CLSI eNews - 1 March 2006 (Print All Articles)
Executive Vice President's Message
The CLSI Leadership Conference & Workshop
Melding the hottest issues of the day—Equivalent (Alternative) Quality Control, Patient Safety, and Risk Management—our annual leadership conference features a full-day hands-on workshop, Risk Management Tools for Improved Patient Safety. Presented by experts in their fields, this event voices the most current perspectives from industry, government, and healthcare professionals on these prevalent topics. This workshop is aimed at clinicians, laboratorians, manufacturers, and government representatives 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. The workshop is on 28 April and offers attendees continuing education credit.
Take the time to meet with and learn from your colleagues and peers from around the world, keep up with the latest trends in laboratory and patient testing, and get continuing education credit to meet your professional needs.
Finally, we wish to thank in advance our events sponsors for your dedicated support: AdvaMed, AACC, AAFP, AARC, ASCLS, ASCP, ASTM, CAP, CDC, CLMA, CMS, COLA, CSMLS, IFCC, and IQLM.
Register at www.clsi.org or feel free to call anyone in the office at +610.688.0100.
I look forward to seeing you in April.
Dr. Louis J. Dunka - A Tribute and Remembrance
Louis J. Dunka, PhD, a well-respected clinical chemist and in vitro diagnostic clinical scientist, will be missed greatly. Lou passed away leaving behind his daughter Ashley. He was 64 years old. Lou received his BS degree in Analytical Chemistry from St. Joseph’s University, Philadelphia, PA, and then his PhD in Biochemistry from the University of Alabama (UAB), Birmingham, AL, where he developed “An Automated Method for the Determination of Triacylglycerols (Triglycerides) in Serum” for his dissertation. Lou’s career took him into the IVD industry in product development, quality and regulatory, industry relations to clients, professional societies, regulatory and governmental agencies, and industry advocacy groups like HIMA and ADVAMED. I personally have had the benefit of knowing Lou for almost 30 years in each of his roles, first at American Hospital Supply’s Scientific Products (Dade Division), Fisher Diagnostics, Syva, IL, and finally at LifeScan. Lou served in many capacities in each of these companies. One consistent theme, however, in his career was participation in CLSI subcommittees, area committees, and on panels/working groups associated with liaison organizations such as ADVAMED, AACC Industrial Liaison Committee, AACC divisions (Industrial Division LIS, and CPOCT), ISO, IHE, IEEE, and HL7.
While fulfilling his corporate responsibilities with great enthusiasm, professionalism, and intensity, he was always available to help with a standards project, organize an AACC divisional meeting, or review an article or a document with the same attributes. He was someone you respected for his common sense, his network, and knowledge of the field. Lou was someone you could count on to get the job done on time, on budget, and to everyone’s expectations. His latest work as Chairholder of the Area Committee for Point-of-Care Testing was to forge new ground with a working group composed of industry, government, and providers, that was expanded to include researchers and clinicians involved in the field of continuous glucose monitoring. The purpose of the group is to establish common terminology and understanding of continuous glucose sensing with the goal of establishing a standard for glucose monitoring. His role in this group and CLSI will be greatly missed.
I’m thankful for Lou’s friendship and for all the activities we shared over the years, both professional and social.
Respectfully submitted by his friend and colleague,
Jeffrey A. DuBois, PhD
Positioning for Successful Quality Management System Implementation
The implementation of a strong quality management system (QMS) provides a platform for continuous improvement in service delivery: enhancing customer service, meeting regulatory and accreditation assessments, and creating a culture of total service excellence. The best contribution an organization can make to improve quality is to understand, document, and follow policies, processes, and procedures in their full complexity. To establish a complete QMS, an organization needs to define the infrastructure known as the quality system essentials (QSEs) necessary to provide quality care to patients. The QSEs are the foundational building blocks that support the organization’s work operations, also called path of workflow.
Every service has a defined path of workflow, which represents the sequence of activities from the initiation of a request for a service through the provision of those services, and any necessary follow-up. In the clinical laboratory, the path of workflow begins with an order for a laboratory examination (test) and proceeds to provision of the report, and any necessary follow-up consultation. Each healthcare organization can use the same quality system essentials to manage its respective path of workflow, thus developing one universal set of policies, processes, and procedures for the quality system essentials that apply to all the services in the entire organization.
Essential Quality Management System Resources
CLSI has recently released new editions of widely accepted “gold standards” of authoritative documents and products within its quality collection. These documents, developed by recognized experts, provide guidance to ensure that clinical and healthcare organizations are functioning optimally to meet customer, regulatory, and accreditation requirements, and provide the highest level of patient care.
CLSI Quality System Toolkit (HS1-A2-C)
In addition to the new toolkit, CLSI also offers a special discounted bundled collection of documents to meet targeted needs in its Quality Series (SC24-L) with the key documents for quality management activities.
Compliance Resources for Improving Quality
Technical aspects of a healthcare organization’s path of workflow are published in country-specific accreditation requirements. While each country will have its own requirements, they all have in common the need to define, document, and train for the organization’s activities. Laboratories and healthcare organizations that build accreditation requirements into their routine daily practice will always be well prepared for inspections and assessments.
CLSI provides an expansive collection of products to support implementation of a complete quality management system. Through its recognized consensus process, CLSI delivers the essential resources that organizations need to improve the quality of patient testing and healthcare services and to meet regulatory and accreditation requirements. CLSI serves as a resource to fill a gap where regulatory requirements are not currently in place, and provide practical recommendations and practices to meet regulatory requirements.
Upcoming Procedure Manual Document and Toolkit Support a Quality Management System and Compliance Needs
CLSI will soon release new editions of its procedure manual standard and toolkit:
The newly revised Laboratory Documents: Development and Control; Approved Guideline—Fifth Edition (GP2-A5), scheduled for publication in late March 2006, has been updated to include: examples of the use of process flowcharts to depict linkages between laboratory procedures; elements for writing process and procedure documents for preexamination, examination, and postexamination activities; information about writing procedure documents for multitest automated analyzers and for laboratory information systems; and the eight elements of document control.
CLSI Procedure Manual Toolkit (GP2-A5-C)
At a special discount, CLSI also offers GP2-A5 as part of the bundled collection of documents, Regulatory Compliance (SC31-L), which includes documents that will help laboratories comply with regulatory requirements.
Partners to Promote Excellence in Performance
CLSI consistently maintains open communication with regulatory and accreditation organizations and it partners with them for the mutual goal of providing the tools needed to improve the quality of patient care. In November 2005, CLSI and COLA announced a partnership directly linking best practice standards, guidelines, and educational services to regulatory compliance and laboratory accreditation. Similarly, numerous CLSI documents are referenced in the College of American Pathologists (CAP) Laboratory Accreditation Program Inspection Checklists and serve as key resources for helping laboratories to satisfy accreditation requirements. During CAP’s on-going process of updating accreditation checklists, the associated reference lists will be updated with the most recently published editions of CLSI’s standards and guidelines.
Global Initiatives Provide a Complete Approach to Quality Programs
CLSI has developed the “how to” tools for implementation of quality requirements prescribed by the International Organization for Standardization (ISO). ISO 9001 defines a process model for quality that any business should use to manage its operations, ISO 17025 specifies the general requirements for the competence to carry out tests and/or calibrations, including sampling, and ISO 15189 defines standards for quality management in the medical laboratory environment.
The primary objective of ISO 15189 is to create the foundation for quality in medical laboratory services. CLSI quality guidelines provide practical approaches to facilitate organizational execution of the requirements prescribed in ISO standards and aid in the successful implementation of a quality management system. CLSI’s series of quality management system guidelines complement the efforts of ISO 15189 to provide a comprehensive quality management system approach for medical laboratories worldwide.
ISO 15189 does not substitute for US government regulatory requirements such as the CLIA ’88 legislation; however, alignment with ISO 15189 by various US accreditation agencies, such as COLA and CAP, and the establishment of ISO 15189 as the primary national standard for laboratories in many other countries around the world, strengthens the importance of this international standard. ISO 15189 is increasingly becoming the overriding, uniform global approach for quality and competence to which clinical laboratories and healthcare services aspire.
CLSI Commitment to Quality
With the rapid evolution of techniques, tests, methods, and technologies in the healthcare industry, CLSI continues to respond with the essential resources and vital guidance to improve quality management, assure patient safety, and achieve success. Through the development of new quality documents and products, ongoing efforts to forge partnerships with government and accreditation bodies, and harmonization with key ISO standards, CLSI equips organizations worldwide with the tools to provide consistent, compliant practices and efficient use of resources. Undoubtedly, CLSI embraces its commitment to advance quality in healthcare testing now and in the future.
The involvement and expertise of professionals with frontline experience is the key to the CLSI’s unique, effective consensus process. Comments and questions about CLSI documents are welcome; this essential feedback serves as the basis for updated document editions. All comments and responses are formally addressed and published in the next edition of the document. For more information about Clinical and Laboratory Standards Institute references and best practices, visit www.clsi.org.
Quality Qorner: Low Carb Documents
Lucia M. Berte, MA,MT(ASCP)SBB,DLM; CQA(ASQ)CQMgr
My local newspaper ran a column after the holiday season by a woman who had been a former mayor and state representative and has been actively involved in the community for a long time. She included a poem by an anonymous author entitled, “’Twas the month after Christmas” that began like this:
“`Twas the month after Christmas and all through the house
The poem continued in its traditional style and it was as if I had written it about my tasty holiday experience! It ended with the line, “Happy New Year to all and to all a good diet!”
I’ve been trying hard to make low carb living part of my lifestyle. It’s definitely a struggle at holiday time, but for the rest of the year it’s doable…and desirable. A low carb diet pares us down to eating essential, healthful foods that are good for us and keep our bodies healthy.
As a long-time inspector, assessor, consultant, and reader of laboratory documents, it’s apparent to me that laboratory documents need to go on a “low carb diet.” Just as unused carbs turn into fat that’s unhealthy for our bodies, unused laboratory documents turn into fat procedures manuals that are unhealthy for laboratory staff.
It’s not healthy to have:
I could list many more problems with the way laboratory procedures manuals have been historically written and organized, but I’m sure you know well what I mean. So the challenge is how to put our laboratory documents on a low carb diet, trim the fat down to lean muscle, and make them healthy.
Food is made up of proteins, carbohydrates, and fats, each with an important role in maintaining the human body. However, there can be too much of a good thing; extra pounds result from accumulation of unused carbohydrates and fat. Using this analogy, we could say that the “meat” of a laboratory document—that is, the information needed to fulfill the document’s purpose—is the protein and that untimely, surplus or out-of-place information is the carbs and fats that need elimination to make the document function more effectively. Continuing with the analogy, if a vital amine (aka, “vitamin”) is missing from the food in our diet we can suffer dire consequences. Likewise with laboratory documents; when vital information is missing from procedural instructions, errors and omissions occur that can compromise patient safety.
Probably everyone reading this has purchased a diet book at some time or another—I’ve found the “South Beach” ones to be particularly useful. Fortunately, there is a new diet book for laboratory documents that has reorganized protein, carbs, and fat into palatable document “recipes.” Just as recipes can be organized into categories such as appetizers, entrees, and desserts, laboratory documents can be categorized into policies, processes, and procedures.
The first edition of NCCLS guideline GP2 was released more than 25 years ago with a “recipe” for the contents of a laboratory procedure that was based on individual analytes. However, not all laboratory procedures are analytic. For example, neither the entire preanalytic portion of the laboratory’s path of workflow nor the related laboratory computer system procedures are about testing. Therefore, the original recipe did not fit all types of laboratory documents and the added carbs and fats have made the documents extremely unwieldy. Therefore, in 2002, the NCCLS (now the Clinical and Laboratory Standards Institute, CLSI) began a recipe makeover.
A hard-working group of volunteers has just updated guideline GP2 into the new edition that is being released by CLSI this month. GP2-A5 was renamed Laboratory Documents: Development and Control.1 This guideline represents the ultimate low carb diet for laboratory policy, process, and procedure documents. Laboratories that actually went on this document diet and have seen the results contributed the examples in the appendices. You won’t believe the difference! Talk about slimmed down!
As individuals, we all know that we should eat better and get more fit and trim; likewise, we all know that our laboratory documents should follow the same advice. However, it’s what we do about what we know that actually makes the difference.
1. CLSI. Laboratory Documents: Development and Control; Approved guideline
GP2-A5. Wayne, PA: Clinical and Laboratory Standards Institute, 2006.
Available at: www.clsi.org
Lucia Berte is a quality systems consultant in Westminster, CO who subjects herself and her clients to low carb (document) diets. References furnished on request. Send comments/questions to email@example.com.
Originally published in LABMEDICINE, March 2006. Reprinted with permission. ASCP©2006.
Molecular Diagnostic Methods for Infectious Diseases (MM3-A2); Infectious Disease Genotyping (MM10-A); Metrological Traceability and Its Implementation (X5-R); CDC Announcements: Eliminate Transmission of Hepatitis B Virus; New Laboratory Test to Detect Human Infections with Avian Influenza A/H5 Viruses
New CLSI Document Provides Valuable Guidelines for Molecular Diagnostic Methods for Infectious Diseases
New CLSI Guideline for Infectious Disease Genotyping
New CLSI Report on Metrological Traceability and Its Implementation
Special Announcements from the Centers for Disease Control and Prevention (CDC)
A Comprehensive Immunization Strategy to Eliminate Transmission of Hepatitis B Virus Infection in the United States
Read a synopsis of the updated recommendations for healthcare and public health professionals who provide care to pregnant women and infants.
Press Release: FDA APPROVES NEW LABORATORY TEST TO DETECT HUMAN INFECTIONS WITH AVIAN INFLUENZA A/H5 VIRUSES
Lab Test Developed by Centers for Disease Control and Prevention
Read full press release.
Vote and Deadlines
Autoverification of Clinical Laboratory Test Results (AUTO10-P); IT Security of In Vitro Diagnostic Instruments and Software Systems (AUTO11-P); Viral Culture (M41-P); Molecular Diagnostic Methods for Genetic Diseases (MM1-A2); Point-of-Care Connectivity (POCT1-A2); Point-of-Care In Vitro Diagnostic (IVD) Testing (POCT4-A2)
CLSI submits the following for vote as candidate-for-advancement consensus documents. The documents and ballots are available to delegates and alternates of Active and Associate Active member organizations through CLSI Forums.
POCT1-A2—Point-of-Care Connectivity; Approved Standard—Second Edition
AUTO10-P—Autoverification of Clinical Laboratory Test Results; Proposed Guideline
AUTO11-P—IT Security of In Vitro Diagnostic Instruments and Software Systems; Proposed Standard
M41-P—Viral Culture; Proposed Guideline
MM1-A2—Molecular Diagnostic Methods for Genetic Diseases; Approved Guideline—Second Edition
POCT4-A2—Point-of-Care In Vitro Diagnostic (IVD) Testing; Approved Guideline—Second Edition
Under our Administrative Procedures, a CLSI document approved by the area committee at the first level of the consensus process is submitted to delegates as a “candidate-for-advancement” consensus document. This begins the voting and approval period by the delegates.
As a delegate, your vote is to affirm (or reject) the document for advancement as a CLSI document. Please send your completed ballot to the CLSI offices by the above deadline.
In the consensus process, comments are invited at each publication stage. In each edition, the responsible committee includes a summary of comments on the prior edition and its responses to them. Any comments received on a candidate-for-advancement consensus document as a result of delegate voting and consensus review will be addressed by the committee during the document’s advancement.
Find out more about Active and Associate Active membership.
Recently Approved Documents
Protocols for Evaluating Dehydrated Mueller-Hinton Agar (M6-A2); Molecular Diagnostic Methods for Infectious Diseases (MM3-A2); Genotyping for Infectious Diseases (MM10-A); Metrological Traceability and Its Implementation (X5-R);
MM3-A2—Molecular Diagnostic Methods for Infectious Diseases; Approved
MM10-A—Genotyping for Infectious Diseases: Identification and Characterization;
X5-R— Metrological Traceability and Its Implementation; A Report
M6-A2—Protocols for Evaluating Dehydrated Mueller-Hinton Agar; Approved Standard—Second Edition
Our procedures have been designed to ensure that consensus has been achieved when a standard or guideline is published at the approved level. This means that a document has been rigorously reviewed by the authoring subcommittee, the area committee overseeing the project, the Board of Directors, and the medical-testing community that participates in the consensus process by carefully reviewing and commenting on the standard or guideline.
You may automatically receive or select approved-level documents as a member benefit. Find out more about joining CLSI: view membership options and benefits.
New ISO Standard
Clinical laboratory testing and in vitro diagnostic test systems (ISO/TR 18112)
ISO/TR 18112:2006 Clinical laboratory testing and in vitro diagnostic test systems — In vitro diagnostic medical devices for professional use — Summary of regulatory requirements for information supplied by the manufacturer
To purchase this and other ISO documents, shop in the CLSI online store.
Call for Nominations
Assessment of the Clinical Accuracy of Laboratory Tests Using Receiver Operation Characteristic (ROC) Plots
Clinical and Laboratory Standards Institute’s Area Committee on Evaluation Protocols has requested nominations to serve as subcommittee members to revise the CLSI guideline described below:
Specific Expertise/Work Experience Needed:
Review the objective of the project revision, and the requested volunteer expertise, and submit a nomination.
The deadline to submit the nomination form, including a curriculum vitae and disclosure of interests form, is 3 April 2006. Send to Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, PA 19087.
Visit Booth #1436 at CLMA ThinkLab '06, 18-21 March 2006
CLMA ThinkLab '06
16th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID)
"Quality Management Standards for Laboratories: An International Perspective" with Lucia M. Berte, MA, MT(ASCP)SBB, DLM
"Beyond Quality Assurance: Understanding a Quality System for the Laboratory" with Lucia M. Berte, MA, MT(ASCP)SBB, DLM
CLSI Meetings Calendar
Subcommittee on Mass Spectrometry: 7-8 March; Area Committee on Hematology: 27 March
Browse CLSI's complete calendar of meetings.
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