CLSI is looking for volunteers to serve on its consensus committees and subcommittees.
Volunteers selected to participate on a consensus committee or subcommittee will be responsible for assisting with development, oversight, and review of consensus documents. Other responsibilities include:
There are currently no calls for volunteers for Consensus Committees.
There are currently no calls for volunteers for Subcommittees.
CLSI is requesting nominations for volunteers to serve as members and contributors on document development committees for a new project and a document revision.
The CLSI Consensus Committee on Newborn Screening has a mission to lead, oversee, and expand the portfolio of CLSI newborn screening (NBS) products to meet the needs of the NBS community. Through this effort, the Consensus Committee continually develops projects that will ensure the CLSI NBS portfolio is up-to-date with related technological and scientific advancements.
The term “hemoglobinopathies” refers to a group of genetic conditions that result in the production of abnormal hemoglobin(s) or in the lack of production of normal hemoglobins. The impact of hemoglobinopathies, particularly sickle cell disease, on health care in the United States over time can be measured by the availability of various federal and state public health programs and funding streams that have encouraged the study of these important conditions. As a partial result, universal NBS for hemoglobinopathies is now required in all 50 states and the District of Columbia.†
While all US NBS laboratories test for the hemoglobinopathies, the techniques used, screening algorithms, reporting processes, and confirmatory procedures differ. Comprehensive training and methodological guidance provided by the Centers for Disease Control and Prevention (CDC) during the 1970s through the 1980s and 1990s is no longer available.a Likewise, the NBS laboratory procedures manual published by the American Public Health Association in 1993* and earlier CDC manuals are outdated.
While some CDC assistance is available to laboratories as part of the Newborn Screening Quality Assurance Program, it is not designed to address the laboratory differences previously noted. In the absence of current published guidance on NBS for hemoglobinopathies, a CLSI guideline will provide a needed tool to help in the improvement of NBS processes globally.
This guideline will address the detection of hemoglobinopathies as part of the newborn bloodspot screening process. It is particularly oriented to the screening laboratory processes, including reporting, involved in screening for sickle cell disease and other clinically significant hemoglobin disorders, such as hemoglobin H disease, detectable through NBS.
More information on this new CLSI project can be found here.
*Benson JM, Therrell BL. History and current status of newborn screening for hemoglobinopathies. Sem Perinatol. 2010;34(2):134-44.
†Therrell BL Jr, ed. Laboratory Methods in Neonatal Screening. Washington, D.C.: American Public Health Association; 1993.
The process flow charts for this document can be found here.
Care and treatment of preterm, low birth weight, and sick infants and improvements to newborn screening (NBS) programs have made great advancements, but little is known as to the impact of one on the other. The effects of preterm birth and its associated treatment are partially understood for certain disorders on NBS panels, for example, endocrine disorders, hemoglobinopathies, enzymopathies such as galactosemia, and cystic fibrosis (CF). However, very little is known about most metabolic disorders. Simple questions such as how long parenteral nutrition affects results on amino acid tests are unknown at this time, and this document reflects areas where no data exist. Further research is urgently needed. Because no test has been proven to produce results consistently with 100% sensitivity and specificity, including those used in NBS, practitioners should be reminded to remain vigilant for signs and symptoms associated with screened conditions, even in the presence of normal NBS results.
CLSI document NBS03 addresses best practices for Special Care Baby Unit personnel, as well as primary health care providers, laboratory staff, and follow-up personnel to provide all preterm, low birth weight, and sick infants with valid newborn blood spot and hearing screening. Best practices are defined with consideration of the conditions screened for and timing of screening events. Special circumstances include the condition of the infant, treatments given, maternal conditions/therapies, and other factors.
This revision will update the recommendations of the guideline to complement expansion of NBS since its publication in 2009. Additional information on NBS03 can be found here.
During the development of this guideline, experts in neonatology, NBS, endocrinology, metabolism, hematology, hearing loss, genetics, and CF worked collectively to outline factors that interfere with the reliability of NBS, review the significance and duration of the interference, and provide recommendations for NBS specimen collection, including information on timing and number of specimens. To maintain and strengthen the usefulness of NBS03, we welcome field experts with similar experience and interests.
The CLSI Consensus Committee on Quality Management Systems and General Practices has a goal to develop and maintain one or more guidelines that support each quality system essential (QSE). There is currently no general CLSI guideline that supports the policies, processes, and procedures for QSE Information Management; this guideline will fill that gap.
This guideline will describe regulatory and accreditation requirements for laboratory information that is entered into paper-based and electronic systems, such as patient demographics and examination results, reports, and related information. The guideline will offer ideas on how to manage the related processes and thus help laboratories meet the requirements.
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Today, hospitals, health systems, and accountable care organizations need to leverage interdisciplinary expertise to clinically streamline, target, and optimize diagnostic services, to promote quality patient care and, in fact, survive. An emerging, increasingly common approach pertaining to laboratory tests is the development of guidelines and interventions intended to encourage efficient and effective test utilization, often overseen by an interdisciplinary group, or “test utilization committee.” Laboratory professionals possess, and will be recruited to provide critical expertise to such committees. However, the roles of laboratories, pathologists, and doctoral scientists in such systematic test utilization management are largely unexplored, and their health care organizations’ approach to committee development can be hampered by lack of standardized test utilization committee models, underappreciated resource demands, variable IT capabilities, and simply confusion about how to proceed. A document applying the QSE model, and offering educational content concisely presenting known and potential intervention strategies, operational challenges, and opportunities, will substantially assist laboratorians, physicians, and health care professionals in initiating, operating, and sustaining an effective test utilization program.
Successful completion of a CLSI document is dependent upon the commitment of committee volunteers. Generally, volunteers can expect to spend a minimum of 2 hours per week on CLSI document development or revision activities. Committee chairholders can expect to spend a minimum of 3 hours on committee activities per week during the development or revision phase. Specific timelines have been determined for the Quality projects and the NBS projects. If you are unable to participate in committee activities on the development dates scheduled, please reconsider your nomination.
Committee Roles and Essential Duties
Details on the roles and essential duties of committee participants can be found here.
Requirements for Nomination Consideration
All nominees are required to submit the following documentation in order for their nominations to be considered:
Membership/Administrative Fee Requirement
Payment of an annual administrative fee is required for participation on CLSI committees. If you or your organization is a member of CLSI, the annual fee is included in your membership dues; no additional payment is required. For CLSI nonmembers, upon payment of the administrative fee, you will receive a complimentary Individual Associate Membership. More information on CLSI membership can be found here.
Please submit nominations and required documentation for the quality-related projects on or before 3 April 2015 and for the NBS-related projects on or before 24 April 2015.
Questions? Please contact Stephanie Robinson at firstname.lastname@example.org.
Consensus committee and subcommittee member and advisor appointments are for one year and are made in January. To ensure the continued vitality of the committee and to allow as many CLSI volunteers as are qualified to participate, a portion of the membership of the committee is rotated each year.
Questions? Please contact Stephanie Robinson at email@example.com.
Please check back often as new opportunities are continually added. For specific questions related to volunteering, please contact us at firstname.lastname@example.org.