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Benge - Laboratory Process Improvement - Riverton, UT, USA

Kirk Benge

Riverton, UT, USA

Services

Laboratory Process Improvement

Summary:

Laboratory Information Management System Integration. Process improvement. Business Analysis. Instrument to LIS interfaces & automation for Microbiology, Virology, Immunology, & Molecular testing.

Work History

Role: Business Analyst

Utah Public Health Laboratory

From October 2013

•Identify, evaluate, and develop business practices within the laboratory as they pertain to and are
impacted by information technology enhancements and modifications.
•Select testing methods to evaluate the success of both software upgrades and modifications.
•Audit and review systems and practices to ensure compliance with procedures, regulations and
standards within the laboratory.
•Evaluate and recommend user level computer system enhancements to better meet customer needs.
•Monitor and evaluate operations, programs, processes and/or practices for quality and effectiveness.

Manager: Virology & Immunology Laboratories

Utah Public Health Laboratory

From May 2011

• Oversee testing for a broad range of viral infections and diseases, including HIV, Syphilis, Chlamydia trachomatis, Gonorrhea, Herpes, Tuberculosis, Hepatitis B & C, and viral respiratory infections.
• Laboratory Information System (LIS) configuration and development (Labware LIMS)
including LIS instrument interface development/maintenance and LOINC/SNOMED coding.
• Supervise WHO/APHL contractual work as a component of the WHO Global Influenza Surveillance and Response System (GISRS)
• Interview, select, train, schedule, motivate, evaluate and supervise laboratory personnel.
• Establish and monitor quality assurance and quality improvement procedures and systems.
• Establish laboratory budgets and maintain laboratory contracts.
• Develop, review, approve and implement laboratory procedures.
• Confer with and report to regulatory agencies.
• Maintain laboratory federal CLIA certification.

Microbiologist III

State of Utah

February 2005 - May 2011

Subject Matter Expert: Labware LIMS development and implementation project .

This project phase was an integration phase during which time laboratory instruments were integrated, analysis components were streamlined and updated, and reporting systems were evaluated and upgraded, including HL7 messaging development and implementation .

Senior Microbiologist

Lead or functionally supervise staff; delegate work assignments, monitor/review quality of work, schedule staff, provide technical assistance or training, and/or provide input on performance appraisal, hiring and discipline.
Assist supervisor in the development and validation of new tests. Evaluate, modify, and/or maintain QA/QC procedures and Standard Operating Procedures.

Perform ELISA and EIA procedures for HIV (including Western Blot), Syphilis (IgG, RPR, FTA), HCVAb, HBsAg, HbsAb, Hantavirus, and SARS.
Mammalian cell line CPE observation and/or DFA/FA staining/microscopy for the detection of Respiratory viruses, Herpes Simplex, and VZV.
NAAT Chlamydia and Gonorrhea testing.
Rabies necroscopy and FA microscopy.

Laboratory Technician II

State of Utah

May 2004 - February 2005

Perform ELISA and EIA procedures for HIV (including Western Blot), Syphilis (IgG, RPR, FTA), HCVAb, HBsAg, HbsAb, Hantavirus, and SARS.
Mammalian cell line CPE observation and/or DFA/FA staining/microscopy for the detection of Respiratory viruses, Herpes Simplex, and VZV.
NAAT Chlamydia and Gonorrhea testing.
Rabies necroscopy and FA microscopy.

Projects

Labware LIMS Development & Implementation

Evaluation and integration phase of a Labware LIMS, (Oracle 10g based laboratory information system) development and implementation project . The system includes the State of Utah’s Microbiology, Toxicology departments, and is a mission critical application that is used by laboratory personnel as well as management to view the status of samples, tests and reports in the lab.
This project phase was an evaluation and integration phase during which time laboratory instruments were integrated, analysis components were streamlined and updated, and reporting systems were evaluated and upgraded, including HL7 messaging development and implementation.

Comparison of Viral Culture to PCR for the Detection of HSV-1/2 & VZV in a Public Health Laboratory

Swabs from suspect HSV-1 and HSV-2 lesions were cultured in Vero and/or MRC-5 cells (inoculated with 200-300ul of transport media and observed for cytopathic effect (CPE) for 7 days). Slides were prepared from cultures exhibiting CPE and cells stained with LIGHT DIAGNOSTICS™ Simulfluor® HSV1/2 Reagent (EMD Millipore, Billerica, MA). Slides were viewed with a fluorescent microscope to confirm presence of HSV-1 or HSV-2. The results were then compared to the findings of the Realstar® alpha Herpesvirus PCR Kit which is “an in vitro diagnostic test for the simultaneous detection and differentiation of HSV-1, HSV-2, and varicella zoster virus (VZV) specific DNA” (Altona Diagnostics). Confirmatory testing was performed on discrepant samples by an outside laboratory using an alternative Luminex® HSV Typing assay on the LightCycler® platform.
Results: Altona Diagnostics RealStar® alpha Herpesvirus PCR Kit indicates increased sensitivity compared to viral culture, along with the added ability to detect VZV in addition to HSV.
Conclusion: Molecular methods for detection of HSV-1 and HSV-2 are a valuable alternative

Project for the Standardization of Laboratory Assay to Monitor Influenza Virus Susceptibility...

Conduct NI testing on national influenza surveillance specimens collected during the 2011-2012 influenza season (in conjunction with CDC and APHL), to standardize influenza neuraminidase inhibition (NI) testing.

In order to standardize IC50data, CDC provided a package of tools, including a detailed protocol, worksheets, reference materials and analysis software, and conducted hands-on training both at CDC and onsite at each of the three contract public health laboratories. These labs implemented the NI assay successfully,
and began conducting NI testing for national influenza surveillance. The standardized IC50data is now used to update weekly reports posted on the CDC website, FluView; thus enhancing the national surveillance for antiviral resistance.
To date, these efforts have been successful, and to our knowledge, this project marks the first time that IC50data have been standardized across multiple laboratories performing influenza antiviral susceptibility testing.

Evaluation of HIV Point of Care Testing Results Compared to Lab-Based Third and Fourth Generation...

Between July, 2010 and May, 2012, Unified State Laboratories: Public Health received 3,860 serum/blood specimens for HIV testing. Of the specimens received, 31 samples flagged as POC reactive by the submitting agencies were evaluated on the Biorad HIV 1-2-O 3rd generation assay and subjected to Western Blot testing on the Biorad HIV-1 Western Blot assay according to standard testing algorithms. Sample aliquots were stored at -20 and retrospectively evaluated on two separate 4th generation screening assays including BioRad 4th generation HIV Ag/Ab and Abbott Architect HIV Ag/Ab combo as well as the BioRad Multispot platform (part of new CDC recommended 4th generation testing algorithm for public health laboratories).

Results:
Of the 31 samples flagged as POC reactive, 29 confirmed positive. Of the two specimens determined to be negative, one sample had reactive result interpretations on all three screening assays (BioRad 3rd gen., BioRad and 4th gen., and Abbott 4th gen.), but was negative on both confirmatory assays (BioRad Western Blot, BioRad Multispot). The other POC reactive sample was interpreted as negative for all three screening assays and both confirmatory assays.

Conclusion:
Among the many benefits associated with rapid testing, HIV POC tests are an accurate and effective means for obtaining HIV results, according to this study’s data. However, with the advent of better sensitivity and specificity and earlier detection times currently available in laboratory settings, the use of POC screening may not always be the most appropriate screening choice, especially in areas of low prevalence and/or situations involving recent exposures. Because of more sensitive technology and faster result output (Abbott Architect HIV 4th Generation test and Biorad Multispot Confirmatory test), laboratory turnaround times have greatly improved, thereby reforming the standard for high-quality testing and services to patients and clinicians.

Evaluation of Abbott Plex-ID for the Detection of Respiratory Viruses vs. Traditional Culture...

The objective of this retrospective study was to evaluate test sensitivity and performance of the PLEX–ID RVP assay in comparison with viral culture methodologies currently used at the Unified State Laboratories: Public Health (USLPH) for the evaluation of postmortem clinical specimens. In this study, 49 respiratory specimens submitted by the Office of the Medical Examiner for viral culture between January and September of 2011 were analyzed by the PLEX-ID RVP assay. The PLEX-ID platform detected respiratory viruses in six culture-negative patient samples as well as additional (multiple) viruses in three samples where traditional culture resulted in positive identification of a single virus. Conversely, viruses not included in the PLEX-ID RVP assay, Herpes Simplex and cytomegalovirus, were detected by culture in two samples.

Evaluation of Abbott PLEX-ID for the Detection of Respiratory Viruses vs. Traditional Culture...

In this retrospective study, 56 respiratory specimens submitted for viral culture between January and September of 2011 were analyzed by the PLEX-ID RVP assay. The PLEX-ID platform detected respiratory viruses in six culture-negative patient samples as well as additional (multiple) viruses in three samples where traditional culture resulted in positive identification of a single virus. Conversely, in one patient sample, respiratory syncytial virus was detected in the original patient specimen by direct fluorescent antibody (DFA), but was not detected by PLEX-ID. We found that the PLEX-ID offers significant reductions in turn-around time and is less labor-intensive than traditional culture.

Assessment of Drug Susceptibility Using a Standardized Neuraminidase Inhibition Assay and the WHO...

Objectives: To utilize the CDC standardized NI assay and apply the WHO-AVWG criteria to
interpret and report NI assay data, in an effort to harmonize and build capacity for national and global
surveillance for influenza antiviral susceptibility.

Methods: Original clinical specimens and/or virus isolates collected by U.S. PHLs since Oct 01, 2012,
were submitted to the NSRC-Is (CA, UT or WI) contracted to perform NI assay testing. First, viruses
were isolated and propagated in MDCK cells to achieve desirable titers. Next, the Fluorescent NI assay
(using the NA-FluorTM kit) was performed according to the CDC standardized protocol, incorporating
the current influenza A and B reference viruses provided by the CDC. Each virus isolate was tested
for susceptibility to two NA inhibitors, oseltamivir (carboxylate) and zanamivir. Reports containing
IC50 values and fold differences for viruses tested each week were sent to the CDC, where results were
evaluated using the WHO-AVWG criteria to assess antiviral susceptibility. Viruses with reduced or
highly reduced inhibition by either drug were genetically analyzed at the CDC, by pyrosequencing and/
or conventional sequencing to detect changes in the NA associated with reduced drug susceptibility.
Genetic analysis was performed on both the clinical specimen (if available) and the matching virus
isolate to confirm the presence of true molecular markers of resistance, as well as changes
resulting from virus propagation in cell-culture.

Labware LIMS Enhancement, Expansion, and Migration

Develop an enhanced laboratory information management system (Labware LIMS) to accommodate evolving agency needs and expand capabilities of the system to include organic chemistry, metals testing, and inorganic chemistry testing while enhancing and updating serology, virology, bacteriology, mycobacteriology, molecular, and bioterrorism functionality.
Design or enhance agency instrument systems to interface as needed.
Evaluate the impact that enhancements and modifications will have on existing standards and systems, and alter or adapt business processes or system processes as necessary.
Migrate all laboratories from legacy LIS systems onto the new Labware platform.

Qualifications & Certifications

Master of Public Health

University of Utah

Microbiology

Weber State University

Associate of Science

Snow College

North Sanpete High School

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