NBACC strives for a zero accident workplace with an emphasis on prevention of potential problems. The central theme is continuous improvement. Monitoring quality, near misses, and events provides opportunities to analyze small things for areas where processes and procedures can be improved in order to prevent big things from happening. NBACC manages risk using multiple, redundant, or duplicate, approaches. For each of the risk scenarios below, NBACC has in place combinations of physical (e.g., air filters, gloves, vaccines), process (e.g., rules, regulations, inspections, standard operating procedures, background investigations, work reviews and approvals), and personnel (e.g., training, oversight, performance reviews) controls to manage risks to employees and the community.
How does NBACC protect employees and the community from environmental release?
For every BSL-3 and 4 laboratory that works with biological agents and toxins, a containment boundary has been established to prevent the release of contamination. Anything that will leave the laboratories and cross this boundary is required to undergo a validated and verified decontamination process. All of the air that leaves the laboratories is filtered through high efficiency filters that are tested and certified to be effective. These filters are continually monitored for potential problems and are re-certified every year. Similarly, all of the liquids that cross the containment boundary are heat treated (i.e., pressure cooked) before leaving the facility. The pressure cookers have been validated to be effective in sterilizing liquid and are re-checked annually. In addition to the heat treatment, if a liquid is suspected of coming into contact with a biological contaminant, it is also chemically inactivated (e.g., mixed with bleach) before being sent for heat treatment.
All of the trash that is generated inside the laboratories is collected and heat treated using an autoclave. The autoclaves use a tested combination of steam heat and pressure to sterilize the waste. The autoclaves undergo routine testing to ensure proper operation. A special heat sensitive tape (i.e., autoclave tape), that changes color at high temperature, is applied to every waste bag to serve as a visual indicator that the waste was properly sterilized. Equipment or tools that need to be removed from the laboratories are chemically decontaminated using a powerful gaseous oxidizing agent (e.g., concentrated hydrogen peroxide). Biological Indicator strips are used for every decontamination cycle to ensure that the hydrogen peroxide reached every area with sufficient potency to kill biological agents.
Staff members are never allowed to bring any personal items (with the exception of prescription eye glasses) into the laboratories. Whenever they need to enter a laboratory, all jewelry is removed, and then staff change into laboratory scrubs. When leaving the laboratory and before crossing the containment boundary, staff members remove the laboratory scrubs and take a full shower. If prescription eye glasses were worn, they would be scrubbed clean during the shower. All of the shower water is collected and heat treated in the pressure cookers. The laboratory scrubs are collected and heat treated in an autoclave before going to laundry.
Each of the systems used in maintaining the laboratory containment boundary undergoes a thorough preventative maintenance process to help ensure continual operation. Redundant systems are in place so that in the event of a system failure, there is a back up in place ready to protect the containment boundary. The coordination between the primary and redundant systems is tested every year by running simulated failure scenarios and verifying that the redundant system works as designed.
Every staff member at NBACC receives extensive training in all aspects of their job responsibilities. Prior to being allowed to access a laboratory space, training is provided on safe operations, recognition of hazards associated with the material they will be working with, and how to respond in the event of an emergency. Initial access to a laboratory space is granted through a mentorship program where a staff member is paired with an experienced laboratory worker who is responsible for teaching safe laboratory practices. A staff member is not allowed to enter a laboratory by themselves until after they demonstrate to their mentor that they have the knowledge and skills to work safely. In addition to all of the initial training required to enter a laboratory space, every staff member must complete annual refresher training in order to maintain their access.
What does NBACC do to manage the risk from insider threats?
Insider threat mitigation starts even before a new employee is hired. Screening is conducted before an employee becomes part of the NBACC workforce, and includes reference checks, verification of prior employment and education, criminal records checks, Social Security number confirmation, financial review, proof of citizenship, and drug testing. Extensive suitability screening is also independently performed by DHS. Once hired, all NBACC staff members must obtain and retain a Security Clearance. In addition, new laboratory staff must have an additional background check performed by the FBI’s Criminal Justice Investigation Service (CJIS). The FBI uses a finger print check to ensure proper identity and then checks the staff member against twelve criteria that could potentially disqualify them from being granted access to select agents and toxins.
Repeated studies have determined that the best way to mitigate, or reduce, the risk from insider threats is to create an open reporting culture, where employees feel comfortable raising concerns without the fear of retaliation. NBACC uses a combination of pre- and post-employment screening, training, and personnel management approaches to establish and maintain an individual and institutional culture of responsibility. This approach incorporates the best practices recommended by the National Science Advisory Board for Biosecurity.
NBACC also has a robust Personnel Reliability Program which uses both peer- and self- reporting in a variety of situations ranging from seemingly harmless issues like a speeding ticket or use of over-the-counter medications that cause drowsiness, to more complex issues that might include depression, surgeries, family issues, financial problems, and legal problems. Staff members are required to actively engage in the reporting process as a condition for being granted access to the laboratories. Staff members are trained to be aware of changes to their everyday surroundings and peer behaviors, and to report anything that seems abnormal. Extensive annual security training also reinforces staff vigilance regarding operational security, computer fraud, foreign intelligence service recruiting tactics, and daily situational awareness. The combination of these individual efforts results in a strong culture of insider threat awareness and prevention at NBACC.
How does NBACC protect the community from risks associated with occupational exposure (i.e., an infected employee going out into the community)?
Employee health and medical surveillance is a key part of reducing the risks for NBACC staff as well as protecting the community. NBACC has a comprehensive Occupational Health and Medical Surveillance program. Annually required health screenings that include physical exams, history, urinalysis, and blood work allow medical professionals to develop a medical baseline for each staff member and assess fitness for duty, immunocompetence, as well as distinguish changes from year to year, and provide a complete picture of each lab worker’s health. All staff members are required to immediately report certain symptoms of illness to the Competent Medical Authority (CMA) who has a high index of suspicion for the biological agents with which the BNBI staff work. This rigorous reporting requirement allows the medical staff to identify any early symptoms of an unrecognized exposure and separate that from a normal illness in the population.
Every event that occurs inside a laboratory is analyzed by both the NBACC Health and Safety Department and the CMA to determine if there is an increased risk of exposure. If this evaluation determines that there is an increase in risk, the CMA will make a determination as to any required follow on actions. This might include placing the employee on a fever watch with increased reporting requirements or starting preventative treatment. In the very rare case of a high risk of exposure, it will be determined whether this person can be treated on site, if they need to be admitted to a clinical setting for treatment, and whether notification is needed to local public health officials. Agreements are in place for admission of a staff member for both the local hospital (immediate care for acute injuries) and the Special Clinical Studies Unit (SCSU) in Bethesda, MD, which is specially configured for the treatment of infectious diseases. Once a staff member is able to return to work, he/she must meet with the CMA and be medically cleared for work in the laboratory before their access can be restored.