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Managing CLIA Compliance Costs: 6 Mistakes Every Laboratory Should Avoid

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White Paper 1 Managing CLIA Compliance Costs: 6 Mistakes Every Laboratory Should Avoid "Compliance" is a key process for life science, high-tech companies and for public business. Life science companies specifically must answer to the FDA's compliance regulations as well as to other regulatory bodies' standards and regulations specific to their geographical region. For instance, clinical testing laboratories that wish to perform testing within the United States must comply with the Clinical Laboratory Improvement Act (CLIA) requirements which help improve the accuracy, safety, and efficacy of testing processes within clinical laboratory environments. How Expensive is Compliance? Complying with CLIA and/or GCP regulations costs clinical laboratories a "pretty penny" and every cent is allegedly worth the trouble. However, it isn't uncommon for the expenditures appropriated in the name of compliance to be unnecessarily extravagant. Listed below are six common problems that clinical testing laboratories should avoid (for their pocketbook's sake) when seeking compliance with CLIA regulations. Mistake #1: Spending Too Much on Documentation Management Costs CLIA Section 493.1200 specifies that documentation of quality procedures/ policies must be actualized and that systemic laboratory compliance processes must reflect a laboratory's documentation. Most clinical testing laboratories manage documentation well enough but often spend far more time than is necessary to do so. For example, a lab worker may, according to policy, be required to document five phases of a specified test and give the information to his or her supervisor. The supervisor however will likely be out of the office for much of the work day and his or her absence will inevitably create a delay in the routing of essential documentation. The problem with this touch-and-go method of document management/routing is that it is common for documentation to be left incomplete, to become lost or to become unnecessarily delayed. The utilization of hybrid electronic systems that consist of an e-mail client and a word processing application also commonly result in incomplete, lost or delayed documentation. In addition, the manual archival and retrieval of documents into filing cabinets or desktop computers cost laboratories wasted man hours and--worst of all--manual routing practices often result in lost or out-of-date documentation that can lead to serious errors in clinical laboratory practice. The Solution To control documentation with more cost effective means, clinical testing laboratories need only invest in an automated web-based document control solution. Looking for solutions that provide the following features and benefits is recommended for CLIA-regulated laboratories:

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