This guideline, which is intended for use by NBS clinicians, laboratory personnel, producers of laboratory products related to NBS, and those involved with the oversight of NBS programs, facilitates the incorporation of SCID NBS into the routine operation of existing NBS programs. Methodologically, it focuses on measuring TREC in DBS specimens by real-time quantitative polymerase chain reaction, the method currently in use by all NBS laboratories. Both startup and operating NBS programs benefit from the use of NBS06, which contains detailed protocols for screening and follow-up.

“There is the potential for a cure with early detection of SCID,” said Harry Hannon, PhD, and Roshini Sarah Abraham, PhD, D(ABMLI); Chairholder and Vice-Chairholder of the NBS06-A document development committee. “Newborn screening can save lives from this devastating disorder.”

NBS06 conveys detailed information for laboratory practice, including calibration, quality control, and proficiency testing. It also addresses program issues such as short-term follow-up (ie, notification and tracking to establish or rule out a diagnosis). The guideline includes clinical and immunological background on SCID and other immunodeficiency disorders that may present with low or no TREC content in newborns.

This guideline also boasts several appendixes that showcase information vital to the document, including the first comprehensive tabulation of primary and secondary conditions detected by the TREC assay, and an exemplar generic flow chart for TREC assays in NBS.

SCID NBS is technologically evolving with respect to both laboratory practices and outcome measures. NBS06 provides the foundation for refinements in the future. The participation and close collaboration of all NBS programs is critical to the success of this endeavor.

The Clinical and Laboratory Standards Institute (CLSI) is a not-for-profit membership organization that brings together the varied perspectives and expertise of the worldwide laboratory community for the advancement of a common cause: to foster excellence in laboratory medicine by developing and implementing clinical laboratory standards and guidelines that help laboratories fulfill their responsibilities with efficiency, effectiveness, and global applicability. For additional information, visit the CLSI website at www.clsi.org or call 610.688.0100.

CLSI congratulates all of the 2013 Excellence Award winners:

Excellence in Leadership in Global Health Partnerships
Wilson Mtotela, MLS, MBA, independent laboratory consultant

Raymond Nyakuwocha, MLS, MSc, mentor in six of the zonal laboratories in Tanzania

Excellence in Global Leadership in Standards Development
Donald M. Powers, PhD, President of Powers Consulting Services

Excellence in Consensus Management
James F. Pierson-Perry, Senior Key Expert in the Global Assay Development group of Siemens Healthcare Diagnostics

Excellence in Mentoring in Standards Development
David G. Grenache, PhD, DABCC, FACB, Associate Professor of Pathology at the University Of Utah School Of Medicine, and a medical director at ARUP Laboratories

Excellence in Standards Development
Terry Jo Gile, MT(ASCP); MA.Ed, President of Safety Lady LLC®

James T. Mascarello, PhD, Technical Director at Integrated Genetics

David B. Sacks, MD, Senior Investigator and Chief of Clinical Chemistry at the National Institutes of Health

Barbara Zehnbauer, PhD, FACMG, Chief of the Laboratory Research and Evaluation Branch within the Division of Laboratory Science and Standards in the Office of Surveillance, Epidemiology, and Laboratory Services at the Centers for Disease Control and Prevention

John V. Bergen Award
James H. Nichols, PhD, DABCC, FACB, Professor of Pathology, Microbiology, and Immunology, and Medical Director of Clinical Chemistry at Vanderbilt University School of Medicine

Russell J. Eilers Memorial Award
The highest award presented by CLSI is the Eilers Award, given annually to an individual who has made outstanding contributions to CLSI’s success; the recipient of this award is selected by the CLSI President in consultation with the Executive Committee.
Lucia M. Berte, MA, MT(ASCP)SBB, DLM; CQA(ASQ)CMQ/OE, President of Laboratories Made Better! P.C.

The Clinical and Laboratory Standards Institute (CLSI) is a not-for-profit membership organization that brings together the varied perspectives and expertise of the worldwide laboratory community for the advancement of a common cause: to foster excellence in laboratory medicine by developing and implementing clinical laboratory standards and guidelines that help laboratories fulfill their responsibilities with efficiency, effectiveness, and global applicability. For additional information, visit the CLSI website at www.clsi.org or call 610.688.0100.

There are four new features in QMS02-A6 that were not offered in the previous version. First, is a process for managing the lifespan of documents from development through retirement. The second feature includes detailed descriptions and more examples of laboratory policies, processes, procedures/job aids, and form documents. The third is the provision of concise instructions for how to prepare process flow charts with several useful, generic examples. Finally, the guideline presents more condensed and effective means for manufacturers and laboratories to prepare documents for examinations performed on automated analyzers.

Using flow charts to depict the sequence of activities in laboratory processes, QMS02-A6 describes what laboratories need to do to meet published regulations, accreditation requirements, and international standards for laboratory documents and procedures manuals. In addition, several examples of common laboratory processes and procedures are provided, and serve as valuable starting points for documenting laboratory information.

“For this guideline we took evidence-based advances in more effective writing that have been successfully used in business and industry, and applied them to all types of laboratory documents,” stated QMS02-A6 document Chairholder, Lucia Berte, MA, MT(ASCP)SBB, DLM; CQA(ASQ)CMQ/OE,  President of Laboratories Made Better! P.C. in Broomfield, Colorado, USA. “The result is laboratory policies, processes, and procedures that are easy to read, understand, and use.”

QMS02-A6  is applicable to documents used by medical laboratories of any size, complexity, or specialty,  and is intended for use by administrative and technical personnel who develop laboratory documents, manufacturers, educators, and regulatory and accreditation organizations.

The Clinical and Laboratory Standards Institute (CLSI) is a not-for-profit membership organization that brings together the varied perspectives and expertise of the worldwide laboratory community for the advancement of a common cause: to foster excellence in laboratory medicine by developing and implementing clinical laboratory standards and guidelines that help laboratories fulfill their responsibilities with efficiency, effectiveness, and global applicability. For additional information, visit the CLSI website at www.clsi.org or call 610.688.0100.

A previous CLSI document, GP26-A4—Quality Management System: A Model for Laboratory Services; Approved Guideline—Fourth Edition, outlined the 12 QSEs; however, GP38 comprehensively explains one of these QSEs–Organization. This guideline aims to assist laboratories in meeting the leadership-based requirements for their QMS through three organizational dimensions (ie, cultural, structural, and functional) and provides content to demonstrate the importance of handling laboratory quality.

Proper leadership and management are the keys to implementing and maintaining a QMS. The laboratory’s leadership should be setting the expectation that quality management is the laboratory’s “way of doing business” rather than an added activity. Knowing this information, CLSI produced this guideline’s content with the aim of enhancing the effectiveness of leadership at shaping (ie, designing, implementing, and maintaining) the quality-related aspects of each dimension, thereby supporting leaders in the fulfillment of their QMS roles and responsibilities.

“I have frequently heard laboratory colleagues say that QSE Organization is the least understood of the 12 QSEs,” stated GP38 document Chairholder, Christine Flaherty, MHA, CLS, CPHQ, Regional Director of Sutter Health Sacramento Sierra Region Laboratories in Sacramento, California, USA. “A goal of GP38 is to provide clear and understandable information on how to meet the leadership-based requirements for a QMS.”

GP38 contains abundant information on each leadership-based requirement, as well as useful examples and templates. The guideline was organized so that it can be read cover-to-cover or used as a reference tool. Flaherty noted that the document “will be a ‘must have’ for those who want a single reference covering the roles and responsibilities unique to the laboratory managers and leaders who foster and sustain quality.”

This guideline was not written to be prescriptive, but is meant to provide a suggestive approach in implementing the QSE. GP38 is intended to be used by all organizations and individuals involved in the management or operation of preexamination, examination, and postexamination phases of the medical laboratory. This document may be applicable to other types of laboratories, as well as nonlaboratory settings.

The Clinical and Laboratory Standards Institute (CLSI) is a not-for-profit membership organization that brings together the varied perspectives and expertise of the worldwide laboratory community for the advancement of a common cause: to foster excellence in laboratory medicine by developing and implementing clinical laboratory standards and guidelines that help laboratories fulfill their responsibilities with efficiency, effectiveness, and global applicability. For additional information, visit the CLSI website at www.clsi.org or call 610.688.0100.

M100-S23 includes a dosage regimen for imipenem for Pseudomonas aeruginosa and new information for detection of inducible clindamycin resistance using the D-zone test or broth microdilution for Streptococcus pneumoniae. Also, the disk diffusion and minimal inhibitory concentration quality control frequency has been updated to include a new two-phase, 15-replicate (3 × 5 day) plan and flow chart. Expanded recommendations for testing fluoroquinolones and salmonella, and elimination breakpoints for beta-lactamase, other than oxacillin (cefoxitin), penicillin, and ceftaroline for staphylococci are included.

Jean B. Patel, PhD, D(ABMM), Deputy Director of the Office of Antimicrobial Resistance for the Centers for Disease Control and Prevention in Atlanta, Georgia, USA, and Vice-Chairholder of the CLSI Subcommittee on Antimicrobial Testing Standards, stated that, “There are a number of changes in this latest version of M100, but perhaps the most significant are the new ceftaroline interpretive criteria (or breakpoints) for several bacterial genera including Staphylococcus aureus, the new doxycycline, revised tetracycline breakpoints for Streptococcus pneumoniae, and the simplified Staphylococcus spp. table.”
This January, instantly access M100-S23 with CLSI’s new electronic product. eM100 is an interactive, searchable database for drug selection, interpretation, and QC procedures. Work more efficiently by providing the latest recommendations for detecting emerging resistance in an easy-to-use format. There is a version specifically designed for pharmacists to enhance the implementation of M100 information tailored to their organization.

The Clinical and Laboratory Standards Institute (CLSI) is a not-for-profit membership organization that brings together the varied perspectives and expertise of the worldwide laboratory community for the advancement of a common cause: to foster excellence in laboratory medicine by developing and implementing clinical laboratory standards and guidelines that help laboratories fulfill their responsibilities with efficiency, effectiveness, and global applicability. For additional information, visit the CLSI website at www.clsi.org or call 610.688.0100.

In addition to the webinar, this year there will be an optional post program self-assessment that will allow individuals to assess their knowledge regarding the most important AST and reporting issues for 2013. Laboratories can use this feature to augment competency assessment requirements for their staff.

Webinar information is as follows:

CLSI 2013 AST Update
February 6, 2013 • 1:00–2:30 PM Eastern (US) Time
February 7, 2013 • 3:00–4:30 PM Eastern (US) Time (Repeat Session)

Speaker: Janet A. Hindler, MCLS MT(ASCP), Sr. Specialist, Clinical Microbiology, UCLA Medical Center, Los Angeles, California, USA

Learner Level: Intermediate

At the conclusion of this program, the participant will be able to:
• Identify the major changes found in the new M100-S23.
• Design a strategy for implementing the new practice guidelines into their laboratory practices.
• Develop a communication strategy for informing clinical staff of significant AST and reporting changes.
Register for the upcoming webinars at www.aphl.org/clsi.

APHL is approved as a provider of continuing education programs in the clinical laboratory sciences by the American Society for Clinical Laboratory Science P.A.C.E.® Program. Participants who successfully complete each program will be awarded 1.5 contact hours. P.A.C.E.® is accepted by all licensure states except Florida. Each course has been approved for 1.5 contact hours Florida Laboratory Licensees.

To receive continuing education credit, you must view the program and complete the online evaluation by March 7, 2013.

The Clinical and Laboratory Standards Institute (CLSI) is a not-for-profit membership organization that brings together the varied perspectives and expertise of the worldwide laboratory community for the advancement of a common cause: to foster excellence in laboratory medicine by developing and implementing clinical laboratory standards and guidelines that help laboratories fulfill their responsibilities with efficiency, effectiveness, and global applicability. For additional information, visit the CLSI website at www.clsi.org or call 610.688.0100.