Volume 2025 | No. 2
SURVEYOR
PCAB (COMPOUNDING PHARMACY)
SECTION 4: PATIENT COMMUNICATIONS TCRX4-A.01 Frequency of the citation: 28%
■ There was no documented evidence of the required training and assessments before non- compounding staff are allowed entry into the classified area(s). Non-compounding staff include third-party cleanroom certification professionals, maintenance technicians, personnel responsible for restocking and cleaning, inspectors, etc.).
Compliance tips for:
This standard requires training and competencies for sterile compounding personnel. Didactic training is conducted initially and every 12 months. For staff who are actively compounding, aseptic technique validation is conducted every six months for Category 1 & 2, and every three months for Category 3. Staff with direct oversight are evaluated for compliance with USP <797>, including: ■ Hand hygiene and garbing. ■ GFT sampling post-hand hygiene and garbing, and post-media fill. ■ Aseptic technique manipulation including visual observation, media fill testing, and DCA surface sampling. ■ Review personnel files and confirm the inclusion of all aspects of compounding training and testing as required by the updated USP <797> and state board of pharmacy regulations. (For example, include written information documenting the GFT and media fill incubation times and temperatures.) ■ Audit policies and procedures for the required initial and ongoing competency assessments for compounding personnel and personnel with direct oversight. These team members must demonstrate knowledge and competency in: ٝ Post-hand hygiene, garbing, and gloving. ٝ Aseptic technique visual observation. ٝ Media fill testing, post-media fill GFT sampling, and DCA surface sampling. ■ Ensure training and competencies are conducted at the correct cadence for the category of CSPs compounded. ■ Pay close attention to media fill testing and verify the presence of all required components. Designate alternate employees to assist the designated person with conducting training and assist with competency assessments.
Overview of the requirement: Policies and procedures define the content of an accurate record for each patient.
Nerd Newbies (understand the requirement)
Comment on deficiencies: Surveyors assess compliance through review of policies and procedures and patient/client records. Most deficiencies noted incomplete documentation of pertinent patient information. Examples of ACHC Surveyor findings: ■ No policy was found addressing the content of the client/patient record. ■ The frequency and parameters for updating patient/client information are not specified in the policy. ■ The pharmacy does not attempt to obtain the following: ٝ Documented drug/environmental allergies. ٝ Other patient medications, both prescription and nonprescription. ٝ Patient health conditions/disease states. ٝ Treatment diagnosis. ٝ Other relevant information such as height and weight. ■ There was no documentation that client/patient refused to provide client/patient-specific information when requested.
Nerd Apprentices (audit for excellence)
Nerd Trailblazers (prepare the path for others)
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