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Based on observation, interview, and document review, the hospital failed to meet the emergency care needs of patients, for 1 of 8 patients reviewed (P1), who presented to the ED with symptoms of stroke and was not properly triaged, assessed, or roomed timely for stroke treatment. As a result, the patient did not receive tPA because the critical time period governing safe administration of tPA expired. The hospital was found not in compliance with Condition of Participation of Emergency Services at 42 CFR 482.55.

The hospital failed to meet the emergency needs of patients in accordance with acceptable standards of practice governing patient triage, initial patient assessment, intervals of patient re-assessment, and appropriate monitoring and rooming of patients who had urgent needs. Refer to the deficiency at 42 CFR 482.55 (b)(2), A-1112.

Based on observation, interview, and document review, the hospital failed to meet the emergency care needs of patients, for 1 of 8 patients reviewed (P1), who presented to the ED with symptoms of stroke and was not properly triaged, assessed, or roomed timely for stroke treatment. As a result, the patient did not receive tissue plasminogen activator (tPA) treatment because the critical time period governing safe administration of tPA expired.

Findings include:

Observations of the hospital's emergency department (ED) on 02/18/16 at 9:00 a.m. established that the ED is comprised of seven pods with a capacity for 74 patients. The center pod is the largest pod. The medication Pyxis in the center pod contained tPA, a medicine used to treat ischemic strokes. Patients who enter the ED via the main ED entrance are greeted at the welcome desk which is staffed with one RN and one care team assistant. The welcome desk RN completes a brief assessment of the patient's problem, which is then referred to the Triage nurse for further assessment. Staff at the welcome desk have the ability to observe patients in the waiting room, as the welcome desk faces the waiting room. Patient triage is located next to the welcome desk and consists of four intake rooms, which are staffed with one to two RNs depending on census. The triage RN is responsible for assessing the patients' condition, identifying the acuity of the patients' presenting problem, and assigning the patient an ESI (emergency severity index) score, an acuity rating from 1 - 5 with 5 being the worst. When the ED's census is at capacity, patients with ESI scores of 1, 2, or 3 remain in the waiting room until an exam room is available. The triage RN is responsible to reassess patients in the waiting room every two hours. The triage nurse continually communicates with the RN Flow nurse, who manages the availability of exam rooms throughout the ED which is based on patient acuity, including acuity changes of patients in the waiting room. At the time of the tour, one RN and one care team assistant were present at the welcome desk, one RN was present at intake for patient triage, and one RN was circulating between exam pods and the intake area. There were no patients waiting in the waiting room.

P1's ED record was reviewed and indicated that P1 presented to the ED by private car on 01/29/16 at 5:05 p.m. P1 was accompanied by family. P1 was triaged at 5:06 p.m. at which time P1 was seated in a wheelchair with her left arm resting on top of a purse in her lap. P1's chief complaint was dizziness which had an onset one hour earlier at 4:00 p.m. P1 told the triage nurse that she had been experiencing periods of left arm and hand numbness for the past two months and had been seen by her primary medical provider (PMD) for this problem several days prior to coming to the ED. P1's blood pressure was 158/99 at 5:13 p.m. The triage nurse assigned P1 an ESI score of 3 and placed P1 in the waiting room. P1 remained in the waiting room from 5:16 p.m. to 7:48 p.m. P1 was roomed in the center pod at 7:48 p.m. at which time P1 had to transfer from the wheelchair onto a gurney. P1 was unable to stand up without help from the room nurse. P1 was weak. The physician came into P1's room while the room nurse was assisting P1 from the wheelchair to the gurney. P1's left arm drifted and fell to P1's side when P1 stood up. P1 stated that her left arm had been unusable like that since 4:00 p.m. The physician activated an acute stroke page at 7:48 p.m. P1's blood pressure was 201/91 at 7:53 p.m. Neurology responded to the acute stroke page at 7:59 p.m. P1 was taken immediately to CT. CT results at 8:11 p.m. were negative for hemorrhage. P1 was having an acute ischemic stroke and was a candidate for treatment with tPA (a protein that breaks down blood clots). P1 was given Labetalol at 8:25 p.m. to decrease P1's "serious" hypertension. The tPA arrived in the ED from pharmacy at 8:33 p.m. but was not given to P1. The critical time period for safe administration of tPA had expired at 8:30 p.m. P1 was transferred to inpatient Stroke Service at 10:30 p.m. for further evaluation and rehabilitation. There was no evidence that the triage nurse assessed P1's left extremity for any deficits, even though P1 reported a recent history of left arm and hand numbness. There was no evidence that the triage nurse assessed P1's balance or problem of dizziness. There was no evidence that P1 was re-assessed during the period of time she waited in the waiting room for two and half hours. Although P1's blood pressure at 5:16 p.m. was 158/99, P1's blood pressure was not re-checked until 7:53 p.m. after P1 was roomed, at which time it had elevated to 201/91.

An interview with family member (FM)/T was conducted on 02/23/16 at 1:27 p.m. FM/T stated that P1 was evaluated by her PMD on 01/25/16 for repeated episodes of her left hand going numb which would last for about five minutes. The PMD noted that P1 was weaker on one side, was possibly experiencing TIAs, and should have a MRI done. FM/T spoke to P1 by telephone on 01/27/16. P1 said her left hand felt weak and she was still having numbness. FM/T went over the symptoms of stroke with P1 and told P1 if she experienced any of the stroke symptoms before the MRI was done, P1 should go to the ED immediately. On 01/29/16, FM/T's sibling called FM/T to report that P1 was going to the ED because P1's speech was slurred, P1 had no use of her left arm, and P1 was using her right arm to move her left arm. FM/T's sibling called ahead and alerted the ED they were on the way with P1 who was having a stroke. FM/T stated she was not one of the family members present with P1 when P1 was in the ED on 01/29/16, but FM/T maintained close phone contact with the family members who were with P1 in the ED. At 6:15 p.m. on 01/29/16, FM/H received a call from the family with P1 in the ED. Family reported that P1 had arrived in the ED around 5:00 p.m. and was checked by a nurse. P1 expressed concern to the nurse that she hoped she wasn't having a stroke. The nurse put P1 in the waiting room and P1 had sat in the waiting room so long that P1 had to use the bathroom. Family tried to assist P1 in the ED bathroom and P1 was so weak P1 could hardly stand up. P1 was leaning way over to the side. P1 was confused and her words were slurred. P1 was afraid she was going to die in the waiting room. At 6:45 p.m. on 01/29/16, FM/T called the ED and spoke to ED Charge RN/U. FM/T identified herself as a registered nurse experienced in cardiac care. FM/T told RN/U that P1 did not have use of her left arm, was leaning when being toileted, and had abnormal speech. FM/H expressed concern that P1 had been in the waiting room for almost two hours and the window of time for stroke treatment with tPA administration was running out. FM/T asked RN/U to "help me out" and get P1 roomed. Around 7:15 p.m., FM/T again communicated with family in the ED and P1 was still in the waiting room. At 7:30 p.m., family in the ED texted FM/T that P1 was "still not seen" and continued to wait in the waiting room. At 7:45 p.m., family in the ED texted FM/T that P1 was being taken back to be roomed. The next time FM/T heard from family in the ED was around an hour later when family reported that P1 was having a stroke but could not receive tPA to treat the stroke because "time had run out." A few days later, FM/T was contacted by MD/H, who apologized and stated that the hospital was conducting a Root Cause Analysis regarding the care P1 received on 01/29/16. An interview with Triage RN/Q was conducted on 02/18/16 at 2:10 p.m. RN/Q stated she is an experienced ED RN of 19 years. RN/Q triaged P1 upon arrival on 01/29/16. P1's family came to the intake area with P1 during triage. P1 was alert and sitting in a wheelchair. P1 told RN/Q she had been dizzy since 4:00 p.m. and felt off balance. P1 told RN/Q she had been experiencing occasions of arm and hand numbness for approximately two months. P1 said she saw her primary medical provider about it a few days ago and the primary medical provider told P1 she needed to have a MRI, which had not yet been scheduled. P1 had no chest pain. P1's speech seemed normal. RN/Q obtained P1's blood pressure, got an EKG, and sent P1 to the waiting room. The waiting room that day had a "yellow light" which meant that more than 15 patients were waiting to be seen. RN/Q did not know why she didn't evaluate P1's left extremity or problem with balance. RN/Q did not know why she didn't reassess P1 or re-check P1's blood pressure during the two and half hours P1 sat in the waiting room. An interview with Room RN/R was conducted on 02/18/16 at 2:25 p.m. RN/R stated that she was P1's primary nurse on 01/29/16. RN/R was waiting in P1's room when P1 was brought back to be seen. P1's family was with P1. RN/R immediately observed that P1's left arm was hanging down low in P1's lap and was "curled funny." RN/R asked P1 if P1 was able to get onto gurney. P1 said, "no, I'm dizzy, can you help me?" Another RN (unidentified) who was nearby assisted RN/R to stand P1 because P1 was so weak. P1 said the dizziness and arm weakness started at the same time, around 4:00 p.m. MD/J came into the room. RN/R immediately told MD/J that P1 had symptoms of acute stroke. MD/J agreed and activated the page for acute stroke alert, which notifies neurology and puts lab and CT on stand-by. All the staff worked quickly to identify the type of stroke P1 was having to facilitate the appropriate stroke treatment. After P1's CT confirmed an ischemic stroke, RN/R gave P1 Labetalol and monitored P1's blood pressure continuously until the tPA arrived in the ED. RN/R stayed with P1 until P1 went to the inpatient floor.

An interview with MD/J was conducted on 02/18/16 at 3:30 p.m. MD/J stated she saw P1 immediately at the time P1 was roomed on 01/29/16. MD/J watched as the nurses stood P1 from the wheelchair to transfer P1 to the gurney. P1 had left-handed weakness, with a severe deficit in the left wrist and hand which flopped down to P1's side. RN/R stated she thought P1 was having a stroke and that P1's symptoms had persisted since 4:00 p.m. It was nearing 8:00 p.m. MD/J was concerned about whether or not P1 was still "in the window" as a potential recipient for tPA administration, which cannot be administered beyond 4.5 hours after the onset of stroke symptoms. MD/J conducted a quick neurological examination and activated the page for acute stroke alert. Neurologist MD/K responded quickly. P1 was taken to CT stat and stat labs were obtained. The CT confirmed that P1 was a candidate for tPA. Pharmacy rushed to mix the tPA but unfortunately, the tPA arrived in the ED three minutes too late and it could not be given to P1. P1 was later transferred to the Stroke floor for further intervention and rehabilitation.

An interview with Neurologist MD/K was conducted on 02/18/16 at 3:00 p.m. MD/K stated his stroke pager went off on 01/29/16 shortly before 8:00 p.m. The pager displayed P1's room number so he went straight to the ED. Two family members were with P1. MD/K administered the stroke scale and obtained a brief history about P1's onset of symptoms. The stroke scale score was low and didn't capture P1's hand weakness because P1 had functional proximal arm movement at the shoulder. P1 was taken to CT stat. MD/K finished his neurological exam of P1 while P1 was enroute to CT. The CT showed no hemorrhage. P1 was having an acute ischemic stroke of non-dominant hemisphere origin. Patients who have this type of stroke do not realize their own deficits. P1 was a good candidate for tPA. Before tPA is administered to a patient, the hospital's protocol is for the Neurologist to confer with another Neurologist regarding the patient's treatment plan and a joint decision is reached. MD/K placed three pages to the on-call Neurologist, who did not respond. MD/K later learned that two physicians had exchanged days of coverage and the on-call list was not updated. MD/K was paging the wrong Neurologist. When MD/K did not successfully reach the on-call Neurologist on 01/29/16, MD/K conferred with MD/L who is the Stroke Center ED consultant. MD/K and MD/L agreed that P1 should receive the tPA. The tPA is reconstituted in Pharmacy by a Pharmacist. The Pharmacy is a brisk ten-minute walk from the ED. By the time the tPA was made and delivered to the ED, it was too late to administer the tPA safely. The tPA can only be administered safely when the medicine is given within a specific window of time, which is 4.5 hours from the onset of symptoms. If tPA is given after the 4.5 hour deadline, the risk of hemorrhage increases every minute beyond the 4.5 hour window of opportunity. MD/K re-interviewed P1 and P1's family about the onset of symptoms and all were certain that P1's onset of symptoms was 4:00 p.m., so a decision was made not to administer the tPA and run the potential risks of hemorrhage.

An interview with Emergency Medicine Chair MD/H was conducted on 02/18/16 at 11:05 a.m. MD/H stated that she reviewed the care provided to P1 on 01/29/16. P1 presented to the ED at a time when there were no exam beds available. Although P1 was triaged immediately, P1's weak hand was not evident to the triage nurse. P1 was having a "hand-nob stroke" which is very pin-pointed and under-captured by the stroke scale. P1's hand deficit was not evident until P1 was roomed several hours after P1 came to the ED. Once P1's hand deficit was identified, an acute stroke page was activated which alerts a Core team of departments for immediate availability, including Neurology, lab, and CT. P1's CT revealed an ischemic stroke and good candidacy for tPA. Ideally, tPA should be administered within 3 hours of the onset of stroke symptoms. The window for tPA administration stops at 4.5 hours after onset of symptoms because the risk of hemorrhage increases significantly for each minute after 4.5 hours. tPA is a high-risk medication. The hospital requires the collaboration of two physicians before tPA is administered. tPA is contraindicated for patients with serious hypertension. P1 was given Labetalol for blood pressure reduction to maintain P1's candidacy for tPA administration. tPA is mixed in the main pharmacy and then delivered to the ED where it is administered. P1's tPA arrived in the ED three minutes beyond the window for safe administration. As a result, P1 did not receive tPA to treat the ischemic stroke. The hospital is conducting a Root Cause Analysis (RCA) regarding P1's care on 01/29/16. Several action issues have been identified with recommended practice changes. Two changes that have already been implemented are the addition of tPA to the ED Pyxis and a back-up neurologist added to the physician on-call list.

The hospital's policy Emergency Department Nursing Triage Procedural Guidelines (undated) indicated that "all ambulatory patients will initially be seen by the Desk Triage RN...patients whose chief complaint warrant immediate attention based on the Triage RN's assessment will be taken directly back to the appropriate patient care area...patients whose chief complaint do not warrant immediate room placement are directly roomed in an open room within the appropriate patient care area. If there are no open rooms then the Triage RN performs a brief assessment which includes vital signs...patients are then placed in the waiting room until an appropriate room is available...patients who present to the ED for care are roomed in an area appropriate to their triage acuity and resource needs...patients awaiting evaluation should be placed in a patient care area, rather than remaining in the waiting room, whenever rooms and staffing resources are available...communication between triage nurses, the charge nurse, and consultants is critical particularly in times of high patient volume..nursing and physician care providers should work together to creatively accommodate high volumes of patients and facilitate their flow through the ED."

The hospital's protocol for Emergency Department Intake Nurse, dated 01/28/16, indicated that the goals of intake included "triage registered patients, identify those that need direct rooming, initiate workup (RN protocols), brief assessment of patient concerns...obtain vital signs and brief reassessment for Level 3 patients who have been waiting for 2 or more hours...can upgrade ESI based on patient assessment...communicate with Intake RNs regarding changes in patient status...confirm appropriate protocols have been initiated."

The ESI Triage Algorithm, V4, identified that a triage score of 2 should be assigned to patients in a "high risk situation or confused/lethargic/disoriented, or severe pain/distress."