HospitalInspections.org

Based on a review of policy and procedures, sterilizer load cards/printouts, internal documentation, and staff interview it was determined that the Hospital failed to ensure all surgical instruments/items were sterilized prior to patient use. This breach in the sterilization process resulted in 19 possible patients exposed to the use of an unsterile instrument(s)/items and 3 confirmed patients exposed to the use of an unsterile surgical instruments. This has the potential to affect an average of 1,650 surgical cases each month.

The cumulative effect of the systemic practices within the sterilization process within Sterile Processing Department resulted in the hospital ' s inability to ensure that sterile surgical instruments/items were available for patient use.

Findings include:

An Immediate Jeopardy(IJ) to patient health and safety was identified at 2:40 PM on 3/6/12 with the Accreditation and Licensure Coordinators. The hospital failed to implement corrective measures to ensure another breach in the sterilization process did not occur for the potential use of unsterile items to be available for patient use.

The Hospital failed to ensure all sterilized items were sterilized by completing the required sterilization cycles. Please see deficiency cited at A 951A.

Failed to ensure that staff verified the sterilization process had been completed on items prior to patient use. Please see deficiency cited at A 951B.

The IJ was removed on 3/6/12 at 5:30 PM with the Hospital Chief Executive Officer, Chief Nursing Officer, Accredition and License Coordinators, Director of Quality and Safety, VP of Quality and Safety, and the Patient Safety Officer present. A written Hospital corrective action plan reviewed included the following: Change to chemical integrators that are easier to read and change color only with full sterilization; re-education for all Hospital clinical staff (anyone providing direct patient care, including physicians); update sterilizer and supervisor job descriptions to reflect verification of the sterilization process; create policy/process for report at end of each shift; created end of shift handoff form; tested the end of shift hand off form; education and supervision of the end of shift report form of all SPD personnel; phone to sterilization area rerouted to charge personnel; phone list updated and distributed to operating room staff; sterilizer employee job description updated to eliminate distracting tasks; disabled doorbell to SPD; timers placed at 5 steam sterilizers requiring pre-heat time; steam sterilizer load checklist updated to reflect use of pre-heat timers; SPD staff educated on use of timers (must receive education prior to being allowed to work); sterilizer employee no longer covers lunch for other SPD employees; sterilizer employee no longer responsible for taking operating room supplies outside of department; surgery support now responsible for obtaining sterile supplies from SPD; surgery personnel educated on change of obtaining sterile supplies from SPD; steam sterilizer checklist created; steam sterilizer load checklist updated to reflect validation of load number on sterilizer print outs; SPD staff educated on steam sterilizer checklist (signature required prior to being allowed to work); sterilizer employee job description changed to require verification of sterilizer print out; increase personnel by bringing on 2 temporary personnel; 4 positions posted internally, on the Hospital Website, and will advertise in local newspaper during next cycle.

A. Based on a review of policy and procedures, sterilizer load cards/printouts, and staff interview, it was determined that the Hospital failed to ensure 29 of 29 items had completed the sterilization process, this had the potential to effect 22 patients, identified by the Hospital, that had received surgical services.

Findings include:

1. The Hospital policy and procedure titled, "Steam Sterilizer, Terminal Sterilization Unit - Documentation Process", with a revised date of 10/07, was reviewed on 3/5/12. It indicated under "Supportive Data: Terminal sterilization is utilized to present sterile instrumentation for surgical procedures throughout the hospital and clinics....7. Record load number, sterilizer number and operator initials on sterilizer print-out. 8. Verify cycle parameters are correct. 9. Circle sterilization time, temperature, and cycle on sterilizer printout. 10. Staple load card, sterilization record, and load contents report together...."

2. The load checklist documentation, dated 2/23/12, for sterilizer number 8, load 7, was reviewed. It indicated on the sterilizer printout that the proper conditions for sterilization was achieved. However, The printout indicated this information was for load 6, not load 7 which was the load in the sterilizer. The steam chemical integrator for load 7 was reviewed and indicated that the load had not achieved proper conditions to ensure sterilization of the instruments in the load. The "Steam Load Record Card" for load 7 indicated "Processing conditions turn indicator line dark". There was no dark indicator line on the card indicating the conditions for sterilization were achieved. Attached load content documentation indicated that there were 29 packs in the load and many of the non-sterile instruments were sent out of the sterilization process department (SPD) to areas such as labor and delivery, pediatrics, and the surgical centers.

3. During interviews conducted on 3/5/12 at 10:30 AM, with the SPD manager and the Risk Manager, it was verbalized that on 2/23/12 an entire load of instruments and items failed to achieve the required conditions to ensure sterilization. The sterile processing technician failed to start the sterilization cycle. Numerous items were sent out to various departments throughout the Hospital. As of 3/6/12 all but two peel packs had been accounted for. It was also verbalized that based on the unit the non-sterile items were sent to, the type and number of procedures performed, the type of instruments, and the time the instruments were returned to the SPD, it was determined that some of the instruments had been used to provide surgical care to patients on 3 confirmed occasions and 19 other possible occasions.

4. During interviews with the Accreditation and Licensure Coordinators and SPD Manager, conducted on 3/5/12 at 3:45 PM, the above findings were confirmed.

B. Based on a review of policy and procedures, internal documentation, and staff interview, it was determined in 22 of 22 patients (3 confirmed exposures and 19 possible exposures to unsterile instruments) the Hospital failed to ensure only sterile instruments/items were used during surgery and procedures on patients.

Findings include:

1. The policy and procedure titled, "Sterile Package Recognition Procedure" with a revised date of 2/11, indicated under "IMPLEMENTATION: 2. Assess tape on wrapper package or chemical indicator on outside of instrument casket to ensure it has "turned" appropriate color. "Turned" tape indicates the item has been exposed to the conditions of sterilization...."

2. The internal documentation that is a list of patients that were potentially/confirmed exposure to non-sterile instruments was reviewed. It indicated a total of 19 patients that may have been exposed to non-sterile instruments/items and 3 that were confirmed as having been exposed. Hospital staff failed to verify the indicators/integrators in the individual packages had turned the proper color (that indicated the conditions for sterilization were achieved) prior to using the instrument/item on a patient.

3. During interviews with the Accreditation and Licensure Coordinators and SPD Manager, conducted on 3/5/12 at 11:30 AM, the above findings were confirmed.