Creating a Culture of Patient Safety Through Risk Management
2006 CLSI Leadership Conference and Risk Management Tools for Improved Patient Safety Workshop

At the 2006 Clinical and Laboratory Standards Institute (CLSI) Leadership Conference, taking place 26-28 April in Vienna, Virginia, the spotlight is on patient safety through risk management. The goal to eliminate errors, manage risk, and achieve efficiency in healthcare testing is as pressing as ever—which means that the need to both deliver the right implementation strategies and to manage and optimize risk management processes has taken on an increased urgency.

Whether participants are defining or improving their risk management strategies, the 2006 CLSI Leadership Conference & Workshop offers a carefully crafted program of take-home strategies, practices, and solutions that will help attendees transform insight into action and capitalize on opportunities to improve patient safety.

Core CLSI Strategic Initiatives, Meetings, and Networking Events Highlight 2006 CLSI Leadership Conference

The 2006 CLSI Leadership Conference features an integrated line-up of meetings, including: CLSI Board of Directors, Board of Directors’ Committees, CLSI area committees and subcommittees. CLSI area committees, made up of leading experts from professions, government, and industry, will meet to review the status of current projects, establish priorities for 2006-2007, and resolve outstanding issues in project development. In addition, subcommittee sessions will be held to collaborate, interact, and complete work on existing projects in development.

On Thursday, 27 April at noon, a special Member/Volunteer Appreciation Luncheon will provide an opportunity to acknowledge the outstanding and important contributions of CLSI members and volunteers, install new directors, and recognize 2006 award recipients.

The 2006 CLSI awards program celebrates the achievements of volunteers who contribute to development of CLSI documents and products. Highlights of this year’s program include: Service Recognition, John V. Bergen Award, Honor Awards, and the Eilers Award. Service Recognition awards are given to CLSI volunteers who have completed terms of office or project leadership. The annual John V. Bergen Award recognizes the volunteer or group who advances CLSI organizational directives and objectives through unique and significant contributions. Based on the results of a nomination and review process with a selection of categories including Excellence in Standards Development, Consensus Management, Global Leadership, Mentoring, and Member Organization Leadership, newly established Honor Awards will be bestowed at the conference. In addition, the prestigious Russell J. Eilers Memorial Award will be presented to an individual who has made an outstanding contribution to voluntary consensus.

The President's Reception on Thursday, 27 April, hosted by Robert L. Habig, PhD, CLSI President-Elect, will offer unlimited networking opportunities, including one-on-one discussions with CLSI members and volunteers.

CLSI Leadership Conference participant Mary Burritt, PhD, Laboratory Director, Professor of Laboratory Medicine, Mayo Clinic explains, “The CLSI Leadership Conference is the only event in the healthcare community where industry, government, and laboratory professionals have the opportunity to collaborate as a group on solutions, as well as develop new professional relationships and even partnerships.”

Practical, Targeted Training Workshop Addresses Tools for Risk Management 

An added benefit to this year’s annual program is the strategic, one-day Risk Management Tools for Improved Patient Safety Workshop that provides the latest industry intelligence on the areas that matter most, including: trends and directions, strategies, alternative quality control updates, proper patient identification and specimen labeling, process mapping, Failure Mode and Effects Analysis [FME(C)A], fault tree analysis, Hazard Analysis and Critical Control Points [HACCP], and other key developments across the risk management spectrum.

This forum is a must-attend for clinicians, laboratorians, manufacturers, and government representatives from around the world who are interested in implementing a process to identify the hazards associated with their areas of specialty, to estimate and evaluate the resulting risks, to control these risks, and to monitor the effectiveness of that control in their home institutions.

“Bringing the risk management industry leaders together in one location enables unprecedented collaboration to define the current problems in risk management, and to discover tools to manage error and eliminate risk for improved patient safety,” explains Jennifer McGeary, MT(ASCP), MSHA, CLSI Director, Standards and Quality. McGeary adds, “In this practical forum, attendees can share the impact that risk management has had on their organizations, and can hear about the new opportunities that lay ahead.”

Attendees will hear about the latest initiatives and lessons learned from organizations that are leading the pack in deploying and integrating risk management technologies and processes. At the workshop, participants will learn how to:

• Reduce and eliminate errors and manage risk in healthcare settings
• Leverage the ISO risk management process used by in vitro diagnostics (IVD) manufacturers to foster patient safety
• Explain the benefits of extending the ISO process to laboratories
• List and describe currently available risk management tools, including process mapping, FME(C)A, fault tree analysis, and HACCP
• Demonstrate two risk management techniques and describe methods for their implementation

 “The primary thread of the workshop is to share and network with others to address a multitude of issues for implementing risk management activities,” McGeary explains. “The program provides a unique opportunity for everyone to absorb the latest knowledge, hear case studies of the actual use of the risk management tools, experience the benefits of targeted, hands-on training and peer discussion, and leave with resources for practical application in the workplace. Plus, this program fits right in with the implementation of a strong Quality Management System. It makes perfect sense to apply these risk management tools to ensure consistent practices and provide the highest level of patient care.”

According to workshop speaker Don Powers, PhD, President, Powers Consulting Services, “The value of a systematic risk management process in reducing the occurrence of harmful analytical errors has been well demonstrated. Other errors that affect patient safety could also be reduced or eliminated if the risk management approach described in ISO 14971 were extended to the clinical labs’ operations. The CLSI workshop will introduce the risk management tools needed to implement ISO 14971.”

The core of the Risk Management Tools for Improved Patient Safety program includes:

Opening Plenary  
Mary Burritt, PhD, Mayo Clinic
Moderator

Risks to Patients Created by Laboratory Testing Errors
D. Joe Boone, PhD, Centers for Disease Control and Prevention
How often do laboratory testing mistakes occur? Do they cause patient harm? Where during the testing process are they most likely to occur? How can they be prevented? This presentation will demonstrate how the application of the risk management tools could help answer these important questions, while helping reduce laboratory testing errors.

Current Risk Management and the Medical Laboratory
Michael A. Noble, MD, FRCPC, University of British Columbia
This session describes how laboratories that have implemented quality systems are equipped with some of the tools for addressing risk. Those with active internal audit, quality indicator, corrective action, preventive action, and “opportunity for improvement” programs are better positioned to be more risk-aware, and can develop risk management strategies.

An Industry–Laboratory Partnership to Minimize Patient Risks: Extending the ISO risk management process to the clinical laboratory
Donald M. Powers, PhD, Powers Consulting
This presentation will explain the systematic risk management approach and explore how a clinical laboratory might implement a risk management program based on ISO 14971.

Risk Management Toolbox: Risk Assessment Techniques for Clinical Laboratory Processes
Tina Krenc, Abbott Diagnostics
The major objective of this presentation is to supply the participants with a solid understanding of the available risk management tools, their strengths and weaknesses, as well as an overview of their use.

Alternative Quality Control Update
Judith A. Yost, MA, MT(ASCP), Centers for Medicare and Medicaid Services

Application of Risk Management Tools – Case Studies
Specific risk management tools will be illustrated through case studies, including:

Process Mapping and FMEA for Improved Patient Safety
Joan Carlson, MLT, BSc(MLS)
This case study will illustrate Failure Modes and Effects Analysis (FMEA) applied to a process flowchart of an automated laboratory analyzer. The overall effect of using FMEA with a process flowchart results in the ability to systematically detect potential errors and ultimately reduce harm to patients.

Utilizing Failure Mode and Effect Analysis (FMEA) to Examine the Processes of Patient Identification and Specimen Labeling
Shirley Weber, MHI, MHA, MT(ASCP)
In this case study, participants will learn what the FMEA process is and what it is designed to accomplish, how a multidisciplinary team examined a complex process, and how systems were designed to minimize risk and ensure patient safety.

Summary and Q&A
Mary Burritt, PhD, Mayo Clinic
Moderator

Training Sessions
Targeted, concurrent afternoon training sessions will allow participants to choose their most relevant areas of interest. Participants will choose two afternoon training sessions from the following topics:

Process Mapping
Lucia M. Berte, MA, MT(ASCP), SBB, DLM; CQA(ASQ)CQMgr, LMB Consulting
Process Mapping is a technique for preparing a workflow diagram that visualizes a work process or series of parallel processes, and can then be subjected to a risk analysis.

Failure Modes and Effects Analysis
Richard R. Miller, Jr., Dade Behring Inc.
Failure Modes and Effects Analysis (FMEAs) is a process for identifying potential errors and/or failures, and determining their potential consequences and the level of risk involved with these potential failures. The training session will consist of a brief review of the application the FMEA process, overview of the current literature and resources available to the healthcare industry, and a “live” example of conducting a FMEA.

Fault Tree Analysis
Tina A. Krenc, Abbott Diagnostics
The major objective of this session is to give the participants a working knowledge of fault tree analysis (FTA) through practice and peer discussion.

Hazard Analysis and Critical Control Point (HACCP)
Robert C. Menson, PhD, Menson & Associates, Inc.
Hazard Analysis and Critical Control Point (HACCP) is a structured approach that applies technical and scientific principles to analyze, evaluate, prevent, and control the risk or adverse consequence(s) of hazard(s), and to determine corrective actions if the hazardous situation does occur. At this session, attendees will learn the seven basic steps of HACCP, understand where to find references, and participate in an HACCP example.

Closing Plenary
Richard R. Miller, Jr., Dade Behring Inc.

Read the complete workshop agenda.

This workshop is approved by the American Association for Clinical Chemistry (AACC) for 7.5 AMA PRA Category 1 Credits™ and  7.5 ACCENT© credit hours towards the AACC Clinical Chemist’s Recognition Award.  In addition, eligible attendees may apply for 8.0 PACE®-approved continuing education contact hours. For more information regarding continuing education, visit www.clsi.org.

Unparalleled Support for the Risk Management Tools for Improved Patient Safety Workshop

There is unprecedented support from leading professional associations in the healthcare industry that are rallying behind the workshop. Workshop sponsors include: AACC, AdvaMed, AMP, ASCLS, ASCP, ASTM, CAP, CDC, CLMA, CMS, COLA, CSMLS, IFCC, IQLM.
 
"The sponsors represent the diverse range of organizations committed to the workshop’s success," says McGeary. She adds, “The overwhelming support we’ve received from so many leading, well-respected organizations underscores what we believe: The healthcare industry is primed for a conference that directly addresses the latest risk management techniques, technology, and trends that ultimately work to improve patient safety.”

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