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Based on review of the sterilization logs, observations and staff interview, the Hospital failed to consistently meet the standard of care and to adhere to the Hospital's Sterilization policies for validation of sterilized equipment.

As a result of the systems failure, three patients underwent surgical procedures with instruments that the Hospital was unable to validate as being sterilized.

Patients (Pts.) #1, #2 and #3 were consulted by the Infectious Disease Specialist for follow-up care. Pts. #1, #2 and #3 were prescribed a course of antibiotic therapy and Pt. #1 was returned to the Operating Room for debridement and exchange of the joint liner.


Please see tag A-0749

Based on review of the sterilization logs, observations and staff interview, the Hospital failed to consistently meet the standard of care and to adhere to the Hospital's Sterilization policies for validation of sterilized equipment.

The Surveyor toured the Sterile Processing Department (SPD) at 8:20 A.M. until 9:15 A.M. on 10/1/13. The Surveyor Interviewed the SPD Supervisor during the tour. The SPD Supervisor said a Bowie-Dick test (a test to detect air leaks) was run daily and a biological indicator (spore testing) was also run daily in the first autoclaved load of the day and each load that contained any implantable (devices designed to be left in the body) items. The SPD Supervisor said a chemical indicator (autoclave tape) was used on the external packaging and an internal indicator was placed inside the wrapped package that was being sterilized.

The SPD Policy titled " Quality Control Program for Sterilization Processes " indicated monitoring and documentation of the effectiveness of the sterilization process. SPD staff was required, by policy and standard, to verify time, temperature and pressure readings based on the sterilization system used.

SPD Policy titled " Sterilizer Monitoring Documents " indicated the sterilizer read out, documenting the time, temperature and pressure readings, was kept as part of the sterilization record. According to the policy, these read outs were to be reviewed daily.

The SPD Supervisor said the SPD Department was notified on 9/27/13, of an internal indicator, that was found by a surgical technician, to have failed the validation test for sterility. The SPD Supervisor said an immediate look-back at the sterilizer history of this autoclave load (Sterilizer #1, Load #4) indicated there was no evidence of a sterilizer read out, documenting the time, temperature and pressure readings as required by the Hospital policy.

Subsequently, three trays, of the ten (10) from Sterilizer #1, Load #4 were used for surgeries with Patients #1, #2, and #3.

The SPD Supervisor said the recall of Sterilizer #1, Load #4, yielded six (6) unused instrument sets, three (3) sets were used in surgery, and one (1) set was immediately reprocessed because of a tear in the wrap. The SPD Supervisor said the remaining six (6) unused instrument sets were viewed and all the chemical indicators (autoclave tapes) on the sets had changed color. The SPD Supervisor said the remaining six (6) instrument sets were opened and none of the internal indicators had passed the validation test for sterility.

The Surveyor toured the Operating Room (OR) at 9:20 A.M. until 9:50 A.M., on 10/1/13. The Surveyor interviewed the Director of Perioperative Services during the tour. The Director of Perioperative Services said she had interviewed all of the surgical technicians who were quite certain of their practice to validate the sterility of all equipment prior to use. The Director of Perioperative Services said it was part of the time out process to attest that the sterility criteria was met.

Review of the Time Out check off operating room case records for Pts. #1, #2 and #3, indicated that documentation confirmed that the sterility criteria was met as evidenced by an answer of yes for all entries.

The Sterilization Log ( list of surgical trays sterilized in the autoclave), for Sterilizer #1, Load #3, #4 and #5 was reviewed. Load #3, the sterilizer tape (record of sterilization) indicated the load was cycle #9489, Load #4 lacked a sterilizer tape, Load #5 sterilizer tape indicated the load was cycle #9490. By record of sterilization, Load #4 was never sterilized.

On 10/1/13, at 11:08 A.M., the Surveyor interviewed the Director of Infection Control. The Director of Infection Control said that when the Hospital could not be assured the instrument sets had been autoclaved, Pts. #1, #2 and #3 were consulted by the Infectious Disease Specialist for follow-up care. Pts. #1, #2 and #3 were prescribed a course of antibiotic therapy and Pt. #1 was returned to the Operating Room for debridement and exchange of the joint liner.