2016 Annual Meeting

SC02-Striving for Excellence: Leveraging CLIA Accreditation, ISO 15189 and Lean for Anatomic and Molecular Pathology Laboratories

Room CC 619-620, March 18 2016, 8:00am to 11:30am


SC02-Striving for Excellence: Leveraging CLIA Accreditation, ISO 15189 and Lean for Anatomic and Molecular Pathology Laboratories

Session Credits: 3 CME and 3 SAMs

Faculty: Richard J. Zarbo, MD, Henry Ford Health System, Detroit; Rita D'Angelo, MS, CAE, SSBB, DANGELO-ADVANTAGE, LLC; and Gaurav Sharma, MD, Henry Ford Health System, Detroit, MI

The oversight of today's modern, competitive anatomic and molecular laboratories demands leaders who have knowledge of effective laboratory management and quality improvement techniques that address regulatory, efficiency, financial and patient safety requirements. Successful leaders not only meet current accreditation standards but can exceed customer expectations by leveraging systems of work, like lean management, that optimize continuous improvement with daily management and problem solving. More recently, the option for hospital accreditation by the ISO-based DNV organization highlights further opportunities to integrate International Standards Organization (ISO) quality requirements focused on quality system essentials. Based on our practical experience in one of the United States' largest system of laboratories supporting an integrated healthcare delivery network, we will share the leadership, management, technologic and workforce requirements for effective implementation of a quality management system that leverages and integrates the aspects of CLIA accreditation, lean management and ISO 15189 accreditation.

This course is a didactic presentation with illustrative case study examples throughout and is intended for pathologists, pathologists-in-training and laboratory managers/administrators. No advance study materials will be available for registrants. Powerpoint presentation will be posted to the USCAP website after the meeting.

Upon completion of this course, the participant should be able to:

  1. Understand the role of Quality Management Systems (QMS) in enabling continuous learning, evolution and improvement of workforce culture and productivity through Lean manufacturing based production principles
  2. Distinguish the roles of the physician leaders, technical managers and team members in the design, application and sustainment of an effective QMS that can be implemented broadly across medical laboratory settings
  3. Understand the intersection of QMS requirements and standards for CLIA'88 and ISO 15189 accreditation
  4. Understand the process of ISO 15189 preparedness including commonly identified gaps and their resolutions.


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