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501 SOUTH BUENA VISTA STREET

BURBANK, CA 91505

SAFETY POLICY AND PROCEDURES

Tag No.: A0535

Based on observation, interview and record review, the facility failed to ensure Radiology Technologist 1 (XR 1) followed the facility policy and procedure for anatomical (body) marking of a chest x-ray (CXR) for 1 of 30 sampled patients (1).

This failure resulted in XR 1 incorrectly marking Patient 1's CXR on the right side of the chest with a digital (electronic) marker indicating it was the left side, which contributed to Patient 1's wrong side chest tube placement (used to drain fluid or air from the chest).

Findings:

Patient 1's medical record was reviewed on 9/28/21.

Record review of the Registered Nurse ED (Emergency Department) Triage Notes (initial encounter and assignment of urgency), dated 6/9/20 indicated Patient 1 presented to the facility emergency room following an outpatient chest CT (computed tomography - type of x-ray) which showed the patient had a left sided pneumothorax (collapsed lung).

A review of Patient 1's orders indicated the physician's assistant (PA 1) ordered a CXR for Patient 1 on 6/9/20, shortly after the patient presented to the emergency room.

A review of Patient 1's Emergency Department Encounter Note, dated 6/9/20, indicated the patient's physician documented he reviewed the patient's CXR and the x-ray showed a right sided pneumothorax with mediastinum (organs including the heart/area between the lungs) shifted to the left. Also, per the same note, Patient 1's physician documented he inserted a chest tube into the patient's right chest and after the chest tube was inserted, he reviewed a second chest x-ray which showed a left sided pneumothorax. The note indicated the initial CXR was mislabeled by the Radiology Technician with an "L" (to indicate left) on what was the patient's right side of the chest and Patient 1 subsequently underwent a left sided chest tube placement.

During a concurrent observation and interview with XR 1, the Manager of Imaging Services and the Service Area Director of Imaging Services on 9/30/21 at 8:15 A.M., Patient 1's CXR was observed. The x-ray reflected an "L" above the right side of the patient's chest. XR 1 stated she digitally marked Patient 1's CXR right side as left because of where she observed the patient's heart location. XR 1 said the heart is located on the left side of the chest and based on where she observed the heart in the patient's x-ray, she marked it to reflect left.

The facility staff provided XR 1's written statement about the events that occurred on 6/9/20 for review. According to XR 1's written statement, XR 1 documented she shot a quick PA (posterior/anterior = back to front) CXR (patient's back was facing XR 1), was rushed and, " ...did not take the extra time to place a marker (lead marker - small marker indicating R or L for right or left and technician's initials) on the board (the board is where the patient's chest was placed against during the x-ray)." Also, per the statement, XR 1 documented she saw Patient 1's pneumothorax was so extreme it pushed the patient's heart to the right side of the chest, which was normally seen on the left side of the chest, and she placed a digital marker to what she wrongfully presumed to be the left side.

A review of the facility policy, titled, Image Identification, reviewed 8/4/21, "All radiographic (pertaining to x-ray) exams shall include accurate:... Appropriate right or left anatomic (body) marker (lead markers preferred)."

EMERGENCY SERVICES POLICIES

Tag No.: A1104

Based on observation, interview, and record review, the facility failed to ensure the policy and procedures (P&P) titled, "Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Invasive Procedures," and "Structure Standards, Emergency Room (ED)," were implemented by ED staff and physicians for one of 30 sampled patients (Patient 1), when a chest tube (tube to drain excess air or fluids from the chest) was surgically inserted into the incorrect side (right side) of Patient 1's chest for a left side pneumothorax (lung collapse caused by air leaking into the space between lungs and chest wall).

This failure led to a necessary second chest tube being surgically inserted into the correct side (left side) of Patient 1's chest, further creating the potential for bleeding, pain, infection, and serious injury or death.

Findings:

The clinical record for Patient 1 was reviewed. Patient 1's face sheet/demographics showed he was admitted to the facility on 6/09/2020.

Review of Patient 1's CT (computed tomography using special x-ray equipment to examine the chest) pulmonary angiogram, dated 6/09/2020 at 2:55 PM with results signed by MD 2 on 6/09/2020 at 3:28 PM, showed Patient 1 had a left pneumothorax. MD 2 further documented the result findings were discussed with Patient 1 and he was instructed to go to the ED.

Patient 1's initial triage nursing note upon arrival to the ED, dated 6/09/2020 at 4:11 PM, indicated, "Pt presents after having an out pt ct angio of his test [sic] (chest) which shows left sided pneumothorax."

Patient 1's provider orders show Physician Assistant 1 (PA 1) ordered a portable chest x-ray on 6/09/2020 at 4:16 PM, five minutes after ED triage.

During review of Patient 1's CXR, dated 6/09/2020 at 4:21 PM, the findings included a large left pneumothorax, and MD 2 documented "Impression - Again noted is a large left pneumothorax. There is mediastinal shift to the right with expiration."

Review of Patient 1's ED physician note, dated 6/09/2020 at 6:19 PM, MD 1 included the ED Triage Notes documented by the ED triage nurse on 6/09/2020 at 4:12 PM, "Pt presents after having an out pt ct angio of his test [sic] which shows left sided pneumothorax." MD 1's "Physical Exam" findings showed Patient 1 had a pulse of 83, respiratory rate of 20, and a blood pressure of 139/80. Patient 1's blood oxygen level was 98% on room air, interpreted and documented by MD 1 as "normal.". Under the "Chest" findings, MD 1 documented, "No increase work of breathing, no accessory muscle use, no cyanosis." Under "Cardiovascular: Heart rate and rhythm: regular rate and rhythm..."

Further, MD 1's ED physician note showed, under "ED Course and Medical Decision Making: ...(Patient 1) presented to the ED for evaluation, and he was triaged to 1605 (4:05 PM). I reviewed the nursing notes, and he was evaluated by me." In the section titled, "Medical Decision Making," Patient 1's vital signs were stable with mild increased breathing rate..."I was informed by RN of patient with tension pneumothorax in Bed...and asked to see patient immediately. I reviewed CXR: Right sided tension pneumothorax with mediastinum shifted to the left...Patient was stable at this time. Under sedation I placed right sided chest tube."

Further in MD 1's ED physician note, he documented, "After right chest tube placement I reviewed second CXR which showed LEFT sided pneumothorax. I re-examined the initial CXR. The initial CXR here was mislabeled by the radiology tech when an 'L' label on what is the patient's RIGHT side...The tension PTX (pneumothorax) was actually a LEFT sided tension PTX. I then re-sedated the patient and placed a chest tube on the left side."

Review of Patient 1's "Authorization for and Consent to Surgery Special Diagnostic or Therapeutic Procedures," dated and signed on 6/09/2020 at 5:20 PM by Patient 1, indicated consent was given for chest tube placement for right side pneumothorax.

Patient 1's "Patient Care Timeline" was reviewed. For 6/09/2020 at 5:25 PM, RN 2 documented under "Time-Out - Read Aloud with All Team Present," a right chest tube insertion procedure was started, and further indicated radiology studies were available.

Patient 1's "History and Physical" (H&P) dated 6/9/20 at 5:52 PM, by MD 3, showed Patient 1 had a history of left-sided anterior chest pain. "As part of his work-up, I ordered a CT scan of the chest...and what was found was that he had a large left-sided pneumothorax. He was then sent to the emergency department for further care and he will be admitted." In the section titled "Imaging," MD 3 documented Patient 1's CXR and CT scan of the chest showed a left-sided pneumothorax.

During a review of a written statement by XR 1, dated 6/22/2021, provided by facility administrative staff, showed XR 1 wrote, "After time had passed I was frantically called in to come shoot an x-ray of a post tube insertion. The patient [Patient 1] had not felt the expected relief and no hiss sound of air was escaping which would be expected in such a situation. The assisting nurse was reading the radiologist report of a left side pneumothorax and before me was the patient with a tube on the right side of his lungs...The Doctor questioned my prior image and I returned to my room to double check. Upon realizing my mistake I immediately called my department manager..."

During a concurrent observation and interview with Radiology Technician 1 (XR 1), on 9/30/21, at 8:20 AM, Patient 1's chest x-ray (CXR) was observed on a portable laptop computer. The x-ray showed an "L" above the right side of the patient's chest. XR 1 stated she took the CXR and when viewed for clarity prior to release, incorrectly marked Patient 1's CXR digitally (by use of a computer program). XR 1 stated she marked Patient 1's right side on the CXR as left because of where she observed the patient's heart location when she originally viewed the x-ray image.

During an interview with Patient 1's attending physician, MD 3, on 9/28/2021 at 2:20 PM, he stated that on 6/09/2020, he (MD 3) he had Patient 1 sent to the ED due to being told by Radiology Physician (MD 2) that a radiology image showed the patient had a left sided pneumothorax. He stated he arrived at the ED and observed the patient just after Patient 1 underwent a right side chest tube insertion. He stated at that time, he told MD 1 that the pneumothorax was on the left, not right. MD 3 stated x-ray results with radiologist interpretations are available to ED staff in the electronic health record, and further, that the nurse could have accessed the dictated imaging results.

During an interview with ED Physician 1 (MD 1), on 9/28/21 at 3:25 PM, he stated after he inserted a right side chest tube into Patient 1 on 6/09/2020, MD 3 came to the ED, and while MD 1 was suturing the patient's right side chest, MD 3 informed him Patient 1 had an earlier CT which showed left sided pneumothorax. He stated Patient 1 was then re-sedated and a left chest tube was inserted. MD 1 stated he did not review the triage nurse's notes indicating the reason for coming to the ED was left sided pneumothorax. MD 1 stated he did not look in the patient's clinical record for the radiology-dictated CXR results which showed a left sided pneumothorax. He stated he saw Patient 1's CXR result on a screen in the ED Physician desk area to the right, by the ED radiology room, and the x-ray was incorrectly marked by the radiology technician.

During this interview, MD 1 stated he did not re-confirm the side of the pneumothorax, either by radiologist interpretation, nor by chart review. He stated he should have been notified by radiology of a critical finding such as pneumothorax. He stated due to the radiology technologist incorrectly marking the CXR image, he made his medical decision on that image alone. During this interview, MD 1 stated someone from radiology should have called him and notified of the critical result being a pneumothorax.

During an interview with the medical staff Radiology Director (RD 1), on 9/28/21 at 4 PM, she stated a pneumothorax seen by a radiologist on images is considered a critical finding. The critical finding of left pneumothorax should have been reported to the ED staff, however that MD 2 had reported her initial finding to Patient 1's attending physician in his office, prior to the ED visit, not the ED staff or ED physician.

During an interview with the ED Manager (ED-M), on 9/29/21 at 9:30 AM, she stated during the Universal Protocol process when there is a time-out period prior to invasive procedures to ensure the correct procedure is done on the correct side of the patient, the nursing staff assisting the physician should have reviewed the CXR report in the EHR when resulted, prior to the procedure, to confirm the correct side and site of the chest tube insertion.

During an interview with Registered Nurse 2 (RN 2), on 9/29/21 at 3:15 PM, she stated she participated in the right chest tube procedure, including the time-out period prior to the procedure. She stated she does not remember reviewing Patient 1's EHR for imaging results. She stated she listened to MD 1's verbal description indicating Patient 1 had a right side pneumothorax. During this interview, RN 2 stated she had received facility education for Universal Protocol and the time-out process for invasive procedures prior to assisting with Patient 1's procedure.

The facility policy titled, "Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Invasive Procedures" with an effective date of 03/2017, showed the policy was to ensure patient safety and eliminate the risk of wrong site procedures. Further, the P&P indicated the policy requirements were applicable to all operative and other invasive procedures including procedures done in settings other than the operating room such as the bedside. The procedure section indicated verification of the correct person, procedure and site occurs and is "verified by checking the physician orders against the surgical consent, history and physical (H&P), interval note, and/or progress notes. Any discrepancies are resolved through verification by the physician operator." The P&P further indicated, in the "Time-Out" section, verified records may include radiographic images. Additionally, the P&P showed the RN/procedural personnel "may also reconfirm, as applicable, radiograph studies.

The facility policy titled, "Structured Standards, Emergency Room," with an effective date of 04/2020, indicated under "Communicating results of diagnostic tests: 2. Radiology: All x-rays are transmitted via Stentor (PACS) system to the ED for a preliminary reading by the ED Physician. A hospital contracted Radiologist is available 24 hours a day, seven days a week, 365 days a year for immediate consultation. All x-rays are overread by the radiologist for optimal patient care.