Immunohematology Proficiency Testing Program

General Information

A New York State permit is required to perform immunohematology testing on specimens originating in New York State. The Immunohematology Proficiency Testing Program monitors the quality of such testing. Oversight is authorized by NYS Public Health Law (Article 5, Title V) and the Clinical Laboratory Improvement Amendments of 1988. The Program evaluates the proficiency test results from approximately 300 laboratories and assists laboratories with unsatisfactory performance in developing appropriate corrective actions. Staff occasionally conducts on-site investigations. Enforcement action may be initiated when indicated.

Laboratories must participate in proficiency testing for each category and analyte for which the laboratory seeks or currently holds a permit. Proficiency test specimens should be introduced into the routine workflow of the laboratory and analyzed using procedures that are routinely employed for clinical specimens.

Proficiency testing kits are mailed three times per year to participating laboratories. The testing kit includes five "whole blood" specimens for ABO, Subgroups of A, Rh, Rh phenotype, direct antiglobulin test (DAT), unexpected antibody detection, antibody identification and compatibility testing, if performed. One additional "whole blood" specimen is provided as the "blood unit" for laboratories that perform compatibility testing. Information regarding the Electronic Proficiency Test Reporting System is available at www.wadsworth.org/labcert/clep/PT/eptrs.htm.

New laboratories entering the program must successfully complete one test event as well as an on-site inspection before a permit is issued.