Linda Goossen, Ph.D., MT(ASCP)
Chair, ASCLS Government Affairs Committee
The recent international occurrences of Ebola and Zika viruses have reinvigorated the national interest in biosafety and biosecurity in medical and research laboratories. The term “biosecurity” has been used in different contexts and has acquired different meanings for people with different backgrounds. WHO and the American Biological Safety Association define “Biosecurity” as the protection of microbial agents from loss, theft, diversion or intentional misuse. Biosafety refers to the reduction of exposure of laboratory workers and facilities to potentially hazardous and infectious agents and protection from the diseases produced by these hazardous materials. One term deals with security and the other deals with safety.1 Biosafety and biosecurity programs share common components. Both are based upon risk assessment and management methodology; personnel expertise and responsibility; control and accountability for research materials including microorganisms and culture stocks; access control elements; material transfer documentation; training; emergency planning; and program management.” 2
At the April 14 meeting of the Clinical Laboratory Improvement Advisory Committee (CLIAC), Toby Merlin, MD (Director, Division of Preparedness and Emerging Infections, CDC) and Reynolds Salerno, Ph.D. (Division of Laboratory Systems, Center for Surveillance, Epidemiology and Laboratory Services, CDC) presented current biosafety challenges our laboratories face. These challenges include the fact that “changes in demographic, environmental, and cultural trends have made outbreaks of emerging and reemerging Infectious disease more common” and thus we can expect that laboratories will have to contend with more outbreaks of infectious disease in the future. As a result, we need to be able to provide better biosafety guidance and support to clinical laboratories. However, there is currently a lack of professionals with laboratory biosafety knowledge and experience, a factor resulting in delays in hiring Biological Safety Officers (BSO).
Evidence of the biosafety gaps in the U.S. can be found in the CDC Rapid Ebola Preparedness Team report from their assessment of U.S. readiness to treat Ebola patients
From October 2014 through January 2015, the CDC REP teams evaluated 55 hospitals for their ability and preparedness to receive, identify, and treat patients with suspected or confirmed Ebola virus infection.
As reported by Nancy Cornish, M.D. (Medical Officer, Division of Laboratory Systems, CSELS, CDC), the assessment showed that “laboratory staff were not always conducting risk assessments, following OSHA’s blood borne pathogens standards, or implementing safe work practices; laboratory instruments were not necessarily safe for operators; there was a lack of communication between the lab and clinicians; there was insufficient training in work practices and personal protective equipment (PPE) and a lack of data on safety of routine clinical laboratory procedures for Ebola specimens.” In addition, the team reported that some professional organizations recommended that laboratories limit testing in their regular clinical laboratories on Persons Under Investigation (PUI) for Ebola and some national reference laboratories requested that clients not submit specimens from PUIs for Ebola.
Furthermore, in 2013, researchers at UCLA published results of a survey of almost 2,400 scientists on attitudes about safety. Approximately half the respondents had experienced injuries in the lab and 30% had witnessed a major injury. Of the U.S. respondents, only 25% conduct formal risk assessments and 50% assessed risk only “informally.” The survey also revealed that safety standards are often not adhered to and “only 60% said they had received safety training on specific hazards or agents they worked with.” 3
The question remains of how we can ensure clinical laboratories are well prepared for emerging infectious diseases and biological threat. CLIA regulations 42 CFR Part 493.1407(e)(2) and 1445(e)(2)charge the laboratory director with ensuring that the physical plant and environmental conditions of the laboratory are appropriate for the testing performed and provide a safe environment in which employees are protected from physical, chemical, and biological hazards. Regulation 493.1101(d) states that safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. Thus, we need to ensure that laboratory directors are aware of their responsibilities for providing a safe environment for their employees. We are also responsible for proper education of our laboratorians to increase their knowledge, skills, and abilities to guarantee a safe working environment for all. Training and education of laboratory staff must begin early; including laboratory safety in the curriculum for undergraduate and graduate programs is essential. Education of laboratory staff must include PPE requirements and engineering controls available for use in the lab, including biosafety cabinets, splash shields, and closed instrumentation.
In her Keynote presentation at the ASCLS 2015 Annual meeting, Dr. Cornish asserted that risk assessment is the basis of a laboratory safety program. Risk assessment is a 5-step process of identifying the hazards (agents, procedures, and staff), evaluating the risks, determining controls, implementing controls, and evaluating the outcomes. The assessment should include pre-analytic, analytic, and post analytic processes. For the assurance of safety from biological agents, the assessment must include personal protective equipment (PPE), and determine if it is appropriate for the activity and if the staff has been trained and are comfortable with its use. Biosafety Cabinets must also be assessed to ensure they are being used and maintained properly.
The bad news for laboratories is that labs are very short staffed and working on biosafety issues is a low priority, leading to a lack of fundamental knowledge about biosafety in the lab community and weak biosafety culture. Most clinical labs have never performed a risk assessment. The good news is that multiple agencies are currently focused on developing programs and protocols to encourage a culture of biosafety and biosecurity in our nation’s laboratories.
For example, the American Public Health Laboratories “was awarded a $2.2 million cooperative agreement in the spring on 2015, with the CDC to assist public health laboratories strengthen biosafety and biosecurity practices and to develop guidance and tools to support public health laboratory outreach to sentinel clinical laboratories formed a biosafety and biosecurity committee”
The objectives of the committee include the following:
- outreach to public health laboratories to assist these labs with implementing the activities outlined in the CDC’s Epidemiology and Laboratory Capacity for Infectious Disease Cooperative Agreement,
- delivering training via workshops, webinars, and other modalities on packaging and shipping of infectious substances ad conducting risk assessments,
- creation of online forums to facilitate information sharing among biosafety professionals at public health laboratories,
- creation of a repository for new and existing biosafety and biosecurity tools and promoting their use,
- establishment of a Biosafety and Biosecurity that will develop biosafety and biosecurity guidance material, address policy issues, and design tools to support risk assessments in both public health and clinical facilities.
In April 2015, CLIAC recommended to the U.S. Department of Health and Human Services that the department provide oversight that ensures that biosafety training and assessment is required of all CLIA-certified laboratories, including personnel responsible for the pre- analytic, analytical, and post-analytic phases of testing; ensure oversight, input, and resources into studies evaluating the safety of all laboratory practices, instrument testing, so that studies are sound, robust, evidence-based and applicable; and develop a process for investigating and reporting laboratory acquired infections.
ASCLS has also made our voices heard regarding the nation’s biosafety and biosecurity preparedness. In comments addressed to CLIAC in 2015, we stated “While the latest infectious disease outbreak (Ebola) raised a number of questions about the occupational health and safety risks faced by everyone in healthcare, we should all be familiar with how to protect ourselves and our patients from biological hazards presented by exposure to infectious agents… OSHA standards and CDC guidelines when used, and used correctly, are very protective and effective. Admittedly complacency sets in and the risk assessment process that CDC is promoting is an excellent way to educate and re-educate laboratory professionals. We hope that CDC will partner with all professional organizations to disseminate credible education… We believe this is a great time for the clinical and public health laboratorians to work together to address our issues, and to implement a strong safety culture throughout all sectors.”
- Biorisk management Laboratory biosecurity guidance. World Health Organization. September 2006, WHO/CDS/EPR/2006.6
- Biosafety in Microbiological and Biomedical Laboratories, p 104. CDC.
- Richard Van Noorden, “Safety Survey Reveals Lab Risks,” Nature 493, pp9-10; 02 January 2013