The subspecialties under the specialty of microbiology for which a program may offer proficiency testing are bacteriology, mycobacteriology, mycology, parasitology and virology. Specific criteria for these subspecialties are found at §§ 493.911 through 493.919.
(a) Program content and frequency of challenge. To be approved for proficiency testing for bacteriology, 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 to the laboratory 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) Gram stain including bacterial morphology;
(ii) Direct bacterial antigen detection;
(iii) Bacterial toxin detection; and,
(iv) Detection and identification of bacteria which includes one of the following:
(A) Detection of the presence or absence of bacteria without identification; or
(B) Identification of bacteria; and
(v) Antimicrobial susceptibility testing of select bacteria.
(2) 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:
(i) Samples that require laboratories to report only organisms that the testing laboratory considers to be a principal pathogen that is clearly responsible for a described illness (excluding immuno-compromised patients). The program determines the reportable isolates, including antimicrobial susceptibility for any designated isolate; and
(ii) Samples that require laboratories to report all organisms present. Samples must contain multiple organisms frequently found in specimens where multiple isolates are clearly significant or where specimens are derived from immuno-compromised patients. The program determines the reportable isolates.
(3) 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:
(i) Gram-negative bacilli.
(ii) Gram-positive bacilli.
(iii) Gram-negative cocci.
(iv) Gram-positive cocci.
(4) 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.
(b) Evaluation of a laboratory's performance. HHS approves only those programs that assess the accuracy of a laboratory's responses in accordance with paragraphs (b)(1) through (9) of this section.
(1) 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.
(2) A laboratory must 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 paragraph (b)(4) through (8) of this section as determined in paragraph (b)(9) of this section.
(4) 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.
(5) 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.
(6) 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.
(7) The performance criterion for the detection and identification of bacteria includes one of the following:
(i) The performance criterion for the detection of the presence or absence of bacteria without identification is the correct detection of the presence or absence of bacteria 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 bacteria is the total number of correct responses for bacterial 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 organisms 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.
(8) 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.
(9) 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.
[87 FR 41233, July 11, 2022]
(a) Program content and frequency of challenge. To be approved for proficiency testing for mycobacteriology, the annual program must provide a minimum of five samples per testing event. There must be at least two 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) Acid-fast stain; and
(ii) Detection and identification of mycobacteria which includes one of the following:
(A) Detection of the presence or absence of mycobacteria without identification; or
(B) Identification of mycobacteria.
(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 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.
(3) 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:
(i) Mycobacterium tuberculosis complex; and
(ii) Mycobacterium other than tuberculosis (MOTT).
(4) 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.
(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 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.
(2) A laboratory must detect and identify the organisms to the 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 paragraph (b)(4) through (5) of this section as determined in paragraph (b)(6) of this section.
(4) 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.
(5) The performance criterion for the detection and identification of mycobacteria includes one of the following:
(i) The performance criterion for the detection of the presence or absence of mycobacteria without identification is the correct detection of the presence or absence of mycobacteria 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 mycobacteria is the total number of correct responses for mycobacterial 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 mycobacteria in addition to the correctly identified principal organism(s), the scoring system must provide a means of deducting credit for additional erroneous organisms 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 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.
[87 FR 41234, July 11, 2022]
(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]
(a) Program content and frequency of challenge. To be approved for proficiency testing for parasitology, 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 parasite antigen detection; and
(ii) Detection and identification of parasites which includes one of the following:
(A) Detection of the presence or absence of parasites without identification; or
(B) Identification of parasites.
(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. 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.
(3) 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:
(i) Intestinal parasites; and
(ii) Blood and tissue parasites.
(4) The program must provide at least five samples per testing event that include challenges that contain parasites and challenges that are devoid of parasites.
(b) Evaluation of a laboratory's performance. HHS approves only those programs that assess the accuracy of a laboratory's responses in accordance with paragraphs (b)(1) through (6) of this section.
(1) 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.
(2) A laboratory must detect and identify or concentrate and identify the parasites to the 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 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.
(5) The performance criterion for the detection and identification of parasites includes one of the following:
(i) The performance criterion for the detection of the presence or absence of parasites without identification is the correct detection of the presence or absence of parasites 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 parasites is the total number of correct responses for parasite identification submitted by the laboratory divided by the number of parasites present plus the number of incorrect parasites 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 parasites 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 and not found in rare numbers by the program's referencing process. 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]
(a) Program content and frequency of challenge. To be approved for proficiency testing for virology, 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 samples may be provided to the laboratory 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) Viral antigen detection; and
(ii) Detection and identification of viruses.
(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. The program must include other important emerging viruses and viruses commonly occurring in patient specimens.
(3) 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:
(i) Respiratory viruses;
(ii) Herpes viruses;
(iii) Enterovirus; and
(iv) Intestinal viruses.
(b) Evaluation of 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 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.
(2) A laboratory must detect and identify the viruses to the 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 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.
(5) 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.
(6) The score for a testing event is the average of the sample scores as determined under paragraphs (b)(4) and (5) of this section.
[87 FR 41236, July 11, 2022]
The subspecialties under the specialty of immunology for which a program may offer proficiency testing are syphilis serology and general immunology. Specific criteria for these subspecialties are found at §§ 493.923 and 493.927.
(a) Program content and frequency of challenge. To be approved for proficiency testing for syphilis serology, 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 samples may be provided through mailed shipments. An annual program must include samples that cover the full range of reactivity from highly reactive to non-reactive.
(b) Evaluation of test performance. HHS approves only those programs that assess the accuracy of a laboratory's responses in accordance with paragraphs (b)(1) through (4) of this section.
(1) To determine the accuracy of a laboratory's response for qualitative and quantitative syphilis tests, the program must compare the laboratory's 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.
(2) For quantitative syphilis tests, the program must determine the correct response for each method by the distance of the response from the target value. After the target value has been established for each response, the appropriateness of the response must be determined by using fixed criteria. The criterion for acceptable performance for quantitative syphilis serology tests is the target value ±1 dilution.
(3) The criterion for acceptable performance for qualitative syphilis serology tests is reactive or nonreactive.
(4) To determine the overall testing event score, the number of correct responses must be averaged using the following formula:
[57 FR 7151, Feb. 28, 1992, as amended at 58 FR 5229, Jan. 19, 1993; 68 FR 3702, Jan. 24, 2003; 87 FR 41236, July 11, 2022]
(a) Program content and frequency of challenge. To be approved for proficiency testing for immunology, the annual 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 reactivity from highly reactive to nonreactive. The samples may be provided through mailed shipments.
(b) Challenges per testing event. The minimum number of challenges per testing event the program must provide for each analyte or test procedure is five. Analytes or tests for which laboratory performance is to be evaluated include:
| Alpha-l antitrypsin. |
| Alpha-fetoprotein (tumor marker). |
| Antinuclear antibody. |
| Antistreptolysin O (ASO). |
| Anti-human immunodeficiency virus (HIV). |
| Complement C3. |
| Complement C4. |
| C-reactive protein (high sensitivity). |
| HBsAg. |
| Anti-HBc. |
| HBeAg. |
| Anti-HBs. |
| Anti-HCV. |
| IgA. |
| IgG. |
| IgE. |
| IgM. |
| Infectious mononucleosis. |
| Rheumatoid factor. |
| Rubella. |
(c) Evaluation of a laboratory's analyte or test performance. HHS approves only those programs that assess the accuracy of a laboratory's responses in accordance with paragraphs (c)(1) through (5) of this section.
(1) To determine the accuracy of a laboratory's response for quantitative and qualitative immunology tests or analytes, the program must compare the laboratory's response for each analyte 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. The proficiency testing program must indicate the minimum concentration that will be considered as indicating a positive response. Both methods must be attempted before the program can choose to not grade a PT sample.
(2) For quantitative immunology analytes or tests, the program must determine the correct response for each analyte by the distance of the response from the target value. After the target value has been established for each response, the appropriateness of the response must be determined by using either fixed criteria or the number of standard deviations (SDs) the response differs from the target value.
| The criteria for acceptable performance are— Analyte or test |
Criteria for acceptable performance |
|---|---|
| Alpha-1 antitrypsin | Target value ± 20%. |
| Alpha-fetoprotein (tumor marker) | Target value ± 20%. |
| Antinuclear antibody (ANA) | Target value ±2 dilutions or positive or negative. |
| Antistreptolysin O | Target value ±2 dilutions or positive or negative. |
| Anti-Human Immunodeficiency virus (HIV) | Reactive (positive) or nonreactive (negative). |
| Complement C3 | Target value ±15%. |
| Complement C4 | Target value ±20% or ±5 mg/dL (greater). |
| C-reactive protein (HS) | Target value ±30% or ±1 mg/L (greater). |
| HBsAg | Reactive (positive) or nonreactive (negative). |
| Anti-HBc | Reactive (positive) or nonreactive (negative). |
| HBeAg | Reactive (positive) or nonreactive (negative). |
| Anti-HBs | Reactive (positive) or nonreactive (negative). |
| Anti-HCV | Reactive (positive) or nonreactive (negative). |
| IgA | Target value ±20%. |
| IgE | Target value ±20%. |
| IgG | Target value ±20%. |
| IgM | Target value ±20%. |
| Infectious mononucleosis | Target value ±2 dilutions or positive or negative. |
| Rheumatoid factor | Target value ±2 dilutions or positive or negative. |
| Rubella | Target value ±2 dilutions or positive or negative or immune or nonimmune. |
(3) The criterion for acceptable performance for qualitative general immunology tests is positive or negative.
(4) To determine the analyte testing event score, the number of acceptable analyte responses must be averaged using the following formula:
(5) To determine the overall testing event score, the number of correct responses for all analytes must be averaged using the following formula:
[57 FR 7151, Feb. 28, 1992, as amended at 58 FR 5229, Jan. 19, 1993; 68 FR 3702, Jan. 24, 2003; 87 FR 41237, July 11, 2022]
The subspecialties under the specialty of chemistry for which a proficiency testing program may offer proficiency testing are routine chemistry, endocrinology, and toxicology. Specific criteria for these subspecialties are listed in §§ 493.931 through 493.939.
(a) Program content and frequency of challenge. To be approved for proficiency testing for routine chemistry, 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 clinically relevant range of values that would be expected in patient specimens. The specimens may be provided through mailed shipments.
(b) Challenges per testing event. The minimum number of challenges per testing event a program must provide for each analyte or test procedure listed below is five serum, plasma or blood samples.
| Alanine aminotransferase (ALT/SGPT). |
| Albumin. |
| Alkaline phosphatase. |
| Amylase. |
| Aspartate aminotransferase (AST/SGOT). |
| Bilirubin, total. |
| Blood gas (pH, pO2, and pCO2). |
| B-natriuretic peptide (BNP). |
| proBNP. |
| Calcium, total. |
| Carbon dioxide. |
| Chloride. |
| Cholesterol, total. |
| Cholesterol, high density lipoprotein. |
| Cholesterol, low density lipoprotein, (direct measurement). |
| Creatine kinase (CK). |
| CK-MB isoenzymes. |
| Creatinine. |
| Ferritin. |
| Gamma glutamyl transferase. |
| Glucose (Excluding measurements on devices cleared by FDA for home use). |
| Hemoglobin A1c. |
| Iron, total. |
| Lactate dehydrogenase (LDH). |
| Magnesium. |
| Phosphorus. |
| Potassium. |
| Prostate specific antigen (PSA), total. |
| Sodium. |
| Total iron binding capacity (TIBC) (direct measurement). |
| Total Protein. |
| Triglycerides. |
| Troponin I. |
| Troponin T. |
| Urea Nitrogen. |
| Uric Acid. |
(c) Evaluation of a laboratory's analyte or test performance. HHS approves only those programs that assess the accuracy of a laboratory's responses in accordance with paragraphs (c)(1) through (5) of this section.
(1) To determine the accuracy of a laboratory's response for qualitative and quantitative chemistry tests or analytes, the program must compare the laboratory's response for each analyte 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.
(2) For quantitative chemistry tests or analytes, the program must determine the correct response for each analyte by the distance of the response from the target value. After the target value has been established for each response, the appropriateness of the response must be determined by using either fixed criteria based on the percentage difference from the target value or the number of standard deviations (SD) the response differs from the target value.
| The criteria for acceptable performance are—
Analyte or test |
Criteria for acceptable performance |
|---|---|
| Alanine aminotransferase (ALT/SGPT) | Target value ±15% or ±6 U/L (greater). |
| Albumin | Target value ±8%. |
| Alkaline phosphatase | Target value ±20%. |
| Amylase | Target value ±20%. |
| Aspartate aminotransferase (AST/SGOT) | Target value ±15% or ±6 U/L (greater). |
| Bilirubin, total | Target value ±20% or ±0.4 mg/dL (greater). |
| Blood gas pCO2 | Target value ±8% or ±5 mm Hg (greater). |
| Blood gas pO2 | Target value ±15% or ±15 mmHg (greater). |
| Blood gas pH | Target value ±0.04. |
| B-natriuretic peptide (BNP) | Target value ±30%. |
| Pro B-natriuretic peptide (proBNP) | Target value ±30%. |
| Calcium, total | Target value ±1.0 mg/dL. |
| Carbon dioxide | Target value ±20%. |
| Chloride | Target value ±5%. |
| Cholesterol, total | Target value ±10%. |
| Cholesterol, high density lipoprotein (HDL) | Target value ±20% or ±6 mg/dL (greater). |
| Cholesterol, low density lipoprotein (LDL), direct measurement | Target value ±20%. |
| Creatine kinase (CK) | Target value ±20%. |
| CK-MB isoenzymes | Target value ± 25% or ±3 ng/mL (greater) or MB elevated (presence or absence). |
| Creatinine | Target value ±10% or ±0.2 mg/dL (greater). |
| Ferritin | Target value ±20%. |
| Gamma glutamyl transferase | Target value ±15% or ±5 U/L (greater). |
| Glucose (excluding measurements devices cleared by FDA for home use.) | Target value ±8% or ±6 mg/dL (greater). |
| Hemoglobin A1c | Target value ±8%. |
| Iron, total | Target value ±15%. |
| Lactate dehydrogenase (LDH) | Target value ±15%. |
| Magnesium | Target value ±15%. |
| Phosphorus | Target value ± 10% or ±0.3 mg/dL (greater). |
| Potassium | Target value ±0.3 mmol/L. |
| Prostate Specific Antigen, total | Target value ±20% or ±0.2 ng/mL (greater). |
| Sodium | Target value ±4 mmol/L. |
| Total Iron Binding Capacity (TIBC). (direct measurement) | Target value ±20%. |
| Total Protein | Target value ±8%. |
| Triglycerides | Target value ±15%. |
| Troponin I | Target value ± 30% or ±0.9 ng/mL (greater). |
| Troponin T | Target value ±30% or ±0.2 ng/mL (greater). |
| Urea nitrogen | Target value ±9% or ±2 mg/dL (greater). |
| Uric acid | Target value ±10%. |
(3) The criterion for acceptable performance for qualitative routine chemistry tests is positive or negative.
(4) To determine the analyte testing event score, the number of acceptable analyte responses must be averaged using the following formula:
(5) To determine the overall testing event score, the number of correct responses for all analytes must be averaged using the following formula:
[57 FR 7151, Feb. 28, 1992, as amended at 68 FR 3702, Jan. 24, 2003; 87 FR 41238, July 11, 2022]
(a) Program content and frequency of challenge. To be approved for proficiency testing for endocrinology, 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 clinically relevant range of values that would be expected in patient specimens. The samples may be provided through mailed shipments.
(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 serum, plasma, blood, or urine samples.
| Cancer antigen (CA) 125. |
| Carcinoembryonic antigen (CEA). |
| Cortisol. |
| Estradiol. |
| Folate, serum. |
| Follicle stimulating hormone. |
| Free thyroxine. |
| Human chorionic gonadotropin (HCG) (excluding urine pregnancy tests done by visual color comparison categorized as waived tests). |
| Luteinizing hormone. |
| Parathyroid hormone. |
| Progesterone. |
| Prolactin. |
| Testosterone. |
| T3 Uptake. |
| Triiodothyronine. |
| Thyroid-stimulating hormone. |
| Thyroxine. |
| Vitamin B12. |
(c) Evaluation of a laboratory's analyte or test performance. HHS approves only those programs that assess the accuracy of a laboratory's responses in accordance with paragraphs (c)(1) through (5) of this section.
(1) To determine the accuracy of a laboratory's response for qualitative and quantitative endocrinology tests or analytes, a program must compare the laboratory's response for each analyte 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.
(2) For quantitative endocrinology tests or analytes, the program must determine the correct response for each analyte by the distance of the response from the target value. After the target value has been established for each response, the appropriateness of the response must be determined by using either fixed criteria based on the percentage difference from the target value or the number of standard deviations (SDs) the response differs from the target value.
| The criteria for acceptable performance are— Analyte or test |
Criteria for acceptable performance |
|---|---|
| Cancer antigen (CA) 125 | Target value ±20%. |
| Carcinoembryonic antigen (CEA) | Target value ±15% or ±1 ng/mL (greater). |
| Cortisol | Target value ±20%. |
| Estradiol | Target value ±30%. |
| Folate, serum | Target value ±30% or ±1 ng/mL (greater). |
| Follicle stimulating hormone | Target value ±18% or ±2 IU/L (greater). |
| Free thyroxine | Target value or ±15% or ±0.3 ng/dL (greater). |
| Human chorionic | Target value ±18% or ±3 |
| gonadotropin (excluding urine pregnancy tests done by visual color comparison categorized as waived tests) | mIU/mL (greater) or positive or negative. |
| Luteinizing hormone | Target value ±20%. |
| Parathyroid hormone | Target value ±30%. |
| Progesterone | Target value ±25%. |
| Prolactin | Target value ±20%. |
| Testosterone | Target value ±30% or ±20 ng/dL (greater). |
| T3 uptake | Target value ±18%. |
| Triiodothyronine | Target value ±30%. |
| Thyroid-stimulating hormone | Target value ±20% or ±0.2 mIU/L (greater). |
| Thyroxine | Target value ±20% or ±1.0 mcg/dL (greater). |
| Vitamin B12 | Target value ±25% or ±30 pg/mL (greater). |
(3) The criterion for acceptable performance for qualitative endocrinology tests is positive or negative.
(4) To determine the analyte testing event score, the number of acceptable analyte responses must be averaged using the following formula:
(5) To determine the overall testing event score, the number of correct responses for all analytes must be averaged using the following formula:
[57 FR 7151, Feb. 28, 1992, as amended at 58 FR 5229, Jan. 19, 1993; 68 FR 3702, Jan. 24, 2003; 87 FR 41239, July 11, 2022; 87 FR 68912, Nov. 17, 2022]
(a) Program content and frequency of challenge. To be approved for proficiency testing for toxicology, the annual 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 could occur in patient specimens and that cover the level of clinical significance for the particular drug. The samples may be provided through mailed shipments.
(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 serum, plasma, or blood samples.
| Acetaminophen, serum. |
| Alcohol (blood). |
| Blood lead. |
| Carbamazepine, total. |
| Digoxin, total. |
| Gentamicin. |
| Lithium. |
| Phenobarbital. |
| Phenytoin, total. |
| Salicylate. |
| Theophylline. |
| Tobramycin. |
| Valproic Acid, total. |
| Vancomycin. |
(c) Evaluation of a laboratory's analyte or test performance. HHS approves only those programs that assess the accuracy of a laboratory's responses in accordance with paragraphs (c)(1) through (4) of this section.
(1) To determine the accuracy of a laboratory's responses for quantitative toxicology tests or analytes, the program must compare the laboratory's response for each analyte 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.
(2) For quantitative toxicology tests or analytes, the program must determine the correct response for each analyte by the distance of the response from the target value. After the target value has been established for each response, the appropriateness of the response must be determined by using fixed criteria based on the percentage difference from the target value.
| The criteria for acceptable performance are— Analyte or test |
Criteria for acceptable performance |
|---|---|
| Acetaminophen | Target value ±15% or ±3 mcg/mL (greater). |
| Alcohol, blood | Target Value ±20%. |
| Blood lead | Target Value ±10% or ±2 mcg/dL (greater). |
| Carbamazepine, total | Target Value ±20% or ±1.0 mcg/mL (greater). |
| Digoxin, total | Target Value ±15% or ± 0.2 ng/mL (greater). |
| Gentamicin | Target Value ±25%. |
| Lithium | Target Value ±15% or ±0.3 mmol/L (greater). |
| Phenobarbital | Target Value ±15% or ±2 mcg/mL (greater). |
| Phenytoin total | Target Value ±15% or ± 2 mcg/mL (greater). |
| Salicylate | Target Value ±15% or ±2 mcg/mL (greater). |
| Theophylline | Target Value ±20%. |
| Tobramycin | Target Value ±20%. |
| Valproic Acid, total | Target Value ±20%. |
| Vancomycin | Target Value ±15% or ±2 mcg/mL (greater). |
(3) To determine the analyte testing event score, the number of acceptable analyte responses must be averaged using the following formula:
(4) To determine the overall testing event score, the number of correct responses for all analytes must be averaged using the following formula:
[57 FR 7151, Feb. 28, 1992, as amended at 58 FR 5229, Jan. 19, 1993; 68 FR 3702, Jan. 24, 2003; 87 FR 41240, July 11, 2022]
(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.
(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.
| Cell identification. |
| White blood cell differential. |
| Erythrocyte count. |
| Hematocrit (excluding spun microhematocrit). |
| Hemoglobin. |
| Leukocyte count. |
| Platelet count. |
| Fibrinogen. |
| Partial thromboplastin time. |
| Prothrombin time (seconds or INR). |
(c) Evaluation of a laboratory's analyte or test performance. HHS approves only those programs that assess the accuracy of a laboratory's responses in accordance with paragraphs (c) (1) through (5) of this section.
(1) To determine the accuracy of a laboratory's responses for qualitative and quantitative hematology tests or analytes, the program must compare the laboratory's response for each analyte 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.
(2) For quantitative hematology tests or analytes, the program must determine the correct response for each analyte by the distance of the response from the target value. After the target value has been established for each response, the appropriateness of the response is determined using either fixed criteria based on the percentage difference from the target value or the number of standard deviations (SD) the response differs from the target value.
| The criteria for acceptable performance are: Analyte or test |
Criteria for acceptable performance |
|---|---|
| Cell identification | 80% or greater consensus on identification. |
| White blood cell differential | Target ±3SD based on the percentage of different types of white blood cells in the samples. |
| Erythrocyte count | Target ±4%. |
| Hematocrit (Excluding spun hematocrit) | Target ±4%. |
| Hemoglobin | Target ±4%. |
| Leukocyte count | Target ±10%. |
| Platelet count | Target ±25%. |
| Fibrinogen | Target ±20%. |
| Partial thromboplastin time | Target ±15%. |
| If a laboratory reports a prothrombin time in both INR and seconds, the INR should be reported to the PT provider program. | |
| Prothrombin time (seconds or INR) | Target ±15%. |
(3) The criterion for acceptable performance for the qualitative hematology test is correct cell identification.
(4) To determine the analyte testing event score, the number of acceptable analyte responses must be averaged using the following formula:
(5) To determine the overall testing event score, the number of correct responses for all analytes must be averaged using the following formula:
[57 FR 7151, Feb. 28, 1992, as amended at 58 FR 5229, Jan. 19, 1993; 68 FR 3702, Jan. 24, 2003; 87 FR 41241, July 11, 2022]
(a) Program content and frequency of challenge.
(1) To be approved for proficiency testing for gynecologic examinations (Pap smears) in cytology, a program must provide test sets composed of 10- and 20-glass slides. Proficiency testing programs may obtain slides for test sets from cytology laboratories, provided the slides have been retained by the laboratory for the required period specified in §§ 493.1105(a)(7)(i)(A) and 493.1274(f)(2). If slide preparations are still subject to retention by the laboratory, they may be loaned to a proficiency testing program if the program provides the laboratory with documentation of the loan of the slides and ensures that slides loaned to it are retrievable upon request. Each test set must include at least one slide representing each of the response categories described in paragraph (b)(3)(ii)(A) of this section, and test sets should be comparable so that equitable testing is achieved within and between proficiency testing providers.
(2) To be approved for proficiency testing in gynecologic cytology, a program must provide announced and unannounced on-site testing for each individual at least once per year and must provide an initial retesting event for each individual within 45 days after notification of test failure and subsequent retesting events within 45 days after completion of remedial action described in § 493.855.
(b) Evaluation of an individual's performance. HHS approves only those programs that assess the accuracy of each individual's responses on both 10- and 20-slide test sets in which the slides have been referenced as specified in paragraph (b)(1) of this section.
(1) To determine the accuracy of an individual's response on a particular challenge (slide), the program must compare the individual's response for each slide preparation with the response that reflects the predetermined consensus agreement or confirmation on the diagnostic category, as described in the table in paragraph (b)(3)(ii)(A) of this section. For all slide preparations, a 100% consensus agreement among a minimum of three physicians certified in anatomic pathology is required. In addition, for premalignant and malignant slide preparations, confirmation by tissue biopsy is required either by comparison of the reported biopsy results or reevaluation of biopsy slide material by a physician certified in anatomic pathology.
(2) An individual qualified as a technical supervisor under § 493.1449(b) or (e) who routinely interprets gynecologic slide preparations only after they have been examined by a cytotechnologist can either be tested using a test set that has been screened by a cytotechnologist in the same laboratory or using a test set that has not been screened. A technical supervisor who screens and interprets slide preparations that have not been previously examined must be tested using a test set that has not been previously screened.
(3) The criteria for acceptable performance are determined by using the scoring system in paragraphs (b)(3) (i) and (ii) of this section.
(i) Each slide set must contain 10 or 20 slides with point values established for each slide preparation based on the significance of the relationship of the interpretation of the slide to a clinical condition and whether the participant in the testing event is a cytotechnologist qualified under § 493.1469 or § 493.1483 or functioning as a technical supervisor in cytology qualified under § 493.1449(b) or (e) of this part.
(ii) The scoring system rewards or penalizes the participants in proportion to the distance of their answers from the correct response or target diagnosis and the penalty or reward is weighted in proportion to the severity of the lesion.
(A) The four response categories for reporting proficiency testing results and their descriptions are as follows:
| Category | Description |
|---|---|
| A | Unsatisfactory for diagnosis due to: |
| (1) Scant cellularity. | |
| (2) Air drying. | |
| (3) Obscuring material (blood, inflammatory cells, or lubricant). | |
| B | Normal or Benign Changes—includes: |
| (1) Normal, negative or within normal limits. | |
| (2) Infection other than Human Papillomavirus (HPV) (e.g., Trichomonas vaginalis, changes or morphology consistent with Candida spp., Actinomyces spp. or Herpes simplex virus). | |
| (3) Reactive and reparative changes (e.g., inflammation, effects of chemotherapy or radiation). | |
| C | Low Grade Squamous Intraepithelial Lesion—includes: |
| (1) Cellular changes associated with HPV. | |
| (2) Mild dysplasia/CIN-1. | |
| D | High Grade Lesion and Carcinoma—includes: |
| (1) High grade squamous intraepithelial lesions which include moderate dysplasia/CIN-2 and severe dysplasia/carcinoma in-situ/CIN-3. | |
| (2) Squamous cell carcinoma. | |
| (3) Adenocarcinoma and other malignant neoplasms. |
(B) In accordance with the criteria for the scoring system, the charts in paragraphs (b)(3)(ii)(C) and (D) of this section, for technical supervisors and cytotechnologists, respectively, provide a maximum of 10 points for a correct response and a maximum of minus five (−5) points for an incorrect response on a 10-slide test set. For example, if the correct response on a slide is “high grade squamous intraepithelial lesion” (category “D” on the scoring system chart) and an examinee calls it “normal or negative” (category “B” on the scoring system chart), then the examinee's point value on that slide is calculated as minus five (−5). Each slide is scored individually in the same manner. The individual's score for the testing event is determined by adding the point value achieved for each slide preparation, dividing by the total points for the testing event and multiplying by 100.
(C) Criteria for scoring system for a 10-slide test set. (See table at paragraph (b)(3)(ii)(A) of this section for a description of the response categories.) For technical supervisors qualified under § 493.1449(b) or (e):
| Examinee's response: | A | B | C | D |
|---|---|---|---|---|
| Correct response category: | ||||
| A | 10 | 0 | 0 | 0 |
| B | 5 | 10 | 0 | 0 |
| C | 5 | 0 | 10 | 5 |
| D | 0 | −5 | 5 | 10 |
(D) Criteria for scoring system for a 10-slide test set. (See table at paragraph (b)(3)(ii)(A) of this section for a description of the response categories.) For cytotechnologists qualified under § 493.1469 or § 493.1483:
| Examinee's response: | A | B | C | D |
|---|---|---|---|---|
| Correct response category: | ||||
| A | 10 | 0 | 5 | 5 |
| B | 5 | 10 | 5 | 5 |
| C | 5 | 0 | 10 | 10 |
| D | 0 | −5 | 10 | 10 |
(E) In accordance with the criteria for the scoring system, the charts in paragraphs (b)(3)(ii)(F) and (G) of this section, for technical supervisors and cytotechnologists, respectively, provide maximums of 5 points for a correct response and minus ten (−10) points for an incorrect response on a 20-slide test set.
(F) Criteria for scoring system for a 20-slide test set. (See table at paragraph (b)(3)(ii)(A) of this section for a description of the response categories.) For technical supervisors qualified under § 493.1449(b) or (e):
| Examinee's response: | A | B | C | D |
|---|---|---|---|---|
| Correct response category: | ||||
| A | 5 | 0 | 0 | 0 |
| B | 2.5 | 5 | 0 | 0 |
| C | 2.5 | 0 | 5 | 2.5 |
| D | 0 | −10 | 2.5 | 5 |
(G) Criteria for scoring system for a 20-slide test set. (See table at (b)(3)(ii)(A) of this section for a description of the response categories.) For cytotechnologists qualified under § 493.1469 or § 493.1483:
| Examinee's response: | A | B | C | D |
|---|---|---|---|---|
| Correct response category: | ||||
| A | 5 | 0 | 2.5 | 2.5 |
| B | 2.5 | 5 | 2.5 | 2.5 |
| C | 2.5 | 0 | 5 | 5 |
| D | 0 | −10 | 5 | 5 |
[57 FR 7151, Feb. 28, 1992, as amended at 58 FR 5229, Jan. 19, 1993; 68 FR 3702, Jan. 24, 2003; 88 FR 90038, Dec. 28, 2023]
(a) Types of services offered by laboratories. In immunohematology, there are four types of laboratories for proficiency testing purposes—
(1) Those that perform ABO group and/or D (Rho) typing;
(2) Those that perform ABO group and/or D (Rho) typing, and unexpected antibody detection;
(3) Those that in addition to paragraph (a)(2) of this section perform compatibility testing; and
(4) Those that perform in addition to paragraph (a)(3) of this section antibody identification.
(b) Program content and frequency of challenge. To be approved for proficiency testing for immunohematology, 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 interpretation that would be expected in patient specimens. The samples may be provided through mailed shipments.
(c) Challenges per testing event. The minimum number of challenges per testing event a program must provide for each analyte or test procedure is five.
ABO group (excluding subgroups)
D (Rho) typing
Unexpected antibody detection
Compatibility testing
Antibody identification
(d) Evaluation of a laboratory's analyte or test performance. HHS approves only those programs that assess the accuracy of a laboratory's response in accordance with paragraphs (d)(1) through (5) of this section.
(1) To determine the accuracy of a laboratory's response, a program must compare the laboratory's response for each analyte with the response that reflects agreement of either 100 percent of 10 or more referee laboratories or 95 percent or more of all participating laboratories except for antibody identification. To determine the accuracy of a laboratory's response for antibody identification, a program must compare the laboratory's response for each analyte with the response that reflects agreement of either 95 percent or more of 10 or more referee laboratories or 95 percent or more of all participating laboratories. Both methods must be attempted before the program can choose to not grade a PT sample.
(2) Criteria for acceptable performance. The criteria for acceptable performance are—
| Analyte or test | Criteria for acceptable performance |
|---|---|
| ABO group | 100% accuracy. |
| D (Rho) typing | 100% accuracy. |
| Unexpected antibody detection | 100% accuracy. |
| Compatibility testing | 100% accuracy. |
| Antibody identification | 80%+ accuracy. |
(3) The criterion for acceptable performance for qualitative immunohematology tests is positive or negative.
(4) To determine the analyte testing event score, the number of acceptable analyte responses must be averaged using the following formula:
(5) To determine the overall testing event score, the number of correct responses for all analytes must be averaged using the following formula:
[57 FR 7151, Feb. 28, 1992, as amended at 87 FR 41242, July 11, 2022]