1. Voyage into Validation
Launch into Validation with Confidence
Claudia Harrier
The Vancouver Clinic
Vancouver, Washington

2. 1. Have a Plan 2. Benefits of Templates 3. Pre-Validation
Voyage Overview
1. Have a Plan
2. Benefits of Templates
3. Pre-Validation
4. Validation
5. Post-Validation
6. Validation Summary

3. Voyage into Validation
HAVE A PLAN

4. Have a Plan
Understand the Validation Project Major Upgrade for SCC or HIS/EMR Minor Upgrade(Hot Fix)--SCC or HIS Change of Reference Lab New Tests New Instruments New Sites

5. Have a Plan What is changing? Check Release Notes
Check Related Star Tasks
What systems are involved?
EMR
HIS
Reference Lab
Billing System

6. Have a Plan Identify Resources and Staffing
Determine Time Requirements
Dedicate Time for Validation
Identify “Show-Stoppers”
Set a Tentative Go-Live Date

7. Voyage into Validation
BENEFITS OF TEMPLATES

8. Benefits of Templates Identifies important validation points/steps
Is ready when you are
Can be easily amended
Makes you look organized

9. Voyage into Validation
PRE-VALIDATION

10. Pre-Validation Assessment
Assures access to applications
Assures that basic functionality has not been compromised
Assures interface messages are flowing as anticipated

11. Pre-Validation Assessment Form
Pre-Assessment Functionality Check Software/Version:________________
Date
Test
Epic Order #
Ordered in Epic
SCC Order #
Results in Epic
Initials
CBC
RA with Reflex
TSH-Referred
Comments:
The above Upgrade/Change has passed pre-assesment functionality check. Validation testing may commence.
Date _____________________ Approved by:________________________

12. Voyage into Validation

13. Choose tests that validate:
Validation
Choose tests that validate:
All departments
All sites
Instrument-interfaced tests
Manually resulted tests
In-house tests
Group/Individual tests
Reference Lab tests
Tests that reflex
Amended tests
Tests with panic levels
Variety of microbiology tests

14. Functions to Validate Order entry Faxing Call List Keypads RBS
Label Formats
Report Formats
Query
Print Scheduler
Autoreporting
Scanners
Reports
Faxing
Keypads
Security QC
Worklists
Audit Trail
Canned Messages
Calculations
Multi-site/Redirection

15. Validation Form SCC Test ID Epic ID Test Name Scenario Epic # Name
Integrated
SCC
Test ID
Epic ID
Test Name
Scenario
Epic #
Name
Order Date
SCC SoftPath VP #
Tech completed
Professional Completed
Results in Epic?
Expected Cpts to charge
CPTs charged in Epic
Validate Date
Validate Initials 1
2430
% IRON SATURATION PANEL 2 *
2505
17 OH CORTICOSTEROIDS, 24 H URINE-REF
Commercial Ins

16. Voyage into Validation
POST-VALIDATION

17. Post-Validation Finalize Go-Live date Inform all invested parties: SCC
Lab Departments
Reference Lab
HIS Staff
Hospital Staff
Outreach Clients

18. Post-Validation (Post- Go Live) Form
Post-Live Functionality Check Software/Version:______________________________
Date
EPIC ID
In-House Tests
Performed at
Epic Order #
SCC Order #
Results in Epic
Initials
LAB293
CBC-manual result-high & low values-Smear Review
MHEMA
CBC-run on analyzer
LAB239
URC-run on analyzer
MMICR
LAB9980
PTINR-manual result
MCOAG

19. Voyage into Validation
VALIDATION SUMMARY

20. Post-Validation Summary
Purpose
A record of dates
A record of issues for future reference
Overview
Keep notes throughout validation
Write summary of process
Date & sign

21. SUMMAry exAMPLE
SOFTPATH UPGRADE (Including ASCII Base , HIS , INST , COMMONS , & SOFT REPORTS )
The Vancouver Clinic
SoftPath Upgrade was installed in SCC UPG environment on The version in LIVE was At the same time the following were also installed in SCC UPG:
PRODUCT                    LIVE                 UPG
AIX                                                   
ASCII BASE                          
HIS                                        
INST                                      
COMMONS                          
PATH                                      
SOFTREPORTS                    
The following were unchanged in the upgrade project:
PRODUCT                    LIVE                 UPG
LAB                                       
ORACLE                                
Release notes were reviewed for applicable functionality and changes. Pre-validation testing was completed on The testing of the validation scenarios began on and was completed on A hot fix for the assigning of specimen source was installed and validated. Other problems encountered were fixed or were suspended to future releases.
The LIVE SoftPath back-up was completed by The Vancouver Clinic’s IT department at 12:15 am SCC began the install of the upgrade into LIVE at 03: and completed at 06:29. The testing of SoftPath and SoftLab was completed by SCC technical specialists at 6:44 am. A tissue was ordered on a Test Patient to test functionality in LIVE environment. Validation of SoftLab functionality and interface check in LIVE environment was completed at TVC at 7:02 am. The applicable TMS items were updated. Claudia Harrier MLT(ASCP)QLI Software Analyst, LIS

22. I am pleased to attempt to answer your questions.
During the question time, you may download template examples to your jump drive.

23. Thank you for joining me on the Voyage into Validation!
Thanks a Bundle!
Thank you for joining me on the
Voyage into Validation!