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17101 DALLAS PARKWAY

ADDISON, TX 75001

COMPLIANCE WITH 489.24

Tag No.: A2400

Based on interview and record review, the hospital (Hospital A) failed to abide by the provider's agreement that required a hospital to comply with §42 CFR 489.24, Special responsibilities of Medicare hospitals in emergency cases. The hospital was not in compliance with the EMTALA (Emergency Medical Treatment and Labor Act) requirements, citing 2 of 2 patients (Patient #1 and Patient #2) that presented in the emergency department (ED) on 07/22/17 and 07/23/17 respectively.

Cross Refer to Tags 2407 and 2409

STABILIZING TREATMENT

Tag No.: A2407

Based on interview and record review, the hospital (Hospital A) did not provide appropriate stabilizing treatment to 2 of 2 patients (Patient #1 and #2) who presented in the emergency department (ED) on 07/22/17 and 07/23/17 respectively.

Findings included:

1. Patient #1 presented in Hospital A's ED on 07/22/17 at 11:07 PM. During triage Personnel #9 indicated the chief complaint was "left lower abdominal pain with dark brown vaginal discharge...onset...3 hours ago."

On 07/22/17 at 11:20 PM Physician #7 saw the patient. Physician #7 indicated "Chief Complaint pelvic pain/ pelvic pressure...3 hours ago...Timing: still present...pelvic pain was noted on the left side...weak...irregular...vaginal discharge (brownish-thick)...first pregnancy occurred in right uterus-full term..." Physician #7 noted the patient had a "didelphys" condition (rare condition of having 2 uterus). Blood work and obstetric (OB) sonogram were ordered. Physician #7 planned to transfer the patient and at 1:55 AM [07/23/17] progress notes reflected Patient #1 was accepted at Hospital C.

On 07/23/17 at 3:30 AM Physician #7 indicated the "patient experienced abdominal contractions...in her 2nd trimester of pregnancy...had a precipitate vaginal delivery of a preterm baby."

On 07/23/17 at 4:39 AM Personnel #9 noted the Patient #1 "...did not deliver placenta, left in care of EMS ground."

On 07/23/17 at 5:00 AM Physician #7 wrote "Patient #1 condition: after baby delivered, the placenta still retaining..."

On 07/23/17 at 5:11 AM Ambulance 1 transferred Patient #1 to Hospital B. The original plan was for Patient #1 to be transferred to Hospital C.

Patient #1 remained in the ambulance bay of Hospital A after a precipitous delivery from 3:30 AM until 5:11 AM (time Ambulance 1 left Hospital A), a total of 100 minutes after the delivery. During this time Patient #1 was at risk for severe infection or life-threatening blood loss since the placenta was not delivered. Physician #7 did not continually assess the patient for infection and/or bleeding.

Hospital B Patient #1's medical record reflected "Patient #1 Genital: Ext: covered with blood, RN states large amt of blood on pad beneath buttocks on arrival; 8 inches of umbilical cord with clamp present hanging from vagina...Vag: placenta partially in vagina by my exam, large amt of dark clot expelled from vagina on exam...Plan of Care: IVF at 150 milliliter(s)/hr STAT admission labs including UDS and Type and Cross for 2 units Close watch..." Subsequently Patient #1 received 2nd units of "PRBC." Per OB Notes dated 07/23/17 "...Placenta delivered spontaneously..." The OB's diagnosis was "Anemia due to acute blood loss Delivered at outside facility. Brought in by EMS Neonatal demise."

This excerpt was taken from the Mayo Clinic website on 08/22/17 at 11:26 AM at http://www.mayoclinic.org/healthy-lifestyle/pregnancy-week-by-week/in-depth/placenta/art-20044425 "Retained placenta. If the placenta isn't delivered within 30 to 60 minutes after childbirth, it's known as retained placenta...Left untreated, a retained placenta can cause severe infection or life-threatening blood loss in the mother."



2. Patient #2 was precipitously delivered on 07/23/17 at 3:30 AM. A Code Blue was activated at 3:30 AM due to "respiratory arrest." Simultaneously, Ambulance 1 staff (Personnel #1A and 2A) entered Patient #2's room [the same room as Patient #1]. Patient #2's vital signs and condition per Ambulance 1 record were as follows: at 3:30 AM, the baby was "unresponsive...pulse 50, respiration 10, SpO2 72 room air, and BG (blood glucose) 92." At 3:40 AM the temperature was 98.6. From 3:40 AM to 4:35 AM the pulses ranged from 150 to 0, respirations ranged from 52 to absent, and SpO2 from 95 to absent.

According to Hospital A's code blue record Patient #2's vital signs were as follows: "at 3:30 AM pulse (P) 142, respiration (R) 32, and O2 Sat 97-bag valve mask, CPR." From 3:35 AM to 4:39 AM pulses ranged from 71 to 149, respirations ranged from 32 to 50, O2 sats ranged from 59 to 98. The last recorded vital signs at 4:39 AM were as follows: P 116 and O2 sat 90 with bagging and CPR.

The Code Blue was activated at 3:30 AM on 07/23/17. At 4:10 AM, Patient #2's O2 sat had decreased to 79 and heart rate 142. From 4:11 AM to 4:39 AM, the baby's heart rate ranged from 48 to 122 and O2 sats ranged from 59 to 90.

On 07/23/17 at 4:39 AM a nurse noted Patient #2 was okay to transfer...if HR (heart rate) was 100 and above, SpO2 90 and above, neonate packaged and loaded up on ambulance, but remained critical, CPR progressed on transfer...CODE OUTCOME: Remain critical at transfer."

At 4:40 AM [in the ambulance parked closed to the ED entrance], the baby was "unresponsive, pulse 0, respiration A." Physician #7 was asked to come out to the ambulance. Physician #7 came out. Physician #7 did not assess, evaluate, or examined Patient #1. Physician #7 did not give instructions to manage and/or treat Patient #2's care.

Patient #2 was pronounced dead at 4:57 AM on 07/23/17 by Hospital B's Physician B1 via phone while in the ambulance on the hospital's premises. Hospital A's Physician #7 refused to come out to assess and pronounce Patient #2.

Both Patient #1 and Patient #2 were subsequently transferred to Hospital B at 5:11 AM on 07/23/17.

During an interview on 08/14/17 at 2:30 PM with Physician #7 (Hospital A) via telephone call she stated the baby had pulse when leaving the ED and felt the baby was stable at that time. She confirmed she went out to the ambulance, could not recall if she gave orders, and did not pronounce the baby dead. Physician #7 stated "I didn't feel comfortable pronouncing the baby."


During an interview on 08/15/17 at 1:38 PM with Ambulance 2D (certified neonatal nurse-Ambulance B) via telephone she stated that they arrived at Hospital A "very quickly, and the team proceeded to the ED door and was told to go to an ambulance in the parking lot. The baby was on top of the mom in the ambulance. After getting into the ambulance, 3 female hospital staff members attempted to close the ambulance door. She prevented them from closing the doors and told them she wasn't going anywhere until the baby was stable. She told them she needed to bring the baby back into the ED. The 3 staff members shook their heads no and said no. They had on dark scrubs. She stated that the baby didn't have a heart rate. She asked a paramedic to go and get the ER doctor because they needed to code the baby. The ED physician came and stood outside of the ambulance. The team was able to remove the oral airway and intubate the baby. They worked on the baby from around 4:20 AM to approximately 4:50 AM. The baby never had a heart rate. There was no supplies in the ambulance. There was only a pulse oximeter. "It was the perfect storm." The baby's IV wasn't patent. The ED physician was outside of the ambulance and instructed them to re-intubate the baby. The baby was definitely already intubated. They went ahead and re-intubated the baby at her request. She had epi in her Med-pack and followed the NRP (neonatal resuscitation program guidelines). She said they couldn't move the baby to their transporter because there was no room to code the baby. The baby wasn't responding. ED physician wouldn't tell them to stop the code and wouldn't pronounce the baby. She then called the NICU Physician at Hospital B and explained the situation to him. He gave them permission to stop the code and he pronounced the baby over the phone.


During an interview on 08/16/17 at 9:32 AM with Ambulance 2D (Ambulance B-Neonatal RT) via telephone call he stated he received a call at 3:50 AM on 07/23/17. The ambulance (NICU) left at 4:01 AM and arrived at Hospital A at 4:30 AM. He observed 4 or 5 hospital staff members pointing to a parked ambulance. "I thought we were in the wrong building. In the ambulance I saw a baby on mom's chest. [Ambulance 2C-Neonatal RN] requested to go back inside the ER but the staff said the doctor won't let us back in. I intubated the baby and checked that the placement was good. Epi was given. The baby was cold upon our arrival. A total of Epi x3 was given with no results. The ED physician was not there until she was called. She was gone after the intubation. She stayed with us less than 2 minutes. We tried to resuscitate the baby for about 30 minutes. We asked for ED doctor to come out so she can assess and pronounce the baby." The physician refused. After the baby was pronounced by Physician B1, Ambulance 1B went on to Hospital B and "we" [NICU team/Care Flite] followed the ambulance.



During an interview on 08/21/17 at 3:19 PM and 08/22/17 at 4:27 PM with the EMT, of Ambulance 1 via telephone call, he said they received a call from dispatch to transport a pregnant woman from Hospital A to another facility. Upon arrival to Hospital A, the dispatch informed them that the woman was in active labor. EMT stated as they entered in the ED with a gurney, a staff met them and gave report while walking to the patient's ED room. The staff told them to hurry because the patient was about to give birth. He observed the ED physician was on the phone by a desk. As they entered the patient's room, he observed a baby on the bed. There were 2 nurses in the room and a respiratory therapist. He was asked where the mother was. EMT replied the mother was at the head of the bed and the baby was at the foot of the bed. He stated a nurse tried to stimulate the baby so she would cry. The baby was suctioned by a nurse and blankets were applied around the baby. He observed the baby was not crying. The baby was not cyanotic. The baby was weak. He took out the "OB kit." He called their supervisor for additional resource, like needing another EMS personnel as a second person at the back of the ambulance during transport.

The physician came in the room. We initiated the BVM process. "I started to see the baby's signs of color, from pink then to red." The heart rate was at 146. The O2 sats improved to 97%. The baby let out a cry. "I saw a little a bit of movement." The ED physician talked to a doctor on the phone. She wanted to establish an airway. The physician attempted 3 times but was unsuccessful. The intubation was done in between the BVM process. "My supervisor came in during the time of the first intubation."
After the second intubation attempt, the baby was declining. I saw blood coming out from her nose and a bit at the side of the mouth. At this time "I did not see the baby move." After the third intubation attempt the baby's heart rate decreased from 80s to 50s. The O2 sat was low from 80s to 50s-40s. We started the compressions. The baby's O2 sat never got up to the 90s. The ED physician rushed us out to transport the baby to Hospital B. We got the patients ready for transport and left the ER. As we were loading and strapping the patient, another ambulance came in. We did not know and we were not told that a NICU team ambulance was called to transport the baby." EMT stated "Had I known there was a NICU ambulance coming to transport the baby, I would not have moved the baby out from the ER."

When the NICU ambulance arrived, a nurse and a respiratory therapist came inside our ambulance and took over the baby's care. The ER physician was asked to come out to check on the baby. The physician came out in a little bit. I heard the NICU team said they were not going to move until the baby was stable. The physician left and went back to the ER. The NICU team continued resuscitating the baby. I was asked to get the physician back to the ambulance to assess and pronounced the baby. I went inside the ER and told the physician, but she refused to come out. I told the NICU team about it. The team called their physician and the baby was pronounced.

During all this time, the mother fainted once. After the baby was pronounced, we had all our attention to the mother. Mom wanted to hold her deceased baby and the request was granted. We transported mom and the baby (deceased) to Hospital B. The NICU ambulance followed us.



Hospital A's policy "EMTALA ...Duties, and Obligations" last revised 10/13/16 pages 2 and 4 required "...Pregnancy is defined as an emergency medical condition through delivery of the placenta...Stabilize...with respect to a woman in labor, the woman has delivered the child and the placenta..."


Hospital A's policy "EMTALA-Stabilizing Treatment" last revised 07/03/17 page 2 "...Special consideration shall be given to all pregnant up to delivery of the placenta..."


Hospital A's policy "EMTALA-Patient Transfer Policy" last revised 07/03/17 page 1, 2, and 3 "...This policy applies to all Hospital transfers...PROCESS: 4. Patient evaluation ...D. Patients shall routinely be examined and evaluated by the transferring physician before an attempt to transfer is made..."

APPROPRIATE TRANSFER

Tag No.: A2409

Based on interview and record review, the hospital (Hospital A) failed to provide appropriate transfers to 2 of 2 patients (Patient #1 and Patient #2) who presented in the emergency room (ED) on 07/22/17 and 07/23/17 respectively.

Findings included:

Patient #1 presented in Hospital A's ED on 07/22/17 at 11:07 PM. During triage Personnel #9 indicated the chief complaint was "left lower abdominal pain with dark brown vaginal discharge...onset...3 hours ago."

On 07/22/17 at 11:20 PM Physician #7 saw the patient. Physician #7 indicated "Chief Complaint pelvic pain/ pelvic pressure...3 hours ago...Timing: still present...pelvic pain was noted on the left side...weak...irregular...vaginal discharge (brownish-thick)...first pregnancy occurred in right uterus-full term..." Physician #7 noted the patient had a "didelphys" condition (rare condition of having 2 uterus). Blood work and obstetric (OB) sonogram were ordered.

On 07/23/17 at 1:35 AM a Memorandum of Transfer was initiated to take the patient to Hospital C. Physician progress notes indicated that at 1:55 AM [07/23/17] Patient #1 was accepted at Hospital C.

On 07/23/17 at 3:30 AM Physician #7 indicated Patient #1 "experienced abdominal contractions...in her 2nd trimester of pregnancy...had a precipitate vaginal delivery of a preterm baby."

Ambulance 1 with Personnel 1A and 1B entered Patient #1's room immediately after the precipitous delivery of Patient #2. Their purpose was to transfer Patient #1 to Hospital C per MOT. Ambulance 1 personnel could not immediately transfer Patient #1 due they assisted in the resuscitation of Patient #2.

On 07/23/17 at 3:45 AM Physician #7 contacted Physician B1 and accepted the "newborn" transfer to Hospital B. Physician B1 informed Physician #7 that he would be sending a "NICU transport team from Hospital B" to pick-up and transport Patient #2. At 4:03 AM the "NICU transport team" informed Physician #7 their estimated time of arrival would be at "4:30 AM."

Ambulance 1 personnel were instructed by Physician #7 to immediately transfer both Patient #1 and Patient #2 to Hospital B. At 4:30 AM Ambulance 1 personnel conducted an assessment and prepared the patients for transport.

Both Patient #1 and Patient #2 were loaded in one gurney and in one ambulance for the transfer. This was not a safe manner to transport Patient #1 and Patient #2. There was no evidence that Ambulance 1 was provided with the following: MOTs, and/or appropriate medical records, and/or appropriate laboratory/ultrasound reports. The undated and untimed "Physician Certification" did not describe the "Summary of Risks and Benefits" associated with the transfer.

Physician #7 did not wait for the "NICU team transport" to arrive. The "NICU team transport" was equipped with specialized equipment and supplies for neonates.

During an interview on 08/14/17 at 2:30 PM with ED Physician #7 (Hospital A) via telephone call the physician confirmed she was informed by Physician B1 (Hospital B) that he was sending a NICU transport team.

During an interview on 08/15/17 at 1:05 PM via phone, Physician B1 said there was no paperwork for Patient #1 or #2 that was sent from Hospital A at the time of the transfer.

During an interview on 08/15/17 at 1:38 PM with Ambulance 2C she said Hospital A didn't send MOTs and other documents for Patients #1 and #2 at the time of their transfer to Hospital B.

During a telephone interview on 08/17/17 at 4:20 PM Personnel #4 confirmed the MOTs and other documents were faxed to Hospital B on 07/23/17, Patient #1 at 11:34 AM and Patient #2 at 11:36 AM.

Hospital A policy "EMTALA-Patient Transfer Policy" last revised 07/03/17 page 1, 2, and 3 "...This policy applies to all Hospital transfers, and all transfers shall include use of Memorandum of Transfer (MOT)...PROCESS: 4. Patient evaluation...D. Patients shall routinely be examined and evaluated by the transferring physician before an attempt to transfer is made...7...C. The hospital shall not transfer a patient with an emergency medical condition who has not been stabilize unless...a physician has signed a certification, which includes a summary of the risks and benefits..."