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UPMC PRESBYTERIAN SHADYSIDE 200 LOTHROP STREET PITTSBURGH, PA 15213 March 14, 2016
VIOLATION: QAPI Tag No: A0263
Based on a review of facility documents and policy and medical records (MR), and staff interviews (EMP), it was determined that the facility failed to implement and maintain an effective, ongoing hospital-wide quality assessment and performance improvement program for a medical error.



Findings include:



Review of the facility's "Performance Improvement Plan Fiscal Year 2015" revealed, "...Prioritizing Leadership sets process improvement priorities based on: .. information on the occurrence of serious and sentinel events; ... Statistical Tools and Techniques ... Understanding variations and their causes helps the organization focus on making process changes and improvements that would result in better outcomes and thus, reducing the risk of sentinel events and serious adverse events, improving patient safety, and improving the quality of care, treatment, and services ... Intense Analysis ..In addition to intense analysis for sentinel and serious events, undesirable patterns or trends in performance are analyzed under the following conditions: ... for use of blood or blood products."



Review of the facility's "UPMC Hospital Division Patient Safety Plan 2015" revealed, "....M. Serious Event: ...IV Authority and Responsibility: ... C. Patient Safety officer: The Patient Safety Officer shall be that individual designated by each Hospital's Chief Executive Office to be responsible to coordinate the patient Safety Program and to carry out specific aspects of the Program. ... Overseeing and ensuring the reasonable investigations of Reportable Patient Events ... Analyzing investigations of Reportable Patient Events and taking such action as is immediately necessary to ensure patient safety."


Review of facility documents revealed a Serious Event that occurred on March 6, 2016, and reported to the Department on March 11, 2016.


1. Review of MR1 on March 14, 2016, revealed, "CCM History and Physical... March 06, 3:04 AM ...Addendum by... March 06, 6:47 AM ... Patient required massive transfusion. After [patient] had received 5UPRBC (Units of Packed Red Blood Cells) and 5FFP (Fresh Frozen Plasma), it was noticed by the nursing staff that there was a FFP tag present with a different name. Bedside nurses found empty FFP bag and confirmed that it had been transfused into the wrong patient."

2. Review of facility document "Initial Incident/Event Report ... Date of Event: 03/06/2016 Date Reported: 03/06/2016 ... Event Description: ... Follow-up: 3/8 To be discussed 3/10 at Pt. (Patient) Safety (four days after the incident occurred)." No action was immediately taken to ensure patient safety as per facility Patient Safety Plan.

3. Interview with EMP1 on March 11, 2016, at approximate 1:30 PM revealed "An RCA (Root Cause Analyses) will take place with those directly involved with the event, members of the leadership team, Patient Safety, Blood Bank, Risk Management, and Education ... Date to be determined: the week of March 14, 2016 (eight days after the event occurred)."

4. Interview with EMP4 on March 11, 2016, at approximately 1:45 PM (five days after the incident occurred) revealed, "I spoke with pretty much everyone that worked that night except the HUC (Health Unit Coordinator) - the person who took the blood into the room." Further interview when asked if there was documentation of the discussion/training, EMP4 indicated, "No, I didn't make it formal, because I knew there would be a root cause analysis of the event completed by the end of next week."

5. Interview with EMP6 on March 11, 2016, at approximately 3:40 PM revealed "I think [EMP2 and EMP4] were incorrect, I believe the Assistant manager of the unit spoke with the person who made the error."

6. Interview with EMP7 on March 14, 2016, at approximately 10:30 AM (eight days after the incident occurred) revealed, "Someone brought plasma in the room and [the nurse] hung it. I discussed it with the nurses and PCT's (Patient Care Technician) and the staff involved. The two PCT's denied taking it [blood product] in the room. There is a potential that someone else could have brought it in" When asked if EMP7 had documentation of the investigation, EMP7 stated, "No."

7. Interview with EMP5 on March 14, 2016, at approximately 9:15 AM revealed, "The staff got the (emergency) cooler [to use for MR1]. We use it for the Massive Transfusion protocol."

8. During a review of the facility's policy "Patient Transfusion Services Blood Product Transfusion Therapy (Blood Bank)" with EMP10 on March 14, 2016, at approximately 10:10 AM, EMP10 revealed, "Yes, we do have a cooler for Massive Transfusion. It has multiple types of blood products in it ... I printed you off the history." When asked for the documentation to verify that the emergency cooler was used for MR1, EMP10 stated, "I'm not sure, I will have to check again."

9. During the interview on March 14, 2016, at approximately 10:15AM, EMP2 and EMP12 indicated that the blood products were used for MR1 from the emergency cooler.

10. Interview with EMP1 on March 14, 2016, at approximately 10:30 AM revealed "I am not sure what information we can give you, our investigation is not completed. We are having a RCA on this today at 11:00AM and [facility staff being interviewed] need to attend it."

11. Further interview with EMP10 on March 14, 2016, at approximately 1:15 PM revealed that previous statements made by the facility were inaccurate, as EMP10 stated, "The cooler was not used. The products were sent up through the tube."

Upon investigation, it was determined that the facility staff had not implemented or analyzed the medical error or the related indicators upon the discovery of error.
VIOLATION: BLOOD TRANSFUSIONS AND IV MEDICATIONS Tag No: A0409
Based on a review of facility policy and facility documents, medical records (MR) and staff interview (EMP), it was determined that the facility failed to ensure a blood transfusion was administered in accordance with State law and approved medical staff policies and procedures for two of two medical records reviewed (MR1 and MR2).


Findings include:


Review of the facility policy and procedure "Patient Transfusion Services Blood Product Transfusion Therapy" dated September 9, 2015, revealed "II When blood product is available: ... 4. When the blood product is received on a unit. a. Verify that the patient name and ID number on the product ID tag matches the Patient Identification Form (PIF) and that the product matches the order to transfuse including all special product requests. Visually observe for any leaks, discoloration or gross clots. Send the completed PIF back to Transfusion Service via Pneumatic Tube System within 5 minutes of receipt...5. Two individuals will review and verify the information."


1. Review of MR1 on March 14, 2016, revealed "CCM History and Physical...March 06, 3:04 AM ...Addendum by... March 06, 6:47 AM ... Patient required massive transfusion. After [patient] had received 5UPRBC (Unit of Packed Red Blood Cells) and 5FFP (Fresh Frozen Plasma), it was noticed by the nursing staff that there was a FFP tag present with a different name. Bedside nurses found empty FFP bag and confirmed that it had been transfused into the wrong patient."

Continued review of MR1 revealed that the nurses failed to verify the patients name and ID number prior to administering the blood product.

2. Review of MR2 on March 14, 2016, at approximately 1:00 PM revealed a form that was not completed by the staff who received the blood product from the pneumatic tube station. The form indicated, "Blood Work Communication Order Requisition Patient Identification Form Communication Requested Start Date/Time 03/06/16 5:07:00... Plasma (FFP) Quantity: 1... For unit staff receiving Blood Product from Pneumatic Tube Station. Upon Receipt of Product Immediately: 1. Deliver Product to Nurse [not signed or initialed] Correct patient Y/N [not circled] Appearance Acceptable Y/N [not circled] Receive by RN [not signed] Date and Time [not documented] 2. Return PIF to Blood Bank."

Continued review of MR2 revealed the nursing staff that received the blood product failed to immediately deliver the blood product to the nurse.

Interview with EMP4 on March 14, 2016, at approximately 9:30 AM confirmed the above findings and revealed "The blood products where checked from the cooler, and placed on the WOW (work station on wheels). The nurse left the room to get more tubing when the PCT (patient care technician) brought it [blood product] in and placed it on top of the already verified bags. When they were finished they were reviewing the tags and realized one had a different patient name."