CMS SOM App. C, Tag D5401

(a) A written procedures manual for all tests, assays, and examinations performed

by the laboratory must be available to, and followed by, laboratory personnel.

Textbooks may supplement but not replace the laboratory’s written procedures for

testing or examining specimens.

Interpretive Guidelines §493.1251(a)

Procedures may be organized in the form of paper-based manuals, or a manual that is

stored in and accessed through computers and/or card files. Use D5403, if the procedure

manual lacks any of the applicable information as specified in §493.1251(b)(1)-(14). If

the laboratory has procedures that are not used for test performance, but are used for

reference purposes, they may be placed in a reference section. You need not review

reference procedures unless problems are identified with patient test results.

Centers for Disease Control and Prevention (CDC) manuals, manufacturer’s operating

instructions, and package inserts, are acceptable provided the policies and procedures are

available, and the methods in use are clearly indicated. If the laboratory modifies any

procedure, the modification must be documented and verified/established as specified in

§493.1253.

Probes §493.1251(a)

How does the laboratory ensure that personnel follow the procedures in the procedure

manual? How are changes in procedures communicated to laboratory personnel? For

competency issues, use D6030 or D6103 as applicable.