Sec. 10.10.06.06. Quality Control — Single-Use Test Devices

A. Primary Standard. This regulation applies to test systems that use single-use test devices as defined in COMAR 10.10.01.03B.

B. Standards.

(1) General. A licensee shall ensure that the test system is validated on a continuing basis and that the ongoing validation includes:

(a) Calibration verification;

(b) Parallel testing before or, when appropriate, instead of proficiency testing; and

(c) Proficiency testing.

(2) Requirements of the Test System's Manufacturer. In addition to the standards set forth in this regulation, a licensee shall ensure that the laboratory meets the quality control and quality assurance requirements of the test system's manufacturer.

(3) Test System Validation.

(a) Initial. Before implementing patient testing, a licensee shall ensure that the test system is validated to assure consistency with the test system manufacturer's performance attributes for acceptable accuracy, precision, and functions that affect test reliability and the competency of the testing personnel by:

(i) Performing and documenting at least 20 quality control tests for a period of at least 5 days of test system use in the environment and under the conditions that the test system will be used; and

(ii) Having all testing personnel participate in the validation process.

(b) Prior Testing. A test system placed in service for patient testing before the effective date of this chapter does not require an initial validation if a licensee ensures that the laboratory has:

(i) Maintained documented evidence of an established, comprehensive, and active quality assurance program; and

(ii) Participated satisfactorily in and continues to participate satisfactorily in an approved proficiency testing program or, when appropriate, periodically has conducted documented, parallel testing with split samples and periodically continues to conduct documented parallel testing with split samples.

(4) Validity Check. A licensee shall ensure that each time a test is performed the result of the validity check and any corrective action are documented when the result:

(a) Shows a single-use test device or test system failure;

(b) Indicates any substandard performance; or

(c) Requires operator intervention.

(5) System Check.

(a) Quantitative Test System. A licensee shall ensure that a system check for a quantitative test system is performed and documented:

(i) As specified by the manufacturer or at least once each 8 hours of test system use; and

(ii) After a single-use test device is exposed to an environment or condition that could affect the accuracy or reliability of test results.

(b) Qualitative Test System. A licensee shall ensure that a system check for a qualitative test system, if available, is performed and documented:

(i) As required by the manufacturer; or

(ii) Each day the test system is used.

(6) Quality Control Tests.

(a) Quantitative Test Systems. A licensee shall ensure that quality control testing for a quantitative test system is performed and documented using at least two levels of control material before patient testing:

(i) On each lot of a single-use test device received in a shipment;

(ii) At least weekly for each lot of a single-use test device used for patient testing;

(iii) After the test system undergoes maintenance, repair, adjustment, or an environmental exposure that could affect the accuracy and reliability of test results; and

(iv) Each day of use during the test system's validation.

(b) Qualitative Test System. A licensee shall ensure that quality control testing for a qualitative test system is performed and documented using known positive and negative control materials before patient testing:

(i) On each lot of a single-use test device received in a shipment;

(ii) At least weekly for each lot of a single-use test device used for patient testing;

(iii) After a single-use test device is exposed to an environment or condition that could affect the accuracy or reliability of test results; and

(iv) Each day of use during test system validation.

(7) Calibration and Verifying Calibration.

(a) Calibration. A licensee shall ensure that the test system is calibrated as directed by the manufacturer.

(b) Verifying Calibration. A licensee shall ensure that calibration of the test system is verified as directed by the manufacturer or at least every 6 months.

(8) Quality Assurance.

(a) Activities and Documentation. In addition to following other appropriate quality assurance standards in this chapter, a licensee shall ensure that quality assurance activities and documentation include reviewing, monitoring, and evaluating:

(i) Single-use test device lot number, expiration, and disposal; and

(ii) Testing discrepancies, including failed or repeat quality control or patient tests, validity checks, and system checks.

(b) Comparison of Test Results. When a facility performs a test using more than one method or test system, has multiple testing sites, or has multiple licensees performing the same test within a facility, the facility's primary or central testing site shall establish and maintain a quality assurance system that twice a year evaluates and defines the relationship of test results using the different methods, test systems, or testing sites.