HospitalInspections.org

Based on hospital's rules and regulations, document review and interview, the hospital's Governing Body failed to ensure the Infection Control and Prevention Plan was reviewed and included uniform policies and procedures for the manual-cleaning, rinsing, drying and high-level disinfection of flexible difficult intubation scopes, failed to ensure employees were trained and had completed competencies in the Sterile Processing Department (SPD), and the hospital's Infection Control and Prevention observers failed to identify non-compliance in the monthly Tracer Observation Reports in the areas of biological indicators and annual competencies resulting in continuing failure to document biological indicator test results and failure to recognize, rectify and monitor the lack of training for the employees in the Sterile Processing Department.

Findings include:

The hospital's Rules & Regulations approved by the Medical Executive Committee (9/28/10), Medical Staff (10/28/10) and Governing Body (11/17/10), last revised 2/17/16, documented the following:

I. Infection Control / Prevention
1. The Medical Staff committees, through its chairpersons, practicing members, or Infection Control Practitioner, has the authority to institute any appropriate control measures...when it is reasonably felt that danger to patients, guests or personnel exists.

The hospital's leadership failed to take appropriate action when a reprocessing issue with flexible difficult intubation scopes was identified on 6/8/17.

There was a lack of documented evidence the Sterile Processing Technician's received training regarding the Karl Storz flexible difficult intubation scopes including conducting leak tests on the scopes. There was a lack of documented evidence the Sterile Processing Technician's received training on the Olympus flexible difficult intubation scopes.

The hospital started to reprocess the Olympus flexible difficult intubation scopes in the Sterrad (hydrogen peroxide vapor and low temperature gas plasma sterilization machine) without ensuring the scopes were validated for durability. There was no documentation the Sterile Processing Technicians received training regarding the other equipment and products used in the Sterile Processing Department.

2. C) Reviewing and evaluating all aseptic, isolation, sterilization, and sanitation techniques employed in the facility. Such techniques shall be defined in written policies and procedures.

The hospital's leadership failed to ensure there were policies and guidelines available for the manual cleaning and high-level disinfection process in the decontamination area of the Sterile Processing Department. There was a lack of standardization in the reprocessing of the flexible scopes. Managers and supervisors were unable to access the Sterile Processing Departments policies and procedures.

2. L) Consultations relative to the purchase of all equipment and supplies used for sterilization, disinfection, and decontamination purposes.

The hospital's leadership failed to ensure the Sterile Processing Department staff were provided education and training by the manufacturer's representatives on the sterilizers, high-level disinfection, scopes, cleaning products, biological indicators, and other equipment and supplies used in the Sterile Processing Department.

2. M) Periodic reviews of cleaning procedures, agents, and schedules in use throughout the facility, and consultation relative to any major change in cleaning products or techniques.

The hospital's leadership failed to ensure there was standardization in the manual cleaning process for flexible scopes in the Sterile Processing Department. There was no written policy for the high-level disinfection process specific to the devices processed in the Sterile Processing Department. The hospital did not consult with Sterrad or Olympus manufacturer's to ensure the Olympus scopes could have been reprocessed in the Sterrad and the correct cycle for sterilization.

1) The following interviews refer to the reprocessing of the flexible difficult intubation scopes. The facility used 3 scopes: 2 were Olympus brand and the third scope was a Karl Storz brand.

On 7/17/17 at 2:20 PM, a Sterile Processing Technician indicated the sterile processing area stopped performing leak tests (used to detect leaks in scopes to prevent or minimize the effects of fluid invasion) on the flexible difficult intubation scopes 2 months prior because the newer Sterile Processing Technicians were not performing them. The Sterile Processing Technician was unable to provide documentation leak tests were performed prior to the tests being stopped two months ago.

On 7/17/17 at 2:35 PM, a Sterile Processing Technician verbalized not knowing the cleaning solution to water ratio for the manual cleaning process. The technician did not receive training on the hospital's manual cleaning process or the high-level disinfection process and was told to reprocess leaking scopes if the pressure did not drop fast with a leak test. The Technician verbalized the pre-cleaner solution should not have been used instead of an enzymatic cleaner for the manual cleaning.

There was no patient tracking and no documentation of leak tests in the Sterile Processing Department. The Sterile Processing Department Clinical Supervisor informed the staff via text to begin using the Sterrad sterilization process instead of the high-level disinfection process after 06/08/17.

There was no specific training in the Sterile Processing Department with the exception of observing other Sterile Processing Technicians. There were no performance competencies completed.

On 7/18/17 at 9:30 AM, an Olympus representative indicated the instructions for use should have been followed and no steps should have been omitted. The Olympus leak tester should always be used with Olympus scopes, not manual testing. Reusing leaking scopes increased the infection risk for patients because contaminated fluid could remain in the leaking areas creating a pocket for bacteria. The hospital should have called Sterrad to see if Olympus scopes could have been reprocessed in the Sterrad.

On 7/18/17 at 9:55 AM, a Karl Storz representative verbalized the cleaning solution ratio was important to follow for manual cleaning. Technicians should not have been relying on manual leak tests. The training provided on 6/15/17, should have included leak testing. The representative recommended deflection (moving scope handle in both directions) during leak tests or else a leak could have been hidden. Karl Storz had no record of conducting training at the facility prior to June 15, 2017.

On 7/18/17 in the afternoon, the Process Improvement Manager indicated the Sterile Processing Department's Clinical Supervisor (SPDCS) was unable to provide training and in-service documentation for the Sterile Processing Technicians. The Sterile Processing Department's policies and guidelines were kept on the supervisor's department computer, and the computer could not be accessed to obtain the policies. The hospital discovered the reprocessing issues with flexible difficult intubation scopes on 6/8/17.

2) On 7/18/17 at 1:30 PM, a Sterile Processing Technician demonstrated the manual cleaning process for a flexible difficult intubation scope in the decontamination area of the Sterile Processing Department. The Sterile Processing Technician identified a pre-cleaner to be used for the manual cleaning instead of using an enzymatic cleaner.

The Operating Room Services Manager present during the demonstration read the label on the pre-cleaner and agreed it was not an enzymatic cleaner. The Operating Room Services Manager agreed the product was only a pre-cleaner used to wipe devices / scopes immediately after use in the Operating Room or procedure room.

3) On 7/18/17 in the afternoon, a Sterrad representative indicated the Olympus scopes should have been processed with the duo cycle (60 minutes) in the Sterrad NX100 and the advanced cycle for the Sterrad NX, but the Olympus scopes were not validated for durability in the Sterrad.

A Sterile Processing Technician indicated the hospital processed the flexible difficult intubation scopes in the NX100 with the flex cycle, (which was 18 minutes shorter than the duo cycle). The Sterile Processing Technician verbalized the hospital did not use the duo cycle on the NX100 model or the advanced cycle on the NX model. The Sterile Processing Department Clinical Supervisor directed the Sterile Processing Technicians to use the Sterrad for the flexible difficult intubation scopes onward from 6/9/17.

The Sterrad NX100 records showed the Olympus flexible difficult intubation scopes were processed on June 9, 14, 15, 19, 27 and 29. On June 29, 2017, all loads were processed with the standard cycle, not the flex cycle for Olympus as the Sterile Processing Technician indicated was the process.

4) A Sterile Processing Technician acknowledged the Sterrad's biological indicators were not being read properly or at all. In many cases, the cultures overlapped shifts, and the following shift did not check or document the results.

On 7/18/17 in the afternoon, the Process Improvement Manager and Infection Prevention Manager indicated monthly tracers were completed with each targeted area of the hospital. Corporate dictated the quality tracer questions utilized. The same questions were asked monthly for the past year in the Sterile Processing Department. The Sterile Processing Department did not perform any quality improvement projects within the department.

The Infection Prevention Manager provided the hospital's Infection Prevention and Control Plan for 2017, which placed a high priority on a surveillance plan in the Sterile Processing Department. Planned action for 2017 in the Sterile Processing Department included, continuing monthly / quarterly tracers with follow-up on non-compliant findings in areas that complete high-level disinfection or sterilization. Tracers included evaluation of documentation and process, transportation, and competency completion.

Sterile Processing Department Tracer Observation Reports were reviewed for the past 12 months (July 2016 through June 2017):

The past 12 months showed 100% compliance with completed biological indicator test logs with the proper information recorded for each run (question 15).

A random review of May 1-21, 2017 logs revealed the Sterile Processing Department did not record some biological indicator test results on May 1, 5, 7, 10, 14 (none recorded), 15, 17 and 21. A Sterile Processing Technician acknowledged the gaps in the log.

The Infection Control and Prevention Employees documented the Sterile Processing Department Tracer Observation Detail Report with 100% compliance for question 15 for every month in the past year. Question 15 was the completion of biological test indicator logs with the proper information recorded.

On 7/19/17 in the morning, the Process Improvement Manager acknowledged question 15 referred to the biological indicator test logs of the Sterrad processors, but the tracer reviewers were not certified sterile processing technicians.

A random review of the 07/11/17 log revealed the biological indicator test results were missing for Sterrad 100, 102 and 103.

5) Question 19 of the monthly Tracer Observation Report asked if the Sterile Processing Department employees completed annual competencies.

From July through December 2016, March 2017, April 2017 and June 2017, the Infection Prevention Observers indicated selected employees completed annual competencies in the Sterile Processing Department for those Tracer Observation Detail Reports.

On 07/19/17 in the afternoon, the Human Resources Director and the Operating Room Services Manager indicated competencies and training could have been in the human resources file or the Sterile Processing Department file. Both sets of files were obtained, and all Sterile Processing Technician files were reviewed for orientation, annual competencies and training in the Sterile Processing Department. The Human Resources Director, Operating Room Services Manager and Process Improvement Manager were all present during the review.

The Sterile Processing Department Clinical Supervisor had a competency based orientation document dated 1/28/13. The document was a self-assessment and not co-signed by an evaluator. The Sterile Processing Department Clinical Supervisor had Storz flexible endoscope training dated 6/15/17. There was no other documentation in the file regarding annual competencies or training with equipment or products used in the Sterile Processing Department.

The current Operating Room Services Manager, hired November 2016, lacked documented evidence of any competencies.

A Sterile Processing Technician assigned to evaluate the other Sterile Processing Technicians in July 2017 was hired on 6/22/15. The Sterile Processing Department Clinical Supervisor evaluated this technician for an annual competency on 3/8/16 and Sterrad training on 10/27/16. There was no documentation of a return demonstration verification. The Sterile Processing Technician completed a self assessment for the clinical orientation competency checklist and the annual competency checklist for the Sterile Processing Department, which were not co-signed by an evaluator.

A Sterile Processing Technician hired 1/24/00 had an annual competency checklist dated 5/10/13 and had Storz flexible endoscope training dated 6/15/17.

A Sterile Processing Technician hired 3/10/14 had a clinical orientation competency checklist dated 3/8/16. Received Sterrad training on 10/27/16, there was no documentation of return demonstration verification. Received Storz flexible endoscope training dated 6/15/17, had a clinical orientation competency checklist dated 7/11/17 and an annual competency checklist dated 7/11/17. The clinical orientation competency checklist was not co-signed by an evaluator.

A Sterile Processing Technician hired 11/17/14 had a clinical orientation competency checklist dated 3/8/16. The clinical orientation competency checklist was not co-signed by an evaluator. Received Sterrad training on 10/27/16, there was no documentation of return demonstration verification. Received Storz flexible endoscope training dated 6/15/17, had a clinical orientation competency checklist dated 7/12/17 and an annual competency checklist dated 6/12/17. These competency checklists were co-signed by another Sterile Processing Technician.

A Sterile Processing Technician hired 7/18/16 had Sterrad training on 10/27/16, there was no documentation of return demonstration verification. Received Storz flexible endoscope training dated 6/15/17, had a clinical orientation competency checklist dated 7/12/17 and an annual competency checklist dated 7/11/17.

A Sterile Processing Technician hired 8/8/16 had Sterrad training on 10/27/16, there was no documentation of a return demonstration verification. Received Storz flexible endoscope training dated 6/15/17, had a clinical orientation competency checklist and annual competency checklist dated 7/11/17.

A Sterile Processing Technician hired 10/3/16 had an annual competency checklist dated 3/1/17. There was no self assessment by the Sterile Processing Technician or performance level assessed by the evaluator. Received Storz flexible endoscope training dated 6/15/17, had a clinical orientation competency checklist and annual competency checklist dated 7/8/17. The evaluator signed 7/12/17.

A Sterile Processing Technician hired 10/10/16 had Sterrad training on 10/27/16, there was no documentation of return demonstration verification. Received Storz flexible endoscope training dated 6/15/17, had a clinical orientation competency checklist and annual competency checklist dated 7/8/17. The evaluator signed 7/12/17.

A Sterile Processing Technician hired 4/17/17 had Storz flexible endoscope training dated 6/15/17. The Technician had a clinical orientation competency checklist dated 7/10/17. The evaluator signed the document on 7/12/17. The Technician had an annual competency checklist dated 7/11/17, which was not due for another 9 months.

Within the hospital's Infection Prevention and Control Annual Plan for 2017 was a 9-page competency checklist for Karl Storz flexible scopes. On 6/15/17, the training provided by a Karl Storz representative omitted pages 1-4 which covered the equipment, bedside pre-cleaning and the leakage test. The documented training only covered manual cleaning/detergent cleaning, water rinsing, drying and inspection.

The Competency Assessment policy (HR218 revised 1/1/16) revealed
it is the responsibility of facility administration and leadership to ensure each facility employee is competent in skills, knowledge, and ability required and safe / effective use of equipment as appropriate to the job description. The competency program included the following components: Credentials and Documents: skill record, core and unit competencies, and educational records. Yearly competency assessment included core competencies and unit/department competencies, which addressed, but were not limited to patient population, age-specific skills, use of equipment, acceptable performance of new procedures, and high risk/problem prone tasks and skills, which required validation of performance.

The Human Resources Employee Records policy (HR103 revised 2/18/13) revealed the human resources department would be responsible for maintaining employment records. The policy lacked documented evidence anyone was responsible for checking whether competencies were due for employees.

Based on observation, interview, document review and record review, the hospital failed to demonstrate the Quality Assessment and Performance Improvement (QAPI) Program's involvement with identified issues regarding the cleaning of flexible difficult intubation scopes and the accuracy of the data provided to the QAPI program by the previous Supervisor of the Sterile Processing Department (SPD). The identified issues included inappropriate high-level disinfection of flexible difficult intubation scopes, inappropriate sterilization of scopes and surgical instruments, safety concerns regarding proper cleaning and maintenance in the Sterile Processing Department, non-compliance with policy changes, and Sterile Processing Technicians without competency evaluations were identified without the knowledge of the hospital staff including the QAPI department. The hospital failed to ensure the Quality Assessment and Performance Improvement program identified and monitored the safety of services in the Sterile Processing Department (Tag A0283).

The cumulative effect of these systemic practices resulted in the failure of the facility to deliver statutorily mandated safe care to its patients.

Based on observation, interview, record review and document review, the hospital's Quality Assessment Performance Improvement (QAPI) program failed to identify and monitor problem prone areas in the Sterile Processing Department (SPD) in regards to improper high- level disinfection of flexible difficult intubation scopes, improper sterilization of surgical instruments, lack of policies and procedures, lack of reviewing current policies and procedures and following current policies and procedures, incomplete staff competencies, equipment sterilization logs with missing documentation and testing information, and the hospital's Infection Control and Prevention observers failing to identify non-compliance in the monthly Tracer Observation Reports in the areas of biological indicators and annual competencies resulting in continuing failure to document biological indicator test results and failure to recognize, rectify and monitor the lack of training of the employees in the Sterile Processing Department.

Findings include:

There was no quality assessment process to confirm all Sterile Processing Technicians received and demonstrated proper cleaning of flexible difficult intubation scopes. There were no quality assessment checks to determine what approved cleaning processes were to be used for the scopes such as approved cleaning solutions and leak testing procedures.

The following examples 1 and 2 were identified:

1) The following interviews refer to the reprocessing of flexible difficult intubation scopes. The facility used 3 scopes: 2 were Olympus brand and the third scope was a Karl Storz brand.

On 7/17/17 at 2:20 PM, a Sterile Processing Technician indicated the sterile processing area stopped performing leak tests on the flexible difficult intubation scopes 2 months prior because the newer Sterile Processing Technicians were not performing them. The Sterile Processing Technician was unable to provide documentation leak tests were performed prior to the tests being stopped two months ago.

On 7/17/17 at 2:35 PM, a Sterile Processing Technician verbalized not knowing the cleaning solution to water ratio for the manual cleaning process. The Technician verbalized the pre-cleaner solution should not have been used instead of an enzymatic cleaner for the manual cleaning. The technician did not receive training on the hospital's manual cleaning process or the high-level disinfection process and was told to reprocess leaking scopes if the pressure did not drop fast with a leak test.

There was no specific training in the Sterile Processing Department with the exception of observing other Sterile Processing Technicians. There were no performance competencies completed. There was no patient tracking and no documentation of leak tests in the Sterile Processing Department.

The Sterile Processing Department Clinical supervisor informed the staff via text to begin using the Sterrad sterilization process instead of the high-level disinfection process after 06/08/17.

On 7/18/17 at 9:30 AM, an Olympus representative indicated the instructions for use should have been followed and no steps should have been omitted. The Olympus leak tester should always be used with Olympus scopes, not manual testing. Reusing leaking scopes increased the infection risk for patients because contaminated fluid could remain in the leaking areas creating a pocket for bacteria. The hospital should have called Sterrad to see if Olympus scopes could be processed in Sterrad.

On 7/18/17 at 9:55 AM, a Karl Storz representative verbalized the cleaning ratio was important to follow for manual cleaning. Technicians should not have been relying on manual leak tests. The training provided on 6/15/17, should have included leak testing. The representative recommended deflection (moving scope handle in both directions) during leak tests or else a leak could have been hidden. Karl Storz had no record of conducting training at the facility prior to June 15, 2017.

On 7/18/17 in the afternoon, the Process Improvement Manager indicated the Sterile Processing Department's Clinical Supervisor (SPDCS) was unable to provide training and in-service documentation for the Sterile Processing Technicians. Sterile Processing Department policies and guidelines were kept on the supervisor's department computer, and the computer could not be accessed to obtain the policies. The facility discovered the reprocessing issues with flexible difficult intubation scopes on 6/8/17.

2) On 7/18/17 at 1:30 PM, a Sterile Processing Technician demonstrated the manual cleaning process for a flexible difficult intubation scope in the decontamination area. The Sterile Processing Technician identified a pre-cleaner to be used for the manual cleaning instead of using an enzymatic cleaner.

The Operating Room Services Manager present during the demonstration read the label on the pre-cleaner and agreed it was not an enzymatic cleaner. The Operating Room Services Manager agreed the product was only a pre-cleaner used to wipe devices/scopes immediately after use in the Operating Room or procedure room.

There was no quality assessment process implemented to determine if manufacturer's instructions were reviewed to determine if specific sterilizing machines could be used to clean specific devices such as the flexible difficult intubation scopes.

The following example 3 was identified:

3) On 7/18/17 in the afternoon, a Sterrad representative indicated the Olympus scopes should have been processed with the duo cycle (60 minutes) in the Sterrad NX100 and the advanced cycle for the Sterrad NX, but the Olympus scopes were not validated for durability in the Sterrad.

A Sterile Processing Technician indicated the facility processed the flexible difficult intubation scopes in the NX100 with the flex cycle, (which was 18 minutes shorter than the duo cycle). The Sterile Processing Technician verbalized the facility did not use the duo cycle on the NX100 model or the advanced cycle on the NX model. The Sterile Processing Department Clinical Supervisor directed the Sterile Processing Technicians to use the Sterrad for the flexible difficult intubation scopes onward from 6/9/17.

The Sterrad NX100 records showed the Olympus flexible difficult intubation scopes were processed on June 9, 14, 15, 19, 27 and 29. On June 29, 2017, all loads were processed with the standard cycle, not the flex cycle for Olympus as the Sterile Processing Technician indicated was the process.

There was no documented evidence a quality assessment process was implemented to visually identify if staff were complying with proper procedures and documentation regarding biological indicator testing. The facility's one question verbal process identified 100% compliance but was contradicted by what was identified through visual observation and documented facility policies.

The following examples 4 and 5 were identified:

4) A Sterile Processing Technician acknowledged the Sterrad's biological indicators were not being read properly or at all. In many cases, the cultures overlapped shifts, and the following shift did not check or document the results.

On 7/18/17 in the afternoon, the Process Improvement Manager and Infection Prevention Manager indicated monthly tracers were completed with each targeted area of the hospital. Corporate dictated the quality tracer questions utilized. The same questions were asked monthly for the past year in the Sterile Processing Department. The Sterile Processing Department did not perform any quality improvement projects within the department.

The Infection Prevention Manager provided the hospital's Infection Prevention and Control Plan for 2017, which placed a high priority on a surveillance plan in the Sterile Processing Department. The Planned action for 2017 in the Sterile Processing Department included, continuing monthly/quarterly tracers with follow-up on non-compliant findings in areas that complete high-level disinfection or sterilization. Tracers included evaluation of documentation and process, transportation, and competency completion.

The Sterile Processing Department Tracer Observation Reports were reviewed for the past 12 months (July 2016 through June 2017):

The past 12 months showed 100% compliance with completed biological indicator test logs with the proper information recorded for each run (question 15).

A random review of May 1-21, 2017 logs revealed the Sterile Processing Department did not record some biological indicator test results on May 1, 5, 7, 10, 14 (none recorded), 15, 17 and 21. The Sterile Processing Technician acknowledged the gaps in the log.

The Infection Control and Prevention Employees documented the Sterile Processing Department Tracer Observation Detail Report with 100% compliance for question 15 for every month in the past year. Question 15 was the completion of biological test indicator logs with the proper information recorded.

On 7/19/17 in the morning, the Process Improvement Manager acknowledged question 15 referred to the biological indicator test logs of the Sterrad processors, but the tracer reviewers were not certified sterile processing technicians.

A random review of the 07/11/17 log revealed the biological indicator test results were missing for Sterrad 100, 102 and 103.

5) The facility policy number SS-156, titled Sterilization and High-Level Disinfection in Surgical Services and with the last revised date of 3/2012, documented Gas Plasma Sterilizer (Sterrad) a. Run Cycle Sure biological monitor with first load every day; b. Document all information in logbook; c. Record reading of biological monitor at 24-hours and then at 48-hours.

On 7/17/17 in the afternoon, in the Sterile Processing Department, 4-hour biological indicators were incubating in the incubator device. The Director of Nursing for Surgical Services and the Sterile Processing Department staff indicated the 4-hour biological indicators were used for the Sterrad machines.

On 7/18/17 in the morning, the Director of Nursing for Surgical Services indicated there were four Sterrad sterilizers in the Sterile Processing Department. Three regular sized ones and a mini one. The sterilizers were numbered from 00, 101, 102 and 103.

The record keeping log form only had a section to document the 4-hour biological indicator result. There were no sections to document a 24-hour or 48-hour result.

On 7/11/17, a 4-hour biological indicator test was performed on sterilizer 00. There were no 4-hour, 24-hour and 48-hour results documented.

On 7/11/17, a 4-hour biological test was performed on sterilizer 102. There were no 4-hour, 24-hour and 48-hour results documented.

On 7/11/17, a 4-hour biological test was performed on sterilizer 103. There were no 4-hour, 24-hour and 48-hour results documented.

On 7/14/17, a 4-hour biological test was performed on sterilizer 103. There were no 24-hour and 48-hour results documented.

On 7/17/17 in the afternoon, a Sterile Processing Technician indicated the staff used to perform biological checks on the Sterrad with 24-hour biological indicators 6 months ago and had not documented 48-hour results while using the 24-hour biological indicators. The Sterile Processing technician indicated they switched to the 4-hour biological indicators from the 24-hour indicators but were still not monitoring and documenting 24-hour and 48-hour results.

On 7/18/17 in the afternoon, the Director of Nursing for Surgical Services confirmed staff had not always been documenting results for the 4-hour biological indicator when it was performed. The Director of Nursing for Surgical Services confirmed the staff had not been performing the 24-hours and the 48-hour checks for the biological indicators and was not aware of the process in the facility policy.

There was no quality assessment process to track and determine if initial and annual staff competencies were being performed and whether hospital policies were reviewed and followed regarding competencies and return demonstrations.

The following examples 6 and 7 were identified:

6) Question 19 of the monthly Tracer Observation Report asked if the Sterile Processing Department employees completed annual competencies.

From July through December 2016, March 2017, April 2017 and June 2017, the Infection Prevention Observers indicated selected employees completed annual competencies in the Sterile Processing Department for those Tracer Observation Detail Reports.

On 07/19/17 in the afternoon, the Human Resources Director and the Operating Room Services Manager indicated competencies and training could have been located in the human resources file or the Sterile Processing Department file. Both sets of files were obtained, and all Sterile Processing Technician files were reviewed for orientation, annual competencies and training in the Sterile Processing Department. The Human Resources Director, Operating Room Services Manager and Process Improvement Manager were all present during the review.

The Sterile Processing Department Clinical Supervisor had a competency based orientation document dated 1/28/13. The document was a self-assessment and not co-signed by an evaluator. The Sterile Processing Department Clinical Supervisor had received Storz flexible endoscope training dated 6/15/17. There was no other documentation in the file regarding annual competencies or training with equipment or products used in the Sterile Processing Department.

The current Operating Room Services Manager, hired November 2016, lacked documented evidence of any competencies.

A Sterile Processing Technician assigned to evaluate the other Sterile Processing Technicians in July 2017 was hired on 6/22/15. The Sterile Processing Department Clinical Supervisor evaluated this technician for an annual competency on 3/8/16 and Sterrad training on 10/27/16. There was no documentation of a return demonstration verification. In July 2017, the Sterile Processing Technician completed a self assessment for the clinical orientation competency checklist and the annual competency checklist for the Sterile Processing Department, which were not co-signed by an evaluator.

A Sterile Processing Technician hired 1/24/00 had an annual competency checklist dated 5/10/13 and had received Storz flexible endoscope training dated 6/15/17.

A Sterile Processing Technician hired 3/10/14 had a clinical orientation competency checklist dated 3/8/16. Received Sterrad training on 10/27/16, there was no documentation of return demonstration verification. Received Storz flexible endoscope training dated 6/15/17, had a clinical orientation competency checklist dated 7/11/17 and an annual competency checklist dated 7/11/17. The clinical orientation competency checklist was not co-signed by an evaluator.

A Sterile Processing Technician hired 11/17/14 had a clinical orientation competency checklist dated 3/8/16. The clinical orientation competency checklist was not co-signed by an evaluator. Received Sterrad training on 10/27/16, there was no documentation of return demonstration verification. Received Storz flexible endoscope training dated 6/15/17, had a clinical orientation competency checklist dated 7/12/17 and an annual competency checklist dated 6/12/17. These competency checklists were co-signed by another Sterile Processing Technician.

A Sterile Processing Technician hired 7/18/16 had Sterrad training on 10/27/16, there was no documentation of return demonstration verification. Received Storz flexible endoscope training dated 6/15/17, had a clinical orientation competency checklist dated 7/12/17 and an annual competency checklist dated 7/11/17.

A Sterile Processing Technician hired 8/8/16 had Sterrad training on 10/27/16, there was no documentation of a return demonstration verification. Received Storz flexible endoscope training dated 6/15/17, had a clinical orientation competency checklist and annual competency checklist dated 7/11/17.

A Sterile Processing Technician hired 10/3/16 had an annual competency checklist dated 3/1/17. There was no self assessment by the Sterile Processing Technician or performance level assessed by the evaluator. Received Storz flexible endoscope training dated 6/15/17, had a clinical orientation competency checklist and annual competency checklist dated 7/8/17. The evaluator signed 7/12/17.

A Sterile Processing Technician hired 10/10/16 had Sterrad training on 10/27/16, there was no documentation of return demonstration verification. Received Storz flexible endoscope training dated 6/15/17, had a clinical orientation competency checklist and annual competency checklist dated 7/8/17. The evaluator signed 7/12/17.

A Sterile Processing Technician hired 4/17/17 had Storz flexible endoscope training dated 6/15/17. The Technician had a clinical orientation competency checklist dated 7/10/17. The evaluator signed the document on 7/12/17. The Technician had an annual competency checklist dated 7/11/17, which was not due for another 9 months.

Within the hospital's Infection Prevention and Control Annual Plan for 2017 was a 9-page competency checklist for the Karl Storz flexible scopes. On 6/15/17, the training provided by a Karl Storz representative omitted pages 1-4 which covered the equipment, bedside pre-cleaning and the leakage test. The documented training only covered manual cleaning/detergent cleaning, water rinsing, drying and inspection.

The Competency Assessment policy (HR218 revised 1/1/16) revealed it is the responsibility of facility administration and leadership to ensure each facility employee is competent in skills, knowledge, and ability required and safe/effective use of equipment as appropriate to the job description. The competency program included the following components: Credentials and Documents: skill record, core and unit competencies, educational records. Yearly competency assessment included core competencies and unit/department competencies, which addressed, but were not limited to patient population, age-specific skills, use of equipment, acceptable performance of new procedures, and high risk/problem prone tasks and skills, which required validation of performance.

The Human Resources Employee Records policy (HR103 revised 2/18/13) revealed the human resources department would be responsible for maintaining employment records. The policy lacked documented evidence anyone was responsible for checking whether competencies were due for employees.

7) The facility policy number SS-141 titled Recommended Practices of Selection and Use of Packaging Systems for Sterilization with the last revised date of 3/2016, documented personnel are to demonstrate competency in the use of sterilization packaging systems and accessories. Clinical Supervisors will periodically assess the competency of personnel by visually assessing abilities and practice annually.

On 7/19/17 in the afternoon, competencies could not be located for all the Sterile Processing Department staff.

On 7/19/17 in the afternoon, a Sterile Processing Technician indicated there was no trainer or supervisor conducting observation and return demonstration on competencies. The Sterile Processing Technician indicated the previous supervisor had not conducted return demonstration verification. The Sterile Processing Technician indicated the trainer conducting recent competencies on all Sterile Processing Department staff had not performed return demonstration processes.

On 7/19/17 in the afternoon, the Performance Improvement (PI) Manager, Manager of Surgery and Director of Nursing for Surgical Services indicated they were not aware return demonstrations were not being performed when assessing the Sterile Processing Department staff members' competencies.


22489

There were no quality assessment processes followed for reviewing, approving and implementing policies regarding recommended practices for sterilization.

The following example 8 was identified:

8) The facility policy number SS-141 titled Recommended Practices of Selection and Use of Packaging Systems for Sterilization with the last revised date of 3/2016, documented all Avionic products that are steamed for sterilization must follow manufacturer's IFUs (instructions for use) which had been updated for 2016 with 6 minute sterilization time and a 55 minute dry time for both the SI & XI models.

On 7/18/17 at 10:30 AM, a Sterile Processing Technician indicated to sterilize a DaVinci instrument it would go through cycle 4 in the sterilization machine. Cycle 4 was preset at 4-minute sterilization process, 50-minute dry time and a temperature setting of 270 degrees Fahrenheit. The preset cycle 4 did not coincide with the DaVinci instrument settings documented in the policy.

On 7/18/17 in the morning, the Director of Nursing for Surgical Services and two Sterile Processing Technicians were unaware of the hospital's policy regarding specific sterilization requirements for DaVinci products. The Sterile Processing Technicians confirmed there were no preset cycles in the sterilization machine that matched the policy setting used for DaVinci products of 6 minute and 55 minutes.

On 7/18/17 in the morning, the Director of Nursing for Surgical Services indicated DaVinci instruments were used for about 100 surgical procedures a month.

On 7/18/17 in the morning, a Sterile Processing Technician attempted to obtain information on sterilization requirements for DaVinci instruments in the One Source computerized reference data base. The Sterile Processing Technician attempted several times with no available results. The Director of Nursing for Surgical Services intervened and indicated One Source did not have information for DaVinci products due to the company was not willing to submit product information to One Source. The Director indicated several other instrument companies were not willing to submit their information to One Source. The Director confirmed One Source data base for staff to obtain specific sterilization requirements was not complete and lacked information on several surgical instruments.

On 7/18/17 in the morning, a Sterile Processing Technician attempted to locate instructions for DaVinci products on line. Instructions were found but the instructions were written in Chinese. A resource Manual was located in the office of the previous Supervisor of the Sterile Processing Department. The manufacturer's instructions were from 2014, and the facility did not have current instructions or a reference on the policy as to why the specifications were changed for 2016.

On 7/18/17 in the afternoon, the local DaVinci representative was not able to confirm if the facility policy regarding the sterilization settings for DaVinci were correct. The local representative referred the regional representative. The regional representative contacted the facility and indicated there was no such recommendation to have sterilization settings set at 6-minute sterilization time and 55 minute dry time. The regional representative was unaware of any memo changes on the setting and requested if there was a reference on the facility policy on where they obtained the information.

There was no reference on why the sterilization process for DaVinci instruments was changed in the 2016 facility policy SS-141. The DON for Surgical Services, the Infection Control Coordinator and the Quality department staff relied on the previous Supervisor for Sterile Processing Department to have reviewed the policy but could not verify why an Administrative specialist did not review and approve the policy changes after the Supervisor of Sterile Processing Department.

Based on observation, interview, record review and document review, the hospital's leadership failed to ensure the Sterile Processing Department staff received training on the proper cleaning, high-level disinfection, and sterilization procedures for surgical instruments processed in the Sterile Processing Department.

Findings include:

1) The hospital used 3 flexible difficult intubation scopes: 2 were Olympus brand and the third scope was a Karl Storz brand.

On 7/17/17 at 2:20 PM, a Sterile Processing Technician indicated the sterile processing area stopped performing leak tests on the flexible difficult intubation scopes 2 months prior because the newer Sterile Processing Technicians were not performing them. The Sterile Processing Technician was unable to provide documentation leak tests were performed prior to the tests being stopped two months ago.

On 7/17/17 at 2:35 PM, a Sterile Processing Technician verbalized not knowing the cleaning solution to water ratio for the manual cleaning process. The Technician verbalized the pre-cleaner solution should not have been used instead of an enzymatic cleaner for the manual cleaning. The technician did not receive training on the hospital's manual cleaning process or the high-level disinfection process and was told to reprocess leaking scopes if the pressure did not drop fast with a leak test.

There was no specific training in the Sterile Processing Department with the exception of observing other Sterile Processing Technicians. There were no performance competencies completed. There was no patient tracking and no documentation of leak tests in the Sterile Processing Department.

The Sterile Processing Department Clinical supervisor informed the staff via text to begin using the Sterrad sterilization process instead of the high-level disinfection process after 06/08/17.

On 7/18/17 at 9:30 AM, an Olympus representative indicated the instructions for use should have been followed and no steps should have been omitted. The Olympus leak tester should always be used with Olympus scopes, not manual testing. Reusing leaking scopes increased the infection risk for patients because contaminated fluid could remain in the leaking areas creating a pocket for bacteria. The hospital should have called Sterrad to see if Olympus scopes could be processed in Sterrad.

On 7/18/17 at 9:55 AM, a Karl Storz representative verbalized the cleaning ratio was important to follow for manual cleaning. Technicians should not have been relying on manual leak tests. The training provided on 6/15/17, should have included leak testing. The representative recommended deflection (moving scope handle in both directions) during leak tests or else a leak could have been hidden. Karl Storz had no record of conducting training at the facility prior to June 15, 2017.

On 7/18/17 in the afternoon, the Process Improvement Manager indicated the Sterile Processing Department's Clinical Supervisor (SPDCS) was unable to provide training and in-service documentation for the Sterile Processing Technicians. Sterile Processing Department policies and guidelines were kept on the supervisor's department computer, and the computer could not be accessed to obtain the policies. The facility discovered the reprocessing issues with flexible difficult intubation scopes on 6/8/17.

2) On 7/18/17 at 1:30 PM, a Sterile Processing Technician demonstrated the manual cleaning process for a flexible difficult intubation scope in the decontamination area. The Sterile Processing Technician identified a pre-cleaner to be used for the manual cleaning instead of using an enzymatic cleaner.

The Operating Room Services Manager present during the demonstration read the label on the pre-cleaner and agreed it was not an enzymatic cleaner. The Operating Room Services Manager agreed the product was only a pre-cleaner used to wipe devices/scopes immediately after use in the Operating Room or procedure room.

3) On 7/18/17 in the afternoon, a Sterrad representative indicated the Olympus scopes should have been processed with the duo cycle (60 minutes) in the Sterrad NX100 and the advanced cycle for the Sterrad NX, but the Olympus scopes were not validated for durability in the Sterrad.

A Sterile Processing Technician indicated the facility processed the flexible difficult intubation scopes in the NX100 with the flex cycle, (which was 18 minutes shorter than the duo cycle). The Sterile Processing Technician verbalized the facility did not use the duo cycle on the NX100 model or the advanced cycle on the NX model. The Sterile Processing Department Clinical Supervisor directed the Sterile Processing Technicians to use the Sterrad for the flexible difficult intubation scopes onward from 6/9/17.

The Sterrad NX100 records showed the Olympus flexible difficult intubation scopes were processed on June 9, 14, 15, 19, 27 and 29. On June 29, 2017, all loads were processed with the standard cycle, not the flex cycle for Olympus as the Sterile Processing Technician indicated was the process.

4) The Sterile Processing Tech acknowledged the Sterrad's biological indicators were not being read properly or at all. In many cases, the cultures overlapped shifts, and the following shift did not check or document the results.

5) On 7/18/17 in the afternoon, the Process Improvement Manager and Infection Prevention Manager indicated monthly tracers were completed with each targeted area of the hospital. Corporate dictated the quality tracer questions utilized. The same questions were asked monthly for the past year in the Sterile Processing Department. The Sterile Processing Department did not perform any quality improvement projects within the department.

The Infection Prevention Manager provided the hospital's Infection Prevention and Control Plan for 2017, which placed a high priority on a surveillance plan in the Sterile Processing Department. The planned action for 2017 in the Sterile Processing Department included, continuing monthly/quarterly tracers with follow-up on non-compliant findings in areas that complete high-level disinfection or sterilization. Tracers included evaluation of documentation and process, transportation, and competency completion.

Sterile Processing Department Tracer Observation Reports were reviewed for the past 12 months (July 2016 through June 2017):

The past 12 months showed 100% compliance with completed biological indicator test logs with the proper information recorded for each run (question 15).

A random review of May 1-21, 2017 logs revealed the Sterile Processing Department did not record some biological indicator test results on May 1, 5, 7, 10, 14 (none recorded), 15, 17 and 21. The Sterile Processing Technician acknowledged the gaps in the log.

The Infection Control and Prevention Employees documented the Sterile Processing Department Tracer Observation Detail Report with 100% compliance for question 15 for every month in the past year. Question 15 was the completion of biological test indicator logs with the proper information recorded. On 7/19/17 in the morning, the Process Improvement Manager acknowledged question 15 referred to the biological indicator test logs of the Sterrad processors, but the tracer reviewers were not certified sterile processing technicians.

A random review of the 07/11/17 log revealed the biological indicator test results were missing for Sterrad 100, 102 and 103.

6) Question 19 of the monthly Tracer Observation Report asked if the Sterile Processing Department employees completed annual competencies.

From July through December 2016, March 2017, April 2017 and June 2017, the Infection Prevention Observers indicated selected employees completed annual competencies in the Sterile Processing Department for those Tracer Observation Detail Reports.

On 07/19/17 in the afternoon, the Human Resources Director and the Operating Room Services Manager indicated competencies and training could have been kept in the human resources file or the Sterile Processing Department file. Both sets of files were obtained, and all Sterile Processing Technician files were reviewed for orientation, annual competencies and training in the Sterile Processing Department. The Human Resources Director, Operating Room Services Manager and Process Improvement Manager were all present during the review.

The Sterile Processing Department Clinical Supervisor had a competency based orientation document dated 1/28/13. The document was a self-assessment and not co-signed by an evaluator. The Sterile Processing Department Clinical Supervisor had received Storz flexible endoscope training dated 6/15/17. There was no other documentation in the file regarding annual competencies or training with equipment or products in the Sterile Processing Department.

The current Operating Room Services Manager, hired November 2016, lacked documented evidence of any competencies.

A Sterile Processing Technician assigned to evaluate the other Sterile Processing Technicians in July 2017 was hired on 6/22/15. The Sterile Processing Department Clinical Supervisor evaluated this technician for an annual competency on 3/8/16 and Sterrad training on 10/27/16. There was no documentation of a return demonstration verification. In July 2017, the Sterile Processing Technician completed a self assessment for the clinical orientation competency checklist and the annual competency checklist for the Sterile Processing Department, which were not co-signed by an evaluator.

A Sterile Processing Technician hired 1/24/00 had an annual competency checklist dated 5/10/13 and had received Storz flexible endoscope training dated 6/15/17.

A Sterile Processing Technician hired 3/10/14 had a clinical orientation competency checklist dated 3/8/16. Received Sterrad training on 10/27/16, there was no documentation of return demonstration verification. Received Storz flexible endoscope training dated 6/15/17, had a clinical orientation competency checklist dated 7/11/17 and an annual competency checklist dated 7/11/17. The clinical orientation competency checklist was not co-signed by an evaluator.

A Sterile Processing Technician hired 11/17/14 had a clinical orientation competency checklist dated 3/8/16. The clinical orientation competency checklist was not co-signed by an evaluator. Received Sterrad training on 10/27/16, there was no documentation of return demonstration verification. Received Storz flexible endoscope training dated 6/15/17, had a clinical orientation competency checklist dated 7/12/17 and an annual competency checklist dated 6/12/17. These competency checklists were co-signed by another Sterile Processing Technician.

A Sterile Processing Technician hired 7/18/16 had Sterrad training on 10/27/16, there was no documentation of return demonstration verification. Received Storz flexible endoscope training dated 6/15/17, had a clinical orientation competency checklist dated 7/12/17 and an annual competency checklist dated 7/11/17.

A Sterile Processing Technician hired 8/8/16 had Sterrad training on 10/27/16, there was no documentation of a return demonstration verification. Received Storz flexible endoscope training dated 6/15/17, had a clinical orientation competency checklist and annual competency checklist dated 7/11/17.

A Sterile Processing Technician hired 10/3/16 had an annual competency checklist dated 3/1/17. There was no self assessment by the Sterile Processing Technician or performance level assessed by the evaluator. Received Storz flexible endoscope training dated 6/15/17, had a clinical orientation competency checklist and annual competency checklist dated 7/8/17. The evaluator signed 7/12/17.

A Sterile Processing Technician hired 10/10/16 had Sterrad training on 10/27/16, there was no documentation of return demonstration verification. Received Storz flexible endoscope training dated 6/15/17, had a clinical orientation competency checklist and annual competency checklist dated 7/8/17. The evaluator signed 7/12/17.

A Sterile Processing Technician hired 4/17/17 had Storz flexible endoscope training dated 6/15/17. The Technician had a clinical orientation competency checklist dated 7/10/17. The evaluator signed the document on 7/12/17. The Technician had an annual competency checklist dated 7/11/17, which was not due for another 9 months.

Within the hospital's Infection Prevention and Control Annual Plan for 2017 was a 9-page competency checklist for the Karl Storz flexible scopes. On 6/15/17, the training provided by a Karl Storz representative omitted pages 1-4 which covered the equipment, bedside pre-cleaning and the leakage test. The documented training only covered manual cleaning/detergent cleaning, water rinsing, drying and inspection.

The Competency Assessment policy (HR218 revised 1/1/16) revealed it is the responsibility of facility administration and leadership to ensure each facility employee is competent in skills, knowledge, and ability required and safe/effective use of equipment as appropriate to the job description. The competency program included the following components: Credentials and Documents: skill record, core and unit competencies, educational records. Yearly competency assessment included core competencies and unit/department competencies, which addressed, but were not limited to patient population, age-specific skills, use of equipment, acceptable performance of new procedures, and high risk/problem prone tasks and skills, which required validation of performance.

The Human Resources Employee Records policy (HR103 revised 2/18/13) revealed the human resources department would be responsible for maintaining employment records. The policy lacked documented evidence anyone was responsible for checking whether competencies were due for employees.


22489

7) On 7/17/17 and 7/18/17, in the Sterile Processing Department, work stations had small drawers and containers filled with steam chemical integrator strips. The chemical indicator strips were placed inside individually packaged surgical instruments or tray sets with multiple surgical instruments. The chemical indicators were used to determine whether the sterilization process conditions were met inside each pack or tray set.

The containers and drawers were replenished with new strips when the amount decreased. The manufactures bag had an expiration date for the strips. The individual strips themselves did not have an expiration date. When the containers or drawers were replenished from a new bag, the new strips were taken out of the bag and mixed with the old strips. There was no process to identify which strips were expired when the old and new strips were mixed together.

On 7/18/17 in the morning, the Director of Nursing (DON) for Surgical Services confirmed the new indicator strips were being mixed with possible expired chemical indicator strips.

8) On 7/17/17 in the morning, in the decontamination room, a Sterile Processing Technician was presoaking and cleaning surgical instruments prior to transferring the instruments to the next room for sterilization. The presoak enzymatic cleaner used to clean and soak the instruments was Prolystica. The Prolystica solution was dispensed from an automatic dispenser directly connected to the container. When the automatic dispenser button was pushed a set amount of the cleaner was dispensed into the sink filled with water. The product representative verbalized in front of the Sterile Processing Department staff, the Director of Nursing for Surgical Services and other administrative staff, the automatic dispenser dispensed 2 1/2 ounces into the tub. The representative indicated the enzymatic solution should be mixed with 10 gallons of water. There were no posted instructions on how many times to press the dispenser button, the amount the dispenser dispensed and the amount of water the solution should be mixed into. No one objected to the representative's instructions.

The bin where water was filled and the solution dispensed into had a very faint etched marking on the inside of the tub which read, "8." The Sterile Processing Department staff and the Director of Nursing for Surgical Services indicated the faint etching was the water filling marking point for 10 gallons.

The Prolystica manufacturer instructions documented the mixture range 1/40 - 1/10 ounces of Prolystica with one gallon of water.

Using the amount, the representative verbalized at 2 1/2 ounces of solution with 10 gallons of water, the concentration was not within the manufacturer's instructions and was too concentrated.

On 7/17/17 in the afternoon, in the decontamination area, a SPD Technician indicated 2 ounces of Prolystica solution was dispensed from the machine into the tub which was filled with 8 gallons of water. The Director of Nursing for Surgical Services confirmed the representative was incorrect with the information provided in the morning and Sterile Processing Department staff had tested the amount dispensed from the dispenser at 2 ounces per push of the button. The Director of Nursing for Surgical Services indicated the etched "8" represented 8 gallons and not 10 gallons and the 2.0 ounces of Prolystica was mixed with 8 gallons of water.

Using the amount, the Director of Nursing for Surgical Services verbalized at 2.0 ounces of solution with 8 gallons of water, the concentration was not within the manufacturer's instructions and was too concentrated. The highly concentrated ratio could damage the instruments.

On 7/17/17 in the afternoon, the Director of Nursing for Surgical Services and the Manager for the surgery department confirmed both mixtures of 2 1/2 ounces of Prolystica to 10 gallons and 2.0 ounces of Prolystica to 8 gallons did not comply to the manufacturer's instructions and the mixture was too concentrated.

9) The facility policy number SS-156, titled Sterilization and High-Level Disinfection in Surgical Services and with the last revised date of 3/2012, documented Gas Plasma Sterilizer (Sterrad) a. Run Cycle Sure biological monitor with first load every day; b. Document all information in logbook; c. Record reading of biological monitor at 24-hours and then at 48-hours.

On 7/17/17 in the afternoon, in the Sterile Processing Department, the 4-hour biological indicators were incubating in the incubator device. The Director of Nursing for Surgical Services and the Sterile Processing Department staff indicated 4-hour biological indicators were used for the Sterrad machines.

On 7/18/17 in the morning, the Director of Nursing for Surgical Services indicated there were four Sterrad sterilizers in the Sterile Processing Department. Three regular sized ones and a mini one. The sterilizers were numbered from 00, 101, 102 and 103.

The record keeping log form only had a section to document a 4-hour biological indicator result. There were no sections to document a 24-hour or 48-hour result.

On 7/11/17, a 4-hour biological indicator test was performed on sterilizer 00. There were no 4-hour, 24-hour and 48-hour results documented.

On 7/11/17, a 4-hour biological test was performed on sterilizer 102. There were no 4-hour, 24-hour and 48-hour results documented.

On 7/11/17, a 4-hour biological test was performed on sterilizer 103. There were no 4-hour, 24-hour and 48-hour results documented.

On 7/14/17, a 4-hour biological test was performed on sterilizer 103. There were no 24-hour and 48-hour results documented.

On 7/17/17 in the afternoon, a Sterile Processomg Technician indicated the staff used to perform biological checks on the Sterrad with 24-hour biological indicators 6 months ago and had not documented 48-hour results while using the 24-hour biological indicators. The Sterile Processing Technician indicated they switched to 4-hour biological indicators from 24-hour indicators but were still not monitoring and documenting 24-hour and 48-hour results.

On 7/18/17 in the afternoon, the Director of Nursing for Surgical Services confirmed staff had not always been documenting results for the 4-hour biological indicator when it was performed. The Director of Nursing for Surgical Services confirmed the staff had not been performing 24-hour and 48-hour checks for the biological indicators and was not aware of the process in the facility policy.

10) There were 8 Steris Sterilizer machines located through-out the Sterile Processing Department and the operating room (OR) area. Sterilizer #1 and #2 were in the SPD area. Sterilizers #3 to #8 were in the OR unit between operating rooms. Machine #8 was located in-between operating rooms 11 and 12. Machine #7 was located between rooms 9 and 10. Machine #6 was located inside room 6. Machine #5 was located in-between rooms 7 and 8. Machine #4 was located in-between rooms 3 and 4. Machine #3 was located in-between rooms 1 and 2.

A sticker, 1.5 x 2.5 centimeters, was produced by the Sterile Processing Department staff which documented which machine was used (#1 to #8), which load was performed and the date. The stickers were placed in a Steam Sterilizer Record Keeping book. The Director of Nursing for Surgical Services indicated the machine number was placed on the top left corner of the sticker. The load number was placed on the top right corner of the sticker.

After reviewing two record keeping books it was difficult to determine which machine was used and the load that was sterilized. The staff had documented some machine numbers on the upper right side where the load number was supposed to be documented and the load number was being placed on the upper left side where the machine number was supposed to be. The Director of Nursing for Surgical Services confirmed the staff had been educated regarding this issue but were still not following the correct process since the stickers reviewed had been dated from 7/13/17 to 7/16/17, and were still being documented incorrectly making it difficult to track the machine and loads.

11) There were 8 Steris Sterilizer machines located through-out the Sterile Processing Department and the operating room (OR) area. Each machine had a log book which was located next to the machine in their areas. In each log book was an 8 x 11.5-inch paper documenting in large letters, in bold black and with exclamation points:

"You must put a patient sticker on the flash sterilization record. What is being flashed. Cycle number. MD (medical doctor) name. Sign it! This is Mandatory! NO EXCEPTIONS!"

Machine #4 was located in-between rooms 3 and 4. The log book documented on 7/17/17, the load number 1 and 2 which included the diagnostic Bowie Dick test and the biological test. Load 3 and 4 did not identify what was being sterilized and the names of the patients.

Machine #5 was located in-between rooms 7 and 8. The log book form dated 7/17/17, did not document the physician name, the name of the patient and the signature of the staff who performed the sterilization process for load 3. Load 4 did not document the patient name and physician name.

Machine #8 was located in-between rooms 11 and 12. The log book form dated 7/17/17, did not document the physician name and the name of the patient.

On 7/17/17 in the afternoon, the Director of Nursing for Surgical Services indicated the log forms were incomplete and the Sterile Processing Department continued not to follow the directions posted in the log book. The Director of Nursing for Surgical Services indicated the purpose of the documentation was to track the names of the patient and sterilized items in case the staff obtained abnormal diagnostic and biological tests results the next day.

12) On 7/18/17 in the afternoon, a Registered Nurse (RN) indicated post-operative (post-op) phone calls were conducted with-in 24 hours after discharge to the patient's home. Three phone call attempts were made to contact the patient or family. The reason for post-op phone calls was to identify if any complications occurred or infection control issues arose such as fever or abnormal drainage from wounds.

Ten out of thirty patient records reviewed revealed no post-op/follow up phone calls were attempted.

On 7/18/17 in the afternoon, the RN Clinical Supervisor confirmed the following patients had no post-op phone call attempts to identify any infection control issues or complications from the procedures:

Patient #11, #15, #17, #18, #19, #20, #22, #23, #29 and #30

13) The facility policy number SS-141 titled Recommended Practices of Selection and Use of Packaging Systems for Sterilization with the last revised date of 3/2016, documented all DaVinci products that are steamed for sterilization must follow manufacturer's IFUs (instructions for use) which had been updated for 2016 with 6 minute sterilization time and a 55 minute dry time for both the SI & XI models.

On 7/18/17 at 10:30 AM, a Sterile ProcessingTechnician indicated to sterilize a DaVinci instrument it would go through cycle 4 in the sterilization machine. Cycle 4 was preset at 4-minute sterilization process, 50-minute dry time and a temperature setting of 270 degrees Fahrenheit. The preset cycle 4 did not coincide with the DaVinci instrument settings documented in the policy.

On 7/18/17 in the morning, the Director of Nursing for Surgical Services and two Sterile Processing Technicians were unaware of the facility's policy regarding specific sterilization requirements for DaVinci products. The Sterile Processing Department staff confirmed there were no preset cycles in the sterilization machine that matched the policy setting used for DaVinci products of 6 minute and 55 minutes.

On 7/18/17 in the morning, the Director of Nursing for Surgical Services indicated DaVinci instruments were used for about 100 surgical procedures a month.

On 7/18/17 in the morning, a Sterile Processing Technician attempted to obtain information on sterilization requirements for DaVinci instruments in the One Source computerized reference data base. The Sterile Processing Technician attempted several times with no available results. The Director of Nursing for Surgical Services intervened and indicated One Source did not have information for DaVinci products due to the company was not willing to submit product information to One Source. The Director indicated several other instrument companies were not willing to submit their information to One Source also. The Director confirmed One Source data base for staff to obtain specific sterilization requirements was not complete and lacked information on several surgical instruments.

On 7/18/17 in the morning, the Sterile Processing Technician attempted to locate instructions for DaVinci products on line. Instructions were found but the instructions were written in Chinese. A resource Manual was located in the office of the previous Supervisor of the Sterile Processing Department. The manufacturer's instructions were from 2014, and the facility did not have current instructions or a reference on the policy to why the specifications were changed for 2016.

On 7/18/17 in the afternoon, the local DaVinci representative was not able to confirm if the facility policy regarding the sterilization settings for DaVinci were correct. The local representative referred the regional representative. After three hours, the regional representative contacted the facility and indicated there was no such recommendation to have sterilization settings set at 6-minute sterilization time and 55 minute dry time. The regional representative was unaware of any memo changes on the setting and requested if there was a reference on the facility policy on where they obtained the information.

There was no reference on why the sterilization process for DaVinci instruments was changed in the 2016 facility policy SS-141. The Director of Nursing for Surgical Services, the Infection Control Coordinator and the Quality department staff relied on the previous Supervisor for Sterile Processing Department to have reviewed the policy but could not verify why an Administrative specialist did not review and approve the policy changes after the Supervisor of Sterile Processing Department.

14) On 7/17/17 in the morning, the Director of Nursing for Surgical Services indicated there was no reference sheet on what sterilization settings should be used for different tray sets. Tray sets were made up containers which held several different surgical instruments used for specific surgeries such as thoracic, cardiac and tracheotomy trays. Some trays were made up for surgeons preferred instruments. The Director indicated there was no need to have a reference resource for already made up tray sets due to the Sterile Processing Department staff were able to identify what instruments were in the sets and what settings were to be used.

On 7/18/17, in the afternoon the sterile log book was reviewed. A Summerlin Steam Sterilizer Log form dated 7/16/17, documented individual surgical instruments and tray sets that were loaded into sterilizer machine #2. The following instruments were documented on the form and went through the sterilization process in machine #2:

--7 Kerrisons
--1 Taylor retractor
--1 Minor Basic Tray
--1 Pediatric Laparotomy Tray
--7 Dav PP (sic)
--Vaginal Tray
--6 Currettes

A print out from sterilizer machine #2 was produced after the sterilization process of the above trays and instruments. The print out documented the instruments and trays were sterilized on 7/16/17 and did not identify which Sterile Processing staff initiated the sterilization process. The operator section of the print out was left blank. The print out documented the sterilization time of 6 minutes was performed with a 40-minute dry time.

The Director of Nursing for Surgical Services confirmed the preset cycles in machine #2 did not have a setting of 6 minutes and 40-minute dry time and the operator must have over rode the settings.

On 7/18/17 in the afternoon, a Sterile Procesing Technician was shown the same Summerlin Steam Sterilizer Log form dated 7/16/17, with the documented items from above. Without looking at the sterilizing print out, the SPD technician #1 indicated the trays loaded should have been sterilized on cycle #4 in machine #2. The preset cycle #4 in machine #2 was set at 4-minute sterilization time and 50-minute dry time which conflicted on the print out on what the load had already gone through.

On 7/18/17 in the afternoon, the Director of Nursing for Surgical Services confirmed cycle #4 on machine #2 was preset at 4-minute sterilization time and 50-minute dry time.

On 7/18/17 in the afternoon, another Sterile Processing Technician was shown the same Summerlin Steam Sterilizer Log form dated 7/16/17, with the documented items from above. Without looking at the sterilization print out, the Technician indicated the trays that were loaded should have been sterilized on cycle #4 in machine #2. The Technician glanced at the documented trays on the log and confirmed the sterilization cycle #4 on machine #2 was needed and indicated the preset cycle #4 was set at 6-minute sterilization time and 50-minute dry time. This information contradicted what the load had been sterilized at. The load had been sterilized at 6-minute sterilization time and 40-minute dry time.

On 7/18/17 in the afternoon, the Director of Nursing for Surgical Services confirmed the actual load that was sterilized on an over ride setting of 6 minute sterilization time and 40 minute dry time was different from what two other Sterile Processing Department staff thought the load should have been sterilized at. The Director indicated a tray set reference resource would have been useful to identify what the tray sets should have been sterilized at.

15) The facility policy number SS-141 titled Recommended Practices of Selection and Use of Packaging Systems for Sterilization with the last revised date of 3/2016, documented personnel are to demonstrate competency in the use of sterilization packaging systems and accessories. Clinical Supervisors will periodically assess the competency of personnel by visually assessing abilities and practice annually.

On 7/19/17 in the afternoon, competencies could not be located for all the SPD staff.

On 7/19/17 in the afternoon, a SPD technician indicated there was no trainer or supervisor conducting observation and return demonstration on competencies. The SPD technician indicated she had never seen the previous supervisor conduct return demonstration on other staff. The SPD technician indicated the trainer conducting recent competencies on all SPD staff had not performed return demonstration processes.

On 7/19/17 in t

Based on observation, interview, record review and document review, the hospital's leadership failed to ensure Sterile Processing Department staff received training on the proper cleaning, high-level disinfection, and sterilization procedures for surgical instruments processed in the Sterile Processing Department and failed to follow the Infection Control and Prevention plan for 2017.

Findings include:

1) The hospital used 3 flexible difficult intubation scopes: two were Olympus brand and the third scope was a Karl Storz brand.

On 7/17/17 at 2:20 PM, a Sterile Processing Technician indicated the sterile processing area stopped performing leak tests on the flexible difficult intubation scopes 2 months prior because the newer Sterile Processing Technicians were not performing them. The Sterile Processing Technician was unable to provide documentation leak tests were performed prior to the tests being stopped two months ago.

On 7/17/17 at 2:35 PM, a Sterile Processing Technician verbalized not knowing the cleaning solution to water ratio for the manual cleaning process. The Technician verbalized the pre-cleaner solution should not have been used instead of an enzymatic cleaner for the manual cleaning. The technician did not receive training on the hospital's manual cleaning process or the high-level disinfection process and was told to reprocess leaking scopes if the pressure did not drop fast with a leak test.

There was no specific training in the Sterile Processing Department except for observing other Sterile Processing Technicians. There were no performance competencies completed. There was no patient tracking and no documentation of leak tests in the Sterile Processing Department.

The Sterile Processing Department Clinical supervisor informed the staff via text to begin using the Sterrad sterilization process instead of the high-level disinfection process after 06/08/17.

On 7/18/17 at 9:30 AM, an Olympus representative indicated the instructions for use should have been followed and no steps should have been omitted. The Olympus leak tester should always be used with Olympus scopes, not manual testing. Reusing leaking scopes increased the infection risk for patients because contaminated fluid could have remained in the leaking areas creating a pocket for bacteria. The hospital should have called Sterrad to see if Olympus scopes could be processed in Sterrad.

On 7/18/17 at 9:55 AM, a Karl Storz representative verbalized the cleaning ratio was important to follow for manual cleaning. Technicians should not have been relying on manual leak tests. The training provided on 6/15/17, should have included leak testing. The representative recommended deflection (moving scope handle in both directions) during leak tests or else a leak could have been hidden. Karl Storz had no record of conducting training at the facility prior to June 15, 2017.

On 7/18/17 in the afternoon, the Process Improvement Manager indicated the Sterile Processing Department's Clinical Supervisor (SPDCS) was unable to provide training and in-service documentation for the Sterile Processing Technicians. Sterile Processing Department policies and guidelines were kept on the supervisor's department computer, and the computer could not be accessed to obtain the policies. The facility discovered the reprocessing issues with flexible difficult intubation scopes on 6/8/17.

2) On 7/18/17 at 1:30 PM, a Sterile Processing Technician demonstrated the manual cleaning process for a flexible difficult intubation scope in the decontamination area. The Sterile Processing Technician identified a pre-cleaner to be used for the manual cleaning instead of using an enzymatic cleaner.

The Operating Room Services Manager present during the demonstration read the label on the pre-cleaner and agreed it was not an enzymatic cleaner. The Operating Room Services Manager agreed the product was only a pre-cleaner used to wipe devices/scopes immediately after use in the Operating Room or procedure room.

3) On 7/18/17 in the afternoon, a Sterrad representative indicated the Olympus scopes should have been processed with the duo cycle (60 minutes) in the Sterrad NX100 and the advanced cycle for the Sterrad NX, but the Olympus scopes were not validated for durability in the Sterrad.

A Sterile Processing Technician indicated the facility processed the flexible difficult intubation scopes in the NX100 with the flex cycle, (which was 18 minutes shorter than the duo cycle). The Sterile Processing Technician verbalized the facility did not use the duo cycle on the NX100 model or the advanced cycle on the NX model. The Sterile Processing Department Clinical Supervisor directed the Sterile Processing Technicians to use the Sterrad for the flexible difficult intubation scopes onward from 6/9/17.

The Sterrad NX100 records showed the Olympus flexible difficult intubation scopes were processed on June 9, 14, 15, 19, 27 and 29. On June 29, 2017, all loads were processed with the standard cycle, not the flex cycle for Olympus as the Sterile Processing Technician indicated was the process.

4) The Sterile Processing Technician acknowledged the Sterrad's biological indicators were not being read properly or at all. In many cases, the cultures overlapped shifts, and the following shift did not check or document the results.

5) On 7/18/17 in the afternoon, the Process Improvement Manager and Infection Prevention Manager indicated monthly tracers were completed with each targeted area of the hospital. Corporate dictated the quality tracer questions utilized. The same questions were asked monthly for the past year in the Sterile Processing Department. The Sterile Processing Department did not perform any quality improvement projects within the department.

The Infection Prevention Manager provided the hospital's Infection Prevention and Control Plan for 2017, which placed a high priority on a surveillance plan in the Sterile Processing Department. Planned action for 2017 in the Sterile Processing Department included, continuing monthly/quarterly tracers with follow-up on non-compliant findings in areas that complete high-level disinfection or sterilization. Tracers included evaluation of documentation and process, transportation, and competency completion.

Sterile Processing Department Tracer Observation Reports were reviewed for the past 12 months (July 2016 through June 2017):

The past 12 months showed 100% compliance with completed biological indicator test logs with the proper information recorded for each run (question 15).

A random review of May 1-21, 2017 logs revealed the Sterile Processing Department did not record some biological indicator test results on May 1, 5, 7, 10, 14 (none recorded), 15, 17 and 21. The Sterile Processing Technician acknowledged the gaps in the log.

Infection Control and Prevention Employees documented the Sterile Processing Department Tracer Observation Detail Report with 100% compliance for question 15 for every month in the past year. Question 15 was the completion of biological test indicator logs with the proper information recorded. On 7/19/17 in the morning, the Process Improvement Manager acknowledged question 15 referred to the biological indicator test logs of the Sterrad processors, but the tracer reviewers were not certified sterile processing technicians.

A random review of the 07/11/17 log revealed the biological indicator test results were missing for Sterrad 100, 102 and 103.

6) Question 19 of the monthly Tracer Observation Report asked if the Sterile Processing Department employees completed annual competencies.

From July through December 2016, March 2017, April 2017 and June 2017, the Infection Prevention Observers indicated selected employees completed annual competencies in the Sterile Processing Department for those Tracer Observation Detail Reports.

On 07/19/17 in the afternoon, the Human Resources Director and the Operating Room Services Manager indicated competencies and training could have been kept in the human resources file or the Sterile Processing Department file. Both sets of files were obtained, and all Sterile Processing Technician files were reviewed for orientation, annual competencies and training in the Sterile Processing Department. The Human Resources Director, Operating Room Services Manager and Process Improvement Manager were all present during the review.

The Sterile Processing Department Clinical Supervisor had a competency based orientation document dated 1/28/13. The document was a self-assessment and not co-signed by an evaluator. The Sterile Processing Department Clinical Supervisor had received Storz flexible endoscope training dated 6/15/17. There was no other documentation in the file regarding annual competencies or training with equipment or products in the Sterile Processing Department.

The current Operating Room Services Manager, hired November 2016, lacked documented evidence of any competencies.

A Sterile Processing Technician assigned to evaluate the other Sterile Processing Technicians in July 2017 was hired on 6/22/15. The Sterile Processing Department Clinical Supervisor evaluated this technician for an annual competency on 3/8/16 and Sterrad training on 10/27/16. There was no documentation of a return demonstration verification. The Sterile Processing Technician completed a self-assessment for the clinical orientation competency checklist and the annual competency checklist for the Sterile Processing Department, which were not co-signed by an evaluator.

A Sterile Processing Technician hired 1/24/00 had an annual competency checklist dated 5/10/13 and had received Storz flexible endoscope training dated 6/15/17.

A Sterile Processing Technician hired 3/10/14 had a clinical orientation competency checklist dated 3/8/16. Received Sterrad training on 10/27/16, there was no documentation of return demonstration verification. Received Storz flexible endoscope training dated 6/15/17, had a clinical orientation competency checklist dated 7/11/17 and an annual competency checklist dated 7/11/17. The clinical orientation competency checklist was not co-signed by an evaluator.

A Sterile Processing Technician hired 11/17/14 had a clinical orientation competency checklist dated 3/8/16. The clinical orientation competency checklist was not co-signed by an evaluator. Received Sterrad training on 10/27/16, there was no documentation of return demonstration verification. Received Storz flexible endoscope training dated 6/15/17, had a clinical orientation competency checklist dated 7/12/17 and an annual competency checklist dated 6/12/17. These competency checklists were co-signed by another Sterile Processing Technician.

A Sterile Processing Technician hired 7/18/16 had Sterrad training on 10/27/16, there was no documentation of return demonstration verification. Received Storz flexible endoscope training dated 6/15/17, had a clinical orientation competency checklist dated 7/12/17 and an annual competency checklist dated 7/11/17.

A Sterile Processing Technician hired 8/8/16 had Sterrad training on 10/27/16, there was no documentation of a return demonstration verification. Received Storz flexible endoscope training dated 6/15/17, had a clinical orientation competency checklist and annual competency checklist dated 7/11/17.

A Sterile Processing Technician hired 10/3/16 had an annual competency checklist dated 3/1/17. There was no self assessment by the Sterile Processing Technician or performance level assessed by the evaluator. Received Storz flexible endoscope training dated 6/15/17, had a clinical orientation competency checklist and annual competency checklist dated 7/8/17. The evaluator signed 7/12/17.

A Sterile Processing Technician hired 10/10/16 had Sterrad training on 10/27/16, there was no documentation of return demonstration verification. Received Storz flexible endoscope training dated 6/15/17, had a clinical orientation competency checklist and annual competency checklist dated 7/8/17. The evaluator signed 7/12/17.

A Sterile Processing Technician hired 4/17/17 had Storz flexible endoscope training dated 6/15/17. The Technician had a clinical orientation competency checklist dated 7/10/17. The evaluator signed the document on 7/12/17. The Technician had an annual competency checklist dated 7/11/17, which was not due for another 9 months.

Within the hospital's Infection Prevention and Control Annual Plan for 2017 was a 9-page competency checklist for Karl Storz flexible scopes. On 6/15/17, the training provided by a Karl Storz representative omitted pages 1-4 which covered the equipment, bedside pre-cleaning and the leakage test. The documented training only covered manual cleaning/detergent cleaning, water rinsing, drying and inspection.

The Competency Assessment policy (HR218 revised 1/1/16) revealed it is the responsibility of facility administration and leadership to ensure each facility employee is competent in skills, knowledge, and ability required and safe/effective use of equipment as appropriate to the job description. The competency program included the following components: Credentials and Documents: skill record, core and unit competencies, educational records. Yearly competency assessment included core competencies and unit/department competencies, which addressed, but were not limited to patient population, age-specific skills, use of equipment, acceptable performance of new procedures, and high risk/problem prone tasks and skills, which required validation of performance.

The Human Resources Employee Records policy (HR103 revised 2/18/13) revealed the human resources department would be responsible for maintaining employment records. The policy lacked documented evidence anyone was responsible for checking whether competencies were due for employees.

Based on observation, interview, record review and document review, the hospital's leadership failed to ensure Sterile Processing Department staff received training on the proper cleaning, high-level disinfection, and sterilization procedures for surgical instruments processed in the Sterile Processing Department and failed to follow the Infection Control and Prevention plan for 2017.

Findings include:

1) The hospital used 3 flexible difficult intubation scopes: two were Olympus brand and the third scope was a Karl Storz brand.

On 7/17/17 at 2:20 PM, a Sterile Processing Technician indicated the sterile processing area stopped performing leak tests on the flexible difficult intubation scopes 2 months prior because the newer Sterile Processing Technicians were not performing them. The Sterile Processing Technician was unable to provide documentation leak tests were performed prior to the tests being stopped two months ago.

On 7/17/17 at 2:35 PM, a Sterile Processing Technician verbalized not knowing the cleaning solution to water ratio for the manual cleaning process. The Technician verbalized the pre-cleaner solution should not have been used instead of an enzymatic cleaner for the manual cleaning. The technician did not receive training on the hospital's manual cleaning process or the high-level disinfection process and was told to reprocess leaking scopes if the pressure did not drop fast with a leak test.

There was no specific training in the Sterile Processing Department except for observing other Sterile Processing Technicians. There were no performance competencies completed. There was no patient tracking and no documentation of leak tests in the Sterile Processing Department.

The Sterile Processing Department Clinical supervisor informed the staff via text to begin using the Sterrad sterilization process instead of the high-level disinfection process after 06/08/17.

On 7/18/17 at 9:30 AM, an Olympus representative indicated the instructions for use should have been followed and no steps should have been omitted. The Olympus leak tester should always be used with Olympus scopes, not manual testing. Reusing leaking scopes increased the infection risk for patients because contaminated fluid could have remained in the leaking areas creating a pocket for bacteria. The hospital should have called Sterrad to see if Olympus scopes could be processed in Sterrad.

On 7/18/17 at 9:55 AM, a Karl Storz representative verbalized the cleaning ratio was important to follow for manual cleaning. Technicians should not have been relying on manual leak tests. The training provided on 6/15/17, should have included leak testing. The representative recommended deflection (moving scope handle in both directions) during leak tests or else a leak could have been hidden. Karl Storz had no record of conducting training at the facility prior to June 15, 2017.

On 7/18/17 in the afternoon, the Process Improvement Manager indicated the Sterile Processing Department's Clinical Supervisor (SPDCS) was unable to provide training and in-service documentation for the Sterile Processing Technicians. Sterile Processing Department policies and guidelines were kept on the supervisor's department computer, and the computer could not be accessed to obtain the policies. The facility discovered the reprocessing issues with flexible difficult intubation scopes on 6/8/17.

2) On 7/18/17 at 1:30 PM, a Sterile Processing Technician demonstrated the manual cleaning process for a flexible difficult intubation scope in the decontamination area. The Sterile Processing Technician identified a pre-cleaner to be used for the manual cleaning instead of using an enzymatic cleaner.

The Operating Room Services Manager present during the demonstration read the label on the pre-cleaner and agreed it was not an enzymatic cleaner. The Operating Room Services Manager agreed the product was only a pre-cleaner used to wipe devices/scopes immediately after use in the Operating Room or procedure room.

3) On 7/18/17 in the afternoon, a Sterrad representative indicated the Olympus scopes should have been processed with the duo cycle (60 minutes) in the Sterrad NX100 and the advanced cycle for the Sterrad NX, but the Olympus scopes were not validated for durability in the Sterrad.

A Sterile Processing Technician indicated the facility processed the flexible difficult intubation scopes in the NX100 with the flex cycle, (which was 18 minutes shorter than the duo cycle). The Sterile Processing Technician verbalized the facility did not use the duo cycle on the NX100 model or the advanced cycle on the NX model. The Sterile Processing Department Clinical Supervisor directed the Sterile Processing Technicians to use the Sterrad for the flexible difficult intubation scopes onward from 6/9/17.

The Sterrad NX100 records showed the Olympus flexible difficult intubation scopes were processed on June 9, 14, 15, 19, 27 and 29. On June 29, 2017, all loads were processed with the standard cycle, not the flex cycle for Olympus as the Sterile Processing Technician indicated was the process.

4) The Sterile Processing Technician acknowledged the Sterrad's biological indicators were not being read properly or at all. In many cases, the cultures overlapped shifts, and the following shift did not check or document the results.

5) On 7/18/17 in the afternoon, the Process Improvement Manager and Infection Prevention Manager indicated monthly tracers were completed with each targeted area of the hospital. Corporate dictated the quality tracer questions utilized. The same questions were asked monthly for the past year in the Sterile Processing Department. The Sterile Processing Department did not perform any quality improvement projects within the department.

The Infection Prevention Manager provided the hospital's Infection Prevention and Control Plan for 2017, which placed a high priority on a surveillance plan in the Sterile Processing Department. Planned action for 2017 in the Sterile Processing Department included, continuing monthly/quarterly tracers with follow-up on non-compliant findings in areas that complete high-level disinfection or sterilization. Tracers included evaluation of documentation and process, transportation, and competency completion.

Sterile Processing Department Tracer Observation Reports were reviewed for the past 12 months (July 2016 through June 2017):

The past 12 months showed 100% compliance with completed biological indicator test logs with the proper information recorded for each run (question 15).

A random review of May 1-21, 2017 logs revealed the Sterile Processing Department did not record some biological indicator test results on May 1, 5, 7, 10, 14 (none recorded), 15, 17 and 21. The Sterile Processing Technician acknowledged the gaps in the log.

Infection Control and Prevention Employees documented the Sterile Processing Department Tracer Observation Detail Report with 100% compliance for question 15 for every month in the past year. Question 15 was the completion of biological test indicator logs with the proper information recorded. On 7/19/17 in the morning, the Process Improvement Manager acknowledged question 15 referred to the biological indicator test logs of the Sterrad processors, but the tracer reviewers were not certified sterile processing technicians.

A random review of the 07/11/17 log revealed the biological indicator test results were missing for Sterrad 100, 102 and 103.

6) Question 19 of the monthly Tracer Observation Report asked if the Sterile Processing Department employees completed annual competencies.

From July through December 2016, March 2017, April 2017 and June 2017, the Infection Prevention Observers indicated selected employees completed annual competencies in the Sterile Processing Department for those Tracer Observation Detail Reports.

On 07/19/17 in the afternoon, the Human Resources Director and the Operating Room Services Manager indicated competencies and training could have been kept in the human resources file or the Sterile Processing Department file. Both sets of files were obtained, and all Sterile Processing Technician files were reviewed for orientation, annual competencies and training in the Sterile Processing Department. The Human Resources Director, Operating Room Services Manager and Process Improvement Manager were all present during the review.

The Sterile Processing Department Clinical Supervisor had a competency based orientation document dated 1/28/13. The document was a self-assessment and not co-signed by an evaluator. The Sterile Processing Department Clinical Supervisor had received Storz flexible endoscope training dated 6/15/17. There was no other documentation in the file regarding annual competencies or training with equipment or products in the Sterile Processing Department.

The current Operating Room Services Manager, hired November 2016, lacked documented evidence of any competencies.

A Sterile Processing Technician assigned to evaluate the other Sterile Processing Technicians in July 2017 was hired on 6/22/15. The Sterile Processing Department Clinical Supervisor evaluated this technician for an annual competency on 3/8/16 and Sterrad training on 10/27/16. There was no documentation of a return demonstration verification. The Sterile Processing Technician completed a self-assessment for the clinical orientation competency checklist and the annual competency checklist for the Sterile Processing Department, which were not co-signed by an evaluator.

A Sterile Processing Technician hired 1/24/00 had an annual competency checklist dated 5/10/13 and had received Storz flexible endoscope training dated 6/15/17.

A Sterile Processing Technician hired 3/10/14 had a clinical orientation competency checklist dated 3/8/16. Received Sterrad training on 10/27/16, there was no documentation of return demonstration verification. Received Storz flexible endoscope training dated 6/15/17, had a clinical orientation competency checklist dated 7/11/17 and an annual competency checklist dated 7/11/17. The clinical orientation competency checklist was not co-signed by an evaluator.

A Sterile Processing Technician hired 11/17/14 had a clinical orientation competency checklist dated 3/8/16. The clinical orientation competency checklist was not co-signed by an evaluator. Received Sterrad training on 10/27/16, there was no documentation of return demonstration verification. Received Storz flexible endoscope training dated 6/15/17, had a clinical orientation competency checklist dated 7/12/17 and an annual competency checklist dated 6/12/17. These competency checklists were co-signed by another Sterile Processing Technician.

A Sterile Processing Technician hired 7/18/16 had Sterrad training on 10/27/16, there was no documentation of return demonstration verification. Received Storz flexible endoscope training dated 6/15/17, had a clinical orientation competency checklist dated 7/12/17 and an annual competency checklist dated 7/11/17.

A Sterile Processing Technician hired 8/8/16 had Sterrad training on 10/27/16, there was no documentation of a return demonstration verification. Received Storz flexible endoscope training dated 6/15/17, had a clinical orientation competency checklist and annual competency checklist dated 7/11/17.

A Sterile Processing Technician hired 10/3/16 had an annual competency checklist dated 3/1/17. There was no self assessment by the Sterile Processing Technician or performance level assessed by the evaluator. Received Storz flexible endoscope training dated 6/15/17, had a clinical orientation competency checklist and annual competency checklist dated 7/8/17. The evaluator signed 7/12/17.

A Sterile Processing Technician hired 10/10/16 had Sterrad training on 10/27/16, there was no documentation of return demonstration verification. Received Storz flexible endoscope training dated 6/15/17, had a clinical orientation competency checklist and annual competency checklist dated 7/8/17. The evaluator signed 7/12/17.

A Sterile Processing Technician hired 4/17/17 had Storz flexible endoscope training dated 6/15/17. The Technician had a clinical orientation competency checklist dated 7/10/17. The evaluator signed the document on 7/12/17. The Technician had an annual competency checklist dated 7/11/17, which was not due for another 9 months.

Within the hospital's Infection Prevention and Control Annual Plan for 2017 was a 9-page competency checklist for Karl Storz flexible scopes. On 6/15/17, the training provided by a Karl Storz representative omitted pages 1-4 which covered the equipment, bedside pre-cleaning and the leakage test. The documented training only covered manual cleaning/detergent cleaning, water rinsing, drying and inspection.

The Competency Assessment policy (HR218 revised 1/1/16) revealed it is the responsibility of facility administration and leadership to ensure each facility employee is competent in skills, knowledge, and ability required and safe/effective use of equipment as appropriate to the job description. The competency program included the following components: Credentials and Documents: skill record, core and unit competencies, educational records. Yearly competency assessment included core competencies and unit/department competencies, which addressed, but were not limited to patient population, age-specific skills, use of equipment, acceptable performance of new procedures, and high risk/problem prone tasks and skills, which required validation of performance.

The Human Resources Employee Records policy (HR103 revised 2/18/13) revealed the human resources department would be responsible for maintaining employment records. The policy lacked documented evidence anyone was responsible for checking whether competencies were due for employees.