Clinical and laboratory testing play a crucial role in the diagnosis, treatment, and management of various health conditions. To ensure the accuracy and reliability of these tests, laboratories must meet certain standards and regulations. 

One such regulation is the requirement to obtain certification from the Clinical Laboratory Improvement Amendments (CLIA) and the College of American Pathologists (CAP). In this blog, we will explore what it means for a lab to be CLIA/CAP certified, the benefits of certification, and the process of obtaining certification.

Are clinical laboratories or diagnostic tests certified by the FDA?

Laboratory developed tests (LDTs) are not sold for use in other laboratories, so they do not require approval by the FDA, though they are still subject to potential Centers for Medicare and Medicaid Services (CMS) or FDA monitoring. The FDA is responsible for categorizing diagnostic tests based on complexity, reviewing requests for Waiver by Application, and developing rules for CLIA complexity categorization. 

What is CLIA certification?

The Clinical Laboratory Improvement Amendments (CLIA) of 1988 is a federal law that regulates clinical laboratory testing. The law establishes standards for all United States facilities that test human specimens to ensure the accuracy, reliability, and timeliness of patient test results. 

The law requires all laboratories that perform testing on human specimens for diagnosis, treatment, or prevention of disease to obtain a CLIA certificate. Centers for Medicare and Medicaid Services (CMS), the Food and Drug Administration (FDA), and the Centers for Disease Control and Prevention (CDC) all play a role in ensuring quality lab testing in the United States. CLIA covers around 320,000 laboratory entities. 

The CLIA certification process involves an on-site survey and evaluation of the laboratory's policies, procedures, and practices to ensure compliance with the CLIA regulations. The survey covers several areas, including personnel qualifications, quality control, proficiency testing, patient test management, and laboratory facilities. The laboratory must meet or exceed the minimum standards set by the CLIA program to obtain and maintain certification.

What is CAP certification?

The College of American Pathologists (CAP) is a leading organization that accredits and certifies clinical laboratories and makes sure that all labs in the US are being routinely assessed. CAP accreditation is a voluntary program that provides an independent and objective evaluation of laboratory services. The CAP accreditation process involves a rigorous on-site inspection and evaluation of the laboratory's practices, procedures, and facilities. 

This on-site occurs every two years to assess compliance with program requirements. The peer-based inspection model uses teams of practicing professionals qualified through a CAP training program. While inspections are historically performed in-person, laboratories in good standing can participate in a virtual inspection by providing electronic access to their evidence of compliance with CAP checklist requirements.

What are the benefits of certification? 

For the laboratory, CLIA/CAP certification provides a framework for quality management and process improvement. The certification process helps to identify areas for development and promotes a culture of continuous advancement. Certification also provides a competitive advantage, as it demonstrates the laboratory's commitment to quality and patient care.

For patients, CLIA/CAP certification ensures that laboratory test results are accurate, reliable, and timely. Patients can have confidence in the laboratory's ability to provide high-quality testing and diagnosis. Certification also ensures that laboratories follow strict guidelines to protect patient privacy and confidentiality.

How does CLIA/CAP interact with HIPAA?

All protected health information (PHI) should be sent via HIPAA compliant avenues, including patient information sent to CLIA/CAP certified labs related to at-home diagnostic testing. HIPAA governs the privacy and security of patients' health information. It sets national standards for the protection of individually identifiable health information and regulates how PHI can be used and disclosed.

Is Ash Wellness CLIA/CAP certified? 

Ash Wellness works exclusively with CLIA certified labs. Some of our lab partners are also CAP accredited. 

Schedule a time to talk with Ash Wellness about self-collection testing services, including access to our national lab network, for your patient population. 

What about lab reporting requirements?

As laid out by the CDC, reporting for infectious disease can be provider based, laboratory based, or both. Ash Wellness tests are reported by our partner labs to the Department of Health (DOH) as part of their own compliance mandate. We work with our lab partners to verify patient information so all reports made are timely and accurate. 

If clients require patient information for additional reporting purposes, we can collect and relay necessary data. 

Conclusion: 

CLIA and CAP certification are important regulatory requirements for home diagnostics and clinical laboratories. Certification ensures that laboratories meet or exceed minimum quality standards and provides a framework for continuous improvement. For patients, certification ensures the accuracy and reliability of laboratory test results and promotes patient confidence in the laboratory's ability to provide high-quality testing and diagnosis. 

Laboratories that obtain and maintain CLIA and CAP certification demonstrate their commitment to quality and patient care, and they are better positioned to compete in the healthcare marketplace.

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