Md. Code Regs. 10.51.05.12

Current through Register Vol. 51, No. 25, December 13, 2024

Section 10.51.05.12 - Case Records

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) Writing all documents in permanent ink and defining exceptions in the laboratory SOPM;

(2) Using electronic signatures only if a security protocol is in place;

(3) Having a tracking policy and system for electronic record changes, when the electronic document is complete; and

(4) Identifying all administrative documents with a unique identifier and signing or initialing by the individual who prepared or received the document.

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

(1) If information is recorded on both sides, each side of a page is considered a separate page;

(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) In the absence of the examiner or analyst, another competent examiner or analyst is able to evaluate and interpret the data;

(4) An examination document:

(a) Includes details to support the conclusions and opinions reported by each examiner or analyst;

(b) Is free of erasures or obliterations;

(c) Is marked with a unique identifier and the examiner's or analyst's handwritten initials or electronic signature; and

(d) Includes each date casework or an analysis was performed;

(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) Abbreviations and symbols are defined in the SOPM;

(7) Erroneous results, corrections, and amendments:

(a) Are crossed out with a single line, not erased, and not deleted or made illegible; and

(b) Have corrections entered beside the erroneous result;

(8) All corrections and amendments are initialed and dated;

(9) If electronically signed, measures are taken to ensure the signature is secure; and

(10) There is no loss or change of the original documents.

Md. Code Regs. 10.51.05.12

Regulation .12 amended effective 42:14 Md. R. 880, eff.7/20/2015