In this session, we will discuss the final updates to the CMS CLIA 88 regulations that went into effect on December 26, 2024. We’ll focus on those that are specific to Technical Consultants and their role in training and in performing competency assessment for non-laboratorian testing personnel. We’ll include suggestions of things to consider when assessing the state of your current practice in order to meet the new CMS CLIA 88 changes.

An increasing number of wearable medical devices are being used for personal monitoring and professional healthcare purposes. Mobile health devices collect a variety of biometric and health data but do not routinely connect to a patient's electronic health record for access by a patient's healthcare team. The IFCC Committee on Mobile Health and Bioengineering in Laboratory Medicine developed consensus recommendations when interfacing mobile health devices to an EHR.

FDA has started to receive increasing number of medical device submissions that use microfluidics technology with 80% of these devices being in vitro diagnostic in nature. To cater to this emerging area, the Microfluidic Devices Program was created. The talk will first introduce FDA/Center for Device and Radiological Health’s Microfluidic Devices Program. Then it will discuss what barriers to medical device development have been identified in the microfluidic device space. Lastly, it will share the regulatory science tools that are being developed to overcome the barriers to innovation.

Phronetik’s mobile diagnostic labs bring advanced genomic testing and real-time data analysis directly to underserved and rural communities, addressing healthcare access disparities. Equipped with iHarmony-Seq for rapid sequencing and iConcordia for secure data integration, these labs enhance diversity in clinical research, improve patient engagement, and accelerate clinical trial timelines. By enabling early disease detection and timely interventions, Phronetik’s mobile model strengthens healthcare systems, advances precision medicine, and promotes equitable health outcomes through innovative, community-centered solutions.

Lab-in-a-Box (LIAB)—diagnostics designed to provide access, convenience, and knowledge to both doctors and patients in just 60 minutes. No send-outs for commonly order tests, no additional blood draw visit, optimized sample utilization; plus the doctor is paid for the tests and reviews the results with the patient during the visit. And, the patient leaves knowing what’s next!

Perspectives to be discussed:

• LIAB for Patients
• LIAB for Doctors
• LIAB for Retail
• LIAB for OEMs
• LIAB for Investors
  

Wearable devices measuring biometrics have the opportunity to support caregivers with more representative baselines and supplement time point-based diagnostics through the wealth of personalized, real-time data they generate. How manufacturers navigate the challenges of generating clinically relevant and reproducible data while supporting caregivers with the analytical tools necessary to process and manage this information will dictate the future position of wearables as a supplement to clinical diagnostics.

Remote specimen collection with samples sent to a central laboratory “Home to Lab” as well as at home testing options have shifted the paradigm in the patient journey. The goal of this talk is explore what is needed to support the changing paradigm and reduce barriers for diagnostic testing.

Objectives:

• Discuss when it makes sense to test at home vs. collect at home
• Examine hurdles to expanding these alternative strategies            
• Highlight key points of consideration for manufacturers who want to bring solutions to market
  

COVID overturned the way we think about testing for infections; moving patient expectations from "I’ll call my doctor and they’ll tell me if I’m sick enough to come in and get looked at" to "I’ve got this test in my bathroom, let’s see what’s wrong." But different tests perform differently—and an understanding of test performance is essential to using these tests to improve patient care and safety in all the settings POCTs are used—to answer the wide variety of clinical questions they're used to answer.  

Diagnostic stewardship is about offering the right test to the right patient so there can be the best medical impact. The appropriate test can vary depending on symptoms, the patient, and what is circulating.  This lecture will cover preanalytical and postanalytical considerations for respiratory testing in relation to guidelines.

• What current workflow is in place in your program, and are there aspects in place that will help you meet the new regulations?
• How do I review a transcript to determine if my 4-year RN meets the requirements to fill the TC role?
• Are you already seeing an impact on your Training and Competency workflow in your program?
• Will these new regulations help us hire more full-time employees in our POCT programs?​