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5656 BEE CAVES ROAD, SUITE M-302

AUSTIN, TX 78746

FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE

Tag No.: A0724

Based on observation, review of documents, and interview, the endoscope reprocessing equipment, used to check the accuracy of equipment, was not maintained to ensure an acceptable level of safety and quality.

Findings:

Facility policy titled "Handling and Cleaning of Endoscopy Instruments" (CS-1011) reviewed 4/22, stated in part, "Olympus OER logbook in Central Sterile Department for sterilization cycles.
Scope Sterilization Log
-Affix patient label to the sheet corresponding with the digital readout."

Olympus Endoscopy Repressor OER-Pro Operation Manual partly stated, "User qualifications ...operator of this equipment must be sufficient trained in reprocessing of endoscopes..."

During the tour of the central sterilization department on the morning of 4/11/23, review of the logbooks for the Olympus OER AER (automated endoscopy reprocessor) used for calibrations of solution and reprocessing scopes revealed incomplete documentation on the logs in the months January -April 2023. There was no documentation related to staff training in the use of the equipment as required in the manufacturer's manual for the staff who used the equipment (Staff #5, 7, and 8).

Facility administrative staff #5 and staff #9 confirmed above findings as the tour and inspection occurred on the morning of 4/11/23.