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A. Based on document review and interview, it was determined that the Hospital's policy for administration of blood products failed to include specific parameters for changes in vital signs in order to identify any adverse reactions the patient may experience during or related to the transfusion.

Findings include:

1. The Hospital's policy titled, "Blood and Blood Products, Administration (Adult and Pediatric)" (date initiated 6/15/2007), was reviewed on 12/6/2022 and required, "...Prior to transfusion explain the possible signs and symptoms of a transfusion reaction to the patient. Reactions can occur within 15 minutes of transfusion initiation up to 14 days post transfusion: Signs and Symptoms: ...blood pressure changes, severe hypotension/shock..."

2. An interview was conducted with a Registered Nurse (E#8) and the Chief Nursing Officer/CNO (E#9) on 12/6/2022, at approximately 1:45 PM. E#8 stated that vital signs (including pulse, respirations, blood pressure, temperature, and oxygen saturation) should be monitored pre-transfusion, 15 minutes after start of the transfusion, and post-transfusion. When asked what changes in vital signs would indicate a suspected reaction. E#8 stated that it would depend on the patient's baseline and presentation; however, E#8 was unable to verbalize a specific parameter when she would stop the transfusion. E#8 stated that she hasn't done many blood transfusion and would look up the guidelines in the policy/procedure. The CNO (E#9) pulled the policy and was not able to find specific parameters to report for changes in vital signs. E#9 stated that "blood pressure changes" and "severe hypotension" can be subjective and left open to interpretation by the nurse.


B. Based on document review and interview, it was determined that for 4 of 4 records (Pts. #1, #6-#8) reviewed for blood transfusions, the Hospital failed to ensure that blood was transfused in accordance with policy.

Findings include:

1. The Hospital's policy titled, "Blood and Blood Products, Administration (Adult and Pediatric)" (date initiated 6/15/2007), was reviewed on 12/6/2022 and required, "...Pre-Transfusion: Obtain patient's vital signs and document in the BPAM flowsheet... During Transfusion: Remain with the patient during the first 15 minutes of a transfusion... Repeat vital signs within 15 minutes of beginning transfusion and assess for signs and symptoms of transfusion reaction or shortness of breath; document in the BPAM flowsheet... Post-Transfusion: Stop transfusion in the BPAM flowsheet: 1. Obtain post transfusion vital signs... Document volume infused..."

2. On 12/5/2022, Pt. #1 clinical record was reviewed. Pt. #1 arrived at the Emergency Department (ED) on 10/20/2020 at 3:10 AM, with a diagnosis of Abdominal Pain. A physician's order dated 10/20/2020 at 8:43 AM, included, "Transfuse Packed RBC [red blood cells] ... routine 2 units." Pt. #1's flowsheets included documentation of 2 units of RBC administered (Unit #1: W0397 20 085166 Z-E0336V00 was started on 10/20/2020 at 10:36 AM and Unit #2: W0397 20 082024 0-E0336V00 was started on 10/20/2020 at 11:32 AM). The end times for both transfusions were not documented for either RBC unit.

3. The clinical record of Pt. #6 was reviewed on 12/7/2022. Pt. #6 was admitted for labor & delivery/C-section on 10/11/2022. A physician's order was placed on 10/14/2022 to transfuse 2 units of PRBC. Blood Product Administration records indicated that the transfusion began on 10/14/2022 at approximately 10:18 AM; however, the record lacked documentation of what time the transfusion ended.

4. The clinical record of Pt. #7 was reviewed on 12/7/2022. Pt. #7 was admitted for abnormal uterine bleeding on 11/21/2022. Physician's orders were placed on 11/21/2022 and 11/22/2022 to transfuse a total of 3 units of PRBCs. Orders included "Vital signs prior to transfusion. 15 minutes after transfusion has begun and post transfusion." The first transfusion started on 11/21/2022 at 3:38 PM; however, lacked documentation of vital signs 15 minutes after start. Pt. #1 received another transfusion on 11/21/2022 from 6:22 PM to 6:50 PM and again on 11/22/2022 from 11:46 AM to 2:00 PM. The record lacked documentation of the patient's oxygen saturations under vital signs at the required intervals before, during, and/or after transfusion.

5. The clinical record of Pt. #8 was reviewed on 12/7/2022. Pt. #8 was admitted on 10/19/2022, with a diagnosis of paroxysmal atrial fibrillation (irregular heart rhythm). A physician's order was placed on 10/19/2022, to transfuse 2 units of PRBCs within 4 hours. The first unit transfusion was started on 10/19/22 at 4:24 PM; however, the record lacked documentation of what time the transfusion ended. The record also lacked documentation of the patient's oxygen saturations during the transfusion.

6. An interview was conducted with Registered Nurse (E #8) on 12/6/2022, at approximately 1:45 PM. E #8 stated that vital signs should be monitored pre-transfusion, after 15 minutes, and post-transfusion. E#8 stated that oxygen saturations would be considered vital signs to monitor during transfusion.

7. During an interview with the Manager of Clinical Operations (E #1) on 12/8/2022 at 10:30 AM, E #1 stated that "There should be an end time documented for the end of every transfusion".

Based on document review and interview, it was determined that the Hospital failed to maintain adequate laboratory services to meet the needs of its patients. As a result, the Condition of Participation, 42 CFR 482.27 Laboratory Services was not in compliance.

Findings include:

1. The Hospital failed to provide adequate laboratory services by ensuring that a policy for testing of questionable results was established and followed in order to meet the needs of its patients. (A-582 A)

2. The Hospital failed to ensure that the Laboratory reported an adverse occurrence (Pt. #1) to the Hospital's Patient Safety Committee for review as required by the Laboratory's Quality Plan. (A-582 B)

A. Based on document review and interview, it was determined that for 4 of 6 patient records (Pts. #1 and #9-#11) reviewed for blood screening, the Hospital failed to provide adequate laboratory services by ensuring that a policy for testing of questionable results was established and followed in order to meet the needs of its patients.

Findings include:

1.The clinical record of a patient (Pt. #1) who had a blood transfusion reaction in 2020 was reviewed.

The clinical record of Pt. #1 was reviewed on 12/5/2022. Pt. #1 was a pregnant female who arrived at the Hospital's Emergency Department (ED) on 10/20/2020 at 3:10 AM, with a chief complaint of abdominal pain and a diagnosis of sickle cell crisis. Pt. #1 had multiple health issues during her pregnancy including hemolysis and low platelet (HELLP) syndrome. On 10/20/2020, Pt. #1 was type and screened for antibodies and the results were "negative". Pt. #1 received two units of packed red blood cells (PRBC). Pt. #1 had a cesarean delivery and was discharged on 10/22/2020 (2 days post-op) in "stable condition".

-Pt. #1's Blood Bank Work-Ups, dated 10/20/2020, were reviewed on 12/8/2022. The Blood Type and Screen Test Results from 10/20/2020 indicated that the blood antibody result had been manually modified from "equivocal" / "?" [neither negative or positive] to Negative.

Pt. #1 was readmitted on 11/4/2020 due to lower back pain. A progress note on 11/4/2020 at 10:30 AM, included, " ...On the night of 11/4/2020, patient developed tachycardia tachypnea and that is when we realized that she was hemolyzing because her hemoglobin was 4.4 ...Blood bank identified that she had antibodies to C and S antigens which were not present on the screen she had on 10/20/2020 ... Delayed transfusion reaction to the blood products she received about 2 weeks ago ..."

-Pt. #1 expired on 11/6/2020. Death certificate dated 11/6/2020 indicated cause of death was "Cardio- Respiratory Arrest - Code Blue and Delayed Hemolytic Transfusion Reaction."

-Antigen Testing, dated 11/5/2020, of the 2 Blood Units transfused to Pt. #1 on 10/20/2020 were reviewed on 12/8/2022 and indicated that both units tested positive for Antigen C. The units were not tested for Antigen S.

2. An interview was conducted with the Laboratory Manager (E#4) on 12/8/2022, at approximately 2:30 PM. E#4 stated that the units could not be tested for Antigen S at the time because they didn't have the necessary components. E#4 stated that there was a possibility that both units transfused on 10/20/2020 could have been positive for Antigen S as well, and stated that being positive for Antigen C was "already bad enough." E#4 stated that the purpose of screening for antibodies is to ensure that the patients get the right blood. E#4 stated that if a patient has antibodies against S and/or C, then they should not receive blood that has these antigens, or it could cause a transfusion reaction which could be fatal.

3. A Laboratory Occurrence Report, dated 5/13/2022, was reviewed on 12/8/2022 and included, "Reported by: [Senior Lab Technician/E#2] ... The antibody screen result for [Pt. #1] was changed from question mark to negative without thorough workup on 10/20/2020. Two units of type specific ... RBCs were transferred on 10/20/2020 ... During an emergency return visit on 11/5/2020, anti-C and -S were discovered. Patient passed away due to complication secondary to delayed hemolytic transfusion reaction. Why do you think this occurred: ..."There was no procedure for reviewing and reporting questionable results from ECHO [machine used to test blood type & screen]. Tech were told or allowed to change ECHO questionable results to negative or positive based on personal interpretation. Recommendations: The ability to change result on ECHO has been removed from all tech except senior tech and designee(s) as of 04/29/2022. Proc. 4840-BB-2006 has been updated and Proc. 4840-BB-2006.2JA is in place to address all weakly positive and questionable results as of 03/17/2022."

4. The Hospital's Laboratory policy titled, "Positive Antibody Workup (PROC.4840-BB-2006)" (adopted 3/17/2022), was reviewed on 12/7/2022 and required, "...The antibody identification (ABID) is left pending until the ABWU [Antibody Work-Up] is complete. The performing tech will give workup to second tech to review. Reviewer will result the ABID in SOFTBank [blood service information system] accordingly: ...If antibody screen is questionable, refer to PROC.4840-BB-2006.2JA... ABID must be reviewed and resulted by a second tech..."

5. The laboratory blood screening records for patients (Pts. #9-#11) who had weakly positive/questionable results from 12/6/2022, were reviewed on 12/7/2022 and indicated that additional required testing was being conducted; however, it could not be determined that the process and results were verified by a second technician by completion of the "Antibody Workup Review Checklist" as follows:

- Pt. #9's record lacked a completed "Antibody Workup Review Checklist" to confirm all steps were followed and verification of results by a second tech.
- Pt. #10's record lacked a completed "Antibody Workup Review Checklist" to confirm all steps were followed and verification of results by a second tech.
- Pt. #11 had a filled Antibody Workup Review Checklist to indicate the steps were followed; however, the form lacked the signature of the final review/second tech.

6. An interview was conducted with the Laboratory Medical Director (MD#1) and VP of Operations (E#7) on 12/6/2022, at approximately 11:50 AM. MD#1 stated that back in May 2022, the Senior Tech (E#2) had sent an email out to all the Lab staff regarding verification of uncertain results and stated that the ability to modify results on the ECHO (antibody testing equipment) was removed. The reason stated on the email was that staff had missed several clinically significant antibody(ies) recently and in the past, by not performing a full antibody panel. The email referred staff to follow the new procedure (PROC.4840-BB-2006). After the email was sent out, E#2 discovered there were still some concerns with staff not following the new procedure, especially during the second shift. MD#1 stated that since E#2 was going on leave and they realized that there was still an issue, they've implemented a new change to the procedure in November 2022 that necessitates completion of the "Antibody Workup Review Checklist." This checklist requires the techs to document that each step is followed and that two techs sign off verification of the results. MD#1 stated that implementation of the new form has started as of 12/1/2022; however, the policy was not changed yet to include implementation of this new checklist. Evidence of education of the new process and monitoring/oversight that the process is being followed was requested; however, MD#1 stated that these changes have been verbally communicated to all staff but there was no formal documentation of training or monitoring.


B. Based on document review and interview, it was determined that the Hospital failed to ensure that the Laboratory reported an adverse occurrence (Pt. #1) to the Hospital's Patient Safety Committee for review as required by the Laboratory's Quality Plan, to ensure adequate services were provided to meet the needs of its patients.

1. A Laboratory Occurrence Report, dated 5/13/2022, was reviewed on 12/8/2022 and included, "What Happened (details of the event or error): The antibody screen result for [Pt. #1] was changed from question mark to negative without thorough workup on 10/20/2020. Two units of type specific ... RBCs [red blood cells] were transferred on 10/20/2020... During an emergency return visit on 11/5/2020, anti-C and -S were discovered. Patient passed away due to complication secondary to delayed hemolytic transfusion reaction. Why do you think this occurred: ..."There was no procedure for reviewing and reporting questionable results from ECHO [machine used to test blood type & screen]. Tech were told or allowed to change ECHO questionable results to negative or positive based on personal interpretation..."

2. The Hospital's Laboratory Quality Plan (undated), was reviewed on 12/8/2022 and required, "Occurrence Event Management: Provides direction for the laboratory's processes and procedures to capture events in order to identify systemic problems and commit to removing the cause and thus reduce risk... Root Cause Analysis is done based on the occurrence. Documentation is done on the laboratory occurrence form... When occurrence information is received it is reviewed and analyzed to facilitate identification of patterns or trends that highlight the need for a root cause analysis and corrective action ... The quality activities in the laboratory are reported within the hospital, and the laboratory is a member of the following committees where quality is discussed: Hospital Quality Committee ... Safety Committee"

3. The Hospital's Quality/Patient Safety Committee Minutes from 11/2020-12/2022 were reviewed and did not address the occurrence with Pt. #1.

4. The Root Cause Analysis (RCA) and Action Plan from the Hospital (created 11/2020 and updated 11/24/2022) regarding Pt. #1's mortality review from 11/2020 were reviewed on 12/8/2022 and did not address concerns with laboratory staff modifying antibody results.

5. An interview was conducted with the Director of Quality, Safety, and Regulatory Affairs (E#5), the Manager of Regulatory Affairs (E#6), the Director of Laboratory (E#3) and the Medical Director of Laboratory (MD#1) on 12/8/2022, at approximately 11:30 AM. E#3 stated that the Laboratory has their own occurrence reports that are completed on paper. The forms will be signed by the managing staff and if required, will be reported into the Hospital's Online Incident Reporting System (MIDAS). E#3 stated that they do not usually report occurrences into MIDAS. E#5 stated that no incident report was filed for this patient in Hospital's MIDAS system. E#5 stated that the concerns discovered in May 2022 regarding the lab techs changing the results was not reported to the Hospital's Quality Department. MD#1 and E#5 stated that going forward, they will require all incidents (including laboratory) to be reported in the Hospital's online MIDAS system (per E#6, the meeting with MIDAS is scheduled for 12/14/2022). E#5 stated that it is a work in progress, but now that they are aware, they plan to do a full blood audit review from nursing to laboratory. E#5 stated that lab will be included in the quality process and will ensure that education and monitoring of staff are completed.