Sec. 10.10.06.05-1. Quality Control — Quality Control Program

A. Primary Standard. A licensee shall develop, establish, implement, maintain, and follow quality control policies, procedures, and techniques that ensure accurate and reliable test results and patient test reports.

B. Standard - Quality Control Program. A licensee's quality control program shall:

(1) Cover all tests and related examinations and procedures performed by the laboratory; and

(2) Meet the standards and requirements set forth in this chapter.

C. Standard - Quality Control Practices. A licensee's quality control practices shall include, but are not limited to, the use of:

(1) Analyses of reference materials to ensure that test results are:

(a) Reproducible;

(b) Accurate; and

(c) Reliable;

(2) Systems to ensure proper functioning of:

(a) Instruments;

(b) Equipment; and

(c) Reagents;

(3) Validity, calibration, and systematic procedural checks for:

(a) Reagents;

(b) Equipment; and

(c) Test systems; and

(4) Systems for:

(a) Review and reporting of test results that ensure timely error detection and correction; and

(b) Assessment of laboratory personnel:

(i) Performance;

(ii) Proficiency; and

(iii) Competency.

D. Standard - Adequacy of Methods and Equipment. A licensee shall:

(1) Employ methods and equipment that provide accurate and reliable test results and reports;

(2) Have sufficient and suitable equipment and instruments to perform the type of testing services and volume of tests offered by the laboratory;

(3) Monitor all test methods, instruments, and test systems for the following performance characteristics, when applicable:

(a) Detection limits for each:

(i) Method;

(ii) Instrument; and

(iii) Test system;

(b) Precision;

(c) Accuracy;

(d) Specificity;

(e) Sensitivity;

(f) Test interferences; and

(g) Other related test variables that affect test results;

(4) Have adequate systems in place to:

(a) Ensure that a statistically valid number of counts or measurement levels are obtained and verified to give accurate and reliable test results for systems each day instruments and equipment such as cell counters, radiation counters, and spectrophotometers are used; and

(b) Report results in an accurate and reliable manner and within the time frames established by the laboratory; and

(5) Perform test methods and use instrumentation in a manner that permits the laboratory to provide accurate and reliable test results within the laboratory's stated performance criteria.

E. Standard - Supplies, Reagents, and Materials. A licensee shall ensure that supplies, reagents, and other materials used in the collection, handling, testing, and storing of specimens in the laboratory are stored, labeled, checked for proper reactivity, and used according to §§F-I of this regulation.

F. Storage. A licensee shall ensure that laboratory materials are stored in the manner stated by the manufacturer.

G. Labeling. A licensee shall ensure that laboratory testing materials, including reagents, solutions, culture media, controls, and calibrators are labeled to indicate the:

(1) Identity;

(2) Concentration, strength, or titer;

(3) Storage requirements;

(4) Preparation and expiration dates;

(5) Identity of the preparer; and

(6) Other pertinent information that would affect test performance or outcome.

H. Reactivity Checks. A licensee shall ensure that representative samples of each lot of materials used for or in the process of testing specimens are tested on a regularly scheduled basis to determine each material's capacity to perform as required.

I. Use of Supplies and Other Materials. A licensee:

(1) May not use materials that have:

(a) Exceeded the material's expiration date;

(b) Substandard reactivity; or

(c) Deteriorated; and

(2) Shall use supplies, reagents, kits, identification systems, and other materials in a manner consistent with the recommendations and instructions provided by the manufacturer.