Since Congress did not include new regulations for laboratory-developed tests (LDTs) in a year-end spending budget, it appears the Food and Drug Administration (FDA) will take steps of its own to increase the agency’s oversight of LDTs. “We are moving forward with rulemaking,” said Elizabeth Hillebrenner, Associate Director for Scientific and Regulatory Programs at the FDA’s Center for Devices and Radiological Health, at the American Clinical Laboratory Association’s annual meeting on March 1 in Washington, D.C. The news was reported by BioWorld. There is no timeline yet for the rulemaking, Hillebrenner said, according to BioWorld.
MORE ON: FDA LDT Oversight
The FDA had previously hinted that it would propose new LDT rules if congressional action—such as through the Verifying Accurate Leading-edge IVCT Development (VALID) Act—didn’t receive support. As of mid-2022, the VALID Act appeared to be on its way to passing in Congress before pathologists, particularly, at academic medical centers, publicly voiced opposition to the bill. The VALID Act was in play in Congress’ year-end spending bill in December but was cut from the final language of the legislation.
LAB PAYS $16,500 TO SETTLE ALLEGED HIPAA MISSTEPS
A recent settlement cost a clinical laboratory $16,500 in fines for allegedly not providing a timely response to a routine records request. On July 1, 2021, an individual asked Life Hope Labs in Sandy Springs, Georgia, to provide diagnostic records for her deceased father. However, she allegedly did not receive them until February 16, 2022. In addition to the monetary settlement with the Department of Health and Human Services Office of Civil Rights, Life Hope Labs also had to file a corrective action plan. Generally, HIPAA’s Privacy Rule requires labs to provide medical records within 30 days of a request by either the patient or a personal representative of the patient.
TRANSITIONS
• Karen Saldaña is the new Chief Operating Officer at lab IT consulting firm U.S. HealthTek in Haymarket, Virginia. Saldaña comes off a two-year stint at BioReference Laboratories and prior to that spent 20 years at Quest Diagnostics.
• Liron Pantanowitz, MBBCh, will return to the University of Pittsburgh School of Medicine as Chair of the Department of Pathology, effective May 1. He had a 10-year run at Pittsburgh before going to the University of Michigan. Pantanowitz is also President of the Digital Pathology Association.
