Clinical Performance of Two SARS-CoV-2 Serologic Assays.

BACKGROUND: The recent emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has resulted in a rapid proliferation of serologic assays. However, little is known about their clinical performance. Here, we compared two commercial SARS-CoV-2 IgG assays. METHODS: 103 specimens from 48 patients with PCR-confirmed SARS-CoV-2 infections and 153 control specimens were analyzed using SARS-CoV-2 serologic assays by Abbott and EUROIMMUN (EI). Duration from symptom onset was determined by medical record review. Diagnostic sensitivity, specificity, and concordance were calculated. RESULTS: The Abbott SARS-CoV-2 assay had a diagnostic specificity of 99.4% (95% CI; 96.41-99.98%), and sensitivity of 0.0% (95% CI; 0.00-26.47%) at <3 days post symptom onset, 30.0% (95% CI; 11.89-54.28) at 3-7d, 47.8% (95% CI; 26.82-69.41) at 8-13d and 93.8% (95% CI; 82.80-98.69) at ≥14d. Diagnostic specificity on the EI assay was 94.8% (95% CI; 89.96-97.72) if borderline results were considered positive and 96.7% (95% CI; 92.54-98.93) if borderline results were considered negative. The diagnostic sensitivity was 0.0% (95% CI; 0.00-26.47%) at <3d, 25.0% (95% CI; 8.66-49.10) at 3-7d, 56.5% (95% CI; 34.49-76.81) at 3-7d and 85.4% (95% CI; 72.24-93.93) at ≥14d if borderline results were considered positive. The qualitative concordance between the assays was 0.83 (95% CI; 0.75-0.91). CONCLUSION: The Abbott SARS-CoV-2 assay had fewer false positive and false negative results than the EI assay. However, diagnostic sensitivity was poor in both assays during the first 14 days of symptoms.

Limitations of Free Light Chain Assays caused by the Matrix Effect.

BACKGROUND: Serum free light chain (FLC) assays are used clinically to measure the concentration of κ and λ FLC in patients with suspected or diagnosed plasma cell proliferative disorders. Previous studies have demonstrated a loss of linearity in low concentration ranges of these assays. We hypothesized that this result could be caused by a matrix effect. METHODS: Recovery studies were performed for κ and λ FLC in both serum and saline using the Freelite assay (Binding Site) on a Cobas c502 system (Roche). Samples were analyzed either at the recommended dilution or undiluted. Follow-up studies were performed in varying matrices ranging from 0% to 100% saline. Retrospective patient data were analyzed to assess the impact on reported κ FLC, λ FLC, and κ/λ ratio. RESULTS: FLC in a serum matrix demonstrated underrecovery relative to samples diluted in saline for both κ and λ FLC. Of 255 patient samples with λ FLC measured undiluted (λ FLC <6.0 mg/L), an unexpected gap was observed in patient results between 2.0 and 6.0 mg/L. In addition, 23 patients measured serially with λ FLC between 2.0 and 6.0 mg/L demonstrated dramatic changes in κ/λ ratio, with no changes in κ FLC, likely because of the matrix effect. CONCLUSIONS: The κ and λ Freelite assays exhibit a matrix effect when samples are tested undiluted, which has the potential to affect the κ/λ ratio. Consequently, our laboratory has stopped reporting λ FLC <6.0 mg/L.

Making time for learning-oriented leadership in multidisciplinary hospital management groups.

BACKGROUND: Although the clinical requirements of health care delivery imply the need for interdisciplinary management teams to work together to promote frontline learning, such interdisciplinary, learning-oriented leadership is atypical. PURPOSE: We designed this study to identify behaviors enabling groups of diverse managers to perform as learning-oriented leadership teams on behalf of quality and safety. APPROACH: We randomly selected 12 of 24 intact groups of hospital managers from one hospital to participate in a Safety Leadership Team Training program. We collected primary data from March 2008 to February 2010 including pre- and post-staff surveys, multiple interviews, observations, and archival data from management groups. We examined the level and trend in frontline perceptions of managers' learning-oriented leadership following the intervention and ability of management groups to achieve objectives on targeted improvement projects. Among the 12 intervention groups, we identified higher- and lower-performing intervention groups and behaviors that enabled higher performers to work together more successfully. FINDINGS: Management groups that achieved more of their performance goals and whose staff perceived more and greater improvement in their learning-oriented leadership after participation in Safety Leadership Team Training invested in structures that created learning capacity and conscientiously practiced prescribed learning-oriented management and problem-solving behaviors. They made the time to do these things because they envisioned the benefits of learning, valued the opportunity to learn, and maintained an environment of mutual respect and psychological safety within their group. PRACTICE IMPLICATIONS: Learning in management groups requires vision of what learning can accomplish; will to explore, practice, and build learning capacity; and mutual respect that sustains a learning environment.

Improving patient care through leadership engagement with frontline staff: a Department of Veterans Affairs case study.

BACKGROUND: Leveraging Frontline Expertise (LFLE) is a patient safety intervention for engaging senior managers with the work-systems challenges faced by frontline workers and ensuring follow-up and accountability for systemic change. A study was conducted to assess the ability to refine, implement, and demonstrate the effectiveness of LFLE, which was designed for and tested in private-sector hospitals, in a Department of Veterans Affairs medical center (VAMC), typically a more hierarchical setting. METHODS: LFLE was pilot tested in an urban, East coast-based VAMC, which implemented LFLE in its emergency department and operating room, with the medical/surgical ward and ICU serving as controls. A 20-month multimethod evaluation involved interviews, observation, data-tracking forms, and surveys to measure participant perceptions of the program, operational benchmarks of effectiveness, and longitudinal change in safety climate. RESULTS: Implementation showed fidelity to program design. Participating units identified 22 improvement opportunities, 16 (73%) of which were fully or partially resolved. Senior managers' attitudes toward LFLE were more positive than those of frontline staff, whose attitudes were mixed. Perceptions of safety climate deteriorated during the study period in the implementation units relative to controls. DISCUSSION: LFLE can be implemented in the VA, yield work-system improvements, and increase alignment of improvement aims and actions across hierarchical levels. Yet the results also warn against dangers inherent in adapting improvement programs to new settings. Findings suggest the need for active listening and learning from frontline staff by senior managers and trust building across hierarchical

Front-line staff perspectives on opportunities for improving the safety and efficiency of hospital work systems.

OBJECTIVE: To contrast the safety-related concerns raised by front-line staff about hospital work systems (operational failures) with national patient safety initiatives. DATA SOURCES: Primary data included 1,732 staff-identified operational failures at 20 U.S. hospitals from 2004 to 2006. STUDY DESIGN: Senior managers observed front-line staff and facilitated open discussion meetings with employees about their patient safety concerns. DATA COLLECTION: Hospitals submitted data on the operational failures identified through managers' interactions with front-line workers. Data were analyzed for type of failure and frequency of occurrence. Recommendations from staff were compared with recommendations from national initiatives. PRINCIPAL FINDINGS: The two most frequent categories of operational failures, equipment/supplies and facility issues, posed safety risks and diminished staff efficiency, but have not been priorities in national initiatives. CONCLUSIONS: Our study suggests an underutilized strategy for improving patient safety and staff efficiency: leveraging front-line staff experiences with work systems to identify and address operational failures. In contrast to the perceived tradeoff between safety and efficiency, fixing operational failures can yield benefits for both. Thus, prioritizing improvement of work systems in general, rather than focusing more narrowly on specific clinical conditions, can increase safety and efficiency of hospitals.