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Tag No.: A0750
Based on document review and interview, the facility failed to inspect surgical instruments and segregate broken, stained, or rusted instruments for 9 of 15 surgical sets to be used in surgery for the month of July 2024.
Findings include:
1. Facility Policy titled, Assembly - Surgical Sterile Processing, PolicyStat ID 14494787, last approved 08/2024, indicated under POLICY, Prior to sterilization, all instrumentation should be inspected for cleanliness and functionality. Instruments must be clean in order for sterility to be achieved, and to assist in preventing infection. Instruments should function properly in order to prevent actual or potential patient injury. Instrument trays and sets should be assembled using standardized procedures to ensure best practices are learned and followed consistently. Instrument inspection should be performed:
1. After each use.
2. To ensure cleanliness and proper functionality.
3. To identify missing parts.
4. Using a lighted magnifying glass.
5. To identify and segregate broken, stained, or rusted instruments.
6. When new instruments are received.
2. Review Infection Control data for July 2024 indicated that there was 1 case of bioburden from EP Lab on 07/19/2024. Review of Sterile Central Electrophysiology Lab sets returned to Central Sterile for processing indicated the following:
a. On 07/12/2024, 1 surgical case was performed, 1 case was cancelled due to surgical instrument contamination and 4 surgical sets from Electrophysiology Lab were sent to Central Sterile for processing.
b. On 07/19/2024, 5 surgical cases were performed, 8 surgical sets from Electrophysiology Lab were sent to Central Sterile for processing including 1 surgical set with bioburden.
c. On 07/31/2024, 1 surgical case was performed, 4 surgical sets from Electrophysiology Lab were sent to Central Sterile for processing.
3. Interview with A7 (Manager of Electrophysiology Lab) on 08/19/2024 at approximately 2:50 p.m. confirmed that a surgical case was canceled due to surgical instrument contamination on 07/12/2024 and indicated they did not have any documentation of the quality improvement plan for cleaning and repairing of the surgical Electrophysiology Lab instruments.