Clinical Laboratory Biosafety Gaps: Lessons Learned from Past Outbreaks Reveal a Path to a Safer Future

Abstract

Patient care and public health require timely, reliable laboratory testing. However, clinical laboratory professionals rarely know whether patient specimens contain infectious agents, making ensuring biosafety while performing testing procedures challenging. The importance of biosafety in clinical laboratories was highlighted during the 2014 Ebola outbreak, where concerns about biosafety resulted in delayed diagnoses and contributed to patient deaths. This review is a collaboration between subject matter experts from large and small laboratories and the federal government to evaluate the capability of clinical laboratories to manage biosafety risks and safely test patient specimens. We discuss the complexity of clinical laboratories, including anatomic pathology, and describe how applying current biosafety guidance may be difficult as these guidelines, largely based on practices in research laboratories, do not always correspond to the unique clinical laboratory environments and their specialized equipment and processes. We retrospectively describe the biosafety gaps and opportunities for improvement in the areas of risk assessment and management; automated and manual laboratory disciplines; specimen collection, processing, and storage; test utilization; equipment and instrumentation safety; disinfection practices; personal protective equipment; waste management; laboratory personnel training and competency assessment; accreditation processes; and ethical guidance. Also addressed are the unique biosafety challenges successfully handled by a Texas community hospital clinical laboratory that performed testing for patients with Ebola without a formal biocontainment unit. The gaps in knowledge and practices identified in previous and ongoing outbreaks demonstrate the need for collaborative, comprehensive solutions to improve clinical laboratory biosafety and to better combat future emerging infectious disease outbreaks.

Keywords: biosafety; clinical laboratories; disinfection; ethics; laboratory equipment; laboratory testing; personal protective equipment; risk assessment; specimen collection and transport; waste management.

FIG 1

Hierarchy of resistance to disinfection and sterilization. The hierarchy of microbial resistance to disinfection and sterilization. Selection of disinfectants for pathogens should be based on a well-established hierarchy of susceptibility to chemicals as determined by the microbes’ biophysical characteristics (adapted from reference 114).

FIG 2

Proposed PPE for specimen collection, transport, and specimen testing: high to moderate risk patients. PPE associated with specimen collection, transport, and testing of patients designated high to moderate risk for a highly infectious agent.

FIG 3

Sample checklist to document risk assessment from APHL (171). An example checklist to document risk assessment from APHL. CDC’s Guidelines for Safe Work Practices in Human and Animal Medical Diagnostic Laboratories is available at https://www.cdc.gov/mmwr/pdf/other/su6101.pdf and the Biosafety Website is available at https://www.cdc.gov/safelabs/resources-tools.html. The ABSA Advanced Biosafety Training Series, including the module containing the checklist, can be accessed at https://absa.org/abts/. (Reproduced from reference . © Association of Public Health Laboratories. Reprinted with permission; all rights reserved.)

FIG 4

Sample equipment-specific risk assessment (277). An example of an equipment-specific risk assessment from Yale-New Haven Health System Department of Laboratory Medicine. (Reproduced from reference with permission of Yale-New Haven Health System.)

FIG 5

Example intensive care unit test menu used at Texas Health Dallas. This example test menu was used by Texas Health Dallas during the 2014 Ebola event. (Courtesy of Texas Health Dallas, reproduced with permission.)

FIG 6

Emerging infectious agent referral testing menu used by Texas Health Dallas during the Ebola event. UTM, universal transport medium; NP, nasopharyngeal; CBC, complete blood count; ARUP, ARUP laboratories; THD, Texas Department of Health; HUB, centralized microbiology HUB laboratory. (Courtesy of Texas Health Dallas, reproduced with permission.)

FIG 7

Example emergency department test menu from Texas Health Dallas. (Courtesy of Texas Health Dallas, reproduced with permission.) TDH, Texas Department of Health.

FIG 8

The hierarchy of controls as described by CDC (www.cdc.gov/niosh/topics/hierarchy/default.html).