As the world’s leading health care diagnostics company, LabCorp, based in Burlington, North Carolina, provides comprehensive clinical laboratory services and end-to-end drug development support. LabCorp’s mission is to improve health and improve lives by delivering world-class diagnostic solutions, bringing innovative medicines to patients faster, and developing technology-enabled solutions to change the way care is provided. By providing physicians, hospitals, and other health care providers with accurate, reliable data in a timely fashion and pioneering new, cutting-edge clinical procedures, LabCorp plays a critical role in the process of diagnosing, monitoring, and treating diseases through examination of blood, tissue, and other types of specimens.
LabCorp offers an industry-leading test menu of more than 4,700 tests, ranging from simple blood chemistry analyses to sophisticated techniques involving the replication and highly complex analysis of DNA. LabCorp provides a comprehensive range of specialty testing services in the areas of allergy, diagnostic genetics, women’s health, cardiovascular disease, infectious disease, endocrinology, oncology, coagulation, pharmacogenetics, toxicology, and pain management. Through the LabCorp Specialty Testing Group, its focused specialty labs perform esoteric testing, cancer diagnostics, and other complex procedures, providing physicians with a high level of disease understanding. Each specialty laboratory has a distinctive, long-standing reputation for scientific expertise, innovation, and quality.
LabCorp consists of a network of 39 primary laboratories and approximately 1,700 patient service centers, along with a network of branches and stat labs that offer a focused menu of frequently ordered tests that can be quickly performed and reported back to the physician. With clinical laboratory services across the United States and other countries, including Canada, the United Kingdom, and the United Arab Emirates, LabCorp processes tests on approximately 500,000 patient specimens daily for more than 220,000 customers, including physicians, hospitals, managed care organizations, governmental agencies, employers, and independent clinical laboratories.
Why do you feel it is important to support CLSI?
CLSI documents serve as a resource for enhancing understanding of regulatory requirements under the Centers for Medicare & Medicaid Services Clinical and Laboratory Improvement Amendments and the various quality system elements. Written by colleagues within the profession who understand the challenges of a laboratory, CLSI documents present examples of how to perform certain functions and provide a platform for determining how best to accomplish those functions locally. In addition, the information on antimicrobial susceptibility testing (AST) helps to standardize practice.
CLSI also offers informative webinars. The EP23 online workshop has been a great tool for implementing laboratory quality control as outlined in CLSI’s quick reference guide, EP23, and the Laboratory Quality Management System (LQMS) and Cost of Quality (CoQ) in the laboratory certificate programs fill a need within the laboratory industry.
Which CLSI committees have LabCorp employees served on?
Several individuals from LabCorp have served and continue to serve in different capacities on various CLSI committees. Our employees have chaired the Hematology Subcommittee, as well as the Quality Management Systems Subcommittee through its various iterations. In addition, we are active during document development and revisions as chairholder, vice-chairholder, members, advisors, and/or contributors. Some of the documents in which LabCorp has been represented include The Key to Quality™, Determination of Coagulation Factor Activities Using the One-Stage Clotting Assay (H48), Quantitative D-dimer for the Exclusion of Venous Thromboembolic Disease (H59), Nonconforming Event Management (QMS11), Quality Management System: Leadership and Management Roles and Responsibilities (QMS14), and Assessments: Laboratory Internal Audit Program (QMS15).
How would LabCorp volunteers describe their experiences?
Among individuals who have served as volunteers on CLSI subcommittees and documents, several recurring themes have been expressed. The first is that the experience is educational and rewarding. As one individual responded, “The experience was very educational, as discussions between committee members of varying backgrounds (eg, industry, regulatory agencies, pharmaceutical companies, manufacturers, hospitals, CROs) clearly illustrate the need for a consensus document as well as the need for standardizing terminology.” Another stated, “It’s great to see the consensus process in action. I try to apply that same consensus process to the procedures and policies we develop for my laboratory.” The second recurring theme is how volunteering for CLSI subcommittees and documents contributes to the profession and helps shape better practices in the laboratory industry. The final theme is the interactions with colleagues that volunteering provides. Relationships are built among the various committee members, who become professional colleagues and even personal friends.
What is a unique way that the organization has taken advantage of membership benefits?
The documents available through eCLIPSE, CLSI’s online library, have been an invaluable source of information and guidance, providing additional insight into regulatory and accreditation requirements. These documents also provide valuable training, most notably around quality system elements such as nonconforming events and continual improvement.
Which features of the upgraded eCLIPSE platform do you find most beneficial?
The layout of the home page makes finding a document easier. Documents are already grouped by discipline and can be located by number, which is helpful when someone refers to the document by number only. The key word search and the ability to search by specific text facilitate document retrieval. Being able to create an individual library and using the bookmark to keep track of specific content is a benefit for individual users and allows quick reference to frequently used materials.
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