1. Instrument Setup and Validation
Presented by: Johns Hopkins Hospital
Project Overview – Greg Rex, Project Lead
Core Lab – Mary McCoy, Application Coordinator
Micro – Brian Glanz, Application Coordinator

2. Project Overview

3. JHH History and Key Facts
Aging in-house developed system (1977)
Extensive customization for Johns Hopkins
In-house programming & support staff
Record Go-Live Moves for any Soft Client (7)!!
Process Started in December 2004 with Go-Live in August 2012
Upgrade Early 2014 with new Servers deployed

4. Reasons for Migration at JHH
Increasing difficulty training & retaining 24/7 support
Needs to support a Total Lab Automation System in 2010 (priority queuing, split tracking, emulators).
Increasing demands by regulatory and accrediting agencies.
System economies across JHH, BMC, HCGH, Sibley and Suburban
Optimize use of rule-based logic to improve service levels.
Migration to “paperless” laboratories.

5. Time Line for Soft LIS
Directors Vision for Commercial Micro LIS
Financial Approval, RFP Process
Added Laboratory Module Replacement
Project Started in January 4.0 line
Project suspended August
Project restart May line
2011/ Multiple version upgrades to
LIVE August 11, 2012 at 13:12
Server Replacement, upgrade, Multisites

6. LIS Version 4.5.x Sites Migrating to the 4.5.x Software Line
Mayo Medical
University of Michigan
Ochsner (Epic)
Montefiore Health System
Other Future Sites

7. Daily Statistics at JHH
JHH Numbers
Daily Orders: 16,190
Daily Results: 112,692
Orderable Tests:
Daily 24,841
Weekly 163,461
Yearly 8,500,000
All Multisite’s will double current volumes

8. JHH – LIS State in 2012

9. LIS Timeline

10. 2016 Proposed State (Draft)

11. Instruments Total of 63 Epicenter Seimens BCS (3) Variant Turbo (2)
Thermo Mass Spec (2)
Molis WAM
4 Instruments and TS-2000 Robotics Interface
Cellavision (2)
Roche DI
C502 (2)
C602 (4)
E701 (4)
Epicenter

12. Core Lab Chemistry

13. Roche Automated Line Roche Robotics (Chemistry) 10 Instruments
106 clinical assays at JHH
P701 (WALLE) specimen storage (27,000 tubes)

14. WALLE
Video

15. “TO DI OR NOT TO DI”…..That is the Question
Special Chemistry
“TO DI OR NOT TO DI”…..That is the Question
DI = Data Innovations Manager
Manages aliquoting of sample
Manages resulting rules and QC
Manages auto verification to Soft

16. Roche Connected Analyzers
Sample aliquoted by Roche Automated Line
QC and Patient results are managed by DI
All results are auto verified to Soft through one Roche Interface

17. Non Connected Analyzers
Sample aliquoted by Roche Automated Line
QC and Patient results are managed by Soft
Separate Soft interfaces for each analyzer
Tosoh - 3
Centaur - 1
Access – 3
Mass Spec – 2

18. Validation Laboratory Staff – Super User Concept
Each QC – pass and fail
Each test - all value ranges
Flagging of results
Documentation
Screen Shots
Instant Reports

19. DOCUMENTATION

20. HURDLES

21. BARCODING DILEMMA Solution
Roche MPA generated processing barcodes – not unique-same as collection barcodes
Soft interfaces require unique processing barcodes
Solution
Soft downloads instrument ID to Roche
Roche adds 2 characters to the processing labels if instrument is unconnected.

22. VOLUME TESTING DILEMMA
When to test with minimal interruption to patient care
Staffing – needed extra staff for testing Soft
Vendor access required in real time (Saturdays)
SOLUTIONS
Weekends
Super users
Overtime
Food
Vendor willing to be accessible on Saturdays

23. Critical Action Value Conflicts
2 different systems evaluating for panics
BEWARE- 2 levels of Patient Type
Stay level patient type – does not change as patient moves during the stay (typically)
Clinic level patient type – follows the patient throughout the stay
SOLUTION
Consult with your implementer regarding hosparam settings

24. THE MASS SPEC CHALLENGE
No Interface Specifications from Our Instrument Vendor
SOLUTION
Lots of information gathering
Trial and Error Interface Development
No direct network connection
SCC Soft meeting with JHH LAN Group. Brainstorming resulted in 2 Shared folders on the network – Soft in and Soft out

25. Challenges Continue No barcode reading but download required SOLUTION
Tasklist designed for downloading patients and QC to
“In” folder

26. Finally - Success

27. SoftMic and Epicenter
Incorporating SoftMic and Epicenter functionalities into the Hopkins Micro workflow

28. JHH Micro Operational Overview
Perform Identification/Susceptibility panels daily
Phoenix panels inoculated manually (no AP)
Expert rules (interpretations; screening rules) maintained on Epicenter for historical reasons (Live in 2006 = 7 years of data)
Soft SD rules used for managing workflow between referral labs within Micro

29. Linking Worklist
Manages receiving, inoculation and downloading of ID/AST panels to Epicenter from a centralized loading station.
Downloading panel consumable from Soft allows for direct loading into Phoenix (no scanning at the instrument)
Built in QC for panel correlation

30. Linking Worklist

31. Linking Worklist – Panel correlation
Built in QC prevents user from loading wrong panel type (Negative, Positive, Strep panels)
Panel setup – Consumable panel prefix

32. Isolate labels
Isolate specific labels linked to various panel types are used to label inoculation broth, Phoenix panel, purity plate and storage slants.
2-D barcode allows for order number, isolate number and panel type to fit on compact label stock.
Soft order #
Isolate #
Panel ID
Label print date/time
Test ID
Body source

33. Interfacing Multiple Panel Types
Added functionality to download and post results to all SoftMic panel types (ID; MIC; BP; KB)
Soft SD rule indicates need for confirmatory testing.
Tech orders panel and refers isolate to “Special Micro” section where additional AST testing is performed, resulted in Epicenter and posted back to SoftMic under the appropriate panel type.

34. Resistance Marker Translation
Soft-Epicenter interface converts organism ID of antibiotic resistant isolates for ease of reporting to Hospital Infection Control department.
Based on combination of organism ID and resistance marker transmitted from Epicenter.
Epicenter ID: STAU (Staphylococcus aureus) Epicenter Resistance marker: RM_MRSA Soft ID: MRSA (Methicillin Resistant Staph. aureus)
*Translation also setup for VRE and ESBL resistance markers

35. MIC Suppression Rule
Epicenter expert rule infers ESBL producer as cefepime resistant, but still reports susceptible MIC to Soft.
Soft MIC suppression rule prevents MIC from reporting.

36. SCR – Not a Dirty Word

37. Questions / Next Steps …..