US · guidance
CMS SOM App. C, Tag D6179
§493.1495 Standard: Testing personnel responsibilities
(b)(5) Be capable of identifying problems that may adversely affect test performance
or reporting of test results and either must correct the problems or immediately
notify the general supervisor, technical supervisor, clinical consultant, or director;
Interpretive Guidelines §493.1495(b)(5):
If, during the survey, testing personnel demonstrate an inability to identify a problem that
adversely affects a patient test result, cite D6102 §493.1445(e)(12) under the director
responsibilities.
Some examples of problems that may adversely affect patient test results may include:
• A pleural fluid that is mislabeled as a urine specimen and, therefore, is cultured as
a urine culture;
• Performing a potassium on a hemolyzed sample; or
• Tests are incubated at 37°C when the manufacturer’s instructions require 25°C
incubation.
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
2ad3f556b2f55597c5a78e7aa5f1352e036a25c64a6a17e94563955e00d52d6b
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