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Based on record review, interview and policy review, the facility failed to ensure the physician was notified when a patient's heart rate remained above normal. This affected Patient #1.

See A395

Based on record review, interview and policy review, the facility failed to provide balanced blood component therapy, in accordance with acceptable standards of practice and the hospital's policies in place at the time. This affected two (Patients #2 and #7) level II obstetric patients. The hospital averages approximately 1000 deliveries annually.
See A1103

Based on record review, interview and policy review, the facility failed to ensure the physician was notified when a patient's heart rate remained above normal. This affected Patient #1.

Findings include:

Review of the medical record of Patient #1, a Gravida 2 Para 0 at 39 weeks gestation, revealed the patient was admitted to Labor and Delivery on 11/21/24 at 12:07 AM for a scheduled induction of labor due to a diagnosis of preeclampsia without severe features. Two doses of Cytotec were administered to induce the patient's labor. By 7:49 PM, the labor flow sheet revealed the patient's heart rate was elevated at 122 beats per minute. The patient's heart rate remained elevated and at 8:25 PM, it was 132 beats per minute. At 8:45 PM, the labor flow sheet revealed a Category II fetal heart tracing as late decelerations in the fetal heart rate were occurring. The patient's heart rate remained elevated at 123 beats per minute at this time.

On 11/21/24 at 9:45 PM, the fetal heart baseline was elevated at 160 beats per minute. At 10:22 PM, the patient was four centimeters dilated and at 10:31 PM, the patient's heart rate remained elevated at 134 beats per minute. The elevated heart rate continued throughout the night and into the morning of 11/22/24. On 11/22/24 at 2:46 AM, the patient's heart rate remained elevated at 139 beats per minute. At 4:31 AM, the patient's heart rage was climbing at 149 beats per minute. At 5:16 AM, the patient's heart rate was very elevated at 158 beats per minute. There was no documentation the obstetric physician was notified of the increase in the patient's heart rate at any time from 11/21/24 at 7:49 PM until 11/22/24 at 5:16 AM.

On 11/22/24, the decision was made to perform an unscheduled cesarean section due to non-reassuring fetal heart tones. The Delivery Summary revealed the infant was delivered on 11/22/24 at 5:41 AM. The Operative Note revealed that the patient was diagnosed with intrapartum hemorrhage as the estimated blood loss was 1265 mL. Although a massive transfusion protocol was not activated, the patient was medicated with Hemabate, TXA, and rectal Cytotec.

During an interview on 03/04/25 at 2:40 PM, the Labor and Delivery Nurse Manager, Staff B, confirmed that Patient #1 maintained a heart rate greater than 120 beats per minute for an entire shift on 11/21/24 and the medical record lacked documentation an obstetric provider was notified.

The facility policy titled "Laboring Patient Care", effective April 2019, stated registered nurses are instructed to notify an OB provider in the event a patient has a pulse greater than 120 beats per minute upon repeat evaluation.

Based on record review, interview and policy review, the facility failed to provide balanced blood component therapy, in accordance with acceptable standards of practice and the hospital's policies in place at the time. This affected two (Patients #2 and #7) level II obstetric patients. The hospital averages approximately 1000 deliveries annually.

Findings include:

1. Record review revealed Patient #2, Gravida 2 Para 1 at 37.4 weeks gestation, was admitted on 12/09/24 at 2:04 PM after serial blood pressures were elevated and a maternal fetal medicine physician recommended the patient's labor be induced. After the induction of labor was initiated, the patient experienced non-reassuring fetal heart tones and an emergency cesarean section was performed. The Delivery Summary revealed the infant was delivered at 9:37 AM on 12/10/24. The estimated blood loss was 1055 mL. The patient recovered and was transported to the Mother Infant unit at 12:50 PM.

On 12/10/24 at 6:15 PM, through a Spanish interpreter, the patient complained of severe upper abdominal pain, feeling sick, sweaty, and dizzy. At 6:19 PM, the patient was passing clots vaginally. Obstetric resident physicians were at the bedside of the patient at 6:21 PM. At 6:24 PM, the patient was hypotensive with a blood pressure of 75/48 millimeters of mercury (mmHg). The attending obstetric physician was at the bedside of the patient at 6:29 PM and a massive transfusion protocol (MTP) was activated at 6:40 PM.

Review of the MTP blood bank notes revealed the first cooler, released at 6:45 PM, contained four units of packed red blood cells and two units of fresh frozen plasma.

At 6:50 PM, the patient was transported to the Operating Room. Platelets were not stored in the blood bank, therefore, a STAT order for platelets was placed by a blood bank staff member at 6:55 PM. The patient underwent an exploratory laparotomy and was actively bleeding. An emergent hysterectomy was performed. The second cooler, released at 7:20 PM, contained four units of packed red blood cells only as the fresh frozen plasma continued to thaw. Two units of fresh frozen plasma was released 10 minutes later, at 7:30 PM. The third cooler contained four units of packed red blood cells only and was released at 7:41 PM. A blood bank note stated that staff rotated two to four units of packed red blood cells and thawed plasma every 10-15 minutes. During the procedure, the patient went into pulseless ventricular tachycardia arrest and a code blue was initiated. She underwent multiple rounds of cardiopulmonary resuscitation (CPR). During this time, general surgery was consulted for assistance, a left thoracotomy (a surgical procedure that involves making an incision in the left chest wall to access the organs and structures within the thoracic cavity) was performed. In all, 16 rounds of epinephrine were administered, 26 units of packed red blood cells and 10 units of fresh frozen plasma were transfused. The ordered unit of pooled platelets did not arrive to hospital until 8:20 PM. The platelets were transfused at 8:23 PM. Despite these aggressive resuscitative measures, the patient died at 8:40 PM.


2. Record review revealed Patient #7, Gravida 1 Para 0 at 41.3 weeks gestation, presented to Obstetric Triage on 10/29/23 at 5:36 PM with complaints of contractions. With the use of a Spanish interpreter, the patient stated contractions had become more painful. The decision was made to perform a cesarean section due to non-reassuring fetal heart tones and patient request.

The Delivery Summary revealed the infant was delivered at 1:21 AM. Brisk bleeding from the incision was noted. Brisk atony (lack of normal tone or tension in muscles) was also noted. The estimated blood loss was 4250 milliliters (ml). MTP was activated at 1:43 AM. There were no platelets available in the blood bank. A blood bank note revealed the first cooler containing four units of packed red blood cells was released at 1:50 AM. Two units of fresh frozen plasma was released at 1:58 AM. The second cooler containing four units of packed red blood cells was released at 2:16 AM. A unit of pooled platelets was not ordered by a blood bank staff member until 2:26 AM. At 2:42 AM, the blood bank released four units of packed red blood cells and two units of fresh frozen plasma.

Review of a progress note at 2:43 AM by the Certified Registered Nurse Anesthetist (CRNA) he and his attending anesthesiologist noticed a sudden drop in the ETCO2 (end-tidal carbon dioxide) and the attending anesthesiologist was unable to palpate a pulse. A code blue was called and chest compressions were initiated. As compressions were initiated, frank red blood was coming from the endotracheal tube. Despite continued aggressive resuscitative measures, compressions were stopped, the code was terminated and the patient was pronounced dead at 3:52 AM.

According to the Operative Report, 12 units of packed red blood cells, and three units of fresh frozen plasma were transfused, however, no platelets were infused as the platelets did not arrive until 4:07 AM, 15 minutes after the patient was pronounced dead.

Review of a letter titled "Mount Carmel Health System Blood Bank System Update", undated stated due to the system's increase in wastage of platelet products, fiscal year total in 2019 $63,914 and fiscal year total in 2020 $153,452, facility Blood Bank needed to reduce the amount of stock platelets kept on site 24/7. With this update, it was recognized that the request for platelets during surgeries will be accepted. It will be up to each site to monitor these requests and make sure that one platelet is kept in-house until after the patient's surgery. As of 11/03/20, Mount Carmel Grove city would not longer keep stock platelets.

During an interview on 03/17/25 at 4:45 PM, Blood Bank technician, Staff E, stated there is typically one technician working in the Blood Bank 24/7. She stated in the event of an activation of MTP, if there is a technician in the lab that is trained in the blood bank, he/she may step in to assist. She stated that the blood bank keeps two units of thawed plasma as it takes 30-35 minutes to thaw fresh frozen plasma. Staff E confirmed there were currently no platelets in the blood bank. She further stated when an MTP is activated, the technician working in the Blood Bank electronically orders a unit of platelets STAT from the American Red Cross. Staff E stated it typically takes one hour to receive the platelets but can take longer depending on traffic.

During an interview on 03/19/25 at 11:00 AM, the System Lab Director, Staff D stated platelets aren't kept in the blood bank and have to be ordered at the American Red Cross. Staff D stated that platelets used to be available in the blood bank but the decision was made to discontinue this practice due to the cost.

During an interview on 03/18/25 at 1:49 PM and on 03/20/25 at 8:19 AM, the anesthesiologist, Staff G stated that Patient #2 was a complicated case. He stated that during an activation of MTP, blood products should be administered in a one to one to one ratio of packed red blood cells, fresh frozen plasma, and platelets to ensure balanced resuscitation and prevent dilutional coagulopathy (occurs when blood volume is rapidly replaced with fluids that lack clotting factors). This ratio mimics the composition of whole blood. Platelets are essential for blood clotting and are often depleted in patients that are hemorrhaging. Staff G stated a the one to one to one ratio is ideal. He stated that there were some limitations of platelets during the MTP of Patient #2. Staff G stated that he could think of numerous clinical scenarios where the presence of platelets was the difference between life and death. He stated that if he had to vote, he would vote to keep platelets stored in the blood bank 24/7.

During an interview on 03/18/25 at 1:11 PM, Rapid Response Registered Nurse, Staff H, stated that she ran the Belmont rapid infuser during the activation of MTP and subsequent code of Patient #2. She stated that Patient #2 was losing blood really fast. A ratio of one to one to one is ideal to get as close to whole blood as possible. Platelets are essential for blood clotting. She stated that without administration of platelets as a clotting factor, the patient's blood was pouring out as fast as they could transfuse it. Staff H stated that they're at the mercy of the American Red Cross when platelets aren't stored in the blood bank 24/7.

During an interview on 03/20/25 at 4:45 PM, the Regional Director of Regulatory and Accreditation Services, Staff A stated the standard of care calls for a one to one to one ratio of packed red blood cells, fresh frozen plasma, and platelets, mimicking whole blood during activation of MTP. And currently, there are no platelets stored in the blood bank. It was confirmed that the STAT order for platelets for Patient #7 wasn't placed until 43 minutes after activation of MTP when the facility policy requires for platelets to be ordered upon activation of MTP. It was further confirmed that the facility discontinued keeping stock platelets due to the cost.

In a scholarly article titled "The Society for Academic Specialists in General Obstetrics and Gynecology" dated 11/05/24, stated obstetric patients that experience severe hemorrhage may necessitate massive transfusion, defined as transfusion of 4 or more units of packed red blood cells within one hour with ongoing bleeding, transfusion of 10 or more units of packed red blood cells within 24 hours, or replacement of the patient's entire blood volume. Once these criteria are met, fixed ratios of blood products are transfused in a 1:1:1 ratio of packed red blood cells, fresh frozen plasma, and platelets, mimicking whole blood. Blood banks store and release platelets in pooled units equivalent to 6 individual units.

The facility policy titled "Massive Transfusion Protocol Management", issued April 2019, stated the massive transfusion system standard facilitates the rapid availability and delivery of blood and blood products when a massive hemorrhage situation occurs. The goal of massive blood transfusion is to restore blood volume and components rapidly during a massive hemorrhage to maintain hemodynamic stability, homeostasis, oxygen-carrying capacity, oncotic pressure, and chemical balance. The MTP is designed to ensure continuous and timely access to blood components for use in resuscitating patients with massive traumatic hemorrhage. Patients who experience massive hemorrhage will develop severe hematological derangements if prompt blood product replacement is not delivered. Facility staff is instructed that the first container/cooler should contain four units of packed red blood cells, two units of fresh frozen plasma, and no platelets. The second container/cooler should contain four units of packed red blood cells, 2 units of fresh frozen plasma, and one unit of pooled platelets. Subsequent containers/coolers will be provided as products become available. The policy further states platelet products will be ordered STAT from the American Red Cross upon activation of the MTP.