Quality ControlQuality Control

Barbara Weberman MT(ASCP)Barbara Weberman MT(ASCP)

Oakland County Health Oakland County Health Division Division

Laboratory SupervisorLaboratory Supervisor

Clinical Laboratory Clinical Laboratory Improvement Act of 1988 (CLIA Improvement Act of 1988 (CLIA

‘88)‘88)Set Minimum Standards for Quality Set Minimum Standards for Quality

Control (QC)Control (QC)

Placed tests into complexity categoriesPlaced tests into complexity categories High complexity High complexity Moderate complexity Moderate complexity WaivedWaived

The Rapid HIV tests are considered waivedThe Rapid HIV tests are considered waived

Quality ControlQuality Control

Process that tracks the ability of Process that tracks the ability of reagents, instrumentation, and reagents, instrumentation, and personnel to obtain an accurate resultpersonnel to obtain an accurate result

How many controlsHow many controls

How oftenHow often

Minimum requirements for waived Minimum requirements for waived tests tests are the manufacturer’s are the manufacturer’s recommendations in the package insertrecommendations in the package insert

How many, how often?How many, how often?

There should be at There should be at least one control least one control per reportable per reportable resultresult

Reportable results Reportable results include positive include positive and negative and negative resultsresults

Follow Follow manufacturer’s manufacturer’s recommendationrecommendation

May vary per May vary per institutioninstitution

Variables can Variables can include per shift, include per shift, day, week, month, day, week, month, lot number, lot number, shipment, personnelshipment, personnel

What is the goal of QC?What is the goal of QC? To detect SIGNIFICANT To detect SIGNIFICANT

errors rapidlyerrors rapidly Report out good Report out good

results in a timely results in a timely mannermanner

Be cost effective and Be cost effective and simple to usesimple to use

If there is an error, If there is an error, identify the source of identify the source of the errorthe error

What is an error???What is an error???

A wrong answer. A A wrong answer. A significantsignificant error is error is one that changes one that changes

the diagnosis the diagnosis

Wrong answers can Wrong answers can be caused by be caused by

randomrandom errors or errors or by by systematicsystematic

errorserrors

Types of ErrorsTypes of Errors

RandomRandom=Fluctuatio=Fluctuations ns

TemperatureTemperature

Personnel Personnel

SystematicSystematic

Reagent problemReagent problem

Device problemDevice problem

Internal and External Internal and External ControlsControls

Internal controls are Internal controls are built into the test built into the test device, such as a device, such as a control line in a control line in a pregnancy testpregnancy test

External controls External controls consist of samples of consist of samples of a a known valueknown value that you that you test as if they were a test as if they were a patient’s sample patient’s sample

Rapid HIV Oraquick Advance Rapid HIV Oraquick Advance QCQC

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 documentationDaily – temperature documentation Frequency of external controls: Frequency of external controls:

High volume sites once per dayHigh volume sites once per day Low volume sites once per weekLow volume sites once per week Off site or mobile location once per dayOff site or mobile location once per day

Oraquick Quality ControlOraquick Quality Control

Additionally, controls must be run: Additionally, controls must be run: With each new lot number of test With each new lot number of test

devicesdevices With each new operator before With each new operator before

testing any clients for the first timetesting any clients for the first time With each new shipment of test kits With each new shipment of test kits

receivedreceived If there is any change in the If there is any change in the

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

If the temperature of the test storage If the temperature of the test storage area has fallen outside of range (35 area has fallen outside of range (35 C-80 C)C-80 C)

If the temperature of the testing area If the temperature of the testing area has fallen outside of range (59-99 C)has fallen outside of range (59-99 C)

Whenever two consecutive invalid Whenever two consecutive invalid test results are obtained on the same test results are obtained on the same clientclient

If there is a QC failure, repeat the QCIf there is a QC failure, repeat the QC

In summaryIn summary

Perform QC according to your written Perform QC according to your written procedureprocedure

The procedure should at a minimum The procedure should at a minimum follow the manufacturer’s follow the manufacturer’s recommendationrecommendation

Document, document, documentDocument, document, document No test should be reported out unless the No test should be reported out unless the

QC for that test is complete and correctQC for that test is complete and correct