HospitalInspections.org

Based on observations, interviews, review of incident and medical record documentation for 5 of 5 ED patients who experienced SA or SH in the ED (Patients 2, 6, 7, 8, and 9), review of P&Ps, and review of PERA and other documentation, it was determined that the governing body failed to ensure the provision of safe and appropriate care to patients in the hospital in a manner that complied with all Conditions of Participation.

This Condition-level deficiency represents a limited capacity on the part of the hospital to provide safe and adequate care.

Findings include:

1. Refer to the findings cited at Tag A115 under CFR 482.13 - CoP: Patient's Rights.

2. Refer to the findings cited at Tag A263 under CFR 482.21 - CoP: Quality Assessment and Performance Improvement.

3. Refer to the findings cited at Tag A385 under CFR 482.23 - CoP: Nursing Services.

4. Refer to the findings cited at Tag A450 under CFR 482.24(c)(1) - Standard: Content of Record.

5. Refer to the findings cited at Tag A700 under CFR 482.41 - CoP: Physical Environment.

6. Refer to the findings cited at Tag A1100 under CFR 482.55 - CoP: Emergency Services.

Based on observations, interviews, review of incident and medical record documentation for 5 of 5 ED patients who experienced SA or SH in the ED (Patients 2, 6, 7, 8, and 9), review of P&Ps, and review of PERA and other documentation, it was determined that the hospital failed to fully develop and implement P&Ps that ensured each patient's right to receive care in a safe setting. The hospital's failures created an unsafe EOC in the ED that resulted in actual and potential physical, mental or emotional harm to patients. Those failures were related to the EOC and EOC assessment, patient assessment, patient observation, staff situational awareness, and incident investigation.

Those failures resulted in actual harm and subsequent death for Patient 8, and actual and potential harm to other patients. The findings are described in detail under Tag A144, as is the hospital's response to Patient 8's incident.

This Condition-level deficiency represents a limited capacity on the part of the hospital to provide safe and adequate care.

Findings include:

1. Refer to the findings cited at Tags A144 and A145 under CFR 482.13(c) - Standard: Privacy and Safety.

Based on observations, interviews, review of incident and medical record documentation for 3 of 3 ED patients who used cords as ligatures for SA and SH (Patients 6, 7, and 8), review of P&Ps, and review of PERA and other documentation, it was determined that the hospital failed to fully develop and implement P&Ps that ensured each patient's right to receive care in a safe setting. The hospital's failures created an unsafe EOC in the ED that resulted in actual and potential physical, mental or emotional harm to those patients and included:

A. Regarding the EOC:
* There was lack of risk assessment and mitigation related to cords and ligatures in the ED EOC that could be, and were, used for patient SAs and SH. The PERA and the ED MHERA were not complete and did not clearly address the existence of ligatures and ligature points in ED Rooms used for "overflow" BH patients, and the PERA had not been updated at least annually as required by P&P.

B. Regarding physician's orders and patient assessment:
* There was lack of follow-up to ensure timely BH or psychiatric evaluation as ordered.
* There was failure to follow P&Ps related to SR assessment and reassessment, including maintaining SR level as "High" when patients were unable to respond to the SR questions.
* There was lack of ED patient reassessment of SR at least every four hours per P&P, including that reassessments were documented as completed when patients were sleeping.
* There was failure to acknowledge and assess patients' suicidal statements.
* There was lack of clear criteria and documented assessment for changes of SR level from "High" to "Moderate."
* There was lack of evidence of in-person patient assessment by the ED RN for a full shift.

C. Regarding patient observation and other SR precautions:
* There was lack of appropriate observation and monitoring of BH patients identified with SR who were roomed in ED Rooms used for BH "overflow." RVM processes, and RMT practices, in another location and floor of the hospital did not ensure continuous and effective observation.
* Although the PERA reflected numerous risks existed in the ED rooms used for "overflow" BH patients, it clearly indicated that most of those risks were only "partially" mitigated when patients were monitored via continuous RVM or 1:1 direct observation.

D. Regarding lack of staff situational awareness:
* Although PERA reflected that numerous risks in ED "overflow" rooms were only "partially" mitigated when patients were monitored via continuous RVM or 1:1 direct observation, ED staff deferred responsibility for observation of patients with SR to RMT staff on another floor of the hospital, including when ED Room door of a patient with SR was closed.
* ED staff provided socks to a patient with SR without a documented risk assessment.
* Annual staff competencies related to patient SR had not been completed since 2020.

These failures resulted in actual harm and subsequent death for Patient 8, and actual and potential harm to other patients. The findings described under Findings 3.b. and 3.d. that follow reflect that in response to Patient 8's SA, the hospital had mitigated an IJ situation prior to the unannounced SSA complaint survey. On 03/09/2022, the day of Patient 8's SA, the hospital initiated an investigation, the following day on 03/10/2022 RVM was discontinued for patients with SR who were in ED "overflow rooms," and for those patients dedicated 1:1 in-room "Sitters" were initiated to provide continuous observation. The use of dedicated 1:1 in-room "Sitters" for patients with SR or BH concerns who were in ED "overflow" rooms was verified on Day 1 and Day 2 of the SSA complaint survey.

Although the IJ was mitigated the findings reflected that there remained a Condition-level deficiency that represented a limited capacity on the part of the hospital to provide safe and adequate care.

Findings include:

1.a. The P&P titled "Management of the Patient at Risk for Self Injury (Suicide)" dated at "last revised 09/2019" was reviewed. It included the following information and direction:
* "The standardized tool for all screening is the [CSSRS]."
* "All patients presenting to the [ED] with a primary behavioral health chief complaint will receive the [CSSRS] by an RN. This scale will stratify the patient risk into High, Moderate, Low or no current risk categories."
* "The patient who refuses/unable to speak or answer the screening questions, will automatically be considered at 'High Risk.'"
* "A patient who is Moderate or High Risk requires safety checks every four (4) hours as well as a reassessment every day with the [CSSRS] tool."
* "At the time of room assignment, the RN will document the environmental risk assessment, utilizing the [ED MHERA] and implement mitigating strategies as able. RN caring for the patient will continue to document the assessment including the patients [sic] well being at minimum of every four (4) hours."
* "Continuously Monitored - means the patient is being monitored by 360 degree camera visualization and personnel are continually visualizing the monitor. The monitor viewing for the ED will be performed in the ED Crises [sic] Area Office that is adjacent to the ED and staff are immediately available to respond. The personnel will be relieved for lunch and break by another staff member who will provide the continuous monitoring."
* "Continuously Attended - means the patient will be assigned a one-to-one Patient Sitter with a 360 degree view of the patient and room, and immediately available to respond or assure other staff members respond immediately. A patient screened for SI High Risk will have a continuous Patient Sitter with them."
* "High risk patients for suicide shall be monitored by a 1:1 direct observation."
* "Moderate risk patients for suicide shall be continuously monitored via a 360 camera or 1:1 direct observation that is being continuously monitored by a CHI Mercy Health employee."
* "Room Assignment ... In the ED the rooms identified are all of the Crisis Rooms and all other ED exam rooms except #26."
* "Mitigation of Patient Room - Prior to placing the patient in the assigned room the [ED MHERA] ... will be completed. Sharps, glass items, needles, syringes, sharps disposal boxes, medication and unnecessary furniture or equipment shall be removed, locked or secured in accordance with facility approved checklist."
* "For Moderate/High Risk SI patient the 1:1 sitter/remote monitoring staff will document safety checks every 15 minutes on the Sitter Observation Form."
* "The [ED MHERA] and the Sitter Observation form will be scanned into the medical record at time of discharge."
* "'Moderate' and 'High' patient will identify resource supports and develop a plan as outlined on 'My Safety Checklist.' The 'Safety Checklist' will be completed prior to discharge. The discharging RN will review and place copy in patient record for scanning."
* "Staff will complete initial competency for [SR] within 30 days of hire, and then annually. Staff will complete [RVM]/Sitter competency prior to providing that assigned responsibility within the patient units."

The P&P was not followed as reflected in the patient findings that follow in this deficiency. Further, the P&P was not clear or complete. For example:
* It did not reflect when and how patient assessment by QMHPs or qualified LIPs would occur.
* It did not clearly reflect criteria for reduction of SR level from High to Moderate or lower, including who had responsibility and authority to make that decision.
* It was not clear whether every four-hour "safety checks" and CSSRS reassessments were separate processes.
* There was no information related to what the criteria for safe discharge was for patients identified at High or Moderate SR.

1.b. The P&P titled "Video Monitoring of Patients in Crisis Unit" dated as "last revised 09/2018" was reviewed. It included the following direction:
* "All patients in the Crisis Unit Rooms as well as the common hallway will be continuously monitored via video monitoring. Monitoring will be done by Clinical staff or Sitter who have completed [SR] or Sitter Competency."
* "Staff member assigned to watch video monitoring will not be distracted and have no other assigned duties."
* "Overflow Patients requiring direct observation in Main [ED]. After patient room has had environmental risk assessment completed and appropriate mitigation has been completed, patients will be continuously monitored via video monitoring using same process and staff assigned to monitor patients on Crisis Unit."

The P&P was not clear in relation to:
* What the maximum number of patients to be video monitored was in the Crisis Unit and common hallway, and the Main ED overflow.
* How many patients were to be continuously monitored via video by how many staff members in both the Crisis Unit Rooms and common hallway, and Main ED overflow.
* Where the video monitors were located in relation to the Crisis Unit Rooms and common hallway, and Main ED overflow.

1.c. The P&P titled "Remote Sitter Monitoring Guidelines" dated as "last revised 03/2021" was reviewed. It included the following direction:
* "Any patient with a positive [SR] screen or Physical Hold, will be monitored through central camera monitoring."
* "A patient determined to be at risk for suicide shall be continuously monitored by a 360 degree camera that is continuously monitored by a CHI Mercy Health employee, that has been trained and determined to be competent in the Monitoring Role. Monitor Staff must not be distracted by any other activity such as reading, use of phone, etc."
* "The monitor viewing for the ED will be performed in the ED Crisis Area Office that is adjacent to the ED and staff are immediately available to respond, if needed the this [sic] may also be monitored from [RVMS]."
* "Monitoring Sitters will record patient observations of patient activity for Moderate SI and MD Hold Patient, on Sitter [form]. High Risk SI individuals, the [form] will completed by the 1:1 Sitter."
* "Sitters will utilize 'Code Purple' for SI patients who demonstrate activities that are a threat to life. Code Purple will be called to the switch board for announcing over head. Response Team will include: Nursing Staff of unit, Nursing Coordinator, and Security."

The P&P was not followed as reflected in the patient findings below. Further, it did not clearly delineate circumstances, processes, locations, and documentation for monitoring of High SR patients versus Moderate SR patients.

1.d. The undated "Remote Camera Monitoring Staff Manual" was reviewed. It included the following:
* "Remain alert at all times. If you get sleepy, tell your team member immediately."
* "Do not make personal phone calls."
* "Do not leave your patient monitoring assignment until you are relieved by another staff person."
* "The monitoring team is two staff individual(s) with 12 hour shifts. This allows for break and lunch coverage. Call the Nursing Supervisor if you need to leave at any other time and wait until relief person arrives."
* "There may be times when one or both staff may be called upon to sit in a patient's room who is 'High' Risk for suicide."
* "Only one person may sit with a 'High' risk patient if there is a 'Moderate Risk' patient on camera monitoring."

The directions in the manual were not followed as reflected in the patient findings below.

2.a. The ED PERA titled "Annual Ligature and Self-Harm Environmental Risk Assessment Tool" dated 02/14/2020 was reviewed. The completed tool was specific to the regular treatment rooms and areas in the ED and not the rooms in the ED designated as BH "Crisis Unit" rooms. The "Crisis Unit" had a separate PERA. The PERA reflected:
* "To prospectively identify and eliminate environmental risks for patient suicide and suicide attempts in setting designated for treatment of psychiatric patients, including ... non-behavioral health units designated for treatment of psych patients ( [sic] i.e., special rooms/safe rooms in ED ..."
* "Complete this Risk assessment Tool at least annually or when a new area is utilized ..."
* Safety features and items in the ED EOC identified in 22 areas of the 16-page PERA were marked as "PRIOR to Controls implemented ... Not Met." The "Controls Added to Mitigate Risk" for the majority of those was "Patients will be monitored via continuous video monitoring or 1:1 direct observation." For 17 of those 22 sections that were "Not Met" the "Status of Risk Mitigation AFTER Controls Implemented" was documented as "Partially Met." Those included features/items that posed a ligature risk.
* Safety features and items in four areas in the ED EOC were identified as "PRIOR to Controls implemented ... Partially Met." Those included "Cords ... Is the area free of unnecessary cords ... If cords are present they should be 12 inches or less. Cords of any length are not recommended for seclusions rooms." The "Controls Added to Mitigate Risk" reflected "Patients will be monitored via continuous video monitoring or 1:1 direct observation. All cords that can be removed will be (monitor, oxygen, call light, etc.) cords for bedside computer will not be able to be removed." The "Status of Risk Mitigation AFTER Controls Implemented" was recorded as "Partially Met."

The PERA clearly reflected risks were present in the ED for patients with SR and many of those risks could not be fully mitigated.

The next ED "Annual Ligature and Self-Harm Environmental Risk Assessment Tool" completed was dated 03/14/2022, more than two years after the previous assessment, and after the patient incidents described in the findings below.

2.b. The three-page "[MHERA ED] Rooms 1-19, 24 and 25" form with version date "3/18" was reviewed. It reflected its purpose included "To prospectively identify and eliminate environmental risks for [ED] suicide and suicide attempts." The checklist-type form contained a multi-column table with rows for 58 items that may be found in a patient room. The column headings to be addressed for each item were "Potential Risk," "Item Removed," "Increased Staff Awareness," "Increased Patient Visualization," and "Comments/Other."

Although the ED "Annual Ligature and Self-Harm Environmental Risk Assessment Tool" dated 02/14/2020 identified "Cords" as a safety feature that posed safety risk, the only reference to cords and cables or other similar items that might be used to form a ligature on the ED MHERA were: "Phone Cords," "IV ... Tubing," and "Call light." The form did not identify or include other cords and cables such as those used for equipment, electronic, and Internet devices and purposes.

3.a. Review of Patient 8's medical record revealed it included the following information related to their SA incident in ED "overflow" Room 25 that began on 03/08/2022. The record reflected that P&Ps were not followed or documentation was not clear or complete:

* At 1736 on 03/08/2022 an RN documented a triage assessment that reflected "Pt brought in by police after pt had pistol taken away ... Pt told police that [they] would kill [themself] however [they] could. Pt has been of [sic] psych meds X5 days. Pt has been on meth X3 days." The RN documented a CSSRS that reflected:
"1. In the past month, have you wished you were dead or wished you could go to sleep and not wake up? [Yes]
2. In the past month, have you had any actual thoughts of killing yourself? [Yes]
3. In the past month, have you been thinking about how you might do this? [Yes]
4. In the past month, have you had these thoughts and had some intention of acting on them? [Yes]
5. In the past month, have you started to work out or worked out the details of how to kill yourself? Do you intend to carry out this plan? [Yes]
6. In your lifetime, have you every done anything, started to do anything, or prepared to do anything to end your life? [No] ...
Level of Risk\ HIGH
Observation Requirements: High: Constant 1:1 direct line of sight monitoring.
Notify Provider if Moderate/High Risk? [Yes]."

* At 1740 an RN documented patient room change from waiting room to "Room 25 ED."
* At 1745 an RN wrote "Pt to Room 25 following triage with [LEO] Pt is in hand cuffs behind [their] back, Pt is cooperative, Noted that eyes are half dialated [sic]. [LEO] reports that Pt's [friend] called for assistance when Pt had a handgun and stated desire to kill [themself] ... [Patient 8] asks provider if [provider] can just give [them] a lethal dose and let [them] die ..."
* At 1745 an RN wrote "Sitter at door 1:1 for High Risk."
* At 1745 a MHERA was conducted, and the ED MHERA form was completed. Although the form was signed, the date and time it was signed was not recorded.
* At 1750 a physician's order was written for "High Risk Suicide Initiation."
* At 1755 a physician's order was written for "Provider Consult ... [psychiatrist] to Re-Evaluate in Morning."
* At 1831 an RN wrote "Pt has been medicated with oral meds per EMAR, Pt took them cooperatively."
* At 1837 an RN note reflected the patient's response to the question "Do you feel concerned for your safety" was "Yes."
* At 1838 an RN note reflected "Thoughts of Harming Self/Others? [Yes] Do you have a plan? [Yes] Comment: [States they'll] do anything for SI. As long as it works."
* At 1839 an RN note reflected "Initial Risk Identified/High ... 1:1 Observation? [Yes] Time started: 1745."
* At 1842 an RN wrote "Enter room to obtain Covid [test]. Pt [states they're] not feeling safe here. Assure [them] that [they are] safe as long as [they are] here at the ED. [Patient 8] states, 'I'm not safe and I believe you know it too.' Pt refuses Covid [test]."
* At 1903 an RN note reflected Patient 8 "stated 'I don't want to talk to [parent]. I've already said my goodbyes to anyone that counts' ... Sitter continues at doorway for 1:1."

* At 1948 physician's orders reflected the order previously written for "High Risk Suicide Initiation" was "Cancelled" per "Clinical Judgement."
* At 1948 a new physician's order was written for "Moderate Risk Suicide Initiated."
* At 2003 an RN note reflected "Pt has been placed on moderate risk at this time. On [RVM] now. Pt remains cooperative at this time." There was no reassessment or associated documentation by either RN or LIP to justify the change of SR level from High to Moderate, approximately two hours after presentation to the ED and initial assessment.
* At 2005 an RN documented on the MAR that they "Gave: 5 mg" of Haldol by mouth.
* At 2040 an RN note reflected "pt had dozed off. Woke quickly ... states 'When will Dr. [name] be here with the lethal injection?' Explained we do not have a Dr. [name]. Pt rolls [their] eyes and lays head back. Closes eyes. Pt continues on [RVM]." There was no documentation of an assessment of the patient's statement in the context of SR.

* At 2105 a note by the oncoming shift RN reflected "Assumed care of Pt Report from [outgoing RN]."
* At 2109 the RN wrote "Pt currently sleeping NADN Monitored via camera." It was unclear how the RN knew that the patient was sleeping.
* At 2130 a note reflected that "Pt sleeping medicated unable to do 12 hr admit assessment." It was not clear if the patient was sleeping at that time, or if the patient had been medicated at that time. There was no documentation of the SR four-hour reassessment due at 2136, and no indication that the patient's SR level had been changed to High per the P&P as the patient was unable to speak at that time. The EHR reflected this entry was recorded by the RN the following day, on 03/09/2022 at 0649.
* At 2227 the RN wrote "Pt sleeping NADN, Monitored via camera."
* At 2326 the RN wrote "Pt sleeping NADN Monitored via camera."

* On 03/09/2022 at 0005 the RN note reflected "SI Risk 4 Hr Reassessment Documented - Is patient sleeping? [Yes]." Although the record indicated the reassessment was "documented," there was no assessment documentation. This was approximately 6.5 hours after the initial assessment.
* At 0126 the RN wrote "Appears asleep. Resp on left side. NADN." It was unclear what "resp on left side" meant.
* At 0225 the RN wrote "Pt sleeping NADN, Monitored via camera."
* At 0300 the RN wrote "Pt up to use bathroom with Crisis Tech [name]." There was no documentation that the "SI Risk 4 Hr Reassessment" was conducted at that time while the patient was awake, approximately 9.5 hours after the initial assessment.
* At 0300 a RMT documented on a RMSSOF the following: "Quiet or Asleep" and in "Toilet/Shower with Clinical Staff" and an "RN at bedside." It was not clear whether the person the RMT documented as at the bedside was the Crisis Tech recorded by the RN at 0300 or an RN.
* At 0302 laboratory documentation reflected that a "Clean Catch Urine" specimen was "[collected]" at 0302.
* At 0312 the RN wrote "Pt sleeping at this time NADN monitored via camera."

* At 0400 a note reflected "SI Risk 4 Hr Reassessment Documented - Is patient sleeping? [Yes]." Although the record indicated the reassessment was "documented," there was no assessment documentation. This was approximately 10.5 hours after the initial assessment.
* At 0430 a note reflected "Pt sleeping NADN Respirations even and non labored monitored via camera." It was unclear how the RN knew "respirations even." The EHR reflected this entry was recorded by the RN at 0531.
* At 0533 the RN wrote "Pt is sleeping NADN Pt monitored via camera." This was the last note recorded by the night RN. There was no documentation of any assessment of the patient by the RN during the night shift. It was unclear whether the RN observed the patient in person during the shift or had relied on the Crisis Tech and RVM staff for observation of the patient.

* At 0700 a note reflected "report taken [sic] from primary nurse at this time. pt is sleeping at this time."
* At 0800 the RN note reflected "SI Risk 4 Hr Reassessment Documented - Is patient sleeping? [Yes]. Although the record indicated the reassessment was "documented," there was no assessment documentation. This was approximately 14.5 hours after the initial assessment.
* At 0806 the RN wrote "pt continues to sleep at this time."
* At 0915 a RMT documented that a "Social Worker at Bedside" and that "CNA notified" by "Telephone call." It was unclear how the RMT knew the person at bedside was a social worker and why a CNA was notified. There was no corresponding social worker or CNA documentation in the EHR.
* At 0930 the RMT documented that the patient was "Quiet or Asleep" and that they were in "Toilet/Shower with Clinical Staff."
* At 0931 the RN wrote "Pt up amb to restroom and back to room. Pt given socks per request." There was no documentation that the "SI Risk 4 Hr Reassessment" was conducted at that time while the patient was awake, approximately 16 hours after the initial assessment. Further, there was no documentation to reflect who gave the patient socks and whether the socks had been assessed for risk.
* At 1019 the RN wrote "Pt continues to rest in bed at this time."
* At 1030 the RMT documented that a "CNA notified" by "Telephone call." It was unclear why the CNA was notified and there was no "CNA" or corresponding documentation in the EHR.
* At 1115 a note reflected "Pt continues to sleep at this time. No change in [their] condition." The EHR reflected this entry was recorded by the RN at 1336.

* At 1200 a note reflected "Pt given [their] food tray but [they] does not seem to be interested in it at all." There was no documentation that the "SI Risk 4 Hr Reassessment" was conducted at that time while the patient was awake, approximately 18.5 hours after the initial assessment.
* At 1200 the RMT documented "Quiet or Asleep" and "Food."
* At 1335 the RN wrote "Pt continues to rest in bed awaiting [psychiatrist] to see [them]." There was no documentation to reflect why the psychiatrist visit had not occurred in the morning in accordance with the physician's order written the previous evening.
* At 1400 the RMT documented the patient was "Quiet/Asleep."

* At 1405 a note reflected "Pt found in room with cable around neck. Pt was unresponsive. Cable removed and Pt pinked up right away. Provider walking by at same time. Pulse found immediately and Pt moved onto gurney and then to Rm 26."

* At 1415 the RMT documented the patient was "Quiet/Asleep."
* At 1420 an RN recorded "Pt brought to Room 26. Unresponsive ... Pt easily bagged w/ 100% O2, Skin color improving ... +Carotid Pulse. HR 160's ... 1415-Pt medicated .... [LIP] @ bedside & Pt intubated ..."
* At 1430 the RMT documented the patient was "Quiet/Asleep."
* At 1430 an RN recorded the first set of vital signs since the patient's admission to the ED on 03/08/2022 at 1736.
* At 1445 the RMT documented the patient was "Quiet/Asleep." That entry had an "X" over it and was initialed by RMT 1.
* At 1500 on 03/09/2022 the RMT documented the patient was "Quiet/Asleep." That entry had an "X" over it and was initialed by RMT 1.

* ED LIP documentation electronically signed on 03/09/2022 at 1824 reflected "taking over patient care from the Crisis Unit at 9am ... Placed on 2 MD hold, admitted to crisis unit on video monitoring. Pending: Psych consultation in person this morning ... 2:30 pm I exited the patient room next door and saw [Patient 8] down on the ground, with [their] RN in the doorway calling for help. Patient was cyanotic, and unresponsive [sic]. But had palpable femoral and carotid pulses. [They] were apneic [they] was immediately [sic] moved to a resuscitation [room] for emergency evaluation and treatment. On first exam [they] was, cyanotic, [their] pupils were dilated to 6 mm bilaterally, and [they] had visible ligature marks to [their] neck. It was later noted that the patient possible strangulated [themself] with a orange cord found near [them] in the room." The note reflected that resuscitation efforts continued, and the patient was eventually accepted for transfer by another hospital that had continuous EEG capabilities.

* LIP documentation reflected that Patient 8 was transferred by "med-flight" to the receiving hospital at 1840.

* An "BH Inpatient Consult" for "Date of Service: 03/09/22" was electronically dictated by a psychiatrist on 03/09/2022 at 1504, transcribed at 1751, and electronically signed by the psychiatrist on 03/10/2022 at 1012. The narrative consultation note included history of present illness information, medical history information, "Review of Systems: Unable to obtain ... Mental Status: The patient is currently being treated for [their] acute hanging attempt ... is unresponsive ... Strengths: The patient currently is too medically ill to be responsive. [They have] no strengths at this time ... Discussion: This patient came in suicidal, psychotic and had a serious hanging attempt while in [their ED room] ... Plan: Sent to [another hospital] in Portland by plane." There was no documentation to reflect why the psychiatrist consultation did not occur as planned and as was referenced in the physician's orders for the "morning" of 03/09/2022, prior to the patient's SA.

3.b. During interview with the COO/CNO and the DQI on 03/28/2022 beginning at 1300 they provided the following information about the hospital's response to Patient 8's SA on 03/09/2022:
* The hospital began an investigation "immediately," implemented immediate changes, and corrective actions continued to be planned and implemented.
* The investigation revealed that RMT 1 assigned as primarily responsible for RVM of Patient 8 had gone on break and left RMT 2 in the RVMS alone to monitor a total of 10 patients who were at risk for suicide or falls throughout the hospital and who were assigned for RVM.
* The hospital "immediately" discontinued all RVM of SR patients and all SR patients were assigned to dedicated, in-person observation "attendants."
* The RMT assigned to Patient 8 was placed on a "leave of absence" after the incident.
* A ligature risk assessment and a "gap analysis" in the ED were conducted. Gaps in processes and systems were identified including those related to ligature risk and patient monitoring.

3.c. During interview with the COO/CNO and the DNSS, at the time of a tour and observation of the RVMS on 03/28/2022 beginning at 1430, they provided the following information related to RVM:
* At the time of Patient 8's ED encounter, the practice for observation of patients who were assessed to be moderate to high SR was RVM from the RVMS. Patients assessed with fall risk throughout the hospital were also monitored by the RVMS.
* On the day of Patient 8's encounter there were total of 10 patients throughout the hospital assigned for RVM.
* Two RMTs were assigned to the RVMS each shift.
* Each RMT had two monitors to view on which there were views of all patients assigned for RVM.
* Although the each RMT had views of all patients assigned for RVM on their own monitors, each RMT was assigned to specific rooms/patients for focused monitoring and documentation of the monitoring.
* When one RMT would leave the RVMS for a meal or break or other reason, the second RMT was responsible for monitoring all patients assigned for RVM.
* It was discovered during their investigation that RMT 1 had made personal phone calls during their shift and had left the RVMS at times other than meal and rest break times contrary to hospital P&P.

3.d. Incident, incident response and investigation documentation for Patient 8's 03/09/2022 ED encounter included the following information. The documentation was not clear or accurate:

* "[Patient 8] presented to ED with law enforcement on 3/8/22 at 1736 for SI. At 1745 the room was mitigated for risks using the [ED MHERA]. Pt was admitted with a high Suicide Risk score and initially had a 1:1 sitter ... Moderate SI Risk was ordered at 1948 ... At this point, the patient was placed on Remote Monitoring ... patient proceeded to sleep most of the night and the next day. At 1405 on 3/9/22, the RN went into the patient room to let [them] know [their parent] was there to visit and found [them] sitting on the floor leaning back against the wall with [their] feet on the bed and the monitor cord in a slip know and [sic] around [their] neck. The RN cut the cord free and lowered the patient to the floor ... moved to the resuscitation room next door, intubated, then began seizing ... was transferred out to [other hospital] at 1907 that evening for Neuro ICU and continuous EEG monitoring. The patient never regained consciousness and EEG showed anoxic brain injury ... was placed on Comfort Care ... and expired on 3/13/22 at [other hospital]. The staff in Remote Monitoring did not see the patient get out of bed. The Monitor Tech responsible for Rm. 25 ... received a personal phone call then went to break at 1405 ... did not see the patient move ... The second Monitor Tech in the room assumed care of watching all patients (10 in total) at 1405 and looked over at that room at approximately 1406 and saw the patient on the floor with a purple face and the nurse 'working on [them].'"

* Documentation of an 03/09/2022 interview conducted with the ED RN assigned to Patient 8 on 03/09/2022 reflected "The [ED] was noisy, so [Room 25] door was pulled closed so [Patient 8] could sleep since [they were] on Remote Monitoring ... [ED RN] last checked on [Patient 8] at 1335, then removed a monitor from the closet [in Room 25] a few minutes later. Patient was still sleeping at that point. [ED RN] popped in to check on the patient at 1405 because the [parent] had arrived and asked to see [the patient.] [ED RN] found [patient] sitting on the floor ... with the orange monitor cord tied in a slip knot and around [their] neck ..."

* Documentation of interviews conducted with RMT 1 on 03/09/2022 and on 03/10/2022 reflected that they were "watching ED 23 and 25 and some high fall risk rooms. The patient in 25 got up 4 times the whole shift ... Most of the day, [patient 8] was in bed with the covers up high where [RMT 1] could only see the top of [their] head ... ED room 25 had the lights off (except the light over the sink) with the door shut all day ... RMT 1 remembers last documenting in the [RMSSOF] at 1300. [They] states that [they] 'probably had some [documentation] to catch up,' [they] was 'behind 4 [time entries].' ( [sic] Of note, when the record was reviewed, clearly [RMT 1] had gone back and completed the documentation and added to it, including documenting that the patient was sleeping at 1415 and 1430 ... 1445, and 1500. The [entries] from 1445 and 1500 were x'd through with 'error.'"

* Documentation of interviews conducted with RMT 2 on 03/09

Based on observations, interviews, review of incident and medical record documentation for 5 of 5 ED patients reviewed for investigations of SA and SH incidents in the ED (Patients 2, 6, 7, 8, and 9), review of P&Ps, and review of PERA and other documentation, it was determined that the hospital failed to fully develop and implement P&Ps that ensured each patient's right to be free from all forms of abuse and neglect. Identification of, investigations of, and response to, allegations of abuse, and incidents that reflected potential neglect that resulted in actual and potential patient harm, were not clear, complete, accurate, and timely to ensure those incidents and events did not recur.

The CMS Interpretive Guidelines for this requirement at CFR 482.13(c)(3) reflects "Abuse is defined as the willful infliction of injury, unreasonable confinement, intimidation, or punishment, with resulting physical harm, pain, or mental anguish. This includes staff neglect or indifference to infliction of injury or intimidation of one patient by another. Neglect, for the purpose of this requirement, is considered a form of abuse and is defined as the failure to provide goods and services necessary to avoid physical harm, mental anguish, or mental illness."

Further, the CMS Interpretive Guidelines reflect those components necessary for effective abuse protection include, but are not limited to:
o Prevent.
o Identify. The hospital creates and maintains a proactive approach to identify events and occurrences that may constitute or contribute to abuse and neglect.
o Investigate. The hospital ensures, in a timely and thorough manner, objective investigation of all allegations of abuse, neglect or mistreatment.
o Report/Respond. The hospital must assure that any incidents of abuse, neglect or harassment are reported and analyzed, and the appropriate corrective, remedial or disciplinary action occurs, in accordance with applicable local, State, or Federal law.

Findings include:

1. Refer to the findings for Patients 6, 7, and 8 described under Tag A144, CFR 482.13(c)(2), CoP Patient's Rights - Standard: Right to safe care. Those findings reflect the hospital's failure to ensure its investigations of SA and SH incidents that resulted in actual and potential harm to patients were clear, complete, accurate, and timely to prevent recurrence.

2. Similar findings were identified for the hospital's investigations of SH incidents for Patients 2 and 9.

Based on observations, interviews, review of incident and medical record documentation for 5 of 5 ED patients who experienced SA or SH in the ED (Patients 2, 6, 7, 8, and 9), review of P&Ps, and review of PERA and other documentation, it was determined that the hospital failed to ensure that the QAPI program was effective to ensure the provision of safe and appropriate care to patients in the hospital.

This Condition-level deficiency represents a limited capacity on the part of the hospital to provide safe and adequate care.

Findings include:

1. Refer to the findings cited at Tag A115 under CFR 482.13 - CoP: Patient's Rights.

Based on observations, interviews, review of incident and medical record documentation for 5 of 5 ED patients who experienced SA or SH in the ED (Patients 2, 6, 7, 8, and 9), review of P&Ps, and review of PERA and other documentation, it was determined that the hospital failed to ensure that nursing services were organized and managed to ensure the provision of safe and appropriate care to each patient in the hospital.

This Condition-level deficiency represents a limited capacity on the part of the hospital to provide safe and adequate care.

Findings include:

1. Refer to the findings cited at Tag A115 under CFR 482.13 - CoP: Patient's Rights.

Based on review of medical record documentation for 3 of 3 BH ED patients (Patients 6, 7, and 8) it was determined that the hospital failed to ensure that electronic and handwritten medical record entries were accurate, complete, dated, timed, and authenticated.

Findings include:

1. Review of Patient 8's medical record for the ED encounter that began on 03/08/2022 revealed unclear and incomplete documentation. For example:
* An ED MHERA for the patient's ED room was dated and timed at the top of the form as completed on 03/08/2022 at 1745. The title/credential of the individual who signed the form at the bottom of the last page was not identified and the signature was not dated or timed. Further, patient information on a label at the bottom of each page of the form reflected the patient was in ED Room 24. However, the triage note and other electronic and handwritten entries elsewhere in the ED record reflected the patient was in ED Room 25. There was no other space on the form to identify what room the MHERA was being conducted for. Therefore it was not clear whether the MHERA had been conducted in Room 24 or Room 25.
* A SOF dated 03/08/2022 for the time period of 1700 through 2045 had no patient room number on it.
* A RMSSOF dated 03/08/2022 for the time period of 2000 through 2345 and an RMSSOF dated 03/09/2022 for the time period of 2400 through 0345 each had a label that denoted ED Room 24 and a handwritten entry the denoted ED Room 25 on them.. Further, the spaces for "Initials:" were blank for all 16 of the 16 observation entries on each form.
* A RMSSOF dated 03/09/2022 for the time period of 0400 through 0745 had signature of two RMTs on it. The spaces for "Initials:" were blank for all 16 of the 16 observation entries on the form and therefore it was not evident which RMT had made and documented the observations.
* A RMSSOF dated 03/09/2022 for the time period of 1200 through 1500 lacked the initials for each of the observation entries. Further, RN documentation in the medical record reflected that the patient was found at 1405 in ED Room 25 with a cord around their neck and was subsequently removed from that room for resuscitation efforts. However, there were entries recorded at 1400, 1415, 1430, and 1500 that reflected the patient had been observed to be "Quiet or Asleep." The entries for 1445 and 1500 had then been crossed out with a large "X" and "error [initials]" written next to each crossed out entry. The date and time that the "error" was documented was not recorded.
* Refer to Finding 3.a. described under Tag A144 that reflects other unclear and incomplete entries in Patient 8's medical record.

2. Review of Patient 7's medical record for the ED encounter that began on 02/02/2022 revealed unclear and incomplete documentation. For example:
* Although an ED RN entry in the medical record reflected that an ED MHERA form had been completed, the form was not evident in the medical record.
* Spaces for "Initials" on SOF forms were blank for: 02/03/2022 at 1445, 1915 and 1930.
* Similar findings regarding room numbers and authentication on SOFs and RMSSOFs to those described for Patient 8 were identified.
* Refer to Finding 4.a. described under Tag A144 that reflects other unclear and incomplete entries in Patient 7's medical record.

3. Similar findings regarding medical entries were identified in Patient 6's ED encounter that began on 11/15/2021.

Based on observations, interviews, review of incident and medical record documentation for 5 of 5 ED patients who experienced SA or SH in the ED (Patients 2, 6, 7, 8, and 9), review of P&Ps, and review of PERA and other documentation, it was determined that the hospital failed to develop and maintain the EOC in a manner that ensured the provision of safe and appropriate care to patients in the hospital.

This Condition-level deficiency represents a limited capacity on the part of the hospital to provide safe and adequate care.

Findings include:

1. Refer to the findings cited at Tag A115 under CFR 482.13 - CoP: Patient's Rights.

Based on review of P&Ps, review of staff vaccination logs, interview, observation, review of vaccination and exemption documentation for 5 of 20 staff members, SM3, SM11, SM16, SM18 and SM20, and review of other documentation, it was determined the hospital failed to fully develop and implement clearly written staff Covid-19 vaccination P&Ps in the following areas:
* P&Ps did not ensure all appropriate staff were vaccinated for Covid-19 as the hospital permitted vaccine attestations for students, contracted staff, and other staff. The hospital permitted staff to upload their own vaccination records and did not describe a process that ensured all uploaded vaccination records were verified in accordance with the hospital's "Proof of Vaccination" definition.
* P&Ps did not ensure tracking, monitoring and securely documenting vaccination status of all staff including contracted staff, non-employed staff, volunteers, and students; and staff for whom vaccination must be temporarily delayed.
* P&Ps did not ensure tracking, monitoring and securely documenting information provided by staff who had requested, and the hospital had granted, an exemption from the vaccination requirements.
* P&Ps did not ensure medical exemptions from Covid-19 vaccination contained a documented provider statement recommending a medical exemption based on medical contraindication, and information specifying which of the authorized COVID-19 vaccines were clinically contraindicated for staff to receive.

Findings include:

1. The following P&Ps and documents were reviewed:

1.a. The P&P titled "Administration A-004 COVID-19 Vaccination Policy," dated effective "November 1, 2021" provided by the hospital was reviewed and reflected:
* "In alignment with CommonSpirits's Mission and Values and to protect patients, employees, health care personnel, their families and the community ... CommonSpirit requires COVID-19 vaccination of ... Employees ... regardless of remote work status ... Service Providers ... providing services or conducting business that requires physical presence at any facility, campus, or location owned or operated by CommonSpirit ... including but not limited to non-employed physicians, allied health professionals, advanced practice providers, clinical staff, and non-clinical staff; contracted personnel; vendors; contractors; workers; students; trainees; and volunteers."
* "This Policy applies to CommonSpirit employees, its Direct Affiliates employees, as well as employees of its Subsidiaries, who are considered CommonSpirit employees ..."
* "Requirements ... Newly hired employees, who are not Fully Vaccinated at the time of hire, are expected to begin a vaccination series immediately upon hire ... Service Providers, who are making deliveries and need to enter ... a facility, campus, or location for a short duration of time to complete the delivery, are not required to be Fully Vaccinated but must be masked at all times while on the premises."
* "CommonSpirit recognizes medical and religious exemptions ... persons approved ... are subject to masking, COVID-19 testing, and other requirements established by CommonSpirit from time to time, without exception."
* "Individuals subject to this Policy must provide Proof of Vaccination (defined below) in one of the following ways ... Employees and other individuals with access to EmployeeCentral are required to upload a copy of their COVID-19 vaccine card on EmployeeCentral ... Employees and individuals who do not have access to EmployeeCentral are required to provide proof of their COVID-19 vaccine according to the process identified at their work location ... Non-employed medical staff members who are vaccinated will provide their COVID-19 vaccine records to the medical staff office responsible for their credentialing. Unvaccinated medical staff may use the exemption process established by CommonSpirit. Employed physicians, allied health professionals, and advanced practice providers who are also medical staff members will provide their COVID-19 vaccine record, or request an exemption, via EmployeeCentral, if they have access to it, or according to the process identified at their work location, if they do not have access to EmployeeCentral ... Contractors and vendors providing personnel and educational institutions or other entities providing students or trainees will track their own compliance and provide an attestation of compliance upon request or if/when a surveyor is on site and documentation is required for verification ... For educational institutions or other entities providing students ... that do not track COVID-19 vaccination or ... are not able to inquire about their students' vaccination status, CommonSpirit will allow the students to use the established process ... (e.g., provide a copy of COVID-19 vaccine card or request an exemption ...)."
* "CommonSpirit will provide masks for all individuals who receive a medical or religious exemption to the COVID-19 vaccine requirement. Those approved for an exemption will receive written instructions on proper fitting, use, wearing, and removal of the mask."
* "Masks must be worn while at CommonSpirit facilities ... Masks must be worn at all times, except in "mask free zones ... When universal masking is in place ... requirements related to universal masking may supersede the masking elements of this policy."
* "DEFINITIONS ... Mask-Free Zones: Cafeteria while eating (however, there must be social distancing for those who are not vaccinated) ... Private administrative offices with a physical barrier; and Designated areas within the facility as defined by the CommonSpirit entity or local PHD ... Fully Vaccinated: Individuals are considered fully vaccinated two weeks or more after they have received the second dose in a 2-dose regimen ... or two weeks or more after they have received a single-dose regimen ... Acceptable COVID-19 vaccines include those that are currently U.S. Food and Drug Administration (FDA)-approved, authorized for emergency use by the FDA, or recognized by the World Health Association (WHO) ... Unvaccinated: Individuals who are not Fully Vaccinated, or for whom vaccine status is unknown or documentation is not provided."
* "Proof of Vaccination is defined as one of the following ... COVID-19 Vaccination Record Card (issued by the CDC or WHO) which includes name of person vaccinated, type of vaccine provided, and date last dose was administered); or ... A photo of a Vaccination Record Card as a separate document; or ... Documentation of COVID-19 vaccination from a healthcare provider; or ... Attestation of vaccination status from an employer, contractor, vendor, or educational institution, where allowed."

The hospital's P&P did not include a process whereby the hospital ensured "Contractors and vendors providing personnel and educational institutions or other entities providing students or trainees ... " were fully vaccinated before "providing services or conducting business that requires physical presence at any facility." The P&P was unclear regarding the verification process for those staff who " ... track their own compliance and provide an attestation of compliance," as well as for staff who "upload a copy of their COVID-19 vaccine card on EmployeeCentral," such as: who checked their vaccination status, when the vaccination status was checked, and where the hospital documented that information. It was unclear if vaccinated staff were required to socially distance "while eating" as the policy only stated that in "Mask-Free Zones" such as the cafeteria, " ... there must be social distancing for those who are not vaccinated."

1. b. The P&P titled "COVID-19 Policy" dated last approved, "3/2021," provided by the hospital was reviewed and reflected:
* "PURPOSE ... To provide a standard process in response to the COVID-19 pandemic to minimize and prevent disease spread among patients, staff and visitors that includes ... environmental controls, and exposure management."
* "SCOPE ... All CHI Mercy hospitals ... "
* "Social/Physical Distancing means keeping space between yourself and other people outside of your home. To practice social or physical distancing: stay at least 6 feet (about 2 arm's length) from other people; do not gather in groups: stay out of crowded places and avoid mass gatherings."
* "Source Control ... Universal masking is a source control action to prevent the spread of Covid-19."
* "Employees: ... Universal masking is required ... Simple/procedure/isolation mask is required for those in contact with patients."
* "Face Masks: All staff ... are required to mask upon entry to any CHI Mercy facility ... Staff who interact with patients who are not in transmission-based precautions are required to wear a medical grade mask ... HCP should wear a facemask at all times while they are in the healthcare facility, including in breakrooms or other spaces where they might encounter co-workers."

1. c. The P&P titled "Privacy A-1003S Permissible Uses & Disclosure of Protected Health Information (PHI)" dated 11/01/2020 provided by the hospital was reviewed and reflected:
* "Employee Health Records ... These records may be governed by state and federal laws other than HIPAA and contain PII. They are considered confidential. Management of these records shall be formalized at each CommonSpirit entity location ... Employee Health Records must be clearly identified as employee related, not patient related ... Employee Health Records cannot be commingled in any way, (either in paper or electronically), with an employees' patient medical record or Designated Record Set ... If a copy of a document from an employee's HIPAA governed Designated Record Set from any health care provider needs to be incorporated into the Employee Health Record, the copy of the document is no longer governed under HIPAA and becomes part of the employee record, and subject to all other applicable governing laws and regulations."

1. d. A document titled "COVID-19/Influenza/Vaccine Human Resources Frequently Asked Questions with a "Revision Date: January 5, 2022" provided by the hospital was reviewed and reflected:
* "Does CommonSpirit Health require testing for unvaccinated employees? - Yes, unless otherwise indicated by state law, employees who are not fully vaccinated, and who work at a CommonSpirit facility ... will be required to test weekly (or more frequently based on state order)."
* "Do I need to wear a mask if I am approved for an exemption for either vaccine? - Yes. At this time, we will still require masking in accordance with Centers for Medicare and Medicaid Services (CMS), Centers for Disease Control (CDC) and Occupational Safety and Health Administration (OSHA) compliance."
* "Do contractors, vendors, students and volunteers need to follow CSH mandates? - Yes. Contractors, vendors, students, and volunteers accessing any CommonSpirit facility must comply with the vaccination requirement, or obtain an approved exemption. - Contractors and vendors should consult with their own employers regarding their employers' exemption process. Similarly, students should consult with their schools regarding their schools' processes. Volunteers will be provided more information regarding exemptions through each facility's Volunteer Office."

The hospital's response to frequently asked questions did not align with CMS regulations which required "A process by which staff may request an exemption ... A process for tracking and securely documenting information provided by those staff who have requested, and for whom the hospital has granted, an exemption ...". For example, regarding contractors and students, the hospital stated, "Contractors ... should consult with their own employers regarding their employers' exemption process. Similarly, students should consult with their schools regarding their schools' processes."

1. e. A document titled "Frequently Asked Questions" with a date of "Last revised on 3.17.22" provided by the hospital was reviewed and reflected:
* "What are the main changes in the current ... (CDC) masking guidance? ... CommonSpirit continues to align with CDC guidance and we will continue to mask in all patient care areas ... In administrative buildings, masks may be removed if county community level is low, but must be worn if infection risk is medium or high. In hospitals ... masks are optional in non-patient care areas for employees who are up to date on COVID-19 vaccination when the county community transmission level is low ... Masks are required in non-patient care areas for employees who are not up to date on COVID-19 vaccination and for everyone when the county community transmission level is medium, high or substantial."
* "Do vendors and volunteers need to show proof of vaccination? ... Vendors and volunteers must wear masks in patient care areas. Vendors and volunteers must show proof of vaccination in order to remove masks in non-patient care areas when community transmission levels are low."
* "When can unvaccinated employees remove their masks? ... Unvaccinated employees may remove their masks in administrative building and off-site locations when the community infection rate is low. Unvaccinated individuals must continue to wear masks in all areas of healthcare facilities regardless of community infection levels."
* "Are unvaccinated employees with medical or religious exemptions within the hospitals ... still required to test weekly? ... Testing will be suspended for all employees whether in a hospital/clinic or an administrative building - as long as infection rates are low for that location ... "
* "If vaccinated and unvaccinated staff are together in a meeting, does everyone have to wear a mask? ... It depends on ... community transmission levels ... In hospitals ... masks may be removed by individuals up to date with vaccination in non-patient care areas if infection risk is low, but must be worn in all areas if infection risk is medium or high. For meetings in patient care areas, masks are required for everyone."

1. f. A template document titled "Education Affiliation Agreement" provided by the hospital was reviewed and reflected:
* Under the section, "1.9 Student Health" was written, "Sponsoring Institution shall require all Students ... who will be on-site at Hospital, to undergo a physical examination to include the following immunizations ... COVID vaccination and/or declination."
* Under the section "1.11 Recordkeeping Requirements" was written, in its entirety, "Sponsoring Institution shall maintain and supply to Hospital, upon Hospital's request, records demonstrating Student's education and training and/or other documentation that Student's knowledge, experience, and competence are appropriate for the clinical rotation. In addition, Sponsoring Institution shall supply to Hospital, upon Hospital's request, any such records which pertain to Hospital's patients, patient care or employees. Sponsoring Institution shall be responsible for obtaining any necessary authorizations from Students for release of records."
* Under the section, "Student Participation Agreement and Waiver" was written, " ... I agree to undergo a physical health exam before the clinical education rotation begins to include immunizations ... COVID vaccination and/or declination ... "

The "Education Affiliation Agreement" contradicts CMS regulations requiring " ... all staff specified in paragraph (g)(1) ... are fully vaccinated for COVID-19, except for those staff who have been granted exemptions ... or ... for whom ... vaccination must be temporarily delayed ..." as the educational agreement stated that "before the clinical education rotation begins" that students had a choice of " ... COVID vaccination and/or declination ..." The educational agreement was not clear if "records ... and/or other documentation" maintained by the school included student vaccination records or how that information was provided to the hospital prior to the students' clinical rotations.

2. Regarding contracted (agency, temporary and traveler) staff: The hospital's P&Ps were not fully developed and implemented; and processes were unclear and did not provide assurance that contracted staff were vaccinated for Covid-19. Examples included:
2. a. An undated list of current contracted "Agency" staff with start dates between approximately 09/13/2021 and 04/25/2022 provided by the hospital was reviewed and reflected:
* At the top of the page was written "Agency Travelers."
* The list was comprised of approximately 55 staff including RNs, Dieticians, Echo Tech, Tech, and Phlebotomists.
* Departments for each staff were recorded and included but were not limited to Care Management, Clinical Nutrition, ED, Heart Center, ICU, Laboratory, Medical, PCU, RT, Sterile Prep and Surg/Peds.
* The vaccination status for 46 of the staff under the column "Vax/Ex" was recorded "Vax," and 2 were recorded as "Ex-R."

2. b. An undated list of current "AMN" contracted staff provided by the hospital was reviewed and reflected:
* At the top of the list was written "AMN (State)."
* Staff start dates were between approximately 09/22/2021 and 02/25/2022.
* The list was comprised of 33 staff including RNs, RRTs, and Phlebotomists.
* "Specialty" areas for the staff included but were not limited to ED, Surg/Peds, Medical, Respiratory, Lab, Med/Surg, ICU, PCU and Case Management.
* The vaccination status for the staff on the list was handwritten at the bottom of the list as "All vaccinated - required."

It was unclear whether the hospital had received, verified, tracked or securely documented the vaccination status of the listed contracted staff. It was unclear how that information "All vaccinated" was obtained, who verified it, or when, in accordance with the hospital's P&P that stated, "Proof of Vaccination is defined as ... COVID-19 Vaccination Record Card (issued by the CDC or WHO) which includes name of person vaccinated, type of vaccine provided, and date last dose was administered); or ... A photo of a Vaccination Record Card as a separate document; or ... Documentation of COVID-19 vaccination from a healthcare provider ... "

2. c. An undated list of current "JOGAN" contracted staff provided by the hospital was reviewed and reflected:
* At the top of the list was written "JOGAN (State)."
* Staff start dates were between approximately 09/13/2021 and 03/04/2022.
* The list was comprised of 19 staff including CNAs, Paramedic/Tech, Med Tech, RNs, RTs, and Phlebotomists.
* "Specialty" areas for the staff included but were not limited to ED, Surg/Peds, Medical, Respiratory, Lab, and ICU.
* The vaccination status for the staff on the list was handwritten at the bottom of the list as "All vaccinated - required."

It was unclear whether the hospital had received, verified, tracked or securely documented the vaccination status of the listed contracted staff. It was unclear how that information "All vaccinated" was obtained, who verified it, or when, in accordance with the hospital's P&P that stated, "Proof of Vaccination is defined as ... COVID-19 Vaccination Record Card (issued by the CDC or WHO) which includes name of person vaccinated, type of vaccine provided, and date last dose was administered); or ... A photo of a Vaccination Record Card as a separate document; or ... Documentation of COVID-19 vaccination from a healthcare provider ... "

2. d. An undated list of current CONIFER "agency" staff under contract provided by the hospital was reviewed and reflected:
* At the top of the list was written "Conifer."
* Staff start dates were not indicated on the list.
* The list was comprised of 62 staff including Patient Advocates and RNs and "Specialty" areas included billing, admitting and medical records, which was reported at the handoff by the EA/CNOO on 03/30/2022, beginning at 1010.
* The vaccination status for 57 of the staff under the column "Vaccination Status" was recorded as "Complete," 2 were recorded as "LOA," and 3 were recorded as "Exemption Approved - religious."

The list also included specific vaccines received, and the dates of each dose received, however, there was no information that reflected how that information was verified in accordance with the hospital's P&P and as defined by CMS. For example, 1 staff member had vaccine administration dates recorded as 11 days between the 1st and 2nd dose and another had vaccine administration dates recorded as 10 days between the 1st and 2nd dose. Both were recorded as having received the Pfizer vaccine and both were recorded as "Complete" although both 2nd doses were administered early. It was unclear if staff were working prior to being fully vaccinated as start dates were not included on the list provided.
Refer to Finding 2.g.: required interval between doses of the Pfizer vaccine.

2. e. An undated list of current staff "Non-employees" with varied roles, including contracted staff and "Direct Affiliates," provided by the hospital was reviewed and reflected:
* At the top of the list was written "Non-employees."
* Staff start dates were not indicated on the list.
* The list was comprised of 122 staff including RNs, CNAs, Case Managers, "clinical staff," UCC instructors, MHTs, Pharmacists, Medical Scribes, Physicians, CT Technologists, ASL Interpreters and others.
* Per the EA/CNOO at handoff on 03/30/2022, "blank areas" under the "Vax/Ex" column reflected "no on-site work" and that most were "working remotely in physician offices." However, 3 of 39 "non-employees" with "blank areas" under the "Vax/Ex" column had "on-site" recorded next to their names. Additionally, there were 19 student instructors on the list and approximately 23 contracted staff members.
* The vaccination status for 34 of the 122 staff under the column "Vax/Ex" was blank, 74 were recorded as "Vax," 3 were recorded as "Ex - R UHA," 1 as "Ex - R MMC," 1 as "Ex - M Apprvd by EFM," 4 were recorded as "Ex - R Aprvd by Vituity," 3 were recorded as "Ex - R Aprvd by CSH & Vituity," 1 as "Ex - R Aprvd by CSH, and 1 was recorded as "Ex - R."

It was unclear how or when those exemptions approved by other entities were obtained, who in the hospital verified those exemptions, or if the exemptions were approved in accordance with the hospital's P&P or as defined by CMS. It was unclear if those stafff with approved exemptions had received education on the hospital's contingency plan to include " ... written instructions on proper fitting, use, wearing, and removal of the mask." It was unclear if those staff recorded as "Vax" received doses within the recommended time frames or if they received a vaccine which was an "Acceptable COVID-19" that was "currently U.S. Food and Drug Administration (FDA)-approved, authorized for emergency use by the FDA, or recognized by the World Health Association (WHO)" as the name of the vaccine(s) received were not provided.

2.f. A list of 36 "EXPRESS" temporary staff provided by the hospital was reviewed and reflected:
* At the top of the list was written "Temp Staff."
* Staff start dates were between approximately 08/09/2021 and 02/16/2022.
* Of the 36 staff listed, approximately 23 were currently working.
* Staff included CNAs, Transporters, EVS Aides, Food Services and screeners and assigned areas included but were not limited to EVS, Food Services and ICU.
* The vaccination status for 17 of the staff under the column "Vax/Ex" was recorded "Vax," 1 was recorded as "Ex-Religious," and 5 were recorded as "Exemption."

It was unclear how or when those exemptions approved by other entities were obtained, who in the hospital verified those exemptions, or if the exemptions were approved in accordance with the hospital's P&P or as defined by CMS. It was unclear if those stafff with approved exemptions had received education on the hospital's contingency plan to include " ... written instructions on proper fitting, use, wearing, and removal of the mask." It was unclear if those staff recorded as "Vax" received doses within the recommended time frames or if they received a vaccine which was an "Acceptable COVID-19" that was "currently U.S. Food and Drug Administration (FDA)-approved, authorized for emergency use by the FDA, or recognized by the World Health Association (WHO)" as the name of the vaccine(s) received were not provided. It was unclear whether the hospital had received, verified, tracked or securely documented the vaccination status of the listed contracted staff in accordance with the hospital's P&P and as specified by CMS.

2.f.i. The "Covid -19 Vaccine Religious Exception Request Form" for SM3, a contracted employee, with a start date of "12/13/2021," was signed and dated on "12/20/2021." Corresponding documentation was provided, and the documentation reflected:
* Under "Please describe your religious belief and how it affects your ability to receive a COVID-19 vaccination," a handwritten response stated, "I don't believe its [sic] in my best interest at this time."
* Attached was a printed copy of an email dated 03/30/2022, at "4:33 PM", the 1st day of the survey. The email reflected the sender as an MMC HRBP to a contract agency service, "EXPRESS." The subject line read, "EXTERNAL Covid card for [SM3]?" Within the body of the email was a red heading, all in caps, "USE CAUTION - EXTERNAL EMAIL" and the sender's response, "I have an exemption; [he/she] has not given me an update [sic] vaccine card. [He/She] is currently tested weekly and not had a positive test since starting."

There was no further information provided for SM3. There was no documentation that SM3 had received "written instructions on proper fitting, use, wearing, and removal of the mask" per the hospital's P&P or had been educated on the hospital's contingency plan for unvaccinated employees. SM3's response did not reference a "strongly held religious belief." There was no documentation reflecting how the hospital evaluated and granted approval of SM3's exemption request when that request was made through the agency and not the hospital. There was no documentation that described how the hospital determined what accommodations, if any, were granted for SM3.

2.g. Initial and follow up interviews were conducted before, during and after the findings. They reflected:

* During an interview with DQRM and the EA/CNOO on 03/30/2022 beginning at 1010 regarding contracted agency, temporary and traveler staff members, the DQRM confirmed that the staffing agencies maintained contracted staff member's vaccination documentation as well as all exemption documentation. The EA/CNOO stated the hospital could get vaccine records from the staffing agencies "if needed." They stated that the hospital did not maintain that documentation. Additionally, when asked how the hospital ensured contracted staff members were vaccinated for Covid-19, they stated this was ensured by language in the agency contracts. Copies of the agency contracts were requested for review at that time but were not provided during the on-site portion of the survey nor were they provided after the conclusion of the on-site survey.

* During an interview with the IPEH RNs and the DQRM on 03/30/2022, the IPEH RNS were asked about the process for reviewing the Covid-19 vaccine status for new employees, including contracted staff. The IPEH RNs stated, "Employees, students, and contractors present to EH for onboarding/vaccines. They fill out paperwork, the "New Hire Employee Health Form." They further stated that IPEH RNs "... review the form with the employee and verify Covid vaccine status at the bottom of the form." If staff indicate they have received the vaccine, they collect documentation which can be a card, or an "Alert" immunization printout. The documentation is then scanned to HR. When asked about how information on the vaccination cards were verified, one IPEH RN responded, "We just look at them and make sure all the boxes are filled." A second IPEH RN stated, "We look at the dates."

* During a second interview with the DQRM and the IPEH RNs on 03/31/2022 beginning at 1350, the IPEH RNs were asked about the recommended interval between doses 1 and 2 for the Pfizer vaccine. One stated "21 days" and the other stated "3 weeks." The IPEH nurses were then asked whether a person given a dose earlier than scheduled, i.e., at 16 days, is considered fully vaccinated? Both IPEH RNs replied, "No."

3. Regarding non-employed LIPs:

3. a. An undated list of current "LIPs" provided by the hospital with the following information was reviewed and reflected:
* At the top of the list was written "LIP."
* LIP "Privileges Effective" dates were between approximately 11/01/1972 and 03/28/2022.
* The list was comprised of 214 LIPs including MDs, DOs, DPMs, PA-Cs, CNMs, RNFAs, PhDs, DMDs, QMHPs, MSWs, a dental assistant and an RPA.
* "Specialty" areas for the LIPs included, but were not limited to Hospitalist - Adult, Hospitalist - Pediatric, Cardiology, Radiology, Emergency Medicine, Obstetrics, Pulmonary and Critical Care Medicine, Anesthesiology, Podiatry, Mental Health, and General Surgery.
* The vaccination status for 206 of the LIP staff under the column "Covid Vaccination Record Card" was recorded as "Yes," 1 was recorded as "Leave of Absence," and 7 were recorded as "Religious Exception Approved."

It was unclear whether the hospital had received, verified, tracked or securely documented the vaccination status of the listed LIP staff. It was unclear how that information "Yes" was obtained, who verified it, or when, as specified by CMS.

3. b. SM11's, an LIP, "Covid -19 Vaccine Religious Exception Request Form" and corresponding documentation was reviewed and reflected:
* A follow-up approval letter sent by the hospital dated "January 7, 2022," reflected "In addition to strict compliance with wearing appropriate personal protection equipment (i.e., mask, respirator) we request the following testing. You are required to have a negative COVID-19 test within the prior seven (7) days to entering Mercy Medical Center ... It has been determined that testing will be the responsibility of your employer. Your employer is also responsible for monitoring and maintaining compliance with the surveillance of testing."

The letter did not include "written instructions on proper fitting, use, wearing, and removal of the mask" or whether SM11 was educated on the hospital's contingency plan for unvaccinated staff in accordance with the hospital's P&P. There was no information regarding the how the test results would be conveyed to the hospital or how that information would be securely documented and tracked.

3. c. During an interview with DQRM, and the 2 HRBPs on 03/31/2022 at 0930, the following information was provided:
* The DQRM stated the "Contingency Plan" for unvaccinated employees was "Weekly testing and Universal source control. All employees are required to wear face masks in the hospital and N95s while providing patient care. All staff are required to wear KN95 in non-patient care areas and a N95 in all patient care areas of the hospital, whether providing direct patient care or not when community rates are high."
* The DQRM stated that "Medical Staff exemptions for LIPs go through the hospital Medical Executive Committee" because LIPs do not have access to EmployeeCentral. When asked if this was reflected in the hospital P&Ps, the DQRM confirmed that the exemption process for LIPs is not clearly described in the hospital's P&Ps.

3. d. During a second interview with DQRM on 03/31/2022 at 1420, he/she confirmed that the exemption approval notice provided to SM11 did not contain all required elements as described in the hospital's P&P. He/she also confirmed that the hospital's Covid-19 vaccination P&P and processes were not clear and did not ensure non-employed LIP staff were fully vaccinated for Covid-19.

3. e. During an observation of the "Contingency Plan," as described by the DQRM, and the implementation of the hospital's "Source Control" protocol on 03/31/2022, from 1245 to 1258, the following was observed:
* Two SMs in scrubs were standing within 2 feet of each other in the hallway outside of the cafeteria. One SM was wearing a surgical mask appropriately while the other SM was speaking to him/her with his/her surgical mask below the nose.
* On the PCU, 1 SM wearing scrubs passed the surveyor and the DQRM wearing a surgical mask below the nose.
* On the ICU, 1 SM in scrubs was sitting at the RN station wearing a surgical mask below the nose. Another SM, identified by the DQRM at the time of the observation as a physician, was wearing scrubs and standing within 2 feet

Based on observations, interviews, review of incident and medical record documentation for 5 of 5 ED patients who experienced SA or SH in the ED (Patients 2, 6, 7, 8, and 9), review of P&Ps, and review of PERA and other documentation, it was determined that the hospital failed to ensure that emergency services were organized and managed to ensure the provision of safe and appropriate care to each patient in the hospital.

This Condition-level deficiency represents a limited capacity on the part of the hospital to provide safe and adequate care.

Findings include:

1. Refer to the findings cited at Tag A115 under CFR 482.13 - CoP: Patient's Rights.