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 High complexity Moderate complexity Moderate complexity Waived 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 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 There should be at least one control per reportable result Reportable results include positive and negative results Reportable results include positive and negative results Follow manufacturer’s recommendation Follow manufacturer’s recommendation May vary per institution May vary per institution Variables can include per shift, day, week, month, lot number, shipment, personnel Variables can include per shift, day, week, month, lot number, shipment, personnel

5. What is the goal of QC? To detect SIGNIFICANT errors rapidly To detect SIGNIFICANT errors rapidly Report out good results in a timely manner Report out good results in a timely manner Be cost effective and simple to use Be cost effective and simple to use If there is an error, identify the source of the error 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 TemperaturePersonnelSystematic 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 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 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 Internal control External controls –HIV 1, HIV 2, Negative 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 Daily – temperature documentation Frequency of external controls: Frequency of external controls: High volume sites once per day High volume sites once per day Low volume sites once per week Low volume sites once per week Off site or mobile location once per day 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 lot number of test devices With each new operator before testing any clients for the first time With each new operator before testing any clients for the first time With each new shipment of test kits received With each new shipment of test kits received If there is any change in the conditions of testing (new location, lighting, temperature, etc) 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 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) 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 Whenever two consecutive invalid test results are obtained on the same client If there is a QC failure, repeat the QC If there is a QC failure, repeat the QC

11. In summary In summary Perform QC according to your written procedure Perform QC according to your written procedure The procedure should at a minimum follow the manufacturer’s recommendation The procedure should at a minimum follow the manufacturer’s recommendation Document, document, document Document, document, document No test should be reported out unless the QC for that test is complete and correct No test should be reported out unless the QC for that test is complete and correct