Quality Control

Barbara Weberman MT(ASCP)

Oakland County Health
Division
Laboratory Supervisor

Clinical Laboratory
Improvement Act of 1988 (CLIA
88)
Set Minimum Standards for Quality Control
(QC)
Placed tests into complexity categories
High complexity
Moderate complexity
Waived
The Rapid HIV tests are considered waived

Quality Control

Process that tracks the ability of

reagents, instrumentation, and
personnel to obtain an accurate result
How many controls
How often
Minimum requirements for waived tests
are the manufacturers
recommendations in the package insert

How many, how often?

There should be at
least one control
per reportable
result
Reportable results
include positive
and negative
results

Follow manufacturers
recommendation
May vary per
institution
Variables can include
per shift, day, week,
month, lot number,
shipment, personnel

What is the goal of QC?

To detect SIGNIFICANT
errors rapidly
Report out good results
in a timely manner
Be cost effective and
simple to use
If there is an error,
identify the source of
the error

What is an error???
A wrong answer. A
significant error is
one that changes
the diagnosis
Wrong answers can
be caused by random
errors or by
systematic errors

Types of Errors
Random=Fluctuatio
ns
Temperature
Personnel

Systematic
Reagent problem
Device problem

Internal and External

Controls

Internal controls are

built into the test
device, such as a
control line in a
pregnancy test
External controls
consist of samples of a
known value that you
test as if they were a
patients sample

Rapid HIV Oraquick Advance

QC

Internal control
External controls HIV 1, HIV 2, Negative
Controls must be run and must perform as
expected before any patients results are
reported
Daily temperature documentation
Frequency of external controls:

High volume sites once per day

Low volume sites once per week
Off site or mobile location once per day

Oraquick Quality Control

Additionally, controls must be run:

With each new lot number of test

devices

With each new operator before

testing any clients for the first time

With each new shipment of test kits

received

If there is any change in the

conditions of testing (new location,
lighting, temperature, etc)

If the temperature of the test storage

area has fallen outside of range (35
C-80 C)

If the temperature of the testing area

has fallen outside of range (59-99 C)

Whenever two consecutive invalid

test results are obtained on the same
client

If there is a QC failure, repeat the QC

In summary

Perform QC according to your written

procedure
The procedure should at a minimum
follow the manufacturers
recommendation
Document, document, document
No test should be reported out unless the
QC for that test is complete and correct