Md. Code Regs. 10.51.07.01

Current through Register Vol. 51, No. 22, November 1, 2024

Section 10.51.07.01 - Sanctions - General

A. Authority and Types.

(1) The Secretary may impose one or more principal or alternative sanctions if a forensic laboratory or the laboratory's director or other employees fail to meet the standards of this subtitle and Health"General Article, Title 17, Subtitle 2A, Annotated Code of Maryland.

(2) Principal Sanctions. The Secretary may impose the following principal sanctions:

(a) Denial of a license;

(b) Suspension of a license; or

(c) Revocation of a license.

(3) Alternative Sanctions. Instead of or in conjunction with withdrawing a principal sanction, the Secretary may impose one or more of the following alternative sanctions:

(a) A directed plan of correction;

(b) Limitation on forensic analyses; or

(c) Training and technical assistance.

B. Reasons for Imposition. The Secretary may impose on a forensic laboratory one or more sanctions if the Secretary finds:

(1) A deficiency identified through:

(a) An on-site audit; or

(b) A review of materials submitted by a forensic laboratory that shows a problem with:

(i) Application data;

(ii) Employee qualification materials; or

(iii) Internal audits;

(2) Unsuccessful proficiency test performance;

(3) Demonstrated incompetence, such as showing consistent or repetitive errors in:

(a) Operating forensic laboratory equipment; or

(b) Performing a forensic analysis;

(4) False statements made on an application, allegation of compliance, or other form submitted to the Department;

(5) Misrepresentation in obtaining a license or in operating a forensic laboratory;

(6) Submission of a sample or specimen by a forensic laboratory inside the State to another laboratory that does not possess a license or a waiver as set forth in this subtitle; or

(7) A violation of a law of the State pertaining to a forensic laboratory.

C. Factors Affecting Choice of Sanctions. The Secretary shall choose which sanctions to apply to a forensic laboratory based on, but not limited to, the following:

(1) Whether a deficiency poses immediate jeopardy to public safety or individual rights;

(2) The nature, incidence, severity, and duration of the deficiency;

(3) Whether a deficiency has been identified repeatedly;

(4) Whether the Department can determine the laboratory's compliance due to inaccurate record keeping or the licensee's lack of documentation or laboratory records, including those required for quality assurance and quality control;

(5) Failure to make records available to the Department;

(6) The relationship of one deficiency or group of deficiencies to another deficiency;

(7) The overall compliance history of a forensic laboratory, including but not limited to any period of noncompliance that occurred between the Secretary's determinations of compliance;

(8) The corrective and long-term compliance outcomes the Secretary intends to effect through application of the sanction; and

(9) The progress a forensic laboratory has made toward regulatory compliance following a reasonable opportunity to correct a deficiency.

D. Improper Referral of Proficiency Testing Samples. If the Department determines that a forensic laboratory has intentionally referred a proficiency testing sample to another laboratory for analysis, the Secretary:

(1) Shall revoke the forensic laboratory's license for a period of 1 year; and

(2) May also impose one or more alternative sanctions.

E. Owning and Operating Prohibition Following Revocation. A person who has owned, operated, or directed a forensic laboratory that has had the laboratory's license revoked may not, within 1 year of the revocation, apply for a license for or own, operate, or direct a forensic laboratory.

Md. Code Regs. 10.51.07.01