USA Health University Hospital

“NURSING SERVICES CFR(s): 482.23 The hospital must have an organized nursing service that provides 24-hour nursing services. The nursing services must be furnished or supervised by a registered nurse. This Condition is not met as evidenced by: 30952 Based on review of medical records (MR), facility policy and procedure, incident/events, the Seven Day Report Follow-up and Biological Product Deviation Report documentation, Blood Bank Utilization Committee minutes, corrective action plan follow up, nursing education documentation, and interviews, it was determined the facility failed to re-educate and train all nursing staff and personnel whose responsibilities included blood/blood product pick-up and transfusion following a transfusion event and failed to ensure staff followed the facility policy and procedure for blood /blood product pick-up and transfusion. This deficient practice affected five of ten medical records (MR) reviewed for patients who received transfusions, and included MR # 1, MR # 2, MR # 6, MR # 10, and MR # 3 and had the potential to negatively affect all patients treated at the facility who receive transfusions. Refer to Tag A 392 and Tag A 410 for findings.”

“STAFFING AND DELIVERY OF CARE CFR(s): 482.23(b) The nursing service must have adequate numbers of licensed registered nurses, licensed practical (vocational) nurses, and other personnel to provide nursing care to all patients as needed. There must be supervisory and staff personnel for each department or nursing unit to ensure, when needed, the immediate availability of a registered nurse for care of any patient. This Standard is not met as evidenced by: 30952 Based on review of facility policy, incident/events, medical records (MR), facility Seven Day Report Follow-up and Biological Product Deviation Report documentation, Blood Bank Utilization Committee minutes, corrective action plan follow up, and nursing education documentation, it was determined the hospital failed to re-educate and train all nursing staff and personnel whose responsibilities include blood/blood product pick-up, administration, patient monitoring, and transfusion documentation following a self-reported event which involved nursing staff. This affected MR # 1, one of ten transfusion records reviewed, and had the potential to negatively affect all patients treated at the facility who require transfusions. Findings include: Facility Policy: Issue of Blood and Blood Products to Nursing Units Policy ID: 14165787 Last Approved: 10/2023 B. Blood products may be picked up in the Blood Bank by any nursing or medical personnel presenting the completed Blood Bank Pick-up Slip.... C. Using the information on the Pick-Up Slip: 1. Blood Bank personnel will complete and/or check the following for blood components: ... f. Expiration Date of Unit(s)... 2. Blood Bank personnel and accepting medical personnel will then VERBALLY recheck and compare... 8. Expiration date and, if applicable, time Review of the facility Transfusion Medicine Incident Management log included documentation of a self-reported event that occurred 11/11/23 in which blood bank staff issued an expired unit of platelets and staff transfused the expired platelets. MR review revealed MR # 1 presented to the Emergency Department (ED) on 11/10/23 and was admitted 11/11/23 with diagnoses including Nausea and Vomiting. While in the ED, MR # 1 required a MTP (Massive Transfusion Protocol). MR # 1 was transferred from the ED to the Medical Intensive Care Unit (MICU) where the expired platelet unit was reported to have been transfused by MICU staff. There was no MR documentation the expired platelet unit was administered. Review of the facility Seven Day Report (no date) Corrective Action Plan revealed on 11/11/23 the ED Registered Nurse (RN) failed to identify during the blood bank check out/release procedure that the platelet unit was expired. Further review of the facility Seven Day Report, the Biological Product Deviation Report submitted 11/24/23, Laboratory (lab) Events dated November 2023, and Blood Bank Utilization Committee minutes dated 12/8/23, revealed documentation the hospital corrective actions and follow up included: 1. Re-training (in-service/re-education), and counseling staff (blood bank and nursing) involved in the incident. 2. New policies with standard operation additions. 3. Staff in-service across the healthcare system to ensure such incidents will not reoccur. 4. Change in procedure for removal of expired products from inventory prior to the expiration time. 5. Expired product removal compliance monitoring. 6. System wide education of staff regarding changes to the transfusion process once in place. 7. Expansion of nursing team didactics to update/refresh transfusion best practices during May 2024. Review of the facility staff training documentation provided revealed no evidence the hospital corrective actions completed included re-education/training of all personnel and nursing staff responsible for blood/blood product pick-up, transfusion, and documentation using Bridge Medical Transfusion Program and the Downtime procedures. An interview was conducted on 6/13/24 at 11:30 AM, with Employee Identifier (EI) # 1, Director, Clinical Compliance, and EI # 3, Performance Improvement Manager, who confirmed the facility corrective actions following the 11/11/23 transfusion self-reported event failed to include re-education/training for all personnel and nursing staff whose job responsibilities included transfusions. 42144”

“BLOOD TRANSFUSIONS AND IV MEDICATIONS CFR(s): Blood transfusions and intravenous medications must be administered in accordance with State law and approved medical staff policies and procedures. This Standard is not met as evidenced by: 30952 Based on review of medical records (MR), facility procedure and interviews, it was determined the facility failed to ensure nursing staff followed the hospital transfusion procedure. This affected MR # 1, MR # 2, MR # 6, MR # 10, MR # 3, five of ten records reviewed with transfusions and had the potential to negatively affect all patients who receive transfusions at the facility. Findings include: Facility Procedure: Transfusion Procedure Policy ID-15429272 Effective: 10/23 A. Before obtaining blood products, verify physician order...AND signed consent. B. Patient Identification...full name and unique Identification Number must be...provided on the transfusion tag. The person tagging the blood must assure good reproduction on all copies. C. Transfusions should be documented with the Bridge Transfusion Administration program, which supports patient safety thorough positive patient identification (PPID) at the bedside, with barcode technology. D. If Bridge is NOT used and the transfusion is performed with downtime procedures, A QUALIFIED INDIVIDUAL, ALONG WITH THE TRANSFUSIONIST, SHALL IDENTIFY THE RECIPIENT AND THE UNIT OF BLOOD TO BE ADMINISTERED. ...2. THE INFORMATION ON THE “TRANSFUSION REPORT” (TAG) ON THE BLOOD MUST BE CHECKED WITH THE PATIENT WRISTBAND UTILIZING VERBAL COMMUNICATION. 3. IF ALL INFORMATION IS CORRECT, BOTH INDIVIDUALS MUST SIGN THE TAG WHERE INDICATED... H. The time...the transfusion is started must be recorded in Bridge, or if transfusing with downtime procedure, on the “Transfusion Report”. ...1. The recipient must be carefully observed...for the first fifteen minutes of the transfusion. ...2. For whole blood, red cell components, and granulocyte transfusions, record temperature, blood pressure, pulse, and general appearance at five-minute intervals. 3. Most major transfusion reactions will become apparent in this time and early recognition avoids a catastrophic reaction. J... patients receiving continuous care during a transfusion episode...in an emergent situation...a notation, such as “see Anesthesia Record” or “Patient continuously monitored” will suffice for the observation documentation. ...L... The total volume infused must be recorded in mL (milliliter) in Bridge, or with downtime procedures...indicated on the Transfusion Report. M. The Transfusionist documents when the transfusion is discontinued...or if transfusing with downtime procedures, must sign the Transfusion Report. 1. MR # 1 presented to the Emergency Department (ED) on 11/10/23 at 8:46 PM with Nausea and Vomiting and was admitted to the Medical Intensive Care Unit (MICU) on 11/11/23 at 1:31 AM. Review of the Transfusion History document (not part of the patient medical record) revealed on 11/11/23 at 2:33 AM, product number W115123287002 platelets, 282 milliliters was transfused. Review of the History and Physical from the ED dated 11/11/23 at 3:33 AM revealed the patient had episodes of bright red emesis as well as large melanotic bowel movements and was upgraded to the MICU team for a higher level of care. During the transition of care to MICU, Massive Transfusion Protocol (MTP) was ordered, and he/she was given a total of five units of blood and four units of FFP (Fresh Frozen Plasma). Review of the facility Seven Day Report Case # (number) 24-017 and Electronic Biological Product Deviation Receipt Confirmation report number 866648 (not dated) revealed a MTP was initiated at 2:00 AM on 11/11/23 and the appropriate number of red cells, FFP and platelet units were selected and issued at 2:34 AM on 11/11/23. All units passed visible inspection by the lab personnel and the nurse, but the expiration date was missed. The selected platelet unit expired at 11:59 AM on 11/10/23. The unit was transfused at 3:45 AM on 11/11/23. Review of all Bridge Medical Transfusion Reports and nursing notes dated 11/10/23 to 11/18/23 revealed no documentation the platelets were checked by a qualified individual along with the Transfusionist at the beside and no documentation the Bridge system was utilized to document the transfusion of the platelets. Further review revealed there was no documentation the platelets identified by product number W113123287002 was transfused to MR # 1. An interview conducted on 6/12/24 at 3:20 PM with Employee Identifier (EI) # 1, Director of Clinical Compliance confirmed there was no documentation in the medical record that the platelets were transfused to MR # 1. 2. MR # 2 was admitted to the facility on 5/25/24 with diagnoses of Acute Myeloid Leukemia in Adult and Neutropenic Fever. Review of the Bridge Medical Transfusion Report dated 6/1/24 revealed a unit of platelets was started at 6:34 PM. There was no documentation of the time the transfusion ended, the volume transfused or if there was a reaction. Review of the Bridge Medical Transfusion Report dated 6/3/24 revealed a unit of platelets was transfused starting at 5:36 PM. There was no documentation of the time the transfusion ended, the volume transfused or if there was a reaction. Review of the Bridge Medical Transfusion Report dated 6/9/24 revealed a unit of platelets was transfused starting at 4:07 PM. There was no documentation of the time the transfusion ended, the volume transfused or if there was a reaction. An interview conducted on 6/13/24 at 2:30 PM with EI # 2, Director of Clinical Compliance-USA Children’s, and Women’s Hospital, confirmed staff failed to follow the facility transfusion procedure. 3. MR # 6 was admitted to the facility for observation on 11/10/24 with diagnoses including Antineutrophilic Cytoplasmic Antibody-Associated Vasculitis, and Anemia for a blood transfusion. Review of the Bridge Medical Transfusion Report revealed on 11/11/23 one unit red blood cells transfusion was started at 2:32 AM, and at 2:37 AM the temperature, blood pressure, and pulse (vital signs) were documented. Review of the transfusion vital signs documentation revealed the second five minute interval vital signs were documented at 2:54 AM, which was seventeen minutes later and not every five minutes for the first fifteen minutes of the transfusion. Further review of the transfusion vital signs documentation revealed the third five minute interval vital signs were documented at 5:28 AM at transfusion end, which was two hours thirty-four minutes later. An interview was conducted on 6/13/24 at 2:42 PM with EI # 2 who confirmed staff failed to record temperature, blood pressure, and pulse at five minute intervals for the first fifteen minutes of the transfusion per the hospital transfusion procedure. 4. MR # 10 was admitted to the facility 10/23/23 with a diagnosis of Sepsis. Record review revealed Adult Blood Product Administration orders dated 11/11/23 at 12:36 PM to administer one unit packed red cells. Review of the Bridge Medical Transfusion Report dated 11/11/23 revealed at 4:24 PM the transfusion was started, and vital signs were documented at 4:29 PM and at 4:34 PM. Further review of the 11/11/23 Transfusion Report revealed the third interval of five minute vital signs were documented at 5:56 PM, which was eighty-two minutes later. An interview was conducted on 6/13/24 at 2:58 PM with EI # 2, who confirmed staff failed to follow the facility transfusion procedure and document vital signs at five minute intervals for the first fifteen minutes of the transfusion. 5. MR # 3 was admitted to the facility on 6/11/24 for outpatient intrathecal chemotherapy administration with a diagnosis of Diffuse Large B Cell Lymphoma. Review of the physician/provider orders dated 6/11/24 included transfuse one unit of irradiated platelets. Review of the MR revealed no documentation the platelet transfusion was entered into Bridge Medical Transfusion Report. The platelet transfusion was documented on the Downtime procedure Transfusion Report. Further review of the Transfusion Report dated 6/11/24 at 12:00 PM revealed the amount transfused was left blank. There was no documentation of the amount transfused. An interview was conducted on 6/13/24 at 2:45 PM with EI # 2, who confirmed the Transfusion Report documentation failed to contain the amount infused in mL per the Downtime procedure. 42144”

“ADEQUACY OF LABORATORY SERVICES CFR(s): 482.27(a) The hospital must have laboratory services available, either directly or through a contractual agreement with a certified laboratory that meets the requirements of part 493 of this chapter. This Standard is not met as evidenced by: 42144 Based on hospital event/incident documentation, medical record (MR) review, and interviews, it was determined the hospital failed to ensure laboratory (lab) staff followed the facility policy when issuing blood and blood products to nursing/medical personnel. This affected one of one self-reported events including Medical Record (MR) # 1 and had the potential to negatively affect all patients treated at the facility who required blood/blood product transfusions. Findings include: Facility Policy: Issue of Blood and Blood Products to Nursing Units Policy ID: 14165787 Last Approved: 10/2023 ... B. Blood products may be picked up in the Blood Bank by any nursing or medical personnel presenting the completed Blood Bank Pick-up Slip... C. Using the information on the Pick-Up Slip: 1. Blood Bank personnel will complete and/or check the following for blood components: ... f. Expiration Date of Unit (s)... 2. Blood Bank personnel and accepting medical personnel will then verbally recheck and compare... 8. Expiration date and, if applicable, time... 1. MR # 1 presented to the Emergency Department (ED) on 11/10/23 at 8:46 PM with Nausea and Vomiting and was admitted to the Medical Intensive Care Unit (MICU) on 11/11/23 at 1:31 AM. Review of the facility Seven Day Report and the Electronic Biological Product Deviation Receipt Confirmation report number 866648 (not dated) revealed a Massive Transfusion Protocol (MTP) was initiated at 2:00 AM on 11/11/23 and the appropriate number of red cells, Fresh Frozen Plasma and platelet units were selected and issued to MR # 1 at 2:34 AM on 11/11/23. All units passed visible inspection by the lab and the nurse, but the expiration date was missed. The selected platelet unit expired at 11:59 AM on 11/10/23. The unit was transfused at 3:45 AM on 11/11/23. Review of the Transfusion History document (not part of the patient medical record) revealed on 11/11/23 at 2:33 AM, product number W115123287002 platelets, 282 milliliters was transfused. An interview was conducted on 6/12/24 at 3:10 PM, with Employee Identifier (EI) # 7, Medical Laboratory Technician. EI # 7 confirmed he/she failed to remove expired blood/products from inventory on 11/10/23 before midnight. EI # 7 confirmed he/she issued an expired platelet unit around 2:30 AM on 11/11/23 during an MTP. EI # 7 reported no override of the computer system was needed as the platelet was issued under emergency release. EI # 7 reported the read back procedure was completed but neither he/she or the ED Nurse “caught” the platelet unit was expired. EI # 7 confirmed he/she failed to follow facility policy for issuing blood and blood products on 11/11/23. An interview conducted on 6/13/24 at 8:05 AM with EI # 6, ED Registered Nurse, revealed he/she was one of two staff who retrieved the blood products from the bank. EI # 6 stated, “We did not read back what we picked up” from the blood bank. An interview conducted on 6/12/24 at 3:20 PM with EI # 1, Director of Clinical Compliance, confirmed blood bank personnel and the accepting medical personnel failed to follow the facility policy for issuing blood and blood products.”