59A-7.029. General Quality Control Requirements  

Effective on Monday, February 27, 2017
  • 1(1) The laboratory shall establish and follow written quality control procedures for monitoring and evaluating the quality of the testing process of each method to assure the accuracy and reliability of patient test results and reports in accordance with CLIA requirements. The laboratory shall follow the manufacturers’ instructions and recommendations for instrument or test system operation and test performance if such instructions exceed requirements specified in this rule. In the event of a conflict between these rules and CLIA requirements, the more stringent requirement(s) shall prevail.

    87(2) The laboratory must utilize test methods, equipment, instrumentation, reagents, materials, and supplies that provide accurate and reliable test results and test reports as required by CLIA.

    114(a) Methodologies and equipment must be selected and testing must be performed in a manner that provides test results within the laboratory’s stated performance specifications for each test method and reflect procedures that are generally accepted by leading authorities such as the Centers for Disease Control and Prevention (CDC), CLIA recognized accreditation organizations, the American Association of Blood Banks (AABB) or other nationally recognized organizations. Documentation that the test methodologies and equipment meet the requirements of this rule must be maintained by the laboratory and available for review by the Agency.

    205(b) The laboratory must have equipment, instruments, reagents, materials, and supplies for the type and volume of services provided during the preanalytic, analytic, and postanalytic phases of testing.

    233(c) All equipment and supplies shall be in good working order, checked and calibrated for the proper performance of tests and services offered in accordance with this rule and CLIA requirements. The laboratory must, at a minimum, follow the manufacturers’ recommendations and instructions for equipment operation and document all such activities required for maintenance and operation of such equipment.

    292(d) The manufacturers’ instructions and documentation of maintenance and operation of equipment must be maintained by the laboratory and available for review by the Agency.

    317(e) Out-of-service equipment and supplies shall be clearly labeled to indicate their status.

    330(f) Expired, substandard or unusable supplies shall be promptly removed from use and clearly labeled to indicate their status. Such supplies shall be isolated from usable supplies until they are removed from the premises.

    364(g) Procedures must be approved, signed, and dated by the current laboratory director both initially and biennially thereafter.

    382(3) Quality Control Procedures. In accordance with CLIA requirements and any additional provisions of this rule, the laboratory shall perform control procedures to monitor the ability of the method or test system to give accurate, precise and reliable patient test results.

    423(a) Quantitative controls shall be of different concentrations that approximate the analytical range of that analyte, e.g., normal and abnormal patient values.

    445(b) No daily quality control testing is required for those tests listed as Provider-Performed Microscopy tests in 46242 CFR 493.19(c)(1-9), 465provided the laboratory has instituted a quality assessment program containing the elements found in Rule 48059A-7.031, 481F.A.C., Quality Assessment, to verify the accuracy of those tests at least every 6 months.

    496(c) All control procedures required above shall be documented and available to the Agency upon request.

    512(d) Use of Individualized Quality Control Plan (IQCP).

    5201. A laboratory is permitted to use IQCP testing pursuant to 53142 CFR 493.1256(d) 534provided that those electronic, procedural or internal controls or combinations thereof are met; and the following requirements are met:

    553a. The plan describes the practices, procedures, and resources needed to ensure the quality of the testing performed.

    571b. The plan evaluates and identifies the potential failures and sources of error for the preanalytic, analytic and postanalytic phases of testing as it relates to specimen, the test system, reagent, environment, and testing personnel.

    606c. The plan’s evaluation includes specific assessment and documentation of how each step of the testing process is potentially impacted by the IQCP process; and evaluates each step of the testing process for potential sources of error.

    643d. The implications of reducing the frequency of the use of external controls and the possibility of providing inaccurate and unreliable test results are evaluated, found acceptable, and approved in writing by the laboratory director.

    678e. The choice of IQCP options described in 68642 CFR 493.1256(d) 689is consistent with the extent to which the electronic, procedural or internal controls or combinations thereof ensure that the provisions of this rule are met.

    714f. All IQCP studies shall be composed of no less than 20 consecutive different test samples.

    730g. All IQCP evaluations, reevaluations, assessments, actions or other such IQCP studies shall be documented and available for review by the Agency.

    7522. After an acceptable IQCP evaluation has been completed in accordance with these rules, the laboratory is permitted to institute IQCP in lieu of external quality control requirements of 78142 CFR 493.1256(d). 784However, if any of the following conditions occur, the laboratory shall cease testing or reinstitute the external quality control provisions of 80542 CFR 493.1256(d)808:

    809a. A proficiency testing score of less than 80% is obtained for any of the last three proficiency testing events;

    829b. Personnel competency problems are identified;

    835c. Major preventive maintenance or replacement of critical parts occurs;

    845d. Any IQCP result that was outside acceptable limits as specified in 85742 CFR 493.1256(d); 860or

    861e. When there is any indicator that inaccurate, imprecise or unreliable patient testing is being reported.

    8773. Before IQCP can be resumed, the laboratory must repeat the IQCP evaluation in accordance with the requirements of this rule and adjust the IQCP as the data warrants. External quality control procedures in accordance with 91342 CFR 493.1256(d) 916shall be performed until the subsequent IQCP evaluation meets the requirements of this rule.

    9304. When an IQCP failure occurs, the laboratory must conduct an investigation to identify the cause of the failure and examine all patient test results reported during the time that the IQCP evaluation was used to determine if there was any clinical impact on the patients tested during that time. Appropriate action shall be taken and documented if such patient impact is found.

    993Rulemaking Authority 995483.051 FS. 997Law Implemented 999483.051 FS. 1001History–New 11-20-94, Amended 6-22-06, 2-27-17.