ANALYTICAL PROCESS ANALYTICAL PROCESS CONTROLCONTROL

QC FOR QUALITATIVE TESTS

Dr. Bernard Natukunda

INTERNAL QUALITY CONTROL INTERNAL QUALITY CONTROL (IQC)(IQC)

IQC REFERS TO THE SET OF PROCEDURES UNDERTAKEN BY THE LABORATORY

STAFF FOR THE

CONTINUOUS AND IMMEDIATE

MONITORING OF LABORATORY WORK IN ORDER TO DECIDE WHETHER THE

RESULTS ARE RELIABLE ENOUGH TO BE RELEASED.

What is IQC?What is IQC?

• The regular testing of quality control [QC] material along with the patient samples

• Comparison of the QC results to specific statistical limits [ranges]

• Rejection of patient results if QC is outside of limits

WHAT IS THE MOST COMMON WHAT IS THE MOST COMMON LABORATORY ERROR?LABORATORY ERROR?

TRANSCRIPTION

Not technical

Specimen

• Appropriate specimen

• Collection method

• Delivery system

PPTC, Wellington, NZ

IDENTIFICATION SYSTEMIDENTIFICATION SYSTEM

QC of Stains and Reagents

Proper stains

Reagents

Temperature chart: Incubator

Refirgerator storage: daily temp monitoring

PPTC, Wellington, NZ

PPTC, Wellington, NZ

Sources of Error

• If you encounter an unusual pattern– rule out error by checking – repeat the test

• Report if repeat testing yields same result, or refer to a reference laboratory for confirmation

QC in Blood Transfusion Service

Donors Recipients

Safety Precautions

Recruit – Screen – Bleed test – process – Xmatch transfuse – follow up

Blood Transfusion ServiceBlood Bank

QC in Blood Bank Technology

• Donor services

• Blood grouping

• Cross-match & antibody screening

• Transfusion

QC in Blood Bank

• Positive and negative controls on all tests

• Reverse grouping

• Good documentation, SOPs etc

• Equipment monitoring, calibration, maintenance

QC of Rapid Tests for Infectious Diseases

Infectious Diseases Serology QC of Rapid Methods

• IQC• Positive controls• Negative controls

» How often?» Where do you get the controls from?

Qualitative versus Quantitative

• Quantitative test – measures the amount of a substance present

• Qualitative test– determines whether the substance being tested

for is present or absent

What is Quality Control?

• Process or system for monitoring the quality of laboratory testing, and the accuracy and precision of results

• Routinely collect and analyze data from every test run or procedure

• Allows for immediate corrective action

Designing a QC Program

• Establish written policies and procedures– Corrective action procedures

• Train all staff

• Design forms

• Assure complete documentation and review

MURAKOZE CYANE