Volume 2025 | No. 2
SURVEYOR
PHARMACY
Compliance tips for:
ٝ Aseptic technique manipulation in accordance with USP Chapter <797> for personnel with direct oversight. ٝ Documentation of didactic training/education. ■ During review of personnel files and while observing compounding for compliance with competency assessments, surveyors noted these errors: ٝ Beginning to compound without repeating a failed GFT/media fill. ٝ Moving in and out of the hood without re-sanitizing gloves. ٝ Blocking first air. ٝ Stopping hand hygiene at the forearm and not reaching the elbow. ■ Training and competency assessments are being completed, but not within the timeframes required per USP <797> standards. ■ Before non-compounding staff are allowed entry into the classified area, there is no documentation of required training and assessments as defined in facility policies and procedures.
■ Policies, procedures, and job descriptions must reflect the current requirements of USP <797> for designation of an individual as responsible for pharmacy operations and competency of compounding personnel with regard to all aspects of preparing sterile compounds. ■ Audit the designated person’s personnel record to ensure all responsibilities required by USP <797> are addressed in the job description. ■ At least every 12 months, the designated person(s) documents a review of the policy and procedure manual to ensure it reflects current practices. ■ Create a personnel file audit tool that includes auditing job description for the DP(s). Ensure the job description addresses all responsibilities required by the USP chapter(s). ■ Provide opportunities for the designated person(s) to expand their knowledge through live and on-demand webinars, national conferences, and written literature.
Nerd Newbies (understand the requirement)
Nerd Apprentices (audit for excellence) continued
Nerd Trailblazers (prepare the path for others)
Compliance tips for:
DRX4-7C Frequency of the citation: 39%
■ This standard requires training and competencies for sterile compounding personnel. D idactic training is conducted initially and at least every 12 months. ٝ Aseptic technique validation is conducted: о At least every six months for Category 1 & 2 compounded sterile preparations (CSPs) о At least every three months for Category 3 CSPs for staff actively compounding. ٝ For the designated person and personnel with direct oversight of compounding personnel training and aseptic technique validation competency assessments are conducted initially and at least every 12 months. ■ At a minimum, all affected personnel must demonstrate knowledge in: H and hygiene and garbing.
Nerd Newbies (understand the requirement)
Overview of the requirement: Written policies and procedures define the minimum education, training, competencies licensure, certification, and experience required for all sterile compounding personnel. This includes employees who independently perform compounding, staff with direct oversight, and/or those who are allowed entry into the classified area. Comment on deficiencies: Compliance is evaluated through staff interviews and review of policies, procedures, the competency assessment program, and personnel files. Most deficiencies are related to issues with competencies, particularly gloved fingertip/thumb (GFT) sampling and direct compounding area (DCA) surface sampling. Many organizations had not updated their processes to match current USP <797> requirements.
Examples of ACHC Surveyor findings:
ٝ Cleaning, disinfection, and application of a sporicidal agent. ٝ Principles of movement of materials and people within the
■ Personnel records did not contain evidence of: ٝ Post media-fill GFT and DCA surface samples. ٝ Competency assessment documentation of lot, expiration of media, and the date/time samples
compounding area. ٝ Aseptic technique.
were placed in the incubation environments. ٝ Calculations, measuring, and mixing training.
ٝ Achieving and/or maintaining sterility. ٝ Proper use of equipment and PECs. ٝ Documentation of the compounding process. ٝ Principles of HEPA-filtered unidirectional airflow within the ISO Class 5 area.
ٝ Training and testing on principles of movement of materials and personnel within the compounding area, as well as proper use of primary engineering controls (PECs).
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