10.51.05.05

.05 Standard Operating Procedures Manual (SOPM).

A. Policies and Procedures. A licensee shall ensure that all policies and procedures affecting the scope of activities performed in the laboratory are:

(1) Documented; and

(2) Communicated to, understood by, available to, and implemented by employees performing the activities.

B. A licensee shall ensure that:

(1) Documents issued to employees are reviewed and approved for use by authorized employees before issue;

(2) The current revision status and distribution of documents is established to preclude use of archived documents;

(3) Authorized documents are available at all locations where casework is performed;

(4) Archived documents are promptly removed from access or otherwise identified to ensure against unintended use;

(5) Documents are uniquely identified, including date of issue or version, page numbering, total number of pages or a mark to signify the end of the document, and the issuing authority;

(6) Changes to documents are approved by the same authority that issued the document and altered or new text is clearly identified; and

(7) Documents in computerized systems have equivalent procedures.

C. A licensee shall develop, establish, maintain, implement, and require that technical procedures meet the following:

(1) The procedures included are:

(a) Generally accepted in the appropriate forensic field or supported by data gathered and recorded in a scientific manner;

(b) Available to all appropriate employees;

(c) Able to produce valid and accurate results; and

(d) Reviewed annually by the director or the director’s designee and this review shall be documented;

(2) All procedures include, at a minimum:

(a) Sample or specimen preparation, as needed for the method;

(b) Required quality control, standard, and reference material;

(c) Calibration requirements and instructions;

(d) Interfering substances and potential sources of error;

(e) Literature references;

(f) Special analytical and safety precautions;

(g) Step-by-step instructions; and

(h) Calculations, if required;

(3) The laboratory has a document control procedure to determine when the technical procedure has been discontinued or retired.

(4) A laboratory procedure identifies which documents are to be maintained in the case file;

(5) All changes to a procedure are approved and signed by the director;

(6) The SOPM is available to all forensic analysts and examiners;

(7) A departure from the SOPM is:

(a) Approved by the laboratory director or qualified designee before implementation;

(b) Scientifically validated before implementation;

(c) Written; and

(d) Communicated to the quality assurance manager;

(8) The laboratory has a procedure for determining the reasons, criteria, or conditions for when a report is not produced;

(9) The laboratory has a procedure or policy for technical review of reports that:

(a) Defines criteria for the technical review, for example, number or percent of case reports reviewed or corrective action protocol if discrepancies are found;

(b) Ensures that a review cannot be performed by the examiner or analyst who prepared the report; and

(c) Ensures that a technical review of a one-individual unit is performed at a review percentage determined by the laboratory director by an analyst or examiner of another licensed forensic laboratory, who is qualified within the same disciplines or subdisciplines; and

(10) The laboratory has a procedure for administrative review that:

(a) Requires that reviews be performed on all case reports;

(b) Specifies who may perform the administrative review;

(c) Clearly defines how the administrative review is documented; and

(d) Requires that reviews be performed before case reports are issued.

D. A licensee shall ensure that the laboratory has a policy and procedure for the handling of written or oral complaints received from customers, laboratory employees, or other parties.

E. Postmortem Forensic Toxicology. In addition to applicable sections of this regulation, a laboratory performing postmortem forensic toxicology shall have:

(1) A record of sample signatures and initials of all employees handling specimens and performing analytical work; and

(2) A procedure:

(a) For periodically monitoring the purity of chemicals used as reference standards; and

(b) That defines which postmortem forensic toxicology tests are to be performed on each type of case.