OHSU Hospital and Clinics

“COMPLIANCE WITH LAWS CFR(s): 482.11 Compliance with Federal, State and Local Laws This Condition is not met as evidenced by: 44104 Based on observation, interviews, review of medical records of 3 of 13 alcove patients (Patients 16, 21, and 26), review of incident/grievance documentation for 5 of 13 patients (Patients 16, 21, 22, 26, and 27), review of policies and procedures, review of state licensing documents, and review of other documentation, it was determined that the hospital failed to fully develop and implement policies and procedures that ensured patients admitted as inpatients to alcove spaces were provided care in a safe physical environment that was in compliance with the state FPS (Facility Planning and Safety) and HFLC (Health Facility Licensing and Certification) licensing requirements. * Patients occupied alcove spaces on several units prior to a required FPS state licensing review, and final FPS and HFLC approval; and * Patient care equipment for monitoring, adequate space for safe care, furnishings, and other conditions identified during an onsite observation and through a review of medical records, grievances, and incidents revealed that patients were not provided a safe and therapeutic environment for care. 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 under Tag A- 0022, CFR 482.11(b) - Licensure of Hospital. Those findings reflect the hospital’s failure to ensure that the hospital was in compliance with state licensing requirements. 2. Refer to the findings cited under Tag A-700, 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 state licensing requirements.”

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 44104 Based on observations, interviews, review of medical records of 3 of 13 alcove patients (Patients 16, 21, and 26), review of 5 of 10 pediatric patients (Patients 1, 2, 3, 4, and 5), review of incident/grievance documentation for 5 of 13 patients (Patients 16, 21, 22, 26, and 27), review of policies and procedures, and review of other documentation, it was determined that the hospital failed to develop and enforce policies and procedures that ensured patients’ rights, such as the right to safe care, and a patient’s basic right to privacy, dignity and comfort, were provided in accordance with CMS regulations and hospital policies and procedures. Specifically: * The hospital failed to adequately assess whether patients placed in hallway alcove beds could be provided safe and appropriate care based on each individual patient’s needs. - The alcoves’ physical spaces on 9K and other hospital alcove areas prevented patients from freely exiting both sides of the gurney. Patients whose injuries were located opposite the wall where gurney egress was blocked had the potential for re-injury or increased pain while exiting the gurney on the same side as their injuries. - Some patients who had mobility and ROM issues were placed in alcove spaces where they needed to ambulate up to 90 feet to access a private bathroom, or reach across the opposite side of the gurney to access personal items or patient care supplies. - A patient with a potential for respiratory desaturation was placed in the 9K alcove space and the hospital did not have the capabilities to monitor a patient’s oxygen remotely in that area. - A patient with “bladder issues” was placed in a 9K alcove space and the nearest bathroom was 90 feet down a hallway. * The hospital failed to provide hallway alcove patients a safe, easily accessible, private bathroom that included a handwashing sink, a shower, a toilet, and other safety features. - Some hallway alcove patients had no access to a bathroom where they could conduct personal hygiene activities, such as toileting or bathing, and instead were provided bedpans and bedside commodes for use behind a curtain in a hallway used by staff, other patients, and patient visitors. - Not all bathroom facilities used by alcove patients were equipped with standard safety features such as emergency call lights, or doors that opened outward so as to prevent obstruction or blockage by a compromised patient. * The hospital failed to ensure that a patient’s reasonable expectation of privacy was met. - Hallway alcove gurneys were situated in high traffic areas, next to nursing stations and other patient rooms where conversations about hallway alcove patients, other patients, and nursing communications about patients could be overheard. - There were no doors preventing others from entering a patient’s private space, or that could be closed by the patient to prevent intrusion or provide additional security. - Curtains and privacy screens used to provide privacy in hallway alcove spaces did not sufficiently conceal the space and left patients exposed to passersby. * The hospital failed to ensure that patients, patient visitors, and/or patient support persons, were reasonably accommodated and afforded a comfortable, healing environment. - The 9K alcove space did not provide adequate space for a chair with ample room for visitors to sit comfortably and some chairs jutted out into the hallway. - Patient care items placed in the hallway alcove area resulted in crowded floor space, leaving the patient and patient visitors with little room to move around. The 9K alcove space had a two foot clearance between the bedside and the wall. - Alcove spaces had lights that were part of the hallway lighting system, so they could not be turned off or down by the patient. - Alcove hallway spaces were situated near high traffic areas such as storage rooms where staff regularly entered and exited, disturbing hallway patients with the repeated opening and closing of doors. * The hospital failed to document adequate training that ensured competency for medical personnel who administered vaccines to patients. 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 Tag A-0118, Patient Grievances and Incidents, observed breaches in patient safety, lack of infrastructure for certain types of monitoring, lack of sufficient space for patient care items, poor visitor experiences, lack of patient privacy, and the inaccessibility of bathrooms for patient use. 2. Refer to Tag A-0022, Licensure of a Hospital, a list of patient alcoves that had not been reviewed and approved for patient use by the state hospital licensing agency. Reflected in this tag: Measurements of walking distance from alcove gurneys to the nearest bathrooms, handwashing sinks, surveyor observations of limited space, and lack of equipment of the 9K alcove space. 3. Refer to Tag A-0144, Patient Rights, right to safe care, medical record reviews which reflected failures to follow physicians’ orders and Occupational Therapist observation of a patient inability to egress from one side of the bed, as well as failures to follow nationally recognized standards of care for safety, privacy, dignity, and comfort. 4. Refer to Tag A-1081, which reflected two separate, vaccine administration errors involving pediatric patients, with one incident affecting more than 100 patients. In October of 2023, 177 pediatric patients under the age of 12 years received up to twice the ordered dose of the Covid-19 vaccine which had been administered by Medical Assistant(s). In December of 2025, 19 pediatric patients under the age of 12 years were administered a Covid-19 vaccine that was Beyond the Use Date, contrary to hospital policy. These vaccines were also administered by Medical Assistant(s).”

“PHYSICAL ENVIRONMENT CFR(s): 482.41 The hospital must be constructed, arranged, and maintained to ensure the safety of the patient, and to provide facilities for diagnosis and treatment and for special hospital services appropriate to the needs of the community. This Condition is not met as evidenced by: 44104 Based on observation, interviews, review of medical records of 3 of 13 alcove patients (Patients 16, 21, and 26), review of incident/grievance documentation for 5 of 13 patients (Patients 16, 21, 22, 26, and 27), review of policies and procedures, review of state licensing documents, and review of other documentation, it was determined that the hospital failed to fully develop and implement policies and procedures that ensured patients admitted as inpatients to alcove spaces were provided care in a safe physical environment that was in compliance with state licensing requirements. * Patients occupied alcove spaces on several units prior to a required FPS (Facility Planning and Safety) state licensing review, and final FPS and HFLC (Health Facility Licensing and Certification) approval. * Patient care equipment for monitoring, adequate space for safe care, furnishings, and other conditions identified during an onsite observation and through a review of medical records, grievances, and incidents revealed that patients were not provided a safe and therapeutic environment for care. 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 under Tag A- 0022, CFR 482.11(b) - Licensure of Hospital. * Findings reflected the hospital’s failure to ensure that the hospital was in compliance with state licensing requirements. Alternative care spaces were not reviewed and approved by the State FPS section, or the HFLC department prior to admitting patients for care to those spaces. * Findings reflected the hospital’s failure to ensure patients received care in a safe physical environment. Patients were admitted into an environment that lacked infrastructure, square footage, fixtures, and equipment standard in patient care rooms. 2. Refer to Tag A-0144, Patient Rights, right to safe care. * Findings included observations and review of patient medical records that reflected the hospital admitted patients, and provided patient care, in hallway alcoves that lacked medical equipment, fixtures, standard furniture, and privacy needed for safe patient care.”

“LICENSURE OF HOSPITAL CFR(s): 482.11(b) The hospital must be - o Licensed; or o Approved as meeting standards for licensing established by the agency of the State or locality responsible for licensing hospitals. This Standard is not met as evidenced by: 44104 Based on observation, interviews, review of medical records of 3 of 13 alcove patients (Patients 16, 21, and 26), review of incident/grievance documentation for 5 of 13 patients (Patients 16, 21, 22, 26, and 27), review of policies and procedures, review of state licensing documents, and review of other documentation, it was determined that the hospital failed to fully develop and implement policies and procedures that ensured patients admitted as inpatients to alcove spaces were provided care in a safe physical environment that was in compliance with the state FPS (Facility Planning and Safety) and HFLC (Health Facility Licesning and Certification) licensing requirements. Specifically: * The hospital failed to ensure that a required FPS state licensing inspection, and final FPS approval had been obtained prior to admitting patients to hallway alcove spaces for patient care on seven hospital units; nine alternative patient care areas. * The hospital failed to ensure that the physical environment and needed infrastructure for safe patient care in hallway alcove spaces was provided. Hallway alcove spaces lacked standard hospital furnishings, fixtures, infrastructure, and adequate square footage required for the safe monitoring, movement, and care of patients that was consistent with State and CMS standards for patient care. Findings include: 1. A document titled, “2026.02 OHA Complaint Investigation ... unit list ...”compiled and provided by the hospital was reviewed and reflected: * The hospital listed seven units where alternative care spaces were being used for patient boarding and care. These units were: 9K, 10K, 11K, 12K, 13K, 14C, and 14K. Units 12K and 14K both had two alternative care spaces. Altogether, there were nine alternative care spaces in use at the time of the survey. * All of the listed patients were classified as inpatients, but a side note indicated they could be admitted as observation patients. * The listed patients could be admitted or transferred into these alternate care spaces via the “ED, Post Op (via PACU), [or as a] Direct Admit.” * None of the alternate care spaces listed had an attached, private bathroom. Instead, the hospital temporarily converted staff bathrooms into APBR (alcove patient bathrooms). Additionally, many of the fixtures normally present in patient care areas were not situated near the alternative care spaces. For example: - 9K: The APBR was 90 feet from the bedside, the door swung inward, there was no shower, and no emergency pull cord. The nearest handwashing sink was 25 feet away from the bedside. - 10K: The APBR was 41 feet from the bedside, the door swung inward, there was no shower, however, the APBR did have an emergency pull cord. The nearest handwashing sink was 8 feet away from the bedside. - 11K: The APBR was 41 feet from the bedside, the door swung inward, there was no shower, however, the APBR did have an emergency pull cord. The nearest handwashing sink was 8 feet away from the bedside. - 12K: (2 alternative care spaces) “N/A - pts. use bedside commode,” there was no shower or emergency pull cord because no bathrooms were available. The nearest handwashing sink was 23 feet away from the bedside. - 13K: The APBR was 57 feet from the bedside, the door swung inward, there was no shower, however, the APBR did have an emergency pull cord. The nearest handwashing sink was 4 feet away from the bedside. - 14C: The APBR was 56 feet from the bedside, the door swung inward, there was no shower, and no emergency pull cord. The nearest handwashing sink was 56 feet away from the bedside. - 14K: (2 alternative care spaces) The APBR was 56 feet from the bedside, the door swung inward, and the APBR did have an emergency pull cord. The nearest handwashing sink was 4 feet away from the bedside. There was no attached shower, “... however there is a separate, private, hallway shower that hallway bed patients may use.” 2.a. During an observation of unit 9K on 01/29/2026 at 0923, the following was observed: * The description of the 9K alcove in Finding 1 was observed by the surveyor to be an accurate description. * The alcove space and gurney, when viewed from the hallway, was observed by the surveyor, and: - The patient gurney was situated against the wall on the patient’s right side. This only allowed the patient to exit the gurney from the left side, unless the gurney was moved out of the alcove space. - There was ~ a two foot distance between the gurney and the left wall of the alcove. * A small metal table was situated in the back left-hand corner of the alcove and had three boxes of gloves and a portable sharps container on top. These items filled the top space and did not allow placement of other items, such as a patient’s personal items. The table had a drawer and a shelf underneath, which would be difficult to reach if a patient had left-sided injuries. * A red biohazard container on the floor did not have a lid and the privacy curtain was hanging down inside it. * There was not enough space for a visitor chair to be placed alongside the head of the gurney. A chair could be placed at the end of the gurney, however, if the privacy curtain was pulled closed, it would lay up against the visitor chair and the back of the visitor’s head. * Per the NM, the space had been converted from the unit pharmacist’s work station which had a built-in work counter and computer. 2.b. The description of the previous alcove space on 9K, as described in Patient 16’s grievance dated 01/18/2024, was confirmed by surveyor observation on 01/29/2026 at 1236, and the physical space was as described by Patient 16’s spouse. Refer to Tag A-0118, Finding 3.b. * The space was just wide enough for a gurney, and a gurney in that space would similarily be butted up against a wall, blocking egress from that side. A chair for visitors would not have fit in that space without either being in the hallway or at the foot of the patient’s gurney. * The previous alcove space was now converted into a storage area for portable vital machines, a rack for PPE, wheelchairs, and other patient care equipment. The hospital failed to provide a patient care space that met the safety and well-being of patients. The NM confirmed Findings 2.a. and 2.b. at the time of the unit tour. A change of use for each space, or waivers to use those spaces, had not been reviewed or approved by the State FPS department, or the State HFLC section. The DRA confirmed that the hospital did not have waivers for any of the inpatient hallway alcoves identified in Finding 1, including the alcove on unit 9K. 3. An email from the state FPS section to the surveyor dated “February 2, 2026” reflected that the FPS section had not reviewed the nine unit alcove spaces in use at OHSU. There were no change of use requests submitted for 9K for either the work station conversion to an alternative care space, or the conversion of the previous alternative care space to a storage area. There were no change of use requests submitted for any of the nine alcove spaces in use at the time of the survey. There were no waivers for any of the nine inpatient hallway alcoves. 4. Refer to Tag A-0118, Findings 3.b., 3.c., 3.d., and 5.b., that reflected patient grievances and incidents that described additional patient safety concerns for the alcove hallway spaces. 5. Refer to Tag A-144, review of patient medical records, which reflected examples of the hospital’s failure to ensure a safe physical environment for patients admitted to the alternative care spaces.”

“PATIENT RIGHTS: GRIEVANCES CFR(s): 482.13(a)(2) The hospital must establish a process for prompt resolution of patient grievances and must inform each patient whom to contact to file a grievance. This Standard is not met as evidenced by: 44104 Based on observations, interviews, review of incident and grievance documentation for 5 of 13 patients (Patients 16, 21, 22, 26, and 27), 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’ grievances and incidents were thoroughly investigated and documented in accordance with CMS regulations and hospital policies and procedures. Findings include: 1. A policy titled, “Patient Complaint and Grievance Management Process Policy” and dated 03/10/2022. It was reviewed and reflected: * “The purpose of this policy is to provide a uniform mechanism for managing all patient complaints and grievances regarding care and services received at Oregon Health & Science University’s Hospitals and Clinics (‘OHSU Healthcare’).” * “The Department of Patient Relations will acknowledge receipt of a grievance at OHSU within seven (7) business days and no longer than ten (10) calendar days.” * “Grievances will be managed within a reasonable time period as determined by the complexity of the grievance, and the investigation and decision-making required (normally within thirty (30) calendar days of receipt of the grievance).” * “If the grievance cannot be resolved within thirty (30) calendar days of receipt, written notice informing the grievant that the investigation is still ongoing will be sent with an anticipated timeframe for a response.” * “A grievance is considered resolved when the grievant is satisfied with the actions taken on their behalf or it has been determined that all appropriate and reasonable efforts have been made to appropriately address the stated concerns.” 2. The hospital’s current policy titled, “Patient Complaint and Grievance Management Process Policy” dated 01/07/2026 was reviewed and reflected: * “The purpose of this policy is to establish a uniform mechanism for the submission and management of patient complaints and grievances related to healthcare and services received at Oregon Health & Science University’s hospitals and clinics.” * “Acknowledging the Grievance ... The Department of Patient Relations will send a written acknowledgement of the grievance within seven business days, and no later than 10 calendar days after receiving it.” * “Timeframe for Resolution ... Most grievances will be resolved within 45 calendar days, depending on the issue’s complexity and the extent of the investigation required ... If we cannot resolve the grievance within 45 days, we will send the patient or their representative a written extension letter. This letter will explain that more time is needed and that the additional review may take up to 45 more days, although the issue may be resolved sooner if possible.” * “When a Grievance Is Considered Resolved ... A grievance is considered resolved when ... The person who filed it is satisfied with the outcome, or ... OHSU has made all appropriate and reasonable efforts to address the concern.” 3.a. During a grievance and incident review with 01/29/2026, beginning at 1145 with the VPPE, the DPA, the PS and others, grievance documentation for patients 16, 21 and 22 reflected: 3.b. Grievance documentation for Patient 16 noted: * “Entered Date: 01-18-2024.” * “Type of Person Affected ... In-Patient.” * “Date of Notification 01-18-2024.” * “Desired Outcome ... Change in Process/Procedure ... Event Does Not Happen Again ... Improved Care for Patient/Others” * “Description ... Complaint regarding pt. being put into an alcove hallway bed on 9K.” * “What is this issue about? Location.” * “Location 9K Orthopedics/Spine ... Clinical Specialty Orthopedics.” * “Feedback Categories ... Accommodation ... Availability of requested room ... Comfort of accommodation for family/friends ... Noise - on unit ... Phone availability ... Care/Treatment ... Quality of care.” * An undated letter from Patient 16’s spouse was attached to the grievance documentation. It reflected that Patient 16 was charged for a “room” but was placed in a “A slightly wider space in the hall; it is not a room ... just wide enough for a gurney; not wide enough for a hospital bed. Spending the night on a gurney rather than a bed meant that there was no bed mounted call bell ...” The grievance letter described several safety and patient care concerns which included: a.) “... [Patient 16] could not easily/safely get in and out of the gurney as it is higher than a hospital bed and [they are] about 5’ tall.” (The height of the gurney was confirmed by surveyor observation during the unit tour and via NM interview.) b.) “the bedside tray could not be positioned to extend over the bed as the base would no [sic] go under the gurney.” c.) “It is a space with two overhead lights but no switch to control those lights. Thus, [Patient 16’s] choice was to have the lights always off or always on or someone climbing over the gurney to screw in the light bulbs that had been loosened so they were not always on in the patient’s face.” (This allegation was confirmed by surveyor observation of the space during the unit tour.) d.) “The “alcove” had a red, contaminated waste container. It was sitting on a metal stand at eye level to the patient. It could not be operated by foot as the design intends instead, to be used, it would have to be opened by hand.” e.) “It is a space with no privacy, either visual or sound. The metal framed and fabric covered privacy screens were not big enough to actually provide privacy - if they were blocking the view from one direction, they were open at the other end ... effort was made by staff and [Patient 16’s spouse] to try to get to an acceptable arrangement, and it was just not possible.” f.) “ ... every noise in the hallway was heard by [Patient 16] with no buffer at all.” (This allegation was confirmed at the time of the unit observation by interview with the NM.) g.) “[The] space [was] about 3 feet from a door to a storage room with a heavy, locked door that the staff went in frequently and that banged shut every time.” (The allegation was confirmed by surveyor observation at the time of the unit tour and by interview with the NM.) h.) “In the other direction, the ‘alcove’ is about 3 feet from a hallway nurses’ station with computer monitors. Not surprisingly, when the staff worked at that station, they conversed with their colleagues, talked on their phones, and used the speakers on their communication devices. This is obviously inconsistent with the atmosphere one expects for a patient’s ‘room’.” (This allegation was confirmed by surveyor observation at the time of the unit tour and by interview with the NM.) i.) “The ‘alcove’ is a space with no ... medical equipment such as an oxygen panel or suction or communications. [Patient 16] was on oxygen and it was in a roll in canister parked alongside the gurney in the hallway - it wouldn’t fit into the alcove because the entire space was taken up by the gurney. Also in the hallway adjacent to the alcove was an IV stand and the privacy panels mentioned above, and the bedside tray that would not go under the gurney and a chair for [Patient 16’s spouse.]. When staff were at the gurney providing care, the hallway was roughly half blocked.” (This allegation was confirmed by surveyor observation of the alcove space at the time of the unit tour.) j.) “[The] gurney was not equipped with a call button. [There was] ... a bell like ... on the reception desk ... and ... a circular transmitter about 2 inches in diameter that was labeled ... Because the gurney took up all the room, and the bedside tray could not sit by the gurney, neither of these call tools were within reach ... They sat on a metal stand at the end of the gurney alongside the red, contaminated waste container - completely out of reach.” k.) “... the ‘alcove’ is a place where there is ... no space ... for a patient’s personal belongings, and no place other than the hallway for visitors.” (This allegation was confirmed by surveyor observation at the time of the unit tour.) l.) The letter listed privacy concerns with the alcove space lacking a bathroom, and the ability to hear other patient information as well as conversations occurring in other patient rooms, nursing stations and the hallway. * “Grievance Acknowledgement Letter Sent ... 01-18-2024.” * “Work done on file ... Description ... “ This section of the form contained approximately 17 interdepartmental emails beginning on 01/18/2024 at 1417 through 01/29/2024 at 1343. None of the 17 emails addressed the patient care concerns as described by the patient’s spouse in the grievance letter above and instead focused on billing concerns. Additionally, on 01/19/2024 at 1135, the writer stated, “I got this yesterday and will need to respond within 30 days ... “ * The resolution letter attached was dated “March 19, 2024,” 50 days after the last internal communication email was sent, and 60 days after the hospital first received Patient 16’s grievance. The resolution letter addressed billing concerns and minimally alluded to quality of care or safety concerns. For example, the letter reflected: - “Steps taken to investigate your grievance: Your concerns were sent to the OHSU Quality of Care committee, the director of bed placement, and the managers of the 9K unit.” - “Results of the grievance investigation process: One of the managers of 9K said they had spoken to you about this issue so they were aware that this was a disappointing experience. Between bed placement, 9K leadership and the Quality of care review there was much discussion about making patients aware of these kinds of hallway bed placements. The OHSU Emergency Department does have a handout that they give to patients when they are going to be placed in such a bed. It came to this group’s attention that the post-surgical area does not have such a handout to give to patients or families. The post-surgical area has been made aware of these handouts to give to patients and/or families. I have included this handout in the attachments ... After the review, the quality of care was determined to be appropriate and there will not be a waiver of the bill for [Patient 16] being placed in a hallway bed on 9K. We apologize that neither of you were given the handout about the hallway placement for your awareness. The postoperative area is now handing out this information.” - “Date of Resolution and hospital contact: As of the date of this letter, we consider this grievance resolved.” * On 03/22/2024, Patient 16 and their spouse responded to the resolution letter via email, and stated, “[We] want to let OHSU know that we found the response to our complaint totally unsatisfactory. Surely handing us a piece of paper would not have addressed any of the failures noted in our original complaint.” * Under “Resolution and Outcomes” were three areas for notes. They were “Allegations Substantiated? ... Resolution Summary ... [and] Outcome Notes.” There was nothing written in any of these areas. The hospital failed to adequately address the quality of care and patient safety concerns that were submitted to the hospital by Patient 16’s spouse. For example, the hospital’s internal communication and documentation did not reflect that a discussion regarding privacy, toileting, lighting, or patient comfort concerns as described in the grievance had occurred. The emails and other documentation did not reflect discussion or investigation into the bed height and safe egress for a 5’ patient, or safety concerns with the call light placed out of patient reach. There was no noted discussion about infection prevention concerns regarding the biohazardous waste container or the lack of a patient bathroom. Additionally, the hospital failed to adhere to its policy, and did not send the resolution letter within the 30 day time frame. There was no evidence that when the 30 day time frame had expired, the hospital sent a letter to the complainant to inform the grievant that the investigation would be ongoing. In fact, the hospital delayed sending the resolution letter for 50 days, almost two months after the internal investigation and discussion had concluded. Although the hospital received a letter from the patient and their spouse that they had been dissatisfied with the resolution, the hospital failed to document whether they had “made all appropriate and reasonable efforts to address the concern.” 3.c. Incident documentation for Patient 21 noted: * On 12/07/2023 at 1601, a physician order to monitor Patient 21, who had “a witnessed respiratory desaturation or obstruction,” was not able to be implemented because the hospital lacked the infrastructure to comply with the order for a patient placed in the 9K hallway alcove. Refer also to Tag A-0144, Finding 5.c., Patient 21’s medical record review, physician orders and RN communication. * Incident reporting documentation reflected: * “Reporter Role: Registered Nurse.” * “Event Type ... Equipment.” * “Event Category ... Equipment Unavailable.” * “Event discovery date [sic] ... 12/07/2023.” * “Event discovery time [sic] ... 0730.” * “Event Occurrence Date ... 12/07/2023.” * “Event Occurrence Time ... 02:00.[sic]” * “Category ... Patient.” * “Primary Location/Service Name ... 9K ... Ortho.” * “Describe the event ... Pt was brought to the floor to be in the alcove bed, remote pulse oximetry ordered. pt [sic] requiring 4L [oxygen]. once [sic] the pt arrived informed that they could not be on remote pusle [sic] oximetry unless they were in a bed. No beds available, so pt was not able to be monitored.” * “Describe any contributing factors ... or recommendations ... lack of understanding of where the tele monitors can be used, could benefit on my education so a situation like this doesn’t occur again.” * “Mgr Review: Deviation from generally accepted practice standards? ... No.” * “What was the remedy or corrective action plan to reduce the likelihood for its recurrence? ... No action recommended at this time.” * “How preventable was the incident? ... Likely could NOT have been prevented “ The hospital failed to fully investigate whether the alternative care space was appropriate for a post-operative patient who was on 4L of oxygen and who required additional monitoring per physician’s order. Patient 21 was placed in an alternative care space, and the hospital lacked the infrastructure to provide remote monitoring for a noted respiratory concern, refer to Tag A-144, Finding 5.c., Patient 21’s medical chart review. There were no notes about whether the hospital policies had been reviewed or at what “Tier” the patient had been assessed prior to the 9K alcove placement. The investigation lacked clear documentation that recommended actions, such as “education” had occurred to prevent recurrence. The manager review noted there was no deviation from generally accepted standards, so it was unclear whether patients with ordered pulse oximetry monitoring were regularly placed in an area where monitoring could not occur. 3.d. Incident documentation for Patient 22 noted: * On 01/30/2024 at 1900 during a change of shift, Patient 22 was transferred from PACU into an alcove bed on 9K. * “Reporter Role: Charge Nurse.” * “[Patient] Subtype ... Outpatient.” * “Event Type ... Care Coordination/Communication.” * “Event Subcategory ... Bed not Available.” * “Primary Location/Service Name ... 9K ... Ortho.” * “Event Detail ... Patient arrived at shift change from PACU and was assigned for hallway bed. Patient arrived to unit and was very upset about not being told and having to be placed in a hallway bed fresh after surgery. Patient had not been out of bed yet, had not voided and had a [Peripheral Nerve Block] running. Explained situation of all beds being full and patient preferred to DC then [sic] stay in hallway bed for the night. Called patient placement for permission to move patient into room we had just had opened up but unable to do so due to other patient needing to go there. Discussed with patient again about lack of beds and patient again stated they will go home if no rooms available by midnight. Assistant manager notified by charge RN and suggested contacting AOD [Administrator on Duty]. AOD notified along with patient placement again who were able to find patient a bed in a shared room on another unit. Patient notified and OK with this. Was getting ready to send patient to other unit and patient placement notified that patient had not had a covid test done since arrival to hospital. Rapid covid done. Patient was placed in hallway bed without updated covid test.” * “Describe any contributing factors ... or recommendations ... Patient not being aware of being placed in hallway bed led to a disruption in care and used resources ... having a fresh post-op patient going into a hallway bed is unsafe. Patient had not been out of bed and had not been able to mobilize. Would have had to use the bathroom by using the bedpan which would then cause staff to carry a used badpan [sic] down the hallway to the available bathroom.” * “Mgr Review: Deviation from generally accepted practice standards? ... No.” * “What was the remedy or corrective action plan to reduce the likelihood for its recurrence? ... No action recommended at this time.” * “How preventable was the incident?” [This was left blank.] * “Notes ... Able to get the patient to an appropriate room prior to placement but it caused extra stress on the staff/patient. This is a newer process of having hallway beds so it continues to evolve and we are learning along the way.” The hospital failed to fully investigate whether the alternative care space was appropriate for a post-operative patient who had not had a negative Covid-19 test in accordance with hospital policy, and who had not yet ambulated, refer to Tag A-144, Finding 3, the hospital policy for use of alternative care spaces. The hospital placed Patient 22 in a hallway alcove space that required the non-ambulating patient to ambulate a distance of 90 feet to the nearest bathroom, refer to Tag A-0022, Finding 1, the hospital’s description of the 9K alcove space whose patient bathroom was approximately 90 feet from the patient’s bedside. There were no notes about whether the hospital policies had been reviewed or at what “Tier” the patient had been assessed prior to the 9K alcove placement. There were no notes about whether any follow up education was provided to prevent recurrence. It was unclear whether the patient was admitted into a hospital room or remained in the hallway alcove. 4.a. During a review of Patient 26’s grievance on 04/13/2026 beginning at 1230 with the VPPE, the DPA, the NM, and others, the following information was provided: * On 10/23/2025, documentation regarding Patient 26 noted, “Pt would like to file a complaint regarding the conditions [they] were housed [in] during last admission.” * An embedded physician note described, “The patient expresses ... Discontent with being in a hallway bed as it [this was cut off in the document] and exposed.” * The physician’s note reflected that patient wished to leave the hospital AMA (Against Medical Advice). * Follow up notes reflected, “... spoke with patient who shared [their] intention to submit [their] concerns to OHA ... explained in that case, because an [investigation would be] completed through OHA, [patient relations] would not also complete an investigation but would be happy to do so on [their] behalf ... closed case.” The hospital failed to fully develop and implement their policy on grievances. The hospital stated to Patient 26 that they would not investigate their complaint, which was not in accordance with CMS requirements, or hospital policy, refer to Finding 1, the hospital’s grievance policy. The hospital failed to investigate a patient grievance, did not respond to the patient in writing within 7 days, and did not send a resolution letter within 30 days, in accordance with their policy. 4.b. During the grievance review, the VPPE confirmed Finding 4.a. and stated, “We filed it as a complaint. We would have filed [it] as a grievance but the patient wanted OHA to investigate.” The VPPE stated that because the “patient decided” not to file it with OHSU, the hospital classified it as a complaint and not a grievance. The VPPE also stated based on their understanding that the patient did not want the hospital to conduct an investigation, it was a complaint and not a grievance; therefore, the required follow through and resolution for grievances did not occur. 5.a. A fourth complaint, Patient 27, was triaged by the SA on 04/16/2026, processed for investigation and added to this survey on 04/20/2026. Grievance documentation provided by the hospital was reviewed. 5.b. Grievance documentation for Patient 27 noted: * “Entered Date: 12-11-2025.” * “Type of Person Affected ... Inpatient.” * “Date of Notification 01-18-2024.” * “Desired Outcome ... Clarification/Explanation ... Corrective Action ... Event Does Not Happen Again ... Improved Care for Patient/Others” * “Description ... Formal Grievance Regarding Substandard, Unsafe ... Care in ED.” * “What is this issue about? Location.” * “Location ... 11 KP” * “Feedback Categories ... Patient Relations ... Quality of Care ... Capacity Contstraint.” * A “Grievance Acknowledgment Letter” was sent to Patient 27 on 12/11/2025. * Notes by the 11 KP NM indicated that the NM addressed the patient concerns with room availability, quiet hours signs, nurse staffing, patient advocacy by staff, patient safety issues (locked out of units), and delayed discharge. However, other concerns raised by the patient such as privacy, patient care equipment, or clutter in a “cubby” space were not addressed. * The patient’s concern with unregulated heating was addressed as an “air flow” isssue and there were no notes that the facilities department had been contacted, or whether there was an ability to regulate heat in the 11K alternative care space. Refer to Finding 5.c. below regarding Patient 27 being “hot” and “sweating” due to the physical environment. * On 01/12/2026, a grievance resolution letter was sent to the patient. The hospital failed to thoroughly investigate Patient 27’s concern with the physical environment, such as following up with the hospitals facilities department regarding regulation of temperature in the alternative care space. 5.c. A grievance letter submitted by Patient 27 to the hospital on 12/10/2025 noted admission dates from 11/07/2025 through 11/10/2025. It was reviewed and reflected: * Patient 27 noted they were admitted to the hospital on 11/07/2025 due to “a heart attack and hypertensive crisis.” * Patient 27 was admitted to 11K and “was placed in a makeshift hallway-adjacent cubby enclosed only by a curtain,” and it was not private, not therapeutic, “hot and poorly ventilated ... Directly next to activity noise echoing throughout and staff conversations all night ... Not a patient room, yet used as one.” * “I was placed in one of the most untherapeutic spaces with no wall suction, no oxygen, no privacy, minimal supplies, not even a guest chair, etc. The density of clutter that was attempted to be placed in this tiny space made it virtually impossible to move about - it was as though I was shoved in a storage corner of the unit.” * “I was awakened 7+ times each night by ... Loud staff conversations directly outside my cubby ... Equipment noise ... Staff entering the space.” * “I had to wear ... Ear plugs ... Face mask ... Sleep medications.” * “... due to the manner of my makeshift hallway setup, there was virtually no way to provide a therapeutic environment. Rather, my environment was chaotic, loud, and unsafe, and directly counter to cardiac recovery needs.” * Patient 27 was “Locked out on the 9th-floor terrace.” Patient 27 noted that due to “the lack of appropriate ventilation, being miserably hot, and persistently sweating from the heat on 11K ... where my hallway cubby was setup - I begged the staff to fix the heat, and/or turn on some air. I was literally close to faint [sic] it was so hot. Every staff who provided direct bedside care commented how hot it was in this corner, and some even removed a layer of their own clothing just to be at my bedside delivering care ... It was so hot in fact, I ... walked to the 9th floor terrace upon the recommendation from a ... nurse ... they unhooked my cords and set me up to push my IV pole and carry my telemetry monitor with me ... I went to the 9th floor terrace, only to have the door lock behind me with no means to re-enter the building ... I was ... locked outside in the dark cold weather ... The signage indicated the terrace was open ... The door locked behind me ... I was stuck outside pushing an IV pole with a heparin infusion ... I had to bang on the windows until someone realized I was trapped.” * Patient 27 was locked out a second time and described, “Locked inside the 11K therapy/rehab room - I needed to make essential communication calls to my family, and yet I had no privacy to do so being that I was assigned to a hallway cubby with only a curtain ... I stepped inside for privacy to make a phone call because I had none in the hallway ... When the door closed behind me, there was no doorknob ... I was trapped and had to pound loudly on the door ... It took several minutes before a nurse heard me and let me out.” Patient 27 reflected, “Both events represent alarming safety failures and environmental hazards.” 5.d. The resolution letter sent on 01/12/2026 to Patient 27 was reviewed and reflected: * The letter addressed several of Patient 27’s concerns regarding medical decison making, noise, nursing staff and assessments, requests to move rooms, unity safety and therapy room, and a delayed discharge. * Patient 27’s concern about “Placement in a Hallway Space” was addressed as: “Due to high hospital census, a room was not available and the empty room you saw was held for a patient who needed ICU level care. During times of high census, we use hospital hallway care spaces based on patient care needs and available rooms ... The Charge Nurse explained this to you and worked to improve your comfort by helping with airflow and access to a shower.” * The hospital did not address the lack of patient care equipment such as “no wall suction, no oxygen ... [no] guest chair ... [and] the density of clutter.” * The hospital did not address the privacy concerns of Patient 27. Specifically, the ability to make a phone call in privacy. * The hospital did not address the lack of a chair for visitors or the inadequate square footage of the alcove space on 11K.”

“PATIENT RIGHTS: PERSONAL PRIVACY CFR(s): 482.13(c)(1) The patient has the right to personal privacy. This Standard is not met as evidenced by: 44104 Based on observations, interviews, grievance and incident documentation reviewed for 2 of 13 patients (Patients 16 and 27), 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 a patient’s right to privacy was recognized, protected and promoted. Findings include: 1. Refer to Tag A-0022, Licensure of a Hospital, that contains a detailed list and description of nine alternative care spaces used by the hospital for inpatient care. The spaces lacked an attached, private bathroom for patient personal care and toileting needs. Some patients were provided bedpans and bedside commodes to use behind a curtain in a hallway where other patients, staff, and visitors would pass by. 2. Refer to Tag A-118, Grievances, detailing patient concerns with a lack of privacy, as well as concerns with privacy screens and curtains that did not safeguard a patient’s right to privacy due to inadequate size/coverage. 3. Refer to Tag A-144, Patient Rights, Finding 1, the patient handout for shared spaces, and Finding 3, the hospital’s alternative care policy which references hallway alternative care spaces, privacy screens and no overnight visitors.”

“PATIENT RIGHTS: CARE IN SAFE SETTING CFR(s): 482.13(c)(2) The patient has the right to receive care in a safe setting. This Standard is not met as evidenced by: 44104 Based on observations, interviews, review of medical records for 3 of 13 alcove patients (Patients 16, 21, and 26), and 5 of 10 pediatric patients (Patients 1, 2, 3, 4, and 5), review of incident/grievance and investigation documentation reviewed for 5 of 13 patients (Patients 16, 21, 22, 26, and 27), review of policies and procedures, review of state licensing documents, 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, were provided care in a safe physical environment, and failed to ensure patients’ rights were recognized, protected and promoted as follows: * The hospital admitted patients, and provided patient care, in hallway alcoves that had not been reviewed and approved by the state FPS and HFLC sections. * The hospital provided patient care in areas of the hospital that lacked medical equipment, fixtures, standard furniture, and privacy needed for safe patient care. * The hospital failed to document adequate training that ensured competency for medical personnel who administered vaccines to patients. Findings include: 1. A patient handout titled, “Patient care during a surge ... What to expect for the best comfort and care” dated “12/19/2022” was reviewed and reflected: * “Some areas of our hospital often have more patients than we can care for in the spaces we normally do. To make room for all patients, at times we might need to use overflow areas and shared spaces.” * “You might not get a room ... you could go to a curtained space with other people or be treated in a large part of a hallway. We will still do everything we can to respect your privacy.” * “We want you to be as comfortable as possible. Here are some comfort tips for shared patient spaces ... Use ear plugs to help reduce noise while you rest ... When using the phone or talking to visitors, try to use a calm and quiet tone ... Set your cellphone to vibrate or silence mode ... Ask your care team for help with using the bathroom or if you have personal hygiene needs such as bathing, washing your hands, brushing your teeth, and more.” 2. An updated patient handout titled, “Patient care in shared spaces What to expect for the best comfort and care” dated 05/15/2023” was reviewed and reflected the same information as Finding 1 above. 3. The policy titled, “Alternative Care Spaces During Capacity Constraints Procedure” with an origination date of “05/31/23,” was reviewed and reflected: * “Purpose: Provide structure and processes around the placement of inpatients in alternative care spaces during times of capacity constraints, including both admitted and discharging patients.” * “Definitions: Regular beds: All licensed inpatient beds ... Alternative Care Spaces: Beds that can flex into a space when needed, such as hallway and other overflow spaces.” * “Key Words: Overflow ... patient placement, hallway space, alcove space, alternative care spaces.” * “Unit Criteria/Surge Escalation: Fill, or plan to fill, all inpatient beds prior to filling alternative care spaces. Plan to fill all lower tier beds before filling higher tier beds ... Alternative Care Spaces on Inpatient Units.” * “Tier 1 ...10K ... 11K ... 13K ... 10D infusion ... 14K treatment room ... 12K (2) ... 14C East Hallway.” * “Tier 2 Priority (red) ... 9K alcove ... 10K alcove ... 11K alcove ... 13K alcove ... 14K alcove.” * “Tier 3 Priority (dark red) ... No additional beds, see additional criteria.” * “Patient Criteria: The following criteria must be met for a patient to be bedded to an alternative care space located in the hallway ... Tier 1 - Most Appropriate ... Patient on unit who is possible home discharge within 12 hours should be first to be slotted to alternative care space ... Less than 4 L oxygen ... Patient can ambulate to the bathroom independently or has a urinary catheter ... Tier 2 - Next Appropriate ... Restrained patient ... Unable to ambulate ... Incontinent ... Confused patients ... Fall risk requiring sitter ... Tier 3 - Least appropriate ... Patient requiring private room or transmission-based precautions (excludes solid organ transplant patients) ... Patient in respiratory distress.” * “Unit Placement and Equipment ... Hallway which does not block egress pathway or exit ... All patients in alternative care spaces must have ... A negative clinical screen for COVID-19 (exposure and symptoms) ... A covid antigen test that results as not detected prior to placement ... At 72-hours repeat COVID-19 PCR test which result as not detected to stay in overflow space ... Patients who are post-op or have intermittent oximetry orders shall be on a portable oximeter ... Patient shall be provided with a bell, overbed table, privacy screen ... Portable O2 tank for patients on oxygen ... Trash receptacle, sharps container, hand hygiene station, gloves, disinfection wipes, and hamper.” * “Patient Care ... If a patient needs to use the restroom, or a urinal or bedpan needs to be emptied, use the nearest staff bathroom.” * “Visitation ... No overnight visitors ... Visitation will be limited to one visitor at a time due to space constraints. One support person will also be allowed to be present with a patient with a disability, in addition to one visitor.” The policy failed to clearly identify which patients were appropriate for placement in an alternative care space such as a hallway alcove. The policy used words such as “Most Appropriate ... Next Appropriate ... Least Appropriate” and did not clearly define the criteria required for safe placement in a hallway alcove bed. For example, it was not clear whether patients in respiratory distress, on 4L of oxygen, or who did not have a recent negative Covid-19 test could be safely cared for in a hallway alcove bed, an area that did not contain patient care equipment normally found in a standard hospital room. For example, Patient 21, refer to Finding 5.c, was on 4L of oxygen and required additional respiratory monitoring while in the 9K alcove. However, the space lacked the capabilities to provide that monitoring, and the inability to monitor such patients was not addressed in the policy. The policy did not clearly address the physical limitations of the hallway alcove beds or how those limitations affected patient care. For example, Patient 26, refer to Finding 5.d, had sustained injuries to their left ribs, however, due to the placement of the alcove gurney, the patient could not exit their bed to their right, as a wall blocked their egress, causing them to consistently roll onto their injured left side to exit the gurney. Refer also to Tag A-0118, Patient Grievances, Findings 3.b, 3.c., and 3.d. These findings included details about the inadequate space provided for patient care equipment to be conveniently accessible to the patient and their visitors, the lack of privacy, distance of bathrooms, and examples of the hospital’s failures to adequately assess whether patients with physical challenges were appropriate for admittance into an “alternative care space.” 4. A policy titled, “Placement of Adult Overflow Patients” dated 04/10/2023 was provided in response to the placement of patients in inpatient alcove beds. It was reviewed and reflected that the policy provided instruction and guidance for patients on the following units: 6A, 11B, 11C, and the MBU. Additionally there was mention of patient beds in the following designated observation areas: 5B, 6B, and 8D. Specifically the policy noted: * “Persons Affected: All OHSU healthcare members that are involved in placement of and care of patients in overflow areas. As part of the surge capacity management, it may be possible to see overflow patients in the following locations ... 6A - Bay Beds ... 11C ... 4 bay bed [sic] ... 11B (PCU) Walled rooms ... MBU.” * Definitions ... Inpatient status: A patient who has been admitted to a hospital bed occupancy to receive inpatient hospital services ... A patient is considered an inpatient if he/she is formally admitted as an Inpatient with the expectation that he/she will require hospital care that spans at least two midnights ... Observation status: The Provider has determined that the patient needs ongoing short-term treatment, assessment, and reassessment before a decision can be made regarding whether the patient will require further treatment as a hospital inpatient or are able to be discharged. Observation status should not exceed a 48-hour duration.” * “Key Words ... Overflow, OF, 6A PCU, 11BOF, 11COF, MBU overflow, Surge capacity, patient placement.” It was unlcear whether patients admitted to 9K and 11K alcove beds would fall under this policy, however, this was the policy provided by the hospital in response to a request for policies and protocols that guided use of the alternative care spaces. 5.a. During a medical records review with the PS, the NM, the RAM and others on 01/28/2026 beginning at 1345, the following information was provided: 5.b. Patient 16 was admitted to the 9K alcove inpatient bed postoperatively on 01/05/2024 at 1527 and discharged on 01/06/2024 at 1324. Patient 16’s medical records reflected: * Patient 16 was admitted for a “planned left rTSA” (left reverse Total Shoulder Arthroplasty), and had a history of “desaturation after R IS nerve block/catheter in 2021 for R reverse shoulder arthroplasty ... [patient] did not notice any SOB, but desaturated and required supplemental oxygen and unexpected overnight admission ... is planning to stay overnight after procedure.” * Patient 16 was listed as a “Daypatient,” however, grievance documentation entered by hospital staff into the hospital’s electronic database listed Patient 16 as an “In-patient.” Refer to Tag A-0118, Finding 3.b., Patient 16’s grievance. * An MD note dated 01/05/2024 at 1454 noted: “Post op check ... Breathing well, tentatively plans to stay the night due to respiratory concerns after shoulder replacement ... Special Concerns: staying overnight to monitor respiratory status.” * A nursing note on 01/05/2029 2310 noted: “frustrated with being in the hallway bed.” * A nursing note on 01/06/2024 at 0219 reflected: “frustrated with being in the hallway bed, movements and other pts TVs keeping her awake.” 5.c. Patient 21 was admitted to the 9K alcove inpatient bed postoperatively on 12/7/2023 at 0053 and discharged on 12/7/2023 at 1408. Patient 21 had post-operative orders for oxygen monitoring via telemetry, which the hospital could not provide while Patient 21 was boarded on the 9K unit in the alcove hallway. Patient 21’s medical records reflected: * An MD note electronically signed on “12/06/23 1326” reflected: “Chief complaint/Reason for admission ... pt is here for surgery of ... shoulder fracture.” * A post-operative MD order on “12/06/23 2345” reflected: “Remote Monitoring of Pulse Oximetry by Telemetry ... Authorized by: [Physician Name], MD” with a “Frequency [of] Routine Continuous ... [in-patient] Hospital ... Reason 12 hour [sic] monitoring for patients who have a witnessed respiratory desaturation or obstruction.” The order was “auto-released” by an RN on “12/6/2023 11:39 PM,” 74 minutes prior to being admitted to the 9K alcove bed. * An RN Care Plan note on “12/07/23 0106” reflected, “Problem Identified ... respiratory compromise ... Outcome ... Physiologic Homeostasis ongoing, progressing; adequate for care transition O2 @ 4L NC, sats 94-97% w/ brief 10s desats [sic] to 87% ... MD eval’d [sic], OK for transfer to floor on remote pulse ox; surgical team aware.” * A second RN post-operative Care Plan note on “12/07/23 0106” reflected, “Outcome Evaluation ... VSS on 4L NC remote pulse ox ordered tonight for 10s-long self-correcting desats [sic] to 87%, returns to 96% thereafter & denies SOB ... Outcome Anesthesia/Sedation Recovery progressing toward baseline; criteria met for transfer.” * An RN note on “12/07/23 0219” reflected, “Communication ... Support Notified ... MD/DO/NP/PA ... pt ordered to be on remote pulse ox, telemetry told me that pt cannot be monitored from the alcove. Pt not on IV pain med right now, wondering if you want to keep order ...” There was no follow up response noted either from the MD or the RN. * An RN note on “12/07/23 0703” reflected, “VSS, on 4 L NC overnight, AOx4 ... [Patient] was able to ambulate in the hallway and void in the toilet. [They] probably could be ad lib, we used a walker to be safe post surgery sedation. Pt’s [sibling] is at the bedside and has been very helpful in [their] care and advocating the pt’s needs. Mobility/Precautions: SBA w/ FWW.” * A post-operative MD note electronically signed on “12/07/23 0804” reflected: “Complexity note ... the care of this patient is far more difficult than a standard scapular fracture malunion. The patient has complicated care needs affecting the pre-, intra- and post- operative phases of care. The patient has sustained a complex intra articular scapula fracture that is almost 1 month out from ... injury and has a fracture with involvement and displacement of a significant portion of the glenoid. Due to the complexity of the problem was referred to my care at OHSU by another orthopaedic surgeon. The patient traveled to get to OHSU, bypassing several other hospitals and orthopaedic surgeons due to the complexity of injury and need for specialized care ... During surgery we required a longer incision than normal to achieve reduction, debride fracture and place hardware in appropriate position. The deformity made treatment, reduction, and certainly placement of implants more difficult as well. The surgery resulted in a higher blood loss ... with an extraneous surgical approach. This adds to the risk of complications postoperatively. The longer incison [sic] also took longer to close. The patient has limited mobility postoperatively making postop care more difficult to render. [Patient] will also require additional postoperative consultation and management. Please reflect all of this in the nature of the patients care.” * An OT note on “12/07/23 0850” reflected, “... fatigue from minimal overnight rest (patient in hallway alcove room) ... Recommend performing mobility check before mobilization for possible change in status and use of additional assist/lift if needed ... patient up ab lib to bathroom, overnight, with [sibling’s] supervision ... Additional Information Subjective: ‘I slept maybe 15 minutes at a time’ ... IADLs: assist from [sibling] ... Standing dynamic: supervision.” * An MD order on “12/08/23 1044” reflected, “Remote Monitoring of Pulse Oximetry by Telemetry (Discontinued) Electronically signed by: [Physician Name], MD ... Status: Discontinued.” The remote monitoring of Patient 21’s pulse oximetry by telemetry was discontinued after the Patient 21’s discharge on 02/07/2023 at 1408. 5.d. During a medical records review on 04/13/2026 beginning at 1230, Patient 26’s medical record was reviewed and reflected: * Patient 26 was assigned to a 9K alcove inpatient bed on 10/21/2025 at 1433 after a MVA. * On 10/21/2025 at 2138, an ED physician noted “... patient required admission for further care ... Multiple rib fractures involving four or more ribs ... Closed fracture of multiple ribs of left side ...” * On 10/22/2025 at 0950, an Occupational Therapist (OT) noted: “Pt presents with occupational performance deficits secondary to pain and decreased activity tolerance. Able to progress to ambulating from hallway bed to bathroom using FWW to perform toileting and hand washing. No physical assist needed but experiencing increased pain when rising from low toilet and when bending/reaching for faucet and soap. Also became nauseous and dizzy afterwards. Able to make it back to bed without any adverse events ... Anticipate with improved pain management, pt will functionally progress ... Will benefit from trial of bed mobility towards right side of bed to see if helpful for pain control (not currently possible d/t alcove/hallway bed).” * On 10/23/2025 at 1958, Patient 26, signed a “Discharge of Patient From Hospital Against Medical Advice.” Refer to Tag A-0118, Finding 4.a., Patient 26’s grievance for further details. The hospital failed to assess whether a patient with left-sided injuries could safely access patient care items located on the left side of the bed, (the only place a side table could be placed), prior to placement in the alternative care space. The hospital failed to assess whether Patient 26 could safely egress from the left side of the bed prior to placement in the alternative care space. Refer to Tag A-0022, Finding 2, a description of the 9K alcove gurney and space which did not allow for a patient to egress from both sides of the gurney. The alcove space was not wide enough for the gurney to be centered and therefore it was placed with the right side butted up against the right wall of the alcove. 6. Refer to Tag A-118, Findings 3.b., 3.c., 3.d., and 5.a., patient grievances and incidents involving the patient alcoves on 9K and 11K which detail the hospital’s failure to provide privacy, patient safety, accessible bathrooms, and adequate visitor accomodations; and failure to follow hospital policy for negative Covid-19 tests prior to alcove placements. Regarding Patient Rights, right to safe care and medication administration: 7. Refer to Tag A-1081, which reflected two separate, vaccine administration errors involving pediatric patients, with one incident affecting more than 100 patients. In October of 2023, 177 pediatric patients under the age of 12 years received up to twice the ordered dose of the Covid-19 vaccine which had been administered by Medical Assistant(s). In December of 2025, 19 pediatric patients under the age of 12 years were administered a Covid-19 vaccine that was Beyond the Use Date, contrary to hospital policy. These vaccines were also administered by Medical Assistant(s).”

“PATIENT VISITATION RIGHTS CFR(s): 482.13(h)(3), (h)(4) [A hospital must have written policies and procedures regarding the visitation rights of patients, including those setting forth any clinically necessary or reasonable restriction or limitation that the hospital may need to place on such rights and the reasons for the clinical restriction or limitation. A hospital must meet the following requirements]: (3) Not restrict, limit, or otherwise deny visitation privileges on the basis of race, color, national origin, religion, sex, gender identity, sexual orientation, or disability. (4) Ensure that all visitors enjoy full and equal visitation privileges consistent with patient preferences. This Standard is not met as evidenced by: 44104 Based on observations, interviews, grievance and incident documentation reviewed for 2 of 13 patients (Patients 16 and 27), 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 visitation privileges for patients placed in alternative care spaces were recognized, protected and promoted. Findings include: 1. Refer to Tag A-0118, Findings 3.b. and 5.c., grievances detailing patient concerns with a lack of adequate space in the alternative care spaces and/or lack of chairs for visitor comfort. 2. Refer to Tag A-0022, Finding 2.a., the surveyor’s observation of two alternative care spaces that could not accommodate a visitor comfortably. 2. Refer to Tag A-0144, Patient Rights, Finding 1, the patient handout for shared spaces, and Finding 3, the hospital’s alternative care policy which restricted overnight visitors.”

“FORM AND RETENTION OF RECORDS CFR(s): 482.24(b) The hospital must maintain a medical record for each inpatient and outpatient. Medical records must be accurately written, promptly completed, properly filed and retained, and accessible. The hospital must use a system of author identification and record maintenance that ensures the integrity of the authentication and protects the security of all record entries. This Standard is not met as evidenced by: 44104 Based on review of policies and procedures, incident reports and grievances, medical record review of 5 of 10 patients (Patients 1, 2, 3, 4, and 5), and review of other documentation, it was determined that the hospital failed to develop, and implement policies and procedures for safe vaccine administration and accurate documentation. The hospital failed to accurately document in the patients’ medical records the dosages of injectable medication administered to patients because the actual amount administered to patients was unknown. Findings include: 1. Refer to Tag A-1081, Outpatient Services: * Findings 6.a. through 6.f., vaccine administration records of patients who may have received up to double the ordered dose of the Covid-19 vaccine, however, all doses were documented as the ordered dose of 0.25mL. * Finding 7, a list of 177 pediatric patients who may have received up to double the ordered dose of the Covid-19 vaccine, however, all doses were documented as the ordered dose of 0.25mL. * Finding 9, the ACOM interview and description of MA practices when drawing up injectable medications (vaccines).”

“STANDARD TAG FOR OUTPATIENT SERVICES CFR(s): 482.54 Standard-level Tag for §482.54 Condition of Participation: Outpatient Services If the hospital provides outpatient services, the services must meet the needs of the patients in accordance with acceptable standards of practice. This Standard is not met as evidenced by: 44104 Based on review of policies and procedures, incident reports and grievances, medical record review of 5 of 10 patients (Patients 1, 2, 3, 4, and 5), review of 3 of 4 MA training records (MA20, MA22 and MA23), and review of other documentation, it was determined that the hospital failed to develop, and implement policies and procedures for safe vaccine administration. The hospital failed to document adequate training that ensured competency for medical personnel who administered vaccines to patients. The hospital failed to correctly document in the patients’ records the amount of medication administered to patients. Findings include: 1.a. The policy in effect at the time of the complaint was titled, “Medication Administration Policy” and dated “09/22/2023.” It was reviewed and reflected: * “Purpose ... To describe the OHSU Healthcare patient medication administration and documentation process.” * “Persons Affected ... Any qualified OHSU Healthcare workforce members who prepare, distribute, administer, waste or document patient medications.” * “OHSU patient medication will be administered and documented according to the safe medication administration described in this policy.” * “Definitions ... Seven rights ... Right patient ... Right medication ... Right dose ... Right route ... Right time ... Right documentation ... Right indication.” * “Responsibilities ... It is the responsibility of all OHSU Healthcare workforce members involved in the administration of patient medications to comply with this policy.” * “Medication administration responsibilities ... Conduct all processes for safe medication administration, including medication and patient barcode scanning, the seven medication administration rights, two patient identifiers and allergy review ... Review references or contact Pharmacy if unfamiliar with the medication or administration requirements ... Refer to Authorization to Handle, transport, and Administer policy outlines who may administer medications.” * “Summary of Documentation, Administration, Returns & Waste ... MAR Documentation ... Occurs at the time of administration ... For MAR chart corrections greater than 14 days, refer to hospital procedure.” * “At time of medication administration ... Check dose label against IHR order for congruence of medication name, dose or strength and form appropriate for route. If the manufacturer’s label is present, check it against Pharmacy’s label ... Verify that the medication has not expired ... Visually inspect the medication for particulates, discoloration or other loss of integrity ... Contact Pharmacy for discrepancies if necessary ... Conduct the seven rights ... Scan each individual medication prior to administration. Note: scanning the patient armband and medication provides a double check of the 7 rights, it is not a substitute for them.” 1.b. The current, updated policy titled, “Medication Management: Procurement, Distribution, Preparation, Labeling, Beyond Use Dating, Security, Storage, Disposal and Expired Medication Policy” and dated “05/29/2024” was reviewed and reflected: * “Purpose ... This policy provides OHSU Healthcare workforce members guidelines for procurement, distribution, preparation, dispensing ... to ensure security and safety of patient medications.” * “Persons Affected ... This policy applies to OHSU Healthcare workforce members involved in patient medication management.” * “OHSU Healthcare workforce members will safely procure, distribute, prepare, dispense ... patient medications.” * “Definitions ... Beyond-Use Date (BUD): A use-by date assigned by pharmacy based on guidelines adopted from standard sources to assure potency. A beyond-use-date is the date that identifies when the medication is at risk for chemical degradation or contamination and signifies the date and time (if applicable) beyond which the medication may not be used.” * “Medications: Includes prescription medications ... vaccines ... administered to persons to diagnose, treat, or prevent disease or other abnormal conditions ... and any product designated by the Food and Drug Administration (FDA) [http://www.fda.gov/] as a drug.” * “National Drug Code (NDC) Directory: The Food and Drug Administration (FDA) searchable website.[http://www.fda.gov/cder/ndc/] for medications used to determine if a product is a drug.” * “ OHSU authorized workforce members: Persons who are authorized to dispense, prepare, store, administer (if applicable) or otherwise access patient medications include nurses and nursing students ... medical assistants ... “ * “SDV: Single dose vial.” * “Responsibilities ... All OHSU Healthcare workforce members are required to understand and comply with this policy as it related to their job responsibilities.” * “Beyond Use Dating (single dose and multidose) ... In the event of a shortage or event where a manufacturer may allow for a medication to be used beyond its expiration date, it must be approved by pharmacy and documented in our drug information database.” * “Expired/Outdated Medications ... All expired/outdated medications will be removed from patient care areas ... Medications will be visually examined for expiration date, mislabeling, and particulate matter and damaged packaging.” * “Pharmacy Medication Management Rounds ... Pharmacy will inspect patient care health-system medication storage areas every two months for proper storage conditions, integrity of medication, labeling, randomly spot check for expired/outdates ... “ * “External Links/Relevant References ... Food and Drug Administration (FDA).” The policy failed to address the documentation of medication in the patient’s medical record after administration, such as date/time administered, dose, route, location (if applicable), etc. The policy failed to address the “Seven Rights” or whether it was required that the correct dosage be verified prior to administration. 2. A policy titled “Healthcare Delegation Protocol Administration of Immunizations- Adult/Pediatric” dated “05/31/2023” was reviewed and reflected: * “Purpose ... This Delegation Protocol provides direction for ... authorized non-providers for administration of immunizations to patients using the standard ACIP immunization schedule ... This protocol is intended to: improve efficiency, quality, and safety, and is based on best available evidence.” * “Authorized staff are Registered Nurses ... and/or Medical Assistants with the competencies required to administer vaccines.” * “Protocol Requirements ... Review medication and food allergies, along with immunization history, and any history of reactions to vaccines ... Provide the patient or their parent or legal representative a copy of the most current federal Vaccine Information Statement (VIS).” The policy failed to address the documentation of medication in the patient’s medical record after administration, such as date/time administered, dose, route, location (if applicable), etc. The policy failed to address the “Seven Rights” or whether it was required that the correct dosage be verified prior to administration. 3. A policy titled “Healthcare Delegation Protocol Covid-19 Vaccine for Ambulatory - Adult /Pediatric” dated “05/03/2021” was reviewed and reflected: * “This Delegation Protocol provides direction for initiation of care by authorized non-providers for patients who request vaccination against the SARS-CoV-2 virus based on specific criteria outlined below. This protocol is intended to improve safety and efficiency and to reduce morbidity and mortality from Covid-19 by vaccinating all patients who meet eligibility criteria.” * “Authorized staff are RNs, LPNs, and MAs with the competencies required to perform this protocol and trained in the use of the protocol. Additionally, non-clinical staff members who have received the COVID-19 vaccine administration training are also authorized.” * “Protocol Requirements ... Review screening tool ... If no exclusions, proceed with COVID-19 vaccination for appropriate age ... Patients 6 months or older can have Pfizer or Moderna only ... Children 6 months to 4 years must be given a vaccine by the same manufacturer (i.e. Pfizer or Moderna) for all doses ... Vaccinate using the appropriate table (general population or immunocompromised) and intervals.” * “Table 1: OHSU Vaccination Schedule in the General Population ... Ages 6 months to 4 years ... Moderna ... Dosage (mL/ug) ... 025mL/ug [sic] ... Document if vaccine given or refused in the IHR.” Dosages for patients ages 5 years to 11 years were not included in this table. * A vaccination schedule titled, “Table 2: OHSU Vaccination Schedule for For People with Moderate or Severe Immunocompromise,” listed six rows of Covid-19 vaccine preparations with instructions for different patient ages/scenarios. Of the six scenarios, only one noted that for “6 years and older, a single additional age-appropriate dose of Moderna COVID-19 Vaccine, bivalent may be administered.” Dosages for patients ages 5 years to 11 years were not noted in this table, or anywhere else in this policy. The policy failed to address the “Seven Rights” or whether it was required that the correct dosage be verified prior to administration. 4. A vaccine package insert obtained from the manufacturer on 03/16/2026 at 1314 titled, “Moderna Covid-19 Vaccine (2023-2024 Formula), for Individuals 6 Months Through 11 Years of Age” and dated “09/2023” was reviewed and reflected: * “Moderna COVID-19 Vaccine (2023-2024 Formula) Dosing Regimen, Dose and Schedule ... Single dose, 0.25 mL.” * “Dosage Forms and Strengths ... Moderna COVID-19 Vaccine is a suspension for injection. A single dose is 0.25 mL.” * “Dosage and Administration ... Each single dose vial contains one dose of 0.25 mL for ages 6 months through 11 years. Discard vial after single use.” * “Dose and Schedule ... Individuals 6 Months Through 4 Years of Age by Moderna COVID-19 Vaccination Status ... 2 doses, 0.25 mL each ... Dose 1: month 0 ... Dose 2: month 1 ... Individuals 5 Years Through 11 Years of Age Irrespective of COVID-19 Vaccination Status ... Single dose, 0.25 mL.” * “Dosage Forms and Strengths ... Moderna COVID-19 Vaccine is a suspension for injection. A single dose is 0.25 mL.” The package insert for the 2023-2024 Moderna COVID-19 pediatric vaccine reflected several times throughout the provided information that the pediatric dosage was 0.25 mLs. Although the insert reflected that a vial contained a single dose, at no time did the manufacturer recommend or note that the full contents of the vial should be administered to the patient as a single dose. The package insert clearly reflected that a single dose was 0.25 mLs. 5. An excel spreadsheet titled, “ITSUP-1600523_DNV_PedsCovidVaccine (1)” provided by the hospital on 01/30/2026 was reviewed and reflected: * Between 10/09/2023 and 10/16/2023, the excel documentation reflected that 177 patients between the ages of 6 months and 11 years of age had received a Moderna Covid-19 vaccine in the following satellite clinics: “Campus Peds DCH ... FM Faculty Bvtn ... FM Faculty CHH1 ... Ped Westside.” * Two additional clinics and patients were listed but were not satellites of the hospital, an FQHC and an RHC. These two clinics and patients were referred to the regulatory department with oversight for these clinics. * All 177 pediatric patients had the following documented dosage, “0.25 ML DOSE” of the Moderna Covid-19 vaccine. * There were no pediatric patients under the age of 12 years-old listed between 10/04/2023 and 10/08/2023, although the hospital noted in Finding 9 that the incident occurred between 10/04/2024 and 10/16/2023. 6.a. A review of 5 of 5 patient medical records who received a Moderna Covid-19 vaccine was conducted on 01/28/2026 with the VPCNO, the DPA, the NM, and other hospital staff beginning at 1345. The following information was revealed: 6.b. Patient 1, a 10 month-old with special needs, received a “SARS-COV-2 (COVID) 2023-24 (6MO-11YR)(MODERNA), MRNA, 0.25 ML DOSE” on 10/10/2023. * The vaccine was administered by MA20. MA 21 “Verified orders, lot number, expiration date, route ...” * A communication note on 10/21/2023 at 0844 reflected, “Left message to call back and discuss recent COVID-19 vaccination visit with DCH General Pediatrics when able.” * A second communication note on 10/21/2023 at 1455 reflected, “Left message for ... family to discuss ... recent COVID 19 vaccination, asked for return call ...” 6.c. Patient 2, a two year-old, received a “SARS-COV-2 (COVID) 2023-24 (6MO-11YR)(MODERNA), MRNA, 0.25 ML DOSE” on 10/14/2023. * The vaccine was administered by MA20. * There was no documented verification of orders, lot number, expiration date or route by a second MA. * A communication note on 10/21/2023 at 1208 reflected, “Information Given: Shared with family that during recent vaccine administration visit, a larger dose than expected had been given of the Moderna COVID-19 vaccine to their child. This could have been up to twice the recommended dose, which is equivalent to an adult dose.” 6.d. Patient 3, a four year-old, received a “SARS-COV-2 (COVID) 2023-24 (6MO-11YR)(MODERNA), MRNA, 0.25 ML DOSE” on 10/14/2023. * The vaccine was administered by MA20. * There was no documented verification of orders, lot number, expiration date or route by a second MA. * A communication note on 10/21/2023 at 1250 reflected, “Information Given: Shared with family that during recent vaccine administration visit, a larger dose than expected had been given of the Moderna COVID-19 vaccine to their child. This could have been up to twice the recommended dose, which is equivalent to an adult dose.” 6.e. Patient 4, a five year-old, received a “SARS-COV-2 (COVID) 2023-24 (6MO-11YR)(MODERNA), MRNA, 0.25 ML DOSE” on 10/16/2023. * The vaccine was administered by MA22. * There was no documented verification of orders, lot number, expiration date or route by a second MA. * A VIS was not provided to the patient/patient guardian in accordance with hospital policy. * A note dated 10/17/2023 at 1719 reflected, “Pt received COVID vaccine yesterday and today developed low-grade temporal fever of 100 and pain at the injection site. Mom tx pain with Tylenol. Pt is staying hydrated and not feeling ill otherwise. No rash or other concern for allergic reaction.” * A communication note on 10/21/2023 at 1254 reflected, “Information Given: Shared with family that during recent vaccine administration visit, a larger dose than expected had been given of the Moderna COVID-19 vaccine to their child. This could have been up to twice the recommended dose, which is equivalent to an adult dose.” 6.f. Patient 5, a 10 year-old, received a “SARS-COV-2 (COVID) 2023-24 (6MO-11YR)(MODERNA), MRNA, 0.25 ML DOSE” on 10/10/2023. * The vaccine was administered by MA23. MA20 “Verified orders, lot number, expiration date, route ... “ * A communication note on 10/21/2023 at 1336 reflected, “Information Given: Shared with family that during recent vaccine administration visit, a larger dose than expected had been given of the Moderna COVID-19 vaccine to their child. This could have been up to twice the recommended dose, which is equivalent to an adult dose.” The hospital failed to fully implement its medication administration P&Ps. The hospital failed to accurately document each patient’s vaccine administration. MAs did not verify the correct vaccine dose prior to administration and then documented the dose as a single dose of “0.25 mL,” refer to Finding 1, the hospital’s policy to verify “Right Dose ... Right Documentation.” Refer also to Findings 3 and 4, the amount of a single dose per hospital P&P and the manufacturer’s IFU, which noted a “single dose” as 0.25 mL, contrary to the medical record notes which reflected, “a larger dose than expected had been given of the Moderna COVID-19 vaccine.” The patient medical records failed to reflect a correction of the 0.25 mL dose of the Moderna Covid-19 vaccine that had been administered. In fact, due to the MAs’ practice of drawing up an entire vial’s contents prior to administration without verifying the amount of solution in the vial, it would be more than likely that all vaccines given prior to this incident had unknown doses administered to patients, and as a result, incorrect documentation of dosages recorded in patients’ EHRs. This practice finding was confirmed at the time of the vaccine incident review by the ACMO and other hospital staff in attendance, refer to Fining 9, the ACMO description of MA vaccine administration practices. Processes and protocols for vaccine administration procedures were not clearly defined or implemented consistently. For example, Patient 1’s and Patient 5’s medical record noted that a second MA verified the “orders, lot number, expiration date [and] route.” In contrast, Patient 2, Patient 3, and Patient 4 did not have a second MA verification noted, and Patient 4 did not receive the required VIS form in accordance with hospital P&Ps, refer to Finding 2, “Administration of Immunizations” protocol. During the medical record review on 01/28/2026, both the NM and the DPA stated that a second MA verification was required. However, on 01/29/2026 at 0949, the DPA stated “just some clinical areas use that standard work practice” and that it was “not required per policy.” Refer also to Finding 13, MA interviews. 7. On 01/28/2026, the hospital provided a list of patients who were sent the letter notifying them that they may have received up to 0.5 mL of the Moderna Covid-19 vaccine. It was reviewed and reflected: * There were 161 patients listed. These patients were also listed in the excel spreadsheet noted in Finding 4 as having received a 0.25 mL dose of the Moderna Covid-19 vaccination between 10/09/2023 and 10/16/2023. * Patient 1, Patient 2, Patient 3, Patient 4, and Patient 5 were included on the list of affected patients who received the letter. 8. An undated template of the letter sent to the guardians of the affected patients was reviewed and reflected: * “We are reaching out by phone and letter about your child’s recent COVID vaccine ... Earlier this month, [Patient name] may have received up to twice the recommended dose of the Moderna COVID-19 vaccine. The standard single dose for kids 6 months to 11 years old is 0.25mL. Your child may have received up to 0.5mL. This is the same as an adult dose.” * “We believe the risk is low of any serious harm. There have been dozens (possibly hundreds) of reports of children across the country getting an adult dose of the COVID-19 vaccine with no serious harm. This 2023-2024 Moderna COVID-19 vaccine is new, but it is very similar to the other COVID-19 vaccines that millions of people safely received.” * “We believe this happened because of the way the vaccine vials were labeled. The 2023-2024 Moderna vaccine is new and so is the packaging. Each vial is labeled as a single dose of 0.25mL, but there is actually up to 0.5mL in each vial. We let Moderna know that the label is confusing and could lead to people getting the wrong dose.” * “We are retraining our clinic staff on how to safely give this vaccine, and we have notified Moderna that their packaging is not clear.” 9. During a review of the vaccine/medication error incident on 01/28/2026 beginning at 1150 with the DPA, the NM, the ACMO, and other hospital staff, the hospital provided a verbal and written summary that reflected: * The hospital discovered “across six clinics and three departments” more than 174 pediatric patients may have received “up to double the amount of the intended dose” of the Moderna Covid-19 vaccine from single dose vials between October 4, 2023 and October 16, 2023. The hospital noted they “were alerted of the Moderna COVID-19 vaccine containing larger than normal amounts of overfill, [of] which more than the intended amount of the vaccine was drawn into a syringe, potentially resulting in extra doses being administered.” * The root cause identified several areas, and included “Labeling errors and confusing instructions on vaccine vials” as well as “Lack of investment in skill building and continued education of MAs.” * The ACMO explained that MAs responsible for drawing up and administering the Covid-19 vaccine were drawing up the entire contents of a single dose vial as a “single dose” and “not visualizing 0.25 mLs in the syringe.” * The hospital also stated that the “overfill” in the vial was “approximately” double the pediatric dose and that they notified the manufacturer of the “labeling error” on the single dose vials. * The surveyor asked whether it was standard practice for nursing personnel to draw up injectable medication from vials without verifying the amount being drawn up into the syringe. The DPA responded, “No.” The findings were confirmed at the time of the review by the ACMO and other hospital staff. The hospital failed to implement and follow it’s procedures for safe medication administration. The amount of medication withdrawn from the “Single dose” vial was not verified: - With the pediatric vaccine vial labeled “Single dose 0.25 mL.” - With what was printed and reiterated several times in the vaccine package insert, “A single dose is 0.25 mL.” - Per the hospital’s P&P; the “Seven Rights”, i.e., “Right Dose.” - In accordance with nationally recognized standards of practice for injectable medication administration. The MAs’ practice was to withdraw the entire contents of the vial and to administer the entire contents of the vial to patients. This practice did not follow the manufacturer’s instructions for use prior to administration, refer to Finding 4, the package insert. The hospital stated that the error occurred due to mislabeling and excessive overfill, however, overfill of injectable medication vials is a standard practice in the production of injectable medications and vaccines, and is an expected occurrence when accessing both single-dose and multi-dose vials for medication administration. According to an FDA manual of policies and procedures titled, “Allowable Excess Volume/Content in Injectable Drug and Biological Products” dated “01/28/2022” (published prior to the 2023 incident), downloaded on 03/13/2026 at 0841 from “https://www.fda.gov/media/155066/download,” it reflected, “A factor that contributes to unsafe handling and injection techniques by ... healthcare providers is an allowance for an excess volume in vials that results in leftover drug product that can be used as a partial or second dose. If the contents of the vial do not allow delivery of the labeled dose, the healthcare provider ... would have to underdose or use additional vials to administer the labeled dose. Vials containing insufficient volumes can also cause problems during patient administration.” Also, a WHO document titled, “Covid-19 Vaccine Job Aide” dated “15 April 2021” and downloaded 03/15/2026 at 1846 reflected that manufacturer overfill of vaccine vials is a standard practice. The guidance reflected, “What is volume overfill? Filling extra vaccine in a vial is a common practice in vaccine production and is called ‘overfill.’ Manufacturers include extra vaccine to aid health workers in delivering the intended number of accurate doses.” The hospital failed to clearly document the amount of vaccine administered to patients. The hospital acknowledged that several hundred pediatric patients may have received an excess of the ordered Covid-19 vaccine dose. However, the documentation in the patients’ medical records did not accurately reflect the amount of vaccine that was drawn up and administered to each patient. Additionally, it was unclear whether patients were overdosed or underdosed during similar vaccination visits as the MAs were not verifying the contents of syringes when drawing up the Covid-19 from a single dose vial and were administering the full contents of each vial. Refer to Finding 9, the ACMO description of MA vaccination practices. It was unclear how the labeled “Single dose” vial contributed to the medication error when MA medication practices were not standardized and did not follow nationally recognized standards for injectable medications or vaccines. Regarding MA Training 10.a. A review of the MA training for injectable medication administration reflected: 10.b. MA20’s training records reflected: * An observation checklist of skills titled, “Injection Checklist” listed clinical tasks and techniques related to administration of intradermal, intramuscular, and subcutaneous injections. * MA20’s first name was misspelled (this was confirmed during the medical record review) and MA20’s last name was not written anywhere on the document; therefore it was unclear whether this checklist belonged to MA20. * The checklist encompassed 5 observations beginning 09/30/2021 and ending 09/30/2021. * The checklist listed 27 tasks. Two of the 27 tasks referenced verifying orders. One of 27 tasks referenced checking the expiration date. One of 27 tasks discussed documenting in the EHR per protocol. * Of the 27 tasks, four of 10 columns had check marks indicating the task was complete, five of 10 columns had a line drawn from the top of the column to the end of the column, and one of 10 columns was blank. * There was no signature, title or credentials for the trainer, and it was not clear what training, competencies or qualifications were held by the trainer. * No other documentation of injectable medication training for MA20 was provided. 10.c. MA22’s training records reflected: * A training document titled, “MA Hands-On Clinical Competencies” contained 11 tasks observed between 05/24/2023 and 05/26/2023 and noted MA22’s full name. * The checklist contained no information on verification of orders or expiration dates. * A column titled, “Method” [of verification of competency] was blank for all 11 tasks listed. * Two columns titled, “Rating” and “Validated By” contained “Pass” and the trainers’ full names listed next to each task, respectively. However, no titles or credentials were noted next to the trainers’ names. 10.d. Another training document for MA 22 with a version date of “06112024” titled, “Medication Administration MA Competency Confirmation” was provided and noted MA22’s full name and a date of “6/28/.” The year was illegible. * The document included five goal areas. These were: “Discussion Elements ... Policies ... Medication Math ... Observation Medication Administration [and] ... Evidence Base [sic] Resources.” * Listed under “Discussion Elements” were “the 7 rights of medication administration” and “differences between single dose and multidose vial.” * Listed under “Policies” were three policies, “Medication Administration ... Medication Management [and] ... Verbal Orders & Telephone Orders.” * Under “Medication Math” was a scenario about reconstituting medication and calculating the correct concentration of medication after reconstitution. * Listed under “Observation Medication Administration” were 10 tasks, including but not limited to: “Observe 7 Rights ... reviews medication order ... prepares medication [and] ... scan medications.” * Under “Evidence Base [sic] Resources” was “Staff to provide two examples of evidence base [sic] resources they can use.” * The second page of the training document included the following definitions: - “What are the 7 rights ... Right dose ... Right documentation ...” - “A single dose vial ... Sometimes only contains 1 dose but can be overfilled to be more than 1 dose.” 10.e. MA23’s training records reflected: * An observation checklist of skills titled, “Injection Checklist” listed clinical tasks and techniques related to administration of intradermal, intramuscular, and subcutaneous injections. * MA23’s full name was noted. * The checklist encompassed 5 observations beginning “2/7” or “8/7” and ending “2/7” or “8/7”; the date was illegible in two columns and there were no years noted. * The checklist listed 27 tasks. Two of the 27 tasks referenced verifying orders. One of 27 tasks referenced checking the expiration date. One of 27 tasks discussed documenting in the EHR per protocol. * Of the 27 tasks, 10 of 10 columns had all but four checked marked indicating the task was complete. The other four boxes had “N/A” noted for those tasks. * The trainer’s name was noted at the top of the form, however, there was no signature, title or credentials for the trainer, and it was not clear what training, competencies or qualifications were held by the trainer. 10.f. Another training document for MA 23 titled, “MA Hands-On Clinical Competencies” contained 11 tasks observed on 07/19/2023 and noted MA23’s full name. * The checklist contained no information on verification of orders or expiration dates. * A column titled, “Method” [of verification of competency] was blank for all 11 tasks listed. * Two columns titled, “Rating” and “Validated By” contained “Pass” and the trainer’s full name listed next to each task, respectively. However, no title or credentials were noted next to the trainer’s name. 11. A PowerPoint presentation with 17 slides titled, “Injections” dated “January 2025” was reviewed and reflected: * A slide titled, “7 Rights of Medication Administration” contained no information about vial overfill or verification the dosage amount drawn up in a syringe. The training notes reflected the following about expiration dates: “Be sure you have the correct medication and it is not expired.” There were no notes in this slide about Beyond Use Date (BUD). * A slide titled, “Case Study” with four embedded pictures: - Picture 1: A single dose vial of “Covid-19 Vaccine ... 2023-2024 Formula ... For 6m through 11y ... 0.25mL Single Dose Vial.” - Picture 2: A syringe with 0.5mLs of fluid drawn up. - Picture 3: A vial of “Covid-19 Vaccine ... 2023-2024 Formula ... For 12y and older ... 0.5mL Single Dose Vial.” - Picture 4: A vial of “Covid-19 Vaccine ... Multi-dose vial 10 doses of 0.5mL.” The slide notes reflected the following information: “An event was discovered to be happening at OHSU that resulted in hundreds of incident reports due to misleading labels. The first vial shown is a ‘single dose’ vial, and as you can see, the labeling states 0.25mL. However, when the full volume of liquid in the vial is drawn up, it is 0.5 mL. Always double check the orders for the intended amount and the amount of liquid that is being drawn up! Sometimes, even single dose vials that are intended to contain the amount that should be administered can be overfilled. ALWAYS triple-check the volume you have drawn up matches the volume indicated in the order.” * No other slides addressed visual verification of dosage amounts in syringes, expiration dates or BUDs. It was unclear whether a single slide, coupled with the provided MA checklists, constituted adequate education for medical personnel who admnistered injectable medications to patients. The hospital was unable to provide documentation of inservices that were provided to medical personnel after the October 2024 vaccination administration errors that affected approximately 177 pediatric patients. Considering the scope and type of medication administration errors that occurred, the checklists and PowerPoint presentation lacked consistent messaging and content related to reading and understanding labels, verifying dosages and orders, and documentation of hands on clinical practice in drawing up injectable medications correctly and consistently. The training lacked emphasis on correcting medication administration documentation. 12. During an interview with the DPA, the NM, the CMO and others on 01/28/2026 beginning at 1150, they acknowledged the vaccine errors and reiterated that it was due to vial mislabeling, overfill and lack of investment in MA education, refer to Finding 9, the facility’s summary of the incident. The DPA was asked whether the Medication Administration policy applied to the clinics. The DPA responded, “Yes.” However, the DPA added that not all safety protocols were the same. For example, the DPA was asked whether patients were scanned in the clinic prior to receiving vaccines and the DPA responded, “No.” Additionally, the ACMO stated that in response to the vaccine administration errors, the hospital led a “robust education” regarding single dose vials and overfill. 13. During an interview with two clinic MAs, MA20 and MA24 on 01/28/2026 beginning at 1547, MA 20 was asked about additional training received after the vaccine incident. MA20 stated an inservice occurred with an RN and they explained that there was a “double dose” in the vials. MA20 also stated that additional online training had been completed. When asked when that inservice occurred, MA20 could not recall a date and the hospital did not provide dates and times when the inservices occurred, although that information had been requested. A second MA, MA24 was asked to walk through the steps performed for vaccine administration. During the verbal description, the MA stated that it was required to have another MA verify the medication being administered. The hospital failed to provide and document consistent training for MAs in injectable medication and vaccine administration that was standardized across the system. For example, although the policy, “Medication Administration” applied to the clinics, the DPA stated that not all safety protocols were utilized as described in policy, refer to Finding 12, clinic patients were not scanned in accordance with hospital policy. Additionally, the ACMO stated that education was provided to MAs, however, MA24 still responded that a second MA verification of medication was expected although this practice was not in policy. The DPA had also stated that some clinical areas used that practice and confirmed that it was not in policy, refer to Finding 6.f. MA20 stated that the vaccine errors which occurred across several clinics was due to overfill and did not reference MA practices for drawing up injectable medications which were not in accordance with nationally recognized standards of practice. Refer to Finding 9, the ACMO’s statement that MAs were drawing up the entire contents of a vial. The lack of consistent education documentation for MAs, coupled with MA statements reflected a lack of sufficient retraining and education to prevent a similar event from recurrence, see also Finding 14., ongoing lapses in the administration of the Covid-19 vaccine. 14. An excel spreadsheet titled, “PSIs 11012025-01282026” provided by the hospital listing Patient Safety Incidents was reviewed and reflected: * On 12/11/2025, after updated MA education on injectable medication and vaccine administration had been provided, 19 medication errors occurred involving Covid-19 vaccine administrations. The 19 patients, all seen in the same pediatric clinic, received an “Expired or Deteriorated Drug.” For all 19 patients it was noted, “These patients received a covid vaccine that was used beyond the BUD.” * On 01/13/2026, after updated MA education on injectable medication and vaccine administration, a patient in a pediatric clinic received the “Wrong Drug or Substance.” A note on this patient reflected, “After giving a vaccine to this patient, I scanned in the covid vaccine and saw that it was 12+ Covid Pizer [sic] instead of Moderna that I administered. I did tell an attending and resident right away that the wrong dose was given. Prior [to] giving [the] vaccinee [sic], I did have a co-worker double check the vaccine vile [sic].””