Safety Considerations in Diagnostic Laboratory Testing of Specimens Suspected or Known to Contain the Virus Causing COVID-19

By: Karen L. Stiles and Susanne Peters, MT(ASCP) 

On March 11, 2020, the World Health Organization (WHO) declared a global pandemic of COVID-19, the disease caused by the virus SARS-CoV-2. This virus meets all three criteria of a pandemic; it causes disease and death, is capable of sustained person-to-person transmission, and is spreading worldwide. As COVID-19 develops into community-spread disease in the U.S., our clinical and public health laboratories (PHL) are becoming overwhelmed. The CDC established an RT-PCR assay for use in all PHLs, and continues to work with commercial laboratories to expand testing capacity for the private setting. The purpose of this article is to encourage all diagnostic laboratories to improve the level of safety, for the sake of their laboratorians, in order to prevent the possibility of a laboratory-acquired infection (LAI).

Due to lab staff shortages, overwhelming workloads and lack of funding, laboratorians are at higher risk for infection, if not fully prepared. Only a small percentage of clinical laboratories have performed documented risk assessments (RA) 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 the 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 CDC’s three-year effort to incorporate the “Culture of Safety[1]” by hiring a biosafety officer, efforts were placed on enhancing the PHLs biosafety, and may not have fully involved clinical diagnostic laboratories.

Public Health Laboratories can play a larger role, not only to lobby Centers for Medicare and Medicaid Services (CMS) and College of American Pathologist (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 the Risk Assessment. The Association of Public Health Laboratories (APHL) released the “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 mask.[2]  Clinical laboratories can apply the lessons learned from Ebola to the current COVID-19 outbreak. It is imperative to perform RA on all laboratory procedures in which the virus may be present in specimens. The RA 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 OSHA investigation of an LAI, particularly in the case of a death.  

Laboratorians should understand the concept of using 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[3]. Few laboratories have incorporated N95s into their inventory unless TB is processed on-site. Laboratories and clinics would benefit from providing inventory and continued use of the N95 respirators when performing 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. CDC comments state that surgical masks are an option in the laboratory, but this type of mask is designed to prevent an infectious person from spreading the virus, and less for protection of the lab staff wearing the mask. The main advantage of the surgical mask is to 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.

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 mindfully remove gloves every time when exiting 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 setting. These are typically not used due to cost or space, but is it worth the cost of a laboratory-acquired infection?

Lab management should be encouraged to monitor PPE usage and to voluntarily incorporate extensive biosafety tasks into the competency program, even if it not detailed in federal requirements. PHL can provide assistance on RA so clinical laboratories go beyond the Individualized Quality Control Plan (IQCP), and fully document an RA with steps to mitigate each risk. Portions can be incorporated into the Laboratory Response Network (LRN) training currently taught in the clinical laboratory setting. In order for PHLs to play a larger role with clinical laboratories within the state, additional federal funding is necessary to promote better training. No other organization can instill these practices like PHLs, as they provide education and consultation for the clinical laboratories[4].

In conclusion, now is the time which laboratorians should 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 healthcare 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 such funding can improve training efforts to teach risk assessments and biosafety measures to mitigate the risks to clinical laboratory staff.

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 REFERENCES

[1] https://www.cdc.gov/media/releases/2020/t0225-cdc-telebriefing-covid-19.html

[2] https://urldefense.com/v3/__https://www.cnn.com/2020/02/26/opinions/colleen-kraft-coronavirus-best-defense/index.html

[3] Centers for Disease Control and Prevention. Guidelines for Safe Work Practices in Human and Animal Medical Diagnostic Laboratories. MMWR 2011;60(Suppl):p2

[4] Safety Considerations in the Laboratory Testing of Specimens Suspected or Known to Contain the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2); Peter C Iwen, PhD, D(ABMM), F(AAM); Karen L Stiles, SM(ASCP)CM; Michael A Pentella, PhD, D(ABMM) ; Mar 2020

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