Laboratory Quality Assurance and Standardization Programs

Quality Assurance

Laboratory Quality Assurance (QA) encompasses a range of activities that enable laboratories to achieve and maintain high levels of accuracy and proficiency despite changes in test methods and the volume of specimens tested. A good QA system does these four things:

• establishes standard operating procedures (SOPs) for each step of the laboratory testing process, ranging from specimen handling to instrument performance validation;
• defines administrative requirements, such as mandatory recordkeeping, data evaluation, and internal audits to monitor adherence to SOPs;
• specifies corrective actions, documentation, and the persons responsible for carrying out corrective actions when problems are identified; and
• sustains high-quality employee performance.

Laboratory Standardization

Laboratory Standardization is achieved when test results have the same analytical accuracy and precision across measurement systems, laboratories, and over time. CDC’s Standardization Programs consist of three main steps:

1. Reference System consisting of reference methods and reference materials with target values assigned by the reference methods,
2. Traceability procedure in which participants use the reference materials created in the previous step to calibrate their tests or to verify the analytical accuracy and precision of their testing system,
3. Verification procedure in which the analytical accuracy and precision of the test calibrated in the previous step is being assessed under routine testing conditions.

Well-executed standardization programs greatly improve the quality of laboratory measurements that are used to detect signs of illnesses and to guide interventions to prevent or treat illnesses. Standardization also ensures the production of credible and comparable data across laboratories—a boon to epidemiologists and researchers who may need to pool data from multiple sources.

CDC offers customized QA and standardization programs to help laboratories improve the quality and reliability of their measurement procedures. The specific CDC services that are offered are:

• Reference materials
• Proficiency testing
• Training
• Guidelines
• Consultations

Each CDC laboratory QA and standardization program is voluntary and most are free of charge.