Background/Case Studies: Blood establishments often wish to follow consensus with respect to peer facilities in quality processes. Frequently, manufacturers are asked how many correlations like-facilities perform per assay during instrument validation. A manufacturer evaluated the number of correlations performed per assay across various size and types of facilities during implementation of immunohematology instruments.
Study
Design/Methods: Retrospective review of the number of correlations performed at 190 facilities installing automated instruments was performed. Data was gathered either from the number of correlations specified in the validation plan or from final summaries prepared at the conclusion of validation. Facilities were stratified by bed size. Donor facilities and clinics were categorized as “Other”. Linear regression was performed on each assay comparing correlation numbers to bed size.
Results/Findings: Table 1 details the results of the study. Conclusions: Larger facilities performed more correlations than smaller facilities as expected. Based on the number of correlations, most emphasis was placed on type and screens during validation. Results also reveal more emphasis is placed on antibody detection than identification. Many facilities in the study were part of Integrated Delivery Network (IDN) implementations with standardized validation plans resulting in more consistency in correlation performance across varying size facilities.
Importance of research: As the exodus of tenured Blood Bankers continues to impact blood establishments, they take with them the knowledge and experience garnered in their careers. Often, this leaves new and inexperienced leaders to navigate the process of instrument validation, a process which they may not have undertaken before. This study provides insight to these individuals as to what industry consensus is so they can make informed decisions for their own facilities.
