§ 493.915 Mycology. ( a ) *Program content and frequency of challenge.* To be approved for proficiency testing for mycology, the annual program must provide a minimum of five samples per testing event. There must be at least three testing events provided to the laboratory at approximately equal intervals per year. The samples may be provided through mailed shipments. The specific organisms included in the samples may vary from year to year. ( 1 ) The annual program must include, as applicable, samples for: ( i ) Direct fungal antigen detection; and
( ii ) Detection and identification of fungi and aerobic actinomycetes which includes one of the following: ( A ) Detection of the presence or absence of fungi and aerobic actinomycetes without identification; or
( B ) Identification of fungi and aerobic actinomycetes.
( 2 ) An approved program must furnish HHS and its agents with a description of the samples it plans to include in its annual program no later than 6 months before each calendar year. At least 25 percent of the samples must be mixtures of the principal organism and appropriate normal background flora. The program must include fungi and aerobic actinomycetes commonly occurring in patient specimens and other important emerging fungi. The program determines the reportable isolates and correct responses.
( 3 ) The content of an approved program must vary over time, as appropriate. The fungi included annually must contain species representative of the following major groups of medically important fungi and aerobic actinomycetes, if appropriate for the sample sources: ( i ) Yeast or yeast-like organisms;
( ii ) Molds that include; ( A ) Dematiaceous fungi;
( B ) Dermatophytes;
( C ) Hyaline hyphomycetes;
( D ) Mucormycetes; and
( iii ) Aerobic actinomycetes.
( b ) *Evaluation of a laboratory's performance.* HHS approves only those programs that assess the accuracy of a laboratory's response, in accordance with paragraphs (b)(1) through (6) of this section. ( 1 ) The program determines the reportable fungi to be reported by direct fungal antigen detection, detection of the presence or absence of fungi and aerobic actinomycetes without identification, and identification of fungi and aerobic actinomycetes. To determine the accuracy of a laboratory's responses, the program must compare each response with the response reflects agreement of either 80 percent or more of 10 or more referee laboratories or 80 percent or more of all participating laboratories. Both methods must be attempted before the program can choose to not grade a PT sample.
( 2 ) A laboratory must detect and identify the organisms to highest level that the laboratory reports results on patient specimens.
( 3 ) A laboratory's performance will be evaluated on the basis of the average of its scores for paragraphs (b)(4) through (5) of this section as determined in paragraph (b)(6) of this section.
( 4 ) The performance criterion for direct fungal antigen detection is the presence or absence of the fungal antigen. The score is the number of correct responses divided by the number of samples to be tested, multiplied by 100.
( 5 ) The performance criterion for the detection and identification of fungi and aerobic actinomycetes includes one of the following: ( i ) The performance criterion for the detection of the presence or absence of fungi and aerobic actinomycetes without identification is the correct detection of the presence or absence of fungi and aerobic actinomycetes without identification. The score is the number of correct responses divided by the number of samples to be tested multiplied by 100.
( ii ) The performance criterion for the identification of fungi and aerobic actinomycetes is the total number of correct responses for fungal and aerobic actinomycetes identification submitted by the laboratory divided by the number of organisms present plus the number of incorrect organisms reported by the laboratory multiplied by 100 to establish a score for each sample in each testing event. Since laboratories may incorrectly report the presence of fungi and aerobic actinomycetes in addition to the correctly identified principal organism(s), the scoring system must provide a means of deducting credit for additional erroneous organisms that are reported. For example, if a sample contained one principal organism and the laboratory reported it correctly but reported the presence of an additional organism, which was not considered reportable, the sample grade would be 1/(1+1) × 100 = 50 percent.
( 6 ) The score for a testing event is the average of the sample scores as determined under paragraphs (b)(4) through (5) of this section.
[87 FR 41235, July 11, 2022]