Winter Haven Hospital

“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 facility policy, medical record review, video footage, and interviews, the facility failed to conduct a thorough emergency medical screening to include cardiac monitoring and troponin (blood test measures the levels of cardiac-specific proteins [I or T] in the blood, which are released when the heart muscle is damaged, primarily to diagnose heart attacks)measurements to rule out an acute cardiac event, and did not perform a d-dimer (blood test measures fibrin degradation products, which are protein fragments released when a blood clot dissolves in the body) or CTA (Computed Tomography Angiography) of the chest to rule out possible pulmonary embolus (a sudden, life-threatening blockage in one of the pulmonary arteries in the lungs, typically caused by a blood clot traveling from the legs or pelvis ) for 1 (Patient #13) of 21 patients reviewed. Findings included: Review of policy “Emergency Medical Treatment and Active Labor Act” last reviewed 09/2025 states “Any individual who comes to the hospital campus requesting examination or treatment for a medical condition must be provided with an appropriate medical screening examination to determine if he/she is suffering from an emergency medical condition. If an emergency medical condition is determined to exist, the hospital provides treatment, including ancillary services routinely available in the emergency department, until the individual is stable or transferred to another hospital that can provide the necessary care.” Review of Patient #13’s medical record revealed on 3/9/2026 patient entered the ED (emergency department) at 8:46 PM and checked in with a chief complaint of sudden onset of shortness of breath, chest pain, nausea for 1 hour. At 8:48 PM STAT (immediately or without delay) orders for CBC (complete blood count- common blood test used to evaluate overall health, detect infections, anemia, leukemia, or monitor health conditions like chronic kidney disease), chest pain power plan, CMP (Comprehensive Metabolic Panel [CMP] is a 14-test blood panel that measures sugar, electrolyte levels, kidney function, and liver function to assess overall metabolic health), chest xray, EKG (An electrocardiogram [EKG] is a noninvasive, 10-15 minute procedure that records the electrical activity of the heart using electrodes attached to the chest, arms, and legs), and troponin (blood test measures the levels of cardiac-specific proteins [I or T] in the blood, which are released when the heart muscle is damaged, primarily to diagnose heart attacks) was entered into the computer. At 8:57 PM, the vital signs were obtained; blood pressure 172/122, heart rate 114 and 10/10 pain level and an ESI of 2 (Emergency Severity Index (ESI) is a five-level, rapid triage algorithm used in emergency departments to classify patients based on acuity (severity) and expected resource needs. Level 1 (Resuscitation): Immediate life-saving intervention needed (e.g., cardiac arrest, intubation). Level 2 (Emergent): High-risk situation, confused/lethargic, or severe pain/distress. The MSE (medical screen evaluation) was initiated and an EKG was performed. At 8:51 PM, the EKG revealed sinus tachycardia (heart rate >100) inferior infarct (inferior myocardial infarction (MI) often indicates a high-stress state, pain, or compensatory response to reduced cardiac output. Inferior MIs with sinus tachycardia suggests a more complex, potentially serious, or compensatory, and requires urgent management to optimize cardiac function.) The medical provider ordered to repeat the EKG in 15 minutes. At 9:00 PM, the repeat EKG revealed sinus tachycardia without inferior infarct. At 11:05 PM, nursing note revealed “no answer after being called several times. Unable to locate patient or to discuss risks and benefits of leaving. Presume he left.” All lab orders were canceled with a reason that states “patient discharged”. Review of video footage revealed: 3/09/2026 8:45 PM- Patient and wife walking in; patient noted with hand on chest 8:46 PM- Patient and wife at registration desk then noted walking into triage area 8:48 PM- patient noted getting in wheelchair and tech pushing patient into the main ED 8:53 PM- tech pushing patient in wheelchair back out to lobby then again into triage. Patient still noted with hand over chest. 8:57 PM- tech pushing Patient in wheelchair back out to lobby 8:59 PM- Patient in wheelchair sitting next to wife in lobby. Patient and wife sitting directly across from triage lead RN (registered nurse) desk. 9:00 PM- Patient sitting in wheelchair with hand over chest, wiping his head, and shaking his right arm. 9:06 PM- wife noted at desk with registration then sent back to sit next to patient 9:22 PM- wife noted at desk talking with triage lead 9:25 PM- patient seen pushed in wheelchair back to main ED 9:28 PM- patient noted back in lobby sitting next to wife with his hand over his chest and shaking his right arm 9:59 PM- PCT (patient care technician) noted taking patients vital signs 10:04 PM- wife noted at desk with registration again 10:36 PM- wife noted at desk talking with triage lead 10:38 PM- wife and patient seen walking out During an interview on 04/07/2026 at 11:20 AM, the ED Medical Director stated if a patient checks in with symptomatic chest pain then the expectation is for the patient to be brought back as soon as possible for workup. Workup includes EKG, labs, chest xray. During an interview on 04/07/2026 at 11:35 AM, the ED Manager stated if a patient is in the lobby and there is report to the triage RN the patients’ symptoms are getting worse, the expectation the patient is to be reassessed as soon as possible. During an interview on 04/07/2026 at 3:08 PM, the ED Provider stated I looked at the EKG and believed there were subtle changes in the leads and looked abnormal. Per protocol I had nursing repeat in 15 minutes. It was repeated and I compared it to the original and saw it looked better. I was not aware the vital signs were abnormal too and the labs were not drawn. The nurse practitioner did the MSE not myself, I did not lay eyes on the patient at all. During an interview on 04/08/2026 at 10:42 AM, the Nurse Practitioner stated if a patient comes in with chest pain and abnormal vital signs, I expect all orders to be carried out as ordered; STAT. I also expect to be made aware if the retake of vital signs are still abnormal and I also expect if a patient checks in with chest pain, the chest pain level to be rechecked the same time vital signs are taken. An ESI of 2 should be prioritized and not left in the lobby for 3 hours. Review of Patient #13’s medical record from [second hospital name Patient #13 presented at seeking treatment], the history and physical documented by the MD revealed, 51 yr old male with a past medical history of high blood pressure.... On 3/8/2026 patient presented to the ED with a sudden onset of chest pain that started approximately 7PM this evening 10/10 on pain scale sharp in nature it would ease off and come back so he came to the ED for evaluation. Patient did not take medications at home for his symptoms. Patient did however attempt to go to [Winter Haven Hospital] to be seen, however, patient had been waiting for 5 hours and not been seen yet so he decided to leave and come here. Patient’s blood pressure on arrival 172/122, repeat 145/105. EKG in ED showed normal sinus rhythm (healthy rhythm) with inferior infarct. Troponin (a protein found in heart muscle cells that is released into the bloodstream when the heart is damaged) lab draw 718 (normal <14). Patient admitted for NSTEMI (A Non-ST-segment Elevation Myocardial Infarction is a heart attack caused by a partial blockage of a coronary artery, reducing blood flow and damaging the heart muscle). On 3/10/2026 Patient #13 underwent a cardiac catheterization and received a stent in an artery. Again on 3/12/2026, patient underwent another cardiac catheterization and received another stent in a different artery. Patient was stabilized and discharged home on 3/13/2026.”

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 42154 Based on the facility medication guide, medical record reviews and interviews, the facility failed to uphold patients right to timely emergent care by failing to provide life sustaining medication in one (# 1) of two isoproterenol cardiac medication patients reviewed. Refer to A0144 Patient Rights: Care in a Safe Setting, CFR 482.13. The facility provided an Immediate Jeopardy removal plan on 12/17/2025. The immediacy was determined to be removed 11:29 AM on 12/17/2025. The actions included: Review of Life-Sustaining Cardiac Medications and Availability; a team of hospital leadership, nursing leaders, pharmacy staff, and quality improvement staff gathered to review a list of any potential life-sustaining cardiac medications which, if they run dry, would result in cardiac arrest. The following two medications need to be mixed by pharmacy and are not kept stocked in the Critical Care and Emergency Departments: Isoproterenol (Isuprel) and Vasopressin. The process for ordering and restocking Vasopressin is as follows: Vasopressin drip is a non-titratable drip (an intravenous (IV) medication infusion administered at a fixed, ordered rate that generally cannot be adjusted by a nurse without a new physician’s order), therefore once ordered, a duration of 22.22 hours per each bag is calculated by the charting system based on the rate. Subsequent bags print on the batch every shift (3 shifts per day), and are made and delivered to the refrigerated patient specific bin at least 4 hours before the next bag is needed. Vasopressin is a non-titratable (drug which runs for approximately 22.22 hours per bag. The system currently in place for the re-ordering and re-compounding of Vasopressin allows for ready stock of medication to be on hand. Isoproterenol (Isuprel) is a titratable drip, and therefore Pharmacy cannot predict when a new bag will be needed. It takes approximately 1 hour lead time for pharmacy to compound. There is a sign-off sheet for an every-shift to sign off ensuring the secondary Isuprel drip is present and in date. Audits of presence of secondary Isuprel drips will be conducted by pharmacy staff or leaders on a daily basis for 30 days, weekly for 4 weeks, monthly for 1 month, then quarterly times 3. Fallouts of timely notification will be documented in the event reporting system and escalated to leadership through daily huddle and weekly First Focus reviews. Results will be reported to: Quality Council meeting monthly x 3 meetings then quarterly x 3 meetings (or ongoing if issues arise) and Board Clinical Excellence Committee. TheraDoc is a clinical surveillance and decision support software system used in hospitals to improve patient safety by providing real-time alerts for potential adverse drug events and other clinical risks. Pharmacy will add alerts to any Isuprel order which will notify pharmacists when this medication is ordered stating: “Confirm that there is currently a stocked isoproterenol drip available in the pharmacy. Document verification daily in the patient flag”. An urgent safety alert regarding Isuprel and Vasopressin was created to distribute to all nursing staff in Critical Care and ED (emergency room) areas. This safety alert emphasizes the importance of timely requesting these medications from pharmacy, and the inclusion of the charge nurse for drip initiation and with each new bag. Nursing developed and implemented an Isuprel Hand-Off/Audit tool (see attached in Appendix) to ensure that timely notification to pharmacy occurs with Isuprel drips. Audits of timely notification of Isuprel drips will be conducted by unit charge nurses or leaders on a daily basis for 30 days, weekly for 4 weeks, monthly for 1 month, then quarterly times 3. · Fallouts of timely notification will be documented in the PRISM event reporting system and escalated to leadership through daily huddle and weekly First Focus reviews. · Results will be reported to: · Quality Council meeting monthly x 3 meetings then quarterly x 3 meetings (or ongoing if issues arise) · Board Clinical Excellence Committee meetings x 3 meetings (or ongoing if issues arise)”

“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: 42154 Based on medical record review, staff interviews and facility documents, the facility failed to ensure the nursing staff provided 1 (Patient #1) of 2 patients the life sustaining cardiac infusion (isoproterenol) as ordered. The lack of attention to the medication resulted in the patient requiring resuscitation. Refer to A0398 The facility provided an Immediate Jeopardy removal plan on 12/17/2025. The immediacy was determined to be removed 11:29 AM on 12/17/2025. The actions included: Review of Life-Sustaining Cardiac Medications and Availability; a team of hospital leadership, nursing leaders, pharmacy staff, and quality improvement staff gathered to review a list of any potential life-sustaining cardiac medications which, if they run dry, would result in cardiac arrest. The following two medications need to be mixed by pharmacy and are not kept stocked in the Critical Care and Emergency Departments: Isoproterenol (Isuprel) and Vasopressin. The process for ordering and restocking Vasopressin is as follows: Vasopressin drip is a non-titratable drip (an intravenous (IV) medication infusion administered at a fixed, ordered rate that generally cannot be adjusted by a nurse without a new physician’s order) therefore once ordered, a duration of 22.22 hours per each bag is calculated by the system. Subsequent bags print on the batch every shift (3 shifts per day), and are made and delivered to the refrigerated patient specific bin at least 4 hours before the next bag is needed. Vasopressin is a non-titratable drug which runs for approximately 22.22 hours per bag. The system currently in place for the re-ordering and re-compounding of Vasopressin allows for ready stock of medication to be on hand. Isoproterenol (Isuprel) is a titratable drip (an intravenous (IV) infusion of medication where the dosage rate is continuously adjusted by a healthcare professional (usually a nurse) to achieve a specific, desired physiological effect or target in the patient, such as a target blood pressure, heart rate, pain level, or sedation level), and therefore Pharmacy cannot predict when a new bag will be needed. It takes approximately 1 hour lead time for pharmacy to compound. There is a sign-off sheet for an every-shift sign off ensuring the secondary Isuprel drip is present and in date. Audits of presence of secondary Isuprel drips will be conducted by pharmacy staff or leaders on a daily basis for 30 days, weekly for 4 weeks, monthly for 1 month, then quarterly times 3. Fallouts of timely notification will be documented in the PRISM event reporting system and escalated to leadership through daily huddle and weekly First Focus reviews. Results will be reported to: Quality Council meeting monthly x 3 meetings then quarterly x 3 meetings (or ongoing if issues arise) and Board Clinical Excellence Committee. TheraDoc is a clinical surveillance and decision support software system used in hospitals to improve patient safety by providing real-time alerts for potential adverse drug events and other clinical risks. Pharmacy will add alerts to any Isuprel order which will notify pharmacists when this medication is ordered stating: “Confirm that there is currently a stocked isoproterenol drip available in the pharmacy. Document verification daily in the patient flag”. An urgent safety alert regarding Isuprel and Vasopressin was created to distribute to all nursing staff in Critical Care and ED (emergency department) areas. This safety alert emphasizes the importance of timely requesting these medications from pharmacy, and the inclusion of the charge nurse for drip initiation and with each new bag. Nursing developed and implemented an Isuprel Hand-Off/Audit tool to ensure that timely notification to pharmacy occurs with Isuprel drips. Audits of timely notification of Isuprel drips will be conducted by unit charge nurses or leaders on a daily basis for 30 days, weekly for 4 weeks, monthly for 1 month, then quarterly times 3. · Fallouts of timely notification will be documented in the event reporting system and escalated to leadership through daily huddle and weekly First Focus reviews. · Results will be reported to: · Quality Council meeting monthly x 3 meetings then quarterly x 3 meetings (or ongoing if issues arise) · Board Clinical Excellence Committee meetings x 3 meetings (or ongoing if issues arise)”

“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: 42154 Based on medical record review, interviews, and the medication information guide, the facility failed to provide care in a safe setting by failing to maintain the continuous life-sustaining intravenous medication,isoproterenol, in 1 (Patient #1) of 2 patients. This failure resulted in Patient #1 heart to stop and require resuscitation. The patient subsequently expired on 11/23/2025. Findings included: Review of the medical record for Patient #1 revealed on 11/16/2025 at 6:54 AM he arrived to the emergency department by Emergency Medical Services (EMS) with his heart rate in the 30’s (normal is 60-100). He was found to have 2nd degree Mobitz type 1 heart block (condition where electrical signals from the atria to the ventricles slows down causing low heart rate). Patient #1 was placed on an isoproterenol (potent medication used primarily to treat certain serious heart conditions and shock) drip IV (intravenous) to titrate (continuously measure and adjust the balance according to the response). On 11/16/2025 at 7:51 AM the isoproterenol started at 30 milliliter (ml)/ hour (hr) in the emergency department to maintain the heart rate between 50-70. The last documented isoproterenol IV drip was hung on 11/17/2025 at 6:10 AM, running at a rate of 105 ml/ hour with the bag volume of 250 ml. On 11/17/2025 at 9:16 AM Patient #1 went into cardiac arrest (heart stops electrical and mechanical activity). On 11/18/2025 at 9:09 AM the physician progress note revealed the “patient suffered brief asystole cardiac arrest requiring CPR [cardiopulmonary resuscitation] as there was 50 minutes delay to restart isoproterenol. He required mechanical ventilation.” Patient #1 expired on 11/23/2025. During an interview on 12/15/2025 at 11:00 AM, Staff D, Quality Manager disclosed that they do not have a specific policy on reordering medications, but the pharmacy has a process. During an interview on 12/15/2025 at 2:54 PM, Staff B, MD (Medical Doctor) stated Patient #1 was symptomatic with a heart rate in the 30’s and was placed on isoproterenol titrating drip to maintain the heart rate. On Monday (11/18/2025), he found the patient on a ventilator (breathing machine). Staff B, Physician was informed that a code blue (cardiac arrest) was called and CPR was done on Patient #1. He stated the medication isoproterenol was not infusing and the patient went without the medication for greater than 30 minutes. If the medication had not run out, the patient would have been fine and would not have gone into cardiac arrest. During an interview on 12/15/2025 at 3:10 PM, Staff C, Pharmacy Manager, stated the pharmacy received the medication request from the nurse on 11/17/2025 8:31 AM and the pharmacy tech acknowledged the request at 8:32 AM. It went through the normal process and was sent to the floor within 30 to 35 minutes. If the nurse would have informed us the isoproterenol medication was low or had run out, a new bag of the medication would have been sent there immediately and not thru the tube station; that is the correct process. During an interview on 12/15/2025 at 3:15 PM, the Pharmacy Operations Supervisor stated the stability of Isoproterenol would not have lasted long unrefrigerated and that is why there was not an extra bag in CVICU (cardiovascular intensive care unit). During an interview on 12/16/2025 at 3:25 PM, the Regional Quality Director stated given the cost of the medication, is not commonly used at their facility this is probably why it was not readily available. Review of the Isoproterenol (medication used to treat serious heart rhythm problems and medication to increase the heart rate) drugdex (drug information sheet) provided by facility revealed that isoproterenol hydrochloride in normal saline (NS) final concentration of 4 mcg/ml (micrograms per milliliter) in 250 ml(milliliter) NS bag is stable for up to 90 days when stored under light protection at room temp.”

“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: 42154 Based on review of facility policy, medical records, and staff interviews, the facility failed to ensure nursing staff supervision in the delivery of care for a patient receiving life-sustaining cardiac medication (isoproterenol) as ordered in one (1) of two patients reviewed who were on isoproterenol. This failure resulted in the patient requiring resuscitation; the patient subsequently expired on 11/23/2025. Findings included: Review of the policy and procedure titled, “Assessment/ Reassessment of (Adult) Patients”, # NCL0132, last reviewed 07/2025, ... reassessment A. the patient status is reassessed at regular intervals. Reassessment is triggered by changes in patient’s condition or needs ...determine the response to effectiveness of care and interventions ... reassessment is completed ... patient is at risk for adverse outcome ... response to treatment ... Review of the medical record for Patient #1 revealed that Patient #1 came into the Emergency Department (ED) and was found to have a heart rate in the 30’s (normal heart rate is 60-100), he was found to have 2nd degree Mobitz type 1 heart block (condition where electrical signals from the atria to the ventricles slows down). Patient #1 was placed on an isoproterenol drip (medication to increase the heart rate). The last documented isoproterenol Intravenous (IV) drip bag hung up was 11/17/2025 at 6:10 AM, running at a rate of 105 milliliter (ml)/ hour (hr) with the bag volume of 250 ml (which means at 8:10 AM there was 210 ml infused and at 8:32 AM the bag would be empty). On 11/17/2025 9:16 AM, Patient #1 had an asystolic cardiac arrest (heart stops electrical and mechanical activity). There was no documentation after 6:10 AM that the nurse hung a new isoproterenol bag. Review of the physician Progress note dated 11/18/2025 9:09 AM revealed that Patient #1 suffered brief asystole cardiac arrest requiring (cardiopulmonary resuscitation) CPR as there was 50 minutes delay to restart isoproterenol. He required mechanical ventilation. On 12/11/2025 at 8:41 AM physician progress note showed “that we could not say with certainty that this lapse did not result in cardiac arrest.” During an interview on 12/15/2025 at 2:54 PM, Staff B, Physician stated he was on-call (available) the weekend Patient #1 came in. Patient #1 was symptomatic with a heart rate in the 30’s and was placed on isoproterenol titrating drip to maintain a heart rate. Staff B, Physician said he completed rounds on Sunday the patient was watching television. When he came in Monday for his next rounds in Cardiovascular Intensive Care Unit (CVICU) he found the patient on a ventilator. Staff B, Physician was informed that a code blue (cardiac arrest alert) was called and CPR was done on the patient. He disclosed that the medication, isoproterenol, was not going and the patient was without the medication for greater than 30 minutes. He stated if the medication had not run out the “patient would have been fine” and would not have gone into cardiac arrest. During an interview on 12/15/2025 at 3:10 PM, Staff C, Pharmacy Manager said the pharmacy received the request from the nurse on 11/17/2025 8:31 AM and the pharmacy tech acknowledge the request at 8:32 AM, in which it was sent to the compounding room (a highly controlled specialized area that is strict cleanliness to prevent contamination) It went through the process and at 9:05 AM the CVICU charge nurse called saying that it was running low; at 9:08 AM the new bag was sent through the tube system to the CVICU. Staff C, Pharmacy Manager disclosed that if they had called earlier that the isoproterenol medication was low or ran out, the bag would have been sent up there immediately. During an interview on 12/15/2205 at 1:44 PM, Staff A, RN stated that she received report from 7:00 AM to 7:30 AM and she rounded on her patients after report. Staff A, RN disclosed that at approximately 8:15 AM to 8:20 AM she went into Patient #1’s room at which time she noticed the patient needed a new isoproterenol bag so she sent the request at 8:31 AM. Patient #1 coded.”

“PHARMACIST SUPERVISION OF SERVICES CFR(s): 482.25(b)(1) §482.25(b)(1) - All compounding, packaging, and dispensing of drugs and biologicals must be under the supervision of a pharmacist and performed consistent with State and Federal laws. This Standard is not met as evidenced by: 42154 Based on review of the facility medication guide, facility policies and staff interviews the facility failed to ensure lifesaving medication were current and ready for immediate use to meet patient needs in 1 (Patient #1) of 2 isoproterenol cardiac medication reviewed. Not having immediate availability of physician ordered lifesaving medications can place all patients in the cardiovascular intensive care unit (CVICU) in jeopardy and was involved in the decrease and cessure of Patient #1’s heart activity. Findings included: Review of the Isoproterenol drugdex provided by facility revealed that isoproterenol hydrochloride in normal saline (NS) final concentration of 4 mcg/ml in 250 ml NS bag stable for up to 90 days when stored under light protection at room temp. Review of the Policy titled, “Medication Ordering”, last revision 04/2025 ...Medication order processing: 1. Pharmacist review all medication orders prior to administration to a patient unless in an emergency (risk of not administering immediately outweighs the risk of no pharmacist oversight) or under direct supervision of an authorized prescriber ...5. Expected turnaround times for medication order processing within 30 minutes ...c. Patient conditions may warrant changes to theses expected turnaround times to match the appropriate level of care ... Review of the facility pharmacy medication requests revealed that on 11/16/2025 at 9:35 PM Staff Register Nurse (RN) in CVICU requested isoproterenol Intravenous (IV) bag with a response from pharmacy “should still have at least 1 bag in fridge, please let us know when you hang that one at least 1 hour before needed”. On 11/17/2025 at 5:06 AM Staff RN in CVICU requested isoproterenol IV bag with a response from pharmacy “you should have 1 left in fridge, Patient-specific Med in Fridge”. On 11/17/2025 at 8:31 AM Staff RN in CVICU requested isoproterenol IV bag “Not in Pyxis”( medication dispensing machine) with a response from pharmacy “Medication to be Tubed”. During an interview on 12/15/2025 at 11:00 AM, Staff D, Quality Manager stated they do not have a specific policy on reordering medications, but the pharmacy has a process. During an interview on 12/15/2025 at 3:10 PM, Staff C, Pharmacy Manager said the pharmacy received the request from the nurse on 11/17/2025 8:31 AM and the pharmacy tech acknowledge the request at 8:32 AM, in which it was sent to the compounding room (a highly controlled specialized area that is strict cleanliness to prevent contamination). It went through the process and at 9:05 AM the CVICU charge nurse called saying that it was running low and at 9:08 AM the new bag was sent through the tube system to the CVICU. Staff C, Pharmacy Manager stated if they had called earlier that the isoproterenol medication was low or ran out, the bag would have been sent there immediately. During an interview on 12/15/2025 at 3:15 PM, Staff E, Pharmacy Operations Supervisor stated the stability of Isoproterenol would not have lasted long un-refrigerated and that is why there was not an extra bag in CVICU. During an interview on 12/16/2025 at 3:25 PM, the Regional Quality Director stated given the cost of the medication and is not commonly used at their facility, this is probably why it was not readily available.”

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 36678 Based on record review, policy review, and interviews, the hospital failed to ensure the safety of 1 (Patient #1) of 4 patients sampled. The standard of practice for managing critical radiology findings for dissections was not properly implemented for emergent and life-threatening conditions, contributing to the death of Patient #1. Refer to A0144 Patient Rights: Care in a Safe Setting, CFR 482.13. The facility provided an Immediate Jeopardy removal plan on 09/11/2025. The immediacy was determined to be removed 2:30 PM on 09/11/2025. The actions included: Review of physician Quality of Care, Medical Staff Peer Review Process Completed Completion Date: 7/15/25 The physician will complete the education modules in Emergency Medicine minefield navigator focusing on management of life-threatening emergencies and effective inter physician communication. The physician must submit proof of completion to Medical Staff Office within 60 days. Completion Date: 9/1/25 Review of policy and procedure for diagnostic imagining related to CVA (Cerebrovascular Accident, which is another name for a stroke) vs TIA (transient ischemic attack, is a “mini-stroke”) to include CTA (Computed Tomographic Angiography, a medical imaging technique) evaluation. Completion Date: 7/15/25 Review of Communication of Critical Results Policy and Procedure Meeting conducted on 8/7/2025 including MEC Chair and Radiology Chair. Meeting conducted on 8/13/2025 including MEC (Medical Executive Committee) Chair, and Radiology Chair, and CMO (Chief Medical Officer). Completion Date: 8/13/2025 Creation of Standardized Pathway for Type A (Type A dissecting aortic aneurysm is a medical emergency where the inner layer of the aorta tears in the ascending aorta, the part that curves up from the heart) & B (Type B aortic dissection is a tear in the inner layer of the aorta, specifically in the descending aorta (the lower part of the aorta))Aortic Dissections. Completion Date: 9/9/2025 Creation of Standardized Pathway for Carotid Dissections (a condition where the inner lining of the carotid artery, which carries blood to the brain, tears or separates). Completion Date: 9/9/25 Process for Communication of Critical Radiology Results. Completion Date: 9/11/25, and ongoing Audits of communication and outcome of critical radiology results will be conducted by Medical Staff and Quality Improvement on a daily basis for 4 weeks, and then monthly for 3 months, then quarterly thereafter. Results will be reported to: Medical Staff Peer Review Committee meeting monthly x 6 months, Board Clinical Excellence Committee meetings x 3 meetings (or ongoing if issues arise).”

“QAPI CFR(s): 482.21 The hospital must develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program. The hospital’s governing body must ensure that the program reflects the complexity of the hospital’s organization and services; involves all hospital departments and services (including those services furnished under contract or arrangement); and focuses on indicators related to improved health outcomes and the prevention and reduction of medical errors. The hospital must maintain and demonstrate evidence of its QAPI program for review by CMS. This Condition is not met as evidenced by: 36678 Based on record review, interviews, policy review, and facility corrective action review, the hospital failed to ensure appropriate communication mechanisms were implemented for delivering critical imaging results to appropriate Medical Staff during a medical emergency, and that an appropriate corrective action plan was implemented after identification of a serious adverse event that resulted in the cardiac arrest and death of Patient #1. Refer to A0286 Patient Safety, CFR 482.21.”

“MEDICAL STAFF CFR(s): 482.22 The hospital must have an organized medical staff that operates under bylaws approved by the governing body, and which is responsible for the quality of medical care provided to patients by the hospital. This Condition is not met as evidenced by: 36678 Based on record review, policy review, corrective action plan review and interviews, the hospital failed to ensure continuity of communication between physicians regarding critical radiological (imaging) results, implement an emergent consult to a cardiothoracic surgeon, and transfer to a higher level of care, resulting in the discharge and death of 1 (Patient #1) of 4 patients sampled. Failure to communicate, treat and transfer resulted in the death of Patient #1. Refer to A0347 Medical Staff Organization and Accountability, CFR 482.22 Review of physician Quality of Care, Medical Staff Peer Review Process Completed Completion Date: 7/15/25 The physician will complete the education modules in Emergency Medicine minefield navigator focusing on management of life-threatening emergencies and effective inter physician communication. The physician must submit proof of completion to Medical Staff Office within 60 days. Completion Date: 9/1/25 Review of policy and procedure for diagnostic imagining related to CVA (Cerebrovascular Accident, which is another name for a stroke) vs TIA (transient ischemic attack, is a “mini-stroke”) to include CTA (Computed Tomographic Angiography, a medical imaging technique) evaluation. Completion Date: 7/15/25 Review of Communication of Critical Results Policy and Procedure Meeting conducted on 8/7/2025 including MEC Chair and Radiology Chair. Meeting conducted on 8/13/2025 including MEC (Medical Executive Committee) Chair, and Radiology Chair, and CMO (Chief Medical Officer). Completion Date: 8/13/2025 Creation of Standardized Pathway for Type A (Type A dissecting aortic aneurysm is a medical emergency where the inner layer of the aorta tears in the ascending aorta, the part that curves up from the heart) & B (Type B aortic dissection is a tear in the inner layer of the aorta, specifically in the descending aorta (the lower part of the aorta))Aortic Dissections. Completion Date: 9/9/2025 Creation of Standardized Pathway for Carotid Dissections (a condition where the inner lining of the carotid artery, which carries blood to the brain, tears or separates). Completion Date: 9/9/25 Process for Communication of Critical Radiology Results. Completion Date: 9/11/25, and ongoing Audits of communication and outcome of critical radiology results will be conducted by Medical Staff and Quality Improvement on a daily basis for 4 weeks, and then monthly for 3 months, then quarterly thereafter. Results will be reported to: Medical Staff Peer Review Committee meeting monthly x 6 months, Board Clinical Excellence Committee meetings x 3 meetings (or ongoing if issues arise).”

“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 record review, policy review and interviews, the hospital failed to ensure the standard of care was followed for reporting critical imaging results prior to discharge for 1 (Patient #1) of 4 patients sampled. Failure to follow the standard of care resulted in the death of Patient #1. Findings included: A review of the medical record for Patient #1 reflected Patient #1 came to the hospital ED (Emergency Department) by ambulance on 6/26/2025 for stroke-like symptoms, that resolved in the ambulance on the way to the hospital. A Doppler ultrasound of the neck and carotid arteries was completed in the ED and showed findings of an abnormality concerning for dissection of the right carotid artery. Patient #1 was admitted for further observation and testing. On 6/27/2025 a CT (computed tomography) angiogram of the neck and carotid arteries was completed. During the imaging study, Staff D, CT Coordinator, communicated findings of right carotid artery dissection along with Type A thoracic aorta dissection. This was also communicated to Staff A, Hospitalist by Staff F, RN (Registered Nurse), who had been informed by Staff B, Radiologist, after he interpreted the imaging. Staff A, Hospitalist indicated in his Discharge Summary, that this was communicated with and discussed with Neurologist, Staff C, who recommended anticoagulation therapy (blood thinners) and follow-up outpatient with neurology. The patient was discharged home with a diagnosis of TIA-transient ischemic attack (pre-stroke symptoms), and instructions to take aspirin and Plavix, and follow up with a neurologist in 3 weeks. Upon review of the imaging results the next day, 6/28/25, the Neurologist, Staff C, discovered the Type A thoracic dissection. She attempted to contact Patient #1 and was unable to reach her directly but did speak to the patient’s family member and told him of the emergent nature of the findings and advised him Patient #1 needed to return to the ED immediately. Patient #1 did not return. However, the next day, 6/29/25 at 6:15 PM she was brought in by ambulance in cardiac arrest. Patient #1 was unable to be revived, and the time of death was called in the ED at 6:28 PM. Review of the policy, Communication of Stroke, Critical Results, and Stat/Wet Read, January 2024, revealed the following: Critical Results Communication (Excluding Storke Alerts) or Exams made Stat/wet Read by Radiologist Any critical finding, as identified by the reading radiologist, will be communicated to the appropriate healthcare provider as outlined below: Reading Radiologist communicates critical results to Ordering Physician and/or ISR/ISOA (Imaging Services Representative/Imaging Services Operations Specialist). ISR/ISOA confirms critical communication result between Radiologist and Ordering Physician (or Hospitalist that has assumed care for the patient if shift change occurs), as follows: Scenario A If the Radiologist confirmed contact with the ordering physician, ISR/IOA will document protocol in RIS (Radiologist Information System) to include date, time, and name of physician spoken to. Scenario B: If the Radiologist is unable to confirm contact with the Ordering Physician, ISR/IOA will contact the Ordering Physician, relay the results, and ask if they wish to be connected with the Radiologist. During an interview on 09/09/2025 at 10:10 AM, Staff G, Radiologist, stated he calls the referring physician or ordering physician, but if he cannot reach them then he calls the floor nurse. If he cannot get the floor nurse, then he would call the supervisor. An urgent finding requires a call. Often the ordering physician is either not available, or he cannot find the number to call him in the system. Sometimes the ordering physician will call back. During an interview on 09/09/2025 at 10:13 AM, Staff D, CT coordinator, stated she called the attending Staff A, hospitalist, to ask if he wanted more scans. He said it is not in his scope; it was neurology and that he was just the ordering physician. Staff A, Hospitalist, suggested a stat neurology consult. “We were in the process of still doing the study. It hadn’t been sent yet.” The radiologist cannot do anything until the images are in the computer. Staff D, CT Coordinator, said she called Staff B, Radiologist, for a stat read. She called the nurse after she spoke to Staff A, hospitalist. The patient’s nurse was busy, so she called the charge nurse. There has been no change to communication that she is aware of. During an interview on 09/09/2025 at 1:20 PM, the Manager of Imaging stated most of the time a critical report goes from the radiologist to the ordering physician. It goes from the report to the nurse to the doctor. The doctor can call the radiologist with questions. Staff D, CT Coordinator called the physician because she saw the abnormality and wanted to know if he wanted to expand the scan, because it is easier to do it while we’re there. Otherwise, if they sent the patient back, they would have to insert another IV (intravenous), get another big order block set. It is a courtesy so we can do it while we’re there. They cannot ask the radiologist to order an expanded test, they have to call the ordering physician. Staff D, CT Coordinator wasn’t calling to report the result, she was asking how far up (arteries) he wanted her to look. The radiologist is the only one who can read results. The physician can request a technologist to read a report, but the results are only provided by the radiologist. She was letting him know there was a finding and asking if he wanted to expand the scan. During a group interview on 09/10/2025 at 10:40 AM with the Quality Director and the Risk Manager (RM), the Quality Director said radiology called the nurse. The nurse used the patient safe phone and texted Staff A, Hospitalist, the results. We have a high level of confidence that the hospitalist knew what the radiologist saw so he called Staff C, Tele-Neurology. Now, it is he said, she said. Staff A, Hospitalist said he told Staff C, Neurologist, there was a Type A dissection. Staff C, Neurologist, said if she knew it was Type A aortic dissection, she would not have discharged the patient. Staff A should have called cardiothoracic surgery. Then, Risk Manager disclosed that there were two things going on at the same time. Staff D, CT Coordinator, noticed it (the dissection) was extending and called Staff A, Hospitalist. She asked if he wanted further scans. He said no. He stated he wanted a stat consult with neurology. At the same time, the radiologist received the images and called the nurse with the results. The nurse texted Staff A, Hospitalist, with the results. He said to do a stat neurology consult. He talked to the Neurologist, Staff A, and the plan was for anticoagulation, to discharge home and follow-up outpatient because it was a carotid dissection. Staff A, Hospitalist, knew about it. He did not understand what he had. The report was not available when he was making those decisions. He did not understand what he was looking at. Staff C, Neurologist, said she was doing an audit. She said she looks at all her charts and does an audit, and because she did not see the scan report yet. When she tried to call Patient #1, she did not answer. When the voice mail came on there wasn’t enough identifying information for her to leave a voice mail. She called the family member who was on the Face Sheet and was in the room on the day of discharge. The family member said she was out shopping and wouldn’t answer her phone. Staff C, Neurologist, communicated that Patient #1 needed to be brought back to the hospital. Patient #1 never came back. She refused the CTA initially in the ED. It would have been caught in the ED, and she would have been transferred. The hospitalists never see these. The patients are transferred out. Staff A, Hospitalist, said he never sees these. He did not know what to do. Since the neurologist ordered the test, he called her. The neurologist said she was under the impression they were still discussing the carotid dissection, and that’s why she told him to continue the current treatment plan. It was almost 25 hours after they found the dissection that she came back through the ED. The only reason we knew about it was that the CT technologist was working in the ED CT and recognized the name. During a telephone interview on 09/10/2025 at 10:43 AM, Staff A, Hospitalist, said Patient #1 came with neurologic symptoms. The Neurologist ordered a CT scan. The study was obtained and the technologist called about the abnormality. Staff A, Hospitalist said he discussed it with Staff C, Neurologist, and she thought it was carotid dissection, not aortic. She based the treatment on the ultrasound report, which was an ambiguous element of abnormality. She ordered a CT angiogram the next morning routine, but he changed it to stat because the patient wanted to go home. Staff A, Hospitalist said he communicated the discharge plan with the patient and she was in agreement. The neurologist said it was ok for carotid and thoracic dissection. The patient was hemodynamically stable (describes a patient whose vital signs, including heart rate, blood pressure, and oxygen saturation, are within normal ranges, indicating that their circulatory system is functioning adequately without immediate risk of life-threatening complications) and was discharged.”

“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: 36678 Based on record review, policy review, facility corrective action plan review, and interviews, the hospital failed to ensure corrective measures were implemented, including a plan to monitor, track, trend, and analyze, after a serious adverse event was identified that resulted in the death of Patient #1, for 1 of 1 QAPI (Quality Assurance Performance Improvement) plan. Findings included: A review of the medical record revealed Patient #1 came to the hospital ED (Emergency Department) by ambulance on 6/26/2025 for stroke-like symptoms, the symptoms resolved in the ambulance on the way to the hospital. An ultrasound of the neck and carotid arteries was completed in the ED and findings showed an abnormality concerning dissection of the right carotid artery. Patient #1 was admitted for further observation and testing. On 6/27/2025 a CT (computed tomography) angiogram (a medical imaging technique that uses X-rays to create detailed images of blood vessels) of the neck and carotid arteries was completed. During the imaging study, Staff D, CT Coordinator, communicated findings of right carotid artery dissection along with Type A thoracic aorta dissection (a life-threatening condition where the inner layer of the aorta (the main artery that carries blood from the heart to the body) tears and separates, creating a new channel (false lumen) within the aortic wall) to Staff A, Hospitalists. This was also communicated to Staff A, Hospitalist by Staff F, RN (Registered Nurse), who had been informed by Staff B, Radiologist, after he interpreted the imaging. Staff A, Hospitalist indicated in his Discharge Summary, that this was communicated and discussed with Staff C, Neurologist who recommended anticoagulation therapy (blood thinners) and follow-up outpatient with neurology. The patient was discharged home with a diagnosis of TIA-transient ischemic attack (pre-stroke symptoms) with instructions to take aspirin and Plavix and follow up with a neurologist in 3 weeks. Upon review of the imaging results the next day, 6/28/2025, the Staff C, Neurologist, discovered the Type A thoracic dissection. She attempted to contact Patient #1 and was unable to reach her but did speak to the patient’s family member. Staff C, Neurologists informed the family member the emergent nature of the findings and advised Patient #1 needed to return to the ED immediately. Patient #1 did not return. The next day, 6/29/2025 at 6:15 PM, Patient #1 was brought in by ambulance in cardiac arrest. Patient #1 was unable to be revived, and the time of death was called in the ED at 6:28 PM. Review of the policy, Communication of Stroke, Critical Results, and Stat/Wet Read, January 24, revealed the following: Critical Results Communication (Excluding Storke Alerts) or Exams made Stat/wet Read by Radiologist Any critical finding, as identified by the reading radiologist, will be communicated to the appropriate healthcare provider as outlined below: Reading Radiologist communicates critical results to Ordering Physician and/or ISR/ISOA (Imaging Services Representative/Imaging Services Operations Specialist). ISR/ISOA confirms critical communication result between Radiologist and Ordering Physician (or Hospitalist that has assumed care for the patient if shift change occurs), as follows: Scenario A If the Radiologist confirmed contact with the ordering physician, ISR/IOA will document protocol in RIS (Radiologist Information System) to include date, time, and name of physician spoken to. Scenario B: If theRradiologist is unable to confirm contact with the Ordering Physician, ISR/IOA will contact the ordering physician, relay the results, and ask if they wish to be connected with the radiologist. Review of facility corrective action dated 7/14/2025 reflected the following actions: 1. Collaboration with Radiology concerning the communication of life threatening critical results between physicians. Review policy NCL 0039 (Critical Results, Communication of) for clarification of acceptable recipients of critical values. Discuss the expansion of diagnostic imaging pathways when life threatening and critical results are identified. 2. Development of pathways and algorithms for inpatient treatment of all types of dissections to include placement, transfers, consultations, and additional diagnostic testing. Review of electronic communication from the CMO to the department heads of the hospitalist groups, dated 9/2/2025 reflected a Subject: Radiology Communication: See attached meeting minutes regarding communication of radiology results. I have highlighted a phone number just in case the provider wants to connect with radiology to verify/discuss the radiology results. Attached was meeting minutes from August 13, 2025 regarding no change to the policy, but included the direct line with extension for providers to contact the Radiologist. Review of electronic communication sent to all hospitalists on 9/9/25 at 9:24 PM reflected the development of Pathways for Carotid Dissection-Symptomatic Patients, Type A Aortic Dissection, and Type B Aortic Dissection. Additional corrective action review reflected electronic communication from the Quality Director, dated 9/10/2025, addressed to the Manager of Imaging and the Supervisor of Imaging: Educate and implement new process and train team members, due date 10/1/2025. Distribute AOD (Administrator on Duty) and the hospital phone directory, hospitalist phone list, and ED physician list to other team members for communication after business hours and on weekends. Due date 10/1/25. A review of the 2025 QAPI Plan reflected the following: Scope: Quality Improvement and Patient Safety activities are conducted with an interdisciplinary approach between hospital and medical staff and include inpatient and outpatient services provided at the hospital. Sentinel Events Risk Management department tracks, trends, collects data, and reports events WINTER HAVEN HOSPITAL CLINICAL EXCELLENCE COMMITTEE (CEC) OF THE BOARD The Clinical Excellence Committee of the Board (Board CEC) derives its authority from the Board of Trustees. The Committee has been delegated the responsibility for oversight of the continuous improvement of the organization’s processes. Board CEC shall be responsible for oversight of the quality philosophy and process. Implementation of improvement actions is the responsibility of hospital administration and medical staff leadership. MEDICAL EXECUTIVE COMMITTEE Inform the Medical Staff on quality and safety issues. Review quality, safety and patient satisfaction performance measures related to the medical staff. o Implement quality improvement and patient safety in medical staff processes. During an interview on 09/09/2025 at 10:10 AM, Staff G, Radiologist said he calls the referring physician or ordering physician. They are rarely on the floor, so if he cannot reach them then he calls the floor nurse. If he cannot get the nurse, then he would call the supervisor. An urgent finding requires a call. Often times the ordering physician is not available, or he cannot find them in the system. Sometimes the ordering physician calls back. During a interview on 09/09/2025 at 10:13 AM, Staff D, CT coordinator stated she called the attending hospitalist to ask if he wanted more scans. He said it’s not in his scope; it was neurology. He was the ordering physician. He suggested a stat neurology consult. “We were in the process of doing the study. It hadn’t been sent yet.” The radiologist cannot do anything until the images are in the computer. Staff D, CT coordinator, said she called him for a stat read. She called the nurse after she spoke to the physician. The patient’s nurse was busy, so she called the charge nurse. There has been no change to communication that she is aware of. During a telephone interview on 09/09/2025 at 10:44 AM, the Medical Director of Radiology said he has had several meetings with the CMO and Medical Quality Staff. He has spoken to the physician and the radiologists. They need to read the report and see if it says what we mean it to say. There wasn’t documentation that the radiologist contacted the physician. It should be physician to care team. If the doctor is not available, then licensed clinical staff. The Medical Director of Radiology said he doesn’t know if the final document was put out by the CMO and Medical Quality Staff. It was verbal from himself to the group. The radiologist was new to the group. There were mentors who spoke to him directly. There wouldn’t be a paper trail. “If you’re asking if we’re auditing something, I cannot answer that.” That would be the Medical Quality Staff. During an interview on 09/09/2025 at 12:02 PM, the CMO stated that several elements came out of the analysis. Communicating with hospital medicine and radiology department and bringing them together to see if there was any opportunity to streamline the communication. They reviewed the policy that governs the communication for radiology for emergent imaging studies. They met with the radiology department, the chair of the Medical Executive Committee and himself to see if there were opportunities. They reviewed the process and the policy. The process was determined to be intact. A change in the process would probably confuse people. Once the hospitalist receives the critical result, the hospitalist should communicate that back to the radiologist. It is on the agenda for a hospitalist collaborative that is scheduled 9/17/2025. We will discuss consultative referral patterns. It hasn’t happened yet. The hospitalists will communicate in their monthly meeting if any similar occurrence happens. There hasn’t been one. We have not taken this to Medical Quality. This is the hospitalist general meeting. During an interview on 09/09/2025 at 12:36 PM, the Quality Manger confirmed the hospitalist collaborative meeting was scheduled for 9/17/2025 (over 2 and half months after Patient #1 died). During an interview on 09/09/2025 at 1:15 PM, the Quality Manager said they rely on the Incident Reporting System to track any future occurrences. Quality looks at all those event reports. We are in the system looking at mortalities and errors. We should be tracking critical values and the physicians calling the criticals back. There are actions that don’t require follow-up and there are those that need auditing. “In this particular case, I cannot show you any audits.” We cannot pull critical result reports for radiology. During an interview on 09/09/2025 at 3:48 PM, the Quality Director stated a cardiothoracic surgeon should have been consulted for a course of action. There isn’t a protocol or standard of care for dissection. The second item on the corrective action is the one the CMO is going to talk about at the hospitalist collaborative meeting on September 17th. During a group interview on 09/10/2025 at 10:40 AM with the Quality Director and the Risk Manager, the Quality Director said radiology called the nurse. The nurse used the patient safe phone and texted the hospitalist the results. We have a high level of confidence that the hospitalist knew what the radiologist saw. He called tele-neurology. Now it’s he said, she said. Staff A, Hospitalist said he told the Neurologist, Staff C there was a Type A dissection. Staff C, Neurologist, said if she knew it was Type A aortic, she would not have discharged the patient. Staff A should have called cardiothoracic surgery. The Risk Manager said there were two things going on at the same time. Staff D, CT Coordinator, noticed it was extending and called Staff A, Hospitalist. She asked if he wanted further scans and he stated he wanted a stat consult with neurology. At the same time, the radiologist received the images and called the nurse with the results. The nurse texted Staff A, Hospitalist with the results. He said to do a stat neurology consult. He talked to the neurologist, and the plan was for anticoagulation and to discharge home and follow-up outpatient because it was a carotid dissection. Staff A, Hospitalist knew about it. He did not understand what he had. The report was not available when he was making those decisions. He did not understand what he was looking at. Staff C, Neurologist said she was doing an audit. She said she looks at all her charts and does an audit, and since she did not see the scan report yet. When she tried to call Patient #1, she did not answer. When the voice mail came on there wasn’t enough identifying information for her to leave a voice mail. She called the family who was on the Face sheet and was in the room on the day of discharge. The family member said she was out shopping and wouldn’t answer her phone. Staff C, Neurologist communicated that Patient #1 needed to be brought back to the hospital. Patient #1 never came back. She refused the CTA initially in the ED. It would have been caught in the ED and she would have been transferred. The hospitalists never see these. The patients are transferred out. Staff A, Hospitalist said he never sees these. He did not know what to do. Since the neurologist ordered the test, he called her. It was almost 25 hours after they found the dissection that she came back through the ED. The only reason we knew about it was that the CT technologist was working in the ED CT and recognized the name. The policy was followed. The results were reported to the nurse which the policy says can be done. The gap was the physician did not know what to do, and the CT was ordered routine. Auditing the critical results is something we should do, but that was not the issue. When they were addressing the policy, they wanted the radiologist to call the physician directly, but there were a lot of physician leaders in that meeting and they decided that wasn’t reasonable, and did not make that policy change. The neurologist’s direct supervisor is now not answering any of my texts or calls. RM said she interviewed the neurologist, who said she was under the impression they were still discussing the carotid dissection, and that’s why she told him to continue the current treatment plan (confirmed by documented interview from RM investigation). Auditing the critical results is something we should do, but that was not the issue. When they were addressing the policy, they wanted the radiologist to call the physician directly, but there were a lot of physician leaders in that meeting and they decided that wasn’t reasonable, and did not make that policy change. The neurologist’s direct supervisor is now not answering any of my texts or calls. RM said she interviewed the neurologist, who said she was under the impression they were still discussing the carotid dissection, and that’s why she told him to continue the current treatment plan (confirmed by documented interview from RM investigation). During a telephone interview on 09/10/2025 at 10:43 AM, Staff A, Hospitalist said Patient #1 came with neurologic symptoms. The Neurologist ordered a CT scan. The study was obtained and the technologist called about the abnormality. Staff A, Hospitalist said he discussed it with Staff C, Neurologist, and she thought it was carotid dissection, not aortic. She based the treatment on the ultrasound report, which was an ambiguous element of abnormality. She ordered a CT angiogram the next morning routine, but he changed it to stat because the patient wanted to go home. Staff A, Hospitalist said he communicated the discharge plan with the patient and she was in agreement. The neurologist said it was ok for carotid and thoracic dissection. The patient was hemodynamically stable(describes a patient whose vital signs, including heart rate, blood pressure, and oxygen saturation, are within normal ranges, indicating that their circulatory system is functioning adequately without immediate risk of life-threatening complications) and was discharged.”

“MEDICAL STAFF ORGANIZATION & ACCOUNTABILITY CFR(s): 482.22(b)(1), (2), (3) The medical staff must be well organized and accountable to the governing body for the quality of the medical care provided to the patients. (1) The medical staff must be organized in a manner approved by the governing body. (2) If the medical staff has an executive committee, a majority of the members of the committee must be doctors of medicine or osteopathy. (3) The responsibility for organization and conduct of the medical staff must be assigned only to one of the following: (i) An individual doctor of medicine or osteopathy. (ii) A doctor of dental surgery or dental medicine, when permitted by State law of the State in which the hospital is located. (iii) A doctor of podiatric medicine, when permitted by State law of the State in which the hospital is located. This Standard is not met as evidenced by: 36678 Based on record review, policy review, corrective action plan, and interviews conducted, the hospital failed to ensure critical imaging results were communicated appropriately by the radiologist to the physician, and that critical results were acted upon appropriately in order to prevent the death of 1 (Patient #1) of 4 patients sampled. Findings included: A review of the medical record revealed Patient #1 came to the hospital ED (Emergency Department) by ambulance on 6/26/2025 for stroke-like symptoms, the symptoms resolved in the ambulance on the way to the hospital. An ultrasound of the neck and carotid arteries was completed in the ED and findings showed an abnormality concerning dissection of the right carotid artery. Patient #1 was admitted for further observation and testing. On 6/27/2025 a CT (computed tomography) angiogram (a medical imaging technique that uses X-rays to create detailed images of blood vessels) of the neck and carotid arteries was completed. During the imaging study, Staff D, CT Coordinator, communicated findings of right carotid artery dissection along with Type A thoracic aorta dissection (a life-threatening condition where the inner layer of the aorta (the main artery that carries blood from the heart to the body) tears and separates, creating a new channel (false lumen) within the aortic wall) to Staff A, Hospitalists. This was also communicated to Staff A, Hospitalist by Staff F, RN (Registered Nurse), who had been informed by Staff B, Radiologist, after he interpreted the imaging. Staff A, Hospitalist indicated in his Discharge Summary, that this was communicated and discussed with Staff C, Neurologist who recommended anticoagulation therapy (blood thinners) and follow-up outpatient with neurology. The patient was discharged home with a diagnosis of TIA-transient ischemic attack (pre-stroke symptoms) with instructions to take aspirin and Plavix and follow up with a neurologist in 3 weeks. Upon review of the imaging results the next day, 6/28/2025, the Staff C, Neurologist, discovered the Type A thoracic dissection. She attempted to contact Patient #1 and was unable to reach her but did speak to the patient’s family member. Staff C, Neurologists informed the family member the emergent nature of the findings and advised Patient #1 needed to return to the ED immediately. Patient #1 did not return. The next day, 6/29/2025 at 6:15 PM, Patient #1 was brought in by ambulance in cardiac arrest. Patient #1 was unable to be revived, and the time of death was called in the ED at 6:28 PM. Review of the policy, Communication of Stroke, Critical Results, and Stat/Wet Read, January 2024, revealed the following: Critical Results Communication (Excluding Storke Alerts) or Exams made Stat/wet Read by Radiologist Any critical finding, as identified by the reading radiologist, will be communicated to the appropriate healthcare provider as outlined below: Reading Radiologist communicates critical results to Ordering Physician and/or ISR/ISOA (Imaging Services Representative/Imaging Services Operations Specialist). ISR/ISOA confirms critical communication result between Radiologist and Ordering Physician (or Hospitalist that has assumed care for the patient if shift change occurs), as follows: Scenario A If the Radiologist confirmed contact with the ordering physician, ISR/IOA will document protocol in RIS (Radiologist Information System) to include date, time, and name of physician spoken to. Scenario B: If the Radiologist is unable to confirm contact with the Ordering Physician, ISR/IOA will contact the ordering physician, relay the results, and ask if they wish to be connected with the radiologist. Review of facility corrective action dated 7/14/2025 reflected the following actions: 1. Collaboration with Radiology concerning the communication of life threatening critical results between physicians. Review policy NCL 0039 (Critical Results, Communication of) for clarification of acceptable recipients of critical values. Discuss the expansion of diagnostic imaging pathways when life threatening and critical results are identified. 2. Development of pathways and algorithms for inpatient treatment of all types of dissections to include placement, transfers, consultations, and additional diagnostic testing. Review of electronic communication from the CMO to the department heads of the hospitalist groups, dated 9/2/2025 reflected a Subject: Radiology Communication: See attached meeting minutes regarding communication of radiology results. I have highlighted a phone number just in case the provider wants to connect with radiology to verify/discuss the radiology results. Attached was meeting minutes from August 13, 2025 regarding no change to the policy, but included the direct line with extension for providers to contact the Radiologist. Review of electronic communication sent to all hospitalists on 09/09/2025 at 9:24 PM reflected the development of Pathways for Carotid Dissection-Symptomatic Patients, Type A Aortic Dissection, and Type B Aortic Dissection. Additional corrective action review reflected electronic communication from the Quality Director, dated 09/10/2025, addressed to the Manager of Imaging and the Supervisor of Imaging: Educate and implement new process and train team members, due date 10/1/2025. Distribute AOD (Administrator on Duty) and the hospital phone directory, hospitalist phone list, and ED physician list to other team members for communication after business hours and on weekends. Due date 10/1/25. During an interview on 09/09/2025 at 10:10 AM, Staff G, Radiologist said he calls the referring physician or ordering physician. They are rarely on the floor, so if he cannot reach them then he calls the floor nurse. If he cannot get the nurse, then he would call the supervisor. An urgent finding requires a call. Often the ordering physician is not available, or he cannot find them in the system. Sometimes the ordering physician calls back. During an interview on 09/09/2025 at 10:13 AM, Staff D, CT coordinator said she called the attending hospitalist (Staff A) to ask if he wanted more scans. He said it’s not in his scope, it was neurology. He was the ordering physician. He suggested a stat neurology consult. “We were in the process of doing the study. It hadn’t been sent yet.” The radiologist cannot do anything until the images are in the computer. Staff D, CT Coordinator, said she called the radiologist (Staff B) for a stat read. She called the nurse after she spoke to the physician (Staff A). The patient’s nurse was busy, so she called the charge nurse. During a telephone interview on 9/9/25 at 10:44 AM, the Medical Director of Radiology said he has had several meetings with the CMO and Medical Quality Staff. He has spoken to the physician and the radiologists. They need to read the report and see if it says what we mean it to say. There wasn’t documentation that the physician contacted the physician. It should be physician to care team. If the doctor is not available, then licensed clinical staff. During an interview on 09/09/2025 at 3:48 PM, the Quality Director, Quality Manager, and the Risk Manager, the Quality Director said a cardiothoracic surgeon should have been consulted for a course of action. There isn’t a protocol or standard of care for dissection. (#2) on the corrective action is the one he is going to talk about at the hospitalist collab on September 17th. During a group interview on 09/10/2025 at 10:40 AM with the Quality Director and the Risk Manager (RM), the Quality Director said radiology called the nurse. The nurse used the patient safe phone and texted the hospitalist (Staff A) the results. We have a high level of confidence that the hospitalist knew what the radiologist saw. He called tele-neurology (Staff C). Now, it’s he said, she said. Staff A, Hospitalist said he told the Neurologist, Staff C there was a Type A dissection. Staff C, Neurologist, said if she knew it was Type A aortic, she would not have discharged the patient. Staff A should have called cardiothoracic surgery. During the interview, The Risk Manager disclosed that there were two things going on at the same time. Staff D, CT Coordinator, noticed it (the dissection) was extending and called Staff A, Hospitalist. She asked if he wanted further scans. He said no. He stated he wanted a stat consult with neurology. At the same time, the radiologist received the images and called the nurse with the results. The nurse texted Staff A, Hospitalist with the results. He said to do a stat neurology consult. He talked to the Neurologist, Staff A, and the plan was for anticoagulation, to discharge home and follow-up outpatient because it was a carotid dissection. Staff A, Hospitalist knew about it. He did not understand what he had. The report was not available when he was making those decisions. He did not understand what he was looking at. Staff C, Neurologist said she was doing an audit. She said she looks at all her charts and does an audit, and because she did not see the scan report yet. When she tried to call Patient #1, she did not answer. When the voice mail came on there wasn’t enough identifying information for her to leave a voice mail. She called the family member who was on the Face Sheet and was in the room on the day of discharge. The family member said she was out shopping and wouldn’t answer her phone. Staff C, Neurologist communicated that Patient #1 needed to be brought back to the hospital. Patient #1 never came back. She refused the CTA initially in the ED. It would have been caught in the ED, and she would have been transferred. The hospitalists never see these. The patients are transferred out. Staff A, Hospitalist said he never sees these. He did not know what to do. Since the neurologist ordered the test, he called her. The neurologist said she was under the impression they were still discussing the carotid dissection, and that’s why she told him to continue the current treatment plan. It was almost 25 hours after they found the dissection that she came back through the ED. The only reason we knew about it was that the CT technologist was working in the ED CT and recognized the name. During a telephone interview on 09/10/2025 at 10:43 AM, Staff A, Hospitalist said Patient #1 came with neurologic symptoms. The Neurologist ordered a CT scan. The study was obtained and the technologist called about the abnormality. Staff A, Hospitalist said he discussed it with Staff C, Neurologist, and she thought it was carotid dissection, not aortic. She based the treatment on the ultrasound report, which was an ambiguous element of abnormality. She ordered a CT angiogram the next morning routine, but he changed it to stat because the patient wanted to go home. Staff A, Hospitalist said he communicated the discharge plan with the patient, and she was in agreement. The neurologist said it was ok for carotid and thoracic dissection. The patient was hemodynamically stable and was discharged. During an interview on 09/10/2025 at 1:20 PM, the Manager of Imaging said most of the time a critical report goes from the radiologist to the ordering physician. It goes from the report to the nurse to the doctor. The doctor can call the radiologist with questions. Staff D, CT Coordinator called the physician because she saw the abnormality and wanted to know if he wanted to expand the scan, because it’s easier to do it while we’re there. Otherwise, if they sent the patient back, they would have to insert another IV (intravenous), get another big order block set. It’s a courtesy so we can do it while we’re there. They cannot ask the radiologist to order an expanded test; they have to call the ordering physician. Staff D, CT Coordinator wasn’t calling to report the result, she was asking how far up (arteries) he wanted her to look. The radiologist is the only one who can read results. The physician can request a technologist to read a report, but the results are only provided by the radiologist. She was letting him know there was a finding and asking if he wanted to expand the scan.”