Documenti di Didattica
Documenti di Professioni
Documenti di Cultura
Surveyors
Calibration and
Calibration Verification
Pam Gottsponer
Ed Sass
Calibration
Calibration Verification
Verification of Performance
Specifications
Calibration Verification
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6/16/2011
Exceptions
Calibration
Microscopic Procedures
(KOH,
WBC differential, urine sediment, etc.)
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Calibration Summary
Definition: sets the instrument to
provide accurate results
Calibration Procedure
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Calibration Verification
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16
6/16/2011
Calibration Verification
Change in reagents;
Major preventive maintenance;
Controls are not acceptable
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Exception:
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Exception: Impedance
Hematology Cell Counters
Calibration Procedure
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Exception: Impedance
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Reportable range or
Clinically significant range;
Not reference range
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6/16/2011
Specimens
Acceptable limits
already established?
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Control Materials or
Calibration Materials
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Calibration and
Calibration Verification
Failed Calibration or
Calibration Verification
Every analyte;
Every instrument even multiples
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28
6/16/2011
Failed Calibration
Verification
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Review
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Review
34
6/16/2011
Review
Review
Exceptions include:
Manual procedures
Microscopic procedures
Review
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Review
Review
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Review
Calibration Verification procedure:
Test three levels (low, mid-point, high)
Test like patient samples
Compare results to the acceptable limits
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6/16/2011
Review
Review
Document:
Procedure date and initials
Calibration materials lot number,
expiration date and package insert
Results acceptable, review, sign
Root cause investigation
Corrective actions taken
Resources
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Resources
COLAcentral:
www.COLAcentral.com
COLA Website:
www.COLA.org
Louise Jackman
Irwin Rothenberg
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Resources
Resources
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46
6/16/2011
Resources
Resources
LabFacts menu
http://www.cola.org/resources.html?PDFCategoryID=6
LabFacts 20 32
These are for specific specialties, subspecialties or
tests. They contain Quality Control information and
general information about the individual topic.
Access them at the menu website listed above
and click on the desired LabFacts sheet.
Immunohematology
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Resources
Resources
http://www.cola.org/product.html?ProductID=339
This course addresses the quality control (QC) requirements for
non-waived laboratory testing, as stipulated by the CLIA 88
regulations. QC is an integral part of the total testing process
and is an essential element for producing accurate test results
in the clinical laboratory.
The lessons include everything from tips for selecting control
materials to quality assessment of QC.
http://www.cola.org/product.html?ProductID=202
This course explains the process of calibration verification as
detailed in the CLIA regulations.
It is presented by Audit MicroControlsTM and introduces
products manufactured by Audit that can be used as
calibration verification materials.
A glossary and links to additional resources are also
included.
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Resources
Online Course:
COLAcentral:
www.COLAcentral.com
Website:
www.COLA.org
Email:
info@COLA.org
Address:
8009819883
LabUniversity: www.labuniversity.org
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