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

4

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.