CMS SOM App. C, Tag D5207

The laboratory must have a system in place to identify and document problems that

occur as a result of a breakdown in communication between the laboratory and an

authorized person who orders or receives test results.

Interpretive Guidelines §493.1234

Such communication could entail problems with the descriptions they have provided to

authorized individuals about proper specimen collection or shipment. For example, the

laboratory’s system for identifying and documenting communication problems should be

able to capture instances in which there is a need to request additional information

concerning patient specimens. If the laboratory does not receive the appropriate

specimen or patient information needed to perform the tests, the laboratory should assess

whether the information that is currently being made available to authorized individuals

concerning patient preparation, specimen collection, and specimen handling requirements

is adequate.

The laboratory’s system for identifying and documenting communications problems

should be able to capture instances where testing was affected. These instances could be

due to the lack of necessary patient information from the authorized person, improper

specimen collection, improper handling and transport of the specimens to the laboratory,

etc. If the appropriate specimen(s) and/or patient information needed to perform the

requested tests is not being received by the laboratory, an assessment should be made to

determine whether the information that is currently made available to authorized persons

concerning patient preparation, specimen collection, and specimen handling

requirements, is adequate.