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101 DUDLEY STREET

PROVIDENCE, RI 02905

INFECTION CONTROL PROGRAM

Tag No.: A0749

Based on record review, and staff interview, it was determined that the hospital failed to monitor compliance with procedures, and protocols for infection control relative to reusable critical instruments for one of one Patient, ID #1.

Findings are as follows:

Review of the manufacturer's instruction titled "General Reprocessing Instructions for KARL STORZ Products...", under Cleaning Instructions for Instruments, states, in part:

"5. While the instruments are immersed, and using the appropriate cleaning brush, brush the surface of all instruments. In addition, brush the inside of all lumens [cavity or channel within a tube] with the appropriate size brush provided for your device.

8. After cleaning, inspect the instruments for cleanliness and damage."

Closed record review for Patient ID #1 revealed that on 1/3/2020, the Patient underwent a Hysteroscopy with myosure (a treatment for women who have heavy or irregular bleeding due to polyps or fibroids that have already been confirmed during a diagnostic hysteroscopy).

Review of the allegation revealed that, during the procedure, one of the instruments, a grasper that is fed through a scope, was noted to have black matter on the inside and at the end of the grasper.

During an interview with the Manager of Central Sterile Processing on 1/7/2020 at approximately 2:00 PM, she stated that during the procedure, both the circulating and surgical nurses noticed that, while they were viewing the procedure on the monitor in the procedure suite, observed there was debris on the end of the instrument grasper. The nurses immediately called out to the physician to stop the procedure and remove the scope from inside the patient.

The Manager further stated that during her investigation, it was determined that the technician that cleaned the equipment on the soiled side did not clean the lumen with the brush as required by the manufacturer.
Additionally, there was no uniform method in place for technicians on the clean side to inspect the instrument for cleanliness and damage.