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October 2014:

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Click here to see information about laboratories who either perform specimen testing (molecular, immunohistochemistry, traditional reference laboratory testing) or provide second opinions on pathology slides / blocks. Any reference labs that our visitors work for can easily be added by contacting Sara Halladay-Klakulak at 248/646-0325 or PathOutSales@gmail.com.

The Clinical Pathology Laboratory: Current Regulatory Trends
Jaleh Mansouri, M.D.

The increasing complexity of laboratory tests and concerns for patient safety have steered policymakers towards exercising greater oversight in the risk management of medical devices, including in vitro diagnostic (IVD) tests and laboratory instruments. Currently, regulatory policy for medical devices is in a state of transition; however, the Food and Drug Administration (FDA) has focused on implementing strategies for standardizing laboratory instruments and IVD tests in clinical pathology laboratories both in the United States and internationally.

One of these strategies is a requirement by the FDA of a Unique Device Identifier (UDI) for medical devices, including some Laboratory Developed Tests (LDTs). The UDI is a code composed of both a Device Identifier (DI) and Production Identifier (PI). This code provides very specific information about the device, including model, batch/lot number, serial number, expiration date, and production and manufacturing data. The UDI will facilitate the tracking of medical devices in order to reduce misidentification errors in patient care, report adverse events, mitigate counterfeit medical device distribution, and update the Global Unique Device Identification Database (GUDID). The UDI represents one example of the current regulatory trend of standardizing the quality and performance of medical devices in hospitals and clinical laboratories on a more global level.

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ARUP Laboratories. Founded in 1984, ARUP Laboratories is a leading national reference laboratory and an enterprise of the University of Utah and its Department of Pathology. ARUP offers more than 3,000 tests and test combinations, ranging from routine screening tests to esoteric molecular and genetic assays. ARUP serves clients across the United States, including many of the nation's top university teaching hospitals and children's hospitals, as well as multihospital groups, major commercial laboratories, military and other government facilities, and major clinics. In addition, ARUP is a worldwide leader in innovative laboratory research and development. For more information, visit www.aruplab.com.

Cleveland Clinic Laboratories has been providing the highest quality reference laboratory testing for more than 25 years. Today, our staff of board-certified anatomic and clinical pathologists, medical technologists and laboratory technicians provide crucial pathology and laboratory testing services to clients around the corner and across the country. Cleveland Clinic Laboratories operates 24 hours a day, seven days a week. Clients may select from a menu of more than 2,400 routine and esoteric tests. Through the application of leading-edge technology, Cleveland Clinic Laboratories prides itself on providing rapid turnaround time, affordable testing and superior customer service. To find out more about Cleveland Clinic Laboratories please visit us at www.clevelandcliniclabs.com.

Past / Future Feature Pages:

June 2014: Diagnostic Testing / Reagents
July 2014: Digital / Imaging / Photography
August 2014: Books & Journals
September 2014: Antibodies / Biomarkers
October 2014: Laboratories

November 2014: Consumable Lab Products / Clinical Lab Analyzers
December 2014: Grossing Equipment / Workstations
January 2015: Billing / Consulting / Management
February 2015: Microscopes / Microscopy Products
March 2015: Tissue Processors / Other Histology
April 2015: Laboratory Accreditation / Education / CME
May 2015: Computer Software and Systems
June 2015: Diagnostic Testing / Reagents

Contact Sara Halladay-Klakulak, 248/646-0325, pathoutsales@gmail.com to advertise at PathologyOutlines.com, the world's most popular pathology website.

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