2/7/08Group 7- Lauren Knish, Ross Morrison, Stuart Reasons 2008 Group 7: Healthcare, Barcoding and Safety – Beyond Medication Lauren Knish, Ross Morrison, Stuart Reasons Advisors: Patrick Harris and David Roth, Pharma-Sys Inc.

2/7/08Group 7- Lauren Knish, Ross Morrison, Stuart Reasons About PharmaSys Inc. PharmaSys is an international full service contract compliance and validation firm specializing in industries that must comply with 21 CFR (Pharmaceuticals, Bioscience, Medical Devices and Clinical Trials), based in Cary, North Carolina. PharmaSys has recently begun creating a bedside verification system called eMeds. Our advisor Patrick Harris is the product director of the eMeds system.

2/7/08Group 7- Lauren Knish, Ross Morrison, Stuart Reasons Background Point of care bedside verification systems have drastically reduced the amount of errors in medication delivery as well as specimen collection and blood transfusion These systems can be implemented using RFID systems, barcoding and many related technologies

2/7/08Group 7- Lauren Knish, Ross Morrison, Stuart Reasons Benefits Improves patient and medication safety Cost savings by elimination of mal-practice lawsuits Cuts down on paperwork Ensures patients of “five rights” before medication (right patient, right drug, right time, right dose, right administration route) Connects the operations of pharmacy, physician, nurses and administration

2/7/08Group 7- Lauren Knish, Ross Morrison, Stuart Reasons Last Years Group Created a system of prototypes to verify drug delivery in hospitals We are adding modules with functionality that includes Blood Transfusion and Specimen Collection Our work will help make the system more robust and universal The work from last years group is currently being tested in Pungo District Hospital in Pungo, North Carolina

Software Development Guidlines I.SQAP – Software Quality Assurance (plan) II.SRS – Software Requirements Specification III.Fitts Law

Software Design SQAP – Software Quality Assurance (plan) Planned systematic patterns of activities performed to assure the procedures, tools and techniques used during software development are adequate to provide the desired level of confidence in the final product. Purpose: To assure the software is of such quality that it does not reduce the reliability of the device. Includes checks and balances (p. 78) King, Paul, Richard C. Fries. Design of Biomedical Devices and Systems. New York: Marcel Dekker, 2003.

Software Design SRS – Software Requirements Specification A specification for a particular software product, program or set of programs that perform certain functions. A good SRS is: Unambiguous, complete, verifiable, consistent, modifiable, traceable, and usable during the Operation and Maintenance phase (p. 82) King, Paul, Richard C. Fries. Design of Biomedical Devices and Systems. New York: Marcel Dekker, 2003.

Fitts Law Describes the time taken to acquire a visual target using some kind of manual input device. (mouse/ keyboard etc.) Although there are many variants on Fitts' law the most commonly used is: Mean Time = C1 + C2log2(D/W + 0.5) (1) D - is the distance to the center of the target W - is the target width C1/C2 - are experimentally determined constants. (

2/7/08Group 7- Lauren Knish, Ross Morrison, Stuart Reasons Project Goals Completed Expand the system to provide verification for blood transfusion Expand the system to provide verification for specimen collection Create Activity Databases (TAR, SCAR) **Expand the system to the ER and OR environments of the hospital **Expand the system to provide verification for breast milk delivery **Time permitting

2/7/08Group 7- Lauren Knish, Ross Morrison, Stuart Reasons Current Work Work with Scanner to verify our prototype Creating the Vitals Record pages for both transfusions and specimen collections for pre/post user actions

BLOOD TRANSFUSION WORKFLOW

Use Cases A Use Case describes how the system reacts to a user’s input actions. -Shows how the ISBT–128 (barcode scanner) will respond to any given situation along each step of verification.

2/7/08Group 7- Lauren Knish, Ross Morrison, Stuart Reasons Use Case for Blood Transfusion Alternative Actions (optional note attachment) Exceptions (something doesn’t check on the blood sample) A Use Case has also been created dealing with Specimen Collection

2/7/08Group 7- Lauren Knish, Ross Morrison, Stuart Reasons

2/7/08Group 7- Lauren Knish, Ross Morrison, Stuart Reasons

TAR Transfusion Activity Record

SCAR Specimen Collection Activity Record

2/7/08Group 7- Lauren Knish, Ross Morrison, Stuart Reasons Future Work Polish both Blood Transfusion and Specimen Collection Prototypes (adding vitals records) Total System Requirements Possible Tabs to add: –If patient denies action- what we should do. –Where administered? –Any reaction to the transfusion? Integrating eMEDS into the hospital environment Continued user friendly prototype design

ISBT 128 2/7/08Group 7- Lauren Knish, Ross Morrison, Stuart Reasons

2/7/08Group 7- Lauren Knish, Ross Morrison, Stuart Reasons Demo!