Adventist Health Delano

“PATIENT RIGHTS: GRIEVANCE REVIEW TIME FRAMES CFR(s): 482.13(a)(2)(ii) At a minimum: The grievance process must specify time frames for review of the grievance and the provision of a response. This Standard is not met as evidenced by: 39356 Based on interview and record review, the hospital failed to implement its policy and procedure (P&P) titled, “Patient - Related Complaint and Grievance Management” for three of four sampled patients (Patient 19, Patient 20, Patient 21). This had the potential to result in unresolved grievances and/or patients now knowing the outcome of their grievances. Findings: During an interview on 3/5/25 at 9:20 a.m. with Risk and Regulatory Analyst (RRA), RRA stated she was responsible for coordinating the grievance process. RRA stated she recognized there were deficiencies in this process. RRA stated once a grievance was identified, the manager of the department should reach out to the patient involved in the grievance and document the investigation and outcome. RRA stated ideally a closure letter of the outcome would be sent to the patient within seven days. During a concurrent interview and record review on 3/5/25 at 9:25 a.m. with RRA, the hospital’s “Complaint/Grievance Log (CGL)” undated was reviewed. The “CGL” indicated, Patient 19 reported a grievance on 1/2/25. RRA stated the manager of the Emergency Department was assigned to call the patient, but this was not done. RRA stated this resulted in a delay in resolving the patient’s grievance. RRA stated, the patient’s complaint was not resolved in the required 7 days due to the delay of the patient contact which resulted in the final closure letter being sent to the patient on 2/27/25 (54 days later). During a concurrent interview and record review on 3/5/25 at 9:42 a.m. with RRA, the hospitals “CGL” undated was reviewed. The “CGL” indicated, Patient 20 reported a grievance on 1/16/25. RRA stated, there was no final closure letter sent to the patient which should have been done (49 days had passed at the time of the interview). During a concurrent interview and record review on 3/5/25 at 9:47 a.m. with RRA, the hospitals “CGL”, undated was reviewed. The “CGL” indicated, Patient 21 reported a grievance on 2/3/25. RRA stated, there was no final closure letter sent to the patient which should have been done (30 days had passed at the time of the interview). During a review of the hospitals P&P, titled “Patient - Related Complaint and Grievance Management” dated 7/27/22, the P&P indicated, “[Hospital] is committed to providing patients and the patient’s legal representative a complaint and grievance mechanism within the facility designed to promptly resolve patient complaints and grievances regarding the care and service they have received. It is the goal that these complaints and grievances are thoroughly addressed in a timely manner and handled it a way that supports the patient’s right to receive respectful and supportive care. . . C. Grievance Resolution Time Frames 1. Grievances are to be resolved within seven (7) days whenever possible. If the grievance cannot be resolved within the seven (7) days due to its complexity and the need for extensive follow up involving multiple staff members, the facility representative or appropriate department staff will maintain contact with the grievant, in writing if possible, and provide timely updates until a resolution/response can be achieved. Document all contacts with the grievant. The Grievance Committee shall issue a final determination regarding resolution at the conclusion of the investigation. A written notice of the facility’s determination regarding the grievance shall be communicated to the patient or patient’s legal representative in a language and manner that the patient or patient’s legal representative understands.””

“PATIENT RIGHTS: INFORMED CONSENT CFR(s): 482.13(b)(2) 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. This Standard is not met as evidenced by: 40516 Based on interview and record review, the hospital failed to ensure risks, benefits, and alternatives (RBAs) for elective procedures were documented as given prior to the procedure for eight of 11 sampled patients (Patient 1, Patient 3, Patient 4, Patient 5, Patient 6, Patient 7, Patient 8, and Patient 9). This failure had the potential for patients not knowing the procedure’s risks, benefits, and alternatives, preventing the patients from making an informed decision. Findings: During a review of Patient 1’s medical record, the History and Physical (H&P) dated 1/7/25, the H&P indicated Patient 1 was 39 weeks and four days pregnant (40 weeks is full term) and had begun leaking amniotic fluid (water breaking- Sac of liquid that surrounds and protects the developing fetus during pregnancy. Once the sac ruptures the risk of infection to the mother and fetus increases) on 1/6/25 at 10 p.m. The H&P indicated the plan was for induction (start) of labor (IOL) using Oxytocin (medication given through the vein to cause labor contractions). During an interview on 3/4/25 at 8:10 a.m. with RN Regulatory Specialist (RNRS), RNRS stated after reviewing Patient 1’s medical record, she was unable to find a physician order to consent for IOL, a signed consent for IOL, or documented RBAs for IOL. During a review of Patient 1’s nursing “Annotations” dated 1/7/25 at 11:24 a.m., the “Annotations” indicated IOL with Oxytocin was started. During an interview on 3/4/25 at 8:39 a.m. with Registered Nurse (RN) 1, RN 1 stated she had taken care of Patient 1 the prior night shift (1/7/25 from 7 p.m. to 1/8/25 at 7:30 a.m.) and when she returned to work the night shift on 1/8/25 she was surprised that Patient 1 still had not delivered her baby. RN 1 stated she had a discussion with Charge Nurse (CN) about Patient 1 still being pregnant and that her amniotic fluid had been leaking for nearly 48 hours. RN 1 stated she did not document the discussion she had with CN regarding Patient 1 not delivering the baby. During an interview on 3/4/25 at 1:34 p.m. with CN, CN stated that RN 1 discussed her concerns about Patient 1’s slow labor progress. CN stated Physician 1 was at Patient 1’s bedside around 8 p.m. CN stated Physician 1’s decision was to allow Patient 1 to continue with IOL. CN stated she did not document the discussions she had with RN 1 or Physician 1. During a review of Patient 1’s nursing “Annotations” dated 1/8/25, at 8:01 p.m. the “Annotations” indicated, “OB [Obstetric- related to pregnancy and childbirth] provider [physician] at bedside.” During an interview on 3/5/25 at 8:56 a.m. with Physician 1, Physician 1 stated she discussed with Patient 1 the risks involved with continuing to allow Patient 1 to continue with her induction of labor. Physician 1 stated she did not document the discussion. According to an article published by the National Institutes of Health (NIH), “Amniotic membranes are protective to the fetus, with anti-inflammatory [reduces redness and swelling], anti-bacterial [prevents the growth or spread of bacteria], and anti-viral [prevents the growth or spread of viruses] properties. Prolonged rupture of membranes (PROM) is considered when the duration is more than 18 h [hours] prior to delivery.” During a concurrent interview and record review on 3/5/25 at 9:38 a.m. with Interim Manager of Labor & Delivery (IMLD), Patient 3’s medical record was reviewed. The H&P, dated 12/31/24, at 7:30 p.m. indicated, “patient [sic] scheduled for induction of labor.” IMLD stated Patient 3 had an IOL on 12/31/24 and signed a consent for IOL on 12/31/24 at 8 p.m. IMLD stated she was unable to find documented RBAs for IOL. During a concurrent interview and record review on 3/5/25 at 9:53 a.m. with IMLD, Patient 4’s medical record was reviewed. The H&P dated 1/3/26 at 5:59 a.m. indicated Patient 4 came to the hospital for “leaking [amniotic] fluid” and labor. IMLD stated Patient 4 had an augmentation of labor (AOL- using Oxytocin to make labor contractions stronger and more regular) on 1/3/25 and signed a consent for AOL on 1/3/25 at 7:25 a.m. IMLD stated she was unable to find documented RBAs for AOL. During a concurrent interview and record review on 3/5/25 at 10:32 a.m. with IMLD, Patient 5’s medical record was reviewed. The H&P dated 1/6/25 at 9:31 p.m. indicated Patient 5 was “sent from [physician’s] office for advanced dilatation of 5 cm [centimeters- cervix is measured from closed to 10 cm when the baby is ready to be delivered].” IMLD stated Patient 5 had an AOL on 1/6/25. IMLD stated she was unable to find a signed a consent for AOL or documented RBAs for AOL. During a concurrent interview and record review on 3/5/25 at 10:39 a.m. with IMLD, Patient 6’s medical record was reviewed. The H&P dated 1/7/25 at 12:22 a.m. indicated Patient 6 arrived at the hospital for a scheduled IOL. IMLD stated Patient 6 had an IOL on 1/6/25 and signed a consent for IOL on 1/6/25 at 10:10 a.m. IMLD stated she was unable to find documented RBAs for IOL. During a concurrent interview and record review on 3/5/25 at 10:52 a.m. with IMLD, Patient 7’s medical record was reviewed. The H&P dated 1/10/25 at 6:52 a.m. indicated Patient 7 was scheduled for IOL for “cholestasis of pregnancy [Condition that slows or stops the normal flow of bile in the gallbladder and can cause severe itching. Fetuses are at risk as the pregnancy advances, so patients are typically delivered at 37 weeks of pregnancy].” IMLD stated Patient 7 had an IOL on 1/10/25 and signed a consent for IOL on 1/10/25 at 10:30 a.m. IMLD stated she was unable to find documented RBAs for IOL. During a concurrent interview and record review on 3/5/25 at 11:01 a.m. with IMLD, Patient 8’s medical record was reviewed. The H&P dated 1/20/25 at 8:39 p.m. indicated Patient 8 went to the hospital for an “induction of labor.” IMLD stated Patient 8 had an IOL on 1/20/25 and signed a consent for IOL on 1/20/25 at 10:14 a.m. IMLD stated she was unable to find documented RBAs for IOL. During a concurrent interview and record review on 3/5/25 at 11:06 a.m. with IMLD, Patient 9’s medical record was reviewed. The H&P dated 1/26/25 at 11:23 p.m. indicated Patient 9 presented to the hospital with leaking amniotic fluid. IMLD stated Patient 9 had an AOL on 1/26/25 and signed consent for AOL on 1/26/25 at 5:37 p.m. IMLD stated she was unable to find documented RBAs for IOL. During a review of the hospital’s policy and procedure (P&P) titled, “Oxytocin for Induction or Augmentation of Labor” dated 2/21/23, the P&P indicated, “C. Before Oxytocin Administration: 1. Verify that the physician has discussed the indications and the potential risks and benefits of induction or augmentation of labor with the patient and that maternal consent is documented.” During a review of the hospital’s P&P titled, “Consent and Informed Consent” dated 5/4/22, the P&P indicated, “3. The topics that must be addressed in the informed consent discussion are: a. The nature of the operation or procedure, including other care, treatment, services or medication. B. Potential benefits, risks of the operation or procedure, including potential problems that might occur during recuperation. C. The likelihood of achieving the patient’s goals. D. Reasonable alternatives and the relevant risks, benefits and side effects to such alternatives, including the possible results of not receiving the proposed care, treatment and services ... F. Documentation: 1. A document (H&P or progress note) shall be in the patient’s permanent medical record prior to the procedure/treatment identifying that Procedures, Alternatives, Risks and Questions- (PARQ) have been discussed with the patient or the patient’s legal representative ... 4. The nursing staff shall be responsible for verifying that the documentation has been included in the chart PRIOR to surgery/procedure and checking this off the surgical checklist. If these conditions are not met, the proceduralist performing the procedure must be contacted to obtain the required documentation. Non-emergency procedures will be delayed or cancelled [sic] until the informed consent process has been completed and fully documented.””

“STAFFING AND DELIVERY OF CARE CFR(s): 482.23(b) The nursing service must have adequate numbers of licensed registered nurses, licensed practical (vocational) nurses, and other personnel to provide nursing care to all patients as needed. There must be supervisory and staff personnel for each department or nursing unit to ensure, when needed, the immediate availability of a registered nurse for care of any patient. This Standard is not met as evidenced by: 40516 Based on interview and record review, the hospital failed to: 1. Follow its policy and procedure titled, “Oxytocin [medication given through the vein to cause labor contractions] for Induction [to start] or Augmentation [make labor contractions stronger and more regular] of Labor” for eight of 11 sampled patients (Patient 1, Patient 3, Patient 4, Patient 5, Patient 6, Patient 7, Patient 8, and Patient 9). This failure had the potential for adverse outcomes for the mother and fetus [infant still in the womb]. 2. Follow its policy and procedure titled, “NURSING ASSESSMENT AND REASSESSMENT FOR PATIENTS” for one of 11 sampled patients (Patient 1). This failure resulted in an inaccurate medical record and had the potential to negatively affect patient outcome. Findings: 1. During an interview on 3/3/25 at 11:48 a.m. with Director of OB (Obstetrics- childbirth and the care of women giving birth) (DOB), DOB stated the obstetrics department follows standards and guidelines (National organization whose goal is to advance the nursing profession related to obstetric and newborn nursing). During a concurrent interview and record review on 3/5/25 at 9:38 a.m. with Interim Manager of Labor & Delivery (IMLD), Patient 3’s medical record was reviewed. The “History and Physical” (H&P) dated 12/31/24, at 7:30 p.m. indicated, “patient [sic] scheduled for induction of labor.” IMLD stated Patient 3 had an induction of labor (IOL) using Oxytocin. IMLD stated nursing did complete maternal/fetal assessments (uterine activity, fetal heart rate, and any nursing interventions) every 15 minutes while Patient 3 was receiving Oxytocin. IMLD stated nursing did not assess Patient 3’s pain every hour. During a concurrent interview and record review on 3/5/25 at 9:53 a.m. with IMLD, Patient 4’s medical record was reviewed. The H&P dated 1/3/26 at 5:59 a.m. indicated Patient 4 came to the hospital for “leaking [amniotic] fluid” and labor. IMLD stated Patient 4 had an augmentation of labor (AOL) on 1/3/25. IMLD stated nursing did not complete maternal/fetal assessments every 15 minutes while Patient 4 was receiving Oxytocin. IMLD stated nursing did assess Patient 4’s pain every hour. During a concurrent interview and record review on 3/5/25 at 10:32 a.m. with IMLD, Patient 5’s medical record was reviewed. The H&P dated 1/6/25 at 9:31 p.m. indicated Patient 5 was “sent from [physician’s] office for advanced dilatation of 5 cm [centimeters - cervix is measured from closed to 10 cm when the baby is ready to be delivered].” IMLD stated Patient 5 had an AOL on 1/6/25. IMLD stated nursing did not complete maternal/fetal assessments every 15 minutes while Patient 5 was receiving Oxytocin. IMLD stated nursing did not assess Patient 5’s pain every hour. During a concurrent interview and record review on 3/5/25 at 10:39 a.m. with IMLD, Patient 6’s medical record was reviewed. The H&P dated 1/7/25 at 12:22 a.m. indicated Patient 6 arrived at the hospital for a scheduled IOL. IMLD stated Patient 6 had an IOL on 1/6/25. IMLD stated Patient 6 had an AOL on 1/6/25. IMLD stated nursing did not complete maternal/fetal assessments every 15 minutes while Patient 6 was receiving Oxytocin. IMLD stated nursing did not assess Patient 6’s pain every hour. During a concurrent interview and record review on 3/5/25 at 10:52 a.m. with IMLD, Patient 7’s medical record was reviewed. The H&P dated 1/10/25 at 6:52 a.m. indicated Patient 7 was scheduled for IOL for “cholestasis of pregnancy [Condition that slows or stops the normal flow of bile in the gallbladder and can cause severe itching. Fetuses are at risk as the pregnancy advances, so patients are typically delivered at 37 weeks of pregnancy].” IMLD stated Patient 7 had an IOL on 1/10/25. IMLD stated nursing did not complete maternal/fetal assessments every 15 minutes while Patient 7 was receiving Oxytocin. IMLD stated nursing did not assess Patient 7’s pain every hour. During a concurrent interview and record review on 3/5/25 at 11:01 a.m. with IMLD, Patient 8’s medical record was reviewed. The H&P dated 1/20/25 at 8:39 p.m. indicated Patient 8 went to the hospital for an “induction of labor.” IMLD stated Patient 8 had an IOL on 1/20/25. IMLD stated nursing did not complete maternal/fetal assessments every 15 minutes while Patient 8 was receiving Oxytocin. IMLD stated nursing did not assess Patient 8’s pain every hour. During a concurrent interview and record review on 3/5/25 at 11:06 a.m. with IMLD, Patient 9’s medical record was reviewed. The H&P dated 1/26/25 at 11:23 p.m. indicated Patient 9 presented to the hospital with leaking amniotic fluid. IMLD stated Patient 9 had an AOL on 1/26/25. IMLD stated nursing did not complete maternal/fetal assessments every 15 minutes while Patient 9 was receiving Oxytocin. IMLD stated nursing did not assess Patient 9’s pain every hour. During a review of the hospital’s P&P titled, “Oxytocin for Induction or Augmentation of Labor” dated 2/21/23, the P&P indicated, “E. PERFORM MATERNAL/FETAL ASSESSMENT: 1. Perform a maternal fetal assessment every 15 minutes during the first stage of labor [from the onset of regular uterine contractions to when the cervix is completely dilated at 10 centimeters] ... 2. Assess maternal pain every one (1) hour and before and after all pain interventions.” A review of AWHONN’s “Fetal Heart Monitoring Principles and Practices Sixth Edition” indicated documentation of fetal heart monitoring assessment with use of Oxytocin is every 15 minutes. 2. During a review of Patient 1’s medical record, the H&P dated 1/7/25, the H&P indicated Patient 1 was 39 weeks and four days pregnant (40 weeks is full term) and had begun leaking amniotic fluid (water breaking- Sac of liquid that surrounds and protects the developing fetus during pregnancy. Once the sac ruptures the risk of infection to the mother and fetus increases) on 1/6/25 at 10 p.m. The H&P indicated the plan was for induction (start) of labor (IOL) using Oxytocin (medication given through the vein to cause labor contractions). During a review of Patient 1’s nursing “Annotations” dated 1/7/25 at 11:24 a.m. the “Annotations” indicated IOL with Oxytocin was started. During an interview on 3/4/25 at 8:39 a.m. with Registered Nurse (RN) 1, RN 1 stated she took care of Patient 1 the prior night shift (1/7/25 from 7 p.m. to 1/8/25 at 7:30 a.m.) and when she returned to work the night shift on 1/8/25 she was surprised that Patient 1 still had not delivered her baby. RN 1 stated she had a discussion with Charge Nurse (CN) about Patient 1 still being pregnant and that her amniotic fluid had been leaking for nearly 48 hours. RN 1 stated she did not document the discussion she had with CN regarding Patient 1’s baby not being delivered. During an interview on 3/4/25 at 1:34 p.m. with CN, CN stated RN 1 discussed her concerns about Patient 1 making slow progress in labor. CN stated Physician 1 was at Patient 1’s bedside around 8 p.m. CN stated Physician 1’s decision was to allow Patient 1 to continue with IOL. CN stated she did not document the discussion she had with RN 1 or the discussion she had with Physician 1. During a review of Patient 1’s nursing “Annotations” dated 1/8/25, at 8:01 p.m. the “Annotations” indicated, “OB [Obstetric- related to pregnancy and childbirth] provider at bedside.” During an interview on 3/5/25 at 8:56 a.m. with Physician 1, Physician 1 stated she discussed the risks involved with continuing to allow Patient 1 to continue with her induction of labor, but she did not document the discussion. According to an article published by the National Institutes of Health (NIH), “Amniotic membranes are protective to the fetus, with anti-inflammatory [reduces redness and swelling], anti-bacterial [prevents the growth or spread of bacteria], and anti-viral [prevents the growth or spread of viruses] properties. Prolonged rupture of membranes (PROM) is considered when the duration is more than 18 h [hours] prior to delivery.” During a review of the hospital’s P&P titled, “NURSING ASSESSMENT AND REASSESSMENT FOR PATIENTS” dated 9/28/23, the P&P indicated, “I. DOCUMENTATION 1. Documentation should be timely, current and chronological - “chart as you go’ is the preferred method ... Documentation is patient-centered and focused, collaborative, appropriate to the setting in which the care is provided and based on: a. A collaborative comprehensive plan of care that is individualized b. Professional intervention, observation and assessment c. The patient’s current status and their preferences d. The patient’s progress and response to treatment and care e. Collaborative plan-of-care discussions, consultations, and rationales for plan-of-care changes.””

“PATIENT RIGHTS: INFORMED DECISION CFR(s): 482.13(b)(3) The patient has the right to formulate advance directives and to have hospital staff and practitioners who provide care in the hospital comply with these directives, in accordance with §489.100 of this part (Definition), §489.102 of this part (Requirements for providers), and §489.104 of this part (Effective dates). This Standard is not met as evidenced by: 40516 Based on observation, interview, and record review, the hospital failed to follow its policy and procedure (P&P) titled, “Advanced Healthcare Directive, Surrogate Decision Maker” (AD- legal document which outlines an individual’s preferences for medical care if they are unable to communicate them) for three of four sampled patients (Patient 1, Patient 2, and Patient 3). This failure resulted in Patient 1’s, Patient 2’s, and Patient 3’s Patient Rights not being honored and had the potential for their medical choices to not be honored. Findings: During a concurrent observation and interview on 11/25/24 at 10:12 a.m. with Patient Access Representative (PAR) 1, in Outpatient Registration, PAR 1 pre-registered Patient 1 for an outpatient procedure. PAR 1 asked Patient 1 if she had an “emergency contact” and if she had a person who could make medical decisions for her. Patient 1 stated she had a verbal agreement with her daughter but there were no legal documents regarding that agreement. PAR 1 did not ask Patient 1 if she wanted any information on how to formulate an AD. After the pre-registration process was completed, PAR 1 stated she did not ask patients who do not have an AD if they would like more information on how to execute an AD. During an interview on 11/25/24 at 10:19 a.m. with Patient Access Supervisor (PAS), PAS stated she did not know patients who do not have an AD were supposed to be asked if they would like information on how to formulate an AD. During a concurrent observation and interview on 11/25/24 at 10:39 a.m. with PAR 2, in Emergency Department (ED) Registration, PAR 2 registered Patient 2 to be seen in the ED. PAR 2 completed the full registration process and did not ask Patient 2 if she had an AD or wanted information on how to formulate one. PAR 2 stated she did not “typically” ask patients about ADs. PAR 2 stated sometimes she asked patients about ADs “if they are older.” During an interview on 11/25/24 at 11:01 a.m. with Patient 3, Patient 3 stated she had been admitted to the hospital the night before. Patient 3 stated during the registration process she was not asked if she had an AD or if she wanted information on how to formulate an AD. 50409 During an interview on 11/25/24 at 12 p.m. with Patient 2, Patient 2 stated when she was registered in the ED, PAR 2 did not ask her if she had an AD and if she wanted information on how to formulate an AD. Patient 2 stated she wanted more information on how to formulate an AD. During a review of the hospital’s “Patient Rights” (PR) dated April 2024, the PRs indicated, “You have the right to. . . 10. Formulate advance directives. This includes designating a decision maker if you become incapable of understanding a proposed treatment or become unable to communicate your wishes regarding care. Hospital staff and practitioners who provide care in the hospital shall comply with these directives. All patients’ rights apply to the person who has legal responsibility to make decisions regarding medical care on your behalf.” During a review of the hospital’s P&P titled, “Advanced Healthcare Directive, Surrogate Decision Maker,” dated 9/17/24, the P&P indicated, “The intent of this policy is to support a patient’s right to formulate advance directives and to guide [The Hospital] staff and LIP’s [sic] [Licensed Independent Practitioner] who provide care in complying with these directives. This includes the rights of a patient to make medical care decisions, the right to request or refuse treatment, the right to formulate an advance directive and the right to designate a surrogate [person acting on behalf of someone else or as a substitute] decision maker.””

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(10) The condition of the patient who is restrained or secluded must be monitored by a physician, other licensed practitioner or trained staff that have completed the training criteria specified in paragraph (f) of this section at an interval determined by hospital policy. This Standard is not met as evidenced by: 40516 Based on interview and record review, the hospital failed to follow its policy and procedure (P&P) titled, “Restraint Management (Mechanical, Chemical, Seclusion)” for every 15-minute or every two-hour restraint use assessments for four of 18 sampled patients (Patient 6, Patient 9, Patient 4, and Patient 11). This failure had the potential for injuries and adverse health effects caused by use of restraints. Findings: During a concurrent interview and record review on 11/26/24 at 10:10 a.m. with Quality Business Intelligence Analyst (QBIA) and Risk and Regulatory Analyst (RRA) 1, Patient 6’s “Restraint Apply: Non-Violent/Non-Self-Destructive” (RA) flowsheet dated 5/30/24 at 7:21 p.m. was reviewed. The RA indicated Patient 6 was placed in soft restraints on his right and left wrists because he “Engages in potential harmful behaviors.” The “Clinical Data Flowsheet” (CDF) dated 5/30/24 and 5/31/24 was reviewed. The CDF indicated on 5/31/24 there was no every two-hour restraint use assessment at 12 a.m. QBIA and RRA 1 stated the assessment was not completed. During a concurrent interview and record review on 11/26/24 at 11:50 a.m. with QBIA and RRA 1, Patient 9’s RA flowsheet dated 5/5/24 at 3 p.m. was reviewed. QBIA stated Patient 9 was placed in soft restraints on his upper and lower extremities. The RA indicated Patient 9 was placed in restraints because he was a “Danger to self.” The CDF dated 5/5/24 was reviewed. The CDF indicated on 5/5/24 every 15-minute restraint use assessments were not done at 5:15 p.m. or 5:30 p.m. QBIA and RRA 1 stated the assessments were not completed and or documented. 50409 During a concurrent interview and record review on 11/26/24 at 3:05 p.m. with RRA 2, Patient 4’s “Order,” dated 8/31/24 was reviewed. The “Order” indicated, “Restraints Apply: Non-Violent/Non Self-Destructive.” RRA 2 stated Patient 4 had soft restraints on her right and left wrists because she was interfering with devices, tubes, and dressings. During a review of Patient 4’s “Order Plans” (OP), dated 8/31/24, the OP indicated, “Assess restraint use q [every] 2 hours.” During a concurrent interview and record review on 11/26/24 at 3:12 p.m. with RRA 2, Patient 4’s “Restraint Group (RG - Restraint Flowsheet),” dated 11/26/24 was reviewed. The RG indicated on 9/1/24 there was no documentation of restraint use assessments at 12 p.m., 2 p.m., 4 p.m., or 6 p.m. RRA 2 stated the assessments were not done. During a concurrent interview and record review on 11/26/24 at 3:39 p.m. with RRA 2, Patient 11’s “Order,” dated 9/26/24 was reviewed. The “Order” indicated, “Restraints Apply: Non-Violent/Non Self-Destructive.” RRA 2 stated Patient 4 had soft restraints on her right and left wrists because she was interfering with devices, tubes, and dressings. During a review of Patient 11’s OP dated 9/28/24, the OP indicated, “Assess restraint use q 2 hours.” During a concurrent interview and record review on 11/26/24 at 3:44 p.m. with RRA 2, Patient 11’s RG, dated 11/26/24 was reviewed. The RG indicated on 9/30/24 there was no restraint use assessment documented at 8 a.m. RRA 2 stated the assessment was not done. During an interview on 11/26/24 at 12:13 p.m. with Registered Nurse (RN) 1, RN 1 stated patients with non-violent restraints were monitored every two hours. During an interview on 11/26/24 at 12:26 p.m. with RN 2, RN 2 stated, “We check the patient [on restraints] every two hours. We try to go there more often to check for circulation.” During an interview on 11/26/24 at 12:38 p.m. with RN 3, RN 3 stated patients who were on non-violent restraints were monitored every two hours and the restraints were released every 15 minutes to check for circulation. During a review of the hospital’s P&P titled, “Restraint Management (Mechanical, Chemical, Seclusion),” dated 8/20/24, the P&P indicated, “Policy Summary/Intent: 5. Ongoing Monitoring/Documentation. a. Documentation of restraint and/or seclusion episode(s) to include, but not limited to: assessments/re-assessments, interventions, care plan/plan of care modifications, response to interventions, criteria met for discontinuation. i. Ongoing assessments/interventions are documented according to the frequency appropriate to the patients’ condition; such as but not limited to vital signs, circulation, range of motion, hydration, elimination needs, injuries due to restraint(s), and skin integrity. . . 2. After the initial intervention, patients shall be seen face-to-face within 1 hour by a qualified LIP, registered nurse or physician assistant who has received education in accordance with requirements to evaluate: a. Patient’s immediate situation b. Reaction to intervention c. Medical and behavioral condition d. Need to continue or terminate the restraint(s) or seclusion i. If responsible LIP changes at transfer, RN should notify accepting LIP of restraint use. 1. These types of restraint orders are used to protect the physical safety of non-violent or non-self-destructive patients. 2. Orders will be renewed every 3 days if continued restraint(s) are needed. 3. Assessment and monitoring will be conducted at minimum, every 2 hours. F. RESTRAINT CONSIDERATIONS - VIOLENT/SELF-DESTRUCTIVE 1. This type of restraint/seclusion order 1s used for the management of violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, staff, or others. 2. After the initial intervention, patients shall be seen face-to-face within 1 hour by a qualified LIP, registered nurse or physician assistant who has received education in accordance with requirements to evaluate: a. Patient’s immediate situation b. Reaction to intervention c. Medical and behavioral condition d. Need to continue or terminate the restraint(s) or seclusion 3. If the face-to-face evaluation is conducted by a trained RN or physician assistant, that RN or physician assistant must consult the LIP responsible for the care of the patient as soon as possible after the completion of the 1-hour face-to face evaluation. 4. Patients with violent/self-destructive behavior will be monitored every 15 minutes to include documentation of patient status and well-being.””

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(12) [the patient must be seen face-to-face within 1 hour after the initiation of the intervention -- ] §482.13(e)(12)(ii)To evaluate - 1. The patient’s immediate situation; 2. The patient’s reaction to the intervention; 3. The patient’s medical and behavioral condition; and 4. The need to continue or terminate the restraint or seclusion. This Standard is not met as evidenced by: 40516 Based on interview and record review, the hospital failed to follow its policy and procedure (P&P) titled, “Restraint Management (Mechanical, Chemical, Seclusion)” for conducting a face to face assessment (done by a trained physician, nurse practitioner, or registered nurse) within one hour of patient being placed in restraints, for four of 18 sampled patients (Patient 7, Patient 8, Patient 10, and Patient 5). This failure had the potential for injuries and adverse health effects caused by use of restraints. Findings: During a concurrent interview and record review on 11/26/24 at 11 a.m. with Quality Business Intelligence Analyst (QBIA) and Risk and Regulatory Analyst (RRA) 1, Patient 7’s “Restraint Apply: Non-Violent/Non-Self-Destructive” (RA) flowsheet, dated 5/24/24 at 7 a.m. was reviewed. QBIA stated Patient 7 was placed in soft restraints on his right and left arms. The RA flowsheet indicated Patient 7 was placed in restraints because she, “Interferes w/ [with] devices [,] tubes [, and] dressings.” The CDF dated 5/24/24 indicated no one-hour face to face evaluation was completed after Patient 7 was placed in restraints. QBIA stated she could not find the one-hour face to face evaluation. During a concurrent interview and record review on 11/26/24 at 11:35 a.m. with QBIA and RRA 1, Patient 8’s RA flowsheet, dated 8/1/24 at 10:03 p.m. was reviewed. QBIA stated Patient 8 was placed in bilateral upper extremities soft restraints. The RA flowsheet indicated Patient 8 was placed in restraints because he, “Interferes w/ devices [,] tubes [, and] dressings.” The CDF dated 8/1/24 indicated no one-hour face to face evaluation was completed after Patient 8 was placed in restraints. QBIA stated she could not find the one-hour face to face evaluation. During a concurrent interview and record review on 11/26/24 at 12:12 p.m. with QBIA and RRA 1, Patient 10’s RA flowsheet, dated 7/31/24 at 5:49 p.m. was reviewed. QBIA stated Patient 10 was placed in soft restraints on both wrists. The RA flowsheet indicated Patient 10 was placed in restraints because he, “Interferes w/ devices [,] tubes [, and] dressings.” The CDF dated 7/31/24 indicated no one-hour face to face evaluation was completed after Patient 10 was placed in restraints. QBIA stated she could not find the one-hour face to face evaluation. 50409 During a concurrent interview and record review on 11/26/24 at 3:16 p.m. with RRA 2, Patient 5’s “Order,” dated 7/22/24 was reviewed. The “Order” indicated, “Restraints Apply: Non-Violent/Non Self-Destructive.” RRA 2 stated Patient 5 had soft restraints on her right and left wrists because she was interfering with devices, tubes, and dressings. During a concurrent interview and record review on 11/26/24 at 3:20 p.m. with RRA 2, Patient 5’s medical record (MR) was reviewed. The MR indicated there was no documentation of face-to-face evaluation within an hour after the application of restraints on 7/22/24. RRA 2 stated the face-to-face evaluation was not done. During a review of the facility’s P&P, titled “Standard Policy: Restraint Management (Mechanical, Chemical, Seclusion),” dated 8/20/24, the P&P indicated, “This organization recognizes that restraint use has the potential to produce serious consequences, such as physical and psychological harm, loss of dignity, violation of a patient’s rights and even death. It is our intent to provide an environment that minimizes circumstances that give rise to use of restraint(s) and seclusion and maximizes safety when restraint or seclusion is used. . . 2. After the initial intervention [placement of restraints], patients shall be seen face-to-face within 1 hour by a qualified LIP [licensed provider], registered nurse or physician assistant who has received education in accordance with requirements to evaluate: a. Patient’s immediate situation b. Reaction to intervention c. Medical and behavioral condition d. Need to continue or terminate the restraint(s) or seclusion.””