US · guidance
CMS SOM App. C, Tag D3035
§493.1105 Standard: Retention requirements
(a)(3)(ii) Immunohematology records, blood and blood product records, and
transfusion records as specified in 21 CFR 606.160(b)(3)(ii), (b)(3)(iv), (b)(3)(v), and
(d).
Interpretive Guidelines §493.1105(a)(3)(ii)
Refer to the current version of 21 CFR Part 606.160 for the specified section.
Non-transfusion related immunohematology patient testing and quality control (QC)
records, such as instrument function checks, maintenance, and temperature records, must
be retained for at least 2 years.
Other immunohematology patient and QC records related to transfusion testing, including
but not limited to, donor processing, compatibility testing, and transfusion reaction
investigations, must be retained for the time frame stated at 21 CFR §606.160(d). This
also includes the visual inspection of whole blood and red blood cells during storage and
immediately before distribution [21 CFR §606.160(b)(3)(ii)], record of reissue, including
records of proper temperature maintenance [21CFR §606.160(b)(3)(iv)], and emergency
release of blood, including signature of requesting physician obtained before or after
release [21 CFR §606.160(b)(3)(v)].
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
f7a042a2a1f5ca2584ba2c573ecdb08b7440481dcab531f76ea86fb60b38da1e
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