Clinical and Laboratory Standards Institute (CLSI), a CLMA Partner, is scheduled to present a series of educational sessions focused on compliance, quality management, patient safety, occurrence management, proficiency testing, and quality laboratory specimens at the CLMA ThinkLab ’07 Conference taking place 24-27 March in Houston, Texas USA.

Jennifer McGeary, MT(ASCP), MSHA, CLSI Director, Standards and Quality, explains, “CLMA ThinkLab ‘07 provides leadership in the clinical laboratory industry, affords supporting laboratory professionals an opportunity to talk about the evolution of their profession, and focuses on career development and professional growth. We are excited to put together the CLSI educational track. Attendees will be able to get in touch with the insight and experience from experts, and learn about the practical application and “how-to” techniques from CLSI’s standards and guidelines.”  

CLSI EduTrack sessions include:

25 March 2007 • 2:45 p.m. - 5:45 p.m.

Laboratory Documents: Development and Control
Lucia M. Berte, MA, MT(ASCP) SBB, DLM; CQA(ASQ)CQMgr.
 
The laboratory needs to provide carefully documented instructions—in the form of procedures—for all activities that support the performance of laboratory examinations. These instructions provide essential information for both new and experienced employees about how to perform their job, including nonexamination tasks, such as collecting blood samples and using the laboratory's computer system. The document management process is vital for ensuring that staff access and use only the most current versions of documents, and that everyone is following the same process sequence and procedure instructions. In so doing, performance variations that can affect the quality of laboratory services and results are greatly reduced or actually eliminated.

Learning Objectives:
Upon completion of the session, attendees will be able to:

• identify laboratory procedures using work processes in the laboratory’s operational path of workflow;
• describe an approach to writing procedures for preexamination, examination, and postexamination laboratory activities; and
• explain how CLSI guideline GP2-A5 can be useful in preparing, approving, maintaining, reviewing, revising, and archiving laboratory documents.

Features CLSI document: GP2-A5–Laboratory Documents: Development and Control; Approved Guideline–Fifth Edition* 

26 March 2007 • 8:30 a.m. - 9:45 a.m.

Ensuring Quality Laboratory Specimens 
Dennis J. Ernst, MT(ASCP), Center for Phlebotomy Education

Making sure specimen collection procedure manuals reflect the current CLSI standards and OSHA guidelines requires extensive research and document revision. However, failure of procedure manuals to reflect the prevailing standards is a major liability for the clinical laboratory. This presentation highlights the key components of CLSI documents and OSHA guidelines that must be reflected in every specimen collection and processing manual in order to manage the risk of patient injury, liability, and OSHA citations. The presenter will draw upon his experience participating in several CLSI working groups that revise specimen collection standards; developing CLSI- and OSHA-compliant educational resources; and serving as an expert witness in phlebotomy-related lawsuits.

Dennis J. Ernst, MT(ASCP), Center for Phlebotomy Education, Inc. encourages participants to attend the session, saying, “As an expert witness in legal cases involving specimen collection, the CLSI standards play a major role in establishing the standard of care. Woe to those whose procedure manual does not reflect them, and whose employees do not ascribe to them.”

Learning Objectives:
Attendees will understand how to:

• revise specimen collection procedure manuals to reflect current CLSI standards and OSHA guidelines;
• implement revised procedures that lead specimen collection personnel to perform procedures according to the standard of care; and
• modify procedures to protect patients and specimen collection personnel from injury while obtaining high-quality specimens for clinical testing.

Features CLSI documents: H3-A5–Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; Approved Standard—Fifth Edition, H18-A3–Procedures for the Handling and Processing of Blood Specimens; Approved Guideline—Third Edition, and H21-A4–Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays; Approved Guideline—Fourth Edition

26 March 2007 • 2:45 p.m. - 5:45 p.m.

Managing Nonconforming Events
Lucia M. Berte, MA, MT(ASCP) SBB, DLM; CQA(ASQ)CQMgr.

Occurrence management programs capture and analyze information from nonconforming events to identify systematic problems and gain management's commitment to removing the cause. Occurrence management is linked to the healthcare organization's risk management program, because it provides information on systematic service problems that could pose legal or financial risk issues. Each organization needs to have a process for detecting and documenting occurrences (nonconformances), classifying them for analysis, and correcting the problems they represent. Identifying, investigating, and classifying occurrences early in the quality management system's implementation leads to rapid identification of what it lacks, such as a documented process, procedure, or instructions. It also reveals documented processes or procedures that are not being followed and which work operations processes are problematic.

Learning Objectives:
At the conclusion of these sessions, participants will be able to:

• define remedial action and describe a process for documenting remedial action activities;
• list activities involved in investigating nonconforming events;
• describe tools used in the investigation of nonconforming events;
• explain methods for classifying and logging nonconforming events; and
• describe means of analyzing event information and for data presentation.

Features CLSI document: GP32-P–Management of Nonconforming Laboratory Events; Proposed Guideline - Available April 2007* 

26 March 2007 • 4:15 p.m. to 5:45 p.m.

Using Proficiency Testing to Improve the Clinical Laboratory
Jennifer Schiffgens, MBA, MT(ASCP), Director, Laboratory and Pathology, California Pacific Medical Center
Daniel W. Tholen, MS, A2LA

Proficiency testing (PT) is a valuable tool in the quality improvement process, because it evaluates a laboratory's performance compared to that of its peers and/or reference laboratories. PT is used not only for analytes measured quantitatively but also for procedures with qualitative results, and is not limited to investigating unacceptable results. Monitoring acceptable and unacceptable PT results allows the laboratory to identify potential, as yet asymptomatic problems related to imprecision, as well as to systematic and human error. Using CLSI guideline GP27 (Using Proficiency Testing to Improve the Clinical Laboratory) as a foundation for discussion, participants will be guided through selecting a PT program, monitoring qualitative and quantitative PT performance, and evaluating method performance using summary statistics. The root-cause investigation of unacceptable PT results and using proficiency testing as an educational tool will also be addressed. Laboratory managers and staff will learn about tools available for self-improvement, how to incorporate them into their quality management system, and how they can help satisfy accreditation requirements.

Learning Objectives:
At the conclusion of these sessions, participants will be able to:

• describe the use of proficiency testing as a quality improvement tool;
• describe a systematic approach to monitoring PT results;
• list benefits and limitations of proficiency testing programs;
• describe methods for investigating and responding to unacceptable PT results, including a classification of the types of problems that cause PT failures; and
• explain how to use PT as a tool to prevent problems through analysis of acceptable results, education of laboratory personnel, and monitoring of internal processes.

Features CLSI document: GP27-A2—Using Proficiency Testing to Improve the Clinical Laboratory; Approved Guideline—Second Edition

27 March 2007 • 1:15 p.m. - 4:00 p.m.

Estimating Risk: Maximizing Patient Safety
D. Joe Boone, PhD, Division for Laboratory Systems, Centers for Disease Control and Prevention
Tina Krenc, ADD Core R&D Life Sciences, Abbott Diagnostics
Richard J. Miller, Dade Behring, Inc.
Donald M. Powers, PhD, President, Powers Consulting Service
Shirley H. Weber, Director, Clinical Laboratories, The University of Kansas Hospital

Physicians use examination results together with other available medical information to evaluate a patient and reach a diagnosis. In some cases, this may be the only basis for their medical decisions. Incorrect or late results can lead to inappropriate or delayed medical decisions, and actions that result in harm to patients. This session will address the need to present processes for managing risks—primarily risks to the patient, but also to the operator, other people and equipment, and the environment. Patient safety issues and current approaches to reducing risk; application of proactive risk management to clinical laboratories; risk assessment tools, including process mapping, FMEA, and FTA; the application of FMEA (a case study); and integrating risk management into the quality system will be discussed. This session is designed for laboratorians and health professionals interested in implementing a process to identify the hazards associated with their areas of specialty; estimate, evaluate, and control the resulting risks; and monitor the effectiveness of that control in their home institutions.

Learning Objectives:
As a result of this workshop, participants will be able to:

• describe current approaches to reduce/eliminate errors and manage risk in healthcare settings;
• describe the benefits of implementing proactive risk management in the clinical laboratory;
• list and describe currently available risk management tools, including process mapping, failure modes and effects analysis [FME(C)A], and fault tree analysis; and
• describe means for integrating risk management into the quality system.

When asked about the benefits CLSI’s educational track sessions bring to CLMA attendees, Daniel W. Tholen, MS, A2LA, explains, “The CLSI process, and the documents that are produced, represent the collective wisdom of volunteer experts from the laboratory professions, diagnostic manufacturers, and regulatory agencies, developed in a spirit of consensus. This is profound information that can benefit everyone in the laboratory community.” He adds, “CLSI EduTracks not only teach the collective wisdom of experts from all segments of the laboratory community; they also provide an opportunity for people to get involved and to share their ideas with experts who develop the documents. Ideally, these sessions will entice other laboratory people to get involved—it is a very welcoming process.”

CLMA ThinkLab ’07 is approved for continuing education credit from ASCP (CMLE), ASCLS (P.A.C.E.), California, and Florida. A Certificate of Attendance is also available to those who must submit proof of attendance to their professional associations.

Credit hours are calculated on an hour-for-hour basis (i.e., a one-hour program is worth 1.00 credit hour; a one-and-one-half-hour program is worth 1.50 credit hours). The number of credits an individual attendee receives will be based on the types and number of sessions attended.

For complete event details and registration information, visit www.clmathinklab.org.

Come visit CLSI at Booth #1041. Receive a flyer for a special, limited-time discount equal to member pricing on CLSI documents mentioned in each of the CLSI EduTrack sessions.