Three high-profile separate incidents involving anthrax, avian influenza, and Ebola occurred in 2014, prompting officials with the Centers for Disease Control and Prevention to take a closer look at laboratory safety.
During a recently-held CDC Grand Rounds series, Stephan Monroe, PhD, Associate Director for Laboratory Science and Safety at the CDC discussed some of these incidents. He was joined by Conrad P. Quinn, PhD, Chief of the Meningitis and Vaccine Preventable Diseases Branch at the National Center for Immunization and Respiratory Diseases and Associate Vice President of the Research Safety and Professor of Microbiology at University of Chicago Joseph Kanabrocki, PhD who gave separate, sequential talks on the subject of laboratory safety during the Grand Rounds session.
Dr Monroe began by reviewing the incident involving anthrax, which involved improper inactivation of live bacterial spores. This incident prompted CDC officials review inactivation procedures of Biosafety Levels 3 and 4 pathogens.
The second incident involved cross contamination between avian influenza viruses, which prompted CDC officials to require time and space separation of work and use quality testing for everything shipped from high containment labs.
In the most recent incident, misidentification of two samples from the same experiment with one live and one inactivated Ebola virus prompted officials with the CDC to institute color coded identifiers to make it easier to differentiate between live and inactivated samples.
Dr Monroe noted that since these incidents, an external advisory committee of safety officials have visited laboratories, spoken with staff, and reviewed safety procedures. The agency has issued 2 reports to address gaps in staff training, completion of risk assessments, consistency of lab accreditation and guidance on incident notification. Dr Monroe said his leadership has been established for sole accountability for these processes, and he noted that CDC labs have a chance to progress in terms of safety and quality.
Lab Safety in Action
Following Dr Monroe’s talk, Dr Quinn presented: “Quality, Safety and Public Health Impact of Lab Science: A Case Study,” where he used a single CDC laboratory to illustrate the importance of safety and quality.
A team of scientists in the Microbial Pathogenesis and Immune Response Laboratory (MPIR) led a clinical trial for the U.S. licensed anthrax vaccine in 2001 to support a comprehensive research program on safety and immunogenicity called the Anthrax Research Vaccine Program (AVRP), which was established in the late 1990s after a request from Congress.
The CDC was tasked with finding a different route of administration for the anthrax vaccine, in addition to establishing immune correlates of protection and optimizing the primary series in booster schedule, according to Dr Quinn. To successfully complete this task, the lab had to have “rigorous quality and safety controls in place” for success, and built its own umbrella quality assurance program to meet AVRP requirements, Dr Quinn explained.
The lab standards drew heavily on relevant components of International Standards of Organization’s 8 quality principles of the ISO 9000 management practices system, the Good Laboratory Practices and Clinical Laboratory Improvement Amendments (CLIA) to make sure anthrax serology was compliant for supportive clinical trials, clinical case confirmation and patient management according to Dr Quinn.
Dr Quinn noted that quality and safety are tightly linked. Immune response assays were validated to International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, specific study processes and procedures managed and monitored in a quality management system.
Dr Quinn noted that it has been very helpful during this process to have researchers divided into teams for specific skill sets. A quality management system (QMS) is needed to record and monitor processes and procedures as well as to monitor team member qualifications and proficiency.
Dr Quinn noted that safety, incident management and continuous improvement are important, and that a “safe and quality lab is a leadership exercise,” where staff are provided with a framework and resources. Dr Quinn noted the importance of setting clear objectives using the SMART objectives approach.
Dr Quinn concluded that using existing models and technologies, systems for data processing, specimen and data management, CDC info technology and adopting best practices from other institutes and agencies are all keys to lab safety.
Implementing Safe Laboratory Practices
During the last of the Grand Rounds sessions, Associate Vice President of the Research Safety and Professor of Microbiology at University of Chicago Joseph Kanabrocki, PhD, CBSP spoke about “Establishing a Culture of Safety in an Academic Research Institution: Teaching Safety to Scientists.”
To encourage a culture of safety in the laboratory, it is essential to have “institutional infrastructure, oversight, and knowledge, awareness, and communication,” Dr Kanabrocki said.
Strong leadership is key at all levels through the top structure, and training needs need to be developed and tracked for efficiency to train future leaders, Dr Kanabrocki explained, adding that it is important that leaders have scientific training and understand the language of laboratory scientists. Lab professionals also need to be supported in their safety and training by the institutions where they perform their work.
Next, Dr Kanabrocki said that good institutional infrastructure and oversight are also required, including “institutional controls to assess and monitor risk, improve biosafety procedures, and encourage incident reporting.” He commented that incident reporting should be highly encouraged without repercussions, and there should be multiple paths to reporting when an incident occurs in the lab.
Knowledge, awareness, and communication can be achieved by engaging the broader community and using multiple forms of media to increase awareness about lab safety, Dr Kanabrocki concluded.
1. Centers for Disease Control and Prevention Public Health Grand Rounds. Strengthening a culture of laboratory safety [webinar].December 15, 2015. http://www.cdc.gov/cdcgrandrounds/. Accessed December 15, 2015.