Blood Bank Records Management Must Include Searchability of Patient and Unit History

Every two seconds, someone in the U.S. needs blood. And, at 2,400 blood banks across the United States, the shelf life of platelets and red blood cells are 5 and 42 days, respectively. It makes sense, then, that maintaining accurate records of donors, patients and blood collection information is an essential component of a safe blood supply for our country.

FDA requirements for the collection of blood, blood products and recordkeeping are extremely detailed. According to the FDA, blood bank records must be retained beyond the expiration date for the blood or blood component to facilitate the reporting of any unfavorable clinical reactions. This means individual product records must be retained for no less than 10 years after the records of processing are completed or 6 months after the latest expiration date for the individual product – whichever is the later date. When there is no expiration date, records must be retained indefinitely.

There are also expanded requirements citing that documentation in the patient records must include the identification of individuals who performed each significant step in collection, processing, compatibility testing, and transportation; container qualification/process validations; the final inspection and verification of blood before issue; and blood supplier agreements.

To comply with FDA requirements as well as state and federal record retention guidelines, blood banks need a blood bank records software with searchable history for both patient and blood product unit. When these data elements are stored discretely in a relational database, search, sort and filter capabilities are available. A clinical data platform like HealthData Archiver® offers this functionality in a secure framework that will preserve blood blank records long-term.

Are you decommissioning blood bank software such Soft Bank, SafeTrace Tx, MEDITECH, Sunquest or Mediware as you migrate to Cerner Millennium™ or Epic? Need to make sure all your blood bank record retention requirements, including the ability to search both patient history and unit history, can be met for the long haul?

We’re ready to help.

Dec 18 2019

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