2015 APHL Annual Meeting Indianapolis, IN

Poster Abstracts

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Florida Bureau of Public Health Laboratories' Statewide CLIA Training on Personnel Competency Assessment R. Remo1, M-C. Rowlinson1, S. Crowe2; 1Bureau of Public Health Laboratories, Florida Department of Health, Jacksonville, FL, 2Florida Department of Health, Jacksonville, FL Introduction: In November 2012, the U.S. Centers for Medicare and Medicaid Services (CMS) published a new guidance regarding the requirements for personnel competency assessment (CA) to be in compliance with federal regulation. The Clinical Laboratory Improvement Amendments (CLIA) regulation for CA applies to all testing personnel but the new guidance highlights, who needs to be assessed and when, who is qualified to perform the assessment and the six minimum required procedures to be followed as part of an assessment. The Bureau of Public Health Laboratories (BPHL) developed training materials to assist laboratories throughout Florida in meeting the requirements. Methods: BPHL developed a 2-hour training that provided information on the new guidance, instruction on how it applies in various settings, and templates/tools that participants can use in their own laboratories to improve their procedures. BPHL utilized a sentinel laboratory database (developed as part of its preparedness efforts) to reach laboratories throughout Florida and advertise the training. The in-person training was scheduled at four geographically distinct locations in the state: Jacksonville, Miami, Pensacola and Tampa. Two sessions per location were scheduled with a maximum of 30 participants; BPHL staff also had the opportunity to attend. Participants were eligible to earn 2.0 continuing education credits. Results: BPHL developed standardized templates and tools for performing and documenting CA in compliance with regulation. Over the past year, BPHL has been rolling out standardized CA at the BPHL laboratories utilizing the templates. In addition, BPHL has been implementing a centralized system for documenting CA and other personnel related information. BPHL developed a CA training utilizing these and other materials. Conclusion: BPHL has improved its CA process and has standardized methods for performing assessments and documenting information. The BPHL-developed CA training is assisting public health and clinical laboratories in Florida in meeting CLIA requirements. Furthermore, the training is providing an opportunity for the public health laboratory to further develop its relationship with the sentinel clinical laboratories and is a model for a continued effort to share best practices."

Presenter: Radley Remo, MPH, Quality Assurance, Bureau of Public Health Laboratories, Division of Disease Control and Health Protection, Florida Department of Health, 1217 Pearl Street, Jacksonville, FL 32202, Phone: 904.791.1518, Email: Radley.Remo@flhealth.gov

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Implementing Ebola Testing: Rollout at the Bureau of Public Health Laboratories in Miami C. Monroy, S. White and L. Gillis, Florida Department of Health, Miami, FL The Ebola Zaire virus is a causative pathogen of Ebola Virus Disease (EVD), a hemorrhagic fever with a mortality rate of 32 - 88%. In March of 2014, an outbreak of the Zaire strain occurred in Guinea and spread to Liberia and Sierra Leone. The rapid spread of this outbreak, coupled with the high number of airline flights from affected areas to the United States (US), prompted the US Centers for Disease Control and Prevention (CDC) to deploy an assay for the detection of EVD cases. In August 2014, the CDC requested 13 laboratories within the Laboratory Response Network to participate in the initial deployment of the assay, including the Bureau of Public Health Laboratories (BPHL)-Miami. The preparedness staff met daily to define tasks required to accommodate the assay. These included augmenting the Biosafety and Biosecurity Plans, developing submission guidelines, and communicating with our testing partners. The worsening condition in West Africa, coupled with increasing public concern, led the Florida Department of Health (FDOH) to create an EVD incident management team (IMT) in October. The FDOH IMT’s objectives were to prepare the Florida, focusing on identification, testing, and containment. Through the IMT, the laboratory was able to distribute supplies throughout Florida to ensure that proper packaging and shipping occurred for suspected EVD cases. The resulting process developed by the BPHL-Miami, from sample collection to testing, provided a streamlined workflow for suspected EVD cases. BPHL-Miami began accepting specimens within 2 weeks of the CDC request. Integration of the laboratory into the IMT structure assisted in the development of procedures, assistance in hospital and health department staff training, and the distribution of critical supplies. This rapid development and deployment of emergency testing will serve as a model for public health laboratories encountering emerging public health threats. Presenter: Carlos Monroy, PhD, MT (AAB), Bioterrorism Defense Coordinator, Bureau of Public Health Laboratories – Miami, Division of Disease Control and Health Protection , Florida Department of Health, 1325 NW 14th Ave, Miami, Florida 33125, Phone: 305.325.2537, Email: carlos.monroy@flhealth.gov

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100 Year Celebration: A Model for Public Health Outreach C. Monroy, E. Quaye, J. Kersaint and L. Gillis, Florida Department of Health, Miami, FL In 1914, the State Board of Health, now the Florida Department of Health (FDOH), established the State Public Health Laboratory in Miami. The laboratory in Miami, now the Bureau of Public Health Laboratories (BPHL)–Miami, originally established to provide diagnostic screening to the State Board of Health and private physicians has evolved through the years, as hospital and commercial laboratories were created and disease challenges changed. A commemorative event was planned to celebrate 100 years of service. We formed a workgroup and decided to use the celebration as an opportunity for community outreach. Planning of the event required organizing several subcommittees and tasking personnel with the challenge of discovering the history of the laboratory. Staff searched through archives and found the original 1914 announcement of the laboratory’s opening. The 100 Year Anniversary workgroup developed a workflow timeline to cover all aspects of the commemoration. Subcommittee goals included sending invitations to key public figures and other partners, preparing display materials, developing the programming, and catering. A key component in reaching out to the public was the development of posters by each BPHL-Miami department, detailing work performed and other informative data. Subcommittee chairpersons met regularly to ensure completion of tasks. As the event date approached, partnerships were developed with FDOH in Miami-Dade County and the FDOH Office of Communications, and both became important collaborators, as these partnerships allowed for outreach through a health fair and a web-accessible video. For the day of the event, a health fair, a formal program with invited speakers, and guided tours of BPHL-Miami were provided. The posters ensured knowledge of the public health laboratory’s role in combating emerging and current public health threats were highlighted. Extensive planning, teamwork, and collaboration resulted in a successful 100 year celebration. Presenter: Leah D. Gillis, MS, PhD, HCLD(ABB), Laboratory Director, Bureau of Public Health Laboratories - Miami , Division of Disease Control and Health Protection, Florida Department of Health, 1325 NW 14th Avenue, Miami, Florida 33125-1759, Phone: 305.325.2533, E-mail: Leah.Gillis@flhealth.gov

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Update: Miami Public Health Laboratory as a Regional Confirmatory Test Site for the National HIV Behavioral Surveillance (NHBS) System L. Gillis1, B. Luna1, B. Bennett2; 1Florida Department of Health, Miami, FL, 2Bureau of Public Health Laboratories, Jacksonville, FL

Objective: To continue support of the NHBS system by the Florida Department of Health’s (FDOH) Bureau of Public Health Laboratories (BPHL)-Miami, through the expansion of HIV-1 supplemental testing services from two to five NHBS sites. Expansion: In 2012, the FDOH BPHL-Miami was designated as a regional HIV-1 supplemental testing laboratory for public health programs and labs participating in Florida and Louisiana NHBS. The CDC created NHBS in 2003 to conduct behavioral surveillance among persons at high risk for HIV infection. NHBS is a multi-year surveillance study conducted in 20 jurisdictions with high AIDS prevalence. Due to advances in HIV1/2 diagnostic testing, some of the labs that provide test services for these areas no longer perform oral fluid or blood-based Western blots (WB), thus, leaving NHBS participants with limited options for supplemental HIV testing. Since the Miami laboratory had been providing supplemental testing on dried blood spots (DBS) for NHBS in Florida, the CDC requested that BPHL-Miami provide DBS supplemental testing for other sites, in order to support continued surveillance activities. In 2014 supplemental testing expanded from Florida (Miami) and Louisiana (New Orleans) to include Texas (Dallas), Pennsylvania (Philadelphia), and Massachusetts (Boston) NHBS sites. Three different reporting methods (pick-up at lab, computerized data transfer, and courier delivery) were developed and implemented. Results: Memorandum of Understandings (MOUs) between FDOH BPHL-Miami and the additional three NHBS sites were completed. The increase of testing sites from 2 to 5 resulted in a 14.38 fold increase (62 vs. 892) in the number of samples tested. Overall, the FDOH BPHPL-Miami performed supplemental testing for 25% of the NHBS enrolled sites. Conclusions: The FDOH BPHL-Miami implementation of DBS supplemental testing for the NHBS system in 2012 has resulted in an increase in 2014 testing services, demonstrating a successful regionalization testing concept. The FDOH BPHL-Miami expansion of supplemental testing services for NHBS continues to fulfill the CDC and the Association of Public Health Laboratories (APHL) co-sponsored Laboratory Efficiencies Initiative (LEI) which encourages the regionalization of testing services to build a sustainable public health laboratory system. Presenter: Leah D. Gillis, MS, PhD, HCLD(ABB), Laboratory Director, Bureau of Public Health Laboratories - Miami , Division of Disease Control and Health Protection, Florida Department of Health, 1325 NW 14th Avenue, Miami, Florida 33125-1759, Phone: 305.325.2533, E-mail: Leah.Gillis@flhealth.gov

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Marketing Public Health Lab Careers to Middle School Students Through Educators A. Cosser1, A. Fritzinger2, D. Gibson3, T. Hayden4, P. Held5, K. Hsieh6, S. Humphries7, C. Leaumont4,

D. Lopez8, S. Marine9, Bernadette Mathis10, K. Musser11, H. Patel12, M. Ritchie13, L. Simpson14, S. Vetter15, H. Roney16, L. Siegel16; 1New Hampshire Public Health Laboratories, Concord, NH, 2Virginia Division of Consolidated Laboratories, Richmond, VA, 3Montana Public Health Laboratory, Helena, MT, 4Centers for Disease Control and Prevention, Atlanta, GA, 5Wisconsin State Laboratory of Hygiene, University of Wisconsin-Madison, Madison, WI, 6California

Department of Public Health, Richmond, CA, 7Florida Department of Agriculture and Consumer Services, Tallahassee, FL, 8Tulare County Laboratories, Tulare, CA, 9Iowa State Hygienic Laboratory, Coralville, IA, 10Philadelphia Public Health Laboratory, Philadelphia, PA, 11Wadsworth Center, New York State Department of Health, Albany, NY, 12North Carolina State Department of Public Health, Raleigh, NC, 13Florida Bureau of Public Health Laboratories, Jacksonville, FL, 14Texas Department of State Health Services, Austin, TX, 15Minnesota Department of Health, St. Paul, MN, 16Association of Public Health Laboratories, Silver Spring, MD The current Public Health Laboratory (PHL) system faces a critical workforce shortage. This shortage is expected to worsen in the near future as the existing workforce retires and there are limited opportunities for students to become aware of and choose careers in PHL science. To address this situation, the Association of Public Health Laboratories’ Emerging Leader Cohort 7 group are leveraging existing PHL educational materials and resources and developing a comprehensive marketing plan to reach middle school students through teachers and educators. Our objectives are to educate middle school students about PHL science and careers by providing teachers access to multi-media resources about PHL science that are high quality, readily available, and age appropriate. We will also develop new resource material to supplement existing material. To achieve this, we are developing a marketing plan which includes surveying teachers to find out how we can reach them most efficiently and effectively with these educational materials. This plan will also encompass lessons learned by other groups who have already done outreach work to the same audience, a two tiered roll-out (electronic and grass-roots), and a blog competition focusing on public health lab science for middle school classrooms to enter. Results will be assessed on the basis of successful distribution and utilization; e.g., how effectively do the materials reach the intended audience, and how likely are they to be utilized to inform students about Public Health Lab careers. Presenter: Sherri Marine, Client Services Manager, State Hygienic Laboratory at the University of Iowa, 2490 Crosspark Road, Coralville, IA 52241, Phone: 319.335.4260, Email: sherri-marine@uiowa.edu

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Experience of the Nebraska Public Health Laboratory in Response to theEbola Virus Public Health Emergency V. Herrera1, A. Sambol1, P. Iwen1,2; 1Nebraska Public Health Laboratory, Omaha, NE, 2University of Nebraska Medical Center, Omaha, NE Background: On 1September 2014 the Nebraska Public Health Laboratory (NPHL) received notice to prepare for the possible transfer of a patient with Ebola virus disease (EVD) from West Africa to the Nebraska Biocontainment Unit (NBU). Since inception of the NBU, the Special Pathogens Branch of the NPHL had an agreement to coordinate laboratory testing of specimens for patients admitted to this unit. This report describes some of the challenges encountered as

we became the first state public health laboratory (PHL) in the US to provide laboratory support for a patient with EVD. Methods: Prior to arrival of our first patient, a risk assessment team was formed, compromised of NPHL staff, hospital leadership, physicians, and other medical and laboratory staff. The role of this team was to define the essential laboratory tests that might be needed to care for the patient, to determine which tests could be performed safety in the laboratory, to provide alternative tests for those that could not be performed safely, and to determine how the laboratories on campus could be integrated into the testing process. Results: The risk assessment team devised a list of essential tests that could be performed safely in the laboratories available and provided alternative testing for those that could not be performed safely. In the assessment process a laboratory within the NBU was developed to be used for point-of-care testing and initial processing of specimens, the hospital core laboratory was recognized to provide closed-tube testing on automated chemistry, hematology, and immunoassay analyzers for some of the essential tests; and the BSL-3 laboratory at the NPHL was identified to provide for molecular testing, other infectious diseases testing, and storage of clinical specimens for future studies and shipping. Conclusions: Our experiences showed the necessity of being flexible to the requests of the medical staff and the need to maintain direct lines of communication to prepare and care for a patient with EVD. Since most medical facilities in the US do not have direct access to a PHL, our experiences also showed the importance for PHL personnel to develop open lines of communication with other laboratory partners within their jurisdiction which will be critical for the management of a patient with or under investigation for EVD. Presenter: Peter C. Iwen, MS, PhD, D(ABMM) , Director, Nebraska Public Health Laboratory, University of Nebraska Medical Center, 985900 Nebraska Medical Center, Omaha, Nebraska 68198-5900, Phone: 402.559.7774, E-mail: piwen@unmc.edu

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Transportation of Ebola Virus-Infected Specimens: A Public Health Laboratory's Experience K. Stiles, A. Sambol and P. Iwen, Nebraska Public Health Laboratory, Omaha, NE Introduction: The Nebraska Public Health Laboratory (NPHL) became the first state public health laboratory in the U.S. to intentionally transport known Ebola virus (EV) infected specimens. This study provides an overview of the experiences learned in the development of methods for the transportation of specimens containing or potentially containing EV. Hypothesis: Movement of specimens known or with the potential to contain EV whether in-house or by intrastate/interstate processes requires extensive training in not only the physical handling of the package, but also in adherence to the requirements as described by the federal agencies regulating transport of dangerous goods. Results: A review of potential shippers and couriers within our state that might transport specimens known or with the potential to contain EV showed a lack of certification as required by the Department of Transportation (DOT) Hazardous Materials Regulations (HMR: 49 CFR

Parts 121-180). The recognition that these specimens are categorized by the DOT as Category A infectious substances necessitated the development of training activities and protocols based on the different scenarios that might occur, such as if EV was present or not in the specimen, the courier system needed to transport, and where the specimen was being transported too. Communication with individuals at the DOT, the NE DHHS Public Health Emergency Preparedness Division, FedEx Dangerous Goods Division and the APHL was essential to develop strategies to transport these specimens. Classification, packaging and labeling requirements, mode of transport and security awareness, all had an effect on the transportation process. Conclusions: The review of processes in place along with the collaborative efforts of many individuals provided the resources and strategies needed to develop templates for the transport of EV-infected or potentially infected specimens via appropriate carriers for testing. Each stage in the evaluation process, from collection to actual testing, was carefully considered, to ensure the highest level of security and safety for the specimen transported. This activity has provided NPHL with an all-hazards approach for future use, to include transportation of specimens with the potential to contain not only EV but any other highly infectious agent. Presenter: Peter C. Iwen, MS, PhD, D(ABMM) , Director, Nebraska Public Health Laboratory, University of Nebraska Medical Center, 985900 Nebraska Medical Center, Omaha, Nebraska 68198-5900, Phone: 402.559.7774, E-mail: piwen@unmc.edu

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Validation and Performance of an Algorithm for the Detection of Carbapenemase-Producing Enterobacteriaceae T. Southern1, A. Brockman1, S. Buss2, C. Carlson3, C. Murphy1, P. Fey4, P. Iwen1; 1Nebraska Public Health Laboratory, Omaha, NE, 2Wyoming Public Health Laboratory, Cheyenne, WY, 3South Dakota Public Health Laboratory, Pierre, SD, 4University of Nebraska Medical Center, Omaha, NE Introduction: Carbapenemases are enzymes that inactivate beta-lactam antibiotics including the carbapenems, a group of antibiotics critical for the treatment of severe or multidrug-resistant bacterial infections. Carbapenemase-producing gram negative bacteria are endemic in many countries and are identified with increasing frequency in the US. This study describes the validation of an algorithm for the detection of carbapenemase-producing Enterobacteriaceae (CPE) and provides a prospective analysis of carbapenem-non-susceptible isolates from clinical specimens. Methods: Reference isolates from the Nebraska Public Health Laboratory, the South Dakota Public Health Laboratory and the Centers for Disease Control and Prevention (CDC) were used for assay validation. Isolates included 24 positive for Klebsiella pneumoniae carbapenemase (blaKPC), 6 positive for New Delhi metallo-beta-lactamase-1 (blaNDM-1), and 8 negative for both enzymes. Additionally, 39 Enterobacteriaceae isolates non-susceptible to one or more carbapenems according to MicroScan (Siemens) were prospectively tested using the

algorithm. All isolates were tested by the Modified Hodge test (MHT), chromID CARBA agar (bioMerieux), the KPC+MBL Confirm ID Kit (Rosco Diagnostica), and a laboratory developed real time polymerase chain reaction (RT-PCR) assay. The MHT was performed according to CLSI standards, chromID agar and the Confirm ID kit were used according to manufacturer instructions, and the RT-PCR assay was performed using CDC methods. Results: The sensitivity and specificity of the assays for carbapenemase detection using reference isolates were: 91.7% and 71.4% for the MHT; 100% and 100% for the chromID agar, Confirm ID kit and RT-PCR. Prospective analysis of the carbapenem-non-susceptible clinical isolates resulted in the detection of 2 Klebsiella oxytoca positive for blaKPC. Specificity for blaKPC detection from clinical isolates was 90.2% for the MHT, 97.3% for the Confirm ID kit and 100% for the chromID agar and RT-PCR. Conclusions: These results showed that the chromID agar, Confirm ID kit and the RT-PCR assay provided reliable results for the detection of CPE. Future efforts will focus on additional testing to further assess algorithm performance and to evaluate the frequency and distribution of CPE in Nebraska. Presenter: Timothy R. Southern, PhD, Nebraska Public Health Laboratory, University of Nebraska Medical Center, 985900 Nebraska Medical Center, Omaha, Nebraska 68198-5900, E-mail: robbie.southern@unmc.edu

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LRN-C Activities as the Foundation for a Laboratory Technical Center P. Moyer, Minnesota Department of Health, St Paul, MN For more than a decade the Laboratory Response Network for Chemical Threats (LRN-C) has provided emergency response capabilities for state and local areas, and the nation. These resources, as supported by the Public Health Emergency Preparedness cooperative agreement, help state laboratories prepare for and respond to incidents involving the release of harmful chemicals. Over time the LRN-C activities have provided many states the opportunity to branch out beyond the priority capabilities outlined in the cooperative agreement and programmatic guidelines to contribute other benefits to their state and local public health programs. This additional programmatic support may take the form of providing technology and instrumental capabilities through the “full use” approach of utilizing LRN-C instruments for secondary analyses when not being run for the LRN-C priority work. Also, the expertise and experience of the LRN-C chemists are available to consult on other lab related matters and to inform scientific decisions regarding new projects or proposals. Many states are successfully leveraging the resources provided by the LRN-C to help support and achieve public health goals within their jurisdiction. Capitalizing on this trend, the state of Minnesota has developed a technical center within the laboratory with LRN-C supported staff at its core that provides the foundation for advancing laboratory activities. Formed in 2014, the Biomonitoring and Emerging Contaminant Unit

supports many state public health programs that require analytical support or otherwise benefit from laboratorian expertise. These efforts include partnering on state specific biomonitoring projects for example analyzing mercury levels in newborns, expanded outreach to the first responder community, and method development and sample analyses for contaminants of emerging concern in drinking water sources. In addition, converging technology such as mass spectrometry within the Newborn Screening, Environmental, and Infectious Disease Laboratory Sections may be most successfully integrated with the help of a core group of experts available to ensure the best use of these resources. While many benefits of this approach of using LRN-C activities to the fullest extent can be cited, several challenges also must be considered and addressed. Presenter: Paul Moyer, MS, Manager, Environmental Laboratory, Public Health Laboratory Division, Minnesota Department of Health, 601 Robert St. North, PO Box 64899, St. Paul, MN 55164-0899, Phone: 651.201.5669, Email: paul.moyer@state.mn.us

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Keeping the Cameras Pointed Away from the Lab During Ebola Virus Testing S. Hughes, E. Wilson, C. Da Costa-Carter, B. Deocharan and J. Rakeman, New York City Public Health Laboratory, New York, NY The New York City Department of Health and Mental Hygiene (DOHMH) Public Health Laboratory (NYC PHL) is directly across the street from a hospital designated to treat patients under investigation for Ebola virus infection. Soon after notification that the hospital would receive their first patient suspected of being infected with Ebola virus, the news vans arrived with reports to the world being delivered from the doorstep of the NYC PHL. Keeping the cameras focused on the patient and not the laboratory was a result of pre-planning and inter-agency coordination. Weeks before the first patient arrived in New York City, the NYC PHL had been working closely with the CDC, APHL and other LRN laboratories to implement a single target real-time reverse transcription PCR assay that had been developed by the Department of Defense and issued under an emergency use authorization granted by the FDA. Introduction of Ebola virus testing required introduction of new protocols and precautions to handle specimens potentially infected with a virus long classified as a BSL4 agent. Risk assessments were developed in conjunction with APHL and several process steps were identified that could lead to accidental exposures. In light of the known and unknown risks associated with handling Ebola virus specimens it was determined that all processing activities including nucleic acid amplification should be overseen by a safety officer and performed in a BSL3 facility. Specimen handling logs were also developed to document all staff involved with handling and processing potential Ebola virus specimens. Staffing schedules for training and testing were developed to ensure that well trained testing teams would be available at any time of the week. In addition to preparations within the testing lab, guidance on handling Ebola virus specimens for transport to NYC PHL and shipping to CDC was developed in conjunction with outreach that was

conducted with designated partner hospitals to review and walk thru the process of collecting, packaging and handing off specimens to NYC PHL staff. With these measures in place, NYC PHL was able to rapidly test and report, in less than 3 hours after specimen collection, a positive result for Ebola virus. We were also required to package and ship, on a near daily basis, Ebola virus specimens to CDC. The laboratory continues to refine all phases of Ebola virus specimen handling and testing. Presenter: Scott Hughes, PhD, Associate Director, Environmental Sciences, Public Health Laboratory, New York City Department of Health and Mental Hygiene, 455 First Avenue, New York City, NY 10016, Phone: 212.447.6121, Email: shughes@health.nyc.gov

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Real-time 4th Generation HIV Algorithm Implementation in the STD Clinic at the City of Milwaukee Health Department S. Gradus1, J. Navidad1, M. Khubbar1, K. Krchnavek2, W. Genous1, E. Osuala1, W. Borzon1, I. Reitl1, K. Owusu-Ofori1, S. Bhattacharyya1; 1City of Milwaukee Health Department Laboratory, Milwaukee, WI, 2Wisconsin Department of Health Services Wisconsin State Laboratory of Hygiene, Madison, WI Introduction: The City of Milwaukee Health Department Laboratory and STD Clinic, with the support of the Wisconsin State Department of Health Services HIV program, is implementing 4th generation AIDS/HIV testing per the CDC algorithm in a clinic setting to provide near-real-time results and onsite confirmatory testing and counseling to patients prior to their departure from the clinic. Methods: The 4th Generation HIV Antigen/Antibody chemiluminescent microparticle immunoassay on the Architect platform (Abbott Laboratories, Abbott Park, IL) is used to screen blood samples for HIV p24 antigen and HIV 1/2 antibodies from suspect patients visiting the clinic. Positive reactive samples are followed by MultiSpot confirmatory assay (Bio-Rad, Hercules, CA) which differentiates HIV 1 & 2 antibodies. Any inconclusive results are sent for HIV 1-Proviral DNA PCR testing to the Wisconsin State Laboratory of Hygiene. LEAN tools were used to analyze and improve clinic workflow to minimize the impact on patient wait time. Results: A major paradigm shift to real-time testing and confirmation of HIV using the 4th Generation algorithm in a clinic setting, rather than utilizing the Architect instrument as a follow-up reference test, allows patients to be tested and counseled, in most cases, prior to departing the clinic. LEAN analysis of workflow allowed process improvements that have decreased wait-time for clients. Conclusion: We are demonstrating that the 4th Generation HIV testing algorithm can be implemented in a public health clinic setting for real-time screening and confirmation and counseling for clients on the same day of their visit to the clinic. This practice will mostly eliminate less sensitive manual rapid-screen tests, enhancing the local public health system’s capacity for early HIV case detection thus improving HIV and AIDS case management in Milwaukee and Wisconsin.

Presenter: Steve Gradus, Laboratory Director, City of Milwaukee Health Department, 841 N. Broadway, Room 205, Milwaukee, WI 53202, Phone: 414.286.3526, Email: sgradu@milwaukee.gov

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Metagenomic Analysis of Human Fecal Microbiome Using Ion Torrent 16S rRNA Sequencing to Understand Microbial Diversity and Pathogen Association with Diarrheal Disease Outbreaks in the United States S. Bhattacharyya1, M. Sanchez-Gonzalez2, C. Liddiard3, J. Navidad1, A. Patel4, M. McDermott5, R. Groepper6, David Warshauer7, L. DesJardin6, S. Gradus1, Daria Salyakina8, J. Coffman2; 1City of Milwaukee Health Department Laboratory, Milwaukee, WI, 2Larkin Health Sciences Institute, South Miami, FL, 3Milwaukee School of Engineering, Milwaukee, WI, 4LeBonheur Children's Hospital, Memphis, TN, 5Oklahoma State Department Health, Oklahoma City, OK, 6State Hygienic Laboratory University of Iowa, Coralville, IA, 7Wisconsin State Laboratory of Hygiene, Madison, WI, 8Center for Computational Science, Coral Gables, FL Introduction: Human fecal pollution provides a reservoir for food and waterborne disease agents and contributes to significant morbidity and mortality worldwide. Distribution of 16S rRNA gene sequences in fecal sample represents the state-of-the-art for determination of human gut microbiota composition. The goal of this study was to identify and characterize gut microbiome in fecal samples from symptomatic and non-symptomatic subjects using Next Generation Sequencing (NGS) of 16S rRNA regions. Materials and Methods: A total of 59 de-identified, human stool samples with signs and symptoms of gastrointestinal (GI) illness were collected from 5 geographic sites. Nucleic acid was extracted from frozen stool on easyMAG instrument (BioMérieux, NC) and screened for GI pathogens using culture, real-time PCR and xTAG gastrointestinal pathogen panel (GPP) (Luminex Corporation, TX). 16S rRNA gene sequencing was performed on Ion Torrent platform (Life Technologies, CA), followed by bioinformatics and statistical analysis using SPSS version 21.0 (IBM, IL). Results: Ion Torrent Sequencing of 16S rRNA confirmed bacterial pathogens detected by GPP assay and also identified potential causal bacterial species associated with human diseases. The rarefaction curve analysis showed 203 different species. Student’s t tests demonstrated significant (p < 0.05) gender differences such that Butyricimonas and Lactatifermentans were higher in females compared to males, those found to be associated with anti-inflammation properties and dairy consumption. ANOVA analysis demonstrated a significant (p < 0.01) correlation. Interestingly, Verrucimicrobiales species was higher (P < 0.05) in Wisconsin (~25%) specimens compared to the other sites. Conclusion: Metagenomic analysis of human fecal microbiome using 16S rRNA sequencing has allowed understanding of bacterial diversity and distribution of microbial pathogens. Future studies on the association among bacterial populations could provide insight into host-pathogen dynamics and interactions, including diarrheal disease outbreaks, population health

risks, antibiotic resistance patterns, and improved characterization for fecal transplant screening impacting both individual patient management practices and public health intervention strategies. Presenter: Sanjib Bhattacharyya, PhD, Deputy Laboratory Director, City of Milwaukee Health Department, 841 N. Broadway, Room 205, Milwaukee, WI 53202, Phone: 414.286.5702, Email: sbhatt@milwaukee.gov

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Growing Healthy Soil for Healthy Communities- A Community, Academic, Public Health Partnership to Build Soil Testing Capacity D. Qadah1, K. Smith1, B. Hui1, R. Colla1, Lisa Lien1, S. Johnson3, C. Hamilton4, N. Gilliam5, J. Davis5, M. Martin6, D. Cardona6, B. Gramling6, D. Soldat7, G. Siemering7, S. Ventura7, S. Gradus1, S. Bhattacharyya1; 1City of Milwaukee Health Department, Milwaukee, WI, 2University of Wisconsin- Milwaukee, Milwaukee, WI, 3Medical College of Wisconsin, Milwaukee, WI, 4Medical College of Wisconsin, Milwaukee, WI, 5Walnut Way Conservation Corp., Milwaukee, WI, 6Sixteenth Street Community Health Centers, Milwaukee, WI, 7University of Wisconsin-Madison, Madison, WI, Introduction: Childhood lead poisoning remains a serious public health problem. Increased participation in urban gardening as a result of local food movements is likely to increase exposure risk from impacted soil. Community residents would benefit from increased access to soil testing for informed decisions on the risks and benefits of urban residential gardening. Large scale soil testing for lead and nutrient would likely be relevant to understanding bioavailability of lead which is not traditionally available to the local communities. Methods: The Mehlich 3 method of soil and nutrient testing was identified as a potential tool to enhance public health laboratory capacity to collaboratively address community-identified priorities. Proving the efficacy of the Mehlich 3 method would increase improved sample analysis and lower costs for gardeners. The correlation between total lead and Mehlich 3 extractable lead will be studied and soil nutrient levels used to calculate soil amendment rates to enhance lead sequestration. Results: Academic soil scientists, public health laboratorians and community-based organization with expertise in urban agriculture and environmental health collaboratively developed new capacity to utilize the Mehlich 3 method. One hundred properties, located in two neighborhoods where urban backyard gardening is actively promoted will undergo soil testing using Mehlich 3 methods in the next three years. Correlation between total soil lead concentrations will be determined using acid digestion with nitric and hydrofluoric acids per EPA Method 3052 and the Mehlich 3 method. Conclusion: Determining the efficacy of the Mehlich 3 method for soil nutrient and bioavailable lead analysis will be highly beneficial for cost-effective analysis and design effective interventions to mitigate those hazards. Long term goals are to increase community-based capacity for soil testing. Novel partnerships between academic, community-based

organizations, and public health laboratories will have the potential result in long term sustainable health improvement. Presenter: Sanjib Bhattacharyya, PhD, Deputy Laboratory Director, City of Milwaukee Health Department, 841 N. Broadway, Room 205, Milwaukee, WI 53202, Phone: 414.286.5702, Email: sbhatt@milwaukee.gov

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Laboratory Response Network - Chemical (LRN-C) Level 3 Resource Handbook K. Beeman1, E. Clark2, N. Gethin3, J. Jenner3, D. Krier4, P. Moyer4, S. Saravia4, T. Miller5, B. Van Ausdall6, B. Wemple7, D. White8, J. Rowland9; 1Oklahoma State Public Health Laboratory, Oklahoma City, OK, 2Workgroup Contributor, 3Massachusetts Department of Public Health, Jamaica Plain, MA, 4Minnesota Department of Health, 5Michigan Department of Community Health, Lansing, MI, 6Utah Public Health Laboratory, Taylorsville, UT, 7Vermont Department of Health, Burlington, VT, 8Mississippi Public Health Laboratory, Jackson, MS, 9Association of Public Health Laboratories, Silver Spring, MD The APHL Chemical Threat Collaborative Workgroup (CT-CWG), in conjunction with state public health laboratories, has developed the Laboratory Response Network for Chemical Threat (LRN-C) Level 3 Resource Handbook. This guide was designed to be used by LRN-C partners and in particular, LRN-C Coordinators who provide Level 3 outreach and training to hospital clinicians, laboratorians, first responders and personnel of other agencies that would respond to an accidental or intentional chemical release resulting in human exposure. The LRN-C is a three-tiered system that provides testing of clinical specimens collected from individuals who may have been exposed to chemical warfare agents or toxic industrial compounds that are not routinely identified by healthcare-based laboratories. Each LRN-C member laboratory also has Level 3 capabilities, including expertise in clinical specimen collection, storage, and packaging and shipping. There are several specific benchmark tasks designated by the Centers for Disease Control and Prevention (CDC) that are tied directly to funding, and every state should be able to perform these tasks. In addition to laboratory testing, Level 3 capabilities must include the provision of preparedness measures to be used by healthcare partners to respond to public health emergencies such as chemical threats. Many LRN-C member laboratories have developed robust Level 3 programs that include training, exercises, and outreach to local agencies. Whether a state, territorial, or metropolitan area, each member’s laboratory is unique with regard to demographics, size, and hospital system. To aid Level 3 Coordinators to fill any gaps in their programs, a one-stop document was proposed by CT-CWG members. Such a document would include practical information that could be used to develop a robust Level 3 program with consideration for each jurisdiction’s specific needs.

With guidance from APHL’s Environmental Health Committee (EHC), eleven volunteers from the CT-CWG participated in the project of developing a universal guidance for Level 3 Coordinators. Guidance development meetings were hosted by APHL members. To coordinate their efforts more efficiently, workgroup members utilized an APHL SharePoint site, conference calls, and email. The group established guidance recommendations that based on their experience, would be most helpful for Level 3 activity development. Each guidance topic was assigned to individuals or small teams for development. The group also solicited ideas from the entire APHL CT-CWG. The workgroup met approximately twice a month to discuss the progress, make edits, and in general, make improvements to the Level 3 Resource Handbook. The Laboratory Response Network for Chemical Threat (LRN-C) Level 3 Resource Handbook was completed within 11 months of its inception. The original version was prepared in November 2014 and is located in the LRN-C Toolkit SharePoint site hosted by APHL. The LRN-C Toolkit site is restricted to LRN-C members. Presenter: Teresa Miller, Chemical Threat Coordinator, Laboratory Systems, Bureau of Laboratories, Michigan Department of Community Health, Phone: 517.241.0925, Email: MillerT28@michigan.gov

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Comparative Analysis of Influenza Surveillance Data Using a Statistical Calculator J. Benfer, State Hygienic Laboratory at the University of Iowa, Coralville, IA Influenza surveillance is critical to provide situational awareness of virus circulation and to antigenic/genetic characterization of strains, selection of strains for the coming year’s flu vaccine, survey for emergent strains and antiviral drug resistance. Public Health Laboratories (PHLs) work with the Centers for Disease Control and Prevention (CDC) to perform annual surveillance testing. The CDC and Association of Public Health Laboratories (APHL) launched the “Influenza Virologic Surveillance Right Size (IVSRS)” project to better evaluate the program. The IVSRS project contains sample size calculator tools that can be used to assess the accuracy of prevalence indicators based upon the number of specimens tested. These calculators were applied to data sources from Iowa including PCR test results from the state PHL, Rapid Influenza Test Results (RIDT) from private laboratories and PCR from Influenza-Like Illness Network (ILINet) sites over a three year period. Results showed that the Iowa RIDT data trended similar to the national CDC data and had the greatest power due to the large number of results submitted. However, national data is heavily weighted with RIDT results and this likely underestimates the true prevalence due to reduced RIDT sensitivity compared to PCR. In contrast, the ILINet data is extremely volatile due to the low numbers of specimens submitted but are more sensitive at the start of the season.

Analysis of these data can help guide state influenza surveillance strategies to be more efficient and cost effective, balanced with the ability to provide information for situational awareness and novel event detection. Presenter: Jeff Benfer, MB (ASCP)cm, Supervisor , Virology/Molecular Biology Department , State Hygienic Laboratory at the University of Iowa, 2490 Crosspark Rd., Coralville, IA 52241, Phone: 319.335.4276, Email: jeff-benfer@uiowa.edu

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Center for the Advancement of Laboratory Science - Iowa's New Educational Resource D. Fayram and B. Hochstedler, State Hygienic Laboratory at the University of Iowa, Coralville, IA The State Hygienic Laboratory at the University of Iowa (SHL) has recently opened the Center for the Advancement of Laboratory Science (CALS). The CALS includes a conference center, classroom/meeting space, and hands-on training laboratory available to community, state, regional, and national public and environmental health partners for meetings, conferences, workshops, classes, and many other types of events. The facility can accommodate up to 150 people on site, and features technology that facilitates distance learning and collaboration via the teleconference or video conference systems. The CALS is a unique public asset in the state of Iowa, and among few resources nationally to bring together students, educators, researchers, working professionals, and other members of our scientific and geographic communities who share our commitment to advancing the future of laboratory science. A formal business operations plan helps to organize CALS program goals, maintain alignment with SHL’s Department of Training and Outreach, and ensure sustainability. SHL’s aim is to increase the quality and availability of laboratory science education and training opportunities, provide a space for the education and training of our current public and environmental health workforce, promote public and environmental health stewardship, raise public awareness about the services our organization provides, create a supplemental laboratory training space for government agencies, and provide critical surge capacity testing space during emergency events that occur in Iowa or the Midwest, such as a pandemic influenza outbreak or an environmental disaster. Objectives of this abstract: • Share the CALS business plan with public and environmental health partners around the nation. • Announce the completion and availability of the CALS as a resource for education, training, professional collaborations, and community engagement. • Advertise how public health partners can use this space for their own meetings, conferences and events. • Describe the available spaces in terms of capacity, AV, and other educational systems available.

• Demonstrate some of the current and future programs being held in the CALS, including collaborations with the University of Iowa and Kirkwood Community College. Presenter: Drew Fayram, State Hygienic Laboratory at the University of Iowa, 2490 Crosspark Rd., Coralville, IA 52241, Phone: 319.335.4864, Email: drew-fayram@uiowa.edu

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Development of a Conventional PCR Assay to Distinguish Five Genetic Mechanisms of Carbapenemase Production in Carbapenemase-producing Enterobacteriaceae K. Robinson1, 2, M. D’Angeli1, B. Hiatt1, R. Gautom1, W. Glover1; 1Washington State Department of Health, Shoreline, WA, 2Association of Public Health Laboratories, Silver Springs, MD Objective: We adapted a conventional PCR assay from singleplex to multiplex. This assay is capable of detecting and differentiating five genetic mechanisms of resistance in carbapenemase-producing Enterobacteriaceae (CPE). Study Design: Primers for five carbapenemase genes were optimized for use in a multiplex PCR using a standard thermocycler. Resulting amplicons were run and analyzed using the Agilent Tapestation. Five known carbapenemase-producing isolates from our CRE surveillance program, including KPC, NDM, VIM, IMP and OXA-48, were used to optimize each target, along with an exogenous internal control. Results: We have a working multiplex conventional PCR assay that can be used to test carbapenem-resistant Enterobacteriaceae surveillance samples to identify which are CPEs and determine their mechanism of action. Conclusions: The ability to provide epidemiologists with timely results allows for quick identification of CPE cases in Washington State, in turn ensuring results are rapidly communicated to local infection control to prevent and/or limit further spread. Presenter: Keri Robinson, Emerging Infectious Disease Fellow, Washington State Public Health Laboratories, 1610 NE 150th Street, Shoreline, WA 98155-7224, Phone: 206.418.5477, Email: keri.robinson@doh.wa.gov

P-18

Application of Next Generation Sequencing Technology in the Diagnosis of Human Viral Pathogens J. Chen1, F. Ge2, J. Parker1, S.C. Choi2, M. Layer2, K. Ross3, B. Jilly3; 1Alaska State Public Health Virology Laboratory, Fairbanks, AK, 2University of Alaska Fairbanks, Fairbanks, AK, 3Alaska State Public Health Laboratories, Anchorage, AK The application of next generation sequencing (NGS) technology in the diagnosis of human pathogens is hindered by the fact that pathogenic (especially viral) sequences often exist in

scarcity in human clinical samples, which requires subsequent deep sequencing and extensive bioinformatics analysis. Here we report a method we called “Preferential Amplification of Pathogenic Sequences (PATHseq)” that can be used to greatly enrich pathogenic sequences. Using a computer program, we developed 8-, 9-, and 10-mer oligonucleotides called “non-human primers” that do not match the most abundant human transcripts but match to some or all human pathogenic viruses. Instead of using random primers in the construction of cDNA library, the PATHseq method recruits these short non-human primers, which in turn, is able to preferentially amplify all non-human (presumably pathogenic) sequences. Theoretically, these primers are short enough to broadly detect pathogens (viruses and bacteria) above a given threshold genome size. Using this method, we were able to enrich pathogenic sequences up to 200 fold in the final sequencing library. This method does not require prior knowledge of the pathogen or assumption of the infection, therefore, provides a fast and sequence-independent approach in identifying known and novel human pathogens. We applied PATHseq method in the diagnosis of an unknown respiratory tract infection and successfully identified a novel variant of streptococcus pneumonia. The PATHseq method, coupled with NGS technology, can be broadly used in identification of known pathogens as well as discovery of new pathogens. Presenter: Jack Chen, PhD, Deputy Director, Virology Laboratory, Alaska Division of Public Health Laboratory, 930 Sheenjek Rd., PO Box 60230, Fairbanks, AK 99706-0230, Phone: 907.474.6966, Email: j.chen@alaska.edu

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Interactive Training Webinar for Newborn Screening Specimen Collection P. Held and C. Brokopp, Wisconsin State Laboratory of Hygiene, University of Wisconsin-Madison, Madison, WI A successful newborn screening program is dependent upon the pre-analytical phase of screening, specifically specimen collection and transport. If hospitals and midwives provide the laboratory with an initial specimen that meets a defined standard for quality in a timely manner, the overall testing and time to reporting improves, thereby improving the quality of the whole program. Data from recent Wisconsin monthly quality assurance reports showed that specimen collection, specifically the rate of unsatisfactory specimens, could be improved in many of the submitting facilities. The Wisconsin NBS program sought to address the unsatisfactory specimen rate by developing an interactive training webinar for specimen collection. Specifically, the online training will present the procedures for proper specimen collection, a suggested specimen review process prior to submission, and a framework for monitoring key pre-analytical quality indicators. The training will contain three parts: a pre-test to assess initial knowledge of specimen collection, a 30 minutes training webinar, followed by a post-test to assess gained knowledge as a result of the training. The plan is for the training webinar to be distributed to all submitters with the

intended audiences of phlebotomists, nurses, medical technicians, midwives, and other healthcare workers who participate in the screening process. Upon implementation of the webinar, pre-and post-test data from all participants will be complied to assess the overall effectiveness of the training. Test scores will also be made available to the individual learner, immediately after completion of the training, to assess whether the learning objectives were met and continuing education credits can be awarded. Lastly, the Wisconsin NBS program will continue to track the unsatisfactory specimen rate for each submitter and look for improvements as a result of the training webinar. Presenter: Patrice K. Held, PhD, FACMG, Co-Director NBS & BCG Lab, Wisconsin State Laboratory of Hygiene, 465 Henry Mall, Madison, WI 53706, Phone: 608.265.5968, Email: patrice.held@slh.wisc.edu

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Improving Regulatory Compliance and Good Laboratory Practice (GLP) in New Jersey Certificate of Waiver (CW) Laboratories S. Mikorski, New Jersey Department of Health, West Trenton, NJ Unlike most states, New Jersey has a clinical laboratory licensure law, and does not solely rely on the federally funded Clinical Laboratory Improvement Amendment (CLIA) program for regulation of clinical laboratories. CLIA defines laboratories on a tiered system based on testing complexity, designates their lowest complexity level as Certificate of Waiver (CW) laboratories and requires only registration and non-punitive educational surveys for these labs. A very small percentage of CW laboratories are exempt from NJ licensure; the majority are required to obtain a license and comply with NJ requirements. In preparation for proposing regulatory change, in 2013 we asked the question, “Does New Jersey laboratory licensure impact the quality of testing done in New Jersey CW laboratories”? In order to answer the question a survey was administered to 117 New Jersey CW laboratory staff who registered for APHL-funded training classes on Good Laboratory Practice (GLP). Survey results indicated that New Jersey licensed CW laboratory staff were more knowledgeable about quality assurance and reported more frequent use of Good Laboratory Practices (GLP) in their laboratories than non-licensed CW laboratory staff. Based on that observation, in 2014 the NJ laboratory licensure program in conjunction with the NJ CLIA program and the Laboratory Outreach program, submitted a proposal to APHL that will 1. Expand accessibility of existing CW training 2. Improve outreach to physicians to create awareness of federal and state regulations and to provide appropriate compliance resources. 3. Propose update to NJ regulations with regard to waived testing.

In order to meet these goals we are actively developing a physician office laboratory listserv, converting our classroom training to an online format, developing a webinar for physicians on regulatory requirements which can be archived and seeking more information on best practices for inclusion in the proposed regulatory changes. The poster will describe these efforts in detail. Presenter: Susan Mikorski, MEd, MT(ASCP)SM, Laboratory Outreach Coordinator, Environmental and Agricultural Laboratories, New Jersey Department of Health, P.O. Box 361 Trenton, NJ 08625-0361, Phone: 609.406.6878, Email: Susan.Mikorski@doh.state.nj.us

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Improving Submission Quality in New Mexico S. Nicholetto, A. Treloar and S. Master, The Scientific Laboratory Division, Albuquerque, NM The Scientific Laboratory Division (SLD) is the sole public health laboratory in the state of New Mexico and provides comprehensive testing for the population. As a geographically large state with a significant rural population, infrequent communication with and training of rural healthcare providers can lead to specimen handling and submission errors. Critical gaps or lack of knowledge in these two areas frequently result in specimen rejection by the laboratory. In compliance with CLIA Preanalytic Quality Systems regulations and SLD’s Quality Management System, the laboratory strives to decrease the number of rejected specimens and ensure testing of high-quality clinical and animal specimens. Rejecting specimens leads to patient inconvenience and testing delays, whereas improperly prepared specimens limit the laboratory’s ability to generate high quality test results for our submitters. Utilizing an APHL Innovations in Quality PHL Practice grant, the SLD developed and utilized hands-on training sessions for public health offices and selected reference laboratories. Training sessions were followed by newly-instituted competency assessments. An easy to use specimen submission & handling card deck based on the laboratory’s Directory of Services was developed and distributed to be used as a quick reference for submitters in an effort to increase compliance. The results of the SLD’s training efforts will be presented. Presenter: Allison Treloar, The Scientific Laboratory Division, Biological Science Bureau, 1101 Camino de Salud, NE , Albuquerque, NM 87102-4519, Phone: 505.383.9160, Email: allison.treloar@state.nm.us

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Validating Efficacy of Web-Based Training Modules for CLIA Regulatory Requirements K. Anderson1, J. Schwenken2, A. Bruesch1, W. Loumeau1, K.Fackrell1, C. Ball1; 1Idaho Bureau of Laboratories, Boise, ID, 2Boise State University, Boise, ID Introduction: The Idaho Bureau of Laboratories (IBL) 2014 Idaho Sentinel Laboratory Network Needs Assessment indicated that web-based training regarding Clinical Laboratory Improvement Act (CLIA) regulations, proficiency testing (PT) requirements, and laboratory Quality Improvement (QI) were of primary interest to facilities conducting diagnostic testing. To respond to this need, IBL developed a web-based training module focused on CLIA and state PT requirements. The module provides an on-demand resource to learn about the proficiency testing requirements needed to maintain a valid accreditation program in Idaho and offers guidance for clinical laboratory staff as they troubleshoot failed PT events and develop corrective action plans. Objectives: Following this training, participants will be able to: 1) classify CLIA certificate levels and describe the associated PT requirements for each level; 2) differentiate between PT requirements for regulated and non-regulated analytes; 3) describe strategies for successfully troubleshooting failed proficiency tests; and 4) list required elements for constructing an acceptable plan of correction in Idaho. Study Design: IBL conducted two focus group sessions allowing participants to beta-test a web-based training module prior to statewide deployment. Focus group responses to specific learning activities were collected pre- and post-training to assess efficacy of the module in improving knowledge of the learning objectives. Results: Pre- and post- test results demonstrate the impact of the training module on participant ability to interpret and apply CLIA PT regulatory requirements. Additionally, participant feedback on training content, question style, and clarity of concept delivery was captured and utilized to improve the user experience for the final training module. Conclusion: Concise, focused training modules can impact learner ability to interpret complex regulatory requirements and apply them to laboratory-specific situations. The use of focus groups to beta-test a web-based training module prior to deployment results in substantial edits and improvements in the efficacy and quality of the final product. This model may lead to the reduction in the number of deficiencies among Idaho laboratories participating in the CLIA program. Presenter: Katey Marie Anderson, MS, Laboratory Improvement Manager, Idaho Bureau of Laboratories, 2200 Old Penitentiary Rd., Boise, ID 83712, Phone: 208.334.2235 x 245, E-mail: andersok@dhw.idaho.gov

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Phlebotomy Training for Public Health Nurses and Nursing Personnel J. Madlem and S. Matheson, ISDH Laboratories, Indianapolis, IN A phlebotomy training course was developed in 2012 for local health department nurses and nursing personnel throughout Indiana. During the development of this course, the Indiana State Department of Health (ISDH) Laboratory collaborated with the ISDH Immunization Program to ensure a more prepared and competent workforce in the event of outbreak scenarios in Indiana. The one-day course consisted of a didactic session in the morning and a practical session in the afternoon. During the remainder of the day, attendees were expected to perform one venipuncture and one nasopharyngeal swab collection under close supervision so that comments could be provided. A total of 18 classes have been held to date. Thus far, 205 nurses, disease investigators and other clinicians have attended the trainings provided in each of Indiana’s ten public health preparedness districts. Test scores indicate an average of 45.7% increase in learning over all courses, as was determined with the Kirkpatrick Model of Evaluation using pre- and post-lecture exams. Now offered three times annually, this course has often been filled to capacity with waiting lists. A post-training evaluation was conducted among attendees once all districts had received at least one training. Results indicated 100% were either satisfied or extremely satisfied with the course; 100% would recommend the course to others; 77% felt completely comfortable drawing blood after the course; 23% felt comfortable drawing blood with an observer; 31% reported positive changes in the workplace after attending the course. The ISDH Laboratory’s Outreach and Training Team intends to keep this workshop in their portfolio, offering it regionally throughout the state. Finally, the increase in post-test scores clearly indicates a statistically significant level of learning in a single day, making a strong case for this training to be continued. Analysis of course evaluations emphasize other positive effects such as being more confident when performing venipuncture, knowing how to reduce risks, proper vein selection and order of draw, understanding applicable regulations and standards of practice for phlebotomy, and building partnerships with other public health personnel. Based on these results, this workshop is one of the most successful trainings offered by the ISDH Laboratory. Presenter: Jyl Madlem, MS, MT(AMT), Indiana Public Health Laboratory, 550 W. 16th St., Suite B, Indianapolis, IN 46202, Phone: 317.921.5574, Email: jmadlem@isdh.in.gov

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The First U.S. Case of Middle East Respiratory Syndrome Coronavirus (MERS-CoV): Underscoring the Importance of Cooperative Partnerships S. Dearth, Indiana State Department of Health, Indianapolis, IN The Indiana State Department of Health (ISDH) Laboratories maintain and promote a strong relationship with ISDH Epidemiology and Indiana clinical laboratories. This relationship has cultivated excellent year-round surveillance of circulating influenza along with other respiratory viruses of public health interest. This partnership and enhanced surveillance effort was highlighted when Indiana was the first state in 2011 to detect cases of human infection with influenza A(H3N2)v virus. This successful collaboration was once again underscored during the 2014 investigation of the first confirmed MERS-CoV specimen within the United States. On April 30th, 2014, the ISDH Epidemiology Resource Center was made aware of a patient under investigation (PUI) for Middle East Respiratory Syndrome (MERS) by Community Hospital in Munster, Indiana. This patient returned to the U.S. on April 24th, 2014 after a stay in Saudi Arabia. The laboratory received specimens from the PUI on May 1st, 2014. By 3:00PM, the ISDH Laboratories had determined the specimens were presumptive positive for MERS-CoV and contacted the CDC for further instructions. The CDC confirmed the results mid-afternoon on May 2nd, 2014. This specimen was eventually confirmed as the first MERS-CoV case in the United States. Subsequently, 60 contacts were identified and tested for MERS-CoV. No additional MERS-CoV cases were identified. The strong relationship between the ISDH Laboratories, ISDH Epidemiology, Community Hospital in Munster, and the CDC, highlight the value of cooperative partnerships between government entities and the private sector. These partnerships facilitated excellent communication, and ensured timely collection and testing of samples from the PUI and all PUI contacts. This collaboration drastically reduced the risk of further MERS-CoV exposure in the State of Indiana. Presenter: Stephanie Dearth, Indiana Public Health Laboratory, 550 W. 16th St., Suite B, Indianapolis, IN 46202, Email: StDearth@isdh.IN.gov

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Identification and Screening of Methamphetamine Contaminated Homes in Indiana M. Starzynski and P. Patel, Indiana State Department of Health, Indianapolis, IN Indiana has the dubious distinction of having more clandestine methamphetamine drug manufacturing labs than any other state in the nation. In 2013, 1,797 meth labs were identified

in Indiana. Meth abuse and manufacture is so widespread that in 2014 the Indiana State Police had to warn residents that trash left outdoors by people making meth may be toxic, flammable, corrosive or acidic. When a residential drug lab is seized, there is usually residual contamination of the property, and any new occupants would potentially be exposed to hazardous chemicals. For example, an Indiana resident tested positive for methamphetamine during an employment drug screening after moving to a home that had been used as a meth lab. For this reason, our county health departments must send wipe samples from suspect meth labs to test for residual contamination. Testing a single residence could cost the county health departments thousands of dollars and required sending these samples to an out-of-state commercial laboratory. In 2012, a local health department asked ISDH Laboratories if we could provide methamphetamine residue screening as a service to the local health departments so they could determine whether a residence needed decontamination without incurring large costs. In response, the ISDH Chemistry Laboratories developed a method for the analysis of methamphetamine residue based on NIOSH method 9106 and the California Department of Toxic Substances Control’s standard operating procedure. We now provide this screening service to local health departments upon request. Since testing was initiated in May 2012, 66 samples have been submitted and analyzed for methamphetamine contamination. Reference: - Guilt by Contamination: Identification and Screening of Methamphetamine Contaminated Homes in Indiana, Pradip Patel and Mark Starzynski, Indiana State Department of Health Laboratories, Chemistry Laboratories Division, 550 West 16th Street, Suite B, Indianapolis, Indiana 46202.

Presenter: Mark Starzynski, Organic Chemistry Supervisor, Indiana Public Health Laboratory, 550 W. 16th St., Suite B, Indianapolis, IN 46202, Phone: 317. 921-5880, Email: Mstarzyn@isdh.IN.gov

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Tailoring a Pharmaceutical and Personal Care Product Method to a State with Large Operations of Swine and Poultry: Using Licensed Medicated Feed Ingredient Lists to Better Target Emerging Contaminants in Water and Sediment M. Hagerman, Indiana State Dept of Health, Indianapolis, IN An in-house Solid Phase Extraction - Liquid Chromatography Tandem Mass Spectrometry (SPE-LC/MS/MS) method for the analysis of Pharmaceuticals and Personal Care Products (PPCP) in water was tailored to the specific needs of Indiana, a state that has numerous large swine and poultry feeding operations. The increasing presence of these large swine and poultry farms has raised citizen concerns about possible water or soil contamination and the development of antibiotic resistance as a result of the animal waste generated on these farms. The PPCP analytical method was expanded to include veterinary drugs present in commercially-available

feed using a list published by the Office of Indiana State Chemist (OISC). The OISC licenses all commercial animal feed used in the state, including medicated feeds that contain various classes of antibiotics, additives and growth promoters at therapeutic or sub-therapeutic levels. Water samples are extracted using an Oasis hydrophilic-lipophilic balance (HLB) cartridge. Soil samples are extracted with a series of solvents, evaporated to almost dryness, then reconstituted in mobile phase. Extracts are analyzed on a liquid chromatograph using a C-18 column, followed by electrospray ionization and MS/MS detection. Most of the commercially listed veterinary medications were added successfully to the method. The expanded method can be used to analyze drinking and surface waters as well as soils and sediments that are at risk of contamination from large swine or poultry operations. Presenter: Mary, Hagerman, MS, Chemical Threat Coordinator, Public Health Protection and Laboratory Services, Indiana State Department of Health, 550 W. 16th St., Suite B, Indianapolis, IN 46202, Phone: 317.921.5553, Email: mhagerma@isdh.in.gov

P-27 The Armenian-Indiana Connection: Helping to Implement QMS on a National Scale C. Grimes, Indiana State Department of Health, Indianapolis, IN Background: When the U.S.S.R. disbanded in 1991, Armenia was allowed to stand on its own again. Almost immediately, the new nation was engulfed in a war with Azerbaijan. During the years immediately following the Soviet pullout, much of the infrastructure was unusable, so even major urban centers were without power or water. In spite of this struggle, Armenians wanted to improve their national public health system. They worked closely with the World Health Organization (WHO) to meet International Health Regulation (IHR) requirements. They performed a gap assessment and reached out to the ASM-CDC International Lab Strengthening Program. This fellowship program for resource-limited countries could help Armenia train their PHL leaders in lab systems development and the implementation of QMS by mentoring with a U.S. PHL. Methods: In 2013, the ASM-CDC Global Fellowship sponsored three PHL leaders from the Armenia to visit the Indiana State Dept. of Health Labs (ISDHL). During this 2 week visit, ISDHL provided the groundwork for basic QMS implementation in various clinical lab settings, detailed accounts of how to achieve ISO 17025 accreditation, establishment of an environmental lab network throughout the state, and federal requirements for clinical lab operations. In 2014, the ASM-CDC Global Fellowship program sponsored the ISDHL QA Director to visit Armenia to follow up on the initial mentoring provided in 2013. Once this visit was completed, the Armenian fellows returned to the ISDHL to garner more knowledge tailored to their specific national needs, i.e. creating a legal framework to incorporate QMS requirements into lab licensure and implementing QMS throughout their PHL network. Much of this experience came from directly observing external regulatory audits at the ISDHL.

Results: As a direct result of the Armenian visit to the U.S., the previous three-armed PHL system was consolidated into one organization. This new framework had to be backed by appropriate laws, so the ASM fellows helped write the laws for their national system. Conclusions: The Armenian-Indiana connection helped direct development of the new Armenian PHL system. Presenter: Chris Grimes, QA Director, Indiana State Dept. of Health Laboratories, 550 W. 16th St. Suite B, Indianapolis, IN 46202, Phone: 317.921.5805, E-mail: cgrimes@isdh.in.gov.

P-28 Using a Pooling Strategy for the Detection of Recent Hepatitis C Infections J. Gentry, Indiana State Department of Health, Indianapolis, IN Background: In 2011, the Indiana State Department of Health (ISDH) noted an increase of early Hepatitis C infections among young patients with a history of illegal drug use. In 2013, ISDH Laboratory initiated a project to capture early HCV infections. The APTIMA NAAT assay was used to test pools of HCV antibody negative serum samples. Objective: ISDH Lab implemented a pooled strategy using NAAT testing in order to detect HCV RNA in HCV antibody negative serum samples. Methods: ISDH routinely screens serum samples for HCV IgG using Ortho Clinical Diagnostics VITROS anti-HCV reagents. HCV antibody negative samples were collected and divided into intermediate pools of eight samples each. Six intermediate pools were combined into one master pool of 48 total samples. Pools were tracked using a barcode scanner and an Excel spreadsheet. A TECAN pipettor was used to pipette the pools. Master pools were tested once per week. When a master pool was identified as being reactive, the intermediate pools were tested the following morning, with the initial samples being tested that afternoon to identify the individual reactive sample. Follow up samples were immediately requested and NAAT tested to rule out potential cross contamination that might have occurred during the testing process. Additional samples were requested at the three month mark to verify seroconversion. Results and patient demographics were compiled for all newly identified cases. Results: The study period ran from May to December, 2013. A total of 12,156 samples were divided into 235 pools and NAAT tested. Samples from 21 patients were confirmed positive by NAAT testing a second collection. 19 of these 21 seroconverted on successive samples (a 3rd sample was not available for 2 other patients). The mean age of the confirmed positive patients was 26. All were white, and 76% were male. 71% of the samples were submitted by Indiana Department of Correction facilities, with the remaining 29% submitted by Counseling and Testing Sites. Most of the patients had a history of illegal drug use. Conclusion: This data demonstrates that a pooled NAAT testing strategy is an effective and efficient method of identifying recent HCV infections in a high risk population. Early detection is crucial to halting the further spread of this infectious disease and allows for earlier treatment.

Presenter: Jessica Gentry, Serology/TB Microbiologist Supervisor, Laboratory Services, Clinical Microbiology, Indiana State Department of Health, 550 West 16th St., Suite B, Indianapolis, IN 46202, Phone: 317.921.5858, Email: jgentry@isdh.in.gov

P-29 LimsNet: An Internet-based Laboratory Sample Submission System – The Core Data Structure and Information Flow H. Fu, Indiana State Department of Health, Indianapolis, IN Public health laboratories accepting outside test samples often need an internet based on-line submission system, such as LimsNet, for external customers to send in pertinent test sample information, and to check test results on-line. The key component of such submission system is the mapping between its data fields and the data structure of the underline lab information management system, such as STARLIMS in our case. This presentation focus on two areas: the internal data mapping mechanism between LimsNet and STARLIMS, and the LimsNet main architecture. The data mapping mechanism can be best viewed from the data structure mapping, and from the information flow. The data structure mapping will explain the inner works of LimsNet and its relationship to the lab information management system. The information flow describes what happens from the moment a LimsNet user submit a new sample, till the final results are approved by lab supervisors. This will be presented from the LimsNet users’ perspective, and from ISDH Lab analysts’ perspective. Understanding of this core knowledge is critical for an on-line submission system. The LimsNet main architecture part will present major components of the LimsNet software. This architecture model will be helpful to agencies interested in developing their own on-line sample submission system. Presenter: Henry Fu, Indiana State Department of Health, 550 West 16th St., Suite B, Indianapolis, IN 46202, Email: Hfu@isdh.IN.gov

P-30 LimsNet: A Case Study in the Benefits of an Online Test Ordering and Reporting System Interfaced to a Laboratory Information Management System (LIMS) C. Rothenbacher, Indiana State Department of Health, Indianapolis, IN The Indiana state department of health (ISDH) implemented STARLIMS, a commercial off the shelf laboratory information management system, in 2007. STARLIMS did not have a viable web-based test ordering and reporting system. ISDH built and implemented its own web-based system, LimsNet. LimsNet has provided a number of benefits to the lab, including: • Increased accuracy: The replacement of paper forms with a web based ordering system has reduced the date entry error rate. In addition, much data can be validated before the submitter ships the sample, preventing situations in which lab staff must contact submitters to collect missing information or correct errors. • Improved turnaround time: samples now arrive at the lab pre-accessioned, greatly streamlining the receiving process. In addition, because submitters receive results electronically in real time rather than in the mail, turnaround time from the submitters’ point of view is decreased by approximately one day. • Support for Billing: Following the implementation of the Affordable Care Act, there has been a movement pushing public laboratories away from reliance on grant funding and toward billing third party insurance. Web based test ordering allows patient insurance information to be collected at the time of the test order, and, in some cases, even checked against the Medicaid eligibility database so that corrections can be made before the sample is shipped. • Simplified document retention: Storing paper submission forms was once an onerous process, and took up large amounts of space. LimsNet has almost entirely eliminated the need to store paper documents. • Reduced cost: An entire division within the lab was dedicated to performing data entry on incoming paper lab requests, and to contacting submitters by phone who filled out paper lab request forms incorrectly or incompletely. That division was also responsible for printing paper reports, stuffing envelopes, and mailing them to submitters. That entire division is no longer needed, and personnel have been reassigned to other parts of the agency, or have left due to attrition. Presenter: Carl Rothenbacher, MBA, PMP, LIMS Project Manager, Indiana State Department of Health Laboratories, 550 West 16th St., Suite B, Indianapolis, IN 46202, Phone: 317.921.5508 , Email: crothenbacher@isdh.in.gov

P-31 Development of an SYBR Green qPCR Protocol for Monitoring Host Specific Fecal Contamination in Recreational Waters P. Higgins, M. McGarvey, M. Bardburn and G. Walters, Pennsylvania Department of Environmental Protection, Harrisburg, PA The Bureau of Point and Non-Point Source Management (BPNPSM) and Bureau of Laboratories (BOL) of the Pennsylvania Department of Environmental Protection cooperated to develop a real time, quantitative PCR (qPCR) protocol for the detection and monitoring of host specific fecal contamination in recreational waters. The BPNPSM collected samples from various Pennsylvania rivers impaired by high levels of fecal indicator bacteria. The BOL analyzed the samples by filtration onto a membrane, purification of the bacterial DNA, and qPCR detection of host gene targets (human, bovine, swine, and avian) using a Bacteroides SYBR Green protocol. The detection limit was determined to be 250 gene copies per 100 mL of sample and results were translated into potential contribution of E. coli per 100 mL using conversion factors generated from local host fecal samples. Studies will continue to expand this useful and cost effective qPCR protocol for the detection and monitoring of additional fecal contamination sources in recreational waters. Presenter: Pamela J. Higgins, PhD, Special Assistant to Laboratory Operations, Pennsylvania Department of Environmental Protection, Bureau of Laboratories, 2575 Interstate Dr., Harrisburg, PA 17110, Phone: 717.346.8233, Email: pahiggins@pa.gov

P-32 Compliance and Time Delay of Chlamydia, Gonorrhea, and Syphilis Laboratory Reports Sent to Public Health P. Lai1,2, U. Kirbiyik1,3, J. Johns3, B. Dixon1,3; 1Regenstrief Institute, Indianapolis, IN, 2Indiana University School of Informatics and Computing, Indianapolis, IN, 3Indiana University Richard M. Fairbanks School of Public Health, Indianapolis, IN 46202 USA Regenstrief Institute, Indianapolis, IN Communicable disease reports sent by laboratories create a potential challenge for public health disease surveillance and management as these reports are often collected with various degrees of timeliness raising the concern about the delay in patient information received. According to Indiana state law, chlamydia, gonorrhea, and syphilis reports from laboratories are required to be sent to public health within 72 hours after a positive test confirmation. Thus, lab reports must be prompt and comply with regulation to ensure accurate disease assessment by public health authorities. The objective of this study is to analyze the time delay between chlamydia, gonorrhea, and syphilis positive test result and when a lab sends a report to a local public health department.

We analyzed a sample of 559 chlamydia, 131 gonorrhea, and 75 syphilis paper-based lab reports received via fax by an urban county public health department. Chlamydia and gonorrhea reports were received between May and July 2012 while syphilis reports were received between December 2011 and July 2012. These timeframes were selected based on disease incidence rates for the county to support detection of a difference in timeliness with >80% power. Time delay was measured using the difference in the number of days between a positive lab result and when the result is reported to public health. Lab reports were considered compliant with state law if the time delay differential was 72 hours or less. We also examined the effect of weekend delay if lab tests were confirmed positive on a Thursday or Friday. Using Fisher’s exact test, results show an association between the day of week and time delay of laboratory reports (p < 0.0001). 82.38% of all lab results confirmed positive on Friday were reported to public health within 72 hours while only 31.03% of reports on Thursday were reported within the same time frame. Monday through Wednesday reports were compliant with ranges from 93.01% to 98.46%. The day of the week in which a lab result is determined plays an important role in the timeliness of lab reports sent to public health. Further research on lab workflow should be investigated to determine potential solutions for enhancing timeliness. Furthermore, greater use of electronic laboratory reporting may be a strategy to improve timeliness in disease reporting processes. Presenter: Patrick T.S. Lai, MPH, Graduate Student and Assistant, IUPUI School of Informatics and Computing, Indianapolis, IN, Email: ptlai@imail.iu.edu

P-33 Building Biomonitoring Capacity in States A. Mowbray and L. Romanoff, Centers for Disease Control and Prevention, Atlanta, GA Objective: Biomonitoring provides unique and valuable information on human exposure to environmental compounds by measuring chemicals or their breakdown products in people’s blood or urine. CDC uses biomonitoring to conduct an ongoing assessment of the U.S. population’s exposure to environmental chemicals. However, CDC’s biomonitoring data are nationally representative and do not provide exposure information by specific state or locality. Since 2001, CDC’s Division of Laboratory Sciences (DLS) has worked to establish and expand national capacity to conduct high-quality biomonitoring science in state public health laboratories: through a planning grant; an implementation grant; and a five-year cooperative agreement. In 2014, CDC developed a new funding opportunity announcement to build on previous, successful CDC-funded program and help additional states use biomonitoring to assess chemical exposures of concern in their communities.

Results: Twenty applicants (representing a total of 27 states) submitted proposals for funding, which were evaluated competitively by an objective review panel. Following the review, CDC started a five-year cooperative agreement cycle with six awardees: California, Massachusetts, New Hampshire, New Jersey, Virginia, and Utah (lead member of the Four Corners States Biomonitoring Consortium, which also includes Arizona, Colorado, and New Mexico). Awarded states use funding to purchase laboratory equipment and supplies; hire and train specialized staff; and conduct fieldwork and data analysis. As part of the cooperative agreement, CDC provides training and technology transfer, quality assessment services, and technical assistance to awardees. Conclusions: CDC’s support of state biomonitoring over the past decade has resulted in increased capability and capacity of state public health laboratories to assess people’s exposure to chemicals. Presenter: Amy Mowbray, PhD, Public Health Advisor, NCEH/DLS, Center for Disease Control and Prevention, 4770 Buford Hwy NE, MS F-20, Atlanta, GA 30341, Phone: 770.488.0183, Email: amowbray@cdc.gov

P-34 Restricted Experiment Requests, Division of Select Agents and Toxins, 2006-2013 J. Smith, D. Gangadharan and R. Weyant, Centers for Disease Control and Prevention, Atlanta, GA Objective: The objective of this poster is to describe the trends and demographic data associated with restricted experiment (RE) requests for work with select agents and toxins. Restricted experiments (42 CFR. § 73.13) are defined as: (1) Experiments that involve the deliberate transfer of, or selection for, a drug resistance trait to select agents that are not known to acquire the trait naturally, if such acquisition could compromise the control of disease agents in humans, veterinary medicine, or agriculture. (2) Experiments involving the deliberate formation of synthetic or recombinant nucleic acids containing genes for the biosynthesis of select toxins lethal for vertebrates at an LD[50] <100 ng/kg body weight. Methods: Demographic information was collected from requests to perform restricted experiments (REs) received by the CDC Division of Select Agents and Toxins (DSAT) from January 2006 through December 2013. The demographic information collected included the type of entity submitting the request, the select agent or toxin identified in the experiment, the type of experiment being conducted, and the final disposition of the request. Results: DSAT received 618 requests from entities to conduct REs with select agents and toxins. Fifteen percent of the requests met the definition of a “restricted experiment”. DSAT approved 34% of the requests under the “restricted experiment” category. All approved REs involved recombinant nucleic acids that encode for select toxins. The DSAT did not approve 60 RE requests that involved deliberately transferring drug resistance traits into select agents. These experiments posed a heightened risk to public and/or animal health and safety.

Conclusion: All experiments that were denied involved the deliberate transfer of clinically useful drug resistance traits to a select agent not known to acquire the trait naturally, which may compromise the treatment or control of disease if deliberately or accidently released. For those experiments that were denied, other drug resistance traits that did not compromise the use of the drug in treatment or control of disease were available to use as selection markers in recombinant experiments. Presenter: Jacinta Smith, MS, Division of Select Agents & Toxins, Centers for Disease Control and Prevention, 1600 Clifton Rd. NE, MS A-46, Atlanta, GA 30333, Phone: 404.639.3344, Email: cvd2@cdc.gov

P-35 Evaluation of a Continuing Education Activity on Good Laboratory Practice Recommendations for Newborn Screening and Biochemical Genetic Testing B. Chen1, N. Redmond1, K. Breckenridge2, B. Su2, J. Roselez2, J. Ojodu2; 1Centers for Disease Control and Prevention, Atlanta, GA, 2Association of Public Health Laboratories, Silver Spring, MD Background and Objectives: Rapid expansion of newborn screening activities requires effective educational resources to help laboratory and healthcare professionals enhance knowledge of quality practices in this area. This study evaluated participants’ feedback in a free, online continuing education (CE) activity for the 2012 CDC guideline “Good Laboratory Practices for Biochemical Genetic Testing and Newborn Screening for Inherited Metabolic Disorders”. Study Design: CE Participant responses were evaluated using the 4-level Kirkpatrick Training Evaluation Model. Participants’ feedback on how they learned about this CE activity was monitored to assess the effectiveness of recent marketing efforts to increase awareness of this educational resource. Results: As of December 2014, 391 of 558 registered participants (70%) completed the CE activity and earned CE credits. Evaluation measures suggest that participants were overall satisfied with the learning activity, with 89% stating that the CE activity met their educational needs, 92% rating the difficulty level as appropriate, and 91% indicating that the format and delivery method were helpful. Approximately 80% of participants stated that they could apply the knowledge gained when given an opportunity. Participants reported planning to use the recommendations to develop education materials, laboratory policies and procedures, and laboratory standards or guidelines. The effectiveness of recent marketing efforts, including journal advertisements, promotional materials and presentations at professional conferences, is continuously monitored and results will be reported. Conclusion: The educational value of the CDC guideline is supported by the overall reaction and learning results of the CE participants. Ongoing evaluation activities are needed to assess the factors influencing CE participation and knowledge translation to practice.

Presenter: Nakeva Redmond, MPH, ORISE Fellow, LREB/DLPSS/CSELS, Centers for Disease Control and Prevention, 1600 Clifton Road, NE, MS G25, Atlanta, GA 30333, Phone: 404.498.0222, Email: ygu9@cdc.gov

P-36 Assessment of Influenza Molecular Diagnostic Capabilities Among US Public Health Laboratories L. Berman1, L. Malapati3, C. Warnes1, J. Wess4, J. Murray4, M. Hoelscher1, C. Staats2, S. Muir-Paulik5, S. Lindstrom1; 1Centers for Disease Control and Prevention, Atlanta, GA, 2Booz Allen Hamilton, Atlanta, GA, 3Leidos, Atlanta, GA, 4Battelle Memorial Institute, Atlanta, GA, 5Association of Public Health Laboratories, Silver Springs, MD Background: The Influenza Division (ID) of the CDC provides CDC Influenza Molecular Diagnostic Performance Evaluation Panel (FluDx PEP) to assess the capabilities of US public health laboratories (PHLs), and to aid in fulfilling their CLIA/CAP requirements. After the introduction of a number of updates to the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel (CDC rRT-PCR Dx Panel) in 2012 and 2013, the FluDx PEP of 2013 measured how well updates were implemented by PHLs. Overall, performance decreased, particularly with PHLs abilities to correctly identify samples that were representative of the updates. Only 55% of labs had established testing for influenza B genotyping and A/H7 while 92% correctly reported results for detection of A(H3N2)v variant virus. Subsequent technical training provided by the CDC ID in 2014 to 58 PHLs focused to specifically address recent updates to the CDC rRT-PCR Dx Panel. For the 2014-2015 influenza season, the FluDx PEP was offered twice in 2014 to US PHLs qualified to receive the CDC rRT-PCR Dx Panel. Participation in these exercises was voluntary and non-punitive. Method: All qualified US PHLs were invited to request the CDC FluDx PEP in July and November, 2014. Ninety PHLs participated in the July exercise while 84 laboratories enrolled in the November evaluation. The panel included 9 simulated human specimens that contained inactivated influenza viruses and/or cultured human cells, including 6 influenza A samples (A(H3N2), A(H3N2)v, A(H1N1)pdm09, A(H5N1), and A(H7N9)), 2 influenza B samples (Yamagata and Victoria lineages), and 1 negative sample. The performance of individual laboratories was assessed based on the laboratory’s ability to correctly detect and characterize the included viruses though no grades or rankings were assigned. Results and Conclusion: Results from the July, 2014, exercise showed 87 of 90 (97%) laboratories correctly identified all nine evaluation samples while 79 of 84 (94%) correctly identified all nine samples in the November exercise. These exercises demonstrated improved overall performance and implementation of assay updates as a result of extensive training efforts. The CDC FluDx PEP, while supporting PHLs to meet their CLIA requirements, provides CDC with valuable data to understand testing capabilities and identify training needs.

Presenter: LaShondra Berman, Microbiologist. DDT/VSDB/ID/NCIRD, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS D-30, Atlanta GA 30333, Phone: 404.639.1686, E-mail: zhj5@cdc.gov

P-37 Detection of Multiple Influenza Viruses from Human Specimens Due to Live Attenuated Influenza Vaccine Viruses or Co-infection of Wild-type Influenza S. Lindstrom1, L. Berman1, L. Malapati1, B. Shu1, W. Davis2, S. Emery1, N. Barnes2, J. Winter1; 1Centers for Disease Control and Prevention, Atlanta, GA, 2Battelle, Atlanta, GA Background: Live attenuated influenza vaccine (LAIV) is a nasal spray vaccine that contains multiple influenza A and B viruses that replicate in the nasopharynx. Specimens collected from individuals recently immunized with LAIV may be positive for one or multiple influenza virus targets with clinical diagnostic tests for several days post vaccination. In order to confirm if co-detection of multiple influenza viruses in specimens collected from symptomatic patients is due to LAIV or co-infection of multiple wild-type (WT) viruses, state public health laboratories (SPHLs) are requested to submit such specimens to the CDC for diagnostic testing. Materials and Methods: Specimens received from SPHLs as positive for multiple influenza viruses were tested using the CDC Human Influenza Virus rRT-PCR Diagnostic Panel (CDC Flu rRT-PCR Dx Panel) as well as additional assays designed to differentiate LAIV and WT human influenza A and B viruses. Test results of samples received from 2010 until 2014 were analyzed to understand the relative prevalence over time of influenza virus co-detection due to LAIV and co-infection of WT influenza viruses. Results/Discussion: Since 2010, samples received from SPHLs for confirmatory testing due to co-detection of multiple influenza viruses were confirmed by rRT-PCR or genetic sequence analysis as either LAIV or co-infection of WT influenza viruses. Prevalence of LAIV detection was typically higher at the beginning of the influenza season when vaccination rates were higher and influenza circulation was low. Likewise, co-detection due to co-infection of WT viruses was more common during periods of high influenza activity when multiple influenza viruses were circulating. From 2014, CDC recommends LAIV for healthy children from 2 until 8 years of age when it is available. This recommendation may lead to higher rates of positive diagnostic influenza tests detecting LAIV resulting in possible misdiagnosis. Thus, it is important to consider vaccination history when interpreting positive influenza diagnostic test results, particularly early in the influenza season. Further, if positive test results are suspected to be due to LAIV, influenza may not be a causative agent for illness and testing for other pathogens should be considered. Presenter: Stephen Lindstrom, PhD, Team Lead, DDT/VSDB/ID/NCIRD, Centers for Disease Control and Prevention, 1600 Clifton Road NE Atlanta, GA 30333, Phone: 404.639.1587, Email: sql5@cdc.gov

P-38 Enhancing U.S. Influenza Virologic Surveillance and Virus Characterization through Collaboration with American Public Health Laboratories T. Wallis1, A. Foust1, W. Sessions1, E. Blanchard1, H. Hall2, S. Crenshaw3, P. Budhathoki4, J. Hung3, X. Xu1; 1Centers for Disease Control and Prevention, Atlanta, GA, 2McKing Consulting Corporation, Atlanta, GA, 3Atlanta Research and Education Foundation, Inc., Decatur, GA, 4Batelle, Atlanta, GA U.S. virologic surveillance data is essential for WHO and FDA to make annual influenza vaccine recommendations. American Public Health Laboratories (PHLs) are the foundation of the influenza virologic surveillance system in the U.S. Each year through collaboration with the Association of Public Health Laboratories (APHL), the Influenza Division of CDC, one of six WHO Collaborating Centers for surveillance, epidemiology and control of influenza, provides detailed virologic surveillance guidelines. In order to increase the number of influenza viruses characterized at CDC during an influenza season (October to May), the Influenza Division has contracted with state health department laboratories (California, Wisconsin, Utah, and Iowa) to receive, accession and propagate virus from specimens collected by PHLs, and then ship influenza virus isolates in sufficient volume to CDC for characterization. The number and percentage of U.S. specimens processed by these contract laboratories increased from 10% in 2009, when the collaboration was established, to 70% in 2014, allowing greater numbers of influenza specimens to be characterized by CDC in a timely fashion. Summaries of virus characterization during the influenza season are published weekly in FluView (http://www.cdc.gov/flu/weekly). FluView informs laboratorians, clinicians, media and the general public about the epidemiologic and virologic characteristics ( e.g., virus subtypes/strains, antigenic profile) of the viruses that are circulating in the U.S throughout the season, which is an integral part of the mission of the Influenza Division. The successful collaboration between CDC and the contract laboratories as well as APHLs over the last six years has improved virologic surveillance capacity in the U.S., and enabled timely analysis and reporting of greater numbers of characterized viruses than in previous years. Presenter: Teresa R. Wallis, MS, Health Scientist, VSDB/ID/NCIRD/CCID, Centers for Disease Control and Prevention, 1600 Clifton Rd. NE, MS G-16, Atlanta, GA 30333, Phone: 404.639.1687, Email: tcw1@cdc.gov

P-39 Development of Resources to Aid in the Implementation of Public Health Laboratory Competencies R. Ned-Sykes1, C. Johnson2, L. Gillis3, E. Perlman2 J. Ridderhof1; 1Centers for Disease Control and Prevention, Atlanta, GA, 2Association of Public Health Laboratories, Silver Spring, MD, 3Florida Department of Health, Miami, FL Objective: To develop tools and other resources to aid in the implementation of workforce competencies for laboratory professionals working in federal, state and local public health, environmental, and agriculture laboratories (henceforth defined as “public health laboratories” – PHLs). Project Design: CDC and APHL’s Workforce Development Committee led the creation of a preliminary set of resources to assist PHL directors, managers, scientists, and human resources staff with applying the public health laboratory workforce competencies (expected publication by June 2015), which are the result of a two and a half-year collaboration between CDC and APHL. A workgroup of professionals from CDC, state and local PHLs, and APHL convened January – May 2015 to select the resource products for the project and to develop templates and example documents. Results: The workgroup referenced resources for the Applied Epidemiology Competencies and the Core Competencies for Public Health Professionals to develop tools and resources such as example position descriptions, performance objectives, competency assessment forms, and career pathways based upon the PHL competencies. The resources address emergency management and response competencies as well as other topics. A pilot project is planned whereby three or more state/local PHL directors and managers will aim to implement these tools in their organizations. Based on feedback from this pilot implementation and further consultation with CDC, APHL members, and others, additional and revised resources will be developed. Conclusions: PHL professionals and organizations can use and customize the developed resources to aid them in adopting competency-based performance evaluation, workforce training, and other activities. Tools and other resources that support the implementation of the PHL competencies should bolster the integration of these competencies into workforce development activities and into public health laboratory practice. Presenter: Renée M. Ned-Sykes, MMSc, PhD, Health Scientist, OPHSS/CSELS, Centers for Disease Control and Prevention, 1600 Clifton Rd. NE, MS E-94, Atlanta, GA 30333, Phone: 404.498.0125, Email: rin1@cdc.gov

P-40 A Workshop to Improve Teaching Laboratory Competencies F. Downes, Michigan State University, East Lansing, MI The World Health Organization reports that 10.8% of adults in Mozambique are infected (1.6 million people) with the human immunodeficiency virus (HIV) and in 2012 there were almost 77,000 AIDS-related deaths in the population of 25.2 million making HIV/AIDS the leading cause of death. Large-scale anti-retroviral (ARV) treatment programs were initiated over a decade ago and 454,000 people were in treatment in 2013. Still two-thirds of the estimated 1.6 million HIV-infected population in Mozambique are not receiving treatment. One barrier to the success and expansion of ARV treatment programs is the capacity and capabilities of a robust laboratory network. The role out of ARV programs has finally lead health leaders to recognize the fragility and lack of resources in the laboratory network in Mozambique and other sub Saharan nations grappling with HIV treatment. The Maputo Declaration (WHO 2008) calls for strengthening laboratory systems in high HIV burden, low resource settings by among other strategies, strengthening laboratory human resources through pre-service education. The Association of Public Health (APHL), Michigan State University (MSU) and the Instituto Ciênsas de Saúde (ICS) partnered in developing and delivering a laboratory competency workshop for laboratory educators. The goal of the workshop was improvement of ICS teaching throughout the curriculum. The workshop content was based on the instructional design theory of Yellon et al. The language barrier between English-speaking workshop faculty and Portuguese-speaking participants was managed through MSU exchange students from Brazil acting as translators. A post-workshop evaluation indicated that the content was appropriate and well-organized and identified areas for improvement. However, the number of responses was too small for statistical significance calculation. The proposed workshop follow up includes determining the extent to which the workshop principles have been implemented by participants at ICS, MSU assisting ICS participants to deliver the workshop to other ICS faculty, and assessment of improved student learning. The workshop can be adapted and offered directly to other laboratory education institutions in other countries or US-based academic institutions or at multi-national meetings. Presenter: Frances Pouch Downes, DrPH, Professor, Biomedical Laboratory Diagnostics Program, Public Health Program, Michigan State University, 354 Farm Lane, Room N306, East Lansing, MI 48824, Phone: 517.884.4366, Email: downesf@msu.edu

P-41 The Virtual Lab Technician: How Two DNA Laboratories Use Automation to Increase Sample Processing Output by More than 40% H. MacIntosh1, T. Stacy2, B. Hoey3, M. Squibb4; 1STACS DNA, Ottawa, ON Canada, 2STACS DNA, Fairfax, VA, 3Missouri State Highway Patrol, Jefferson City, MO, 4Miami Valley Regional Crime Lab, Dayton, OH As public health labs increasingly incorporate molecular testing, they are faced with hiring or retraining medical lab technicians to perform DNA testing. Salaries, benefits and training add up to big recurring costs. There is an alternative: bar code readers, integrated instrumentation and specialized DNA sample processing software enable increased productivity at significant savings. This poster examines how two forensic DNA labs (with many similarities to public health labs) used technology to achieve substantial efficiencies without increasing staff. Lab Profiles: Missouri State Highway Patrol has three sites and processes 5,000 samples/year. Miami Valley Regional Crime Lab in Dayton, OH processes 2,500 samples/year. Previously, MSHP used Lotus Notes and MVRCL used Excel spreadsheets to track samples. Software & Technology: Both labs implemented STACS-CW Enterprise software, which delivers detailed sample processing workflows and controls designed specifically for DNA labs to save time, cut costs, improve documentation and prevent errors. Methodology: The labs completed a questionnaire that asked the time spent performing specific tasks before and after implementing STACS-CW Enterprise. Results: Prior to automating, the labs needed 19 and 10 DNA scientists, respectively, compared to only 13 and 4 afterwards; each lab saved the cost of hiring, training and paying 6 lab technicians. This represents a productivity increase of 46% and 150%, respectively. In essence, these labs have created “Virtual Lab Technicians” who work 24/7 without the need for salary or benefits. Conclusion:

• Many labs hire to address increasing workloads. • The right technology can multiply the productivity of a lab technician by more than 40%, thus creating a “Virtual DNA Lab Technician”. • Labs can effectively address their workload without hiring. • Technology costs may initially seem high, but the recurring costs of personnel will exceed technology investment.

• Each lab must establish the correct balance of technology and staffing to equip lab technicians to produce at their highest levels. • A combination of automation and technician experience enables a lab to best manage workloads and demanding TAT.

Presenter: Heather Macintosh, VP Sales and Marketing, STACS DNA, 2255 St. Laurent Blvd., Suite 206, Ottawa, ON K1G 4K3, Canada, Phone: 613.274.7822, Email: heather.macintosh@stacsdna.com

P-42 Review of State Reporting Requirements for Tuberculosis: A Case for More Uniformity M. Salfinger, J. Marola and S. Totten, National Jewish Health, Denver, CO Introduction: The Mycobacteriology Laboratory at National Jewish Health serves every state in the US and receives approximately 15,000 samples for both tuberculosis (TB) and nontuberculous mycobacteria (NTM) testing annually. This laboratory performs nucleic acid amplification testing (NAAT) testing on a 7-day per week basis. Our algorithm calls for reflex testing to a molecular multidrug resistant-TB (MDR-TB) screen on NAAT-positive specimens (respiratory, non-respiratory, paraffin blocks). As a reference laboratory, reporting of notifiable diseases must be done to all 50+ jurisdictions (JD). Methods: Websites from every state in the U.S., District of Columbia and New York City were searched for information about notifiable disease reporting for health care providers and laboratories. Results: All 50 states including the District of Columbia and New York City have reporting requirements for TB disease. However, reporting requirements vary significantly by JD. 85% of JD require reporting of positive AFB smears. The vast majority (53%; 28/53) of JD require reporting of a positive TB culture within 24 hours or within 1 business day of identification. The published timeframe for clinical reporting varies from immediately to up to 7 days or weekly. 23% (12/52) of JD require reporting of antimicrobial susceptibility testing results. However, no JD currently requires reporting of molecular drug resistance results. 69% (36/52) of JD require submission of the TB isolate to a state public health laboratory for further confirmation testing and inclusion of the isolate for nationwide genotyping. Electronic reporting is currently mandatory for 6 JD. Reporting of latent TB infection is required by 23% (12/52) of JD; some for only children <5 years of age. Thirteen (25%) JD require reporting of NTM. Conclusion: For reference laboratories such as National Jewish Health, the different requirements for reporting notifiable diseases are a real challenge. More uniformity would be more economic. As a potential solution, some jurisdictions put the burden of reporting onto the local submitting laboratory. However, as electronic reporting requirements become more prevalent, a systems approach is warranted rather than 50+ JD’s individual requirements. Such a systems approach will benefit interjurisdictional TB reporting as well.

Presenter: Max Salfinger, MD, Director, Mycobacteriology and Pharmacokinetics Laboratory, National Jewish Health, 1400 Jackson Street, Goodman Building, K412, Denver, CO 80206, Phone: 303.398.1339, Email: salfingerm@njhealth.org

P-43 Your Lab Gets All the Fun: High Throughput Sequence Processing in the Cloud H. Pouseele, D. Hollevoet and K. De Bruyne, Applied Maths, Sint-Martens-Latem, Belgium Problem: The quick advance of whole genome sequencing (WGS) in routine settings unveils the lingering bioinformatics problem of matching the speed at which data is generated with appropriate sequence processing power. Especially in small-scale labs without access to highly skilled bioinformaticians, the evolution towards WGS threatens to deprive microbiologists from first hand access to the knowledge hidden in their sequence data. Methodology: We present an easily accessible, cloud-based, high throughput environment for WGS data processing. Starting from raw sequence data uploaded to cloud storage, be it private, through BaseSpace or public such as NCBI, the data is processed with standardized and validated pipelines for whole genome multi-locus sequence typing (MLST) and whole genome single nucleotide polymorphism (SNP) analysis. This processing environment is deployed in the Amazon cloud, which allows for ultimate scalability: regardless of the number of samples, answers are provided within the hour (pending Amazon restrictions). Moreover, access to this high-throughput environment is fully integrated in the BioNumerics® software package, and requires nothing but an internet connection. Apart from its point-and-click user interface, this approach also allows to separate anonymous sequencing data and sensitive metadata: where experimental data is processed centrally, all metadata remains in local safety. Results: We illustrate the use of this calculation environment by analyzing an outbreak of Staphylococcus aureus in two Belgian neonatal care units. The polyphasic approach of, in increasing order of resolution, core genome MLST, whole genome MLST and whole genome SNPs gives a very complete image of this outbreak. Conclusions: The approach of a mixed local-central software model provides, while respecting data safety, a high-throughput calculation environment without burden on the local IT infrastructure. The integration with BioNumerics provides easy access from within a familiar environment, thus significantly lowering the thresholds for the use of WGS in routine applications. Presenter: Hannes Pouseele, Applications Architect, Applied Maths, Inc., Keistraat 120, 9830 Sint-Martins-Latem, Belgium, Phone: 32.9.2222.100, Email: Hannes_Pouseele@applied-maths.com

P-44 Quality System Management – The Next Level J. Havens and J. Poff, Qualtrax, Christiansburg, VA The State of Alaska Division of Environmental Health Laboratory (DECEH Lab) built a Quality Management System (QMS) based on multiple shared folders and paper files. As the volume of data grew and report requests became more complex, the system became cumbersome to manage; therefore the lab sought a comprehensive, easy-to-use compliance management system (CMS). Industry-leading vendors were evaluated, and Qualtrax was chosen based on customized system flexibility and functionality. With the new CMS from Qualtrax, QMS and compliance management efficiency and accuracy have increased. Qualtrax allows for flexible onboarding and the option to transition in stages which has made the process manageable. DECEH Lab now manages document control, employee testing of procedures and processes through an automated, traceable software solution. A new employee, for example, is assigned required training and testing based upon their position within the organization, and within Qualtrax he or she takes tests which are then tracked and documented to completion. This functionality facilitates compliance as the system documents staff acknowledgement that processes are understood and followed. Standard Operating Procedures (SOPs) are linked to training and a document trail is stored in Qualtrax. Another time saving automated workflow allows easy transfer of document management and responsibility when there are changes in responsibilities or staffing. As this occurs, all documents managed by the individual are listed and reassignments are processed automatically, avoiding the need to update each document individually. Qualtrax has been a game changer for the lab, taking their quality program to new levels. Quality Assurance staff experience efficiencies allowing them to focus on value added activities versus manual management of documents and process adherence. Managers now have the capability to pull reports relevant to their processes and lead accountability efficiently. Audit preparation and reporting time is at an all-time low as the associated workflow can be accessed utilizing a tablet, allowing for data collection directly into the report. Finally, the overall quality of managing compliance through the QMS is optimized and owned by the entire lab, enhancing the quality-focused culture throughout. Presenter: Patryce D. McKinney, MBA , Chief, Environmental Health Laboratory, Alaska SDWA Certification Authority, Alaska Department of Environmental Conservation, 5251 Dr. MLK Jr Ave., Anchorage, AK 99507, Phone 907.375.8200, email: patryce.mckinney@alaska.gov

P-45 Development of Phage Diagnostics for the Detection of Biowarfare Bacteria D. Schofield1, N. Sharp1, J. Vandamm1, D. Wray1, I. Molineux2; 1Guild BioSciences, Charleston, SC, 2University of Texas at Austin, Austin, TX Yersinia pestis and Bacillus anthracis are the etiological agents of plague and anthrax, respectively. In a terror event, these agents may be released as aerosols because they can be contracted via inhalation resulting in diseases that are usually fatal. Phage lysis assays using B. anthracis and Y. pestis specific phage are FDA-approved and used by the CDC and public health laboratories for confirmatory identification. These assays take advantage of a naturally occurring phage, which are specific and lytic for their bacterial host. After overnight growth on laboratory media, the presence of plaques (bacterial lysis) provides a positive identification. Although these assays are robust they suffer from two shortcomings: 1) they are laboratory based, and 2) require bacterial isolation and cultivation followed by an additional 24 h to complete. In order to overcome these deficiencies, our laboratory has developed recombinant “light-tagged” reporter phages that can rapidly and specifically detect B. anthracis and Y. pestis by transducing a bioluminescent phenotype. Reporter phages were generated by integrating the bacterial luxAB genes into a non-essential region of the phages genome through homologous recombination. The resulting reporter phages were able to confer a bioluminescent phenotype to B. anthracis or Y. pestis within 20 min of infection. Only viable, metabolically active cells were able to elicit a bioluminescent response. Non-anthracis Bacillus species and non-pestis Yersinia species did not generate a signal, or produced significantly reduced responses upon incubation with the reporter phage. Thus, the reporter phages display promise for the rapid and specific detection of B. anthracis and Y. pestis. Presenter: David Schofield, PhD, Chief Scientist, Guild Biosciences, Guild Associates, Inc., 5750 Shier-Rings Road, Dublin, OH 43016, Phone: 843.573.0095, Email: dschofield@guildbiosciences.com

P-46 Public Health Community Platform Proof of Concept Using the APHL AIMS Hub E. Haas1, E. Gonzalez Loumiet2, Frans de Wet2, Wesley Kennemore3; 1The St. John Group, Atlanta, GA, 2Uber Operations, LLC, Tallahassee, FL, 3Association of Public Health Laboratories, Silver Spring, MD The Association of State and Territorial Health Officials (ASTHO) designed the Public Health Community Platform (PHCP) as a cloud-based exchange where public health and healthcare are able to develop, compare and exchange interoperable solutions and allow access to common data sets upon which all types of analyses can be performed. The APHL Informatics Messaging Services (AIMS) platform meets many of the PHCP's goals and was chosen for a Proof of

Concept project which demonstrates the utility of the PHCP framework. The APHL’s AIMS Platform generated real time alerts triggered by the identification of reportable laboratory results in incoming laboratory reports. This basic decision support functionality can be enhanced and extended to many other use cases in Public Health, Environmental and Agricultural laboratories. The proof of concept demonstrates the potential for decision support tooling and advanced interoperability solutions. Increasingly, reporting laboratory information to various third parties involves newer messaging standards. Moreover there is a vastly increased amount of information being generated by laboratories today. Decision support is an important tool to collect, analyze and manage this information from a single or multiple sources. Requirements like these place an increasing burden upon laboratories and their limited IT resources. The benefits of a PHCP like the AIMS hub are many fold. By sharing resources and experienced vocabulary and messaging support, the development times and costs are reduced. Laboratories large and small gain access to the latest interoperability solutions and can eliminate gaps between programs. The AIMS platform also allows partner laboratories to easily share solutions. Presenter: Eric M Haas, Consultant, The St. John Group, Atlanta, GA, Phone: 707.227.2608, Email: ehaas@TSJG.com

P-47 Emerging Virus Discovery Through Meta-transcriptomics: A Novel Virus Impacting Rainbow Trout Farming in Chile E. Castro-Nallar1,2, D. Toro-Ascuy3, S. Reyes-Cerpa3, K. Crandall1, A.M. Sandino3, E. Spencer3, M. Cortez-San Martin3; 1The George Washington University, Ashburn, VA, 2Aperiomics, Inc., Ashburn, VA, 3Universidad de Santiago de Chile, Santiago, Chile Viral pathogen discovery is critically important to clinical microbiology, infectious diseases, and public health. During 2012-13 there was an outbreak of unknown etiology affecting farmed rainbow trout (Oncorhynchus mykiss) in southern Chile. Clinical inspection and conventional diagnostic methods (PCR, cell and bacterial culture, immunofluorescence) failed to detect any known infectious agents, and transmission microscopy micrographs suggested the presence of viral particles in many organs. Here we present the results of a meta-transcriptomics analysis of two infected individuals and one control on spleen, muscle, heart, and brain tissues. Using high-throughput sequencing and our PathoScope pipeline on rRNA depleted Total RNA preparations, we found the presence of a new salmonid alphavirus described for the first time in Chile. In addition, we were able to provide insights into its relationship to other salmonid alphaviruses as well as to its within-host genetic diversity among infected organs. This study demonstrates the utility of high-throughput sequencing and novel computational techniques to the study of emerging infectious agents in animal production. Presenter: Crystal R. Icenhour, PhD, CEO, Aperiomics, 45085 University Dr., Suite 305, Ashburn, VA 20147, Phone: 434.293.2960, Email: cicenhour@aperiomics.com

P-48 Associations Working to Increase the Number of Accredited Governmental Food and Feed Testing Laboratories for an Integrated Food/Feed Safety System Y. Salfinger1,2, K. Larson1, N. Thiex3; 1Association of Public Health Laboratories, Silver Spring, MD, 2Association of Food and Drug Officials, Denver, CO, 3Association of American Feed Control Officials, Brookings, SD The Food Safety Modernization Act (FSMA) provides the US Food and Drug Administration (FDA) with provisions to achieve better public health protection and improve the food safety system. The Partnership for Food Protection (PFP) was created to ensure collaboration among federal, state and local entities and to formulate standards that can be used nationally to ensure uniformity of inspection and laboratory procedures and expand foodborne outbreak response capacity. The national standards together with laboratory accreditation are expected to allow the seamless use of laboratory analytical data across federal, state and local jurisdictions in response to outbreaks and the rapid acceptance of such data for regulatory actions. In 2012, FDA funded three national organizations (the Association of Public Health Laboratories, the Association of Food and Drug Officials, and the Association of American Feed Control Officials) to prepare government food and feed regulatory testing laboratories seeking to achieve, maintain, and enhance ISO/IEC 17025:2005 accreditation. These associations strengthen multi-disciplinary laboratory collaboration, develop training and mentoring programs, improve direct electronic sharing of analytical data, and build a framework for unified laboratory response. Activities and resources are provided to laboratories to strengthen their ability to achieve and maintain accreditation. Presenter: Yvonne Salfinger, MS, 1488 Madison Street, #501, Denver, CO 80206, Phone: 904.233.6710, Email: yhale@aol.com

P-49 Local Laboratory Committee (LLC) - Who We Are & What We Do B. Van, Marion County Public Health Laboratory, Indianapolis, IN The LCC will be promoting the Public Health Institutional – Local member community by reflecting on the projects that they’ve recently completed and reviewing the committee’s objectives fort the coming years. The list below provides some insight into the information that will be provided:

• Definition of a Local PHL • APHL Public Health Institutional - Local Member list • How to become a local lab member and who to contact for more information • LLC’s current and future projects/objectives • Committee contact information • Local Lab Luncheon information • Promoting posters at the Annual Meeting being presented by local lab members • Highlight Local Lab projects and publications Presenter: Bobby Lewis Van, PhD, FACB, HCLD(ABB), Laboratory Director, Marion County Public Health Department, 3838 N Rural St., Indianapolis, IN 46205, Email: bvan@marionhealth.org

P-50 The Laboratory Response Network for Biological Threats Preparedness (LRN-B) Reconfiguration T. Wolford and C. Mangal, Association of Public Health Laboratories, Silver Spring, MD In 1999, through a collaborative effort between the Centers for Disease Control and Prevention (CDC), the Federal Bureau of Investigation (FBI), and the Association of Public Health Laboratories (APHL), the Laboratory Response Network (LRN) was founded. The LRN provides an infrastructure of more than 1500 local, state, and national public health laboratories tasked with delivering high quality laboratory testing on biological, chemical, and radiological threat agents. The LRN for Biological Threats Preparedness (LRN-B) has been instrumental in responding to public health threats such as the anthrax attacks of 2001, outbreaks of H1N1 and SARS, and more recently has been leveraged to respond to emerging threats such as Ebola. In order to maintain and improve these capabilities, while dealing with impacts on funding, the LRN is exploring more effective and efficient ways to organize and utilize the network. In 2013, founding partners began reconfiguring the LRN-B structure to broaden coverage across the network, strengthen laboratory relationships, and increase laboratory capabilities. The reconfiguration will also institute well-defined capabilities for all laboratories within the network in order to expand capabilities for surge capacity, biosurveillance, and emerging infectious disease. By evaluating these current needs and evolving to meet them, the LRN-B will remain sustainable and provide a strong presence in laboratory preparedness and response. Presenter: Tyler Wolford, MS, Specialist, LRN, Association of Public Health Laboratories, 8515 Georgia Ave., Suite 700, Silver Spring, MD 20910, Phone: 240.485.2775, Email: tyler.wolford@aphl.org

P-51 Your Pit Crew Needs These Tools in the Race Against Foodborne Disease Outbreaks K. Larson1, D. Boxrud2, R. Atkinson3, D. Patel4, S. Shea1; 1Association of Public Health Laboratories, Silver Spring, MD, 2Minnesota Department of Health, St. Paul, MN, 3Utah Public Health Laboratory, Taylorsville, UT, 4Council of State and Territorial Epidemiologists, Atlanta, GA Background: The Council to Improve Foodborne Outbreak Response (CIFOR) is a multidisciplinary group comprised of laboratorians, epidemiologists, and environmental health specialists across all levels of government. CIFOR was created to develop and share guidelines, tools and products that will facilitate good foodborne outbreak response. Methods: CIFOR recently developed several tools and products to evaluate program performance, enhance collaboration among stakeholders, and provide model practices in foodborne outbreak investigation. CIFOR projects are submitted to the Council for approval and must align with CIFOR’s vision and mission. CIFOR member-led work groups provide a well-rounded perspective to foodborne outbreak product development. Results: The 2nd Edition of the CIFOR Toolkit is intended to walk public health practitioners through recommendations in the Second Edition of the CIFOR Guidelines for Foodborne Disease Outbreak Response. Users work through twelve interactive focus areas aimed at identifying current practices, strengths and gaps that can be addressed through recommendations contained in the Guidelines. Outbreaks of Undetermined Etiology (OUE) Guidelines provide recommendations on the collection, shipment and storage of foodborne outbreak specimens based on syndromes and specific outbreak profiles. The OUE Guidelines are designed to provide adequate specimens for second-tier testing and pathogen discovery should the etiology prove elusive. The CIFOR Metrics Tool is an interactive, web-based version of the Development of Target Ranges for Selected Performance Measures in the CIFOR Guidelines released in April 2014. Users provide data on sixteen performance measures in order to evaluate performance of their foodborne disease surveillance, outbreak investigation, and control programs and identify specific needs for improvement. Conclusions: Jurisdictions will be able to identify programmatic strengths and weaknesses using CIFOR foodborne outbreak investigation tools and products. Broad implementation of these tools will contribute to CIFOR’ s goals to better detect, investigate, respond to and control foodborne outbreaks in the United States. Presenter: Kirsten Larson, Manager, Food Safety, Association of Public Health Laboratories, 8515 Georgia Ave., Suite 700, Silver Spring, MD 20910, Phone: 240.485.2759, Email: kirsten.larson@aphl.org

P-52 Outcomes of Foundation in Laboratory Leadership and Management (FLLM) Strengthen Managers at the National Health Laboratory Services (NHLS) in South Africa K. Lewis1, K. Shen2, S. Liska2, J. Plaatjes3, P. Dabula3, Z. Cele3, T. Molelle3, A. Adelekan4; 1Association of Public Health Laboratories, West Cape, South Africa, 2Association of Public Health Laboratories, Silver Spring, MD, 3National Health Laboratory Services, Johannesburg, South Africa, 4Centers for Disease Control and Prevention South Africa, Pretoria, South Africa The Association of Public Health Laboratories (APHL) is a CDC/PEPFAR partner assisting in the provision of sustainable programs and improved quality laboratory services through various mechanisms. Since 2006, APHL has provided the FLLM workshops in 14 countries, including South Africa. The NHLS provides clinical laboratory service to the public sector, serving over 80% of the South African population through a countrywide network of 268 laboratories. It is important to measure the impact of outcomes from management trainings, including knowledge gained and the value added to lab services. During 2014, APHL conducted 4 sessions of one-week FLLM workshop for laboratory Managers and Supervisors employed by the NHLS in South Africa. During the workshop, each participant identified three activities to be implemented at their respective laboratories over a 6 week period. The activities were chosen from the FLLM curriculum modules which covered the following areas: Organizational Structure and Management, Manager vs. Leader, Human Resources, Communication and Conflict Resolution, Team Leadership, Problem Solving and Decision Making, Financial Management, and Strategic and Operational Planning. In addition, all participants worked collaboratively to produce a current national environmental SWOT analysis of laboratory services within the NHLS. All participants completed a pre and post-test. Out of 111 participants, 101 (91%) completed their activities. A total 0f 306 out of 328 (93%) activities were completed. Knowledge improvement or gained from pre and post evaluation was 12%. A comprehensive breakdown of the activities per curriculum module will be provided. The FLLM assisted improved managerial competence and confidence of NHLS laboratory supervisors as shown by their ability to successfully complete managerial tasks at their respective workplace. The activities completed will provide notable improvement in general laboratory management skills, effective and efficient utilization of resources, and workflow of processes. These important skills and tasks assist in provision of improved quality laboratory services and accreditation preparedness. The inclusion of post workshop activities provided an opportunity for managers to apply their newly obtained knowledge at the workplace. Presenter: Kim Lewis, MSc, APHL Senior Laboratory Consultant, PO Box 95, Pringle Bay, Western Cape 7196, South Africa, Phone: 27.73.2499201, Email: kimlewis8@yahoo.co.uk

P-53 Through Partnership and Collaboration, a New Program that Provides Training Opportunities for Emerging Laboratory Leaders in Lesotho K. Shah1, K. Lewis2, L. Maryogo-Robinson1, S. Staley1, P. Ray1; 1Association of Public Health Laboratories, Silver Spring, MD, 2Association of Public Health Laboratories, Lesotho Background: The Association of Public Health Laboratories (APHL) in collaboration with the Lesotho Ministry of Health (MOH) implemented a pilot program to assist medical laboratory managers and supervisors to enhance their leadership and management skills. This pilot mirrors the US based Emerging Leader Program and utilizes alumni as coaches to further professional development of Lesotho participants. Methods: Workshops, projects of national impact, team building and a coaching program were introduced to 10 participants over the course of 6 months. Workshop modules included project management, strategic planning, effective communications, and change management. The cohort worked on two capstone projects: one addressed critical Human Resource challenges of a lack of discipline-specific laboratory personnel; the other project addressed inventory challenges in the procurement process. Results: The two teams presented 1)a Proposal with recommendations to the MOH for the increase of specialized Laboratory Human Resource and 2) a Report analysing delays in the procurement process that leads to testing service interruption. Coaching sessions between the Cohort members and Alumni of the US ELP were also established to further support the professional growth and network of these emerging leaders. Conclusions: These individuals are the future leaders in the medical laboratory services of Lesotho. By addressing the challenges of workforce issues, effective communications with stakeholders and other strategic management related issues, they are prepared to complete assignments and engage in group activities as well as embrace their personal evolution as leaders. This program is an innovative example for other countries and their Ministries to follow and will create highly competent managers in their respective countries. By collaborating with APHL to build a laboratory leadership program, countries can prospectively develop their next generation of laboratory leaders to effectively address current challenges within their medical laboratory community. Presenter: Kajari Shah, Manager, NCPHLL, Association of Public Health Laboratories, 8515 Georgia Ave., Suite 700, Silver Spring, MD 20910, Phone: 240.485.2725, Email: kajari.shah@aphl.org

P-54 The Process of Establishing a National Public Health Laboratory in a Developing Country: Lessons Learned from Namibia H. Habib, Association of Public Health Laboratories, Silver Spring, MD APHL’s Global Health Program is supporting efforts to build Namibia’s first National Public Health Laboratory. APHL consultants from HDR Architecture, Inc. (HDR, Inc.), whom have lab design expertise, have collaborated with the Namibia Ministry of Health and Social Welfare, and Namibian team of architects and engineers from Barnard Mutua Architects and Burmeister & Partners Ltd. to design the new lab which will be built in Okahandja, Namibia. This poster will examine the parties, process, and challenges involved in the establishment of the laboratory. Process: First Phase: Open Dialogue and Review • HDR, Inc., began open dialogue with local architects and engineers to help understand the local building practices. • Reviewing aspects of the design early on to inform the design and accurate cost estimate. Second Phase: Basis of Schematic Design (BOD) • HDR, Inc., developed the BOD for a new building to house the National Public Health Laboratory to be used as follows: • to inform a cost estimate; • in support of obtaining additional funding for the facility and finalization of a plan for equipment, human resource development, and technical assistance; • as a platform by which a local architect can develop a more detailed design and documents for construction. Third Phase: Design Development • In September 2014, HDR, Inc., met with APHL and representatives from the Namibia CDC and Ministry of Health to review project progress. • They also met with the local Namibian architecture, engineering and planning team to coordinate building systems development and progress of the documents. • And all parties participated in laboratory tours of the Virginia DCLS and DC Public Health Laboratory facilitated by APHL. • HDR prepared conceptual floor plan diagrams reflecting the spaces indicated on the previously prepared space list and updated the space list as required. Fourth Phase: Lab Design HDR, Inc. provided detailed technical information regarding the Lab Design, incorporating partner perspectives from previous lab planning workshops for the project to develop the preliminary and final designs. Challenges: To be included later. Conclusion: Analysis of this process may serve as a best practice for other countries working to establish their own national public health laboratory. Presenter: Haroun Habib, Senior Specialist, Global Health, Association of Public Health Laboratories, 8515 Georgia Ave., Suite 700, Silver Spring, MD 20910, Phone: 240.485.2748, Email: haroun.habib@aphl.org

P-55 Development of Indicators for Monitoring and Evaluation of Public Health Laboratory Systems M. Paz Carlos and M. Evans, APHL Global Health Committee, Silver Spring, MD The development of high-performing indicators permits laboratories to measure, track and understand public health laboratory system programmatic performance. These may be at the operational level e.g. inputs such as service delivery, outputs like the status of program implementation, processes, as well as the strategic level, e.g., objectives and intermediate results. The development of indicators must be useful to the management for monitoring and evaluation. Initially, the development of meaningful indicators is based on the informational needs to support the strategic and operational decision-making process and to assist in reporting as well as communicating to agency counterparts. It is essential to design and develop indicators by identifying a data collection instrument focusing precisely on the needed information, and not on the collected data. One should initially identify the informational needs, followed by the indicators, and with this information, one would develop a data collection instrument or tool. Here are selected indicators for a global public health laboratory systems including the Laboratory Information Systems (LIS) and Communicable Diseases Surveillance. The selected indicators for the LIS include: (1) Management report preparation time in minute/hour to measure time used to generate manual reports vs LIS based management reports; (2) Number of power failures per month to measure delivery of essential energy services; (3) LIS downtime during normal operational hours to measure LIS operational functionality; and (4) Data entry and specimen accessioning transcription error rate/number of transcriptional errors per month to measure specimen accessioning accuracy. While, the selected Indicators for Communicable Diseases Surveillance include: (1) Test specific turn-around-time (TAT) to measure service delivery indicators such as key test TAT; (2) Number of revised reports/month to measure clinically significant lab results changed such as accuracy of testing; (3) Electronic patient report delivery time versus manual report delivery time e.g. HIV to measure a process indicator (electronic versus manual patient report delivery time); and (4) % AFB smears resulted within 24 hour of laboratory receipt to measure the service delivery indicator (key test TAT). Presenter: Maria Paz Carlos, PhD, Virology and Immunology Division Chief, Maryland State Dept. of Health and Mental Hygiene, Laboratories Administration, 201 West Preston Street, Baltimore, MD 21201, Phone: 410.767.6151, Email: maria.carlos@maryland.gov

P-56 Strengthening and Sustaining Laboratory Systems in Resource Limited Settings M. Evans1, M. Paz Carlos2; 1Association of Public Health Laboratories, Silver Spring, MD, 2Maryland Public Health Laboratory, Baltimore, MD In resource-limited countries, there is often minimal laboratory testing primarily due to few qualified testing personnel, limited funding, distant training, minimum LIS capability and functionality, few IT software engineers with laboratory workflow knowledge, and a lack of understanding of operational efficiencies. Too often the current outcome is insufficient or delayed reporting of test results thereby impacting patient care. A strategic developmental approach to improving the delivery of PHL testing services includes enhancement and strengthening capacities as well as the standardization of critical laboratory systems. For enhanced delivery of PHL testing services, strategies include: (1) establishment of LIS shared services (harmonization of databases and utilization of standardized interfaces); (2) implementation of operational efficiencies (workflow mapping with the elimination of non-value added steps); (3) standardization of testing platforms, interfaces, databases and SOPMs; (4) effective project management; and (5) establishment of global PPPs. National priorities, funding, and human resources will be the basis for project selection. Feasibility, cost benefit, and sustainability are primary factors in decision-making. Multinational purchasing agreements with LIMS vendors or instrument manufacturers would help reduce the cost, promote knowledge transfer, focus resources and avoid redundancies. While many countries have strategic plans in place or under development, implementation and project completion are often challenging. An efficient organizational structure, ownership at high levels and strong project management are requirements for success. A national Executive Management Team could serve as a cross-functional group comprised of senior leadership, primary stakeholders, and partners. Each selected initiative, e.g. establishing a national specimen transportation program, would consist of a Project Management Team providing oversight to Technical Workgroups. A three-tiered approach promotes shared accountability, essential collaboration, interoperability, and harmonization resulting in the generation and analysis of laboratory testing services data for strategic decision-making towards a strengthened and sustainable system. Presenter: Martin R. Evans, PhD, CLT, MT(ASCP), Senior Laboratory & Informatics Consultant, Association of Public Health Laboratories, 8515 Georgia Ave., Suite 700, Silver Spring, MD 20910, Phone: 631.923.1506, Email: martinevans1723@gmail.com

P-57 Withdrawn

P-58 APHL Informatics Messaging Services (AIMS): a Platform for Public Health Data Exchange W. Kennemore1, E. Gonzalez Loumiet2; 1Association of Public Health Laboratories, Silver Spring, MD, 2Uber Operations, LLC, Tallahassee, FL The ability to share data efficiently and securely with diverse messaging partners is a critical capability for public health laboratories (PHLs), however it is often difficult for PHLs to accommodate ever-changing transport mechanisms. The current age of cloud computing and global hacking presents PHLs with incredible opportunities and constant security concerns. APHL has developed APHL Informatics Messaging Services (AIMS) to help lead PHLs forward in this new age. AIMS began as a message transport hub with the ability to receive, route and transmit electronic messages sent to/from any stakeholder connected to the hub. While the hub still provides this important functionality, AIMS has grown to become a highly secure, multiservice platform facilitating data exchange between hospitals, providers, public health laboratories, public health jurisdictions and CDC. These expanded services are in response to member concerns over the arduous maintenance of point-to-point electronic interfaces and the burden of meeting new regulatory requirements, as well as the lack of direct incentive funding for Meaningful Use adoption. By migrating AIMS to a certified and compliant cloud environment, APHL was able to enhance the hub’s security structure and expand the suite of services offered to PHLs to include interoperability between multiple transport protocols and translations/transformation of message formatting. AIMS also hosts applications to exchange immunization data and filter ELR data streams. The enhanced AIMS platform complies with the Health Insurance Portability and Accountability Act (HIPAA), the Federal Risk and Authorization Management Program (FedRAMP), the Federal Information Systems Management Act (FISMA) and other common security control protocols. These upgrades facilitate more efficient and effective failover, more efficient operations and reduced operating costs. This poster reviews the history and evolution of AIMS. It describes the services that AIMS now offers to APHL members and summarizes some of the exciting pilot projects underway that will continue to augment the capabilities of the AIMS platform. Presenter: Wes Kennemore, MD, MS, PE, Manager, Health Information Technology, Association of Public Health Laboratories, 8515 Georgia Ave., Suite 700, Silver Spring, MD 20910, Phone: 205.837.3819, Email: wes.kennemore@aphl.org

P-59 The Future of Data Exchange at Food and Feed-Testing Laboratories D. Shirazi1, T. Phillips2, B. Sauders3, J. Cook4, B. Furlano5, B. Keavey6, B. Sheridan3, V. Holley7, M. Kourbage8; 1State Hygienic Laboratory at University of Iowa, Coralville, IA, 2Maryland Department of Agriculture, Annapolis, MD, 3New York State Department of Agriculture and Markets, Albany NY, 4Florida Department of Agriculture and Consumer Services, Tallahassee, FL, 5Minnesota Department of Agriculture, St. Paul, MN, 6Gus R. Douglas Agricultural Center at Guthrie, Charleston, WV, 7Association of Public Health Laboratories, Silver Spring, MD, 8J. Michael Consulting, Atlanta, GA Background: Data Exchange presents both opportunities and challenges for all public health laboratories and agencies. It is difficult to keep pace with changing information technology and messaging standards in any industry. Food and feed-testing laboratories have the added burden of coordinating the needs of a diverse client base while also complying with regulatory requirements from multiple jurisdictions at the local, state and federal level. Managing data and reporting to these multiple stakeholders is a critical function of the laboratory but also an ongoing challenge. Moreover, efficient and interoperable data exchange is a key component of an integrated food safety system and long-term surveillance of foodborne disease outbreaks. Methods: The Food and Drug Administration (FDA) assembled the National User Group, which consists of data exchange experts from various state laboratories, as a forum for discussing strategies to strengthen the informatics capabilities in food and food-testing laboratories. Results: This poster is a collaborative effort by the National User Group, the Association of Public Health Laboratories (APHL), and FDA. It delineates the key informatics issues facing food and feed-testing laboratories and reviews the best practices within these laboratories, with the understanding that the needs of each individual laboratory varies by testing volume, available resources, existing technical infrastructure and reporting requirements. Conclusions: The insights of the National User Group will help food and feed-testing laboratories plan a path forward in terms of developing their informatics capabilities to collect, store, and share data with state and federal partners. Presenter: Vanessa Holley, Senior Specialist, Informatics, Association of Public Health Laboratories, 8515 Georgia Ave., Suite 700, Silver Spring, MD 20910, Phone: 240.485.2755, Email: Vanessa.holley@aphl.org

P-60 The Knowledge Retention Toolkit L. Kurimski1, T. Theisen2, M. McCann3, B. Wilcke4, B. Juni5, J. Ridderhof6, D. Kim5, S. Daher5; 1State Hygienic Laboratory at the University of Iowa, Coralville, IA, 2Saginaw County Department of Public Health Laboratory, Saginaw, MI, 3Minnesota Department of Health, St. Paul, MN, 4University of Vermont, Burlington, VT, 5Association of Public Health Laboratories, Silver Spring, MD, 6Centers for Disease Control and Prevention, Atlanta, GA Objective: As the laboratory workforce transitions and turnover rates increase, there is a need to capture the information and knowledge of those departing a position. The Knowledge Management Committee tried to address that need by developing “The Knowledge Retention toolkit”. Project Design: The Knowledge Retention toolkit provides PHLs with a model to capture and retain explicit and tacit knowledge (information) within their organization. The toolkit includes components such as: knowledge management lists, interactions, committees and projects, and daily operations; exit interview; and an on-boarding plan. Results: This poster will outline how PHLs can apply the toolkit to departing staff, key personnel whose unpredicted absence could cause a significant impact on operations, and staff who are on an extended leave of absence. The knowledge obtained can be used to assure continuation of critical activities or as guidance for building an on-boarding plan for a new replacement. Also a display of key elements of an on-boarding plan, including administrative essentials such as orientation, documentation, and training; notifications and professional interactions; transition of responsibilities; and assessment of progress are included. Conclusions: The toolkit is designed to capture at-risk and critical knowledge that is specific to organizational performance and decision-making. Information captured and retained also provides PHLs with insight on what is going well as well as opportunities for improvement as well as assist those who come in to the new position. Presenter: Lorelei Kurimski, MS, CLM, Director, Office of Organizational Development, State Hygienic Laboratory at the University of Iowa, University of Iowa Research Park , 2490 Crosspark Road, Coralville, IA 52241-4721, Phone: 319.335.4979, Email: lorelei-kurimski@uiowa.edu

P-61 Action through Change: Effective Process Improvement (PI) Teams L. Kurimski and R. Greenberg, State Hygienic Laboratory at the University of Iowa, Coralville, IA The Problem: Process Improvement can be challenging without a clear method of improvement, progress towards specific actionable steps, and measuring the changes in performance. Teams leading process improvement can also be challenged with conflicting

priorities, lack of clear vision or standardized structure, and failure to capitalize on the benefits of cross-functional teams and organizational subject matter experts. Methodology: Application, lessons learned, and team member feedback from over forty process improvement teams and strategic workgroups were compiled over a two year period and collection of best practices were developed as guidance to support effective process improvement teams. In this poster we will share a summary of these including key team steps for improvement that follows the standardized DMAIC cycle. The poster will also cover the tools and approaches that will allow teams to move from ideas into action, including how to how to build and onboard a team, manage team knowledge, track investment, support engagement, and measure improvements. A handout will be available on common team tools that support consensus such as the affinity diagram, interrelationship diagraph, Hot Dot, and consensograms. Conclusions: Developing effective process improvement action plans using a team-based approach is critical to ensure PHLs meet and support the Eleven Core Functions. As demands for public health/public health laboratory services change, there remains a need to maximize process improvement teams to support improvement to programs and services, address day-to-day business operations, and align with strategic planning. Developing a standardized method to support process improvement teams is vital to ensure successful management of organizational knowledge, maximize resources, capitalize on opportunities for improvement, effectively manage time, and support successful outcomes. Presenter: Lorelei Kurimski, MS, CLM, Director, Office of Organizational Development, State Hygienic Laboratory at the University of Iowa, University of Iowa Research Park , 2490 Crosspark Road, Coralville, IA 52241-4721, Phone: 319.335.4979, Email: lorelei-kurimski@uiowa.edu

P-62 Relocating a Laboratory: Wisdom of the Community V. Waddell1, J. Bennett2, M. Celotti3, L. Kurinski4, B. Juni5, D. Kim5, S. Daher5; 1Arizona State Public Health Laboratory, Phoenix, AZ, 2Connecticut Department of Public Health Laboratory, Rocky Hill, CT, 3Vermont Public Health Laboratory, Burlington, VT, 4State Hygienic Laboratory at the University of Iowa, Coralville, IA, 5Association of Public Health Laboratories, Silver Spring, MD Objective: Many public health laboratories are faced with the challenging task of moving facilities and face difficulty in figuring out what to do. The Knowledge Management Committee (KMC) compiled information pertaining to the move and developed a guide to assist laboratories who are faced with this task. Project Design: Your Public Health Laboratory (PHL) will be moving to a new facility. Great! Now what? Planning the move of a PHL to another facility is an enormous task with many unique factors affecting the process. In the interest of the public’s health, quality testing and operations must continue without significant interruption or delays. Facilities, equipment, and

storage all need to be in optimal working condition during a move and often in more than one location. Results: Creating an all-encompassing plan for relocation can feel daunting. The Guide to Moving Laboratory Facilities was compiled by laboratory members who have experience with relocation. This guide can assist you and your laboratory’s leadership in the various phases of a move, from pre-move planning, coping during the move and post-move considerations. Conclusion: This guide will ease the challenge of moving facilities as well as provide detail information of issues to consider for a successful move. Presenter: Sadira Daher, MA, Senior Specialist, Quality Systems, Institutional Research, Association of Public Health Laboratories, 8515 Georgia Ave., Suite 700, Silver Spring, MD 20910, Phone: 240.485.2702, Email: sadira.daher@aphl.org

P-63 APHL Listservs: Your Community Resource S. Daher1, B. Juni1, T. Theisen2, J. Bennett3, R. France4, M. Lachica5, R. Rej6, B. Wilcke7, M. Celotti8, M. Chan9, R. Gautom10, M. McCann11, S. Mehta12, V. Waddell13, D. Xia14, D. Kim1, L. Kurimski15; 1Association of Public Health Laboratories, Silver Spring, MD, 2Saginaw County Department of Public Health Laboratory, Saginaw, MI, 3Connecticut Department of Public Health Laboratory, Rocky Hill, CT, 4Florida Bureau of Public Health Laboratories, Tampa, FL, 5Long Beach Public Health Laboratory, Long Beach, CA, 6New York State Department of Health, Albany, NY, 7University of Vermont, Burlington, VT, 8Vermont Public Health Laboratory, Burlington, VT, 9Florida Department of Health, Jacksonville, FL, 10Washington State Department of Health, Shoreline, WA, 11Minnesota Department of Health, St. Paul, MN, 12Rutgers University, Newark, NJ, 13Arizona State Public Health Laboratory, Phoenix, AZ, 14California Department of Public Health Laboratory, Richmond, CA, 15State Hygienic Laboratory at the University of Iowa, Coralville, IA Objective: The first Listserv was developed in 1984 and used an IBM Mainframe to forward an email to a list of subscribers. Putting into practice the same concept, the APHL listserv is the association’s email distribution system which allows subscribers to discuss and exchange information relevant to the forum topic. Given that there are numerous APHL’s listservs, the KMC pulled all the active listservs to provide an organized chart of them. Project Design: The KMC gathered all the active APHL’s listservs to display them in an organized manner. The chart provides the listserv forums; the description of the interest; the audience directed to; the sign up contact; and relevant links. This chart not only depicts all the current listservs but serves as a way to promote its participation and increase awareness of its existence. Results: There are currently fourteen forums with topics ranging from Microbiology and Environmental Laboratory, to Newborn Screening, to Quality Assurance. APHL’s listserv discussions include state public health laboratory practice and policy; laboratory methods; common management concerns; laboratory surveillance testing; quality assurance and, current

laboratory news. Many of the forums are open to all APHL members but some, such as the Laboratory Director forum, have limited access to provide for “private” discussion. Conclusion: By participating in the APHL Listserv, members are able to share questions and receive replies from peer members that have specific knowledge about the subject or to generate discussions with those who have a like interest Presenter: Sadira Daher, MA, Senior Specialist, Quality Systems, Institutional Research, Association of Public Health Laboratories, 8515 Georgia Ave., Suite 700, Silver Spring, MD 20910, Phone: 240.485.2702, Email: sadira.daher@aphl.org

P-64 The Evaluation of PHL Sustainability Resources S. Daher1, T. Moulton2, R. Ned-Sykes2, K. Breckenridge1, J. Ridderhof2; 1Association of Public Health Laboratories, Silver Spring, MD, 2Centers for Disease Control and Prevention, Atlanta, GA Objective: APHL and CDC have continued to work toward Public Health Laboratory (PHL) sustainability since the renaming of what was previously known as the Laboratory Efficiencies Initiative (LEI) in 2014. Current PHL sustainability work incorporates the evaluation of resources that were released under the LEI in 2012, 2013 and 2014, including: • The State Public Health Laboratory Billing: Status Report and Recommendations, which presents an overview of current PHL billing capacity and examples of successful PHL billing processes; • The Policy Guide for Public Health Laboratory Test Service Sharing, which is for use by PHL directors and their colleagues as they explore legal and other policy questions related to interstate sharing of test services by PHLs; and • A Practical Guide to Assessing and Planning Implementation of Public Health Laboratory Service Changes, which is a resource for assessing and planning laboratory changes to strengthen the public health laboratory system. Methodology: A survey for each of the three listed resources was developed by APHL and sent to PHL directors to measure the overall usefulness of each guide and to gather recommendations for improvement. The surveys were designed to solicit feedback on how the guides were used, whether the guides helped in the process of making changes within the laboratory, what was most and least helpful about the guides, and what types of information should be included in updated versions. APHL analyzed the results of the surveys and is in the process of preparing recommendations regarding the development of updated guides. Results: Summaries of the data collected from the impact surveys will be presented. Since the surveys were being prepared to be fielded at the time of abstract submission, no data are currently available. Information anticipated from the surveys includes the extent the tools were used, summaries of that usage, suggestions for improvement, as well as ideas for future tools. To date, informal feedback on these resources has been positive. Conclusions: PHL sustainability continues to be a priority for APHL and CDC. Previously released resources have been evaluated to document how they were used and solicit suggestions for

future tools and aids. The information collected will help mold future PHL sustainability activities. Presenter: Sadira Daher, MA, Senior Specialist, Quality Systems, Institutional Research, Association of Public Health Laboratories, 8515 Georgia Ave., Suite 700, Silver Spring, MD 20910, Phone: 240.485.2702, Email: sadira.daher@aphl.org

P-65 The Public Health Laboratory System Database: Findings from Pilot Implementation D. Kim1, K. Breckenridge1, J. Ridderhof2, R. Ned-Sykes2, S. Adebola2, S. Daher1; 1Association of Public Health Laboratories, Silver Spring, MD, 1Centers for Disease Control and Prevention, Atlanta, GA Objective: The Public Health Laboratory System Database (PHLSD) was developed for APHL by Booz Allen Hamilton to improve management of public health laboratory (PHL) data and information. Each PHL will have their own database to manage on their laboratory’s infrastructure, regulatory compliance, testing capability and equipment. The database’s reporting functionality will allow PHLs to: prepare for inspections by accrediting and certification agencies; have an updated list of tests and methods; and have access to an electronic equipment inventory. The data will enable creation of a national PHL test directory by APHL and make detailed test capability information available to PHLs in public health emergencies, during surge capacity needs, for exploring potential sharing of test services, and for identifying the test service expertise of PHLs. Methodology: The PHLSD pilot included a subset of PHLs that are members of regional consortia. The submitting laboratories were asked to enter their complete test and equipment information, providing a snapshot of their infectious disease and environmental testing capabilities and methodologies. These data were shared with the other consortia members for purposes of emergency preparedness needs and exploring opportunities to share test services. Results: These data, consolidated by APHL, showcase the testing capabilities of these consortia and provide a preliminary glimpse of the planned nationwide PHL test service directory. Further findings will be reported as more data are submitted and analyzed and as the national directory is fully available for use. Conclusion: The PHLSD provides a strategic approach for organizing, reporting, and sharing information, as well as increasing the efficiency of PHL information management. The comprehensive national PHL test directory will allow for greater transparency, enhance opportunities for collaboration, inform interoperability efforts, and be a resource in times of emergency or surge. Presenter: Deborah Kim, MPH, Director, Institutional Research, Association of Public Health Laboratories, 8515 Georgia Ave., Suite 700, Silver Spring, MD 20910, Phone: 240.485.2742, Email: deborah.kim@aphl.org

P-66 Data in Action! Interactive Data Visualizations J. Rosalez, D. Kim and S. Daher, Association of Public Health Laboratories, Silver Spring, MD Objective: Data visualization is an innovative method to display data that allows the user to interact with the dashboard and view information in a more impactful manner. APHL has adopted this venue to showcase the data collected via surveying our members. Project Design: APHL has been working with Deloitte to develop such data visualization dashboards to provide our members with an interactive display of data and information. Dashboard data was pulled from APHL’s longitudinal surveys including the Comprehensive Laboratory Services Survey (CLSS), the All-Hazards Preparedness Survey, and data garnered from the NewSTEPs Data Repository. The dashboards have been presented at numerous meetings to gather feedback and the final version have been made available to members. Results: The dashboards presented received very positive feedback from members. They provide a new venue for APHL to present the data collected via surveys and allow members to interact with data by selecting certain filters to dissect and tailor the information in a way that is most useful. APHL has acquired the software, trained staff and created a subcommittee to assist in the development of new data dashboards. Conclusion: Data visualization dashboards provide members with a useful and interactive resource as well as allows APHL to deliver information in a meaningful way. Presenter: Jacob Rosalez, MA, Senior Specialist, Association of Public Health Laboratories, 8515 Georgia Ave., Suite 700, Silver Spring, MD 20910, Phone: 240.485.3830, Email: jacob.rosalez@aphl.org

P-67 Evaluating the Success of the L-SIP Assessments A. Weber1, L. Kurimski2, S. Marshall3, T. Kunde4, B. Su5; 1LabLogic, East Helena, MT, 2State Hygienic Laboratory at the University of Iowa, Coralville, IA, 3Wisconsin State Laboratory of Hygiene, Madison, WI, 4New Mexico Department of Health, Albuquerque, NM, 5Association of Public Health Laboratories, Silver Spring, MD Objective: Since 2007, the Association of Public Health Laboratories’ (APHL) Laboratory System Improvement Program (L-SIP) has encouraged state and local public health laboratory (PHL) systems to connect their system partners and to discuss future activities for system improvement through conducting an L-SIP assessment. This study was conducted to identify and document the impact of conducting an L-SIP assessment on these systems.

Study Design: In 2010 and 2014, APHL distributed L-SIP impact surveys to L-SIP participants to capture changes and activities that occurred post-L-SIP assessment. Questions focused on a variety of topics, such as the goals of the assessment, the subsequent creation of resources and specific workgroups and the changes seen in the laboratory system. Results: In total, 25 state and local public health laboratory systems responded to the survey. Overall, the respondents reported positive outcomes as a result of conducting an assessment. For example, 100% of the respondents met their intended goal of their assessment, such as creating an awareness of the PHL system among partners as well as identifying areas for improvement within the PHL system. 84% of the respondents convened or plan to convene a subset of participants from the L-SIP assessment to plan future activities or review assessment findings. Conclusion: The survey findings suggest that conducting an L-SIP assessment provides a strong foundation for initiating future quality improvement activities and working with system partners on system issues, such as creating new resources. Future impact surveys are planned as an ongoing evaluation of the L-SIP, and continued APHL support will be sought to encourage all public health laboratories to complete an assessment. Presenter: Bertina Su, MPH, Senior Specialist, Laboratory Systems and Standards, Association of Public Health Laboratories, 8515 Georgia Ave., Suite 700, Silver Spring, MD 20910, Phone: 240.485.2729, Email: bertina.su@aphl.org

P-68 Lean Assessments in Public Health Laboratories K. Breckenridge, Association of Public Health Laboratories, Silver Spring, MD Objective: Building on the success of the 2013 Abbott Laboratories Lean Assessment pilot project, Abbott repeated the offer to provide a Lean consultant to conduct assessments of process flow in three public health laboratories (PHS), with a follow-up session to recommend the potential changes that will improve workflow utilizing Lean concepts. Project Design: Interested laboratories submitted online applications describing projects or processes that they would like to improve on. The reasons why these processes and projects need improved efficiency were outlined. The selection of the assessment sites was conducted by review of applications by APHL and Abbott staff. At the writing of this abstract, review of applications was in process, so the list of sites and their projects that were selected will be updates in time for program printing. Results: The assessment process, findings and recommended next steps will be shared as well what the impacts potential impacts of these changes are. Conclusions: It is expected that if the recommendations from the assessments are followed, a new level of efficiency will be obtained with a savings of time and or budget. Since the selection of sites is currently underway, this section will be updated on the actual poster.

Presenter: Karen Breckenridge, MBA, MT(ASCP), Director, Quality Systems, Association of Public Health Laboratories, 8515 Georgia Ave., Suite 700, Silver Spring, MD 20910, Phone: 240.485.2756, Email: karen.breckenridge@aphl.org

P-69 Impact of APHL Lean Training on Public Health Laboratories K. Breckenridge, S. Daher, C. Johnson, P. Ray, J. Rosalez and D. Kim, Association of Public Health Laboratories, Silver Spring, MD Objective: As public health laboratories continue to be challenged to do more with less, many have looked at using Lean principles to improve processes, eliminate waste, and increase efficiency. To assist member laboratories in gaining practical knowledge about Lean processes the Association of Public Health Laboratories (APHL), provided basic and advanced Lean training. To document the influence of that Lean Training, an impact survey of attendees was conducted. Project Design: A ten question post course evaluation was sent to past participants from the two 2012 basic trainings and the 2013 advanced training. Participants were asked if they had used knowledge obtained from the training to conduct any types of lean assessments in their laboratories, what Lean elements had most aided them, what specific laboratory activities or processes had been improved and if they had trained other staff on any Lean concepts or procedures. Results: In spite of only a 38% response rate, the majority (91%) have made changes in their laboratory with 80% stating that this was based on knowledge gained as a direct result of the training. Examples of the changes made will be outlined with descriptions of the benefits and Lean tools utilized. Conclusions: By participation in the Lean trainings, 91% of respondents were able to conduct some improvement processes in their laboratories, 36% had trained others showing that the investment in training was beneficial to many PHLs. Presenter: Karen Breckenridge, MBA, MT(ASCP), Director, Quality Systems, Association of Public Health Laboratories, 8515 Georgia Ave., Suite 700, Silver Spring, MD 20910, Phone: 240.485.2756, Email: karen.breckenridge@aphl.org

P-70 20 Years of the APHL/EID Laboratory Fellowship Program H. Roney1, L. Vaughan2; 1Association of Public Health Laboratories, Silver Spring, MD, 2Centers for Disease Control and Prevention, Atlanta, GA The Association of Public Health Laboratories/Centers for Disease Control and Prevention Emerging Infectious Diseases (APHL/CDC EID) Laboratory Fellowship Program began in 1996. This past year (2014) the 20th class of EID Laboratory Fellows was selected from 325 applicants, and placed in their host laboratories for one-year assignments. Nearly 500 young scientists have participated in the program over the past 20 years. Enthusiasm for the program (as well as its encouragement of scientists to enter the field of public health laboratory science) has grown among both young scientists and staff at CDC and APHL member public health laboratories. Despite its popularity, budget cuts are threatening the future of this program. At this 20th year milestone of the program, the threat of terminating the program due to budget cuts prompted APHL to undertake a study to evaluate the success of the program. APHL staff contacted past fellows in October 2014 to request information about their experience with the EID Laboratory Fellowship Program and their subsequent careers paths. The data collected included the fellows’ current professional positions, and feedback on the EID program’s impact on their professional careers. This study illustrates what percentage of program participants pursued careers in public health laboratory practice, and/or other public health-related fields. It also highlights important roles fellows filled in their laboratories, and the benefits of hosting fellows to those laboratories. The goal of this study is to demonstrate the value of this fellowship program in identifying and training young scientists for careers in public health laboratory practice, thereby strengthening a competent workforce to face current and future challenges in public health practice. Presenter: Heather Roney, MA, Senior Program Manager, Fellowship Program, Association of Public Health Laboratories, 8515 Georgia Ave., Suite 700, Silver Spring, MD 20910, Phone: 240.485.2778, Email: heather.roney@aphl.org

P-71 Implementing a Laboratory Mentorship Program to Improve Testing Quality and Capacity in Cambodia L.A. Perrone1, V. Voeurng2, S. Sek2, S. Song2, J.F. Flandin1, D. Confer1, R. Martin1; 1International Training and Education Center for Health, Department of Global Health, University of Washington, 1Seattle, WA, 2Phnom Penh, Cambodia Purpose: The development of functional laboratory systems is increasingly recognized as a key component of sustainable health care systems. Yet, in resource-constrained countries many laboratories still provide poor quality testing that is often unreliable, untimely or altogether

incorrect. Suboptimal performance of health laboratories can have detrimental consequences on patient diagnosis, treatment and management as well as impacting the quality of data for adequate disease surveillance and health policy making. The goal of I-TECH’s program in Cambodia is to improve laboratory operations through improved laboratory quality assurance and management practices. I-TECH is developing a cadre of quality improvement (QI) laboratory mentors who will act as resident advisors to laboratory staff across the national and provincial hospital laboratory network. Methods: Working with the WHO, the Cambodian MoH and the US CDC, we are implementing a laboratory quality improvement and clinical mentoring program to strengthen the quality and capacity of infectious disease diagnosis and surveillance in national and provincial laboratories across Cambodia. I-TECH is working in 8 provincial hospital laboratories (Takeo, Kampot, Kampong Cham, Svay Rieng, Kandal, Prey Veng, Sihanoukville, Kratie), the National Veterinary Research Institute, and 4 national hospital laboratories (Preah Kossamak, National Pediatric, Ang Duong, Khmer Soviet Friendship) in Phnom Penh to provide training and onsite mentoring to staff on quality management and quality systems implementation. Laboratory quality is monitored closely on site by local QI mentors and progress is measured using an excel based Laboratory Quality System Implementation (LQSI – Royal Tropical Institute) checklist developed in English and Khmer that tracks QMS implementation progress in 465 activities through 4 phases. Mentors rotate each week among laboratories to assure close follow-up. Results: Since initial QMS training of staff from the first cohort of hospital laboratories (n=6) in August 2014, all laboratories have achieved >85% implementation of the 104 activities in Phase 1. Laboratories in LQSI cohort 1 have improved operations in the areas of facilities and safety, organization, personnel roles and responsibilities, equipment maintenance, purchasing and inventory, process management, documentation and communication. Laboratories in cohort 1 began Phase 2 of LQSI in February 2015 and the second cohort of hospital laboratories (n=6) began Phase 1 of LQSI in April 2015. Conclusions: The presence of full time QI mentors who support laboratories on site and on a regular schedule is a highly effective means of training laboratory staff in new concepts and procedures related to quality management. On site mentoring allows for laboratory staff to remain on the job without disruption to laboratory service provision. Our mentoring methodology has proven highly effective in implementing QMS in our target sites with rapid achievements in a short period of time. Presenter: Lucy A. Perrone, MSPH, PhD, Assistant Professor, Laboratory Systems Development Team, International Training & Education Center for Health (I-TECH), Department of Global Health, University of Washington, Seattle, WA, Phone: 206.221.5559, Email: perronel@uw.edu

P-72 Implementation of a Professional Development Program in Clinical and Public Health Laboratory Leadership and Management in the Middle East and North Africa L.A. Perrone1, E. Scott1, L. Livingston2, C. Bradburn1, A. McGee1, T. Furtwangler3, S. Shotorbani1, D. Confer1, A. Downer1, A. Mokdad4, R. Martin1; 1International Training and Education Center for Health, 4Institute for Health Metrics and Evaluation, Department of Global Health, University of Washington, 2Interactive Outcomes LLC, 3Program for Appropriate Technologies in Health (PATH), Seattle, WA Purpose: A lack of strong and effective leadership of national public health programs is one of the many factors cited for the slow progression toward achieving the health Millennium Development Goals. The WHO and signatories of the 2005 International Health Regulations acknowledge the importance of quality laboratory testing and recognize the need to addressing the development of sustainable laboratories in resource-limited countries in which many of the “hot-spots” for emerging infectious diseases exist. Laboratories need leaders who can utilize the laboratory’s resources effectively, maximize the capacity to detect disease and have the skills necessary to advocate for laboratories in a fluctuating health care environment. The International Training and Education Center for Health (I-TECH) and the University of Washington are committed to training clinical and public health laboratory managers and directors to assume important roles in advocacy, policy development, and inter-agency coordination, and to become more effective leaders in public health. We have developed an in-service program for clinical and public health laboratory directors and managers with the goal of enabling participants to make substantive and impactful improvements in laboratory testing quality and operations. It employs a mentored, blended learning approach utilizing both in-country and online training. Methods: The 9 month professional development program was delivered through two in-person meetings and a series of four distance-learning courses via an online learning management system. The coursework addressed key competencies such as: laboratory testing quality, laboratory systems, leadership and management, analysis and communication of laboratory information, law and regulation of laboratory practice and appropriate implementation of diagnostic technology. Discussion boards supported communication among participants. A required capstone project addressed improving their home laboratory operations and visibility in the health system. Results: This program was implemented in 2014 and included 17 participants and 11 senior mentors from 10 countries across the Middle East and North Africa (Egypt, Morocco, Iraq, Oman, Qatar, Lebanon, Jordan, Pakistan, Saudi Arabia, and Yemen). The 10 day introductory in-person meeting was crucial to build rapport amongst our participants and mentors and provided a strong foundation that supports them as a community throughout the online program. Timely support by faculty and active involvement from the mentors was important for participant satisfaction. Capstone projects addressed critical laboratory capacity issues such as organization and management, documentation and records management, biosafety and biosecurity improvements among others and included comprehensive laboratory assessments. Overall, the

program was highly successful with 80% of participants completing the program and making impactful improvements in their laboratories. As a result of this program participants created a professional association, the “East Mediterranean Society for Laboratory Management” and a website will be created to facilitate networking of laboratory professionals in the region. Conclusions: In-service and online professional development programs such as this program in laboratory leadership and management demonstrate an effective method to improve laboratory operations management of clinical and public health laboratories and are important contributing factors to the success of public health efforts globally. http://edgh.uw.edu/lab-certificate. Presenter: Lucy A. Perrone, MSPH, PhD, Assistant Professor, Laboratory Systems Development Team, International Training & Education Center for Health (I-TECH), Department of Global Health, University of Washington, Seattle, WA, Phone: 206.221.5559, Email: perronel@uw.edu

P-73 Funding Distribution Over a Five-Year Biomonitoring Project B. Rhodes, Washington State Public Health Laboratories The Washington State Public Health Laboratories conducted a five-year biomonitoring project with constant funding each year. The Washington Environmental Biomonitoring Survey (WEBS) began with collection of clinical specimens state-wide in order to establish background levels of each of the biomonitoring analytes. The laboratory adapted and validated new methods then ran the multitude specimens over the duration of the project. After the background collection WEBS then solicited and tested specimens from subpopulations to test the effects of locality, ethnicity, or other commonalities. The poster presents and discusses the relative distribution of funding to the four teams that comprised the WEBS organization: Epidemiology, Laboratory, Toxicology, and Information Technology. The percentage of funding to each team for each year of the project, generates predictable results that may be used by others when planning to fund a biomonitoring project. Presenter: Blaine N. Rhodes, Office Director, Environmental Laboratory Sciences, Washington State Public Health Laboratories, 1610 NE 150th Street, Shoreline, WA 98155, Phone: 206.418.5520, Email: blaine.rhodes@doh.wa.gov

P-74 Whole Genome Analysis of Influenza A/H1PDM09 and A/H3 Viruses Using Next Generation Sequencing J. Laplante, J. McGinnis and K. St. George, Wadsworth Center, New York State Department of Health, Albany, NY The Wadsworth Center, conducts testing and surveillance for influenza. The laboratory has investigated next generation sequencing (NGS) for whole genome sequencing (WGS) of influenza viruses. Goals include monitoring for new reassortants, resistance mutations and changes in virulence, tropism and antigenicity. A published RT-PCR assay, which amplifies all 8 segments of the genome, was modified with QIAamp Viral RNA extraction, qScript™ XLT one-step RT-PCR and Uni/Inf primers. Product was analyzed on a MiSeq instrument, raw reads assembled using SPAdes and assembled reads analyzed with Sequencher® and Geneious. Consensus sequences were aligned and analyzed with several purchased and free-ware programs. Alignments were analyzed against vaccine strain and NYS sequences from GISAID across 2010-15 seasons using phylogenetic analysis with MEGA6. Viral RNA from primary specimens and cultured isolates collected in NYS during the 2013-14 and 2014-15 influenza seasons were tested. WGS was analyzed for six A/H1pdm and ten A/H3 samples. The LOD was approximately 500 gc/reaction. Mutations were detected in all 8 segments of both subtypes compared to the 2014-15 vaccine strains. Highest mutation rates were in the HA and NA segments including resistance mutations in both A/H1pdm and A/H3 viruses and the addition of a glycosylation site in 2014 A/H3 viruses. Trees from HA and NA sequence data demonstrated clustering of A/H1pdm from 2011-14 separate from those in 2010, and of A/H3 viruses from 2014 separate from previous 4 seasons. An RT-PCR has been modified for routine NGS and WGS of influenza, with sufficient sensitivity for use directly on primary clinical specimens. Application of the new method to influenza samples is ongoing, with interrogation against US and global sequences. Additional studies include WGS comparisons across specimens and paired isolates, as well as the investigation of predicted protein structure to better understand mutations effects. Presenter: Jennifer Laplante, Laboratory of Viral Diseases, Wadsworth DAI, New York State Department of Health, 120 New Scotland Ave, Albany NY, Phone: 518.474.4177, Email: jennifer.laplante@health.ny.gov

P-75 Re-design of a Virology Laboratory’s Outdated Ordering and Inventory Process Using LEAN Tools M. Fuschino1, A. Dean1, C. Flood2, D. Rusinko1, J. Laplante1, J.A. Dopp2, R. Ramani1, S. Brunt1, T. Church1, K. St. George1; 1Laboratory of Viral Diseases and 2Division of Infectious Diseases, Wadsworth Center, NY State Department of Health, Albany, NY Ancillary processes such as inventory and supply replenishment can become confusing, complex and inefficient. The Laboratory of Viral Diseases at Wadsworth applied LEAN tools to re-work the process for tracking and re-ordering supplies. The old system employed an electronic inventory database that was incomplete, inaccurate and time-consuming to maintain. Key lab personnel and administrative staff worked with a LEAN consultant, in a biphasic Kaizan approach focused on identifying wastes and strategic process re-design, followed by training and implementation. Value stream mapping sessions identified action items that were addressed at sub-committee meetings. Tasks were delegated and a tactical roll-out plan assembled. 15 process steps were identified during value stream mapping and highlighted 6 non-value added steps. A 9-step process was designed around a Kanban card system, designated stock areas were clearly delineated and orders were tracked through the virtual process. The electronic inventory database was stripped to capture only the information needed to satisfy regulatory requirements. Receiving and QC paperwork were combined to save time and better facilitate tracking of lot numbers and expiration dates. Process maps for removing, re-ordering and replacing stock were displayed to help ensure standardized practices and a weekly check-back was instituted. Time spent on preparing orders was reduced from 5-10 hours to 30 minutes and times for placing orders improved from approximately 1 week to 2 days. Supplies are now received within 1-2 weeks from time of identified need, compared to 4-6 weeks. Improved communication, visibility, accountability and standardization were key factors to successfully eliminating waste, improving flow and implementing a sustainable, robust new system. LEAN tools applied to ancillary processes can directly impact laboratory testing by freeing staff time, reducing stress and helping ensure the availability of supplies. Presenter: Meghan Fuschino, Laboratory of Viral Diseases, Wadsworth DAI, New York State Department of Health, 120 New Scotland Ave, Albany NY, Phone: 518.474.4177, Email: meghan.fuschino@health.ny.gov