Optimizing the data in direct access testing: information technology to support an emerging care model

Abstract

Direct access testing (DAT) is an emerging care model that provides on-demand laboratory services for certain preventative, diagnostic, and monitoring indications. Unlike conventional testing models where health care providers order tests and where sample collection is performed onsite at the clinic or laboratory, most interactions between DAT consumers and the laboratory are virtual. Tests are ordered and results delivered online, and specimens are frequently self-collected at home with virtual support. Thus, DAT depends on high-quality information technology (IT) tools and optimized data utilization to a greater degree than conventional laboratory testing. This review critically discusses the United States DAT landscape in relation to IT to highlight digital challenges and opportunities for consumers, health care systems, providers, and laboratories. DAT offers consumers increased autonomy over the testing experience, cost, and data sharing, but the current capacity to integrate DAT as a care option into the conventional patient-provider model is lacking and will require innovative approaches to accommodate. Likewise, both consumers and health care providers need transparent information about the quality of DAT laboratories and clinical decision support to optimize appropriate use of DAT as a part of comprehensive care. Interoperability barriers will require intentional approaches to integrating DAT-derived data into the electronic health records of health systems nationally. This includes ensuring the laboratory results are appropriately captured for downstream data analytic pipelines that are used to satisfy population health and research needs. Despite the data- and IT-related challenges for widespread incorporation of DAT into routine health care, DAT has the potential to improve health equity by providing versatile, discreet, and affordable testing options for patients who have been marginalized by the current limitations of health care delivery in the United States.

Keywords:

• Direct access testing
• consumer-initiated testing
• interoperability
• health equity and access

Acknowledgements

The authors would like to thank Osha Roopnarine, Ph.D. (Editing Science, LLC), for technical editing assistance with the manuscript.

Disclosure statement

M.S. is employed by the M Health Fairview health system, which offers DAT services, and received a speaker honorarium from LetsGetChecked; authors D.N.G., S.G.B., and M.R. are full-time, salaried employees of LetsGetChecked.

Box 1: Definitions relating to direct laboratory testing.

Direct Access Testing: Laboratory testing in which consumers can initiate testing directly, with clinical oversight maintained by the laboratory with the support of clinical professionals where appropriate

Direct-to-Consumer Testing: Laboratory testing in which consumers order testing directly and independently from clinician association, and without clinical follow up on results

Clinical Laboratory: Healthcare facility providing laboratory procedures, which may be affiliated with a clinic or healthcare system or may be a standalone laboratory

Reference Laboratory: A laboratory that performs testing on orders and/or specimens from another laboratory

FDA-approved clinical laboratory testing: Laboratory testing which has been evaluated by the US Food and Drug Administration and has been approved as an in-vitro diagnostic (IVD) methodology

Laboratory developed test (LDT): Medical grade testing that is manufactured and used within a single high complexity CLIA-certified laboratory. LDTs are generally used when a commercial test does not exist or is not appropriate for a particular patient health issue

Diagnostic Genetic Testing: Medical-grade testing performed for the purpose of confirming whether an individual carries genetic identifiers of risk

Ancestry Testing/Genealogical Testing: DNA testing to identify markers which show how an individual is related to other individuals

Wellness Testing: A general term used to describe testing which monitors indicators of health, and can encompass FDA-approved, laboratory developed, and non-medical grade testing

Additional information

Funding

The author(s) reported there is no funding associated with the work featured in this article.