The impact of discontinuation of 7‐day storage of apheresis platelets (PASSPORT) on recipient safety: an illustration of the need for proper risk assessments
Bibliographic record
Abstract
BACKGROUND: Seven-day stored apheresis platelets (APs) were withdrawn from the US market after detection of two culture-positive units from 2571 tested at outdate in the PASSPORT surveillance study. The impact of this discontinuation on recipient safety was explored using mathematical modeling. STUDY DESIGN AND METHODS: Risk models for septic transfusion reactions (STRs) and transfusion-related acute lung injury (TRALI) were developed. Key assumptions were 400,000 annual APs transfused, equivalent STR risk for platelets (PLTs) stored for 5 days or more and zero for PLTs stored for less than 5 days, whole blood-derived PLTs (WBplts) administered in 5-unit pools, a 4.6-fold higher risk of false-negatives with surrogate versus culture-based bacterial testing, an AP TRALI risk between 1 per 1000 and 1 per 10,000, and a delay in TRALI risk reduction implementation in some centers by 6 to 12 months due to limited PLT availability. RESULTS: STR risk could increase, decrease, or remain the same depending on the percentage of inventory replaced by surrogate-tested WBplts versus culture-tested apheresis or whole blood PLTs. A delay in TRALI risk reduction implementation is likely to result in a comparable or greater risk during the delayed implementation period than the safety achieved with regard to STRs, even in the most favorable case scenario. CONCLUSION: A comprehensive risk assessment should have been conducted before the decision to discontinue PASSPORT. Risk assessments using accepted methods (and actual data when available) should precede any major blood safety decisions.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".