Volume 2025 | No. 2
SURVEYOR
FROM THE PROGRAM DIRECTOR
PHARMACY
Infusion pharmacies encountered unique challenges in establishing sterile compounding compliance. The deficiencies for this pharmacy service are covered below. Most standards on pages 30-41 also apply to infusion, so be sure not to overlook that content. This year we have the first 12 months of data since USP <797> updates from November 2023 were incorporated within ACHC Standards.
SECTION 4: HUMAN RESOURCES MANAGEMENT DRX4-2M Frequency of the citation: 24%
Overview of the requirement: The organization defines accountability for preparing, storing, packaging, and transporting compounded sterile preparations (CSP) and designates an individual or individuals as responsible for the personnel involved in these processes. Comment on deficiencies: Compliance is assessed by reviewing policies and procedures and personnel records. Most findings indicated that the pharmacy had not made updates to reflect the currently enforceable edition of USP <797>. Policies did not include the requirement to name a designated person or persons and job descriptions lacked required elements. Examples of ACHC Surveyor findings: ■ Policies and procedures did not include the requirement for leadership to identify a designated person and to define the responsibilities of the role. ■ The organization has not identified a designated person or persons nor defined the responsibilities of leadership for personnel involved in CSPs. ■ The designated person’s job description did not include all responsibilities outlined in USP <797>. Missing elements included: ٝ A formal, written QA/QC Program. ٝ Training, experience, responsibility, and authority in QA. ٝ Identification of the dynamic operating conditions in the compounding area that reflect the largest number of personnel and highest complexity of compounding expected during routine operation. ■ The designated person (DP) was not aware of some of the required documentation that should be included with the six month reports (certifier equipment list and their calibration, a dynamic smoke test, COA for media fill used in surface sample testing) per USP <797>. Reports that surveyor reviewed were not dated or signed by the person in charge as proof of review. ■ The pharmacy has designated two individuals to perform the responsibilities of the designated person, however, only one of the individuals had a signed job description for the DP responsibilities. ■ The identified DP stated that he has not been responsible for the review of all certification records to ensure the classified environments meets the minimum requirements of USP <797>.
Caroline Girardeau PharmD, MBA, PMP, BCPS Program Director
FREQUENT DEFICIENCIES IN INFUSION PHARMACIES
60%
50%
40%
30%
20%
10%
0%
DRX4-2M DRX4-7C DRX7-8F
DRX7-8N DRX7-8O DRX7-8P.01
DRX7-8P.02 DRX7-9B
Human Resource Management
Provision of Care and Record Management
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