Md. Code Regs. 10.51.02.03

Current through Register Vol. 51, No. 22, November 1, 2024

Section 10.51.02.03 - Audits

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.

Md. Code Regs. 10.51.02.03