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Based on interview and document review the hospital failed to provide a sanitary environment to avoid sources of infections and communicable diseases and to thoroughly investigate breakdowns in the active program for the prevention of infections for 4 of 20 patients reviewed who had surgery at the hospital with surgical instruments that were not sterilized.

The cumulative effect of these systems failures resulted in the hospital's inability to ensure adequate infection control in sterile processing.

Therefore the hospital was unable to meet the Condition of Participation of Infection Control at 42 CFR 482.42. These deficient practices had the potential to impact all patients receiving surgical services at the hospital. Findings Include:

See A-0749 - Based on interview and document review the hospital failed to develop a system for preventing infection and communicable disease for 4 of 20 patients, Patient 7 (P-7) P-8, P-9 and 1 of 6 (P-1, P-2, P-3, P-4, P-5, P-6) additional surgical patients who had surgery with unsterlized instruments; however, it was unable to be determined which one of these six patients had the unsterlized tray/instruments used during surgery. In addition the hospital failed to develop a system to investigate potential infections and communicable disease for surgery patients when debris was identified in sterile surgical trays.

Based on interview and document review the hospital failed to develop a system for preventing infection and communicable disease for 4 of 20 patients, Patient 7 (P-7) P-8, P-9 and 1 of 6 additional surgical patients who had surgery with unsterlized instruments; however, it was unable to be determined which one of these six patients (P-1, P-2, P-3, P-4, P-5, P-6) had the unsterlized tray/instruments used during surgery. In addition the hospital failed to develop a system to investigate potential infections and communicable disease for surgery patients when debris was identified in sterile surgical trays.

Finding include:

Medical record review revealed P-7 was admitted to the hospital on 9/11/2014 with diagnoses including cerebrospinal fluid leak and surgical intranasal repair. P-7 had surgery on 9/11/2014.

Medical record review revealed P-8 was admitted to the hospital on 9/11/2014 with diagnoses including chronic sinusitis and surgical revision, sinuscopy with fusion. P-8 had surgery on 9/11/2014.

Medical record review revealed P-9 was admitted to the hospital on 9/11/2014 for surgery for aortic valve replacement. P-9 had surgery on 9/11/2014.

Medical record review revealed P-1 was admitted to the hospital on 9/11/2014 for hysterectomy. P-1 had surgery on 9/11/2014.

Medical record review revealed P-2 was admitted to the hospital on 9/11/2014 for dilation and curettage, (D&C). P-2 had surgery on 9/11/2014.

Medical record review revealed P-3 was admitted to the hospital on 9/11/2014 for D&C. P-3 had surgery on 9/11/2014.

Medical record review revealed P-4 was admitted to the hospital on 9/11/2014 for surgery for uterine fibroid. P-4 had surgery on 9/11/2014.

Medical record review revealed P-5 was admitted to the hospital on 9/11/2014 for uterine myoma. P-5 had surgery on 9/11/2014.

Medical record review revealed P-6 was admitted to the hospital on 9/11/2014 for D&C. P-6 had surgery on 9/11/2014.

Registered Nurse (RN)-Y was interviewed on 9/29/14 at 10:15 a.m. and stated on 9/12/14 before the first case of the day at approximately 7:00 a.m. he visually scanned the instruments set up for the surgery that was about to start. While scanning the trays set up, he observed that a tray was set up for use, but the external sterility indicator had not changed color (darkening to a black color), indicating it had not been exposed to sterilization. RN-Y stated he removed the tray from the OR immediately and alerted the sterile processing department of the concern.

The internal investigation team including: Sterile Processing Manager F, (SPM-F), Quality Manager-D, (QM-D), Performance Improvement Director-E, (PID-E), RN Director of Surgery-G, (RN-G), Manager of Infection Control-H, (MIC-H), and Vice President of Operations-I, (VP-I) were interviewed on 9/23/14 at 8:45 a.m.

SPM-F stated he was notified on 9/12/14 at approximately 7:00 a.m. that an external sterilization indicator had not completed the chemical reaction (color change) indicating sterility, and it was in an operating room (OR) suite ready to be used for surgery. SPM-F stated he initiated an investigation and determined a load of 14 genesis pans (pans that hold surgical instruments before, during and after the sterilization process) had not completed the sterilization process before being released for use in surgery. SPM-F stated that although the pans had been decontaminated through thermal and enzymatic cleaning (Getinge Washer/Disinfector) late on 9/10/14, the sterilization step was omitted. SPM-F and RN-G stated that on 9/10/14 two sterilization loads were inaccurately labeled the same, sterilizer 1, load 10 (1:10), and one load labeled 1:10 was released without the sterilization process being completed. (The other load labeled 1:10 was processed per protocol for an outside entity and had been removed from the hospital.) Because two loads were labeled the same, staff, Sterile Processor -O, (SP-O), determined, in error, that the computer printout for sterilization of load 1:10 was for the load that had not been through the process, when it was actually for the load that had been removed from the hospital. SPM-F stated that 4 unsterlized trays were used in surgery on 9/11/2014 and 10 trays were recovered before use on patients. Staff members stated they were able to identify 3 of the patients the unsterlized trays were used on, while the 4th tray was used on 1 of 6 patients, but they were unable to identify which of the 6 patients the last tray was used for. SPM-F stated that employee, Sterile Processor -J, (SP-J) in the sterile processing department failed to follow procedure, had not processed the load through the autoclave and that the external indicator had not changed color, but staff released the load. OR staff (Surgical Technicians and/or Registered Nurse Circulating staff) in 4 cases did not follow procedure when the staff failed to validate sterility and observe that the external indicator had not changed color (indicating the trays had not been exposed to sterilization.) All patients potentially affected by this incident were notified of the incident by letter and phone communication immediately and follow-up testing for potential infections had been offered. No patients exhibited any signs of infection at the time of their discharge.

Sterile Processor -J, (SP-J) was interviewed on 9/24/2014 at 10:15 a.m. and stated she labeled load 1:10 on 9/10/2014 at approximately 10:30 p.m. to go into the autoclave and put it through the sterilization process. SP-J stated she labeled the next load (1:11), but did not put it through the autoclave because it was close to the end of her shift. She left it for the next shift to sterilize. SP-J had no explanation as to how 2 loads had the same labels on them, both inaccurately labeled 1:10 with no load 1:11 found.

Sterile Processor -O, (SP-O) was interviewed on 9/23/2014 at 12:50 p.m. and stated she came on shift at 11:00 p.m. on 9/10/2014 and found a sterilizer load labeled 1:10 in the autoclave. The previous Sterile Processor had left for the day and was not there to give her a report of what had been completed. In the computer load 1:10 had been processed through the autoclave and she was not aware 2 loads had been labeled 1:10. (Labeling 2 loads with the same number is not the policy of the department.) SP-O stated she pulled the load labeled 1:10 from the autoclave, put it in quarantine until the load 1:10's biological indicator had passed (a biological indicator is a device for monitoring the sterilization process which uses bacterial spores to demonstrate whether conditions were favorable to achieve sterilization), then she released the load labeled 1:10 for use in surgery. SP-O stated she did not observe that the external indicators had not changed color, (indicating the load had not been exposed to the sterilization process.) SP-O stated she was not aware another load labeled 1:10 had been processed in the department and released. When she looked in the sterilizer computer and saw load 1:10 had been sterilized, she printed the load page and put it with the load labeled 1:10 that she found when she came on shift.

A document titled sterilizer log, undated and provided by the hospital was reviewed. On the log was taped a sterilization integrator, (a strip of paper with an area that changes color when it is exposed to steam sterilization. An integrator is used with each load processed to differentiate between processed and unprocessed packages and trays.) The integrator labeled 1:11 (which is thought by staff members to have been from the second load labeled 1:10) clearly shows no color change (indicating no exposure to steam sterilization), while the 3 other strips taped to the log labeled 1:8, 1:9 and 1:10 revealed color change.

Surgical Technician-M (SM-M) was interviewed on 9/23/2014 at 11:35 a.m. and stated she was told that she used unsterile trays on a case on 9/11/2014. SM-M stated she did not recall seeing any indicators that were unchanged when she set-up her OR trays. SM-M stated sometimes other staff open the trays, so she was not sure who opened the trays on that case. SM-M stated the hospital is still having problems with instruments that have to be sent back to sterile processing after they are delivered to surgery, for example, recently (after 9/11/2014) the OR she was working in had to return 3 trays before one was delivered that they could use. One unusable tray had a suction tip that had not been loosened, one had no internal sterility indicator inside, and one had human tissue on an instrument. SM-M stated the OR does not always track which instruments are used in each case, so they do not always know which instruments are used on which patients.

Surgical Technician-N (ST-N) was interviewed on 9/23/2014 at 11:55 a.m. and stated she worked 9/11/2014. ST-N stated she was told she used unsterile instruments on 9/11/2014, but she could not recall seeing any unchanged external indicators. ST-N stated she usually visually checks the indicators, but did not specifically recall seeing them that day.

RN-K was interviewed on 9/23/2014 at 10:45 a.m. and stated she was working on 9/12/2014 and surgery was just about to get underway when she was notified she had an unsterlized tray in the OR. RN-K stated she had not noticed the external indicators had not changed color prior to being notified of the concern. RN-K stated they removed the equipment from the OR and obtained new equipment.

Dr.-R and Dr.-S, Infectious Disease Physicians, were interviewed on 9/24/2014 at 9:05 a.m. and stated that since the instruments in the second load labeled 1:10 had gone through the Washer/Disinfector cleaning before they were released, the risk of disease transmission was very small.

SPM-F was interviewed again on 9/25/2014 at 9:50 a.m. and stated that he was aware of a concern from 9/24/2014 when he was called to the OR to check 3 trays with residue found in them when they were opened in the OR. He stated he checked the trays and it appeared there was bone residue in the trays. The trays were removed from the OR because they were not considered sterile. SPM-F stated they were not sure if there were other trays with bone residue in them.

RN-X, Assistant Clinical Nurse Manager was interviewed on 9/25/2014 at 10:05 a.m. and stated the last few days 4 - 5 trays a day have been returned to sterile processing because of concerns about debris in the tray. RN-X stated they identified 3 trays yesterday (9/24/14) and 4 trays today (9/25/14) that had what appeared to be bone residue in them.

SPM-F was interviewed on 9/25/2014 at 1:05 p.m. and stated that there was no way to recall other instruments that were decontaminated together and by the same staff member or in the same washer as the trays with bone fragments because the hospital does not track who decontaminates the instruments.

RN-G, Director of Surgery was interviewed on 9/23/2014 at 12:40 p.m. and stated he was aware the hospital has been having concerns related to consistency and the frequency of concerns with sterile processing. RN-G stated staff members are trained to process sterile equipment at the hospital.

The document titled Getinge 8666 Washer-Disinfector, dated 4/28/2011 and provided by the hospital was reviewed. (This washer is the type of washer the trays are put through prior to sterilization. The second load labeled 1:10 had been processed through this washer, then missed the last step of sterilization.) The following was noted: This product is not a substitute for sterilization. Critical items such as invasive surgical instruments must be further processed by terminal sterilization before use in any procedure.

The policy titled Assembly and Preparation for Sterilization, with an approval date of 9/2011 and provided by the hospital was reviewed. Under the section titled Procedure: 5. Packaging,
i. A process monitoring device will be inside each package.
ii. An external chemical indicator is used with each load to differentiate processed and unprocessed packages and trays.
iii. All items and packages to be sterilized will be labeled with a lot control identifier consisting of: the sterilizer identification number, the date of sterilization, and the cycle/load number.

The policy titled Steam Sterilization Procedure, dated approved 9/2011 and provided by the hospital was reviewed. the following was noted:
Under section C. Load release
i. Load release is dependent on the results of the physical, chemical and biological monitoring results obtained at the conclusion of the sterilization cycle.
1. Loads containing Bl (biological) tests must be quarantined until the results of the Bl tests are known.
d. Sterilization failures
ii. Items from a malfunctioning load are considered non-sterile.
e. Sterilization recalls.
i. Initiate a product recall if items from sterilized loads have been released and later found to have questionable or failed monitoring results which may be due to mechanical malfunctioning or operator error.

A document titled Circulator role: Evaluation, undated and provided by the hospital was reviewed and the following was indicated:
Item 4: Open Room; verify sterility of supplies/instruments.

A document titled Scrub role: Evaluation, undated and provided by the hospital was reviewed and the following was indicated:
Item 2: Open OR Room; verify sterility of supplies/equipment.

The immediate jeopardy was removed on 9/30/2014 at 3:30 p.m. related to substantial implementation of an acceptable immediate jeopardy removal plan including: 1. Engaging an outside expert consulting firm to reprocess all instrument sets in the hospital inventory. 2. Add a four minute wash and drain phase to instrument and orthopedic wash cycles. 3. Revision of hospital policies to include inspection of all instrument trays for organic material and removal of trays identified. 4. Immediate implementation of procedure to eliminate duplicate sterilizer printouts. 5. Implementation of a second post-sterilization check of all sterilized loads. 6. Implementation of internal integrator verification of sterility in the OR before surgery is commenced. 7. Conduct a sweep of all surgical instrument sets to ensure all external indicators indicate sterilization has occurred. 8. Implementation of decontamination tracking. 9. Update policies for reporting of quality defects in surgical instrument trays. 10. Twice daily leader rounding to assess compliance with policies and procedures, address staff and physician concerns and conduct quality checks. Observations and interviews on 9/30/2014 revealed adequate implementation of the removal plan. Condition level noncompliance remained at the time of exit in the Conditions of Participation Infection Control at 42 CFR 482.42.

Based on interview and document review the hospital failed to provide surgical services that were in accordance with acceptable standards of practice for 4 of 20 patients reviewed who had surgery at the hospital with surgical instruments that were not sterilized.

The cumulative effect of these systems failures resulted in the hospital's inability to ensure adequate surgical services.

Therefore the hospital was unable to meet the Condition of Participation of Surgical Services at 42 CFR 482.51. These deficient practices had the potential to impact all patients receiving surgical services at the hospital. Findings Include:

See A- 0951 - Based on interview and document review the hospital failed to develop a system for providing surgical services in accordance with acceptable standards of practice for 4 of 20 patients, Patient 7 (P-7) , P-8, P-9 and 1 of 6 (P-1, P-2, P-3, P-4, P-5, P-6) additional surgical patients who had surgery with unsterlized instruments; however, it was unable to be determined which one of these six patients had the unsterlized tray/instruments used during surgery.

Based on interview and document review the hospital failed to provide surgical services consistent with needs and resources and designed to achieve and maintain high standards of medical practice and patient care for 4 of 20 patients, Patient 7 (P-7) , P-8, P-9 and 1 of 6 (P-1, P-2, P-3, P-4, P-5, P-6) additional surgical patients who had surgery with unsterlized instruments; however, it was unable to be determined which one of these six patients had the unsterlized tray/instruments used during surgery. The staff failed to verify the sterility of the instruments in the operating room suites.

Findings include:

Medical record review revealed P-7 was admitted to the hospital on 9/11/2014 with diagnoses including cerebrospinal fluid leak and surgical intranasal repair. P-7 had surgery on 9/11/2014.

Medical record review revealed P-8 was admitted to the hospital on 9/11/2014 with diagnoses including chronic sinusitis and surgical revision, sinuscopy with fusion. P-8 had surgery on 9/11/2014.

Medical record review revealed P-9 was admitted to the hospital on 9/11/2014 for surgery for aortic valve replacement. P-9 had surgery on 9/11/2014.

Medical record review revealed P-1 was admitted to the hospital on 9/11/2014 for hysterectomy. P-1 had surgery on 9/11/2014.

Medical record review revealed P-2 was admitted to the hospital on 9/11/2014 for dilation and curettage, (D&C). P-2 had surgery on 9/11/2014.

Medical record review revealed P-3 was admitted to the hospital on 9/11/2014 for D&C. P-3 had surgery on 9/11/2014.

Medical record review revealed P-4 was admitted to the hospital on 9/11/2014 for surgery for uterine fibroid. P-4 had surgery on 9/11/2014.

Medical record review revealed P-5 was admitted to the hospital on 9/11/2014 for uterine myoma. P-5 had surgery on 9/11/2014.

Medical record review revealed P-6 was admitted to the hospital on 9/11/2014 for D&C. P-6 had surgery on 9/11/2014.

Registered Nurse (RN)-Y was interviewed on 9/29/14 at 10:15 a.m. and stated on 9/12/14 at the first case of the day at approximately 7:00 a.m. he visually scanned the instruments set up for the surgery that was about to start. While scanning the trays set up, he observed that a tray was set up for use, but the external sterility indicator had not changed color, indicating it had not been exposed to sterilization. RN-Y stated he immediately removed the tray from the OR and alerted the sterile processing department of the concern.

Internal investigation team Sterile Processing Manager F, (SPM-F), Quality Manager-D, (QM-D), Performance Improvement Director-E, (PID-E), RN Director of Surgery-G, (RN-G), Manager of Infection Control-H, (MIC-H), and Vice President of Operations-I, (VP-I) were interviewed on 9/23/14 at 8:45 a.m. SPM-F stated he was notified on 9/12/14 at approximately 7:00 a.m. that an external sterilization indicator had not completed the chemical reaction (color change) indicating sterility, and it was in an operating room (OR) suite ready to be used for surgery. SPM-F stated he initiated an investigation and determined a load of 14 genesis pans (pans that hold surgical instruments before, during and after the sterilization process) had not completed the sterilization process before being released for use in surgery. SPM-F stated that although the pans had been decontaminated through thermal and enzymatic cleaning (Getinge Washer/Disinfector) late on 9/10/14, the sterilization step was omitted.

SPM-F and RN-G stated that on 9/10/14 two sterilization loads were inaccurately labeled the same, sterilizer 1, load 10 (1:10), and one load was released without the sterilization process being completed. Because two loads were labeled the same, staff, Sterile Processor -O, (SP-O), determined, in error, that the computer printout for sterilization of load 1:10 was for the load that had not been through the process, when it was actually for the load that had been removed from the hospital. SPM-F stated that 4 unsterlized trays were used on patients in surgery and 10 trays were recovered before use on other patients. SPM-F and RN-G stated they were able to identify 3 of the patients the unsterlized trays were used on, while the 4th tray was used on 1 of 6 patients, but they were unable to identify which of the 6 patients the tray was used for. SPM-F stated that staff in the sterile processing department failed to follow procedure, had not processed the load through the autoclave and that the external indicator had not changed color, but they released the load. OR staff, (Surgical Technicians and/or Registered Nurse Circulating staff), in 4 cases also did not follow procedure when they failed to follow that the external indicator had not changed color (indicating the trays had not been exposed to sterilization.) Staff in the OR are to verify equipment/instrument sterility by observing the color change on the external indicators before utilizing equipment. All patients potentially impacted by this incident had been notified of the incident and follow-up infectious disease testing had been offered. No patients exhibited any signs of infection at the time of their discharge.

A document titled sterilizer log, undated and provided by the hospital was reviewed. On the log was taped a sterilization integrator, (a strip of paper with an area that changes color when it is exposed to steam sterilization. An integrator is used with each load processed to differentiate between processed and unprocessed packages and trays.) The integrator labeled 1:11 (which is thought by staff members to have been from the second load labeled 1:10) clearly shows no color change (indicating no exposure to steam sterilization), while the 3 other strips taped to the log labeled 1:8, 1:9 and 1:10 revealed color change.

Surgical Technician-M (SM-M) was interviewed on 9/23/2014 at 11:35 a.m. and stated she was told that she used unsterile trays on a case on 9/11/2014. SM-M stated she did not recall seeing any indicators that were unchanged when she set-up her OR trays. SM-M stated sometimes other staff open the trays, so she was not sure who opened the trays on that case.

Surgical Technician-N (ST-N) was interviewed on 9/23/2014 at 11:55 a.m. and stated she worked 9/11/2014. ST-N stated she was told she used unsterile instruments on 9/11/2014, but she could not recall seeing any unchanged external indicators. ST-N stated she usually visually checks the indicators, but did not specifically recall seeing them that day.

RN-K was interviewed on 9/23/2014 at 10:45 a.m. and stated she was working on 9/12/2014 and surgery was just about to get underway when she was notified she had an unsterlized tray in the OR. RN-K stated she had not noticed the external indicators had not changed color prior to being notified of the concern. RN-K stated they removed the equipment from the OR and obtained new equipment.

The document titled Getinge 8666 Washer-Disinfector, dated 4/28/2011 and provided by the hospital was reviewed. (This washer is the type of washer the trays are put through prior to sterilization. The second load labeled 1:10 had been processed through this washer, then missed the last step of sterilization.) The following was noted: This product is not a substitute for sterilization. Critical items such as invasive surgical instruments must be further processed by terminal sterilization before use in any procedure.

The policy titled Assembly and Preparation for Sterilization, with an approval date of 9/2011 and provided by the hospital was reviewed. Under the section titled Procedure: 5. Packaging,
i. A process monitoring device will be inside each package.
ii. An external chemical indicator is used with each load to differentiate processed and unprocessed packages and trays.
iii. All items and packages to be sterilized will be labeled with a lot control identifier consisting of: the sterilizer identification number, the date of sterilization, and the cycle/load number.

The policy titled Steam Sterilization Procedure, dated approved 9/2011 and provided by the hospital was reviewed. the following was noted:
Under section C. Load release
i. Load release is dependent on the results of the physical, chemical and biological monitoring results obtained at the conclusion of the sterilization cycle.
1. Loads containing Bl (biological) tests must be quarantined until the results of the Bl tests are known.
d. Sterilization failures
ii. Items from a malfunctioning load are considered non-sterile.
e. Sterilization recalls.
i. Initiate a product recall if items from sterilized loads have been released and later found to have questionable or failed monitoring results which may be due to mechanical malfunctioning or operator error.

A document titled Circulator role: Evaluation, undated and provided by the hospital was reviewed and the following was indicated:
Item 4: Open Room; verify sterility of supplies/instruments.

A document titled Scrub role: Evaluation, undated and provided by the hospital was reviewed and the following was indicated:
Item 2: Open OR Room; verify sterility of supplies/equipment.

The immediate jeopardy was removed on 9/30/2014 at 3:30 p.m. related to substantial implementation of an acceptable immediate jeopardy removal plan including: 1. Engaging an outside expert consulting firm to reprocess all instrument sets in the hospital inventory. 2. Add a four minute wash and drain phase to instrument and orthopedic wash cycles. 3. Revision of hospital policies to include inspection of all instrument trays for organic material and removal of trays identified. 4. Immediate implementation of procedure to eliminate duplicate sterilizer printouts. 5. Implementation of a second post-sterilization check of all sterilized loads. 6. Implementation of internal integrator verification of sterility in the OR before surgery is commenced. 7. Conduct a sweep of all surgical instrument sets to ensure all external indicators indicate sterilization has occurred. 8. Implementation of decontamination tracking. 9. Update policies for reporting of quality defects in surgical instrument trays. 10. Twice daily leader rounding to assess compliance with policies and procedures, address staff and physician concerns and conduct quality checks. Observations and interviews on 9/30/2014 revealed adequate implementation of the removal plan. Condition level noncompliance remained at the time of exit in the Conditions of Participation Surgical Services at 42 CFR 482.51.