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Based on observation, interview, and record review, the hospital failed to ensure the GB effectively carried out its responsibilities for the conduct of the hospital as evidenced by:

1. Failed to ensure there were sufficient numbers of qualified IC practitioners to develop and implement hospital IC policies and accomplish the tasks required for the IC program in accordance with nationally recognized IC practices and guidelines. Cross reference to A0748.

2. There was inadequate follow-up of issues identified in multiple areas of the hospital during the investigation of four SSIs of Patients 24, 25, 26, and 27, who had hip and knee joint replacement surgeries in the same OR room in late May to mid-June 2014. Each of the patients had infections with the same bacteria and required one to three follow-up surgeries due to infections. Cross reference to A0749, example #1.

3. There was no documentation to show a follow-up investigation by the IC department of four abdominal SSIs, dating to surgeries in April, may, July and August 2014. Cross reference to A0749, example #2.

4. The hospital's corrective action for previously identified staff noncompliance with the High Level Disinfection process was a revision of a P&P to follow the manufacturer's recommendations and inservice staff for the revised P&P; however, the revised P&P was not reviewed and approved by the Infection Prevention Committee prior to implementation and contradicted another P&P which remained in place. Multiple deficient practices were observed by staff on both hospital campuses and in outpatient procedural areas. Cross reference to A0749, example #4.

5. The quality of contracted services was not been ensured through quality review of contracted dialysis and cleaning services. Cross reference to A0084.

6. The quality improvement program did not ensure the quality of services through facility-wide monitoring, follow-up of adverse events, analysis of quality data and implementation of programs to improve performance. Cross reference to A0263.

The cumulative effect of these systemic failures resulted in the hospital's inability to provide quality healthcare in a safe environment to the patients.

Based on observation, interview, and record review, the hospital failed to provide oversight of the contracted dialysis service (dialysis is a process for removing waste and excess water from the blood when the kidneys are in a state of failure) at the Mission Viejo campus and the contracted cleaning service for the outpatient Endoscopy Center. These failures posed the potential of the spread of infections and could affect the patient's safety and treatment.

Findings:

1. On 10/13/14 at 1420 hours, the ICU Director stated the hospital's dialysis service was supplied by a contracted vendor. The Director stated she was designated as the dialysis liaison.

The dialysis equipment storage area was observed on 10/13/14 at 1445 hours, with the ICU Director, Dialysis RN 1, and Vice President 1. The following was identified:

* A white bucket containing a clear liquid hung on the screws from the back of the RO system (reverse osmosis is a system used to purify water) attached to the back of the dialysis machine. The screws appeared greenish and rusty when the white bucket was removed by Dialysis RN 1.

* The base of the dialysis machine had an crusty area, measuring approximately 0.5 cm by 0.5 cm.

* The edge of the dialysis machine was observed with peeled paint.

* A large black container was noted on the top of the RO system. The bottom of the large black container was dusty.

Dialysis RN 1 confirmed the above findings. The RN stated the buckets were used to collect water dripping from the machine. The RN stated the dialysis machine was cleaned from the top to the base after each treatment.

The ICU Director and Vice President 1 were asked how the hospital ensured the dialysis machines were cleaned and disinfected properly. Both staff stated they would have to look for the information.

During a follow-up interview and concurrent document review with Vice President 1 on 10/14/14 at 1345 hours, Vice President 1 provided a Medical Equipment document from EOC rounds in May 2014.

Review of the Medical Equipment documentation dated 5/9/14, entered by the Director of Clinical Engineering showed the question "equipment is clean and in proper working order" was answered as "yes." However, there was no documented evidence to show the dialysis machines were inspected for cleanliness. Vice President 1 verified the finding.

2. Review of the Fresenius Dialysis Delivery System Cleaning and Disinfection Policy reviewed 9/12, showed the following:

* The facilities will develop a specific Dialysis Delivery System Cleaning and Disinfection Log in conjunction with the Biomedical Department. Cleaning and disinfection of dialysis delivery system will be documented on the log.

* The same dialysis delivery system is not to be used for both HBsAg (Hepatitis B surface antigen) positive (a positive HBsAg indicates a current infection) and HBV (Hepatitis B virus) susceptible patients unless the internal fluid pathway of the delivery system had been disinfected and external surface cleaned with a 1:100 (one to one hundred) bleach solution.

Review of the dialysis supplier's P&P titled Hepatitis Surveillance and Infection Control Measure revised 3/14, showed susceptible patients are defined as both HBsAg negative and Hepatitis B surface antibody (HBsAb) negative (surface antibodies less than 10 mIU per ml).

Review of the Infection Prevention Record for dialysis Machine 1 showed one treatment was performed on 9/10/14, for Patient 20. The patient's HBsAg was documented as negative on 8/6/14. The HBsAb was "0." The record showed at 2000 hours, the machine was disinfected; the VR (vinegar rinse) cycle was circled; the HD (Heat) cycle was circled; and the BR (Bleach rinse) cycle was left blank.

a. An interview and concurrent review of the Infection Prevention Record was conducted with Dialysis RN 2 on 10/14/14 at 1400 hours. The RN confirmed Patient 20's HBsAg and HBsAb were tested on 8/6/14, and were negative. The RN verified the dialysis machine was not disinfected by using a bleach cycle. The Dialysis RN stated the BR cycle should be done on the machine after treatment.

During an interview and concurrent document review with Executive Director 1 on 10/14/14 at 1410 hours, the Executive Director stated he was designated to evaluate the contracted dialysis service. When asked if he reviewed the Infection Prevention Record for the dialysis service to ensure the P&Ps were implemented, the Vice President stated he did not have dialysis expertise; therefore, he relied on the contracted vendor.

b. On 10/14/14 at 1530 hours, Dialysis RN 2 provided the Acute Hemodialysis record showing Patient 20 had HBsAg and HBsAb tested on 8/26/14, not 8/6/14. The Dialysis RN confirmed the Infection Prevention Record was not accurate.

3. Review of the Fresenius Dialysis Delivery System Cleaning and Disinfection Policy reviewed 9/12, showed the effectiveness of cleaning and disinfection will be evaluated monthly by review of environmental microbial testing results.

Review of the section of the Surveillance Plan for fiscal year 2014 of the Infection Prevention Program Plan showed renal (kidney) dialysis water surveillance included bacteriological water surveys collected monthly by the contracted vendor and BioMed would be reported to the Infection Prevention Committee quarterly.

An interview and concurrent document review from the contracted vendor was conducted with the ICU Director and Vice President 1 on 10/13/14 at 1420 hours. The ICU Director stated the hospital's dialysis service was supplied by a contracted vendor. The Director stated she was designated as the dialysis liaison.

The Director stated the contracted dialysis service was reviewed quarterly. When asked, both staff was unable to locate documented evidence to show the results of bacteriological water testing from the machines was collected and filed. The Director stated she would ask for the information from the Director of Clinical Engineering.

On 10/14/14 at 1300 hours, Vice President 1 provided the bacteriological water testing results from the dialysis machines. The Vice President stated the results were printed out yesterday by the Director of Clinical Engineering. The Vice President stated the Director of Clinical Engineering would receive and review the results and bring them to the EOC committee monthly; the testing results would be presented to the Infection Prevention Committee when an issue was identified. However, the Vice President stated the last time the results of bacteriological water testing of the machines was brought to the EOC for review was in June 2013.


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4. During a tour of procedure room 2 in the Outpatient Endoscopy Center on 10/10/14 at 1120 hours, the Manager stated no cases were scheduled in the room that day. Observation of the room showed the top of the supply cart had a black residue.

The Manager stated terminal cleaning of the procedure rooms was done by a contracted cleaning service at the end of the day. The Manager confirmed the room was cleaned the prior night. When asked, the Manager stated the hospital did not perform observations of the cleaning contractor personnel; however, their training was documented. The Manager stated Super Sani-Cloth (disinfectant) wipes were used by the housekeeper to clean surfaces in the room.

A Super Sani-cloth wipe was applied to the black residue on top of the procedure room supply cart by the surveyor. The residue wiped away immediately.

During an interview with the CEO on 10/14/14 at 0910 hours, he stated the hospital did have a system in place for providing oversight of contracted services; however, it might not have provided oversight of the contracted cleaning services at the Outpatient Endoscopy Center due to the recentness of the hospital's ownership of the center. When asked, the CEO stated the Endoscopy Center was acquired by the hospital more than a year prior.

Based on observation, interview, and record review, the hospital failed to implement and maintain a data-driven QAPI program designed to maximize the quality of care and safety of services provided to the patients as evidenced by:

1. The hospital did not implement an effective, ongoing, data-driven QAPI program to utilize data available, such as data regarding a contracted dialysis provider, monitoring of the safety and quality of services provided, and did not analyze and track processes of care, such as the documentation of continued need for central lines, creating the risk of persistent poor practices and substandard healthcare. Cross reference to A0273.

2. The hospital's quality program did not use data collected to identify opportunities for improvement, and did not focus on issues that affect health outcomes and patient safety. There was no program aimed at improving hand hygiene and the hospital's infection prevention plan was not implemented to reduce the risks of infection and the spread of disease. In addition, the quality program did not ensure completion of staff health screening for three medical staff. Cross reference to A0283.

3. The hospital failed to ensure adverse events, such as surgical site infections, an unexpected ER visit after a procedure, and opportunities for improvement identified pursuant to grievances, were analyzed and formed the basis for learning and improvement of services, creating the risk of persistent poor practices and substandard healthcare. Cross reference to A0286.

4. The GB failed to ensure the hospital's quality assurance program reflected the complexity of the hospital's functions and was designed, implemented, and maintained. Monitoring of outpatient areas was not completely integrated into the QAPI program, the contracted dialysis service was not thoroughly evaluated for their performance, and there were not clear expectations from the GB regarding the frequency and level of detail of quality assurance data gathered. Cross reference to A0308.

The cumulative effect of these systemic failures resulted in the hospital's inability to provide quality healthcare in a safe environment.

Based on observation, interview, and record review, the hospital failed to utilize data available, such as data regarding a contracted dialysis provider to monitor the safety and quality of services provided, and did not analyze and track processes of care, such as the documentation of continued need for central lines. In addition, there was incomplete collection and presentation of hand hygiene data. These failures created the risk of persistent poor practices and substandard healthcare in the hospital.

Findings:

During an interview with the CEO on 10/14/14 at 0840, he stated the Managers of each department had measurable quality goals; however, the CEO stated staff was delayed in producing the data about performance due to work load.

During an interview with the Executive Director of Quality and Patient Safety on 10/10/14 at 1525 hours, she stated the SCIP measures were the only measures presented for surgery. She stated the RCA of the orthopedic surgical site infections were presented to the Perfect Care Committee on 4/14 and 10/14.

1. According to the CDC's Guidelines for the Prevention of Intravascular Catheter-Related Infections 2011, recommendations included to identify and promptly remove unnecessary central IV catheters during daily patient rounds.

Review of the hospital's P&P titled Intravascular Devices and Central Lines: Care and Maintenance dated 1/13, showed a central venous catheter was defined a sterile hollow tube inserted through a major vein.

Guidelines for insertion and care of the line included for the physician to assess the need to continue a patient's central venous catheter daily and document that assessment.

During a tour of the Medical Surgical Oncology unit on the Mission Viejo campus on 10/10/14 at 1345 hours, the Nursing Manager was asked how physicians documented the daily assessment of the need for continuing a patient's central IV catheter. The Manager stated she was not sure how that was done.

In an interview with MD 2 on 10/10/14 at 1430 hours, the MD opened a patient's EHR to show the staff and surveyor how the need for continuing a patient's central IV catheter was documented in the progress notes. The MD stated this was done daily.

Review of the medical records for Patients 9, 10, 11, 12, and 21 on 10/10/14, did not show the continuing need for the central IV catheter was assessed and documented by the physician after the insertion date. Cross reference to A0749, example # 5.

During an interview with the Chief Clinical and Nursing Officer on 10/13/14 at 0930 hours, the Nursing Officer stated she thought the physicians were educated quite a while ago to do this. When asked, the Nursing Officer stated she thought medical records audited for compliance.

During an interview with MD 1, the hospital's IC Consultant and the CMO on 10/13/14 at 1350 hours, both physicians stated documentation of a daily assessment for the continuation of a patient's central IV catheter was not identified by the hospital as an issue.

MD 1 stated he was aware there were gaps in documenting the need for continuing central lines. MD 1 stated it was difficult to use the computer to audit the records for documentation of necessity. MD 1 stated he suggested introducing a question into the electronic health record so staff had a standardized response area that could be audited; however, this change was not made.

During an interview with the Executive Director of Quality & Patient Safety on 10/13/14 at 0830 hours, the Director confirmed there was no follow up by the hospital to ensure physician's documented a daily assessment for the continuation of a patient's central IV catheter.



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2. During the observation, interview, and document review on 10/13 and 10/14/14, the contracted dialysis service was found deficient in the following areas:

* The dialysis machine was not cleansed and disinfected in accordance to the dialysis supplier's P&P. Cross reference to A0084.

* The environmental microbial testing results for dialysis machines were not collected and reviewed as planned. Cross reference to A0084.

Review of the section of the Surveillance Plan for fiscal year 2014 of the Infection Prevention Program Plan showed renal (kidney) dialysis water surveillance included bacteriological water surveys collected monthly by the contracted vendor and BioMed would be reported to the Infection Prevention Committee quarterly.

An interview and concurrent document review from the contracted vendor was conducted with the ICU Director and Vice President 1 on 10/13/14 at 1420 hours. The ICU Director stated the hospital's dialysis service was supplied by a contracted vendor. The Director stated she was designated as the dialysis liaison.

The Director stated the contracted dialysis service was reviewed quarterly. When asked, both staff was unable to locate documented evidence to show the results of bacteriological water testing from the machines was collected and filed. The Director stated she would ask for the information from the Director of Clinical Engineering.

On 10/14/14 at 1300 hours, Vice President 1 provided the bacteriological water testing results from the dialysis machines. The Vice President stated the results were printed out yesterday by the Director of Clinical Engineering. The Vice President stated the Director of Clinical Engineering would receive and review the results and bring them to the EOC committee monthly; the testing results would be presented to the Infection Prevention Committee when an issue was identified. However, the Vice President stated the last time the results of bacteriological water testing of the machines was brought to the EOC for review was in June 2013.

During an interview and concurrent document review with Executive Director 1 on 10/14/14 at 1410 hours, the Executive Director stated he was designated to evaluate the contracted dialysis service. When asked if he reviewed the Infection Prevention Record for the dialysis service to ensure P&Ps were implemented, the Vice President stated he did not have dialysis expertise; therefore, he relied on the contracted vendor.


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3. The hospital's Infection Prevention Risk Assessment for FY2014, showed monthly hand hygiene audits were performed by infection prevention or the infection prevention team RN. Data showed hand hygiene compliance was 43-73%.

The hospital's Infection Prevention Risk Assessment for FY2015 (started 7/1/14), showed hand hygiene compliance remained at 53% for staff entering a patient room and 59% for staff exiting a room.

During an interview with the Outpatient Endoscopy Center's Manager on 10/10/14 at 1120 hours, the Manager stated there was a hand washing audit on 5/31/13, but none since.

In an interview with MD 1, the IC Consultant on 10/13/14 at 1350, he stated he was aware of the hand hygiene program in the hospital and the hand hygiene data. MD 1 concurred hand hygiene compliance levels in the hospital were still well below the target of 90 to 100%. MD 1 stated there was a secret observer program which was to report data on hand hygiene to infection prevention; however, this was not done for the past few months. MD 1 stated the observers were not expected to go to the Outpatient Endoscopy Center. MD stated he was not sure how monitoring was to occur there.

During an interview with the Chief Clinical and Nursing Officer on 10/13/14 at 0930 hours, she stated hand hygiene data and information on central line infections would be presented at the Nursing Quality Council which presented to the Coordinating Council. The Nursing Officer stated she sat on the Coordinating Council.

The Nursing Officer stated the IC practitioners were to do hand hygiene audits; however, since the IC staff were on leave or had resigned, she was not sure who was coordinating hand hygiene audits. The Nursing Officer stated nurses from each unit were on the infection prevention subcommittee but thought the subcommittee was probably not meeting.

4. Information on out of range operating room temperatures was not reported and discussed. Cross reference to A0726, example #1.

Based on interview and record review, the hospital's QAPI program failed to use data collected to identify opportunities for improvement and failed to focus on issues that affected health outcomes and patient safety. There was no program aimed at improving hand hygiene and the hospital's infection prevention plan was not implemented to reduce the risks of infections and spread of diseases. In addition, the QAPI program did not ensure completion of staff health screening for three medical staff. These failures created the risk of substandard healthcare for the patients in the hospital.

Findings:

1. The hospital's Infection Control Plan for FY2014, reviewed 7/13, indicated the plan included, "Promotion of hand hygiene among staff, employees and visitors." The Infection Prevention Annual Risk Assessment 2014, reviewed 7/13, rated hand hygiene noncompliance as highly likely, with a high potential impact on patients and the facility, and as a high priority issue.

During an interview with the Clinical Director of Perioperative Services on 10/13/14 at 1500 hours, she stated all areas were to conduct hand hygiene audits, but that this was not a high priority. The Director stated there was handwashing education in June or July 2013, and intermittent audits since.

A Proposal for Infection Prevention Team dated January 2014, by the previous Infection Prevention Manager showed a proposal to reduce hospital acquired infections and increase hand hygiene compliance. The proposal showed hand hygiene compliance rates of 43% before entering a patient room, 68% upon leaving the room at the main hospital campus, 50% before entering a patient room, and 62% after exiting the room at the Laguna Beach campus. The proposal included using unit based nurses who would receive pay for training, meetings, and tasks.

During an interview with the Executive Director of Quality and Patient Safety on 10/14/14 at 1435 hours, she stated a hand hygiene monitoring proposal was made by the previous Infection Prevention Manager, but the program was not funded.

In an interview with MD 1, the IC Consultant on 10/13/14 at 1350 hours, he stated he was aware of the hand hygiene program in the hospital and the hand hygiene data. MD 1 concurred the hand hygiene levels in the hospital were still well below the target of 90 to 100%. MD 1 stated periodically attention was focused on hand hygiene, but there were no new strategies developed or implemented to improve the performance.

2. The Infection Prevention Annual Risk Assessment for FY2014, reviewed 7/13, showed there were high risks associated with devices or procedures (such as SSIs and central line infections), equipment use (disinfection and sterilization), pathogen exposure, and employee misuse of protective equipment, and that these should be considered high priority issues.

a. The hospital's corrective action for previously identified staff noncompliance with the HLD process was a revision of a P&P to follow the manufacturer's recommendations and inservice staff for the revised P&P; however, the revised P&P was not reviewed and approved by the Infection Prevention Committee prior to implementation and contradicted another P&P which remained in place. Multiple deficient practices were observed by staff on both hospital campuses and in outpatient procedural areas. Cross reference to A0749, example #4.

b. Review of the hospital's P&P addressing the use of a glucometer (machine that measures a blood glucose sample obtained at the bedside) dated 1/30/14, showed staff should disinfect the meter between each new patient using a disinfectant wipe.

During an interview with RN 8 in the SICU on 10/10/14 at 1050 hours, the RN stated the Super Saniwipe Cloth (disinfectant wipe) was used to clean the glucometer in between patients. When asked if there was a required amount of time for the glucometer to stay wet when wiping the product, the RN stated she believed it was 30 seconds.

During an interview with RN 5 in the Mission Viejo Campus ER on 10/10/14 at 1525 hours, the RN stated Super Saniwipe Cloth was used to clean surfaces, including the glucometer. RN 5 stated the chemical disinfectant worked in 15 to 30 seconds.

The manufacturer's directions on the container for the disinfectant wipes showed a two minute wet contact time was required.

c. The Infection Control Plan for FY2014, showed infection prevention EOC rounds would be conducted monthly, and that personal protective equipment and glucometer cleaning would be monitored on the rounds.

The EOC Committee's minutes for the monthly meetings from January 28, 2014 to July 29, 3014 were reviewed. The minutes contained a section for infection prevention and the minutes for each of the monthly meetings contained the exactly the same wording.

During an interview with the Clinical Director of Perioperative Services on 10/13/14 at 1335 hours, she concurred the IC section of the EOC meeting minutes appeared incomplete and stereotyped.

The Environment of Care Quality of Care Report dated 3/3/14, was reviewed on 10/13/14. The report contained sections for safety injuries, hazardous materials and waste, security, fire/life safety, medical equipment, utility systems, and emergency management, but there was no section for data on infection prevention and control.

During an interview with the Executive Director of Quality and Patient Safety on 10/13/14 at 1445 hours, she stated the infection prevention EOC rounds were not performed for several months.

3. The Infection Control Plan for FY2014, showed staff would be screened for TB and influenza vaccination or declination would be required for all staff. The infection prevention program was to collect and review the data.

The Environment of Care Quality of Care Report dated 3/3/14, was reviewed on 10/13/14. There was a notation under "employee injuries" about a staff member's TB exposure in January 2013.

Medical staff and allied health provider's credential files were reviewed on 10/13 and 10/14/14.

CRNA 1 was appointed on 12/3/12. CRNA 1's file did not include information about influenza vaccination or declination of the vaccine for 2013.

MD 4 was appointed to the medical staff prior to 2013, but there was no documentation of influenza vaccination or declination of the vaccine for 2013.

PA 1 was appointed 2/13, but there was no documentation about TB testing, immunization, or vaccinations in the file.

4. The Infection Control Plan for FY2014, showed there would be a daily review of all cultures.

During an interview with the Executive Director of Quality and Patient Safety on 10/13/14 at 1335, she stated she believed the IC Consultant reviewed positive cultures in the hospital.

During an interview with MD 1, the IC Consultant on 10/13/14 at 1340 hours, he stated he was not reviewing positive cultures. MD 1 stated if the infection prevention team did not report issues to him, he would not know about the IC problems or questions in the hospital.

During an interview with the Executive Director of Quality and Patient Safety on 10/13/14 at 0830 hours, she stated clinical nurses were collecting infection data, and if the infection was increasing this was noted. The Director further stated this data was presented at the Quality of Care Committee and eventually put on the agenda for the MEC and GB meetings.

During an interview with the IC Manager on 10/9/14 at 1205 hours, she stated there was a part-time IC nurse working at the hospital three days per week and a consultant in infection prevention present two days per week. The Manager stated the previous IC Manager left 9/2/14, and she was not sure of the level of training of the IC personnel. The Manager stated she had concerns regarding the inadequate number of staff performing the IC.

In an interview with MD 1, the IC Consultant on 10/13/14 at 1430 hours, he stated there was not enough IC staff to provide oversight of the IC practices in the hospital.

Based on interview and record review, the hospital failed to ensure adverse events, such as SSIs, unexpected ER visits after a procedure, and opportunities for improvement identified pursuant to grievances were analyzed and formed the basis for learning and improvement of services, creating the risk of persistent poor practices and substandard healthcare in the hospital.

Findings:

1. The hospital Infection Control Plan for FY2014 (dated 7/2013), showed surveillance activities were to include monitoring of "All surgical site infections to determine if there are clusters of infections related to surgeon, service, pathogens, product, etc."

a. The Executive Director, Quality & Patient Safety was interviewed on 10/10/14 at 0850 hours. The Director stated the hospital noted a cluster of SSIs in the Mission Viejo campus OR in May and June 2014.


An RCA was held on 7/28/14, with the staff involved and an action plan was put into place; however, there were gaps and insufficient follow-up in implementing the action plan by the different departments involved, including Perioperative Services and the IC Department. The Director stated at this time, the hospital had voluntarily ceased performing elective surgeries and was in the process of retraining staff and auditing the RCA follow-up items to ensure compliance and completion.

The RCA held on 7/28/14, reviewed the SSIs of Patients 24, 25, 26, and 27 who had hip and knee joint replacement surgeries in OR 8, late May to mid-June 2014. Each of the patients had infections with the same bacteria and required one to three follow-up surgeries due to infections.

An RCA is a structured team process that assists in identifying underlying factors or causes of an adverse event or near-miss. Understanding the contributing factors or causes of a system failure can help develop actions that sustain the correction.

Review of the RCA dated 7/28/14, showed 11 areas were reviewed and issues were identified with potential problems, including out of range temperature and humidity levels in the OR; the OR ventilation system; IUSS; sterile processing of instruments; sterilization of loaner instruments; cleaning of the OR between cases; terminal cleaning of the ORs, gurneys at the end of the day, surgical attire, and personal equipment brought in to OR rooms; communication; and future projects. Cross reference to A0749, example #1.

b. Four abdominal SSIs were reviewed. The Current Summary sheet for each infection showed the incidents dated to surgeries on 4/23/14 (detected 5/9/14), 5/17/14, 7/17/14 and 8/27/14, were discussed in a meeting on 9/16/14. There was documentation of a discussion with the IC Consultant; however, there was no documentation of a follow-up investigation by the IC Department. There was a note on each file indicating the files were assigned for additional review.

The Executive Director of Quality and Patient Safety was interviewed on 10/14/14 at 1600 hours. The Director stated she was not sure whether the three abdominal infection cases were reviewed yet or if the abdominal infection case detected in May 2014, was referred for review.

In an interview with MD 1, the IC Consultant on 10/13/14 at 1340 hours, he stated in some cases, the causes of SSIs were not re-examined.

2. Review of Patient 19's medical record on 10/10/14, showed the patient was discharged to home after a GI procedure on 10/6/14; however the patient went to the emergency room later day.

Documentation from the GI procedure showed Patient 19 was elderly with a history of COPD. The patient came in for a colonoscopy (a test to look at the inner lining of the large intestine [rectum and colon] using a thin, flexible tube).

The record showed the patient's pre-procedure vital signs included an oxygen saturation level of 96% (normal 95-100%). The discharge vital signs included an oxygen saturation level of 92%. The discharge worksheet contained items to check off to indicate whether the patient had returned to pre-procedure baseline values. Even though the patient's oxygen saturation level declined to 92%, a "yes" was checked off to indicate the patient had returned to respiratory baseline. There was a space in which follow-up could be documented; however, that space was left blank.

During an interview with the Manager of the Outpatient Endoscopy Center on 10/10/14 at 1130 hours, she stated when an incident occurred, she reviewed the medical record and then the quality department reviewed the medical record. The Manager stated the discharge documentation did not reflect the change in the patient's oxygen saturation. The Manager stated she would have checked "no" for Patient 19 to indicate the patient had not returned to baseline and would have notified the anesthesia provider of the decreased oxygen saturation levels.

During an interview with the Performance Improvement Analyst on 10/10/14 at 1140 hours, she stated Patient 19's record was reviewed as the patient went to the ER on the day of the GI procedure. The Analyst stated she checked to determine whether peer review of the case was needed to make sure there was no evidence of sepsis when the patient presented to the ED; however, she did not check whether the patient was appropriately discharged from the Outpatient Endoscopy Center. The Analyst stated there was no policy regarding incident review.

3. During a review of the grievances of Patients 22 and 23 on 10/10/14, incomplete documentation was found regarding the follow-up of the incidents that lead to the grievances.

a. Patient 22 came to the ER on 5/5/14, with chest pain. The patient complained of a delay in service. The resolution letter sent to the patient showed an EKG was not performed for over 90 minutes after arrival and a physician evaluation did not occur for over 2 hours after arrival.

On the complaint summary form, the section for resolution and outcomes showed the severity level of the incident was listed as "pending." The area for indicating whether the complaint was substantiated showed "unknown/unsure."

b. Patient 23 was admitted to the hospital on 1/27/14, with pneumonia. Despite treatment, the patient's condition deteriorated. The patient's family member wrote a complaint containing two allegations, including the allegation the family was not notified about changes of condition as requested.

The grievance file contained documentation the allegation was reviewed and an opportunity for improvement was identified. However, there was no documentation indicating the finding was used as the basis for learning and improvement in the hospital. The response letter indicated the feedback provided by the complainant would be shared with the staff members; however, there was incomplete documentation to show this occurred as it appeared the file was initially sent to the wrong department and there was no additional documentation to show the file found its way to the correct Nursing Supervisor for review or that feedback to staff occurred.

During an interview with the Executive Director of Quality and Patient Safety on 10/14/14 at 1435 hours, she stated the grievances for Patients 22 and 23 should be closed; however, the Department Director was not in place at that time to ensure the grievances were closed. The Executive Director stated many times incident reviews were not closed out although the quality department sent out reminders to the responsible parties.

Based on interview and record review, the GB failed to ensure the hospital's QA program reflected the complexity of the hospital's functions and was designed, implemented, and maintained. Monitoring of outpatient areas was not completely integrated into the QAPI program, the contracted dialysis service was not thoroughly evaluated for their performance, and there were no clear expectations from the GB regarding the frequency and level of detail of QA data gathered, creating the risk of persistent poor practices and substandard healthcare in the hospital.

Findings:

1. During an interview with the Manager of the Outpatient Endoscopy Center on 10/10/14 at 1030 hours, she stated handwashing surveillance was done "a while ago." The Manager was asked to present the most recent handwashing surveillance data. During a second interview at 1120 hours, the Manager stated there was a handwashing audit on 5/31/13, but none since.

In an interview with MD 1, the IC Consultant on 10/13/14 at 1350 hours, he concurred the hand hygiene levels in the hospital were still well below the target of 90 to 100%. MD 1 stated there was a secret observer program which was to report data to infection prevention, but this was not done for the past few months. MD 1 stated the observers were not expected to go to the Outpatient Endoscopy Center, and he was not sure how monitoring was to occur there.

2. During an interview with the Executive Director, Quality & Patient Safety on 10/13/14 at 0830 hours, she stated departments were supposed to be developing quality parameters. The Director stated the Manager and Director for each department were to follow up whether QA was carried out. The Director stated leadership was not responsive in all departments.

During an interview with the CEO on 10/14/14 at 0840 hours, he stated the Department Managers each had measurable quality goals, but staff was delayed in producing the data about performance due to work load.



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3. During an observation, interview, and document review on 10/13 and 10/14/14, the contracted dialysis service was found deficient in the following areas:

* The dialysis machine was not cleansed and disinfected in accordance to the dialysis supplier's P&P. Cross reference to A0084.

* The environmental microbial testing results for dialysis machines were not collected and reviewed as planned. Cross reference to A0084.

During an interview with the Executive Director, Quality & Patient Safety on 10/14/14 at 1335 hours, the Executive Director was asked about the hospital's oversight of the contracted dialysis services. She stated dialysis service was provided by a contracted dialysis agency. The Director stated quality indicators were reviewed and developed into the contracted agreement. When the contracted agreement was signed, her role was ended.

Based on interview and record review, one of two physicians reviewed (MD 5) and one of two CRNAs reviewed (CRNA 2) did not have all expected appraisal documentation in their credential files, creating the risk of substandard healthcare services by those providers.

Findings:

Medical staff and allied health provider credential files were reviewed on 10/13 and 10/14/14, with the Medical Staff Coordinator.

1. CRNA 2 was appointed on 11/22/12. A letter from the Medical Staff dated 12/5/12, showed a 30 day retrospective audit of the CRNA's medical records was planned.

During an interview with the Medical Staff Coordinator on 10/14/14 at 1300 hours, she stated the audit was not documented.

2. MD 5 was reappointed on 9/20/13. However, there was no letter of reference provided at the time of reappointment.

During an interview with the Medical Staff Coordinator on 10/14/14 at 1300 hours, she stated one letter of reference was required at the time of reappointment and should be in the credential file.

Based on interview and record review, the hospital failed to ensure nursing staff provided ongoing assessments of the needs of five of 30 sampled patients (Patients 13, 14, 15, 18, and 19) as evidenced by:

* The physician was not notified when Patient 15's temperature was elevated and there was no assessment of the patient's PICC for one shift.

* Patient 14 was not assessed every two hours as per the CICU's P&P after a surgery.

* A physician's order was not obtained for the use of indwelling urinary catheters for Patients 13 and 14.

* Patient 18's GT site was not assessed.

* Patient 19's discharge documentation did not reflect the change in the patient's oxygen saturation (total amount of oxygen in the blood) following an outpatient GI procedure.

These failures posed the potential for unsafe care to the patients.

Findings:

1. Review of the hospital's P&P titled Assessment/Reassessment of Patients, effective date of 8/13/14, showed the nursing unit specific assessment and reassessment criteria for the Cardiac and Surgical ICUs included the following:

* A complete systems assessment "is documented at the beginning of each shift or more frequently on the 24 hour flow sheet, depending on the stability and clinical signs and symptoms pertaining to a change in the patient's condition, a change in level of consciousness, abnormal findings from a previous assessment, to determine response to interventions and/or treatment, as defined specific standard of care requirements, any significant change in diagnosis or any physician order. A complete assessment shall include skin assessment, and temperature.

* A focused assessment is documented every two hours on all patients. Any significant changes in patient condition will be reported to the charge nurse and/or physician.

Review of the hospital's P&P titled Care of the Critically Ill/Injured Adult, effective date of 10/1/11, showed the physician will complete the admission orders providing direction for patient management when the patient is admitted to the SICU/CICU.

a. Review of Patient 15's medical record was initiated on 10/13/14. The patient was admitted to the hospital on 10/8/14.

Review of the History & Physical Report dictated on 10/9/14 at 1252 hours, showed Patient 15 had left lower extremity cellulitis (a skin infection when bacteria spread through the skin to deeper tissues).

* Review of the Temperature-History showed Patient 15's temperatures were 100.9 degrees F (normal range is 97.5 to 100.4 F) on 10/10/14 at 0000 hours, 100.2 degrees F on 10/10/14 at 1225 hours, 101.1 degrees F on 10/10/14 at 2000 hours, 100.2 degrees F on 10/11/14 at 0844 hours, and 100.4 degrees F on 10/11/14 at 1145 hours.

Review of the Event/Shift/Hand-Off dated 10/11/14 at 0515 hours, showed Patient 15 had no significant changes in condition. The patient had a fever that spiked at the beginning of the shift and was controlled with Tylenol (a medication used for fever).

There was no documented evidence to show the physician was notified when Patient 15's temperature was elevated to 101.1 degrees F on 10/10/14 at 2000 hours.

An interview and concurrent medical record review was conducted with RN 5 on 10/13/14 at 1115 hours. When asked, the RN was unable to find documented evidence to show the physician was notified when Patient 15's temperature elevated to 101.1 degrees F on 10/10/14 at 2000 hours. The RN stated the physician should be notified about the patient's elevated temperature.

* Review of the Insert PICC Line Adult form dated 10/10/14 at 1602 hours, showed a PICC line was inserted for Patient 15 on 10/10/14 at 1110 hours.

Review of the IV/Invasive Line Assessment failed to show Patient 15's PICC line was assessed on 10/12/14, on the night shift.

An interview and concurrent medical record review was conducted with RN 5 on 10/13/14 at 1115 hours. The RN stated the patient's PICC line would be assessed every shift. When asked, the RN was unable to find documented evidence to show nursing staff assessed Patient 15's PICC line on 10/12/14, on the night shift.

b. Review of Patient 14's medical record was initiated on 10/13/14. The patient was admitted to the hospital on 10/7/14. The patient had a surgery on 10/12/14 and went to the CICU on 10/12/14 at 1605 hours.

* Review of the Perioperative Clinical Record dated 10/12/14, showed Patient 14 had CABG surgery.

Review of the Physical Assessment ICU form showed nursing staff assessed Patient 14 on 10/12/14 at 1600 and 2000 hours, and on 10/13/14 at 0000 and 0400 hours.

There was no documented evidence to show nursing staff conducted a focused assessment every two hours of Patient 14 as per hospital's P&P.

An interview and concurrent medical record review was conducted with RN 5 and the ICU Director on 10/13/14 at 1045 hours. The RN confirmed the assessments were conducted of Patient 14 every four hours on the above dates.

* Review of Patient 14's OR Case Record showed an indwelling urinary catheter was inserted in the OR.

Review of the Physical Assessment ICU-Genitourinary Assessment showed Patient 14's indwelling urinary catheter was inserted on 10/12/14. The indwelling catheter criterion was due to epidural/spinal anesthesia and strict intake and output monitoring.

There was no documented evidence to show nursing staff obtained a physician's order for the use of an indwelling urinary catheter for Patient 14 after the surgery when the patient was admitted to the CICU.

There was no documented evidence to show the physician ordered strict I&O for Patient 14.

During an interview and concurrent medical record review with RN 5 on 10/13/14 at 1045 hours, the RN confirmed the findings.

c. Review of Patient 13's medical record was initiated on 10/13/14. The patient was admitted to the hospital and had a surgery on 10/11/14. The patient was admitted to the SICU on 10/11/14 at 2145 hours.

Review of the Care Activity-Assessment from dated from 10/11/14 at 2200 hours, to 10/13/14 at 0600 hours, showed Patient 13 had an indwelling urinary catheter.

There was no documented evidence to show nursing staff obtained a physician's order for the use of an indwelling urinary catheter for Patient 13 after the patient was admitted to the SICU.

An interview and concurrent medical record review was conducted with RN 4 on 10/13/14 at 0935 hours. The RN stated an indwelling urinary catheter was inserted for Patient 13 when the patient was in the OR. However, the RN was unable to find documented evidence to show a physician's order was obtained for the continued use of the indwelling urinary catheter when the patient was admitted to the SICU.

d. Review of Patient 18's medical record was initiated on 10/13/14. The patient was admitted to the hospital on 10/5/14. The patient had a GT.

Review of the Physical Assessment ICU form dated from 10/11/14 at 0001 hours to 10/13/14 at 1204 hours, failed to show Patient 18's GT site was assessed for skin condition.

An interview and concurrent medical record review was conducted with RN 5 on 10/13/14 at 1445 hours. The RN stated a GT site would be assessed every four hours when nursing staff conducted the physical assessment of the patient. When asked, the RN was unable to find documented evidence to show nursing staff assessed Patient 18's GT site from 10/11/14 at 0001 hours to 10/13/14 at 1204 hours.


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2. Review of Patient 19's medical record on 10/10/14, showed the patient was discharged to home after a GI procedure on 10/6/14; however, the patient went to the ER later that day.

Documentation from the GI procedure showed Patient 19 was elderly with a history of COPD. The patient came in for a colonoscopy.

The record showed the patient's pre-procedure vital signs included an oxygen saturation level of 96% (normal 95-100%). The discharge vital signs included an oxygen saturation level of 92%. The discharge worksheet contained items to check off to indicate whether the patient had returned to pre-procedure baseline values. Even though the patient's oxygen saturation level declined to 92%, a "yes" was checked off to indicate the patient had returned to respiratory baseline. There was a space in which follow-up could be documented; however, that space was left blank.

During an interview with the Manager of the Outpatient Endoscopy Center on 10/10/14 at 1130 hours, she stated when an incident occurred, she reviewed the medical record and then the quality department reviewed the medical record. The Manager stated the discharge documentation did not reflect the change in the patient's oxygen saturation. The Manager stated she would have checked "no" for Patient 19 to indicate the patient had not returned to baseline and would have notified the anesthesia provider of the decreased oxygen saturation levels.

Based on record review and interview, the hospital failed to ensure the P&P for cleaning the air ducts in the ORs and special procedure rooms was approved by the hospital administrative management. In addition, the hospital failed to ensure the laminer airflow (an airflow system to filter out small bacteria-laden particles in the air coming into the OR) was functioning during an orthopedic surgical procedure. These created the risk of substandard health outcomes to the patients in the hospital.

Findings:

1. According to AAMI 2003, the Recommendation for Air-Handling Systems in Health-Care Facilities, showed the health-care facility to periodically measure output of monitor system function and clean ventilation ducts as part of routine HVAC maintenance to ensure optimum performance.

According to AORN 2010, the Recommended Practices for Environmental Cleaning in the Perioperative Setting, Recommendation V, showed all areas in the surgical practice setting should be cleaned according to an established schedule.

A cleaning schedule for areas that should be cleaned on a daily, weekly, or monthly basis should be established. The schedule should be developed by a multi-disciplinary team to determine appropriate cleaning and disinfection and maintenance frequencies. Ventilation ducts should be cleaned and filters changed on a regularly scheduled basis.

On 10/14/14 at 0825 hours, the Director and Assistant Director Facility Services were interviewed. The staff stated during an investigation of four SSIs from surgeries in the same OR room, OR 8, in May and June 2014, they were unable to locate documented evidence to show the maintenance or cleaning of the air ducts in OR 8 prior to July 2014.

The Facility department drafted a P&P for Facilities Management of HVAC Duct Cleaning; however, at this time the hospital's EOC Committee had not yet approved it.

2. Review of the hospital's documentation of the Surgical Site Quality Reported Events dated from 10/1/13 to 10/1/14, showed an event reported on 7/29/14 at 1320 hours, in OR 8, a laminar airflow room. Staff reported during a total joint surgery, the "Air was running into the room instead of out like a positive airflow room." The OR staff notified the maintenance by leaving a message. The following day the OR staff received a response from the Maintenance that the laminar airflow in OR 8 was not running in full capacity due to a booster fan malfunction.

Based on observation, interview, and record review, the hospital failed to ensure proper ventilation and temperature controls were maintained in the OR areas of the Mission Viejo and Laguna Beach campuses, the IR procedure room, and the Outpatient Endoscopy Center. In addition, there was no documentation to show a multidisciplinary team evaluated the new projects and the issues with ongoing renovation projects were communicated to the direct patient care staff in the affected areas. These failures created the risk of unsafe care to the patients in the hospital.

Findings:

1. Review of the hospital's P&P titled Facilities Management of Potential Airborne Pathogens, effective date of 1/1/12, showed temperature and humidity readings will be taken in all critical care areas to ensure the readings are within set ranges. The Power Plant Engineer will take these readings and documented time and date in the Daily Log Sheet. The temperature set point on all units should be adjustable by Plant Operations to a range of 62 to 80 degrees F. Normal setting will be 68 degrees F.

On 10/14/14 at 0825 hours, both the Director and Assistant Director Facility Services stated temperatures and humidity in the main ORs, IR, and LDR were checked and recorded only once a day prior to 7/28/14. The hospital changed the procedure to check and document temperatures and humidity to twice a day at 0700 and 1300 hours.

a. The Temperature and Humidity Log for the ORs on the Mission Viejo Campus were reviewed with the Director and Assistant Director Facility Services on 10/14/14 at 0825 hours.

* Documentation on 8/17/14 at 1300 hours, did not show the temperatures and humidity for all ORs (1-9) were documented as checked. The Directors stated they were not aware this monitoring was missed for that date.

* Documentation dated 10/5/14 at 0740 hours, showed the morning temperatures in OR 7 was 57 degrees F, OR 8 was 56 degrees F, and OR 9 was 59 degrees F.

Documentation in the area of the log for "Recheck if out of range" at 0800 hours, showed the temperatures in OR 7 was 61 degrees F, OR 8 was 63 degrees F, and OR 9 was 62 degrees F.

* Documentation of the temperatures in the OR at 1303 hours, showed OR 7 was 58 degrees F, OR 8 was 57 degrees F, and OR 9 was 59 degrees F. There was no documentation in the area of the log for "Recheck if out of range"

The Director Facility Services Facility was testing the function of a new air chiller unit installed in OR 8 during the time period of the low temperatures. Facilities was purposely manipulating the temperature in OR 8 to test if the temperature control worked.

A follow-up interview with the Clinical Director of Perioperative Services on 10/14/14 at 1305 hours, revealed the Director was not informed of the testing for the air chiller.

b. The Temperature and Humidity Log for the IR procedure rooms at the Mission Viejo Campus were reviewed with the Director and Assistant Director Facility Services on 10/14/14 at 0830 hours. The log showed from 8/13-8/16/14, the room temperature for the IR room at 0700 and 1300 hours, showed the temperatures ranged from 54-58 degrees F. There was no documented evidence on the log of interventions to adjust those out of range temperatures.

The Assistant Director stated he was aware of the discrepancies when he audited the documents. According to his investigation, the employee who checked the temperatures did not follow the standard procedure for obtaining the room's temperature. When asked, the Assistant Director confirmed all the previous temperatures monitored and recorded by that employee were potentially not accurate.

The Directors stated they did not inservice or confirm the competencies of their employees after the RCA until 8/16/14, when they identified the employee was not following procedure.

c. On 10/14/14 at 0825 hours, the OR Temporary Work Orders were reviewed with the Director and Assistant Director Facility Services. Documentation showed from July to October 2014, there was a frequent work order for to decrease and/or increase the room temperatures in OR 8 on the Mission Viejo Campus. However, this documentation did not show follow-up of the requests.

The Director stated the Facility department was aware of the issue of not able being able to demonstrate results after changes were made. The Directors stated Facility developed a new action plan to address the work flow more efficiently.

The Director stated the new Temperature/Humidity Process & Action Plan only allowed the Power Center (Facility) to adjust the temperatures according to the request, but there was no mechanism to receive a feedback from the clinical staff who made the request for change.

d. During a review of environmental control data for the Outpatient Endoscopy Center on 10/10/14 at 0940 hours, the data showed temperatures which were outside of the facility's goal range. The Procedure Room Temperature /Humidity Log for August 2014, read "Acceptable Temp Range 66-72 degrees F. Notify supervisor if outside of range."

Review of the log showed several temperatures were out of range, such as a temperature of 75 degrees F in room 1 and 74.3 degrees F on 8/29/14 in rooms 1 and 2, respectively. There was no documentation of any actions taken and no documentation to show the temperatures were rechecked.

During a concurrent interview with the Manager of the Endoscopy Center, she stated there was trouble regulating the temperature as it was an old building. The Manager stated the temperatures should be rechecked when they were out of range.

e. A random observation was conducted on 10/10/14 at 0945 hours, in OR 5 at the Laguna Beach Campus, accompanied by the OR Manager, RN 1, and RN 2. The OR's thermostat was observed with a temperature reading at 66 degrees F.

Temperature and humidity logs were requested for review. The OR Manager stated temperature was monitored centrally. The OR Manager stated the hospital followed AORN as a guideline of practice.

On 10/10/14 at 1005 hours, the Assistant Director 2 Facilities provided the DAILY CHECK AT 7:00 and & 1:00 PM and the Temperature and Humidity Log for the Laguna Beach Campus.

Review of the log from 10/6 to 10/9/14, showed the directions for temperature range to be between 68 to 75 degrees F. The normal setting would be 70 degrees F. Further review of the log showed the following:

* OR 1's temperature was 66 degrees F on 10/6/14 at 0700 hours and on 10/7/14 at 0700 hours, 67 degrees F on 10/8/14 at 0700 hours, and 66 degrees F on 10/9/14 at 0700 hours.

* OR 2's temperature was 64 degrees F on 10/6/14 at 0700 hours and on 10/7/14 at 0700 hours, 65 degrees F on 10/8/14 at 0700 hours, and 63 degrees F on 10/9/14 at 0700 hours.

* OR 3's temperature was 61 degrees F on 10/6/14 at 0700 hours, 10/7/14 at 0700 hours, 10/8/14 at 0700 hours, and 10/9/14 at 0700 hours.

* OR 4's temperature was 64 degrees F on 10/6/14 at 0700 hours and 10/7/14 at 0700 hours; and 65 degrees F on 10/8/14 at 0700 hours and 10/9/14 at 0700 hours.

* OR 5's temperature was 63 degrees F on 10/6/14 at 0700 hours, 65 degrees F on 10/7/14 at 0700 hours, 63 degrees F on 10/8/14 at 0700 hours, and 66 degrees on 10/9/14 at 0700 hours.

* OR 6's temperature was 60 degrees F on 10/6/14 at 0700 hours, 61 degrees F on 10/7/14 at 0700 hours, 63 degrees F on 10/8/14 at 0700 hours, and 64 degrees F on 10/9/14 at 0700 hours.

These forms showed OR staff was notified of the low temperatures; however, OR staff and the physicians did not want the temperatures between 68 and 75 degrees F.

On 10/10/14 at 1005 hours, the Assistant Director 2 Facilities stated there was no further action to follow up regarding the ORs' temperature.

The Assistant Director 2 Facilities stated the hospital's P&P for Facilities Management of Potential Airborne Pathogens was currently implemented. The hospital's P&P showed the normal range of temperature would be between 62 to 80 degrees F; a normal temperature setting would be 68 degrees F. However, the normal range of temperature directed on the Mission Hospital, Laguna Beach DAILY CHECK AT 7:00 am & 1:00 PM was between 68 to 75 degrees, not the same as the normal range of temperature from the hospital's P&P.

2. On 10/14/14 at 0825 hours, during an interview with Director and Assistant Director Facility Services, it showed the hospital had ongoing HVAC projects in ORs 7, 8, and 9. Review of the documentation of the meeting minutes for this project did not show the attendees included a clinical patient care staff member. When asked, the Director could not recall if the IC personnel evaluated the project.

On 10/14/14 at 1305 hours, during an interview, the Clinical Director of Perioperative Services stated the hospital would inform the her of the date and time the ORs were not available for surgery, but her staff was not a part of the OR HAVC project team.

3. Review of the hospital's documentation of the Surgical Site QREs dated from 10/1/13 to 10/1/14, showed an event reported on 7/29/14 at 1320 hours, in OR 8, a laminar airflow room. Staff reported during a total joint surgery, the "Air was running into the room instead of out like a positive airflow room." The OR staff notified the maintenance by leaving a message. The following day the OR staff received a response from the Maintenance that the laminar airflow in OR 8 was not running in full capacity due to a booster fan malfunction.

Based on observation, interview, and record review, the hospital failed to ensure a sanitary environment and an active program to prevent the spread of infections in accordance with the hospital's P&P and nationally recognized IC practices and guidelines as evidenced by:

1. The hospital failed to ensure there were sufficient numbers of qualified IC practitioners to develop and implement hospital IC policies and accomplish the tasks required for the IC program. Cross reference to A0748.

2. The hospital failed to have an effective system in place to develop, implement, and evaluate measures governing the identification, investigation, reporting, prevention, and control of infections and communicable diseases within the hospital. Cross reference to A0749.

3. The hospital failed to ensure the CEO, medical staff, and Chief Clinical and Nursing Officer implemented and maintained the IC program. Cross reference to A0756.

The cumulative effect of these systemic failures resulted in the hospital's inability to provide a safe and effective IC program.

Based on interview and record review, the hospital failed to ensure there were sufficient numbers of qualified IC practitioners to develop and implement hospital IC policies and accomplish the tasks required for the IC program. This created the risk of substandard health outcomes to the patients receiving services in the hospital.

Findings:

The Executive Director, Quality & Patient Safety was interviewed on 10/10/14 at 0850 hours. When asked, the Director stated there were no ICP RNs in the hospital today. The Director further explained a full-time ICP RN position was not budgeted for the IC Department until this FY, starting 7/1/14, when two full-time positions were created. The Director stated they filled one position and the RN was starting in the next week.

The Director stated the IC Department had consisted of several part-time RNs and the only remaining RN had been on a leave of absence since 9/4/14. The Director stated this RN only worked 2-3 days a week and was not certified in the speciality. The Director further stated at the present they had a corporate consultant assisting them in the IC program as well as an IC MD, MD 1.

The Director further stated the hospital noted a cluster of SSIs in May and June 2014. A RCA was held on 7/28/14, with staff involved and an action plan was put into place; however, there was insufficient follow-up with the action plan by the different departments involved, including the IC Department.

When asked if an individual IC RN was assigned to have oversight of IC activities in the surgical services area as well as the other patient care areas, the Director stated not one person was assigned to each area; the Manager of IC who resigned in September 2014, had overall responsibility. Staff RNs with an interest in IC were also assigned tasks, such as monitoring and collecting data on the use of central IV lines and urinary drainage catheters in their respective nursing units; however, the nurses did not have job descriptions or specialized training in an infection prevention role. When asked who analyzed the data, the Director stated the ICP MD.

During an interview with MD 1 on 10/13/14 at 1350 hours, the MD stated he was the Medical Director of the Infection Prevention Program. The MD further stated he was the advisor and met weekly with the IC team; he was also available for consultation and reviewed SSIs as well as other infections.

The MD stated the IC RN at this time was a consultant, present in the hospital two days a week. When asked if the hospital provided enough funds to support the IC Department, MD stated, "he would have to say no, in retrospect to where we are now." MD 1 stated they relied upon the managers and other personnel in the clinical areas to monitor IC practices.

When MD 1 was asked about the IC team's participation in the EOC rounds (inspections done in each department in the hospital twice a year) and their presence in the clinical units to see how care was delivered to patients, he stated, "we don't have enough personnel to do so."

When asked about the RCA held on 7/28/14, regarding a cluster of SSIs in May and June 2014, the MD stated he found documentation of sterilization information was missing and/or incomplete.



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The hospital's Infection Control Plan for 2014, showed "Hospital leaders will allocate needed resources for the Infection Prevention Program and provide systems to support infection prevention activities. In determining the number of Infection Preventionist and support staff, the organization considers patient census, characteristics of the patient population, and the complexity of the healthcare services to assure that resources are adequate to accomplish the task required for the infection prevention program."

During an initial interview with the IC Manager on 10/9/14 at 1205 hours, the part-time IC nurse working at the hospital three days per week was on leave and an outside IC Consultant RN was present in the hospital two days per week.

The Manager stated the previous IC Manager resigned on 9/2/14. The IC Manager stated she was not sure of the level of training of the IC personnel and had concerns regarding the inadequate number of staff performing IC duties. The Manager stated she was asked to fill the role of an IC Manager as she had training in inputting data, including data regarding infections into mandatory databases; however, she did not have special training in the IC program.

During an interview with the Clinical Director of Perioperative Services on 10/13/14 at 1510 hours, she stated she previously reported to the Manager of Infection Prevention or the Infection Prevention nurse; however, they were both now gone.

In an interview with MD 1, the IC Consultant on 10/13/14 at 1430 hours, he stated there was not enough IC staff to provide oversight of the IC practices in the hospital. MD 1 stated there was not enough time to complete the IC environment of care rounds.

During an interview with the Executive Director of Quality and Patient Safety on 10/13/14 at 1445 hours, she stated staff nurses on the nursing units performed infection prevention duties, such as monitoring for hand hygiene compliance, care of indwelling urinary drainage catheters, and central venous catheters; however, the nurses did not have job descriptions or specialized training in an infection prevention role.

Based on observation, interview, and record review, the hospital failed to have an effective system in place to develop, implement, and evaluate measures governing the identification, investigation, reporting, prevention, and control of infections and communicable diseases within the hospital as evidenced by:

1. Inadequate follow-up of issues identified in multiple areas during the investigation of four SSIs of Patients 24, 25, 26, and 27 who had hip and knee joint replacement surgeries in the same OR in late May to mid-June 2014. Each of the patients had infections with the same bacteria and required one to three follow-up surgeries due to infections.

2. There was no documentation to show a follow-up investigation by the IC Department of four abdominal SSIs for the surgeries in April, may, July and August 2014.

3. There was no documentation provided to three IC events reported by staff in the OR were investigated thoroughly and received a timely follow-up.

4. The hospital's corrective action for previously identified staff noncompliance with the High Level Disinfection process was a revision of a P&P to follow the manufacturer's recommendations and inservice staff for the revised P&P; however, the revised P&P was not reviewed and approved by the Infection Prevention Committee prior to implementation and contradicted another P&P which remained in place. Multiple deficient practices were observed by staff on both hospital campuses and in outpatient procedural areas.

5. Physician's failed to document a daily assessment for the continuation of a central IV catheter for four of 30 sampled patients (Patients 9, 10, 11, 12, and 21). This increased the potential for continuing an unnecessary catheter and increased infections.

6. In the Outpatient Endoscopic Center, there was no notation about actions taken when temperatures in the procedure rooms were not in acceptable range and no documentation the temperatures were rechecked and a black residue was noted on top of the procedure room supply cart when the room was terminally clean the night prior.

7. There was no documentation to show consistent surveillance of hand hygiene practices in all areas of the hospital.

8. Staff did not follow the manufacturer's directions for the wet time required after cleaning a blood glucose machine.

9. Three of six medical staff and allied health provider's credential files reviewed showed health information, such as TB testing, immunization, or flu vaccinations was missing from the files.

10. There was no documentation provided to show positive bacterial cultures were routinely reviewed by the Infection Prevention team.

11. Dialysis machines were not cleansed and disinfected properly at the Mission Veijo campus and bacteriological water testing of the machines was not brought to the EOC for review since June 2013.

12. Torn/worn patient care items were observed in the ORs of both the Mission Viejo and Laguna Beach campuses.

13. Staff in the SPD on the Mission Viejo campus did not follow the manufacturer's instructions to mix an enzymatic agent for the cleaning of used surgical instruments.

14. Medication cassettes in anesthesia carts were observed unclean with liquid residue, dust, and small pieces of trash.

These failures increase the risk of the spread of infections and communicable diseases in hospital patients.

Findings:

1. The Executive Director, Quality & Patient Safety was interviewed on 10/10/14 at 0850 hours. When asked, the Director stated there were no IC RNs present in the hospital today.

The Director stated the IC Department had consisted of several part-time RNs; the only remaining RN had been on a leave of absence since 9/4/14. The Director stated this RN only worked 2-3 days a week and was not certified in the specialty. The Director stated at the present, they had a corporate consultant assisting them in the IC program as well as an IC MD, MD 1.

The Director further explained a full-time ICP RN position was not budgeted for the IC Department until this FY, starting 7/1/14, when two full-time positions were created. The Director stated they filled one position and the RN was starting in the next week.

When asked if an individual IC RN was assigned to have oversight of the IC activities in the surgical services area as well as the other patient care areas, the Director stated not one person was assigned to each area; the IC Manager who resigned in September 2014, had overall responsibility. Staff RNs with an interest in IC were also assigned tasks, such as monitoring and collecting data on the use of central IV lines and urinary drainage catheters in their respective nursing units; however, the nurses did not have job descriptions or specialized training in an infection prevention role.

The Director further stated the hospital noted a cluster of SSIs in the Mission Viejo campus OR in May and June 2014. An RCA was held on 7/28/14, with the staff involved and an action plan was put into place; however, there were gaps and insufficient follow-up in implementing the action plan by different departments involved, including Perioperative Services and IC Department. The Director stated at this time, the hospital had voluntarily ceased performing elective surgeries and was in the process of retraining staff and auditing the RCA follow-up items to ensure compliance and completion.

During an interview with MD 1 on 10/13/14 at 1350 hours, the MD stated he was the Medical Director of the Infection Prevention Program. The MD further stated he was an advisor and met weekly with the IC team; he was also available for consultation and reviewed SSIs as well as other infections.

When MD 1 was asked about the IC team's participation in the EOC rounds (inspections done in each department in the hospital twice a year) and the team's presence in the clinical units to see how care was delivered to patients, he stated, "we don't have enough personnel to do so."

When asked about the RCA held on 7/28/14, regarding a cluster of SSIs in May and June 2014, the MD stated he found documentation of sterilization information was missing and/or incomplete.

The RCA held on 7/28/14, reviewed the SSIs of Patients 24, 25, 26, and 27 who had hip and knee joint replacement surgeries in OR 8 in late May to mid-June 2014. Each of the patients had infections with the same bacteria and required one to three follow-up surgeries due to infections.

In addition, the team developed a Fishbone diagram (a cause and effect diagram that can help in brainstorming to identify possible causes of a problem and in sorting ideas into useful categories. A fishbone diagram is a visual way to look at cause and effect. The problem or effect is displayed at the head or mouth of the fish. Possible contributing causes are listed on the smaller "bones" under various cause categories. The diagram is helpful in identifying possible causes for a problem that might not otherwise be considered by directing the team to look at the categories and think of alternative causes).

Review of the RCA dated 7/28/14, showed 11 areas were reviewed and issues were identified with potential problems, including out of range temperature and humidity levels in the OR; the OR ventilation system; IUSS; sterile processing of instruments; sterilization of loaner instruments; cleaning of the OR between cases; terminal cleaning of the ORs, gurneys at the end of the day, surgical attire, and personal equipment brought in to OR rooms; communication; and future projects.

a. The Clinical Director of Perioperative Services was interviewed on 10/13/14 at 1500 hours. The Director stated issues with IUSS and tracking were identified prior to June 2014. The Director stated the system staff used was not efficient. The hospital identified gaps in compliance and staff was educated in June 2014; however, they had personnel issues in the SPD and there were gaps in practice following the RCA. Presently, competencies were being reviewed and audited daily.

b. The 2014 EOC Rounds schedule for the Mission Viejo campus was provided for review. Surgical Services were scheduled for rounding on 3/11 and 9/9/14 at 0900 and 1000 hours. Audit tools used for the OR included Infection Prevention (including confirmation humidity levels were monitored), Life Safety (fire safety), Medical Equipment, Utilities (including review of temperature/humidity log), Emergency Management, Security, and Hazmat.

The 7/28/14 RCA for the SSIs showed EOC rounds were "somewhat ineffective" due to a "young committee" and timing of when rounds were completed. The action needed showed action plans and findings would be monitored through the EOC committee and responded through the Quality of Care committee at the September 2014 meeting.

During an interview with the Director of Clinical Perioperative Services on 10/13/14 at 1335 hours, she stated the Executive Director of Quality and Patient Safety received the IC EOC rounds data and forwarded it.

The Environment of Care Quality of Care Report dated March 3, 2014, was reviewed on 10/13/14. The report contained sections for safety injuries, hazardous materials and waste, security, fire/life safety, medical equipment, utility systems, and emergency management, but there was no section for data on infection prevention and control.

The EOC Committee's minutes for the monthly meetings from 1/28/14 to 7/29/14, were reviewed. The minutes contained a section for infection prevention. The minutes for each of the monthly meetings contained the exact same wording.

In the column for discussion/synopsis: "Infection Prevention Audits - A report is generated and sent to every manager and involved departments such as EVS, Facilities, NCS, etc. Need feedback as to the status of non-compliant issues" was written.

Under the column action: "..This continues to be a non-compliant issue. (Executive Director of Quality) to address in the huddle" was written.

Under the column for status: "ongoing" was written.

There were no specific infection prevention EOC findings and no specific planned actions were documented.

During an interview with the Director of Clinical Perioperative Services on 10/13/14 at 1335 hours, she concurred the IC section of the EOC meeting minutes appeared incomplete and stereotyped.

Further review of the Quality of Care meeting minutes showed documentation the September 2014 meeting to address issues in the RCA follow-up was not held due to another hospital issue.

The RCA action plan recommended the EOC audit tools/questions be modified to assess each of the gaps identified in the RCA and be conducted monthly from August through October 2014, then every other month. In addition, it was recommended the rounds be conducted when the ORs were assessable (non-peak surgery times).

The results of the 2014 EOC rounds were requested for review. Review of the documentation showed EOC rounds were conducted by Infection Prevention in surgical services on 1/31 and 3/27/14, but no time of day was documented. The questions were answered as yes/no; however, there was no documentation to show which of the ORs were observed or how many staff were observed/questioned regarding practices.

During an interview with the Director of Facilities on 10/14/14, the Director was asked to provide documentation of the EOC rounds conducted monthly following the 7/28/14 RCA for the SSIs as shown in the follow-up action plan. The Director stated there was no documentation to show EOC rounds were conducted after the RCA.

The Executive Director for Quality and Patient Safety was interviewed on 10/14/14 at 1445 hours. The Director confirmed there was no follow-up by the IC personnel with EOC rounds in surgical services as per the RCA action plan. When asked if the audit tools were modified to capture the gaps in practice identified in the RCA, the Director stated, "no."

The Director was asked about the generality of the EOC rounds documentation. The Director stated they were aware of this. The RN who conducted the rounds resigned last spring.

c. The RCA team identified temperature and humidity was not consistently monitored and controlled. Cross reference to A0726, example #1.

The Director and Assistant Director of Facilities were interviewed on 10/14/14 at 0820 hours. Both staff confirmed issues with temperature and humidity were identified during the 7/28/14 RCA as potential causes for the SSIs. The staff stated one issue they identified was the practice for the facilities staff to monitor the levels only one time per day at 1600 hours. They stated after the RCA, monitoring of the OR temperatures was changed to twice a day at 0700 and 1300 hours.

The Temperature and Humidity log for 8/17/14 at 1300 hours, was reviewed with the Directors. There was no documentation of the temperature and humidity for all ORs 1-9. The Directors stated they were unaware of the gap in the log for that day.

In addition, the log showed from 8/13-8/16/14, the room temperature for the IR room at 0700 and 1300 hours, showed the temperatures ranged from 54-58 degrees F. There was no documented evidence on the log of interventions to adjust those out of range temperatures.

The Assistant Director stated he was aware of the discrepancies when he was auditing the documents. According to his investigation, the employee who checked the temperatures did not follow the standard procedure for obtaining room temperatures. When asked, the Assistant Director confirmed all the previous temperatures monitored and recorded by that employee were potentially not accurate.

The Directors stated they did not inservice or confirm the competencies of their employees after the RCA until 8/16/14, when they identified the employee was not following procedure.

The Director stated there was no QA for temperature or humidity prior to the RCA. The issues identified by facilities staff were not a part of any report to the IC Department.

d. During an interview on 10/14/14 at 0820 hours, the Director and the Assistant Director of Facility stated from March 2014, there was an ongoing project for improving HVAC services to ORs 7, 8, and 9. The project included to install chill water units to decrease the OR temperatures to 62-65 degrees (the code is for 68-75 degrees). ORs 8 and 9 were utilized for orthopedic cases and were designed for laminar airflow (an airflow system to filter out small bacteria-laden particles in the air coming into the OR).

The project involved removing all the existing duct work, lighting, and ceiling for installation of the units. The Director provided documents to show meeting minutes regarding the project from March and May 2014. The Director also stated there was no documentation to show the air ducts in ORs 8 and 9 were cleaned until July 2014. Review of the project meeting documentation did not show the attendees included a clinical care staff. When asked, the Director could not recall if the IC personnel had involved the project. A documentation documented on 9/26/14, the IP was approved the project.

During a tour of the Mission Viejo Surgical Services on 10/10/14 at 0900 hours, the OR Manager stated OR 8 was specifically utilized for orthopedic joint surgeries as the room had a Laminar Air system.

Review of the hospital's documentation of the Surgical Site QREs dated from 10/1/13 to 10/1/14, showed an event reported on 7/29/14 at 1320 hours, in OR 8, a laminar airflow room. Staff reported during a total joint surgery, the "Air was running into the room instead of out like a positive airflow room." The OR staff notified the maintenance by leaving a message. The following day the OR staff received a response from the Maintenance that the laminar airflow in OR 8 was not running in full capacity due to a booster fan malfunction.

The OR staff documented the patients who had total joint surgery on 7/28 and 7/29/14, should be observed for possible infection. Documentation dated 7/31/14, showed the hospital's IC Consultant MD was informed of the events. The IC Consultant recommended notifying the patients' surgeon(s).

Additional follow-up documentation dated 10/11/14, recommended the IC Practitioner to follow up with the patients for a possible SSIs; however, there was no documented evidence the recommendations were followed through.

2. The hospital's Infection Control Plan for FY2014 dated 7/2013, showed surveillance activities were to include monitoring of "All surgical site infections to determine if there are clusters of infections related to surgeon, service, pathogens, product, etc."

During an interview with the Clinical Director of Perioperative Services on 10/13/14 at 1335 hours, she stated for post-operative infections, the Perioperative Services nurse reviewed the medical records of patients with SSIs and sent it to Infection Prevention, where the follow-up occurred.

Four abdominal SSIs were reviewed. The Current Summary sheet for each infection showed the incidents dated to surgeries on 4/23/14 (detected 5/9/14), 5/17/14, 7/17/14 and 8/27/14, were discussed in a meeting on 9/16/14. There was documentation of a discussion with the IC Consultant; however, there was no documentation of a follow-up investigation by the IC Department. There was a note on each file indicating the files were assigned for additional review.

During an interview with the Executive Director of Quality and Patient Safety on 10/14/14 at 1600 hours, she stated she was not sure whether the three abdominal infection cases were reviewed as yet or if the abdominal infection case detected in May 2014 was referred for review.

In an interview with the IC Consultant, MD 1 on 10/13/14 at 1340 hours, he stated in some cases the causes of SSIs were not re-examined.

3. Review of the hospital's QRE documentation showed the following three incidents were reported by staff in the main OR of the Mission Viejo campus:

a. On 8/8/14, in an unknown OR, a large fly was seen in the room during a surgical procedure.

There was no follow-up until 10/11/14, when the OR Manager documented the patient was administered antibiotics. The plan was to ensure the bug light was in good working order and new signs were placed in the PACU to the OR to decrease the foot traffic going through the trauma door.

There was no documentation of an investigation or follow-up at the time of the survey exit date on 10/14/14.

b. On 8/16/14, in an unspecified OR room, a surgical instrument already placed on the ongoing surgical sterile field was noted as not cleaned properly before sterilization.

There was no documentation provided to show an investigation or follow-up of the incident at the time of the survey exit on 10/14/14.

c. On 8/29/14, during a surgery, an insect dropped from the ceiling on to the sterile field.

Documentation dated 9/3/14, showed the surgeon was aware and the patient received extensive antibiotics for treatment.

The issue was addressed with external treatment of the area by an extermination company. Documentation showed the OR environment was inspected and repair work completed to seal the gaps behind the sterilizers.

Documentation dated 10/11/14, confirmed the patient was covered with extensive antibiotics and the Director of Integrated Services was notified.

There was no documentation of an investigation or follow-up of the patient's condition at the time of the survey exit on 10/14/14.


4. According to the Basics of Infection Prevention 2013, Cleaning, Disinfection, and Sterilization, presented by the California Department of Public Health and APIC's practice standards are based on Spaulding's Classification system. Healthcare devices and equipment are designated as Critical, Semi-critical, and non-critical. The categories define the level of reprocessing required. Semi-Critical Items such as respiratory therapy equipment, anesthesia equipment, flexible laryngoscopes, bronchoscopes, GI endoscopes, cystocopes, and vaginal ultrasonic probes require a minimum of HLD or sterilization. This includes items in contact with non-intact skin or mucous membranes.

On 10/9/14 at 1200 hours, during an interview, the Executive Director of Quality and Patient Safety stated the hospital previously identified noncompliance with the HLD process in patient care services. The hospital's corrective action included to revise the P&P according to the manufacturer's recommendations and inservice staff for the revised P&P.

On 10/10/14, the P&P for HLD in the hospital was requested. Two different P&Ps were received.

Review of the hospital's P&P titled Disinfection: High Level, effective date of 5/1/12, showed the procedure for HLD using Cidex OPA (Ortho-phthalaldehyde) included:
- Only Cidex OPA solutions, effective for 14 days, will be used.
- Solution will be checked daily before use (on days of use) for effectiveness.
- Solution must be discarded when no longer effective, or on the 14th day of use. In no situation will the solution be used longer than 14 days.
- Instrument must be rinsed well after high level disinfection. After 12 minutes immersion in Cidex OPA, rinse instrument three times for one minute each time by immersing in water.

The section of endocavity ultrasound instrument included:
- To see the above section for HLD.
- Immerse probe in Cidex OPA for a minimum of 12 minutes.
- Instrument must be rinsed well three times after HLD with sterile water.

The P&P showed all solutions/systems used to process endoscopes and endocavity probes will be approved by the Infection Prevention Committee prior to use and competency of personnel processing the equipment will be assessed at least annually.

There was no documentation on the P&P to show approval by the IC Committee and the "Committee Review" area on the P&P was left blank.

Review of the second P&P was the revised Disinfection of Transducer of the Image Services last dated 4/12, for disinfection of dirty transducers (a hand held device that sends and receives ultrasound signals) showed the process was to remove the probe from the Cidex after a 12 minute immersion, rinse with tap water and dry with a clean towel.

For disposal and change of the Cidex solution (a highly acidic solution) used to disinfect vaginal probes, showed to pour one bottle (30 cc) of Glycinex powder into one quart of Cidex OPA, wait for 15 minutes or until the solution turns black, indicating complete neutralization of the acid. Dispose of the neutralized solution down the drain, flushing with water.

This P&P was inserviced to the staff on 10/09/14. The "Approval" area of this P&P was also left blank. The P&P showed only the Manger of Diagnostic Radiology approved the P&P.

On 10/10/14 at 0855 hours, the Chief Clinical and Nursing Officer reviewed the two P&Ps. The Nursing Officer stated she was not aware of the discrepancies between the HLD P&P and the Disinfection of Transducer P&P for rinsing of the probes after immersion in Cidex.

The following were observations of the use of HLD in several areas of both hospital campuses and outpatient areas.

a. The endoscope processing system in the Outpatient Endoscopy Center was observed on 10/10/14 at 0915 hours. During an interview with Surgical Tech 1 on 10/10/14 at 0900 hours, she stated as part of the endoscope cleaning process, she checked the temperature of the chemical disinfectant before processing. The Tech then provided the temperature log which showed the temperatures of the disinfectant ranged from 36.0 degrees C to 38.5 degrees C.

The temperatures recorded on the disinfectant machine printouts accompanying processed scopes were reviewed. The disinfectant temperatures at the time of processing were 37 to 38 degrees C for two scopes.

Review of the manufacturer's Instructions for Use of the disinfectant showed it was to be maintained at 35 degrees C. A Product Bulletin dated February 21, 2011, from the disinfectant's manufacturer showed the temperature on the reservoir of disinfectant should be adjusted to assure a disinfection basin temperature of 35 degrees C.

During an interview via phone with the manufacturer's representative on 10/10/14 at 0915 hours, he stated he believed the chemical disinfectant should be maintained between 35 and 42 degrees C; however, he was unable to provide documentation of approved use above 35 degrees C.

During an interview with the Manager of the Outpatient Endoscopy Center on 10/10/14 at 1230 hours, she concurred she was unable to find documentation indicating the disinfectant could be used at a temperature above 35 degrees C.

b. On 10/9/14 at 1315 hours, the Women's Wellness Center was toured. In Ultrasound Exam 2, an opened bottle of testing strips for Cidex OPA was observed with no date to show when the bottle was opened. The instructions on the Cidex OPA test strips were to date the opened bottle and discard after 90 days (to ensure the strips were accurate).

In Ultrasound Exam 3, Ultrasound Tech 3 stated the department had a schedule to change the Cidex disinfectant every two weeks. Before emptying the Cidex solution from the container, Ultrasound Tech 3 opened a package of Glycinex powder (a 2 oz package) and added an unmeasured amount of the powder to the Cidex OPA, waited for a short time, and when the color of the Cidex changed to dark orange/brown, the solution was dumped in the regular hand wash sink and flushed with running water.

However, review of the print information on the Glycinex package showed for one gallon of 0.55% Cidex OPA, the deactivation time was five minutes. The package did not give specific instructions for the amount of Glycinex powder needed for deactivation. When asked, the hospital was unable to provide manufacturer's instructions for use of the Glycinex prior to the exit date of the survey on 10/14/14.

c. An interview was conducted with Ultrasound Technician 2 on 10/10/14 at 1120 hours at the Laguna Beach Campus. The Ultrasound Technician was asked about the process of cleaning and disinfecting the endocavity ultrasound probe. The Ultrasound Technician stated she used a Super Sanicloth to wipe a used endocavity ultrasound probe, rinsed with tap water, checked the temperature to make sure the temperature was 68 degrees, put the used endocavity ultrasound probe into a container containing Cidex for 12 minutes, rinsed the endocavity ultrasound probe with tap water, put the endocavity ultrasound probe into a container of water for three minutes, cleansed and dried the disinfected endocavity ultrasound probe, and hung it up.

The Technician was asked for the hospital's P&P for the process of cleaning and disinfecting the endocavity ultrasound probe. Technician 2 provided the hospital's P&P titled Disinfection of Transducer, draft issued on 10/7/14, that was unsigned. The Ultrasound Technician stated that was the hospital's P&P currently implemented.

Review of the hospital's P&P titled Disinfection of Transducer, draft issued on 10/7/14, showed to soak the probe for a minimum of 12 minutes in Cidex OPA; remove the probe from Cidex OPA, rinse with tap water and dry with clean towel.

The hospital's P&P for Disinfection of Transducer was not developed in in accordance to the hospital's P&P for Disinfection: High Level and was unsigned.

During an interview and documentation review with the Vice President of Operations on 10/10/14 at 1430 hours, the Vice President confirmed the hospital's P&P titled Disinfection of Transducer was a draft issued on 10/7/14, and was unsigned.

d. Review of the Endocativy Probe, Cidex Disinfection Log(s) at the Laguna Beach Campus on 10/10/14 at 1120 hours, with Ultrasound Technician 2 showed the following:

* On 9/9/14, a used endocavity probe was soaked in the Cidex solution for two minutes (from 1440 to 1442 hours).
* On 9/15/14, a used endocavity probe was soaked in the Cidex solution for seven minutes (from 1430 to 1437 hours).
* On 9/27/14, a used endocavity probe was soaked in the Cidex solution for ten minutes (from 1415 to 1425 hours).

Ultrasound Technician 2 confirmed the log did not show the used endocavity probes were soaked in the Cidex solution for 12 minutes as per hospital's P&P.

Concurrent review of documentation of the changing of the Cidex solution and the Endocativy Probe, Cidex Disinfection Log(s) with Ultrasound Technician 2 showed the following:

* The Cidex solution was changed on 7/3 and again 7/21/14, the 18th day, and not in 14 days as per the hospital's P&P. However, the Cidex solution was used to disinfect used endocavity probes on the 16th day (7/19/14) and on the 17th day (7/20/14).

* The Cidex solution was changed on 9/5 and again on 9/22/14. The Cidex solution was changed on the 17th day, not in the 14 days as per hospital's P&P. However, the Cidex solution was used to disinfect a used endocavity probe on the 15th day (9/20/14).

Ultrasound Technician 2 verified the findings.

Review of the hospital's P&P titled Disinfection: High Level effective date 5/1/12, showed competency of personnel processing the equipment will be assessed at least annually.

Review of Ultrasound Technician 2's personnel file was conducted on 10/14/14 at 1010 hours, accompanied by the Vice President - Human Resource. The Ultrasound Technician's personnel file failed to show competency for processing endocavity probes was evaluated annually. The Vice President was asked for documentation to show when the Ultrasound Technician was last evaluated for competency for disinfecting or processing endocavity probes.

On 10/14/14 at 1315 hours, the Vice President - Human Resource provided the On-Going Competency Assessment Form showing Ultrasound Technician 2 was evaluated for competency for disinfection of endocavity probes on 10/12/14, two days prior. The Vice President stated staff's competency should be evaluated annually; however, she was unable to find documentation to show Technician 2 was evaluated for competency for disinfecting or processing endocavity probes prior to 10/12/14.

e. Review of the hospital's P&P titled Disinfection: High Level effective date 5/1/12, showed endoscopes must be stored in a manner that will protect them from contamination and damage while minimizing the potential for accumulation of residual moisture. Flexible endoscopes are to be hung in a separate, designated storage closet.

An observation was conducted on 10/10/14 at 1045 hours in the GI area of the Laguna Beach Campus, accompanied by RN 3. An endoscope was observed stored in the scope storage cabinet hung curled up not in a vertical position. The RN confirmed the finding.

f. An observation was conducted on 10/14/14 at 0810 hours in the cardiology area of the Mission Viejo Campus, accompanied by the Administrative Director for Clinical Services. One scope used for TEE (Transesophageal echocardiography. A diagnostic test which employs ultrasound waves to make images of the heart chambers, valves and surrounding structures and which is done through the esophagus) was observed stored in the horizontal position in a container. Two other scopes used for TEE were observed hung straight down in a vertical position in the scope storage. The Administrative Director for Clinical Services confirmed the observations. The Administrative Director for Clinical Services stated it was ideal to store the scope straight down.

g. The manufacturer's recommendations for Enzol Enzymatic Detergent showed to add one ounce of Enzol Enzymatic Detergent per gallon of water and soak the instruments immediately after use until all organic matter is removed. A minimum soak of one minute was recommended. For equipment with dried-on matter, extend the soak time, using two ounces per gallon of water an/or use warm water.

Review of the hospital's P&P titled TD 100 TEE probe Sterilizer effective date 8/15/12, showed a soiled probe to be cleaned and rinsed of all protein utilizing six pumps of Endozyme Cleaner.

During an observation in the cardiology area at the Mission Viejo Campus on 10/14/14 at 0810 hours, Echo Technician 1 stated he mixed one or two pumps of Enzol to a basin filled with water. Technician 1 stated he filled to water to the line "5" on the basin, or one gallon water. Technician 1 was asked how he knew one gallon of water filled up to that line. Technician 1 stated he tested it when he first came to work.

Technician 1 was asked to demonstrate whether one gallon water filled up to that line. The Technician added 5000 ml water (3785 ml = 1 gallon) to fill to the line "5" of the empty basin. Technician 1 then added 4500 ml water to fill up to the line "5" of the basin containing the TEE scope. When asked, Technician 1 confirmed the manufacturer's recommendat

Based on observation and interview, the hospital failed to ensure the CEO, medical staff, and Chief Clinical and Nursing Officer implemented and maintained the IC program as evidenced by:

1. Failed to ensure the availability of trained staff capable of carrying out the effective IC program.

2. Failed to ensure the provision of resources required to carry out the IC plan.

These failures created the increased risk of infections and spread of diseases in the hospital

Findings:

The hospital's Infection Control Plan for 2014, showed "Hospital leaders will allocate needed resources for the Infection Prevention Program and provide systems to support infection prevention activities. In determining the number of Infection Preventionist and support staff, the organization considers patient census, characteristics of the patient population and the complexity of the healthcare services to assure that resources are adequate to accomplish the task required for the infection prevention program."

1. During an initial interview with the IC Manager on 10/9/14 at 1205 hours, the part-time IC nurse working at the hospital three days per week was on leave; an outside IC consultant RN was present in the hospital two days per week.

The Manager stated the previous IC Manager resigned on 9/2/14. The IC Manager stated she was not sure of the level of training of the IC personnel and had concerns regarding the inadequate number of staff performing IC duties. The Manager stated she was asked to fill the role of an IC Manager as she had training in inputting data, including data regarding infections into mandatory databases; however, she did not have special training in the IC program.

The Executive Director, Quality & Patient Safety was interviewed on 10/10/14 at 0850 hours. When asked, the Director stated there were no IC RNs in the hospital today. The Director further explained a full-time IC RN position was not budgeted for the IC Department until this FY, starting 7/1/14, when two full-time positions were created. The Director stated they filled one position and the RN was starting in the next week.

The Director further stated the hospital noted a cluster of SSIs in May and June 2014. A RCA was held on 7/28/14, with staff involved and an action plan was put into place; however, there was insufficient follow-up with the action plan by the different departments involved, including the IC Department.

When asked if an individual IC RN was assigned to have oversight of IC activities in the surgical services area as well as the other patient care areas, the Director stated not one person was assigned to each area; the IC Manager who resigned in September 2014, had overall responsibility. Staff RNs with an interest in IC were also assigned tasks, such as monitoring and collecting data on the use of central IV lines and urinary drainage catheters in their respective nursing units; however, the nurses did not have job descriptions or specialized training in an infection prevention role. When asked who analyzed the data, the Director stated the IC MD.

During an interview with the Clinical Director of Perioperative Services on 10/13/14 at 1510 hours, she stated she previously reported to the Manager of Infection Prevention or the Infection Prevention nurse; however, they were both now gone.

In an interview with MD 1, the IC Consultant on 10/13/14 at 1430 hours, he stated there was not enough IC staff to provide oversight of the IC practices in the hospital. MD 1 stated there was not enough time to complete IC EOC rounds.

During an interview with the Executive Director of Quality and Patient Safety on 10/13/14 at 1445 hours, she stated staff nurses on the nursing units performed infection prevention duties, such as monitoring for hand hygiene compliance, care of indwelling urinary drainage catheters, and central venous catheters; however, the nurses did not have job descriptions or specialized training in an infection prevention role.

During an interview with RN 9 on 10/13/14 at 1350 hours, the RN stated she was designated to monitor for IC for the Medical Surgical Oncology unit. The RN stated she monitored care of indwelling urinary drainage catheters and central venous catheters by observations of those patients and reported her data to the IC task force which met every other month.

RN 9 stated she had not been asked to put an action plan into place in regards to her findings as yet. When asked the training she received prior to beginning her role, RN 9 stated the RN in the role prior to her trained her.

2. A review of the Quality of Care reporting calendar for 2014, showed the Infection Prevention Department was to report to the committee in January and June 2014.

During a review of the Quality of Care agenda for the 6/5/14, meeting showed the agenda included a report on Service Control Line Quality Improvement & Strategic Control Planning Program and Measures by the IP. However, bold type on the bottom of the agenda indicated the meeting was canceled at the request of the Chief Clinical and Nursing Officer.

During an interview with the Chief Clinical and Nursing Officer on 10/13/14 at 0930 hours, she stated nurses from each nursing unit were on the infection prevention subcommittee but thought the subcommittee was probably not meeting. The Nursing Officer stated the Quality of Care for June 2014, was canceled because staff was dealing with other pressing issues.

A Proposal for the Infection Prevention Team dated January 2014, by the previous Infection Prevention Manager showed a proposal to reduce hospital acquired infections and increase hand hygiene compliance. The proposal showed hand hygiene compliance rates of 43% for staff before entering a patient room, 68% for staff upon leaving the room at the main hospital campus, and 50% for staff before entering and 62% for staff after exiting at the Laguna Beach campus. The proposal included using unit based nurses who would receive pay for training, meetings, and tasks.

During an interview with the Executive Director of Quality and Patient Safety on 10/14/14 at 1435 hours, she stated a hand hygiene monitoring proposal was made by the previous Infection Prevention Manager; however, the program was not funded.

During an interview with the Chief Clinical and Nursing Officer on 10/13/14 at 0930 hours, she stated she was not sure if it was okay no hand hygiene audits were done in the Endoscopy Center from 5/31/13, until the date of the interview on 10/13/14. The Nursing Officer stated the hand hygiene data and information on central line infections was to be presented at the Nursing Quality Council, which presented to the Coordinating Council, and that she sat on the Coordinating Council. However, the Nursing Officer stated she provided no oversight of IC functions in the hospital. The Nursing Officer stated the IC practitioners were to do hand hygiene audits, but since IC staff were on leave or resigned, she was not sure who was coordinating hand hygiene audits. The Nursing Officer stated nurses from each unit were on the infection prevention subcommittee but thought that the subcommittee was probably not meeting.

Based on observation, interview, and record review, the hospital failed to ensure surgical services were well organized and provided in accordance with acceptable standards of practice to ensure the health and safety of patients as evidenced by:

1. Failure to ensure adverse events, such as surgical site infections were integrated into the hospital-wide QAPI program and formed the basis for learning and improvement of services, creating the risk of persistent poor practices and substandard healthcare. Cross reference to A0308, example #1.

2. Failure to ensure proper ventilation and temperature controls were maintained in the surgical services areas of the Mission Viejo and Laguna Beach campuses and the Outpatient Endoscopy Center. In addition, there was no documentation to show a multidisciplinary team evaluated the new projects and the issues with ongoing renovation projects were communicated to the direct patient care staff in the affected areas. Cross reference to A0726.

3. Failure to ensure EOC rounds were conducted in conjunction with the IC personnel in the surgical services area at least monthly to address issues identified as potential causes of a cluster SSIs, including out of range temperature and humidity levels in the OR; the OR ventilation system; IUSS; sterile processing of instruments; sterilization of loaner instruments; cleaning of the OR between cases; terminal cleaning of the ORs, gurneys at the end of the day, surgical attire, and personal equipment brought in to OR rooms; communication; and future projects. Cross reference to A0749, example #1.

4. Failure to provide a safe and effective environment and maintain high standards of care for the patients receiving surgical services. Cross reference to A0951.

The cumulative effect of these systemic practices resulted in the hospital's inability to provide safe and effective surgical services.

Based on observation, interview, and record review, the hospital failed to provide a safe and effective environment and maintain high standards of care for the patients receiving surgical services as evidenced by:

1. Failure to ensure EOC rounds were conducted in conjunction with the IC personnel in the surgical services area at least monthly as recommended in the action plan to address a cluster SSIs identified.

2. Failure to implement hospital P&P to ensure a piece of equipment brought in and used by a physician in procedures at the Outpatient Endoscopy Center was checked for proper functioning prior to use.

3. Failure to ensure proper ventilation and temperature controls were maintained in the surgical services areas of the Mission Viejo and Laguna Beach campuses and the Outpatient Endoscopy Center. Cross reference to A0726.

These failures created the risk of substandard healthcare associated with the provision of surgical services to the patients in the hospital.

Findings:

1. The Executive Director, Quality & Patient Safety was interviewed on 10/10/14 at 0850 hours. The Director stated the hospital identified a cluster of SSIs in the Mission Viejo campus OR in May and June 2014. An RCA was held on 7/28/14, with the staff involved to examine practices and an action plan was put into place; however, there were gaps and insufficient follow-up in implementing the action plan by the different departments involved, including Perioperative Services. The Director stated at this time, the hospital had voluntarily ceased performing elective surgeries and was in the process of retraining staff and auditing the RCA follow-up items to ensure compliance and completion.

The RCA held on 7/28/14, reviewed the SSIs of Patients 24, 25, 26, and 27, who had hip and knee joint replacement surgeries in OR room 8, late May to mid-June 2014. Each of the patients had infections with the same bacteria and required one to three follow-up surgeries due to infections.

Review of the RCA dated 7/28/14, showed 11 areas were reviewed and issues were identified with potential problems, including out of range temperature and humidity levels in the OR; the OR ventilation system; IUSS; sterile processing of instruments; sterilization of loaner instruments; cleaning of the OR between cases; terminal cleaning of the ORs, gurneys at the end of the day, surgical attire, and personal equipment brought in to OR rooms; communication; and future projects.

The 7/28/14 RCA for the SSIs showed EOC rounds were "somewhat ineffective" due to a "young committee" and timing of when rounds were completed. The action needed showed action plans and findings would be monitored through the EOC committee and responded through the Quality of Care committee at the September 2014 meeting.

The RCA action plan recommended the EOC audit tools/questions be modified to assess each of the gaps identified in the RCA and be conducted monthly from August through October 2014, then every other month. In addition, it was recommended the rounds be conducted when the OR rooms were assessable (non-peak surgery times).

During an interview with the Clinical Director of Perioperative Services on 10/13/14 at 1335 hours, she stated the Executive Director of Quality and Patient Safety received infection control environment of care rounds data and forwarded it.

During an interview with MD 1 on 10/13/14 at 1350 hours, the MD stated he was the Medical Director of the Infection Prevention Program. When MD 1 was asked about the IC team's participation in the EOC rounds (inspections done in each department in the hospital twice a year) and the team's presence in the clinical units to see how care was delivered to patients, he stated, "we don't have enough personnel to do so."

Review of the Quality of Care meeting minutes showed documentation the September 2014 meeting to address issues in the RCA follow-up was not held due to another hospital issue.

Review of the hospital's QRE documentation showed the following three incidents were reported by staff at the main OR of the Mission Viejo campus following the 7/28/14 RCA:

* On 7/28 and 7/29/14, two separate reports were made to facilities that the laminar airflow was not running at full capacity in OR 8, not creating a full positive airflow. The two patients in the room were undergoing total joint surgeries.

* On 8/8/14, in an unspecified OR room a large fly was seen in the room during a surgical procedure.

* On 8/16/14, in an unspecified OR room, a surgical instrument already placed on the ongoing surgical sterile field was noted as not cleaned properly before sterilization.

* On 8/29/14, during a surgery an insect dropped from the ceiling on to the sterile field.

The results of the 2014 EOC rounds were requested for review. Review of the documentation showed EOC rounds were conducted by Infection Prevention in surgical services on 1/31 and 3/27/14, no time of day was documented.

During an interview with the Director of Facilities on 10/14/14, the Director was asked to provide documentation of the EOC rounds conducted monthly following the 7/28/14 RCA for the SSIs as shown in the follow-up action plan. The Director stated there was no documentation to show EOC rounds were conducted after the RCA.

The Executive Director for Quality and Patient Safety was interviewed on 10/14/14 at 1445 hours. The Director confirmed there was no follow-up by the IC personnel with EOC rounds in surgical services as per the RCA action plan. When asked if the audit tools were modified to capture the gaps in practice identified in the RCA, the Director stated, "no."

During an interview with the CEO on 10/14/14 at 0840 hours, he stated the managers of each department had measurable quality goals; however, the CEO stated staff was delayed in producing the data about performance due to work load.

During an interview with the Executive Director of Quality and Patient Safety on 10/10/14 at 1525 hours, she stated the SCIP measures were the only measures presented for surgery. She stated the RCA of the orthopedic surgical site infections were presented to the Perfect Care Committee on 4/2014 and 10/2014.


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2. The hospital's P&P titled Receipt of Loaner Instrumentation, effective date of 6/1/12, read in part, "Check instruments for proper function. Document problems ..."

During a review of the High Level Disinfectant Bin Cleaning Log for the Outpatient Endoscopy Center on 10/10/14, the log showed the staff processed the manometer (instrument for measuring pressure) belonging to MD 3 six times in June 2014; four times in July 2014; three times in August 2014; and five times in September 2014.

The Manager of the Endoscopy Center stated in an interview on 10/10/14 at 0930 hours, MD 3 performed manometry of the esophagus using his own manometer which was cleaned in the facility prior to use. When asked about the calibration of the manometer, the Manager stated the physician did his own calibration of the equipment and she did not have a copy of the calibration.

3. The hospital failed to ensure proper ventilation and temperature controls were maintained in the OR areas of the Mission Viejo and Laguna Beach campuses, the IR procedure room, and the Outpatient Endoscopy Center. In addition, there was no documentation to show a multidisciplinary team evaluated the new projects and the issues with ongoing renovation projects were communicated to the direct patient care staff in the effected areas. Cross reference to A0726.