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Based on medical record review, staff interview, review of records of QAPI activities, and instrument inspection and surgical logs, policies, and manufacture's recommendations, and correspondence with the State Epidemiologist, the governing body failed to require the hospital to implement performance improvement initiatives for recurrent problems in surgical safety (A940) and infection prevention related to cleaning and sterilizing surgical instruments (A747). The recurrent failure to identify and resolve potentially unsafe practices (A263) resulted in a determination the hospital did not meet the Condition of Participation for Governing Body.

Based on staff interview, review of QAPI activities records, and instrument inspection and surgical logs, the facility failed to implement performance improvement initiatives for recurrent problems in surgical safety related to cleaning and sterilizing surgical instruments. The failure to resolve this problem in 2013, 2014, and 2015, has resulted in increased preventable risks in surgical services and a determination the facility failed to meet the Condition of Participation for Quality Assessment and Program Improvement (A286).

Based on staff interview, review of QAPI activities records, and instrument inspection and surgical logs, the facility failed to implement performance improvement initiatives for recurrent problems in surgical safety related to cleaning and sterilizing surgical instruments. The findings were:

Interview on 6/16/15 at 4:30 PM with the infection preventionist and review of the causal analysis report revealed the following information: A small amount of reddish material was identified on the end of an ENT 4 millimeter zero degree scope on 6/9/15. The surgery had been going on for an hour when the surgeon noted the "contaminated scope" and discarded it prior to use. The "contaminated scope" had been through the cleaning, sterilization, and packaging process. This instrument was submitted to laboratory tests that showed negative culture results. The following concerns were identified:

1. Review of the QAPI information showed no evidence the facility utilized the QAPI process to address the problems with unclean surgical instruments.

2. During an interview on 6/29/15 at 11 AM, surgeon #1 stated the substance on this instrument was noted prior to use, but there was continued concern that substances and biofilm on other instruments might not be detected prior to use. He further stated this would continue to be a concern until the facility implemented an effective surgical instrument cleaning and sterilization process.

3. Interviews with RN #1 on 6/18/15 at 11:50 AM and surgeon #1 on 6/29/15 at 11 AM revealed surgical instruments with biofilm, substances, and/or debris were noted during two surgeries in 2013 and again in 2014. During the interview with surgeon #1 he stated he asked the administrative staff to address this problem each time it occurred in 2013, 2014 and in 2015 without positive results.

4. The facility was unable to provide the surveyor requested information regarding how the problem was addressed in 2013. Interview with the IP on 6/18/15 at 11:55 AM confirmed the lack of documentation and information regarding the 2013 incidents.

5. Review of the facility's documentation of the 2014 incident showed the facility implemented a process using a magnifying glass to inspect surgical instruments prior to sterilization to prevent using instruments with biofilm and unclean substances. Further review of the documentation showed the instruments that required this inspection were packaged sets for FESS and septoplasty surgeries. At that time they also developed an instrument inspection log. Review of the April 2015 to June 5, 2015 instrument inspection log and surgery log with the surgical services manager on 6/17/15 at 4:30 PM revealed all of the FESS and Septoplasty instrument sets had not been inspected with the magnifying glass prior to sterilization. At that time, the surgical services manager further stated it should have been done and documented on the log.

6. Interview with the IP on 6/18/15 at 11:40 AM acknowledged the facility's failure to implement effective measures to resolve the problems. She further stated this problem was not being addressed in the QAPI process.

Based on staff interview, review of medical records, review of manufacture's recommendations, policies, and instrument inspection and surgical logs, and correspondence with the State Epidemiologist, the facility failed to ensure effective infection prevention measures were implemented for the surgical instrument cleaning and sterilization process. The lack of sustained effective measures resulted in increased risk in patient safety and a determination the facility did not meet the Condition of Participation for Infection Control (A749).

Based on staff interview, review of manufacture's recommendations, policies, and instrument inspection and surgical logs, the facility failed to ensure effective infection prevention measures were implemented for the surgical instrument cleaning and sterilization process. The findings were:

Interview on 6/16/15 at 4:30 PM with the infection preventionist and review of the causal analysis report revealed the following information: A small amount of reddish material was identified on the end of an ENT 4 millimeter zero degree scope on 6/9/15. The surgery had been going on for an hour when the surgeon noted the "contaminated scope" and discarded it prior to use. The "contaminated scope" had been through the cleaning, sterilization, and packaging process. This instrument was submitted to laboratory tests that showed negative culture results. The following concerns were identified:

1. During an interview on 6/29/15 at 11 AM, surgeon #1 stated the substance on this instrument was noted prior to use, but there was continued concern that substances and biofilm on other instruments might not be detected prior to use. He further stated this would continue to be a concern until the facility implemented an effective surgical instrument cleaning and sterilization process.

2. According to the State Epidemiologist on 6/22/15 at 9:23 AM, instruments should be free from debris; and if debris is allowed one would not be certain that in every instance there are no viable organisms.

3. Interviews with RN #1 on 6/18/15 at 11:50 AM and surgeon #1 on 6/29/15 at 11 AM revealed surgical instruments with biofilm, substances, and/or debris were noted during two surgeries in 2013 and again in 2014. During the interview with surgeon #1 he stated he asked the administrative staff to address this problem each time it occurred in 2013, 2014 and in 2015 without positive results.

4. The facility was unable to provide the surveyor requested information regarding how the problem was addressed in 2013. Interview with the IP on 6/18/15 at 11:55 AM confirmed the lack of documentation and information regarding the 2013 incidents.

3. Review of the facility's documentation of the 2014 incident showed the facility implemented a process using a magnifying glass to inspect surgical instruments prior sterilization to prevent using instruments with biofilm and unclean substances. Further review of the documentation showed the instruments that required this inspection were packaged sets for FESS and septoplasty surgeries. At that time they also developed an instrument inspection log. Review of the April 2015 to June 5, 2015 instrument inspection log and surgery log with the surgical services manager on 6/17/15 at 4:30 PM revealed all of the FESS and Septoplasty instrument sets had not been inspected with the magnifying glass prior to sterilization. At that time the surgical services manager further stated it should have been done and documented on the log.

4. Interview with the sterile processing nurse on 6/17/15 at 9:40 AM revealed the unclean instrument that was identified in 2015 was not included in the FESS and Septoplasty sets and had not been identified as an instrument that needed magnifying glass inspection. She further stated the facility did not completed a review of all smaller surgical instruments to determine the ones that needed to be inspected with the magnifying glass after the 2014 incident, but limited the process to the FESS and Septoplasty sets.

5. Interview with the sterile processing nurse on 6/17/15 at 9:40 AM revealed the substance on the instrument was not visible with the magnifying glass. She further stated there had been no discussion or follow-up to determine if this type of magnifying glass had the capability to do the in-depth inspection that was needed.

6. Review of the 6/12/15 causal analysis report did not include a system for patient follow up to identify whether patients had been impacted by the lack of an effective system for cleaning instruments. Review of 21 sample patients revealed one patient (#8) developed an elevated temperature 3 days after receiving the type of surgery that involved instruments that required inspection with the magnifying glass. Interview with the IP on 6/17/15 at 4:15 PM revealed there had been no review of this patient's record to determine if there was a relationship between the elevated temperatures and possible use of unclean, sterilized instruments.

7. According to the American Journal of Infection Control, May 2015, Volume 43, "The accumulation of proteins, salts, and dirt on MDs [medical devices] protects microorganisms from direct contact with sterilizing agents and favors bacterial adherence and biofilm formation. To be effective, the cleaning methods used must substantially reduce the levels of infectious agents present on MDs, such as bacteria, endotoxins, fungi, viruses, organic and inorganic matter that allow material growth and survival, and potential pyroxenes".

8. According to AORN 2012 Perioperative Standards and Recommended Practices, "Care of Instruments, Recommendation IV, section IV.a., "...Blood and body fluids, as well as saline, are highly corrosive. Corrosion, rusting, and pitting occur when saline, blood, and debris are allowed to dry in or on surgical instruments. Dried blood and debris can be difficult, if not impossible, to remove from all surfaces during the decontamination process; therefore, subsequent disinfection or sterilization may not be achieved".

9. Review of the policy for Sterilization of Instruments and Supplies, 11-62, revised June 2015, showed, "The reliability of sterilization is determined by the number, type, and inherent resistance of organisms on the item. It is also affected by surrounding soil, oils, or other items that interfere with the sterilizing agent."... "Articles to be sterilized must be decontaminated, cleaned, and inspected before wrapping".

Based on staff interview, review of manufacture's recommendations, policies, and instrument inspection and surgical logs, and correspondence with the State Epidemiologist, the facility failed to ensure effective infection prevention measures were implemented for the surgical instrument cleaning and sterilization process.This failure resulted in increased risk to patients safety and a determination the hospital did not meet the Condition of Participation for Surgical Services. The findings were:

Interview on 6/16/15 at 4:30 PM with the infection preventionist and review of the causal analysis report revealed the following information: A small amount of reddish material was identified on the end of an ENT 4 millimeter zero degree scope on 6/9/15. The surgery had been going on for an hour when the surgeon noted the "contaminated scope" and discarded it prior to use. The "contaminated scope" had been through the cleaning, sterilization, and packaging process. This instrument was submitted to laboratory tests that showed negative culture results. The following concerns were identified:

1. During an interview on 6/29/15 at 11 AM, surgeon #1 stated the substance on this instrument was noted prior to use, but there was continued concern that substances and biofilm on other instruments might not be detected prior to use. He further stated this would continue to be a concern until the facility implemented an effective surgical instrument cleaning and sterilization process.

2. According to the State Epidemiologist on 6/22/15 at 9:23 AM, instruments should be free from debris; and if debris is allowed one would not be certain that in every instance there are no viable organisms.

3. Interviews with RN #1 on 6/18/15 at 11:50 AM and surgeon #1 on 6/29/15 at 11 AM revealed surgical instruments with biofilm, substances, and/or debris were noted during two surgeries in 2013 and again in 2014. During the interview with surgeon #1 he stated he asked the administrative staff to address this problem each time it occurred in 2013, 2014 and in 2015 without positive results.

4. The facility was unable to provide the surveyor requested information regarding how the problem was addressed in 2013. Interview with the IP on 6/18/15 at 11:55 AM confirmed the lack of documentation and information regarding the 2013 incidents.

5. Review of the facility's documentation of the 2014 incident showed the facility implemented a process using a magnifying glass to inspect surgical instruments prior sterilization to prevent using instruments with biofilm and unclean substances. Further review of the documentation showed the instruments that required this inspection were packaged sets for FESS and septoplasty surgeries. At that time they also developed an instrument inspection log. Review of the April 2015 to June 5, 2015 instrument inspection log and surgery log with the surgical services manager on 6/17/15 at 4:30 PM revealed all of the FESS and Septoplasty instrument sets had not been inspected with the magnifying glass prior to sterilization. At that time, the surgical services manager further stated it should have been done and documented on the log.

6. Interview with the sterile processing nurse on 6/17/15 at 9:40 AM revealed the unclean instrument that was identified in 2015 was not included in the FESS and Septoplasty sets and had not been identified as an instrument that needed magnifying glass inspection. She further stated the facility did not completed a review of all smaller surgical instruments to determine the ones that needed to be inspected with the magnifying glass after the 2014 incident, but limited the process to the FESS and Septoplasty sets.

7. Interview with the sterile processing nurse on 6/17/15 at 9:40 AM revealed the substance on the instrument was not visible with the magnifying glass. She further stated there had been no discussion or follow-up to determine if this type of magnifying glass had the capability to do the in-depth inspection that was needed.

8. Review of the 6/12/15 causal analysis report did not include a system for patient follow-up to identify whether patients had been impacted by the lack of an effective system for cleaning instruments. Review of 21 sample patients revealed one patient developed an elevated temperature 3 days after receiving the type of surgery that involved instruments that required inspection with the magnifying glass. Interview with the IP on 6/17/15 at 4:15 PM revealed there had been no review of this patient's record to determine if there was a relationship between the elevated temperatures and possible use of unclean, sterilized instruments.

9. According to the American Journal of Infection Control, May 2015, Volume 43, "The accumulation of proteins, salts, and dirt on MDs [medical devices] protects microorganisms from direct contact with sterilizing agents and favors bacterial adherence and biofilm formation. To be effective, the cleaning methods used must substantially reduce the levels of infectious agents present on MDs, such as bacteria, endotoxins, fungi, viruses, organic and inorganic matter that allow material growth and survival, and potential pyroxenes".

10. According to AORN 2012 Perioperative Standards and Recommended Practices, "Care of Instruments, Recommendation IV, section IV.a., "...Blood and body fluids, as well as saline, are highly corrosive. Corrosion, rusting, and pitting occur when saline, blood, and debris are allowed to dry in or on surgical instruments. Dried blood and debris can be difficult, if not impossible, to remove from all surfaces during the decontamination process; therefore, subsequent disinfection or sterilization may not be achieved".

11. Review of the policy for Sterilization of Instruments and Supplies, 11-62, revised June 2015, showed, "The reliability of sterilization is determined by the number, type, and inherent resistance of organisms on the item. It is also affected by surrounding soil, oils, or other items that interfere with the sterilizing agent."... "Articles to be sterilized must be decontaminated, cleaned, and inspected before wrapping".