HospitalInspections.org

Based on hospital policy and procedure review, infection control meeting minutes, hospital documentation review, manufacturers' recommendations, observations and staff interview, the Governing Body failed to have oversight of the process and monitoring of the sterilization of surgical instruments in the surgical suite; failed to ensure the hospital's infection control program provided oversight to ensure safety of the surgical instrument reprocessing and filed to ensure surgical services were provided within aceptable standards of practice.

The findings include:

1. The hospital staff failed to maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement (QAPI) program for monitoring the instrument sterilization processes in the surgical suite.

~Cross refer to 482.21 Condition of Participation: QAPI, Condition, Tag A0263
2. The hospital infection control program failed to have oversight of the instrument reprocessing processes to ensure surgical instruments were processed safely prior to use.

~Cross refer to 482.42 Condition of Participation: Infection Control, Condition, Tag A0747
3. The hospital failed to have an organized surgical services department that provided services within acceptable standards of practice.

~Cross refer to 482.51 Condition of Participation: Surgical Services, Condition, Tag A0940

Based on review of infection control meeting minutes, autoclave log reviews and staff interviews the hospital staff failed to maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement (QAPI) program for monitoring the instrument sterilization processes in the surgical suite.

The findings include:

The hospital staff failed to monitor and analyze the effectiveness and safety of instrument sterilization processes in the surgical suite.

~Cross refer to 482.21 (b) Quality Assessment Performance Improvement, Standard Tag A0273

Based on review of autoclave logs, infection control meeting minutes and staff interviews, the hospital staff failed to monitor and analyze the effectiveness and safety of instrument sterilization processes in the surgical suite.

The findings include:

Review of the surgical suite autoclave envelopes/logs for November 2015 revealed the logs were incomplete and failed to consistently have the documented load items, operating room number, time in and out of the autoclave, time, temperature and pressure of the load and chemical or biological indicator if used. Review of the envelopes/logs revealed printed autoclave strips were placed inside the envelope. Review revealed staff failed to document verification of the parameters of the load by failing to initial the strips. Review revealed some strips were illegible. Review revealed the number of loads recorded on the envelope/log failed to consistently match the number of strips in the envelope.

Review of Infection Prevention and Control Committee Meeting Minutes dated November 23, 2015 revealed "Discussion with Conclusions ... IPC (Infection Control staff member) had difficulty obtaining IUSS (Immediate Use Steam Sterilization) data since the last meeting and (CSR manager) agreed. IPC reviewed the past three months of CSR steam sterilization records with (CSR manager) and highlighted several opportunities with record keeping related to autoclaves in sub-sterile rooms (surgical suite) .... Recommendations/Actions Taken CSR: Continue to follow and report immediate use steam sterilization rates and corresponding monthly clinic and loaner tray reports. IPC would like a plan of action implemented immediately related to record keeping of loads ran in sub-sterile autoclaves. ... Resolution/Follow Up (CSR manager) will review the current record keeping process and report her actions taken at the next committee meeting in January 2016. ... "
Review of "Action Steps Taken for Record Keeping of Pre-Vac and IUSS" (not dated) revealed this was the response from the CSR manager to the request for an immediate plan of action requested during the November 23, 2015 meeting. Review revealed action items included "Process investigated. Gathered historical information and feedback. Informed instruments put through IUSS were documented by Circulating RN (registered nurse) in patient's record in Epic (electronic health record). Attempted to obtain report from Epic (electronic health record). No record available. Informed report would need to be built. Further investigation with Team Leader regarding record keeping. Asked for information to be reviewed monthly instead of past 3 months."
Interview on 12/02/2015 at 1545 with CSR staff #6 revealed CSR had an electronic bar scanning system that was implemented around a year ago in CSR to document the tracking of the instruments and trays through the sterilization processes. Interview revealed the eleven autoclaves in the surgical suite did not have the electronic bar coding system available and staff had to use the manual hand written envelopes/logs to document and verify sterilization parameters were met (time, temperature, dry time and completion of cycle).

Interview on 12/03/2015 at 1430 with CSR staff #6 revealed she was responsible for verifying the controls were completed (biological, Bowie Dick, leak tests) on the autoclaves in the CSR area and four autoclaves in the surgical suite (autoclave #13, 15-17, 18-19 and 9). The staff member stated she counted the number of controls that were done of these identified autoclaves monthly and gave that information to her prior manager. Interview revealed the CSR staff member did not check for leak testing on all autoclaves in the surgical suite because she had been told to only check the identified autoclaves. Interview revealed the staff member did not look at the strips or envelope logs to verify that the correct sterilizer parameters were used during the sterilization process for Immediate Use Sterilization.

Interview on 12/02/2015 at 1040 with OR-AS #2 revealed the volume of surgeries had increased by around 10% (500 surgeries) over the past year. Interview revealed the staff member knew that there was a need to purchase additional instruments and that she had a difficult time determining what instruments were needed based on lack of documentation on the IUSS envelopes/logs. Interview revealed the logs did not contain adequate information to allow her to determine when IUSS (flash) sterilization was occurring versus a longer cycle use, making it difficult to determine the need for purchase of additional instruments. Interview on 12/04/2015 at 1500 with OR-AS #2 confirmed after review of sample of "Steam Flash Sterilization Record Keeping Envelopes" and Autoclave printout documentation, there was no documentation of validation of sterilization parameters with the use of immediate use sterilizers in the operating room.

Interview on 12/02/2015 at 1520 with CSR-AS #4 revealed she had just started at the hospital in October 2015. Interview revealed the staff member and ICP #3 had discovered some issues with documentation of the IUSS (Immediate Use Steam Sterilization) in November 2015. The staff member stated a review of three months of the surgical suite autoclave logs was done and it was determined that staff were not documenting appropriately. Interview revealed there was an awareness that additional instruments were needed as well as additional space for the instruments.

Interview on 12/02/2015 at 1605 with ICP #3 revealed the staff member was preparing for the November meeting and had historically been provided data for the volume of IUSS monthly use from the prior CSR manager. Interview revealed he went to collect the number from the surgical suite autoclave envelopes/logs and found that he was unable to determine by the documentation the volume of IUSS. ICP #3 stated he and CSR-AS #4 reviewed 3 months of surgical suite autoclave envelopes and discovered that staff were not capturing the appropriate information on the logs. Interview revealed opportunities were identified and it was discussed at the November 23, 2015 infection control meeting. Interview confirmed surgical procedures had been performed after the deficiencies were discovered and no corrective actions or increased monitoring had been implemented after the findings.

Based on hospital policy and procedure review, review of Infection Control Committee Meeting minutes, hospital documentation review, manufacturers' recommendations, observations and staff interview, the hospital infection control program failed to have oversight of the instrument reprocessing processes to ensure surgical instruments were processed safely prior to use.

The findings include:

The hospital's infection control program failed to monitor and provide oversight of the sterilization process to ensure validation of sterilization parameters were met with the use of Immediate Use Sterilizers in the surgical suite; failed to ensure leak testing of the autoclaves in the surgical suite was done weekly according to manufacturer's recommendations for 6 of 9 autoclaves requiring leak testing (autoclave #10, 9, 6-8, 11-12, 14-15 and 5-7); and failed to ensure storage of sterilized trays and instruments in designated areas to prevent availability and use of contaminated instruments.

~Cross refer to 482.42(a)(1), Infection Control, Standard Tag A0749

Based on hospital policy and procedure review, observations, hospital documentation review, review of Infection Control Committee Meeting minutes, manufacturers' recommendations and staff interview, the hospital's infection control program failed to monitor and provide oversight of the sterilization process to ensure validation of sterilization parameters were met with the use of Immediate Use Sterilizers in the surgical suite; failed to ensure leak testing of the autoclaves in the surgical suite was done weekly according to manufacturer's recommendations for 6 of 9 autoclaves requiring leak testing (autoclave #10, 9, 6-8, 11-12, 14-15 and 5-7); and failed to ensure storage of sterilized trays and instruments in designated areas to prevent availability and use of contaminated instruments.

The findings include:

1. Review of "SURGICAL SERVICES POLICY STATEMENT.. CENTRAL STERILE REPROCESSING....POLICY NAME: Immediate Use Sterilizer, Operations and daily monitoring of EFFECTIVE DATE: 2/90 REVIEW/REVISION HISTORY: 12/12..... POLICY: The Immediate Use Sterilizers will be operated per the manufacturer's instructions. If there is a time when there is more than one manufacturer's recommended operation instruction, the most strict (higher standard) will be followed. Operation of the Immediate Use Sterilizer.... 5. At the beginning of the paper printout, there is a space for the operators initials to validate the cycle time chosen, write your initials in this space. The sterilizer automatically processes through the cycle as shown.....10. The sterilization process parameters must be validated. a. sterilization time is 4 or 10 minutes. b. dry time is 0 minutes as the sterilizer still draws a slight vacuum c. sterilization temperature is 270 degrees..12. If all parameters are met: a initial the envelope."

Observation during tour of the operating room suite on 12/02/2015 at 1115 revealed a total of 11 steam sterilizers (autoclaves) located within the surgical suite. Observation revealed each of the steam sterilizers had "Steam Flash Sterilization" record keeping envelopes located in the rooms with each of the sterilizers. Interview with ICP #3 (Infection Control administrative staff member) and OR AS #2 (surgical services administrative staff member) during the tour revealed each load processed in the sterilizer was recorded and logged on the envelope.

Hospital documentation review on 12/04/2015 at 0900 of Autoclave identified as "3-4" revealed 19 (days in use) "Steam Flash Sterilization Record Keeping Envelopes" for November 2015. Review of the envelope dated 11/02/2015 revealed one load run. Review of the strips revealed a total of 6 loads run. Review revealed the first load was run as controls by central sterile reprocessing staff. Review of the strips revealed five (5) loads (cycles) of surgical instruments processed as "flash" (immediate use sterilization) at 0913,0929, 1241,1342 and 1428. Review revealed no initials on the strips validating the time, temperature, dry time and completion of the cycle. Review of the envelope dated 11/19/2015 revealed one load run. Review of the strips revealed a total three load run. Review revealed the first load was run as controls by central sterile reprocessing staff. Review of the strips revealed two (2) loads (cycles) of surgical instruments processed as "flash" (immediate use sterilization) at 1344 and 1354. Review revealed no initials on the strips validating the time, temperature, dry time and completion of the cycle. Review of the envelope dated 11/24/2015 revealed on load run.. Review of the strips revealed a total three load run. Review revealed the first load was run as controls by central sterile reprocessing staff. Review of the strips revealed two (2) loads (cycles) of surgical instruments processed as "flash" (immediate use sterilization) at 1130 and 1326. Review revealed no initials on the strips validating the time, temperature, dry time and completion of the cycle. Review of the envelope dated 11/30/2015 revealed one load run. Review of the strips revealed a total three load run. Review revealed the first load was run as controls by central sterile reprocessing staff. Review of the strips revealed two (2) loads (cycles) of surgical instruments processed as "flash" (immediate use sterilization) at 0712 and 1015. Review revealed no initials on the strips validating the time, temperature, dry time and completion of the cycle. Documentation review revealed a total of thirteen (13) immediate use sterilization cycles not validated for time, temperature and dry time according to policy for autoclave identified as "3-4" for November 2015.

Hospital documentation review on 12/04/2015 at 0930 of Autoclave identified as "5-7" revealed 28 (days in use) "Steam Flash Sterilization Record Keeping Envelopes" for November 2015. Review of the envelope dated 11/02/2015 revealed four loads run. Review of the strips revealed a total eight load run. Review revealed three loads was run as controls and one "prevac" by central sterile reprocessing staff. Review of the strips revealed four (4) loads (cycles) of surgical instruments processed as "flash" (immediate use sterilization) at 1303, 1350, 1515 and 1847. Review revealed no initials on the strips validating the time, temperature, dry time and completion of the cycle. Review of the envelope dated 11/03/2015 revealed four loads run. Review of the strips revealed a total eight loads run. Review revealed three loads were run as controls and one "prevac" by central sterile reprocessing staff. Review of the strips revealed four (4) loads (cycles) of surgical instruments processed as "flash" (immediate use sterilization) at 0719, 0737, 0911 and 1218. Review revealed no initials on the strips validating the time, temperature, dry time and completion of the cycle. Review of the envelope dated 11/04/2015 revealed four loads run. Review of the strips revealed a total five loads run. Review revealed three loads was run as controls by central sterile reprocessing staff. Review of the strips revealed two (2) loads (cycles) of surgical instruments processed as "flash" (immediate use sterilization) at 0949 and 1528. Review revealed no initials on the strips validating the time, temperature, dry time and completion of the cycle. Review of the envelope dated 11/07/2015 revealed three loads run. Review of the strips revealed a total four loads run. Review revealed three loads was run as controls by central sterile reprocessing staff. Review of the strips revealed one (1) load (cycle) of surgical instruments processed as "flash" (immediate use sterilization) at 1057. Review revealed no initials on the strips validating the time, temperature, dry time and completion of the cycle. Review of the envelope dated 11/09/2015 revealed three loads run. Review of the strips revealed a total four loads run. Review revealed three loads was run as controls by central sterile reprocessing staff. Review of the strips revealed one (1) load (cycle) of surgical instruments processed as "flash" (immediate use sterilization) at 0723. Review revealed no initials on the strips validating the time, temperature, dry time and completion of the cycle. Review of the envelope dated 11/11/2015 revealed three loads run. Review of the strips revealed a total five loads run. Review revealed three loads was run as controls by central sterile reprocessing staff. Review of the strips revealed two (2) loads (cycles) of surgical instruments processed as "flash" (immediate use sterilization) at 1035 and 1035. Review revealed no initials on the strips validating the time, temperature, dry time and completion of the cycle. Review of the envelope dated 11/16/2015 revealed five loads run. Review of the strips revealed a total five loads run. Review revealed three loads was run as controls by central sterile reprocessing staff. Review of the strips revealed two (2) loads (cycles) of surgical instruments processed as "flash" (immediate use sterilization) at 0737 and 0757. Review revealed no initials on the strips validating the time, temperature, dry time and completion of the cycle. Review of the envelope dated 11/18/2015 revealed seven loads run. Review of the strips revealed a total seven loads run. Review revealed three loads was run as controls by central sterile reprocessing staff. "Load #4" parameters on printout are illegible unable to determine type of load run. Review of the strips revealed three (3) loads (cycles) of surgical instruments processed as "flash" (immediate use sterilization) at 1232, 1353 and 1604 revealed no initials on the strips validating the time, temperature, dry time and completion of the cycle. Review of the envelope dated 11/20/2015 revealed three loads run. Review of the strips revealed three "flash" cycles that were legible, portions of the strip were illegible and unable to determine the total loads. Review of the strips revealed three (3) loads (cycles) of surgical instruments processed as "flash" (immediate use sterilization) at 0926, 0947, and 1319. Review revealed no initials on the strips validating the time, temperature, dry time and completion of the cycle. Review of the envelope dated 11/22/2015 revealed three loads run. Review of the strips revealed that no cycles/ loads were legible. Unable to determine how many or type of cycles run on the autoclave. Review of the envelope dated 11/24/2015 revealed five loads run. Review of the strips revealed a total eight loads run. Review revealed three loads was run as controls and two as "prevac" by central sterile reprocessing staff. Review of the strips revealed three (3) loads (cycles) of surgical instruments processed as "flash" (immediate use sterilization) at 1236, 1449 and 1502. Review revealed no initials on the strips validating the time, temperature, dry time and completion of the cycle. Review of the envelope dated 11/27/2015 revealed three loads run. Review of the strips revealed a total five loads run. Review revealed three loads was run as controls by central sterile reprocessing staff. Review of the strips revealed two (2) loads (cycles) of surgical instruments processed as "flash" (immediate use sterilization) at 0651 and 1246. Review revealed no initials on the strips validating the time, temperature, dry time and completion of the cycle. Documentation review revealed a total of twenty-seven (27) immediate use sterilization cycles not validated for time, temperature and dry time according to policy for autoclave identified as "5-7" for November 2015.



16369

Hospital documentation review on 12/04/2015 at 0900 of Autoclave identified as "10" revealed 19 "Steam Flash Sterilization Record Keeping Envelopes" for November 2015. Review of the envelope dated 11/03/2015 revealed a total of 4 loads run. Review of the strips revealed a total of 6 loads run. Review revealed the first three loads were run as controls by central sterile reprocessing staff. Review of the strips revealed two (2) loads (cycles) of surgical instruments processed as "flash" (immediate use sterilization) at 1142 and 1331. Review revealed no initials on the strips validating the time, temperature, dry time and completion of the cycle. Review of the envelope dated 11/04/2015 revealed a total of 3 loads run. Review of the strips revealed a total of 4 loads run. Review revealed the first three loads were run as controls by central sterile reprocessing staff. Review of the strips revealed one (1) load (cycle) of surgical instruments processed as "flash" at 1315. Review revealed no initials on the strip validating the time, temperature, dry time and completion of the cycle. Review of the envelope dated 11/05/2015 revealed a total of 3 loads run. Review of the strips revealed a total of 4 loads run. Review revealed the first three loads were run as controls by central sterile reprocessing staff. Review of the strips revealed one (1) load (cycle) of surgical instruments processed as "flash" at 1527. Review revealed no initials on the strip validating the time, temperature, dry time and completion of the cycle. Review of the envelope dated 11/18/2015 revealed a total of 4 loads run. Review of the strips revealed a total of 4 loads run. Review revealed the first three loads were run as controls by central sterile reprocessing staff. Review of the strips revealed one (1) load (cycle) of surgical instruments processed as "flash" at 1416. Review revealed no initials on the strip validating the time, temperature, dry time and completion of the cycle. Review of the envelope dated 11/23/2015 revealed a total of 3 loads run. Review of the strips revealed a total of 4 loads run. Review revealed the first three loads were run as controls by central sterile reprocessing staff. Review of the strips revealed one (1) load (cycle) of surgical instruments processed as "flash" at 1451. Review revealed no initials on the strip validating the time, temperature, dry time and completion of the cycle. Review of the envelope dated 11/24/2015 revealed a total of 4 loads run. Review of the strips revealed a total of 5 loads run. Review revealed the first three loads were run as controls by central sterile reprocessing staff. Review of the strips revealed two (2) loads (cycles) of surgical instruments processed as "flash" at 0935 and 1623. Review revealed no initials on the strip validating the time, temperature, dry time and completion of the cycle. Review of the envelope dated 11/25/2015 revealed a total of 4 loads run. Review of the strips revealed a total of 5 loads run. Review revealed the first three loads were run as controls by central sterile reprocessing staff. Review of the strips revealed two (2) loads (cycles) of surgical instruments processed as "flash" at 0812 and 1244. Review revealed no initials on the strip validating the time, temperature, dry time and completion of the cycle. Review of the envelope dated 11/30/2015 revealed a total of 4 loads run. Review of the strips revealed a total of 5 loads run. Review revealed the first three loads were run as controls by central sterile reprocessing staff. Review of the strips revealed two (2) loads (cycles) of surgical instruments processed as "flash" at 1756 and 1837. Review revealed no initials on the strip validating the time, temperature, dry time and completion of the cycle. Documentation review revealed a total of twelve (12) immediate use sterilization cycles not validated for time, temperature and dry time according to policy for autoclave identified as "10" for November 2015.

Review of the "Steam Flash Sterilization Record Keeping Envelopes" for November 2015 on 12/04/2015 at 0900 of Autoclave identified as "1-2" revealed a total of 18 envelopes (days the autoclave was used). Review of the envelope dated 11/02/2015 revealed a total of 1 load run. Review of the strips revealed a total of 3 loads run. Review revealed the first load was run as a control by central sterile reprocessing staff. Review of the strips revealed two (2) loads (cycles) of surgical instruments processed as "flash" (immediate use sterilization) at 1050 and 1231. Review revealed no initials on the strips validating the time, temperature, dry time and completion of the cycle. Review of the envelope dated 11/03/2015 revealed a total of 1 load run. Review of the strips revealed a total of 2 loads run. Review revealed the first load was run as a control by central sterile reprocessing staff. Review of the strips revealed one (1) load (cycle) of surgical instruments processed as "flash" at 1114. Review revealed no initials on the strips validating the time, temperature, dry time and completion of the cycle. Review of the envelope dated 11/09/2015 revealed a total of 1 load run. Review of the strips revealed a total of 2 loads run. Review revealed the first load was run as a control by central sterile reprocessing staff. Review of the strips revealed one (1) load (cycle) that was illegible with no initials on the strip validating the time, temperature, dry time and completion of the cycle. Review of the envelope dated 11/12/2015 revealed a total of 1 load run. Review of the strips revealed a total of 2 loads run. Review revealed the first load was run as a control by central sterile reprocessing staff. Review of the strips revealed one (1) load (cycle) of surgical instruments processed as "flash" at 1235. Review revealed no initials on the strips validating the time, temperature, dry time and completion of the cycle. Review of the envelope dated 11/18/2015 revealed a total of 1 load run. Review of the strips revealed a total of 2 loads run. Review revealed the first load was run as a control by central sterile reprocessing staff. Review of the strips revealed one (1) load (cycle) of surgical instruments processed as "flash" at 1425. Review revealed no initials on the strips validating the time, temperature, dry time and completion of the cycle. Review of the envelope dated 11/19/2015 revealed a total of 1 load run. Review of the strips revealed a total of 2 loads run. Review revealed the first load was run as a control by central sterile reprocessing staff. Review of the strips revealed one (1) load (cycle) of surgical instruments processed as "flash" at 1326. Review revealed no initials on the strips validating the time, temperature, dry time and completion of the cycle. Review of the envelope dated 11/23/2015 revealed a total of 1 load run. Review of the strips revealed a total of 2 loads run. Review revealed the first load was run as a control by central sterile reprocessing staff. Review of the strips revealed one (1) load (cycle) of surgical instruments processed as "flash" at 0938. Review revealed no initials on the strips validating the time, temperature, dry time and completion of the cycle. Documentation review revealed a total of eight (8) immediate use sterilization cycles not validated for time, temperature and dry time according to policy for autoclave identified as "10" for November 2015.

Interview on 12/03/2015 at 1630 with OR Nurse #1 confirmed nurses are not consistent with their documentation on the log (envelope) and some do not document on the log at all and only in Epic (electronic medical record). Interview revealed "Personally, I only document in Epic since it went live. We were told we didn't have to document on the log anymore" Interview revealed Epic went live in March 2014.

Interview on 12/04/2015 at 1500 with OR-AS #2 confirmed after review of sample of "Steam Flash Sterilization Record Keeping Envelopes" and Autoclave printout documentation there was no validation of the sterilization time, temperature and dry time with the use of immediate use sterilizers in the operating room prior to the instruments placed into use. Interview revealed staff were told to stop documenting on the log by the prior operating room director when they went live with Epic. Interview revealed this practice is not consistent with policy or standard practice.

Review of Infection Prevention and Control Committee Meeting Minutes dated November 23, 2015 revealed "Discussion with Conclusions ... IPC (Infection Control staff member) had difficulty obtaining IUSS (Immediate Use Steam Sterilization) data since the last meeting and (CSR manager) agreed. IPC reviewed the past three months of CSR steam sterilization records with (CSR manager) and highlighted several opportunities with record keeping related to autoclaves in sub-sterile rooms (surgical suite) .... Recommendations/Actions Taken CSR: Continue to follow and report immediate use steam sterilization rates and corresponding monthly clinic and loaner tray reports. IPC would like a plan of action implemented immediately related to record keeping of loads ran in sub-sterile autoclaves. ... Resolution/Follow Up (CSR manager) will review the current record keeping process and report her actions taken at the next committee meeting in January 2016. ... "
Interview on 12/02/2015 at 1605 with ICP #3 revealed the staff member was preparing for the November meeting and had historically been provided data for the volume of IUSS monthly use from the prior CSR manager. Interview revealed he went to collect the number from the surgical suite autoclave envelopes/logs and found that he was unable to determine by the documentation the volume of IUSS. ICP #3 stated he and CSR-AS #4 reviewed 3 months of surgical suite autoclave envelopes and discovered that staff were not capturing the appropriate information on the logs. Interview revealed opportunities were identified and it was discussed at the November 23, 2015 infection control meeting. Interview confirmed surgical procedures had been performed after the deficiencies were discovered and no corrective actions or increased monitoring had been implemented after the findings.
2. Review of "SURGICAL SERVICES POLICY STATEMENT.. CENTRAL STERILE REPROCESSING....POLICY NAME: Pre-Vacuum Steam Sterilizers (#9, 10, 20, 30 and 13) Operations and daily monitoring of EFFECTIVE DATE: 2/90 REVIEW/REVISION HISTORY: 12/12..... POLICY: Pre-Vacuum Steam Sterilizers (#10, 20 and 13) will be operated per the manufacturer's instructions. If there is a time when there is more than one manufacturer's recommended operation instruction, the most strict (higher standard) will be followed. Monitoring of the Prevacuum Sterilizer 1. Leak Test Monitoring.... will be done once a week on all prevacuum sterilizers."

Review of manufacturer's recommendations for the types of steam sterilizers used in the operating room revealed leak testing is recommended to be done weekly for 9 of the 11 autoclaves (not required on autoclave #1-2 and #3-4 due to only used for IUSS).

Observation and interview with ICP #3 and OR-AS #2 during tour on 12/04/2015 at 1630 revealed Autoclave 10 was a prevacuum sterilizer. Review of the "Steam Flash Sterilization Record Keeping Envelopes" for November 2015 for Autoclave 10 revealed the autoclave was used 19 days from 11/02/2015 through 11/30/2015. Review of the envelopes revealed no leak testing was done on Autoclave 10 in November 2015.

Observation and interview with ICP #3 and OR-AS #2 during tour on 12/04/2015 at 1630 revealed Autoclave 9 was a prevacuum sterilizer. Review of the "Steam Flash Sterilization Record Keeping Envelopes" for November 2015 for Autoclave 9 revealed the autoclave was used 21 days from 11/02/2015 through 11/30/2015. Review of the envelopes revealed leak testing was done on 11/02/2015, 11/16/2015 (14 days since prior leak testing) and 11/23/2015. Review revealed weekly leak testing was not done according to policy between 11/02/2015 and 11/16/2015.

Observation and interview with ICP #3 and OR-AS #2 during tour on 12/04/2015 at 1630 revealed Autoclave 6-8 was a prevacuum sterilizer. Review of the "Steam Flash Sterilization Record Keeping Envelopes" for November 2015 for Autoclave 6-8 revealed the autoclave was used 28 days from 11/01/2015 through 11/30/2015. Review revealed no leak testing was done on Autoclave 6-8 in November 2015.

Observation and interview with ICP #3 and OR-AS #2 during tour on 12/04/2015 at 1630 revealed Autoclave 11-12 was a prevacuum sterilizer. Review of the "Steam Flash Sterilization Record Keeping Envelopes" for November 2015 for Autoclave 11-12 revealed the autoclave was used 27 days from 11/02/2015 through 11/30/2015. Review revealed no leak testing was done on Autoclave 11-12 in November 2015.

Observation and interview with ICP #3 and OR-AS #2 during tour on 12/04/2015 at 1630 revealed Autoclave 14-16 was a prevacuum sterilizer. Review of the "Steam Flash Sterilization Record Keeping Envelopes" for November 2015 for Autoclave 14-16 revealed the autoclave was used 19 days from 11/02/2015 through 11/30/2015. Review revealed no leak testing was done on Autoclave 11-12 in November 2015.

Observation and interview with ICP #3 and OR-AS #2 during tour on 12/04/2015 at 1630 revealed Autoclave 5-7 was a prevacuum sterilizer. Review of the "Steam Flash Sterilization Record Keeping Envelopes" for November 2015 for Autoclave 5-7 revealed the autoclave was used from 11/01/2015 through 11/30/2015. Review revealed no leak testing was done on Autoclave 5-7 in November 2015.

3. Review of "SURGICAL SERVICES POLICY STATEMENT.. CENTRAL STERILE REPROCESSING....POLICY NAME: Vendor (Loaner) Trays EFFECTIVE DATE: 03/2012 no noted review or revision history... POLICY: All Loaner instruments, instruments not owned by the facility, must be received, inspected, recorded, decontaminated and sterilized in there Sterile Processing department according to the manufacturer's instructions. All items are considered "non-sterile" anytime instrumentation is provided as a loaner from any company and/or its representative... Central Sterile Reprocessing Department (CSR) ...5. Item(s)/tray(s) must be decontaminated after use and returned to the loaner room as clean. 11. Once cleaned, the loaner sets shall be transported to a holding area for pick up by the vendor representative. These trays should be picked up with in two (2) business days post- procedure."

Observation during tour of the "Vendor Room" with ICP #3 and CSR-AS #4 central sterile reprocessing administrative staff members (CSR staff # on 12/03/2015 at 1115 revealed a storage area located in the basement of the hospital that was unsecured. Observation revealed vendor shelving separated areas for each vendor. Observation revealed four sterilized vendor spinal trays located on a shelf. Observation revealed the sterilized trays were identified as "MARS 3V, date of surgery 12-2 2:30"; "MARS 3V Back Up, date of surgery 12-2 2:45"; Angled LDP Back Up, date of surgery 12-2 2:45"; and "Lnr (Vendor name) Instrument Tray" with a bar code scan and date of 12/2/15. Further review of the vendor trays revealed the trays had external sterilizer tape indicating the trays were sterile and ready for use. Further observation revealed three peel packs containing instruments that were sterilized and ready for use. Observation revealed another vendor shelf that contained 19 peel packs containing surgical instruments that had been sterilized and were ready for use.

Interview on 12/03/2015 at 1115 during the tour of the vendor room with ICP #3 and CSR-AS #4 revealed the four spine trays appeared to be sterilized and ready for use. The staff members stated the packs should go back to central sterile reprocessing (CSR) to be decontaminated and re-sterilized because the trays are considered dirty once they leave the CSR and surgical suite areas. The CSR-AS #4 staff member stated "These are sterilized. They should not be down here. They are available for use." The staff members revealed that if these trays were taken to the operating room, they would appear to be okay for use. Interview revealed there was no way to tell that the trays were stored in the vendor room and should not be used. Interview revealed that the surgical instruments in peel packs were sterilized and ready for use. Interview revealed these items should not be stored in the vendor room as sterilized items. Interview revealed the instruments in peel packs should be returned to CSR for reprocessing. Interview revealed no sterilized instruments or trays should be stored in the vendor room.

Interview on 12/03/2015 at 1520 with Vendor #5 revealed the vendor representative worked with spine surgeons and was in the operating room daily for the past two years. Interview revealed Vendor #5 had trays that were "coming into the hospital today. They will go to the basement vendor room." Interview revealed the trays would come to the hospital clean and then go to the decontamination room in CSR to be washed and sterilized. Interview revealed the vendor had three carts for storing vendor trays and there was specified space in the instrument storage area for vendor trays. Interview with the vendor revealed that sterile trays should not be stored in the vendor room.

Based on hospital policy and procedure review, hospital documentation review, manufacturers' recommendations, observations and staff interview, the hospital failed to have an organized surgical services department that provided services within acceptable standards of practice.

The findings include:

The hospital's operating room staff failed to validate sterilization parameters per hospital policy while performing immediate use steam sterilization with autoclaves in the surgical suite; failed to ensure leak testing of the autoclaves in the surgical suite was done weekly according to manufacturer's recommendations for 6 of 9 autoclaves requiring leak tesing (autoclave #10, 9, 6-8, 11-12, 14-15 and 5-7); and failed to ensure storage of sterilized trays and instruments in designated areas to prevent availability and use of contaminated instruments.

~Cross refer to 482.51(b) Operating Room Policies - Standard: Tag A0951.

Based on hospital policy and procedure review, observations, hospital documentation review, manufacturers' recommendations and staff interview, the hospital's operating room staff failed to validate sterilization parameters per hospital policy while performing immediate use steam sterilization with autoclaves in the surgical suite; failed to ensure leak testing of the autoclaves in the surgical suite was done weekly according to manufacturer's recommendations for 6 of 9 autoclaves requiring leak testing (autoclave #10, 9, 6-8, 11-12, 14-15 and 5-7); and failed to ensure storage of sterilized trays and instruments in designated areas to prevent availability and use of contaminated instruments.

The findings include:

1. Review of "SURGICAL SERVICES POLICY STATEMENT.. CENTRAL STERILE REPROCESSING....POLICY NAME: Immediate Use Sterilizer, Operations and daily monitoring of EFFECTIVE DATE: 2/90 REVIEW/REVISION HISTORY: 12/12..... POLICY: The Immediate Use Sterilizers will be operated per the manufacturer's instructions. If there is a time when there is more than one manufacturer's recommended operation instruction, the most strict (higher standard) will be followed. Operation of the Immediate Use Sterilizer.... 5. At the beginning of the paper printout, there is a space for the operators initials to validate the cycle time chosen, write your initials in this space. The sterilizer automatically processes through the cycle as shown.....10. The sterilization process parameters must be validated. a. sterilization time is 4 or 10 minutes. b. dry time is 0 minutes as the sterilizer still draws a slight vacuum c. sterilization temperature is 270 degrees..12. If all parameters are met: a initial the envelope."

Observation during tour of the operating room suite on 12/02/2015 at 1115 revealed a total of 11 steam sterilizers (autoclaves) located within the surgical suite. Observation revealed each of the steam sterilizers had "Steam Flash Sterilization" record keeping envelopes located in the rooms with each of the sterilizers. Interview with ICP #3 (Infection Control administrative staff member) and OR AS #2 (surgical services administrative staff member) during the tour revealed each load processed in the sterilizer was recorded and logged on the envelope.

Hospital documentation review on 12/04/2015 at 0900 of Autoclave identified as "3-4" revealed 19 (days in use) "Steam Flash Sterilization Record Keeping Envelopes" for November 2015. Review of the envelope dated 11/02/2015 revealed one load run. Review of the strips revealed a total of 6 loads run. Review revealed the first load was run as controls by central sterile reprocessing staff. Review of the strips revealed five (5) loads (cycles) of surgical instruments processed as "flash" (immediate use sterilization) at 0913,0929, 1241,1342 and 1428. Review revealed no initials on the strips validating the time, temperature, dry time and completion of the cycle. Review of the envelope dated 11/19/2015 revealed one load run. Review of the strips revealed a total three load run. Review revealed the first load was run as controls by central sterile reprocessing staff. Review of the strips revealed two (2) loads (cycles) of surgical instruments processed as "flash" (immediate use sterilization) at 1344 and 1354. Review revealed no initials on the strips validating the time, temperature, dry time and completion of the cycle. Review of the envelope dated 11/24/2015 revealed on load run.. Review of the strips revealed a total three load run. Review revealed the first load was run as controls by central sterile reprocessing staff. Review of the strips revealed two (2) loads (cycles) of surgical instruments processed as "flash" (immediate use sterilization) at 1130 and 1326. Review revealed no initials on the strips validating the time, temperature, dry time and completion of the cycle. Review of the envelope dated 11/30/2015 revealed one load run. Review of the strips revealed a total three load run. Review revealed the first load was run as controls by central sterile reprocessing staff. Review of the strips revealed two (2) loads (cycles) of surgical instruments processed as "flash" (immediate use sterilization) at 0712 and 1015. Review revealed no initials on the strips validating the time, temperature, dry time and completion of the cycle. Documentation review revealed a total of thirteen (13) immediate use sterilization cycles not validated for time, temperature and dry time according to policy for autoclave identified as "3-4" for November 2015.

Hospital documentation review on 12/04/2015 at 0930 of Autoclave identified as "5-7" revealed 28 (days in use) "Steam Flash Sterilization Record Keeping Envelopes" for November 2015. Review of the envelope dated 11/02/2015 revealed four loads run. Review of the strips revealed a total eight load run. Review revealed three loads was run as controls and one "prevac" by central sterile reprocessing staff. Review of the strips revealed four (4) loads (cycles) of surgical instruments processed as "flash" (immediate use sterilization) at 1303, 1350, 1515 and 1847. Review revealed no initials on the strips validating the time, temperature, dry time and completion of the cycle. Review of the envelope dated 11/03/2015 revealed four loads run. Review of the strips revealed a total eight loads run. Review revealed three loads was run as controls and one "prevac" by central sterile reprocessing staff. Review of the strips revealed four (4) loads (cycles) of surgical instruments processed as "flash" (immediate use sterilization) at 0719, 0737, 0911 and 1218. Review revealed no initials on the strips validating the time, temperature, dry time and completion of the cycle. Review of the envelope dated 11/04/2015 revealed four loads run. Review of the strips revealed a total five loads run. Review revealed three loads was run as controls by central sterile reprocessing staff. Review of the strips revealed two (2) loads (cycles) of surgical instruments processed as "flash" (immediate use sterilization) at 0949 and 1528. Review revealed no initials on the strips validating the time, temperature, dry time and completion of the cycle. Review of the envelope dated 11/07/2015 revealed three loads run. Review of the strips revealed a total four loads run. Review revealed three loads was run as controls by central sterile reprocessing staff. Review of the strips revealed one (1) load (cycle) of surgical instruments processed as "flash" (immediate use sterilization) at 1057. Review revealed no initials on the strips validating the time, temperature, dry time and completion of the cycle. Review of the envelope dated 11/09/2015 revealed three loads run. Review of the strips revealed a total four loads run. Review revealed three loads was run as controls by central sterile reprocessing staff. Review of the strips revealed one (1) load (cycle) of surgical instruments processed as "flash" (immediate use sterilization) at 0723. Review revealed no initials on the strips validating the time, temperature, dry time and completion of the cycle. Review of the envelope dated 11/11/2015 revealed three loads run. Review of the strips revealed a total five loads run. Review revealed three loads was run as controls by central sterile reprocessing staff. Review of the strips revealed two (2) loads (cycles) of surgical instruments processed as "flash" (immediate use sterilization) at 1035 and 1035. Review revealed no initials on the strips validating the time, temperature, dry time and completion of the cycle. Review of the envelope dated 11/16/2015 revealed five loads run. Review of the strips revealed a total five loads run. Review revealed three loads was run as controls by central sterile reprocessing staff. Review of the strips revealed two (2) loads (cycles) of surgical instruments processed as "flash" (immediate use sterilization) at 0737 and 0757. Review revealed no initials on the strips validating the time, temperature, dry time and completion of the cycle. Review of the envelope dated 11/18/2015 revealed seven loads run. Review of the strips revealed a total seven loads run. Review revealed three loads was run as controls by central sterile reprocessing staff. "Load #4" parameters on printout are illegible unable to determine type of load run. Review of the strips revealed three (3) loads (cycles) of surgical instruments processed as "flash" (immediate use sterilization) at 1232, 1353 and 1604 revealed no initials on the strips validating the time, temperature, dry time and completion of the cycle. Review of the envelope dated 11/20/2015 revealed three loads run. Review of the strips revealed three "flash" cycles that were legible, portions of the strip were illegible and unable to determine the total loads. Review of the strips revealed three (3) loads (cycles) of surgical instruments processed as "flash" (immediate use sterilization) at 0926, 0947, and 1319. Review revealed no initials on the strips validating the time, temperature, dry time and completion of the cycle. Review of the envelope dated 11/22/2015 revealed three loads run. Review of the strips revealed that no cycles/ loads were legible. Unable to determine how many or type of cycles run on the autoclave. Review of the envelope dated 11/24/2015 revealed five loads run. Review of the strips revealed a total eight loads run. Review revealed three loads was run as controls and two as "prevac" by central sterile reprocessing staff. Review of the strips revealed three (3) loads (cycles) of surgical instruments processed as "flash" (immediate use sterilization) at 1236, 1449 and 1502. Review revealed no initials on the strips validating the time, temperature, dry time and completion of the cycle. Review of the envelope dated 11/27/2015 revealed three loads run. Review of the strips revealed a total five loads run. Review revealed three loads was run as controls by central sterile reprocessing staff. Review of the strips revealed two (2) loads (cycles) of surgical instruments processed as "flash" (immediate use sterilization) at 0651 and 1246. Review revealed no initials on the strips validating the time, temperature, dry time and completion of the cycle. Documentation review revealed a total of twenty-seven (27) immediate use sterilization cycles not validated for time, temperature and dry time according to policy for autoclave identified as "5-7" for November 2015.



16369

Hospital documentation review on 12/04/2015 at 0900 of Autoclave identified as "10" revealed 19 "Steam Flash Sterilization Record Keeping Envelopes" for November 2015. Review of the envelope dated 11/03/2015 revealed a total of 4 loads run. Review of the strips revealed a total of 6 loads run. Review revealed the first three loads were run as controls by central sterile reprocessing staff. Review of the strips revealed two (2) loads (cycles) of surgical instruments processed as "flash" (immediate use sterilization) at 1142 and 1331. Review revealed no initials on the strips validating the time, temperature, dry time and completion of the cycle. Review of the envelope dated 11/04/2015 revealed a total of 3 loads run. Review of the strips revealed a total of 4 loads run. Review revealed the first three loads were run as controls by central sterile reprocessing staff. Review of the strips revealed one (1) load (cycle) of surgical instruments processed as "flash" at 1315. Review revealed no initials on the strip validating the time, temperature, dry time and completion of the cycle. Review of the envelope dated 11/05/2015 revealed a total of 3 loads run. Review of the strips revealed a total of 4 loads run. Review revealed the first three loads were run as controls by central sterile reprocessing staff. Review of the strips revealed one (1) load (cycle) of surgical instruments processed as "flash" at 1527. Review revealed no initials on the strip validating the time, temperature, dry time and completion of the cycle. Review of the envelope dated 11/18/2015 revealed a total of 4 loads run. Review of the strips revealed a total of 4 loads run. Review revealed the first three loads were run as controls by central sterile reprocessing staff. Review of the strips revealed one (1) load (cycle) of surgical instruments processed as "flash" at 1416. Review revealed no initials on the strip validating the time, temperature, dry time and completion of the cycle. Review of the envelope dated 11/23/2015 revealed a total of 3 loads run. Review of the strips revealed a total of 4 loads run. Review revealed the first three loads were run as controls by central sterile reprocessing staff. Review of the strips revealed one (1) load (cycle) of surgical instruments processed as "flash" at 1451. Review revealed no initials on the strip validating the time, temperature, dry time and completion of the cycle. Review of the envelope dated 11/24/2015 revealed a total of 4 loads run. Review of the strips revealed a total of 5 loads run. Review revealed the first three loads were run as controls by central sterile reprocessing staff. Review of the strips revealed two (2) loads (cycles) of surgical instruments processed as "flash" at 0935 and 1623. Review revealed no initials on the strip validating the time, temperature, dry time and completion of the cycle. Review of the envelope dated 11/25/2015 revealed a total of 4 loads run. Review of the strips revealed a total of 5 loads run. Review revealed the first three loads were run as controls by central sterile reprocessing staff. Review of the strips revealed two (2) loads (cycles) of surgical instruments processed as "flash" at 0812 and 1244. Review revealed no initials on the strip validating the time, temperature, dry time and completion of the cycle. Review of the envelope dated 11/30/2015 revealed a total of 4 loads run. Review of the strips revealed a total of 5 loads run. Review revealed the first three loads were run as controls by central sterile reprocessing staff. Review of the strips revealed two (2) loads (cycles) of surgical instruments processed as "flash" at 1756 and 1837. Review revealed no initials on the strip validating the time, temperature, dry time and completion of the cycle. Documentation review revealed a total of twelve (12) immediate use sterilization cycles not validated for time, temperature and dry time according to policy for autoclave identified as "10" for November 2015.

Review of the "Steam Flash Sterilization Record Keeping Envelopes" for November 2015 on 12/04/2015 at 0900 of Autoclave identified as "1-2" revealed a total of 18 envelopes (days the autoclave was used). Review of the envelope dated 11/02/2015 revealed a total of 1 load run. Review of the strips revealed a total of 3 loads run. Review revealed the first load was run as a control by central sterile reprocessing staff. Review of the strips revealed two (2) loads (cycles) of surgical instruments processed as "flash" (immediate use sterilization) at 1050 and 1231. Review revealed no initials on the strips validating the time, temperature, dry time and completion of the cycle. Review of the envelope dated 11/03/2015 revealed a total of 1 load run. Review of the strips revealed a total of 2 loads run. Review revealed the first load was run as a control by central sterile reprocessing staff. Review of the strips revealed one (1) load (cycle) of surgical instruments processed as "flash" at 1114. Review revealed no initials on the strips validating the time, temperature, dry time and completion of the cycle. Review of the envelope dated 11/09/2015 revealed a total of 1 load run. Review of the strips revealed a total of 2 loads run. Review revealed the first load was run as a control by central sterile reprocessing staff. Review of the strips revealed one (1) load (cycle) that was illegible with no initials on the strip validating the time, temperature, dry time and completion of the cycle. Review of the envelope dated 11/12/2015 revealed a total of 1 load run. Review of the strips revealed a total of 2 loads run. Review revealed the first load was run as a control by central sterile reprocessing staff. Review of the strips revealed one (1) load (cycle) of surgical instruments processed as "flash" at 1235. Review revealed no initials on the strips validating the time, temperature, dry time and completion of the cycle. Review of the envelope dated 11/18/2015 revealed a total of 1 load run. Review of the strips revealed a total of 2 loads run. Review revealed the first load was run as a control by central sterile reprocessing staff. Review of the strips revealed one (1) load (cycle) of surgical instruments processed as "flash" at 1425. Review revealed no initials on the strips validating the time, temperature, dry time and completion of the cycle. Review of the envelope dated 11/19/2015 revealed a total of 1 load run. Review of the strips revealed a total of 2 loads run. Review revealed the first load was run as a control by central sterile reprocessing staff. Review of the strips revealed one (1) load (cycle) of surgical instruments processed as "flash" at 1326. Review revealed no initials on the strips validating the time, temperature, dry time and completion of the cycle. Review of the envelope dated 11/23/2015 revealed a total of 1 load run. Review of the strips revealed a total of 2 loads run. Review revealed the first load was run as a control by central sterile reprocessing staff. Review of the strips revealed one (1) load (cycle) of surgical instruments processed as "flash" at 0938. Review revealed no initials on the strips validating the time, temperature, dry time and completion of the cycle. Documentation review revealed a total of eight (8) immediate use sterilization cycles not validated for time, temperature and dry time according to policy for autoclave identified as "10" for November 2015.

Interview on 12/03/2015 at 1630 with OR Nurse #1 confirmed nurses are not consistent with their documentation on the log (envelope) and some do not document on the log at all and only in Epic (electronic medical record). Interview revealed "Personally, I only document in Epic since it went live. We were told we didn't have to document on the log anymore" Interview revealed Epic went live in March 2014.

Interview on 12/04/2015 at 1500 with OR-AS #2 confirmed after review of sample of "Steam Flash Sterilization Record Keeping Envelopes" and Autoclave printout documentation there was no validation of the sterilization time, temperature and dry time with the use of immediate use sterilizers in the operating room prior to the instruments placed into use. Interview revealed staff were told to stop documenting on the log by the prior operating room director when they went live with Epic. Interview revealed this practice is not consistent with policy or standard practice.

2. Review of "SURGICAL SERVICES POLICY STATEMENT.. CENTRAL STERILE REPROCESSING....POLICY NAME: Pre-Vacuum Steam Sterilizers (#9, 10, 20, 30 and 13) Operations and daily monitoring of EFFECTIVE DATE: 2/90 REVIEW/REVISION HISTORY: 12/12..... POLICY: Pre-Vacuum Steam Sterilizers (#10, 20 and 13) will be operated per the manufacturer's instructions. If there is a time when there is more than one manufacturer's recommended operation instruction, the most strict (higher standard) will be followed. Monitoring of the Prevacuum Sterilizer 1. Leak Test Monitoring.... will be done once a week on all prevacuum sterilizers."

Review of manufacturer's recommendations for the types of steam sterilizers used in the operating room revealed leak testing is recommended to be done weekly for 9 of the 11 autoclaves (not required on autoclave #1-2 and #3-4 due to only used for IUSS).

Observation and interview with ICP #3 and OR-AS #2 during tour on 12/04/2015 at 1630 revealed Autoclave 10 was a prevacuum sterilizer. Review of the "Steam Flash Sterilization Record Keeping Envelopes" for November 2015 for Autoclave 10 revealed the autoclave was used 19 days from 11/02/2015 through 11/30/2015. Review of the envelopes revealed no leak testing was done on Autoclave 10 in November 2015.

Observation and interview with ICP #3 and OR-AS #2 during tour on 12/04/2015 at 1630 revealed Autoclave 9 was a prevacuum sterilizer. Review of the "Steam Flash Sterilization Record Keeping Envelopes" for November 2015 for Autoclave 9 revealed the autoclave was used 21 days from 11/02/2015 through 11/30/2015. Review of the envelopes revealed leak testing was done on 11/02/2015, 11/16/2015 (14 days since prior leak testing) and 11/23/2015. Review revealed weekly leak testing was not done according to policy between 11/02/2015 and 11/16/2015.

Observation and interview with ICP #3 and OR-AS #2 during tour on 12/04/2015 at 1630 revealed Autoclave 6-8 was a prevacuum sterilizer. Review of the "Steam Flash Sterilization Record Keeping Envelopes" for November 2015 for Autoclave 6-8 revealed the autoclave was used 28 days from 11/01/2015 through 11/30/2015. Review revealed no leak testing was done on Autoclave 6-8 in November 2015.

Observation and interview with ICP #3 and OR-AS #2 during tour on 12/04/2015 at 1630 revealed Autoclave 11-12 was a prevacuum sterilizer. Review of the "Steam Flash Sterilization Record Keeping Envelopes" for November 2015 for Autoclave 11-12 revealed the autoclave was used 27 days from 11/02/2015 through 11/30/2015. Review revealed no leak testing was done on Autoclave 11-12 in November 2015.

Observation and interview with ICP #3 and OR-AS #2 during tour on 12/04/2015 at 1630 revealed Autoclave 14-16 was a prevacuum sterilizer. Review of the "Steam Flash Sterilization Record Keeping Envelopes" for November 2015 for Autoclave 14-16 revealed the autoclave was used 19 days from 11/02/2015 through 11/30/2015. Review revealed no leak testing was done on Autoclave 11-12 in November 2015.

Observation and interview with ICP #3 and OR-AS #2 during tour on 12/04/2015 at 1630 revealed Autoclave 5-7 was a prevacuum sterilizer. Review of the "Steam Flash Sterilization Record Keeping Envelopes" for November 2015 for Autoclave 5-7 revealed the autoclave was used 11/01/2015 through 11/30/2015. Review revealed no leak testing was done on Autoclave 5-7 in November 2015.

3. Review of "SURGICAL SERVICES POLICY STATEMENT.. CENTRAL STERILE REPROCESSING....POLICY NAME: Vendor (Loaner) Trays EFFECTIVE DATE: 03/2012 no noted review or revision history... POLICY: All Loaner instruments, instruments not owned by the facility, must be received, inspected, recorded, decontaminated and sterilized in there Sterile Processing department according to the manufacturer's instructions. All items are considered "non-sterile" anytime instrumentation is provided as a loaner from any company and/or its representative... Central Sterile Reprocessing Department (CSR) ...5. Item(s)/tray(s) must be decontaminated after use and returned to the loaner room as clean. 11. Once cleaned, the loaner sets shall be transported to a holding area for pick up by the vendor representative. These trays should be picked up with in two (2) business days post- procedure."

Observation during tour of the "Vendor Room" with ICP #3 and CSR-AS #4 central sterile reprocessing administrative staff members (CSR staff # on 12/03/2015 at 1115 revealed a storage area located in the basement of the hospital that was unsecured. Observation revealed vendor shelving separated areas for each vendor. Observation revealed four sterilized vendor spinal trays located on a shelf. Observation revealed the sterilized trays were identified as "MARS 3V, date of surgery 12-2 2:30"; "MARS 3V Back Up, date of surgery 12-2 2:45"; Angled LDP Back Up, date of surgery 12-2 2:45"; and "Lnr (Vendor name) Instrument Tray" with a bar code scan and date of 12/2/15. Further review of the vendor trays revealed the trays had external sterilizer tape indicating the trays were sterile and ready for use. Further observation revealed three peel packs containing instruments that were sterilized and ready for use. Observation revealed another vendor shelf that contained 19 peel packs containing surgical instruments that had been sterilized and were ready for use.

Interview on 12/03/2015 at 1115 during the tour of the vendor room with ICP #3 and CSR-AS #4 revealed the four spine trays appeared to be sterilized and ready for use. The staff members stated the packs should go back to central sterile reprocessing (CSR) to be decontaminated and re-sterilized because the trays are considered dirty once they leave the CSR and surgical suite areas. The CSR-AS #4 staff member stated "These are sterilized. They should not be down here. They are available for use." The staff members revealed that if these trays were taken to the operating room, they would appear to be okay for use. Interview revealed there was no way to tell that the trays were stored in the vendor room and should not be used. Interview revealed that the surgical instruments in peel packs were sterilized and ready for use. Interview revealed these items should not be stored in the vendor room as sterilized items. Interview revealed the instruments in peel packs should be returned to CSR for reprocessing. Interview revealed no sterilized instruments or trays should be stored in the vendor room.

Interview on 12/03/2015 at 1520 with Vendor #5 revealed the vendor representative worked with spine surgeons and was in the operating room daily for the past two years. Interview revealed Vendor #5 had trays that were "coming into the hospital today. They will go to the basement vendor room." Interview revealed the trays would come to the hospital clean and then go to the decontamination room in CSR to be washed and sterilized. Interview revealed the vendor had three carts for storing vendor trays and there was specified space in the instrument storage area for vendor trays. Interview with the vendor revealed that sterile trays should not be stored in the vendor room.


NC00112392