Common Causes of Blood Transfusion Events in a University Hospital: Analysis of Incident Reports

Common Causes of Blood Transfusion Events in a University Hospital: Analysis of Incident Reports.

Inhospital the blood transfusion process consists of many phases: ordering the blood product, analysis of the blood sample, delivery, transport and storage of the blood product and administration. In each of these phases (near) accidents may occur. A severe transfusion incident refers to the transfusion of a wrong blood product, whereas a near miss is detected before transfusion.

In 2010 the University Hospitals Leuven introduced a new electronic patient incident report system for transfusion events.

In this study the investigators will analyze the reported blood transfusion events to detect the most common causes of blood transfusion events and the weakest link in the blood transfusion chain.

Study Overview

• Status: Completed
• Conditions: Blood Transfusion Events

Detailed Description

A retrospective survey will be conducted of all transfusion events reported in the University Hospitals Leuven between January 2011 and July 2012. Both severe accidents and near misses will be included.

Data will be drawn from the incident report system. Data concerning the number of transfused blood products will be required from the Medical Administration Service.

Events will be classified according to the severity and the cause of the event. The different settings where the events took place will be compared using a chi-square test (p<0,05).

• Study Type: Observational
• Enrollment (Actual): 131

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium
    • University Hospitals Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients in a university hospital which experienced a transfusion event

Description

Inclusion Criteria:

• all transfusion events reported in the University Hospitals Leuven between January 2011 and July 2012
• Both severe accidents and near misses were included

Exclusion Criteria:

• Transfusion reactions

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of inhospital blood transfusion events	included events will be classified into near misses or severe incidents	up to 1,5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Causes of inhospital blood transfusion events	Events are classified into human error, technical problems, deficiency of the blood product and others. Events will also be classified considering the phase in the blood transfusion process. Causes will be studied hospital wide and per setting were the event took place.	up to 1,5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of inhospital blood transfusion events	The number of transfusion events divided by the total number of transfused blood products in the study period	up to 1,5 years
Is there a relation between misidentification events and the setting where the event took place?	The different settings where the events took place will be compared using a chi-square test (p<0,05).	up to 1,5 years

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Study Director: Timothy Devos, MD, PhD, Department of Hematology, University Hospitals Leuven, Herestraat 49, 3000 Leuven, Belgium; Principal Investigator: Els Costermans, RN, Department of Hematology, University Hospitals Leuven, Herestraat 49, 3000 Leuven, Belgium

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (ACTUAL): February 1, 2013

Study Registration Dates

• First Submitted: February 12, 2013
• First Submitted That Met QC Criteria: March 13, 2013
• First Posted (ESTIMATE): March 18, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): March 18, 2013
• Last Update Submitted That Met QC Criteria: March 13, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: blood transfusion; adverse event; incident reporting
• Other Study ID Numbers: S55141