A-299 Beyond Cost Cutting: Balancing Stewardship and Innovation in Modern Laboratories

Abstract

In 2024, the Cincinnati Children’s Hospital Medical Center (CCHMC) Clinical Laboratories established the Laboratory Value Analysis Committee (LVAC) to develop evidence based, clinically sound, and financially responsible plans that support safe, effective, and value-added clinical laboratory testing while still maintaining our commitment to innovative testing to advance pediatric healthcare. This was accomplished by creating a process for evaluating new and replacement tests, equipment, and instrumentation to ensure the right test is provided at the right time and location for each patient. Herein, we describe our process for establishing this type of multi-disciplinary committee and current outcomes. A clinical lab steering planning team was established in partnership with our hospital value analysis team in 2023 to design the LVAC, establish its charter, membership, workflows, meetings, and documents. Socialization and education of the committee was completed by end of 2023 with the committee beginning in January 2024. We created a request form to help capture innovation value and developed an innovation index scale to help identify uniqueness of an assay (first offering in US, for a unique diagnosis, regionally/nationally marketable, or supporting a research program), test complexity (lab developed test, automation capability, interpretation/consultation needed by content area expert), equipment details, and financial analysis. We also created an intake form to facilitate review by the LVAC committee to evaluate the value added to our laboratory and the potential impact to the broader scope of pediatric laboratory medicine. Topics for value added included patient care (improved turn-around-time, increased patient safety, lower sample collection volume, support of a clinical program including development of diagnostic test algorithms); efficiency (improved specimen processing, automation/interfacing); innovation (novel test, support of a research program) and cost (decreased cost to patient, decreased cost to perform). Since the initiation of the LVAC in January 2024, there has been a total of 70 submissions, 5 from clinicians and the remaining from laboratory staff and faculty. Of these, 55 requests have been completed (45 (82%) approved, 4 (7%) not approved, and 6 (11%) cancelled). Of the approved requests, 21(47%) were for new tests (7 (33%) to insource the test), 6 of the 21(29%) new tests were for novel assays with the highest innovation index scores defined with an innovation index of a 4 or 5, 16 (36%) for new or replacement instrument/equipment, 4 (9%) test discontinuations, 3 (7%) internal test relocations, and 1 (2%) method change. Relocation of test methods resulted in decreased average turn-around times, eg. 25-OH Vitamin D from 37 hours to 3.8 hours, Haptoglobin from 13 hours to 1.6 hours, and PTH from 48 hours to 4.5 hours. Balancing laboratory stewardship and diagnostic test innovation presents a unique challenge in laboratory medicine. We described a process for navigating these challenges by defining criteria that captures the value of tests or testing strategies beyond cost savings to remain leaders in novel test development while responsibly meeting laboratory stewardship goals.