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).