HospitalInspections.org

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Based on interview, record review, and review of hospital policies and procedures, the hospital failed to protect and promote patient rights.

Failure to protect and promote each patient's rights risks physical and psychological harm, and the patient's loss of personal freedom, privacy, and dignity.

Findings:

1. Failure to ensure timely response to patient grievances.

Cross-reference A0122

2. Failure to utilize the least restrictive alternative when using seclusion and restraints.

3. Failure to ensure accurate and complete orders for restraints and seclusion.

Cross-reference A0168

4. Failure to ensure completion of a one-hour face-to-face assessment for patients in violent restraints and to ensure that nurses completing a one-hour face-to-face assessment had specialized training.

Cross-reference A0179


Due to the scope and severity of deficiencies under 42 CFR 482.13, the Condition of Participation for Patient Rights was NOT MET.

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Based on interview, document review, and review of policies and procedures, the hospital failed to complete and send written communication to the complainant within stated time frames for 3 of 5 grievances reviewed (Patient #1601, #1602, #1603).

Failure to meet complaint response times is a violation of the patient's right to a timely response to concerns.

Findings included:

1. Review of the hospital policy titled, "Complaint Management (Patient Grievance Policy)," 320.00 # 7901790, revised 06/20, showed that the Patient Advocate is to forward the investigation to the appropriate clinical leader and if additional time is needed to complete the investigation, the Patient Advocate will provide a written letter to the patient notifying them of the need to extend the resolution timeframe from 7 business days to up to 30 business days,

2. On 10/04/22, Patient #1601 filed a grievance regarding delays in Emergency Department (ED) care. The Patient Advocate acknowledged receipt on 10/04/22 and forwarded the grievance to ED management for investigation. Review on 10/31/22 showed no evidence of further action and no evidence that the Patient Advocate sent a written letter to the patient notifying them of the need to extend the resolution timeframe from 7 business days to up to 30 business days.

3. On 10/14/22, Patient #1602 filed a grievance regarding delays in ED care. The Patient Advocate acknowledged receipt on 10/17/22 and forwarded the grievance to ED management for investigation. Review on 10/31/22 showed no evidence of further action and no evidence that the Patient Advocate sent a written letter to the patient notifying them of the need to extend the resolution timeframe from 7 business days to up to 30 business days.

4. On 10/17/22, Patient #1603 filed a grievance regarding delays in ED care. The Patient Advocate acknowledged receipt on 10/17/22 and forwarded the grievance to ED management for investigation. Review on 10/31/22 showed no evidence of further action and no evidence that the Patient Advocate sent a written letter to the patient notifying them of the need to extend the timeframe from 7 business days to up to 30 business days.

5. On 10/31/22 at 2:16 PM, Investigator #16 interviewed the Patient Experience Program Manager (Staff #1639). Staff #1639 confirmed that no further response had been sent to Patient #1-3, and showed that within 72 hours of receipt, grievances are forwarded to department managers for investigation, with the expectation that investigations will be completed in time to either comply with a seven day response time, or the manager communicate the need for an extension. Staff #1639 stated that because the Patient Relations Specialist (formerly the Patient Advocate)position was vacant as of 10/28/22, followup likely did not occur.

6. On 10/31/22 at 3:00 PM, Investigator #16 interviewed the Interim ED Manager (Staff #1604). Staff #1604 stated that they were aware of the required response times for grievances. Staff #1604 also stated that they were the sole ED leader, and they had prioritized staffing and patient care over grievance responses.

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Based on interview, document review, and review of hospital policies and procedures, the hospital failed to ensure that each order for restraint included the type of restraint to be used (Item 1), and that less restrictive alternatives were attempted prior to the use of restraints or seclusion (Item 2) for 4 of 4 patient records reviewed (Patient #1601, #1602, #1603,
#1604).

Failure to specify the type of restraint to be used and to attempt the least restrictive alternative is a violation of patient rights, and places patients at risk for physical and psychological harm, loss of personal freedom, and death.


Item 1 Provider orders

Findings included:

1. Document review of the hospital policy titled, Restraint and Seclusion Policy," #9004146, revised 02/21, showed that restraint and seclusion require an order from a physician or licensed practitioner (LP). The order must include the type, reason, and duration.

2. Review of Patients #1601, #1602, #1603, and #1604 medical records for use of violent or self-destructive restraints, showed provider orders written that did not specify what type of restraint should be used.

3. On 10/21/22 at 12:35 PM, an interview with the Interim Emergency Department Manager (Staff #1604) confirmed that the orders did not specify limb or body restraints or seclusion. and showed that the electronic medical record did not have the capacity for providers to specify limb restraints or seclusion.

Item 2 Least restrictive alternative

Findings included:

1. Document review of the hospital policy titled, Restraint and Seclusion Policy", #9004146, revised 02/21, showed that the hospital uses the least restrictive form of restraint or seclusion that protects the physical safety of the patient, staff, or others.

2. Review of Patients #1601,#1602, #1603, and #1604 medical records showed no documentation of less restrictive alternatives attempted prior to restraint application.

3. On 10/21/22 at 12:35 PM, an interview with the Interim Emergency Department Manager (Staff #4) confirmed the above findings.

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Based on interview, record review, and review of hospital policies and procedures, the hospital failed to ensure that a licensed provider or specially trained registered nurse completed a one-hour face to face assessment for patients who were placed in violent or self-destructive restraints or seclusion for 4 of 4 records reviewed (Patients #1601, #1602, #1603, and #1604).

Failure to complete a one-hour face to face assessment places patients at risk for physical and psychological harm, and death, and is a violation of patient rights.

Findings included:

1. Document review of the hospital policy titled, Restraint and Seclusion Policy," #9004146, revised 02/21, showed that a Provider (or delegate) will perform a face to face evaluation within one hour and that a registered nurse (RN) is to document "yes" for provider in person evaluation, or "no" for non-provider delegate with appropriate documentation in "comment" section, and RNs will be specifically trained for initiation of violent or self-destructive restraints, provider contact and documentation, and they (RNs) will be trained in the one hour face to face comprehensive assessment.

2. Review of Patients #1601, #1602, #1603, and #1604 medical records showed no documentation of a one-hour face-to face-assessment by a licensed provider.

3. On 10/21/22 at 12:35 PM, Investigator #16 interviewed the Interim Emergency Department Manager (Staff #1604). Staff #1604 confirmed the above findings, and stated that no specialized training regarding the required one-hour face-to-face assessment had been provided to any Emergency Department RNs.

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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 (QAPI) plan to monitor, evaluate, and improve the quality of patient care services through systematic data collection, analysis, and implementation and monitoring of quality activities.

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 and document review showed the following:

1. Failure to systematically collect, aggregate, and analyze quality indicator data as part of the hospital's overall quality program as defined in its policy and procedure.

Cross Reference A-0273

2. Failure to develop action plans when performance goals are not being met.

Cross Reference: A-0283

3. Failure of executive leadership to address priorities for improved quality of care and patient safety and that all improvement activities are evaluated.

Cross Reference: A-0309


Due to the scope of the deficiencies cited under 42 CFR 482.21; the Condition of Participation for Quality was NOT MET.
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Based on interview, and review of the hospital's quality program and quality documentation, the hospital failed to systematically collect, aggregate, and analyze quality indicator data as part of the hospital's overall quality program as defined in its policy and procedure.

Failure to collect, aggregate and analyze data to improve patient outcomes puts patients at risk of substandard care.

Findings included:

1. Review of the hospital document titled, "St. Michael Medical Center Virginia Mason Franciscan Health Facility-Specific Quality Assessment Performance Improvement (QAPI) Plan," number 10333902, revised 08/21, showed that the objectives of the plan included to establish a sustainable and effective culture of safety through continuous assessment and improvement activities, to measure, analyze, and track quality indicators.
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The QAPI plan addresses the full range of services offered by SMMC, including contracted services.
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2. On 10/18/22, Investigator #13 reviewed the Safety, Quality & Improvement Committee (SQIC) meeting minutes for 2022, January through August. The review showed no evidence in the meeting minutes that the hospital reviewed aggregated data, developed process improvement plans, or reassessed effectiveness of interventions for contracted services as identified in the hospital's Quality Plan.

3. Review of the hospital's document titled, "Safety, Quality & Improvement Committee (SQIC), no number or date, showed the schedule for committee reporting, and that contracted services were not scheduled to report.

4. Review of the hospital's document titled, "Hospital Operations Calendar," no number or date, showed the schedule for committee reporting, and that contracted services were not scheduled to report.

5. Review of the SQIC meeting minutes dated May 2022, showed data related to ED throughput were included in the annual ED report. There were no Plan, Do, Check, Adjust (PDCA) processes identified to improve throughput data that were identified in red (26 of 36 items below threshold) in the data tables for the first 4 months of 2022. Time for arrival to being seen by a provider goal was 20 minutes. January was 39 minutes, Febuary was 26 minutes, March was 39 minutes and April was 36 minutes. Disposition decision to discharge goal was 30 minutes. January and February were 48 minutes. March was 49 minutes, and April was 40 minutes. Length of stay for admitted patient goal was 200 minutes. January was 1218 minutes, February was 1114 minutes, March was 822 minutes, and April was 647 minutes. Percent of patients that leave before being seen by a provider goal was 2%. January was 3.6%, March was 2.3% and April was 2.9%. There were 42 of 54 data points identified as red in the 6 months of data reported for 2021. There was no evidence that the throughput data had undergone analysis.
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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. Review of the hospital document titled, "St. Michael Medical Center Virginia Mason Franciscan Health Facility-Specific Quality Assessment Performance Improvement (QAPI) Plan," number 10333902, revised 08/21, showed that the QAPI Plan provides a framework for an integrated and comprehensive program to monitor, assess, and improve the quality and safety of patient care. Objectives of the plan included to establish a sustainable and effective culture of safety through continuous assessment and improvement activities, to measure, analyze, and track quality indicators that assess processes of care, hospital service and operations, adverse events, and quality outcomes, and to set priorities for performance improvement activities based on performance of quality indicators and measure success.
Appendix A describes information flows relating to the QAPI Plan objectives. The QAPI design and scope are further defined in more detail in the following materials. These materials and other supporting details will be made available to surveyors as evidence for review:

a. Charter, reporting schedule and minutes from St. Michael Safety & Quality Improvement Committee (SQIC)

b. CommonSpirit Quality, Safety and Patient Experience Dashboard

c. Data available upon request in the form of minutes, dashboards, and action plans

2. On 10/28/22 at 1:00 PM, during an interview with investigator #13, the Risk Manager (Staff #12) stated that near miss events and serious safety events are reported monthly to executive leadership, and quarterly to the Hospital Operations Committee and SQIC. When asked about incident reports during the recent 10 day downtime, Staff #12 stated that the number of reports was down significantly. There was a paper downtime form that was to be used, but they were not yet entered into the electronic system.

3. On 10/18/22 at 10:05 AM, during an interview with investigator #13, the Quality Manager, (Staff #7), stated that the incident reports that were generated during the downtime were off site. When the investigator requested that the paper documents be brought or scanned and sent for review, Staff #7 stated that the request was not part of the workflow to release incident reports and that the incident reports were not available to the investigators.

4. On 10/19/22 at 10:20 AM, during an interview with investigator #13, the Interim Manager for the Emergency Department (Staff #4) stated that there are no current quality indicators or performance improvement projects related to emergency department throughput, staffing, patient harm or errors.

5. Review of the SQIC meeting minutes dated May 2022, showed data related to ED throughput were included in the annual ED report. There were no Plan, Do, Check, Adjust (PDCA) processes identified to improve throughput data that were identified in red (26 of 36 items below threshold) in the data tables for the first 4 months of 2022. Time for arrival to being seen by a provider goal was 20 minutes. January was 39 minutes, February was 26 minutes, March was 39 minutes and April was 36 minutes. Disposition decision to discharge goal was 30 minutes. January and February were 48 minutes. March was 49 minutes, and April was 40 minutes. Length of stay for admitted patient goal was 200 minutes. January was 1218 minutes, February was 1114 minutes, March was 822 minutes, and April was 647 minutes. Percent of patients that leave before being seen by a provider goal was 2%. January was 3.6%, March was 2.3% and April was 2.9%. There were 42 of 54 data points identified as red in the 6 months of data reported for 2021.The report did not include PDCA process related to analysis of the throughput data or correlation with the staffing crisis or inclusion of any actions taken to improve ED throughput or ED staffing. The minutes showed that the report was for information only, no action required.

6. On 10/18/22 at 1:05 PM, during an interview with the investigator, the Quality Manager (Staff #7) stated that there was no master spreadsheet for the hospital that showed all indicators, prioritization, and monthly monitoring results. Staff #7 stated that they do not receive monthly data from the hospital departments or committees. There are assigned indicator owners that monitor the ongoing data collection. When indicators fall below threshold and necessitate a focused process improvement plan, the indicator owners are responsible for that. There was no standardized process for the number of months below threshold that would trigger a performance improvement project. The Quality Manager would not know that a performance improvement project was needed, or in process, unless the indicator owner reported it at either the Hospital Operations Committee, or the SQIC meeting.
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Based on interview and review of the hospital's performance improvement plan, the hospital's Governing Body and Administrative Officials failed to provide oversight to ensure full implementation of the quality assessment and performance improvement (QAPI) plan.

Failure to provide oversight of the Quality Assessment and Performance Improvement program to ensure full implementation of the Performance Improvement Plan limited the hospital's ability to identify systemic problems and develop action plans to improve patient care and ensure safety.

Findings included:

1. Review of the hospital document titled, "St. Michael Medical Center Virginia Mason Franciscan Health Facility-Specific Quality Assessment Performance Improvement (QAPI) Plan," number 10333902, revised 08/21, showed that VMFH Board and senior leaders determine the type, frequency, and detail of quality and safety data collection. Beyond national and divisional level priorities, measurement and improvement work at the facility level is prioritized by considering the most important patient care needs and essential system functions and processes.

Ultimate accountability for quality management and continuous improvement is with the VMFH Board which has delegated authority for oversight and accountability to the VMFH Board of Directors Quality, Safety, and Patient Experience Committee. The executive team meets these responsibilities by conducting periodic reviews of performance improvement PDCA projects to monitor progress, assist in overcoming barriers, and evaluate outcome, and review follow-up data to determine the sustainability of improvement efforts.

2. On 10/18/22 at 1:05 PM, during an interview with investigator #13, the Quality Manager (Staff #7) stated that there was no master spreadsheet for the hospital that showed all indicators, prioritization, and monthly monitoring results. Staff #7 stated that they do not receive monthly data from the hospital departments or committees. There are assigned indicator owners that monitor the ongoing data collection. When indicators fall below threshold and necessitate a focused process improvement plan, the indicator owners are responsible for that. There was no standardized process for the number of months below threshold that would trigger a performance improvement project. The Quality Manager would not know that a performance improvement project was needed, or in process, unless the indicator owner reported it at either the Hospital Operations Committee, or the SQIC meeting. There would be no report about failure to meet thresholds to the Governing Board unless the information was brought to the SQIC meeting.

3. On 10/31/22 at 11:30 AM, the investigators conducted a Zoom conference call with the Virginia Mason Franciscan Health Governing Board.

Staff #36 stated that reports come up to the Board committee (SQIC) from various other committees. Serious safety events may come directly to the board for review.
Staff #37 stated that the Board has gotten updates regularly about the suicide prevention performance improvement initiative. The board does look at individual indicators at the board level through the quality committee of the board (SQIC).

The ED annual report in the May 2020 SQIC meeting minutes showed that the top 2 items were to stabilize ED Leadership and ED Staff. There were no action items included. The ED throughput data was below threshold for most of the data points, throughout the 12 month reporting period. There were no action items or follow up included in the report. Staff #37 stated that the board received reports regarding workforce and staffing that included nurse sensitive indicators. Human Resources reports turnover, engagement, and recruitment for the hospital.

Staff #36 stated medical staff leaders speak to any specific issues or items covered in their medical staff meetings. If the board members have any questions, they ask them at the time of the medical staff report. The discussions are not included in the minutes.
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Based on interview, record review, document review, and review of the hospital's policies and procedures, the hospital failed to ensure adequate and qualified staff for the provision of emergency care.

Failure to provide adequate and qualified staff for the delivery of emergency care places patients at risk for unsafe, incompetent, and poor quality emergency care.

Findings included:

1. Failure to provide adequate and qualified staff to provide emergent care for 3 of 3 patient records reviewed.

2. Failure to define standards integrating patients' Emergency Severity Index (ESI) and assessment and reassessment policies.

3. Failure to define and validate the job description and competencies for non- employee Emergency Medical Technicians providing oversight of patients in the Emergency Department.

Cross-reference A 1112

Due to the scope and severity of deficiencies cited under 42 CFR 482.55, the Condition of Participation for Emergency Services WAS NOT MET.

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Based on record review, document review, and interview, the hospital failed to define and ensure a standardized process to provide adequate personnel and timely assessments and reassessments to meet the needs of 3 of 3 patient presenting for emergency care (Patient #1605, #1606, #1607).

Failure to ensure a standardized process to provide adequate personnel, and timely assessments and reassessments is unsafe and places patients at risk for poor outcomes and death.

Findings included:

1. On 11/03/22 at 8:00 AM, Investigator #16 interviewed the Interim ED Manager (Staff #1604). Staff #1604 stated that the preferred nurse to ED patient ratio is 1 RN for every 4 ED patients, adjusted as needed for patient acuity, and that the preferred "boarder" (patients remaining in the ED while awaiting bed placement) nurse to patient ratio was 1 boarder nurse to every 5 boarder patients. Staff #1604 also stated that if available, RNs from the various hospital floors were sent to care for boarder patients, but that if boarder nurses were not available, the ED RNs cared for the boarder patients. Staff #1604 stated that there was not a process in place that focused on expediting transfer of boarder patients out of the ED and to the appropriate hospital unit.

Patient #1605

2. Review of the hospital policy titled, "Emergency Department Code Neuro Response Procedure," #11141838, revised 02/22, showed that, based on the triage assessment using a FAST (Face Arms Speech Time) rapid exam for stroke symptoms, activation of a Code Neuro or Extended Code Neuro should occur, and that door (patient arrival time) to provider assessment time should be less than or equal to 10 minutes.

3. Review of the Charge Nurse Shift Report for 09/21/22, 7:00 PM- 7:00 AM, showed an Emergency Department (ED) census of 72 Patients with 42 ED Patients and 30 boarder patients At 11:00 PM, the ED was short 4 ED Nurses, leaving 12 nurses to care for 72 patients, an approximate ratio of 1 RN for every 6 patients, not counting patients waiting in the lobby or any new patients presenting for emergency treatment.

4. On 09/21/22 at 10:20 PM, Patient #1605, a 76 year-old-male, presented to the ED from an urgent care facility, to be evaluated for a possible stroke. Patient #1605 had twice experienced confusion and nonsensical speech earlier in the day.

5. Review of the medical record showed that the triage nurse (Staff #1641) performed a FAST (Face Arms Speech Time) rapid exam for stroke symptoms, which was negative. Patient #1605 was assigned an ESI (Emergency Severity Index) of 2 (emergent) and directed to wait in the lobby. No reassessment of Patient #1605 was documented during the 8 hours and 38 minutes that Patient #1605 waited in the lobby.

6. Review of the ED timeline in the electronic medical record (EMR) and a physician note dated 09/22/22, showed that Patient #1605 was evaluated by a physician at 6:51 AM, 8 hours and 38 minutes after arrival.

7. On 11/08/22 at 9:30 AM, Investigator #16 interviewed Patient #1605's triage RN (Staff #1641). Staff #1641 stated that Staff #1641 was aware of a process to follow for patients presenting with stroke like symptoms, but that Staff #1641's understanding was that a Code Neuro couldn't be called unless the patient had a positive FAST exam. Staff #1641 further stated that during Staff #1641's triage shift, the lobby was full of patients, and because of the number of patients waiting to be triaged, there was not time for any patient reassessment. Staff #1641 also stated that Staff #1641's practice was to notify the charge nurse when the lobby was overwhelmed with patients waiting for triage and treatment, but that there was often no one available to help. Staff #1641 was not aware of any parameters defining the reassessment of patients waiting for treatment.

Patient #1606

8. Review of the Charge Nurse Shift report on 09/26/22 at 7:00 PM, showed 81 ED patients and 36 boarder patients, 6 of 19 ED RNs short, and 5 of 6 boarder nurses short, leaving 14 nurses to care for 117 patients, an approximate ratio of 1 RN for every 8 patients, not counting patients waiting in the lobby or any new patients presenting for emergency treatment.

9. On 09/26/22 at 3:07 PM, Patient #1606, an 81 year-old- male, presented to the ED with a chief complaint of a syncopal episode with hypotension earlier in the day.

10. Review of the ED Timeline in the EMR showed that:

a. At 3:21 PM, a brief triage was performed, and an ESI of 2 (emergent) was assigned.

b. At 3:31 PM, Nurse driven protocols of an electrocardiogram (EKG), and a blood test for troponin (measure of potential heart damage) were initiated.

c. At 3:35 PM, a note in the medical record stated that an MD was notified of EKG completion.

d. At 4:14 PM, the blood test for the troponin level showed that Patient #1606's troponin was elevated.

e. At 5:03 PM, Patient #1606 was returned from a triage room to the lobby.

f. At 7:36 PM, EKG findings of sinus rhythm with 1st degree AV block with premature atrial complexes with aberrant conduction, T wave abnormality, consider inferior ischemia and anterolateral ischemia, abnormal EKG were confirmed by a physician.

g. At 7:59 PM, Emergency Department physician evaluation began, 4 hours and 50 minutes after arrival. No documentation of Patient #1606's reassessment was found between 3:07 PM and 7:51 PM. (4 hours 44 minutes).

h. At 10:25 PM results of a Chest Cat Scan (CT) showed that Patient #1606 had a massive saddle pulmonary embolism (blood clot in a crucial lung area).

i. At 10:52 PM, an order was placed for thrombolysis/thrombectomy (attempt to disolve and remove a blood clot) and Patient #1606 was transferred to the Interventional Radiology (IR) suite.

j. On 09/27/22 at 1:05 AM, mid thrombolysis/thrombectomy procedure, Patient #1606 became unresponsive and emergency resuscitation started. Patient #1605 had a return of spontaneous circulation (ROSC) and was transferred to the ICU. During nurse to nurse handoff in the ICU, Patient #1606 was noted to be pulseless and was resuscitated again, with ROSC. Patient #1606 was intermittently unresponsive and resuscitated multiple times between 1:00 AM and 3:00 AM, when resuscitation efforts ceased due to medical futility.

11. On 11/09/22 at 11:30 AM, Investigator #16 interviewed Patient #1606's triage RN (Staff #1641). Staff #1641 stated that she was alone in triage with a full waiting room and that there were so many people waiting for triage that she did not have time to review lab results for patients who had already been triaged, or perform any reassessments, so she was not aware of Patient #1606's elevated troponin level, abnormal EKG, or any possible changes in condition. Staff #1641 also stated that there were no additional RNs available to help with patient triage.

12. On 11/09/22 at 12:00 PM, Invetigator #16 interviewed the 09/26/22-09/27/22 night shift triage RN (Staff #1640), who was taking over for Staff #1641. Staff #1640 stated that the lobby was full, but prior to beginning triage for new patients, she reviewed test results for approximately 25 patients previously triaged by Staff #1641. Staff #1640 noted and reported Patient #1606's elevated troponin to an ED physician, and at 7:53 PM completed a second troponin level and repeated vital signs. The repeat troponin result was also elevated, and Patient #1606 was transferred to ED Room 6.

13. On 11/09/22 at 6:30 PM, Investigator #16 interviewed the Interim ED manager (Staff #1604), Staff #1604 stated that persons triaged as ESI 2 are emergent and should begin receiving evaluation and treatment rapidly.

14.On 11/08/22 at 9:30 AM, Investigator #16 interviewed Patient #1606's ED physician(Staff #1649). Staff #1649 stated that the ED frequently was not fully staffed with RNs. Staff #1649 stated that, based on presentation and history, Patient #1606 may have benefited from a more timely physician evaluation.

Patient #1607

14. Review of the Charge Nurse Shift Report for 10/31/22, 7:00 PM- 7:00 AM, showed an ED census of 73 Patients with 46 ED Patients and 26 admitted patients boarding. At 11:00 PM the ED was short 4 ED Nurses, and 2 Boarder nurses, leaving 12 nurses to care for 73 patients, an approximate ratio of 1 RN for every 6 patients not counting people waiting in the lobby or any new patients seeking treatment.

15. On 10/31/22 at 9:41 PM, Patient #1607, a 90 year-old female, presented to the ED after a fall in her home shower resulted in sharp rib pain and shortness of breath. Patient #7 stated that she thought her ribs were broken.

16. Review of the EMR ED timeline for Patient #1607 showed that:

a. At 10:30 Pt #1607 received a rapid triage assessment and was assigned an ESI of 4 (less-urgent).

b. At 10:59 PM, an ED MD evaluated Patient #1607 while in the lobby, noted L sided rib pain, ordered a chest CT and requested that Patient #1607 be started on oxygen and placed on a cardiac monitor.

c. On 11/01/22 at 12:43 AM, chest CT results showed a left flail chest (one or more ribs broken in two places) with a tiny left hemothorax (blood in lung) and lung laceration.

17. On 11/08/22 at 7:00 AM, Investigator #16 interviewed Patient #7's triage RN (Staff #1642). Staff #1642 stated that at the time of the cardiac monitoring and oxygen administration orders, there was not an ED bed or nurse for the patient and that the lobby did not have the capacity for cardiac monitoring or oxygen delivery.

18. On 11/08/21 at 10:30 AM, an interview with an ED Charge Nurse (Staff #1621), showed that Staff #1621 recalled that Patient #7's ED physician notified Staff #1621 that Patient #1607 needed cardiac monitoring and oxygen approximately 90 minutes after Patient #1607's arrival, but that Staff #1621 had neither a nurse nor a bed in the ED for Patient #1607. Staff #1621 was not able to place Patient #7 in an ED bed with cardiac monitoring, oxygen delivery capacity, and an RN until 1:05 AM on 11/01/22.

19. On 11/08/22 at 7:00 AM, Investigator #16 interviewed Patient #1607's triage RN (Staff #1642). Staff #1642 stated that Staff #1642 performed a rapid triage instead of a full assessment that may have revealed rib bruising or deformity, because placing the patient in a triage room for the more comprehensive exam would have left the lobby unattended by a nurse. Staff #1642 further stated that Staff #1642 assigned Patient #1607, a 90 year -old with sharp rib pain and shortness of breath after a fall, an ESI of 4 (non-urgent) because Staff #1642 thought that Patient #1607 would need just a chest x-ray.

20. On 11/09/22 at 6:30 PM, ,an interview with Interim ED Manager confirmed that in order to reduce the risk of unexpected outcomes, that Patient #1607's age and mechanism of injury alone should have resulted in a minimum ESI score of 3 (urgent).

21. Review of the hospital policy titled, "Nursing Assessment and Documentation- Emergency Department", and "Addendum A:ESI Algorithm-2020 Edition", showed that the policy states that reassessment is ongoing and dependent and driven by patient condition. Parameters for assessment and reassessment are not objectively defined.

22. On 10/20/22 at 11:00 AM, Staff #16 interviewed a group of ED Charge Nurses (Staff # 21-30) regarding the escalation process to be followed when short of nursing staff. Staff #21-30 consistently stated that when short staffed, the process for escalation was to notify the manager, when on duty, or the house supervisor if the manager was not present. If the house supervisor was unable to solve the staffing issue, the house supervisor was to notify the administrator on call. Staff #'s 21-30 stated that the house supervisor response varied depending on the house supervisor, and that additional nursing staff were usually not available.

23. On 10/31/22 at 1:00 PM, Staff #16 interviewed a group of House Supervisors (Staff #43-48). Staff #43-48 stated individual approaches to problem solving as related to ED staffing shortages, including inconsistent escalation through the chain of command to the Administrator on Call (AOC). Staff #43-48 stated that escalation to the AOC was often not productive if the AOC was a non-nursing person such as a Social Work Manager or a Pharmacist, so sometimes the AOC would not be contacted.

24. On 10/20/22 at 11:00 AM, Staff #16 interviewed a group of ED Charge Nurses (Staff # 21-30). Staff #s 21-30 stated that when the triage nurse(s) were overwhelmed in the lobby, without any staff available to assist, the charge nurse could call Olympic Ambulance Service, a private transport company, to send Olympic Ambulance Emergency Medical Technicians (EMTs) to help monitor patients in the lobby. On one occasion, when Olympic Ambulance staff were unavailable, a Charge Nurse called Kitsap Central Fire to request help in monitoring patients waiting for services in the lobby. The Charge Nurses reported that there was not a systematic process for determining when assistance was needed, that they might or might not notify the House Supervisor that Olympic Ambulance personnel were needed, and that sometimes when asked, the house supervisor would call Olympic Ambulance to request assistance.

25. Review of a document titled, "Triage Tracker," dated 07/15/22-10/13/22, showed that the hospital had utilized EMTs to provide monitoring of patients in the lobby for 275.5 hours during that time period.

26. On 10/31/22 at 10:30 AM, Investigator #16 interviewed the Chief Nursing Officer(CNO) (Staff #1603) and the Chief Executive Officer (CEO) (Staff #1601). Staff #1603 and Staff #1601 stated that the hospital accepted Olympic Ambulance's attestation that the EMTs had current credentials and competencies, confirmed that there was no hospital job description detailing the duties and expectations and competencies for EMTs, that the hospital had not assessed the EMTs competency levels, and that the hospital was unaware that the EMTs used in the hospital were practicing out of their scope because the EMT credential was a prehospital credential. Staff #1601 and Staff #1603 also stated that many attempts were being made to mitigate nursing shortages, but confirmed that there was no immediate mitigation process in place to provide adequate nursing staff on a daily basis.

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Based on document review and interview, the hospital failed to ensure that the emergency preparedness policies and procedures aligned with the identified hazard "IT System Failure" within the hospital's risk assessment.

Failure to fully develop policies and procedures based on the risk assessment, risks implementation of processes that are inadequate for the risks at the facility.

Findings included:

1. Document review of the emergency preparedness plan titled, "Emergency Management (Disaster) Plan, 504.00 PolicyStat ID 11971127, last reviewed 08/22, indicated based on the risk identification, mitigation strategies are developed that will eliminate or reduce the probability of a threat posed by a hazard associated with an emergency or disaster. In a long list of emergencies/disaster IT system failure was not identified as a hazard associated with an emergency or disaster. Investigator #1 found a comment under "Utility Failure" which was identified as a hazard associated with an emergency or disaster that stated, "CHI Franciscan in the past 5 years the healthcare system had experienced network and data failure. Investigator #1 looked under utility failure and found on page 20 under, "Alternate Utility Systems for Computer Systems" which indicated to follow the "Downtime procedures that are in place for computer systems."

Review of the hospitals policy titled, "Downtime Policy," Policy Stat #6661706, last reviewed 07/2019, showed that the purpose is to identify the process and procedures to prepare, respond, and recover from a computer downtime event at a CHI Franciscan facility. The policy indicated that actions are taken to reduce the impact of a downtime through (mitigation), preparation for planned events, response during a downtime event, and recovery (clinical and financial data) from a downtime event.

The "Downtime Preparation" policy showed "Planned Downtime Events" that are pre-scheduled, or anticipated downtimes due to system upgrades or "fixes", will be scheduled at times during non-peak hours. If planned downtime is required during peak hours, it will be conducted at a time that would result in minimal disruption to patient care, examples are during weekend hours or after regular business hours. The policy only provides information on preparation for planned events but not unplanned events.

Invetigator #1 determined that planned events are scheduled during off peak hours, which does not ensure that all shifts are participating in the testing. The only information in the policy regarding unplanned events was found under "Response," This section only indicated how an unplanned event is determined ,who gets notified and how notification is sent. Under mitigation, both planned and unplanned events will have access to specific computers for current information in read only. The policy lacks actionable procedures for a cyber-attack causing a complete outage of all computer systems resulting in prolonged use of paper charting.

2. On 10/21/22 between the hours of 11:30 AM and 1:00 PM, Investigator #1 interviewed the Division Director of Emergency Preparedness Management (Staff #101) about the cyber-attack that occurred 10/02/22 -10/16/22. Investigator #1 reviewed the Hazard Vulnerability Analysis (HVA) with Staff #101. Investigator #1 was unable to identify the word Cyber-Attack on the HVA. Staff #101 pointed to "IT System Failure" and said it was considered an IT System Failure. During review of the HVA, Investigator #1 asked to see the policy and procedures for IT system failure. Staff #101 indicated that staff were to follow the "Downtime" Policy and procedures for all IT system failures.

Staff #101 indicated that the policy, regardless of "planned or unplanned events", specific computers will be functioning that contain current information in read only mode. Staff #101 confirmed that during the cyber-attack staff were unable to access patient records in read only mode..

The policy lacks actionable procedures for staff to follow for a cyber-attack.

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Based on document review and interview, the hospital failed to develop a testing and training program that is reflective of the risks and hazards identified in the hospital's Hazard Vulnerability Analysis specifically for a cyber-attack.

Failure to develop testing and training policy and procedures for a cyber-attack places patients, staff, and visitors at risk from inadequate implementation of the program should it need to be activated.

Findings included:

1. Document review of the emergency preparedness plan titled, "Emergency Management (Disaster) Plan, 504.00," PolicyStat ID #11971127, last reviewed 08/22 showed, that based on the hospital's risk identification and hazard analysis, mitigation strategies are developed that will eliminate or reduce the probability of a threat posed by a hazard associated with an emergency or disaster. The emergencies and disasters that were identified as a potential threat i.e., earthquakes, winter storms etc. did not include, "IT System Failure". The only clue to identify where to find any information on IT System failure was under the disaster/emergency for "Utility Failure" which had a comment that stated, "CHI Franciscan in the past 5 years the healthcare system had experienced network and data failure."

Document review of the section titled, "Utility Failure", under the subsection titled "Alternate Utility Systems for Computer Systems", showed staff should follow the Downtime procedures that are in place for computer system outages.

2. Document review of the policy and procedure titled, "Planned Downtime Events, Policy Stat 6661047, effective date 9/2017, showed, pre-scheduled or anticipated downtimes due to system upgrades or "fixes" these pre-scheduled downtimes will be at times during non-peak hours. If planned downtime is required during peak hours, it will be conducted at a time that would result in minimal disruption to patient care, examples are during weekend hours or after regular business hours. The policy only provides information on preparation for planned events not unplanned events. Review of the policy showed planned events are scheduled during off peak hours this does not ensure that all shifts are participating in the events. Both planned and unplanned events indicate through mitigation that specific computers will be functioning that contain current information in read only. The policy lacked actionable procedures for a cyber-attack that would cause an outage of all computer systems and result in prolonged use of paper charting.

3. Document review of the last 2 exercises titled, "Cascadia Rising 2022 - Catastrophic Earthquake/ Tsunami Response," Exercise Date 06/07/22 thru 06/09/22, and "Radiological Contaminated Injured Person (CIP)," Exercise date 06/30/22, showed both exercises did not incorporate IT system failure/cyber-attack as part of the testing of the exercise. The Cascade Rising 2022 exercise stated that the ED department did not fully participate due to the inability to determine locations for triage and holding areas for minor and delayed patients.

4. Document review of employee staff training by Invetigator #1 showed the following:

a. Cyber-attack training called Enterprise and Vantage Point which consisted of how to recognize and report phishing attempts on emails.

b. The hospital's orientation and annual emergency preparedness online training provided training on emergency response notification systems and staffing models used for standards of care.

Neither training provided information on cyber-attacks in which computers are completely inaccessible.

5. On 10/21/22 between the hours of 11:30 AM and 1:00 PM, Investigator #1 interviewed the Division Director of Emergency Preparedness Management (Staff #101), about the testing and training of the program based on the hospital's risk assessment for IT system failure. The interview showed:

a. Staff #101 indicated that there were plans to do a cyber-attack training in June of this year 2022 but it was cancelled. Staff #101 provided the last 2 exercises, "Cascade Rising 2022" and "Radiological Contaminated Injured Person (CIP)". Neither exercise incorporated testing or staff training for IT system failures.

b. When Investigator #1 asked about employee training, Staff #101 indicated that staff are to follow the hospital policy on "Downtime", for scheduled and unplanned computer events. Notifications are sent to staff and staff are instructed to go to paper charts until computer system upgrades/fixes are completed. When Surveyor #1 asked for a list of who participated in these scheduled events. Staff #101 indicated that these events were not drills or exercises so no documentation on participation was taken.

c. When Investigator #1 asked about unplanned downtime events, Staff #101 provided an example of an IT system failure that occurred in 2021 that lasted up to 4 hours. Staff were notified to follow the "Downtime" procedures. Staff #101 indicated that planned and unplanned events staff still had computer access to patient information in read only mode.

6. On 10/24/22, Investigator #1 interviewed the following staff that indicated that they had not received Cyber Attack training that included what to do when electronic health records were completely inaccessible:

a) At 9:10 AM, an Emergency Department Registered Nurse (Staff #102) stated that they hadreceived downtime training in another CHI Franciscan hospital but was able to access patient records in read only. The training did not include having no computer access to patient health records

b) At 9:40 AM, an Emergency Department Registered Nurse (Staff #103) indicated involvement in previous unplanned downtime IT failure exercises at the current hospital but was able to access patient records in read only. The training did not include cyber-attack training.

c) At 1:36 PM, a Medical Assistant - Phlebotomist (Staff #104) stated that they had no training in cyber-attack training during which computers were inaccessible.

d) At 2:49 PM, a Pharmacy Technician (Staff #105), stated that they had participated in a downtime event that included access to read only information. Staff #105 stated the training did not include a cyber-attack where computers were inaccessible.

e) At 11:25 PM, a Medical Doctor (Staff #106), stated that they had participated in downtime events during which staff had read only access to patient medical records.

f) At 11:25 PM, a Medical Doctor (Staff #107) stated that they had participated in downtime events during which staff had read only access to patient medical records.

g) At 10:07 AM, an Emergency Department Registered Nurse (Staff #108) stated that they had participated in scheduled and unscheduled downtime events but not when the computer was completely inaccessible.