CAP Accreditation is a laboratory accreditation program facilitated by the College of American Pathologists (CAP). CAP is recognized as a global leader in laboratory quality and performance standards.
A lab eligible for accreditation:
Has a qualified laboratory director and laboratory scientists
Undergoes external quality assurance and proficiency testing
Maintains a set of policies and procedures for things like quality management and document control
Laboratory personnel require specialized training to meet qualifications
Has appropriate facilities and safety equipment
A CAP-accredited laboratory undergoes several steps toward certification. Beginning with an application process, the lab submits information about their testing capabilities. Based on the details in this application, the lab must then fulfill the requirements of a checklist customized to their services. Accredited labs complete a rigorous peer inspection to ensure all elements of this checklist are in place. Specialized inspectors are employed for high-complexity labs, including molecular pathology.
On every second anniversary following the initial accreditation, labs reapply for accreditation status and undergo additional re-evaluations and inspections. In years without a CAP inspection, labs conduct a self-evaluation. The CAP certification process is more vigorous and spans a much wider spectrum of requirements than CLIA certification.
The Clinical Laboratory Improvement Amendments of 1988 are federal regulations that apply to any U.S. facility testing human specimens for health and disease reasons. The CLIA certification program is supported by the CDC, the Centers for Medical and Medicaid Services, and the Food and Drug Administration. CLIA certification differs from CAP in that its focus is medical diagnostics without requiring the broad expanse of regulatory compliance that CAP certification entails.
Much like CAP requirements, CLIA-certified labs must have:
Laboratory directors who meet certain educational and experience requirements
Routine surveys for certificate renewal every two years
The CDC considers CAP accreditation as fulfilling all federal requirements for CLIA certification, which is why these certifications are often found together.
Why Work with a CAP/CLIA Lab?
Even if you aren’t working with human clinical samples, a CAP/CLIA lab is a great choice for other applications! There are many reasons these certifications can give you peace of mind for your samples.
Human samples and clinical tests are treated with all applicable standards. You’ll receive services with an attention to quality, accuracy, and timeliness.
Patient data is retained, stored, and retrieved in a way that is compliant with regulatory processes. Data delivery is secure, and patient information is kept confidential.
CAP/CLIA certification indicates that the lab adheres to high standards, above those considered acceptable in research-use-only (RUO) facilities. Rigorous quality checks, equipment calibration, and highly trained personnel ensure efficiency and accuracy.
Routine proficiency checks mean that labs are evaluated based on their ability to produce accurate results. This minimizes errors and gives you greater confidence in the data you receive, which is crucial for making diagnostic or clinical decisions.
CAP accreditation requirements are constantly evolving and improving. This means CAP-accredited labs are always improving, too. CAP/CLIA labs stay current with the latest advancements, best practices, and regulations through ongoing education and re-certification processes. These labs are constantly integrating the newest technologies, which lead to improved testing accuracy and efficiency.
CAP is the gold standard for quality in laboratory performance. Knowing a laboratory has achieved CAP certification should instill high confidence in the quality of the work that is performed by its personnel. Combining CAP with CLIA adds the focus on medical diagnostic testing to the rigor of CAP regulations to provide a robust framework that ensures highly accurate testing results for patients and providers. Overall, labs with CAP/CLIA certifications can be trusted to deliver accurate results from precious clinical samples.