integrating multi-site laboratories: what the ...€¦ · medical director, pathology and...

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

© 2012 College of American Pathologists. All rights reserved. 2

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


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


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


Why are the LAP Checklists and Director Responsibilities Important?

6 © 2014 College of American Pathologists. All rights reserved.

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


•  Individual laboratories •  Hospital system •  Pathologists •  Patients

Why Integrate? Advantages to Laboratories




•  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



•  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



•  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? Accountable Care Organizations


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)

When to Integrate-Possible Obstacles


•  Lab management of individual labs •  Laboratory director and staff pathologists •  Medical staff and nursing •  Hospital administration •  Corporate administration

When to Integrate-Possible Obstacles


•  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

When to Integrate-How to Overcome Obstacles


•  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


•  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


•  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



•  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



•  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


•  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



•  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

How to Integrate-Next Steps (Gap Analysis)


•  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


•  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


•  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


•  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


•  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

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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© 2013 College of American Pathologists. All rights reserved.

Urquhart Castle-Loch Ness Scotland


Laboratory Integration: Much Easier Than Finding the Loch Ness Monster

integrating multi-site laboratories: what the ...€¦ · medical director, pathology and...

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