TY - JOUR
T1 - Clinical laboratory biosafety gaps
T2 - Lessons learned from past outbreaks reveal a path to a safer future
AU - Cornish, Nancy E.
AU - Anderson, Nancy L.
AU - Arambula, Diego G.
AU - Arduino, Matthew J.
AU - Bryan, Andrew
AU - Burton, Nancy C.
AU - Chen, Bin
AU - Dickson, Beverly A.
AU - Giri, Judith G.
AU - Griffith, Natasha K.
AU - Pentella, Michael A.
AU - Salerno, Reynolds M.
AU - Sandhu, Paramjit
AU - Snyder, James W.
AU - Tormey, Christopher A.
AU - Wagar, Elizabeth A.
AU - Weirich, Elizabeth G.
AU - Campbellj, Sheldon
N1 - Publisher Copyright:
© 2021 American Society for Microbiology. All Rights Reserved.
PY - 2021
Y1 - 2021
N2 - 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.
AB - 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.
KW - Biosafety
KW - Clinical laboratories
KW - Disinfection
KW - Ethics
KW - Laboratory equipment
KW - Laboratory testing
KW - Personal protective equipment
KW - Risk assessment
KW - Specimen collection and transport
KW - Waste management
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U2 - 10.1128/CMR.00126-18
DO - 10.1128/CMR.00126-18
M3 - Review article
C2 - 34105993
AN - SCOPUS:85108386427
SN - 0893-8512
VL - 34
JO - Clinical Microbiology Reviews
JF - Clinical Microbiology Reviews
IS - 3
M1 - e00126-18
ER -