Tennessee hospital noncompliance with price transparency legislation for 8 common laboratory tests.

OBJECTIVES: The goal of this study was to assess hospital compliance with federal price transparency mandates and barriers to pricing information in Tennessee. METHODS: All hospitals websites were queried for gross, cash, and BlueCross BlueShield of Tennessee prices for 8 high-frequency laboratory tests in 2 Centers for Medicare & Medicaid Services-mandated pricing sources: (1) a machine-readable file of all available services and (2) a consumer-friendly display of 300 shoppable services. Barriers, including click counts, data availability, and intrahospital price discrepancies, were noted. RESULTS: Of the 145 Tennessee hospitals assessed, 97.2% were noncompliant with the Centers for Medicare & Medicaid Services final rule. Subanalysis of available machine-readable files, price estimators, and shoppable services files demonstrated 49.6%, 95.1%, and 78.6% noncompliance, respectively. Barriers to pricing information included requiring protected health information (55.9%), missing at least 1 pricing source (7.6%), having no pricing sources available (6.2%), and involving more than 3 clicks to access the cash price in machine-readable files (54.1%) and price estimators (68.6%.) Average intrahospital discrepancy for basic metabolic panel cash prices across pricing sources was $101.30 (range, $0-1012.40). CONCLUSIONS: Our study showed high levels of noncompliance with price transparency laws, inconsistent and inaccessible pricing, and continued challenges facing patients in Tennessee.

Spironolactone metabolite causes falsely increased progesterone in the Abbott Architect immunoassay.

BACKGROUND: Immunoassays are important for routine clinical testing and medical diagnosis. However, they are limited by cross-reactivity especially at low analyte concentrations. There is a critical need to investigate compounds that can interfere with immunoassays. Herein, we describe the identification of canrenone, a spironolactone metabolite that falsely increases progesterone concentrations on the Abbott Architect i2000 Immunoassay. METHODS: Serum samples and assay diluents were spiked with spironolactone or canrenone and progesterone concentrations were measured on the Architect i2000 and Immulite XPi immunoassay platforms. Blood samples from patients taking spironolactone were analyzed with liquid chromatography-tandem mass spectrometry to evaluate the intrinsic response of progesterone concentrations to the presence of canrenone. RESULTS: We measured approximately 10-fold higher progesterone concentrations on the Abbott Architect i2000 compared to reference immunoassay analyzers (Siemens Immulite XPi and Roche Cobas e601/602), suggesting an analytical error which is unique to the Architect i2000 antibody and/or assay conditions. By measuring serum progesterone after addition of spironolactone or canrenone to serum samples, we found that canrenone falsely increased progesterone on the Architect i2000 immunoassay. However, this interference was more pronounced at low serum progesterone concentrations. Moreover, a strong positive correlation was seen between canrenone and measured serum progesterone concentrations. CONCLUSIONS: Our investigations are important for individuals who require progesterone measurements using the Architect i2000 immunoassay, especially because it is unlikely for clinicians to order canrenone measurements alongside progesterone measurements for individuals taking spironolactone. Further research is needed to determine whether canrenone can influence progesterone measurements on other immunoassay systems.

College of American Pathologists Quality Cross Check -Chemistry and Therapeutic Drug Monitoring as a tool for biannual instrument correlations.

BACKGROUND: Biannual instrument-correlation studies are required for nonwaived assays performed on multiple instruments. OBJECTIVE: To determine the feasibility of using College of American Pathologists (CAP) Quality Cross Check-Chemistry and Therapeutic Drug Monitoring (CZQ) to assess instrument correlations among multiple analyzers, analyzer models, and Clinical Laboratory Improvement Amendments (CLIA) licenses for 55 unique analytes. METHODS: Instrument correlation studies were performed on 9 Abbott ARCHITECT instruments (c4000 [n = 4], c8000 [n = 2], and c16000 [n = 3]) over 3 CLIA licenses using CZQ materials. The mean (SD) values, concentration difference, percent bias, and peer data for each individual level of CZQ were determined for each individual analyzer. Acceptable concentration and percentage for each analyte were set using criteria from CAP or other reputable sources such as the American Association of Bioanalysts or the Royal College of Pathologists of Australasia. Peer data were provided by CAP with the CZQ kit. RESULTS: Correlations using CZQ materials showed that 94.5% of assays studied were within the acceptability criteria by percent bias only and 98.2% were within acceptability criteria by concentration difference. CONCLUSIONS: The use of CZQ provides support to standardized correlation studies among instruments within and across separate CLIA licenses. However, widespread adoption of CZQ may be limited due to concerns regarding matrix effects, analyte ranges, and ease of data analysis.

Cannabis positivity rates in 17 emergency departments across the United States with varying degrees of marijuana legalization.

BACKGROUND: Many states in the United States have progressed towards legalization of marijuana including decriminalization, medicinal and/or recreational use. We studied the impact of legalization on cannabis-related emergency department visits in states with varying degrees of legalization. METHODS: Seventeen healthcare institutions in fifteen states (California, Colorado, Connecticut, Florida, Iowa, Kentucky, Maryland, Massachusetts, Missouri, New Hampshire, Oregon, South Carolina, Tennessee, Texas, Washington) participated. Cannabinoid immunoassay results and cannabis-related International Classification of Diseases (ninth and tenth versions) codes were obtained for emergency department visits over a 3- to 8-year period during various stages of legalization: no state laws, decriminalized, medical approval before dispensaries, medical dispensaries available, recreational approval before dispensaries and recreational dispensaries available. Trends and monthly rates of cannabinoid immunoassay and cannabis-related International Classification of Diseases code positivity were determined during these legalization periods. RESULTS: For most states, there was a significant increase in both cannabinoid immunoassay and International Classification of Diseases code positivity as legalization progressed; however, positivity rates differed. The availability of dispensaries may impact positivity in states with medical and/or recreational approval. In most states with no laws, there was a significant but smaller increase in cannabinoid immunoassay positivity rates. CONCLUSIONS: States may experience an increase in cannabis-related emergency department visits with progression toward marijuana legalization. The differences between states, including those in which no impact was seen, are likely multifactorial and include cultural norms, attitudes of local law enforcement, differing patient populations, legalization in surrounding states, availability of dispensaries, various ordering protocols in the emergency department, and the prevalence of non-regulated cannabis products.

Opportunities for recycling in an automated clinical chemistry laboratory produced by the comprehensive metabolic panel.

OBJECTIVES: Clinical laboratories perform a variety of tests for which biomedical waste is a byproduct. Of these, the complete metabolic panel (CMP) produces a significant portion of this waste. We investigated specific waste subsequent to performing CMPs over the course of a year and analyzed what percentage of the waste produced could have been recycled. METHODS: Patient testing volumes were collected retrospectively from July 14, 2021, to July 14, 2022, for individual assays within the CMP performed on Abbott Alinity c instruments (n = 6). The average weights for components of the reagent kits, which includes wedges, boxes, and package inserts, were calculated. These weights, in conjunction with total patient testing volumes, were used to determine the amount of waste produced. RESULTS: A total of 1089.2 kg of reagent kit waste was estimated to be produced by performing CMPs throughout a year. Of this waste, most (855.5 kg) was not recyclable, but a subset (233.6 kg) was. Overall, 21.4% of the total specific waste weight was found to be recyclable. CONCLUSIONS: The CMP contributes a substantial amount of waste when performed on chemistry analyzer platforms in the clinical laboratory. Paper inserts and cardboard packaging, however, presented opportunities for recycling.

The impact of environmental factors on external and internal specimen transport.

The environment that a clinical specimen is exposed to is an important preanalytical factor in laboratory testing. There are numerous environmental conditions that a specimen may experience before it arrives at the clinical laboratory for analysis. Specimens collected at offsite locations are typically stored at the site and transported to the clinical laboratory via courier. Depending on the geographic location, season, method of storage and method of transport, the specimen can experience varying climate conditions that can lead to inaccurate test results. Specimens collected within the healthcare institution are not exempt from suboptimal storage and transport environments. For example, specimens transported via pneumatic tube systems can experience extreme agitation and rapid accelerations and decelerations. Suboptimal storage and transport temperatures occur less frequently within health systems due to multiple regulatory requirements for temperature monitoring; however, temperature monitoring may not occur at every stage of the preanalytical phase. This review will highlight both internal and external environmental conditions that can cause preanalytical errors in clinical laboratory testing. Strategies to mitigate environmentally-induced preanalytical errors and regulatory gaps for environmental monitoring in the preanalytical phase will also be discussed.

Temperature Optimization Within 2 Uniquely Designed Courier Lockboxes During Extreme Summer Temperatures.

OBJECTIVES: To determine optimal temperature profiles for 2 uniquely designed courier lockboxes (steel vs polymer) by standardizing daily ice (-20ºC) and cold (4-8ºC) pack placement. METHODS: Paired courier lockboxes were placed outside in direct sunlight. Ambient outdoor and lockbox temperatures were monitored during 2 4-day cycles, and temperature mean and range were determined daily (time frame, 4:00-10:00 pm). Control lockboxes without packs were compared with experimental paired lockboxes with either 2 cold packs placed at 4:00 pm or 4 ice packs placed at 8:00 am and replaced with 4 cold packs at 4:00 pm daily. RESULTS: Cycle 1 mean temperatures within control steel and polymer lockboxes were 31.8ºC (range, 18.4-44.1ºC) and 37.2ºC (range, 27.1-46.7ºC), respectively. The addition of 2 cold packs at 4:00 pm reduced mean temperatures to 29.1ºC (range, 19.1-37.2ºC) and 25.3ºC (range, 20.0-31.6ºC) in steel and polymer boxes, respectively. Cycle 2 mean temperatures within control steel and polymer lockboxes were 28.3ºC (range, 22.4-40.8ºC) and 31.6ºC (range, 23.8-41.0ºC), respectively. The addition of 4 ice packs at 8:00 am and replacement with 4 cold packs at 4:00 pm reduced mean temperatures to 24.3ºC (range, 17.4-27.9ºC) and 13.4ºC (range, 6.6-18.1ºC) in steel and polymer boxes, respectively. CONCLUSIONS: Standardizing instructions for ice and cold packs can decrease internal courier lockbox temperatures.

A High-Value Care Curriculum Using Individual and Group Structured Reflection.

OBJECTIVE: One-third of all healthcare dollars are wasted, primarily in the form of clinician-ordered unnecessary diagnostic tests and treatments. Medical education has likely played a central role in the creation and perpetuation of this problem. We aimed to create a curriculum for medical students to promote their contribution to high-value care conversations in the clinical environment. METHODS: At a large university medical center between March 2017 and February 2018, we implemented a 3-phase curriculum combining multimodal educational initiatives with individual and group reflection for third-year medical students during their 12-week long Internal Medicine clerkship rotation. Students were asked to identify examples of clinical decision making that lacked attention to high-value care, propose solutions to the identified situation, and pinpoint barriers to the implementation of effective solutions using a structured reflection framework and then participate in a debrief debate with fellow students. To assess the curriculum, reflective narratives were coded by frequency and codes were compared with one another and with relevant high-value care literature to identify patterns and themes. RESULTS: In total, 151 medical students participated in phase 1 and 119 in phase 3. For phase 2, 126 reflective narratives (94.7% participation rate) comprised 226 problems, 280 solutions, and 179 barriers. CONCLUSIONS: When provided appropriate resources, medical students are able to identify relevant examples of low-value care, downstream solutions, and barriers to implementation through a structured reflection curriculum comprising written narratives and in-person debate.

Outdoor Courier Lockboxes in Summer Are a Significant Source of Preanalytical Error.

OBJECTIVES: To determine the impact of short-term (<4-hour) exposure of summer-like temperatures on lithium heparin (uncentrifuged and centrifuged) samples stored in outdoor courier lockboxes in the Mid-Atlantic United States. METHODS: Healthy adults (n = 8) were recruited to investigate the impact of the short-term exposure of lithium heparin samples (centrifuged and uncentrifuged) inside 2 LabLocker-KF300 courier lockboxes placed outside in direct sunlight during summer. Each courier lockbox was monitored every 5 minutes with a temperature data logger and contained either the standard number (n = 2) of cold packs (cold) or no standard cold packs (warm). Acceptable tolerance limits were defined for each analyte by significant change limit (SCL) analysis (P < .05), as previously described. RESULTS: Significant changes were identified in each study condition for warm and cold lockbox conditions. Aspartate aminotransferase, glucose, lactate dehydrogenase, and potassium commonly crossed SCLs from mean baseline (t0) in the majority of conditions. CONCLUSIONS: Outdoor courier lockboxes are an underrecognized source of preanalytical error.

Cross-Institutional Evaluation of the Abbott ARCHITECT SARS-CoV-2 IgG Immunoassay.

OBJECTIVE: To describe a cross-institutional approach to verify the Abbott ARCHITECT SARS-CoV-2 antibody assay and to document the kinetics of the serological response. METHODS: We conducted analytical performance evaluation studies using the Abbott ARCHITECT SARS-CoV-2 antibody assay on 5 Abbott ARCHITECT i2000 automated analyzers at 2 academic medical centers. RESULTS: Within-run and between-run coefficients of variance (CVs) for the antibody assay did not exceed 5.6% and 8.6%, respectively, for each institution. Quantitative and qualitative results agreed for lithium heparin plasma, EDTA-plasma and serum specimen types. Results for all SARS-CoV-2 IgG-positive and -negative specimens were concordant among analyzers except for 1 specimen at 1 institution. Qualitative and quantitative agreement was observed for specimens exchanged between institutions. All patients had detectable antibodies by day 10 from symptom onset and maintained seropositivity throughout specimen procurement. CONCLUSIONS: The analytical performance characteristics of the Abbott ARCHITECT SARS-CoV-2 antibody assay within and between 2 academic medical center clinical laboratories were acceptable for widespread clinical-laboratory use.