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Tag No.: A1100
Based on review of medical records, Medical Staff Rules and Regulations, medical records, and staff interviews it was determined that the facility failed to ensure that emergency services were rendered in a timely manner for two (P#1, P#9) of 12 sampled patients. Specifically, 1. P#1 had a confirmed ectopic pregnancy verified by ultrasound on 3/18/25 at 12:00 a.m. Despite diagnostic confirmation of an ectopic pregnancy, surgical intervention was not performed until 13 hours later by the 'daytime' on-call OB/GYN, MD VV. 2. P#9 was referred to the facility after a physician office visit for symptoms of pre-eclampsia and non-reassuring fetal heart tones (NRFHT) and arrived at the labor and delivery unit on 12/5/24 at 8:37 p.m. Despite advanced notification of P#9's pending arrival, the on-call OB/GYN, MD BB notified the staff at 10:32 p.m. that he was stuck in traffic and an emergent c-section was not performed until 3.5 hours after P#9's arrival to the facility.
Findings included:
Cross-refer to A-1103 as it relates to the facility's failure to ensure that services were integrated to provide emergency care.
Tag No.: A1103
Based on review of medical records, Medical Staff Rules and Regulations, policy and procedures, medical records, and staff interviews it was determined that the facility failed to ensure that all patient care services, including medical staff, were integrated to provide safe and timely care.
1. P#1 arrived at the facility's emergency department on 3/17/25 at 5:34 p.m. via ambulance with abdominal pain. An ectopic pregnancy was verified by ultrasound on 3/18/25 at 12:00 a.m. Despite diagnostic confirmation of an ectopic pregnancy; symptoms of syncope (dizziness, 'lightheaded') with passing out and abdominal pain; and positive pregnancy lab results, surgical intervention was not performed until 3/18/25 at 1:16 p.m. by the daytime on-call OB/GYN, MD VV.
2. P#9 was admitted to the facility's labor and delivery unit on 12/5/24 at 8:37 p.m. for symptoms of pre-eclampsia and non-reassuring fetal heart tones (NRFHT). At 10:36 p.m., the on-call OB/GYN, MD BB communicated to the staff that he was delayed. During the call, the nurse communicated to the on-call OB/GYN that P#9 had abnormal fetal heart tones. The MD BB requested assistance from another OB/GYN physician, MD CC. MD CC arrived at the facility and was preparing to take P#9 to the operating room for an emergent c-section when MD BB arrived. At 12:13 a.m. on 12/6/24, P#9 delivered a male infant by c-section.
Findings included:
A review of the medical record for P#1 revealed that she arrived at the facility emergency department (ED) via ambulance on 3/17/25 at 5:34 p.m. with the chief complaint of abdominal pain. A review of the 'ED Care Timeline' revealed that the results of an OB ultrasound resulted on 3/17/15 at 11:58 p.m.
A review of the 'ED Course' dated 3/18/24 at 12:00 a.m. revealed that the radiologist notified ED Nurse Practitioner (Staff) YY that P#1 had a possible ruptured left ectopic pregnancy. Continued review revealed that Staff YY attempted to reach the on-call OB/GYN (MD BB) two times unsuccessfully and care was handed off to ED Attending Physician (MD XX).
A review of the "Clinical ED Call Log" dated 3/18/25 revealed:
- At 12:01 a.m. "tried to reach MD BB "in regard to this patient; the phone went to voicemail, but the mailbox is full. Will try back in a bit."
- At 12:10 a.m. "Tried reaching MD BB again, still went to voicemail. Will try later."
- At 12:16 a.m., "spoke to a nurse in L&D, she was going to speak to the Midwife for us, NP updated."
- At 12:21 a.m. "L&D called back; they are texting the doctor for us."
- At 12:46 a.m., "tried calling MD BB again, went to voicemail but mailbox full."
- At 1:12 a.m. "Spoke to nurse in L&D, the midwife is unable to reach MD BB; was given MD AA. Will discuss with MD XX per NP suggestion because the case was handed off to him.
- At 1:19 a.m. "Called MD AA, who is in Puerto Rico, he said he will try to reach MD BB or another doctor".
- At 1:21 a.m., "MD BB called, call transferred to the ED MD ZZ."
- At 1:43 a.m., "MD BB called back, transferred the call to ED MD ZZ."
A review of the "ED Timeline" revealed that the MD BB, OB/GYN entered orders to admit to inpatient at 1:56 a.m. At 1:58 a.m., MD BB entered an order for methotrexate (used to treat ectopic pregnancy). At 2:28 a.m. a US transvaginal ultrasound was ordered by MD BB. A further review of the "ED Timeline" revealed P#1 was transferred on 3/18/25 at 6:50 a.m. to L&D and admitted at 7:11 a.m.
A review of the "History & Physical Notes" revealed a note by MD BB on 3/18/25 at 12:05 a.m., an addendum filed and electronically signed at 2:33 a.m. Impression was noted as Ectopic Pregnancy, left. P#1 was hemodynamically stable. MD BB recommended admission to the hospital for observation and repeat labs and Transvaginal Ultrasound (TVUS) at 9:00 a.m. out of an abundance of caution. Give methotrexate for treatment of ectopic pregnancy and keep patient nothing by mouth.
A review of 'ED Notes' on 3/18/25 at 3:23 a.m. revealed that the nurse called MD BB for a medication clarification for the methotrexate. Awaiting call back. At 4:51 a.m., MD BB had not return call.
A review of the "Nursing Notes" on 3/18/25:
-At 10:28 a.m. revealed that the RN called MD VV to get an update on the patient. MD VV stated that she would call back with orders.
-At 11:10 a.m. the RN spoke to MD BB concerning plan of care for the patient. MD BB stated that he would proceed with the ultrasound but was also waiting to speak with MD VV, who is the day shift on-call MD. RN spoke to MD VV about plan of care; MD VV stated she would be in the building shortly and also stated to not proceed with ultrasound at this time; patient is to be nothing by mouth and may go to operating room.
P#1 was transferred to the operating room at 1:16 p.m. on 3/18/25. A review of the procedure note revealed that P#1 underwent a laparoscopic treatment of ectopic pregnancy and partial salpingectomy (surgical excision of an ovary) on the right side. There were 2 liters of blood and clots in the abdominal and pelvic cavity.
Continued review of the medical record revealed that P#1 received a transfusion of blood products.
P#9 was admitted to the facility's labor and delivery unit on 12/5/24 at 8:37 p.m. for symptoms of pre-eclampsia and non-reassuring fetal heart tones (NRFHT). A provider "Progress Note," dated 12/05/2024 at 10:36 p.m., revealed a charge nurse called MD BB to evaluate P #9. The note revealed MD BB ordered a biophysical profile (a test to evaluate the well-being of a fetus), obstetrics (OB) umbilical arterial Doppler (a diagnostic procedure using ultrasound to assess the umbilical cord), and an OB ultrasound (a diagnostic procedure using ultrasound to assess the fetus). The note reflected MD BB was enroute to the facility but was delayed in traffic. The note indicated that Registered Nurse (RN) DD called MD BB to update the provider that the fetal heart tones were category 3 (suggested the fetus was not receiving enough oxygen; immediate medical intervention was typically required) for which MD BB planned an urgent cesarean delivery. The note indicated MD BB called MD CC who was nearby and on the way to the hospital to attend to P #9 until MD BB could arrive.
A nursing "Progress Note," dated 12/05/2024 at 10:40 p.m., revealed MD BB called the unit to inform the charge nurse that he had spoken with MD CC and that MD CC was on her way to the hospital.
P #9's "H&P [History & Physical]," dated 12/05/2024 at 11:07 p.m., revealed P #9 had non-reassuring fetal heart tones (NRFHTs) and preeclampsia (a complication of pregnancy characterized by high blood pressure) with severe features and a history of a previous c-section. The note revealed the patient disposition was for the patient to go to the operating room (OR) for an urgent repeat c-section.
A "L&D Delivery Note," dated 12/06/2024 at 12:13 a.m., revealed P #9 underwent a c-section and the infant was handed off to Neonatal Intensive Care Unit (NICU) staff. The record indicated P #9 was transferred to the recovery room in stable condition.
Patient #9's "Discharge Summary," dated 12/8/2024 at 10:38 a.m., revealed the patient was discharged on 12/08/2024 at 10:38 AM. The summary indicated the patient presented to the L&D unit due to severe preeclampsia and NRFHTs. The summary revealed Patient #9 was taken to the OR for potential life-threatening conditions and vital signs were within normal limits upon discharge home.
A facility document titled, "[Facility Name] RULES & REGULATIONS," revised 08/2024, indicated, l.l (f) Each member of the Medical Staff shall designate a member of the Medical Staff who may be called to care for his/her patients in an emergency at those times the Attending Physician is not readily available, in cases of inability to contact the Attending Physician, the following should be contacted, in order of priority listed below: (1) An alternate physician (preferably a partner, associate or designee of the Attending Physician); (2) The Chief of Staff, who may assume care for the patient or designate any appropriately trained member of the staff; (3) In the absence of the above, any appropriately trained member of the Medical Staff requested by the Department Chief of Medicine or Surgery, Medical Director, or CEO has the authority to assign a physician to provide care for the patient, go on diversion and or transfer the patient. Further review revealed for 2.6(c) Responsibility of Consulting Physician" that "[Facility Name] policy is that no physician should turn down the request for help from another [Facility Name] physician. A consult cannot be considered 'STAT' unless a physician-to-physician conversation takes place. Routine Consults are required to be seen within 24 hours. When a 'STAT' consult is placed, the consulting physician has 2 hours to see the patient. This applies to all 'STAT' consults, whether initiated from the emergency department or from the floors. Failure to comply with this will result in a review of the case by the Medical Executive Committee with potential consequences up to suspension of privileges as per the rules and regulations outline [sic] in the Medical Staff Bylaws. Failure to respond to a consult and/or within the specified timeframe will result in possible corrective action or disciplinary action pursuant to corrective action according to Article VIII, Corrective Action of the Medical Staff Bylaws.
A facility policy titled, "PROVIDER RESPONSE TIME," with an effective date of 04/22/2024, revealed, 1. A physician or licensed independent provider who is contacted by telephone, pager or other means is required to respond by telephone or physical presence at the hospital within 30 minutes. 2. Medical Staff Departments may establish more stringent requirements that are based on patient needs or regulatory or accreditation compliance. 3. Failure to respond will be documented by the hospital staff and reviewed as a quality concern consistent with hospital Performance Improvement Plan.
During a telephone interview on 04/01/2025 at 3:06 p.m., Chief of Obstetrics and Gynecology (OB/GYN) (MD) AA stated that there had been issues in the past with on call physician responses, but noted they had worked through them and the expectations were for the physicians to arrive within a 30-minute window. MD AA stated that if expectations were not met, then the case was sent to peer review. MD AA stated there had been issues with timeliness for MD BB and peer reviews were conducted, and MD BB had been spoken to. MD AA stated the hospital did not have a backup plan if the on-call physician was unavailable but noted that staff understood to call him. MD AA explained that fetal category 2 strips had decelerations with some variability, while category 3 have recurrent decelerations with no variability. ACOG practice bulletin guidelines have previously changed from 30 minutes, but now there is no time frame established for Category 3. The ultimate timeframe for Category 2 or 3 has not been established. MD AA explains that when he has a category 3, he considers it a stat/emergent situation requiring an immediate c-section; for Category 2, it's within an hour. All OB/GYNs on-call have privileges to perform C-sections. Usually for a Category 3, the response was to proceed with a C-section without delay.
There was a case where a patient went home, causing a delay (P#9); she returned several hours later because she didn't come in when instructed. If the physician arrived two or three hours later, it would be unexpected.
During an interview on 04/02/2025 at 2:25 p.m., OB/GYN Medical Director (MD) CC stated that when P #9 presented to the clinic, she (MD CC) called the hospital OB Charge Nurse and informed them that the patient was going to be there in an hour or so. MD CC stated MD BB called and asked her to come to the facility since he was stuck in traffic. MD CC stated that she completed the P#9's H&P and entered orders and recalled that MD BB arrived about 10-15 minutes after her. MD CC stated the expectation was for on-call physicians to arrive at the hospital within about 30 minutes once contacted.
A phone interview was conducted on 4/2/25 at 3:08 p.m. MD BB stated that he is an on-call OBGYN from 8:00 p.m. to 8:00 a.m. at the facility. MD BB explained that a Category 3 Fetal Heart Rate (FHR) has decelerations that result in a lack of variability and that he looks at contractions, variability, heart rate, accelerations, and decelerations and that one cannot just look at decelerations for an emergent C-section. He stated that he assesses contractions over 30 minutes, counting the average over 10 minutes-ideally, six (6) contractions average per ten (10) minutes averaged over 30 minutes. A normal fetal heart rate is between 110-159; if greater, it is called fetal tachycardia. With decelerations, you check to see if they are visually apparent and abrupt. Variability is a zigzag pattern, decelerations are abrupt decreases, and acceleration is a positive direction from the heart rate. Category 3 must have absent variability with recurrent late decelerations or recurrent variable decelerations. Category 3 per ACOG was outlined in 2006; scientific evidence doesn't support the 30-minute measure. He uses receptive measures, such as oxygen and fluids for about 30 minutes, then proceeds to the next treatment. Category 2 means indeterminate. Category 1 involves fetal heart rate tracing where there are moderate decelerations with medium variability. MD BB stated that when he is on call for the OB Unit, per bylaws and rules and regulations, there is no time frame as far as coming to the facility however, in the ED, consultants/providers have a time frame of 30 minutes to respond and 45 minutes to come to the facility. MD BB stated that he does not think there should be a time frame in the Bylaws or regulations because it's not black and white, for example, category 3. Category 3 is just delivery; whichever way is feasible.
MD BB stated that he never had a difficult time getting to the hospital other than Atlanta traffic. MD BB stated that when he is offsite, he can chart in EPIC, review labs or imaging reports and can write orders from home and or give verbal orders. MD BB stated that he might start an H&P before seeing the patient based on what the hospital has told me.
A follow up phone interview was conducted on 4/3/25, at 8:40 a.m. with MD BB. Regarding P#9, MD BB stated that when he was stuck in traffic, he remembered receiving a call on 12/5/2025 around 10:41 p.m. MD BB stated that MD CC was already at the hospital, and the fetal heart tones reverted from a category 2. At the time of delivery, the baby was taken to NICU because the baby was not term. The second reason was severe fetal growth restriction as well as limited prenatal care. MD CC was in the clinic at the time. MD and re-evaluated and reclassified as the fetal heart tones to a category 2. MD BB recalled that he called the charge nurse to inform her, and it was her responsibility to call for OR staff. There was an OB OR on-call list at the nurses' station. There was a delay on 12/5/2024 for the C-section because of staffing; the RN and Techs were not available, but he said he 'pleaded the 5th'; and do not want to answer.
During an interview on 04/03/2025 at 11:35 a.m., the Nursing Director for L&D (RN) II stated she expected on-call providers to arrive at the facility within 30 minutes to an hour. RN II explained that the expectation of on-call providers is inconsistent. RN II stated that MD BB was the only provider who did not arrive within the time limit. RN II recalled that she called MD BB regarding P#9 and that he was stuck in traffic. After delivery, the infant was transferred to another facility for a brain bleed. RN II recalled that a couple of weeks ago, P#1 came into the ED with an ectopic pregnancy; the ED tried for an hour to an hour and a half to get a hold of MD BB and he never came in to see the patient. P#1's care was transferred to the day shift OB/GYN on-call. RN II stated that when the P#1 was operated on, she had two liters of blood in her belly and had to be transfused.
A second follow up phone interview was conducted on 04/03/25 at 2:29 p.m. MD BB stated that he received a call at 10:36 p.m. on 12/5/2024 from RN DD, the charge nurse, and RN GG, another charge nurse regarding P#9. MD BB stated that while he was en route to the facility, there was a multi-vehicle crash. RN DD informed him that the P#9 had category 3 strips, and he determined that an urgent C-section was needed. MD BB stated that MD CC was in her office, which is close to the facility, so he called her, and she came and assessed the patient. MD BB stated that P#9's H&P completed by MD CC showed minimal to moderate variability and irregular contractions, categorizing them as category 2. MD BB stated that CNMs are not able to scrub in on a C-section because there would be none in the OBED Unit. RN GG was the nurse, and they didn't have a scrub tech available. When he arrived, MD CC was present, and then he had to wait for the scrub tech to show up to perform the C-section.
An interview was conducted in the facility conference room on 4/3/25 at 03:33 p.m. with Labor and Delivery Manager (RN) LL. RN LL recalled a patient with an ectopic pregnancy [P#1] was not assessed by MD BB; he had her admitted to labor and delivery but never saw her.
A phone interview was conducted on 4/4/25 at 10:51 a.m. with the Risk Manager (RM) HH who stated that the expectation of OB physicians on call for stat or emergencies is a 30-minute response time from the phone call to being present to see the patient. When the doctor cannot arrive within 30 minutes, the physician who is on call needs to reach out to a colleague to come in, rather than relying solely on the nurse or staff. Midwives should communicate with their next chain of command, and nurses should inform the Director or Manager in OB or both. From there, it should proceed to the Chief of Medicine, MD WW. Any concerns should be reported to MD WW. RM HH was not involved or aware of the situation on 12/5/24 with P#9. Regarding P#1 she believed an SBAR was completed for the ectopic pregnancy case; she was aware of it but found no VERG report. RM HH stated that the Nursing Director for OB, RN II and the OB Nursing Manager, (RN) FF met last Friday concerning a patient [P#1] who came into the ED. ED staff had attempted to call the OB/GYN on call but couldn't reach anyone. The Chief of OB/GYN, MD AA, was called. This incident just occurred and will go to peer review. The staff escalated the concern but couldn't reach the doctor. No RCA was conducted for either case because it involved physicians and will go to peer review. There was a case in July sent for peer review and is pending the physician's response.
A telephone interview was conducted on 4/4/25 at 11:45 a.m. with the Chief of Medical Staff, MD WW who stated the expectations for providers on call for OB regarding stat or emergency situations is to arrive at the facility within 30 minutes when called and to trust all medical decisions, especially in emergent cases.
A phone interview was conducted on 4/7/25 at 3:30 p.m. with MD VV. MD VV explained that she takes on-call about five days a month, generally 8:00 a.m. to 8:00 a.m. on the weekends or 8:00 a.m. to 8:00 p.m. during the week. MD VV is generally at home or in the office and is available via phone and needs to be able to get to the hospital within 20 to 30 minutes.
MD VV recalled the case with P#1 because she received a call from the facility asking her about the patient; however, she had not been given a call off report from the outgoing MD prior to the call from the nurse.MD VV stated that she was on call during the day and started at 8:00 a.m. that day. MD VV stated that she had not received a report from MD BB until about 10:54 a.m. on 3/18/25 when MD BB sent her a text saying he did not know she was covering the unit. MD VV stated that the call schedule is published, and MD BB should have known who was on call. MD VV stated that sending a text to the oncoming MD is not how she would hand-off.
MD VV reviewed P#1's record and noted that MD BB was going to repeat the ultrasound, and that MD BB had admitted her overnight for observation and had given her methotrexate. MD VV was surprised that MD BB did not take P#1 for a laparoscopy sooner rather than admitting her to observation because MD VV believed P#1 needed to go to the OR. When MD VV received the call about P#1, MD VV left her office and called the facility to see how soon she could take P#1 to the OR. MD VV then went to the facility and spoke to P#1 and P#1's mother and explained that MD VV believed that P#1 needed to go to the OR. The facility said that they would have an OR available by 1:00 p.m. In MD VV's experience, she believed that P#1 should have been taken to the OR sooner. MD VV explained that classically, with an ectopic, there are criteria that must be met to treat the condition with methotrexate, but in P#1 case, she would have taken P#1 to the OR sooner. MD VV explained that MD BB tends to like to avoid the OR and will "sit" on patients when it is not warranted. MD VV stated that MD BB seems reluctant to go to surgery.
MD VV stated that the other MDs that take call will generally do their handoff around 7:55 a.m. to 8:15 a.m. MD VV stated that she has had a couple of patients where she felt that the MD BB should have acted sooner and when this happens, MD VV will go to the unit and get the patient situated and then will talk to the administration, either MD AA, MD CC or DMS QQ about the patient and the circumstances or issues.
A phone interview was conducted on 4/7/25 at 6:30 p.m. with ED Secretary (ED-S) YY.
ED-S YY recalled the situation with P#1 and said that what she recalled was that the ED Nurse Practitioner or the ED MD ZZ asked her to call the OB/GYN on call, MD BB. ED-S YY stated that she was unable to reach MD BB and that his voicemail box was full. ED-S YY stated that she tried all the numbers she had available but still could not reach him. ED-S YY stated that she made sure that the ED NP was aware of the difficulty of reaching the on-call OB. RN DD had recommended that ED-S YY try calling MD AA. ED-S YY tried to reach MD AA but learned that he was on vacation, but he (MD AA) said that he would try to reach MD BB or someone else. ED-S YY stated that just as they hung up with MD AA, MD BB called her back. ED-S YY stated that she turned that call over to the ED MD ZZ to speak with MD BB regarding P#1.