ARUP Healthcare Advisory Services Can Help Labs Strengthen Quality Management as New FDA Regulations Loom

Laboratory quality management systems (QMSs) are under a spotlight due to requirements in the FDA's final rule regulating laboratory-developed tests (LDTs) as medical devices. The first deadlines under the new rule are fast approaching, but many clinical laboratories are unsure whether or how to move forward to implement the new requirements with the future of the FDA's rule in question.

Despite the uncertainty surrounding the new LDT rule, ARUP Healthcare Advisory Services can help laboratories prepare in two ways: first, with a comprehensive resource guide designed to help labs prepare to comply with the LDT rule; and second, with a custom gap assessment that can pinpoint opportunity areas within a lab's existing QMS.

"People are going to have to get on board and start preparing to comply with the rule," said Rick Panning, MBA, MLS(ASCP)^CM, ARUP senior healthcare consultant. "We're six months away from the first deadline. We can't just wait and hope it's going to go away."

The FDA is taking a staged approach to implement the new LDT regulations. The first stage, which goes into effect in May 2025, focuses on medical device reporting. It also encompasses some QMS requirements, including complaint files and corrections and removals reporting. Additional QMS requirements take effect in May 2027.

Panning advised laboratories to begin working toward compliance now, rather than waiting and hoping the LDT rule will be revoked. The College of American Pathologists (CAP) and other organizations representing clinical labs have encouraged the Trump Transition Team to recommend the incoming Donald Trump administration rescind the FDA's LDT rule. Additionally, a federal lawsuit challenging the FDA's authority to regulate LDTs is still pending. Panning said that litigation timelines suggest the lawsuit will not be settled before the May 2025 deadline to meet stage-one requirements.

Even if the FDA's LDT rule is ultimately rescinded, developing, refining, and improving a QMS should be an ongoing objective for every clinical laboratory.

"A QMS fosters a culture of quality and ensures the consistent delivery of accurate, reliable, and timely results, which are critical to patient care," said Ladonna Bradley, MT(ASCP), ARUP senior healthcare consultant. Other benefits of a robust QMS include increased operational efficiency and cost savings, risk management, staff engagement and skill development, customer trust, and market competitiveness.

The Clinical and Laboratory Standards Institute (CLSI) provides a structured approach to building a QMS with 12 quality system essentials (QSEs). Those 12 QSEs have been broadly implemented within the laboratory industry, said Panning. "But it's not everywhere. Many organizations have adopted some, but not all the QSEs, whereas others may have implemented them only in parts of their laboratory operations."

Laboratories that seek CAP accreditation should implement the 12 QSEs. "But the same standards don't necessarily apply for those that have accreditation from The Joint Commission or COLA [Commission on Office Laboratory Accreditation]," Bradley said.

For those organizations that want to strengthen their existing QMS or implement a new QMS, Healthcare Advisory Services offers assessments that can identify QMS gaps and provide a path for resolving them. ARUP's healthcare consultants can also help laboratories prepare for accreditation inspections and meet the requirements for certification from the International Organization for Standardization (ISO) 15189 standards.

"We use those 12 quality system essentials, and the elements within each of those, to perform a gap assessment and identify actionable insights for improvement. We can suggest targeted strategies to enhance their overall QMS performance and compliance," Bradley said. "We can provide clients with a clear understanding of their areas of deficiency and opportunities for improvement."

Healthcare Advisory Services consultants draw on the quality expertise of ARUP, which has achieved ISO 15189 certification for all its performing laboratories. Quality is a pillar of ARUP's culture, along with a commitment to continuous improvement.

A key aspect of continuous improvement is staying abreast of the ever-evolving regulatory environment. ARUP strives to stay ahead of anticipated changes so it can quickly adapt and help its clients adapt as well.

"We're always trying to do the right thing for our clients," Panning said. "We are here to help our clients become better laboratories."

Heather Stewart, [email protected]

Public link

Please use the above public link if you want to share this noodl on another website.