Adventist Health Sierra Vista

“PATIENT RIGHTS: NOTICE OF RIGHTS CFR(s): 482.13(a)(1) A hospital must inform each patient, or when appropriate, the patient’s representative (as allowed under State law), of the patient’s rights, in advance of furnishing or discontinuing patient care whenever possible. This Standard is not met as evidenced by: 49405 Based on observation, interview, and record review, the facility failed to ensure conditions of service (COS - [also known as conditions of admission or conditions of registration] legally binding contractual agreements signed by patients or a legal representative upon admission, outlining the terms of care, financial responsibility, and informed consent) were completed per hospital policies and procedures (P & P) when: 1. A written copy of patient rights was not provided to patients or their legal representatives for nine (9) patients (Patient 400, 401, 402, 403, 404, 405, 406, 407, and 408). 2. Patient 404 was not provided with COS and An “Important Message from Medicare” (IM - a standardized form for Medicare beneficiaries required to be provided to patients within two (2) days of admission) on admission and their legal representative was never contacted regarding COS and IM. 3. No evidence of patient rights and NPP was provided to eight (8) patients (Patient 101, 103, 104, 105, 107, 109, 110 and 111) 4. COS were not signed by three (3) patients (Patient 101, 109 and 111) 5. COS was not provided to Patient 201’s legal representative. 6. COS for Patient 202 was signed in English when the patient spoke only Spanish. This failure resulted in patients and/or their legal representatives not being informed of their patient rights prior to services rendered by the facility. Findings: 1. During a concurrent interview and record review on 02/05/26 at 11:20 a.m. with Director of Patient Access (DPA), the facility’s policy and procedure (P&P) titled, “Patient Rights and Responsibility”, dated 09/03/25 was reviewed. The P&P indicated, “POLICY: Compliance. A. In accordance with Title 22 and other California laws, Joint Commission standards and Medicare Conditions of Participation, [Hospital] and the medical staff have adopted the following list of patient rights. A list of these patient rights shall be posted in both Spanish and English in appropriate places within the hospital and are given to patients on admissions so that these rights may be read by patients or the representatives of their choosing.” DPA stated that the facility practice is to only give patient rights if a patient requests them on admission. DPA acknowledged that Patient rights are not given per P&P. 2. During a review of the facility’s policy and procedure titled, “Obtaining the Condition of Service - COS - Process”, dated 07/07/25, indicated, “Procedure Summary/Intent. Purpose: To ensure that consent of treatment is obtained at time of services per State law, which usually is such that the patient’s consent in necessary before any care of treatment can be rendered unless the patient needs immediate care to save his/her life. Consent of the patient is implied by laws in such instances but exists only during immediate emergency. In all other cases, the act on the part of the Hospital cannot be performed without liability unless the patient has first validly consented thereto. [Hospital] will obtain the Condition of Service (COS) consent for all patients is consistent with the Patient Access Standards and which is included as part of our admission packet ... A. 1. The Admitting Representative will follow the registration process on obtaining a signature on the “Conditions of Service”. a. Obtain a signature on the “Condition of Service” from the patient, parent (if a minor under 18), spouse or legal guardian. 2. Monitoring: b. Every attempt should be made to ensure that the COS has been obtained prior to services being rendered;” During a concurrent interview and record review on 02/05/26 at 11:51 a.m. with DPA, Patient 404’s medical record was review. The COS dated 02/05/26 indicated, Patient 404 was medically unable to sign. The admission form (face sheet) for Patient 404 indicated, patient was admitted 01/23/26. DPA stated, that Patient was not able to sign on admission and the second attempt was not made till 02/05/26. DPA confirmed that Patient 404 has been admitted for 13 days and acknowledged that there was not an attempt to contact Patient 404’s surrogate decision maker and provide COS per facility policy. During a concurrent interview and record review on 02/05/26 at 12:37 p.m. with DPA, Patient 404’s medical record was reviewed. The medical record indicated that Patient was not provided IM. DPA stated that the surrogate decision maker was not contacted to provide the IM and acknowledged that it should have been attempted. During a concurrent interview and record review on 02/05/26 at 12:49 p.m. with Patient Access Representative (PAR), Patient 404’s COS was reviewed. The COS did not have a signature and was dated on 02/05/26 stating “Patient medically unable to sign”. PAR states that there was no representative/family at bedside when PAR attempted to complete COS and IM and confirmed that no attempt was made to contact representative/family by any other means. During a review of the facility’s P&P titled, “Consent and Informed Consent”, dated 12/04/24, indicated, “10. Legal representative: For the purposes of this policy, “legal representative” is used to indicate a person acting on behalf of a patient with respect to privacy and medical information issues (i.e., consent/informed consent for treatment) ... Conditions of Registration: 1. Upon admission or as soon thereafter as reasonably possible the patient or a patient’s legal representative (if patient lacks capacity) will be asked to give consent tot the general medical care and the general terms and conditions for receiving care from the health care facility. This will be presented in the Conditions of Registration form. This form not only authorizes general medica and nursing care to be provided, it also establishes financial responsibility. a. If a patient is not able to sign at the time of admission and a legal representative is not available, the Conditions of Registration form should be signed as soon as the patient has capacity, or a legal representative is available ... G. Obtaining and Documenting Consent by Telephone, Facsimile and Email: 1. Obtaining consent from a person who is not physically present: a. It may be necessary to obtain consent from a legal representative who is not physically present at the medical center. In such cases, the information that would be conveyed to the legal representative if he or she was present in the health care facility must be conveyed using alternative means.” 35399 3. A review of patients (Patient 101, 103, 104, 105, 107, 109, 110 and 111) condition of service (COS) was conducted on 2/6/26. The document titled “COS With NPP Policy” indicated in number 9 “I have received a copy of the Notice of Privacy Practices (NPP) ... Followed by an area where the patient would initialed indicating patient has received a copy. However, there were no initials on this area, the area was blank. In number 18 indicated “I have been offered written information regarding patient rights and responsibilities and other information related to my stay. Followed by an area where the patient would have initialed indicating patient had been offered the information. Again, this area had no initials indicating that the information was offered. During a concurrent review of the electronic COS process and interview with the director of patient access (DPA) and chief financial officer (CFO) on 2/6/26 from 9:30 a.m., to 11:15 a.m., the DPA and CFO were asked how they know if the patient was given a copy of the NPP and were offered information on patient rights if the patient did not initialed on number 9 and 18. Requested evidence that the patients (Patient 101, 103, 104, 105, 107, 109, 110 and 111) were provided with a copy of the NPP and were offered information on patient rights. The facility could not provide evidence that the patients were given a copy of the NPP and were offered information on patient rights. The facility P&P titled “Patient Rights and Responsibilities”, dated 8/6/25, indicated that in accordance with title 22 and other California laws, Joint Commission standards and Medicare conditions of participation, [facility’s name] and the medical staff have adopted the following list of patient rights. A list of these patient’s rights shall be posted in both Spanish and English in appropriate places within the hospital and are given to patients on admissions so that these rights may be read by patients or the representative of their choosing. 4. The facility P&P titled “Obtaining the Condition of Service-COS- Process”, dated 7/7/25, indicates “Presentation of the patient for pre-registration, registration or admission to [facility’s name]. 1. The Admitting Representative will follow the registration process by obtaining a signature on the Conditions of Service. a. Obtain a signature on the Condition of Service from the patient, patient (if a minor under 18), Spouse or legal guardian.” During a concurrent review of Patient 101’s medical record and interview with quality registered nurse (QRN) on 2/5/26 at 12:15 p.m., the record indicated patient was a 40-year-old female who was pregnant with estimated delivery date of 2/16/26. Patient presented to labor and delivery (L&D) unit on 2/3/26 with contractions and was admitted to the D&L. Requested the conditions of service documents for review. During an interview with the director of patient access (DPA) on 2/6/25 at 10:37 a.m., the DPA indicated Patient 101’s conditions of service (COS) documents have not been signed by her. The DPA confirmed the patient had not signed her COS three days later, after being admitted to the hospital. Further review of Patient 109 and Patient 111’s COS documents on 2/6/26 at 10:45 a.m., revealed that the patients had not signed their COS. The DPA acknowledged this. 39520 5. During a review of facility’s Policy and Procedure (P&P) titled, “Consent and Informed Consent - California”, dated 12/4/24, the P&P indicated in part... “POLICY: Compliance - Key Elements A. Identifying who may give consent: 1. Capacity to consent: a. A patient may give a valid consent only if they have “capacity” which means they are able to understand the nature and consequences of a decision and to make and communicate the decision ... b. To give consent, the person must have ALL of the following: ... Mental capacity I. Ability to understand the nature and consequences of a decision and to make and communicate a decision, and includes in the case of proposed health care, the ability to understand its significant benefits, risks, and alternatives... D. Conditions of Registration: 1. Upon admission or as soon thereafter as reasonably possible the possible the patient or a patient’s legal representative (if patient lacks capacity) will be asked to give consent to the general medical care and the general terms and conditions for receiving care from the health care facility. This will be presented in the Conditions of Registration form. This form not only authorizes general medical and nursing care to be provided, it also establishes financial responsibility. a. If patient is not able to sign at the time of admission and a legal representative is not available, the Conditions of Registration form should be signed as soon as the patient has capacity, or a legal representative is available. During a review of Patient 201’s Condition of Service (COS-also known as conditions of admission and/or conditions of registration] document that a patient or legal representative consents to medical treatment, provides the notice of privacy, financial agreement and acceptance of written patient rights) dated 05/21/25, at 11:58 p.m., the COS form indicated that Patient 201 gave verbal consent to admission. During a review of Patient 201’s History & Physical/Admission (H&P) notes dated 05/22/25, the H&P stated the chief complaint for admission was AMS (Altered Mental Status - a change in a person’s level of consciousness, awareness, and cognitive function. It can manifest as a range of symptoms, including: Confusion, Disorientation, Lethargy, Agitation, Hallucinations, Difficulty concentrating or making decisions, and Slurred speech). During a review of Patient 201’s Case Management / Social Service (SS) note dated 05/22/25, the SS note indicated in part ... “Met with Patient 201 bedside. Patient 201 was alert and oriented to self and situation only. Patient 201 believes the year is 1984 ... Patient 201 is wondering where he is going and what is going on ...When asked questions, Patient 201 would start to try to answer and would then not respond to the question. It appeared Patient 201 was trying to think about the answer and then would forget the topic of discussion ...” During a review of Patient 201’s Case Management/Social Service (SS) note dated 05/23/25, the SS note indicated in part ... “The hospital needs to act on behalf of Patient 201 and to request the son (FM 2) be the decision maker for Patient 201 ...” During a review of Patient 201’s Physician Progress Note dated 05/25/25, the progress note indicated in part ... “HEALTHCARE SURROGATE: Patient 201’s son (FM 2) ...” During an interview on 2/5/26 at 3:30 p.m. with the Assistant Director of Clinical Risk Management (DRM), DRM was asked about Patient 201’s surrogate decision maker. DRM verbalized Patient 201’s son (FM 2) had been contacted by the care management team, and it was decided he would be the surrogate decision maker (An adult, other than a patient’s agent or conservator, authorized under the Health Care Decisions Law to make a health care decision for the patient). When asked if the facility gave the COS form to Patient 201’s son (FM 2), the surrogate decision maker, DRM acknowledged and confirmed the facility did not have any documentation that the son (FM 2) (surrogate decision maker) was provided with the COS and further acknowledged had not consented to the Conditions of Service. During a review of facility’s Policy and Procedure (P&P) titled, “Patient Rights and Responsibility”, dated 9/3/25, the P&P indicated in part ... “PURPOSE: the purpose of this policy is to establish a mechanism for educating patient about their rights and responsibilities. POLICY: A ... A list of these patient rights ... are given to patients on admissions so that these rights may be read by patients or the representative of their choosing ...” 6. During a concurrent interview and record review on 2/6/26, at 11:20 a.m., with the Perinatal Services Educator (PSE), Patient 202’s medical record was reviewed. Patient 202’s medical record indicated the patient was admitted to the labor and delivery unit on 2/3/26, and language preference was Spanish. Further review of Patient 202’s medical record indicated the Condition of Service (COS) form dated 2/5/26, at 12:39 p.m., was signed by Patient 202. The COS form was written in English and not Spanish. Further review of the COS form had no documentation of a translator/ interpreter, and was left blank. PSE acknowledged the form was in English and had no evidence of a translator. During a concurrent interview and record review on 2/6/26, at 11:55 a.m., with the Interim Director of Patient Access (DPA), Patient 202’s COS form was reviewed. DPA acknowledged Patient 202 spoke Spanish and the form should have been written in Spanish instead of English. DPA verbalized a translator should have been provided for Patient 202. During a review of facility’s Policy and Procedure (P&P) titled, “Consent and Informed Consent - California”, dated 12/4/24, the P&P indicated in part... “D. Conditions of Registration: 1. Upon admission or as soon thereafter as reasonably possible the possible the patient or a patient’s legal representative (if patient lacks capacity) will be asked to give consent to the general medical care and the general terms and conditions for receiving care from the health care facility. This will be presented in the Conditions of Registration form. This form not only authorizes general medical and nursing care to be provided, it also establishes financial responsibility ...F. Documentation ...a. The consent form should include: v. Name and signature of interpreter and an attestation that the consent has been translated, if applicable ...I. Interpreters ...2. Vital documents, including consent forms, presented by the health care facility staff to a patient must be written in a language that the patient can understand, or translated into such a language with an appropriate qualified interpreter ...””

“PATIENT RIGHTS: EXERCISE OF RIGHTS CFR(s): 482.13(b) Patient Rights: Exercise of Rights This Standard is not met as evidenced by: 39520 Based on interview and record review, the facility failed to ensure staff performed pain reassessments after pain medication intervention for Patient 201. This failure violated Patient 201’s right to an appropriate assessment and management of pain. Findings: During a review of facility’s Policy and Procedure (P&P) titled, “Patient Rights and Responsibility”, dated 9/3/25, the P&P indicated in part ... “The purpose of this policy is to establish a mechanism for educating patient about their rights and responsibilities ...B. Patients have the right to: 9. Appropriate assessment and management of your pain, information about pain, pain relief measures and to participate in pain management decisions ...” During a concurrent interview and record review on 2/5/26, at 12:12 p.m. with the Quality Resource Nurse (QRN 2), Patient 201’s medical record was reviewed. Patient 201’s medical record indicated Patient 201 was having pain, a 3/10, at 1:39 p.m., on 5/26/25, and was given Tylenol 650 mg (medication to relieve pain) by mouth. At 2:47 p.m., Patient 201 continued to have pain a 5/10, and was given Motrin 400 mg (medication to relieve pain) by mouth. Further review of the medical record had no documentation of a pain reassessment after the administration of Motrin. QRN 2 acknowledged there was no pain reassessment documented after the administration of Motrin. QRN 2 verbalized there should have been a pain reassessment within one hour of receiving the pain medication. During a concurrent interview and record review on 2/5/26, at 12:17 p.m. with QRN 2, Patient 201’s medical record was further reviewed. Patient 201’s medical record indicated Patient 201 was having pain, a 4/10, at 8:05 p.m., on 5/26/25, and was given Tylenol 650 mg by mouth. Further review of the medical record had no documentation of a pain reassessment after the administration of Tylenol. QRN 2 acknowledged there was no pain reassessment documented after the administration of Tylenol and there should have been. During a concurrent interview and record review on 2/5/26, at 12:28 p.m. with QRN 2, Patient 201’s medical record was further reviewed. Patient 201’s medical record indicated Patient 201 was having pain, a 5/10, at 10:12 a.m., on 6/19/25, and was given Tylenol 1000 mg IV (intravenous-in the vein). Further review of the medical record had no documentation of a pain reassessment after the administration of Tylenol IV. QRN 2 acknowledged there was no pain reassessment documented after the administration of Tylenol and there should have been. During a review of facility’s Policy and Procedure (P&P) titled, “Pain Management”, dated 8/16/24, the P&P indicated in part ... “The intent of this policy is to address the management, assessment, and reassessment of pain ...3. Pain Reassessment ...a. A pain reassessment shall be performed within one hour after pain intervention ...””

“PATIENT RIGHTS:PARTICIPATION IN CARE PLANNING CFR(s): 482.13(b)(1) The patient has the right to participate in the development and implementation of his or her plan of care. This Standard is not met as evidenced by: 39520 Based on interview and record review, the facility failed to ensure nursing staff developed and implemented a care plan for Patient 201 when: A. Having altered mentation upon admission B. Placed on Comfort Care This failure violated Patient 201’s right to participate in the development of a plan of care when having confusion, delirium, and anxiety, during his hospital admission, and having pain with the new diagnosis of cancer. Findings: A. During a review of Patient 201’s History & Physical/Admission (H&P) notes dated 05/22/25, the H&P stated the chief complaint for admission was AMS (Altered Mental Status - a change in a person’s level of consciousness, awareness, and cognitive function. It can manifest as a range of symptoms, including: Confusion, Disorientation, Lethargy, Agitation, Hallucinations, Difficulty concentrating or making decisions, and Slurred speech). During a review of Patient 201’s Physician Progress Note dated 5/24/25, the progress note indicated in part ... “Assessment/Plan ...1. Acute confusional state, acute delirium, acute metabolic encephalopathy ...unclear etiology ...” During a review of Patient 201’s Nursing Neurological Assessment Flowsheet dated 6/18/25, the flowsheet indicated in part ... “Mentation: Confusion, Orientation: disoriented, Level of Consciousness: Alert, Thought Process: Confused ...” During a concurrent interview and record review on 2/5/26, at 1:00 p.m. with the Quality Resource Nurse (QRN 2), Patient 201’s medical record was reviewed. Patient 201’s medical record indicated there was no care plan developed for altered mental status. QRN 2 acknowledged there was no care plan developed and/or implemented for Patient 201’s altered mental status. When asked if a care plan for Patient 201’s altered mentation should have been developed and implemented, QRN 2 did not know. During a review of facility’s Policy and Procedure (P&P) titled, “Documentation Nursing”, dated 7/7/25, the P&P indicated in part ... “To provide a system for accurate and concise documentation of the nursing process: assessment, planning, intervention, and evaluation, and to reflect the patient plan of care ...C. All admitted patients shall have an individualized patient care plan developed based on nursing diagnosis and/or patient cate needs ...D. Documentation in the medical record shall be pertinent, concise, and reflect nursing interventions to meet the patients care needs, the patient’s response to those interventions and patient status ...” B. During a review of Patient 201’s Physician Progress Note dated 6/19/25, the progress note indicated in part ... “Assessment/Plan: ...Diffuse large B-cell lymphoma (a fast growing cancer of the lymphatic system, a vital part of the immune system arising when white blood cells grow uncontrollably) ...Patient 201 developed hypercalcemia while hospitalized, and the hypercalcemia work up led to the discovery of elevated Vitamin D125, raising the suspicion for recurrence of lymphoma, and after performing a CT scan followed by a biopsy, it was discovered that Patient 201 has recurrent lymphoma ...After meeting with Patient 201’s wife and [name of company] Hospice, it was established with the patient family would like to transition Patient 201 to hospice care ...” During a review of Patient 201’s Physician Orders dated 6/22/25, the orders indicated ... “Routine Comfort Measures Only ...” During a concurrent interview and record review on 2/5/26, at 1:05 p.m. with the Quality Resource Nurse (QRN 2), Patient 201’s medical record was reviewed. Patient 201’s medical record indicated there was no care plan developed for Comfort Care. QRN 2 acknowledged there was no care plan developed and/or implemented for Comfort Care for Patient 201. When asked if a care plan for Comfort Care should have been developed and implemented for Patient 201, QRN 2 did not know. During a review of facility’s Policy and Procedure (P&P) titled, “Patient Rights and Responsibility”, dated 9/3/25, the P&P indicated in part ... “The purpose of this policy is to establish a mechanism for educating patient about their rights and responsibilities ...B. Patients have the right to: 4. You and/or your representative have the right to receive information about your health status, diagnosis, prognosis, course of treatment, prospects for recovery, and outcomes of care (including unanticipated outcomes) in terms you can understand. You have the right to effective communication and to participate in the development and implementation of your plan of care ...””

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(1)(i)(B) [A restraint is-] (B) A drug or medication when it is used as a restriction to manage the patient’s behavior or restrict the patient’s freedom of movement and is not a standard treatment or dosage for the patient’s condition. This Standard is not met as evidenced by: 39520 Based on interview and record review, the facility failed to follow policy and procedures and standards of practice when Patient 201 received a medication with no indication for use (reason why the medication should be administered). This failure violated Patient 201’s right to be free from a chemical restraint (when a medication is administered to control, sedate, or restrict a patient’s movement or behavior). Findings: During an interview on 1/29/26, at 1:29 p.m., with Patient 201’s wife (FM 1), FM 1 verbalized Patient 201 (her husband) was given Seroquel (an antipsychotic medication intended for the use and treatment of Schizophrenia [a chronic severe mental disorder characterized by disruptions in thought, perception, emotions, and behavior] and bipolar disorder [a chronic mental health condition characterized by extreme, often debilitating, shifts in mood, energy, and activity levels alternating between manic highs and depressive lows]) for no medical reason. FM 1 verbalized Patient 201 did not have a diagnosis of a psychiatric condition and did not give consent for this dangerous drug. FM 1 verbalized there is a black box warning about giving this drug and dangerous side effects. FM 1 verbalized Patient 201 had never been prescribed this medication before. FM 1 verbalized when she was able to visit Patient 201 in the hospital, he was not acting psychotic. FM 1 verbalized asking the physician (MD 2) why Patient 201 was on Seroquel, FM 1 verbalized MD 2 told her Patient 201 was agitated with the nurses. FM 1 verbalized the only reason Patient 201 was put on the Seroquel was for convenience for the nursing staff. FM 1 stated “It is illegal to put someone on an antipsychotic for no reason.” During a review of Patient 201’s Emergency Department (ED) Physician Note dated 5/21/25, the ED physician note indicated in part ... “History of Present Illness: Patient 201 an 83-year old male past medical history of dementia presenting to the emergency department for evaluation of Adult Protective Services evaluation ...Physical Exam ...General: conversant ...Neuro: Alert and oriented x2, No focal sensory or strength deficits ...Medical Decision Making: Patient 201 is pleasantly confused ...Screening lab work was obtained and is benign patient was medically cleared at 10:00 p.m. for admission to the emergency department ...” During a review of Patient 201’s Physician Medication Orders dated 5/21/25, the medication orders indicated ... “Give Seroquel 12.5 mg one tablet by mouth at bedtime, STAT (immediately) ...Start Date 5/21/25 at 10:29 p.m ....” During an interview on 2/4/26, at 10:31 a.m., with the emergency department (ED) physician (MD 3), was asked about Patient 201 and the reason for ordering Seroquel. MD 3 verbalized he did not recall why Seroquel was ordered for Patient 201. MD 3 verbalized sometimes can be ordered as a sleep aid in lower doses, especially for an elderly gentleman staying in the ED. MD 3 verbalized he did not recall Patient 201 having behaviors, being agitated, or aggressive with staff. MD 3 was asked if there are other medications that can be used for agitation besides Seroquel, MD 3 verbalized there are other medications like Benzodiazepines (medications to treat anxiety, insomnia, seizures) you can give. MD 3 further verbalized if Patient 201 was being aggressive with staff, there would be a separate note documented in the medical record describing the patient’s behavior and the reasoning for the medication. MD 3 further verbalized could not recall Patient 201 being aggressive or agitated and did not see any other documentation in Patient 201’s medical record. During a review of Patient 201’s Physician Progress Note dated 5/24/25, the progress note indicated in part ... “Patient 201 was frail but alert, cooperative and comfortable looking. Short appropriate responses with lingering mild confusion. No acute events reported overnight ...Physical Exam: Neurological: Pleasant and cooperative. Appropriate affect ...” During a review of Patient 201’s Physician Progress Note dated 5/25/25, the progress note indicated in part ... “Medical Decision Making: Patient 201 has medically improved at this point but still has lingering confusion. At this point, etiology of confusion is unclear but could be multifactorial ...Assessment/Plan: 1. Acute confusional state, acute delirium, acute metabolic encephalopathy (non-traumatic, acute, or chronic brain dysfunction caused by illness, organ failure, or chemical imbalances that alter the brain) ...Will avoid exacerbating causes specially medications and sleep rhythm disturbances ...” During an interview on 2/4/26, at 12:16 p.m., with the physician (MD 2), MD 2 was asked about Patient 201 and the reason for continuing Seroquel. MD 2 verbalized Patient 201 was on Seroquel while trying to figure out why he had delirium. MD 2 was asked if Patient 201 was receiving Seroquel to control behaviors, MD 2 verbalized did not remember, and was just trying to keep the patient safe. MD 2 verbalized that using non-pharmacological interventions first is preferred when trying to help with delirium. MD 2 verbalized Seroquel can be used sometimes to control behaviors and for staff convenience, but is not preferred for that use. MD 2 was reviewing Patient 201’s record and verbalized did not see non-pharmacological interventions being tried first for Patient 201’s delirium. During a review of Patient 201’s Nursing Rounding Notes dated: On 5/22/25 the nursing notes indicated in part ... “Patient 201 resting in bed friends at bedside ...medication given to patient, repositioned ...patient fidgeting in bed, pulling at gown and linens ...Patient pleasant and cooperative ...” On 5/23/25 the nursing notes indicated in part ... “Patient 201 sleeping, hugging pillow ...medication given patient removed IV ....patient pleasant and cooperative ...” On 5/24/25 the nursing notes indicated in part ... “Patient 201 sleeping no signs of distress ...medications given sitting in hall in wheelchair ...” On 5/25/25 the nursing notes indicated in part ... “Patient 201 fidgety, watching TV intermittently ...” On 5/26/25 the nursing notes indicated in part ... “Patient 201 resting with eyes closed ...Patient working with physical therapy ...” On 5/27/25 the nursing notes indicated in part ... “Patient 201 resting with eyes closed ...medications given reoriented ...” On 5/28/25 the nursing notes indicated in part ... “Patient 201 restless and fidgety, trying to get out of bed. Denied need for toilet, stated pain medications would “help” ...” On 5/29/25 the nursing notes indicated in part ... “Patient 201 worked with therapies and now in chair at bedside for lunch ...repositioned patient all needs are met ...” On 5/30/25 the nursing notes indicated in part ... “Patient 201 up in chair at nursing station ...patient is sleeping no needs at this time ...” On 5/31/25 the nursing notes indicated in part ... “Patient up in wheelchair eating lunch ...assessed patient all medications for hour of sleep given. Needs are met ...” On 6/1/25 the nursing notes indicated in part ... “Patient 201 eating lunch independently with nursing cueing ...reorientation to hospital attempted, medications, assessment ...” On 6/2/25 the nursing notes indicated in part ... “Patient 201 calm, sitting in wheelchair near nurses’ station ...patient confused, reoriented, patient pleasant and cooperative ...” On 6/3/25 the nursing notes indicated in part ... “Patient 201 sitting in wheelchair, near nurses’ station ...patient repositioned, TV turned on for activity, patient offered water ...medications per Emar, assessment done ...” On 6/4/25 the nursing notes indicated in part ... “Patient 201 working with physical therapy ...patient resting in bed ...” On 6/5/25 the nursing notes indicated in part ... “Patient 201 working with physical therapy ...medications per Emar, assessment done, patient eating pudding ...” On 6/6/25 the nursing notes indicated in part ... “Patient 201 sitting in chair for lunch ...nurse rounding, patient sleeping, and had no needs at this time ...patient laying comfortably watching TV, reoriented patient ...” On 6/7/25 the nursing notes indicated in part ... “Patient 201 repositioned for comfort ...medications administered, and assessment completed. Patient 201 awake and alert watching TV ...” On 6/8/25 the nursing notes indicated in part ... “Patient 201 repositioned ...patient awake all needs met ...” On 6/9/25 the nursing notes indicated in part ... “Patient 201 sleeping, repositioned, no distress/discomfort noted ...” On 6/10/25 the nursing notes indicated in part ... “Patient 201 working with physical therapy at bedside ...patient sleeping, respirations even and unlabored patient’s wife (FM 1) at bedside ...repositioned patient. Awake and alert. All needs met ...” No nursing documentation was found indicating Patient 201 was agitated or aggressive. During a review of facility’s Policy and Procedure (P&P) titled, “Restraint Management (Mechanical, Chemical, Seclusion)”, dated 1/20/21, the P&P indicated in part ... “H. Restraint: 3. Chemical: Drug or Medication used as a restriction to manage the patient’s behavior or restrict the patient’s freedom of movement and is not a standard treatment or dosage for the patient’s condition ...Basic Rights: 1. Patients have the right to: b. Be free from restraint or seclusion in any form, imposed as a means of coercion, discipline, convenience, or retaliation by staff ....C. Restraint Exemptions: 1. The following are not considered restraint or seclusion and are specifically excluded from the policy: g. Medication (including PRN as needed) used as a standard part of a patient’s treatment plan provided the following criteria are met: i. The medication is used within the pharmaceutical parameters approved by the Food and Drug administration (FDA) and the manufacturer for the indications it is manufactured and label to address, including listed dosage parameters ...ii. The use of the medication follows national practice standards established or recognized by the medical community and/or professional medical association or hospital ...I. It is not a chemical restraint if it is the standard treatment/dosage for the patient’s current condition and is expected to enable the patient to more effectively function in their environment than would be possible without the use of the drug or medication ...G. Education-Patient/Family: 1. When a patient is placed in restraints or seclusion and/or administered a medication as a restraint, the following education (as appropriate) is provided to the patient and/or family: a. an explanation as to the clinical justification for restraint ...b. an explanation of the purpose and use of the restraint ...d. an explanation as to the observation and evaluation of the care that will be provided to the patient ...” During a concurrent interview and record review, on 2/5/26, at 11:20 a.m., with a registered nurse (RN 3), Patient 202’s medical record was reviewed. When asked what are some of the things are you do when reviewing a medication order, before administering a medication. RN 3 verbalized you would want to make sure you had the right patient, the right medication, the right dosing, the right time, the right route, and the right indication. RN 3 verbalized if the nurse had any concerns with giving a medication, he/she should call the physician and clarify the order. Patient 201’s physician medication order for Seroquel was reviewed. The physician medication order indicated to give Seroquel 12.5 mg one tablet by mouth at bedtime. RN 3 acknowledged the indication for use was missing and should be there. RN 3 verbalized you would want to know the reason for which the medication Seroquel was being used for and would need to call the physician for clarification. During a review of facility’s Policy and Procedure (P&P) titled, “Medication Administration”, dated 12/13/24, the P&P indicated in part ... “It is the policy of [name of facility] to ensure that licensed nurses follow accepted standards of practice in the administration of medications to patients ...B. Procedure: 1. Medication Administration: a. Review- prior to administration verify the medication for route, dose, and frequency with the medication administration record (eMAR) and as required, the prescriber’s order. If necessary, the prescriber should be contacted for further clarification and clarified in a verbal or written physician order ...i. Before dispensing, removal from floor stock, or removal from an automated storage and dispensing device, a pharmacist reviews all prescription or medication orders ...ii. The review consists of drug appropriateness, therapeutic duplication, real or potential drug allergies or sensitivities, real or potential interactions, other contraindications, variation from hospital criteria for use and other relevant medication-related issues or concerns ...c. Medication Checklist: vii. The medication is being given for the purpose for which it was ordered ...” During a concurrent interview and record review, on 2/5/26, at 11:54 a.m., with the quality registered nurse (QRN), Patient 202’s medical record was reviewed. The physician medication order indicated to give Seroquel 12.5 mg one tablet by mouth at bedtime. QRN acknowledged the indication for use was missing and should be there. Further review of the Seroquel order indicated ... “This drug has a Black Box Warning ... Consult pharmacist, prescriber and/or prescribing information for guidance ...May increase risk of falls ...” QRN was asked if there was any documentation of notifying the physician or pharmacist before giving the Seroquel medication, QRN verbalized there was no other documentation in the medical record about notifying the physician or pharmacist, and/or receiving clarification about the black box warning and indication for use. During a review of Patient 201’s Medication Administration Record (EMAR), Patient 201 received Seroquel 12.5 mg by one tablet mouth on 5/21/25 through 6/9/25. Seroquel was discontinued on 6/10/25. During a review of the medication package insert for “Seroquel” indicated in part ... “Black Box Warning: Increased Mortality in Elderly Patients with Dementia- Related Psychosis: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. SEROQUEL is not approved for elderly patients with dementia-related psychosis ...Indications and Usage: Seroquel is an atypical antipsychotic indicated for the treatment of: Schizophrenia and Bipolar Disorder ...””

“PATIENT VISITATION RIGHTS CFR(s): 482.13(h)(3), (h)(4) [A hospital must have written policies and procedures regarding the visitation rights of patients, including those setting forth any clinically necessary or reasonable restriction or limitation that the hospital may need to place on such rights and the reasons for the clinical restriction or limitation. A hospital must meet the following requirements]: (3) Not restrict, limit, or otherwise deny visitation privileges on the basis of race, color, national origin, religion, sex, gender identity, sexual orientation, or disability. (4) Ensure that all visitors enjoy full and equal visitation privileges consistent with patient preferences. This Standard is not met as evidenced by: 39520 Based on interview and record review, the facility failed to ensure the right to visitation for Patient 201 when the facility did not follow policy and procedure and denied visitation of Patient 201’s wife (FM 1). This failure violated Patient 201’s right to visitation causing emotional distress and potentially affecting overall health conditions. Findings: During a review of facility’s Policy and Procedure (P&P) titled, “Visitation”, dated 05/08/25, the P&P indicated in part ... “POLICY SUMMARY/INTENT: To define the patient’s right to visitation while receiving care, treatment, and service ...DEFINITIONS: ... B. Justified Clinical Restrictions - Means any clinically necessary or reasonable restriction or limitation imposed on a patient’s visitation rights, which restriction or limitation is necessary to provide safe care to patient or other patients. A justified clinical restriction may include, but need not be limited to, one or more of the following: 1. A court order limiting or restraining contact ... 2. Behavior presenting a direct risk or threat to the patient, hospital staff, or others in the immediate environment ... 3. Behavior disruptive of the functioning of the patient care unit ...4. Behavior disruptive of the comfort and care of patients ...POLICY: COMPLIANCE - KEY ELEMENTS: B. [Name of Facility] shall not restrict, limit, or otherwise deny visitation privileges on the basis of race, color, national origin, religion, sex, sexual orientation gender identity or disability. Visitors shall enjoy full and equal visitation privileges consistent with patient preferences ...G. DESIGNATING A SUPPORT PERSON FOR VISITATION: 1. A patient has the right to designate a support person for visitation ... 2. Not only may the support person visit the patient, but he or she may also exercise a patient’s visitation rights on behalf of the patient with respect to other visitors when the patient is unable to do so ...” During an interview on 1/29/26 at 1:29 p.m., with Patient 201’s wife (FM 1), FM 1 verbalized the hospital would not let her see her husband. FM 1 verbalized was denied visitation from 5/22/25 to 6/8/25. FM 1 verbalized having to get a letter from a lawyer giving permission to visit her husband. During a review of Patient Rounding Nursing Notes dated 5/24/25, the nursing note indicated in part ... “Patient 201 wants to call wife (FM 1) ...” During a review of Case Management / Social Services note (SS) dated 06/03/25, the SS note indicated in part ... “Patient 201’s son (FM 2) called and requested that Patient 201’s wife (FM 1) wants to visit the patient but was denied by security ...” During an interview on 2/5/26 at 3:35 p.m. with the Assistant Director of Clinical Risk Management (DRM), DRM verbalized that Patient 201’s wife (FM 1) tried to visit on multiple occasions and was not allowed to visit. DRM verbalized that the facility made the decision to not allow visitation of FM 1 based on Adult Protective Service (APS) guidance, as they were waiting for a court hearing. During an interview on 2/5/26 at 9:40 a.m. with a Social Worker (SW1), SW1 verbalized Patient 201’s wife (FM 1) was denied visitation based on the guidance of Adult Protective Service (APS). SW1 verbalized there was no restraining order filed on admission. SW1 verbalized was not given a court order by APS at anytime during the hospitalization. SW1 verbalized had been communicating with APS and was informed that the court order issued 06/05/25 did not state the Patient 201 could not reside with wife (FM 1) or not be in the same room with wife (FM 1), that those orders were omitted and would be revised to be included at the next court hearing. SW1 verbalized had no problems interacting with Patient 201’s wife (FM 1). During a review of Patient 201’s Physician Progress Note dated 6/18/25, the progress note indicated in part ... “ The physician (MD 1) went to check on Patient 201 later that afternoon, and he (Patient 201) was resting peacefully with his wife (FM 1) at bedside ...MD 1 indicated it is obvious that he (Patient 201) is much more comfortable when he is accompanied by his wife (FM 1) ...When he is surrounded by unfamiliar faces in foreign environments, he is much more prone to delirium and anxiety ...My colleague (MD 2) has noticed this pattern too ...Because of this, MD 1 was requesting the house supervisor make arrangements for Patient 201’s wife (FM 1), other family members and loved ones, be able to stay at the hospital with Patient 201 beyond normal visiting hours ...” During a review of facility’s Policy and Procedure (P&P) titled, “Patient Rights and Responsibility”, dated 9/3/25, the P&P indicated in part ... “The purpose of this policy is to establish a mechanism for educating patient about their rights and responsibilities ... “POLICY: A ... A list of these patient rights ... are given to patients on admissions so that these rights may be read by patients or the representative of their choosing ... “18. Be informed of your right and / or your representative’s right, regarding visitation, including any clinically necessary or reasonable restrictions and /or limitations ...You and /or your representative has the right to consent to receive visitors whom you designate including, but not limited to, a spouse, a domestic partner (including a same-sex domestic partner), another family member, or a friend, and your right to withdraw or deny such a consent at any time ... To be ensured that all visitors enjoy full and equal visitation privileges consistent with patient preferences ...””

“GOVERNING BODY CFR(s): 482.12 There must be an effective governing body that is legally responsible for the conduct of the hospital. If a hospital does not have an organized governing body, the persons legally responsible for the conduct of the hospital must carry out the functions specified in this part that pertain to the governing body ... This Condition is not met as evidenced by: 40678 The Condition of Participation is NOT met as follows: Based on observation, interview, and record review, the hospital’s Governing Body (GB) failed to assume full legal responsibility for implementing and monitoring policies related to the hospital’s quality assessment and performance improvement program, the hospital’s pharmacy operations, and providing oversight of the provision of quality health care in a safe environment, as follows: Findings: A. The facility failed to ensure that care was delivered to patients in a safe manner for 36 sampled patients when: 1. The facility failed to follow their policy and procedures (P&P) for written informed consent when an anesthesia consent was incomplete for one patient, and the anesthesia consent was signed with the incorrect date and time by the anesthesiologist for one patient. (Refer to A-0131) 2. The facility failed to ensure the privacy of health records was maintained for one patient when hospital records belonging to another patient were placed in the patient’s physical medical record. (Refer to A-0142) 3. The facility failed to provide care in a safe setting when medication administration guard rails (safety features built into medication administration systems) were not adhered to resulting in a Tylenol (mild pain medication that is toxic and potentially deadly to the body when given in large amounts) overdose. When a secure unit door from the Mother-Baby Unit into Physical Therapy (PT) room was found unlocked and unsecure and the staff elevator entering the secured Mother-Baby Unit was found unsecured and accessible to visitors. When supplies were not stored in a secure manner in an anesthesia supply cart (a mobile cart that holds medical equipment, supplies, and sharps [any devices with a sharp point or edge that can cut or puncture skin: needles, syringes, scalpel, lancets]) was unlocked in the endoscopy (a medical procedure that uses a flexible tube with a camera to look inside the body) suite, an endoscopy suite supply cabinet was unlocked with sharp supplies inside, and a “max flow flush” 100 lpm (liters per minute) flow meter (a device delivering high flow oxygen used only for specialized oxygen delivery) was stored in the Telemetry (Tele - area of the hospital that has continuous monitoring) unit supply room next to the 15-liter flow meters (device used for routine oxygen delivery). When two single use scissors were stored opened in the medication room in the Tele unit and two suture kits were found expired in the Telemetry supply room. (Refer to A-0144) 4. The facility failed to ensure restraint assessment, documentation and monitoring were not implemented per P&P. Failed to ensure a physician order was received when renewing restraints and for a one-to-one (1:1) Patient Safety Attendant. Failed to ensure 1:1 observer documented per P&P. (Refer to A-0167) When a Crash cart (a mobile cart that holds medical equipment, supplies, and medications, used in life treating situations) located in Computed Tomography (CT) Room was without having its required daily safety check completed.. Water filters for ice/water dispenser and coffee maker in the Labor and Delivery Department, Medical Surgical Units, Intensive Care Unit (ICU), Telemetry unit and Cardiovascular Intensive Care Unit (CVICU) were expired and not dated as per facility policy. When Preventative Maintenance (PM’s) for the breast milk storage refrigerator located in the nursery, the pharmacy medication refrigerator and freezer were completed per the manufacturer’s instructions for use (MIFU’s), one IV pump (medical device that delivers fluids and medications into the patient at a precise rate) had correct preventive maintenance (PM) dates for biomedical engineering sticker and an ultrasound machine (a machine that uses sound waves to reflect off of body structures to create pictures) found without initial inspection prior to use. 5. The facility failed to ensure the emergency department (ED) nursing staff monitored patients every 15 minutes per P&P when in four-point restraints (method of physically immobilizing a person by securing all four of their limbs simultaneously) for violent/self-destructive behavior and obtain the correct restraint order for restraints. (Refer to A-0178) The cumulative effects of these systemic failures resulted in the hospital’s inability to ensure the delivery of quality health care in a safe environment where patient rights were protected. B. The hospital’s Governing Body (GB) failed to ensure the hospital had developed, implemented and maintained an effective, ongoing, hospital-wide, data-driven quality assessment, and performance improvement program, when: 1. The hospital’s GB failed to ensure the intensive care unit (ICU) medication titration performance improvement project (PIP) data collection was measured, analyzed appropriately and the data results reflected the medication titration improvement practice needed. This failure resulted in the data collection results indicating the medication titration PIP meeting its benchmark of 95%. However, the medication titration practice did not correlate with the data results. (Cross Reference A-0273) 2. The hospital’s GB failed to ensure the ICU leader set their performance improvement projects (PIPs) priorities to focus on high-volume, high-risk and problem prone. This failure resulted in the ICU’s PIPs conducted not focusing on the above three priorities. (Cross Reference A-0283) 3. The hospital’s GB failed to ensure the performance improvement projects (PIPs) were conducted with the model and/or methodology which includes the reasons for conducting the project, and the measurable progress achieved on the PIP. This failure resulted in the hospital’s services performing PIPs without a model/methodology that included reasons and progress of the PIP. (Cross Reference A-0297) 4. The hospital’s GB failed to ensure every service including the labor and delivery (L&D) conducted a performance improvement project (PIP) annually. This failure resulted in L&D not conducting a PIP annually. (Cross Reference A-0309) These failures put patients at potential risk for substandard care, adverse events, and negative outcomes. The cumulative effect of these systemic problems resulted in the inability of the hospital to comply with the statutorily mandated Condition of Participation for Quality Assessment and Performance Improvement (QAPI). C. The hospital failed to ensure nursing services were provided in a safe manner, when hospital policies and procedures (P&P) and standards of practice were not followed when: 1. Care plans for pain were not developed for 2 out of 36 sampled Patients (Patient 302, and Patient 400). (Cross Reference A-396). 2. Vital signs were not completed for one of six sample patients (Patient 401), per their the facility’s policy and procedure (P&P) in their Stepdown Unit (an area that require close monitoring and specialized care) / Telemetry Unit (Tele - an area of a hospital who require continuous cardiac monitoring) unit. (Cross Reference A-398). 3. Consent for blood transfusion was not completed per facility’s P&P for one of six sample patients (Patient 403). (Cross Reference A-398). 4. The crash cart (a mobile cart that holds emergency medical equipment, supplies and drugs used in a life-threatening situation) and the Malignant Hyperthermia cart (emergency medications and supplies used for treating malignant hyperthermia-a rare, life-threatening condition) were not checked as per P&P in the Intensive Care Unit (ICU - area of the hospital that provides care to patients with life threatening illness or injury). (Cross Reference A-398). 5. Intravenous (IV) site was not labeled with the start date as per P&P for one of three sample patients (Patient 103) in the ICU. (Cross Reference A-398). 6. Levophed (powerful medication primarily used in emergency and critical care settings to raise and maintain blood pressure in adult patients experiencing severe, acute hypotensive states), Precedex (a medication used as a sedative), and Propofol (a medication used as a sedative) medication drip titration were not performed correctly, and RASS scores (a scoring system used to measure a patients level of alertness) for one of three sample patients (Patient 101). (Cross Reference A-398). 7. Patient medication assessment was not completed as per P&P for one of three sample patients (Patient 103). (Cross Reference A-398). 8. A laryngoscope (a medical tool used to guide a breathing tube through the vocal cords into the throat for mechanical breathing) handle was expired in the Labor and Delivery (L&D). (Cross Reference A-398). 9. Tylenol administration was conducted per P&P by two Registered Nurses (RN) for one of four sampled patients (Patient 301). (Cross Reference A-398). 10. Pain Management P&P was not followed for four of four sample patients (Patient 204, Patient 302, Patient 303 and Patient 400). (Cross Reference A-398). 11. A Morphine order was written without parameters for a maximum dose. (Cross Reference A-405) The cumulative effects of the hospital’s systematic failure to follow policy and procedures, protocols, standards of practice for nursing care and services, and safe medication administration, resulted in the hospital’s inability to ensure the provision of safe patient care, and resulted in the Tylenol overdose for one patient (Patient 301). D. The hospital failed to ensure that safe pharmaceutical services had been provided and meet the needs of each patient as evidenced by: 1. The hospital failed to ensure that all of the Tylenol orders were reviewed and approved, in accordance with the hospital’s policies and procedures. (Refer to A-491) 2. The hospital failed to ensure the pharmacy staff dispensed medications correctly to all ICU patients. Thiamine (to support ICU patients with conditions like septic shock, heart failure, or lactic acidosis) medication which required protection from light. (Refer to A-501) 3. The hospital failed to ensure that patients’ own medications remained secure (as the hospital outlined in reference to the DEA’s Pharmacist Drug Handbook), without the hospital taking possession of these drugs and preventing a possible diversion opportunity, even after a patient had been discharged, and the patient’s own medications were being sent for destruction, by the hospital. (Refer to A-502) 4. The hospital failed to ensure to label all multi-dose vials per the facility’s policy and procedure. (Refer to A-505) 5. The hospital failed to ensure the pharmacist verified the injectable Tylenol (temporarily relieve mild to moderate pain and reduce fever) medication orders to adhere to the Automatic Stop Process. (Refer to A-507). 6. The hospital failed to ensure that it followed it medication error policies and procedures. (Refer to A-508) 7. The hospital failed to ensure that all of the hospital’s current drugs on the hospital’s drug formulary were available for administration and that the hospital had implemented their policies and procedures accordingly. (Refer to A-511) E. The hospital failed to ensure that two of the hospital’s Physician’s followed the hospital’s policies and procedures and the hospital’s Rules and Regulation regarding two Tylenol medication orders. (Refer to A-0353) These failures had the potential to result in significant harm, including liver damage, due to the administration of excessive doses of Tylenol (Acetaminophen) to one patient during their hospital stay, and demonstrated a critical breakdown in medication safety protocols, including the lack of safeguards to prevent a patient from receiving multiple doses of the same medication. The cumulative effects of these systemic failures resulted in the Governing Body not ensuring the provision of safe, effective, and high-quality health care and services, including oversight of safe medication administration practices.”

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 49405 The Condition of Participation is NOT met as follows: Based on observation, interview, and record review, the facility failed to ensure that patient care was delivered in a safe and effective manner to 36 sampled patients when: 1. The facility failed to follow their policy and procedures (P&P) for written informed consent when an anesthesia consent was incomplete for one patient, and the anesthesia consent was signed with the incorrect date and time by the anesthesiologist for one patient. (Refer to A-0131) 2. The facility failed to ensure privacy of health records were maintained for one patient when hospital records of another patient were placed in Patients physical medical record. (Refer to A-0142) 3. The facility failed to provide care in a safe setting when medication administration guard rails were not adhered to resulting in a Tylenol (medication that is toxic and potentially deadly to the body when given in large amounts) overdose. When a Crash cart (a mobile cart that holds medical equipment, supplies, and medications, used in life treating situations) was located in Computed Tomography (CT) Room missing daily check. Water filters for ice/water dispenser and coffee maker in the Labor and Delivery Department, Medical Surgical Units, Intensive Care Unit (ICU), Telemetry unit and Cardiovascular Intensive Care Unit (CVICU) were expired and not dated as per facility policy. When Preventative Maintenance (PM’s) for the breast milk storage refrigerator, in the nursery, the pharmacy medication refrigerator and freezer were competed per the manufacturer’s instructions for use (MIFU’s), one IV pump (medical device that delivers fluids and medications into the patient at a precise rate) had correct preventive maintenance (PM) dates for biomedical engineering sticker and an ultrasound machine (a machine that uses sound waves to reflect off of body structures to create pictures) found without initial inspection prior to use. When a secure unit door from the Mother-Baby Unit into Physical Therapy (PT) room was found unlocked and unsecure and the staff elevator entering the secured Mother-Baby Unit was found unsecured and accessible to visitors. When supplies were not stored in a secure manner in an anesthesia supply cart (a mobile cart that holds medical equipment, supplies, and sharps [any devices with a sharp point or edge that can cut or puncture skin: needles, syringes, scalpel, lancets]) was unlocked in the endoscopy (a medical procedure that uses a flexible tube with a camera to look inside the body) suite, an endoscopy suite supply cabinet was unlocked with sharp supplies inside, and a “max flow flush” 100 lpm (liters per minute) flow meter (a device delivering high flow oxygen used only for specialized oxygen delivery) was stored in the Telemetry (Tele - area of the hospital that has continuous monitoring) unit supply room next to the 15-liter flow meters (device used for routine oxygen delivery). When two single use scissors were stored opened in the medication room in the Tele unit and two suture kits were found expired in the Telemetry supply room. (Refer to A-0144) 4. The facility failed to ensure restraint assessment, documentation and monitoring were not implemented per P&P. Failed to ensure a physician order was received when renewing restraints and for a one-to-one (1:1) Patient Safety Attendant. Failed to ensure 1:1 observer documented per P&P. (Refer to A-0167) 5. The facility failed to ensure the emergency department (ED) nursing staff monitored patients every 15 minutes per P&P when in four-point restraints (method of physically immobilizing a person by securing all four of their limbs simultaneously) for violent / self-destructive behavior and obtain the correct restraint order for restraints. (Refer to A-0178) The cumulative effects of these systemic failures resulted in the hospital’s inability to ensure the provision of quality health care in a safe environment while patient rights were protected.”

“QAPI CFR(s): 482.21 The hospital must develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program. The hospital’s governing body must ensure that the program reflects the complexity of the hospital’s organization and services; involves all hospital departments and services (including those services furnished under contract or arrangement); and focuses on indicators related to improved health outcomes and the prevention and reduction of medical errors. The hospital must maintain and demonstrate evidence of its QAPI program for review by CMS. This Condition is not met as evidenced by: 35399 The Condition of Participation is NOT met as follows: Based on interview and record review, the facility’s Governing Body (GB) failed to ensure that the hospital developed, implemented, and maintained an effective, ongoing, hospital-wide, data-driven Quality Assessment and Performance Improvement (QAPI) program, as required when: 1. The hospital’s GB failed to ensure the intensive care unit (ICU) medication titration performance improvement project (PIP) data collection was measured, analyzed appropriately and the data results reflected the medication titration improvement practice needed. This failure resulted in the data collection results indicating the medication titration PIP meeting its benchmark of 95%. However, the medication titration practice did not correlate with the data results. (Cross Reference A-0273) 2. The hospital’s GB failed to ensure the ICU leader set their performance improvement projects (PIPs) priorities to focus on high-volume, high-risk and problem prone. This failure resulted in the ICU’s PIPs conducted not focusing on the above three priorities. (Cross Reference A-0283) 3. The hospital’s GB failed to ensure the performance improvement projects (PIPs) were conducted with the model and/or methodology which includes the reasons for conducting the project, and the measurable progress achieved on the PIP. This failure resulted in the hospital’s services performing PIPs without a model/methodology that included reasons and progress of the PIP. (Cross Reference A-0297) 4. The hospital’s GB failed to ensure every service including the labor and delivery (L&D) conducted a performance improvement project (PIP) annually. This failure resulted in L&D not conducting a PIP annually. (Cross Reference A-0309) These failures placed patients at risk for substandard care, adverse events, and poor health outcomes. The cumulative effect of these systemic issues resulted in the hospital’s noncompliance with the Condition of Participation for Quality Assessment and Performance Improvement (QAPI).”

“NURSING SERVICES CFR(s): 482.23 The hospital must have an organized nursing service that provides 24-hour nursing services. The nursing services must be furnished or supervised by a registered nurse. This Condition is not met as evidenced by: 39520 The Condition of Participation is not met as follows: Based on observation, interview, and record review, the hospital failed to ensure nursing services were provided in a safe manner, when hospital policies and procedures (P&P) and standards of practice were not followed when: 1. Care plans for pain were not developed for 2 out of 36 sampled Patients (Patient 302, and Patient 400). (Cross Reference A-396). 2. Vital signs were not completed for one of six sample patients (Patient 401), per their the facility’s policy and procedure (P&P) in their Stepdown Unit (an area that require close monitoring and specialized care) / Telemetry Unit (Tele - an area of a hospital who require continuous cardiac monitoring) unit. (Cross Reference A-398). 3. Consent for blood transfusion was not completed per facility’s P&P for one of six sample patients (Patient 403). (Cross Reference A-398). 4. The crash cart (a mobile cart that holds emergency medical equipment, supplies and drugs used in a life-threatening situation) and the Malignant Hyperthermia cart (emergency medications and supplies used for treating malignant hyperthermia-a rare, life-threatening condition) were not checked as per P&P in the Intensive Care Unit (ICU - area of the hospital that provides care to patients with life threatening illness or injury). (Cross Reference A-398). 5. Intravenous (IV) site was not labeled with the start date as per P&P for one of three sample patients (Patient 103) in the ICU. (Cross Reference A-398). 6. Levophed (powerful medication primarily used in emergency and critical care settings to raise and maintain blood pressure in adult patients experiencing severe, acute hypotensive states), Precedex (a medication used as a sedative), and Propofol (a medication used as a sedative) medication drip titration were not performed correctly, and RASS scores (a scoring system used to measure a patients level of alertness) for one of three sample patients (Patient 101). (Cross Reference A-398). 7. Patient medication assessment was not completed as per P&P for one of three sample patients (Patient 103). (Cross Reference A-398). 8. A laryngoscope (a medical tool used to guide a breathing tube through the vocal cords into the throat for mechanical breathing) handle was expired in the Labor and Delivery (L&D). (Cross Reference A-398). 9. Tylenol administration was conducted per P&P by two Registered Nurses (RN) for one of four sampled patients (Patient 301). (Cross Reference A-398). 10. Pain Management P&P was not followed for four of four sample patients (Patient 204, Patient 302, Patient 303 and Patient 400). (Cross Reference A-398). 11. A Morphine order was written without parameters for a maximum dose. (Cross Reference A-405) The cumulative effects of the hospital’s systematic failure to follow policy and procedures, protocols, standards of practice for nursing care and services, and safe medication administration, resulted in the hospital’s inability to ensure the provision of safe patient care, and resulted in the Tylenol overdose for one patient (Patient 301).”

“Condition of Participation: Pharmaceutical Se CFR(s): 482.25 §482.25 Condition of Participation: Pharmaceutical Services. The hospital must have pharmaceutical services that meet the needs of the patients. The institution must have a pharmacy directed by a registered pharmacist or a drug storage area under competent supervision. The medical staff is responsible for developing policies and procedures that minimize drug errors. This function may be delegated to the hospital’s organized pharmaceutical service. This Condition is not met as evidenced by: 13095 The Condition of Participation is NOT met as follows: Based on observation, interview, and record review the hospital failed to ensure that safe pharmaceutical services had been provided to meet the needs of each patient as evidenced by: 1. The hospital failed to ensure that all Tylenol orders were properly reviewed and approved, in accordance with the hospital’s policies and procedures. (Refer to A-491) 2. The hospital failed to ensure the pharmacy staff dispensed medications correctly to all ICU patients. Thiamine (to support ICU patients with conditions like septic shock, heart failure, or lactic acidosis) medication which required protection from light. (Refer to A-501) 3. The hospital failed to ensure that patients’ own medications remained secure (as the hospital outlined in reference to the DEA’s Pharmacist Drug Handbook), without the hospital taking possession of these drugs and preventing a possible diversion opportunity, even after a patient had been discharged, and the patient’s own medications were being sent for destruction, by the hospital. (Refer to A-502) 4. The hospital failed to ensure that all multi-dose vials were labeled per the facility’s policy and procedure. (Refer to A-505) 5. The hospital failed to ensure the pharmacist verified the injectable Tylenol (temporarily relieve mild to moderate pain and reduce fever) medication orders to adhere to the Automatic Stop Process. (Refer to A-507). 6. The hospital failed to ensure that it followed it’s medication error policies and procedures. (Refer to A-508) 7. The hospital failed to ensure that the all of the hospital’s current drugs on the hospital’s drug formulary were available for administration and that the hospital had implemented their policies and procedures accordingly. (Refer to A-511) The cumulative effect of these systemic problems resulted in the facility’s inability to ensure the provision of quality health care, in compliance with the Condition of Pharmaceutical Services.”

“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: 39520 Based on interview and record review, the facility failed to follow their policy and procedures for written informed consent (patient agrees to a treatment or procedure after being told what it is) when: 1.The anesthesia (medicine that stops you from feeling pain during surgery) consent was incomplete for one of 36 sampled patients (Patient 202). 2.The anesthesia consent was signed with the incorrect date and time by the anesthesiologist for one of 36 sampled patients (Patient 304). These facility failures had the potential risk of Patient 202 and Patient 304 not having the right to make an informed decision and potential for not understanding the risks and benefits of the surgical and anesthesia procedures. Findings: 1. During a concurrent interview and record review, on 11/6/25, at 9:12 a.m., with the clinical educator (CE), Patient 202’s medical record was reviewed. The medical record indicated Patient 202 was consented for a Cesarean Section (the surgical delivery of a baby through a cut made in the woman’s abdomen and uterus) and consented for anesthesia services, to perform the Cesarean Section procedure. During a review of the anesthesia consent form, the first page had a line for the name of the Practitioner to write their name and was left blank. The type of anesthesia to be used was also left blank, and the box was not checked. The patient initials box on the top of the first page was also left blank. CE acknowledged the anesthesia consent was incomplete for Patient 202. The CE stated there was no documentation in Patient 202’s medical record indicating that the anesthesiologist had informed the patient about the type of anesthesia to be used for the procedure, and confirmed that such documentation should have been present. During a review of the facility’s policy and procedure titled, “Consent and Informed Consent” dated 5/4/22, indicated in part ... “4. Responsibility: a. The Practitioner who ordered the procedure is responsible for providing the patient or patient legal representative with the information that is necessary to allow an “informed decision” to be made and obtaining informed consent or refusal. The informed consent or refusal must be obtained and documented prior to performance of the procedure ...F. Documentation: 2. Consent to surgery or Special Procedure Form: a. The consent should include: i. The name of the patient ...ii The medical terminology for the procedure (without abbreviation) and the type of anesthesia to be used ...iii. Name of practitioners who will perform important parts of the procedure/treatment service ...” 40678 2. During a review of the facility’s policy and procedure (P&P) titled, “Consent and Informed Consent” dated 5/4/22, indicated... “The Practitioner who ordered the procedure is responsible for providing the patient or patient legal representative with the information that is necessary to allow an “informed decision” to be made and obtaining informed consent or refusal. The informed consent or refusal must be obtained and documented prior to performance of the procedure... The consent should include: The name of the patient... The medical terminology for the procedure (without abbreviation) and the type of anesthesia to be used... Name of practitioners who will perform important parts of the procedure/treatment service... Ensure where signature is applied that it is accompanied with a date and time ...” During a concurrent interview and record review, on 11/4/25, at 10:10 a.m., with the director of surgical services (DSS ), Patient 304’s medical record was reviewed. The medical record indicated Patient 304 was consented to receive monitored anesthesia care for a colonoscopy (procedure to visualize the colon by inserting a scope that has camera). During a review of the anesthesia consent form, the date and time documented for the anesthesia provider certification was documented as on 11/4/25 at 1250, Patient 304’s anesthesia monitoring time started on 11/3/25 at 12:17 p.m. DSS acknowledged and confirmed the date and time were documented incorrectly on the consent and the facility P&P was not followed.”

“PATIENT RIGHTS: PRIVACY AND SAFETY CFR(s): 482.13(c) Patient Rights: Privacy and Safety This Standard is not met as evidenced by: 49405 Based on interview and record review, the facility failed to ensure the privacy of health records was maintained for one of six sampled patients (Patient 401), when hospital records belonging to another patient were found in Patient 401’s chart. This failure had the potential to breach patient confidentiality and lead to harm by causing incorrect treatment, medication administration, or procedures to be performed based on inaccurate information. Findings: During a review of Patient 401’s medical record (MR) paper chart (patient’s medical information) on 11/04/25 at 4:00 p.m., medical records belonging to an unsampled, discharged patient (Patient 406) were found in Patient 401’s chart. Intensive Care Unit Coordinator Clinical Educator (CE2) confirmed the error, stating Patient 406’s records should not have been in Patient 401’s chart and acknowledged that Patient 406’s medical record is now incomplete due to the missing documents. During a review of the facility Policy and Procedure (P&P) titled, “Medical Record Content and Completeness, dated 12/06/24, indicated in part, “POLICY SUMMARY/INTENT: Provide guidelines for the organization and content of the patient’s medical record and to ensure medical documentation is in compliance with Medical Staff Bylaws, Joint Commission, CMS and other regulatory agencies as well as to identify the appropriate contents of the patient medical record, maintenance and purpose ... POLICY: COMPLAINCE - KEY ELEMENTS, Content: A. All clinical entries in the patient medical record shall be accurately dated, timed and authenticated ... COMPLETENESS: A. The medical record shall be considered complete when all required contents are included in the electronic health record (EHR) and properly authenticated.”

“PATIENT RIGHTS: CARE IN SAFE SETTING CFR(s): 482.13(c)(2) The patient has the right to receive care in a safe setting. This Standard is not met as evidenced by: 50132 Based on observation, interview, and record review, the facility failed to provide care in a safe setting when: 1. Crash cart (a mobile cart that holds medical equipment, supplies, and medications, used in life treating situations) located in Computed Tomography (CT) Room was missing daily check. 2. Coffee maker water filter on Medical Surgical Unit 1st Floor was not dated as per policy and found lying on counter. 3. Water filter for ice/water dispenser in Emergency Department was not dated as per facility policy. 4. Water filter for ice/water dispenser on Medical Surgical Unit 2nd Floor was expired. 5. The staff elevator entering the secured Mother-Baby Unit was found unsecured and accessable to visitors. 6. A “max flow flush” 100 lpm (liters per minute) flow meter (a device delivering high flow oxygen used only for specialized oxygen delivery) was stored in the Telemetry (Tele - area of the hospital that has continuous monitoring) unit supply room next to the 15-liter flow meters (device used for routine oxygen delivery). 7. Two single use scissors were stored opened in the medication room in the Tele unit. 8. Two suture kits were found expired in the Tele supply room. 9. Water filter for the ice machine and the coffee maker used for patients were not dated per facility protocol in the Tele nutrition room. 10. An anesthesia supply cart (a mobile cart that holds medical equipment, supplies, and sharps [any devices with a sharp point or edge that can cut or puncture skin: needles, syringes, scalpel, lancets]) was unlocked in the endoscopy (a medical procedure that uses a flexible tube with a camera to look inside the body) suite. 11. The endoscopy suite supply cabinet was unlocked with sharp supplies inside. 12. a) Preventative Maintenance (PM’s) for the breast milk storage refrigerator, in the nursery, was not competed per the manufacturer’s instructions for use (MIFU’s). 12. b) Preventative Maintenance for the pharmacy medication refrigerator and freezer was not completed per the manufacturer’s instructions for use (MIFU’s). 13. The water filter for the ice machine on Labor and Delivery Unit was expired. 14. A door from the Mother-Baby Unit into Physical Therapy (PT) room was found unlocked and unsecure. 15. Patient 301 medication administration guard rails were not adhered to resulting in Tylenol overdose. 16. One IV pump (medical device that delivers fluids and medications into the patient at a precise rate) had a biomedical engineering sticker for the preventive maintenance (PM) dates were incorrect 17. Ultrasound machine (a machine that uses sound waves to reflect off of body structures to create pictures) found without initial inspection prior to use. 18. Water filter for ice/water dispenser on Intensive Care Unit (ICU) not dated as per facility policy. 19. Water filter for ice/water dispenser on Cardiovascular Intensive Care Unit (CVICU) was expired. These systemic failures resulted in a Tylenol overdose for one patient (Patient 301), causing serious injury, and had the potential to contribute to the patient’s death. Additionally, the facility failed to ensure that care was provided in a safe setting, placing all patients, as well as visitors and staff, at risk of harm. Findings: 1. During a concurrent observation and interview on 11/3/25 at 11:25 am with the Manager of Radiology (MR) in the Computed Tomography (CT) (a type of imaging that uses X-Ray techniques to create detailed images of the body) Room, the crash cart (a mobile cart that holds medical equipment, supplies, and medications, used in life treating situations) was checked. The date of November 1, 2025, was not filled in on the daily checklist. MR stated that the crash cart should be checked daily and that day was not done. During a review of the facility’s policy and procedure titled, “Crash Cart and Emergency Equipment Checks”, dated 6/19/24, indicated in part, “A. Crash carts will be checked daily and documented on the crash cart checklist.” 2. During a concurrent observation and interview on 11/4/25 at 9:38 am with the Trauma Program Manager (TPM) and Perinatal Education Services (PES) in the Medical/Surgical Unit 1st Floor nutrition room, a 3M Water Filtration Product (a filter used to reduce contaminants in drinking water) attached to the coffee machine for patient use was found lying on the counter. Upon inspection of the water filter no installation date was written on the filter. TPM stated that the water filter should have a date of when it was installed written on the filter, but it does not. TPM stated that it is unknown why the water filter is lying on the counter and will investigate that. During an interview on 11/5/25 at 3:22 pm with the Director of Facilities (DOF), DOF stated that all water filters should have a date on the filter with the date that they were installed. DOE stated that water filters are changed annually. DOE stated that he can not indicate when the filter was installed if there was no date written on the filter. During an interview on 11/6/25 at 12:10 pm with Director of Food and Nutrition (DOFN), DOFN stated that the coffee makers are maintained daily by food and nutrition services, but water filters are maintained by facility operations and should have the date written on each filter of when the filter was installed so it is known when it needs to be changed out. DOFN stated that he was unaware of the filter lying on the counter, and the filter should be attached to the wall. During a review of the Manufactures Recommendation for the “3M Water Filtration Product” in the Medical/Surgical 1st Floor Nutrion Room, the Manufactures Recommendation indicated “The disposable filter cartridge MUST be replaced every twelve (12) months, at the rated capacity or sooner if a noticeable reduction in flow rate occurs.” 3. During a concurrent observation and interview on 11/4/25 at 8:51 am with the Trauma Program Manager (TPM) and Perinatal Education Services (PES) in the Emergency Department (ED) hallway, a “Nephros DSU-H” water filter for the water and ice dispensing machine was found to have no installation date written on the filter. TPM stated that the water filter should have a date when it was installed written on the filter, but it does not. During an interview on 11/5/25 at 3:22 pm with Director of Engineering (DOE), DOE stated that all filters should be dated with the date that they were installed. DOE stated that water filters are changed annually. DOE stated that he can not indicate when the filter was installed if there was no date written on the filter. During a review of the facilities Policy and Procedure (P&P) titled “Ice Machine Use in Food Service Areas”, dated 9/10/24, indicates “Facility services monitors and maintains all ice making and dispensing equipment through their preventive maintenance program. Filters are installed and maintained according to manufacturer’s requirements to prevent contaminants from reaching the ice making and dispensing equipment.” During a review of the manufacture’s recommendations for the “NEPHROS DSU-H Water Filter” that was installed in the emergency department, the manufactures recommendations indicate “The Nephros DSU-H Ultrafilter purifies EPA-quality water and makes it suitable for drinking, wound cleansing, surgical handwashing, and medical equipment cleaning. This model-type is a point-of-use ultrafilter capable of retaining bacteria, viruses, and endotoxins for 180 days and ideal for proactive water management.” 4. During a concurrent observation and interview on 11/4/25 at 9:53 am with the Trauma Program Manager (TPM) and Perinatal Education Services (PES) in the Medical Surgical 2nd Floor Nurses Break Room, a “3M Water Filtration Product” for the water and ice dispensing machine was found to have date 2-24 written on the filter. TPM stated that this water and ice dispenser is the only water and ice dispenser located on this floor and is used for the patients. During an interview on 11/5/25 at 3:22 pm with Director of Engineering (DOE), DOE stated that all filters should be dated with the date that they were installed. DOE stated that water filters are changed annually. DOE stated that 2-24 would indicate that the filter is expired. During a review of the facilities Policy and Procedure (P&P) titled “Ice Machine Use in Food Service Areas”, dated 9/10/24, indicates “Facility services monitors and maintains all ice making and dispensing equipment through their preventive maintenance program. Filters are installed and maintained according to manufacturer’s requirements to prevent contaminants from reaching the ice making and dispensing equipment.” During a review of the Manufactures Recommendation for the “3M Water Filtration Product” in the Medical/Surgical 2nd Floor Nurses Break Room, the Manufactures Recommendation indicated “The disposable filter cartridge MUST be replaced every twelve (12) months, at the rated capacity or sooner if a noticeable reduction in flow rate occurs.” 49405 5. During a concurrent observation and interview on 11/04/25 at 09:55 a.m., with Intensive Care Unit Clinical Educator (CE2), during a tour of the Physical Therapy Unit on the second floor. An elevator located off the stepdown unit next to an exit out of the building on the first floor. CE2 states the elevator is a designated “staff elevator” and exits out to the secured mother baby unit and pediatric unit. CE2 states that this elevator does not have a security code or badge access to enter or exit the elevator and that visitors do use this elevator. During the tour a visitor rode down this elevator and exited out the first-floor door. CE2 acknowledged that the mother baby and pediatric units and this elevator is not secure and enters into a secure unit. 6. During a concurrent observation and interview on 11/03/25 at 11:42 a.m. with Director of CE2 and in the first-floor step-down unit clean supply room, a max flow flush 100 lpm Oxygen flow meter was found next to 15-liter meters. CE2 states that the 15-liter meters should be in all patient rooms and acknowledges that the max flow meter should not be stored in the supply room. During an interview on 11/04/25 09:17 with Respiratory Therapist Lead (RT 1), RT 1 stated the max flow flush 100 lpm flow meter found on the Telemetry unit supply room next to the 15-liter flow meters. Chris states the max flow meter is used for “[name of device] high flow system” (specialized respiratory oxygen device). RT 1 states that the max flow meter should not have been stored in the supply room as it could be mistaken for the 15-flow meter. 7. During a concurrent observation and interview on 11/03/25 at 11:34 a.m. with Director of Intensive CE2 and Registered Nurse (RN) 10 in the first-floor step-down unit medication room, observed two single use scissors hanging on the wall and available for use. RN 10 states that the scissors should not be there and acknowledged that they are single use items and should be disposed of. During a review of the facility’s policy and procedure (P&P) titled, “Reprocessing of Single-use Medical Devices (SUDS)”, dated 06/06/25, indicated, “Procedure Summary/Intent: To establish policy and procedure for the reprocessing of single-use medical devices (SUDs). Policy and procedure will be in accordance with the U.S. Food and Drug Administration (FDA) Guidance Document, “Enforcement Priorities for Single Use Devices Reprocessed by Third Parties and Hospitals. Definitions: 1. Single-Use Medical Device (SUD) - A medical device marketed or labeled by the original equipment manufacturer (OEM) to be used on one patient for one procedure and then disposed”. 8. During a concurrent observation and interview on 11/03/25 at 11:34 a.m. with CE2 on the first-floor step-down unit clean supply room, observed 2 expired suture kits in tele supply room accessible for use with expiration date 08/31/25. CE2 stated the suture kits were expired and acknowledged that the suture kits should not be in the clean supply room. During a review of facility P&P titled, “Supply Chain Expired Product Policy”, not dated, indicated, “ POLICY SUMMARY/INTENT: To implement a uniform procedure for the management of expired product and the financial accounting associated with expired product dispositioning. DEFINITIONS: Expired Product - Product whose use by date has passed. POLICY: COMPLIANCE - KEY ELEMENTS, A. Supply Chain Operations 1. All products will be removed from storage prior to expire/use by date and taken to Supply Chain leadership for final disposition.” 9. During a concurrent observation and interview on 11/04/25 at 10:40 a.m. with Director of Facilities (DOF) on the first-floor step-down unit nutrition room, the ice machine water filter was dated 2024. DOF states that filters are changed every 6 months and the ice machines are changed quarterly. DOF acknowledged that the filter was dated 2024. During a concurrent observation and interview on 11/04/25 at 10:41 a.m. with DOF on the first- floor step-down unit nutrition room, the Coffee Machine water filter was observed to be missing a date written on the filter. DOF is unsure who is responsible for cleaning coffee maker and the water filter on the coffee maker. DOF acknowledges that there is no date written on the filter on the coffee maker. During a concurrent interview and record review on 11/04/25 at 3:24 p.m. with DOF, the facilities maintenance record titled [Name of company] dated 02/05 - 02/06/25 was reviewed. The maintenance record indicated the last service was completed on this date. DOF stated that [Name of company] is the contractor who services ice machines and acknowledged that the last time the machine was located on the 1st floor in the step-down unit nutrition room was last serviced eleven months ago. DOF states that facility protocol is to write the date of the last change on the ice machine water filters and acknowledged that the date on the filter was last dated 2024. 39520 10. During a concurrent observation and interview on 11/5/25 at 10:15 a.m., with the director of surgical services (DSS), during a tour of the endoscopy suite in the emergency department, an anesthesia cart was observed to be unlocked. Several supplies including needles and syringes were observed. The DSS acknowledged the cart was unlocked, the supplies were not secure, and they should be. The DSS further acknowledged the cart should be locked when not in use. The facility did not have a policy and procedure for securing supply carts or cabinets containing “sharps” (any devices with a sharp point or edge that can cut or puncture skin: needles, syringes, scalpel, lancets). 11.During a concurrent observation and interview on 11/5/25 at 10:25 a.m., with the director of surgical services (DSS), during a tour of the endoscopy suite in the emergency department, several supply cabinets were observed. The right-side corner cabinet, above the counter, was unlocked. Inside the cabinet several supplies including needles and syringes were observed. The DSS acknowledged the cabinet was unlocked, the supplies were not secure, and they should be. The DSS verbalized and the cabinet lock appeared to be broken and needed to be repaired. The DSS further verbalized the cabinet should be locked when not in use. 12. (a) During a concurrent observation and interview on 11/3/25 at 12:50 p.m., with the charge nurse in labor and delivery (RN 8), during a tour of the nursery, a breast milk refrigerator was observed. A sticker on the side of the refrigerator indicated was approved for use by plant operations. The date inspected and the next inspection due date was not legible on the sticker. When asked if this sticker was a preventative maintenance (PM) sticker, RN 8 verbalized she did not know and would have to ask plant operations. During an interview on 11/4/25 at 3:22 p.m., with the director of facilities (DOF), DOF verbalized when equipment is acquired, the equipment is visually inspected and checked for safety prior to being used and the approval sticker from plant operations is placed on the equipment. DOF verbalized the sticker is not a PM sticker. When asked if PM’s are done on the breast milk refrigerator in the nursery, DOF stated, “No, PM’s are not done on the breast milk refrigerator, they are run to fail.” DOF verbalized if or when the refrigerator fails, the equipment is sent back to the manufacturer and a new one is acquired. During a review of the Manufacturer’s Instructions for Use (MIFU’s) for the breast milk refrigerator indicated ... “Wash the inner compartment with warm water and neutral detergent. Do not allow the control panel, cables or plug to get wet. Never use corrosive detergents, wire brushes, or abrasive scourers to clean your refrigerator. Never use metal or sharp implements to remove debris ...Dry all surfaces thoroughly ...To ensure trouble-free operation, the condenser should be cleaned every three months where appropriate using a vacuum hose. In exceptionally dusty locations, the condenser should be cleaned more often ...” During a review of the facility’s policy and procedure titled, “Maintenance Strategies and Preventative Maintenance” dated 5/5/21, indicated in part ... “It is the policy of the facility and its clinics to identify the activities in writing for maintaining, inspecting, and testing for all medical equipment on the inventory ...Medical equipment within the facilities that is part of the medical equipment inventory program will be scheduled for maintenance based on the strategies chosen for maintenance of that item or class of equipment. Where interval maintenance is chosen, the manufacturer’s recommendations form a basis for the preventative maintenance tests and inspections ...” 12. (b) During an interview on 11/4/25 at 3:22 p.m., with the director of facilities (DOF), DOF verbalized when equipment is acquired, the equipment is visually inspected and checked for safety prior to being used and the approval sticker from plant operations is placed on the equipment. DOF verbalized the sticker is not a PM sticker. When asked if PM’s are done on the medication refrigerators and the pharmacy medication refrigerator and freezer, DOF stated, “No, PM’s are not done on medication refrigerators or the pharmacy refrigerator/freezer, they are run to fail.” DOF verbalized if or when the refrigerators and freezers fail, the equipment is sent back to the manufacturer, and a new one is acquired. During a review of the Manufacturer’s Instructions for Use (MIFU’s) for the pharmacy refrigerator indicated ... “Maintenance tasks should be completed according to the schedule below ... The preventive maintenance schedule provides recommended minimum requirements. Regulations or physical conditions at your organization may require maintenance items be performed more frequently, or only by designated service personnel ...Before performing maintenance, protect items in refrigerator from extended exposure to adverse temperature ...Allow refrigerator temperature to stabilize at setpoint after performing service or after extended door opening ...Quarterly: Test the high and low temperature alarms ...Test the power failure alarm ...Check the temperature calibration on the monitor and change it if necessary ...Clean condenser grill ...Inspect ground strap ...Annually: Examine the probe bottles and clean or replace if necessary ...Every 2 Years: Replace monitoring system back-up battery ...As Needed: Test the door alarm ...Check the back-up battery for the chart recorder after an extended power failure and change it if necessary, or change the battery if it has been in service for one year ...Check the level of solution in the probe bottles. Refill or replace solution if necessary ...Check the chamber lights and replace if necessary ...Clean the door gaskets, interior, and exterior of the refrigerator ...If applicable, test the ground fault circuit interrupter on the internal outlet ....” During a review of the Manufacturer’s Instructions for Use (MIFU’s) for the pharmacy freezer indicated ... “Cleaning: To clean the inside of the appliance, use a soft cloth and a solution of a tablespoon of baking soda to one quart of water or a mild soap solution or some mild detergent ...clean the outside with a soft, damp cloth and some mild detergent ...it is important to keep the area where the door seals against the cabinet clean to ensure a tight seal ...clean this area with soapy cloth. Rinse with a damp cloth and let dry ...Defrosting: This appliance should be defrosted approximately twice a year of when a ¼ inch layer of frost has formed ...” 13. During an interview on 11/4/25 at 3:22 p.m., with the director of facilities (DOF), DOF verbalized the preventative maintenance (PM) on the ice machines are done semi-annually. DOF verbalized the vendor comes to the facility and performs the PM. DOF verbalized the water filter is also changed at the same time, when the PM is performed. DOF further verbalized the water filter should be dated when the filter was changed. During an observation on 11/5/25 at 8:45 a.m., on the labor and delivery unit, during a tour of the patient nourishment room, the ice machine was observed. Under the sink, the water filter for the ice maker was observed to have a date of 12/24 written on the filter. During a concurrent interview and record review, on 11/5/25, at 9:55 a.m. with the DOF, the ice maker PM invoice, for the labor and delivery unit, dated 10/2/25 -10/7/25, was reviewed. DOF acknowledged there was no documentation on the PM invoice that the water filter had been changed. DOF was informed that the date of the last water filter change, on the ice machine in labor and delivery, was 12/24. DOF verbalized the water filter should have been changed with the PM and acknowledged the water filter had expired. During a review of the facility’s policy and procedure titled, “Ice Machine Use in Food Service Areas” dated 10/14/24, indicated in part ... “A. Ice which is used in connection with food or drinks shall be from a sanitary source and shall be handled and dispensed in a sanitary manner ...B. Facilities Services Deep Cleaning, Sanitation, and Servicing of Ice Makers: 1. Facility Services monitors and maintains all ice making and dispensing equipment through their preventative maintenance program ... 2. Competent facilities personnel or vendor will ensure ice making equipment is cleaned, sanitized, and serviced according to manufacturer’s guidelines. Filters are installed and maintained according to manufacturer’s requirements to prevent contaminants from reaching the ice making and dispensing equipment ...” 14. During a concurrent observation and interview on 11/3/25 at 1:00 p.m., with the charge nurse in labor and delivery (RN 8) and the clinical educator (CE), during a tour of the Mother-Baby unit, a physical therapy (PT) room was observed in the hallway. One entrance to the PT room was on the outside of the locked door to the mother baby unit. That door entrance is locked and can only be entered by staff with badge access. The second entrance to the PT room was in the hallway of mother-baby. The second door entrance was observed; the door was unlocked and was opened. When asked if the PT room’s second entrance door should be locked, RN 8 verbalized yes it should be locked. RN 8 further acknowledged the mother-baby unit is a locked unit. In the same hallway there is a pediatric overflow room that sometimes is used for pediatric patients. During a concurrent observation and interview on 11/4/25 at 12:38 p.m., with the Women’s Services Director (WSD), the second entrance to the PT room was observed in the hallway of the mother baby unit. WSD was informed that the second entrance door was unlocked yesterday. WSD verbalized the mother baby unit was a locked unit. WSD verbalized the infants and the pediatric patients up to age 2 years old, wear a security system transmitter band to protect them from abduction. WSD verbalized the security system transmitter band would alarm if there was an attempt to abduct an infant and or a pediatric patient going through the PT room unlocked door. When asked about the pediatric patients, older than two years old, who are not wearing the security system transmitter band, would the alarm still activate, WSD verbalized no, the alarm would not activate if the patient was not wearing a security system transmitter band. WSD acknowledged the pediatric patients without a security transmitter band are not secure if the PT room door is unlocked and further acknowledged the alarm would not be activated. WSD further verbalized would need to confirm with the emergency management manager (EMM) about the alarm activation. During an interview on 11/4/25, at 1:00 p.m., with the emergency management manager (EMM), EMM verbalized the second entrance PT door needs to be locked at all times. EMM acknowledged the PT second entrance door was not locked yesterday. EMM confirmed pediatric patients who were not wearing a security system transmitter band would not activate an alarm and may not be secure if the PT door was unlocked. During a review of the facility’s policy and procedure titled, “Infant and Pediatric Security” dated 11/09/23, indicated in part ... “The facility will provide a safe and secure environment for all neonates, infants, their birth parent, and pediatric patients. The facility will take reasonable measures to prevent the abduction of a neonate, infant or child from any women, infant and pediatric units and appropriate actions will be taken should abduction occur ...G. Access and Security Devices: 1. Security system transmitter bands will be applied in Mother Baby when the well newborn is transferred to the unit ...Infants in the NICU will be banded when they transition from an incubator to an open bed, or when medically stable if admitted to an open bed ...Pediatric patients that are two years old or under will be banded upon admission. Parents may refuse security banding after explanation of security risks and procedures ...4. Entry and exit to infant and childcare areas will be limited to one constantly monitored entry point point ...5. All staff and visitors will enter and exit via the designated monitored entrance ...” 15. During a review of Patient 301’s medical record indicated, a 69-year-old male admitted to the Emergency Department (ED) on 9/13/25, secondary to blunt trauma (injury to the body caused by a forceful impact) from a motor vehicle accident (MVA). Patient 301 had multiple fractures of the ribs, cervical spine, and sternum (long bone in the middle of the chest). In the ED on 9/13/25 at 11:47 p.m. the ED physician orders included Tylenol 1000 mg intravenous (IV-via needle to the vein) every 6 hours. On 9/14/25 at 8:59 a.m., Patient 301 was seen by the Trauma Medical Doctor and ordered Tylenol 1,000 mg (milligram - unit of measure) every 6 hours, 2 tablets (tabs) po (by mouth). On 9/14/25, from the ED, Patient 301 was transferred to the Step-Down Unit (unit which provides intermediate care between the ICU and general medical-surgical floor). Both orders were verified by Pharmacy on 9/14/25 at 9:22 a.m. During a review of Patient 301’s medical record indicated, Patient 301 received the following doses of Tylenol: On 9/14/25 at 12:09 a.m. 1000 mg IV in the ED On 9/14/25 at 6:44 a.m. 1000 mg IV in the Step-Down Unit (SDU) On 9/14/25 at 1:29 p.m. 1000 mg po in the SDU On 9/14/25 at 3:15 p.m. 1000 mg IV in the SDU On 9/14/25 at 10:00 p.m. 1000 mg IV and 1000 mg po administered simultaneously (same time) by a registered nurse in SDU. On 9/14/25 at 11:24 p.m. 1000 mg IV and 1000 mg po administered simultaneously by a registered nurse while Patient 301 was in SDU. On 9/15/25 at 6:25 a.m. 1000 mg IV and 1000 mg po were administered simultaneously by a registered nurse while Patient 301 was in SDU. Further review of Patient 301’s record indicated, on 9/15/25, Patient 301 was transferred from the SDU to the Medical-Surgical Unit (MS), when another registered nurse noticed the patient had two sets of Tylenol orders-one for IV and the other PO. On 9/15/25 at 11:59 a.m., 1,000 mg po was administered in the MS unit by a registered nurse. Review of the Physician Discharge Summary Notes dated 9/19/25 indicated in part, “after the patient underwent a successful resuscitation and taken to the ICU, the patient’s laboratory evaluation showed acute anemia (low red blood cell count, thrombocytopenia (low blood platelets leading to bleeding), and the liver function test was consistent with liver failure. Patient received blood transfusion, but with bowel ischemia (not enough blood flow to the intestines), and underwent an emergent surgical procedure secondary to venous thrombosis (blood clot in vein). Patient never recovered fully post-surgery and expired on 9/19/25.” During an interview on 11/5/25 at 9:07 a.m., with the administrative director of quality management (ADQM), ADQM was asked about the adverse event that occurred and what went wrong when Patient 301 received too much Tylenol. ADQM verbalized medication guardrails needed to be followed. ADQM verbalized when a medication alert comes up the alert should not be ignored or bypassed. ADQM verbalized if pharmacy receives a duplicate medication order, an alert will pop up, and it should not be bypassed. ADQM verbalized the medication alerts and guardrails were ignored and bypassed resulting in the Tylenol overdose. ADQM verbalized the physician put in a duplicate medication order, the pharmacy verified the order and ignored the alerts, and nursing administered the Tylenol while ignoring the alerts. ADQM verbalized staff need education on medication alerts and education on the maximum dose of Tylenol that can be given in 24 hours. ADQM verbalized there were system issues and culture issues. ADQM verbalized several staff had been working at the facility for years and there was a culture of not speaking up or questioning an order. ADQM verbalized needing to change the culture and stated, “It’s ok to speak up if you have questions about giving a medication and it’s ok to stop and pause and ask questions.” During a review of the facility’s P&P titled, “Medication Administration,” dated 12/13/2024, indicated, “It is the policy of {name of facility} Nursing Division to ensure that licensed nurses follow accepted standards of practice in the administration of medications to patients ... prior to administration verify the medication for route, dose and frequency ... the prescriber should be contacted for further clarification ... the review consists of drug appropriateness, therapeutic duplication ... other contraindications, variation from hospital criteria for use and other relevant medication-related issues or concerns ... all areas of concern, issues or questions are clarified with the individual prescriber before the medication are dispensed/administered ... the medication will be given at the right time ...” During an interview on 11/5/25 at 9:30 a.m., with the ADQM, ADQM was asked about transferring patients to different units within the hospital, and physician medication orders being discontinued, and if there was a policy or process being followed. ADQM verbalized there was no facility process or policy for physician medication orders being discontinued; when a patient transfers to another unit within the hospital. ADQM verbalized that best practice would have been for the physician to discontinue the medication orders and write new medication orders when a patient transfers to another unit. ADQM acknowledged the physician medication orders were not discontinued for Patient 301 when transferred from the Emergency Department to the Step-Down Unit. During a review of the facility’s memo from the Chief Medical Officer (CMO) dated 9/23/25, the memo indicated... “This is a reminder for the medical staff ... All medications ordered should be discontinued upon transfer to a different level of service and new orders written. This applies to movement of patients from the ED to inpatient or observation units, as well as to patients transferred between levels of service in-house (ICU and OR) ... Medication reconciliation is the responsibility of the admitting physician and should be completed for every admission when orders are written ...” During a concurrent interview and record review, on 11/10/25, at 12:35 p.m., with the CMO, the CMO stated the information that is written in the memo are not new practices the practices listed on the memo have been in place, this memo was sent with these practices as reminders to the medical staff, we wanted to ensure there was a more standardized practice. CMO acknowledged and confirmed that the practices listed on the memo were already in practice, not new practices just reminders to the medical staff. 40678 16. A review of that facility’s policy and procedure (P&P) titled “Maintenance Strategies and Preventive Maintenance”, dated 4/15/24 indicated “It is the policy of the Facility ... to identify the activities in writing for maintaining, inspecting, and testing for all medical equipment on the inventory ... The Director of Biomedical Engineering ... is responsible for determining preventive maintenance strategies associated with the medical equipment maintenance program ...” During a concurrent observation and interview on 11/3/25 at 1:05 p.m., with the stroke coordinator (SC), in the operating room the IV pump had a biomedical engineering sticker that indicated last (PM), Last PM: Date 7/25 and next PM Due: 9/25. SC acknowledged and confirmed that the next PM date indicated it should have been done 9/25 and that the PM was past the due date. During an interview with the biomedical engineering manager (BEM) on 11/3/25 at 5:00 p.m., the BEM acknowledged and confirmed the biomedical engineering sticker on the IV pump should have the correct dates on it, BEM stated the staff must have made an error. 35399 17. A review of that facility’s P&P titled “Medical Equipment Maintenance and Management”, dated 5/5/21 indicated “All medical equipment used for treatment, diagnosis, monitoring and care of patients, operated within or by the facility and the facilities clinics must pass an inspection for safety, performance, and compliance with the manufacturers specifications prior to use with patients.” During a concurrent observation of an ultrasound machine in the ICU and interview with the MSS on 11/3/25 at 12:54 p.m., the MSS reported this is a new ultrasound machine which is used by the physicians to diagnose ICU patients immediately or during emergent situations. The ultrasound machine was inspected for a preventive maintenance (PM) date or label. However, no label was found on the US machine. During an interview with the biomedical engineering manager (BEM) on 11/4/25 at 4:23 p.m., the BEM was asked about the ultrasound machine’s PM. The BEM reported that the ICU US machine is new and should have had an initial inspection before being used by the physicians. However, the biomed department does not perform those inspections and is not responsible for the ultrasound machines. The radiology manager is responsible for the ultrasound machines. During an interview with the manager of radiology (MR) on 11/6/25 at 11:23 a.m., the MR was asked about the ICU ultrasound machine PM or initial inspection. The MR stated “No, I don’t know anything about the ICU ultrasound machine. I am not responsible for that machine. I am only responsible for the ultrasound machines in the imaging services. The ICU ultrasound machine has not had an initial inspection and/or PM by the biomed, facilities services or the manufacturer’s vendor.” During an interview with the manager of accreditation and regulatory compliance (MARC) on 11/6/25 at 11:35 a.m., MARC was made aware that it was not safe for patients to be diagnosed with an US machine that has not had an initial inspection to assess if is functioning correctly. MARC acknowledged and agreed that the US machine should have been inspected before being used on patients. A review of the facility’s P&P titled “medical equipment management plan”, dated 4/7/25, indicated “Biomedical services schedules and completes all calibration, inspection, and maintenance activities required to assure safe, reliable performance of the medical equipment included under the contractual agreement between a third-party biomedical service and [hospital’s name].” 18. During a concurrent observation of the ICU ice machine filter and interview with the MSS on 11/3/25 at 12:44 p.m., the water filter was observed without any labeling with the date the filter was changed. The MSS reported that the water and ice from this ice machine is provided to the patients in this unit. The MSS was asked how we know when this water filter has been changed if there is no label with the filter change date on the filter. The MSS confirmed the filter does not have a label or date on filter. MSS stated “I don’t know. But I agree the filter does not have a label or date on it.” During an interview with the director of facilities (DOF) on 11/3/25 at 3:09 p.m., the DOF was asked how we know when this water filter has been changed if there is no label with the filter change date on the filter. The DOF stated “When the filter is changed the date is written on the filter indicating the date the filter was changed. If there is no date on the filter, then we do not know when the filter was changed. Normally, filters are changed annually.” A review of the facility P&P titled “Ice Machine Use in Food Service Areas”, dated 9/10/24, indicates “Facilities services monitors and maintains all ice making and dispensing equipment through their preventive maintenance program .... Filters are installed and maintained according to manufacturer’s requirements to prevent contaminants from reaching the ice making and dispensing equipment.” 19. A review of the facility P&P titled “Ice Machine Use in Food Service Areas”, dated 9/10/24, indicates “Facilities services monitors and maintains all ice making and dispensing equipment through their preventive maintenance program .... Filters are installed and maintained according to manufacturer’s requirements to prevent contaminants from reaching the ice making and dispensing equipment.” During a concurrent observation of the CVICU ice machine filter and interview with the MSS on 11/3/25 at 3:21 p.m., the water filter was observed with the date 5/24 written on filter indicating the filter was changed on this date. The MSS acknowledged the observation and stated “Yes, I agree the water filter is past due. The filter should have been changed in May 2025, and it wasn’t.” The MSS further agreed it was not safe for patients to consume ice or water that might have contaminants.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(4)(ii) [The use of restraint or seclusion must be--] (ii) implemented in accordance with safe and appropriate restraint and seclusion techniques as determined by hospital policy in accordance with State law. This Standard is not met as evidenced by: 35399 Based on interview and record review, the facility failed to ensure staff implemented their policies and procedures (P&Ps) for three of three sampled patients (Patients 101, 102, and 401) when: 1. Patient 101 was missing documentation for restraints (soft limb holders used to limit movement of the wrists or ankles) for the entire day shift on 10/31/25. 2. Patient 102’s wrist restraints were not monitored every two hours on 11/2/25. 3. Patient 102 was placed in restraints on 10/27/25, but there was no physician’s order to renew the restraints. 4. Patient 102’s restraint assessment was not conducted on 10/26/25. 5. Patient 401 did not have a physician’s order for a one-to-one (1:1) observer (a safety measure where one staff member is assigned to continuously monitor a patient) while under observation. 6. Patient 401’s observer did not document monitoring every 15 minutes as required. These failures had the potential to result in patients being unnecessarily restrained, violating their rights and possibly causing physical or psychological harm. Findings: 1. A review of the facility P&P titled “Restraint Management (Mechanical, Chemical, Seclusion) dated 2/3/25, in the Ongoing Monitoring/Documentation part indicated “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 restraints, and skin integrity ...” During a concurrent review of Patient 101’s medical record and interview with the medical surgical supervisor (MSS) on 11/4/25 at 12:41 p.m., record indicated patient was placed on 2-point wrist restraints on 10/26/25. On the Restraints Flowsheet part of the record indicated on 10/31/25 from 6:00 a.m. to 8:00 p.m., there was no documentation on the application, assessment and monitoring of the restraints. The MSS confirmed the patient had bilateral wrists restraints on and there was no documentation of the restraints at all for 16 hours on this date. 2. A review of the facility P&P titled “Restraint Management (Mechanical, Chemical, Seclusion) dated 2/3/25, in the Restraint Considerations- Non-Violent/Non- Self- Destructive part indicated “Assessment and monitoring will be conducted at minimum, every (2) two hours.” During a concurrent review of Patient 102’s medical record and interview with the MSS on 11/4/25 at 10:31 a.m., record indicated patient was placed on 2-point wrist restraints on 10/24/25. On the Restraints Flowsheet part of the record indicated on 11/02/25, patient’s restraints were not assessed and monitored at 6:00 p.m. Patient’s restraints were assessed at 4:00 p.m., then at 8:00 p.m. But there was no 6:00 p.m. assessment and documentation for the restraints in the record. The MSS acknowledged and confirmed that the 6:00 p.m. assessment was missing thus patient’s restraints were not assessed and monitored every two hours. 3. A review of the facility P&P titled “Restraint Management (Mechanical, Chemical, Seclusion) dated 2/3/25, in the Restraint Considerations- Non-Violent/Non- Self- Destructive part indicated “Orders will be renewed every three (3) days if continued restraints are needed.” During a concurrent review of Patient 102’s medical record and interview with the MSS on 11/4/25 at 10:02 a.m., the medical record indicated Patient 102 was placed in 2-point wrist restraints on 10/24/25 at 6:00 a.m. Patient 102’s restraints remained on. Three days from the initiation of the restraints would have been 10/27/25 at 6:00 a.m., for which restraints renewal order was required. The physician’s renewal order for restraints was obtained on 10/28/25 at 11:35 p.m., (41.5 hours) later. The patient remained on restraints for 41.5 hours without a physician’s renewal order. The MSS confirmed there was no physician’s restraints renewal order on 10/27/25 by 6:00 a.m. and the patient was on restraints for 41.5 hours without an order. 4. A review of the facility P&P titled “Restraint Management (Mechanical, Chemical, Seclusion) dated 2/3/25, in the Ongoing Monitoring/Documentation part indicated “Ongoing assessments/interventions are documented according to the frequency appropriate to the patients’ condition; such as but not limited to circulation, range of motion, hydration, elimination needs, injuries due to restraints, and skin integrity ...” During a concurrent review of Patient 102’s medical record and an interview with the Medical-Surgical Supervisor (MSS) on 11/4/25 at 10:36 a.m., the record indicated Patient 102 was in bilateral wrist restraints. The Restraint Patient Assessment Flowsheet showed that on 10/26/25 at 4:00 a.m., no restraint assessment was performed or documented. The MSS confirmed that there was no assessment or documentation of the restraints in the medical record. 49405 5. During a concurrent interview and record review on 11/04/25 at 4:00 p.m. with Intensive Care Unit Clinical Educator (CE) 2, Patient 401’s “Constant Observer Flow Sheet”, dated 10/30/25 was reviewed. The Flow Sheet indicated one-to-one (1:1) observation (one staff member is assigned to watch one patient closely at all times to keep them safe) was initiated on 10/30/25 at 2:30 p.m. During a concurrent interview and record review on 11/04/25 at 4:00 p.m. with CE 2, Patient 401 “Physician Orders” were reviewed. The orders indicated the initial order for 1:1 was placed on 11/31/25 at 6:33 a.m. CE2 stated that an order is needed every 24 hours for a 1:1 observation and acknowledged there was not an order placed on 10/30/25 when 1:1 observation was initiated. During a review of the facility policy and procedure (P&P) titled, “Patient Safety Attendant”, dated 10/13/25, indicated in part, “DEFINITIONS: A. Patient Safety Attendant (PSA): Staff assigned to stay with one (1:1) patient within close proximity or two patients within line of sight (LOS) for safety reasons because the patient is confused, agitated, is disrupted or attempts to disrupt therapy, gravely disabled or is a high fall or flight risk. POLICY: COMPLIANCE - KEY ELEMENTS, B. A physician order is required for a PSA for one (1:1) or two (close proximately) patients, however nursing staff may initiate PSA while contacting physician for an order.” 6. During a concurrent interview and record review on 11/04/25 at 4:10 p.m. with CE 2, Patient 401’s “Constant Observer Flow Sheets”, were reviewed. Flow Sheets were completed for 10/30/25, 11/01/25, 11/02/25, and 11/03/25. CE 2 stated that constant observer flow sheets document every 15-minute monitoring and should be completed when a patient is on 1:1 observation. CE 2 states that there is not a flow sheet for 10/31/25 and acknowledged that it should have been completed. During a concurrent interview and record review on 11/04/25 at 4:12 p.m. with CE 2, Patient 401’s “Physician Orders” were reviewed. The order indicated orders were placed for 1:1 constant observation on 10/31/25, 11/1/25, 11/02/25 and 11/03/25. CE 2 states that a flow sheet should have been completed for these dates. During a review of the facility policy and procedure (P&P) titled, “Patient Safety Attendant”, dated 10/13/25, indicated in part, “PROCEDURE: H. PSAs will adhere to the following care guidelines: ... 6. The PSA will document care every fifteen minutes on the PSA Monitoring Form”.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(12) When restraint or seclusion is used for the management of violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others, the patient must be seen face-to-face within 1-hour after the initiation of the intervention -- o By a-- - Physician or other licensed practitioner; or - Registered nurse who has been trained in accordance with the requirements specified in paragraph (f) of this section. This Standard is not met as evidenced by: 35399 Based on interview and record review, the facility failed to ensure that Emergency Department (ED) nursing staff monitored one of three sampled patients (Patient 101) every 15 minutes, as required by the facility’s policy and procedure (P&P), when Patient 101 was placed in 4-point restraints (physically immobilize a person by securing all four limbs, typically with soft restraints on wrists and ankles to keep them safe). Additionally, staff failed to obtain the correct physician order for the use of restraints. This facility failure placed Patient 101 at an increased risk of self-harm without timely staff intervention or awareness. Findings: A review of the facility P&P titled “Restraint Management (Mechanical, Chemical, Seclusion) dated 2/3/25, in the Restraints Considerations-Violent/Self-Destructive part indicated “4. Patients with violent/self-destructed behavior will be monitored every 15 minutes to include documentation of patient status and well-being.” A review of Patient 101’s medical record was conducted on 11/4/25. The ED Physician Note dated 10/26/25 indicated “Patient is a 33-year-old woman with a previous history of traumatic brain injury, seizure disorder and illicit drug use who presents to the ED on 10/26/25 for evaluation after she sustained a seizure at home. Patient has been known to be combative in the past when she is in a post-ictal (the recovery period following an epileptic seizure) state ... Since arrival the patient has been uncooperative. On 10/26/25 at 12:50 p.m., while waiting for patient’s mother to arrive, the patient had a generalized seizure and was combative in her postictal state. Patient required 4-point restraints, using soft restraints. At 1:06 p.m., Patient continues to be extremely agitated and combative ... At 3:14 p.m., Patient clearly will need admission to the hospital but remains very combative ...” The physician’s order for restraints, dated 10/26/25 at 12:49 p.m., indicated the use of non-violent restraints, despite documentation in the ED physician note describing the patient’s violent behavior and the use of 4-point restraints. During a concurrent review of patient’s restraints record and interview with the ED/ICU director (EDICUD) on 11/4/25 at 11:25 p.m., in the Restraints Flowsheet part of the record indicated that on 10/26/25 at 1:28 p.m., 4-point restraints were applied to the patient. Bilateral upper and lower extremities were restrained with soft restraints. The patient’s restraints assessments were conducted at 3:00 p.m., and then at 4:30 p.m. The EDICUD acknowledged and confirmed the patient was not monitored every 15 minutes while on the 4-point violent behavioral restraints. Furthermore, the EDICUD also confirmed the restraints physician order should have been for violent/destructive behavior restraints and not for non-violent/non-destructive restraints.”

“DATA COLLECTION & ANALYSIS CFR(s): 482.21(a), (b)(1),(b)(2)(i), (b)(3) (a) Program Scope (1) The program must include, but not be limited to, an ongoing program that shows measurable improvement in indicators for which there is evidence that it will improve health outcomes ... (2) The hospital must measure, analyze, and track quality indicators ... and other aspects of performance that assess processes of care, hospital service and operations. (b)Program Data (1) The program must incorporate quality indicator data including patient care data, and other relevant data such as data submitted to or received from Medicare quality reporting and quality performance programs, including but not limited to data related to hospital readmissions and hospital-acquired conditions. (2) The hospital must use the data collected to-- (i) Monitor the effectiveness and safety of services and quality of care; and .... (3) The frequency and detail of data collection must be specified by the hospital’s governing body. This Standard is not met as evidenced by: 35399 Based on interview and record review, the facility failed to ensure that the Intensive Care Unit (ICU) medication titration Performance Improvement Project (PIP) data was properly measured, accurately analyzed, and reflective of the actual improvement needs in medication titration practices. This failure resulted in data showing the PIP met its benchmark of 95%, despite clear evidence that actual medication titration practices did not align with the reported results. Findings: A review of the facility P&P titled “Patient Safety and Quality Assurance Performance Improvement (QAPI) Plan, dated 6/11/25, indicates “To Provide guidelines for collecting, analyzing, and using data to identify, address, and monitor performance to continually improve the quality of care provided by the hospital ...” During a concurrent review of the medication titration PIP and interview with the ED/ICU director (EDICUD) on 11/5/25 at 11:47 a.m., the EDICUD reported conducting a medication titration PIP to address the concerns regarding the medication titration orders. The EDICUD was asked to share the data collection audits, and/or tools used to conduct the PIP. The EDICUD confirmed that they did not use any audit tools to collect data for this PIP. Upon reviewing the PIPs third quarter monthly performance percentage report. PIP’s benchmark performance was set at 95%. The report indicated that in July 2025, their performance was 96%. In August 2025, their performance was 97%. In September 2025, their performance was 96.28%. Concerns were communicated to the ED/ICU Director (EDICUD) regarding the accuracy of the medication titration data collection and analysis... because according to their performance report the ICU performed higher than the benchmark. However, audits were performed in the ICU for the titration of Levophed (medication to increase blood pressure), Precedex (sedative and analgesic medication) and Propofol (sedative) medication and three out of three medications were not titrated correctly. This means their medication titration PIP data results are not correlating with the medication titration practice in the ICU. The EDICUD acknowledged the medication titration practice does not match their performance report and stated, “O.K. I understand.””

“QUALITY IMPROVEMENT ACTIVITIES CFR(s): 482.21(b)(2)(ii), (c)(1), (c)(3) (b) Program Data (2) [The hospital must use the data collected to - .....] (ii) Identify opportunities for improvement and changes that will lead to improvement. (c) Program Activities (1) The hospital must set priorities for its performance improvement activities that-- (i) Focus on high-risk, high-volume, or problem-prone areas; (ii) Consider the incidence, prevalence, and severity of problems in those areas; and (iii) Affect health outcomes, patient safety, and quality of care. (3) The hospital must take actions aimed at performance improvement and, after implementing those actions, the hospital must measure its success, and track performance to ensure that improvements are sustained. This Standard is not met as evidenced by: 35399 Based on interview and record review, the facility failed to ensure that the ICU leadership prioritized their Performance Improvement Projects (PIPs) to address high-volume, high-risk, and problem-prone areas. This failure resulted in the ICU conducting PIPs that did not address these critical priorities, limiting the effectiveness of its quality improvement efforts. Findings: A review of the facility P&P titled “Patient Safety and Quality Assurance Performance Improvement (QAPI) Plan, dated 6/11/25, indicates “2. Leadership is responsible for the following ...c. Setting priorities for performance improvement that include but are not limited to the following: i. High-volume processes, ii. High-risk processes, iii. Problem-prone processes ...” During a concurrent review of the ICU’s PIPs and interview with the ED/ICU director (EDICUD) on 11/5/25 at 10:23 a.m., the EDICUD reported that the ICU is conducting a medication titration PIP for this year.. The EDICUD was asked which priority this PIP was focusing on. The EDICUD reported the priority for this PIP was “Appropriateness, Effectiveness & Safety.” The EDICUD confirmed the medication titration PIP was the only PIP being conducted for this year. Concerns were communicated to the EDICUD that the ICU was not conducting PIPs focused on high-volume, high-risk, and problem-prone areas. The EDICUD acknowledged the concern and stated, “I understand.””

“QAPI PERFORMANCE IMPROVEMENT PROJECTS CFR(s): 482.21(d) As part of its quality assessment and performance improvement program, the hospital must conduct performance improvement projects. (1) The number and scope of distinct improvement projects conducted annually must be proportional to the scope and complexity of the hospital’s services and operations. (2) A hospital may, as one of its projects, develop and implement an information technology system explicitly designed to improve patient safety and quality of care. This project, in its initial stage of development, does not need to demonstrate measurable improvement in indicators related to health outcomes. (3) The hospital must document what quality improvement projects are being conducted, the reasons for conducting these projects, and the measurable progress achieved on these projects. (4) A hospital is not required to participate in a QIO cooperative project, but its own projects are required to be of comparable effort. This Standard is not met as evidenced by: 35399 Based on interview and record review, the facility failed to ensure that Performance Improvement Projects (PIPs) were conducted using a defined model or methodology that included the rationale for initiating the project and measurable progress achieved. This failure resulted in the facility services conducting PIPs without a structured approach that documented the reasons for the project and tracked its progress. Findings: During a concurrent review of the facility’s Quality Assurance Performance Improvement (QAPI) plan dated 5/7/25 and interview with the administrative director of quality management (ADQM) on 11/5/25 at 10:05 a.m., the ADQM reported that the quality department selected to use the Plan-Do-Study-Act (PDSA) model to conduct the PIPs throughout the facility’s services. This model is well known in healthcare because it includes the reason the PIP is being conducted and monitors its progress. The PDSA Model is a cyclical model for continuous improvement. Plan: Develop a plan to improve a process, including identifying interventions and monitoring indicators. Do: Implement the planned changes. Study: Collect and analyze data to evaluate the results of the changes. Act: Make necessary modifications to the plan to ensure improvement and implement the modified plan. The ADQM was asked the reason the PDSA model was not included in the QAPI plan. The ADQM stated “I don’t know why its not included but this is the model the quality department has adopted to use.” The ADQM further reported the services leaders are responsible in conducting their service PIPs. An audit of the PIPs for the emergency department (ED), intensive care unit (ICU), labor and delivery (L&D), Imaging and outpatient services was conducted. a) During a concurrent review of the ED medication reconciliation PIP and interview with the ED/ICU director (EDICUD) on 11/5/25 at 11:50 a.m., the EDICUD acknowledged and confirmed not using the PDSA model to conduct the medication reconciliation PIP. b) During a concurrent review of the ICU medication titration PIP and interview with the ED/ICU director (EDICUD) on 11/5/25 at 11:10 a.m., the EDICUD acknowledged and confirmed not using the PDSA model to conduct the medication titration PIP. c) During a concurrent review of the radiology repeat rates PIP in the Imaging Service and an interview with the Manager of Radiology (MoR) on 11/5/25 at 12:10 p.m., the MoR acknowledged and confirmed that the PDSA model was not used to conduct the radiology repeat rates PIP. Furthermore, the MoR confirmed that the PDSA model was also not used to conduct the ultrasound high-level disinfection (HLD) PIP in the Ultrasound Service. d) During a concurrent review of the history & physical (H&P) form PIP conducted in the outpatient service and interview with the out-patient service director (OPSD) on 11/5/25 at 4:15 p.m., the OPSD acknowledged and confirmed not using the PDSA model to conduct the H&P form PIP. On 11/5/25 at 4:30 p.m., the ADQM acknowledged and confirmed that only the L&D service leader is using the PDSA model to develop the L&D PIP. However, the rest of the service leaders (ED, ICU, Imaging, and outpatient) have not used the PDSA model when they developed and while conducting their PIPs. The ADQM stated, “They will be now.””

“QAPI EXECUTIVE RESPONSIBILITIES CFR(s): 482.21(e)(1), (e)(2), (e)(5) The hospital’s governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative officials are responsible and accountable for ensuring the following: 1) That an ongoing program for quality improvement and patient safety, including the reduction of medical errors, is defined, implemented, and maintained . (2) That the hospital-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety and that all improvement actions are evaluated. (5) That the determination of the number of distinct improvement projects is conducted annually. This Standard is not met as evidenced by: 35399 Based on interview and record review, the facility failed to ensure that every service, including Labor and Delivery (L&D), conducted a Performance Improvement Project (PIP) annually. This failure resulted in L&D not conducting a PIP as required, and had the potential to limit the identification and resolution of quality and safety issues within the service. Findings: A review of the facility P&P titled “Patient Safety and Quality Assurance Performance Improvement (QAPI) Plan, dated 6/11/25, in part A (5) indicated, “The quality and safety committee is responsible for the following: c. Directing ongoing hospital wide performance improvement activities.” During a concurrent review of the L&D PIPs and interview with the women service director (WSD) on 11/5/25 at 12:20 p.m., the WSD was asked to share the PIPs being conducted in the L&D. The WSD indicated there have not been any PIPs conducted in the L&D this year. During an interview with the administrative director of quality management (ADQM) on 11/5/25 at 12:21 p.m., the ADQM was made aware that there were concerns the L&D had not conducted any PIPs this year. The ADQM acknowledged the concern and stated “Okay.””

“MEDICAL STAFF BYLAWS CFR(s): 482.22(c) The medical staff must adopt and enforce bylaws to carry out its responsibilities. The bylaws must: This Standard is not met as evidenced by: 13095 Based on record review, interview with Medical staff, policy and procedure review and review of the hospital’s Medical Staff ByLaws Rules and Regulations; Two of the hospital’s Physician’s failed to follow the hospital’s policies and procedures and the hospital’s Rules and Regulation regarding two Tylenol medication orders. This failure had the potential to result in one patient developing liver damage from excessive doses of Tylenol (Acetominphen), during their hospital stay. Findings include: In September of 2025, a 69-year-old patient who had been brought into the hospital by California Highway Patrol after a head-on freeway collision on 9/13/2025 had been admitted into the hospital’s Emergency Room. The Emergency Room (ED) physician (MD-1), who saw Patient-301, on 9/13/2025 at 11:47 pm had written an order for Tylenol 1,000 milligrams (mg) every 6 hours via Intravenous (IV) for 30 days. Review of the hospital’s Bylaws and Rules and Regulations, dated 2/2025, read: “ ...A-1.3 A member of the medical staff shall be responsible for the medical care and treatment of each patient in the hospital, for prompt completeness and accuracy of the medical record ...Automatic stop order procedures shall be complied with ...See also Pharmacy Policy, Automatic Stop Orders ....”. Additional review of the hospital’s policy and procedure entitled: “Automatic Stop Orders”, dated 7/1/2024, reads: “ ...C. Hard Stops may be superseded by a provider order to continue for a specified period of time past the timeframes defined in Table 1 ...Table 1 (Hard Stop Medication List) ...(Medication) Acetaminophen (injectable), (Duration) 24 hours.” During an interview with SDAL on 11/5/2025 at 9:00 am, she confirmed that the hospital’s policy and procedure was for the hospital not to allow for Tylenol I.V. to be ordered for any patient beyond 24 hours. During an interview with MD-1 on 11/5/2025 at 11:10 am the physician remembered Patient-301, who had been brought into the hospital by the California Highway Patrol (CHP). During a discussion with MD-1, he said that he did remember ordering the Tylenol I.V. for this patient, however he stated that he did not remember changing the Tylenol order duration from 24 hours to 30 days. MD-1 seemed to believe that hospital’s ordering system must have automatically attached a 30 duration to the Tylenol order. The hospital’s SDAL indicated during an interview that the hospital’s ordering system would have generated a 24-hour stop date. No one from the hospital could explain why Patient-301’s Tylenol order continued beyond the 24 hours which had been predetermined in the Pharmacy’s Stop Order policy and procedure above. Review of Patient-301’s Medication Administration Record (MAR) dated 9/13/2025 at 11:47 pm read: “Adult maximum dose: 4000 mg of acetaminophen (Tylenol) in 24-hour period ...check for administration of other acetaminophen orders including PRNs ...Tenet Hard Stop of 24 hours. Pharmacist must ensure correct (1) Duration and (2) Stop Type (Physician or Hard Stop) before submitting”. Patient 301 was transferred from the Emergency Department to the hospital’s Intensive Care Unit and the receiving physician (MD-2) wrote an Acetaminophen (Tylenol) order on 9/14/2025 at 8:59 am, for this patient to receive 1,000 mg x 2 tablets by mouth every 6 hours routinely. This oral Tylenol had been given concurrently with the I.V. Tylenol which had been written and administered to Patient -301, from the hospital’s Emergency Room. During an interview with MD-2 on 11/4/2025 at Noon, he stated during the interview: ...The standard at this hospital is for ED orders to be discontinued when a patient leaves the ED and goes to another level of care. “I don’t remember looking at the ED orders”, ...We don’t get a flag for the Tylenol ...I would not intentionally order oral (po) if I.V. was ordered and wouldn’t have ordered 4 grams for anyone. If I knew he was already on Tylenol I.V. I wouldn’t have ordered the oral (po). Looking back now I don’t know if I would have done anything differently except for looking at the orders more fastidiously”. During a record review and an interview with the hospital’s Chief Medical Officer (CMO) on 11/10/2025, the CMO stated: the information that is in the memo below are not new practices, and these practices have been in place, this memo was sent with regard to these practices as a reminder to medical staff, as we wanted to ensure that there are more standardized practices. The memo dated 9/23/2025 to the hospital’s medical staff, from the hospital’s CMO read: “Medication Safety Reminder, This is a reminder for the medical staff regarding medication orders and error prevention in all care areas. Key Safety Points: 1) All ordered medications should be discontinued upon transfer to a different level of service and new orders written. This applies to movement of patients from the ED to inpatient or observation units, as well as patients transferred between levels of service in-house (ICU and OR). 2) Medications ordered in the ED must have stop parameters. 3) Medication reconciliation is the responsibility of the admitting physician and should be completed for every admission when orders are written. Patient safety depends on strict adherence to these practices. Thank you for your attention and commitment to preventing medication errors”. From 9/14/2025 to 9/15/2025 Patient-301 recieved more than 4,000 mg per day of Tylenol (Acetominphen), which exceeded the drug manufacuter’s limits for possible liver damage.”

“NURSING CARE PLAN CFR(s): 482.23(b)(4) The hospital must ensure that the nursing staff develops, and keeps current, a nursing care plan for each patient that reflects the patient’s goals and the nursing care to be provided to meet the patient’s needs. The nursing care plan may be part of an interdisciplinary care plan. This Standard is not met as evidenced by: 40678 Based on interview, and record review the facility failed to ensure that care plans (guide that helps nurses and healthcare staff know what a patient needs and how to care for them) were initiated in accordance with the facility’s policies and procedures (P&P) when there were no pain care plans initiated for Patient 302 and Patient 400. This failure had the potential to prevent individualized care planning and coordination, placing patients at risk for unmet pain management needs and negative outcomes. Findings: During a review of the facility’s P&P titled, “Interdisciplinary Plan of Care” dated 3/14/2024, indicated, “Purpose: To ensure that care, treatment, and rehabilitation are planned and appropriate to the patient’s needs and severity of illness ... Policy: The RN in partnership with the patient initiates the interdisciplinary plan of care upon admission after initial assessment and reviewed/revised every shift ... The plan is individualized and based upon actual or potential problems, anticipated length of stay, assessed needs, polices, patient care standards ...” During a review of the facility P&P tilted, “Pain Management”, dated 08/16/24, the Pain Management Policy indicated in part, “Procedure Summary/Intent: The intent of this policy is to address the management, assessment, and reassessment of pain. C. Care Planning: 1. A pain management care plan should be initiated for all patients who report pain”. During a review of Patient 302’s medical record which indicated, Patient 302 was admitted to the facility for a surgical procedure “Cervical Two to Thoracic Two Fixation and Fusion with Laminectomy with Right Cervical Five to Cervical Six and Cervical Seven to Thoracic One Facetectomy”. After the surgery was completed and Patient 302 was transferred to medical surgical floor, Patient 302 had an initial assessment at 5:00 p.m. on 11/3/25 and reported a pain level of 8 on a scale of 0 -10 multiple times, the care plan for pain was not initiated until 11/4/25 at 10:38 a.m. ...” During a concurrent interview and record review on 11/5/25, at 4:40 p.m., with the quality peri-op coordinator (QPC), QPC acknowledged and confirmed staff did not follow the facility P&P for initiating Patient 302’s pain care plan. 49405 During a review of the facility’s Policy and Procedure (P&P) tilted, “Pain Management”, dated 08/16/24, the Pain Management Policy indicated in part, “Procedure Summary/Intent: The intent of this policy is to address the management, assessment, and reassessment of pain. C. Care Planning: 1. A pain management care plan should be initiated for all patients who report pain”. During a concurrent interview and record review on 11/03/25, at 3:24 p.m. with Intensive Care Unit Clinical Educator (CE) 1, Patient 400’s care plan dated 11/03/25 was reviewed. The care plan indicated that Patient 400 did not have a pai care plan initiated. CE 1 acknowledged that there was not a pain care plan for Patient 400 and that a care plan for pain should have been developed.”

“SUPERVISION OF CONTRACT STAFF CFR(s): 482.23(b)(6) All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer). This Standard is not met as evidenced by: 49405 Based on observation, interview, and record review, the facility failed to ensure: 1. Vital signs were completed for one of six sample patients (Patient 401), per their the facility’s policy and procedure (P&P) in their Stepdown Unit (an area that require close monitoring and specialized care) / Telemetry Unit (Tele - an area of a hospital who require continuous cardiac monitoring) unit. 2. Pain care plan (nursing process that plans the individual needs of each paitient) was initiated for one of six sample patients (Patient 400), per their P&P. 3. Consent for blood transfusion was completed per facility’s P&P for one of six sample patients (Patient 403). 4. The crash cart (a mobile cart that holds emergency medical equipment, supplies and drugs used in a life-threatening situation) was checked as per P&P in the Intensive Care Unit (ICU - area of the hospital that provides care to patients with life threatening illness or injury). 5. Intravenous (IV) site was labeled with the start date as per P&P for one of three sample patients (Patient 103) in the ICU. 6. Malignant Hyperthermia cart (emergency medications and supplies used for treating malignant hyperthermia-a rare, life-threatening condition) checks were conducted daily in the ICU. 7. Levophed (powerful medication primarily used in emergency and critical care settings to raise and maintain blood pressure in adult patients experiencing severe, acute hypotensive states) medication titration drip was performed correctly for one of three sample patients (Patient 101). 8. Precedex (a medication used as a sedative) medication drip titration was performed correctly, and RASS scores (a scoring system used to measure a patients level of alertness) were completed for one of three sample patients (Patient 101). 9. Propofol (a medication used as a sedative) medication drip titration was performed correctly, and RASS scores were completed for one of three sample patients (Patient 101). 10. Patient medication assessment was completed as per P&P for one of three sample patients (Patient 103). 11. A laryngoscope (a medical tool used to guide a breathing tube through the vocal cords into the throat for mechanical breathing) handle was not expired in the Labor and Delivery (L&D). 12. Pre- and post-pain assessments were conducted per P&P for one of nine sampled patients (Patient 204). 13. Safe administration of medications, as Tylenol was not administered in accordance with P&P by two Registered Nurses (RNs) for one of four sampled patients (Patient 301). 14. Pain Management P&P was followed for two of four sample patients (Patient 302 and 303). These failures resulted in a Tylenol overdose for one patient (Patient 301), causing serious harm, and had the potential to compromise the health and safety of other patients by depriving them of safe and appropriate nursing care and services. This placed patients at risk of injury, harm, and even death, thereby jeopardizing the overall quality of patient care. Findings: 1. During concurrent interview and record review on 11/04/25 at 4:15 p.m. with Intensive Care Unit Clinical Educator (CE) 2, Patient 401’s “Vital Sign Assessment” flow sheet was reviewed. The flow sheet indicated that vital signs were not completed between 10/30/25 at 2:25 p.m. through 10/31/25 at 11:12 a.m., approximately 20 hours of no documentation of vital signs. CE2 stated that patient 401 was admitted to the step-down unit in the facility and was to have vital signs completed a minimum of every 4 hours and acknowledged that Patient 401 did not have vital signs documented per facility protocol. During review of facility P&P titled, “Cerner Documentation Checklist for Inpatient Units”, no date noted, the Checklist indicated, Frequent Assessment - Vital Signs for the step-down unit are to be completed every four hours. 2. During a concurrent interview and record review on 11/03/25 at 3:30 p.m. with CE 2, Patient 400’s “History and Physical” (H&P) dated 10/31/25 was reviewed. The H&P indicated Patient 400 was admitted for right fracture of femoral neck (broken right leg) on 10/31/25. CE 2 stated that a care plan that was individualized for pain should have been completed on admission to facility. During a concurrent interview and record review on 11/03/25 at 3:35 p.m. with CE 2, Patient 400’s “Care Plan” was reviewed. The care plan indicated that an individualized care plan that includes pain was not completed on admission. CE 2 stated that a pain care plan should have been completed on admission per P&P and acknowledged that it was not done. During a concurrent interview and record review on 11/03/25 at 3:40 p.m. with CE 2, Patient 400’s “Physician Orders” were reviewed. The orders included medications specific for pain including but not limited to, acetaminophen (Tylenol - pain medication) 650 mg (dosage) every four hours PRN (as needed) for pain, mild, dated 10/31/25 at 8:09 a.m. CE 2 acknowledged that Patient 400 had orders for pain medications to be given on admission to the facility. During a review of the facility Policy and Procedure (P&P) tilted, “Pain Management”, dated 08/16/24, the Pain Management Policy indicated in part, “Procedure Summary/Intent: The intent of this policy is to address the management, assessment, and reassessment of pain. C. Care Planning: 1. A pain management care plan should be initiated for all patients who report pain.” During a review of P&P titled, “ Interdisciplinary Plan of Care”, dated 03/2024, indicated, “ PURPOSE: To ensure that care, treatment and rehabilitation are planned and appropriate to the patient’s needs and severity of illness. POLICY: B. the RN in partnership with the patient initiates the interdisciplinary plan of care (which includes discharge planning issues) upon admission after initial assessment and reviewed/revised every shift. E. The plan is individualized and based upon actual or potential problems, anticipated length of stay, assessed needs, policies, patient care standards, cultural issues, available resources and will be consistent with other therapies and / or disciplines”. 3. During a concurrent interview and record review on 11/05/25 at 3:00 p.m. with CE 2, Patient 403’s “H&P” was reviewed. H&P indicated that Patient 403 was admitted to the facility on 10/31/25 with a diagnosis of right upper lobe lung cancer for surgical evaluation. During a concurrent interview and record review on 11/05/25 at 3:05 p.m. with CE 2, Patient 403’s “Transfusion Information and Consent Paul Gann Blood Safety Act”, dated 11/04/25, indicated that the date and time the physician signed the informed consent was not completed. CE 2 stated that this should be complete and acknowledged that it was not done. During a review of facility’s P&P titled “Consent and Informed Consent - California”, dated 05/2025, indicated, “ E. Treatment / Procedures That Require an Informed Consent: 2. Special requirements: a. States may individually identify procedures that have additional consent requirements by law ... iii. Blood transfusion ... F. Documentation: 2. Consent to Surgery or Special Procedure Form: ... vi. Ensure where signature is applied that is is accompanied with a date and time.” 35399 4. During a concurrent observation of the CVICU crash cart (a mobile cart with emergency resuscitation equipment and medications, for quick access in a medical emergency and routinely checked for readiness) and interview with the medical surgical supervisor (MSS) on 11/3/25 at 11:43 a.m., the crash cart checklist was reviewed. The checklists for July and September 2025 showed that the cart was not checked daily as required. MSS acknowledged and confirmed that the checklist contained blank rows, indicating the cart had not been checked on those dates. 5. A review of the facility P&P titled “Intravenous Therapy, Peripheral Site Maintenance”, dated 5/5/25, in the Infection Control part of the policy indicated “Label IV site.” During a concurrent observation of Patient 103’s left arm and interview with the MSS on 11/3/25 at 11:48 a.m., the patient’s intravenous IV (intravenous - to give fluid through a vein) access site was observed without a label indicating the date the IV site was started. The MSS acknowledged the observation and confirmed the patient’s IV site was not labeled. The MSS stated “I agree with you the IV site does not have a label with the date it was started”. 6. During an observation of the malignant hyperthermia (MH) tackle box (a box that holds the emergency supplies and medications needed to treat a patient experiencing a malignant hyperthermia crisis) in the ICU & CVICU and interview with the ICU charge nurse (ICUCN) on 11/5/25 at 4:08 p.m., the ICUCN reported the nursing staff is responsible to check the malignant hyperthermia tackle box daily to ensure the contents inside the box are ready for use during an emergency. Upon review of the MH check list, it was noticed that the box was not checked daily in September and October 2025. The checklist was missing several dates, indicating that the MH box was not checked on those days. The ICUCN acknowledged and confirmed that daily checks had not been performed. 7. During a concurrent review of Patient 101’s physician’s order for Levophed (a medication used to treat critically low blood pressure in serious, short-term medical situations such as shock or cardiac arrest), medication titration drip, electronic medication administration record (e-MAR), vital signs flowsheet, and interview with the Medical Surgical Supervisor (MSS) on 11/4/25 at 4:20 p.m., the order read: “Initial rate 2 mcg/minute (micrograms per minute, a very small unit used to measure medication). Titrate rate 2 mcg/min every 5 minutes (titration means gradually adjusting the dose based on the patient’s condition). For a goal mean arterial pressure (MAP) greater than or equal to 60 (MAP is the average pressure in the arteries during one heartbeat). Maximum dose 30 mcg/min.” The e-MAR indicated Levophed medication drip was started on 10/28/25 at 11:41 a.m., at 2mcg/min for MAP of 56. At 12:00 p.m., medication drip was increased to 4 mcg/min for MAP 55. At 12:16 p.m., medication drip was increased to 6 mcg/min for MAP 57. At 12:30 p.m., medication drip remained at 6 mcg/min for MAP 73. On 11/4/25 at 4:20 p.m., the MSS acknowledged and confirmed that the Levophed physician’s medication titration order was not followed. The MSS stated “I agree with you; the medication drip was not titrated every 5 minutes to reach the goal MAP of 60 or greater. 8. During a concurrent review of Patient 101’s physician’s order for Precedex (powerful sedative and analgesic medication primarily used in hospital settings for sedation in the ICU) medication drip, electronic medication administration record (e-MAR), RASS score flowsheet and interview with the MSS on 11/4/25 at 4:39 p.m., the order read “Start at 0.2 mcg/kg/hr. Titrate by 0.1 mcg/kg/hr., every 1 minute. For goal RASS 0 to - (negative). Maximum dose 1.5 mcg/kg/hr. sedation. The e-MAR indicated Precedex medication drip started on 11/1/25 at 1:00 p.m., at 1.3 mcg/kg/hr. At 1:15 p.m., the medication drip was increased to 1.4 mcg/kg/hr. The Richmond Agitation-Sedation Scale (RASS- is a 10-point scale used to assess a patient’s level of agitation or sedation, ranging from +4 (combative) to -5 (unarousable) score flowsheet indicated there was no RASS score documentation upon Precedex medication initiation. The first RASS score documentation was on 11/4/25 at 12:56 p.m., which was a zero, then at 1:57 p.m., the RASS score was a +2. On 11/4/25 at 4:39 p.m., the MSS acknowledged and confirmed that the physician’s Precedex medication order was not followed as prescribed. The MSS stated “The medication was started at 1.3 mcg/kg/hr., instead of 0.2 mcg/kg/hr., this was wrong.” 9. During a concurrent review of Patient 101’s physician’s order for Propofol (a strong medication used for sedation in adults undergoing medical procedures in the Intensive Care Unit), medication drip, e-MAR, Richmond Agitation-Sedation Scale (RASS) score flowsheet, and interview with the Medical Surgical Supervisor (MSS) on 11/4/25 at 4:38 p.m., the order read: “Initial dose: 30 mcg/kg/minute (micrograms per kilogram per minute). Titration dose: 5 mcg/kg/min (titration means gradually adjusting the dose). Titration interval: every 5 minutes. RASS score -4 to -5 (RASS is a scale used to measure sedation levels). Maximum dose: 65 mcg/kg/min.” The e-MAR indicated Propofol medication drip started on 10/26/25 at 5:25 p.m., at 30 mcg/kg/min. At 5:40 p.m., the medication was increased to 35 mcg/kg/min. At 5:50 p.m., the medication was increased to 40 mcg/kg/min. At 6:00 p.m., the medication was increased to 45 mcg/kg/min. The RASS score flowsheet indicated there was no RASS score documentation upon Propofol medication initiation. The first RASS score documentation was on 10/26/25 at 7:45 p.m., which was a +4. On 11/4/25 at 4:38 p.m., the MSS confirmed the Propofol medication drip was not titrated every 5 minutes as prescribed and there was no RASS score assessment prior or at the time the medication was initiated. 10. A review of the facility P&P titled “Pain Management”, dated 8/3/24, indicates that “A Comprehensive pain assessment should include, to the extent relevant, intensity, site(s), quality, radiation, and onset.” During a concurrent review of Patient 103’s medical record and interview with the MSS on 11/4/25 at 12:08 p.m., the record indicated patient was a 59-year-old gentleman with stage four neuroendocrine carcinoma (endocrine cancer) with chemotherapy who presented on 10/24/25 with hemorrhagic shock and now has acute hyponatremia which was being monitored closely in the ICU. The Pain Assessment flowsheet indicated patient was assessed for pain on 11/2/25 at 11:09 p.m., and on 11/3/25 at 4:52 p.m. However, the pain assessments were incomplete. The MSS confirmed the pain assessments do not contain documentation of all the elements to be assessed during a pain assessment as per their policy and procedure. 39520 11. During a review of the facility’s policy and procedure titled, “Supply Chain expired Product Policy” dated 4/06/23, indicated in part ... “To implement a uniform procedure for the management of expired product ...Definitions: 1. Expired Product-Product whose use by date has passed ...Supply chain operations: 1. All products will be removed from storage prior to expire/use by date and taken to supply Chain leadership for final dispositioning ...” During a concurrent observation and interview on 11/3/25 at 11:26 a.m., with the RN 8, during a tour of the labor and delivery unit, an epidural cart was observed. In a drawer, a laryngoscope(medical device used to look inside the throat) handle, in a single use peel pack, had an expiration date of 10/1/2025. RN 8 acknowledged the laryngoscope handle had expired and should be replaced. 12. During a concurrent interview and record review, on 11/6/25, at 9:56 a.m. with the clinical educator (CE), Patient 204’s medical record was reviewed. Patient 204’s medical record indicated Patient 204 was having pain in the abdomen at 8:15 p.m. on 11/3/25. Patient 204 was given Tylenol extra strength 1000 mg (medication used for pain relief and fever), 2 tablets by mouth and Ibuprofen 600 mg (medication to treat pain, fever, and inflammation), 1 tablet by mouth, at 8:57 p.m. Further review of the medical record had no documentation of a pain assessment before or after the administration of Tylenol and Ibuprofen. CE acknowledged there was no pain assessment documented before or after the administration of Tylenol and Ibuprofen and there should have been. Patient 204 was given another dose of Tylenol extra strength 1000 mg, 2 tablets by mouth and Ibuprofen 600 mg, 1 tablet by mouth, at 5:52 a.m. CE acknowledged there was no pain assessment documented before or after the second administration of Tylenol and Ibuprofen and there should have been. During a concurrent interview and record review, on 11/6/25, at 10:06 a.m. with the clinical educator (CE), Patient 204’s medical record was reviewed. Patient 204’s medical record indicated Patient 204 was having moderate pain, rating a 5/10, at 6:29 a.m. Patient 204 was given Tylenol extra strength 1000 mg, 2 tablets by mouth, and Ibuprofen 600 mg, 1 tablet by mouth, at 6:29 a.m. Further review of the medical record had no documentation of a pain reassessment after the administration of Tylenol and Ibuprofen. CE acknowledged there was no pain reassessment documented after the administration of Tylenol and Ibuprofen and there should have been. During a review of the facility’s policy and procedure titled, “Pain Management” dated 8/16/24, indicated in part ... “The intent of this policy is to address the management, assessment and reassessment of pain ...A. Procedure: 2. Comprehensive Pain Assessment: iii as needed (PRN) when a patient reports new or significant change in pain ...3. Pain Reassessment: a. A pain reassessment shall be performed within one hour after pain intervention ...ii. Measure pain level using pain numeric scale ...” 40678 13. During a review of the facility’s P&P titled, “Medication Administration,” dated 12/13/2024, indicated, “It is the policy of {name of facility} Nursing Division to ensure that licensed nurses follow accepted standards of practice in the administration of medications to patients... prior to administration verify the medication for route, dose and frequency... the prescriber should be contacted for further clarification... the review consists of drug appropriateness, therapeutic duplication... other contraindications, variation from hospital criteria for use and other relevant medication-related issues or concerns... all areas of concern, issues or questions are clarified with the individual prescriber before the medication are dispensed/administered... the medication will be given at the right time...” During a review of Patient 301’s medical record, it indicated a 69-year-old male admitted to the Emergency Department (ED) on 9/13/25, secondary to blunt trauma (injury to the body caused by a forceful impact) from a motor vehicle accident (MVA). Patient 301 had multiple fractures of the ribs, cervical spine, and sternum (long bone in the middle of the chest). In the ED on 9/13/25 at 11:47 p.m., the ED physician orders included Tylenol 1000 mg intravenous (IV - via needle to the vein) every 6 hours. On 9/14/25 at 8:59 a.m., Patient 301 was seen by the Trauma Medical Doctor and ordered Tylenol 1000 mg every 6 hours, 2 tabs PO (by mouth). On 9/14/25, from the ED, Patient 301 was transferred to the Step-Down Unit (unit which provides intermediate care between the ICU and general medical-surgical floor). On 9/14/25 at 12:09 a.m., 1000 mg IV was administered in the ED by a registered nurse. During a concurrent interview and record review, on 11/4/25, at 9:35 a.m. with RN 1 and the manager accreditation and regulatory compliance (MARC), Patient 301’s medical record was reviewed, RN 1 verbalized, I remember Patient 301 and that he had multiple rib fractures and my primary concern was pain management and looking out for pneumothorax. I cared for Patient 301 on 9/14/25 and the patient was already receiving IV Tylenol. The oral Tylenol was a new order. Registered nurse (RN 1) administered Tylenol to Patient 301: On 9/14/25 at 6:44 a.m. 1000 mg IV in the Step-Down Unit (SDU) On 9/14/25 at 1:29 p.m. 1000 mg po in the SDU On 9/14/25 at 3:15 p.m. 1000 mg IV in the SDU RN 1 and MARC acknowledged and confirmed facility P&P was not followed. During a concurrent interview and record review on 11/4/25 at 4:44 p.m. with RN 2 and the Chief Nursing Officer (CNO), Patient 301’s medical record was reviewed. RN 2 stated, “I remember Patient 301 had a scheduled Tylenol order and came in for a motor vehicle accident, so I think I was focused on pain management. The appropriate time that I was supposed to administer the Tylenol was not followed. I don’t know why I would have given the medications early, but I did. I don’t remember if I looked to see if the dose was going to be over the maximum dose, but I know it did now.” RN 2 administered the following Tylenol doses to Patient 301: On 9/14/25 at 10:00 p.m. 1000 mg IV and 1000 mg po administered simultaneously (same time) in SDU. On 9/14/25 at 11:24 p.m. 1000 mg IV and 1000 mg po administered simultaneously in SDU. On 9/15/25 at 6:25 a.m. 1000 mg IV and 1000 mg po were administered simultaneously in SDU. RN 2 and CNO acknowledged and confirmed the facility P&P was not followed. Further review of Patient 301’s record indicated, on 9/15/25, Patient 301 was transferred from the SDU to the Medical-Surgical Unit (MS), and another registered nurse noticed the patient had two sets of Tylenol orders-one for IV and the other PO. On 9/15/25 at 11:59 a.m., 1,000 mg po was administered in the MS unit by a registered nurse. Review of the Physician Discharge Summary Notes dated 9/19/25 indicated in part, “after the patient underwent a successful resuscitation and taken to the ICU, the patient’s laboratory evaluation showed acute anemia (low red blood cell count, thrombocytopenia (low blood platelets leading to bleeding), and the liver function test was consistent with liver failure. Patient received blood transfusion, but with bowel ischemia (not enough blood flow to the intestines), and underwent an emergent surgical procedure secondary to venous thrombosis (blood clot in vein). Patient never recovered fully post-surgery and expired on 9/19/25.” 14. During a review of the facility’s policy and procedure titled, “Pain Management” dated 8/16/24, indicated in part... “The intent of this policy is to address the management, assessment and reassessment of pain... A. Procedure: 2. Comprehensive Pain Assessment: iii as needed (PRN) when a patient reports new or significant change in pain... 3. Pain Reassessment: a. A pain reassessment shall be performed within one hour after pain intervention...ii. Measure pain level using pain numeric scale... 5. Based on patient self-report and ongoing assessment findings, the plan and treatment of the patient’s pain will be modified by members of the patient’s care team ... 6. Consider nonpharmacologic pain management interventions ... can enhance the patient’s sense of control and add to the effectiveness of the pharmacologic interventions ...” During a concurrent interview and record review, on 11/5/25, at 10:40 a.m. with RN 9, Patient 302’s medical record indicated, on 11/4/25 at 7:42 Patient 302 reported having pain as an 8 (on a pain scale of 0 to 10, with 0 being no pain and 10 being the worst pain ever experienced) and on 11/5/25 at 0329 reported pain as an 8 again. RN 9 was unable to find documentation that Patient 302 received any interventions for pain including that the patient received any pain medication, although patient had pain medications ordered. RN 9 acknowledged and confirmed staff did not follow P&P. During a concurrent interview and record review, on 11/5/25, at 5:28 p.m. with RN 9, Patient 303’s medical record indicated, on 11/3/25 at 11:06 a.m. patient received Dilaudid (medication for moderate to severe pain) 0.5mg IV push for reported pain of 6 and was not reassessed for pain until 11/3/25 at 3:50 p.m., RN 9 acknowledged and confirmed staff did not follow facility P&P.”

“ADMINISTRATION OF DRUGS CFR(s): 482.23(c)(1), (c)(1)(i) & (c)(2) (1) Drugs and biologicals must be prepared and administered in accordance with Federal and State laws, the orders of the practitioner or practitioners responsible for the patient’s care as specified under §482.12(c), and accepted standards of practice. (i) Drugs and biologicals may be prepared and administered on the orders of other practitioners not specified under §482.12(c) only if such practitioners are acting in accordance with State law, including scope of practice laws, hospital policies, and medical staff bylaws, rules, and regulations. (2) All drugs and biologicals must be administered by, or under supervision of, nursing or other personnel in accordance with Federal and State laws and regulations, including applicable licensing requirements, and in accordance with the approved medical staff policies and procedures. This Standard is not met as evidenced by: 50132 Based on interview and record revies, the facility failed to ensure that a medication order for one of 35 sampled patients (Patient 505) was written in accordance with state and federal laws, professional standards of practice, and hospital policy, when a Morphine order (opioid medicine for moderate to severe pain) was approved without safety parameters or a maximum dosage. This failure had the potential to result in an accidental overdose, adverse drug-related outcome, or death. Findings: During a concurrent interview and record review on 11/5/25 at 11:24 am, with Clinical Educator (CE), Patient 505’s “Pharmacy Medication Orders”, dated 11/4/2025 was reviewed. The “Pharmacy Medication Orders” indicated a medication order for “Morphine (an opioid medication intended to treat pain) 2mg=1ml, Injection (a medical procedure that involves using a needle and syringe to administer medication), IV Push (rapid administration of medication directly into a patients veins), Q (every) 15 min [minute] -int [intervals] PRN (as needed) For: Pain Severe, Start date 11/4/25 3:26 PM End-state Date/Time: 12/4/2025 15:25”. CE stated that the order read as the medication could be administered every 15 minutes for severe pain. When asked what severe pain would be considered CE stated anything above a 7 [on a scale of 0-10]. When asked when a nurse caring for the patient would stop administering the medication if the order is for every 15-minute intervals, CE stated “I guess when he was asleep. He wouldn’t complain of pain then.” CE stated that this order is the part of the doctor’s order set and “that’s how he always orders it.” During a concurrent interview and record review on 11/5/25 at 3:45 pm, with Clinical Informatics Specialty (CIS), Clinical Pharmacist Supervisor (CPS), and the Systems Director of Accreditation & Licensing (SDAL), Patient 505’s “Pharmacy Medication Orders”, dated 11/4/2025 was reviewed. The “Pharmacy Medication Orders” for “Morphine (an opioid medication intended to treat pain) 2mg=1ml, Injection (a medical procedure that involves using a needle and syringe to administer medication), IV Push (rapid administration of medication directly into a patients vein), Q (every) 15 min [minute] -int [intervals] PRN (as needed) For: Pain Severe, Start date 11/4/25 3:26 PM End-state Date/Time: 12/4/2025 15:25” was reviewed. CPS stated that the order was missing parameters and there was no maximum dosage indicated for the narcotic. CPS stated that this order could be very dangerous. When informed that this order was part of the MD’s order set, CPS stated that there was no way to monitor a doctor’s order set. CPS stated that it is the Pharmacy responsible to verify all drug orders. CIS stated that the nurse could interrupt the order as to give the patient Morphine every 15 min around the clock if they had pain. CIS stated that a nurse could medicate the patient enough to decrease their respiratory drive. During a review of the facility’s policy and procure titled, “Medication Prescribing Verification and Administration”, dated 4/3/2025, indicates in part “B. Medication Orders in conflict with Standard of Practice 1. If the pharmacist, in the course of following their duties or responsibility finds the use of a medication prescribed by a medical staff physician inconsistent with the approved standard of practice, he/she is required to intervene. C. Incomplete Orders requiring additional information re: monitoring parameters: 1. Complex orders, orders for medication requiring patient monitoring for assessment. Or orders which need additional information to ensure safe administration, must provide additional information re: monitoring parameters, etc.””

“PHARMACY ADMINISTRATION CFR(s): 482.25(a) [§482.25 Condition of Participation: Pharmaceutical Services .....The medical staff is responsible for developing policies and procedures that minimize drug errors. This function may be delegated to the hospital’s organized pharmaceutical service.] §482.25(a) Standard: Pharmacy Management and Administration The pharmacy or drug storage area must be administered in accordance with accepted professional principles. This Standard is not met as evidenced by: 13095 Based on review of the hospital’s policies and procedures, interview with hospital staff, and medical record review, the hospital’s Pharmacists (three), failed to ensure that two Tylenol orders for Patient-301 and one Morphine order for Patient-505, were reviewed and approved, in accordance with the hospital’s policies and procedures. This resulted in the hospital having a medication error with this patient which could have potentially resulted in harm to these patients. Findings: In September of 2025, a 69-year-old patient who had been brought into the hospital by California Highway Patrol after a head-on freeway collision on 9/13/2025 had been admitted into the hospital’s Emergency Room. The Emergency Room (ED) physician who saw Patient-301, on 9/13/2025 at 11:47 pm had written an order for Tylenol 1,000 milligrams (mg) every 6 hours via Intravenous (IV) for 30 days. Review of the hospital’s policy and procedure entitled: “Automatic Stop Orders”, dated 7/1/2024, reads: “ ...C. Hard Stops may be superseded by a provider order to continue for a specified period of time past the timeframes defined in Table 1 ...Table 1 (Hard Stop Medication List) ...(Medication) Acetaminophen (injectable), (Duration) 24 hours.” During an interview with SDAL on 11/5/2025 at 9:00 am, she confirmed that the hospital’s policy and procedure was for the hospital not to allow for Tylenol I.V. to be ordered for any patient beyond 24 hours. A. Review of the clinical record for Patient-301 on 11/4/2025 at 11:40 am revealed that this Tylenol order had been verified by a Telehealth Pharmacist [Pharmacist 1] (which was in Northern California) on 9/13/2025 at 11:47 pm, contrary to the hospital’s policy and procedure above. Further review of the hospital’s policies and procedures entitled: “Medication Prescribing Verification and Administration”, dated 4/3/2025, read: “ ...B. Medication orders in conflict with standards of practices. 1. If the pharmacist, in the course of following their duties or responsibility finds the use of a medication prescribed by a medical staff physician inconsistent with the approved standard of practice, he/she is required to intervene. 2. Therapy conflicts ...The pharmacist shall contact the physician directly to discuss the therapeutic issue(s) and contact the primary care nurse regarding the possible delay in therapy. 3. The pharmacist will record and document such clinical interventions ... 2. Medication order entries and processing ...g. This review process is to verify completeness and accuracy of the order entry process ...h. Orders that require clarification should be addressed ASAP, any unresolved problem orders shall have documentation of attempted resolution ...”. Review of the hospital’s policy and procedure entitled: “Medication Administration”, dated: 12/13/2024, read: “ ...iii. All areas of concern, issues or questions (including unapproved abbreviations) are clarified with the individual prescriber before the medication (s) is (are) dispensed ...”. On 11/6/2025 at 7:10 am during an interview with Pharmacist 1, Pharmacist 1 was asked several questions. Question #1, Did you verify the Tylenol order above? Response: “yes I did”; question #2, Did you receive any alerts on your computer while you were working on this order?, response: “no”; question # 3, Did you modify this order (before you approved it)?, “no”; question # 4, were you aware that the Tylenol (Acetaminophen) had been ordered for 30 days?, response: “yes”; question # 5, what do you know about Tylenol I.V. durations? Response: “on September 19th, 2025, the Pharmacy received an update (regarding Tylenol I.V. use for only 24 hours), however there was nothing (no guidance was) in place (that we were aware of) prior to this date”. Based on the date of the medication error event above, the guidance which was sent to Pharmacist 1, had not been provided until 3 days after the medication error event. B. Review of the clinical record for Patient-301 on 11/4/2025 at 11:40 am revealed that Patient-301’s Trauma physician had ordered oral Tylenol 1,000 mg (2 tablets) to be given every 6 hours and to start on 09/14/2025 at noon. The first dose of oral Tylenol was given to Patient-301 at 11:59 am. Based on the oral Tylenol Patient-301 could receive up to 3,000 mg of oral Tylenol and up to 3,000 mg of Tylenol I.V. per day (for a total of 6,000 mg per day). The oral Tylenol had been given along with Patient-301’s I.V. Tylenol, resulted in this patient having elevated Tylenol levels. On 9/14/2025 at 9:22 am, the hospital’s Pharmacist # 2 verified/approved the oral Tylenol order above without modifying the order, seeking clarification from the patient’s physician, contrary to the Tylenol manufacturer’s information below. The following information below, is a part of the drug manufacturer of Tylenol’s package insert: “Acetaminophen Label Liver Warnings, All TYLENOL® product labels have the following liver warnings: Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take: “ more than 4,000 mg of acetaminophen in 24 hours “ with other drugs containing acetaminophen “ 3 or more alcoholic drinks every day while using this product.” Despite the information above from the drug’s manufacturer, this patient appeared to receive as much as 6,000 mg of Tylenol in a 24-hour period for multiple days. Review of the hospital’s policy and procedure, entitled: “Medication prescribing verification and administration”, dated 4/3/2025, read: “1. If the pharmacist, in the course of following their duties or responsibility finds the use of a medication prescribed by a medical staff physician inconsistent with the approved standard of practice, he/she is required to intervene. 2. Therapy conflicts/duplication: The pharmacist shall contact the physician directly to discuss the therapeutic issue(s) and contact the primary care nurse regarding the possible delay in therapy. 3. The pharmacist will record and document such clinical interventions.” C. On 11/5/25 at 2: 50 pm a medication order for Patient-505, was reviewed with a Nurse Surveyor. The medication order read: “Morphine (an opioid medication intended to treat pain) 2mg=1ml, Injection (a medical procedure that involves using a needle and syringe to administer medication), IV Push (rapid administration of medication directly into a patients veins), Q (every) 15 min [minute] -int [intervals] PRN (as needed) For: Pain Severe, Start date 11/4/25 3:26 PM End-state Date/Time: 12/4/2025 15:25”. When the Nurse Surveyor asked a nurse (who had been caring for Patient-505), when would you stop administering this medication if it has been ordered to be given every 15-minute, the Nurse caring for the patient stated: “I guess when he was asleep. He wouldn’t complain of pain then.” The nurse further elaborated stating: “that’s how he always orders it.” During a concurrent interview and additional record review on 11/5/25 at 3:45 pm with following members of the hospital: Clinical Informatics Specialty (CIS), Clinical Pharmacist Supervisor (CPS), and the Systems Director of Accreditation & Licensing (SDAL), Patient 505’s “Pharmacy Medication Orders”, dated 11/4/2025 was reviewed. The hospital’s CPS stated that the order was missing parameters and there was no maximum dosage indicated for this narcotic. CPS stated that this order could be very dangerous. CPS stated that it is the Pharmacy responsible to verify all drug orders. CIS stated that the nurse could interrupt the order as to give the patient Morphine every 15 min around the clock if they had pain. CIS stated that a nurse could have medicated Patient-505, enough to decrease their respiratory drive. During a review of the facility’s policy and procure titled, “Medication Prescribing Verification and Administration”, dated 4/3/2025, indicates in part “B. Medication Orders in conflict with Standard of Practice 1. If the pharmacist, in the course of following their duties or responsibility finds the use of a medication prescribed by a medical staff physician inconsistent with the approved standard of practice, he/she is required to intervene. C. Incomplete Orders requiring additional information re: monitoring parameters: 1. Complex orders, orders for medication requiring patient monitoring for assessment. Or orders which need additional information to ensure safe administration, must provide additional information re: monitoring parameters, etc.” The hospital’s Pharmacist also failed to follow these sections of the hospital’s policies and procedures above. “The pharmacist will record and document such clinical interventions ... 2. Medication order entries and processing ...g. This review process is to verify completeness and accuracy of the order entry process ...h. Orders that require clarification should be addressed ASAP, any unresolved problem orders shall have documentation of attempted resolution ...”. Review of the medical record for Patient-505, revealed that the hospital’s Pharmacist who had verified/approved this order, had not intervened, documented, or modified this physician’s order for patient safety, especially in light of the medication nurse who had been taking care of this patient and the hospital’s policies and procedures outlined above.”

“PHARMACIST SUPERVISION OF SERVICES CFR(s): 482.25(b)(1) §482.25(b)(1) - All compounding, packaging, and dispensing of drugs and biologicals must be under the supervision of a pharmacist and performed consistent with State and Federal laws. This Standard is not met as evidenced by: 35399 Based on observation and interview, the facility failed to ensure pharmacy staff correctly dispensed to the ICU an unsampled patient’s Thiamine (vitamin B1, a medication that helps the body make energy and is vital for heart, brain, and muscle function, especially in critically ill patients), which required protection from light. This failure had the potential to reduce the medication’s effectiveness, which could negatively impact the patient’s treatment. Findings: During an observation on 11/3/25 at 11:59 a.m. in the ICU medication room, a 100 milliliter bag of Thiamine was observed on the counter without light protection, despite a label on the back of the bag stating “Protect from light.” During an interview conducted at the same time with the Medication Safety Specialist (MSS), the MSS confirmed the medication was not being protected from light and stated, “No, the medication is not being protected from light. Normally the medication would have a dark cover to protect the medication from light. But this medication does not have a cover.””

“SECURE STORAGE CFR(s): 482.25(b)(2)(i) §482.25(b)(2)(i) - All drugs and biologicals must be kept in a secure area, and locked when appropriate. This Standard is not met as evidenced by: 13095 Based on observation, interview and record review the facility failed to ensure that patients’ own medications remained secure (as the hospital outlined in reference to the DEA’s Pharmacist Drug Handbook), without the hospital taking possession of these drugs and preventing a possible diversion opportunity, even after a patient had been discharged, and the patient’s medications were being sent for destruction, by the hospital. This facility failure had the potential to result in controlled and non-controlled medications being diverted or lost by security. Findings: During a review of the facility’s policy and procedure (P&P) titled, “Patient Own Medication Storage Use and Destruction”, dated 9/3/2025, read: “ ...C. All medications will be considered “patient belongings” whether a controlled substance or not. The POM (patient’s own medications) will be handled in similar manner. Patient Own Medications will be stored in a secure safe as described in this policy, while non-medication belongings (purse, clothing, pillow, etc.) will be stored in the separate cabinet ...” The hospital’s policy for Patient Own Medications (POM) reads: “viii. A secure place IN EACH UNIT shall be designated for the storage of POM. The area should be locked and keys kept in Omnicell for tracking ...”. This was contrary to the original discussion of how POMs, would all be kept in the “House Supervisor’s Office only”. During a concurrent interview and record review, on 11/10/25, at 10:45 a.m., with the pharmacy administrative staff and the house supervisor verbalized that the facility will no longer take possession of any patient’s own medications and store them in the pharmacy. The pharmacy administrative staff and the house supervisor acknowledged and confirmed that the policy still outlines that the facility is taking possession of the patient’s own medications, and that the facility is taking responsibility for these medications (by storing these medications in the house supervisor’s office), which is contrary to what the hospital’s consultant had told the hospital. The facility P&P also read: “ ...D. If the patient cannot send the medications home, the facility staff shall securely store the medications ... For an alert, cognizant patient and oriented X3 and of sound-mind the nurse and patient shall together identify the name of the medications at the patient’s bedside to record the medications ... If the patient’s own medication is used: “iv. The POM will be placed in a baggy and a hospital label (with bar code) attached. The label will include the usual information including the medication name, strength, instructions, barcode for bedside medication verification, etc ... viii. A secure place in each unit shall be designated for the storage of POM. The area should be locked and keys kept in Omnicell for tracking ... H. Storage of unused medications: 2 ... stored in a locked cabinet separate from the patient’s property and valuables in the House Supervisor office ... 3. The POM medications will be stored by the House Supervisor through a 2 key locking procedure ...” During an interview on 11/6/25, at 11:00 a.m., with systems director of accreditation & licensing (SDAL), SDAL was asked to provide a copy of the regulation which required all patient medications to be stored in the facility’s house supervisor’s office. SDAL provided a section from the DEA’s Pharmacist Manual, which read: “the hospital could secure the CONTROLLED SUBSTANCES with the patient effects in his or her HOSPITAL ROOM (e.g., small safe or secured lock box) ...” The information provided does not instruct the facility to keep CONTROLLED DRUGS in the House Supervisor’s office. The section in the Pharmacist’s Manual above referenced: “21 U.S.C 841 (a). When SDAL was asked to provide a regulation, SDAL provided the regulation above which reads: “ ...Unlawful acts, Except as authorized by this subchapter, it shall be unlawful for any person knowingly or intentionally: 1) to manufacture, distribute, or dispense, or possess with INTENT to manufacture, distribute, or dispense, a controlled substance ...” SDAL was unable to provide any type of explanation for how any of this would keep the facility from storing both controlled and non-controlled medications in the facility’s pharmacy or in a separate safe or lock box in a patient’s room and why the facility had interpreted, the DEA’s Pharmacist’s Manual language, in the manner above. Additional, review of the P&P above read: “The disposition of medications shall be cosigned by two Adventist Health associates and delivered to a US Post office receptacle by Security ....” The facility was unable to explain or ensure that a system had been put in place to ensure that security could not divert the Patient Own Medication (POM) controlled and non-controlled medications from their intended path, in route to the reverse distributor (the reverse distributor, is responsible for destroying these medications, if/once they are received).”

“UNUSABLE DRUGS NOT USED CFR(s): 482.25(b)(3) §482.25(b)(3) - Outdated, mislabeled, or otherwise unusable drugs and biologicals must not be available for patient use This Standard is not met as evidenced by: 40678 Based on observation, interview, and record review the facility failed to label a multi- dose vial per the facility policy and procedure. This failure had the potential for negative patient outcomes including expired medication being administered to patients. Findings: During a review of the facility’s policy and procedure titled, “Drug Distribution - Multi-Dose Containers”, dated 5/8/25, indicated “the purpose of this policy and procedure is to ensure the safe and proper usage of multi-dose containers/vials in the hospital ... It is the responsibility of the individual who dispenses a multi-dose container/vial to initial and date using a permanent marker ... All multi-dose containers ... must be dated and initialed at the time of original puncturing ... A sticker is placed on the vial EXPIRES ON ____... Refrigerated medications in the pharmacy shall have the expiration date entered onto the outside of the vial by the person initially removing the product from the refrigerator ... These containers must be discarded 28 days from this date or sooner if the container so states or the expiration time is less than 28 days...” During a concurrent observation and interview with the stroke coordinator (SC) on 11/3/25 at 11:55 am., in the Day Stay (area where patients are prior to surgery and for recovery from surgery), a regular insulin (medication used to manage blood sugar) multi-dose vial (used more than once and or for multiple patients) was observed with an open date of 11/7/25, which is a future date. Additionally, the expiration date was not entered on the outside of the vial. The SC acknowledged and confirmed that the open date documented is 11/7/25 and today’s date is 11/3/25.”

“STOP-ORDERS FOR DRUGS CFR(s): 482.25(b)(5) §482.25(b)(5) - Drugs and biologicals not specifically prescribed as to time or number of doses must automatically be stopped after a reasonable time that is predetermined by the medical staff. This Standard is not met as evidenced by: 35399 Based on interview and record review the facility failed to ensure the pharmacist verified the injectable Tylenol (temporarily relieve mild to moderate pain and reduce fever) medication orders to adhere to the Automatic Stop Process. The failure place patients at risk of being administered injectable Tylenol medication for more than 24 hours resulting in Tylenol overdose. Findings: A review of the facility P&P titled “Automatic Stop Orders”, dated 5/3/25 indicates “[hospital’s name] will ensure safe administration of medications through the Automatic Stop Process. Medications that should be included, at a minimum, as part of the Automatic Stop Process are included in Table 1. Table 1 (Hard Stop Medication List) indicated Tylenol injectable, the duration was 24 hours.” During an audit of the Table 1 Hard Stop Medication list with the clinical pharmacist supervisor (CPS) on 11/6/25 from 11:15 a.m., to 1:00 p.m., the CPS reported the process is that when a provider orders Tylenol injectable. The pharmacist verifies that the provider has ordered the Tylenol medication for only 24 hours. If the provider orders the injectable Tylenol medication for more than 24 hours, the pharmacist must change the duration of the medication to only 24 hours when the pharmacist verifies the order. This process ensures the patients will only receive injectable Tylenol for 24 hours and decreases the risk of patients receiving Tylenol for a long time. A random audit of eight (8) patients who had orders for Tylenol injectable was conducted to evaluate the facility’s Automatic Stop Process. Four (4) patients out of eight sampled patients had concerns with their Tylenol orders. The following was discovered during the audit process. a) Patient 104 had a provider’s order for routine Tylenol injectable 1000 mg/100 ml intravenous (IV) every 6 hours with start date of 9/5/25 and stop date of 10/4/25. The order was missing the hard stop of 24 hours. The duration area was left blank in the PowerChart system. The CPS confirmed the Tylenol medication duration of 24 hours was missing even after the pharmacist had verified the medication order. The CPS stated “I agree the provider did not input the medication duration of 24 hours. The system defaulted to the 30 days duration time. The pharmacist verified the order and did not correct the duration time from 30 days to 24 hours.” b) Patient 105 had a provider’s order for routine Tylenol injectable 1000 mg/100 ml intravenous (IV) every 6 hours with start date of 9/10/25 and stop date of 10/10/25. The duration time was 30 days. The order was verified by the pharmacist, and the duration time did not change from 30 days to 24 hours. The CPS stated “I agree. The system defaulted to the 30 days duration time. The pharmacist verified the order and did not correct the duration time from 30 days to 24 hours.” c) Patient 106 had a provider’s order for routine Tylenol injectable 1000 mg/100 ml intravenous (IV) every 6 hours with start date of 9/15/25 and stop date of 10/15/25. The duration time was 30 days. The order was verified by the pharmacist, and the duration time did not change from 30 days to 24 hours. The CPS stated “I agree. The system defaulted to the 30 days duration time. The pharmacist verified the order and did not correct the duration time from 30 days to 24 hours.” d) Patient 107 had a provider’s order for routine Tylenol injectable 1000 mg/100 ml intravenous (IV) every 6 hours with start date of 9/7/25 and stop date of 10/7/25. The order was missing the hard stop of 24 hours. The duration area was left blank in the PowerChart system. The CPS confirmed the Tylenol medication duration of 24 hours was missing even after the pharmacist had verified the medication order. The CPS stated “I agree with you again, the provider did not input the medication duration of 24 hours. The system defaulted to the 30 days duration time. The pharmacist verified the order and did not correct the duration time from 30 days to 24 hours.””

“PHARMACY: REPORTING ADVERSE EVENTS CFR(s): 482.25(b)(6) Drug administration errors, adverse drug reactions, and incompatibilities must be immediately reported to the attending physician and, if appropriate, to the hospital’ s quality assessment and performance improvement program. This Standard is not met as evidenced by: 13095 Review of the hospital’s P&T minutes, interview with the hospital’s Pharmacy Administration, and review of the hospital’s Medication error policy and procedures, the hospital failed to ensure that it followed it medication error policies and procedures. This had the potential to prevent the hospital from using medication error data to systematically modify the hospital’s ability to make changes. Findings: Review of the hospital’s policy and procedure on 11/5/2025 at 3:30 pm entitled: “Adverse Drug Reaction and Medication Error Reporting”, dated 5/7/2025, read: “2. Medication error and near miss data will be evaluated for trends to identify areas for improvement.” During an interview with the hospital’s Pharmacy Administration staff on 11/10/2025, the hospital acknowledged that they could not provide evidence that the hospital had been evaluating their near miss data and their medication errors for trends to identify areas for improvement. The same Hospital’s policy and procedure above, entitled: “Adverse Drug Reaction and Medication Error Reporting”, read: “3. The Medical Staff, through its Pharmacy and Therapeutics Committee functions shall review all medication safety events ...”. Review of the hospital’s Pharmacy and Therapeutics Committee minutes from the last 12 months, and interview with the hospital’s Pharmacy Administration on 11/6/2025 at 11:45 am, revealed that the hospital was unable to provide evidence that the hospital’s Medical Staff, through the hospital’s Pharmacy and Therapeutics Committee, was reviewing all of the hospital’s medication errors, as outlined in the hospital’s policy and procedure above. During the interview above with Pharmacy Administration, Pharmacy Administration confirmed that all of the hospital’s medication errors were not being sent to the hospital’s Pharmacy and Therapeutics Committee for review. As outlined in the hospital’s policy and procedure above, “2. Medication error and near miss data will be evaluated for trends to identify areas for improvement ...”. The hospital failed to provide evidence that it was using both Medication errors and near miss data to identify areas for improvement in the hospital. The American Society of Hospital Pharmacist (ASHP), which is a nationally recognized organization stated in their: “Medication Safety Guidelines”: “The outcomes or clinical significance of many medication errors may be minimal, with few or no consequences that adversely affect a patient. In addition, numerous medication errors go unrecognized and are not detected or reported. Tragically, however, some medication errors result in serious patient morbidity or mortality. Thus, medication errors (including close calls) must not be taken lightly, and risk-reduction strategies and systems should be established to prevent or mitigate patient harm from medication errors ...”. This hospital has had two significant medication errors (which may have resulted in patient harm), within a 10-month period. Review of hospital’s: “AHCC Medication Safety Committee minutes (which includes both hospitals in the area data), revealed that the Medication Safety Committee did not have evidence that this Committee had been to be provided, all of the hospital’s medication errors and near misses for their review, as outlined in the hospital’s policy and procedure above, for improvement. The hospital was able to provide colored graphs, which did not add any depth to the hospital’s failure to analyze the hospital’s medication errors and near misses. Interview with the hospital’s Telehealth Pharmacy Director on 11/6/2025 at Noon, revealed that the Telehealth (off-sight Pharmacy), did not have a copy of all of the hospital’s policies and procedures which it provided coverage for in Southern California. An Excel spreadsheet was provided to the surveyors, which the Telehealth Pharmacist was supposed to use, but the Director of Pharmacy for the Telehealth Pharmacy indicated that she did not know when the I.V. Tylenol stop date had been added to this spreadsheet. The Telehealth Director of Pharmacist also stated during the interview that she was not able to review all of the information which had been put into the Southern California hospital’s Excel spreadsheet. One of the hospital’s significant medications which occurred in September of 2025, involved a 69-year-old patient who had been brought into the hospital by California Highway Patrol after a head-on freeway collision on 9/13/2025 and admitted into the hospital’s Emergency Room. The Emergency Room (ED) physician who had attended to this patient, on 9/13/2025 at 11:47 pm had ordered Tylenol 1,000 milligrams (mg) every 6 hours via Intravenous (IV). This Tylenol order had been verified by a Telehealth Pharmacist (which was in Northern California) on 9/13/2025 at 11:47 pm. Interview with the Telehealth Pharmacist on 11/6/2025 at 7:10 am (who verified/approved the I.V. Tylenol for this patient), on 09/13/2025, revealed that this Pharmacist did remember (after reviewing the patient’s medical record), that on 09/13/2025 at 11:51 pm, she had indeed verified this patient’s I.V. Tylenol order. This Pharmacist also revealed during this interview that she was aware that this patient had been put on a 30-day order for I.V. Tylenol. The Pharmacist also indicated that she had not been made aware that the hospital had a policy limiting I.V. Tylenol to 24 hours. She had verified the I.V. Tylenol for, had modified their Tylenol I.V. policy to limit the administration of this medication to 24-hours, as of 9/19/2025, 6 days after this significant medication error. On 9/14/2025 at 8:59 am a different physician (the hospital’s Trauma Physician), ordered Tylenol 1,000 mg (2 tablets) every 6 hours by mouth. This last Tylenol order was verified by the hospital’s on-site Pharmacist on 9/14/2025 at 9:22 am. From 9/14/2025 to 9/15/25 at 11:59 am, this patient received both routes of Tylenol, which resulted in the patient receiving an excessive amount of Tylenol, as this patient received more than 4,000 mg of Tylenol in a 24-hour period. The following information below is a part of the drug manufacturer of Tylenol’s package insert: “Acetaminophen Label Liver Warnings, All TYLENOL® product labels have the following liver warnings: Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take: “ more than 4,000 mg of acetaminophen in 24 hours “ with other drugs containing acetaminophen “ 3 or more alcoholic drinks every day while using this product.””

“FORMULARY SYSTEM CFR(s): 482.25(b)(9) A formulary system must be established by the medical staff to assure quality pharmaceuticals at reasonable costs. This Standard is not met as evidenced by: 13095 Based on review of the hospital’s approved drug formulary, interview with Pharmacy Administration, and review of the hospital’s drug formulary policies and procedures, and review of the hospital’s Pharmacy and Therapeutics (P&T) Committee minutes the hospital failed to implement their policy and procedure. This had the potential make it difficult for the hospital to provide timely administration of drugs (which were on the hospital’s drug formulary), to patient recieving care from the hospital. Findings: The hospital’s Pharmacy was asked to provide a copy of the hospital’s current drug formulary. During an interview with the hospital’s Pharmacy Director (PD) on 11/5/2025 at 5:15 pm, during the interview, the PD was asked to provide a list of formulary drugs which were on the hospital’s drug formulary, but not in stock in the pharmacy. Review of the hospital’s policy and procedure entitled: “Drug Formulary”, dated 9/2025 read: “A. Application of the Formulary System: 3. Only formulary drugs are routinely stocked and available from the pharmacy.” The following day (11/6/2025 at 10:30 am), the PD provided a list of drugs which were on the hospital’s drug formulary but were not stocked in the pharmacy. This list contained 284 different drugs which were on the hospital’s drug formulary but were not currently stocked in the hospital’s pharmacy. The pharmacy also had numerous drugs which were not on the hospital’s drug formulary in stock, as the pharmacy referred to these as (non-formulary medications), which were stored inside multiple drugs in the pharmacy. Further review of the hospital’s drug formulary revealed that Droperidol (Inapsine) was on the hospital’s current drug formulary. Review of the hospital’s Pharmacy and Therapeutics Committee Minutes dated 9/2025, the minutes read: “4. Droperidol- NOT APPROVED- Concerns about safety, consent documentation, etc ....” Droperidol was never removed/ taken off of the hospital’s drug formulary as indicated by the hospital’s P&T Committee on 9/2025. Further review of the hospital’s review of the hospital’s policy and procedure entitled: “Drug Formulary”, dated 9/2025 read: “F. The Formulary: 1. Drugs currently in stock will be reviewed for inclusion in the TCCH formulary. This review will occur Annually.” Interview with the PD on 11/6/2025 at 10:30 am, revealed that the last time that the hospital reviewed it drug formulary, was on 4/15/2024. The last drug formulary review for the hospital occurred approximately 1 year and 7 months ago, well beyond the 12-month annual review outlined in the hospital’s policy and procedure.”

“QUALITY IMPROVEMENT ACTIVITIES CFR(s): 482.21(b)(2)(ii), (c)(1), (c)(3) (b) Program Data (2) [The hospital must use the data collected to - .....] (ii) Identify opportunities for improvement and changes that will lead to improvement. (c) Program Activities (1) The hospital must set priorities for its performance improvement activities that-- (i) Focus on high-risk, high-volume, or problem-prone areas; (ii) Consider the incidence, prevalence, and severity of problems in those areas; and (iii) Affect health outcomes, patient safety, and quality of care. (3) The hospital must take actions aimed at performance improvement and, after implementing those actions, the hospital must measure its success, and track performance to ensure that improvements are sustained. This Standard is not met as evidenced by:”