molecular diagnostics - executive war college · • global molecular diagnostics market to grow at...

Path to the hear t o f hea l thcare

Molecular Diagnostics Positioning the Laboratory for the Future

Through Scalable Lab Developed Test Workflows, Clinical-level Quality, & Operational Efficiency

© 2014 Sunquest Information Systems, Inc. | Confidential and Proprietary

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 2012-20161

•  Global Molecular Diagnostics market to grow at a CAGR of 8.7% from 2014 to 20202

•  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 2012-2016“ http://www.researchandmarkets.com/research/sngbht/global_molecular 2. “In-Vitro Diagnostics (IVD) Market Analysis And Segment Forecasts To 2020” http://www.grandviewresearch.com/industry-analysis/in-vitro-diagnostics-ivd-market.

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

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

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Trends

BioIT World, Clinical Genomics So5ware Short Course by Nazneen Aziz, Director, Molecular Medicine at the CAP, April 2013

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Market Trends in GeneDc Services -‐ Booz Allen Hamilton


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

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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

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Laboratories must scale molecular LDTs with high quality


•  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

Our Clients

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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

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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

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Specimen Tracking •  New orders received?

•  Sample for add-on order?

•  Pull sample for research?

•  Long-term storage location?

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•  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

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• 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

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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

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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

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CAP Checklists

•  Microbiology –  Molecular Microbiology subsection

•  Molecular Pathology •  Cytogenetics •  Molecular Oncology •  Genetics •  Cytopathology •  NextGen Sequencing

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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

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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

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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

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Integration with Other Clinical Systems

Lab Solution Reference Lab

Realtime Dashboards

Management Reporting

Lab Sample Tracking

HIS Physician Order

Specimen Collection

Electronic Sign-out and Patient Reporting

Order Additional Tests

Review Clinical Test Results

Add Results to Final Report

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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

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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

molecular diagnostics - executive war college · • global molecular diagnostics market to grow at...

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