Data Innovations Regional User Group

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Data Innovations Regional User GroupJune 14, 2017

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Agenda – Regional User Group

Introductions –Jay Sax

Group exercise – Developing Rules - Neal Davis09:45 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 – Jay Sax

Conclusion

EP / IM Integration Training - Colin Deming

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Folder Review


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)


IntroductionsName

Organization

DI Product

LIS

What do you want to get out of today?



Introductions –Jay Sax



01:00 pm

02:15 pm

04:15 pm

9:00 am

9:45 am


Conclusion



Rules ExerciseJune 2017


Rules Exercise #1

• Create a “parent” rule that sets the reference range of WBC to 4.5 – 11.

• What do we mean by “Parent” rule or “Child” rule?


Rules Exercise #1

• Create a “parent” rule that sets the reference range of WBC to 4.5 – 11.

– If: ( {Test Resulted} "WBC" )

– Then: {Set} {Reference Range} {On Test} "WBC" = "4.5" - "11“

• Create a “child” rule that evaluates values below the reference range and adds an L error code if true.

– If: ( ( {Result} {On Test} "WBC" {Is Numeric} ) {AND} ( {Result} {On Test} "WBC" < {Reference Range Low} {On Test} "WBC" ) )

– Then: {Add} {Error Code(s)} "L" {On Test} "WBC“

• Create a “child” rule that evaluates values above the reference range and adds an H error code if true.

– If: ( ( {Result} {On Test} "WBC" {Is Numeric} ) {AND} ( {Result} {On Test} "WBC" > {Reference Range High} {On Test} "WBC" ) )

– Then: {Add} {Error Code(s)} "H" {On Test} "WBC"


Rules Exercise #1

• Test your rules!

• Test a value that should not trigger a reference range violation

• Test a value that should trigger a L reference range violation

• Test a value that should trigger a H reference range violation

• Test a non-numeric value as well


Rules Exercise #2

• Convert your existing reference range rules to use a value list:

– RBC: 4.7 – 6.1

– PLT: 150 - 400


Rules Exercise #2

• Setting up a parent/child value list

– Highlight the Parent rule and look at the Properties pane:


Rules Exercise #2

• Scroll down until you find the Value List Columns row:


Rules Exercise #2

• Define the columns you will be using in your value list.

• In our case, we will use TestCode, RefLow and RefHigh:


Rules Exercise #2

• Now we have Value List columns visible in the Value List tab


Rules Exercise #2

• Next, we need to change the Properties of the Child Rules to use the Parent’s Value List:


Rules Exercise #2

• We need to update our rules to use our new value lists.

– Anywhere we have “WBC”, we will replace that with {Value List:TestCode}

– Anywhere we have “4.5”, we will replace that with {Value List:RefLow}

– Anywhere we have “11”, we will replace that with {Value List:RefHigh}

– Find and Replace can be used for this task, but is not required.


Rules Exercise #2

• Finally, we need to put values in our value list table:

– WBC: 4.5 - 11

– RBC: 4.7 – 6.1

– PLT: 150 - 400

• Parent Rule:

– If: ( {Test Resulted} {Value List:TestCode} )

– Then: {Set} {Reference Range} {On Test} {Value List:TestCode} = {Value List:RefLow} - {Value List:RefHigh}

• Child Rule #1:

– If: ( ( {Result} {On Test} {Value List:TestCode} {Is Numeric} ) {AND} ( {Result} {On Test} {Value List:TestCode} < {Reference Range Low} {On Test} {Value List:TestCode} ) )

– Then: {Add} {Error Code(s)} "L" {On Test} {Value List:TestCode}

• Child Rule #2:

– If: ( ( {Result} {On Test} {Value List:TestCode} {Is Numeric} ) {AND} ( {Result} {On Test} {Value List:TestCode} > {Reference Range High} {On Test} {Value List:TestCode} ) )

– Then: {Add} {Error Code(s)} "H" {On Test} {Value List:TestCode}


Rules Exercise #2

• Value List:


Rules Exercise #2


• Test a value that should not trigger a reference range violation

• Test a value that should trigger a L reference range violation

• Test a value that should trigger a H reference range violation

• Test a non-numeric value as well


Rules Scenario #3

• 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


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


Rules Scenario #4

• The Hematology Department reviews abnormal results in SM Workspaces prior to releasing results to the LIS. They would like a rule to evaluate if RDW is greater than 22.0 to do the following actions:

– hold all tests for verification

– inform the tech within the SM Workspace by adding a Run Comment informing the tech the RDW result is greater than 22.0 and to Scan slide for abnormal RBC Morphology.

• If: ( {Result} {On Test} "RDW" {Is Numeric} ) {AND} ( {Result} {On Test} "RDW" > "22.0" )

• Then: Add requested actions above using appropriate data elements


Rules Exercise #4


• Test a value that should trigger holding all tests with Run Comment

– Ideally use a value that will “Edge Test” the rule just inside of qualifying

• Test a value that should not trigger holding all tests with Run Comment – NegCase

– Ideally use a value that will “Edge Test” the rule just outside of qualifying



Introductions – Jay Sax



01:00 pm

02:15 pm

04:15 pm

9:00 am

11:30 am


Conclusion



Product RoadmapsJune 2017


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 PERL = Product Enhancement Request List

– 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, focused on market problems


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

– Mirroring Technology offers Improvements to Hot Backup (still manual)

High availability offers Automatic failover

– Lab Intel (Business Analytics for the Lab) Look/feel updates

• search capability

• Filters in separate widget

Setup

• Easier import/exporting

• 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)

Coded Entries – force select from dropdown for coded entries

Windows 10 support, Windows Server 2016

Multiple users in the configuration

– APIs Framework, Structure, Security (SSL)

Moving Averages


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

– Moving Averages UI updates

• time on x-axis

• flashing when out of range

• Scroll back in time

Improved Defaults and Configurations

• Edit filters across multiple protocols

• More default protocols

• 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


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 PERL = Product Enhancement Request List

– User interface improvements, where feasible

– Customer-based discussions, focused on market problems


2017 Roadmap – EP Evaluator• Release 12.0 (Estimated 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


2017 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.


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 license renewals


2017 and beyond for EP Evaluator

• Release 12.2 (Estimated Q3 2018) and beyond

– Collaborate with CLSI to adjust EP Evaluator roadmap based on CLSI EP document update roadmap.

– Current target features for EP Evaluator 12.2 includes: 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


Other Roadmap-related Projects, Products

• Devoted Team to 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

• Product Strategy Team

– Pragmatic Marketing model, focusing on market problems

• Will continue the evaluation of market/market problems related to POCT


Questions?Thank you for your time!


Lunch BreakStart back at 1:00 pm






01:00 pm

02:15 pm

04:15 pm

9:00 am

1:00 pm

Customer Key Topic Discussion - Jay Sax

Conclusion


datainnovations.com

ODBC Data Acquisition ProcessUsing EE to connect to IM


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


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. IM will require Specimen Management to support this functionality

• 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)


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


Open the Security Menu


Open the Users and Groups Menu Item


Open the Group Configuration Settings


Add a New Group to Group Configuration

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


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


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


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


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


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


Open a Statmod in EE


Select “ODBC” Data Acquisition




Select the DSN button, Click on System DSN tab


Add a new item, select circled item and then finish


Configure the Data Source screen1) Fill out a name and description (Name can’t have spaces)

2) The 127.0.0.1 address is for systems where IM and EE are installed on the same server or computer. This may need to change if EE is on a separate system from IM. Contact your IM admin or IT for the correct IP Address settings if this needs to change. 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


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


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




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


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


Select the instrument(s) to import data from

Select the instrument in IM to import results from

Note: this is based on the Instrument ID code in IM. Contact your IM admin for any questions on which instrument ID to select.


Instrument ID Code

The instrument list is pulled from the list of Instrument ID Codes in IM. This is similar (though not always the same as) the connections listed in IM, which is what is shown here in comparison.

Contact your IM Admin for questions on which item to select


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 for the selected instrument(s) that are in Specimen Management


Selecting test codes loaded from SM


Specimen filter / selection screen

Certain filters can be applied to the importation of data to help filter out un needed data

If Results intended 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.


Finish the query


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


Select an instrument class


Select the Sample Names


(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.


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.


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


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


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


Opening an Experiment (add or confirm Params)


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


Go back to the overview screen


Recalculate the imported data

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


After Recalculation – pass/fail and other metrics are shown


After Recalculation – Print a report of the new experiments


Printed report example


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


Questions?Thank you for your time!






01:00 pm

02:15 pm

04:15 pm

9:00 am

2:15 pm Customer Key Topic Discussion - Jay Sax

Conclusion



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)






01:00 pm

02:15 pm

04:15 pm

9:00 am

4:15 pm

Customer Key Topic Discussion - Jay Sax

Conclusion



Thank you for attending

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

Documents

Data Innovations Regional User Group