§ 493.915 - Mycology.

§ 493.915 Mycology.

Cross Reference

Link to an amendment published at 87 FR 41235, July 11, 2022.

(a) Types of services offered by laboratories. In mycology, there are four types of laboratories for proficiency testing purposes that may perform different levels of service for yeasts, dimorphic fungi, dermatophytes, and aerobic actinomycetes:

(1) Those that isolate and identify only yeasts and/or dermatophytes to the genus level;

(2) Those that isolate and identify yeasts and/or dermatophytes to the species level;

(3) Those that isolate and perform identification of all organisms to the genus level; and

(4) Those that isolate and perform identification of all organisms to the species level.

(b)

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

or, at HHS' option, may be provided to HHS or its designee for on-site testing. An

. The specific organisms included in the samples may vary from year to year.

(1) The annual program must include

samples that contain organisms that are representative of five major groups of fungi: Yeast or yeast-like fungi; dimorphic fungi; dematiaceous fungi; dermatophytes; and saprophytes, including opportunistic fungi. The specific fungi included in the samples may vary from year to year.(1) An approved program must, before each calendar year, furnish HHS with a description of samples that

, 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

six

6 months before each calendar year. At least

50

25 percent of the samples must be mixtures of the principal organism and appropriate normal background flora.

Other important emerging pathogens (as determined by HHS) and organisms

The program must include fungi and aerobic actinomycetes commonly occurring in patient specimens

must be included periodically in the program.

(2) An approved program may vary over time. As an example, the types of organisms that might be included in an approved program over time are—

Candida albicans

Candida (other species)

Cryptococcus neoformans

Sporothrix schenckii

Exophiala jeanselmei

Fonsecaea pedrosoi

Microsporum sp.

Acremonium sp.

Trichophvton sp.

Aspergillus fumigatus

Nocardia sp.

Blastomyces dermatitidis¹

Zygomycetes sp.

¹ Note: Provided as a nonviable sample.

(c

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 (

c

b)(1) through (

5

6) of this section.

(1) The program determines the reportable

organisms

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

response

responses, the program must compare

the laboratory's response for each sample

each response with the response

that

reflects agreement of either 80 percent or more of

ten

10 or more referee laboratories or 80 percent or more of all participating laboratories.

(2) To evaluate a laboratory's response for a particular sample, the program must determine a laboratory's type of service in accordance with paragraph (a) of this section. A laboratory must isolate

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

the same extent it performs these procedures

highest level that the laboratory reports results on patient specimens.

(3)

Since laboratories may incorrectly report the presence of organisms in addition to the correctly identified principal organism(s), the grading system must deduct credit for additional erroneous organisms reported. Therefore, the total number of correct responses

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

must be

multiplied by 100 to establish a score for each sample in each

shipment or

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

present

considered reportable, the sample grade would be 1/(1+1)

x100

× 100 = 50 percent.

(

4

6) The score for

the antigen tests is the number of correct responses divided by the number of samples to be tested for the antigen, multiplied by 100.(5) The score for

a testing event is the average of the sample scores as determined under

paragraph

paragraphs (

c

b)(

3

4)

or

through (

c)(4), or both,

5) of this section.

[57 87 FR 7151, Feb. 28, 1992, as amended at 58 FR 5228, Jan. 19, 1993; 68 FR 3702, Jan. 24, 200341235, July 11, 2022]