New QC Based on Risk Management: A Collaboration between CLIA and CLSI

Why Should You Attend:

Anyone overseeing Quality Control for a CLIA licensed laboratory should learn about the new QC option being implemented this year based on this collaboration between CLIA and CLSI. The document reviewed here provides a road map for “developing and maintaining a quality control plan (QCP)”, founded on the principles of risk management.

This presentation examines QC methods for collecting the essential data needed to conduct a risk assessment and, thus identify areas in processes that may reduce risk. These risk monitors are potentially failure points that may be reduced or eliminated. These QC measures are part of the Quality Management System’s Quality System Essential (QSE), Process Management, to continually improve your laboratory’s testing outcomes.

In addition, the presenter will also review the pros and cons of various tools outlined in the guideline.

Areas Covered in the Seminar:

• Developing this new QC Plan based on Risk Management.
• Where to collect data and information for quality monitors?
• Definition of Risk Management Principals.
• Review of the Lab environment and the clinical application of test results.
• How to use this data to detect trends, identify corrective actions, and promote CQI?
• Pros and cons of the various tools in the Guideline.

Who Will Benefit:

• Laboratory Directors and Managers
• Clinical Lab QC Personnel
• Pathologists
• Lab Compliance Officer or Committee

Instructor Profile:

Pam Tayon Colker, has a degree in Biology from Hollins University, Virginia, and her Medical Technology Internship from Mt. Sinai Medical Center, Miami Beach. She has two MBA's; Human Resources Management, from DePaul University, Chicago, and Information Systems Management, from the University of Tampa.

Pam is a licensed ASCP Medical Technologist and Florida Clinical Laboratory Supervisor with 20 years of managerial experience, with the majority in laboratory consulting, with Health Care Development Services and SCC, SoftComputer. She has also been a Laboratory Director at hospitals in the Chicagoland and Tampa Bay areas.

Pam is the Principal with TC Consult, Inc., a physician office laboratory consulting firm, and Medical Technologist at OneBlood, Inc., formerly Florida Blood Services. She has given breakout sessions at several Clinical Laboratory Management Association Meetings and written articles for CLMA, Advance for Administrators and the American Association of Family Practice.

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