Regulatory

 

Regulatory Policy and Procedures

  •   This TLC program provides a comprehensive set of tools and templates that are easily customizable to facilitate regulatory compliance.

      SOP Manuals

    • Quality Assessment Manual
    • Analytical Procedure Manual
    • Quality Control Manual
    • OSHA Manuals

Inspection Readiness

  •   Facing an onsite laboratory survey can have seasoned laboratory veterans experience anxiety when contacted by a regulatory agency for a routine inspection. This easy to use assessment tool was designed to prepare the user for the survey process by providing information and clarification for each step of the survey These tools were set up to provide guidance to personnel preparing for these surveys. This tool provides information relating to CLIA and COLA inspection and accreditation process.

Information Technology Validation

  •   CLIA, COLA and other accreditation agency’s require laboratories to include validation and ongoing monitoring of their electronic based laboratory data system within their quality assessment program. This tool provides an interpretive overview of the regulatory requirements related to set-up and ongoing management of the Laboratory Information System (LIS) based upon guidelines provided by CLIA and COLA. It addresses installation validation and quality assessment.

Ask the Experts: Do you ever have a question about regulations, quality assurance, proficiency testing or anything laboratory? Ask-the-Exerts is a resource to get answers to your lab questions or concerns. ELITechGroup customers can email tlc@elitechgroup.com and expect a response within one business day.

Lab Essentials Course (Web-based): Lab Essentials is a web-based training course designed to refresh your knowledge of laboratory best practices. You’ll be re-introduced to CLIA regulations and review lab operations from pre-analytic to post-analytic processes. This course is also a great laboratory introduction for those who do not have a laboratory background. Lab Essentials is approved for 4.0 hours of P.A.C.E.® credits.

Proficiency Testing HealthCheck: PT HealthCheck is a TLC service designed to proactively review proficiency test results and identify potential issues and/or assist with corrective action plans, if necessary. If ELITechGroup customers have questions or need assistance with recent PT events, they contact us at 855-ELITECH (855-354-8324) or tlc@elitechgroup.com.

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