§ 493.941 Hematology (including routine hematology and coagulation).

(a) Program content and frequency of challenge. To be approved for proficiency testing for hematology, a program must provide a minimum of five samples per testing event. There must be at least three testing events at approximately equal intervals per year. The annual program must provide samples that cover the full range of values that would be expected in patient specimens. The samples may be provided through mailed shipments or, at HHS' option, may be provided to HHS and or its designee for on-site testing.

(b) Challenges per testing event. The minimum number of challenges per testing event a program must provide for each analyte or test procedure is five.