1. A. Quality Control Program.

   1. (1) A permittee shall develop, establish, implement, maintain and follow written quality control policies, procedures, and techniques that provide and ensure accurate, reliable, and valid test results and reports.

   2. (2) A permittee's quality control program shall:

      1. (a) Cover all tests, methods, and procedures performed by the laboratory; and
      2. (b) Meet the standards and requirements set forth in this chapter and COMAR 10.10.06.

   3. (3) A permittee's quality control procedures and practices shall include, but are not limited to, the use of:

      1. (a) Analyses of reference materials to ensure the reproducibility and accuracy of test results;
      2. (b) Systems to ensure proper functioning of instruments, equipment, reagents, and performance of laboratory personnel;
      3. (c) Valid reagents, equipment, calibration, and systematic procedural checks;
      4. (d) A system that ensures timely and pertinent error detection and correction for the review and reporting of test results; and
      5. (e) Quality control materials from the Centers for Disease Control and Prevention's Newborn Screening Quality Assurance Program.

2. B. Adequacy of Methods and Equipment. To ensure the adequacy of test methods, test systems, and equipment, a permittee shall:

   1. (1) Employ methods, test systems, and equipment that provide accurate and reliable test results and reports;
   2. (2) Have sufficient and suitable equipment and instruments to perform the type and volume of tests offered and performed by the laboratory;
   3. (3) Perform tests in a manner that provides accurate and reliable test results;

   4. (4) Monitor test methods, instruments, and testing systems, where applicable, for the following performance characteristics:

      1. (a) Method, instrument, and test system detection limits and cutoff levels;
      2. (b) Precision;
      3. (c) Accuracy;
      4. (d) Specificity;
      5. (e) Sensitivity;
      6. (f) Interferences; and
      7. (g) Other related test variables that affect test results; and

   5. (5) Have adequate quality control systems and procedures in place to:

      1. (a) Obtain and verify a statistically valid number of counts or measurement levels to give accurate and reliable test results for an analytical instrument, each day an instrument is used for testing; and

      2. (b) Report results:

         1. (i) As set forth in COMAR 10.10.06.04;
         2. (ii) As set forth in 42 CFR §493.1291; and
         3. (iii) Within the time frames required by this chapter.

3. C. Supplies, Reagents, and Materials.

   1. (1) A permittee shall ensure that supplies, reagents, and other materials used in the collected, handling, testing, and storing of newborn blood-spot specimens are stored, labeled, checked for proper reactivity, and used according to the provisions of this chapter.

   2. (2) A permittee shall:

      1. (a) Label laboratory supplies and materials used in the testing process, including reagents, solutions, controls, and calibrators to indicate the:

         1. (i) Identity of reagents, solutions, controls, and calibrators;
         2. (ii) Strength or concentration;
         3. (iii) Storage requirements;
         4. (iv) Preparation and expiration date;
         5. (v) Identity of the preparer; and
         6. (vi) Other pertinent information that affects test performance;
      2. (b) Store laboratory materials in the manner recommended by the manufacturer;
      3. (c) Test representative samples of each lot of materials used for or in the process of testing blood-spot specimens on a regularly scheduled basis to determine that each lot of test material is capable of performing as required; and
      4. (d) Use supplies, reagents, kits, test systems, and other materials in a manner consistent with the recommendations and instructions provided by the manufacturer.

   3. (3) A permittee may not use supplies, reagents, kits, test systems, or other materials in the testing process that have:

      1. (a) Exceeded the materials' established expiration dates;
      2. (b) Substandard reactivity; or
      3. (c) Deteriorated.

Authority: Health-General Article, §§13-101—13-103, 13-108—13-112, 13-601—13-605, 17-201—17-206, 17-210,
17-211, 17-215, and 17-216, Annotated Code of Maryland

Effective date:

Regulations .01— .27 adopted as an emergency provision effective January 1, 2009 (36:2 Md. R. 97); adopted permanently effective March 23, 2009 (36:6 Md. R. 490)

Regulation .02A amended effective April 24, 2017 (44:8 Md. R. 404)

Regulation .03B amended effective April 24, 2017 (44:8 Md. R. 404)

Regulation .04B amended effective April 24, 2017 (44:8 Md. R. 404)

Regulation .06B amended as an emergency provision effective July 1, 2012 (39:15 Md. R. 962); amended permanently effective August 20, 2012 (39:16 Md. R. 1080)

Regulation .06B amended effective April 27, 2015 (42:8 Md. R. 608); April 14, 2025 (52:7 Md. R. 321)

Regulation .12 amended effective April 24, 2017 (44:8 Md. R. 404)

Regulation .12C amended effective August 23, 2021 (48:17 Md. R. 669); April 14, 2025 (52:7 Md. R. 321); May 25, 2026 (53:10 Md. R. 454)

Regulation .13 amended effective April 24, 2017 (44:8 Md. R. 404)

Regulation .14 amended effective April 24, 2017 (44:8 Md. R. 404)

Regulation .15 amended effective April 24, 2017 (44:8 Md. R. 404)

Regulation .16 amended effective April 24, 2017 (44:8 Md. R. 404)

Regulation .17 amended effective April 24, 2017 (44:8 Md. R. 404)

Regulation .18B amended effective April 24, 2017 (44:8 Md. R. 404)

Regulation .20A, C amended effective April 24, 2017 (44:8 Md. R. 404)

Regulation .21 amended effective April 24, 2017 (44:8 Md. R. 404)

Regulation .23 amended effective April 24, 2017 (44:8 Md. R. 404)

Regulation .24A, D amended effective April 24, 2017 (44:8 Md. R. 404)

Regulation .25 amended effective April 24, 2017 (44:8 Md. R. 404)

Regulation .26A amended effective April 24, 2017 (44:8 Md. R. 404)

Regulation .27C amended effective April 24, 2017 (44:8 Md. R. 404)