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520 WEST I ST

LOS BANOS, CA 93635

STABILIZING TREATMENT

Tag No.: A2407

Based on interview and record review, the hospital failed to ensure an emergency medical condition was stabilized prior to discharge for two of 14 patients (Pt's) 3 and 5 when:

1. Pt 3 came to the emergency department (ED) on 10/30/23 with a chief complaint of hyperglycemia (high blood sugar) and excessive thirst, blurry vision, frequent urination, and sweet-smelling urine. Pt 3 was also tachycardic (elevated heart rate) and hypertensive (high blood pressure). Pt 3 was diagnosed with new-onset Type 2 diabetes, fluids and intravenous insulin were administered, and Pt 3 was discharged home at 2:54 a.m. on 10/31/23 with a blood glucose of almost 300 mg/dL. Pt 3 did not have access to prescribed medication and follow up care with a physician was not arranged.

These failures resulted in Pt 3 experiencing worsening hyperglycemia and returning to the ED ten hours later with an arrival blood sugar of 423 mg/dL.

2. Pt 5 came to the ED by ambulance on 11/16/23 with a chief complaint of syncope (loss of consciousness for a short period of time, fainting) while driving a vehicle and ended up in a ditch. After emergency medical services (EMS) arrived on scene, Pt 5 became pale and diaphoretic (sweaty) and lost consciousness for ten minutes before being transported to the hospital. Pt 5 was observed in the ED and the decision was made to admit him to the hospital. Pt 5 refused the admission and was discharged without further observation or care. Follow up was not arranged.

These failures resulted in Patient 5 being discharged to home without stabilizing an undiagnosed emergency medical condition and placed Pt 5 and others at risk for harm related to potential recurrence of syncope while driving.

Because of the serious potential harm related to not determining whether an Emergency Medical Condition (EMC) existed for Pt 3 and 5, not stabilizing known abnormal physical assessments and abnormal vital signs and clinical symptoms, and not following up after being aware the patients were discharged from the ED without being stabilized, an Immediate Jeopardy (IJ- a situation in which the provider's noncompliance with one or more conditions of participation has caused or is likely to cause serious injury, harm, impairment, or death to a patient) situation was called for CFR 489.24 - A 2407 (d) Necessary Stabilizing Treatment with the Chief Nursing Officer (CNO) and the Chief Medical Officer (CMO). The hospital submitted an acceptable IJ Plan of Correction (Version 2) on 11/20/23. The following items were listed on the Action Plan and validated by the survey team: 1. Daily Monitoring to occur for 100% of ED patient discharges until re-visit. 2. Implementation of a revised ED patient arrival process to include a collaborative approach between the nurse and the QMP for patient arrival to ensure timely and appropriate MSE. 3. Expanded QMP hours of coverage in the ED lobby from 8 a.m. to 12:00 a.m. daily to ensure timely MSE completion during times of high census, beginning on 11/15/23. 4. ED Nurse Manager/Designee to conduct real time observation to ensure compliance with the revised ED patient arrival process. The revised ED arrival process includes review of the ED medical records and ED tracking board to identify if patient wait times for an MSE are 60 minutes or greater. If the wait time is 60 minutes or greater, the charge nurse or waiting room nurse will inform an available QMP of the need of the support of the MSE process. 5. Chief Medical Executive or designee will conduct retrospective chart reviews to ensure compliance with requesting a formal consult to determine appropriate discharge disposition of ED patients with new complex diagnoses per the consultation requirements as specified in the Memorial Hospital Los Banos Rules and Regulations of the Medical Staff. 6. Facility conducted a root cause analysis for each of the identified deficient practice to address systemic factors that led to the delay in the MSE and stabilization of patients before being discharged in the ED. The following were the factors identified: A. The patient was discharged prior to the stabilization of their Emergency Medical Condition (EMC). B. There was no process in place to schedule urgent follow-up appointments for patients before ED discharge. C. Patient education material was not reviewed with the patient and D. The ED nurse workflow did not include a clear process to escalate and clarify discrepancies between the patient diabetes and insulin administration education materials and the discharge instructions.

On 11/20/23, the components of the IJ Plan of Correction were validated onsite through observations, interviews, and record review. The IJ was removed on 11/20/2023 at 4:15 p.m. with the CNO and CMO.

Findings:

1. During a record review on 11/8/23 at 11:30 a.m., the hospital's report of returns to ED within 48 hours (of a previous ED visit) was reviewed. The report indicated Pt 3 was a 44-year-old woman who came to the ED at 8:33 p.m. on 10/30/23 with a chief complaint of hyperglycemia and was discharged on 10/31/23 at 2:54 a.m. with a diagnosis of "New-onset type 2 diabetes mellitus." The report indicated that Pt 3 had returned to the ED on 10/31/23 at 12:28 p.m. with a chief complaint of "Problem, blood sugar."

During a concurrent interview and record review on 11/9/23 at 11:50 a.m. with the ED assistant manager (EDAM), Pt 3's medical record was reviewed. The record indicated Pt 3 was a 44 year-old woman who came to the ED on 10/30/23 at 8:33 p.m. with a chief complaint of hyperglycemia. Pt 3's vital signs on arrival indicated, pulse 120 beats per minute (bpm-normal 60-100 bpm), respiratory rate 24 breaths per minutes (normal 12-20), blood pressure 179/118 millimeters of mercury (mmHg-normal- less than 120/80 mmHg), weighed 328 pounds with a body mass index (BMI) of 50 (30 or higher is considered obese). Pt 3 was assigned an emergency severity index (ESI) level 3 (ESI- a 5 level scale used by triage nurses to indicate the seriousness of the patient's condition and the resources needed, ESI 1 being the most serious). Pt 3's blood sugar at 8:43 p.m. was a critical value of 402 milligrams/deciliter (mg/dL- normal 70-100). The record indicated Pt 3 was told months ago that she was pre-diabetic and had now developed symptoms of excessive thirst, blurry vision, frequent urination, and sweet-smelling urine. Pt 3's record indicated she had been on 500 mg of Metformin twice daily (an oral medication used to treat Type 2 diabetes); no information in the record regarding who prescribed the medication or how long Pt 3 had been taking it. The record indicated Pt 3 did not have a primary care physician (PCP). Pt 3's medical history included polycystic ovarian syndrome (PCOS), bipolar disorder, and anxiety. Critical value glucose was reported to the ED physician (MD 5) at 8:54 p.m. Lab tests and intravenous (IV- into a vein) fluid were ordered. Pt 3 received an IV fluid bolus of 1000 milliliters at 9:30 p.m. and again at 11:34 p.m.

Review of the lab test results on 10/30/23 at 9:58 p.m. indicated, sodium 129 mmol/L (normal 136-145), glucose 409 mg/dL (70-100), alkaline phosphatase 170 U/L (26-137), AST 94 U/L (0-37), ALT 189 U/L (15-65), a hemoglobin A1c- 11.2 (4.0- 5.6), and the urinalysis indicated Pt 3 had a bladder infection. IV antibiotics were ordered for the bladder infection.

Review of the blood sugar levels, and medication administration record indicated on 10/30/23 at 10:48 p.m., Pt 3's blood sugar was 364 mg/dL and at 11:26 p.m. Pt 3 received 6.5 units of regular insulin IV. At 11:42 p.m., Pt 3's blood sugar was 372 mg/dL. At 1:08 a.m. (10/31/23), Pt 3's blood sugar was 315 mg/dL and Pt 3 received another 6.5 units of regular insulin IV on 10/31/23 at 1:34 a.m. On 10/31/23 at 2:11 a.m. Pt 3's blood sugar was 290 mg/dL.

Review of Pt 3's vital signs indicated on 10/30/23 at 11 p.m. Pt 3's heart rate was 122 bpm and BP was 142/87, and on 10/31/23 at 12 a.m. - heart rate 124 bpm, BP 158/110, and the final set of vital signs were taken on 10/31/23 at 2 a.m.-heart rate 121 bpm, BP 129/89.

Review of the ED Provider Note dated 10/31/23 at 1:36 a.m. reflected Pt 3's ED course including the IV fluids, insulin, and antibiotics given, the blood sugar levels and "Discussed patient with the hospitalist to start her on Metformin 1000 mg bid with 5 units of regular insulin q [every] 6 hours as needed for blood sugar greater than 180. Referred to the Rural Health Clinic for diabetic education program and a primary care provider, go there tomorrow [11/1/23]." The EDAM stated prescriptions for discharge medications are sent electronically to the patient's pharmacy. The EDAM stated the discharge medications ordered by MD 5 were metformin 1000mg twice a day and an antibiotic for the bladder infection, not insulin. The EDAM did not know why MD 5 indicated Pt 3 was to have regular insulin every 6 hours for a blood sugar greater than 180, but did not send a prescription for insulin to the pharmacy.

An electrocardiogram (ECG [EKG]) was completed 10/31/23 at 1:49 a.m., "Abnormal ECG. Sinus tachycardia, non-specific ST and T wave abnormality."

Continued review of the record indicated Pt 3 was discharged on 10/31/23 at 2:54 a.m. with a diagnosis of "New onset type 2 diabetes mellitus" and "Urinary tract infection with hematuria." The EDAM stated the physician selected the discharge instructions within the electronic medical record and the nurse printed the after visit summary (AVS) which included the discharge instructions for the patient. The EDAM stated the physician can also enter their own instructions and those will be printed on the AVS also. Review of the AVS for Pt 3 indicated there were 14 printed pages which included "Diabetes Mellitus Basics" and "Insulin Injection Instructions." There was no indication in the record that the ED nurse reviewed the printed discharge instructions with Pt 3.

Review of the medical record dated 10/31/23 indicated Pt 3 returned to the ED on 10/31/23 at 12:44 p.m. with a chief complaint of "Blood Sugar Problem (Glucose 383 at home, took metformin 45 minutes prior to arrival.)" The record indicated Pt 3's blood sugar at 12:45 p.m. was 423 mg/dl.

During a concurrent interview and record review on 11/13/23 at 2:34 p.m. with the ED manager (EDM), Pt 3's medical record for 10/30/23 was reviewed. The EDM stated regarding the ESI level 3 it is borderline [between a 3 and a 2] because of the abnormal vital signs. After review of MD 5's ED provider note dated 10/31/23 starting at 1:36 a.m. and ending at 2:45 a.m., the EDM stated MD 5's note indicated he consulted with the hospitalist, hospitalist not identified, and no note from hospitalist. MD 5's note indicated insulin would be given along with metformin, but MD 5 did not prescribe insulin. The EDM stated it was her expectation that, as part of the discharge process, the discharging nurse would read the physician's note and if there were differences between the plan as reflected in the note and the discharge instructions, the nurse would confirm the plan with the physician before the patient was discharged. The EDM stated the insulin should have been clarified. The EDM stated she expected the nurse to go over all of the instructions with the patient and to document that in the medical record. The EDM stated she would not discharge a patient with a new diagnosis of diabetes with just printed instructions for insulin injection, that is why the follow up with the rural health clinic (RHC) was so important. The record indicated that the discharge instructions directed Pt 3 to go to the RHC on 11/1/23; Pt 3 returned to the ED the same day she was discharged (10/31/23). The EDM stated "the rural health clinic couldn't get her in the same day, obviously." The record indicated Pt 3's appointment was not until 11/2/23. The EDM stated this would have been a good case for the case manager to have followed up with after discharge to make sure the patient got follow up arranged. The EDM stated the nurse would have to notify the case manager about the patient so she could follow up. The EDM stated as far as discharge vital signs, vital signs are to be taken within 30 minutes of discharge.

During an interview on 11/15/23 at 2:30 p.m. with the EDAM, the EDAM stated the provider lets the nurse know when a patient is ready for discharge. Discharge instructions are verbal as well as written. The EDAM stated as part of the discharge information for the patient, he goes over what was done for them that day, and the provider instructions. The EDAM stated he would read the physician instructions prior to instructing the patient. If the note hasn't been written yet, he talks to the doctor. About Pt 4, the EDAM stated if she (Pt 4) received her insulin and an appointment the day of discharge, it might have saved the patient a return ED trip.

A review of the hospital's policy and procedure "Discharge Instructions for Patients in the Emergency Department," dated 9/10/21, indicated, "...Purpose: to give guidance and direction to assure patients receive appropriate education about their disease/condition, treatment, follow-up instructions, and healthful living as a tool in providing quality patient care...Procedure: A. Assess for readiness for safe discharge...C. Print out after visit summary (AVS) in EHR once determined the patient is ready for discharge. D. Follow up instructions and/or patient information will be given to the patient or responsible person for all patients treated in the ED. E. When giving a patient their written instructions, review the instructions with the patient. Then ask the patient to verbalize the instructions to determine that he/she understands the instructions before leaving the ED. F. Document in the patient EHR the instructions given both in writing and orally, and note the patient's understanding of the instructions upon discharge. G. Provide patient with education about their condition/diagnosis. H. Determine whether vital signs are needed and document as appropriate..."

A review of the article emDOC.net "Management and Disposition of Adults with New-Onset Hyperglycemia without Hyperglycemic Emergency," dated 7/5/21, the article indicated, "...Hyperglycemia in ED patients is frequently unrecognized, undertreated, and poorly communicated...While there is evidence to suggest that discharge with elevated glucose does not result in short-term adverse events, this study does not adequately address safety in the subpopulation of newly diagnosed diabetics...The most important component is establishing rapid follow-up with a physician who can coordinate diabetes education and provide outpatient therapy...The patient's social situation must be considered. For severe elevations and inability to follow up, admission may be required. Rapid acting insulin will only drop the blood glucose for several hours without other therapies, and then the patient is right back where they started..."

2. During a review of the ED During a record review on 11/17/23 the ED Log (the hospital's record of every patient who comes to the ED seeking care) for 11/16/23 was reviewed. The log indicated Pt 5 was a 69 year-old male who was brought into the ED by ambulance on 11/16/23 at 11:29 a.m. with a chief complaint of syncope and was discharged on 11/16/23 at 3:45 p.m.

During a concurrent interview and record review on 11/17/23 at 1 p.m. with the ED manager (EDM), Pt 5's medical record dated 11/16/23 was reviewed. The record indicated Pt 5 was brought into the ED by ambulance on 11/16/23 at 11:29 a.m. after he had a syncopal episode while driving and drove his car into a ditch. The record indicated Pt 5's medical history included diabetes, stroke, atrial fibrillation, and end stage renal disease on dialysis, which he had the day prior (11/15/23). The EMS patient care record (PCR) indicated after the paramedics arrived at the scene of Pt 5's accident, Pt 5 became pale and diaphoretic and had another syncopal episode for approximately 10 minutes, and was hypotensive (low blood pressure). Pt 5 was given intravenous (IV) fluids by paramedics. An electrocardiogram (12-lead ECG/EKG) by EMS during transport indicated atrial fibrillation. Pt 5 taken to room 2. At 11:45 Pt 5 triaged, assigned an ESI level of 3. RN assessment indicated Pt 5 was lethargic, weak, had cool sweaty skin, was arousable by gentle touching/shaking, and had bradycardia (a slower than normal heart rate, less than 60 bpm) with irregular apical and radial pulses. Pt 5's speech was "incoherent and garbled" which Pt 5's wife indicated was baseline for him. Lab tests, imaging and an EKG were ordered. Bed side blood glucose test was 303 mg/dL.
Continued review of the medical record indicated the EKG as interpreted by the ED physician (MD 6) indicated, abnormal EKG, atrial fibrillation, lateral wall ischemia, no acute ischemic changes. Computerized tomography (CT) scans without contrast were done of the head and the cervical spine and were negative for acute findings. Lab test results indicated a critical value creatinine 10.27 mg/dL (range 0.80- 1.40). At 2 p.m., the RN assessment indicated Pt. 5 was arousable by gentle touching/shaking, had cool, clammy skin, and had bradycardia with irregular apical and radial pulses.

Review of the nurses notes indicated at 2:30, "Dr. [name of consulting physician-MD 7] at bedside speaking to patient about admission for observation. Pt refuses to be admitted to the hospital. ED provider made aware."

MD 6's provider note, dated 11/16/23 at 2:43 p.m., listed the results of the imaging, EKG, and lab tests and indicated, "...Driving to an appointment and had a syncopal episode, drove down a ditch...was pale and diaphoretic, also low blood pressure... Pt does not remember the incident..." MD 6 indicated Pt 5's ED course, "Pt was monitored. The patient's condition was discussed with [Consulting physician's name- MD 7] and was examined by [MD 7] and was offered an admission. The patient refused and wanted to go and the patient to be discharged. All risks explained...Final diagnosis: Syncope, unspecified syncope type; Chronic renal failure...Disposition: discharge home...Discharge instructions: To go for dialysis tomorrow..."
The EDM stated there is no documentation in the record from the consulting physician.

A review of a copy of the after visit summary (AVS) given to Pt 5 on 11/16/23 at discharge indicated the discharge instructions, "To go for dialysis tomorrow." The AVS included Public Service Information- general information given to all discharged patients which consisted of instruction/education regarding child safety laws, stopping smoking, suicide prevention, antibiotic medicine, and narcotic (opioid) medication. There was no information or education for Pt 5 regarding syncope, atrial fibrillation, or any other medical conditions and the AVS did not indicate follow up instructions specific to Pt 5, or direction not to drive.

During a review of the P&P "Compliance with Emergency Medical Treatment (EMTALA)," dated 3/22/22, the P&P indicated, "...If a patient refuses to accept treatment, the offered treatment, a summary of the risks and benefits described to the patient as to the refused treatment shall be documented in the progress note. The patient will be requested to sign an AMA form. If the patient refuses to sign the form, the refusal should be documented in the progress notes..."

A review of the hospital's policy and procedure "Discharge Instructions for Patients in the Emergency Department," dated 9/10/21, indicated, "...Purpose: to give guidance and direction to assure patients receive appropriate education about their disease/condition, treatment, follow-up instructions, and healthful living as a tool in providing quality patient care...Procedure: A. Assess for readiness for safe discharge...C. Print out after visit summary (AVS) in EHR once determined the patient is ready for discharge. D. Follow up instructions and/or patient information will be given to the patient or responsible person for all patients treated in the ED. E. When giving a patient their written instructions, review the instructions with the patient. Then ask the patient to verbalize the instructions to determine that he/she understands the instructions before leaving the ED. F. Document in the patient EHR the instructions given both in writing and orally, and note the patient's understanding of the instructions upon discharge. G. Provide patient with education about their condition/diagnosis. H. Determine whether vital signs are needed and document as appropriate..."

During a review of the hospital's document, "Rules and Regulations of the Medical Staff," dated 4/1/21, the document indicated, "...Essentials of a consultation. A satisfactory consultation includes examination of the patient and his/her medical record...In instances of elective [non-required] consultations where the physician of record elects not to abide by the advice of the consultant, he shall proceed according to one of the following: a. Seek the opinion of a second consultant; b. Record in the progress notes his reasons for not electing to follow the consultant's advice...In the instances of required consultation where the physician of record does not agree with the consultant he shall proceed according to the three following methods: a. Seek the opinion of a second consultant; and/or b. if in disagreement with both consultants, he shall abide by their advice; or c. He shall refer the matter to the Medical Staff for final decision...The patient's physician is responsible for requesting consultations when indicated. It is the duty of the Hospital Staff through its Chief of Service and Medical Staff to make certain that members of the Staff do not fail in the matter of calling consultations as needed..."

During a review of the online reference at https: www.ucsfhealth.org "Atrial Fibrillation" accessed on 11/28/23, the reference indicated, ".. An abnormal heart rhythm is a change in either the speed or the pattern of the heartbeat - the heart may beat too slowly, too rapidly or irregularly. When the heart beats too slowly, too little blood is pumped out to the rest of the body. Slow heart rates are called bradycardias...Sometimes the heart's electrical signals can lose their regular pattern. With atrial fibrillation, many parts of the atria, the heart's two upper chambers, start emitting uncoordinated electrical signals. Atrial fibrillation may cause the following symptoms...Fainting, also known as syncope..."