NCCLS eNews - 9 September 2004 (Print All Articles)Back to Graphical Version | Search back issues What is IQLM? Creating the Institute for Quality in Laboratory Medicine
In April 2003, a Quality Institute Conference convened key stakeholders to Atlanta, Georgia to discuss the role of laboratory medicine in addressing healthcare problems. A broad cross-section of the healthcare community participated in the meeting, which was hosted by the Centers for Disease Control and Prevention (CDC). These participants urged the creation of a new organization that could engage the healthcare community in improving laboratory services. At the Quality Institute Conference, guest speaker Lucian Leape, M.D., with the Harvard School of Public Health, stated, “The idea that medical errors are caused by bad systems is a transforming concept.” “The Institute of Medicine report, Crossing the Quality Chasm, challenges healthcare providers to make systematic changes to our nation’s healthcare,” noted D. Joseph Boone, Ph.D., Associate Director for Science at the CDC. “The laboratory is a proven leader in establishing quality processes for the analytical phase of testing, but more can be accomplished by opening communications among laboratory professionals, clinicians, health systems, and patients.” CDC took the recommendations from the Quality Institute and initiated plans for a new public-private partnership organization to engage the health care community in improving the use of laboratory tests and services. “The Institute for Quality in Laboratory Medicine (IQLM) will be the first organization bringing together clinicians and laboratory professionals to work on advancing substantial improvements in quality, effectiveness, safety, and appropriateness for the broad universe of laboratory testing,” noted Toby Merlin, M.D., Associate Director for Laboratory Medicine at the CDC. The IQLM seeks to become a trusted source for information on laboratory practices. “Many organizations have made significant contributions to the advancement of the quality of laboratory practices,” explained Dr. Merlin. “But, no one group has the resources or the needed integration to move the quality agenda to the next level.” The IQLM aims to provide a forum for a diversity of organizations to discuss mechanisms to improve the quality and safety of laboratory services. “This ability to work collectively to address issues of communication, accountability, technology, and evidence-based practices is a cornerstone of the IQLM,” adds Dr. Boone. Robin Stombler, principal of a Washington-based healthcare development company, is working with the CDC to assist in bringing together all significant parties interested in improving the health of the public through the better use of laboratory tests. “The broad laboratory community includes laboratory professionals, clinicians, accrediting organizations, payers, health systems, device manufacturers, patients, and government agencies,” said Ms. Stombler. “While groups representing these interests have collaborated in the past, there was not one organization, until now, that brought all these parties together dedicated to a mission to promote improvements in laboratory testing and services. IQLM provides a unique opportunity.” The IQLM Agenda The IQLM aims to:
The Partners Over 30 organizations have agreed to join with the CDC in making the IQLM a reality. This collaboration of groups will assist in furthering the IQLM agenda. According to Ms. Stombler, “These organizations collectively represent over 350,000 physicians, approximately 200,000 laboratory professionals, 1,200 healthcare manufacturing companies, major accrediting bodies, all state public health laboratories, three million volunteers dedicated to improving the health of mothers and children, federal government agencies, and a significant share of the nation’s hospitals.” The Work Groups Before the IQLM was named, CDC was determined to implement promptly some of the recommendations from the 2003 Quality Institute conference. It began by establishing three teams to develop a process for (1) identifying a core set of indicators for quality in laboratory medicine; (2) identifying and demonstrating the feasibility of networks to collect critical information related to laboratory quality; and (3) identifying award categories for recognizing the best in quality laboratory practice. Volunteers were placed on each team based on their individual areas of expertise. The teams have been meeting face-to-face or by conference call at least once a month for the past year to pursue their tasks. The teams evolved into workgroups, and the workgroups eventually fell under the umbrella of the IQLM. The Near Future The IQLM is slated to become an independent, incorporated entity with its own Board of Directors and staff. CDC is providing initial funding to establish the independent organization. Individuals interested in participating in IQLM should watch the IQLM website for upcoming details on the 2005 conference registration and a call for abstracts. The web address is: http://www.phppo.cdc.gov/dls/iqlm/default.asp. NCCLS's Role NCCLS shares CDC's dedication to the improvement of the quality of medical testing and healthcare services and has actively forged partnerships for that goal during its 35-year history. As one of the more than 30 key stakeholders, NCCLS participated in the Quality Institute Conference, remains active in the IQLM Professional Advisory Partnership Council, and is represented on the IQLM Networks Group. As demonstrated by this active participation, NCCLS is committed to the establishment of the IQLM.
SARS: How Do NCCLS References Help the Healthcare Community Respond?
Severe acute respiratory syndrome (SARS) is a viral respiratory illness, now determined to be caused by a coronavirus called SARS-associated coronavirus (SARS-CoV). SARS appears to have originated in Guangdong Province, China, during the fall of 2002, and was first reported in Asia in February 2003. According to the World Health Organization (WHO), SARS affected more than 8,000 people in dozens of countries worldwide and claimed 774 lives from November 2002 through July 2003. During the outbreak, identification of the origin of SARS became critical, because the disease was spreading rapidly to healthcare workers in hospitals, requiring facilities to close and overwhelming healthcare systems. As a result of immense worldwide collaboration efforts, the pathogenic agent, SARS-associated coronavirus (SARS-CoV), was identified quickly. The collaboration to identify the agent included a multitude of laboratories within the Centers for Disease Control and Prevention (CDC), along with WHO and other partners. CDC Plays a Key Role in the Global Effort to Respond to SARS Outbreak
Regarding travel, CDC has refined the levels of travel notifications about disease occurrences on its website. In addition, CDC has been working with air carriers and shipping lines in a voluntary program to strengthen safeguards against biological threats. The organization conducts drills with airlines, airport officials, public health agencies, and emergency medical crews to practice attending to an infected passenger on an airliner or ship. By law, any ill passenger or crew member must be reported to a quarantine official for assessment and care. NCCLS Documents and Best Practices Focus on Detection and Safety The CDC reports that several laboratory tests have been identified to detect SARS-CoV. A reverse transcription polymerase chain reaction (RT-PCR) test can detect SARS-CoV in clinical specimens such as blood, stool, and nasal secretions. Serologic testing also can be performed to detect SARS-CoV antibodies produced after infection. Finally, viral culture has been used to detect SARS-CoV. In the library of NCCLS references, several documents provide best practices for the detection of pathogenic microorganisms and hard-to-detect viruses such as SARS-CoV. In addition, NCCLS provides general guidelines to follow to ensure the safety and protection of workers in the laboratory. Specifications for Immunological Testing for Infectious Disease (I/LA18) addresses specimen collection, handling, and storage, as well as performance criteria for the comparison of immunological test kits and specifications for reference materials. The document addresses the generic problems of preparation and characterization of antigens and antibodies, testing using these reagents, and understanding the results. Quantitative Molecular Methods for Infectious Diseases (MM6) provides guidance for the development and use of quantitative molecular methods, such as nucleic acid probes and nucleic acid amplification techniques of the target sequences specific to particular microorganisms. Protection of Laboratory Workers from Occupationally Acquired Infections (M29) is intended to be a practical tool for laboratory and healthcare workers. It promotes the essence of good laboratory practice to protect workers from infectious diseases encountered in the workplace. A few of the many laboratory practices that reduce the risk of infection include: standard precautions, safety devices, personal protective equipment, and appropriate decontamination and disposal of biological hazards. The working group currently revising the document will include laboratory precautions for performing diagnostic tests on specimens that may contain SARS. Viral Culture (M41) addresses several critical elements that must be considered in devising a viral culture procedure. These include specimen selection, preparation and inoculation; cell culture selection; pre- and postinoculation cell culture assessment, maintenance and quality control; identification of isolates; and reporting and interpretation of test results, including information regarding potential limitations of the procedure. This document does include information regarding the potential for the inadvertent isolation of agents (e.g., SARS, poxviruses) that are not appropriate for the BSL-2 setting. For the latest information from CDC about the current SARS situation, complete details on the recommendations and guidelines for public health and healthcare officials to respond, and travel health notifications, visit www.cdc.gov/sars/. For more information about NCCLS references and best practices, visit www.nccls.org. Press Releases
NCCLS Announces Availability of New Standard on Procedures for the Collection of Arterial Blood Specimens This standard, Procedures for the Collection of Arterial Blood Specimens; Approved Standard—Fourth Edition (H11-A4), will be particularly valuable to those involved in blood specimen collection, such as clinical laboratory directors, respiratory therapists, physicians, physicians in training, nurses, medical technologists, exercise physiologists, phlebotomists, and perfusionists. Read the complete press release. NCCLS Announces Availability of New Guideline on Performance of Single Cell Immune Response Assays This document, Performance of Single Cell Immune Response Assays; Approved Guideline (I/LA26-A), will provide laboratory methods for the growing field of immune-based therapy. Read the complete press release. View the complete listing of NCCLS press releases. Notice of Vote and Comment Deadline for Consensus DocumentsNotice of Vote and Comment Deadline for Consensus Documents: (HS3-A) Pulse Oximetry and (MM14-P) Proficiency Testing for Molecular Methods 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 HS3-A to be received in the Executive Offices is 8 November 2004. HS3-A—Pulse Oximetry; Approved Guideline The deadline for the completed ballot for MM14-P to be received in the Executive Offices is 8 December 2004. MM14-P— Proficiency Testing for Molecular Methods; Proposed Guideline
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 DocumentsPrecision (EP5-A2); Arterial Collection (H11-A4); Inpatient Medication Usage (HS10-A); Fluorescence Intensity (I/LA24-A) and Cellular Immune Functional Assays (I/LA26-A) 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. EP5-A2—Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline—Second Edition H11-A4— Procedures for the Collection of Arterial Blood Specimens; Approved Standard—Fourth Edition HS10-A—Application of a Quality System Model for Inpatient Medication Use; Approved Guideline I/LA24-A—Fluorescence Calibration and Quantitative Measurement of Fluorescence Intensity; Approved Guideline I/LA26-A— Performance of Single Cell Immune Response Assays; Approved Guideline -Second Notice- EP14-A2— Evaluation of Matrix Effects; Approved Guideline—Second Edition M29-A3— Protection of Laboratory Workers from Occupationally Acquired Infections; Approved Guideline—Third 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 Published ISO Standards
-Published ISO/TC 212 and ISO/TC 76 Standards- (ISO 15198:2004) Clinical laboratory medicine – In vitro diagnostic medical devices – Validation of user quality control procedures by the manufacturer (ISO 1135-4:2004) Transfusion equipment for medical use – Part 4: Transfusion sets for single use -Draft ISO Standards- (ISO/DTR 22367) Medical laboratories – Reduction of error through risk management and continual improvement (ISO/DIS 22870) Point-of-care testing (POCT) – Requirements for quality and competence To purchase these recently distributed ISO documents, shop NCCLS. Focus on Global Terminology
For complete details on these and other internationally accepted terms, access NCCLS’s Harmonized Terminology Database. In the database, find standard, internationally preferred terms and definitions, related terms, terms that are not acceptable in the international standards community, and illustrative notes and examples. Seeking Volunteer Participation for Document Revision – Call for NominationsT/DM8-A to A2, Urine Drug Testing in the Clinical Laboratory The Area Committee on Clinical Chemistry and Toxicology is inviting subcommittee participation to carry out revisions of NCCLS document T/DM8-A , Urine Drug Testing in the Clinical Laboratory. This guideline is concerned with testing urine specimens to detect drug abuse (workplace testing programs, criminal justice testing, rehabilitation programs, etc.). In revising T/DM8 to address changes in standards for forensic drug testing (e.g., new SAMHSA guidelines) potential changes include: a) alternate matrices; b) new cut-off values; c) new drugs/drug metabolites; and d) specimen validity testing. Expanding the guideline to address clinical drug testing (for example, drug abuse screening for emergency room patients), will also be considered. Requested Expertise: Members should have current knowledge and experience with clinical and/or forensic toxicology to address the revision objectives outlined. 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 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 9 October 2004.
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