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Based on observation, interview, and record review, the GB failed to assume responsibility for determining, implementing, and monitoring policies governing the hospital's total functions to ensure compliance with COPs under 482.42 (Infection Prevention and Control and Antibiotic Stewardship Programs).

The GB failed to ensure an effective, active hospital-wide infection control program for the prevention, control, and investigation of infections and communicable diseases, including COVID-19. Cross reference to A747.

The cumulative effect of these systemic practices resulted in the failure of the hospital's GB to ensure the provision of quality healthcare in a safe manner.

Based on interview and record review, the GB failed to ensure the written agreement between the hospital and telemedicine neurology physicians group included a provision that the neurology physicians group would provide clinical services that complied with all CMS COP's. This increased the risk the hospital may not be in full compliance with all CMS COP's.

Findings:

Review of the hospital's P&P titled Rules and Regulations of the Governing Board of Fountain Valley Regional Hospital and Medical Center dated 5/29/18, showed in part, "...The functions and duties of the GB...consistent with the standards of The Joint Commission on Accreditation of Healthcare Organizations...and applicable laws and regulations..."

Review of the hospital's P&P titled Bylaws, general rules and regulations of the medical staff dated 3/2019 showed in part, "...Telemedicine Practitioner means any licensed and appropriately credentialed practitioner who only prescribes, renders a diagnosis or otherwise provides clinical treatment to a hospital patient by telemedicine who has expressly applied for and been granted Telemedicine privileges. Telemedicine practitioners must meet the qualifications for membership outlined in Article II, Section 2.2..."

Review of the Contract Services Evaluation Executive Summary dated 10/24/19, showed, "The governig body has the responsibility for assuring that hospital services are provided in compliance with the Medicare Conditions of Participation and according to acceptable standards of practice irrespective of whether the services are provided directly by the hospital emplyees or indirectly by contract..."

Review of the Emergency Room On-Call Agreement for stroke patients dated 11/22/19, showed no documented evidence of the statement that the neurology physicians group would provide clinical services that complied with all CMS COPs.

During an interview with the Director of the Medical Staff on 7/21/20 at 0945 hours, she agreed with the finding.

Based on interview and record review, the GB failed to ensure the complete list of all contracted services provided in the hospital was maintained. This created the increased risk of substandard services being provided.

Findings:

Review of the hospital's P&P titled Rules and Regulations of the Governing Board of Fountain Valley Regional Hospital and Medical Center dated 5/29/18, showed in part, "...The Governing Board shall review at least annually (i) the quality of service rendered by hospital-based physicians and other professional service contractors, and (ii) the need for and selection of such hospital-based physicians and professional service contractors..."

Review of the hospital's contracted services list was initiated on 7/16/20. The contracted services list included all contracts for clinical services, but the non-clinical vendors were not listed.

During an interview with the Director of Quality on 7/16/20 at 1015 hours, the Director of Quality provided the list of contracted services showing only clinical contracted services. However, the Director of Quality was unable to provide the complete list of contracted services which included the non-clinical contracted services.

Based on observation and interview, the hospital failed to ensure the privacy was provided to one of 25 sampled patients (Patient 25) during the medical treatments. This had the potential to violate the patient's privacy right during the medical treatment.

Findings:

On 7/14/2020 at 1225 hours, during the PICU tour with the Director of ICU/DOU. The PICU was observed to be used for the MICU and DOU adult patients. There were eight private patient rooms and one shared room. The shared room was occupied by three MICU patients in Beds 9, 10, and 11. Each bed had the patient privacy curtains. The following was observed:

- For Bed 9, the patient was ambulating at the bedside with assistance.

- The patient in Bed 10 had an IV medication infusion.

- For Bed 11, Patient 25 was on hemodialysis. The dialysis nurse was observed working on the patient's dialysis access site.

However, there was no privacy curtain used to provide the privacy during the time Patient 25 receiving dialysis treatment. The Director ICU/DOU confirmed the observation.

Based on observation, interview, and record review, the facility failed to provide care in a safe environment based on the infection control standards of practice for the patients on the Medical Pulmonary unit of the East Tower, Medical Telemetry of the main hospital building, DOU, Pediatric unit, PICU, and MICU. This failure had the potential for cross contamination for the non-COVID patients to be exposed to the COVID-19 positive patients.

Findings:

Interim Infection Prevention and Control Recommendations for Patients with Suspected or Confirmed Coronavirus Disease 2019 (COVID-19) in Healthcare Setting updated 5/18/20, showed to keep the patients and healthcare personnel (HCP) healthy and safe, it is generally recommended that the patients with COVID-19 be transferred to a separate area of the facility where they can be cared for by the dedicated HCP. Dedicated means that HCP are assigned to care only for these patients during their shift.

On 7/14/20, review of the hospital's P&P for Preparedness and Response to Pandemic Viruses, effective on 5/2018 showed one of the procedures would be no "Cohorting."

In a pandemic situation, large numbers of patients might present to the hospital and all available Airborne Isolation Rooms might be filled. Infection Control might deem it necessary to cohort patients on an isolation ward (in-hospital or alternative site) by following Health and Human Services (HHS) guidelines with "designated areas or units used for cohorting pandemic viruses to prevent cross-transmission of respiratory viruses, whenever possible, and only patients with confirmed pandemic virus to the same room or isolation unit. Assigned personnel should not float to other patient care areas and the number of personnel entering the cohorted area would be limited, because of the high patient volume anticipated during a pandemic; cohorting would be implemented early in the course of a local outbreak.

1. On 7/14/20 at 1100 hours, a tour of the Medical Pulmonary unit located on the second floor of the East Tower was conducted with the RN Manager of 2/3 East Tower. Rooms 254, 258, 260, 262, 282, 284, 286, and 290 A were COVID-19 positive patient rooms with two PUI patient rooms, Rooms 282 and 290 B.

On 7/14/20 at 1100 hours, an interview was conducted with the RN Manager 2-3 East Tower. The RN Manager 2-3 East Tower stated the COVID-19 and PUI patients were not cohorted (a grouping of patients with a given infection within an isolated area together in the same area and it was not possible to have assigned dedicated nursing staff for COVID-19 and PUI patients.

2. On 7/14/20 at 1247 hours, an initial tour of the Medical Telemetry unit on the second floor of the main hospital building was conducted with the Director of Telemetry. The Director of Telemetry stated the current census on the unit were 42 patients which included 15 COVID-19 positive patients. During the tour, the rooms of the COVID-19 positive patients were observed not being cohorted in one area of the telemetry unit.

On 7/14/20 1400 hours, the Manager of Quality was asked to identify the COVID-19 positive patients on the floor map of the Medical Telemetry Unit. Review of the identified COVID patient room on the floor map showed the COVID-19 positive patients rooms were Rooms 203, 204, 205, 210, 219, 221, 223 A and B, 224, 225, 226, 227, 231, and 234. These COVID-19 patients rooms were not cohorted in one area of the unit.

On 7/15/20 at 0900 hours, a tour of the Medical Telemetry floor on the second floor in the main hospital was conducted with the Director of Telemetry. Rooms 201, 202, 203, 204, 209, 210, 219, 221, 223, 224, 225, 226, 227, 231, and 234 were the COVID-19 positive patient rooms.

On 7/15/20 at 0930 hours, an interview was conducted with the Med/Tele Director of Telemetry. The Director of Telemetry stated the COVID-19 and PUI patients were not cohorted on the unit, and the staff had to take care of both COVID-19 and non-COVID patients.


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3. On 7/15/2020 at 1019 hours, during the tour in the DOU with the Director of Rehab/Bariatrics and Manager of PACU/Pre-Op. Patient 12 who was the negative COVID-19 patient was observed ambulating in the hallway with the physical therapist. Further observation showed the patient rooms next to Patient 12's room on both side were the COVID-19 positive isolation rooms.

4. On 7/17 /2020 at 0750 hours, the Pediatric unit was toured. The board in the unit showed there were four patients admitted. During the concurrent interview with Pediatric Unit Secretary, she stated the unit had four patients, including one patient with positive COVID-19. This positive COVID-19 patient room was next to the COVID-19 negative patient.

5. On 7/17/2020 at 0758 hours, the PICU was toured with the Manager of Quality. The PICU board showed seven patients were on the unit as follows:

- Two pediatric COVID-19 negative patients were in Rooms 2 and 4.
- Four MICU adult patients included one COVID-19 positive in Room 6 and three COVID-19 negative in Beds 9, 10, and 11.
- One adult DOU COVID-19 negative patient who required contact isolation was in Room 8.

6. On 7/17/2020 at 0816 hours, the MICU was toured with the Manager of Quality and Director of ICU/ DOU. The MICU board showed the census was 18 patient. The unit had some private rooms (Rooms 10-17) and sections with the patient beds (#18-#28) separating by the privacy curtains or clear plastic dividers. The following was observed:

- Rooms 10 and 11 had the negative COVID-19 patients.
- Room 15 had the PUI patient.
- Rooms 12, 14, 16, and 17 had the positive COVID-19 patients.
- The sections for Bed #18 - #28 (with privacy curtain/dividers) had the positive COVID-19 patients.

The Director of ICU/DOU confirmed the findings.

On 7/16/20 at 1115 hours, the hospital's Administration was informed of the identified concerns related to the COVID-19 positive patient rooms were scrattered through out the units and no dedicated staff only assigned to the COVID-19 positive patients.

On 7/20/20 at 1100 hours, during the QAPI meeting with the hospital's adminstration staff, the CNO presented to the survey team the hospital's plan to cohort the COVID-19 positive patients with the assgined dedicated staff for the hospital's immediate implementation.

Based on observation, interview and record review, the facility failed to identify and include ineffective hospital operational processes as an opportunity for improvement in their quality improvement activities related to COVID-19.

Findings:

According to the CDC Interim Infection Prevention and Control Recommendations for Healthcare Personnel during the Coronavirus Disease 2019 (Covid-19) Pandemic dated 7/15/20, showed in part, "...As a measure to limit HCP exposure and conserve PPE, facilities could consider designating entire units within the facility, with dedicated HCP, to care for patients with suspected or confirmed SARS-COV-2 infection. Dedicated means the HCP are assigned to care only for these patients during their shift..."
Review of the hospital's P&P titled Performance Improvement Plan 2020 showed in part, "...The data collected for priority and required areas are used to monitor the stability of existing processes, identify opportunities for improvement, and identify changes that lead to improvement and to sustain improvement..."

Review of the hospital's P&P titled Rules and Regulations of the Governing Board of Fountain Valley Regional Hospital and Medical Center dated May 29, 2018, showed in part, "...The Governing Board shall require the Medical Staff and staffs of the Hospital departments/services to implement and report on the activities and mechanisms for monitoring and evaluating the quality of patient care, for identifying opportunities to improve patient care, and for identifying and resolving problems...(ii) use of planned and systematic procedures to objectively assess the quality of care provided, (iii) implementation of corrective action when problems or opportunities for improvement are identified..."

Review of the hospital's P&P titled FVRH Infection Control FAQ's dated 4/8/20, showed in part, "...Cohorted Units. For Cohorted units with patients known to be infected with the same infectious disease (Covid 19 positive) when these patients are housed in the same location (i.e., Covid-19 patients residing in an isolation cohort)...Wear the same gown, facemask and face shield for repeated close encounters with several different patients..."

Review of the hospital's P&P titled FVRH Infection Control FAQ's dated 5/29/20, showed in part, "...Cohorted COVID units. For cohorted units with patients known to be infected with the same infectious disease (Covid 19 positive)..."

Review of the hospital's P&P titled Management of Health Care Personnel Potentially Exposed to COVID-19 PUI or Case, undated, showed in part, "...Restrict entry to room to necessary caregivers only...Assign limited staff to provide care to possible cases..."

Review of the CMS QSO-20-13 dated 3/30/20, showed in part, "...Plan for a surge of critically ill patients and identify additional space to care for these patients. Include options for...Separating known or suspected COVID-19 patients from other patients ("cohorting"). Identifying dedicated staff to care for COVID-19 patients..."

1. The hospital failed to assign the dedicated nursing staff to the COVID-19 positive patients that required transmission-based precautions. Cross reference to A397.

2. The hospital failed to ensure the monitoring of COVID-19 patients room placement to be physically separated from the non-COVID-19 patients and assignment of the dedicated staff as per the hospital's P&P. Cross reference to A749, example #1.

During an observation on 7/14/20 at 1145 hours, on the OB unit, RN L showed the "Covid room" which was designated for the Covid-19 positive patients only. During a concurrent interview, she stated, "The Covid-19 positive patient's nurse is not restricted to that one patient (Covid-19 positive), she can help other patients (Covid-19 negative). "We all know how to use PPE, we are all educated."

During a group infection control interview on 7/14/20 at 1511 hours, the Director of Quality was asked if he recommended the RNs and CNAs, who assigned to take care of the Covid-19 positive patients, should also take care of the Covid-19 negative patients as well. The Director of Quality stated, "No."

During a telephone group interview on 7/17/20 at 1120 hours, the CNO stated, "The hospital follows the transmission-based precautions, not follow the disease." When the CNO was asked about the care of the Covid-19 positive patients without the dedicated staff assigned to the only COVID-19 positive patients, she stated, "Sometimes, it is not possible to do cohorting the patients with this surge."

Based on observation, interview, and record review, the hospital failed to provide the dedicated nursing staff to the COVID-19 positive patients that required isolation for to a highly infectious disease. This failure had the potential to spread this infectious disease to other patients and staff.

Findings:

The CDC's guidelines titled Coronavirus Disease 2019 showed the facilities should designate units with dedicated (assigned to care for only COVID-19 patients) HCP to care for the patients with known or suspected COVID-19.

Interim Infection Prevention and Control Recommendations for Patients with Suspected or Confirmed Coronavirus Disease 2019 (COVID-19) in Healthcare Setting updated 5/18/20, showed to keep the patients and HCP healthy and safe; it is generally recommended that the patients with COVID-19 be transferred to a separate area of the facility where they can be care for by the dedicated HCP. Dedicated means that HCP are assigned to care only for these patients during their shift.

On 7/14/20 at 1000 hours, a tour of the Medical Pulmonary unit located on the East Tower was conducted with the RN Manager 2-3 East Tower. The COVID-19 positive patient rooms were scattered throughout the unit, not cohorting in the same area on the unit. Cross reference to A144, example #1.

On 7/14/20 at 1100 hours a document review was conducted with the RN Manager 2-3 East Tower. Review of the Staffing Assignment by Room list showed the staff took care of COVID-19/PUI patients and non-COVID patients.

On 7/14/20 at 1100 hours, an interview was conducted with the RN Manager 2-3 East Tower. The RN Manager 2-3 East Tower stated the COVID-19 positive and PUI patients were not cohorted and it was not possible to have assigned the dedicated nursing staff for the COVID-19 and PUI patients.

2. On 7/15/20 at 0900 hours, a tour of the Medical Telemetry unit (second floor) in the main hospital was conducted with the Director of Telemetry. The COVID-19 positive patient rooms were in different area throughout the Medical Telemetry floor. Cross reference to A144, example #2.

On 7/15/20 at 0930 hours, an interview was conducted with RN 4. RN 4 stated there have been times when she had the COVID-19 positive and non-COVID patients to care for during her shift.

On 7/15/20 at 1000 hours, an interview was conducted with the Director of Telemetry. The Director of Telemetry stated the COVID-19 patients were not "cohorted" in a certain area of the unit because the facility did not like moving the patients around and she did not always have the dedicated staff for the COVID-19 patients due to staffing shortages.

On 7/16/20 at 1400 hours, an interview was conducted with the CNO. The CNO stated having the dedicated staffing for COVID-19 and PUIs were not always possible due to staffing shortages and the CDC's guidelines were only suggestions.

Based on observation, interview, and record review, the hospital failed to ensure an effective, active hospital-wide infection control program for the prevention, control, and investigation of infections and communicable diseases, including COVID-19 as evidenced by:

1. The hospital failed to assign the dedicated nursing staff to care for the COVID-19 positive patients who required transmission-based precautions. Cross reference to A397.

2. The hospital failed to ensure the active infection control surveillance were in place to monitor compliance with the current hospital's P&P and CDC's guidelines. Cross reference to A749.

The cumulative effects of these systemic problems resulted in the hospital's inability to provide an effective hospital wide infection control program and increased the risk of cross contamination and the spread of infection in the facility.

Based on observation, interview, and record review, the hospital failed to ensure the active infection control surveillance were in place to monitor compliance with the current hospital's P&P and CDC's guidelines as evidenced by:

1. Failure to ensure the monitoring of COVID-19 patients room placement to be physically separated from the non-COVID-19 patients and assignment of the dedicated staff as per the hospital's P&P.

2. Failure to ensure the staff reported the COVID-19 exposure and signs and symptoms related to COVID-19 to the managers.

3. Failure to ensure the infection control surveillance tools were effectively used to collect accurate data.

4. Failure to ensure the patient worn a mask during the blood drawing procedure and the high touch area was disinfected after the blood drawing procedure.

5. Failure to ensure the privacy screen was in place to separate the pediatric and adult patient areas.

6. Failure to ensure the used gowns were properly placed.

7. Failure to provide the separate breakrooms and restrooms for the staff who assigned to the COVID-19 positive patients.

8. Failure to ensure the hand hygiene was performed by the physicians after seeing the patients.

These failures created the risk of cross-contamination and spread of infection.

Findings:

1. On 7/14/20, review of the hospital's P&P on Preparedness and Response to Pandemic Viruses, effective on 5/2018, showed no "Cohorting."

In a pandemic situation, large numbers of patients might present to the hospital and all available Airborne Isolation Rooms might be filled. Infection Control might deem it necessary to cohort patients on isolation ward (in-hospital or alternative site) by following Health and Human Services (HHS) guidelines....Designated areas or units would be used for cohorting pandemic virus to prevent cross-transmission of respiratory viruses, whenever possible, assign only patients with confirmed pandemic virus to the same room or isolation unit....... Assigned personnel should not float to other patient care areas and the number of personnel entering the cohorted area would be limited......Because of the high patient volume anticipated during a pandemic, cohorting would be implemented early in the course of a local outbreak.

Concurrent review of the hospital's FAQs showed, "Cohort only confirmed cases with the same disease process." The patient would be placed in a single room with door closed.

* Review of the hospital's timeline on 7/20/20, showed the following:

- On 3/16/20, the PUI patients were moved to the Telemetry/Med Surg unit of the East Tower to create a designated unit. Non-PUI patients would be moved out of the Telemetry/Med Surg unit of the East Tower.

- On 4/14/20, the East tower was closed - all patients moved back to the main hospital.

- On 6/2/20, opening 3E (third floor of East Tower) - COVID-19 unit.

- On 6/22/20, opening 4E (fourth floor of East Tower) - Oncology unit.
6/29/20, opening 2E (second floor of East Tower) - Medical Pulmonary.

On 7/17/20 at 1000 hours, the diagrams of the hospital's units showing the highlighted COVID-19 and PUI patient rooms were reviewed with Director of Quality and showed the COVID-19 positive patient rooms were scattered throughout the units as follows:

- The ICU was fulled with the COVID-19 positive patients, with four COVID-19 positive patients overflowed to the Med-Surg unit.

- The DOU had three COVID-19 positive patients in Rooms 136 A, 137, and 155 A; and two PUI patients in Rooms 114 A and 156 A.

- The Pediatric ICU had one COVID-19 positive patient and the Pediatric floor had one patient in Room 147 A.

- The Telemetry unit had nine COVID-19 positive patients from Rooms 223 B, 225 A, 226 A, 227 A, 231 A, 234 A, 201A, 202A, and 203A.

- The Medical Pulmonary unit had three COVID-19 positive patients in Rooms 296 A/B, 294 B and 292 B; and PUI patient in Room 286 A.

- The designated COVID-19 unit located on the Telemetry/Med/Surg in the East Tower had 27 COVID-19 positive patients (Rooms 306 A, 308 A,314 A/B, 316 A/B, 318 A, 320 A, 322 A/B, 324 A, 340 A, 342 A/B, 344 A/B, 346 A/B, 348 A, 352 A/B, 354 A, 356 A/B, 358, 360 B, and 362 A). The remaining rooms were non COVID-19 patients.

- The Oncology unit with immunocompromised patients due to chemotherapy had one PUI in Room 412 A.

- The OB/GYN unit also had one COVID-19 positive patient during the initial tour on 7/14/20.

* The hospital failed to provide the dedicated nursing staff to the COVID-19 positive patients. Cross reference to A 397.

Further review of the hospital's timeline showed the following:

Ongoing activity: Daily, weekly, and monthly updates provided to the GB and MEC regarding the COVID-19 statistics, PPE availability, and the testing. However, the timeline including the QAPI data, trends, and graphs on 7/20/20, failed to show the monitoring of COVID-19 patients room placement, physically separated from the non-COVID-19 patients, and assigned to the dedicated staff as per the hospital's P&P.

On 7/16/20 at 1115 hours, the hospital's Administration was informed of the identified concerns related to the COVID-19 positive patient rooms were scattered through out the units and no dedicated staff only assigned to the COVID-19 positive patients.

On 7/20/20 at 1100 hours, during the QAPI meeting with the hospital's administration staff, the CNO presented to the survey team the hospital's plan to cohort the COVID-19 positive patients with the assigned dedicated staff for the hospital's immediate implementation.

2. One of the complaints under grievance was reviewed on 7/20/20, showed the Radiology Transporter tested positive for COVID-19 and was admitted to the hospital. During an interview with the Manager of Infection Control, Director of Radiology, and Manager of Employee Health Director showed the Radiology Transporter did report to the management that he was exposed to the family member who was tested positive with COVID-19, and was on quarantine at home.

Per the Director of Radiology, the Radiology Transporter being asymptomatic was allowed to work as per the hospital's P&P and was mandated to wear a mask. The next few days, the Radiology Transporter admitted to five co-workers that he had coughing and sore throat but did not notify the management of having symptoms.

In a concurrent interview with the Manager of Employee Health, he stated, "The employee must have lied through the hospital screening process. Symptoms of cough and sore throat were part of routine questions in the screening process." The Manager of Employee Health stated the five co-workers were interviewed and stated the Radiology Transporter "takes his mask off to allow him to cough better." The five co-workers were then sent home for quarantine.

When the Manager of Infection Control was asked why the five co-workers failed to report the Radiology Transporter was having symptoms, she acknowledged that despite the inservice education provided regarding COVID-19 infection prevention and the availability of online reporting, there was a need to follow-up and remind current staff.


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3.a. On 7/15/20 at 0922 hours, observation of the Oncology unit was conducted with the Patient Safety Officer and the Manager of Infection Control. Room 456 was observed to have an isolation signage outside of the door. However, the List of Personnel Entering High Consequence Infectious Disease (HCID) Patient Room log was not posted outside the patient's door. The Manager of Infection Control verified that there was no log available at the time.

On 7/15/20 at 0920 hours, an interview was conducted with RN 3. RN 3 stated Patient 8 had an order dated 7/12/20 at 1636 hours, for isolation due to PUI. RN 2 verified Patient 8 was remained on isolation because there was no order to discontinue the isolation from the physician.

On 7/15/20, Patient 8's medical record review was initiated. Patient 8 was admitted to the acute care hospital on 7/12/20.

* On 7/15/20 at 0940 hours, tour of the Medical Surgical of the East Tower was conducted with the Patient Safety Officer and the Manager of Infection Control. Room 310 was a negative pressure and isolation room for Patient 9. There was no HCID log outside the patient's room door. The Manager of Med/Surg Pulmonary reviewed the patient's medical record and hospital binder, and verified there was no HCID log for Patient 9.

On 7/15/20, Patient 9's medical record review was initiated. Patient 9 was admitted to the acute care hospital on 7/14/20. The medical record showed the patient was tested for COVID-19 and the result was still pending.

* In addition, during the tour of the unit, the HCID log for Room 312 showed the last entry dated 7/12/20. The Manager of Med/Surg Pulmonary stated the HCID log was belonged to another patient who was moved to Room 346.

* Review of the List of Personnel Entering High Consequence Infectious Disease (HCID) Patient Room log forms dated 3/27 and 6/4/20, showed the following information to be completed:

- For 3/27/20 version, there were sections for the date, full name (staff), role/department, total time in the room (example 2 minutes), and PPE worn.

- For the 6/4/20 version, there were sections for the date, full name, role/department, total time in room if greater than 15 minutes (yes or no), PPE worn, aerosol generating procedure (yes or no), and patient mask (yes or no).

On 7/21/20 at 0900 hours, an interview was conducted with the Manager of Infection Control. The Manager of Infection Control was asked for the hospital's P&P regarding the use of the List of Personnel Entering High Consequence Infectious Disease (HCID) Patient Room log posting outside of the patients' rooms. The Manager of Infection Control stated the hospital did not have a P&P related to the use of the log and they just used it as a resource tool for the surveillance log. She stated the leadership used the tool in addition to the medical record review and interview with staff for infection control surveillance. When asked if the staff were inserviced with the use of the log, she stated yes and as well as the managers of the units. The Manager of the Infection Control verified the two version of the surveillance log were used on the units.



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b. On 7/14/20 at 1100 hour, a tour of the 2nd floor Tower Medical Pulmonary floor was conducted with the RN Manager 2-3 East Tower.

An observation of Room 260 showed the RT came out of the room. Posting on the room door was a sign-in list that showed no RT's name whom just came out of the room.

On 7/14/20 at 1100 hours, an interview with the RN Manager of 2/3 East Tower was conducted. The RN Manager 2-3 East Tower stated the sign-in sheet (log) posted on the door was for the hospital's infection control to do contact tracing. The RN Manager 2-3 East Tower verified the RT failed to sign the log.

On 7/14/20 at 1500 hours, an interview with the Manager of Infection Control was conducted. The Manager of Infection Control stated the hospital did not have a P&P for the surveillance sign-in log for the patient rooms. The Manager of Infection Control stated all staff have been inserviced about the log. She stated it was a tool she started to track staff that could be exposed to the COVID-19 positive patients for infection control purposes.


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c. On 7/15/2020 at 0935 hour, during the tour in the MICU with the Director of ICU/DOU, it was observed that MICU #16 was the COVID-19 positive isolation room. Patient 16 was observed in bed with nasal oxygen cannula, not masked. Review of the posted "List of Personnel Entering High Consequence Infectious Disease (HCID) Patient Room" showed the patient had a mask on when Cardiology Tech 1 was scanning the patient. The scan was done at the right side of neck. However, during a concurrent interview with Cardiology Tech 1, she stated the patient's scan was for the right carotid (neck) and she did not put a mask on the patient. She stated she was not sure if the patient had a mask because the room was dark. She could not explain the reason why she documented the patient has a mask. Further interview was conducted with RN Q. RN Q stated the patient did not need to have the mask while in the room but should have the mask on when the visitor was in the room.

d. On 7/15/2020 at 1200 hours, the Director of Quality provided Patient 14's List of Personnel Entering High Consequence Infectious Disease (HCID) Patient Room for review. The log showed the following:

- There was a lab person entered the room on "7/16," which would be a future date.
- The log did not have a column to document "patient masked yes/no."

During the concurrent interview with the Director of Quality, he stated the lab person documented the date which was for "tomorrow," instead of 7/15/20. The log was the old version "V 1.4, dated 3/27/2020" which had no space for documenting the masks.

e. On 7/15/2020 at 1000 hours, during the tour with the Director of ICU/DOU in the Pediatric Unit. Patient 13 was a COVID positive patient. The log used was the V. 1.4 , 3/27/2020 for documenting the personal entering for care. There was no availability to document if the patient has mask "yes/no."

On 7/15/2020 at 0930 hours, the Manager of Infection Control reviewed the above findings of the wrong date, not accurate information, and inconsistently version of log used on the floors/units. The Manager of Infection Control explained the log, List of Personnel Entering High Consequence Infectious Disease (HCID) Patient Room, was used to monitor and collect PPE data for trending the staff for properly use of PPE in the patient either with COVID-19 positive and PUI. The data could be used for investigation of employee exposure to the COVID-19 patients. The log V 1.4 3/27/2020 should have been discontinue and replaced by the new log V 1.6 6/4/2020, as per the CDC's guidelines. The hospital staff were trained and informed of the update log. Each unit Director and Manager were responsible to use the correct form.

4. On 7/14/2020 at 1225 hours, Phlebotomist 1 was observed obtaining a blood samples for Patient 14 in the PICU. Patient 14 was an adult COVID-19 positive patient and was not wearing a mask in the room. Phlebotomist 1 donned PPE and N 95 respirator, went into the room, explained the procedure, obtained the blood, and exited the room. The patient did not wear or was told to wear a face mask during the blood drawing procedure.

In addition, while in the patient's room, the phlebotomist was observed touching the patient's bed rails, side table, and items on the table. There was no high touch surface disinfecting observed after the blood drawn by staff.

5. On 7/14/2020 at 1225 hours, during the tour in the PICU with the Director of ICU/DOU, the PICU was observed to have eight private rooms (Rooms 1 to 8) and one shared room for three beds (Beds 9, 10, and 11). The white privacy screen was observed in the hallway. The Director of ICU/DOU stated during the COVID-19 surge, the hospital flexed to use the PICU for the adult patients from the MICU and DOU. The unit divided the pediatrics and adult patients by the privacy screen. Phlebotomist 1 was observed walking toward the PICU side, pushing the privacy screen open, and looking for the adult patient. He was advised by the PICU staff that he was on the wrong side.

* On 7/17/2020 at 0758 hours, the PICU was visited with the Manager Quality. The board with the unit census showed two pediatric COVID-19 negative patients in Rooms 2 and 4. In Room 6 was the adult COVID positive MICU patient. The privacy screen was not in place to separate the pediatric COVID-19 negative and MICU COVID-19 positive adult patients. A concurrent interview with RN K (PICU nurse) was conducted. RN K stated she did not see the privacy screen there when her shift was started. The findings were confirmed with the Manager of Quality.

6. On 7/14/2020 at 1230 hours, a tour in the PICU was conducted with the Director of ICU/ DOU. The PICU had one room occupied with the COVID-19 positive patient. The yellow protective gown was observed being placed on top of the linen cart. During an interview, the Interim Manager of DOU/ICU stated the gown should be hanged up for reuse or discard in trash.

7. Review of the hospital's COVID-19 actions timeline on 7/20/20, showed the following:

- On 7/7/20, the chairs were removed from the staff breakrooms and tents erected outside for breaks.
- On 7/10/20, the Oncology visitor and DOU visitor waiting rooms were arranged as the additional break areas for the employees.

* However, initial tour of the Medical Pulmonary and Telemetry/Med Surg, the main COVID-19 units on the East Tower which had COVID-19, PUIs, and non-COVID-19 patients showed the staff caring for the COVID-19 and non-COVID-19 patients shared the same breakroom and restroom increasing the potential for cross-contamination.

* On 7/14/2020 at 1255 hours, during the tour in the MICU, RN I stated the ICU breakroom was used for all ICU staff. There was no designated breakroom for the RNs who assigned to the PUI and COVID-19 positive patients.

* On 7/15/2020 at 0900 hours, during an interview, the Director Rehab/Bariatrics stated the PTs' assignment was based on the daily patient needs. There was no designated breakroom for the PTs who cared for the COVID-19 positive and PUI patients.

* On 7/15/2020 at 0928 hours, during an interview with RT 1 in the MICU, RT 1 stated the RT's assignment was based on the POINT system, not COVID-19 positive or negative status. The RTs provided care for COVID-19 positive, PUI, and COVID-19 negative patients. RT 1 acknowledged that there was no designated breakroom for the RTs who were assigned to the COVID-19 positive patients and/or non-COVID patients.

* On 7/17/2020 at 0758 hours, a tour in the PICU was conducted. The census board showed two non-COVID-19 PICU patients, one DOU COVID-19 negative patient and one MICU COVID positive patient. The concurrent interview with RN K, she stated she was not aware of the designated breakroom for the RN who had COVID-19 positive patient assignment. They all shared the same restroom.

8. On 7/14/2020 at 1225 hours, during the tour in the PICU with the Director of ICU/ DOU, one physician was observed walking out of the multiple patient room after visiting the MICU patient. The physician was observed leaving the patient care area, touching the personal ID badge and exit door; however, the physician did not perform a hand hygiene. The Director of ICU/DOU confirmed the finding.

* On 7/17/2020 at 0758 hours, during the tour in the PICU with the Manager of Quality. One physician was observed leaving the PICU after visiting the MICU adult patient. The physician was then observed walking into the Pediatric Unit hallway, scanning his ID badge, and pushing the exit door bar. There was no hand hygiene performed by the physician. The Manager of Quality confirmed the observation.