Code of Federal Regulations (Last Updated: May 6, 2024) |
Title 42 - Public Health |
Chapter IV - Centers for Medicare & Medicaid Services, Department of Health and Human Services |
SubChapter G - Standards and Certification |
Part 493 - Laboratory Requirements |
Subpart K - Quality System for Nonwaived Testing |
§ 493.1275 - Standard; Blood and blood products storage facilities.
Latest version.
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(a) The blood and blood products must be stored under appropriate conditions, which include an adequate temperature alarm system that is regularly inspected.
(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period; and
(2) Inspections of the alarm system must be documented.
(b) If blood is stored or maintained for transfusion outside of a monitored refrigerator, the facility must ensure and document that storage conditions, including temperature, are appropriate to prevent deterioration of the blood or blood product.