HospitalInspections.org

Based on interview and record review the hospital failed to ensure the medical staff provided quality of care to two of two sampled patients (Patients 1 and 2) as per the Medical Staff General Rules and Regulations as evidenced by:

1. For Patient 1:

a. Physician 1 had not dictated the progress note at or near the time of observation and did not ensure the physician's order had reflected the treatment plan written on the progress notes.

b. Physician 1 did not ensure Patient 1's informed consents for the psychotropic medications were accurate and completed as per the hospital's P&P.

c. Patient 1's Master Treatment Plan was not completed. There was no documented evidence Physician 1 attended Patient 1's IDTP team meeting.

2. For Patient 2:

a. The physician's order had not been reflected in the treatment plan written on the progress notes.

b. Physician 1 did not ensure Patient 1's informed consents for the psychotropic medications were accurate and completed as per the hospital's P&P.

c. Physician 1 did not date Patient 2's IDTP team meeting accurately.

These failures created the risk of substandard medical care to the patients in the hospital.

Findings:

Review of the hospital's Medical Staff General Rules and Regulations dated 8/23/21, showed in part:

* Progress Notes: An admitting progress note should be entered by the admitting physician, podiatrist, or designee. Sufficient progress notes shall be recorded at or near the time of observation. Whenever possible, each of the patient's clinical problems should clearly identified in the progress notes and correlated with specific orders as well as results of tests and treatments. Progress notes shall be entered at least daily on all patients by a physician of record. Physician must authenticate all progress notes by signature, date, and time.

* Gero-Psychiatric Unit:

- Medical Record: Patient's Medical records must indicate the psychiatric components of the record, including history of findings and treatment provided for the psychiatric condition for which the patient was admitted.

- Treatment Plans: Each patient must have an individual comprehensive treatment that must be based on inventory of the patient's strengths and disabilities. The plan must include a DSMV-IV TR diagnosis, short term and long-term range goals, specific treatment modalities utilized, responsibilities of member of the treatment plan, adequate documentation to justify the diagnosis, treatment, and rehabilitation carried out.

- Progress Notes: Patients shall be seen daily. Progress notes must contain recommendations or revisions in the treatment plan as indicated as well as precise assessment of the patient's progress in accordance with the original or revised treatment plans.

1. On 7/8/24 at 1143 hours, an interview and concurrent review of Patient 1's medical record was conducted with the Director of BHU.

Patient 1's medical record showed the patient was admitted to the BHU on 5/24/24 at 1344 hours and discharged on 6/11/24 at 1717 hours.

a. Review of the Consultation dictated on 5/25/24 at 1415 hours by Physician 1, showed the DOS was 5/25/24. Patient 1 was uncooperative. The patient's mood was irritated. The patient's affect was labile. The patient's speech was incoherent. The patient's thought process was loose with paranoia. The patient had verbal and physical aggression towards the staff. The treatment plan was to start the patient on olanzapine (an antipsychotic) 5 mg two times per day for acute psychosis and mood symptoms.

Review of the physician's order dated 5/25/24 at 1233 hours showed Physician 1 ordered to give Patient 1 olanzapine 2.5 mg by mouth two times per day.

Review of the Progress Note for the DOS of 5/26/24 showed Physician 1 dictated the progress note on 5/28/24 at 0450 hours (or two days later). The plan was to continue Zyprexa (same as olanzapine) titration.

Review of the Progress Note for the DOS of 5/27/24 showed Physician 1 dictated the progress note on 5/28/24 at 0451 hours (or a day later). The plan included titrating Zyprexa.

Review of the Progress Note for the DOS of 5/28/24 showed Physician 1 dictated the progress note on 6/11/24 at 0725 hours (or 13 days later). The progress note showed Patient 1 was very confused, disorganized, getting easily agitated and had mood swings and outbursts. Patient 1 was tolerating medications well without side effect. The plan was to continue medication titration.

Review of the Progress Note for the DOS of 5/29/24 showed Physician 1 dictated the progress note on 6/2/24 at 2251 hours (or four days later). The progress note showed Patient 1 remained actively manic and psychotic, was unable to care for herself with moments of agitation. The plan was to continue Zyprexa 5 mg two times per day.

However, review of the physician's orders did not show Physician 1 ordered Zyprexa 5 mg two times per day. The physician's order dated 5/19/24 at 0936 hours, showed Physician 1 ordered to give Patient 1 olanzapine 5 mg IM once for severe agitation.

Review of the Progress Note for the DOS of 5/30/24 showed Physician 1 dictated the progress note 5/30/24 at 1146 hours, showed Patient 1 remained actively psychotic and manic; and was not able to care for self with mood swings and outbursts requiring emergent medications. The plan was to increase Zyprexa 7.5 mg two times per day.

However, review of the order did not show Physician 1 ordered Zyprexa for Patient 1 as planned despite of Patient 1's behavior required an emergent IM medication due to worsening behavior. Patient 1 had been on Zyprexa 2.5 mg twice a day since 5/26/24.

Review of the Progress Note for the DOS of 5/31/24 showed Physician 1 dictated the progress note on 6/11/24 at 0726 hours (or 11 days later), showed Patient 1 was gradually improving but still with mood swings, outbursts, and delusional thoughts. The plan was to continue medication titration.

Review of the physician's order dated 5/31/24 at 1342 hours, showed to administer olanzapine 5 mg by mouth twice per day; however, this physician's order was discontinued. On 5/31/24 at 1343 hours, Physician 1 ordered to administer olanzapine 5 mg three times per day to the patient.

Review of the Progress Note for the DOS of 6/1/24 showed Physician 1 dictated the progress note on 6/11/24 at 0726 hours (or 10 days later), showed Patient 1 was gradually improving, but still with acute psychosis and agitation, The plan was to continue medication titration.

Review of the Progress Note for the DOS of 6/2/24, showed Physician 1 dictated the progress note on 6/2/24 at 2254 hours, showed Patient 1 remained actively psychotic, manic, and with poor self-care. The plan was to continue Zyprexa 7.5 mg by mouth two times per day.

However, review of the physician's orders did not show Physician 1 ordered Zyprexa 7.5 mg two times per day for Patient 1.

On 7/8/24 at 1447 hours, an interview and concurrent review of Patient 1's medical record was conducted with the Health Information Coordinator. The Health Information Coordinator verified above findings. The Health Information Coordinator verified Physician 1's progress notes did not showed Physician 1 dictated the progress note at or near the time of observation. The Health Information Coordinator was asked how the hospital had ensured the patients were seen daily. The Health Information Coordinator stated there was no monitoring for daily progress notes.

On 7/8/24 at 1455 hours, the Director of BHU verified the above findings that Physician 1's orders did not reflect the planned treatment for Patient 1.

On 7/9/24 at 1357 hours, an interview and concurrent review of Patient 1's medical record was conducted with Physician 1. Physician 1 was asked when he planned to initiate or start the planned treatment, he wrote on his progress notes for the patients. Physician 1 stated he usually started the medication on the same day after he saw his patients. Physician 1 was asked about the physician's order dated 5/25/24, showed olanzapine 2.5 mg two times per day; and the physician's note dated 5/25/24 showed treatment plan for the patient was to start the patient on olanzapine 5 mg two times per day. Physician 1 stated he might have changed his mind because Patient 1 had low platelets. Physician 1 was asked about the progress note he wrote on 5/26/24 if he documented the reason for the medication treatment plan was changed. Physician 1 verified there was no documented evidence to show the reason he changed the treatment plan for Patient 1. Physician 1 verified the physician's order did not reflect the treatment plan written on the progress note. Physician 1 was asked what the expectation would be, Physician 1 stated the expectation would be the treatment plan written on the progress notes should be the same with the orders. Physician 1 verified he did not order Zyprexa 5 mg two times per day and Zyprexa 7.5 mg two times per day as he documented on his progress note treatment plan.

b. The informed consents for the psychotropic medications were not completed for Patient 1. Cross reference to A 0131, example #1.

On 7/9/24 at 0858 hours, an interview and concurrent review of Patient 1's medical record was conducted with the Director of BHU. The Director of BHU was asked about the listed medications on the consent form. The Director of BHU stated Patient 1 was ordered for psychotropic medications, including Zyprexa, Ativan (benzodiazepine), and Restoril (benzodiazepine) only.

On 7/9/24 at 1423 hours, an interview and concurrent record review was conducted with Physician 1. Physician 1 was asked about Patient 1's Consent for Psychotropic Medication. Physician 1 stated the physician had to complete the consent form. Physician 1 stated he discussed the medications with the patient verbally; however, he acknowledged he did not mark or document that he had discussed the medication with the patient. Physician 1 stated if the patient asked for the medication information, he would mark check he provided information of the listed psychotropic medications. However, as per hospital's P&P, information of the medications should be provided for voluntary and involuntary patients admitted to the MHS. Physician 1 stated he failed to document in the medical record that Patient 1 declined to sign and refused to give voluntary consent.

c. Review of the hospital's P&P titled Treatment Plan dated 5/2023, showed in part:

* Purpose: to develop a coordinated, focused plan of care that all staff utilizes to meet the specific needs of the patient and provide optimal care.

* Policy or Procedure: Each patient admitted to the Senior Mental Health (SMH) Program shall have an individualized treatment plan with medical and psychiatric components based on the needs identified from the initial assessment, reassessment. The treatment plan includes consideration of inter-disciplinary input and is coordinated by the attending psychiatrist. The treatment planning process is continuous, beginning at the time of patient admission and continuing until discharged. Patients and families (with patient consent) are involved in selecting behavior and treatment interventions. The treatment meeting occurs no less than weekly.

* Initial Implementation:

- Upon admission, the admitting RN will review the intake documents, H&P, Nursing Initial Assessment, SMH Initial Assessment Addendum, any transfer documents if the patient was transferred from another facility and consult with admitting psychiatrist and any staff involved in the intake process. The admitting RN initiates the Interdisciplinary Plan of Care and SMH Master Problem List and IDTP.

* Interdisciplinary Team Meetings: The first IDT team meeting occurs soon after admission, at which the Inter-Disciplinary Plan Care and Master Problem List are developed, and interventions are initiated. The attendees may include the Psychiatrist, Program Manager, Nursing, Social Services and the patient and family, if available and with patient consent. When necessary, it may also include psychologist, Case Manager, Dietician, Pharmacy, and any other disciplines involved in the care of the patient. The attending Psychiatrist will chair the interdisciplinary treatment team meetings. The interdisciplinary staff will review, evaluate, and provide input to the patient's expected outcomes and interventions planned.

* Interdisciplinary Plan of Care or Master Treatment Plan: The attending Psychiatrist actively participates in developing the plan and signs after it has been formulated.

Review of Patient 1's Senior Mental Health Behavioral Health Interdisciplinary Treatment Plan dated 5/24, 5/28, and 6/4/24, showed the following:

- The Senior Mental Health Behavioral Health Interdisciplinary Treatment Plan dated 5/24/24 showed the sections of "Continued Behavioral Symptoms:", "Prior Living Situation:", "Discharge Plan:", and "Is patient able to return to prior living arrangements:" were left blank. Physician 1's signature was dated 5/25/24 (1 day after the meeting date).

- The Senior Mental Health Behavioral Health Interdisciplinary Treatment Plan dated 5/28/24, showed Physician 1's signature was dated 5/30/24 (2 days after the meeting date).

- The Senior Mental Health Behavioral Health Interdisciplinary Treatment Plan dated 6/4/24, showed Physician 1's signature was dated 6/5/24 (1 day after the meeting).

On 7/8/24 at 0900 hours, an interview was conducted with RN 1. RN 1 was asked for Physician 1's participation in the IDTP team meetings for his patients. RN 1 stated no. RN 1 stated the RN had not seen the physician participated with the IDTP team meetings.

On 7/10/24 at 1055 hours, the Director of BHU was asked for the schedule of Physician 1's IDTP meeting. The Director of BHU stated the IDTP meeting schedule was every Tuesday at 1200 hours.

On 7/8/24 at 1458 hours, an interview and concurrent record review of the Behavioral Health IDTP was conducted with the LCSW Manager. The LCSW Manager was asked about Patient 1's Behavioral Health IDTP and team meeting. The LCSW Manager stated the first encounter with Patient 1 was on 5/24/24. Physician 1 might have left for the day and might had come back the next day on 5/25/24. The patients' needs were identified on the initial IDTP and there was no team meeting. The LCSW was responsible for the discharge planning assessment. The LCSW Manager stated Physician 1 would talk to the LCSW Manager or the SW assigned to his patients if Physician 1 was not in the team meeting or Physician 1 would stop at his office to sign the IDTP. The LCSW Manager stated the SW would also call the physician.

Review of the RN notes and the LCSW notes did not show Physician 1 attended the IDTP team meetings for Patient 1.

On 7/9/24 at 0858 hours, the Director of BHU verified the above findings; and stated Physician 1 informed her that he did not attend the IDTP team meetings on 5/24, 5/28 and 6/4/24. The Director of BHU verified Physician 1 was not in attendance during the IDTP team meetings.

On 7/9/24 at 1423 hours, interview and record review was conducted with Physician 1. Physician 1 stated he attended the IDTP team meetings for Patient 1. He stated he might have stepped out of the room and attended on his patients and/or the IDTP might not be available for signing and he signed the IDTP on the following day.

However, there was no documented evidence Physician 1 was present on the days of IDTP team meetings as per the LCSW notes and the RN notes.

On 7/10/24 at 1020 hours, an interview was conducted with RN 2. RN 2 was asked if she had attended the IDTP team meeting of Physician 1's patients. RN 2 stated yes; however, Physician 1 had never attended the IDTP team meetings of his patients. There was no schedule of Physician 1's IDTP team meeting that she was aware of.

2. On 7/9/24 at 0930 hours, an interview and concurrent review of Patient 2's record review was conducted with the Director of BHU.

Patient 2's medical record showed Patient 2 was admitted voluntarily to the BHU on 6/26/24 at 2315 hours, for severe worsening psychosis, delusions, and agitation.

Review of the Consultation dictated on 6/27/24 at 1309 hours for the DOS of 6/27/24, showed Patient 2 was observed talking to the wall and to unseen others, not making any sense. Patient 2 was uncooperative. The patient was irritable. The treatment plan was to resume Risperdal (an antipsychotic) 1 mg two times per day for acute psychosis.

Review of the physician's order dated 6/27/24 at 0047 hours, showed Physician 1 ordered to give Patient 2 lorazepam (same as Ativan) 0.5 mg by mouth every six hours as needed for agitation or anxiety. There was no order for Risperdal 1 mg two times per day for acute psychosis as per the treatment plan.

Review of the Progress Note for the DOS of 6/28/24 showed Physician 1 dictated the progress note on 6/28/24 at 1039 hours. The plan was to start the patient on 5150 holds for grave disability, continue to encourage the patient to remain in adherent to her medication, and review the risk, benefits, and alternatives.

Review of the physician's order did not show Physician 1 ordered Risperdal for the patient.

Review of the Progress Note for the DOS of 6/29/24 showed Physician 1 dictated the progress note on 7/1/24 at 0656 hours (two days later). The patient was still very delusional and bizarre, very restless, and anxious, and actively hallucinating. The plan was to continue Risperdal titration and increase it to three times per day.

Review of the physician's order dated 6/29/24 at 1112 hours, Physician 1 ordered risperidone (same as Risperdal) 1 mg by mouth three times per day.

Review of the Progress Note for the DOS of 6/30/24 showed Physician 1 dictated the progress note on 7/1/24 at 0658 hours (one day later). Patient 1's Risperdal had now been increased to three times per day. The patient appeared to be tolerating it well. Physician 1 discussed about long-acting injectable to Patient 2, but the patient continued to be very delusional, getting increasingly agitated for no reason. The plan was to continue to discuss risk, benefits, and alternative of a long- acting injectable.

Review of the Progress Note for the DOS of 7/1/24 showed Physician 1 dictated the progress note on 7/2/24 at 0737 hours (one day later). Patient 2 remained very delusional and bizarre. The plan was to continue titration of Risperdal.

Review of the Progress Note for the DOS of 7/2/24 showed Physician 1 dictated the progress note on 7/3/24 at 1211 hours (one day later). Patient 2 would sometimes take her antipsychotic medications, sometimes would refuse. The patient signed for voluntary admission.

Review of the Progress Note for the DOS of 7/3/24 at 0845 hours showed Physician 1 electronically signed on 7/9/24 at 1036 hours. Patient 1 remained selective with medications, but staff reported the patient had better adherence with meals and food.

The Director of BHU verified the above finding; the progress note dictation was late and the physician's orders did not reflect Physician's 1's treatment plan documented on progress notes with his orders.

On 7/9/24 at 1435 hours, an interview and concurrent record review was conducted with Physician 1. Physician 1 verified the above findings.

b. The informed consents for the psychotropic medications were not completed for Patient 2. Cross reference to A 0131, example # 2.

On 7/9/24 at 1423 hours, an interview and concurrent record review was conducted with Physician 1. Physician 1 was asked about Patient 2's Consent for Psychotropic Medication. Physician 1 stated he discussed the medications with the patient. However, he acknowledged he did not mark or document that he had discussed the medications with the patient. Physician 1 stated the patient would be provided of the listed psychotropic medication information if the patient asked or requested for it. However, as per hospital's P&P, information of the medications should be provided for voluntary and involuntary patients admitted to the MHS. When asked if he documented on his progress note Patient 2's refusal to sign the informed consent for the use of psychotropic medication, Physician 1 stated he failed to document on his notes that Patient 2 declined to sign and refused to give voluntary consent.

c. Review of Patient 2's Senior Mental Health Behavioral Health Interdisciplinary Treatment Plan showed the Psychiatrist, Nursing, LCS, and Activity Therapist signed the form on 6/27/24.

The Director of BHU was asked about the IDTP team meeting on 6/26/24 for Patient 2. The Director of BHU stated the nursing staff had initiated the MTP when the patient was admitted on 6/26/24 at 2313 hours. However, the LCSW showed had seen and evaluated Patient 2 on 6/27/24.

On 7/9/24 at 1435 hours, interview and concurrent record review was conducted with Physician 1. Physician 1 verified he did not meet with the IDTP team on the night of 6/26/24. However, the IDTP showed Physician 1 signed the form on 6/26/24.

Based on interview and record review, the hospital failed to ensure the informed consents to receive psychotropic medications were obtained for two of two sampled patients (Patients 1 and 2). This failure had the potential for the patients and/or the patients' responsible parties not being allowed to make medical care decisions.

Findings:

Review of the hospital's P&P titled Informed Consent for Psychotic/Psychotropic medications dated 9/2023, showed the following:

* Scope: All prescribing Psychiatrist

* Purpose: To provide a system of informed consent for those patients receiving antipsychotics or psychotropic medications.

* Psychotropic medications or drugs are those medications administered for the purpose of affecting the central nervous system to treat psychiatric disorder or illnesses. These medications include, but not limited to anxiolytic agents, antidepressants, mood stabilizers, antipsychotic medications, antiparkinson agents, hypnotics, medications for dementia, Alzheimer's, and psychostimulants.

* Policy: It is the policy that all persons who are voluntary or on an involuntary hold (5150, 5250, 5260, 5270), who are receiving medications for their psychiatric condition, are given both oral and written information about the medication. The procedure will apply to all hospital in patients who will be prescribed and/or administered antipsychotic or psychotropic medication by their treating psychiatrist. The patient is given information regarding the medication by the psychiatrist who obtains the patients signature on the consent form.

* Procedure:

- Every patient who will be prescribed an antipsychotic or psychotropic medication or an adjunctive medication, directly related to the treatment of the patient's mental disorder, shall have the content of the appropriate informed consent form discussed with him or her by the prescribing psychiatrist.

- The psychiatrist shall enter on the form the specific medication, the dosage range of the medication to be prescribed or administered, and the date of discussion. Subsequent changes in doses within the specific range will not require a new informed consent.

- After the psychiatrist has discussed the recommended medication, nature and effect and the patient indicates understanding the content of the informed consent, the patient shall sign and date the consent form showing that he or she agrees to the administration of the recommended medications.

- In the event that the patient has been shown but refused to sign the informed consent, it shall be sufficient for the psychiatrist to place the unsigned consent into the patient's chart together with a notation in the medical record that while the patient understands the nature and effect of the medication, the patient declines such medications and refuses to give voluntary consent.

1. On 7/9/24 at 0858 hours, an interview and concurrent review of Patient 1's medical record was conducted with the Director of BHU.

Patient 1's medical record showed Patient 1 was admitted to the hospital on 5/24/25.

Review of Patient 1's Medication Consent Sheet showed the patient would receive eight psychotropic medications including Risperdal, Depakote (an anticonvulsant or mood stabilizer), Ativan, Restoril, Seroquel (an antipsychotic), Zyprexa, Aricept (a medication used to treat Alzheimer), and Namenda (a medication used to treat Alzheimer). The section of the Patient/Conservator's Signature was left blank for eight psychotropic medications listed. The boxes of "I have not disclosed the risks related to the proposed medication to the Patient (or their surrogate) ..., but I have provided other information material:", "As part of this consent process the Patient and/or their surrogate have been provided information sheets for the above listed medications" were not checked.

The Director of BHU stated the Medication Consent Sheet was not completed for Patient 1. Patient 1 refused to sign the consent. Physician 1 was responsible to obtain the consent from the patient. The Director of BHU verified the consent did not show the medications were reviewed with the patient and did not show the medication information had been provided to the patient. The Director of BHU was asked to show documented evidence that Physician 1 discussed the medications with Patient 1. The Director of BHU stated Physician 1 failed to show on his notes that he had discussed the psychotropic medications listed on the consent with the patient, the patient refused to sign the consent, and the patient verbalized of willing to take medications. The physician should have documented on his notes the risks and benefits were discussed with the patient. Patient 1 was taking her psychotropic medications on and off. The nurses could still offer the medications and some patients would take their medications without signing the consent.

On 7/10/24 at 0900 hours, an interview and concurrent record review of Patient 1's MAR was conducted with the Director of BHU.

Review of the MAR showed Patient 1 received the following psychotropic medications without informed consent:

- Restoril 15 mg on 5/26/24 at 2225 hours, 5/28/24 at 0156 hours, and 5/28/24 at 2308 hours.

- Ativan 0.5 mg on 5/24/24 at 1547 hours, 5/25/24 at 1215 and 2300 hours, 5/26/24 at 2054 hours and 5/27/24 at 2213 hours.

- Zyprexa 2.5 mg on 5/25/24 at 1344 and 2047 hours, 5/26/24 at 0816 and 2111 hours, 5/27/24 at 2052 hours, and 5/28/24 at 0839 and 2148 hours.

2. On 7/9/24 at 0930 hours, an interview and concurrent review of Patient 2's medical record were conducted with the Director of BHU.

Patient 2's medical record showed Patient 2 admitted to the hospital on 6/26/24.

Review of Patient 2's Medication Consent Sheet showed the patient would receive six psychotropic medications, including Risperdal, Depakote, Ativan, Restoril, Zyprexa, and Seroquel. The section of Patient/Conservator Signature was left blank for six psychotropic medications listed. The boxes of "I have not disclosed the risks related to the proposed medication to the Patient (or their surrogate) ..., but I have provided other information material:", "As part of this consent process the Patient and/or their surrogate have been provided information sheets for the above listed medications" were not checked.

The Director of BHU stated the Medication Consent Sheet was not completed for Patient 2. Patient 2 refused to sign the consent. The Director of BHU verified the consent did not show the medications were reviewed with the patient and did not show the medication information had been provided to the patient. The Director of BHU was asked to show documented evidence that Physician 1 had discussed the medications with Patient 2. The Director of BHU stated Physician 1 failed to show on his notes that he had discussed the psychotropic medications listed on the consent with the patient, the patient refused to sign the consent, and the patient verbalized of willing to take medications. The physician should have documented on his notes the risks and benefits were discussed with the patient. Patient 2 was taking her psychotropic medications on and off per nursing notes.

On 7/10/24 at 0900 hours, an interview and concurrent record review of Patient 1's MAR was conducted with the Director of BHU.

Review of the MAR showed Patient 2 received the following psychotropic medications without informed consent:

- Restoril 7.5 mg on 6/27/24 at 2304 hours.

- Ativan 0.5 mg on 6/27/24 at 0056 and 1327 hours, 6/28/24 at 2335 hours, and 6/29/24 at 0917 hours.

- Risperdal 1 mg on 6/29/24 at 1433 and 2035 hours.

On 7/10/24 at 1020 hours, a tour of the BHU was conducted with the Director of the BHU. RN 2 was asked what the RN would do if the patient refused to sign the consent for psychotropic medications. RN 2 stated she was informed that the nurses could offer the psychotropic medication and document on the patient's chart with another nurse to sign as a witness that patient agreed verbally to take the medication.

On 7/10/23 at 1300 hours, the Director of BHU stated as per the County's Mental Health Patient Rights Advocate the nurse should get a verbal consent from the patient with another nurse to witness and attempt to get the patient to sign the consent few days later.

Based on interview and record review, the hospital failed to ensure the hospital's QAPI activities affecting the patient care contained plan of action to prevent further events and promote sustained improvement, and the report of the QAPI monthly meetings were sent to the MEC and/or the Governing Board as per the hospital's P&P. This failure had the potential in the hospital's ability to ensure the provision of quality health care in a safe environment.

Findings:

Review of the hospital's P&P titled Organization-Wide Quality Assessment And Performance Improvement Program dated 03/2024, showed the following:

* Purpose: The Organizational Quality Assessment and performance Improvement Plan is designed to provide systemic and organized program for the promotion of safe, quality patient care and services. Activities are interdisciplinary and collaborative in order to respond to the needs of the customer, patient, physician, employee, and community. Through an interdisciplinary and integrated process, patient care and processes that effect patient care outcomes shall be continuously monitored and evaluated to promote optimal achievements, with appropriate accountability assumed by the Governing Board, Medical Staff, administration, and support personnel. QAPI activities will be integrated across all the care and service areas of the organization. On an annual basis and as needed, a Facility Assessment will be conducted to include an overview of the services and care areas that are provided. To prevent further events and promote sustained improvement the organization develops action plans to address the identified root causes and/or contributing factors of an issue/event that will effect changes at the systems level.

* Goals of the Quality Improvement program are as follows:

- To improve the quality, safety and reliability of patient care processes and outcomes.

- To promote patient safety by prevention and reduction of medical errors.

- To integrate the principles of high reliability into the quality structure and culture.

- To enhance communication between the Medical Staff, Hospital Department/Services, and the Governing Body regarding the conclusions and recommendations resulting from data analysis and the actions taken to address the findings and recommendations.

* Participation in Quality Improvement activities are the responsibility of everyone employed by, on the medical staff of, or contracted with the hospital. The organizational plan for Quality is reviewed and approved annually by the Quality/Patient Safety Committee, MEC, and Governing Board.

* The Governing Board shall be responsible to ensure the provision of optimal quality care, safety, and organization wide. The board is ultimately accountable for the safety and quality of patient care and service of the hospital and has legal responsibility in every department and service of the hospital and has legal responsibility and operational authority for hospital performance. While maintaining overall responsibility, the Board delegates operational responsibility to the Medical Staff and Administration. The Board shall facilitate Quality Improvement by:

- The Governing Board authorizes the establishment of a committee structure to implement the QAPI program; ensure the quality program reflects the complexity of the hospital's organization and services.

- Approve the QAPI plan.

- Provide adequate resources, both material and manpower, to accomplish the QAPI function.

- Receives reports of QAPI data from all departments and services of the hospital including those provided through contracts.

- Reviewing, accepting, or rejecting periodic action plans based on findings, actions, and results of program activities regarding the effectiveness of organization-wide quality and safety activities.

- Assuring clear expectations for safety are established; and providing a mechanism in which the Chief of the Medical Staff (the individual assigned the responsibility for the organization and conduct of the hospital's medical staff.)/designee to consult no less than twice a year with the Board of Trustees regarding the quality of care provided to the patients of the hospital.

* Medical Executive Committee (MEC) and the organized Medical Staff.

- The Medical Executive Committee, accountable to the Board, has the primary authority for activities related to self-governance of the medical staff and for performance improvement of the professional services provided by licensed independent practitioners and other practitioners privileged through the medical staff process. The MEC makes recommendations directly to the governing body based on the conclusion of the MEC's review of QAPI reports from medical staff committees, departments, and other assigned activity groups.

- The organized medical staff identifies and analyzes problems and opportunities, recommends actions to the MEC, and monitors the effect of the actions taken to determine that problems have been resolved; reports Medical Staff related quality indicators/data results through the Quality/Patient Safety Committee structure, then to the MEC and Board by way of written reports and summaries.

* Senior leadership supports the maintenance of the QAPI process through allocation of staff and sources necessary to fulfill the requirements of the program.

* Quality and Regulatory Compliance department shall be responsible to support the organizations' Quality Improvement principles, strategies, priorities, approach, and methodologies which includes but is not limited to the following tasks:

- Works with the Medical Staff, and all hospital departments/services, and teams to effectively measure, assess, analyze, and improve the quality of care and services.

- Works with the Medical Staff Leadership and hospital leadership to prepare an annual organization-wide evaluation of the Quality Program.

* The department leaders are accountable for the quality and safety of care/services and performance of their staff and departments. The department Directors will monitor, analyze, and report the processes in their areas that effect patient care, safety, outcomes, and satisfaction.

* Quality/Patient Safety Committee: Membership includes but is not limited representative from both clinical and non-clinical areas including the Medical Staff, Senior Leadership (CEO, CNO, CQO, CFO), Quality Coordinator, Risk Management/Patient Safety Officer, and other clinical and non-clinical staff as appropriate on as ad hoc basis. Activities include assisting the Governing Board and MEC with evaluating the effectiveness of the QAPI activities of the hospital departments/services and teams; assisting the Governing Board and MEC with evaluating and validating corrective action has resulted in improvement; and maintaining records of committee proceedings.

* Quality and Patient Safety Integration: Reports the results of monitoring activities and the improvement action plans as appropriate to the Medical Executive Committee and Governing Board at the frequency specified by the Governing Board.

On 7/10/24 at 1105 hours, upon request, the hospital provided documents titled Quality/Pt Safety Council, and the dashboards dated April 8, May 28, and June 25, 2024, were reviewed with the CQO.

The monthly QAPI reports dated 4/23, 5/28, and 6/25/24, showed "all fallouts were discussed, and/or there was no data available-deferred".

However, there was no documented evidence to show action plans to prevent further events, to address the identified root cause and/or contributing factors, and to promote sustained improvement as per the hospital's P&P.

On 7/10/24 at 1440 hours, an interview with concurrent record review was conducted with the CNO and CQO.

When asked as a member of the QAPI how the quality of care and the effectiveness of the action plans were monitored to prevent further events and sustained improvements. The CNO stated the quality of care was ensured through the monthly QAPI team meetings, and the daily huddles. The CNO was informed the QAPI reports reviewed (May, June, & July 2024) did not show an action plan to prevent further events. The CNO did not respond. The CNO was asked how the monthly QAPI meetings information reached the MEC and the Governing Board. The CNO stated a physician member of the MEC chaired the QAPI meetings and the chair would share the report of the meeting with the MEC team members. When asked how this information reached the Governing Board, the CQO stated the Administrative Staff Secretary sent the monthly meeting minutes to the Medical Staff Director's office to forward to the Governing Board. When asked to provide a copy of the monthly QAPI report for May, June and July 2024 forwarded to the Governing Board as per the hospital's P&P, the CQO stated per the administrative secretary the reports have not been received by the respective office to be forwarded to the MEC team and/or the Governing Board. The CNO and the CQO verified the findings.

Based on interview and record review, the hospital failed to ensure the Ongoing Professional Practice Evaluation was completed for one of two physicians (Physician 1) credential files reviewed as per the hospital's P&P. This failure posed an increased risk of substandard health outcomes to the patients.

Findings:

Review of the hospital's Medical Staff Bylaws adopted on 11/22/21, showed the section of Focused Professional Practice Evaluation (FPPE) - Initial Members and Members Granted New Clinical Privileges showing the following:

* Except as otherwise recommended by the Medical Executive Committee and approved by the Governing Board, all practitioners initially appointed to the medical staff and all members granted new clinical privileges, shall be subject to a period of focused professional practice evaluation.

* The chair of the department, or the chair's designee(s), shall conduct the evaluation in accordance with criteria specified in the department's rules and regulations and approved by the Medical Executive Committee. Each member requesting new clinical privileges shall undergo the same evaluation by the appropriate department(s) to determine eligibility to exercise the clinical privileges requested.

* The practitioner shall remain subject to such evaluation as specified in the department's rules and regulations, until the Medical Executive Committee has been finished with the following:

- A report signed by the chair of the department(s) to which the member is assigned describing the types and numbers of cases observed and the evaluation of the practitioner's performance, a statement that the practitioner appears to meet all of the qualifications for unsupervised practice in that department, has discharged all of the responsibilities of staff membership, and has not exceeded or abused the prerogatives of the category to which the practitioner was made, and meets the qualifications to continue to exercise the new clinical privileges initially granted in that department.

Review of the hospital's P&P titled Professional Practice Evaluation - Ongoing (OPPE) and Focus (FPPE), reviewed date 11/19/21, showed the following:

* Scope: Medical Staff and Allied Health Professional Members, Medical Staff Services and Quality Management Departments.

* Purpose: To ensure the Medical Staff, through its activities, assesses the professional practice and competence of its members via a systemic process that is clearly defined, objective, equitable, defensible, timely and useful.

* The Ongoing Professional Practice Evaluation (OPPE) is an adjunct program to the current peer review process which provides the medical staff with the ability to identify professional practice trends that impacts quality of care and patient safety on an ongoing basis. The program includes:

- The evaluation of a practitioner's professional performance includes opportunities to improve care based on recognized standards

- Uses multiple sources of information, including but not limited to the review of aggregate data, compliance with hospital's policies, the rules and regulations and the Bylaws of the Medical Staff, recognized clinical standards and the use of rates compared against established benchmarks or norms.

- Individual evaluation is based on generally recognized standards of care. This process provides practitioners with feedback for personal improvement or confirmation of personal achievement related to the effectiveness of their professional, technical and interpersonal skills in providing patient care.

* The Focused Professional Practice Evaluation (FPPE) is a process initiated when the OPPE results raise questions/concerns regarding a currently privileged practitioner's ability to provide safe, high quality patient care.

- The proctoring program, for initial and new privileges, as defined in each Medical Staff Department's Rules and Regulations is a component of the FPPE program.

* The OPPE is based on six areas of general competency:

- Patient Care
- Medical/Clinical Knowledge
- Practice Based Learning Environment
- Interpersonal and Communication Skills
- Professionalism
- System Based Practice

* The OPPE shall be conducted for all practitioners with clinical privileges. Reviews shall be conducted at eight months, 16 months, and 24 months from the practitioner's appointment date or last reappointment date by the governing Board.

* Monthly, the Medical Staff Office will prepare an OPPE Report for each practitioner scheduled for review. Data will be collected, collated, and transcribed onto the report.

* Each practitioner's OPPE report will be maintained in the Medical Staff Office and will be incorporated with the practitioner's reappointment information.

On 7/9/24 at 0905 hours, interview and concurrent record review was conducted with the hospital's Medical Staff Director.

Review of Physician 1's credential file showed Physician 1 was granted hospital privileges as of 3/28/23. When asked for the practitioner's OPPE documentation, the Medical Staff Director stated no documented reports were available.

On 7/10/24 at 1000 hours, the findings were shared with the Chief Quality Officer and the Quality Director.

On 7/10/24 at 1025 hours, an interview was conducted with Physician 2. When asked about the ongoing performance evaluation of Physician 1 in relation to the documentation, rounding, attending the weekly treatment plan meeting, ordering the psychotropic medication orders, and obtaining informed consent. Physician 2 stated Physician 2 was not aware of any issues regarding to Physician 1's performance on the unit. When asked about the hospital's P&P regarding to the ongoing performance evaluation of a recently privileged practitioner, Physician 2 stated the physician would be notified by the hospital's Medical Staff regarding proctoring a recent privileged provider. Physician 2 also stated "I'm not proactive, I'm reactive." When asked, Physician 2 stated he would review three medical records of Physician 1's patients and submit an evaluation to the Medical Staff.