HospitalInspections.org

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Based on observation, staff interview, and review of medical records, root cause analysis reports, photographs of unclean surgical instruments, facility documentation, procedure standards, compliance monitoring records, temperature and humidity logs, and temperature and humidity monitoring instructions, the governing body failed to ensure the Quality Assessment and Performance Improvement (QAPI) program effectively addressed uncorrected system failures (A263); and failed to ensure sustaining measures were implemented to address ongoing breaches in infection control practices (A747); as well as out of acceptable range humidity levels in the OR, sub-sterile room and endoscopy rooms (A726). The cumulative effect of these findings resulted in a determination that the Condition of Participation for Governing Body was not met. The findings were:

1. Refer to A263 for evidence of the facility's failure to effectively utilize the QAPI process to maintain ongoing compliance in recurrent deficient areas.

2. Refer to A747 and A951 for evidence of ongoing breaches in infection control practices.

3. Refer to A726 for evidence of the facility's ongoing failure to maintain humidity levels in the ORs, sub-sterile room and endoscopy rooms at an acceptable range.

4. During an interview on 10/19/16 at 2:18 PM, the Interim CEO acknowledged the facility had not completely resolved all of the problems that were identified during the 5/5/16 validation survey. He further stated improvement in effective communication, cohesiveness within staff, and professional relationships between administration and medical staff were needed to resolve the problems.
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Based on observation, interview with staff, review of medical records, root cause analysis reports, procedure standards, compliance monitoring records, temperature and humidity logs, and temperature and humidity monitoring instructions, the facility failed to utilize the quality assessment and performance improvement process to ensure ongoing compliance related to infection control and the proper processing of surgical instruments and safe injection practices; as well as maintaining humidity in ORs, the sub-sterile room, and endoscopy rooms within an acceptable range (A308). The cumulative effect of the deficient practice resulted in a determination that the hospital failed to meet the Condition of Participation for Quality Assessment and Performance Improvement.

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Based on observation, interview with staff, review of medical records, root cause analysis reports, procedure standards, compliance monitoring records, temperature and humidity logs, and temperature and humidity monitoring instructions, the facility failed to utilize the quality assessment and performance improvement process to identify and address recurrent issues identified during the 5/5/16 validation survey. The ongoing deficient practice was in the areas of infection control and acceptable humidity levels in the OR, sub-sterile room, and endoscopy rooms. The findings were:

1. Refer to A749 for evidence of the facility's failure to identify and implement measures to address ongoing breaches in infection control practices. Interview on 10/17/16 at 3:15 PM with the assistant CNO revealed unclean surgical instruments were found in the operating room during a surgical procedure in June 2016, and prior to surgery in July 2016 and September 2016. The CNO stated staff education and competency testing were completed for all staff responsible for cleaning and sterilizing instruments, and additional steps in the sterilization process were implemented to address the problem. On 10/19/16 at 2:15 PM she acknowledged the problem continued to occur even though the above measures had been implemented. In addition, on 10/18/16 and 10/19/16, ongoing unsafe injection practices were observed.

2. Refer to A726 for evidence of the facility's ongoing failure to maintain humidity levels within acceptable range in the OR, sub-sterile room and endoscopy room. Interview with the director of plant operations on 10/18/16 at 1:30 PM confirmed the facility had issues with humidity levels at both locations. The facility planned to contract with an outside entity to address this issue. However, the facility failed to have a plan with a specific timeframe.

3. During an interview on 10/19/16 at 1:55 PM the regulatory coordinator stated staff had made improvements since the 5/5/16 validation survey, and the facility's desired goals for quality care had been achieved in some, but not all areas.
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16146

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Based on review of temperature and humidity logs, review of the facility plan of correction, review of temperature and humidity monitoring instructions, and staff interview, the facility failed to ensure the humidity was maintained at an acceptable level in the ORs, sub-sterile room and endoscopy room in 2 of 2 facility locations (Lander, Riverton). The findings were:

Review of the 10/13/16 "Temperature and Humidity Monitoring for Surgery" instructions showed the following: "Lander: Security will check temperatures and humidity and document on the log in each room at the end of the shift (0500). Adjust thermostat if out of range. Surgery will perform cases and adjust temperature for patient care as needed. Surgery Unit Coordinator will adjust temperatures back as needed after patient care. Maintenance will check temperatures and humidity at end of shift (1700) and adjust if out of range. Riverton: Surgery Unit Coordinator will check temperatures and humidity and document on log in room. Adjust thermostat if out of range/FollowUp with 2nd reading/Place Work Order if not able to correct to acceptable range. Surgery will perform cases and adjust temperature for patient care as needed. Surgery Unit Coordinator will adjust temperatures back as needed after patient care. Maintenance will check temperatures and humidity at end of shift (1500) and adjust if out of range."

Review of the facility plan of correction for the 5/5/16 validation survey showed the following: "Sage West ensures the humidity is maintained at an acceptable level in the ORs and endoscopy room." Review of the humidity logs showed the humidity was to remain between 30% and 60%. The following issues were identified:

1. Issues with humidity at the Riverton location:
a. Review of the July 2016 log for OR #1 showed the humidity was less than 30% on 4 days, 4 days in OR #2, 6 days in the Substerile room, and 3 days in the Endoscopic Procedure room.
b. Review of the August 2016 log for OR #2 room showed the humidity was less than 30% on 3 days, 5 days in the Endoscopic Procedure room, 10 days in the Substerile room, and 9 days in OR #1.
c. Review of the September 2016 log for OR #1 showed the humidity was less than 30% on 10 days, 4 days in OR #2, 6 days in the Endoscopic Procedure room, and 6 days in the Substerile room.
d. Review of the October 2016 log for OR #1 showed the humidity was less than 30% on 12 days, 12 days in the Substerile room, 4 days in OR #2, and 8 days in the Endoscopic Procedure room.

2. Issues with humidity at the Lander location:
a. Review of the July 2016 log for OR #5 showed the humidity was less than 30% on 3 days, 4 days in OR #6, 4 days in OR #3, 4 days in OR #4, 4 days in sub-sterile room #A, and 4 days in sub-sterile room #C.
b. Review of the September 2016 log for OR #3 showed the humidity was less than 30% on 3 days, 2 days in OR #4, and 9 days in Substerile room #A.

3. Review of the temperature and humidity logs for both locations showed the form had an area for corrective action by maintenance. The area was either left blank or documented that maintenance was notified on the forms, with no details of corrective action documented.

4. Interview with the director of plant operations on 10/18/16 at 1:30 PM confirmed the facility had issues with humidity levels at both locations. The facility planned to contract with an outside entity to address this issue. However, the facility failed to have a plan with a specific timeframe.
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Based on observation of photographed unclean surgical instruments, interview with staff, review of medical records, root cause analysis reports, facility documentation and review of procedure standards and compliance monitoring records, and observation of anesthesia medication administration, the facility failed to ensure acceptable standards of infection control practices were used for cleaning, inspecting, and sterilizing surgical instruments and administering intravenous medications (A749). The cumulative effect of the deficient practice resulted in a determination that the hospital failed to meet the Condition of Participation for Infection Control.
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Based on observation of photographed unclean surgical instruments, interview with staff, and review of medical records, root cause analysis reports, and facility documentation, the hospital failed to complete the cleaning, inspection, and sterilization process necessary to ensure surgical instruments were free from potential infectious materials. The failure to follow acceptable standards of infection control practices resulted in potential harm for 4 of 4 sample patients (#4, #5, #6, #7) who had scheduled outpatient surgeries. Two patients (#4, #6) were exposed to unclean instruments during surgery; 1 patient (#5) was in the operating room when unclean instruments were removed prior to use; and 1 patient (#7) was anesthetized for 34 minutes while staff replaced the contaminated instrument tray. In addition based on observations, staff interview, and review of procedure standards and compliance monitoring records, the hospital failed to ensure staff used safe injection practices for 2 of 2 sample patients (#8, #9) observed during intravenous medication administration. The findings were:

1. Interview on 10/17/16 at 3:15 PM with the assistant CNO revealed unclean surgical instruments were found in the operating room during a surgical procedure in June 2016, and prior to surgery in July 2016 and September 2016. The CNO stated staff education and competency testing was completed for all staff responsible for cleaning and sterilizing instruments, and additional steps in the sterilization process were implemented to address the problem. However, on 10/19/16 at 2:15 PM she acknowledged the facility's efforts had not resolved this recurring problem. The following concerns were identified:
a. Review of the medical record revealed surgeon #1 performed surgery for patient #4 on 6/3/16. Further review revealed the surgeon placed an instrument for suctioning in the surgery area and the instrument did not function properly due to clogged dried blood in the small lumens. A replacement instrument was checked prior to use and dried blood was found on this instrument too. A third instrument was used to complete the surgery. Review of the root cause analysis revealed the instruments were not properly cleaned and inspected. Interview with the assistant CNO on 10/17/16 at 3:15 PM revealed blood cultures were completed for patient #4 and the patient whose surgery required the same instruments before they were used for patient #4. She further stated the results were negative.
b. Review of the medical record revealed surgeon #2 performed orthopedic surgery for patient #5 on 7/19/16. Interview with the surgeon on 10/18/16 at 7:50 AM revealed the procedure required use of an instrument called a acetabulum reamer. He stated the instrument was brought to the OR as available for use, but upon inspection had "bone-like fragments." At that time the physician showed a picture to the 2 surveyors of the bone-like whitish fragments and instrument that had been prepared for use during surgery. During an interview on 10/17/16 at 3:15 PM the assistant CNO verified she was aware of the incident. She further stated the unclean instrument did not have contact with the patient, therefore this incident had not been reviewed or investigated to determine what steps had been omitted in the sterilization process.
c. Review of the medical record revealed surgeon #1 performed surgery for patient #6 on 9/13/16. This review revealed the surgeon placed a microlarygeal suction in the patient's throat and withdrew it due to malfunction. At that time an inspection of the interior areas of the instrument revealed dried bloody materials. Interview with certified surgery technician #1 on 10/17/16 at 3:10 PM revealed the instruments had been washed, cleaned, inspected, and stored in the clean instrument room on the Friday before the scheduled surgery on Tuesday. She further stated on Monday morning the instruments were packaged and sterilized without an additional inspection or cleaning. Review of the root cause analysis revealed the surgery sets were also not properly examined in the OR prior to use. Interview with the ICP and interim director of perioperative services on 10/24/16 at 2:55 PM revealed laboratory tests were completed to determine whether patient #1 had been negatively affected during exposure. They stated the laboratory results for the instrument were negative for hepatitis and human immunodeficiency virus.
d. Review of the assistant CNO's 10/19/16 documentation of the events that occurred after patient #7 was wheeled into the OR on 10/19/16 revealed the surgical field was prepared with contaminated instruments. Interview with surgeon #2 on 10/19/16 at 9:20 AM revealed he had scheduled the patient to undergo an arthroscopy that morning at 7:30 AM. The patient was under general anesthesia when the surgeon entered the OR suite, and at that time he and the OR staff found the instruments for the procedure were contaminated. Specifically, a trochar essential to the procedure had "bone-like fragments" that were whitish and reddened in color. During the interview the physician showed the picture to the 2 surveyors. When he insisted the instruments all be removed, he was informed that the only other instrument pack for the procedure was not available. The second instrument pack had to be sterilized using the immediate use sterilization process for timeliness, which caused a 34 minute delay in the procedure while the patient remained under general anesthesia. The surgeon further stated the hospital had only one full-time employee in the sterile processing department at the Lander location and one employee responsible for sterile processing was inadequate. The surgeon said he had stated this to administration in the past.

2. Interview on 10/19/16 at 9:45 AM with the Lander assistant CNO and the ICP confirmed the issues with sterile processing that surgeon #2 shared with the surveyors had occurred. The assistant CNO said she was not sure of the cause. She also stated the hospital had been attempting to hire another staff member in the sterile processing department at the Lander location without success, and that some travel staff with experience in that area sometimes helped out.

3. Review of the facility's sterilization procedure and standard based on the Association of periOperative Registered Nurses recommended practice titled "RP: Sterile Technique" revealed: VII.c. Breaks in sterile technique may expose the patient to increased microbial contamination. The risk for infection increases with increased amounts of microbial contamination. Preventing, observing for, recognizing, and taking immediate corrective action for breaks in sterile technique may prevent or reduce microbial contamination and help minimize the risk of surgical site infection. VII.d. If inorganic material (eg. blood, hair, tissue, bone fragments) or other debris (eg. bone cement, grease, mineral deposits) is found on an instrument or item in a sterile set, the entire set should be considered contaminated and perioperative team members should take corrective actions immediately. Organic and inorganic material that remains on a surgical instrument may be transferred to the surgical wound or other areas of the body, which increases the risk for surgical site infection or other postoperative complications.

Regarding safe injection practices:
1. According to the CDC recommendations for Safe Injection Practices, updated 2015, the septum of the medication vial and intravenous ports should be disinfected before piercing. Additional recommendations included vials should not be entered or re-entered with the same needle and syringe; even if the medication is for the same patient. Review of the 2016 inservice and education records showed this was the facility's standard of care, and education regarding this standard was provided for all the nurses and physicians. Review of the audit tool that was developed after the 5/5/16 validation survey showed anesthesiologists and certified registered nurse anesthetists (CRNA) were observed during medication administration in July, September and October 2016. Further review revealed 40% to 80% compliance for the anesthesiologists and 87% to 100% for the CRNAs. The following concerns were identified:
a. On 10/18/16 from 8:16 AM to 8:40 AM before and during the procedure for patient #8, anesthesiologist #1 was observed withdrawing and administering intravenous medications to the patient at the Lander location. The observation revealed the anesthesiologist did not consistently disinfect the septum on the medication vial prior to withdrawing medication into the syringe; nor did she disinfect the intravenous ports prior to administering each medication. Further observation revealed she withdrew and administered medications using the same syringe and needle two times.
b. Observation on 10/19/16 from 8:10 AM to 8:45 AM revealed anesthesiologist #2 administered intravenous medications before and during the surgical procedure for patient #9 at the Riverton location. The observation revealed the anesthesiologist did not consistently disinfect the septum on the medication vial prior to withdrawing medication into the syringe. Further observation revealed he removed and covered the intravenous port with the same intravenous cap after each injection.
c. Interview with the chief of surgery and anesthesia on 10/19/16 at 12:29 PM revealed the anesthesiologists did not consistently use safe injection practices because the expectations were not clear and it is a challenge to make changes in tasks that they had performed in the same manner for many years.

Regarding safe injection practices:
1. According to the CDC recommendations for Safe Injection Practices, updated 2015, the septum of the medication vial and intravenous ports should be disinfected before piercing. Additional recommendations included vials should not be entered or re-entered with the same needle and syringe; even if the medication is for the same patient. Review of the 2016 inservice and education records showed this was the facility's standard of care, and education regarding this standard was provided for all the nurses and physicians. Review of the audit tool that was developed after the 5/5/16 survey showed anesthesiologist and certified registered nurse anesthetists (CRNA) were observed during medication administration in July, September and October 2016. Further review revealed 40% to 80% compliance for the anesthesiologist and 87% to 100% for the CRNAs. The following concerns were identified:

a. On 10/18/16 from 8:16 AM to 8:40 AM before and during the procedure for patient #8, anesthesiologist #1 was observed withdrawing and administering intravenous medications to the patient at the Lander location. The observation revealed the anesthesiologist did not consistently disinfect the septum on the medication vial prior to withdrawing medication into the syringe; nor did she disinfect the intravenous ports prior to administering each medication. Further observation revealed she withdrew and administered medications using the same syringe and needle two times.
b. Observation on 10/19/16 from 8:10 AM to 8:45 AM revealed anesthesiologist #2 administered intravenous medications before and during the surgical procedure for patient #9 at the Riverton location. The observation revealed the anesthesiologist did not consistently disinfect the septum on the medication vial prior to withdrawing medication into the syringe. Further observation revealed he removed and covered the intravenous port with the same intravenous cap after each injection.
c. Interview with the chief of surgery and anesthesia on 10/19/16 at 12:29 PM revealed the anesthesiologists did not consistently use safe injection practices because the expectations were not clear and it is a challenge to make changes in tasks that they had performed in the same manner for many years.
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Based on staff interview and review of medical records, and root cause analysis reports, the facility failed to ensure resources related to adequate number of sterile processing personnel, and surgical instrument availability for scheduled surgeries were consistently provided to meet surgical service needs. This failure affected 4 of 4 sample patients (#4, #5, #6, #7) who were potentially exposed to contaminated surgical instruments due to lack of staff assigned sterile processing duties. In addition, 1 of 1 sample patient (#7) was anesthetized for 34 minutes prior to surgery because an appropriately cleaned and sterilized instrument tray was not readily available for use. The findings were:

1. Review of the medical record revealed surgeon #1 performed surgery for patient #4 on 6/3/16. Further review revealed the surgeon placed an instrument for suctioning in the surgery area and the instrument did not function properly due to clogged dried blood in the small lumens. A replacement instrument was checked prior to use and dried blood was found on this instrument too. A third instrument was used to complete the surgery. Review of the root cause analysis revealed the instruments were not properly cleaned and inspected.

2. Review of the medical record revealed surgeon #2 performed orthopedic surgery for patient #5 on 7/19/16. Interview with the surgeon on 10/18/16 at 7:50 AM revealed the procedure required use of an instrument called an acetabulum reamer. He stated the instrument was brought to the OR as available for use, but upon inspection had "bone-like fragments."

3. Review of the medical record revealed surgeon #1 performed surgery for patient #6 on 9/13/16. This review revealed the surgeon placed a microlarygeal suction in the patient's throat and withdrew it due to malfunction. At that time an inspection of the interior areas of the instrument revealed dried bloody materials. Interview with certified surgery technician #1 on 10/17/16 at 3:10 PM revealed the instruments had been washed, cleaned, inspected, and stored in the clean instrument room on the Friday before the scheduled surgery on Tuesday. She further stated on Monday morning the instruments were packaged and sterilized without an additional inspection or cleaning. Review of the root cause analysis revealed the surgery sets were not properly examined in the OR prior to use because one sterile processing staff was reassigned other duties before he was able to complete the process.

4. Review of the assistant CNO's 10/19/16 documentation of the events that occurred after patient #7 was wheeled into the OR on 10/19/16 revealed the surgical instrument table was prepared with contaminated instruments. Interview with surgeon #2 on 10/19/16 at 9:20 AM revealed he insisted that all instruments be removed and he was informed that the only other instrument pack for the procedure was not available. The second instrument pack had to be flash sterilized for timeliness, which caused a 34 minute delay in the procedure while the patient remained under general anesthesia. The surgeon stated the second instrument pack was not available because the hospital had only one full-time employee in the sterile processing department at the Lander location. He further stated that one employee responsible for sterile processing was inadequate and he had stated this to administration in the past.

5. Interview on 10/19/16 at 9:45 AM with the Lander assistant CNO and the ICP confirmed the issues with sterile processing that surgeon #2 shared with the surveyors had occurred. The assistant CNO said she was not sure of the cause. She also stated the hospital had been attempting to hire another staff member in the sterile processing department at the Lander location without success, and some travel staff with experience in that area sometimes helped out.

6. Interview on 10/28/16 at 8:30 AM with the interim director of peri-operative services revealed the facility's standard was to prepare instrument trays the night before a scheduled surgery and utilize "count sheets" to ensure all necessary instruments and items were available for surgery. She further stated this process required staff to ensure a back-up set was readily available for use, but this standard was not followed on 10/19/16 when the only available replacement instruments had not been sterilized. The interim director of peri-operative services also stated that a written policy and procedure that addressed ensuring necessary surgical instruments were available at the time of scheduled surgeries had not been developed.