Development of an antimicrobial stewardship program in an integrated healthcare system.

PURPOSE: The development of an inpatient antimicrobial stewardship program (ASP) in an integrated healthcare system is described. SUMMARY: With increasing national focus on reducing inappropriate antimicrobial use, state and national regulatory mandates require hospitals to develop ASPs. In 2015, BJC HealthCare, a multihospital health system, developed a system-level, multidisciplinary ASP team to assist member hospitals with ASP implementation. A comprehensive gap analysis was performed to assess current stewardship resources, activities and compliance with CDC core elements at each facility. BJC system clinical leads facilitated the development of hospital-specific leadership support statements, identification of hospital pharmacy and medical leaders, and led development of staff and patient educational components. An antimicrobial-use data dashboard was created for reporting and tracking the impact of improvement activities. Hospital-level interventions were individualized based on the needs and resources at each facility. Hospital learnings were shared at bimonthly system ASP meetings to disseminate best practices. The initial gap analysis revealed that BJC hospitals were compliant in a median of 6 ASP elements (range, 4-8) required by regulatory mandates. By leveraging system resources, all hospitals were fully compliant with regulatory requirements by January 2017. CONCLUSION: BJC's ASP model facilitated the development of broad-based stewardship activities, including education modules for patients and providers and clinical decision support, while allowing hospitals to implement activities based on local needs and resource availability.

12th GCC Closed Forum: critical reagents; oligonucleotides; CoA; method transfer; HRMS; flow cytometry; regulatory findings; stability and immunogenicity.

The 12th GCC Closed Forum was held in Philadelphia, PA, USA, on 9 April 2018. Representatives from international bioanalytical Contract Research Organizations were in attendance in order to discuss scientific and regulatory issues specific to bioanalysis. The issues discussed at the meeting included: critical reagents; oligonucleotides; certificates of analysis; method transfer; high resolution mass spectrometry; flow cytometry; recent regulatory findings and case studies involving stability and nonclinical immunogenicity. Conclusions and consensus from discussions of these topics are included in this article.