Molecular Diagnostics

Transcription

1 Molecular Diagnostics Positioning the Laboratory for the Future Through Scalable Lab Developed Test Workflows, Clinical-level Quality, & Operational Efficiency Path to the heart of healthcare

2 Change It has been stated that healthcare will experience more change in the next 10 years than it has over the past 50 years and that the following could happen in the next two to six years: Global Molecular Diagnostics market to grow at a CAGR of 11.42% over the period Global Molecular Diagnostics market to grow at a CAGR of 8.7% from 2014 to Global Molecular Diagnostics market to follow the tissue diagnostics segment in terms of growth owing to the growing demand for advanced genetic and HPV diagnostic tests 1. "Global Molecular Diagnostics Market In-Vitro Diagnostics (IVD) Market Analysis And Segment Forecasts To

3 Molecular Dx & Genetics Spend $15 billion - $25 billion projected for 2021 (United Healthcare Study, 2012) 3

4 Infectious Disease Infectious Disease testing is the major volume driver for molecular and genetic test usage (United Healthcare Study, 2012) 4

5 Trends Market Trends in GeneDc Services - Booz Allen Hamilton BioIT World, Clinical Genomics So5ware Short Course by Nazneen Aziz, Director, Molecular Medicine at the CAP, April

6 Oversight of Molecular Dx FDA Authority over LDT but not enforcing it Marketing of reagents CLIA 88 Joint Commission (hospital) College of American Pathologists State health departments American Society of Clinical Pathology 6

7 Impact Assumptions An increasingly large percentage of laboratory work will be via molecular and genetic based testing Improved coding, new care models (ACOs), and payment models (value-based) will drive high value tests and improve the reimbursement situation Regulatory pressures on MDx and LDT quality will mount: FDA, CLIA, CAP Internal medicine/family practice physicians understanding of tests and results will be challenged Specialists and complex cases will increase focus on the comprehensive integrated report Laboratories must scale molecular LDTs with high quality 7

8 Our Clients 300+ LIS clients representing Approximately 140,471 acute care beds 182,640,394 physician office clinical lab tests ordered/year by admitting staff Number ONE Provider for 400+ bed hospitals and AMCs 30% AP LIS share 32% CP LIS 8

9 Strategies Being Employed Paper-based Systems Elegant but not scalable Homegrown Systems High risk for supportability Research-based LIMS Lack patient-centric view Limited Leverage of the LIS Orders and results only 9

10 Non-Integrated Systems Orders and specimen tracking separate databases; not integrated with other clinical specimens LIS used to track specimens to the Lab or to report results, but not to manage the workflow MDx results are not integrated with epidemiology reports, clinical results, and pathology reports Lack Holistic View 10

11 Specimen Tracking New orders received? Sample for add-on order? Pull sample for research? Long-term storage location? 11

12 Non-Integrated Systems Tech time spent on manually entering values and calculations Manual reviewing and transcribing instrument results Entering control values into an excel and creating charts Designing and prepping tray maps Opportunity for error Lower Quality 12

13 Non-Integrated Systems Techs logging activities into various paper logs Inventory levels, lot numbers, expiration dates Slow workflow Limits capacity from expanding to meet the projected demand for molecular testing Poor Scalability 13

14 Areas For Concern or Failure Integration External Molecular LIMS lacks integration with LIS and other clinical systems for seamless sample management and holistic view Efficiency Reduce tech time spent on designing and prepping tray maps, designing master mix, manually entering patient and control values, doing calculations, reviewing raw results, tracking inventory levels, checking reagent lots Quality Manual paper-based workflows have greater opportunities for error Scalability Manual paper-based workflows limit capacity from expanding to meet the projected demand for molecular testing 14

15 Inspections One question at a time Follow the specimen: Show all of the information associated with the specimen within the system Preparing binders for review Searching for anomalies retro-actively Hunting for papers and reports to give inspector People do NOT do well working in multiple systems to do tasks they view as non-essential 15

16 CAP Checklists Microbiology Molecular Microbiology subsection Molecular Pathology Cytogenetics Molecular Oncology Genetics Cytopathology NextGen Sequencing 16

17 Goals Integrate Molecular with other clinical systems Manage complex workflows Incorporate daily tasks into standard workflow Reduce paper-dependent systems Integrated Scalable High Quality Efficient 17

18 Integrate Diagnostic Information Laboratory Information System the primary source of healthcare decision making data integrated information flow Appropriate analytical functionality contained in core operating systems: CP-LIS AP-LIS Functionality contained in pre- and post-analytical workflow modules: Orders and Results (including interfacing and physician portal) Collection Management Client and Courier Management Billing Analytics 18

19 Solution Bring the molecular lab workflow into the clinical setting and into your LIS Take advantage of existing LIS features and maintenance Barcodes Specimen management Workflow control Inventory QC Interfacing 19

20 Integration with Other Clinical Systems Physician Order HIS Specimen Collection Lab Solution Reference Lab Electronic Sign-out and Patient Reporting Management Reporting Realtime Dashboards Lab Sample Tracking Order Additional Tests Review Clinical Test Results Add Results to Final Report 20

21 Always Ready Inspections Documented reports and review available instantly No need to bring out binders for different specimens Integrated protocols and verification means significantly reducing the amount of time spent hunting down inspection information Protocols are enforced and daily activities reviewed by the system 21

22 Top 10 List 5 things to pave way for molecular informatics Establish a strategy for moving to a system that is scalable Ensure high quality by reducing manual steps in your process Leverage the LIS for workflow management and integrated reports Integrate analytical with pre- and post-analytical workflow modules Establish key metrics to measure impact of decisions on operations 5 Things labs to avoid in molecular informatics Operating molecular and genetics laboratory as a silo Manual and paper-based systems which increase opportunity for error Non-integrated IT systems which slow workflow and limit capacity Multiple (commercial or homegrown) solutions in various labs Investments in instrumentation without an informatics plan