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

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

Voyage into Validation HAVE A PLAN

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

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

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

Voyage into Validation BENEFITS OF TEMPLATES

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

Voyage into Validation PRE-VALIDATION

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

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:________________________

Voyage into Validation

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

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

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

Voyage into Validation POST-VALIDATION

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

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

Voyage into Validation VALIDATION SUMMARY

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

SUMMAry exAMPLE SOFTPATH UPGRADE 4.3.08.12 (Including ASCII Base 4.02.22.3, HIS 4.02.59.1, INST 4.02.48.2, COMMONS 4.1.1.13.5, & SOFT REPORTS 1.1.7.5.1 ) The Vancouver Clinic SoftPath Upgrade was installed in SCC UPG environment on 8-31-09. The version in LIVE was 4.2.3.4.9. At the same time the following were also installed in SCC UPG: PRODUCT                    LIVE                 UPG AIX                              5.3.0.8.2           5.3.0.8.2           ASCII BASE                 4.0.2.21.4          4.02.22.3 HIS                               4.0.2.50.1          4.0.2.59.1 INST                             4.0.2.41.3          4.0.2.48.2 COMMONS                  4.1.1.12.4         4.1.1.13.5 PATH                            4.2.3.4.9           4.3.0.8.12 SOFTREPORTS           1.1.7.0.24          1.1.7.5.1 The following were unchanged in the upgrade project: PRODUCT                    LIVE                 UPG LAB                              4.0.3.13.2          4.0.3.13.2 ORACLE                       10.2.0.4.0          10.2.0.4.0 Release notes were reviewed for applicable functionality and changes. Pre-validation testing was completed on 10-07-09. The testing of the validation scenarios began on 10-09-09 and was completed on 11-30-09. 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 12-14-09. SCC began the install of the upgrade into LIVE at 03:00 12-14-09 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 12-14-09

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

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