A colleague in New England works in a hospital where they collect blood product donations. She wonders if they should be doing a Proficiency Testing survey for hemoglobin, since they are doing donor pre-testing by determining the hemoglobin on donors using a Hemocue device.

The above question was forwarded to a knowledgable individual within the Laboratory Accreditation Programs of the CAP who reported that the CAP requires laboratories doing hemoglobin or hematocrit on blood donors to participate in a CAP-approved proficiency testing program for that analyte. The CAP requires one enrollment in proficiency testing per analyte. If a laboratory is already enrolled for this analyte in a different section of their laboratory (i.e. Hematology section), they would not need to enroll separately for the blood bank. An alternate system, such as split sample testing between the two areas at least semi-annually can be used to meet the proficiency testing requirement for donor hemoglobin/hematocrit. Instrument comparison studies performed every six months to meet the checklist requirements for GEN.30050 may meet the proficiency testing requirements for the hemoglobin or hematocrit if the samples used are tested in a blind fashion. For laboratories using methods where the CAP-approved proficiency testing is not compatible, such as CuSO4, an alternate system must be established and performed at least semi-annually. Finally, it is important to understand that for a laboratory to be accredited by CAP, the CAP requirement for proficiency testing applies to all tests done under the lab's CLIA license, regardless of the CLIA complexity of the test (waived or not). Thus, if a lab is inspected and accredited by the CAP, that lab would need to do proficiency testing for a test, even if it is a waived test.

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Ira A. Shulman, MD
CBBS e-Network Forum Editor & Moderator