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Based on document review and interview, it was determined that the hospital failed to comply with the Condition of Participation 42 CFR 482.26, Radioloic Services.

Findings include:

1. The hospital failed to ensure that during a scheduled downtime that the radiology services were uninterrupted and accessible to provide timely interpretation of emergency radiological testing. See deficiency cited at A-0529.

An immediate jeopardy (IJ) was identified on 9/28/23, due to the hospital's failure to ensure that Radiologic Services were available during a scheduled downtime, for patients that required emergency radiological services. The IJ was cited at 42 CFR 482.26 Radiologic Services, and was announced on 09/28/2023 at 3:00 PM, during a meeting with the Chief Nursing Officer, Chief Operating Officer, Attorney, Human Resource Director, Compliance Officer, Chief Medical Officer, Regional Lead, President, and Data Analyst. The IJ was not removed by the exit date of 09/28/23.

Based on document review and interview, it was determined that for 3 of 3 (Pt.#6, Pt.#7, and Pt.#8) patients that presented to the Emergency Department (ED) with chest pain and shortness of breath (SOB), and required radiological services the hospital failed to ensure that during a scheduled downtime that radiology services were uninterrupted and accessible to provide timely interpretation of emergency radiological testing. This could potentially affect all patients that may require emergency radiological services.

Finding include:

1. On 09/26/23, the hospital provided a document titled, "Cloverleaf Interface Downtime" dated 7/20/23 at 6:22 AM, and included, "Monthly Downtime for Ascension IL Applications Thursday 7/20/23 12:00 AM to Thursday 7/20/23 at 6:00 AM, scheduled network downtime is clear ... for the following ... PACS (picture archiving communication system-used to store and transmit radiological images), MRS (medical record system), access e-Forms (electric forms) ... During the 3-hour downtime, all facilities may experience a delay of Cloverleaf message deliveries affecting the transmission of orders, results ... and third-party systems ... Recommendations: During this downtime, any time sensitive laboratory or radiology results should be called to the ordering provider/clinical staff."

2. On 09/26/23, the hospital provided a Radiologist schedule for July 2023, and indicated that on 7/20/23 during off hours (3rd shift) from 10:00 PM to 6:00 AM, there were two remote Radiologists (MD #5 and MD #6) on the schedule, and one on-call Radiologist (MD #4).

3. The hospital's policy titled, "Critical Results of Tests and Diagnostic Procedures" (revised 9/23/22), was reviewed and required, "I. Identification of Critical Results. The medical and administrative leadership of ... Radiology and other departments ... are responsible for identifying diagnostic studies and test results that are considered critical ..."

4. On 09/27/23, the hospital provided an "Exclusive Professional Services Agreement" effective 02/06/23, and included, "As part of ... entered into by and between (name of Hospital network) and ... (name of Radiology group) ... Expected Turn-around times: ED (emergency department), OR (operating room), and STAT (immediately) - less than 30 minutes ... ASAP/Now Critical- less than 60 minutes ..."

5. The hospital's "Medical Staff Rules and Regulations" (approved 08/08/22), were reviewed and required, "Emergency Services ... 17. Expected response time (physically present after discussion via phone) for emergencies are as follows: Medicine 60 minutes."

6. On 09/26/23, the clinical record of Pt. #6 was reviewed. Pt. #6 arrived in the ED at 1:07 AM with a chief complaint of SOB. Pt. #6's vital signs were -blood pressure (B/P) 154/84 (high), heart rate (HR) 143 (high), respirations (R) 28 (high) and spO2 (oxygen level in the blood) 88 % (abnormal). (Normal vital signs range: B/P 90/60-120/80, HR 60-100 per minute, R 12-18 per minute, sp02 96% and above). At 1:50 AM, a Sepsis (code) was called. A physician's order (MD#8) dated 7/20/23 at 2:10 AM, included, "Priority: S (stat/immediately), Portable chest x-ray/Indication: Chest pain. At 2:12 AM, the portable chest x-ray was completed at bedside. At 2:15 AM, the critical d-dimer (diagnostic test to detect blood clot) results 5,1777 (normal range 0-622) was reported to emergency department. At 2:26 AM, the respiratory therapist was at bedside for bipap (noninvasive ventilation machine). At 3:00 AM, Pt. #6 was resting on cart and continues using bipap. MD #5 (Radiologist) called Pt #6's chest x-ray results to the emergency room on 07/20/2023 at 4:35 AM (2 hours and 23 minutes after the physician's order). Impression - primary impression - Acute exacerbation of CHF (congestive heart failure). Pt #6 was admitted to the Hospital.

7. On 09/26/23, the clinical record of Pt. #7 was reviewed. Pt. #7 arrived in the ED at 12:47 AM with complaint of chest pain. The pain was rated 9 (pain scale 0 no pain 10 worst pain). A physician's order dated 7/20/23 at 1:10 AM, included, "Portable Chest x-ray/Indication: Chest pain/Priority: S. At 1:20 AM, the chest x-ray was taken. MD #6 (Radiologist) called Pt. #7's results to the ER (emergency room) on 7/20/23 at 4:10 AM (3 hours and 5 minutes after the physicians' order). The x-ray results impression was "Mild increased interstitial markings ...it is unclear if this is related to an acute, chronic, or acute process." Pt #7 left without treatment completed a on 07/20/23 at 5:37 AM.

8. On 09/26/23, the clinical record of Pt.#8 was reviewed. Pt.#8 arrived in the ED at 1:17 AM with complaint of left sided chest pain. Pt #8 had a new pacemaker placed (unable to recall the date). A physician's order on 07/20/23 at 1:40 AM, included "Portable chest x-ray/Indication: Chest pain/Priority: S." The chest x-ray was completed at 2:01 AM. bedside. The chest x-ray results were called to the ED at 4:35 AM (2 hours and 34 minutes after the physician's order) on 7/20/2023 by MD #5. The results included, "A left-sided implantable cardiac device and its leads are stable ...No acute cardiopulmonary process. Pt #7 was discharged from the ED.

9. On 9/26/23 at 1:35 PM, an interview was conducted with a Radiologist (MD #4). MD #4 stated, "I was on-call for IR (interventional radiology). I was working remotely. At approximately 2:15 AM, I was called and asked to come to the hospital to cover because there was an issue with staff not being able to send imaging to PACS and the remote radiologists (MD #5 and MD #6) were not able to access images. I imagine that during the time before I got to the hospital the offsite Radiologists were not able to interpret imaging tests. The expected turn-around time to interpret any imaging should be within an hour. Currently the plan in case this situation occurs again, is to follow same protocol. The protocol is having someone (a radiologist) on call to come in for situations like this. The expectation is that they get here within the hour, during the time that the on-call Radiologist gets to the hospital, the ED physician can view the imaging results."

10. On 09/26/23 at 2:00 PM, an interview was conducted with the Radiologist (MD#5). MD #5 stated that during the down time, MD #5 could not visualize images remotely from approximately 1:00 AM to sometime after 3:00 AM, closer to 4:00 AM. MD #5 stated that the technologists contacted the on-call radiologist (IR/MD#4) to come to the hospital to interpret images. MD #5 stated that it is unusual for PACS to be down and not be able to see images, usually during scheduled downtime (the radiologists) can see images but we cannot report electronically, and results are given verbally by phone. MD#5 stated that when patients present to the ED that requires an x-ray, or radiological services and we cannot visualize images, there is a potential for delay in diagnosing a patient.

11. On 09/27/23 at 9:45 AM, an interview was conducted with the Administrator on-call (E #1) for 7/20/23. E#1 stated that E#1 received a call from the House Supervisor (E #7) stating that the PACS was not interfacing/working and that there was a patient that needed an MRI (magnetic resoncance imaging) read and that staff could not read images on PACS. E#1 instructed the House Supervisor to contact the on-call Radiologist for direction.

12. On 09/27/23 at 10:40 AM, an interview was conducted with a House Supervisor (E #7). E #7 stated that the ED charge nurse (E #9) called E #7 sometime after 1:00 AM, stating that the PACS reports were not being read. E #7 called the on-call radiologist (MD #4). MD #4 was contacted after several calls approximately at 2:15 AM, and agreed to come in, approximately at 3:45 AM. In the meantime, E#7 called E# 7's supervisor to escalate the situation and to contact IT (information technology) to help with PACS system. E#7 stated that by the time MD #4 arrived to the hospital parking lot, PACS was up and running and MD #4 did not have to enter the hospital.

13. On 09/27/23 at 10:55 AM, an interview was conducted with the PACS specialist (E #8). E #8 stated that E #8 was notified that PACS was down on 7/20/23. The PACS was down for approximately 2.5-3 hours, onsite and remote staff were not able to access any imaging tests, information was not able to be uploaded or sent during this time. The diagnostic testing was only visible on the actual modality (Ct-scan, MRI, X-ray, and ultrasound) during this time the physician or radiologist had to be at the site/modality to be able to view and interpret the results. This is a rare occurrence, but it has occurred in the past and can occur again.

14. On 09/27/23 at 11:07 AM, an interview was conducted with the Chief Radiologist (MD #7). MD #7 stated that the turn-around time to have emergency imaging results is 60 minutes, but they try to complete in 30 minutes. MD #7 stated that an ED physician may not be qualified to read Ct-scans or MRIs. MD#7 stated that the hospital has on-call Radiologist for off hours; however, if they are called to present on site for situations like on 7/20/23, they may not be able to get to the site in an hour.

15. On 09/27/23 at 11:45 AM, an interview was conducted with an ED Physician (MD #8). MD #8 stated, "There was an unexpected issue with the PAC system, normally we can get results faxed to us; however, the tele-radiologists could not read remotely, during this time and we were having difficulty getting CT-scan or MRI results. I do not recall if there were patients that required MRI, but there were CT scans that were pending reads. ED physicians can review some images, but we rely on the Radiologist for final read, especially for trauma or bleeds. There was a concern if a stroke patient came to the ED, we wanted to have the appropriate ability to read an acute stroke or trauma. The radiology techs reached out to IR physician (MD #4) to come in to read images on site, but I believe that (MD #4) arrived just as system was back up."

Based on document review and interview, it was determined that for 1 of 3 (Pt #1) OR (Operating Room) clinical records reviewed for handling specimens, the hospital failed to ensure that an amputated leg specimen was properly labeled, as required.

Findings include:

1. On 9/26/2023, the hospital's policy titled, "Handling of Specimens and Cultures" (dated 11/8/2022) was reviewed and indicated, "Specimens should be placed in a labeled biohazard bag for transport (patient label -specimen type and site, current date and time, hospital ID number, pertinent clinical information, as applicable)."

2. On 9/26/2023, Pt #1's clinical record (dated 8/18/2023 through 9/1/2023) was reviewed and indicated:
-MD #1's history and physical (dated 8/19/2023) noted, "Pt #1 admitted for low hemoglobin of 6.1, increased pain in left foot and infected left foot wound.

-MD #2's (Surgeon) -Operative Report dated 8/22/2023 noted, "Date of operation -8/22/2023, preoperative diagnosis - gangrene of the left foot. Postoperative Diagnosis - Gangrene of the left foot. Procedure - Below knee amputation, left leg."

-MD #3's (Pathologist) - notes dated 8/22/2023, - final diagnosis -Left below the knee amputation: gangrenous necrosis, calcified atherosclerosis, viable surgical margin. Specimen source - Left below knee amputation.

3. On 9/26/2023 at 10:30 AM, an interview was conducted with the OR Director (E #1). E #1 stated that on 8/22/2023, an EVS (environmental service) staff (E #5) threw away a red biohazard bag that contained Pt #1's amputated leg. E #1 stated that she was at work when this happened. E #1 stated that on 8/22/2023, the OR was staffed with agency nurses because the OR nurses were on strike. E #1 stated that the agency circulating OR nurse did not label the red biohazard bag that contained Pt #1's amputated leg. E #1 stated that she was in the hallway outside the OR (where Pt #1 had surgery) at the time. E #1 stated that she asked E #5 where the red biohazard bag went. E #5 stated that he threw the bag out. E #1 stated that E #5 was able to retrieve Pt #1's red biohazard bag with Pt #1's amputated leg immediately. E #1 stated that Pt #1's red biohazard bag was then labeled and brought to pathology by herself (E #1). E #1 stated that she (E #1) immediately had a huddle to re-educate staff on how to handle specimens. E #1 stated that she told the OR staff that the circulating nurse should label the specimen bag and the specimen bag is immediately transported to pathology.