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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

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quality control

Quality Control

Barbara Weberman MT(ASCP)

Oakland County Health Division

Laboratory Supervisor

clinical laboratory improvement act of 1988 clia 88
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 control1
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 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

How many, how often?
what is the goal of qc
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
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

Temperature

Personnel

Systematic

Reagent problem

Device problem

Types of Errors
internal and external controls
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
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
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
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