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Based on document review, interview, and policy review it was determined that the facility failed to comply with the requirements of 42 CFR 489.24 [special responsibilities of Medicare hospitals in emergency cases], specifically the failure to provide stabilizing treatment in 1 of 20 patients (#1), see 2407; and the failure to obtain transfer consent explaining risks associated with transfer for five of five patients (#8,#15,#16,#17, #18) reviewed for transfer from a total sample of 20, see 2409.

Based on document review, interview, and policy review the facility failed to provide stabilizing treatment to one (#1) of twenty patients during a emergent medical condition resulting in the potential for an adverse patient outcome. Findings include:

A review of patient #1's medical record occurred on 3/12/2018 at 1500. Patient #1 was a 61-year-old male presenting to the emergency department (ED) via ambulance on 3/5/2019 at 1138 with the chief complaint of hyperglycemia and fatigue. Review of the emergency medical services (EMS) ambulance run sheet for patient #1 revealed his complaint was listed as hyperglycemia with primary symptom of weakness. The primary impression was listed as hyperglycemia. The narrative EMS summary states, "CC (clinical complaints) of hyperglycemia, pt. (patient) states he has felt very weak and lethargic for the past three weeks, patient had not seen physician during this time, pt states during the past three weeks he also had increased urination and increased thirst, on arrival pt appeared very lethargic, pt had fruity smell to his breath, pt has no history of diabetes, pt has BGL (blood glucose level) of 525, normal saline fluid bolus was administered, 250 ml (normal saline) were administered by the time pt arrived at hospital, cardiac monitoring showed normal sinus, priority 2 transport to (facility) ER and transferred care to RN (registered nurse) without incident." Vital signs obtained at time of onboarding of patient to EMS transport 3/5/2019 at 1105 were as follows: blood pressure 166/100, pulse 80, respirations 18, oxygen saturation 98 percent on room air, blood glucose 525. The EMS documented arrival and disposition of the patient to the ED as 3/5/2019 at 1135.

According to the triage nurse's documentation the patient was noted with a bedside blood glucose level of 546. temperature of 97.8 degrees Fahrenheit, heart rate 76, respiratory rate 18 breaths/minute, blood pressure 164/93, oxygen saturation of 98 percent on room air. The patient had initial labs drawn and collected on 3/5/2019 at 1158. The patient was then placed in the general emergency department (ED) waiting area. The patient was triaged as a priority 3 which is considered urgent.

The patient's blood glucose levels were documented as follows during his course of the ED portion of his stay:

3/5/2019
Time Glucose level
03/05/19 1138 525 (arrival)
03/05/19 1321 894 (critical lab)
03/05/19 1451 546 (beside point of care)
03/05/19 1457 707 (critical lab)
03/05/19 2008 281 (bedside point of care)

The patient's blood pressure was documented as follows during his course of the ED portion of his stay:

03/05/19 1404 207/93 (H)
03/05/19 1416 167/109 (H)
03/05/19 1430 182/87 (H)
03/05/19 1600 142/83 (H)
03/05/19 1630 157/85 (H)
03/05/19 1730 160/80 (H)
03/05/19 1800 127/76
03/05/19 1700 137/81
03/05/19 1836 120/75
03/05/19 1908 134/70
03/05/19 2046 128/67


According to the medical record of patient #1, the patient entered the facility at 1138, was triaged at 1148, and labs were drawn at 1158. The patient's critical blood glucose was called to the ED at 1321 to staff X. Staff U performed the medical screening exam at 1408 and reviewed the patient's plan of care with staff T. The patient was started on an insulin drip per protocol at 1544. The patient did not receive insulin to address his medical emergency of hyperglycemia for two hours and twenty-three minutes from the time his critical blood glucose level of 894 was communicated to staff X, the ED registered nurse (RN).

On 3/13/2019 at 1045 a document review occurred of the medical record of patient #1. The medical record failed to have documentation the critical blood glucose result was communicated to medical staff by staff X, the RN documented as receiving the critical lab result. Staff G, the Administrative Director of the ED was queried if documentation of how the information was communicated to the Medical staff. Staff G stated, "Yes. That is our protocol."

The history and physical as documented by staff U, the physician assistant stated the following, "61 yo (year-old) male with a medical history significant for CAD (coronary artery disease), MI (myocardial infarction - heart attack) x 3, primary endomyocardial fibrosis cardiomyopathy, hx (history) of colon cancer, PVD (peripheral vascular disease), HLD (hyperlipidemia - high cholesterol), HTN (hypertension - high blood pressure), fibromyalgia, COPD (chronic obstructive pulmonary disease), asthma, and arthritis who presents to the ED with complaints of lethargy and tiredness. Pt states he's been feeling more tired and lethargic for about 3 weeks. His wife states he has lost 30-40 lbs in about a month. He admits to vision changes, flashes of light. He had his eye exam 6 months ago and got new glasses, but his vision has changed since and he doesn't feel like he can wear his glasses now because of the vision changes. He has also noted he extremely thirsty, dry mouth and excessive urination. Some chills, dizziness, lightheadedness. Pt states he has been told he is pre-diabetic but has never taken meds for it. Pt is currently taking metoprolol, norvasc and lisinopril and his BP (blood pressure) has been running in the high 90's. Denies fever, chills, N/V/D/C (nausea/vomiting/diarrhea/constipation), chest pain, SOB (shortness of breath). He takes 1-2 methadone 10 mg tabs prn per day. His PCP prescribes it." The patient's active problem listed included, DKA (diabetic ketoacidosis - hyperglycemia - high blood sugar), personal history of rectal cancer, encounter for colonoscopy following surgery for rectal cancer, history of radiation therapy, history of chemotherapy. The patient's past medical history was listed as arthritis, asthma, cancer colon, chronic pain (back, hands, knees), COPD (chronic obstructive pulmonary disease), coronary artery disease, fibromyalgia, hearing loss (decreased with no aides), history of chemotherapy, history of radiation therapy, hyperlipidemia (high cholesterol), hypertension (high blood pressure), myocardial infarction (heart attack) x 2, neuropathy (legs and hands), peripheral vascular disease, personal history of rectal cancer, primary endomyocardial fibrosis cardiomyopathy, stented coronary artery x 2, and vision abnormalities.

On 3/13/2019 at 0940 an interview occurred with staff T, the ED attending physician for patient #1. Staff T was queried about patient #1. Staff T stated that she became aware of the patient's hyperglycemia after the patient was roomed around 1400. She stated staff U, the physician's assistant, conferred with her about the critical glucose value and the orders were placed for the patient to be placed on the hyperglycemic advanced order set. Staff T was then asked if she was aware of the time the patient arrived at the hospital and how long the patient had waited for his medical screening examination. Staff T stated it was not brought to her attention that the patient was in the ED waiting area but did state that after review of patient #1 medical chart that labs were drawn at the time of triage. Staff T was then queried about STAT (without delay; immediately) labs. Staff T was asked what the normal turn around time was for STAT labs. Staff T stated, "generally it is about one hour ...that is not uncommon and is actually the normal amount of time at all hospitals for STAT labs." Staff T was then queried when she was made aware of the patient's critical blood glucose level of 894 which was called to staff X at 1321 on 3/5/2019. Staff T responded she was not aware of the patient's critical blood glucose level until staff U, the physician assistant had reviewed the case with her after the patient's medical screening exam which occurred at 1408.

On 3/13/2019 at 1020 an interview was conducted with staff W the director of laboratory services. Staff W was queried about the timeliness of STAT lab orders. Staff W explained that STAT labs are generally resulted within 30 to 40 minutes of receiving the samples. Staff W further stated, "if a critical lab value is resulted the lab runs the test again to confirm prior to calling a critical result." Staff W was asked if this was the process for all critical results. Staff W stated, "yes ...we confirm all critical values prior to calling the results." Staff W was asked to explain the process of calling critical lab values. Staff W explained critical values are confirmed and called to nursing staff. A log is kept of the nurse receiving the result and the result is required to be read back to the lab employee by the nurse. Staff W explained it is then the responsibility of the nurse receiving the information to communicate the result to medical staff. Staff W was then asked if he had documentation of the critical blood glucose result of patient #1 being called to nursing staff on 3/5/2019. Staff W stated the critical result was called at 1321 on 3/5/2019 to staff X, an ED registered nurse (RN).

An interview was conducted on 3/13/2019 at 1100 with staff V, the ED RN assigned to patient #1. Staff V was queried about patient #1. Staff V stated he remembered the patient because he remembered how upset the patient's wife was when the patient was brought back to the treatment area. Staff V stated that he received orders from staff U to start insulin on the patient at 10 units an hour, but those orders were canceled, and the patient was then put on the hyperglycemic advanced order set. Staff V was asked about the hyperglycemic advanced order set. Staff V stated the order set is treating the patient with hyperglycemia with IV insulin and frequent checks of the patient's capillary blood glucose. Staff V was then queried if he had been made aware of the patient's critical blood glucose results. Staff V stated he was not the nurse that received the critical lab value, but he did have orders to acquire bedside blood glucose readings. He also stated that fluids were restarted on the patient per physician orders. Staff V was queried when the medical screening occurred for patient #1. Staff V stated that staff U assessed the patient when the patient was roomed around 1400 on 3/5/2019.

On 3/13/2019 at 1140 an interview was conducted with staff U, the physician assistant assigned to patient #1. Staff U was queried if he remembered patient #1. Staff U stated, "yes. He was a patient that was in diabetic ketoacidosis (DKA)." Staff U stated the patient had a critical blood glucose of 894. Staff U stated that he assessed the patient and consulted with staff T, the attending physician. Staff U stated that he originally ordered ten units of insulin per hour with normal saline to address the patient's blood glucose and dehydration. Staff U stated after he reviewed the patient with staff T, the decision was made to use the hyperglycemic advanced order set. Staff U was then asked when he became aware of the critical glucose level of the patient. Staff U stated, "When the patient was roomed, I became aware of his critical lab value as I was reviewing his labs."

On 3/12/2019 at 1620 an interview occurred with staff G. Staff G was queried if a patient was waiting to be seen and had been triaged what was the protocol for monitoring. Staff G responded, "the nurse is to check at a minimum hourly on the patient." Staff G was then asked if documentation of the patient existed in the patient's medical record of the patient being monitored at a minimum of hourly while he was waiting to be seen. Staff G responded, "no."

The medical record indicates the patient was admitted as inpatient status to hospital on 3/5/2019 at 2056. The patient was discharged home on 3/8/2019 at 1431.

On 3/12/2019 at 1600 an interview was conducted with staff G, the Administrative Director of the Emergency Department. Staff G was queried what method of was utilized in order to prioritize patients needs upon presentation to the ED. Staff G stated the Emergency Severity Index (ESI) was the facility's scale of prioritizing patients. The ESI is a scale of one to five (1-5). A patient with a priority one being most immediately in need and a patient of five being considered non-urgent. Staff G was then asked with the patient being identified as a three (3) in triage what would the expectation be for the patient to be seen? Staff G stated although it would be ideal to see the patient within an hour that it is not always the case.

On 3/12/2019 at 1605, staff N, the Regional Medical Director stated there were no set policies in place for the timing of a medical screening examination of a patient. Staff N was then queried if patient #1 with a critical blood glucose had experienced a timely medical screen. Staff N did not have a response to the inquiry.

According to the Centers for Disease Control and Prevention National Center for Health Statistics reports national level data regarding ED visits (Niska, Bhuiya, & Xu, 2010). The report now categorizes arrival acuity as five levels based on how urgently patients need to be seen by the physician or healthcare provider and includes the following categories: immediate (immediately), emergent (1-14 minutes), urgent (15-60 minutes), semi-urgent (1-2 hours), and non-urgent (2-24 hours). Emergency Severity Index Implementation Handbook, 2012 Edition. Content last reviewed May 2018. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/professionals/systems/hospital/esi/esi1.html

On 3/13/2019 at 1420 a review occurred of the policy titled, "Triage Assessment in the Emergency Department," effective date 10/31/2014. According to the policy it states, "IV. Implementation: B. Documentation of ongoing care will include: 2. Serial vital signs and/or assessments, i. Patient contact and documentation will occur minimally every hour. Any update of the plan of care and any delays will be given to patients and/or their representatives., ii. Vital signs will be repeated and documented as follows: c) Level 3,4, and 5 patients: every two hours at a minimum or more frequently if clinically indicated."

On 3/13/2019 at 1425 a review occurred of the policy titled, "System Policy - Critical Tests and Critical Test Results," effective date of 2/18/2016. According to the policy, "3.2 Critical Test Results: Tests that fall outside the safe range established by the medical staff. The communication for these tests: 20 minutes for Lab to RN or licensed Caregiver and 20 minutes from RN to Physician." The policy also states under the subtitle, "Nursing-Lab and Radiology results" the following: "Upon receiving critical test results from lab and radiology diagnostic area: 1. Write down and read back all results a.) for laboratory tests, read-read back must include the critical values and test results, 2. Immediately page/contact: Appropriate Licensed Caregiver (physician, PA, etc.) responsible for care of patient. Inform appropriate licensed caregiver of critical value. Ask for a read back of values if physician does not volunteer read back....4. Document time of physician contact: in the ER.

On 3/13/2019 at 1330 a review of the facility's complaints and grievances revealed a complaint involving patient #1. According to the notes of the complaint, the family member filed the complaint at 1330 on 3/5/2019. The complaint notes state that the family member reported concerns of the patient being placed in the ED waiting room with "a blood sugar of 650 ...he is not a diabetic, nor does he take insulin ...he was triaged then placed in the waiting room for over 2-hours. He requested water, however, still has not received." The notes further stated the family member was concerned "over a DKA (diabetic ketoacidosis) crisis." A call was placed to the ED. The response documented, "the rooms are full and we have 24 patients waiting for beds upstairs. As soon as a room is available, he will be first to be taken back."

Based on document review, interview, and policy review the facility failed to advise one of five patients (#8) being transferred to another facility of the risks associated with transferring to another facility and four of five patients (#15,#16,#17,#18) being transferred to another facility of the benefits and risks associated with transferring to another facility resulting in the potential of patients not being knowledgeable of possible adverse events occurring during transfer including physical decline or death. Findings include:

On 3/12/2019 at 1630 review of patient #8's medical record revealed patient #8 was transferred from the facility's emergency department (ED) to another facility on 10/13/2018. The transfer consent sheet failed to include the "risks" associated with transfer. Staff G was interviewed during the review of the medical record. Staff G was asked if the risks associated with transfer should be listed on the transfer consent sheet. Staff G stated, "yes ...both the benefits and risks should be listed."

On 3/13/2019 at 1145 review of patient #15's medical record revealed patient #15 was transferred from the facility's ED to another facility on 11/26/2018. The medical record failed to include a transfer consent sheet. Staff G was interviewed during the review of the medical record. Staff G was asked if a transfer consent sheet should be included in the medical record. Staff G stated, "yes a transfer consent sheet should be included ...I'm surprised there is not one in the record as they are required for the transfer of a patient."

On 3/13/2019 at 1152 review of patient #16's medical record revealed patient #16 was transferred from the facility's ED to another facility on 11/8/2018. The medical record failed to include a transfer consent sheet.

On 3/13/2019 at 1302 review of patient #17's medical record revealed patient #17 was transferred from the facility's ED to another facility on 12/4/2018. The medical record failed to include a transfer consent sheet.

On 3/13/2019 at 1314 review of patient #18's medical record revealed patient #18 was transferred from the facility's ED to another facility on 9/25/2018. The medical record failed to include a transfer consent sheet.

On 3/13/2019 at 1320 Staff G was queried regarding the missing transfer consent sheets for patients #15,#16,#17, and #18. Staff G stated, "all I can think of is that the unit clerks are including the transfer consent sheets in the transfer paperwork being sent to the receiving facility.

On 3/13/2019 at 1400 a review occurred of the policy titled, "Emergency Medical Treatment and Active Labor Act (EMTALA)." According to the policy, "Transfer of Individuals", page 6, "1. the physician has signed a certification that based upon the information available at the time of transfer the medical benefits reasonable expected from treatment at another facility outweigh the increased risks to the individual, or in the case of a woman in labor, to the woman or unborn child being transferred. a) The certification (Appendix A) contains a summary of the risks and benefits and is completely filled out and signed by the individual being transferred or the person legally responsible for the individual being transferred."