Volume 2025 | No. 2
SURVEYOR
PCAB (COMPOUNDING PHARMACY)
SECTION 3: PERSONNEL TRAINING AND COMPETENCY TCRX3-B Frequency of the citation: 28%
Compliance tips for: Nerd Newbies
A designated person (DP) must be identified and have a written job description. The DP maintains oversight over the pharmacy’s compounding processes and personnel. The standard outlines specific responsibilities that vary depending on whether the pharmacy conducts sterile or non-sterile compounding (or both). Examples include: ■ Overseeing a training program (or delegating the training program to an assigned trainer). ■ Taking immediate corrective action if deficient compounding practices are observed. ■ Reviewing and approving all policies and procedures initially and every 12 months. ■ Ensuring compounding areas meet all standards and requirements. ■ Evaluating and documenting the QA and QC programs at least every 12 months. ■ Determining the integrity and quality of compounded preparations when temperature excursions occur. ■ Establish and implement written policies and procedures to identify a designated person or persons and clearly define the responsibilities of leadership and all compounding personnel. ■ Audit personnel files to ensure that the DP’s job description includes all associated responsibilities. ■ Develop a checklist for auditing personnel files and include the requirement for the DP job description. ■ Take the checklist a step further by including each DP responsibility and requiring verification that specific elements are present.
(understand the requirement)
Overview of the requirement: Sterile compounding personnel are required to complete training/education prior to being assigned work independently. Policies and procedures require competencies, documented semiannually (Category 1 and 2) and quarterly (Category 3), in areas consistent with the risk level of the compounding. Note: This standard applies to sterile compounding only. Comment on deficiencies: Compliance is evaluated through review of policies and procedures, competency assessments, and personnel files. Surveyors may also conduct staff interviews. Most deficiencies were related to missing elements for personnel with direct sterile compounding oversight, particularly documentation of aseptic technique validation, including gloved fingertip/thumb sampling, and media fill testing. Examples of ACHC Surveyor findings: ■ The pharmacy has developed a training for the USP <797> core skills, but this is not documented. ■ Personnel records reviewed for those with direct sterile compounding oversight were missing: ٝ Sterile compounding trainings. ٝ Gloved fingertip/thumb (GFT) samplings (including initial). ٝ Media fills and post-media fill GFT samplings. ٝ DCA surface samplings. ■ The pharmacy makes Category 3 compounded sterile preparations (CSPs). The media fill process is being performed every 6 months but should be performed every 3 months for Category 3 compounding for people actively compounding. In contrast, people with direct oversight require GFT, media fill, and surface sampling of the DCA at least every 12 months.. ■ The aseptic technique validation process does not: ٝ Have enough units being made to meet USP <797> guidelines. ٝ Replicate the most strenuous process. ٝ Include surface sampling of the DCA after completion. ٝ Visual observation of nail cleaning, hand cleansing, and use of an alcohol hand rub. ■ One pharmacist has the training and ongoing documentation to oversee sterile compounding and provide direct oversight. No additional personnel have been trained to cover when the pharmacist is not available (e.g., out sick, on vacation) and when pharmacists are assigned on-call responsibilities.
Nerd Apprentices (audit for excellence)
Nerd Trailblazers (prepare the path for others)
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