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

2021 ◽  
Author(s):  
Nancy E. Cornish ◽  
Nancy L. Anderson ◽  
Diego G. Arambula ◽  
Matthew J. Arduino ◽  
Andrew Bryan ◽  
...  
Keyword(s):  
Public Health ◽  
Patient Care ◽  
Laboratory Testing ◽  
Clinical Laboratory ◽  
Lessons Learned ◽  
Infectious Agents ◽  
Testing Procedures

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.

National Inventory of Clinical Laboratory Testing Services (NICLTS)

2000 ◽  
Vol 124 (8) ◽  
pp. 1201-1208 ◽  
Author(s):  
Steven J. Steindel ◽  
William J. Rauch ◽  
Marianne K. Simon ◽  
James Handsfield
Keyword(s):  
Public Health ◽  
United States ◽  
Health Care ◽  
Laboratory Testing ◽  
Clinical Laboratory ◽  
The United States ◽  
High Complexity ◽  
Specimen Type ◽  
The Us ◽  
Clinical Laboratory Testing

Abstract Context.—A statistically valid inventory of the distribution, both geographic and by laboratory type, of clinical and anatomical laboratory testing in the United States is needed to assess the impact of the Clinical Laboratory Improvements Amendments of 1988 and to provide information for other health care and public health policy decisions. Objective.—To present initial US laboratory testing volume data compiled by the National Inventory of Clinical Laboratory Testing Services. Design.—Stratified random sample of laboratories performing testing in 1996 with data on the number of laboratory tests performed, identified by method and analyte. Data were collected by field tabulators (moderate- or high-complexity laboratories) or through a mail/telephone survey (waived or provider-performed microscopy laboratories) for each site. Participants.—Laboratories that were enrolled in the 1996 Online Certification Survey and Reporting System, maintained by the US Health Care Finance Administration, and that performed laboratory testing during 1996. Main Outcome Measure.—Laboratory testing distribution for 1996 in the United States by analyte, method, and specimen type. Results.—An overall response rate of 79% provided data from 757 moderate- or high-complexity laboratories and 1322 waived or provider-performed microscopy laboratories. The estimated total US testing volume for 1996 was 7.25 ± 1.09 billion tests. Laboratories performing complex testing, defined as greater than 16 method/analyte/specimen type combinations, comprised 16% of the US laboratories by survey site, but performed 80% (95% confidence limits, 43% to 100%) of the testing volume. Glucose analysis was the most frequently performed test. Automated hematology and chemistry analyzers were the most frequently used methods. Conclusions.—A statistically valid, consistent survey of the distribution of US laboratory testing was obtained. Simple analysis of these data by laboratory type and geographic region can provide insights into where laboratory testing is performed. The study design allows extensions that will facilitate collection of additional data of importance to public health and medical care delivery.

scholarly journals Types of Assays for SARS-CoV-2 Testing: A Review

2020 ◽  
Vol 51 (5) ◽  
pp. e59-e65 ◽  
Author(s):  
Marie C Smithgall ◽  
Mitra Dowlatshahi ◽  
Steven L Spitalnik ◽  
Eldad A Hod ◽  
Alex J Rai
Keyword(s):  
Patient Care ◽  
Laboratory Testing ◽  
Clinical Laboratory ◽  
Point Of Care ◽  
Direct Patient Care ◽  
Point Of Care Testing ◽  
Clinical Laboratories ◽  
Novel Coronavirus ◽  
Outpatient Settings ◽  
Clinical Laboratory Testing

Abstract Clinical laboratory testing routinely provides actionable results, which help direct patient care in the inpatient and outpatient settings. Since December 2019, a novel coronavirus (SARS-CoV-2) has been causing disease (COVID-19 [coronavirus disease 2019]) in patients, beginning in China and now extending worldwide. In this context of a novel viral pandemic, clinical laboratories have developed multiple novel assays for SARS-CoV-2 diagnosis and for managing patients afflicted with this illness. These include molecular and serologic-based tests, some with point-of-care testing capabilities. Herein, we present an overview of the types of testing available for managing patients with COVID-19, as well as for screening of potential plasma donors who have recovered from COVID-19.

scholarly journals Strengthening Public Health in Wisconsin Through the Wisconsin Clinical Laboratory Network

2019 ◽  
Vol 134 (2_suppl) ◽  
pp. 6S-10S ◽  
Author(s):  
Allen C. Bateman ◽  
Erin J. Bowles ◽  
Erik Munson ◽  
Raymond P. Podzorski ◽  
Eric T. Beck ◽  
...  
Keyword(s):  
Public Health ◽  
Clinical Laboratory ◽  
Lessons Learned ◽  
Advisory Group ◽  
Outbreak Response ◽  
University Of Wisconsin ◽  
Clinical Laboratories ◽  
Laboratory Network ◽  
Technical Advisory Group ◽  
The University

The Wisconsin Clinical Laboratory Network (WCLN) at the University of Wisconsin–Madison is a partnership of 138 clinical and public health laboratories (as of February 2019) coordinated by the Wisconsin State Laboratory of Hygiene. This article describes the WCLN, its current activities, and lessons learned through this partnership. A laboratory technical advisory group, which consists of representatives from clinical laboratories, provides clinical laboratory perspective to the WCLN and fosters communication among laboratories. Activities and resources available through the WCLN include annual regional meetings, annual technical workshops, webinars, an email listserv, laboratory informational messages, in-person visits by a WCLN coordinator to clinical laboratories, and laboratory-based surveillance data and summaries distributed by the Wisconsin State Laboratory of Hygiene. One challenge to maintaining the WCLN is securing continual funding for network activities. Key lessons learned from this partnership of more than 20 years include the importance of in-person meetings, the clinical perspective of the laboratory technical advisory group, and providing activities and resources to clinical laboratories to foster sharing of data and clinical specimens for public health surveillance and outbreak response.

Characterization of Microorganism Identification in the United States in 1996

2001 ◽  
Vol 125 (7) ◽  
pp. 913-920
Author(s):  
Steven J. Steindel ◽  
Marianne K. Simon
Keyword(s):  
Public Health ◽  
United States ◽  
Laboratory Testing ◽  
Clinical Laboratory ◽  
Direct Methods ◽  
The United States ◽  
Test Method ◽  
Confidence Limits ◽  
Public Health Importance ◽  
Microorganism Identification

Abstract Context.—The National Inventory of Clinical Laboratory Testing Services (NICLTS) was designed to give an unbiased estimate of all patient testing performed by laboratories registered under the Clinical Laboratory Improvement Amendments in 1996. Objective.—Survey data were used to develop a profile of laboratory testing primarily intended to identify microorganisms or antibodies to these microorganisms. Design.—Estimates of the extent of microorganism identification were derived from the NICLTS database by identifying associated tests and methods. The volumes for tests performed at locations that primarily prepared blood components for distribution were excluded. Organisms of public health importance were identified from the National Notifiable Disease list maintained by the Centers for Disease Control and Prevention. Participants.—Laboratories that were enrolled in the 1996 Online Certification Survey and Reporting System, maintained by the US Health Care Finance Administration, and that performed laboratory testing in 1996. Outcome Measure.—Estimated volumes and associated confidence limits by test, method, specimen type, public health importance, and testing location. Results.—Excluding testing of the blood supply, 315 million tests (95% confidence limits, 280–354 million tests) were performed in the United States for microorganism identification. Those tests for which public health consensus requires national reporting represented 38% of this total. Although hospitals performed 46% of all microorganism identification, they only performed 33% of the testing for microorganisms of public health importance. Independent and specialty laboratories performed 38% of all testing but 65% of the testing for microorganisms of public health importance. Direct methods (methods not involving culture) were used in 77% of the tests for microorganisms of public health importance and in 42% of all identification tests. Conclusions.—The distribution of microorganism identification testing found using NICLTS data is consistent with plans to modernize the public health surveillance system in the United States.

CDC and Clinical Laboratory Partners: Analysis of Biosafety Gaps Revealed During the Ebola Outbreak

2019 ◽  
Vol 152 (Supplement_1) ◽  
pp. S139-S139
Author(s):  
Nancy Cornish ◽  
Sheldon Campbell ◽  
Elizabeth Weirich
Keyword(s):  
Patient Care ◽  
Health Care Providers ◽  
Laboratory Testing ◽  
Clinical Laboratory ◽  
The United States ◽  
Future Research ◽  
Competency Assessment ◽  
Care Providers ◽  
Clinical Laboratories ◽  
Clinical Laboratory Testing

Abstract Objectives Patient care and public health in the United States depend on timely and reliable clinical laboratory testing. A third of the roughly 500 million yearly patient visits to health care providers involve at least one laboratory test, and approximately 70% of medical decisions are based upon test results. However, the performance of clinical laboratory testing could be compromised by patient specimens potentially contaminated with highly infectious materials. The importance of biosafety in clinical laboratories was highlighted during the 2014 Ebola crisis, where fears about safety resulted in some institutions refusing or delaying tests on patient specimens, which resulted in delayed diagnoses and contributed to patient deaths. Methods In collaboration with subject matter experts from academia, medical centers, and federal institutions, the Centers for Disease Control and Prevention has reviewed the capability of clinical laboratories to safely test patient specimens potentially contaminated with highly infectious materials, like Ebola. Current biosafety guidance for clinical laboratories has been largely based on biosafety practices in research laboratories, so the guidelines do not always correspond to clinical laboratories and may be incomplete or occasionally inconsistent. While essential to patient care, clinical laboratories are also unique environments with specialized equipment, processes, and therefore distinct challenges. Here we discuss the complexity of clinical laboratories and describe how applying current biosafety guidance to clinical laboratories may be difficult and confusing at best or inappropriate and harmful at worst. We describe biosafety gaps and opportunities for improvement in the areas of ethics; risk assessment and management; automated and manual laboratory disciplines; specimen collection, processing, and storage; test utilization; waste management; laboratory personnel training and competency assessment; and accreditation processes. Conclusion These identified gaps in knowledge and practice could inform future research and education in clinical laboratory biosafety.

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