Clinical Laboratory Education

Laboratory Director CME Certification (CLR01)

COLA's Laboratory Director CME Certification course will prepare physicians seeking to direct moderate complexity laboratories to meet the CLIA responsibilities for Laboratory Director, promote successful laboratory operations management, and effectively oversee required staff. The course is designed to meet the CMS 20 continuing medical education credit requirement stated in 42 CFR 493.1405(b)(2)(ii)(B) related to CLIA requirements for physician directors of moderate complexity laboratories.

Intended Audience:
Doctors of medicine, osteopathy, or podiatry seeking to fulfill the CLIA requirement at 42 CFR 493.1405(b)(2)(ii)(B) may use the 20 CME credits. If you are not a physician, you cannot qualify as a laboratory director for moderate complexity laboratories by taking this course.

Course Completion:
Select "Buy Now" to access the course materials. The course consists of seven self-paced modules that contain 1-3 individual courses each. There is a post-knowledge quiz after each course for which a score of 80% or higher is required. The course includes a pre and post knowledge assessment to measure knowledge gained in the course. Learners may retake examinations until they achieve a successful score. For the best learning experience, learners must take the modules in order.

Credits Awarded:
The AAFP has reviewed the COLA Laboratory Director CME Certification and has deemed it acceptable for up to 20.00 Enduring Materials; Self-Study AAFP Prescribed credit. The term of Approval is from 11/22/2023 to 11/22/2024. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Regarding this educational activity, all conflicts of interest have been resolved and disclosed below:
Event Planner: Verlin K. Janzen, MD, FAAFP no relevant financial relationships to disclose
Authors: The following authors have no relevant financial relationships to disclose.
Kathy Nucifora, MPH, MT (ASCP)
Danielle Stroughton Duncan, BS, MT, MEd
Susan Densford, BS, MT(ASCP)
Nicole Colby, MLS(ASCP)cm, SBBcm, SCcm
Maurica Price, BS H(ASCP)CM
Kathy Wilson, HT (ASCP)QLS

The educational activity does not discuss unlabeled/unapproved uses of drugs/devices.
  • COLA Laboratory Director CME Course Information
  • Laboratory Director Pretest Assessment
  • Module 1: Introduction
  • Introduction
  • Introduction Quiz
  • Module 2: Laboratory Director General Responsibilities
  • Overview of the Position
  • Overview of Postion Quiz
  • Regulatory Compliance
  • Regulatory Compliance Quiz
  • Module 3 : Quality Control/Quality Assessment Responsibilities
  • Quality Control
  • Quality Control Quiz
  • Quality Assessment Basics
  • Quality Assessment Basics Quiz
  • Individualized Quality Control Plan (IQCP)
  • Individualized Quality Control Plan (IQCP) Quiz
  • Module 4: Procedural Responsibilities
  • Test Systems
  • Test Systems Quiz
  • Procedures
  • Procedures Quiz
  • Preanalytic Phase of Testing
  • Preanalytic Quiz
  • Analytic and Postanalytic Phase of Testing
  • Analytic and Postanalytic Phase Quiz
  • Module 5: Personnel Management Responsibilities
  • Required Positions for Moderate Complexity
  • Required Positions for Moderate Complexity Quiz
  • Training and Competency
  • Training and Competency Quiz
  • General Proficiency Testing Requirements
  • General Proficiency Testing Requirements Quiz
  • Split Specimen Analysis
  • Split Specimen Analysis Quiz
  • Proficiency Testing Failures
  • Proficiency Testing Failures Quiz
  • Bloodborne Pathogens
  • Bloodborne Pathogens Quiz
  • Chemical Hygiene
  • Chemical Hygiene Quiz
  • Physical Plant, Facilities and Environment
  • Physical Plant, Facilities and Environment Quiz
  • Post-test Assessment
  • Laboratory Director Post Assessment
  • Course Feedback
  • Laboratory Director Course Feedback
Completion rules
  • All units must be completed
  • Leads to a certificate with a duration: Forever