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Immunohematology Proficiency Testing Program

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Telephone: (518) 485-5341.
Fax: (518) 485-5342.
btraxess@health.state.ny.us.

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The Program evaluates the proficiency test results for approximately 300 laboratories. Grading criteria established by CLIA Regulations, Section 493.959 are used to determine the accuracy of a laboratory’s response. The laboratory’s response for each analyte is compared to the response that reflects 100% consensus of 20 referee laboratories or = 95% of all participating laboratories, except for unexpected antibody detection and antibody identification, for which the laboratory’s response for each analyte is compared to the response that reflects = 95% consensus of 20 referee laboratories or = 95% of all participating laboratories. Referee laboratories are selected from New York State participating laboratories with consistent excellent performance.

Scoring

Number of acceptable responses for the analyte x 100
_____________________________________________

Total number of challenges for the analyte
=
Analyte score
for the testing event

Criteria for acceptable performance:

  • ABO Group - 100% accuracy
  • D (Rh0) typing - 100% accuracy
  • Unexpected antibody detection - = 90% accuracy
  • Antibody identification - = 90% accuracy
  • Compatibility testing - 100% accuracy
  • Rh phenotyping - = 80% accuracy
  • Direct Antiglobulin Test - Educational
  • Subgroups of A - Educational

Each laboratory receives a test event summary report listing the scores, by analyte, for the past three test events, and a statistical summary report listing, for each analyte, the number of participating laboratories and the number of laboratories responding correctly.

Unsatisfactory performance is the failure to attain the minimum satisfactory score for an analyte for that test event, including failure for non-participation. Laboratories are required to investigate the problem(s) that contributed to the unsatisfactory performance and implement corrective action. Laboratories may request additional test samples to use as part of the investigation. The root cause analysis and any subsequent corrective action conducted by the laboratory may be reviewed during the next on-site survey or the Department may request that documentation be submitted for review.

Unsuccessful performance of the proficiency testing program is defined as unsatisfactory performance on two of three consecutive test events.