HCA Florida Blake Hospital

“PATIENT SAFETY CFR(s): 482.21(a), (c)(2), (e)(3) (a) Standard: 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 ... identify and reduce medical errors. (2) The hospital must measure, analyze, and track ...adverse patient events ... (c) Program Activities ..... (2) Performance improvement activities must track medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning throughout the hospital. (e) Executive Responsibilities, 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: ... (3) That clear expectations for safety are established. This Standard is not met as evidenced by: 43147 Based on medical record review, facility document and policy review, and staff interviews, the facility failed to identify opportunities for improvement and develop an effective plan of correction for an adverse event involving the disposition of a donor’s body for one (1) out of five (5) donors reviewed (Donor #1). The findings include: Donor #1’s was admitted to the hospital on 05/23/25 status post fall with a diagnosis of catastrophic brain injury. The OPO obtained consent on 05/29/25 at 4:00 p.m. for organs, skin, bone, and blood vessels of the lower extremities. Donor #1 expired on 05/31/25 prior to organ donation. Donor #1’s body was released from the hospital and transported to the OPO’s Tissue Bank on 05/31/25 at 11:36 p.m. Review of the Donor #1’s “Expiration Record Physician Documentation” dated 05/31/25 revealed under “DISPOSITION OF BODY:” body to Morgue at 1858 by security officer’s name and above information verified by illegible name and title “RN.” Under “AUTHORIZATION TO RELEASE BODY:” listed authorized release of body to funeral home name and contact information that the funeral home was notified on 05/31/25 at 1940. Review of the hospital’s Expiration Log entry dated 05/31/25 revealed under the column “NAME OF FUNERAL HOME CONTACTED DATE/ TIME” was the name of transportation company, no date or time, and an illegible name and under the column “RELEASED BY DATE/TIME” read an illegible name with the date and time of 05/31/25 at 2248. During an interview on 12/03/25 at 11:08 a.m. with the Security Officer, he stated that they are responsible for transporting deceased patients to the morgue and releasing the body to the transport company based on the documentation. He stated the “Expiration Record Physician Documentation” forms are in the Nursing Supervisors’ office and based on that form, they verified correct patient and company, and then the company and security sign off on the form and released the body. During an interview on 12/03/25 at 11:19 a.m. with the Nursing Supervisor, she stated that based on the current process and the “Expiration Record Physician Documentation” and the hospital’s “Expiration Log” for Donor #1, she was unable to determine who was responsible for the body nor was she able to determine where the body went. During an interview on 12/02/25 at 2:44 p. m. with the Vice President of Quality and Patient Safety, she stated that she was aware that Donor #1’s family thought the body was being released to the funeral home. She stated that when the family inquired about the location of the body on 06/01/25, the hospital had a process and documentation that was unclear and therefore they were unable to determine the body’s location. She stated that this adverse event was not discussed at the quarterly Quality Assurance Performance Improvement (QAPI) meeting, nor was there a formal investigation with process improvements to include nursing and security. She stated that the hospital only added an additional column to “Expiration Log.” She stated that the expectation was that an analysis of the issue and process improvement should have been completed and discussed with QAPI. Review of the Security Standard Operating Procedure (SOP), undated, read, “ ...Deceased Patient Morgue Response ...2. The officer will transport deceased patients to the morgue from any department in the hospital 24 hours a day. 3. The officer will log all expirations, in and out, in the morgue logbook kept in the security office. 4. The eye / tissue bank will notify the nursing supervisor if the deceased patient should be held or released. 5. The nursing supervisor will review paperwork to determine if the case is for the Medical Examiner and if so, only the ME can release the patient. 6. The officer will respond to the nursing supervisor’s office to gather paperwork to be signed by the transporting company when releasing a decedent. The officer will sign for release with the transport company at the bottom of the form ...” Review of the policy titled “End of Life Issues,” reviewed 04/25, read “ ...F. Nursing shall notify proper authority/department as appropriate. 1. LifeLink/CFLETB at 1-800-643-6677. 2. If Medical Examiner’s case, District Twelve office at 361-6909 (see Medical Examiner’s Cases section below). 3. Security a. Provide Security with name of patient, date and time of death, and if Medical Examiner case. b. Notify Security if name of funeral home is known and any other pertinent information. 4. Attending physician and all consultants. 5. Clinical Supervisor ...” Review of the “2025 QAPI,” undated, read “ ... QAPI Program provides an ongoing, systematic approach to plan, measure, evaluate and improve clinical and operational performance, safety, and service. The fundamental objectives of the program are to ...Plan, design, or revise processes of care and service delivery ...Identify opportunities for improvement and utilize and interdisciplinary approach to develop and implement solutions and action plans ... Utilize valid data collection techniques and analysis in QAPI initiatives ... Involve staff, leadership and providers in QAPI initiatives ...Achieve high-level customer satisfaction ... Communicate the QAPI Program finding and results of improvement efforts ... When a project or process improvement opportunity is identified, QI teams will initially review available data, identify customers impacted and evaluate, prioritize and select projects ... Appropriate action, including root cause analysis, will be undertaken by the QC, Director of Patient Safety, Medical Director, or an ad hoc team created to address a specific issue. The BOT is ultimately responsible for assuring action is taken ...””

“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: 36678 Based on medical records, facility policies and interviews, the hospital failed to ensure the safety of one patient (Patient #1) related to timely identification, appropriate interventions for a potentially reversible change of condition. The facility failed to follow the standard of practice for obtaining ordered labs, vital signs, and change of condition and critical lab reporting. Findings included: Review of the medical record for Patient #1 reflected he came to the ED (Emergency Department) on 5/11/25 at 9:58 AM by EMS (Emergency Medical Services) for frequent falls. He had a medical history which included Parkinson’s disease (a progressive neurological disorder that primarily affects movement, causing symptoms like tremors, stiffness, and slowness of movement). He was diagnosed with a urinary tract infection (UTI) and was admitted for further workup and management of Parkinson’s, and frequent falls. In the ED, blood cultures (a laboratory test that checks for bacteria, yeast, or other microorganisms to determine if a bloodstream infection is present) were ordered by the ED Physician. There was no evidence that the blood cultures were drawn. These blood cultures were automatically canceled after 48 hours by the electronic ordering system. Patient #1 was admitted to the medical-surgical unit, where he remained throughout his stay until his death on 5/16. The medical record showed on 5/15/25 Staff C, RN (Registered Nurse) notified Staff B, DO (Doctor of Osteopathy) by phone that Patient #1’s blood chemistry test was abnormal with a sodium level of 164 (135-145 is normal) and CO2 (carbon dioxide) less than 10. Staff B, DO ordered blood cultures again. On 5/15/25 at 5:25 PM a stat (immediate) order was entered for blood cultures. Lab comments stated the patient was “not available”, and labs were not drawn. A critical lactic acid level (5.7) (Lactic Acid is a chemical compound produced by the body when it breaks down glucose for energy in the absence of sufficient oxygen. Lactic acid levels above 7-8 mEq/L are generally associated with a fatal outcome.) was identified on 5/16 at 12:22 AM and called to the nurse, but no evidence in the medical record it was reported to a physician. Lab tests drawn on 5/15 showed Patient #1’s WBCs (white blood cells) were 26.1 (normal is 4.5-11), RBC (Red Blood Cells) 6.51 (normal is 4.63-6.08), Hgb (Hemoglobin) was 19.7 (normal is 13.7-17.5) and lactic acid 3.5 (normal is 0.4-2.0). The lactic acid was reported to the on-call physician, but there was no evidence in the medical record that the physicians were notified of the white blood cell count. The last set of documented vital signs for Patient #1 was on 5/15/25 at 8:11 AM. The only vital signs documented on the night shift of 5/15/25 was a temperature at 8:08 PM of 40.1 C (104.3 F). There was no documentation that the temperature was reported to a physician. On 5/16/25 at approximately 4:00 AM Staff G, PCT (Patient Care Technician) notified Staff D, RN that Patient #1 was unresponsive, and a Code Blue (Cardiac arrest) was called. After CPR (cardiopulmonary resuscitation) was performed and several rounds of emergency medications were given, death was pronounced by the physician at 4:13 AM. During a telephone interview on 6/11/2025 at 2:14 PM Staff E, PCT (Patient Care Technician), she stated that she covered Staff G, PCT’s break for lunch around 3 AM, who was sitting with Patient #1. Staff E, PCT said she was with him for maybe 10 minutes. Patient #1 was making weird breathing sounds. But PCT, Staff G told her it was because of his Parkinson’s tremors. He seemed very short of breath. He was not on oxygen, probably because he wouldn’t keep anything on. He had tremors, like the shakes. His eyes weren’t open. The nurse came in and checked on the patient around 3:35 AM. He checked the patient’s IV (intravenous) fluids and changed the bag out, and he checked the patient. Then he left. The sitter (Staff G, PCT) came back around 3:42 AM when her break was over. A few minutes later Staff G, PCT ran out and grabbed the vital signs machine, and then a minute later the nurse came running in. A few seconds later the Code Blue alarm went off. During a telephone interview on 6/11/25 at 2:51 PM with Staff B, DO, Patient #1’s hospital physician, she disclosed that orders get auto canceled by the system if they’re not collected. There was no follow up on blood cultures. The system canceled them. Staff B, DO said she saw that the blood cultures were auto canceled, so she ordered them again. She said she thinks she ordered them routine (collected within 24 hours), the day before he passed, because he had a change of condition. Staff B, DO said he did have a positive urinalysis (UA). She doesn’t recall if the cultures grew anything. Urine cultures can take 2 to 3 days. Patient #1 got worse throughout the hospitalization. Staff B, DO disclosed she was never notified of the lactic acid results after the first one, and the on-call after hours wasn’t notified either. Staff B, DO said she consulted nephrology for the high sodium and ordered fluids and sodium bicarbonate. Staff B, DO also stated she was not notified of the elevated temperature either. Staff B, DO stated she was not notified of a change in his clinical condition. During a telephone interview on 6/11/2025 at 3:17 PM with the ED Medical Director, he said he expects that all ordered labs in the ED would be drawn. During an interview on 6/11/25 at 4:38 PM with Staff A, ED RN (Registered Nurse), she said the blood cultures shouldn’t have been missed. The ER (Emergency Room) nurse draws the blood cultures. She was not aware that they were not drawn. During an interview on 6/12/25 at 10:12 AM, Staff C, RN, said she cared for Patient #1 only once, on the day before he passed. She told Staff B, DO about the sodium and another physician who was on-call, about the lactic acid. Staff B, DO consulted nephrology. Staff B, DO spoke to the Nephrologist on the phone and ordered start D5 (Dextrose 5%) intravenously (IV) and sodium bicarbonate (a medication to treat severe metabolic acidosis). Staff B, DO put the orders in for the IV fluids the Nephrologist wanted. Staff C, RN said she got report from Staff D, RN. Patient #1 was diaphoretic (perspiring/sweating), shaking and non-verbal, but awake and confused. He had a sitter and was on the camera monitor. His vital signs were normal. He was not on a heart monitor, so the vital signs are done every shift. He was mouth breathing. Staff B, DO saw him around 8 or 9 AM and his family was at the bedside. Staff B, DO rounded again in the afternoon. Neurology was seeing him and changed his Parkinson’s medications, because he wasn’t able to swallow. He made his medications sublingual (dissolvable under the tongue) and IV (intravenous). He had oral Tylenol ordered. His doctors saw him. They said it was because he hadn’t had his Parkinson’s medications. The plan was to switch his medications and monitor him. It was late on her shift when the lab results came. He got a Foley (urinary catheter) for strict I and O (intake and output). The interventions were implemented. There is no charge on nights shift. The night charge has been out on leave for months. There isn’t another charge on nights. In a telephone interview with Staff G, PCT (Patient Care Technician) on 6/12/235 at 11:22 AM, she stated Patient #1 was fine when she came in. He was sleeping. He woke up a few times and went back to sleep. He was shaking the whole time because he has Parkinson’s. Around 3 AM he started having a change in his breathing. Staff G, PCT stated she went on break and when she returned, she noticed the change. He wasn’t shaking anymore. She said something told her something was off. Around 3:55 AM it sounded like he took his last breath. She said she went to get the vital signs machine and when she touched him, he felt cold. He wouldn’t wear a gown, so he had a blanket on. Staff G, PCT stated she couldn’t get any vital signs and so she yelled for the nurse. She told the nurse he wasn’t answering and was unresponsive. He looked like he was turning blue, and she thought he took his last breath. The nurse came in and called the patient’s name. He wasn’t moving. The nurse (Staff D, RN) pulled the Code Blue cord and started CPR. Another PCT came in and took over, and within a minute everybody was in the room taking turns. A doctor came less than a minute after everyone else. On 6/12/25 at 11:59 AM Staff D, RN was interviewed via telephone. Staff D, RN disclosed he had Patient #1 two or three times. He had Parkinson’s shaking and had slipped and fallen in the room. He was combative. Staff D, RN said he took report from the day shift when he came in that day. Staff C, RN told him the lactic acid and carbon dioxide were critical and that she called the doctor, and the doctor was aware. She said the doctor ordered fluids. An elevated lactic means acidosis. After report he saw Patient #1. He was sleeping. He hadn’t slept in 3 or 4 days. When Staff D, RN checked on him he was breathing fine. His breathing was normal at that time. The night before he took his pills by mouth, but on the day shift that day he was spitting them out. He was confused. Staff D, RN said he tried to get vitals but Patient #1 was fighting it. He pulled the blood pressure cuff off. He was fighting, so Staff D, RN wasn’t able to get his vital signs. Staff D, RN admitted he did not notify the doctor. The technician got his temperature. He went in and rechecked it. It was high but not as high as what she charted. It was 100.6 F when he rechecked it. He didn’t save it from the blood pressure machine, so it was not documented. The parameter on the Tylenol is if it’s more than 100.5. Staff D, RN said he gave a Parkinson’s medication under Patient #1’s tongue and got called to take care of another patient. He left the Tylenol on the bedside table. He had 6 patients and there was no charge nurse that night. He doesn’t know if the lab came up to draw the cultures. Right before 4 AM, around 3:40 maybe, the sitter [Staff G, PCT] came and said the patient wasn’t breathing. Staff D, RN stated that he went in the room and saw Patient #1 was unresponsive, so he pulled the cord [to notify all staff of a cardiac arrest], and started CPR right away. Someone brought the crash cart to the bedside. CPR was performed for 20 to 25 minutes, and then the doctor called the time of death. In an interview with the VPQ (Vice President of Quality) on 6/12/25 at 12:10 PM she stated she asked Staff D, RN if he understood the policy [Standard of Care] and he said he did. He was very honest. He said the patient was sleeping and he didn’t want to wake him up. I asked him again if he understood the policy. He said he did. On 6/12/25 at 1:52 PM the Chief Medical Officer (CMO) was interviewed. Regarding Patient #1, he said he was not sure why the antibiotics were started. They ordered blood cultures. He was shaking a lot, and they couldn’t get the blood cultures. He was on a broad-spectrum antibiotic. He really seemed to take a turn on the last day. He may have developed an infection around the 12th, but he was on already on Rocephin. The critical lab values weren’t called for the lactic acidosis. He was acidotic. He had renal tubular necrosis. He was in acute renal failure. Nephrology was consulted and fluids started. The care was appropriate up until the lack of reporting the critical labs. The patient was being observed by a sitter, but the communication wasn’t there. The staff were saying they were unable to take his blood pressure because he was refusing and shaking. They weren’t drawing blood cultures because of his tremors. Even if he was transferred to a higher level of care, the care would have been the same. Although the blood cultures weren’t drawn, he was on a broad-spectrum antibiotic, and so he probably would not have had a different outcome. The cultures would have been moot by then anyway because he had already received the antibiotics. I think something very catastrophic happened. Renal failure. Dehydration could have been a factor. He was probably pre-renal. We have a ‘ticket to test’ algorithm. It’s part of antibiotic stewardship. It’s a form with the criteria for a blood culture. If it doesn’t meet the criteria, then it is escalated to the supervisor. The supervisor reviews it for criteria. If the ‘ticket to test’ shows that the algorithm stops then the house supervisor or chair or myself will talk to the practitioner. We try to encourage them to adhere to the criteria. It’s the discretion of the doctor. Cultures are overdrawn in the hospital, but ultimately the physician makes that decision. The hospital doesn’t cancel them. There is a list generated of unfulfilled lab orders shift to shift. The lab needs to pay more attention. At 2:30 PM on 6/12/25 a follow up interview was conducted with Staff A, ED RN. Staff A, RN said admissions involve a ton of orders. The admitting doctor orders more. If there are new admitting orders, they go to lab. The ED nurse is still caring for the patient. They are still the ED nurse’s responsibility. The blood cultures should have been drawn here. It’s the ED’s responsibility to do ED orders, whether the patients are holding or they go to the floor. During an interview on 6/12/25 at 3:04 PM Staff H, phlebotomist stated if the patient came from ED it [lab test] is drawn right away. We don’t wait for a paper. That is the only comment they have that you can put. It’s an auto comment. It’s either ‘patient unavailable, refused, or getting transfusion’. They need to change it. ‘Patient unavailable’ could mean a lot of things. Staff H, phlebotomist said she doesn’t remember the patient. She stated she always tells the nurse if the patient is unavailable or refused. If something is pending, “I don’t let it sit.” Staff H said she has only had access to comments for a week. The lead would have put the comment in. The comment would be under her name. She hasn’t had computer access until this week. If stuff gets missed, it has to be collected. Lab doesn’t go to the ED. But if it wasn’t done, then lab will go draw it. ‘Unavailable’ could be refused. If the patient refuses, then try to explain the reason for the lab, and if they still refuse, tell the nurse. Sometimes they can talk to the patient into it. On the form ID there has to be 3 signatures for the blood cultures; the nurse, the charge and the doctor, unless it’s a patient who just came from the ED. It can’t be drawn without their signatures. It’s a piece of paper with arrows on it. The Resident doctor can’t sign it either. The nurses on the floors know. They all have papers to fill out for blood cultures. The Lab Director was interviewed at 3:47 PM on 6/12/25. The phlebotomist, Staff H, has access in the electronic system to put comments in. But the comments are very limited. The only comment she was able to put in was ‘patient unavailable’ at the time in the electronic system. If she was waiting for permission from the nurse to draw it, then the only comment she would have entered was ‘unavailable’. “We pulled the cameras to make sure she did go to the nurse, and she did.” Usually, they ask the nurse to fill out the form to make sure it is not being collected unnecessarily. It usually has to be signed by the doctor. The ED gets blood cultures on everybody, and there was a shortage of blood culture supply bottles a few months ago. This was not flagged at all. It auto cancels after 2 days. Often times the order just wasn’t entered right. If it auto cancels, the doctor may have to put the order in again. The Lab Director said she was not aware it was an issue until they brought it to her attention, because it auto canceled. ED didn’t collect it, and she assumed they didn’t want it, but didn’t put in a cancellation. During an interview on 6/13/25 at 9:11 AM with the VPQ and the Director of Patient Safety, the VPQ stated Patient #1 was found unresponsive by the sitter. He was not doing well, and they had changed his medications. The blood cultures weren’t drawn, the critical results weren’t escalated. Lack of documentation with the vital signs. Lack of escalation with the temperature. When the day nurse saw the first set of critical labs there was an opportunity for the physician to really evaluate. They may have misjudged how sick he really was. On 6/13/25 at 10:36 AM a follow up interview was conducted with Staff B, DO. If they had called with the lactic acid and temperature she would have escalated. There are protocols in place that inhibit care. When she orders something, the system can auto cancel. The main concern was nursing not calling in the critical labs and the temperature. “I understand they had difficulty obtaining the vital signs because he was combative, but even the ones they got they didn’t report. If I don’t sign a form, they can cancel my blood culture orders.” Review of the facility policy, Standards of Practice, last reviewed 2/25, reflected ... Vital Signs will be completed according to policy guidelines or physician order. Nurse may implement more frequent monitoring based on their assessment of the patient’s condition. The standard of practice schedule is: Medical/Surgical: every 12 hours Review of the facility policy, Hospital Critical Values, last reviewed 2/17/25, showed ... After the licensed Caregiver receives a call communicating Critical Test Results and Values, it is the responsibility of the Licensed Caregiver to initiate contact with the Ordering Provider within 30 minutes of the receipt of a critical result from the Lab. Review of the facility policy, Identification and Management of Sepsis, dated 2/25, revealed ...All patients will be screened for possible sepsis using the [electronic health record] screening tool: ...Inpatient Units: During each shift evaluation ...When a patient screens positive for severe sepsis in the sepsis screening tool, the nurse will assess the patient and notify the charge nurse ...Upon identification of positive screen, a Sepsis Alert will be activated.”

“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: 36678 Based on review of hospital Corrective Action Plan, hospital policies, medical record review and interviews, the hospital failed to ensure the Corrective Action Plan included a plan to collect data for analysis and monitoring for one of one Corrective Action Plans reviewed. Findings included: Review of the medical record for Patient #1 reflected he came to the ED (Emergency Department) on 5/11/25 at 9:58 AM by EMS (Emergency Medical Services) for frequent falls. He had a medical history which included Parkinson’s disease (a progressive neurological disorder that primarily affects movement, causing symptoms like tremors, stiffness, and slowness of movement). He was diagnosed with a urinary tract infection (UTI) and was admitted for further workup and management of Parkinson’s, and frequent falls. In the ED, blood cultures (a laboratory test that checks for bacteria, yeast, or other microorganisms to determine if a bloodstream infection is present) were ordered by the ED Physician. There was no evidence that the blood cultures were drawn. These blood cultures were automatically cancelled after 48 hours by the electronic ordering system. Patient #1 was admitted to the medical-surgical unit, where he remained throughout his stay until his death on 5/16. The medical record showed on 5/15/25 Staff C, RN (Registered Nurse) notified Staff B, DO (Doctor of Osteopathy) by phone that Patient #1’s blood chemistry test was abnormal with a sodium level of 164 (135-145 is normal) and CO2 (carbon dioxide) less than 10. Staff B, DO ordered blood cultures again. On 5/15/25 at 5:25 PM a stat (immediate) order was entered for blood cultures. Lab comments stated the patient was “not available”, and labs were not drawn. A critical lactic acid level (5.7) (Lactic Acid is a chemical compound produced by the body when it breaks down glucose for energy in the absence of sufficient oxygen. Lactic acid levels above 7-8 mEq/L are generally associated with a fatal outcome.) was identified on 5/16 at 12:22AM and called to the nurse, but no evidence in the medical record it was reported to a physician. Lab tests drawn on 5/15 showed Patient #1’s WBCs (white blood cells) were 26.1 (normal is 4.5-11), RBC (Red Blood Cells) 6.51 (normal is 4.63-6.08), Hgb (Hemoglobin) was 19.7 (normal is 13.7-17.5) and lactic acid 3.5 (normal is 0.4-2.0). The lactic acid was reported to the on-call physician, but there was no evidence in the medical record that the physicians were notified of the white blood cell count. The last set of documented vital signs for Patient #1 was on 5/15/25 at 8:11 AM. The only vital signs documented on the night shift of 5/15/25 was a temperature at 8:08 PM of 40.1 C (104.3 F). There was no documentation that the temperature was reported to a physician. On 5/16/25 at approximately 4:00 AM Staff G, PCT (Patient Care Technician) notified Staff D, RN that Patient #1 was unresponsive, and a Code Blue (Cardiac arrest) was called. After CPR (cardiopulmonary resuscitation) was performed and several rounds of emergency medications were given, death was pronounced by the physician at 4:13AM. On 6/11/25 at 10:45 AM an interview was conducted with the VPQ (Vice President of Quality). During the interview, the VPQ disclosed that Staff D, RN didn’t follow up on critical labs, and he put the acetaminophen (fever or pain medication) on the bedside table. The VPQ said they have been hyper-focused on medication administration and critical lab results, and didn’t address the blood cultures [not being drawn]. The nurse before him reported it to the doctor. The sitter education involved a check list and CUS (concerned, uncomfortable, safety) escalation. On 6/11/25 at 12:00 PM the Quality Director was interviewed. The Quality Director said somebody looks at blood cultures every day. The sepsis coordinator reviews all sepsis alerts. He wasn’t a sepsis bundle patient because they didn’t draw a lactic (acid). The Lactic was 5.7 on 5/15/25 and the Quality Director said she saw it, but then he died. The lab draws them on the floor. The Quality Director disclosed she had heard they tried, and Patient #1 was combative. On 6/11/25 at 1:21 PM the VPQ was interviewed. The VPQ said they review blood cultures every day to see if they met the criteria. They also looked at lab documentation and a lab technician documented ‘not drawn’. An hour later another one documented ‘not available’. The patient was probably sleeping. The VPQ agreed that sleeping doesn’t make the patient unavailable. Even if the ED didn’t get it, it still comes up on the electronic system. The blood culture training was initiated (today). Lab already has started training on blood cultures. Critical values reporting is lifelong checking. Phlebotomy education was started today for pending blood cultures. During a telephone interview on 6/11/2025 at 2:14 PM Staff E, PCT (Patient Care Technician), she stated that she covered Staff G, PCT’s break for lunch around 3 AM, who was sitting with Patient #1. Staff E, PCT said she was with him for maybe 10 minutes. Patient #1 was making weird breathing sounds. But PCT, Staff G told her it was because of his Parkinson’s tremors. He seemed very short of breath. He was not on oxygen, probably because he wouldn’t keep anything on. He had tremors, like the shakes. His eyes weren’t open. The nurse came in and checked on the patient around 3:35 AM. He checked the patient’s IV (intravenous) fluids and changed the bag out, and he checked the patient. Then he left. The sitter (Staff G, PCT) came back around 3:42 AM when her break was over. A few minutes later Staff G, PCT ran out and grabbed the vital signs machine, and then a minute later the nurse came running in. A few seconds later the Code Blue alarm went off. During a telephone interview on 6/11/25 at 2:51 PM with Staff B, DO, Patient #1’s hospital physician, she disclosed that orders get auto canceled by the system if they’re not collected. There was no follow up on blood cultures. The system canceled them. Staff B, DO said she saw that the blood cultures were auto canceled, so she ordered them again. She said she thinks she ordered them routine (collected within 24 hours), the day before he passed, because he had a change of condition. Staff B, DO said he did have a positive urinalysis (UA). She doesn’t recall if the cultures grew anything. Urine cultures can take 2 to 3 days. Patient #1 got worse throughout the hospitalization. Staff B, DO disclosed she was never notified of the lactic acid results after the first one, and the on-call after hours wasn’t notified either. Staff B, DO said she consulted nephrology for the high sodium and ordered fluids and sodium bicarbonate. Staff B, DO also stated she was not notified of the elevated temperature either. Staff B, DO stated she was not notified of a change in his clinical condition. During a telephone interview on 6/11/2025 at 3:17 PM with the ED Medical Director, he said he expects that all ordered labs in the ED would be drawn. During an interview on 6/11/25 at 4:38 PM with Staff A, ED RN (Registered Nurse), she said the blood cultures shouldn’t have been missed. The ER (Emergency Room) nurse draws the blood cultures. She was not aware that they were not drawn. In a telephone interview with Staff G, PCT (Patient Care Technician) on 6/12/235 at 11:22 AM, she stated Patient #1 was fine when she came in. He was sleeping. He woke up a few times and went back to sleep. He was shaking the whole time because he has Parkinson’s. Around 3 AM he started having a change in his breathing. Staff G, PCT stated she went on break and when she returned, she noticed the change. He wasn’t shaking anymore. She said something told her something was off. Around 3:55 AM it sounded like he took his last breath. She said she went to get the vital signs machine and when she touched him, he felt cold. He wouldn’t wear a gown, so he had a blanket on. Staff G, PCT stated she couldn’t get any vital signs and so she yelled for the nurse. She told the nurse he wasn’t answering and was unresponsive. He looked like he was turning blue, and she thought he took his last breath. The nurse came in and called the patient’s name. He wasn’t moving. The nurse (Staff D, RN) pulled the Code Blue cord and started CPR. Another PCT came in and took over, and within a minute everybody was in the room taking turns. A doctor came less than a minute after everyone else. On 6/12/25 at 11:59 AM Staff D, RN was interviewed via telephone. Staff D, RN disclosed he had Patient #1 two or three times. He had Parkinson’s shaking and had slipped and fallen in the room. He was combative. Staff D, RN said he took report from the day shift when he came in that day. Staff C, RN told him the lactic acid and carbon dioxide were critical and that she called the doctor, and the doctor was aware. She said the doctor ordered fluids. An elevated lactic means acidosis. After report he saw Patient #1. He was sleeping. He hadn’t slept in 3 or 4 days. When Staff D, RN checked on him he was breathing fine. His breathing was normal at that time. The night before he took his pills by mouth, but on the day shift that day he was spitting them out. He was confused. Staff D, RN said he tried to get vitals, but Patient #1 was fighting it. He pulled the blood pressure cuff off. He was fighting, so Staff D, RN wasn’t able to get his vital signs. Staff D, RN admitted he did not notify the doctor. The technician got his temperature. He went in and rechecked it. It was high but not as high as what she charted. It was 100.6 F when he rechecked it. He didn’t save it from the blood pressure machine, so it was not documented. The parameter on the Tylenol is if it’s more than 100.5. Staff D, RN said he gave a Parkingson’s medication under Patient #1’s tongue and got called to take care of another patient. He left the Tylenol on the bedside table. He had 6 patients and there was no charge nurse that night. He doesn’t know if the lab came up to draw the cultures. Right before 4 AM, around 3:40 maybe, the sitter [Staff G, PCT] came and said the patient wasn’t breathing. Staff D, RN stated that he went in the room and saw Patient #1 was unresponsive, so he pulled the cord [to notify all staff of a cardiac arrest], and started CPR right away. Someone brought the crash cart to the bedside. CPR was performed for 20 to 25 minutes, and then the doctor called the time of death. On 6/12/25 at 1:52 PM the CMO (Chief Medical Officer) was interviewed. He stated the critical lab values weren’t called for the lactic acidosis. Patient #1 was acidotic. The care was appropriate up until the lack of reporting the critical labs. The patient was being observed by a sitter, but the communication wasn’t there. The staff were saying they were unable to take his blood pressure because he was refusing and shaking. They weren’t drawing blood cultures because of his tremors. Although the blood cultures weren’t drawn, he was on a broad-spectrum antibiotic, and so he probably would not have had a different outcome. The cultures would have been moot by then anyway because he had already received the antibiotics. There is a ‘ticket to test’ algorithm. It’s part of antibiotic stewardship. It’s a form with the criteria for a blood culture. If it doesn’t meet the criteria, then it is escalated to the supervisor. The supervisor reviews it for criteria. If the ‘ticket to test’ shows that the algorithm stops then the house supervisor or chair or he will talk to the practitioner. We try to encourage them to adhere to the criteria. It’s the discretion of the doctor. Cultures are overdrawn in the hospital, but ultimately the physician makes that decision. The hospital doesn’t cancel them. There is a list generated of unfulfilled lab orders shift to shift. The lab needs to pay more attention. On 6/12/25 at 2:30 PM an interview was conducted with Staff A, ED RN. Staff A, RN said admissions involve a ton of orders. The admitting doctor orders more. If there are new admitting orders, they go to lab. The ED nurse is still caring for the patient. They are still the ED nurse’s responsibility. The blood cultures should have been drawn here. It’s the ED’s responsibility to do ED orders, whether the patients are holding or they go to the floor. During an interview on 6/12/25 at 3:04 PM Staff H, phlebotomist stated if the patient came from ED it [lab test] is drawn right away. We don’t wait for a paper. That is the only comment they have that you can put. It’s an auto comment. It’s either ‘patient unavailable, refused, or getting transfusion’. They need to change it. ‘Patient unavailable’ could mean a lot of things. Staff H, phlebotomist said she doesn’t remember the patient. She stated she always tells the nurse if the patient is unavailable or refused. If something is pending, “I don’t let it sit.” Staff H said she has only had access to comments for a week. The lead would have put the comment in. The comment would be under her name. She hasn’t had computer access until this week. If stuff gets missed, it has to be collected. Lab doesn’t go to the ED. But if it wasn’t done, then the lab will go draw it. ‘Unavailable’ could be refused. If the patient refuses, then try to explain the reason for the lab, and if they still refuse, tell the nurse. Sometimes they can talk to the patient into it. On the form ID there have to be 3 signatures for the blood cultures; the nurse, the charge and the doctor, unless it’s a patient who just came from the ED. It can’t be drawn without their signatures. It’s a piece of paper with arrows on it. The Resident doctor can’t sign it either. The nurses on the floors know. They all have papers to fill out for blood cultures. The Lab Director was interviewed at 3:47 PM on 6/12/25. The phlebotomist, Staff H, has access in the electronic system to put comments in. But the comments are very limited. The only comment she was able to put in was ‘patient unavailable’ at the time in the electronic system. If she was waiting for permission from the nurse to draw it, then the only comment she would have entered was ‘unavailable’. “We pulled the cameras to make sure she did go to the nurse, and she did.” Usually, they ask the nurse to fill out the form to make sure it is not being collected unnecessarily. It usually has to be signed by the doctor. The ED gets blood cultures on everybody, and there was a shortage of blood culture supply bottles a few months ago. This was not flagged at all. It auto cancels after 2 days. Often times the order just wasn’t entered right. If it auto cancels, the doctor may have to put the order in again. The Lab Director said she was not aware it was an issue until they brought it to her attention, because it auto canceled. ED didn’t collect it, and she assumed they didn’t want it, but didn’t put in a cancellation. During an interview on 6/13/25 at 9:11 AM with the VPQ and the Director of Patient Safety, the VPQ stated Patient #1 was found unresponsive by the sitter. He was not doing well, and they had changed his medications. The blood cultures weren’t drawn, the critical results weren’t escalated. Lack of documentation with the vital signs. Lack of escalation with the temperature. When the day nurse saw the first set of critical labs there was an opportunity for the physician to really evaluate. They may have misjudged how sick he really was. On 6/13/25 at 10:36 AM a follow up interview was conducted with Staff B, DO. If they had called with the lactic acid and temperature she would have escalated. There are protocols in place that inhibit care. When she orders something, the system can auto cancel. The main concern was nursing not calling in the critical labs and the temperature. “I understand they had difficulty obtaining the vital signs because he was combative, but even the ones they got they didn’t report. If I don’t sign a form, they can cancel my blood culture orders. Review of the 2025 QAPI (Quality Assurance Performance Improvement) plan reflected the Quality Indicator (QI) Performance Improvement Projects (PIP) follow the process of 1) A problem is identified. 2) A project Charter is developed and submitted to the Quality Department for approval. 3) Once approved, the QI project team completes the following documents and reports out on the project quarterly during QPSC (Quality Patient Safety Committee). The documents include Measure/Indicator Development Worksheet, Goal Setting Worksheet, Measure/Indicator Collection and Monitoring Plan. QI teams may be initiated based on priorities of Regulatory or Compliance Requirements and Patient Safety. Review of the hospital corrective action plan related to an adverse event, dated 6/4/25, reflected the corrective actions as 1) Re-education on the critical [lab] result policy, 2) Education for escalating concerns for patient safety. Review of the education provided to staff members as part of the corrective action plan showed “Nursing Documentation requirements, including vital signs” and “Laboratory critical results”. Sign off sheets for Critical Lab policy, nursing documentation, 15-minute safety checks, 5 rights, and CUS (escalation of concerns) were noted. There was no education regarding drawing ordered lab tests including blood cultures. Review of the facility policy, Standards of Practice, last reviewed 2/25, reflected ... Vital Signs will be completed according to policy guidelines or physician order. Nurses may implement more frequent monitoring based on their assessment of the patient’s condition. The standard of practice schedule is: Medical/Surgical: every 12 hours Review of the facility policy, Hospital Critical Values, last reviewed 2/17/25, showed ... After the licensed Caregiver receives a call communicating Critical Test Results and Values, it is the responsibility of the Licensed Caregiver to initiate contact with the Ordering Provider within 30 minutes of the receipt of a critical result from the Lab. Review of the facility policy, Identification and Management of Sepsis, dated 2/25, revealed ...All patients will be screened for possible sepsis using the Meditech screening tool: ...Inpatient Units: During each shift evaluation ...When a patient screens positive for severe sepsis in the sepsis screening tool, the nurse will assess the patient and notify the charge nurse ...Upon identification of positive screen, a Sepsis Alert will be activated.”

“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: 36678 Based on policy review, medical record review, and interviews, the hospital failed to ensure that nursing staff followed the policies and procedures of the hospital and failed to ensure that there was supervision of nursing staff to provide appropriate and timely care of one patient (#1) of five sampled. Findings included: Review of the facility policy, Identification and Management of Sepsis, dated 2/25, revealed ...All patients will be screened for possible sepsis using the [electronic health record] screening tool ...Inpatient Units: During each shift evaluation ...When a patient screens positive for severe sepsis in the sepsis screening tool, the nurse will assess the patient and notify the charge nurse ...Upon identification of positive screen, a Sepsis Alert will be activated. Review of the facility policy, Standards of Practice, last reviewed 2/25, reflected ... Vital Signs will be completed according to policy guidelines or physician order. Nurses may implement more frequent monitoring based on their assessment of the patient’s condition. The standard of practice schedule is: Medical/Surgical: every 12 hours Review of the facility policy, Hospital Critical Values, last reviewed 2/17/25, showed ... After the licensed Caregiver receives a call communicating Critical Test Results and Values, it is the responsibility of the Licensed Caregiver to initiate contact with the Ordering Provider within 30 minutes of the receipt of a critical result from the Lab. Review of the medical record for Patient #1 reflected he came to the ED (Emergency Department) on 5/11/25 at 9:58 AM by EMS (Emergency Medical Services) for frequent falls. He had a medical history which included Parkinson’s disease (a progressive neurological disorder that primarily affects movement, causing symptoms like tremors, stiffness, and slowness of movement). He was diagnosed with a urinary tract infection (UTI) and was admitted for further workup and management of Parkinson’s, and frequent falls. In the ED, blood cultures (a laboratory test that checks for bacteria, yeast, or other microorganisms to determine if a bloodstream infection is present) were ordered by the ED Physician. There was no evidence that the blood cultures were drawn. These blood cultures were automatically canceled after 48 hours by the electronic ordering system. Patient #1 was admitted to the medical-surgical unit, where he remained throughout his stay until his death on 5/16. The medical record showed on 5/15/25 Staff C, RN (Registered Nurse) notified Staff B, DO (Doctor of Osteopathy) by phone that Patient #1’s blood chemistry test was abnormal with a sodium level of 164 (135-145 is normal) and CO2 (carbon dioxide) less than 10. Staff B, DO ordered blood cultures again. On 5/15/25 at 5:25 PM a stat (immediate) order was entered for blood cultures. Lab comments stated the patient was “not available”, and labs were not drawn. A critical lactic acid level (5.7) (Lactic Acid is a chemical compound produced by the body when it breaks down glucose for energy in the absence of sufficient oxygen. Lactic acid levels above 7-8 mEq/L are generally associated with a fatal outcome.) was identified on 5/16 at 12:22 AM and called to the nurse, but no evidence in the medical record it was reported to a physician. Lab tests drawn on 5/15 showed Patient #1’s WBCs (white blood cells) were 26.1 (normal is 4.5-11), RBC (Red Blood Cells) 6.51 (normal is 4.63-6.08), Hgb (Hemoglobin) was 19.7 (normal is 13.7-17.5) and lactic acid 3.5 (normal is 0.4-2.0). The lactic acid was reported to the on-call physician, but there was no evidence in the medical record that the physicians were notified of the white blood cell count. The last set of documented vital signs for Patient #1 was on 5/15/25 at 8:11 AM. The only vital signs documented on the night shift of 5/15/25 was a temperature at 8:08 PM of 40.1 C (104.3 F). There was no documentation that the temperature was reported to a physician. On 5/16/25 at approximately 4:00 AM Staff G, PCT (Patient Care Technician) notified Staff D, RN that Patient #1 was unresponsive, and a Code Blue (Cardiac arrest) was called. After CPR (cardiopulmonary resuscitation) was performed and several rounds of emergency medications were given, death was pronounced by the physician at 4:13 AM. During a telephone interview on 6/11/2025 at 2:14 PM Staff E, PCT (Patient Care Technician), she stated that she covered Staff G, PCT’s break for lunch around 3 AM, who was sitting with Patient #1. Staff E, PCT said she was with him for maybe 10 minutes. Patient #1 was making weird breathing sounds. But PCT, Staff G told her it was because of his Parkinson’s tremors. He seemed very short of breath. He was not on oxygen, probably because he wouldn’t keep anything on. He had tremors, like the shakes. His eyes weren’t open. The nurse came in and checked on the patient around 3:35 AM. He checked the patient’s IV (intravenous) fluids and changed the bag out, and he checked the patient. Then he left. The sitter (Staff G, PCT) came back around 3:42 AM when her break was over. A few minutes later Staff G, PCT ran out and grabbed the vital signs machine, and then a minute later the nurse came running in. A few seconds later the Code Blue alarm went off. During a telephone interview on 6/11/25 at 2:51 PM with Staff B, DO, Patient #1’s hospital physician, she disclosed that orders get auto canceled by the system if they’re not collected. There was no follow up on blood cultures. The system canceled them. Staff B, DO said she saw that the blood cultures were auto canceled, so she ordered them again. She said she thinks she ordered them routine (collected within 24 hours), the day before he passed, because he had a change of condition. Staff B, DO said he did have a positive urinalysis (UA). She doesn’t recall if the cultures grew anything. Urine cultures can take 2 to 3 days. Patient #1 got worse throughout the hospitalization. Staff B, DO disclosed she was never notified of the lactic acid results after the first one, and the on-call after hours wasn’t notified either. Staff B, DO said she consulted nephrology for the high sodium and ordered fluids and sodium bicarbonate. Staff B, DO also stated she was not notified of the elevated temperature either. Staff B, DO stated she was not notified of a change in his clinical condition. During an interview on 6/12/25 at 10:12 AM, Staff C, RN, said she cared for Patient #1 only once, on the day before he passed. She told Staff B, DO about the sodium and another physician who was on-call, about the lactic acid. Staff B, DO consulted nephrology. Staff B, DO spoke to the Nephrologist on the phone and ordered start D5 (Dextrose 5%) intravenously (IV) and sodium bicarbonate (a medication to treat severe metabolic acidosis). Staff B, DO put the orders in for the IV fluids the Nephrologist wanted. Staff C, RN said she got report from Staff D, RN. Patient #1 was diaphoretic (perspiring/sweating), shaking and non-verbal, but awake and confused. He had a sitter and was on the camera monitor. His vital signs were normal. He was not on a heart monitor, so the vital signs are done every shift. He was mouth breathing. Staff B, DO saw him around 8 or 9 AM and his family was at the bedside. Staff B, DO rounded again in the afternoon. Neurology was seeing him and changed his Parkinson’s medications, because he wasn’t able to swallow. He made his medications sublingual (dissolvable under the tongue) and IV (intravenous). He had oral Tylenol ordered. His doctors saw him. They said it was because he hadn’t had his Parkinson’s medications. The plan was to switch his medications and monitor him. It was late on her shift when the lab results came. He got a Foley (urinary catheter) for strict I and O (intake and output). The interventions were implemented. There is no charge on nights shift. The night charge has been out on leave for months. There isn’t another charge on nights. She didn’t come in until 7 AM because she wasn’t aware she would be in charge, so she didn’t get report from the night nurses. During an interview on 6/12/25 at 10:36 AM the Director of 3 South stated the charge called off yesterday and today. The nurse manager runs the reports and rounds and talks to all the nurses. She just got out of multidisciplinary rounds so she hasn’t rounded with the nurses yet. We shift resources during the day. We have [electronic chat] communication. There is huddle at 7. Night shift reports safety issues. In a telephone interview with Staff G, PCT (Patient Care Technician) on 6/12/235 at 11:22 AM, she stated Patient #1 was fine when she came in. He was sleeping. He woke up a few times and went back to sleep. He was shaking the whole time because he has Parkinson’s. Around 3 AM he started having a change in his breathing. Staff G, PCT stated she went on break and when she returned, she noticed the change. He wasn’t shaking anymore. She said something told her something was off. Around 3:55 AM it sounded like he took his last breath. She said she went to get the vital signs machine and when she touched him, he felt cold. He wouldn’t wear a gown, so he had a blanket on. Staff G, PCT stated she couldn’t get any vital signs and so she yelled for the nurse. She told the nurse he wasn’t answering and was unresponsive. He looked like he was turning blue, and she thought he took his last breath. The nurse came in and called the patient’s name. He wasn’t moving. The nurse (Staff D, RN) pulled the Code Blue cord and started CPR. Another PCT came in and took over, and within a minute everybody was in the room taking turns. A doctor came less than a minute after everyone else. On 6/12/25 at 11:59 AM Staff D, RN was interviewed via telephone. Staff D, RN disclosed he had Patient #1 two or three times. He had Parkinson’s shaking and had slipped and fallen in the room. He was combative. Staff D, RN said he took report from the day shift when he came in that day. Staff C, RN told him the lactic acid and carbon dioxide were critical and that she called the doctor, and the doctor was aware. She said the doctor ordered fluids. An elevated lactic means acidosis. After report he saw Patient #1. He was sleeping. He hadn’t slept in 3 or 4 days. When Staff D, RN checked on him he was breathing fine. His breathing was normal at that time. The night before he took his pills by mouth, but on the day shift that day he was spitting them out. He was confused. Staff D, RN said he tried to get vitals but Patient #1 was fighting it. He pulled the blood pressure cuff off. He was fighting, so Staff D, RN wasn’t able to get his vital signs. Staff D, RN admitted he did not notify the doctor. The technician got his temperature. He went in and rechecked it. It was high but not as high as what she charted. It was 100.6 F when he rechecked it. He didn’t save it from the blood pressure machine, so it was not documented. The parameter on the Tylenol is if it’s more than 100.5. Staff D, RN said he gave a Parkinson’s medication under Patient #1’s tongue and got called to take care of another patient. He left the Tylenol on the bedside table. He had 6 patients and there was no charge nurse that night. He doesn’t know if the lab came up to draw the cultures. Right before 4 AM, around 3:40 maybe, the sitter [Staff G, PCT] came and said the patient wasn’t breathing. Staff D, RN stated that he went in the room and saw Patient #1 was unresponsive, so he pulled the cord [to notify all staff of a cardiac arrest], and started CPR right away. Someone brought the crash cart to the bedside. CPR was performed for 20 to 25 minutes, and then the doctor called the time of death. In an interview with the VPQ (Vice President of Quality) on 6/12/25 at 12:10 PM she stated she asked Staff D, RN if he understood the policy [Standard of Care] and he said he did. He was very honest. He said the patient was sleeping and he didn’t want to wake him up. I asked him again if he understood the policy. He said he did. On 6/12/25 at 1:52 PM the Chief Medical Officer (CMO) was interviewed. Regarding Patient #1, he said he was not sure why the antibiotics were started. They ordered blood cultures. He was shaking a lot, and they couldn’t get the blood cultures. He was on a broad-spectrum antibiotic. He really seemed to take a turn on the last day. He may have developed an infection around the 12th, but he was on already on Rocephin. The critical lab values weren’t called for the lactic acidosis. He was acidotic. The care was appropriate up until the lack of reporting the critical labs. The patient was being observed by a sitter, but the communication wasn’t there. The staff were saying they were unable to take his blood pressure because he was refusing and shaking. They weren’t drawing blood cultures because of his tremors. Even if he was transferred to a higher level of care, the care would have been the same. Although the blood cultures weren’t drawn, he was on a broad-spectrum antibiotic, and so he probably would not have had a different outcome. The cultures would have been moot by then anyway because he had already received the antibiotics. During an interview on 6/13/25 at 9:11 AM with the VPQ and the Director of Patient Safety, the VPQ stated Patient #1 was found unresponsive by the sitter. He was not doing well, and they had changed his medications. The blood cultures weren’t drawn, the critical results weren’t escalated. Lack of documentation with the vital signs. Lack of escalation with the temperature. When the day nurse saw the first set of critical labs there was an opportunity for the physician to really evaluate. They may have misjudged how sick he really was. On 6/13/25 at 10:36 AM a follow up interview was conducted with Staff B, DO. If they had called with the lactic acid and temperature she would have escalated. There are protocols in place that inhibit care. When she orders something the system can auto-cancel. The main concern was them not calling in the critical labs and the temperature. “I understand they had difficulty obtaining the vital signs because he was combative, but even the ones they got they didn’t report. If I don’t sign a form, they can cancel my blood culture orders.””

“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: 48190 Based on review of video footage, EMS (Emergency Medical Services) report, medical record, electronic central log, facility policy, and interviews, it was determined the facility failed to 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 for 1 (Patient #1) of 20 patients reviewed Findings included: Cross Refer to A-2406.”

“EMERGENCY ROOM LOG CFR(s): 489.20(r)(3) [The provider agrees,] in the case of a hospital as defined in §489.24(b) (including both the transferring and receiving hospitals), to maintain a central log on each individual who comes to the emergency department, as defined in §489.24(b), seeking assistance and whether he or she refused treatment, was refused treatment, or whether he or she was transferred, admitted and treated, stabilized and transferred, or discharged. §489.24 The provisions of this regulation apply to all hospitals that participate in Medicare and provide emergency services. This Standard is not met as evidenced by: 48190 Based on review of video footage, EMS (Emergency Medical Services) report, electronic central log, medical record, facility policy, and interviews, it was determined the facility failed to maintain a central log on each individual who comes to the emergency department, seeking assistance and whether he or she refused treatment, was refused treatment, or whether he or she was transferred, admitted and treated for 1 (Patient #1) of 20 patients reviewed. Findings Included: Review of video footage revealed: 00:38 EMS is seen taking Patient #1 inside facility. 2:32 EMS is seen taking Patient #1 out the facility. 2:55 Patient #1 seen moving arms and speaking to EMS. 3:40 security outside with EMS and Patient #1. 5:37 CNC (Clinical Charge Nurse) comes outside speaking with EMS and security while Patient #1 appears to be agitated. 7:20 CNC goes back inside facility. 8:00 Patient #1 seemed extremely agitated while talking to EMS. 9:13 Female EMS (EMS supervisor) on scene speaking to Patient #1 and EMS; Patient #1 appears to be yelling and agitated. 10:41 Patient #1 agitated and trying to get off stretcher while it appears to be yelling at EMS and security. 12:25 Patient #1 throwing himself around on the stretcher. 13:26 EMS Supervisor enters facility while Patient #1 still appears to be yelling and agitated on stretcher. 14:53 EMS Supervisor walks back out of the facility. 18:41 EMS raises Patient #1 stretcher and rolls Patient #1 away from facility. Review of the EMS (Emergency Medical Services) report dated 03/05/2025 at 9:00 PM revealed arrived-on scene to find Patient #1 pacing outside the police department. Patient #1 states he is suicidal, homicidal and is scared for his life; he believes people are trying to kill him. Patient #1 was extremely paranoid and uncooperative. Patient #1 then agrees to go to hospital. Arrived at the hospital, the hospital immediately informed EMS the patient could not be there as he has been trespassed from that hospital. According to the staff, they are not even going to register the patient unless it is a true medical emergency. Patient #1 then transported to [another hospital]. Review of the electronic central log for 03/05/2025 revealed no entry for Patient #1. No facility medical record was available to review for Patient #1. Review of facility policy “EMTALA- Central Log Policy” last revised 08/2024 states “The hospital will maintain a central log containing information on each individual who requests emergency services or care or whose appearance or behavior would cause a prudent layperson observer to believe the individual needed examination or treatment, whether he or she left before a medical screening examination could be performed, whether he or she refused treatment, whether he or she was refused treatment, or whether he where she was transferred, admitted and treated, stabilized and transferred or discharged.” During an interview on 03/25/2025 10:15 AM, the ED (Emergency Department) Medical Director stated when I found out the ED MD (Medical Doctor) assessed the patient and he was never registered, I knew it was an EMTALA. During an interview on 03/25/2025 at 11:45 AM, the ED MD stated I went outside to do quick assessment and make sure the patient did not have a medical emergency, then came back inside. I went to see other patients. The ED charge RN (registered Nurse) told me the house supervisor called and said no do not register the patient. So, he was not registered. During an interview on 04/01/2025 at 6:00 PM, the CNC (Clinical Charge Nurse) stated I was made aware the patient coming in had been trespassed from our facility. So, I called the house supervisor for advice on what to do. She told me to only register the patient if he has a medical emergency. When the patient got here, the MD went outside to do a quick assessment on the patient and the MD said he is fine. So, I went outside to tell EMS he is cleared by the ER MD. EMS said they will have to call their chief (supervisor). The chief comes in and tells EMS to take the patient to another hospital since we will not register him here because he is trespassed. I did not get a full report from EMS so I do not know if his vitals were stable or abnormal. I just went by MD’s quick assessment. Then they left.”

“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: 48190 Based on review of video footage, EMS (Emergency Medical Services) report, electronic central log, medical record, facility policy, and interviews, it was determined the facility failed to 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 for 1 (Patient #1) of 20 patients reviewed. Findings Included: Review of video footage revealed: 00:38 EMS is seen taking Patient #1 inside facility. 2:32 EMS is seen taking Patient #1 out the facility. 2:55 Patient #1 seen moving arms and speaking to EMS. 3:40 security outside with EMS and Patient #1. 5:37 CNC (Clinical Charge Nurse) comes outside speaking with EMS and security while Patient #1 appears to be agitated. 7:20 CNC goes back inside facility. 8:00 Patient #1 seen extremely agitated while talking to EMS. 9:13 Female EMS (EMS supervisor) on scene speaking to Patient #1 and EMS; Patient #1 appears to be yelling and agitated. 10:41 Patient #1 agitated and trying to get off stretcher while it appears to be yelling at EMS and security. 12:25 Patient #1 throwing himself around on the stretcher. 13:26 EMS Supervisor enters facility while Patient #1 still appears to be yelling and agitated on stretcher. 14:53 EMS Supervisor walks back out the facility. 18:41 EMS raises Patient #1 stretcher and rolls Patient #1 away from facility. Review of the EMS (Emergency Medical Services) report dated 03/05/2025 at 9:00 PM revealed arrived-on scene to find Patient #1 pacing outside the [police department]. Patient #1 states he is suicidal, homicidal and is scared for his life; he believes people are trying to kill him. Patient #1 was extremely paranoid and uncooperative. Patient #1 then agrees to go to hospital. Arrived at the hospital, the hospital immediately informed the patient could not be there as he has been trespassed from that hospital. According to the staff, they are not even going to register the patient unless it is a true medical emergency. Patient #1 then transported to [another hospital]. Review of the electronic central log for 03/05/2025 revealed no entry for Patient #1. No facility medical record was available to review for Patient #1. Review of medical record from [Hospital where EMS took patient after refusal to evaluate] revealed Patient #1 is a 55yr old male with a history of methamphetamine and alcohol abuse, presents to the ER by EMS with complaints of suicidal and homicidal ideations. On arrival he is intoxicated and requires [medication name] and [medication name] with improvement; patient is less agitated. His vital signs are stable, he has no additional complaints, and he is stable for transfer to psychiatric facility under a Baker Act (a state law in Florida that allows for the involuntary hospitalization of individuals who are experiencing a mental health crisis and pose a serious threat to themselves or others). Review of facility policy EMTALA (Emergency Medical Treatment and Labor Act) - Medical Screening Examination and Stabilization last reviewed 08/2024. The policy revealed “An EMTALA obligation is triggered when: an individual or a representative acting on the individual’s behalf, including EMS or a transferring hospital, request emergency services and care .....When a MSE (Medical Screening Examination ) is required” A hospital must provide an appropriate MSE within the capability of the hospital’s emergency department, including ancillary services routinely available to the DED (Dedicated Emergency Department), to determine whether or not an EMC (Emergency Medical Condition) exists: (i) to any individual, ...who requests an examination; (ii) an individual who has such a request made on his or her behalf; or (iii) an individual whom a prudent layperson observer would conclude from the individuals appearance or behavior needs an MSE.” During an interview on 03/25/2025 at 10:15 AM, the ED (Emergency Department) Medical Director stated I found out the ED MD assessed the patient and did not document because he was never registered, I knew it was an EMTALA. During an interview on 03/25/2025 at 11:45 AM, the ED MD (Medical Doctor) stated I went outside to do quick assessment and make sure the patient did not have a medical emergency, then came back inside. I went to see other patients. Then, the charge nurse said the house supervisor called and said no do not register the patient. So, he was not registered. I did see the patient to make sure there was no medical condition, but I did not document anything because he was not registered. During an interview on 04/01/2025 at 6:00 PM, the CNC (Clinical Charge Nurse) stated I was made aware the patient coming in had been trespassed from our facility. So, I called the house supervisor for advice on what to do. She told me to only register the patient if he has a medical emergency. When the patient got here, the MD went outside to do a quick assessment on the patient and the MD said he is fine. So, I went outside to tell EMS he is cleared by the ER MD. EMS said they will have to call their chief (supervisor). The chief comes in and tells EMS to take the patient to another hospital since we will not register him here because he is trespassed. I did not get a full report from EMS so I do not know if his vitals were stable or abnormal. I just went by MD’s quick assessment. Then they left. The facility failed to ensure that their policy and procedure was followed as evidenced by failing to ensure that when a request was made on Patient #1’s behalf by EMS for an evaluation because it was determined due to the patient’s behavior he needed a medical screening exam. The facility failed to provide an appropriate MSE for Patient #1 on 03/05/2025 that was within the capability if the hospital’s emergency department, including ancillary services routinely available to the emergency to determine whether or not an emergency medical condition existed, as stated in the facility’s policy.”