Advancing Clinical Laboratory Biosafety From A National Perspective
Reynolds M Salerno, PhDDirector, Division of Laboratory Systems
June 3, 2019
Presenter
Presentation Notes
This presentation will describe CDC’s work to improve risk management in clinical and public health laboratories across the United States – from standards and guidance to training and workforce development.
Excellent Laboratories, Outstanding Health
Introduction
Division of Laboratory Systems 2
Challenges in clinical and public health laboratory biosafety remain
Presenter
Presentation Notes
Public health laboratory biosafety identified as an important issue in 2014 Short-term federal funding for public health laboratories has come to an end Challenges in clinical and public health laboratory biosafety remain Without dedicated funding, CDC remains committed to advancing biorisk management in clinical and public health laboratories
Excellent Laboratories, Outstanding Health
$21M over 2016-2018 to Enhance Biosafety
Division of Laboratory Systems 3
Creation of 62 biosafety
positions
Biosafety training and
tools
Outreach to sentinel clinical
laboratories
CDC/APHL Biosafety and
Biosecurity Program
Presenter
Presentation Notes
FY16, FY17, FY18 With the end of this dedicated, one-time allocation for biosafety, CDC no longer has a funded program to advance laboratory biosafety across the United States Today the US is more assertively advancing laboratory biosafety internationally than domestically Creation of full-time biosafety positions in 62 public health laboratory jurisdictions Training and tools to support the development of risk assessments, mitigation measures, and biosafety plans Outreach to sentinel clinical laboratories CDC/APHL Biosafety and Biosecurity Program
Excellent Laboratories, Outstanding Health
Laboratory Exposures to Brucella, 2015-2017
• Samples from nine separate patients resulted in– 88 high-risk exposures
– 101 low-risk exposures
– 64 placed on prophylaxis
– 187 under serological surveillance
Gram stain image from Camille Hamula, PhD, D(ABMM), Mount Sinai Hospital, New York
4
Division of Laboratory Systems 4
Data from Joel Ackelsberg, MD, MPH, NYC Department of Health and Mental Hygiene, Bureau of Communicable Diseases
Presenter
Presentation Notes
Although we have seen some distinct improvements in many public health laboratories in the US, safety problems in our clinical laboratories continue. For example, NYC has documented a high number of laboratory exposures to Brucella over the last two years. There have been nine patient incidents that have resulted in 88 high-risk exposures, 101 low-risk exposures, 64 individuals placed on prophylaxis, and 187 under serological surveillance. Based on studies by the NYC Department of Health and Mental Hygiene, the primary cause seems to be doing diagnostic work on an open bench top, with MALDI TOF preparation accounting for 63% of the accidental exposures. Fortunately, none of these exposures resulted in a LAI. *************************** Procedures done on open bench during incidents Venting blood cultures: 3/8 (38%) Streaking of solid media: 4/8 (50%) Catalase test: 3/8 (38%) MALDI TOF MS preparation: 5/8 (63%) Automated identification system sample prep: 4/8 (50%) Median # days worked with isolate on bench: 2 (range 1-7) Small, slow-growing Gram negative coccobacilli; Readily aerosolized during routine lab work; Infectious dose extremely low Symptoms: intermittent or undulant fever; night sweats; weight loss; fatigue; and joint pain Brucellosis symptoms in 7/9 (78%) patients; Brucellosis risk factors in 8/9 (89%) patients; Brucellosis not suspected by clinicians in any of patients Gram stain image from Camille Hamula PhD, D(ABMM), Mount Sinai Hospital New York Lab exposure data from Joel Ackelsberg, MD, MPH, NYC Department of Health and Mental Hygiene, Bureau of Communicable Diseases
Excellent Laboratories, Outstanding Health
Laboratory Infections of Salmonella, 2011-2017
5
Division of Laboratory Systems
As of June 29, 2011: www.cdc.gov/salmonella/2011/lab-exposure-1-17-2012.html
5
Presenter
Presentation Notes
Laboratory Infections of Salmonella Typhimurium associated with clinical and teaching labs: 2010-11 – 109 cases in 38 states, 13 hospitalizations, 1 death 2013-14 – 41 cases in 13 states, 14 hospitalizations, 0 deaths 2017 – 24 cases in 16 states, 6 hospitalizations, 0 deaths For example, Salmonella spp. is commonly referred to as a Risk Group 2 organism, to be worked with under BSL2 conditions. But risk groups only refer to the significance of the disease caused by the agent. Risk groups do not reflect the risk of transmission in a specific laboratory environment, and definitely should not be linked to a particular biosafety level. In October 2010, PulseNet, the national molecular subtyping network for foodborne disease surveillance, detected a multi-state cluster of Salmonella Typhimurium infections. 109 individuals from 38 states were infected with a clinical laboratory strain of Salmonella Typhi. This map reflects persons infected with the outbreak strain of Salmonella Typhi by state as of June 29, 2011. In all likelihood, this represents a significant undercount, since many salmonella infections go undetected and unreported. This outbreak, which originated in clinical and teaching laboratories, resulted in 12 hospitalizations and one death. ************ http://www.cdc.gov/salmonella/2011/lab-exposure-1-17-2012.html
Excellent Laboratories, Outstanding Health 6Division of Laboratory Systems
US Clinical Laboratory Improvement Advisory Committee, April 2016
OSHA General Duties Clause: “Each employer shall furnish to each of his employees employment and a place of employment which are free from recognized hazards that are causing or are likely to cause death or serious physical harm to his employees.” The HIV crisis of the 1980s led to the passage of far-reaching regulations and guidelines in the early 1990s that reduced the potential exposure of employees to bloodborne pathogens and required the safe disposal of biohazardous waste. The CLIA regulations, which went into effect in 1992, focus on the quality and reliability of laboratory diagnostic tests, not on safety. There are sections in CLIA that refer to safety, but only generally. In summary, CLIA says that the laboratory’s environment must be appropriate for the testing performed, and that safety procedures must be established to protect employees against hazards. There is nothing in CLIA that refers to biosafety specifically, and nothing that explains how laboratory safety systems should be designed and implemented. CLIA surveyors generally do not focus on safety, and, thus, many (if not most) clinical laboratories also do not prioritize safety. Clinical laboratory medicine is a regulated industry in the US, but there are not national regulations for clinical laboratory safety and/or biosafety. Some suggest this means that clinical laboratories will not prioritize the implementation of safety, especially if they perceive it as a supplemental function and expense.
Excellent Laboratories, Outstanding Health
Additional National Challenges
Division of Laboratory Systems 8
Inconsistent and/or
inadequate guidance
Lack of dependable, high-quality
training materials or curriculum
Inadequate preparedness for handling public health emergencies
Presenter
Presentation Notes
Inconsistent and/or inadequate guidance Agent-based approach to risk assessments and biosafety Safety incidents basis for determining safety effectiveness Lack of consistent, high-quality training materials or curriculum Lack of preparedness for handling emerging infectious diseases and unusual outbreaks Added time burden - clinical labs don't feel that they have the time to add more safety procedures (eg, filtering sample before inserting on MALDI) But the result, as Ebola showed, is that, as a whole, and because of weaknesses in biosafety, we are not prepared for handling emerging infectious diseases and unusual outbreaks in our clinical laboratories. We find ourselves with a system in which fear of the unknown may outweigh rational decision-making and the priority to deliver excellent and timely patient care.
Excellent Laboratories, Outstanding Health
Division of Laboratory Systems (DLS)
Quality Laboratory Science
Division of Laboratory Systems 9
Highly Competent Laboratory Workforce
Safe and Prepared Laboratories Accessible and Usable Laboratory Data
Presenter
Presentation Notes
Quality Laboratory Science: Improve the quality and value of laboratory medicine and biorepository science for better health outcomes and public health surveillance Highly Competent Laboratory Workforce: Strengthen the laboratory workforce to support clinical and public health laboratory practice Safe and Prepared Laboratories: Enhance the safety and response capabilities of clinical and public health laboratories Accessible and Usable Laboratory Data: Increase access and use of laboratory data to support response, surveillance, and patient care
Excellent Laboratories, Outstanding Health
Some DLS Initiatives in Laboratory Biosafety
• Clinical laboratory biosafety needs assessment with APHL
• Laboratory biosafety training courses (e.g. Biosafety Cabinet, Chemical Fume Hood, Centrifuge Safety)
• CLSI guidance document: “Decontamination of Laboratory Equipment and Instrumentation” (QMS27)
World Health OrganizationLaboratory Biosafety Manual
Excellent Laboratories, Outstanding Health
CDC 16th International Biosafety Symposium
“The Power of Safety,” March 2020, Atlanta, GA
12Division of Laboratory Systems
Presenter
Presentation Notes
March 2020 will be the first year of DLS being in charge of the CDC International Biosafety Symposium. Theme: “The Power of Safety” and the positive impacts of risk assessment for clinical/diagnostic, research, and public health laboratories Two days of pre-symposium workshops plus two and one-half days of keynote speakers, panels, and breakout sessions The purpose of this symposium is to promote the principles and practices of laboratory safety with a focus on the needs of the biosafety community at large with specific focus on clinical and diagnostic laboratory community. The overall theme of the 16th CDC International Biosafety Symposium is Risk Assessment. Presented By: Centers for Disease Control and Prevention (CDC), in partnership with the Eagleson Institute and the American Biological Safety Association (ABSA International) sented By: Centers for Disease Control and Prevention (CDC), in partnership with the Eagleson Institute and the American Biological Safety Association (ABSA International)
We are in the process of operationalizing a biorisk management curriculum framework that was developed with partners. The drafted curriculum framework will help develop future training curricula and other workforce development resources with a targeted and structured approach.
Excellent Laboratories, Outstanding Health
Influence Laboratory Accreditation
Engage clinical laboratory accreditation organizations, and encourage oversight of safety in addition to quality
Division of Laboratory Systems 15
Excellent Laboratories, Outstanding Health
Evidence-Based Biosafety Research
Conduct hypothesis-driven controlled laboratory experiments to determine the effectiveness of “best laboratory practices and biosafety”
Division of Laboratory Systems 16
Presenter
Presentation Notes
Further studies will drive biosafety guidance based on scientific data Many of the current laboratory practices are based on experience, “expert” opinion, and common sense Evidence for the effectiveness of containment measures is at best indirect, i.e., based on the lack of many overt laboratory-acquired infections (LAIs) Actual number of LAIs or other laboratory accidents is unknown Need for hypothesis-driven controlled laboratory experiments to determine the effectiveness of “best laboratory practices and biosafety” Further studies will drive biosafety guidance based on scientific data Kimman, et al., “Evidence-Based Biosafety: a Review of the Principles and Microbiological Containment Measures,” Clinical Microbiology Reviews. (https://cmr.asm.org/content/21/3/403)
Excellent Laboratories, Outstanding Health
Summary
Division of Laboratory Systems 17
CDC remains committed to advancing bioriskmanagement across the public health and clinical laboratory community
Presenter
Presentation Notes
Considerable progress has been made in public health laboratory biosafety since 2014 Challenges and gaps remain for clinical and public health laboratory biosafety Despite not having dedicated funding for this issue, CDC remains committed to advancing biorisk management across the public health and clinical laboratory community
Excellent Laboratories, Outstanding Health
For more information, contact CDC1-800-CDC-INFO (232-4636)TTY: 1-888-232-6348 www.cdc.gov
Images used in accordance with fair use terms under the federal copyright law, not for distribution.
Use of trade names is for identification only and does not imply endorsement by U.S. Centers for Disease Control and Prevention.
The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of Centers for Disease Control and Prevention. 18Division of Laboratory
