US · guidance
CMS SOM App. C, Tag D5205
§493.1233 Standard: Complaint investigations
The laboratory must have a system in place to ensure that it documents all
complaints and problems reported to the laboratory. The laboratory must conduct
investigations of complaints, when appropriate.
Interpretive Guidelines §493.1233
Verify that the laboratory documents all complaints and problems reported to the
laboratory, and that it has a mechanism to determine which complaints require
investigation.
Probes §493.1233
What mechanism does the laboratory have that allows individuals to report complaints or
problems to the laboratory?
How does the laboratory inform laboratory personnel of mechanisms to anonymously
report complaints about laboratory quality to outside agencies, e.g. State survey agencies?
History
Rev. 233; Issued: 09-12-25; Effective: 09-12-25; Implementation: 09-12-25
Provenance
- Source
- cms.gov
- Retrieved
- 2026-07-22
- Edition
- som-2026-07-22
- Content hash
891f8f20fc798efa5dc7ceff4445ea513883a6ce98cbbd7da0eedac09484e4e6
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