Seventeen organizations don't support the Diagnostic Accuracy and Innovation Act as written and would like lawmakers to advance a CLIA-centric framework.
The list of regulated analytes needs to be reviewed and updated so that external quality controls are in place to protect patients, proficiency testing providers said.
According to the firm's CEO, there's a need for a portable hemoglobin measurement system that can deliver lab-quality results in the clinic within seconds.
Industry groups representing lab personnel strongly oppose CLIA's current practice of allowing personnel with nursing degrees to perform moderate- and high-complexity testing.
