Section 450.720  Proficiency Survey Program

a)         The Department shall require the "demonstration of proficiency" in the performance of each test offered by licensed or permitted clinical laboratories by means of State-operated or State-approved proficiency testing programs. The Department may exclude some specific tests from this requirement.

b)         Requirements for Testing Service Approval

1)         The State-approved proficiency testing service must cover all clinical laboratory and anatomical pathology specialties and subspecialties in which the laboratory performs tests as they are made available and are proven feasible for proficiency testing. One or more proficiency testing programs can be utilized to address all tests conducted by a laboratory.

2)         The approved proficiency testing service must provide to the Department an annual list of subscribers among Illinois laboratories authorizing the proficiency testing service to report their proficiency test results to the Department.

3)         The approved proficiency testing service must supply exception reports (cumulative survey management reports-cumulative deviancy reports) covering at least the immediately previous two years of testing and documenting the unsatisfactory results during that minimum two year period.  This report must be continuously updated with each new testing period and must be made available to both the participating laboratory and to the Department after each testing period.

4)         The approved proficiency testing service must provide at least the following statistical parameters:  mean or median, standard deviation or coefficient of variation, and some discussion and/or indication of accuracy and precision.

5)         The approved proficiency testing service must document, in writing, the bases for establishing acceptable limits of performance.  This documentation must be supplied to the Department and to each participating laboratory at least annually and must cover each test for which proficiency testing is provided.  The yearly revision must include all changes made in the criteria for acceptable performance which are to prevail for the ensuing year.

c)         A list of the State-approved proficiency testing programs may be obtained from the Department.

d)         The costs of such State-approved proficiency testing shall be borne by the laboratory.

e)         The laboratory shall keep on file a copy of the results of proficiency testing for review by the State laboratory evaluator.

f)          Requirements for Laboratory Testing

1)         The participating laboratory must test applicable materials each time they are distributed by the approved proficiency testing service according to a schedule approved by the Department.

2)         Those procedures performed by the laboratory for which test materials are provided by the approved proficiency testing service and which are not excluded by the Department from the "demonstration of proficiency" requirement must be proficiency tested by the participating laboratory each time test materials are received.

3)         The participating laboratory must authorize the approved proficiency testing service to report proficiency test results to the Department.

4)         The participating laboratory must test applicable materials only in the laboratory to which the license and the proficiency testing requirement applies using personnel and equipment used in that facility in providing services.

5)         A laboratory shall be required to discontinue providing a service in a procedure or category of procedures (hematology, chemistry, bacteriology-mycology, parasitology, immunology-serology, immunohematology, etc.) if:

A)        For three consecutive testing periods the laboratory fails to report on test materials received for procedures for which the laboratory is required to be proficiency tested; or

B)        For three consecutive testing periods the laboratory demonstrates unsatisfactory performance in a procedure or category of procedures.  A determination of satisfactory performance for a procedure for a testing period shall be based upon all results being within acceptable limits established by the proficiency testing service for that procedure and approved by the Department. A determination of satisfactory performance for a category of procedures shall be based upon 75% or more of the results in that category over three consecutive testing periods being within acceptable limits established by the Department.

6)         A laboratory whose services have been disapproved because of unsatisfactory performance shall be reapproved by the Department to provide these services after meeting one of the following conditions, provided that proficiency testing is the only problem preventing reapproval.

A)        The laboratory results for an unsatisfactory discontinued procedure shall be within acceptable limits established by the proficiency testing service for two consecutive testing periods subsequent to the testing periods which resulted in the discontinuance of the procedure.  The laboratory results for a disapproved category of procedures shall have 75% or more of the results within acceptable limits established by the proficiency testing service for two consecutive testing periods subsequent to the testing periods which resulted in discontinuance of the category of procedures.

B)        On-site-Testing

i)          The laboratory director may request the Department to provide proficiency testing specimens for purposes of retesting. The cost of such proficiency testing specimens shall be borne wholly by the laboratory.  The Department shall ship or cause to be shipped, hand carry or otherwise convey to the laboratory such proficiency testing specimens within three weeks after receipt of such request.  The Department shall provide an on site visit by a laboratory evaluator for the purpose of determining deficiency correction.

ii)         Successful analysis (100% of specific analysis or 75% of the results of a category are within acceptable limits as established by the testing service) shall be based upon test results of specimens similar in number and purpose to those normally received by the laboratory where performance has been judged unsatisfactory.

iii)         Successful analysis and site visit findings shall be used to reapprove either a category of procedures or a given procedure.

g)         Renewal of a license or permit may be denied for failure to maintain an acceptable standard of proficiency in the program and services provided by a laboratory.

(Source:  Amended at 13 Ill. Reg. 11573, effective July 1, 1989)