Code of Maryland Regulations
Title 10 - MARYLAND DEPARTMENT OF HEALTH
Part 3
Subtitle 10 - LABORATORIES
Chapter 10.10.08 - Medical Laboratories-Sanctions
Section 10.10.08.03 - Departmental Actions - Principal Sanctions

Universal Citation: MD Code Reg 10.10.08.03

Current through Register Vol. 51, No. 19, September 20, 2024

A. Hearing Requirement.

(1) Except when the Secretary finds that a danger to public health or safety imperatively requires that emergency action be taken to correct a deficiency, the Secretary shall inform the licensee in writing when a suspension or revocation of the licensee's license takes effect, the reason for the suspension or revocation, and that the licensee has an opportunity for a hearing on the matter before the suspension or revocation takes effect, as provided in State Government Article, §10-226, Annotated Code of Maryland.

(2) When a finding is made that the public health or safety imperatively requires that emergency or immediate action be taken, the Secretary shall inform the licensee in writing of a suspension or revocation of the licensee's license, the reason for the suspension or revocation, and that the licensee has an opportunity for a hearing on the matter, as provided in State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland, after the suspension or revocation.

B. Notice.

(1) Contents. In cases involving a principal sanction, the Secretary shall give written notice to a licensee of the:
(a) Deficiency identified;

(b) Sanction proposed for imposition;

(c) Reason for the proposed sanction;

(d) Projected effective date and duration of the proposed sanction;

(e) Authority for the proposed sanction; and

(f) Time allowed for a laboratory to respond to the notice.

(2) Opportunity to Respond. During the time allowed and stated in the written notice, a laboratory may submit to the Secretary written evidence or other information against imposition of the proposed sanction or sanctions.

(3) Notice Times.
(a) If a deficiency is found imperatively to require emergency or immediate action, the Secretary shall provide notice at least 24 hours before the effective date of sanction.

(b) If a deficiency is found to warrant a principal sanction but does not imperatively require emergency or immediate action, the Secretary shall provide notice at least 10 days before the effective date of sanction.

(c) To preserve its right to a hearing, a licensee shall request a hearing within 10 days of its receipt of the notice of the pending sanction.

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