Saint Luke’s South Hospital

“COMPLIANCE WITH 489.24 CFR(s): 489.20(l) [The provider agrees,] in the case of a hospital as defined in §489.24(b), to comply with §489.24. This Standard is not met as evidenced by: 51768 Based on record review, policy review, and document review the hospital failed to ensure the Emergency Medical Treatment and Labor Act (EMTALA) requirements were met by failing to provide an appropriate medical screening exam (MSE) to determine if an emergency medical condition (EMC) exists for patients who presented to the emergency department (ED) and failed to provided stabilizing treatment for an EMC. Failure to provide an appropriate MSE and stabilizing treatment places patient at risk for unidentified EMC’s and deterioration of the EMCs. Findings Include: The hospital failed to ensure an appropriate MSE was completed for 1 of 25 patients (Patient 1) who presented to the hospital ED seeking medical care. (Refer to tag A2406) The hospital failed to provide stabilizing treatment for 1 of 25 patients (Patient 1) who presented to the hospital ED seeking medical care for an EMC. (Refer to tag A2407)”

“MEDICAL SCREENING EXAM CFR(s): 489.24(a) & 489.24(c) (a) Applicability of provisions of this section. (1) In the case of a hospital that has an emergency department, if an individual (whether or not eligible for Medicare benefits and regardless of ability to pay) “comes to the emergency department”, as defined in paragraph (b) of this section, the hospital must- (i) Provide an appropriate medical screening examination within the capability of the hospital’s emergency department, including ancillary services routinely available to the emergency department, to determine whether or not an emergency medical condition exists. The examination must be conducted by an individual(s) who is determined qualified by hospital bylaws or rules and regulations and who meets the requirements of §482.55 of this chapter concerning emergency services personnel and direction; and (ii) If an emergency medical condition is determined to exist, provide any necessary stabilizing treatment, as defined in paragraph (d) of this section, or an appropriate transfer as defined in paragraph (e) of this section. If the hospital admits the individual as an inpatient for further treatment, the hospital’s obligation under this section ends, as specified in paragraph (d)(2) of this section. (2)(i) When a waiver has been issued in accordance with section 1135 of the Act that includes a waiver under section 1135(b)(3) of the Act, sanctions under this section for an inappropriate transfer or for the direction or relocation of an individual to receive medical screening at an alternate location do not apply to a hospital with a dedicated emergency department if the following conditions are met: (A) The transfer is necessitated by the circumstances of the declared emergency in the emergency area during the emergency period. (B) The direction or relocation of an individual to receive medical screening at an alternate location is pursuant to an appropriate State emergency preparedness plan or, in the case of a public health emergency that involves a pandemic infectious disease, pursuant to a State pandemic preparedness plan. (C) The hospital does not discriminate on the basis of an individual’s source of payment or ability to pay. (D) The hospital is located in an emergency area during an emergency period, as those terms are defined in section 1135(g)(1) of the Act. (E) There has been a determination that a waiver of sanctions is necessary. (ii) A waiver of these sanctions is limited to a 72-hour period beginning upon the implementation of a hospital disaster protocol, except that, if a public health emergency involves a pandemic infectious disease (such as pandemic influenza), the waiver will continue in effect until the termination of the applicable declaration of a public health emergency, as provided under section 1135(e)(1)(B) of the Act. (c) Use of dedicated emergency department for nonemergency services. If an individual comes to a hospital’s dedicated emergency department and a request is made on his or her behalf for examination or treatment for a medical condition, but the nature of the request makes it clear that the medical condition is not of an emergency nature, the hospital is required only to perform such screening as would be appropriate for any individual presenting in that manner, to determine that the individual does not have an emergency medical condition. This Standard is not met as evidenced by: 51768 Based on record review, policy review, document review and interviews the hospital failed to provide an appropriate medical screening examination (MSE) to determine if an emergency medical condition (EMC) existed for 1 of 25 patients (Patient 1) who presented to the hospital seeking medical care. Failure to provide an appropriate MSE has the potential for all patients to be discharged with an unidentified EMC which causes delays in necessary stabilizing treatment and may lead to deterioration of the person’s condition, including harm and death. Findings Include: Review of hospital policy titled “Patient transfers and Emergency Medical Treatment and Labor ACT (EMTALA), GA-063,” last revised 09/13/24, showed “ ...Psychiatric Emergency Medical Condition: Means a condition that exists when an individual presents an immediate threat to himself or others, for example, the individual has attempted suicide or is violent. Other psychiatric disturbances covered under this regulation includes severe depression, acute psychosis, dis-associative state, inability to comprehend danger or to care for one’s self ...” Review of hospital policy titled “Mental Health Screening and Precautions (Depression / Suicide / Homicide / Gravely Disabled): Emergency Department and Inpatient Hospital Units, PC-221,” last revised on 10/16/25, showed “ ... RN determines the patient’s immediate safety need ... To obtain the full clinical picture, staff should include a review patient’s past medical record (if available) as well as collaborate with patient, family, emergency medical services (EMS), Crisis Intervention Team (CIT) officers, etc. D. In cases where screening scores are low and are not congruent with the patient’s clinical picture: Clinical judgment should be used to support placing the patient at a higher level of acuity and implementing increased safety measures until more in-depth screening occurs by a physician/LIP or clinically trained staff ...” Review of hospital documented titled “Agreement to provide psychiatric mobile response assessments to Saint Luke’s South Hospital” dated 06/08/11, showed “The purpose of this letter is to confirm the agreement between Saint Luke’s Northland Hospital (hereafter, SLN) and Saint Luke’s South Hospital (hereafter, SLS) concerning the psychiatric mobile response assessments SLN will be providing to SLS ... SLN will provide psychiatric mobile response assessment on a 24 hour basis as needed during the term of this agreement. A Mobile Response Clinician will be available to initiate an assessment within approximately 60 minutes for a patient who is experiencing a crisis/emergency and is at risk of self-harm or harm to others ....” Review of hospital document titled “Saint Luke’s South Hospital Medical Staff Rules and Regulations,” amended 08/24, showed “ ...Recommended Consultations - Except in an emergency, consultations are recommended in, but not limited to, the following situations ...when any patient exhibits acute psychiatric manifestations ...” Patient 1 Review of Patient 1’s ambulance report dated 11/05/25 at 2:30 AM, revealed a bystander at a local convenience store called to request emergency medical services (EMS) for Patient 1. Upon EMS arrival, Patient 1 reported having an “anxiety attack” and demonstrated signs & symptoms of “anxiety, restless and agitated.” The Ambulance Report included EMS staff observation of Patient 1 tapping (his/her) lap with (his/her) hand and “doesn’t seem to want to make eye contact.” Patient 1 told EMS staff (he/she) has anxiety, ran out of (anxiety medication) and needed a refill. Patient 1 requested transfer to “any hospital for further evaluation and to get (his/her) medication.” The Ambulance Report reflected while enroute to the ED, EMS staff observed Patient 1 “talking to (his/herself) and patting (his/her) lap which seems to help soothe (him/her).” Review of Patient 1’s medical record dated 11/05/25 showed Patient 1 presented to the hospital’s off-site, provider-based Community Hospital A’s ED at 3:32 AM via ground ambulance with the chief complaint of anxiety and a request for a medication refill for Klonopin, a medication used to treat anxiety. Review of Patient 1’s “ED Notes,” showed “Pt [Patient] demonstrating some self-soothing behaviors upon arrival, most notably tapping and whispering to himself. Pt is calm and cooperative, however, displays behaviors and speech patterns that suggest a possible underlying mental health condition ... Pt agreeable to speaking w/ [with] mental health/crisis team and allowing [County] PD [Police Department] to assist him/transport him. Pt given information for [Community Mental Health Center 1] ...” Review of Patient 1’s medical record showed “ ...Decision has been made to discharge the patient .... Medical Decision Making: I have discussed with the patient that I would refill his blood pressure medication but he is unsure of what the dose is. I do not refill Klonopin prescriptions from the emergency department. Given no acute medical concerns I have referred the patient to [Community Mental Health Center 1] to establish psychiatric care ...” Further review of the ED notes dated 11/05/25 at 4:20 AM showed, Staff G, RN documented, “Pt [Patient 1] ambulates to waiting room w [with]/ a steady gait. ...RN reassured Pt that PD [police department]/crisis team was here to help. Pt agreeable to speaking w/[with] mental health/crisis team and allowing [local] PD” to assist him/transport him. Pt given information for [Community Mental Health Center 1]. Mental health team to provide additional services.” Patient 1 was discharged on 11/05/25 at 4:32 AM with a discharge plan to follow-up at the Community Mental Health Center 1. Hospital staff contacted the local county police department crisis team to provide Patient 1 with an escort to outpatient location. The ED Note lacked evidence of a psychiatric evaluation by qualified medical professional (i.e. behavioral health professional) and lacked evidence of diagnostic tests (i.e. labs, X-Ray, etc), administration of any medication to treat the patient’s reports of anxiety or medication refill as requested. Review of Patient 1’s [Acute Care Hospital B] inpatient record showed Patient 1 presented to the ED on 11/05/25 at 5:02 AM “ ...Chief Complaint ... Suicidal (pt BIBPD [Brought in by Police Department] from [Hospital A] and was discharged. PD was called because pt was not answering SI [Suicidal Ideation] questions. PT [patient] stated to PD that he cam [sic] from Minnesota by train and had an SI attempt 4 days ago by overdosing on unknown pills. Pt is feeling SI today with no plan. Pt is homeless. Pt states he is schizophrenic and has been off his meds x 1 month ...” Patient 1 was petitioned (a legal process used to obtain involuntary admission of an individual into a mental health facility) for psychiatric needs and transferred to dedicated involuntary psychiatric facility. During an interview on 11/17/25 at 3:55 PM, Staff I, Medical Doctor (MD), stated that Patient 1 was discharged to their previous circumstances. Patient 1 wanted to sleep in the hospital lobby, and the plan was for the patient to be taken by the police department’s mental health response team to a community resource center. During an interview on 11/18/25 at 7:45 AM Staff G, RN, stated that they were not able to obtain a history from Patient 1 and that Staff I, MD, sat with the patient trying to obtain more history. The patient was experiencing some underlying mental health condition as they were self-soothing and rhythmically tapping. The patient was minimally interactive, not cooperative, and “kind of in his own little world.” The patient was discharged to the waiting room, and the police department was called. The police department has its own screening process and was going to take the patient as long as Patient 1 was willing to go with them.”

“STABILIZING TREATMENT CFR(s): 489.24(d)(1-3) (1) General. Subject to the provisions of paragraph (d)(2) of this section, if any individual (whether or not eligible for Medicare benefits) comes to a hospital and the hospital determines that the individual has an emergency medical condition, the hospital must provide either- (i) within the capabilities of the staff and facilities available at the hospital, for further medical examination and treatment as required to stabilize the medical condition. (ii) For for transfer of the individual to another medical facility in accordance with paragraph (e) of this section. (2) Exception: Application to inpatients. (i) If a hospital has screened an individual under paragraph (a) of this section and found the individual to have an emergency medical condition, and admits that individual as an inpatient in good faith in order to stabilize the emergency medical condition, the hospital has satisfied its special responsibilities under this section with respect to that individual (ii) This section is not applicable to an inpatient who was admitted for elective (nonemergency) diagnosis or treatment. (iii) A hospital is required by the conditions of participation for hospitals under Part 482 of this chapter to provide care to its inpatients in accordance with those conditions of participation. (3) Refusal to consent to treatment. A hospital meets the requirements of paragraph (d)(1)(i) of this section with respect to an individual if the hospital offers the individual the further medical examination and treatment described in that paragraph and informs the individual (or a person acting on the individual’s behalf) of the risks and benefits to the individual of the examination and treatment, but the individual (or a person acting on the individual’s behalf) does not consent to the examination or treatment. The medical record must contain a description of the examination, treatment, or both if applicable, that was refused by or on behalf of the individual. The hospital must take all reasonable steps to secure the individual’s written informed refusal (or that of the person acting on his or her behalf). The written document should indicate that the person has been informed of the risks and benefits of the examination or treatment, or both. This Standard is not met as evidenced by: 51768 Based on record review, policy review, document review, and interviews, the hospital failed to provide stabilizing treatment for 1 of 25 patients (Patient 1) who presented to the emergency department (ED) seeking medical care. Failure to provide stabilizing treatment has the potential to place patients at risk for deterioration of an emergency medical condition (EMC), causing harm or injury. Findings Include: Review of hospital policy titled “Patient transfers and Emergency Medical Treatment and Labor Act (EMTALA), GA-063,” last revised 09/13/24 showed “ ... The medical screening examination is an ongoing process and the medical records must reflect continued monitoring based on the patient’s needs and must continue until patient is either Stabilized or appropriable transferred ... Stable or Stabilized Means: ... With respect to an individual with an emergent psychiatric condition, that the individual is protected and prevented from injuring himself/herself or others during transfer or is no longer considered to be a threat to himself/herself or others and therefore may be discharged .... If the patient cannot be Stabilized at the Hospital’s off campus facility, the Hospital must either transport the patient to the Hospital’s main campus or provide for Transfer ....Stable For Discharge - A patient is considered stable for discharge when, within reasonable clinical confidence, it is determined that the patient has reached the point where his or her continued care, including diagnostic work-up and/or treatment, could be subsequently performed as an inpatient or outpatient, provided the patient is given a plan for appropriate follow-up care with the discharge instructions. With respect to a patient with a psychiatric condition, the patient is considered to be stable for discharge when the physician has determined that the patient is no longer considered to be a threat to himself/herself or to others ...” Review of hospital policy titled “Mental Health Screening and Precautions (Depression / Suicide / Homicide / Gravely Disabled): Emergency Department and Inpatient Hospital Units, PC-221,” last revised on 10/16/25, showed “ ... RN determines the patient’s immediate safety need ... To obtain the full clinical picture, staff should include a review patient’s past medical record (if available) as well as collaborate with patient, family, emergency medical services (EMS), Crisis Intervention Team (CIT) officers, etc. D. In cases where screening scores are low and are not congruent with the patient’s clinical picture: Clinical judgment should be used to support placing the patient at a higher level of acuity and implementing increased safety measures until more in-depth screening occurs by a physician/LIP or clinically trained staff ...” Review of hospital document titled “Saint Luke’s South Hospital Medical Staff Rules and Regulations,” amended 08/24, showed “ ...Recommended Consultations - Except in an emergency, consultations are recommended in, but not limited to, the following situations ...when any patient exhibits acute psychiatric manifestations ...” Patient 1 Review of Patient 1’s ambulance report dated 11/05/25 at 2:30 AM, revealed a bystander at a local convenience store called to request emergency medical services (EMS) for Patient 1. Upon EMS arrival, Patient 1 reported having an “anxiety attack” and demonstrated signs & symptoms of “anxiety, restless and agitated.” The Ambulance Report included EMS staff observation of Patient 1 tapping (his/her) lap with (his/her) hand and “doesn’t seem to want to make eye contact.” Patient 1 told EMS staff (he/she) has anxiety, ran out of (anxiety medication) and needed a refill. Patient 1 requested transfer to “any hospital for further evaluation and to get (his/her) medication.” The Ambulance Report reflected while enroute to the ED, EMS staff observed Patient 1 “talking to (his/herself) and patting (his/her) lap which seems to help soothe (him/her).” Review of Patient 1’s medical record dated 11/05/25 showed Patient 1 presented to the hospital’s off-site, provider-based Community Hospital A’s ED at 3:32 AM via ground ambulance with the chief complaint of anxiety and a request for a medication refill for Klonopin, a medication used to treat anxiety. Review of Patient 1’s “ED Notes,” showed “Pt [Patient] demonstrating some self-soothing behaviors upon arrival, most notably tapping and whispering to himself. Pt is calm and cooperative, however, displays behaviors and speech patterns that suggest a possible underlying mental health condition ... Pt agreeable to speaking w/ [with] mental health/crisis team and allowing [County] PD [Police Department] to assist him/transport him. Pt given information for [ Community Mental Health Center 1] ...” Review of Patient 1’s medical record showed “ ...Decision has been made to discharge the patient .... Medical Decision Making: I have discussed with the patient that I would refill his blood pressure medication, but he is unsure of what the dose is. I do not refill Klonopin prescriptions from the emergency department. Given no acute medical concerns I have referred the patient to [Community Mental Health Center 1] to establish psychiatric care ...” Further review of the ED notes dated 11/05/25 at 4:20 AM showed, Staff G, RN documented, “Pt [Patient 1] ambulates to waiting room w [with]/ a steady gait. ...RN reassured Pt that PD [police department]/crisis team was here to help. Pt agreeable to speaking w/[with] mental health/crisis team and allowing [local] PD” to assist him/transport him. Pt given information for [Community Mental Health Center 1]. Mental health team to provide additional services.” Patient 1 was discharged on 11/05/25 at 4:32 AM with a discharge plan to follow-up at Community Mental Health Center 1. Hospital staff contacted the local county police department crisis team to provide Patient 1 with an escort to outpatient location. Patient 1’s medical record lacked evidence of a psychiatric evaluation by qualified medical professional (i.e. behavioral health professional) and lacked evidence of diagnostic tests (i.e. labs, X-Ray, etc), administration of any medication to treat the patient’s reports of anxiety or medication refill as requested. The hospital failed to utilize available resources for further medical examination and treatment as required to stabilize Patient 1’s medical condition. Review of Patient 1’s [Acute Care Hospital B] inpatient record showed Patient 1 presented to the ED on 11/05/25 at 5:02 AM “ ...Chief Complaint ... Suicidal (pt BIBPD [Brought in by Police Department] from [Hospital A] and was discharged. PD was called because pt was not answering SI [Suicidal Ideation] questions. PT [patient] stated to PD that he cam [sic] from Minnesota by train and had an SI attempt 4 days ago by overdosing on unknown pills. Pt is feeling SI today with no plan. Pt is homeless. Pt states he is schizophrenic and has been off his meds x 1 month ...” Patient 1 was petitioned (a legal process used to obtain involuntary admission of an individual into a mental health facility) for psychiatric needs and transferred to dedicated involuntary psychiatric facility. During an interview on 11/17/25 at 3:55 PM, Staff I, Medical Doctor (MD), stated that Patient 1 was discharged to their previous circumstances. Patient 1 wanted to sleep in the hospital lobby, and the plan was for the patient to be taken by the police department’s mental health response team to a community resource center. During an interview on 11/18/25 at 7:45 AM Staff G, RN, stated that they were not able to obtain a history from Patient 1 and that Staff I, MD, sat with the patient trying to obtain more history. The patient was experiencing some underlying mental health condition as they were self-soothing and rhythmically tapping. The patient was minimally interactive, not cooperative, and “kind of in his own little world.” The patient was discharged to the waiting room, and the police department was called. The police department has its own screening process and was going to take the patient as long as Patient 1 was willing to go with them.”

“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: 52950 Based on record review, policy review, document review, and interview the hospital failed to ensure it met the requirements for Nursing Services Condition of Participation by failing to ensure nursing staff identified, documented, and reported adverse drug reactions (ADRs) in accordance with hospital policies for 1 (Patient 1) of 12 sampled patients. This deficient practice has the potential to affect all patients receiving services at this hospital resulting in adverse patient outcomes. Findings Include: 1. The hospital failed to ensure nursing staff identified, documented, and reported adverse drug reactions (ADRs) in accordance with hospital policies. (Refer to A-0395) 2. The hospital failed to follow their procedure for reporting adverse drug reaction. (Refer to A-0411)”

“RN SUPERVISION OF NURSING CARE CFR(s): 482.23(b)(3) A registered nurse must supervise and evaluate the nursing care for each patient. This Standard is not met as evidenced by: 52950 Based on policy review, document review, record review and interview, the hospital failed to ensure that nursing staff evaluated and reported a patient’s adverse drug reaction (ADR) in accordance with policy for 1 (Patient 1) of 12 patients reviewed . The hospital failure to ensure that ADRs are evaluated and reported has the potential to result in delay in medical intervention and increase risk of patient harm. Findings Include: Review of hospital policy titled, “Medication Administration and Documentation, PC-212”, effective date 2/19/2025, showed,” ...9. Reportable Conditions: A. Any Adverse Drug Reaction (defined as any serious or significant side effect, injury, toxicity, sensitivity reaction, or bioequivalence [the biochemical similarity between two drugs with the same active ingredients and desired outcomes for patients)] problem associated with the therapeutic or diagnostic use of a drug) should be reported in the incident reporting system and reported to the LIP [licensed independent practitioner] ...” Review of hospital policy titled, “Medication - Incident and Adverse Drug Reaction, GA-514”, last revised date 02/17/25, showed, “ ...When medication incidents occur, they will be reported in a timely manner via the online Incident Reporting System and brought to the attention of the health care team. This policy will describe the process for monitoring and reporting medication incidents including medication errors, adverse drug events (ADEs) and adverse drug reactions (ADRs)” “ ... III. Adverse Drug Event (ADE): Harm experienced by a patient as a result of exposure to a medication. The occurrence of an ADE does not necessarily indicate an error or poor-quality of care, and can be considered preventable or potential: A. Preventable ADE: medication error that reaches a patient and causes any degree of harm. B. Potential ADE: medication error that has the potential to cause harm but does not because of specific circumstances, chance, or because the error is intercepted and corrected prior to reaching the patient . ...IV . Adverse Drug Reaction (ADR): Any unexpected, unintended, undesired or excessive response to a medication; this includes events that cause harm due to a medication administered without error in the medication use process that: A. Requires discontinuing the drug (therapeutic or diagnostic) B. Requires changing the drug therapy C. Requires modifying the dose (except for minor dosage adjustments) D. Necessitates admission to a hospital E. Prolongs stay in a health care facility F. Necessitates supportive treatment G. Significantly complicates diagnosis H. Negatively affects prognosis, or I. Results in temporary or permanent harm, disability, or death ...” Patient 1 Review of Patient 1’s medical record showed, an 84-year-old, transferred on 09/04/25 with hyponatremia (low levels of sodium in blood). During admission Patient 1 developed worsening mental status and encephalopathy (change in how your brain functions), prompting neurology and infectious disease consultations. Electroencephalogram (EEG - medical procedure that measures the electrical activity of the brain) revealed generalized periodic discharges consistent with cefepime toxicity. Cefepime (antibiotic) was discontinued. Review of Patient 1’s medical record, dated 09/05/25 at 5:34 PM, showed the pharmacy consulted to dose cefepime for pneumonia. “ ... Based on current pharmacokinetic parameters the patient will be started on cefepime 2 g [gram] IV [intravenous] every 8 hours ...” Review of Patient 1’s medical record orders on 09/08/25 at 12:38 PM, showed that cefepime 2 g IV decreased every 12 hours. Review of Patient 1’s “Medication Administration Record,” dated 09/05/25 at 5:34 PM, showed, Cefepime every 8 hours intravenous (IV) push with 20 milliliter ( ml) of sterile water and give over 3 to 5 minutes, given on 09/05/25 at 6:35 PM, 09/06/25 at 2:13 AM, 09/06/25 at 10:39 AM, 09/06/25 at 6:26 PM, 09/07/25 at 2:27 AM, 09/07/25 at 10:49 AM, 09/07/25 at 5:45 PM, 09/08/25 at 2:20 AM, 09/08/25 at 8:39 AM, and 09/08/25 at 8:46 PM. Review of Patient 1’s medical record, “Neurology Consultation,” dated 09/09/25 at 9:00 AM showed, “ ... Acute encephalopathy multifactorial in the setting of metabolic disturbances (hyponatremia, anemia, elevated creatinine), prolonged hospitalization, impaired sleep-wake cycle, malnutrition, induced antibiotic (cefepime), initially sedating medications at his age (Flexeril) ...” ’ ...Recommendations ... If able please stop cefepime, and choose a different antibiotic ...” Review of an “Order” dated 09/09/25 at 10:14 AM, by Staff L, MD, showed cefepime held by provider because of a mental status change. Review of Patient 1’s electroencephalogram (EEG) dated 09/10/25 at 4:32 PM, showed, “ ...GPD’s (generalized periodic discharges) as described above, consistent with cefepime toxicity ...” Review of Patient 1’s medical record, “Neurology Progress Note”, dated 09/11/25 at 2:16 PM, showed, “ ... Overnight, patient [Patient 1] mentation continues to worsen. Today, family meeting was initiated with Palliative Care team in regards to patient current mentation. Discussed with family that from a neurological perspective patient is dealing with acute multifactorial encephalopathy. Explained to family that factors that could be contributing to his poor meditation are cefepime [antibiotic] toxicity which was noted on EEG , impaired kidney function, malnutrition, prolonged hospitalization, infection (pneumonia), impaired sleep-wake cycle, anemia. discussed that MRI [ magnetic resonance imaging] of the head was negative for any acute abnormalities. Again, discussed in great lengths regarding the EEG findings and how antibiotic cefepime could be playing a primary contributing factor ...” Review of Patient 1, “Certification of Death”, date certified 09/12/25, showed, cause of death: “Acute Encephalopathy, Cefepime Toxicity, Malnutrition, Multifactorial, PNA.” [pneumonia] Review of a hospital document titled, “Incident Report Log 04/01/2025 through 10/05/2025” failed to show documentation of Patient 1’s Medication/Adverse Drug Reaction, a reportable condition. During an interview on 10/08/25 at 9:29 AM, Staff L, Medical Doctor (MD ), stated that, cefepime, an antibiotic, can cause acute mental status changes. It’s not preferred to use it frequently; it is often the most effective antibiotic for pneumonia when supported by culture and sensitivity results. Pharmacy assists in verifying renal function to ensure patients are cleared to safely receive the medication. In most cases, patients’ mental status improves once cefepime is discontinued . During an interview on 10/08/25, at 10:35 AM, Staff K, Doctor of Pharmacy (Pharm D), stated that the pharmacy assists in selecting antibiotics based on culture results. Initially, the broadest-spectrum antibiotic is chosen, and once culture results are available, the team works to select an antibiotic specifically targeted to the identified organism. The primary prescribing decision remains with the physician, though it is usually a collaborative process between pharmacy and the physician. Cefepime can cause adverse reactions. If a patient experiences an adverse reaction, the antibiotic would be switched. In Patient 1, cefepime was originally ordered at 9/05/25 every 8 hours, stopped on 09/07/25, restarted on 09/08/25 every 12 hours, and finally discontinued by the physician on 09/09/25, per infectious disease recommendations. The pharmacist indicated they are not aware of this being formally reported as an adverse drug reaction.”

“REPORTING ADVERSE REACTIONS AND ERRORS CFR(s): §482.23(c)(5) - There must be a hospital procedure for reporting transfusion reactions, adverse drug reactions, and errors in administration of drugs. This Standard is not met as evidenced by: 52950 Based on policy review, record review and interview, the hospital failed to follow their procedure for reporting adverse drug (ADR) reaction for 1 patient (Patient 1) of 12 sampled patients. The hospital failure to ensure that an identified ADR was reported has the potential to affect patient safety and the ability to monitor and prevent medication related adverse events. Findings Include: Review of hospital policy titled, “Medication Administration and Documentation, PC-212”, effective date 02/19/25, showed,” ...9. Reportable Conditions: A. Any Adverse Drug Reaction (defined as any serious or significant side effect, injury, toxicity, sensitivity reaction, or bioequivalence (the biochemical similarity between two drugs with the same active ingredients and desired outcomes for patients) problem associated with the therapeutic or diagnostic use of a drug) should be reported in the incident reporting system and reported to the LIP (licensed independent practitioner) ...” Patient 1 Review of Patient 1’s medical record showed, an 84-year-old, transferred on 09/04/25 with hyponatremia (low levels of sodium in blood). During admission Patient 1 developed worsening mental status and encephalopathy (change in how your brain functions), prompting neurology and infectious disease consultations. Electroencephalogram (EEG - medical procedure that measures the electrical activity of the brain) revealed generalized periodic discharges consistent with cefepime toxicity. Cefepime was discontinued. Review of Patient 1’s “Order” dated 09/09/25 at 10:14 AM, by Staff L, MD, showed Cefepime (antibiotic used to treat a wide range of severe bacterial infections) held by provider mental status change . Review of Patient 1’s EEG dated 09/10/25 at 4:32 PM, showed, “ ...GPD’s (generalized periodic discharges) as described above, consistent with cefepime toxicity ...” Review of a hospital document titled, “Incident Report Log 04/01/2025 through 10/05/2025” failed to show documentation of Patient 1’s Medication/Adverse Drug Reaction, a reportable condition. During an interview on 10/08/25, at 10:35 AM, Staff K, Pharm D, stated that pharmacy assists in selecting antibiotics based on culture results. Initially, the broadest-spectrum antibiotic is chosen, and once culture results are available, the team works to select an antibiotic specifically targeted to the identified organism. The primary prescribing decision remains with the physician, though it is usually a collaborative process between pharmacy and the physician. Cefepime can cause adverse reactions. If a patient experiences an adverse reaction, the antibiotic would be switched. In Patient 1, cefepime was originally ordered at 9/05/25 every 8 hours, stopped on 09/07/25, restarted on 09/08/25 every 12 hours, and finally discontinued by the physician on 09/09/25, per infectious disease recommendations. The pharmacist indicated they are not aware of this being formally reported as an adverse drug reaction.”