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Based on records review and interviews, the hospital failed to administer blood products to patients in a safe manner. As a result, a Patient #27 received the incorrect blood type and died. The hospital failed to do the following in preventing the blood transfusion fatality:

1. The Emergency Department (ED) obtained blood from a patient with no physician order and failed to discard excess blood vials.

2. After the patient was discharged, Environmental Services (EVS) failed to notify the ED a blood specimen was left in the room. ED staff failed to check room for bodily fluids after patient was discharged.

3. The ED nurse failed to correctly label a blood specimen. This resulted in a blood specimen with two different patient labels (double labeled).

4. The laboratory department failed to reject the double labeled blood specimen received from ED.

5. The inpatient clinical staff failed to recognize possible signs and symptoms of blood transfusion adverse reaction.

6. The nursing staff failed to check vital signs during a blood transfusion per policy and procedure.



Records review indicated the following findings:

Patient #27 was a 75 year old female with a history of recent multiple falls, hypertension, and diabetes. She came to the facility's ED on December 2, 2018, at 11:42 AM for altered mental status. A computed tomography (CT) revealed the patient had bleeding into the space surrounding the brain. Additional diagnoses included acute encephalopathy, severe sepsis, anemia, coagulopathy, and an acute kidney injury.

After consultations with a neurosurgeon, neurologist, and intensivist, the providers decided Patient #27 did not need surgical intervention for brain hemorrhage and patient will be admitted to an intensive care unit. Physician recommended treating the patient's anemia with a packed red blood cell (PRBC's) transfusion and treating the coagulopathy with a fresh frozen plasma (FFP) transfusion.

At 4:59 PM, while Patient #27 was still in the ED, a type and screen was ordered. The blood was received and accepted to laboratory department (lab) at 5:10 PM from the ED.

At 5:44 PM Patient #27 was transferred to the Medical Intensive Care Unit (MICU).


On December 2, 2018, the patient received a FFP transfusion from 8:54 PM to 11:15 PM.

At 11:15 PM, when the FFP transfusion was completed, the systolic blood pressure was noted to be 48 points lower than initial systolic Blood Pressure- from 158/80 to 110/55.


On December 3, 2018, a midnight assessment completed by RN #47 documented "blood in the urine." This is the first documentation of blood in Patient #27's urine since her visit at hospital.


On December 3, 2018, at 1:10 AM., RN #47 documented the following: "Provider notification: change in status hematuria Resident #1 notified by telephone; resident at bedside; no new orders."

Patient #27 received the PRBC's transfusion on December 3, 2018, from 1:17 AM to 0410 AM.

At 4:10 AM, upon completion of the PRBC transfusion, RN #47 documented a blood pressure of 60/45 for patient #27. This was the first low blood pressure documented. RN#47 notified resident on call. A blood transfusion reaction was suspected and investigation started.


On December 3, 2018, at 4:24 AM, the Laboratory director noted the following: "ABO incompatible transfusion reaction- Disseminated Intravacular Coagulation (DIC) and hypotension followed. Transfusing ABO-compatible products." Patient #27 blood type was B+, the Fresh frozen Plasma (FFP) and PRBC's that was transfused was A+.

Physician notes indicated that Patient #27 became critically ill and required various interventions in an attempt to stabilize the patient. This included 30 units of various blood products transfused, intravenous medications to stabilize, multiple invasive lines insertion including intubation (inserting endotracheal tube from mouth to trachea to maintain and assist with breathing), additional physician consults, additional blood lab testing, and various further testing.

Physician notes states CT of the brain was completed on Patient #27 on December 3, 2018, at 10:30 AM. Results revealed "increased/new bilateral subarachnoid hemorrhage".

Patient #27 had a total of four cardiac arrests with advanced cardiac life support on December 3, 2018, over a three hour timeframe. The family decided to withdraw care after the fourth cardiac arrest. Patient #27 expired December 3, 2018, at 12:50 PM.



1. The Emergency Department (ED) obtained blood from a patient with no physician order and failed to discard excess blood vials. Finding include:

A Root Cause Analysis (RCA) was initiated by the hospital after the death of Patient #27 (the RCA was ongoing at time of survey). The RCA documented the initial type and screen that was sent from the ED to the lab was not Patient #27 blood, but patient #28 blood specimen. Patient #28 was in ED room XX and admitted to an inpatient unit at hospital on December 2, 2018. Patient #27 was the next patient admitted to room XX in the ED. Record review on January 10, 2019 indicated that Patient #28 did not have an order for a type and screen while in the ED.

The Director of the Emergency Department and Director of Risk Management were interviewed on January 8, 2019. According to the interview, prior to the death of Patient #27, it was a normal practice to draw a "rainbow" (the practice of drawing extra vials of blood without a physician order) of blood work. The ED nurse would wait for the orders and use the blood that was already drawn to send.

Records review showed the hospital had no policy or procedure for drawing "rainbow" blood tubes. During an interview with the ED Director, CNO and The Training/Education & Research Director on January 8, 2019, all acknowledged the ED practiced drawing rainbow blood tubes prior to the death of Patient #27.


2. After the Patient #28 was discharged, Environmental Services (EVS) failed to notify the ED that a blood specimen was left in the room. ED staff failed to check room for bodily fluids after patient was discharged. Findings include:

During an interview with the ED Director and Risk Manager on January 8, 2019, it was asked who is responsible for checking the room for body fluids after a patient is discharged. When a patient is discharged it is the nurse or patient care assistant (PCA) responsibility to remove all bodily fluids in the room prior to environmental services (EVS) cleaning the room. EVS will not remove bodily fluids from a patient room.

During an interview on January 8, 2019, at 9:54 AM, the EVS Director was asked what the responsibilities were for the EVS technicians in the emergency department. EVS director said the EVS staff clean counter tops, cabinets, stretchers, high dust the rooms, and sanitize all surfaces. EVS Director was asked what the responsibilities were for EVS staff when they found specimens of blood, bodily fluids in the room. EVS director said they are to stop and notify the nurse. EVS staff will not clean the room until the nurse removes the blood/urine specimens. EVS said all staff had been trained on the "New" protocol about a month ago. EVS director was asked to provide documentation of the training conducted with EVS staff.

The EVS Director provided a document dated June 18, 2018, which was prior to the incident that occurred in December 2018 involving Patient #27.

No documentation was provided on staff training/education for cleaning patient rooms in the emergency department.

One blood vial was left in ED room xx after patient #28 was discharged. As a result of the ED room not being checked for bodily fluids by appropriate staff, the blood specimen stayed in the room for over 10.5 hours and was still in the room at the time patient #27 was admitted.


The ED nurse failed to correctly label a blood specimen. This resulted in a blood specimen with two different patient labels (double labeled). Findings include:

A Root Cause Analysis (RCA) was initiated by the hospital after the death of Patient #27 (the RCA was ongoing at time of survey). The RCA documented the initial type and screen that was sent from the ED to the lab was not Patient #27 blood sample, but Patient #28 blood sample. The RCA noted while Patient #27 was in the ED, a type and cross was ordered. The specimen tube in the ED room already had a patient label on it. A second label was placed over the blood (patient #27 label) and sent to lab.

CHI St. Luke Health Policy and Procedure- Specimen Identification, Collection and Transportation-Pathology that was effective July 2017 states: "Specimen Collection and Labeling Process ....ii Collect the appropriate specimen(s) and place one label on the primary container in the presence of the patient."

The policy also stated, for transfusion service specimens the only two acceptable labels are "epic specimen label or a handwritten label".


An interview was conducted with the Training/Education & Research Director on January 8, 2019. The Director of Education stated applying multiple patient labels on specimens was a "bad practice" and "sloppy practice". the Director of Education also stated multiple labels on a lab specimen was a safety issue.


The lab department failed to reject the double labeled blood specimen received from ED. Findings include:

CHI St. Luke Health Policy and Procedure- Specimen Identification, Collection and Transportation-Pathology that was effective July 2017 states: "Specimen Collection and Labeling Process ....ii Collect the appropriate specimen(s) and place one label on the primary container in the presence of the patient."

The policy also stated for transfusion service specimens the only two acceptable labels are "epic specimen label or a handwritten label".


Audit reports from July 2018 to January 2019, showed the lab rejecting lab specimens with multiple labels on tubes.

On January 10, 2019, at 5:00 PM, the hospital CEO was interviewed concerning the pattern of mislabels on blood tubes to be type and screen. The CEO stated, it should be zero. "This are patients life and blood is important". The CEO stated that they will have to retrain all the nurses to ensure that there are no mislabels of blood sample tubes. The CEO stated, "This is unacceptable".


The inpatient staff failed to recognize possible signs and symptoms of blood transfusion reaction. Nursing staff failed to check vital signs during a blood transfusion per policy and procedure. Findings include:


CHI St. Luke health Transfusion of Blood Products-Patient Care states the following:

"Check vital signs 15 minutes after making any connection. (Initial vital sings must be within the previous 15 minutes)"

"Monitor vital signs and assess temperature and urine throughout the transfusion process to monitor for adverse reactions to blood products and the effectiveness of treatment. Vital signs are done every hour, and when the transfusion is complete."

"Monitor for signs and symptoms of transfusion reactions."

"Symptoms of a transfusion reaction ......

iv. Increase or decrease in blood pressure of more than 20mmHg ..... ...

xi. Hypoxemia (change in oxygen saturation of greater than 5% or any decrease to less than 90%) .....

xiv. Hematuria/dark urine"

"In a suspected transfusion reaction, IMMEDIATELY:

i. Stop transfusion and maintain patency of IV line ... ....

vii. Notify transfusion Service and physician. Notification of Transfusion Service must be within 15 minutes of reaction."


During Patient #27's FFP transfusion the following vital signs were not documented:

On December 2, 2018, at 10:00 PM hourly and 11:00PM hourly no temperature.

On December 2, 2018, at 10:00 PM hourly pulse.

On December 2, 2018, at 11:00 PM hourly blood pressure.


During Patient #27's PRBC transfusion the following vital signs were not documented:

On December 3, 2018, at 2:00 AM hourly, 3:00 AM hourly and 4:00 AM hourly Temperature.

On December 3, 2018, at 4:00 AM hourly Pulse.

On December 3, 2018, at 2:00 AM hourly, 3:00 AM hourly and 4:00 AM hourly Blood Pressure.


On January 9, 2019, RN #47 was interviewed. This nurse verified she was assigned to Patient #27 on December 2, 2018, during 7:00 PM- December 3, 2018 7:00AM. When assessed at the beginning of shift (7 PM) Patient #27 was alert and oriented with occasional confusion and was not on supplemental oxygen. RN #47 also confirmed she administered the FFP and PRBC's to Patient #27. This nurse verbalized, she noticed a change in the color of urine around midnight December 3, 2018, and notified the resident on-call (Resident #1). The resident decided to continue monitoring patient. RN #47 said the next change in condition was toward the end of PRBC transfusion when the BP was 60/45, RN #47 notified physician and blood transfusion reaction was suspected.

RN #47 acknowledged all vital signs were not completed per policy during blood products transfusion.

Based on interview and record review, the hospital Quality Assurance and Performance Improvement (QAPI) Program failed to ensure the measuring and analyzing of adverse events, and occurrences. QAPI also failed to implement corrective actions for reports reviewed from October 2017 - January 2019. The focus of this survey was based on a blood transfusion adverse event involving laboratory services, blood bank, environmental services, and nursing services.

Findings:

1. Patient #27 received the wrong blood type on December 2-3, 2018, as a result of mislabeling of blood specimens by facility staff.

2. Patient #27 had a transfusion reaction, developed severe complications, and died.

The hospital failed to ensure occurrences involving mislabeling were addressed and corrective actions implemented prior to and after the December 2- 3, 2018, incident.

3. The facility failed to ensure the identified concerns with nursing services recognition of transfusion reactions were addressed and corrective actions implemented.

4. The hospital failed to ensure information received about nursing services having problems with the electronic charting transfusion documentation were addressed and corrective actions implemented. The facility was tracking the problems, but failed to trend so corrective actions could be implemented and monitor.

This deficient practice had the likelihood to cause harm in all patients who had blood laboratory test drawn in the hospital.


Review of facility's occurrence reports and investigations revealed the following:

From September 2018 - January 9, 2019, there were 122 incidents involving mislabeling or problems with labeling of blood (type and screen) laboratory specimens.

Review of an Emergency Department (ED) occurrence dated November 28, 2018, revealed the following:

On November 28, 2018, the blood bank received a request for 1 unit of packed red blood cells (PRBC's) and 1 unit of platelets on the wrong patient. The blood product ordered were missing a type and screen order (this test is used to determine the patient blood type). The ED was notified the blood products ordered was placed on the wrong patient and the type and screen order was missing. The incorrect order was canceled and the correct order was placed. There was no documentation as to what corrective action was implemented. Patient #51 and #52 were the involved in the incident.


Review of an Emergency Department occurrence dated December 3, 2018, revealed the following:

"Patient developed severe hypotension at the end of PRBC (Packed Red Blood Cell) transfusion. Transfusion reaction panel sent. Reportedly type and screen had been mislabeled resulting in likely ABO (antibodies blood group) mismatch."

Review of the hospital internal investigation revealed Patient #27 received the wrong blood type transfusion on December 2-3, 2018, as a result of mislabeling of blood specimens by hospital nursing staff. Patient #27 had a transfusion reaction, developed severe complications, and died.


Review of an ED occurrence dated December 21, 2018, revealed the following:

A PRBC transfusion order for patient #59 in the ED was started documented on the electronic flowsheet (by RN #30) but product was not stopped nor completed in flowsheet. The patient was transferred to ICU (unit 7 South 2) around the time the blood product might have stopped.

Review of the ED record on patient #59 revealed, he had a potential blood transfusion reaction. patient #59's unit of blood was sent to the laboratory for investigation of a transfusion reaction.

This event was not documented in the occurrence information.


In January 2019, there were 21 incidents involving mislabeled tubes and 1 was doubled labeled.


During an interview on January 8, 2019, after 10:51 AM, the Quality Director reported that as a result of their investigation on Patient #27, they found the following problems:

1. A failure to follow their process for labeling in the ED.

2. A failure to recognize changes of blood transfusions reactions in the Intensive Care Unit.

The quality director reported the information about the new processes went to the clinical hospital staff on December 21, 2018, and were effective January 1, 2019.

During an interview on January 9, 2019, after 2:55 PM, the Quality Director verbalized he was not notified about the potential transfusion reaction on Patient #59 which occurred on December 30, 2018. The quality director reported he "knew for sure" he did not have an incident report on Patient #59 and not all blood transfusion reaction incidents are reported to the quality program.

During the same interview, the Quality Director stated "Every transfusion reaction did not result in a Root Cause Analysis (RCA). If it went to the transfusion services, they completed a form and they would refer it to clinical services and as needed for a RCA to review". When asked who was keeping up with nursing services ability to assess transfusion reactions the quality director reported an auditing tool was being developed today (January 9, 2019).


The Quality Director provided the information for the incident dated November 28, 2018, which revealed the incident was a near miss (an unplanned event that did not result in injury, illness or damage but had the potential to do so). There was no documentation as to what intervention was implemented to prevent this type of incident from occurring again.

The Quality Director was asked what was implemented after the November 28, 2018, incident. He reported the error was caught by the laboratory and it was a human error. The nurse entered the order in wrong patient medical record. The patient's physician was notified of the order error and the incident was not escalated to the medical staff.


During an interview on January 10, 2019, after 2:45 PM., the following was revealed:

The laboratory director reported responsibility for monitoring utilization of blood transfusions. He was not satisfied with the number of blood transfusions that were left open by nursing. The director stated, the laboratory was not responsible for monitoring the nurse's documentation. Nurse #37 is responsible for monitoring nursing documentation for blood transfusions. Nurse #37 sent out a daily email to the laboratory, nurse managers and transfusion services with the problems found.

The Laboratory Director reported that the chain of command for information sharing was from blood transfusion committee to quality of care. If it was up for peer review it went directly to the Medical Executive Committee. If not up for peer review it went to Quality, Medical Executive Committee and then to the Governing Body.

RN#37 reported that he kept up with the nursing portion of the audits and sends the audits out to the nursing departments daily. The audit included the number of transfusions records which were not closed. RN #37 reported he was not trending the numbers. They were in the process of developing a tool to trend several subjects including blood transfusion reactions.

RN#37 verbalized the quality director receives the daily audit report.


Review of the Transfusion Committee minutes revealed the following concerns involving blood specimens:

1. October 26, 2018:
"Staff Nurse Practice Professional Council is developing an educational plan to improve bar code identification. Recent incident of wrong blood in tube points to the need to improve performance. Mandatory nursing skills fair is planned on a quarterly basis."

2. January 25,2018:
"Turnover in nurses seems to be leading to ongoing problems with closure of transfusion events in Epic. Ongoing training will be needed."

3. July 2018
Two Quality Alert were sent out for the following:

"Improperly labeled samples.

Samples are being received in laboratory with labels affixed incorrectly.

Units are sending samples to Pathology with labels that are crooked or improperly positioned on the tube.

Labels not affixed straight on the tube are unable to be read on laboratory analyzers

Samples must be re-labeled once received in lab, causing a delay in processing/analysis and potential for identification errors.."

4. "Barcode Label Printer Maintenance.
Sample labels are being printed on dirty printers causing inferior label quality and readability."

5. Review of quality committee minutes from July -December 2018 revealed the following four performance improvement projects for the last six months;

"Sepsis and epic Optimizations

Universal Protocol

VTE Risk Assessment EPIC Build Overview

Improving Nutrition in the ICU."


There was no project improvement in place to address nursing recognition of blood transfusion reactions.

Review of the facility's Quality Manual 2018 "pages 5 and 6 revealed the following:

"..The QMS (Quality Management System) program includes, but is not limited to the following:
A focus on indicators related to improved health outcomes and reduction of adverse events.

An ongoing process to demonstrate measurable improvement in indicators for which there is evidence of improved health outcomes and reductions in adverse events:

Measurement, monitoring, and analysis of quality and patient safety indicators, including adverse events, and other aspects of performance to assess processes of care, treatment, services, and operations provided; and

Continual improvement of health outcomes and reducing risk for patients.."

Based on observation, interview, and record review:

1. The hospital's nursing staff failed to monitor and document blood transfusions of patients in accordance with facility policy, medical record procedures, and current standards of practice. Vital signs of patients who received blood transfusions were not documented in accordance with facility policy (Patients: #5, #6, #12, #16. #17, #18, #19, #39, #29, #32, #35, #36, #40, #41, #43, #45, #51, #52, #56, #57, #59, #61, #65).

2. The "Single Blood Transfusion" patient event in the EMR (electronic medical record) was not consistently ended or completed at the end of the blood transfusion, which resulted in an inaccurate and incomplete patient record (Patients #41, #43, and #45).

The single blood transfusion record for Patient 43 was altered 2 days after a blood transfusion finished; the electronic record was not ended or completed (closed) at the end of the blood transfusion and was left opened. This resulted in an inaccurate and incomplete medical record (Patient #43). The volume of the blood product transfused was not consistently documented in the "Single Blood Transfusion" record (Patient #39, #41, and #42).

3. The hospital failed to ensure that blood or blood components for transfusions were transported in a safe manner. Staff that had not been trained were transporting blood and blood components from the blood bank to the patient unit. Nursing staff were unaware of which personnel, by title, could transport blood or blood components. There was no policy stating who could pick up blood products from the blood bank and there was no training on transporting blood products from the blood bank to the unit.

4. The hospital failed to ensure that nurses were able to monitor patients receiving blood transfusions in a safe manner. Nurses performing blood transfusion responsibilities did not know which alerts would be triggered by the EMR to indicate that a patient was having a possible transfusion reaction. Nurses interviewed stated that up to 5 vital signs indicators (temperature, pulse, respirations, blood pressure, and oxygen saturation) would alert in the EMR, when the system actually only alerted 2 vital signs indicators (temperature and oxygen saturation). This indicates that nurses have a lack of knowledge and training on the blood transfusion component of the EMR. This presents a risk that any patient having a blood transfusion could potentially have a serious transfusion reaction that would not be recognized emergently if a nurse was relying on the EMR for nonexistent alerts.

The findings present a likelihood that serious blood transfusion reactions may not be detected in an expeditious manner, which could delay appropriate response and treatment, and could result in death or injury to a patient. The findings also present a risk that an inaccurate or incomplete blood transfusion medical record could result in errors in patient diagnosis and treatment. The deficient practices had the potential to affect all patients receiving blood products at the hospital.



Findings included:

Review of patients who received blood transfusion:

Review of the facility policy titled, "Transfusion of Blood Products - Patient Care" dated May 2018 revealed the following:

"POLICY:

A. Prime with only 0.9% Sodium Chloride solution.

B. Check that no medication or other IV solutions are infusing with blood products ....

H. If the blood product component container is entered for any reason, the component will expire after 4 hours.

I. The blood product must be initiated immediately upon issue.

J. Transfusions should be completed within 4 hours and before the expiration date and time of the blood component ...

L. Transfusion reactions can be life threatening and occur with exposure to even a small amount of blood: therefore, transfusions should be started slowly unless the patient's condition requires a rapid, life sustaining transfusion. Baseline vital signs should be obtained within 60 minutes of initiation of the transfusion and should be reassessed at the end of the first 15 minutes, every hour and when the transfusion is complete.

M. All suspected transfusion reactions should be immediately reported to Transfusion services.

PROCEDURES: (NON-OPERATING ROOM AREA'S)

1. A physician's order is required for the transfusion of blood and blood products....

3. Assessment Before Transfusion:

a. Verify the correct patient using two patient identifiers (any two: name, medial record number, and/or date of birth ....

f. Assess vital signs, including blood pressure, heart rate, respiratory rate, oxygen saturation and temperature. (Initial vital signs must be within the previous 15 minutes)

4. Administration

a. Before initiating a blood or blood component transfusion:

1. Use a two-person verification process (two licensed staff)

2. Match the blood or blood component to the order

3. Match the patient to the blood or blood component

4. Verify blood product and patient match by checking blood bag tag, blood bag, and Patient identification band ....

l. Check vital signs 15 minutes after making any connection. (Initial vital signs must be within the previous 15 minutes)

o. After 15 minutes, if no signs of a transfusion reaction are noted, reassess vital signs and increase the flow rate to the desired speed. Infusion time should not exceed 4 hours ....

p. Monitor vital signs and assess temperature and urine throughout the transfusion process to monitor for adverse reactions to blood products and the effectiveness of treatment. Vital signs are done every hour, and when the transfusion is complete ....

8. Transfusion Reaction

a. Symptoms of a transfusion reaction.

1. Temperature elevation during transfusion

Greater than 1 degree Celsius or Greater than 2 degrees Fahrenheit

2. Chills/rigors

3. Tachycardia or bradycardia

4. Increase or decrease in blood pressure of more than 20 mmHG

5. Shock

6. Pain or burning at infusion site.

7. Chest pain or tightness

8. Back/Flank pain

9. Cough (New or increasing)

10. Shortness of breath or wheezing (Document all abnormal oxygen saturation

Measurements and treatments given when reporting a suspected reaction to transfusion
Service).

11. Hypoxemia (Change in oxygen saturation greater than 5% or less than 90 %)

12. Flushed skin

13. Nausea/Vomiting

13. Hematuria/dark urine

14. Diffuse bleeding

15. Urticaria/Hives


b. In a suspected transfusion reaction,

1. IMMEDIATELY stop the transfusion and maintain patency of IV line.

2. Scan the patient armband.

3. Select blood product transfusing and select "STOP" IN TV-PDA.

6. Monitor vital signs

7. Notify transfusion service and physician. Notification of transfusion service must be within 15 minutes of reaction ....

9. Placed unused portion of blood product and tubing in a plastic bag ...

13. Complete transfusion reaction Investigation form.

14. Send to transfusion service within 60 minutes of symptom onset:

1. Blood bag and tubing

2. 6 ml pink top EDTA tube

3. Blood transfusion reaction investigation form

Blood cultures if temperature elevation ..."



Patient #5:

Patient #5 had a diagnosis of shortness of breath, coronary artery disease, abnormal stress test, angina pectoris, coronary artery bypass grafting, hypertension, hyperlipidemia and gastroesophageal reflux disease. The patient was 66 years old. On January 6, 2019 a physician ordered 1 packed red blood cells (PRBC's) transfusion. The transfusion began at 4:20 PM. The electronic medical record (EMR) does not have a time when the transfusion was completed. This information was verified and validated by RN #52.

The pre-transfusion vital signs were taken at 4:15 PM: Temperature 98.6 F., Pulse 67, Respiration 24, Oxygen Saturation 92% and Blood Pressure 116/60.

No vital sign were documented at 4:45 PM.

At 5:00 PM: vital signs: Pulse 66, Respiration 20, Oxygen Saturation 98%. No Temperature or Blood Pressure were documented in the Blood Transfusion electronic template

At 5:18 PM: vital sign: Pulse 67, Respiration 28, Temperature 99.2 F.

At 6:00 PM: vital sign: Pulse 62, Respirations 13, no Blood Pressure or Temperature were recorded on the Blood Transfusion EMR.

At 7:00 PM: vital sign: Pulse is 81 and Respiration 32. No Temperature, Oxygen Saturation or Blood Pressure were documented on the Blood Transfusion EMR.


Patient #6:

Patient #6 had a diagnosis of pulmonary edema, congestive heart failure, type 2 diabetes mellitus, anemia, cardiogenic shock and sepsis shock. On January 3, 2019, a physician ordered 1 PRBC transfusion.

The transfusion was started on January 3, 2019, at 1:11 AM and ended on January 3, 2019, at 4:00 AM.

EMR review indicated that the pre transfusion vital signs at 1:11 AM were: Temperature 97.6 F, Pulse 82, Respirations 16, Blood Pressure 110/46, and Oxygen Saturation 100%.

At 1:23 AM (15 minutes after the blood transfusion started): only the Blood Pressure was taken 106/40.

At 1:30 AM: vital signs were: Pulse 79, Respiration 19, and Oxygen Saturation 100%. No Temperature or Blood Pressure were documented.

At 1:45 AM: vital sign: Pulse 79, Respiration 19, Oxygen Saturation 100%, and Blood Pressure 108/45. No Temperature was documented.

At 2:00 AM: vital sign: Pulse 81, Respiration 16, Oxygen Saturation 100%. No Temperature was documented.

At 2:03 AM: Blood Pressure 89/42, no Temperature, Pulse, or Oxygen Saturation was documented.

At 2:15 AM: Pulse 90, Respiration 26 and Oxygen Saturation 99%. No Blood Pressure was documented.

At 2:23 AM: Blood Pressure 89/41. No Pulse, Respiration, Temperature or Oxygen Saturation was documented.

At 2:45 AM: Blood Pressure 91/43, Pulse 81, Respirations 17, and Oxygen Saturation 100%. No Temperature was documented.

A 3:00 AM: Temperature 98.9 F. No Pulse, Blood Pressure, Oxygen Saturation, and Respirations were documented.

At 3:15 AM Pulse 84, Respiration 23, Oxygen Saturation 99%. No Blood Pressure was documented.

At 3:45 AM: Pulse 83, Respiration 20, Oxygen Saturation 100%, and Blood Pressure 116/40. No Temperature was documented.

The Blood Transfusion EMR is designed for the nurse to write a freestyle note as needed. However, no documentation was written on the template. There was no evidence that the nurse called the blood bank to notify changes on the patient vital signs, per hospital policy and procedure.


Patient #12:

Patient #12 had diagnosis of breast cancer and post breast lumpectomy. On January 8, 2019, a physician ordered 1 PRBC transfusion at Kirby Glen Infusion Center

The transfusion started on January 8, 2019, at 11:31 AM and ended January 8, 2019 at 1:42PM.

At 11:06 AM, the pre-transfusion Blood Pressure was 130/54, Pulse 77, Respiration 20, Temperature 98.3 F, and Oxygen Saturation of 97%. Electronic Medical Record showed no vital signs were done 15 minutes after the transfussion was started.

Vital Signs at 12:10 PM, Blood Pressure 116/63, Pulse 69, Respirations 16, Temperature 97.6 F, and Oxygen Saturation of 100% at two litters of oxygen.

At 1:10 PM, Blood Pressure 128/59, Pulse 52, Respiration 18, Temperature 97.6 F, and Oxygen Saturation 100% at two litters of oxygen. It was confirmed that there are no RN notes indicating the change on patient pulse from 77/minutes pre transfusion to 52/minutes.

At 1:42 PM, Blood Pressure 125/58, Pulse 58, Respiration 18, Temperature 97.9 F, and Oxygen Saturation 100 % at two litters of oxygen. Last set of vital sign were Blood Pressure 123/58, Pulse 55, Respirations 20, Temperature 97.9 F, Oxygen Saturation 100% at two litters of oxygen.

After the last set of vital sign, the patient was discharged home. The nursing notes does not address the patient pre transfusion Pulse of 77/minute and it went as low as 55/minute. The nurse administered two litters of oxygen, however, there is no note on the Blood Transfusion template that addressed the patient low pulse after the transfusion was started.

On January 10, 2019, at 2:15 PM, RN #52 was interviewed. The RN stated that the RN should address the change in the patient pulse in the EMR during the transfusion. RN #52 validated the starting pulse was 77 beats per minute, the last documented pulse was 55 beats per minute and the patient was discharged home. RN #52 also confirmed that the blood bank was not notified about the pulse changes.


Patient #29:

Patient #29 received two units of platelet products at Kirby Glen Oncology Infusion Center 12/13/18, from 3:49pm - 4:54pm. One of the two units (the 2nd platelet transfusion) did not have vital signs documented at completion of transfusion at 4:54pm.


Patient #32

Patient #32 received one unit of PRBC's November 24, 2018, from 11:48 AM-2:40 PM on 11 tower unit. There was no vital signs documented at completion of transfusion at 2:40 PM.


Patient #35

Patient #35 received one unit of FFP September 23, 2018, on 22 tower unit from 7:43 AM.- 9:17 AM. There was no vital signs recorded 15 minutes within start time of transfusion. The first set of vital signs were documented 47 minutes after transfusion started.


Patient #36

Patient #36 received one unit of PRBC's August 26, 2018, on 10 tower unit from 12:26 PM- 6:45 PM. The unit transfused for 6 hours and 19 minutes. Patient #36 also had no documentation of vital signs 15 minutes within start time of transfusion, at completion, and five of the six hours the blood was infusing.


Patient #56:

Review of the Daily Progress Notes for Hospitalist MD #9 on 8-2-2018 revealed the following:

Patient #56 is a 53-year-old caucasian male with a past medical history significant for marfan syndrome, chronic kidney disease stage IV, type I aortic dissection and aortic valve repair.

On July 15, 2018, Patient #56 had a resection and replacement a thoracic abdominal aortic aneurysm.

Review of the Blood Transfusion record for Patient #56 on August 2, 2018, revealed the following:

An order for Type and Screen, and transfuse one unit of PRBC was entered on August 2, 2018, at 7:57 AM.

The nurse listed on the blood transfusion record was RN #18. The second RN/verification signature was RN #19.

The blood transfusion was started at 1:54 PM on August 2, 2018, and stopped on August 2, 2018, at 2:30 PM. There was no documentation in the record at what time the blood product was picked up from the Blood bank.

Vital signs on the blood transfusion record show:

August 2, 2018

At 1:30 PM - Blood Pressure 149/54, Pulse 107, Oxygen Saturation 100 %, Respiration 19, Temperature 95. F. There was no documentation noted in the record for physician notification of the temperature level.

At 1:45 PM - Blood Pressure 152/52, Pulse 103, Oxygen Saturation 100 %, Respiration 17, Temperature 97.9 F.

At 1:54 PM - Blood Pressure 145/53, Pulse 107, Oxygen Saturation 100 %, Respiration 16, Temperature 98.2 F.

At 2:00 PM - Blood Pressure 113/46, Pulse 105, Oxygen Saturation 100 %, Respiration 55. There was no notification of physician or blood bank notification documented in the record of the respiratory rate increase. Temperature 98.4 F.

At 2:15 PM - Blood Pressure 129/49, Pulse 112, Oxygen Saturation 100 %, Respiration 26, Temperature 95.0 F. There was no notification of the physician or blood bank documented in the record of decreased temperature level.

At 2:30 PM - Blood Pressure 126/50, Pulse 118, Oxygen Saturation 100 %, Respiration 31, Temperature 98.4 F.

At 3:00 PM - Blood Pressure 168/60. There was no physician notification of the blood pressure elevation noted in the record. Pulse 106, Oxygen Saturation 100 %, Respiration 18, no temperature was documented.

At 3:15 PM- Blood Pressure 159/51, No additional vital signs were noted.

At 3:30 PM- Blood Pressure 152/49, No additional vital signs were noted.

At 3:45 PM -Blood Pressure 154/48, No additional vital signs were noted.

At 4:00 PM - Blood Pressure 149/47, Pulse 94, Oxygen Saturation 100 %, Respiration 16, no temperature was documented.

At 4:30 PM - Blood Pressure 152/59 - No additional vital signs were noted.

The next entry for vital signs was at 8:00 PM, Temperature was 98.1. There was no documentation in the record at this time for blood pressure, heart rate, respiration, or Oxygen saturation.


Patient #57:

History and Physical dated August 1st, 2018, dictated by the Hospitalist MD #5 revealed the following:

Patient #57 was a 55-year-old female with a history of atrial fibrillation, liver cirrhosis secondary to hepatitis C virus, end stage renal disease secondary to failed allograft on Hemodialysis (HD) right brachial graft. Pt# 57's active problems were listed as End Stage Renal disease (HCC) and Cirrhosis (HCC)."

A progress note from Hospitalist MD #7 on August 18, 2018 revealed the following:

"Patient #57 was transferred to Surgical ICU on August 13, 2018 with hemorrhagic shock. Hemoglobin was 6 and 2 units of PRBC's (Packed Red Blood Cells) were infused. Patient #57 was taken back to the Operating room for an exploratory laparotomy. The exploratory laparotomy revealed 1500 ml of clot posterior to the liver with a serosanguineous ascites within the abdomen. Arterial bleeding at the gallbladder fossa was identified and over sewn."

Review of the blood transfusion record for Patient #57 on August 18, 2018, revealed the following:

An order for type and screen, and transfuse one unit was entered on August 18, 2018, at 12:33 PM.

The blood transfusion record did not indicate a start time for the blood transfusion or a time when the blood product was picked up from the laboratory. There was a note on August 18, 2018, at 5:00 PM., that noted rate change but the note did not indicate what the rate had been changed to. There was a note that indicated a new bag was hung on August 18, 208, at 5 :15 PM. The stop time was noted to be 7:44 PM.

The nurse listed on the transfusion record was RN #27. The second signature/RN verification was RN #28.

Vital Signs were listed as below:

At 5:15 PM- Blood Pressure 118/53, Heart rate 82, Oxygen Saturation 98%, Respiration 23, Temperature 97.8 F.

At 5:45 PM - No Blood Pressure was documented, Pulse 80, Oxygen Saturation 90%, Respiration 25. There was no documentation noted in the record for physician/blood bank notification of the oxygen saturation level decreasing 8%. There was no documentation in the nursing notes for the decreased oxygen level.

At 6:00 PM - There was no Blood Pressure documented. Pulse 77, Oxygen Saturation 100 %, Respiration 18, Temperature 97.8 F.

At 6:30 PM - There was no Blood Pressure documented. Pulse 80, Oxygen Saturation 92%, Respiration 16. There was no documentation in the blood transfusion record or nurses note that addressed the oxygen saturation declining 5 %.

At 7:00 PM- There was no Blood Pressure documented. Pulse 76, Oxygen Saturation 100%, Respiration 11. There was no temperature documented. There was no documentation of physician notification in the nurse's notes regarding the respiration rate decreasing to 11.

At 7:43 PM - Blood Pressure 122/64, Pulse 79, Oxygen Saturation 100 %, Respiration 23, Temperature 97.8 F.

At 8:09 PM Blood Pressure 133/61, Pulse 78. Oxygen Saturation 97%, no Respiration rate or Temperature was documented.

At 9:11 PM was the next time vital signs were documented. Blood Pressure 115/67, Pulse 78, Respiration 17, no oxygen saturation or temperature was documented.

At 10:09 PM - Blood Pressure 112/65, Pulse 80, Respiration 22, Oxygen Saturation 100 %, no temperature was documented.


Patient #47:

Review of the Internal Medicine History & Physical revealed, Patient #47 was a 75-year-old male with past medical history of Prostate Cancer, status post radiation who presented to the emergency department with hematuria and had worsened over the last few evenings. Patient #47 had low systolic blood pressure in the emergency department and was given blood transfusion and IV fluids.

Review of the emergency department record revealed Patient #47 arrived in the emergency department at 5:54 PM on January 7, 2019. Triage was documented at 5:57 PM.

Review of the patient timeline revealed the following:

January 8, 2019

At 2:23 AM - Type & Screen was ordered by Emergency Department (ED) MD #8.

At 6:59 AM - ED MD # 8 notes low Blood pressure. Clinical appearance- will give blood products

At 3:30 AM - Blood labels were printed

At 3:42 AM - Type & Screen collected

At 4:33 AM - Type & Screen resulted

At 4:54 AM - Order for repeat H&H (Hemoglobin & Hematocrit) was ordered by ED MD #8

At 5:43 AM - Order for repeat Type & Screen was entered.

At 6:57 AM - Order for Transfuse 2 Units RBC by ED MD #8



Review of the Blood Transfusion Record revealed the following:

First Unit of PRBC (Packed Red Blood cells)

The nurse listed on the transfusion was RN #20. The verification/2nd RN was listed as RN #21.

The start time for the first unit of blood was listed as 9:29 AM, January 8, 2019, and the stop time was listed as 11:50 AM, January 8, 2019, on the transfusion record. The time indicating when the blood product was picked up from the lab was not documented in the record.

Vital Signs were noted on the blood transfusion as follows:

At 9:25 AM - Blood Pressure 84/53, Pulse 99, Oxygen Saturation 100 %, Respiration 22, Temperature 98.6 F.

At 9:44 AM - Blood Pressure 83/69, Pulse 98, Oxygen Saturation was 95%. There was no notation in the record for the change of 5% in the Oxygen Saturation. Respiration 21. Temperature 98.6 F.

At 10:15 AM - Blood Pressure 87/56, Pulse 94, Oxygen Saturation 99%, Respiration 20, Temperature 98.3 F. There was a note in the patient medical record that said, RN#20 notified the attending MD regarding patient status.

At 10:29 AM - Blood Pressure 95/52, Pulse 93, Oxygen Saturation 98%, Respiration 21, Temperature 98.2 F.

At 11:40 AM - Blood Pressure 87/56, Pulse 95, Oxygen Saturation 83%. There was a note from RN #20 that said, "the pulse oximeter was removed." There was no follow up with the Oxygen Saturation been documented. Pulse 95, Respiration 22, Temperature 98.3 F.

At 12:00 PM - Blood Pressure 102/56, Pulse 95, Oxygen Saturation 100%, Respiration 21, Temperature 98.2 degrees F.

At 1:54 PM was the next vital signs documented in the medical record. Blood Pressure 103/59, Pulse 100, Oxygen Saturation 99, Respiration 22, and Temperature 98.8 F.

On 1/8/19 at 11:30AM, RN #20 was asked what the hospital used to identify possible blood transfusion reactions. RN #20 said, the computer notifies you anytime there is an abnormal vital sign, but I am always with my patients at the bedside, so I would recognize them.


During an interview on January 8, 2019, at 9:54 AM, the Environmental Services (EVS) Director was asked what the responsibilities were for the EVS technicians in the Emergency Department. EVS Director said the EVS staff clean counter tops, cabinets, stretchers, high dust the rooms, and sanitize all surfaces. EVS director was asked what the responsibilities were for EVS staff when they found specimens of blood, bodily fluids in the room. EVS director said they are to stop and notify the nurse. EVS staff will not clean the room until the nurse removes the blood/urine specimens. EVS said all staff had been trained on the "New" protocol about a month ago. EVS director was asked to provide documentation of the training conducted with EVS staff.

The EVS Director provided a document dated June 18, 2018, which was prior to the incident that occurred in December 3, 2018, involving Patient #27.

No documentation was provided on staff training/education for cleaning patient rooms in the emergency department.


During an interview on January 8, 2019, at 10:16 AM:

Patient Care Assistance (PCA) #1 was asked if her job duties included drawing lab specimens. PCA #1 confirmed it did. PCA #1 was asked if she had received training on drawing lab specimens. PCA #1 confirmed she had, but did not draw lab much anymore. PCA #1 said the Emergency Department now had a full time phlebotomist and they drew most of the laboratory test. PCA #1 was asked what training she had received on blood transfusions/specimen labeling in the last month. PCA #1 said she could not recall any training she had received on those subjects.


During an interview on January 8, 2019, at 11:30 PM:

RN #20 was asked what method/system the hospital used to identify possible blood transfusion reactions. RN #20 said, the computer notifies you anytime there is an abnormal vital sign, but I am always with my patients at the bedside, so I would recognize them. RN #20 said, the system also recognizes signs of sepsis and would alert you for those as well. RN #20 was asked what training on blood transfusion reactions she had received in the last month. RN #20 said, we do yearly training every year but could not remember any additional training.


During an interview on January 8, 2019, at 4:00 PM:

RN #32 was asked what vital signs were required per hospital policy on blood transfusions and where the vital signs should be documented in the record. RN #32 said, she wasn't exactly sure what the hospital policy said without looking at it but she documented every 15 minutes in the blood transfusion record. RN #32 was asked what method/system the hospital used to identify possible blood transfusion reactions. RN #32 said, the computer would alert you of the abnormal vital signs. RN #32 was asked what the policy said on possible blood transfusion reactions. RN #32 said, you would stop blood, call blood bank, call physician, fill out blood transfusion reaction form, and send blood back to lab. RN #32 was asked what training she had received on blood transfusions/ specimen labeling in the last month. RN #32 said, the staff is required to complete yearly training on blood transfusions. RN #32 was not aware of any additional training she has received on blood transfusion. RN #32 was asked if she had received any training on changes for drawing lab/labeling lab specimens in the last month. RN #32 said, she had only been there a few months so no changes had been made that she knew of since her start date. RN #32 said, she was taught to only draw the lab for the ordered test. No extra tubes were drawn. RN #32 said, the specimen tubes were required to be labeled with a lab label, not a patient label. RN #32 said the lab label printers were in the rooms.


Patient #51:

Review of the ED notes on Patient #51 revealed, she was a 73-year-old female who presented on November 28, 2018, at 12:11 PM. Patient #51 presented for fluid overload after dialysis.

Review of the ED record revealed a physician's order was written at 6:52 PM., to "Prepare RBC and platelets." There was documentation on the record that the order was discontinued at 7:01 PM. There was no order on the record for Patient #51 to be Typed and Screen for a transfusion.

Review of the hospital ED occurrences dated November 28, 2018, revealed the Transfusion Service received a request for 1 unit of Red Blood Cell and 1 unit of Platelets on the wrong patient. The blood product orders were received without a Type and Screen. The ED was called to add test and informed the order was placed on the wrong patient. The incorrect order was canceled and the correct order was placed. There was no documentation on the form as to what corrective action was implemented. Patient #'s 51 and 52 were the patients involved in the incident.

During an interview on January 9, 2019, after 9:54 a.m., RN #33 (ED Director) and RN #51 confirmed the missing information in the patient's electronic medical record. RN #51 confirmed the order was written in error on Patient #51's chart.


Patient #52:

Review of the Emergency Department (ED) notes on Patient #52 revealed, she was a 66-year-old female who presented to the ED at 2:16 PM. Patient #52 presented to the ED 2 hours after Patient #51 arrived. Patient #52 presented with abnormal laboratory values and melena (dark stools).

Review of laboratory results dated November 28, 2018, at 2:31 PM. revealed the following low results:

Hemoglobin 7.7 (reference ranges 11.2-15.7)

Hematocrit 24.2 (reference ranges 31.1-44.9)

Platelet 39 (reference ranges 150-450)


Review of a physician's history and physical dated November 28, 2018, revealed Patient #52 had diagnoses which included acute blood loss anemia and pancytopenia (low platelet level). The plan was to transfuse one unit of packed Red Blood Cells and one unit of Platelets.

At 3:58 PM, a physician's order was written to Prepare and Transfuse Leuko- Red RBC, 1 unit, and to Prepare and Transfuse Leuko- Red PLT (platelet), 1 unit.

At 3:59 PM., a physician's order was written to cancel the transfusion orders.

At 7:03 PM., (3 hours later) physician's order were rewritten to prepare and transfuse the platelets and red blood cells.

According to the Transfusion records and vital sign sheets the following was documented:

November 28, 2018:

Unit #1 Platelets started at 7:38 PM. and stopped at 8:16 PM. The Platelets infused in over 38 minutes. The physician's order did not indicate how quickly to infuse the Platelets.

Review of documentation revealed vital signs were taken at 7:37 PM., 7:52 PM., and 8:16 PM. and 8:44 PM.

The first unit of RBCs (Red Blood Cells) were started at 8:44 PM.

There was no documentation of a post vital signs documented after the completion of the platelets at 8:16 PM. and start of the Red Blood Cells at 8:44 PM.

Review of a Transfusion record dated November 29, 2018, revealed Patient #52 received another unit of packed Red Blood Cells. The unit of blood was started at 1:49 PM., stopped at 6:00 PM. and completed at 6:40 PM. (over 4.5 hours).

During an interview on January 9, 2019, after 9:54 AM., RN#33 (ED Director) and RN #51 confirmed the missing information in the chart, start times of the blood and physician orders.

During an interview on January 9, 2019, after 2:55 PM., The Quality Director provided the incident information record dated November 28, 2018, which revealed the incident was a near miss (an unplanned event that did not result in injury, illness or damage but had the potential to do so). There was no documentation as to what intervention was implemented to prevent this type of incident from occurring again.

The Quality Director was asked what was implemented and he reported that the error was caught by the laboratory and that it was just human error. The nurse put the order in the wrong patient record. He was shown the physician had put the order in. He reported the physician was notified of the order and the incident was not escalated to the Medical staff.


Patient #59:

Review of the ED notes on Patient #59 revealed, he was a 62-year-old male who presented to the ED on December 30, 2018, at 6:37 PM. Patient #59 had complaints of general weakness and a headache.

Review of a physician's history and physical dated December 30, 2018, revealed, Patient #59 had diagnoses which included colon cancer with metastasis, rectal bleeding and a hemoglobin of 4 (reference ranges being 13.7-17.5). Patient #59 was also diagnosed as being septic /hypovolemic shock.

At 8:52 PM., Patient #59 received orders to type and screen, prepare and transfuse RBC (Red Blood Cells), 3 units. According to transfusion records Unit #1 was started on December 30, 2018, at 10:51 PM.

Review of ED notes revealed the following:

At 11:08 PM, nursing documented that Patient #59 started losing consciousness.

At 11:09 PM, the blood was stopped.

At 11: 10 PM, CPR was initiated.

At 11:19 PM, Patient #59 was intubated.

At 11:29 PM, transfusion reaction investigation.

At 11:30 PM, blood bank notified of transfusion reaction ...

Review of the medication administration record dated December 30, 2018, revealed, Patient #59 received the medications magnesium sulfate and protonix during the time the blood transfusion was infusing. Nursing failed to document in the chart which intravenous access was used to give the medications, which could be potentially incompatible with the blood.

Review of documentation on the transfusion record revealed unit #1 was stopped on "01/03/19" at 8:00 AM. (4 days later).

Review of the ED record revealed Patient #59 was transferred to Intensive Care Unit (ICU) on December 31, 2018.

Review of the transfusion records revealed Patient #59 received two more units of blood.

Unit #2 was started on December 31, 2018, at 12:41 midnight and stopped at 1:13 AM.

Unit #3 was started on December 31, 2018, at 12:48 midnight and stopped at 1:13 AM.

The completion time documented on both forms was at 12:43 midnight before the