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Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.11 Compliance with Federal, State and Local Laws, was out of compliance.

A-0021- The hospital must be in compliance with applicable Federal laws related to the health and safety of patients. Based on video review, document review and interviews, the facility failed to have a nurse staffing committee that met the requirements of the Standards for Hospitals and Health Facilities Chapter 4.14.6 and a master nurse staffing plan that met the requirements of Chapter 4.14.7. In addition, the facility failed to report an occurrence of potential physical abuse to the State Agency.

Based on video review, document review and interviews, the facility failed to have a nurse staffing committee that met the requirements of the Standards for Hospitals and Health Facilities Chapter 4.14.6 and a master nurse staffing plan that met the requirements of Chapter 4.14.7. In addition, the facility failed to report an occurrence of potential physical abuse to the State Agency.

Findings include:

Facility policies:

The Critical Incident Reporting policy read, critical incidents that meet the criteria for reporting to Colorado Department of Public Health and Environment (CDPHE) will be reported by the next business day after discovering the incident. See Health Facilities and Emergency Medical Services Division (HFEMSD) occurrence reporting manual for details.

The Seclusion and Restraint policy read, the purpose is to protect the health, safety, rights, dignity and well-being of all patients and to designate the criteria by which it can be determined that the use of seclusion or restraint is warranted. All patients will receive considerate and respectful care, free of unnecessary seclusion or restraints. Seclusion is defined as the involuntary confinement of a patient alone in a room or area from which the patient is physically prevented from leaving.

Reference:

The HFEMSD Occurrence Reporting Manual read, an occurrence was any allegation involving physical abuse of a patient by an employee of the facility. Two elements are needed: intent or knowingly or recklessly, and bodily injury and/or unreasonable confinement or restraint.

1. The facility failed to develop and implement a nurse staffing committee consisting of at least 60 percent participation of clinical staff nurses and that met the requirements of Chapter 4.14.6.

a. On 9/28/22 at 9:35 a.m., an interview with licensed practical nurse (LPN) #26 was conducted. LPN #26 stated she was not aware of a nurse staffing committee at the facility.

b. On 9/28/22 at 8:46 a.m., an interview with registered nurse (RN) #37 was conducted. RN #37 stated she was not involved in or aware of a nurse staffing committee at the facility.

c. On 9/28/22 at 3:23 p.m., an interview with the director of nursing (DON) #8 was conducted. DON #8 stated she was not aware of the requirement of having a nurse staffing committee.

The facility was unable to provide evidence of meeting the requirement of having a nurse staffing committee prior to the exit of the survey.

2. The facility failed to develop and implement a master nurse staffing plan that met the requirements of Chapter 4.14.7.

a. On 9/28/22 at 8:46 a.m., an interview with registered nurse (RN) #37 was conducted. RN #37 stated she was not involved in or aware of a master nurse staffing plan at the facility.

b. On 9/29/22 at 10:11 a.m., an interview with the director of nursing (DON) #8 was conducted. DON #8 stated she was unaware of the requirement of having a master nurse staffing plan that included strategies to promote the health, safety and welfare of the facility's employees and patients. DON #8 further stated the facility did not have a master staffing plan that included a process for reducing nurse-to-patient assignments to align with the demand based on patient acuity. DON #8 then stated she was unaware of the requirement of having a master nurse staffing plan that was updated quarterly, voted on by 60 percent of a nurse staffing committee, and reported to the facility's governing body for approval.


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3. The facility failed to ensure an occurrence of unreasonable confinement was reported to the State Regulatory Agency according to facility policy.

a. On 9/25/22 at 4:00 p.m., video footage of the seclusion area of unit 300 was reviewed. Video footage revealed Patient #3 was left alone numerous times in the seclusion area with the door shut and locked between 7:00 p.m. and 8:26 p.m.

b. Patient #3's medical record was reviewed. Patient #3 presented to the facility for treatment and was admitted 9/19/22. The patient's abuse and trauma history note completed on 9/20/22 read the patient has issues with locked rooms and being restrained against his will. The risk for trauma was high.

Further review of Patient #3's medical record revealed there was no evidence an order for seclusion was placed by a provider nor was there evidence of seclusion or restraint documentation.

Video review and record review was in contrast to the HFEMSD Occurrence Reporting Manual which read physical abuse, such as knowingly or recklessly confinement of a patient, was to be reported.

c. On 10/5/22 at 10:45 a.m., an interview was conducted with Quality Assurance Improvement Registered Nurse (Quality RN) #17 and Quality Improvement Manager (Manager) #18. Manager #18 stated a reportable occurrence was as defined in the HFEMSD occurrence manual. Manager #18 stated she was responsible for reporting occurrences to the State Agency. Manager #18 stated it was important to submit occurrences to the State Agency because it was the law and the facility wanted to do what was best to mitigate risks to patients. Manager #18 stated she did not think the seclusion of Patient #3 needed to be reported to the State Agency as an occurrence because staff members were outside the door and it was not considered as an unreasonable restraint or confinement.

However, the interview was in contrast to the facility policy which read seclusion was when a patient was left alone in a room or area and was not allowed to leave.

d. On 9/25/22 at 4:55 p.m. an interview was conducted with Chief Medical Officer (CMO) #9. The video footage reviewed of Patient #3's incident was discussed. CMO #9 stated the quality team reviewed the video and determined the episode was an episode of seclusion.

Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.13 Patient's Rights, was out of compliance.

A-0117 A hospital must inform each patient, or when appropriate, the patient's representative (as allowed under State law), of the patient's rights, in advance of furnishing or discontinuing patient care whenever possible. Based on interviews and record review, the facility failed to ensure a patient placed on an M-1 hold (involuntary 72 hour hold for evaluation and treatment of mental illness) was notified of their rights in one of one medical record reviewed of patients placed on an M-1 hold in the admissions area then transferred to a separate facility. (Patient #29)

A-0131 The patient or his or her representative (as allowed under State law) has the right to make informed decisions regarding his or her care. The patient's rights include being informed of his or her health status, being involved in care planning and treatment, and being able to request or refuse treatment. This right must not be construed as a mechanism to demand the provision of treatment or services deemed medically unnecessary or inappropriate. Based on document review and interviews, the facility failed to ensure patients' representatives were notified of their care in one of one medical record reviewed of a minor who arrived to the facility on an M-1 hold (involuntary 72 hour hold for evaluation and treatment of mental illness). (Patient #23)

A-0144 The patient has the right to receive care in a safe setting. Based on video review, interviews and record review, the facility failed to ensure patients were monitored and observed in the admissions area in three of three video reviews conducted (Patients #29, #30, and #31). Additionally, the facility failed to ensure staff were trained to perform tasks as assigned. Specifically, the facility did not ensure outpatient peer support professionals (PSP) were trained to monitor patients in the crisis assessment area of the hospital.

Based on interviews and record review, the facility failed to ensure a patient placed on an M-1 hold (involuntary 72 hour hold for evaluation and treatment of mental illness) was notified of their rights in one of one medical record reviewed of a patient placed on an M-1 hold in the admissions area then transferred to a separate facility. (Patient #29)

Findings include:

Facility policy:

The Initiating a 72-hour Hold policy read, the purpose of the policy was to provide guidance to staff when initiating a 72 hour hold (M-1), to ensure M-1 criteria have been met, and to ensure client's rights are being protected. The policy defines M-2 as a form that briefly outlines both a client's rights and responsibilities while receiving services from the facility. This form is intended to better understand the needs of cooperation between client, doctor, therapist, or other care providers. This form must be reviewed with and signed by the client at each change in the identified level of care for that client. In the event that a client is unwilling or unable to sign, facility staff must indicate the reason at the bottom of the form.

1. The facility failed to ensure a patient placed on an M-1 hold was provided their rights.

a. Medical record review revealed Patient #29 had a history of chronic schizophrenia (mental disorder in which reality is interpreted abnormally). On 10/4/22, Patient #29 was brought to the facility and placed on an M-1 hold for being gravely disabled. The facility was unable to provide evidence that the M-2 (a form listing patient rights reviewed with the patient when placed on a M-1 hold) had been provided to, or signed by Patient #29. The facility was also unable to provide evidence that Patient #29 had been unwilling or unable to sign the M-2 documentation.

This was in contrast to the Initiating a 72 Hour Hold (M-1) policy, which read staff were to ensure a client's rights had been protected and the M-2 form was intended to better understand the needs of cooperation between client, doctor, therapist, or other care providers. Staff were to review with and sign by the client at each change in the identified level of care for that client. In the event a client was unwilling or unable to sign, facility staff would indicate the reason at the bottom of the form.

b. On 10/10/22 at 12:35 p.m., an interview was conducted with crisis clinician (Clinician) #29. Clinician #29 stated she assumed the staff who completed the M-1 would also complete the M-2 documentation with the patient. Crisis Clinician #29 also stated the documentation that a patient was unable to sign was expected to be documented on the M-2 form and was not documented elsewhere in the electronic medical record (EMR).

c. On 10/11/22 at 10:32 a.m., an interview was conducted with clinical operations manager (Manager) #30. Manager #30 stated once a patient had been placed on a M-1 hold, it was expected that staff reviewed the rights with the patient and had the patient sign documentation noting that they had received the rights. Manager #30 also stated if the patient was unable to sign the documentation, staff were expected to document their inability to sign on the M-2 form. Furthermore, Manager #30 stated it was important that staff informed patients of the rights they were entitled to while hospitalized.

Based on document review and interviews, the facility failed to ensure patients' representatives were notified of their care in one of one medical record reviewed of a minor who arrived to the facility on an M-1 hold (involuntary 72 hour hold for evaluation and treatment of mental illness). (Patient #23)

Findings include:

Facility policy:

According to the policy Seclusion and Restraints, in the case of seclusion or restraint of minor, age eighteen (18) or younger, the patient's family, or legal guardian must be notified of the episode.

1. The facility failed to ensure Patient #23's guardian was notified of the patient's rights and of an episode of seclusion.

a. Medical record revealed Patient #23 was a seventeen year old patient who arrived at the facility on 9/14/22. Review of a document titled Behavioral Management Consent revealed an explanation of the possibility of a patient requiring the use of a quiet room or physical restraint. The Legal Guardian section of the form included an area for the patient's guardian to initial for giving or refusing consent to utilizing the quiet room or physical restraint if necessary. There were no initials documented in this area. In addition, under the Signature of Legal Guardian section of the form, documentation stated the patient was "too symptomatic" to sign the form. There was no documentation of a guardian's signature or that the guardian was notified of the form.

Review of a document titled Client Release of Information listed the patient's mother to receive, exchange, use or disclose information about the patient. The form further revealed the patient indicated verbally that she would like her mother to be able to visit.

Further review of the medical record revealed an order created on 9/14/22 at 10:07 p.m. for the patient to be placed in seclusion due to the patient being disorganized, combative with peers and staff, attending to internal stimuli and a danger to self and others. According to the Client Observation Report, Patient #23 was located in seclusion on 9/14/22 from 10:00 p.m. through 11:00 p.m.

There was no documentation indicating the patient's guardian was notified of the episode of seclusion. This was in contrast with the policy Seclusion and Restraints which read, in the case of seclusion or restraint of a minor, age eighteen or younger, the patient's family, or legal guardian must be notified of the episode.

b. On 10/12/2022 at 12:30 p.m., an interview with registered nurse (RN) #38 was conducted. RN #38 stated minors were considered patients under the age of eighteen. RN #38 explained staff were expected to notify a minor patient's guardian if the patient was placed in seclusion or if physical restraints were used. RN #38 further stated it was important to inform guardians in patients' treatment in order to involve them in the patients' treatment.

c. On 10/12/22 at 1:21 p.m., an interview with the Quality Assurance Improvement RN (Quality RN) #17 was conducted. Upon review of Patient #23's medical record, Quality RN #17 confirmed there was no evidence of the patient's guardian being notified of the episode of seclusion on 9/14/22. Quality RN #17 stated the expectation was for staff to notify minor patients' guardians about episodes of seclusion so that the guardian could be involved in the treatment planning and make informed decisions on behalf of the patient.

Based on video review, interviews and record review, the facility failed to ensure patients were monitored and observed in the admissions area in three of three video reviews conducted (Patients #29, #30, and #31). Additionally, the facility failed to ensure staff were trained to perform tasks as assigned. Specifically, the facility did not ensure outpatient peer support professionals (PSP) were trained to monitor patients in the crisis assessment area of the hospital.

Findings include:

Facility policy:

The Standard Observations in Admission Area policy read, all patients are monitored appropriately so that a safe and secure environment is maintained. This policy applies to the facility's staff and any staff from a separately licensed facility working in the admissions area.

Responsibilities include: Crisis clinicians: are responsible for creating observation assignments as needed. Crisis case managers: are responsible for creating observation assignments as needed and for completing standard observations per this policy. Intake coordinators: are responsible for creating observation assignments as needed and for completing standard observations per this policy.

Definitions: standard observation: conducted every 15 minutes, visual face to face contact with clients, shall not be completed via camera or other electronic monitoring devices. Observation requires verbal confirmation from Client when in restroom. Observation requires staff to confirm patient's wellbeing while asleep (look for breathing and chest movement). Monitoring the patient to see that the patient's chest is rising and falling with each respiration, listen for breath sounds. Use a flashlight to observe each patient, if necessary for visualization. If the patient has their head covered with linens, staff will gently ask the patient to uncover their head and neck so staff can clearly visualize the patient's head and breathing. Other visualization methods such as turning on lights, uncovering patient, etc. will be used, if required.

Standard observations will occur a minimum of every (15) minutes 24-hours per day. Observations will be direct, not via video, and will begin upon arrival and be continuous until placed in higher level of care or safety planned. The crisis case managers and/or intake coordinators are responsible for completing standard observations throughout their shifts.

Facility documents:

The Peer Support Professional (PSP) outpatient services job description read, must be someone with lived experience with mental health or substance conditions. Prior peer support training is preferred or employee must complete 80 hour Peer Support Training once hired. As part of a multidisciplinary team, the PSP will provide direct support to individuals experiencing mental health and co-occurring challenges. They will serve as a client advocate within systems, provide mentoring and education and model wellness and recovery. PSPs work directly with adults, adolescents, children and their families/supports. The PSP will follow ethical guidelines set in place by the National Association of Peer Supporters (NAPS) in order to perform a wide variety of tasks, supporting clients in regaining control over their own recovery. PSPs provide voluntary, strength focused, person driven support in group and individual settings. Knowledge, Skill & Ability: ability to organize and prioritize workload in a sometimes hectic environment with frequent interruptions. Organizational skills and creative problem solving skills. Knowledge and ability to apply de-escalation skills. Ability to observe, report and document a client's recovery process in the electronic health record. Ability to utilize individual and group supervision to develop proficiency in peer role.

The Mental Health Worker (MHW) job description read, Provides direct services and supervision to the clients in the Child and Adolescent Program and/or the Adult Inpatient Program. Coordinates care with other clinical and medical staff as necessary, and as directed per Multidisciplinary Treatment Plans. Interacts with clients and provides support, structure, stability, and positive role modeling. Knowledge, Skill & Ability: Ability to relate in a supportive and non-judgmental manner with persons in distress. Ability to observe and describe behavior and/or symptomatic changes. Knowledge of mental illness and psychopathology and associated treatment modalities. Working knowledge of Colorado Revised Statutes 27-65 (Mental Health Code). Knowledge of community health and mental health resources and their eligibility criteria. CPR/First Aid Certification required (training for certification is available).

Crisis Prevention Institute (CPI) Training/Certification required. Must have ability to perform duties required by CPI training to provide verbal de-escalation and physical and mechanical restraints if necessary (Training for certification will be provided).

1. The facility failed to ensure standard observations were conducted in the admissions area.

a. Video review revealed patients in the admissions area did not receive face to face observation checks by staff every 15 minutes in accordance with facility policy.

i. Review of video footage for Patient #29 was conducted with quality assurance improvement registered nurse (Quality RN) #17. Video review revealed Patient #29 arrived at the facility on 10/4/22 at 5:11 a.m. and was placed in a crisis room for assessment. At 5:27 a.m., crisis clinician (Clinician) #33 was seen at the patient's doorway for a total of 17 seconds. At 5:35 a.m., Clinician #33 returned and stood in the doorway to observe the patient for 17 seconds. At 8:16 a.m., two hours and 46 minutes later, the patient departed from the facility. There was no evidence of the patient receiving a face to face observation every 15 minutes between 5:35 a.m. and 8:16 a.m.

ii. Review of video footage for Patient #30 revealed the patient arrived on 9/28/22 at 12:17 p.m. and left the facility at 1:54 p.m. During this time period, the patient was seen by a facility staff member at 1:16 p.m. in an admissions crisis room. There was no indication the patient was observed every 15 minutes throughout their visit.

iii. Review of video footage for Patient #31 revealed Patient #31 was brought into a crisis admission room at 10/4/22 at 5:42 p.m. and departed from the facility at 7:26 p.m. During this period of time, there was no evidence the facility monitored and observed the patient every 15 minutes.

Video review of the patients was in contrast to facility policy which read, standard observations were to be conducted every 15 minutes and were to be done face to face with the patient.

b. Interviews revealed conflicting statements on the process for observing patients in the admissions area.

i. On 9/27/22 at 4:00 p.m., crisis clinician (Clinician) #31 was interviewed. Clinician #31 stated when a patient was in the admissions crisis rooms, a staff member was to be present and sit with the patient at all times. Clinician #31 stated she did not understand why a staff member had to sit with the patient since there were cameras to monitor the patient at the admissions intake desk.

ii. On 10/4/22 at 10:45 a.m., case manager (Manager) #36 was interviewed. Manager #36 stated the staff were told to be in the admissions area and observe the patient every 15 minutes. Manager #36 stated she did not document her every 15 minute observations of patients.

iii. On 10/10/22 at 12:35 p.m., an interview was conducted with crisis clinician (Clinician) #29. Clinician #29 stated the facility had a new process and all patients were not to be left alone. Clinician #29 further stated if the patient was to be admitted to the facility, the admissions staff were responsible for conducting observations every 15 minutes. Clinician #29 was unaware of how documentation was to be done for 15 minute checks.

iv. On 10/11/22 at 10:32 a.m. an interview was conducted with clinical operations manager (Manager) #30. Manager #30 stated the current expectation for observations in the admissions areas was for the patient to have one to one observation. Manager #30 stated the one to one observation was not documented in the medical record. Manager #30 stated since the observations were not documented in the medical record, it was difficult to determine whether or not patients were being observed per policy.


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2. The facility failed to ensure outpatient peer support professionals (PSP) were trained and qualified to monitor patients in the crisis admission area of the hospital.

a. On 9/27/22 at 12:21 p.m., observations were conducted in the admission area of the hospital. Peer support professional (PSP) #1 was sitting in the admission area waiting for a patient's skin check to be completed so she could monitor the patient. An interview during the observation revealed she was an outpatient PSP who was called from the outpatient facility to sit with a crisis patient in the admission area of the hospital. PSP #1 stated she had not received any orientation or training to work in the hospital admission area.

b. On 9/27/22 at 10:26 a.m., an interview was conducted with PSP #2 and PSP #3. Both PSP #2 and PSP #3 stated they had never been oriented to the crisis admission area of the hospital since they were employed by the outpatient facility. They stated when they worked in the admission area, they were not sure what their responsibilities were, other than to sit with the patient and keep the patient in their line of sight. Both stated they had never reviewed a policy with crisis admission area expectations and did not document any patient monitoring while they were there. Both stated they had never received CPI training from the facility to de-escalate a crisis patient.

PSP #3 stated she was new to the PSP role and did not receive reports on patients she was to sit with. PSP #3 stated she was often scared when sitting with patients in the crisis area since she had no way to call for assistance if a patient got violent other than to email her outpatient coworkers. She stated she did not know how to call a hospital code to get assistance if needed since she had only been trained to work in the outpatient setting.

PSP #2 stated she has had to sit with a patient with active psychosis before and was scared since she did not know what to do when the patient had escalating behavior and was throwing things. She stated the outpatient PSPs relied on each other for guidance. PSP #2 stated she and her PSP peers had asked for training on more than one occasion but had not received any training. She stated she was not sure who to ask for inpatient training other than her supervisor.

c. Review of the Standard Observations in Admission Area policy (see above) revealed expectations for crisis clinicians, crisis case managers and intake coordinators. There were no PSP expectations in the policy.

d. On 9/28/22 at 1:41 p.m., outpatient peer support coordinator (Peer Coordinator) #21 was interviewed. Peer Coordinator #21 stated she supervised the outpatient peer support professionals and coordinated their training. She stated she was not involved in the training the PSPs received when they started sitting with patients in the crisis admission area of the hospital. She stated due to immediate staffing needs, the process was to have outpatient PSP sit with patients in the crisis admission area. She stated she felt they did not receive adequate training. Peer Coordinator #21 stated the outpatient PSPs should have received training on their expectations as admissions support, should have been provided a policy and should have completed CPI and CPR training. Peer Coordinator #21 stated PSP #1, PSP #2 and PSP #3 were the newest PSPs in the outpatient area and were selected to assist in the hospital crisis area, not because they were determined to have the training, but because they had the lightest outpatient schedule.

e. Review of PSP #1, PSP #2 and PSP #3's personnel files revealed they had not been trained or deemed competent to work in the inpatient crisis admission area. None of the three outpatient PSPs had CPI training provided to them by the facility, or training on how to monitor for patient safety and de-escalate a situation if needed or to call a code for staff assistance.

f. On 9/29/22 at 11:50 a.m., an interview was conducted with chief executive officer (CEO) #25. CEO #25 stated the PSPs were expected to sit with crisis admission patients and provide one to one supervision. He stated the outpatient PSPs did not have the same amount of de-escalation training that the inpatient PSPs had. CEO #25 stated the training should be the same if they were working in the hospital admission area.

Based on the manner and degree of the standard level deficiencies referenced to the Condition, it was determined the Condition of Participation §482.21 QAPI CONDITION, was out of compliance.

A-0286 (a),(c)(2),(e)(3) PATIENT SAFETY (a) Standard: Program Scope (1) The program must include, but not be limited to, an ongoing program that shows measurable improvement in indicators for which there is evidence that it will ... identify and reduce medical errors. (2) The hospital must measure, analyze, and track ...adverse patient events ... (c) Program Activities ..... (2) Performance improvement activities must track medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning throughout the hospital. (e) Executive Responsibilities. The hospital's governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative officials are responsible and accountable for ensuring the following: ... (3) That clear expectations for safety are established. Based on interviews and document review, the facility failed to ensure incidents involving patient care were analyzed and had interventions put into place to ensure they did not reoccur. (Cross reference A-0405 and A-0492)

A-0308 Standard Tag for requirements found only in Condition stem statement §482.21 Condition of Participation: Quality Assessment and Performance Improvement Program ... The hospital's governing body must ensure that the program reflects the complexity of the hospital's organization and services; involves all hospital departments and services (including those services furnished under contract or arrangement) ... The hospital must maintain and demonstrate evidence of its QAPI program for review by CMS. Based on document review and interviews, the facility failed to ensure all departments were involved in the Quality Assessment and Performance Improvement (QAPI) Program.

Based on interviews and document review, the facility failed to ensure incidents involving patient care were analyzed and had interventions put in place to ensure they did not reoccur. (Cross reference A-0405 and A-0492)

Findings include:

Facility policy:

The Critical Incident Reporting policy defined a Critical Incident and/or Patient Safety Event as an event, incident, near miss, or condition that could have resulted or did result in harm.

Reference:

The Quality and Safety Improvement Program read, The Quality Improvement Manager collaborates with senior hospital leadership to manage the completion of all investigations of quality of care concerns, critical incidents, and adverse events. The Quality Improvement Committee (QIC) is responsible for reporting significant findings and recommending actions to the Quality Assurance & Performance Improvement (QAPI) board, governing body, MEC and hospital administration. The Critical Incident Review (CIR) Committee is responsible for reviewing the trends on all critical incident reports and completing case reviews. The CIR Committee will review overall trends from sub-committees and complete case reviews on all major incidents. Significant quality of care concerns and sentinel events will be brought forward to the Standard of Care (SOC) Committee. The SOC Committee will review audit findings on medical and clinical staff and high-risk situations/incidents referred from any concerned staff member or by the Critical Incident Review Committee.

The QIC, SOC, and their subcommittees will do the following: Collaborate with department managers, staff, and others to create and implement corrective actions to address identified areas for improvement. Disseminates lessons learned from comprehensive systematic analyses (i.e. RCAs, CIR data, proactive risk assessments) to all staff who provide services for the applicable situation.

1. The facility failed to ensure interventions were implemented to reduce the risk of recurrence from an event resulting in a critical incident report (CIR) and root cause analysis (RCA).

a. A CIR dated 8/16/22 regarding Patient #16 was reviewed. Patient #16 was at the facility from 8/13/22 through 8/15/22 for treatment of paranoia. According to the CIR, Patient #16 died after driving her vehicle off of the road on 8/16/22, one day after being discharged from the facility. The CIR reported a RCA was determined to be conducted.

b. On 10/11/22 at 2:00 p.m., an interview with the quality assurance improvement RN (Quality RN) #17 was conducted. Quality RN #17 stated she was involved with incidents occurring with patients receiving inpatient care. Quality RN #17 stated it was determined that the outpatient quality team was responsible for the RCA investigation involving Patient #16 because the incident occurred after the patient was discharged from the facility. Quality RN #17 further stated that although both the inpatient and outpatient departments reviewed the incident, she was not involved in the RCA investigation of the incident involving Patient #16.

c. On 10/11/22 at 3:14 p.m., an interview with the outpatient compliance manager (Manager) #34 and the outpatient quality improvement manager (Manager) #35 was conducted. Manager #34 verified the outpatient quality team was responsible for conducting the RCA of the incident that occurred on 8/16/22 with Patient #16. Manager #35 stated the incident had been reported by the police department as an accident. Upon reviewing the RCA, Manager #34 stated one of the action items determined from the investigation was for staff to receive training on the process of conducting safety plans with patients. Manager #34 stated she was unaware of any training being conducted with staff about conducting safety plans.

Upon further request for evidence of staff training regarding the process of safety planning with patients, an email was received from Manager #35 on 10/12/22 at 10:01 a.m. Manager #35 reported the action item regarding staff training on safety planning procedures had not yet been addressed.

2. The facility failed to ensure a CIR regarding the occurrence of change of condition was analyzed and that interventions were implemented in order to decrease the risk of recurrence.

a. A CIR dated 8/5/22 regarding Patient #22 was reviewed. Patient #22 was admitted to the facility on 8/4/22 for treatment of a suicide attempt by overdose. According to the CIR, Patient #22 was seen by family nurse practitioner (FNP) #12 on 8/5/22, who was concerned about the patient's condition. The CIR further read FNP #12 was worried about the possibility of Patient #22 sneaking in drugs and using them or that the patient was experiencing serotonin syndrome (serious syndrome that could occur after taking medications affecting serotonin levels). According to the CIR, Patient #22 was transferred to a medical facility in order to have labs drawn.

A Supervisor Review conducted by a physician reported no abnormal drugs were detected and no further education or training were recommended regarding the incident.

This was in contrast to Patient #22's medical record which documented the patient's lab results from the medical facility on 8/5/22 were positive for THC (a substance found in marijuana) and benzodiazepines (depressant drugs used to treat psychiatric conditions). Further review of the medical record revealed no evidence the patient was administered benzodiazepines by staff during her stay at the facility.

b. A second CIR, also dated 8/5/22, regarding the incident with Patient #22 was reviewed. According to this CIR, Patient #22 had been placed on a Line of Sight order (order where the patient must remain in sight of a staff member at all times) due to the patient disclosing intent to attempt suicide while an inpatient. Approximately seven hours later, Patient #22 was found behind closed doors by FNP #12, who reported she appeared visibly ill with severe tremors, fully dilated pupils and gray skin. The report further documented Patient #22 had previously received a skin assessment to assess for contraband by a brand new nurse (RN #16).

The CIR revealed no evidence of an investigation into the medical record revealing positive THC and benzodiazepines or the possibility of Patient #22 bringing in medications to the facility.

c. On 10/4/22 at 10:27 a.m., an interview was conducted with RN #16, who conducted the skin assessment for Patient #22 prior to the event on 8/5/22. RN #16 stated she recalled providing care for Patient #22. RN #16 further stated she had not received any recent education on the process for conducting skin assessments for suspected contraband or on providing Line of Site to patients.

d. On 10/4/22 at 11:54 a.m., an interview with FNP #12 was conducted. FNP #12 verified she had provided care for Patient #22 on the day she was transferred to a medical facility. FNP #12 further stated she had filed a CIR after the event occurred because she was concerned that Patient #22 had smuggled medications into the facility. FNP #12 stated she had questions about who conducted the skin assessment to assess if the patient was bringing in medications. FNP #12 stated she was not involved in the investigation of the incident and was not notified of the result of the investigation. FNP #12 said she was not aware of any changes made in the process of obtaining and ensuring implementation of a Line of Sight Order after the event occurred. FNP #12 further stated if she had been involved in the investigation, she could have helped by providing any further information pertaining to the incident.

e. On 10/5/22 at 9:03 a.m., an interview with DON #8 was conducted. DON #8 stated she was not aware of the positive THC and benzodiazepines documented from Patient #22's medical record at the medical facility. DON #8 further stated she had provided education on a power point presentation regarding conducting skin assessments for contraband and the process of providing Line of Sight.

However, upon review of the power point presentation, there was no evidence of education provided regarding conducting skin assessments or providing Line of Sight.

f. On 10/5/22 at 10:45 a.m., an interview with the quality assurance improvement RN (Quality RN) #17 and the quality improvement manager (Manager) #18 was conducted. Quality RN #17 stated the investigation of the incident involving Patient #22 was investigated by a physician who was no longer employed at the facility. Quality RN #17 stated due to the physician ruling out a drug overdose as the reason for the incident, there was no investigation done to see if the skin assessment conducted to assess for contraband was done correctly.

3. The facility failed to ensure critical incident reports (CIR) regarding medication errors were analyzed and that interventions were implemented in order to decrease the risk of recurrence.

a. Review of critical incident reports (CIRs) revealed medications expected to be given throughout patients' stay at the facility were not given due to the medication order expiring.

i. A CIR dated 9/3/22 regarding Patient #2 was reviewed. According to the report, Patient #2 received metoprolol (blood pressure medication) since 7/12/22. However, on 8/30/22, the medication order was discontinued. Attempts were made to restart the medication. The report further stated Patient #2's blood pressure had steadily increased, however, there were no current orders to continue metoprolol. This resulted in the patient not receiving metoprolol for five days.

Under the Quality Manager Review section of the report, documentation verified that the patient had not received metoprolol since 8/30/22. The Review documented a further attempt was made to order the metoprolol and that a Supervisory Review was sent to the director of nursing (DON) #8 and the chief medical officer (CMO). There was no further documentation noted on how the incident was resolved and what interventions were put in place to ensure the incident did not reoccur. In addition, the Supervisory Review section was blank and there was no further evidence of a review by DON #8 or the CMO.

ii. A CIR dated 9/14/22 regarding Patient #1 was reviewed. According to the report, Patient #1 had a history of swelling in the lower extremities, atrial fibrillation (irregular heart rate), and high blood pressure. The patient was ordered to receive Lasix (a medication used to help treat fluid retention), however, the order for Lasix had expired, resulting in the patient not receiving the medication for three days.

Under the Quality Manager Review section of the report, documentation revealed a physician would send an email communication regarding the expectation of all providers to review medications for all long term patients. In addition, a double check was to be added for nursing staff to check all medications. The Supervisory Review section was blank and there was no further evidence of a review by a supervisor.

b. On 9/28/22 at 3:57 p.m., an interview with family nurse practitioner (FNP) #12 was conducted. FNP #12 explained when medication orders were created, the provider placing the order was prompted to enter a date of how long the medication was to be administered. FNP #12 stated she would usually enter a date of 45 days after the order was placed since most patient visits were less than 45 days and this would ensure the patients received the medication throughout their stay.

FNP #12 then stated she noticed an increase in the frequency of medication orders being discontinued prior to patients' discharge, mostly due to a recent overall increase of the length of stay. FNP #12 stated there was no warning alert in the EMAR of when medications dropped off of the order list. FNP #12 stated there was no process in place to ensure medications intended to be administered throughout patients' stays were continued as needed and not discontinued prior to the patients' discharge. FNP #12 explained in the case of patients with long term stays, the practitioner had to be knowledgeable of the time frame for each medication order in order to assess whether or not the medications needed to be reordered. FNP #12 further stated she had not been made aware of any changes with a process to ensure medication lists were up to date.

c. On 10/4/22 at 10:27 a.m., an interview with registered nurse (RN) #16 was conducted. RN #16 stated there were no alerts in the electronic medication administration record (EMAR) for when a medication order expired due to the date entered for the order. RN #16 explained the medication would drop to the end of the list of medications to be given in the EMAR. RN #16 stated there was no process in place for ensuring medications intended to be given throughout patients' stays were continued when the order expired. RN #16 stated nurses had to be conscientious to look at the medication list to ensure the EMAR was up to date. RN #16 further stated she had not received any communication or education regarding the process of ensuring the EMAR was up to date.

d. On 9/28/22 at 2:00 p.m., an interview with the director of pharmacy (Director) #13 was conducted. Director #13 stated the prior spring she was made aware of the issue of medications dropping off of the medication list prior to patients' discharge. Director #13 then stated she was not involved in implementing any changes to the process to ensure medications were reordered prior to dropping off of the medication list.

e. On 9/28/22 at 3:23 p.m., an interview with the director of nursing (DON) #8 was conducted. She stated she provided oversight of nursing services at the facility. DON #8 stated she was aware of the issue of medication orders expiring, resulting in missed medication administration. DON #8 explained that some nurses cared for the same patients over time and should have been able to notice a difference in the amount of pills given from day to day. DON #8 then stated she was not aware of any education or process changes provided to nursing staff regarding ensuring the EMAR was up to date.

f. On 10/5/22 at 10:45 a.m., an interview with the quality assurance improvement RN (Quality RN) #17 and the quality improvement manager (Manager) #18 was conducted. Manager #18 stated supervisors were assigned to each CIR and the expectation was for the supervisor to conduct a review within five days of an incident being reported. Manager #18 verified a supervisor review had not been completed for the incident of the metoprolol not being administered. Manager #18 then stated the CMO involved with the incident had spoken with providers about the issue, however, there had been no process changes implemented to ensure medications were not dropping off of the EMAR.

4. The facility failed to ensure a CIR regarding a patient not receiving medications after being admitted.

a. A CIR dated 9/4/22 regarding Patient #18 was reviewed. Patient #18 was admitted to the facility on 9/3/22. According to the CIR, Patient #18 reported to staff that he had not received his home medications since admission. The CIR verified the medications had not been ordered at the time the CIR was created. The CIR further reported the admissions area was going to be staffed with an RN specifically assigned to the admissions department in an effort to have better completion of the medication reconciliation process.

Under the Supervisor Review section of the CIR, Quality improvement manager (Manager) #18 asked if supervision of the nurse responsible for the error could be provided. There was no evidence of supervision being provided, nor was there evidence of any staff training on the admissions process to decrease the risk of the incident recurring.

b. On 10/5/22 at 2:46 p.m., an interview with DON #8 was conducted. DON #8 verified Patient #18 missed medication due to an error that occurred in the admissions area. DON #8 stated the facility was trying to staff a dedicated RN in the admissions area, however this was not possible all of the time. DON #8 further stated there had been no education yet provided to staff regarding the medication reconciliation process.

c. On 10/5/22 at 10:45 a.m., an interview with the quality assurance improvement RN (Quality RN) #17 and the quality improvement manager (Manager) #18 was conducted. Manager #18 stated she believed medication errors were discussed at the most recent nurse staff meeting.

Review of the meeting minutes and a power point presentation from the nursing meeting on 9/19/22 and 9/22/22 revealed no evidence of medication errors being discussed at the meeting.

5. The facility failed to ensure a CIR regarding administering a medication without an order was analyzed and that interventions were implemented in order to decrease the risk of recurrence.

a. A CIR dated 9/3/22 regarding Patient #9 was reviewed. Patient #9 was admitted to the facility on 9/2/22. According to the CIR, Patient #9 received a dose of insulin without a practitioner's order. The report further documented a supervisor review was assigned to DON #8, however, the Supervisor Review section of the CIR was blank and there was no further evidence that a supervisor review had been completed.

b. On 10/5/22 at 10:45 a.m., an interview with the quality assurance improvement RN (Quality RN) #17 and the quality improvement manager (Manager) #18 was conducted. Manager #18 stated supervisors were assigned to each CIR and the expectation was for the supervisor to conduct a review within five days of an incident being reported. Manager #18 verified a supervisor review had not been completed for the incident regarding insulin administered without a practitioner's order. Manager #18 further stated she believed DON #8 provided education about medication errors in the most recent nurse staff meeting.

Review of the meeting minutes and a power point presentation from the nursing meeting on 9/19/22 and 9/22/22 revealed no evidence of medication errors being discussed at the meeting.

Based on document review and interviews, the facility failed to ensure all departments were involved in the Quality Assessment and Performance Improvement (QAPI) Program.

Findings include:

Reference:

The Quality Improvement Plan read, There are multiple dimensions to "quality" to which we attend. We are pioneering the approach to assessing a full multi-dimensional and 360-degree view of quality. Our goal is to improve all dimensions, rather than solely focusing on one at the expense of others.

1. The facility failed to ensure the emergency walk in area of the facility was incorporated into the QAPI program.

a. Review of the facility's Quality Improvement Plan revealed no evidence the emergency area, where patients presented to the facility to request care, was incorporated in the QAPI program.

Upon request of the facility's quality indicators for each department, an email was received from the Quality Improvement Manager (Manager) #18. The email reported the facility was aware of the need to improve the scope of quality indicators to reflect the complexity of services provided by the facility.

b. On 10/12/22 at 1:21 p.m., an interview with the quality assurance improvement registered nurse (Quality RN) #17 was conducted. Quality RN #17 stated the facility was not currently working on improvement data in the emergency walk in area. Quality RN #17 then stated a data point regarding the admissions and emergency area was being measured, however, the data point was not analyzed or used for any quality improvement.

Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.23 Nursing Services was out of compliance.

A-0395 A registered nurse must supervise and evaluate the nursing care for each patient. Based on record review and interviews, the facility failed to ensure nursing assessments were completed when a patient experienced a change of condition, and failed to ensure providers were notified of the change in condition in four out of four medical records reviewed of patients who experienced a physical change in condition. (Patients #5, #1, #2, and #28) (Cross-reference A-0492)

A-0405 Preparation and Administration of Drugs. (1) Drugs and biologicals must be prepared and administered in accordance with Federal and State laws, the orders of the practitioner or practitioners responsible for the patient's care, and accepted standards of practice. (i) Drugs and biologicals may be prepared and administered on the orders of other practitioners not specified under §482.12(c) only if such practitioners are acting in accordance with State law, including scope of practice laws, hospital policies, and medical staff bylaws, rules, and regulations .... (2) All drugs and biologicals must be administered by, or under supervision of, nursing or other personnel in accordance with Federal and State laws and regulations, including applicable licensing requirements, and in accordance with the approved medical staff policies and procedures. Based on record review and interviews, the facility failed to ensure medications were administered according to provider's orders in three out of seven adolescent medical records reviewed. (Patients #9, #20, and #5)

Based on record review and interviews, the facility failed to ensure nursing assessments were completed when a patient experienced a change of condition, and failed to ensure providers were notified of the change in condition in four out of four medical records reviewed of patients who experienced a physical change in condition. (Patients #5, #1, #2, and #28) (Cross-reference A-0286)

Findings include:

Facility policy:

The Nursing Provision of Care policy read, nursing staff will refer to Clinical Nursing Skills and Techniques by Perry and Potter, publisher Mosby. Nursing staff will adhere to the use of a five step process including: Assessment, nursing diagnosis, planning, implementation, evaluation. Nursing staff will observe, assess, report, and document all nursing procedures, treatments, interventions and processes and all expected and unexpected outcomes regarding provision of nursing care.

1. The facility failed to ensure nursing assessments were completed when a patient experienced a physical change in condition, and failed to report changes in condition to the provider.

a. Medical Record Reviews

i. Medical record review revealed Patient #5 had a history of chronic constipation. A nursing daily progress note from 8/31/22 at 3:34 a.m. revealed Patient #5 had complained of dizziness and abdominal pain. There was no evidence in the medical record of a physical assessment completed by nursing staff, and no evidence the patient's change in condition was reported to the provider until 9/1/22.

A nursing daily progress note from the following day (9/1/22) read Patient #5 was tearful and reported having rectal pain, hard stools, and abdominal pain. The nursing daily progress note also revealed Patient #5's bowel sounds were minimal and she had pain in her right upper abdominal quadrant when her abdomen was touched. A provider's medical progress note from 9/1/22 read Patient #5 reported vomiting four times the previous day and continued to be nauseated. The medical progress note also read Patient #5's abdomen was hard, distended, and she was guarding her abdomen and whimpering with assessment. Patient #5 was transferred to a hospital for further treatment.

ii. Medical record review revealed Patient #1 was admitted to the facility on 3/30/22 and had a history of edema (swelling), for which he took Lasix (medication used to increase urine and decrease edema) daily. On 3/31/22, documentation of the provider's physical exam read Patient #1 had edema noted to both of his mid shins and ankles which was being treated with Lasix. Documentation in the medical record also revealed Patient #1 had missed his Lasix medication on 9/12/22, 9/13/22, and 9/14/22. There was no evidence in the medical record that his edema had been assessed by nursing staff throughout his stay.

iii. Medical record review revealed Patient #2 had a history of chronic tachycardia (fast heart rate) for which he took Metoprolol (medication used to decrease heart rate and blood pressure) twice a day. Patient #2 had been administered Metoprolol on 8/30/22 at 9:25 a.m., and then the medication order expired. On 8/30/22 at 6:22 p.m., Patient #2's heart rate was documented as being 93 (normal range 60-100), with a blood pressure of 128/93 (normal less than 120/80). On 9/1/22 at 6:39 p.m., Patient #2's heart rate was documented as being 133, with a blood pressure of 141/92. There was no evidence in the medical record that Patient #2's elevated heart rate and blood pressure had been reassessed after 6:39 p.m., and no evidence the patient's change in condition had been reported to the provider.

iv. Medical record review revealed Patient #28 had a history of high blood pressure. On 8/5/22, a provider's order was placed for Hydrochlorothiazide (HCTZ) (medication that increases urine, decreases blood pressure, and decreases edema) to be administered daily.

A nursing daily progress note from 8/28/22 revealed Patient #28 had edema to both feet; 3+ (moderately severe) on the right side, and 2+ (moderate) on the left side. There was no evidence in the medical record that the patient's edema had been reported to the provider.

A provider's medical progress note from 9/19/22 read Patient #28 had chronic lower leg edema, 2+ to his lower leg. Medical record review also revealed Patient #28's order for HCTZ expired on 9/19/22 and was not renewed until 9/28/22. As a result, he missed 9 doses of HCTZ (from 9/20/22 through 9/28/22). There was no evidence the patient's edema was assessed by nursing staff in the medical record from 8/29/22 to 9/27/22.

A provider's medical progress note from 9/28/22 at 8:42 a.m. read Patient #28 had chronic lower leg edema which was 2+. However, a nursing daily progress note later the same day at 5:23 p.m. revealed Patient #28 had 3+ pitting edema to both lower legs and 2+ edema in both hands. There was no evidence in the medical record that the patient's increased edema on 9/28/22 had been reported to the provider. When seen by the provider on 9/29/22 at 3:44 p.m. the provider's medical progress note read Patient #28 had increased edema and had taut, pitting 3+ edema in his legs to his knees.

b. Interviews

i. On 10/5/22 at 11:55 a.m., an interview was conducted with registered nurse (RN) #20, who provided care for Patient #1. RN #20 stated edema assessments should have been documented in the nursing daily progress notes. RN #20 also stated Patient #1 currently had 2+ pitting edema and had indentions from his socks when he did not have indentions the week before.

There was no evidence in the medical record of the assessment RN #20 reported in the interview above, or that the patient's condition had been reported to the provider.

ii. On 10/5/22 at 2:14 p.m., an interview was conducted with director of nursing (DON) #8. DON #8 stated a nursing assessment was an educated observation. DON #8 also stated it was important for nurses to assess the current state of a patient physically and mentally to give an overall picture of the patient's physical status. Additionally, DON #8 stated nursing assessments for Patients #5, #1, #2, and #28 should have been documented in the nursing daily progress notes. However, DON #8 stated she was uncertain on how often a head to toe assessment should be completed by nursing staff at the facility.

Furthermore, DON #8 stated if a patient experienced a change in condition, the provider should have been called and a note should have been documented by the nurse that the provider had been notified. DON #8 also stated there was not a set timeframe for nurses to notify providers regarding a change in patient condition, and she was not aware of a policy that specifically discussed the topic of notifying a provider regarding a change in condition.

iii. On 10/5/22 at 1:04 p.m., an interview was conducted with family nurse practitioner (FNP) #12. FNP #12 stated a change in condition was defined as anything different from the patient's baseline. FNP #12 also stated providers trusted the nurse's judgment in letting the providers know when there was a change with a patient. Additionally, FNP #12 stated nurses were supposed to notify the providers if the patient experienced any acute issues.

iv. On 10/6/22 at 7:57 a.m., an interview was conducted with consultant (Consultant) #23, who was employed by the facility to implement process improvements. Consultant #23 stated Clinical Nursing Skills and Techniques by Perry and Potter, which was referenced in the Nursing Provision of Care policy, was a book that the nurses did not have access to. Consultant #23 stated there was not an online reference available for nurses to use.

This was in contrast with the Nursing Provision of Care policy which read nursing staff would refer to Clinical Nursing Skills and Techniques by Perry and Potter, published by Mosby.

Based on record review and interviews, the facility failed to ensure medications were administered according to provider's orders in three out of seven adolescent medical records reviewed. (Patients #9, #20, and #5)

Findings include:

Facility policies:

The Medication Administration policy read, the nurse will follow the Rights of Medication Administration: Right patient, right medication, right route, right dosage, right time, right reason, right response, right documentation. The nurse preparing and administering the medication will verify all medication labels with the medication administration record (MAR) prior to administration. If the patient was not given the medication, the following information will be documented in the medical record: Will note "refused" or "dose held" or "missed dose". The nurse will document in the details of why the medication was not given in the medical record. Medication is defined to include pharmaceutical or over-the-counter medications, drugs, supplements, vitamins, minerals, vaccines, natural and herbal products.

The Medication Orders policy read, all medications, including as needed (PRN) medications, require a valid order prior to administration for care and treatment options.

Reference:

The Medical Staff Rules and Regulations read, the Hospital requires the presence of a written or electronically completed order for all services rendered. Services will not be provided in the absence of an order.

1. The facility failed to ensure medication was administrated as ordered, consistent with facility policies.

a. Medical record review revealed Patient #9 had a history of Type 1 Diabetes Mellitus (a disorder in which the body does not produce enough, or respond normally, to insulin). On 9/2/22 at 6:21 p.m., a provider's order was placed which read Patient #9 was to receive Novolog Flexpen (insulin injections) three times a day. The injections were scheduled for 8:30 a.m., 3:00 p.m., and 9:00 p.m. On 9/3/22 at 7:44 a.m., the provider's order for insulin was changed and read Patient #9 was to receive insulin injections three times a day. The injections were scheduled to be administered at 8:00 a.m., 1:30 p.m., and 6:30 p.m. Review of the electronic medication administration (eMAR) events for 9/3/22 revealed Patient #9 was administered an additional fourth dose of insulin at 9:30 p.m., for which there was no provider's order.

Review of Patient #9's medical record also revealed that after the additional dose of insulin was administered, at 12:30 a.m., the patient's blood sugar was 90 milligrams per deciliter (mg/dL), for which she was given a nutritional drink to increase her blood sugar level. Additionally, at 5:00 a.m., her blood sugar decreased to 77 mg dL, for which she was given juice.

The fourth dose of insulin was administered in contrast to the Medication Administration policy, which read the nurse would follow the Rights of Medication Administration, including right time. This was also in contrast to the Medication Orders policy, which read all medications required a valid order prior to administration. Additionally, this was also in contrast to the Medical Staff Rules and Regulations, which read the hospital required the presence of an electronically completed order for all services rendered, and services would not be provided in the absence of an order.

i. On 10/4/22 at 2:25 p.m., an interview was conducted with registered nurse (RN) #6. RN #6 stated medication orders were prescribed prescriptions from a provider to medicate a patient, and the orders were dependent on the patient's needs. RN #6 also stated giving an additional dose of insulin was considered a medication error that could result in harm to a patient. Additionally, RN #6 stated a patient that had received an additional dose of insulin would be at risk for hypoglycemia (low blood sugar), which could become a medical emergency if the patient's blood sugar was too low.

ii. On 10/5/22 at 9:06 a.m., an interview was conducted with director of nursing (DON) #8. DON #8 stated the expectation was for nurses to have an order for a medication prior to administering it. DON #8 also stated the provider had changed the order for the insulin and the administering nurse gave the medication without a current, updated order. Additionally, DON #8 stated the nurse who administered the medication gave the medication because Patient #9 had received the insulin dose the night before the order had changed. DON #8 stated the nurse was wrong to assume the medication was still ordered for that time.

b. Medical record review revealed Patient #20 had a history of post-traumatic stress disorder (PTSD), suicidal ideations, and had aggressive and assaultive behavior. On 9/15/22 at 5:34 p.m., the provider ordered Lexapro (an antidepressant) to be administered each morning. Review of the eMAR events for 9/16/22 revealed the medication was not administered, without a reason documented as to why the dose was missed. On 9/16/22, no entry was made for the Lexapro dose on the eMAR.

This was in contrast to the Medication Administration policy, which read if the patient was not given the medication, the following information would be documented in the medical record: The nurse would note "refused" or "dose held" or "missed dose". The nurse would document the details of why the medication was not given in the medical record.

On 9/17/22 at 8:30 a.m., the nurse documented the medication as being a missed dose, with a comment that the medication was still not populating in the Pyxis (automated medication administration system). Patient #20's first dose of Lexapro was documented as being administered on 9/18/22 at 8:12 a.m., three days after the medication was ordered.

i. On 10/4/22 at 2:25 p.m., an interview was conducted with RN #6. RN #6 stated Lexapro was an antidepressant that took a while to start working. RN # 6 also stated many patients were not at the facility on a long term basis and they wanted to see if patients had adverse effects from new medications, or if patients might need the medications changed before they left the facility. Additionally, RN #6 stated by not starting new medications that had been ordered by a provider, patients could experience prolonged symptoms and have delayed treatment.

ii. On 9/28/22 at 3:24 p.m., an interview was conducted with DON #8. DON #8 stated nurses were not able to pull medications from the Pyxis if the medication had not populated in the system. DON #8 also stated she was not sure why the medication did not go through to the Pyxis, but the expectation was for nurses to notify the provider or the pharmacy staff when this occurred.

On 10/5/22 at 9:06 a.m., DON #8 was interviewed again. DON #8 stated the Lexapro would have been expected to be given the next morning after the order had been placed (9/16/22), and missing a medication was considered to be a medication error.

iii. On 9/28/22 at 2:01 p.m., an interview was conducted with Pharmacist #13. Pharmacist #13 stated medications not populating in the Pyxis happened primarily due to a miscommunication between the systems. Pharmacist #13 also stated nurses were expected to call and inform her if they were not seeing the medication populate in the Pyxis.

iv. On 10/5/22 at 1:04 p.m., and interview was conducted with family nurse practitioner (FNP) #12. FNP #12 stated if a medication was missed, the provider would need to be notified. FNP #12 stated the provider would need to give direction on what the nurse should do, as to whether or not to go ahead with administering the medication. FNP #12 stated nurses were not supposed to be making those decisions on their own. Additionally, FNP #12 stated by not starting medications that were ordered, the patient's recovery would be prolonged because the medication had to be taken to see if it was effective. Furthermore, FNP #12 stated a patient's safety risk would be extended if they had not received ordered medications because the patient could self-harm if they were suicidal.

There was no evidence in the medical record on 9/16 and 9/17/22 that the provider had been notified that Patient #20 had missed doses of Lexapro.

c. Medical record review revealed Patient #5 had a history of chronic constipation (less frequent bowel movements that are hard to pass). Milk of Magnesia (laxative) was ordered to be administered every six hours as needed. Review of the eMAR for 9/1/22 revealed Patient #5 was administered Milk of Magnesia at 11:37 a.m., and again at 1:43 p.m. There was no provider order in the medical record for the 1:43 p.m. administered dose.

The Milk of Magnesia was administered in contrast to the Medication Administration policy, which read the nurse would follow the Rights of Medication Administration, including right time. This was also in contrast to the Medication Orders policy, which read all medications required a valid order prior to administration. Additionally, this was also in contrast to the Medical Staff Rules and Regulations, which read the hospital required the presence of an electronically completed order for all services rendered, and services would not be provided in the absence of an order.

i. On 10/4/22 at 2:25 p.m., an interview was conducted with RN #6. RN #6 stated Milk of Magnesia was used for relief of constipation. RN #6 stated giving an additional dose of the medication would be considered a medication error because it was not given at the right time. Additionally, RN #6 stated the patient could be harmed if they were given too high of a dose.

ii. On 10/5/22 at 9:06 a.m., an interview was conducted with DON #8. DON #8 stated it was expected for nurses to have a provider's order prior to administering medications. DON #8 also stated it was her belief that when an additional dose of medication was given outside of normal parameters, it was acceptable to do so as long as there was documentation as to why it was administered outside of the PRN parameter.

This was in contrast to the Medication Orders policy which read, all medications, including as needed (PRN) medications, require a valid order prior to administration for care and treatment options.

iii. On 10/4/22 at 11:54 a.m. and on 10/5/22 at 1:04 p.m., interviews were conducted with FNP #12. FNP #12 stated if a medication was ordered every six hours as needed, the expectation was that it would only be given every six hours if the patient needed it. FNP #12 stated if the patient already had an order that read the medication could be given every six hours as needed, and the provider wanted an extra dose to be administered, the provider should order that dose as a one-time order, separate from the PRN order. FNP #12 stated the patient was at risk if Milk of Magnesia was administered too soon. FNP #12 stated the patient's colon could be stimulated so much that the patient could dehydrate and lose too many electrolytes which were needed for cellular function, the heart, and for breathing.

Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.25 Pharmaceutical Services, was out of compliance.

A-0492 The hospital .... must have a pharmacy directed by a registered pharmacist or a drug storage area under competent supervision .... §482.25(a)(1) - A full-time, part-time, or consulting pharmacist must be responsible for developing, supervising, and coordinating all the activities of the pharmacy services. Based on record review and interviews, the facility failed to ensure medications were administered according to provider's orders in three out of seven adolescent medical records reviewed. (Patients #9, #20, and #5)

Based on record review and interviews, the facility failed to ensure daily medications continued to be provided to patients in three out of seven medical records reviewed of patients who were admitted for more than two months. (Patients #2, #28, and #1) (Cross-reference A-0263)

Findings include:

Facility policies:

The Director of Pharmacy (DOP) policy read, the DOP assures that pharmaceutical services meet the needs of the patients of the facility. The DOP will also work directly with facility staff and within facility systems to coordinate pharmacy services and patient care. Implement policies and procedures that guide and support the provision of medication and pharmacy services. Work to resolve any interdepartmental problems.

1. The facility failed to have a process in place to ensure continuous medication orders did not automatically expire, so that daily medications were continued.

a. Medical Record Review

i. Medical record review revealed Patient #2 was admitted on 3/30/22 with a history of chronic tachycardia (fast heart rate), for which he took Metoprolol (medication used to decrease heart rate and blood pressure) twice a day. On 7/12/22, a provider reordered Metoprolol for Patient #2 with an order expiration date of 8/30/22. The electronic Medication Administration Record (eMAR) events revealed Metoprolol was administered to Patient #2 on 8/30/22 at 9:25 a.m. On 8/30/22, providers reordered and discontinued the order for Metoprolol twice. On 8/30/22 at 6:22 p.m., Patient #2's heart rate was documented as 93 beats per minute (normal range 60-100) and his blood pressure was 128/93 (normal less than 120/80).

Medical record review also revealed Patient #2's next vital signs were taken on 9/1/22 at 6:39 p.m., and he was documented as having a heart rate of 133 and a blood pressure of 141/92. Providers reordered Metoprolol again on 9/4/22 and 9/5/22. On 9/5/22 at 6:55 p.m., Patient #2 was documented as having a heart rate of 143 and a blood pressure of 130/90. The eMAR events revealed Patient #2 was administered his next dose of Metoprolol on 9/5/22 at 8:22 p.m. Patient #2 missed a total of 12 doses of Metoprolol (p.m. dose on 8/30/22, a.m. and p.m. doses from 8/31/22 to 9/4/22, and the a.m. dose on 9/5/22).

ii. Medical record review revealed Patient #28 was admitted on 7/14/22 with a history of high blood pressure. On 8/5/22, a provider's order was placed for Hydrochlorothiazide (HCTZ) (medication that increases urine, decreases blood pressure, and decreases edema) to be administered daily, with an order expiration date of 9/19/22. On 9/19/22, provider documentation read Patient #28 had chronic lower leg edema, and had 2+ (moderate) edema to his lower leg. The eMAR events revealed Patient #28 was administered HCTZ on 9/19/22 at 9:28 a.m.

Medical record review also revealed a provider reordered HCTZ for Patient #28 on 9/28/22. The eMAR events revealed Patient #28 was administered his next dose of HCTZ on 9/29/22 at 11:55 a.m. On 9/29/22, a Medical Progress Note revealed Patient #28 had increased edema and had taut, pitting 3+ (moderately severe) edema to his knees. Patient #28 missed 9 doses of HCTZ (from 9/20/22 - 9/28/22).

iii. Medical record review revealed Patient #1 was admitted on 3/30/22 with a history of high blood pressure, atrial fibrillation (irregular heart rhythm), and edema (swelling), for which he took Lasix (medication used to increase urine and decrease swelling) daily.

Medical record review also revealed, on 7/28/22, a provider reordered Lasix to be administered daily with an order expiration date of 9/11/22. The eMAR events for Patient #1 revealed Lasix had been administered on 9/11/22 at 9:02 a.m. On 9/14/22, a provider reordered Lasix to be administered daily. The eMAR events revealed Patient #1's next dose of Lasix was administered on 9/15/22 at 10:52 a.m. Patient #1 missed 3 doses of Lasix (from 9/12/22 - 9/14/22).

Interviews

i. On 9/27/22 at 8:40 a.m., an interview was conducted with Registered Nurse (RN) #19. RN #19 stated medications would drop off the medication list at the order's end date and the provider needed to reorder the medication. RN #19 also stated there were no alerts or warnings to notify facility staff that a medication was dropping off of the medication list. RN #19 stated nurses and providers tried to watch the order end dates so medications would be reordered and not missed.

RN #19 stated she was aware that a medication order for Patient #2 had dropped off resulting in missed doses of medication. RN #19 stated it had happened with Patient #2's Metoprolol, and when his heart rate and blood pressure were high, facility staff realized his Metoprolol had dropped off of the medication list.

In a second interview with RN #19 on 9/27/22 at 4:29 p.m., RN #19 stated that knowing the medications drop off of the medication list came with experience. RN #19 also stated she was hopeful that new nurses would know to watch for this issue through their training, but she was unsure if the issue was a topic covered on their training list.

ii. On 9/28/22 at 3:24 p.m., an interview was conducted with director of nursing (DON) #8. DON #8 stated medication orders needed to be reviewed for patients who were at the facility for an extended period of time to verify that medication orders had not expired.

DON #8 stated she was unsure of how facility staff would find medication orders that had expired. She said it was not common practice to look back at what medications had previously been ordered for patients but said the nurse would know if a patient was missing a medication by working with the patient on a regular basis and by being aware of what medications were given to the patient each day. Furthermore, DON #8 stated the nurse would be able to look into the medication cup and determine if the medications the patient usually took were missing.

DON #8 stated it would be difficult for new nurses to be aware of a patient's past medications. DON #8 stated she was unaware if nurses received training on expired medication orders and checking for these were not a part of their daily chart review.

iii. On 9/28/22 at 3:57 p.m., an interview was conducted with Family Nurse Practitioner (FNP) #12. FNP #12 stated she had noticed medication orders had expired and said caution had to be taken in knowing the orders were approaching their expiration dates. FNP #12 also stated there were no warnings to indicate the medication orders had expired. Additionally, FNP stated medication orders expiring happened more frequently due to patients having increased length of stays.

FNP #12 stated patients were at risk if they missed their medications. FNP #12 stated Metoprolol helped the heart not work as hard and if a patient had a history of coronary artery disease (narrowing or blockage of the arteries of the heart), putting the heart under extra stress could lead to having a heart attack. FNP #12 also stated Lasix affected a patient's electrolytes and fluid levels, and if a patient had congestive heart failure (when the heart does not pump blood effectively) and did not receive this medication, the patient could go into pulmonary edema (fluid in the lungs).

iv. On 9/28/22 at 2:01 p.m., an interview was conducted with director of pharmacy (Pharmacist) #13. Pharmacist #13 stated expired medication orders had been brought up as an issue by providers in early spring. Pharmacist #13 stated she was unsure if processes had been put in place to ensure the medications did not get missed. Pharmacist #13 stated she would notify providers if she noticed a medication order had expired, but noticing happened by chance. Additionally, Pharmacist #13 stated the pharmacy was not involved in any measures to ensure that expired medication orders did not occur.

This was in contrast to the Director of Pharmacy (DOP) policy which read, the DOP would assure that pharmaceutical services met the needs of the patients of the facility. The DOP would also work directly with facility staff and within facility systems to coordinate pharmacy services and patient care, and implement policies and procedures that would guide and support the provision of medication and pharmacy services. The DOP would also work to resolve any interdepartmental problems.

Based on record review and interviews, the facility failed to ensure all patients had individualized treatment plans based on their strengths and disabilities. Specifically, the facility failed to update treatment plans for two of two patients reviewed who experienced a change of condition, attempting to elope during hospitalization. (Patient #13 and #15)

Findings include:

Facility policy:

According to the Treatment Planning Process policy, as new information is gathered, the multi-disciplinary treatment team (MDTT) evaluates and revises goals, interventions and reflects progress towards meeting goals. The treatment plan is updated whenever new information and changes to the plan are required.

1. The facility failed to incorporate changes to the treatment plan to address two patients' change in condition while at the facility.

a. A review of Patient #13's medical record revealed the treatment plan prior to an attempted elopement on 9/1/22 was exactly the same as the follow-up treatment plan documented on 9/2/22. The follow-up plan did not address the patient's elopement risk.

b. A review of Patient #15's medical record revealed the treatment plan prior to an attempted elopement on 9/1/22 was exactly the same as the follow-up treatment plan documented on 9/2/22. The follow-up plan did not address the patient's elopement risk.

c. An interview on 10/5/22 at 8:18 a.m. with nurse practitioner (NP #4) was conducted. NP #4 stated when a patient experienced a change of condition, such as elopement attempt or other major change of functioning, the treatment plan was expected to be updated to address the change of patient need. NP #4 reported the risk to the patient was safety and prolonged hospitalization when a change in condition was not incorporated into the treatment plan.

d. An interview on 10/5/22 at 1:04 p.m. with NP #5 was conducted. NP #5 stated when a patient experienced a change of condition, such as elopement attempt or other major change of functioning, the treatment plan was expected to be updated to address the change in the patient. NP #5 further stated a change of patient condition which went unnoticed by staff placed the patient at a safety risk.

e. An interview on 10/6/22 at 8:48 a.m. with the chief medical officer (CMO #9) was conducted. CMO #9 stated it was expected any change of patient need was to be incorporated into the treatment plan. CMO #9 further stated the patient was at risk for receiving inappropriate care if the change of condition was not documented on the treatment plan.

Patient #13 and #15's treatment plans were in contrast to the Treatment Planning Process policy, which stated as new information was gathered, the MDTT evaluated and revised goals, interventions and reflected progress toward meeting goals. The treatment plan was updated whenever new information and changes to plan were required.