Why CLIA/CAP Certification Matters

At-Home Diagnostic Testing

Why CLIA/CAP Certification Matters

Ash Team

Clinical Laboratory Improvement Amendments (CLIA) and the College of American Pathologists (CAP) are standards and regulations for clinical and laboratory testing. CLIA certification and CAP accreditation offers laboratories a structured approach to quality management and process enhancement. This process plays a pivotal role in pinpointing areas for improvement, fostering a culture of ongoing progress. 

From the patient's perspective, CLIA certification and CAP accreditation serves as a guarantee that laboratory test results are not only accurate but also reliable and promptly delivered. Certification ensures that laboratories adhere to stringent guidelines, safeguarding patient privacy and confidentiality throughout the testing process. In essence, CLIA/CAP acts as a dual commitment, enhancing laboratory operations for improved internal processes while instilling trust in patients through a demonstrated commitment to quality and privacy.

What is CLIA certification?  

In 1988, the United States Congress enacted the Clinical Laboratory Improvement Amendments (CLIA) with the aim of establishing standards for specific laboratory testing. This legislation grants the authority to set guidelines to guarantee the accuracy, reliability, and timeliness of test results, regardless of the location or performer of the test. 

The CLIA requirements take into account the complexity of the test and the type of laboratory conducting the testing. The official CLIA program requirements can be found in the relevant law, regulations, and rulings. Additionally, it is important to note that state, local, and accreditation requirements may impose more stringent standards. 

What is CAP accreditation?

The CAP Laboratory Accreditation Program has been granted deeming authority by the Centers for Medicare and Medicaid Services (CMS), enabling CAP inspection to substitute for a CMS inspection. Notably, the CAP maintains deemed status not only with the Joint Commission but also with prominent organizations such as the United Network for Organ Sharing, the National Marrow Donor Program, the Foundation for the Accreditation of Cellular Therapies, and various US state agencies.

A distinctive feature of the CAP is its peer-inspection model, which proves advantageous for both the laboratories undergoing inspection and those providing the inspection teams. This shared experience ensures a comprehensive evaluation. Moreover, the CAP stands out by offering specialty inspectors specifically trained for critical, high-complexity disciplines. This commitment to excellence and specialization reinforces the integrity of the accreditation program, providing healthcare professionals with a trusted standard for laboratory quality.

CLIA/CAP labs for at-home diagnostics programs 

Providers can set up at-home diagnostics programs to screen for cancers and illnesses, push digital products, offer medication adherence services, and perform other population screening measures. They may partner with diagnostics companies that utilize a network of telemedicine labs that hold CLIA certification and CAP accreditation. For diagnostics companies, using a network of CLIA/CAP labs to process at-home tests may attract higher quality provider clients interested in reliable and marked guidelines for testing.   

Ash Wellness and CLIA/CAP labs

Ash Wellness works exclusively with CLIA certified, as well as some CAP accredited, labs. Our clients have access to this national lab network where technicians around the country process results 7 days per week, usually within 3-5 days from samples arriving at the lab. In addition to our lab network, physician network, white-labeled test kits, and digital tools, Ash Wellness offers several linkage to care options.  

When a patient obtains a result through the Patient Portal, the text can be adjusted to incorporate a referral phone number or another preferred contact service. Patients with non-critical results can explore the resources page, which includes local care options for more information on ongoing screening or additional programs. We also send alerts to client care teams, enabling a team member to reach out to a patient with a reactive test and schedule treatment or ongoing care. Any critical result triggers a flag within the Provider of Record API, prompting a clinician to contact the patient within 48 hours.

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