10.51.02.02

.02 Accredited Forensic Laboratory and Accrediting Organization.

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.