Volume 2024 | No. 2
SURVEYOR
PCAB COMPOUNDING CLINICAL LABORATORY
SECTION 3: PERSONNEL TRAINING AND COMPETENCY TCRX3-B Overview of the requirement: Note: This standard applies to sterile compounding only.
PCAB is a brand of ACHC focused on accreditation of compounding pharmacies subject to the regulations of the United States Pharmacopeia Convention (USP). PCAB accreditation recognizes these pharmacies for quality and consistency in producing sterile and nonsterile compounded medications.
Policies and procedures require both sterile compounding personnel to complete training/education prior to being assigned work independently. Required competencies are documented annually and/or semiannually, in areas consistent with the risk level of the compounding. Compliance is evaluated through review of policies, procedures, the competency assessment program and associated logs, and response to interviews. Most deficiencies noted inadequate competency assessments and missing documentation.
Comment on deficiencies:
PCAB ACCREDITATION
Frequency of citation:
31%
Services Non-Sterile Compounding Hazardous Drug Handling (Ref. USP <800>)
Examples of surveyor findings:
n The forms used in the pharmacy’s software did not allow for the documentation of the temperature of the incubator at the time the media fill was pl aced In the incubator and did not include the incubation range requirements, so it could not be determined from the records how the media was incubated. n The pharmacy lacked documentation of a competency assessment for cleaning and disinfecting procedures for all appropriate personnel. n The media fill process did not include the most challenging or stressful conditions the compounder may encounter. n The media fill result form is missing: Expiration date, lot #, and manufacturer. Documentation of growth or no growth during the time of incubation. Documentation of the date when test units were moved from one incubator to the other. n The technique used for performing gloved fingertip/thumb sampling (GFT) was touching the plate instead of rolling the fingertips over the plate. n Personnel files lacked: Initial GFT competencies resulting in zero colony forming units from both hands following three separate and complete evaluations in a row. Annual didactic training on hand hygiene and garbing. Evidence of initial didactic & written training/competency assessments prior to personnel performing or overseeing sterile compounding.
Sterile Compounding Hazardous Drug Handling (Ref. USP <800>)
FREQUENT DEFICIENCIES IN COMPOUNDING PHARMACIES
100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0%
TCRX3-B TCRX4-A.01 TCRX5-D TCRX5-F TCRX5-G TCRX6-C TCRX6-E TCRX6-G
TCRX6-I
TCRX6-L
Personnel Training and Competency
Provision of Care and Record Management
Quality Outcomes/Performance Improvement
Patient Communications
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