Lab Matters Fall 2017 | Page 37

member spotlight Candice Le performs RPR syphilis serology testing. Photo: PHSKC Staff In addition to Swenson, the laboratory employs 11 people: Laboratory Manager Alfred Iqbal, PhD, six microbiologists, one laboratory assistant, two administrative staffers, and a part time medical technologist who oversees CLIA- waived, point-of-care testing at county clinics. Although the laboratory has no current vacancies—“we seldom do”—Swenson anticipates one staff retirement within the next year. The laboratory’s annual $2.4 million budget comes mainly from fees for services provided to PHSKC clinics. Those fees are billed through a unique system, started in 2012. As Swenson explains, “We basically have no [dedicated] funding. There is an internal system through which we bill all of our public health clinics for the testing that we do, and we are expected to bring in sufficient revenue from those clinics to meet all of our expenses.” Theoretically, said Swenson, “As our expenses increase over time, we can increase what we charge our clinics to cover those costs.” Yet, in practice, he said, “We’re under tremendous pressure to be cost-competitive and to keep our fees as low as they can possibly be, because the clinics are also under tremendous budget constraints, and our fees are a big cost to them. ... So raising fees is not an option if there’s any way it can be avoided.” In addition to internal clinic payments, some CDC-funded work, clinical testing for external providers and occasional clinical studies for local biotech companies “bring in a few dollars.” Testing The vast majority of the 90,000 or so tests performed by the laboratory each year are routine diagnostic analyses: serology @APHL • Finalizing a memorandum-of- understanding (MOU) with the Washington State Public Health Laboratory to assure “the most efficient, cost-effective laboratory services for the state of Washington.” Although some of the details are still being hammered out, the MOU allows the laboratory to free up surge capacity at the state level by taking on routine clinical testing during public health emergencies requiring state laboratory support. In addition, the laboratory performs: Challenge • TB cultures, smears and QuantiFERON ® –TB Gold assay for the county TB clinic at HMC. “Just maintaining adequate resources to support the cost of the services we provide is our biggest challenge. The clinics [that provide the bulk of the laboratory’s funding] are under such budget constraints that they’ve had to get smaller, and that can trickle down to the laboratory.” In fact, three county family planning clinics closed in 2015, representing the first clinic closures in three decades. The county’s next biennial budget cycle begins in 2019, and, said Swenson, “There’s a fair amount of uncertainty about what’s going to happen.” • Surveillance and outbreak testing for influenza and other respiratory viruses. Revenue PublicHealthLabs tests for HIV, syphilis and hepatitis and nucleic acid amplification tests (NAATs) for chlamydia and gonorrhea. Virtually all of this work is conducted on behalf of 11 PHSKC clinics, including STD and TB clinics co-located at HMC, three primary care clinics, three family planning clinics, a refugee screening clinic and two jail health clinics. Almost half of all the laboratory’s work comes from the STD clinic alone, which is within easy walking distance. A county- operated courier service transports specimens from outlying clinics. • Miscellaneous, low-volume serology and microbiology tests, such as measles, mumps and rubella antibody testing, gonorrhea cultures and stool cultures. Said Swenson, “There’s a lot of testing that we don’t do, like clinical chemistries or hematologies. We contract with a commercial laboratory to do that work.” Success Stories • Interfacing the ApolloLIMS ® laboratory information management system (LIMS) with the Epic electronic health record system used in PHSKC clinics. As of late August, every clinic but one is linked to the LIMS, and the final clinic is slated to go live by the end of 2017. Prior to this major undertaking, said Swenson, “We were still connected electronically [to the clinics], and they could print their lab reports, but they were getting a paper report and would still have to do data entry [into the electronic health record]. Now, no one has to do that.” • Replacing culture- or antigen-based tests with faster, more sensitive NAATs over the past year. Recently implemented NAATs include assays for trichomonas, Group A streptococcus, pertussis, herpes, varicella zoster virus and influenza. “The technology is a good fit for our laboratory.” APHL.org Goals • Evaluate the performance of the QuantiFERON ® –TB Gold Plus test, just recently approved by the US Food and Drug Administration. “Our TB clinic is eager to switch over to that when it becomes available.” • Examine the feasibility of running NAATs for Mycoplasma genitalium, bacterial vaginosis, vaginal candidiasis and other targeted infections on the laboratory’s Hologic ® Panther testing platform. • Evaluate possible use of the reverse screening algorithm for syphilis, which involves screening with one of the new, highly automated treponemal tests and confirming with a rapid plasma reagin test. • Maintain CLIA compliance in our laboratory and in our public health clinics, performing waived testing. n Fall 2017 LAB MATTERS 35