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5201 WHITE LANE

BAKERSFIELD, CA 93309

PATIENT RIGHTS: INFORMED CONSENT

Tag No.: A0131

Based on interview and record review, the hospital failed to:

1. Obtain informed consents (process in which patients are given important information, including possible risks and benefits, about a medical procedure or treatment) from the family members (FM 2 and FM 3) for two of two minor sampled patients (Patient 4 and Patient 5) prior to administration of psychotropic medications (medications that affect the mind, emotions, and behavior). This failure resulted in Patient 4 and Patient 5 receiving medications without knowing the risks, benefits, and alternatives of the drugs and without FM 2 and FM 3 being aware of the medications prescribed and administered to their minor children.

2. Obtain informed consent for Condition of Admissions and Treatment for one of 10 sampled patients (Patient 6). This failure had the potential for patients' wishes to not be honored, and for patients to not receive the opportunity to exercise their rights to make decisions over their health.

Findings:

1. During a concurrent interview and record review on 9/18/24 at 2:51 p.m. with Quality/Risk Registered Nurse (QRRN), Patient 4's Physician's Orders (PO), dated 9/13/24, were reviewed. The PO indicated, "Abilify (medication to decrease hallucinations [false perception of objects or events])15 mg (milligrams) one tablet at bedtime for bipolar (a mental illness that causes unusual shifts in a person's mood, energy), Trileptal (medication to treat seizures) 300 mg one tablet daily in the morning and 600 mg one tablet at bedtime for bipolar, Vistaril (medication used to help control anxiety and tension) 25 mg one tablet three times a day PRN (as needed) for anxiety, and Wellbutrin (medication to treat depression) SR (slow release) 100 mg one tablet at bedtime." QRRN stated Patient 4 came in with suicidal ideation (thinking about killing one's self) with a plan.

During a concurrent interview and record review on 9/18/24 at 2:55 p.m. with Interim Chief Nursing Officer (ICNO), Patient 4's Informed Consent for Abilify, dated 9/13/24, was reviewed. The informed consent form for Abilify 15 mg did not indicate the name of FM 2 as giving the consent to administer Abilify 15 mg one tablet orally at bedtime. The informed consent form for Ability 15 mg indicated two healthcare workers, a physician, and a registered nurse signed Patient 4's informed consent form on 9/13/24. ICNO stated she was unable to find documentation FM 2 had been contacted to give consent to administer Abilify 15 mg orally at bedtime to Patient 4.

During a concurrent interview and record review on 9/18/24 at 3 p.m. with ICNO, Patient 4's Informed Consent for Trileptal 300 mg and Trileptal 600 mg, dated 9/13/24, were reviewed. The informed consent form for Trileptal 300 mg and Trileptal 600 mg did not indicate the name of Patient 4's FM 2 as giving the consent to administer Trileptal 300 mg one tablet daily in the morning and Trileptal 600 mg one tablet at bedtime. The informed consent form for Trileptal 300 mg and Trileptal 600 mg indicated two healthcare workers, a physician, and a registered nurse signed the informed consent form on 9/13/24. ICNO stated she was unable to find documentation FM 2 had been contacted to give consent to administer Trileptal 300 mg in the morning and Trileptal 600 mg at bedtime to Patient 4.

During a concurrent interview and record review on 9/18/24 at 3:05 p.m. with ICNO, Patient 4's Informed Consent for Wellbutrin SR 100 mg, dated 9/13/24, was reviewed. The informed consent form for Wellbutrin SR 100 mg did not indicate the name of Patient 4's FM 2 as giving the consent to administer Wellbutrin SR 100 mg one tablet every morning. The informed consent form for Wellbutrin SR 100 mg indicated two healthcare workers, a physician, and a registered nurse signed the informed consent form on 9/13/24. ICNO stated she was unable to find documentation FM 2 had been contacted to give consent to administer Wellbutrin SR 100 mg one tablet in the morning to Patient 4.

During a concurrent interview and record review on 9/18/24 at 3:10 p.m. with ICNO, Patient 4's Informed Consent for Vistaril 25 mg, dated 9/13/24, was reviewed. The informed consent form for Vistaril 25 mg tablet did not indicate the name of Patient 4's FM 2 as giving the consent to administer Vistaril 25 mg tablet orally three times a day PRN for anxiety. The informed consent form for Vistaril 25 mg indicated two healthcare workers, a physician, and a registered nurse signed the informed consent form on 9/13/24. ICNO stated she was unable to find documentation FM 2 had been contacted to give consent to administer Vistaril 25 mg three times a day as needed for anxiety to Patient 4.

During a review of Patient 4's Medication Administration Record (MAR), dated 9/13/24 and 9/14/24, the MAR indicated the following:

Abilify 15 mg PO (orally) given on 9/13/24 at 9 p.m.
Trileptal 600 mg PO given on 9/13/24 at 9 p.m.
Trileptal 300 mg PO given on 9/14/24 at 9 a.m.
Wellbutrin SR 100 mg PO given on 9/14/24 at 9 a.m.

During a concurrent interview and record review on 9/18/24 at 3:20 p.m. with ICNO, Patient 5's Physician's Orders, dated 9/12/24, were reviewed. The Physician's Orders indicated the following psychotropic medications: Prozac (treats major depressive disorder [MDD-a mental health disorder characterized by persistently depressed mood or loss of interest in activities]) 40 mg by mouth every day, Latuda (treats MDD) 60 mg one tablet by mouth at bedtime, Hydroxyzine (treats anxiety) 25 mg by mouth three times a day PRN for anxiety, and Trazodone (used to treat depression) 50 mg by mouth every HS (at bedtime) PRN for insomnia.

During a concurrent interview and record review on 9/18/24 at 3:25 p.m. with ICNO, Patient 5's Informed Consent for Prozac 40 mg, dated 9/12/24, was reviewed. The informed consent form for Prozac 40 mg tablet did not indicate the name of Patient 5's FM 3 as giving the consent to administer Prozac 40 mg by mouth every day for MDD. The informed consent form for Prozac 40 mg indicated two healthcare workers, a physician, and a registered nurse signed the informed consent form on 9/12/24. ICNO stated she was unable to find documentation FM 3 had been contacted to give consent to administer Prozac 40 mg by mouth daily to Patient 5.

During a concurrent interview and record review on 9/18/24 at 3:30 p.m. with ICNO, Patient 5's Informed Consent for Latuda 60 mg, dated 9/12/24, was reviewed. The informed consent form for Latuda 60 mg tablet did not indicate the name of FM 3 as giving the consent to administer Latuda 60 mg by mouth at bedtime. The informed consent form for Latuda 60 mg indicated two healthcare workers, a physician, and a registered nurse signed the informed consent form on 9/12/24. ICNO stated she was unable to find documentation FM 3 had been contacted to give consent to administer Latuda 60 mg by mouth at bedtime to Patient 5.

During a concurrent interview and record review on 9/18/24 at 3:35 p.m. with ICNO, Patient 5's Informed Consent for Hydroxyzine 25 mg, dated 9/12/24, was reviewed. The informed consent form for Hydroxyzine 25 mg tablet did not indicate the name of Patient 5's FM 3 as giving the consent to administer Hydroxyzine 25 mg by mouth three times a day PRN for anxiety. The informed consent form for Hydroxyzine 25 mg indicated two healthcare workers, a physician, and a registered nurse signed the informed consent form on 9/12/24. ICNO stated she was unable to find documentation FM 3 had been contacted to give consent to administer Hydroxyzine 25 mg by mouth three times a day PRN for anxiety to Patient 5.

During a concurrent interview and record review on 9/18/24 at 3:40 p.m. with ICNO, Patient 5's Informed Consent for Trazodone 50 mg, dated 9/12/24, was reviewed. The informed consent form for Trazodone 50 mg tablet did not indicate the name of Patient 5's FM 3 as giving the consent to administer Trazodone 50 mg by mouth every HS PRN for insomnia (difficulty sleeping). The informed consent form for Trazodone 50 mg indicated two healthcare workers, a physician, and a registered nurse signed the informed consent form on 9/12/24. ICNO stated she was unable to find documentation FM 3 had been contacted to give consent to administer Trazodone 50 mg by mouth every HS PRN for insomnia to Patient 5.

During an interview on 9/19/24 at 10:22 a.m. with Physician (MD) 2, MD 2 stated he called Patient 4's FM 2 and Patient 5's FM 3, MD stated he did not document the family member's names. MD 2 stated the FM's were not entered on the informed consent forms of the prescribed antipsychotic medications.

During a review of the facility's policy and procedure (P&P) titled, "Consent to Psychotropic Medications," dated 9/5/23, the P&P indicated, "1. On admission and prior to administration of medication, the provider who orders the medication obtains consent ...8. Nurses may not administer psychotropic medication to any patient without a signed consent form ..."

During a review of the facility's "Clinical Documentation Training Manual," dated 2024-2025, the Training Manual indicated, "Informed Consent: Psychotropic medications treatment is not one of the sensitive services that a minor can consent to. Parent/guardian consent is required if psychotropic medications are prescribed."

2. During a concurrent interview and record review on 9/18/24 at 3:40 p.m. with ICNO, Patient 6's Condition for Admission and Consent for Treatment, dated 9/16/24, were reviewed. The Condition for Admission and Condition for Treatment consent forms for Patient 6's consents were not signed. ICNO stated there were no attempts by staff to obtain Patient 6's consent for admission and treatment.

During a review of the facility's "Clinical Documentation Training Manual," dated 2024-2025, the Training Manual indicated, "Adults, including those receiving behavioral health treatments have the right to give or refuse consent to medical diagnostic or treatment procedures. California Health and Safety Code 7185.5(a) states that 'legislature finds that adult persons have the fundamental right to control the decisions relating to the rendering of their own medical care. California Code of Regulations Title 22 70707(b)(6) provides that a person has a right to participate actively to decisions regarding medical care."

Staffing Requirements

Tag No.: A1615

Based on interview and record review, the hospital failed to:

1. Ensure the Program Coordinator (PC) had the competency and the qualification to manage the Incompetent to Stand Trial [IST] Unit in Units 500, 600, and 700 designed to train and educate the patients regarding processes in court proceedings. This failure had the potential to result in the PC not being able to provide the necessary leadership and management skills necessary to run an efficient and effective IST Unit.

2. Ensure nine of 10 employees (Quality Risk Registered Nurse [QRRN], PC, two MHW, ( MHW 1 and MHW 2), and five Registered Nurses (RN 1, RN 2, RN 3, RN 4, and RN 5) received training on Emergency Preparedness. This failure had the potential for patients and staff to be unsafe in the event of an emergency.

3. Ensure three of 10 employees (PC, MHW 1 and MHW 2) received training on Infection Control. This failure had the potential for patients and staff to be exposed to infections and transmit infectious diseases.

Findings:

1. During a concurrent interview and record review on 9/18/24 at 3 p.m. with Interim Chief Nursing Officer (ICNO), the IST Case Manager's Personnel File (CMPF), was reviewed. The CMPF indicated, "IST Case Manager (CM) was hired as case manager for the IST Unit. The Job Description/Performance Appraisal and Competency Evaluation Form (JDPACEF), dated 6/7/24, was reviewed. The JDPACEF indicated, CM was evaluated based on the job description, performance, and competency of a program coordinator. ICNO stated she was not aware the IST CM was promoted to a PC.

During an interview on 9/18/24 at 3:20 p.m. with Human Resources Coordinator (HRC), HRC stated Human Resources did not have a record of the IST unit CM being promoted to a PC.

During an interview on 9/19/24 at 11:15 a.m. with PC, in the presence of the Chief Executive Officer (CEO), PC stated her official title was Program Coordinator. PC stated, "I am a Program Coordinator. I help the Director of Competency Restoration Program [DCRP] in the IST Unit." PC stated," I was the case manager but there was not much case management duties in IST, not so much with finding placements." PC stated she held a Degree in Psychology from the University of Phoenix in 2017, one of the qualifications for the position of Program Coordinator." At 12:15 p.m. PC presented herself with DCRP and stated, "I am sorry I did not finish school."

During a concurrent interview and record review on 9/19/24 at 12 p.m. with HRC and ICNO, PC's educational background check, dated 5/24/17, was reviewed. The educational background check from the University of Phoenix indicated, "No degree. Only attendance confirmed." The JDPACEF, dated 6/7/24, was reviewed. JDPACEF indicated," Job requirement- Minimum Education: Bachelor's degree in psychology, Healthcare Administration, Business or a related field and/or a combination of education and experience determined acceptable by regulatory compliance requirements and Hospital Administration." ICNO stated the IST Competency Training record indicated PC did not have the IST competency training. HRC and ICNO stated PC did not meet the requirements of the position of a Program Coordinator.

During a review of the facility's policy and procedure (P&P) titled, "Job Evaluation Policy," the P&P indicated, "3. All existing jobs that require reevaluation due to changes in task and responsibility will be evaluated using the current job description and the completed Job Evaluation Request Form. 4. All new positions must be evaluated and have a written job description before the position is posted or filled."

2. During a concurrent interview and review of employee personnel files on 9/18/24 at 2:25 p.m. with ICNO, the employee personnel files for QRRN, PC, MHW 1, MHW 2, RN 1, RN 2, RN 3, RN 4, and RN 5 were reviewed. The personnel files for the 9 employees indicated, no emergency preparedness training. ICNO confirmed the above employees did not have emergency preparedness training in their orientation .

3. During a concurrent interview and review of employee personnel files on 9/18/24 at 2:35 p.m. with ICNO, the employee personnel files for PC, MHW 1, and MHW 2, were reviewed. The personnel files for PC, MHW 1 and MHW 2 indicated, no infection control training. ICNO confirmed MHW 1 and MHW 2 did not have infection control training in their orientation.

During a review of the facility's P&P titled, "Inservice Education and Training," dated 5/2/22, the P&P indicated, "1 ...All new employees are required to attend orientation. Included in new employee orientation are safety training, infection control procedures, corporate compliance, and communication regarding hazardous materials. All employees with patient care responsibilities are required to attend additional departmental orientation."

During a review of the facility's P&P titled, "Orientation," dated 5/2/22, the P&P indicated, "Departments conduct individual orientation and in-service programs to further acquaint new employees with the individual work areas. These programs are the responsibility of department directors."