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Parallel Testing and Implementing New QC Material

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143 views14 pages

Parallel Testing and Implementing New QC Material

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salamon2t
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© © All Rights Reserved
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SMARTLABTOOLS™

QUALITY CONTROL
SYSTEM
Parallel Testing and Implementing a New Lot
of QC Materials
Templates: SLT_413, SLT_417 SLT_400

Daniel W. Leighton, MS,MT(ASCP),HCLD(ABB),CLB


dan@smartlabtools.com

Ver.010817
2

Objective: Parallel Testing New QC Lot(s)


• SLT Templates are used to facilitate the calculations
necessary to establish QC limits for a new lot of controls.

• The examples shown are for QC of the ACCESS-II


immunochemistry analyzer using BioRad Controls.

• Note: CLIA regulations require that the laboratory


establish it’s own mean and standard deviation through
repetitive testing. 493.1218 (5d)
3

CLSI C24-A3, 8.6.2. Provides the following guidance if


Assayed Control Materials are used:
• The values stated on the assay sheets provided by
manufacturer should be used only as guides in setting the
initial control limits for testing new control materials.

• Actual values for the mean and standard deviation must


be established by serial testing in the laboratory.

• The observed mean should fall within the range published


by the manufacturer.

• EQA and peer-comparison provide useful measures of the


means and SDs observed in other laboratories.
4

Step-1
Run New Set of
Controls x 10
(as unknowns)
For cross-over between
two different lots of
control materials, lab may
calculate the mean for
the new material from the
first 10 measurements,
and use the CV from the
previous lot of QC
material to calculate the
SD, then used to
calculate QC limits.

New control materials


should be run in parallel
with existing controls ,
tested as unknowns over
multiple days/runs
1 of 10 Measurement Replicates
5

Step 2.
Use SLT 413 Templates to Analyze Data (Level-1 QC Shown)

Means from Insert Used for Note E2 %Recovery is


“Target” Values High, but within “Insert” Limits
6

Step 2. (cont.)
Use SLT 413 Templates to Analyze Data (Level-3 QC Shown)
7

Step 3.
Compare
Preliminary Lab
Values vs. Insert ..
Mean & Range are
used on the
SLT_413 Form
Means from parallel
study should fall within
the manufacturer’s
stated range.

Insert limits should be


used only as guides in
setting initial control
limits for testing new
control materials.

Convert Insert 3SD


limits to 2SD for better
comparison (next slide)
8

Step 3. (cont.)
Convert Insert
stated 3SD limits
to 2SD limits
SLT_105 and SLT_400
Daily QC Assessment
Template setup requires
user input of 2SD limits
for each analyte. SLT_414.5 Use when SD is not given

Templates are available


that simplify conversion
calculations.
SLT_414, SLT_414.5

Until lab has run


sufficient QC data for
establishing solid 2SD
QC limits, then use of
“insert”, “peer”, or “HCV”
derived 2SD limits are SLT_414 Use when Mean and SD are given
interim options.
9

Step 4. Compare with Manufacturer’s Peer Report

The lab will use the calculated mean, along with the peer CV to
calculate it’s interim QC limits for the new QC materials.

We note that the peer Level-1 E2 value more closely matches the
E2 value from the lab study (50.8). The most current peer reports
contain the more reliable comparative values.
10

Step 5. Using Template SLT 417 to Calculate 2SD Limits


Lab determined
Means, and Peer
CV’s (Historical CV’s)
are used here to
calculate interim
2SD Limits.

Optionally, Lab
Previous Lot
SD’s or CV’s are
used with the
new QC means

QC Limits are
best determined
by cumulative
statistics from 3-6
months testing.
SLT_417 Used Here - Lab Mean & Peer CV
11

Step 6. Enter 2SD Limits into QC Assessment Template


When using the
SLT Daily QC
Assessment
Template (SLT_400),
2SD Limits are
Entered on the 2nd
page of the 2-page
Template.
12

Step 7. Daily QC Statistical Assessment (SLT_400)


QC Form
(page-1) is
now ready to
test data
from Study
to rule out
typo’s.

Verified QC
Limits are
set into
Analyzer &
LIS QC
programs.
13

Step 8. Inform Analysts Of Lot Change


• Post Clear Messages as to which QC Materials, QC Files, QC
Templates are to be used once change is made.

• AVOID mix-ups such as using old material with new QC Files /


Templates.. or… new QC material with old QC Files /
Templates.

• BEST REMOVE OLD QC MATERIALS to avoid such incidents


& resultant headaches.

• Closely monitor QC activities for first few days new QC


materials are in use.

• Make on-going statistical parameter adjustments if warranted.


14

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