www.aacc.org/2006am

Thursday, July 27, 2006

Making Sense of the Alphabet Soup of Laboratory Regulations 35103
Moderator: Linnea Baudhuin, PhD, Mayo Clinic, Rochester, MN
Level: Basic
CE Credit: 2.5

Developed in cooperation with Society for Young Clinical Laboratorians
Session Overview: This symposium will focus on the federal regulation of
laboratory testing principally through the Clinical Laboratory Improvement
Amendments of 1988 (CLIA 88) regulations. Additional topics to be discussed
include how the Joint Commission on the Accreditation of Health
Organizations (JCAHO) standards impact the clinical laboratory as well as
how the laboratory accreditation program of the College of American
Pathologists (CAP) contributes to ensuring the quality of laboratory
services.

Expected Outcomes: After attending this session, participants will be able
to: 1) describe the regulatory steps involved in establishing a new testing
site; 2) describe the latest requirements for CLIA '88 compliance; 3)
describe the evolution and relationship of the significant regulatory and
accreditation agencies; and 4) explain the mission and purpose of the CAP
Laboratory Accreditation Program.

SPEAKERS
JCAHO - Explained and Understood
Megan Sawchuk, Joint Commission on Accreditation,
Oakbrook Terrace, IL
CAP Laboratory Accreditation Program
Nancy Yeransian, MT, (ASCP)SC, College of American
Pathologists, Northfield, IL
CLIA 2006 Update: The Latest!
Sharon Ehrmeyer, PhD, Univ. of Wisconsin, Madison
A New Level of Quality Management in Clinical

Laboratories Through ISO Standards, LEAN Principles and Design for Six Sigma
35104
Moderator: James Love, Jr., PhD, DABCC, JL Consulting Services,
Penfield, NY
Level: Basic
CE Credit: 2.5
Developed in cooperation with the Industry and Management Sciences Divisions
Session Overview: This symposium will explore the value in integrating ISO
15189-based accreditation and ISO 9001:2000 certification to assure optimal
effectiveness of a laboratory's quality management system. This session will
also focus on the use of these ISO standards in conjunction with that of
LEAN and Design for Six Sigma techniques for development of new processes
and systems which can help laboratorians further enhance the quality and
effectiveness of
test results.

Expected Outcomes: After attending this session, participants will be able
to: 1) describe how to use a step-by-step approach to implement ISO
Standards; 2) identify the gains of successfully implementing an ISO-based
quality management system; 3) list the 7 categories of waste according to
LEAN theory; 4) cite 3 key non-negotiable principles of LEAN that should be
utilized when building criteria for making new process and equipment
decisions; 5) describe how to apply
the 4-step Design for Six Sigma (DFSS) process; and 6) determine whether
DMAIIC or DFSS will be the more appropriate process improvement technique to
use in their laboratory setting.

SPEAKERS
ISO 15189 and ISO 9001 in the Clinical Laboratory: A New Quality Management
System Approach.
Rogerio Rabelo, MD, PhD, MBA, Fleury Diagnostics,
São Paulo, Brazil
Where Do We Go From LEAN?
Maureen Harte, MT (ASCP), Six Sigma Master Black Belt,
Ortho-Clinical Diagnostics, Salt Lake City, UT
New Approaches in Six Sigma for the Clinical Laboratory.
Carl Garber, PhD, Quest Diagnostics, Incorporated, Lyndhurst, NJ