Upload
others
View
9
Download
0
Embed Size (px)
Citation preview
Proprietary and Confidential Information. University of Nebraska Medical Center
2007 Microbiology Automation Research Project, Department of DefenseU.S. Army Medical Research and Materiel Command Award No. W81XWH-04-1-090
Microbiology Automation Research Project (MARP)
U.S. Army Medical Research and Materiel Command Award No.
W81XWH-04-1-090
Proprietary and Confidential Information. University of Nebraska Medical Center
2007 Microbiology Automation Research Project, Department of DefenseU.S. Army Medical Research and Materiel Command Award No. W81XWH-04-1-090
Introduction
Project Goal Project Approach Project Tasks & Status Phase II Proposal
Proprietary and Confidential Information. University of Nebraska Medical Center
2007 Microbiology Automation Research Project, Department of DefenseU.S. Army Medical Research and Materiel Command Award No. W81XWH-04-1-090
Project Goal
To develop a specimen transport system that allows incubation to begin at the time of specimen collection, while the patient is in transport
To Create an optimized and automated process for Microorganism culture, identification and sensitivity.
Proprietary and Confidential Information. University of Nebraska Medical Center
2007 Microbiology Automation Research Project, Department of DefenseU.S. Army Medical Research and Materiel Command Award No. W81XWH-04-1-090
Project Approach: Research
Industry Searched to Prevent Duplication Created a Database of Current Technology Evaluated the Work Flow of the Manual Process Determined the Variance in Manual Process Identified Applicable Standards
Proprietary and Confidential Information. University of Nebraska Medical Center
2007 Microbiology Automation Research Project, Department of DefenseU.S. Army Medical Research and Materiel Command Award No. W81XWH-04-1-090
Microbiology Manual Process FlowSpecimen from
Regional Facilities
Specimen from The Nebraska Medical Center
Specimen from other Hospitals
Assign barcode & create computer
entry
Receiving
Microbiology Lab
Print Labels
Sort by Typeof Test
Aerobic Bacterial Culture Anaerobic Culture Mycology Mycobacterium
Blood & Sterile Body Fluids
received in Blood Culture Bottles
STAT tests (Strip tests) Virology Parasitology
Barcode correct & Order in Computer?
Yes
NoCall Appropriate
Person for clarification,
information, etc.
A B C D E F G H
Proprietary and Confidential Information. University of Nebraska Medical Center
2007 Microbiology Automation Research Project, Department of DefenseU.S. Army Medical Research and Materiel Command Award No. W81XWH-04-1-090
Microbiology Workflow Engine
Standardization Approach Dictionary of terms Definition of processes
Overall architecture Action Process Flow Method Process Flow Technique Process Flow
high level approach
in depth level approach
Proprietary and Confidential Information. University of Nebraska Medical Center
2007 Microbiology Automation Research Project, Department of DefenseU.S. Army Medical Research and Materiel Command Award No. W81XWH-04-1-090
Simulation Modeling Approach
Simul8 Modeling Software Real time computer model that mimics the micro lab Visualize the impact of future MARP prototype Accurate numerical result collection
Manual Process Flow vs. Automatic Process Flow Instrument Integration MARP Prototype Integration
Proprietary and Confidential Information. University of Nebraska Medical Center
2007 Microbiology Automation Research Project, Department of DefenseU.S. Army Medical Research and Materiel Command Award No. W81XWH-04-1-090
Site Visits (1/2)
Nebraska Medical Center – Omaha, NE Creighton University Medical Center – Omaha, NE Alegent Health System – Omaha, NE Washington Hospital Center – Washington, DC Nebraska Public Health Laboratory – Omaha, NE University of Chicago Hospital – Chicago, IL Rush-Presbyterian-St. Luke’s Medical Center – Chicago, IL Northwestern Memorial Hospital – Chicago, IL Ehrling Bergquist Hospital – Offutt AFB, NE Mayo Clinic – Rochester, MN Fairview-University Medical Center – Minneapolis, MN The Cleveland Clinic – Cleveland, OH William Beaumont Hospital – Royal Oak, MI Henry Ford Hospital – Detroit, MI
Proprietary and Confidential Information. University of Nebraska Medical Center
2007 Microbiology Automation Research Project, Department of DefenseU.S. Army Medical Research and Materiel Command Award No. W81XWH-04-1-090
Site Visits (2/2)
University of Colorado Hospital – Denver, CO National Jewish Medical and Research Center – Denver, CO Colorado Department of Public Health and Environment – Denver, CO Quest Diagnostics Inc. – Denver, CO Barnes-Jewish Hospital – St. Louis, MO Parkland Memorial Hospital – Dallas, TX Walter Reed Army Medical Center – Washington D.C. Johns Hopkins Hospital – Baltimore, MD University of California, San Diego, Medical Center – San Diego, CA VA Medical Center – San Diego, CA Naval Medical Center – San Diego, CA Centers for Disease Control and Prevention – Atlanta, GA
Proprietary and Confidential Information. University of Nebraska Medical Center
2007 Microbiology Automation Research Project, Department of DefenseU.S. Army Medical Research and Materiel Command Award No. W81XWH-04-1-090
Applicable StandardsClinical Lab Standards
Information Data Type Standards
Regulation Standards Electrical and Mechanical Standards
College of American Pathologists (CAP),
CLIAA
Health Level 7 Interface Standards
(HL7)
Food and Drug Administration (FDA)
Medical Device Design
Underwriters Laboratory (UL)
Centers for Disease Control (CDC)
World Health Organization (WHO)
American Society for Testing and Materials
(ASTM)
International Organization for Standardization
(ISO)
Radio Frequency Identification (RFID)
American Society of Microbiology (ASM)
Clinical and Laboratory Standards
Institute (CLSI)
Clinical Data Interchange Standards
Consortium (CDISC)
Institute of Electrical and Electronics
Engineers (IEEE)
Occupational Safety and Health
Administration (OSHA)
Canadian Standards Association (CSA)
Proprietary and Confidential Information. University of Nebraska Medical Center
2007 Microbiology Automation Research Project, Department of DefenseU.S. Army Medical Research and Materiel Command Award No. W81XWH-04-1-090
Project Approach: Requirements
Following FDA Development Methodology
Telelogic DOORS©
MAP (Microbiology Automation Platform) System Requirements
SCV (Specimen Culture Vehicle) Product Requirements
Proprietary and Confidential Information. University of Nebraska Medical Center
2007 Microbiology Automation Research Project, Department of DefenseU.S. Army Medical Research and Materiel Command Award No. W81XWH-04-1-090
Project Approach: Design
Microbiology Automation Platform (MAP) Software
Telelogic TAU© UML/SysML Modeling Software End-to-End Development Lifecycle Solution Requirements linked from Design through
Testing DODAF (formerly C4ISR AF) Compliant Develop modular design
Hardware Determine Optimal Detection Mechanisms Develop modular hardware design
Specimen Culture Vehicle (SCV) Develop an engine model for versioning
Proprietary and Confidential Information. University of Nebraska Medical Center
2007 Microbiology Automation Research Project, Department of DefenseU.S. Army Medical Research and Materiel Command Award No. W81XWH-04-1-090
System Configuration
Communication Management
Database Management
Event Management Bus
Rul
es E
ngin
e Specimen Introduction
Specimen Preparation
Mgmt
Results Mgmt
Workflow Mgmt Workflow Mgmt
Consumables Mgmt
Workflow Mgmt
Maintenance Mgmt
Remote and GUI
Security Mgmt Safety Mgmt
Transport Management
Workflow Mgmt Workflow MgmtWorkflow Mgmt Workflow MgmtWorkflow
MgmtWorkflow Mgmt
Storage & Retrieval
Mgmt
External SystemsCDC LIS HIS
Data Warehouse Mgmt
Hardware Connectors
Software Connectors
Workflow Mgmt
Device Mgmt
Docking Station
Docking Station
Docking Station
Instrument A
Instrument B
Instrument C
Instrument D
Device 1
Device 2
Docking Station
Docking Station
Docking Station
D
C
B
A
4 3 2 1
D
C
B
A
4 3 2 1
THE DESIGN AND INFORMATION CONTAINED WITHIN THIS DOCUMENT ARE PROPRIETARY AND CONFIDENTIAL. ALL USE, DISCLOSURE, AND/OR REPRODUCTION NOT SPECIFICALLY AUTHORIZED IN WRITING BY THE M.A.R.P. GROUP IS PROHIBITED.
UNIVERSITY OF NEBRASKA MEDICAL CENTER
APPROVED BY
CHECKED BY
DRAWN BY
DATE
DATE
DATE
FSCM NUMBERSHEET
TITLE
DRAWING NUMBER REV
MICROBIOLOGY AUTOMATION RESEARCH PROJECTRTRJ 11/08/2006
11/09/2006
11/09/20061 of 1 900-00202
MAP Subsystems OverviewRSM
MCN
MAP Subsystems Architecture Overview
Proprietary and Confidential Information. University of Nebraska Medical Center
2007 Microbiology Automation Research Project, Department of DefenseU.S. Army Medical Research and Materiel Command Award No. W81XWH-04-1-090
SCV (Specimen Culture Vehicle) Development
Develop size, shape and usability Materials consideration Vendor Search-materials and media Cost estimates of various approaches
Proprietary and Confidential Information. University of Nebraska Medical Center
2007 Microbiology Automation Research Project, Department of DefenseU.S. Army Medical Research and Materiel Command Award No. W81XWH-04-1-090
Initial Design Ideas for Specimen Culture Vehicle (1/3)
Proprietary and Confidential Information. University of Nebraska Medical Center
2006 Microbiology Automation Research Project
Concept Model
Proprietary and Confidential Information. University of Nebraska Medical Center
2006 Microbiology Automation Research Project
Concept Model
Proprietary and Confidential Information. University of Nebraska Medical Center
2006 Microbiology Automation Research Project
Concept Model
Implementation of specimen incubator
Proprietary and Confidential Information. University of Nebraska Medical Center
2007 Microbiology Automation Research Project, Department of DefenseU.S. Army Medical Research and Materiel Command Award No. W81XWH-04-1-090
For use in conjunction with existing detection equipment, e.g. mass-spectroscopy 1 year, $3.5 Million
For use in conjunction with a total microbology automation system. 2 years $8 Million