HospitalInspections.org

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Based on observation, interview, and review of quality documents, the hospital failed to develop a hospital wide quality assessment and performance improvement program to monitor, evaluate, and improve quality of patient care services through systematic data collection, analysis, implementation of process improvement, and monitoring of those plans post implementation to ensure sustained improvements in clinical care with oversight of the hospital's Governing Body.

Failure to systematically collect and analyze hospital-wide performance data limited the hospital's ability to identify problems and formulate action plans. This reduced the likelihood of sustained improvements in clinical care and patient outcomes.

Findings included:

Interview, record review, and review of the hospital's quality documents showed the following:

1. Failure to develop a coordinated process to oversee the performance of all patient care services and departments.

Cross Reference A308

2. Failure to report aggregated and analyzed data regarding negative health outcomes and incidents injurious to patients including hospital-acquired conditions.

3. Failure of the quality improvement program to collect, measure, and analyze data regarding restraint use.

Cross Reference A0273

4. Failure to develop and implement corrective action plans for identified problems and monitor for sustained improvement.

Cross Reference A0283

Due to the scope and severity of these deficiencies, the Condition of Participation at 42 CFR 482.21, Quality Assurance, and Performance Improvement was NOT MET.
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Item #1 Reporting Hospital Acquired Infection

Based on interview and review of the hospital's quality improvement program and performance data, the hospital failed to ensure that analyzed data and process improvement activities related to a hospital acquired Klebsiella outbreak affecting at least 34 patients at the hospital was reported, assessed, or monitored through the hospital's Quality Improvement Program.

Failure to report aggregated and analyzed data regarding negative health outcomes and incidents injurious to patients including hospital-acquired conditions limits the hospital's ability to ensure that process improvement is developed and implemented, and improvements are sustained to ensure improved healthcare outcomes.

Findings included:

1. Document review of the hospital's document titled, "Virginia Mason Medical Center Quality Council Charter, approved 04/25/23 showed the following:

a. The Quality Council provides oversight of the ongoing Quality Assessment and Performance Improvement (QAPI) Plan including the assessment and monitoring of quality and safety metrics, implementation of performance improvement activities, and the promotion of a culture of safety.

b. The Quality Council oversees and evaluates the Virginia Mason Medical Center (VMMC) QAPI program and plan including the identification and promotion of current and emerging quality and safety focus areas unique to Virginia Mason Medical Center.

c. The Quality Council reviewed action plans for underperforming measures and improvement efforts and ensures progress is made.

2. On 05/18/23 at 12:30 PM, Investigator #5, the Division Director of Acute Quality (Staff #511), the Quality Improvement Coordinator (Staff #512), the Interim Quality Program Manager (Staff #513), and the Division Vice-President of Quality and Safety (Staff #514) and members of the hospital's Quality Committee, reviewed the hospital's Quality Improvement Program including dashboards from 07/22 through 05/23 and committee minutes dated 01/31/23, 02/28/23, 03/28/23, and 04/25/23. Investigator #5 found no evidence that data, analyzed data, process improvement, or reevaluation related to a hospital acquired Klebsiella outbreak was reported to the Quality Improvement Council.

3. At the time of the review, Staff #511 verified the finding and stated that the hospital's Quality program had undergone significant changes and that a new program would be rolled out next month. She stated that prior to the new Quality Program there was an alternate reporting structure and as a result this had not been reported to the Quality Council for review or oversight.


Item #2 Restraint Use

Based on interview and review of the hospital's quality improvement program, the Hospital failed to ensure that data related to restraint use was reported through the hospital's quality improvement program.

Failure of the quality improvement program to collect, measure, and analyze data regarding restraint use limits the hospital's ability to develop action plans to prevent medical errors and injuries.

Findings included:

1. Document review of the hospital's document titled, "Virginia Mason Medical Center Quality Council Charter, approved 04/25/23 showed the following:

a. The Quality Council provides oversight of the ongoing Quality Assessment and Performance Improvement (QAPI) Plan including the assessment and monitoring of quality and safety metrics, implementation of performance improvement activities, and the promotion of a culture of safety.

b. The Quality Council oversees and evaluates the Virginia Mason Medical Center (VMMC) QAPI program and plan including the identification and promotion of current and emerging quality and safety focus areas unique to Virginia Mason Medical Center.

c. The Quality Council evaluates VMMC performance on national quality and safety goals and performance thresholds by Common Spirit Health.

d. The Quality Council reviewed action plans for underperforming measures and improvement efforts and ensures progress is made.

e. The Quality Council holds leaders and owners of improvement areas, committees, and workgroups accountable to established plans and performance indicators.

f. The Quality Council assists in removing barriers and assigning resources.

2. On 05/18/23 at 12:30 PM, Investigator #5, the Division Director of Acute Quality (Staff #511), the Quality Improvement Coordinator (Staff #512), the Interim Quality Program Manager (Staff #513), and the Division Vice-President of Quality and Safety (Staff #514) and members of the hospital's Quality Committee, reviewed the hospital's Quality Improvement Program including dashboards from 07/22 through 05/23 and committee minutes dated 01/31/23, 02/28/23, 03/28/23, and 04/25/23. Investigator #5 found no evidence the hospital collected or analyzed data related to restraint use.

3. At the time of the review, Staff #511 verified the finding and stated that there had been a change in staffing and that the hospital recognized that this was not being collected or reported. Staff #511 stated that it had been added to the new dashboard that would be rolled out next month.

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Based on interview and review of the hospital's quality and safety program, the hospital failed to develop a systematic process for creating, implementing, monitoring, and evaluating performance improvement action plans for identified deficiencies as directed by its quality improvement plan.

Failure to develop and implement corrective action plans for identified problems and monitor for sustained improvement limits the hospital's ability to provide high quality clinical care and improve patient outcomes.

Findings included:

1. Document review of the hospital's document titled, "Virginia Mason Medical Center Quality Council Charter, approved 04/25/23 showed the following:

a. The Quality Council provides oversight of the ongoing Quality Assessment and Performance Improvement (QAPI) Plan including the assessment and monitoring of quality and safety metrics, implementation of performance improvement activities, and the promotion of a culture of safety.

b. The Quality Council oversees and evaluates the Virginia Mason Medical Center (VMMC) QAPI program and plan including the identification and promotion of current and emerging quality and safety focus areas unique to Virginia Mason Medical Center.

c. The Quality Council evaluates VMMC performance on national quality and safety goals and performance thresholds by Common Spirit Health.

d. The Quality Council reviewed action plans for underperforming measures and improvement efforts and ensures progress is made.

e. The Quality Council holds leaders and owners of improvement areas, committees, and workgroups accountable to established plans and performance indicators.

f. The Quality Council assists in removing barriers and assigning resources.

2. On 05/18/23 at 12:30 PM, Investigator #5, the Division Director of Acute Quality (Staff #511), the Quality Improvement Coordinator (Staff #512), the Interim Quality Program Manager (Staff #513), and the Division Vice-President of Quality and Safety (Staff #514) and members of the hospital's Quality Committee, reviewed the hospital's Quality Improvement Program including dashboards from 07/22 through 05/23 and committee minutes dated 01/31/23, 02/28/23, 03/28/23, and 04/25/23. Review of a sample of the hospital dashboard and Quality Council meeting minutes dated 01/31/23, 02/28/23, 03/28/23, and 04/25/23 showed the following:

a. Central Line Associated Blood Stream Infections did not meet the hospital target for 4 of 5 months reported.

b. Catheter Associated Urinary Tract Infection did not meet the hospital target for 6 of 10 months reported.

c. Blood platelet transfusions with platelet counts above 100 thousand did not meet the hospital's target for 6 months of 10 reported months reported.

d. Percutaneous Coronary Intervention Mortality did not meet targets for Quarter 1 2022 and no further data collection was documented 10/22 through 04/23 (a period of 7 months).

e. OB: Maternal Hypertension Bundle Compliance did not meet target for 6 of 9 months reported.

f. OB: Low risk Primary Cesarean data showed the hospital did not meet target for 8 of 9 months reported.

g. Grievances closed within 7 days. The data showed the hospital did not meet its target for 3 of 3 months.

h. Timely review of incident reports by the facility showed the hospital did not meet its target for 10 of 10 months of data reported.

i. Medication errors showed the hospital did not meet its target for 10 of 10 months of data reported .

j. Preventable Adverse Drug Events showed the hospital did not meet its target for 10 of 10 months of data reported.

k. Oversedation showed the hospital did not meet its target for 10 of 10 months of data reported.

l. Smart Pump Library Compliance (% pump compliance) showed the hospital did not meet its target for 10 of 10 months of data reported.

m. Suicide: Trigger Assessment YES with Social Worker Note showed the hospital did not meet its target for 10 of 10 months of data reported.

n. Sepsis: Sepsis Bundle Compliance showed the hospital did not meet its target for 8 of 8 months of data reported.

o. Emergency Department: Left without Being Seen showed the hospital did not meet its target for 10 of 10 months of data reported.

Investigator #5 found no evidence that measurable and quantifiable actions/performance improvement initiatives were developed or implemented when the hospital data showed a trended failure to meet quality improvement goals.

Investigator #5 found no evidence the Quality Council reviewed underperforming measures that continued to underperform over time to ensure that action plans were developed, implemented, and progress was made.

3. At the time of the review, the Division Director of Quality stated that hospital's Quality Program had been completely transformed and a new charter had been developed. She stated that the new program was ready to roll out the next month and would include data collection and analysis, plan development and implementation, and reevaluation to ensure process improvement was being achieved. Staff #511 stated a new dashboard that would be rolled out next month.


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Based on interview, document review, and review of the hospital's quality and performance improvement program, the Governing Body failed to ensure that the hospital's Quality Improvement Committee had an effective system in place to evaluate and ensure that contracted patient care services were provided to patients in a safe and effective manner.

Failure to develop a coordinated process to oversee the performance of all patient care services and departments risks provision of improper or inadequate care and adverse patient outcomes.

Findings included:

1. Document review of the hospital's document titled, "Virginia Mason Medical Center Quality Council Charter, approved 04/25/23 showed the following:

a. The Quality Council provides oversight of the ongoing Quality Assessment and Performance Improvement (QAPI) Plan including the assessment and monitoring of quality and safety metrics, implementation of performance improvement activities, and the promotion of a culture of safety.

b. The Quality Council oversees and evaluates the Virginia Mason Medical Center QAPI program and plan including the identification and promotion of current and emerging quality and safety focus areas unique to Virginia Mason Medical Center.

c. The Quality Council oversees the quality of patient-facing contracted services.

2. On 05/18/23 at 12:30 PM, Investigator #5, the Division Director of Acute Quality (Staff #511), the Quality Improvement Coordinator (Staff #512), the Interim Quality Program Manager (Staff #513), the Division Vice-President of Quality and Safety (Staff #514), and members of the hospital's Quality Committee, reviewed the hospital's Quality Improvement Program including dashboards from 07/22 through 05/23 and committee minutes dated 01/31/23, 02/28/23, 03/28/23, and 04/25/23. Investigator #5 found no evidence that contracted services evaluation was integrated into the hospital's quality improvement program or that oversight was provided by the Quality Council.

3. At the time of the review, Staff #514 stated that there was an annual review process for contracts, but that it was not reported through Virginia Mason Quality Council.

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Based on observation, document review, and interview, the hospital failed to develop and implement an effective infection prevention and control program.

Failure to develop and implement an effective infection prevention and control program puts patients, staff, and visitors at risk of illness or communicable diseases.

Findings included:

1. The hospital failed to ensure staff followed hospital policy for peri-care for patients with an indwelling urinary catheter.

2. The hospital failed to ensure staff followed hospital policy regarding oral hygiene care for intubated and ventilated patients.

3. The hospital failed to ensure staff perform hand hygiene as required by policy.

4. The hospital failed to ensure staff followed manufacturer instructions for use when preparing detergent solutions for endoscopic reprocessing.

5. The hospital failed to ensure staff followed the hospital's policy for transporting endoscopes to prevent cross-contamination.

6. The hospital failed to ensure staff documented the liquid chemical germicide testing when reprocessing endoscopes.

Cross Reference: Tag A 0749

7. The hospital failed to ensure staff cleaned patient rooms upon discharge according to hospital policy and accepted standards of practice.

8. The hospital failed to protect clean supplies and equipment from sources of contamination.

9. The hospital failed to maintain a sanitary environment which was devoid of accumulated dust and debris and other potential sources of contamination.

10. The hospital failed to ensure staff followed the hospital's policy for uncleanable surfaces.

11. The hospital failed to implement a process to ensure unusable/expired supplies were not available for patient use.

12. The hospital failed to ensure staff implemented effective infection control and sanitation practices during cleaning of the operating rooms.

13. The hospital failed to ensure fan covers in the main kitchen were kept cleaned in a sanitary manner.

Cross Reference: Tag A 0750

Due to the scope and severity of deficiencies cited under §42 CFR 482.42, the Condition of Participation for Infection Prevention and Control and Antibiotic Stewardship Programs was NOT MET.
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Item #1 - Peri Care associated with Indwelling Urinary Catheters

Based on record review, interview, and review of hospital's policy and procedures, the hospital failed to ensure staff implement its policy for indwelling urinary catheter care as demonstrated by 8 of 10 records reviewed (Patient #301, #302, #303, #304, #501, #502, #504, and #505).

Failure to perform peri-care for patients with an indwelling urinary catheter creates risk for developing an infection.

Findings included:

1. Document review of the hospital document titled, "Inpatient Nursing Documentation Guidelines," no date, showed that basic inpatient nursing documentation for tubes and line care will be recorded every shift.

2. On 05/15/23 between 11:30 AM and 2:50 PM, Investigator #3 and the Nurse Manager (Staff #301) reviewed the medical records of three patients who had an indwelling urinary catheter. The review showed the following:

a. Patient #301 was a 65-year-old admitted to the hospital with septic shock (serious infection), multiple necrotic deep tissue wounds, and acute kidney injury. A review of indwelling catheter care from 05/05/23 to 05/14/23 showed that staff failed to document indwelling catheter care being performed for 10 of 20 shifts including:

05/04/23 No day shift
05/05/23 No day shift
05/06/23 No day shift
05/07/23 No day shift or night shift
05/09/23 No night shift
05/10/23 No day shift or night shift
05/11/23 No night shift
05/12/23 No night shift
05/13/23 No day shift or night shift

b. Patient #302 was a 76-year-old admitted to the hospital with a femur fracture following a fall with subsequent surgical repair. A review of indwelling catheter care from 05/11/23 to 05/14/23 showed that staff failed to document indwelling catheter care being performed for 6 of 8 shifts including:

05/11/23 No day shift or night shift
05/12/23 No day shift
05/13/23 No day shift or night shift
05/14/23 No night shift

3. At the time of the review, Investigator #3 interviewed a Nurse Manager (Staff #301) and a Registered Nurse (Staff #302) about peri care (usual cleaning associated with bladder and bowel function) for indwelling urinary catheters. Staff #302 stated it is performed at least every shift. Staff #301 confirmed the findings described above and acknowledged that catheter care should be performed and documented every shift.

4. On 05/15/23 between 3:00 PM and 4:00 PM, Investigator #3 and the Nurse Manager (Staff #303) of the medical oncology unit reviewed the medical record of Patient #303 who was transferred from another hospital with septic arthritis, endocarditis, multiple ischemic strokes, and a urinary tract infection (infection of the bladder). A review of indwelling catheter care from 05/08/23 to 05/14/23 showed that staff failed to document indwelling catheter care being performed for 10 of 14 shifts including:

05/08/23 No day shift or night shift
05/09/23 No day shift or night shift
05/10/23 No day shift or night shift
05/13/23 No day shift or night shift
05/14/23 No day shift or night shift

5. On 05/16/23 at 8:30 AM, Investigator #3 interviewed the Interim Chief Nursing Officer (Staff #305) and a Clinical Informaticist (Staff #306) about nursing documentation of peri-care being performed as part of indwelling urinary catheter care maintenance. Staff #306 stated the hospital was in the process of transitioning from contingency documentation (emergency/crisis procedures) to a new system-wide documentation process expected to be implemented in June 2023 which may account for some gaps in documentation described above. Staff #305 stated the expectation is that peri-care be performed every shift and as needed.

6. On 05/16/23 between 9:25 AM, Investigator #3 and the Nurse Manager (Staff #304) of the general surgery unit reviewed the medical record of Patient #304 who was a 61 year-old transferred from another hospital with a pelvic abscess. A review of indwelling catheter care from 05/13/23 to 05/15/23 showed that staff failed to document indwelling catheter care being performed for 6 of 6 shifts including:

05/13/23 No day shift or night shift
05/14/23 No day shift or night shift
05150/23 No day shift or night shift

7. On 05/16/23 at 9:59 AM, Investigator #5, the Clinical Manager of Oncology, Transfusion and Transplant Safety (Staff #501), the Transplant Manager (Staff #503), and the Critical Care Unit Interim Manager (Staff #504) reviewed the medical record for Patient #501 who was admitted to the Intensive Care Unit for the treatment of status post Esophagectomy for esophageal squamous cell carcinoma. The patient had a history of atrial fibrillation and was taking blood thinners, infection in the feeding tube site, cellulitis, hypertension, obstructive sleep apnea and memory loss. The patient was post-radiation and chemotherapy. The patient was intubated (had an endotracheal tube inserted into the airway) and on a ventilator at the time of the review. The patient had an indwelling urinary catheter placed on 05/02/23 prior to surgery. Investigator #5 and Staff #504 reviewed indwelling catheter care from 05/02/23 through 05/14/23. The review showed that staff failed to perform and document indwelling catheter care for 16 of 25 shifts reviewed including the following:

05/02/23 No night shift
05/03/23 No day shift or night shift
05/05/23 No day shift
05/06/23 No day shift or night shift
05/07/23 No day shift
05/08/23 No night shift
05/10/23 No day shift or night shift
05/11/23 No day shift or night shift
05/13/23 No day shift or night shift
05/14/23 No day shift or night shift

At the time of the review, Staff #504 confirmed the finding and stated that there was an opportunity to improve documentation of foley care.

8. On 05/16/23 at 10:13 AM, Investigator #5, the Clinical Manager of Oncology, Transfusion and Transplant Safety (Staff #501), the Transplant Manager (Staff #503), and the Critical Care Unit Interim Manager (Staff #504) reviewed the medical record for Patient #502 who was admitted to the hospital on 05/11/23 for concerns of septic shock and ischemic bowel (injury to the large or small intestine occurs due to not enough blood supply). The patient had coffee ground emesis and black stools. The patient had a history of alcohol use disorder, withdrawal seizures and bipolar disease. The patient had an indwelling urinary catheter inserted on 05/11/23 at 4:00 AM. Surveyor #5 and Staff #504 reviewed indwelling catheter care from 05/11/23 through 05/16/23. The review showed that staff failed to perform and document indwelling catheter care for 7 of 10 shifts reviewed including the following:

05/11/23 No day shift
05/12/23 No day shift
05/13/23 No day shift
05/14/23 No day shift or night shift
05/15/23 No day shift or night shift

At the time of the review, Staff #504 confirmed the findings and stated that foley catheter care should be performed each shift and as needed.

9. On 05/16/23 at 11:15 AM, Investigator #5, the Clinical Manager of Oncology, Transfusion and Transplant Safety (Statt #501) and the Transplant Manager (Staff #503), reviewed the medical record for Patient #504 who was admitted to the hospital on 05/11/23 for the treatment of pain, wound care, and worsening rash. The patient had been discharged earlier that day and had a history of neurosarcoidosis, diabetes, ventriculoperitoneal shunt placement with immunosuppressive therapy. The patient had an indwelling urinary catheter placed on 05/12/23 at noon. Surveyor #5 and Staff #501 reviewed indwelling catheter care from 05/12/23 through 05/15/23. The review showed that staff failed to perform and document indwelling catheter care for 7 of 7 shifts reviewed including the following:

05/12/23 No night shift
05/13/23 No day shift or night shift
05/14/23 No day shift
05/15/23 No day shift

10. On 05/16/23 at 11:29AM, Investigator #5, the Clinical Manager of Oncology, Transfusion and Transplant Safety (Staff #501) and the Transplant Manager (Staff #503), reviewed the medical record for Patient #505 who was admitted to the hospital on 05/04/23 for the treatment of sepsis, bacteremia ascites, and acute kidney injury. The patient had a history of metastatic intrahepatic and cholangiocarcinoma. The patient had an indwelling urinary catheter placed on 05/04/23 at 11:24 AM. Surveyor #5 and Staff #501 reviewed indwelling catheter care from 05/04/23 through 05/15/23. The review showed that staff failed to perform and document indwelling catheter care for 18 of 23 shifts reviewed including the following:

05/04/23 No night shift
05/05/23 No night shift
05/06/23 No night shift
05/07/23 No night shift
05/08/23 No night shift
05/09/23 No day shift or night shift
05/10/23 No day shift
05/11/23 No day shift or night shift
05/12/23 No day shift or night shift
05/13/23 No day shift or night shift
05/14/23 No day shift or night shift
05/15/23 No day shift or night shift

At the time of the review, Staff #501 verified the findings and stated there was an opportunity for improved documentation.

Item #2 - Oral Care/Oral Assessment

Based on observation, interview, and document review, the hospital failed to ensure that staff performed oral care/oral assessment for patient's intubated and on ventilators for 2 of 3 patients reviewed (Patient #501 and #503).

Failure to perform oral care for patients intubated and on ventilators increases the risk of infection, patient harm, and death.

Findings included:

1. Document review of hospital policy titled, "Clinical Protocol Mechanical Ventilator Management," approved 03/23, no policy number, showed the following:

a. Respiratory Therapists (RT) are responsible for performing oral care every 2 to 4 hours coordinating with nursing and to assess and document the condition of the patient's skin and mucosa integrity every 4 hours (with each ventilator check).

b. Joint responsibilities of RT and Nursing are to coordinate oral care per the ventilator bundle protocol.

c. Oral care is to be documented.

2. On 05/16/23 at 9:59 AM, Investigator #5, the Clinical Manager of Oncology, Transfusion and Transplant Safety (Staff #501), the Transplant Manager (Staff #503), and the Critical Care Unit Interim Manager (Staff #504) reviewed the medical record for Patient #501 who was admitted to the Intensive Care Unit for the treatment of status post Esophagectomy for esophageal squamous cell carcinoma. The patient had a history of atrial fibrillation and was taking blood thinners, infection in the feeding tube site, cellulitis, hypertension, obstructive sleep apnea and memory loss. The patient was post-radiation and chemotherapy. The patient was intubated (had an endotracheal tube inserted into the airway) and on a ventilator at the time of the review. Investigator #5 and Staff #504 reviewed oral care/ventilator care for 05/09/23, 05/10/23, 05/11/23, 05/12/23, 05/13/23, 05/14/23, and 05/15/23. The review showed that hospital staff failed to perform and document oral care/oral assessment every 4 hours per hospital policy for 5 of 7 days reviewed (05/11/23, 05/12/23, 05/13/23, 05/14/23, and 05/15/23).

3. At the time of the review, Staff #504 confirmed the finding and stated that oral care was performed by respiratory Therapy staff and should be completed every 4 hours.

4. On 05/16/23 at 10:36 AM, Investigator #5, the Clinical Manager of Oncology, Transfusion and Transplant Safety (Staff #501), the Transplant Manager (Staff #503), and the Critical Care Unit Interim Manager (Staff #504) reviewed the medical record for Patient #503 who was admitted on 05/11/23 for the treatment of atrial fibrillation with rapid ventricular response and a right cerebellar ischemic infarct (stroke). Investigator #5 and Staff #504 reviewed oral care/ventilator care for 05/11/23, 05/12/23, 05/13/23, 05/14/23, and 05/15/23. The review showed that hospital staff failed to perform and document oral care/oral assessment every 4 hours per hospital policy for 5 of 5 days reviewed (05/11/23, 05/12/23, 05/13/23, 05/14/23, and 05/15/23).

5. At the time of the review, Staff #504 confirmed the finding and stated there was an opportunity for improved documentation.

Item #3 - Hand Hygenie

Based on observation, document review, and interview, the hospital failed to ensure staff performed hand hygiene according to hospital policy and accepted standards of practice for 5 of 5 staff observations (Staff #307, 309, #505, #506, and Staff #508).

Failure to perform hand hygiene according to hospital policy to prevent transmission of infectious microorganisms puts patients and staff at increased risk of communicable illnesses.

Findings included:

1. Document review of the hospitals document titled, "Standard Precautions," last dated 02/20, no policy number, showed that staff are to perform hand hygiene prior to donning gloves and immediately after glove removal.

Document review of the hospital policy and procedure titled, "Hand Hygiene," no policy number, last reviewed 02/15/22, showed that the hospital references the electronic version of Elsevier for standard clinical procedures and processes and the Center for Disease Control (CDC) hand hygiene guidelines.

Document review of the hospital placard "Contact Precautions," dated 01/14, showed staff are to wash or sanitize hands at room entry and when leaving room.

2. On 05/15/23 at 12:25 PM, Investigator #5, the Clinical Manager of Oncology, Transfusion and Transplant Safety (Staff #501), the Transplant Manager (Staff #503), and the Critical Care Unit Interim Manager (Staff #504), inspected the Critical Care Unit. Investigator #5 observed a Provider (Staff #505) enter patient room J0911 wearing gloves. Staff #505 removed his gloves and retrieved a cell phone out of his pocket. Staff #505 pressed buttons and talked on the phone. Staff #505 failed to perform hand hygiene after he doffed his gloves. Staff #505, then put the phone back in his pocket and walked over to a glove box and donned a pair of gloves. Staff #505 failed to perform hand hygiene prior to donning gloves.

At the time of the observation, Staff #504 verified the finding and stated that he should have performed hand hygiene.

3. On 05/16/23 at 10:20 AM, during a tour of the Neurological, Neurosurgical, and Kidney Transplant unit, Investigator #3 and the Director of Acute Care Services (Staff #308) observed a housekeeper (Staff #309) exit a room posted for contact isolation for multi-drug resistant organisms (MDRO). Staff #309 did not remove her contaminated gloves and perform hand hygiene as required before proceeding to other housekeeping tasks.

At the time of the observation, Staff #308 verified the observation.

4. On 05/16/23 at 10:25 AM, during a tour of Neurological, Neurosurgical, and Kidney Transplant unit, Investigator #3 and the Director of the Acute Care Services (Staff #308) observed a medical provider (Staff #307) enter a room posted for contact isolation for multi-drug resistant organisms (MDRO) without performing hand hygiene prior to entering. Staff #307 was also reminded by Staff #308 to secure his personal protective gown around his waist upon entering.

At the time of the observation, Staff #308 verified the finding.

5. On 05/16/23 at 10:48 AM, Investigator #5, the Clinical Manager of Oncology, Transfusion and Transplant Safety (Staff #501) and the Progressive Care Manager (Staff #502), inspected the hospital's Progressive Care Unit. Surveyor #5 observed a Laboratory Phlebotomist (Staff #506) exit room #960 without performing hand hygiene and without wiping down her computer and cart. Staff #506 then donned gloves, grabbed an armband scanner off her cart, and entered room #968 without performing hand hygiene.

At the time of the observation, during an interview with Investigator #5, Staff #506 verified the finding and stated that she should have washed her hands.

6. On 05/16/23 at 1:30 PM, the Clinical Manager of Oncology, Transfusion and Transplant Safety (Staff #501) and the Manager of Float Pool, Staffing and House Supervisors (Staff #507) inspected the hospital's Emergency Department. Investigator #5 observed a Registered Nurse (Staff #508) place blood tubes in a biohazard bag then walk to a printer and remove paper out of the paper storage tray wearing the dirty gloves. Staff #508 then removed one glove grabbed a pen and wrote on the paper retrieved from the printer. Staff #508 then removed the other glove, grabbed a computer on wheels and exited the room. Staff #508 failed to perform hand hygiene after glove removal.

At the time of the observation, Staff #501 verified the finding.

Item #4 Endoscope manual cleaning

Based on document review, observation, and interview, the hospital failed to ensure that staff followed manufacturer instructions for use (MIFU) when preparing detergent solutions for endoscope reprocessing.

Failure to follow MIFU when preparing detergent solutions risks inadequate cleaning of endoscopes and puts patients at increased risk from infection.

Reference: Centers for Disease Control and Prevention (CDC) Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008, and the Healthcare Infection Control Practices Advisory Committee (HICPAC), updated May 2019. Enzyme solutions should be used in accordance with manufacturer's instructions, which include proper dilution of the enzymatic detergent.

Findings included:

1. Document review of the label instructions for Intercept Detergent showed that for endoscopes, Intercept should be mixed at 1 ounce to 3 gallons of water, and ensure a minimum contact time of 1 minute.

Document review of the Zutron Medical, Endo-Flush Operation Manual showed that users should be aware of the exposure time recommended by the manufacturer of the enzymatic or detergent being used in the cleaning process. It is essential that the channels of the endoscope being cleaned be exposed to the enzymatic or detergent per the manufacturer's instruction for use.

Document review of the hospital's policy titled, "Environmental Infection Prevention," no document number, approved 04/22, showed that all cleaning/disinfecting agents will be used according to the manufacturer's instructions with regard to dilution, compatibility, contact time, storage, and shelf life.

2. On 04/11/23 at 3:20 PM, Investigator #6 observed the decontamination processing of colonoscope by an Endoscope Reprocessor (Staff #617) in the Endoscope Decontamination Room of the Nephrology-Urology Clinic located on the 7th floor of the Buck Pavilion. The observation showed that Staff #617 mixed Intercept Detergent according to MIFU and used the Endo-Flush to flush the endoscope channels. While flushing the detergent solution, Staff #617 added fresh water to the solution thereby diluting the solution.

3. At the time of the observation, Investigator #6 interviewed Staff #617 about the process. Staff #617 stated that fresh water was added to the detergent solution so that the Endo-Flush did not draw air into the channels.

Item #5 Transporting Endoscopes

Based on observation, interview, and document review, the hospital staff failed to follow hospital's policy and procedures to prevent cross-contamination when transporting endoscopes.

Failure to prevent cross-contamination during transport places patients and staff at an increased risk of exposure to infectious microorganisms.

Findings included:

1. Document review of the hospital's policy titled, "Reprocessing of High-Level Disinfection," No Policy Number, Date Approved 05/10/23, showed that ANSI/AAMI ST58:2013 and OSHA 29 CFR 1910(d)(2)(xiii) are used as a reference. The policy indicated that the type of container that should be used depends on the items being transported. Bins with lids, enclosed or cover carts, rigid sterilization container systems and impermeable bags are among the types of containers that may be used alone or in combination to transport contaminated items. The policy also indicated that contaminated items must always be handled to minimize potential exposure of workers to disease producing microorganisms and contamination to the environment. Immediate containment and transport to a designated area minimizes the risk of employee contact with contaminates and allows the cleaning process to be performed in a controlled environment by personnel who are protected with appropriate personal protective equipment (PPE).

2. On 05/15/23 between the hours of 1:00 PM and 4:25 PM, Investigator #1 observed a piece of fiberboard duct taped over the pass-through window in the gastrointestinal unit (Jones 5 unit). The pass-through window is used to transport endoscopes from the decontamination room to the Medivator room (the clean room).

3. During the observation, Investigator #1 interviewed Staff #103 about the pass-through window and how do they transport the endoscope from the decontamination room to the Medivator room (the clean room). Staff #103 indicated that she would go into the decontamination room, pick up the bin with the endoscope and would walk it back to the Medivator room. The investigator asked if the endoscope was transported in a covered bin. Staff #103 indicated no. The investigator asked Staff #103 if there is a change of PPE when going from the Medivator room to the decontamination room then back to the Medivator room. Staff #103 indicated no. The investigator asked how long the window has been broken. Staff #103 indicated at least 2 years.

Item #6 Endoscope disinfection

Based on observation, interview, and document review, the hospital staff failed to document manufacturer's instructions for use of Liquid Chemical Germicide (LCG) testing when reprocessing endoscopes.

Failure to document the LCG testing in the reprocessing of semi-critical medical devices puts patients at risk from infection due to potentially inadequately disinfected equipment.

Findings included:

1. Document review of the hospital policy titled, "Reprocessing of High-Level Disinfection (HLD)," (effective date 05/10/23), showed that staff need to review manufacturer's instructions for use (IFUs) for the processing of the HLD device/equipment.

2. Document review of the manufacturer's instructions for use titled, "CER Endoscope Reprocessing CER-1/CER-2," showed that staff should complete the LCG testing before every reprocessing cycle, to ensure an adequate level of active ingredient and use the manufacturer's test strips to test the potency of the high-level disinfectant. If the high-level disinfectant is below minimum effective concentration, discard and replace it with fresh high-level disinfectant.

3. Document review of hospital's scope tracking log does not show documentation of LCG testing.

4. On 05/15/23 between 1:00 PM and 4:25 PM, Investigator #1 observed a gastrointestinal (GI) technician (Staff #102) as she performed reprocessing of a colonoscope. The investigator noticed that the Medivators in the GI unit (Buck 3 unit) did not produce a ticket like the ones in the sterile processing department. The Medivators in the sterile processing department produced a ticket that read that the disinfection process was "completed" and that the endoscope had "passed" or "failed".

5. During the observation, Investigator #1 interviewed Staff #102 on the process of verifying that the scope passed the disinfection process. Staff #102 showed the investigator the process by using the manufacturer's test strip that produced a color change to verify the disinfectant. Staff #102 confirmed that they do not document the disinfectant test.
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Item #1 Patient Room Discharge Cleaning

Based on document review, observation, and interview, the hospital failed to ensure that staff cleaned patient care areas according to hospital policy and accepted standards of practice.

Failure to comply with policies and procedures to prevent transmission of infectious organisms puts patients, staff, and visitors at increased risk from communicable diseases.

Findings included:

1. Document review of the hospital's unnumbered document titled, "Virginia Mason Team Medicine Standard Process Description: Discharge Cleaning," version 07/21, showed that Steps 1 - 23 include: 7. Wash walls and high dust; 9. Sanitize furniture and equipment in circular fashion around room from top to bottom; 11. Clean paper towel holder, mirror, sink. Ensure mirror allows for proper dwell time (2 mins.) prior to wiping any streaks.

Document review of the hospital's policy titled, "Inpatient Standard and Transmission-Based Precautions," no policy number, approved 03/22, showed that patient care equipment should be cleaned and disinfected between each patient use.

Document review of the Environmental Services (EVS) contractor (Crothall Healthcare) EVS Scope of Service - Frequency Table showed that daily cleaning, discharge/transfer cleaning, and as needed cleaning of patient rooms included thorough wiping of all furniture in the room. Discharge/transfer cleaning also included thoroughly washing & disassembling the bed.

2. On 04/11/23, between 10:46 AM and 1:50 PM, Investigator #6 observed a discharge cleaning of Patient Room #856 on the 8th floor of the Central Pavilion by Environmental Services Technician (Staff #612). The observation showed:

a. All surfaces of the patient/visitor recliner chair were not sanitized. The chair was not opened or reclined during the discharge cleaning.

b. The patient bed control panel on the foot board had an accumulation of grit in the corners.

c. Several surfaces around the room were not smooth and non-absorbent (cleanable):

i. Vinyl upholstery on patient/visitor recliner chair was worn and torn exposing cloth netting (an absorbent surface)

ii. Foam tape residue on the wall below a hook for the gait belt

d. Staff #612 wiped the mirror over the handwashing sink with a disinfectant cloth and immediately dried the mirror with a paper towel.

3. On 04/11/23 at 1:50 PM, Investigator #6 interviewed Staff #612 about the discharge cleaning process. During the conversation, Investigator #6 opened the recliner chair & observed stains from a dark liquid on the surface of the footrest. Staff #612 stated that she was not aware that the recliner chair opened. Staff #612 stated that she wiped the mirror with a paper towel to prevent streaks.

Item #2 Protection of Clean Supplies

Based on observation and interview, the hospital failed to protect clean supplies and equipment from sources of contamination.

Failure to prevent cross contamination during cleaning/reprocessing and storage of patient care supplies and equipment places patients and staff at increased risk of exposure to harmful microorganisms.

Findings included:

1. On 04/11/23 at 2:15 PM, Investigator #6 inspected the Dirty Utility Room in the Nephrology-Urology Clinic located on the 7th floor of the Buck Pavilion. The observation showed that an automated point of care urinalysis analyzer and a bottle of reagent strips for urinalysis were stored adjacent to the handwashing sink on the clean side of the room.

2. At the time of the observation, Investigator #6 interviewed the Medical Assistant/Lab Supervisor for the Unit (Staff #613) about the processes that were conducted in the dirty utility. Staff #613 stated that endoscopes from the Procedure Room were transferred to the Dirty Utility Room for preliminary manual cleaning and then transferred to the sterile processing department for decontamination and sterilization. Investigator #6 asked why the urinalysis supplies and equipment were set up at the handwashing sink (clean side) rather than the utility sink (dirty side) that has a splash guard to prevent splash contamination from the sink. Staff #613 stated that the room had never been set up that way.

3. On 04/11/23 at 2:30 PM, Investigator #6 inspected the Sterile Processing Department (SPD) Decontamination Room (SPD 342/343) located on the 3rd floor Central Pavilion. The observation showed that a garbage bin between the handwashing sink and a shelving unit for Personal Protective Equipment (PPE) was over-full such that soiled items were in contact with ready-to-use PPE; soiled gloves were on the floor around the garbage bin.

At 2:55 PM, Investigator #6 observed clean supplies (PPE) placed adjacent to the handwashing sink in the High-Level Disinfection (HLD) Endoscope Decontamination Room (SPD #365).

4. At the time of the observations, Investigator #6 interviewed the Director of Perioperative Services (Staff #615) and SPD Supervisor (Staff #616). Staff #616 stated that the garbage bins should be emptied before the garbage was above the bin. Staff #615 confirmed that clean supplies were placed adjacent to the handwashing sink & exposed to splash contamination.

5. On 04/11/23 at 3:20 PM, Investigator #6 inspected the Endoscope Decontamination Room in the Nephrology-Urology Clinic located on the 7th floor of the Buck Pavilion. The observation showed:

a. Clean supplies and endoscope reprocessing documentation were stored in the Decontamination Room (dirty side).

b. Towels placed on the counter around the decontamination sink were saturated.

c. A towel was placed under the pass-through window to the HLD Room (clean side) such that the towel was in both the dirty and clean rooms.

6. At the time of the observations, Investigator #6 interviewed the Endoscope Reprocessor (Staff #617) about the decontamination processes and use of the Decontamination Room. Staff #617 stated that the clean supplies and the towel under the pass through door had been set up in the room for as long as she had worked in reprocessing, and that the towels around the sink were replaced when they get too wet - once or twice during the shift.

7. On 04/11/23 at 4:30 PM, Investigator #6 inspected the Clean Utility Room (#1754) on the 7th floor of the Central Pavilion. The observation showed that a Vital Sign Monitor with blood oxygen saturation sensor (patient care equipment) had used sensor pads attached.

8. At the time of the observation, Investigator #6 interviewed the Telemetry Monitoring Technician (Staff #633) about the used patient care equipment. Staff #633 stated that the pads should have been removed when the monitor was disinfected prior to storage in the Clean Utility Room.

Item #3 Maintaining a Sanitary environment

Based on observation,interview, and document review, the hospital failed to maintain a sanitary environment.

Failure to maintain sanitary conditions that prevent accumulated dust and debris, and potential sources of contamination, puts patients, staff, and visitors at increased risk of exposure to allergens and harmful microorganisms.

Reference: Centers for Disease Control and Prevention (CDC) Guidelines for Environmental Infection Control in Health-Care Facilities (2003), updated 07/19: Part 1. E. Environmental Services b. Housekeeping surfaces require regular cleaning and removal of soil and dust. Part II E Recommendations - Environmental Services I. E. Keep housekeeping surfaces visibly clean on a regular basis.

Findings included:

1. Document review of the hospital's policy titled, "Environmental Infection Prevention," no policy number, approved 04/22, showed that horizontal surfaces in unoccupied and occupied rooms shall be damp-dusted or cleaned daily.

Document review of the hospital's policy titled, "Inpatient Standard and Transmission-Based Precautions," no policy number, approved 03/22, showed that patient care equipment should be cleaned and disinfected between each patient use.

Document review of the Environmental Services (EVS) contractor (Crothall Healthcare) EVS Scope of Service - Frequency Table showed that daily cleaning and as needed cleaning of common areas involved dust mopping all hard surfaced floors including corners, baseboards, and hard to reach areas; and ensuring all baseboards are free of dust, splash marks, and old finish.

2. On 05/15/23 between 11:15 AM and 4:14 PM, Investigator #6 toured Central Pavilion (CP) 15, CP 17, CP 6, and CP 7 with the Director of Quality & Safety (Staff #603) and the Quality Improvement Coordinator (Staff #604). The observations showed the following unsanitary areas:

a. CP 15:

i. storage room #1557 - dust & debris on the floor, compacted debris in the floor drain cover grate;

ii. storage closet in the hall opposite the nurses' station - accumulated dust (dustbunnies) on the floor;

iii. clean utility/medication/nourishment room across from patient room #1573 - stains on the floor below the patient nutrition refrigerator;

b. CP 17: clean utility - compacted debris in the floor drain cover grate;

c. CP 6: central supply (room #651) -medication refrigerator:

i. dust & debris on refrigerator chamber floor;

ii. dried drip marks on inside of refrigerator glass door;

iii. adhesive/tape residue on refrigerator chamber wall;

d. CP 7: soiled utility - pest trap and droppings/debris/stains on floor of under-sink cabinet

3. On 05/16/23 between 8:50 AM and 11:00 AM, Investigator #6 toured the Progressive Care Unit (Jones Pavilion) with the Director of Quality & Safety (Staff #603) and the Quality Improvement Coordinator (Staff #604). The observations showed the following unsanitary areas:

a. J0940 Nourishment Room:

i. debris on the counter surface encased below a splash guard installed on the left side of the hand washing sink;

ii. compacted dust in the air handler intake vent cover above the ice/water dispenser;

b. J0968 Nourishment Room:

i. accumulated dust (dustbunnies) along the splash coving behind the handwashing sink and the ice/water dispenser;

ii. compacted dust in the air handler intake vent cover above the ice/water dispenser;

c. J0970 Soiled Utility:

i. dust and debris on the floor;

ii. black debris on stainless steel braided hose below handwashing sink;

d. J0962 Supply Room - accumulated dust (dustbunnies) on the floor;

e. J0919 Patient Room (unoccupied/ready for use):

i. drip marks on IV pole stand;

ii. white marks on frames and compacted debris in mesh of 4 folding chairs stored on wall mount;

iii. supply cabinet shelf guides stained & dirty;

iv. compacted dust in the air handler intake vent cover above the handwashing sink;

f. J0972 Equipment & Supplies:

i. soiled linen & debris under linen cart;

ii. 2 of 4 suction canisters (ready for use) had sticky residue and ink marks on the outer surface;

g. J0973 Nourishment Room:

i. debris adhered to the wall above the refrigerator and counter;

ii. dark stain on the air handler intake vent cover;

h. J0975 Soiled Utility - dust accumulation at the air handler diffuser;

i. J0975 Medication Room - debris adhered to wall and floor below handwashing sink;

j. J0927 Patient Room (unoccupied/ready for use):

i. 1 of 2 suction canisters had ink marks on the outer surface & register connector was dirty;

ii. dirt & debris in the medication cabinet drawer glides.

4. At the time of the observations, Investigator #6 interviewed Staff #603 and Staff #604 about the unsanitary conditions. Staff #603 & Staff #604 confirmed the observations and stated that each of the areas should be cleaned more adequately.

Item #4 Uncleanable Surfaces

Based on observation, interview, and document review, the hospital failed to ensure that staff followed the hospital's environmental cleaning and infection prevention procedures.

Failure to implement environmental cleaning and infection prevention policies and protocols puts patients and staff at risk for infection, harm, and death.

Findings included:

1. Document review of the hospital's document titled, "Standard Precautions," no policy number, dated 02/20, showed that staff are to clean and disinfect all patient care equipment between each patient use.

Document review of the hospital's policy and procedure titled, "Environmental Infection and Prevention," no policy number, reviewed 02/15/22, showed the following:

a. Walls, windows, and doors shall be spot cleaned as needed and completely cleaned on a schedule that maintains visible cleanliness.

b. Report any evidence of leaks or stains to Engineering for repair.

c. Items with tears, cracks, and stains that cannot be removed or repaired must be discarded.

d. Single use medical equipment including single use devices must be discarded after use and not used for more than one patient.

e. Workstations on Wheels (WOW's) must be cleaned before and after being taken into a patient's room.

2. On 05/15/23 at 11:50 AM, Investigator #5, the Clinical Manager of Oncology, Transfusion and Transplant Safety (Staff #501), the Transplant Manager (Staff #503), and the Critical Care Unit Interim Manager (Staff #504), inspected the Family Conference Area. Investigator #5 observed significant areas of worn, cracked, torn, and uncleanable fabric covering the seat cushions on 5 chairs, 1 loveseat, and 1 couch type furniture in the Family Conference Area.

3. At the time of the observation, Staff #504 verified the finding and stated she would report the worn furniture.

4. On 05/15/23 at 12:45 PM, Investigator #5 and the Clinical Manager of Oncology, Transfusion and Transplant Safety (Staff #501), the Transplant Manager (Staff #503), and the Critical Care Unit Interim Manager (Staff #504), inspected the Critical Care Unit. Investigator #5 observed a used N95 mask laying on a computer on wheels outside room J0922.

5. At the time of the observation, Staff #504 verified the finding and discarded the used mask.

6. On 05/16/23 at 8:25 AM, Investigator #5, the Clinical Manager of Oncology, Transfusion and Transplant Safety (Staff #501), the Transplant Manager (Staff #503), and the Critical Care Unit Interim Manager (Staff #504), inspected the Surgery waiting room at Linderman Pavilion. Investigator #5 observed a couch with seating cushions that were cracked worn, torn, and uncleanable.

7. At the time of the observation, Staff #504 verified the finding.

8. On 05/16/23 at 10:48 AM, Investigator #5, the Transplant Manager (Staff #503), and Progressive Care Manager (Staff #502) inspected the hospital's Progressive Care Unit. Investigator #5 observed a Laboratory Phlebotomist (Staff #506) exit room #960 without wiping down her computer and cart. Staff #506 then donned gloves, grabbed an armband scanner off her cart, and entered room #968 without wiping down the scanner after leaving the prior room or entering the current room.

9. At the time of the observation, during an interview with Investigator #5, Staff #506 verified the finding and stated that it was hospital policy to wipe down the machine after exiting the room.

10. On 05/16/23 at 2:00 PM, Investigator #5, the Clinical Manager of Oncology, Transfusion and Transplant Safety (Staff #501) and the Manager of Float Pool, Staffing, and House Supervisors (Staff #507) inspected the hospital's Emergency Department. Investigator #5 observed multiple doors on pass throughs and in patient rooms where trim and laminate were coming off/apart from the doors, areas of duct tape on walls, tape holding down trim on doors, and areas where duct tape was removed which also removed the paint making the walls uncleanable. Areas with uncleanable surfaces included rooms J0701, J0702, J0703, J709, J010, J0712, J0714, J0715, J0716, J0717, J0718, and J0719.

11. At the time of the inspection, Staff #507 verified the findings and stated that work orders had been placed to replace the doors on the outside rooms.

Item #5 Unusable Supplies

Based on observation, interview, and document review, the hospital failed to implement a process to ensure unusable/expired supplies were not available for patient use.

Failure to monitor and establish a systematic process for ensuring that expired and unusable patient care supplies are not used for patient care risks infection, harm, and death.

Reference:

McKesson Piston Irrigation Syringe manufacturer's instructions, dated 2023, showed that, "Individually packaged, disposable design to conveniently peel open and discard after use."

Stat Strip Express GLU Testing Strips manufacturer's instructions showed that quality control open vial stability is 90 days and test strip open vial stability is 180 days.

Findings included:

1. Document review of the hospital's document titled, "Guidance for Dating Medications and Supplies," dated 11/18/20, no policy number, showed the following:

a. Sterile water for irrigation is single use only and once opened it must be disposed of after use.

b. Avoid using secondary containers. If a secondary container must be used, it should be labeled with the contents and the date filled.

2. On 05/15/23, Investigator #5, the Clinical Manager of Oncology, Transfusion and Transplant Safety (Staff #501), the Transplant Manager (Staff #503), and the Critical Care Unit Interim Manager (Staff #504), inspected the Critical Care Unit. Investigator #5 observed the following:

a. At 12:02 PM, during inspection of Room J903, Investigator #5 observed 1 open bottle green top chemstick glucometer checking solution undated, 1 bottle red top chemstick glucometer checking solution with an unreadable expiration date, and 1 undated bottle of blood glucose strips. Investigator #5 also observed 1 single use irrigation syringe used for flushing nasogastric tubes dated 05/13/23 at 5:30 AM and a specimen type cup dated 05/13/23 at midnight.

At the time of the observation, Staff #504 verified the finding and stated that the chemstrip solutions should have been dated with the expiration date. Staff #504 stated that hospital policy is for syringes for flushing nasogastric tubes should be changed every 24 hours and verified that the observed syringe should have been discarded and that the glucometer testing solutions should be dated 90 days from opening.

b. At 12:27 PM, during inspection of room J0915, Investigator #5 observed an irrigation syringe for flushing the nasogastric tube was unlabeled and undated. In addition, a specimen cup with scant clear fluid in the bottom was unlabeled and undated.

c. At 12:30 PM, during inspection of room J916, Investigator #5 observed a bottle of Braun sterile water for irrigation open and partially used. The bottle was dated 05/14 at 9:00 AM. Next to the bottle of saline, was an unlabeled and undated irrigation syringe and an unlabeled and undated specimen type cup containing a clear fluid. Investigator #5 observed 1 open bottle green top chemstick glucometer checking solution and 1 bottle red top chemstick glucometer checking solution both undated.

3. At the time of the observation, Staff #504 verified the finding including the verification of the directions on the front of the bottle of Saline that stated, "Single unit container, Discard unused portion."

Item #6 Operating room terminal cleaning

Based on document review, observation, and interview, the hospital failed to implement effective infection control and sanitation practices during cleaning of Operating Rooms.

Failure to effectively clean the Operating Rooms places patients and staff at risk of exposure to harmful microorganisms.

Resources: Association of peri-Operative Registered Nurses (AORN) Guidelines for Perioperative Practice: Environmental Cleaning (2020) - Recommendation 2. Cleaning Procedures; 2.5 Perform cleaning activities in a methodical pattern that limits the transmission of microorganisms; progress from clean to dirty with the same cleaning material; progress from top to bottom when cleaning and damp dusting. 2.8 Always consider floors in the perioperative practice setting to be contaminated.

Recommendation 4. OR and Procedure Rooms 4.2 Operating and procedure rooms must be cleaned and disinfected after each patient procedure 4.2.3 Clean and disinfect all items used during patient care. 4.4.1 Clean and disinfect the exposed surfaces of all items.

Recommendation 12.2. Maintain the integrity of structural surfaces (e.g., doors, floors, walls, ceilings, cabinets) and have surfaces repaired when damaged. 12.2.1 ...Damaged structural surfaces may create a reservoir for the collection of dirt and debris that cannot be removed during cleaning.

Findings included:

1. Document review of the hospital's policy titled, "Environmental Infection Prevention," no policy number, approved 04/22, showed that cleaning of operating rooms and other rooms in which invasive procedures are performed was according to published perioperative standards and recommended practices. The cleaning and disinfection procedure included wiping or scrubbing all surfaces to remove organic matter and soil prior to disinfection, and cleaning is to occur from the least soiled to the most soiled surface and from the highest to the lowest surface.

Document review of the Environmental Services (EVS) contractor (Crothall Healthcare) EVS Scope of Service - Frequency Table showed that multiple times per day and as needed cleaning of Operating Rooms (OR) involved spot cleaning walls, doors, door frames, surfaces, and fixtures throughout the OR during Between Case Cleaning and Terminal Cleaning Procedures.

2. On 05/15/23 between 6:10 PM and 7:15 PM, Investigator #6 observed the terminal cleaning of OR #1 by 3 EVS technicians (Staff #634, Staff #635, and Staff #636). The observation showed:

a. disinfected pads from the procedure bed were placed on undisinfected surface to dry, the pads were not re-disinfected;

b. EVS technician's hair came into contact with previously disinfected electrical cords hanging on an IV pole, the surfaces were not re-disinfected;

c. disinfected parts of the disassembled procedure bed were placed on the floor to dry, the surfaces were not re-disinfected;

d. ceiling mounted procedure lights were disinfected above previously disinfected bed pads, the bed pads were not re-disinfected;

e. a clean linen bag secured to a rolling linen hamper frame dragged along the floor as it was rolled into the OR from the perioperative area;

f. 3 protective lead apron/vests stored on wall pegs were not disinfected and also came into contact with the floor mop;

g. bits of debris adhered to the wall surface around the stainless steel fire suppression panel;

h. tape residue adhered to a suction canister, movable cart, and walls of a built-in stainless steel supply cabinet;

i. dust build-up on top of a Fire Extinguisher triangle sign secured to the wall, and on a ceiling air handler diffuser;

j. ink smears around a wall mounted white board were not removed by disinfectant mop;

k. floor tile coving was stained and chipped in several areas around the OR;

l. the floor below a stationary supply cabinet was not dusted or mopped;

m. procedure bed pads with tears in the vinyl cover, anesthetists chair with cracked vinyl upholstery;

n. chipped edges on procedure bed deck, broken and chipped surfaces of hamper clips;

3. At 7:15 PM, Investigator #6 interviewed Staff #634, Staff #635, Staff #636, and the EVS Director (Staff #611) about the observations and cleaning procedures. Staff #611 confirmed the observations and stated that the EVS team should follow a pattern of cleanest to dirtiest and high to low. The investigator asked about the cleaning frequency of the ceiling and hard to reach areas of the floor and walls. Staff #634 stated that there are generally 4 EVS technicians performing an OR terminal cleaning, but they are short staffed. He stated that he thinks the ceiling was cleaned about 2 weeks ago. The investigator asked about the procedure for reporting items that need to be repaired or replaced. Staff #635 stated that the EVS staff should tell the manager.

Item #7 Soiled Fan Covers

Based on observation, interview and document review, the hospital staff failed to ensure that the fan covers are kept clean in a sanitary manner in the main kitchen.

Failure to maintain a sanitary environment in the main kitchen puts patients, staff, and visitors at risk of food borne illness.

Findings included:

1. On 05/16/23 between 9:20 AM and 10:45 AM, Investigator #1 and the Dietary Manager (Staff #101) toured the dietary department. The observation showed dust accumulation and debris build-up on the fan covers in the walk-in refrigerator.

2. At the time of the observation, Staff #101 stated that she will notify facility maintenance.

References: FDA Food Code 4-6011; Washington State Retail Food Code, WAC 246-215-04600(3): Nonfood contact surfaces of equipment must be kept free of an accumulation of dust, dirt, food residue, and other debris.
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