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Based on medical record review, interview, and policy and procedure review, the hospital failed to ensure patient rights were honored for care in a safe setting for 1 of 9 patients, Patient #1; the hospital failed to follow current standards of practice when the patient experienced a change in neurological status, was not reassessed, and the physician was not notified of the change in condition. The failure to implement the hospital's stroke alert protocol for patients presenting with new or worsening neurological symptoms resulted in the patient being left in an unsafe situation while in the hospital setting. This systemic failure constitutes an Immediate Jeopardy situation.

Refer to A144 - Patient Rights-Care in a Safe Setting.

Based on medical record review, interview, and policy and procedure review, the facility failed to ensure patient rights for care in a safe setting were honored for 1of 9 patients reviewed for cerebral vascular accident, Patient #1.

Findings:

Review of the medical record for Patient #1 revealed the patient presented to the Emergency Department (ED) on 9/9/2021 at 4:06 PM with a past medical history of atrial fibrillation (an irregular heart beat), cerebrovascular accident (a stroke), hypertension (high blood pressure), valvular heart disease (a condition where one or more valves in the heart do not work properly) and Von Willebrand's disease (a bleeding disorder caused by low levels of clotting protein in the blood).

Review of the Emergency Screening note dated 9/9/2021 at 4:07 PM authored by Medical Doctor #4 (MD) read: "This pt [patient] is a 76 y/o [year old] Female who presents from home with concerns of a stroke. Patient had stroke like symptoms since around 1500 [3:00 PM], including expressive aphasia [difficulty speaking]. Her husband notes her symptoms were similar to her last stroke, however time of her last stroke is unknown. No weakness or numbness, and no vision changes. On aspirin. Has a history of atrial fibrillation but she cannot communicate why she is not on any anticoagulation [blood thinners]. She has a history of Von Willebrand's disease. "Review of the systems for Neurologic read: "no focal weakness, + [positive] aphasia." Physical Examination: Neurologic read: "Alert, normal motor, and sensory exam, has difficulty following finger to nose instructions but she can do it. Has difficulty with some words, no dysarthria [a weakness in the muscles used for speech which can cause slow or slurred speech], no facial droop. The NIH [National Institute for Health] stroke scale score was documented as 2 out of 42." Medical decision making read: "Patient is still in the window for TPA [tissue plasma activator, medicine given for a stroke caused by a blood clot]. However, with low stroke scale [Medical Doctor #3's name] of neurology believes the risk of bleeding secondary to TPA would be worse so does not recommend. Discussed with patient, husband, and daughter (by phone) and they agree. She has had prior bleeding problems on anticoagulation and has had previous Waterman procedure [an implanted device in the heart to prevent blood clots from escaping] so she is not on anticoagulation with her atrial fibrillation."

Review of the CT (Computed Topography) Brain/Head w/o (without) contrast completed on 9/9/2021 at 16:24 (4:24 PM) read: "Impression: No acute intracranial finding."

Review of the Nursing documentation dated 9/9/2021 at 4:45 PM authored by Staff B, Registered Nurse (RN) revealed an NIHSS (National Institutes of Health Stroke Score) of 2 out of 42, with level of consciousness documented as alert, keenly responsive.

Review of MD #4's Progress note at 6:10 PM reads: "Rechecked patient at this time. All vital signs reviewed. The results of diagnostic studies and exam findings were discussed, and the patient expressed understanding of the diagnosis and plan for admission. All questions and concerns have been addressed at this time."

Review of physician orders dated 9/9/2021 at 6:19 PM read: "Admit to inpatient TVRH, [The Villages Regional Hospital] for neurology to [Medical Doctor's name]."

Review of the nursing documentation dated 9/9/2021 at 8:00 PM authored by Staff A, RN revealed a NIHSS score of 6 out of 42. The level of consciousness was documented as alert, keenly responsive. On 9/10/2021 at 12:00 AM the NIHSS remained at 6 out of 42, with the level of consciousness documented as alert, keenly responsive.

Review of the nursing documentation on 9/10/2021 at 1:30 AM documented by Staff A, RN read: "Notification to APRN (Advanced Practice Registered Nurse) systolic blood pressure 180-184, no new orders."

Review of the nursing documentation on 9/10/2021 at 2:00 AM documented by Staff A, RN read: "NIHSS 16 out of 42, with level of consciousness documented as not alert, but arousable by minor stimulation." On 9/10/2021 at 3:51 AM the NIHSS revealed a score of 23 out of 42 with level of consciousness documented as not alert, requires repeated/painful stimulation/obtunded [lessened interest in the environment, slowed responses to stimulation, and tends to sleep more than normal with drowsiness in between sleep states]. On 9/10/2021 at 4:00 AM the NIHSS score was documented as 27 out of 42 with level of conscious documented as not alert, requires repeated/painful stimulation/obtunded.

Review of the medical record documentation on 9/10/2021 at 4:00 AM read: "Notification reason: Neurological change. Provider informed: APRN, Provider requested interventions: call to Neurology. (Patient status worsened) does not follow commands, lethargic."

Review of the nursing progress note dated 9/10/2021 at 4:05 AM authored by Staff A, RN read: "Call to neurologist left message."

Review of the electronic medical record revealed no additional calls to the Advanced Nurse Practitioner or Neurologist between 4:05 AM and 5:59 AM.

Review of the nursing progress note dated 9/10/2021 at 6:00 AM authored by Staff A, RN read: "Call placed to neurology, with symptoms, message to call asap [as soon as possible]. Left message."

Review of the nursing progress note dated 9/10/2021 at 6:30 AM authored by Staff A, RN read, "spoke with [MD #1's name] who was going to see patient and write orders then neuro called. Gave info and orders obtained. [MD #1's name] ordered labetalol [a medicine used to lower blood pressure] 20 mg IV [intravenous] for heart rate and b/p [blood pressure] and cardene [a medicine used to lower blood pressure] drip to keep sbp [systolic blood pressure] less than 180." [Resulting in a delay in medical care and treatment of four hours and thirty minutes].

Review of the nursing progress note dated 9/10/2021 at 6:40 AM read, "Neurology called back, updated on condition, orders received for RAPID [rapid medical assessment]. [MD #1's name] placed orders and notified imaging.

Review of the radiology report dated 9/10/2021 at 7:50 AM read: "CT head without contrast Impression: 1. Interval development of a large left intraparenchymal hemorrhage [bleeding inside the skull, the blood puts pressure on the brain, which can lead to rapid brain damage or death], in the left frontal parietal lobe causing severe cerebral edema with 1.4 cm [centimeters] left to right subfacial herniation [a serious medical condition that happens when brain tissue shifts from the left to the right] and significant downward herniation [when there is pushing or moving upon or from within the cerebral hemispheres - the two division of the cerebellum; the structure located at the back of the brain] with effacement of basal cisterns [the space or cavitiy has been destroyed by the outside growing mass that results by pushing or moving surrounding tissue].

Review of a medical consultation note dated 9/10/2021 at 9:41 AM authored by Medical Doctor #1 read, "I was called by Nurse at 0630 [6:30 AM] for patient who is unresponsive. Patient is having right sided weakness, slurred speech and is hypertensive. I was unable to locate medical attending or neurology on call. Neurology calls back at 07:00 and is recommending stat CT head and CT rapid. 0745 [7:45 AM] Nurse notifies that patient continues to be hypertensive and is now posturing [the involuntary flexion and extension in a patient with severe brain injury] in CT scan. 0830 [8:30 AM] I spoke with the patient's family and informed that the patient had a massive intracranial bleed and mass effect. Grave prognosis death is suspected. Family is declining transfer to Shands and recommending comfort care. [Medical Doctor's name] calls to verify family wishes of comfort care."

Review of the neurology consultation note dated 9/10/2021 at 8:19 AM authored by MD #3 read: "Reason for consult: Stroke, History of Presenting Illness: This is a pleasant patient who we were consulted on for "stroke." Patient initially presented 2 h [hours] after onset of speech difficulty on 9/9. Spoke with ED physician who stated NIHSS was 1 at the time. CT head was unremarkable with the exception of left parietal encephalomalacia [softening or loss of brain tissue] likely old stroke. Physical Exam was documented as Somnolent [drowsiness], Pupils 3 mm-2mm [millimeters], some withdrawal to deep nailbed pressure. Assessment/Plan: Aphasia [loss of the ability to understand or express speech], CVA [stroke]: spoke with ED physician at length and recommended against TPA. Per RN this AM was a change around midnight and primary team was informed that patient unable to verbalize. RN spoke with me this AM and I ordered a RAPID to include Stat head CT/CTA/CTP [computed tomography/computed tomography angiography/computed tomography perfusion - CTA and CTP are imagining procedures which are reported to be of paramount importance in the evaluation of acute storke]. CT head done and shows bleed in the setting of VWD [Von Willebrand disease]."

Review of the Discharge summary read: "Admission information: 76 year old with past medical history of CVA, atrial fibrillation, and Von Willebrand's disease was brought to the ED with difficulty speaking. She had a normal CT head on admission. She had an acute change in mental status. Repeat CT head was done and showed intracranial hemorrhage with cerebral edema and herniation. Hospital course: Neurology was consulted, ER physician discussed about transfer to Shands with the family however because of the patient's poor prognosis family refused transfer or any further aggressive intervention. Patient was made DNR/DNI [Do Not Resuscitate/Do Not Intubate] and comfort measures only per patient's family's wishes. Hospice was consulted and accepted the patient. Patient was discharged to hospice on September 12. Physical Exam: Neurologic: obtunded, unresponsive, and not following commands. Discharge diagnosis: ICH [Intracranial hemorrhage causing cerebral edema and herniation], AMS [altered mental status] secondary to above, A fib RVR [atrial fibrillation with rapid ventricular rate], Von Willebrand's disease, E coli UTI [Escherichia coli urinary tract infection] and fever."

During an interview conducted on 11/22/2021 at 11:35 AM the ED Director stated, "When patients are admitted and held as an inpatient, they are under the care of the attending physician and the ED physicians will not generally need to intervene unless there is an emergency such as a code. There is an inpatient process and an emergency process for calling a stroke alert. We do have an inpatient critical assessment team for emergency situations. I was not aware that there was any delay in having a physician call back. It is my expectation that any changes in a patient's neurologic condition are reported to a physician, that staff follow all policy and procedures for reporting changes, and calling a stroke alert. All patients waiting for a bed would need the hospitalist called. I have not spoken directly to the nurse to determine why she did not make any other calls. I do not know why this wasn't done. All ED staff are trained in the protocols for Stroke Alert. Our staff would not need to call a CAT [Critical Assessment Team] team as we have physicians, and they get them immediately when they need to. I cannot say why she did not escalate to the ED physician. I cannot say if or why she did not escalate the problem to the charge nurse."

During an interview conducted on 11/22/2021 at 1:10 PM, the Risk Manager stated, "I am not aware of an incident report related to lack of physician response or any delays in care related to any patients being held in the Emergency Department while they waited for bed placement. There had been a stroke alert called earlier in the patient's stay. The physicians were aware of the symptoms. The ED physician had reached out to the neurologist and based on the NIHSS, she was not a candidate for TPA. The nurse continued to perform assessments, she reached out to the ARNP and reported the change in neurological status. She did call the neurologist as ordered. There was no answer. There is no indication in the record that another call was attempted until 6:00 AM and there is no indication in the record that the covering nurse practitioner was notified that the neurologist did not call back. There are policies to call a Code Stroke Alert with neurological changes. We do have a CAT team that could have been called and there is an escalation procedure. There is a physician in the ED at all times and they can assist if needed. I am not sure why these were not utilized. I would expect that any delay in care have an incident report filled out for us to determine why the delay in care occurred and let us track and trend any delays related to physician response to calls. This would allow us to determine if there were any additional delays in care for neurological changes."

During an interview conducted on 11/22/2021 at 1:25 PM the Stroke Coordinator stated, "We do have a stroke alert protocol for both ED patients and those that have symptoms as an inpatient. Stroke patients all present differently and after diagnosis can have waxing and waning symptoms. I can't begin to tell you why a stroke alert was not called. I would think it was the nurse's professional judgement that it was not needed. She was assessing the patient, conducting NIH scores doing vitals hourly. I have not reviewed the chart in detail. I was not aware that there was any difficulty getting a neurologist to call back. I just can't tell you why. I am not the nurse who took care of her. Our inpatient stroke protocol is comprehensive and does list reasons for activation of a stroke alert. The patient did meet those requirements."

During an interview conducted on 11/22/2021 at 2:17 PM Staff B, Registered Nurse (RN) stated, I was the nurse at triage the day [Patient #1's name] arrived. She was a stroke alert, according to EMS. She presented with aphasia, she went into a bed and then she went to CT scan very quickly. I did complete the NIHSS when she was in CT scan. We don't wait to get that before the CT scan. I also work in the back, so I am not always the triage nurse. If a patient has new symptoms while they are in the ED we get the physician, call a stroke alert, and get the CT scan completed. We do have patients on hold in the ED waiting for beds. Once they are admitted, we usually get the attending or whoever is on call for them. I report any new symptoms when they need to be reported. If I had increasing NIHSS scores I would call the hospitalist or whoever was on call for them. Depending on the severity of the problem. I would wait 5-10 minutes and then get the ED doc. If an attending told me to get the neurologist and they had not called back, I would call the attending back to let them know. If they didn't respond that is when I would get the ED doc who was on to evaluate the patient. I would only wait 5-10 minutes if anyone that had a CVA and had worsening symptoms."

During an interview conducted on 11/23/2021 at 8:25 AM Staff A, RN stated, "I was caring for [Patient #1's name] as she was waiting for a bed on the neurology floor. She did have an increased NIH stroke score and became lethargic. I was concerned about her and called her attending and spoke with the ARNP, she told me to call neurology. I placed a call at about 4 AM, he did not return the call. I attempted again at about 6 AM and he still did not return the call. I finally got the ED physician to evaluate her about 6:30 AM. She had been experiencing worsening NIH stroke scores and was lethargic with facial drooping. When I came on, she was alert, but her NHI stroke scores were going up and I did see an increase of her scores about 2 AM, which was after the time I called the ARNP about her elevated blood pressure. I know I called the ARNP about her blood pressure. I don't know if I told her about the increase in NIHSS scores. Maybe I should have recalled the ARNP at 2:00 when her scores were worsening. I should have gotten her evaluated earlier. I did not re-call her attending or the ARPN and let them know that she had worsened. I should have. I just didn't think about getting the ED doctor because she had already been admitted. I do know there is a Stroke Alert and CAT team. I really should have called them. I'm not sure why I didn't call. I was waiting for the neurologist to call back. I did have other patients to take care of, when a patient is holding for a bed, we still get patients from the lobby. We are not just assigned ED holds. We usually take care of five patients. I really can't remember how many patients I had that night; I can only tell you that we usually get an assignment, and we can have both admitted patients and those coming in for treatment. I really should have called the ARNP back and let her know that neurology had not called back. I would have gotten the ED doctor right away with the changes I saw if she hadn't been an admitted patient. I did call the ARNP right away and I did call the neurologist right away when she was lethargic and only responded to painful stimuli. I don't know why I didn't call again. I don't know why I didn't get the ED doctor sooner. I really should have. I didn't think to call a stroke alert, we always have a doctor in the ED, and we just get them. I am so sorry that I didn't call sooner, I should have. I did not let the charge nurse know what was going on. I probably should have, but I just didn't think about doing that. I have been an ICU [intensive care unit] nurse prior to being an ED nurse. I know about stroke alerts and CAT calls. I just really didn't think to call them. I really should have, but I just didn't think to. I did not inform the charge nurse or the house supervisor that I couldn't get in touch with the neurologist."

During an interview conducted on 11/23/2021 at 8:45 AM Medical Doctor #1 stated, "I had just come on shift when I was alerted that a patient holding in the ED had worsening stroke symptoms, had them for several hours and staff were unable to get in touch with the neurologist. I went to the patient's bedside and called the neurologist on his cell phone. I know he called back quickly; everything was happening at once. I was reviewing her record, what testing had been completed and assessing her. I remember that she was aphasic and hypertensive and unresponsive when I arrived. I was told that she had been awake and alert upon presentation. I honestly can't remember if a code stroke alert was called then. A Stat head CT was ordered. I was speaking with staff, the neurologist, and the family at some point also. I will assist any patient that is in the emergency room whether they are admitted or not, we are often called to assist when a patient decompensates. If a patient is admitted we encourage the staff to reach out to the attendings, but if that failed, we will and should assist staff for the safety of the patients. I would expect any of the nurses to call a code, if necessary, to get a stroke alert called if there is any decompensation or deterioration in a patient's neurological status immediately. I would expect that staff would get us if any patient in the ED decompensates. We would encourage staff to reach out to the hospitalist if the situation was not emergent, but we will and have intervened in emergencies. I would say that a decompensation in a patient with stroke is an emergent situation and I would expect the staff to let me know. I spoke with the family, her daughter was an APRN in an ED in New York. I actually showed her the CT scan results so she could see them for herself. This was a massive ICH [bleeding in the brain casued by the rupture of a damaged blood vessel in the head] with herniation. She [Patient #1's step-daughter] understood that there would be little chance of any meaningful recovery, and they decided against transferring her to Shands for any neurosurgical interventions. "

During an interview conducted on 11/23/2021 at 10:00 AM, MD #2 stated, "I was consulted for [Patient #1's name] when she presented to the ED. She had a head CT which revealed an old CVA with no acute bleed. Her NIHSS was 1 or 2 when she arrived, and we decided she was not a candidate for TPA based on her NIHSS score and she did have a bleeding disorder. I did not receive any calls overnight about her and any deteriorating neurologic changes. The first call I received was from [MD#1's name] at about 6:20, maybe 6:30 AM. I called right back within minutes. I spoke to [MD #1's name], then I spoke to the nurse [Staff A's name]. I should have been notified when the patient began to have any deterioration in status. Well, given that she had an NIHSS of 2 when she arrived a change in her score of 6 or more should warrant a call to me. I understand that they were not calling the correct number for me. The office number they were calling was not linked to me and that has been corrected now. When [MD #1's name] called my cell phone I responded immediately. I would have ordered a Stat head CT when they observed the changes, but we do have a stroke alert that could have been called. I expect staff to know and understand the resources. They have the CAT team and the Stroke Alert. In the unusual event that staff are not able to contact myself or my partner, I would expect that they call a Stroke alert."

During an interview conducted on 11/23/2021 at 1:45 PM MD #3 stated, "I was the provider on 9/9/2021 through 9/10/2021 overnight working in the emergency department. I was not informed of an ED hold patient having worsened neurological symptoms. We will absolutely intervene when any patient is coding or presenting with new stroke like symptoms. A stroke alert would be called, NIHSS completed, radiology would clear CT and the patient would get an emergent head CT. We will refer staff to the attendings once they have been admitted, but in any emergency, we would respond for the safety of the patient. I would expect that the staff get me if they are unable to reach a different provider. A stroke alert should have been activated."

During an interview conducted on 11/23/2021 at 3:30 PM the Advanced Practice Registered Nurse (APRN) stated, "I don't remember any prior calls before the call when I asked the staff to call the neurologist and activate a stroke alert. It is my routine to tell staff to activate a stroke alert and notify the neurologist. I would expect that I get a return call if those things were not done. I would expect to have a stroke alert called when a patient experiences any change in their neurological status. I do not work for the attending. I cover for the hospital group and ID [Infectious Disease] group. It is a standard of practice to call a stroke alert and get a stat head CT. So, I don't think I ordered the head CT, just told her to activate the stroke alert and call the neurologist. I would not really get a call back, because the specialist, the neurologist would take over in the event of any changes in neurological status and a positive head CT. They would give any additional orders for any interventions they wanted."

During a follow up interview conducted on 11/23/2021 at 3:40 PM the APRN stated, "I was called about her, I truly cannot remember any call about her blood pressure specifically. I get many calls each night for blood pressure, but I was called about a change in her neurological status. I can't remember the time I was called. I remember being told that she was hypertensive, lethargic with facial droop. I did tell staff to notify the neurologist. I did not receive any other calls about her. They did not notify me that they could not reach the neurologist. If they had called me again and told me, they could not reach the neurologist I would have told them to activate a Code Stroke alert and that would have a standing order to get a Stat Head CT."

Review of Policy #3786, effective date 4/14/2021, titled, "Stroke Patient Care" was reviewed and read: "Standard/Purpose: To establish safe, effective medical and nursing management for the Acute Stroke Patient following clinical practice guidelines. Criteria for stroke alert ...signs and symptoms to include (but not limited to): sudden numbness or weakness of face, arm, or leg, especially one side of the body, sudden confusion or trouble speaking or understanding speech, sudden trouble walking, dizziness or loss of balance or coordination, sudden trouble seeing in one or both eyes, sudden severe headache with no known cause, sudden loss of consciousness, syncope seizure. Policy: ... Patients In-House Presenting with Stroke symptoms: healthcare personnel are expected to call extension 222 and request a CAT (Critical Assessment Team) Team/Code Stroke Alert response with location for any in house event. The CAT procedures for stroke are then implemented (refer to separate policy for CAT Response)."

Review of Policy #2743, titled, "Change in Patients Condition," effective date 7/16/2020, read: "Standard/Purpose: Notify physician when the following changes in patient status occur. Procedure: ... C. Neurological change in mental status, abnormal pupil reaction, changes in motor responses or seizure activity.

Review of the policy titled, "Critical Assessment Response (CAT)/Condition Help Policy #789," revision date 5/26/2021, read: "Purpose: To establish a procedure for rapid assessment of an inpatient with an acute status change. The goal of the Critical Assessment Team (CAT) is to improve inpatient outcome by providing a means for rapid and timely intervention of a declining patient. The CAT team is covered under the ACLS guidelines and can begin early intervention in a crisis situation. The purpose is to offer support to nursing staff, within the hospital, to call for help before the situation turns critical. Policy: .... For in house Code Stroke Alert: If patient is demonstrating signs and symptoms of a stroke, such as sudden loss of vision, loss of balance, unilateral weakness in any extremity or the face, slurred or change in speech, and/or the worst headache of their life, initiate CT-Code Stroke .... The Code Stoke Alert Power plan will be initiated in CERNER. The CAT team leader will start to perform and document the NIH stroke scale and prepare the patient for CT scan of brain. Do not delay CT for completion of the NIHSS: this can be completed during transfer and in CT."

Review of Policy # 1366 titled "Chain of Command for Patient Care (Escalation of Concerns)" effective date 10/15/2020, read, "Standard/Purpose: The team member caring for a patient functions as an advocate and follows a chain of command to address issues related to patient care. Policy: For Issues Related to Patient Health Concerns: 1. If the team member caring for a patient has significant concerns for the health and wellbeing of the patient, he/she is to initiate a CAT response team notification as appropriate. In the event the patient does not appear appropriate for a CAT response team notification, the team member is to consult with the charge nurse/immediate supervisor and initiate a call with a request to the appropriate physician to address the situation. 2. If the physician is unavailable, or if the physician responds and the team member continues to have significant concerns, the team member/supervisor is to consult with the department director, clinical manager, administrative supervisor or the risk manager or risk manager on call if after hours. The appropriate physician is to be informed that the team member continues to have significant concerns. The appropriate physician may or may not be the attending physician. In the event the physician is not the attending, the attending physician is to be notified and informed. ...6. An event report to Risk Management is to be completed in MIDA by the end of the shift by the nurse involved or the house supervisor. Include in the report all of the steps taken to resolve the issue. 7. The intent of this standard is to provide the team member with a means to resolve patient care concerns when medical care is being provided to a patient."