A Training Program Addresses Challenges in USP <797> Personnel Competency Evaluations at a Multisite Institution

The United States Pharmacopeia (USP) general chapter <797> requires personnel competency evaluations for staff who either compound category 1, category 2, or category 3 compounded sterile preparations or have direct oversight of compounding personnel.¹ These evaluations are required before compounding activities commence and must continue at a specific frequency that depends on compounding and oversight activities. The competency evaluations include garbing and hand hygiene evaluations as well as aseptic manipulations. UC San Diego Health created a proctor training program to address the personnel competency evaluation requirements that will take effect on November 1, 2023.

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USP <797> 2023 requires a 2-stage incubation method for gloved fingertip and thumb sampling, media fills, and surface samples. The temperature and duration of the incubation depend on which competency assessment is being evaluated. When using a sampling media device, gloved fingertip and thumb samples or surface samples must be incubated at 30 to 35 °C for no less than 48 hours followed by 20 to 25 °C for no less than 5 additional days.1 Media fill bags for aseptic manipulations must be incubated at 20 to 25 °C and 30 to 35 °C for a minimum of 7 days at each temperature.¹ As the order of incubation temperatures for the media fill must be described in standard operating procedures, the elements of handling the 2-stage incubation are left to each entity to determine the respective workflow.

Although the competency evaluators at our institution were well versed in handling personnel competency assessments involving 1 incubator, the addition of a second incubator, increased documentation requirements, and the physical movement of media from 1 incubation stage to another at the correct frequency prompted the need to address training for competency evaluators. As mentioned by Penzien et al, navigating and implementing these standards can be logistically challenging at a multisite institution because of fluctuations in workload and compounding work practices.²

The first step in addressing competency evaluator training involved creating a work group of members at multiple sites from our institution. The work group consisted of 2 pharmacist specialists, 2 pharmacy supervisors, and 2 pharmacy managers. The training program for the competency evaluators was composed of 5 elements: a didactic presentation, mock hand hygiene and garbing evaluations with associated gloved fingertip and thumb sampling, multiple mock media fill challenges with an associated surface sample of each direct compounding area, a written exam, and periodic audits of the competency evaluations.

The didactic presentation covered changes to the personnel competency evaluations, including the rationale behind the new changes, how to take a surface sample of the direct compounding area, cleaning and disinfecting procedures, documentation requirements, and action levels. Since all samples must be placed in an incubator for the 2-stage incubation, we presented strategies on when to move each respective media device. A competency for the mock sessions was developed and included general concepts of aseptic work practices, visual observations, gloved fingertip sampling, simulated media fills for nonhazardous and hazardous sterile compounding, surface sampling of the direct compounding area, cleaning, recording results, and what to do if any samples had exceeded action levels. Intentional deviations were also made throughout the sessions where proctors-in-training had to provide immediate corrective actions to the person being evaluated. The written exam consisted of questions that demonstrated knowledge of key concepts provided during the training, such as starting temperatures for each stage of incubation and photos that tested principles of first air and elements of reading media results.

After the first 4 elements of the program were completed, the staff member was qualified as a proctor for the personnel competency evaluations. The final program element includes periodic audits of the personnel competency evaluations, and an auditing tool was developed to ensure each proctor is fulfilling requirements of the assessment. Auditing provides an additional layer of quality to help ensure that staff, including the proctors, are not bypassing any steps of the competency evaluation. Informing both proctors and all staff who complete the competency evaluations has also increased transparency as staff are aware that the audit can take place at any time during their competency evaluation.

In conclusion, implementing a proctor training program has helped standardize how the competency evaluators are proctoring competency assessments. A key aspect of developing a successful training program is to collaborate with proctors to develop a standardized workflow that is feasible and meets all expectations. In addition to developing competency evaluator skill sets in handling the new requirements of USP <797>, a training program for competency evaluators has standardized personnel competency evaluations across our health system.

References

1. Pharmaceutical compounding — sterile preparations. United States Pharmacopeia. Accessed June 14, 2023. https://www.usp.org/compounding/general-chapter-797

2. Penzien CE, Tharp JC, Mulzer K, Rurka C, Abbas C, Chaffee BW. Development of a sterile compounding training and competency program at a large academic medical center. Am J Health Syst Pharm. 2020;77(24):2089-2100. doi:10.1093/ajhp/zxaa326

About the Authors

Jaclyn M Jaskowiak, PharmD, BCPS, BCSCP, is an inpatient pharmacist specialist and health sciences clinical instructor at University of California (UC) San Diego Health.

Sam Martinez, PharmD, BCOP, BCPS, is a pharmacy manager and an associate clinical professor at UC San Diego Health.

Stephanie Truong, PharmD, BCPS, is an inpatient pharmacy supervisor at UC San Diego Health.

Han Dinh, PharmD, BCPS, is an inpatient pharmacy supervisor at UC San Diego Health.

Mitchell Vitale, PharmD, is an inpatient pharmacy manager at UC San Diego Health.