# COMAR Title 10 — Maryland Department of Health

## Subtitle 51 — Forensic Laboratories

### Chapter 07 — Sanctions

**Authority:** Health-General Article, Title 17, Subtitle 2A, Annotated Code of Maryland

**Administrative History:** Effective date: May 28, 2012 (39:10 Md. R. 660)

#### Regulation .01 Sanctions — General.

*COMAR 10.51.07.01*

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.

#### Regulation .02 Sanctions — Departmental Actions.

*COMAR 10.51.07.02*

A. Deficiency Posing Immediate Jeopardy.

  (1) If a forensic laboratory’s deficiency poses immediate jeopardy to public safety or individual rights, the Secretary shall take one or more of the actions listed in §A(2) and (3) of this regulation.

  (2) Initial Actions. When a deficiency involving immediate jeopardy is first identified, the Secretary shall:

    (a) Require the forensic laboratory to take immediate action to remove the jeopardy; and

    (b) Impose:

      (i) A principal sanction after giving the forensic laboratory at least 24 hours’ notice; or

      (ii) One or more alternative sanctions.

  (3) Follow-up Actions. If the Department finds, in a follow-up audit of a forensic laboratory under an alternative sanction, that the forensic laboratory has not eliminated the immediate jeopardy, the Secretary shall impose a principal sanction after giving the forensic laboratory at least 24 hours’ notice.

B. Deficiency Not Posing Immediate Jeopardy.

  (1) If a forensic laboratory’s deficiency does not pose immediate jeopardy to personal or public safety, the Secretary may take one or more of the actions listed in §B(2)—(4) of this regulation.

  (2) Initial Actions. When a deficiency is first identified, the Secretary may impose one or more alternative sanctions or a principal sanction.

  (3) Unsuccessful Proficiency Testing Participation. If a forensic laboratory exhibits unsuccessful proficiency testing, as set forth in this subtitle, the Secretary may impose the training and technical assistance requirements set forth in Regulation .04 of this chapter as a directed plan of correction, as well as any other sanction.

  (4) Follow-up Actions. If the Department finds in a follow-up audit, that a forensic laboratory has not initiated a corrective action for a deficiency within 30 days after the deficiency was identified, the Secretary may:

    (a) Impose, or continue if already imposed, one or more sanctions;

    (b) Conduct one or more on-site audits to evaluate progress in the correction of a deficiency; and

    (c) Conduct an additional follow-up on-site audit to determine whether all corrections have been made.

C. Duration of a Sanction. A sanction shall remain in force until:

  (1) A forensic laboratory corrects the deficiency; or

  (2) A forensic laboratory’s license is revoked.

D. Withdrawal of a Sanction.

  (1) General. The Secretary may not withdraw a sanction until the Secretary verifies regulatory compliance with this subtitle.

  (2) Credible Allegation of Compliance. When a sanctioned forensic laboratory submits a credible allegation of compliance, the Secretary may determine compliance through one or more of the following ways:

    (a) On the basis of the evidence submitted by the forensic laboratory in the allegation; or

    (b) A follow-up audit to verify whether the forensic laboratory has achieved compliance.

  (3) If a forensic laboratory does not correct all deficiencies within 30 days after imposition of a sanction, the Secretary may initiate action to suspend or revoke the license.

#### Regulation .03 Principal Sanctions — Departmental Actions.

*COMAR 10.51.07.03*

A. Hearing Requirement.

  (1) Except when the Secretary finds that a danger to public safety imperatively requires that emergency action be taken to correct a deficiency, the Secretary shall inform the licensee in writing:

    (a) If a suspension or revocation of the licensee’s license takes effect;

    (b) The reason for the suspension or revocation; and

    (c) 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) If the Secretary finds a condition that imperatively requires emergency or immediate action to preserve public safety or individual rights, the Secretary shall inform the licensee in writing:

    (a) When a suspension or revocation of the licensee’s license takes effect;

    (b) The reason for the suspension or revocation; and

    (c) That the licensee has an opportunity for a hearing on the matter, as provided in State Government Article, §10-226, 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 forensic laboratory to respond to the notice.

  (2) Opportunity to Respond. During the time allowed and stated in the written notice, a forensic 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 that imperatively requires emergency or immediate action, the Secretary shall provide notice at least 24 hours before the effective date of the sanction, unless conditions warrant immediate suspension.

    (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.

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

#### Regulation .04 Enforcement Procedures — Proficiency Testing.

*COMAR 10.51.07.04*

A. Application. If a forensic laboratory’s performance in proficiency testing is unsatisfactory, as set forth in this subtitle, the Secretary may require the forensic laboratory to undertake the directed plan of correction of training the forensic laboratory employees or obtaining technical assistance, or both, in order to meet the proficiency testing requirements of this subtitle.

B. Procedures. A forensic laboratory required to undertake training of employees or to obtain necessary technical assistance shall:

  (1) Document the training or assistance, or both, using a form provided by the Department; and

  (2) Submit the completed form to the Department.

#### Regulation .05 Departmental Action — Reporting Erroneous Test Results.

*COMAR 10.51.07.05*

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.