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Based on observation, interview, medical record review and document review, the hospital failed to comply with the Emergency Medical Treatment and Active Labor Act (EMTALA) as evidenced by:

1. The facility failed to post required EMTALA signage in a conspicuous place in the Emergency Department's (ED) designated Fast-Track area. (Refer to Tag 2402).
2. The facility failed to provide an adequate medical screening exam (MSE) for 2 of 26 sampled patients (Patient 1 and 2). (Refer to Tag 2406).
3. The facility failed to provide adequate stabilizing treatment and continued treatment for 2 of 26 sampled patients (Patient 1 and 2). (Refer to Tag 2407).
4, The facility failed to appropriately transfer 1 of 26 sampled patients (Patient 1) to another hospital.. (Refer to Tag 2409).


These failures potentially resulted in delays to patients receiving necessary medical screening, needed treatments, stabilization, and appropriate transfers which could result in harm to patients' health and safety, up to and including death, and potentially contributed to Patient 1's worsening emergency medical condition (EMC) and potentially to Patient 2's death.

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Based on observation, interview, and facility policy review, the facility failed to post signage in the Emergency Department (ED) Fast-Track Area (An area of the Emergency Department for the treatment and exam of patients presenting with a lower acuity) specifying the rights of individuals with respect to the Emergency Medical Treatment and Labor Act (EMTALA).

This failure resulted in the potential for patients to not know their rights to receive a medical screening examination or treatment for their emergent medical condition, including active labor.

Findings:

On 4/20/2022 at 11:01 a.m., a tour was conducted of the Emergency Department (ED) Fast-Track Area with the ED Nurse Supervisor (EDNS). The Fast Track area was accessed through a separate door in the ED waiting room, down a hallway, and then opened to a large area containing a centralized nurse station surrounded by nine patient bays. No postings or signage related to patient rights to examination, treatment, or Medicaid participation were observed in the Fast-Track entrance, hallways, or treatment and exam areas.

During the tour conducted on 4/20/2022 at 11:01 a.m., the EDNS indicated there were no EMTALA signs posted in the Fast Track area.

On 4/22/2022 at 9:11 a.m., an interview was conducted with the Patient Care Executive (PCE) and the Director of Quality (DoC). The PCE indicated the ED Fast Track area was designated for emergency department patients presenting with a lower acuity for treatment and exam purposes.

Review of a hospital policy, "EMTALA - Compliance with EMTALA", effective 3/17/2022, was conducted. The policy indicated, "1. Signage. The Hospital will post signs in the locations and form required by CMS that specifies the following: a. The rights of individuals, including women in labor, to examination and treatment for Emergency Medical Conditions; and b. The Hospital participates in the Medicaid Program."

42125

Based on observation, interview and record review, in accordance with hospital policies and/or medical staff bylaws, the emergency department (ED) at [Hospital] had the capability and capacity of providing medical screening examination (MSE) and continuous monitoring for two of 26 patients, a woman in labor (Patient 1) and a newborn infant (Patient 2), when:

1. After the emergency department nurse practitioner (EDNP 2) determined that Patient 2 required emergency medical care, the emergency department physician, (EDMD 1) did not provide a complete MSE and provide continuous monitoring that was needed to direct and provide the appropriate stabilizing medical treatment.
2. The ED did not have the required equipment to provide an MSE and continuous monitoring of Patient 2.
3. The ED staff were not prepared to provide the Cardiopulmonary Resuscitation (emergency procedure that can help with breathing, circulation, and survival of patients) on Patient 2.
4. EDMD1 did not complete a MSE on Patient 1's arrival to the ED
5. Patient 1 had a MSE about one and half hours after arrival and minutes before her
transfer.
6. The ED staff were not prepared for resuscitation of a patient in the third stage of labor, and delivery of the placenta.

The failure to provide a timely MSE contributed to a delay in care and stabilization of Patient 1 which contributed to the negative impact on Patient 1's health. The failure of the [Hospital] to provide an MSE and continuous monitoring affected and delayed Patient 2's medical care and healthcare outcomes.

Findings:

The chart of newborn premature infant, Patient 2, indicated the following timeline of events on 08/23/2020:

At 1:55 p.m., the Cardiopulmonary Resuscitation (CPR) Arrest sheet indicated Patient 2 arrived at ambulance bay entrance (ED doors where ambulances arrive and depart) and was assigned ESI 1 (Emergency Severity Index (ESI) is a tool for use in emergency department to rank patients into five groups, from level 1 (most urgent) to level 5 (least urgent)).

The documentation by EDNP 2 indicated Patient 2 was between mom's legs, not breathing, cyanotic, (blue color due to lack of oxygen), pulseless and Cardiopulmonary Resuscitation (CPR) was started. Patient 2, still connected to the mother, (Patient 1) via the umbilical cord (a cord with veins and artery connecting baby to the mother's placenta which allows the baby to receive blood oxygen and nutrients) was brought into the ED for further evaluation.

At 2:00 p.m., the CPR Arrest sheet indicated CPR was in progress for Patient 2. The CPR Arrest sheet indicated that "all medications [for Patient 2 were] based off of Broselow tape. Broselow Pediatric Emergency Tape is a color-coded tape measure that is used as a reference for pediatric emergencies. Included on this tape are pre-calculated emergency medications doses and equipment sizes for infants and children weighing 3 to 36 Kg (kilograms, Kg, is a unit of weight) or 6.6 to 80 pounds and heights of 46.8 to 143.3 cm (centimeter, cm, a measure of length) or 19.1 to 56.3 inches. The patient record indicated Patient 2 was 0.45 kg (one pound), 30.5 cm (12 inches) and born at 26 weeks old. The patient record did not indicate what Broselow tape color or weight was used to calculate the medication doses or equipment for Patient 2.

The documentation by EDNP 2 indicated EDMD 1 was at Patient 2' s bedside in the ED. EDNP 2's documentation indicated Patient 2's umbilical cord was clamped, placed on the warmer and CPR continued. The documentation by EDNP 2 indicated oxygen was given to Patient 2, cyanosis improved, and temperature 30.5 to 35.7C (Celsius, C, is a measurement of heat) or 96.3 Fahrenheit (F) improved. (The average temperature of a baby is about 36.4 C or 97.5 F).

From 2:01 p.m. to 2:33 p.m., CPR Arrest sheet for Patient 2 did not indicate ongoing CPR or continuous monitoring of heart rate (HR, greater than 100 is normal in newborns), heart rhythm, respiratory rate (RR), pulses present or absent, mode of respiration delivery, amount of oxygen delivered, oxygen saturation (O2 Sat, concentration of oxygen in blood, measured in percent, normal is 85% to 93%), end title carbon dioxide (EtCO2, a product of exhaled breath), temperature, or fluid administered.

At 2:24 p.m., the patient record indicated the first dose of medication was given to Patient 2, Narcan 0.7 ml (milliliters, ml, a measure of volume. Narcan was a medication to reverse opioid overdose; the normal infant dose is based on weight, 0.1 mg/kg or 0.2 mg/pound). The patient record did not indicate the dose (mg/kg) or route (via a vein, mouth, rectum, muscle, skin) the medication was given. The patient record did not indicate the reason or response to the medication.

At 2:26 p.m., the patient record indicated Patient 2 was intubated (breathing tube placed in mouth and lungs to assist breathing and provide oxygen) by EDMD 1. The documentation by EDMD 1 indicated CPR continued until "intubation equipment available" and the "Broselow tape used for meds [medication] and doses". After intubation, EDMD 1 documented Patient 2 had "good bilateral breath sounds [receiving oxygen in lungs]", and "became pink and remained pink".

At 2:34 p.m., the patient record indicated Patient 2 had a heart rate and rhythm of sinus bradycardia (heart rate in neonates below 100 beats per minute is sinus bradycardia (SB),and a slow heart rate). The chart indicated Patient 2 received epinephrine 0.65 ml of 1mg/10ml )(epinephrine is medication used to increase heart rate and blood pressure during CPR). The normal dose for newborns is 0.01-0.03 mg/kg intravenous, (delivered via a vein) every 3 to 5 minutes and is based on the infant ' s weight). The patient record did not indicate the route the medication was given. The record did not indicate the weight used to calculate the medication dose. The patient record did not indicate Patient 2's heart rate or response to the medication given.

From 2:34 p.m. to 2:45 p.m., the patient record did not indicate ongoing CPR or continuous monitoring of HR, heart rhythm, RR, pulses present or absent, mode of oxygen delivery, oxygen saturation (O2 Sat), end title carbon dioxide (EtC02), temperature or fluid administered.

At 2:35 p.m., the CPR Arrest sheet indicated the umbilical cord vein intravenous (a vein used to provide medications and fluids) access was started on Patient 2. CPR Arrest sheet indicated atropine 1.3 ml (atropine, a medication used to speed up the heart rate; there is no recommended dose for premature infants during CPR, and 0.1 mg dose of Atropine could result in overdose in infants less than 5 kg or 11 pounds). The patient record did not indicate the dose (mg/kg) or route the medication was given. The patient record did not indicate the reason or patient response to the medication given.

At 2:36 p.m., patient record indicated admission unit clerk, (EDUC), called [Hospital] and "told" [Hospital] "going to transfer mother and baby ...the mother will go to L&D [labor and delivery, hospital unit] and baby will go to NICU because it's intubated".

The documentation by EDMD 1 indicated EDNP 2 spoke with the neonatal intensive care unit (NICU, a area of hospital for severely ill infants) physician, NMD. EDMD 1's documentation indicated "a phone call was made for both OB/GYN (physician for women's health and pregnancy) transfer as well as pediatric (specialist for children) transfer".

At 2:37 p.m., the CPR Arrest sheet indicated atropine 1.3 ml was given to Patient 2. The patient record did not indicate the dose (mg/kg) or route the medication was given. The patient record did not indicate the reason or patient response to the medication given.

At 2:40 p.m., the CPR Arrest sheet indicated Narcan 0.7ml was given to Patient 2. The patient record did not indicate the dose (mg/kg) or route the medication was given. The patient record did not indicate the reason or patient response to the medication given.

At 2:44 p.m., the CPR Arrest sheet indicated peripheral intravenous (PIV; access to extremity vein used to provide medications and fluids) access was obtained.

At 2:46 p.m., the CPR Arrest sheet indicated sinus bradycardia. The CPR Arrest sheet indicated atropine 1.3 ml was given to Patient 2. The patient record did not indicate the dose (mg/kg) or route the medication was given. The patient record did not indicate the reason or response to the medication given.

From 2:47 p.m. to 3:28 p.m., the patient record did not indicate ongoing CPR or continuous monitoring. CPR Arrest sheet did not indicate records of ongoing CPR or continuous monitoring of HR, heart rhythm, RR, pulses present or absent, oxygen delivery, oxygen saturation, end title carbon dioxide (EtC02), temperature, or fluid administered.

At 2:57 p.m., the CPR Arrest sheet indicated epinephrine 0.65 ml of 1mg/10ml was given to Patient 2. The patient record did not indicate the route the medication was given. The patient record did not indicate the Patient 2's heart rate or response to the medication given.

At 2:58 p.m., the CPR Arrest sheet indicated atropine 1.3 ml was given to Patient 2. The patient record did not indicate the dose (mg/kg) or route the medication was given. The patient record did not indicate the reason or response to the medication given.

At 3:00 p.m., the CPR Arrest sheet indicated epinephrine 0.65 ml of 1mg/10ml was given to Patient 2. The patient record did not indicate the route the medication was given. The patient record did not indicate the Patient 2' s heart rate or patient response to the medication givenAt 3:03 p.m., the CPR Arrest sheet indicated Narcan 0.7ml was given to Patient 2. The patient record did not indicate the dose (mg/kg) or route the medication was given. The patient record did not indicate the reason or response to the medication given.

At 3:17 p.m., the CPR Arrest sheet indicated epinephrine 0.65 ml of 1mg/10ml was given to Patient 2. The patient record did not indicate the route the medication was given. The patient record did not indicate the Patient 2's heart rate or response to the medication given.

At 3:29 p.m., chart indicated EDNP 1 spoke to NICU physician, NMD at [Hospital]. The documentation by EDMD 1 indicated "Physician Certification Statement Medical Necessity for Non-Emergency Ambulance Transportation" form was completed for the ambulance service by MD 1. The form indicated Patient 2 was to be transferred because "services not available ...NICU". The form did not indicate the time it was completed. The chart indicated, EDUC informed emergency room nurse practitioner (EDNP) 1, an ambulance was coming to pick-up Patient 2 for transfer to [Hospital].

At 3:29 p.m., the CPR Arrest sheet indicated narrow QRS asystole for one minute, pause narrow complex, and sinus bradycardia and heart rate of 46. CPR Arrest sheet did not indicate continuous monitoring of RR, pulses present or absent, oxygen delivery, oxygen saturation, end title carbon dioxide (EtC02), temperature or fluid administered.

At 3:34 p.m., the CPR Arrest sheet indicated Patient 2 was in asystole (no heart rhythm). The documentation by EDMD 1 indicated Patient 2 had a bradycardia (low heart rate) in the 10's to 20's, and CPR was continued for another 10 minutes. EDMD 1's documentation occurred at 6:25 p.m., after Patient 2's death.

At 3:45 p.m., the patient record indicated the death of Patient 2 was pronounced by EDMD 1.

At 6:14 p.m., the chart indicated EDNP 2 called NICU physician at transferring [Facility], NMD and updated NMD about Patient 2's status.

During a concurrent interview, observation, and document review in the ED on 4/20/2022 at 1:19 p.m. with [Hospital] leadership team (Team) which included the Patient Care Executive (PCE), Emergency Department Nurse Director (EDND), Director of Quality (DoC), Emergency Department Nurse Supervisor (EDNS). The Team stated that the ED has a pediatric resuscitation cart (a cart ready to use containing emergency equipment for delivering oxygen, suctioning, starting IV, intubating and monitoring). The Team produced a Broselow tape stored in the cart and indicated the drawers were color-coded and reflected the color coding on the Broselow Tape. The Team stated, the ED used the Broselow tape to determine the dose of medication and equipment needed during infant and pediatric CPR. The Team stated the "grey" color was used for newborn patients weighing 3 to 5 kg (6.6 to 8.8 pounds). The Team stated the ED did not have a guide for patient's that were 0.45 kg (one pound) and 30.5 cm (12 inches). The Team were unable to find resuscitation equipment necessary to support a newborn or premature infant in distress on the pediatric resuscitation cart. The Team explained there was no resuscitation equipment for infants below 3 to 5 Kg in the cart and indicated the equipment was on the "Panda warmer [a warming bed for newborn infants]". The Team located the Panda warmer about 1 minute away from the pediatric resuscitation cart in an ED hallway.The Team searched the Panda warmer drawers for newborn and premature infant equipment for over 25 minutes, but was unable to locate resuscitation equipment like different sizes to intubation tubes and blades (items needed to place a breathing tube to support respirations and provide oxygen delivery), different sizes of oxygen masks and suction catheters, IV access tools, and monitoring tools. The drawers were observed to be unlabeled and unorganized. The Team stated the equipment was not available. The Team stated if resuscitation equipment was not available during CPR, they would call central supply. The Team stated they did not know how long it would take to obtain the needed equipment. The Team acknowledged they did not know the medications or process for neonatal (newborn) resuscitation and CPR. The Team indicated they had not participated in educational program or training for newborn term or premature infants. The Team indicated "these are planned".

The DoC was asked for policy and procedures for emergency procedures, ACLS and PALS, and neonatal resuscitation. DoC stated the Hospital did not have any.

During a concurrent interview and record review, on 4/21/2022 at 4:02 p.m. with EDNP 2, EDNP 2 stated, "I was the only one at the car" when Patient 2 arrived. EDNP 2 stated, Patient 1 was "delivering the baby or delivered baby". EDNP stated Patient 2 was still attached to mom via the umbilical cord, was "cyanotic" and "not breathing". EDNP 2 stated she started CPR. EDNP 2 stated there was no "oxygen at the car". EDNP stated that she was the "most capable" to care for Patient 2 because her eight years of experience as a NICU nurse. EDNP 2 stated MD 1 "was not at the car". EDNP 2 stated in the ED, EDMD 1 was at the head of Patient 2's bed and in charge of Patient 2's care. EDNP 2 acknowledged it took 26 minutes to intubate Patient 2 because intubation equipment was not available. EDNP acknowledged it took 35 minutes to obtain IV access for Patient 2. EDNP stated that she could not recall what steps were taken to acquire the necessary items intubate and gain IV access. EDNP stated she could not recall what care was provided to Patient 2 while waiting for resuscitation equipment. EDNP 2 stated that if the necessary equipment was not available and help was needed to care for Patient 2, she would have called anesthesia team to help intubate and obtain IV access. EDNP 2 indicated anesthesia was not called to help. EDNP 2 acknowledged she charted after Patient 2's death. EDNP 2 stated, that her "world disappeared" and she "could not see the monitors". EDNP 2 acknowledged that Patient 2's record did not indicate documented ongoing CPR or continuous monitoring of HR, heart rhythm, RR, pulses present or absent, oxygen delivery, oxygen saturation, EtC02, temperature or fluid administered. EDNP 2 acknowledged she documented that Patient 2 was in "serve respiratory distress ...Respiratory effort labored ...severe distress". EDNP 2 acknowledged she charted that Patient 2's temperature "improved 30.5 to 35.7 and skin color improved". EDNP acknowledged that EDMD 1 charted, Patient 2 "did become pink and remained pink" after intubation. EDNP 2 stated that this indicated Patient 2 had " better perfusion (blood flow and oxygen to the body)". EDNP 2 stated, she could not recall why medication were given, the doses of medications given or the response to the medications. EDNP 2 stated, EDMD 1 ordered the medications and acknowledged "all medications were based off Broselow". EDNP 2 reviewed the Broselow tape and acknowledged the grey area was for infants above 3kg (6.6 pounds). NP stated the use of the Broselow tape for medications was based on weight and not appropriated for Patient 2 who weighed 0.45 Kg (one pound). EDNP 2 acknowledged the medication doses given to Patient 2 were greater than three times the recommended doses. EDNP 2 stated that "too much atropine can be toxic".

During an interview on 4/21/2022 at 12:14 p.m., with the on-call anesthesiologists (physicians trained in resuscitation, CPR, intubation and IV access) who were at [Hospital] during Patient 1 and 2's stay, the on-call anesthesiologists (OCA) 1 and 2 stated that the anesthesia team was available to help care for Patient 1 and Patient 2 in the ED; but neither were called. OCA 1 stated that the anesthesia team is called about once a month to help in the ED with intubations and IV access.

During a concurrent interview and record review, on 4/21/2022 at 11:38 a.m. with EDRN 1, EDRN 1 stated he went to the car located at the ambulance bay, and helped EDNP 1 with the care of Patient 1 and 2. EDRN 1 stated that EDMD 1 was not at the car. EDRN 1 stated Patient 2 was covered in blood and attached to Patient 1 via the umbilical cord. EDRN 1 stated Patient 2, a premature infant, "appeared small". EDRN 1 stated CPR was started on Patient 2. EDRN 1 stated that Patient 1 and 2 were taken into the ED and placed in the same room. EDRN 1 stated, EDMD 1 was in the emergency room and "in-charge" of Patients 1 and 2. EDRN 1 stated, Patient 2 was surrounded by ED staff and he could not see Patient 2 or the monitors. EDRN 1 stated that as directed by EDMD 1, he gave medications to Patient 2. EDRN 1 indicated EDMD 1 used the Broselow grey colored-coded area for a 3 to 5 Kg (6.6 to 8.8 pounds) baby for medication doses. EDRN 1 stated that he was unaware of Patient 2's weight. EDRN 1 stated repeated doses of atropine and epinephrine were given to Patient 2. EDRN 1 stated with each dose of atropine Patient 2's heart rate got slower. EDRN 1 acknowledged he did not record Patient 2's HR, RR, temperature, heart rhythm, oxygen delivery, O2 saturation, EtCO2, pulse, reason for medications or response to medications. EDRN 1 acknowledged that he did not know the appropriate medication doses, resuscitation or CPR requirements for a premature or newborn infant. EDRN 1 stated the ED did not have a guide for patient's that weighed 0.45 kg (1 pound). EDRN 1 stated the hospital has not provided an educational program or training for neonatal codes.

During a concurrent interview and record review, on 4/21/2022 at 4:02 p.m. with Emergency Department Nursing Supervisor, (EDNS), EDNS stated that she was not present for the resuscitation of Patient 2. EDNS stated when a patient arrives at the ED, the staff start care. EDNS acknowledged the chart indicated Patient 2 was an ESI 1. EDNS stated, an ESI 1 signals the need for "immediate attention" and "most critical" patients. EDNS, stated the "typical process", for patient classified as ESI 1, is to place the patient on a "cardiac monitor" and obtain vitals (BP, HR, RR, pulse, O2 Sat, temperature), and obtain IV access, EKG and labs. EDNS stated the goal is to "keep the patient alive". EDNS acknowledged during review of Patient 2's chart, the [Hospital] was unable to locate nursing documentation of continuous monitoring, vitals sign or laboratory values. EDNS stated that she could not locate documentation of Patient 2's response to treatment or medications.

During review of Patient 2's records, EDNS acknowledged the record indicated "respiratory effort labored", "heart rate", and after intubation became "pink". EDNS stated, an infant with a heart rate and breathing is "living". EDNS indicated after intubation and Patient 2 turning "pink" indicated "circulation (delivery of blood and oxygen in the body)". EDNS stated, that if the necessary tools for resuscitation, CPR and emergency stabilization are not available, the nurses would obtain the "equipment from central supply". EDNS was unable to state how much time this would take.

During a phone interview on 4/21/2022 at 1:05 p.m. with EDNP 1, EDNP 1 stated that he did not have Patient 2's record in front of him, but could "recall exactly" the events that occurred on 8/23/2022 in the "main ED". EDNP 1 stated the events were "crazy ...everyone ...chaos". EDNP 1 stated that he did not provide care for Patient 2. EDNP 1 stated that at the request of EDMD 1, he called the NICU physician, NMD to discuss the transfer of Patient 2 to [receiving Hospital]. EDNP 1 stated, that he was acting as the "scribe" for EDMD 1 whom he had received information from. EDNP 1 stated that if there was a change in Patient 2's status, EDMD 1 should have notified NMD. EDNP 1 stated that under EMTALA, ED patients "immediately" receive a medical screening exam and are "stabilized". EDNP 1 stated that if a patient is transferred, the provider needs to speak with the receiving facility to accept transfer and provide documentation. EDNP 1 indicated that if the equipment required for CPR or resuscitation was not available, he would ask the charge nurse for help. EDNP 1 indicated he was not familiar with the Broselow tape, or the location of the emergency resuscitation carts and Panda warmer. EDNP 1 stated he had not participated in a [Hospital] educational program or training for CPR or neonatal resuscitation.

During an interview and concurrent record review on 4/21/2022 at 12:24 p.m. with EDMD 2, EDMD 2 acknowledged his name was in Patient 2's chart. EDMD 2 stated that he was not involved with the care of Patient 2. EDMD 2 stated that he is "familiar" with EMTALA requirements. EDMD 2 stated that EMTALA is based on "cascade of events", and "no set process". EDMD 2 stated that the resuscitation of a newborn infant is based on a "cascade of interventions". EDMD 2 stated that emergency physicians are not required to have PALS or neonatal resuscitation certification. EDMD 2 indicated he was not familiar with the Broselow tape for pediatric resuscitation. EDMD 2 indicated that if resuscitation equipment is not available, he would obtain it from "central supply". EDMD 2 indicated that if he needed help, he could call anesthesia for intubation and IV access.

During an interview and concurrent document review on 4/22/2022 at 11:58 a.m. with the Chief Medical Officer (CMO), the CMO stated "all staff", including physicians, are to follow EMTALA policy and procedures. The CMO indicated that the "intent" of EMTALA was for ED patients to be "screened", "evaluated", if appropriate transferred" to a "receiving" hospital, and "communicate" with the receiving hospital about patients being transferred. CMO indicated that "all clinicians" have annual EMTALA training. The CMO acknowledged Patient 2 arrived at the [Hospital] at 1:55 p.m., but could not explain why there was a delay in care, unavailable equipment and a lack of documentation. CMO stated a history and physical should include vital signs, chief complaint, "head to toe exam", review of labs and x-rays.

During an interview and concurrent document review on 4/25/2022 at 12:00 p.m. with Labor and Delivery Physician (LDMD) at receiving facility, LDMD stated that the NICU team was called by [Hospital] and was notified of Patient 2's transfer. LDMD stated that NICU physician, NMD, was "waiting for baby" arrival. LDMD stated that the baby never arrived. LDMD stated that NICU resources were "wasted" waiting and "not knowing what needed to be done".

During an interview and concurrent document review on 5/4/2022 at 2:00 p.m. with EDMD 1, EDMD 1 stated that he recalled the events of Patient 2's care and "everything that was done is documented in chart". EDMD 1 stated he was at the car helping care for Patient 1 and 2. EDMD 1 stated the smallest mask to provide oxygen to Patient 2 was an adult mask. EDMD 1 stated he did not know what equipment was on the pediatric code resuscitation cart, and his "first exposure" was during the care of Patient 2. EDMD 1 stated that he had "not been exposed" to the Panda warmer. EDMD 1 stated it took "90 seconds" to get resuscitation equipment and, after arrival, to obtain equipment took another "90 seconds" to intubate Patient 2. EDMD 1 stated Patient 1 "pinked-up after intubation ...and CPR was effective". EDMD 1 stated that he intubated Patient 2 "within 90 seconds" after equipment was available. EDMD 1 stated the Broselow tape was a "mechanical mechanism to measure and weigh a child..and gives the doses for all medications". EDMD 1 stated that EDNP 1 called the NICU and IMD. EDMD 1 stated that he had EMTALA training "two months ago". EDMD 1 stated EMTALA "has to do with transferring patients and prevent dumping of patients". EDMD 1 stated that he was board ceritified in emergency medicine and it was not required to have certifications on pediatric and neonatal CPR and resuscitation.

LDMD stated an infant born at "26 weeks is viable [can survive]". LDMD stated a premature infant with a heart rate and respiratory rate would be "considered still alive and would resuscitate [perform CPR]". LDMD stated that an infant that turns pink after intubation indicates "good oxygenation ...perfusion [blood flow and oxygen to the body] is good". LDMD stated the Broselow "grey colored zone" was "not for a 26 week" premature infant. LDMD stated that she was "not familiar with atropine being in the "neonatal resuscitation algorithm [standard of care of CPR on a newborn]". LDMD stated that a 26 week "baby could be saved" and it appeared the [Hospital] "panicked".

Review of "Medical Staff Rules and Regulations", last revision 9/20/2011, indicated [Hospital] medical staff will follow Regulations Policy and Procedures outlined in the COBRA/EMTALA Regulations, section Medical Screening Exam: "The process required to reach within a reasonable clinical confidence, the point at which it can be determined whether an emergency medical condition exists or a woman is in labor. The Medical Screening Exam is an ongoing process, including monitoring of the individual, until the individual is stabilized or transferred".

Review of the [Hospital] policy titled, "Transfer of individual with or without an Emergency Medical Condition (EMC) EMTALA", effective 10/10/2018, approved 10/18/2018, next review 10/10/2019. The policy indicated [Hospital] "will comply with the Emergency Medical Treatment and Active Labor Act (EMTALA) ... Capability: The physical space, equipment, staff, supplies and services (e.g., surgery, intensive care, pediatrics, obstetrics and psychiatry) ... To stabilize: With respect to emergency condition, to either provide such medical treatment of the condition ...Stable for Transfer... the treating physician has determined, with reasonable clinical confidence that an individual i.e., expected to leave the Hospital and be received at the second Hospital, with no material deterioration of his/her medical condition..."

Review of the [Hospital] policy titled, "Acceptance/interhospital Transfer Procedure", effective 5/5/2016, approved 5/5/2016, next review 5/17/2017. indicated the "physician's responsibilities ..."provide an examination and necessary stabilizing treatment". Review of national guidelines, according to American College of Obstetricians and Gynecologists (ACOG), the nation's leading group of physicians that provides guidelines and the standard of care, indicate "stillborn infant has been defined as a child of at least 20 weeks gestation or at least 400 gm weight at delivery which has not breathed after delivery. The criterion of life is the presence of a heartbeat after complete expulsion or extraction of the child from its mother. The U.S. National Center for Health Statistics defines fetal death as the delivery of a fetus showing no signs of life as indicated by the absence of breathing, heartbeats, pulsation of the umbilical cord, or definite movements of voluntary muscles." https://www.acog.org/clinical/clinical-guidance/obstetric-care consensus/articles/2020/03/management-of-stillbirth. Accessed 04/20/2022.

Review of national guidelines, according to Part 5: Neonatal Resuscitation 2020 American Heart Association Guidelines for Cardiopulmonary (CPR). The guidelines indicated the Resuscitation and Emergency Cardiovascular Care for Newborn resuscitation: 1. Most newly born infants do not require immediate cord clamping or resuscitation. 2. Inflation and ventilation of the lungs are the priority in newly born infants who need support after birth. 3. Heart rate is assessed initially by auscultation and/or palpation. 4 Assessment of Heart Rate. 5. Electrocardiography is an important adjuncts in babies requiring resuscitation. 6. Pulse oximetry is used to guide oxygen therapy and meet oxygen saturation goals. 7. PPV remains the primary method for providing support for newborns who are apneic, bradycardic, or demonstrate inadequate respiratory effort. Most babies will respond to this intervention. PPV may be initiated with air (21% oxygen) in term and late preterm babies, and up to 30% oxygen in preterm babies. 8. Chest compressions are provided if there is a poor heart rate response to ventilation after appropriate ventilation corrective steps, which preferably include endotracheal intubation. 9. The heart rate response to chest compressions and medications should be monitored electrocardiographically. 10. If the response to chest compressions is poor, it may be reasonable to provide epinephrine, preferably via the intravenous route. 11. Failure to respond to epinephrine in a newborn with history or examination consistent with blood loss may require volume expansion. 12. When vascular access is required in the newly born, the umbilical venous route is preferred. When intravenous access is not feasible, the intraosseous route may be considered. 13. Medications, if the heart rate remains less than 60/min despite 60 seconds of chest compressions and adequate PPV, epinephrine should be administered, ideally via the intravenous route. Atropine is not indicated in the guidelines. 14. If all these steps of resuscitation are effectively completed and there is no heart rate response by 20 minutes, redirection of care should be discussed with the team and family. (https://cpr.heart.org/en/resuscitation-science/cpr-and-ecc-guidelines/neonatal-resuscitation. Accessed 4/20/2022)

Review of peer review article Journal of Anesthesiology Clinical Pharmacology, the article indicated that if an atropine dose of 0.02 mg/kg was given to an1 kg neonate, the neonate would receive a 5-fold over-dose of atropine. The article also indicated -very low doses of atropine (3.6 µg/kg or less) might cause slowing of the heart rate and paradoxical bradycardia. J Anaesthesiol Clin Pharmacol. 2017 Apr-Jun; 33(2): 282-283. doi: 10.4103/0970-9185.209735. Accessed 4/21/2022

The chart of Patient 1 indicated the following timeline of events before and after the interhospital transfer on 08/23/2020:

At 1:55 p.m., the patient record indicated Patient 1 arrived at [Hospital] ambulance bay (ED entrance for ambulances).The documentation by emergency department nurse practitioner (EDNP) 2, indicated Patient 1 delivered an infant. The chart indicated Patient 2 who was still attached to Patient 1 via the umbilical cord. The chart indicated Patient 1 and 2 were brought into the emergency department (ED) and placed in the same room. EDNP 2's documentation occurred after Patient 1's departure from [Hospital]. The documentation by emergency department registered nurse (EDRN) 1 indicated Patient 1 was "in distress due to pain, patient in labor ...patient presented to ED by private car in active labor with neonate delivered ...rate 100 ' s, heart rhythm, sinus tachycardia ...placenta not delivered on time of arrival." EDRN 1's documentation occurred after Patient 1's departure from [Hospital].

At 2:00 p.m., the patient record indicated Patient 1 was placed on non-invasive blood pressure monitor and continuous pulse oximetry. The chart did not indicate Patient 1 had an evaluation by an EDNP or physician.

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Based on interview, record review and hospital policy review, the hospital failed to ensure stabilizing treatment and continuous monitoring relevant to the emergency medical condition (EMC) for 2 out of 26 sampled patients (Patient 1 and 2) and ensure no material deterioration of the condition would likely occur, when;

1. Patient 1 was not provided stabilizing treatment and continuous monitoring after the delivery of a premature newborn infant and for the assessment of complications after birth.

2. Patient 2 was not provided adequate treatment and continuous monitoring after her premature birth for respiratory distress and cardiac arrest.

This failure potentially contributed to Patient 1's worsening Emergency Medical Condition (EMC), potentially contributed to Patient 2's death, and had the potential to place other patients at a high risk for harm.

Findings:

1. A review of Patient 1's emergency department's (ED) electronic medical record (EMR), dated 8/23/2020 reflected the following timeline:

At 2:03 p.m., the Doctor Notes reflected Patient 1 was 28 weeks pregnant and had delivered Patient 2 in the front passenger seat of a private car in the ED ambulance bay. Patient 1 and Patient 2 were brought into the ED together on a gurney and placed in room 1.

At 2:15 p.m., the ED Registration Record reflected Patient 1 was admitted to the ED.

At 2:34 p.m., Patient 1 was triaged with an Emergency Screening Index (ESI, a tool to prioritize when a patient is seen and the resources needed to care for the patient with a scale of 1 to 5, level 1 being the most severe) of 1. Her Symptomatic Inflammatory Response Syndrome (SIRS, an exaggerated defense response of the body to an infection)/Sepsis (a potentially life-threatening condition that occurs when the body's response to an infection damages its own tissues) Screen (a tool used to screen patients for sepsis) was negative.

At 2:56 p.m., the Emergency Flow Sheet Record reflected Patient 1's first set of vital signs which included: blood pressure (BP, normal range is between 90/60 millimeters of mercury (mm HG, a unit of measurement) to 120/80 mm Hg) 107/49, heart rate (HR, normal range is between 60 to 100 beats per minute) 110, respiratory rate (RR, normal range is between 12 to 20 breaths per minute) 16, temperature (T) blank, pain (P, pain level between 1-10, and 10 being the highest) 10, and oxygen saturation (O2 Sat, how much oxygen is carried in your bloodstream with a normal level between 95-100%) 100% on room air. The EMR further indicated the following vital signs for Patient 1:

3:06 p.m., BP 82/20, HR 111, RR 18, T blank, P 10, O2 Sat 100% on room air.
3:11 p.m., BP 103/66, HR 112, RR 18, T blank, P 10, O2 Sat 100% on room air.
3:16 p.m., BP 123/71, HR 85, RR 18, T blank, P 10, O2 Sat 100% on room air.
3:22 p.m., BP 132/63, HR 90, RR 18, T 26.8 Degree Celsius ('C, a measurement of temperature with a normal body temperature range between 36.1 to 37.2 'C), P 10, O2 Sat 100% on room air.
3:30 p.m., BP 220/110, HR 108, RR, T blank, P 10, O2 Sat 100% on 100% non-rebreather (NRB, a type of mask that allows high concentrations of oxygen) mask.
3:35 p.m., BP 250/120, HR 111, RR 18, T blank, P blank, O2 Sat 100% on 100% NRB mask.
3:37 p.m., BP 130/60, HR 107, RR 18, T blank, P 10, O2 Sat 100% on 100% NRB mask.
3:42 p.m., BP 102/57, HR 112, RR 18, T blank, P 10, O2 Sat 100% on 100% NRB mask.
3:47 p.m., BP 109/64, HR 104, RR 18, T blank, P 10, O2 Sat 100% on 100% NRB mask.

At 3:59 p.m., the History and Physical Exam completed by Emergency Department Nurse Practitioner 1 (EDNP 1) indicated Patient 1 was alert and oriented to person, place, time, and event. was afebrile (without fever), had a normal pulse, normal blood pressure, normal respiratory rate, normal oxygen saturation, and appeared non toxic (a non-diseased appearing patient) and pain free. The Doctor Notes completed by EDNP 1 further indicated Patient 1's lab data was reviewed and discussed with her primary care physician.

At 4:17 p.m., Patient 1's Re-Evaluation note completed by EDNP 1 reflected that the patient had stabilized.

At 4:48 p.m., the Nursing Assessment indicated Patient 1's heart rate was sinus tachycardia (faster than 100 beats per minute).

At 4:58 p.m., the Nursing Assessment:Severe Sepsis Screening Tool indicated again that Patient 1 was negative for sepsis with a heart rate greater than 90 beats per minute.

At 5:02 p.m., the Nursing Procedure: Cardiac Monitor note reflected Patient 1 was placed on a cardiac monitor and that Patient 1's HR was recorded higher than normal. There was no recording of Patient 1's cardiac rhythm strip found in her record.

At 6:07 p.m., the EMR's Doctor Notes reflected that Patient 1 was seen and examined in the ED by EDNP 1 at 4:05 p.m.. Medications were ordered by Emergency Department Medical Doctor (EDMD) 1, but the times did not reflect when they were actually ordered or administrated to Patient 1. The medications ordered were 2,000 milliliters (ml, a unit of measurement) bolus of normal saline intravenously (IV, a route to administer medication through the vein) to help with Patient 1's low blood pressure. Medications also included magnesium (a medication used to help prevent seizures in women with pre-eclampsia which is a disorder of pregnancy) 2 milligrams (mg, a unit of measurement) Intraosseous (IO, a process of injecting medications, fluids or blood products directly into the marrow of the bone for unstable patients), ondansetron (a medication used to help with nausea and vomiting) 4 mg IV, and lorazepam (a medication used for sedation) 2 mg IV to help stop any tremors or seizures. The notes further reflected that labs were drawn from Patient 1, but there were no labs ordered or lab results found in her record.

In an interview on 4/21/2022 at 3:25 p.m. with Emergency Department Nurse Supervisor (EDNS), EDNS confirmed that Patient 1 did not have any lab results in the EMR. EDNS further confirmed that the times documented in Patient 1's chart on 8/23/2020 at 3:59 p.m. and thereafter were entered after Patient 1 was transferred to the receiving hospital.

In an interview on 5/4/2022 at 2 p.m. with EDMD 1, EDMD 1 stated "I do not know how to back time. It can be very confusing to us sometimes."

A review Patient 1's American Medical Response (AMR) - San Joaquin Patient Care Report indicated that Patient 1 left Dameron hospital's ED at 3:57 p.m. to another hospital with a continued elevated heart rate at 118 beats per minute (bpm), a BP of 141/112, and a RR of 20. The record further indicated at 4 p.m. a HR of 93 bpm, a BP of 128/98,and a RR of 18.

In an interview on 4/21/2022 at 3:30 p.m. with EDNS, she stated that an ESI of 1 would indicate that the patient would need to be seen immediately for assessment and treatment purposes. She confirmed that Patient 1 was appropriately assessed as an ESI of 1 in the EMR.

A review of the hospital policy titled "Triage Emergency Severity Index (ESI) Level I to V," last revised 8/31/2017, indicated the purpose of an ESI level was "To determine patient acuity, prioritize the order in which patients are seen, and to determine the resources that will be needed to care for the patient." The policy indicated patients requiring life saving interventions are categorized as an ESI level 1, and the triage nurse (the nurse assessing the patient) will ask several questions to determine whether the patient requires an immediate lifesaving intervention and non-lifesaving interventions. Lifesaving interventions included significant IV fluid resuscitation. Non-lifesaving interventions included cardiac monitoring, diagnostic tests, an EKG (a recording of the hearts electrical activity), and labs.

During a concurrent interview and record review of the hospital's document titled "Evaluation for Severe Sepsis Screening Tool," dated 2020, on 4/22/2022 at 10 a.m. with the Emergency Department Nurse Director (EDND), EDND stated that according to this tool she would make sure that she had a full set of vital signs for the patient and some lab work. She further stated she would need to wait for the patient's lab results "to come back to check if the patient was septic." She further stated that if the patient's labs ruled them in as a septic patient according to the tool, the next step would be to obtain more labs and give appropriate treatment according to the tool. The tool indicated 2 questions to answer in order to screen patients for sepsis. The first question was whether the patient's history was suggestive of a new infection, and the second question was whether 2 of the following signs and symptoms of infection were present and new to the patient: T over 38.3 'C, T under 36 'C, altered mental status, low blood sugar level, heart rate above 90 bpm, White Blood Cell (WBC, cells of the immune system that protect the body against infections) count over 12,000 cells per microliter (cells/mm3, a unit of measurement), WBC count under 4,000 cells/mm3, or a rapid respiratory rate above 20 breaths per minute. If both questions are yes, then the suspicion of sepsis would be present and further labs and diagnostic tests would be ordered to rule out severe sepsis (sepsis with one or more body organ is damaged) and/or septic shock (a life-threatening condition due to a widespread infection causing organ failure and dangerously low blood pressure).

A review of the hospital's policy titled "Sepsis Identification and Management, Adult," last revised 2/2/2018, indicated that sepsis is a challenging disease to overcome, the progression of sepsis to severe sepsis and septic shock is devastating, which can yield a mortality rate of 25-50%. The policy further indicated that all patients during the admission process of the ED would be assessed and screened for sepsis. The policy indicated the key guidelines with determining sepsis includes whether 2 of the following sign and symptoms are both present and new to the patient, along with known or suspected new infection: a temperature above 38.3 'C, a heart rate greater than 90 bpm, a respiratory rate greater than 20, WBC count greater than 12,000 cells/mm3 or less than 4,000 cells/mm3 or greater than 10% bands (immature cells used to diagnose sepsis), altered mental status, or blood sugar lower than 140 milligrams per deciliter (mg/dL, a unit of measurement). If the patient has 2 of these signs and symptoms, then the nurse will immediately notify the physician, call a sepsis alert, draw a sepsis panel, and initiate a 3 hour bundle (actions that are taken within the first 3 hours of resuscitation after a positive screen for severe sepsis). "Once initial lab results are available, a secondary assessment should be completed by bedside nurse in order to identify additional signs of sepsis/severe sepsis or septic shock." The policy further indicated that if the patient was determined to have severe sepsis/septic shock by the physician, the 3 hour bundle would have been initiated and completed and a 6 hour bundle (actions that are taken within the first 6 hours of resuscitation after a positive screen for severe sepsis) would be initiated.

A review of The International Journal of Reproduction, Contraception, Obstetrics and Gynecology research article titled "Study of Causes and Complications of Intra Uterine Fetal Death [IUFD, death of an infant before being born]," dated 9/19/2014, reflected a study that was carried out over a period of 3 months (April 2014- June 2014) in a specialty hospital. Inclusion criteria was that all IUFD were over 20 weeks of gestation (time period in the womb). Out of 1,850 total births during the study period, 80 IUFD occurred. The second most common complication associated with IUFD was sepsis in 8 of the births (10%),

2. According to Patient 2's EMR, the Doctor Notes reflected Patient 2 was found in a private car in the front passenger seat between Patient 1's legs on 8/23/2020 at 2:03 p.m.. The record indicated Patient 2 was pulseless, cyanotic (blue skin color), and apneic (not breathing). Cardiopulmonary Resuscitation (CPR) was initiated on Patient 2.

A review of Patient 2's CPR Arrest Flowsheet, dated 8/23/2020 reflected the following:

At 1:55 p.m., Patient 2 was found with Patient 1 in a private car in the ED ambulance bay, and the ED initiated a code blue (a hospital emergency code used to describe the critical status of a patient).
At 2 p.m., cardiopulmonary resuscitation (CPR) was performed on Patient 2.
At 2:24 p.m., Naloxone (a medication used to treat narcotic overdoses) 0.7 ml was administered IV.
At 2:26 p.m.., Patient 2 was intubated (the insertion of a tube into a patient's airway) by EDMD.
At 2:34 p.m., Patient 2 was in sinus bradycardia (slower than 100 beats per minute) and Epinephrine (a medication used to treat cardiac arrest) 1mg/10ml 0.65 ml was administered IV.
At 2:35 p.m., Atropine (a medication used to treat heart rhythm problems) 1.3 ml was administered IV.
At 2:37 p.m., Umbilical IV was established and another Atropine 1.3 ml was administered IV.
At 2:40 p.m., Naloxone 0.7 ml was administered IV.
At 2:46 p.m., Patient 2 was in sinus bradycardia and Epinephrine 1mg/10ml IV 0.65 ml was administered IV.
At 2:49 p.m., Atropine 1.3 ml was administered IV.
At 2:57 p.m., Epinephrine 1mg/10ml 0.65 ml was administered IV.
At 2:58 p.m., Atropine 1.3 ml was administered IV.
At 3 p.m., Epinephrine 1mg/10ml 0.65 ml was administered IV.
At 3:03 p.m., Naloxone 0.7 ml was administrated IV.
At 3:17 p.m., Epinephrine 1mg/10ml 0.65 ml was administered IV.
At 3:29 p.m., Patient 2's heart rhythm had a pause with a narrow complex and sinus bradycardia with a rate of 46 bpm.
At 3:34 p.m.- 3:45 p.m., Patient 2's heart rhythm was asystole (when the heart stops beating) with a cessation of efforts, and a note indicated that all medications were based off of the Broselow Tape (The Broselow Pediatric Emergency Tape is a colorcoded tape measure that is used worldwide as a quick reference for pediatric emergencies which includes pre-calculated emergency medications, airway and equipment sizes, and starts at 3 kilograms (kg) as the lowest weight.).

A review of Patient 2's EMR indicated that Patient 2 weighed 0.45 kg and was 30.48 centimeters (cm) in length.

During an interview and concurrent record review of Patient 2's code sheets on 4/21/2022 at 11:30 a.m. with EDRN, he confirmed that Patient 2's code sheets contained the correct medication and that he was the nurse that drew up the medication. RN was unable to recall the concentration of the medications given, but confirmed that the Broselow tape was used for Patient 2. The record indicated that Patient 2's HR was only mentioned once during Patient 2's resuscitation, and Patient 2's temperature and cardiac rhythm strip were not recorded in the EMR.

During an interview on 4/21/2022 at 12:10 p.m. with On Call Anesthesiologist (ONA) 1 and 2, both confirmed that they were available on 8/23/2020 when Patient 2 arrived in the ED. OCA 2 stated that anesthesia was available and had the proper equipment in their carts to intubate a neonatal patient. He also stated that they were both were in the hospital until 7 p.m. for difficult intubations, and are usually called to do so in the ED about once a month.

During a record review and concurrent interview at 4/21/2022 at 3:20 p.m. with EDNS., Patient 2's EMR indicated that Patient 2 was "bagged and compressions were continued until intubation equipment became available." The record further indicated a 00 blade could not be found for intubation, so EDMD 1 used a 0 blade. The record indicated that Patient 2 became pink immediately after intubation and throughout the attempted resuscitation. The record indicated that a Broselow Tape was used for medications and doses. EDNS stated that intubation is not always immediate, but confirmed that EDMD did not have all of the necessary equipment to resuscitate Patient 2. She also stated that "It does not typically take 30 minutes to intubate."

During a concurrent interview with record review on 4/21/2022 at 4 p.m. with EDNP 2, EDNP 2 stated that she started CPR immediately when she went out to the car, because the newborn infant was cyanotic, pulseless, and in respiratory distress. She stated that Patient 1 and 2 were placed on a gurney with continued CPR on Patient 2 and brought into ED room 1. "[EDMD] cut the umbilical cord and the baby [Patient 2] was placed on the warmer." She further stated that she started an IV on Patient 2's hand and EDMD and her started an umbilical venous catheter (a tube to administer blood, medications, and fluid, and sometimes used to draw blood for labs). EDNP 2 stated that could not remember if any blood was drawn and sent to the lab, any EKG rhythm was seen or recorded, whether or not Patient 2 responded to the medications administered, or if there was a lack of equipment to intubate. She further stated that "If no equipment to intubate, then call anesthesia." She stated the Broselow Tape is not used for a neonatal (premature infant) resuscitation, but she stated that she has used a sheet that lists medications by the neonate's weight in grams and that this should be used for neonatal emergency medication administration. She confirmed that a Broselow Tape should not be used for a newborn neonate at 0.45 grams and that multiple doses of atropine could be toxic to a neonate by using the Broselow Tape.

A review of the hospital policy titled "Triage Emergency Severity Index (ESI) Level I to V indicated "Patients requiring life-saving interventions are categorized as a level 1. The policy further indicated that life-saving interventions include: intubation and medication administration of Naloxone and Atropine. The policy indicated non-lifesaving interventions that should be included with an ESI of 1 include: labs and a cardiac monitor.

A review of the hospital's EMTALA policy during 8/23/2020 titled "Transfer of Individual with or without an Emergency Medical Condition (EMC) EMTALA," last revised 8/1/2011, indicated, "If an individual has an EMC, the treating physician(s) and staff will provide further examination and necessary stabilizing treatment within the capabilities of the facility (including on-call physicians) and services available at the hospital." The policy further indicated that the treating physician will provide an appropriate medical treatment within the capabilities of the hospital's ED to minimize the risk of the individual's health.

In an interview on 5/4/2022 at 2 p.m. with EDMD 1, EDMD 1 verified that "Everything was documented in the chart [Patient 1 and 2's EMR] for the baby and mom."

Based on interview, medical record review, and document review, the Emergency Department (ED) failed to restrict the transfer for 1 of 26 sampled patients (Patient 1), when:

1. The ED had the capacity and capability to first stabilize and treat Patient 1's emergency medical condition (EMC) after the delivery of a premature newborn infant and for possible sepsis (a potentially life-threatening condition that occurs when the body's response to an infection damages its own tissues) and maternal sepsis (a severe bacterial infection usually in the womb which can occur during pregnancy or more commonly after childbirth) before she was transferred to another hospital where she required immediate intervention and treatment for septic shock (a life-threatening condition that occurs when a body's response to an infection damages its own tissues).

2. The receiving hospital's Labor and Delivery Medical Doctor (LDMD) was not notified and had not agreed to accept Patient 1 at the time of the transfer.

3. The receiving hospital did not receive Patient 1's medical record at the time of transfer.

This failure resulted in delay of treatment and stabilization of an immediate emergency medical condition (EMC) for Patient 1.

Findings:

1. A review of Patient 1's emergency department's (ED) electronic medical record (EMR), dated 8/23/2020 reflected the following timeline:

At 2:03 p.m., the Doctor Notes reflected Patient 1 was 28 weeks pregnant and had delivered Patient 2 in the front passenger seat of a private car in the ED ambulance bay. Patient 1 and Patient 2 were brought into the ED together on a gurney and placed in room 1.

At 2:15 p.m., the ED Registration Record reflected Patient 1 was admitted to the ED.

At 2:34 p.m., Patient 1 was triaged with an Emergency Screening Index (ESI, a tool to prioritize when a patient is seen and the resources needed to care for the patient with a scale of 1 to 5, level 1 being the most severe) of 1. Her Symptomatic Inflammatory Response Syndrome (SIRS, an exaggerated defense response of the body to an infection)/Sepsis (a potentially life-threatening condition that occurs when the body's response to an infection damages its own tissues) Screen (a tool used to screen patients for sepsis) was negative.

At 2:36 p.m., Patient 1's record indicated the Emergency Department Unit Clerk (EDUC) called the Labor and Delivery (L & D) Unit at the receiving hospital and "told" the receiving hospital that they are "going to transfer mother and baby ...the mother will go to L & D".

At 3:29 p.m., Patient 1's record indicated EDUC informed emergency department nurse practitioner (EDNP 1), the ambulance was coming to pick-up Patient 1 for transfer to the receiving hospital. The charting by EDMD 1 indicated "Physician Certification Statement Medical Necessity for Non-Emergency Ambulance Transportation" form was completed for the ambulance service by EDMD 1. The form indicated, Patient 1 was to be transferred because "services not available OB/GYN [Women's health and pregnancy doctor], L& D". The form did not indicate Patient 1 ' s emergency medical condition was stabilized. The form did not indicate that Patient 1 received an evaluation after receiving medication and treatment and symptoms of "tremors and seizures."

At 2:56 p.m., the Emergency Flow Sheet Record reflected Patient 1's first set of vital signs which included: blood pressure (BP, normal range is between 90/60 millimeters of mercury (mm HG, a unit of measurement) to 120/80 mm Hg) 107/49, heart rate (HR, normal range is between 60 to 100 beats per minute) 110, respiratory rate (RR, normal range is between 12 to 20 breaths per minute) 16, temperature (T) blank, pain (P, pain level between 1-10, and 10 being the highest) 10, and oxygen saturation (O2 Sat, how much oxygen is carried in your bloodstream with a normal level between 95-100%) 100% on room air. The EMR further indicated the following vital signs for Patient 1:

3:06 p.m., BP 82/20, HR 111, RR 18, T blank, P 10, O2 Sat 100% on room air.
3:11 p.m., BP 103/66, HR 112, RR 18, T blank, P 10, O2 Sat 100% on room air.
3:16 p.m., BP 123/71, HR 85, RR 18, T blank, P 10, O2 Sat 100% on room air.
3:22 p.m., BP 132/63, HR 90, RR 18, T 26.8 Degree Celsius ('C, a measurement of temperature with a normal body temperature range between 36.1 to 37.2 'C), P 10, O2 Sat 100% on room air.
3:30 p.m., BP 220/110, HR 108, RR, T blank, P 10, O2 Sat 100% on 100% non-rebreather (NRB, a type of mask that allows high concentrations of oxygen) mask.
3:35 p.m., BP 250/120, HR 111, RR 18, T blank, P blank, O2 Sat 100% on 100% NRB mask.
3:37 p.m., BP 130/60, HR 107, RR 18, T blank, P 10, O2 Sat 100% on 100% NRB mask.
3:42 p.m., BP 102/57, HR 112, RR 18, T blank, P 10, O2 Sat 100% on 100% NRB mask.
3:47 p.m., BP 109/64, HR 104, RR 18, T blank, P 10, O2 Sat 100% on 100% NRB mask.

At 3:59 p.m., the History and Physical Exam completed by Emergency Department Nurse Practitioner 1 (EDNP 1) indicated Patient 1 was alert and oriented to person, place, time, and event. was afebrile (without fever), had a normal pulse, normal blood pressure, normal respiratory rate, normal oxygen saturation, and appeared non toxic (a non-diseased appearing patient) and pain free. The Doctor Notes completed by EDNP 1 further indicated Patient 1's lab data was reviewed and discussed with her primary care physician.

At 4:17 p.m., Patient 1's Re-Evaluation note completed by EDNP 1 reflected that the patient had stabilized.

At 4:48 p.m., the Nursing Assessment indicated Patient 1's heart rate was sinus tachycardia (faster than 100 beats per minute).

At 4:58 p.m., the Nursing Assessment:Severe Sepsis Screening Tool indicated again that Patient 1 was negative for sepsis with a heart rate greater than 90 beats per minute.

At 5:02 p.m., the Nursing Procedure: Cardiac Monitor note reflected Patient 1 was placed on a cardiac monitor and that Patient 1's HR was recorded higher than normal. There was no recording of Patient 1's cardiac rhythm strip found in her record.

At 6:07 p.m., the EMR's Doctor Notes reflected that Patient 1 was seen and examined in the ED by EDNP 1 at 4:05 p.m.. Medications were ordered by Emergency Department Medical Doctor (EDMD) 1, but the times did not reflect when they were actually ordered or administrated to Patient 1. The medications ordered were 2,000 milliliters (ml, a unit of measurement) bolus of normal saline intravenously (IV, a route to administer medication through the vein) to help with Patient 1's low blood pressure. Medications also included magnesium (a medication used to help prevent seizures in women with pre-eclampsia which is a disorder of pregnancy) 2 milligrams (mg, a unit of measurement) Intraosseous (IO, a process of injecting medications, fluids or blood products directly into the marrow of the bone for unstable patients), ondansetron (a medication used to help with nausea and vomiting) 4 mg IV, and lorazepam (a medication used for sedation) 2 mg IV to help stop any tremors or seizures. The notes further reflected that labs were drawn from Patient 1, but there were no labs ordered or lab results found in her record.

In an interview on 4/21/2022 at 3:25 p.m. with Emergency Department Nurse Supervisor (EDNS), EDNS confirmed that Patient 1 did not have any lab results in the EMR. EDNS further confirmed that the times documented in Patient 1's chart on 8/23/2020 at 3:59 p.m. and thereafter were entered after Patient 1 was transferred to the receiving hospital.

In an interview on 5/4/2022 at 2 p.m. with EDMD 1, EDMD 1 stated "I do not know how to back time. It can be very confusing to us sometimes."

A review Patient 1's American Medical Response (AMR) - San Joaquin Patient Care Report indicated that Patient 1 left the hospital's ED at 3:57 p.m. to the receiving hospital with a continued elevated heart rate at 118 beats per minute (bpm), a BP of 141/112, and a RR of 20. The record further indicated at 4 p.m. a HR of 93 bpm, a BP of 128/98, and a RR of 18.

In an interview on 4/21/2022 at 3:30 p.m. with EDNS, she stated that an ESI of 1 would indicate that the patient would need to be seen immediately for assessment and treatment purposes. She confirmed that Patient 1 was appropriately assessed as an ESI of 1 in the EMR.

A review of the hospital policy titled "Triage Emergency Severity Index (ESI) Level I to V," last revised 8/31/2017, indicated the purpose of an ESI level was "To determine patient acuity, prioritize the order in which patients are seen, and to determine the resources that will be needed to care for the patient." The policy indicated patients requiring life saving interventions are categorized as an ESI level 1, and the triage nurse (the nurse assessing the patient) will ask several questions to determine whether the patient requires an immediate lifesaving intervention and non-lifesaving interventions. Lifesaving interventions included significant IV fluid resuscitation. Non-lifesaving interventions included cardiac monitoring, diagnostic tests, an EKG (a recording of the hearts electrical activity), and labs.

During a concurrent interview and record review of the hospital's document titled "Evaluation for Severe Sepsis Screening Tool," dated 2020, on 4/22/2022 at 10 a.m. with the Emergency Department Nurse Director (EDND), EDND stated that according to this tool she would make sure that she had a full set of vital signs for the patient and some lab work. She further stated she would need to wait for the patient's lab results "to come back to check if the patient was septic." She further stated that if the patient's labs ruled them in as a septic patient according to the tool, the next step would be to obtain more labs and give appropriate treatment according to the tool. The tool indicated 2 questions to answer in order to screen patients for sepsis. The first question was whether the patient's history was suggestive of a new infection, and the second question was whether 2 of the following signs and symptoms of infection were present and new to the patient: T over 38.3 'C, T under 36 'C, altered mental status, low blood sugar level, heart rate above 90 bpm, White Blood Cell (WBC, cells of the immune system that protect the body against infections) count over 12,000 cells per microliter (cells/mm3, a unit of measurement), WBC count under 4,000 cells/mm3, or a rapid respiratory rate above 20 breaths per minute. If both questions are yes, then the suspicion of sepsis would be present and further labs and diagnostic tests would be ordered to rule out severe sepsis (sepsis with one or more body organ is damaged) and/or septic shock (a life-threatening condition due to a widespread infection causing organ failure and dangerously low blood pressure).

A review of the hospital's policy titled "Sepsis Identification and Management, Adult," last revised 2/2/2018, indicated that sepsis is a challenging disease to overcome, the progression of sepsis to severe sepsis and septic shock is devastating, which can yield a mortality rate of 25-50%. The policy further indicated that all patients during the admission process of the ED would be assessed and screened for sepsis. The policy indicated the key guidelines with determining sepsis includes whether 2 of the following sign and symptoms are both present and new to the patient, along with known or suspected new infection: a temperature above 38.3 'C, a heart rate greater than 90 bpm, a respiratory rate greater than 20, WBC count greater than 12,000 cells/mm3 or less than 4,000 cells/mm3 or greater than 10% bands (immature cells used to diagnose sepsis), altered mental status, or blood sugar lower than 140 milligrams per deciliter (mg/dL, a unit of measurement). If the patient has 2 of these signs and symptoms, then the nurse will immediately notify the physician, call a sepsis alert, draw a sepsis panel, and initiate a 3 hour bundle (actions that are taken within the first 3 hours of resuscitation after a positive screen for severe sepsis). "Once initial lab results are available, a secondary assessment should be completed by bedside nurse in order to identify additional signs of sepsis/severe sepsis or septic shock." The policy further indicated that if the patient was determined to have severe sepsis/septic shock by the physician, the 3 hour bundle would have been initiated and completed and a 6 hour bundle (actions that are taken within the first 6 hours of resuscitation after a positive screen for severe sepsis) would be initiated.

A review of The International Journal of Reproduction, Contraception, Obstetrics and Gynecology reasearch article titled "Study of Causes and Complications of Intra Uterine Fetal Death [IUFD, death of an infant before being born]," dated 9/19/2014, reflected a study that was carried out over a period of 3 months (April 2014- June 2014) in a specialty hospital. Inclusion criteria was that all IUFD were over 20 weeks of gestation (time period in the womb). Out of 1,850 total births during the study period, 80 IUFD occurred. The second most common complication associated with IUFD was sepsis in 8 of the births (10%),

A review of Patient 1's EMR by the receiving hospital titled "Physician Note," dated 8/23/2020 at 7:11 p.m., indicated Patient 1 was brought into the receiving hospital by ambulance and found to be "unstable and hypotensive."

An interview on 4/19/2022 at 11:45 a.m. with LDMD stated that she thought Patient 1 was not stable for transfer.

During a concurrent interview and record review of the receiving hospital's Patient 1's EMR on 4/25/2022 at 12:00 p.m. with LDMD, LDMD stated Patient 1 had very low blood pressure and tried to wake her up, but could not. LDMD stated Patient 1 was "not stable" and a "code blue" team was called to help. LDMD stated she had "no doubt" that Patient 1 had sepsis. LDMD further stated Patient 1 was in the Labor and Delivery for only a few minutes before transferring Patient 1 to the Intensive Care Unit (ICU).

A review of Patient 1's EMR by the receiving hospital titled "Rapid Response Team Documentation" reflected that a sepsis alert (a hospital alert requiring hospital staff to immediately treat sepsis) was initiated for Patient 1 on 8/23/2020 at 4:29 p.m. in the Labor and Delivery Unit. The report reflected the following:

At 4:29 p.m., HR 120, BP 80/46, RR 20, O2 Sat 100% on 2 liters (L, a unit of measurement) nasal canula (n/c, a tube that is inserted in the nose to delivery oxygen)
At 4:34 p.m., HR 116, BP 77/47, RR 20, O2 Sat 100% 2L n/c
At 4:44 p.m., HR 114, BP 86/49, RR 22, O2 Sat 92% 2L n/c
At 4:53 p.m., HR 112, BP 98/56, RR 22, O2 Sat 98% 2L n/c
At 5:03 p.m., HR 113, BP 100/62, RR 20, O2 Sat 98% 2L n/c

The report further reflected Patient 1 received antibiotics (medications to inhibit the growth of infections), a normal saline bolus of 1 L, and was transferred to a higher level of care for the treatment of sepsis.

An interview on 4/26/2022 at 12 p.m. with the receiving hospital's Intensivist Medical Doctor (IMD) stated that when Patient 1 arrived at the receiving hospital's Labor and Delivery Unit the nurses called a sepsis alert. He stated that Patient 1 was not in the system yet, because they were questioning where she had come from. He further stated, "There are a few things you never forget." He stated Patient 1 was lethargic (the state of having little energy) and had a low blood pressure (a blood pressure below 90/60 mm HG). He further stated Patient 1 was uncooperative and "thrashing around," and she had a fever. He stated "She looked septic," and he confirmed that she was admitted to the Intensive Care Unit (ICU) for a few days to treat Patient 1 for sepsis and stabilize.

During a concurrent interview and record review of Patient 1's Doctor Notes on 4/22/2022 at 11:58 a.m. with the Chief Medical Officer (CMO), CMO stated that EDMD 1 called him to discuss the transfer of Patent 1 after Patient 1 was transferred to the receiving hospital. The CMO stated that the receiving hospital and physician were "upset". The CMO further stated he could not recall the conversation and did not know why there was a "discrepancy" between EDMD 1's note of "transfer done emergently," need for "911 immediate transfer," and "non-urgent transfer". The CMO confirmed that "all staff" are to follow EMTALA policy and procedures.

A review of the hospital's EMTALA policy during 8/23/2020 titled "Transfer of Individual with or without an Emergency Medical Condition (EMC) EMTALA," last revised 8/1/2011, indicated, "If an individual has an EMC, the treating physician(s) and staff will provide further examination and necessary stabilizing treatment within the capabilities of the facility (including on-call physicians) and services available at the hospital." The policy indicated that the treating physician will provide an appropriate medical treatment within the capabilities of the hospital's ED to minimize the risk of the individual's health. The policy further indicated the meaning of stabilize, "With respect to an emergency condition, to either provide such medical treatment as may be necessary to assure, within reasonable medical probability, that no material deterioration of the condition is likely to result from or occur during the transfer of the individual from the Hospital...."

2. During an interview with the Director of Quality (DoC) on 3/3/2020 at 3 p.m., DoC stated that the Labor and Delivery charge nurse at the receiving hospital told Dameron's ED unit clerk that the receiving hospital would accept Patient 1. DoC stated the ED unit clerk set up the transfer for Patient 1 to transfer to the receiving hospital, and EDMD did not call the receiving physician for acceptance. DoC further stated that there was a big break in communication between EDMD, EDNP1, the ED unit clerk, and the receiving hospital's charge nurse.

An interview on 4/19/2022 at 11:45 a.m. with LDMD stated they had not spoken with EDMD 1.

During a concurrent interview and record review of Patient 1's EMR on 4/21/2020 at 3:45 p.m. with EDNS, EDNS confirmed that there was no documentation regarding a physician to physician notification for transfer of Patient 1. The record indicated EDMD 1 did not call the receiving obstetrician personally and thought EDNP 1 called. But, EDNP 1 did not call the receiving hospital's obstetrician, he called the receiving neoatologist for the possibility of Patient 2's transfer. The record further indicated EDMD 1 called the receiving obstetrician later, and she was upset. The chief medical officer was also notified.

A review of Patient 1's receiving hospital's EMR titled "Physician Note," dated 8/23/2020 at 7:11 p.m., indicated, "Dameron's ED transferred the patient [Patient 1] without a doctor-to-doctor call and acceptance. [EDMD] called later to apologize and acknowledge the violation."

A review of the hospital's policy titled "Acceptance/Interfacility Transfer Procedure," last revised 5/5/2016, indicated the sending physician will contact the appropriate physician for acceptance for the transfer and documented.

A review of the hospital policy titled "Transfer of Individual with or without an Emergency Medical Condition (EMC) EMTALA," last revised 8/1/2011, indicated the transfer of a patient with an unstable EMC follow mandated regulatory standards including the receiving hospital's agreement to accept the patient and provide appropriate medical treatment.

3. During a concurrent interview and record review on 4/21/2022 at 3:45 p.m. with EDNS, EDNS stated that she was unable to determine whether Patient 1's chart was sent with Patient 1 to the receiving hospital. The EDNS confirmed that most of Patient 1's medical information was documented after Patient 1 was transferred to the receiving hospital, which was 8/23/2020 at 4:03 p.m..

A review of Patient 1's EMR from the receiving hospital titled "Physician Note," dated 8/23/2020 at 7:11 p.m., indicated the receiving physician had very limited information regarding Patient 1 when brought in by ambulance.

During a concurrent interview and document review on 4/25/2022 at 12:00 p.m. of Patient 1's EMR from the receiving hospital and LDMD, LDMD stated that Patient 1 arrived in labor and delivery with no documentation and she did not know where Patient 1 came from.

A review of the hospital's policy titled "Transfer of Individual with or without an Emergency Medical Condition (EMC) EMTALA," last revised 8/1/2011, indicated the transfer of a patient with an unstable EMC follow mandated regulatory standards which includes the transferring unit will send to the receiving facility all medical records available at the time of transfer related to the emergency condition of the patient.

In an interview on 5/4/2022 at 2 p.m. with EDMD1, EDMD 1 stated that everything that was done for the mom was documented in the chart.