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10300 NE HANCOCK STREET

PORTLAND, OR null

GOVERNING BODY

Tag No.: A0043

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Based on observations of 10 of 14 patients (Patients 15, 16, 17, 18, 19, 21, 22, 23, 28, and 31), interviews, review of medical record documentation for 16 of 23 patients whose records were reviewed for aspects of care and services (Patients 1, 2, 3, 4, 5, 6, 8, 9, 13, 15, 16, 17, 18, 21, 22, and 23), review of incident documentation for 14 of 16 patients reviewed for investigation of incidents (Patients 1, 2, 3, 5, 6, 7, 8, 13, 16, 18, 19, 20, 22, and 23), review of grievance documentation for 10 of 10 patients reviewed for identification and response to grievances (Patients 1, 3, 6, 7, 13, 18, 24, 25, 26, and 27), review of employee competency documentation for 2 of 2 employees (Former Employee 1 and Employee 2), and review of hospital P&Ps and other documentation it was determined that the governing body failed to ensure the provision of safe and appropriate care to its medically complex and vulnerable patients in a manner that complied with all Conditions of Participation.

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

Findings include:

1. Refer to the findings cited at Condition Tag A-115 under CFR 482.13 - CoP: Patient's Rights. Those findings reflected the hospital's failure to ensure each patient's rights were protected and promoted. The hospital failed to promptly identify, fully investigate, resolve, and provide clear and complete responses to patients' grievances, including allegations of abuse and neglect (Tag A-118); failed to develop and implement clear timeframes for the provision of written responses to grievances (Tag A-122); failed to ensure that patients were afforded personal privacy during the provision of care (Tag A-143); failed to ensure the provision of care and services in a safe manner and in a safe environment (Tag A-144); failed to promptly and appropriately identify, investigate, and respond to allegations of abuse, and incidents that reflected potential neglect, and to develop and implement corrective action plans to prevent recurrence (Tag A-145); failed to, prior to application of restraints, conduct comprehensive assessments of patients' needs for physical or chemical restraints, that included differentiation between those needed for non-violent, non-self destructive behavior and those needed for violent or self-destructive behavior, and that evaluated whether less restrictive or alternative interventions were effective (Tag A-164); failed to ensure that restraint use and management were in accordance with clear and complete plans of care that were based on a comprehensive assessment (Tag A-166); failed to ensure restraints were only applied under physicians' orders that were clear, complete, and patient-specific (Tag A-168); failed to ensure that restraints used to manage violent or self-destructive behaviors were renewed at a maximum of every four hours for up to a total of 24 hours (Tag A-171); and failed to appropriately observe and monitor the condition of patients in restraints, and provide necessary care and services to ensure the safety and well-being of the patients (A-175).

2. Refer to the findings cited at Condition Tag A-263 under CFR 482.21 - CoP: QAPI. Those findings reflect the hospital's failure to develop and implement an effective, ongoing, hospital-wide QAPI Program based on the findings cited in this CMS 2567 report.

3. Refer to the findings cited at Condition Tag A-385 under CFR 482.23 - CoP: Nursing Services. Those findings reflected the hospital's failure to ensure an organized and effective nursing services. The hospital failed to ensure the RN conducted clear and complete nursing assessment of patients' individual physical and psychosocial problems and needs, that services were provided in accordance with clear and complete physician's orders, and that nursing services were coordinated with the other disciplines involved (Tag A-395); failed to ensure that the RN developed and implemented patients' plans of care that were clear, complete, individualized and coordinated with the other disciplines involved for the provision of safe and appropriate care and services (Tag A-396); and failed to ensure that RNs and LPNs administered and documented routine and PRN medications in accordance with clear and complete physician's orders, patient-specific PRN indications, and P&Ps, evaluated and documented patients' responses to routine and PRN medications given, and reported to the physician and pharmacist concerns about orders, medication regimens, and patients' responses to medications (Tag A-405).

4. Refer to the findings cited at Condition Tag A-700 under CFR 482.41 - CoP: Physical Environment. Those findings reflect the hospital failed to maintain an environment that was clean and in good repair (A-701); failed to comply with the Life Safety From Fire requirements (A-709); and failed to develop and implement a preventive maintenance program that ensured biomedical and other equipment were maintained in accurate and safe working order (A-724)

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5. Refer to the findings cited at Condition Tag A-747 under CFR 482.42 - CoP: IPC and Antibiotic Stewardship Programs. Those findings reflect the hospital's failure to fully develop and implement an effective hospital-wide IPC Program and systems for surveillance, prevention, and control of HAIs and other infectious diseases including failure to identify an infection preventionist/infection control professional with specialized training in infection prevention, i.e., HAI surveillance, and who was responsible for the IPC Program; and failure to ensure the governing body appointed an infection preventionist/infection control professional based on medical and nursing leadership recommendations (Tag A-748); failure to conduct adequate and ongoing Risk Assessments in the areas of Infection Prevention, TB Infection Control, and healthcare Water Management; failure to ensure a clean and sanitary environment; to ensure infections and outbreaks were detected, investigated and controlled; to ensure that the IPC Program reflected the scope and complexity of the hospital's services, was hospital-wide and unique to the hospital's environment, and evaluated the IPC Program on an ongoing basis and responded to changes; failure to ensure patient care items such as medications, patient care equipment and patient food items were handled, stored and maintained in accordance with nationally recognized standards and hospital P&Ps (Tag A-750); failure to ensure the IPC Program and P&Ps were consistent with nationally recognized guidelines including the appointment of an IP/IPs by the governing body with specialized training in infection prevention; failure to ensure IPC responsibilities of detection, investigation, monitoring and reporting requirements during an outbreak were followed; and failure by IP to audit and ensure staff adherence to IP P&Ps (Tag A-772); failure to ensure the IPC Program communicated and collaborated with QAPI on IPC issues. (Tag A-774); failure to ensure the IPC Program audited staff adherence to IPC P&Ps; and considered IPC responsibilities in adhering to nationally recognized guidelines including responses to breaches in IP practices, and ensuring mitigation strategies and required reporting for outbreaks were followed; failure to establish and implement a WMP that was consistent with nationally recognized standards (Tag A-776).

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29708

40575

PATIENT RIGHTS

Tag No.: A0115

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Based on observations, interviews, review of medical record documentation for 4 of 4 patients reviewed for restraints (Patients 8, 9, 15, and 22), review of incident documentation for 14 of 16 patients reviewed for investigation of incidents (Patients 1, 2, 3, 5, 6, 7, 8, 13, 16, 18, 19, 20, 22, and 23), review of grievance documentation for 10 of 10 patients reviewed for identification and response to grievances (Patients 1, 3, 6, 7, 13, 18, 24, 25, 26, and 27), and review of hospital P&Ps and other documentation it was determined that the hospital failed to protect and promote each patient's right to prompt and appropriate response to grievances, the right to privacy, the right to the provision of care in a safe setting, the right to freedom from all forms of abuse and neglect and timely and appropriate investigation of those allegations and other incidents, and the right to freedom from physical and chemical restraints. Those failures resulted in actual and potential physical and psychological harm to medically complex and vulnerable patients in the hospital.

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

Findings include:

1. Refer to the findings cited at Tag A-118 under CFR 482.13(a)(2) - Standard: Patient Grievances. Those findings reflected the hospital's failure to promptly identify, fully investigate, resolve, and provide clear and complete responses to patients' grievances, including allegations of abuse and neglect.

2. Refer to the findings cited at Tag A-122 under CFR 482.13(a)(2) - Standard: Patient Grievances. Those findings reflected the hospital's failure to ensure that complaint and grievance policies, procedures and logs clearly reflected required time frames for provision of written responses; and failure to ensure responses to grievances were in accordance with those.

3. Refer to the findings cited at Tag A-143 under CFR 482.13(c)(1) - Standard: Privacy and Safety. Those findings reflected the hospital's failure to ensure that patients were afforded personal privacy during the provision of care.

4. Refer to the findings cited at Tag A-144 under CFR 482.13(c)(2) - Standard: Privacy and Safety. Those findings reflected the hospital's failure to ensure the provision of care and services in a safe manner and in a safe environment. The hospital's failures contributed to patient harm and injury and created the likelihood of harm to other patients.

5. Refer to the findings cited at Tag A-145 under CFR 482.13(c)(3) - Standard: Privacy and Safety. Those findings reflected the hospital's failure to promptly and appropriately identify, investigate, and respond to allegations of abuse, and incidents that reflected potential neglect, that resulted in actual and potential patient harm. Investigations were unclear and incomplete and corrective actions plans to prevent recurrences had not been developed or implemented. Those failures contributed to patient harm and created the likelihood of harm to other patients.

6. Refer to the findings cited at Tag A-164 under CFR 482.13(e)(2) - Standard: Restraint or Seclusion. Those findings reflected the hospital's failure, prior to the application of physical or chemical restraints, to conduct comprehensive assessments of patients' needs for physical or chemical restraints, that included differentiation between those needed for non-violent, non-self destructive behavior and those needed for violent or self-destructive behavior, and that evaluated whether less restrictive or alternative interventions were effective.

7. Refer to the findings cited at Tag A-166 under CFR 482.13(e)(4) - Standard: Restraint or Seclusion. Those findings reflected the hospital's failure to ensure that restraint use and management were in accordance with clear and complete plans of care that were based on a comprehensive assessment.

8. Refer to the findings cited at Tag A-168 under CFR 482.13(e)(5) - Standard: Restraint or Seclusion. Those findings reflected the hospital's failure to ensure restraints were only applied under physicians' orders that were clear, complete, and patient-specific.

9. Refer to the findings cited at Tag A-171 under CFR 482.13(e)(8) - Standard: Restraint or Seclusion. Those findings reflected the hospital's failure to ensure that restraints used to manage violent or self-destructive behaviors were renewed at a maximum of every four hours for up to a total of 24 hours.

10. Refer to the findings cited at Tag A-175 under CFR 482.13(e)(10) - Standard: Restraint or Seclusion. Those findings reflected the hospital's failure to ensure that patients in restraints were appropriately observed and monitored; and failure to provide necessary care and services that ensured the safety and well-being of the patients.

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29708

40575

44104

QAPI

Tag No.: A0263

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Based on observations of 10 of 14 patients (Patients 15, 16, 17, 18, 19, 21, 22, 23, 28, and 31), interviews, review of medical record documentation for 16 of 23 patients whose records were reviewed for aspects of care and services (Patients 1, 2, 3, 4, 5, 6, 8, 9, 13, 15, 16, 17, 18, 21, 22, and 23), review of incident documentation for 14 of 16 patients reviewed for investigation of incidents (Patients 1, 2, 3, 5, 6, 7, 8, 13, 16, 18, 19, 20, 22, and 23), review of grievance documentation for 10 of 10 patients reviewed for identification and response to grievances (Patients 1, 3, 6, 7, 13, 18, 24, 25, 26, and 27), review of employee competency documentation for 2 of 2 employees (Former Employee 1 and Employee 2), and review of hospital P&Ps and other documentation it was determined that the governing body failed to ensure, through a hospital-wide QAPI program, the improvement of the hospital's care and services performance, and the prevention and reduction of adverse events through investigation, analysis of findings, and implementation of corrective actions to prevent recurrence.

The cumulative effect of these systemic failures resulted in this Condition-level deficiency that represents a limited capacity on the part of the hospital to provide safe and adequate care to the hospital's medically complex and vulnerable patients.

Findings include:

1. Refer to the findings cited at Condition Tag A-115 under CFR 482.13 - CoP: Patient's Rights. Those findings reflected the hospital's failure to ensure each patient's rights were protected and promoted. The hospital failed to promptly identify, fully investigate, resolve, and provide clear and complete responses to patients' grievances, including allegations of abuse and neglect (Tag A-118); failed to develop and implement clear time frames for the provision of written responses to grievances (Tag A-122); failed to ensure that patients were afforded personal privacy during the provision of care (Tag A-143); failed to ensure the provision of care and services in a safe manner and in a safe environment (Tag A-144); failed to promptly and appropriately identify, investigate, and respond to allegations of abuse, and incidents that reflected potential neglect, and to develop and implement corrective action plans to prevent recurrence (Tag A-145); failed to, prior to application of restraints, conduct comprehensive assessments of patients' needs for physical or chemical restraints, that included differentiation between those needed for non-violent, non-self destructive behavior and those needed for violent or self-destructive behavior, and that evaluated whether less restrictive or alternative interventions were effective (Tag A-164); failed to ensure that restraint use and management were in accordance with clear and complete plans of care that were based on a comprehensive assessment (Tag A-166); failed to ensure restraints were only applied under physicians' orders that were clear, complete, and patient-specific (Tag A-168); failed to ensure that restraints used to manage violent or self-destructive behaviors were renewed at a maximum of every four hours for up to a total of 24 hours (Tag A-171); and failed to appropriately observe and monitor the condition of patients in restraints, and provide necessary care and services to ensure the safety and well-being of the patients (A-175).

2. Refer to the findings cited at Condition Tag A-385 under CFR 482.23 - CoP: Nursing Services. Those findings reflected the hospital's failure to ensure an organized and effective nursing services. The hospital failed to ensure the RN conducted clear and complete nursing assessment of patients' individual physical and psychosocial problems and needs, that services were provided in accordance with clear and complete physician's orders, and that nursing services were coordinated with the other disciplines involved (Tag A-395); failed to ensure that the RN developed and implemented patients' plans of care that were clear, complete, individualized and coordinated with the other disciplines involved for the provision of safe and appropriate care and services (Tag A-396); and failed to ensure that RNs and LPNs administered and documented routine and PRN medications only in accordance with clear and complete physician's orders, patient-specific PRN indications, and P&Ps, evaluated and documented patients' responses to routine and PRN medications given, and reported to the physician and pharmacist concerns about orders, medication regimens, and patient's responses to medications (Tag A-405).

3. Refer to the findings cited at Condition Tag A-700 under CFR 482.41 - CoP: Physical Environment. Those findings reflect the hospital failed to maintain an environment that was clean and in good repair (A-701); failed to comply with the Life Safety From Fire requirements (A-709); and failed to develop and implement a preventive maintenance program that ensured biomedical and other equipment were maintained in accurate and safe working order (A-724).

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4. Refer to the findings cited at Condition Tag A-747 under CFR 482.42 - CoP: IPC and Antibiotic Stewardship Programs. Those findings reflect the hospital's failure to fully develop and implement an effective hospital-wide IPC Program and systems for surveillance, prevention, and control of HAIs and other infectious diseases including failure to identify an infection preventionist/infection control professional with specialized training in infection prevention, i.e., HAI surveillance, and who was responsible for the IPC Program; and failure to ensure the governing body appointed an infection preventionist/infection control professional based on medical and nursing leadership recommendations (Tag A-748); failure to conduct adequate and ongoing Risk Assessments in the areas of Infection Prevention, TB Infection Control, and healthcare Water Management; failure to ensure a clean and sanitary environment; to ensure infections and outbreaks were detected, investigated and controlled; to ensure that the IPC Program reflected the scope and complexity of the hospital's services, was hospital-wide and unique to the hospital's environment, and evaluated the IPC Program on an ongoing basis and responded to changes; failure to ensure patient care items such as medications, patient care equipment and patient food items were handled, stored and maintained in accordance with nationally recognized standards and hospital P&Ps (Tag A-750); failure to ensure the IPC Program and P&Ps were consistent with nationally recognized guidelines including the appointment of an IP/IPs by the governing body with specialized training in infection prevention; failure to ensure IPC responsibilities of detection, investigation, monitoring and reporting requirements during an outbreak were followed; and failure by IP to audit and ensure staff adherence to IP P&Ps (Tag A-772); failure to ensure the IPC Program communicated and collaborated with QAPI on IPC issues. (Tag A-774); failure to ensure the IPC Program audited staff adherence to IPC P&Ps; and considered IPC responsibilities in adhering to nationally recognized guidelines including responses to breaches in IP practices, and ensuring mitigation strategies and required reporting for outbreaks were followed; failure to establish and implement a WMP that was consistent with nationally recognized standards (Tag A-776).

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29708

40575

NURSING SERVICES

Tag No.: A0385

PHYSICAL ENVIRONMENT

Tag No.: A0700

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Based on observations, interviews, review of preventive maintenance documentation, review of manufacturer's instructions, review of hospital P&Ps, and review of other documentation it was determined that the hospital failed to ensure the physical environment was maintained and arranged to provide an EOC free of hazards and risks for its medically complex and vulnerable patients in a manner that complied with all Conditions of Participation. Failures included:
* Failure to ensure walls, flooring, furniture and other surfaces throughout the hospital were kept clean, in good repair, and maintained in a manner that ensured surfaces were cleanable.
* Failure to comply with the Life Safety From Fire requirements.
* Failure to develop and implement a preventive maintenance program that ensured biomedical equipment and other hospital appliances were maintained in safe working order.

The cumulative effect of these systemic failures resulted in this Condition-level deficiency that represents a limited capacity on the part of the hospital to provide safe and adequate care.

Findings include:

1. Refer to the findings cited under Tag A-701 at CFR 482.41(a) - Standard: Buildings. Those findings reflect that the hospital failed to ensure walls, flooring, furniture and other surfaces throughout the hospital were kept clean, in good repair, and maintained in a manner that ensured cleanable surfaces.

2. Refer to the findings cited at Tag A-709 under CFR 482.41(b) - Standard: Life Safety from Fire. Those findings reflect that the hospital failed to comply with the Life Safety From Fire requirements as indicated on the attached Fire Life Safety CMS 2567 SOD report.

3. Refer to the findings cited at Tag A-724 under CFR 482.41(d)(2) - Standard: Facilities. Those findings reflect that the hospital failed to develop and implement a preventive maintenance program that ensured biomedical equipment and other hospital appliances were maintained in accurate and safe working order.

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08621

40575

44104

INFECTION PREVENTION CONTROL ABX STEWARDSHIP

Tag No.: A0747

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Based on observations, interviews, review of medical record documentation for 2 of 2 patients, (Patients 8 and 9), review of employee competency documentation for 2 of 2 employees, (Former Employee 1 and Employee 2), review of infection control P&Ps, and other IPC Program documentation, it was determined the hospital failed to fully develop and implement an effective hospital-wide IPC Program and systems for surveillance, prevention, and control of HAIs and other infectious diseases. Processes and P&Ps for required disease reporting had not been fully developed, including a hospital policy which inaccurately required compliance with State of California reporting requirements for this hospital located in the State or Oregon. In addition, P&Ps based on nationally recognized standards for the surveillance, prevention, control of HAIs had not been fully developed and enforced. Failures included:
* Failure to conduct adequate hospital-wide Risk Assessments; the IC Risk Assessment, the TB Risk Assessment, and the Water Management Risk Assessment were inconsistent with nationally recognized guidelines and there was no evidence that the ICC had evaluated the IC or TB risk assessments in accordance with hospital P&Ps as an ICC had not been established.
* Failure to identify an infection preventionist/infection control professional qualified through experience, education, training or certification in infection prevention principles, including HAI surveillance, who was responsible for the IPC Program; and failure to ensure the governing body appointed an infection preventionist/infection control professional.
* Failure to ensure a clean and sanitary environment; to ensure infections and outbreaks were detected, investigated and controlled; to ensure that the IPC Program reflected the scope and complexity of the hospital's services, was hospital-wide and unique to the hospital's environment, and evaluated the IPC Program on an ongoing basis and responded to changes.
* Failure to ensure the IPC Program audited staff adherence to IP P&Ps; and considered IPC responsibilities in adhering to nationally recognized guidelines including responses to breaches in infection prevention practices and ensuring mitigation strategies for outbreaks were followed.
* Failure to ensure the IPC Program communicated and collaborated with QAPI on IPC issues.
* Failure to develop and implement a healthcare Water Management Program based on nationally recognized guidelines.

This Condition level deficiency represents failure to provide safe and adequate care.

Findings include:

1. A P&P titled, "Infection Prevention Surveillance" dated as last reviewed "01/2024" was reviewed and reflected:
* "Scope Organization Wide".
* "Reference CARF, TJC, CMS".
* "Policy: Surveillance is conducted to collect, analyze, and report infections of epidemiological significance to the facility."
* "Procedure ... Surveillance consists of the following ... Collection of data ... Determination of whether an infection is present (by use of criteria) ... Tabulation and consolidation of data ... Evaluation, analysis, and interpretation of data ... Dissemination of the above information to appropriate persons."
* "After analysis of the data, data should be used to plan infection prevention and control activities, detect outbreaks or epidemics, direct inservice education, and identify individual patient problems in need of intervention."
* "The surveillance system enables the hospital to analyze clusters and/or significant increases in the rate of infection."
* "Long-Term Acute Care Hospitals are required to report the following to NHSN ... Any additional reporting required by local or state regulations".
* "Surveillance: Disease Reporting ... Vibra Hospital reports any suspected or confirmed communicable diseases to the local/state health department ... The IP is responsible for complying with the state health departments [sic] regulations for Modifiable Diseases and Reportable conditions ... Healthcare workers are mandated to report, in writing, all diagnosed or presumptive case specified communicable and occupational disease designated by the State."
* "Surveillance: Noticeable Conditions ... Vibra Hospital reports any suspected or confirmed communicable diseases to the local/state health department and any specific reportable diseases for the state health department... The IP is responsible for complying with the State Department of State Health Services regulations for Notifiable Diseases and Reportable conditions ... Healthcare workers are mandated to report, in writing, all diagnosed or presumptive case specified communicable and occupational disease designated by the State Department of Health ... Specific forms are utilized according to the State Department of Health, which can be obtained by calling the local or state health department, see below."
* "Related Documents: California Surveillance State Addendum ... National Healthcare Safety Network Patient Safety Component Manual".

The hospital failed to fully implement its Infection Prevention Surveillance P&P. There was no documentation that the hospital complied with "State Department of State Health Services regulations for Notifiable Diseases and Reportable conditions" and reported suspected outbreaks or reportable diseases in accordance with the hospital's "Infection Prevention Surveillance" P&P, its "Outbreak Investigation" P&P, or State of Oregon OARs for disease reporting requirements. Refer to Tag A-774, Findings 1 and 2, IP and QA meeting minutes for 2023 which lacked documentation of reported IP conditions, and Finding 5 below, State of Oregon reporting rules. It was unclear whether the policy was hospital-specific or whether it addressed disease reporting requirements for California as the "Related Documents" referenced a "California Surveillance State Addendum".

2. Refer to the findings cited under Tag A-748 at CFR 482.42(a)(1) - Standard: Infection Prevention and Control Program, Organization and Policies that reflects the hospital failed to identify an infection preventionist(s)/infection control professional(s) who was qualified through experience, education, training or certification in infection prevention principles, and the governing body failed to appoint an infection preventionist(s)/infection control professional(s) responsible for the IPC Program.

3. Refer to the findings cited at Tag A-750 under CFR 482.42(a)(3) - Standard: Infection Prevention and Control Program, Organization and Policies that reflects the hospital failed to thoroughly assess the hospital's IC risks, including risks associated with its WMP; failed to develop and implement an IP Program, including IP P&Ps, that considered and addressed IP issues unique to the hospital's environment; failed to ensure that infections and outbreaks were detected, investigated and controlled; failed to ensure a clean and sanitary environment, and failed to ensure that single-dose medications, and patient care equipment, such as tracheostomy condensation drainage bags and urinary catheter drainage bags were handled and maintained in accordance with nationally recognized standards.

4. Refer to the findings cited at Tag A-772 under CFR 482.42 - (c)(2)(i) - Standard: Leadership Responsibilities that reflects the hospital failed to ensure the hospital had designated an IP who had specialized training in infection prevention and control; failed to ensure that IP P&Ps were specific to the hospital and state in which the hospital was located; failed to ensure IP responsibilities for detection, investigation, monitoring and reporting requirements for HAIs, including outbreaks, were consistent with nationally recognized standards; failed to develop a WMP that was consistent with nationally recognized standards; failed to ensure P&Ps to maintain a clean and sanitary environment which mitigated the risk of infection for patients were implemented and adhered to by hospital personnel.

5. Refer to the findings cited at Tag A-774 under CFR 482.42(c)(2)(iii) - Standard: Leadership Responsibilities that reflects the hospital failed to ensure the IPC Program communicated and collaborated with QAPI on IPC issues.

6. Refer to the findings cited at Tag A-776 under CFR 482.42(c)(2)(v) - Standard: Leadership Responsibilities that reflects the hospital failed to ensure the IPC Program audited staff adherence to IPC P&Ps during patient care, and in the maintenance and storage of patient care equipment, food, and medications; failed to ensure that IPC responsibilities in adhering to nationally recognized guidelines regarding mitigation strategies for outbreaks, including required outbreak reporting, were followed in accordance with the hospital's P&Ps and state reporting requirements; and failure to establish a Water Management Program that was consistent with nationally recognized standards.

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29708

40575

PATIENT RIGHTS: GRIEVANCES

Tag No.: A0118

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Based on interview and review of grievance, incident, and medical record documentation for 6 of 6 patients who were reviewed for grievances and abuse allegations (Patients 1, 3, 6, 7, 13, and 18), it was determined that the hospital failed to promote and protect patient's rights for prompt resolution of patient grievances, including allegations of abuse and neglect for the hospital's medically complex and vulnerable patients.
* Responses to grievances filed were unclear and incomplete.
* All allegations of abuse and neglect had not been documented, identified on the grievance log, nor investigated and responded to as a grievance.

Interpretive guidelines under this CFR Tag stipulate that "All verbal or written complaints regarding abuse, neglect, patient harm or hospital compliance with CMS requirements, are considered a grievance for the purposes of these requirements."

Findings include:

1. For Patient 1 refer to the Findings cited under Tag A-145 regarding the hospital's deficient investigation and grievance response to allegations of patient abuse.

2. For Patient 3 refer to the Findings cited under Tag A-145 regarding the hospital's deficient investigation and grievance response to allegations of "multiple incidents, medication errors, negligent [sic], and [staff] did sedate [patient] with medication." The grievance/incident allegations also included that the patient had been found with "Dried feces" on them on "multiple occasions," that staff did not provide incontinence care and bathing, and "[Family does] all [patient's] care besides give [them their] medication."

3. For Patient 6 refer to the Findings cited under Tag A-145 regarding the hospital's deficient investigation and grievance response to allegations that the patient received "rough care" and that excessively hot water was used during a shower.

4. For Patient 7 refer to the Findings cited under Tag A-145 regarding the hospital's deficient investigation and grievance response to allegations of sexual assault.

5. For Patient 13 refer to the Findings cited under Tag A-145 regarding the hospital's deficient investigation and grievance response to allegations that staff broke the patient's arm.

6.a. For Patient 18, on 11/14/2024, beginning at 0950, a follow up interview was conducted with Patient 18 regarding a verbal complaint made to the surveyor on 11/12/2024 about patient care concerns. Patient 18 stated that on 11/11/2024, during the NOC shift at approximately 0300, the RN responsible for Patient 18's direct care "yelled" at them. Patient 18 was so bothered by the nurse yelling at them that they told their spouse and the oncoming day shift nurse about the incident. The patient was asked whether they had filed a formal grievance or complaint about the occurrence and they replied "No." The IDON was in the room at the time Patient 18 described the incident and the surveyor asked the IDON if they would follow up on the patient's grievance and the IDON stated that they would do so.

6.b. During the survey, reviews of incident reports and grievances by other survey team members reflected that there were no incident reports, grievance documentation or investigation follow up for the above incident involving Patient 18.

6.c. On 11/19/2024, just prior to the Exit Conference, the surveyor asked the IDON whether they had followed up on Patient 18's complaint. The IDON stated that they had forgotten to do so and had not filed an incident report or grievance on behalf of the patient.
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44104

PATIENT RIGHTS: GRIEVANCE REVIEW TIME FRAMES

Tag No.: A0122

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Based on interview, review of grievance documentation for 4 of 4 patients (Patients 24, 25, 26 and 27), review of policies and procedures, and review of grievance log documentation it was determined the hospital failed to to ensure patients' rights were recognized, protected, and promoted as follows:
* Complaint and grievance policies, procedures and logs were unclear and lacked clear time frames for provision of a written response.

Findings included:

1. The P&P titled "Complaint and Grievance Process" dated last revised "2/19" was reviewed and reflected:
* "Vibra Hospital attempts to resolve all grievances internally as soon as possible. Most grievances should be resolved within seven days. A written response is sent to the complainant upon resolution of the grievance. For complex, grievances that require deeper investigation or resolution of systematic problems, a longer timeframe may be necessary as determined by hospital administration, usually no longer than 30 days. In this instance, the complainant is notified that administration is still working on the resolution and will follow-up with a written response within a stated number of days."
* "Upon receipt of Patient Complaint ... If the complaint is satisfactorily resolved and not considered a grievance, enter complaint into the complaint Log ... If complaint is designated as unresolved, or qualifies as a grievance, implement actions and interventions to investigate ... Initiate Grievance Investigation and Resolution form ..."
* "Completing Grievance Investigation and Resolution form ... Ensure documentation of the grievance in the Grievance Log."

The P&P was not clear regarding the number of days from the date a grievance was received to the date the hospital would send the patient or patient's representative a written response. For example, the P&P reflected:
* "Most grievances should be resolved within seven days. A written response is sent to the complainant upon resolution of the grievance." This did not clearly describe the number of days from the date a grievance was received by the hospital to the date the hospital would ensure the patient or patient's representative had been sent an initial written response by the hospital.
* "For complex, grievances that require deeper investigation or resolution of systematic problems, a longer timeframe may be necessary as determined by hospital administration, usually no longer than 30 days. In this instance, the complainant is notified that administration is still working on the resolution and will follow-up with a written response within a stated number of days." The P&P was not clear when the hospital would notify the patient or patient's representative that administration was still working on the investigation or resolution. It was not clear whether the hospital would notify the patient or patient's representative verbally or in a writing.
* The P&P referred to complaint and grievance logs. However, the P&P did not specify the information that would be documented on the logs.

2. An untitled log provided in response to a request for the hospital's list/log of all patient complaints/grievances for the last three months was provided. The log had 15 columns with headings that included "Date", "[Patient] Name", "[Length of Stay]", "[Verbal] or [Written]", "Complaint, [Grievance] or [Property] Loss", "Description of Complaint", "DQM Rec", "CCO Rec", "CEO Rec", "Written Response Required?", "[Meeting] Date", "Date Letter Mailed", and "Notes". The log was not clear regarding when complaints and grievances were initially received by the hospital. For example, although the log included a "Date" column, it was not clear what that "Date" represented. The log had no column or other information that described when complaints and grievances were initially received by the hospital. Without a clearly identified received date, it was not evident when the hospital should submit the patient or patient's representative a written response.

2.a. Regarding Patient 24, the log reflected a verbal complaint regarding staff communication during medication administration. "Date", "DQM Rec", and "CCO Rec", each reflected 01/17/2024. "CEO Rec" was blank. "Written Response Required?" reflected "Yes". "Date Letter Mailed" reflected "1/29 Sent to [name] for letterhead and [name] [for] approval". The log was not clear when the written response was "mailed" or otherwise provided to the patient or patient's representative. The log was not clear regarding when the complaint was initially received by the hospital.

2.b. Regarding Patient 25, the log reflected a verbal grievance regarding physical therapy and occupational therapy services. "Date" reflected "03/23/2024, "DQM Rec" reflected 03/26/2024, "CCO Rec" reflected 03/25/2024, "CEO Rec" reflected "came from CEO". "Written Response Required?" reflected "Yes". "Date Letter Mailed" reflected "Sent to [name] to send; [name] [has] already reviewed, to sign". The log was not clear when the written response was "mailed" or otherwise provided to the patient or patient's representative. The log was not clear regarding when the grievance was initially received by the hospital.

2.c. Regarding Patient 26, the log reflected a verbal grievance regarding "care delivery", restraint assessments and an allegation of verbal abuse. "Date", "DQM Rec", "CCO Rec" each reflected "04/03/2024. "CEO Rec" reflected "04/02/2024". "Written Response Required?" reflected "Yes". "Date Letter Mailed" reflected "4.4 sent to [initials] for review. [Hand] delivered to patient". The log was not clear regarding the date the grievance was initially received by the hospital.

2.d. Regarding Patient 27, the log reflected a written grievance regarding air conditioning. "Date", "DQM Rec", "CCO Rec" and "CEO Rec" each reflected "09/03/2024. "Written Response Required?" reflected "Yes". "Date Letter Mailed" reflected "letter hand delivered 9/11". The log was not clear regarding the date the grievance was initially received by the hospital. For example, it was not clear if the grievance was initially received by the hospital on 09/03/2024 or before that date.

3. During interview on 10/14/2024 at 1045 the CCO reviewed the P&P titled "Complaint and Grievance Process" and the complaint and grievance log. The CCO acknowledged they were not clear. The CCO stated they did not know what date the "Date" column represented on the complaint and grievance log.

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PATIENT RIGHTS: PERSONAL PRIVACY

Tag No.: A0143

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Based on observations of 1 of 1 patient for personal privacy (Patient 22), and review of policies and procedures it was determined the hospital failed to ensure patients' rights were recognized, protected, and promoted as follows:
* A patient's genitals, buttocks, and abdomen were exposed during personal care without staff efforts to provide personal privacy.

Findings include:

1. Refer to Tag A-395 for details regarding the lack of personal privacy for Patient 22.

2. The P&P titled "Plan of Provision of Care" dated last revised "March 2023" reflected "Patient Rights and Organizational Ethics ... The hospital respects the rights of patients, recognizes that each patient is an individual with unique health care needs, and because of the importance of respecting each patient's personal dignity, provides considerate, respectful care ..."

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PATIENT RIGHTS: CARE IN SAFE SETTING

Tag No.: A0144

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Based on observations, interviews, review of incident and medical record documentation for 14 of 16 patients reviewed for incidents (Patients 1, 2, 3, 5, 6, 7, 8, 13, 16, 18, 19, 20, 22, and 23), and 2 of 6 patients reviewed for accessible call lights (Patients 15 and 22), review of P&Ps, and review of internal investigation documentation, it was determined that the hospital failed to fully develop and implement P&Ps that ensured each patient's right to receive care in a safe setting. The hospital's failures contributed to patient harm and created the likelihood of harm to other medically complex and vulnerable patients. Those failures included
* Failure to provide provide safe and appropriate care that prevented patient injury and harm. Patient 13's contracted arm was fractured by staff during repositioning in bed.
* Failure to provide safe and appropriate care and treatment in response to patient injury and harm. Initial evaluation of the injury, stabilization, treatment, and further orthopedic evaluation were not provided timely for Patient 13.
* Failure to thoroughly investigate incidents and adverse events for Patient 13 and other patients, and to implement corrective actions to prevent recurrence.
* Failure to ensure call light devices were accessible to patients to notify staff of urgent and immediate problems and needs.

Findings include:

1.a. Regarding Patient 13: The review of incident and medical record documentation revealed that care provided to Patient 13 was not safe and resulted in a fractured humerus bone, an injury of physical harm. Further the subsequent response to the injury was not timely and unclear. For example:
* On 12/12/2023 the patient's left humerus was fractured while the patient was being repositioned in bed on the day of discharge. A delay in response to the witnessed injury that was caused by staff resulted initially when the patient and family were reportedly told the hospital would not be able to take X-rays and they would have to proceed with discharge from the facility and then go to an ER for x-rays on their own.
* An X-ray was not taken until the following day on 12/13/2023 at which time a fracture was diagnosed, and an order was placed for "Stat ... Please send a referral for the patient to see [an Orthopedic surgeon] ASAP."
* A CT was not taken until the patient was transported to a nearby acute care hospital on 12/14/2024 at which time the fracture, already identified on X-ray, was confirmed.
* There were no physicians orders for care or immobilization of the patient's fractured extremity until 12/15/2023 at which time a sling was ordered.
* The patient was sent to an orthopedic clinic on 12/15/2023, however, the hospital failed to arrange for Vibra staff to accompany this fully dependent, immobile, and uncommunicative hospital patient to the clinic. The patient was transported by ambulance and they had no one to be in attendance with them at the clinic. The clinic was unable to provide services under those conditions and returned the patient to the facility without evaluating the patient. That significantly delayed the ordered orthopedic evaluation as another visit was not scheduled and did not occur for five more days until 12/20/2023.
* The sling ordered on 12/15/2023 was not carried out for four days as the sling was documented as "ripped" or "broken" or "non-functional" beginning at the start of the 12/15/2023 night shift and the hospital did not provide a new replacement sling.
* The patient's care plan was incomplete, did not identify the patient's problems of immobility and contracture of the left upper extremity, and was not updated after the injury to reflect a problem of an actual fracture with appropriate interventions to ensure appropriate and timely care and services.
* An investigation of how and why the fracture occurred was not conducted to identify gaps and opportunities for improvement, and implementation of corrective actions to prevent recurrence of harm for Patient 13 and other patients.

1.b. Review of the medical record for Patient 13 revealed the following information:
* Patient 13's medical record "Facesheet" reflected they were admitted to the hospital from another facility on 11/09/2023 at 1826 and were discharged to home on 12/22/2023 at 1645.
* On 12/11/2023 at 0923 a CM signed a "Interdisciplinary Discharge Instructions" form that reflected the patient was scheduled for discharge to home with Home Health Care and Home Infusion Services on 12/12/2023 at 1200.
* On 12/12/2023 at 1922 an RN signed a nursing note that reflected "... Pt discharge paperwork and education complete and pt [family] came to pick pt up at approximately 1800 ... Pt [family] observed while changing the pt and preparing [patient] for discharge that the pt's arm looked different than [their] baseline, and pt [family] voiced concern about the possibility of injury and requested that the pt receive imaging before transferring. Assigned [RN 3] and [this RN] called [MD] prior to 1900, however, no response at this time. RN's sought house supervisor advice with regards to the concerns, and the
house supervisor called and got a hold of the [MD] who advised that the pt stays and gets imaging before discharge. Discharge canceled for today. Pt environment left safe, bed locked and in lowest position, door open for observation. Pt mother updated about the new plan by house supervisor." There was no documentation by the "Assigned [RN 3]" about the provision of care to Patient 13.
* On 12/12/2023 at 1958 an RN signed a nursing note that reflected "contacted [MD], and explained the [family's] concern in regards to possible shoulder dislocation. Order for left shoulder xray received."
* On 12/13/2023 at 0450 an RN signed a nursing note that reflected "Pt alert, agitated, VSS, has low grade fever, repositioned, looks [like they are] in pain / distress, notified HS, got orders for Norco and lorazepam po prn's, [the patient's] IV line was removed yesterday, suctioned couple time [sic] c/o of left shoulder pain, monitored [patient] clossely [sic]."
* On 12/13/2023 at 1058 a CM signed a note that reflected: "Received the following messages from pt's [family] while [they were] at Vibra to pick pt up for [discharge]: 'I think [RN 3] dislocated [Patient 13's] left shoulder by forcing [their] arm down. I was told I would have to take [Patient 13] to the ER for an x-ray. I'm currently waiting for the [House Supervisor] to come talk to me. [Patient 13] is staying until [they get] an x-ray and we see what's going on with [their] shoulder.'" The note reflected the CM reported the information to the hospital CEO and the DON. The CM called [Patient 13's] family regarding "the situation that occurred on the evening of 12/12 when [family] came to pick pt up for [discharge]" and the family provided the following: "pt needing to be changed prior to [discharge] home. [RN 3] and CNA were changing pt's brief and during this process [RN 3] pulled pt's arm down (this arm is typically bent up near pt's head at baseline) and then rolled pt over onto [their] arm. At this point pt grimaced in pain (pt is non-verbal so unable to express pain vocally). After this incident [family] attempted to put pt's arm back up to resting position near pt's head three times and each time arm fell back down. after this [family] verbalized concern for dislocation and requested an x-ray. RN called house supervisor to inquire about x-ray and was told that pt needed to [discharge] regardless and if [family] wanted an x-ray then [they] should take pt to ER to get one. [Family] refused to transport pt in current state and take [patient] for [discharge] or to ER and was adamantly requesting an x-ray be taken at Vibra. [Family] requested to speak to house supervisor. House supervisor then came to bedside to discuss with [family]. House supervisor then called [MD] to request x-ray and an x-ray order was put in. [Family] was told x-ray would likely not occur until the morning. [Family] was ok with this." The note reflected "This account of events was shared with [DON] so that it can be followed up on with clinical parties involved. Received a message from pt's [family] stating there is concern about pt's muscles as well which will not be shown on an x-ray. Further imaging requested by [Patient 13's family]. I contacted [MD] to request a CT order be placed for pt." There was no documentation by RN 3 about the provision of care to Patient 13.
* On 12/13/2023 at 1525 a DO signed a Radiology Report of an X-ray of the patient's left shoulder that had been taken on 12/13/2023. The report reflected "Acute impacted proximal humerus fracture with comminution and mild displacement seen ... Acute impacted proximal humeral fracture."
* On 12/14/2023 at 0406 an MD signed a Radiology Report of an X-ray of the patient's left shoulder that had been taken on 12/13/2023. The report reflected "There is a fracture involving humeral head with minimal displacement ... Acute humeral fracture as described above."
* On 12/14/2023 at 0641 an RN signed a note that reflected "... CT of left upper extremity today at Adventist Radiology, ensured safety sent to the ambulance with VSS ..."
* On 12/14/2023 at 0723 an MD signed a CT Imaging Report of the patient's left upper extremity that was conducted at an acute hospital. The report reflected "Bones: Acute appearing comminuted and impacted proximal humeral fracture. There is involvement of the greater and lesser tuberosity. Joints: No dislocation. Moderate joint effusion ..."
* On 12/14/2023 at 1235 a CM signed a note that reflected "[Patient 13] has [outpatient appointment at orthopedics clinic] today."
* On 12/14/2023 at 1549 an MD signed a note that reflected "... [left] shoulder ... x-ray ordered which showed impact fracture with minimal displacement ... Referred to Ortho on 12/13 with an appointment scheduled for 12/15 -follow up with Oregon Clinic Ortho on 12/15 -place L arm in a sling for comfort -Norco PRN for pain."
* On 12/15/2023 at 1000 an MD ordered "Patient Care Order Daily, Request Type: Routine, Comments: Please place and keep Pt's L arm in a sling for [their] fractured humerus." The order was "discontinued" on 12/22/2023 at 1645, the date of the patient's discharge.
* Sling "Administration History" reflected that the sling was documented as applied for the first time on 12/15/2023 at 1019.
* On 12/15/2023 at 1900 an RN signed a note that reflected "Pt. transported for 'ortho evaluation' of L humerus Fx @ about 1400. Received information from [orthopedics clinic] about 1500 that pt. was being sent back and no treatment would be performed because pt. is unable to consent for [themselves] and was unaccompanied. House supervisor notified. Spoke with case manager and [unit secretary] who made the appointment. Repeat follow-up appointment was made for Wednesday. Case manager stated [they] will contact the family regarding future appointment. Pt. returned @ 1415 in no acute distress. Sling in place per md order."
* On 12/16/2023 at 0657 an LPN signed a note that reflected "Received patient with left arm sling off, found sling and it is ripped. House supervisor aware and will pass down to dayshift."
* On 12/16/2023 at 2116 an MD signed a note that reflected "Placed L arm in a sling for comfort, the sling is broken, will communicate with the team, try to fix it or get a new one."
* On 12/16/2023 at 1841 an RN signed a note that reflected "Received patient with left arm sling off, sling is nonfunctional, waiting for the therapy to evaluate and provide a new one. found sling and it is ripped. House supervisor aware and will pass down to dayshift."
* On 12/17/2023 at 0812 an LPN signed a note that reflected "Received patient with left arm sling off, it is ripped as of 12/15."
* On 12/17/2023 at 1750 [RN 3] signed a note that reflected "SLING OFF DUE TO NOT FUNCTIONAL. MD AWARED [sic]." That was the only entry in the medical record by RN 3 in regard to this incident for Patient 13.
* On 12/19/2023 at 1412 a CM signed a note that reflected "Pt has [orthopedics clinic appointment] on 12/20. [Orthopedic doctors] are requesting that one of pt's [family] be present at appt so that consents can be signed. Spoke with pt's [family] ... Time, date, and address have been provided ..."
* On 12/19/2023 at 1523 an MD signed a note that reflected "Placed L arm in a sling for comfort , the sling is broken, PT thinks it is not really helpful due to [the patient's] arm position."
* On 12/20/2023 at 1449 an MD signed an Orthopedics office visit report that identified the "Location of Care" as "The Oregon Clinic." The report included the following information: "[Patient 13] who is nonverbal and has a tracheostomy tube presents with [their family] who was the historian. Last week a nurse turned [the patient] in an aggressive fashion and injured [the patient's] arm ... [the patient] usually holds [their] arm up over [their] head at [their] resting position, since this injury, the arm has been at the patient's side. The patient does not seem to feel pain. [They] had an x-ray and CT and told to follow-up here." The report identified also for the "Left upper extremity: Flexion contracture of the elbow. No discomfort notes with small movements of the shoulder." After review of the X-ray and CT imaging the MD wrote "Plan Recommendations: I recommend observation as the patient's diagnosis and arm position makes it difficult for immobilization of the shoulder. I reassured the [family] that the fracture should heal within 6 to 8 weeks. Hopefully the patient will be able to raise [their] arm as previously. If [the patient] continues to have problems I will see [them] back."
* On 12/20/2023 at 1806 an LPN signed a note that reflected "... was [out of facility] for Ortho appt [pick up] at 1245. no new order received, resident back to the campus , VSS."
* On 12/21/2023 at 1139 a CM signed a note that reflected "Spoke with pt's [family] and [they stated orthopedic doctor at the 12/20/2023 appt. okayed the patient] for dc from hospital, stating the fx will likely heal on it's own and [family] should monitor pt for the coming 6-8wks. d/t pt's tendency to keep arm over head it is difficult to immobilize, so plan is to observe pt and schedule a [follow up] if needed. contacted [orthopedic clinic] office and the doctor's note from appt yesterday has been faxed to vibra and uploaded into document storage. Pt is cleared for dc. plan will be for pt's [family] to pick [patient] up for discharge on Friday 12/22 at ~1430."
* On 12/21/2023 at 1730 an MD signed a note that reflected "[Patient] had an appt with [Orthopedic MD], consult note obtained, recommend observation. The fracture should be heal [sic] within 6 to 8 weeks. [Orthopedic MD] will follow the patient as needed - Will discharge with SC Heparin for DVT prophylaxis."
* On 12/22/2023 at 2027 an RN signed a note that reflected "Assumed care at 07:30. VSS ... Pt discharged home w/ family at 16:40. [Family] in pleasant mood and thanked staff."
* Review of Patient 13's "Plan of Care - Complete Plan" revealed that it addressed only two patient problems. Those were "Alteration in Skin Integrity related to identified pressure injury ..." that was dated 11/10/2023, and "Alteration in Communication related to impaired ability to speak ..." that was dated 11/25/2023. There were no other problems including those evident such as the patient's tracheostomy, limited mobility, impaired range of motion, flexion contracture of the left elbow that required special interventions during movement and positioning to prevent injury, etc. Further, the care plan had not been updated at the time of incident to reflect a new fracture and interventions to prevent further injury and promote healing.

1.c. Review of incident documentation initiated on 12/13/2023 at 1400 for Patient 13 revealed the incident occurred on 12/12/2023 at 1845. It contained the following information:
* The "Incident Description" was documented as follows: "'Received] email from [Vibra CM] with the following information. [CM] could not enter [Incident Report]. DQM entered [Incident Report] on [their] behalf. Received the following messages from pt's [parent] while [they were] at Vibra to pick pt up for dc: 'I think [RN 3] dislocated [Patient 13's] left shoulder by forcing [their] arm down. I was told I would have to take [the patient] to the ER for an x-ray. I'm currently waiting for the supervisor to come talk to me. [Patient 13] is staying until [they get] an x-ray and we see what's going on with [their] shoulder.' Brought this information to [CEO and DON] who both state they were not informed that this situation occurred last evening. Called pt's [parent], with [CEO] to discuss. The following is [the parent's] account of the situation that occurred on the evening of 12/12 when [they] came to pick pt up for dc: pt needing to be changed prior to dc home. [RN 3] and CNA were changing pt's brief and during this process [RN 3] pulled pt's arm down (this arm is typically bent up near pt's head at baseline) and then rolled pt over onto her arm. At this point pt grimaced in pain (pt is non-verbal so unable to express pain vocally). After this incident [parent] attempted to put pt's arm back up to resting position near pt's head three times and each time arm fell back down. after this [parent] verbalized concern for dislocation and requested an x-ray. RN called house supervisor to inquire about x-ray and was told that pt needed to dc regardless and if [parent] wanted an x-ray then [they] should take pt to ER to get one. [Parent] refused to transport pt in current state and take [them] for dc or to ER and adamantly requesting an x-ray be taken at Vibra. [Parent] requested to speak to house supervisor. House supervisor then came to bedside to discuss with [parent]. House supervisor then called [MD] to request x-ray and an x-ray order was put in. [Parent] was told x-ray would likely not occur until the morning. [Parent] was ok with this. This account of events was shared with [DON] so that it can be followed up on with clinical partied involved."
* The "Incident Type Information," "Nature of Injury," and "Incident Action Plan" sections of the electronic form were not completed.
* The "Incident FollowUp" reflected only "Interviews have been completed by DON with involved staff. I would like to do a RCA." That was dated 12/13/2023 at 1400. However, it was not evident who was interviewed and what information about the incident was obtained during the interviews.
* The "Assessment" section reflected the "Incident Status" was "Complete" and reflected the following: "DC canceled. CT and xray ordered. 12/13 DQM spoke with [CEO] re: incident. CEO spoke with patient's [family]. [CEO] stated the patient's [family] does not think abuse was involved. CEO stated conversation will be had with nursing supervisor who told the [family] to take the pt to an ER for x-ray. Awaiting status of patient from DON and/or CCO. [12/28/2023] No follow up pt status provided. DQM reviewed chart. Per [MD's] note: Pt saw ortho on 12/20. Per ortho, no intervention required at this time. Should heal within 6-8 weeks. Pt arm placed in sling. CCO indicates [they'd] like to do an RCA. Unsure if this is scheduled as yet."
* The "Recommendations" were recorded as "[MD] notified and x-ray ordered. [Discharge] was cancelled."

1.d. No other incident investigation was provided to reflect that a complete and thorough investigation had been conducted to identify gaps and opportunities for improvement, to include for example:
* Review of the patient's medical record and care plan for assessment and interventions information related to the patient's left arm range of motion, contracture, mobility/movement, and positioning prior to the incident. It should have been identified that there was no assessment or care plan related to the patient's contracture.
* Review of the medical record documentation by RN 3 regarding the provision of care to Patient 13 on 12/12/2023. It should have been identified that there were no notes or documentation by RN 3 about care provided to the patient on 12/12/2023.
* Evaluation of the qualifications and competencies, and onboarding and training, of RN 3 who had positioned Patient 13's arm that resulted in the fracture.
* Observation of RN 3's techniques for positioning dependent patients with contractures.
* Review of RN 3's personnel records to determine if other care concerns had been raised.
* Review of applicable hospital policies and procedures to determine if those had been followed. For example: management of contracture's, re-positioning of dependent patients, care planning, transport of dependent hospital patients to community outpatient services, and provision of medical supplies/devices such as slings.
* Interviews with staff including RN 3, the CNA in the room, any other staff in the room, the Charge Nurse, the House Supervisor and other applicable persons..

1.e During interview with the CCO and CMD at the time of review of this incident on 11/20/2024 beginning at 0900 they confirmed the medical record and incident investigation findings including related to the timeline of events, the lack of timely and appropriate response, the delays in the orthopedic evaluation due to failure of staff to meet the patient needs for the orthopedic visit, the lack of appropriate response to the damaged sling, the lack of a care plan, lack of an investigation in to how the injury fracture occurred, etc., and they provided the following additional information:
* There was no additional investigation information documented.
* They recalled that the DON at the time did a "full investigation" and interviewed staff involved but that the "notepad of handwritten notes" could not be found.
* They stated that after the staff interviews the DON had reportedly said "there was no malicious intent."
* They stated there was no disciplinary action of staff taken as result of the incident.
* They stated that no training of staff was conducted as result of the incident.
* They stated that further investigation, including the RCA, did not occur.

1.f. In an email received from the CCO on 11/25/2024 at 1004 they wrote that they had found additional investigation information for Patient 13. The email contained a short email string from the former DON who sent an email to the CCO on 11/20/2024 and 11/22/2024, under a signature block that identified themselves as the current DON contrary to information provided during the survey.

Attached to the email was a screenshot of the former DONs Word documents list on their computer that reflected a document titled "242 fracture" was last saved on 12/14/2023 at 1533. The second attachment to the email was a one-half page, untitled and undated Word document that contained the following information: "Tuesday evening (12/12/24) around 1830-1840 patient in [Room] 242 was ready for discharge. [RN 3] and [a CNA] were getting the patient ready to go. Patient had a bowel movement and needed personal care to be provided. As the patient was being turned, patient's [family who was present] reported [RN 3] pulled the patients left arm in a down position (baseline, patients [sic] arm is contracted in an upward way. Patient's family refers to it as a chicken wing) and then turned the patient onto the arm. Patient's [family] reported patient let out a scream (patient is nonverbal at baseline) and winced in pain. Immediately patient's [family] stated something was not right with the arm. [They] tried to help the patient place the arm in the upright position and the patient again winced. [Night Nursing Supervisor] went to patient room to speak with the [family] of patient in 242. Patient's [family] was concerned about patient's shoulder and not wanting to discharge. [Family] stated that [RN 3] had told [the family] that the patient needed to discharge and [the family] could take the patient to an ED for an x-ray since we would not be able to process an x-ray until the next morning. [RN 3] was concerned about the shoulder. [Nursing Supervisor] paged the [MD] and explained what had happened. Received a verbal order for a shoulder x-ray. [Nursing Supervisor] went back to the [family] and explained we did get an order but we don't have overnight x-ray and so one would be taken tomorrow. [Family] was in agreement with the plan. [RN 3] also noted that [they] had noticed a change in the shoulder either the previous Sunday or Monday since [they] had [Patient 13] as a patient for the last 3 days. [RN 3] could not remember which day exactly [they] noticed the change. [The CNA in the room at the time of the incident] was not the CNA for this patient but assisted [RN 3] with helping the patient at that time. [That CNA] stated the arm was down when [the CNA] came in to the room to help [RN 3] and not in the normal position. [The portable x-ray provider] came onsite at approximately 1630 [on 12/13/2023] to take the x-ray where it showed a possible proximal humorous [sic] fracture. Patient went for further imaging today, 12/14/23 (CT scan)."

That was the extent of the information and did not constitute an investigation.

2. Refer to Tag A-145 for Patients 1, 2, 3, 5, 6, 7, 8, 16, 18, 19, 20, 22, and 23 that reflects the provision of safe care for all patients had not been ensured as incidents and allegations of potential abuse and neglect had not been thoroughly investigated, gaps and opportunities for improvement had not been identified, and corrective actions to prevent recurrence that were based on a thorough investigation had not been planned or implemented.

44104

3. The P&P titled, "Call Light Devices for Patients," dated last reviewed "12/23" included "Appropriate devices shall be available to help facilitate patient communication needs ... Minimally every two hours, the staff shall: Verify that the patient's call device is easily accessible to him/her.

4. During a tour of the high-acuity medical unit on 11/13/2024, at 1353, Patient 15 was observed moving and crying out while lying in their bed and all four bed railings were raised. The patient's call light was observed hanging out of reach of the patient to the right and above their head on a vital signs machine. A strong odor of feces was apparent upon entering the room. The RTM located the patient's RN and apprised them of the patient needing personal care at approximately 1354. At 1413, another RN passed by Patient 15's room and entered Patient 15's room. That RN called for assistance and personal care was provided for Patient 15 after approximately 20 minutes. Patient 15's RN was not observed responding to the RTM's request to assist Patient 15. This was verified by the RTM at the time of the observation.

29708

5.a. Observations of Patient 22 on 11/13/2024 beginning at 1040 with IDON revealed:
* The patient was in bed in supine position with bilateral hand mitts and tracheostomy. The bed had four side rails in the raised position. Observation of care provided by an RN and CNA revealed the patient was dependent for personal care and repositioning.
* A call light pad device was observed on the mattress near the right side of the patient's head. The patient was asked if they could reach the call light pad and they indicated by nodding and mouthing words that they could not. The patient attempted to activate the call light pad multiple times with their mitted right hand and were not able to. The call light pad was moved by staff to a lower position on the bed near the patient's right hip. The patient then demonstrated they were able to activate the call light by tapping it with their mitted right hand.

5.b. During interview on 11/13/2024 at the time of the observation regarding Patient 22, the IDON confirmed the patient was not able to activate the call light until after it was moved.

5.c. Review of medical record documentation for Patient 22 with IDON on 11/13/2024 beginning at 1125 reflected the patient was admitted to the hospital on 10/25/2024 with diagnoses that included respiratory failure, encephalopathy, and physical deconditioning. The record further reflected the patient was "bedbound" and had aphasia with impaired ability to speak. Review of the nursing care plan revealed there was no nursing care plan that addressed the patient's call light needs, including problems, goals and individualized interventions based on an assessment of the patient's needs, including an adaptive call light device and placement of the device so that it was easily accessible.

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PATIENT RIGHTS: FREE FROM ABUSE/HARASSMENT

Tag No.: A0145

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Based on interviews, review of incident and medical record documentation for 14 of 16 patients who were reviewed for incidents (Patients 1, 2, 3, 5, 6, 7, 8, 13, 16, 18, 19, 20, 22, and 23), review of the grievance log and grievance documentation, review of internal investigation and corrective action documentation, and review of P&Ps it was determined that the hospital failed to ensure each patient's right to be free from all forms of abuse and neglect. Prevention of, identification of, investigations of, and response to, incidents that reflected potential abuse and neglect that resulted in actual and potential patient harm, were not clear, complete, and accurate to ensure those incidents and events did not recur for the hospital's medically complex and vulnerable patients. The hospital failed to identify all incidents and adverse events that required investigation, failed to conduct clear and complete investigations to identify and address all evident gaps and findings, failed to analyze those gaps and findings to determine whether potential concerns and allegations were substantiated or not, and failed to develop and implement corrective action plans based on investigation findings.

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

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

Findings include:

1.a. For Patient 1, review of the "24 Hour Supervisor Report" for 01/12/2022 day shift reflected that "Primary nurse stated patient exhibiting signs of increased confusion; [spouse] agreed. 1035 this morning, patient reportedly called the police with abuse allegations towards primary nurse. Spoke with officer, re: patient's report, pt did not want to talk to officer, officer only spoke with [spouse]. Primary nurse spoke with and reassigned. Pt's [spouse] not wearing mask/face shield/gowns/gloves, educated and verbalized understanding."

1.b. Review of the medical record for Patient 1 revealed it included the following information and notes written prior to and on the day that the abuse allegations in Finding 1.a. were reported to hospital staff:
* Patient admitted on 01/11/2022 at 2006 with primary diagnosis of "Acute Respiratory Failure with Hypoxia."
* 01/11/2022 at 1602 RN 4 wrote: "PAIN 9 BUTTOCK FIO2 35 ATC"
* 01/11/2022 at 2256 RN 4 wrote: "Patients [sic] had a few episodes of bradycardia in the 40's. [LIP] notified and placed patient on telemetry. Patient was placed on the ventilator. About an hour after admission patient became very anxious and requested to go back to ATC. Given 25 mg PO Atarax with minimal relief. [Patient] then became very anxious and started to hyperventiliate [sic] and bucking on the vent with high [peak inspiratory pressure] with RR of 50's. MD notified and given patient 2 mg IV Ativan and placed patient back on the trach mist. Hand off report given to NOC nurse."
* 01/12/2022 at 0800 RN 4 completed a Nursing Shift Assessment Flowsheet.
* 01/12/2022 at 1015 RN 4 wrote their last note in this patient's record: "This morning patient was confused an seemed to be delerious [sic]. [LIP] notified. Patient denies pain, SOB, dizziness. Tolerating being on the vent. Given report to uncoming [sic] [RN] this morning."
* 01/12/2022 at 1415 another RN wrote: "Received a report from [RN 4] at around 1145, this nurse continued to take care of this Pt. Pt is AOx4, c/o SOB, coarse auscultated in all fields and fine crackles in lower lobes. Chest x-ray, blood draw performed per order. Atrax [sic] given, effective to SOB. No ventilator mode changed yet. Notified provider. Furosemide 60mg IVP twice given today, urine output 200ml, 280ml, a large solid chux changed in the evening. [Will continue to monitor] urine output, respiratory and cardiac status."

1.c. Review of the "24 Hour Supervisor Report" for 01/23/2022 day shift reflected for Patient 1 that "PIV infiltrated, IV [potassium chloride] ordered for hypokalemia not completed due to pt wanting it run slowly over DAY; tele MD notified, spoke to pt via cell phone in the presence of NOC supervisor, STAT labs ordered & [potassium] >3, tele MD ordered 40 MEQ [potassium chloride] PO, administered to pt. Spouse asked to wear mask at all times, including in pt room per hospital policy ... Pt refusing to take diuretic due to [them] saying it is contributing to [their] hypokalemia. Provider spoke with patient and [spouse], provider is transferring care to [another physician] due to patient's concern that [they are] trying to 'kill' [the patient] with potassium replacement. [New physician] to speak with patient about plan of care going forward. I spoke with patient and [they] stated, 'there is a mistrust issue here ... one person says something, another says something else.' Then patient asked to be left alone to think about things. I informed patient and [spouse] that I am available if [they] would like to talk to me further, pt and [spouse] verbalized understanding. [Spouse] is wearing mask/face shield while staff is in the room."

1.d. Review of the medical record for Patient 1 revealed the following note about the day that the allegations of improper care in Finding 1.c. were reported to hospital staff:
* 01/24/2022 at 2204 an LPN wrote: "Late documentation for 1/23/2022 - Assumed care approx. 0730 ... [Patient] had been distraught from an evening where [they] felt [they] could not trust a potassium IV as [they] looked it up online and related it to a lethal injection. [Patient] felt a burning sensation to [their] IV site the previous day where the nurse d/c'd the line after flushing. We discussed [their] lab values and [their] potassium had been 3.2. [Patient] refused [their] torsemide as [they] also looked up this medication and was worried it would further deplete [their] potassium level. During an open ended conversation with the pt. [they] expressed [they have] a current police investagation [sic] and is waiting to file it until [they leave]. [They] said [they have] recordings of staff members. House [supervisor] was notified regarding recordings. The PA was notified of the refusal of medication. I had asked the [spouse] quietly on the side if [they have] a face shield and would please put it on. [Spouse] did have a face mask throughout the shift. [Patient] was immediatley [sic] upset. I reinforced it is a hospital policy and while in the hospital visiting it needs to be worn. I apologized for the inconsistency which is what prompted the agitation. [Spouse] agreed to wearing it. The pt brought up leaving AMA however accepted the policy. Pt. was suctioned throughout the day and encouraged to cough. [Patient] had been cleared for [their spouse] to take [them] out to the courtyard. I brought a full portable tank to [their] w/c and switched it out with [their] old tank ... oxygen was switched to the portable tank and set to 4L NC. The pt had been given a shower by the caregiver, then assumed they went out to the courtyard. After about two hours from the start of shower this nurse called the first floor and front desk inquiring on pt location. No one had seen pt and security went to look for them. Not too much time had passed and [the spouse] brought [patient] back to the room ... was given new telemetry pads and pulse ox reconnected. The oxygen tank was completely empty. [The spouse] asked if the oxygen tank was running at 8L cont if the tank could run out within a couple hours? I said yes then inquired why it was set so high. [Spouse] stated it was turned up while [patient] was excersising [sic]. I educated the affect of too much oxygen on the body. Both the pt and the wife expressed how impressed they were with [physician] ... No other concerns at this time."

1.e. There were no incident reports or incident investigation documentation provided for the allegations made on 01/12/2022 and on 01/23/2022.

1.f. During interviews with the CCO on 11/14/2024 they stated they were unable to find any incident report or investigation documentation for Patient 1, including none for the alleged alleged "abuse" reported to the hospital by a police office on 01/12/2024.

1.g. In a follow-up email from the CCO received on 11/20/2024 at 1153 they wrote "I have looked again and cannot find any information [about an incident for Patient 1]. I went through the binders in the quality office. There is zero documentation on this."

1.h. In an email from RN 4 received on 12/03/2024 at 1234 they wrote about the January 2022 allegation related to Patient 1: "To the best of my memory, this patient presented with respiratory issues and was very anxious and confused which required prn anti-anxiety medication. The following day or so when I was taking care of the patient; the patient was very anxious, confused and appeared to exhibit signs of encephalopathy possibly related to liver issues/metabolic. Shortly [sic] during my shift I was asked by the hospital supervisor to reassign this patient to another nurse because there was an allegation made by the patient that I assaulted the patient, which is false. Soon after I gave report ... I was requested to come into the CCO office ... [The former CCO] stated that they had to do an investigation and follow protocol with Quality regarding the accusation. Within about a week or two the patients [sic] encephalopathy had improved and [they] stated to [their spouse] that [they were] so sorry that [they] had a false allegation against me that I have assaulted [them]. The patient requested for me to come into the room so [they could] apologize and was quite tearful for [their] remarks. Then [the former CCO] stated that the patient stated to [them] that [they] made a false accusation regarding the assault and that the patient was confused at the time. [The former CCO] said that the proper protocol was made and quality had managed the false accusation."

1.i. In an email from the Director of Quality received on 12/03/2024 at 1207 they wrote "I went through every incident report for the entire month of January 2022 and there is nothing for this patient."

2. For Patient 2, incident documentation was reviewed and reflected:
* On 03/17/2022 at 1222 a physician "walked by patient's room and noticed patient lifted in the [Hoyer] sling with no staff members in the room. Addressed the issue with the PTA assisting the patient into his wheelchair [who stated] 'I was just going into the room down the hall to get supplies. [Patient 2] was lifted up over the bed.' Informed the staff member of the importance of never leaving patients unattended while lifted in the [Hoyer] sling and having another staff member assist with transfer, PTA verbalized understanding. Spoke with PT Director, re: this incident."
* The "Incident Action Plan" section of the form was blank.
* An "Incident FollowUp" note completed on 03/24/2022 at 1052 reflected "As per Director of Rehab ... provided real time feedback: Rehab Director provided education and counsel to the PTA to address patient safety and review facility policy that all [Hoyer] transfers are to be performed with 2 person assist and that patients are never to be left alone in [Hoyer] lift. PTA verbalized understanding and assured Director it would not occur again."
* There was no other investigation or follow-up documentation.

There was no evidence of a thorough investigation for Patient 2 to identify practice gaps and of a corrective action plan to ensure the unsafe practice that had the potential to result in serious harm would not recur for that patient or other patients in the future. It was unclear how it was possible that a Rehabilitation Department PT staff member thought it was an acceptable and safe practice to leave a patient alone and unattended while hanging above the ground from a lift. The investigation was incomplete and unclear. For example:
*Why did the "PTA" leave the patient unattended while they obtained supplies? Had they asked other Rehab or nursing staff for assistance? Were there no staff available to assist?
*What supplies was the "PTA" going down the hall to retrieve that needed to be obtained while the patient was hanging in the lift?
*What were the "PTAs" training, qualifications, and competencies?
*Were they an employee or a temporary "agency" staff person.
*How long had they worked at the hospital and had they completed a comprehensive orientation and onboarding that ensured they were competent to provide safe care?
*Were transfers, including lift transfers, included in policy training and competency processes?
*Were the policies current, clear, and complete?
*Were there other incidents or practice concerns identified for this "PTA" or had they been counseled previously?
*Had this type of incident occurred previously for that patient or other patients?

3. For Patient 3, incident documentation was reviewed and reflected:
* On 11/28/2022 the patient's family "filed a grievance as follows: 'There are multiple incidents, medication errors, negligent, and [staff] did sedate [patient] with medication ... Dried feces I have found on [the patient] ... Been over an hour to get [patient's] medication or a bowel to be cleaned up. Happens on multiple occasions. Now I am the one that changes [the patient], cleans [patient] up. [Patient] has not been bathed in about 3 weeks. I had to give [patient] a bath 2 days ago myself. I do all [patient's] care besides give [them their] medication.'"
* The "Customer Requested Follow-up" section documentation was "... will treat this as a grievance and investigate these allegations."
* The "Type of Resolution" section of the form was blank.
* The "Customer Satisfied" section was blank.
* The "Suggestions for Improvement" section was blank.
* The "Incident Action Plan" section was blank.
* An "Incident FollowUp" note completed on 12/01/2022 reflected that a pharmacist wrote "I addressed specific pharmacy concerns regarding [the patient's] medication schedule and specifically with medication that can cause sedation with the DQM." There was no evidence of an objective investigation of the number of orders for medications with sedation or drowsiness side effects, the frequency of administration of those, and the patient's response to those. Further there was no indication of investigation into the alleged "medication errors."
* "Incident FollowUp" notes also included on 12/01/2022 that "That this family member has been unhappy since the pt was admitted to [Vibra]. I and several other staff have had many conversations with the pt and the family member on care and have enacted hourly rounding, I personally checked in on [them] and the pt daily as did others to ensure care was given. The family member does assist with care and does help with turning for [they want] to take part. There have been staffing issues and staff are informed to attend to pt light [sic] ASAP and to clean. This family member been [sic] in conversations and we have worked with [them] for several weeks on options and close monitoring of the pt and [their] care ..." The investigation was incomplete, unclear, and ineffective as after 12/01/2022 there continued to be a significant failure by staff to provide bathing and incontinent care. Further, the "Incident Action Plan" section was blank as identified above and there was no formal corrective action plan documented.
* The final entry in the "Incident FollowUp" notes was "DQM investigated grievance which resulted in the drafting of a certified letter. [Patient 3's family member] is staying at Vibra hospital. Once draft is finalized I will personally deliver letter to [them]."
* There was no further documentation and there was no evidence of a letter. No letter or other incident/grievance documentation was provided as had been requested by the survey team.
* The final incident documentation entries were under the "Assessment" section and were "Incident Status: Open" and "Incident Severity: 0."

Refer to the Findings for Patient 3 under Tag A-395 that reflected the patient's personal care, hygiene, skin care, and other needs had not been met. Based on those findings it is reasonable to believe that the family member conducted personal care tasks because they were not being done by staff. Refer also to Tags A-405 and A-500 related to Patient 3's medication regimen and administration findings.

4.a. For Patient 5, incident documentation for the first of five incidents reviewed for the patient was entered on 12/24/2022 at 0627 and reflected:
* The patient was "Found seated on L side of bed, no apparent external trauma ... Endorses nausea and states [they feel] very hungry. TF running but stopped for nausea ..."
* The "Recommendations" section of the incident documentation reflected only "Fall mats."
* The "Incident Action Plan" section of the documentation was blank.
* The "Incident FollowUp" section reflected only "Proper care and evaluation of pt post fall and continued tx and assessments related to the nausea. Staff aware of fall risks and fall risk precautions provided per protocol. Pt remained in house ... RRT protocol followed. MD and family notified. No harm to patient. Fall mats added."
* The "Assessment" section for this 12/2022 incident reflected only "Incident Status: Open."

The incident documentation for Patient 5 did not constitute an investigation as to the reason or cause of the fall, it contained inaccurate information, and was unclear and incomplete and did not provide assurance that this incident would not recur. For example:
* There was no evaluation as to why the patient attempted to ambulate by self and the cause of fall. For example: Had the patient attempted to go to the bathroom to urinate? Had the patient used their call light prior to request assistance and had not been responded to? Did the patient's elevated blood sugar contribute?
* The "Incident FollowUp" contained contradictory information where it said that "fall risk precautions provided per protocol" and then said, "Fall mats added." The care plan dated 12/18/2022, six days prior to fall, included fall mats as an intervention, yet the 12/24/2022 nurse's note reflected that fall mats were not in place and were then provided to the room by security staff.
* Further, the 12/24/2022 Rapid Response note reflected staff were made aware of the fall by the patient's O2 sensor alarm. There was no indication that a bed alarm was in place, or if it was in place that it sounded when the patient got out of bed.
* It lacked evaluation about whether other 12/18/2022 care plan interventions had been in place such as non-skid socks, and assessment of toileting needs every two hours.

4.b. Documentation for the second incident for Patient 5 was entered on 01/01/2023 at 1906 and reflected:
* "O2 sat dropped to 54% about 5 min after patient was wearing PMV on while cuff was inflated [sic]. PMV removed. O2 sat recovered right away. It was 88% when RRT arrived in the room. RT deflated cuff."
* The "Recommendations" section of the incident documentation reflected "Cuff should be deflated before PMV on. Supervise patient at least 10 min after PMV on."
* The "Incident Action Plan" section of the documentation was blank.
* The "Incident FollowUp" section reflected "Educate staff on proper use and application of PMV. RT to support and assist staff on use of PMV and deflation of trach balloon ... Spoke with RT on shift at the time of incident. RT stated that [they] did not put the PMV on the patient. I went over procedure for PMV use with RT and RN ... Patient's oxygen dropped while trialing passy muir valve. Staff acted quickly and SPO2 returned to normal. No harm to patient."
* The "Assessment" section for this 01/2023 incident reflected only "Incident Status: Open."

The incident documentation did not constitute an investigation as to the reason the PMV was incorrectly placed, and it was unclear and incomplete and did not provide assurance that this incident would not recur. For example:
* There was no identification that the plan of care lacked any reference to the fact the patient was on ventilator, including a trial for PMV placement.
* There was no evaluation of the patient's medical record and plan of care to determine when the "trialing" of the PMV was planned and initiated, what a "trial" meant and how it was to be conducted, including who was responsible for placement of the device and when.
* The RT denied they had placed the PMV, yet there was no further investigation into who had done so.
* There was no evaluation of training and competency for any staff who were intended to place the PMV and to all staff responsible for any aspect of ventilator care for the patient.

4.c. Documentation for the third incident for Patient 5 was entered on 01/04/2023 at 0224 and reflected:
* "Pt was found sitting on the floor next to [their] bed. RRT called. Pt was assessed and assisted back into bed. Pt reports that [they] did not hit [their] head, Pt report no new pain. Telemed notified, chest x-ray ordered."
* The "Recommendations" section of the incident documentation was blank.
* The "Fall Prevention Interventions (Prior to Fall)" section, the "Medication(s) in the last 6 hours" section, the "Nature of Injury" section, the "Incident Action Plan" section, and the "Incident FollowUp" section of the documentation was blank.
* The "Assessment" section for this 01/2023 incident reflected only "Incident Status: Unapproved."

The incident documentation did not constitute an investigation as to the reason or cause of this second fall on 01/04/2025, including evaluation as to why the second fall occurred in the middle of the night or early morning hours similar to the patient's previous fall on 12/24/2022, and whether all interventions had been in place.

4.d. Documentation for the fourth incident for Patient 5 was entered on 01/08/2023 at 1858 and reflected:
* "Dropped O2 sat 64 then down to 20% with TM [unclear acronym]. Called RRT. Applied suction and ambu bag. Back to 98%."
* The "Recommendations" section of the incident documentation reflected only "Appiled [sic] suction and ambu bag with oxygen. Check ABG."
* The "Incident Action Plan" section of the documentation was blank.
* The "Incident FollowUp" section reflected "Proper assessment and treatment of pt in distress. Follow up documentation. No further complications at this time ... RRT protocol followed. Pt oxygen dropped into the 20s. Suction and bagging administered and pt oxygen returned to acceptable limit ... Critical low staffing with two nurses for second floor. Patient has trach with inability to manage own airway. Patient unable to clear own secretion. Sudden drop in O2 may have been related to inability to clear own secretions, mucus plug, inability to utilize call light effectively and or need for suctioning. Education to staff regarding frequent assessment of lung sounds and airway. Call light should be assessed every shift for appropriateness for use. Call light within reach of desaturation [sic]. Patient suctioned and bagged without additional low O2. No additional notes."
* The "Assessment" section for this 01/2023 incident reflected only "Incident Status: Open."

The incident documentation did not constitute a clear and complete investigation as to the reason for the patient's significant oxygen saturation drop and did not provide assurance that this incident would not recur. For example:
* Although there was a list of things that "may have" contributed to the incident, there was no investigation into the actual cause.
* There was no evaluation of the medical record, plan of care, or hospital policies and procedures, and no interviews with staff, to evaluate interventions used for weaning the patient from the ventilator. The RT note written on 01/08/2023 reflected the use of both PSV and ATC methods and it was unclear whether either one of those, or both, had contributed to the incident. Further it was unclear whether both methods were to be used and unclear what the plan for use of those was, when, and who was responsible for making that decision.
* Further, it was unclear how "critical low staffing" was thought to have contributed to the patient's drop in oxygen saturation.

4.e. Documentation for the fifth incident for Patient 5 was entered on 01/14/2023 at 1358 and reflected:
* "Patient was about to receive a bed bath ... When HOB was lowered, O2 saturations dropped to 51%. Bagging and suctioning resolved this situation, the patient remains stable at this time."
* The "Recommendations" section of the incident documentation was blank.
* The "Incident Action Plan" section of the documentation was blank.
* The "Incident FollowUp" section reflected only "Increased education and monitoring of staff in regards to pt health and status with changes in both posturing and possible changes in breathing, heart rate, [blood pressure] and LOC ... Trach and vented patients to remain HOB 30 or greater. Education provided to staff. Staff called RRT, appropriate response, patient stable with bedside care."
* The "Assessment" section for this 01/2023 incident reflected only "Incident Status: Open."

The incident documentation did not constitute a clear and complete investigation as to why the patient's HOB was lowered which caused the patient's oxygen saturation to drop. For example:
* Although the documentation reflected that "Trach and vented patients to remain HOB 30 or greater", there was no evaluation of the patient's medical record, physician's orders, or plan of care to evaluate whether HOB position was identified as an intervention for the patient. The nursing admission assessment identified "Head of Bed Elevated? Yes." Although there was a physician order for "HOB 30-45 degrees As Needed PRN ... positioning" there was no identification as to why this was "as needed" and what that meant for this patient. In addition, there was no information on the plan of care related to HOB position.

5.a. For Patient 6, incident, grievance, and medical record documentation was reviewed and reflected:
* On 04/02/2023 the "NOC House Supervisor and orientating [sic] House Supervisor were walking to Supervisor Office on 3rd floor when approached by [Patient 6] in [their] wheelchair. [They] had taken the elevator from 1st to 3rd 'to talk to the supervisor.' Patient stated [they had just received [their] shower from an aide on 1st and wanted to report that the 'shower water was way too hot and the person was too rough giving me my shower.' Asked for a description and patient described [CNA 5] assigned to [their] section. Offered to speak with staff and/or switch staff. Offered to assist patient back to 1st. Patient accepted wheelchair ride back to [their] room and stated [they were] fine for the night."
* The "Recommendations" section reflected "Spoke with CNA about incidence [sic] and reminded [them] to 'slow down' cares and notify patient of plan before giving cares. Spoke with floor nurse who also reported that patient had stated 'shower was too hot and rough.' Notified staff in shift change to go slow and notify patients of plan before cares are given so they are part of process. Double check shower temperature with patient throughout shower."
* The "Incident Action Plan" section of the form was blank.
* The "Assessment" section of the form reflected only "Incident Status" as "unapproved." It was not clear what that meant.

5.b. There was no indication that an investigation of the allegation of "rough care" and that water "was way too hot" during a shower had been conducted, nor that corrective actions to prevent recurrence had been taken to protect Patient 6 and other patients. For example: There was no indication that an interview with the patient had occurred to clarify what they meant when they said the staff person was "too rough," what they meant by the water was "too hot," whether they had expressed any complaints to CNA 5 at the time, and if so what the CNA's response was. There was no indication staff observed the patient's skin to assess for reddened or burn areas from hot water nor indication that other parts of the patient's body had been assessed for injury based on "rough care." There was no evidence that CNA 5 had been interviewed about how they conducted the shower and why the patient might feel the shower was "rough" and the water too hot. There was no indication that policies and procedures had been reviewed to determine if the CNA had followed those. There was no indication that the CNA 5 had completed all required training and competencies for bathing, showering, and patient's rights. There was no indication that building maintenance staff had been consulted to evaluate whether hot water temperatures to patient rooms on that floor exceeded the maximum safe temperatures.

5.c. A letter dated 04/05/2023 to Patient 6's family from the hospital CEO contained the following:
* A list of complaints and concerns that included "Shower temperature and improper touching and [sic] while bathing [Patient 6]."
* The letter stated that "the investigation was concluded on Wednesday, April 14th, 2023." However, the letter was dated nine days prior to the "investigation" conclusion date recorded in the letter.
* The letter stated that "Upon ... receiving the email from ... regarding [Patient 6's] bathing the following actions were taken: "Immediate interview with [Patient 6] ... visually examined [Patient 6] ... did not see any marks on [them]. Portland Police were called ... Officer interviewed [Patient 6] ... CNA in question was also interviewed ... Corrective actions were taken. Education has been provided to nursing staff regarding bathing procedures and expectations. [Patient 6] now has two caregivers at all times when care is provided."
* The contents of the letter did not include evidence or assurance that a complete and thorough investigation had occurred and that appropriate corrective actions had been taken documentation such as that described in the examples identified in Finding 5.b. above. Further, the information in the letter raised more questions such as what was "improper touching" versus "rough care," and who called Portland Police and what was the outcome of the interview.

5.d. A Nursing Patient Care Note in the medical record electronically signed by an LPN on 04/07/2023 at 2008 reflected "Received a call later in the shift from house [supervisor]. Patient is to have two staff members room at all times with any interaction for accusations made against staff. Paper sign was hung on door stating this per house [supervisor] ..."

5.e. On 04/25/2023 at 1502 a Case Manager note in the medical record reflected that a message was received that "... a police officer will be in the facility to interview pt on Thursday 4/27 @ 1300. RNCM relayed info to pts [family] to support pt." It was unclear if this was yet another police interview related to the same allegations.

5.f. Documentation of a second incident for Patient 6 reflected:
* On 05/07/2023 the "Pt unhappy that [CNA 5 who conducted the rough shower] came into the room with the RN as the second. [Patient called] their [family] to tell them that [they] did not feel safe, they then called the Portland [Police Department] to come investigate. Portland [Police] showed up to the facility, and spoke with Security, Nursing Supervisor, LPN, RN, the Patent, and the patient's [family] when they showed up. Pt told them that [they were] scared, and did not feel safe when [they] saw [CNA 5.] [Portland Police] stated that since there was n

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0164

******************************************************
Based on interview, review of medical record documentation for 2 of 2 patients for whom restraint assessment was reviewed (Patients 8 and 9), and review of hospital procedures, it was determined the hospital failed to ensure patient's rights to freedom from physical and chemical restraints. Assessments for the hospital's medically complex and vulnerable patients that justified the use of restraints prior to the initiation of restraints were not clear, complete, and comprehensive. Failures included:
* Lack of assessment of the reason, or cause for the need for restraints, including that distinguished between those used for non-violent, non-self destructive behavior and those used to manage violent or self-destructive behavior.
* Lack of assessment of the reason, or cause for the need to use multiple types of restraints simultaneously.
* Lack of assessment of the use of less-restrictive and alternative interventions prior to the initiation of restraints.
* Lack of assessment of the administration of multiple medications with sedative effects to prevent chemical restraint.

Findings include:

1.a. Review of Patient 8's medical record reflected they were admitted to the hospital on 12/01/2023 and discharged on 03/06/2024. The "History and Physical" signed by an MD on 12/01/2023 at 1942 included the following information about the patient's problems and needs: "multitrauma from 11/3/23 motorcycle accident ... [Altered Mental Status] still, but understands questions, randomly moving [their] hands which will required [sic] restraint ... Medically Complex ... ORIF right distal arm FX Date: 11/08/2023 ... alert, anxious, understands questions, mild confusion ... right forearm casted (due to ORIF for fx) ... agitation ... [Right] medical [sic] and lateral anterior max sinus wall fx, orbital floor fx, [Right] periorbital hematoma and laceration ... see plastic surgeon in 2 [weeks] ... T5 and 7 wedge [compression fracture] TLSO [thoracic lumbar sacral orthosis brace] when up - PT/OT ... ORIF thumb 1st [metacarpal] fx/dislocation - splint, WBAT [Right upper extremity] ... " The MD's notes also included the patient was "randomly moving [their] hands which will required [sic] restraint." There was no other information that described why "random moving" of the hands, including the one on the right fractured arm that was "casted" and "splinted" according to the H&P, would justify physical restraint.

1.b. The "Nursing Admission Assessment" for Patient 8 was signed by one RN on 12/01/2023 at 2032 and a second RN on 12/02/2023 at 0404. The assessment for this patient with numerous complexities and needs was largely incomplete and it was unclear what aspects of the "assessment" had been documented by each of the RNs. The minimal assessment information that had been documented included: "Unsafe behavior observed. Inconsistently follows safety recommendations and directions ... Side Rails Up x4 (If selected, must complete the Restraint Documentation) ... Inattention ... Behavior present, fluctuates ... Disorganized thinking ... Behavior present, fluctuates ... Altered Level of Consciousness ... Behavior not present ... [Confusion Assessment Method] Screen Results - Negative Screen ..." The majority of the assessment had not been completed, multiple sections were blank, and those included: "Admission Precautions/Conditions ... Social History ... Mood Interview ... Pain ... Neurological ... BIMS [Brief interview for mental status] ... Richmond Agitation Sedation Scale ... Nursing Goals/Discharge Planning ..." In the nursing assessment, other then the reference to "restraint" in relation to the four side rails for which there was no reason documented, there was no other reference to restraints. There was no description of the "unsafe behavior observed" and no other information that identified the patient's behaviors. There was no comprehensive assessment that justified the need for and use of restraints, including whether less restrictive and alternative interventions had been attempted prior to restraint use.

1.c. An Excel "Restraint forms" flowsheet for Patient 8 contained documentation that reflected the patient was in some form of physical restraints for 95 days of their 97-day hospitalization. There was no restraint documentation on the flowsheet for 01/12/2024 and 03/04/2024. However, the flowsheet did not capture clear and complete documentation of comprehensive RN assessment of the need for restraints, including whether alternative interventions had been attempted. The flowsheet specified "RN Name:" to be recorded for each entry. However, many of the entries reflected the "RN Name" was recorded by an LPN, for some entries there was no "Name" recorded, some entries were recorded with only a first name, and other entries were recorded with no title/credential.

The restraint flowsheet documentation was unclear and incomplete, and further reflected occasions when multiple types of restraints were applied on the patient at the same time. It reflected restraint use in a section for day shift that was followed by a section for night shift. It only reflected restraint use on a specific date at the specific time that the author entered the data into the flowsheet. It did not reflect the length of time spent by the patient in any of the restraints prior to that entry or during the shift. There was generally one dated/timed entry of restraint use per day identified on the list that follows, on some dates there were two entries for the day, and on two dates there were three entries for for those days:
* "Full - 4 Side Rails" were documented as in place on 12/02/2023, 12/04/2023 through 12/07/2023, 12/17/2023 through 12/19/2023, and 12/24/2023 through 12/30/2023.
* "Mitts x 2" were documented as applied on 12/01/2023 through 12/06/2023.
* "Soft Wrist x 1" were documented as applied on 12/18/2023, 12/19/2023, and 01/10/2024. Right or left was not specified.
* "Soft Wrist x 2" were documented as applied on 12/01/2023 through 12/17/2023 and 12/19/2023 through 01/10/2024. Those were also applied simultaneously with the mitts.
* "Freedom Splint x 1" was documented as applied on 12/12/2023 and 12/16/2023 through 12/18/2023, but the extremity was not specified. Those were also applied simultaneously with the wrist restraints.
* "Freedom Splint x 2" was documented as applied on 12/08/2023 through 12/12/2023, but did not specify the extremities. Those were also applied simultaneously with the wrist restraints.
* "Soft Limb x 1" was documented as applied on 12/06/2023, 12/08/2023 through 12/17/2023, and 01/09/2024. The "limb" was not specified.
* "Soft Limb x 2" was documented as applied on 12/02/2023, 12/08/2023 through 12/10/2023, 12/21/2023, and 01/04/2024 through 01/06/2024. The "limbs" were not specified.
* "Right Arm" and "Left Arm" both had unspecified restraints applied on 12/01/2023 through 01/10/2024. However, they type of restraints, on which arm, and where on the arms were not specified.
* "Right Leg" had restraints applied on 12/05/2023, 12/06/2023, 12/09/2023 through 12/16/2023, and 01/08/2024 through 01/10/2024. However, where on the leg was not specified.
* "Net Enclosure Bed" or Posey bed was documented in use on 01/10/2024, 01/11/2024, 01/13/2024 through 03/03/2024, and 03/05/2024.

1.d. Review of the interdisciplinary progress notes in the medical record reflected that as Patient 8's hospitalization progressed it became increasingly unclear whether hospital staff applied restraints for "medical reasons" or "behavioral reasons" and there was lack of any comprehensive assessment that distinguished those reasons. The lack of assessment was identified in extensive notes in the record and following are some examples. For example:
* On 12/02/2023 at 1846 an RN signed a note that reflected the use of restraints had been initiated: "Very confused, Agitated, Moving around on the bed very often. On B wrist restraints, B mitts on Sitter at all times ... Patient removes condom cath." That was the first nursing note in which restraint use was documented. There was no evidence of a comprehensive assessment that justified the use of wrist restraints on both arms, including the fractured arm, in conjunction with mitts, and that included whether alternative interventions to avoid restraint use had been attempted.
* On 12/04/2023 at 1913 an RN signed a note that reflected "Patient on restraints, Mitts, SWR's and 4 rails ... Discussed restraint options with DON, continue restraints at this time. No further reports this shift." There was no indication as to what "restraint options" had been discussed. There was no documentation to reflect a comprehensive assessment that justified the use of multiple restraints, including "4 rails." Further, the use of side rails to keep a cognitively impaired patient in bed posed a risk of additional injury and harm
* On 12/05/2023 at 0448 an RN signed a note that reflected "contacted physician in regards to pt tucking feet/legs under [their] buttock, and flipping onto [their] stomach, very disoriented, agitated. Order for one lower limb restraint to be added." There was no evidence of a comprehensive assessment to justify the addition of more restraints, including whether alternative interventions had been attempted prior to the use of lower limb restraints.
* IDT Conference notes reflected a conference was conducted on 12/06/2023. Under the "Nursing" section a checkmark was made in a box for "Restraints." However, there was no other information about the behaviors that resulted in restraint use, the extent of the type and length of restraint use, or any aspects of restraint management. Under the "Case Management" section a note reflected "... has restraint for agitation ..." It was unclear what "agitation" meant for Patient 8 and what specific behaviors required restraint use. There was no information to reflect a comprehensive assessment for the use of restraints.
* On 12/06/2023 at 1808 a COTA signed an OT note that reflected "Pt quite fidgety. Pt does not acknowledge the NWB precaution to RUE. Pt shown with edema/swelling in R hand and bandaged. Pt on bilateral restraints and R ankle restrained ... COTA blocking legs on Left side of the bed due to pt attempting to bring LLE over EOB too far increasing fall risk ... Pt began to remove bandage off of right hand. [Staff name] to look for mitts, however, hospital out of mitts. Nursing to check in on double restraints to wrist. Handed off to nursing. At this time, pt is not appropriate to continue therapy session ... Pt left restraint removed and given sock to don ..." It was not clear what "double restraints to wrist" meant, particularly when the right hand was already edematous/swollen, and it was concerning that the hospital would be "out of mitts" if those were assessed, justified, and ordered for the patient.
* On 12/08/2023 at 1342 a COTA signed an OT noted that reflected "... pt sat up once restraint removed from RUE and RLE ankle ... Pt returned to supine in bed ... [staff] donning RUE restraint. Per RN [name], orders not in system for RLE restraint, therefore, held on RLE restraint." There was no information to reflect behaviors that justified restraint use.
* On 12/10/2023 at 0618 an ADL flowsheet note reflected "pt observed all night, restful with eyes closed. R & L wrists & elbows and R ankle restraints on all night." There was lack of RN assessment to justify the use of multiple restraints when the patient was described as "restful" all night.
* On 12/13/2023 at 1853 a COTA signed an OT note that reflected "Pt agitate [sic] stating, 'I need to go to that door' staring at the window. Pt [required] re-direction to return to bed. Pt ... to sit [edge of bed] safely and return to supine. Three wrist/ankle restraints donned." The note reflected the patient was redirected and sat safely on edge of bed. There was no assessment of behaviors that justified continued use of three wrist/ankle restraints when the patient had returned to bed with re-direction.
* On 12/17/2023 at 1919 an RN signed a note that reflected "Pt remains of [sic] multiple restraints. VSS. No new issues or concerns noted at this time." There was no assessment to justify the use of "multiple restraints" in the absence of documented behaviors. Physician's orders reflected that at that time there were orders for soft wrist restraints on both wrists, a "Soft Limb x1" to one unspecified "limb," and a "Freedom Splint x1" to one unspecified limb. However, the RN documentation did not specify what restraints on what limbs were in use.
* On 12/19/2023 at 0613 an LPN signed a note that reflected "Pt remains of [sic] multiple restraints. was able to go without bilateral wrist restrains [sic] with redirecting and medication." It was not clear why the patient was in restraints at all if alternative interventions has been effective. Further, it was not clear if other of the "multiple restraints" were in use during the time the patient was "without" the wrist restraints. There was no comprehensive assessment that considered those factors in relation to whether continued restraint use was justified, and that also included evaluation of whether the "medication" administered was used as a chemical restraint in lieu of physical restraint.
* On 12/23/2023 at 1024 an MD signed a note that reflected "... no agitation, on 3 points [sic] restraints ..." It was not clear why the patient was on "3 point restraints" when there was an absence of behaviors.
* On 01/03/2024 at 1847 an RN signed a note that reflected "Pt. alert and oriented x1 ... Intermittent episodes of trying to get OOB and pulling at tubing, continues to be difficult to redirect. PRN Diazepam given x 1 for agitation. And diluadidi [sic] x2 for pain. Speech is slurred but can answer simple yes or no questions ... Can become aggressive, attempted to hit the sitter, and used foul language." The Excel restraint flowsheet reflected that patient was in bilateral wrist restraints on that date. There was no evidence of a comprehensive assessment that included whether less restrictive interventions other than "redirect" were attempted in response to the behaviors that included violent behaviors towards others.
* On 01/06/2024 at 0712 an unknown author note on the "Patient Rounding and ADLs" flowsheet note reflected "[Patient] got out of the restraints on [their] left wrist so I tightened them both." It was not clear what "tightened" meant on both wrists, particularly in consideration of the patient's fractured right arm.
* On 01/06/2024 at 1905 an RN note reflected "Pt. drowsy this shift, calm and cooperative, continues with one-to-one sitter. Occasional episodes of pulling at PEG tube, abd binder in place." There was no evidence of a comprehensive assessment that justified the continued use of restraints when an alternative intervention, the abdominal binder, was in place.
* On 01/07/2024 at 0712 an RN note reflected "Alert, confused. Pt rested in bed with a sitter in room and bil wrist restraints as pt not able to follow direction. PEG covered and secured with abd binder." It was unclear why the patient was in restraints in the absence of behaviors.
* On 01/07/2024 at 2001 an RN note reflected "Restraints in place and checked frequently. Sitter at bedside 24/7." It was unclear what behaviors were present that justified the use of restraints.
* On 01/08/2024 at 0746 and LPN note reflected "VSS. Patient NPO after midnight. 0600 meds held due to NPO. Labs drawn. Restraints in place, sitter in room. No acute changes." Again, it was unclear what behaviors were present that justified the use of restraints.
* On 01/26/2024 at 1912 an LPN signed a note that reflected "Pt trying to open posey bed most of the time. Cooperative with all cares. Continue with net enclosed bed restraints." There was no assessment to reflect why the restraint was used when the patient was "cooperative with all cares."
* On 01/27/2024 at 0604 an LPN note reflected "patient is Alert, Oriented x 0. pt. V/s is WNR. doesn't respond appropriate answer for simple questions, confused, yelling at times, takes off all covers and briefs. pt. has posy [sic] bed , and secured well due to high fall risk and confusion. Incontinent and tends to play with [their] own BM. No [signs or symptoms] of pain or distress noted. Patient rested about 3-4hrs tonight and cover with sheet and blankets. tolerates meds crushed with apple sauce." Confusion, yelling, and taking off covers and briefs are not behaviors that justify the use of restraints and there was no evidence of restraint assessment. Further, there was no assessment or care plan that reflected the restraints were used because of the patient's fall risk, including whether alternative interventions to prevent patient falls had been attempted such as a bed alarm, a floor mattress, or fall mats on the sides of the bed.
* 01/27/2024 at 1821 "Continue with net enclosed restraints. Still trying to open his posey bed. No other concerns noted on this shift." There was no assessment to reflect why the restraint was used in the absence of behaviors. It was unclear if the behavior the patient was being restrained for was that they were "trying to open" the net enclosure bed. There was no assessment related to any other behaviors that justified the use of restraints.
* On 02/01/2024 at 1425 a PT signed a note that reflected "patient received sitting on edge of posey bed with [family members] present ... RN [name] cleared patient to sit on edge of bed with 2 [family members] present; instructed [them] that patient should not be left alone at edge of bed; they need to remain close to [patient] and guide [patient] back to sitting if [they attempt] to stand up. they state they have been here since 11am and had patient sitting on edge without issue. Instructed in how to close posey bed properly and that they need to do this when they leave." There was no assessment to reflect why the restraint needed to be used in the absence of behaviors. Further, it was unclear whether the PT provided this instruction or had documented that the RN had provided the instruction. In either event, it was inappropriate for staff to assign restraint use and management to non-staff persons and created a potential for harm.
* On 02/07/2024 IDT Conference notes reflected "Still in Posey bed with potential violent behaviors (hx choking a RN)." There was no nursing involvement or participation at that IDT Conference, the "Nursing" section of the conference form was not completed, nor was there documentation of any RN assessment or IDT evaluation of the patient's behaviors and review of interventions being used and interventions to be attempted. Although the hospital's website reflected it provided "Psychological and social support services" the "Social Services" section of the form was not completed. The only related reference was under the "Case Management" section and was "[appointment] for psych eval at hospital." There was no evidence of a comprehensive assessment related to the patient's continued restraint in the "Net Enclosure Bed."
* On 02/07/2024 at 1749 an LPN signed a note that reflected "Pt began kicking net and attempting to unzip the front of the bed." There was no assessment to reflect why the patient was attempting to unzip the bed and whether an attempt was made to determine if continued use of the restraint bed was necessary.

1.e. The Excel "Restraint forms" flowsheet reflected a lack of comprehensive assessment for restraint use. For example:
* Regarding the "Precipitating/Continued Reason for restraints" the flowsheet for Patient 8 listed three pre-printed "reasons." Those were: "... Pulling at tubing/dressing ... Unable to follow safety instructions ... Prevent disruption of life sustaining interventions (e.g., mechanically ventilated)." There was no prompt or language that required patient-specific information. There were no "reasons" listed related to patient violent behaviors that posed a risk to themselves or to others. The documentation on the flowsheet did not contain patient-specific assessment information. For example:
- On 12/02/2023 through 12/04/2023, 12/06/2023, 12/08/2023 through 12/24/2023, and 12/27/2023 through 01/09/2024, two or three of the "Reason for restraints" listed above were checkmarked as applicable. However, there was no patient-specific information related to what tubings/dressings the patient was pulling on, what "safety instructions" the patient wasn't following, and what life sustaining interventions were disrupted as the patient was not on a ventilator and it wasn't clear what the difference was between "Pulling at tubing/dressing" and "Prevent disruption of life sustaining interventions."
- For "Precipitating/Continued Reason for restraints: Other" there were no entries recorded on the flowsheet. However, the documentation throughout the hospital stay reflected numerous occasions on which it was recorded that the patient was restrained for other behaviors that posed a risk to the patient or to others, and not for any of the three "reasons" listed on the florsheet.

* Regarding "Less restrictive intervention used/considered that are ineffective" the flowsheet listed several pre-printed choices. Those were: "Pain relief/comfort measures ... Visual Supervision ... Environmental modifications ... Limit setting ... Re-orientation, verbal reminders ... Medication/Sedation ..." There was no prompt or language that required patient-specific information. Where one of more of the interventions were checked on the flowsheet, it was not clear how and when each of them had been attempted or considered ineffective at the time of that entry, and entries about other aspects were also unclear. For example:
- On 12/08/2023 at 0730 the flowsheet reflected that restraints for Soft Wrist x2, Freedom Splint x 2, Soft Limb x1 for an unspecified limb, and Soft Limb x 2 restraints for an unspecified limb were all applied on the Right Arm and Left Arm which indicated multiple restraints on each arm at the same time. In regard to those restraints the RN checked the following pre-printed flowsheet choices for Day Shift:
-- For "Precipitating/Continued Reason for restraints: Pulling at tubing/dressing ... Unable to follow safety instructions ... Prevent disruption of life sustaining interventions (e.g., mechanically ventilated)" were all checked.
-- For "Less restrictive intervention used/considered that are ineffective: Pain relief/comfort measures ... Visual Supervision ... Environmental modifications ... Limit setting ... Re-orientation, verbal reminders ... Medication/Sedation ..." were all checked. However, there was no patient-specific information related to those interventions and it was not clear how and when each of those had been attempted or considered ineffective at the time of the entry on the flowsheet.
-- For "Treatment: Wrap/hide IV sites ... Limit access to tubes and drains ... Alter placement/cover lines/tubes ... Tuck gown in pant bottoms to hide tubes" were all checked. It wasn't clear how all of those applied.
-- For "Diversional: Repetitive activities ... Music, television ... Give items to hold ... Encourage family involvement/diversion" were all checked. However, there was no patient-specific information about whether those were alternative interventions and what worked and what didn't.
-- For "Comfort: Provide familiar items from home ... Reduce stimuli/intrusions; promote rest" were checked. There was no patient-specific information about whether those were alternative interventions and what worked and what didn't.
-- For "Other:" there was no documentation.
- Further, there were no physician's orders at that time for the Soft Limb x1 for an unspecified limb and Soft Limb x 2 for unspecified limb restraints. There was not a comprehensive assessment to justify the restraints for Patient 8.

* Flowsheet entries from 12/13/2023 at 1130 through 12/16/2023 at 0510 reflected restraints for Soft Wrist x 2, Freedom Splint x1 for an unspecified limb, and Soft Limb x1 for an unspecified limb were applied to the patient's Right Arm, Left Arm, and Right Leg. However, the physician's order for a Freedom Splint had been discontinued on 12/11/2023 at 1200 and the order for a Right Ankle restraint had been discontinued on 12/11/2023 at 1200. In regard to those restraints the RNs, LPN, and an individual who only recorded their first name with no title/credential, checkmarked similar choices for "Reasons ... Less Restrictive intervention ... Treatment ... Diversional ... Comfort" as in the 12/08/2023 example above. There was not a comprehensive assessment to justify those multiple restraints.

* On 01/09/2024 at 0725 the flowsheet reflected that Soft Wrist x 1, Soft Wrist x2, and unspecified Soft Limb x1 restraints were all applied on the patients' Right Arm, Left Arm, and Right Leg. There were no physician's orders for wrist restraints or unspecified "leg" restraint until 01/09/2024 at 1319. In regard to those restraints the RN and LPN checkmarked similar choices for "Reasons ... Less Restrictive intervention ... Treatment ... Diversional ... Comfort" as in the 12/08/2023 and 12/13/2023 examples above. There was not a comprehensive assessment to justify the use of those restraints.

* Regarding the use of "Full - 4 Side Rails" as a restraint to keep the patient in bed, there were no physician's orders for those, nor did the flowsheet contain a comprehensive assessment for their use, to include attempts at less restrictive, alternative interventions to side rails.

1.f. Another format for restraint documentation, a form titled "Restraint Order and Flow Record," was provided for 14 shifts on seven days of the patient's hospital stay, between 01/08/2024 and 03/03/2024. Similar to the Excel "Restraint forms" flowsheet, documentation of restraint assessment on those 14 shifts was not clear, complete, or comprehensive. Some examples follow in Finding 1.g. below.

The "Restraint Order and Flow Record - Medical" was an electronic four-page form that consisted of two-pages for "Day Shift" followed by two-pages for "Night Shift." A paragraph at the beginning of the day shift and night shift sections reflected "Patient is assessed for medical conditions that may lead to behavior changes: Temperature elevations; Hypoglycemia; Drug interactions/side effects, Hypoxia, Electrolyte imbalances, Effectiveness of pain management. Basic Interventions For Patient in Restraints: Verbal Reminders, Exercise/Ambulation/Repositioning, Patient allowed to make choice, Reorientation, Consider relocation of patient. Sensory Aids (Glasses, Hearing Aids). *RN name below indicates basic interventions implemented.* RN responsible for patient documents behavior that necessitates restraints, patient specific interventions used (Check all that apply), and continued plan of care." The record required "RN's initials indicate that the required assessment was completed and care provided per Policy ..." and it specified "RN Initials" and "RN Name" for authentication of all entries recorded.

The "Restraint Order and Flow Record - Medical" included the following sections that contained pre-printed, generic choices to be checkmarked as applicable:
* Under Section 1 for "Less restrictive intervention used/considered that are ineffective:" were seven pre-printed options with a checkbox for each. Those were "Pain relief/comfort measures" and "Environmental modi cations [sic]" and "Re-orientation, verbal reminders" and "Diversional activities, re-focus attention" and "Visual supervision" and "Limit setting" and "Medication/Sedation." There was also a space for "Other."
* Under Section 2 for "Precipitating/Continued Reason for restraints:" were three options with a checkbox for each. Those were "Pulling at tubing/dressing" and "Unable to follow safety instructions" and "Prevent disruption of life sustaining interventions (e.g., mechanically ventilated)." There was also a space for "Other."
* Under Section 3 for "Patient Specific Interventions ... Treatment:" were five options with a checkbox for each. Those were "Wrap/hide IV sites" and "Limit access to tubes and drains" and "Alter placement/cover lines/tubes" and "IV pole/pump/tubes out of visual field" and "Tuck gown in pant bottoms to hide tubes." There was also a space for "Other."
* Under Section 4 for "Patient Specific Interventions ... Diversional:" were five options with a checkbox for each. Those were "Include in activities (e.g., ADLs)" and "Repetitive activities" and "Music, television" and "Give items to hold" and "Encourage family involvement/diversion." There was also a space for "Other."
* Under Section 5 for "Patient Specific Interventions ... Comfort:" were three options with a checkbox for each. Those were "Provide familiar items from home" and "Reduce stimuli/intrusions; promote rest" and "Position patient for comfort." There was also a space for "Other."
* Under "Other Interventions:" was a blank space for a narrative.
* Under "Plan of Care:" were two options with a checkbox for each. Those were "Restraints Continued" and "Restraints Discontinued." There was also a space for "Other."

1.g. Examples of lack of comprehensive assessment for restraint use on the "Restraint Order and Flow Record" include:
* On 01/08/2024 the "Restraint Order and Flow Record" for "Day Shift" reflected the type of restraint was "Soft Wrist Restraint x 2." However, the order for "Soft Wrist Restraint x 2" ended on 01/08/2024 at 1000 and was not ordered again until 01/09/2024 at 1318. The record was electronically signed by the RN on 01/08/2024 at 1944. Under the five "assessment" sections identified under Finding 1.f. above, 23 of the 23 options were checked. There were no narrative entries under any of the "Other" spaces or under the "Other Interventions." Under the "Plan of Care" section the option for "Restraints Continued" was checked and no other information was recorded. There was no patient-specific information related to any of the options and it was unclear whether all 23 options were applicable to Patient 8 at that time.
* On 01/08/2024 at 1951 the same RN who completed the "Day Shift" restraint record above signed a nursing note that reflected " Assumed care at 07:30. VSS. Pt NPO majority of day for PEG removal. In afternoon pt was able to remove restraint and hit the sitter x 2. Pt confused and possibly upset about being NPO. Supervisor and other nurse and CNA were able to calm pt. At dinner pts mood was improved and pt was very talkative. Pt took meds crushed in yogurt w/o issue ..." The note indicated the patient hit the sitter when the restraint was removed. This incident was not recorded on the "Restraint Order and Flow Record" and there was no RN assessment that included evaluation of what may have triggered or precipitated the hitting incident. There was no RN assessment that differentiated the use of the restraints as "medical" versus "behavioral." Further, it was unclear why restraint use continued as reflected on the restraint record when the patient was without behaviors after they were "calmed."
* On 01/08/2024 the "Restraint Order and Flow Record" for "Night Shift" reflected the type of restraint was identified as "Soft Wrist Restraint x 1" and "Soft Wrist Restraint x 2." However, the "Placement" was recorded as "Right Arm" and "Left Arm" and "Right Leg." It was not clear where on the "leg" the patient was restrained. Physician's orders for bilateral wrist restraints were not effective until 01/09/2024 at 1319, an order for an unspecified "limb x 1" restraint was not effective until 01/09/2024 at 1319, and the "right ankle" restraint was discontinued on 12/11/2023 at 1200. In addition, the "RN Initials" and the "RN Name" for authentication of the completion of the form by the RN, were completed and authenticated by an LPN who electronically signed the record on 01/09/2024 at 0619. Under the five "assessment" sections identified under Finding 1.f. above, 23 of the 23 options were checked. There were no narrative entries under any of the "Other" spaces or under the "Other Interventions." Under the "Plan of Care" section the option for "Restraints Continued" was checked and no other information was recorded. There was no patient-specific information related to any of the options and it was unclear whether all 23 options were applicable to Patient 8 at that time.
* On 01/09/2024 at 0707 the same LPN who completed the 01/08/2024 "Night Shift" restraint record above, documented "Patient calm w/ cares. Tolerated meds w/ yogurt and ice cream. Re

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0166

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Based on observation, interview, medical record documentation reviewed for 4 of 4 patients restrained with multiple types of physical restraints that included four raised bed side rails, who were reviewed for restraint plans of care (Patients 8, 9, 15, and 22), and review of P&Ps it was determined the hospital failed to protect and promote patient's rights to freedom from restraint. Clear and complete plans of care for the safe use of restraints based on patient assessment that distinguished between restraints used for non-violent, non-self destructive behavior and those used to manage violent or self-destructive behavior, had not been developed or implemented for the hospital's medically complex and vulnerable patients.

Findings include:

1.a. Review of Patient 8's medical record reflected the use of multiple restraints that included soft wrist restraints, mitts used in conjunction with the wrist restraints, ankle restraints, unspecified limb restraints, elbow restraints, Freedom Splint restraints, and net enclosure bed restraint. The first orders for restraints were written on 12/01/2023 and the patient was in restraints throughout the hospital stay until the date of discharge on 03/06/2024. The record also reflected that the patient's right forearm was casted/splinted with exposed surgical wires/pins on admission as result of fractures and surgical repair prior to admission. Refer to Tag A-164 for the findings related to comprehensive assessment for restraint use for Patient 9.

1.b. Patient 8's "Plan of Care Complete Plan" related to the use of restraints was not clear and complete, not patient-specific, and had not been updated throughout the patient's stay. Care plan "Problem 5" was dated 12/02/2023 and was for "Potential for injury related to restraints related to soft restraints and mitts to bilateral upper extremities as evidenced by potential disruption of life-saving intervention." The "Goal" was "Free of Injury." The only intervention was "1. Teach patient/family about need for restraints and care that will be provided." That was the extent of the restraint care plan.

1.c. Although as indicated in the findings in this report, throughout the patient's entire hospital stay the patient experienced physical restraints on multiple limbs, including with added risk to their fractured right arm, and eventually full restraint in a net enclosure bed, the plan of care was never completed or updated after 12/02/2023, day two of the patient's hospital stay. The care plan did not address the specific behaviors the patient exhibited that justified the restraints used; It did not identify patient-specific alternate interventions to be attempted prior to the application of restraints; and it did not identify restraint monitoring, assessment, and release interventions. Further, although the patient was restrained using hand mitts and bilateral wrists/hands/elbow restraints, leg/ankle restraints, a "net enclosure bed," and there were orders for unspecified limbs and "Freedom Splints," the plan of care referenced broadly only restraint use for "upper extremities." The application of physical restraints had potential for further injury to the patient, particularly for the patient's fractured and surgically repaired right arm that was casted or splinted, had exposed surgical wires/pins, and was NWB. Those aspects of restraint use were not addressed in the care plan to ensure safe and appropriate care that promoted healing and prevented further injury to the arm. Restraints for Patient 8 also included four raised bed side rails that created additional risk of injury and harm to those patients with cognitive impairment who attempted to exit the bed on their own and those were also not included in the plan of care.

1.d. During interview with the CMD at the time of the record review on 11/14/2024 beginning at ~ 1145 they stated that Patient 8 exhibited "violent, resistive, combative" behaviors during the hospitalization and multiple types of restraints were used to manage the behaviors.

1.e. Refer to Tags A-164, A168, A-171, A-175, A-395, and A-396 for Patient 8 related to the assessment and use of restraints.

2.a. Review of Patient 9's medical record reflected the use of mitt and soft wrist restraints. The first order for restraints was written on 01/24/2024 and the patient was in restraints throughout the hospital stay until the date of discharge on 01/31/2024. Refer to Tag A-164 for the findings related to lack of comprehensive assessment for restraint use for Patient 9.

2.b. Patient 9's "Plan of Care Complete Plan" was not clear and complete, not patient-specific, and had not been updated throughout the patient's stay. Care plan "Problem 5" was dated 01/28/2024 and was for "Potential for injury related to restraints related to soft restraints X 2 to BUE for pt. safety as evidenced by potential disruption of medical treatment." The "Goal" was "Free of Injury." The one "Intervention" was "Teach patient/family about need for restraints and care that will be provided." That was the extent of the restraint care plan.

2.c. The care plan was not complete as it did not reflect the patient-specific behaviors that required the use of physical restraints. The hand mitts used in addition to the upper extremity soft restraints were not addressed. The "Goal" was unclear as to "free" from what type of injury. The "Goals" were also incomplete as there was no indication that the desired outcome would be the patient was free from restraint. The "Intervention" was unclear related to teaching that "care will be provided." Further, there were no interventions related to any of the aspects of management of a patient in restraints, including use of alternative interventions prior to restraint application, monitoring, release, provision of specific care, etc. Further, there was no reference to the use of an "abdominal binder" (wide compression belt that encircles the abdomen) attempted by staff to give the patient "a break from [wrist restraints]."

2.d. Refer to Tags A-164, A-395, and A-396 for Patient 9 related to the assessment and use of restraints.

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3. The P&P titled, "Restraint Use" with a revise date of "6/24" and a review date of "12/23" was reviewed and reflected:
* "Policy: Restraints are ordered ... by trained personnel in response to emergent, dangerous situations as an adjunct to planned care."
* "A care plan to reduce restraint use will be implemented on all patients in restraints."
* "Raised side rails - If a patient's status requires that all bedrails be raised (restraint) while the patient is in bed, a standing or PRN order is permitted. It is not necessary to obtain a new order each time the patient is returned to bed after being out of bed."
* "Documentation is required when restraints are initiated, and throughout the episode of restraint use and will initiate or update the Nursing Care Plan: Risk for Injury."
* "Nursing Care Plan Goal for use of all restraints is to reduce and/or eliminate the use of restraint(s)."
* "Staff members shall demonstrate competence in ... developing a written care plan for patients in restraints."

4.a. During a tour of the high-acuity medical unit on 11/13/2024, at 1353, Patient 15 was observed moving and crying out while lying in their bed and all four bed railings were raised. The patient's call light was observed hanging out of reach of the patient to the right and above their head on a vital signs machine. A strong odor of feces was apparent upon entering the room. The RTM located the patient's RN and apprised them of the patient needing personal care at approximately 1354. At 1413, another RN passed by Patient 15's room and entered Patient 15's room. That RN called for assistance and personal care was provided for Patient 15 after approximately 20 minutes. Patient 15's RN was not observed responding to the RTM's request to assist Patient 15. This was verified by the RTM at the time of the observation.

4.b. Patient 15's "Plan of Care" with an initial entry of "9/11/2024" was reviewed at the time of the observation and reflected:
* There were eight dated entries beginning on 09/11/2024 through 11/12/2024.
* There were no entries for restraint use or "Risk for Injury" in accordance with the P&P.
* There was no update to the Plan of Care after "11/12/2024", the day before soft wrist and mitt restraints were ordered.

4.c. During interview at the time of the observation with the RTM they confirmed that there were no physician's orders for four bed side rails for Patient 15.

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5. Refer to Tag A-395 for details regarding Patient 22's lack of restraint care plan.

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PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0168

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Based on observation, interview, review of medical record documentation for 2 of 2 patients who were reviewed for restraint orders (Patients 8 and 15), and review of P&Ps it was determined the hospital failed to ensure each patient's right to freedom from restraints. Physician's orders for multiple types of physical restraints were not clear and complete to describe the patient-specific reasons for restraints including to distinguish between those used for non-violent, non-self destructive behavior versus those used for violent or self-destructive behavior. Restraint orders were not followed as written and physical restraints were applied without physician's orders.

Findings include:

1.a. Review of physician orders and progress notes for Patient 8 reflected physician's orders for multiple restraints were not clear, complete, or followed. For example:

1.b. Physician's orders for bilateral soft wrist restraint use for Patient 8 reflected:
* An order written on 12/02/2023 to start at 1646 and end on 12/03/2023 at 1600 was: "Continue Restraint(s) Every Two Hours, Request Type: Stat, Restraint Type: Soft Wrist Restraint x 2, Restraint Indication: Prevent disruption of life sustaining intervention." The order was written for "Duration 1 Day," as were all restraint orders in the patient's record. That order was in place for ~ 24 hours periods on 12/03/2023, 12/07/2023 to 12/10/2023, 01/06/2024, and 01/07/2024. It was not clear what specific behaviors justified the use of wrist restraints on those dates. Further, it was unclear what was meant by "Continue Restraint(s) Every Two Hours" when the order was written for 24 hours.
* An order written on 12/04/2023 to start at 1559 and end on 12/05/2023 at 1400 was: "Continue Restraint(s) Every Two Hours, Request Type: Stat, Restraint Type: Soft Wrist Restraint x 2, Restraint Indication: Pulling at tubing/dressing." That order was in place for ~ 24 hours periods on 12/05/2023, 12/06/2023, 12/11/2023 to 12/17/2023, 12/21/2023 to 12/31/2023, and 01/01/2024 to 01/05/2024.
* An order written on 01/09/2024 to start at 1319 and end on 01/10/2024 at 1200 was: "Continue Restraint(s) Every Two Hours, Request Type: Stat, Restraint Type: Soft Wrist Restraint x 2, Restraint Indication: Unable to follow safety instructions." It was not clear what specific behaviors justified the use of restraints.

Bilateral wrist restraints were used without physician's orders. For example:
* On 12/18/2023 at 1825 an LPN signed a note that reflected "continues on bilateral wrist restraints." However, the order for those ended on 12/18/2023 at 0800. Although there was an order for an unspecified "Soft Limb x 1" restraint that was effective on 12/18/2023 at 1744, it was incomplete and it was not for two wrist restraints.
* On 12/19/2023 at 0613 an LPN signed a note that reflected "Pt remains of [sic] multiple restraints." There were no orders for wrist or multiple restraints at that time. The only restraint order at that time was incomplete and was for an unspecified "Soft Limb x 1" that was effective on 12/18/2023 at 1744.
* On 12/20/2023 at 0639 an RN signed a note that reflected "been in soft wrists [sic] restraints, tried to take off restraints few times ..." There were no orders for wrist restraints at that time. The only orders were incomplete and were for an unspecified "Soft Limb x 1" that was effective on 12/19/2023 at 1150 and an unspecified "Soft Limb x 2" that was effective 12/19/2023 at 2022.
* On 12/21/2023 at 0957 a PTA signed a note that reflected "Pt's R hand appeared particularly swollen with wound on wrist in are [sic] of break. Notified RN of pt's [Non-weight bearing] status of RUE as restraints may be affecting healing." There were no orders for wrist restraints at that time. The only order was incomplete and was for unspecified "Soft Limb x 2" that was effective 12/20/2023 at 1655.
* On 01/08/2024 at 1951 an RN signed a note that reflected "pt was able to remove restraint ..." There were no restraint orders in place at that time. The order for "Soft Wrist Restraint x 2" ended on 01/08/2024 at 1000.
* On 01/09/2024 at 0707 an LPN signed a note that reflected "Restraints in place." There were no orders for any restraints on 01/09/2024 until 1319.
* On 01/10/2024 at 1341 a COTA signed a note that reflected "Pt calm and 3-point restraints removed ... restraints donned." There were no orders for any restraints at that time. Previous orders for unspecified "Soft Limb x 1" and "Soft Wrist x 2" were both discontinued on 01/10/2024 at 1000.

1.c. Physician's orders for use of hand mitts for Patient 8 reflected that they were ordered to be used in conjunction with wrist restraints:
* An order on 12/02/2023 to start at 1647 and end on 12/03/2024 at 1600 was: "Continue Restraint(s) Every Two Hours, Request Type: Stat, Restraint Type: Mitts x 2, Restraint Indication: Prevent disruption of life sustaining intervention."
* An order on 12/04/2023 to start at 1559 and end on 12/05/2023 at 1400 was: "Continue Restraint(s) Every Two Hours, Request Type: Stat, Restraint Type: Mitts x 2, Restraint Indication: Pulling at tubing/dressing." That order was repeated for ~ 24 hours periods beginning on 12/05/2023 at 1518 and ending on 12/08/2023 at 0439.

Mitts were used without physician's orders and were used in conjunction with wrist restraints. For example:
* On 12/06/2023 at 1808 a COTA signed an OT note that reflected "[Staff name] to look for mitts, however, hospital out of mitts." It was concerning that the hospital would be "out of mitts" if those were assessed, justified, and ordered for the patient.
* On 12/08/2023 at 1342 a COTA signed an OT note that reflected "Precautions: ... bil restraints and mitts."
* On 12/09/2023 at 1355 a PT signed a note that reflected "Precautions: ... in 3 point restraints and mitt." There were no orders for "mitts" at that time.
* On 12/12/2023 at 1540 a PTA signed a note that reflected "Precautions: ... in 3 point restraints and mitts ... [treatment provided] ... Pt donned in restraints and left in care of sitter." However, there were no orders for "mitts" at that time.
* PT and OT notes on the following dates and times reflected the use of "mitts." There were no physician's orders for "mitts" at those times:
- 12/11/2023 at 1041 by a COTA
- 12/13/2023 at 1853 by a COTA
- 12/14/2023 at 1147 by a PTA
- 12/18/2023 at 1328 by an OT
- 12/18/2023 at 1333 by an OT
- 12/20/2023 at 1438 by a COTA
- 12/20/2023 at 1736 by a COTA
- 12/27/2023 at 1350 by a COTA
- 01/01/2024 at 1644 by a COTA
- 01/04/2024 at 1413 by a COTA
- 01/10/2024 at 1341 by a COTA

1.d. Physician's orders for soft right ankle restraint use for Patient 8 reflected:
* An order on 12/07/2023 to start at 2000 and end on 12/08/2023 at 1448 was: "Continue Restraint(s) Every Two Hours, Request Type: Stat, Restraint Type: Soft Limb x 1, Restraint Indication: Prevent disruption of life sustaining intervention, Comments: R ankle." That order for a right ankle restraint was repeated for ~ 24 hours periods beginning on 12/08/2023 at 1448 and ending on 12/11/2023 at 1200. It was not clear what was meant by "disruption of life sustaining interventions" in relation to the patient's ankle.

Soft right ankle restraints were used without physician's orders. For example:
* On 12/05/2023 at 1048 a PT signed a "Pt Initial Evaluation" that reflected " ... in 3 point restraints and mitts ... returning restraints for safety." However, there were no physician's orders for a third extremity to be restrained at that time.
* On 12/06/2023 at 1808 a COTA signed an OT note that reflected "Pt on bilateral restraints and R ankle restrained." There were no orders for ankle restraint at that time.
* On 12/12/2023 at 0613 an RN signed a note that reflected "remains 3point [sic] restraints ..." There were no orders for a third extremity ankle restraint at that time.
* MD, Nursing, PT, and OT notes on the following dates and times reflected the use of "right ankle" or "3 point" restraints. There were no physician's orders for right ankle or a third extremity at those times:
- 12/11/2023 at 1041 by a COTA
- 12/12/2023 at 1318 by an LPN
- 12/12/2023 at 1540 by a PTA
- 12/13/2023 at 1853 by a COTA
- 12/14/2023 at 1147 by a PTA
- 12/13/2023 in Interdisciplinary Team Conference notes
- 12/17/2023 at 1342 by an MD
- 12/23/2023 at 1024 by an MD
- 01/10/2024 at 1341 by a COTA

1.e. Physician's orders for "Freedom Splints" use for Patient 8 reflected (Freedom Adjustable Elbow/Knee Splints are multipurpose soft splints that help restrict elbow and knee movement or can be used to help prevent joint contractures):
* An order written on 12/07/2023 to start at 2000 and to end on 12/08/2023 at 1800 was: "Initiate Restraint(s) Every Two Hours, Request Type: Stat, Restraint Type: Freedom Splint x 2, Restraint Indication: Prevent disruption of life sustaining intervention, Comments: Once restraint(s) have been initiated, nursing to obtain and place new order "Continue Restraint(s)" by next calendar day. Provider may also enter this order directly." There was no indication for what extremities the restraints were to be applied.
* An order written on 12/09/2023 to start at 2000 and end on 12/10/2023 at 1400 was: "Continue Restraint(s) Every Two Hours, Request Type: Routine, Restraint Type: Freedom Splint x 2, Restraint Indication: Pulling at tubing/dressing, Comments: Freedom splints on both upper extremities, ensure adequate blood flow to bilateral upper extremities." That same order was continued on 12/10/2023 to start at 1400 and end on 12/11/2023 at 1200.
* An order written on 12/17/2023 to start at 0835 and end on 12/18/2023 at 0800 was: "Continue Restraint(s) Every Two Hours, Request Type: Stat, Restraint Type: Freedom Split x 1, Restraint Indication: Pulling at tubing/dressing." There was no indication for what one extremity the restraint was to be applied to.

The use of "Freedom Splints" was not clear. For example:
* On 12/09/2023 at 0607 a "Patient Rounding and ADL" note reflected "R & L wrists & elbows and R leg restraints all on." The reference to the "elbows" may have been indicative of "Freedom Splint" application. However, there was no physician's order for those on 12/09/2023 at 0607.
* On 12/10/2023 at 0618 a "Patient Rounding and ADL" note reflected "pt observed all night, restful with eyes closed. R & L wrists & elbows and R ankle restraints on all night." The reference to the "elbows" may have been indicative of "Freedom Splint" application.

1.f. Physician's orders for the use of other restraints for Patient 8 were incomplete and unclear and could not be followed. The orders did not include what limb(s)/extremity(ies) and whether right, left, or both, were to be restrained and what specific behaviors the restraints were to be used for. For example:
* An order written on 12/01/2023 to start at 1840 and end on 12/02/2023 at 1800 was: "Initiate Restraint(s) Every Two Hours, Request Type: Stat, Restraint Type: Soft Limb x 2, Restraint Indication: Prevent disruption of life sustaining intervention ..."
* An order written on 12/05/2023 to start at 0449 and end on 12/06/2023 at 0400 was: "Initiate Restraint(s) Every Two Hours, Request Type: Stat, Restraint Type: Soft Limb x 1, Restraint Indication: Unable to follow safety instructions, Comments: Lower Extremity."
* An order written on 12/11/2023 to start at 1451 and end on 12/12/2023 at 1400 was: "Continue Restraint(s) Every Two Hours, Request Type: Stat, Restraint Type: Soft Limb x 1 ..." That order was repeated for ~ 24 hours periods beginning on 12/12/2023 at 1810 and ending on 12/20/2023 at 1000.
* An order written on 12/19/2023 to start at 2022 and end on 12/20/2023 at 1652 was: "Initiate Restraint(s) Every Two Hours, Request Type: Stat, Restraint Type: Soft Limb x 2, Restraint Indication: Unable to follow safety instructions ..."
* An order written on 01/09/2024 to start at 1319 and end on 01/10/2024 at 1200 was: "Continue Restraint(s) Every Two Hours, Request Type: Stat, Restraint Type: Soft Limb x 1, Restraint Indication: Unable to follow safety instructions, Comments: leg."

1.g. An Excel "Restraint forms" flowsheet reflected use of multiple restraints simultaneously for which physician's orders were not in place. For example:
* On 12/08/2023 at 0730 the flowsheet reflected that restraints for Soft Wrist x2, Freedom Splint x 2, Soft Limb x1 for an unspecified limb, and Soft Limb x 2 for unspecified limbs were all applied on the Right Arm and Left Arm which indicated multiple restraints on each arm at the same time. There were no physician's orders for a Soft Limb x1 restraint for an unspecified limb and Soft Limb x 2 restraints for two unspecified limbs.
* Flow sheet entries from 12/13/2023 at 1130 through 12/16/2023 at 0510 reflected restraints for Soft Wrist x 2, Freedom Splint x1 for an unspecified limb, and Soft Limb x1 for an unspecified limb were applied to the patient's Right Arm, Left Arm, and Right Leg. However, the physician's order for a Freedom Splint had been discontinued on 12/11/2023 at 1200 and the order for a Right Ankle restraint had been discontinued on 12/11/2023 at 1200.
* On 01/09/2024 at 0725 the flow sheet reflected that Soft Wrist x 1, Soft Wrist x2, and unspecified Soft Limb x1 restraints were all applied on the patients' Right Arm, Left Arm, and Right Leg. However, there were no physician's orders for wrist restraints or unspecified "leg" restraint until 01/09/2024 at 1319.

1.h. Physician's orders for bed side rails as a restraint for Patient 8 were incomplete and unclear, and the side rails were used as a restraint without an order. Further, the use of side rails for cognitively impaired patients who attempt to exit the bed on their own posed a risk of additional injury and harm. For example:
* An order written on 12/04/2023 to start at 1600 and end on 12/05/2023 at 1400 was: "Initiate Restraint(s) Every Two Hours, Request Type: Stat, Restraint Type: Full - 4 Side Rails, Restraint Indication: Prevent disruption of life sustaining intervention." That was the first of two orders for side rails in the record. There was no assessment or indication to reflect what the patient-specific purpose for the side rails. It was not clear how the use of 4 side rails would "prevent disruption of life sustaining intervention."
* An order written on 01/09/2024 to start at 1318 and end on 01/10/2024 at 1200 was: "Continue Restraint(s) Every Two Hours, Request Type: Stat, Restraint Type: Full - 4 Side Rails, Restraint Indication: Prevent disruption of life sustaining intervention." That was the second of two orders for side rails in the record.
* An Excel "Restraint forms" flowsheet reflected that "Full - 4 Side Rails" were documented as in place on 12/02/2023, 12/04/2023 through 12/07/2023, 12/17/2023 through 12/19/2023, and 12/24/2023 through 12/30/2023. On 12/04/2023 the time the side rails were documented was "0730." There were no orders for the side rails at that time on 12/04/2023 nor on any of the other dates.

1.i. Physician's orders for use of a restraint net bed for Patient 8 were incomplete and unclear, and the net bed was used without an order. For example:
* An order written on 01/10/2024 to start at 1330 and end on 01/11/2024 at 1200 was: "Initiate Restraint(s) Every Two Hours ... Stat, Restraint Type: Net Enclosure Bed, Restraint Indication: Unable to follow safety instructions ..." The order did not specify what was meant by "unable to follow safety instructions."
* Although the patient was restrained in the net enclosure bed for the remainder of the hospital stay there were no orders for the restraint on the following dates/times: 01/11/2024, 01/12/2024, 01/16/2024, 01/17/2024, 02/09/2024, 02/25/2024, 02/27/2024, 03/01/2024, 03/04/2024, 03/05/2024, and 03/06/2024.
* On 01/12/2024 at 0840 an RRT signed a note that reflected patient was "in a Posey bed." There was no order for the net enclosure bed at that time. The previous order for the restraint bed ended on 01/11/2024 at 1200 and the next order was written to start on 01/13/2024 at 0917.

1.j. On 01/15/2024 at 1603, 01/20/2024 at 1149, and 01/23/2024 at 1059, PT notes reflected "Precautions: ... bilateral UE restraints (can be off when [family] is in room), 1:1 sitter ..." At those times there were no physician orders in the record for bilateral restraints on the patient's upper extremities, or any restraints except for the net enclosure bed restraint.

1.k. During interview with the CMD at the time of the record review on 11/14/2024 beginning at ~ 1145 they stated that Patient 8 exhibited "violent, resistive, combative" behaviors during the hospitalization and multiple types of restraints were used to manage the behaviors. The hospital was provided with opportunity to submit any additional information it had or found related to the survey findings after the exit conference. In an email received on 02/28/2025 at 1003 the CMD confirmed that all restraint documentation was provided.

1.l. Refer to Tags A-164, A-166, A-171, A-175, A-395, and A-396 for Patient 8 related to the assessment and use of restraints.

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2. The P&P titled, "Restraint Use" with a revise date of "6/24" and a review date of "12/23" was reviewed and reflected:
* "Policy: Restraints are ordered ... by trained personnel in response to emergent, dangerous situations as an adjunct to planned care."
* "A Licensed Independent Practitioner (LIP)'s order is required to initiate, change, continue, and discontinue restraint. The order must include the type and number of restraints and duration."
* "Raised side rails - If a patient's status requires that all bedrails be raised (restraint) while the patient is in bed, a standing or PRN order is permitted. It is not necessary to obtain a new order each time the patient is returned to bed after being out of bed."
* "Orders: Restraints used to ensure the physical safety of the non-violent or non-self-destructive patient are renewed daily."

3.a. During a tour of the high-acuity medical unit on 11/13/2024, at 1353, Patient 15 was observed moving and crying out while lying in their bed and all four bed railings were raised. .

3.b. A review of Patient 15's orders dated "11/13/2024" and electronically signed by the LIP reflected:
* "Description: Continue Restraint(s) Every Two Hours, Request Type: Stat, Restraint Type: Soft Wrist Restraint x2, Restraint Indication: Pulling at tubing/dressing" with "Start Date: 11/13/2024 08:51" and "Stop Date: 11/14/2024 08:00."
* "Description: Continue Restraint(s) Every Two Hours, Request Type: Routine, Restraint Type: Mitts x2, Restraint Indication: Pulling at tubing/dressing" with "Start Date: 11/13/2024 10:00" and "Stop Date: 11/14/2024 08:00."
* There was no restraint order to engage all four railings on the patient's bed. This was verified during interview at the time of the observation by the RTM.

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PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0171

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0175

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Based on interview, review of medical record documentation for 1 of 1 patients reviewed for restraint monitoring and provision of care interventions (Patient 8), and review of hospital procedures it was determined that the hospital failed to ensure patient's rights to freedom from restraints. Documentation to reflect restraint monitoring, release, and provision of care interventions was not in accordance with procedures and did not ensure safe and appropriate care for the medically complex and vulnerable patient.

Findings include:

1.a. For Patient 8, in response to surveyor request for all restraint records, the "Restraint Order and Flow Record," on which restraint monitoring and care was documented, was provided for only 14 shifts on seven days of the patient's hospital stay. The "Restraint Order and Flow Record" was an electronic four-page form that consisted of two-pages for "Day Shift" followed by two-pages for "Night Shift. Refer to Tags A-164 and A-168 related to the use of multiple restraints that were initiated on 12/02/2023 and were ongoing throughout the patient's hospitalization until the date of discharge on 03/06/2024.

Directions on the restraint record required "RN's initials indicate that the required assessment was completed and care provided per Policy. Restraint Use: Minimally Q 2 hrs (or more frequently if condition warrants) the patient's safety and other needs are addressed which includes but is not limited to: *Guidelines for Restraint Application Followed *Circulation and Skin Integrity Not Compromised *Privacy/Modesty Preserved *Elimination Needs are Addressed *Physical Comfort is Addressed *Patient is Re-Positioned, Limb Restraint Removed or Rotated *Nutrition/Fluids Provided or Addressed *Personal Hygiene Needs are Addressed *Active/ Passive ROM is Facilitated and/or Provided."

1.b. The provision of every two-hour monitoring, restraint release, and care interventions identified above were denoted only by the recording of a time notation with the initials of the staff person who recorded the entry. There were no provisions on the record to record the specific observations made of the patient, nor the specific care interventions provided to the patient, nor release from restraints. Documentation of restraint use in accordance with physician's orders, and RN monitoring and provision of care interventions on those 14 shifts was unclear and incomplete. For example:
* On 01/08/2024 "Day Shift," the type of restraint was identified as "Soft Wrist Restraint x 2." However, the order for "Soft Wrist Restraint x 2" ended on 01/08/2024 at 1000 and was not ordered again until 01/09/2024 at 1319. The record was electronically signed by the RN on 01/08/2024 at 1944.
* On 01/08/2024 "Night Shift," the type of restraint was identified as "Soft Wrist Restraint x 1" and "Soft Wrist Restraint x 2." However, the "Placement" was recorded as "Right Arm" and "Left Arm" and "Right Leg." It was not clear where on the "leg" the patient was restrained. Physician's orders for bilateral wrist restraints were not effective until 01/09/2024 at 1319, an order for an unspecified "limb x 1" restraint was not effective until 01/09/2024 at 1319, and the "right ankle" restraint was discontinued on 12/11/2023 at 1200. In addition, the "RN Initials" for the every two-hour monitoring and care, and the "RN Name" for authentication of that section by the RN, were completed and authenticated by an LPN who electronically signed the record on 01/09/2024 at 0619.
* On 01/10/2024 "Night Shift," the type of restraint was identified as "Net Enclosure Bed." The "RN Initials" for the every two-hour monitoring and care, and the "RN Name" for authentication of that section by the RN, were completed and authenticated by an LPN who electronically signed the record on 01/11/2024 at 0619. The only narrative note on the form was under the "type" of restraint and reflected "order for net bed, but bed not available yet. still in bilateral wrist restraints and right leg restraint." However, the physician's orders for bilateral wrist restraints and unspecified "limb x 1" restraints were discontinued on 01/10/2024 at 1000, and the order for right "ankle" restraints was discontinued on 12/11/2023 at 1200.
* On 01/24/2024 at 1730 an "LPH [sic]" signed a nursing note that reflected "Pt remained in posey bed for entire shift." There was no "Restraint Order and Flow Record" for that date and it was unclear how the required "care provided per Policy" referenced in Finding 1.a. above could have been provided if the patient was in the net enclosure bed for the entire shift.
* On 01/25/2024 "Day Shift" the type of restraint was a "Net Enclosure Bed." The required monitoring and care had not been documented as done every two hours as required. The LPN documented that the activity was done at 0730 and not again until 0950, and it was done at 1120 and not again until 1358. The "RN Initials" for the every two-hour monitoring and care, and the "RN Name" for authentication of that section by the RN, were completed and authenticated by an LPN who electronically signed the record the next day on "01/26/2024" at 0729, .
* On 01/25/2024 "Night Shift" the record was completely blank.
* On 02/26/2024 "Night Shift" the type of restraint was identified as "Net Enclosure Bed." The required monitoring and care had not been documented as done every two hours as required. The RN documented that the activity was done at 2115 and not again until 2400; done on 02/27/2024 at 0145 and not again until 0400, and not again until 02/27/2024 at 0615. Further, the record was electronically signed by the RN on "02/26/2024" at 0645, ~ 24 hours prior to the last entry recorded on 02/27/2024 at 0615.
* A second record for 02/26/2024 "Night Shift" reflected the same RN recorded the monitoring and care and those time occurred at different times than were documented on the 02/26/2024 "Night Shift" record identified above. The RN documented the activity was done on 02/26/2024 at 1915 and not again until to 2130, not again until 02/27/2024 at 0045, it was done on 02/27/2024 at 0330 and not again until 0630. The RN electronically signed that record on "02/26/2024" at 2210, ~ eight hours prior to the last monitoring and care activity documented on 02/27/2024 at 0630.
* On 03/03/2024 "Day Shift" the record reflected an LPN recorded that the RN monitoring and care had not been done every two hours. The LPN documented the activity was done at 1330 and not again until 1630 which was the last entry for the "Day Shift." The LPN electronically signed the record on 03/03/2024 at 1811.
* On 03/03/2024 "Night Shift" the record reflected an LPN recorded that the RN monitoring and care had been done every two hours beginning on 03/03/2024 at 2036 and ending on 03/04/2024 at 0608. The LPN electronically signed the record on 03/04/2024 at 0639.
* A second record for 03/03/2024 "Day Shift" reflected someone recorded initials for every two-hour monitoring and care beginning on 03/03/2024 at 0800 and ending at 1600, which was the last entry for "Day Shift." The name of the author of those entries was not recorded and the record was not signed. The next monitoring and care was not recorded for ~ three hours until the "Night Shift" on 03/03/2024 at 1900.
* A second record for 03/03/2024 "Night Shift" reflected an LPN recorded that the RN monitoring and care had been done every two hours beginning on 03/03/2024 at 1900 and ending on 03/04/2024 at 0500. However, the LPN on "03/03/2024" at 0753, prior to the every two-hour monitoring and care that was recorded.
* Similar findings were identified on "Restraint Order and Flow Records" provided for 02/26/2024 "Day Shift" and 02/27/2024 "Day Shift" and "Night Shift."

1.c. An Excel "Restraint forms" flowsheet for Patient 8 contained documentation that reflected the patient was in some form of physical restraints for 95 days of their 97-day hospitalization, and on some days was in multiple types of restraints. There was no restraint documentation on the flowsheet for 01/12/2024 and 03/04/2024. The flowsheet contained some non-patient-specific aspects of assessment such as interventions attempted prior to restraint. However, the flowsheet did not include provisions for documentation of every two-hour monitoring, restraint release, and care interventions like those required by the "Restraint Order and Flow Record" described under Finding 1.a. above.

1.d. During interview with the CMD at the time of the record review on 11/14/2024 beginning at ~ 1145 they stated that Patient 8 exhibited "violent, resistive, combative" behaviors during the hospitalization and multiple types of restraints were used to manage the behaviors. The hospital was provided with opportunity to submit any additional information it had or found related to the survey findings after the exit conference. In an email received on 02/28/2025 at 1003 the CMD confirmed that all restraint documentation was provided.

1.e. Refer to Tags A-164, A-166, A-168, A-175, A-395, and A-396 for Patient 8 related to the assessment and use of restraints.

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RN SUPERVISION OF NURSING CARE

Tag No.: A0395

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Based on observations, interviews, review of medical record documentation for 13 of 13 patients reviewed for aspects of nursing assessment and supervision of care and services (Patients 2, 3, 5, 8, 9, 13, 15, 16, 17, 18, 21, 22, and 23), review of P&Ps, and review of incident and internal investigation documentation, it was determined that the RN failed to ensure that each patient's nursing and safety needs were met by ongoing assessment, observation, and monitoring, including in response to patient change of condition. The RN failed to ensure that all nursing personnel provided care and services in a manner that ensured the ongoing health and safety of the hospital's medically complex and vulnerable patients. Those failures included:
* Failure to conduct clear and complete initial and ongoing individualized assessment of patients' physical and psychosocial problems and needs, including in coordination with the assessments of other disciplines.
* Failure to coordinate the provision of nursing services with pharmacy, dietary, rehabilitation, and respiratory services.
* Failure to ensure timely response in reporting and follow-up to changes of patients' physical and psychosocial conditions.
* Failure to evaluate physician orders for completeness and possible errors, and follow-up with the provider for clarifications.
* Failure to ensure the provision of nursing services in accordance with physician's orders.
* Failure to supervise the provision of safe and appropriate nursing services including: ADLs, skin and wound care, medication administration, nutritional care including tube feedings, rehabilitative care, and respiratory care.

Findings include:

1.a. Review of Patient 2's medical record reflected they were admitted on 02/09/2022 with a primary diagnosis of "Acute Respiratory Failure with Hypoxia" and discharged on 03/30/2022. On 02/15/2022 at 1026, six days after the patient's admission, a PA H&P report reflected the "Reason for Admission" was "Chronic Respiratory Failure s/p trach, TBI" and that the patient was "Respiratory Complex ... Medically Complex ... [had] Functional Impairment ... Dysphagia ... Encephalopathy ... NPO ... non-responsive ... trach tube to mist ... PEG [feeding tube] ..."

The findings that follow reflect the RN failed to evaluate and assess, supervise, and coordinate the provision of care and services for Patient 2. For example:

1.b. On 02/26/2022 at 0833, 17 days after admission, an RN "Nursing Admission Assessment" reflected Patient 2's problems and needs included: "Morse Fall Scale ... High Risk; Action - Implement High Risk Fall Precautions ... Nonverbal ... Artificial Airway? Yes ... Tracheostomy Tube Type: ... Cuffed ... Risk Level for Skin Breakdown ... Moderate Pressure Injury Risk ... Any Wounds present? ... No ... Saline/Heplock #1 Left brachial ... Bladder incontinence: Always Incontinent ... external/condom catheter ... Bowel Continence: Always incontinent ... Peg Tube ... NPO ... OK to give pt small ice chips or teaspoons sips water PRN ..."

The RN admission assessment was not timely as identified above, and it was not complete or accurate. For example: Although the H&P and the RN admission assessment identified that problems for the patient included dysphagia, tube feeding and NPO, and high fall risk for example, the RN documented on the admission assessment that there were "No Precautions Indicated" for the patient. The following pre-printed "Precautions" and "Safety Measures" on the form were not checked and were left blank by the RN: "Fall Precautions" and "Aspiration Precautions" and "Fall Indicators" and "Fall precautions in place." In addition, the RN documented on 02/26/2022 in the admission assessment that the patient had no wounds. However, on 02/24/2022 at 1511, two days prior, an RN note reflected "Pt has an open wound on left knee ..."

1.c. Nursing documentation for Patient 2 reflected they were admitted with no wounds or skin alterations and were assessed as high risk for skin breakdown. The medical record reflected a lack of timely and complete RN assessment, response, and treatment for a wound that developed during the patient's hospital stay. Review of progress notes and physician's orders for Patient 2 revealed the following:
* On 02/10/2022 at 1017 an LPN Wound Care note reflected "Overall patients skin is intact with no observes [sic] signs of wounds noted at this time."
* On 02/22/2022 at 1702 an LPN Wound Care note reflected "patient skin remains stable at this time."
* On 02/24/2022 at 1511 an RN note reflected "Pt has an open wound on left knee [wound care staff] notified yet [sic] to evaluate the wound." There was no assessment of the wound at that time.
* On 02/26/2022 at 0833 an RN admission nursing assessment reflected the patient's mobility was "slightly limited," they had a "Moderate Pressure Injury Risk," and there were no wounds present on the patient. However, on 02/24/2022, two days prior, an RN identified that the patient had an "open wound" on their left knee.
* On 03/04/2022 at 0709 an LPN Wound Care note that was not identified as a "late entry" reflected that seven days earlier on "02/25/2022 1030 ... Left knee, there appears to be a potential abrasion to knee from other leg and devices against it. Cleansed with saline, patted dry. Applied adaptic dressing, covered and secured." Although the wound was identified originally on 02/24/2022 there was no assessment documented at that time, no investigation as to how it was allowed to occur, nor were there orders for treatment until 03/04/2022. Further, it was not clear what the status of the dressing the LPN had covered the wound with seven days earlier on 02/25/2022 was, and what the condition of the wound was at the time the LPN wrote this note on 03/04/2022.
* On 03/04/2022 at 1105 an LPN Wound Care note reflected "Left medial knee abrasion, removed dressing, cleansed with saline and patted dry. Wound bed 100% granulated tissue, edges well defined and attached to wound base, scant serous exudate and peri wound WNL. Applied 4x4 opti foam pad." The description of the wound did not include the size and depth.
* On 03/04/2022 a physician's order was written to start at 1107 for "Daily PRN ... Routine ... Left lateral knee abrasion: gently cleanse with saline, pat dry and apply 4x4."
* On 03/04/2022 at 1415 an RN note for an IDT Conference conducted on 03/01/2022 contained minimal information about the patient's problems and needs and included no information about the patient's open wound on the left knee.
* On 03/04/2022 at 1426 an RN note reflected a conference with the spouse had been conducted on 03/03/2022. The note reflected the spouse had "concerns [revolving] around nursing care, including oral care, trach care, correct tube feed/medication administration, and newly [sic] onset wound on patient's knee."
* On 03/04/2022 at 1549 an LIP note reflected "Wound care team feels L knee wound is significantly improved." However, it was not clear what that meant as there was no assessment of the wound documented prior to the date of the LIP's note, and no treatment ordered until the date of the LIP's note.
* On 03/10/2022 at 1117 a PT Wound Care note reflected "L knee abrasion. Wound measures 0.8x0.8 with scant serosanguinous drainage and indistinct wound margins. Wound dressed with several layers of skin barrier using spray and then mepitel one applied over the wound." That was the first documentation that included measurements of the wound. The treatment provided was not the current wound treatment ordered on 03/04/2022. Further, it was unclear what "several layers of skin barrier" meant.
* On 03/10/2022 a physician's order was written to start at 1133 to change the wound treatment to "Every 48 hours PRN ... Stat ... Left lateral knee abrasion: gently cleanse with saline, pat dry and spray a couple of layers of skin barrier to wound and surrounding area. Then cover with Mepitel One. Replace q 48 hrs or prn if dressing comes off." The order as written was unclear about what "a couple layers of skin barrier" meant. The treatment documented prior to the initiation of the order reflected that "several layers of skin barrier" were applied. A "couple" and "several" have different meanings that may be interpreted differently by different individuals.

The "Wound Care Clinical Assessment Documentation" form in Patient 2's record was blank and there was no formal wound assessment documented elsewhere in the record. There was no RN assessment of the patient's wound during the hospitalization. According to the documentation the only RN who observed the wound, on 02/24/2022, deferred the assessment to an LPN.

1.d. The medical record for Patient 2 reflected the RN failed to supervise the provision of care and services to ensure physician's orders were written for diagnostic testing, that reports with the results of diagnostic testing were received and reviewed timely, and that nursing assessment was conducted as applicable. Documentation reflected an EEG was conducted, however, there were no physician's orders for an EEG and there was no EEG report found in the record. For example:
* On 03/04/2022 at 0928 an LIP note reflected "The most recent imaging including CT head, EEG, and MRI of brain and spine were reviewed ... [perform] EEG if exam fluctuation noted ... 3/3 - ... EEG read not back pending. Initial read no seizures."
* On 03/04/2022 at 1415 an RN note for an IDT conference conducted on 03/01/2022 reflected "Patient is a slow trach wean. Although patient has preferential eye closure with [their spouse] and hearing aids in - allowing [them] to follow commands on [their] right side - [their] mentation does not support decannulation. [The patient's] slight decrease in alertness causes [them] to have difficulty in following commands and therefore prevents [them] from participating in therapy. An EEG was ordered due to wax/wane for follow-up on Keppra [anti-epileptic drug]."

There was no documentation of an order for an EEG in Patient 2's medical record. Nor was there documentation of an EEG procedure or an interpretation of an EEG procedure.

1.e. During interview with the CMD at the time of the record review for Patient 2 on 11/12/2024 beginning at 1230 they confirmed findings identified in this Tag that included wound development and documentation, and the EEG. They stated there was no other wound documentation for this patient. In an email from the CMD received on 02/28/2025 at 1006 they further confirmed that all wound documentation was provided.

2.a. Review of Patient 3's medical record reflected they were admitted to the hospital on 10/26/2022 and discharged on 01/30/2023. On 10/28/2022 at 0730 an MD H&P included the following information about the patient's condition: "Reason for Admission: TBI ... [Ventilator Weaning] ... Medically Complex ... Respiratory Complex ... Functional Impairment ... DVT ... Quadriplegia/Quadriparesis ... Dysphagia ... Wounds [Section was not completed] ... Acute Respiratory Failure ... Trach/ET Tube .... Pneumonia ... Encephalopathy ... MRSA ... NPO EXCEPT ICE Daily ... Upright position ... Continues to require TLSO at all times and care complicated by urinary retention and neuroconstipation ... aggressive rehab services to include PT/OT ... Foley in place and no evidence of [bladder outlet obstruction]. Will plan for voiding trials to start tomorrow ... Chronic Pain Syndrome - pain currently well controlled ... Dysphagia with PEG dependency - TF order ... Current Pain score and description - Pain Score (1 to 10): 0 ..."

The findings that follow reflect the RN failed to evaluate and assess, supervise, and coordinate the provision of care and services for Patient 3. For example:

2.b. On 10/27/2022 at 0301 an RN Nursing Admission Assessment for Patient 3 reflected their problems and needs included: aspiration precautions, contact isolation Precautions, MRSA infection, high risk fall precautions, experiencing pain, agitated, DVT risk assessment score "7" with direction for "3 or Greater: Notify Physician," HOB elevated, daily suction, two surgical incisions (one on chest and one on back) and a "pressure" wound on their "coccyx" for which there were no descriptions or sizes and the "color, odor, drainage, comments" sections of the assessment were blank, "moderate" skin breakdown risk, three IV sites (left arm, left foot, right foot), bladder incontinence, Foley catheter, bowel incontinence, PEG feeding tube, NPO, dependent for ADLs including personal care and mobility and positioning, continuous oxygen, and ventilator.

2.c. The admission nursing assessment signed by the RN on 10/27/2022 reflected that Patient 3 was dependent for ADLs and was incontinent of stool. The RN failed to supervise the provision of ADL care provided to the Patient 3. For example:
* The "Patient Rounding and ADLs" flowsheet reflected that personal care, bathing, and incontinence care were not provided by staff on 64 of 96 days during the hospital stay. There were no bathing, incontinence care, or perineal care tasks documented on the flowsheet as provided on the following dates:
- In October of 2022 on 10/26/2022 and 10/31/2022.
- In November of 2022 on 11/01/2022, 11/04/2022 through 11/06/2022, 11/08/2022 through 11/10/2022, 11/12/2022, 11/14/2022 through 11/17/2022, 11/19/2022 through 11/25/2022, 11/27/2022 through 11/30/22.
- In December of 2022 on 12/02/2022 through 12/06/2022, 12/09/2022 through 12/11/2022, 12/15/2022 through 12/18/2022, 12/22/2022 through 12/24/2022, 12/27/2022, 12/28/2022, 12/30/2022 and 12/31/2022.
- In January of 2023 on 01/02/2023 through 01/04/2023, 01/06/2023, 01/07/2023, 01/09/2023, 01/10/2023, 01/12/2023, 01/13/2023, 01/15/2023 through 01/20/2023, 01/24/2023 through 01/27/2023, 01/29/2023, and 01/30/2023.

* Bathing and ADL tasks were documented as provided by family members. However, there was no indication that the RN had discussions with family to assess why those tasks were being performed by the family, including to evaluate whether the provision of that care had been appropriately and sufficiently provided by hospital staff. Further, there was no indication that the RN had evaluated whether the family was trained and competent to provide safe and appropriate care for this dependent patient.
- CNA staff entered notes on the ADL flowsheet that reflected family members provided bathing/ADLs on 11/26/2022 at 1539, 12/02/2022 at 0845, 12/25/2022 at 1430, 12/29/2022 at 1216, 01/08/2023 at 0930, 01/10/2023 at 0920, 01/14/2023 at 0815, and 01/22/2023 at 0930.
- A Nurses Note signed by a CNA on 12/12/2022 at 0938 reflected that "Bed Bath completed by [patient's family] - supply set up by [CNA]."
- On 12/25/2022 at 0904 an LPN signed a note that reflected "Pts [parent] helping with personal care and repositioning pt."
- A Nurses Note signed by an LPN on 12/28/2022 at 1556 reflected "Rapid Response was called @ 1455 - [Family] at bedside doing personal care on patient ... [patient] slowly started turning away ... [family] was able to get to the other side of the bed and guide patient to the floor to prevent any injuries from occurring. Nursing staff and MD assessed patient ... Patient's knees were slightly red and skinned."

2.d. The RN failed to assess Patient 3's wound/skin needs throughout the hospital stay, failed to ensure physician's orders for treatment were clear, and failed to supervise the provision of wound care and prevention interventions. For example:
* The admission nursing assessment signed by the RN on 10/27/2022 reflected that the Patient 3 had surgical incisions on their chest and back, and a "pressure" wound on their "coccyx." There was no description or size or stage for the coccyx pressure wound. The "color, odor, drainage, comments" sections of the assessment were blank. The "Risk Level for Skin Breakdown" was assessed as "Moderate."
* On 10/27/2022 physician's orders were written for: "Right and Left Chest Surgical" incisions, "Sacral MASD [Moisture-associated skin damage]," "Right Medial Distal Foot and Right Foot Pinky Toe DTI [Deep tissue injury]," and "Occipital Head Unknown" wounds. All of those wounds were not identified on the admission nursing assessment conducted on the same day as the orders, and there were no orders for the pressure sore on the patient's coccyx that had been identified in the nursing assessment.

* Physician's orders for treatment to the sacral wound were not clear and not followed:
- A 10/27/2022 physician's order to start at 0900 was for "Wound Care Treatment Every 12 Hours PRN, Comments: SACRAL MASD: wash with NS and pat dry, apply calazime and hydraguard every shift and PRN soiling/displacement. Notify WOT of changes Indication: wound." The order was discontinued on 11/04/2022. It was unclear if Calazime paste and Hydraguard cream were to be applied without a dressing, or if Calazime and Hydraguard came in any other form other than a paste and a cream.
- A 10/27/2022 physician's order to start at 1000 was for "Bacitracin 500 UNIT/G - 28GM (Bacitracin) 500 UNIT/G, Apply topically Daily SACRUM MASD: See WOT orders (Pharmacy to fill bulk item; 28.4g ointment) Indication: wound." The was order discontinued on 11/10/2022. It was not clear how the order for Bacitracin ointment daily was to be used and applied in conjunction with the Calazime and Hydraguard every shift ordered one hour prior.
- An 11/10/2022 physician's order was for "Wound Care Treatment Daily PRN, Comments: SACRAL MASD: wash with NS and pat dry, apply xeroform cut to slightly larger than wound size. Cover with 6 inch optifoam. Change daily and prn for soiling. Indication: wound."
- An 11/17/2022 physician's order was for "Wound Care Treatment Daily PRN, Comments: SACRAL MASD: wash with NS and pat dry, Squeeze a small amount of hydrogel onto the wound and cover with 4inch optifoam. Change daily and prn for soiling. Indication: wound."
- On 12/07/2022 at 1304 an LPN signed a note that reflected "[A&D ointment] applied to sacral treatment per [family] request. [Family] stated wound has not improved since hydrogel application." There were no orders for A&D ointment to the patient's sacral wound. It was not clear why the LPN determined that they would follow instructions from a family member rather than administer the treatment the physician had ordered on 11/17/2022.

* Physician's orders for treatment of an "Unknown" head wound were not clear and not followed:
- A 10/27/2022 physician's order was for "Wound Care Treatment Daily PRN, Comments: OCCIPITAL HEAD UNKNOWN: Wash with baby shampoo and dry thoroughly, apply thin layer of bacitracin every day and PRN soiling/displacement. notify WOT of changes Indication: wound."
- On 11/06/2022 at 2037 an LPN signed a note that reflected "Wound care done ... Bacitracin applied to occip. after cleansed with NS and pat dried." The 10/27/2022 order was for a wash with baby shampoo prior to the application of Bacitracin.
- On 11/24/2022 at 1451 an LPN signed a note that reflected "Wound care done .. bacitracin applied to wound on scalp." It was not clear whether the complete order that required a wash with baby shampoo had been carried out.

* Physician's orders for Bacitracin to an unspecified "wound(s)" were not clear. The wound(s) were not specified nor was it clear what the unspecified "See WOT Orders" meant.
- An 11/04/2022 physician's order was for "Bacitracin (Bacitracin) 500 UNIT/G, Apply topically Daily See WOT Orders ... Indication: wound"
- A 12/01/2022 physician's order was for "Bacitracin (Bacitracin) 500 UNIT/G, Apply topically Daily See WOT Orders ... Indication: wound"
- A 12/29/2022 physician's order was for "Bacitracin (Bacitracin) 500 UNIT/G, Apply topically Daily See WOT Orders ... Indication: wound"

* On 11/07/2022 at 2003 an LPN signed a note that reflected "[Family] pointed out skin breakdown to coccyx, nurse notified WOT. Advised to place calazime ointment and cover with dressing." There was no RN assessment to identify the type and extent of skin breakdown in the nurses's notes, and there were no physician's orders for Calazime or any other treatment to a coccyx wound.

* On 11/28/2022 at 1556 an LPN signed a note that reflected that during personal care the patient fell out of bed and their "knees were slightly red and skinned ... Bactrian [sic] ointment and ice pack were placed on knees." There was no RN assessment of the wounds to the patient's bilateral knees in nursing notes, nor evidence of a physician's order for "Bactrian [sic] ointment" or any other treatment to those knee wounds.

* On 12/07/2022 at 1314 an LPN signed a note that reflected "Pt c/o Peg site pain during cleaning, Bacitracin applied." There were no physician's orders for Bacitracin to the patient's PEG site.

* Regarding a large blister identified on the patient's heel there was lack of initial RN assessment of the cause of the blister that developed in the facility, and ongoing RN assessment of wound healing. In addition, physician's orders for treatment were not clear and it was not clear whether those were carried out. The blister wound had not healed at the time of discharge nearly eight weeks later:
- On 12/07/2022 at 1314 an LPN signed a note that reflected "Blister to right heel intact, [Family] has marked redness [sic] and redness has not spread since yesterday." It was not clear when this blister had been originally identified and there was no indication of an RN assessment of the blister or of the "redness" associated with it.
- On 12/08/2022 the first physician's order for the heel was written for "Wound Care Treatment Every 12 Hours PRN ... Right Lateral Heel Unknown: Keep clean and dry. Protect from trauma and float heels every shift and PRN Indication: wound." It was not clear what "... Heel Unknown" in conjunction with "wound" meant. It as not clear if there was a wound and if so, what type.
- On 12/08/2022 at 1324 an LPN signed a "Wound Team Visit" note that reflected "Blister ... Wound Measurement ... [3 cms length by 4 cms width] ... Right Heel." There was no documentation to reflect whether provisions to "float heels" had been made in accordance with the physician's order.
- On 12/08/2022 at 1448 an LPN signed an "RN Shift Wound Assessment" that reflected "Medical device related to pressure injury? N/A ... Heel Protectors: [No] ... Right Heel." There was no documentation to reflect whether provisions to "float heels" had been made.
- On 12/15/2022 at 0924 an LPN signed a "Wound Team Visit" note that reflected "Blister ... Wound Measurement ... [4.5 cms length by 3.5 cms width] ... skin intact but partial thickness wound d/t blister with serous liquid ... Right Heel." There was no documentation to reflect whether the patient's heels were "floated" per the physician's orders.
- On 12/23/2022 at 2214 an LPN signed an "RN Shift Wound Assessment" that reflected "No measurement required for this skin finding ... Heel Protectors: [No] ... Right Heel." There was no documentation to reflect whether the patient's heels were "floated" per the physician's orders.
- On 12/23/2022 at 2220 an LPN signed a note that reflected "Right heel visualized by this LN, [open to air] at this time and intact."
- On 12/25/2022 at 0924 LPN "Pt [family] at bedside, discussed blister on R heel and keeping pts feet floated off of bed. Pts [parent] helping with personal care and repositioning pt ..." That note contained the only reference in the nursing notes to floating the patient's heels.
- On 12/27/2022 a physician's order was written for "Wound Care Treatment Daily ... Right Lateral Heel Unknown: Keep clean and dry. Apply layer of betadine and leave [open to air], Protect from trauma and float heels every shift and PRN Indication: wound." It was not clear what "... Heel Unknown" in conjunction with "wound" meant. It was not clear if the betadine was to be applied to a "blister" or to a wound that resulted from a broken blister.
- On 12/27/2022 at 1733 an LPN signed a "Wound Team Visit" note that reflected "Blister ... Wound Measurement ... [4.5 cms length by 3 cms width] ... skin intact but partial thickness wound d/t blister with serous liquid ... Right Heel." There was no documentation to reflect whether the patient's heels were "floated" per the physician's orders. That documentation was also lacking for all subsequent "Wound Team Visit" notes and "RN Shift Wound Assessments."
- On 12/30/2022 a physician's order was written for "Wound Care Treatment Daily PRN ... Right Lateral Heel Unknown: Keep clean and dry. Apply layer of betadine and leave [open to air], Protect from trauma and float heels daily and PRN Indication: wound."
- On 01/03/2023 at 1611 an LPN signed a "Wound Team Visit" note that reflected "Blister ... Wound Measurement ... [3.3 cms length by 4.6 cms width] ... partial thickness d/t reabsorbed blister having reabsorbed leaving layer of non-attached dry callous ... Right Heel."
- On 01/11/2023 at 1253 an LPN signed a "Wound Team Visit" note that reflected "Blister ... Wound Measurement ... [3.8 cms length by 4.2 cms width] ... partial thickness d/t reabsorbed blister having reabsorbed leaving layer of non-attached dry callous ... Right Heel."
- On 01/18/2023 at 1804 an LPN signed a "Wound Team Visit" note that reflected "Blister ... Wound Measurement ... [3.4 cms length by 4.2 cms width] ... partial thickness d/t reabsorbed blister having reabsorbed leaving layer of non-attached dry callous ... Right Heel."
- On 01/23/2023 at 1616 an LPN signed an "RN Shift Wound Assessment" that reflected "Medical device related to Pressure injury? N/A ... No measurement required for this skin finding ... Heel Protectors: [No] ... Right Heel."
- On 01/25/2023 at 1436 an LPN signed a "Wound Team Visit" note that reflected "Blister ... Wound Measurement ... [3.2 cms length by 3.8 cms width] ... partial thickness d/t reabsorbed blister having reabsorbed leaving layer of non-attached dry callous ... Right Heel."
- On 01/30/2023 at 0229, the day of the patient's discharge, an RN signed a note that reflected "Will do [patient's right heel wound] care in [morning] ... " The nurse's notes did not reflect that the treatment was provided later that morning.
- The "Patient Rounding and ADL" flowsheet contained no documentation to reflect that the patient's heels were floated, or that heel protection had been provided, at any time during the patient's hospital stay.

* The RN failed to clearly assess and coordinate Patient 3's wound needs throughout the patient's hospital stay. For example: IDT Conference Form notes for "Date of Team Conference" 01/11/2023 reflected that was the first IDT Conference documented for Patient 3 who had been admitted on 10/27/2022. The entire "Nursing" section of the conference form was blank, including the spaces that referenced wound issues: "Wound care which required extensive time for treatment" and "Nursing goals/plan of care/actions" to "Resolve improve wounds." The "Nutrition" section of the form was also blank, including for "Nutrition goals/plan of care/actions" for "Improved wound healing." The "Wound Care" section of the form reflected that "Yes" there was "Wound Care on Service." Documentation in that section reflected there was "[one]" wound identified as a "Pressure Ulcer" for which there was no location and description (depth, size, character, drainage). Further, there was no indication whether interventions were effective and what the progress towards wound related goals was at the time of the conference.

* Regarding other physician's orders to prevent skin breakdown for Patient 3, it was not clear that they had been followed:
- A physician's order on 10/27/2022 for "Low Air Loss Mattress Continuously ... Alternating pressure loss every 10 [minutes] ..." was discontinued on 01/03/2023. The Personal Care Flow Sheet reflected that a "Specialty Mattress" was in place for the patient on 10/31/2022 at 0816 only.
- A physician's order on 01/04/2023 for "Low Air Loss Mattress Continuously ... Alternating pressure loss every 10 [minutes] ..." was discontinued on 01/30/2023. The Personal Care Flow Sheet reflected that a "Specialty Mattress" was in place for the patient again only on 01/29/2023 at 0920.

2.e. The RN failed to supervise the provision of bladder scans and straight catheterization for Patient 3 to ensure clear and accurate information, clear physician's orders, and conformance with physician's orders. For example:
*The admission nursing assessment signed by the RN on 10/27/2022 reflected the patient was incontinent of urine and had an indwelling Foley catheter present. A physician's order on 10/29/2022 was written for "FOLEY CATH REMOVAL ..."
* Physician's orders for bladder scans and straight catheterization were not always clearly written or followed:
- A physician's order on 10/29/2022 was written for "Bladder Scan Every Six Hours PRN ... If no urine output over 6 hours period, obtain bladder scan and if greater than 250 mL perform in and out cath and record urine volume recovered. Indication: urinary retention." This order was discontinued on 11/16/2022.
- A physician's order on 10/29/2022 was written for "Straight Catheter Every Six Hours PRN ... Indication: urinary retention." This order was discontinued on 11/22/2022.
- A physician's order on 11/17/2022 was written for "Bladder Scan Every Four Hours ... Routine ... If no urine output over 4 hours period, obtain bladder scan and if greater than 250 mL perform [straight] cath and record urine volume recovered. Indication: urinary retention." It was discontinued on 12/27/2022.
- A physician's order on 11/22/2022 was written for "Straight Catheter Every Six Hours PRN ... [post void residual greater than] 550 ml Indication: urinary retention." It was discontinued on 01/30/2023. It was not clear how this order for straight cath every six hours PRN was to be carried out in conjunction with the 11/17/2022 order, in effect until 12/27/2022, for bladder scan every four hours routinely and straight cath based on those every four hour results.
- A physician's order on 12/27/2022 was written for "Bladder Scan Every Six Hours PRN ... if no urine output over 4 [hour] period. If scan [post void residual greater than] 450 mL perform in /out catheterization and record volume recovered ..." This order was discontinued on 01/30/2023. It was not clear how this order for a bladder scan every six hours was to be carried out when the timeframe for the measurement of the urine output was four hours. As written, the order required that if the patient had no urine output for four hours, and had had a bladder scan four hours prior, a bladder scan could not be done for two more hours.
* Documentation on the "Patient Rounding and ADLs" flowsheet, fluid "Output" records, and nursing notes related to the patient's urinary output, bladder scanning, and straight catheterization did not clearly reflect conformance with physician's orders. For example:
- On 11/01/2022 at 1030 an ADL flowsheet note reflected "Bladder scan done: 602 ml, nurse notified." The 10/29/2022 order in effect at that time was for straight cath if bladder scan results showed greater than 250 mLs. However, the fluid "Output" record did not reflect any urine output measurement after the bladder scan until 1847, more than eight hours later. On 11/01/2022 at 1755 an ADL flowsheet note reflected "Bladder scan done: 646 ml, nurse notified." The fluid "Output" record reflected the patient's urinary output was measured at 1847 for an amount of 1350 mLs at that time.
- On 11/26/2022 at 1150 the fluid "Output" record reflected "bladder scan at 1200 - 507 ml retained" and that the "[amount] from urinary cath" at 1250 was 500 mLs. Although the 11/17/2022 bladder scan order in effect was for a bladder scan every four hours if no urine output, the next time urinary output was documented on the "Output" record was at 1859, ~ seven hours later. Further, a nursing note signed by an RN on 11/262022 at 1907 reflected "bladder scanned q6, straight cathed twice.
- On 12/18/2022 at 1533 an ADL flowsheet note reflected "performed bladder scan--WNL." It was not clear what "WNL" meant in relation to the physician's orders. Particularly when the 11/17/2022 order in effect for bladder scan required straight cath for residual urine more than 250 mLs and the 11/22/2022 order for straight cath in effect was for residual greater than 550 mLs. A nursing noted signed by an LPN on 12/28/2022 at 1644 reflected "Bladder scanned at 1451 with 297mL ... No straight cath required." According to the 11/17/2022 order a strai

NURSING CARE PLAN

Tag No.: A0396

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Based on observation, interview, review of medical record documentation for 11 of 11 patients reviewed for plan of care development and implementation (Patients 2, 3, 5, 8, 9, 13, 15, 17, 18, 21, and 22), and review of P&Ps it was determined the hospital failed to ensure the RN developed and kept current a care plan based on clear and complete assessment of the patient's individualized problems and needs. The plans of care did not reflect the myriad and complexity of the patients' medical, physical, and psycho-social problems and needs, did not include patient-specific goals, and did not reflect patient-specific interventions for nursing services that were coordinated with the assessments and plans of the other disciplines involved to ensure safe and appropriate care.

Findings include:

1.a. Review of Patient 2's medical record reflected they were admitted on 02/09/2022, discharged on 03/30/2022, and had problems and needs that included, for example:
* On 02/09/2022 a physician's order to treat oral thrush was written for the anti-fungal "nystatin ... per tube Four Times Daily" for 10 days to start on 02/09/2022.
* On 02/10/2022 at 1017 an LPN signed a note that reflected "Overall patients skin is intact with no observes [sic] signs of wounds noted at this time."
* On 02/15/2022 at 1026 a PA signed a H&P report that reflected the "Reason for Admission" was "Chronic Respiratory Failure s/p trach, TBI" and that the patient was "Respiratory Complex ... Medically Complex ... [had] Functional Impairment ... Dysphagia ... Encephalopathy ... NPO ... non-responsive ... trach tube to mist ... PEG [feeding tube] ..."
* On 02/16/2022 a physicians order was written for "[Passy-Muir speaking valve] Eval & Treat per ST Plan of Care ... PMV on during day as tolerated."
* On 02/22/2022 at 1702 an LPN signed a noted that reflected "HOB up for TF resumption."
* On 02/24/2022 at 1511 an RN signed a note that reflected "Pt has an open wound on left knee [wound care staff] notified yet to evaluate the wound."
* On 02/26/2022 at 0833 an RN signed a Nursing Admission Assessment that reflected the patient's problems and needs included: "Morse Fall Scale ... High Risk; Action - Implement High Risk Fall Precautions ... Nonverbal ... Artificial Airway? Yes ... Tracheostomy Tube Type: ... Cuffed ... Risk Level for Skin Breakdown ... Moderate Pressure Injury Risk ... Any Wounds present? ... No ... Saline/Heplock #1 Left brachial ... Bladder incontinence: Always Incontinent ... external/condom catheter ... Bowel Continence: Always incontinent ... Peg Tube ... NPO ...OK to give pt small ice chips or teaspoons sips water PRN ..."
* On 03/04/2022 at 1415 an RN signed a note that reflected the patient's "slight decrease in alertness causes [them] to have difficulty in following commands and therefore prevents [them] them from participating in therapy."
* On 03/07/2022 at 1730 an COTA signed an Interdisciplinary Team Conference Note that reflected the patient was "[total assist]" for upper body self care, lower body self car, and toileting, and "Participation barriers" were "impaired cognition secondary to TBI."
* On 03/11/2022 at 0827 an RN signed a note that reflected "Patient restless ... I putted [sic] on soft bilateral restraints at 0530 ... patient also vomited coffee color medium size, [their] bed was on 35 degrees at a [sic] time ..."
* On 03/14/2022 at 1401 a SLP signed an Interdisciplinary Team Conference Note that reflected "PMV as tolerated; not capped due to tendency to cough up secretions to back of throat."
* On 03/16/2022 at 2028 an RN signed a note that reflected "4 siderails up and in place."
* On 04/07/2022 at 1602 a PA signed a "Provider Discharge Summary" that reflected the following information about the patient's condition at discharge that included: "tracheostomy in place ... PEG in place ... L knee - dressing [clean, dry, intact] ... neurologic: ... not following commands, Unchanged ... continues to pull at O2 at times - trialing out of mittens ... PEG ... NPO ..."

1.b. Patient 2's "Plan of Care Complete Plan" was not clear and complete, not patient-specific, had not been updated throughout the patient's stay, and had not been coordinated with the other disciplines to ensure the provision of safe and appropriate care. For example:
* "Problem 1" was dated 02/10/2022 and was for "Alteration in ADL related to cognitive impairment as evidenced by ADL decline, decrease in ADL activities." There were no "Goal" statements. "Interventions" included "1. Provide and encourage use of assistive devices during ADL activities. 2. Encourage safe use of orthotic devices including donning and doffing ... 4. Educate patient/caregiver regarding safe self-care techniques and use of equipment related to ADL activities." The problem statement and the interventions did not address the patient's total dependence on ADLs, personal care, hygiene, dressing, mobility, positioning, etc. Nor did it include goals and interventions to ensure that nursing services were coordinated with those for PT and OT.

* "Problem 2" was dated 02/10/2022 and was for "Alteration in Respiratory Function related to trauma as evidence by increased work breathing." There were no "Goal" statements. "Interventions" were only "1. Suction patient as needed" and "2. Educate patient/caregiver regarding disease process, pulmonary condition and pulmonary medications." The patient's actual problems/needs related to all aspects of tracheostomy and trach mist care and management were not addressed.

* "Problem 3" was dated 02/10/2022 and was for "Alteration in Cognition related to post neurological procedure/surgery as evidence by altered cognition, inability to follow directions". There were no "Goal" statements. There were no patient-specific interventions.

* "Problem 4" was dated 02/10/2022 and was for "Potential for Skin Breakdown related to incontinence, altered mobility as evidenced by Braden Score less than 16." "Interventions" included to "1. Change patient position in bed every 2 hours ... 4. Keep skin free of urine and/or feces with cleansing immediately after incontinence or soiling ... 5. Incontinence care to skin and apply moisture barriers ..." Those interventions were the only ADL related interventions on the plan of care and had not been effective as the patient developed skin breakdown in the hospital. Further, the care plan had not been updated to include a problem, goals, and interventions for the actual wound/skin breakdown the patient developed in the hospital.

* "Problem 5" was dated 02/12/2022 and was for "Alteration in Mobility related to paraplegia, balance problem, CVA, trauma as evidenced by unsteady gait, limited endurance, history of falls, limited ROM, decreased activity/mobility, decreased muscle strength, loss of voluntary movement." The "Goal" statements were "1. Patient/caregiver to demonstrate understanding regarding mobility devices and adaptive equipment as appropriate ... 2. Patient / caregiver to be able to demonstrate all mobility activities with appropriate safety awareness ... 3. Patient to ambulate 150 feet with SPV [unclear acronym] assistance and 2WW as needed for community re-entry ..." "Interventions" included "1. Encourage exercise and activity to increase lower body strengthening ... 3. Gait training ... 4. Bed mobility training ..." The problem statement, goals, and interventions were did not clearly reflect the mobility related problems and needs of this patient.

1.c. Patient 2's care plan failed to address the myriad of the patient's problems and needs on admission and during the hospital stay, including for example: Tracheostomy, oxygen care and management, PMV use and it's care and management, IV line care and management, feeding tube for nutrition, HOB positioning, Dysphagia, NPO, use of ice chips, total dependence for ADLs and mobility, actual skin breakdown, oral care and treatment of thrush, fall risk, bowel/bladder incontinence and use of external condom catheter, fluctuating level of alertness, behaviors of pulling at tubing and use of mitts on the hands, use of bilateral wrist restraints, use of four side rails, etc. There were no entries on the care plan after 02/12/2022.

1.d. During interview with the CMD on 11/12/2024 beginning at 1230 they confirmed that Patient 2's care plan was not complete, including that it did not address the patient's skin/wound problems and needs.

2.a. Review of Patient 3's medical record reflected they were admitted to the hospital on 10/26/2022, discharged on 01/30/2023, and had problems and needs that included, for example:
* On 10/27/2022 at 0301 an RN signed a Nursing Admission Assessment that reflected the patient's problems and needs included: aspiration precautions, contact isolation precautions, MRSA infection, high risk fall precautions, experiencing pain, agitation, DVT risk assessment score "7" with direction for "3 or Greater: Notify Physician," HOB elevated, daily suction, two surgical incisions (one on chest and one on back) and a "pressure" wound on their "coccyx" for which there were no descriptions or sizes and the "color, odor, drainage, comments" sections of the assessment were blank, "moderate" skin breakdown risk, three IV sites (left arm, left foot, right foot), bladder incontinence, Foley catheter, bowel incontinence, PEG feeding tube, NPO dependent for ADLs including personal care and mobility and positioning, continuous oxygen, and ventilator.
* On 10/28/2022 at 0730 an MD signed an H&P that included the following information about the patient's condition: "Reason for Admission: TBI ... [Ventilator Weaning] ... Medically Complex ... Respiratory Complex ... Functional Impairment ... DVT ... Quadriplegia/Quadriparesis ... Dysphagia ... Wounds [Section was not completed] ... Acute Respiratory Failure ... Trach/ET Tube .... Pneumonia ... Encephalopathy ... MRSA ... NPO EXCEPT ICE Daily ... Upright position ... Continues to require TLSO at all times and care complicated by urinary retention and neuroconstipation ... aggressive rehab services to include PT/OT ... Foley in place and no evidence of [bladder outlet obstruction]. Will plan for voiding trials to start tomorrow ... Chronic Pain Syndrome - pain currently well controlled ... Dysphagia with PEG dependency - TF order ... Current Pain score and description - Pain Score (1 to 10): 0 ..."
* On 10/27/2022 four physician's orders were written that required specific wound care treatments to the "Right and Left Chest Surgical" incisions, "Sacral MASD [Moisture-associated skin damage]," "Right Medial Distal Foot and Right Foot Pinky Toe DTI [Deep tissue injury]," and "Occipital Head Unknown" wounds.
* On 10/27/2022 a physician's order was written that required "NPO EXCEPT ICE Daily ... Upright position ..." and physician's orders on 11/28/2022 and 12/06/2022 required "General Diet ... Upright w/ TLSO on; 1:1 assist."
* On 10/29/2022 a physicians' order was written that required "Straight Catheter Every Six Hours PRN ... Indication: urinary retention and "Bladder Scan Every Six Hours PRN ... If no urine output over 6 hours period, obtain bladder scan and if greater than 250 mL perform in and out cath and record urine volume recovered. Indication: urinary retention."
* On 11/28/2022 at 1556 an LPN signed a note that reflected "Rapid Response was called @ 1455 - [Family] at bedside doing personal care on patient ... [patient] slowly started turning away ... [family] was able to get to the other side of the bed and guide patient to the floor to prevent any injuries from occurring. Nursing staff and MD assessed patient ... Patient's knees were slightly red and skinned."
* On 12/08/2022 a physician's order was written that required the "Right Lateral Heel: Keep clean and dry. Protect from trauma and float heels every shift and PRN Indication: wound."

2.b. Patient 3's "Plan of Care Complete Plan" was not clear and complete, not patient-specific, had not been updated throughout the patient's stay, and had not been coordinated with the other disciplines to ensure the provision of safe and appropriate care. For example:
* "Problem 1" was dated 10/27/2022 and was for "Potential for Skin Breakdown ..." with a goal of "Skin to remain intact without evidence of breakdown ...". "Interventions" included "1. Inspect skin every ____ hours" and "2. Change patient position in bed every ____ hours." The care plan interventions also included "6. Keep skin free of urine and/or feces with cleansing immediately after incontinence or soiling ... 7. Keep skin free of urine and/or feces with cleansing immediately after incontinence or soiling Discontinue 10/27/2022." The care plan was incomplete and unclear. Spaces for patient specific intervention information had not been completed. Intervention "6" had been the only reference on the entire care plan to the patient's ADL needs however it was discontinued on the same date.

* "Problem 3" was dated 10/27/2022 and was for "Alteration in Respiratory Function related to trauma, decreased lung compliance, excessive or thick secretions, Pneumonia as evidenced by increased work of breathing, low oxygenation on room air." ..." with a goal of "Patient will maintain oxygenation at _____%." The "Interventions" were "1. Assess/auscultate lung sounds every _____ hours 2. Monitor respiratory rate, depth, and efforts every _____ hours 3. Encourage patient to cough and deep breathe every _____ hours while awake, 4. Administer oxygen via _____ at _____L/minute or _____%. 5. Suction patient as needed 6. Provide trach care every _____ hours." The care plan was incomplete and unclear. For example: It did not reflect the patient's ventilator status and associated management, the oxygen administration intervention was unclear in relation to the use of the ventilator. Further, the spaces for patient specific goal and intervention information were blank. It was unclear whether the plan of care had been coordinated with Respiratory Therapy in relation to the patient's respiratory needs.

* "Problem 4" was dated 10/27/2022 and was for "Alteration in Elimination - Bladder related to urinary retention, disease process as evidence by suprapubic pain, oliguria." "Goal" included "1. Patient will be continent of bladder utilizing ____ device(s)." "Interventions" included "1. Assess for signs or symptoms of bladder infection ... 2. Monitor fluid intake and output every ____ hours 3. Remove Foley catheter 4. Perform bladder ultrasound post void to determine residual until volumes are less then ____ cc." The care plan was incomplete and unclear. The spaces for patient specific goal and intervention information were blank. It was not clear how "post void ... "residual urine volume" was to be determined for this incontinent patient after the Foley catheter was removed. Further, the plan of care was dated 10/27/2022 however the bladder ultrasound was not ordered until 10/29/2022.

* "Problem 7" was dated 10/27/2022 and was for "Dysphagia-swallowing deficit related to aspiration as evidenced by dysphagia." The "Goal" was "will safely and effectively tolerate the least restrictive diet using compensatory swallowing strategies as needed without signs or symptoms of aspiration. See ST evaluation for details." There was one "Intervention" for "1. Teach education regarding dysphagia & aspiration." The problem statement was unclear. The goal statement contained the only reference on the plan of care to the patient's "diet" and it was not clear if foods and fluids were being provided by mouth on the date of this care plan and who was providing those. "See ST evaluation for details" was not appropriate as the plan of care should reflect clearly patient specific goals and interventions, coordinated with other disciplines, at the time the care plan is developed, and be updated as those change. Further, the only intervention was to "teach education" about dysphagia and aspiration. There were no interventions to prevent aspiration such as those reflected in the physician's orders and patient assessments on admission and throughout the hospital stay to include the patient's NPO status, HOB positioning, use of the TLSO brace, amount and type of assist with feeding as the by mouth diet progressed.

* "Problem 8" was dated 10/27/2022 and was for "Alteration in Skin integrity related to identified pressure injury, identified wound, post-surgical incision as evidenced by stage 2 or higher pressure injury, post surgical incision, unknown etiology wound to right heel." The "Interventions" included "1. Dressing change to wound(s) daily per physician order Discontinue: 10/27/2022 ... 2. Assess wound(s) and/or incision(s) every shift for signs or symptoms of infection Discontinue: 10/27/2022 ... 3. Keep wound(s), incision(s), and skin clean and dressings dry Discontinue: 10/27/2022 ... 4. Change patient position in bed every 2 hour(s) Discontinue: 10/27/2022 ... 5. Measure and Photograph each pressure ulcer / wound stage II or greater / unstageable and full thickness wounds on first dressing change and weekly Discontinue 10/27/2022 ... 6. Provide and monitor food and fluid intake Discontinue: 10/27/2022 ... 7. Prevent, assess, and treat wounds for signs or symptoms of infection per physician order Discontinue: 10/27/2022". The problem description was unclear and did not include patient specific identification of Patient 3's specific wound types and locations identified on admission and in the physician's orders for wound treatments. The patient's sacral wound, right foot and toe wound, occipital head wound, and coccyx wound were not identified on the care plan. Although a right heel wound was identified on the care plan on 10/27/2022 it was not identified on the admission assessment nor was there a treatment order for it until 12/08/2022. The "skinned knees" identified in the 12/28/2022 note above that resulted from a fall from bed was also not included. Seven of the eight interventions (excluding number "5") that had been "discontinued" on 10/27/2022 were then listed again, and number "4" had been modified to include "and keep bilateral heels floated." However, there was no date to indicate when the plan of care had been modified and those interventions added. Further, it was unclear what "Provide and monitor food and fluid intake" meant for this patient who was NPO on PEG tube feedings on the date of the care plan.

2.c. Patient 3's care plan failed to address the myriad of the patient's problems and needs on admission and during the hospital stay, including for example: Dependence for ADLs, mobility, positioning, pain, nutrition by PEG tube feedings and by mouth, aspiration precautions during tube feedings and for intake by mouth, care and management of multiple IV sites, use of a TLSO, MRSA infection, and contact isolation.

2.d. During interview with the CMD on 11/13/2024 beginning at 1045 they confirmed that Patient 3's care plan was not complete, including that it did not address the patient's pain problems and needs.

3.a. Review of Patient 5's medical record reflected they were admitted to the hospital on 12/16/2022, discharged on 01/17/2023, and had problems and needs that included, for example:
* A "Nursing Admission Assessment" that was signed by an RN on 12/16/2022 at 1916 included the following information:
- Regarding Patient 5's ADL, personal care, and mobility needs: "Eating ... Dependent ... Oral Hygiene ... Dependent ... Upper Body Dressing ... Dependent ... Sit to Lying ... Dependent ... Lying to sitting on side of bed ... Dependent ... Walk 10 Feet (once standing ...) Patient unable to walk 10 due to medical condition." All other ADLS were documented as "NOT ATTEMPTED due to medical condition/safety concerns."
- Regarding the patient's toileting and elimination needs: "Bladder History - [Both] Continent [and] Incontinent [were checked] - Bladder Continence: Not Applicable (e.g. Indwelling Catheter) ... Urinary device present: Yes ... External/condom catheter Date of Insertion: 12/16/2022 ... Bowel Continence: Frequently incontinent ... Toileting Hygiene (ability to adjust clothing before, clean after void/BM, and adjust clothing after) Dependent."
- Regarding the patient's skin/wound needs the assessment reflected: "Any wounds present? No ... Risk Level for skin Breakdown: Mild Pressure Injury Risk."
- Regarding the patient's fall risk the assessment reflected: "Morse Fall Scale Total Score: ... 60 ... High Risk; Action - Implement High Risk Fall Precautions."
- Regarding the patient's nutrition and fluid intake the assessment reflected: "Aspiration Precautions ... Dobhoff [feeding tube] ... Nutritional Approaches on Admission: Check all of the following nutritional approaches that apply on admission: ... Feeding-tube ... Nutrition Risk Factors - Enteral [feeding] ...
- Regarding the patient's respiratory condition and needs the assessment reflected: "Aspiration Precautions ... Upper respiratory infection. [Pneumonia] IV antibiotic ... Started 12/16/2022 ... Artificial Airway? Yes ... Oxygen Therapy ... Route: Ventilator ... Tracheostomy Tube Type: Cuffed ... Ventilator: Yes ... Head of Bed Elevated? Yes ... Daily Suction? Yes."
- Regarding IV access the assessment reflected that the patient had two sites: "Saline/Heplock #1 Right Wrist" and "Saline/Heplock #2 Left Antecubital."

* On 12/16/2022 at 1631 a physician's order was written for "Initial Ventilator Settings Once, FiO2%: 30, Tidal Volume (cc): 1, Request Type: Routine, PS: 10, PC: 0, PEEP: 5, Resp. Rate (bpm): 0, Mode: PSV."
* On 12/16/2022 at 1650, the physician signed a History & Physical that reflected the patient "Has been undergoing ventilator weaning protocol ... Primary Admission Criteria Vent Wean." The physician documented under "Impression/Plan: Acute Respiratory Failure: type 2 with Tracheostomy Dependency ... will continue to monitor with routine supportive care and plan for [Pulmonary and Critical Care Medicine] consultation for assistance with weaning."
* On 12/16/2022 at 1708 a physician's order was written for "HOB 30-45 degrees As Needed PRN, Request Type: Stat Indication: positioning."
* On 12/17/2022 at 1000 a physician's order was written for the IV antibiotic "ceftriaxone [Rocephin antibiotic] ... Infuse ... over 30 Minutes intravenously Daily ..."
* On 12/19/2022 at 1516 a SLP signed a "ST Dysphagia Evaluation" that reflected "SLP Recommendations" for "Aspiration Risk: Liquids Minimal Solids Moderate ... Check all of the following nutritional approaches that apply ... Feeding-tube ... Recommended Diet ... NPO ... Management ... Trial Feed with SLP Only ... Small Bites/Sips ..."
* On 12/19/2022 at 1601 the SLP signed a "Speaking Valve Evaluation" that reflected "Current ventilator support ... Type of Speaking Valve: Passy Muir ... Communicated to RT about cuff down and PMV removal ... SLP Speaking Valve Recommendations: ... Speaking Valve placement with nursing supervision."
* On 12/19/2022 at 1906 an RD signed a Registered Dietitian Progress Note that reflected "Weight: [136.2 lbs. on 12/16/2022] ... Diet: NPO Intake/Meal: ... TF: DHT ... Currently NPO and nutrition per PEG. Recommendations: 1. Provide nutrition per DHT. TF as ordered. Adjust as needed to support nutrition. 2. Advance to oral diet per SLP eval and MD order. If PO diet is appropriate, offer Carbohydrate Controlled Diet. 3. Monitor TF tolerance, weight, lab, bowel routine, hydration status and change in needs."
* On 12/19/2022 , three physician's orders were written that required treatments for "[Anterior] Neck [Deep Tissue Injury]," "Sacrum [Deep Tissue Injury]," and an unidentified "wound."
* On 12/26/2022 at 1508 an RD signed a "Registered Dietitian Progress Note" that reflected "Diet: NPO Intake/Meal: ... TF: DHT ... Patient complains of hunger ... Pt weight is down by [22.7 lbs.] ..."
* On 12/30/2022 at 1740 a RD signed a "Registered Dietitian Progress Note" that reflected "Diet: NPO except ice, 1:1 Assist (12/30), stop when cough ... TF: DHT ... Recommendations: 1. Provide nutrition per DHT Increase TF rate to 85 ml/h. TF as ordered. Adjust as needed to support nutrition. 2. Advance to oral diet per SLP eval and MD order. If PO diet is appropriate, offer Carbohydrate Controlled Diet. 3. Monitor TF tolerance, weight, lab, bowel routine, hydration status and change in needs."
* On 12/31/2022 at 1000 a physician's order was written for NPO EXCEPT ICE Daily, Request Type: Routine, Comments: NPO except ice chips. Provide 1:1 Assist. Stop when cough.
* On 01/05/2023 at 1400 a SLP signed a "ST Daily Session Note" that reflected "... Pt upgraded to PO snack, puree/thins. Continues with weak coughs."
* On 01/05/2023 at 1730 a physician's order was written for "PO Snack Diet Three Times Daily with Meals, Request Type: Routine, Texture: PUREED, Consistency: THIN LIQUID, Fluid Restriction: NONE, Comments: Provide 1:1 Feeding Assistance. Likes Yogurt"

3.b. Patient 5's "Plan of Care Complete Plan" was not clear and complete, not patient-specific, had not been updated throughout the patient's stay, and had not been coordinated with the other disciplines to ensure the provision of safe and appropriate care. For example:
* "Problem 1" was dated 12/16/2022 and was for "Alteration in Respiratory Function related to Pneumonia as evidenced by abnormal breath sounds, shallow respirations. The "Goals" included "1. Patient will maintain oxygenation at ____ %" was not complete. "Interventions" were "1. Assess/auscultate lung sounds every _____ hours. 2. Monitor respiratory rate, depth, and efforts every _____ hours. 3. Encourage patient to cough and deep breathe every _____ hours while awake. 4. Encourage patient to use incentive spirometer every ___ hours while awake. 5. Administer nebulizer treatments as ordered by physician. 6. Administer oxygen via _____ at _____L/minute or _____%. 7. Provide chest percussion every ____ hours while awake. 8. Suction patient as needed 9. Educate patient / caregiver regarding disease process, pulmonary condition, and pulmonary medications. 10. Provide trach care every _____ hours. 11. Teach patient pursed-lip breathing or diaphragmatic breathing techniques." The care plan was incomplete and unclear. For example: It did not reflect the patient's ventilator status and associated management, the oxygen administration intervention was unclear in relation to the use of the ventilator. There were no goals for resolution of the pneumonia, and no interventions related to the IV antibiotics the patient was being treated with. Further, the spaces for patient specific goal and intervention information were blank. It was unclear whether the plan of care had been coordinated with Respiratory Therapy in relation to the patient's respiratory needs.

* "Problem 2" was dated 12/16/2022 and was for "Invasive Lines (Central, PICC, peripheral lines)." It was not patient specific and did not identify the specific type of lines in use and where they were located. "Interventions" were incomplete, unclear and contradictory, for example five of the seven interventions were related to dressing changes and provided contradictory and unclear information: "2. Change dressing as per MD orders. 3. Change dressing every 7 days and as needed. 4. Change gauze dressing every 48 hours. 5. Change transparent dressing every 7 days ... 7. Dressing change to catheter site as ordered." In addition, there were no interventions related to other aspects of "Invasive Lines" management such as site changes and tubing changes, which would be different for each type of line used.

* "Problem 3" was dated 12/16/2022 and was for "Knowledge Deficit." The "Goal" was "1. Patient/caregiver to demonstrate knowledge in mobility techniques and home exercise program." The "Interventions" were "1. Medication/food drug interactions 2. Safety 3. Skin/Wound Care 4. Co-morbid disease processes." The problem statement was vague and non-specific, and the interventions were unrelated to the goal, vague, and not patient specific.

* "Problem 4" was dated 12/18/2022 and was for "Risk for Falls ..." A "Goal" was "1. [Patient] will remain free of falls during this hospitalization." The "Interventions" included "1. Maintain fall precautions. Fall mats at bedside. Place appropriate signage outside [patient's] room, ensure [patient] wears non-skid socks, utilize chair/bed alarms as needed ... 5. Assess toileting and hydration needs every 2 hours." The care plan goal was not met as the patient experienced falls during the hospitalization as indicated in the findings for Patient 5 under Tag A-145 and Tag A-395 that reflect care plan interventions had not been followed. Further, the care plan had not been updated and interventions evaluated after the actual falls occurred.

* "Problem 5" was dated 12/19/2022 and was for "Potential for Skin Breakdown related to incontinence, altered mobility, altered nutritional status." The "Goal" was "Skin to remain intact without evidence of breakdown ..." The "Interventions" included "1. Inspect skin every 12 hours ... 2. Change patient position in bed every 2 hours ... 4. Keep skin free of urine and/or feces with cleansing immediately after incontinence or soiling ... 5. Incontinence care to skin and apply moisture barriers." Care plan interventions for incontinent care had not been consistently carried out as indicated in the findings for Patient 5 under Tag A-395. Further, the patient's actual skin alterations identified on the patient's neck, sacrum, and on an unidentified location were not addressed.

3.c. Patient 5's care plan failed to address the myriad of the patient's problems and needs on admission and during the hospital stay, including for example: Dependence for ADLs, mobility, positioning, communication and use and management of a PMV, actual skin alterations/wounds, nutrition by tube feedings via either PEG or DHT (both identified by the RD on 12/19/2022), NPO status, aspiration risk and precautions, changes to food and fluid intake by mouth, and weight loss.

3.d. During interview with the CMD on 11/13/2024 beginning at 1415 they confirmed that Patient 5's care plan was not complete, including that it did not address the patient's nutritional needs and tube feedings, and HOB positioning.

4.a. Review of Patient 8's medical record reflected they were admitted to the hospital on 12/01/2023, discharged on 03/06/2024, and had problems and needs that included, for example:
* The "History and Physical" signed by an MD on 12/01/2023 at 1942 reflected the following information about the patient's problems and needs: "multitrauma from 11/3/23 motorcycle accident ... [Altered Mental Status] still, but understands questions, randomly moving [their] hands which will required [sic] restraint ... Medically Complex ... Respiratory Complex ... Infectious Disease ... Wound/Skin ... Acute Respiratory Failure ... Trach/ET tube ... Aspiration Pneumonia ... ORIF right distal arm FX Date: 11/08/2023 ... alert, anxious, understands questions, mild confusion ... facial lacerations ... right frontal laceration sutured above the eyebrow ... trach in place ... rhonchi and crackles bilaterally ... PEGT in place ... right forearm casted (due to ORIF for fx) ... PICC [left upper extremity] ... agitation, dysphagia, Keppra [antibiotic for seven] days ... see [neurosurgery] in 2 [weeks] ... [Right] medical [sic] and lateral anterior max sinus wall fx, orbital floor fx, [Right] periorbital hematoma and laceration ... see plastic surgeon in 2 [weeks] ... T5 and 7 wedge [compression fracture] TLSO [thoracic lumbar sacral orthosis brace] when up - PT/OT ... ORIF thumb 1st [metacarpal] fx/dislocation - splint, WBAT [Right upper extremity] ... [Left] cephalic [superficial vein thrombosis] on [ultrasound], Lovenox [blood thinner] 30 mg [twice a day] ... multimodal pain regimen ordered ... "
* The "Nursing Admission Assessment" for Patient 8 was signed by one RN on 12/01/2023 at 2032 and a second RN on 12/02/2023 at 0404. The assessment for this patient with numerous complexities and needs was largely incomplete and it was unclear what aspects of the "assessment" had been documented by each of the RNs. The minimal assessment information that had been documented included: "Unsafe behavior observed. Inconsistently follows safety recommendations and directions ... Morse Fall Scale Total Score: 30 ... Moderate Risk - Implement Universal Fall Precautions ... PICC Line #1 Left Cephalic ... Bladder History ... Incontinence ... Urinary Device present? Yes ... External/condom catheter ... Inattention ... Behavior present, fluctuates ..

ADMINISTRATION OF DRUGS

Tag No.: A0405

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Based on observation, interviews, review of medical record documentation for 6 of 6 patients who were reviewed for medication administration (Patients 2, 3, 8, 9, 18, and 23), and review of P&Ps it was determined the hospital failed to ensure that medications were administered to the hospital's medically complex and vulnerable patients in accordance with clear physician's orders and hospital P&Ps, including those medications ordered as PRN. Failures included:
* Physician's orders for medication were not clear, including the route of administration, and the RN failed to contact the physician to clarify and confirm the orders.
* Ordered doses of medications were not given.
* PRN administration indicators were not clear, objective, and patient-specific, and the RN failed to contact the physician to clarify and confirm the orders.
* PRN medications were given that were not in conformance with PRN administration indicators.
* The patient's response and the effectiveness of medications were not documented.
* Medications that were not dispensed from the hospital's pharmacy were stored in a patient's room and administered by staff.

Findings include:

1.a. For Patient 2, review of the physician orders revealed the following orders for the anti-fungal nystatin to treat the patient's oral thrush:
* On 02/09/2022 order #8 was written by a PA to start at 2100 for "nystatin ... Give [500,000] unit (5 mL) per tube Four Times Daily." The order was written for 10 days with an end on 02/19/2022 at 1700.
* On 02/10/2022 order #40 was written by the PA to start at 1700 for "nystatin ... Give [500,000] unit (5 mL) per tube Four Times Daily." The order was written for 10 days but was discontinued earlier on 02/18/2022 at 1410.

1.b. The current Drugs.com website reflects that the recommendation for the "Usual Adult Dose for Oral Thrush" is "400,000 to 600,000 units of the oral suspension orally 4 times a day. Duration of therapy: At least 48 hours after symptoms have disappeared and cultures demonstrate eradication." Instructions for use included: "Measure liquid doses carefully ... Swish it in your mouth as long as you can before swallowing." The daily total of 400,000 to 600,000 units four times a day was 1,600,000 to 2,400,000 units in a day. However, as the two orders were written the patient would be receiving 1,000,000 units four times a day for a total daily amount of 4,000,000 units.

1.c. Review of the MAR for Patient 2 revealed order #8 and order #40 were printed on the MAR one above the other. As written in the orders and on the MAR the patient was to receive eight doses per day, two doses at each of the four times ordered per day. The MAR reflected that doses given ranged from one dose per day on 02/13/2022 up to eight doses per day such as on 02/14/2022. That equated to amounts above the maximum daily recommendation of 600,000 units four times daily, or 2,400,000 units in one day, on seven of the 11 days of the treatment, with amounts up to 4,000,000 units. Additionally, numerous doses were not given for one or both of those orders during the course of treatment and there were no documented explanations:
* On 02/09/2022 one dose given at 2100.
* On 02/10/2022 one dose given at 0800, one dose given at 1200, two doses given at 1700, two doses given at 2100. That was six doses given during the day for a total amount given of 30 mLs or 3,000,000 units.
* On 02/11/2022 one dose given at 0800, one dose given at 1200, one dose given at 1700, two doses given at 2100. Five doses given during the day for a total amount given of 25 mLs or 2,500,000 units.
* On 02/12/2022 two doses given at 0800, two doses given at 1200, one dose given at 1700, no doses given at 2100. Five doses given during the day.
* On 02/13/2022 no doses given at 0800, one dose given at 1200, no doses given at 1700, no doses given at 2100. One dose given during the day.
* On 02/14/2022 two doses given at 0800, two doses given at 1200, two doses given at 1700, two doses given at 2100. Eight doses given for a total amount given of 40 mLs or 4,000,000 units.
* On 02/15/2022 no doses given at 0800, two doses given at 1200, two doses given at 1700, two doses given at 2100. Seven doses given for total amount given of 35 mLs or 3,500,000 units.
* On 02/16/2022 two doses given at 0800, two doses given at 1200, two doses given at 1700, two doses given at 2100. Eight doses given.
* On 02/17/2022 two doses given at 0800, two doses given at 1200, no doses given at 1700, one dose given at 2100. Four doses given for total amount given of 20 mLs or 2,000,000 units.
* On 02/18/2022 one dose given at 0800, two doses given at 1200, and order #40 was discontinued at 1410, so only one dose given at 1700, and one dose given at 2100. Five doses given.
* On 02/19/2022 one dose given at 0800, one dose given at 1200, and no dose given at 1700 which was when the last dose of the 10 day order #8 was to be given. Two doses given.

1.d. There was no indication that the RN questioned why there were two orders for the same amount and frequency of nystatin simultaneously, or that the RN had contacted the LIP and the pharmacist to clarify whether the two simultaneous orders were intentional. There was no indication that the RN ensured the patient was monitored for potential side effects due to the increased dosage ordered. There was no indication of follow-up or investigation to confirm the extent of the possible medication errors that had occurred for the 40 administration opportunities. On seven occasions the patient received no dose, on 14 occasions the patient received one dose, and on 19 occasions the patient received two doses. The only nursing note that referenced nystatin administration was signed by an RN on 02/13/2022 at 0514 and reflected "Realized that scheduled Nystatin was in the medication room, did give it to patient. Although charted it as not given because I couldn't find it. Wasn't sure how to fix that in the charting."

1.e. Review of the medical record for Patient 2 revealed the following documentation written after the 02/2022 course of nystatin had been completed:
* On 02/28/2022 at 1843 an RN note reflected "Called doctor to order medicines for oral thrush, they said they were going to order nystatin." There was no documentation of RN assessment of the patient's oral condition at that time and what caused them to contact the physician "to order medicines for oral thrush." There were no physician orders documented until 03/02/2022.
* On 03/02/2022 order #71 was written by the PA to start at 1700 for "nystatin ... Give [500,000] unit (5 mL) by mouth Four Times Daily." The order was written for 10 days with an end on 03/12/2022 at 1200.
* On 03/03/2022 at 1722 an LIP note reflected the "Assessment/Plan" included "Thrush - Nystatin x 14 days." However, the LIP orders written on 03/02/2022 were for 10 days of Nystatin.
* On 03/04/2022 at 1426 an RN note reflected a conference with the spouse had been conducted on 03/03/2022. The note reflected the spouse had "concerns [revolving] around nursing care, including oral care ..." There was no RN assessment of the patient's oral care problems and needs at that time.
* On 03/05/2022 at 0109 an RN note reflected "Oral mucosa looking cleaner, moister and less thrush bits." That was the only nursing documentation in the record that described the patient's oral condition. There was no RN assessment prior to initiation of the nystatin orders and no assessment after the completion of the full course of nystatin.
* On 03/11/2022 at 1507 an LIP note reflected their "Assessment/Plan" included "Thrush - Nystatin x 14 days."

1.f. Review of the MAR for Patient 2 revealed that order #71 for nystatin was not followed:
On 03/03/2022 at 1700 the MAR contained a "[not given]" entry however there was no reason or exploitation for the missed dose and medication error.
On 03/05/2022 at 1700 the MAR contained no entry, nor was a reason or explanation for the missed dose and medication error documented.

2.a. For Patient 3, review of the MARs reflected there was no documentation for the reasons that regularly scheduled pain medications were not given. For example there was no MAR documentation for the following:
* On 10/26/2022 a physician's order was written for "Lidocaine 5% ... Apply 1 ... patch topically At bedtime indication: apply to left side of incision site." The MAR reflected it was not given on 11/09/2022 through 11/14/2022, 11/16/2022 through 11/25/2022, and 11/27/2022.
* On 10/26/2022 a physician's order was written for "Lidocaine 5% ... Apply 1 ... patch topically At bedtime indication: apply to right side of incision site." The MAR reflected it was not given as ordered on 11/09/2022 through 11/14/2022, 11/16/2022 through 11/25/2022, and 11/27/2022.
* On 10/26/2022 a physician's order was written for "Gabapentin ... 300 mg (1 capsule(s)) per tube Every Eight Hours." The MAR reflected it was not given on 11/11/2022 at 0600.
* On 12/08/2022 a physician's order was written for "Gabapentin ... 300 mg (1 capsule(s)) by mouth Every Eight Hours." The MAR reflected it was not given on 12/14/2022 at 1400 and on 12/21/2022 at 0600.
* On 01/17/2023 a physician's order was written for "Gabapentin ... 300 mg (1 capsule(s)) by mouth Three Times Daily." The MAR reflected it was not given on 01/21/2023 at 0600.

2.b. Review of the MARs for Patient 3 reflected there was no documentation of the patient-specific reasons for the administration of each PRN pain medication given (pain score, fever) and the responses to the medications. There was no MAR documentation that the medications were given in accordance with the pain scores nor documentation of the patient's responses to those doses. For example:
* On 10/26/2022 a physician's order was written for "oxyCODONE HCL ... 10 mg (1 tablet(s)) per tube Every Four Hours PRN Indication: severe pain: score 7-10." The MAR reflected it was given on 11/01/2022 x2, 11/03/2022, 11/05/2022 x2, and 11/06/2022.
* On 10/26/2022 a physician's order was written for "oxyCODONE HCL ... 5 mg (1 tablet(s)) per tube Every Four Hours PRN Indication: MODERATE PAIN: score 4-6." The order was renewed on 11/09/2022. The MAR reflected it was given on 11/06/2022, 11/09/2022, 11/11/2022, 11/16/2022, 11/17/2022, and 11/20/2022.
* On 12/08/2022 a physician's order was written for "oxyCODONE HCL ... 5 mg (1 tablet(s)) by mouth Every Four Hours PRN Indication: MODERATE PAIN: score 4-6." The MAR reflected it was given on 12/13/2022, 12/15/2022 x2, 12/21/2022, and 12/26/2022.
* On 11/07/2022 a physician's order was written for "Acetaminophen ... 500 MG ... (1 tablet(s)) per tube Every Six Hours PRN ... Indication: fever or mild pain (score: 1-3)." The MAR reflected it was given 31 times from 11/07/2022 through 12/07/2022.
* On 12/08/2022 a physician's order was written for "Acetaminophen ... 500 MG ... (1 tablet(s)) by mouth Every Six Hours PRN ... Indication: fever or mild pain (score: 1-3)." The MAR reflected it was given 45 times from 12/08/2022 through 01/27/2022.

2.c. For Patient 3 refer to Tag A-395 that reflected physician orders for application of topical medication for wound care were not clear and were not followed, and that nursing staff administered topical medications to wounds that were not ordered.

2.d. During interview with the CMD at the time of the record review for Patient 3 on 11/13/2024 beginning at 1045 they confirmed that the patient's pain was not assessed and a plan of care was not developed to address that problem/need. They further stated they were unaware of any medication administration documentation that identified the reasons medications were not administered as ordered, and the reasons that PRN medications were administered and the patient's responses to those. In an email from the CMD received on 02/28/2025 at 1008 they confirmed that all medication administration documentation was provided.

3.a. For Patient 8 there was no documentation of RN assessment of the 12 routinely scheduled and PRN medications the patient was taking that had potential side effects that included sedation or drowsiness, and some of which additionally had potential behavioral side effects. There was no documentation the RN questioned the medication regimen and contacted the physician and pharmacist to confirm and clarify the orders. PRN orders did not include clear, objective, and patient-specific indicators for administration and there was no documentation to reflect the patient's responses to PRN medications given. For example:

3.b. The physician's orders and the 12/2023, 01/2024, and 02/2024 MARs for Patient 8 reflected the patient's medication regimen included 12 routinely scheduled and PRN medications that had potential side effects that included sedation or drowsiness, and some of which additionally had potential behavioral side effects. The PRN medications are listed under Finding 3.c. below and the routinely scheduled drugs were as follows:
* The anti-parkinsonian drug benztropine mesylate given routinely two times daily throughout the hospitalization. (Side effects also included confusion, disorientation, nervousness, visual hallucinations worsening of psychotic symptoms, toxic psychosis, aggressive and violent behavior.)
* The blood pressure drug labetalol given routinely two times daily throughout the hospitalization.
* The muscle relaxant drug baclofen given three times daily beginning on 12/20/2023 at 1400 through 12/25/2023 at 0600.
* The antipsychotic drug quetiapine fumarate (Seroquel) given routinely once daily on 12/01/2023 and 12/02/2023, twice daily from 12/02/2023 through 12/22/2023, and three times daily from 02/11/2024 through 02/29/2024.
* The antipsychotic drug olanzapine (Zyprexa) given routinely two times daily beginning 12/08/2023 throughout the hospitalization. (Side effects also included restlessness, back pain, and attention disturbance.)
* The antidepressant drug bupropion HCL given twice daily routinely beginning on 02/10/2024 at 2200 with the last dose administered on 03/05/3034 at 2230. (Side effects also included symptoms of anxiety, agitation, concentration difficulty, and nervousness.)

3.c. Physician's orders for Patient 8 reflected that patient-specific indicators for PRN medication administration were not always included in PRN physician's orders. The MARs lacked documentation to reflect that patient-specific indicators were met for each PRN medication administered. In addition, the patient's responses to PRN medications given were not evident. PRN drugs for Patient 8 were administered as follows:
* Antipsychotic drug olanzapine (Zyprexa) was ordered PRN for "agitation" and was given 17 times from 12/01/2023 through 12/08/2023. The order did not describe what behaviors would demonstrate "agitation" for Patient 8.
* Antianxiety and sedative drug diazepam (Valium) was ordered PRN for "severe agitation" and was given 39 times from 12/14/2023 through 01/05/2024. The order did not describe what behaviors would demonstrate "severe agitation" for Patient 8.
* Antihistamine drug diphenhydramine (Benadryl) was ordered PRN for "itching" and was given five times from 12/11/2023 through 12/23/2023.
* Antianxiety drug lorazepam (Ativan) was ordered PRN IV for "severe agitation," (with additional potential side effects of behavioral disorders), was given 20 times from 12/02/2023 through 12/14/2023. The order did not describe what behaviors would demonstrate "severe agitation" for Patient 8.
* Antianxiety drug lorazepam (Ativan) was ordered PRN by mouth for "anxiety" and was given 20 times from 01/09/2024 through 01/31/2024 and 31 times from 02/01/2024 through 02/29/2024. The order did not describe what behaviors would demonstrate "anxiety" for Patient 8.
* Narcotic pain drug hydromorphone HCL (Dilaudid) 1 mg IV PRN ordered for pain level of 10 on pain scale of 1 - 10 was given 20 times from 12/01/2023 through 12/04/2023.
* Narcotic pain drug hydromorphone HCL (Dilaudid) 1 mg IV PRN ordered for pain levels of 9-10 was given 56 times from 12/05/2023 through 12/21/2023, and .5 mg IV PRN for pain levels 9-10 was given six times from 12/21/2023 through 12/26/2023 and five times from 01/01/2024 through 01/04/2024.
* Narcotic pain drug oxycodone PRN ordered for pain levels 6-7 was given three times from 12/02/2023 through 12/05/2023. Ordered for pain levels 6-8 it was given 17 times from 12/05/2023 through 12/19/2023 and given 12 times from 12/23/2023 through 01/02/2024. Ordered for pain levels 4-5 was given four times between 12/10/2023 through 12/26/2023.

3.d. For Patient 8 there were no physician orders to "sedate" the patient and no indication in physician notes that sedating the patient was part of the physician's plan. The notes that follow reflect that the patient did experience sedation, was unable to participate in therapy as result, and that the physician attempted medication changes because the patient was sedated. The RN failed to assess the patient's response to the medication regimen and there was no indication the RN contacted the physician and pharmacist in response to the sedation recurrences during the hospitalization:
* On 12/15/2023 at 1904 an RN signed a note that reflected "gave family member education on pt aggressive behavior from TBI to frontal lobe and current treatment plan to keep pt calm and safe with sitter, restraints, and sedation as needed." It was unclear what the RN meant by "to keep pt calm ... and sedation as needed," if chemical restraint was the intention of the RN, and what written "treatment plan" they referred to.
* On 12/21/2023 at 0957 a PTA signed a note that reflected "Pt with sitter stating pt was sedated this AM and pt was beginning to wake up."
* On 12/25/2023 at 0957 an MD signed a note that reflected a medication change from Zyprexa 10 mg twice a day to "... Zyprexa changed to 5mg Qam and 10mg hs, off baclofen due to sedation."
* On 12/26/2023 at 1548 a PT signed a that reflected "Patient unable to participate in therapy today due to RN hold due to significant restlessness/ agitation or patient being too sedated to participate."
* On 12/28/2023 at 1447 a PTA signed a note that reflected "Pt not appropriate for therapy. Pt is Rancho I [Rancho Scale 1 = no response] and not waking d/t heavy sedation throughout the day."
* On 01/02/2024 at 1559 an SLP wrote "still variable w/ alertness, falls asleep while chewing at times."
* On 01/04/2024 at 0859 an SLP note reflected "Pt is positioned upright in bed, has fallen asleep ... no increase in texture until more consistently alert as pt is falling asleep w/ food in mouth."
* On 01/09/2024 at 1440 an SLP wrote "... per report still falling asleep frequently ... pt is falling asleep w/ food in mouth."

3.e. During interview with the CMD at the time of the record review for Patient 8 on 11/14/2024 beginning at ~ 1145 they confirmed that the patient exhibited "violent, resistive, and combative" behaviors. They stated they were unaware of any medication administration documentation that identified the reasons medications were not administered as ordered, and the reasons that PRN medications were administered and the patient's responses to those. In an email from the CMD received on 02/28/2025 at 1003 they confirmed that all medication administration documentation was provided.

4.a. For Patient 9 there was no documentation of RN assessment of the 10 routinely scheduled and PRN medications the patient was taking that had potential side effects that included sedation or drowsiness, which the patient experienced during the hospitalization. In addition, medications were ordered and administered "by mouth" when the patient was "NPO," medications were not administered as ordered, and the patient-specific reasons for administration of PRN medication were not clearly documented in the physician's orders nor documented prior to each administration along with the patient's response to the medication. For example:

4.b. The physician's orders and the MAR for Patient 9 reflected the patient's medication regimen included 12 routinely scheduled and PRN medications, including those for pain and anxiety, that had potential sedation or drowsiness side effects, and some of which had potential anxiety side effects. There was no documentation to reflect the RN assessed the patient's medication regimen, in coordination with the pharmacy, to ensure the patient did not experience those effects. The medications were as follows:
* Anticonvulsant and nerve pain drug gabapentin given once daily.
* Anticonvulsant drug divalproex sodium (Depakote) given once daily.
* Antihypertensive cardedilol.
* Antiemetic metoclopramide given three times daily.
* Antidepressant sertraline HCL (Zoloft) given once daily.
* Narcotic opiod pain drug morphine sulfate given one time on 01/29/2024.
* Antianxiety drug lorazepam (Ativan) PRN for "anxiety." Given 17 times between 01/23/2024 and 01/30/2024.
* Antiemetic drug ondansetron (Zofran) PRN for "nausea and vomiting." Given six times between 01/24/2024 and 01/27/2024.
* Antihistamine drug diphenhyrdramine (Benadryl) PRN for "itching, nausea, anxiety." Given five times between 01/24/2024 and 01/27/2027.
* Narcotic opiod pain drug Fentanyl PRN for pain levels of 6-7 on pain scale of 1-10, pain levels 8-10, and pain levels 9-10. Given nine times between 01/23/2024 and 01/31/2024.
* Narcotic opiod pain drug hydrocodone/acetaminophen (Norco) PRN for pain levels of 6-8. Given four times on 01/26/2024 and 01/27/2024.
* Antipsychotic drug olanzapine (Zyprexa) PRN for "agitation." Ordered two days prior to discharge and not documented as given.

4.c. Nursing notes for Patient 9 reflected that the patient experienced episodes of sedation. Medication administration was not based on RN assessment of the patient's response to the medication regimen and there was no indication the RN contacted the physician and pharmacist in response to the administration of multiple psychotropic and narcotic medications administered and the sedation recurrences during the hospitalization:
* On 01/25/2024 at 1206 a PT signed a "PT Initial Evaluation" that included a note that "patient's [family] reports patient is much more lethargic and confused than normal; reported to RN who reports patient got ativan this morning due to agitation."
* On 01/25/2024 at 1841 an LPN signed a note that reflected "High anxiety at very beginning of shift, controlled with PRN Ativan. [Family] expressed concern of the over-effectiveness of this medication as [the patient] was not able to be wakeful for therapy sessions." There was no documentation to reflect what
behaviors the patient exhibited that demonstrated "High anxiety" and none that reflected that the concerns about possible over-sedation had been assessed by the RN and reported.
* On 01/26/2024 at 1754 an LPN note reflected "PRN zofran given x1 as of this note. PRN fentanyl, ativan given x2, norco x1, benadryl x1 as of this note. Pt is in and out of sleep all shift." However, the note was not consistent with the 01/2024 MAR that reflected that at the time "of this note" signed at 1754 the patient had been given the following medications, including seven PRN, that had side effects of sedation or drowsiness:
- The MAR reflected that Ativan PRN and Fentanyl PRN and Benadryl PRN were all given at 0825; gabapentin and Zoloft both given at 1000; Ativan PRN and Fentanyl PRN both given at 1236; metoclopramide given at 1400, Zofran PRN and Norco PRN both given at 1433.
- The MAR "Administration History" records reflected that the reasons both doses of Ativan were given were not documented; the reason the Benadryl was given was not documented; the reason the 1236 dose of Fentanyl was given was not documented; and an "Administration History" record for Norco was not provided to the surveyor.
- There was no RN assessment of the administration of three routinely scheduled, and seven PRN medications (for which reasons for administration were not clear), that had side effects of sedation or drowsiness, within an approximately six hour time frame between 0825 and 1433.

4.d. For Patient 9 who had a feeding tube, medication and supplements were ordered and administered "by mouth" although physician orders were in place for "NPO." Additionally, those were not given as ordered. For example:
* On 01/23/2024 at 1610 a physician's order was signed for "NPO DIET Every Shift ... Stat ..."
* On 01/23/2024 at 2200 a physician's order was signed for the anti-convulsant "Divalproex Sodium Sprinkle Cap DR (Depakote Sprinkle Cap) 125 MG, Give 250 mg (2 capsule(s)) by mouth At Bedtime." It was unclear why this medication was ordered "by mouth" for this patient who was NPO and received food/nutrition through a feeding tube. The order was in effect throughout the patient's stay until 01/31/2024 at 1120. The MAR reflected it was to be given at 2200 every night. The MAR "Administration History" record reflected it was not given on 01/26/2024. On 01/27/2024 it was given at 0054. This order created an additional risk for harm to this patient who was already at risk for aspiration.
* On 01/23/2024 at 2200 a physician's order was signed for the anti-diarrheal "Banana Flakes ... Give 1 packet(s) by mouth Every Eight Hours - Mix 1 packet with 120 mL warm water, stir until dissolved. - Feed via syringe into the feeding tube. - Flush w/ 30 mL water before and after." It was unclear why this supplement was ordered to be administered by two routes, one "by mouth" and one "by syringe into feeding tube," for this patient who was NPO and received food/nutrition through a feeding tube. The order was in effect throughout the patient's stay until 01/31/2024 at 1120. The patient's January 2024 MAR reflected the patient was administered the supplement that was ordered both "by mouth" and "via syringe" on 19 of 23 possible occasions from 01/23/2024 at 2200 through 01/31/2024 at 0600. However, it was not clear which route was used for administration. On four occasions it was documented as "[Not given]" however, there was no documentation to reflect why. This order created additional risk for harm to this patient who was already at risk for aspiration.
* On 01/25/2024 at 1000 another physician's order was signed for "NPO EXCEPT ICE Daily."

4.e. The MAR reflected a physician's order effective 01/23/2023 at 1610 for Lorazepam/Ativan "IV push every four hours PRN Indication: anxiety." The order did not specify the "anxiety" behaviors to be observed prior to administration.
* The MAR reflected the Ativan was administered on 17 occasions between 01/23/2024 at 1813 and 01/30/2024 at 0036. On none of those occasions did the MAR reflect what led to the administration of the PRN Ativan. For instance, what behaviors the patient exhibited that demonstrated the need for the medication, or whether the patient had requested it and why.
* On those occasions there was no documentation to reflect that alternative techniques to reduce anxiety had been attempted before the Ativan was administered.

4.f. On 01/24/2024 a physician's order was written for: "Metoclopramide HCL (Metoclopramide HCL) 10 MG/10ML, Give 10 mg (10 mL) per tube Three Times Daily." The MAR reflected it was to be given at 0600, 1400, and 2200. The MAR "Administration History" reflected it was not given at those times on 01/26/2024, 01/27/2024, and 01/28/2024. On 01/26/2024 it was not given at 2200. On 01/27/2024 it was given at 0020 and not given at 2200. On 01/28/2024 it was given at 0044.

4.g. Patient 9's MAR included a physician's order effective 01/26/2024 at 1026 for Fentanyl Citrate 25 mcg "IV push every four hours PRN Indication: Pain level (9-10) out of 10." The MAR reflected the Fentanyl IV was administered on five occasions beginning on 01/26/2024 at 1236. On four of the five occasions the Fentanyl was not administered in accordance with the ordered pain scale:
* On 01/27/2024 at 1114 it was given for a "Pain Scale: 6" and the location of pain was not specified.
* On 01/27/2024 at 2028 it was given for a "Pain Scale: 6" for "back" pain.
* On 01/28/2024 at 0245 it was given for a "Pain Scale: 7" for "back" pain.
* On 01/31/2024 at 0511 it was given for a "Pain Scale: 8" and location of pain was not specified.
* Further, there was no documentation to reflect that, in accordance with the plan of care for Patient 9 referenced under Tag A-396, alternative techniques to reduce pain had been attempted before the PRN Fentanyl was administered. Those included "positioning, modalities, distraction, and music/relaxation therapy."

4.h. During interview with the CMD at the time of the record review for Patient 9 on 11/14/2024 beginning at 1015 they confirmed that the patient received multiple medications with sedative effects. They further stated they were unaware of any medication administration documentation that identified the reasons medications were not administered as ordered, and the reasons that PRN medications were administered and the patient's responses to those. However, in an email received from the CMD on 11/20/2024 at 1144 they provided 12 "Administration History" documents for some of the patient's ordered medications. The documentation from those records is reflected in the findings for Patient 9 above.

4.i. For Patient 9, in an email received from the CMD on 11/20/2024 at 1143 they stated "After reviewing everything I do not think we gave the patient too many PRN medications to sedate [Patient 9]. I think it was a combination of PRN and scheduled meds that [the patient] was unused to taking as well as [their] medical conditions ... The DC summary [from hospital patient transferred from to Vibra] shows [patient] was put on [medication] there for concerns for seizures. It also notes metabolic encephalopathy and concern for anoxic brain injury. Both of those can see [sic] like the patient is confused/sedated. I don't know what education was provided to the family about [their] medical/cognitive condition and the new medications [they were] taking and their side effects. Adding in the [medication] for itching and the anti-emetic medications and it is not surprising if [patient] was sleeping quite a bit."

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5.a. Wound care was not provided to Patient 18 in accordance with hospital P&Ps or physician's orders. For example:
* A P&P titled, "Patient's Own Medications" with a review date of "12/23" was reviewed and reflected:
* "All medication administered to Vibra Healthcare, LLC ("Vibra") patients are provided by Vibra pharmacies. A patient's home medications may not be routinely administered while the patient is an inpatient at Vibra, unless the medication qualifies for an exception under this or other Vibra policies."
* "The patient's physician must write an order for the medication, noting that the patient's own medication may be used ..."
* " The pharmacist will identify, label (including patient name and dosing information) and store the medication in the pharmacy for administration in accordance with Vibra's medication administration
policies."
* "No medications, including patients' own medications or medications provided by Vibra, may be routinely stored at the bedside. Exceptions are made for "self-administered" medications prescribed by the physician ...".

5.b. During a tour of the high-acuity unit on 11/13/2024 with the RTM at 1420, physician wound care orders were not followed for Patient 18, and the following was observed:
* Patient 18 received personal care that had soiled the dressing on the patient's coccyx wound in the process.
* The RN assigned to Patient 18, entered the room with gloves. Hand hygiene was not observed.
* The RN exited the room, with gloves still applied, retrieved wound care supplies, and returned to Patient 18's room. Neither hand hygiene nor glove change was observed.
* After removing the soiled dressing, the RN cleaned the wound with normal saline, and patted the wound dry with a 4x4 gauze pad.
* The RN reached into an unlocked drawer at the patient's bedside closet. The drawer contained several medications from another facility, and without changing gloves or performing hand hygiene, the RN retrieved a tube of medication.
* The CNA who had performed personal care informed the RN that the medication they were about to apply was from another facility.
* The RN applied "Miconazole 2% ointment" to Patient 18's wound. The medication label had the name of another facility and was not labeled in accordance with the hospital's P&P for patient's own medication.
* The RN removed their gloves and performed hand hygiene.

5.c. The Plan of Care for Patient 18 had not b

FORM AND RETENTION OF RECORDS

Tag No.: A0438

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Based on interviews and review of medical record documentation for 16 of 23 patients whose records were reviewed for aspects of care and services (Patients 1, 2, 3, 4, 5, 6, 8, 9, 13, 15, 16, 17, 18, 21, 22, and 23) it was determined the hospital failed to ensure that medical record documentation was clear, complete, and accurately described all aspects of the patient's hospital stay, was promptly completed, and that the authors of all entries accurately authenticated, dated, and timed their entries to protect the integrity of the medical records for the hospital's medically complex and vulnerable patients. Failures included for example:
* Medical record entries were unclear and incomplete. Those included patient assessment forms and notes by nursing, pharmacy, dietary, rehabilitation, and respiratory staff; progress notes by all disciplines; MARs; physician's orders; care plans, and IDT Conference documentation.
* Entries on "Restraint Order and Flow Record" forms were dated and timed prior to the date and time the services recorded on the form were provided.
* Entries in the records were electronically signed, dated, and timed days to months after the original service date.
* Entries in the records were not properly authenticated by the authors of the entries. Those included flowsheet and MAR entries that lacked author authentication; entries on flowsheets and in progress notes that were authenticated with an incomplete name such as the first name only; entries that were authenticated without the credential of the author; and entries authenticated by an individual who used the credential of "RRT" who was not a licensed RRT.
* Entries on assessment forms for restraints and wounds that required "RN" assessment were completed, authenticated, dated, and timed by LPNs.
* IDT members' electronic signatures, dates, and times entered on the IDT Conference form did not align with the date of the IDT conference and with the list of attendees.
* An EEG test and interpretation conducted was not found in the medical record.
* Entries on tracheostomy care records reflected that trach care was repeatedly documented as having been conducted when the patient no longer had a trach.

Findings include:

1. For Patient 1 refer to the findings under Tag A-145 that reflected the medical record did not contain clear and complete documentation to describe the communications and sequence of events related to the patient's complaints of abuse. Further, documentation on HS reports regarding the patient's condition, status, and communications, was not recorded in the medical record.

2.a. In Patient 2's medical record, on 03/04/2022 at 0709 an LPN Wound Care note reflected that seven days earlier on "02/25/2022 1030 ... Left knee, there appears to be a potential abrasion to knee from other leg and devices against it. Cleansed with saline, patted dry. Applied adaptic dressing, covered and secured." Although the record reflected the wound was identified originally on 02/24/2022 there was no assessment documented at that time, no investigation as to how it was allowed to occur, nor were there orders for treatment until 03/04/2022. Further, it was not clear what the status of the dressing the LPN had covered the wound with seven days earlier on 02/25/2022 was, and what the condition of the wound was at the time the LPN wrote this note on 03/04/2022.

2.b. The medical record for Patient 2 reflected that an EEG was conducted, however, there were no physician's orders for an EEG and there was no EEG report found in the record. The documentation related to that testing was unclear and incomplete. For example:
* On 03/03/2022 at 1722 an LIP note reflected "EEG done - read pending."
* On 03/04/2022 at 0928 an LIP note reflected "The most recent imaging including CT head, EEG, and MRI of brain and spine were reviewed ... [perform] EEG if exam fluctuation noted ... 3/3 - ... EEG read not back pending. Initial read no seizures."
* On 03/04/2022 at 1415 an RN note for an IDT conference conducted on 03/01/2022 reflected "Patient is a slow trach wean. Although patient has preferential eye closure with [their spouse] and hearing aids in - allowing [them] to follow commands on [their] right side - [their] mentation does not support decannulation. [The patient's] slight decrease in alertness causes [them] to have difficulty in following commands and therefore prevents [them] from participating in therapy. An EEG was ordered due to wax/wane for follow-up on Keppra [anti-epileptic drug]." However, there was no documentation of an order for an EEG in Patient 2's medical record. Nor was there documentation of an EEG procedure or an interpretation of an EEG procedure.
* On 03/04/2022 at 1549 an LIP note reflected "EEG done - read pending."
* On 03/08/2022 at 0947 an LIP note reflected "The most recent imaging including CT head, EEG, and MRI of brain and spine were reviewed ... [perform] EEG if exam fluctuation noted ... 3/3 - ... EEG read not back pending. Initial read no seizures. 3/7 DC keppra as EEG was unchanged ... [Another physician] suggest ambien may wake [patient] up based on EEG findings." That same note was repeated in physician notes written on 03/10/2022, 03/11/2022, and 03/30/2022. Although the notes said the EEG and other diagnostic tests were "reviewed" there was no indication in those notes what the results of those tests were, including the EEG. Further, it was not clear what "EEG if exam fluctuation noted" meant, particularly as there was no baseline test or results found in the record. It was not clear what "EEG read not back pending" followed by "Initial read no seizures" meant. References to "EEG was unchanged" and "based on EEG findings" were not clear as there were no EEG readings, results or findings in the record.
* During interview with the CMD at the time of the record review for Patient 2 on 11/12/2024 beginning at 1230 they confirmed that an EEG test and interpretation could not be found in the medical record.

3.a. For Patient 3 IDT Conference documentation was unclear and incomplete. For example:
* IDT Conference notes reflected "Date of Team Conference" was 01/11/2023. That was the first IDT conference documented for Patient 3 who had been admitted on 10/27/2022. Although the "Attendees" list for the conference included the name of a nursing staff member who was not identified with their credentials, the form was signed by another person, an LPN, on 01/09/2023, two days before the conference. In addition, the entire "Nursing" section of the conference form was blank.
* IDT Conference notes reflected "Date of Team Conference" was 01/18/2023. Although, the "Attendees" list for the conference included the name of the same nursing staff member who was not identified with their credentials, the form was signed by another person, an RN, on 01/16/2023, two days before the conference, and a second RN on 01/20/2023, two days after the conference. In addition, the entire "Nursing" section of the conference form was blank.
* IDT Conference notes reflected "Date of Team Conference" was 01/25/2023. Although the "Attendees" list for the conference included the name of the same nursing staff member who was not identified with their credentials, the form was signed by another person, an LPN, on 01/23/2023, two days before the conference, and another RN on 01/27/2023, two days after the conference. As for the previous conferences, the entire "Nursing" section of the conference form was blank.

3.b. Three "RN Shift Wound Assessment" forms for Patient 3 were completed and electronically signed by LPNs on 12/08/2022 at 1448, on 12/23/2023 at 2214, and on 01/23/2023 at 1616 .

4. For Patient 4 refer to the findings under Tag A-805 regarding the lack of clear and complete discharge planning documentation.

5.a. For Patient 5 IDT Conference documentation was unclear and incomplete. For example:
* IDT Conference notes reflected the '"Date of Team Conference: 12/20/2022." The sections for "Nursing" and "Wound Care" were completely blank. That was the day after the record reflected the patient was identified with multiple wounds.
* IDT Conference notes reflected the "Date of Team Conference: 12/28/2022." The section for "Nursing" was completely blank, and the section for "Wound Care" stated for "Wound Care on Service: Yes ... Pressure Ulcer(s): 2." The descriptive fields in that section were blank and there was no information to reflect the location of the two pressure ulcers. Further, there were no physician's orders for two pressure ulcers.
* IDT Conference notes reflected the "Date of Team Conference: 01/04/2023." The section for "Nursing" was blank, and the section for "Wound Care" stated only "Wound Care on Service: Yes." There was no other information regarding the patient's wounds.
* IDT Conference notes reflected the "Date of Team Conference: 01/11/2023." The section for "Nursing" was blank, and the section for "Wound Care" stated "Wound Care on Service: Yes ... Pressure Ulcer(s): 1." There was no other information about the pressure ulcer. In addition, an "RRT" electronically signed the form on 01/11/2023 1357. However, in an email from the CMD received on 01/23/2025 at 1451 they confirmed that the staff person who signed as an "RRT" was not an RRT but was licensed as an RN.
* IDT Conference notes for "Date of Team Conference: 01/18/2023" reflected the conference was conducted the day after the patient's discharge. The patient's weight was recorded by the RD as "Nutritional Status Weight ... [114.8]." However, the record reflected that was the patient's weight that had been taken ~ two weeks prior on 01/05/2023.
* IDT Conference notes for "Date of Team Conference: 12/20/2022" reflected the "Nursing" section of the conference form was completely blank. The "Respiratory Therapy" section of the form was incomplete and unclear and reflected "Trach Collar/Capping/Decannulation/PMV [Yes]" (for all of those). However, under "Respiratory Goals/Plan of Care/Actions" the choices for "Trach Collar:" and "PMV:" and "Capping:" and "Decannulation" were blank and unchecked. The "Speech Language Pathology" section was completely blank
* IDT Conference notes for "Date of Team Conference: 12/28/2022" reflected the "Nursing" section of the conference form was completely blank. The "Respiratory Therapy" section of the form was incomplete and unclear and reflected "Trach Collar/Capping/Decannulation/PMV [Yes]" (for all of those). However, under "Respiratory Goals/Plan of Care/Actions" the choice for "PMV" was checked. The choices for "Trach Collar:" and "Capping:" and "Decannulation" continued to be blank and unchecked as for the prior conference. The only additional information related to the PMV was the notation written as "1:1." It was not clear what that meant. The "Speech Language Pathology" section had been partially completed but there was no reference to the PMV.

5.b. For Patient 5, on 12/19/2022 at 1829 an RN signed an "Admit Wound Assessment" on which electronic entries were made and was six-pages long. On 12/28/2022 at 1104 an LPN signed the same "Admit Wound Assessment" under the RN's 12/19/2022 signature. It was unclear why, and unclear which electronic entries had been recorded by the RN and then by the LPN nine days later.

6. For Patient 6 refer to the findings under Tag A-145 that reflected the medical record did not contain clear and complete documentation to describe the communications and sequence of events related to the patient's complaints of abuse.

7.a. For Patient 8 authentication of medical record entries was incomplete, inaccurate, and unclear. For example:
* On 12/04/2023 at 1625 a "Licensed Nurse" whose signature was not specified as RN or LPN signed a note, under a time stamp of 1049 on that day, related to the patient's wounds.
* On 03/04/2024 at 0857 an RRT electronically signed a note under a date/time stamp for service on 3/01/2024 at 1357.
* On 03/06/2024 at 1350 the RRT electronically signed a note under a date/time stamp for service on 01/25/2024 at 1030.
* On 03/06/2024 at 1520 the RRT electronically signed a note under a date/time stamp for service on 12/07/2023 at 1020.
* On 03/06/2024 at 1554 the RRT electronically signed a note under a date/time stamp for service on 12/07/2023 at 1557.
* On 03/07/0224 at 1037 the RRT electronically signed a note under a date/time stamp for service on 03/06/2024 at 1230.
* A staff person repeatedly authenticated their notes and IDT conference entries using the credential of "RRT" over a three-month period. There were ~ 51 medical record entries in progress notes and IDT Conference notes that were electronically signed by the "RRT" from 12/12/2023 at 1625 through 03/07/2024 at 1050. In an email received from the CMD on 01/23/2025 at 1451 they confirmed that the staff person who repeatedly signed the IDT Conference Form as an "RRT" was not an RRT but was licensed as an RN.

7.b. For Patient 8 IDT Conference documentation was unclear and incomplete. Including that it was unclear whether in-person meetings with all disciplines in attendance were conducted. Numerous discipline sections of the IDT conference form had not been completed and were blank. Other sections had not been fully completed. Further, the list of "Attendees" did not align with the staff who electronically signed the conference form on dates that were prior to, or after, the conference date. For example:
* On 12/01/2023 at 1547 an RNCM signed an IDT Conference form. The "Attendees" section showed the "Date of Team Conference: 12/06/2023," five days after the RNCM signed the form, and that only two individuals attended the conference. One was another "Case Manager" who was identified by name and by "MBA, BSN, RN," and the other a "Dietitian." Although no other staff were on the "Attendees" list the form was electronically signed by the following staff on different dates and times between 12/01/2023 and 12/08/2023: An SLP signed on 12/04/2023, an LPN signed on 12/05/2023, an RD signed on 12/06/2023, and an RRT signed on 12/08/2023. The name of the RRT who signed the form on 12/08/2023 was the same name of the "Attendee ... Case Manager: ... MBA, BSN, RN."
* On 12/08/2023 at 1107 an RNCM signed an IDT Conference form. The "Attendees" section showed the "Date of Team Conference: 12/13/2023," five days after the RNCM signed the form, and that only three individuals attended the conference. One was a "Case Manager" who was identified by name and by "MBA, BSN, RN," the second a "Dietitian," and the third was a "Respiratory Therapy" staff. Although other staff were not on the "Attendees" list the form was electronically signed by the following staff on different dates and times between 12/08/2023 and 12/15/2023: An SLP signed on 12/11/2023, an RN signed on 12/12/2023, an RD signed on 12/09/2023, an RRT signed on 12/13/2023, a second RRT signed on 12/15/2023, and a CNA signed on 12/13/2023. The name of the RRT who signed the form on 12/15/2023 was the same name of the "Attendee ... Case Manager: ... MBA, BSN, RN."
* On 12/22/2023 at 1054 an RNCM signed an IDT Conference form. The "Attendees" section showed the "Date of Team Conference: 12/27/2023," five days after the RNCM signed the form, and that only three individuals attended the conference. One was a "Case Manager" who was identified by name and by "MBA, BSN, RN," the second a "Dietitian," and the third was an "RN for [Infection Prevention]." Although other staff were not on the "Attendees" list the form was electronically signed by the following staff on different dates and times between 12/22/2023 and 12/28/2023: An SLP signed on 12/26/2023, an IPRN signed on 12/27/2023, an RD signed on 12/27/2023, an RRT signed on 12/28/2023, and a second RRT signed on 12/28/2023. Again, the name of the RRT who signed the form on 12/15/2023 was the same name of the "Attendee ... Case Manager: ... MBA, BSN, RN."
* The IDT "Attendees" for the "Team Conference: 01/10/2024" were documented as an RNCM, an RD and an RRT. The "Nursing ... Physical Therapy ... Occupational Therapy ... Infection Control ... Pharmacy ... Social Services ... Provider" sections of the conference form were completely blank. There were similar findings as described in the findings above related to the signature dates that did not align with attendance.
* The IDT "Attendees" for the "Team Conference: 01/24/2024" were an RNCM, an RD and an RRT. The "Nursing ... Physical Therapy ... Occupational Therapy ... Infection Control ... Pharmacy ... Social Services ... Provider" sections of the conference form were completely blank. There were similar findings as described above related to the signature dates that did not align with attendance. Although the 01/24/2024 IDT Conference Form documentation did not reflect physician attendance or involvement, a progress note signed by the MD on 01/24/2024 at 1527 reflected "1/24 Case discussed in the IDT meeting including current plan of care and discharge barriers." It was not clear if the MD "discussed" the case as described with only the RNCM, RD, and RRT members of the IDT.
* The IDT "Attendees" for the "Team Conference: 02/07/2024" were an RNCM, an RD, an RRT, and "RN for [Infection Prevention]." The "Nursing ... Physical Therapy ... Occupational Therapy ... Pharmacy ... Social Services ... Provider" sections of the conference form were completely blank. There were similar findings as described above related to the signature dates that did not align with attendance.

* The IDT "Attendees" for the "Team Conference: 02/21/2024" were an RD and an RRT. The "Nursing ... Physical Therapy ... Occupational Therapy ... Infection Control ... Pharmacy ... Social Services ... Case Management Discharge Plan ... Provider" sections of the conference form were completely blank. There were similar findings as described above related to the signature dates that did not align with attendance.
- Although the 02/21/2024 IDT Conference Form documentation did not reflect physician attendance or involvement, a progress note signed by the MD on 02/21/2024 at 1454 reflected "2/21 Case discussed in the IDT meeting including current plan of care and discharge barriers." It was not clear if the MD "discussed" the case as described with only the RD and the RRT members of the IDT. Additionally, on 02/21/2024 at 1512 the CMD signed a Case Management Note that reflected "Participated in IDT meeting to discuss patient and DC needs. MD feels patient is ready for discharge. Therapy feels [patient] is dangerous to continue to work with due to his aggressive behaviors with staff." The information regarding attendance, participation, and discussion in the note was not evident in the IDT Conference notes. The "Nursing ... Physical Therapy ... Occupational Therapy ... Speech Language Pathology ... Infection Control ... Pharmacy ... Social Services ... Case Management ... Provider" sections of the conference form were not completed.

* Similar findings were identified for IDT Conferences dated 12/20/2023, 01/03/2024, 01/17/2024, 01/31/2024, 02/28/2024, and 03/06/2024.

* The physician documented in progress notes that on 01/18/2024 and 02/14/2024 the patient's case was discussed in IDT meetings. However, there was no documentation in the medical record to reflect the IDT met on those dates: On 01/18/2024 at 1536 the MD documented "1/18 Case discussed in the IDT meeting including current plan of care and discharge barriers." On 02/14/2024 at 1515 the MD documented "2/14 Case discussed in the IDT meeting including current plan of care and discharge barriers."

7.c. On "Restraint Order and Flow Record" forms for Patient 8, entries for "RN's initials indicate ... assessment and care provided ... Minimally [every two-hours]" were electronically signed, dated, and timed prior to/earlier than the "[every two-hour]" entries for the shift. Further, the "RN's initials" and the "RN Name" were electronically completed by LPNs on many shift records who also electronically authenticated the forms. Refer to Tag A-175 for the detailed findings related to the documentation on those forms.

7.d. The "Nursing Admission Assessment" for Patient 8 was signed by one RN on 12/01/2023 at 2032 and a second RN on 12/02/2023 at 0404. The assessment for this patient with numerous complexities and needs was largely incomplete and it was unclear what aspects of the "assessment" had been documented by each of the RNs.

8.a. For Patient 9 IDT Conference documentation was unclear and incomplete. For example:
* IDT Conference notes reflected "Date of Team Conference: 01/31/2024," date of the patient's discharge to the acute hospital. The notes further reflected that RN failed to coordinate the provision of care and services to ensure wound healing and prevent infection. For example:
- Under the "Nursing" section the pre-printed choices for "IV antibiotics" and "Wound care which requires extensive time for treatment" and "Resolve improve wounds" were checked. There was no other wound information and no "Comments."
- Under the "Nursing" section the "Nursing Goals" included "Pain management." However, "Pain/alteration in comfort" was checked as "No." There was no other information about the patient's pain or anxiety.
- For "Wound Care on Service?" neither "Yes" or "No" was checked and there was no other wound related information.
- Under "Nutrition Goals/Plan of Care/Actions" only "Sustain adequate hydration" was checked. "Improved wound healing" and other appropriate pre-printed goals were not checked, nor were any custom goals written.
- Under the "Infection Control" section pre-printed choices for "Isolation" and "Other" were checked. A comment next to "Other" was "CRE sputum, hx." In the "Additional Infection Control Comments:" was written "Educated [spouse] upon admission about droplet precautions, wearing a gown while in room and masking." There was no reference to the patient's extensive sacral pressure ulcer, the IV antibiotics, or wound cultures
- The "Pharmacy" section of the conference form, that included "Meds Reviewed" and "Pain Regimen/Requirement" and "Pain Regimen Recommendations," and included a section related to IV antibiotics, was blank.

8.b. For Patient 9 on 01/26/2024 at 0146, three days after admission, an RN signed a "Nursing Admission Assessment" that was also signed by an LPN on 01/29/2024 at 1828, six days after admission. It was unclear why the RN completed the admission assessment three days late and why an LPN signed it three days after that. The assessment was incomplete and it was unclear what aspects of the assessment were documented by the RN versus the LPN.

8.c. For Patient 9, on 01/30/2024 at 1356 an RRT electronically signed a note under a date/time stamp for service on 01/26/2024 at 1530, four days later. Although the entry was in this case identified as a "Late Entry," this was the same staff person who authenticated their entries using a title of "RRT" although it was confirmed they were not an RRT but were an RN.

9. For Patient 13, whose arm was fractured during the provision of nursing care, refer to findings under Tags A-144, A-395, and A-396 regarding the lack of clear, complete, and ongoing nursing assessment of the patient's complex problems and needs, and the lack of clear and complete care plan documentation for the provision of nursing care and services that were coordinated with the other disciplines involved.

10. Other findings cited throughout this report reflected the lack of a clear, complete, and accurate medical records for patients. For example:
* Refer to findings for Patients 8, 9, 15, and 22 under one or more of Tags A-164, A-166, A-168, A-171,and A-175, regarding the lack of clear and complete documentation related to restraint assessment, care plan, physician's orders, and monitoring.
* Refer to findings for Patients 2, 3, 5, 8, 9, 13, 15, 16, 17, 18, 21, 22, and 23 under Tag A-395 regarding the lack of clear, complete, and ongoing nursing assessment of the patient's complex problems and needs, including in coordination with the assessments of the other disciplines involved.
* Refer to findings for Patients 2, 3, 5, 8, 9, 13, 15, 17, 18, 21, and 22 under Tag A-396 regarding the lack of clear and complete care plan documentation for the provision of nursing care and services that were coordinated with the other disciplines involved.
* Refer to findings for Patients 2, 3, 8, 9, 18, and 23 under Tag A-405 regarding the lack of clear and complete medication administration documentation.
* Refer to findings for Patients 2, 3, 8, 9, 18, and 23 under Tag A-500 regarding the lack of clear and complete pharmaceutical services documentation.
* Refer to findings for Patients 5, 8, 22, and 23 under Tag A-620 regarding the lack of clear and complete dietary services documentation.
* Refer to findings for Patients 8 and 9 under Tag A-776 regarding the lack of clear and complete infection prevention documentation.
* Refer to findings for Patients 4, 8, and 13 under Tag A-805 regarding lack of clear and complete discharge planning documentation.
* Refer to findings for Patients 2, 5, 8, and 21 under Tag A-1134 regarding the lack of clear and complete rehabilitation services documentation.
* Refer to findings for Patients 5, 22, and 23 under Tag A-1160 regarding the lack of clear and complete respiratory services documentation.

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11.a. A review of Patient 17's tracheostomy orders reflected that Patient 17 had been "decannulated" on "11/01/2024". The RT note read "Received capped on room air with 98% SPO2 noted. Decannulated on room air with no distress noted."

11.b. A review of tracheostomy care "Administration History" for Patient 17 reflected:
* "Order Description: Trach Care Every Shift, Request Type: Routine"
* "Order Date: 10/17/2024 ... 17:13"
* Tracheostomy Care was documented as "Complete" or "Not Complete" on the following shifts:
11/02/2024 07:36 Complete
11/02/2024 20:19 Complete
11/03/2024 07:39 Complete
11/04/2024 20:20 Complete
11/05/2024 07:00 Complete
11/05/2024 20:25 Complete
11/06/2024 20:48 Complete
11/07/2024 17:02 Complete
11/07/2024 19:00 Complete
11/08/2024 11:36 Complete
11/08/2024 23:28 Complete
11/09/2024 12:20 Complete
11/09/2024 22:46 Complete
11/10/2024 08:12 Complete
11/11/2024 09:00 Complete
11/11/2024 21:35 Not Complete pt decannulated [RT]
11/12/2024 08:23 Complete
11/12/2024 20:18 Complete
11/13/2024 08:11 Complete

Although the patient had been decannulated on 11/01/2024, "nurses" (see 14.d. below) caring for Patient 17 continued to document that tracheostomy care was being performed daily for 12 days, and for seven of 12 days, "trach care" was documented as being performed twice daily.

11.c. A review of Patient 17's Plan of Care reflected that nursing diagnoses, interventions, and goals related to Patient 17's tracheostomy such as goals for decannulation, and tracheostomy care were not addressed.

11.d. During an interview with the RTM on 11/13/2024 at the time of the order review, the RTM stated, "It looks like the nurses have been documenting trach care." The RTM stated that an "RT" had documented on 11/11/2024 at 21:35 that the patient had been decannulated and so did not perform "trach care." The RTM was asked to verify whether an order to discontinue tracheostomy care for Patient 17 had been submitted. The RTM confirmed that there was no order to discontinue the tracheostomy care. The RTM further stated that tracheostomy care was performed by the RTs and not the nurses. When asked why the nurses were documenting the trach care, the RTM could only confirm that RTs perform the trach care and that they document that task.

12. There were similar findings for Patient 18 related to the documentation of tracheostomy care.

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13. For Patient 21 refer to the findings under Tag A-395 for details regarding incomplete and unclear documentation of physician orders and need for assistance during meals.

14. For Patient 22 refer to the findings under Tag A-144 for the findings related to lack of a care plan that addressed the need for an adaptive call light, and Tag A-395 for details regarding incomplete and unclear documentation of skin conditions, including pressure ulcers documented as present on admission.

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DELIVERY OF DRUGS

Tag No.: A0500

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Based on observation, interview, review of medical record documentation for 6 of 6 patients reviewed for pharmacy services (Patients 2, 3, 8, 9, 18, and 23), and review of P&Ps it was determined that the hospital failed to ensure pharmacy services included evaluation of medication orders for appropriateness, patient safety, and conformance with hospital P&Ps, for the hospital's medically complex and vulnerable patients. The pharmacist failed to conduct and document clear and complete review and resolution of patients' medication regimens that included:
* Medication doses ordered above the recommended dosage.
* Medication regimens that included numerous drugs ordered and administered with sedative side effects.
* Unclear physician's orders for medications, including route of administration and PRN indicators.
* Routine and PRN medications not administered as ordered.
* Administration of medication not dispensed by the hospital's pharmacy.

Findings include:

1. During interview with the pharmacist on 11/14/2024 at ~ 1115 about a potential medication allergy for a patient, they stated that that the hospital pharmacists did not regularly conduct reviews of patients' medication regimens on admission.

2.a. For Patient 2, review of the physician orders revealed the following orders for the anti-fungal nystatin to treat the patient's oral thrush:
* On 02/09/2022 order #8 was written by a PA to start at 2100 for "nystatin ... Give [500,000] unit (5 mL) per tube Four Times Daily." The order was written for 10 days with an end on 02/19/2022 at 1700.
* On 02/10/2022 order #40 was written by the PA to start at 1700 for "nystatin ... Give [500,000] unit (5 mL) per tube Four Times Daily." The order was written for 10 days but was discontinued earlier on 02/18/2022 at 1410.

2.b. The current Drugs.com website reflects that the recommendation for the "Usual Adult Dose for Oral Thrush" is "400,000 to 600,000 units of the oral suspension orally 4 times a day. Duration of therapy: At least 48 hours after symptoms have disappeared and cultures demonstrate eradication." Instructions for use included: "Measure liquid doses carefully ... Swish it in your mouth as long as you can before swallowing." The daily total of 400,000 to 600,000 units four times a day was 1,600,000 to 2,400,000 units in a day. However, as the two orders were written the patient would be receiving 1,000,000 units four times a day for a total daily amount of 4,000,000 units. There was no documentation to reflect that the duplicate orders had been discussed with the LIP for clarification and resolution.

2.c. For Patient 2 refer to Tag A-405 for the detailed findings that reflected: The administration of medication for oral thrush exceeded recommended dosages during the first course of treatment ordered on 02/09/2022. As written in the orders and on the MAR the patient was to receive eight doses per day, two doses at each of the four times ordered per day. The MAR reflected that doses given ranged from one dose per day on 02/13/2022 up to eight doses per day such as on 02/14/2022. Numerous doses were not given during that course of treatment with no documented explanation. During a second course of treatment ordered on 03/02/2022 ordered doses were not administered without documented explanation. :

2.d. IDT Conference documentation for Patient 2 lacked documentation that the pharmacist had reviewed the nystatin orders and administration documentation for clarification and resolution: For example:
* The first IDT Conference documentation in the patient's record was a brief narrative for a conference on 03/01/2022. The pharmacist was listed as in attendance however, there was no documentation to reflect the patient's medications/medication regimen was discussed.
* IDT Conference form documentation for 03/08/2022 reflected under the "Pharmacy" section: "IV ABX (1) ... started 3/7 ... Stop Date: 3/14/2022" , anticoag, "Meds reviewed" and APAP for 'Pain regimen. "Pain Regimen Recommendations" and "Additional Pharmacy Comments" were blank. There was no documentation related to the first or second nystatin course of treatment ordered for the patient's oral thrush.
* IDT Conference form documentation for 03/15/2022 reflected under the "Pharmacy" section: Pharm anticoag "Meds reviewed" APAP for 'Pain regimen. "Pain Regimen Recommendations" and "Additional Pharmacy Comments" were blank. As above, there was no reference to the nystatin treatments.

2.e. Excluding IDT Conference documentation there were no other notes by the pharmacist in the patient's medical record.

3.a. For Patient 3 refer to Tag A-405 for the detailed findings that reflected: Regularly ordered pain medication was not administered as ordered and there was no documentation to reflect why doses were missed. There was lack of MAR documentation to reflect the patient-specific reasons that narcotic and non-narcotic PRN pain medications were administered, and the patient's response to those doses.

3.b. For Patient 3 refer to Tag A-395 that reflected that physician orders for application of topical medication during wound care treatments were not clear and were not followed.

3.c. IDT Conference documentation for Patient 3 lacked documentation that the pharmacist had reviewed the patient's medication regimen for conformance with clear physician's orders. For example:
* IDT Conference notes for "Date of Team Conference: 01/11/2023" reflected the "Pharmacy" section of the form lacked clear and complete documentation related to the patient's routine and PRN narcotic and non-narcotic pain regimen, and to the wound medication regimen. One of two references to the pain regimen was under the space for "Pain Regimen/Requirement: Include medication name, dose, frequency and doses given over the last 24 hours (if PRN)." The list recorded in that space by the pharmacist did not include all of the ordered pain medications and it did not include the number of PRN doses administered. The second of two references was under the space for "Pain Regimen Recommendations" where there was nothing recorded. The space was blank. Under "Additional Pharmacy Comments:" was recorded "1/4/23 lab data : 12/27/22 lab data : [creatinine clearance] > 100ml/min ... no renal dosage adjustments warranted : [electrolytes] WNL." It was not clear which lab results were from 01/04/2023 labwork and which were from 12/27/2022 labwork. In addition, there was no information or documentation related to the patient's medication regimen for wound care.
* IDT Conference notes for conferences conducted on 01/18/2023 and 01/25/2023 contained similar unclear and incomplete pharmacist documentation as for the 01/11/2023 conference.

4.a. Patient 8's medication regimen included the following medications that had potential side effects of sedation and drowsiness:
* The anti-parkinsonian drug benztropine mesylate. (Side effects also included confusion, disorientation, nervousness, visual hallucinations worsening of psychotic symptoms, toxic psychosis, aggressive and violent behavior.)
* The blood pressure drug labetalol.
* The muscle relaxant drug baclofen.
* The antipsychotic drug quetiapine fumarate (Seroquel).
* The antipsychotic drug olanzapine (Zyprexa) PRN for "agitation." The order did not describe what behaviors would demonstrate "agitation" for Patient 8 to ensure safe and appropriate administration. (Side effects also included restlessness, back pain, and attention disturbance.)
* The antidepressant drug bupropion HCL. (Side effects also included symptoms of anxiety, agitation, concentration difficulty, and nervousness.)
* The sedative drug diazepam (Valium) PRN for "severe agitation." The order did not describe what behaviors would demonstrate "severe agitation" for Patient 8 to ensure safe and appropriate administration.
* The antihistamine drug diphenhydramine (Benadryl) PRN for "itching."
* The anti-anxiety drug lorazepam (Ativan) PRN IV for "severe agitation." (With additional potential side effects of behavioral disorders.) The order did not describe what behaviors would demonstrate "severe agitation" for Patient 8 to ensure safe and appropriate administration.
* The anti-anxiety drug lorazepam (Ativan) PRN by mouth for "anxiety." The order did not describe what behaviors would demonstrate "anxiety" for Patient 8 to ensure safe and appropriate administration.
* The narcotic pain drug hydromorphone HCL (Dilaudid) IV PRN for pain levels of 10 on pain scale of 1 - 10.
* The narcotic pain drug hydromorphone HCL (Dilaudid) IV PRN for pain levels of 9-10.
* The narcotic pain drug oxycodone PRN for pain levels 6-7.

4.b. For Patient 8 refer to Tag A-405 for the detailed findings that included the amounts of each of those drugs that were given. Those findings reflected: The patient's medication regimen included physician's orders and administration of 12 routinely scheduled and PRN medication orders, that included psychotropics and narcotics, with potential side effects that included sedation or drowsiness, and some of which additionally had potential behavioral side effects. PRN orders did not include clear, objective, and patient-specific indicators for administration, the MAR contained no documentation to reflect the patient-specific reasons for administration, and there was no MAR documentation to reflect the patient's responses to PRN medications given. The patient experienced sedation that interfered with care and therapy on multiple occasions. Refer also to Tag A-395 for the detailed findings that reflected the patient experienced increasing worsening behaviors during the hospital stay.

4.c. There were three pharmacist notes in the medical record and those lacked clear and complete documentation of medication regimen review and identification of potential regimen concerns:
* A "Pharmacy Monitoring Progress Note" signed by a pharmacist on 12/04/2023 at 1130 reflected it was a "Progress Note Type: ... Antibiotics." The note template was primarily incomplete. Although the patient was on the anticoagulant Lovenox and multiple medications ordered that had sedating or behavioral side effects the sections for "Anticoagulation ... Pharmacokinetics ... Respiratory Failure Program ... Renal ... Pharmacy Other" were primarily blank. The only reference to pain was "Pain Regimen: (0-10): 7." The "Anti-anxiety" and "Antipsychotic" sections were blank.
* A "Pharmacy - Admission" note was signed by a pharmacist on 12/05/2023 at 1244. It reflected "Antipsychotic - Is Taking" and "Anticoagulant - Is Taking" and "Opiod - Is Taking." It reflected "Did a complete drug regimen review identify potentially clinically significant medication issue?" which was answered "No issues found during review." However it then answered "Yes" to the question "Did the facility contact a physician (or physician-designee) by midnight of the next calendar day and complete prescribed/recommended actions in response to the identified potential clinically significant medication issues?" There was no further explanation or related information documented.
* The only other documentation in the record by pharmacy was more than three months later on a "Pharmacy - Discharge" note that was signed by a pharmacist on 03/08/2024 at 1029, two days after Patient 9's discharge. It reflected only "Antipsychotic - Is Taking ... Provision of Current Reconciled Medication List to Patient at Discharge: Yes - Current reconciled medication list provided to the patient, family and/or caregiver. Route of Current Reconciled Medication List Transmission to Patient: Other Methods (e.g. texting, email, CDs)." However, the specific method was not denoted and the "comments" space was blank. The note also reflected "Discharge medication teaching provided by nursing" and lastly, the pharmacist answered "Yes" to the question "Did the facility contact and complete physician (or physician-designee) prescribed/recommended actions by midnight of the next calendar day each time potential clinically significant medication issues were identified since the admission?" However, there was no explanation or specific information about such occurrences during the patient's hospitalization, and the "comments" section was blank.

4.d. The pharmacist did not participate in any of the IDT Conferences for Patient 8 and the pharmaceutical aspects of the patient's care were not addressed:
* IDT Conference notes for "Date of Team Conference: 12/06/2023" revealed that the pharmacist was not an "Attendee" and the "Pharmacy" section of the conference form was completely blank. Although the patient received medication by IV, feeding tube, injection, nebulizer, and oral routes that included antibiotics, anticoagulants, antipsychotics, antianxiety, antidepressant, and narcotics for pain, at least 12 of such orders had potential sedation and drowsiness side effects.
* IDT Conference forms revealed that the pharmacist was not an "Attendee" and the "Pharmacy" section of the conference forms were blank and there was no evidence of pharmacist involvement for all of the patient's IDT conferences held on the following conference dates: 12/13/2023, 12/20/2023, 12/27/2023, 01/03/2024, 01/10/2024, 01/17/2024, 01/24/2024, 01/31/2024, 02/07/2024, 02/21/2024, 02/28/2024, and 03/06/2024.

5.a. For Patient 9 the H&P signed by MD 01/24/2024 at 1510 reflected: "History of Presenting Illness ... was started on IV Unasyn on 01-19-2024 and ciprofloxacin on 01-20-2023 with plans to treat for six weeks. Wound cultures were suggesting growth of enterobacter and streptococcus as well as VRE enterococcus ... Assessment: ... Sacral decubitus ulcer with osteomyelitis. Cultures positive for Enterobacter cloacae, CRE ... Plan: ... For the sacral decubitus ulcer, [patient] is on IV Unasyn and Cipro with plans to continue for six weeks."

5.b. Patient 9's medication regimen included the following medications that had potential side effects of sedation and drowsiness:
* Anticonvulsant and nerve pain drug gabapentin.
* Anticonvulsant drug divalproex sodium (Depakote).
* Antihypertensive cardedilol.
* Antiemetic metoclopramide.
* Antidepressant sertraline HCL (Zoloft).
* Narcotic opioid pain drug morphine sulfate.
* Antianxiety drug lorazepam (Ativan) PRN for "anxiety."
* Antiemetic drug ondansetron (Zofran) PRN for "nausea and vomiting."
* Antihistamine drug diphenhyrdramine (Benadryl) PRN for "itching, nausea, anxiety."
* Narcotic opioid pain drug Fentanyl PRN for pain levels of 6-7 on pain scale of 1-10, pain levels 8-10, and pain levels 9-10.
* Narcotic opioid pain drug hydrocodone/acetaminophen (Norco) PRN for pain levels of 6-8.
* Antipsychotic drug olanzapine (Zyprexa) PRN for "agitation."

5.c. For Patient 9 refer to Tag A-405 for the detailed findings that reflected: The patient's medication regimen included physician's orders and administration of 12 routinely scheduled and PRN medications, that included psychotropics and narcotics, with potential side effects that included sedation or drowsiness, and some of which additionally had potential behavioral side effects. The patient experienced sedation during the hospital stay. PRN orders did not include clear, objective, and patient-specific indicators for administration. The MAR lacked clear and complete documentation to reflect the patient-specific reasons for PRN administration and the patient's responses to PRN medications given. Medications were ordered and administered "by mouth" when the patient was "NPO." Medications were not given at the ordered times and some doses were not given at all.

5.d. Pharmacist notes in the medical record lacked clear and complete documentation of medication regimen review and identification of potential regimen concerns:
* On 01/25/2024 at 1500 a Pharmacist "Admission" note reflected that the pharmacist checked boxes to indicate the patient was taking "Anticoagulant" and "Antibiotic" and "Opioid" and "IV Medications ... Antibiotics." Under the section for "Drug Regimen Review" the question was "1. Did a complete drug regimen review identify potentially clinically significant medication issue?" The pharmacist recorded "No issues found during review." However, the following question on the note was "2. If YES - Did the facility contact a physician (or physician designee) by midnight of the next calendar day and complete prescribed/recommended actions in response to the identified potential clinically significant medication issues?" The pharmacist recorded "Yes." The "Comments" section contained a partial list of medications with some lab results and concluded with "Medication profile completed." There was no information to explain the unclear and contradictory "Yes" response to question "2."
* On 01/31/2024 at 1436 a Pharmacist "Discharge" noted reflected that the pharmacist checked boxes to indicate the patient was taking "Antipsychotic" and "Anticoagulant" and "Antibiotic" and "Opioid" and "IV Medications ... Antibiotic ... Other." Under the section for "Drug Regimen Review" the question was "1. Did the facility contact and complete physician (or physician-designee) prescribed/recommended actions by midnight of the next calendar day each time potential clinically significant medication issues were identified since the admission?" The pharmacist recorded "Yes." However, the "Comments" section was blank and there was no information to explain the "Yes" response.

5.e. IDT Conference notes for "Date of Team Conference: 01/31/2024," the date of the patient's discharge to the acute hospital, contained information by some IDT disciplines while the "Pharmacy" section of the form was completely blank.

5.f. In an email received from the CMD on 11/20/2024 at 1143 they stated "After reviewing everything I do not think we gave the patient too many PRN medications to sedate [Patient 9]. I think it was a combination of PRN and scheduled meds that [the patient] was unused to taking as well as [their] medical conditions ... The DC summary [from hospital patient transferred from to Vibra] shows [patient] was put on [medication] there for concerns for seizures. It also notes metabolic encephalopathy and concern for anoxic brain injury. Both of those can see [sic] like the patient is confused/sedated. I don't know what education was provided to the family about [their] medical/cognitive condition and the new medications [they were] taking and their side effects. Adding in the [medication] for itching and the anti-emetic medications and it is not surprising if [patient] was sleeping quite a bit."

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6. For Patient 18 refer to Tag A-405 regarding the use of a topical anti-fungal medication the patient's wound care that was not in accordance with hospital P&Ps or applicable standards of practice.

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7.a. For Patient 23 the MAR was reviewed for sedating medications and reflected the patient had Lyrica 75mg and Risperidone 1mg scheduled for twice daily. Melatonon 3mg at bedtime. Ativan 2mg IV as needed for severe anxiety and Haldol 1mg IV as needed for agitation. The Haldol was given once on 12/20/2024 at 0958. A dose of Ativan was given on the following dates and times: 12/20/2024 0418,12/21/2024 1045, 12/22/2024 0305 and 1820, 12/23/2024 1901, 12/24/2024 2019, 12/25/2024 0443, 12/27/2024 1331, 12/28/2024 0708, 12/29/2024 2113, 12/30/2024 2107, 12/31/2024 0852 and 1810.

7.b. Review of the "Provider Discharge Summary" reflected the following:
* "12/11: increased confusion, agitation and impulsiveness overnight, removed midline requiring IM zyprexa and ativan. Midline replaced. Periods of increased agitation and impulsiveness, buth other times does well following directions."
* "12/12: Continues to have increased agitation and impulsiveness. Rapid response called today for increased agitation and aggression towards staff and [Patient's] family. Requires multiple staff members and ultimatley required bilateral restraints. PRN Haldol ..."
* "12/15: Continues to have episodes of increased agitation and impulsiveness requiring PRN IV ativan. Bedside nurse reports pt has been spitting out most of her PO meds. Bilateral wrist and 4 side rail restraints in place."
* "12/17: Agitation continues, using prn IV ativan."
* "12/18: Agitation, provided prn IV ativan."
* "12/22: More interactive, sitter reports patient mostly calm."
* "12/28: Patient sleeping and has 1:1 sitter, pain appears well controlled."
* "12/29: [Patient] is awake and cooperative, follow simple commands ..."
* "1/2: Midline pulled overnight, order in to replace."
* "1/4: Have stopped Risperdal as patient seems increasingly somnolent. Daughter at bedside ..."
* "1/5: ...more alert ..."

7.c. The medical record lacked any documentation that a pharmacist reviewed and evaluated Patient 23's medication regimen.

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SECURE STORAGE

Tag No.: A0502

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Based on observations, interview, and review of policies and procedures it was determined the hospital failed to ensure drugs and biologicals were managed in a secure manner that prevented access to unauthorized individuals.
* Drugs and biologicals were stored in unlocked cabinets in patient rooms and were accessible to unauthorized individuals.

Findings include:

1. Observations in Patient 19's room on 11/12/2024 at 1235 with IDON revealed an unlocked, wall mounted medication cabinet with multiple medications and wound care supplies including Admelog insulin, Triamcinolone Acetonide ointment, Prescription Strength Arthritis Pain Reliever topical gel, Wound & Burn Dressing Medihoney gel, and Skintegrity wound cleanser.

2.a. Observations of Patient 21's room on 11/12/2024 beginning at 1300 with IDON revealed: an unlocked, wall mounted medication cabinet in the patient's room. The cabinet contained Prescription Strength Arthritis Pain Reliever topical gel, Chlorhexidine Gluconate oral rinse, and an intranasal medication.

2.b. During interview on 11/12/2024 at the time of the observations in Finding 2.a. the IDON stated that all nurses have a key to the medication cabinets and the cabinets should be locked. The IDON confirmed the cabinet that contained medications and was not locked.

3.a. Observations of Patient 23's room on 11/12/2024 beginning at 1430 with IDON revealed an unlocked, wall mounted medication cabinet in the patient's room. The cabinet contained Prescription Strength Arthritis Pain Reliever topical gel, Chlorhexidine Gluconate oral rinse, and two 10 mL single dose vials sterile water for injection, one of which was open.

4. The P&P titled "Administration of Medications" dated last revised "12/22" was reviewed and reflected "Overview of Medication Administration ... Remove appropriate medication from the ADC or the patient's medication cabinet ..." The P&P was not clear where patient medication cabinets were located and if those were the same medication cabinets as those observed in patient rooms. The P&P did not include how medications in the unlocked medication cabinets observed in patient rooms were kept secure and free of tampering. Although staff stated the wall mounted cabinets in patient rooms should be locked and each nurse had a key, that was not reflected in the P&P.

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5. Refer to the Findings in Tag A-405 for Patient 18. An RN performing wound care administered a topical anti-fungal from an unsecured drawer in the patient's room that contained several medications prescribed and provided at another hospital.

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CONTROLLED DRUGS KEPT LOCKED

Tag No.: A0503

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Based on observation of the "1st Floor," it was determined that the hospital failed to ensure that all schedule IV drugs were kept locked within a secure area. Observations and interviews revealed that nursing staff failed to follow hospital policy with respect to storage and disposal of controlled drugs from the Pyxis Automated Medication Dispensing System.

Findings include:

1. The P&P titled "Administration of Medications" dated "Review Date 10/24," was reviewed. It reflected:
* "Prepared medications may never be left unattended at the patient's bedside without a licensed practitioner's order. These should be kept in a designated place that is separate from all other possibly ingestible items."
* "When administering partial tablet doses (e.g., where the dose equals ½, 1/4 tablet, etc.) the dose should be determined and the remaining tablet discarded in the 'Drug Buster' (unless special "hazardous drug" handling instructions). Do not keep partial tablet doses for administration at a later time. (See Policy 'Nurse Handling of Controlled Substances' relative to the proper documentation (with witness) of controlled drug partial doses and wastage.)"

2. A tour of the 1st Floor starting at 1425 on 11/12/2024 with the CEO and an RN was conducted. Observations in Patient 31's room revealed a vial of Ativan IV left on a bedside counter above the patients bed with a small amount of clear liquid in it. The RN stated "they did not give the patient Ativan on this shift and did not know why it was there." The patient stated "the wound care RN found the vial in my bed during a dressing change and put it there." The patient also confirmed they had not received Ativan on this shift. The RN took the vial and gave it to the Charge RN.

3. The RN confirmed at the time of finding the vial that Ativan should not have been left in the room and should always be locked up or wasted using the two person verification process.

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DIRECTOR OF DIETARY SERVICES

Tag No.: A0620

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Based on observation, interviews, review of medical records for 4 of 5 patients reviewed for aspects of dietary and nutritional services (Patients 5, 8, 22 and 23), review of P&Ps, and review of manufacturer's instructions it was determined the hospital and the director of dietary services failed to ensure the provision of safe and appropriate dietary and nutritional services to its medically complex and vulnerable patients. Failures included:
* Dietary and nutritional needs assessments and re-assessments were not clear and complete.
* Weight loss, and inadequate food and nutrition intake, experienced during the hospital stay was not clearly identified and tracked, and interventions implemented.
* Tube feedings were not administered continuously in accordance with physician's orders.
* Tube feeding systems were not managed in accordance with manufacturer's instructions.
* Tube feeding formula was not stored in accordance with policies and procedures and manufacturer's instructions.
* Expired tube feeding formula was available for patient use.

Findings include:

1.a. For Patient 5 dietary services documentation of assessment, provision of care, and coordination with other disciplines regarding the patient's weight loss was not clear or complete. For example:
* On 12/19/2022 at 1906 an RD signed a Registered Dietitian Progress Note that reflected "Weight: [136.2 lbs. on 12/16/2022] ... Diet: NPO Intake/Meal: ... TF: DHT ... Currently NPO and nutrition per PEG. Recommendations: 1. Provide nutrition per DHT. TF as ordered. Adjust as needed to support nutrition. 2. Advance to oral diet per SLP eval and MD order. If PO diet is appropriate, offer Carbohydrate Controlled Diet. 3. Monitor TF tolerance, weight, lab, bowel routine, hydration status and change in needs." The dietician's note contained unclear and conflicting information related to the type of tube feeding such as reference to a "DHT" which is a Dobhoff nasogastric feeding tube inserted manually through the nose down into stomach, and in the same note reference to the patient's nutrition "per PEG" which is Percutaneous Endoscopic Gastrostomy, a surgically inserted tube through the abdominal wall into the stomach.
* On 12/26/2022 at 1508 an RD signed a "Registered Dietitian Progress Note" that reflected "Weight: [113.5 lbs. on 12/24/2022], [136.2 lbs. on 12/16/2022] ... Diet: NPO Intake/Meal: ... TF: DHT ... Patient complains of hunger ... [Family] present at bedside [who] reports they were discussing the possibility of Pt eventually getting PEG. DHT placed 12/10 ... Pt working with SLP ... history of poor appetite ... Pt weight is down by [22.7 lbs.] in 1 week, suspect weighing error." The RD recommendations did not include coordination with nursing to assess and confirm the patient's significant weight loss.
* On 12/30/2022 at 1740 an RD signed a "Registered Dietitian Progress Note" that reflected "Weight: [132 lbs. on 12/29/2022], [114.4 lbs. on 12/28/2022], [137.3 lbs. on 12/27/2022], [113.5 lbs. on 12/24/2022], [136.2 lbs. on 12/16/2022 (admission)], [132.2 lbs. prescreen], [12/29/2022 114.4 lbs.] after room move ... Current wt is 132 lbs ... Noted variable wts, but wt is closed [sic] to [their] baseline admit wt ([132.2 lbs.])." It was unclear what "after the room move" meant in relation to the weight loss and did not explain the fluctuating weights down to 113 and 114 lbs on two different dates. The RD note also reflected "Diet: NPO except ice, 1:1 Assist (12/30), stop when cough ... " It was not clear what was meant by "1:1 Assist" in relation to the patient's diet and who on staff was allowed to "assist" this NPO patient and with what. A physician's order for 1:1 assist did not follow until the next day.
* On 01/07/2023 at 2256 an RD signed a "Registered Dietitian Progress Note" that reflected the patient's weight on 01/05/2023 was 114.8 lbs. for a loss of 17.2 lbs since the previous RD note on 12/30/2022. The note reflected "Wt is stable since bed scale adjustment." It was not clear when a "bed scale adjustment" was made nor what "stable" meant when the patient's weight was down to 114.8 lbs.
* On 01/11/2023 at 1216 an RD signed a "Registered Dietitian Progress Note" that reflected the last weight was the 01/05/2023 weight reported in the 01/07/2023 RD note above that had reflected a 17.2 lbs. weight loss. There was no indication of a patient weight since 01/05/2023. The note reflected "Pt continues to complain of feelings of hunger. Pt TF provided per I&O's over the past 6 days ... Days 1/10, 1/8, 1/7 missing information, it is likely that TF provided may be higher than ~1346ml [per day]. Pt would benefit from starting Volume Based Feedings (VBF) to ensure Pt receives entire tube feeding that is ordered. Pt DHT occasionally gets clogged (last clogged 1/10). Pt with severe muscle wasting and fat loss ... Pt allowed to have PO snack of yogurt when not on vent with 1:1 assistance. Last BM noted is 1/7 per I&O's, will confirm with nurse ... significant weight loss of [19.4 lbs.] in <3 months, Severe muscle wasting, and severe fat loss." This 01/11/2023 note was the last RD "progress note" in the patient's record. It reflected there was missing information about the patient's intake, the feeding tube became clogged on multiple occasions, and the patient had significant weight loss. There was no further assessment of those problems by the RD, including in coordination with the RN, during the remainder of the patient's hospitalization that ended on 01/17/2023.

1.b. For Patient 5 refer also to Tag A-395 for additional details regarding lack of coordination of dietary services with nursing and other services.

2.a. For Patient 8 dietary services documentation of assessment and coordination with other disciplines regarding the patient's weight loss was not clear or complete. For example:
* IDT Conference notes for "Date of Team Conference: 12/06/2023" reflected under the "Nutritional Status" section "Weight [191.5] ..."
* IDT Conference notes for "Date of Team Conference: 12/13/2023" reflected under the "Nutritional Status" section "Weight [183.6] ... PEG (11/22) Jevity 1.5 70 ml/h ... NPO except ice ... Inadequate PO nutrition ... Nutrition Goals ... Sustain adequate hydration." The patient's weight reflected a loss of 7.9 lbs from the previous IDT Conference weight of 191.5 lbs. Yet the only goal was "Sustain adequate hydration." The goal was not patient-specific and measurable, and did not reflect the patient's weight loss.
* IDT Conference notes for "Date of Team Conference: 12/20/2023" reflected under the "Nutritional Status" section "Weight [180.8] ... PEG (11/22) Bolus via syringe Jevity ... [five times] per day. Diet: General Diet, Puree Texture Thin Liquid ... Nutrition Goals ... Sustain adequate hydration ... Sustain adequate food intake ... Additional Nutrition Comments: Ensure Compact with meals." The patient's weight reflected a loss of 10.7 lbs from the first IDT Conference weight of 191.5 lbs. Yet there remained no patient-specific and measurable goal related to the weight loss. It was not clear what "adequate food intake" was for Patient 8.
* IDT Conference notes for "Date of Team Conference: 01/03/2024" reflected under the "Nutritional Status" section: "Weight [176.3] ... TF hold, has PEG in place ... Diet: General Diet, Puree Texture Thin Liquid - Intake %: [greater than] 25 ... Inadequate PO nutrition ... Nutrition Goals ... Sustain adequate hydration ... Sustain adequate food intake ... Additional Nutrition Comments: Ensure Compact with meals." The patient's weight reflected a loss of 15.2 lbs from the first IDT Conference weight of 191.5 lbs. Again, there remained no patient-specific and measurable goal related to weight loss and it was not clear what "adequate food intake" meant.
* IDT Conference notes for "Date of Team Conference: 01/17/2024" reflected under the "Nutritional Status" section: "Weight [162.8] ... Enteral feeding: [blank] ... Diet: General Diet, Minced & Moist Texture Thin Liquid - Intake %: [varies] ... Inadequate PO nutrition ... Nutrition Goals ... Sustain adequate hydration ... Sustain adequate food intake ... Additional Nutrition Comments: Ensure HP Plus w/ meals. Frequent Snacks." The patient's weight reflected a loss of 28.7 lbs from the first IDT Conference weight of 191.5 lbs. There remained no patient-specific and measurable goal and it was not clear what "adequate food intake" meant.
* Although Patient 8 lost more than 28 lbs in a matter of six weeks, the RD's IDT assessments did not identify the loss, there were no patient-specific and measurable goals related to the patient's weight and "adequate food intake," and there were no patient-specific interventions identified, including in coordination with other disciplines. Further the patient's weight loss, bolus syringe feeding via the PEG (including who was to perform that task that had aspiration and other risks associated with it), pureed diet with thin liquids, and the Ensure supplement were not addressed on the patient "Plan of Care Complete Plan."

2.b. For Patient 8 refer also to Tag A-395 for additional details regarding lack of coordination of dietary services with nursing and other services.

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3.a. Failure to ensure tube feeding systems were managed in accordance with manufacturer's instructions:

3.b. Observations of Patient 22 on 11/12/2024 beginning at 1250 with IDON revealed:
* An enteral tube feeding system at the bedside that included a pump, a 1000 mL water bag, an administration set with tubing, and a one liter container Jevity 1.5 Cal formula.
* The water bag had a label with "11/10/24" and "0345" handwritten on it.
* The manufacturer's instructions on the water bag read "Discard administration set ... after 24 hours of initial usage."

3.c. During interview 11/12/2024 at the time of the observations the IDON stated the water bag dated "11/10/24" and "0345" meant they were last changed on 11/10/2024 at 0345 and were due to be changed 11/11/2024 at 0345. The IDON stated "That is old and should've been changed last night." The IDON acknowledged it had not been changed.

3.d. Observations of Patient 23 on 11/12/2024 beginning at 1430 with IDON revealed:
* An enteral tube feeding system at the bedside that included a pump, a 1000 mL water bag, an administration set with tubing, and a one liter container Pivot 1.5 Cal formula.
* The water bag had a label on it with "11/11" and "1000" handwritten on it.
* The manufacturer's instructions on the water bag read "Discard administration set ... after 24 hours of initial usage."

3.e. During interview on 11/12/2024 at the time of the observation of the tube feeding system, the IDON stated the water bag should have been changed by 11/12/2024 at 1000. The IDON acknowledged it had not been changed.

4.a. Regarding failure to administer tube feeding in accordance with physician's orders:

4.b. Observations of Patient 22 on 11/13/2024 beginning at 1040 with IDON, an RN and a CNA revealed an enteral tube feeding system at the bedside that included a pump, a 1000 mL water bag, a one liter container Jevity 1.5 Cal formula, and administration tubing. The system was not running during observations from 11/13/2024 at 1040 through 1130.

4.c. During interview on 11/13/2024 at 1115 the RN who was present during the observations of Patient 22 in Finding 4.b. above stated the patient had a G-tube and their tube feeding should be running continuously.

4.d. During an interview on 11/13/2024 at 1200 with the same RN who was present at the time of the observations of Patient 22 in Finding 4.b. above stated they thought the patient's tube feeding was turned off at "ten or ten-thirty" and they did not know who turned it off.

4.e. During interview on 11/13/2024 at 1205 the CNA who was present at the time of the observations of Patient 22 in Finding 4.b. above stated they did not know when the patient's tube feeding was turned off.

4.f. Review of Patient 22's medical record with IDON reflected the patient was admitted to the hospital on 10/25/2024 with diagnoses that included respiratory failure, encephalopathy, physical deconditioning, dysphagia, and severe protein calorie malnutrition. The record contained:
* A physician's order, "Dietary (2) Orders" dated 10/25/2025 at 1005 with start date 10/25/2024 at 1900 and "Duration: 999 Days" reflected "Description: Tube Feed Order Every Shift ... Route: PEG ... Delivery Method: Pump Feed ... Jevity 1.5 65 ml/[hour]".
* A physician's order, "Tube Feeding Formulary Orders" dated 10/25/2024 at 1006 with start date 10/25/2024 at 1800 and "Duration: 999 Days" reflected "Description: Free Water Flush Every Four Hours, Route Type: PEG ... Flush Amount (mL): 95, Comments [Free Water Flush]: 95 ml [every] 4 [hours] = 570 ml/day".

4.g. During interview at the time of Patient 22's medical record review the IDON stated the physician's order for tube feeding "Jevity 1.5 65 ml/[hour]" meant the patient's tube feeding should be running continuously. The IDON confirmed the orders were not followed 11/13/2024 from at least 1040 through 1130 as the tube feeding was observed turned off during that time and it was not clear when it was turned off, why, or by whom.

4.h. Review of documentation in Patient 22's medical record on 11/18/2024 revealed no information in the nurse progress notes that described how long or why the patient's tube feeding was not running on 11/13/2024.

5.a. Regarding failure to store tube feeding formula in accordance with P&Ps and manufacturer's instructions and ensure expired tube feeding formula was not available for patient use:

5.b. During tour of Floor 3 with IDON on 11/12/2024 at 1525 containers of tube feeding formula was observed on open shelves in a Nutrition Room. The light was on in the Nutrition Room. At least seven containers were expired including two 1-Liter containers Nepro With Carbsteady with "Use Before" date 10/01/2024; one 1-Liter container Nepro With Carbsteady with "Use Before" date 09/01/2024; two 1-Liter containers Vital AF Advanced Formula 1.2 Cal with "Use By" date 07/01/2024; and two 1-Liter containers Vital AF Advanced Formula 1.2 Cal with "Use By" date 05/01/2024.

5.c. The manufacturer's instructions on the label of one of the Vital AF Advanced Formula 1.2 Cal containers observed in Finding 5.b. reflected "Use by date on container ... Protect contents from light during storage."

5.d. The manufacturer's instructions on the label of one of the Nepro With Carbsteady containers observed in Finding 5.b. reflected "Use by date on container ... Protect contents from light during storage."

5.e. During an interview on 11/12/2024 at the time of the tube feeding formula observations, the IDON confirmed the tube feeding formula was expired.

5.f. During an interview on 11/12/2024 at 1525 the IDON stated the Dietary Department was responsible for managing tube feeding but they did not know who was responsible for stocking tube feeding formula.

6. The P&P titled "Enteral Nutrition Formulary/Enteral Nutrition Support" dated last revised "1/23" was reviewed and reflected "Approved enteral nutrition products available in individual cartons or ready-to-hang closed systems are provided to patients unable to consume adequate nutrients via oral intake alone. Patients receiving enteral nutrition support will have nutrition interventions designed to meet the patient's estimated nutrition needs ... Enteral nutrition products are stored so as to maintain formula integrity and stability ... Enteral nutrition formulas are stored in dark, dry, room temperature conditions, per manufacturer's recommendations, on covered shelves or in a closed cabinet ..."

40575

7.a. During tour of Floor 1 with CEO on 11/12/2024 at 1230 bags of tube feeding formula were observed on open shelves in a Nutrition Room. The light was on in the Nutrition Room. At least four bags were expired including two bags of Novasourse Renal with "Use Before" date 11/01/2024.

7.b. During interview on 11/12/2024 at the time of the tube feeding observations, the CEO confirmed the tube feeding formulas were expired.

8.a. Review of Patient 23's I/O flowsheets reflected poor PO intake. For example:
* 12/26/2024 Refused Breakfast/Lunch, Ate 50% of Dinner
* 12/27/2024 Breakfast 15%, Lunch 2%, Dinner 10%
* 12/28/2024 Breakfast 5%, no documentation for Lunch/Dinner
* 12/30/2024 Breakfast 0%, Lunch 0%, Dinner 5%
* 01/01/2025 Breakfast 75%, Lunch 50%, no documentation for dinner
* 01/02/2025 No meals documented
* 01/03/2025 No documentation for Breakfast, Lunch 10%, Dinner 10%
* 01/04/2025 Breakfast refused, Lunch refused, no documentation for dinner

8.b. The "Interdisciplinary Team Conference Form" dated 12/26/2024 electronically signed by the RD reflected the following:
* "Weight (kgs): 58.60"
* "Diet: General Diet, Pureed Texture Thin Liquid"
* "Intake %: vari"
* "Albumin: 3.3"
* The box for "Inadequate PO nutrition" was checked with the comment "inadequate oral intake d/t cognitive issue, may nee [sic] DHT to provide continuous nutrition support."

8.c. The "Interdisciplinary Team Conference Form" dated 01/02/2025, electronically signed by the RD reflected the following:
* "Weight (kgs): 62.30
* "Diet: General Diet, Pureed Texture Thin Liquids"
* "Intake %: poor"
* "Albumin: 3.3"

8.d. The "Provider Discharge Summary" dated 01/05/2025 reflected the following notes:
* "12/15: Poor po intake. Will need RD to assess needs for TF in the morning ... Continues to have episodes of increased agitation and impulsiveness requiring PRN IV ativan."
* "1/3: Poor po intake - approx 25%. [Sodium] 148, attempting repeat [basic metabolic panet]. Getting 1 L NS to maintain hydration."
* "Patient seen and evaluated on daily rounds, still with poor po intake but more alert. Sitter in place. Able to drink ensure but refusing food. Planning for repeat CT Head tomorrow am."
The patient had poor po intake and low albumin levels. A feeding tube had been suggested by the RD, but was not ordered prior to the patient's death on 01/05/2025.

44104

9. Refer to Tag A-750, Findings which reflected that several expired enteral nutrition formulas were available for patient use, and were stored exposed to light, contrary to manufacturer's IFUs and hospital P&Ps. Additionally, other expired food items were observed available for patient use in nutrition areas.

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MAINTENANCE OF PHYSICAL PLANT

Tag No.: A0701

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Based on observation and interview it was determined the hospital failed to ensure the condition of the physical environment was maintained in good repair and kept clean in order to ensure the safety and well-being of patients as follows. The walls, flooring, furniture and other surfaces were not kept clean and in good repair, and were not maintained in a manner to ensure the surfaces were cleanable.

Findings include:

1. A tour of the First Floor Nursing Unit on 11/12/2024 beginning at 1425 with the CEO and POD, observations included but were not limited to:
* In the Soiled Utility Room the wall next to the sink had areas of peeling and chipped paint with a brown discoloration that was not cleanable and was in disrepair. There were also two large gray bins, one was half full of garbage making it difficult to enter the room.
* In the Clean Utility closet the covered clean linen cart had 2 bags of laundry on the top that were in clear plastic bags with a open vent screen coming down from the ceiling.
* In the Patient Shower room labeled "Shower 120 D," several large metal and plastic shower chairs stacked up onto each other that had black hair on two of them. A bedside table was seen with hygiene products (shampoo, liquid soap), chux pads, and wash cloths in a gray plastic bucket. One of the white bottles was laying sideways in the bucket with the lid open.
* In the Nutrition Room, under the sink, the base floor molding was peeling away from the wall showing the wall with peeled paint and there was a gray bucket and towel laying under the sink. The refrigerator door's bottom shelf had a dark colored substance next to glucerna containers.

2. During tours of the Second Floor high-acuity unit on 11/12/2024, 11/13/2024, and 11/14/2024, with the EH/IP-PD, the RTM and the IDON, respectively, observations included but were not limited to:
* A stained ceiling tile was observed in the clean supply room, directly above tube feeding supplies such as tube feeding sets and PEG protectors.
* Cabinets under sinks in both nurses' stations, med prep areas and nutrition room were screwed shut and when opened revealed visible water marks, dirt, stained wood, rust from pipes, and unsealed, open areas in the dry wall where rodents or insects could enter.
* The housekeeping closet floor sink had layers of built-up coarse sediment around the edges of the sink basin. There were missing ceiling tiles, exposing pipes. The left-hand side of the cleaning chemical dispenser was broken and could not be unlocked; the viability of the chemicals (expiration dates) could not be verified. The drywall on the left-hand side of the closet was damaged and created an uncleanable surface.
* The countertop at the nurses station revealed it was in disrepair with areas of chipped and missing laminate.

3.a. During tour of Third Floor on 11/12/2024 beginning at 1200 and 1500 with the IDON, observations included but were not limited to:
* In a Housekeeping Room, a wood cabinet under the handwashing sink was opened and revealed brown and gray dirt and water stains. A hopper was observed with dirty water and yellow staining in the bowl, and a piece of duct tape stuck to the upper edge of the bowl. The hopper had a clear barrier that extended over the top of the bowl. Mop heads were piled on top of the hopper barrier. Mops, mop handles and other items were disorganized and leaning against the hopper and in the space between the hopper and adjacent sink cabinetry.
* In a Housekeeping Closet, there was thick, dark gray grime inside the floor drain pan. Dust and dirt were observed on the closet floor and floor molding.
* In a Clean Supplies Room, an area of linoleum floor had been cut away under a shelving unit exposing the linoleum adhesive. The cut away surface was uneven and dirty. Lancets, containers of blood glucose test strips and other patient supplies were observed on the shelf directly above this. A small wall mounted box with exposed wires was screwed into the wall directly above a hand hygiene dispenser.
* In the hall across from patient Room 303, rough patch material, deep gouges and an exposed drywall anchor were observed directly under a wall mounted hand hygiene dispenser.
* At the nurses station, a large section of countertop with what appeared to be intentional cut marks that created grooved lines in the countertop. Two corners of the grooved area were chipped exposing the wood surface beneath. At least two other areas were cracked and chipped. The countertop trim had areas of missing paint or varnish.
* At the elevator entry, areas of scraped paint on the elevator door frame.
* In a medication room, gouged drywall and six exposed drywall anchors were observed in the corner between the medication refrigerator and the automated medication dispensing machine.

3.b. During tour of Third Floor on 11/14/2024 beginning at 1245 with the IDON, observations included but were not limited to:
* At the nurses station, the countertop was in disrepair with areas of chipped and missing laminate.
* Refer to Tag A-750 regarding Third Floor shower room that reflected it was in disrepair and appeared unusable.

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29708

LIFE SAFETY FROM FIRE

Tag No.: A0709

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Based on observation and interviews it was determined that the hospital failed to comply with the Life Safety From Fire requirements as indicated on the attached Fire Life Safety CMS 2567 SOD report.

Findings include:

1. During tour of Floor 3 on 11/12/2024 at 1505 and 11/14/2024 at 1240 with IDON, observations in a medication room revealed two power strips (power strip one and power strip two) with six outlets each. The power strips were connected to each other "daisy chain" style. Both power strips had equipment/items plugged into them:
- Power strip one had a computer workstation/monitor plugged into it.
- Power strip two had a manufacturer's warning on the back that read, "Caution to reduce the risk of electrical shock ... Do not plug into another relocatable power taps ..."
- Power strip two had a computer, medication refrigerator, and power strip one plugged into it.

2. The power strip observations were conveyed to LSC surveyors for evaluation.

3. Refer to the K-Tag findings under the Fire Life Safety CMS 2567 SOD report.

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FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE

Tag No.: A0724

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Based on observations, interviews and review of records and other documents, it was determined that the hospital failed to develop and implement a preventive maintenance program to ensure biomedical equipment and other hospital appliances were maintained in safe working order.

Findings include:

1.a. The P&P titled, "Preventative Maintenance Program", with a last review date of "1/24" was reviewed and reflected:
* "The Plant Operations personnel ... will perform all preventative maintenance within our facility that is not covered by Biomedical or service contracts."
* "Maintenance personnel will follow manufacturer's recommended procedures and maintenance schedules on all equipment."
* "Hard copies of maintenance activities/logs in lieu of 360 Facility will be stored in the Maintenance/Engineering Department."

1.b. The P&P titled, "Non-medical Electric Equipment Control", with a last review date of "1/24" was reviewed and reflected:
* "The Plant Operations Department will perform basic safety checks on non-clinical line powered electrical equipment ... This program will cover both existing and newly purchased assets based on their assessed risk as determined by the Director of Plant Operations. The program will focus on the environmental conditions present that significantly increase the risk of electrical failure or increase the possibility of electrical incident."
* "Non-Clinical Patient Contact - line powered equipment in direct contact with the patient or staff ... Items under this heading would include electric beds, hair dryers, portable air conditioning units, etc. Hospital policy forbids the use of any patient owned equipment being brought into the hospital unless it is battery powered."
* "Non-Clinical, Non-Patient Contact - line powered electrical equipment having indirect contact with patients ... Items under this heading would include, computer screens, typewriters, date stamp machines, refrigerators, vacuums, buffers, etc."
* "Risk Assessment ... High Risk Areas - these areas where electrical equipment is used which significantly increases the risk of electrical incident, for example: ICU, the Hydrotherapy section of Physical Therapy, kitchens, maintenance shops, etc. ... Low Risk Areas - all other areas not defined under high risk area. For example, Patient Accounting, Payroll, etc. ... High Risk Equipment - those devices that are used within the hospital in ways that increase the likelihood of an electrical incident. For example, floor buffers, portable shop tools, electrical razors, etc."
* "Non-Clinical Electrical Testing ... All items such as: vacuum cleaners, refrigerators, microwaves, coffee makers, desk lamps, typewriters, etc., will not be included in this program unless they are deemed an electrical hazard due to their close proximity to invasive clinical patient care. all [sic] users shall either direct the Materials Services Department to deliver their non-patient care electrical powered equipment directly to the Plan Operations Department or they shall, upon receipt and before using, request an initial inspection. The Plant Operations Department shall have final authority on the acceptance and usage of all non-patient care electrical powered equipment."
* "Newly Purchased Assets - All newly purchased items delivered to the hospital will first be brought to Plant Operations for inspection. All items will contain two (2) copies of diagrams and parts booklets. After inspection, the equipment will be returned ... for delivery to the department. One copy of the booklet will be forwarded with equipment and one retained by Plant Operations. Plant Operations will have final authority on safety of all devices. Re-inspection intervals to be determined by the Director of Plant Operations."
* "Records: Written records documenting all HIGH RISK non-clinical electrical equipment test schedules shall be maintained by Plant Operations. Additionally, all corrective actions for each item shall be documented."
* "Tagging: Newly purchased equipment of a HIGH RISK nature will have a permanent tag installed at the time of initial inspection."
* "Existing equipment of a HIGH RISK nature will have a permanent tag installed at the time of initial inspection."

1.c. The P&P titled, "Inspection, Testing, & Maintenance of New Medical Equipment" with a review date of "10/24" was reviewed and reflected:
* "The Hospital's activities and frequencies for inspecting, testing, and maintaining will be in accordance with manufacturers' recommendations for new equipment. "
* "The Biomedical Engineering Contracted Services will inspect, test, and maintain in accordance with manufacturers' recommendations for the following items ... Equipment subject to federal or state law or Medicare Conditions of Participation in which inspecting, testing, and maintaining be in accordance with the manufacturers' recommendations, or otherwise establishes more stringent maintenance requirements."
* "Documentation of testing of these devices will be maintained by Biomedical Engineering Contracted Services, included in the Maintenance Management System (MMS). The documentation will include the maintenance history and any of the following documented evidence ... Records provided by the hospital's contractors ... Records of the hospital's experience over time ..."
* "The Biomedical Engineering Contracted Services assures that scheduled testing of new equipment is performed in a timely manner."

2.a. During a tour of the second-floor, high-acuity medical unit on 11/12/2024 with the EH/IP-PD beginning at 1200, the following biomedical equipment as well as non-clinical equipment was observed:
* A scale in a shower room used as a storage room without calibration stickers, or other identifying biomedical tracking sticker.
* A "Sharp" commercial microwave in the staff break room without a hospital electrical "Safety Checked" sticker or other identifying biomedical tracking sticker.
* A "Curtis" commercial coffee maker in the staff break room without a hospital electrical "Safety Checked" sticker or other identifying biomedical tracking sticker.
* A "Mr. Coffee" residential coffee maker in the staff break room without a hospital electrical "Safety Checked" sticker or other identifying biomedical tracking sticker.
* A black residential space heater in a decommission bathroom located in the Medication Room had a hospital electrical "Safety Checked" sticker with a date of "5-31-17". There was no other tracking number to ensure that preventive maintenance checks were performed per manufacturer's recommendations, or whether the hospital was tracking the heater as part of its preventive maintenance program.
* A lift in a shower room 227 used as a storage room had an "ISS Solutions" sticker with an inspection date of either "B-24" or "8-24" and an "Inspection Due" date of either "B-25" or "8-25" followed by the initials of either "Do", "DJ" or "Du". It was unclear whether the numbers 24 and 25 represented the year or the day. An ISS Solutions inventory bar code sticker contained the following number "050417643".

2.b. During a tour of the third-floor medical unit on 11/12/2024, beginning at 1200 with the IDON, the following biomedical equipment and other appliances were observed:
* A "Sharp" commercial microwave in the nutrition room with a green hospital electrical "Safety Checked" sticker with a blank "Date" line followed by a signature. Also on the sticker were the following 4 entry sections: "Electrical" followed by an illegible entry; "Leakage" followed by an illegible entry; "By" followed by an illegible entry and "9-21-21"; and "Date next check" which had a blank entry. There was no other identifying biomedical tracking sticker.
* An "American Biotech Supply" medication refrigerator located in the medication room with a green hospital electrical "Biomedical Engineering Dept Safety Check" sticker with a "Date" line with an illegible but possible date of "4/6/23". It was unclear whether the date was the date a check was completed or a next inspection due date. There was no other identifying biomedical tracking sticker.

2.c. Beginning on day 1 of the survey, 11/12/2024, and throughout the survey, observed in the conference room used by the hospital survey team was the following:
* A "Pelonis" residential oil heater without a hospital electrical check sticker or other identifying biomedical tracking sticker.

3. During a review of the Preventive Maintenance Program on 11/14/2024 with the Plant Operations Director (POD) and the CEO beginning at 1130, the POD confirmed Findings 1.a.-2.c. Regarding the microwave in the second-floor break room the POD stated that it was "not properly checked" or brought into the engineering department for checking. Regarding the space heater in the second-floor medication room, the POD confirmed that a manufacturer manual did not exist for the heater and could not ensure that preventive maintenance was being performed on the appliance in accordance with hospital P&Ps. The POD additionally confirmed that items without inventory stickers could not be tracked and therefore the hospital was not able to ensure that electrical safety checks or other preventive maintenance requirements were being followed. The POD was asked to verify the dates of preventive maintenance performed on the lift with a tracking number 050417643, and after approximately 50 minutes of reviewing the preventive maintenance log, the POD and the CEO were unable to locate the item or the history of the identified biomedical equipment, even with the provided tracking number. The Biomedical company, ISS Solutions, with which the hospital contracted its biomedical services was not able to provide the history of the identified biomedical equipment by the close of the survey, even with the provided tracking number.

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INFECTION CONTROL PROFESSIONAL

Tag No.: A0748

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Based on interview, review of IP P&Ps, review of 2 of 2 Employee records (Former Employee # 1 and Employee # 2), QA meeting minutes, and other documentation, it was determined that the hospital failed to ensure it clearly identified and designated an infection preventionist(s) who was qualified and responsible for the development and implementation of an IP program specific to the Portland VSH.
* The hospital failed to ensure the governing body appointed an infection preventionist(s)/infection control professional(s) responsible for the IPC Program.
* The hospital failed to ensure that the appointment of an infection preventionist(s)/infection control professional(s) was based on the recommendations of medical staff leadership and nursing leadership, and who was qualified through experience, education, training or certification in infection prevention principles, including HAI surveillance.
* P&Ps and other documents regarding an infection preventionist for the hospital were inconsistent and did not clearly identify an infection preventionist(s)/infection control professional(s) designated for VSH.
* Training documents for the former IP and the current IP were incomplete and lacked verification of training in IP principles, such as HAI surveillance.

Findings include:

1. An organizational chart dated as "Revised April 8, 2024" was reviewed and reflected:
* An Infection Prevention and Control Department or program was not listed on the organizational chart. An IP professional was not noted under any of the other listed departments.
* A physician responsible for the IP department was not listed.

2. The policy titled, "Infection Control & Prevention Plan", with a review date of "4/24" was reviewed and reflected:
* "Statement of Purpose ... The Infection Prevention Program will comply with Federal ... regulatory laws."
* "Vibra ... Identified Goals and Objectives ... Maintain compliance with Federal ... regulations pertaining to infection control."

The policy lacked clear language that a Infection Preventionist must be appointed by the governing body to their position and that the appointment must be based on the recommendations of medical staff leadership and nursing leadership as required by CFR 482.42(a).

3. A job description titled, "Infection Preventionist" with a revision date of "September 2018" was reviewed and reflected:
* The job description lacked the requirement that the designated Infection Preventionist must be recommended and appointed to the position by the governing body and that the appointment must be based on the recommendations of medical staff leadership and nursing leadership as required by CFR 482.42(a).

4. A document titled "Job Summary" for Former Employee # 1 titled "Director of Quality/Risk Management" was reviewed and reflected:
* A list of "Secondary Jobs" included "Infection Preventionist" with a status of "Active" and a "Job Start Date" of "06/19/2023".

5. An email dated "November 18, 2024 1:41 PM", the last day of the onsite portion of the survey from the Director of Human Resources to the CCO was reviewed and reflected:
* "[Former Employee # 1] is a PRN Employee and has been so since 10/20/2024 and as such is a current employee of Vibra Specialty Hospital of Portland."

6. A printed email authored by Former Employee # 1 dated "September 3, 2024 8:12 AM" was provided on 11/18/2024, the last day of the survey, and after the IP review. It was reviewed and reflected:
* "Please accept this email as formal notification of my resignation as Director of Quality Management for Vibra. My last day of employment will be Friday September 27, 2024 ... I would like to offer to remain in PRN status for up to four hours per week to support the onboarding of my replacement, through October 25, 2024."
* The email closing signature included the following job titles, "Director of Quality Management and Infection Prevention".
* An unsigned, undated handwritten note at the bottom of the printed email read, "agreed to stay PRN thru 11/30/24".

The hospital provided conflicting information regarding Former Employee # 1's employment status. For example, prior to the IP reviews, the hospital had introduced Former Employee # 1 as a "former employee", refer to Finding 10, opening conference introductions on Day 4 of the onsite survey. It was unclear whether Former Employee # 1 left the hospital employment on "10/25/2024" as stated in the email and it was unclear when Former Employee # 1 "agreed to stay PRN" as the handwritten note was unsigned and undated. Additionally, refer to Finding 11, statement by Former Employee # 1 that they were still employed due to a "glitch" in the HR system.

7. A document titled "Authority Statement" and dated 04/18/2024 was reviewed and reflected:
* "Purpose: To delegate authority and responsibility for infection prevention and control."
* "Policy: It is the policy of Vibra Healthcare that the Infection Control Committee, through its Infectious Disease Physicians and Infection Preventionist, shall have authority to institute surveillance, prevention, control measures, or studies: and shall have the authority to intervene in situations involving infection hazards to patients, personnel, and visitors in the hospital environment."
* "Under normal circumstances, recommendations for such studies or control measures are subject to the review and approval of the Medical Executive Committee."
* "Procedure: The administrator has delegated the administrative authority, responsibility, and accountability of implementing the hospital's established policies and procedures governing infection prevention and control to the Infection Preventionist."
* Three signatures were noted:
- "Chairman, Medical Staff" dated "4/18/2024".
- "Chief Executive Officer" dated "4/18/2024".
- "Infection Preventionist" [Former Employee # 1's signature] dated "4/18/2024".

The "Authority Statement" lacked clear language that the Infection Preventionist was recommended and appointed to the position by the governing body and that the appointment was based on the recommendations of nursing leadership as required by CFR 482.42(a). Additionally, the "Authority Statement" was dated "4/18/2024", approximately 10 months after Former Employee # 1's "Job Start Date" as documented in Finding 4. There was no "Authority Statement" document provided for Employee #2, the current IP.

8.a. The CCO provided a Word document by email on 11/18/2024 at 3:28 PM. The document was undated and titled, "Vibra Healthcare Infection Preventionist Orientation Checklist" for Former Employee # 1. It was reviewed and reflected:
* The first noted date of training was "7-24-23" and the last noted date of training was "8-29-2023".
* There were 9 areas of training and all areas had corresponding columns titled "Methods ... Date ... [and] Signature". The following was noted in each area:
- Infection Control Plan/Risk Assessment; "Methods ... Verbal ... Date ... 7-24-2023 ... Signature ... [blank]"
- Infection Prevention and Control Committee; "Methods ... Verbal ... Date ... 7-24-2023 ... Signature ... [blank]"
- Surveillance; "Methods ... Verbal ... Date ... 8-3-2023 ... 8-10-2023 ... 8-15-2023 ... Signature ... [blank]"
- Reporting; "Methods ... Verbal ... Date ... 7-24-2023 ... Signature ... [blank]"
- Employee Health; "Methods ... Verbal ... Date ...8-22-023 ... Signature ... [blank]"
- Emergency Preparedness; "Methods ... Verbal ... Date ... 8-22-2023 ... Signature ... [blank]"
- Survey Preparedness; "Methods ... Verbal ... Date ... 8-22-2023 ... Signature ... [blank]"
- Resources; "Methods ... Verbal ... Date ... 7-24-2023 ... Signature ... [blank]"
- Miscellaneous; "Methods ... Verbal ... Date ... 8-29-2023 ... Signature ... [blank]"
* "Comments: [Former Employee # 1] has a good knowledge of the IP landscape from serving in several quality positions. The orientation went smoothly and most was learning [sic] how to identify infections through surveillance and reviewing the IP policies that guide Vibra."
* "Signature of Trainer: [Name], DNP, MPH, RN, CIC, FAPIC" There was no date following the trainer's electronic signature and the electronic signature did not contain a digital certificate to denote when the document had been electronically signed.

It was unclear when Former Employee # 1 completed all of the required competencies as the final comment and trainer signature lacked a date, and the word document did not include a certified digital signature that verified when it was originally completed or signed. It was unclear whether each individual competency had been verified as the corresponding signature block in each training area was blank.

8.b. The CCO provided a second document by email on 11/18/2024 at 3:43 PM. The document was undated and titled, "Vibra Healthcare Infection Preventionist Orientation Checklist" for Former Employee # 1. It was reviewed and reflected:
* The first noted date of training was "7-24-23" and the last noted date of training was "8-29-2023".
* There were 9 areas of training and all areas had corresponding columns titled "Methods ... Date ... [and] Signature". The following was noted in each area:
- Infection Control Plan/Risk Assessment; "Methods ... Verbal ... Date ... 7-24-2023 ... Signature ... [Name], DNP, MPH, RN, CIC, FAPIC"
- Infection Prevention and Control Committee; "Methods ... Verbal ... Date ... 7-24-2023 ... Signature ... [Name], DNP, MPH, RN, CIC, FAPIC"
- Surveillance; "Methods ... Verbal ... Date ... 8-3-2023 ... 8-10-2023 ... 8-15-2023 ... Signature ... [Name], DNP, MPH, RN, CIC, FAPIC"
- Reporting; "Methods ... Verbal ... Date ... 7-24-2023 ... Signature ... [Name], DNP, MPH, RN, CIC, FAPIC"
- Employee Health; "Methods ... Verbal ... Date ...8-22-023 ... Signature ... [Name], DNP, MPH, RN, CIC, FAPIC"
- Emergency Preparedness; "Methods ... Verbal ... Date ... 8-22-2023 ... Signature ... [Name], DNP, MPH, RN, CIC, FAPIC"
- Survey Preparedness; "Methods ... Verbal ... Date ... 8-22-2023 ... Signature ... [Name], DNP, MPH, RN, CIC, FAPIC"
- Resources; "Methods ... Verbal ... Date ... 7-24-2023 ... Signature ... [Name], DNP, MPH, RN, CIC, FAPIC"
- Miscellaneous; "Methods ... Verbal ... Date ... 8-29-2023 ... Signature ... [Name], DNP, MPH, RN, CIC, FAPIC"
* "Comments: [Former Employee # 1] has a good knowledge of the IP landscape from serving in several quality positions. The orientation went smoothly and most was learning [sic] how to identify infections through surveillance and reviewing the IP policies that guide Vibra."
* "Signature of Trainer: [Name], DNP, MPH, RN, CIC, FAPIC"

It was unclear when Former Employee # 1 completed all of the required competencies as the final comment and trainer signature lacked a date, and the word document did not include a certified digital signature that verified when it was originally completed or signed as further evidenced by this second document containing signatures that had not been previously provided on the first competency for Former Employee # 1.

8.c. The CCO provided a Word document by email on 11/19/2024 at 11:42 AM. The document was undated and titled, "Vibra Healthcare Infection Preventionist Orientation Checklist" for Employee # 2. It was reviewed and reflected:
* The first noted date of training was "10-5-24" and the last noted date of training was "10-5-2024".
* There were 9 areas of training and all areas had corresponding columns titled "Methods ... Date ... [and] Signature". Three of the 9 areas had been documented as completed as of the last day of the survey, 11/18/2024. The following was noted in each area:
- Infection Control Plan/Risk Assessment; "Methods ... [blank] ... Date ... [blank] ... Signature ... [blank]"
- Infection Prevention and Control Committee; "Methods ... 10-5-2024 [sic] ... Date ... [blank] ... Signature ... [blank]"
- Surveillance; "Methods ... [blank] ... Date ... [blank] ... Signature ... [blank]"
- Reporting; "Methods ... 10-5-2024 [sic] ... Date ... [blank] ... Signature ... [blank]"
- Employee Health; "Methods ... 10-5-2024 [sic] ... Date ...[blank] ... Signature ... [blank]"
- Emergency Preparedness; "Methods ... [blank] ... Date ... [blank] ... Signature ... [blank]"
- Survey Preparedness; "Methods ... [blank] ... Date ... [blank] ... Signature ... [blank]"
- Resources; "Methods ... [blank] ... Date ... [blank] ... Signature ... [blank]"
- Miscellaneous; "Methods ... [blank] ... Date ... [blank] ... Signature ... [blank]"
* "Comments: [Former Employee # 1] [sic] has a good knowledge of the IP landscape from serving in several quality positions. The orientation went smoothly and most was learning how to identify infections through surveillance and reviewing the IP policies that guide Vibra."
* "Signature of Trainer: [Name], DNP, MPH, RN, CIC, FAPIC" There was no date following the trainer's electronic signature and the electronic signature did not contain a digital certificate to denote when the document had been electronically signed.

It was unclear whether Employee # 2 completed any of the required competencies as the final comment referenced Former Employee # 1, the trainer signature lacked a date, and the Word document did not include a certified digital signature that verified when it was originally completed or signed. It was unclear whether each individual competency with a date under the "Method" column had been verified as the corresponding signature block in each completed training area was blank.

9. During an interview with the Infection Prevention department on 11/14/2024, beginning at 1338 with the EH/IP-PD, Employee # 2, they introduced themselves as the current Infection Preventionist with a start date in the position of 10/01/2024. During the interview, the EH/IP-PD was not able to provide information on the hospital's surveillance system for identifying, tracking or monitoring HAIs in accordance with CMS requirements or hospital P&Ps. The review ended in less than 20 minutes at 1356, as the EH/IP-PD was unable to provide requested information regarding the hospital's Infection Prevention program. The review was rescheduled.

10. During the opening conference on 11/18/2034, beginning at 1200, the CEO and the CCO introduced Former Employee # 1 as a former employee who agreed to come in and provide information to the survey team as the current IP was in training. Former Employee # 1 was also described as the previous Quality Director and Infection Preventionist.

11. During a follow up interview with the Infection Prevention department on 11/18/2024, with the CCO, CEO, EH/IP-PD, and Former Employee # 1 beginning at 1330, the following information was provided:
* The CCO confirmed that Employee # 2 had not been appointed by the governing body to the IP position and that Employee #2 had not been recommended to the position by either medical staff leadership or nursing leadership, as described in Finding 7.
* The CCO confirmed that Employee # 2 had been hired into the position in October of 2024 and that Employee # 2 was still in training.
* Former Employee # 1 stated that there was a "glitch with HR" and that they had not been removed from the system after their resignation and therefore they were still employed at Vibra "due to a glitch".
* Information regarding the Infection Prevention program, including Risk Assessments, HAI surveillance, the development and implementation of IP policies and procedures were provided by Former Employee # 1 and the CCO.
* The CCO and Former Employee # 1 stated that Former Employee # 1 had continued as the hospital's Infection Preventionist on a PRN basis. When the surveyor requested clarification as to Former Employee # 1's employment status due to the hospital's introduction as described in Finding 10, the CCO provided the email documented in Finding 6, that Former Employee # 1 continued as a PRN IP.

It was unclear whether the hospital had designated an Infection Preventionist who was qualified through experience and training for the hospital as both Former Employee # 1's and Employee # 2's competencies lacked the trainer's signature in the completed areas of training, refer to Findings 8.a. - 8.c., IP training documents. It was unclear whether Former Employee # 1 continued as the PRN IP after their formal resignation date as the resignation email stated they would only remain PRN until 10/25/2024. The undated note inscribed on the bottom of the printed email was undated and unsigned, and did not provide clear documentation on when Former Employee # 1 had agreed to extend their PRN status, refer to Finding 6, Former Employee # 1's resignation email. Additionally, Former Employee # 1 stated that they remained employed because of a "glitch" and not because of an agreed upon extension of their PRN status.

12. Refer to Tag A- 774, Finding 2, QA minutes (14 of 15 minutes) which lacked documentation that clearly identified that a desginated IP for the hospital was in attendance.

******************************************************

INFECTION CONTROL SURVEILLANCE, PREVENTION

Tag No.: A0750

Based on observations, interview, review of infection control P&Ps, and other documentation, it was determined that the hospital failed to ensure that infection prevention P&Ps had been fully developed and implemented, and provisions for ongoing assessment and evaluation of those put into place. Procedures and processes based on nationally recognized standards to ensure infection prevention such as the prevention of cross-contamination and HAIs, had not been fully developed and enforced in the following areas:
* The hospital's IC Program was not fully developed and implemented to address infection prevention and control issues. Policies were unclear, inconsistent, and were not in accordance with nationally recognized standards.
* The HAI surveillance was not conucted in accordance with the hospital's P&Ps, including the identification, reporting, monitoring and documentation of outbreaks and potential outbreaks associated with its Water Management Program.
* The hospital's Water Management Program was not fully developed and implemented to address infection prevention and control issues. Policies were unclear, inconsistent, and were not in accordance with nationally recognized standards.
* The hospital did not fully implement IC policies to maintain a clean and sanitary environment, including maintaining the separation of clean and dirty patient care items and supplies. Such as:
- Cleaning products, hand hygiene products, and patient care supplies and equipment were expired, unlabeled, had incomplete or illegible labels, or were not maintained in a clean or sanitary manner.
- Food handling and storage was not in accordance with the manufacturers' IFUs or hospital P&Ps to ensure prevention of food-borne illness.
* Single-dose medication vials were not managed in accordance with P&Ps.
* Tracheostomy mask drainage (condensation) bags were not managed in accordance with nationally recognized standards.
* Urinary catheter drainage bags were not managed in accordance with nationally recognized standards.

Further, the Interpretive guidelines reflect that the hospital should know how to recognize and contain infectious disease outbreaks. "An outbreak is the occurrence of more cases than expected in a given area or among a specific group of people over a particular period of time ... In the event of an outbreak of an infectious disease, hospitals should have policies and procedures in place to address the appropriate steps to diagnose and manage cases, implement appropriate precautions, and prevent further transmission of the disease as well as documentation of follow-up activity in response and comply with state and local public health authority requirements for identification, reporting, and containing communicable diseases and outbreaks."

Findings include:

1.a. Regarding the Infection Prevention and Control Program:

1.b. An undated document titled, "Vibra Hospital of Portland Infection Control Risk Assessment 2024" was reviewed and reflected:
* The risk assessment tool contained five columns with the following titles, "Event ... Probability of Occurrence ... Patient Effect ... Preparedness to Address Risk ... Risk Level".
* Directly below were 12 additional columns for scoring and risk ranking. The following scoring criteria were noted:
- Under Probability of Occurrence was: "High (3) ... Med (2) ... Low (1) ... None (0)".
- Under Patient Effect was: "Fatal (3) ... Perm Harm (2) ... Temp Harm (1) ... None (0)".
- Under Preparedness to Address Risk was: "Poor (3) ... Fair (2) ... Good (1)".
* The risk assessment tool contained four areas that were assessed. These were: "Hospital Acquired Infections ... Failure of Prevention Activities ... Environment ... [and] Emergency Management".
* At the bottom of the risk assessment tool was noted, "Risk Assessment will be used to prioritize needed resources/intervention. Ranking score determined by multiplying all column scores. High Risk = 18-27, Medium Risk = 6-12, Low Risk = 0-4".
* Twenty-eight items were listed. Eleven of the 28 items had a score of "0" probability of occurrence, and one item was not scored in three of three columns (Probability of occurrence, Patient Effect, and Preparedness to Address Risk).
* Examples of items scored as zero probability of occurrence included:
- "CRE" - "Probability ... None (0)"; "Patient Effect ... Fatal (3)"; Preparedness ... Good (1)"; "Total Ranking ... 0".
- "Candida Auris" - "Probability ... None (0)"; "Patient Effect ... Fatal (3)"; Preparedness ... Good (1)"; "Total Ranking ... 0".
- "Emerging Pathogens" - "Probability ... None (0)"; "Patient Effect ... None (0)"; Preparedness ... (0) [not scored per described choices: 1, 2, or 3] "; "Total Ranking ... 0".
- "Tuberculosis" - "Probability ... None (0)"; "Patient Effect ... Fatal (3)"; Preparedness ... (0) [not scored per described choices: 1, 2, or 3]"; "Total Ranking ... 0".
* "Legionella and Water Management" - "Probability ... Med (2)"; "Patient Effect ... Fatal (3)"; Preparedness ... Fair (2)"; "Total Ranking ... 12".
* "Water-borne Illness" - "Probability ... [not scored]"; "Patient Effect ... [not scored]"; Preparedness ... [not scored]"; "Total Ranking ... 0".
* "COVID-19" - "Probability ... Med (2)"; "Patient Effect ... Temp Harm (1)"; Preparedness ... Good (1)"; "Total Ranking ... 2".
* There was no completion date indicating when the Risk Assessment had been conducted.
* There was no notation of who had completed the Risk Assessment, or whether it had been reviewed and approved by the IC Committee or the QA Committee.

There was no documentation that the ICC, to whom the "The Medical Executive Committee ... [had delegated] the responsibility of monitoring infection control processes and procedures to the Infection Control Committee ... " had reviewed or provided input on the hospital's IC Risk Assessment as the hospital did not have an ICC. There was no documentation that "The Infection Control Committee ... evaluates, revises and approves the type and scope of surveillance activities. Recommendations for prevention activities will be provided by committee members. The Infection Control Committee oversees all aspects of infection control throughout the hospital." Refer to Finding 1.d., the Infection Control and Prevention Plan P&P. Additionally, it was unclear how "Probability of Occurrence" was determined as Risk Level determinations were inconsistent with the described process for determining those Risk Levels. For example, during an interview with Former Employee # 1, the former IP, on 11/18/2024, Finding 1.g., beginning at 1330, they were asked how the probability of occurrence was determined. Former Employee # 1 stated it was based on identified cases in the hospital's inpatients the previous year and did not consider community incidence rates, contrary to nationally recognized standards for assessing infection risks. This response also contradicted the provided data in the "Annual TB Risk Assessment 2024" where the community incidence rates of TB were considered in the annual TB Risk Assessment (TBRA), refer to the hospital's TBRA below. Additionally, the TBRA data contradicted the TB data provided in the IC Risk Assessment. For instance, the TBRA posed the following question, "Are patients with suspected or confirmed TB disease encountered in your setting ... ?" The hospital responded, "Yes", and noted "1" suspected TB case. In contrast, the IC Risk Assessment scored the "Probability" of TB as "None (0)", indicating no cases or suspected cases were encountered the previous year according to Former Employee #1's response above. Other unclear data included Legionella, a waterborne illness. Legionella was determined to be the highest risk level and the "Probability" was scored as "Med (2)" while "Water-borne Illness" was scored as: "Probability ... [not scored]"; "Patient Effect ... [not scored]"; Preparedness ... [not scored]"; "Total Ranking ... 0". Also, in a review of 15 of 15 QA Committee meeting minutes, the forum identified by the hospital for reporting IC concerns, and HAI data "monthly", there were no noted cases of Legionella, TB or suspected TB, all reportable diseases in the State of Oregon, refer to Finding 1.e. below, mandatory reportable diseases and conditions for the State of Oregon. Therefore, it was unclear how probability scores of "Med (2)" for Legionella and TB, were determined when identified inpatient cases were not reported in the QA meetings minutes in accordance with the hospital's stated process. Refer to Findings in Tag A-774, QA meeting minutes.

1.c. An undated document titled, "Annual TB Risk Assessment 2024" was reviewed and reflected:
* "1. Incidence of TB ... What is the incidence of TB in your community (county or region served by the health-care setting) ... Community rate 0 [zero] (Multnomah county)"
* "Are patients with suspected or confirmed TB disease encountered in your setting ... If yes, how many patients with suspected and confirmed TB disease are treated in your health-care setting in 1 year ... Year 2023, 0 patients ... 1 year ago ... suspected 1".
* There was no completion date indicating when the Risk Assessment had been conducted. It was unclear whether the "Year 2023" was calendar year, fiscal year, or what 12 month period was used for the yearly risk assessment.
* There was no notation as to who had completed the Risk Assessment, whether it had been reviewed and approved by the ICC, or by the QAC.

The data presented in the Annual TBRA for 2024 was incorrect and noted a community TB incidence rate of zero. However, the Multnomah County Oregon published incidence rate of TB for 2023 was 3.1 as of March 28, 2024; last accessed 12/05/2024 from the OHA website "Communicable Disease ... Tuberculosis ... Documents ... commriskassess.pdf". The published incidence rate of TB for Multnomah County in 2022 was 3.9; last accessed from the OHA website on 12/05/2024. In either year, the incidence rate for TB in Multnomah County Oregon was greater than "0". Additionally, there was no documentation that the ICC, to whom the "The Medical Executive Committee ... [had delegated] the responsibility of monitoring infection control processes and procedures ... " had reviewed or provided input on the hospital's Annual TBRA as the hospital did not have an ICC. There was no documentation that "The Infection Control Committee [who] ... evaluates, revises and approves the type and scope of surveillance activities ... " had evaluated the risk assessment or provided "Recommendations for prevention activities ..." Refer to the Infection Control and Prevention P&P below.

1.d. A policy titled, "Infection Control & Prevention Plan" dated last reviewed "4/24" was reviewed and reflected:
* "Scope Organization Wide".
* "Reference TJC IC".
* "Statement of Purpose ... Infection Prevention and Control practices and interventions will be based on current evidence-based practice literature relevant to the patient population we serve ... The Infection Prevention Program will comply with Federal, State [sic] and Local regulatory laws."
* "Vibra Healthcare Identified Goals and Objectives ... All hospitals will utilize National Healthcare Safety Network criteria for defining an infection ... Maintain compliance with Federal, State [sic] and Local regulations pertaining to infection control."
* "Hospital Identified Goals and Objectives ... Increase hand hygiene compliance to above 90% ... Report hand hygiene rates monthly to ICC".
* "The Medical Executive Committee is responsible for overseeing the Infection Control Program and delegates the responsibility of monitoring infection control processes and procedures to the Infection Control Committee."
* "Infection Control data is shared with the Quality Assurance and Performance Improvement Committee monthly."
* "The Infection Control Committee selects, designs, evaluates, revises and approves the type and scope of surveillance activities. Recommendations for prevention activities will be provided by committee members. The Infection Control Committee oversees all aspects of infection control throughout the hospital.
* "The Infection Control Physician will serve as an advisor and a resource for the Infection Preventionist. This individual will have training and/or expertise in infection control. This individual will make recommendations for improvement and may advise on policies and procedures.
* "Infection Preventionist ... This person has training in infection surveillance, prevention and control ... The Infection Preventionist is responsible for coordinating activity within the Infection Control Committee and reporting findings to the Quality Assurance and Performance Improvement Committee."
* "Leadership and Responsibility ... the Infection Preventionist assumes the responsibility of managing and carrying out the infection surveillance, prevention and control functions within the hospital. This person has training in infection surveillance, prevention and control ... The Infection Preventionist is responsible for coordinating activity within the Infection Control Committee and reporting findings to the Quality Assurance and Performance Improvement Committee."
* "The Infection Preventionist will conduct outbreak investigations whenever appropriate. See Outbreak Investigation Policy for procedure utilized for an outbreak investigation."
* "The Infection Preventionist will be responsible for reviewing data from surveillance, audits and information from other sources to implement evidence-based and sound interventions with recommendation from the infection control committee."
* "Policies and Procedures ... will be in compliance with Federal, State [sic] and Local laws applicable to infection prevention.
* "Reporting and Communication ... Information about infections are reported both internally and to public health agencies (per state and local requirements) ... Infection Control Committee shall be held at least quarterly. Minutes will be recorded by the Infection Preventionist and/or designee. Findings, quality activities, performance improve [sic] activities, and follow up evaluations will be reviewed by the Infection Control Committee, Quality Assurance and Performance Improvement Committee, Medical Executive Committee and Governing Board."

1.e. The P&P titled, "Outbreak Investigation" dated last reviewed "01/2023" was reviewed and reflected:
* "This policy provides the steps for outbreak investigation".
* "An outbreak is an increase in the incidence of a disease, complication or event above the background rate ... one case of an unusual disease ... may also constitute an outbreak."
* "The Infection Preventionist in coordination with the Infection Control Committee and/or Infection Control Chair will investigate suspected outbreaks ..."
* "Notify leadership of the suspected outbreak".
* "Communicate finding to the Chair of the Infection Control Committee ... and all pertinent staff members regarding the cause or suspected cause of the outbreak".
* "When appropriate, consult with Chair of Infection Control Committee ..."
* "Collaborate and communicate outbreak to health department. Report findings of the investigation to the health department, Infection Control Committee and leadership".
* "Related Documents: Infection Prevention Plan".

1.f. A document titled "Authority Statement" dated 04/18/2024 was reviewed and reflected:
* "Purpose: To delegate authority and responsibility for infection prevention and control."
* "It is the policy of Vibra Healthcare that the Infection Control Committee, through its Infectious Disease Physicians and Infection Preventionist, shall have authority to institute surveillance, prevention, control measures, or studies; and shall have the authority to intervene in situations involving infection hazards ... in the hospital environment."
* "Procedure: The administrator has delegated the administrative authority, responsibility, and accountability of implementing the hospital's established policies and procedures governing infection prevention and control to the Infection Preventionist. In an emergency ... the Chairman of the Infection Control Committee and Infection Preventionist shall have the authority to intervene and institute appropriate control measures."
* "It shall be the Infection Preventionist's responsibility to determine if proper prevention and control measures are being observed according to current regulatory guidelines and hospital policy governing infection control issues as well as to identify, investigate, and control outbreaks of infectious diseases with the hospital."
* The statement was signed and dated by the "Chairman, Medical Staff ... Chief Executive Officer ... [and the] Infection Preventionist [Former Employee # 2]".
* There was no documentation that nursing leadership had approved the appointment of the infection preventionist as required by CMS.

The hospital failed to fully implement its Infection Control and Prevention Plan P&P. The hospital did not have an ICC in accordance with its P&P. Refer to the Findings in Tag A-774., no documentation of ICC meetings, and CCO confirmation that ICC meetings were not being held as described in the ICP Plan P&P. Additionally, there was no IC Physician in accordance with the ICP Plan. Refer to the Finding in Tag A-748, the hospital's organizational chart. The hospital provided incomplete and inconsistent training documentation for Former Employee #1 (the former IP) and Employee #2, the hospital's current IP. Additionally, see Employee #2's training documentation which did not reflect the training requirements as stated in the ICP Plan P&P, "This person has training in infection surveillance, prevention and control". Refer to Findings in Tag A-748, IP designation, inconsistent competency documentation, and lack of training in IP surveillance for the current IP (EH/IP-PD), Employee #2 evidenced by the IP program review on 11/14/2024. Employee #2, was unable to provide information on the hospital's surveillance processes, approximately one month and two weeks after assuming the IP position. Further, suspected outbreaks were not reported to either the QAC or State Health Authorities in accordance with the hospital's ICP Plan, Outbreak Investigation, or the IP Surveillance P&Ps. Refer to the hospital's P&Ps above, the interviews with Former Employee #1 and the CCO, documented outbreak information, and also Findings in Tag A-774, IP and QA meeting minutes for 2023. The IP Annual RA and the annual TBRA, upon which the ICP was based, were incomplete, inconsistent, and did not adhere to nationally recognized standards for risk assessments. It was unclear whether current and up-to-date surveillance data was used to develop the ICP in accordance with the hospital's P&Ps, refer to the hospital's Risk Assessments above which reflected inconsistent data in scored IP risks, and refer to Tag A-747, Finding 1, the hospital's IP surveillance P&P that stated, "data should be used to plan infection prevention and control activities".

1.g. During a follow up interview with the Infection Prevention department on 11/18/2024, with the CCO, CEO, EH/IP-PD (Employee #2), and Former Employee # 1 beginning at 1330, the following information was provided:
* The CCO confirmed that Employee # 2 had been hired into the IP position October of 2024, and that Employee # 2 was still in training as the hospital's designated IP.
* The CCO confirmed that Former Employee # 1 had been the designated IP for the hospital and was no longer working full time since resigning in September, 2024.
* The CCO confirmed that neither Former Employee #1 nor Employee # 2 had been appointed by the governing body to their IP position.
* The CCO confirmed neither Former Employee #1 nor Employee #2 had been recommended by nursing leadership to their positions as required by CMS, and that Employee # 2 had not been recommended to their position by medical leadership. The CCO provided a document signed by the Chairman of the MEC, the CEO, and Former Employee # 1 granting "administrative authority, responsibility, and accountability" of the ICP to Former Employee # 1 on 04/18/2024, approximately 10 months after they assumed the IP position on 06/19/2023. Refer to Finding 1.f., VSH's "Authority Statement" letter. The CCO confirmed there was no similar letter for the current IP.
* The CCO and Former Employee #1 confirmed that the hospital did not have an IC Committee in accordance with the hospital's P&P, refer to Finding 1.d., the Infection Control and Prevention Plan.
* The CCO and Former Employee # 1 confirmed that the hospital did not have an Infection Control Physician in accordance with the hospital's P&P, refer to Finding 1.d., the Infection Control and Prevention Plan.
* Former Employee # 1 confirmed that a suspected COVID-19 outbreak had occurred July 2023. Former Employee # 1 confirmed the outbreak was reported to the state health department on August 18, 2023, and that a case log form was completed at the request of the State Health Department.
* Former Employee # 1 stated that they had completed the Annual IC Risk Assessment and that the "Probability of Occurrence" scores were based on the number of admitted patients who had been identified with those infections the year prior.

2.a. Regarding the Water Management Program:

2.b. An electronic document titled, "Portland Risk Assessment Plan Water" was provided in response to a request for the Risk Assessment for the WMP. It was reviewed and reflected:
* A second title was noted on page one of the document, "Risk management plan for Legionella Control in the operation and maintenance of the water systems of Vibra Hospital of Portland."
* "Revision history ... Original ... 2/1/21 ... Management Team Change ... 1-17-24 ... Review/Change ... 1-17-24" A column for initials was provided next to each date, but all three dates lacked accompanying initials.
* "Risk management team members" included: "MD ... ICP ... DQM ... COO ... LMT ... DPO..." The "MD" had the same name as the "ICP" however, the ICP had not been introduced as an MD during IP program interviews.
* Page four contained the same type of diagram as described in the WMP in Finding 2.c. This diagram, however, contained information for three hospital floors and described "Receiving ... Cold Water Distribution ... Heating ... Hot Water Distribution [and] ... Waste" sources, and was titled, "Figure 1 ... Schematic of Vibra Hospital of Portland water delivery system".
* "System details ... Incoming water is supplied to a (4) water heater of 100 gallon capacity, set at 125 degrees F ..."
* "Inventory of system components ... 5 water heaters ... 2 east penthouse ... 2 center penthouse ... 1 shop area".
* "Pipework ... 0 dead legs - use 2 recirculating pumps".
* "Hazard identification ... Dead legs and capped pipes ... Outlets ... Unused outlets ... Outlets that hold water after use (e.g. shower heads or hoses) ..."
* "Risk assessment ... Hot water system ... Water temperature too low ... Medium [risk] ... Measure temperature weekly and adjust if too low ... Pipework ... Low flow in areas ... High [risk] ... Weekly flushing of water in areas of low use".
* Control measures listed included weekly flushing of pipes, maintenance of equipment and inspection of water heaters.
* Operational monitoring included monthly checks of water temperature with noted parameters of "Temperatures between 105 and 120." Corrective action noted was "Increase temperature of water heater". There were no other items listed under operational monitoring.
* "Incident response key personnel and their responsibilities ... Water sampling/system investigation [DPO] ... Coordinating system decontamination ... [DPO] ... High risk patient identification ... IP/CCO ... Implementation of high risk patient protection procedures ... IP/CCO ... Media liaison ... CEO/Director of Business Development."
* A table titled, "Incident response procedures" contained three columns, "Incident ... Responses ... Procedure name" and five actions followed by the response and procedure:
- Isolated Legionella species detection ... Water sampling or system evaluation ... Undertaking a Legionella colonisation [sic] investigation
- Isolated Legionella species detection ... Localised [sic] partial system decontamination ... Assess and undertake appropriate local partial system decontamination
- Single confirmed Legionnaires' disease case linked to facility ... Case activity investigation ... Assess potential case exposures during incubation period
- Single confirmed Legionnaires' disease case linked to facility ... High risk patient identification ... Undertaking a high risk patient identification
- Single confirmed Legionnaires' disease case linked to facility ... Implementation of high risk patient protection procedures ... Protecting identified high risk patients"
* "A full review of the plan will be conducted on an annual basis. The plan will be reviewed more frequently as a result of: Change in infrastructure ... Detection of Legionella ... New staff roles ... Changes in legislation or standards for accreditation."

It was unclear whether this document was meant to be the hospital's WMP or the Risk Assessment upon which the WMP was based. For example, although the document contained a diagram of general, potentially hazardous areas, areas with identified concerns were not called out, such as patient care rooms with consistently low water temperatures, refer to Finding 3.f., the hospital's water temperature check log. The "Risk assessment" table listed generalized items and systems, and did not identify specific locations, high-risk patient areas, or water sources within the patient care environment that had been identified, and assessed as "High", "Moderate" or "Low" risk levels. The risk assessment did not consider the hospital's current preparedness in response to a waterborne pathogen in accordance with nationally recognized guidelines for risk assessments. Information in the risk assessment was inconsistent. For example, "System details" noted "4" water heaters, yet the "Inventory of system components" noted "5" water heaters. Additionally, under "Pipework" zero dead legs were noted. However, during a tour of the facilities, a capped pipe, unused shower rooms and a filled-in drain were noted. According to the CDC website, Infection Control, Appendix A: Glossary of Terms, last accessed 12/13/2024, dead legs were defined as: "Areas in the water system where water stagnates. A dead leg is a pipe or spur, leading from the water recirculating system to an outlet that is used infrequently, resulting in inadequate flow of water from the recirculating system to the outlet. This inadequate flow reduces the perfusion of heat or chlorine into this part of the water distribution system, thereby adversely affecting the disinfection of the water system in that area." Refer to Finding 4.d., observations during unit tours where dead legs were observed. It was unclear whether the plan had been reviewed annually as stated as no review dates were documented for 2022, or 2023.

2.c. A document titled, "Water Management Plan" with an "Effective Date" of "1/2024" and a review date of "1/2024" was reviewed and reflected:
* "Plan ... The processes outlined in this plan are designed to develop, implement, and evaluate a Legionella Water Management Program for the hospital."
* "The goals of the plan include, but are not limited to:
- Identify the elements of a Water Management Program.
- Describe the individual hospitals [sic] water systems using text and flow diagrams.
- Identify areas where Legionella could grow and spread ...
- Decide where control measures should be applied.
- Decide how to monitor those control measures.
- Establish processes of intervention when control limits are not met.
- Measure, monitor, and report the plan effectiveness to identify key problems, failures, and user errors that require attention and action.
- Identify and investigate any case of Legionella found in the hospital.
- Conduct a risk assessment if renovation or change to water supply system, or the control measures are found to be ineffective.
- Conduct an annual review of the policy..."
* "Describe the hospital's water systems."
* "The Facilities Department with the input of the Water Management Program team, have developed a flow chart on the water distribution to the different areas of the hospital. See Sample".
* There was a text box on page two of the WMP that read "SAMPLE-Create one for your building".
* On page three of the WMP was a flow chart depicting the water distribution in the hospital. The diagram contained five areas that included "Receiving ... Cold Water Distribution ... Heating ... Hot Water Distribution ... Waste". The diagram included information for floors "B-11", "Floors 2,4,6,8,10", and "Kitchen Appliances Basement".
* "Risk prone areas have been identified on the flow chart such as: dead-end pipes, ice machines, hot water heaters, closed patient room areas, anywhere that water is allowed to sit dormant. Sample below".
* On page four of the WMP was a second flow chart with the same information as the flow chart on page three, but with symbols next to each identified area. Next to the flow chart was a legend that included: "Temperature ... Stagnation ... No Disinfectant ... Conditions for Bacteria Spread ... Special Considerations ... External Hazards ...".
* "Based on the risk assessment, prevention and control measures have been developed."
* "Examples of prevention and control measures include but are not limited to; run water in certain areas, flush toilets, monitor pump functioning, monitor temperatures, drain water heaters and disinfectant levels."
* On page five of the WMP was a third flow chart with the same information as the flow chart on pages three and four, but with different symbols next to each identified area. Under the flow chart was a legend that included: "Backflow Preventor ... Water Flow ... Recirculating Return Flow ... Water Process ... Visual Inspection ... Check Disinfectant Levels ... Check Temperature ..." and monitoring recommendations.
* "The Director of Facilities Management or designee will monitor to ensure weekly prevention and control measures are implemented.
* "Identify and investigate any case of Legionella found in the hospital through the infection prevention processes."

The WMP was not fully developed and lacked a water flow diagram that was specific to VSH. For example, the diagrams noted floors "B-11", however, the facility did not have 11 floors, and therefore the document did not "Describe the individual hospitals [sic] water systems using text and flow diagrams ... Identify areas where Legionella could grow and spread ... Decide where control measures should be applied", nor where "Risk prone areas" were located in accordance with the WMP. The WMP stated that prevention and control measures included "run water in certain areas", however, those "certain areas" were not described or listed. Additionally, it was unclear when the WMP had first been implemented, or whether it had been reviewed annually as described. For example, the effective date was "1/2024", the same date as the review date, and no review dates were documented for 2022, or 2023. Furthermore, notes from the 04/18/2024 QA meeting stated that no "Annual Plans" had been reviewed from 2023 and then listed several 2023 Annual Plans to be reviewed. The list did not include the hospital's WMP. Refer to Tag A-774, Finding 2, QA meeting minutes.

3.a. Regarding HAI surveillance:

3.b. During an interview with the Infection Prevention department on 11/14/2024, beginning at 1338 with the EH/IP-PD, Employee # 2, they introduced themselves as the current IP with a start date in the position as of 10/01/2024. During the interview, the EH/IP-PD was not able to provide information on the hospital's surveillance system for identifying, tracking or monitoring HAIs in accordance with CMS requirements or hospital P&Ps. The review ended in less than 20 minutes at 1356, as the EH/IP-PD was unable to provide requested information regarding the hospital's IPC program and surveillance. The review was rescheduled.

3.c. During a follow up interview with the IPC department on 11/18/2024, beginning at 1330, Former Employee # 1 described the hospital's surveillance system and also stated that a "Covid" respiratory outbreak was identified "July 2023" that had been reported to the State Health Authority. The surveyor requested a copy of the outbreak investigation along with documentation of the date the outbreak had been reported to the health departmen

IC PROFESSIONAL RESPONSIBILITIES POLICIES

Tag No.: A0772

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Based on observation, interview and review of IP P&Ps, it was determined that the hospital failed to fully develop and implement P&Ps that adhered to nationally recognized IP guidelines in the following areas:
* The development and implementation of an Infection Prevention and Control Program that included:
- a designated IP who had specialized training in infection prevention and control;
- an annual risk assessment that thoroughly identified hospital-wide risks, including community-specific risks;
- P&Ps specific to the hospital and state in which the hospital was located;
* The development and implementation of a Water Management program that included an annual risk assessment that thoroughly identified hospital-wide risks and ranked those risks according to nationally recognized standards.
* The development and implementation of P&Ps for:
- hospital HAI surveillance;
- the maintenance and storage of patient care supplies;
- maintenance and storage of patient food;
- care and maintenance of urinary catheters;
- care and maintenance of respiratory equipment; and
- maintenance of a clean and sanitary patient care environment.

Findings include:

1. Refer to the Findings in Tag A-747, CoP 482.42, Infection Prevention and Control, IP program P&P that reference regulatory requirements for a state other than the state in which the hospital was located.

2. Refer to Findings in Tag A-748, the hospital's failure to designate a trained IP who was responsible for the hospital's IP program.

3. Refer to Findings in Tag A-750, the hospital's failure to fully develop and implement IP Program and Water Management Program P&Ps for HAI surveillance, or for maintaining a clean and sanitary environment.

4. Refer to Findings in Tag A-774, the hospital's failure to fully develop and implement IP P&Ps that ensured IP activities were consistently communicated to and and that IP collaborated with the hospital's QAPI program.

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IC PROFESSIONAL COMMUNICATION QAPI

Tag No.: A0774

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Based on interview, review of IP policies and procedures, QA Committee meeting minutes, and other documentation, it was determined that the hospital failed to ensure a designated Infection Preventionist consistently collaborated and apprised the hospital's QAPI program of its surveillance activities including notification of mandatory disease reporting and IP interventions based on collected data and emerging issues.
* The hospital failed to ensure that it clearly documented IP program representation at its QAPI meetings, the forum identified by the hospital as the replacement meeting for the Infection Control Committee.
* The hospital failed to ensure that IP program information and data was shared monthly at the QAPI meetings in accordance with hospital policy.
* Mandatory disease reporting and emerging infectious issues, such as outbreaks, and IP response, were not reported to the QAPI committee in accordance with hospital policy.

Findings include:

1. An email dated 11/18/2024 1:27 PM from the CCO contained an untitled, undated document with the following information:
* "No ICC was held in 2023".
* "Infection Control Committee Dates 2024 ... Meets Quarterly and as needed".
* "Q1: Not held ... Q2: April 11, to review annual plan-contract expired for ID; deferred, will hold in May ... Q3: August 8 ... Q4: November 10"
* Requested ICC meeting minutes were not provided.
* A requested ICC charter was not provided.

The dates provided for quarter three did not coincide with the QA Committee meeting dates. It was unclear whether an ICC meeting was held in August 2024 as both the CCO and Former Employee # 1 stated that the ICC was rolled into the QA Committee meeting. Refer to Finding 3, IC department interview. It was unclear when, or how often IC surveillance data was reported or shared with the hospital's Quality Assurance program.

2. Fifteen QAPI committee meeting minutes from February 16, 2023 through September 18, 2024 were reviewed and reflected:
* 02/16/2024 - The meeting attendance roster included the names and titles of the attendees. IP data was presented. No reported cases of TB, suspected TB, or Legionella. No data reflecting mandatory disease reporting to the state health authorities had occurred.
* 03/23/2023 - The meeting attendance roster included the names and titles of the attendees. The IP was not clearly identified and no IP data was presented. No reported cases of TB, suspected TB, or Legionella. No data reflecting mandatory disease reporting to the state health authorities had occurred.
* 04/20/2023 - The meeting attendance roster included the names and titles of the attendees. The IP was not clearly identified and no IP data was presented. No reported cases of TB, suspected TB, or Legionella. No data reflecting mandatory disease reporting to the state health authorities had occurred.
* 06/15/2023 - The meeting attendance roster included the names and titles of the attendees. The IP was not clearly identified. IP data was presented. No reported cases of TB, suspected TB, or Legionella. No data reflecting mandatory disease reporting to the state health authorities had occurred.
* 07/20/2023 - The meeting attendance roster was blank and no attendees were listed. The IP was not clearly identified and no IP data was presented. A discussion of Central Lines was noted. The minutes reflected that a new IP was hired. No reported cases of TB, suspected TB, or Legionella. No data reflecting mandatory disease reporting to the state health authorities had occurred.
* 10/19/2023 - Titles of attendees were not noted on the meeting attendance roster. The IP was not clearly identified and no IP data was presented. No reported cases of TB, suspected TB, or Legionella. No data reflecting mandatory disease reporting to the state health authorities had occurred.
* 11/16/2023 - Titles of attendees were not noted on the meeting attendance roster. The IP was not clearly identified and no IP data was presented. No reported cases of TB, suspected TB, or Legionella. No data reflecting mandatory disease reporting to the state health authorities had occurred.
* 01/18/2024 - The meeting attendance roster included the names and titles of the attendees. The IP was clearly identified and IP data was presented. Notes regarding the review of Annual Plans stated, "Complete 2023 Annual Evaluations and 2024 Annual Plans ASAP."
* 03/20/2024 - Titles of attendees were not noted on the meeting attendance roster. The IP was not clearly identified and no IP data was presented.
* 04/18/2024 - Titles of attendees were not noted on the meeting attendance roster. The IP was not clearly identified and no IP plan was presented. Notes regarding the review of Annual Plans stated, "Spoke to [POD] and we did not have any EOC plans for 2024. It does not appear that we had any plans for 2023. [Former Employee # 1] found all of the 2023 draft plans in [DQ]'s files. [They] ... forwarded them on to [POD]." Also noted were "Evaluation of 2023 plans:
- PI Plan
- IP plan(s)
- Risk Management Plan
- Employee Health Plan
- Education Plan"
* 05/23/2024 - Titles of attendees were not noted on the meeting attendance roster. The IP was not clearly identified and no IP data was presented.
* 06/20/2024 - Titles of attendees were not noted on the meeting attendance roster. The IP was not clearly identified. IP data was presented.
* 07/18/2024 - Titles of attendees were not noted on the meeting attendance roster. The IP was not clearly identified. IP data was presented.
* 08/22/2024 - Titles of attendees were not noted on the meeting attendance roster. The IP was not clearly identified. IP data was presented, however, that data did not include a respiratory outbreak that had been reported to the state health authority. A bullet point under the section titled "State Reportable Events" read "None". No reported cases of TB, suspected TB, or Legionella.
* 09/18/2024 - Titles of attendees were not noted on the meeting attendance roster. The IP was not clearly identified. IP data was presented, however, that data did not include a respiratory outbreak that had been reported to the state health authority. No reported cases of TB, suspected TB, or Legionella.

Presentation of IP data was not reflected in six of 15 meeting minutes, and no IP data was presented in quarters three or four of 2023, therefore it was unclear when, or how often IC surveillance data was reported or shared with the hospital's Quality Assurance program. The minutes reflected that IC program data was not reported monthly as stated in policy, refer to the Findings in Tag A-750, the Infection Prevention and Control Plan. Although an outbreak had been identified July in 2023, the IP department's follow up investigation, mitigation, and state mandated reporting activities were not noted in QA meeting minutes following the outbreak, refer to Finding 3, CCO and Former Employee # 1 interview confirming the occurrence of an outbreak and report to the state health authorities. Refer also to Finding 4 below, CCO email confirmation that an outbreak had been reported to the state health authorities.

3. During a follow up interview with the Infection Prevention department on 11/18/2024, with the CCO, CEO, EH/IP-PD, and Former Employee # 1 beginning at 1330, the following information was provided:
* The CCO confirmed that the hospital did not have an IC Committee, although the IC Plan stated, "Infection Control Committee shall be held at least quarterly."
* The CCO and Former Employee # 1 stated that the hospital's Infection Control data was shared with the Quality Assurance Committee at least quarterly.
* Former Employee # 1 stated that a COVID outbreak had occurred in July 2023 and that they thought that the outbreak had been reported to the state August 18, 2023. The CCO stated that masking recommendations due to the outbreak had been communicated to others in the hospital in Safety huddle.

It was unclear when, or how often IC surveillance data, or emerging infectious issues were reported or shared with the hospital's Quality Assurance program as there was no IC Committee to oversee "all aspects of infection control throughout the hospital". Additionally, the IC plan stated that the "Medical Executive Committee is responsible for overseeing the Infection Control Program and delegates the responsibility of monitoring infection control processes and procedures to the Infection Control Committee." Without an IC Committee it was unclear who, other than the designated IP, provided recommendations to "implement evidence-based and sound interventions" on surveillance data or emerging infectious issues as described in the IC Plan, refer to Findings in Tag A-750, the IP Program P&Ps. It was unclear whether collaboration between the QAPI program and the IC program was occurring as required by CMS. Although documentation was requested on the outbreak investigation and reporting date, the hospital was not able to provide an exact date or completed outbreak investigation documentation. Refer to Finding 4 below and Findings in Tag A-750, the outbreak investigation documentation.

4. An email from the CCO on 11/20/2024 at 9:42 AM read, "Here is the email [from OHA] where we reported [The outbreak]." The state Acute and Communicable Disease Prevention program email read, "I ... see the July 2023 OB ...". There were no other dates provided such as the date of the report or when the outbreak was declared over.

5. A follow up interview conducted via email with the CCO on 11/21/2024 at 10:08 AM, the CCO further confirmed Findings 1 and 3. The CCO was asked, "We were provided a schedule of IPC meetings (attached). Our understanding is that Vibra has no IPC Committee, no IPC Charter and that the IPC Committee was rolled into Quality meetings. Does the attached schedule primarily describe when IPC issues were reported in the Quality meetings or were there other IPC activities that occurred in those meetings?" In response, the CCO stated, "We have not had any separate meetings but will [sic] changing that. It is best practice to have it separate."

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IC PROFESSIONAL ADHERENCE TO POLICIES

Tag No.: A0776

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Based on observation, interview, review of medical record documentation for 2 of 2 patients reviewed for IP monitoring and evaluation of patient infection needs and risks (Patients 8 and 9), review of P&Ps, and review of the IP Job description, it was determined the hospital failed to ensure the IP monitored and evaluated patients' IP infection needs and risks and collaborated with nursing and the other disciplines to ensure hospital IP P&Ps were enforced in the provision of care to the hospital's medically complex and vulnerable patients.

Findings include:

1. The "Job Description and Competencies Infection Preventionist" dated as revised "September 2018" was reviewed. It included the following IP responsibilities and duties: "... Monitors infection control practices and procedures throughout the facility to ensure all personnel and medical staff are compliant ... implements infection control policies and procedures ... Provides ... coaching on infection control practices and policies to all employees and medical staff ... Demonstrates knowledge and skills necessary to provide care appropriate to the patient population experiencing medically complex conditions, general medical-surgical conditions with rehabilitation and wound care needs ... Additional Responsibilities ... responds to needs of patients by complying with hospital policies ... Routinely shares professional knowledge with staff, managers, and hospital personnel. Attend and participate in facility meetings ... Enters or records data timely and accurately ... participates in processes to measure effectiveness, efficiency, and service ..."

2.a. Documentation of the IP's participation in IDT conferences for Patient 8, and their evaluation of the patient's infection control needs and infection risks, was unclear and incomplete. For example:
* "Interdisciplinary Team Conference Form" documentation for "Date of Team Conference: 12/06/2023" lacked evidence that Patient 8's antibiotic use and infection risks were evaluated. The "Infection Control" section of the conference form was completely blank. Although the patient had numerous infection risks that included recent pneumonia for which antibiotics were given in the facility through 12/06/2023, aspiration precautions, a tracheostomy, a PEG feeding tube, a PICC line, unhealed wounds, surgical incision with exposed wires from a fractured upper extremity, incontinence, and tooth loss and bleeding from the mouth, the IP did not complete the "Infection Control" evaluation which included such as "Patient Status/Needs: Infection Control" and "Infection Control Goals/Plan of Care/Actions" to ensure coordination of Infection Control interventions with the other disciplines.
* "Interdisciplinary Team Conference Form" documentation for "Date of Team Conference: 12/13/2023" lacked evidence that Patient 8's Infection Control problems and needs were evaluated. The "Infection Control" section of the conference form was completely blank as for the prior conference. Although the "Wound Care" section of the conference form reflected: "Surgical site(s): 2" and the infection risks previously identified continued to exist, the IP did not complete the "Infection Control" evaluation or participate in the conference.
* "Interdisciplinary Team Conference Form" documentation for "Date of Team Conference: 12/27/2023" reflected that the IP was an "Attendee" at the conference. However, the only entry under the "Infection Control" section of the conference form was "Lines & Tubes: PICC" and "No infection issues." There were no goals and no comments. The patient's risks related to recent hx of pneumonia, PEG tube, aspiration risk secondary to tube feeding and PO diet including thin liquids, incontinence of bowel and bladder and lack of provision of incontinence care and bathing, and continued wound care, as examples, were not identified as infection concerns.
* The IDT conference documentation for 01/31/2024 and 02/07/2024 reflected the IP was in attendance and the "Infection Control" section for both conferences reflected only "No Issues." However, the patient's infection risks continued, including at that time the medical record reflected the patient exhibited behaviors that included the smearing of feces on themselves. Further, during interview with the CMD on 11/14/2024 beginning at 1400 they stated the patient's behaviors also included "eating" their feces and feces soiled chux.
* Although the patient's infection risks remained throughout the hospitalization, the IP did not participate and did not complete the "Infection Control" section of the IDT conferences for those conducted on 12/20/2023, 01/03/2024, 01/10/2024, 01/17/2024, 01/24/2024, 02/21/2024, 02/28/2024, and 03/06/2024.
* There was no other documentation by the IP in the patient's record than those minimal references identified above in the 12/27/2023, 01/31/2024, and 02/07/2024 IDT conferences.

2.b. For Patient 8 refer to Tag A-395 for the detailed findings related to the patient's problems and needs.

3.a. Documentation of the IP's participation in IDT conferences for Patient 9, and their evaluation of the patient's infection control needs and infection risks, was unclear and incomplete. For example:
* "Interdisciplinary Team Conference" documentation reflected "Date of Team Conference: 01/31/2024," the date of the patient's discharge to the ICU in an acute hospital, lacked evidence that the IP had evaluated Patient 9's antibiotic use and infection problems and needs, and multiple other infection risks. The "Infection Control" section of the IDT conference form reflected only "Isolation" and "Other." A comment next to "Other" was "CRE sputum, hx." In the "Additional Infection Control Comments:" was written "Educated [spouse] upon admission about droplet precautions, wearing a gown while in room and masking." There was no other documentation by the IP in the patient's record. There was no reference to the patient's infection control problems that included an extensive Stage IV sacral pressure ulcer that worsened during the hospital stay, osteomyelitis, positive cultures for Enterobacter cloacae, two IV antibiotics running simultaneously, wound cultures that had been taken, contact isolation precautions, multiple IV sites, ventilator, tracheostomy, tube feeding and aspiration risk.
* On 01/31/2024 at 1041 an MD signed a "Provider Progress Note" that reflected the patient "has fever, more confusion and Delirium. Sacral decub ulcer examined, [signs of] exudative discharge with concern of worsening of decub ulcer and likely worsening of superimposed infection and Osteomyelitis ... patient to be transferred to [an acute hospital's Intensive Care Unit] for further work up ... Sacral decubitus ulcer with osteomyelitis. Cultures positive for Enterobacter cloacae, CRE ... [Patient's] condition remains Critical."

3.b. For Patient 9 refer to Tag A-395 for the detailed findings related to the patient's problems and needs.

44104

4. Refer to Findings in Tag A-750, the hospital's and the IP's failure to audit and implement IP P&Ps in HAI surveillance, outbreak identification, investigation, monitoring and reporting, and its failure to maintain a clean and sanitary environment. Additionally, the hospital's failure to establish a Water Management Program that was consistent with nationally recognized standards.

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DELIVERY OF SERVICES

Tag No.: A1134

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Based on observation, interviews, review of medical record documentation for 3 of 5 patients reviewed for aspects of rehabilitation services (Patients 5, 8, and 21), review of incident documentation for 2 of 2 patients reviewed for incidents involving rehabilitation services (Patients 2 and 5), and review of P&Ps it was determined that the hospital failed to ensure that safe and appropriate rehabilitation services were furnished to its medically complex and vulnerable patients. Failures included:
* Rehabilitation services assessments, notes, and IDT Conference documentation were not clear or complete.
* Rehabilitation services were not coordinated with nursing services and other disciplines involved with the patient and there was lack of rehab staff involvement in the IDT Conferences.
* The amount and frequency of rehabilitation services specified on the rehab plan of care were not followed.
* Rehabilitation staff failures resulted in patient incidents involving a Hoyer Lift for Patient 2 and a PMV or Speaking Valve for Patient 5.

Findings include:

1. For Patient 2 refer to the detailed findings under Tag A-145 regarding an incident where a PTA left the patient unattended and suspended from a Hoyer lift of 03/17/2022.

2.a. For Patient 5 rehabilitation services documentation of assessment, provision of care, and coordination with other disciplines was not clear or complete. For example:

2.b. For Patient 5 regarding the use of a PMV or Speaking Valve assessed and initiated by SLP. Review of the current online "Passy Muir" website reflected that a PMV or Passy-Muir Valve "is a simple medical device used by tracheostomy and ventilator patients. When placed on the hub of a tracheostomy tube or in-line with the ventilator circuit, the Passy Muir Valve redirects airflow through the vocal folds, mouth, and nose, enabling voice and improved communication ... improved swallow, and secretion management."
* On 12/19/2022 at 1516 an SLP signed a "ST Dysphagia Evaluation" that included "[Expressive Language]: WFL, able to have conversation with PMV on ... PMV trialed ... See PMV eval ... Speech Therapy Assessment ... PMV trials ... Speech Therapy Plan ... Pt will tolerate PMV all day with no supervision." This note was the first reference to a PMV. In regard to this note it was not clear if the PMV had been "trialed" or that "trials" were going to occur.
* On 12/19/2022 at 1601 an SLP signed a "ST Speaking Valve Evaluation" that included "Tracheostomy Tube Type: ... Cuffed ... Current Ventilator Support: Yes ... Tolerated Cuff Deflation: Yes ... Type of Speaking Valve: Passy-Muir ... Response to Speaking Valve: anxious ... Re-inflated Cuff: ... No - Comments: Communicated to RT about cuff down and PMV removal ... SLP Speaking Valve Recommendations: ... Speaking Valve placement with nursing supervision ... Speaking Valve worn for time period (indicated minutes/hours per day: [blank]." Under the "SLP Speaking Valve Recommendations" were also other pre-printed choices that were all not checked and included "Speaking Valve placement with ST and/or RT only" and "Speaking Valve placement without Supervision." The note reflected the SLP communicated to RT about the "cuff down and PMV removal" but it was not clear what that meant as in whether the RT was to remove the PMV for example. The note reflected that the PMV placement was not limited to ST or RT staff and that placement was "with nursing supervision." It was not clear what that meant as in who was to place the valve and what nursing supervision was to occur. Further, there was no reference to "communication" with the RN about the valve. There was no evidence of coordination with the RN responsible for the patient's care and the SLP related to PMV trials, placement, and management to ensure the provision of safe and appropriate care.
* On 12/19/2022 at 1932 a PT signed a note that reflected after the provision of services that "PMV doffed prior to exiting the room, per SLP recommendation." It was not clear whether the PT removed the PMV, or whether someone else had removed it, and there was no indication in the SLP evaluations, or of an RN assessment, related to who was permitted to place and remove the PMV.
* IDT Conference notes for "Date of Team Conference: 12/20/2022" reflected the SLP failed to address the patient's needs related to the use of a PMV in coordination with the nursing services and respiratory services. The "Speech Language Pathology" section of the conference form was completely blank
* IDT Conference notes for "Date of Team Conference: 12/28/2022" reflected the SLP failed to address the patient's needs related to the use of a PMV in coordination with the nursing services and respiratory services. The "Speech Language Pathology" section had been partially completed but there was no reference to the PMV.

2.c. On 01/01/2023 at ~ 1220 Patient 5 experienced an oxygen desaturation episode to 54% that resulted in respiratory distress for the patient and a "Rapid Response" team was called to the patient's room. Refer to the detailed findings under Tags A-145 and A-395 for Patient 5 regarding that incident that involved the improper placement of the PMV on the patient's trach.

2.d. On 01/05/2023 at 1400 a SLP signed a "ST Daily Session Note" that reflected "Pt seen for dysphagia [treatment] ... Pt seen to exhibit poor [vocal fold movement]. Pt with improved air way protection than before. Pt with weak coughs. Pt continues to exhibit reflux of thins and solid ... Pt seen to complete multiple swallows during the study on his own as pt wanted to do well on the study ... Trained pt on 2-3 swallows with each bite and wrote the strategy on the white board for better implementation ... Pt upgraded to PO snack, puree/thins. Continues with weak coughs." The "SLP Education" fields in the note were blank. There was no indication that anyone received dysphagia education or training about PO intake and aspiration precautions. It was not clear what was written on the "white board" as that information is eventually erased.

2.e. For Patient 5 refer also to Tag A-395 for additional details regarding lack of coordination of rehabilitation services with nursing and other services.

3.a. For Patient 8 rehabilitation services documentation of assessment, provision of care, and coordination with other disciplines was not clear or complete. For example:

3.b. For Patient 8 regarding the provision of OT services. On 12/04/2023 at 1603 an OT signed an "OT Initial Evaluation." The assessment was not clear or complete. For example:
* Related to the patient's upper extremities "ROM," the assessment reflected "Elbow ROM WFL Yes ... Forearm ROM WFL Yes ... Wrist ROM WFL Yes ... Hand ROM WFL Yes." There was no distinction between the patient's right extremity that had been fractured (Refer to Tag A-395) and the left extremity, and the "Strength" sections of the assessment were blank. A "ROM Comment" reflected "WNL AROM; grossly 4+/5 [manual muscle test] unable to fully assess wrists/forearm d/t mitts/restraints." The "Strength Comments" reflected "See above." It was unclear why ROM was identified as "WFL" when the comment stated that the OT was "unable to fully assess."
* The "Weekly plan - What is the plan for the next week or until the next team conference?" was blank.

3.c. For Patient 8 regarding the provision of PT services. On 12/05/2023 at 1048 a PT signed a "Physical Therapy Assessment." The assessment was not clear or complete. For example:
* The "ROM/Strength" section identified that ROM for hips, knees, and ankles was "[within functional limits] ... No." However, the fields that measured the amount of ROM and strength for each extremity were not completed and were blank. Further, a comment at the end of that section was written as "[lower extremity ROM within normal limits] which was contradictory to the ROM information for the hips, knees, and ankles above it.
* The "Activities of Daily Living Toileting Hygiene ... Toilet Transfer" were not completed. - The "PT Barriers to Discharge" section was blank.
* The assessment reflected "unable to don TLSO [brace] due to patient not cooperating with sitting up straight on edge of bed." It was unclear what "not cooperating" meant, whether that was verbal or non-verbal, purposeful and behavioral, or a result of physical inabilities.
* The "Physical Therapy Plan" was for "Skilled PT treatment 2-3 times/week for 6 weeks ... to address functional mobility including bed mobility, transfers, ambulation, stair negotiation, balance, strength, ROM/flexibility, endurance."
* The "Weekly plan - What is the plan for the next week or until the next team conference?" was blank.

3.d. "PT Daily Session Notes" for Patient 8 reflected the PT "Plan" for skilled treatment 2-3 times per week had not been followed and there was no evidence of a re-evaluation of the plan after the six weeks:
* There were no PT visits documented the week that began on 12/24/2023.
* There was only one PT visit documented the week that began on 01/07/2024, on 01/09/2024.
* There was only one PT visit documented the week that began on 02/04/2024, on 02/07/2024.
* There was only one PT visit documented the week that began on 02/11/2024, on 02/12/2024.
* There was only one PT visit documented the week that began on 02/18/2024, on 02/20/2024.
* There were no PT visits documented the week that began on 02/25/2024.

3.e. IDT Conference notes for Patient 8 reflected that neither PT or OT was involved in the patient's IDT conferences throughout the patient's hospital stay. For example: IDT Conference documentation reflected that the sections for "Physical Therapy" and "Occupational Therapy" had not been completed and were blank at the following IDT Conference dates: 12/06/2023, 12/13/2023, 12/27/2023, 01/10/2024, 01/24/2024, 02/07/2024, and 02/21/2024.

3.f. IDT Conference notes for Patient 8, additionally reflected for the following IDT Conferences dates that rehabilitation services documentation was unclear, incomplete, and lacked evidence of coordination with other disciplines: 12/06/2023, 12/20/2023, 01/03/2024, 01/17/2024, 01/31/2024, 02/28/2024, and 03/06/2024. For example: IDT Conference documentation for "Date of Team Conference: 12/06/2023" reflected under the section for "Speech Language Pathology ... Patient Status/Needs" reflected: "SLP 2 days per week 30 minutes per day ... Diet: NPO, ice chips - Discharge barriers: trach - SLP Goals/Plan of Care/Actions Continue per plan ... SLP Functional status goal(s): -tolerates cuff down and PMV, answered x1 w/ voice - not alert/responsive enough for PO, ice chips only -confused, variable alertness." It was not clear what "Continue per plan" referred to as neither dysphagia or communication was addressed on the patient's plan of care as indicated for Patient 8 under Tag A-396. The "Additional ST Comments:" section was blank. Although a "PT Initial Evaluation" had been conducted and signed on 12/05/2024 at 1048, PT was not included in the 12/06/2023 IDT Conference, or at any of the conferences held during the patient's hospital stay. Although an "OT Initial Evaluation" had been conducted and signed on 12/04/2023 at 1603, OT was not included in the 12/06/2023 IDT Conference.

3.g. For Patient 8 refer also to Tag A-395 for additional details regarding lack of coordination of rehabilitation services with nursing and other services.

29708

4. For Patient 21 refer to Tag A-395 for details regarding SLP services.

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RESPIRATORY CARE SERVICES POLICIES

Tag No.: A1160

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Based on observations, interviews, review of medical record documentation for 1 of 2 patients reviewed for aspects of respiratory therapy services (Patient 5), review of incident documentation for 1 of 1 patient reviewed for multiple incidents involving respiratory therapy services (Patient 5), and review of P&Ps it was determined that the hospital failed to ensure that safe and appropriate respiratory therapy services were furnished to its medically complex and vulnerable patients. Failures included:
* Respiratory therapy services assessments, notes, and IDT Conference documentation were not clear or complete.
* Respiratory therapy services were not coordinated with nursing services and other disciplines involved with the patient.
* Respiratory therapy staff failures to oversee and coordinate respiratory services with other disciplines resulted in three occurrences where the patient's oxygen saturation dropped to as low as 20%.
* Trach mask drainage bags were observed to be kept on the floor at patients' bedsides.

Findings include:

1.a. For Patient 5 respiratory therapy documentation of assessment, provision of care, and coordination with other disciplines was not clear or complete. For example:

1.b. For Patient 5 on 12/16/2022 at 1814 an RT signed an "RT Initial Pulmonary Evaluation." The evaluation was incomplete and unclear. For example: "Respirations ... Vent: Yes ... Visual Chest Assessment [No pre-printed choices checked] ... Does the patient have a Trach? Yes - Date Trach Placed: [blank] - Trach Type/Features: [blank - No pre-printed choices checked including N/A] - Trach Size: 6 - Trach Tube Secured: [blank, No pre-printed choices checked, including Other] - Trach Stoma Condition: [blank - No pre-printed choices checked including N/A] ... Vent Settings ... Spontaneous ... 1st Day on Vent 12/16/2022 - RT Assessment Comments: [blank] ... Number of Days Post-Trach Placement: [blank] - Additional Risks: [blank - No pre-printed choices checked including N/A] ... Planned Treatments - No Treatment [checked] ... Goals of Treatment: ... Clear Secretions [checked] ... Interventions: Assess Respiratory Status [checked] Auscultate Breath Sounds [checked] ... Respiratory Barriers to Discharge: [blank] - Respiratory Equipment Needs for D/C: [blank - No pre-printed choices checked including No Equipment] ... Did a complete drug regimen review identify potentially clinically significant oxygen issues? [Blank - No, Yes, and N/A all unchecked]." It was unclear whether the information that the patient's "1st Day on Vent" was 12/16/2022, the day of Patient 5's admission to Vibra, as the H&P completed by the physician indicated that the patient had been on a ventilator as early as 12/04/2022.

1.c. On 12/19/2022 an SLP documented the first references to the use of a PMV for Patient 5. Review of the current online "Passy Muir" website reflected that a PMV or Passy-Muir Valve "is a simple medical device used by tracheostomy and ventilator patients. When placed on the hub of a tracheostomy tube or in-line with the ventilator circuit, the Passy Muir Valve redirects airflow through the vocal folds, mouth, and nose, enabling voice and improved communication ... improved swallow, and secretion management."
* On 12/19/2022 at 1516 the SLP signed a "ST Dysphagia Evaluation" that included "[Expressive Language]: WFL, able to have conversation with PMV on ... PMV trialed ... Speech Therapy Plan ... Pt will tolerate PMV all day with no supervision."
* On 12/19/2022 at 1601 an SLP signed a "ST Speaking Valve Evaluation" that included "Tracheostomy Tube Type: ... Cuffed ... Current Ventilator Support: Yes ... Tolerated Cuff Deflation: Yes ... Type of Speaking Valve: Passy-Muir ... Response to Speaking Valve: anxious ... Re-inflated Cuff: ... No - Comments: Communicated to RT about cuff down and PMV removal ... SLP Speaking Valve Recommendations: ... Speaking Valve placement with nursing supervision ... Speaking Valve worn for time period (indicated minutes/hours per day: [blank]." Under the "SLP Speaking Valve Recommendations" were also other pre-printed choices that included "Speaking Valve placement with ST and.or RT only" and "Speaking Valve placement without Supervision." However, neither of those were checked. A note reflected only the SLP "Communicated to RT about cuff down and PMV removal" but it was not clear what that meant in relation to the RT's role and responsibilities for the PMV for example. There were no RT notes that provided clarification.

1.d. IDT Conference notes regarding the patient's respiratory needs were not clear or complete. For example in relation to the patient's trach and use of a PMV:
* IDT Conference notes for "Date of Team Conference: 12/20/2022" reflected that the "Respiratory Therapy" section of the form was incomplete and unclear. It reflected "Trach Collar/Capping/Decannulation/PMV [Yes for all of those]." However, under "Respiratory Goals/Plan of Care/Actions" the choices for "Trach Collar:" and "PMV:" and "Capping:" and "Decannulation" were blank and unchecked.
* IDT Conference notes for "Date of Team Conference: 12/28/2022" reflected the "Respiratory Therapy" section of the form was incomplete and unclear. It reflected "Trach Collar/Capping/Decannulation/PMV [Yes for all of those]." However, under "Respiratory Goals/Plan of Care/Actions" the choice for "PMV" was checked while the choices for "Trach Collar:" and "Capping:" and "Decannulation" continued to be blank and unchecked as for the prior conference. The only additional information related to the PMV was the notation written as "1:1." It was not clear what that meant.

1.e. On 01/01/2023 at 1014 an RT signed a "Clinical Assessment - AM" form that reflected "Trach ... Cuffed: Yes." There was no reference to the PMV and the "Speaking Valve" space on the form was unchecked and blank.

1.f. PSV refers to Pressure Support Ventilation, a positive pressure ventilation in which the patient triggers every breath. ATC refers to the Automatic Tube Compensation method of weaning from mechanical ventilation. Documentation related to the use of PSV and ATC modes for Patient 5 did not clearly reflect how or whether the use of PSV versus ATC impacted or contributed to the patient's decreased oxygen saturation levels:
* On 01/08/2023 at 1755 an RT signed a note that reflected "Received pt on PSV 10/ +5 30%. Triedx [sic] to put cap patient [sic] per normal routine at 0800. Pt became lethargic and SOB. Pt then placed on ATC at 30% @ 1100. Pt was not [sic] responded per normal and RN notified. Rapid response was called at 1720 per RT. SpO2 down to 20%. Ambu bag was used as well as sx [sic]. SpO2 increased. ABG drawn ... Pt then placed back on vent @ 1740. Per hospitalist, pt shall stay on vent for NOC [sic] shift and a repeat ABG in the am." The note was unclear regarding the "[Tried] to put cap [sic] patient" as it did not indicate the outcome of that attempt. The event timeline between 0800 and 1100 was unclear and did not specify when the patient began to be lethargic and SOB and if or when the patient's oxygen saturation returned to normal. Rapid Response was not called until 1720 and it was not clear what the patient's oxygen saturation level "increased" to.
* On 01/08/2023 at 1756, one minute after the RT signed the note above, the RT signed an "RT Ventilator Flowsheet ... Clinical Assessment AM" that reflected at "0800" the patient's oxygen saturation level was "95%" with the "Mode" as "PSV." The next entry on the flowsheet was at "1400" and was "95%" with the "Mode" as "OFF." The last entry on the flowsheet for that shift was at "1740" and was "96%" with the "Mode" as "PSV." Those entries did not clearly align with the RT's note signed at 1755.
* The "RT Ventilator Flowsheet ... Clinical Assessment PM" was not completed at all for the night shift that began on 01/08/2023 and ended in the morning of 01/09/2023.

1.g. For Patient 5 refer to the detailed findings under Tags A-145 and A-395 regarding incidents of significant drops of the patient's oxygen saturation level. There was lack of clear and thorough respiratory assessment and investigation to determine why those events occurred, and to develop and implement corrective actions to prevent recurrence.
* On 01/01/2023 the patient experienced an oxygen desaturation episode to 54% that resulted in respiratory distress for the patient and a "Rapid Response" team was called to the patient's room. That incident involved the improper placement of the PMV on the patient's trach.
* On 01/08/2023 another incident of a significant drop in the patient's oxygen saturation down to 20% occurred and the "Rapid Response" team was called. That incident occurred when the ATC mode was in use.
* On 01/14/2023 a third incident of a significant drop in the patient's oxygen saturation down to 51% occurred and the "Rapid Response" team was called. That incident occurred when the patient's HOB was lowered.

1.h. For Patient 5 refer also to Tag A-395 for additional details regarding lack of coordination of respiratory therapy services with nursing and other services.

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2. For Patient 22 refer to Tag A-750 regarding trach mask drainage bags on the floor.

3. For Patient 23 refer to Tag A-750 regarding trach mask drainage bags on the floor.

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DISCHARGE PLANNING TIMELY EVALUATION

Tag No.: A0805

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Based on interview and documentation in 3 of 3 medical records reviewed for aspects of discharge planning (Patients 4, 8, and 13) it was determined that the hospital failed to ensure the provision of safe and appropriate discharge planning services to its medically complex and vulnerable patients. Failures included:
* Necessary medical equipment, including a suction machine, was not delivered to the home of a patient discharged on a ventilator to ensure the provision of safe and appropriate care in the residence.
* Discharge planning documentation was not timely, and in relation to plans for discharge to home a patient's representative was informed that use of restraints in a private residence was "illegal." It was unclear whether that was accurate information, it had the potential to be interpreted as a threat by staff, and had the further potential to dissuade the representatives from taking the patient home.
* On the date of discharge a patient's arm was injured by hospital staff. The patient's representative was informed that the planned discharge would need to occur and the representatives would need to transport the patient to an acute hospital ED for evaluation of the injury, instead of having the injury evaluated at Vibra. That was not consistent with safe and appropriate discharge planning services and ultimately other hospital staff intervened and the patient was not discharged at that time. The injury was subsequently diagnosed as a fracture.

Findings include:

1.a. The medical record "Facesheet" for Patient 4 reflected that they were transferred from an acute care hospital and admitted to Vibra on 12/20/2022 at 1740. They were discharged to a private residence on 12/31/2022 at 0800.

1.b. IDT Conference notes reflected "Date of Team Conference: 12/28/2022," three days prior to discharge to home. The Case Manager was listed as in attendance at the meeting. However, the "Case Management Discharge Plan/Barrier" section of the conference form had not been completed. The "Discharge Plan" space was blank and the "Patient Discharge Status __ Ready for discharge __ NOT ready for discharge" spaces were blank. All remaining fields in the Discharge Plan section of the form were blank. Those included: "Discharge Barriers ... Patient/Family/Caregiver discharge needs/expectations ... Projected discharge date ... Case Management Goals/Plan of Care/Actions ... Arrange Equipment ..." The form was electronically signed by the Case Manager on 12/30/2022 at 1354.

1.c. The IDT "Discharge Instructions" form was signed by the Case Manager on 12/29/2022 at 1020, two days prior to discharge. Under the section for "Respiratory Therapy" it reflected that the patient was being discharged home on a ventilator with oxygen and a nebulizer and had the following DME needs for home: "Trach supplies, Ventilator and supplies, O2 concentrator and supplies, Suction machine and supplies, Cough assist and supplies, Neb compressor and hand held nebulizer."

1.d. A note in the medical record electronically signed by the Case Manager on 01/04/2023 at 1353, after Patient 4's discharge on 12/31/2022, reflected they had "... created DME order ... on 12/29/22 at 1220 ... Received message ... on 12/30/22 at 1016 and 1044 stating that Lincare would not be able to supply trach supplies ... but would be able to provide suction and hoyer w/sling. RNCM reached out to Apria and faxed orders to Apria. Apria replied stating that they would not be able to transition patient to invasive vent or provide supplies (patient has been discharged) ...."

1.e. There was no documentation by the Case Manager prior to the patient's discharge to reflect that medical equipment discharge needs had been evaluated timely and that plans had been made and confirmed to ensure equipment was delivered to the place of residence prior to the patient's discharge.

1.f. During interview with the CMD on 11/14/2024 at 1545 they stated that Patient 4's discharge needs for medical equipment had not been met. They confirmed that the Case Manager assigned to Patient 4 had failed to take steps to ensure all necessary equipment was in place at home at the time the patient was discharged. They stated the hospital made changes to discharge practice as a result of this incident and required that patients would not be discharged until all necessary equipment was confirmed to have been delivered to their place of residence. A request was made for documentation to confirm that the described change had been implemented and was monitored, however, no additional information was provided.

2.a. Patient 8 was discharged on 03/06/2024. Documentation related to discharge planning was not clear or timely. Further, it was unclear whether the patient's representatives were provided with accurate information about the use of restraints for the patient in a private residence. For example:
* On the date of discharge, 03/06/2024 at 1520, an RRT signed a note under a date/time stamp of 12/07/2023 at 1020, three months earlier, that reflected "Received call from [family] informing that [they want the patient] to be discharged to come home ... as soon as possible ... Expelling [sic] that RT has started to cap trach and could be decanulated [sic] within a week or so, about [Patient 8's] wound/fractures, that right hand now has a wire exposed, has TLSO with spinal precautions, and has appointment scheduled with Orthopedic Surgeon on Dec. 15th ... Informed also that pt has restraints on for intermittent agitation, also has PEG tube ... trach care, wound care, and tube feedings ..."
* On the date of discharge, 03/06/2024 at 1554, the RRT signed another note under a date/time stamp of 12/07/2023 at 1557, three months earlier, that reflected "Called [family] to discuss DC plans ... did discuss potential comfort care and hospice, informed possible permanent trach and noc [ventilator] ... on restraints for agitation ... and that it is illegal to have [the patient] on restraints at home ... full care ..."
* On 03/06/2024 at 1633 the RRT signed a note that reflected a family member stated "... that [they weren't] going to take [the patient] home unless [they] got a letter stating that pt is being released to a lower level of care .... demanding this letter, and if [they don't] get it [they weren't] going to pick [the patient] up, [they] started saying the [sic] this RN CM told [family member] before that [patient] can't be [discharged because they are] in a Posey, that it's illegal ... let [family member] know that [they] must have misunderstood ..." However, the RRT themselves recorded the note on 03/06/2024 at 1554 in which they wrote "Called [family] ... informed ... that it is illegal to have [the patient] on restraints at home ..."

2.b. The problems and needs identified in the RRT's notes related to the trach and decannulation, a "wire exposed" on the patient's right hand, the "TLSO with spinal precautions," restraints for "intermittent agitation," the PEG tube and tube feedings, wound care, comfort care and hospice, "permanent trach" and ventilator at night, and "full care" had not been clearly or completely assessed by nursing and the other disciplines on 12/07/2022, nor included in the patient's plan of care. (Refer to the findings for Patient 8 under Tag A-395 and other Tags in this report.) Therefore it was not clear whether the RRT's discussions with the representative about the patient's problems and needs on 12/07/2023, three months prior to the documentation of the note, were accurate. Further, it was unclear whether the RRT's statement that the use of restraints in a private residence by family members is "illegal," was accurate. It was unclear what basis the RRT had for making this statement. The statement further complicated the discharge planning for a complex case and could have been interpreted as a threat to keep the patient from being discharged to home as requested by the family. In addition, the RRT documented that the family "must have misunderstood" when the RRT themselves documented that they informed the family the use of "restraints at home" was "illegal."

2.c. In an email received from the CMD on 01/23/2025 at 1451 they confirmed that the staff person who wrote and signed the discharge planning notes on 03/06/2024 as an "RRT" was not an RRT but was licensed as an RN.

3. For Patient 13 refer to Tags A-144 and A-395 regarding the detailed findings related to the fracture of the patient's arm that occurred on the day of discharge.

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