HospitalInspections.org

Bringing transparency to federal inspections

450 E SIGLER AVENUE

MEMPHIS, MO 63555

PATIENT CARE POLICIES

Tag No.: C1016

Based on policy review, review of the United States Pharmacopeia (USP) Chapter 797, observation, and interview, the facility failed to ensure Outpatient Infusion Nurses provided a segregated compounding area (SCA, a separate area designated for drug compounding) free of paper (particle shedding products with the potential for contamination). This failure had the potential to increase the risk of cross-contamination and increased the risk of harm to all patients that received compounded medications. The facility census was one Acute Care patient and three Swing Bed patients for a total patient census of four.

Findings included:

1. Review of the facility's policy titled, "Antineoplastic (medication used to treat cancer) Medication Preparation," dated 05/21/2021, showed in part staff directive: The purpose is to provide stringent guidelines for employees occupationally exposed to antineoplastic drugs and the preparation of those antineoplastic agents in compliance with U.S. Pharmacopeia.

Review of the USP, Chapter 797, dated 2013, showed particle shedding objects (pencils, corrugated cardboard, paper towels, and cotton items) were prohibited in the SCA.

2. Observation on 07/11/23 at 1:36 PM of the facility's SCA showed:
- The Compounding Aseptic Containment Isolator (CACI, provided a safe and clean environment for compounding of hazardous, sterile drug preparations in compliance with USP 797 criteria) contained five large metal magnetic paper clips located along the CACI's upper edge with various sizes and types of paper hanging down that touched the surface of the CACI.
- A silver table with a bottom shelf contained 11 boxes (partical shedding) of various supplies and one cardboard box (partical shedding) with supplies located to the left of the CACI.
- The second ceiling tile after you enter the SCA and to the right of the CACI contained a scraped area with a small irregular piece of tile material (partical shedding) hanging down.

3. During an interview on 07/11/23 at 1:36 PM, Staff N, Registered Nurse, Outpatient Infusion Nurse, acknowledged:
- The five large metal magnetic paper clips on the CACI with paper hanging down and touching the CACI's surface.
- The 11 boxes of supplies and one cardboard box with supplies located on the bottom shelf of the table located to the left of the CACI. Staff N stated staff questioned if boxes and cardboard boxes with supplies could be located in the SCA and staff was looking for a solution for a place to store the supplies.
- The ceiling tile contained a scraped area in the tile with a small piece of material from the tile hanging down