Workbook - bioMérieux University

Chapter 3:
CLIA Regulations and Procedures
For miniVIDAS® Users
OBJECTIVES
Upon completion of this chapter, you will be able to:
• Determine steps that must be completed before using the
miniVIDAS to test patients
• Indentify CLIA procedures and requirements
• Discuss the purpose of QA activities (before, during, after)
• Describe Method Validation
• Explain the various Bulls Eye target results found in Method
Validation
PRINTING & VIEWING INSTRUCTIONS
Print (preferably in color) and read the objectives and questions for
each chapter prior to viewing the associated video. Questions may be
answered as you view the video. For specific instructions on video
viewing, please refer to the Getting Started link.
GUIDED VIEWING QUESTIONS
Clinical Laboratory Improvements (CLIA) Regulations have been in
effect since 1992 and thousands of laboratories across the nation
comply with these requirements. Laboratories must be CLIA
accredited and participate in proficiency testing before using the
bioMérieux miniVIDAS.
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Read the statements below and put each action in sequential order,
number one being the first step and four the last step.
1. There are certain steps that must be performed before you can
begin testing patient samples. Place the following steps in
sequential order.
_____ Annually enroll in any CLIA approved proficiency testing
program and test ‘unknown’ PT samples mailing the results
back to the PT program.
_____ Read the CLIA Compliance Manual.
_____ Method validation is required by CLIA to verify that the
miniVIDAS® meets the manufacturer’s claims for accuracy,
precision and linearity in your laboratory. The method
validation process must be performed over two days and is
explained in the CLIA Compliance Manual.
_____ Contact your state Centers for Medicare and Medicaid
Services (CMS) to enroll in the CLIA program or to upgrade
your current CLIA certificate for immunoassay testing on the
miniVIDAS.
Determine whether each statement is correct or incorrect by circling
either “True” or “False”.
2. Fees for CLIA certification are assessed annually.
True
False
3. In order to perform immunoassay testing on the miniVIDAS, it may be
necessary to upgrade a current CLIA certificate.
True
False
4. It can take up to 12 weeks to receive a new CLIA identification number.
True
False
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5. When billing Medicare for tests run on the miniVIDAS®, CLIA ID
numbers must be put on Medicare claim forms as failure to do so
results in denied claims that cannot be resubmitted.
True
False
6. For Method Validation, quality control samples are run several
times to demonstrate that the instrument is accurate and precise
and meets manufacturers claims for accuracy, precision and
linearity in a lab.
True
False
7. To demonstrate the laboratory’s compliance with CLIA
requirements, use the policies, procedures and completed forms
in the CLIA Compliance Manual.
True
False
8. CLIA inspections are punitive in nature.
True
False
9. To test your understanding of safety precautions found in the CLIA
Manual, review and place a check mark ‘√’ next to those that apply.
____
____
Disinfect countertops in the testing area at least once a day.
Clean spills immediately.
Discard blood specimens, used SPR®s and strips into a
biohazardous waste container.
____
Do not store food in the refrigerator where reagents, controls,
or specimens are kept.
____
Use SPR to puncture foil on reagent strip.
____
Splashes can occur when stoppers are removed from blood
tubes and areas must be wiped clean upon completion of task.
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CLIA quality requirements or quality assessments (QA) are activities
performed to minimize testing errors before, during and after patient
testing.
10. Read each QA activity in the table below and determine whether
the activity occurs before, during or after testing by placing an ‘X’
in the appropriate column.
QA Activity
Before
During After
Check instrument each day of
testing with quality control
samples to insure it functions
properly
Review results, store instrument
printouts, and report them to the
caregiver
Obtain test requests in writing
Follow written test procedures
Label blood tubes so that mix-ups
do not occur
Handle and process specimens so
that test results are not affected
Perform ongoing quality
assessments to be sure you have
the best systems in place to
prevent errors
Check reagents to insure they are
not outdated or deteriorated
Collect the right specimen from
the right patient
Periodically calibrate the
instrument to set its electrical
system
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Read the statements below and circle the correct letter for each
answer.
11. During a CLIA inspection, a surveyor will ask to see evidence that
the lab has performed proficiency testing, quality control and ____.
A. quality assurance
B. quality assessment
C. quality inventory
D. quality inspection
Method Validation verifies accuracy, precision, reportable ranges and
reference ranges.
12. _____ tells how closely your instrument measures the ‘true’ value
of an analyte and is verified by running three levels of controls
several times.
A. Accuracy
B. Precision
C. Reference Range
D. Reportable Range
13. _____ defines how reproducible your results are over time, and is
verified by running three levels of controls several times over two
days.
A. Accuracy
B. Reference Range
C. Precision
D. Reportable Range
14. A Bullseye target can illustrate __________ and __________.
A. normal ranges and abnormal ranges
B. accuracy and precision
C. accuracy and reportable ranges
D. quality assessment and accuracy
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15. _____ are specified by accepting the manufacturer’s suggestions
or by stipulating your laboratory’s ranges.
A. Outlying ranges
B. Reference/Normal ranges
C. Obsolete ranges
D. Reportable ranges
16. Who specifies acceptance parameters for accuracy, precision or
reportable ranges?
A. Lab director
B. CLIA personnel
C. Lab technician
D. Surveyor
17. Below are quality control test results that have been plotted on a
target. Determine accuracy and precision of each target by
drawing a line matching each target with the accurate value
description.
Imprecise, Inaccurate
Very Accurate, Precise
Precise, Inaccurate
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