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SoftID.Tx 1.0.0.7. Features and Functionality Presented by: Alan Nichols, MS MT(ASCP). Itinerary for Your Voyage. Transfusion Documentation FDA Paradigms Paradigm shifts SoftID.Tx 1.0.0.7 New features Demonstration Questions.
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SoftID.Tx 1.0.0.7 Features and Functionality Presented by: Alan Nichols, MS MT(ASCP)
Itinerary for Your Voyage • Transfusion Documentation • FDA • Paradigms • Paradigm shifts • SoftID.Tx 1.0.0.7 • New features • Demonstration • Questions
Why a Positive Identification Solution for Blood Transfusion • Patient Safety • Save some trees • Paperless blood pickup functionality • Decrease Resources • Only one nurse to start • Eliminate extra documentation of vitals • Save Money • Avoid Increasing the length of stay • Eliminate potential lawsuits
Transfusion Documentation • SCC’s Recommendation: • SCC recommends that all software systems used to document Transfusion monitoring, have received their 510(k) approval from the FDA. Otherwise, paper documentation should be utilized.
Transfusion Documentation • The following are a few websites that may be of interest: • Discussion on blood administration system: • http://www.pathlabtalk.com/forum/showthread.php?4241-Epic-Transfusion-Administration-System • List of FDA 510(k) approved Blood Establishment Computer Software – lists approved Blood Bank information systems and approved transfusions administration systems • http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/SubstantiallyEquivalent510kDeviceInformation/ucm134987.htm
FDA • The definition of Blood Establishment Computer Software (BECS) includes systems that scan patient barcodes and blood products at point-of-care, i.e., the bedside and issue a warning if the identifiers do not agree, documentation of the user ID of the person hanging the blood, the start and stop time of the transfusion, pre and post vitals and any reaction the patient may have.
FDA Reference • Manufacturers Assistance and Technical Training BranchDivision of Manufacturers Assistance and TrainingOffice of Communication, Outreach and DevelopmentCenter for Biologics Evaluation and Research/FDA301-827-2000 or 301-827-4081800-835-4709Industry.Biologics@fda.gov
Paradigms • Distinct concept • Specific thought patterns • A model • An Exemplar
Paradigm Examples • The Earth is flat • The sun revolves around the Earth • Products from Japan are cheap and poor quality • Nurses can only use one software application.
Tx 1.0.0.7 New Features • Security User database • Single Unit Query(BB25.5.1.0) • No dependency on INST Add on • Courier Assignment controlled in Security or in the User screen in the AC • Disable SSO on a PC
