Lab Matters Summer 2017 | Page 41

member spotlight Hospital of Pittsburgh, where I became director of the hospital’s microbiology lab.” He stayed at Children’s Hospital for 30 years, working for much of that time with his third mentor, Richard Michaels, MD. Toward the end of his tenure at the hospital, after being “pigeon-holed” in a pediatric molecular diagnostic laboratory, Wadowsky was ready for a new challenge: “I wanted to see if I could do something on a larger scale.” Fortunately, Allegheny County was just then opening its new PHL facility and needed a director. Wadowsky got the job. Within the past few years, PHL scientists have confirmed the source of at least three such outbreaks: Staff In addition to testing clinical and environmental samples, the main laboratory provides analytical support to the medical examiner’s office in the City of Pittsburgh. “The biggest concern for autopsy cases,” said Wadowsky, “is meningitis, which has potential for spread in the community.” Over the past three years, scientists confirmed about three cases of Neisseria meningitidis in deceased young adults. Another recent autopsy case identified Streptococcus viridans as the cause of death in a five-year-old child, who apparently contracted strep infection through a mouth wound. • Yersinia enterocolitica contaminated milk products sold by a local dairy. • E. coli O157 tainted ground beef traced to a restaurant where staff were undercooking the beef. This outbreak involved at least a dozen confirmed cases, including a number of college students. • Bacillus cereus tainted food served at the county jail. The laboratory employs 21 staff members, including eight microbiologists, four supervisors, five laboratory technicians, two clerks, an assistant laboratory manager and director. There is currently one vacancy for a microbiologist in the laboratory’s BSL-3 virology program. Revenue The laboratory’s annual budget runs to about $1.3 million, plus an additional $700,000/year for drug screening to support the criminal and family courts in Pittsburgh and McKeesport. Most of this revenue comes from the county, with supplemental funding from the Pennsylvania Department of Health for emergency preparedness and HIV and STD testing. The laboratory collects no fees for any of its services. Testing Altogether, the PHL performs about 90,000 tests per year, ranging from high-volume STD testing to specialized analyses. The stand-alone STD laboratory performs direct microscopy testing (gram stains for gonorrhea, wet mounts for Trichomonas and KOH preparations for yeasts) on samples from county clinic patients, while the main laboratory conducts a range of tests on samples from the same population to detect HIV (serology), syphilis (serology), Hepatitis A, B and C (serology), Neisseria gonorrhea (culture, nucleic acid amplification testing), Chlamydia (culture, NAAT), Herpes simplex virus (culture) and Trichomonas (culture). The laboratory’s food testing program supports county epidemiologists and food safety officials investigating possible foodborne disease outbreaks. PublicHealthLabs @APHL Success Stories • Not long ago, all of the laboratories’ STD reports were generated on hand-written forms with multi-part copies—“the types of reports I used at Mercy Hospital 35 years ago.” Not so anymore. The laboratory recently implemented a LIMS in its STD clinic, doing much of the design work in-house. Today, STD specimens are accompanied by a computer-generated “work card” with peel-off bar codes that can be applied to “tubes and plates and slides.” Wadowsky credits the electronic system with “a lot of time-savings and improved accuracy.” • Implementing the BioFire FilmArray ® gastroi ntestinal panel last year. The new assay detects 22 pathogens via PCR and delivers results within an hour. Since implementing the system in November 2016, the laboratory has already confirmed six norovirus outbreaks. • Replacing the Western blot assay with the Bio-Rad GeeniusTM HIV-1/ HIV-2 Supplemental Assay. • Designing the new STD lab. APHL.org • Initiating two quality improvement projects as part of the health department’s culture of quality. One project focuses on streamlining the process through which clients order swab and urine specimen collection devices for gonorrhea and chlamydia nucleic acid amplification testing; the other focuses on reducing the incidence of false-positive urine screens for benzodiazepines. • Developing a surge capacity staffing list/protocol and specimen handling and submission protocols, also to enhance the culture of quality. Challenges • Maintaining the facility: “We have no physical plant manager, so when something goes awry, the director has to figure out what’s wrong and get someone to come and fix it.” With the building’s sophisticated BSL-3 laboratory and HVAC and security systems, this is a big challenge. • Maintaining accreditations under CLIA, the Commonwealth of Pennsylvania, the Environmental Protection Agency and the CDC Select Agent Program. • “Making do” with no dedicated staff for select agent BSL-3 testing. • Lack of discretionary funds to repair or replace inoperable equipment or deal with other emergencies. • Keeping up with the scientific literature in PHL diagnostics, given “so many other demands on our time.” Goals • To fully implement the BioPlex ® 2200 multiplex platform to test for fifth- generation HIV, syphilis, measles, mumps, rubella and varicella. The platform was installed in late May and verification studies are ongoing. • To develop a LIMS interface with the BioPlex ® , plus customized LIMS data entry screens and automated reports for HIV and syphilis test results. • To become a reference-level member of the Laboratory Response Network for Biological Testing (LRN-B) by the end of 2018. • To implement point-of-care lead testing for capillary blood specimens. n Summer 2017 LAB MATTERS 39