Biosafety Practices Have Come Under Fire: What Have We Learned?
An interview with Betsy Gilman Duane, MS, RBP, CBSP
Incidents involving anthrax and the H5N1 influenza virus in federal laboratories and the threat of the Ebola virus in the US created a media storm and put intense pressure on the biosafety community to strengthen and improve practices in 2014. This past summer the biomedical research community was concerned about reports of a potential 24-hour “stand-down” but in late August the National Institutes of Health (NIH) announced a new initiative, National Biosafety Stewardship Month. The purpose of this initiative is to strengthen biosafety practice and oversight in the research community.
Looking back on these numerous high profile events of 2014, what are the lessons learned? In this interview Betsy Gilman Duane, MS, RBP, CBSP, discusses what this year’s events mean for the biosafety community, the lessons learned, and what institutions should plan to do in 2015 with regard to strengthening biosafety programs.
Q. There were two incidents that occurred at the CDC. In the first, a sample of a low-virulence flu virus that was transferred to another laboratory had been accidentally contaminated with the H5N1 avian flu strain. The second incident involved the transfer of potentially inadequately inactivated anthrax bacteria from a biosafety-level-3 laboratory to a lab with a lower safety level that was not equipped to handle this pathogen. What measures should institutions have in place to ensure that these types of safety issues do not occur within their labs?
A. These events highlighted the importance of having robust biosafety procedures in place. When followed correctly by trained personnel, these procedures will ensure the safety of laboratory workers as well as the environment and the public. This is definitely a team effort between the laboratory workers and leadership, the biosafety professionals and the Biosafety Committee (BC) or Institutional Biosafety Committee (IBC). For BSL-3 labs, for example, it means reviewing procedures for inactivating materials so that they can be removed safely to lower containment. Do the procedures work 100% of the time if followed correctly? Are there controls in place to verify the inactivation procedures and to ensure that they are followed correctly? And most importantly, does senior leadership promote a strong biosafety culture such that laboratory workers are encouraged to speak up if there are safety concerns in the laboratory? The events that occurred at the CDC are a critical reminder to institutions to have a biosafety management system in place. The concept of “plan, do, check, act” that is part of an effective safety management system is something that all institutions working with biological agents and toxins should include in their respective biosafety programs.
Q. One concern that has been raised by the public and some regulatory agencies is that if these severe lapses in safety practices can happen in federal labs, it could happen anywhere. How do institutions restore public faith in the biomedical community?
A. Institutions should be transparent and continuously look for ways to improve their respective biosafety programs and Biosafety or Institutional Biosafety Committees. The public and the regulators expect that research with biological agents and toxins will be thoroughly reviewed and that only those projects that can be done safely by properly trained and supervised personnel will be approved and conducted. Regardless of whether an institution is subject to the NIH Guidelines (Guidelines for Research Involving Recombinant and Synthetic Nucleic Acid Molecules), it should strive for a process where meeting minutes from the IBC, or equivalent, detail the discussions that transpire during the meeting, show how the containment level was arrived at, and highlight relevant biosafety issues and whether they are adequately addressed prior to approving a protocol. These processes should then be communicated with the public as much as possible. This can be accomplished by placing meeting minutes on their website, and working with their public affairs department to include biosafety information relevant to scientists and their respective projects when they are featured in communication pieces. For example, an online piece about a scientist who has recently been awarded a grant to study a virus could include a paragraph about how the Biosafety Committee – or Institutional Biosafety Committee if the project involves recombinant DNA – worked with the scientist to develop the safety procedures and laboratory facility required for the work to be done safely.
Q. The first confirmed case of the Ebola virus disease in the US brought questions about the use and availability of personal protective equipment, staff training, handling and disposal of contaminated materials. How can institutions adequately prepare for these types of unexpected emergencies?
A. On the healthcare side, we’ve seen a number of institutions scrambling to put together Ebola response plans, develop procedures such as donning and doffing personal protective equipment (PPE), train workers, and prepare for the possibility of an individual with Ebola virus disease. We’ve seen quite a few collaborations between biosafety professionals and healthcare professionals such as hospital infection control practitioners. Collectively they are working through many of the challenges. These events also underscore the need for response plans, not just for Ebola, to be reviewed on a frequent basis and improved upon as needed. For Ebola virus and other bloodborne disease agents, it’s important for healthcare institutions to review the Occupational Safety and Health Administration (OSHA) Bloodborne Pathogen Standard, perform a risk assessment, and put together the necessary program elements. Healthcare institutions may find it helpful to enlist a qualified expert to assist them in putting together effective response plans and training their personnel. This is particularly true in a situation such as Ebola preparedness, when time is critical in having response procedures in place and having trained personnel comfortable with those procedures. As for availability of PPE, namely protective garments, it’s interesting that we saw a similar problem in the late 1980’s and early 1990’s where there were shortages of disposable gloves. That was in response to concerns about bloodborne pathogens and compliance with the OSHA Bloodborne Pathogen Standard. Glove manufacturers stepped up production efforts to respond to the increased need for gloves as a result of this shortage, but it did take many months before adequate supplies were available. It appears that manufacturers of protective garments are now increasing their production capability, but it’s certainly an appropriate time for all organizations that utilize PPE to review their supply needs and plan in advance for any future shortages.
Q. NIH designated September as National Biosafety Stewardship Month and most institutions – even those not funded by NIH – participated. We know that highly functioning and effective biosafety programs require constant vigilance. What should institutions be doing throughout the year to ensure the effectiveness of their programs?
A. While NIH’s designation of National Biosafety Stewardship Month certainly helped to highlight the importance of the biosafety profession, it also identified a number of biosafety-program areas where the focus should be a continuous effort, rather than isolated to one month out of the year. The three critical areas that NIH requested that institutions review included biosafety policies and procedures, agent and toxin inventories, and biosafety training for lab personnel, principal investigators and IBCs. That’s quite a lot to focus on in a period of one month! For some institutions this could be a major undertaking depending on biosafety staffing levels. A best-practice strategy would be to take these biosafety program elements, prioritize them and put a schedule in place to address these elements during the course of the year. It’s really a continuous improvement process. A valuable exercise that institutions can undertake to evaluate the efficacy of their program is hiring an independent consultant to conduct an audit of their program. An independent audit will assist in identifying the program areas that could be improved or modified for compliance and/or efficiency. An experienced consultant can offer assistance with improving the program and assist with implementing the recommendations, as well as provide qualified biosafety professionals to assist the client on a temporary or permanent basis.
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 firstname.lastname@example.org or at 1-800-825-5343.