Patient care and public health require timely, reliable laboratory testing. However, clinical laboratory professionals rarely know whether patient specimens contain infectious agents, making ensuring biosafety while performing testing procedures challenging. The importance of biosafety in clinical laboratories was highlighted during the 2014 Ebola outbreak, where concerns about biosafety resulted in delayed diagnoses and contributed to patient deaths. This review is a collaboration between subject matter experts from large and small laboratories and the federal government to evaluate the capability of clinical laboratories to manage biosafety risks and safely test patient specimens. We discuss the complexity of clinical laboratories, including anatomic pathology, and describe how applying current biosafety guidance may be difficult as these guidelines, largely based on practices in research laboratories, do not always correspond to the unique clinical laboratory environments and their specialized equipment and processes. We retrospectively describe the biosafety gaps and opportunities for improvement in the areas of risk assessment and management; automated and manual laboratory disciplines; specimen collection, processing, and storage; test utilization; equipment and instrumentation safety; disinfection practices; personal protective equipment; waste management; laboratory personnel training and competency assessment; accreditation processes; and ethical guidance. Also addressed are the unique biosafety challenges successfully handled by a Texas community hospital clinical laboratory that performed testing for patients with Ebola without a formal biocontainment unit. The gaps in knowledge and practices identified in previous and ongoing outbreaks demonstrate the need for collaborative, comprehensive solutions to improve clinical laboratory biosafety and to better combat future emerging infectious disease outbreaks.

Proficiency testing (PT) is a valuable tool for assessing laboratory performance and verifying the accuracy and reliability of test results. Participation is required by the Clinical Laboratory Improvement Amendments (CLIA) of 1988 for each of the microbiology subspecialties (bacteriology, mycobacteriology, mycology, parasitology, and virology), and the regulations include specific PT requirements for each subspecialty. To determine the use and perceived value of PT beyond meeting CLIA requirements, the Centers for Disease Control and Prevention funded a cooperative agreement with the Association of Public Health Laboratories to convene a series of focus groups to query laboratory professionals responsible for PT. The seven focus groups were comprised of 60 laboratory professionals representing large and small clinical laboratories, microbiology subspecialties, and public health. While participants acknowledged the need to perform PT to meet regulatory requirements, many also cited benefits and challenges beyond regulatory compliance.

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations, laboratory testing is categorized as waived (from routine regulatory oversight) or nonwaived based on the complexity of the tests; tests of moderate and high complexity are nonwaived tests. Laboratories that perform molecular genetic testing are subject to the general CLIA quality systems requirements for nonwaived testing and the CLIA personnel requirements for tests of high complexity. Although many laboratories that perform molecular genetic testing comply with applicable regulatory requirements and adhere to professional practice guidelines,specific guidelines for quality assurance are needed to ensure the quality of test performance. To enhance the oversight of genetic testing under the CLIA framework,CDC and the Centers for Medicare & Medicaid Services (CMS) have taken practical steps to address the quality management concerns in molecular genetic testing,including working with the Clinical Laboratory Improvement Advisory Committee (CLIAC). This report provides CLIAC recommendations for good laboratory practices for ensuring the quality of molecular genetic testing for heritable diseases and conditions. The recommended practices address the total testing process (including the preanalytic,analytic,and postanalytic phases),laboratory responsibilities regarding authorized persons,confidentiality of patient information,personnel competency,considerations before introducing molecular genetic testing or offering new molecular genetic tests,and the quality management system approach to molecular genetic testing. These recommendations are intended for laboratories that perform molecular genetic testing for heritable diseases and conditions and for medical and public health professionals who evaluate laboratory practices and policies to improve the quality of molecular genetic laboratory services. This report also is intended to be a resource for users of laboratory services to aid in their use of molecular genetic tests and test results in health assessment and care. Improvements in the quality and use of genetic laboratory services should improve the quality of health care and health outcomes for patients and families of patients.

The Clinical Laboratory Improvement Advisory Committee (CLIAC) was mandated by the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and established in 1992 to provide advice to the Department of Health and Human Services on regulation of laboratory testing and improving laboratory quality. Since then, CLIAC has met regularly and recommended regulatory changes to CLIA, provided input on good laboratory practices, and discussed critical issues related to clinical and public health testing, the laboratory workforce, and laboratory systems research. The Committee has been effective in driving changes to microbiology quality control, which have led to a decreased burden and lower laboratory costs without sacrificing quality. The issues CLIAC addresses are complex and sometimes controversial, yet members have said their time on the Committee is worthwhile and that CLIAC has a positive influence on laboratory medicine. This Committee will remain a vital resource for providing guidance as laboratory testing continues to evolve. copyright 2009 Elsevier Inc. All rights reserved.