ARUP Achieves Reaccreditation Under College of American Pathologists ISO 15189 Program

SALT LAKE CITY-ARUP Laboratories today announced that the College of American Pathologists (CAP), a Centers for Medicare and Medicaid Services (CMS)-approved accreditation authority, has awarded it reaccreditation under the CAP 15189^SM Accreditation Program.

The reaccreditation is based on the International Organization for Standardization (ISO) 15189 standard for laboratories' technical competence, management, and continual improvement. ARUP is the largest laboratory to achieve accreditation under the 2022 update to the standard, which places a heightened focus on improved patient safety and risk reduction.

"ARUP's accreditation to the ISO 15189:2022 standard ensures greater reliability, reduced risk, and stronger confidence across its expansive test menu, including many laboratory-developed tests (LDTs)," said CAP President Donald S. Karcher, MD, FCAP. "The CAP is pleased to recognize ARUP for meeting the high standards set in our accreditation program."

As one of the nation's largest and most complex reference laboratories, ARUP, with its extensive test menu, which includes numerous LDTs, demonstrates its commitment to quality and leadership in laboratory medicine through participation in the CAP 15189 Accreditation Program. By aligning with the ISO 15189:2022 standard, ARUP benefits from the standard's attention to risk management, operational resilience, and continuous improvement, validated by the CAP, the nation's largest and most rigorous laboratory accreditor.

"We value this reaccreditation because it affirms that ARUP has a robust quality management system [QMS] and continues to nurture a culture of continuous improvement that penetrates from the executive level to entry-level staff," ARUP Chief Quality Officer Margaret Coppin, HT(ASCP), said.

Assessors spent three days at ARUP, from August 12 to 14. They found no nonconformities with the 15189:2022 standard. In their report, they praised ARUP's technical excellence, commitment to quality, and distinctive workplace culture. They highlighted areas where they said ARUP demonstrated best-in-class practices, including:

• Contingency planning drills, which the assessors said showcased ARUP's business continuity readiness and foresight
• Integration of the warehouse into the QMS, which they recognized as a model of operational cohesion
• Innovative use of automation and artificial intelligence, which the assessors said streamlined lab operations and improved efficiency
• Rebuilding of the Huntsman Cancer Center grossing room and enhanced automation of the University of Utah Hospital lab, which ARUP manages in addition to serving as a national reference laboratory. The assessors said these improvements were completed in a manner that reflected a deep commitment to patients as well as the employees delivering their care.

"Perhaps most importantly, the assessors noted that our staff expressed genuine excitement to be part of an outstanding team," CEO Andy Theurer said. "We know that our greatest strength is our people. This is not just an accreditation, but a celebration of the identity we hold dear."

CAP 15189 is a voluntary, nonregulatory accreditation to the ISO 15189:2022 standard as published by ISO. The program does not replace the CAP's Clinical Laboratory Improvement Amendments (CLIA)-based Laboratory Accreditation Program, but complements CAP accreditation and other quality systems. The program emphasizes practices that encourage process optimization to improve patient care, strengthen quality standards while reducing institutional errors and risks, and control costs. CAP 15189 is an educational program that offers a highly disciplined approach to implementing and sustaining change.

"The ISO 15189 standard helps laboratories achieve a framework to continuously work on improving themselves," said Vipul Trivedi, MD, FCAP, chair of the CAP 15189 committee. "Through the use of risk assessment and process improvement, we are able to achieve the highest levels of laboratory care for patients."

For additional information on the CAP 15189 program, send an email to [email protected].

Read more about ARUP's accreditations and licensures here.

About ARUP Laboratories

Founded in 1984, ARUP Laboratories is a leading national reference laboratory and a nonprofit enterprise of the University of Utah Spencer Fox Eccles School of Medicine and its Department of Pathology. ARUP offers more than 3,000 tests and test combinations, ranging from routine screening tests to esoteric molecular and genetic assays. In addition, ARUP is a worldwide leader in innovative laboratory research and development, led by the efforts of the ARUP Institute for Research and Innovation in Diagnostic and Precision Medicine™. ARUP is ISO 15189 and CAP accredited. For more information, visit https://www.aruplab.com.

ARUP Media Contact

Lisa Carricaburu, [email protected]