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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 porcedures that comply with the requirements of 42CFR 489.20 and 42 CFR 489.24, responsibilities of Medicare participating hospitals in emergency cases for Pateint #1 who came to the ED requesting emergency services and did not receive a Medical Screening Examination.

Findings include:

A-2406: Patient #1 presented to the ED on 3/17/2015, with severe edema and pain to his left lower leg. He was not monitored and did not receive a medical screening examination during his approximately seven hour stay in the waiting room of the Emergency Department. The patient left the ED without receiving a medical screening examination. The patient was taken by ambulance to another hospital approximately twelve hours later where he was admitted to the Intensive Care Unit and he died five days later.

Based on clinical record reviews, review of hospital policies and procedures, review of hospital quality activities, review of hospital security video, and staff interviews, it was determined the hospital failed to ensure that three of three patients who presented to the Emergency Department (ED) received a medical screening examination to determine if the patient had an emergency medical condition. (Patients #1, 8, and 12). Patient #1 with severe edema and pain to his left lower leg was not monitored and did not receive a medical screening examination during his approximately seven hour stay in the waiting room of the Emergency Department. The patient left the ED without receiving a medical screening examination. The patient was taken by ambulance to another hospital approximately twelve hours later where he was admitted to the Intensive Care Unit and he died five days later.

Findings include:

The hospital's policy and procedure on the subject of Emergency Medical Screen and Patient Transfers (EMTALA), Procedure #: 17.02.55, included: "The physician (or Licensed Independent Practitioner) will provide a medical screening examination, on all patients seeking treatment to determine if an emergency medical condition exists. If the medical screening exam determines that an emergency medical condition exists, treatment will be provided to stabilize the patient within the capabilities of TMC or arrange for transfer to another medical facility if the benefits of such transfer outweigh the risks...The patient's medical condition shall be triaged promptly by a registered nurse. NOTE: Triage, by itself, does not constitute a medical screening exam." The policy defined a Emergency Medical Condition as: "A medical condition manifesting itself by acute symptoms of sufficient severity, (including severe pain, psychiatric disturbance and/or symptoms of substance abuse) such that the absence of immediate medical attention could reasonably be expected to result in: Placing the health of the individual in serious jeopardy; or Serious impairment to bodily functions; or Serious dysfunction of any bodily organ or part; or Suicidal or homicidal thoughts or gestures if determined dangerous to self or others."

The hospital's policy and procedure for Nursing Assessment and Plan of Care, Procedure #: 17.02.55, included: "...Per the Arizona State Board of Nursing, Nurse Practice Act, only registered nurses can assess/reassess...May delegate components of assessment to other members of the nursing care team within their scope of practice..." The time frame for assessments and reassessments in the ED was documented to be "On arrival" and "Every 2 hours."

Patient #1 who was under the age of 32 years presented to the Emergency Department (ED) of Tucson Medical Center (TMC) on 03/17/2015 at 5:27 p.m. and was triaged by a Registered Nurse (RN) at 5:42 p.m. The RN documented in the clinical record that the patient complained of left lower extremity redness, pain, "leaking" that started the day before, and difficulty walking. The RN documented the patient's leg was red with greater than 3+ pitting edema and was hot to touch. The patient reported his pain level was "10" based on a 0 to 10 pain scale with "0" meaning no pain and "10" meaning unbearable. The patient's other vital signs recorded at that time were: Blood Pressure (BP) 144/94; Pulse (P) 84; Respirations (R)18; and Temperature (T) 98 degrees Fahrenheit. The patient's home medications included Lisinopril (for hypertension) and Prednisone (steroid). The RN assigned a triage acuity level of "3" (Urgent) based on the Emergency Severity Index 5 level triage system. The patient was returned to the waiting room of the ED and at 7 p.m. a Venous color Duplex imaging was performed in the patient's left lower leg. The findings included: "Negative for DVT (Deep Vein Thrombosis) in the left lower extremity...Limited visualization of the deep calf veins due to edema...."

There was no documentation in the ED record after 7 p.m. of the status of the patient until 2:53 a.m. on 03/18/2015, a period of almost eight hours, when the patient was called in the waiting room to be taken back into the ED and there was "no answer."

It was noted in the patient's electronic medical record that he had a hospital admission in January 2015; and ED visits in November and December 2014. The patient's past medical history included pericarditis; chronic kidney disease; and essential hypertension.

Patient #1's medical records from Hospital #2 obtained by the surveyor revealed Emergency Medical Services were called and were on scene (the patient's home) on 03/18/2015 at 11:55 a.m. The EMS narrative note included: "...yr old male has had slightly swollen legs x4 days, got markedly worse 2 days ago, went to TMC (Tucson Medical Center) yesterday and sat for 7 hrs without eval (per pt) and left. Called 911 today for same with pain in left leg mainly...appears in distress, both legs show marked edema and redness from toes to mid-thigh. Pt has had problems with edema in past but never like this (Pt states he has kidney problems called 'minimal change disease') Pt denies any SOB, unable to walk well due to pain...."

The patient arrived at the ED of Hospital #2 by EMS transport at approximately 12:40 p.m. and he was triaged at 12:42 p.m. The triage RN documented the patient had "4+ severe" edema to both feet and ankles. His vital signs at that time were: BP: 107/45; P: 112; R: 16; and T: 101.3 F. The patient reported his pain level as "10." The patient received a Medical Screening Examination and the ED physician's documentation included: "Left lower extremity, he has some skin breakdown, was (sic) a little bit of sloughing over the toes and plantar aspect of the foot. I do not see anything draining. He has 4+ edema, left lower extremity. The skin is erythematous and very tender, maximally tender, likely in the calves...The erythema goes all the way up to his groin...White count is 15.7...ABG...consistent with mild hypoxia...The patient was started on vancomycin and clindamycin. He was given IV fluid boluses, but his pressure actually dropped and he became more tachycardic...Diagnostic Impression: 1. SIRS (Systemic Inflammatory Response Syndrome) with severe sepsis. 2. Left lower extremity cellulitis, rule out necrotizing fasciitis. 3. Minimal change disease of the kidneys with bilateral pedal edema. 4. Mild hypoxia...."

The patient was admitted directly to the Intensive Care Unit and died on 03/23/2015 at 1:40 a.m. The physician's Discharge Documentation included: "The patient was initially admitted to the ICU service secondary to severe sepsis...A renal consult was called for worsening renal function. ID (Infectious Disease) was also called. Impression was cellulitis and associated worsening anasarca (extreme generalized edema)...The patient started developing hypotension on 03/21/2015. Fluid resuscitation was initiated aggressively. On 03/21/2015, as per the infectious disease note, the patient developed a toxic shock, associated toxic erythema immunosuppressed by prednisone...The patient continued to remain very critical, intubated on 03/22/2015 for worsening hypoxemic respiratory failure, likely secondary to the pulmonary edema...During the ICU course, on 03/22/2015, CRRT (Continuous Renal Replacement Therapy)...After aggressive resuscitation and aggressive CPR, the patient was pronounced dead at 1:40 a.m. on 03/23/2015...."

Information obtained during a telephone interview on 06/15/2015, with a member of Patient #1's family revealed Patient #1 made several telephone calls while he was in the waiting room to the family member. The family member reported the patient expressed increased pain in his left leg and frustration that he had not yet been taken back into the ED and seen by a doctor. The family member reported calling the ED approximately four times to let them know the Patient's pain was worse but was told each time by the staff person who answered the phone that the ED was busy, that the sicker patients needed to be seen first, and that he was being checked on.

Hospital security video of the ED triage and waiting areas on 03/16/2015, from the time the patient arrived to the time he left was obtained by the surveyor. A review of the video revealed the patient walked into the ED at approximately 5:27 p.m. on 03/16/2015, and checked in at the registration desk. He was assisted into a wheelchair and taken back to the triage area and was triaged at 5:40 p.m. He was taken back to the ED waiting room at 6 p.m. He was taken to have the venous doppler of his left lower leg at 6:34 p.m. and was returned to the waiting room at 7:03 p.m. At 7:32 p.m. the patient wheeled himself to an area around the corner from the desk and laid himself on the floor. It was noted the patient avoided bearing weight on his left leg. At 7:50 p.m. a hospital Security Officer approached the patient at which time there was a conversation and then the Security Officer assisted the patient back into the wheelchair and walked away. At 8:20 p.m. the patient again got back on the floor and laid down. The Security Officer returned at 8:23 p.m. where another conversation occurred with the patient gesturing to his left leg. The patient was assisted back into the wheelchair with the assistance of the Security Officer. The Security Officer left and returned with what appeared to be towels or blankets and placed them under the patient's left leg. At 8:38 p.m. the Security Officer returned and conversed shortly with the patient and left. The patient remained in the waiting room until 12:41 a.m. on 03/18/2015, when he was wheeled out by a person who assisted him into a private vehicle outside the entrance to the ED. There was no other staff interaction with Patient #1 after 7 p.m. other than the Security Officer while he was in the waiting room for over 5.5 hours. The patient was not evaluated by a physician nor was there a nursing reassessment of the patient after his initial triage at 5:40 p.m. on 03/17/2015, until his departure at 12:40 a.m. on 03/18/2015, a period of seven hours. It was noted that the patient made and/or received several telephone calls while in the waiting room.

The hospital had been notified of the patient's wait in the ED without being seen by a physician and his subsequent admission to another hospital and death prior to this investigation. The hospital conducted an investigation and the findings were provided to the surveyor. A Unit Clerk who worked the evening and night shifts in the ED acknowledged receiving five or six telephone calls from a family member while the patient was in the waiting room. The Unit Clerk said she had a "standard script" that she used when a patient relative calls: "We are aware that your relative is here and there are nurses who sit at triage who are able to keep an eye on him. They have assessed him and will continue to check on him while he waits...."

The hospital's documentation of the interview with Unit Clerk included: "By the fourth call the (family member) was adamant about her son being sick and unable to sit out in the lobby...(Name of Unit Clerk) left her clerk station to go check on the patient in the lobby, where she found him sitting in a wheelchair with his head resting in his hand. It was at that time that (name of Unit Clerk) shared with the Pivot RN (she couldn't remember who was sitting at the window) what was going on and how many phone calls she received by the patient's (family member)...."

An interview was requested with the Unit Clerk, however, the surveyor was told she was not available.

The Security Officer who was assigned to the Triage Desk in the ED during the evening of 03/16/2015, stated during an interview on 07/09/2015, that he approached the patient on two occasions because the patient was laying on the floor. The Security Officer said the patient told him he laid on the floor because his left leg was too painful sitting up in the wheelchair. The Security Officer said he obtained a blanket and placed it under the patient's leg and elevated the leg rest. The Security Officer said he reported the patient's pain to a nurse, however, he was not able to recall the name of the nurse.

The Clinical Nurse Lead (CNL) (Staff #6) who was on duty the evening of 03/17/2015 was interviewed on 07/14/2015. She stated she was not able to recall Patient #1 or being notified by the Unit Clerk of the numerous telephone calls of concern from the patient's family. She was asked how often people in the waiting room of the ED were reassessed by an RN and she said that Acuity 2 (emergent) patients were supposed to be reassessed by the Triage RN every two hours and the other patients were supposed to have their vital signs obtained by a PCT every two hours.

Staff #7 was a staff RN in the Triage area of the ED on the evening of 03/17/2015, and stated during an interview on 07/15/2015, that she was not able to recall Patient #1 nor was she told of telephone calls from a family member. When asked about reassessments of patients in the ED, she also stated the Acuity 2 patients were reassessed every two hours by the Triage RN and the other patients were supposed to have vital signs taken by a PCT every two hours.

The Director of the ED stated during interviews that Patient #1 was appropriately triaged when he arrived and that the nurse(s) did not feel his condition was emergent because the venous doppler revealed he had no deep vein thrombosis. She stated the triage nurse probably didn't consider the possibility of cellulitis. She acknowledged the patient's reported high level of pain in his left leg but a high level of pain would not increase his acuity level. She stated the patient should have had his vitals taken every two hours by a PCT and acknowledged that this did not happen. She added that he would not have been reassessed by an RN because he was an Acuity 3. She acknowledged that this practice did not follow the hospital's policy and procedure that stated patients in the ED would be reassessed by an RN every two hours.

The Medical Director of the ED stated during an interview on 7/16/2015, that he thought all patients in the waiting room of the ED were being reassessed by the RN Triage Nurse every two hours.

-Patient #8 presented to the ED on 03/17/2015 at 12:58 p.m., and was triaged by an RN at 1:21 p.m. The RN documented the patient reported she was pregnant, cramping, and bleeding with bright red blood and going through one pad an hour. The patient reported her last menstrual period was 02/06/2015. The RN documented: "Pt continulously (sic) moaning and rocking in wheelchair." The patient reported a pain level of "10." The patient's vital signs were: BP - 151/110; P - 105; R - 16; and T - 99.4 F. The RN did not reference the patient's abnormal vital signs in her assessment. The RN assigned the patient an acuity level of "3" (Urgent) and was sent back to the waiting room. Nursing documentation at 5:09 p.m., approximately 3.75 hours later, revealed the patient was called for an ultrasound and labwork but there was no answer.

-Patient #12 presented to the ED on 03/17/2015 at 4:49 p.m. The patient was triaged at 5:05 p.m. and the RN documented the patient reported vaginal bleeding with sharp shooting pain to her lower abdomen. The patient's vital signs were: BP - 126/76; P - 107; R - 16; and T - 99.2 F. The patient was assigned an acuity level of "3" (urgent) and sent back to the waiting room. There was no further assessment of the patient until 11:50 p.m., 6.75 hours later at which time there was no answer.

The Director of the ED provided documentation of quality improvement activities related to the ED. Documentation in the Emergency Services Report to the February 2015 Quality & Safety Council, a steady increase in their volume as well as a corresponding increase in the number of patients who were leaving without a medical screening examination starting in January 2014. A "Standard Work for TMC ED Surge Plan" was developed and implemented in 2014, however, the Director of the ED reported the surge plan had not been used in 2015 because they were "always in surge." She added that they were in the process of developing a new surge plan for the winter of 2015. The quality activities did not identify that policies and procedures were not being followed for every two hour reassessment of all patients. After the incident regarding Patient #1, the hospital developed an Action Plan that involved four phases of implementation, Phase 1 which started 06/14/2015.

In summary, Patient #1 presented to the ED on 3/27/2015 at 5:29 p.m. He had significant pain and swelling to his left lower leg and was not able to bear weight on that extremity. The patient was assigned an Acuity Level 3 (urgent). A venous doppler at 7 p.m. revealed no evidence of deep vein thrombosis and the nursing staff determined his condition was not emergent (per the Director of the ED). A family member made four or five calls to a staff member (Unit Clerk) in the ED to say the patient's pain was worse and voiced their concern. There was no documentation in the record that the concerns were communicated to a professional staff member in the ED. The patient laid on the floor of the ED two different times because of the pain which was confirmed by security video and an interview with the security officer on duty. There was no staff interaction with the patient other than the security officer after 7 p.m. Although the security video shows the patient leaving the hospital at 12:41 a.m. on 03/18/2015, hospital staff did not know he was not in the waiting room until he was called at 2:53 a.m., over nine hours after he arrived. Although the hospital's policy for reassessment of patients in the ED by an RN was every two hours, the practice at that time and currently was vital signs only for "urgent" level patients. There were no vitals signs obtained on this patient while he was in the waiting room. The patient went home and approximately 11 hours later he was taken to the ED of another hospital by EMS where he was admitted with severe sepsis and admitted to the ICU where he died five days later.