HospitalInspections.org

Based on document review and interview, it was determined that the hospital failed to ensure compliance with 42 CFR 482.23, Nursing Services.

Findings include:

1. The hospital failed to ensure patients receiving blood transfusions were cared for in accordance with accepted standards of nursing practice and hospital policy. (A-410)

A. Based on document review and interview for 1 (Pt#1) of 4 patients reviewed for Emergency Release Protocol (a hospital procedure to quickly provide uncrossmatched blood to patients with life-threatening bleeding when there isn't enough time for compatibility testing), the Hospital failed to ensure patient's receiving blood transfusions were cared for in accordance with accepted standards of nursing practice and hospital policy by failing to inspect the unit of blood and verify right blood product with right patient prior to administration. Staff are unaware of the difference between Emergency Release and Mass Transfusion Protocol. This failure included a unit of packed red blood cells that was labeled for (Pt#2) and was administered to (Pt#1). This failure is likely to cause complications up to and including death for all patients receiving emergency blood products due to the failure to verify the right blood product with the right patient.

Findings include:

1. Pt#1's record was reviewed throughout the survey. Pt#1 is a 29-year-old male who presented to the ED on 7/18/25 at 2:46 PM with a chief complaint of "Dizziness after outpatient procedure ... Past Surgical History: Procedure: Nephrostomy (tube that lets urine drain from kidney through an opening in the skin on the back) Right 7/15/2025. Cystoscopy (procedure to view the inside of the bladder and urethra) Bilateral 7/10/25."

- ED Triage Notes by ED RN (E#19) dictated on 7/18/25 at 3:01 PM stated, "(Pt#1) here today in OPS (Outpatient Surgery) for bx (biopsy). (Pt#1) got up after procedure and felt dizzy and lightheaded. Staff called Code Green (emergency situation requiring immediate action)... Patient sent to CT and to ED." CT Impression dated 07/18/25 at 2:39 PM stated, "1. Interval increase in size of large right retroperitoneal hematoma (abnormal collection of blood outside a vessel) with active arterial extravasation (leakage of blood, lymph or other fluid ... from a blood vessel or tube into the tissue around it) ...."

- Pt#1's CBC (complete blood count) dated 07/18/25 at 3:18 PM documents a hemoglobin of 12 (reference range 13-17.5) and a hematocrit of 36.7% (percent) (reference range 38.9-50.3). Vitals at 3:50 PM note a heart rate of 83 (normal 60-100), Respiratory rate of 14 (normal 12-20) and Blood pressure 130/94 (within normal range),

- Pt#1's ED timeline documented an order for 1 unit of PRBCs (Packed Red Blood Cells) at 3:20 PM. An order dated 07/18/25 at 3:33 PM indicated, "Transfusion Administration - Attestation for Emergency or Massive Transfusion" (attestation is the physician order to administer blood transfusion as Emergency or Massive Transfusion). The "Order Requisition" for 7/18/25 at 3:34 PM indicated, "... Process Instructions: MTP/Emergent Release Attestation: I declare that because of the medical condition of the above identified patient, I require the release from the Blood Bank of blood and/or blood components.... Order Questions: ... Transfusion indications: Hemorrhagic shock/Life-threatening bleeding... Release Time Fri [Friday] Jul 18, 2025 3:30 PM..."

- ED Notes by ED RN (E#20) on 7/18/25 at 4:00 PM stated, "Uncrossed match 1 unit of blood administered by gravity. Paper chart placed in pt chart."

2. The "Emergency Dispense of Blood Products" policy dated 09/11/24 was reviewed. It noted, " The policy indicated, "All blood and blood products released under emergency conditions must have one of the following: a) Attestation for Emergency or Massive Transfusion (Epid order) order OR b) Signed Physician Acknowledgement and Consent for Blood Component Transfusion in Emergent or Special Siutations form.... C. Completion of Physicican Acknowledgment and Consent for Blood Component Transfusion in Emergent or Special Situations form. Procedure: 1. Record the patient's name, MRN [Medical Record Number] and date of birth (DOB), if known, on the form in the areas indicated. 2. Indicate the emergency by checking the appropriate box. 3. Transport the completed form with the blood product(s).... 6. Leave the top (white) copy with the patient care team to be placed in the chart and request the bottom (yellow) copy be returned to the blood bank...."... Situations that may require emergency issue of blood bank products include but are not limited to: a) Urgent need for blood or blood products prior to collection of a specimen for testing ... 14. Units issued as emergency release should not be sent with downtime transfusion documents [paper record for blood transfusion which includes nursing confirmation of verifying the blood product and the patient information as well documents the vitals - before, during and after the administration of blood]. These units must be documented in Epic [electronic health record system] ..."

3. The "Massive Transfustion Protocol (MTP) - Adult" dated march 2016 was reviewed. The policy noted, "... Policy: A. Criteria for activation of the massive transfusion protocol by the physician/surgeon/anesthesiologist: Patients at risk for uncontrolled hemorrhage .... B. The physician will oder the Massive Transfusion Protocol in Epic... D. ... The MTP ordering unit will send a team member to the blood bank to retrieve Pack #1. Note: The person retrieving the blood can be any employee with a name badge and patient information such as a sticker or a face sheet [patient information sheet that gives name, date of birth and other identifying factors]... E. Until the group, type and Screen specimen is received and completed, uncrossmatched Group O or type compatible blood product is issued... Procedure: ... E. Transufse blood products according to nursing policies Blood Administration: BJC East... G. Use Downtime Forms sent with the blood products..."

4. SEMS (Safety Event Management System) event (ED - Emergency Department) was reviewed on 9/30/25 and stated, "MTP (Massive Transfusion Protocol) order was placed for (Pt#1). (ED RN - E#18) took patient label to the lab and retrieved MTP box from blood bank which box was labeled with patient information. O+ (O positive)/uncrossmatched unit of blood (blood that is transfused without first undergoing a procedure to ensure compatibility between donor and recipient blood) was started. This RN (E#20) answered phone call from blood bank stating, 'there was an issue with the blood' and asked if infusion was started... This RN (E#20) went to check the unit of blood that was infusing. It was labeled O+/uncrossmatched but was labeled with the incorrect patient on the back of the unit of blood. This RN (E#20) stopped the blood and called blood bank and requested on what to do. Lab tech (E#23) stated, 'I need to call my supervisor'. This RN (E#20) made tech aware of the emergent need for blood. ED RN, (E#18) again went to blood bank with the patient label and retrieved another box of MTP which included the one unit again. The box and unit of blood was now labeled correctly with the right patient. The previous unit was placed back in the original box and the new unit was started. This RN (E#20) to return the incorrect unit of blood-to-blood bank ..."

Pt #1's record lacked documentation of the event where Pt #1 was administered the blood labeled for Pt #2, as described in the "SEMS" event. Pt #1's record lacked paper or electronic charting for the original mislabeled blood that was given, therefore lacked that the patient and blood was verified, lacked the vitals signs, and lacked documentation of the amount of blood transfused, and lacked documentation if there was any transfusion or adverse reactions.

5. The Blood Administration Policy dated 06/19/24 was reviewed. The policy stated, "... IV. Implementation - Obtaining/Issuing a blood component to be transfused ... d. Patient Identification: Patient and blood component verification must be performed using the EMR (electronic medical record) and Blood Bank database. Recipient and unit formation should be verified immediately before transfusion without interruption and in the presence of the recipient (at the patient bedside). * Scan patient armband. * Scan the barcodes on the blood component. * System will display a message notifying the transfusionist of electronic verification. * The following information must be included in the verification process by the transfusionist at the patient bedside: i. Patient identifiers on the blood or component unit label that must match the identity of the recipient ... Appendix II: Downtime Procedure for Blood Verification Process: 1. Two (2) qualified employees shall independently verify the patient information on the patient's armband (name, dated of birth, and medical record number) to the tag/form attached to the blood component ..."

6. An interview was conducted on 9/30/25 at 10:48 AM with Lab Supervisor (E#17). "In an order for emergent blood transfusion, the units are not crossmatched and the unit is given based on age and sex of the patient. Females over the age of 55 years and males are given O+ [both Pt #1 and Pt #2 are male patients, type O positive blood , positive for Rhesus factor/Rh factor, a protein present on the surface of red blood cells]...when blood is ready to be transfused, the lab tech will call the floor the patient is on and alert the nurse that the blood is being sent via the tube station ...the tech will give the nurse their badge number to unlock the tube station once blood arrives to the floor ...they can pick up blood in person as well in an Massive Transfusion Protocol box [Box picked up by nurse from blood bank which has the correct blood type for patient] (MTP)." Both patients were males and received the correct blood type, O+.

7. An interview was conducted on 09/30/25 at 2:30 PM with MLS (Medical Laboratory Scientist) (E #21). When asked about the blood transfusion for Pt #1, E #21 stated, "I had blood for (Pt #2) on the counter when I got the order for emergency blood on (Pt #1) ...the nurse came down to get the blood and I had the paper from (Pt #2) and put the sticker for (Pt #2) on the unit of blood and accidentally grabbed the unit of blood and put it in the box for (Pt #1) ...the box was labeled with (Pt #1's) information correctly ...after the nurse left with the blood, I was picking up and realized I sent the wrong unit with the nurse ...I tried to call and catch the nurse but couldn't so I called to ED that they should not hang it ...I contacted my supervisor too ...a little bit later they had never returned the blood to the blood bank so I called the ED again and asked if they had started the blood yet and they said they had to check ...they called back and said the blood was started so I told them to stop it ...it was the correct blood type but had the wrong label on it ...they brought the blood with (Pt #2 ' s) label on it back to the blood bank and got the correct unit for the (Pt #1)." (E#21) stated, "About 2 weeks or so after this incident, we had a meeting with lab and ED staff to discuss the incident." It is unclear on how much blood was transfused, as it was not charted on paper or in epic. The nurse was uncertain.

8. An interview was conducted on 09/30/25 at 3:10 PM with Registered Nurse/RN (E #18). (E #18) stated, "It was not my patient that I was caring for, I just went down to the lab to get that emergency release blood ... I was given (Pt #1) labels from the primary nurse ... I went to the blood bank and I received the unit of blood ... the lab checked it against the labels that I gave them or it looked like [lab] did and then I brought that back... At that time, it was unclear we used a similar order set for mass transfusion and emergency release. Mass transfusion apparently does not have the patient label on the bag itself. I did not know that emergency release does contain a patient label so after starting the blood on (Pt #1), lab called and said the wrong label was on the blood bag. We stopped the blood immediately (it was documented on how long it ran or how much was given) and I went down and got the correct unit of blood ... we ended up starting the correct unit. As far as I know the first unit was the same blood type for both patients (Pt #1 and Pt #2) ..." When asked if the nurses would look at the bag to notice the sticker on the back of the blood bag, (E#18) stated " ...none of us knew to look on the back of that bag. We thought it was the same process as the mass transfusion, which does not have the sticker on the back of the unit of blood... at the bedside, we verify that it's unmatched blood and hang it (The only thing they did not do was view the patient label).... emergency release blood has a sticker on the back with patient information that we scan into Epic (Electronic Health Record) to verify it, we see on the patient's wristband and we see on the sticker ...scan it into Epic ...that's what's supposed to happen on emergent release blood ...that did not happen because we were unclear ... I thought it was the same process as the mass transfusion ... documentation is all done on downtime paper charting forms ..." When asked if any education has been done after the incident, (E#18) stated " ...I was involved in a meeting and discussed the event, but I cannot speak to any other education given out to the rest of the department after that." E#18 verified the patient's identity, saw that it was still the correct blood type, but the incorrect patient's label. E#18 then returned the remainder of that patient's blood to blood bank and picked up the correct blood.

9. An interview was conducted on 09/30/25 at 3:40 PM with ED RN (E#20). (E#20) stated, "We received the order for a unit of blood ...ED RN (E#18) went and got that unit of blood [per Pt #1's record E#20 acknowledged the order and transfused the blood], we saw the O positive, the uncrossmatched and hung the blood... I thought emergent release was the same as MTP (Mass Transfusion Protocol) and it was paper charting, so I wasn't even in the computer. I believe by the time blood bank called me, there was confusion... maybe the (Pt#1) medical record or encounter number was wrong... so I was checking (Pt#1)'s arm bands and then finally when I went to the unit of blood, I flipped it over and saw (Pt #2)'s label so I immediately stopped it ... I let our charge RN know ...the patient was stable, so we left the blood stopped, we took that unit back to blood bank eventually and somebody else went and got another unit and we hung that ..." When asked about any follow up or education after the incident, E#20 stated " ...we had a meeting with staff from the lab and staff from the ED to try and figure out a better process ...it was 3 to 4 weeks after the incident."

10. An interview was conducted on 09/30/25 at 3:45 PM with the Director of Emergency Services (E#13). When asked about any staff education after the incident with (Pt #1), (E#13) stated, "We have a small handout to give everyone and we're doing it in huddles ... if it's in huddles we may not have record of that. We did have re-education which was necessary and completed in the Emergency Department and the Laboratory."

11. An interview was conducted on 10/1/25 at 11:30 AM with ED Staff RN (E#12). When asked to identify documentation related to Pt#1's chart regarding patient's receipt of PRBCs (packed red blood cells) on 7/18/25, (E#12) stated, "The only documentation regarding this is what the nurse completed, the downtime transfusion record. There are no comments or documentation related to the first unit that was started and stopped due to incorrect patient identifier. I am not sure why there is no documentation in the chart." When asked if any education had been provided to the ED staff regarding MTP and Emergent Release Blood Transfusion after this incident on 7/18/25, (E#12) stated, "No, not to my knowledge."