On March 11, 2020, the World Health Organization (WHO) declared COVID-19—the disease caused by the virus SARS-CoV-2—a global pandemic. As COVID-19 has developed into a community-spread disease in the US, our clinical and public health laboratories (PHLs) are becoming overwhelmed. The purpose of this article is to encourage all diagnostic laboratories to improve their level of safety, for the sake of their laboratorians, in order to prevent the possibility of a laboratory-acquired infection.
Due to lab staff shortages, overwhelming workloads, and lack of funding, laboratorians are at high risk for infection if not fully prepared. Only a small percentage of clinical laboratories have performed documented risk assessments on hazardous procedures or implemented effective training in biosafety. Laboratorians complete annual training in blood-borne pathogens, but biosafety training tends to be overlooked or only mentioned upon hire. Additionally, biosafety and use of personal protective equipment (PPE) or the biosafety cabinet (BSC) are not built into the laboratory competency program where laboratorians are observed for breach of safe PPE or BSC usage. Despite the Centers for Disease Control and Prevention’s (CDC’s) three-year effort to incorporate a culture of safety by hiring a biosafety officer, it placed focus on enhancing the PHL biosafety and may not have fully involved clinical diagnostic laboratories.
Public health laboratories have a key role to play, not only to lobby Centers for Medicare and Medicaid Services (CMS) and College of American Pathologists (CAP) for safer regulations, but also to connect with clinical laboratories in each state, train on risk assessments and biosafety, and assist in the incorporation of competency policies regarding biosafety and PPE measurements. Currently, there is little regulatory oversight for a laboratory to attain biosafety to its fullest extent. Accrediting agencies must be asked to be more comprehensive in their biosafety checklist/inspection process. Safety in clinical laboratory settings must be immediately improved in order to be prepared for the imminent threat of a COVID-19 outbreak. Clinical laboratories must voluntarily boost their safety by implementing all possible safety precautions.
With the introduction of Ebola in the US, PPE requirements were enhanced with the use of risk assessments. The Association of Public Health Laboratories released risk assessment best practices, which detailed key components including workforce needs, risk characterization, and risk mitigation. Two points of highest risk for self-contamination were insufficient hand hygiene and unsafe removal of gloves and masks. Clinical laboratories can apply the lessons learned from Ebola to the current COVID-19 outbreak. It is imperative to perform risk assessments on all laboratory procedures in which the virus may be present in specimens. The risk assessment must be written and documented by lab managers, who must ensure laboratory staff has been consistently trained. Competency in PPE donning, use, and doffing, and other risk-mitigating procedures developed by the administration should be routinely assessed. This documentation may be required during an Occupational Safety and Health Administration (OSHA) investigation of a laboratory-acquired infection, particularly in the case of a death.
Biosafety level 3 practices
Laboratorians should understand the concept of using biosafety level (BSL) 3 practices in a clinical BSL-2 laboratory. BSL-3 practices require protection of eyes and mouth with the use of N95 respirators and disposable face shields, in addition to universal precautions of impermeable lab coats and gloves. Few laboratories have incorporated N95s into their inventory unless tuberculosis is processed on-site. Laboratories and clinics would benefit from providing inventory and continued use of the N95 respirators when per-forming rapid detection tests. Microbiology laboratories can benefit from using N95s in the BSC when ruling out a suspect hazardous pathogen such as Brucella or Francisella. The CDC states that surgical masks are an option in the laboratory, but this type of mask is designed more to prevent an infectious person from spreading the virus, and less for protection of the lab staff wearing the mask. The main advantage of surgical masks is that they keep the laboratorian from touching the face. Due to the shortage of N95 respirators, surgical masks may be the only option at this time in the laboratory.
The workflow within the BSC should be articulated in the written laboratory policy to include disinfection of all specimen collection devices after removal from biohazard bags (each specimen should be transported in individual bags after collection), placing absorbent pads under the work area, working from clean to dirty side, covering all tubes with absorbent squares when opening, disinfecting gloves multiple times, and ideally providing a trained observer to point out risk during a procedure. Multiple glove changes inside the BSC or immediately at exit of the cabinet should be written into policy. Staff must mind-fully remove gloves every time they exit the BSC, even if it’s only to obtain something forgotten. This is a critical time when laboratorians must make improvements, such as adding centrifuges with closed rotors in their clinical settings. These are typically not used due to cost or space, but is it worth the cost of a laboratory-acquired infection?
PHLs can provide assistance
Lab management should be encouraged to monitor PPE usage and to voluntarily incorporate extensive biosafety tasks into the competency program, even if it is not detailed in federal requirements. PHLs can provide assistance on risk assessment to help clinical laboratories go beyond the individualized quality control plan and fully document a risk assessment with steps to mitigate each risk. Portions can be incorporated into the Laboratory Response Network training currently taught in the clinical laboratory setting. In order for PHLs to play a larger role with clinical laboratories within the state, the additional federal funding is necessary to promote better training. No other organizations can instill these practices like PHLs, as they provide education and consultation for the clinical laboratories.
Now is the time for laboratorians to take safety into their own hands. Employers should provide every possible PPE measure, as well as administrative and engineering controls (including safer centrifuges), to keep staff safe, but each individual laboratorian must also be willing to take responsibility to protect themselves. Unfortunately, the virus causing the COVID-19 disease is new and not well understood. Obviously, this specific coronavirus may not require the full precautions for Ebola, but until the scientific world knows exactly how dangerous this virus is, laboratories must take an abundance of precaution. Ebola taught all health care facilities extreme measures to enhance safety during patient management and laboratories must follow suit. Eventually, PHLs can be a principal resource to guide clinical settings but not without additional federal funding. Only funding can improve training efforts to teach risk assessments and biosafety measures to mitigate the risks to clinical laboratory staff.
This article was authored by the Clinical Laboratory Management Association (CLMA), an international association providing support, resources, and advocacy in the clinical laboratory industry. For more information and discussion on COVID-19 related to laboratory professionals, please visit www.clma.org/covid-19.