Microbiology Automation Research Project (MARP)

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



Introduction

Project Goal Project Approach Project Tasks & Status Phase II Proposal



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.



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



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



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



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



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



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



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)



Project Approach: Requirements

Following FDA Development Methodology

Telelogic DOORS©

MAP (Microbiology Automation Platform) System Requirements

SCV (Specimen Culture Vehicle) Product Requirements



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



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



SCV (Specimen Culture Vehicle) Development

Develop size, shape and usability Materials consideration Vendor Search-materials and media Cost estimates of various approaches



Initial Design Ideas for Specimen Culture Vehicle (1/3)


2006 Microbiology Automation Research Project

Concept Model



Concept Model



Concept Model

Implementation of specimen incubator



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

Documents

Microbiology Automation Research Project (MARP)