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 manufacturer’s
recommendations in the package insert
 How many, how often?
 There should be at  Follow manufacturer’s
least one control per recommendation
reportable result  May vary per
 Reportable results institution
include positive and  Variables can include
negative results 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=Fluctuations Systematic
Temperature Reagent problem
Personnel 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 patient’s
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 manufacturer’s recommendation
 Document, document, document
 No test should be reported out unless the
QC for that test is complete and correct