Clinical Laboratory Education

Narrated Laboratory Director CME Certification (CLR01A)



COLA's Laboratory Director Certification course will prepare licensed physicians and laboratory professionals to meet the CLIA continuing education requirement for Laboratory Directors, promote successful laboratory operations management and effectively oversee required staff. The course is designed to meet the CMS 20 CME or CEU credit requirement stated in 42 CFR 493 Subpart M, for moderate and high complexity laboratories. As of December 28, 2024, all non-pathologist physicians and laboratory professionals seeking to qualify as directors of moderate or high complexity laboratories will be required to complete a 20 CME or CEU course on the responsibilities of the laboratory director. Experience requirements also apply; see 42 CFR 493, subpart M for details, or contact COLA.

Intended Audience:

Licensed physicians and laboratory professionals seeking to become laboratory directors. Board certified pathologists are not required to take this course in order to serve as a laboratory director, however it may be helpful to them as a refresher on laboratory director responsibilities.

Course Completion:

Select "Buy Now" to access the course materials. The course consists of seven narrated 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 achieving 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.

COLA has applied for approval as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E. ® Program.


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.

  • General Course Information
  • Laboratory Director Pretest Assessment
  • Module 1: Introduction
  • Introduction
  • Introduction Quiz
  • Module 2: Laboratory Director General Responsibilities
  • Overview of the Laboratory Director 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
  • 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 Laboratories
  • Required Positions for Moderate Complexity Quiz
  • Training and Competency
  • Training and Competency Quiz
  • General Proficiency Testing Responsibilities
  • General Proficiency Testing Requirements Quiz
  • Split Specimen
  • 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