1. A. A permittee shall:

   1. (1) Establish and follow a written quality assessment plan that covers all phases of the testing process;
   2. (2) Meet the applicable quality assurance requirements of COMAR 10.10.06; and

   3. (3) Have an accessioning mechanism or system that:

      1. (a) Tracks blood-spot specimens and allows first and subsequent blood-spot specimens and test results from the same newborn infant to be linked for testing and analysis; and
      2. (b) Identifies a specific analyte that requires retesting when a newborn infant's prior screening test results for that analyte are abnormal or border-line abnormal.

2. B. A permittee may not test a blood-spot specimen exhibiting:

   1. (1) Blood that did not saturate the filter paper;
   2. (2) A circle containing no blood;
   3. (3) A blood clot or tissue on the surface of the blood;
   4. (4) A circle over-saturated with blood showing dark areas in the circle or at the perimeter;
   5. (5) Blood that appears layered or clotted; or
   6. (6) Serum rings or blood that appears diluted, discolored, or contaminated.

3. C. A permittee may not test a blood-spot specimen:

   1. (1) Collected more than 10 days before the screening test is to be started;

   2. (2) That is unaccompanied by information necessary for the testing to be meaningful, including the:

      1. (a) Age of the newborn infant;
      2. (b) Identification of the newborn infant;
      3. (c) Date and time of blood-spot specimen collection;
      4. (d) Date and time of birth;
      5. (e) Newborn infant's weight; and
      6. (f) Date and time of a newborn infant's first feeding;
   3. (3) If an infant was transfused before the first screening and the repeat blood-spot specimen collected to test for hemoglobin was drawn earlier than 4 months after the last transfusion; or

   4. (4) If the newborn infant was younger than 24 hours old or the newborn's age was unknown at the time of collection and the requested screening test is for:

      1. (a) Congenital adrenal hyperplasia as specified in Regulation .12C(2) of this chapter; or
      2. (b) Thyroxine or thyroid stimulating hormone as specified in Regulation .12C(4) of this chapter.

4. D. Within 24 hours of receipt of an unsatisfactory blood-spot specimen, the permittee shall notify the submitter of the unsatisfactory blood-spot specimen by telephone, facsimile, or electronic mail:

   1. (1) That the blood-spot specimen cannot be tested; and
   2. (2) To submit another blood-spot specimen as soon as possible.

5. E. If a permittee reports a test result on a newborn infant and later discovers that the test result was erroneous or questionable, the permittee shall:

   1. (1) Give prompt notice of the erroneous or questionable patient test result to the:

      1. (a) Person who requested that the test be performed;
      2. (b) Physician or other person to whom the laboratory has previously sent a report that contained the erroneous or questionable result; and
      3. (c) Follow-Up Unit;
   2. (2) Provide corrected reports to the persons notified in §E of this regulation;
   3. (3) Maintain duplicates of both the original report and the corrected report;
   4. (4) Conduct a quality assessment of all phases of the testing process to determine the cause of the erroneous or questionable test result;
   5. (5) Take the necessary remedial or corrective action to prevent recurrence of the problem; and

   6. (6) Take any additional measures necessary to reduce or eliminate the threat to the health and safety of the patient including:

      1. (a) Notifying a parent or guardian of the newborn infant of the erroneous or questionable result;
      2. (b) Retesting the same blood-spot specimen;
      3. (c) Testing a new blood-spot specimen; and
      4. (d) Retesting the same blood-spot specimen and testing a new blood-spot specimen.

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)