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Advanced Diagnostic Laboratories Awarded CAP 15189SM Accreditation


The Advanced Diagnostic Laboratories (ADx) at National Jewish Health has been awarded accreditation in the CAP 15189SM Accreditation Program, administered by the College of American Pathologists (CAP), a Centers for Medicare and Medicaid Services (CMS).


The accreditation is based on Standard 15189 for laboratory technical competence and continual quality management, which is administered by the International Organization for Standardization (ISO). It seeks to improve patient safety and reduce risk, by outlining standards for quality and competence in medical laboratories. Fewer than 20 laboratories in the United States have been awarded the CAP 15189 Accreditation.

CAP 15189SM is a voluntary, non-regulatory accreditation to the ISO 15189:2007 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 optimizes processes to improve patient care and strengthens quality standards while reducing institutional errors and risks, and controls costs. CAP 15189 is an educational program that offers a highly disciplined approach to implementing and sustaining change.

“Although the 15189 Standard is not currently mandated in the US, the CAP believes laboratories that work towards its implementation have committed resources and ideals to a quality system focused on the needs of the patient,” said William Castellani, MD, FCAP, chair of the CAP 15189 Committee. “The College is proud to acknowledge those laboratories that have taken this system to heart and demonstrated that this dedication to quality is embraced throughout the facility.”

“We are so pleased to have been awarded this accreditation. Going through this process has helped us focus on our quality systems and optimize many processes to reduce errors and risk” said Ronald Harbeck, PhD, Medical Director for ADx Laboratories. Bob Tomb, Quality Manager for ADx added, “We discovered what we did not know or had not seen previously, and actions we can take to continuously improve our laboratory operations”.

About ADx at National Jewish Health

ADx provides both general and specialized testing for clients throughout the world, and operates within the extraordinary clinical and research environment of National Jewish Health and its renowned expertise in respiratory, immunologic, and related diseases.  The laboratories integrate academic, scientific and technical strengths to provide state-of-the-art clinical and research assays.

ADx offers laboratory testing services used by hospitals, commercial laboratories, physicians and public health agencies to assist with the diagnosis, treatment and management of difficult to treat diseases. Additionally, ADx provides testing for clinical trials that require complex and superior methods as part of the diagnostic testing protocol.

About the College of American Pathologists

The College of American Pathologists (CAP) is a medical society that serves more than 17,000 physician members and the laboratory community throughout the world. It is the world’s largest association composed exclusively of board-certified pathologists and is widely recognized as the leader in laboratory quality assurance. The CAP is an advocate for high quality and cost-effective patient care.

National Jewish Health is the leading respiratory hospital in the nation. Founded 125 years ago as a nonprofit hospital, National Jewish Health today is the only facility in the world dedicated exclusively to groundbreaking medical research and treatment of children and adults with respiratory, cardiac, immune and related disorders. Patients and families come to National Jewish Health from around the world to receive cutting-edge, comprehensive, coordinated care. To learn more, visit the media resources page.

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