Volume 2025 | No. 2
SURVEYOR
PCAB (COMPOUNDING PHARMACY)
SECTION 1: ORGANIZATION AND ADMINISTRATION TCRX1-D Frequency of the citation: 31%
Overview of the requirement: The organization’s leadership is required to identify a designated person (DP) or persons as responsible and accountable for preparing, storing, packaging, and transporting compounded preparations (sterile and/or non-sterile). The designated person(s) must receive documented training specific to the role. Comment on deficiencies: Compliance is evaluated through review of written policies, procedures, and personnel files. Surveyors noted that many organizations had not identified a designated person (DP) and were missing both job descriptions and policies. Examples of ACHC Surveyor findings: ■ No employee has been formally identified as the designated person. No written policies and procedures outline the DP’s job. ■ PIC was verbally identified as the designated person, but the responsibilities for this role were not defined in a job description. ■ The job description for the DP is missing: ٝ Mandate that the designated person determines whether a Compounded Sterile Preparation (CSP) is expected to retain its integrity and quality when temperature excursions occur when compared to USP <659>. ٝ Stipulation that this person ensures there is a designated area for non-sterile compounding. ٝ The requirement to include the responsibilities associated with ensuring a QA/QC Program is both in place and reviewed annually. The DP must review policies and procedures annually as well.
PCAB (COMPOUNDING PHARMACY) ACCREDITATION Services Non-Sterile Pharmacy Compounding Sterile Pharmacy Compounding Hazardous Drug Handling PCAB
FREQUENT DEFICIENCIES IN COMPOUNDING PHARMACIES
60%
50%
40%
30%
20%
10%
0% TCRX1-D TCRX3-B TCRX4-A.01 TCRX5-F TCRX5-G TCRX6-C TCRX6-D TCRX6-E
TCRX6-H TCRX7-B
Organization and Administration
Patient Communications
Quality Outcomes/ Performance Improvement
Provision of Care and Record Management
Hazardous Drug Handling PCAB
Personnel Training and Competency
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