Code of Maryland Regulations
Title 10 - MARYLAND DEPARTMENT OF HEALTH
Part 3
Subtitle 10 - LABORATORIES
Chapter 10.10.13 - Medical Laboratories - Testing for Hereditary and Congenital Disorders in Newborn Infants
Section 10.10.13.27 - Sanctions

Universal Citation: MD Code Reg 10.10.13.27

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

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.

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