Decentralized Testing: The New World Order

Greg Lyons & Nancy Stoker Orchard Software Corporation

June 21, 2018

1. Define decentralized testing.

2. Clarify decentralized testing workflow.

3. Discuss workflow management considerations.

4. Examine various testing modalities.

5. Evaluate new and emerging technologies.

6. Review testing economics.

7. Coordinate patient data using software.

Learning Objectives

Topics • Terminology • Defining Workflows • Management • Differing Modalities • Laboratory Trends • Testing Economics • Coordinating Patient Data Using Software

Former Laboratory Managers:

• Nancy was a microbiology manager and multi-specialty group lab manager

• Greg was a hematology/oncology laboratory manager

HOW DID WE GET HERE?

A Bit of Disclosure

Terminology • Solicited vs. Unsolicited • Near-patient Testing vs. Bedside Testing

What are we doing?

http://www.heftone.com/recordings/down_home_rag_uke.mp3

Decentralized Testing Key drivers of decentralized lab testing: • Managing chronic diseases

– Diabetes

– Cardiac

Decentralized Testing • The increasing virulence

of infectious diseases

• The need for better drug monitoring for diseases such as cancer • The advances in technology

making laboratory testing more portable and “dummy proof”

• Solicited Orders – Orders are placed and sent from

host system (EMR) – Straightforward – Core lab very comfortable with workflow

• Unsolicited Orders

– No host orders exist, anywhere – More common in hospitals – Dependent upon HIS/EMR

ability to accept unsolicited results – Handheld devices that move from

patient to patient

Orders: Solicited vs. Unsolicited

• Near-patient Testing – Usually outpatient sites, such as

clinics and physician office labs – Testing site consolidation – Could be inpatient STAT lab

or hospital ER lab

• Bedside Testing

– Usually hospital inpatients – Could be outpatient but

performed “at the patient side”

Near-patient vs. Bedside

Defining Workflows • Solicited Orders to Near-patient Testing Location • Unsolicited Orders Performed at Patient Bedside

Solicited Near-patient Testing

Example: Automated CBC in Oncology Clinic

• Order for CBC placed via EMR • RN or MA runs CBC on analyzer • Results transmit to EMR • Decision made on therapy

Solicited Near-patient Testing

Management Considerations:

• Someone monitors QC

• Someone manages operator certifications or competencies

• Where does that “someone” live?

• It’s all about the NOUNS: Who, What, Where

Solicited Near-patient Testing

Common near-patient testing: • Urine strip readers • Urine pregnancy • Rapid flu • Hgb A1c • Basic chemistries • Cholesterol and lipids • Hemoglobin • CBC

Solicited Near-patient Testing

Unsolicited Bedside Testing

Glucose Monitoring of Hospital Inpatients • Glucose monitored 4x per day but no host order is

sent to the laboratory information system

• Patient’s finger stuck and glucose performed

• Decision made on therapy

• Results make it to EMR “magically”

Unsolicited Bedside Testing

Management Considerations:

• Non-laboratorians running the test

• Initial, 6-month, annual certification cycles

• Expired certification status sent to device

• If a certification is expired, the device can lock out the operator!

• It’s all about the NOUNS: Who, What, Where

Unsolicited Bedside Testing

Common bedside testing: • Glucose • Creatinine • Lactate • Electrolytes • Cardiac markers • Pregnancy • Coagulation • Blood gases

Unsolicited Bedside Testing

Management • Who? • Where? • What?

• Laboratory

• Respiratory Therapy

• Nursing

• Pharmacy

WHO

• Tests

• Instruments

• Kits

• Strips

WHAT

• Bedside

• Ancillary Departments

• Clinics

• Physician Offices

• Pharmacy

WHERE

• Industry consolidation means more remote testing sites – What is considered remote?

– Is the testing taking place across the hall or in another state?

• As devices become more advanced, their use in the

outpatient arena is increasing

WHERE, continued

Differing Modalities • Consumer-based Modalities • Impact of Technology

• At-home Testing – Traditional: glucose, urine, pregnancy, prothrombin time

– Newer: hemoglobin, hemoglobin A1C, drug screening, colon

cancer screening, cholesterol, and more

Lab Testing Modalities

• At-home Sample Collection

– Kits for mail-out testing

– STDs, allergies, cholesterol, lipids, DNA, paternity, hormones, vitamins, and more

Lab Testing Modalities

• Retail Pharmacy Clinics

– Pharmacist testing

– Increased consumer demand for walk-in clinic services

Lab Testing Modalities

Advances in Technology • Processing and analyzing

• Testing made simpler and smaller

– Microfluidics for CTC

• Patient self-education

Decentralized Molecular “As personalized medicine continues to advance, bringing molecular diagnostic testing to the point of care in the physician’s office will continue to be in demand.”

*GenomeWeb. “Decentralized MDx Testing Gaining Steam but Obstacles Remain, Industry Execs Say.” December 2008. Retrieved from: www.genomeweb.com/decentralized-mdx-testing-gaining-steam-obstacles-remain-industry-execs-say.

• The range of disciplines and use cases for which POC testing is a suitable option has expanded dramatically over the past decade, driven by advances in detection technologies and electronics

Expanded Capabilities

Quote and image source: Kate McLaughlin, PhD, and Donna Hochberg, PhD, “Horizons in Point-of-Care Testing,” November 30, 2017, Retrieved from: http://www.clpmag.com/2017/11/horizons-point-care-testing/?ref=fr-title on June 1, 2016.

– More recently developed POC platforms apply on a smaller scale the same principles as high-throughput core lab instruments

– Many are capable of executing complex protocols that include centrifugation, washing, and multiple reagent incubations in a self-contained disposable format

Advanced Functions

Quote and image source: Kate McLaughlin, PhD and Donna Hochberg, PhD, “Horizons in Point-of-Care Testing,” November 30, 2017. Retrieved from: http://www.clpmag.com/2017/11/horizons-point-care-testing/?ref=fr-title on June 1, 2016.

On the Horizon

Image source: Kate McLaughlin, PhD and Donna Hochberg, PhD, “Horizons in Point-of-Care Testing,” November 30, 2017. Retrieved from: http://www.clpmag.com/2017/11/horizons-point-care-testing/?ref=fr-title on June 1, 2016.

Portable & Smaller

• Testing Meters

• Smart Phones

• Smart Watches

Wearable • Continuous Glucose Monitoring

– Patch or smart watch

– Can be used in conjunction

with insulin pump to make automatic adjustments

– Data can be shared with healthcare provider

Image Source: The Diabetes Council. 2018. Retrieved From: https://www.thediabetescouncil.com/continuous-glucose-monitoring-everything-you-need-to-know/

• Other modalities in development

– Glucose monitoring contact lenses

– Bio-sensitive tattoo inks

– Implanted bio-sensors

– Who knows what is next!

Micro-wearable

Now Back to Reality…

Laboratory Trends • Patient Care • Quality • Billing

• As healthcare becomes more consumer-focused, the need for convenient diagnosis, monitoring, and screening tests is expanding

• Focus on improved patient outcomes and OVERALL cost of healthcare is considered, not traditional laboratory cost-per-test model

Laboratory Trends

• Test Quality – Are your remote testing sites

manually entering results to the EMR?

– Have you discovered errors?

– Is QC being performed?

Laboratory Trends

WHAT ARE THE RESOURCE COSTS OF MANUALLY MANAGING THESE ACTIVITIES?

• People Quality: Certifications

• Documentation that all personnel are qualified to perform testing

Laboratory Trends

• Billing – How are you billing for these tests?

– ARE you billing for these tests?

– If you are dependent upon manual

entry to the EMR….

Laboratory Trends

ARE YOU SURE YOU’RE CAPTURING ALL CHARGES?

Why is this important?

• Electronically capturing quality measures (QC and certification are just a start)

• Capturing charges for ALL testing events ensures your payors will have the quantity metrics along with the quality metrics

Laboratory Trends

Testing Economics • Point-of-Care Value Proposition

=

Point-of-Care Value Equation

VALUE CLINICAL OUTCOME

COST

Clinical validity, utility, and improved patient experience

• Improve chronic disease monitoring

• Decrease admissions/readmissions

• Face-to-face interaction with provider for more personalized approach

Clinical Outcomes

• Better monitoring = improved outcomes

• Improved outcomes = better reimbursements

• Improved outcomes with shared risk contracts = more dollars back to your organization

Value

Go back to the NOUNS:

• WHO is doing the testing?

• WHERE are they doing the testing?

• WHAT are they testing?

Cost Factors in Value Proposition

• Core laboratory is used to measuring cost per test

• Cost per test often higher in POCT testing

• In the Point-of-Care Value Proposition, it is one element, not the sole element

Cost

• Are your contracted insurance carriers requiring more data from you? – CPT: Category II codes

– Date-time: Operator stamps for

non-laboratory tests?

– Proof of training and certification

• These items will be the foundation for insurance carriers managing outcomes-based medicine and accompanying claims

Shared Risk Contracts

• Use CPT code rules to assign CPT-II

Comprehensive Diabetes Care

• Are you thinking outside the traditional lab testing box?

• Can you leverage your powerful LIS to manage data not typically associated with lab?

• Will managing this data help your organization bottom line?

Closing Care Gap: Can Lab Help?

• Diabetic Eye Exam

Let’s Think Outside the Box

If device has the capability…

• INTERFACE!

Acceptance is KEY

• The data contained within your laboratory information system is the currency that drives your organization

Data is the New Currency

• How do insurance companies look at your data?

• CPT-II codes to close care gap – HEDIS and Star Ratings

• Better (more complete) data = higher reimbursement

• POCT and core laboratory results

• Testing data that mirrors laboratory data but performed outside

the laboratory

Evaluating Data

CPT-II in Harvest: Conditions

CPT-II in Harvest: Actions

• On roadmap for Q1 2019

CPT-II in Trellis or Copia

Coordinating Patient Data Using Software • Population Health Management • Laboratory Analytics

Population Health Management

Lab's Opportunities in PHM

Development of PHM analytics and

algorithms that include lab results

Decisions regarding POCT

implementation to improve patient

engagement

As clinical consultants on a

PHM team, designing EHR rules and other alerts to trigger care

interventions

Supporting providers in QPP quality

measure reporting

• Labs can help providers meet quality measures, improving quality of care for patients

• HOW? – Live Dashboard Quality Management

– Data Mining

– Automated Reporting

Quality Measures

Dashboard Quality Management

• As accountable care organizations and integrated delivery networks (IDNs) continue to develop, more testing will be performed outside of the core lab, in ambulatory settings and decentralized locations

• Shared data can reduce duplicate testing, readmissions, and more

• If all data, including decentralized lab and self-testing results, are included in the data, all the better

Information Exchange

Data Mining

• Still thinking outside the box?

• Can you leverage your LIS to include non-traditional laboratory data?

Negotiate Insurance Contracts

• Identify your highest-risk patient populations

• Monitor frequency and timeliness of tests needed for chronic disease – Comprehensive diabetes care

– Low-density lipoprotein cholesterol

– Prenatal care

Use Data to Improve Outcomes

• Patient engagement is vital to an effective PHM program – Where can decentralized testing best serve the patient

population, and how are those results are integrated into analytics for PHM risk stratification?

– Decentralized lab and patient testing have been shown to increase patient engagement

Patient Engagement

• Home meter clinics

• Compare home results to POCT or core lab results

• Face-to-face interaction

Patient Engagement

• Hospital consolidation to create larger systems

• Industry standardization

• Big data, cloud-based storage, hosted systems, and other emerging technologies make interoperability easier than ever

Interoperability

1. Defined decentralized testing.

2. Clarified decentralized testing workflow.

3. Discussed workflow management considerations.

4. Examined various testing modalities.

5. Evaluated new and emerging technologies.

6. Reviewed testing economics.

7. Coordinated patient data using software.

Learning Objectives Review

• Patti Hines (University Hospitals)

• Judy Thompson (Washington Hospital)

• Tim Townsend (Brookwood Baptist Health)

Next: POCT Panel Discussion

Thank you!

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• Program Title: Day 2 Orchard Symposium 2018

• Speakers: Beth Eder, Chris Lamb, Clair Smith, Greg Lyons, Gwenn Brode, John Miller, Judy Thompson, Karen Abara, Kim Futrell, Leigh Boje, Nancy Stoker, Nicole Carter, Patti Hines, Ryan Howard, Tim Townsend, Yuri Dozier

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