Hospitals today face an increasing amount of federal and state oversight and these regulatory requirements reach into every corner of operations. One of the most impactful regulations in recent years was USP Chapter <797>: Pharmaceutical Compounding - Sterile Preparations. The overall intent of USP 797 is to prevent patient harm through minimum practice and quality standards expected from any entity or individual involved in the storage, handling, preparation and transport of compounded sterile preparations (CSPs).
Since its publication, compounding pharmacies have made progress in meeting the myriad compliance demands of USP 797, yet many facilities are still struggling to fully comply. This struggle may be due in part that USP 797 affects nearly every step of the sterile compounding process: having policies in place for each compounding site, ensuring proper facility environmental design and engineering controls, documenting compounding activities and developing staff training and competency evaluations.
The healthcare industry has embraced the benefits of electronic technology in many areas to enhance patient care, improve the efficiency and efficacy of care delivery and stay current with regulations governing patient care. Because of the rigorous demands of USP 797 and the penalties associated with non-compliance, many compounding pharmacies have decided to embrace and leverage electronic technology systems to improve their USP 797 compliance and enhance staff competencies.
Automated task management, schedules and reports. By eliminating the manual tracking and documentation processes that make reporting so time consuming, digital solutions allow staff to spend more time on higher value initiatives. At the same time, the automated aspect reduces errors, improving compliance with scheduling and reporting requirements.
Integrated site-specific quality assurance plans. Automated solutions often provide site-specific quality assurance plans that ensure the facility complies with the environmental design and engineering control rules appropriate to the site’s level of risk. This customization enables facilities to quickly identify any design or control deficiencies and determine what corrective actions they need to take.
Auto-notification of overdue tasks and exceptions to staff and supervisors. Alerts sent to pharmacy staff ensure that essential tasks do not slip through the cracks on busy days, while dramatically reducing the time taken by manual review of checklists. Notifications to supervisors enable them to monitor USP 797 compliance and quickly take corrective action.
Instantaneous out-of-range alerts and remediation recommendations. Automated alerts immediately draw attention to problems and enable staff to make adjustments in real time, while remediation recommendations help even new staff know exactly what to do.
Staff training and evaluation. Digital solutions can automate, integrate and streamline procedures for assessing USP 797 competence for technicians, pharmacists and physicians. These systems enable a facility to ensure staff have the necessary training and easily document their levels of competence for compliance purposes.
Simplifi 797 provides all these tools and more in a quality pharmacy management system. In addition, it offers a complete set of 31 expert-based policies and procedures and 25 forms, developed by industry expert Eric Kastango, which promote staff competency and a culture of compliance.
What tools for USP 797 have you found most useful? What do you wish your system provided? Let us know in the comments below.