2006 Leadership Conference and Risk Management Workshop
Combine Industry, Government, and Healthcare Professionals from Diverse Nationalities with Networking Opportunities to Advance Quality in Healthcare Testing

Vienna, Virginia was lively from 26–29  April, 2006  with laboratorians, practitioners, industry executives, government officials, healthcare professionals and academics arriving from around the globe to participate in the Clinical and Laboratory Standards Institute’s 2006 Leadership Conference and "Risk Management Tools for Improved Patient Safety” workshop.

The event combined elements of a summit on the increasingly vital issue of improving patient safety and a celebration of the collaborative spirit that binds the Clinical and Laboratory Standards Institute’s 1,500-strong global volunteer pool. Participants came from around the globe including representatives from Tanzania, Germany, Trinidad, Ethiopia, Switzerland, Italy, Sweden and Canada.

For additional details or copies of presentations used in the Leadership Conference General Sessions or the Risk Management Workshop see details and links below.

2006 Clinical and Laboratory Standards Institute General Session Presentations

Creating a Culture of Patient Safety Through Risk Management:  This introductory presentation describes the fundamentals of risk management that is, "what is risk to us?" It provides an overview of the risk cascade and approaches to risk mitigation.

Patient Safety during an Emergency:  An emergency uniquely challenges healthcare operations and patient safety. This presentation provides a brief review of potential process defects spanning the emergency continuum of care, and their effects regarding patient safety. General preparedness recommendations are also provided.

Managing risk in the pre-analytical testing process:   Studies have shown that most errors in the laboratory testing process occur in the preanalytical portion of the testing cycle.  Major sources of error include order entry, patient and sample identification, and inadequate patient preparation.  This presentation will include data on the frequency of errors and possible approaches to reduce error to improve patient safety.

Managing risk in the analytical testing process:  This session considers the basic types (failure modes) or sources of error in the analytical testing process. Consideration is given to error detection approaches for each type of failure mode, and error prevention approaches.

Managing risk in the post-analytical testing process:  This presentation focuses on where risk is found in the post-analytical portion of the total testing process. Risk related to entry of data into the reporting system, post-analytical modification, notification, application of interpretive, report formatting, transmission of reports, provider awareness and provider action are considered.

Risk management – An international perspective:  This presentation looks at WHO and Joint Commission International initiatives as well as the ISO documents on risk management in medical laboratories The experience of five Italian laboratories - promoting a network of excellence- in the field of risk analysis is analyzed.

Risk Management Tools for Improved Patient Safety Workshop

Risk Management Tools for Improved Patient Safety was a special workshop sponsored by AACC, AdvaMed, ASCLS, ASCP, ASTM, CAP, CDC, CLMA, CMS, COLA, CSMLS, IFCC, IQLM, and CLSI in conjunction with the Leadership Conference. An unparalleled group of world-renowned laboratory, industry, and government leaders and luminaries joined forces to share their views on the topic of improving patient safety through risk management, providing hands-on tools, fielding attendee questions, encouraging dynamic discussion, and providing a multidimensional perspective.  Below is a summary of the topics and speakers.

Risks to Patients Created by Laboratory Testing Errors - D. Joe Boone, PhD, Centers for Disease Control and Prevention: This presentation demonstrates how the application of the tools risk management can help answer questions related to patient safety, while assisting in reducing laboratory testing errors.

Current Risk Management and the Medical Laboratory - Michael A. Noble, MD, FRCPC, University of British Columbia; This presentation describes the benefits of active internal audit, quality indicator, corrective action, preventive action, and “opportunity for improvement” programs to better position laboratories to be more risk aware. Examples of formal risk management procedures are considered.

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 explains the systematic risk management approach and explore how a clinical laboratory might implement a risk management program based on ISO 14971. In an ideal world, a clinical laboratory would leverage and complement the risk management processes of suppliers of in vitro diagnostic systems to foster patient safety.

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

Process Mapping and FMEA for Improved Patient Safety - A Case Study - Joan Carlson, MLT, BSc (MLS), University of Alberta: In this case study, Failure Modes and Effects Analysis (FMEA) is applied to a process flowchart of an automated laboratory analyzer. This case study will illustrate the use of FMEA by providing an overview of a process flowchart for an automated laboratory analyzer; showing an example of combination of FMEA and process mapping tools; and, describing how FMEA can be used in conjunction with a process flowchart to reduce error and harm.

Utilizing Failure Mode and Effect Analysis (FMEA) to Examine the Processes of Patient Identification and Specimen Labeling - A Case Study - Shirley Weber, MHI, MHA, MT(ASCP), University of Kansas: This case study describes 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.  Measures of effectiveness and conformance, outcome data, and lessons learned from this project are also included.

Alternative Quality Control Update - Judith A. Yost, MA, MT(ASCP), Centers for Medicare and Medicaid Services: This session provides an update on current activities related to the quest for alternative quality control solutions.

Training Sessions Presentations    

Process Mapping - Lucia M. Berte, MA, MT(ASCP), SBB, DLM; CQA(ASQ) CQMgr, LMB Consulting: A technique for preparing a workflow diagram that visualizes a work process or series of parallel processes. A process map shows the sequence and interrelationships of inputs — such as people, methods, machines, and materials — to achieve a given output. A properly prepared process map provides a clear picture of the activities needed to successfully complete the process, shows who is responsible for each activity, and identifies decisions to be made. The process map also identifies where instructions are needed for how to do each activity. Each activity can then be subjected to a risk analysis.

Failure Modes and Effects Analysis - Richard R. Miller, Jr., Dade Behring Inc.: A “bottom up” technique that examines how specific failures can affect a system or process.   It designed to identify potential failure modes, to estimate the consequences associated with each failure mode, and to identify actions to reduce unacceptable risks to an acceptable level.  An FMEA typically includes a method to evaluate the risk associated with the potential failure modes.

Fault Tree Analysis - Tina A. Krenc, Abbott Diagnostics: A “top down” method that starts by assuming a main system or process failure and analyzes what factors could cause it.  It more efficient than FMEA for analyzing combinations of failure events and human use errors.  FMEA and FTA are often used together for a complex system to ensure an efficient and comprehensive “top down” and “bottom up” risk analysis.

Hazard Analysis and Critical Control Point (HACCP) - Robert C. Menson, PhD, Menson & Associates, Inc.: A technique used to identify the steps in a process that require controls (called the “critical control points”), either because of their tendency to fail or because of the difficulty to detect failures that occur. HACCP builds on other risk analysis tools (e.g., FTA, FMEA) to enable risks to be estimated and controlled at each process step.

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