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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. Failure to ensure the contracted EVS provider complied with all applicable standards and Conditions of Participation by allowing the contractor to evaluate the services independently. Cross reference to A0083.

2. Failure to provide comprehensive oversight of the contracted EVS services when there was no documented evidence to show direct observation, supervision, and evaluation of the cleaning services performed in the hospital. Cross reference to A0084.

3. Failure to ensure there was a complete list of contracted services that included the EVS provider. This increased the risk of the hospital not being able to evaluate the services provided by the EVS provider for effectiveness and safety. Cross reference to A0085.

4. Failure to ensure the QAPI program's quality processes were designed and implemented to ensure the quality and safety of patient care provided when the data collected regarding the contracted EVS service and the infection control program was not reported to the QAPI committee to form the basis for improvements in patient safety. Cross reference to A0273.

5. Failure to ensure the QAPI program's Infection control quality indicators were focused on high volume, high risk, and problem prone areas, such as the OR, that would most likely result in improvement of safety and quality of patient care. Cross reference to A0283.

6. Failure to ensure the facility and equipment were maintained in a manner that provided an acceptable level of quality and safety for patients, staff, and visitors in multiple patient care units on both the Anaheim and Irvine campuses. Cross reference to A0724 and A0726.

7. Failure to ensure a sanitary environment and an active program to prevent the spread of infections in accordance with the hospital's P&Ps and nationally recognized infection control practices and guidelines. Cross reference to A0747.

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

Based on observation, interview, and record review, the GB failed to ensure the contracted EVS provider complied with all applicable standards and Conditions of Participation by allowing the contractor to evaluate their services independently. This resulted in the potential for an unsanitary environment for patients, staff, and visitors.

Findings:

Review of the hospital's document titled Bylaws of Kaiser Foundation Hospitals, Article A dated 12/2/16, showed "...The Committee will review and, as appropriate, provide direction in the following areas: 1. Quality Assurance. a. Overseeing quality systems, including quality goals, objectives, and performance measures; B. Identifying and addressing deficiencies in quality; c. Reviewing and as appropriate approving, standards for quality assurance, patient safety, service quality ..."

Review of the hospital's documents titled Performance Improvement Committee Minutes, Quality and Performance Oversight Committee Minutes, and Quality and Health Improvement Committee of the Boards of Directors for the year 2016 did not show documented evidence of a presentation or discussion about the quality and safety of the contracted services provided to the hospital.

During an interview with the IC staff for the Anaheim and Irvine campuses on 3/8/17 at 0845 hours, the IC staff was asked about environmental cleaning. The ICP Manager stated the EVS staff reported the Glo-Germ reports once a month. The ICP Manager stated the IC staff conducted rounding twice a year for each area. ICPs 1 and 3 stated they talked to EVS staff and informed the Unit Managers when any concerns were identified during their rounding. However, the staff stated they did not formally document the concerns identified or what were discussed with the EVS staff during their rounding.

When the IC team was asked when the Glo-Germ testing took place in the ORs, ICP 3 stated the testing was done after the ORs were terminally cleaned once per month and no Glo-Germ testing was done between OR cases. ICP 1 also stated the immediate corrections were implemented at the time of the routine rounding with the EVS Manager. However, there was no documented evidence to show the routine rounding (collection and analysis of quality indicators) and immediate corrections. The ICP Manager stated that EVS (management) "report to us on validation" (cleanliness of the OR's).

Review of the Glo-Germ monthly report dated February 2016 showed the following:

*Two of the three L&D ORs were tested twice within the month. One was not tested.
*Two of the six Surgical Centers were tested twice within the month. Four were not tested.
*All seven main ORs were tested within the month. One was tested three times, three were tested twice, and three were tested once.
*The section of the monthly report titled Employee Assigned was left blank for each test.

On 3/8/17 at 1440 hours, a meeting with the QAPI staff for the Anaheim and Irvine campuses was conducted. The QAPI staff was asked how contracted services, including environmental cleaning (EVS) were evaluated. The Director of Quality stated the contracted services were not a standing item on the QAPI minutes and EVS did not report to QAPI.

During an interview with the hospital's CEO and Nursing Service Administrators for the Irvine and Anaheim campuses on 3/8/17 at 1500 hours, the leadership team was unable show verification the data collection from the EVS contractor was accurate. The leadership team could not show documented oversight of the EVS services by the Infection Control Committee, Quality Improvement Committee, and Governing Body.

Based on observation, interview, and record review, the hospital failed to ensure the GB provided comprehensive oversight of the contracted EVS provider. There was no documented evidence to show direct observation, supervision, and evaluation of the cleaning services performed in the hospital. In addition, the hospital's competency validation tool was not used to evaluate the job performance of two EVS staff (EVS 1 and C). This failure had the potential for negative effects in maintaining a clean and sanitary environment for the patients.

Findings:

1. On 3/6/17 at 1020 hours, EVS 1 was observed cleaning L&D OR 2 on the Anaheim campus. EVS 1 failed to perform a thorough cleaning of the OR according to the hospital's P&P or per the AORN guidelines. Cross reference to A0749, example #1b.

On 3/7/17 at 1400 hours, the EVS Supervisor was interviewed. The Supervisor was informed of the observation of EVS 1 cleaning L&D OR 2. When asked how the competencies of EVS 1 including between cases OR cleaning were validated, the EVS Supervisor stated the EVS staff was required to do annual training by watching online videos. The EVS Supervisor stated the EVS staff's cleaning competencies were validated using the Competency Validation Tool: Operating Room Cleaning Procedure (between cases) form.

Review of the Competency Validation Tool: Operating Room Cleaning Procedure (between cases) form showed the method of validation was through direct observation and included the following:
*Hand washing
*Appropriate attire for the OR
*Preparation needed in order to perform OR cleaning
*Using approved germicidal disinfectant
*Appropriate dwell time for disinfectant
*Using mechanical friction
*Frequency of changing germicidal solution
*Correct PPE for the OR
*Using the same mop and cleaning cloths to clean more than one OR
*What equipment should be moved during cleaning
*Steps to perform before emptying trash

On 3/9/17, review of the employee file for EVS 1 showed a hire date of 3/30/09. Review of the latest Performance Appraisal Review showed it was conducted on 1/7/15, by The EVS Assistant Administrator for the Irvine campus, not by the EVS administration for the Anaheim campus where EVS 1 was an employee. The performance appraisal for EVS 1 did not indicate how the appraisal was conducted, either through direct observation or other methods. The performance appraisal for EVS 1 showed a check box marked "Improvement Needed" in the category of "Thoroughness." In the comments section of the performance appraisal for EVS 1, a list of strengths were identified; however, there were no comments documented to show any plan for improvement and no goals were identified to address the lack of "thoroughness."

Further review of the employee file for EVS 1 showed the last evaluation with the Competency Validation Tool: Operating Room Cleaning Procedure (between cases) was dated 6/30/10.

On 3/8/17 at 1525 hours, an interview and concurrent employee file review for EVS 1 was conducted with the RN Educator. The Educator verified the Competency Validation Tool: Operating Room Cleaning Procedure (between cases) should be done every year for EVS staff working in the ORs. The RN Educator verified the tool had not been completed for EVS 1 since 6/30/10.

On 3/8/17 at 1550 hours, an interview and concurrent employee file review was conducted with the EVS ADA for the Anaheim campus. The EVS ADA was asked why EVS 1 was not evaluated with the Competency Validation Tool: Operating Room Cleaning Procedure (between cases) for almost seven years. The EVS ADA stated he could not speak to how competency validation was done prior to the EVS contractors being brought in five years ago; however, the validation tool was "new" for the contractors as of last year. The EVS ADA further stated because EVS 1 was on a leave of absence between September 2016 and February 2017, she did not have an updated competency validation tool in her file. When asked how EVS 1 was evaluated on an ongoing basis in the last five years, the EVS ADA stated through rounds. When asked if the EVS supervisors ever scheduled direct observations of EVS staff, the EVS ADA stated no, they just did "random rounds."


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2. On 3/8/17 at 1000 hours, copies of the Anaheim Medical Center Master Terminal Surgical Suite Cleaning Record were reviewed with the Director of EVS services. The document showed for staff to initial each box the staff had completed, and all the tasks must be signed off at the time of completion.

Review of the document for the week of 1/22 to 1/28/17, showed in the section to document the cleaning of the SPD Floor Care 1st shift and OR Floor Care 3rd shift, an "X" was documented instead of the staff's initials.

The Director stated she never reviewed the documents and stated the "X" should not be there. The Director further stated she was not aware as to what "all tasks" referred in this document. The Director stated the Shift supervisor(s) would be responsible to evaluate the EVS staff work, but she did not have any documented evidence of the supervisor's evaluation because those were all done verbally. The Director stated she performed direct observation and rounds to oversee and evaluate the EVS staff's performance, but she did not keep a log or document her rounding or observations. The Director stated the EVS surveillance were reported to the IC committee; however, this did not include the direct observation and evaluation of cleaning for the hospital's EVS services.


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3. Review of the hospital-provided document titled SEIU-UHW [(Service Employees International Union-United Healthcare Workers) a union for healthcare workers] Collective Bargaining Unit dated 9/30/16, showed evaluation during the probationary period would include appropriate training and orientation tools. A written performance evaluation would be issued upon 60 calendar days, though the probationary period was for 90 days.

On 3/6/17 at 1420 hours, during an interview on the Irvine campus, EVS C failed to verbalize the correct wet time for the cleaner used to mop the OR floor according to the manufacturer's instructions. Cross reference to A0749, example #1c.

Review of EVS C's personnel file and a concurrent interview was conducted with the EVS ADA on 3/8/17 at 08225 hours. EVS C was hired on 9/19/16, as a housekeeper.

Review of the Individual Training Record form dated 1/5/17 (approximately 112 days after hire), showed EVS C received the initial training on infection prevention measures and the necessary functions for effectively turning over (cleaning and preparing the room for a new patient) a vacated patient room. The EVS ADA stated new employees were trained and shadowed for a period of two weeks, then were able to work independently after 90 days. The EVS ADA stated new employees were evaluated on their performance. However, the EVS ADA verified EVS C did not have a probationary evaluation within the 90 day window.

Review of the Employee Performance Appraisal Review form dated 1/3/17, 110 days after hire, showed EVS C's completion of her probationary period. The following areas were listed as "Meets Requirements":
* Performance standards/quality
* Accuracy
* Thoroughness
* Need for supervision
* Problem-solving ability

However, further review of the record failed to show the method used to evaluate EVS C for the above criteria. The EVS ADA stated the hospital began implementing a competency validation tool after 8/16 which would require direct observation of tasks. However, the EVS ADA confirmed EVS C's competency validation tool was not completed, even though she was newly hired since 9/16.

Based on interview and record review, the hospital failed to ensure there was a complete list of contracted services that included the EVS provider. This increased the risk of the hospital not being able to evaluate the services provided by the EVS for effectiveness and safety.

Findings:

Review of the hospital's document titled Bylaws of Kaiser Foundation Hospitals, Article A dated 12/2/16, indicated "...The Committee will review and, as appropriate, provide direction in the following areas: 1. Quality Assurance. a. Overseeing quality systems, including quality goals, objectives, and performance measures; B. Identifying and addressing deficiencies in quality; c. Reviewing and as appropriate approving, standards for quality assurance, patient safety, service quality ..."

Review of the hospital's document titled Master List of Contract Orange County (undated) showed no documented evidence the EVS provider was included on the list of contracted services.

Review of the hospital's documents titled Performance Improvement Committee Minutes, Quality and Performance Oversight Committee Minutes, and Quality and Health Improvement Committee of the Boards of Directors for the year 2016 failed to show documented evidence a presentation or discussion about the quality and safety of the contracted services provided to the hospital.

On 3/9/17 at 1010 hours, an interview and concurrent record review was conducted with the Support Services Administrator. The Administrator reviewed the Master List of Contract Orange County and stated he was unable to find documentation of the EVS provider on the list. The Administrator stated, "I don't know why it's not on the list."

Based on observation, interview, and record review, the hospital failed to ensure their QAPI program's quality processes were designed and implemented to ensure the quality and safety of patient care provided as evidenced by:

1. Failure to ensure the QAPI program's data collected regarding the contracted EVS provider and the infection control program was documented and reported to the QAPI committee to form the basis for improvements in patient safety. Cross reference to A0273.

2. Failure to ensure the QAPI program's Infection Control quality indicators were focused on high volume, high risk, and problem prone areas, such as the OR, that would most likely result in improvement of safety and quality of patient care. Cross reference to A0283.

The cumulative effect of these systemic failures resulted in the hospital's inability to provide an efficient QAPI program and quality healthcare to the patients in the hospital.

Based on observation, interview, and record review, the hospital failed to ensure their QAPI program's quality processes were designed and implemented to ensure the quality and safety of patient care provided. The data collected regarding the contracted EVS provider and infection control program was not reported to the QAPI committee to form the basis for improvements in patient safety. This practice increased the risk of poor patient health outcomes.

Findings:

Review of the hospital's document titled Quality Program Integrated Strategic Workplan Evaluation- 2015 indicated "...VII. Transforming care through indicator monitoring as required by accreditation, regulation or licensing...Hospital Infection Control Program...IC (Infection Control) Rounds, Env. Cleaning (Environmental cleaning- how clean the Environmental Services contracted service maintained the hospital), Select SSI's, (surgical site infections) Surgery Observations..."The facility document titled "Quality Program Integrated strategic workplan for 2016" indicated "...VIII. Transforming care through medical center contract oversite; (Contracted Hospitals and Hospital Services). Quality Oversight of Contracted Providers/ Facilities...Review and document recommendations ongoing..."

According to the AORN's Recommended Practices for Environmental Cleaning, the "X.a. Process monitoring must be a part of every perioperative setting as part of an overall environmental cleaning program. Process monitoring should include ...monitoring cleaning and disinfection practices ..."X.c.1. Immediate feedback of assessment findings should be provided to perioperative and environmental services personnel when possible ..."

During the survey, concerns were found with the EVS staff job performance during the cleaning procedures on both the Anaheim and Irvine campuses, especially in the peri-operative areas. Cross reference to A0749, examples #1a. 1b, 1c, 2, 3a, 3b, 3d, 10, 14a, 14c, 14d, 14g, 14h, 15a, 15b, 15c, 17a, 17b, and 18.

During an interview on 3/8/17 at 0820 hours, the Support Services Administrator was asked who was responsible for conducting the Glo-Germ tests for the ORs and L&D. The Support Services Administrator stated the EVS and Infection Control staff worked together to conduct the Glo-Germ testing in the ORs once per month.

On 3/8/17 at 0845 hours, an interview was conducted with the Infection Control staff for the Anaheim and Irvine campuses. When asked when the Glo-Germ testing took place in the ORs, ICP 3 stated the testing was done after the ORs were terminally cleaned once per month, and no Glo-Germ testing was done between OR cases. ICP 1 also stated immediate corrections were implemented at the time of the routine rounding with the EVS Manager. However, there was no documented evidence to show the routine rounding (collection and analysis of quality indicators) and immediate corrections. The ICP Manager stated the EVS management "report to us on validation" (cleanliness of the OR's).

Review of the Glo-Germ monthly report dated February 2016 showed the following:
*Two of the three L&D ORs were tested twice within the month. One was not tested.
*Two of the six SCs were tested twice within the month. Four were not tested.
*All seven main ORs were tested within the month. One was tested three times, three were tested twice, and three were tested once.
*The section of the monthly report titled Employee Assigned was left blank for each test.

On 3/8/17 at 1000 hours, an interview with the Director of EVS services was conducted. The Director stated she performed direct observation and rounds to oversee and evaluate the EVS staff's performance, but she did not keep a log or document her rounding or observations. The Director stated the EVS surveillance that was reported to the IC committee did not include direct observation and evaluation of cleaning for the hospital's EVS services.

On 3/8/17 at 1440 hours, a meeting with the QAPI staff for Anaheim and Irvine campuses was conducted. When asked how contracted services, including the EVS, were evaluated, the Director of Quality stated the contracted services were not a standing item on the QAPI agenda and the EVS did not report to the QAPI committee. The Director of Quality further stated issues related to EVS went straight to the MEC.

Based on interview and record review, the hospital failed to ensure the QAPI program's Infection Control Quality Indicators were focused on high volume, high risk, and problem prone areas, such as the ORs, that would most likely result in improvement of safety and quality of patient care. This practice increased the risk of poor patient health outcomes.

Findings:

Review of the hospital's document titled Southern California Medical Center Service Area-Orange County Quality Management Program Description - 2016 indicated "...Performance Improvement Activities...Activities reflect the needs of the membership and focus on high volume, high risk, and problem-prone areas for which quality improvement or loss prevention activities are likely to result in improvements in care and service, access, safety, and satisfaction...Prioritization of Quality Improvement (QI) Activities...High volume diagnoses and procedures. Problem prone diagnoses and procedures..."

Review of the hospital's document titled Quality Program Integrated Strategic Workplan Evaluation- 2015 indicated "...VII. Transforming care through indicator monitoring as required by accreditation, regulation or licensing...Hospital Infection Control Program...IC (Infection Control) Rounds, Env. Cleaning (Environmental cleaning- how clean the Environmental Services contracted service maintained the hospital), Select SSI's, (surgical site infections) Surgery Observations..."The facility document titled "Quality Program Integrated strategic workplan for 2016" indicated "...VIII. Transforming care through medical center contract oversite; (Contracted Hospitals and Hospital Services). Quality Oversight of Contracted Providers/ Facilities...Review and document recommendations ongoing..."

According to the AORN's Recommended Practices for Environmental Cleaning, the "X.a. Process monitoring must be a part of every perioperative setting as part of an overall environmental cleaning program. Process monitoring should include ...monitoring cleaning and disinfection practices ..."X.c.1. Immediate feedback of assessment findings should be provided to perioperative and environmental services personnel when possible ..."

Review of the hospital's documents titled Performance Improvement Committee Minutes, Quality and Performance Oversight Committee Minutes, and Quality and Health Improvement Committee of the Boards of Directors for the year 2016 showed no documented evidence to indicate the IC program quality indicators were prioritized to focus on high risk, high volume and problem prone areas.

During the survey, concerns were found with EVS staff during the cleaning procedures in the Anaheim campus's main OR and L&D OR and the Irvine campus OR. In addition, on the Irvine campus, multiple pieces of rusty equipment were found, temperature, humidity, and air exchanges were not monitored, biological indicators testing was not done per the P&P, sterilizers were not maintained weekly, IUSS cycles were not monitored and documented per standard, and the use of LMAs were not tracked. Cross reference to A0749, examples #1, 2, 3, 4, 5, 7, 8, 9, 10, 14, 15c, 17, and 18.

During an interview and record review with the EVS ADA and ICP 1 on 3/7/17 at 0835 hours on the Irvine campus, ICP 1 stated a multidisciplinary team including the IC staff and EVS staff conducted environmental rounds. Informal rounding was conducted once a week and formal rounding was conducted monthly. However, the staff stated there was no consistency in environmental rounding since they were short of staff up until a few months ago.

During an interview with the IC staff for both the Anaheim and Irvine campuses on 3/8/17 at 0845 hours, at Anaheim campus, the IC staff was asked about the IC committee and environmental rounding. The ICP Manager stated the IC staff coordinated with the EVS and engineering staff. The EVS staff reported cleaning validation and engineering staff reported air handling, temperature, and humidity.

When asked about the environmental cleaning, the ICP Manager stated the EVS staff reported the Glo-Germ reports once a month. The ICP Manager stated the IC staff conducted rounding twice a year for each area. ICPs 1 and 3 stated they talked to the EVS staff and informed the Unit Managers when concerns were identified during their rounding. However, the staff stated they did not formally document the concerns identified or discussed with the EVS staff during their rounding.

During the meeting, the IC team was made aware of the concerns found with the cleaning and other issues found in the ORs. The IC team was asked how often they did PET rounds in the ORs. ICP 3 stated the rounds should be done twice a year, but were skipped the last time they were due because of infection control staff turnover at both campuses. When asked when the last PET rounds in the L&D OR at the Anaheim campus took place, ICP 3 stated she did not know the last time someone did rounds there. ICP 1 stated the IP overseeing L&D resigned, so no one was overseeing the L&D ORs; however, those locations would be part of the PET rounds when the infection control team was fully-staffed at both campuses.

On 3/8/17 at 1430 hours, the AR&L DA provided a document for Anaheim OR rounding and stated there was no other document for the year 2016. Review of the document showed on 4/1/16, a procedure was observed on Surgical Center OR 5. Comments documented showed: "Anesthesiology-no hand hygiene before drawing medication."

During an interview and record review with the AR&L DA on 3/9/17 at 0840 hours at the Anaheim campus, the AR&L DA provided a Total Joint Replacement Surgery Observation Summary for the Irvine campus dated 3/14/16, which showed an observation was conducted for the surgery/surgical area. The DA was unable to find documentation to show any other observations for surgery/surgical areas were conducted at the Irvine or Anaheim campuses Perioperative areas since 3/16. The DA was unable to find documented evidence to show any actions or follow-up addressing concerns identified during the Irvine campus surgery observation on 3/16. Review of the Total Joint Replacement Surgery Observation Summary for the Irvine campus dated 3/14/16, showed findings during observation included a rusty cart and dusty vent.

During an interview and record review with the EVS DA and Regional Director AR&L on 3/9/17 at 0950 hours, the EVS DA was asked how the Anaheim and Irvine campus perioperative areas were evaluated for cleanliness. The EVS DA stated the morning EVS supervisor conducted inspections of perioperative areas including the ORs and SPD. When asked, the DA confirmed there was no documented evidence to show the EVS supervisor evaluated the perioperative areas for cleanliness. The DA stated the Glo-Germ testing was used as a surveillance tool for EVS services and was done for patient rooms, examination rooms, OR rooms, and waiting rooms. The DA stated the Glo-Germ testing was not done in the SPD area and no reason was given to exclude the SPD area from the Glo-Germ testing. The DA stated EVS randomly conducted rounding in a certain areas; but no rounding schedule was established. When asked, the DA stated an inspection of the SPD area was conducted at the Irvine campus last week and at the Anaheim campus two and a half weeks ago. The DA stated there were some concerns identified during the inspection; however, the DA stated the identified concerns during the inspection of the SPD were not documented.

On 3/8/17 at 1440 hours, a meeting with the QAPI staff for the Anaheim and Irvine campuses was conducted. The QAPI staff was asked how the contracted services, including EVS, were evaluated. The Quality DA stated the contracted services were not a standing item on the QAPI minutes and EVS did not report to QAPI. The Quality DA further stated issues related to EVS went straight to the MEC.

Based on interview and record review, the hospital failed to ensure the nursing staff evaluated the care of two of 31 sampled patients (Patients 1 and 5). For Patient 1, the placement of a PICC line was not verified prior to using the line to infuse the medications and draw blood work. For Patient 5, the nursing staff did not follow the P&P for removal of the patient from contact isolation precautions and did not assess the patient for the need for protective precautions. These failures had the potential for unsafe care to the patients.

Findings:

1. Review of the hospital's P&P titled Central Venous Access Device (CVAD) care and Maintenance dated 12/16 showed when a patient is admitted with a CVAD in place and the tip placement documentation is unavailable or unreliable, the placement will be verified with a chest x-ray prior to use. The P&P also showed to verify the provider's order for laboratory work prior to initiating a blood draw.

Patient 1's medical record review was initiated on 3/10/17. The medical record showed Patient 1 was admitted to the hospital with a PICC line inserted on 3/5/17.

Review of Patient 1's x-ray report dated 3/5/17, showed a chest x-ray was performed due to complaints of shortness of breath. However, the report failed to show the verification of the PICC line placement.

Review of the EMAR showed Patient 1 received medications via the PICC line on 3/5/17 at 1944 hours, 3/6/17 at 1352 hours, and 3/7/17 at 0403, 0619, and 0921 hours.

Review of the Flowsheets showed blood was drawn from the PICC line on 3/5/17 at 2222 hours, 3/6/17 at 1000 hours, and 3/7/17 at 0100 hours.

During an interview and concurrent medical record review with the Information Practice Specialist on 3/7/17 at 1400 hours, the Specialist verified Patient 1's PICC line was used by nursing staff without placement verification.


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2a. On 3/7/17, review of the hospital's P&P titled Isolation: Standard and Transmission-based Precautions revised 11/10 showed, on #7.0, the Criteria to Discontinue Isolation Precautions. On #7.4, documentation showed, "Contact Plus Precautions may be discontinued for Clostridium difficile when the patient's diarrhea has been absent for at least 48 hours and:
7.4.1 Patient must be continent of stools
7.4.2 Patient is able to stand in the shower and wash the C. difficile spores from the body using soap and water. Rinse well.
7.4.3 Patient dons a new gown.
7.4.4 Patient is transferred to a new private room that has been cleaned.
7.4.5 Previous room is terminally cleaned using bleach or hydrogen peroxide agent and curtains are changed.

On 3/6/17 at 0930 hours, the Anaheim campus DOU was toured with the ICU/DOU ADA. A sign hanging by Patient 5's room door showed the patient was on contact isolation. When asked about the reason for the contact isolation, the unit's Charge Nurse (RN 21) stated the isolation was because the patient's diarrhea was positive for C. difficile (a bacterial infection that causes diarrhea). RN 21 stated the isolation could be discontinued as Patient 5 had two negative stool tests for C. difficile. RN 21 removed the contact isolation sign and replaced it with a standard precaution sign. However, the requirements of the above P&P were not reflected in the observed practice as the patient was not moved to a clean room and the P&P did not require a negative C. difficile test to discontinue the contact isolation.

b. On 3/7/17, review of the hospital's P&P titled Protective Precautions revised on 2/16 showed protective precautions might be required to prevent the transmission of disease spread by droplet, airborne, or contact routes from staff and visitors to patients who were neutropenic or immunocompromised. Persons, including health care workers and visitors with any infectious or respiratory illness should not enter the room. Protective precautions would be initiated and a sign would be placed on the patient's room door. Fresh cut flowers would be kept out of the room, a low bacteria diet would be ordered, and only distilled bottled water would be used.

Concurrent review of the CDC's Neutropenic Precautions (abnormal WBC) dated 10/09 showed the different neutropenia levels: mild - less than 1000/ml; moderate - less than 500/ml; profound/severe - less than 100/ml. Per the CDC, neutropenic precautions should continue until the WBC level was greater than 500/ml.

On 3/6/17 at 0940 hours, medical record review for Patient 5 showed the patient had acute leukemia (rapid growth of abnormal WBCs leaving patients with no infection-fighting capacity). Review of the patient's complete blood count level dated from 3/4 to 3/6/17, showed the patient's WBC level was 0.1/ml [normal = 4.0-11/ml]; red blood cells average level of 2.6/ml [normal = 4.2-5.4/ml] and platelets, average level of only 50, down to 16/ml [normal = 130-400/ml]. There was no documentation to show protective precautions were considered or instituted for the patient, despite the critical WBC and platelet levels. In addition, the contact isolation was discontinued on 3/6/17, by RN 21.

On 3/7/17 at 0900 hours, the findings were shared with the Department Administrator of Accreditation and Licensing. The hospital's P&P on protective isolation was discussed as the hospital's P&P did not include at what WBC level the reverse isolation would be implemented. No answer was provided to the survey team during the exit conference on 3/9/17.

Based on observation, interview, and record review, the hospital failed to ensure the nursing staff developed an accurate care plan to meet the needs of one of 31 sampled patients (Patient 11). Inaccurate and non-specific care plans could lead to interventions not provided for the patient.

Findings:

Review of the hospital's P&P titled Patient Plan of Care revised 8/14 showed the plan of care is initiated within eight hours of admission and reviewed/updated throughout the hospital stay. The plan of care will be reviewed/updated every shift and when there is a change in the patient's condition. The plan of care shall be individualized and will include measurable multidisciplinary goals.... Upon creating the plan of care, the nurse will only select goals and interventions appropriate for the individual patient based on the nurse's assessment.

On 3/6/17 at 1000 hours, during the initial tour of the Anaheim campus ICU, Patient 11 was observed with an EVD apparatus to reduce the pressure inside the patient's skull. The ICU Charge nurse (RN 22) stated only specially trained nurses could care for patients with EVDs due to the complexity of the patient's neurological condition and the CSF's high susceptibility to infection.

Review of Patient 11's medical record showed a H&P examination dated 2/25/17, indicating the patient had a severe headache leading to confusion and drowsiness with no respiratory issues. However, review of the patient's infection prevention nursing care plan showed Patient 11's risk/actual infection was due to airway/ventilation management. The interventions included to maintain airway patency, promote calming measures and pulmonary hygiene. None of the multidisciplinary goals and interventions on the infection prevention nursing care plan were related to patient's current physical condition.

Further review of the care plans for Patient 11 showed a care plan for seizure precautions and the assessed risk was from acute alcohol withdrawal syndrome. The planned intervention was to maintain a clutter-free environment. However, the patient's H&P examination dated 2/25/16, failed to show any history of the patient's alcohol consumption.

The care plan for dysphagia (difficulty swallowing) was part of aspiration precautions. The planned intervention was to maintain an upright position which was contrary to the physician's order to maintain the height of Patient 11's bed at 30 degrees as required for the EVD device.

The care plan for cerebral edema (brain swelling) showed the edema was from a carotid endarterectomy (surgical correction of narrowed carotid artery). However, carotid surgery was never listed on the patient's surgical history.

Breast tumor resection was listed on Patient 11's surgical history dated 6/97. However, the patient's current care plan also included a plan to address invasive diagnostic breast procedures, skin exposure, and thermoregulation (temperature regulation).

Spinal cord injury was also included in the care plan where bowel program maintenance was one of the interventions. However, Patient 11 had no medical history of spinal cord injury per the H&P examination. In addition, the patient was assessed as a patient actively dying where urinary elimination should be promoted. Documentation in the medical record showed Patient 11 had stable vital signs and was able to communicate needs.

Review of the care plan showed the above care plans and interventions were reviewed with the patient and the family member on 3/17/17.

On 3/7/17 at 0900 hours, Patient 11's care plan was reviewed with the Clinical Specialist/Educator. The Clinical Specialist was unable to show documentation in the medical record a care plan was developed to address the prevention of infection due to the EVD. In addition, the Clinical Specialist was unable to explain how the above care plans, which did not reflect the patient's actual needs, were developed and were not detected as inaccurate by other nurses when the care plans were reviewed and updated every shift as per the hospital's P&P.

Based on observation and interview, the hospital failed to ensure an ICU RN had specialized qualifications and competence to care for one of 31 sampled patients (Patient 11). This failure could contribute to the patient receiving unsafe care.

Findings:

On 3/6/17 at 1000 hours, during the initial tour of the ICU accompanied by RN 22, an observation of Patient 11 showed the patient had an EVD apparatus to help drain the spinal fluid to reduce the pressure inside the patient's skull. The ICU Charge nurse (RN 22) stated only specially trained nurses could care for EVD patients due to the complexity of the patient's neurological condition and the spinal fluid's high susceptibility to infection. RN 24 was observed providing care to Patient 11.

During a concurrent interview, RN 24 was asked to explain the rationale for Patient 11's EVD. RN 24 had to verify the reason in the patient's electronic medical record. When RN 24 was asked to demonstrate the care of the patient's EVD, RN 22 had to remind the nurse to wear gloves to prevent spinal fluid contamination. In addition, RN 24 failed to accurately demonstrate the monitoring of the level of pressure in the patient's skull.

Based on observation, interview, and record review, the hospital failed to ensure the safe storage of medications in the Anaheim campus's Medical Surgical unit and Irvine campus's Outpatient Surgery Center. This practice increased the risk of unauthorized personnel having access to the medications.

Findings:

1. The hospital's P&P titled Drug Storage on Nursing Units reviewed 5/16 showed "...All spaces and areas used for the storage of drugs shall be lockable and shall be accessible only to responsible personnel authorized by the hospital, or the patient as provided in 70263(1) of Title 22 Regulations..."

On 3/6/17 at 1013 hours, the Anaheim campus's Medical Surgical Unit 6 E was toured with RN 4. Outside of a patient room, three doses of prednisone tablets (steroid medication) and one Lovenox (anti-clotting medication) syringe were found in an unlocked Isolation Cart (where protective clothing was stored).

During an interview with RN 4, she stated the medications were placed in the unlocked isolation cart right before she was going to give the medications to her next patient.


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2. On 3/7/17 at 1320 hours, a tour of OR B at the Irvine campus's Outpatient Surgery Center was conducted accompanied by RN J. An anesthesia cart containing medications was observed unlocked. RN J confirmed the observation. The RN stated the anesthesia cart should be locked.

Based on observation, interview, and record review, the hospital failed to ensure the facility and equipment were maintained in a manner that provided an acceptable level of quality and safety for patients, staff, and visitors in multiple patient care units on both Anaheim and Irvine campuses. These failures could create the increased risk of unsafe environment and safety for patients, staff, and visitors.

Findings:

Review of the hospital's P&P titled New Equipment: EIN tag, inventory validation and AIMS Add request requirements revised 12/14, showed EIN (equipment identification number) is a number assigned to a specific piece of equipment, equipment grouping, or environmental unit for purposes of identification and maintenance scheduling in the CMMS (computerized maintenance management system). The P&P also showed the following:

* New unassigned EIN tags will be provided by the Area Manager or designee only as needed for immediate device assignment. These tags will be tracked for timely utilization and required documentation into the CMMS database through an EIN tag log.

* An EIN log review will be performed on a monthly basis by the Lead-Senior Biomed, Area Manager, or designee to validate all release tags have been assigned and entered in the CMMS database. Any tags remaining un-entered into the CMMS database over 30 days will be escalated- reported to the Area Manager.

The hospital's P&P titled Rent, Demo, and Loaner Medical Equipment Management revised 12/14 showed to ensure the safe and reliability of rented, loaned, or demonstrated medical equipment at the hospital, all medical equipment shall be inspected by the appropriate service group for safety and operational integrity before patient use.

1. On 3/6/17 at 1012 hours, observation of the pre and post care areas of the Anaheim campus's Outpatient Surgical Center was initiated with RN 9 and RN 10. The following was identified:

a. Observation of the medical equipment storage room showed the following equipment did not have an EIN identifier to show the hospital's ownership or to show the equipment was safe for patient use:
- A patient examination light
- A powered operation weight scale
- Two tower fans

During a concurrent interview with RN 10, she stated the equipment was currently used for patients.

b. Observation of an ice machine showed the front cover was removed and placed on the floor near the water draining grids. An accumulation of green and black colored deposits were observed on the grids.

During a concurrent interview with RN 10, the RN stated the ice machine was under repair for problems with an ice jam about a week ago. When asked, RN 10 stated she was not aware if the repair was completed.

On 3/9/17 at 0928 hours, review of the Detailed Equipment History Report for the above ice machine, provided by the Risk Management DA, failed to show documented evidence of any order for repair for the above ice machine.

c. On 3/6/17 at 1419 hours, an observation of the equipment storage room of the outpatient Surgical Center was conducted with RN 9, the Surgicenter ADA, and Ortho Tech. No stickers to show the ownership or preventive maintenance were found for the following equipment:

- A shoulder surgical positioning device
- Two shavers used in orthopedic surgery
- Two Ultrasound machines
- An IV pump used in arthroscopy procedures

During a concurrent interview, the Ortho Tech stated some of the equipment was currently in use and some was backup equipment.

On 3/7/17 at 1000 hours, during an interview, the Support Services Administrator stated all medical equipment should be approved for use in the hospital setting for patient care and be checked by the biomed or engineering staff with an identified sticker before the equipment was sent out to the units for patient use.

2. During a tour of the Anaheim campus with Quality Coordinator 1 on 3/6/17 at 0930 hours, five patient lifts were observed stored in the hallway in the Medical Surgical units. The five patient lifts had no EIN or PM sticker.

During a tour of the Anaheim campus's Telemetry unit with Quality Coordinator 1 and the Information Practice Specialist on 3/6/17 at 1325 hours, two lifts had an EIN number but no PM stickers.

On 3/7/17, the Risk Management DA was asked to provide maintenance records for the above seven lifts. On 3/7/17 at 1255 hours, the Risk Management DA stated five of the lifts on the Medical Surgical units with no stickers had no hospital identification number. At 1625 hours, the DA stated no documented PM history was found for the two lifts with EIN numbers found on the Telemetry unit.

3. On 3/7/17 at 1046 hours, the Anaheim campus's SPD area was toured with RN 9, the Surgical Services Administrator, Quality Coordinator 1, Perioperative DA, and SPD supervisor. The following was identified:

a. A sterile dryer utilized for drying surgical instruments was observed in the processing area. According to the SPD supervisor, the dryer was used for years. The Supervisor stated the SPD staff cleaned the outside door of the dryer every day; however, there was no documented evidence to show any daily cleaning for this dryer.

On 3/9/17, review of the manufacturer's Instruction Manual for the sterile dryer showed the weekly cleaning procedure was to use a soft cloth dampened with mild detergent to wipe the exterior of the dryer and for maintenance, a periodic change of the pre-filter every two to three months, semi-annual lubrication of the blowers, and every three years replacing the HEPA filter was recommended.

Review of the Detailed Equipment History Report for the sterile dryer failed to show documented evidence the HEPA filter was changed since 9/26/13.

b. An ultrasonic cleaner utilized for cleaning dirty instruments was observed in the decontamination room. A large area of metal discoloration was observed at the bottom of the water compartment. The SPD supervisor stated he was not aware of the discoloration of the machine.

c. Review of the manufacturer's operation manual for the sterilizers in the SPD showed the users should perform the following maintenance:
- Daily maintenance by cleaning the sterilizer surface if dirty, checking the water level of the steam generator, and performing the leak and steam penetration tests.
- Weekly chamber cleaning by cleaning the chamber, chamber drain screen, and sterilizer surface.
- Quarterly/650 hours use chamber cleaning
- Yearly/2600 hours use chamber cleaning

During a tour of the Anaheim campus's SPD area on 3/7/17 at 1046 hours, the SPD supervisor stated there were seven autoclaves in the SPD with two different models, 6-0-6VS1 and 9-6-15 HS 1. The Supervisor stated the SPD staff cleaned the outside of the autoclaves on a daily basis but did not document the daily cleaning. The Supervisor stated the autoclaves were used 24 hours continuously so they were very hot; therefore, the SPD staff did not perform any cleaning or maintenance for the chambers of the autoclaves. The cleaning and maintenance was done once per year by a contracted company.

When asked, the staff could not show documented evidence the SPD staff cleaned the chambers of the autoclaves daily, weekly, or quarterly as per the manufacturer's operation manual.


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4. On 3/6/17 at 0939 hours, during the tour of the Anaheim campus Pain Procedure Room with RN 10, a crack on the floor that was approximately three inches long was observed.

5. On 3/6 and 3/7/17, observations of the Irvine campus SPD, OR, and outpatient surgical center showed items with rust, dust, or substance build up in the ORs, sterilizer room, and OR hallway. In addition, a crack was observed on the glass of a scope processor in the GI procedure area. Cross Reference to A749, example #3.

6. On 3/6/17, observation of the Anaheim campus SPD showed items were covered by dust and accumulated substances as follows:

*Heavy chemical deposit on the instrument cleaning sink and counter in the decontamination room of the SPD was observed. The SPD supervisor was not able to state how long the deposits had been there.

*Heavy accumulation of dust and trash were observed at the bottom of the door at the entrance and exit of the case cart washer. According to the SPD supervisor, EVS staff were responsible to clean the washer.

*The water draining grid was dusty and the drain pipe was rusty with an accumulation of a green colored deposit.

*Heavy accumulation of dust was observed on the surfaces under the washer instrument cart rolling racks. The SPD Supervisor stated the SPD staff was responsible for cleaning.

*An area approximately three inches long was detached from the base of the wall creating a gap from the wall. The gap was filled in with accumulated dust.

7. Reusable LMAs stored in the Irvine campus Main OR and Surgical Center were not tracked for the number of uses. Cross reference to A0749, example #7.


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8. During a tour of the Irvine Campus Labor and Delivery ORs on 3/7/17 at 0900 hours, accompanied by the Perinatal Services DA, the following observations were made in OR #1.

*An armboard was torn and taped with surgical tape.
*A sponge count IV pole contained areas of brown discoloration on the legs.
*The base of the wall was warped and pulled away from the wall.

The above findings were verified with the DA.

9. On 3/6/17 at 1120 hours, the Irvine campus Medical Surgical unit 4B was toured with the Chief Engineer. A wall puncture was noted on the wall adjacent to the water filter. There was a white powdery residue from the inner portion of the wall puncture collected into a small mound of powder along the cove base directly beneath it. The Chief Engineer stated the wall puncture should be addressed immediately.


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10. On 3/7/17 at 0957 hours, a tour of the Irvine campus Medical Surgical and Telemetry units Nourishment Rooms 3A, 4A, and 3B was conducted with the Medical Surgical Telemetry Administrator.

a. At 1000 hours, in the 3A Nourishment Room, the inner basin of the ice machine floor drain strainer showed a white colored growth on top. The inner base of the drain also had green sludge extending from the base bottom to the upper lip of the drain perimeter. Two straws, a spoon, and a decomposed brown colored object were observed in the drain bowl. The floor space between the ice machine and the storage cabinet had a brown colored residue. The EVS ADA verified the findings on 3/7/17 at 1005 hours. The EVS ADA stated the EVS staff was responsible for cleaning the floor drains.

b. At 1027 hours, in the 4A Nourishment Room, the ice machine floor drain showed a brown sludge inside the basin, as well as along the upper perimeter of the drain.

c. At 1040 hours, in the 4B Nourishment Room, the ice machine floor drain showed a brown sludge and a green substance inside the drain, as well as a plastic wrapper.

The above findings were verified with the MST Administrator.

11. On 3/6/17 at 1400 hours, inspection of the ice machine in the ED on the Anaheim campus showed whitish colored calcification on the drain pipe and heavy whitish colored debris on the floor drain.

During the concurrent interview, the ED Clinical Director acknowledged the finding and stated the confusion as to whom to call between the housekeeping and facility services to clean the equipment.


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12. On 3/6/17 at 1330 hours, a tour of the Anaheim campus's ED was conducted with the ED Clinical Director. Outside the ED, between the loading/unloading patient area and ambulance entrance, were two decontamination shower pits. A large amount of stagnant water was present in the two shower pits. The pits were covered by steel grates and contained standing water. When asked the last time the decontamination shower was used, the ED Clinical Director stated the shower had not been used for an unknown length of time. When asked how long the large amount of stagnant water was present in the two shower pits, he stated he was not sure. The Director later acknowledged the drain pipe was not functional.

13. On 3/6/17 at 0900 hours, during the initial tour of the Anaheim campus's DOU accompanied by the ADA of ICU/DOU, a rusty, rolling phlebotomy cart was noted parked by the nurse station. Corners of the cart showed the paint was peeling, making it difficult to disinfect. The ADA of ICU/DOU acknowledged the finding and stated the cart was from an outside contracted service waiting for pick up.

14a. On 3/6/17 at 0805 hours, observation of the Anaheim campus's main lobby men bathroom showed a urine odor was evident and the odor was stronger when the men urinal was approached. This bathroom is accessible to the patients and visitors.

b. On 3/6/17 at 1005 hours, observation of the Anaheim campus's men bathroom on the fifth floor showed the entire floor area where the toilet bowl was located was filled with paper litter. This bathroom is accessible to patients and visitors.

c. On 3/6/17 at 1305 hours, observation of the Anaheim campus's men bathroom on the first floor beside the laboratory and across from the ED showed graffiti was evident behind the bathroom doors.

Based on observation, interview, and record review, the hospital failed to ensure the temperature, humidity, and air exchanges were monitored in the Irvine Campus Perioperative areas as per the hospital's P&P and AORN standards. This created an increased risk of infections.

Findings:

Review of the hospital's P&P titled Temperature and Humidity of the Sterile Processing Department dated 2/17 showed the temperature and humidity would be monitored daily and maintained by engineering via room temperature/humidity monitoring device. High humidity would increase the risk of microbial growth in areas where sterile supplies are stored. Low humidity would increase the potential of dust. The temperature should be maintained between 68 and 73 degrees F within the general works areas in sterile processing. The relative humidity should be maintained between 30 and 60 % within the sterilizing areas and sterile storage area. The decontamination area temperature should be maintained between 60 to 65 degrees F.

Review of the hospital's P&P titled Thermal Regulation (Temperature and Humidity) for the OR Department dated 9/14 showed the temperature should be maintained between 68 to 75 degrees F within the OR suites. The relative humidity should be maintained between 30 to 60 % within the ORs.

A tour of the Irvine campus's SPD was conducted with the SPD ADA and OR ADA on 3/6/17 at 1030 hours. The SPD ADA stated the SPD's temperature and humidity levels were monitored by the engineering staff.

Observations of the Irvine campus's OR area were conducted the SPD ADA, OR ADA, and RN O on 3/6/17 at 1320 and 1420 hours. In a sterilizer room, there were two sterilizers with back and front doors. The back door of the sterilizers opened into the OR sterile core (the area to store sterile supplies).

The SPD ADA stated the two sterilizers were used to run IUSS loads.

RN O stated after an IUSS cycle was completed, the OR staff removed the sterilized items from the back doors of the sterilizers and brought them into the OR.

When asked, the OR ADA stated the engineering staff monitored the temperature and humidity levels for the OR areas. Reports of the temperature/humidity levels for the SPD and OR areas were requested.

a. Review of the Temperature and Humidity Report dated 2/20 to 3/6/17, failed to show the monitoring of the SPD temperature, OR sterile core temperature and humidity, and sterilizer room temperature and humidity.

During an interview and concurrent record review with the Chief Engineer on 3/7/17 at 0835 hours, he confirmed the above findings.

b. According to the AORN's Guidelines for Perioperative Practice, 2017 edition, Guideline for Sterilization, the sterile packages should be stored under environmentally controlled conditions. Room temperature, humidity, and ventilation should be controlled in accordance with the local, state, and federal policies and regulations. Recommendations included a minimum of four air exchanges per hour for clean and sterile storage area, and a minimum of 10 air exchanges per hour for sterilizer loading/unloading area and sterilizer equipment access.

Review of the air exchange report for the Irvine campus dated 6/6/16, failed to show the sterile storage area, OR sterile core, or the sterile room were monitored for air exchanges.

During an interview and concurrent record review with the Support Services Administrator on 3/9/17 at 0830 hours, he confirmed the above findings.

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

1. The hospital failed to ensure the hospital's Infection Prevention Practitioners developed and implemented the IC policies and prioritized and focused on high risk, high volume, and problem prone areas to identify opportunities for improvement. Cross reference to A0748.

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

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

Based on observation, interview, and record review, the hospital failed to ensure the hospital's IC committee developed and implemented their IC P&Ps throughout the hospital. In addition, the IC staff failed to consistently conduct and document active surveillance of the high risk, high volume, and problem prone areas of the hospital, such as the peri-operative areas in order to identify the risks for infections. These failures created an increased risks of the spread of infections throughout the hospital.

Findings:

Review of the hospital's 2016 Infection Prevention and Control Annual Plan and Goal showed the following:

* The scope of service for the Medical Center Infection Control Program included epidemiological surveillance and environmental rounds.

* Data, summary reports, and monitoring activities are reported through the multidisciplinary IC committee at least quarterly and up through the Executive committee. Information is also presented through the Performance Improvement Committee.

* Infection control activities included the participation in the Patient Environmental Tracer (PET) Surveys conducted weekly to include twice a year hospital units as staffing permits; and partner with environmental services to ensure appropriate education for cleaning/disinfection of the environment and staff practice for the staff.

* Surveillance areas chosen are based on high risk, high volume procedures prone to healthcare associated infections, areas needing further study as identified through routine surveillance or other means such as request from departments, significant events, and environment rounds. Environmental rounds are performed in the clinical areas by the ICP; feedback on opportunities for improvement to area managers; cleaning validation studies are performed with findings reported through the IC Committee.

* Infection Control Goals for 2016 included the monitoring of regulatory compliance in surveyable departments of the service area and reporting the findings to the EOC committee and notifying the managers of recommendations for corrective actions; review performance gaps in infection prevention practice in perioperative services identified during surgery observation by the IC team. Each IP were to complete three surgery observations by December 2016.

Review of the hospital's document titled Southern California Medical Center Service Area-Orange County Quality Management Program Description - 2016 showed "...Performance Improvement Activities...Activities reflect the needs of the membership and focus on high volume, high risk, and problem-prone areas for which quality improvement or loss prevention activities are likely to result in improvements in care and service, access, safety, and satisfaction...Prioritization of Quality Improvement (QI) Activities...High volume diagnoses and procedures. Problem prone diagnoses and procedures..."

Review of the hospital's document titled Quality Program Integrated Strategic Workplan Evaluation- 2015 showed "...VII. Transforming care through indicator monitoring as required by accreditation, regulation or licensing...Hospital Infection Control Program...IC (Infection Control) Rounds, Env. Cleaning (Environmental cleaning- how clean the Environmental Services contracted service maintained the hospital), Select SSI's (surgical site infections), Surgery Observations..."

Review of the hospital's document titled Quality Program Integrated strategic workplan for 2016 showed "...VIII. Transforming care through medical center contract oversite; (Contracted Hospitals and Hospital Services). Quality Oversight of Contracted Providers/ Facilities...Review and document recommendations ongoing..."

1. According to the Association of periOperative Registered Nurses (AORN), under the "Recommended Practices for Environmental Cleaning", the "X.a. Process monitoring must be a part of every perioperative setting as part of an overall environmental cleaning program. Process monitoring should include ...monitoring cleaning and disinfection practices ... X.c.1. Immediate feedback of assessment findings should be provided to perioperative and environmental services personnel when possible ..."

Review of the hospital's documents titled Performance Improvement Committee Minutes, Quality and Performance Oversight Committee Minutes, and Quality and Health Improvement Committee of the Boards of Directors for the year 2016 failed to show documented evidence the infection control program quality indicators were prioritized to focus on the high risk, high volume, and problem prone areas.

During the survey from 3/6 through 3/9/17, concerns were found with the EVS staff during the cleaning procedures in the Anaheim campus's Main OR and L&D OR, and the Irvine campus's OR. In addition, there were multiple pieces of rusty equipment; the temperature, humidity, and air exchanges were not monitored; the testings of the biological indicators were not done per the hospital's P&P; the sterilizers were not maintained weekly; the IUSS cycles were not monitored and documented per the standard of practice; and the use of LMAs were not tracked. Cross references to A0749, examples #1, 2, 3, 4, 5, 7, 8, 9, 10, 14, 15c, 17, and 18.

During an interview and concurrent record review with ICP 1 and the EVS ADA on 3/7/17 at 0835 hours, at the Irvine campus, ICP 1 stated a multidisciplinary team including the IC staff and EVS staff conducted the environmental rounds. ICP 1 stated the informal roundings were conducted once a week and formal roundings were conducted monthly. However, the staff stated there was no consistency in the environmental rounding since they had been short of staff.

The PET (Patient Environmental Tracer) survey schedule for 2017 was provided for review. The PET survey was conducted by a multidisciplinary team including the ICP, EVS, and hospital staff. The schedule showed the following:

- All departments at both campuses, nursing as well as ancillary, were scheduled for inspection twice a year.
- The Anaheim and Irvine campuses' ORs, pre and post op, surgical center, and SPD were scheduled for March and September.
- The Anaheim campus's L&D ORs in April and October.
- The Irvine campus's L&D ORs in February and October.
- The peri-operative areas were scheduled for inspection with the same frequency as ancillary services such as the Admitting Department.

Review of the Infection Control Committee Minutes dated 11/8/16, showed (on pages 6 and 7) the topic of discussion for EVS Environmental Cleaning and Validation was "Deferred." The topics for Old Business and Standing Reports did not show documented evidence the PET rounding, ICP rounding the perioperative areas, and hand hygiene surveillance.

On 3/8/17 at 0845 hours, an interview with the IC staff for the Anaheim and Irvine campuses was conducted. When asked about the IC committee and environmental rounding, ICP 3 stated the ICPs performed the rounds at the different departments for both hospitals and documented the roundings. The ICP Manager stated the IC staff coordinated with the EVS and Engineering staff. The EVS staff reported the cleaning validation and Engineering staff reported the air handling, temperature, and humidity.

When asked about environmental cleaning, the ICP Manager stated the EVS staff reported the Glo-Germ reports once a month. The ICP Manager stated IC staff conducted rounding twice a year for each area. ICP 1 and ICP 3 stated they talked to the EVS staff and informed the Unit Managers when concerns were identified during their rounding. However, when asked about documentation, the staff stated they did not document the concerns identified or discussed with EVS staff during their rounding.

During the meeting, the team was made aware of the findings of the cleaning and other issues found in the ORs. When asked how often they did the PET rounds in the ORs, ICP 3 stated they should be done twice a year, but were skipped the last time they were due because of the IC staff turnover at both campuses. When asked when the last PET rounds in the L&D OR at the Anaheim campus took place, ICP 3 stated she did not know the last time when someone did the rounds there. ICP 1 stated the IP overseeing the L&D had resigned, so no one was overseeing the L&D ORs. ICP 1 stated these locations would be part of the PET rounds when the infection control team was fully-staffed at both campuses.

On 3/8/17 at 1430 hours, the AR&L DA provided a document for the rounding at the Anaheim OR. The DA stated there were no other documents for the year 2016. Review of the document showed on 4/1/16, a procedure was observed on the Surgicenter OR 5, and the comments was "Anesthesiology-no hand hygiene before drawing medication."

During an interview and concurrent record review with the AR&L DA on 3/9/17 at 0840 hours at the Anaheim campus, the AR&L DA provided a Total Joint Replacement Surgery Observation Summary report for the Irvine campus dated 3/14/16. The report showed an observation for the surgery/surgical area was conducted. However, the DA was unable to find documentation to show any other observations for the surgery/surgical areas were conducted at the Irvine or Anaheim campuses since 3/16. The DA was unable to find documented evidence to show any action or follow-up addressing concerns identified during the Irvine campus surgery observation on 3/16.

Further review of the Total Joint Replacement Surgery Observation Summary report for the Irvine campus dated 3/14/16, showed the findings during the observation included a rusty cart and dusty vent.

During an interview and concurrent record review with the EVS DA and Regional Director AR&L on 3/9/17 at 0950 hours, the EVS DA was asked how the peri-operative areas in the Anaheim and Irvine campuses were evaluated for cleanliness. The EVS DA stated the morning EVS supervisor conducted inspections of the perioperative areas including the ORs and SPD. When asked for documentation, the DA confirmed there was no documented evidence showing the EVS supervisor evaluated the perioperative area for cleanliness. The DA stated the Glo-Germ testing was used as a surveillance tool for the EVS services. The Glogerm testings were done for patient rooms, examination rooms, ORs, and waiting rooms, but not done at the SPD area. The DA stated there was no reason to exclude the SPD area from the Glo-Germ testing. The DA stated the EVS randomly conducted rounding in certain areas and no rounding schedule was established. The DA stated an inspection of the SPD area was conducted at the Irvine campus last week and at the Anaheim campus two and a half weeks ago. The DA stated there were some concerns identified during the inspection; however, the identified concerns during inspection of the SPD were not documented.

2. During the survey, concerns were found with the EVS staff using a floor cleaner which did not contain a disinfectant when cleaning isolation rooms on the Irvine campus as per the hospital's P&P and CDC guidelines. Cross reference to A0749, example #10.

On 3/7/17 at 0825 hours, an interview was conducted with ICP 1 and the EVS Assistant Administrator at the Irvine campus. The Assistant Administrator verified all floors (except the ORs) were cleaned with a detergent cleaner that did not contain a disinfectant. When asked if the ICP was aware the floors in the isolation rooms were not being disinfected, ICP 1 stated she was not aware.

On 3/8/17 at 0845 hours, the IC staff for the Anaheim and Irvine campuses were interviewed. When asked how the Neutral floor cleaner (which is not a disinfectant and used to clean all patient room floors on the Irvine campus) got approval for use, ICP 1 stated the cleaner was approved at the Regional level. When asked if the IC team had concerns with the use of this product in the isolation rooms, the IC staff indicated they did but their concerns were not elevated, and they accepted the Regional decision.

3. During the survey, concerns were found with the cleanliness of 13 medication rooms in the nursing units on both the Anaheim and Irvine campuses when trash and debris were found on the floor, and the medication preparation areas in the medication rooms were not free from water spray from the medication sinks, which were in close proximity without a splashguard. Cross reference to A0749, example #14.

On 3/8/17 at 0845 hours, the IC staff for the Anaheim and Irvine campuses were interviewed and made aware of the survey team's findings of unsanitary conditions in the medication rooms and central supply carts of both hospital campuses. When asked if the ICPs did rounds in the medication and supply rooms, ICP 3 stated yes; however, they had no access to the medication rooms so they did not check them daily. ICP 3 stated when they identified issues, they called the EVS staff right away and let the Unit Manager know. When asked if they did any follow-up after the EVS staff cleaned the medication rooms, ICP 3 stated yes, they went back to check for cleanliness. When asked to provide documentation of their rounds, findings, and any follow up, ICP 3 stated e-mails were sent if there were constant findings, but recently their archived e-mails had been lost. When asked if they documented their findings or follow-up anywhere else, ICP 3 stated no.

Based on observation, interview, and record review, the hospital failed to ensure the IC officers developed an effective system to implement and evaluate measures for identification, investigation, reporting, and preventing infections within the hospital as evidenced by:

1. The EVS staff in the Anaheim campus's main OR and L&D OR, and the Irvine campus's main OR failed to follow the hospital's P&P, manufacturer's instructions for the use of the disinfectant, and AORN guidelines during the cleaning procedures.

2. The terminal cleaning of the Irvine campus's peri-operative area was not completed as per the hospital's P&P and AORN guidelines.

3. The peri-operative areas in the Irvine campus were not maintained in a clean and sanitary manner. In addition, multiple pieces of equipment in the Irvine campus ORs and SPD were rusty.

4. Biological indicator testing was not done daily as per the hospital's P&P for a Sterrad NX sterilizer in the Irvine campus SPD.

5. The sterilizers in the Irvine campus SPD were not maintained weekly as per the manufacturer's recommendations.

6. The LMAs used for patients in the Irvine campus's main OR and Surgical Center were not tracked for the number of uses.

7. In the Irvine campus's main OR, the IUSS cycle was not monitored properly for sterilizers. There was no documented evidence showing the reason for the IUSS cycle, patient identification label, and the condition if the sterilization was met as per the hospital's P&P and AORN guidelines.

8. The temperature, humidity, and air exchanges were not monitored for the Irvine campus's peri-operative areas as per the hospital's P&P and AORN guidelines.

9. The hospital's P&P and CDC guidelines for disinfecting floors on the Irvine campus's isolation rooms were not followed.

10. The safe injection practices were not followed by two staff on the Anaheim campus's main OR and Pain Clinic.

11. Seven staff did not perform hand hygiene during observations on the Anaheim and Irvine campuses.

12. Staff were not able to state the correct contact time for the glucometer cleaning.

13. Thirteen medication rooms in the nursing units on both the Anaheim and Irvine campuses were not maintained in a sanitary condition. Trash and debris were observed on the floor and preparation areas in the medication rooms were not free from water spray from the medication sinks, which were in close proximity without a splashguard.

14. Six ice machines in the patient care units on both the Anaheim and Irvine campuses were not maintained in a sanitary manner. White colored deposits were noted in the ice chutes, drain pans, and grills. In addition, the ice machine drain pans and grills were not being cleaned according to the manufacturer's recommendations. These failures posed the risk of the transmission of infectious diseases.

15. In one nursing unit on the Anaheim campus, used IV pumps were not sent to the central processing department for cleaning and instead were found in a clean utility room.

16. Failure to ensure sanitary conditions in the ED. Floors were not cleaned between patients and bathrooms were not kept in a sanitary and safe condition.

17. IV tubings were not properly dated and labeled for two of 31 sampled patients (Patients 2 and 22).

18. The necessity of location of a PICC line was not evaluated for one of 31 sampled patients (Patient 1).

19. Failure of the staff to properly wear PPE.

20. Ventilators were not cleaned as instructed by the manufacturer.

21. The P&P for removal of patients from contact isolation for C difficile was not followed for one of 31 sampled patients (Patient 5).

22. A large amount of stagnant water was present in the two decontamination shower pits in the Anaheim campus's ED.

23. The area used to prepare breast milk in the nourishment room of the Anaheim campus's NICU was not designated or sanitized as specified in the hospital's P&P or per ADA Guidelines.

24. Warmed fluids in the Anaheim campus's NICU were not maintained in a safe and sanitary manner.

25. Patient Nourishment rooms were not maintained in a sanitary manner on three units on the Anaheim and Irvine campuses.

26. Bags of ice for patients and visitors use, were kept in an unsanitary manner in three Anaheim campus's nourishment room freezers.

These failures increased the risk of the spread of infections to the patients, staff, and visitors in the hospital.

Findings:

1. Review of the hospital's P&P titled Surgical Suite Between Case Cleaning (undated) showed the purpose of the policy is to detail steps for effective cleaning of the surgical suite between daily cases, and to ensure a sterile environment is maintained for the next patient. Steps to clean the cesarean section rooms between cases should be followed including:

*Wash hands thoroughly and put on PPE.
*Remove all debris from floor and surfaces.
*Using a green microfiber cloth saturated with disinfectant, wash OR lights and table, then wipe the key touch points and surfaces (kick buckets, counters, instrument carts, and hampers).
*Mop floor using microfiber mop and disinfectant.
*Mop an area approximately 3-4 feet around the OR table and a path out to the door.
*Sanitize inside the door frame, door handle, and telephones.
*Remove PPE and wash hands thoroughly.

Review of the AORN Guidelines for Perioperative Practice, 2017 Edition, Guideline for Environmental Cleaning, Recommendation II showed the patient should be provided with a clean and safe environment. Environmental cleaning and disinfection involves perioperative personnel and environmental services personnel.

II.i. Cleaning equipment should be disassembled according to the manufacturer's instructions for use, cleaned, disinfected with an EPA-registered disinfectant, and dried before storage and reuse. Cleaning the equipment prevents the growth of microorganisms during storage and prevents subsequent contamination of the perioperative area.

a. On 3/7/17 at 1410 hours, the Anaheim campus main OR was toured with RN 9, Surgical Services Administrator, Quality Coordinator 1, Perioperative DA, and OR Charge Nurse.

OR 8 was observed for cleaning between cases. The EVS staff mopped the floor with a wet mop, starting from the entrance toward the instrument table and back to the computer desk near to the entrance back to the OR table. The floor was visibly wet from a distance; however, the OR staff were observed walking and stepping on the wet floor while the mopping was on going.

b. On 3/6/17 between 1020 and 1050 hours, EVS 1 was observed cleaning the Anaheim campus's L&D OR 2. EVS 1 began cleaning by preparing green microfiber cloths saturated with Oxycide disinfectant cleaner in two separate (clean and dirty) cleaning buckets. EVS 1 stated the Oxycide was used for all surfaces, including floors in the ORs, and the surfaces must remain wet for three minutes. With gloved hands, EVS 1 used a wet cloth to wipe the surface of the giraffe (open newborn warmer) cushion, then disassembled and cleaned the remaining components of the giraffe base. EVS 1 then immediately reassembled the giraffe while the surfaces were still wet. EVS 1 then removed a pair of scissors and an electronic thermometer from a mayo stand (a removable instrument tray set on a movable stand) near the giraffe, wiped the surface of the mayo stand, and then replaced the used scissors and thermometer on top of the just cleaned mayo stand.

EVS 1 saturated a new cloth in the clean bucket of Oxycide and used it to wipe the top surface of the OR instrument table, and then wiped the bottom shelf of the table. EVS 1 then wiped the basin stands, trash stands, linen stands, and the laparotomy poles (used to hang a rack with pockets to place soiled surgical sponges for counting) with the same cloth. None of the surfaces were observed wiped completely, from top to bottom or from side to side.

EVS 1 took a cloth from the clean bucket of Oxycide and used it to wipe the outer edges of two foot stools, without wiping the centers and legs of each foot stool.

EVS 1 used a new cloth to wipe the OR table cushion sections starting with the arms, then the head, the center, and finally the foot of the table. EVS 1 then turned each cushion over and wiped the underside of each section of the cushion. None of the cushions were observed wiped completely, from top to bottom or from side to side.

EVS 1 then used a mop with a pad wet with Oxycide to mop the OR floor. Trash and debris were observed on the floor that were pushed around by EVS 1 with the mop. Several areas of the floor, including under the biohazard waste bin, were not mopped.

EVS 1 then took a wet cloth and re-wiped the top and bottom of the OR table cushions. EVS 1 then placed an arm board with a wet cushion on the unclean base of the OR table. The same cloth was then used to wipe the tops of the OR lights above the OR table. The side of one OR light was not wiped.

EVS 1 was then observed to remove a Stryker Glide sling (used to move patients from the OR table to the gurney) from the inside of the housekeeping cart and placed it on the clean OR table. When asked why the sling was stored in the housekeeping cart, EVS 1 stated she did not want to keep it on top of the cart because it would become contaminated. EVS 1 stated she cleaned the sling in the PACU and then put it inside the housekeeping cart until she finished cleaning the OR. When asked what else was stored inside the housekeeping cart, EVS 1 opened the cart and a clean linen was observed stored on the top shelf and cleaners and brushes on the bottom shelf. When asked if the cart was considered clean, EVS 1 stated the top shelf was clean. When asked what the cleaners and brushes were used for, EVS 1 stated she used them to clean the L&D patient rooms. When asked how the inside of the cart could be clean with used cleaning brushes also stored inside, EVS 1 verified it was not clean.

EVS 1 finished the cleaning process in L&D OR 2 by re-mopping the floor, this time moving the biohazard waste bin and mopping underneath. EVS 1 was not observed to clean the nurses' station desk area, telephone, and computer. EVS 1 was not observed to change gloves between clean and dirty cloth use at any time during the cleaning of the OR.

On 3/7/17 at 1400 hours, the EVS supervisor was interviewed. The EVS supervisor stated there was one EVS supervisor on duty, two shifts a day. When asked how the EVS staff was supervised, the EVS Supervisor stated she did rounds on a daily basis to make sure staff were cleaning and transporting things properly. The cleaning observation of L&D OR 2 on 3/6/17, was discussed with the EVS Supervisor. The EVS Supervisor stated none of the observed cleaning practices were acceptable. When informed EVS 1 placed the Stryker Glide sling in her housekeeping cart, the EVS Supervisor stated EVS staff should never store clean equipment or linen in their housekeeping carts.

c. Review of the hospital's P&P titled Turnover and Terminal Cleaning dated 9/14 showed cleaning/disinfection products must be used in accordance to the manufacturer's instructions regarding the use and required contact time.

Review of the manufacturer's instructions for use of the Neutral Disinfectant Cleaner showed to let the solution remain on the surface for a minimum of 10 minutes.

On 3/6/17 at 1420 hours, the cleaning of Irvine campus OR A was observed with the OR ADA. There were three staff cleaning the OR. At 1435 hours, EVS D was observed mopping the floor while the other staff was stepping on the floor. The floor did not remain wet for 10 minutes. The OR ADA was informed of the finding.

On 3/7/17 at 0835 hours, the EVS Assistant Administrator stated the dwell time for the Neutral Disinfectant Cleaner was 10 minutes; the expectation was that the surface would remain wet for 10 minutes; and no other activities would be conducted on that area during that 10 minutes.

On 3/7/17 at 1110 hours, EVS C was asked about the solution used to mop the floor. EVS C provided a container of Neutral Disinfectant Cleaner and stated the cleaner was used to mop the OR floor. When asked, EVS C stated the wet time for this solution was five minutes.

2. Review of the hospital's P&P titled Turnover and Terminal Cleaning dated 9/14 showed terminal cleaning must be done every 24 hours, regardless of whether the OR was used (excluding Saturday and Sunday at the SurgiCenters). The references for the hospital's P&P were AORN's standards.

According to the AORN's Guidelines for Perioperative Practice, 2017 edition, Guideline for Environmental Cleaning, the terminal cleaning and disinfection of perioperative areas, including sterile processing areas, should be performed daily when the areas are being used. All floors in the perioperative and sterile processing areas should be disinfected. Terminal cleaning of operating and procedure rooms should include cleaning and disinfecting of all exposed surfaces, including wheels and casters, of all items. The recommendations for terminal cleaning apply in sterile processing areas as in areas where surgical and other invasive procedures are performed. The perioperative RN should assess the perioperative environment frequently for cleanliness and take action to implement cleaning and disinfection procedures. Environmental cleaning and disinfection is a team effort involving perioperative personnel and environmental services personnel. The responsibility for verifying a clean surgical environment before the start of an operative or invasive procedure rests with perioperative nurses.

A tour of the Irvine campus's peri-operative area, GI procedure area, and radiology/cath lab area was conducted on 3/6/17 at 1030, 1320, and 1420 hours, and on 3/7/17 at 1037 hours. The Irvine campus had eight ORs, one sterilizer room next to the ORs, one main SPD area, one GI procedure room, one scope processing room, one IR room, and one cath lab room. Multiple areas in the perioperative areas were identified as having dust.

During an interview and concurrent record review with the SPD ADA on 3/6/17 at 1030 hours, the SPD ADA stated the EVS staff were supposed to clean the SPD and SPD floor daily. When asked how she ensured the EVS staff cleaned the SPD properly, the ADA stated she did not monitor how the EVS staff cleaned the SPD and the EVS supervisor would ensure or monitor the EVS staff. The ADA stated she did not have documentation to show cleaning of the SPD by EVS staff.

During an interview and record review with the OR ADA on 3/6/17 at 1320 hours, the OR ADA stated the EVS staff performed terminal cleaning of the ORs. The ADA stated she was not sure if the EVS staff performed terminal cleaning weekly or daily. The ADA stated she was not sure if the EVS staff performed the terminal cleaning for the OR sterile core (or OR hallway) or the sterilizer room. The ADA stated these areas should be cleaned by the EVS staff. The ADA was asked to provide documentation of terminal cleaning of perioperative areas.

Review of the Environmental Services, Operating Room Terminal Cleaning Log for December 2016, and January and February 2017 showed the following:

* EVS staff did not perform terminal cleaning every 24 hours as per the hospital's P&P. For example:

- On 2/5/17, there was no documented evidence showing the terminal cleaning was done for OR 3, OR 4, OR 5, OR 6, OR 7, OR 8, GI procedure room, IR room, and cath lab room.

- On 2/11/17, there was no documented evidence showing the terminal cleaning was done for OR 5, OR 6, OR 7, and OR 8.

- On 2/11/17, there was no documented evidence showing the terminal cleaning was done for OR 4, OR 5, OR 6 and OR 7.

* The section for Supervisor Signature was left bank.

* There was no documented evidence to show the terminal cleaning was done for the SPD, OR sterile core, or the sterilizer room next to the OR.

3. According to the AORN's Guidelines for Perioperative Practice, 2017 edition, Guideline for Environmental Cleaning, all horizontal surfaces in the OR (e.g., furniture, surgical lights, booms, and equipment) should be damp dusted before the first scheduled surgical or other invasive procedure of the day. Dust is known to contain human skin and hair, fabric fibers, pollens, mold, fungi, insect parts, glove powder, and paper fibers, among other components. The purpose of damp dusting is to remove dust, not to perform surface disinfection, which is completed after each procedure and at terminal cleaning. Absorbent or non intact surfaces may become reservoirs for microorganisms and may harbor pathogens. Damaged or worn coverings should be replaced. The recommendations for terminal cleaning apply in sterile processing areas as in areas where surgical and other invasive procedures are performed.

a. During a tour of the Irvine campus's SPD area on 3/6/17 at 1030 hours, accompanied by the SPD ADA and OR ADA, the following was observed:

* Rust on the racks of two carts.

* Dust and black substance buildup was noted at the edge of the floor and around the sterilizers.

The SPD ADA confirmed the observation. The SPD ADA stated the EVS staff was supposed to clean the SPD daily.

b. During a tour of the Irvine campus's OR on 3/6/17 at 1320 and 1420 hours, accompanied by the SPD ADA and the OR ADA, the following was observed:

* In the sterilizer room, the pipe located above a floor drain was covered with a green-white substance buildup. The edge of the floor, under two sterilizers had black substance.

* OR hallway:

- There was dust and white-black substance at the corner outside of OR 5.

- There was dust and black substance buildup at the corners, underneath of the scrub sink next to OR 1 and OR 3.

* OR 4:

- The drawers of the anesthesia machine were dusty.

- One OR cart, one single ring stand, one double ring stand, and one cart had rusty casters.

- A vent grill was dusty.

- The door was chipped and had exposed wood in multiple areas.

- Surfaces of three leather stools were worn out and not intact.

* OR 1:

- A vent grill was dusty and had a black substance buildup.

- One OR cart, one Mayo stand, one single ring stand, one double ring stand, and one cart had rusty casters.

* OR 3:

- There was dust at a corner by the door.

- The edge of the wall by the door was cracked.

- One OR cart, one single ring stand, one double ring stand, and one cart had rusty casters.

The OR-ADA confirmed the findings.

c. During a tour of the Irvine campus's GI procedure area on 3/6/17 at 1500 hours, accompanied by the GI ADA, RN K, and LVN A, the glass of a scope processor was observed with a crack. RN K confirmed the finding.

d. During a tour of the Irvine campus's Surgical Center on 3/7/17 at 1320 hours, accompanied by RN J and RN L, the following was observed in OR 1:

- The drawers of the anesthesia machine were dusty.

- A vent grill was dusty.

- The baseboard had green-black spots, and was able to be cleaned by RN L.

The RNs confirmed the observation. Anesthesia Technician 1 stated the Anesthesia Technician wiped the outside of the anesthesia cart, but was unable to clean the drawers of the anesthesia cart since it contained medications and were locked.

4. Review of the hospital's P&P titled Biological and Chemical Monitoring dated 9/14 showed a biological test is run in the first load of the day whether a standard cycle or advanced cycle for Sterrad NX sterilizer.

On 3/6/17 at 1030 hours, an interview and concurrent review of the hospital's documentation was conducted with the SPD ADA at the Irvine campus. The SPD ADA stated a biological testing would be performed for the Sterrad NX Sterilizer in the main SPD when there was a scope needing sterilization. The SPD ADA stated biological testing would not be performed daily unless a scope needed to be sterilized.

Review of the SPD documentation failed to show the biological testing for the Sterrad NX Sterilizer was completed daily as per the hospital's P&P.

On 3/9/17 at 0915 hours, ICP 1 was informed of the finding.

5. Review of the manufacturer's maintenance and safety system for the sterilizers showed the following:

* Daily maintenance (before starting the sterilizing) included cleaning the chamber drain strainer and sterilizer surface, if dirty.

* Weekly maintenance included to clean the chamber, chamber drain, and sterilizer surface.

* Clean the chamber with cotton towel or sponge; use water or washing up liquid.

During a tour of the Irvine campus's SPD and OR areas on 3/6/17 at 1030, 1320, and 1420 hours, accompanied by the SPD ADA and OR ADA, the following was observed:

* In the SPD, there were two steam sterilizers. Two pieces of tape were noted on each sterilizer. Dust and black substances buildup were noted at the edge of the floor and around the sterilizers.

* In a sterilizer room in the OR area, there were two other steam sterilizers. The front doors and back doors of the two steam sterilizers had dust buildup.

On 3/6/17 at 1030 and 1320 hours, the SPD ADA confirmed the above observations. The SPD ADA stated the SPD staff wiped down the surface or the outside of the sterilizers once a week, and did not clean the sterilizer chamber because it was hot.

During an interview and concurrent record review with the Regional Director AR&L, AR&L DA and SPD Supervisor on 3/9/17 at 1400 hours, the AR&L DA and SPD Supervisor confirmed there was no documented evidence to show the SPD staff cleaned the sterilizer chambers weekly as per the manufacturer's instructions. The AR&L DA and SPD Supervisor stated they received a letter from the sterilizer's manufacturer stating there was no need to clean the sterilizer chamber.

On 3/9/17 at 1400 hours, the letter from the sterilizer's manufacturer was provided by the AR&L DA and SPD Supervisor. Review of the letter showed "the recommended maintenance for ... products is specified in ... manual, which is considered labeling for ... product," the manufacturer "had no recommendations for chamber cleaning other than what is specified in the manual."

6. On 3/6/17 at 0930 hours, an observation of the Anaheim campus's NICU clean utility room was conducted with the NICU ADA and RN 1. A fluid warming unit was observed with an external temperature of 40 degrees Celsius. Three liters of sterile water, three liters of inhalation fluid, one 250 ml of sodium chloride solution, and one 40 ml of sterile water were stored inside. None of the fluids were labeled with the date they were placed in the warmer. When asked about date labeling, the NICU ADA stated the staff did not label the fluids in the warmer; they just went by the manufacturer's expiration date. When asked how long the fluids had been in the warmer, RN 1 stated she could not tell.

7. Review of the manufacturer's recommendations for use of the LMA showed the LMA Fastrach Reusable Airway may be used a maximum of 40 times before being discarded.

* On 3/6/17 at 1420 hours, an observation, interview, and record review with Anesthesia Technician 2 and the OR ADA at the Irvine campus main OR was conducted. Five LMAs were observed stored in the intubation cart. Anesthesia Technician 2 stated these LMAs were reusable and would be brought to the SPD for sterilization and tracking.

On 3/6/17 at 1445 hours, the OR ADA stated there was no tracking record of the number of uses of the above LMAs.

* On 3/7/17 at 1320 hours, an observation, interview, and record review with Anesthesia Technician 1, RN J, and SPD Supervisor A in the surgical center at the Irvine campus was conducted. Three LMAs were observed stored in the intubation cart. Two of the three LMA packages did not contain a tracking record. Anesthesia Technician 1 stated these LMAs were reusable and would be processed by the SPD after use. The SPD Supervisor stated the reusable LMAs would be discarded after being used 40 times. However, when asked, the SPD Supervisor was unable to find documented evidence to show use of the two of three above LMAs were tracked.

8. According to the AORN's Guidelines for Perioperative Practice, 2017 edition, Guideline for Sterilization, each sterilization cycle should be monitored to verify that parameters required for sterilization have been met. The sterilizer operator should use physical monitors to verify cycle parameters for each load. Physical monitors (e.g., printouts, digital reading, graphs, and gauges) can indicate immediate sterilizer failure. Physical monitors record cycle parameters (e.g., time, temperature) for each cycle. Biological and chemical indicators should be used to monitor sterilizer efficacy and to assess whether conditions of sterilization have been achieved. A class 5 chemical integrating indicator or a class 6 indicator should be used within each sterilization container or tray used for IUSS.

Review of the hospital's P&P titled Immediate Use Steam Sterilization dated 1/17 showed the following:

* Each load is documented in the Immediate Use Daily Log. Documentation will include patient identification label, reason for IUSS cycle, cycle parameters used (e.g. temperature and duration of load), item processed, initials of operator, and the autoclave printout will be stapled to the appropriate daily log form.

* At the conclusion of the sterilization process, OR staff will remove the item(s), check the indicators to be certain the conditions for sterilization have been met, document the load contents, initial appropriately, and apply patient sticker to the Immediate Use Daily Log. The biological indicator will be run daily and documented on the daily log.

Review of the Rapid Cycle Daily Log for October, November, and December 2016 and January, February, and March 2017 failed to show the reason for the IUSS cycle, the patient identification label, and whether the conditions of sterilization were met as per the hospital's P&P and AORN standards. For example:

* On 10/8/16, the section for "pass" was left blank for one IUSS cycle.

* On 10/16/16, the section for the "reason" and "pass" were left blank for one IUSS cycle.

9. A tour of the Irvine campus's SPD area was conducted with the SPD ADA and OR ADA on 3/6/17 at 1030 hours. The SPD ADA stated the SPD's temperature and humidity levels were monitored by the engineering staff.

A tour of the Irvine campus's OR area was conducted the SPD ADA, OR ADA, and RN O on 3/6/17 at 1320 and 1420 hours. Observation of the sterilizer room showed two sterilizers. The two sterilizers had back and front doors. The back doors of the sterilizers could be opened from the OR sterile core. Observation of the OR sterile core showed sterile packages were stored there.

The SPD ADA stated the sterilizers were used to run IUSS loads.

RN O stated the OR staff removed the sterilized items from the back doors of the sterilizer after an IUSS cycle was completed and brought the sterilized items to the OR.

When asked, the OR ADA stated the Engineering staff monitored the temperature and humidity levels in the OR areas. Reports of the temperature and humidity levels for the SPD and OR areas were requested.

a. Review of the Temperature and Humidity Report dated 2/20 to 3/6/17, failed to show the SPD temperature, OR sterile core temperature and humidity, and sterilizer room temperature and humidity were monitored.

b. Review of the air exchange report for the Main hospital of the Irvine campus dated 6/6/16, failed to show the sterile storage area, OR sterile core, or the sterile room were monitored for air exchanges.

During an interview and concurrent record review with the Support Services Administrator on 3/9/17 at 0830 hours, he confirmed the finding. Cross reference to A0726.

10. Review of the hospital's P&P titled Discharge Room Cleaning Contact Isolation, undated, showed the correct steps for cleaning a discharged room that contained a patient under isolation precautions included: sanitize the floor, including the restroom, using the microfiber mop charged with disinfectant.

Review of the Guidelines for Environmental Infection Control in Health-Care Facilities, recommendations of the CDC and HICPAC updated 8/1/14, showed careful cleaning and disinfecting of housekeeping surfaces (including floors and walls) and patient care surfaces (bedrails, etc.) is recommended.

On 3/6/17 at 1130 hours, during an interview on the Irvine campus, EVS A stated all floors in the hospital were cleaned with a neutral floor cleaner. When asked if that included isolation rooms, EVS A stated yes.

Review of the product label for the floor cleaner showed the cleaner did not contain a disinfectant.

On 3/7/17 at 0825 hours, an interview was conducted with the EVS Assistant Administrator and ICP 1 at the Irvine campus. The Assistant Administrator verified all floors (except operating rooms) were cleaned with a detergent cleaner that did not contain a disinfectant. When asked if the ICP was aware the floors in the isolation rooms were not being disinfected, ICP 1 stated she was not aware.


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11. Review of APIC Position Paper titled Safe Injection, Infusion, and Medication Vial Practices in Health Care (2016) showed in part :

* The Aseptic techniques included: never use a decapping device to remove the top from a vial.

* The AORN Guidelines for Perioperative Practice, showed perioperative team members should not prepare medication products in advance and then store them in clothing or pockets since this practice increases the risk for contamination and errors.

* Aseptic Techniques included:
- Perform hand hygiene (clean hands with alcohol based hand sanitizer or with soap and water) before accessing supplies, handling vials and IV solutions, preparing or administering medications.
- Disinfect the rubber stopper of medication vials with sterile 70% alcohol before inserting a needle.
- Discourage the transporting of medication filled syringes/needles in pockets or clothing.

Review of the hospital's P&P titled Medication Administration, Medication Expiration, Medication Administration Schedules dated 8/13 showed medication vials must be disinfected with alcohol pad or 2% chlorhexidene/70% isopropyl alcohol (a disinfectant) before inserting the needleless connector, IV tubing pike of needle.

a. On 3/6/17 at 1056 hours, the Anaheim campus's Pain Clinic was toured with RN 10. Anesthesia Technician 1 was observed to remove the rubber cap of a medication vial with a decapping device. There was no disinfection of the vial observed.

On 3/8/17, Anesthesia Technician 1's personal file was reviewed with the HR Director. There was no documented evidence in the personal file to show Anesthesia Technician 1 was educated regarding the environmental cleaning and preparation of a patient for a procedure.

b. On 3/7/17 at 1410 hours, the Anaheim campus's Main ORs were toured with RN 9, Surgical Services Administrator, Quality Coordinator 1, Perioperative DA and OR Charge Nurse.

In OR 8, one anesthesia provider was observed to remove a labeled syringe from the scrub pocket and dropped the syringe in a sharps container located next to the anesthesia cart. The anesthesia provider then took out two medication vials from the anesthesia medication drawer, withdrew medications to two individual syringes, and then labeled each syringe. The anesthesia provider was not observed performing any hand hygiene before handling the vials nor disinfection of the medication vials' rubber stopper with sterile 70% alcohol before inserting a needle into the medication vials.

c. On 3/7/17 at 1020 hours, an observation of Patient A's procedure in the Irvine campus OR was conducted. Physician A was observed inserting a needle into the rubber stopper of a medication vial, withdrew the medication from the medication vial, and administered the medication to Patient A. The physician did not disinfect the rubber stopper of the medication vial before inserting the needle.

On 3/7/17 at 1035 hours, the OR Clinical Director was informed and acknowledged the finding.

12. Review of the hospital's P&P titled Hand Hygiene dated 1/16 showed all personnel and physicians must perform hand hygiene before and after gloving.

a. On 3/6/17 at 1056 hours, the Anaheim campus's Pain Clinic was toured with RN 10. The following was observed:

* MD 1 walked in to Bay 27 to evaluate a patient for procedure. There was no hand hygiene performed before examination of the patient.

* One vendor was observed wearing PPE with a mask hanging around the neck in the Pain Clinic station. The vendor was holding

Based on observation, interview, and record review, the hospital failed to ensure an Anesthesia Aide, who was providing patient care in an Outpatient Pain Clinic, worked within his/hers job description. This created a potentially unsafe patient care environment for the patients receiving care in the Outpatient Pain Clinic.

Findings:

On 3/6/17 at 1056 hours, a spinal injection outpatient procedure was observed in the Pain Procedure Room. An Anesthesia Aide was observed assisting a patient into a prone position (face down). The Aide utilized a sterile skin prep stick to disinfect the patient's injection site on the back. The Aide was observed to monitor the patient's vital signs. When MD 1 completed the procedure, the Anesthesia Aide cleaned the patient's injection site with betadine and assisted the patient to return to the Post Procedure area for recovery. The Aide returned to the Procedure Room and disinfected the room and supplies.

The Job Description for an Anesthesia Aide revised 4/11 was reviewed with the Anesthesia ADA on 3/8/17 at 1148 hours. The ADA stated the document showed the major responsibilities/essential functions for an Anesthesia Aide did not include direct patient care.