Clinical Diagnostics • Quality Control

Effectively Manage Risk with Bio-Rad's Independent Quality Controls

For Confidence in Your Patient Results

Before patient test results can be reported and used for diagnosis, prognosis or treatment planning, test systems should be assessed with quality controls.

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Independent Quality Controls

For decades, Bio-Rad Quality Controls experts have developed multi-analyte, independent controls for monitoring the precision of test systems and methods. With independent quality controls, you can count on consistent quality products that help assure the reliability of your patient results.

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CLIA

For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytical process.

42 CFR Part 493.1256 Medicare, Medicaid, and CLIA Programs; Laboratory Requirements Relating to Quality Systems and Certain Personnel Qualifications; Final Rule

Be confident that patients are getting the reliable results they deserve.

The Case for Independent Quality Controls

Any patient result reported without monitoring quality control is at risk. The better way to monitor system performance is with independent controls from a third-party manufacturer.

ISO 15189

Laboratory shall use quality control materials that react to the examining system in a manner as close as possible to patient samples. Use of independent third-party control materials should be considered, either instead of, or in addition to, any control materials supplied by the reagent or instrument manufacturer.

ISO 15189:2012. Medical laboratories – requirements for quality and competence. Clause 5.6.2.2 Quality Control Materials

Independent quality controls are an essential part of a quality control system.

  • They provide an independent unbiased assessment of your lab's test system or method performance because they are manufactured independently of the instrument, reagents and calibrators
  • They give you greater confidence in your results because they help detect errors that instrument manufacturer controls miss

Many instrument manufacturers provide calibrators and control materials for their own test systems.

Instrument controls are often designed and manufactured from the same materials as the calibrators. The controls may then mimic the calibrators and be less sensitive to changes in device performance.

Instrument controls may fail to detect:

  • Calibration errors
  • Procedural errors
  • Errors due to faulty equipment
  • Errors due to shifts in following maintenance
Failing to detect system and process errors can lead to accepting inaccurate patient results that can be medically important.

Bio-Rad experts can help you strategize and tailor the right quality control program for your lab.

Contact a Bio-Rad QC Expert today!

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For a truly independent assessment of the test system, it is very important to use controls that are not provided by the instrument manufacturer.

Carol Bartlett, QC Coordinator, USA

If you work with manufacturer controls, you will miss a lot of analytical problems that may have an impact on patient results. Moreover, testing independent controls is a requirement of ISO 15189:201

J. M. Gras, MD
Clinique Saint-Luc, Bouge, Belgium

Bio-Rad's independent controls with a longer shelf life enable you to use the same control lot over multiple batches of reagents and calibrators. This way you can detect shifts from lot-to-lot variation.

More laboratories trust Bio-Rad for quality control products than any other manufacturer. Count on Bio-Rad for consistent product quality and reliable patient results.

Bio-Rad's Independent Quality Controls

  • Blood gas controls
  • Cardiac assessment controls
  • Chemistry controls & serum indices
  • Coagulation controls
  • Diabetes/hemoglobin controls
  • Hematology controls
  • Immunoassay controls
  • Immunology/protein controls
  • Infectious disease controls
  • Molecular controls
  • Premium controls
  • QC products in Dimension Vista vials
  • Therapeutic drug monitoring controls
  • Toxicology: drugs-of-abuse controls
  • Toxicology: specialty controls
  • Urinalysis controls