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Based on reviews of clinical records, review of hospital policies and procedures, and staff interviews, it was determined the hospital failed to enforce policies and procedures that comply with the requirements of 42CFR 489.20 and 42 CFR 489.24, responsibilities of Medicare participating hospitals in emergency cases as evidenced by:

Tag A-2404 On-Call Physicians: The hospital failed to have written policies and procedures that defined the responsibilities of the on-call physician to respond by telephone, requests from the ED physician for consultation or physical examine and treatment of a patient. Patient #13 was transferred out to another acute care hospital because the on-call surgeon did not respond to calls and texts. This deficient practice poses the risk of harm to a patient when there is a delay in evaluation and/or treatment by the specilized physician on-call.

Tag A-2406 Appropriate Medical Screening Examination:
1. The Emergency Department (ED) physician did not address Patient #1's significantly abnormal lab results in the Medical Screening Examination and did not obtain and take into consideration the patient's home medications including Coumadin. The patient was discharged home and approximately 10 hours later he was transported by ambulance to a different hospital where he was admitted with diagnoses including but not limited to sepsis, renal failure, perforated gallbladder, and a critically high INR level.

2. Four of 36 randomly selected clinical records of patients who presented to the ED between the period of 7/30/2019 to 10/17/2019, were not Triaged by an RN, and/or did not receive an MSE to determine if there was an emergent medical condition. (Patients #15, #16, #17, and #23).

Tag A-2407 Stabilizing Treatment: Patient #1 was not provided necessary stabilizing treatment based on abnormal lab results obtained during the Medical Screening Examination in the Emergency Department (ED). The patient was discharged home and approximately 10 hours later he was transported by ambulance to a different hospital where he was admitted with diagnoses including but not limited to sepsis, renal failure, perforated gallbladder, and a critically high INR level.

The cumulative effect of these systematic deficient practices resulted in the hospital's inability to ensure the provision of compliance with 489.24 EMTALA requirements related to On-Call Physician responsibilities, Appropriate Medical Screening Examination, and Stabilizing Treatment to ensure health and safety for its patients.

Based on review of clinical records, review of the hospital's Medical Staff Bylaws and Rules and Regulations, and staff interview, it was determined the hospital failed to have written policies and procedures that defined the responsibilities of the on-call physician to respond by telephone, requests from the ED physician for consultation or physical examine and treatment of a patient. Patient #13 was transferred out to another acute care hospital because the on-call surgeon did not respond to calls and texts. This deficient practice poses the risk of harm to a patient when there is a delay in evaluation and/or treatment by the specilized physician on-call.

Findings include:

Documentation in the "Green Valley Hospital Medical Staff Rules and Regulations" included: "1.3 Emergency Department Call - Specialties serving on the call roster of the Emergency Room are responsible to cover their call or assure coverage by a Hospital Medical Staff member with appropriate privileges, and to notify the Medical Staff Office of any changes prior to any changes being made...1.7 Availability - Physicians with patients in the hospital must be readily accessible by pager or cell phone. Emergent call and/or critical result call to a treating physician must be answered within 20 minutes of the call; failure to respond is subject to disciplinary action by the MEC and the appropriate Department committee." There was no other documentation that specifically addressed the responsibilities of the on-call provider.

Patient #13 arrived to the ED on 9/15/2019 at 11:33 p.m. with a chief complaint of left lower abdominal pain. An MSE was performed by the ED physician at 12:31 a.m. on 9/16/2019. The ED physician documented the patient reported having nausea and "sharp/achy" abdominal pain for the prior three days which the patient rated as "9/10" at the time of evaluation. A CT scan performed at 12:40 p.m. revealed: "Acute diverticulitis in the distal descending colon. There are findings of microperforation with several small foci of gas in the adjacent mesentery...." The ED physician's documentation included: "0211 talked in person with (NP #1) and she is willing to admit if (Physician #5) is available for surgical care. Called (Physician #5) on cell phone without answer so will try per protocol. 0250 Will transfer as no general surgeon available for a perforated diverticulitis (sic). Dr. (Physician #5) called at 0211 but no answer and twice more per protocol without answering. (NP #1) texted him at 0233 with no response. A nursing note at 3:35 a.m. on 9/16/2019 included: "Called (Physician #5) for a consult for patients at 02:10 Am LVM (left voice mail) 02:22 am LVM / 0232 No answer / 0250 No answer LVM." An acute care hospital in Tucson, AZ, a distance of approximately 30 miles (Hospital #2), accepted the patient in transfer, and the patient left Santa Cruz Valley Regional Hospital at approximately 4:11 a.m. on 9/16/2019.

A review of the hospital's On-Call schedule for September 2019 revealed Physician #5 was on-call for General Surgery on 9/15 and 9/16/2019. The hospital had on-call OR staff and the capability to perform emergent surgery if necessary.

The Director of ED Services stated during an interview on 10/29/2019, that he had not been made aware of Physician #5 not responding to calls and texts for consultation on Patient #13 as documented above. The Director of Nursing reported during a telephone interview on 10/29/2019, that she was not contacted about the incident. The CEO reported during an interview on 10/29/2019, that he had not been made aware of the incident.

Based on clinical record review, review of hospital policies and procedures, and staff interview, it was determined:

1. The Emergency Department (ED) physician did not address Patient #1's significantly abnormal lab results in the Medical Screening Examination and did not obtain and take into consideration the patient's home medications including Coumadin. The patient was discharged home and approximately 10 hours later he was transported by ambulance to a different hospital where he was admitted with diagnoses including but not limited to sepsis, renal failure, perforated gallbladder, and a critically high INR level.

2. One of 36 randomly selected clinical records of patients who presented to the ED between the period of 7/30/2019 to 10/17/2019, was not Triaged by an RN, and/or did not receive an MSE to determine if there was an emergent medical condition. (Patients #15).

These deficient practices pose the risk of harm to patients that may have a medically emergent condition leaving without treatment.

Findings include:

1. The hospital's policy and procedure titled "EMTALA Guidelines for Emergency Department Services & Patient Transfers (#ED.005) included: The "Emergency Department physician will provide an appropriate medical screening examination (MSE) on all patients seeking treatment to determine if an emergency medical condition exists. All patients shall receive a medical screening exam (MSE) that includes providing all necessary testing and on-call services within the capability of the hospital to reach a diagnosis...If the medical screening exam determines that an emergency medical condition exists, treatment will be provided to stabilize the patient within the capabilities of Green Valley Hospital or arrange for transfer to another medical facility if the benefits of transfer outweigh the risks.

The hospital's policy and procedure titled, "Triage and Emergency Severity Index (ESI)," (#ED0.11) included the following: "The registered nurse will evaluate and categorize each patient upon arrival to the Emergency Department into either resuscitative, emergency, urgent, semi-urgent or routine categories. The initial evaluation shall include...Current medications, herbal supplements...."

Patient #1 was taken to the hospital's Emergency Department (ED) by emergency medical services (EMS) on 7/30/2019 at 3:40 p.m. The nurse's triage documentation included: "Found laying on floor of home by neighbor today, laceration to right lower FA (forearm) obtunded (slow to respond)." The patient's blood pressure at the time of arrival was 79/44. Another nurse's documentation at 3:51 p.m. included: "Appears in poor health" and at 5:01 p.m. the nurse documented "Pt responding to verbal stimuli s/p (status/post) administration of nacran (sic), orient x2."

The patient was evaluated by the ED physician at 6:02 p.m. who documented the patient had a right leg below-the-knee amputation, and [his/her] medical history included hypertension, myocardial infarction, two cardiac stents and "TIA Aneurysm." The physician's "Pharmacy Orders" included an order at 4:34 p.m. for naloxone (Narcan) 0.4 mg injectable. There was no documentation as to why Narcan was ordered and administered. The only other physician pharmacy orders were for intravenous fluids. The radiology orders included a CT scan of the head and a chest x-ray. The physician's documentation in the ED Provider Note included the following: "...arrived by EMS with AMS (altered mental status) after neighbor found [her/him] on the floor today unresponsive. [S/he] reports [s/he] has some abdominal pain but has no complaints...REVIEW OF SYSTEMS..."GASTROINTESTINAL: Denies nausea, vomiting, diarrhea, constipation, abdominal pain, heartburn, and bloating...NEUROLOGICAL: Denies dizziness, confusion, change in memory, gait or posture problems." PHYSICAL EXAM..."Patient was unresponsive at 16:11 (4:11 p.m.) but at 18:02 (6:02 p.m.) [s/he] was responsive and had no complaints...ED COURSE...Patient was unresponsive upon arrival but was comfortable and responsive upon reevaluation. All imaging came back normal. Patient prefers to go home and feels safe to do so." There was no documentation that an attempt was made to obtain a list of medications taken by the patient at home. The results of the laboratory tests ordered by the physician and collected at 4:23 p.m. revealed thirteen tests with values outside of the normal reference range and including the following:

-WBC (white blood cells): Patient's result: 23.3 Reference range: 4.8 to 10.8 (an elevated WBC count could indicate an active infection);
-RBC (red blood cells): Patient's result: 3.13. Reference range: 3.80 to 5.20;
-Hemoglobin: Patient's result: 9.1. Reference range: 12.6 to 17.4;
-Hematocrit: Patient's result: 27.2. Reference range: 37.0 to 51.0 (Low Hemoglobin and Hematocrit values could indicate an active or chronic bleeding);
-BUN: Patient's result: 23.6. Reference range: 7.0 to 18.0;
-Creatinine: Patient's result: 2.05. Reference range: 0.70 to 1.30; (Elevated BUN and Creatinine values could indicate renal failure);
-Total Bilirubin: Patient's result: 2.8. Reference range : 0.2 to 1.0;
-Alkaline Phosphatase: Patient's result: 1064. Reference range: 46 to 116;
-SGOT/AST: Patient's result: 171. Reference range: 15 to 37;
-SGPT/ALT- Patient's result: 165. Reference range 16 to 63 (Elevated Total Bilirubin, Alkaline Phosphatase, SGOT/AST, and SGPT/ALT could indicate liver and/or gallbladder problems)

A urine specimen was collected from the patient at 5:44 p.m. and reported at 6:05 p.m. The urinalysis included the following abnormal results:

-Clarity: Patient results: Cloudy. Reference range: Clear;
-Blood: Patient results: 2+. Reference range: Negative;
-WBC: Patient results: TNTC (too numerous to count). Reference range: None Seen;
-RBC (red blood cells): Patient results: 5-10. Reference range: None Seen;
-Bacteria: Patient results: 3+. Reference range: None Seen

The above abnormal values could indicate a urinary tract infection.

A urine culture was also performed which revealed the patient had a urinary tract infection with the organism "Escherichia coli." The lab reported this to a nurse in the ED on 8/1/2019 at 8:17 a.m., however, there was no documentation of any follow-up.

The physician's diagnosis was "AMS" (Altered Mental Status) with [his/her] current condition "Improved" and disposition "Discharged." The last nursing documentation in the clinical record at 8:24 p.m. included: "Pt requesting to go home. States [s/he's] fine and [s/he] cares for [her/himself] with no issues. Pt cleaned up and changed into clean clothes, requesting we call [her/him] a cab...."

The Chief Nursing Officer acknowledged during an interview on 9/23/2019, that the ED physician's documentation did not address patient # 1's decision making rationale to discharge the patient home without addressing the abnormal labs.

Patient #1's clinical records from another acute care hospital (Hospital #2) were obtained and reviewed. On 7/31/2019 at 6:42 a.m., EMS was again dispatched to the patient's home. Documentation in the EMS report revealed the patient was found lying on the floor and reported that [s/he] rolled out of bed during the night and was unable to get up. There were "several spots of human feces noted on floor," and the patient reported [s/he] had nausea and vomiting the prior day. The patient was transported to another acute care hospital (Hospital #2) per "Patient/Family request." A review of the ED physician's documentation from Hospital #2 revealed the patient reported [his/her] neighbor came over to check on [him/her] and found [him/her] on the floor. The neighbor was not able to assist the patient from the floor and called EMS. EMS personnel reported there was diarrhea "everywhere" including on the patient. The ED physician ordered lab tests and documented: "...a myriad of other lab tests were significantly abnormal, indicating renal failure as well as possibly choledocholithiasis as well as a coagulopathy secondary to Coumadin...." The patient's Prothrombin time (PT) was "52.2 seconds HI" and [his/her] INR (International Normalized Ratio) "5.6 CRIT (Critical)." The labwork results revealed the patient's WBC increased from 23.3 at Santa Cruz Valley Regional Hospital to a critical value at Hospital #2 of 45.6. The patient's hemoglobin had decreased from 9.1 to 8.5 and [his/her hematocrit decreased from 27.2 to 26.8. The patient was admitted and imaging studies performed which revealed a "ruptured/perforated gallbladder." The other admitting diagnoses included: "Severe sepsis due to acute cholecystitis...Acute Renal Failure...Anemia...Supratherapeutic INR." Documentation in the Discharge Summary revealed the patient could not be taken to surgery until [his/her] "medical comorbidities, renal failure, and supratherapeutic INR" were stabilized. The patient required a total of 4 units of packed red blood cells to stabilize [his/her] hemoglobin. The patient's hospital course was complicated and [s/he] was discharged to an acute rehabilitation facility on 8/20/2019.

Patient #1's ED record was reviewed on 10/21/2019 with the Santa Cruz Valley Regional Hospital ED Physician who evaluated the patient. The ED physician acknowledged there were multiple abnormal lab values which he did not address prior to discharging the patient home. The ED Physician stated the patient should have been admitted as an inpatient. The ED Physician also acknowledged there was no documentation that the patient's home medications were obtained and addressed in [his/her] MSE. The patient's home medications included Coumadin which is an anticoagulant.

In summary, Patient #1 was taken to Santa Cruz Valley Regional Hospital on 7/30/2019, after [s/he] was found on the floor in [her/his] home by a neighbor.The patient was described to be "obtunded" and unresponsive at the time of arrival but [her/his] mental status improved within two hours according to the ED physician. There was no documentation of the medications the patient took at home, however Narcan was ordered and administered approximately 1.5 hours after the patient's arrival. There was no documentation that the ED physician addressed the significantly abnormal lab results with the patient. The physician discharged the patient home approximately five hours after [her/ his] arrival with a diagnosis of Altered Mental Status. The patient's neighbor checked on the patient approximately 10 hours later and again found [her/ him] on the floor. EMS was called who transported the patient to Hospital #2 where [s/he] was diagnosed with Sepsis, critically high INR, Renal Failure, a Perforated Gallbladder, and Anemia.

2. The hospital's EMTALA policy and procedure included: "All patients presenting to Green Valley Hospital's Emergency Department seeking care...must be accepted and evaluated regardless of the patient's race, religion, national origin, age, sex, or ability to pay...The patient's medical condition shall be triaged promptly by a registered nurse. NOTE: Triage, by itself, does not constitute a medical screening exam. If after triage the patient decides not to be seen by the physician to rule out an emergency medical condition, the RN will attempt to obtain patient signature refusing emergency treatment or transfer."

Patient #15 who was elderly presented to the ED on 10/17/2019. The Face Sheet revealed the patient arrived at 12:45 p.m. with a chief complaint of abdominal pain. ED Nursing Documentation consisted of one entry that the patient "Left without being seen" at 3:09 p.m., approximately 2.5 hours later. There was no documentation that the patient was triaged promptly, as per facility policy or received an MSE during that time.

The Director of ED Services acknowledged there were opportunities for improvement.

Based on clinical record review and staff interview, it was determined Patient #1 was not provided necessary stabilizing treatment based on abnormal lab results obtained during the Medical Screening Examination in the Emergency Department (ED). The patient was discharged home and approximately 10 hours later he was transported by ambulance to a different hospital where he was admitted with diagnoses including but not limited to Sepsis, Renal Failure, Perforated Gallbladder, and a critically high INR level.

Findings include:

The hospital's policy and procedure titled, "EMTALA Guidelines for Emergency Department Services & Patient Transfers," (#ED.005) included: "If the medical screening exam determines that an emergency medical condition exists, treatment will be provided to stabilize the patient within the capabilities of Green Valley Hospital or arrange for transfer to another medical facility if the benefits of transfer outweigh the risks."

Refer to Tag A-2406. Patient #1 was taken to Santa Cruz Valley Regional Hospital on 7/30/2019 after [s/he] was found on the floor in [his/her] home by a neighbor. The patient was described to be "obtunded" and unresponsive at the time of arrival but [her/his] mental status improved within two hours according to the ED physician. There was no documentation of the medications the patient took at home, however Narcan was ordered and administered approximately 1.5 hours after the patient's arrival. There was no documentation that the ED physician addressed the significantly abnormal lab results with the patient. The physician discharged the patient home approximately five hours after [his/her] arrival with a diagnosis of Altered Mental Status. The patient's neighbor checked on the patient approximately 10 hours later and again found [him/her] on the floor. EMS was called who transported the patient to Hospital #2 where [s/he] was diagnosed with Sepsis, critically high INR, Renal Failure, a Perforated Gallbladder, and Anemia.

Physician #1 acknowledged during an interview on 10/21/2019 that the patient's abnormal lab values were not addressed in [his/her] MSE, and that the patient should have been admitted for treatment.