National Laboratory Training Network in collaboration with APHL's Quality Systems Program
The Clinical and Laboratory Standards Institute (CLSI) Quality Management System Model: Overview and Update
Over a decade ago, volunteers from the CLSI developed a simple model to make sense out of all the many requirements that regulatory, accreditation, state, and other organizations have for laboratories that perform clinical testing. The model organizes requirements by category; there are twelve categories called Quality System Essentials (QSEs). The requirements grouped into each QSE are organized in the order in which the activities happen in a laboratory. Developing your laboratory’s processes and procedures to include all the activities specified in the requirements ensures that your laboratory meets requirements in the course of performing laboratory work. In this manner, quality is built into laboratory work and not seen as an extra activity.
· Describe how to use Quality System Essentials (QSEs) to organize regulatory and accreditation requirements applicable to the public health or clinical laboratory setting.
· Diagram a generic model for a quality management system.
· Describe the twelve QSEs that support the model.
· Explain how to use the QMS model to optimize common laboratory processes.
CLSI Documents that Support the Quality System Essentials
Learn how the CLSI uses a voluntary consensus process to develop best practices in clinical and laboratory testing and promote their use throughout the world. Through a voluntary consensus process that involves industry, governments and the health care professions, CLSI prepares standards, guidelines, and reports that help laboratory professionals implement efficient and effective management and technical processes and procedures in clinical, public health and research laboratories. Note: This session is not applicable for continuing education credit.
· Differentiate between CLSI standards, guidelines, and reports.
· Explain how to select the appropriate CLSI standard, guideline, or report for your laboratory’s needs.
Introduction to the Work Process Model
All work happens in a series of activities known as “processes,” and laboratory work is no exception. Work processes can be documented in a flowchart, using symbols that represent activities and decisions that describe “who does what, and when.” Whereas processes visually depict “how it happens here,” procedures are meant to provide specific instructions for how to perform only one activity in a process. This program introduces a model that assists laboratories in identifying work processes, preparing procedures for process activities, and linking the process and its respective procedures to effective training and competence assessment.
· Describe the eight parts of the work process flow model.
· Differentiate between “process” and “procedure”.
· Explain how the process flowchart and procedures can be used in training and competence assessment programs.
A New Model for Procedures Manuals
Work does not occur in alphabetical order. Work does occur in processes. Processes describe the sequence of activities performed by one or more persons that transform inputs into outputs. An example of a process would be the activities performed from the time a sample is received in the laboratory to the time it is at the point where testing can begin. This program describes how to organize effective procedure manuals for both manual work processes and automated analyzers.
· Describe how to use work processes to enable organization of a more effective procedure manual.
· Explain the steps to produce a more effective table of contents for procedure manuals.
· List the benefits of using analyte attribute tables to summarize key analyte information for ready reference.
Lucia M. Berte, MA, MT(ASCP), DLM, CQA, CQM(ASQ)
Laboratories Made Better! P.C., Broomfield, CO
As a health care professional who has specialized in quality management systems in health care ancillary services for almost 20 years, Lucia Berte is committed to reducing laboratory problems that affect quality and patient safety. Ms. Berte has a strong background in laboratory medicine, with certifications as a medical technologist, specialist in blood banking, and diplomat in laboratory management and experience as a laboratory supervisor and manager. She also has many years experience in quality management and is certified as both a quality auditor and quality manager. Lucia’s quality management experience includes working with health care clinical services such as the medical laboratory, respiratory care, medical imaging, pharmacy, and rehabilitation. Her approach has also been used with health care support services such as human resources, accounting, materials management, and medical records. She is the author of numerous articles, chapters, and books on quality management and is a frequent workshop presenter and teleconference speaker.
Who Should Attend:
This intermediate-level program is intended for managers, supervisors, clinical laboratory scientists or quality assurance officers in clinical or public health laboratories who are responsible for developing procedures and procedure manuals in the laboratory.
Continuing Education Credit:
The Association of Public Health Laboratories (APHL) is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. The following contact hours will be awarded upon successful completion of the programs: Part 1: 2.0 contact hours, Part 3: 1.5 contact hours and Part 4: 1.0 contact hours.
Note: P.A.C.E.® credit is not offered for Part 2
Special Needs and Information:
In compliance with the Americans with Disabilities Act, closed captioning is offered for the course content.
Windows: Microsoft Windows XP, Windows Server 2003, Windows Vista, Windows Server 2008, Windows 7. Microsoft Internet Explorer 6.0 SP1 or later, Firefox 2.0 or later, or Google Chrome 1.0 (Chrome is only supported on Mediasite version 5.0.3 and later). Windows Media Player 9 or later. For Firefox and Chrome playback, Silverlight 1.0 or later (viewers are prompted to install this when attempting to view a presentation). If using a Silverlight player instead of a Classic player, Silverlight 3.0 or later is required. Broadband Internet connection (256 Kbps or more)
Macintosh: Mac OS X 10.4.8 or later, Safari 2.0.4 or later or Firefox 2.0 or later. Silverlight 1.0 or later (viewers are prompted to install this when attempting to view a presentation). If using a Silverlight player instead of a Classic player, Silverlight 3.0 or later is required. Broadband Internet connection (256 Kbps or more).