Md. Code Regs. 10.10.08.01

Current through Register Vol. 51, No. 25, December 13, 2024

Section 10.10.08.01 - General

A. Authority and Types.

(1) The Secretary may impose one or more principal or alternative sanctions.

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

(a) Denial of a license;

(b) Suspension of a license; and

(c) Revocation of a license.

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

(a) A directed plan of correction;

(b) Limitation on testing; and

(c) Training and technical assistance.

B. Reasons for Imposition. A laboratory is subject to the imposition of one or more sanctions when the OHCQ finds:

(1) A deficiency identified through an on-site survey or a review of materials submitted by a laboratory, such as applications data, personnel qualification materials, and self-inspection checklists;

(2) Unsuccessful proficiency testing performance;

(3) Demonstrated incompetence, such as showing consistent or repetitive errors in operating equipment or in performing a test or procedure;

(4) False statements made on an application, plan-of-correction, or other form submitted to the OHCQ;

(5) Misrepresentation in obtaining a permit or letter of exception or in operating a laboratory;

(6) Failure to comply with the:

(a) Cancer reporting requirements of Health-General Article, §18-204, Annotated Code of Maryland; and

(b) Infectious disease and submission of clinical material requirements of Health-General Article, §18-205, Annotated Code of Maryland, and COMAR 10.06.01;

(7) Submission of a specimen by a laboratory inside the State to another laboratory that does not possess a license as set forth in COMAR 10.10.03;

(8) Conviction by a court of a violation of the laws of the State pertaining to a medical laboratory; or

(9) Exceeding the 50 test per year limit when operating under a letter of exception-limited testing for rare diseases as set forth in COMAR 10.10.03.05B.

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

(1) Whether a deficiency poses immediate jeopardy to personal or public health or safety;

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

(3) Whether a deficiency has been identified repeatedly;

(4) The inaccuracy or extent of missing laboratory records, such as missing documentation of remedial action or failure to make records available to the OHCQ;

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

(6) The overall compliance history of a laboratory, including but not limited to any period of noncompliance that occurred between determinations of compliance;

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

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

D. Mandatory Revocation of a License. The Secretary shall revoke for 1 year the license of a laboratory that intentionally refers a proficiency test sample to another laboratory for analysis.

E. Owning and Operating Prohibition Following Revocation. A person who has owned, operated, or directed a laboratory that has had its license revoked may not, within 1 year of the revocation, apply for a license, or own or operate a laboratory for which a license has been issued under this chapter.

Md. Code Regs. 10.10.08.01

Regulation .01B amended effective June 1, 2009 (36:11 Md. R. 787)