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datainnovations.com Confidential datainnovations.com

Data Innovations Regional User GroupApril 12, 2017

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Agenda – Regional User Group

Introductions –Gina Coughlin

Group exercise – Developing Rules - Jeff Piepenburg09:45 am

11:30 am Recent Releases and Product Roadmap – Tawni Reller

01:00 pm

02:15 pm

04:15 pm

9:00 am9:00 am

Customer Key Topic Discussion

Conclusion

EP / IM Integration Training - Colin Deming

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Folder Review

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Customer Key Topic Discussion

• Start thinking about the following items below for the group break out session at the end of the day

• With in your group, rank the top five most important things to you under the following categories. You only need to write down 5 total things and they can be placed under any of the topics

1. Direction of Product Development and enhancements

2. Topics for Regional User Groups, regional 2 day user group and Webinars

3. DI processes and procedures (i.e. support request, upgrading versions)

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IntroductionsName

Organization

DI Product

LIS

What do you want to get out of today?

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Agenda – Regional User Group

Introductions –Gina Coughlin

Group exercise – Developing Rules - Jeff Piepenburg09:45 am

11:30 am Recent Releases and Product Roadmap – Tawni Reller

01:00 pm

02:15 pm

04:15 pm

9:00 am

9:45 am

Customer Key Topic Discussion

Conclusion

EP / IM Integration Training - Colin Deming

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Rules Exercise

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Rules Scenario #1

• Dr. Jones is at a conference this week but still wants to be contacted on his cell phone for any urgent results for his patients. Since it is only temporary, he does not want the hospital contact list updated to reflect this temporary change.

– Create a rule that adds a Specimen Comment with Dr. Jones’ cell phone number (215-555-1234)

– Dr. Jones is identified within Instrument Manager as 456, Jones, James A as the Ordering Physician

– Use the Extract Component of operator

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Using the Extract Component Operator

• The Extract Component Operator looks worse that it really is:

– {Extract Component of} {Ordering Physician} {Using} {Component Delimiter} {From} "1" {To} "1“

– Evaluates the Ordering Physician data element and looks for the “separators” in that field

– 456, Jones, James A 456 is Component 1

The comma is component delimiter or “divider” in this example

Jones is Component 2 in this example

James A is Component 3 in this example

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Rules Scenario #2

• The lab really liked the physician’s contact information being visible in Instrument Manager and is now requesting that all physician’s contact information be listed in Instrument Manager.

– Convert your existing rule in to a rule that uses a value list

– Additional physicians are: 3485, Smith, James M. (215-555-1212)

449, Morgan, Jenny E. (267-867-5309)

888, Bonaire, Vincent L. (317-288-0010)

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Agenda – Regional User Group

Introductions –Gina Coughlin

Group exercise – Developing Rules - Jeff Piepenburg09:45 am

11:30 am Recent Releases and Product Roadmap – Tawni Reller

01:00 pm

02:15 pm

04:15 pm

9:00 am

11:30 am

Customer Key Topic Discussion

Conclusion

EP / IM Integration Training - Colin Deming

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Product RoadmapsApril 2017

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Instrument Manager Overview• Release timelines

Current target is every one major release/launch annually, with a maintenance release 6 – 9 months after the major release

Timing of maintenance release incorporates beta site, early adopter feedback

• Working on 3- and 5-year roadmaps

– Addressing all features/functions within IM Specimen Management, Lab Intel, Moving Averages, Maintenance Manager, etc.

– PERL process/customer-requested enhancements

– User interface enhancements/changes Beginning with Moving Averages in IM v8.16

User requirements for Chemistry and Hematology Workspaces, followed by microbiology/molecular and immunohematology

– Customer-based discussions, market problems

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2016 Roadmap – Instrument Manager• Release 8.15 – Architecture (Q2 2017 – Launch)

– Mirroring Automatic failover – Cache 2015 update

Failover/Async members

– Lab Intel Look/feel updates

• search capability

• Filters in separate widget

Setup

• Listing groups (use across pivots)

• Detail listing updates (columns line up)

New default dashboards available

post-launch

– Additional changes Simplified Traceability - SEL/SMW

SSL communication with client server

SM Index updates (speed improvements –CPU/Disk)

SMW result entry – force select from dropdown for coded entries

Windows 10 support

– APIs Framework, Structure, Security (SSL)

Moving Averages

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2016 Roadmap – Instrument Manager• Release 8.16 (Estimated Q4 2017 – Launch)

– Moving Averages Edit filters across multiple protocols

More default protocols

UI updates

• time on x-axis

• flashing when out of range

• Scroll back in time

• Cleaner, more modern look and feel

Data/documentation in support of launching MA from ‘scratch’

• How to set up protocols, ‘get started’ data on ranges

• How to select tests for use in MA

– FDA 510(k) submission planned

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EP Evaluator Overview• Release timelines

Current target is every 9 months for a release/launch

• Working on 3- and 5-year roadmaps

– Continue incorporating CLSI guidelines as appropriate

– PERL process/customer-requested enhancements

– User interface enhancements/changes? Streamline workflow?

Follow UI changes in IM?

– Customer-based discussions, market problems

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2016 Roadmap – EP Evaluator• Release 12.0 (Q2 2017)

Introduces a new statistical module for Method Comparison that supports the updated CLSI EP9 A3 guideline with the following key features

– 4 different analytical modes depending on intended end user usage: MER, MCV, CCL, WMC

– Allows entry of up to 1 to 5 replicates for X and Y

– Scatter plots Weighted and unweighted OLS Regression

Weighted and unweighted Deming Regression

Passing Bablok

• X with Zero Uncertainty

• X with Nonzero Uncertainty

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2016 Roadmap – EP Evaluator• Release 12.0 Continued

– Bias plots with an optionally displayed mini-histogram

– Outlier detection by extreme studentized deviate technique

– Confidence intervals by Jackknife or Bootstrap sampling

– Preliminary Data Evaluation alerts Prompt user with potential issues with experiment data – whether data has constant SD or

CV, more than 5% outliers, too few specimens, etc.

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2017 Roadmap – EP Evaluator• Release 12.1 (Q4 2017/Q1 2018)

Updates to EP Evaluator based on the most up to date CLSI documents EP05 A3 (Complex Precision) and EP15 A3 (Trueness)

– A new module to support both EP15 A3 and EP05 A3 CLSI EP15 A3 has been updated to be compatible with EP05 single-site study designs

Bias calculations on the same samples used for precision studies

Flexible analysis of variance (ANOVA) to accommodate different experimental designs

• 20 days, 2 runs, 2 reps

• 3 sites, 5 days, 5 reps

– Support studies for Multisite Precision (3 site minimum) for between instrument precision

– Precision verification value = claimed SD Goal plus statistical tolerance limit

Integration with IM for

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2017 and beyond for EP Evaluator

• Release 12.2 (Q3 2018) and beyond

– Continued updates supporting published CLSI documents, including: EP28-A3c: Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory;

Approved Guideline—Third Edition

EP10-A3-AMD: Preliminary Evaluation of Quantitative Clinical Laboratory Measurement Procedures; Approved Guideline—Third Edition

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Other Roadmap-related Projects, Products

• Product Strategy formalized within Data Innovations

– Outside of R&D team

– Pragmatic Marketing model, focusing on market problems

• Evaluation of market/market problems related to POCT

• Collaboration with DI customers

– Onsite visits

– Observation of routine, daily lab workflows, including: use of DI products by lab techs, lab supervisors/managers, lab directors

use of LIS in conjunction with Instrument Manager (Specimen Workspaces, Moving Averages, Lab Intel, etc.)

1:1 in-person discussions between DI Product Strategy and various Lab and IT staff

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Questions?Thank you for your time!

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Lunch BreakStart back at 1:00 pm

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Agenda – Regional User Group

Introductions –Gina Coughlin

Group exercise – Developing Rules - Jeff Piepenburg09:45 am

11:30 am Recent Releases and Product Roadmap – Tawni Reller

01:00 pm

02:15 pm

04:15 pm

9:00 am

1:00 pm

Customer Key Topic Discussion

Conclusion

EP / IM Integration Training - Colin Deming

datainnovations.com

ODBC Data Acquisition ProcessUsing EE to connect to IM

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Objectives

1 Configuration and setup required in IM

2 Configuration and setup required in EE

3 A walk through the query wizard in EE

4 Policies and Parameters and printing a report

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A few terms

• ODBC – Open Database Connectivity

– A protocol that allows transfer of data between two databases, even if those databases are not the same

• IM – Instrument Manager. Version 8.14.10 in the demonstration and in these slides

• EE – EP Evaluator. Version 11.3 in the demonstration and in these slides using the “professional” version license

• RRE – Rapid Results Entry (functionality in EE)

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Configuring Instrument Manager

• In order to establish the ODBC connection between EE and IM, user(s) with proper permissions to access IM via an ODBC connection must be set up

• Since EE users are not always IM users it may make sense to set up users for the specific purpose of using ODBC in EE that do not have access to IM functionality

• The next few slides will detail how to add a new security group and to create a user and assign them to that group

– The user created will be used in EE during ODBC Setup

• Please note the setup for new users or groups only typically needs to occur once and not each time the system is used

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Open the Security Menu

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Open the Users and Groups Menu Item

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Open the Group Configuration Settings

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Add a New Group to Group Configuration

Fill in a group name and description (if desired) then press Enter

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Add a New Group to Group Configuration

1) Select the newly added group entry in the list.

2) Then, click on the ODBC Tab (lower right) and

3)“Check” each options giving the group access to ODBC

1

2

3

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Add a New User

Fill in a desired user name as well as any additional information under Full Name, Description, Email address and then press Enter

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Add a New User

1) Select the new user from the list and then 2) assign the user as a member of the new group we created -EEODBC

1

2

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Add a New User

1) Right click the new user and then 2) click “Set Password” and 3) assign a password to the accountthen select OK

1

2

3

Note: leave “Change on Logon” unchecked

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Transition to EE

• Once a user is created and assigned to a group with ODBC permissions, additional setup in EE needs to occur

• The next few slides will go over setup in EE

• Please note that this is typically a 1-time setup and not intended to occur each time the system is used

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Open a Statmod in EE

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Select “ODBC” Data Acquisition

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Select “ODBC” Data Acquisition

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Select the DSN button, Click on System DSN tab

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Add a new item, select circled item and then finish

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Configure the Data Source screen

1) Fill out a name and description (Name can’t have spaces)

2) The default configuration is intended for systems where IM and EE are installed on the same server or computer, do not change unless required. Add an “IM” to the Cache Namespace section

3) Fill out the ODBC user name we created in IM along with the password we assigned it

1

2

3

5

5) Once steps 1-4 are completed, test the connection to make sure we can connect to IM

4

4) Check this box

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Test the Connection

Once steps 1-4 are completed from the previous slide, test the connection to make sure we can connect to IM. Then click “OK” on the test screen and the main screen

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Collecting Data from IM using EE

• While the previous slides went over a setup and configuration process that likely will not be repeated very often, the next slides go over activity that will likely be repeated numerous times

• The next few slides explain the process of pulling data from IM and into EE using the “RRE” functionality in EE

• RRE interacts with Policies set up on EE. Some of the concepts behind Policies will be discussed at the end of this presentation

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Select “ODBC” Data Acquisition

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Run the Query Wizard

1) Select IM Connection from the first drop down

2) Select the Connection we just created in the middle drop down

3) You may select either Live or Archive data depending on where you want to pull data in IM from in the last drop down

12

3 After 1-3 are done, select the Run Query Wizard button

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Select a date range and other options

Set a date range to encompass the dates of the specimen results to be imported into EE Some additional settings

may be enabled here to further filter specimens that will be imported into EE

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Select the connection(s) to import data from

Select the connection in IM to import results from

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Connections

As shown, the list in the EE Query wizard is pulled from the connection list in IM

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Load test codes to import into EE from IM

1

2

There are two options to select the test codes to import into EE

1- load from a panel (requires some pre-configuration in EE)

Or

2) Load all test codes associated with the connections configuration

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Selecting test codes loaded from configuration

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Specimen filter / selection screen

Certain filters can be applied to import Specimen results that are applicable.

If Specimen required to be imported into EE follow a certain pattern, such as the SpecimenID starts with a value (shown), then these filters can be applied to the query into the IM database.

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Finish the query

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Send the gathered data to EE

The imported data may be reviewed on this screen.

Individual specimen, groups of specimen, or all specimens may be sent to the EE Module on this screen using the ‘Send to SP’ button

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Select an instrument class

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Select the Sample Names

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(optional) Define Reagent/Calibrator information

Note: The values from this screen will appear on the report for the experiment if filled in.

The data can also be filled in later in the Parameters screen inside one of the imported analyte experiments.

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Add an Analyst and a date

Note: The Analyst name and Experiment Date will appear on the report for the experiment.

The values can be modified later in the Parameters screen for an individual experiment if desired.

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Add an optional comment

Note: The comment field will appear on the report and can be modified in the Parameters screen for the experiment at a later time if desired

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The data has been added to EENote: The data has been imported but needs to be “recalculated” to show pass/fail criteria as well as the Number of Samples, Mean, SD, and CV.

The pass/fail criteria is based on settings for an analyte that are either set up in policy definitions or added individually to an experiment via parameters.

Double click an experiment to open it

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Recalculating, Params and Reports

• Now that all of the data has been imported into EE, the individual experiments can be reviewed

• Parameters can be reviewed or edited

• And a report can be printed of either all of the experiments or individually for each experiment

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Opening an Experiment (add or confirm Params)

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Parameters

1

2

3

4

1) The Analyst and Date values were pulled in from the Analyst and Date settings configured during the ODBC acquisition process

2) The pass/fail criteria can either be set manually per experiment or be defined with Policies for instruments/analytes

3) The QC Material settings are optionally added during ODBC Data acquisition

4) The comment is optionally added during ODBC Data acquisition

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Go back to the overview screen

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Recalculate the imported data

Once pass/fail criteria and other Parameters have been set or confirmed, the imported data needs to be recalculated.

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After Recalculation – pass/fail and other metrics are shown

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After Recalculation – Print a report of the new experiments

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Printed report example

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Sanford Health

• Ability to easily & selectively import data from IM into EP Evaluator.

• Reduce time for data entry from days to seconds• Instrument-to-Instrument comparison

from 10 hours to 3 seconds

• Total time to import data, the analysis and printing of reports only a few minutes

• EP Evaluator • Produces ‘inspector-ready’ reports that

are clear and concise • Reports are easy to interpret by the

regulatory agencies’ laboratory inspection team.

Profile:

Type: Non-profit, integrated health care delivery system

Specialties: • Top 100 for Cardiac Care• Nationally ranked Children’s Hospital• Level II trauma center Bed

Size: • 43 hospitals and 250 clinics • 600 Beds• 4 Reference (core) laboratories

Discipline: Chemistry

Volume: 4 million tests annually3 million in clinical chemistry

Instrumentation: Abbott Architect

Time to import, the analysis & printing of regulatory reports is minutes vs. days

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Questions?Thank you for your time!

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Agenda – Regional User Group

Introductions –Gina Coughlin

Group exercise – Developing Rules - Jeff Piepenburg09:45 am

11:30 am Recent Releases and Product Roadmap – Tawni Reller

01:00 pm

02:15 pm

04:15 pm

9:00 am

2:15 pm Customer Key Topic Discussion

Conclusion

EP / IM Integration Training - Colin Deming

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Customer Key Topic Discussion

• Start thinking about the following items below for the group break out session at the end of the day

• With in your group, rank the top five most important things to you under the following categories. You only need to write down 5 total things and they can be placed under any of the topics

1. Direction of Product Development and enhancements

2. Topics for Regional User Groups, regional 2 day user group and Webinars

3. DI processes and procedures (i.e. support request, upgrading versions)

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Agenda – Regional User Group

Introductions –Gina Coughlin

Group exercise – Developing Rules - Jeff Piepenburg09:45 am

11:30 am Recent Releases and Product Roadmap – Tawni Reller

01:00 pm

02:15 pm

04:15 pm

9:00 am

4:15 pm

Customer Key Topic Discussion

Conclusion

EP / IM Integration Training - Colin Deming

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Thank you for attending

Please fill out the survey in your folder and leave on the table to be collected

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