US · guidance
CMS SOM App. C, Tag D3031
§493.1105 Standard: Retention requirements
(a)(3) Analytic systems records. Retain quality control and patient test records
(including instrument printouts, if applicable) and records documenting all analytic
systems activities specified in §§493.1252 through 493.1289 for at least 2 years. In
addition, retain the following:
Interpretive Guidelines §493.1105(a)(3)
The records must include instrument charts, graphs, printouts, transcribed data, and
manufacturers’ assay information sheets for control and calibration materials. If data are
transcribed, ensure that the original and the transcribed copy are retained for 2 years.
Printouts from an instrument that is not directly interfaced with the laboratory
information system must be retained for 2 years.
NOTE: Thermal paper or pressure sensitive paper may fade over time. Where necessary,
the laboratory is expected to make an electronic or hard copy of applicable result
printouts to ensure that they are retrievable and legible for at least two years.
The laboratory is responsible for retaining records of interpretive slide results of each
gynecologic and nongynecologic cytology case that each cytotechnologist examined or
reviewed for at least five years.
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
1589259b375b4f2f077cb4327a82441f2bdfb8d53aca3010efa32f2395c9c2df
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