10.10.05.01

.01 Participation and Evaluation.

A. Participation. A licensee operating under a permit shall ensure that the laboratory:

(1) Enrolls in and participates satisfactorily in a PT program that meets the criteria set forth in this chapter for each of the tests that the laboratory offers to perform or performs;

(2) Tests PT samples in the same manner and number of times that it routinely tests patient specimens; and

(3) Complies with the applicable standards contained in 42 CFR §§493.801—493.807.

B. Evaluation — General. When a PT program does not evaluate a participating laboratory's PT results or the evaluated PT results are inconsistent with satisfactory performance, the participating laboratory and the OHCQ shall evaluate the PT results by comparing them to the all-method-results mean, all-instrument-results mean, or the all-participant-results mean found in the PT program's summaries of PT results.

C. Evaluation — Departmental.

(1) Administrative Procedures.

(a) Submission of Results. The OHCQ shall monitor for regulatory purposes only official results sent directly from the PT program.

(b) Multiple Programs. If a licensee enrolls in more than one PT program and duplicate testing and reporting occurs, the licensee shall notify the OHCQ which PT program is to be scored for regulatory purposes.

(c) Sample Testing. A licensee shall operate under the following PT procedures:

(i) PT samples shall be tested each time a shipment is received and for only those procedures offered or allowed under a laboratory's license;

(ii) If a test is no longer offered or performed, the licensee shall inform the OHCQ in writing;

(iii) PT samples shall be tested only in the laboratory for which they are intended;

(iv) PT samples shall be handled, processed, and tested in the same manner as patient specimens; and

(v) Repeat testing may not be performed on PT samples unless it is the laboratory's policy to test patients in duplicate or if abnormal test results are routinely repeated to verify accuracy.

(d) Testing and Reporting Deadlines.

(i) A licensee shall test PT samples and report PT results within the time limits set by the PT program.

(ii) PT results submitted late by a licensee are deemed unsatisfactory by the PT program and the OHCQ.

(e) PT Program Evaluation Errors. A licensee is responsible for seeing that an evaluation error on the PT report is corrected by the PT program and that the program sends a corrected PT report to the OHCQ.

(f) Performance Records. A laboratory's marginal or unsatisfactory PT performance may not be changed to reflect satisfactory performance when:

(i) PT results are not submitted;

(ii) PT results are submitted after the due date; or

(iii) Transcription errors involving PT results went unnoticed until the evaluated results were scored.

(2) Evaluation Procedures.

(a) Grading Criteria.

(i) The PT program shall score test results in terms of correlation with reference or referee laboratory test results, target values, or statistical methods based on means and standard deviations.

(ii) The OHCQ shall determine a laboratory's PT performance based on a PT program's numerical score for each specialty, subspecialty, constituent, analyte, and culture type.

(b) Scores. Numerical PT scores required for satisfactory performance in each subdiscipline, specialty or subspecialty are as follows:

(i) AFP for NTD, equal to or greater than 80 percent;

(ii) Antibodies for HIV, equal to or greater than 80 percent;

(iii) Bacteriology, equal to or greater than 80 percent;

(iv) Blood gases, equal to or greater than 80 percent;

(v) Blood lead, equal to or greater than 80 percent;

(vi) Chemistry, equal to or greater than 80 percent;

(vii) Coagulation, equal to or greater than 80 percent;

(viii) Cytogenetics, as set by PT program;

(ix) Drugs of abuse, forensic, equal to or greater than 90 percent;

(x) Drugs of abuse, clinical or diagnostic, equal to or greater than 80 percent;

(xi) Hematology, equal to or greater than 80 percent;

(xii) Immunohematology, ABO and Rh typing, antibody screen, 100 percent;

(xiii) Immunohematology, antibody identification, equal to or greater than 90 percent;

(xiv) Mycology, equal to or greater than 80 percent;

(xv) Mycobacteriology, equal to or greater than 80 percent;

(xvi) Immunology, nonsyphilis serology, equal to or greater than 80 percent;

(xvii) Parasitology, equal to or greater than 80 percent;

(xviii) Syphilis serology, equal to or greater than 80 percent; and

(xix) Urinalysis, equal to or greater than 80 percent.

(c) Scoring Criteria. A percent score is derived by dividing the number of satisfactory PT results by the total number of PT results for each subdiscipline, specialty, subspecialty, or individual constituent or analyte within a subspecialty.

(d) PT Failure. PT scores lower than the percent scores listed in §C(2)(b) of this regulation are failing scores.

(e) Evaluated PT Results. PT results evaluated in determining PT performance include PT results not evaluated by the PT program, code 10 results, for example, 10E, 10G, 10T, and codes of tests not performed.

(3) Initial or Single PT Failure.

(a) Licensee Action. A licensee shall investigate a single or initial PT failure and document the corrective action taken.

(b) Departmental Procedures. The OHCQ shall document an initial or single PT failure and may request a licensee to submit a plan of correction and supporting documentation related to the failure.

(4) Marginal PT Performance.

(a) Test Scores. PT performance is marginal when a laboratory exhibits failing PT scores in two of three consecutive testing events in a subdiscipline, specialty, subspecialty, or individual constituent or analyte, for example, Na, RBC, cholesterol.

(b) Departmental Procedures. The OHCQ shall:

(i) Document the marginal PT;

(ii) Send written notice of the marginal PT to the licensee; and

(iii) Request the licensee to submit a written plan of correction.

(c) Laboratory Actions. A licensee shall submit to the OHCQ a written plan of correction that describes the investigation and steps taken to improve the applicable test performance.

(5) Unsatisfactory PT Performance. PT performance is unsatisfactory when a laboratory exhibits:

(a) Failing PT scores in three of four consecutive testing events in a subdiscipline, specialty, or individual constituent or analyte, for example, Na, RBC, cholesterol;

(b) Failing PT scores in two of three consecutive testing events in a subdiscipline, specialty, subspecialty, or individual constituent or analyte, for example, Na, RBC, cholesterol, and the next PT report for the test states "test not performed"; or

(c) An average PT score for a test over the last four consecutive testing events that falls below the minimum percent score set forth in §C(2)(b) of this regulation.