1. Quality Control Barbara Weberman MT(ASCP)
Oakland County Health Division
Laboratory Supervisor

2. 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

3. 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

4. How many, how often?
There should be at least one control per reportable result
Reportable results include positive and negative results
Follow manufacturer’s recommendation
May vary per institution
Variables can include per shift, day, week, month, lot number, shipment, personnel

5. 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

6. 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

7. Types of Errors Random=Fluctuations Temperature Personnel Systematic
Reagent problem
Device problem

8. 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

9. 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

10. 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

11. 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