The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

MUSCOGEE (CREEK) NATION MEDICAL CENTER 1401 MORRIS DRIVE OKMULGEE, OK 74447 Dec. 21, 2017
VIOLATION: PATIENT RIGHTS Tag No: A0115
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on record review, interview and observation the hospital failed to:

A. Ensure competent care was provided by the emergency department staff to prevent potential serious harm resulting from the increased risk of bleeding in one (Patient #12) of four patients who received intravenous Heparin and high dose Clopidogrel (Plavix), three (Patient #11, 15 and 22) of four patients who received full dose Aspirin immediately preceding the administration of Activase/Alteplase, and three (Patient #11, 12 and 22) of four patients who did not have documentation of the divided dose for Activase/Alteplase .

B. Ensure emergency department staff recognized and appropriately triaged three (Patient #6, 10 and 13) of 22 patients resulting in patients not having access to timely care and treatment. This failed practice had the potential for three (Patient #6, 10 and 13) of 22 patients to have worsening of their clinical condition.

Findings:

A. Competent Care

A review of hospital document titled "Drug Inquiry Report" dated 12/19/2017 showed Alteplase (Activase) was ordered for 10 patients in the preceding 12 months. Seven patients (Patient #11, 12, 15, 22, 23, 24, and 25) received Alteplase and three patients (Patient #26, 27 and 28) showed Alteplase was ordered and then discontinued. The report failed to provide evidence of the 1o% bolus and 90% intravenous (IV) piggyback onto a normal saline (NS) infusion except in one patient (Patient #15).

A review of hospital policy titled "Suspected CVA/Stroke Protocol" dated 02/01/16 showed nursing staff are authorized to implement the protocol based on the patient's stated presentation of facial droop, arm drift, or abnormal speech at the time of symptom onset. Orders include providing oxygen at two liters per nasal cannula if oxygen saturation is below 90%, performance of vital signs, finger stick blood sugar, physician assessment within 10 minutes of arrival, STAT CT scan of the head within 25 minutes of arrival and interpreted within 45 minutes, STAT labs and Chest X-ray and a neurological assessment by the ED physician within 25 minutes of arrival.

A review of hospital document titled "Stroke Thrombolytic Therapy Contraindications Checklist" showed exclusions for administration of therapy included but was not limited to known bleeding diathesis such as platelet count less than 100,000, the receipt of Heparin within 48 hours and an elevated aPTT or receipt of an oral anticoagulant and an INR of 1.7 or greater. The document (form) required review and signatures by both an RN and physician before the initiation of thrombolytic therapy.

A review of hospital document titled "Activase Protocol for Acute Ischemic Stroke" showed Activase should be administered in a divided dose of 10% IV bolus over 1 minute and the remainder 90% over 60 minutes. There is no evidence in document that the infusion should be piggybacked onto an IV solution of normal saline to ensure the medication that remains in the tubing is received. The document showed no anticoagulants or antiplatelets should be given for a minimum of 24 hours.

A review of hospital policy titled "Standing Orders/Protocols" showed all hospital staff should be provided education on standing orders including the criteria used and staff responsibilities.

Review of a hospital document titled "Emergency Department Acute Stroke" showed a CT scan of the head would be read within 20 minutes of it becoming available and if neuro-imaging could not be completed timely it would be completed at the receiving facility.

Review of hospital document titled "Bylaws of Muscogee (Creek) Nation Department of Health (MCNDH) Medical Staff" showed the purpose of the medical staff was to provide quality patient focused care to all patients treated or admitted and provide oversight for care, treatment and services provided by practitioners with privileges at MCNDH.

A review of document titled "Activase Prescribing Information" dated 01/2017 showed administration of anticoagulants (i.e. Heparin) and antiplatelets (i.e. Clopidogrel/Plavix) can interact with Activase and increase the risk of hemorrhage. The concomitant administration of Heparin and Activase has not been investigated and may cause bleeding complications. Anticoagulants and antiplatelets increase the risk of bleeding and Activase should be discontinued if the International Normalized Ratio (INR) is greater than 1.7 or the activated partial thromboplastin time (aPTT) is elevated (normal 22.4-29.8).

A review of a scientific statement titled "Comprehensive Overview of Nursing and Interdisciplinary Care of the Acute Ischemic Stroke Patient" by the American Heart Association/American Stroke Association dated 08/2009 showed there should be no anticoagulation or antiplatelet agents such as Heparin, Warfarin, Aspirin or Clopidogrel administered for at least 24 hours.

A review of a guideline titled "Guidelines for the Early Management of Patients with Acute Ischemic Stroke" by the American Heart Association/American Stroke Association dated 03/2013 showed exclusion criteria for the administration of thrombolytic therapy (Activase) includes Heparin received within 48 hours and an abnormally elevated aPTT greater than normal.

A review of a scientific statement titled "Scientific Rationale for the Inclusion and Exclusion Criteria for Intravenous Alteplase in Acute Ischemic Stroke" dated 12/2015 showed there may be an increased risk in all types of hemorrhage in patients who have been systemically anticoagulated and receive IV Alteplase. Patients who receive Heparin within 48 hours and have an elevated aPTT remains an exclusion criteria for IV Alteplase.

A review of the National Stroke Foundation guidelines titled "Clinical Guidelines for Stroke Management 2010" used as a source reference for hospital policy titled "Emergency Department Acute Stroke" showed that the administration of aspirin should be delayed at least 24 hours after the administration of Activase and completion of a follow up CT scan.

A review of six ED RNs personnel files showed six (Staff F, G, H, J, K and L) of six staff had no evidence of education or competency for the emergency management of an acute stroke patient including the administration and post-management of patient's receiving thrombolytic therapy (Activase/Alteplase).

Patient #11 was an [AGE] year old patient who arrived in the ED at 4:06 pm with complaints of an acute onset of difficulty speaking and expressing what he/she wanted to say. A medical screening examination was performed and it was determined the patient had suffered an acute stroke. CT scan of the head was obtained and negative for intracranial bleeding. Patient was determined to be eligible for thrombolytic therapy (Alteplase/Activase). An order was put into the patient's electronic medical record (EMR) by Staff D (ED physician) for "Alteplase 53.2mg IV injection once STAT" at 5:01pm, and administered by Staff O at 5:16 pm. There was no evidence Alteplase was administered in a 10% IV bolus (similar to an injection) and 90% IV infusion over 60 minutes as recommended by manufacturer instructions, national guidelines, and hospital protocol. Staff D ordered Aspirin 324mg oral at 4:48 pm that was administered by Staff O at 4:57 pm. Administration of antiplatelets such as Aspirin in conjunction with Alteplase is not recommended by manufacturer's instructions, national guidelines and hospital protocols. During and following the administration of Alteplase, the patient's neurological status and signs of bleeding complications were not assessed as recommended per current national guidelines, standards of practice and hospital policy for patients receiving thrombolytic therapy.

Patient #12 was a [AGE] year old patient who arrived in the ED at 2:13 am, with complaints of right side weakness that resolved during work-up. MSE performed by Staff M (ED physician) noted symptoms resolved, no focal neurological deficits observed, diagnosis acute anterior circulation transient ischemic attack (TIA). CT scan of the head, labs, and ECG were obtained. CT of the head was negative for intracranial bleed. At 5:15 am, the patient had a sudden onset of right side weakness and facial droop, medical records show Staff N notified Staff M. At 5:35 am, Staff M ordered Heparin 5,000 units IV and Clopidogrel (Plavix) 600mg oral that was administered by Staff N at 5:38am. Medical records show documentation by Staff M at 5:39 am patient condition unchanged, patient given educational material on TIA and disposition to be transferred to outside facility stroke unit. There was no evidence in the medical record Staff M performed a re-assessment of the patient acknowledging the acute neurological changes in the patient and plan for the patient did not include administration of thrombolytic therapy including administration of Heparin and Clopidogrel. At 6:28 am, Staff M ordered "Alteplase 65.43mg Injection IV, Once STAT". At 6:52 am, Staff N administered. There was no evidence Alteplase was administered in a 10% IV bolus (similar to an injection) and 90% IV infusion over 60 minutes as recommended by manufacturer instructions, national guidelines, and hospital protocol. The Stroke Thrombolytic Therapy Contraindications Checklist had a check mark for the exclusionary criteria of receipt of Heparin within 48 hours and the aPTT not elevated. The checklist was signed by Staff M at 6:24 am, and Staff N at 6:25 am. There was no evidence Staff M or Staff N acknowledged the patient had received Heparin at 5:35 am, and there was no labs performed to determine the aPTT level prior to administration of Alteplase. NIHSS (National Institutes of Stroke Scale) performed by Staff N at 2:29 am, with a score of 0 (0 = no deficits to 42 = severe deficits). Administration of anticoagulants such as Heparin within 48 hours of Alteplase is contraindicated unless the aPTT is not elevated according to current evidence based national guidelines for stroke and thrombolytic therapy. There is no evidence Staff M (ED physician) performed a reassessment of the patient to determine the safety of administering Alteplase after receipt of Heparin and loading dose of Clopidogrel. No evidence Staff N performed neurological assessments prior to administering Alteplase to determine baseline neurological status or during and after administration per recommended guidelines and standards of practice for patients receiving thrombolytic therapy.

Patient #15 was a [AGE] year old patient who arrived in the ED at 1:15 am, with complaints of loss of speech, right side weakness, and facial droop. Staff P (ED physician) performed a MSE and determined patient was having a potential acute stroke. CT scan of head, labs and ECG were obtained. Patient was eligible for thrombolytic therapy and order was placed by Staff P for a 76.5mg IV piggyback Alteplase infusion (90%) at 2:24 am and 8.5mg IV injection (10%) of Alteplase at 2:20 am. Staff Q (ED nurse) administered the IV injection (bolus) at 2:35 am, followed by initiation of the piggyback infusion at 2:36 am. Staff Q noted at 3:24 am, the infusion had completed. Patient transferred to a higher level of care at 3:35 am. There is no evidence Staff Q assessed patient neurological status or signs of bleeding complication during and following the administration of Alteplase as recommended by the current national guidelines, standards of practice and hospital policy for patients receiving thrombolytic therapy.

Patient #22 was a [AGE] year old patient who arrived in the ED at 8:59 am, with complaints of acute onset of left leg weakness and numbness that started at 7:50 am which caused him/her to fall and hit her head on the pavement. Patient also had complaints of a headache. Staff D (ED physician) performed an MSE and found mild weakness in left arm and leg, numbness in left leg, gait off balance and a hematoma on the right side of head. NIHSS performed with total score of 4. CT scan of head, labs and ECG were obtained. Patient was eligible for thrombolytic therapy and order was placed by Staff D for a 62.1mg IV injection Once STAT at 9:57 am and Staff J documented in a "result comment" on the medication administration record" the administration at 10% bolus of 6.2mg at 10:18 am. There was no evidence the remaining 55.9 mg infusion was documented and given over 60 minutes as recommended per manufacturer's recommendations, national guidelines and hospital protocol. Staff D ordered full dose Aspirin 324mg oral at 10:18 am and was administered by Staff J at 10:17am. Administration of antiplatelets such as Aspirin in conjunction with Alteplase is not recommended by manufacturer's instructions, national guidelines and hospital protocols.

On 12/21/17 at 11:34 am, Staff N stated he/she did administer the Heparin 5,000 units IV and 600mg of Clopidogrel to Patient #12 prior to administering Alteplase. Staff N stated he/she was aware of the potential for an increased risk of bleed and discussed with Staff M (ED physician) and received instruction to go ahead and give the Heparin and Clopidogrel prior to administration of Alteplase. Staff N reported the Stroke Thrombolytic Therapy Contraindications Checklist was usually completed by the physician. Staff N stated he/she does not remember if he/she signed the form prior to administering the Alteplase. Staff N stated he/she did not receive education for stroke or administration of thrombolytic therapy at this hospital but had received education at a prior hospital. Staff N stated after receiving Alteplase the process would be to monitor vital signs and neurological assessments every five minutes until the patient was transferred.

On 12/19/17 at 1:35 pm, Staff I stated staff do not receive any formal education on stroke management or administration of thrombolytic therapy. Staff I stated there is not any formal training provide for new employees during orientation for stroke or administration of thrombolytics. Staff I stated nursing staff are not trained to perform the NIHSS and physician staff are responsible for completing the NIHSS on stroke patients. Staff I stated the ED manager would be responsible for ensuring ED nursing staff have education, competencies and looking at missed opportunities. Staff I stated Patient #22 MAR record does appear to show administration of Alteplase 62.1 mg in a onetime injection. Staff D stated the MAR did not show the infusion of the remaining 90% of the Alteplase. Staff D stated he/she was unaware the Alteplase should not be documented as a single injection. Staff D stated there was a comment in the MAR by the assigned that there was a 10% bolus of 6.2 mg given at 10:18 am.

On 12/21/17 at 11:54 am, Staff M stated he/she gave Heparin and Clopidogrel to Patient #12 to prevent clot formation and then called a stroke center to consult on further management. Staff M stated the ED nurse was responsible for completing the Stroke Thrombolytic Therapy Contraindications Checklist. Staff M stated he/she did review the checklist prior to the administration of Alteplase.

On 12/21/17 at 12:46 pm, Staff S stated he/she reviewed the order for Clopidogrel at 7:32 am and Heparin at 7:22 am for Patient #12. Staff S stated these medications could have been given in error. Staff S stated these medications were not reported and reviewed by pharmacy.

On 12/20/17 at 10:02 am, Staff G stated he/she had not had any formal training on stroke management or administration of thrombolytic therapy. Staff G stated another nurse had demonstrated how to mix and administrate Alteplase. Staff G stated he/she was not familiar with the hospital's protocol for stroke. Staff G stated he/she would assess a potential stroke patient's current use of blood thinners (anticoagulants), history of [DIAGNOSES REDACTED]s or intracranial bleeding because these would be contraindications to thrombolytic therapy.

On 12/20/17 at 2:23 pm, Staff F stated he/she has had in-services on stroke management and administration of thrombolytic therapy. Staff F stated he/she does not remember the dates of those in-services and he/she believes the last one was on thrombolytic therapy. Staff F stated he/she would use the hospital's protocol for patients presenting with stroke. Staff F stated only have to have CT scan and blood pressure under control before administering thrombolytic therapy. Staff F stated the age of the patient would be taken into consideration. Staff G stated thrombolytic therapy would only be given within three hours from a patient's last known well time and had never heard of the extended time window of four and half hours for administering IV thrombolytic therapy. Staff F stated he/she would monitor a patient's vital signs and neurological status every 15 minutes and put all patients on oxygen at two liters regardless of blood oxygen saturation. Staff F stated he/she did not know if Aspirin was indicated or not after administration of thrombolytic therapy.

On 12/20/17 at 9:20 am, surveyors observed Okmulgee County EMTs arrive at the nurses' station in the ED with Patient #18 identified by EMTs as a possible stroke. EMTs were observed at the nurses' station attempting to give report to Staff G (ED nurse) who walked pass the EMT. EMTs proceeded to take Patient#18 to open ED room and transfer patient to ED bed. Surveyor heard EMT call out "can I get a nurse in here". At 9:24 am, Staff G came into the room and received report from the EMTs. At 9:29 am, Staff G asked Staff E (ED physician) if he/she wanted to order a CT scan of the head for Patient #18. Staff E stated he/she did want a CT scan and instructed Staff G to take the patient to radiology for the CT scan. At 9:33 am, surveyor observed no staff with the patient rendering care and inquired who was responsible for transporting patient to radiology. Staff E stated he/she did not know. Staff A (COO) stated radiology staff usually responsible for transporting patient and reported nurses can also transport the patient. Staff G stated usually assess patient, get vitals and call CT to come and transport patient to CT. Observed Staff R standing in hallway and was questioned by Staff A where staff for CT was. Staff A instructed Staff R to transport Patient #18 to CT. At 9:40 am patient was transported to CT for exam.

B. Triage and Access to Care

A review of hospital policy titled "Emergency Department Triage" showed the purpose of the policy was to provide instructions for triage using the ESI. The ESI tool is used by experienced ED nurses to rate the acuity of patients from the most urgent resource intensive (Level 1) to the least urgent and resource intensive (Level 5). Emergency (Level 2 major injury or illness but stable) patients should have treatment and reassessment within five (5) to 15 minutes. Urgent (Level 3) patients should have treatment and reassessment within 15 to 45 minutes. Semi-urgent (Level 4) patients should have treatment and reassessment within one to two hours. Routine (Level 5) patients should have treatment and reassessment within four hours. On arrival the RN should evaluate, categorize and document in the patient's medical record the appropriate ESI Level. The policy showed no evidence of instruction on the ESI algorithm using the four decision points to sort patients into the five triage levels based on patient acuity and resources needed. The policy only provided a list of diagnoses for each triage level which is not how the ESI triage level is determined.

A review of hospital document titled "Suspected Chest Pain Protocol" showed staff are authorized to initiate the chest pain protocol for patients who present with complaints of chest pain or other symptoms that may be suggestive of an myocardial (heart) event such neck, jaw, epigastric or arm pain; or non-cardiac sources of discomfort or pressure. A patient should receive an electrocardiogram (ECG - a tracing of the electrical activity of the heart) within 10 minutes of arrival and the RN should notify the ED physician and deliver the ECG for him/her to interpret. STAT labs and chest x-ray should be obtained.

A review of hospital document titled "Nursing Training & In-Service" showed the policy applied to the Muscogee (Creek) Nation Department of Health (MCNDH) requiring nursing staff to participate in education and in-service training provided by MCNDH. There was no evidence the policy provided educational competencies for nursing staff at Muscogee (Creek) Nation Medical Center including but not limited to:
a. ED nursing staff clinical core competencies, emergency patient triage using the Emergency Severity Index (ESI), high risk/low volume clinical conditions such as stroke, trauma, and chest pain
b. Education of ED nursing staff on ED standing orders and protocols including stroke, administration of thrombolytic therapy and chest pain.
c. Annual educational competencies for ED nursing staff

A review of document titled "Emergency Severity Index (ESI) A Triage Tool for Emergency Department Care" Version 4 Implementation Handbook 2012 Edition by the Agency for Healthcare Research and Quality showed that the use of the ESI sorts patients into five levels by evaluating both patient acuity and amount of expected resources needed. The amount of needed resources is an estimation by the triage nurse based on past experiences with patients presenting with similar illnesses or injuries. ESI is a step by step algorithm guiding the nurse to ask questions or gather certain information which will assist in making the triage level determination. There are four decisions points in the ESI algorithm which are crucial for an accurate and reliable determination of triage level. Education of all emergency department staff is critical for successful implementation of the ESI tool.

A review of six ED RNs personnel files showed six (Staff F, G, H, J, K & L) of six staff had no evidence of education or competency for how to triage a patient including education and competency for use of the Emergency Severity Index (ESI) the identified triage tool referenced in hospital policy titled "Emergency Department Triage" and recognized as a current national standard for triaging patients in the ED.

Patient #6 was a three year old patient who was brought to the ED at 2:04 pm, by his/her mother with complaints of fever since yesterday, congestion for one week and ear pain that had started on the day of arrival. At 2:40 pm, Staff L (RN) performed a brief assessment on the patient. Patient had a fever of 100.4 degrees, heart rate elevated at 134 (normal 65-110), respiratory rate of 22 and blood oxygen saturation of 94% on room air. Pain was assessed at a 2/10 using the FACES pain scale for acute ear pain bilaterally. Staff L triaged the patient as a Level 4 (Non-urgent) which according to ESI would only require only one resource. Considering the patient's age and symptoms using the ESI triage algorithm the patient potentially met Triage Level 3 criteria, requiring several resources including obtaining lab, IV to obtain lab and possible IV hydration, possible sedation in order to place IV and lab secondary to patient's age and possible chest x-ray for complaints of congestion. Patient and mother were in the waiting room until 4:09 pm (4 hours) when they left without being seen. There was no evidence the patient had re-assessments every one to two hours by nursing staff during the four hours the patient was in the waiting room.

Patient #10 was a [AGE] year old patient who was brought to the ED by EMS at 8:51 pm with complaints of chest pain, back and mouth pain and headache. It was noted by Staff K "patient has been drinking etoh (alcohol)". Staff K performed an assessment of the patient and noted patient was alert and oriented, had acute chest pain and back pain rated at 9/10 with temperature of 97.5 degrees, blood pressure of 127/90 mmHg, heart rate elevated at 119 (normal 80 to 100), respiratory rate of 20 breaths per minute and blood oxygen saturation of 97% at room air. Staff K triaged the patient at an ESI Level 3 (Urgent) and placed in the waiting room. At 11:41 the patient left without being seen. There was no evidence the chest pain protocol was initiated or an ECG was obtained within 10 minutes of patient arrival. Using the ESI algorithm this patient would potentially meet Level 2 criteria secondary to chief complaint of chest pain with severe pain of 9/10 in the chest and back area. At the hospital's ESI Level 3 criteria this patient should have received treatment and reassessment within 15 to 45 minutes. The patient was in the ED waiting room for approximately three hours and there is no evidence the patient received any treatment or was reassessed during that time.

Patient #13 was a [AGE] year old patient who was brought to the ED by EMS at 11:27 am accompanied by mother and grandmother, with report of falling off the couch and hitting head on floor, dazed and crying. Staff L performed a brief focused triage assessment at 11:43 am, and noted patient to be alert, calm and oriented x 4, a Glasgow Pediatric Coma Scale of 15, temperature of 97.9 degrees, elevated heart rate of 124 (normal 70-110 for toddlers 1-2 years of age), respiratory rate of 22 breaths per minute, and blood oxygen saturation of 96% at room air. Staff L triaged the patient at 11:43 am, and assigned an ESI Level 4 (Non-Urgent) to the patient and placed him/her, the mother and grandmother in the waiting room. There was no evidence from the assessment and triage if the patient's fall was witnessed, the type of flooring, palpation of the toddler's swelling or hematoma formation and comprehensive neurological assessment. Each of these assessment and informational parameters may have elevated the patient to an ESI Level 2 or Level 3 triage criteria. If the patient had fallen onto a flooring surface that was hard (i.e. tile, concrete, wood) this would cause a higher energy impact than a softer flooring surface such as carpet, creating a greater risk of possible traumatic brain injury. Assessment of the patient's head and neurological assessment could have given indications to a more severe injury that could have warranted a higher triage level. Considering chief complaint and patient's age it is possible the patient may require IV sedation in order to obtain a quality CT scan of the head as infants and toddlers can be difficulty to hold still in order to capture the image which would require several resources and a triage Level 3.

On 12/21/17 at 12:07 pm, Staff C stated when patients arrive by EMS they should be placed in an ED bed and in the event no room was available, the process would be to place the patient in the hall. Staff C stated if necessary less critical patients have been moved back out into the waiting room to make room for more critical patients. Staff C reported if a patient arrived by EMS with a chief complaint of chest pain, the process would be to obtain an EKG within 10 minutes of arrival, and if no rooms were available staff would obtain the EKG and triage the patient in the hall. Staff C reviewed Patient #10 electronic medical record (EMR) and stated the patient did have a chief complaint of chest pain who arrived in the ED via EMS. Staff C reported from review of the record the patient did not have an EKG and left without being seen. Staff C stated the patient said he/she had chest pain but it can be caused by other illnesses such as COPD (chronic obstructive pulmonary disease). Staff G stated he/she has had training in the ESI. Staff G reported the triage nurse probably made the decision this patient was not critical.

On 12/20/17 at 3:23 pm, Staff H stated patients who come in by EMS are triaged, vital signs, and report obtained. Staff G stated the nurse back in the ED was usually the nurse responsible for triaging patients coming in by EMS. Staff G reported he/she has heard of patients who have left without being seen after arrival by EMS but it was usually those patients who did not want to come to the ED. Staff G stated he/she had no formal training on how to triage a patient other than following a nurse during orientation. Staff G stated he/she was not aware of the ESI or how to use the ESI algorithm.
VIOLATION: EMERGENCY SERVICES Tag No: A1100
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on record review, interview and observation the hospital failed to:

A. Ensure patients coming to the ED were appropriately triaged resulting in three (Patient #6, 10 and 13) of 22 patients not receiving timely access to care and treatment. This failed practice had the potential for three (Patient #6, 10 and 13) of 22 patients to have worsening of their clinical condition. (Refer to Tag A-0115 B)

B. Ensure ED staff ordered, administered and documented the administration of the thrombolytic therapy (Activase) according to established nationally recognized standards of practice and hospital protocols:

1. Three (Patient #11, 15 and 22) of four patients received Activase and Aspirin

2. One (Patient #12) of four patient received Activase, Heparin and Plavix

3. Three (Patient #11, 12 and 22) of four patients did not have evidence of a correct order and administration for the 10% bolus and 90% infusion of Activase.

These failed practices had the potential to cause serious harm in one (Patient #12) of four patients who received intravenous Heparin and high dose Clopidogrel (Plavix), three (Patient #11, 15 and 22) of four patients who received full dose Aspirin immediately preceding the administration of Activase, and three (Patient #11, 12 and 22) of four patients who had no evidence of an order and administration of the Activase bolus and infusion, thereby increasing the risk of intracranial bleeding. (Refer to Tag A-0115 A)

C. Ensure ED nursing staff performed frequent neurological assessments and monitored for signs of bleeding for four (Patient #11, 12, 15 and 22) of four patients who received thrombolytic therapy (Activase) and, performed frequent neurological assessments for three (Patient #7, 17, and 20) of three patients who were diagnosed with stroke and not eligible for thrombolytic therapy according to established nationally recognized standards of practice and hospital policies and procedures. These failed practices had the potential for neurological worsening in seven (Patient #7, 11, 12, 15, 20 and 22) of seven patients diagnosed with stroke and delayed recognition and treatment of clinical deterioration secondary to bleeding following thrombolytic therapy (Activase) for four (Patient #11, 12, 15 and 22) of four patients. (See below documentation)


Findings:

A. Triage

Refer to Tag A-0115 B

B. Administration of Thrombolytic Therapy (Activase/Alteplase)

Refer to Tag A-0115 A

C. Neurological Assessment and Monitor for Complications

A review of hospital document titled "Activase Protocol for Acute Ischemic Stroke" showed vital signs and neurological status would be monitored following administration of Activase (also known as "the clot buster" or thrombolytic therapy). The protocol failed to establish the frequency for monitoring of the patient's vital signs and neurological status, complications of Activase (bleeding and angioedema) what should be monitor, and how to respond in the event complications should occur.

A review of a scientific statement titled "Comprehensive Overview of Nursing and Interdisciplinary Care of the Acute Ischemic Stroke Patient" by the American Heart Association/American Stroke Association dated 08/2009 showed during and following the administration of thrombolytic therapy (Activase) patients should have their neurological status and blood pressure monitor at minimum every 15 minutes for the first two hours then every 30 minutes for six hours then every 60 minutes for 16 hours for a total of 24 hours. Patient should be monitored for signs of bleeding complications. For patients who do not receive thrombolytic therapy

A review of a guideline titled "Guidelines for the Early Management of Patients with Acute Ischemic Stroke" by the American Heart Association/American Stroke Association dated 03/2013 showed monitoring of patients receiving thrombolytic therapy (Activase) should include blood pressure and neurological assessment every 15 minutes during and after for the first two hours, then every 30 minutes for six hours and then hourly until 24 hours after initiation of treatment. Patient should be monitored for signs of bleeding which includes severe headache, nausea, vomiting, neurological worsening and/or acute hypertension. If patient shows signs of bleeding infusion should be stopped and emergent CT scan obtained.

A review of document titled "Activase Prescribing Information" dated 01/2017 showed after the administration of Activase there is an increased risk of bleed and there should be monitoring for bleeding and if signs of bleeding are identified Activase should be discontinued.

Patient #11 was an [AGE] year old patient who arrived in the ED at 4:06 pm with complaints of an acute onset of difficulty speaking and expressing what he/she wanted to say. Staff O triaged, performed initial neurological assessment, vital signs, and NIHSS at 4:15 pm. A medical screening examination was performed and it was determined the patient had suffered an acute stroke. Patient was determined to be eligible for thrombolytic therapy (Alteplase/Activase). NIHSS performed at performed at 4:41 pm by Staff D. Staff O administered Alteplase at 5:16 pm. Staff O obtained vital signs at 5:32 pm and 6:01 pm but there is no evidence of neurological assessments were performed or the patient was monitored for signs of complications, such as bleeding during the administration of Alteplase prior to transfer.

Patient #12 was a [AGE] year old patient who arrived in the ED at 2:13 am, with complaints of right side weakness that resolved during work-up. Staff N triaged, performed initial neurological assessment, vital signs and NIHSS at 2:25 am. Patient #12 symptoms had resolved and at 5:15 am during re-assessment by Staff N patient developed new onset of right sided weakness and facial droop. Patient was determined to be eligible for thrombolytic therapy and it was administered at 6:52 am by Staff N. Staff N obtained vital signs at 7:00 am, 7:09 am, 7:12 am, and 7:15 am. Neurological assessment was obtained at 2:25 am and 7:09 am. No evidence Staff N performed neurological assessments prior to administering Alteplase to determine baseline neurological status and prior to transfer, and there was no evidence the patient was monitored for complications such as bleeding during the administration of Alteplase prior to transfer.

Patient #15 was a [AGE] year old patient who arrived in the ED at 1:15 am, with complaints of loss of speech, right side weakness, and facial droop. Staff Q triaged, performed initial neurological assessment, vital signs and NIHSS at 2:32 am. An MSE was performed and was determined the patient was having an acute stroke. Patient was determined eligible for thrombolytic therapy (Activase/Alteplase) and it was administered at 2:35 am. Staff Q obtained vital signs at 2:41 am, 2:56 am, 3:02 am, 3:15 am, 3:24 am, and 3:35 am. No evidence neurological assessments were performed or the patient was monitored for signs of complications such as bleeding during the administration of Alteplase or after the infusion was completed.

There is no evidence Staff Q assessed patient neurological status or signs of bleeding complication during and following the administration of Alteplase as recommended by the current national guidelines, standards of practice and hospital policy for patients receiving thrombolytic therapy.

Patient #22 was a [AGE] year old patient who arrived in the ED at 8:59 am, with complaints of acute onset of left leg weakness and numbness that started at 7:50 am which caused him/her to fall and hit her head on the pavement. Patient also had complaints of a headache. Staff O triaged, performed initial neurological assessment and vital signs at 9:07 am. An MSE was performed and was determined the patient was having an acute stroke. Patient was determined eligible for thrombolytic therapy (Activase/Alteplase) and it was administered at 10:18 am. Staff O obtained vital signs at 10:20 am, 10:29 am, and 10:35 am. No evidence neurological assessments were performed or the patient was monitored for signs of complications such as bleeding during the administration of Alteplase or after the infusion was completed.

12/20/17 at 10:02 am, Staff G stated he/she would monitor vital signs and neurological status after administration of thrombolytic therapy (Activase/Alteplase) but was not sure of the frequency. Staff G stated he/she would monitor patients every 5 minutes. Staff G stated he/she was not familiar with the hospital's stroke protocols.

On 12/20/17 at 2:23 pm, Staff F stated he/she would use the hospital's protocol for patients presenting with stroke. Staff F stated he/she would monitor a patient's vital signs and neurological status every 15 minutes and put all patients on oxygen at two liters regardless of blood oxygen saturation.

On 12/21/17 at 11:34 am, Staff N stated after receiving Alteplase the process would be to monitor vital signs and neurological assessments every five minutes until the patient was transferred.
VIOLATION: QUALIFIED EMERGENCY SERVICES PERSONNEL Tag No: A1112
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on record review, interview, and observations, the hospital failed to ensure:

A. adequate numbers of medical and nursing personnel were assigned to the Emergency Department to meet the emergency needs of the 866 patients, who presented to the Emergency Department (ED) from 10/01/17 to 12/20/17.

This failed practice resulted in a delay of care for Patient #18, and potentially resulted in delays of care and potentially contributed to the worsening of patients' health condition due to lack of early intervention for 373 individuals who left without being seen or left against medical advice.

B. staff were qualified to perform competent ED nursing care, such as triage and the management of stroke patients, including the administration of thrombolytic agents as evidenced by lack of documented training for six (Staff F, G H, J, K & L) of six ED RNs and identified patient issues. (See Tag A-1110 for more detailed information)

These failed practices potentially resulted in the lack of an organized, efficient and competently delivered ED services as for the 866 patients seeking ED care from 10/01/17 to 12/20/17 and for the four (Patient # 11, 12, 15, & 22) of four patients who presented to the ED with stroke symptoms and received thrombolytic agent administration.

Findings:

A. Staffing and Census
On 12/18/17 at 1:09 pm, Staff A, Chief Operating Officer, stated Emergency Services consisted of the Emergency Department (ED) and adjacent to the ED was a non-urgent care unit called Fast Track, which was staff by a physician assistant. Staff A stated beginning 08/17, the physician assistant for Fast Track had reduced his/her work hours to approximately one shift every other week.

A review of the untitled documents from 10/01/17 -12/20/17 showed of the 866 patients who presented to the ED, 244 patients were transferred to another facility, and 373 individuals left the Emergency Department without being seen or against medical advice. The documented diagnoses for the patients who left without being seen included, but was limited to: altered mental status, blurred vision, chest pain, head injury due to fall, dizziness with weakness, hypertension with right arm pain, pain in sternal area, shortness of breath, and spitting up blood.

A review of the document titled, "Muscogee Creek Nation Medical Center Daily Data Report 12/01/17- 12/20/17" documented the ED averaged 43 patients per day. The report showed the number of fast Track visits, and the number of patients that left without being seen (LWBS) and left prior to a physician conducting a medical screening exam (LPMSE). The report documented the following data:
*866 patients presented to the ED and Fast Track,
*720 patient presented to the ED,
*126 patients presented to Fast Track for the 11 days it was open out of the 20 day period,
* 97 patients LWBS/LPMSE,
*60 patients LWBS / LPMSE when Fast Track closed,
*19 patient LWBS / LPMSE when the total volume (ED/Fast Track) greater than 41 patients per day.
*78 patients LWBS / LPMSE when total volume (ED/Fast Track) greater than or equal to 41 patients per day.

A review of the document titled, "Committee of the Whole 01/10/17 showed LWBS as 7% and Fast Track LWBS as 1%.

A review of the ED staff schedule for November 2017 showed 11 days in which only 2 staff were assigned to the 7pm-7am in the ED.

On 12/20/17 at 9:07am, Staff E stated the ED had challenging times when nursing staff call in sick. Staff E stated the minimum staffing pattern was to have 3 RNs on duty per 12 hour shift. Staff E stated that patient waiting times were not analyzed.

12/20/17 at 10:02 am, Staff G stated the staffing for the current shift consisted of 1 RN in training, a triage nurse, and 2 RN s. Staff G stated "it gets busy fast-it is nuts."

On 12/19/17 at 9:21 am, Staff D stated when the ED had only one provider, it was a patient matter and one can only do safely what one can do. Staff D stated the medical staff reviewed the reasons patients LWBS, but a review of the Committee of the Whole minutes showed no evidence of a quality evaluation.

On 12/20/17 at 2:53 pm, Staff G stated once the patient arrived in the ED, staff began to figure out how they are going to make room depending on the patient's presentation. Staff G stated the room situation could sometimes be an issue since the ED remained busy. Staff G reported solutions to the crowding have included ambulance personnel holding patients on ambulance stretchers and moving less acute patients out of ED rooms and back out into the waiting room to make room for higher acuity (critical) patients. Staff G stated the major reason for ED diversion was too many patients with higher acuity conditions, such as chest pain. Staff G reported Muscogee (Creek) Nation Medical Center (MCNMC) had used in-patients beds for over-flow in the past for monitoring and observation purposes after everything had been completed in the ED. Staff G stated MCNMC had an issue with a physician wanting to admit a patient but was unable to, because there was no staff in these instances. ED physician had to transfer the patient. She stated the ED staff kept monitoring the patient until the ED physician could make the decision to transfer the patient. Staff G stated patients could get very angry when they were not seen timely, and Fast Track was a "lifesaver" allowing staff to get to the sicker patients quicker. Staff G stated for diabetic he/she did not know why a patient would be transferred verses by admitted .

12/20/17 at 2:23 pm, Staff F stated the ED was very busy every day. Staff F stated the ED had enough nursing staff, but not enough providers to provide patient care coming in. Staff F stated when the Fast Track was open, it definitely helped the flow of traffic in the ED, decreased congestion in the main ED, patient care was better, and the left without being seen (LWBS) dropped significantly.

12/20/17 at 3:23 pm, Staff H stated the patients' waiting time had increased since Fast Track had been closed. Staff H stated patients that had a lesser acuity that would go to Fast Track, but currently were now going to the main ED. Staff H stated staff do not like to fill all the ED rooms up with Level 4 and Level 5 patients, so they keep at least one room open in case a higher acuity (critical) patient came in.

12/21/17 at 12:07 pm, Staff C stated when EMS arrived the patient would be placed in a ED room or if no room was available, would be placed in the hall. Staff C stated EMS sometimes might help monitor the patient. Staff C stated sometimes the staff must move out less critical patient out of a room and place a more critical patient in a room. Staff C stated if EMS brought a patient with complaint of chest pain, the staff ensured the EKG was performed within 10 minutes. Staff C stated if the rooms were full, the EKG would be performed in the hall. Staff C reviewed the EMR for Patient #10, a patient with chest pain who arrived in the ED on 11/26/17 via EMS. Patient # 10's medical record showed the patient left without being seen after triage. Staff C stated that EMS might have told Patient #10 to wait in the waiting room for triage and the ED might have been busy. (A review of the ED Log showed nine other patients were registered in the ED during the time of Patient #10's visit- Patient #10 arrived at 8:51pm and LWBS at 11:51 pm). Staff C stated if he/she had more critical patients than a patient with chest pain, the patient with chest pain would have to sit in the waiting room. Staff C stated sometimes chest pain symptoms were other illnesses such as chronic obstructive pulmonary disease.

A review of the quality report from 01/17 to 07/17 showed the response time for EKG was as follows: 01/17 93.7%, 02/17 96%, 03/17 89%, 04/17 94.8%, 05/17 100%, 06/17 100%, and 07/17 76.4%

12/21/17 at 12:07 pm, Staff C reviewed the medical record for Patient #13, a 19 month (MDS) dated [DATE], with a history of head injury and right eye injury and a history of being dazed Patient #13 was brought in by EMS at 11:27am, triaged, and then LWBS at 1:30 pm. Staff C stated EMS sometimes had to wait in the waiting room with the patient.

On 12/20/17 at 9:20 am, surveyors observed Okmulgee County EMSs arrived at the nurses' station in the ED with Patient #18, a possible stroke patient. At EMT was observed in ED hall attempting to give report to a nurse and the nurse walked pass the EMT. At 9:29 am, an ED nurse asked Staff E if he/she wanted a CT Scan for patient #18, was instructed to take Patient #18 to CT Scan. At 9:33 am, the surveyor asked why Patient #18 had not been taken to CT Scan. At 9:40 am, Patient #18 was in CT Scanner.

B. Competencies
Surveyors requested scope of services or admission and transfer criteria for the hospital in order to ascertain the services provided by the hospital, and none were provided.

A review of a document titled, "Admits by month by Diagnosis 10/17-12/17" included, but not limited to: altered mental status, abdominal pain, chest pain, dizziness, dyspnea (shortness of breath), headache, hyperglycemia, and malaise.

A review of a document titled, "Transfers by month by Diagnosis 10/17-12/17" included, but not limited to: altered mental status, abdominal pain, chest pain, dizziness, dyspnea (shortness of breath), headache, hyperglycemia, and malaise.

On 12/20/17 at 9:07 am, Staff E stated the hospital had not defined admission criteria, and the hospitalist decided on an individual basis which patients would be admitted . Staff E stated the hospital used another hospital's guidelines for stroke management.

A review of six ED RNs personnel files showed six (Staff F, G H, J, K & L) of six staff had no evidence of education or competency for general emergency care, including stabilization and transfer of the patient, triage, stroke management (including neurochecks), and the administration and monitoring of patients who have received thrombolytic therapy (Activase / Alteplase).

A review of six ED RNs personnel files showed two (Staff G & L) of six staff had no evidence of education or competency for the management of cardiac care or trauma.

A review of the policy titled, "Emergency Department Acute Stroke (dated 04/17)" documented the purpose of the policy was to define medical conditions and circumstances for ED patients who may be retained for treatment in-house, required stabilizing treatment, or transfer to another facility. The policy failed to address the monitoring of patient and the management of patients who received (Activase / Alteplase).

On 12/19/17 at 9:21 am, Staff D stated the hospital had no neurology services and patients with suspected stroke should be transferred to a stroke center.

A review of the medical records for four (Patient #10, 11, 12, and #15) of 22 a total sample reviewed showed neurochecks were not performed, and the monitoring for signs of bleeding potentially resulting from thrombolytics or for patient who had a hemorrhagic stroke in accordance to established nationally recognized standards of practice. (See Tag A-1100 )

A review of the medical records for four (Patient #10, 11, 12, and #15) of 22 a total sample reviewed showed administration issues with thrombolytic agents. (See Tag A-0115 A)

A review of the medical records for seven (Patient #10, 11, 12, 15, 22, 23, 24, and # 25) of 22 a total sample reviewed showed documentation issues with thrombolytic agents. (See Tag A-0115 A)

A review of the medical records for three (Patient #6, 10, and 13) of 22 a total sample reviewed showed triage issues. (See Tag A-0115 B )

On 12/20/17 at 9:56 am, Staff G stated he/she had given thrombolytics one time, and had not received formal training. Staff G stated he/she would take the patient's vital signs every 10 minutes and perform neurochecks every five minutes until the patient was transferred, but there was no protocols.

On 12/20/17 at 2:25 pm, Staff F stated he/she did not know if aspirin should be given to a patient who received thrombolytics, but thought the answer was that it should not be given. (Activase instructions for use documented the risk and benefits must be weighed for any patients receiving oral anticoagulants and Activase).

On 12/20/17 at 3:23 pm, Staff H stated he/she had no formal ED training, and the only stroke education she received was from her preceptor during orientation. Staff H said he/she had not received education or had competency assessment for the administration of thrombolytics. Staff H stated he/she was not familiar with the Emergency Severity Index (ESI).