CorePlus Direct Access Testing Policy

PURPOSE: This policy outlines the procedures and requirements for Direct Access Testing (DAT) in accordance with the Clinical Laboratory Improvement Amendments (CLIA) regulations.

SCOPE: This policy applies to all departments working with DAT.\

DEFINITION: Direct Access Testing (DAT) is generally defined as consumer-initiated testing of human specimens, as opposed to tests ordered by a physician. It allows individuals to request and receive certain laboratory tests without a physician or healthcare provider’s intervention.

COMPLIANCE WITH CLIA: All laboratory procedures, equipment, personnel, and reporting for DAT will adhere to CLIA regulations and standards.

TESTS OFFERED: The list of available tests will be periodically reviewed and updated as necessary.

PATIENT CONSENT: Before any DAT procedure, the patient will provide written informed consent, indicating understanding of benefits, risks, and limitations of the testing.

TEST PERFORMANCE AND QUALITY CONTROL: All DAT procedures will be performed with the same level of accuracy, precision, and quality control as other laboratory tests.

REPORTING RESULTS:

Test results will be provided directly to the individual requesting the test.
All results will include clear and easily understood interpretations or reference ranges.
Any critical or unexpected results will include guidance on seeking immediate medical attention or follow-up.

RECORD RETENTION: Records of all DAT will be retained for a minimum period as required by CLIA and state regulations.

CONFIDENTIALITY: All DAT results are confidential. They will only be released to the individual who requested the test or to an authorized representative.

PERSONNEL: Only appropriately trained and credentialed personnel will perform DAT.

PATIENT EDUCATION:

Informational material will be available to individuals considering DAT, detailing the scope and limitations of each test and pre-testing conditions that may affect test results (e.g. the need for fasting, eating or drinking, effect of specific medications, etc.)
Patients will be informed that DAT results should be discussed with a healthcare professional for a comprehensive understanding.

LIMITATIONS: Patients will be informed that:

DAT is not a substitute for regular medical check-ups.
Some tests may have false positives or false negatives.
Not all medical conditions can be detected through DAT.

REVIEW AND UPDATE: This policy will be reviewed annually and updated as necessary to remain in compliance with any changes in CLIA regulations or best practices.

REFERENCES:

Direct Access Testing (DAT) and the Clinical Laboratory Improvement Amendments (CLIA) Regulations: Frequently Asked Questions. Accessed on September 27, 2023.
American Society for Clinical Pathology. Policy Statement: Direct Access Testing (Policy Number 01-02).