Md. Code Regs. 10.10.13.27

Current through Register Vol. 51, No. 26, December 27, 2024

Section 10.10.13.27 - Sanctions

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

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

(a) Newborn infant screening test report; or

(b) Quality control or quality assurance report; or

(3) Failed to provide a corrected or amended test report if the permittee has reported an erroneous or questionable test result.

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

(1) Written notice of the suspension, the finding, and the reasons that support the finding; and

(2) An opportunity to be heard.

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

(a) Health-General Article, Title 17, Annotated Code of Maryland; or

(b) COMAR 10.10.01-.08 and this chapter;

(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) Failed to pay the Department any fee required under this subtitle.

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

(1) Impose any sanction provided in COMAR 10.10.08; and

(2) Refer a person for criminal prosecution, as provided at Health-General Article, §17-216, Annotated Code of Maryland.

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 10.10.08.03B.

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.

Md. Code Regs. 10.10.13.27

Regulations .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); amended effective 44:8 Md. R. 404, eff. 4/24/2017