integrating laboratories–why, when, and how: the good, the

2013 CONTINUING COMPLIANCE MASTER SERIESIntegrating Laboratories – Why, When, and How: The Good, the Bad, and the Ugly

www.cap.org

Paul Urie, MD. PhD, FCAPJune 19, 2013

ObjectivesObjectives

• Identify the benefits, challenges, and common barriers to y , g ,laboratory integration

• Identify laboratory strengths, procedures, organizational y y g , p , gresources, and key laboratory personnel needed to facilitate successful laboratory integration

• Define components of the laboratory integration process to maximize benefits, reduce challenges, avoid pitfalls, and remain friendsand remain friends

2© 2013 College of American Pathologists. All rights reserved.

Why Integrate? Advantages versus Status QuoWhy Integrate? Advantages versus Status Quo

• Individual laboratories

• Hospital system

P th l i t• Pathologists

• Patients


Why Integrate? Individual Laboratory Survival Can Be as Difficult as Flowers Growing in the RocksBe as Difficult as Flowers Growing in the Rocks


Why Integrate? Advantages to LaboratoriesWhy Integrate? Advantages to Laboratories

• Standardize equipment platformsq p p

• Centralize capital equipment acquisition

C t li d ti ti i iti• Centralize vendor negotiations-improves position

• Centralize project oversight and funding

• Centralize supply purchasing and reagent sharing

• Standardize service contracts and maintenanceStandardize service contracts and maintenance agreements

• Lot number sequesters-sharing of QC materials


ot u be sequeste s s a g o QC ate a s


• Standardize SOP’s-development, reviews and revisionsp ,

• Standardize document control

St d di t i i d t• Standardize training and competency

• Standardize QC program

• Standardize regulatory inspections for CAP

• Uniform change control proceduresUniform change control procedures



• Reduce variation-lower costs and error reduction

• Control test menus at facilities to manage utilization

D i t ti t f iliti ith l t t t t• Drive testing to facilities with lowest cost per test

• Uniform service performance to patients-costs

• Enhance marketability of laboratory service to providers

• Centralize esoteric testingCentralize esoteric testing

• Promote inter-laboratory cooperation


Why Integrate? Individual Laboratories Can Be as Lonely as a Lizard on a Rock WallLonely as a Lizard on a Rock Wall


When to Integrate? Current U.S. Federal Debt and Unfunded Liabilities in Trillions of US DollarsUnfunded Liabilities in Trillions of US Dollars


When to Integrate? Example of Utah MedicaidWhen to Integrate? Example of Utah Medicaid


When to Integrate? Commercial InsuranceWhen to Integrate? Commercial Insurance


When to Integrate? Now May be the Time-Accountable Care OrganizationsAccountable Care Organizations

Accountable Care Organization accepts responsibility for g p p ythe quality, cost and overall care of a defined population

“The Healthcare system is fatally flawedy y

Unwarranted variation is the biggest problem

If t h i i i idi hi h litIf we support physicians in providing high quality, evidence-based care (High Value) we will both increase quality and provide care in a financially sustainable manner” (Brent James MD, Intermountain Healthcare)


Polling Question 1

Where is your laboratory in the Integration Cycle?

Polling Question 1

y y g y

© 2012 College of American Pathologists. All rights reserved. 13

Laboratory Integration Can Resemble a Snowy, Cloud Enveloped MountainCloud Enveloped Mountain


When to Integrate-Ready to Overcome Possible ObstaclesObstacles

• Laboratory management of individual labsy g

• Medical director and staff pathologists

M di l t ff d i• Medical staff and nursing

• Hospital administration

• Corporate administration


When to Integrate-Ready to Overcome Possible ObstaclesObstacles

• Individual laboratory history, culture and processesy y, p

• Geographic differences

C t f t l d i t• Cost of travel and courier system

• Different LIS and EMR systems

• Laboratory staff suspicions

• Lack of financial resources to support integrationLack of financial resources to support integration


Pathway to Integration May Require Reading Hieroglyphs on a Sandstone Rock WallHieroglyphs on a Sandstone Rock Wall


When to Integrate-How to Overcome ObstaclesWhen to Integrate How to Overcome Obstacles

• Identify and promote leaders-pathologists and y p p gmanagement

• Clearly articulate advantages of integrationy g g

• Provide accurate financial data on current laboratory operationsp

• Create a financial model for integrated laboratory service based upon reasonable assumptions

• Frequent communications with stakeholders


Polling Question 2

What does SWOT stand for?

Polling Question 2


How to Integrate Laboratories-Suggested ProcessHow to Integrate Laboratories Suggested Process

• Perform cost assessment and benefit analysisy

• Get administrative support and engagement

Id tif k d i i t ti d di l di t l d• Identify key administrative and medical director leaders

• Create a guidance council from the above leaders

• Use these leaders to get support from laboratory staff and staff pathologists

• Evaluate component laboratories with defined criteria


Cost Benefit Analysis; SWOT AnalysisCost Benefit Analysis; SWOT Analysis

• Strengths - Internal Factors; What you do best?

• Weaknesses-Internal Factors; What you need to improve?

• Opportunities-External Factors ; Where is your potential for growth or expansion?p

• Threats-External Factors; What is preventing your success?

• Compare Total Costs to Total BenefitsCompare Total Costs to Total Benefits

• Total Costs > Total Benefits then Integration may not be the best option now.

• Total Costs = Total Benefits then reevaluate costs and benefits; integrationTotal Costs Total Benefits then reevaluate costs and benefits; integration may be a viable option.

• Total Costs < Total Benefits then Integration is a viable option.


Evaluate Component Laboratory-CriteriaEvaluate Component Laboratory Criteria

• Geographyg p yo Distance from other laboratories and identified main

laboratoryo Cost of travel and frequency of tripso Travel constraints

• Pathology groupso Number of pathologistso Existing specialtieso Structure and relationship to laboratory



• Instrumentationo Test menuso Platforms (variable instrument size to support different

laboratory configurations and footprint)o Laboratory layout and floor spaceo QC program and materialso Service contracts and warranty

M i t d d tio Maintenance and downtime



• Staffinggo Current levelso Training and competencyo Skillso Overtime, supervision and turnovero Union versus non-union staff

• Administrative structure and resourceso Budgeto Management layers and Organization chart



• Information systemsyo Flexibility and customizationo Interfaces and technical supporto Security and HIPAA complianceo Meets needs of lab and integration process

• QA resourceso Document controlo QA staff and programo Regulatory compliance



• Non-Laboratory Issuesyo Level of laboratory support from administration,

medical staff and nursingo Key stakeholderso Laboratory and hospital culture and moraleo Communicationso Acceptability of change

L l t d ti io Legal costs and contingencies


How to Integrate-Follow the Tracks of Other Integrated Laboratory SystemsIntegrated Laboratory Systems


How to Integrate-Next Steps (Gap Analysis)How to Integrate Next Steps (Gap Analysis)

• Create a matrix of component laboratory characteristicsp y

• Analyze the matrix for strengths, weaknesses and common features

• Identify the characteristics of a fully integrated component laboratory in the systemp y y

• Compare the component laboratories to the ideal fully integrated component laboratory

• Determine the changes each component laboratory would have to make


How to Integrate-Ideal Component LaboratoryHow to Integrate Ideal Component Laboratory

• Courier systemy

• Instrumentation-test menu, platforms, QC program

St ffi b d t f t ff• Staffing-number and type of staff

• Information systems-operation needs and interfaces

• Pathology group-number and specialty

• QA-standard SOP, document control, regulatoryQA standard SOP, document control, regulatory compliance

• Management structure


a age e t st uctu e

How to Integrate-Additional Steps #1How to Integrate Additional Steps #1

• Determine timeline for integration and resource grequirements

• Create technical teams of laboratory staff and ypathologists to support implementation

• Define reasonable and clear change control plang p

• Obtain administrative and medical director support

Allocate financial support for plan implementation• Allocate financial support for plan implementation


How to Integrate-Additional Steps #2How to Integrate Additional Steps #2

• Determine measurable benchmarks during the gimplementation

• Use laboratory guidance council and technical teamsy g

• Actively communicate with administration, pathologists and lab staff

• Consider changes to the implementation plan as needed

Encourage a system laboratory culture instead of• Encourage a system laboratory culture instead of individual laboratory culture


After Integration and BeyondAfter Integration and Beyond

• Continue to encourage a system laboratory cultureg y y

• Provide ways for lab staff to interact between individual laboratories

• Measure revenues and costs

C ti ti it f id il d t h i l• Continue activity of guidance council and technical teams

Periodic inter laboratory audits and reviews• Periodic inter-laboratory audits and reviews

• Seek system inspection status from CAP and other agencies


agencies

SummarySummary

Laboratory integration can provide significant benefits y g p gincluding cost reduction to laboratories, hospital systems and patients in the current medical care environment

There are many obstacles to laboratory integration which can be overcome with good communication and clearly defined project plandefined project plan

Laboratory integration requires significant effort and takes years to complete but will result in a better laboratoryyears to complete but will result in a better laboratory service for patients and providers


The Journey to an Integrated Laboratory System May Resemble an Old Steam Train TripMay Resemble an Old Steam Train Trip


AcknowledgementAcknowledgement

• Deb Zern-QA Manager Intermountain Healthcare Central Q gLaboratory

• Jean Ball-CAP Staff Inspection Team Leadp

• Bessie Motley-CAP Staff Inspection Specialist

C l B CAP St ff I ti S i li t• Carol Bruggeman-CAP Staff Inspection Specialist


Thank you!Thank you!

• Thank you to our presentero Dr. Paul Urie

• Thank you to our panel memberso Jean Ballo Bessie Motleyo Carol Bruggemano Joan Roseo Carolyn Gandy

• Thank you to our participants for their time.


QuestionsQuestions

Questions?


integrating laboratories–why, when, and how: the good, the

Documents