Can you Order Lab Tests without Doctor?

Many people are uncomfortable talking with their doctors about ordering lab tests. Or someone wants to order lab tests without doctor due to privacy considerations. In addition, patients with chronic health conditions may prefer to track their health status more frequently than their health insurance plan defines as medically necessary. As there's a lot of information available online, including television, print media, and the internet, a more informed population of healthcare consumers want to have better access to their medical information and order online lab tests for convenience reasons.  So, it's easy for people to post-test results and asks for help interpreting what those results mean.

But is this a good idea?

First off, let's talk about the pros:

You don't have to wait in a doctor's office or worry about the time commitment involved in visiting your doctor. Moreover, you can order almost any lab test through a medical home testing kit and then analyze the results on your own schedule. 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”, already suggested giving people better control, access, and decision-making tools to individuals. In July 2021, the American Society for Clinical Laboratory Science-ASCLS published their position paper that supports this shift from the traditional model of physician control determining what screening, diagnostic or therapeutic monitoring laboratory tests to empowering consumers to take responsibility for their own healthcare.

This shift moves from doctor-driven focus to consumer-driven focus and the term direct access testing (DAT), also known as direct-to-consumer (DTC) or patient-authorized testing¹.

What is Direct Access Testing? 
Direct access testing refers to the process of taking a lab test without ever going to a doctor or lab first. In the traditional healthcare model, people have to visit their physician to get a prescription before the test, then go to the lab in person. Their sample (blood, urine, stool, saliva, breath etc.) is taken by a healthcare professional and sent to a lab for analysis. Results of these tests are reported to the clinician, who assumes responsibility for communicating the results to the patient and recommending a wellness or treatment plan. 

Offering DAT laboratory services places the medical laboratory professional in a direct service relationship with the consumer. Direct access testing skips this step entirely. DAT enables you to order the tests by yourself and pay up-front and out-of-pocket for the service. As discussed in the previous post, medical home testing kits are not always can be done at home. Some are rapid tests that will give your results within a few seconds to 30 minutes, and others are based on collecting your samples at home and shipping it to the lab for analysis, while others still require your in-person visit to collect your sample by a healthcare professional.  What is common to all these methods is your responsibility to initiate the order, pay it and get the results directly to you.

Who can offer direct-to-consumers lab testing?
Direct access testing services may be offered within many settings, including healthcare facilities such as clinics and hospitals, independent reference laboratories, independent laboratory service centres, online programs, pharmacies, wellness programs and even fitness centers. The key point is that the performing lab should have the appropriate accreditation and quality system by the Centers for Medicare & Medicaid Services (CMS) that regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). The CLIA regulations do not differentiate between labs performing DAT and labs performing prescribed testing.  All facilities that meet the definition of “laboratory” under CLIA must obtain an appropriate CLIA certificate prior to conducting patient testing.

Quality and Patient Safety Considerations
Lab providers and online programs should follow certain quality and patient safety in order to offer lab testing directly to individuals. 

• A clear testing menu should be offered, 
• various consents forms, e.g., paper, electronic/online, smartphone app, etc. 
• Pre-test preparation instructions, self-collection procedures, easy access locations for tests that require an in-person visit, consumer-friendly hours of service, patient
• 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, and
• available to answer questions, resolve complaints,

Things You Should Know Before You Order Lab Tests without Doctor
Although DAT services should be clinically and analytically valid, and service quality and patient safety should be at the highest standard, not all lab providers and tests are equal.
If you’re planning to order a lab test without a doctor, here are some things to consider:

• Check if the service is offered in your state
• Verify the lab is accredited by CLIA and if there are limitations in your state.
• Compare lab test prices
• Check the payment methods and if your selected test can be paid by your HSA/FSA
• Understand if this is a rapid test, collected at home or requires an in-person visit
• Make sure you understand what analytes are included. Some tests may have the same name but include different parameters. For example, a women's ‘hormone test’ can include different hormones through different labs.
• See the turnaround time, e.g., when you would get the test kits at home and how long it would take to get the results back
• Request a test result template and see you understand the way your test will be reported to you
• Consider contacting your doctor if you are not sure you can take this responsibility alone
• Follow up with a healthcare professional to 

Conclusion
Ordering lab tests without your doctor can be a great way to control your health and save money. Tests that are offered online via multiple DAT programs vary depending on the type of laboratory performing the testing, how the sample needs to be collected or transported to the lab for analysis, and what is outlined in current state law for the testing laboratory location.  The types of testing offered may range from very few routine screening tests to very specialized tests like genetic disease screening or even therapeutics monitoring.  Consult with a healthcare professional to avoid a false sense of security if test results are a normal or unnecessary concern if results are positive or outside the normal range. Controlling your healthcare is not only ordering lab tests online but also understanding the results, changing your lifestyle if necessary, or seeking the appropriate treatment.

Can you Order Lab Tests without Doctor? 

1.    Direct Access Testing (DAT) and the Clinical Laboratory Improvement Amendments (CLIA) Regulations.