Paul M Urie MD PhD Medical Director, Pathology and Laboratory Clinical Service
Intermountain Healthcare April 26-27, 2016
Integrating Multi-Site Laboratories: What the Accreditation Process Teaches in Best
Practices
Intermountain Healthcare Intermountain Medical Center Murray, UT
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Specific Checklist Questions Part 1
TLC.10430 Phase II Director Responsibility/Authority The laboratory director has sufficient responsibility and authority to implement and maintain the standards of the College of American Pathologists TLC.10440 Phase II Effective QM Written QM plan covering all areas of the laboratory Records documenting the laboratory director approval of the QM plan and the selection of quality indicators Records documenting laboratory director review of quality indicators, annual assessment of QM plan, complaints, and incidents with development and implementation of plans of corrective action
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Specific Checklist Questions Part 2
TLC.11300 Phase II Director Responsibility – Personnel The laboratory director ensures sufficient personnel with adequate documented training and experience to meet the needs of the laboratory TLC.11475 Phase I Director Responsibility - Equipment Selection The laboratory director or designee is directly involved in the selection of all laboratory equipment and supplies with respect to quality
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The Quality Management Plan
• CAP and CLIA accreditation requirement • Information and communication • Entire analytic cycle • Metrics, benchmarks and indicators • Corrective action and follow-up to
problems • Commitment to quality and patient safety • Continuous improvement
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Why are the LAP Checklists and Director Responsibilities Important?
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Many pathologists who are laboratory directors are more interested in anatomic pathology than the clinical laboratory.
Laboratory Integration can help pathologist laboratory directors meet the requirements of the LAP checklists and CLIA law.
Pathways of Laboratory Integration
• Integrated laboratories with identified centers of excellency-specialized tests are sent to the identified laboratories
• Central laboratory with regional rapid response laboratories-esoteric tests and high volume tests are sent to the central laboratory
Why Integrate? Advantages versus Status Quo
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• Individual laboratories • Hospital system • Pathologists • Patients
Why Integrate? Advantages to Laboratories
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Why Integrate? Advantages to Laboratories
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• Standardize equipment platforms • Centralize capital equipment acquisition • Centralize vendor negotiations-improves position • Centralize project oversight and funding • Centralize supply purchasing and reagent sharing • Standardize service contracts and maintenance
agreements • Lot number sequesters-sharing of QC materials
Why Integrate? Advantages to Laboratories
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• Standardize SOP’s-development, reviews and revisions • Standardize document control • Standardize training and competency • Standardize training and competency • Standardize QC program • Standard regulatory inspections for CAP and CLIA • Uniform change control procedures
Why Integrate? Advantages to Laboratories
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• Reduce variation-lower costs and error reduction • Control test menus at facilities to manage utilization • Drives testing to facilities with lowest cost per test • Uniform service performance to patients-costs • Enhance marketability of laboratory service to providers • Centralize esoteric testing • Promotes inter-laboratory cooperation
Why Integrate? Advantages to Laboratories
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Why Integrate? Accountable Care Organizations
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Accountable Care Organization accepts responsibility for the quality, cost and overall care of a defined population
The Healthcare system is fatally flawed Unwarranted variation is the biggest problem If 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)
Why Integrate? Advantages to Laboratories
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When to Integrate-Possible Obstacles
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• Lab management of individual labs • Laboratory director and staff pathologists • Medical staff and nursing • Hospital administration • Corporate administration
When to Integrate-Possible Obstacles
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• Individual laboratory history, culture and processes
• Geographic differences • Cost of travel and courier system • Different LIS and EMR systems • Laboratory staff suspicions • Lack of financial resources to support integration
Why Integrate? Advantages to Laboratories
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When to Integrate-How to Overcome Obstacles
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• Identify and promote leaders-pathologists and management
• Clearly articulate advantages of integration • Accurate financial data on current lab operations • Create a financial model for integrated lab
service based upon reasonable assumptions • Frequent communications with stake holders
How to Integrate Labs-Suggested Process
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• Perform cost assessment and benefit analysis • Get administrative support and engagement • Identify key administrative and laboratory director leaders • Create a guidance council from the above leaders • Use these leaders to get support from lab staff and staff
pathologists • Evaluate component labs with defined criteria
Evaluate Component Labs-Criteria
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• Geography • Distance from other labs and identified main lab • Cost of travel and frequency of trips • Travel constraints
• Pathology groups • Number of pathologists • Existing specialties • Structure and relationship to lab
Evaluate Component Labs-Criteria
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• Instrumentation • Test menus • Platforms (variable instrument size to support different
lab configurations and footprint) • Lab layout and floor space • QC program and materials • Service contracts and warranty • Maintenance and downtime
Evaluate Component Labs-Criteria
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• Staffing • Current levels • Training and competency • Skills • Overtime, supervision and turnover • Union versus non-union staff
• Administrative structure and resources • Budget • Management layers and Org chart
Evaluate Component Lab-Criteria
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• Information systems • Flexibility and customization • Interfaces and technical support • Security and HIPAA compliance • Meets needs of lab and integration process
• QA resources • Document control • QA staff and program • Regulatory compliance
Evaluate Component Labs-Criteria
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• Non-Lab Issues • Level of lab support from administration, medical staff
and nursing • Key stakeholders • Lab and hospital culture and morale • Communications • Acceptability of change • Legal costs and contingencies
Why Integrate? Advantages to Laboratories
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How to Integrate-Next Steps (Gap Analysis)
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• Create a matrix of component lab characteristics • Analyze the matrix for strengths, weaknesses and
common features • Identify the characteristics of a fully integrated component
lab in the system • Compare the component labs to the ideal fully integrated
component lab • Determine the changes each component lab would have
to make
How to Integrate-Ideal Component Lab
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• Courier system • Instrumentation-test menu, platforms, QC program • Staffing-number and type of staff • Information systems-operation needs and interfaces • Pathology group-number and specialty • QA-standard SOP, document control, regulatory
compliance • Management structure
How to Integrate-Additional Steps #1
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• Determine timeline for integration and resource requirements
• Create technical teams of lab staff and pathologists to support implementation
• Define reasonable and clear change control plan • Obtain administrative and medical director support • Allocate financial support for plan implementation
How to Integrate-Additional Steps #2
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• Determine measurable benchmarks during the implementation
• Use Lab guidance council and technical teams • Actively communicate with administration, pathologists
and lab staff • Consider changes to the implementation plan as needed • Encourage a system laboratory culture instead of
individual lab culture
After Integration and Beyond
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• Continue to encourage a system laboratory culture • Provide ways for lab staff to interact between individual
labs • Measure revenues and costs • Continue activity of guidance council and technical
teams • Periodic inter-laboratory audits and reviews • Seek system inspection status from CAP and other
agencies
Why Integrate? Advantages to Laboratories
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Intermountain Healthcare System Laboratory Service
2011 2012 2013 2014 2015
System Laboratory Service Staffing
Intermountain Healthcare Metrics
• CPT increases 2014 hematology analyzers, 2015 chemistry analyzers
• FTE increase 2015 precision genomics lab
Summary
Laboratory integration can provide significant benefits including cost reduction to laboratories, hospital systems and patients in the current medical care environment There are many obstacles to laboratory integration but can be overcome with good communication and clearly defined project plan Laboratory integration requires significant effort, takes years to complete but will result in a better laboratory service for patients and providers
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Urquhart Castle-Loch Ness Scotland
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Laboratory Integration: Much Easier Than Finding the Loch Ness Monster
Thank you!
Questions?
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