Quality Control

Title
Establishing Best Practices in
Quality Control Management

Introduction
Quality control management in laboratories has become more complex in recent years. While juggling compliance requirements
and navigating budget concerns have always been pain points for lab managers, new challenges—such as higher-than-
ever volumes of tests and supply chain uncertainty—must be addressed. The post-pandemic economy suffers from both an
unprecedented reduction in workforce and increased cost for employment of lab staff (Wolski 2022), and many laboratories
today are not only inundated with tests but with increasingly shorter requested turnaround times (TATs), resulting in an even
greater impact on reduced staff numbers. A focus on streamlining QC practices in the lab can result in less pressure on staff and
increased confidence in the reliability and medical usefulness of test results.

Evaluating your current QC system workflow These points can also be used as a benchmark for determining if
Before assessing how to improve QC processes, first the lab is functioning well:
determine what is potentially missing in the current workflow.
■ Re-evaluate goals
The typical QC workflow for setting up a laboratory should
Because determining the acceptable risk level for tests is the
consist of five basic points: establishing goals, assessing
foundation of setting QC system goals, ensure the lab has
laboratory risk, developing a plan, implementing the plan, and
clearly defined the standard for acceptable or unacceptable test
reviewing the outcomes (see Fig. 1).
results. Then, re-evaluate the analytical goals the lab strives to
achieve. This can include goals such as meeting requirements for
Quality Control System accreditation or analyte-specific performance. Take note of which
Workflow Technique goals are not currently being met so they can be addressed.
Conduct Reviews
To assess relevance ■ Review risk assessment
and effectiveness
When reviewing a laboratory’s risk assessment, be sure to
Establish Goals identify issues such as which tests might have an increased
The critical
risk of harm to patients if the results are inaccurate or what the
first step
Develop a Plan Implement Plan probability of failure may be for an instrument. An essential part
Defining laboratory Using processes
of establishing QC best practices is ensuring awareness of
policies and procedures
potential risks and their effect on test quality.
Laboratory Risk
Assessment
■ Review the QC plan and training materials
Assess laboratory Have the policies and procedures the laboratory should follow been
conditions
clearly defined? Doing so helps ensure consistency. Re-evaluate the
By following this path of workflow technique, the laboratory can build details of the QC plan, such as acceptable limits for bias, frequency
an effective internal quality control system to meet basic accreditation of including QC materials for each analyte, statistical parameters,
requirements for quantitative tests. The process of establishing goals, and timing of materials within the run of patient samples.
developing a clearly defined plan, implementing carefully thought out Laboratories should also re-examine QC materials based on their
procedures, and regular review of the system will demonstrate a serious
usefulness to the lab; for example, is having a long shelf life important
commitment to maintaining high quality analytical performance, and
ultimately providing good patient test results. to the process? Are the current QC materials meeting that need?

Documenting the QC system plan according to required protocols

and creating standardized training materials is crucial to ensure all
Fig 1: Quality control system flowchart
staff have been properly trained by qualified personnel, which can
help in later assessing how well the system is functioning.

Visit bio-rad.com/qualitycontrol for more information.

Evaluating your current QC system workflow
■ Review feedback and results
In the day-to-day activity, review and evaluate the efficacy of Full Life
Full Life
the QC plan to determine any necessary changes. This could of Lot of Lot Lot 1

be reviewing data and verifying if the system is too sensitive, Lot 2

resulting in too many false positive results, or insensitive, missing

Early
Crossover
Early Lot 3
Crossover
important errors, or reviewing meeting notes to address open
action items. Assess the system regularly to quickly catch and
resolve issues.
0 1 2 3 4 5

5 Year Timeframe
QC best practices and their impact
After assessing the current QC workflow, focus on Fig 2: Lot changes over five-year timeframe
streamlining existing processes with the following modern
best practices to help overcome post-pandemic challenges.

Automation Conclusion
The adage “Work smarter, not harder,” applies directly to modern Setting up a laboratory to function at its best can be
quality control needs. With laboratory workforce reductions and challenging, especially considering increasing complexities
ever-increasing volumes of tests, employ automated solutions and and demands. By adopting the above QC best practices and
technology wherever possible to fill the gaps. This could include workflow improvement strategies, laboratories can continue
introducing robotics to minimize manual work for personnel, achieving consistent QC results—and potentially even exceed
or automated environmental monitoring equipment to maintain current outputs—saving the lab time, effort, and cost.
critical cleanroom standards. Data management software such as
Bio-Rad Unity solutions can streamline many of the manual steps
of evaluating results. Automation increases reliability and cuts References
1 Chun, S., Lee, S., Lee, W., Min, W., and Yoon, S. Strategies to
time across the board. Experts also predict that breakthroughs in
shorten turnaround time in outpatient laboratory. (October 2022).
artificial intelligence (AI) will play a critical role in the near future for Journal of Clinical Laboratory Analysis, Volume 36, Issue 10. Retrieved
clinical laboratories in optimizing workflows (Wolski 2022). from: https://doi.org/10.1002/jcla.24665, accessed June 9, 2023.
2 Cooper, W.G. The Financial Implications of Early QC Lot
Strategizing QC implementation Conversion. Retrieved from: https://www.qcnet.com/resources/
Supply chain unreliability and interruptions, staff shortages, qc-articles/the-financial-implications-of-early-qc-lot-
and shorter TATs all drive the need for implementing strategies conversion, accessed May 6, 2023.
for QC optimization. For instance, assessing current workflow 3 Hawkins, R.C. Laboratory Turnaround Time. (2007). The Clinical
gaps and implementing new strategies can greatly increase TAT Biochemist. Reviews/Australian Association of Clinical Biochemists.
achievement. A 2022 study at the University of Ulsan College Volume 28. 179-94.
of Medicine and Asan Medical Center in Seoul, South Korea
found that altering lab strategy to include the combination of an
4
Wolski, C. 10 Clinical Laboratory Predictions for 2023. (2022,
November 14). Retrieved from Clinical Lab Products: https://
additional autoanalyzer and real-time monitoring system increased clpmag.com/diagnostic-technologies/10-clinical-laboratory-
their TAT achievement rate from 78.5% to 88.7% over the course predictions-for-2023/, accessed May 5, 2023.
of a year (Chun et al. 2022).
In terms of combating supply chain issues and their associated
cost, consider reserving lots of QC materials to minimize
the number of required QC crossover studies (also called lot
change studies). Findings from a Bio-Rad QC material crossover
study show that over a five-year timeframe, a small laboratory
performing two crossover studies instead of three could save
an average of $2,921 for only one control product on one
instrument using six reagents (see Fig. 2) (Cooper 2023).

BIO-RAD is a trademark of Bio-Rad Laboratories, Inc. All trademarks used herein are the property of their respective owner.

Bio-Rad
Laboratories, Inc.

Clinical Website www.bio-rad.com/diagnostics U.S. 1 800 224 6723 Australia +61 (2) 9914 2800 Austria +43 (0) 1 877 89 01 9 Belgium +32 (0) 3 710 53 00
Brazil +55 11 3065 7550 Canada +1 514 334 4372 China +86 21 6169 8500 Czech Republic +420 241 431 660 Denmark +45 44 52 10 00
Diagnostics Group Finland +358 9 804 22 00 France +33 (0) 1 47 95 60 00 Germany +49 (0) 89 31884 393 Greece +30 210 7774396 Hong Kong +85 2 2789 3300
Hungary +36 1 459 6190 India +91 124 4029300 Israel +972 03 963 6025 Italy +39 024 94 86 600 Japan +81 3 6361 7070 Mexico +52 (55) 5488 7670
The Netherlands +31 (0) 318 540 666 New Zealand +64 (9)415 2280 Norway +47 23 38 41 30 Poland +48 22 331 99 99 Portugal +351 21 47 27 700
Republic of Korea +82 080 007 7373 Russia +7 (495) 721-14-04 Singapore +65 6415 3170 South Africa +27 11 442 8508 Spain +34 91 490 6580
Sweden +46 844 98053 Switzerland +41 (0) 61 717 9555 Taiwan +886 (2) 2578-7189 Thailand (662) 651 8311 United Kingdom +44 (0) 1923 471301

QW-1010 © 2023 Bio-Rad Laboratories, Inc. 2023/07