AABB validation study of the CDC's National Healthcare Safety Network Hemovigilance Module adverse events definitions protocol.

BACKGROUND: The utility of a hemovigilance system depends on appropriate, reproducible application of system definitions. This is even more important when submissions are not reviewed by an adjudicating body. We sought to determine how participants would code adverse reactions at institutions that had or had not received training on the application of definitions used in the CDC's National Healthcare Safety Network Hemovigilance Module (HVM). STUDY DESIGN AND METHODS: Facilities that were (11) or were not (11) submitting adverse reaction data to the HVM reviewed 36 hypothetical cases containing elements of 37 case definitions from 12 different diagnostic groups. Respondents were required to determine the type of adverse event, if any, and assign a case definition (diagnostic probability), severity, and imputability using the January 2013 HVM Surveillance Protocol definitions. Those submitting HVM data had access to an instructional slide set prepared by CDC using similar hypothetical cases. Concordance with expert analysis was determined for the two groups of respondents. RESULTS: The frequencies of agreement with the expert assessment were not different according to prior training exposure in any of the diagnostic groups, and results were totaled across both groups. Response accuracy varied by type of categorization (adverse event type, 72.1%; match with case definition, 76.5%; severity, 69.6%; imputablity, 64.4%) and by type of adverse event. CONCLUSION: Despite delineated definitions, considerable variability in responses was seen, and this was not reduced by the available training. This degree of inconsistency in application of the surveillance definitions could degrade the utility of comparative reports.

Changes in hospital human tissue oversight in the United States between 2005 and 2011: results of a follow-up AABB survey.

BACKGROUND: In 2005, The Joint Commission (TJC) implemented tissue storage and issuance standards for hospital oversight, which AABB assessed by survey. This follow-up survey of AABB's membership, 6 years later, ascertained changes after TJC implementation of tissue standards. STUDY DESIGN AND METHODS: AABB's Biovigilance Tissue Working Group conducted a Web-based survey, distributed to 1069 hospital institutional members in June 2011. Human tissue types used, departmental responsibilities, and views of AABB involvement were queried. RESULTS: Of the 336 (31%) total respondents, 84% use allogeneic and/or autologous human tissue. Sixty-one percent have stored tissue on consignment. As in 2005, the department of surgery most often had responsibility for tissue use, followed by the blood bank or transfusion service (BBTS). Overall, the BBTS had a smaller role in oversight of autologous tissue acquisition in 2011 versus 2005, but no change in level of responsibility for storage or issue of tissues. Hospitals reported the BBTS and combined blood and tissue services (CBTS) added responsibilities for storing and monitoring eye tissue and heart valves (p < 0.05) since 2005. The BBTS/CBTS increased their degree of responsibility for reporting suspected postimplant infection and other adverse reactions for musculoskeletal allografts (p < 0.01), eye tissue (p < 0.005), and eye tissue recipients recall notification (p < 0.05). The BBTS/CBTS have more responsibility than any other department for stem cell and cord blood management. CONCLUSIONS: In this survey, AABB institutional members reported that BBTS are more involved than previously in the regulatory aspects of human tissue oversight and remain involved in many operational aspects of hospital tissue management.