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1111 DUFF AVENUE

AMES, IA 50010

INFECTION CONTROL PROGRAM

Tag No.: A0749

I. Based on observation, document review, and staff interviews, the hospital's administrative staff failed to ensure the central sterilization staff members followed the manufacturer's directions for 1 of 1 bottle of Metricide OPA Plus test strips. The hospital's administrative staff identified approximately 18 times during June 2017 that the hospital staff used Metricide OPA in the central sterilization area.

Failure to follow the manufacturer's directions resulted in the staff leaving the bottle of Metricide OPA Plus open, potentially resulting in the test strips failing to display an accurate reading. Failure of the testing strips to accurately display the minimum effective concentration of the active ingredient in Metricide OPA could potentially result in the Metricide OPA Plus lacking sufficient strength to kill all infectious organisms (bacteria, viruses, or fungi) and potentially spread infections between patients.

Findings include:

1. Observations during a tour of the central sterilization processing area on 7/18/17 at 9:50 AM revealed 1 of 1 bottle of Metricide OPA Plus test strips. The bottle was sitting on a shelf with the lid off the container. The bottle contained 68 test strips, with a new bottle containing 100 test strips. Review of the bottle's label revealed in part, "STORAGE IMPORTANT: Keep cap tightly closed."

2. Review of the "High level disinfection logbook - Metricide OPA" revealed the central sterilization staff members last used the Metricide OPA Plus test strips on 7/17/17 (the day prior to the observations).

3. During an interview at the time of the tour, the Sterile Processing Clinical Supervisor stated he did not know when the staff last used the bottle of Metricide OPA Plus test strips. The Sterile Processing Clinical Supervisor acknowledged the findings and agreed the central sterilization staff members should have placed the lid on the bottle of Metricide OPA Plus test strips after they used the bottle.