ARUP Healthcare Advisory Services stands ready to help clients navigate the requirements that must be met to comply with the FDA’s final rule on LDTs. ARUP’s consultants have compiled a rich set of tools, resources, and templates to help clients get started on the steps necessary during the first two stages of the rule’s five-stage timeline.

“We have a sense that a lot of clients have questions, and we want to help as many as possible,” said David Shiembob, MBA, C(ASCP)^CM, manager, ARUP Healthcare Advisory Services. “That’s why we’ve taken this approach to providing information and guidance.”

The LDT guidance created by Healthcare Advisory Services covers:

• Health system and hospital responsibilities
• Requirements for the first two stages
• Quality management system requirements and best practices
• Action steps
• Additional resources

“There’s still some uncertainty, and we know change and additional FDA guidance are coming,” said Rick Panning, MBA, MLS(ASCP)^CM, ARUP senior healthcare consultant. “But we’re trying to provide guidance and direction to clients about the steps they need to be taking right now. We’re already several months into the first implementation phase, so no one should sit back and wait.”

Healthcare Advisory Services is uniquely positioned to help health systems and laboratories contend with the final FDA rule on LDTs, Shiembob said. “ARUP is navigating these issues along with our clients. We have a robust menu of laboratory-developed tests that we intend to continue offering in an FDA-compliant manner.”

Additionally, ARUP is committed to helping clients maintain their laboratories and test menus. “We believe in partnership with our clients, and we want our clients to be able to keep testing close to the patient when appropriate,” Shiembob said.

Request LDT resources from Healthcare Advisory Services.