.05 Departmental Action — Reporting Erroneous Test Results.

A. If the Department determines that a licensee has reported an erroneous test result that threatens the safety or rights of an individual, the Secretary may order the licensee, within a specified period of time, to:

(1) Give prompt notice of the erroneous test result to:

(a) The person who ordered the forensic analysis be performed;

(b) Any other person to whom the forensic laboratory has previously sent a report that contained the erroneous test result;

(c) The Office of Public Defender or counsel of record; and

(d) The State’s Attorney;

(2) Provide corrected reports to the persons notified in §A(1) of this regulation;

(3) Maintain a duplicate copy of both the original report and the corrected report;

(4) Conduct a quality assessment of all phases of the testing or examination process to determine the cause of the erroneous forensic analysis test result;

(5) Take the necessary remedial or corrective action to prevent recurrence of the problem; and

(6) Take any additional measures necessary to reduce or eliminate the threat to public safety or individual rights.

B. Civil Money Penalty for Failure to Comply with Order.

(1) A forensic laboratory that fails to comply with an order issued by the Secretary under §A of this regulation is subject to a civil money penalty of up to $1,000 for each day of noncompliance, up to a maximum of $50,000.

(2) The Secretary may impose the civil money penalty instead of, or in addition to, any other sanction imposed under this chapter.

C. Notice and Hearing.

(1) Notice. Before the Secretary imposes a civil money penalty for noncompliance as provided in §B of this regulation, the Secretary shall give written notice to a licensee:

(a) Of the intent to impose a civil money penalty; and

(b) That the licensee has an opportunity for a hearing on the matter before the civil money penalty is imposed.

(2) Content. The Secretary shall give written notice to the licensee of the:

(a) Reason for the imposition of the civil money penalty;

(b) Amount of the civil money penalty;

(c) Effective date of the imposition of the civil money penalty;

(d) Time allowed for the licensee to respond to the notice; and

(e) Authority for imposing the civil money penalty.

(3) Opportunity to Respond. During the time allowed and stated in the written notice from the Secretary, the licensee may submit to the Secretary written evidence or other information to support the position that the licensee has not violated the requirements of this subtitle or Health-General Article, Title 17, Subtitle 2A, Annotated Code of Maryland.

(4) To preserve the right to a hearing, the licensee shall request a hearing within 10 days of receipt of the notice of the Secretary’s intent to impose the civil money penalty.

D. Factors to Be Considered in the Assessment of Penalties. In cases in which the Secretary determines that the imposition of a civil money penalty is appropriate, the Secretary shall consider the following factors in determining the amount of the penalty:

(1) The extent to which the licensee derived any financial or other benefit from reporting erroneous forensic analysis results;

(2) The willfulness on the part of the licensee to violate this subtitle or Health-General Article, Title 17, Subtitle 2A, Annotated Code of Maryland;

(3) The extent of actual or potential harm caused by the reporting of erroneous forensic analysis results;

(4) The cost of investigating and prosecuting the case against the licensee;

(5) The licensee’s history of previous failure to meet the standards of this subtitle; and

(6) The existence of mitigating factors.