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OPERATING ROOM POLICIES

Tag No.: A0951

Based on observation, interview, and record review the facility failed to ensure that policies and procedures for flash sterilization are followed as evidenced by failure to consistently document and maintain a complete Sterilization Monitoring Log for surgical instruments that are flashed sterilized in 3 out of 3 flash sterilizers in the operating suite.
The findings include:
Observation of Ambulatory Surgical Services Department conducted on 03/05/2013 at 09:45 A.M. with the facility's Director of Surgical Services, Director of Quality Improvement and Director of Infection Control, revealed the facility has 3 flash sterilizers (#1, #2 and #3). Each of the flash sterilizers had a "Sterilization Monitoring Log". Observation of the 3 Autoclave Sterilization Monitoring Log books revealed that printouts from each use/run of the flash sterilizers was conducted on days the department was open which is mostly Monday through Friday. On the weekend, the department is open on an as needed basis only. Review of the log revealed the form states a place for the date, patient sticker, item description, cycle # (number), met y/n (yes or no), and a place for staff to document for each use. Record review of the "Sterilization Monitoring Logs" for flash sterilizers #1, #2 and #3 conducted on 03/05/2013 with the Director of Surgical Services showed documentation was inconsistent. The Director of Quality Improvement and Director of Infection Control were also present.
Review of the "Sterilization Monitoring Log" for flash sterilizer #1 for 01/16/2013 showed the flash sterilizer was used once but there was no "patient sticker" to track its use. On 01/22/2013, there were 3 cycles documented but the 2nd cycle did not have a "patient sticker" and the third cycle had incomplete documentation as to the date, the patient, the item description and the staff's initial).
Review of the "Sterilization Monitoring Log" for flash sterilizer #2 dated 12/26/2012 showed 3 cycles were done but documentation was incomplete (patient sticker, item description and staff's initial). On 01/10/2013, the flash sterilizer #2 was used once but documentation was incomplete (missing patient sticker). On 01/15/2013, there were 2 cycles documented but no indication of the patient (patient sticker missing) for both entries.
Review of the "Sterilization Monitoring Log" for flash sterilizer #3 dated 12/19/2012 showed it was used once but documentation was incomplete as to the date, patient sticker, item description, met y/n and staff's initial. On 12/21/2012, there was one documented entry but the documentation was incomplete (date, patient sticker, item description missing). On 12/28/2012, flash sterilizer #3 was used once but documentation was also incomplete as to the date, patient sticker, item description missing. Subsequent findings were also noted on 02/06/2013, 02/19/2013 and 02/26/2013. The missing data was evident for multiple days during the months of December 2012, January and February 2013.
Interview on 03/05/2013 at 10:29 A.M. with the Director of Surgical Services confirmed the above findings. She revealed that the policy of the facility is to document each entry/date, item description, patient identifier, cycle, test for each instrument(s) that is flashed sterilized in the facility.
Review of the facility policy and procedure titled, " Flash Sterilization " revealed, in the procedures section V (J) states "The RN [Registered Nurse] Circulator must initial each mechanical printout to signify verification of sterilization parameters and document items flashed on the printout". (K) Upon completion of the cycle, the mechanical printout will be completed to include load content, cycle and indicator strip verification". (L) Sterilizer printout documentation for each patient will be mounted on sheets and attached to sterilizing log sheet, as well as the patient name and information".
An interview with the Director of Surgical Services was conducted on 03/08/2013 at 11:50 A.M. During interview, the Director of Surgical Services informed the surveyor that corrective action has been initiated by facility by assigning the Assistant Nurse Manager to monitor and ensure that Surgical staff is completing the log. An inservice will be scheduled for all Surgical staff by "next week". The Director of Surgical Services added that she will also be monitoring the Surgical staff for 100% compliance.

OPERATING ROOM POLICIES

Tag No.: A0951

Based on observation, interview, and record review the facility failed to ensure that policies and procedures for flash sterilization are followed as evidenced by failure to consistently document and maintain a complete Sterilization Monitoring Log for surgical instruments that are flashed sterilized in 3 out of 3 flash sterilizers in the operating suite.
The findings include:
Observation of Ambulatory Surgical Services Department conducted on 03/05/2013 at 09:45 A.M. with the facility's Director of Surgical Services, Director of Quality Improvement and Director of Infection Control, revealed the facility has 3 flash sterilizers (#1, #2 and #3). Each of the flash sterilizers had a "Sterilization Monitoring Log". Observation of the 3 Autoclave Sterilization Monitoring Log books revealed that printouts from each use/run of the flash sterilizers was conducted on days the department was open which is mostly Monday through Friday. On the weekend, the department is open on an as needed basis only. Review of the log revealed the form states a place for the date, patient sticker, item description, cycle # (number), met y/n (yes or no), and a place for staff to document for each use. Record review of the "Sterilization Monitoring Logs" for flash sterilizers #1, #2 and #3 conducted on 03/05/2013 with the Director of Surgical Services showed documentation was inconsistent. The Director of Quality Improvement and Director of Infection Control were also present.
Review of the "Sterilization Monitoring Log" for flash sterilizer #1 for 01/16/2013 showed the flash sterilizer was used once but there was no "patient sticker" to track its use. On 01/22/2013, there were 3 cycles documented but the 2nd cycle did not have a "patient sticker" and the third cycle had incomplete documentation as to the date, the patient, the item description and the staff's initial).
Review of the "Sterilization Monitoring Log" for flash sterilizer #2 dated 12/26/2012 showed 3 cycles were done but documentation was incomplete (patient sticker, item description and staff's initial). On 01/10/2013, the flash sterilizer #2 was used once but documentation was incomplete (missing patient sticker). On 01/15/2013, there were 2 cycles documented but no indication of the patient (patient sticker missing) for both entries.
Review of the "Sterilization Monitoring Log" for flash sterilizer #3 dated 12/19/2012 showed it was used once but documentation was incomplete as to the date, patient sticker, item description, met y/n and staff's initial. On 12/21/2012, there was one documented entry but the documentation was incomplete (date, patient sticker, item description missing). On 12/28/2012, flash sterilizer #3 was used once but documentation was also incomplete as to the date, patient sticker, item description missing. Subsequent findings were also noted on 02/06/2013, 02/19/2013 and 02/26/2013. The missing data was evident for multiple days during the months of December 2012, January and February 2013.
Interview on 03/05/2013 at 10:29 A.M. with the Director of Surgical Services confirmed the above findings. She revealed that the policy of the facility is to document each entry/date, item description, patient identifier, cycle, test for each instrument(s) that is flashed sterilized in the facility.
Review of the facility policy and procedure titled, " Flash Sterilization " revealed, in the procedures section V (J) states "The RN [Registered Nurse] Circulator must initial each mechanical printout to signify verification of sterilization parameters and document items flashed on the printout". (K) Upon completion of the cycle, the mechanical printout will be completed to include load content, cycle and indicator strip verification". (L) Sterilizer printout documentation for each patient will be mounted on sheets and attached to sterilizing log sheet, as well as the patient name and information".
An interview with the Director of Surgical Services was conducted on 03/08/2013 at 11:50 A.M. During interview, the Director of Surgical Services informed the surveyor that corrective action has been initiated by facility by assigning the Assistant Nurse Manager to monitor and ensure that Surgical staff is completing the log. An inservice will be scheduled for all Surgical staff by "next week". The Director of Surgical Services added that she will also be monitoring the Surgical staff for 100% compliance.