Immunohematology Proficiency Testing Program

Instructions

Specimens should be stored at 1-6°C when not in use. 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.

Laboratories must participate in proficiency testing for each category and analyte for which the laboratory seeks or currently holds a permit. The testing kit includes five whole blood specimens in CPDA-1 for ABO, Rh, Rh phenotype, direct antiglobulin testing, and compatibility testing. Five serum specimens 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 the supernatant. Do not use plasma from the whole blood specimens for unexpected antibody detection, antibody identification, and/or compatibility testing. The serum specimens are provided for this purpose.

For purposes of this program, blood of 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 phenotyping, anti-e testing is required only if anti-E testing is positive.

When entering antibody identification results in the EPTRS, line 1 is a required field; lines 2 and 3 are not required fields and should be populated only if more than one antibody is identified. Antibodies that cannot be ruled out should be entered in the column, "Other Suspected Antibodies, Not Excluded."

For compatibility testing, do not use plasma from the whole blood specimens. The first and second whole blood specimens should be crossmatched with the first serum specimen while the third, fourth and fifth whole blood specimens should be crossmatched with the second serum specimen, as indicated on the worksheet and the EPTRS 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 Testing 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.