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Based on a review of medical records, policies and procedures, and staff interviews, it was determined that the facility failed to ensure that patient's rights were promoted and protected, and care was received in a safe setting when one (P#1) of four (P#1, P#2, P#3, and, P#4) patients reviewed was not adequately monitored for possible signs and symptoms of a blood product transfusion reaction per policy.

Cross refer to A-0398 as it relates to nursing staff failing to properly adhering to facility policy and procedures regarding blood product transfusion administration when one (P#1) of four (P#2, P#3, and P#4) patients reviewed displayed signs and symptoms reprotable per the facility's policy but was not initiated.

Findings Included:

A review of a Radiology Report dated 4/24/23 at 9:15 a.m. revealed that P#1 had right lower lobe pneumonia (an infection that affects the lungs) with associated pleural effusion (fluid buildup in the layers of tissue that line the cavity of the lung and chest).

A review of a Patient Progress Note dated 4/25/23 at 7:05 a.m. by Registered Nurse (RN) AA revealed crackles were heard bilaterally.

A review of a Documentation of Blood Transfusions dated 4/25/23 at 10:45 a.m. revealed that P#1's pre-transfusion vital signs at 10:10 a.m. were a temperature of 98.5 F, heart rate of 98, respiratory rate of 20, and a blood pressure of 129/54.

The first PRBC transfusion started at 10:10 a.m. with P#1's temperature of 98.6 F, heart rate of 103, respiratory rate of 16, and blood pressure of 135/86. RN AA documented no signs and symptoms of transfusion reaction. Continued review revealed for the next three intervals, 15 minutes apart, P#1's blood pressure increased to 145/72 at 10:55 a.m. with no signs or symptoms of transfusion reaction documented by RN AA.

Continued review revealed five intervals, 30 minutes apart of vital signs from 11:25 a.m. to 1:10 p.m. P#1's vital signs at 1:10 p.m. were a temperature of 97.8 F, heart rate of 110, respiratory rate of 18, and a blood pressure of 151/76 with no signs or symptoms of transfusion reaction noted by RN AA. The first PRBC transfusion ended at 1:10 p.m.

Continued review revealed that at 2:10 p.m., one-hour post-transfusion, P#1's vital signs were a temperature of 97.2 F, heart rate of 115, respiratory rate of 18, and a blood pressure of 177/90 with a remark by RN AA noting that P#1 tolerated the transfusion well.

A review of a document titled, "Suspected/Confirmed Transfusion Reaction", revealed selectable signs and symptoms of a reaction including, an increase or decrease in 30 mmHg or more in systolic blood pressure from initial reading along with an array of intervention choices. The document was signed by RN AA and RN BB with no selection for signs or symptoms, nor interventions.

A review of a second Documentation of Blood Transfusions dated 4/25/23 at 2:19 p.m. revealed the second PRBC transfusion was checked by RN AA and RN BB and started at 1:20 p.m. P#1's pre-transfusion vital signs were a temperature of 97.7 F, heart rate of 114, respiratory rate of 18, and a blood pressure of 152/75.

A review of a Patient Progress Note dated 4/25/23 at 3:15 p.m. by RN AA revealed that P#1 had o2 saturates in the high 60s (normal is greater than 95%), with auditory crackles heard.

Continued review revealed that at 5:40 p.m., one-hour post second transfusion, P#1's vital signs were a temperature of 98.1 F, heart rate of 108, respiratory rate of 20, and a blood pressure of 152/77 with no signs or symptoms of a transfusion reaction noted by RN AA. The second PRBC transfusion ended at 4:40 p.m.

A review of a Patient Progress Note dated 4/25/23 at 7:00 p.m. by Licensed Practical Nurse (LPN) II revealed that P#1 had intravenous (IV) fluids administered at a rate of 150 mL per hour, noted respiratory gurgles upon inhalation, with respiratory therapy at bedside.

Continued review revealed that at 9:31 p.m., P#1 was noted as pulseless and apneic (not breathing).

P#1 was pronounced deceased on 4/25/23 at 9:30 p.m. due to cardiac arrest and respiratory failure. P#1's body was released to a funeral home per family wishes.

A review of the facility's policy titled "Blood and Blood Component Administration", last reviewed 7/20/23, revealed the purpose was to ensure patient safety, quality patient care and treatment, and better patient outcomes through proper administration of blood and blood components. The patient would be monitored periodically for signs of an adverse reaction throughout the duration of the transfusion. All patients are closely monitored during the transfusion for signs of an adverse reaction, including chills, fever, rash/urticaria, pruritis, flushing, wheezing, coughing, hypoxia, dyspnea, pain, hyper or hypotension (greater than or equal to 30 mmHg systolic increase or decrease from pre-transfusion blood pressure).

Any signs of an adverse reaction would be reported to the attending physician and to the blood bank technologist. Documentation would be made of the possible reaction and of the physician and the blood bank notifications. The transfusion would be stopped, and the nurse would keep the vein open with saline. The procedure policy would be followed. The procedure outlined in the Adverse Reaction to Blood and/or Blood Component policy would be followed. A transfusion reaction workup would be performed when indicated with or without a physician's order. The Transfusion Service Director would review the transfusion reaction workup and approve the transfusion of immediate subsequent blood or blood products before signing out the subsequent blood product.

A review of the facility's policy titled "Patient Rights and Responsibilities", last reviewed 2/23, revealed the purpose would be to recognize, support, and respect each patient's right to care, treatment and services. The facility acknowledged each patient's values and their behavior toward the patient could have a profound impact on both the patient's perception of care and illness and the facility's ability to meet the patient's care needs and preferences. The patient would have the right to personal safety and security.

During an interview on 11/21/23 at 9:30 a.m. in the conference room, Registered Nurse (RN) AA said that she has been employed with the facility since 02/2023. RN AA recalled administering blood to P#1 with RN BB. RN AA said that P#1 did have a second transfusion administered and that was given right after the first transfusion ended. RN AA recalled that prior to the transfusion P#1's lung did have some crackles and she (P#1) gurgled which required the respiratory therapist to suction her. RN AA said that recently, the facility has changed the blood transfusion protocol to require nurses to wait in between multiple transfusion prior to administering the next product and provided re-education on the blood transfusion process and proper monitoring for signs and symptoms.

During an interview on 11/21/23 at 10:00 a.m. in the conference room, Lab Manager (LM) EE said that she first learned about P#1 and the transfusion after a laboratory technician performed a review of the transfusion forms that was completed by nursing staff. LM EE said that an investigation was conducted because per the policy, there was an increase of 30 mmHg in systolic blood pressure and no suspect or intervention of a transfusion reaction was identified by nursing staff or noted to the lab.

During an interview on 11/20/23 at 12:35 p.m. in the conference room with the Director of Quality (DQ) GG, she said that once leadership were made aware of the incident, a root-cause-analysis (RCA) was conducted. DQ GG said that Lab Manager (LM) EE reviewed the transfusion documentation record for the month of April and noticed that five out of 16 patients had possible signs and symptoms of a possible blood transfusion reaction that were not recognized or acted upon. DQ GG said that the result of the RCA was that there was inadequate education by nursing staff, laboratory staff, and the medical staff.

DQ GG said that the action by the facility was to update the blood transfusion policy, provide education to nursing, lab, and medical staff, and to continue to monitor future blood transfusion documentations to track future trends. DQ GG recalled that the education was provided through online modules and staff had until 1/2024 to complete it. DQ GG recalled that LM EE submitted a report of a possible transfusion related fatality to the Food and Drug Administration Department (FDA).

Based on review of medical records, policy and procedures, and staff interviews it was determined that the facility failed to adequate monitoring and reproting of potential adverse reaction was initiated when one (P#1) of four (P#1, P#2, P#3, and P#4) patients reviewed displayed signs and symptoms of a potential blood product transfusion reaction and the transfusion was not discontinued. After the first blood product tranfusion was completed and second blood product transfustion was initiated.

Cross refer to A-0144 as it relates to the facility to ensure that the patients rights are protected to receive care in a safe setting when one (P#1) of four (P#1, P#2, P#3, and P#4) patients reviewed displayed signs and symptoms of a potential blood product transfusion reaction.

Findings included:

P#1's pre-transfusion vital signs at 10:10 a.m. were a temperature of 98.5 F, heart rate of 98, respiratory rate of 20, and a blood pressure of 129/54.

Continued review revealed that at 2:10 p.m., one-hour post-transfusion, P#1's vital signs were a temperature of 97.2 F, heart rate of 115, respiratory rate of 18, and a blood pressure of 177/90 with a remark by RN AA noting that P#1 tolerated the transfusion well.

A review of a document titled, "Suspected/Confirmed Transfusion Reaction", revealed selectable signs and symptoms of a reaction including, an increase or decrease in 30 mmHg or more in systolic blood pressure from initial reading along with an array of intervention choices. The document was signed by RN AA and RN BB with no selection for signs or symptoms, nor interventions.

A review of a second Documentation of Blood Transfusions dated 4/25/23 at 2:19 p.m. revealed the second PRBC transfusion was checked by RN AA and RN BB and started at 1:20 p.m. P#1's pre-transfusion vital signs were a temperature of 97.7 F, heart rate of 114, respiratory rate of 18, and a blood pressure of 152/75.

Continued review revealed that at 5:40 p.m., one-hour post second transfusion, P#1's vital signs were a temperature of 98.1 F, heart rate of 108, respiratory rate of 20, and a blood pressure of 152/77 with no signs or symptoms of a transfusion reaction noted by RN AA. The second PRBC transfusion ended at 4:40 p.m.

A review of the facility's policy titled "Blood and Blood Component Administration", last reviewed 7/20/23, revealed the purpose was to ensure patient safety, quality patient care and treatment, and better patient outcomes through proper administration of blood and blood components. The patient would be monitored periodically for signs of an adverse reaction throughout the duration of the transfusion. All patients are closely monitored during the transfusion for signs of an adverse reaction, including chills, fever, rash/urticaria, pruritis, flushing, wheezing, coughing, hypoxia, dyspnea, pain, hyper or hypotension (greater than or equal to 30 mmHg systolic increase or decrease from pre-transfusion blood pressure).

During an interview on 11/21/23 at 9:30 a.m. in the conference room, Registered Nurse (RN) AA said that she has been employed with the facility since 02/2023. RN AA said that P#1 did have a second transfusion administered and that was given right after the first transfusion ended. RN AA recalled that prior to the transfusion P#1's lung did have some crackles and she (P#1) gurgled which required the respiratory therapist to suction her. RN AA said that recently, the facility has changed the blood transfusion protocol to require nurses to wait in between multiple transfusion prior to administering the next product and provided re-education on the blood transfusion process and proper monitoring for signs and symptoms.

During an interview on 11/21/23 at 10:00 a.m. in the conference room, Lab Manager (LM) EE said that she first learned about P#1 and the transfusion after a laboratory technician performed a review of the transfusion forms that was completed by nursing staff. LM EE said that an investigation was conducted because per the policy, there was an increase of 30 mmHg in systolic blood pressure and no suspect or intervention of a transfusion reaction was identified by nursing staff or noted to the lab.

A review of four additional patient blood transfusion documents revealed all four documents did not have one-hour post-transfusion vital signs.