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4455 EDISON LAKES PKWY

MISHAWAKA, IN 46545

ORDERS FOR DRUGS AND BIOLOGICALS

Tag No.: A0409

Based on policy and procedure review, medical record review, and staff interview, the facility failed to ensure blood transfusions were administered in accordance with approved medical staff policies and procedures for 4 of 4 (N10, N11, N12 and N13) closed patient medical records reviewed.

Findings:

1. Policy No. II-C.7, titled "Blood Administration" was reviewed on 11/14/12 at approximately 1:30 PM, and indicated:
A. on pg. 1, under Policy Statement section, "All administration of blood or blood products will be documented by RN (Registered Nurse) after informed consent."
B. on pg. 3, under Procedure section, point 14(j.), "retake vital signs after 15 minutes, halfway through transfusion..."

2. Review of closed patient medical records on 11/13/12 at 3:23 PM, indicated patient:
A. N10 had a unit of packed red blood cells (PRBC) infusing that started at 1930 on 8/23/12. Vital signs were to be documented 15 minutes after infusion start, which would have been 1945. They were documented at 2000, which is 30 minutes after infusion start. Lacked documentation of vital signs halfway through transfusion.
B. N11 had a unit of packed red blood cells (PRBC) infusing:
a. that stopped at 0030 on 9/21/12. Vital signs were to be documented post transfusion, but were documented at 0015, which was 15 minutes prior to stop of transfusion. Lacked documentation of vital signs halfway through transfusion and the check box in front of "all vitals recorded on electronic record" was left blank.
b. on 9/21/12 from 0045 to 0430, lacked documentation of vital signs halfway through transfusion and the check box in front of "all vitals recorded on electronic record" was left blank.
C. N12 had a unit of packed red blood cells (PRBC) infusing:
a. on 10/12/12 from 1620 to 1945, lacked documentation of vital signs halfway through transfusion and the check box in front of "all vitals recorded on electronic record" was left blank.
b. that started at 1950 on 10/12/12. Vital signs were to be documented 15 minutes after infusion start, which would have been 2005. They were documented at 2045, which is 55 minutes after infusion start. Lacked documentation of vital signs halfway through transfusion and the check box in front of "all vitals recorded on electronic record" was left blank.
D. N13 had a unit of packed red blood cells (PRBC) infusing that started at 0940 on 9/16/12. Vital signs were to be documented 15 minutes after infusion start, which would have been 0955. They were documented at 0945, which is 5 minutes after infusion start. Lacked documentation of vital signs halfway through transfusion.

3. Personnel P12 was interviewed on 11/14/12 at approximately 10:10 AM and confirmed documentation on Blood Transfusion Record is to be legible, accurate, and complete and the above mentioned patient medical records lacked accurate documentation of vital signs as required per facility policy and procedure.