1. A. Due to the life-threatening nature and effect of errors in newborn screening testing, the Secretary may order summarily the suspension of a permit if the Secretary finds that the public health, safety, or welfare imperatively requires emergency action, including but not limited to, if a permittee has:

   1. (1) Failed to report a newborn infant's abnormal test result as required in this chapter;

   2. (2) Falsified a document submitted to the Department, including but not limited to a:

      1. (a) Newborn infant screening test report; or
      2. (b) Quality control or quality assurance report; or
   3. (3) Failed to provide a corrected or amended test report if the permittee has reported an erroneous or questionable test result.

2. B. If the Secretary summarily suspends a permit as provided in §A of this regulation, the Secretary shall promptly give the permittee:

   1. (1) Written notice of the suspension, the finding, and the reasons that support the finding; and
   2. (2) An opportunity to be heard.

3. C. The Secretary may impose a directed plan of correction, limit testing, deny a permit renewal, or suspend or revoke a current permit if a permittee has:

   1. (1) Failed to meet the applicable standards and requirements set forth in:

      1. (a) Health-General Article, Title 17, Annotated Code of Maryland; or
      2. (b) COMAR 10.10.01—.08 and this chapter;
   2. (2) Conducted research on newborn infant blood-spot specimens within the Newborn Screening Program’s approval as required in Regulation .15 of this chapter; or
   3. (3) Failed to pay the Department any fee required under this subtitle.

4. D. In addition to sanctions provided in §§A and C of this regulation, the Secretary may:

   1. (1) Impose any sanction provided in COMAR 10.10.08; and
   2. (2) Refer a person for criminal prosecution, as provided at Health-General Article, §17-216, Annotated Code of Maryland.
5. E. A person may have a hearing on the imposition of a sanction and an opportunity to respond to a sanction imposed by the Secretary under this regulation as set forth in COMAR 10.10.08.03.
6. F. Except as provided in §§A and B of this regulation, before the Secretary denies, suspends, or revokes a permit, the Secretary shall give the applicant or permittee notice of the action and an opportunity to be heard.

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)