CDC anthrax, avian flu lapses point to broader problems in lab safety
Hospitals must build a culture of lab safety
Hospitals often hear from the Centers for Disease Control and Prevention about the importance of building a culture of safety. But the agency’s own recent lapses in the laboratory have provided a lesson in the serious consequences of lax safety.
Dozens of CDC lab workers were potentially exposed to anthrax when samples were inadequately inactivated before being sent to a less protective lab, and an avian influenza culture contaminated with a highly pathogenic H5N1 strain was sent to a U.S. Department of Agriculture lab.
CDC director Thomas Frieden, MD, temporarily shut down the Bioterrorism Rapid Response and Advanced Technology lab and placed a moratorium on sending biomaterials from high-level labs until safety issues could be addressed.
Frieden called the incidents "a symptom of a broader problem of laboratory safety," as employees who routinely work with dangerous pathogens apparently became complacent. "The fact that something like this could happen in such a superb laboratory is unsettling because it tells me that we need to look at our culture of safety throughout all of our laboratories," he said in a press conference.
The CDC incidents are a safety wake-up call for all labs, including hospital diagnostic and research labs, says Dan Scungio, MT(ASCP), SLS, CQA(ASQ), laboratory safety officer at Sentara Healthcare in Norfolk, VA, and a lab safety consultant. "To me, the clear message is that it can happen to anybody," he says. "If you’re being complacent about your lab safety program, it’s going to happen to you. It doesn’t matter who you are."
The average hospital doesn’t typically deal with the sort of agents found in CDC’s high level labs. But worldwide travel ensures that potentially lethal and even obscure infectious diseases can emerge almost anywhere.
"Any hospital can isolate one of these dangerous organisms at just about any time," says Michael Miller, PhD, D(ABMM), former associate director for laboratory science at the CDC’s National Center for Emerging and Zoonotic Infectious Diseases and now a private clinical microbiology laboratory consultant based in Dunwoody, GA. "In fact, if you think about it, virtually any infectious disease on the planet is only one to two days away from the United States, in today’s world of travel and rapid movement of people."
Safety audits to reduce risk
In the anthrax case, scientists used a sterilization method for non-spore forming bacteria, although anthrax is spore-forming. And they failed to confirm that the anthrax was completely inactive before transferring the samples to other labs.
How did the errors happen? To find out, CDC immediately began an internal investigation into the events and established an external advisory group for laboratory safety. Frieden also named Michael Bell, MD, deputy director of CDC’s Division of Healthcare Quality Promotion, the new director of laboratory safety, reporting directly to the CDC director.
"Our first effort is to understand fully what happened and remediate it here at CDC, but we are definitely looking at the implications for laboratories around the country and around the world," Frieden said.
An investigation concluded that CDC lacked adequate biosafety policies and procedures and that existing procedures were not always followed.1
Hospitals also have been advised not only to review their biosafety procedures, but to monitor adherence. Safety audits should be routine in hospital laboratories, including observations of employees to ensure that they are using appropriate personal protective equipment, says Scungio.
A blue ribbon panel convened by CDC in 2008 urged hospitals to conduct risk assessments, identifying hazardous materials and activities and taking steps to reduce risk. Those measures have to be continually reinforced, says Miller, a member of the panel and lead author of CDC’s Guidelines for Safe Work Practices in Human and Animal Medical Diagnostic Laboratories.
In the CDC incidents, there was no failure in structural safety mechanisms, such as air handling, he notes. Rather, the problem stemmed from human error, including the failure to follow proper protocol to inactivate the anthrax and failure to promptly report the influenza contamination.
"I think it was just the failure of personnel to follow the rules very, very strictly," says Miller. "When safety policies are developed and approved for this type of organism, it’s extremely imperative that all laboratory workers pay very close attention every single day."
Training is a key component of any safety program, and it will be a part of the review of the safety lapses, Frieden said.
In fact, continual training and safety awareness is critical to building a culture of safety, says Miller. "This concept of safety is very important and it needs to be drilled into people when they first choose health care as a career," he says.
Annual training, risk assessment
The CDC guidelines recommend annual training that includes laboratory safety policies and precautions, how to work in a biological safety cabinet, emergency procedures, risk assessment and reporting of exposures, and personal protective equipment.
Researchers working with high-level containment need specific training on the pathogens they work with and continual professional development, said Sean Kaufman, president of Behavioral-Based Improvement Solutions, a biosafety training consulting firm. In testimony at a recent Congressional oversight hearing, he urged CDC not to focus on punitive actions against the employees involved but to look at organizational factors, such as inadequate training.
"This is a systemic problem not only for this laboratory at CDC, but for the majority of research laboratories around the world," he said.
Occ health response lacking
CDC’s occupational health response also was inadequate, according to a pre-hearing memo compiled by Congressional staff.2
Two potentially exposed laboratory scientists were treated in an emergency department with antibiotics. The agency’s Occupational Health Clinic quickly became overwhelmed with providing post-exposure prophylaxis with antibiotics and vaccine to dozens of potentially exposed employees.
"Staff left the clinic without knowing the extent of their risk of exposure," the memo said. "At least some of the lab workers who potentially were exposed in the most recent incident were not examined for five days following notification."
"We’re very concerned about the health and well-being of our own staff," Frieden said in a press conference. "And the fact that they had to deal with uncertainty, stress, potential risk and to take preventive medicines that can have adverse events as a result of this incident is something that I feel terrible about, and I wish had not happened."
In the future, CDC will use its incident management system to improve communication and response, he said.[Editor’s note: The CDC guidelines for safe work practices in labs are available at www.cdc.gov/mmwr/pdf/other/su6101.pdf.]
- Centers for Disease Control and Prevention. Report on the potential exposure to anthrax. July 11, 2014: http://www.cdc.gov/od/science/integrity/docs/Final_Anthrax_Report.pdf 2014.
- Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, U.S. House of Rep. Memorandum: Hearing on "Review of CDC Anthrax Lab Incident." July 14, 2014.
Will OSHA enforcement target hospital MSDs?
Musculoskeletal disorders are the No. 1 injury in health care, but OSHA has never cited a hospital for the hazard of patient handling under the general duty clause. That may soon change, cautions Eric Conn, JD, chair of the OSHA Practice Group at Epstein Becker Green in Washington, DC.
In January, OSHA launched a website with extensive resources on health care worker safety. (www.osha.gov/dsg/hospitals/)It focuses primarily on safe patient handling. That helpful resource is likely to be followed by a new enforcement focus, Conn predicts.
"I fully expect on the heels of this very robust guidance on hospital safety that we’re going to see a national emphasis program or regional emphasis programs addressing the items raised in this guidance," he says. OSHA inspectors could point to the resource as evidence of known hazards and accepted safety practices, he adds.
Employees also could use the OSHA guidance as a basis for complaints about patient handling hazards, he says. "The more you educate and publish OSHA’s expectations, the employees in those industries use those resources as a basis for more complaints," he says.
So what should an employer do? "These are good ways to improve safety at your hospital," he says. "Look at them and see what makes sense for you."
