Voyage into Validation Launch into Validation with Confidence

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

Voyage Overview • 1. • 2. • 3. • 4. • 5. Have a Plan Benefits of Templates Pre-Validation 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 # CBC RA with Reflex TSHReferred Comments: Results in Epic Initials The above Upgrade/Change has passed pre-assesment functionality check. Validation testing may commence. Date ___________ Approved by: ____________

Voyage into Validation VALIDATION

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 • Call List • 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 I n t e g r a t e # d SCC Ep Test ic Name ID ID 2430 1 2505 2* Scena Epic Na Ord SCC Prof Expe CPT rio # me er # Tec essio Res cted s Vali Dat SCC h nal ults Cpts char ida dat e Soft com Com in to ged te e Path plete Epic char in Dat Initi VP # ed d ? ge Epic e als % IRON SATURA TION PANEL 17 OH CORTIC OSTERO IDS, 24 Comm H URINE- ercial REF 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: _______________ EPIC Perform ID In-House Tests ed at CBC-manual result-high & low LAB 2 values-Smear 93 Review MHEMA LAB 2 CBC-run on 93 analyzer MHEMA LAB 2 URC-run on 39 analyzer MMICR LAB 9 PTINR-manual 980 result MCOAG Date Epic Results Order # SCC Order # in Epic Initials

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 Soft. Path 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 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 ORACLE 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 Soft. Path 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 Soft. Path and Soft. Lab 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 Soft. Lab 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

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

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