Partner Labs, CLIA, and CAP
Everlywell offers access to our laboratory partners’ Laboratory Developed Tests (LDTs). An LDT has been defined by the FDA as a test that is intended for clinical use and is designed, manufactured and used within a single laboratory. There are an estimated 11,000 labs offering as many as 100,000 LDTs in the US, and LDTs are performed by most laboratories in the US.
Laboratory testing in the US is also regulated under the Clinical Laboratory Improvement Amendments (CLIA). All of our labs and tests comply with CLIA-mandated regulations, which is primarily administered by the Centers for Medicare & Medicaid Services (CMS) in partnership with state health departments. All of Everlywell’s partner labs are CLIA-certified; many are also accredited by the College of American Pathologists (CAP), the gold standard in lab testing quality regulation. All of our lab partners perform third-party proficiency testing on a quarterly basis, and most do so through CAP or equivalent organizations.
Physician Review and Partner Labs
Everlywell offers consumers the opportunity to initiate a request for a laboratory test. In many states, consumers are not permitted to order their own tests without the review and authorization of a board-certified medical doctor. To obtain independent physician review of customer test requests and results, Everlywell works with a third-party independent network of board certified physicians. These physicians provide authorization, review, and consultation services for Everlywell customers related to the customers’ tests. All customers have the ability to speak with one of the board-certified physicians prior to purchasing a test.
When Everlywell receives a test request from a customer, the request is sent to the independent physician network through a HIPAA-secure Application Programming Interface (API). A board-certified independent physician licensed to practice medicine in the state the test is ordered in then reviews the request and determines whether the test is appropriate for the customer. If the physician determines that the test is not appropriate for the customer, the physician will notify Everlywell, who will contact the customer and provide a refund. If the physician determines that the test is appropriate for the customer, the physician will order the test. After the sample is collected, sent to the partner laboratory, processed and tested, the partner laboratory will send the customer’s test report to the physician for review. After the independent physician reviews and approves the results, they are released to Everlywell and delivered to the customer and can be viewed in the customer’s online results dashboard.
Some of Everlywell’s test markers have a predetermined “critical value.” The physician network maintains a list of all “critical values” and triages all out-of-range results. If a customer has a critical value result, the physician network’s customer services team will contact the customer via telephone. In the case of STD or Lyme testing, if a customer has a positive result Everlywell will hold the customer’s results and not release them to the customer until the physician network has contacted the customer directly (or after 3 failed attempts at contact). Customers with positive STD test results may be offered a free STD consultation with a physician and prescription for treatment where appropriate. Customers with a positive screen for Lyme Disease may be offered a free consultation with a physician and prescription for treatment where appropriate.« Back to The Science