HospitalInspections.org

Based on observation, interviews, review of policies and procedures, review of state licensing documents, review of physical environment risk and safety documentation, and review of other documentation, it was determined that the hospital failed to fully develop and implement policies and procedures that ensured patients on the BHU were provided care in a safe physical environment that was in compliance with FPS state licensing requirements.
* Patients occupied the new BHU prior to a required FPS state licensing inspection, and final FPS approval; and
* Unsafe items, furnishings, and other conditions identified during FPS state licensing inspection, were not corrected and/or mitigated, and patients continued to occupy the BHU. Uncorrected items and conditions included but were not limited to rigid/sharp, outside corner surfaces in a seclusion room used for patients at risk for self harm, medical gas outlets accessible to patients, window blind control knobs throughout the unit that created ligature risks and other risks of self harm, ineffective acoustic ceiling treatments that caused patient agitation, and hospital style beds that created ligature and other patient safety risks.

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 under Tag A700, CFR 482.41 - CoP: Physical Environment. Those findings reflect the hospital's failure to ensure patients received care in a safe physical environment that was in compliance with FPS state licensing requirements.

2. The P&P titled "Behavioral Health Services - Operational Plan (ARRMC)," dated effective 07/23/2020 was reviewed and reflected "Care is guided by the standards put forth by the Department of Patient Care Services and the Behavioral Health Unit Policies and Procedures based on ... Oregon Statutes and Administrative Rules."

3. The P&P titled Provision of Patient Care - Operational Plan (ASANTE)," dated effective 08/05/2020 was reviewed and reflected:
* " ... System level policies and procedures are implemented as appropriate with feedback from various stakeholders. The review of plans, policies, and procedures considers at least: ... regulatory requirements ... "

4. Review of the following P&Ps and other documents reflected they failed to include a clear process that ensured compliance with FPS state licensing requirements and processes, including prohibiting patient occupancy on the BHU or other units prior to final FPS approval, required prior to occupancy:
* "BHU Admission Safety Guidelines," dated effective 06/03/2020;
* "Behavioral Health Services - Operational Plan (ARRMC)," dated effective 07/23/2020;
* "Camera Monitor-Behavioral Health Unit (ARRMC)," dated effective 08/03/2020;
* "Outdoor Area Policy (ARRMC)," dated effective 09/24/2020;
* "Provision of Patient Care - Operational Plan (ASANTE)," dated effective 08/05/2020;
* "Safety Measures for the Behavioral Health Unit (ARRMC), dated effective 09/24/2020;
* "Suicide Prevention," dated effective 04/11/2019.
* An untitled document with the heading "Behavioral Health Unit September 2020" provided in response to a request for the hospital's BHU environmental risk assessment and corrective actions.

Based on observations, interviews, documentation reviewed in the medical records for 3 of 3 patients (Patients 1, 13 and 15), incident/event and investigation documentation reviewed for 14 of 18 patients (Patients 1, 3, 4, 5, 8, 9, 10, 11, 12, 13, 15, 16, 17 and 18), review of policies and procedures, review of state licensing documents, review of physical environment risk and safety documentation, review of staff orientation/training materials, and review of other documentation, it was determined that the governing body failed to ensure the provision of safe and appropriate care to patients in the hospital that complied with the 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 under Tag A020, CFR 482.11 - CoP Compliance with Laws.

2. Refer to the findings cited under Tag A115, CFR 482.13 - CoP Patient Rights.

3. Refer to the findings cited under Tag A263, CFR 482.11 - CoP Quality Assessment and Performance Improvement.

4. Refer to the findings cited under Tag A700, CFR 482.41 - CoP Physical Environment.

Based on observations, interviews, documentation reviewed in the medical records of 3 of 3 patients (Patients 1, 13 and 15), incident/event and investigation documentation reviewed for 14 of 18 patients (Patients 1, 3, 4, 5, 8, 9, 10, 11, 12, 13, 15, 16, 17 and 18), review of policies and procedures, review of state licensing documents, review of physical environment risk and safety documentation, review of staff orientation/training materials, and review of other documentation, it was determined that the hospital failed to develop and enforce policies and procedures to ensure patients received safe care, and were provided care in a safe physical environment; and failed to ensure patients' rights were recognized, protected and promoted as follows:
* Patients on the inpatient BHU were not provided care in a safe physical environment that was in compliance with FPS state licensing requirements.
* Patients on the inpatient BHU and BHU outdoor area, and route to the BHU outdoor area were not provided care in a safe, physical environment that was free of ligature risks, and unsafe items, and areas; and risks had not been identified and/or mitigated, and staff were not trained to identify and mitigate those risks.
* A patient was not ensured safe care and was burned during an MRI procedure while under general anesthesia; and another patient with an unsteady gait and confusion, was allowed to leave the MRI department without supervision, and was subsequently found with his/her oxygen tubing on the ground and buttocks exposed.
* A frail patient with fragile skin and recent hip surgery experienced pain after staff left him/her laying on an X-ray board.
* A severely psychotic patient at high risk for elopement and self neglect, was not provided safe care and was allowed to elope multiple times, including from the secure/locked inpatient BHU after following staff out a BHU exit door.
* A suicidal, psychotic patient was not ensured safe care and was allowed to access a pillow case and use it to "strangle" him/herself while in the ED seclusion room. Another patient in the ED, who was experiencing behavioral symptoms, was allowed to access and hide a sharp pencil and broken/sharp toothbrush contrary to hospital policies and procedures.
Additional safety related incidents included but were not limited to patients handcuffed by "security", MRI monitoring equipment "not working properly," medication oversedation, medication omissions, falls, RRT processes, and CIWA policies.
* The hospital failed to conduct clear, complete, thorough and timely investigations and follow up actions of incidents/events in accordance with hospital policies and procedures, including those of potential or actual abuse and neglect that involved potential or actual harm, to ensure those events did not recur.

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 under Tag A020, CFR 482.11 - CoP Compliance with Laws.

2. Refer to the findings cited under Tag A700, CFR 482.41 - CoP Physical Environment.

3. Refer to the findings cited at Tag A144, CFR 482.13(c)(2) - Standard: Patient's Rights: Care in a Safe Setting.

4. Refer to the findings cited at Tag A145, CFR 482.13(c)(3) - Standard: Patient's Rights: Free From Abuse/Harassment.

Based on observations, interviews, documentation reviewed in the medical records of 3 of 3 patients (Patients 1, 13 and 15), incident/event and investigation documentation reviewed for 14 of 18 patients (Patients 1, 3, 4, 5, 8, 9, 10, 11, 12, 13, 15, 16, 17 and 18), review of policies and procedures, review of state licensing documents, review of physical environment risk and safety documentation, and review of other documentation, it was determined that the hospital failed to develop and enforce policies and procedures to ensure patients received safe care, and were provided care in a safe physical environment; and failed to ensure patients' rights were recognized, protected and promoted as follows:
* Patients on the inpatient BHU were not provided care in a safe physical environment that was in compliance with FPS state licensing requirements.
* Patients on the inpatient BHU and BHU outdoor area, and route to the BHU outdoor area were not provided care in a safe, physical environment that was free of ligature risks, and unsafe items, and areas; and risks had not been identified and/or mitigated, and staff were not trained to identify and mitigate those risks.
* A patient was not ensured safe care and was burned during an MRI procedure while under general anesthesia; and another patient with an unsteady gait and confusion, was allowed to leave the MRI department without supervision, and was subsequently found with his/her oxygen tubing on the ground and buttocks exposed.
* A frail patient with fragile skin and recent hip surgery experienced pain after staff left him/her laying on an X-ray board.
* A severely psychotic patient at high risk for elopement and self neglect, was not provided safe care and was allowed to elope multiple times, including from the secure/locked inpatient BHU after following staff out a BHU exit door.
* A suicidal, psychotic patient was not ensured safe care and was allowed to access a pillow case and use it to inflict self harm ("strangle" him/herself) while in the ED seclusion room. Another patient in the ED, who was experiencing behavioral symptoms, was allowed to access and hide a sharp pencil and broken/sharp toothbrush contrary to hospital policies and procedures.
Additional safety related incidents included but were not limited to patients handcuffed by "security", MRI monitoring equipment "not working properly," medication oversedation, medication omissions, falls, RRT processes, and CIWA policies.

Findings include:

1. Refer to the findings cited under Tag A020, CFR 482.11 - CoP Compliance with Laws.

2. Refer to the findings cited under Tag A700, CFR 482.41 - CoP Physical Environment.

3. a. Review of the P&P titled "Responsible Event Reporting and Analysis in a Culture of Safety (Asante)," effective 04/17/2018 was reviewed and reflected:
* "This policy is designed to ... Guide employees in accurately reporting the details of patient or visitor safety events that occur within Asante ... Encourage the contribution of information about safety events or potential events without fear of recrimination ... Assist in identifying human and system problems that affect patient care."
* "A Responsible Event Report (RER) is completed for any event that is not consistent with routine patient care or routine operations of the facility. An RER should be completed when an abnormal/unusual event has, or threatens to have, an adverse effect on a patient or visitor, and justifies evaluation or corrective action. The event report is completed by the employee who ... Participated in the event ... Witnessed the event ... First discovered the event ... or First received a report of the event."
* "Complete the event report by stating what happened, clearly and concisely ... Be sure to briefly mention the circumstances around whom or what was the cause of the event. Review all fields to ensure you have answered the questions who, what, when, where, and how ... Notify the physician of the incident if a patient is involved."
* "Events should be reported electronically using the Midas system ... in full detail as soon as possible after the incident occurs and submit to your Manager, Supervisor, or House Supervisor ... "
* "The Unit/Department Manager or Supervisor of the most appropriate department will ... Investigate and document follow-up of all event reports within a two-week time frame from when the event report was entered ... Make any needed system changes to help prevent incident from occurring again ... Evaluate the nature of the error(s) and develop action plans to appropriate (sic) address the error(s) ... "
* "The following is a list of circumstances requiring a Report ... This list is not intended to be all-inclusive ... Injuries to patients or visitors ... Falls ... Suicide attempt ... Elopement/AMA ... 'No Harm' near misses ... Error (omission or commission) ... Policy, rules, or standards not followed that affect a patient ... Pressure ulcers acquired after admission ... Other skin integrity issues ... Documentation/Consent Issues ... Inappropriate Behavior Issues ... Laboratory Events ... Complaint and Care Concerns ... Medication errors ... "

3. b. Review of the P&P titled "Elopement Precautions," dated effective 01/17/2020 reflected:
* "Any patient considered to have a risk of elopement who is on the open unit will be placed on a minimum of 15-minute checks ... Any patient on EP may be required to wear hospital attire at staff discretion ... Patients on EP should not have shoes ... in their possession ... A patient on EP will be requested not to remain at or near the unit exits ... "

3. c. Review of the P&P titled "Suicide Prevention," dated effective 04/11/2019 reflected:
* "Suicide Precautions ... The nurse provides a safe environment for the patient on suicide precautions, utilizing the following measures ... Provides one-to-one observation for any patient who is not in a ligature resistant environment ... patient is not to be left unattended ... Secure all patient belongings and places patient in Asante-designated psychiatrically safe attire ... If a patient refuses ... to change into approved attire, staff shall monitor the patient closely while seeking additional support staff. When all attempts at gaining the patient's cooperation have been exhausted, the physician is notified ... Removes potentially dangerous objects from the room (See Addendum A ... )." Addendum A, attached to the P&P reflected "Purpose: To provide a safe and secure environment for patients and staff. Assess the room for patients who exhibit a potential for self-destructive or violent behaviors ... Remove all sharp objects, actual or potential weapons ... from the room. Though not an exhaustive list, examples of potential weapons include ... Extra linens ... There is no substitute for close observation ... "
* "For patients in ligature resistant environments continuous visual monitoring is maintained, either in-person or via camera."

3. d. Review of the P&P titled "Code Gray," dated effective 09/02/2016 reflected:
* "Whenever assistance is needed to control a situation or physically restrain a patient or other person, the staff involved will call the emergency number ... All available trained staff hearing the Code Gray paged are to respond ... and await instructions from the staff person in charge ... Responding staff should be instructed what to expect before confronting the patient or situation ... To avoid confusion and possible conflict, only one staff member should talk to the patient/person. Preferably this will be the staff member calling the code or assigned as caregiver to the patient ... This person will make the determination whether to use restraints and provide direction to responding staff for the safest method of restraining ... The least amount of force necessary to maintain safety will be used. A 'show of support' is often enough to defuse a situation and obtain cooperation ... After safety is established, interventions will be guided by use of least restrictive measures and protection of patient rights, dignity, and well-being ... "

3. e. Review of the P&P titled "Restraint and Seclusion," dated effective 04/16/2020 reflected:
* "This policy applies to all patients, regardless of patient care setting or diagnosis ... Restraint: Any manual method, physical or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move his arms, legs, body, or head freely ... "
* "The use of restraint or seclusion is limited to emergencies only. Restraint or seclusion is initiated only when less restrictive interventions have been ineffective and when there is an imminent risk of injury to self and/or others. Asante does not permit restraint or seclusion for any other purpose, such as coercion, discipline, convenience or retaliation by staff ... "
* " ...Exemptions: The use of handcuffs, spit masks, or other restrictive devices applied by law enforcement officials who are not employed by or contracted by the hospital when the use of such devices is for custody, detention, and public safety reasons, and is not involved in the provision of care. The application, monitoring, and removal of forensic devices are the responsibility of the law enforcement officers. The hospital and its staff are responsible for providing safe and appropriate care to the patient."

3. f. Review of the Imaging P&P titled "MRI Anesthesia Safety," dated as originated on 10/03/2016 reflected:
* "Purpose: To outline the process and proper pre-screening and scanner selection for patients undergoing sedated MRI examinations."
* "[ARRMC] has (2) MRI scanners, (1) 1.5T and (1) 3.0T. Each scanner has different field strengths and different safety requirements."
* "All patients will be screened for implants prior to appointment to determine if an MRI is contraindicated ... All patients will be thoroughly re-screened prior to appointment to determine the presence of any condition or implant that is contraindicated for MRI imaging."
* "Scanner Selection ... All MRI Anesthesia patients will be routinely scheduled on the 1.5T scanner ... Anesthesia will only be performed in the 3T environment based on ordering Physician requirements or patients' body habitus makes it unsafe to perform anesthesia in the 1.5T scanner."
* "The MRI technologist is responsible for the safety of the patients, staff and scanner in the MRI environment and will make the final determination for safety of any equipment, etc." The P&P did not include a process for evaluating patient's body habitus to determine if they were safe or unsafe for anesthesia in the 1.5T scanner. For example, although the P&P stated the MRI techologist was "responsible for the safety of patients ... and will make the final determination for safety of any equipement," it was unclear if the MRI technologist was responsible for determining safety and equipment related to body habitus.

3. g. Review of the Imaging P&P titled "MRI Personnel and Visitor Screening (ARRMC)," dated as originated on 02/18/2014 reflected:
* "Screening forms must be completed by person(s) entering the MRI environment be it patient or visitor. In the circumstance where a patient cannot complete the screening form the next of kin will be asked to complete on their behalf. When next of kin is not available, ordering physician will be required to complete screening form ... Patient or visitor will not be permitted entry into the MRI suite until a screening form is completed and signed by person completing the form."
* "No one with a pacemaker, battery operated devices, electronic devices, or other similar implanted devices, is allowed to enter the restricted magnetic field area unless verified and cleared by MRI technologist ... No metal objects are permitted ... unless determined to be MRI safe/MRI Conditional by MRI technologist ... No pain patches, medication patches, or electrodes may be on the skin ... No person with the history of a metal/shrapnel injury to the eye or body will be permitted to the MRI suite until a screening radiograph has been performed and reviewed by the radiologist."

3. h. Review of the P&P titled "Contraindications to MRI Scanning/Screening (ASANTE), dated effective 12/20/2019 reflected:
* "Purpose: To identify patients and/or conditions whereby MRI is contraindicated."
* "At time of patient scheduling, a number of screening questions will be asked. On arrival, all patients will fill out an MRI questionnaire. Once tech and patient reach patient dressing rooms across from MRI, the tech will review all answers on questionnaire with patient, performing a double check. (Scan patient questionnaire in PACS.)."

3. i. Review of the Imaging P&P titled "Thermal Burns in MRI," dated approved 10/17/2016 reflected:
* "Purpose: To prevent excessive heating and possible burns in association with MR procedures ... damaged radiofrequency coils, physiologic monitors, electronically-activated devices, and external accessories or objects made from conductive materials have caused excessive heating, resulting in burn injuries to patients undergoing MR procedures."
* "Prepare the patient for the MR procedure by using insulation material (i.e. appropriate padding) to prevent skin-to-skin contact points and formation of 'closed loops' from touching body parts ... Insulating materials (minimum recommended thickness, 1-cm) should be placed between the patient's skin and transmit [radio frequency] coil that is used for the MRI procedure ... There should be no direct contact between the patient's skin and the transmit [radio frequency] coil of the MR system."
* "Closely monitor the patient during the MR procedure. If the patient reports sensations of heating or other unusual sensation, discontinue the MR procedure immediately and perform a thorough assessment of the situation."

4. a. Regarding Patient 1: Review of incident/event and investigation documentation reflected that on 04/04/2019 at 1400 the patient experienced a burn during an MRI procedure. The documentation reflected:
* The "Date Received" was 04/12/2019, eight days after the incident occurred.
* The "Reporter Description of Event" section was blank.
* The "Type" section reflected "Skin Integrity, Equipment Related, With Injury."
* The "Outcomes:" section reflected "Deep Tissue Injury Burn Necrosis Pain Pressure Ulcer, Stage II."
* The "Why did this event occur and how could it have been prev (sic):" section reflected "Unsure."
* "Risk" notes dated 04/12/2019 at 1258 reflected "Pt states [he/she] received a burn from the MRI. [Physician] and Clinic RN assessed wound today 4/12/19. It is a stage 2 ulcer secondary from (sic) thermal radiation frequency burn. Pt reports wound was new after MRI. Chart review notes MRI [RN] documented injury post MRI."
* ISM notes dated 04/16/2019 at 0848 reflected "Do (sic) to patient habitus the left arm was up and the right arm was down during the scan. Pt was under [general anesthesia] and was unable to communicate any discomfort during the procedure. Pt had elbow pads on for safety and this should have prevented any burns to the elbow region while in the MRI unit. The Tech states that elbow pads were in the proper location when the pt was removed from the MRI unit ... anesthesiologist noted the hard lump on the pt right elbow and applied ice to that site ... MRI was very cautious when putting this patient in the MRI and going forward, MRI will cancel the procedure if there is any problems getting a patient into the MRI unit."
* ISM notes dated 04/23/2019 at 0820 reflected "The patient habitus was one of the factors that lead up to this incident ... Patients (sic) elbow must have been touching the inside of the MRI ring and this was due to [his/her] size. The other was the elbow pads, my (sic) hypothesis is when the Techs moved the patient into the MRI unit, the elbow pads rolled up a bit and then the elbow pad slid back into place when the patient came back out of the MRI unit."
* SMRI notes dated 04/22/2019 at 1558 reflected " ... anyone that large would have to be considered a risk/complication ... Nobody seemed to know how the elbow pads slipped when they brought [him/her] out to administer the contrast, and because [he/she] was sedated [he/she] could not tell them it was hurting."

The documentation lacked a timely and thorough investigation as required by hospital P&Ps. For example:
* There was no documentation that reflected the incident report and investigation were initiated until 04/12/2019, eight days after the incident was identified by staff on 04/04/2019. There was no investigation that identified the lack of a timely event report and investigation, and no documentation of follow up to this.
* The documentation reflected "going forward, MRI will cancel the procedure if there is any problems getting a patient into the MRI unit." It was unclear what was meant by "problems getting the patient into the MRI." For, example, it was unclear whether staff did or did not have problems getting the patient into the MRI, and if so, what the problems were.
* The documentation reflected the patient was "sedated," his/her habitus and size created a risk that lead up to the incident, and his/her elbow must have touched the inside of the MRI. However, there was no investigation that reflected whether the hospital had developed and implemented appropriate P&Ps to prevent this risk. For example, P&Ps that ensured sedated patients were appropriately monitored, and body habitus evaluated prior to the MRI procedure; and patient management during the procedure, including checking the patient and pads, to prevent injuries.
* There was no investigation that reflected whether abuse and neglect, as defined by CMS, were ruled out.

Due to the hospital's failure to conduct a timely, complete and thorough investigation, and subsequent follow up actions, there was no assurance similar incidents involving other patients would not occur.

4. b. During an interview with the SMRI, ISM and other hospital staff on 07/08/2021 at 1400, the following information was provided regarding the incident involving Patient 1:
* On 04/04/2019, the patient underwent an outpatient MRI lumbar spine and pelvis procedure with and without contrast under general anesthesia.
* The patient's body habitus was a risk factor because he/she was "a bigger [person]." When he/she was inside the MRI, his/her body was in close proximity to the interior surfaces of the MRI [bore], and therefore "[he/she] needed to be checked more frequently" because the bore generated heat during the procedure.
* Patients not under general anesthesia during an MRI procedure were able to "squeeze a ball" to inform staff if they experienced heat or pain while in the MRI. However, Patient 1 was under general anesthesia during the MRI procedure and was unable to squeeze a ball or notify staff when his/her body made contact with the bore or experienced pain or heat during the procedure.
* Staff applied pads to the patient's arms before the procedure to reduce the risk of his/her arms making contact with the bore and being burned.
* After the start of the MRI procedure, staff brought the patient out of the MRI to administer contrast media and other tasks. Staff checked the arm pads during those times and they were "okay."
* At the end of the procedure when the patient was brought out of the MRI, the right arm pad was curled up, the patient's skin was exposed, and he/she had a "red area" on his/her arm.
* A week after the MRI procedure, the patient presented to an urgent care clinic with a third degree burn wound on his/her arm, and subsequently required outpatient wound care for treatment of the wound.
* For patients under general anesthesia, the usual process was that staff used pads to protect the patient's exposed skin from making contact with the bore and being burned, and also brought the patient out of the MRI "periodically" during the MRI procedure to check the placement of the pads. However, the ISM stated the the hospital had no P&Ps that described evaluating patient body size/width (habitus) prior to MRI to determine proximity to the bore, or bringing the patient out of the MRI and checking the pads, including when, how frequently, and by whom.
* The P&P titled "MRI Anesthesia Safety" above was reviewed during the interview. The SMRI stated the patient underwent his/her MRI in the 1.5T scanner, but "probably" should have had the MRI in the 3T scanner instead because of his/her body habitus.

4. c. Review of the Imaging P&Ps in findings 3. f. through 3. i. above lacked a clear process for monitoring patients for potential burns during an MRI procedure while under general anesthesia, including patients with potential body size/habitus considerations. For example, although the P&P "Preventing Thermal Burns in MRI" reflected "Closely monitor the patient during the MR procedure. If the patient reports sensations of heating or other unusual sensation, discontinue the MR procedure immediately," this was not feasible for Patient 1 or other patients under general anesthesia because they would not be able to "report sensations of heat or other unusual sensations." The P&P did not include how frequently a patient should be checked while under anesthesia or otherwise unable to report sensations of heat or other unusual sensations, what should be checked, by whom, or consideration of body size/habitus.

4. d. Review of the hospital's list of incidents/events that occurred during provision of imaging (radiologic) services for 01/07/2019 through 10/02/2020 reflected the MRI incident involving Patient 1 on 04/04/2019 was not received until 04/12/2019, and there was no documentation that an investigation of the incident was initiated until 04/12/2019.

4 e. In an email from the VPQ dated 07/14/2021 at 1257 regarding the incident involving Patient 1, the VPQ confirmed the lack of timely incident report and investigation. The email reflected "No they did no (sic) file an incident report prior to the [clinic] visit." No further information was provided related to the lack of timely incident report and investigation.

4. f. Review of the medical record of Patient 1 reflected the patient was admitted to the hospital on 04/04/2019 and experienced a burn during an outpatient MRI procedure while under general anesthesia as follows:
* "Events" notes reflected:
- At 1240 "Ready for Procedure."
- At 1241 "Anesthesia Start."

* A "Screening Form" section that was not completed reflected "Appointment Information ... 4/4/2019 1:00 PM"
- "Procedure ... MRI Pelvis [with] [without] Contrast"
- "Screening Form Questions" followed by "No Answers have been answered for this form."
This was followed by spaces for recording the "Patient Signature," "Date," "MRI Safety Officer Signature" and "Date." All of the spaces were blank.
- "Begin Exam Questions ... Does the patient have any foreign bodies such as devices, heart valve replacements, implants, aneurysm clips, joint replacements or metal fragments i.e. from a welder or grinder in his/her body?," "Answer," and "Comment" each followed by a blank space.
- "Enter location of metal or additional metal here:" followed by a blank space.

* "Events" notes reflected:
- At 1330 "Entire position rechecked, all pressure points padded, no direct contact with scanner."
- At 1404 "Entire position rechecked, pressure points padded."
- At 1429 "Procedure Complete."
* The RN notes at 1435 reflected "Pt returned to MRI recovery ... "
- The "Events" notes at 1442 reflected "Anesthesia Stop."
* RN notes at 1448 reflected " ... Ice pack applied to sore area distal to right elbow which is new after MRI."
* RN notes at 1458 reflected " ... CMS in right hand and arm, pt denies numbness and tingling, pain isolated to small round area below right elbow. Oral pain medication provided ... [Physician] at bedside provided IV fentanyl ... Pt reporting some relief of pain."
* Anesthesia notes electronically signed by a DO dated 04/04/2019 at 1507 reflected " ... Painful lump noted by patient on medial aspect of right forearm ... Cold compress applied. Pt instructed to see PCP if not better within a few days or to seek immediate medical treatment if [he/she] develops numbness on (sic) weakness in that arm ... "
* "Imaging" notes reflected an "MRI pelvis with and without contrast" were performed "04/04/19 1256 - 04/04/19 1521;" and "MRI lumbar spine with and without contrast" were performed "04/04/19 1256 - 04/04/19 1522."

* RN notes at 1531 reflected "Pt d/c'd ... Ice pack continues on right elbow ... "

* "MRI Imaging in RRMC MRI Imaging SBAR Handoff" notes reflected "Problem List ... Cellulitis of forearm, right, Burn of forearm, right, third degree, subsequent encounter ... "

* A "Pre MRI/MRA Safety Screening" form in the record contained incomplete, undated, untimed, lined through, and illegible entries; and lacked documentation the patient was appropriately screened for risk factors prior to the MRI procedure. The safety screening form reflected:
- "Height: 5 [feet] 10 [inches] Weight: 379." The pre-printed writing directly below this entry was lined through with a Sharpie pen and was illegible.
- The form included 34 contraindications, conditions, considerations and other factors with yes/no checkboxes next to each. "Yes" was checked for "Anxiety or Panic attacks," "Port-a-cath," "History of tumor or cancer? ... Colon," "Diabetes?," and "Hypertension? (High Blood Pressure)."
* The form was signed by the patient and dated 04/04/2019 but not timed when it was signed.
* The "form completed by:" section was blank.
* The bottom of the form reflected "MRI staff verifies all patient related equipment has been removed or validated for MRI safety. Initials:" followed by a blank line with no initials.
Although the form was signed by the patient and dated 04/04/2019, there was no documentation that reflected the patient completed the form prior to the MRI procedure; and no documentation that reflected staff reviewed the form, and screened and verified the patient was safe to undergo the MRI procedure.

4. g. In an email from the VPQ dated 07/13/2021 at 0904 regarding the incident involving Patient 1, the VPQ confirmed the lack of MRI safety screening form. The email reflected "There is no Technologist-signed documentation in the patient's record that reflects that this was done prior to the MRI procedures. The Technologist who started this exam no longer works for Asante, so we cannot consult them about this." No further information was provided related to the lack of MRI safety screening.

5. Regarding Patient 3: Review of an incident/event document reflected that on 01/28/2020 at 1225 "I was walking to [MRI] to pick up the patient and as [I] got to the time clock area [I] find this patient pushing the wheelchair. [His/her] oxygen tubing was dragging on the ground. [His/her] butt was showing. [He/she] was confused."
* "Why did this event occur and how could it have been prev (sic):" reflected "Patient was left unattended and was able to walk [him/herself] and the wheelchair right out the door. could have walked right out the building. could have been prevented if the staff were paying attention."
* "Outcome: Patient Care Compromised"
* "Comments:" dated 01/30/2020 at 1459 reflected "EMR indicates that this patient is moderately unsteady on feet. Can it be explained why patient was walking from MRI alone?"
* "Comments" dated 02/05/2020 at 1313 reflected "I had a discussion with the staff ... let them know they must be aware that we are responsible for our patients' safety when they are in our department ... This patient should not have been allowed to leave the holding area on [his/her] own recognizance. This is a total patient care issue."

The documentation lacked a thorough investigation as required by hospital P&Ps. For example:
* There was no investigation that reflected how long the patient had been gone from the MRI area before he/she was found.
* There was no investigation that reflected why or how the patient was left unattended and permitted to leave the MRI area alone. The documentation reflected contributing factors were "Lack of Attention." However, there was no documentation of staff interviews or other efforts to determine what caused the lack of attention (e.g., distractions, staffing).
* There was no documentation that reflected the incident was evaluated for compliance with hospital P&Ps, as applicable. For example, P&Ps related to management and monitoring confused patients during provision of imaging services.
* There was no investigation that reflected if abuse and neglect were ruled out.
There was no further investigation or follow up actions.

6. Regarding Patient 18: Review of incident/event and investigation documentation reflected that on 09/26/2020 at 2330 " ... patient had been complaining of pain on bilateral hips and groin (surgery was on left hip) ... was about to be turned onto [his/her] side when a staff member hit something hard on the bed under the patient, object was slid out from under patient. Under the fabric incontinent pad was a white back board. Patient was instantly more comfortable. Patient is very frail and has fragile skin ...Looking into the chart, patient had [his/her] post-op X-RAY done at 1730 ... "
* "Why did this event occur and how could it have been prev (sic):" reflected "Back board under patient was not removed ... "
* "Comments" dated 10/07/2020 at 1537 reflected "Tech placed white board under patient to obtain the lateral hip x-ray. Board should've have (sic) been removed upon completion of exam ... "
* "Outcome: Pain"

The documentation lacked a thorough investigation as required by hospital P&Ps. For example:
* There was no further information that reflected why the patient was left laying on the board. The documentation reflected only "Lack of Attention." There was no documentation of staff interviews or other efforts to determine the cause or potential cause of the lack of attention.
* There was no investigation that reflected how long the patient was left laying on the board.
* The documentation reflected the patient had "multiple [dressings] over bony prominences including coccyx and back, anterior hip ... " and "No Detectable Harm." However, it was unclear how it was determined there was no detectable harm as there was no investigation that reflected the patient's skin was assessed after laying on the board, and determined whether he/she did or did not experience skin injuries as a result of the incident.
* There was no investigation that reflected if abuse and neglect were ruled out.

There was no further investigation. Due to the lack of investigation, there was no assurance similar incidents involving other patients would not occur.

7. a. Regarding Patient 15: Review of incident/event and investigation documentation reflected that on 08/12/2020 "Pt eloped by following the housekeeper out the NE door. Staff caught [him/her] by elevator." The documentation further reflected:
* "Type: General, Policy & Procedure Not Followed."
* "Why did this event occur and how could it have been prev (sic):" reflected "Staff be more aware when entering or leaving unit. Do not let pt have personal clothing especially shoes."
* "Results of Interview w/Staff:" followed by a blank space.
* "Was this event preventable?:" followed by a blank space.
* "Was there a gap in Standard of Care and/or P&P":" followed by a blank space.
* "If you identified a gap, please describe:" followed by a blank space.
* "Please provide the action plan(s) to prevent reoccurrence:" followed by a blank space.
* "Comments" dated 08/13/2020 at 0947 reflected "For managers to review, include referral to EVS for reminder to staff to be aware while exiting, close doors behind you ... regarding patient having their own clothes/shoes-was protocol followed for this patient?"
* "Comments" dated 08/21/2020 at 1511 reflected "This patient does constant exit seeking when [he/she] is on the unit. We have had [him/her] many times over the years and it is like an impulse [he/she] can't control. All staff need to be extra alert when [he/she] is with us. We put extra signage on the doors. [He/she] has a doctors (sic) order to stay in hospital clothes with no shoes. [He/she] is extremely vulnerable and at great risk if [he/she] elopes and we are unable to find [him/her]."

The documentation lacked a thorough investigation and follow up actions as required by hospital P&Ps. For example:
* It was unclear how the patient who was extremely vulnerable and a known elopement risk, was able to follow an EVS staff out a BHU door and elope.
* There was no invest

Based on interviews, documentation reviewed in the medical records of 3 of 3 patients (Patients 1, 13 and 15), incident/event and investigation documentation reviewed for 14 of 18 patients (Patients 1, 3, 4, 5, 8, 9, 10, 11, 12, 13, 15, 16, 17 and 18), 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 as defined by CMS, and potential or actual harm, to ensure those incidents did not recur. Patient incidents included:
* A patient was not ensured safe care and was burned during an MRI procedure while under general anesthesia; and another patient with an unsteady gait and confusion, was allowed to leave the MRI department without supervision, and was subsequently found with his/her oxygen tubing on the ground and buttocks exposed.
* A severely psychotic patient at high risk for elopement and self neglect, was not provided safe care and was allowed to elope multiple times, including from the secure/locked inpatient BHU after following staff out a BHU exit door.
* A suicidal, psychotic patient was not ensured safe care and was allowed to access a pillow case and use it to inflict self harm ("strangle" him/herself) while in the ED seclusion room. Another patient in the ED, who was experiencing behavioral symptoms, was allowed to access and hide a sharp pencil and broken/sharp toothbrush contrary to hospital policies and procedures.
* A frail patient with fragile skin and recent hip surgery experienced pain after staff left him/her laying on an X-ray board.
* Additional safety related incidents included but were not limited to patients handcuffed by "security", medication oversedation, falls, medication omissions, RRT processes, MRI monitoring equipment "not working," and CIWA policies.

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. Refer to the findings cited under Tag A144, CFR 482.13(c)(2) Patient Rights: Care in a Safe Setting. Those findings reflect the hospital's failure to ensure investigations of actual or potential abuse and neglect were timely, thorough and complete to prevent recurrence for 14 of 18 patients reviewed who experienced incidents.

Based on observations, interviews, documentation reviewed in the medical records of 3 of 3 patients (Patients 1, 13 and 15), incident/event and investigation documentation reviewed for 14 of 18 patients (Patients 1, 3, 4, 5, 8, 9, 10, 11, 12, 13, 15, 16, 17 and 18), review of policies and procedures, review of state licensing documents, review of physical environment risk and safety documentation, review of staff orientation/training materials, and review of other documentation, it was determined the hospital failed to develop, implement, and maintain an effective QAPI program to ensure the provision of safe and appropriate care to patients in the hospital that complied with the Conditions of Participation in the following areas:
* Staff failed to ensure patients received safe care, in a safe physical environment that complied with FPS state licensing requirements.
* Staff failed to conduct thorough, complete, clear and timely investigations and follow up actions of potential abuse or neglect, and potential or actual harm, to ensure those did not recur in the following cases:
- A patient was not ensured safe care and was burned during an MRI procedure while under general anesthesia; and another patient with an unsteady gait and confusion, was allowed to leave the MRI department without supervision, and was subsequently found with his/her oxygen tubing on the ground and buttocks exposed.
- A severely psychotic patient at high risk for elopement and self neglect, was not provided safe care and was allowed to elope multiple times, including from the secure/locked inpatient BHU after following staff out a BHU exit door.
- Patients on the inpatient BHU and BHU outdoor area, and route to the BHU outdoor area were not provided care in a safe, physical environment that was free of ligature risks, and unsafe items, and areas; and risks had not been identified and/or mitigated, and staff were not trained to reduce those risks.
- Patients on the inpatient BHU were provided care in a physical environment that was not safe and in compliance FPS state licensing requirements.
- A suicidal, psychotic patient was not ensured safe care and was allowed to access a pillow case and use it to inflict self harm ("strangle" him/herself) while in the ED seclusion room. Another patient in the ED, who was experiencing behavioral symptoms, was allowed to access and hide a sharp pencil and broken/sharp toothbrush contrary to hospital policies and procedures.
- A frail patient with fragile skin and recent hip surgery experienced pain after staff left him/her laying on an X-ray board.
- Additional safety related incidents included but were not limited to patients handcuffed by "security", medication oversedation, medication omissions, falls, RRT processes, MRI monitoring equipment "not working," and CIWA policies.

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 under Tag A020, CFR 482.11 - CoP Compliance with Laws.

2. Refer to the findings cited under Tag A115, CFR 482.13 - CoP Patient Rights.

3. Refer to the findings cited under Tag A700, CFR 482.41 - CoP Physical Environment.

Based on interview, review of incident/event and medical record documentation for a patient who was burned during provision of outpatient MRI services at the hospital (Patient 1), and review of radiologic policies and procedures, it was determined the hospital failed to fully develop and implement radiologic policies and procedures that were effective and prevented patients from injuries as follows:
* Policies and procedures were not fully developed and implemented to prevent patient burns during MRI procedures for patients under general anesthesia or otherwise sedated, including consideration of body size/habitus, and monitoring during the procedure.
* MRI safety screening checklists were incomplete, and lacked documentation patients were screened prior to MRI procedures.

The CMS Interpretive Guideline for this requirement at CFR 482.26(b) reflects:
* "The hospital must adopt and implement radiologic services policies and procedures that provide safety for affected patients and hospital personnel and which are consistent with accepted professional standards for radiologic services."
* "MRIs are useful when a soft tissue injury or disease process is suspected ... Potential risks include ... thermal injury and burns ... "
* "In order to ensure safety and freedom from hazards, the hospital's radiologic services policies and procedures must include, but are not limited to, provisions addressing the following ... Policies and protocols to identify patients at high risk for adverse events for whom the radiologic study or procedure might be contraindicated ... Procedures to address risks associated with modalities that do not use ionizing radiation. For example, with respect to MRI ... Measures to reduce the risk of thermal injuries/burns during MRI. This would include, but is not limited to, screening patients to identify those who may have metallic tattoos or metal in them, proper patient positioning, ensuring implants are MR Conditional, checking for electrically conductive materials that might be in close proximity to the patient and taking the appropriate precautions, and instructing the patient to immediately report any burning sensations experienced during the scan."

Findings include:

1. Refer to the findings identified under Tag A144, CFR 482.13(c)(2) - Standard: Patient Rights: Care in a Safe Setting. Those findings reflect the hospital's failure to fully develop and implement radiologic P&Ps that ensured patients were not burned during MRI procedures; and were screened for MRI safety prior to MRI.

Based on observation, interviews, documentation reviewed in the medical records of 2 of 2 patients experiencing behavioral symptoms (Patients 13 and 15), incident/event and investigation documentation reviewed for 3 of 18 patients (Patients 13, 15, and 17), review of policies and procedures, review of state licensing documents, review of physical environment risk and safety documentation, review of staff orientation/training materials, and review of other documentation, it was determined that the hospital failed to fully develop and implement clearly written policies and procedures that ensured the physical environment was constructed, arranged and maintained for the safety of patients as follows:
* Patients on the inpatient BHU were not provided care in a safe physical environment that was in compliance with FPS state licensing requirements. The hospital permitted patient occupancy of the unit prior to FPS approval. Numerous unsafe items including ligature and other physical environment safety risks, identified during FPS inspections, were not corrected and the hospital permitted patient occupancy of the unit.
* Patients on the inpatient BHU, BHU outdoor area, and route to the BHU outdoor area were not provided care in a safe, physical environment that was free of ligature risks, and unsafe items, and areas; and environment acoustics that created patient agitation; and risks had not been identified and/or mitigated, and staff were not trained to identify and mitigate those risks.
* A severely psychotic patient at high risk for elopement and self neglect, was not provided care in a safe physical environment and was allowed to elope multiple times, including from the secure/locked inpatient BHU after following staff out a BHU exit door.
* A suicidal, psychotic patient was not ensured care in a safe physical environment and was allowed to access a pillow case and use it to "strangle" him/herself while in the ED seclusion room. Another patient in the ED, who was experiencing behavioral symptoms, was allowed to access and hide a sharp pencil and broken/sharp toothbrush contrary to hospital policies and procedures.

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 under Tag A115, CFR 482.13 - CoP: Patient's Rights. Those findings reflect the hospital's failure to ensure patients received care in a safe physical environment.

2. Refer to the findings cited under Tag A701, CFR 482.41(a) - Standard: Physical Environment: Maintenance of Physical Plant. Those findings reflect the hospital's failure to fully develop and implement P&Ps that ensured patients received care in an environment that was constructed, arranged, and maintained to ensure patient safety; and failed to ensure the physical environment was in compliance with FPS state licensing requirements.

Based on observation, interviews, documentation reviewed in the medical records of 2 of 2 patients experiencing behavioral symptoms (Patients 13 and 15), incident/event and investigation documentation reviewed for 3 of 18 patients (Patients 13, 15, and 17), review of policies and procedures, review of state licensing documents, review of physical environment risk and safety documentation, review of staff orientation/training materials, and review of other documentation, it was determined that the hospital failed to fully develop and implement policies and procedures that ensured the physical environment was arranged and maintained for the safety of patients as follows:
* Patients on the inpatient BHU were not provided care in a safe physical environment that was in compliance with FPS state licensing requirements. The hospital permitted patient occupancy of the unit prior to FPS approval. Numerous unsafe items including ligature and other physical environment safety risks, identified during FPS inspections, were not corrected and the hospital permitted patient occupancy of the unit.
* Patients on the inpatient BHU, BHU outdoor area, and route to the BHU outdoor area were not provided care in a safe, physical environment that was free of ligature risks, and unsafe items, and areas; and environment acoustics that created patient agitation; and risks had not been identified and/or mitigated, and staff were not trained to identify and mitigate those risks.
* A severely psychotic patient at high risk for elopement and self neglect, was not provided care in a safe physical environment and was allowed to elope multiple times, including from the secure/locked inpatient BHU after following staff out a BHU exit door.
* A suicidal, psychotic patient was not ensured care in a safe physical environment and was allowed to access a pillow case and use it to "strangle" him/herself while in the ED seclusion room. Another patient in the ED, who was experiencing behavioral symptoms, was allowed to access and hide a sharp pencil and broken/sharp toothbrush contrary to hospital policies and procedures.

Findings include:

1. Refer to the findings cited under Tag A115, CFR 482.13 - CoP: Patient's Rights. Those findings reflect the hospital's failure to ensure patients received care in a safe physical environment.

2. The P&P titled "Behavioral Health Services - Operational Plan," dated effective 07/27/2020 was reviewed. The P&P described the BHU as follows: "The inpatient Behavioral Health Unit (BHU) is a 24-bed secured environment that provides treatment to individuals in an acute/critical phase of mental or emotional disturbance. The unit is open 24 hours a day/ 7 days a week. In addition to these 24 beds, there are two seclusion beds for intermittent and restricted use and secure outdoor area ... The Behavioral Health Unit serves adults ages 18 years and over, focuses on short term intensive treatment, with an average length of stay of 9 days. Patients served include ... diagnosis such as depression, bipolar disorder, schizophrenia, PTSD, etc ... Rogue Regional Medical Center's Behavioral Health Unit exists to provide inpatient psychiatric treatment for people with acute, major mental disorders who are likely to benefit from short-term stabilization ... Majority of Diagnosis of patients admitted to the BHU ... Suicide ideation ... recurrent major depressive disorder ... Schizophrenia ... Acute psychosis ... PTSD ... Depression with suicide ideation ... Severe manic bipolar 1 disorder with psychotic features ... Paranoid schizophrenia ... "

3. a. During an interview with the BHU Manager on 10/07/2020 at 1705, the BHU Manager stated the hospital had a new inpatient BHU with 24 beds, dining room, patient lounge, group room, and OT room, and was a locked unit that required "badge access" to enter and exit the unit.

3. b. During an interview with the DQ on 10/08/2020 at 1325, the DQ provided the following information regarding the new BHU:
* Construction commenced on the BHU on 05/22/2019, and was completed on 05/22/2020.
* Patients began occupancy of the BHU on 05/28/2020.
* A state FPS inspection of the unit was not conducted until "June" after patients were already occupying the unit.
* The DQ confirmed the hospital had not received a state FPS final project approval of the BHU as of the time of the interview. The DQ confirmed patients occupied the unit prior to an FPS inspection of the unit, and prior to the state FPS final project approval of the unit required prior to patient occupancy.

4. Tours and observations of the new BHU, BHU outdoor area and route to the BHU outdoor area were conducted with the BHU Manager and other hospital staff on 10/07/2020 beginning at 1705 and on 10/08/2020 beginning at 1050. Patients were observed occupying the unit during the tours. Observations of unsafe areas, items, ligature risks, and other safety risks throughout the unit that created the likelihood for patient harm, and were not identified on an environmental risk assessment, and mitigated based on a risk assessment included but were not limited to the following:

* On 10/07/2020 at 1717, in the Sally-port just outside the main entry to the BHU, metal door closure devices at the top of the double doors had loopable areas that created a ligature risk.

* On 10/07/2020 in the dining room and in other areas, large garbage cans with plastic bags inside them were observed. The plastic bags created the risk of patient self harm or harm to others by asphyxiation.

* On 10/07/2020 at 1725 and again on 10/08/2020, in patient room 3414, two window blind control knobs attached to the window frame, each attached with two screws were observed. The knobs protruded from the window frame and were approximately 23 inches from the floor. The surveyors pushed on the knobs and were able to loosen them with some force. However, one of the knobs required more force to loosen than the other knob and it was questionable if they would or would not release if a patient attempted to use them as a ligature point. The knobs and screws created the risk of choking, ingestion, risk of self inflicted harm or harm to others if removed and accessed by patients. The knobs additionally created a potential ligature risk as they protruded from the window frame and it required a variable amount of force to loosen the knobs from the window frame.

During an interview with the BHU Manager on 10/07/2020 at the time of the observation, he/she stated the same window blind control knobs were present in all patient rooms on the BHU.

During an interview with the BHU Manager on 10/08/2020 at 1220, the BHU Manager was asked if he/she had any documentation from the manufacturer that reflected the window blind control knobs were ligature or tamper resistant and he/she said "I don't have anything from the architect that states the knobs are ligature or tamper resistant." An opportunity to provide additional documentation was provided. No further documentation was provided.

Refer to the FPS inspection reports dated 06/04/2020 and 09/29/2020 below that reflects the knobs presented a safety risk and were not in compliance with FPS state licensing requirements. The FPS reports reflected "Window blind controls provide a ligature risk. Knob is knurled, of significant size and depth and apparent breakaway strength is significant. Provide information indicating that blind adjuster does not present a significant ligature risk or provide alternative adjustment device" and "Per site inspection comment, square edged, heavily knurled blind controls present a ligature opportunity ... "

* On 10/07/2020 at 1738 in an alcove across the hall from the nurse station, a phlebotomy chair with numerous loopable parts including two side armrests, a front armrest, a frame with bars, and knobs with exposed screws was observed in the corner of the room. The knobs, exposed screws and loopable areas created the risk of self harm related to choking and ligature.

During an interview with the BHU Manager on 10/07/2020 at the time of the observation, the BHU Manager stated the phlebotomy chair was "probably a ligature risk."

* On 10/07/2020 at 1743, an upright refrigerator/freezer with horizontal and vertical loopable handles that created a ligature risk was observed in the main dining area.

* On 10/07/2020 at 1746, a large metal meal cart on wheels with loopable vertical handles was observed in the hall near the main dining area.

* On 10/07/2020, in patient room 3414, a hospital style overbed table was observed. There was a significant gap between the "table" and the floor that created a ligature point. The table was on wheels and also created the potential risk of pushing into other patients or staff causing harm to others. The BHU Manager stated two patient rooms on the unit had overbed tables in them.

During an interview with the BHU Manager on 10/07/2020 at the time of the observation, the BHU Manager stated the overbed tables "could be a ligature risk."

* On 10/07/2020, in patient room 3414 bathroom, a shower chair with loopable areas between the seat and back, was observed in the shower that created a ligature risk or could be picked up and used to harm others.

During an interview with the BHU Manager on 10/07/2020 at the time of the observation, the BHU Manager stated the shower chair was "probably a ligature risk."

* On 10/07/2020 at 1750 in patient room 3402, and on 10/08/2020 at 1103 in patient room 3414 adjustable hospital style beds were observed and had numerous ligature points and gaps that created the risk for entrapment including but not limited to gaps between the head board, foot board, bilateral upper and lower side rails and the mattress; and loopable bars and electrical wires on the underside of the bed that created additional ligature risks and potential for injury related to access to the electrical components of the bed.

During an interview with the BHU Manager on 10/08/2020 at the time of the observation, he/she stated the same hospital style beds were used in all patient rooms on the BHU with the exception of rooms 3408, 3409 and 3410.

Refer to the FPS inspection reports dated 06/04/2020 and 09/29/2020 below that reflects hospital style beds present significant ligature risk as well as the opportunity for other patient injuries.

* On 10/07/2020 at 1750 in patient room 3402, and 10/08/2020 at 1103, in patient room 3414 hospital bed linens and blankets typically seen on medical units in hospitals were observed on the beds in those rooms and created a ligature risk as they could be looped over items or torn and used as a ligature.

During an interview with the BHU Manager on 10/07/2020 at 1740, he/she stated the bed linens "could be a ligature risk."

During an interview with the BHU Manager on 10/08/2020 at 1215, he/she stated typical hospital linens with the exception of "fitted sheets" were used in all patient rooms "unless a patient was suicidal."

* On 10/08/2020 in a patient room, medical gas outlets were observed exposed and accessible to patients and created a safety risk if tampered with or otherwise accessed by patients.

Refer to the FPS inspection reports dated 06/04/2020 and 09/29/2020 below that reflects patients are not permitted access to medical gas outlets. The FPS report reflected "Medical gas outlets shall be located or installed to prevent patient access" and "Patients are not allowed access, cover is required ... "

* On 10/08/2020 at 1135, a phlebotomist and a phlebotomist "orientee" were observed in the hall near the BHU main entrance with a rolling supply cart. The phlebotomist pushed the cart past several patient rooms and down the hall to the alcove across from the nurse's station. The cart had numerous unsafe items on top of it including but not limited to a pair of scissors, pens, rolls of medical tape/bandages of various widths, packages of needles, syringes, plastic bags for transporting lab specimens, and a tourniquet. A sharps container was attached to the side of the cart, and an open box that contained more than 25 tourniquets was observed on a shelf on the front of the cart. None of the items were covered, locked or otherwise secured. An unlocked drawer in the front of the cart contained additional phlebotomy supplies including but not limited to rolls of tape, plastic bags and vacutainers.

During an interview with the phlebotomist at the time of the observation, the phlebotomist indicated he/she routinely came into the BHU to collect lab specimens from patients. He/she stated patients sometimes approached the cart and wanted to touch the items on the cart as he/she was rolling the cart down the hall. The phlebotomist stated his/her normal process was to enter the BHU alone with the supply cart, push the cart to the alcove across from the nurse's station, and wait in the alcove with the cart until staff brought a patient to the phlebotomy chair where he/she would collect the lab specimen.

In an email from the DQ dated 10/15/2020 at 1423, the DQ revealed that the hospital had no P&P that addressed how patient safety was ensured when the phlebotomist was on the BHU with a phlebotomy cart that contained unsafe items such as scissors, needles, a sharps container, and other items.

In an email from the DQ dated 10/16/2020 at 1250 regarding the use of phlebotomists on the BHU, the DQ indicated no training had been done for phlebotomy staff related to how to enter/exit the BHU to ensure patients did not elope, and how to respond to patients in the event they attempted to access unsafe items on the phlebotomy care, or attempted to overwhelm the phlebotomist and use the cart to harm others. The email reflected "I spoke to both our phlebotomy team and our BHU team. There is not current process in place, nor previous education given and this was identified as a gap ... "

* On 10/08/2020 at 1140, observation from the nurse station reflected the phlebotomy chair was not fully visible. Further, there was a wall mounted curved mirror near the ceiling in the alcove designed to visualize the alcove from outside the alcove. During the tour staff stated the US was "always at the nurse station" and monitored the alcove by looking at the curved mirror on the ceiling that was visible from the nurse station.

On 10/08/2020 at 1145, a surveyor positioned him/herself on the phlebotomy chair in the alcove and manipulated the knobs on the chair. From the US's seat at the nurse's station, the curved mirror in the alcove was observed but it could not be discerned what the surveyor was doing.

On 10/08/2020 at the time of the observation, the US stated that although he/she could see someone in the mirror, he/she could not discern what the individual was doing.

* On 10/08/2020 at 1150, the BHU Manager stated "We've had patients that became assaultive" and throw food, meal trays, and marking pens, and "break plastic spoons and hurt themselves, and a patient recently tried to inflict self harm by trying to wrap a sheet around [him/herself] ... [he/she] was always trying to do self harm."

* On 10/08/2020 at 1153, in the hall near the nurse station, a sliding double window leading to the medication room was observed in the hall near the nurse station. Although the window was closed at the time of the observation, items were visible on a work counter inside and and below the window including an open container with approximately 4 sharpened pencils and 10 pens inside it, a wood-like box with sharp edges that contained medication cups, a telephone and telephone cord, and a computer keyboard that created the risk of patient access to those items, and self harm, or harm to others, when the window was in the open position.

* On 10/08/2020 at 1155, during interview with the BHU Manager, he/she stated patients and "people in general" on the unit have complained about the noise level in the BHU. He/she stated patients have complained that "it's too noisy or too echoey." The BHU Manager stated "The reverberation of it is agitating to patients. I certainly feel it adds to the agitation." Refer to the FPS inspection reports dated 06/04/2020 and 09/29/2020 below that reflects the acoustic treatments were applied to common use area ceilings that did not perform as indicated, and patients were expressing agitation with the overall noise levels.

* On 10/08/2020 at 1210 in seclusion room 3415, eight loopable restraint attachment points were observed on the sides of the bed, and linens were observed on the bed including a sheet, pillow with pillow case, and thin hospital style blanket that created ligature risks.

* On 10/08/2020 at 1220 in seclusion room 3416, the outer edge of the column corner near the window was observed and had an acute, 90 degree angle made from a hard material. This hard, sharp surface created a risk for patient self harm and was observed in a seclusion room that is typically used for patients experiencing significant behavioral symptoms including self harm behaviors.

Refer to the FPS inspection reports dated 06/04/2020 and 09/29/2020 below that reflect the column corner was a safety risk. The FPS report reflected "Padding at outside column corner at Seclusion 3416 does not provide adequate cushion. ... Existing corner as provided is 90 degrees without any rounding or mitigation. Material is very hard and presents a clear danger of self-harm ... The existing condition provides two risks; 1) The corner provided is sharp. 2) The finish is hard with very little give ... "

* On 10/08/2020 at 1222, in the seclusion room bathroom, the top of the continuous door hinge had a slot or gap that was approximately 1/4 inch wide that created a ligature risk.

* On 10/08/2020 at 1240 a patient with a rolling walker was observed that had loopable areas that created the risk for ligature to the patient or other patients. The walker additionally created the risk of the patient or other patients using the walker to harm others.

* On 10/08/2020 at 1243, observation of the alcove across from the nurse station revealed an uncovered wall mounted fire strobe device near the ceiling.

During an interview with the BHU Manager on 10/08/2020 at the time of the observation, he/she confirmed the fire strobe device was not covered and he/she stated the fire strobe device should have a "psych cover" on it.

Refer to the P&P titled "Safety Measures for the Behavioral Health Unit (ARRMC)" below that reflects fire system devices "pose a ligature risk" and "will be adapted or removed from the Behavioral Health Unit."

* On 10/08/2020 at 1245, observation of the nurse station reflected it was enclosed with a clear Plexiglas-like barrier that was approximately 14 inches high that extended above and around the main nurse station desk/counter area. Several computers with cords attached and a round container of pens and sharpened pencils were observed on the nurse station desk/counter and were readily accessible to the surveyor by reaching over the Plexiglas barrier, and were therefore accessible to patients. Further, the BHU had numerous lightweight chairs throughout the unit that were accessible to patients and could be easily moved to the nurse station area and used to stand on and more easily reach into the nurse station and/or climb over the Plexiglas barrier and access other items and equipment within the nurse's station that could be used for harm to self or others. Items observed within the nurse's station included but were not limited to computer keyboards and computer mouse devices with cords, telephones and telephone cords, highlighter marking pens, a stapler, office style chairs, and an open supply room. The supply room contained additional items and equipment that could be used for harm to self or others including but not limited to an open multi-level metal shelving unit with grid-like loopable areas throughout the shelving unit. The shelving unit was stocked with numerous supplies/equipment including but not limited to plastic containers of medical fluids, boxes of gloves, packages of needles, pill splitters, rolls of medical tape, a container of toothbrushes, a bin of "safety lancets," and plastic bags containing undergarments. Additional observations in the supply room included a code cart with a defibrillator on top of it, two portable oxygen tanks directly adjacent to the code cart, an oxygen concentrator with a plastic bag on top of it that contained looped oxygen tubing, a thick electrical cord plugged into the wall, a stethoscope, a walker with numerous loopable areas, a Dinamap vital signs machine on wheels with numerous loopable areas and three or more cords coiled around it.

During an interview with the BHU Manager on 10/08/2020 at 1150, he/she confirmed none of the computers at the nurse station were attached to the desk/counter to prevent them from being lifted off the nurse station desk/counter from outside the nurse station.

* On 10/08/2020 at 1252, observation in the patient OT room revealed an iron grate-type item on the floor near the room entry that created a trip/fall risk. A heavy horizontal metal paper holder with a large roll of paper in it was observed on an open shelf approximately 3-4 feet from the ground. The paper holder had rigid, metal edges that created the risk of harm to self or others as it could be picked up and used to inflict self harm or harm to others. Other items observed in the OT room on open shelves or other open areas accessible to patients included but were not limited to a rigid ruler, a box that was labeled "100 Crayons," a thin wood-like paint brush, an electric pencil sharpener with a cord that was plugged into the wall, a rigid tape dispenser with tape in it, a roll of masking tape, an open shoe box size tote full of sharpened colored pencils, two rectangular shaped wood-like tables and 5-6 standard weight chairs positioned around the tables, a garbage can with a plastic bag inside it, a container of Dawn dish soap near the sink that created a risk of patient ingestion, and 3 boxes of SensiCare exam gloves,

On 10/08/2020 at the time of the observation, the BHU Manager was asked how patients were protected from harming themselves or others with the items in the OT room and he/she stated "I don't know. You'd have to ask OT."

* On 10/08/2020 at 1300, observations of the exit door and route used to take patients from the BHU to the BHU outdoor area with the BHU Manager and CPA revealed: The route included exiting a non-Sally port locked door from inside the BHU directly into a stair landing. The stair landing had numerous hazards and ligature risks including but not limited to a ladder that extended from the floor to the ceiling, pipes of various sizes and metal support hardware attached near the ceiling, a thick pipe above a radiator or similar unit near a window, and extending up the wall, an "Evacuation" bag hanging by a strap on a wall mounted hook, a red metal "Med Sled" attached to the wall with a loopable area on it, and stairwell and stair railings that created ligature risks. The route proceeded down 4-5 flights of metal stairs that created the risk of accidentally or intentionally falling down the stairs. At the bottom of the stairs the route exited to a public area outside that was not enclosed or otherwise secured and proceeded up 3-4 stairs and around a corner to the secured "locked" outdoor area entry door. The outdoor area had numerous risks for harm to self or others including but not limited to large cement planters that could be hidden behind or jumped off of, picnic style tables with benches, other benches, and a double door with a loopable handle that created ligature risks, and various plants that created the risk of ingestion.

* On 10/07/2020 and 10/08/2020 in the BHU, patient sitting benches were observed in the hallways. The benches were within recessed areas in the hall and the length of the benches were wide enough to seat approximately four individuals on them. The space underneath the benches appeared large enough for an individual to crawl underneath the bench. The benches were observed from the hall at the nurse station area and on the video monitor with the MT. The space under the benches was not fully visible from the hall or the video monitor creating the risk that a patient could hide in those areas and harm themselves without being fully visible. This was confirmed by the MT and the BHU Manager at the time of the observation.

3. b. During an interview with the BHU Manager on 10/07/2020 at 1705, the BHU Manager stated a patient recently eloped from the BHU. The BHU Manager stated the patient was a "master" at elopement and followed a housekeeper out one of the exit doors. Refer to the findings cited at Tag A144 that reflects Patient 15 eloped from the BHU after he/she was allowed to follow an EVS staff out an exit door.

4. The P&P titled "Safety Measures for the Behavioral Health Unit (ARRMC)," dated effective 09/24/2020 reflected:
* "This policy details steps to maintain a safe environment on the Behavioral Health Unit (BHU) for patients, visitors and staff."
* " ... Sharps, such as scissors, knives, craft tools, etc., must be stored in a secured area not accessible to patients. These items as well as safety razors, may only be used under direct supervision of staff."
* " ... Ligature Risk: As much as possible, items in the environment that pose a ligature risk will be adapted or removed from the Behavioral Health Unit. These include, but are not limited to, shower and curtain rods, door handles, hardware and hooks, plumbing fixtures, lighting fixtures, fire sprinklers, fire system devices and bed cords..."
* " ... The charge nurse on each shift will assign one staff member to make safety rounds. Unless otherwise specified, this will occur during 'first rounds' of each shift and will include...Checking all patient areas and assessing for any potential safety hazards..."
* "Consider standby precautions with a second staff member when using the non-Sally port exit."
* "All staff should be aware of unit safety and if any potential safety hazards are identified should take measures to remedy them immediately."

The P&P reflected that the charge nurse would assign a staff member to make safety rounds, assess for potential safety hazards, and all staff should be aware of unit safety, and if any potential safety hazards were identified should take measures to remedy immediately. However, the P&P was not fully developed or implemented as it did not specify the measures that should be taken to remedy safety hazards if identified.

The P&P reflected that standby precautions with a second staff member should be considered when using the non-Sally port exit. However, the P&P was not fully developed as it did not specify the circumstances under which a second staff member should be used, including where the second staff member was to "standby" and any other responsibilities the second staff member may have, if applicable.

Refer to the findings above related to unsafe items in the areas outside the non-Sally port exit leading to the BHU outdoor area.

Refer to the findings cited at Tag A144 that reflects Patient 15 eloped from the BHU after he/she was allowed to follow an EVS staff out the NE exit door, a non-Sally port door.

5. Regarding the hospital's failure to conduct a physical environment risk assessment and mitigation plans on the BHU; and staff training related to physical environment risk assessment and mitigation, the following information was provided:

* An untitled document with the heading "Behavioral Health Unit September 2020" was provided in response to a request for the hospital's BHU environmental risk assessment and corrective actions. During interview and review of the document with the DQ on 10/08/2020 at 1640, he/she stated the document was designed for evaluating workplace violence concerns, and was not a physical environmental risk assessment.

* P&Ps provided in response to a request for P&Ps that addressed patient safety and patient care in a safe environment, including physical environment risk assessment and other P&Ps were reviewed and included the following:
- "Assaultive Behavior Screening and Management (ARRMC)," dated effective 05/01/2020;
- "Behavioral Health Services - Operational Plan (ARRMC)," dated effective 07/23/2020;
- "BHU Admission Safety Guidelines," dated effective 06/03/2020;
- "Camera Monitor-Behavioral Health Unit (ARRMC)," dated effective 08/03/2020;
- "Care and Support of the Patient Who Has Been Assaulted and/or Injured (ARRMC)," dated effective 04/20/2020;
- "Disposition of Patient Belongings (ARRMC)," dated effective 05/01/2020;
- "Elopement Precautions (ARRMC)," dated effective 01/17/2020;
- "Outdoor Area Policy (ARRMC)," dated effective 09/24/2020;
- "Provision of Patient Care - Operational Plan (ASANTE)," dated effective 08/05/2020;
- "Restraint and Seclusion (ASANTE)," dated effective 04/16/2020;
- "Safety Measures for the Behavioral Health Unit (ARRMC), dated effective 09/24/2020; and
- "Suiciden Prevention," dated effective 04/11/2019.
None of the P&Ps reflected a clear procedure that ensured completion of an environmental risk assessment and mitigation plans on the BHU.

* Review of a BHU staff orientation/training document titled "BHU Nurse Orientation Guide," dated 04/23/2020 reflected it lacked staff training related to actions that should be taken if risks were identified in the physical environment.

* During an interview with the DQ on 10/08/2020 at 1700 the DQ stated stated the hospital had not conducted a physical environmental risk assessment of the new BHU and staff had not been trained related to what to do if they identified a potential or actual physical environment safety risk in the BHU.

6. a. OAR 333-500-0045 (1 and (2) requires: "A hospital proposing to make alterations or additions to an existing facility or to construct a new facility shall, before commencing such alteration, addition or new construction, submit plans and specifications to the Division for preliminary inspection and approval or recommendations with respect to compliance with Division rules and compliance with National Fire Protection Association standards when the facility is also to be Medicare or Medicaid certified ... Submissions shall comply with OAR chapter 333, division 675."

6. b. OAR 333-675-0000(1) requires: "Any person proposing to make certain alterations or additions to an existing health care or residential care facility, or to construct new facilities must, before commencing such alteration, addition or new construction, submit plans and specifications to the Oregon Health Authority, Public Health Division, Facilities Planning and Safety, 800 NE Oregon Street, Suite 465, Portland, OR 97232 for plans approval or recommendations with respect to compliance with rules authorized by ORS 441.025, 443.420 and for compliance with National Fire Protection Association standards when the facility is also to be Medicare or Medicaid certified."

7. a. Review of state licensing records reflected an FPS "Project Substantial Completion Notice Form," dated 05/22/2020 regarding the new BHU. The form reflected "Please Note: Patients may not occupy the space until the following steps have been completed ... FPS completes an onsite inspection ...All deficiencies identified during inspection have been resolved ... FPS issues a final Notice of Project Approval; and ... All OHA Health Facility Licensing and Certification requirements or All DHS Safety, Oversight and Quality Unit requirements have been met."

7. b. Review of state licensing records reflected an FPS "Project Inspection Report" dated 06/04/2020 regarding the new BHU. The report reflected the unit was inspected by FPS on 06/02/2020, was occupied by patients at that time, a final project approval had not been issued by FPS, and numerous items, including ligature and other physical environment safety risks, were not in compliance with state licensing requirements. The report reflected:
* "This notice is intended to inform ... that the project ... has been inspected by Facilities Planning and Safety (FPS) to ensure compliance with physical environment rules issued by ... Oregon Health Authority Health Facility Licensing and Certification."
* The document reflected the following items were noted and/or required a written response before a final Notice of Project Approval would be issued:
- "333-535-0061(7)(c) Padding at outside column corner at Seclusion 3416 does not provide adequate cushion. Either provide a softer padded surface or chamfer corner to relieve acute angle and mitiga