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Based on document review and interview, it was determined that the Hospital failed to ensure that surgical instruments were properly cleaned and sterilized. This potentially places all patients scheduled for surgical procedures at risk for harm. As a result, the Condition of Participation, 42 CFR 482.42 Infection Control, was not in compliance.

Findings include:

1. The Hospital failed to ensure that surgical instruments were clean and properly sterilized. (A-0749).

An immediate jeopardy (IJ) began on 8/30/18, for the Hospital's failure to address improper cleaning and sterilization of surgical instruments, potentially placing all surgical patients at risk for serious harm.

An IJ was announced on 8/30/18 at 10:38 AM, during a meeting with the Chief Nursing Officer, President, Vice President, Accreditation Coordinator, Director of Quality, Medical Director of Surgery, Chief Medical Officer and the Chief Financial Officer. The Hospital failed to implement corrective measures. The immediate jeopardy was not removed by the survey exit date of 8/30/18.

Based on document review and interview, it was determined that for 4 of 4 adverse events related to sterilization and disinfection, the Hospital failed to ensure that surgical instruments were properly cleaned and sterilized. This has the potential to affect an average of 30 patients undergoing surgical procedures daily.

Findings include:

1. The Hospital's policy titled, "Sterile Processing Department [SPD] Decontamination Room: Procedure for Receiving and Handling of Reusable Instruments and Items" (last reviewed 7/10/18), was reviewed on 8/29/18 and required, "Cleaning of soiled instruments and supplies occurs as soon as possible... Thoroughly clean surfaces... After the cleaning procedures, instruments are sorted and inspected [for cleanliness and damage] in the instrument processing area..."

2. The Operating Room (OR) Incident Reports from 6/1/18 to 8/27/18 were reviewed on 8/28/18, and included four incidents related to sterilization as follows:

- An event dated 6/25/18 included, " ... reamers [tool for widening or finishing drilled holes] had bone chips, noticed after on field[,] hadn't touched anything else." The investigation report included, "Date Closed: 7/9/18... SPD referred [for follow-up]..." The report lacked documentation that the SPD investigated this incident. No actions were documented.

- An event dated 7/23/18 included, " ...Upon seeting [setting] up of the sterile field it was noted that there was bone stuck in a cannulated [hollow] drill bit that was sent up from sterile processing..." The investigation report included, "...The tray has been traced back to the employee[s] both washing [Manager of SPD/ E #6] the tray and wrapping [Reprocessing Technician / E#15] the tray and positive discipline is in motion..."

- An event dated 7/31/18 included, " ...Blood stain observed... inside the outer shell lid of the Hemorrhoid instrument pan opened..." The investigation report included, "...noted a 'splatter' like pattern of discoloration on the lids and once an effort to clean the 'splatter' off the lid proved fruitless it was then determined it could have been staining and or rust. [Reprocessing Technician/ E #14] instructed to report rust of these devices and pull said item from production..."

- An event dated 8/17/18 included, " ... Scrub Tech[nician] was setting up back table, before patient was in the room. Placed the obturator [tool used to obstruct a hole/tube] in sheath and black debris came out of the tip of the sheath..." The investigation report included, "...Positive discipline was given to the 2 [SPD Reprocessing Technicians] involved in the processing of this tray. One who washed [E #12] the tray, as well as the one who prep[ped] and packed [E #13]the tray for sterilization."

3. An interview was conducted with the Manager of Sterile Processing (E#6) and the Patient Safety Officer (E#7) on 8/29/18 at approximately 2:20 PM and again at 2:50 PM. E#6 stated that the instruments were supposed to be cleaned properly and the incidents have been handled on an individual basis with the staff involved (by means of counseling/positive discipline). All SPD staff (approximately 20) are trained upon hire to perform all tasks related to reprocessing including decontamination, inspection, packaging, and sterilization as they are required to rotate throughout the department. E#6 stated that competencies are only performed upon hire and no additional training is performed. E#7 stated that the 6/25/18 incident was missed and not fully investigated. E#7 also stated that five incidents of improper sterilization in a 3 month period is of concern and "We need to do more." No department-wide corrective actions have been taken to prevent further occurrences.