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MEDICAL STAFF

Tag No.: A0338

Based on the review of hospital policies, Medical Staff Bylaws, patient records, and staff interviews, it has been determined that the hospital's medical staff failed to adhere to the hospital's bylaws as an infant received the incorrect amount of blood ordered for a double exchange transfusion (a procedure that removes toxic blood by replacing the baby's total blood volume twice with donor blood) in the Neonatal Intensive Care Unit (NICU) (A-0353).

NURSING SERVICES

Tag No.: A0385

Based on a review of hospital policies, patient records, and staff interviews, it has been determined that the hospital failed to ensure a licensed nurse adhered to its policies and procedures regarding the administration of blood during an exchange transfusion (a procedure that removes and replaces one's blood with donor blood) in the Neonatal Intensive Care Unit (NICU) (A-0398). Additionally, the nurse failed to verify the provider's order for a double exchange transfusion (a procedure that removes toxic blood by replacing the baby's total blood volume twice with donor blood) and failed to utilize the exchange transfusion document as required by hospital policy (A-0398). As a result, the infant received only half of the blood volume ordered by the physician (A-0398, A-0410).

MEDICAL STAFF BYLAWS

Tag No.: A0353

Based on the review of hospital policies, Medical Staff Bylaws, patient records, and staff interviews, it has been determined that the hospital's medical staff failed to adhere to the hospital's bylaws as an infant received the incorrect amount of blood ordered for a double exchange transfusion (a procedure that removes toxic blood by replacing the baby's total blood volume twice with donor blood) in the Neonatal Intensive Care Unit (NICU) for 1 of 3 patients reviewed (Patient ID #1).

Findings are as follows:

According to the hospital's policy titled "Blood Administration (NICU)", the nurse "should verify provider order".

Additionally, the policy titled, "NICU Exchange Transfusion", states that the "Provider determines a volume of blood to be removed and replaced every several minutes ...An entire cycle of removal of one aliquot [a portion of a larger whole] of blood and infusion of an equal volume of blood should occur over a 3 minute interval...Provider verbalizes 'in' and 'out' volumes" and the nurse "records all the volumes on the exchange transfusion document which comes in the exchange kit..."

According to the hospital's "Medical Staff Association Bylaws", "An Attending Physician shall be responsible ultimately for the medical care and treatment of each patient in the Hospital..."

Additionally, the bylaws state that "If any clinical caregiver has any reason to doubt or question the care provided to any patient...he or she shall call this to the attention of the supervisor, who in turn may refer the matter to the Chief Medical Officer and the Senior VP of Patient Care Services..."

Record review revealed that Patient ID #1 was ordered 510 milliliters of blood to be administered over 153 minutes.

The record indicated that during the exchange transfusion, the nurse (Employee A) failed to record the "in" and "out" blood volumes on the designated exchange transfusion document as required by hospital policy. Instead, Employee A recorded the volumes incorrectly on a blank sheet of paper. Employee A's documentation indicated that 225 milliliters of blood was removed from the patient while only 225 milliliters of blood were administered over a period of 95 minutes. This indicates that the patient should have been transfused with an additional 285 milliliters of blood per the the physician's order, and was not.

Record review of the double exchange transfusion procedure note authored by Nurse Practitioner (Employee C), revealed that a total of 225 milliliters were exchanged during the procedure. This procedure note was then cosigned by the overnight Attending Physician (Employee F) who stated that he had supervised the procedure as the "attending physician on call."

During a surveyor interview on 9/5/2025 at 9:54 AM with Employee C, she explained that she was asked to relieve Employee B who had been performing the exchange transfusion. She stated that she and Employee B completed a "time out" where they verified the patient, confirmed the amount of blood to be removed and replaced, and the time it was to be infused over. Employee C then stated that she had asked the nurse that was recording the procedure, Employee A, if they were on the second bag of blood, to which Employee A replied that they were not. Employee C then stated that she stopped because "something didn't sit right with me." She then questioned Employee A again, and she indicated at that time that the blood had been ordered incorrectly.

Employee C indicated that after the procedure was completed, she told the Fellow (Employee E) that they should have administered approximately 500 milliliters, but Employee E told her that what they administered was correct. Employee C stated that she did not question Employee E again because she is her "superior." Employee C then explained that she went to document the procedure in the medical record and again confirmed with Employee E that they had performed a double volume exchange transfusion, and Employee E again indicated that the correct amount of blood had been infused.

When asked if she had reviewed Employee A's documentation for the exchange transfusion, Employee C confirmed that she had not. Upon reviewing Employee A's documentation with Employee C, she immediately identified that the blood volumes were recorded incorrectly since it appeared that Employee A counted each volume "in" and each volume "out" individually when she should not have.

During a surveyor interview on 9/5/2025 at 11:28 AM with the Fellow (Employee E), she explained that she received report from Attending Physician (Employee D). Upon arriving at the patient's room, she observed Employee B performing the procedure and the nurse recording it. She stated that she did not speak to them because "they seemed to have a good handle on it." She also stated that at one point, Employee B took over for Employee C during the procedure, but she did not hear what was discussed during their time-out.

Employee E reported that when the nurse said the procedure was finished, she noticed "extra blood" but did not question it. She also indicated that during report, Employee D told her that they were performing a double exchange transfusion. However, she stated she was "under the impression it was a single exchange transfusion", but was unable to explain why.

When asked if she had reviewed the order to confirm the amount of blood to be administered to the patient, she stated that she had not. She also confirmed that she did not review Employee A's documentation for the procedure.

During a surveyor interview on 9/4/2025 at 2:40 PM with Employee D, he stated that he was present at the bedside when the exchange transfusion began and supervised Employee B during the initiation of the exchange transfusion. When asked if he had reviewed Employee A's documentation during the exchange transfusion, he confirmed that he had not. Upon reviewing Employee A's documentation with Employee D, he immediately identified that the volumes were recorded incorrectly since it appeared that Employee A counted each blood volume "in" and each volume "out" individually when she should not have.

During a surveyor interview on 9/5/2025 at 9:14 AM with Employee F, he stated that he supervised the procedure but was not present the entire time. Employee F acknowledged that he cosigned the procedure note but "did not pay attention to the 225" because no concerns were reported to him. Additionally, he acknowledged that he did not review the order to confirm that the amount of blood administered was what was ordered. When asked if he had reviewed Employee A's documentation when he supervised the exchange transfusion, he confirmed that he had not. Upon reviewing Employee A's documentation with Employee F, he immediately identified that the volumes were recorded incorrectly since it appeared that Employee A counted each volume "in" and each volume "out" individually when she should not have.

SUPERVISION OF CONTRACT STAFF

Tag No.: A0398

Based on a review of hospital policies, patient records, and staff interviews, it was determined that the hospital failed to ensure a licensed nurse adhered to its policies and procedures regarding the administration of blood during an exchange transfusions (a procedure that removes and replaces blood with donor blood) in the Neonatal Intensive Care Unit (NICU) for 1 of 3 patients reviewed (Patient ID #1). Specifically, the nurse failed to verify the provider's order for a double exchange transfusion (a procedure that removes and simultaneously replaces toxic blood from an infant with donor blood with twice their blood volume) and did not utilize the exchange transfusion document as required by hospital policy. As a result, the infant received approximately one half of the blood volume ordered by the physician.

Findings are as follows:

According to the hospital's policy titled "Blood Administration (NICU)", the nurse "should verify provider order".

Additionally, the policy titled, "NICU Exchange Transfusion", states that the "Provider determines a volume of blood to be removed and replaced every several minutes ...An entire cycle of removal of one aliquot [a portion of a larger whole] of blood and infusion of an equal volume of blood should occur over a 3 minute interval...Provider verbalizes 'in' and 'out' volumes" and the nurse "records all the volumes on the exchange transfusion document which comes in the exchange kit..."

Record review revealed that Patient ID #1 was ordered 510 milliliters of blood to be administered over 153 minutes.

The record indicated that during the exchange transfusion, the nurse (Employee A) failed to record the "in" and "out" blood volumes on the designated exchange transfusion document as required by hospital policy. Instead, Employee A recorded the volumes incorrectly on a blank sheet of paper. Employee A's documentation indicated that 225 milliliters of blood were removed from the patient while only 225 milliliters of blood were administered over a period of 95 minutes. This indicates that the patient should have been transfused with an additional 285 milliliters of blood per the the physician's order, and was not.

During a surveyor interview on 9/4/2025 at 2:10 PM with nurse (Employee A), she indicated that she reviewed the exchange transfusion order, but did not notice that the amount of blood transfused was not what the doctor had ordered. Additionally, Employee A acknowledged that she did not use the exchange transfusion document as required by hospital policy and instead made her own form that she used to document the procedure on.

During a surveyor interview on 9/5/2025 at 9:54 AM with Nurse Practitioner (Employee C), she explained that she was asked to relieve Employee B who had been performing the exchange transfusion. She stated she and Employee B completed a "time out" where they verified the patient, confirmed the amount of blood to be removed and replaced, and the time it was to be infused over. Employee C then stated that she asked the nurse recording the procedure, Employee A, if they were on the second bag of blood, to which Employee A replied that they were not. Employee C then stated that she stopped because "something didn't sit right with me." She then questioned Employee A again and Employee A indicated at that time that the blood had been ordered incorrectly.

Employee C indicated that after the procedure was completed, she told the Fellow (Employee E) that they should have given the patient approximately 500 milliliters, but Employee E told her that what they gave was correct. Employee C stated that she did not question Employee E again because she is her superior. Employee C then explained that she went to document the procedure in the medical record and again confirmed with Employee E that they had performed a double volume exchange transfusion, and Employee E again indicated they had infused the correct amount of blood.

During a record review of Employee A's documentation of the procedure with Employee C, Employee C immediately identified that the blood volumes were recorded incorrectly, as it appeared that Employee A counted each volume "in" and each volume "out" individually when she should not have.

During a surveyor interview on 9/4/2025 at 2:40 PM with the Attending Physician (Employee D), he stated that he was present at the bedside when the exchange transfusion began and supervised Employee B during the initiation of the exchange transfusion. This surveyor presented Employee A's recorded "in" and "out" blood volumes for the patient's exchange transfusion. Upon reviewing the documentation with Employee D, he immediately identified that the volumes were recorded incorrectly as it appeared that Employee A counted each blood volume "in" and each volume "out" individually when she should not have.

BLOOD TRANSFUSIONS AND IV MEDICATIONS

Tag No.: A0410

Based on a review of hospital policies, patient records, and staff interviews, it has been determined that the hospital failed to ensure that the correct amount of blood was administered to an infant during a double exchange transfusion (a procedure that removes toxic blood by replacing the baby's total blood volume twice with donor blood) in the Neonatal Intensive Care Unit (NICU), in accordance with hospital policy for 1 of 3 patients reviewed (Patient ID #1). As a result of this failure, the infant received approximately one half of the blood volume ordered by the physician.

Findings are as follows:

According to the hospital's policy titled "NICU Exchange Transfusion", a double exchange transfusion is defined as "A procedure to remove whole blood from an infant for the removal of toxic substances with the simultaneous replacement of an equal volume of whole blood lacking toxins. This procedure involves exchanging twice the infant's calculated blood volume."

Record review revealed that Patient ID #1 was ordered 510 milliliters of blood to be administered over 153 minutes.

The record indicated that during the exchange transfusion, 225 milliliters of blood were removed from the patient while only 225 milliliters of blood were administered over a period of 95 minutes. This indicates that the patient should have been transfused with an additional 285 milliliters of blood per the the physician's order, and was not.

During a surveyor interview on 9/4/2025 at 2:10 PM with the nurse (Employee A), she indicated that she reviewed the exchange transfusion order, but failed to identify that the amount of blood transfused was not what follow the doctor had ordered.

During a surveyor interview on 9/4/2025 at 2:40 PM with the Attending Physician (Employee D), he acknowledged that the patient received half of the intended amount of blood.