HospitalInspections.org

Based on review of Centers for Medicare & Medicaid Services Ref: S & C: 14-44- letter Hospital/CAH/ASC letter dated August 29, 2014, review of Association of Perioperative Registered Nurses' (AORN) standards, hospital documents and interviews it was determined the facility failed to provide correctly, processed sterilized instruments to the surgical patient. Failure to perform proper sterilization of the instrumentation has the potential for an increased risk of infection causing harm to the surgical patient.

Findings include:

Review of Centers for Medicare & Medicaid Services Ref: S & C: 14-44- letter Hospital/CAH/ASC letter dated August 29, 2014, Professionally Accepted IUSS (Immediate Use Steam Sterilization) page 3 requires: "...Consistent with standards of practice previously articulated by national associations with expertise in infection prevention, the availability of IUSS is not considered an appropriate substitute for maintaining a sufficient inventory of instruments...."

AORN Guidelines For Perioperative Practice 2016 Edition Recommendation VII.a. page I.STRL8 requires: "...Immediate Use Sterilization should be used only when there is insufficient time to process by the preferred wrapped or container method intended for terminal sterilization. Immediate use steam sterilization should not be used as a substitute instrument inventory. [1: Strong Evidence]...."

Hospital protocols "Immediate-Use Steam Sterilization" page 3 requires: "...Instrument inventories should be sufficient to meet anticipated surgical volume and permit the time to complete all critical elements of reprocessing...."

Review of the Immediate Use Sterilization Record revealed six (6) rows across labeled as follows: Load #; Patient Sticker; Sterilizer Setting; biological Information, time in and time out.

The record revealed six (6) columns down as follows: integrator Y or N; Load contents; reason for flashing; exposure temp minimum; overall cycle time; and integrator pass/fail.

The Immediate Use Sterilization Records dated 07/27/16 revealed: eleven (11) patient stickers, (Patients #'s 26-36) with load contents of "eye instruments" ; sterilizer setting at gravity 10 minutes with 1 minute dry exposure time; reason for flashing "three (3) sets fourteen (14) cases" ; integrator Pass.

Immediate Use Sterilization Records dated 07/27/16 revealed: three (3) patient stickers, (Patients #'s 37-39) with load contents of "microscope knobs" ; sterilizer setting at gravity 10 minutes with 1 minute dry exposure time; reason for flashing: " brought in unsterile with Dr." : Integrator Pass.

The Director of Surgical Services confirmed during an interview conducted on 08/10/16, that the facility uses the same process for decontamination, terminal sterilization and Immediate -Use sterilization; except the Immediate -Use instruments do not go through the sonic cleaner. The Director confirmed both processes have about a 97% sterile rate.

The Central Service Lead Technician confirmed during an interview conducted on 08/09/16 that the facility is using Immediate Use Sterilization because the facility does not have enough instruments for the scheduled cases.