Category: Federal Forum Posters
Purpose: Hospital pharmacies currently face an assortment of compliance issues related to the USP general chapters <797> and <800> for compounded sterile preparations (CSP) and hazardous drug handling. This quality improvement (QI) project utilizes comprehensive gap analysis to develop a quality assurance (QA) program which addresses clinical operations, personnel training and competencies, standard operating policies (SOPs), as well as establishing a self-assessment tool prior to the December 1, 2019 deadline. The outcomes of the project will further set parameters for QA and QI as it addresses the minimum requirement, identifies current issues in practice, and makes corrective actions.
Methods: The Institutional Review Board (IRB) determined the project as non-research QI activity. Evaluations of current and target state will identify core elements of USP <797> and <800>, including training, core competencies, environmental metrics, personnel metrics, protocol requirements, workflow and revisions denoted by the facility management aligning with the official USP implementation date. The gap analysis template will identify the category of criteria (must, should, may), facility status (meeting/not meeting standard), assigned responsible staff, and target completion dates with plan. This template will clarify which requirements pertain to the most recent revisions of USP <797>, USP <800>, and local policies/directives. Noted citations will require additional review of VA policies to isolate protocol discrepancies. Items will then be prioritized based on the breadth of issue(s) and number of internal/external service(s) required to mediate issue(s). Implementation and corrective action will be subject to rapid experimentation to test the strength of the new countermeasure(s). Data collection and assessment from the rapid experimentation will be provided to staff and expressed in a visual tool. This will compare the success rates of rapid experiments to identify what categories for improvement worked well to address the continued advancement in CSP using the available resources.
Results: not applicable
Conclusion: not applicable
Brandi Gore– PGY1 Rural Health Pharmacy Resident, VA Sierra Nevada Health Care System, Reno, NV