# COMAR Title 10 — Maryland Department of Health

## Subtitle 51 — Forensic Laboratories

### Chapter 02 — Responsibilities, Accreditations, and Audits

**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:** Regulation .01D amended effective August 29, 2016 (43:17 Md. R. 953)

#### Regulation .01 Responsibilities of the Department.

*COMAR 10.51.02.01*

A. The Department shall conduct audits, as set forth in this chapter, of forensic laboratories that obtain or retain a license.

B. Audits. The Department shall:

  (1) Conduct or oversee an announced or unannounced audit of a forensic laboratory, at any time during a forensic laboratory’s hours of operation, to assess compliance with applicable sections of Health-General Article, Title 17, Subtitle 2A, Annotated Code of Maryland, and this subtitle; and

  (2) Examine, as part of an audit, a forensic laboratory’s facilities, equipment, quality assurance records and procedures, operating procedures, employees, employee records, proficiency testing, results and reports of forensic analyses, and other records and files pertinent and subject to this subtitle.

C. Issuance of Licensing Documents. The Department shall:

  (1) License a person to operate a forensic laboratory by issuing a license when the forensic laboratory is in compliance with the applicable standards set forth in this subtitle; and

  (2) Issue a license that includes the:

    (a) Name of the forensic laboratory;

    (b) Name of the licensee or owner;

    (c) Name of the forensic laboratory director;

    (d) Expiration date of the license; and

    (e) Forensic science disciplines and subdisciplines in which the forensic laboratory is authorized to perform forensic analyses.

D. Administration and Information Management. The Department shall:

  (1) Maintain a list of licensed forensic laboratories;

  (2) Document information regarding denial, suspension, or revocation of a license and submit this documentation to the Secretary;

  (3) Monitor the proficiency testing performance of a forensic laboratory required to participate in proficiency testing;

  (4) Impose alternative sanctions and initiate actions leading to imposition of principal sanctions against a forensic laboratory under the appropriate provisions of this subtitle and Health-General Article, Title 17, Subtitle 2A, Annotated Code of Maryland.

E. Forensic Laboratory Advisory Committee.

  (1) The Secretary shall provide staff for the Forensic Laboratory Advisory Committee established by the Governor pursuant to Health-General Article, Title 17, Subtitle 2A, Annotated Code of Maryland.

  (2) The Forensic Laboratory Advisory Committee:

    (a) Shall advise the Secretary on matters relating to forensic laboratories as set forth in Health-General Article, Title 17, Subtitle 2A, Annotated Code of Maryland; and

    (b) May make recommendations to the Secretary concerning the:

      (i) Implementation of the requirements for forensic laboratories set forth in Health-General Article, Title 17, Subtitle 2A, Annotated Code of Maryland;

      (ii) Regulations required by Health-General Article, Title 17, Subtitle 2A, Annotated Code of Maryland; and

      (iii) Department’s oversight and licensing of forensic laboratories.

#### Regulation .02 Accredited Forensic Laboratory and Accrediting Organization.

*COMAR 10.51.02.02*

A. Accredited Forensic Laboratory — Determination. The Secretary shall accept as meeting the audit requirements of this subtitle a forensic laboratory accredited by an organization approved by the Secretary, as set forth in §C of this regulation, if the Department determines that the standards of the forensic laboratory’s accreditation organization are equivalent to those under this subtitle.

B. Accredited Forensic Laboratory — Requirements. In addition to meeting the requirements for obtaining and maintaining a certificate of accreditation, as set forth by the forensic laboratory’s accrediting organization, an accredited forensic laboratory shall:

  (1) Obtain and maintain a valid license issued by the Department; and

  (2) Be subject to audit by the Department as set forth in COMAR 10.51.02.03.

C. Accreditation Organization.

  (1) A private, nonprofit forensic laboratory accreditation organization may inspect and accredit forensic laboratories in the State for the purpose of State licensure only after applying for and receiving approval of the Department, as the Secretary’s designee.

  (2) The Department shall base approval of a forensic laboratory accreditation organization on a review of information provided by that organization, including but not limited to:

    (a) Data collection and data sharing and reporting policies;

    (b) Accreditation policies, procedures, and standards;

    (c) Assessment forms and guidelines;

    (d) Assessment and deficiency writing policies and procedures;

    (e) Assessor and technical expert qualifications;

    (f) Complaint investigation policies and procedures;

    (g) Proficiency test monitoring policies and procedures; and

    (h) Procedures the accreditation organization will follow when notifying the Department that the accreditation organization:

      (i) Is denying, withdrawing, suspending, revoking, or otherwise limiting a forensic laboratory’s accreditation;

      (ii) Finds serious jeopardy to individual rights or identifies a hazard to public safety;

      (iii) Accredits a new forensic laboratory;

      (iv) Imposes an adverse or corrective action on a forensic laboratory; or

      (v) Is initiating a complaint investigation.

  (3) In addition to requirements set forth elsewhere in this subtitle, an accreditation organization shall:

    (a) Provide to the Department:

      (i) Annually, an updated list containing the names, addresses, and accreditation expiration dates of forensic laboratories in the State that are accredited by the organization;

      (ii) Within 30 days after conducting an assessment, a certified written or electronic copy of each assessment report covering each forensic laboratory applying for or maintaining accreditation in the State;

      (iii) Written notice of any proposed change to requirements for forensic laboratory accreditation, at least 30 days before the effective date of the change;

      (iv) Within 10 days after a forensic laboratory’s certificate of accreditation expires, written or electronic notice when the forensic laboratory does not renew an accreditation certificate; and

      (v) Within 24 hours after taking an action, telephonic or electronic notice when an accredited forensic laboratory’s certificate of accreditation is suspended, revoked, surrendered, or otherwise limited;

    (b) Evaluate compliance, when applicable, with State regulations pertaining to:

      (i) Forensic analyses;

      (ii) Reporting of forensic analysis results as required by law or regulation; and

      (iii) Proficiency testing;

    (c) Evaluate compliance with State regulations by:

      (i) Incorporating an evaluation of compliance with State regulatory requirements into the accreditation organization’s own assessment process; or

      (ii) Demonstrating that the accreditation organization’s existing assessment process adequately evaluates compliance with State regulations; and

    (d) On request, provide to the Department a copy of:

      (i) A complaint investigation;

      (ii) Assessor qualifications;

      (iii) A change in a forensic laboratory’s forensic disciplines or subdisciplines; or

      (iv) Other information the Department may require relating to approval of a forensic laboratory accreditation organization.

#### Regulation .03 Audits.

*COMAR 10.51.02.03*

A. General.

  (1) A licensee shall allow an on-site audit by the Department and, when applicable, by the forensic laboratory’s accreditation organization, at any time during the forensic laboratory’s normal hours of operation, to evaluate the forensic laboratory’s compliance with the applicable requirements, conditions, and standards of this subtitle.

  (2) An audit may include but is not limited to observation and examination of:

    (a) Laboratory facilities;

    (b) Equipment;

    (c) Quality assurance and quality control program records;

    (d) Operating procedures;

    (e) Employees;

    (f) Employee records;

    (g) Proficiency testing;

    (h) Forensic analysis reports; and

    (i) Other records and files pertinent to this subtitle.

  (3) Forensic laboratory employees shall make data and records accessible during an on-site audit.

B. Permitted Forensic Laboratory. A licensee operating a forensic laboratory under a permit shall:

  (1) Be subject to routine audits conducted by the Department;

  (2) Undergo a routine audit within 6 months after the forensic laboratory:

    (a) Begins operating;

    (b) Undergoes a change in ownership; or

    (c) Has had a principal or alternative sanction imposed; and

  (3) Undergo a routine triennial audit after meeting the audit requirements set forth in §B(2) of this regulation.

C. Accredited Forensic Laboratory. An accredited forensic laboratory is:

  (1) Not subject to routine audits conducted by the Department as set forth in §B of this regulation if the accredited forensic laboratory is undergoing routine on-site assessment conducted by an accreditation organization approved by the Secretary, except as provided in §C(2) of this regulation; and

  (2) Subject to audits conducted by the Department to:

    (a) Investigate a complaint;

    (b) Determine regulatory compliance with any quality requirement;

    (c) Follow up on any serious problem identified by an accreditation organization; or

    (d) Validate an accreditation organization’s assessment of a forensic laboratory.

D. Public Record.

  (1) A forensic laboratory shall make discrepancy logs, contamination records, test results, and final inspection reports, including deficiency statements and plans of correction, available to the public within 30 business days of a written request for these public documents.

  (2) Except as identified in this section or as otherwise provided by law, the proceedings, records, and files of an organization or State agency responsible for assuring compliance with this subtitle shall be confidential and may not be discoverable or admissible as evidence in a civil or criminal action.

E. Internal Audits.

  (1) A forensic laboratory shall conduct and document an annual audit of the overall operations of the forensic laboratory and generate a written audit report that identifies the finding and the corrective action taken to address the noncompliance.

  (2) The forensic laboratory shall:

    (a) Report the audit documentation to the Department within 4 months of the audit date;

    (b) Make the audit documentation available on-site for inspection by the Department or its designee;

    (c) Conduct an audit in each discipline in which the laboratory performs forensic analyses, using the quality assurance program policies, procedures, and protocols currently in use during the auditing cycle; and

    (d) Conduct a comprehensive evaluation of the overall quality assurance program that includes both administrative and technical services.