HospitalInspections.org

Based on interview, grievance documentation reviewed for 3 of 13 patients who submitted grievances to the hospital (Patients 7, 12 and 16), and review of policies and procedures, it was determined the hospital failed to fully implement its policies and procedures that ensured patients' rights were recognized, protected and promoted:
* A written grievance notice was not provided to each patient/patient representative who filed a grievance with the hospital in accordance with the timeframes specified in the hospital's policies and procedures.
* A written grievance notice that contained all of the required elements including the name of the hospital contact person, the steps taken on behalf of the patient to investigate the grievance, the results of the grievance process, and the date of completion was not provided to each patient/patient representative who filed a grievance with the hospital.

Findings included:

1. The P&P titled "Patient Complaints and Grievances," dated last revised "12/2020" was reviewed and reflected:
* "It is the policy of the Providence Health & Services - Acute Care Facilities to respond to and resolve complaints made by patients and their representatives in a manner consistent with the Providence Health & Services Mission and Core Values."
* The Customer Care Team designee/Quality Management Coordinator/designee will work in concert with identified Department Managers to investigate and resolve complaints and grievances within their specified time frame."
* "Grievance - a 'patient grievance' is a written or verbal complaint (when the verbal complaint about patient is not resolved at the time of the complaint by staff present) by a patient, or the patient's legal representative, regarding ... Patient care ... Abuse or neglect ... Issues related to the hospital's compliance with the Center for Medicare and Medicaid Services (CMS) Conditions of Participation (COP) ... A written complaint is always considered a grievance, whether from an inpatient, outpatient, released/discharged patient or their legal representative regarding the patient care provided, abuse or neglect, or the hospital's compliance with the [COPs]; for purposes of this requirement an email or fax is considered 'written' ... When a patient or patient's representative requests that their concern be handled as a formal complaint or grievance, the concern is considered a grievance."
* "A written response to the patient or patient's representative applies to all grievances ... Grievances that are complicated or require extensive investigation should be clearly documented. If a grievance is not resolved or if the investigation requires more time, a written interim response will be sent to the patient or patient's representative within 7 business days (excludes weekends and legal holidays) from the date of receipt of the grievance to inform them that the hospital is still working to investigate and resolve the grievance ... Every attempt will be made to resolve the grievances, with final written response to the patient or patient's representative, within 14 business days from the date of receipt or identification of the grievance. For grievances extending beyond this 14 business day time frame, interim letters will be sent every 7 business days, until the grievance is resolved, to inform the patient or patient's representative that the hospital is still working to investigate and resolve the grievance ..."
* "A template written response to the patient/patient's representatives is in the DATIX feedback module and has the following elements included to ensure compliance with CMS requirements ... A. Steps taken to investigate the grievance B. Results of the grievance process C. Date of completion ... D. Name of the hospital contact person ..."

2.a. Grievance documentation for Patient 7 was reviewed and reflected:
* On 01/25/2021 the "Patient's [family member] called ... to see what needs to be done about replacing the patient's hearing aid. Was lost on 1-2-21."
* An entry dated 01/26/2021 at 1023 reflected "I spoke with [family member] gave [them] my procedures and what I will need from [them] as far as receipt, invoice, estimate going forward. 1-26-21."

2.b. The first and final written response provided to Patient 7's representative (family member) was dated 04/08/2021. There was no documentation that reflected the patient or patient's representative was provided timely written responses in accordance with the hospital's P&P. For example:
* There was no documentation that reflected a written response was provided to the patient or patient's representative within seven business days from the date of receipt of the grievance to inform them that the hospital was still working to investigate and resolve the grievance.
* There was no documentation of a written response provided to the patient or patient's representative every seven business days until the grievance was resolved, to inform them that the hospital was still working to investigate and resolve the grievance in accordance with hospital P&P.

2.c. During an interview and review of Patient 7's grievance documentation with the PCS and other hospital staff on 01/05/2022 beginning at 1540, the PCS confirmed the written response in Finding 2.a. was the only written response provided to the patient or patient's representative.

3.a. Grievance documentation for Patient 12 was reviewed and reflected that on 10/19/2021 the patient submitted a written "Formal Grievance" regarding complications from an infected pacemaker.

3.b. The first and final written response provided to Patient 12 was dated 10/28/2021. The written response included "... our team in collaboration with leadership has initiated a review of the care and services provided ... Someone from claims will be in touch with you in the near future."
* The written response did not include the steps taken to investigate the grievance or the results of the grievance process.
* There was no documentation of a written response provided to the patient every seven business days until the grievance was resolved, to inform them that the hospital was still working to investigate and resolve the grievance in accordance with hospital P&P.

3.c. During an interview and review of Patient 12's grievance documentation with the PCS and other hospital staff on 01/05/2022 beginning at 1540, the PCS confirmed the written response in Finding 3.a. was the only written response provided to the patient. The PCS stated they would check with "Risk" department to see if they had provided the patient further written responses. No further written responses were provided to the surveyor.

4.a. Grievance documentation for Patient 16 was reviewed and reflected that on 11/11/2021 the hospital received a grievance regarding a sexual abuse allegation involving the patient and an Echo Tech.

4.b. An initial written response submitted to Patient 16 dated 11/23/2021 reflected "I am writing to you to follow-up with regard to the allegation and complaint we received on your behalf from [name] related to your treatment and experience during your echocardiogram exam ... on November 11, 2021. We want to assure you that we are taking this allegation seriously, that we have a formal process for thoroughly investigating an incident such as this ... We will follow up with a written response within 7 business days of the date of this interim contact." The next and final written response provided to the patient dated 11/30/2021 did not include the results of the grievance process.

4.c. During an interview and review of Patient 16's grievance documentation with the PCS and other hospital staff on 01/05/2022 beginning at 1540, the PCS confirmed the written response did not include the results of the grievance process.

DRAFT IN PROCESS

Based on interviews, medical record and/or incident/event investigation documentation for 9 of 15 patients (Patients 1, 2, 3, 5, 17, 18, 19, 20 and 21), review of policies and procedures, and review of other documentation, it was determined that the hospital failed to develop and enforce policies and procedures to ensure patients' rights were recognized, protected and promoted and all components of an effective abuse and neglect prevention program were evident, including thorough, complete, clear and timely investigations and follow up actions of potential abuse or neglect.

The CMS Interpretive Guideline 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 Guideline reflects that 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 Protect. The hospital must protect patients from abuse during investigation of any allegations of abuse or neglect or harassment.
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.a. An incident/event and investigation document involving Patient 2 was reviewed and reflected that on 05/05/2021 at 0830 "Patient with [Do Not Resuscitate] code status, [was] prone on CT table for procedure with bradycardia and agonal breathing post drain placements. [Physician] at bedside, patient rolled onto bed in supine position. Epi given per order, oxymask in place with improved vital signs and departure to CCS [Critical Care Services]." The documentation included:
* "Event Category ... Unexpected Patient Outcome."
* "Event Subcategory ... Adult Respiratory Distress/Respiratory Arrest."
* "Extent of harm ... Harm Unknown."
* "Investigation Findings Please summarize the investigation findings (Who, What, Why, and How the event occurred)" followed by "Discussion as safety story and learnings with team during May CT staff meeting" and "Discussed with DI RN. DI RN noted that patient was positioned so that airway was obstructed by Pillow."
* "Submitter's Actions Taken ... consideration of patients positioning on table; adjust accordingly."
* "Deviation from GAPS (Generally Accepted Performance Standards) found during your investigation For example, deviation from policy/procedure, protocol, etc. ... Defaulting to CCS RN for monitoring of patient. No validation and verification of position of patient and airway."
* "Actions ... Discussed with team involved. DI RN debriefed and discussed best practices when positioning patients prone who have compromised airways ..."
The documentation lacked a clear and thorough investigation, and follow up actions. For example:
* The documentation reflected the patient was "positioned so that airway was obstructed by [pillow]," but there was no investigation that reflected how the patient should have been positioned.
* The documentation reflected "No validation and verification of position of patient and airway." There was no investigation that reflected who was responsible for validating and verifying the patient's position and airway, when that should be done or any other information that reflected how this occurred.
* The documentation reflected "prone on CT table for procedure with bradycardia and agonal breathing post drain placements." Although, the documentation reflected bradycardia and agonal breathing was "post drain placement," it was unclear how long the patient experienced these symptoms before staff identified this and intervened.
* The investigation was unclear related to the extent of harm experienced by the patient as the documentation reflected only "Harm Unknown."
* The follow up actions reflected "discussed best practices when positioning patients prone" but did not include what the best practices entailed.
* There was no investigation regarding whether staff involved in the procedure had been trained prior to the incident regarding the best practices.
* The documentation referred to best practices. However, it was not clear if the hospital developed and implemented P&Ps based on those prior to or after the incident.
* There was no investigation that determined abuse and neglect, as defined by CMS, was ruled out.
* There was no further investigation or follow up actions.
Due to the lack of clear and thorough investigation and follow up actions, there was no assurance similar incidents/events involving Patient 2 and other patients would not be prevented.

1.b. During an interview and review of the incident/event documentation in Finding 1.a. regarding Patient 2 on 01/10/2022 at 1100 with the QMC2 and other hospital staff, the QMC2 stated:
* Patient 2 underwent a CT guided drain procedure. The patient was positioned in the prone position for the procedure, and while the patient was prone, their airway was obstructed by a pillow "which would lead to agonal breathing." The QMC2 stated a pillow was used for positioning during the procedure, and the appropriate position of the pillow depended on the patient's "body habitus and communication with the patient related to their comfort." However, there was no investigation in Finding 1.a. related to whether the patient's body habitus had been considered or efforts to communicate with the patient as stated.
* The documentation reflected the patient experienced bradycardia and was given Epinephrine. However, the QMC2 stated it was not clear whether the bradycardia was the result of the incident or a symptom of the patient's underlying medical conditions. The QMC2 confirmed the investigation related to the patient's outcome and harm related to the incident was not clear.

2.a. An incident/event and investigation document involving Patient 3 was reviewed and reflected that on 09/03/2021 at 0235 "Pt found in hallway next to gray elevators. RVM in place to monitor for elopement but was not alarming. Pt on 2 physician hold." The documentation further reflected:
* "Event Category ... Elopement/Missing Vulnerable Adult (Actual/Attempt)."
* "Event Subcategory ... Elopement Attempt."
* "Harm Level ... Near Miss/Good Catch."
* "... Patient found in hallway near the elevator attempting to exit and RVM did not alarm to alert staff to patient leaving the room ... "
* "The reported time of the event was 9/3/21 at 0235. There is an adverse event documented by the RVM tech at 9/2/21 at 2014 stating: 'I was interacting in another patient's room. When I looked at this patient, [they were] outside of the door. [They] lunged at the nurse with fist clenched after [they] threatened the camera. This was after [they were] brought back to the room. I overheard the RN and security state that [they] made it to the elevator. I told staff that I did not see [them] and apologized'. The Avasys log does indicate that the [RVM tech], was intervening in another patient room at this time:
9/2/2021 20:08 Announcement intervention: 'Attention: Please do not get up!' PPMC - 8S
9/2/2021 20:08 Verbal intervention PPMC - 8S
9/2/2021 20:14 Adverse Event PPMC - Med/Surg 4L
9/2/2021 20:16 Verbal intervention PPMC - Med/Surg 4L
9/2/2021 20:18 Verbal intervention PPMC - Med/Surg 4L
9/2/2021 20:19 Verbal intervention PPMC - Med/Surg 4L
9/2/2021 20:24 Verbal intervention PPMC - Med/Surg 4L
For the time frame of 9/3/21 [at] 0235, [RVM tech] did not recall the patient exiting the room and making it to the elevators a second time that night ... the patient had been extremely agitated most of the shift with at least 2 code grays called. The time frame in the [RVM] log also shows that there were no interventions by [RVM tech] or any other caregiver during this time for this patient."
* "The RN notes in EPIC state the patient made it to the gray elevators once overnight ... The significant event documentation states:
9/2 2000 security involved for elopement and threatening behavior ... 9/2 0338 security involved for code gray 9/2 0400 security behavioral incident: code gray canceled ... 9/2 0630 behavioral incident: code gray for chasing caregiver down the hall, 4-point restraints/1:1 sitter"
* "If the patient made it to the gray elevators at 0235, [RVM tech] was giving handover to the Lead tech as [they were] going on [their] break. [They stated] this could have been the contributing factor - but [they weren't] aware this had happened. The nightshift (sic) Lead that [they] reported off to is not available for interview."
* "How did the event occur: The patient was very agitated during this shift with a lot of movement that wasn't always with the intent to leave the room ... [RVM tech] stated [they were] interacting with another patient when [Patient 3] exited the room."
* "If there was a second event at 0235 it was related to giving handover on multiple patients prior to [RVM tech] leaving for break."
* "Actions taken and/or recommendations for prevention ... Escorted pt back to room. Called RVM hub to report the missed elopement attempt."
* "Deviation from GAPS (Generally Accepted Performance Standards) found during your investigation ..." reflected "From the review of events, there were no blatant deviations from standard practice ... RVM alarm did not sound when patient exited the room."

The documentation lacked a clear and thorough investigation, and follow up actions. For example:
* The documentation was generally disorganized, included multiple dates, times and events and was not clear regarding how many times the patient attempted elopement or experienced other incidents.
* There was no investigation that reflected where the "gray elevators" were with respect to the patient's room (e.g., near the patient's room, another unit or area, another floor).
* There was no investigation related to whether the patient experienced any harm related to the incident/event. The documentation reflected only "Harm Level ... Near Miss/Good Catch."
* The "Actions" section reflected "[RVM tech] stated that 2 actions may have helped promote a timely alert to the nursing staff: 1. Placing the patient in the center of the screen for a direct view all the time. 2. Having 'second eyes' on the patient to promote greater chance for a good catch." However, there was no documentation that reflected whether or not these actions were considered and/or carried out for this patient or other patients under similar circumstances. The only documentation of follow up actions was to escort Patient 3 back to their room and report the incident/event.
* Follow up actions were specific to this patient. There were no follow up actions regarding potential future patients with similar symptoms and risks.
* There was no further investigation or follow up actions.
* There was no investigation that determined abuse and neglect, as defined by CMS, was ruled out.
Due to the lack of clear and thorough investigation and follow up actions, there was no assurance similar incidents/events would be prevented for Patient 3 and other patients.

2.b. During an interview and review of the incident/event documentation regarding Patient 3 on 01/10/2022 at 1005 with the MRVM and other hospital staff, it was stated that RVM involves a camera in the patient's room with video monitoring and two way speaking capability so that a RVM tech can see and talk to the patient and the patient can talk to the RVM tech. RVM techs are able to communicate with charge nurses, floor nurses, and CNAs. RVM techs can also activate an alarm that can be heard in the hallway to alert staff of patient related concerns. RVM techs are physically located at another hospital, PSVMC. The MRVM stated they thought the cause of the incident/event was that RVM techs monitored up to nine to ten patients at a time, and during the incident/event involving Patient 3, the RVM tech was giving a hand off report to another RVM staff. However, there was no documentation in Finding 2.a. that reflected whether these factors were considered with regard to follow up actions to prevent similar incidents/events involving this patient and other patients from recurring.

3. An incident/event and investigation document involving Patient 18 was reviewed and reflected that on 07/16/2021 at 0500 "[Physician] came to me ... informed me the CT was the incorrect study with the correct order. I spoke to CT tech, [they] had a contractor badge, and [they were] very easy to talk to. [They] reported [they] looked and saw the order incorrectly ... " The documentation further reflected:
* "Harm Level ... Minimal Harm."
* DI Manager notes dated 07/26/2021 at 1054 reflected "Tech notified by [physician that they] ordered a CTA cap for dissection. Tech stated [they were] in the middle of something and would get to [their] patient as soon as [they were] done ... 2 minutes later DCN called to find out what was taking so long. Tech explained [they] spoke with [physician] and [they would] be there in a couple minutes. 1 minute later the same DCN calls again to find out why CT hadn't come for patient yet. 1 minute later Charge Nurse called to find out what was going on ... By this time CT tech was readying scan room, told nurse to go ahead and bring patient to CT ... At this point, CT tech was flustered by multiple interruptions, saw the order as CTA Chest, did not see the rest of the order, and moved forward with a PE protocol. Shortly after patient was returned to ER, radiologist verified with the tech, PE protocol done, abd/pel was NOT done. CT tech went to bring patient back to image abd/pel when notified of a stroke on the way ... the stroke team waited outside the scan room for approximately 10 [minutes] ..."
* "Deviation from GAPS (Generally Accepted Performance Standards) ... Did not verify order with patient in room. Did not verify order prior to scanning patient. Multiple interruptions by medical team."
* "Please describe any actions taken ... Discussed process to validate orders and to verify in presence of patient. Discussed options to reduce interruptions. This includes answering phone when free of distractions and outside patient care."
The documentation reflected "Harm Level ... Minimal Harm" but there was no further description of the harm. In addition, the documentation included information about two patients. However, it was not clear which patient experienced the harm.
* There was no investigation that determined abuse and neglect, as defined by CMS, was ruled out.
* There was no further investigation or follow up actions.
Due to the lack of clear and thorough investigation and follow up actions, there was no assurance similar incidents/events involving other patients would be prevented.

4. An incident/event and investigation document involving Patient 17 was reviewed and reflected that on 12/28/2021 at 1800 the patient's "Anterior forearm IV site with heparin drip is very bruised, measuring 17.5cm x 8cm in size. Site is tender and painful. IV discontinued and extremity elevated."
* "... Contributing Factors ... Unable to Determine."
* "Skin Integrity Event Contributing Factors ... Unable to Determine"
* "Harm Level ... Minimal Harm"
* "List witnesses and/or others involved including their role ..." This was followed by the names of a primary nurse, an assisting nurse, and a day shift nurse. There was no documentation of interviews of the witnesses in effort to determine cause or potential cause.
* "Please summarize the investigation findings. (Who, What, Why, and How the event occurred)." This was followed by "No gaps in care. All policies were followed." There was no documentation that reflected how it was determined there were no gaps in care and all policies were followed.
* "Actions Taken" followed by "Removed IV that caused bruising, elevated extremity, notified provider."
There was no further investigation or follow up actions. There was no investigation that reflected whether there were other contributing factors aside from the IV.
* There was no investigation that determined abuse and neglect, as defined by CMS, was ruled out.
Due to the lack of clear and thorough investigation and follow up actions, there was no assurance similar incidents/events involving this patient and other patients would be prevented.

5.a. Incident/event and investigation documentation involving Patient 1 reflected:
* "Event date ... 12/20/2020 [Sunday] ... Event time ... 17:00"
* "Reported date ... 12/22/2020 ... Reported time ... 09:02"
* An incident/event document reflected "[Email] received from caregiver re: patient alleging inappropriate touch by the ECHO tech. QM notified and investigation started. EMAIL: Sunday 12/20 pt in [ED room number] ... after discharged by RN [name], pt came back to [their] room and requested to 'speak to the nurse [ED RN] that gave me medication when the US [staff] was here.' I was that nurse, I had given Tordol [sic]. The pt expressed concern that the 'US [staff] was inappropriate to [them]'. Stating that '[they] had me exposed the whole time until you came in - [they] then quickly covered me with a towel." I never saw any inappropriate behavior the 10 mins I was in the room. Pt was covered the whole time and tech was appropriate at such time. Pt reported to me that [they] 'had fired a gynecologist once for inappropriate behavior so this isn't the first time.' I made sure [patient] had QM number. I told [patient] straight that I never saw such behavior and [patient stated] 'I know. It happened so fast.' I am not entirely sure what to do in this situation. I did inform [the Charge Nurse] of incident."
* "Add additional details ... Met with HR [name], QM [name] ... and the accused caregiver [Echo Tech name] ... Here are the details ... Date of incident: 12/20/2020 ... Time of incident: 1300 ... Patient complained of being inappropriately touched on left breast ..."

5.b. A document regarding Patient 1 titled "Patient Abuse Allegation Investigation Plan" [Document] A reflected:
* "Step 1: Coordinate investigation team huddle ... Date: 12/21/2020 ... Time: 1300 ..."
* "Step 2: Review patient initiated concern ... Date of allegation: 12/20/2020", "Time of allegation: 1330", "First report of allegation: 12/21/2020", and "Who received reported allegation? [ED RN] ..."
* "Step 3: Interview Patient ..."
* "Step 4: Huddle with investigative Team ... [Document] C: RAT Summary from RAT (Low/High risk): Low risk ... Low Risk: Director or equivalent: Completed by: [name] Date: 12/22/2020"

5.c. An SBAR document regarding Patient 1 reflected:
* "SBAR Date: 12/22/2020"
* "Date of Incident: 12/20/2020"
* "Time of Incident: 1300"
* "Situation ... Patient complained of being inappropriately touched on the left breast by a tech ..."
* "Background ... Patient felt uncomfortable during this specific echocardiogram on 12/20/2020 ... stated Echo tech was purposely touching [their] left breast and reported the incident to the ED RN."
* "[RAT] identified incident as low risk and allegation deemed unsubstantiated ..." The document did not include the date and time the RAT was completed.

5.d. A document titled "Abuse Allegation Timeline" regarding Patient 1 reflected:
* "Date of event: 12/20/20201(sic) ... Time of event: 1330."
* "Patient reporting: [Patient 1] - patient has been discharged to home on 12/20/2020 and nowhere near the tech who performed the echocardiogram."
* "Chart review: 12/21/2020."
* "Place of event: Emergency Department Room [number]"
* "12/21/2020 at 1300 Call Conference with patient, Supervisor, and Quality Management Coordinator ..."
* "12/21/2020 at 1400 Debrief with Supervisor, Director/Manager, and QMC ..."
* "12/21/2020 at 1415 Interview with Echo Tech [name], QMC, HR, ECHO Supervisor ..."
* "12/22/2020 at 1400 Interview with ED RN (patient reported the incident to), ED Manager, QMC and HR ... RN stated [they] went to administer an anti-inflammatory medication to the patient ... The patient came went [sic] back to the ED, told the preceptor that [they] wanted to see the RN who brought [them their] pills while having the echo done. The RN was surprised to see the patient come back to the ED ... 1430: HR and QMC debrief: RAT ... completed with low risk results". There was no documentation that reflected a RAT was completed prior to 12/22/2020 at 1430.
* "12/22/2020 at 1500 The described handling of the tech to the patient's breast area is relative to the techniques described in the scope of practice for sonographers in obtaining an accurate image of the body part was found to be within normal limits and appropriate ... the allegation complaint from the patient was deemed unsubstantiated ... HR will reach out to Echo Manager to inform employee [that they] will resume work as scheduled."

5.e. The medical record for Patient 1's 12/20/2020 ED encounter was reviewed with hospital staff on 01/06/2022 at 1540. The record reflected:
* The patient presented to the ED on 12/20/2020 at 1306 with a chief complaint of chest pain and shortness of breath.
* At 1342 Echo exam ordered.
* At 1411 the ED RN documented that Torodol (an anti-inflammatory drug) was given to the patient. This was the only documentation in the medical record that reflected the ED RN gave the patient an anti-inflammatory drug.
* At 1452 the Echo Tech in the alleged incident documented that the Echo exam "Started".
* At 1453 the Echo Tech documented that the Echo exam "Ended".
* At 1512 the Echo imaging final result was completed.
* At 1612 "Patient discharged".
* On 12/21/2022 at 1314 "Manager Notation Abuse allegation received. Investigation initiated." There was no other information in the medical record regarding the incident involving the patient.

The investigation documentation was unclear and not thorough. Examples included:
* The time of the incident was not clear. The times were documented as both 1300 and 1700 in Finding 5.a., 1300 in Finding 5.c, and 1330 in Finding 5.d. The medical record was inconsistent with these times as it reflected the echo exam started at 1452, completed at 1453, and the patient discharged at 1612 as described in Finding 5.e.
* The documentation in Finding 5.d. reflected the ED RN administered an anti-inflammatory drug to the patient during the Echo exam. However, the medical record documentation in Finding 5.e. reflected the ED RN administered Torodol (an anti-inflammatory drug) at 1411. However, the Echo exam did not start until 1452, 40 minutes later.
* The documentation was not clear regarding the date and time the patient returned to the ED and reported the incident to the ED RN.
* The documentation was not clear regarding the date and time the ED RN reported the incident to the Charge Nurse. This was confirmed in an email from the DQM dated 02/11/2022 at 1518. The email reflected "It is not specifically noted in the documentation when the communication between the RN and the Charge Nurse occurred. It is implied ... that it was sometime after the event and during that shift."
* There was no documentation that reflected the Charge Nurse or any other staff reported the incident to the House Supervisor or designee immediately after the event, or at any time in accordance with the P&Ps regarding weekends and after business hours as described in Findings 7.a. and 7.b. This was confirmed in an email from the DQM dated 02/11/2022 at 1518. The email reflected "There is no specific documentation regarding a report to or from the House Supervisor."
* There was no documentation that reflected the House Supervisor initiated an investigation in accordance with the P&P regarding weekends and after business hours as described in the P&Ps in Findings 7.a. and 7.b.
* There was no documentation that reflected staff initiated interventions to ensure the patient and other patients were safe for the time between when the patient initially reported the incident to hospital staff and when the RAT was completed and determined the incident was "low risk" and unsubstantiated. The documentation reflected only "... patient has been discharged to home on 12/20/2020 and nowhere near the tech who performed the echocardiogram." It was unclear how this was determined sufficient for ensuring Patient 1's safety if the patient was to return to the ED, and the safety of other patients during the time between when the patient initially reported the incident and when the RAT and investigation were completed.

6.a. Similar findings were identified regarding lack of thorough, complete and timely investigations and follow up actions for the following patient incidents:
* Patient 1 (the same patient as described in Findings 5.a. through 5.e. above), incident/event date 12/02/2020 categorized "Level of Care Issue" involving administration of pain medication.
* Patient 5, incident/event date 12/06/2020 categorized "Protocol and Procedure Issue" involving lack of monitoring the patient in accordance with P&Ps and physician orders.
* Patient 19, incident/event date 03/05/2021 categorized "Intra-Operative Issue" involving surgical count discrepancies during the patient's surgical procedure.
* Patient 20, incident/event date 04/28/2021 categorized "Burn" involving a patient who was burned from spilled chicken broth.
* Patient 21, incident/event date 02/01/2021 categorized "Alleged abuse" involving an allegation that a hospital staff inappropriately touched the patient.

6.b. Refer to Tag A-395 under CFR 482.23(b)(3) - Standard: Staffing and Delivery of Care that reflects the hospital failed to ensure an RN supervised and evaluated the nursing care of Patient 5 on 12/06/2020 in accordance with P&Ps and physician orders.

7.a. The P&P titled "Abuse Identification and Intervention," dated effective "04/2020" was reviewed and reflected:
* "The purpose of this policy is to provide guidelines for the identification, intervention and reporting of patients in abusive situations. Additionally, guidelines are provided regarding follow up of patient allegations of abuse or harassment involving Providence Health and Services employees/caregivers."
* The "Patient allegations of abuse or harassment involving Providence Health and Services staff" section reflected:
- Definition ... Inappropriate behavior may include comments, slurs, jokes, gestures, innuendoes, graphics, writings, and pranks based on an individual's sex, race, ethnicity, religion, marital status, military status, disability, sexual orientation, political ideology, or any other legally protected characteristic."
- "Physical contact which means inappropriate touching, evidence of rape, assault with or without weapon."
* The "Process, Reporting and Documentation of Patient allegations of abuse or harassment involving Providence Health and Services staff" section reflected:
- "Notification of the incident ... Complaint received in the Department/Clinic from any of the following: Department/Clinic, Quality Management (QM), Compliance and Integrity, Human Resources (HR), Registered Nurse/Caregiver or Patient/Patient Family Member ... Complaint is reported immediately to Nurse/Clinic Manager, Site Medical Director, Nursing Supervisor, Nurse Quality Supervisor, Charge Nurse, Core Leader or other staff, who defines the allegation as an incident under the definitions listed above."
- "Manager, Core Leader, or notified staff immediately contacts QM and HR who will together begin the Patient Abuse Allegation Process Flow ... After normal business hours and on weekends the House Supervisor (or Ministry/Clinic Designee) will be notified immediately."
- "Actions to be taken ... Involved caregiver is taken out of direct contact with the patient. Caregiver will be placed on paid administrative leave at the discretion of the investigation team ..."
- "After normal business hours and weekends the House Supervisor (or Ministry/Clinic Designee) will begin investigation ..."

7.b. A document titled "Patient Abuse Allegation Process House Supervisor (HS)/Ministry/Clinic Designee after normal business hours or weekends," dated 11/10/2020 was reviewed and reflected:
* "PHS caregiver notified of patient (PT) inappropriate interaction (abuse/neglect) and/or inappropriate interaction with PHS Caregiver (CG)"
* "Caregiver notifies [Charge Nurse]"
* "[Charge Nurse] notifies House Supervisor (HS)/Ministry Designee"
* "HS/Ministry Designee initiates investigation plan and notifies chain of command for the location ..."
* "Interview patient with 2 people if possible"
* "Complete Risk Assessment Tool [RAT]"
* "Huddle with investigation team (AOC off hours) and review and initiate any appropriate considerations"
* "Determine if any caregivers need to be placed on administrative leave"
* "HS/Ministry Designee handover to onsite investigation team ... for remaining process."

7.c. A document titled "Interventions for ensuring patient safety and security in the event of abuse allegation" [Document] G dated "Updated 9.11.2020" reflected "When an allegation of abuse is received by a caregiver, it is essential to ensure patient safety ... When putting protection measures in place, the safety plan must be individualized to the specific allegation received. A plan should be developed by the Core Leader or House Supervisor, and Security Services and may include interventions such as: ... If a caregiver is identified in the allegation, a 'Risk Assessment Tool' (RAT) is to be completed to assist in determining if that caregiver is to be removed from patient contact and sent home on Administrative Leave ... If the allegation is unclear and/or the alleged perpetrator cannot be identified, interventions may include (but are not limited to): ... Ensure 2 caregivers present for all patient interactions ... Minimize unnecessary entry into patient area ... Security officer presence ... Secure video surveillance if available ... Report to law enforcement ... Notification of/support from family ... Social Work engagement ... Ensure that patient's interdisciplinary team is aware of any security measures in place."

7.d. The document titled "Core Leader - Abuse Allegation/Investigation - FAQ" dated "Updated 09/11/2020" reflected:
* "Is an employee/caregiver always placed immediately on paid [administrative] leave? ... Generally yes. This is to ensure safety to our patients and retain integrity in an investigation. This is a team decision based on information gathered ... If no immediate information is available on historical performance, previous abuse allegation (sic), recommendations is to place caregiver on administrative leave ... Are there exceptions? ... There can be, the HR, QMC and Ministry/Clinic's designee's will know when these exceptions apply and Director level input may be considered as well. The results of the [RAT] is helpful in making this decision. When in doubt, place the caregiver on administrative leave." Refer to Finding 5.d. that reflects a RAT was documented as completed 12/22/2020 at 1430, approximately two days after the patient's ED visit on 12/20/2020.

Based on interview, documentation in the medical record of 1 of 1 patient with hypoxia reviewed for provision of nursing services (Patient 5), and review of policies and procedures it was determined that the hospital failed to ensure the RN monitored and evaluated the patient's condition including vital sign and pulse oximetry in accordance with physician orders and policies and procedures.
* The alarm for the vital signs and pulse oximeter equipment was not audible from outside the patient's room because the door was closed.

Findings include:

1. The P&P titled "Regional Nursing Minimum Documentation Reference" dated last reviewed "09/2020" reflected:
* "Vital signs - Medical/Surgical
Admission: T, P, R, BP, SpO2 (if indicated by condition) within 4 hrs.
Ongoing: Q 8 hrs ... as condition warrants."
* "Assessment - Medical/Surgical
Admission: Focused Assessment within 4 hrs.
Ongoing: Individualized focused assessment upon assumption of care and as condition warrants."

2. The P&P titled "Adult Universal: Assessment, Care Planning, and Discharge" dated last reviewed "02/2018" reflected:
* "The nursing care of each patient shall be the responsibility of a registered nurse (RN)."
* "The RN is responsible for performing a focused and comprehensive assessment. The focused assessment and applicable screening is determined by the reason for admission."
* "On Assumption of Care:
A. Upon assumption of care and with changes to the patient condition document items ... (See addendum H for documentation frequency) ...
Addendum H: Cross-Walk for Assessments and Documentation Frequency. Assumption of Care. Focused Assessment, Skin Assessment, IV Site and fluid rate (Document every 4 hours), Assess tubes and lines (Document every 4 hours), Pain Screening, Monitor pertinent labs.
B. Exchange information with off-going caregiver ...
C. Perform and document purposeful rounds to assure patient safety is maintained.
D. Perform and document an individualized focused assessment. The frequency and comprehensiveness of assessments and interventions should be adequate to detect changes early enough in the course of the patient's stay to treat and/or allay undesirable outcomes.
E. Assess patient's current pain rating ..."
* "Ensure a safe environment: Assure that pertinent clinical alarms are activated with appropriate settings and at a volume audible to nursing staff."

3. Review of the medical record of Patient 5 reflected:
* An MD order dated 11/24/2020 at 0912 reflected "Vital signs, Frequency: Q4."
* An FNP order dated 11/25/2020 at 0748 reflected "Pulse oximetry, continuous."
* An MD Clinical note dated 12/05/2020 at 1508 reflected "Covid positive 11/20. Chest x-ray with worsening pneumonia at the time. Antibiotics started ... Extubated on 12/3. Oxygen requirement increased overnight from 10LPM to Optiflow at 60LPM. [They] did not do well with trial of Bi-Pap this morning due to anxiety. Pulm to evaluate this afternoon and help determine whether to consider transfer back to ICU for Bi-Pap with Precedex."
* An RN Clinical note dated 12/06/2020 at 0642 reflected "Pt sleeping between cares, A/O, VSS on 50L at 70%, no complaints of pain this shift ..."
* A Pulmonologist FNP Clinical note dated 12/06/2020 at 0821 reflected "... respiratory failure requiring intubation 11/26-11/3 ... Tolerated 10 L nasal cannula post extubation 12/4. Increasing hypoxemia requiring OptiFlow up to 100% early morning 12/5. On 70-80% FiO2 today ... If [they require] increasing oxygenation 100%, I would recommend transfer to the ICU consideration of trial of BiPAP with Precedex vs reintubation."
* An MD Clinical note dated 12/06/2020 at 1512 reflected "Oxygen requirement increased upon transfer from ICU ... [They] did not do well with trial of Bi-pap due to anxiety."
* an RN Clinical note dated 12/06/2020 at 1818 reflected "[Patient] reamains [sic] on heated high flow nasal cannula. Now at 50L and 80% fio2. De-saturates with activity and conversation to mid to low 80's. A&O x4, does endorse shortness of breath and becomes tachypneic often. Encouraged cough and deep breathing, soft proning, position changes and IS. Will continue to need close monitoring."
* An AGACNP Significant Event note dated 12/07/2020 at 0639 reflected "This provider contacted [family] via phone informing them of the patient's death. All questions and concerns addressed at that time. Family soon thereafter presented to the hospital. This provider offered support and addressed additional questions/concerns outside the patient's room. Relayed information regarding the pulse oximeter and the OptiFlow being off. Deferred to nursing on questions regarding "alarms" and "response to alarms."
* An MD Discharge Summary Note dated 12/08/2020 at 0751 reflected "Oxygen requirement increased upon transfer from ICU (10L -> 60LPM/80%). [They] underwent a trial of Bi-pap therapy with improvement in oxygenation, though was unable to tolerate due to anxiety. On the evening of 12/6/2020, RN went to do a nightly med pass and found patient to be cyanotic, hypoxemic, and unresponsive. Patient was found without pulse oximeter in place and Optiflow was off. Code Blue was called. Patient was found to be pulseless. CPR was started. ECG revealed asystole. [Patient] was given 6 rounds of epinephrine and consistent chest compressions over the course of 25 minutes without return of spontaneous circulation. Asytole was the persistent rhythm. Resuscitation discontinued. Patient expired at 2215."
* Vital signs documented by the RN on 12/06/2020 at 0756 were Temperature 36.5 C Axillary, Pulse 90, Respirations 28, BP 110/73. Oxygen sats 90% on 50L/70% FiO2 HHFNC. The next documentation of vital signs was 12/06/2020 at 1634, more than eight hours later and those were Temperature 36.4 C Axillary, Pulse 79. Respirations 26, BP 107/69, O2 93% on 50L/80% FiO2 HHFNC, demonstrating the patients oxygen needs had increased and vital signs were completed every 4 hours as ordered and per hospital policy.
* The last RN assessment documented was dated 12/06/2020 at 1001.
* The "Cardiac Arrest Record" reflected that the patient was found unresponsive and pulseless on 12/06/2020 at 2150, nearly 12 hours after the last RN assessment.

4. During interview with the 8N NM and 8N CN on 01/06/2022 at the time of the medical record review, the 8N NM stated the dynamap pulse oximetry/vital sign machine's alarm was not audible outside of the patient's room. The patient's door was closed, due to the patient being on COVID precautions. They were also unable to determine how long the patient was without oxygen before being found pulseless.