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Evaluation Criteria
Proficiency testing (PT) events occur three times per year. Each event, AAFP-PT scans the Test Result Booklet pages submitted by participating labs. The data is compiled and peer group, method group and all method statistics are generated based upon:
- The peer (instrument/method), comparative method (like methods/technology) and all method groups (all labs reporting for the specimen and analyte) formed.
- A data evaluation process (statistical analysis) is performed to calculate the quantitative statistics.
- The mean, median and coefficient of variation (CV) are evaluated and outliers are removed from the data. The mean and median are compared to "closeness" in value; the lower the CV, the more "precise" or less variable the data. As a rule, outliers are data points that are less than or greater than three standard deviations from the mean.
- The acceptable range (calculated based on the grading criteria established by the CLIA regulations) and the percent consensus (number of passing labs divided by the total number of labs multiplied by 100) are then calculated.
Quantitative Analytes:
If a sufficient number of labs using the same method/instrument have reported results, then these labs are compared.
- If the peer group consensus is 80% or greater, the results are graded by the peer group statistics.
- If the peer group consensus is less than 80%, the results may be graded by either referee labs(1) or by all method statistics– provided that referee or all method statistics achieves 80% or greater consensus.
- If 80% or greater consensus is not achieved with peer, referee nor all method statistics, the results are not graded due to lack of consensus.
If there is not a sufficient number of labs using the same method reporting results, the labs are compared with either comparative method (methods determined to have the same methodology or technology) or all method statistics.
- If the comparative method group consensus is 80% or greater, the results are graded by the comparative method statistics. If the comparative method group consensus is less than 80%, the data is reviewed by the all method statistics.
- If the all method group consensus is 80% or greater, the results are graded by the all method statistics unless it is determined that the peer group values vary excessively from the all method values.
- If no comparative method group can be established and the all method group consensus is less than 80%, the results will not be graded due to lack of consensus.
If there is not a sufficient number of labs reporting at all method, the results are not graded due to no comparison group.
(1)Referee laboratory means a laboratory currently in compliance with applicable CLIA requirement, that has a record of satisfactory proficiency testing performance for all testing events for at least one year for a specific test, analyte, subspecialty or specialty and has been designated by an HHS-approved proficiency testing program as a referee laboratory for analyzing proficiency testing specimens for the purpose of determining the correct response for the specimens in a testing event for that specific test, analyte, subspecialty or specialty. (42 CFR Part 493)
Qualitative Analytes
(1)Referee laboratory means a laboratory currently in compliance with applicable CLIA requirement, that has a record of satisfactory proficiency testing performance for all testing events for at least one year for a specific test, analyte, subspecialty or specialty and has been designated by an HHS-approved proficiency testing program as a referee laboratory for analyzing proficiency testing specimens for the purpose of determining the correct response for the specimens in a testing event for that specific test, analyte, subspecialty or specialty. (42 CFR Part 493)
Qualitative Analytes
- If the total analyte consensus is 80% or greater, the results are evaluated.
- If the total analyte consensus is less than 80%, referee labs are selected. If the referee consensus is 80% or greater, results are evaluated. If the referee consensus is less than 80%, the results will not be graded due to lack of referee consensus.
- Blood bank testing requires a 95% or greater consensus of all participants or 100% of 10 or more referees in order to be graded.
Miscellaneous Grading Situations:
Occasionally, the AAFP-PT Advisory Committee determines that a particular specimen or analyte should not be graded following review of the results. Reasons may include: documented specimen problems, result variance and invalid results. The evaluations clearly state the reason for not grading the specimen or analyte.
CMS Scoring
The CMS Performance Summary provided by AAFP-PT includes the current testing event and the two previous testing events, as long as the lab has been enrolled for three consecutive events. If the lab has not been enrolled with AAFP-PT for three events, the CMS Performance Summary contains only those events in which the lab has been enrolled or participating.
The PT Evaluation Criteria for each regulated analyte is defined in the CLIA regulations. All PT providers must utilize the same criteria when evaluating PT results. Criteria for some of the tests commonly performed in POLs include:
The PT Evaluation Criteria for each regulated analyte is defined in the CLIA regulations. All PT providers must utilize the same criteria when evaluating PT results. Criteria for some of the tests commonly performed in POLs include:
| Mono, Rheumatoid Factor . . . . . . Positive or negative or . . . . . . TV +/- 2 dilutions |
Hemoglobin . . . . . . TV +/- 7% |
| Cholesterol, total . . . . . . TV +/- 10% |
Hematocrit . . . . . . TV +/- 6% |
| Creatinine 15% or . . . . . . TV +/- 3 mg/dl* |
WBC count . . . . . . TV +/- 15% |
| Glucose 10% or . . . . . . TV +/- 6 mg/dl* |
Platelet count . . . . . . TV +/- 25% |
| Potassium . . . . . . TV +/- 0.5mmol/L |
Protime . . . . . . TV +/- 15% |
| Triglycerides . . . . . . TV +/- 25% |
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Evaluation Information
