Regulation .12 Case Records.
Regulation .12 Case Records.LinkCopy Citation
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.
In 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.