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Andrea Pitkus, PhD, MLS(ASCP)CM  Laboratory Informaticist

In researching different consume based testing for my recent ASCLS presentation at the Annual meeting, I found testing in the following categories:

1. Consumer purchased test kits that involve consumer collection of specimens which are sent to a CLIA laboratory for analysis with results reported to the consumer via email, an app or phone call. Examples may include urine drug screens, genetic testing such as 23 and me, and models like EverlyWell, My Lab Box, Let's Get Checked. In some of these cases, kits can be purchased in a local pharmacy or store, while in others, they are purchased online and shipped to the consumer.

2. Patient purchased kit or device used for patient performed testing whereby the patient collects the specimen, performs testing and interpretation is provided by the patient, a device or an app. Examples include: Athelas CBC, Dip.io home urinalysis dipstick testing, Alivecor personal EKGs, and Apple Watch's EKG/Potassium testing.

Articles highlight convenience and use by consumers in this emerging market of new testing paradigms. More importantly to the laboratory profession are the risks of such testing.

1. Patients may perform testing and self diagnose using these methods and avoid visiting their physician and thus not have laboratory performed testing performed. Patients may misdiagnose themselves as the illness worsens, which may result in increased costs with a worse condition.

2. Reduction in lab orders may result in decreased revenue to laboratories, negatively impacting business.

3. Increased risk of incorrect information from an informatics perspective. Health professionals are not collecting information, performing testing, ensuring quality of information recorded, etc., but rather the consumer. Consumers may not note details, follow instructions completely, etc. Parent and child results may be comingled on same account, app, email, etc. All have higher risk of error and potential patient harm depending in action/inaction taken. Clinical decision making is now consumer decision making.

4. How are consumer testing and Patient Generated Health Data (PGHD)integrated and used within the medical record. Some apps allow upload to the physician's EHR. They should not be comingled with laboratory performed testing as they are different. The largest issue is one of trust. Does the physician trust from a medical and legal perspective, results performed by consumers (who may have invalidated the home pregnancy test when dropped in the toilet) versus health professional performed testing? How are results kept separate in EHR modules and clinical displays? These new methods and perhaps specimens or transcutaneous analysis should have different LOINC codes so all users can identify these differences in health data.

5. Development of these technologies, especially apps is skyrocketing as this market rapidly grows. It'll be pushed by ONC's latest NPRM which closed in June whereby the next round of interoperability requirements requires FHIR apps to be used for data exchange. Details and dates of implementation to be specified in the final rule.

Risk to laboratories is many of these apps are developed by IT teams in start ups and even in health care consumer teams that often lack lab expertise and the performing lab is not notified. Many CLIA data elements provided by laboratories in the laboratory report of record are missing as an app may pull incomplete data from the EHR. In some instances data from multiple different labs or devices may be comingled in a table or graph and lack reference ranges for each (and consumer testing may not even have reference ranges!).

In other cases, with PGHD on devices, developers are creating their own naming for the values produced (as they aren't traditional lab results but those produced with new devices/paradigms, etc.) Health professionals may not know enough about these new results to understand how they relate to traditional methods. Impacts to clinical decision making may ensue.

There's so much more to comment upon, but these are the major concerns.

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