Basics of laboratory quality control

Ola H. Elgaddar
MBChB, MSc, MD, CPHQ Lecturer of Chemical Pathology Medical Research Institute Alexandria University Ola.elgaddar@alex-mri.edu.eg

Total Quality Management (TQM)

- A continuous approach that seeks to improve quality and performance which will meet or exceed customer expectations. - This can be achieved by integrating all quality-related functions and processes throughout the organization. - TQM requires the involvement of everyone; management, workforce, suppliers, and customers (feedback) - Divided into four sequential categories: plan, do, check, and act (the PDCA cycle)

In a medical lab, we have three main stages that need control:

1) Pre-analytical 2) Analytical 3) Post-analytical
All of them should be under tight control

1) Pre-analytical:
Patient & specimen identification Patient preparation Specimen collection, transport and handling Monitoring personnel

2) Analytical:
Internal quality control (IQC) External quality assessment (EQA)

IQC is used, on daily basis, in the decision to accept or reject results of patients samples and enables the lab to describe and monitor the quality of its work. EQA permits a comparison of quality between laboratories and thus describes the state of the art for that area of laboratory work encompassed by the EQA program . It is used to confirm results of IQC

3) Post-analytical:
Transcriptional errors Unclear report format or information

IQC procedures
A stable control material which mimics patients sample is analyzed (day to day) Individual measurements are plotted on a control chart (Levey Jennings charts) Evaluation whether measurement is in control (Westgard multi-rules)

Control material
IFCC defines control material as a solution analyzed solely for Q.C. purpose and not for calibration Criteria to be considered:
1. 2. 3. 4. 5. Matrix Reconstitution Stability Assayed or un assayed Appropriate analyte level

1) Matrix:
-BASE from which the control material is prepared.

-Ideally the same matrix as specimen so that they behave like a specimen. - Controls available are HUMAN BASED or BOVINE BASED

2) Reconstitution:
Liquid / lyophilized (Liquid controls better) Reconstitution material Quantity of solvent (volume?) Mixing Waiting (when to use the reconstituted control) Vial to vial variation (Standardization of these factors necessary)

3) Stability:
Expiry date and stability after reconstitution should be considered

Desirable is one year supply of the same lot, so that the lab can have its own QC range for a longer period of time.

4) Assayed / Un-assayed QC:

Assayed QC material are the usually used type in our labs They have manufacturer values for each instrument / method Those values should be considered as guidelines only till each lab establish its own QC range Minimum period of time for a lab to establish its own range is 20 days Ideally, a new QC lot should be run, hand in hand with the old lot, its values are established before it is run routinely.

5) Appropriate analyte level

The used QC material should be covering the measured range of the analyte, both in its normal and pathological range.

It is preferable to have a control value near the medical decision level. Ideally, there are two levels of QC material used in Chemistry analysis and three levels for hormones and tumor markers.

Plotting QC result on Levey Jennings control chart

Mean and SD of QC material (manufacturer or each labs values) Y-axis: control value Vs X-axis: time of run

Most autoanalyzers plot the charts, otherwise they should be drawn manually
A chart is plotted for each control level

Evaluating QC results using Westgard rules

Detects whether results are in control or not. Detects the type of laboratory error

 Random error, RE, or imprecision is described as an error that can be either positive or negative, whose direction and exact magnitude cannot be predicted, where the distribution of results when replicate measurements are made on a single specimen. Usually, due to error in pippetting

 Systematic error, SE, or inaccuracy is an error that is always in one direction, displacing the mean of the distribution from its original value. In contrast to random errors, systematic errors are in one direction and cause all the test results to be either high or low. Either constant or proportionate Usually, due to error in calibration

1 reading exceeding 2 SD Warning

1 reading exceeding 3 SD Random error Rejection

2 readings exceeding 2 SD Systematic error Rejection

4 readings exceeding 1 SD, on one side of mean Systematic error Rejection

10 readings on the same side of the mean Systematic error Rejection

2 readings, their sum exceeds 4 SD Random error Rejection