EDUCATIONAL, AND TRAINING REQUIREMENTS FOR A LABORATORY DIRECTOR UNDER CLIA? No, in addition you must meet the regulatory responsibilities outlined below. Board of Directors, Personnel Requirements in CLIA Laboratories. The Laboratory Certification Program works to ensure Ohioans receive accurate, cost-effective clinical laboratory testing as a part of their health care. The medical director has the knowledge and skills in all areas of practice which includes administration, teaching and education, research, and patient care. My Consultant Central, Member Login: Qualified Lab Director or Technical Supervisor of high complexity testing . COLA Resources Inc. (CRI) Symposium for Clinical Laboratories: Three day meeting with national speakers and exhibits containing laboratory equipment. A moderate complexity lab may perform all levels of testing up to and including moderate level tests. COLA is the leading private accreditor of clinical labs in the US. The Laboratory Director CME Program allows Physicians to qualify as the director of a moderate complexity laboratory under the Clinical Laboratory Improvement Amendments (CLIA) requirement at 42 CFR 493.1405 (b) (2) (ii) (B). PhDs, PAs, nurses and nurse practitioners may take these courses for CME credit, but the program will not confer qualification as a laboratory director. CMS Top 10 Standard-Level Deficiencies in 2015 2 The Laboratory Director CME Program allows Physicians to qualify as the director of a moderate complexity laboratory under the Clinical Laboratory Improvement Amendments (CLIA) requirement at 42 CFR 493.1405(b)(2)(ii)(B). credit. The following list of required laboratory practices and documents is an overview of what the on-site survey inspection may consist off; however, please know that additional documents may be As defined in CLIA, the laboratory director is responsible for the overall operation and administration of the laboratory. You must demonstrate active involvement in the laboratory’s operation and be available to the laboratory staff, as needed. Credit approval includes the following session(s): AAFP Prescribed credit is accepted by the American Medical Association as equivalent to AMA PRA Category 1 Credit™ toward the AMA Physician’s Recognition Award. OR1 year lab training or experience in high complexity microbiology with a minimum of 6 months in subspecialty of service. Learn More. 1. Visit: A laboratory director must have an MD, DO, DPM, PhD, or must have commensurate CRI Lab Director CME Program: On-line laboratory director CME course program. laboratory training/experience consisting of: a. Participants have access to the course material for three years from date of purchase, allowing it to be used as a resource after completion. LabUniversity: COLA’s Laboratory Director Program and other Continuing Education courses. This Program contains eight online CME courses, in a flexible, self-paced format. The section of the federal regulations titled “Standards and Certification: Laboratory Requirements” is issued by the Centers for Medicare & Medicaid Services (CMS) to enact the CLIA law passed by Congress (see below). •A laboratory director is allowed to oversee up to 5 different CLIA laboratories ©2018 MFMER | 3793435-6 Technical Supervisor High complexity testing •The Technical Supervisor role is applicable only to laboratories that perform high complexity testing •Responsible for the technical and scientific oversight of the laboratory Master’s degree in laboratory science* AND2 years lab training or experience in high complexity microbiology with a minimum of 6 months in subspecialty of service. 3. The Certificate of Compliance and Certificate of Accreditation authorizes a high complexity laboratory to perform all levels of testing. Qualifications of the director may differ based on the type and complexity of the testing performed. In these instances, both we and CMS are notifying the involved director of the need to divest directorship so that they direct only a maximum of five laboratories.We ask all our Laboratory Directors to please keep this CLIA regulation in mind when they agree to become director of an additional laboratory. Complete our online clia application online to start your clia accreditation process ... COLA’s goal is to help you meet CLIA and state regulatory requirements and maintain the highest level of patient care at your clinical laboratory… Laboratories performing only waived tests must follow the manufacturer's instructions (procedures) when performing the tests. The medical director of the laboratory is a suitably qualified physician who is legally, morally, and ethically responsible for the scope, standards, and quality of service. Center Medical Director at CSL Behring - Job Description Serves as the primary physician for reporting to the Food and Drug Administration and in such capacity provides medical 1. For the best learning experience, complete the courses in the order shown below. Physicians completing the program will earn 20 CME credits that meet CLIA requirements and quality systems standards in the areas of laboratory practice and director responsibilities. You will save $90 off the regular price of $290 for the Laboratory Training Program, which provides the same content as the LD CME Program. The fourth chapter, “Waived, PPM, Moderate- and High-Complexity Near Patient Testing Matters In some cases, the deficiency refers to the laboratory director, but the technical consultant supervisor and testing personnel also appear on the list. Do You Meet CLIA Requirements? © 2018 CRI - COLA Resources, Inc. All Rights Reserved. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Leading Excellence in Laboratory Medicine, Phlebotomy Continuing Education Programs and Courses, Webinar CEexpress 26: Quality Laboratory Practice in the Pre-analytic Phase, Verification of Performance Specifications, Best Practices for Performing Waived Tests, 4.50 Enduring Materials, Self-Study AAFP Prescribed Credit(s) – Quality Control for the Laboratory, 3.00 Enduring Materials, Self-Study AAFP Prescribed Credit(s) – OSHA Requirements for the Medical Laboratory, 2.00 Enduring Materials, Self-Study AAFP Prescribed Credit(s) – CLIA ’88 Requirements for the Medical Laboratory, 3.00 Enduring Materials, Self-Study AAFP Prescribed Credit(s) – Laboratory Personnel Requirements, 1.00 Enduring Materials, Self-Study AAFP Prescribed Credit(s) – Laboratory Director Responsibilities, 1.50 Enduring Materials, Self-Study AAFP Prescribed Credit(s) – Quality Assessment Basics, 3.50 Enduring Materials, Self-Study AAFP Prescribed Credit(s) – Proficiency Testing, 1.50 Enduring Materials, Self-Study AAFP Prescribed Credit(s) – Competency Assessment. 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