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  • Type: Software
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  • Keywords: VBECS, 510k
  • License: Public Domain

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VA Code in Flight Submission - VistA Blood Establishment Computer Software (VBECS) Sustainment Safety and Quality Updates)v2.3.0 Iteration 4, Build 2.3.0.4
Revision: 2.3.0
Please use this identifier to cite or link to this publication: http://hdl.handle.net/10909/11178
VBECS 510k Disclaimer: "This product is a medical device and the VA obtained a 510k clearance from the Food and Drug Administration (FDA) prior to placing these products into production in VA medical facilities. This 510k clearance to market approval only applies for the VA and does not carry over to sources outside of VA. If you elect to use this product, it is your responsibility to obtain a new 510k clearance for the software obtained from Code in Flight and meet all FDA Title 21 Code of Federal Regulations for medical device manufacturers. The Department of Veterans Affairs is in no way liable for any use of this code."

The main purpose of the VistA Blood Establishment Computer Software (VBECS) is to automate the daily processing of blood inventory and patient transfusions in a hospital transfusion service.

VBECS is an improved Blood Bank application that facilitates ongoing compliance with Food and Drug Administration (FDA) standards for medical devices and enhances the Department of Veterans Affairs (VAs) ability to produce high-quality blood products and services to veterans. The system follows blood bank standards, standards of national accrediting agencies, FDA regulations, and VA policies.
VBECS supersedes VistA Blood Bank v5.2 for blood bank operations. VistA Blood Bank v5.2 blood unit records remaining after the transfer of patient information to VBECS are available for reference only and cannot be edited. VistA Blood Bank v5.2 validation records must be maintained for five years after the last of the blood unit records is transferred to VBECS.

VBECS does not support:
• Blood donor collection activities (donor module)
• Direct data entry of antibody identification
• Direct data entry of transfusion reaction workups
• Patient testing, transfusions, and blood components recorded in Legacy VistA are not available in VBECS
• Pediatric blood product preparation
• Printing of blood product labels
• User defined customized queries or reports
• User editing blood product, antigen, antibody, or transfusion reaction tables
• Validation record storage
Revision Version
Submitted By
Submission Date
Certified
Notes
8OIT EPMO EPMD ACOE Tools Operations Open Source Service11-02-2018Adding Docs and Code
7OIT EPMO EPMD ACOE Tools Operations Open Source Service08-30-2018Adding updated code and docs
Iteration1_Build2.3.0.2OIT EPMO EPMD ACOE Tools Operations Open Source Service04-04-2018This revision makes available the in flight source code for v2.3.0, iteration 1, build 2.3.0.2 which is currently under development.
5OIT EPMO EPMD ACOE Tools Operations Open Source Service01-12-2018Adding updated code.
2.3.0OIT EPMO EPMD ACOE Tools Operations Open Source Service10-26-2017This revision makes available the in flight source code for v2.3.0, Iteration 1 Build 2.3.0.1 which is currently under development.
3OIT EPMO EPMD ACOE Tools Operations Open Source Service06-29-2017This revision makes available the in-flight (currently under development) source code for VBECS Sustainment Safety and Quality Updates v2.2.1.2.
2OIT EPMO EPMD ACOE Tools Operations Open Source Service09-27-2016Providing updated source and documentation for v2.2.0
1OIT EPMO EPMD ACOE Tools Operations Open Source Service02-01-2016

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