratory. Although OSHA does not have a specific health standard for N. meningitidis, it can enforce exposure controls, such as vaccinations, under the General Duty Clause of the OSHA Act of 1970. The bottom line is that an institution must have a policy for vaccines that protect against microorganisms in use in the laboratory.  The policy also needs to be communicated to PIs and their respective laboratory personnel.  Through the risk assessment, the need for a vaccination is established. As OSHA indicated with this citation, the bottom line is that the policy must provide for the vaccine and make it available free of charge to workers.  This is very similar to OSHA’s requirement in the Bloodborne Pathogen Standard for Hepatitis B vaccine to be offered free of charge to those who have the potential for occupational exposure to human materials.

Q.  What lessons can be learned from this incident that would help institutions ensure the safety of their lab workers?

First, institutions must require that PIs establish and maintain a safety culture in their respective laboratories.  This includes the training mentioned previously, and taking an active role in oversight of laboratory activities and safety in the laboratory.  This doesn’t mean that some of this responsibility can’t be delegated to a laboratory manager or other designee, as long as the PI maintains an active role in the oversight.  In addition, the risk assessment must be conducted and factor in any available vaccines or lack thereof.  From there the appropriate risk reduction strategies can be developed, communicated and put in place.  Finally, institutions need to establish vaccination policies for work with microorganisms where there are effective vaccines available.

Betsy is Biosafety / Laboratory Safety Service Leader at EH&E.  She has over 25 years experience in the laboratory safety and biosafety fields. For more information, contact Betsy at bgduane@eheinc.com.