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155 MEMORIAL DRIVE

PINEHURST, NC 28374

ORDERS FOR DRUGS AND BIOLOGICALS

Tag No.: A0409

Based on hospital policy and procedure review, closed medical record review, transfusion reactions file review, and interviews with nursing staff, the hospital's nursing staff failed stop a blood transfusion according to the hospital's blood administration policy for 1 of 1 blood transfusion reaction records reviewed (patient #7).

Review of current hospital policy titled, "Blood and Blood Products Transfusion (Fresh Frozen Plasma and Cryoprecipitate, Platelets), Consent and Refusal (Policy # B.14.01, Revised 01-2010)" revealed, "... NURSING ACTION 20...Report signs and symptoms of adverse reaction to physician immediately, RATIONALE/AMPLIFICATION...20...To compare vital signs to baseline. Acute reactions may occur at any time during the transfusion ... 25. IN CASE OF SUSPECTED TRANSFUSION REACTION: A. Stop the transfusion ...C. Report reaction to the Blood Bank and the attending physician...SIGNS AND SYMPTOMS OF REACTION....Type of Reaction: FEBRILE...Signs and Symptoms/Nursing Intervention...Temperature rise greater than 1 degree Celsius (1.8 degrees Fahrenheit during or within 1 hour post-transfusion."

Review of a sampled report (patient #7) from the transfusion reactions file folder provided by administration revealed documentation (including nursing and blood bank documentation) of a reported blood transfusion reaction on 12/14/2010. Review of "Report of Suspected Adverse Transfusion Reaction" form revealed, "INSTRUCTIONS TO NURSING PERSONNEL WHEN A TRANSFUSION REACTION IS SUSPECTED...1. STOP THE TRANSFUSION..." Review of document revealed a table of recorded vital signs under three columns as follows: 1) "PATIENT VITAL SIGNS (no time indicated)" temperature = 102.3, pulse = 137, blood pressure = 112/75, 2) "BEFORE TRANSFUSION" temperature = 97.8, pulse = 79, blood pressure = 112/61, and 3) "START OF SUSPECTED REACTION" temperature = 99.4, pulse = 123, blood pressure = 127/62. Review of form revealed the "Time Transfusion Began" was 1840 on 12/14/2010 and "Time Suspected Reaction Began" was 2109 on 12/14/2010 (temperature at this time was noted as 99.4o F). Further review of documents revealed "Transfusion Information... Transfusion stopped: 12/14/2010 (at) 2225.

Closed medical record review of patient #7 revealed a 79 year-old patient admitted on 12/13/2010 with a diagnosis of "acute congestive heart failure exacerbation" and "anemia." Medical record revealed a physician order, dated 12/13/2010 at 0105, "Type, Cross and transfuse with 2 Units PRBCs (Packed Red Blood Cells)." Record review revealed the second unit of PRBCs started to infuse on 12/14/2010 at 1840 and the patient's baseline temperature was 97.8 degrees Fahrenheit (F). Medical record review revealed the patient's temperatures on 12/14/2010 (after the start of Unit #2) were 97.8o F at 1804, 97o F at 1904, 98.9o F at 2004, 99.4o F at 2104, 99.8o F at 2204, 99.8o F, at 2230, and 102.3 o F at 2330. Review of nursing flowsheet revealed the following documentation, "12/14/10 2104 ...TEMP (Temperature) 99.4...ROOM 78 DEGREES WITH 2 BLANKETS ON PATIENT. THERMOSTAT ADJUSTED DOWN, 12/14/10 2219... PATIENT STATES SHE 'IS NERVOUS THINKING ABOUT THE HEART CATH (Catheterization) TOMORROW'... 12/14/10 2230 ... TEMP 99.8... ONE BLANKET REMOVED FROM PATIENT AND THERMOSTAT ADJUSTED DOWN FURTHER. TYLENOL PO GIVEN AT 2219 ...12/14/10 2230 Procedure...COMPLETED (Transfusion stopped at 2225, one hour, 21 minutes time after suspected reaction)...12/14/10 2330 Pt (Patient) Assessment...NAUSEA... 2345... (Name), RN WITH HOSPITALIST NOTIFIED OF TEMP 102.3 AND AFIB (Afibrillation) 130-140....INFORMED TO CALL CARDIOLOGIST ASSIGNED TO PATIENT....2251 SPOKE WITH DR. (Cardiologist's name). SEE ORDERS...DR. (Cardiologist's name) STATES TEMP COULD BE REACTION TO BLOOD OR DUE TO INCREASED HEART RATE...12/15/2010 0001 BLOOD BANK NOTIFIED OF POSSIBLE REACTION..." Medical record review revealed a physician was notified of the patient's increased temperature and heart rate at 2345 (2 hours, 16 minutes after suspected transfusion reaction noted and 1 hour, 21 minutes after the transfusion ended).

Interview on 12/30/2010 at 1100 with the nurse administering the 2nd Unit of PRBCs to patient #7 on 12/14/2010 revealed, "I had never had a patient have a reaction...the room was warm and the patient had blankets on..." Interview revealed the nurse had never cared for a patient having a reaction to the administration of blood prior to this event. Interview revealed patient #7's room was warm and the nurse attributed the patient's increased temperature to the room temperature. Interview revealed, considering the patients increased temperature and heart rate; she/he should have "stopped the transfusion and notified the patient's physician earlier." Interview revealed the nurse failed to follow the hospital's policy for blood administration.