Immunohematology Proficiency Testing Program

Instructions

It is strongly recommended that testing be performed as soon as possible to allow time to request replacement specimens, if necessary. If specimens are not received within five business days of the mailout date, the specimens are received in unsatisfactory condition, or the shipment is incomplete, please contact the Immunohematology PT Program at (518) 485-5341.

The testing kit includes five whole blood specimens in CPDA-1 labeled 1-5 for ABO, Rh, Rh phenotype, direct antiglobulin testing, and compatibility testing. Five lyophilized specimens labeled 6-10 are included for laboratories that perform unexpected antibody detection, antibody identification and/or compatibility testing. The specimens were found to be negative when tested in accordance with current required blood donor screening tests, but should be handled with the same precautions that are applied to processing patient specimens, on the assumption that infectious agents may be present. Proficiency test specimens should be introduced into the routine laboratory workflow and must be tested by the same personnel and with the same frequency as routine clinical specimens.

For procedures in which a saline suspension of cells is to be used, wash a sample of red cells with saline and resuspend to the desired cell concentration. To obtain plasma for reverse testing, centrifuge the whole blood and aspirate. Do not use plasma from the whole blood specimens for unexpected antibody detection, antibody identification, and/or compatibility testing. The lyophilized specimens are provided for this purpose.

For purposes of this program, any subgroup of A other than A₁ or A₁B should be identified as A₂ or A₂B, as appropriate. For direct antiglobulin testing, report the results obtained using your primary reagent. For Rh phenotype, anti-e testing is required only if anti-E testing is positive.

For unexpected antibody detection, antibody identification and/or compatibility testing, reconstitute lyophilized specimens 6-10 by adding 3.0 mL of distilled or deionized water and mix gently. DO NOT USE PLASMA FROM THE WHOLE BLOOD SPECIMENS. For compatibility testing, specimens 1 thru 5 represent "donor blood" and specimens 6 and 7 represent "recipient serum". IMPORTANT: Specimens 1 and 2 are to be crossmatched with specimen 6, while specimens 3, 4, and 5 are to be crossmatched with specimen 7, as indicated on the results page.

Results are submitted by clicking the "Submit/Attest" button on the EPTRS Summary Page. If you are unable to access the EPTRS Summary Page, contact the Clinical Laboratory Evaluation Program (CLEP) at clepeptrs@health.state.ny.us.

The Proficiency Test results "Summary Page" must be printed and signed to attest that the Proficiency Test specimens were handled in the same manner as patient specimens, and results were entered into EPTRS accurately. The signed Summary Page should be kept at the laboratory; signatures will be verified during the next on-site survey. The Summary Page need not be submitted to the Immunohematology PT Program. The following signatures are required:

1. The Laboratory Director or the responsible Assistant Director AND
2. The Delegated Submitter (if applicable) AND
3. The Analyst(s) performing the testing.

The Close Date for submission of Proficiency Test results is provided online with each test event. Failure to submit results by midnight Eastern Time on the published Close Date will result in a score of zero and test event failure. An annual schedule of test events and Close Dates are available on the PT program website at www.wadsworth.org/labcert/clep/PT/PTschedule.htm.

If there are any questions or if extenuating circumstances prevent the timely return of results, please contact the Immunohematology PT Program at (518) 485-5341 prior to the submission deadline.