HCA Florida Brandon Hospital

“COMPLIANCE WITH 489.24 CFR(s): 489.20(l) [The provider agrees,] in the case of a hospital as defined in §489.24(b), to comply with §489.24. This Standard is not met as evidenced by: 25370 Based on facility policy review, medical record review, video footage review, electronic central log review, Facility’s Corrective Action Plan reviews, and interviews conducted, the facility failed to ensure that an appropriate medical screening examination was provided that was within the capability of the hospital’s ED (Emergency Department), including ancillary services routinely available to the emergency department to determine whether or not an emergency medical condition existed for 1 (Patient #15) of 20 patients reviewed. On 12/21/2024 at 12:23 AM, Patient #15 presented to the hospital’s ED with presenting signs and symptoms complaining of chest pain then placed in the hospital’s ED waiting room. At 12:50 AM, Patient #15 is slumped over in wheelchair and male accompanied with patient went to the registration desk asking for help. Patient #15 was pronounced dead on 12/21/24 at 01:33 AM. Refer to Tag -A2406”

“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 review, medical record review, video footage review, electronic central log, review, Facility’s Corrective Action Plan reviews, and interviews conducted, the facility failed to ensure that an appropriate medical screening examination was provided that was 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 existed for 1 (Patient #15) of 20 patients reviewed. Patient #15 presented to the hospital’s ED with presenting signs and symptoms complaining of chest pain, checked in at the registration desk on 12/21/2024 at 12: 23 AM, and then placed in the hospital’s ED waiting room. At 12:50 AM, patient slumped over in wheelchair male accompanied with patient went to the registration desk asking for help. Patient #15 was pronounced dead on 12/21/2024 at 01:33 AM. Findings included: The facility’s policy titled, “EMTALA-Medical Screening Examination and Stabilization” EFFECTIVE DATE:11/1/24. The Policy revealed in part, A hospital must provide an appropriate MSE (Medical Screening Examination) with 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 ...3. Extent of the MSE ...a. Determine if an EMC exists ...Triage is not equivalent to an MSE. Triage entails the clinical assessment of the individual’s presenting signs and symptoms at the time of arrival at the hospital in order to prioritize when the individual will be screened by a physician or other QMP (Qualified Medical Personnel). b. Definition of MSE ...The MSE must be appropriate to the individual’s presenting signs and symptoms and the capability and capacity of the hospital. c. An on-going process. The individual shall be continuously monitored according to the individual’s needs until it is determined whether or not the individual has an EMC.” Review of the Electronic Central Log dated 12/21/24 at 12:23 AM, revealed Patient #15’s reason for the ED visit was listed as “CHEST PAIN.” Review of Part 1 of the video footage (no audio) of the ED lobby dated 12/21/2024, revealed Patient #15 walked into ED (Emergency Department) on 12/21 /2024 at 12:23 AM. After the patient checked in at the registration desk, the patient (Accompanied by a male) was placed in a wheelchair by a PCT (Patient Care technician) and placed in an area of the ED lobby/waiting area. Review of Part 2 of the video footage (no audio) dated 12/21/2024 revealed the following for Patient #15 in the ED waiting area: 12:30 AM- seen leaning forward and placed his right hand on the left side of his chest, was also seen to be restless. 12:33 AM- family member went up to the registration desk and was given an emesis bag (bag for handling vomiting episodes) by the registrar. Family member gives emesis bag to the patient; patient leaned forward with emesis bag in his hand; sat up facial grimacing s and clenching teeth. 12:35 AM- family member was seen going to speak with an individual staff member; family member was seen at the vending machine and brought bottled water to the patient. 12:37 AM- the patient gave the family member used emesis bag; family member was seen throwing the emesis bag in the trash. The registration clerk was seen giving the family member a new emesis bag for the patient. 12:38 AM- the patient was seen drinking water. 12:41 AM- pt seen to be restless, bent over in wheelchair using his right hand rubbing the left side of his abdomen and chest. 12:46 AM-12:48 AM- pt seen having right hand on the left side of chest, and clinching his fist, restless and very uncomfortable. 12:50 AM- face pale in color, and now slumped over in wheelchair, family member went to registration desk asking for help. (definite change in the patient’s condition) Male RN (Registered Nurse) came to assist and is seen checking on the patient. 12:52 AM- another staff member came attempting to assist with moving the patient from the waiting room but had some difficulty pushing the wheelchair. That team member leaves and Patient #15 is still slumped over to the left side and pale in color. A female staff member then comes to assist with moving the patient. She raised Patient #15 legs and wheelchair moved easily towards a stretcher that was brought out. Multiple staff members came out from the main ER to assist with transferring the patient onto the stretcher. The patient was taken to a room in the ED to be evaluated. Patient #15’s medical record was reviewed. Review of the physician’s order dated 12/21/24 at 12:28 A.M., revealed that an EKG (a painless test that measures the electrical activity of the heart) was ordered, 5 minutes after the patient’s arrival to the hospital’s ED. Review of the Emergency Provider Report dated 12/21/24 at 12:31 A.M., “Free Text MDM (Medical Decision Making) Notes: Callout made to waiting area and EKG with no response or location of patient. Will return to waiting area to try and locate patient.” Documentation by the ED physician dated 12/21/24 at 1:39 A.M. revealed in part, “HPI (history of present illness) -Cardiac Arrest ...Patient ...male who presents to the emergency department for evaluation with a chief complaint of chest pain. Limited history available upon initial arrival, however, notified that patient became unresponsive without a pulse in the waiting area. CPR was initiated and patient was rapidly transferred to ER room with CPR in progress. Further history was obtained from son-in-law and daughter arrived at the bedside and states that patient had been complaining of chest pain throughout the day and had an episode of emesis prior to arrival patient also experienced a syncopal (temporary loss of consciousness, usually followed by a rapid and complete recovery) episode prior to arrival.” Further review revealed in part, “Discussed with family regarding poor prognosis given prolonged downtown with over 30 minutes of resuscitation efforts with no return of spontaneous circulation and resuscitation efforts were ultimately ceased. Time of death was called at 1:33 a.m.” There was an inappropriate delay between Patient #15’s arrival to the ED, and provision of the medical screening examination as evidence by failing to triage the patient, no vital signs and EKG were performed. There was a delay in placing the patient on a cardiac monitor and performing a physical examination. The facility failed to ensure that their own policy and procedure was followed as evidenced by failing to provide a medical screening examination appropriate to the patients presenting signs and symptoms and the capacity and capability of the hospital as stated in the facility’s policy. During an interview on 01/08/2025 at 10:06 AM with Staff G/ Patient Safety Manager, she stated based on the timeline from the medical record review, we discovered the areas for improvement include the EKG and vital signs should have been completed on arrival, someone should have responded to complete the EKG when ordered, “Due to competing priorities in the main emergency room, the importance of the EKG and the vital signs was not prioritized appropriately”. During an interview on 01/08/2025 11:53 AM with Staff H/VP Emergency Services, she stated the protocol and standard is when a patient checks in with chest pain, an EKG and vital signs are taken within 10 minutes of arrival. It was an extremely busy night with very high acuity level patients, and we were also holding 22 admission patients in the main ED. When the patient checked in, we did not have an open bed to place him in and when the PCT went to perform his EKG, the PCT got a phone call to come to the back (main ED) to help with another patient. So, the EKG was never done. On 01/16/2025 at 11:15 AM, 01/17/2025 at 16:20 PM, and on 01/20/2025 at 10:00 AM, an interview was attempted via phone call with the ED Medical Director and voicemail left each time, no phone call back. The facility completed their Corrective Action Plan (CAP) on 01/03/2025. Review of the CAP included additional RN role assigned to the waiting room and education on the role and responsibilities, role and responsibilities to staff assigned to perform EKG’s and vital signs in the waiting room, reimplementing Zones 1, 2, 3 (Zone 1 patients that have checked in but have not been triaged, Zone 2 after a patient has been triaged, and Zone 3 patients who are stable and waiting for discharge) for patient identification and location in the waiting room and surge scenarios are conducted daily with the ER Director and/or Managers. Employees were required to acknowledge education with a sign in sheet. On 01/09/2025, evidence of the above was verified by review of the education sign in sheets, interviews conducted with the staff of the ED and tour of the Emergency Room waiting room. The plan of correction was found to be in place and 100% completed. Education provided included “Care of the Patient Presenting with Chest Pain in the ED”, “ED Waiting Room Zones and Process for Patient Flow”, “Process for Internal Activation for Code Blue”, ED Waiting Room: Roles and Responsibilities of RN assigned to the Waiting Room and EKG PCT and Policy’s included Assessment/Reassessment, ED Patient Standards of Care and Code Blue.”

“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 review of medical records, policies and interviews, the hospital failed to: 1) Act upon a change in condition and escalate the notification process to a physician, and activation of a stroke alert resulting in the death of Patient #3 and; 2) Ensure IV (intravenous) seizure medication was given in a safe manner for status epilepticus to Patient #4, resulting in the death of Patient #4. Refer to A144 Standard On 11/18/2024, the facility presented a plan of correction for removal of immediacy. The actions included: 100% of working Critical Care RN staff have been educated on the following policies: bedside shift report, appropriateness of orders and acknowledgement of orders, neuro changes signs / symptoms, and chain of command / escalation and manage / refer / contact / notify documentation. Additional hospital wide education and policy review includes documentation of assessment/reassessment for a change in condition, where to chart the change in condition and policy review and re-education on text messaging with medical staff. Additional education will continue until 100% signatures acquired. Additionally, auditing medical records for neuro checks and the medication Dilantin has begun and will continue. Limited numbers of Dilantin (seizure medication) vials will be available in the medication dispensing machine. Medication Dispensing machine will alert the individual trying to remove more than two vials of Dilantin. These items were verified by observation and review of education material, sign-off sheets and interviews with staff.”

“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 review of facility corrective action plan, medical records and interviews, the hospital failed to ensure a complete and thorough investigation and analysis was completed, and an adequate corrective action plan was implemented to prevent additional serious events, after Patient #3 died from a change of condition that was not acted upon, and Patient #4 died as a result of IV push medication given incorrectly. Refer to A0286 Standard, A0273 Standard and A0283 Standard. On 11/18/2024, the facility presented a plan of correction for removal of immediacy. The actions included: 100% of working Critical Care RN staff have been educated on the following policies: bedside shift report, appropriateness of orders and acknowledgement of orders, neuro changes signs / symptoms, and chain of command / escalation and manage / refer / contact / notify documentation. Additional hospital wide education and policy review includes documentation of assessment/reassessment for a change in condition, where to chart the change in condition and policy review and re-education on text messaging with medical staff. Additional education will continue until 100% signatures acquired. Additionally, auditing medical records for neuro checks and the medication Dilantin has begun and will continue. Limited numbers of Dilantin (seizure medication) vials will be available in the medication dispensing machine. Medication Dispensing machine will alert the individual trying to remove more than two vials of Dilantin. These items were verified by observation and review of education material, sign-off sheets and interviews with staff.”

“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: 48190 The hospital failed to ensure medical staff responded and assessed a patient when made aware of the change in neurological condition for 1 patient (Patient #3) of 3 deaths reviewed. Findings included: Review of the medical record for Patient #3 revealed an arrival by ambulance on 10/1/24 at approximately 4:00 AM, with a chief complaint of left sided weakness. Upon arrival he was found to be unresponsive and was intubated. A CT (computed tomography-imaging) of the brain was completed and revealed he had a right middle cerebral artery (MCA) thrombosis, known as a large vessel occlusion (blood clot/stroke). Interventional radiology was consulted and an emergent thrombectomy was performed (a procedure where a retrieval device is passed through a large blood vessel and guided to the brain where the blood clot is located and removed). The post procedural orders included frequent neuro checks; after 2 hours, neuro checks were hourly. (neuro checks are assessments of neurological function that include things like reflexes, pupil response and size). At approximately 8:30 AM he was sent to the ICU (Intensive Care Unit), where Staff A, RN (registered nurse) was assigned to care for him. At that time his nursing assessment reflected pupil size bilaterally (both eyes) were equal and reactive at 2 mm (millimeters). Hourly neuro checks continued with no changes until 1:00 PM. There were no further neuro checks documented until 4:00 PM, which were unchanged. The next documented neuro check was at 8:00 PM, after shift change. Staff G, RN completed his assessment and documented the left pupil was 2 mm and responsive. She documented the right pupil was 6 mm and fixed and dilated. Staff G, RN continued hourly neuro checks, and they were unchanged until 12:00 AM 10/2/24, where she noted the left pupil was 4mm and the right was 6 mm, both fixed and dilated. The pupillary assessments were documented hourly, and at 4:00 AM they were noted to both be 6 mm, fixed and dilated, and remained that way for hourly neuro checks into the oncoming shift at 7 AM. On 10/1/24 at 11:00 PM, a nursing note entered by Staff B, RN reflected a physician was notified of the pupil change and rescheduled the CT for an earlier time in the morning. He noted that a respiratory therapist was not available to take the patient to CT scan at the scheduled time. Review of the medical record revealed no assessment by the medical staff was done, nor was a Stat (immediate) CT ordered on Patient #3. The CT scan ordered on 10/1/24 at 11:56 PM was scheduled for 10/2/24 at 5:00 AM. That CT was cancelled at 11:57 PM, and another CT was ordered for 7 AM on 10/2/24. That CT was cancelled, and another CT was ordered for 8:45 AM on 10/2/24. On 10/2/24 at 8:30 AM a stat CT was ordered. These findings were confirmed by Staff T, Director of Clinical Informatics during the record review on 11/13/24 at approximately 11:58 AM. On 10/2/2024 at 6:52 AM, 7 hours and 52 minutes after initial notification, the Resident Physician’s progress note revealed that he noted that the physical exam was significantly worse with no gag reflex, cough reflex, or corneal response (eye response). On 10/2/2024 at 7:26 AM the Physician’s progress note revealed “sometime overnight the patient’s eyes became fixed and dilated. Upon exam this morning he was sent for a stat MRI, (with the findings above documented). Neurosurgery was consulted emergently and saw the patient and said there was nothing they could do. Further exam showed the patient did not have any brainstem reflexes. The situation was discussed with his wife, who wants him to remain on life support so family can gather.” On 10/2/2024 at 9:17 AM the Neurology progress note revealed “there were no documented neurological changes overnight. The bedside RN this morning received report of neurological changes overnight, and it does not appear critical care staff were notified. The patient has no reflexes and does not respond to painful stimuli. He is not on any sedation. He is experiencing decerebrate posturing (an involuntary abnormal body position that is a sign of severe brain damage) with noxious stimuli.” On 10/2/2024 at 12:41 the Neurosurgeon consult note revealed “Per ICU team, patient has had an enlarged nonreactive pupil since around midnight. On exam, does not show any residual brain reflexes. This is a devastating injury, and I do not recommend neurosurgery in the setting of dismal exam. Findings shared with wife at bedside.” Review of the expiration record dated 10/5/2024 revealed a primary diagnosis of massive catastrophic CVA (cerebrovascular accident/stroke) with hemorrhagic conversion (bleeding), and evidence of brain death. After final neurological exam he was transferred to [organ donation]. Review of the Stroke Alert policy, 6/3/24, reflected the following: Scope: All Health care providers at HCA Florida Brandon Hospital who are providing care to and/or managing the patients that are identified as having symptoms of a suspected or known acute stroke. Purpose: To provide guidelines for initiating a stroke alert. To establish care guidelines for patients presenting with stroke symptoms. To delineate the roles of the stroke team during and immediately after a stroke alert is called. A stroke alert is called when a patient is exhibiting signs of a stroke. The stroke team along with the nurse providing care for the patient follow an established algorithm in order to provide a diagnosis and treatment plan in an expedited manner. During a telephone interview on 11/13/2024 at 8:59 AM, Staff B, RN (night shift) said “when we came on shift the right pupil was 6 mm, the left was 2 mm. We didn’t know it was a change. So, when the physician came in to do rounds, we let him know.” The doctor didn’t go in the room to assess the patient after he was told. He rescheduled the CT scan from 7 AM to 5 AM. “The assessment is discussed, but when I got report, I was trying to fix the OG (oral-gastric) tube because it was on suction and there was blood coming out of it. It was on regular suction, so I lowered it to low intermittent suction because that was the order. We did not do the shift report together because of that. The change in pupils had to have happened between 1PM and 7PM. The nurse said she was told somebody called her and told her she could stop the neuro checks. I was never aware that it was a change.” During an interview on 11/13/2024 at 10:20 AM, Staff I, MD (Intensivist) said he has no recollection the nurse notified him of a change with the patient. “I have a very good memory. I would have remembered if I was notified. He may have told a Resident.” During an interview on 11/13/2024 at 10:35 AM, Staff S, RN ICU (Intensive Care Unit) said “We do bedside report. Look at the patient. Do a neuro assessment together at the bedside. I would notify the Resident and the intensivist to ask for a stroke alert and take the patient straight to CT.” During an interview on 11/13/2024 at 10:38 AM, Staff R, Director of Critical Care said she did participate in the investigation. Staff I, MD was present during rounds and was notified by the nurse. During a telephone interview on 11/13/2024 at 2:04 PM, Staff E, Resident Physician said “I don’t think I was notified about it. Someone else may have been notified. The patient will have a follow up CT in the morning after a procedure like that. I was not notified of any neurologic change for the patient. I don’t think the communication was there.” During a telephone interview on 11/13/2024 at 5:30 PM, Staff D, Resident Physician said “We have three residents on at night. We stay awake all night. Nursing reaches out to us. I don’t recall any notification. I would have gotten a stat CT. The only reason I wouldn’t order it stat is if it wasn’t a change in the patient’s condition. I may have rounded on him. I don’t know why I would have cancelled the CT. This was during overnight rounds. It should have been a stat CT scan. There would have been a repeat post thrombectomy CT in the morning. Nurses are the bigger bridge and see the neurologic changes. Unless we were alerted, we wouldn’t go in and assess the patient. The nurses are the ones doing the neuro checks. When critical care does nightly rounds from 9 to 12, often the orders are put in by one person. The attending may have told me to cancel the CT. That’s the only thing I can think of.” On 11/18/2024, the facility presented a plan of correction for removal of immediacy. The actions included: 100% of working Critical Care RN staff have been educated on the following policies: bedside shift report, appropriateness of orders and acknowledgement of orders, neuro changes signs / symptoms, and chain of command / escalation and manage / refer / contact / notify documentation. Additional hospital wide education and policy review includes documentation of assessment/reassessment for a change in condition, where to chart the change in condition and policy review and re-education on text messaging with medical staff. Additional education will continue until 100% signatures acquired. Additionally, auditing medical records for neuro checks and the medication Dilantin has begun and will continue. Limited numbers of Dilantin (seizure medication) vials will be available in the medication dispensing machine. Medication Dispensing machine will alert the individual trying to remove more than two vials of Dilantin. These items were verified by observation and review of education material, sign-off sheets and interviews with staff.”

“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: 36678 Based on review of medical records, interviews, and policies, the hospital failed to: 1) Identify a change in condition and active a stroke alert, escalate the notification process to a physician resulting in the death of Patient #3, and prevent a medication error that resulted in the death of Patient #3. Refer to A0398 Standard. 2) ensure the administration of IV (intravenous) medication in a safe manner in one (#4) of three expired patients. Refer to A0410 Standard. On 11/18/2024, the facility presented a plan of correction for removal of immediacy. The actions included: 100% of working Critical Care RN staff have been educated on the following policies: bedside shift report, appropriateness of orders and acknowledgement of orders, neuro changes signs / symptoms, and chain of command / escalation and manage / refer / contact / notify documentation. Additional hospital wide education and policy review includes documentation of assessment/reassessment for a change in condition, where to chart the change in condition and policy review and re-education on text messaging with medical staff. Additional education will continue until 100% signatures acquired. Additionally, auditing medical records for neuro checks and the medication Dilantin has begun and will continue. Limited numbers of Dilantin (seizure medication) vials will be available in the medication dispensing machine. Medication Dispensing machine will alert the individual trying to remove more than two vials of Dilantin. These items were verified by observation and review of education material, sign-off sheets and interviews with staff.”

“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, interviews, and policy review the hospital failed to: 1) identify a change in condition and provide emergency medical care, services, and treatment for a stroke patient in the ICU resulting in brain death in 1(Patient #3) of 3 expired patients reviewed and; 2) ensure IV (Intravenous) seizure medication was administered safely in accordance with accepted standards of nursing practice in 1 (Patient #4) of 3 expired patients reviewed. Findings included: 1. Review of the medical record for Patient #3 revealed he arrived by ambulance on 10/1/2024 at approximately 4:00 AM with a chief complaint of left sided weakness. Upon arrival he was found to be unresponsive, and was intubated (a medical procedure that involves inserting a tube into a patient’s body, usually through the mouth or nose, to help them breathe or deliver medication) to protect his airway. A CT (computed tomography-imaging) of the brain was completed and revealed he had a right middle cerebral artery (MCA) thrombosis, known as a large vessel occlusion (blood clot/stroke). Interventional Radiology was consulted and an emergent thrombectomy was performed (a procedure where a retrieval device is passed through a large blood vessel and guided to the brain where the blood clot is located and removed). The post procedural orders included frequent neurological (neuro) checks. After 2 hours, neuro checks were to be done hourly (neuro checks are assessments of neurological function that include things like reflexes, pupil response and size). At approximately 8:30 AM, Patient #3 was sent to the ICU (Intensive Care Unit), where Staff A, RN (Registered Nurse) was assigned to care for him. The nursing assessment reflected pupil size bilaterally (both eyes) were equal and reactive at 2 mm (millimeters). Hourly neuro checks continued with no changes until 1:00 PM. There were no further neuro checks documented until 4:00 PM, which were unchanged. The next documented neuro check was at 8:00 PM, after shift change. Staff G, RN completed his assessment and documented the left pupil was 2 mm and responsive and the right pupil was 6 mm and fixed and dilated. Staff G, RN continued hourly neuro checks and they were unchanged until 12:00 AM 10/2/2024, she noted the left pupil was 4 mm and the right was 6 mm, both fixed and dilated. The pupillary assessments were documented hourly, and at 4:00 AM they were noted to both be 6 mm, fixed and dilated, and remained that way for hourly neuro checks into the oncoming shift at 7 AM. A nursing note entered by Staff B, RN at 11:00 PM on 10/1/2024 revealed a physician was notified of the pupil change and rescheduled the CT for an earlier time in the morning. He noted that a respiratory therapist was not available to take the patient to CT scan at the scheduled time. There were no further notes indicating a physician was notified of the progressive changes documented in Staff G, RN’s assessments. There was no documentation a stroke alert (a protocol for identifying stroke symptoms) being called for any of the documented changes. This was confirmed by Staff T, Director of Clinical Informatics during the record review on 11/12/2024 at approximately 11:39 AM. Review of physician’s order in the medical record revealed there was not an order to discontinue neuro checks. On 10/1/2024 at 11:56 PM, the physician ordered a scheduled CT scan for 5:00 AM on 10/2/2024. The CT was canceled at 11:57 PM, and another CT was ordered for 7 AM on 10/2/2024. That CT was canceled, and another CT was ordered for 8:45 AM on 10/2/2024. On 10/2/2024 at 8:30 AM a stat CT was ordered. These findings were confirmed by Staff T, Director of Clinical Informatics during the record review on 11/13/2024 at approximately 11:58 AM. On 10/2/2024 at 6:52 AM the Resident Physician’s progress note revealed “a repeat CT and MRI [Magnetic Resonance Imaging- a non-invasive medical imaging technique that uses radio waves and a strong magnetic field to create detailed pictures of the inside of the body] of the brain were completed with findings of large evolving right MCA infarction [tissue death]. Effacement of sulci and gyri in right cerebral hemisphere, marked mass effect on right lateral ventricle which is effaced. Midline shift from left to right of 2.2 cm. Increase of size of left ventricle. Areas of hemorrhage present within the infarct.” [see interpretation below] He noted that the physical exam was significantly worse with no gag reflex, cough reflex, or corneal response (eye response). On 10/2/2024 at 7:26 AM the Physician’s progress note revealed “sometime overnight the patient’ s eyes became fixed and dilated. Upon exam this morning he was sent for a stat MRI, [with the findings above documented]. Neurosurgery was consulted emergently and saw the patient and said there was nothing they could do. Further exam showed the patient did not have any brainstem reflexes. The situation was discussed with his wife, who wants him to remain on life support so family can gather.” On 10/2/2024 at 9:17 AM the Neurology progress note revealed “there were no documented neurological changes overnight. The bedside RN this morning received report of neurological changes overnight, and it does not appear critical care staff were notified. The patient has no reflexes and does not respond to painful stimuli. He is not on any sedation. He is experiencing decerebrate posturing [an involuntary abnormal body position that is a sign of severe brain damage] with noxious stimuli.” On 10/2/2024 at 12:41 the Neurosurgeon consult note revealed “Per ICU team, patient has had an enlarged nonreactive pupil since around midnight. On exam, does not show any residual brain reflexes. This is a devastating injury, and I do not recommend neurosurgery in the setting of dismal exam. Findings shared with wife at bedside.” Review of the expiration record dated 10/5/2024 revealed a primary diagnosis of massive catastrophic CVA (cerebrovascular accident/stroke) with hemorrhagic conversion (bleeding), and evidence of brain death. After final neurological exam he was transferred to [organ donation status]. During an interview on 11/12/2024 at 2:12 PM, Staff A, RN stated she got a text message on the hospital phone from the nurse practitioner stroke coordinator telling her she needed to finish the neuro checks up to 1:00 PM. Staff A, RN then asked if she needed to continue the neuro checks after that and got a text message back saying ‘no’. “I was under the impression she was auditing my documentation and letting me know I needed to complete it because I don’t always document in real time. Sometimes it’s later. She messaged me to continue neuro checks for 3 hours and I asked do we need to continue after that, and she said no. He was not any different at hand off than when I received him. I still assessed him, I just stopped charting it.” During a telephone interview on 11/13/2024 at 8:59 AM, Staff B, RN (night shift) said “when we came on shift the right pupil was 6 mm, the left was 2 mm. We didn’t know it was a change. So, when the physician came in to do rounds, we let him know.” The doctor didn’t go in the room to assess the patient after he was told. He rescheduled the CT scan from 7 AM to 5 AM. “The assessment is discussed, but when I got report, I was trying to fix the OG (oral-gastric) tube because it was on suction and there was blood coming out of it. It was on regular suction, so I lowered it to low intermittent suction because that was the order. We did not do the shift report together because of that. The change in pupils had to have happened between 1PM and 7PM. The nurse said she was told somebody called her and told her she could stop the neuro checks. I was never aware that it was a change.” During an interview on 11/13/2024 at 10:20 AM, Staff I, MD said he has no recollection the nurse notified him of a change with the patient. “I have a very good memory. I would have remembered if I was notified. He may have told a Resident.” During an interview on 11/13/24 at 10:35 AM, Staff S, RN ICU (Intensive Care Unit) stated “We do bedside report. Look at the patient. Do a neuro assessment together at the bedside. I would notify the Resident and the Intensivist to ask for a stroke alert and take the patient straight to CT.” During an interview on 11/13/2024 at 10:38 AM, Staff R, Director of Critical Care stated she did participate in the investigation. Staff I, MD was present during rounds and was notified by the nurse. During a telephone interview on 11/13/2024 at 10:54 AM, Staff H, APRN (Advanced Practice Registered Nurse) stated “We send out drill downs of required assessments per the comprehensive stroke program. I told her to continue the neuro checks. I recall telling her we needed the required neuro checks for the program. I don’t remember telling her to discontinue the neuro checks.” During a telephone interview on 11/13/24 at 2:04 PM, Staff E, Resident physician stated “I don’t think I was notified about it. Someone else may have been notified. The patient will have a follow up CT in the morning after a procedure like that. I was not notified of any neurologic change for the patient. I don’t think the communication was there.” During a telephone interview on 11/13/2024 at 5:30 PM, Staff D, Resident physician stated “We have three residents on at night. We stay awake all night. Nursing reaches out to us. I don’t recall any notification. I would have gotten a stat CT. The only reason I wouldn’t order it stat is if it wasn’t a change in the patient’s condition. I may have rounded on him. I don’t know why I would have canceled the CT. This was during overnight rounds. It should have been a stat CT scan. There would have been a repeat post thrombectomy CT in the morning. Nurses are the bigger bridge and see the neurologic changes. Unless we were alerted, we wouldn’t go in and assess the patient. The nurses are the ones doing the neuro checks. When critical care does nightly rounds from 9 to 12, often the orders are put in by one person. The attending may have told me to cancel the CT. That’s the only thing I can think of.” During a group interview on 11/14/2024 at 1:15 PM, the Director of Patient Safety, the Director of Quality, the Assistant Chief Nursing Officer (ACNO), the Director of Respiratory/Cardiopulmonary, the Patient Safety Coordinator, and by video conference Staff G, RN, Staff A, RN, the Vice President of Operations, and Staff V, Director of Critical Care were all present. Staff G, RN said she was on orientation at that time. “We got report from the morning nurse. She confirmed from the stroke coordinator that neuro checks were stopped at 1:00PM. We assessed the patient and noticed the pupils were unequal in size. During the rounds with the doctors, we informed them about the findings. The attending, Staff I, Residents, the Charge Nurse, and the Nurse assigned to the patient participate in rounds. There was a repeat CT scan scheduled for 5 AM. It was originally scheduled for 10 AM. I told the Respiratory Therapist (RT) through messaging that we had a CT order. She said she was not available, and so we asked for a later time, and she said she still couldn’t do it and wasn’t available to do it until after her shift. We were unable to do a CT scan on our shift. If it was stat [immediate] we would have to escalate to the charge and see if there is another RT available to help us. I don’t think the Physician was aware that it couldn’t be done at that time.” Staff A, RN said “I received a message from the Nurse Practitioner asking about the neuro checks and I messaged her if she wanted us to continue the neuro checks. She said no. I do not recall if she put the order in.” The providers have to put their own orders in. Not the nurse. The Director of Cardiopulmonary/Respiratory Services said scheduling is based on the census. There are usually 6 to 8 Respiratory Therapists during the day. 1 to 2 less on the night shift. “We go by a point scale. We go by what procedures the patients are on. I would never say we are not going to a CT. A routine scan, they would try to work with the nurse on coordinating the time. A stat they would be available.” Review of the Stroke Alert policy, 6/3/24, reflected the following: Scope: All Health care providers at HCA Florida Brandon Hospital who are providing care to and/or managing the patients that are identified as having symptoms of a suspected or known acute stroke. Purpose: To provide guidelines for initiating a stroke alert. To establish care guidelines for patients presenting with stroke symptoms. To delineate the roles of the stroke team during and immediately after a stroke alert is called. A stroke alert is called when a patient is exhibiting signs of a stroke. The stroke team along with the nurse providing care for the patient follow an established algorithm in order to provide a diagnosis and treatment plan in an expedited manner. All patients are managed according to American Heart Association Guidelines. Review of the policy, Assessment and Reassessment, 4/24/23, revealed the following: Scope: All hospital caregivers and medical staff. Nursing Units-Policy: Any change in the patient’s condition shall require an immediate reassessment with changes in the plan of care reflecting the change of condition. 2. Review of Patient #4’s medical record nursing assessment revealed that on 10/16/2024 at 8:00 AM Staff K, RN documented the patient shift assessment. On 11/16/2024 at 3:43 PM Staff H, APRN ordered a loading dose of Dilantin (seizure medication) 950 mg IV (intravenous) with a maximum dose of 50 mg/minute (19-20 minutes to infuse). The electronic medication administration record (eMAR) revealed that Staff K, RN administered the medication IV push (a process of introducing a medication substance directly into the bloodstream at a rapid pace) at 4:00 PM. On 10/16/2024 the Critical Care noted showed Staff L, APRN arrived to the bedside with the attending physician, and the patient was unresponsive with noxious (painful) stimuli, apneic (temporarily stops breathing) and severe bradycardic (slow heartbeat less than 40 minute) and unable to obtain a blood pressure. Per the note the loading dose of Dilantin was administered prior to arrival into the room. Moments later Patient #4 became pulseless and asystolic (electrical activity in the heart stops and the heart stop pumping). She did not survive. Review of the consent for Disposition of Body for Patient #4 showed the patients weight is 62.1kg and she expired on 10/16/2024 at 4:09 PM. Patient #4’s medical record revealed that Staff K RN did not document the incident in the medical record. During an interview on 11/12/2024 at 1:20 PM, Staff Q, Clinical Coordinator stated that the nurse did not document the event in the medical record and should have.”

“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 facility documents, medical records and interviews, the facility failed to ensure a thorough investigation was completed for two serious events involving 2 (Patient #3, and Patient #4) of 2 mortality medical records reviewed. Findings included: Review of the medical record for Patient #3 revealed an arrival by ambulance on 10/1/2024 at approximately 4:00 AM, with a chief complaint of left sided weakness. Upon arrival he was found to be unresponsive, not protecting his airway and was intubated (a medical procedure that involves inserting a tube into a patient’s body, usually through the mouth or nose, to help them breathe or deliver medication). A CT (computed tomography-imaging) of the brain was completed and revealed he had a right middle cerebral artery (MCA) thrombosis, known as a large vessel occlusion (blood clot/stroke). Interventional radiology was consulted and an emergent thrombectomy was performed (a procedure where a retrieval device is passed through a large blood vessel and guided to the brain where the blood clot is located and removed). The post procedural orders included frequent neuro checks; after 2 hours, neuro checks were hourly. (neuro checks are assessments of neurological function that include things like reflexes, pupil response and size). At approximately 8:30 AM he was sent to the ICU (Intensive Care Unit), where Staff A, RN (Registered Nurse) was assigned to care for him. The nursing assessment reflected pupil size bilaterally (both eyes) were equal and reactive at 2 mm (millimeters). Hourly neuro checks continued with no changes until 1:00 PM. There were no further neuro checks documented until 4:00 PM, which were unchanged. The next documented neuro check was at 8:00 PM, after shift change. Staff G, RN completed his assessment and documented the left pupil was 2 mm and responsive and the right pupil was 6 mm and fixed and dilated. Staff G, RN continued hourly neuro checks and they were unchanged until 12:00 AM 10/2/2024, she noted the left pupil was 4mm and the right was 6 mm, both fixed and dilated. The pupillary assessments were documented hourly, and at 4:00 AM they were noted to both be 6 mm, fixed and dilated, and remained that way for hourly neuro checks into the oncoming shift at 7 AM. On 10/1/24 at 11:00 AM, a nursing note entered by Staff B, RN revealed a physician was notified of the pupil change and rescheduled the CT for an earlier time in the morning. He noted that a respiratory therapist was not available to take the patient to CT scan at the scheduled time. Review of physician’s order in the medical record revealed there was not an order to discontinue neuro checks. On 10/1/2024 at 11:56 PM, the physician ordered a scheduled CT scan for 5:00 AM on 10/2/2024. The CT was cancelled at 11:57 PM, and another CT was ordered for 7 AM on 10/2/2024. That CT was cancelled, and another CT was ordered for 8:45 AM on 10/2/2024. On 10/2/2024 at 8:30 AM a stat CT was ordered. These findings were confirmed by Staff T, Director of Clinical Informatics during the record review on 11/13/2024 at approximately 11:58 AM. There were no further notes indicating a physician was notified of the progressive changes documented in Staff G, RN’s assessments. There was no documentation a stroke alert (a protocol for identifying stroke symptoms) being called for any of the documented changes. This was confirmed by Staff T, Director of Clinical Informatics during the record review on 11/12/2024 at approximately 11:39 AM. On 10/2/2024 at 6:52 AM the Resident Physician’s progress note revealed “a repeat CT and MRI (Magnetic Resonance Imaging- a non-invasive medical imaging technique that uses radio waves and a strong magnetic field to create detailed pictures of the inside of the body.) of the brain were completed with findings of large evolving right MCA infarction (tissue death). Effacement of sulci and gyri in right cerebral hemisphere, marked mass effect on right lateral ventricle which is effaced. Midline shift from left to right of 2.2 cm. Increase of size of left ventricle. Areas of hemorrhage present within the infarct. (see interpretation below) He noted that the physical exam was significantly worse with no gag reflex, cough reflex, or corneal response (eye response).” On 10/2/2024 at 7:26 AM the Physician’s progress note revealed “sometime overnight the patient’ s eyes became fixed and dilated. Upon exam this morning he was sent for a stat MRI, (with the findings above documented). Neurosurgery was consulted emergently and saw the patient and said there was nothing they could do. Further exam showed the patient did not have any brainstem reflexes. The situation was discussed with his wife, who wants him to remain on life support so family can gather.” On 10/2/2024 at 9:17 AM the Neurology progress note revealed “there were no documented neurological changes overnight. The bedside RN this morning received report of neurological changes overnight, and it does not appear critical care staff were notified. The patient has no reflexes and does not respond to painful stimuli. He is not on any sedation. He is experiencing decerebrate posturing (an involuntary abnormal body position that is a sign of severe brain damage) with noxious stimuli.” On 10/2/2024 at 12:41 the Neurosurgeon consult note revealed “Per ICU team, patient has had an enlarged nonreactive pupil since around midnight. On exam, does not show any residual brain reflexes. This is a devastating injury, and I do not recommend neurosurgery in the setting of dismal exam. Findings shared with wife at bedside.” Review of the expiration record dated 10/5/2024 revealed a primary diagnosis of massive catastrophic CVA (cerebrovascular accident/stroke) with hemorrhagic conversion (bleeding), and evidence of brain death. After final neurological exam he was transferred to Life Link. Review of Patient #4’s medical record revealed on 10/02/2024 at 4:34 PM Staff H, APRN (Advanced Practice Registered Nurse) ordered Dilantin 750 mg (milligrams) (15 mg/kg-kilogram) once to infuse over 5 minutes, max rate 50 mg/minute. The order was discontinued by pharmacy. Order clarified and rewritten with a verbal order. A new order was entered Dilantin 750 mg (Dilantin 250 mg/ ml vial) sodium chloride 100 ml -milliliters (1 bag fluid) to infuse at 345 ml /hour. On 10/16/2024 at 3:43 PM Staff H, ARNP ordered Dilantin with an increased dose to 950 mg (15 mg/kg) to infuse at a rate of 50 mg/minute (19-20 minutes to infuse). Review of the eMAR (electronic Medication Administration Record) Staff K, RN administered the Dilantin IV (intravenous) push (a process of introducing a medication substance directly into the bloodstream at a rapid pace) on 10/16/2024 at 4:00 PM. Review of the consent for Disposition of Body for Patient #4 showed the patients weight is 62.1kg and she expired on 10/16/2024 at 4:09 PM. No further documentation was noted in the medical record related to Patient #4’s condition. During an interview on 11/14/2024 at 9:28 AM, Staff N (offsite Pharmacist) stated she reviewed the Dilantin order, and she assumed the medication was to be given with a saline bag. Staff N did not clarify the order with Staff H, ARNP. During an interview on 11/12/2024 at 2:12 PM, Staff A, RN stated she got a text message on the hospital phone from the nurse practitioner stroke coordinator telling her she needed to finish the neuro checks up to 1:00 PM. Staff A, RN then asked if she needed to continue the neuro checks after that and got a text message back saying ‘no’. “I was under the impression she was auditing my documentation and letting me know I needed to complete it because I don’ t always document in real time. Sometimes it’ s later. She messaged me to continue neuro checks for 3 hours and I asked do we need to continue after that, and she said no. He was not any different at hand off than when I received him. I still assessed him, I just stopped charting it.” During a telephone interview on 11/13/2024 at 8:59 AM, Staff B,RN (night shift) said “when we came on shift the right pupil was 6 mm, the left was 2 mm. We didn’t know it was a change. So, when the physician came in to do rounds, we let him know.” The doctor didn’t go in the room to assess the patient after he was told. He rescheduled the CT scan from 7 AM to 5 AM. “The assessment is discussed, but when I got report, I was trying to fix the OG (oral-gastric) tube because it was on suction and there was blood coming out of it. It was on regular suction, so I lowered it to low intermittent suction because that was the order. We did not do the shift report together because of that. The change in pupils had to have happened between 1PM and 7PM. The nurse said she was told somebody called her and told her she could stop the neuro checks. I was never aware that it was a change.” During an interview on 11/13/2024 at 9:30 AM, Staff U, Stroke Coordinator stated the record did not go for Peer review. The peer review coordinator was made aware. During an interview on 11/13/2024 at 10:20 AM, Staff I, MD said he has no recollection the nurse notified him of a change with the patient. “I have a very good memory. I would have remembered if I was notified. He may have told a Resident.” During an interview on 11/13/24 at 10:35 AM, Staff S, RN ICU (intensive care unit) stated “We do bedside report. Look at the patient. Do a neuro assessment together at the bedside. I would notify the Resident and the intensivist to ask for a stroke alert and take the patient straight to CT.” During an interview on 11/13/2024 at 10:38 AM, Staff R, Director of Critical Care stated she did participate in the investigation. Staff I, MD was present during rounds and was notified of the change by the nurse. During a telephone interview on 11/13/2024 at 10:54 AM, Staff H, APRN stated “We send out drill downs of required assessments per the comprehensive stroke program. I told her to continue the neuro checks. I recall telling her we needed the required neuro checks for the program. I don’t remember telling her to discontinue the neuro checks.” During a telephone interview on 11/13/24 at 2:04 PM, Staff E, Resident physician stated “I don’t think I was notified about it. Someone else may have been notified. The patient will have a follow up CT in the morning after a procedure like that. I was not notified of any neurologic change for the patient. I don’t think the communication was there.” During a telephone interview on 11/13/2024 at 5:30 PM, Staff D, Resident physician stated “We have three residents on at night. We stay awake all night. Nursing reaches out to us. I don’t recall any notification. I would have gotten a stat CT. The only reason I wouldn’t order it stat is if it wasn’t a change in the patient’s condition. I may have rounded on him. I don’t know why I would have cancelled the CT. This was during overnight rounds. It should have been a stat CT scan. There would have been a repeat post thrombectomy CT in the morning. Nurses are the bigger bridge and see the neurologic changes. Unless we were alerted, we wouldn’t go in and assess the patient. The nurses are the ones doing the neuro checks. When critical care does nightly rounds from 9 to 12, often the orders are put in by one person. The attending may have told me to cancel the CT. That’s the only thing I can think of.” During an interview on 11/14/24 at 12:32 PM, the CEO (Chief Executive Officer) stated they would “not provide nor discuss their investigation, analysis, and corrective action plan. It’s legally protected PSO [Patient Safety Organization] information.” During a group interview on 11/14/24 at 1:15 PM, the Director of Patient Safety, the Director of Quality, the Assistant Chief Nursing Officer (ACNO), the Director of Respiratory/Cardiopulmonary Services, the Patient Safety Coordinator, and by video conferencing Staff G, RN, Staff A, RN, the VP (Vice President) of Operations, and Staff V, Director of Critical Care were all present. Staff G, RN said she was on orientation at that time. “We got report from the morning nurse. She confirmed from the stroke coordinator that neuro checks were stopped at 1:00PM. We assessed the patient and noticed the pupils were unequal in size. During the rounds with the doctors, we informed them about the findings. The attending [Physician], Staff I, Residents, the charge nurse, and the nurse assigned to the patient participate in rounds. There was a repeat CT scan for 5 AM. It was originally scheduled for 10 AM. I told the Respiratory Therapist (RT) through messaging that we had a CT order. She said she was not available, and so we asked for a later time, and she said she still couldn’t do it, and wasn’t available to do it until after her shift. We were unable to do a CT scan on our shift. If it was stat we would have to escalate to the charge and see if there is another RT available to help us. I don’t think the physician was aware that it couldn’t be done at that time.” Staff A, RN stated “I received a message from the Nurse Practitioner asking about the neuro checks and I messaged her if she wanted us to continue the neuro checks. She said no. I do not recall if she put the order in.” The providers have to put their own orders in. Not the nurse. The Director of Respiratory/Cardiopulmonary Services said scheduling is based on the census. There are usually six to eight Respiratory Therapists during the day. One to two less on the night shift. “We go by a point scale. We go by what procedures the patients are on. I would never say we are not going to a CT. A routine scan, they would try to work with the nurse on coordinating the time. A stat they would be available.” Review of facility documents revealed no evidence the nurses, medical staff and pharmacists were provided education for the preparation and administration of the medication Dilantin. No evidence was provided the providers received education on how to report an issue with the order set. No evidence was provided the nursing staff received education when documenting a change in the patient’s condition. No evidence was provided an investigation and analysis was completed.”

“QUALITY IMPROVEMENT ACTIVITIES CFR(s): 482.21(b)(2)(ii), (c)(1), (c)(3) (b) Program Data (2) [The hospital must use the data collected to - .....] (ii) Identify opportunities for improvement and changes that will lead to improvement. (c) Program Activities (1) The hospital must set priorities for its performance improvement activities that-- (i) Focus on high-risk, high-volume, or problem-prone areas; (ii) Consider the incidence, prevalence, and severity of problems in those areas; and (iii) Affect health outcomes, patient safety, and quality of care. (3) The hospital must take actions aimed at performance improvement and, after implementing those actions, the hospital must measure its success, and track performance to ensure that improvements are sustained. This Standard is not met as evidenced by: 36678 Based on review of facility corrective action plans, medical records, policy review, and interviews, the hospital failed to ensure the QAPI (Quality Assurance Performance Improvement) program implemented a thorough and effective corrective action plan for: 1) an adverse medication event that resulting in death for 1 (Patient #4) of 3 patients sampled including areas of opportunities for pharmacy clarification of provider medication orders and putting a corrective action in place to prevent another serious event. 2) a serious event for 1 (Patient #3) of 3 stroke patients sampled, addressing all root causes, and education to all staff. Findings included: 1. Review of facility Corrective Action Plan submitted to the Agency for Healthcare Administration on 10/31/2024 revealed the following actions were taken after the serious event: Immediate follow up action was modification in the computer system order entry of phenytoin IV 15 mg/kg ordering string to link to 100 ml IVPB. IT pharmacist updated 15 mg/kg IV phenytoin ordering string special instructions to “max 50 mg/min, max dose 1500 mg” and as dose is now linked to 100 mg NS bag, computer system will calculate the rate of infusion based on 50mg/min. A review of Patient #4’s medical record revealed on 10/02/2024 at 4:34 PM Staff H, APRN (Advanced Practice Registered Nurse) ordered Dilantin 750 mg (15 mg/kg) once to infuse over 5 minutes max rate 50 mg/minute. The order was discontinued by pharmacy, clarified, and rewritten with a verbal order. The new order was Dilantin 750 mg (Dilantin 250 mg/ ml vial) sodium chloride 100 ml (fluid bag) to infuse at 345 ml /hour. Then on 10/16/2024 at 3:43 PM Staff H ARNP ordered the Dilantin 950 mg (15 mg/kg) once to infuse at a rate of 50 mg/minutes (should infuse over 19-20). Review of the eMAR (electronic Medication Administration Record) Staff K, RN administered the Dilantin IV (intravenous) push (a process of introducing a medication substance directly into the bloodstream at a rapid pace) on 10/16/2024 at 4:00 PM. Shortly after, Staff L, APRN arrived at the bedside with the attending physician, the patient was unresponsive to noxious (painful) stimuli, apneic (temporarily stops breathing), severe bradycardia (slow heartbeat less than 40 minute) and unable to obtain a blood pressure. Patient #4 then became pulseless and asystole (a life-threatening condition that occurs when the heart’s electrical and mechanical activity stops, resulting in no heartbeat). Per Disposition of Body form, Patient #4 expired on 10/16/2024 at 4:09 PM. During an interview on 11/14/2024 at 9:28 AM, Staff N (Off site Pharmacists) stated she reviewed the Dilantin (phenytoin) order. She saw the dose of the medication and assumed it was to be given with a saline bag. Staff N did not clarify the order with Staff H, ARNP. No evidence was provided regarding education of pharmacy, nursing or medical staff. 2. Review of the Corrective Action Plan submitted to the Agency for Health Care Administration on 10/18/24 showed the following actions were implemented after Patient #3 suffered irreversible brain damage and death: 1. Education with a read and sign on chain of command, escalation, notification, and proper documentation will be provided to staff in daily huddles in day and night shifts for 7 days with the requirement of completion prior to staff returning to work from PTO or any Leave. 2. Refresher on neurological assessment expectations, abnormal neurological findings, including the possible causation of abnormal assessments, and treatment plans. Validation of education with read & sign. 3. Read & sign on appropriate use of iMobile messaging system, process for obtaining orders from providers, expectations, and refresher on acknowledging orders only that they intend to carry out. Review of the medical record for Patient #3 revealed an arrival by ambulance on 10/1/2024 at approximately 4:00 AM, with a chief complaint of left sided weakness. Upon arrival he was found to be unresponsive, and was intubated (a medical procedure that involves inserting a tube into a patient’s body, usually through the mouth or nose, to help them breathe or deliver medication). A CT (computed tomography-imaging) of the brain was completed and revealed he had a right middle cerebral artery (MCA) thrombosis, known as a large vessel occlusion (blood clot/stroke). Interventional radiology was consulted and an emergent thrombectomy was performed (a procedure where a retrieval device is passed through a large blood vessel and guided to the brain where the blood clot is located and removed). The post procedural orders included frequent neuro checks; after 2 hours, neuro checks were hourly. (neuro checks are assessments of neurological function that include things like reflexes, pupil response and size). At approximately 8:30 AM he was sent to the ICU (Intensive Care Unit), where Staff A, RN (Registered Nurse) was assigned to care for him. The nursing assessment reflected pupil size bilaterally (both eyes) were equal and reactive at 2 mm (millimeters). Hourly neuro checks continued with no changes until 1:00 PM. There were no further neuro checks documented until 4:00 PM, which were unchanged. The next documented neuro check was at 8:00 PM, after shift change. Staff G, RN completed his assessment and documented the left pupil was 2 mm and responsive and the right pupil was 6 mm and fixed and dilated. Staff G, RN continued hourly neuro checks and they were unchanged until 12:00 AM 10/2/2024, she noted the left pupil was 4mm and the right was 6 mm, both fixed and dilated. The pupillary assessments were documented hourly, and at 4:00 AM they were noted to both be 6 mm, fixed and dilated, and remained that way for hourly neuro checks into the oncoming shift at 7 AM. On 10/1/24 at 11:00 AM, a nursing note entered by Staff B, RN revealed a physician was notified of the pupil change and rescheduled the CT for an earlier time in the morning. He noted that a respiratory therapist was not available to take the patient to CT scan at the scheduled. There were no further notes indicating a physician was notified of the progressive changes documented in Staff G, RN’s assessments. There was no documentation a stroke alert (a protocol for identifying stroke symptoms) being called for any of the documented changes. This was confirmed by Staff T, Director of Clinical Informatics during the record review on 11/12/2024 at approximately 11:39 AM. Review of physician’s order in the medical record revealed there was not an order to discontinue neuro checks. On 10/1/2024 at 11:56 PM, the physician ordered a scheduled CT scan for 5:00 AM on 10/2/2024. The CT was cancelled at 11:57 PM, and another CT was ordered for 7 AM on 10/2/2024. That CT was cancelled, and another CT was ordered for 8:45 AM on 10/2/2024. On 10/2/2024 at 8:30 AM a stat CT was ordered. These findings were confirmed by Staff T, Director of Clinical Informatics during the record review on 11/13/2024 at approximately 11:58 AM. On 10/2/2024 at 6:52 AM the Resident Physician’s progress note revealed “a repeat CT and MRI (Magnetic Resonance Imaging- a non-invasive medical imaging technique that uses radio waves and a strong magnetic field to create detailed pictures of the inside of the body.) of the brain were completed with findings of large evolving right MCA infarction (tissue death). Effacement of sulci and gyri in right cerebral hemisphere, marked mass effect on right lateral ventricle which is effaced. Midline shift from left to right of 2.2 cm. Increase of size of left ventricle. Areas of hemorrhage present within the infarct.” (see interpretation below) He noted that the physical exam was significantly worse with no gag reflex, cough reflex, or corneal response (eye response). On 10/2/2024 at 7:26 AM the Physician’s progress note revealed “sometime overnight the patient’ s eyes became fixed and dilated. Upon exam this morning he was sent for a stat MRI, (with the findings above documented). Neurosurgery was consulted emergently and saw the patient and said there was nothing they could do. Further exam showed the patient did not have any brainstem reflexes. The situation was discussed with his wife, who wants him to remain on life support so family can gather.” On 10/2/2024 at 9:17 AM the Neurology progress note revealed “there were no documented neurological changes overnight. The bedside RN this morning received report of neurological changes overnight, and it does not appear critical care staff were notified. The patient has no reflexes and does not respond to painful stimuli. He is not on any sedation. He is experiencing decerebrate posturing (an involuntary abnormal body position that is a sign of severe brain damage) with noxious stimuli.” On 10/2/2024 at 12:41 the Neurosurgeon consult note revealed “Per ICU team, patient has had an enlarged nonreactive pupil since around midnight. On exam, does not show any residual brain reflexes. This is a devastating injury, and I do not recommend neurosurgery in the setting of dismal exam. Findings shared with wife at bedside.” Review of the expiration record dated 10/5/2024 revealed a primary diagnosis of massive catastrophic CVA (cerebrovascular accident/stroke) with hemorrhagic conversion (bleeding), and evidence of brain death. After final neurological exam he was transferred to Life Link. Review of the policy, Assessment and Reassessment, 4/24/2023, revealed the following: Scope: All hospital caregivers and medical staff. Nursing Units: Policy: Any change in the patient’s condition shall require an immediate reassessment with changes in the plan of care reflecting the change of condition. Review of the Stroke Alert policy, 6/3/2024, reflected the following: Scope: All Health care providers at HCA Florida Brandon Hospital who are providing care to and/or managing the patients that are identified as having symptoms of a suspect3ed or known acute stroke. Purpose: To provide guidelines for initiating a stroke alert. To establish care guidelines for patients presenting with stroke symptoms. To delineate the roles of the stroke team during and immediately after a stroke alert is called. A stroke alert is called when a patient is exhibiting signs of a stroke. The stroke team along with the nurse providing care for the patient follow an established algorithm in order to provide a diagnosis and treatment plan in an expedited manner. During an interview on 11/12/2024 at 2:12 PM, Staff A, RN stated she got a text message on the hospital phone from the Nurse Practitioner Stroke Coordinator telling her she needed to finish the neuro checks up to 1:00 PM. Staff A, RN then asked if she needed to continue the neuro checks after that and got a text message back saying ‘no’. “I was under the impression she was auditing my documentation and letting me know I needed to complete it because I don’ t always document in real time. Sometimes it’ s later. She messaged me to continue neuro checks for 3 hours and I asked do we need to continue after that, and she said no. He was not any different at hand off than when I received him. I still assessed him, I just stopped charting it.” During a telephone interview on 11/13/2024 at 8:59 AM, Staff B, RN (night shift) said “when we came on shift the right pupil was 6 mm, the left was 2 mm. We didn’t know it was a change. So, when the physician came in to do rounds, we let him know.” The doctor didn’t go in the room to assess the patient after he was told. He rescheduled the CT scan from 7 AM to 5 AM. “The assessment is discussed, but when I got report, I was trying to fix the OG (oral-gastric) tube because it was on suction and there was blood coming out of it. It was on regular suction, so I lowered it to low intermittent suction because that was the order. We did not do the shift report together because of that. The change in pupils had to have happened between 1PM and 7PM. The nurse said she was told somebody called her and told her she could stop the neuro checks. I was never aware that it was a change.” During an interview on 11/13/2024 at 9:30 AM, Staff Q, Stroke Coordinator stated the record did not go for Peer review. The peer review coordinator was made aware. During an interview on 11/13/2024 at 10:20 AM, Staff I, MD said he has no recollection the nurse notified him of a change with the patient. “I have a very good memory. I would have remembered if I was notified. He may have told a Resident.” During an interview on 11/13/24 at 10:35 AM, Staff S, RN ICU (intensive care unit) stated “We do bedside report. Look at the patient. Do a neuro assessment together at the bedside. I would notify the Resident and the intensivist to ask for a stroke alert and take the patient straight to CT.” During an interview on 11/13/2024 at 10:38 AM, Staff R, Director of Critical Care stated she did participate in the investigation. Staff I, MD was present during rounds and was notified of the change by the nurse. During a telephone interview on 11/13/2024 at 10:54 AM, Staff H, APRN (Advanced Practice Registered Nurse) stated “We send out drill downs of required assessments per the comprehensive stroke program. I told her to continue the neuro checks. I recall telling her we needed the required neuro checks for the program. I don’t remember telling her to discontinue the neuro checks.” During a telephone interview on 11/13/24 at 2:04 PM, Staff E, Resident physician stated “I don’t think I was notified about it. Someone else may have been notified. The patient will have a follow up CT in the morning after a procedure like that. I was not notified of any neurologic change for the patient. I don’t think the communication was there.” During a telephone interview on 11/13/2024 at 5:30 PM, Staff D, Resident physician stated “We have three residents on at night. We stay awake all night. Nursing reaches out to us. I don’t recall any notification. I would have gotten a stat CT. The only reason I wouldn’t order it stat is if it wasn’t a change in the patient’s condition. I may have rounded on him. I don’t know why I would have cancelled the CT. This was during overnight rounds. It should have been a stat CT scan. There would have been a repeat post thrombectomy CT in the morning. Nurses are the bigger bridge and see the neurologic changes. Unless we were alerted, we wouldn’t go in and assess the patient. The nurses are the ones doing the neuro checks. When critical care does nightly rounds from 9 to 12, often the orders are put in by one person. The attending may have told me to cancel the CT. That’s the only thing I can think of.” During an interview on 11/14/24 at 12:32 PM, the CEO (Chief Executive Officer) stated they would “not provide nor discuss their investigation, analysis, and corrective action plan. It’s legally protected PSO (Patient Safety Organization) information.” During a group interview on 11/14/24 at 1:15 PM, the Director of Patient Safety, the Director of Quality, the Assistant Chief Nursing Officer (ACNO), the Director of Respiratory/Cardiopulmonary Services, the Patient Safety Coordinator, and by video conferencing Staff G, RN, Staff A, RN, the VP (Vice President) of Operations, and Staff V, Director of Critical Care were all present. Staff G, RN said she was on orientation at that time. “We got report from the morning nurse. She confirmed from the stroke coordinator that neuro checks were stopped at 1:00 PM. We assessed the patient and noticed the pupils were unequal in size. During the rounds with the doctors, we informed them about the findings. The attending, Staff I, the Residents, the charge nurse, and the nurse assigned to the patient all participate in rounds. There was a repeat CT scan scheduled for 5 AM; it was originally scheduled for 10 AM. I told the Respiratory Therapist (RT) through phone messaging that we had a CT order. She said she was not available, and so we asked for a later time. She then said she still couldn’t do it and wasn’t available to do it until after shift change. We were unable to do a CT scan on our shift. If it was stat we would have to escalate to the charge and see if there is another RT available to help us. I don’t think the physician was aware that it couldn’t be done at that time.” Staff A, RN said “I received a message from the Nurse Practitioner asking about the neuro checks. I then messaged her asking if she wanted us to continue the neuro checks; she said no. I do not recall if she put the order in.” The providers have to put their own orders in, not the nurse. The Director of Respiratory/Cardiopulmonary services said scheduling is based on the census. There are usually six to eight respiratory therapists during the day. One to two less on the night shift. “We go by a point scale. We go by what procedures the patients are on. I would never say we are not going to a CT. For a routine scan, they would try to work with the nurse on coordinating the time. A stat they would be available.” The Assistant Chief Nursing Officer (ACNO) said she was there for all of it. Staff A, RN was out of state. Staff B, RN was out on sick leave. “We did pull the I-mobile messages. What was communicated to the Respiratory Therapist (RT) was that they wanted to schedule a 5 AM CT. The RT replied she had a scheduled extubation at that time.” Staff G, RN who was orienting said ‘okay’. It was not a stat [immediate] CT. RT does their shift change at 6 AM. The day nurse was messaging with the neuro APRN throughout the day. She told the nurse she had to do the next three neuro checks. The nurse (Staff A, RN) asked if she wanted to continue the neuro checks. The APRN said no. Nurses cannot take orders over I-mobile. So that was one of the causes. The neuro checks were not discontinued, so she (Staff A) should have continued them. The next one was the bedside shift report. “We reviewed the footage, and they did go in the room together. They did do the assessment, but they did not do a pupillary check. So, we educated on this. At 9:00 PM when they did their first neuro assessment, that’s when they identified there was a change in the neuros [neurological status]. The nurses knew the ICC (intensivist group) would be rounding any minute. When they didn’t come on rounds, Staff B, RN realized he should have notified them and asked them to come to the bedside. We did education on that. We educated respiratory. Rounds occurred around 11:45 PM. It was Staff I, MD intensivist, two Residents, the charge RN, the primary RN and the preceptor. We reviewed that video as well. Staff B, RN was pointing to his eyes when he was talking to the physician. The charge went in the room. He did an assessment of the patient, to see if he agreed with the primary nurse. At that time, they decided to move the CT schedule up to 5 AM. We identified that a change in pupils should have initiated a stat CT. The CT was scheduled at 5 AM, changed to 7 AM, and changed to 9 AM. The last order was stat. Staff G, RN did not acknowledge that order. She was educated on acknowledging orders. There was a delay in the results coming in, and that was addressed with the radiology department. The record was referred for a peer review. We did education with staff about what it means when the pupils have changed, change of condition, escalation, identification of neuro changes, bedside shift report, appropriate orders. That was the immediate stuff, and frequent neuro check audits which were after the fact, and we have changed them to real time audits from the charge nurses. We have been auding ten records a week. We have addressed the order set itself. If we have a protocol and an order set that are conflicting, then we need to narrow that gap, and that is currently under review. It takes a little more time. We are reminding the nurses they need to review their orders and if they need their orders changed to reach out. It was a very long, extensive investigation. We pulled videos, I-mobile messages and did a very thorough review. The nurse needs to escalate to the charge and lead RT when an RT says they are not available.” The corrective actions reported by the ACNO during the investigation were the educational materials for nursing with sign in sheets, and audits. Review of the sign-in-sheets documenting receipt of the educational materials reflected Staff A, RN and Saff B, RN, who were involved in the adverse incident, had not received them. During an interview on 11/12/2024 at 2:12 PM, Staff A, RN confirmed she had not received the education. She stated that she was away on vacation. She received a message from the director but was already out of the country. The director said, ‘we will talk when you come back’. Staff A reported that she came back to work last Tuesday. This is her second day back to work because after she returned to work last week, then she got sick.”

“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 review of corrective action plans, medical records, interviews, and policy review, the hospital failed to ensure the QAPI (Quality Assurance Performance Improvement) program was able to identify and reduce medical errors by completing a thorough investigation and analysis 1) of adverse medication events resulting in a serious adverse medication event for 1 (Patient #4) of 3 patients sampled, and 2) that a corrective action plan was implemented fully, and addressed all root causes, after a serious event resulting in death was discovered for 1 (Patient #3) of 3 sampled patients. Findings included: 1. Review of facility Corrective Action Plan submitted to the Agency for Healthcare Administration on 10/31/2024 revealed the following actions were taken after the serious event: Immediate follow up action was modification in computer system order entry of phenytoin (Dilantin) IV 15 mg/kg ordering string to link to 100 ml IVPB. IT pharmacist updated 15 mg/kg IV phenytoin ordering string special instructions to “max 50 mg/min, max dose 1500 mg” and as dose is now linked to 100 mg NS bag, and the computer system will calculate rate of infusion based on 50mg/min. Review of the medical record for Patient #4 revealed that on 10/02/2024 at 4:34 PM Staff H, APRN (Advanced Practice Registered Nurse) ordered Dilantin 750 mg (15 mg/kg) once, to infuse over 5 minutes. Maximum rate 50 mg/minute.The order was discontinued by pharmacy. The order was clarified and rewritten with a verbal order. The new order was Dilantin 750 mg (Dilantin 250 mg/ ml vial) sodium chloride 100 ml (1 bag fluid) to infuse at 345 ml /hour. Then on 10/16/2024 at 3:43 PM Staff H, APRN ordered Dilantin 950 mg (15 mg/kg) once, to infuse at a rate of 50 mg/minute (19-20 minutes to infuse). Staff K, RN administered the Dilantin IV push (a process of introducing a medication substance directly into the bloodstream at a rapid pace) on 10/16/2024 at 4:00 PM. Patient #4 expired at 4:09 PM. During an interview on 11/13/2024 at 10:06 AM, Staff O, RN stated she is pretty sure that in the past they have had education on the medication Dilantin. The Director of Critical Care interjected and stated that they received education in huddle this morning. Staff O, RN then said “that is right. We were re-educated this morning in huddle.” During an interview on 11/13/2024 at 10:27 AM, Staff P, RN stated she did not receive any education on Dilantin. Staff P, RN confirmed she was in huddle today and she does not recall education for Dilantin. During an interview on 11/14/2024 at 9:28 AM, Staff N (Off site Pharmacists) stated she reviewed the Dilantin order. She saw the dose of the medication and assumed it was to be given with a saline bag. Staff N did not clarify the order with Staff H, ARNP. No evidence was provided the staff received education on the preparation and administration of IV Dilantin. No evidence was provided the providers received education on understanding how to report an issue with the order set. No evidence was provided pharmacy received educaiton regarding order clarification. No evidence was provided nursing staff received training and education on documentation of when there is a change in condition. 2. Review of the Corrective Action Plan submitted to the Agency for Health Care Administration on 10/18/24 showed the following actions were implemented after Patient #3 suffered irreversible brain damage and death resulting from inappropriate use of messaging system for communication and clarification of physician orders, failure to communicate assessment findings during shift change report, and failure to appropriately identify a change in condition and notify the physician in a timely manner: 1. Education with a read and sign on chain of command, escalation, notification, and proper documentation will be provided to staff in daily huddles in day and night shifts for 7 days with the requirement of completion prior to staff returning to work from PTO or any Leave. 2. Refresher on neurological assessment expectations, abnormal neurological findings, including the possible causation of abnormal assessments, and treatment plans. Validation of education with read & sign. 3. Read & sign on appropriate use of iMobile messaging system, process for obtaining orders from providers, expectations, and refresher on acknowledging orders only that they intend to carry out. Review of the medical record for Patient #3 revealed an arrival by ambulance on 10/1/2024 at approximately 4:00 AM, with a chief complaint of left sided weakness. Upon arrival he was found to be unresponsive, not protecting his airway and was intubated (a medical procedure that involves inserting a tube into a patient’s body, usually through the mouth or nose, to help them breathe or deliver medication). A CT (computed tomography-imaging) of the brain was completed and revealed he had a right middle cerebral artery (MCA) thrombosis, known as a large vessel occlusion (blood clot/stroke). Interventional radiology was consulted and an emergent thrombectomy was performed (a procedure where a retrieval device is passed through a large blood vessel and guided to the brain where the blood clot is located and removed). The post procedural orders included frequent neuro checks; after 2 hours, neuro checks were hourly. (neuro checks are assessments of neurological function that include things like reflexes, pupil response and size). At approximately 8:30 AM he was sent to the ICU (Intensive Care Unit), where Staff A, RN (Registered Nurse) was assigned to care for him. The nursing assessment reflected pupil size bilaterally (both eyes) were equal and reactive at 2 mm (millimeters). Hourly neuro checks continued with no changes until 1:00 PM. There were no further neuro checks documented until 4:00 PM, which were unchanged. The next documented neuro check was at 8:00 PM, after shift change. Staff G, RN completed his assessment and documented the left pupil was 2 mm and responsive and the right pupil was 6 mm and fixed and dilated. Staff G, RN continued hourly neuro checks and they were unchanged until 12:00 AM 10/2/2024, she noted the left pupil was 4mm and the right was 6 mm, both fixed and dilated. The pupillary assessments were documented hourly, and at 4:00 AM they were noted to both be 6 mm, fixed and dilated, and remained that way for hourly neuro checks into the oncoming shift at 7 AM. On 10/1/24 at 11:00 AM, a nursing note entered by Staff B, RN revealed a physician was notified of the pupil change and rescheduled the CT for an earlier time in the morning. He noted that a respiratory therapist was not available to take the patient to CT scan at the scheduled time. There were no further notes indicating a physician was notified of the progressive changes documented in Staff G, RN’s assessments. There was no documentation a stroke alert (a protocol for identifying stroke symptoms) being called for any of the documented changes. This was confirmed by Staff T, Director of Clinical Informatics during the record review on 11/12/2024 at approximately 11:39 AM. Review of physician’s order in the medical record reflected there wasn’t an order to discontinue neuro checks. Further review of the physician’s order reflected CT scan ordered on 10/1/24 at 11:56 PM for 5:00 AM on 10/2/24. The CT was cancelled at 11:57 PM, and another CT was ordered for 7 AM on 10/2/24. The CT was cancelled, and another CT was ordered for 8:45 AM on 10/2/24. On 10/2/24 at 8:30 AM a stat CT was ordered. These findings were confirmed by Staff T, Director of Clinical Informatics during the record review on 11/13/24 at approximately 11:58 AM. Review of a Resident physician’s progress note for an assessment completed at 6:52 AM on 10/2/24 reflected a repeat CT and MRI (magnetic resonance imaging-more detailed imaging) of the brain were completed with findings of large evolving right MCA infarction (tissue death). Effacement of sulci and gyri in right cerebral hemisphere, marked mass effect on right lateral ventricle which is effaced. Midline shift from left to right of 2.2 cm. Increase of size of left ventricle. Areas of hemorrhage present within the infarct. (see interpretation below) He noted that the physical exam was significantly worse with no gag reflex, cough reflex, or corneal response (eye response). On 10/2/2024 at 7:26 AM the Physician’s progress note revealed “sometime overnight the patient’s eyes became fixed and dilated. Upon exam this morning he was sent for a stat MRI, (with the findings above documented). Neurosurgery was consulted emergently and saw the patient and said there was nothing they could do. Further exam showed the patient did not have any brainstem reflexes. The situation was discussed with his wife, who wants him to remain on life support so family can gather.” On 10/2/2024 at 9:17 AM the Neurology progress note revealed “there were no documented neurological changes overnight. The bedside RN this morning received report of neurological changes overnight, and it does not appear critical care staff were notified. The patient has no reflexes and does not respond to painful stimuli. He is not on any sedation. He is experiencing decerebrate posturing (an involuntary abnormal body position that is a sign of severe brain damage) with noxious stimuli.” On 10/2/2024 at 12:41 the Neurosurgeon consult note revealed “Per ICU team, patient has had an enlarged nonreactive pupil since around midnight. On exam, does not show any residual brain reflexes. This is a devastating injury, and I do not recommend neurosurgery in the setting of dismal exam. Findings shared with wife at bedside.” Review of the expiration record dated 10/5/2024 revealed a primary diagnosis of massive catastrophic CVA (cerebrovascular accident/stroke) with hemorrhagic conversion (bleeding), and evidence of brain death. After final neurological exam he was transferred to [organ donation]. During an interview on 11/12/2024 at 2:12 PM, Staff A, RN stated she got a text message on the hospital phone from the nurse practitioner stroke coordinator telling her she needed to finish the neuro checks up to 1:00 PM. Staff A, RN then asked if she needed to continue the neuro checks after that and got a text message back saying ‘no’. “I was under the impression she was auditing my documentation and letting me know I needed to complete it because I don’ t always document in real time. Sometimes it’ s later. She messaged me to continue neuro checks for 3 hours and I asked do we need to continue after that, and she said no. He was not any different at hand off than when I received him. I still assessed him, I just stopped charting it.” During a telephone interview on 11/13/2024 at 8:59 AM, Staff B,RN (night shift) said “when we came on shift the right pupil was 6 mm, the left was 2 mm. We didn’t know it was a change. So, when the physician came in to do rounds, we let him know.” The doctor didn’t go in the room to assess the patient after he was told. He rescheduled the CT scan from 7 AM to 5 AM. “The assessment is discussed, but when I got report, I was trying to fix the OG (oral-gastric) tube because it was on suction and there was blood coming out of it. It was on regular suction, so I lowered it to low intermittent suction because that was the order. We did not do the shift report together because of that. The change in pupils had to have happened between 1PM and 7PM. The nurse said she was told somebody called her and told her she could stop the neuro checks. I was never aware that it was a change.” During an interview on 11/13/2024 at 9:30 AM, Staff U, Stroke Coordinator stated the record did not go for Peer review. The peer review coordinator was made aware. During an interview on 11/13/2024 at 10:20 AM, Staff I, MD said he has no recollection the nurse notified him of a change with the patient. “I have a very good memory. I would have remembered if I was notified. He may have told a Resident.” During an interview on 11/13/24 at 10:35 AM, Staff S, RN ICU stated “We do bedside report. Look at the patient. Do a neuro assessment together at the bedside. I would notify the Resident and the intensivist to ask for a stroke alert and take the patient straight to CT.” During an interview on 11/13/2024 at 10:38 AM, Staff V, Director of Critical Care said Staff R stated she did participate in the investigation. Staff I, MD was present during rounds and was notified by the nurse. During a telephone interview on 11/13/2024 at 10:54 AM, Staff H, APRN stated “We send out drill downs of required assessments per the comprehensive stroke program. I told her to continue the neuro checks. I recall telling her we needed the required neuro checks for the program. I don’t remember telling her to discontinue the neuro checks.” During a telephone interview on 11/13/24 at 2:04 PM, Staff E, Resident physician stated “I don’t think I was notified about it. Someone else may have been notified. The patient will have a follow up CT in the morning after a procedure like that. I was not notified of any neurologic change for the patient. I don’t think the communication was there.” During a telephone interview on 11/13/24 at 5:30 PM, Staff D, Resident physician stated “We have three residents on at night. We stay awake all night. Nursing reaches out to us. I don’t recall any notification. I would have gotten a stat CT. The only reason I wouldn’t order it stat is if it wasn’t a change in the patient’s condition. I may have rounded on him. I don’t know why I would have cancelled the CT. This was during overnight rounds. It should have been a stat CT scan. There would have been a repeat post thrombectomy CT in the morning. Nurses are the bigger bridge and see the neurologic changes. Unless we were alerted, we wouldn’t go in and assess the patient. The nurses are the ones doing the neuro checks. When critical care does nightly rounds from 9 to 12, often the orders are put in by one person. The attending may have told me to cancel the CT. That’s the only thing I can think of.” During an interview on 11/14/24 at 12:32 PM, the CEO (Chief Executive Officer) stated they would “not provide nor discuss their investigation, analysis, and corrective action plan. It’s legally protected PSO (patient safety organization) information.” During a group interview on 11/14/24 at 1:15 PM, Director of Patient Safety, the Director of Quality, the Assistant Chief Nursing Officer (ACNO), the Director of Respiratory/Cardiopulmonary Services, the Patient Safety Coordinator, and by video conferencing Staff G, RN, Staff A, RN, the VP (Vice President) of Operations, and Staff V, Director of Critical Care were present. Staff G, RN said she was on orientation during that time. “We got report from the morning nurse. She confirmed from the stroke coordinator that neuro checks were stopped at 1:00 PM. We assessed the patient and noticed the pupils were unequal in size. During the rounds with the doctors, we informed them about the findings. The attending, Staff I, the Residents, the charge nurse, and the nurse assigned to the patient participated in rounds. There was a repeat CT scan for 5 AM. It was originally scheduled for 10 AM. I told the Respiratory Therapist (RT) through messaging that we had a CT order. She said she was not available, and so we asked for a later time, and she said she still couldn’t do it, and wasn’t available to do it until after her shift. So, we were unable to do a CT scan on our shift. If it was STAT we would have to escalated to the charge RN and see if there is another RT available to help us. I don’t think the physician was aware that it couldn’t be done at that time.” Staff A, RN said “I received a message from the Nurse Practitioner asking about the neuro checks and I messaged her if she wanted us to continue the neuro checks. She said no. I do not recall if she put the order in.” The providers have to put their own orders in. Not the nurse. The Director of Cardiopulmonary/Respiratory Services said scheduling is based on the census. There are usually six to eight respiratory therapists during the day. One to two less on the night shift. “We go by a point scale. We go by what procedures the patients are on. I would never say we are not going to a CT. A routine scan, they would try to work with the nurse on coordinating the time. A stat they would be available.” The Assistant Chief Nursing Officer (ACNO) said she was there for all of it. Staff A, RN was out of state. Staff B, RN was out on sick leave. “We did pull the I-mobile messages. What was communicated to the Respiratory Therapist (RT) was that they wanted to schedule a 5 AM CT. The RT replied she had a scheduled extubation at that time.” Staff G, RN who was on orientation said ‘okay.’ It was not a stat (immediate) CT. RT do their shift change at 6 AM. The day nurse was messaging with the neuro APRN throughout the day. She told the nurse she had to do the next three neuro checks. The nurse (Staff A, RN) asked if she wanted to continue the neuro checks. The APRN said no. Nurses cannot take orders over I-mobile. So that was one of the causes. The neuro checks were not discontinued, so she (Staff A) should have continued them. The next one was the bedside shift report. “We reviewed the footage, and they did go in the room together. They did do the assessment, but they did not do a pupillary check. So, we educated on this. At 9:00 when they did their first neuro assessment, that ’ s when they identified there was a change in the neuros. The nurses knew the ICC (intensivist group) would be rounding any minute. When they didn’t come on rounds, Staff B, RN realized he should have notified them and asked them to come to the bedside. We did education on that. We educated respiratory. Rounds occurred around 11:45. It was Staff I, MD intensivist, two Residents, the charge, the primary (nurse) and the preceptor. We reviewed that video as well. Staff B, RN was pointing to his eyes when he was talking to the physician. The charge went in the room. He did an assessment of the patient, to see if he agreed with the primary nurse. At that time, they decided to move the CT schedule up to 5 AM. We identified that a change in pupils should have initiated a stat CT. The CT was scheduled at 5, changed to 7, and changed to 9. The last order was stat. Staff G, RN did not acknowledge that order. She was educated on acknowledging orders. There was a delay in the results coming in, and that was addressed with the radiology department. The record was referred for a peer review. We did education with staff about what it means when the pupils have changed, change of condition, escalation, identification of neuro changes, bedside shift report, appropriate orders. That was the immediate stuff, and frequent neuro check audits which were after the fact, and we have changed them to real time audits from the charge nurses. We have been auding ten records a week. We have addressed the order set itself. If we have a protocol and an order set that are conflicting, then we need to narrow that gap, and that is currently under review. It takes a little more time. We are reminding the nurses they need to review their orders and if they need their orders changed to reach out. It was a very long, extensive investigation. We pulled videos and I-mobile messages and did a very thorough review. The nurse needs to escalate to the charge and lead RT when an RT says they are not available.” The corrective actions reported from the ACNO that were provided during the investigation were the educational materials with sign in sheets, and audits. Review of the educational sign in sheets revealed Staff A, RN and Saff B, RN, involved in adverse event, had not received the education as of 11/12/2024. During an interview on 11/12/2024 at 2:12 PM, Staff A, RN confirmed she had not received the education. She stated that she was away on vacation. She received a message from the director but was already out of the country. The director said, “we will talk when you come back”. Staff A reported that she came back to work last Tuesday. This is her second day back to work because after she returned to work last week, she got sick. Review of the policy, Assessment and Reassessment, 4/24/23, revealed the following: Scope: All hospital caregivers and medical staff. Nursing Units: Policy: Any change in the patient’s condition shall require an immediate reassessment with changes in the plan of care reflecting the change of condition. Review of the Stroke Alert policy, 6/3/24, reflected the following: Scope: All Health care providers at HCA Florida Brandon Hospital who are providing care to and/or managing the patients that are identified as having symptoms of a suspected or known acute stroke. Purpose: To provide guidelines for initiating a stroke alert. To establish care guidelines for patients presenting with stroke symptoms. To delineate the roles of the stroke team during and immediately after a stroke alert is called. A stroke alert is called when a patient is exhibiting signs of a stroke. The stroke team along with the nurse providing care for the patient follow an established algorithm in order to provide a diagnosis and treatment plan in an expedited manner. As of 11/14/24 at approximately 4:30 PM, no analysis or corrective action was provided apart from nursing education. No evidence was provided Staff A and Staff B received the education prior to the survey. No evidence was provided regarding the availability of RTs for CT scan, orders for a stat CT during a change in condition and a bedside assessmet by the physician made aware of an abnormal finding,”

“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 review of medical records, policy reviews, and interviews conducted, the hospital failed to ensure appropriate supervision of nursing services provided in the ICU (Intensive Care Unit) for a RN (Registered Nurse) on orientation, and a disaster relief RN. Failure of appropriate supervision resulted in the death of 2 (Patient #3 and Patient #4) of 3 sampled patients. Findings included: 1. Review of the medical record for Patient #3 revealed an arrival by ambulance on 10/1/24 at approximately 4:00 AM, with a chief complaint of left sided weakness. Upon arrival he was found to be unresponsive and was intubated. A CT (computed tomography-imaging) of the brain was completed and revealed he had a right middle cerebral artery (MCA) thrombosis, known as a large vessel occlusion (blood clot/stroke). Interventional radiology was consulted and an emergent thrombectomy was performed (a procedure where a retrieval device is passed through a large blood vessel and guided to the brain where the blood clot is located and removed). The post procedural orders included frequent neuro checks; after 2 hours, neuro checks were hourly. (neuro checks are assessments of neurological function that include things like reflexes, pupil response and size). At approximately 8:30 AM he was sent to the ICU (Intensive Care Unit), where Staff A, RN (registered nurse) was assigned to care for him. At that time his nursing assessment reflected pupil size bilaterally (both eyes) were equal and reactive at 2 mm (millimeters). Hourly neuro checks continued with no changes until 1:00 PM. There were no further neuro checks documented until 4:00 PM, which were unchanged. The next documented neuro check was at 8:00 PM, after shift change. Staff G, RN completed his assessment and documented the left pupil was 2 mm and responsive. She documented the right pupil was 6 mm and fixed and dilated. Staff G, RN continued hourly neuro checks and they were unchanged until 12:00 AM 10/2/24, where she noted the left pupil was 4mm and the right was 6 mm, both fixed and dilated. The pupillary assessments were documented hourly, and at 4:00 AM they were noted to both be 6 mm, fixed and dilated, and remained that way for hourly neuro checks into the oncoming shift at 7 AM. On 10/1/24 at 11:00 PM, a nursing note entered by Staff B, RN reflected a physician was notified of the pupil change and rescheduled the CT for an earlier time in the morning. He noted that a respiratory therapist was not available to take the patient to CT scan at the scheduled time. There were no further notes indicating a physician was notified of the progressive changes documented in Staff G’s assessments. There was no documentation a stroke alert for the pupil changes. This was confirmed by Staff T, Director of Clinical Informatics during the record review on 11/12/24 at approximately 11:39 AM. Review of physician’s orders in the medical record reflected there was not an order to discontinue neuro checks. Further review revealed the CT scan ordered on 10/1/24 at 11:56 PM was scheduled on 10/2/24 at 5:00 AM. That CT was cancelled at 11:57 PM, and another CT was ordered for 7 AM on 10/2/24. That CT was cancelled, and another CT was ordered for 8:45 AM on 10/2/24. On 10/2/24 at 8:30 AM a stat CT was ordered. These findings were confirmed by Staff T, Director of Clinical Informatics during the record review on 11/13/24 at approximately 11:58 AM. On 10/2/2024 at 6:52 AM the Resident Physician’s progress note revealed “a repeat CT and MRI (Magnetic Resonance Imaging- a non-invasive medical imaging technique that uses radio waves and a strong magnetic field to create detailed pictures of the inside of the body.) of the brain were completed with findings of large evolving right MCA infarction (tissue death). Effacement of sulci and gyri in right cerebral hemisphere, marked mass effect on right lateral ventricle which is effaced. Midline shift from left to right of 2.2 cm. Increase of size of left ventricle. Areas of hemorrhage present within the infarct.” (see interpretation below) He noted that the physical exam was significantly worse with no gag reflex, cough reflex, or corneal response (eye response). On 10/2/2024 at 7:26 AM the Physician’s progress note revealed “sometime overnight the patient’s eyes became fixed and dilated. Upon exam this morning he was sent for a stat MRI, (with the findings above documented). Neurosurgery was consulted emergently and saw the patient and said there was nothing they could do. Further exam showed the patient did not have any brainstem reflexes. The situation was discussed with his wife, who wants him to remain on life support so family can gather.” On 10/2/2024 at 9:17 AM the Neurology progress note revealed “there were no documented neurological changes overnight. The bedside RN this morning received report of neurological changes overnight, and it does not appear critical care staff were notified. The patient has no reflexes and does not respond to painful stimuli. He is not on any sedation. He is experiencing decerebrate posturing (an involuntary abnormal body position that is a sign of severe brain damage) with noxious stimuli.” On 10/2/2024 at 12:41 the Neurosurgeon consult note revealed “Per ICU team, patient has had an enlarged nonreactive pupil since around midnight. On exam, does not show any residual brain reflexes. This is a devastating injury, and I do not recommend neurosurgery in the setting of dismal exam. Findings shared with wife at bedside.” Review of the expiration record dated 10/5/2024 revealed a primary diagnosis of massive catastrophic CVA (cerebrovascular accident/stroke) with hemorrhagic conversion (bleeding), and evidence of brain death. After final neurological exam he was transferred to [organ donation]. Review of the policy, Assessment and Reassessment, 4/24/23, revealed the following: Scope: All hospital caregivers and medical staff. Nursing Units: Policy: Any change in the patient’s condition shall require an immediate reassessment with changes in the plan of care reflecting the change of condition. Review of the Stroke Alert policy, 6/3/24, reflected the following: Scope: All Health care providers at HCA Florida Brandon Hospital who are providing care to and/or managing the patients that are identified as having symptoms of a suspect3ed or known acute stroke. Purpose: To provide guidelines for initiating a stroke alert. To establish care guidelines for patients presenting with stroke symptoms. To delineate the roles of the stroke team during and immediately after a stroke alert is called. A stroke alert is called when a patient is exhibiting signs of a stroke. The stroke team along with the nurse providing care for the patient follow an established algorithm in order to provide a diagnosis and treatment plan in an expedited manner. During an interview on 11/12/2024 at 2:12 PM, Staff A, RN stated she got a text message on the hospital phone from the Nurse Practitioner Stroke Coordinator telling her she needed to finish the neuro checks up to 1:00 PM. Staff A, RN then asked if she needed to continue the neuro checks after that and got a text message back saying ‘no’. “I was under the impression she was auditing my documentation and letting me know I needed to complete it because I don’t always document in real time. Sometimes it’s later. She messaged me to continue neuro checks for 3 hours and I asked do we need to continue after that, and she said no. He was not any different at hand off than when I received him. I still assessed him, I just stopped charting it.” During a telephone interview on 11/13/2024 at 8:59 AM, Staff B, RN (night shift) said “when we came on shift the right pupil was 6 mm, the left was 2 mm. We didn’t know it was a change. So, when the physician came in to do rounds, we let him know.” The doctor didn’t go in the room to assess the patient after he was told. He rescheduled the CT scan from 7 AM to 5 AM. “The assessment is discussed, but when I got report, I was trying to fix the OG (oral-gastric) tube because it was on suction and there was blood coming out of it. It was on regular suction, so I lowered it to low intermittent suction because that was the order. We did not do the shift report together because of that. The change in pupils had to have happened between 1PM and 7PM. The nurse said she was told somebody called her and told her she could stop the neuro checks. I was never aware that it was a change.” During an interview on 11/13/2024 at 10:20 AM, Staff I, MD (Intensivist) said he has no recollection the nurse notified him of a change with the patient. “I have a very good memory. I would have remembered if I was notified. He may have told a Resident.” During an interview on 11/13/2024 at 10:35 AM, Staff S, RN ICU (Intensive Care Unit) said “We do bedside report. Look at the patient. Do a neuro assessment together at the bedside. I would notify the Resident and the intensivist to ask for a stroke alert and take the patient straight to CT.” During an interview on 11/13/2024 at 10:38 AM, Staff R, Director of Critical Care said she did participate in the investigation. Staff I, MD was present during rounds and was notified by the nurse. During a telephone interview on 11/13/2024 at 10:54 AM, Staff H, APRN (Advanced Practice Registered Nurse) said “We send out drill downs of required assessments per the comprehensive stroke program. I told her to continue the neuro checks. I recall telling her we needed the required neuro checks for the program. I don ’ t remember telling her to discontinue the neuro checks.” During a telephone interview on 11/13/2024 at 2:04 PM, Staff E, Resident Physician said “I don’t think I was notified about it. Someone else may have been notified. The patient will have a follow up CT in the morning after a procedure like that. I was not notified of any neurologic change for the patient. I don ’ t think the communication was there.” During a telephone interview on 11/13/2024 at 5:30 PM, Staff D, Resident Physician said “We have three residents on at night. We stay awake all night. Nursing reaches out to us. I don’t recall any notification. I would have gotten a stat CT. The only reason I wouldn’t order it stat is if it wasn’t a change in the patient’s condition. I may have rounded on him. I don’t know why I would have cancelled the CT. This was during overnight rounds. It should have been a stat CT scan. There would have been a repeat post thrombectomy CT in the morning. Nurses are the bigger bridge and see the neurologic changes. Unless we were alerted, we wouldn’t go in and assess the patient. The nurses are the ones doing the neuro checks. When critical care does nightly rounds from 9 to 12, often the orders are put in by one person. The attending may have told me to cancel the CT. That’s the only thing I can think of.” During a group interview on 11/14/2024 at 1:15 PM, the Director of Patient Safety, Director of Quality, Assistant Chief Nursing Officer (ACNO), Director of Respiratory/Cardiopulmonary, Patient Safety Coordinator, and by video conferencing Staff G, RN, Staff A, RN, VP of Operations, and Staff V, Director of Critical Care were all present. Staff G, RN said she was on orientation at that time. “We got report from the morning nurse. She confirmed from the Stroke Coordinator that neuro checks were stopped at 1:00 PM. We assessed the patient and noticed the pupils were unequal in size. During the rounds with the doctors, we informed them about the findings. The Attending, Staff I, Residents, Charge Nurse, and the RN assigned to the patient participated in rounds. There was a repeat CT scan for 5 AM. It was originally scheduled for 10 AM. I told the respiratory therapist (RT) through messaging that we had a CT order. She said she was not available, and so we asked for a later time, and she said she still couldn’t do it and wasn’t available to do it until after her shift. We were unable to do a CT scan on our shift. If it was stat we would have to escalate to the charge and see if there is another RT available to help us. I don’t think the physician was aware that it couldn’t be done at that time.” Staff A, RN said “I received a message from the Nurse Practitioner asking about the neuro checks and I messaged her asking if she wanted us to continue the neuro checks. She said no. I do not recall if she put the order in.” The providers have to put their own orders in. Not the nurse. Director of Cardiopulmonary/Respiratory services said scheduling is based on the census. There are usually 6 to 8 respiratory therapists during the day. 1 to 2 less on the night shift. “We go by a point scale. We go by what procedures the patients are on. I would never say we are not going to a CT. A routine scan, they would try to work with the nurse on coordinating the time. A stat they would be available.” 2. Review of Patient #4’s medical record revealed on 10/02/2024 at 4:34 PM Staff H, APRN (Advanced Practice Registered Nurse) ordered Dilantin (phenytoin) 750 mg (15 mg/kg) once to infuse over 5 minutes max rate 50 mg/minute (seizure medication). The order was discontinued by pharmacy, clarified, and rewritten with a verbal order. The new order was Dilantin 750 mg (Dilantin 250 mg/ ml vial) sodium chloride 100 ml (fluid bag) to infuse at 345 ml /hour. Then on 10/16/2024 at 3:43 PM Staff H APRN ordered the Dilantin 950 mg (15 mg/kg) once to infuse at a rate of 50 mg/minutes (should infuse over 19-20). Review of the eMAR (electronic Medication Administration Record) Staff K, RN administered the Dilantin IV (intravenous) push (a process of introducing a medication substance directly into the bloodstream at a rapid pace) on 10/16/2024 at 4:00 PM. Shortly after, Staff L, APRN arrived at the bedside with the attending, the patient was unresponsive to noxious (painful) stimuli, apneic (temporarily stops breathing), severe bradycardia (slow heartbeat less than 40 minute) and unable to obtain a blood pressure. Patient #4 then became pulseless and asystolic (a life-threatening condition that occurs when the heart’s electrical and mechanical activity stops, resulting in no heartbeat). Per Disposition of Body form, Patient #4 expired on 10/16/2024 at 4:09 PM. On 10/16/2024 at 5:59 PM the Critical care was documented showing Staff L, APRN arrived to the bedside with the attending and the patient was unresponsive with noxious (painful) stimuli, apneic (temporarily stops breathing) and severe bradycardic (slow heartbeat less than 40 minute) and unable to obtain a blood pressure. Per the note the loading dose of Dilantin was administer prior to arrival into the room. Moments later Patient #4 became pulseless and asystole (electrical activity in the heart stops and the heart stop pumping), she did not survive. Patient #4’s medical record revealed Staff K, RN did not document the incident in the medical record. Review of the Policy and procedure title, “Assessment and Reassessment”, reviewed 04/24/2023 ...Any change in the patient’s condition shall require an immediate reassessment with changes in the plan of care reflecting the change in condition ... During an interview on 11/12/2024 at 1:20 PM, Staff Q, Clinical Coordinator said that the nurse did not document the change in condition, reassessment of patient, and the outcome of the patient in the medical record and it should have been there.”

“BLOOD TRANSFUSIONS AND IV MEDICATIONS CFR(s): Blood transfusions and intravenous medications must be administered in accordance with State law and approved medical staff policies and procedures. This Standard is not met as evidenced by: 36678 Based on medical record review, FDA (Food and Drug Administration) website, and interview the facility failed to administer medication per providers order in 1 (Patient #4) of 3 mortality patients. Findings included: Review of Patient #4 medical record, on 10/16/2024 at 3:43 PM Staff H, APRN (Advanced Practice Registered Nurse) ordered a loading dose of Dilantin (seizure medication) 950 mg IV (intravenous) with a maximum dose of 50 mg/minute. Review of the eMAR (electronic Medication Administration Record) Staff K, RN administered the Dilantin IV (intravenous) push (a process of introducing a medication substance directly into the bloodstream at a rapid pace) on 10/16/2024 at 4:00 PM. On 10/16/2024 the Critical care noted revealed Staff L, ARNP arrived to the bedside with the attending and the patient was unresponsive with noxious (painful) stimuli, apneic (temporarily stops breathing), severe bradycardic (slow heartbeat less than 40 minute) and unable to obtain a blood pressure. Per the note the loading dose of Dilantin was administer prior to arrival into the room. Moments later Patient #4 became pulseless and asystolic (electrical activity in the heart stops and the heart stop pumping). Review of the consent for Disposition of Body for Patient #4 revealed the patient expired 10/16/2024 at 4:09 PM. Review of Parenteral Dilantin (Phenytoin Sodium) Injection,USP at https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/008762s050,010151.038lblpdf on 11/18/24 revealed the following: Loading Dose: A loading dose of parenteral Dilantin should be injected slowly, not exceeding 50 mg per minute in adults. Status Epilepticus-In adults, a loading dose of 10 to 15 mg/kg should be administered slowly intravenously, at a rate not exceeding 50 mg per minute (this will require approximately 20 minutes in a 70-kg patient). During an interview on 11/14/2024 at 10:15 AM, Staff T, Patient Safety Coordinator stated Staff K, RN administered the medication at 4:00 PM and she confirmed that the patient expired at 4:09 PM.”

“DELIVERY OF DRUGS CFR(s): 482.25(b) §482.25(b) Standard: Delivery of Services In order to provide patient safety, drugs and biologicals must be controlled and distributed in accordance with applicable standards of practice, consistent with Federal and State law. This Standard is not met as evidenced by: 36678 Based on Food and Drug Administration website, medical record review and interviews, the facility failed to provide safe dispensing of IV (intravenous) medication in 1 (Patient #4) of 3 deaths reviewed. Findings included: Review of Parenteral Dilantin (Phenytoin Sodium) Injection, USP at https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/008762s050,010151.038lblpdf on 11/18/24 revealed the following: Loading Dose: A loading dose of parenteral Dilantin should be injected slowly, not exceeding 50 mg per minute in adults. Status Epilepticus-In adults, a loading dose of 10 to 15 mg/kg should be administered slowly intravenously, at a rate not exceeding 50 mg per minute (this will require approximately 20 minutes in a 70-kg patient). Review of Patient #4’s medical record revealed on 10/02/2024 at 4:34 PM Staff H, APRN (Advanced Practice Registered Nurse) ordered Dilantin 750 mg (15 mg/kg) once to infuse over 5 minutes max rate 50 mg/minute. The order was discontinued by pharmacy, clarified, and rewritten with a verbal order. The new order was Dilantin 750 mg (Dilantin 250 mg/ ml vial) sodium chloride 100 ml (fluid bag) to infuse at 345 ml /hour. Then on 10/16/2024 at 3:43 PM Staff H ARNP ordered the Dilantin 950 mg (15 mg/kg) once to infuse at a rate of 50 mg/minutes (should infuse over 19-20). Review of the eMAR (electronic Medication Administration Record) Staff K, RN administered the Dilantin IV (intravenous) push (a process of introducing a medication substance directly into the bloodstream at a rapid pace) on 10/16/2024 at 4:00 PM. Shortly after, Staff L, ARNP arrived at the bedside with the attending physician and the patient was unresponsive to noxious (painful) stimuli, apneic (temporarily stops breathing), severely bradycardic (slow heartbeat less than 40 minute) and unable to obtain a blood pressure. Patient #4 then became pulseless and asystolic (a life-threatening condition that occurs when the heart’s electrical and mechanical activity stops, resulting in no heartbeat). Per Disposition of Body form, Patient #4 expired on 10/16/2024 at 4:09 PM. During an interview on 11/13/2024 at 1:45 PM, Staff M, Pharmacist stated she called Staff H, APRN to verify the order and Staff H APRN informed her the medication needs to be with a bag of IV fluids. Staff M, Pharmacist informed staff H, APRN that she will change the order in the computer. Staff M, Pharmacist said after the phone call, she was getting ready to change the order in the computer when she received another phone call that made her switch to another medical record. After that phone call, she went back into Patient #4’s medical record and saw the Dilantin order was verified and cleared by Staff N, Outside Pharmacist. During an interview on 11/14/2024 at 9:28 AM, Staff N, Outside Pharmacist, stated she reviewed the order and assumed the medication was going to be given mixed in a saline bag. She did not clarify the order with Staff H, ARNP.”

“PHARMACY: REPORTING ADVERSE EVENTS CFR(s): 482.25(b)(6) Drug administration errors, adverse drug reactions, and incompatibilities must be immediately reported to the attending physician and, if appropriate, to the hospital’ s quality assessment and performance improvement program. This Standard is not met as evidenced by: 36678 Based on facility documents, review of medical record and interviews, the facility failed to report a medication adverse event to the oversight personnel of QAPI (Quality Assurance and Performance Improvement), in 1 (Patient #4) of 3 deaths reviewed. Findings included: Review of the facility Medication Safety Committee QAPI (Quality Assessment and Performance Improvement) showed that the QAPI meeting was provided; October 18, 2023, March 20, 2024, and June 2024. No evidence found in the QAPI (Quality Assessment and Performance Improvement) that the facility informed the Governing Board and Medical Executive Committee of the events that resulted in the death of patient #4. Review of Patient #4’s medical record revealed on 10/02/2024 at 4:34 PM Staff H, APRN (Advanced Practice Registered Nurse) ordered Dilantin 750 mg (15 mg/kg) once to infuse over 5 minutes max rate 50 mg/minute. The order was discontinued by pharmacy, clarified, and rewritten with a verbal order. The new order was Dilantin 750 mg (Dilantin 250 mg/ ml vial) sodium chloride 100 ml (fluid bag) to infuse at 345 ml /hour. Then on 10/16/2024 at 3:43 PM Staff H APRN ordered the Dilantin 950 mg (15 mg/kg) once to infuse at a rate of 50 mg/minutes (should infuse over 19-20). Review of the eMAR (electronic Medication Administration Record) Staff K, RN administered the Dilantin IV (intravenous) push (a process of introducing a medication substance directly into the bloodstream at a rapid pace) on 10/16/2024 at 4:00 PM. Shortly after, Staff L, APRN arrived at the bedside with the attending, the patient was unresponsive to noxious (painful) stimuli, apneic (temporarily stops breathing), severe bradycardia (slow heartbeat less than 40 minute) and unable to obtain a blood pressure. Patient #4 then became pulseless and asystole (a life-threatening condition that occurs when the heart’s electrical and mechanical activity stops, resulting in no heartbeat). Per Disposition of Body form, Patient #4 expired on 10/16/2024 at 4:09 PM. During an interview on 11/14/2024 at 9:28 AM, Staff N, Outside Pharmacist, stated she reviewed the order and assumed the medication was going to be given mixed in a bag of normal saline. She did not clarify the order with Staff H, APRN. During an interview on 11/13/2024 at 2:13 PM, Staff J, Director of Pharmacy stated “they are supposed to do the QAPI quarterly but have not been able to because they had a gap in schedules.” During an interview on 11/13/2024 at approximately 4:00 PM, Staff R, Directory of Quality stated that they did not call an Ad Hoc meeting (spontaneous gathering to address a specific time-sensitive issues that require immediate attention) to discuss the serious event that occurred on 10/16/2024, they have a scheduled QAPI meeting next week.”