Raising the Bar on Lab Quality: Understanding the Lab Test Life Cycle, Its Role in Your Lab's Recurring Cost of Bad Quality, and Proven Steps to Boost Quality while Reducing Cost
Lucia M. Berte Laboratories Made Better! P.C. Broomfield, Colorado, USA
At the end of this presentation you will be able to: Describe the sequence of activities in the laboratory
test life cycle and identify which laboratory type performs which parts
Provide examples of the 4 types of quality costs
Apply a quality cost type to each part of the test life cycle
Access resources to learn more about LDTs and the Cost of Quality
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Establishment
Implementation
Laboratory Test Life Cycle
3
“Manufacturer”
Developing company… or laboratory
(ie, LDT)
“User”
Implementing laboratory
Expanded Test Life Cycle
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Establishment
Implementation
1
2
3
1. Feasibility and Design (Developer)
Literature review
Clinical usefulness / intended use
Feasibility assessment
Legal right to use
Marketing assessment 5
Establishment
2. Development Sample
Instrumentation
Reagents
Calibrators
Controls
Process and procedure (SOP)
Validation criteria
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Sample Sample
processing Instrument
set-up Test Evaluate results
Establishment
3. Validation – A Documented Plan
Validation plan ◦ Purpose ◦ Description ◦ Responsibilities ◦ References ◦ Acceptance criteria ◦ Qualifications Installation Operational *Performance
◦ Conclusion
Specifications ◦ Detection capability ◦ Analytical specificity ◦ Trueness (Accuracy) ◦ Precision ◦ Measuring interval ◦ Reference interval ◦ Reagent and sample
stability ◦ Clinical validation
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Establishment* of method performance specifications
Establishment
Expanded Test Life Cycle
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Establishment
Implementation
1
2
3
4
5
5. Retirement
2. Verification
3. Implementation
4. Maintenance
in the Medical Laboratory
1. Preliminary evaluation
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1. Preliminary evaluation
Clinical needs and expectations of laboratory customers
All needed elements are in place ◦ Instrument(s) ◦ Reagents, calibrators, controls ◦ Disposable materials ◦ Software, interfaces ◦ Personnel
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Implementation
2. Verification
Verification plan ◦ Purpose ◦ Description ◦ Responsibilities ◦ Acceptance criteria ◦ Qualifications Installation Operational *Performance
◦ Conclusion
Verify the developer’s specifications ◦ Precision ◦ Trueness (accuracy) ◦ Detection capability ◦ Measuring interval ◦ Reference interval
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Assurance* that performance specifications can be met
Implementation
Precision Accuracy Measuring interval Reference interval Detection capability Analytical specificity Clinical validation Reagent and sample
stability
Precision Accuracy Measuring interval Reference interval Detection capability
Developer vs User
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3. Implementation for Use Documented processes
and instructions for: ◦ Sample collection, handling,
transport ◦ Sample accessioning and
any pre-test processing ◦ Instrument set-up and run ◦ Review, record, and follow-
up results ◦ Prepare and release
reports ◦ Sample archiving ◦ Records archiving
Procurement of materials
Equipment management plan
Information system integration, as needed
Proficiency testing enrollment
Communication to customers
Training and competence assessment
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Implementation
4. Maintenance – of the method
Calibrations and verifications performed per schedule
Instrument maintenance followed per schedule
IQCP followed for each analyte Acceptable PT performance Documented change control plan and
change records, including reverification
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Implementation
5. Retirement – of the method
Notify customers Archive process and
procedure documents Archive testing and
results records Remove related
reagents and supplies from inventory
Decontaminate equipment for disposition
Gather all equipment records
Close the equipment master file
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Implementation
Critical Distinction for LDTs
Are considered manufacturers Must follow design and
development requirements ◦ Need to create the design history
file and records
◦ Need to create design change records
Must validate the method before use ◦ Need to establish performance
specifications
◦ Need to create the validation records
Must verify the performance specifications established in the LDT before use ◦ Need to create the verification
records
Must create the QC Plan Must perform PT, if only an
alternative means Must go back and validate any
method changes
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Labs that develop tests: Labs that use LDTs:
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Types of Quality Costs
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Types of Laboratory Quality Costs
• Ongoing competence assessment
• Performing, reviewing QC Participating in PT
• Measuring quality indicators
• Conducting internal audits • Participating in external
laboratory accreditation inspections and assessments
• Quality planning • Work process training • Initial competence
assessment • Supplier capability • Preventive maintenance • Process validation and
verification • Lean improvement
projects
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ATTENTION !!
These costs support good quality!
Educate and justify to retain these costs. Reductions here will lead to problems.
Recurring Cost of “Bad” Quality
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Failure Costs – Internal (Before Delivery of Results)
Sample problems in the preexamination phase
Insufficient or expired reagents or supplies
Rework, repair, retesting, reinspection
Wasted blood and blood components
Downtime ◦ Computer ◦ General unavailability
of services Any NCE caught
and corrected before customer receipt
Failure Costs - External (After Customer Receipt)
Lost reports Lost samples
after testing Reporting errors Customer
complaints
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Other NCEs, post receipt
Misdiagnoses Lawsuits
Understanding Failure Cost Elements
Laboratory budgets do not have a “Failure Costs” category—
the expense is added to the current operational performance.
Common Activities
Done Correctly, the First Time
Additional Work Due to Process Failure
Possible Additional Work for the Failure
Discovery of failure (NCE) X Immediate action X
Preexamination X Depends on failure Examination X Depends on failure Postexamination X Depends on failure
Investigation X Root cause analysis X Corrective action X Report completion X X
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Talk About Failure Cost!!
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“Because of a lab chemist’s widespread criminal misconduct in analyzing drug samples, about 90% of 20,000 drug convictions in Massachusetts have been dismissed…”
“…intentionally contaminating some samples to turn from negative to positive, falsifying results, and mishandling evidence…”
“The furthest thing from her mind is that this is going to cost millions of dollars…”
Tuesday, April 18, 2017
Establishment, Quality Costs, and LDTs
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Establishment Costs
5. Retirement
2. Verification
3. Implementation
4. Maintenance
Implementation, Quality Costs, and LDTs
1. Preliminary evaluation
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This report uses the “measurement procedure life cycle” framework to aid users of CLSI EP documents during the establishment and implementation of measurement procedures developed by both commercial manufacturers and clinical laboratories, ie, for laboratory developed tests.
Quality System Regulation for
LDTs
A Practical Guide for the Laboratory
2015
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Resources: Non-Laboratory COQ Schiffauerova A, Thompson T.
A review of research on cost of quality models and best practices. International Journal of Quality and Reliability Management, Vol.23, No.4, 647-669, 2006.
Wood DC, mng ed. Principles of Quality Costs, 4th ed. Milw, WI: ASQ Quality Press, 2013.
Wood DC. The Executive Guide to Understanding and Implementing Quality Cost Programs. Milw, WI: ASQ Quality Press, 2007.
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This report provides guidance to a laboratory in understanding and managing the different types of quality costs that affect processes, services, and financial well-being. 2014
A Fact About the Recurring Cost of “Bad” Quality
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Schiffauerova A, Thompson T. A review of research on cost of quality models and best practices. International Journal of Quality and Reliability Management, Vol.23, No.4, 2006.
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