6/16/2011

Surveyors

Calibration and
Calibration Verification

Pam Gottsponer

Ed Sass

Terri Scott, MT(ASCP)

Education Division Medical Technologist

Leigh Ann Smith

6
5

Calibration

Calibration Verification

Sets the instrument to give an

accurate result for each analyte

Ensures that calibration is

still providing accurate results
throughout the reportable range

Verification of Performance
Specifications

Calibration Verification

Verify the manufacturers stated

specifications prior to patient testing

According to manufacturer instructions;

At least every six months

COLA criteria: CA2

10

6/16/2011

Exceptions

Manual Procedures (cultures,

susceptibility tests, tube tests, etc.)

Calibration

Microscopic Procedures

(KOH,
WBC differential, urine sediment, etc.)

According to manufacturer instructions

or laboratory protocol; Six months;
When Calibration Verification fails

Prothrombin Time Devices

POCT Devices
Must do Calibration Verification
11

COLA criteria: CA1

12

Calibration Summary
Definition: sets the instrument to
provide accurate results

Calibration Procedure

Manufacturer states number, type and

concentration of materials
Refer to manufacturer instructions;
Use calibration materials (standards);
Type, number and concentration vary

COLA criteria: CA1

Frequency manufacturer instructions,

or lab policy, at least every 6 months
Performed when Calibration
Verification is not acceptable
13

14

Calibration Verification

According to manufacturer instructions;

More often, if determined by lab;
At least every six months;

15

COLA criteria: CA2

16

6/16/2011

Exception: Calibration not

Calibration Verification

affected by reagent change

Change in reagents;
Major preventive maintenance;
Controls are not acceptable

COLA criteria: CA5 & CA6

Document several consecutive

instances where no calibration
adjustments were needed

17

Exception:

COLA criteria: CA2

18

Exception: Impedance
Hematology Cell Counters

Calibration Procedure

Follow manufacturers instructions;

Calibrate every 6 months;
Obtain acceptable results for at least 2
levels of controls for each day of testing

Use at least three levels of calibration

materials: low, mid-point, high;
Performed every six months.

COLA criteria: CA2

19

Exception: Impedance

20

Low, mid-point, high levels

Hematology Cell Counters

QBC centrifugal hematology systems:

NOT impedance, Calibration Verification
MUST be performed

COLA criteria: CA2

COLA criteria: CA2

Reportable range or
Clinically significant range;
Not reference range

21

22

6/16/2011

Specimens

Acceptable limits
already established?

Commercially prepared calibration

materials, proficiency samples, controls;
Previously tested patient samples

Commercially prepared samples: Yes

Previously tested patient samples: No

23

24

Calibration Verification Procedure

Control Materials or
Calibration Materials

Test at least three levels: low,

mid-point and high
Test them in the same manner as
patient samples

The Calibration lot number must be

different than what you use for
daily QC or current calibration

Compare results to acceptable limits

Failure: one or more values outside
acceptable limits
25

26

Calibration and
Calibration Verification

Failed Calibration or
Calibration Verification

Every analyte;
Every instrument even multiples

Determine root cause;

Take corrective action;
Repeat verification

27

COLA criteria: CA7

28

6/16/2011

Documentation: retain for two years

Failed Calibration
Verification

Procedure date and initials

Verification materials lot number,
expiration date and package insert

Check with manufacturer if Calibration

Verification fails on instruments that do
not allow user performed Calibration

Results Acceptable? Reviewed?

Investigation and corrective action
steps
COLA criteria: CA9

29

30

Written Policy and Procedure

Statement that Calibration Verification
is performed at least every six months
Detailed performance instructions
Analytes to be tested
Verification materials to use
Evaluate and review
Corrective actions
Documentation
Retention time
COLA criteria: CA9

31

Review

32

Review

Calibration: Sets each instrument to give an

accurate result for each analyte
Calibration Verification: Ensures that the
instruments calibration is still valid to allow
accurate results throughout the reportable
range
Verification of Performance Specifications
Webinar 8, April 2011
33

Calibration is performed at the frequency

established by the manufacturer, or your
laboratory if needed more frequently, but
must be done at least every six months.
Also done if Calibration Verification fails.
Calibration Verification is performed at the
frequency established by the manufacturer,
but must be done at least every six months.

34

6/16/2011

Review

Review

Exceptions include:

Calibration materials, also known as

standards or calibrators, contain a known
amount of the analytes to be tested.

Manual procedures
Microscopic procedures

Perform calibration according to the

manufacturers instructions
Number
Type
Concentration

Prothrombin Time devices

Instruments calibrated by the factory
that do not allow user calibration
Calibration Verification must be
performed
35

Review

36

Review

Calibration Verification must be performed

If there is a change in reagent lot
number, formulation or manufacturer
If major preventive maintenance has
been done
If critical parts have been replaced

Calibration Verification requirements are

satisfied under specific circumstances:
Three level calibration performed every
six months
Documented that calibration is not
affected when reagent lot changes
Hematology cell counters that utilize the
impedance principle

Can also be used to troubleshoot

unacceptable QC results
37

Review

38

Review
Calibration Verification procedure:
Test three levels (low, mid-point, high)
Test like patient samples
Compare results to the acceptable limits

Materials used to perform Calibration

Verification:
Commercially prepared calibration
materials
Previously tested Proficiency Testing
samples
Control materials (different lot number)
Previously tested patient samples

Calibration Verification fails if one or more of

the results do not fall within the acceptable
limits.
Investigate root cause and take corrective
actions.
39

40

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

Written Policy and Procedure

When and how often to perform
Instructions for performance
Analytes to be tested
Verification materials to use
How to review and evaluate
Corrective actions
Documentation

Retain for at least two years

41

Resources

42

Resources

COLAcentral:

www.COLAcentral.com

COLA Website:

www.COLA.org

Westgard QC website: http://www.westgard.com/

CMS, CLIA website: http://www.cms.hhs.gov/clia

COLA Technical Consultants:

CDC, CLIA website (for hyperlinked regulations):

http://wwwn.cdc.gov/clia/regs/toc.aspx

Louise Jackman
Irwin Rothenberg

CLIA Quality Control regulations

(Subpart K, 493.1200 493.1299):
http://wwwn.cdc.gov/clia/regs/subpart_k.aspx

LabFacts 50 Quality Control Primer

http://www.cola.org/storage/elf50.pdf

43

44

Resources

Resources

CLIA Facts menu:

http://www.cola.org/resources.html?PDFCategoryID=2

CLIA Facts 16A Quality Systems: Analytic Phase

CLIA Facts 2 Test Method Verification

CLIA Facts 16B Quality Systems: Analytic Phase

Procedure Manual and Test Systems

Performance Specifications and Calibration

CLIA Facts 11 Waived Testing

CLIA Facts 16C Quality Systems: Analytic Phase

CLIA Facts 14 Quality Systems:

General Laboratory Practices

Maintenance and Function Checks and Test Records

CLIA Facts 16D Quality Systems: Analytic Phase

Comparison of Test Results and Corrective Actions

45

46

6/16/2011

Resources

Resources

CLIA Facts 16E Quality Systems:

LabFacts menu
http://www.cola.org/resources.html?PDFCategoryID=6

Analytic Phase Control Procedures

CLIA Facts 18 Control Procedures for Chemistry
CLIA Facts 19 Control Procedures for Hematology
CLIA Facts 20 Control Procedures for Microbiology
CLIA Facts 21 Control Procedures for

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

47

48

Resources

Resources

Online Course: Quality Control for the Laboratory

Online Course: Calibration Verification

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.

A glossary and links to additional resources are also included.

49

50

Resources

COLA Contact Information

Online Course:

COLAcentral:

www.COLAcentral.com

Website:

www.COLA.org

This course will assist laboratories in understanding and

meeting the requirements for verification of performance
specifications. It defines performance specifications, and
explains the associated CLIA requirements and their purposes.

Email:

info@COLA.org

Address:

9881 Broken Land Parkway, Suite 200

Columbia, MD 21046-1195

Appropriate sample selection is discussed and suggested

procedures are provided with example data to demonstrate the
process.

Information Resource Center:

Verification of Performance Specifications

http://www.cola.org/product.html?ProductID=371

8009819883

LabUniversity: www.labuniversity.org

A glossary, printable worksheets, and links to additional

resources are also included.
51

52