NCCLS eNews - 5 May 2004 (Print All Articles)Back to Graphical Version | Search back issues Improving Quality with NCCLS Consensus Documents and Products
Leading healthcare professionals around the world are implementing quality practices to improve their organizations. This commitment to quality laboratory and healthcare services increases patient safety, reduces error, eliminates waste, improves performance, enhances customer and employee satisfaction, and increases profitability. As economic and resource pressures build, a global view of internationally accepted quality activities is necessary. On an ongoing basis, laboratorians and professionals in the healthcare community must ensure that patients’ needs are being met by safe, effective, and timely healthcare services. In order to continue to evolve and implement quality systems, dynamic supports, references, and guidance are essential. How Do NCCLS Documents Improve Quality? NCCLS’s quality management system model works to strengthen quality initiatives by addressing services’ paths of workflow from beginning to end. A path of workflow is the description of the necessary steps to deliver the particular product or service that the organization or entity provides. All services follow these processes to deliver quality information. NCCLS’s documents aid an organization’s implementation of quality assurance programs by providing guidance for standardized testing procedures from the initial (pre-examination) stages of specimen collection, handling, and transport, through the intermediate (examination) stages, to the final stages (post-examination) of recording and interpreting the results; supplying references which help in the verification of test performance and ensure the reliability of results; and delivering tools to ensure appropriate specimen collection and preparation techniques, validation of test results, and appropriate quality control procedures. Overall, NCCLS’s documents and products serve as a much needed asset in achieving improved healthcare quality and, ultimately, reducing medical errors. The Quality System Management Approach Quality requires a systematic approach which defines the organizational structure, resources, processes, and procedures needed to implement quality management. A quality management system defines how the processes interrelate departments and services. Instituting a quality system approach should, by design, build quality into the workings of a clinical laboratory or any other healthcare service. The implementation of a quality management system approach is increasingly critical for organizations to facilitate licensure, satisfy accreditation, build credibility, reduce operating costs, and achieve success. NCCLS subscribes to a quality management system approach in the development of standards and guidelines. This approach facilitates project management; defines document structure via a template; and provides a process to identify needed documents through a gap analysis. NCCLS document HS1-A, A Quality System Model for Health Care, provides the infrastructure for developing a quality system that will meet the quality objectives of a healthcare service; and GP26-A2, Application of a Quality System Model for Laboratory Services , is an application document of the quality system approach for the clinical laboratory. These documents, specifically related to quality systems, parallel the efforts of ISO 15189, Medical laboratories – Particular requirements for quality and competence. When used in conjunction with ISO 15189, these documents provide medical laboratories with specific tactics for implementing quality guidelines. Accordingly, all NCCLS healthcare services documents strive to meet the same generic ISO standards, including the ISO 9000 series and ISO/IEC 17025:1999, General requirements for the competence of calibration and testing laboratories (formerly ISO/IEC Guide 25). Using the NCCLS Model: HS1-A — A Quality System Model for Health Care and GP26-A2 — Application of a Quality System Model for Laboratory Services HS1-A — A Quality System Model for Health Care sets out a structured approach to organizing, creating, and maintaining information (defined by an organization’s policies, processes, and procedures) to help eliminate "gaps" in an organization or service’s processes and to guide organizational quality improvement efforts. This guideline provides a structure for a comprehensive, systematic approach to build quality into the healthcare service’s processes, assess the service’s performance, and implement quality improvements. The document includes 12 “quality system essentials” or “QSEs.” Information is provided about the processes and procedures that a healthcare organization or service needs to have in place to ensure that its work operations are functioning as intended to meet customer, regulatory, and accreditation requirements, and to provide for the highest level of patient safety. GP26-A2 — Application of a Quality System Model for Laboratory Services provides the necessary background information and infrastructure to develop a quality system that will meet a laboratory’s quality objectives and be consistent with the quality objectives of an institution. Specifically, it lays the foundation for defining all activities of the overall management function that determine quality policy objectives and responsibilities; and for implementing them by means such as quality planning, process control, quality assurance, and quality improvement within the system. In addition to GP26-A2, NCCLS documents HS4-A, Application of a Quality System Model for Respiratory Services; HS5-A, Application of a Quality System Model for Medical Imaging Services; and HS10-P, Application of a Quality System for Inpatient Medication Use are intended for use with HS1 when developing an organization’s quality system. These documents describe various QSEs and paths of workflow for maintaining quality in the specific disciplines of respiratory services, medical imaging services, and inpatient medication use. NCCLS is currently revising documents HS1 and GP26. The working group is incorporating a global view of internationally accepted quality activities applied to a given scope of work. The anticipated availability date for the revised publications is November 2004. A healthcare quality system describes, documents, implements, measures, and monitors the implementation and effectiveness of the work operations of any service unit or support operation in the organization. It provides a means to direct and control an organization with regard to quality. The NCCLS model sets out a structured approach to organizing, creating, and maintaining the necessary information for implementation and effectiveness of work operations, so all employees know how the organization functions and of its commitment to quality. Future Quality Initiatives In order for quality initiatives to succeed, organization decision-makers must be committed to their success, and all organization employees must understand that they are part of the solution and have a role to play in ensuring a quality program. By focusing on its mission to facilitate the development and availability of useful, effective, global consensus best practices, NCCLS provides the healthcare community with a valuable tool to achieve a high level of quality patient care. For more information and future developments about the NCCLS Quality System Approach, visit http://www.nccls.org or call the NCCLS Executive Offices +610.688.0100. Press Releases
NCCLS Signs Updated Partnership Agreements with JCCLS and the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) NCCLS Signs Updated Partnership Agreement with JCCLS During the 2004 NCCLS Leadership Conference, 18-20 March 2004, Donna M. Meyer, Ph.D., NCCLS President, and Kiyaoaki Watanabe, M.D., JCCLS President, signed an updated partnership agreement with the mutual goal of providing worldwide consensus standards. Promoting harmonization and a sense of global cohesiveness in standards-development is a key strategic priority for both organizations. Read the complete press release. NCCLS Signs Updated Partnership Agreement with the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) During the 2004 NCCLS Leadership Conference, 18-20 March 2004, Donna M. Meyer, Ph.D., NCCLS President, and Mathias M. Müller, M.D., IFCC President signed an updated partnership agreement with the mutual goal of providing worldwide consensus standards. Promoting harmonization and a sense of global cohesiveness in standards-development is a key strategic priority for both organizations. Read the complete press release. NCCLS Announces Availability of New NCCLS Document on Clinical Laboratory Safety; Approved Guideline-Second Edition Safety First. Aspects of a safety program addressed in this guideline include maintenance and inspection, personal safety, warning signs and labels, fire prevention, and electrical and radiation safety, as well as other potential laboratory hazards. This document on Clinical Laboratory Safety; Approved Guideline-Second Edition (GP17-A2) is written for laboratorians who are responsible for developing and implementing a safety program. Read the complete press release. NCCLS Announces Availability of New NCCLS Document on Training and Competence Assessment; Approved Guideline-Second Edition Quality patient care starts with a qualified, trained staff. Developing training and competency assessment programs that meet quality and regulatory objectives can be an overwhelming task. NCCLS has updated its Training and Competence Assessment; Approved Guideline-Second Edition (GP21-A2) to build on a solid foundation of documented operations processes and procedures, with accompanying training documents. This guideline provides a structured approach for using documented processes, related procedures, training guides, and assessment tools for the development of training and competence assessment programs. Read the complete press release. View the complete listing of NCCLS press releases. Notice of Vote and Comment Deadline for Consensus Document(H18-A3) Handling and Processing of Blood Specimens NCCLS announces that the following documents are submitted for vote as candidate-for-advancement consensus documents. The documents and ballots are posted on NCCLS Forums to delegates of Active and Associate Active member organizations. If you are a voting delegate or alternate, we request that you access NCCLS Forums to obtain the candidate-for-advancement documents. Login to access NCCLS Forums The deadline for the completed ballot for H18-A3 to be received in the Executive Offices is 6 July 2004. H18-A3 — Procedures for the Handling and Processing of Blood Specimens; Approved Guideline—Third Edition -Second Notice- The deadline for the completed ballot for EP5-A2 to be received in the Executive Offices is 7 June 2004. EP5-A2 — Evaluation of Precision Performance of Quantitative Methods; Approved Guideline—Second Edition Under our Administrative Procedures, an NCCLS document approved by the area committee at the first level of the consensus process is submitted to the NCCLS 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 an NCCLS document. Please send your completed ballot to the Executive Offices by the above deadline. In the NCCLS 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. For more information on Active and Associate Active membership, click here. Recently Approved Document(M44-A) Antifungal Disk Diffusion Susceptibility Testing of Yeasts NCCLS is pleased to announce that the following documents have been approved by the Board of Directors for publication. See the text following this list for information on options for member and nonmember organizations to obtain copies. M44-A — Method for Antifungal Disk Diffusion Susceptibility Testing of Yeasts; Approved Guideline -Second Notice- GP17-A2 — Clinical Laboratory Safety; Approved Guideline—Second Edition GP21-A2 — Training and Competence Assessment; Approved Guideline—Second Edition
The NCCLS 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 which participates in the consensus process by carefully reviewing and commenting on the standard or guideline. The listed approved consensus documents are available for purchase. You may automatically receive or select approved-level documents as a member benefit. For information on joining NCCLS, and viewing membership options and benefits, click here. Recently Distributed Draft ISO Standard(ISO/ PDTR 18112) In Vitro Diagnostic Medical Devices for Professional Use ISO/ PDTR 18112, ISO Technical Report: In Vitro Diagnostic Medical Devices for Professional Use – Summary of Regulatory Requirements for Information Supplied by the Manufacturer -Second Notice- ISO/FDIS 15198, Clinical laboratory medicine - In vitro diagnostic medicine devices - Validation of user quality control procedures by the manufacturer ISO/CD 18112-1, Clinical Laboratory Testing and In Vitro Diagnostic Test Systems – In Vitro diagnostic medical devices – Information supplied by the manufacturer – Part 1: In vitro diagnostic reagents for professional use To purchase these recently distributed ISO documents, shop NCCLS. Seeking Volunteer Participation on Project Committees - Call for NominationsIT Security of IVD Instruments and Software Systems; Automated Verification of Clinical Laboratory Test Results; AST2-A to A2, Point-of-Care In Vitro Diagnostic (IVD) Testing; and AST3-A to A2, Wellness Testing Using IVD Devices NCCLS is seeking subcommittee membership for the following proposed projects: IT Security of IVD Instruments and Software Systems; and Automated Verification of Clinical Laboratory Test Results, which are undergoing a progressive review process to assess the need and market potential for consensus document development. The proposals listed below have not yet been authorized for document generation. Rather, NCCLS is undertaking external assessments as background for consideration of approval. We are soliciting nominations at this early stage in order to: help assess member interest; identify a preliminary volunteer pool to promptly form the subcommittees; and expedite NCCLS’s overall process for developing consensus standards and guidelines. In addition, the Area Committee on Point-of-Care Testing is inviting subcommittee participation to carry out revisions of NCCLS documents: AST2-A to A2, Point-of-Care In Vitro Diagnostic (IVD) Testing; and AST3-A to A2, Wellness Testing Using IVD Devices. NCCLS volunteers, experts in the medical-testing community, share and enhance their technical expertise and work together to develop reliable and practical consensus standards and guidelines to improve the efficiency and effectiveness of clinical laboratory practices and medical testing. Join NCCLS volunteers! For more information on volunteer participation, to see the objective of the projects and the required volunteer expertise for members of the subcommittees, and to submit a nomination, click here. The deadline to submit nominations, including a curriculum vitae and disclosure of interests form, to the NCCLS Executive Offices is 4 June 2004. Meeting Calendar
10 -11 May 2004 7-9 June 2004 11-12 June 2004 13-15 June 2004 Check out the complete calendar of meetings. Upcoming Events and Exhibits
Council of Science Editors Plan to attend conference session highlighting the NCCLS Harmonized Terminology Database: International Standards: Research Guidelines and Harmonized Terminology American Society of Microbiology (ASM) 104th General Meeting Saturday, 22 May • 8:30 a.m. – 4:30 p.m. Tuesday, 25 May • 6:30 a.m. - 7:30 a.m. Plan to attend ASM Sunrise Seminar, Update on NCCLS Veterinary Antimicrobial Susceptibility Testing Tables, highlighting NCCLS document: M31-S1, Performance Standards for Antimicrobial Disk and Dilution Susceptibility Tests for Bacteria Isolated from Animals; Informational Supplement Presented by: Thomas R. Shryock, Ph.D., Elanco Animal Health; and Ching Ching Wu, D.V.M., Ph.D., Purdue University View the full list of upcoming events, exhibits, and training. Join Us
Membership is the most effective way for your organization to participate in the standards-development process and to influence the consensus process. By having an active voice, participants can work to ensure that goals of the standards and guidelines directly affecting them are practical and achievable. To find out more information about NCCLS membership options and benefits, and to download a membership brochure and application, click here. Maximize your participation in the NCCLS voluntary consensus process. You have the opportunity to influence project development. Members are encouraged to participate as volunteers on project committees. Find out more information about volunteer participation. New and Sustaining Members
New Members Active Associate Active Barnes-Jewish St. Peters, USA Sustaining Members NCCLS acknowledges those partnering organizations that have made a special financial commitment above and beyond their membership dues. Gold Level
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