SURVIVAL TACTICS IN A SEA OF SALTY DATA

Data, data, every where,

Lest tumor boards should shrink;

Data, data, every where,

No time to stop to think.

—with apologies to Winslow Homer and Samuel Taylor Coleridge

Case studiesVermont Project• State-sponsored single payor initiative• Large & diverse partner group

White paper: Bloomberg Highlights Vermont Cancer Pilot; PCD Partners Plays Key HIT Role• Unique care delivery environment

White paper:Perverse Incentives, Clumsy Laws, and the Value/Volume & RVU Conundrum in Medical Quality

Tennessee Project• Large, diverse metropolitan environment• Competitive business landscape

White paper: Decreasing Complexity, Improving Care Quality, and Reducing Cost in Oncology

ContextBoth projects have similar characteristics:

– Large-scale care integration– Payment reform– Clinical improvement & innovation

And similar system requirements:– Data-driven– Process controlled– Continuous improvement

A lot to do and a lot to learn—and quickly

Tools of Industry

ISO-9001

Lean

Six-Sigma

Process maps

Value stream maps

Swim lanes

Kaizen

Ohno circle

Quality

CAPA

ISO-13485

ISO-14972

QMSClinical pathways

Rapid learning system

SOPs

Quality Clinical Care

Process and outcome metrics

Our Approach: QMS Rapid Learning

Tools of Industry Quality Clinical Care

Six-SigmaSOPsLeanOhno circleKaizenSwim lanes

Clinical pathwaysProcess andoutcome metricsCAPAQMSQualityProcess mapsValue stream maps

Rapid learning systemISO-14972ISO-13485ISO-9001Outcome metrics

Process control& efficiency

Data becomes information

RapidLearning

Our Approach: QMS Rapid Learning

Tools of Industry Quality Clinical Care

Six-SigmaSOPsLeanOhno circleKaizenSwim lanes

Clinical pathwaysProcess andoutcome metricsCAPAQMSQualityProcess mapsValue stream maps

Rapid learning systemISO-14972ISO-13485ISO-9001Outcome metrics

Process control& efficiency

Data becomes information

RapidLearningQuality Management

in Complex Systems

White paper: Medical Quality Systems: The Elusive Goal of Quality in Complex Systems

Our Approach: QMS Rapid Learning

Metrics/Quality & Process Change

Process Metrics:• Measure compliance;

almost all metrics are process metrics

Outcomes Metrics• Only viable in context of uniform processes

Who provides these? See A Taxonomy of Leading Oncology Organizations and Patient-Reported Outcomes: Choosing Appropriate Metrics From a Still-Evolving Toolset

CMS

AHRQ, NQF

ASCO, ACS CoC, ACCC, ASTRO, NCCN

Other oncology organizations

Compliance, e.g. multi-modality care planEfficiency, e.g. radiographic imaging incidence, chemotherapy protocol adherenceProcess, e.g. queuing issues, overtime

Drowning in a sea of data: necessary and sufficient?

Cheap to gather.

Large corpus.Matters to Payors and used in ranking.Doesn’t measure anything but itself.Necessary, but not sufficient for improvement.

Small corpus.Valuable only internally and in DTP marketing.

Expensive to gather.

Registries, QOPI, NCCN, Press Ganey, HCHAPS

Does it change cost? Improve process? Change outcomes?

Process/efficiency dataBest practice data

The Trick/Secret Sauce

Integrate documents and data into a single systemNovel functionality of a cloud-based relational database:

• Integrated process definition (ISO) and monitoring with flexible and defined data feeds.

• Yields ISO control and auditability in a data-driven environment; easy to show effectiveness.

• Data model exactly mimics the real world; connects the components of the SOP to the way things truly work.

E.g.: The Problem of Two WorldsRegistries & Best Practice Data Document Management & SOPs

PROs: Meets regulatory requirementsMay improve paymentAffords some comparison within industryEpidemiologically importantFits EMR data fields

CONs:Significant auditing problemsDefinitional variabilityNot process-directedLittle or no impact on outcomes

PROs: Meets regulatory requirementsMay improve paymentAffords some comparison within industryRequired for clinical trials

CONs:Significant auditing problemsDefinitional variabilityNot data-directedFeels like a straight-jacketSits alone, ignored and unloved

Are Green Lights enough?

Process A

Process B

Process C

S T A T U SP R O C E S S

Looks good!

0

20

40

60

80

100

Process A

0

20

40

60

80

100

Process A

0

20

40

60

80

100

Process A

Are problems being addressed? Improvements made?

0

50

100

Process

0

50

100

Outcomes

0

50

100

Outcomes

PROCESS CHANGE

NO CHANGE CHANGE EFFECTIVE

Data-defined process =

Auditable outcome

DASHBOARDS

ProcessData Entry

!

REPORTS

ALERTS

EMR

ProcessDef. & Target

AUDIT REPORTS

rQMS

CARE PLANCollaborative

RLS/QMS = Process Control & ImprovementRequired to make it work:

1. Define the processes & train for competent operation

2. Collect data to monitor process performance & fix issues

3. Audit processes for compliance and improvement needs

4. Improve processes as needed

5. Review the entire system and align with strategy

RLS/QMS in Action

PROCESS

A

CMO OncologyHospital Partner

Management Review

Definition: SOP

T R A I N I N G

D A T A

PROCESS

B

. . .

Monitoring

Audit

Definition: SOP

Monitoring

Audit

repeat

CMA Audit

P C D

QMS

RLS

CMO Oncology

Rapid Learning

PROCESS

A

Definition: SOP . . .

Monitoring

Audit

repeat

Management ReviewStrategic change

Improvement

Fix

M E D I C A L C A R E P A T I E N TC A P A s

P. R.O.

Framing the ProblemHistorical Care / Payment ArrangementsIncentives for More Process StepsTreatment Patterns: Fee for Service

Med Onc

Surg Onc

Rad Onc

$ $ $ $$ $ $ $$ $ $ $

Variable end pointsUncoordinated careUndocumented outcomes

System-optimized for $size and frequency Palliation

Data: chargemaster onlyRCM-optimized

Primary Care $

$

Single planIntegrated care deliveryBest-practice driven

Patient objectivesintegrated

Framing the SolutionChanges in Care Management

Patient

$ $ $Care Plan

PCPPalliationMed OncSurg OncRad OncHospice

System integrates ISO / Lean Six SigmaClinical data confirms protocol compliance

Plan Updates

$

Framing the SolutionISO-style RLS/QMS controls compliance and CAPAs

ISO-STYLE RLS/QMScontrols compliance and CAPAs

CLINICAL PATHWAYSspecify care plan

LEAN & SIX SIGMA optimize care delivery

D A

T A

S T

R E

A M

S

ReportingControl

Spec & Planning

Optimization

Outcomes

ED Off-ramp

PLANNED & EXECUTED CARE DELIVERYPatient-specific

Med Onc, Surg Onc, Rad Onc, Palliation, PCP, Other

Patient

Behind the curtain: the RLS/QMS

Rapid Learning Systemcloud-mandatory

cloud-optional

D A T A S T R E A M S

ExternalData Feeds

EMR& Chargemaster

DataWarehouse

Patient-reported Outcomes

Lean / Six Sigma

ISO-style

PathwaysRules Engine

Care PlanDesign & Implementation