Classification: Position Paper
Date: July 2012, Revised 2021
Status: Approved by ASCLS House of Delegates July 1, 2021

Introduction

The traditional United States healthcare model places a clinician in control of determining what screening, diagnostic or therapeutic monitoring laboratory tests are to be performed on a patient.  Results of these tests are reported to the clinician who assumes responsibility for communicating results to the patient and recommending a wellness or treatment plan. This model is reinforced by federal regulations, some state laws, accreditation regulations and compliance laws (e.g., Centers for Medicare and Medicaid Services (CMS), CLIA accrediting agencies, Office of the Inspector General (OIG), etc.) that define reasonable and necessary medical services. 1

A movement that empowers consumers to take responsibility for their own healthcare has created a major paradigm shift in healthcare.  This shift moves from clinician-driven focus to consumer-driven focus, which has led to the development of different forms of direct consumer access to laboratory testing commonly referred to as direct access testing (DAT). DAT is generally defined as consumer requested laboratory testing.2  DAT is known by a variety of other names including direct-to-consumer or patient-authorized testing.2  It is characterized by the consumer ordering the tests to be completed (or initiating the order) and paying up-front and out-of-pocket for the service. Healthcare insurance might not reimburse the consumer for this testing. Tests are usually ordered without clinician consultation and the consumer is responsible for any follow up with their clinician.3 The continued expansion of direct access testing (DAT) services has increased consumer access to personal electronic healthcare information and has entrusted consumers with greater control over their health and decision-making capability.

Offering DAT laboratory services places the medical laboratory professional in a direct service relationship with the consumer. DAT services may be offered within many settings.  Examples include:

  • Healthcare facilities such as clinics and hospitals
  • Independent reference laboratories and independent laboratory service centers
  • Over the counter (patient performed test kits), pharmacies, wellness programs, fitness centers, etc.
  • Internet/online programs (no face-to-face contact with the DAT service provider)
  • State or county health departments

Tests that are offered through DAT programs may vary depending on the type of laboratory performing the testing, how the testing specimen needs to be collected or transported to the testing laboratory, and what is outlined in current state law for the testing laboratory location.  The types of testing offered may range from very limited, routine screening tests to very specialized testing (e.g., genetic disease screening, comprehensive drug screening, etc.).

Rationale

The National Academy of Medicine (previously Institute of Medicine), in its 2001 publication “Crossing the Quality Chasm: A New Health System for the 21st Century”, suggested a redesign of the system which would include (a) the patient as the source of control, (b) unfettered access for patients to their own medical information and to clinical knowledge, and (c) evidence-based decision making.4

Television, print media, and the internet, have led to a more informed population of healthcare consumers who have access to a great deal of medical information. These consumers desire more involvement in their medical care and are willing to pay for the service.  They can freely research their health conditions on the internet and are informed consumers who: may not have a personal clinician but are willing to pay for extra assurance of their wellness or early signs of health problems, prefer to come armed with data when clinician office visits are required, and seek confirmatory data following a clinician visit.  In addition, patients with chronic health conditions may prefer to track their health status more frequently than their insurance coverage defines as medically necessary.

DAT Clinical Laboratory Considerations

Quality and Patient Safety Considerations:

DAT services should be clinically and analytically valid and the tests offered should be appropriate for use by a consumer without involvement of a healthcare clinican.5  DAT should also give direction to the consumer for when to appropriately involve a healthcare clinician to ensure safe care and follow-up. Therefore, DAT does pose several valid quality and patient safety aspects that must be considered when developing a DAT program, including:

  • appropriateness of test menu offered
  • appropriateness of tests ordered
  • reliable interpretation of test results
  • consumer reporting and follow up of results
  • generation of a false sense of security if test results are normal
  • undue concern if test results are outside of published normal ranges
  • mismanagement of critical or significant findings / results
  • disreputable marketing practices
  • ethics involving communication of genetic testing and reportable infectious diseases

There are ongoing concerns regarding consumers receiving credible laboratory testing information from DAT providers.  Consumers must receive appropriate information to ensure that they are knowledgeable on the following:

  • directions for patient preparation and specimen collection
  • clinical benefits and appropriate use of tests
  • changes to dietary, medications or health-related actions should not be implemented without involvement by their healthcare clinician
  • DAT should not be considered a substitute for traditional healthcare, including health screenings and visits to a healthcare clinician5

Business and Operational Considerations:

There are several key business areas that laboratories must establish prior to offering a DAT program.  Examples include:

  • specimen collection:

e.g., easy access locations, consumer friendly hours of service, patient preparation instructions, self-collection procedures (if applicable), access to interpreter services

  • test order and consumer consent process:

e.g., paper, electronic/online, smartphone app, consent to test/liability releases/informed consents, consumer responsibilities

  • payment process:

e.g., collection prior to service rendered, determine acceptable and unacceptable payment types (cash, card, personal checks, 3rd party payer billing), secure process to receive cash payments, accounts receivable process and record keeping

  • result reporting process:

e.g., paper, electronic (secure/encrypted email, online patient portal or electronic medical record access, etc.), verbal reports (allowed or not allowed)

  • test report content:

e.g., consumer friendly, written at 4th – 6th grade language level, includes complete interpretive information that can be easily understood, alternate languages, online resources available to assist with interpretation

  • critical/significant result handling:

e.g., reporting (written, verbal, electronic), documentation and recordkeeping to limit liability, follow up consumer communication (repeat/recollect test, be seen by their primary clinician, be referred to urgent care, etc.)

  • customer support and professional consultative resources:

e.g., available to answer consumer questions, resolve complaints, and provide appropriate printed or online resources to assist in understanding laboratory tests (easy access, hours of service, toll free phone number, published contact information, reputable online test interpretive resources, etc)

  • additional considerations:

e.g., state health department required reporting and consumer notification process (if applicable); program promotion/marketing (printed materials/social media/newspaper/website, etc.); education and engagement of medical staff (if applicable)

Legal and Regulatory Considerations:

Clinical laboratories should work with their facility’s risk management team and/or legal counsel to address legal/ethical concerns in offering a DAT program such as:

  • interpretation of state law regarding DAT (allowed or not stipulated, not allowed, allowed with testing limitations)
  • consumer liability release and/or informed consent
  • participation of minors (allowed or not allowed)
  • parents’ ability to order tests on minor children
  • communication of genetic testing results and availability of genetic counselling, if applicable
  • utilization of DTC (Direct-to-Consumer) 2.0 guidance when genetic testing6is offered
  • management of reportable infectious disease results

The CLIA regulations do not differentiate between facilities performing DAT and facilities performing clinician ordered testing.  All facilities that meet the definition of “laboratory” under CLIA must obtain an appropriate CLIA certificate prior to conducting patient testing, including DAT.  The CLIA certificate must be maintained and the required federal regulations must be followed throughout all phases of the total testing process. 2 One area of concern relates to DAT facilities that only hold a CLIA waived certificate.  The CLIA waived facility has minimal regulatory oversight and is not required to employ appropriately credentialed medical laboratory professionals to provide consumer clinical consultation and assistance with patient-specific interpretation of test results.7-8

Position Statements

  1. ASCLS supports the recommendation of the National Academy of Medicine pertaining to the consumer’s right to have unfettered access to their own medical information and to clinical knowledge in a manner which they can understand.
  2. ASCLS believes that certified medical laboratory professionals play a critical role in the development and oversight of a DAT program.
  3. ASCLS believes that all DAT should meet the same standards as clinician ordered testing, with demonstrated clinical validity and utility that is backed by scientific evidence.
  4. ASCLS believes that medical laboratory professionals have an ethical responsibility to ensure consumer information is accurate and the safety of the public is protected.9
  5. ASCLS believes that DAT laboratory services should be provided by certified medical laboratory professionals in CLIA certified clinical laboratories.
  6. ASCLS believes that it is the role of certified medical laboratory professionals to consult with consumers about the purpose of laboratory tests and the general interpretation of laboratory results.
  7. ASCLS supports appropriate reimbursement for clinical laboratory services in all settings when the service will improve patient safety, diagnosis, and patient outcome.

References

  1. Centers for Medicare & Medicaid Services. Provider compliance tips for laboratory tests-other (non-Medicare fee schedule). ICN 909407, 2018 Feb. Available from https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/ProviderComplianceTipsforLaboratoryTests-ICN909407-TextOnly.pdf
  2. Centers for Medicare & Medicaid Services [Internet]. Direct Access Testing (DAT) and the Clinical Laboratory Improvement Amendments (CLIA) Regulations [cited 2021 Jan 28]. Available from https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/directaccesstesting.pdf.
  3. Direct Access Testing from Concept to Reality. AACC/ASCLS Healthcare Forum; 2003 July 23; Philadelphia, PA.
  4. Institute of Medicine (US) Committee on Quality of Health Care in America. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington DC: National Academies Press; 2001. Doi: 10.17226/10027. Available from http://iom.edu/~/media/Files/Report%20Files/2001/Crossing-the-Quality-Chasm/Quality%20Chasm%202001%20%20report%20brief.pdf
  5. S. Food & Drug Administration [Internet]. Direct-to-Consumer Tests [current as of 2019 Dec 20; cited 2021 Jan 28]. Available from https://www.fda.gov/medical-devices/vitro-diagnostics/direct-consumer-tests
  6. Allyse MA, Robinson DH, Ferber MJ, Sharp RR. Direct-to-Consumer Testing 2.0: Emerging Models of Direct-to-Consumer Genetic Testing. Mayo Clin Proc. 2018 Jan:93(1):113-20. doi: 10.1016/j.mayocp.2017.11.001. PMID: 29304915. Available from https://pubmed.ncbi.nlm.nih.gov/29304915/
  7. Merlin, TL. Direct Access Testing- Introduction and Overview. Meeting Summary Report; Addendum I. Clinical Laboratory Improvement Advisory Committee; 2003 Mar 12; Atlanta, GA. Available from https://www.cdc.gov/cliac/docs/summary/cliac0303_summary.pdf and https://www.cdc.gov/cliac/docs/addenda/cliac0303/Merlin0303I.pdf
  8. Whalen, R. Direct Access Testing (DAT)- Clinical Laboratory Improvement Amendments (CLIA) Requirements. Meeting Summary Report; Addendum J. Clinical Laboratory Improvement Advisory Committee; 2003 Mar 12; Atlanta, GA. Available from https://www.cdc.gov/cliac/docs/summary/cliac0303_summary.pdf and https://www.cdc.gov/cliac/docs/addenda/cliac0303/Whalen0303J.pdf
  9. The American Society for Clinical Laboratory Science [Internet]. Code of Ethics. c2012- 2021 [cited 2021 Jan 29]. Available from https://www.ascls.org/about-us/code-of-ethics