# COMAR Title 10 — Maryland Department of Health

## Subtitle 51 — Forensic Laboratories

### Chapter 03 — Licenses

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

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

**Administrative History:** Chapter, Licenses and Fees renamed Licenses effective August 29, 2016 (43:17 Md. R. 953)

**Administrative History:** Regulation .02A amended effective August 29, 2016 (43:17 Md. R. 953); March 13, 2017 (44:5 Md. R. 292)

**Administrative History:** Regulation .03 amended effective August 29, 2016 (43:17 Md. R. 953)

**Administrative History:** Regulation .03A, F amended effective March 13, 2017 (44:5 Md. R. 292)

**Administrative History:** Regulation .04 repealed effective August 29, 2016 (43:17 Md. R. 953)

#### Regulation .01 License — General.

*COMAR 10.51.03.01*

A. General Requirements.

  (1) A person shall obtain a license from the Secretary before performing or offering to perform a forensic analysis in this State.

  (2) A person may not perform or offer to perform forensic analysis without first obtaining a forensic laboratory license from the Secretary.

  (3) Letter of Permit Exception.

    (a) The Secretary may grant an individual a letter of permit exception if:

      (i) The individual is not affiliated with a public or commercial laboratory that performs forensic analyses;

      (ii) The application for the letter of permit exception is limited to an individual performing limited forensic analysis in a discipline or subdiscipline; and

      (iii) The individual applying for the letter of permit exception has documentation that demonstrates the individual’s competency and experience in the specific forensic discipline or subdiscipline in which the forensic analysis will be performed.

    (b) The individual who will perform the forensic analysis shall:

      (i) Submit an application for a letter of permit exception to the Department for approval;

      (ii) Renew a letter of permit exception every 3 years from the date of issuance, if renewal is desired;

      (iii) Be subject to oversight by the Department; and

      (iv) Be subject to the sanctions set forth in COMAR 10.51.07.

  (4) Waiver.

    (a) The Secretary may grant to a forensic laboratory not located in this State, a waiver from the licensing requirements of this subtitle if:

      (i) The forensic analysis or examination is not performed by a licensee;

      (ii) The waiver is limited to a single case or related cases; and

      (iii) The person requesting the waiver has documentation that demonstrates the forensic laboratory’s competency and quality.

    (b) A licensee, a party to a criminal case or related cases, or the forensic laboratory that has been requested to perform a forensic analysis shall:

      (i) Submit a request for a waiver for approval by the Department; and

      (ii) Make requests in accordance with the process established by the Department.

    (c) The Department may require an out-of-State laboratory that has been waived for licensure to apply for licensure based on the number of waivers issued to that laboratory by the Department.

    (d) The Department may deny a waiver if:

      (i) The Department determines the laboratory has been the subject of frequent waiver requests and the laboratory has failed to apply for licensure; or

      (ii) The laboratory’s license application was denied or its license was suspended or revoked by the Department.

  (5) Prohibited Analyses. The Secretary may impose principal and alternative sanctions as set forth in this subtitle if a person performs or offers to perform a forensic analysis or part of a forensic analysis, including the use of a reagent, supply, procedure, method, technique, kit, or equipment, that:

    (a) Does not produce accurate or reliable forensic analysis results as evidenced by documented, independent scientific testing and evaluation; or

    (b) Lacks proof of efficacy substantiated by independently conducted and documented scientifically based evidence.

B. Limitation. A person may not operate a forensic laboratory in a forensic science discipline or subdiscipline other than what is listed on the license unless it is a discipline or subdiscipline listed under COMAR 10.51.01.02C .

C. Application Eligibility. A person meeting the requirements and standards of this subtitle and the requirements set forth in Health-General Article, Title 17, Subtitle 2A, Annotated Code of Maryland, may apply for a forensic laboratory permit.

D. Issuance.

  (1) Permit. The Secretary may issue a permit that:

    (a) Is valid for not more than 3 years from the date of issue; and

    (b) Shall be renewed before the date of expiration if a person intends to operate the forensic laboratory in the succeeding permit period.

  (2) Site License Required. A person shall obtain a separate license for each location at which the person maintains a site to perform forensic analyses.

E. In order to maintain a State license issued by the Department pursuant to this subtitle, a licensee shall be in compliance with all applicable federal, State, and local requirements.

#### Regulation .02 License — Requirements.

*COMAR 10.51.03.02*

A. Requirements. A person operating a forensic laboratory that performs one or more forensic analyses shall:

  (1) Obtain, complete, and submit written or electronic permit applications as prescribed in this subtitle;

  (2) Obtain a forensic laboratory license as required in this subtitle; and

  (3) Renew a forensic laboratory license as required in this subtitle.

B. Regulatory Requirements. A person operating a forensic laboratory under a license shall comply with the:

  (1) Audit requirements set forth in COMAR 10.51.02.03;

  (2) Applicable proficiency testing requirements set forth in COMAR 10.51.04;

  (3) Applicable ethics, data integrity, and non-retaliation requirements set forth in COMAR 10.51.05.16 and .17;

  (4) Applicable quality systems, quality assurance, and quality control requirements set forth in COMAR 10.51.05;

  (5) Applicable employee requirements set forth in COMAR 10.51.06; and

  (6) Applicable federal, State, and local requirements regarding the operation of forensic laboratories.

#### Regulation .03 License — Administrative Procedures.

*COMAR 10.51.03.03*

A. Application — Filing.

  (1) A person shall:

    (a) Apply for a license for each forensic laboratory location;

    (b) File an application for a license using written or electronic forms provided by the Department; and

    (c) Include in the application a description of forensic laboratory services, which includes but is not limited to:

      (i) Types of forensic analyses performed or to be performed;

      (ii) Total number of individuals who perform forensic analyses for each forensic science discipline; and

      (iii) Qualifications of employees who direct, supervise, and perform forensic analyses.

  (2) The forensic laboratory director shall sign the application forms attesting that the:

    (a) Information provided in the application is accurate; and

    (b) Forensic laboratory is or will be operated in accordance with the requirements and standards set forth in this subtitle.

B. Application — Evaluation and Billing. The Department shall review and evaluate an application in accordance with the standards and requirements of this subtitle to determine if the:

  (1) Application is complete; and

  (2) Forensic laboratory is eligible for a license.

C. Application — Denial of License. If the Department determines that a forensic laboratory is not in compliance with the requirements of this subtitle and therefore cannot be issued a license, the Department shall provide to the forensic laboratory:

  (1) A written statement of the grounds on which the denial is based; and

  (2) The opportunity to:

    (a) Amend and resubmit the application; or

    (b) Request, in writing, an opportunity for a hearing as provided in the Administrative Procedure Act, State Government Article, §§10-201 — 10-226, and Health-General Article, §17-2A-09, Annotated Code of Maryland.

D. Notification Requirements. A licensee shall notify the Department within 30 days of a change in forensic laboratory:

  (1) Ownership;

  (2) Name;

  (3) Location; or

  (4) Director.

E. Amending a License. Except as prescribed in §D of this regulation, a licensee holding an unexpired license who wishes to have a permit amended shall:

  (1) Submit a written request to amend the license to the Department;

  (2) Remit to the Department a $50 relicensing fee; and

  (3) Obtain written approval from the Department before implementing the change to the forensic laboratory’s operation or forensic analysis that is affected by the amendment.

F. Expiration and Renewal.

  (1) A license expires on the date shown on the license.

  (2) The Department shall provide a renewal application to a forensic laboratory not less than 30 days before the expiration date shown on the license.

  (3) In order to renew a license, a licensee shall file an application to renew the license using written or electronic forms provided by the Department and following the same procedures prescribed in §§A and B of this regulation.

  (4) A licensee who fails to submit a completed renewal application before the expiration date may not operate the forensic laboratory after the permit expiration date.

G. Non-Transferability. A license is not transferable.

H. Addition of a New Discipline, Subdiscipline, or Forensic Analysis.

  (1) A licensee shall:

    (a) Apply for a provisional license for each new discipline, subdiscipline, or forensic analysis the licensee wishes to perform;

    (b) File an application for a provisional license using forms provided by the Department;

    (c) Include in the application a description of each new discipline, subdiscipline, or forensic analysis; and

    (d) Make payment of any fees associated with each new addition.

  (2) A licensee shall provide documentation of:

    (a) Validation for the new discipline, subdiscipline, or forensic analysis; and

    (b) Completion of training to include competency tests, and if applicable, proficiency tests of individuals who perform analyses within each new discipline, subdiscipline, or forensic analysis.

  (3) An accredited licensee shall be subject to review by the Department until the new discipline, subdiscipline, or forensic analysis is accredited.