Public-Private Partnerships to Enhance Laboratory ...

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Public-Private Partnerships to Enhance Laboratory Preparedness and ResponseOctober 3, 2018

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Funding

This webinar was supported by Cooperative Agreement #NU60OE000103 funded by the Centers for Disease Control and Prevention. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of CDC or the Department of Health and Human Services.


Continuing Education Credits

The Association of Public Health Laboratories (APHL) is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. Participants who successfully complete this program will be awarded 1.0 P.A.C.E. contact hour.

Direct all PACE related questions to [email protected].


Moderator

Robert Nickla, M(ASCP)LRN Coordinator Oregon State Public Health [email protected]


SpeakersSteven D. Mahlen, PhD, D(ABMM) Clinical Microbiologist, Sanford Health [email protected]

Erin Bowles, BS, MT(ASCP)Clinical Laboratory Network Coordinator and Co-Biosafety Officer Wisconsin State Laboratory of [email protected]

Maureen Sullivan, MPHEmergency Preparedness and Response Unit SupervisorMinnesota Department of Health, Public Health [email protected]


Objectives

• Identify current ASM initiatives and collaborative efforts to enhance laboratory preparedness and response.

• Describe strategies public health laboratories utilize to engage with clinical laboratories on training and biosafety initiatives.

• Select resources designed to both assist clinical laboratories with detection of biological threat agents and that articulate the role of sentinel clinical laboratories in the public health laboratory system.


ResourcesSentinel Clinical Laboratory Definition

(Revised in 2018)

https://www.asm.org/index.php/guidelines/sentinel‐guidelines

Sentinel Clinical Laboratory Biothreat Protocols


Resources

APHL Biothreat Agent Rule-Out or Refer Bench Cards

APHL Biothreat Agent Poster

https://www.aphl.org/aboutAPHL/publications/Pages/list-of-publications.aspx


Additional APHL Resources

Biosafetyhttps://www.aphl.org/programs/preparedness/Biosafety-and-Biosecurity/Pages/default.aspx

Infectious Diseaseshttps://www.aphl.org/programs/infectious_disease/Pages/default.aspx

Steven Mahlen, PhD, D(ABMM)ASM Subcommittee on Laboratory Practices

Clinical MicrobiologistSanford Health Bismarck, Bismarck, ND

ASM Initiatives and Collaborative Efforts

ASM• Oldest and largest life science organization in the world

– Established in 1899• >30,000 members, 150+ countries• 27 disciplines of specialization

– Primary clinical microbiology division: Division C• Meetings and publications

– 7 conferences per year– 15 peer reviewed journals, many book titles

• Clinical microbiology list serves– Division C Net (DivCNet)– Clinical Microbiology (ClinMicroNet)

• Clinical and Public Health Microbiology (CPHM) Newsletter (published twice monthly)

ASM Clinical Committee Structure

Clinical and Public Health Microbiology Committee (CPHMC)

Professional Affairs

Professional Development/ Education

Clin Micro Mentoring

CPEP

ABMM

Personnel standards and lab workforce (new)

Clinical and Scientific Practices

Subcomm on Lab Practices

Evidence‐based reviews

Coding and Reimbursement

Subcommittee on Lab Practices(CLP)• CLP interacts with federal agencies, their programs, and

laboratory organizations such as:– Centers for Disease Control and Prevention (CDC)– US Food and Drug Administration (FDA)– Clinical Laboratory Improvement Advisory Committee (CLIAC)– US Technical Advisory Groups (TAG)– Association of Public Health Laboratories (APHL)– American Society for Clinical Pathology (ASCP)– Clinical & Laboratory Standards Institute (CLSI)– American Association for Clinical Chemistry (AACC)– Association for Molecular Pathology (AMP)– College of American Pathologists (CAP)– And others

CLP

• Examples of white papers/projects:– Letter, with other agencies, addressing Palmetto lab testing

reimbursement– Clinical utility of multiplex tests for respiratory and gastrointestinal

pathogens– VITEK 2 Gram positive antimicrobial susceptibility testing (AST) cards

recalled due to false results for some MRSA strains: what can your laboratory do?

• My role:– Coordinator of sentinel level lab guidelines– ASM liaison:

• APHL Sentinel Laboratory Partnerships and Outreach Subcommittee (SLPOS)• APHL Biosafety and Biosecurity Committee• CDC Division of Laboratory Systems Clinical Laboratory Partners Workgroup

Sentinel level lab guidelines

Sentinel Level Clinical Laboratory Protocols For Suspected Biological Threat Agents And Emerging Infectious Diseases Agents include:

– Anthrax– Brucella– Botulinum– BT Readiness Plan– Burkholderia– Coxiella burnetii– Novel influenza– Packing and shipping– Plague– Smallpox– Staphylococcal enterotoxin B– Tularemia


• Written by ASM subject matter experts• Goal is to have guidelines and procedures that make sense for the vast majority of sentinel level labs– Sentinel labs range in size from small to very large hospital and reference labs

– Many sentinel labs do not utilize reagents and biochemical tests that large labs may use


• Updates– Comments/suggestions come from:

• Clinical microbiology community• Public health community• Feedback from other experts/agencies

– Guidelines are reviewed, discussed in the SLPOS committee meetings

– Edits are reviewed (again) by SLPOS and CLP committees


• Biggest recent update: addition of Bacillus cereus biovar anthracis to Anthrax guideline– Added by CDC and Dept of Health and Human Services (HHS) as Tier 1 select agent, September, 2016

– Discussed at length in SLPOS• Two white papers sent out through APHL

B. cereus biovar anthracis

B. cereus B. anthracis B. cereus biovaranthracis

Hemolysis Beta Gamma (no hemolysis)

Gamma (no hemolysis)1

Motility Motile Non motile Motile2

1: Some strains can be weakly hemolytic after 48 h of incubation2: Most strains are motile. Goat strains from Democratic Republicof the Congo are non‐motile.


• Both B. anthracis and B. cereus biovaranthracis are non‐hemolytic– Ground glass colonies– Large GPRs– Catalase positive

• But the motility differs– So motility can no longer differentiate these organisms


• Issue: public health labs could be inundated by non‐hemolytic Bacillus isolates (common culture contaminants)

• Ensure clinical relevance of non‐hemolytic, large GPR, catalase‐positive isolate– Before sending to public health lab

New guideline: Biological Safety

• Laboratory response network• Lab risk assessment

– Identification of hazards– Evaluation and prioritization of risks– Risk mitigation strategies– Implement control measures– Review of risk assessment

Biological Safety

• Sentinel lab biological safety– Biosafety levels– Engineering and administrative controls; PPE– Exposure monitoring, vaccination– Disinfection of lab surfaces– Routes of agent transmission– Safe handling of clinical specimens

• Biosecurity• Biomedical waste management

Resources

Sentinel Level Clinical Laboratory Guidelines: https://www.asm.org/index.php/guidelines/sentinel‐guidelinesBiomedical waste management

ASM Listservs:https://www.asm.org/index.php/online‐community‐groups/listservs


ENGAGING THE WISCONSIN CLINICAL LABORATORY NETWORK (WCLN)Subtitle


Objectives

• Describe how Wisconsin PHL engages with clinical laboratories on training and biosafety issues

• Describe how information from the APHL biosafety survey is utilized by the state


Why Training?• 133 clinical labs and 2 public health

labs comprise the WCLN• These clinical lab partners form the

base of Wisconsin’s Laboratory Response Network (LRN)

• The Wisconsin State Laboratory of Hygiene (WSLH) is dependent on clinical laboratory data and patient samples for our surveillance programs– This is time consuming for clinical labs

and outside of their focus on patient care• Free training is one way we can give

back something of value that strengthens our relationships


Selection of Training Topics• Often collaborate with our Laboratory Technical

Advisory Group (LabTAG) – comprised of 1 member from each of 7 emergency response regions and 3 or more at large members representative of the WI clinical labs– Emerging situation– Directed messaging from another agency– Training needs assessment/survey– Suggestions from training event evaluations– Identified problem– Emerging technology

Emerging Situation

Identified Problem

Emerging Technology

HAN Alert

2017 Biosafety Risk Assessment Data Tabulated and Heat Mapped


2017 - Revised WCLN BiosafetyRisk Assessment (BRA) Tool84 of 147 (57.1%) laboratories completed the revised 2017 BRA tool in comparison to 112 of 150 (74.7%) in 2015.• Different labs completed in 2017 in comparison to 2015• At least 1 lab felt they did the BRA once in 2015 and

didn’t need to do it again.• Didn’t understand our training


Biosafety Risk Assessment/SurveyLaboratory Changes

in the Last Year(N=79)

*All of these impact risk and require the performance of a biosafety risk assessment


Biosafety Risk Assessment/SurveyLaboratory Biosafety Response

to Changes in the Last Year


Available Training Options

• Wisconsin Laboratory Messages• WCLN Listserv• Webinars• Technical Conferences/Workshops• Regional Meetings• Site Visits• Shared Template/Resource Material


Styles of Training

Use a variety of styles:• Lecture• Case studies or stories• Use of a polling tool such as “i-clicker”• Panel discussion• Moderated audience discussion• Games/competition such as “Kahoot!”• Small group discussions/assignments

Analysis.Answers.Action.

www.aphl.org

I am very aware of the risk category and associated biosafety risks for all microorganisms I knowingly and may unknowingly work with. Do you agree with this statement?

• Yes, I put on my biosafety risk assessment glasses daily when I enter the lab and think about all associated biosafety risks with every culture, test, and task I perform.

• I try, but I’m not completely sure what “risk category” and “associated biosafety risks” are for all the microorganisms I may work with.

• There is too much work to be done to think about risk categories and biosafety risk assessments unless it’s spelled out in our SOP’s.

• I expect my employer to define all biosafety risks related to my job and to take responsibility for preventing lab acquired infections (LAIs).

• C and D

Example of an I-Clicker Question


Training Suggestions from 2018 Wisconsin Clinical Laboratory Network Regional Meetings• Moderated audience discussion

– Smaller clinical labs still need help performing risk assessment especially to move it beyond microbiology into the other clinical diagnostic testing areas

– Template for what should be included in a laboratory biosafety plan

– Need tools or written guidance that lays out expectations of minimal levels of emergency preparedness expected of clinical laboratories to take to upper administration to justify time spent on emergency preparedness training and drills


What’s Next?• Waiting for results from the APHL “Biosafety

Practices and Needs in Clinical Laboratories Survey”– Launch Date: June 5, 2018– Closed September 30th

– Gather information on institutional biosafety practices; linkages with public health laboratories; and unmet biosafety needs

• Meeting with LabTAG to start planning for 2019 training events on November 6, 2018

There is Still Work to be done!

Captivating Collaborations – Working Together to Improve Public Health Response

Moe Sullivan

October 3, 2018

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Minnesota Laboratory System (MLS)

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An integrated network of public and private clinical laboratories working together

to protect and improve the health of all Minnesotans

History of MLS

• Started in 2001

• Funded by initial Bioterrorism Grant

• Network of labs needed in Minnesota

• Needed better customer service for our clinical laboratories

• Number of clinical laboratories and contact information was unknown

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In the Beginning…

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Phone survey (Complete)• Collected contact information for all MLS laboratories

• Created database for future MLS lab alerts

• Determine general capability and capacity

Comprehensive on-site survey• Determine comprehensive capability and capacity

• Promote personal interaction

• Encourage two-way dialogue

• Identify resource and training needs

MLS: Laboratory Survey

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Goals of the MLS

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• Enhance quality of microbiology practice

• Infectious disease outbreak detection

• Antimicrobial susceptibility surveillance

• “Every-day” disease detection

• Improve Emergency Readiness• Bioterrorism (BT)

• Chemical terrorism

• Influenza (pandemic and seasonal)

• Other public health emergencies

• Biosafety

Coordination is Critical

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Identify and Respond to Public Health

Threats

Clinical/ Private Labs Public Labs

Interdependent Network

Diagnostic Testing

Some Reference Testing

Medical management

Focus = Individual health

Some Diagnostic Testing

Reference Testing

Surveillance and

Monitoring

Focus = Public health

Laboratory Response Network (LRN)

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Communication

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• MLS Lab Alert

• Google Groups –[email protected]

• www.health.state.mn.us/mls

• FIRST ALERT! September 11, 2001

• Broadcast FAX, if no E-mail

MLS Alerts

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MLS Educational Resources

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Educational Resources• Challenge Set

• Poster

• CLSI Guidelines

• In-person trainings:

• LRN Sentinel Lab BT Wet Workshops

• Regional Conferences

• Audio conference series

• Virtual conferences

• eLearning (web-based)

0

20

40

60

80

100

120

140

160

180

2002 (1) 2003 (11) 2004 (4) 2006 (3) 2008 (5) 2010 (2) 2011 (3) 2013 (3) 2015 (2) 2017 (3) 2018 (2)

Sentinel Lab Wet Workshops

Number of participants Number of facilities

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• MLS Challenge Set– Once yearly (going on year 17)

– 4 organisms/set (lyophilized at MDH)

– Selection of organisms

• Public health importance (GBS, foodborne path, etc.)

• Important or emerging antibiotic susceptibility test issues (D-test, KPC, etc.)

• BT agents and surrogates

– Notification by sentinel labs - if appropriate; documented

– Shipping of isolate back to MDH to evaluate packaging

Challenge Set

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• MLS Challenge Set (cont.)– Mini-survey for each organism

(collaborate with Epi to develop)

– Robust report provided – emphasize important issues and gaps

– Allows for understanding of gaps

– Excellent participation >90% every year

– Excellent feedback – learning tool

Challenge Set

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Did not perform culture6%

Satisfactory‐Can not rule out B. anthracis (referred to MDH‐…

Satisfactory‐Ruled out B. anthracis

correctly6%

Unsatisfactory‐Ruled out B. anthracis incorrectly…

Unsatisfactory‐Can not rule out B. anthracis (not referred to …

Challenge Exercise 2002Ability to rule out B. anthracis and Refer to MDH‐PHL

(n=126)

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Satisfactory‐Can not rule out B. anthracis (referred to MDH‐PHL)…

Satisfactory‐Ruled out B. anthracis correctly…

Unsatisfactory‐Ruled out B. anthracis incorrectly…

Unsatisfactory‐Can not rule out B. anthracis (not referred to MDH‐PHL)…

Challenge Exercise 2016Ability to rule out B. anthracis and Refer to MDH‐PHL

(n=77)

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Satisfactory‐Can not rule out Brucella spp. (referred to MDH‐…

Satisfactory‐Ruled out Brucella sp. correctly…

Unsatisfactory‐Ruled out Brucella spp. incorrectly…

Unsatisfactory‐Can not rule out Brucella spp. (not referred to MDH‐PHL)…

Challenge Exercise 2002Ability to rule out Brucella spp. and Refer to MDH‐PHL

(n=126)

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Did not perform culture…

Satisfactory‐Can not rule out Brucella spp. …

Satisfactory‐Ruled out Brucella sp. …

Unsatisfactory‐Ruled out Brucella spp. …

Unsatisfactory‐Can not rule out Brucella spp. (not …

Challenge Exercise 2017Ability to rule out Brucella spp. and Refer to MDH‐PHL

(n=68)

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• Added bonuses: non-BT issues– Builds relationships for other surveillance

• Influenza

• Reportable diseases

• Other emerging issues (i.e. CRE)

– Helps in collaboration with epidemiology and their surveillance programs

– Builds the Laboratory System

Challenge Set

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Current MLS Sentinel Laboratories

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Biosafety Outreach

• Baseline survey

• Contact information for Biosafety officer

• Audioconferences

• Regional conferences• Year 1: basic biosafety, biosecurity and risk assessments

• Year 2: biosafety and infection control (combined conference) with tabletop exercise

• Ongoing collaboration with Ebola assessment and treatment hospitals

• Site visits and consultation

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• Creation of Minnesota Laboratory System has been key to ongoing collaboration, outreach and training with Sentinel laboratories

• Creating a network for improving quality microbiology practices has been extremely valuable

• Challenges include staffing in clinical laboratories and emphasis on microbiology laboratories

• Landscape of MLS is changing in numbers and technology

Summary

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Thank you!

Moe [email protected]

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Questions?


Thank You For Participating

Please direct all further questions to Sam Abrams at [email protected] or 240-485-2731.

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