1. A. A licensee shall create and maintain a unique identifier system for all administrative and examination documents originating from or received by the laboratory for each case by:

   1. (1) Writing all documents in permanent ink and defining exceptions in the laboratory SOPM;
   2. (2) Using electronic signatures only if a security protocol is in place;
   3. (3) Having a tracking policy and system for electronic record changes, when the electronic document is complete; and
   4. (4) Identifying all administrative documents with a unique identifier and signing or initialing by the individual who prepared or received the document.

2. B. In regard to examination documents, a licensee shall ensure that:

   1. (1) If information is recorded on both sides, each side of a page is considered a separate page;
   2. (2) If examination documents consist of multiple pages, a page numbering system that includes either the total number of pages or a mark signifying the end of the document is used;
   3. (3) In the absence of the examiner or analyst, another competent examiner or analyst is able to evaluate and interpret the data;

   4. (4) An examination document:

      1. (a) Includes details to support the conclusions and opinions reported by each examiner or analyst;
      2. (b) Is free of erasures or obliterations;
      3. (c) Is marked with a unique identifier and the examiner’s or analyst’s handwritten initials or electronic signature; and
      4. (d) Includes each date casework or an analysis was performed;
   5. (5) If an individual in addition to the examiner or analyst interprets or reports the results, both individuals initial or electronically sign each page of the examination documents;
   6. (6) Abbreviations and symbols are defined in the SOPM;

   7. (7) Erroneous results, corrections, and amendments:

      1. (a) Are crossed out with a single line, not erased, and not deleted or made illegible; and
      2. (b) Have corrections entered beside the erroneous result;
   8. (8) All corrections and amendments are initialed and dated;
   9. (9) If electronically signed, measures are taken to ensure the signature is secure; and
   10. (10) There is no loss or change of the original documents.

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

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

Regulation .01K amended effective July 20, 2015 (42:14 Md R. 880)

Regulation .02A, B amended effective July 20, 2015 (42:14 Md R. 880)

Regulation .05C amended effective July 20, 2015 (42:14 Md R. 880)

Regulation .07C amended effective July 20, 2015 (42:14 Md R. 880)

Regulation .09C, D amended effective July 20, 2015 (42:14 Md R. 880)

Regulation .10B amended effective July 20, 2015 (42:14 Md R. 880)

Regulation .12B amended effective July 20, 2015 (42:14 Md R. 880)

Regulation .15A, C amended effective July 20, 2015 (42:14 Md R. 880)