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20201 S CRAWFORD AVENUE

OLYMPIA FIELDS, IL 60461

COMPLIANCE WITH 489.24

Tag No.: A2400

Based on document review, and interview, it was determined that the hospital failed to ensure compliance with 42 CFR 489.24.

Findings include:

1. The hospital failed to conduct an appropriate medical screening as evidenced by delayed clinical intervention. See cited (A-2406).

2. The hospital failed to appropriately stabilize the patients' emergency medical condition. See cited (A-2407).

The Immediate Jeopardy (IJ) began on 3/2/2024, due to the hospital's failure to appropriately conduct a medical screening examination for 1 of 4 patients (Pt. #1) and stabilization treatment for 1 of 4 patients (Pt. #9) that presented to the Emergency Department (ED) with an ectopic pregnancy. Subsequently, this failure led to the patients deterioration and life-threatening condition. The IJ was announced on 5/3/2024 at 4:30 PM during a meeting with the hospital's the Chief Executive Officer, the Risk Manager Specialist, the Director of Quality, Director of Imaging/Oncology, the Manager of Pharmacy Services, the Director of Human Resources, the Chief Medical Officer, the Patient Experience Coordinator, the VP Mission Integration, the Chief Nursing Officer, the Manager of Educational Services, the Director of Surgery Services, the VP Marketing and Public Relations, the Director of Patient Quality Services, the VP Strategy and Business Development, the Quality Manager, the Corporate VP of Quality, the ED Medical Director, the Medical Director of Laboratory Services, the VP Administrative Services, and the Director of Services Excellence and Business Initiative. The IJ was not removed by survey exit date of 5/3/2024.

MEDICAL SCREENING EXAM

Tag No.: A2406

Based on document review, and interview, it was determined that for 1 of 4 (Pt. #1) clinical record reviewed for ectopic pregnancies, the hospital failed to conduct an appropriate medical screening, as evidenced by delayed clinical interventions. Subsequently, this led to a ruptured ectopic pregnancy (fertilized egg grows outside of uterus) and hemodynamic instability (unstable blood pressure).

Findings include:

1. The hospital's Medical Staff Bylaws (dated 04/20/2022) was reviewed and indicated, " ...13. Emergency Medical Condition (as described in the Emergency Medical Treatment and Active Labor Act ...) is a condition manifesting symptom ...which, in the absence of immediate medical attention, is likely to cause serious dysfunction ...serious jeopardy to the health of the individual ...17. Medical Screening Examination ...required to reach, with reasonable confidence, the point at which it can be determined whether an emergency medical condition does or does not exist ... ...Emergency Department within the Hospital's capabilities to determine or diagnose whether the patient has an emergency medical condition ..."

2. The hospital's policy titled, "Turnaround Time" (dated 01/10/2020) was reviewed and indicated, " ...1. STAT (immediately) orders will be drawn within 30 minutes of the order time. 2. STAT Testing performed on the site will, under normal circumstances, be reported within 60 minutes of specimen receipt in the laboratory ..."

3. The hospital's "Laboratory Reproductive Analyzer for BetaHCG (pregnancy blood test)" was reviewed and indicated, " ...total BetaHCG result approximate time to first result - 18 minutes.

4. On 4/30/2024, the clinical record of Pt. #1 was reviewed. Pt. #1 presented to the Emergency Department (ED) on 03/02/2024 at 5:29 AM, with a chief complaint of left lower quadrant pain. Pt. #1's clinical record included:

-The Emergency Room (ER) Registered Nurse (E #2) note dated 03/02/2024 at 6:49 AM, included, " ...Vital signs: pulse: 73 [normal 60 -100]; respirations: 21 [ normal 16-18]; Blood pressure (BP): 109/77 [normal 120/8 -140/90] oxygen saturation: 99%.

-The ER Resident Physician orders dated 6:50 AM, included, an HCG Quantitative (pregnancy blood test).

-The HCG quantitative report dated 03/02/2024 at 8:57 AM included, "Collected: 03/02/2024 at 6:56 AM ...Final Result: HCG Quant: 7, 471 [<5=Negative; 5-25=Indeterminate; >25 = Positive] ..." The result was made available 119 minutes after specimen collected.

-The ER Resident Physician order dated 03/02/2024 at 9:00 AM, included, "Ultrasound Pregnancy < [less then]14 weeks and pregnancy transvaginal STAT."

-At 9:54 AM, the Ultrasound Technician (E #13) took Pt. #1 via wheelchair to radiology for a transvaginal ultrasound. The exam started at 10:49 AM and ended 10:56 AM Imaging preliminary result at 11:18 AM ..."

-The US Pregnancy <14 Weeks and transvaginal report dated 03/02/2024 at 11:25 AM, included, " ...Findings: A left adnexal ectopic pregnancy is seen with active fetal heart tones at 110 BPM [beats per minute] ...gestational age 6 weeks 2 days trace free fluid in the cul-de-sac ...Radiology Resident Physician spoke with ER Physician [MD #1] at 11:15 AM ...electronically signed by Radiology Medical Director [MD #2] at 11:25 AM." From the time the STAT ultrasound was order to being read by the radiologist was 2 hours and 25 minutes.

-The ER Resident Physician order dated 03/02/2024 at 11:19 AM, included, "Consultation to OB/Gyn (Obstetrics/Gynecology)..."

-The ER Registered Nurse (E #3) note dated 03/02/2024 at 12:00 PM, included, "...[Name of On-call OB/Physician /MD #3] at bedside."

-The ER Registered Nurse (E #3) note dated 03/02/2024 from 9:12 AM to 2:32 PM, indicated that the patient was complaining of pain to the left side of the abdomen 10 out of 10 (worse pain) crying and actively vomiting. The ER notes indicated that Pt. #1 had become diaphoretic and hypotensive, at 2:19 PM BP: 79/57; and 2:32 PM BP: 72/41.

-Pt. #1 was taken to surgery at 2:32 PM. The Operating Case Tracking Event Report, included, "[Pt. #1] in Operating Room: 2:34 PM, Procedure Start: 3:09 PM ...Procedure finish: 4:32 PM ...out of room: 4:38 PM."

-Pt. #1's ER clinical record did not include the on-call OB Physician (MD #3) consultation note or assessment of Pt. #1 in ED. In addition, the clinical record did not include that MD #3 was made of change in condition: hypotensive and diaphoretic.

5. On 4/30/2024 at approximately 1:00 PM, the ER Nursing Director (E #8) was interviewed. E #8 stated that the (Pt. #1) should have been taken to the OR (operating room/surgery) within 2 hours. E #8 stated that the ultrasound showed it was ectopic pregnancy at around 11:30 AM, that is an emergent case, then the on-call team would be in the OR within an hour and 30 -minutes to set-up, so (Pt. #1) should have been in the OR table by 1:30 PM.

6. On 5/1/2024 at approximately 8:45 AM, E #3 was interviewed. E #3 stated she does not recall MD #3 conducted a pelvic exam or assessment.

7. On 5/1/2024 at approximately 10:04 AM, the On-Call OB Physician (MD #3) was interviewed. MD #3 acknowledged that an ectopic pregnancy is an emergency. MD #3 stated the ectopic pregnancy should have been in the OR in 60 minutes. MD #3 stated that MD #3's resident saw Pt. #1 and didn't know why there was no documentation. MD #3 stated after consultation they have 24 hours to create a note.

8. On 5/1/2024 at approximately 11:35 AM, the Laboratory Director II (E #11) was interviewed. E #11 stated that the beta quantitative HCG report should have been reported within an hour, when the specimen was collected at 6:56 AM, the results should have ready within 7:57 AM. E #11 stated that the analyzer only takes approximately 18 minutes for the results. E #11 stated that she (E #11) was not sure why the results were delayed.

9. On 05/01/2024 at approximately 2:45 PM, the On-call Anesthesiologist (MD #5) was interviewed. MD #5 stated Pt. #1's clinical presentation in the ER was a typical ruptured ectopic pregnancy. MD #5 stated ruptured ectopic pregnancy is highly emergent, and that he (MD #5) was not sure if they (ED Physician and staff) realized when it was ruptured.

10. On 5/02/2024 at approximately 8:52 AM, the Chief Medical Officer (MD #4) was interviewed. MD #4 stated that ectopic pregnancy is an emergency. MD #4 stated that the laboratory report for blood HCG quantitative study and the STAT ultrasound scanning could have been quicker. MD #4 stated it is not reasonable for any STAT ultrasound order to read time to be take more than 2 hours. MD #4 stated that he (MD #4) was appalled, that there was no documentation of the On-call OB consultant of any type of assessment, orders, pelvic exam, or to check if (Pt. #1) was bleeding or blood loss, and analyze what life threatening situation the (Pt. #1) was going through, to decide how soon the (Pt. #1) be taken to the surgery to stabilize her (Pt. #1) condition.

STABILIZING TREATMENT

Tag No.: A2407

Based on document review and interview, it was determined that for 1 of 4 (Pt. #9) patients clinical records reviewed with ectopic pregnancies, the hospital failed to appropriately stabilize the patient's emergency medical condition. Subsequently, this failure led to the patient's deterioration and life-threatening condition.

Findings include:

1. On 04/30/2024, the hospital's Medical Staff Bylaws (dated 04/20/2022), was reviewed and indicated, " ...13. Emergency Medical Condition (as described in the Emergency Medical Treatment and Active Labor Act) ...Emergency Department within the Hospital's capabilities to determine or diagnose whether the patient has an emergency medical condition ...emergency physician, on-call physician, obstetrician/gynecologist ...Section 4. ER Call Responsibilities: (2) The Emergency Department physician, in consultation with the on-call physician, shall determine...Section 7. Stabilizing and Treatment beyond the Capability of the Emergency Department: ...A patient is considered to be stabilized when the treating physician has determined, with reasonable clinical confidence, that the patient's emergency medical condition has been resolved ...(b) An Emergency Department physician shall be responsible for the care of all patients ...until the patient's attending physician, or an on-call physician, assumes that responsibility ...(f) Consults must be completed within 24 hours of being notified ...(h) An emergency case shall take precedence over an elective surgical case ..."

2. On 04/30/2024, the hospital's policy titled, "Scheduling Cases in OR (operating room/surgery) and Endo Procedure" (dated 10/2023) was reviewed and indicated, "...An emergent case is an immediate threat to life ...must be started without delay ...The physician must declare the case an emergency...the physician scheduling the emergency case must communicate directly ...an on-call team is available for ...emergency cases ...weekends ...the physician will notify the House Supervisor when the on-call team is needed ..."

3. On 05/01/24, the clinical record for Pt. #9 was reviewed. Pt. #9 arrived at the ED on 03/03/24 via EMS (emergency medical services) from an urgent center with a chief complaint of abdominal pain. The ED timeline included the following:

-At 3:15 PM, Triage Started: Chief Complaint: (Pt. #9) reports to emergency room from urgent center due to abdominal pain with slight nausea. Vital Signs: Temperature 98.5, Pulse 105 (reference range 60-100), Respirations 18, BP (blood pressure) 141/96 (reference range systolic BP 90-140; diastolic BP 60-90). ESI (emergency severity index) Level - 3 (urgent). Pain 0-10 at 10/worst pain ever.

-At 4:45 PM, HCG, qualitative resulted: Positive (reference range/negative) ...HCG, Quantitative value 1486 (range in pregnant women 217 to 8245 = 5-6 weeks) ..."

-At 5:26 PM, the STAT ultrasound preliminary results completed (2 hours from time of order) "... area adjacent to the right ovary may represent free fluid with internal debris versus ovarian mass ... Recommend attention and follow-up."

-At 6:27 PM, Physician Note (entered by MD #6) "Discussed with the on-call OB (MD #7/via phone), states that (MD #7) would like the quantitative HCG and CBC (complete blood count) before (OB Physician/MD #7) is able to give recommendations. (The above results were available at time of this call).

-At 7:30 PM, Pulse 88, BP 63/49.

-At 7:45 PM, Pulse 97, BP 78/41.

-At 7:53 PM, Provider Note (MD #6), "Called to the bedside (Pt. #9) had episode of hypotension (low blood pressure) and tachycardia (rapid heart beat more than 100 beats per minute) ... diaphoretic (perspiring profusely) as well. (Pt. #9) was put in Trendelenburg (head decline below the feet) and a second IV (intravenous line) was started ... two units of blood were ordered.

-At 7:59 PM, Tranexamic acid (used to control bleeding) administered.

- At 8:07 PM, Discussed (Pt. #9's) case with the OB physician (MD #7) (1 hours and 40 minutes from initial call for OB consult) ... will come to assess (Pt. #9) updated on the episode of hypotension. At 8:34 PM, (OB Physician) evaluating the patient."

-At 9:21 PM, (Pt. #9) escorted to the OR (operating room) for Ectopic Procedure (approximately 3 hours from time of ultrasound results).

Pt. #9 was taken to the OR approximately 3 hours after the time of Ultrasound and HCG results were available and indicated an ectopic pregnancy.

4. On 05/02/2024 at approximately 8:52 AM, the Chief Medical Officer (MD #4) was interviewed. MD #4 stated that once Pt. #9 ectopic pregnancy was confirmed and the consulting physician notified the arrangements should have been made to schedule for surgical procedure within an hour, before an ectopic pregnancy ruptures to prevent complications.