In October of 2011, CLSI published a new guideline EP23A on “Laboratory Quality Control Based on Risk Management. In March, 2012, CMS announced its intention to incorporate key concepts from EP23A into its Interpretative Guidelines and QC policy for “Individualized Quality Control Plans. Thus begins a new era of Quality Control in the Age of Risk Management. This issue is intended to help laboratories with the transition between traditional QC practices and the new risk management approach. Laboratories face a steep learning curve to apply risk analysis for identifying and prioritizing failure-modes, developing and implementing control mechanisms to detect those failure-modes, and assessing the acceptability of the residual risks that exist after implementation of a QC Plan. One of the main benefits of the new risk analysis based QC Plans should be an integration of all the control mechanisms that are needed to monitor the total testing process, including pre-analytic, analytic, and post-analytic controls. One of the main risks of the new approach is an expectation that Statistical QC is no longer important, even though SQC still remains the most useful and flexible approach for monitoring the quality of the analytic process. The key to the future is the successful integration of all these control mechanisms to provide a cost-effective quality system that monitors all phases of the total testing process. This issue should help laboratories understand the evolution of QC practices to include risk management, but also to recognize the need to maintain traditional techniques such as Statistical QC, especially during the transition to well-designed and carefully-validated QC Plans. Risk analysis may be risky business unless laboratories proceed carefully and cautiously.

This issue of Clinics in Laboratory Medicine entitled “Risk, Error and Uncertainty: Laboratory Quality Management in the Age of Metrology will be guest edited by Sten Westgard, James Westgard, and David Armbruster. The issue will cover a broad range of topics related to management in the laboratory including but not limited to: Metrology Perspectives; Biologic Variation Approach to Daily Laboratory; Clinical Outcome Approach to Goal Setting; Six Sigma Quality Management System; Traceability and Comparability; MU, Risk, and Sigma-metrics at Sunway; and Quality Indicators for the Total Testing Process, among others.

This issue of Clinics in Laboratory Medicine, titled Toxicology Testing, includes the following topics; Progress in Clinical Toxicology Testing, The Prescription Drug Abuse Epidemic, Substance Abuse Among Healthcare Professionals, Pain Management Drug Testing, Ethanol Biomarkers, Newly-emerging Drugs of Abuse, Synthetic Cannabinoids, Synthetic Cathenones, Immunoassay Methodology in Drugs-of-abuse Testing, Toxicology Testing in Alternative Specimen Matrices, Principles and Procedures in Postmortem Toxicology, and Pharmacogenetics and the Future of Toxicology Testing. Advances in toxicology testing are paving the way for major improvements in the way scientists evaluate health risks posed by toxic chemicals. Toxicity tests help scientists better understand how the human body carries out normal functions that are key to maintaining health. Therefore, this topic is important to the field of Laboratory Medicine.

This issue of Clinics in Laboratory Medicine titled, "Conceptual Advances in Pathology" addresses the key factors impacting pathology and details the technology surrounding the field. The Guest Editor, Zoltan Oltvai, MD., splits the issue into three sections; Technological Advances, Process Advances, Educational and Practice Needs, and the Business of Pathology.

This issue focuses on three disease sections: Diabetes, Hematology and Coagulation, and covers diagnostic and management issues during pregnancy of selected topics in each section. The chapters cover new concepts, evolving management and important impacts on the mother and unborn child.

Molecular pathology has significantly matured over the past decade to establish itself as a discipline in its own right. Patient diagnosis, prognosis, management and care have been influenced by molecular pathology testing algorithms on a global scale. Whether it pertains to carrier status of deleterious genes, diagnosis by molecular techniques, assessment of appropriate remission post treatment, parentage or forensics testing – molecular pathology continues to increase its presence and influence in the diagnostic laboratory armamentarium. Furthermore, intellectualization and proprietization of molecular pathology with respect to the discovery of new genes and or new techniques continues to pose new challenges of test ownership, legalities, liabilities, widespread acceptance and utility. This issue of Laboratory Clinics seeks to provide selective state of the art understanding of molecular pathology with respect to its relationship to key pathology disciplines as well as the current challenges and promise for the future.

The field of Clinical Microbiology is evolving at a rapid pace, perhaps more so than any other arm of laboratory medicine. This can be attributed to new technology, including high throughput gene sequencing, multiplex molecular assays, rapid evolution of antimicrobial resistance, and discovery of new pathogens. In addition, modern medical procedures, such as solid organ and stem cell transplantation, have resulted in an explosion of infections with agents that historically have been considered to be of low virulence. This issue of Clinics in Laboratory Medicine will highlight some of the advances in diagnostic microbiology, including MALDI-TOF MS, pathogen discovery, and personalized antimicrobial chemotherapy. In addition, one of the papers will focus on implementation of new technologies and how to maximize patient impact of these new methods.