Instrument Setup and Validation Presented by Johns Hopkins

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

Project Overview

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 • • •

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.

Time Line for Soft LIS • • • 2004 - Directors Vision for Commercial Micro LIS 2007 - Financial Approval, RFP Process 2008 - Added Laboratory Module Replacement 2009 - Project Started in January 4. 0 line 2009 - Project suspended August 2010 - Project restart May 4. 5. 2. 3 line 2011/2012 - Multiple version upgrades to 4. 5. 2. 7 2012 - LIVE August 11, 2012 at 13: 12 2013 - Server Replacement, 4. 5. 3 upgrade, Multisites

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

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

JHH – LIS State in 2012

LIS Timeline

2016 Proposed State (Draft)

Instruments • Total of 63 – – Seimens BCS (3) Variant Turbo (2) Thermo Mass Spec (2) Molis WAM • 4 Instruments and TS-2000 Robotics Interface • Cellavision (2) – Roche DI • C 502 (2) • C 602 (4) • E 701 (4) – Epicenter

Core Lab Chemistry

Roche Automated Line • Roche Robotics (Chemistry) – 10 Instruments – 106 clinical assays at JHH – P 701 (WALLE) specimen storage (27, 000 tubes)

WALLE Video

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

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

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

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

DOCUMENTATION

HURDLES

BARCODING DILEMMA • 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.

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

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

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 SOLUTION – SCC Soft meeting with JHH LAN Group. Brainstorming resulted in 2 Shared folders on the network – Soft in and Soft out

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

Finally - Success

Soft. Mic and Epicenter Incorporating Soft. Mic and Epicenter functionalities into the Hopkins Micro workflow

JHH Micro Operational Overview • Perform 200 -250 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

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

Linking Worklist

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

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

Interfacing Multiple Panel Types • Added functionality to download and post results to all Soft. Mic 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 Soft. Mic under the appropriate panel type.

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 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

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.

SCR – Not a Dirty Word

Questions / Next Steps …. . 37