This page intentionally left Introduction is a Blood Bank application that facilitates ongoing compliance with Food and Drug Administration (FDA) standards for medical devices and enhances the VA’s 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 2.2.0 introduced a new interface for blood bank testing performed by blood bank instrumentation to VBECS. The implementation of the interface and its associated validation are described in this guide. Unauthorized access or misuse of this system and/or its data is a federal crime. Use of all data must be in accordance with VA security and privacy policies. The U.S. FDA classifies this software as a medical device. Unauthorized modifications will render this device an adulterated medical device under Section 501 of the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act. Acquiring and implementing this software through the Freedom
This page intentionally left Introduction is a Blood Bank application that facilitates ongoing compliance with Food and Drug Administration (FDA) standards for medical devices and enhances the VA’s 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 2.2.0 introduced a new interface for blood bank testing performed by blood bank instrumentation to VBECS. The implementation of the interface and its associated validation are described in this guide. Unauthorized access or misuse of this system and/or its data is a federal crime. Use of all data must be in accordance with VA security and privacy policies. The U.S. FDA classifies this software as a medical device. Unauthorized modifications will render this device an adulterated medical device under Section 501 of the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act. Acquiring and implementing this software through the Freedom
vbecs_2_2_0_provue_config_setup_guide.docx