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Based on interview, record review and policy review, the hospital's Governing Body failed to ensure that the hospital's tele-radiology (transmission of X-rays or X-ray like images through a computer monitor, while a specialized physician interprets the images at a separate location) services interpreted radiology testing results in a timely manner. The hospital's Emergency Department (ED) average monthly census over the past six months was 4,269. The hospital census was 313.

The severity and cumulative effect of this practice resulted in the hospital's non-compliance with 42 CFR 482.12 Condition of Participation: Governing Body and resulted in the hospital's failure to ensure quality health care and safety to all patients who sought emergency care.

The hospital census was 313.

Based on interview, record review and policy review, the hospital's Governing Body failed to ensure that the Chief Executive Officer (CEO) was responsible for the management of the entire hospital including accountability for the effective oversight of medical staff related to the quality of care that met the needs of one patient (#1), of one patient reviewed, when the hospital's tele-radiology (transmission of X-rays or X-ray like images through a computer monitor, while a specialized physician interprets the images at a separate location) services failed to interpret radiology testing results in a timely manner. This had the potential to affect the quality of care provided to all patients who received emergency care in the hospital.

Findings included:

Review of the hospital's document titled, "Medical Staff Bylaws," dated 11/25/19, showed the following:
- The hospital was governed by a common Board of Directors and was organized to serve as a general, acute care hospital providing patient care, education and research.
- The Health Centers Board of Directors, Administrators and its Medical Staff desire to collaborate in a well-functioning relationship reflecting clearly recognized roles responsibilities and accountabilities to enhance quality and safety of care, treatment and services provided to Health Center's Patients.
- Part of the Medical Staff functions was to monitor and evaluate care provided in and develop clinical policy for special care areas.

Review of the hospital's document titled, "Alta Vista Radiology, LLC Tele-radiology Services Agreement," dated 11/12/21, showed the following:
- Alta Vista Radiology (AVR) is in the business of providing tele-radiology (transmission of X-rays or X-ray like images through a computer monitor, while a specialized physician interprets the images at a separate location) services for medical facilities and others through a team of independent affiliated radiologists.
- Subject to the terms and conditions set forth in this agreement, AVR shall provide client with access to scheduled licensed radiologists for the purpose of providing radiology interpretations.
- Interpretations provided by AVR to client under this agreement shall be preliminary tele-radiology interpretations of computed tomography (CT, a combination of x-rays and computer to create pictures of organs, bones and other tissues, which shows more detail than a regular x-ray) study's.
- Client, or client's designated representative, may transmit or make available to AVR diagnostic radiology images for interpretation at any time during the agreed upon on-call period.
- AVR's radiologists shall use their best efforts to issue, via facsimile, telephone call or other agreed upon method of communication, a preliminary report within 30 minutes of receipt of client's radiology images.

Review of Patient #1's medical record dated 04/19/23, showed the following:
- He was a 41-year-old male who presented to the Emergency Department (ED) via Emergency Medical Services (EMS, emergency response personnel, such as paramedics, first responders, etc.) at 2:10 AM, after being involved in a motor vehicle crash (MVC).
- The chief complaint listed was MVC on the highway with airbag deployment, Patient #1 was unrestrained, and found in the passenger seat. His pupils were pinpoint and he arrived in a cervical collar (c-collar, a device used to support the neck and spine and limit head movement after an injury).
- At 2:20 AM, Staff O, Physician, ordered vital signs to be obtained every 30 minutes, cardiac monitoring, a blood alcohol level, a complete blood count (CBC, a blood test performed to determine overall health including inflammation or infection), comprehensive metabolic panel (CMP, a blood test performed to determine a variety of diseases and conditions), creatinine kinase plasma (CPK or CK, an enzyme found in the brain, skeletal muscles and the hearts; in a CPK test an elevated level could be associated with damage to those areas, normal range was 30 - 200), lipase (a blood test that measures the amount of lipase [an enzyme that is made by your pancreas], normal range was 8 - 78), troponin (a type of blood test that measures whether or not a person is experiencing a heart attack, normal is less than 0.01), urine drug screen, blood type and screen panel, an electrocardiogram (EKG, test that records the electrical signal from the heart to check for different heart conditions), and a computed tomography (CT, a combination of x-rays and a computer to create picture of organs, bones, and other tissues, which shows more detail than a regular x-ray) of the head, cervical spine, thoracic spine, chest, abdomen and pelvis.
- CT scans were documented as completed at 3:52 AM.
- At 6:40 AM, Staff O, Physician, documented that she was contacted by the Radiologist to notify her of the findings of Patient #1's CT scan, which showed aortic disruptions (a transection that is a near-complete tear through all the layers of the aorta due to trauma such as that sustained in a MVC) and mediastinal hemorrhage (excessive bleeding in the central compartment of the chest cavity that housed many vital structures including the heart). Patient #1 remained hemodynamically stable, trauma surgery was paged.
- At 6:44 AM, Staff O discussed the case with the trauma surgeon, who requested she contact vascular surgery.
- At 6:50 AM, Staff O rechecked the patient and found him less responsive, moaning in response to her questions, but no longer opening his eyes. He was sweaty and she was unable to obtain a blood pressure. She called for help and IV fluids were hung. Patient #1 was then upgraded to a level one trauma.
- At 7:05 AM the trauma team was at the bedside performing cardiopulmonary resuscitation (CPR, emergency life-saving procedure performed when a person's breathing or heartbeat has stopped).
- At 7:53 AM, time of death was called for Patient #1.

During a telephone interview on 09/25/23 at 9:45 AM, Staff J, ED Director, stated that AVR were the contracted Radiologists that read CT scans for the hospital overnight. It was a long period of time from Patient #1's arrival to the ED and the time the CT scans were read by AVR.

During a telephone interview on 09/26/23 at 1:00 PM, Staff W, Radiologist for AVR, stated that he read the CT scans for Patient #1. The patient had a transection of the aorta and was bleeding, he found it right away on the scans. He called the ED provider as soon as he noticed it, and was surprised when the ED provider told him the patient was stable. He read scans that appeared at the top of the list. Patient #1's CT scans probably sat on the list waiting to be read for quite some time. CT scans for trauma cases should be resulted within an hour at most. If CT technologists or physicians did not call and specifically ask for a CT to be read, then he would just read them as they were listed.

Based on interview, record review and policy review, the hospital failed to ensure that interpreted radiology results were reported in a timely manner for one patient (#1) of one patient reviewed. This failure had the potential to lead to a delay in diagnosis and treatment of all Emergency Department (ED) patients that presented with an Emergency Medical Condition (EMC) with the potential for negative outcomes. Patient #1 expired before his EMC was properly diagnosed and treated. The hospital's Emergency Department (ED) average monthly census over the past six months was 4,269. The hospital census was 313.

Record review of Patient #1 showed he was a 41-year-old male who presented to the ED at 2:10 AM, via Emergency Medical Services (EMS, emergency response personnel, such as paramedics, first responders, etc.) following a motor vehicle collision (MVC). He was considered a trauma level two after his assessment. He had to be sedated and restrained during his ED visit prior to going for computerized tomography (CT, a combination of x-rays and computer to create pictures of organs, bones and other tissues, which shows more detail than a regular x-ray) scans at 3:00 AM. CT imaging began at 3:13 AM and finished at 3:52 AM. A CT of the chest, abdomen and pelvis were submitted and ready to be interpreted to Alta Vista Radiology (AVR, LLC Tele-Radiology Services) at 5:02 AM, where they sat waiting to be read until approximately 6:35 AM. At 6:40 AM, the Radiologist with AVR made a phone call to the ED Physician to report that Patient #1 had a serious aortic injury. The ED Physician then paged on call trauma surgeons and a vascular surgeon and upgraded the patient to a trauma level one. The ED Physician then checked on Patient #1 and was unable to get a blood pressure and the patient was less responsive. The vascular surgeon reviewed the CT scans and noted that Patient #1's injury was easily repairable with a graft and went to the hospital to perform the procedure. Upon arrival to the hospital Patient #1 was receiving Cardiopulmonary Resuscitation (CPR, emergency life-saving procedure performed when a person's breathing or heartbeat has stopped). Patient #1 expired at 7:52 AM.

Based on interview, record review and policy review, the hospital failed to ensure that interpreted radiology results were reported in a timely manner for one patient (#1) of one patient reviewed. This failure had the potential to lead to a delay in diagnosis and treatment of an emergency medical condition (EMC) and poor patient outcomes.

Findings included:

Review of the hospital's document titled, "Alta Vista Radiology, LLC Tele-radiology Services Agreement," dated 11/12/21, showed the following:
- Alta Vista Radiology (AVR) is in the business of providing tele-radiology (transmission of X-rays or X-ray like images through a computer monitor, while a specialized physician interprets the images at a separate location) services for medical facilities and others through a team of independent affiliated radiologists.
- Subject to the terms and conditions set forth in this agreement, AVR shall provide client with access to scheduled licensed radiologists for the purpose of providing radiology interpretations.
- Interpretations provided by AVR to client under this agreement shall be preliminary tele-radiology interpretations of computed tomography (CT, a combination of x-rays and computer to create pictures of organs, bones and other tissues, which shows more detail than a regular x-ray) study's.
- Client, or client's designated representative, may transmit or make available to AVR diagnostic radiology images for interpretation at any time during the agreed upon on-call period.
- AVR's radiologists shall use their best efforts to issue, via facsimile, telephone call or other agreed upon method of communication, a preliminary report within 30 minutes of receipt of client's radiology images.

Review of the hospital's document titled, "Who's on call," dated 04/19/23, showed that there was a Vascular Surgeon, Trauma Surgeon, back up Trauma Surgeon, and a Cardiothoracic Surgeon on call and available to ED staff.

Review of the hospital's undated document titled, "Timeline for E13311522 (J.M.)," showed the following timeline of events that occurred during Patient #1's ED visit on 04/19/23:
- Per interview with ED provider, another critical patient came into the ED at or about the same time with significant respiratory distress. The other patient was sent to CT scanner room one before Patient #1, as he was more unstable. CT room one has automatic reconstruction capabilities versus CT room two which requires manual reconstruction of images.
- Patient #1 had head, cervical spine (c-spine, neck region), chest, abdomen and pelvis CT scans ordered, which included reconstruction of thoracic (the middle portion of the spine) and lumbar spine (lower back) to reduce radiation exposure time to the patient.
- All radiology orders were placed at 2:20 AM.
- Patient #1 was uncooperative and intoxicated.
- Patient #1 had to be sedated with Ketamine (short acting anesthetic) prior to his CT which, coupled with the physician assessment accounted for time from arrival to the ED until transport to CT.
- Ketamine was administered to the patient at 3:00 AM and the patient was taken to CT room two.
- All CT exams began at 3:13 AM.
- All CT exams ended at 3:52 AM.
- A request for AVR review of the head and cervical spine were submitted at 4:11 AM, with both tests being resulted at 5:13 AM.
- A request for AVR review of the chest, abdomen and pelvis were submitted at 5:02 AM.
- Due to CT room two requiring manual reconstruction of images, thoracic and lumbar spine manual reconstruction had to be completed prior to submission.
- Technologist documentation stated the patient was uncooperative and moving around on the CT table.
- AVR called a critical value report to the ED provider, five minutes after opening the exam at 6:40 AM.

Review of Patient #1's medical record dated 04/19/23 showed the following:
- He was a 41-year-old male who presented to the ED via Emergency Medical Services (EMS, emergency response personnel, such as paramedics, first responders, etc.) at 2:10 AM, after being involved in a motor vehicle crash (MVC).
- The chief complaint listed was MVC on the highway with airbag deployment, Patient #1 was unrestrained, and found in the passenger seat. His pupils were pinpoint and he arrived in a cervical collar (c-collar, a device used to support the neck and spine and limit head movement after an injury).
- At 2:18 AM, Staff O, Physician, documented that Patient #1 had no known past medical history, was significantly intoxicated, could not remember the event, and denied having been in a MVC. EMS reported to the physician that the patient was found in the passenger floorboard of the car. Initially he was not responsive and had pinpoint pupils, without intervention the patient came around and was awake and alert upon his arrival to the ED. He had no complaints at the time of the assessment. He was considered a level two trauma. Patient #1 was in no acute distress, had only a horizontal laceration to the upper left eyelid, and was oriented to himself only.
- At 2:20 AM, Staff O, Physician, ordered vital signs to be obtained every 30 minutes, cardiac monitoring, a blood alcohol level, a complete blood count (CBC, a blood test performed to determine overall health including inflammation or infection), comprehensive metabolic panel (CMP, a blood test performed to determine a variety of diseases and conditions), creatinine kinase plasma (CPK or CK, an enzyme found in the brain, skeletal muscles and the hearts; in a CPK test an elevated level could be associated with damage to those areas, normal range was 30 - 200), lipase (a blood test that measures the amount of lipase [an enzyme that is made by your pancreas], normal range was 8 - 78), troponin (a type of blood test that measures whether or not a person is experiencing a heart attack, normal is less than 0.01), urine drug screen, blood type and screen panel, an electrocardiogram (EKG, test that records the electrical signal from the heart to check for different heart conditions), and a CT of the head, cervical spine, thoracic spine, chest, abdomen and pelvis.
- Vital signs upon arrival were blood pressure (BP, a measurement of the force of blood pushing against the walls of the arteries at two different times during a heart-beat, normal is approximately 90/60 to 120/80) 132/52, pulse rate (the number of heart-beats per minute, normal range for adults is 60 to 110 beats per minute) of 110, temperature 97.3, respiratory rate (RR, the number of breaths per minute, normal range for adults at rest is 12 to 20) of 28 and oxygen saturation (measure of how much oxygen is in blood) of 94%. Vital signs were recorded by nursing staff approximately every 30 minutes throughout the ED visit until 6:28 AM.
- Blood work was obtained at 2:21 AM, and showed a blood alcohol level of 360.6 (normal range was less than 10), a blood glucose level of 197 (normal range was 70-105), a low carbon dioxide (CO2, a gas produced by exhaling, normal range was 23 - 31) level of 17, an elevated creatinine (a blood test that shows how the kidney is functioning, normal range was 0.72 - 1.25) of 1.30, an elevated CK of 315 and an elevated lipase of 167.
- An EKG performed at 2:23 AM, showed sinus tachycardia (an increased heart rate that exceeds 100 beats per minute, possible left atrial enlargement and was a borderline EKG.
- At 3:00 AM, Patient #1 was given Ketamine prior to having his CT scans.
- CT scans were documented as completed at 3:52 AM.
- Nursing staff documented a urine sample was collected at 4:48 AM, and was positive for marijuana.
- Patient #1 was administered topical pain medication at 4:48 AM.
- Fentanyl (a medication used to treat severe pain, and is a high risk drug for theft and personal use) was administered intravenously (IV, in the vein) at 5:53 AM, but there was no documentation of a pain assessment prior to or after the medication was given.
- Anti-nausea medications were administered IV at 5:55 AM.
- A second EKG was performed at 6:24 AM, and showed an increased heart rate of 122.
- Vital signs recorded at 6:28 AM, showed a BP of 118/88, pulse rate of 97, RR of 29 and oxygen saturation of 91%.
- At 6:40 AM, Staff O, Physician, documented that she was contacted by the Radiologist to notify her of the findings of Patient #1's CT scan, which showed aortic disruptions (a transection that is a near-complete tear through all the layers of the aorta due to trauma such as that sustained in a MVC) and mediastinal hemorrhage (excessive bleeding in the central compartment of the chest cavity that housed many vital structures including the heart). Patient #1 remained hemodynamically stable, trauma surgery was paged.
- At 6:44 AM, Staff O discussed the case with the trauma surgeon, who requested she contact vascular surgery.
- At 6:50 AM, Staff O rechecked the patient and found him less responsive, moaning in response to her questions, but no longer opening his eyes. He was sweaty and she was unable to obtain a blood pressure. She called for help and IV fluids were hung. Patient #1 was then upgraded to a level one trauma.
- Staff T, Physician, documented that at 7:05 AM, he received a page and was speaking to the ED attending physician within seconds, where it was reported to him that the trauma team was at the bedside performing cardiopulmonary resuscitation (CPR, emergency life-saving procedure performed when a person's breathing or heartbeat has stopped). He logged into his computer, reviewed the imaging and identified that the damage was repairable in the operating room (OR), and explained his findings to the ED/trauma team. He felt that the repair could be performed in an expeditious fashion so he contacted the representative for the product required, and drove to the hospital. He was at the bedside as quickly as possible and remained at the bedside with the trauma team until Patient #1's time of death.
- At 7:53 AM, time of death was called for Patient #1.

During a telephone interview on 09/21/23 at 2:00 PM, Staff O, Physician, stated that when Patient #1 arrived to the ED he was quite drunk and uncooperative. She had to sedate the patient prior to being able to perform the CT scans. At the same time Patient #1 arrived to the ED another critical patient, who was sicker, went to CT before Patient #1. She did have the ability to look at CT scans as soon as they were obtained. She was not that concerned with Patient #1 though, as he was hemodynamically stable, and his vital signs were stable. He had no complaints. She relied on the Radiologist to call her with results of the CT scans. When the Radiologist did call her his first words were, "is this man already in the OR". At that time she upgraded him to a trauma one. About 10 minutes after the phone call from the Radiologist she went in to check on Patient #1, and he was starting to decompensate. That was the first sign all night that he was not ok. The CT technologist did not call her to report anything going on when the scans were obtained, usually they would give her a call if they noted something that she needed to see. Typically it would take at least one hour and thirty minutes for a trauma scan to be read by the Radiologist. The ED was very busy that night with several critical patients. She had no indication that Patient #1 was as critical as he was. She did not think to look at his CT scans herself as she relied on the Radiologist from AVR, and the CT technologists to let her know if something was wrong. Since she never received a phone call she thought there was nothing notable on the scans.

During a telephone interview on 09/21/23 at 5:00 PM, Staff T, Physician, stated that what happened with Patient #1 was completely preventable. The type of injury and the location was fixable and repairable, the procedure he needed could have been done percutaneously (minimally invasive procedure that pushes through the skin as opposed to cutting the skin open) in about 45 minutes. Under different circumstances it was a procedure that could have been done in his office. Patient #1's death could have been prevented if it was identified sooner. He was paged by the ED Physician and he reviewed the CT images. He headed to the ED as soon as he identified the injury. When he got there ED staff had already begun CPR. He stayed in the room until they called the case. He did not think there were any changes made or processes put into place to keep something like this from happening again. If a CT scan was labeled as Trauma, or STAT (immediately), then it should be reviewed in 15 to 20 minutes. The location of the hospital made it highly likely they would receive a trauma patient similar to Patient #1.

During a telephone interview on 09/25/23 at 9:45 AM, Staff J, ED Director, stated that AVR were the contracted Radiologists that read CT scans for the hospital overnight. It was a long period of time from Patient #1's arrival to the ED and the time the CT scans were read by AVR. He felt that an incident similar to this one could happen again.

During a telephone interview on 09/26/23 at 1:00 PM, Staff W, Radiologist for AVR, stated that he read the CT scans for Patient #1. The patient had a transection of the aorta and was bleeding, he found it right away on the scans. He called the ED provider as soon as he noticed it, and was surprised when the ED provider told him the patient was stable. He read scans that appeared at the top of the list. Patient #1's CT scans probably sat on the list waiting to be read for quite some time. CT scans for trauma cases should be resulted within an hour at most. If CT technologists or physicians did not call and specifically ask for a CT to be read, then he would just read them as they were listed.

During a telephone interview on 09/25/23 at 7:30 AM, Staff U, Registered Nurse (RN), stated that when Patient #1 arrived to the ED on 04/19/23, he was very intoxicated. He was alert, but did not know what was going on. Patient #1 kept stating, "I wasn't in a car, I am fine." He kept trying to leave the ED. Patient #1 was hemodynamically stable. There was another trauma in the room next to Patient #1, so a different nurse took Patient #1 to have his CT scans. Patient #1 had to be medicated to go to CT. After he had his CT scans he was pretty calm and did not try to leave the ED after that. At night CT scans were read by AVR. After CT images were completed they were sent to AVR and put on a list to be read. The scans got read when they got read, no specific timeline for them. Some CT technologists would call the ED to report anything alarming they saw while doing the scans, but some did not. Patient #1 was fine and then suddenly he was not. CT technologists were able to recognize if something didn't look right on a scan, a lot of times that was how they caught problems quickly overnight. The ED relied heavily on the CT technologists to inform them of significant issues with patients.

During an interview on 09/26/23 at 4:23 PM, Staff V, CT Technologist, stated that Patient #1 was very belligerent, non-compliant, kept moving during his CT imaging which resulted in not very good scans. He almost fell off the table once, and then it took her and a nurse about 45 minutes to get him off of the table and back to the ED after she was finished with the imaging. She had to reconstruct the CT images to be sent to AVR, and they were not very good due to the patient not cooperating. CT technologists were not expected to call if they noted something while performing the imaging. But if she had noticed anything wrong she would have called. She was more focused on getting the images and keeping the patient safe and from falling off of the table. For a trauma patient, the time from completion of imaging to the read should be no more than one hour.

During an interview on 09/21/23 at 3:00 PM, Staff Q, Director of Imaging, stated that Patient Safety contacted her to look into the incident with Patient #1. She looked into the delay in AVR reading the scans, but found that the Radiologist actually called the ED Physician within five minutes of opening the scans. Trauma patients took time, and images had to be reformatted. When she looked into the timeline she found that it was 34 minutes from the time the CT scans were available to when they were ordered for AVR to read. AVR only read CT scans for the hospital at night from 8:00 PM until 7:00 AM. Since there were 1,316 images that had to be scanned, reformatted and sent to AVR that just took time. The CT scans for a trauma protocol typically took 30 to 45 minutes to complete. Staffing issues were another factor contributing to the delay.

During a telephone interview on 09/21/23 at 2:30 PM, Staff P, Patient Safety Specialist, stated that she was alerted on 04/19/23 about Patient #1's ED visit. On 04/19/23 an investigation began, what happened, what was the delay, how did this happen. At night there was not a Radiologist on-site at the hospital, so all CT scans were sent to AVR to be read. The hospital had two CT scanners, one that automatically uploaded the images and one that had to be manually uploaded. Patient #1 was in the CT scanner that had to be manually uploaded to the system to be sent to AVR for interpretation. Initially the team thought that the delay was getting the patient to the CT scanner as he was combative and had to be restrained. CT technologists were not credentialed to interpret CT scans, or to make a diagnosis. It was not hospital policy for them to call a physician if they saw something in question during a CT scan.