Individualized Quality Control
Plan Summary
Complete a separate form for each IQCP in use and present to the inspector during the on-site inspection.
Laboratory Great Plains Health
Name:
1) Instrument/Device
2) Tests
Include name,
manufacturer, and model
List all tests included
under the IQCP
hCG Combo Rapid Test,
Cardinal Health
Serum Pregnancy
Laboratory
Section/Department:
CAP
Number:
Immunology
3) Number
of Devices
In Use
4) List of Test Sites*
1
Not Applicable
If used in more than one
area
Date of
Director
Approval
9/1/12015
Date
Implemented
Click here to
enter a date.
1987701
Date
Retired
Click here to
enter a date.
5) Process Used to Monitor Risk
List control processes put in place based on risk assessment – define the monitor and frequency evaluated.
Reagents
Perform external QC
on each new lot to
verify kit performance
Environment
Perform external QC
on each new shipment
to verify kit
performance
1. Temperatures in
Laboratory recorded
daily.
2. Monthly
performance of
external QC to monitor
transient temperature
fluctuations.
Specimen
Staff verify proper
specimen type when
collected using labels
from LIS listing tube
type.
Test System
Testing Personnel
Other
Emphasized in training Staff must complete
the invalid result must procedure training
be repeated
checklist and checklist
signed by tech and
supervisor before they
can perform testing
1. Failure of Internal
Pre-Analytic
QC should return
Verification Process of
invalid result.
patient ID
2. Drops and dropper
orientation emphasized
in training
* Test sites with different CLIA and CAP numbers must complete separate forms.
NOTE: The form is intended to be used as an inspector tool and does not meet the checklist requirements for documenting the IQCP risk assessment.
IQCPS 1.0
Reagents
Environment
Specimen
Test System
Testing Personnel
Other
Cartridge identification
and test timing
emphasized in training
Review the results with
worksheet review;
done daily with
worksheet review
1. Annual review of
procedure
2. Yearly competency
checklist signed by
tech and supervisor
* Test sites with different CLIA and CAP numbers must complete separate forms.
NOTE: The form is intended to be used as an inspector tool and does not meet the checklist requirements for documenting the IQCP risk assessment.
IQCPS 1.0