42 C.F.R. §§ 493.911–493.919

The annual program must include, as applicable, samples for:

An approved program must furnish HHS and its agents with a description of samples that it plans to include in its annual program no later than 6 months before each calendar year. The program must include bacteria commonly occurring in patient specimens and other important emerging pathogens. The program determines the reportable isolates and correct responses for antimicrobial susceptibility testing for any designated isolate. At least 25 percent of the samples must be mixtures of the principal organism and appropriate normal flora. Mixed cultures are samples that require reporting of one or more principal pathogens. Mixed cultures are not “negative” samples such as when two commensal organisms are provided in a PT sample with the intended response of “negative” or “no pathogen present.” The program must include the following two types of samples to meet the 25 percent mixed culture criterion:

The content of an approved program must vary over time, as appropriate. The types of bacteria included annually must be representative of the following major groups of medically important aerobic and anaerobic bacteria, if appropriate for the sample sources:

For antimicrobial susceptibility testing, the program must provide at least two samples per testing event. The program must annually provide samples that include Gram-positive organisms and samples that include Gram-negative organisms that have a predetermined pattern of susceptibility or resistance to the common antimicrobial agents.

The program determines the reportable bacterial staining and morphological characteristics to be interpreted by Gram stain. The program determines the bacteria to be reported by direct bacterial antigen detection, bacterial toxin detection, detection of the presence or absence of bacteria without identification, identification of bacteria, and antimicrobial susceptibility testing. To determine the accuracy of each of the laboratory's responses, the program must compare each response with the response which 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.

A laboratory must identify the organisms to highest level that the laboratory reports results on patient specimens.

A laboratory's performance will be evaluated on the basis of the average of its scores for paragraph (b)(4) through (8) of this section as determined in paragraph (b)(9) of this section.

The performance criteria for Gram stain including bacterial morphology is staining reaction, that is, Gram positive or Gram negative and morphological description for each sample. The score is the number of correct responses for Gram stain reaction plus the number of correct responses for morphological description divided by 2 then divided by the number of samples to be tested, multiplied by 100.

The performance criterion for direct bacterial antigen detection is the presence or absence of the bacterial antigen. The score is the number of correct responses divided by the number of samples to be tested, multiplied by 100.

The performance criterion for bacterial toxin detection is the presence or absence of the bacterial toxin. The score is the number of correct responses divided by the number of samples to be tested multiplied by 100.

The performance criterion for the detection and identification of bacteria includes one of the following:

For antimicrobial susceptibility testing, a laboratory must indicate which drugs are routinely included in its test panel when testing patient samples. A laboratory's performance will be evaluated for only those antimicrobials for which susceptibility testing is routinely performed on patient specimens. A correct response for each antimicrobial will be determined as described in paragraph (b)(1) of this section. Scoring for each sample is based on the number of correct susceptibility responses reported by the laboratory divided by the actual number of correct susceptibility responses determined by the program, multiplied by 100. For example, if a laboratory offers susceptibility testing using three antimicrobial agents, and the laboratory reports correct responses for two of the three antimicrobial agents, the laboratory's grade would be 2/3 × 100 = 67 percent.

The score for a testing event in bacteriology is the average of the scores determined under paragraphs (b)(4) through (8) of this section based on the type of service offered by the laboratory.

The annual program must include, as applicable, samples for:

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 mycobacteria and appropriate normal flora. The program must include mycobacteria commonly occurring in patient specimens and other important emerging mycobacteria. The program determines the reportable isolates and correct responses.

The content of an approved program may vary over time, as appropriate. The mycobacteria included annually must contain species representative of the following major groups of medically important mycobacteria, if appropriate for the sample sources:

The program must provide at least five samples per testing event that include challenges that contain acid-fast organisms and challenges that do not contain acid-fast organisms.

The program determines the reportable mycobacteria to be detected by acid-fast stain. The program determines the mycobacteria to be reported by detection of the presence or absence of mycobacteria without identification, and identification of mycobacteria. To determine the accuracy of each of the laboratory's responses, the program must compare each response with the response that 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.

A laboratory must detect and identify the organisms to the highest level that the laboratory reports results on patient specimens.

A laboratory's performance will be evaluated on the basis of the average of its scores for paragraph (b)(4) through (5) of this section as determined in paragraph (b)(6) of this section.

The performance criterion for acid-fast stains is positive or negative or the presence or absence of acid-fast organisms. The score is the number of correct responses divided by the number of samples to be tested, multiplied by 100.

The performance criterion for the detection and identification of mycobacteria includes one of the following:

The score for a testing event in mycobacteriology is the average of the scores determined under paragraphs (b)(4) through (5) of this section based on the type of service offered by the laboratory.

The annual program must include, as applicable, samples for:

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.

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:

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.

A laboratory must detect and identify the organisms to highest level that the laboratory reports results on patient specimens.

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.

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.

The performance criterion for the detection and identification of fungi and aerobic actinomycetes includes one of the following:

The score for a testing event is the average of the sample scores as determined under paragraphs (b)(4) through (5) of this section.

The annual program must include, as applicable, samples for:

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. Samples must include both formalinized specimens and PVA (polyvinyl alcohol) fixed specimens as well as blood smears, as appropriate for a particular parasite and stage of the parasite. The majority of samples must contain protozoa or helminths or a combination of parasites. Some samples must be devoid of parasites.

The content of an approved program must vary over time, as appropriate. The types of parasites included annually must be representative of the following major groups of medically important parasites, if appropriate for the sample sources:

The program must provide at least five samples per testing event that include challenges that contain parasites and challenges that are devoid of parasites.

The program determines the reportable parasites to be detected by direct parasite antigen detection, detection of the presence or absence of parasites without identification, and identification of parasites. It may elect to establish a minimum number of parasites to be identified in samples before they are reported. Parasites found in rare numbers by referee laboratories are not considered in a laboratory's performance; such findings are neutral. To determine the accuracy of a laboratory's response, the program must compare each response with the response which 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.

A laboratory must detect and identify or concentrate and identify the parasites to the highest level that the laboratory reports results on patient specimens.

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.

The performance criterion for direct parasite antigen detection is the presence or absence of the parasite antigen. The score is the number of correct responses divided by the number of samples to be tested, multiplied by 100.

The performance criterion for the detection and identification of parasites includes one of the following:

The score for a testing event is the average of the sample scores as determined under paragraphs (b)(4) through (5) of this section.

The annual program must include, as applicable, samples for:

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. The program must include other important emerging viruses and viruses commonly occurring in patient specimens.

The content of an approved program must vary over time, as appropriate. If appropriate for the sample sources, the types of viruses included annually must be representative of the following major groups of medically important viruses:

The program determines the viruses to be reported by direct viral antigen detection, and detection and identification of viruses. To determine the accuracy of a laboratory's response, the program must compare each response with the response which 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.

A laboratory must detect and identify the viruses to the highest level that the laboratory reports results on patient specimens.

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.

The performance criterion viral antigen detection is the presence or absence of the viral antigen. The score is the number of correct responses divided by the number of samples to be tested, multiplied by 100.

The performance criterion for the detection and identification of viruses is the total number of correct responses for viral detection and identification submitted by the laboratory divided by the number of viruses present plus the number of incorrect virus 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 viruses 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.

The score for a testing event is the average of the sample scores as determined under paragraphs (b)(4) and (5) of this section.