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Adverse reactions are an inevitable consequence of allogeneic blood product transfusions. Fortunately, as laboratories have increased the scrutiny of patient specimen identification, blood typing, and crossmatch procedures, hemolytic transfusion reactions—the most serious form of adverse reactions—have become very rare.

Laboratories are tasked with investigating and categorizing all suspected transfusion reactions. The triad of clerical check, examination for hemolysis, and repeat typing has been the standard for the investigation of a suspected hemolytic reaction for many years. However, data are lacking regarding the scope of current investigations for more recently described reaction types such as transfusion related acute lung injury (TRALI) and sepsis due to bacterial contamination. In addition, while standards require a prompt investigation, multi-institutional data regarding turnaround time for investigation and reporting are lacking.


Participation in this study will help laboratories and managers:

  • Optimize their processes for investigation and reporting of suspected transfusion reactions
  • Determine normative rates of various reaction types
  • Address applicable CAP Laboratory Accreditation Program, The Joint Commission, Clinical Laboratory Improvement Amendments (CLIA), and Association for the Advancement of Blood & Biotherapies (AABB) laboratory accreditation and regulatory requirements.*

Data Collection

Participants will prospectively record up to 50 suspected transfusion reaction events submitted to their transfusion service during a three-month study period. The type of testing performed as part of the investigation, the reaction type determined following investigation, the time of reaction report, the time of initial laboratory investigation, and the time of the final interpretive report by the pathologist will all be collected as part of the prospective aspect of the study. Laboratories will be asked to provide the total number of products transfused during the study period and annually. They will also be asked to provide the rates of specific reaction types identified during the most recent fiscal or calendar year as part of the study's retrospective aspect.

Performance Indicators

  • Rate of transfusion reaction during the study period
  • Rate of transfusion reaction during the most recent fiscal or calendar year
  • Turnaround time from report of reaction to completion of initial laboratory investigation
  • Turnaround time from report of reaction to verification of final report by pathologist

Applicable Requirements

  • CAP Laboratory Accreditation Transfusion Medicine Checklist statements including TRM.32900 (records include information about bacteriologic studies when indicated), TRM.41750 (reporting of transfusion reactions and incidents), TRM.41850 (investigation of suspected hemolytic transfusion reaction), TRM.42110 (written policies and procedures related to transfusion-related acute lung injury [TRALI])
  • The Joint Commission standards QSA.05.19.03 (EP3: laboratory evaluation of the suspected transfusion-related adverse event immediately upon notification), QSA.05.24.03, QSA.05.03.01 (EP1, EP2)
  • CLIA §493.1103(b), §493.1103(d), §493.1271(e)(1); §493.1271(b), §493.1105(a)(3)(ii)
  • AABB: standards 7.5.1 (recognition of and response to transfusion reactions) and 7.5.2 (laboratory evaluation and reporting of transfusion reactions)

Shipping Schedule

A Mailing: December 18, 2023

This is a one-time study conducted in the first quarter.

Select Q-PROBES and Q-TRACKS studies to support your quality improvement initiatives.
Anatomic Pathology
Clinical Pathology
Turnaround Time
Patient Safety
Transfusion Medicine
Chemistry/ Hematology
Customer Satisfaction
Non-Physician Care Team Satisfaction With Clinical Laboratory Services (QP231)
Technical Competency Assessment of Body Fluid Review (QPB10)
Technical Competency Assessment of Peripheral Blood Smears (QPC10/QPC25)
Technical Competency Assessment of Gram Stains (QPD10/QPD25)
Patient Identification Accuracy (QT1)
Blood Culture Contamination (QT2)
Laboratory Specimen Acceptability (QT3)
In-Date Blood Product Wastage (QT4)
Gynecologic Cytology Outcomes: Biopsy Correlation Performance (QT5)
Satisfaction with Outpatient Specimen Collection (QT7)
Stat Test Turnaround Time Outliers (QT8)
Critical Values Reporting (QT10)
Troponin Turnaround Times (QT15)
Corrected Results (QT16)
Outpatient Order Entry Errors (QT17)

*The CAP requires accredited laboratories to have a quality management plan that covers all areas of the laboratory and includes benchmarking key measures of laboratory performance (GEN.13806, GEN.20316, COM.04000). The Joint Commission requires accredited hospitals to regularly collect and analyze performance data (PI.01.01.01, PI.02.01.01). CLIA requires laboratories to monitor, assess, and correct problems identified in preanalytic, analytic, and postanalytic systems (§493.1249, §493.1289, §493.1299).

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