Designing a microbiological monitoring program for compounding facilities.

PURPOSE: We describe the evolution of a large multicenter health system's microbiological monitoring program to improve standardization of viable sample collection practices; results review, interpretation, and response; and record keeping. We also describe lessons learned and considerations for other organizations considering microbiological monitoring program enhancements. SUMMARY: Developing a robust microbiological monitoring program requires policy and procedure development; training and education of staff involved in viable sample collection, results interpretation, and investigations; establishing a robust sampling plan; reviewing trend data; reviewing systems data; and conducting investigations. Well-defined policies and procedures ensure consistent response to "out of level" (ie, violative) sampling results. Staff education ensures staff involved in microbiological monitoring are educated on adequate sampling techniques and microbial contamination sources and mitigation strategies. Thorough record keeping is essential for microbiological monitoring sampling activities and ongoing systems monitoring. The records should include results, investigations, assessments, recommendations, and records of completed follow-up actions. CONCLUSION: Facilities management requires a comprehensive microbiological monitoring and systems monitoring plan. In health systems with multiple sites, a centralized oversight and management program may be beneficial to standardize records, response planning, and overall control of controlled compounding environments.

Development of a sterile compounding training and competency program at a large academic medical center.

PURPOSE: This article is one of the 5 articles describing steps taken to enhance sterile compounding compliance at a large, multisite academic medical center. This article focuses on the development of a comprehensive personnel training and assessment program for sterile compounding. SUMMARY: Increased regulatory oversight and the release of new United States Pharmacopeia chapters motivated the reenvisioning of the medical center's sterile compounding personnel training and assessment program. The main challenges facing any entity undertaking sterile compounding include identification of compounding staff, development of policies and procedures, and baseline and ongoing training including observational competency assessments and record keeping. These challenges are exacerbated by high work volumes and variation in compounding practices encountered within a large multisite institution. Our organization developed a team of specialized pharmacists and pharmacy technicians to implement and enforce changes promoting the safe production and use of compounded sterile products and meet rising regulatory requirements. This team worked within various operational areas to customize purchased policies and procedures and group compounding staff based on training needs. The team performs ongoing personnel monitoring and training of new compounders in a shared training space. Challenges encountered and future considerations for program enhancement are described. CONCLUSION: Implementation of standards and enforcement of staff behaviors in a large academic medical center is perhaps best completed by a team of highly trained experts working in collaboration with supervisors and using a dedicated training and testing space, as evidenced by the success of the described program in overecoming past challenges.

A compounding compliance team at an academic medical center.

PURPOSE: Highly publicized safety issues arising from poor sterile compounding practices in facilities around the United States have garnered substantial attention in recent years. This attention has led to increased scrutiny of health systems by regulatory bodies, new regulatory requirements, and changes to existing regulations or their interpretation. Health systems are often resource constrained, and the added work resulting from this scrutiny challenges pharmacy departments in meeting regulatory requirements and United States Pharmacopeia chapter 797 standards for sterile compounding. This article describes the creation of a dedicated compounding compliance team (CCT) and the team's responsibilities in support of pharmacy operations in achieving compliance with those standards. SUMMARY: Visits to our organization by several regulatory bodies resulted in findings that required substantial work in order to achieve compliance with sterile compounding standards. Given the number and complexity of findings and the need for timely resolution, it was felt that specialized staff were needed to understand, evaluate, and correct identified deficiencies and help the already overburdened staff and leadership comply with existing standards. A CCT was formed, and work was simultaneously initiated on ensuring proper credentialing and training of all compounding staff, development of standard operating procedures, improvements in facilities, environmental monitoring, equipment certifications, practice auditing, and documentation. Key activities of the team included strategic planning, building relationships, communicating with stakeholders, self-education, and record keeping. Key partners included environmental services, facilities, and infection prevention and control personnel and departmental staff and leaders. CONCLUSION: The formation and collaborative work of a CCT at an academic medical center was successful in changing the culture of the organization and achieving compliance during visits from several regulatory agencies.