Clients
Healthcare
Electronic Data Systems
Program: Defense Blood Standard Support (DBSS)
The DBSS is a Food and Drug Administration (FDA)-regulated, Class II Medical Device designed to handle blood collection, processing and tracking procedures, and automation of standards and safeguards for the Military Health System (MHS) blood supply. DBSS is also identified by the FDA as a Blood Establishment Software item.
The main goal of DBSS is to ensure a safe blood supply for active duty members and other MHS beneficiaries during wartime, peacetime, and contingency periods of operation. This goal is carried out through DBSS' ability to effectively reduce the risk of transfusion-transmitted diseases to MHS beneficiaries by automatically identifying ineligible donors before their blood is collected.
The DBSS supports the Armed Services Blood Program Office (ASBPO) that manages the blood program for the Department of Defense (DoD), and services more than 8.7 million MHS beneficiaries.
The relationship between EDS and Telophase was and is great! We were always able to work through any issues together. — Bryant Champion, Project Manager, EDS
The Work Performed
Software Development
Telophase was actively involved in the software development process based on EDS' SLC3 methodology and SEI CMM level 3. We spearheaded the training curriculum on the FDA's current Good Manufacturing Practices (cGMP) pertaining to medical device-manufacture, including 21 CFR 820 and the FDA General Principles of Software Validation. Additionally, we designed an interface to regularly upload blood inventory updates to a JMAR (Joint Medical Asset Repository) server. The multi-threaded solution encodes data into a multi-part form and posts it through HTTPS.
Database Management
Telophase provided expertise in building data interfaces (HL7 standards based) to CHCS II (ALTHA), MEQS and other military health data repositories. These interfaces allowed the DBSS application to accurately attribute patient demographic data to their respective medical history. We designed a global database environment by consolidating the individual site databases from over 78 sites. Telophase also established and implemented cleansing and retrieval processes in building and designing the global database.
System Administration
Telophase help establish an annual competency assessment program for system administrators and develop a tri-Service system administrator training program. In addition, we assisted in the planning a policy requiring deployment plans for future DBSS upgrades and have a DBSS reporting capability at all facilities that maintain or transfuse blood products and establish time frames for implementing the latest DBSS software and update the blood program Our systems administrators worked jointly with the customer to develop and implement plans to correct the problems with the Composite Health Care System interface and the Theater DBSS implementation.
The Results
- Accurately attribute patient demographic data to their respective medical history
- Consolidated business rules that were different for each site, and extracting data records from each site's database.
- Established management controls to ensure system requests are processed completely and timely
- Greater efficiency during blood collecting, processing, testing, shipping, and storage.
- Decrease the risk of blood inventory errors
- Enforce data validation rules by specifying them in processes