February 6th, 2014 8:43 am ET - Ali S. Khan
CDC is responsible for protecting the public from a host of health threats, including some pretty scary pathogens, like Ebola virus or anthrax for example. One way we do this is through our Select Agents Program which is responsible for governing and regulating the use of certain pathogens by research facilities and labs around the world. In the beginning of December I had the remarkable opportunity to accompany the inspection team who helps regulate the Select Agents Program on one of their routine lab inspections. I was invited to an inspection of a laboratory in the Southeast region of the U.S. that handles rare and dangerous pathogens to get a glimpse of how the Inspection team operates, what they look for, and what they do to protect us.
Laboratory inspections are an important aspect of the Select Agents Program since they ensure that labs and research facilities are complying with guidelines and regulations specific to biological research. In order to improve our understanding of human health and disease, some laboratories handle rare and potentially dangerous biologic agents and toxins, which are known to cause severe infection, illness, and sometimes death in humans. Laboratories that possess and use these types of biologic agents and toxins for manufacturing purposes, research use, or diagnostics must be registered through this program. When they register with the program, they agree to follow all requirements in the regulation (42 CFR Part 73 – Possession, Use and Transfer of Select Agents and Toxins) including, safety, incident response, security, and having appropriate training in place. CDC’s job is to ensure that all precautions are being taken at laboratories so that the public remain unexposed and unharmed by these potential health threats.
The inspection that I joined actually began one week prior to the inspection date when I met with the Inspection Team to prepare a folder with all of the Southeast facility’s biosafety plans, incidence response plans, and security plans. The following week, I flew to the site to meet with the inspection team. I was set to be with the team for the first and most active day of their inspection.
The inspection started with introductions and a briefing among the group. Then there was a visitor’s training to instruct all personnel of potential hazards as well as actions to take in the event of an emergency. To avoid workplace injuries and hazards, personnel must meet all occupational health qualifications. In this laboratory, personnel must perform an exercise test to confirm adequate fitness to wear a respirator. There are two types of respirators at this facility, one that is simply a facemask and another that is a full-body suit. The team thought that I would opt for the full body respirator because it did not require that I shave my beard. However, I gladly accepted the challenge to dawn the facemask respirator (and shave my beard!) to earn my place as member of the team.
Suited up in gowns, gloves, shoe covers, masks and other inspector accessories, we were ready to begin our inspection. Our goal was to go through all of their laboratory space to check that the facility was adhering to appropriate biosafety measures. We checked biological safety cabinets and animal cages, catalogued inventory, and performed other tasks associated with laboratory compliance. Lab personnel graciously halted their work during our visit
The devoted team sought to conduct as much of the laboratory-based inspection as possible the first day. We were successful. After seven hours of tireless work and a brief stint for lunch, we had canvassed the entire facility. The personnel at the Southeast facility were pleasant, welcoming, and grateful for the visit, remarking that they looked forward to an external perspective. Having thoroughly inspected the lab, we finally retired for the day.
A Days Work is Never Done
Though I remained for only the first day, the team continued diligently throughout the week. They reviewed all of the Southeast facility’s documents, checked its security, and evaluated its waste, storage, and laboratory maintenance procedures. The team is then responsible for generating a report that lists observations that deviate from regulatory requirements. After much collaboration between the Select Agents Program and the Southeast facility, the Southeast facility is expected to implement changes to receive standard renewal.
I was incredibly impressed with the Select Agents Program’s laboratory inspection. I know that because of them, we can rest assured that high containment facilities operate at the toughest standards. Thanks to this program, the biosafety measures in place consistently enhance the safety and security that the CDC promises to uphold to the American people.