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Certificate Program

Regulatory Affairs for Laboratory Compliance Certificate Program

  • Credit: 8.5 ACCENT
  • Level: Beginner

Price: $400.00

Member Price: $200.00

Rating: Member Average


There are very specific conditions under which a clinical laboratory must operate, and this program provides a comprehensive introduction to the many layers of regulatory oversight involved. Participants will learn about the regulations themselves as well as their importance and impact. The program concentrates on federal and state regulations, how CLIA ’88, OSHA, and HIPAA affect laboratory operations, the regulation of diagnostic tests, lab reimbursement, and how to comply with Medicare fraud and abuse provisions.

The program is composed of eight courses listed below. Each can be completed online in 1-2 hours each. Each course contains a lecture, reference materials, and a quiz. Communicate questions or comments using the program discussion board.


  1. Legislative Process
    • Learning Objectives: Gain working knowledge of Federal legislative process; gain working knowledge how to advance legislation; identify valuable resources to follow the legislative process.
    • Speaker: Chris Rorick MPA, Bryan Cave LLC, Washington, DC
  2. Regulatory Oversight of Clinical Laboratories
    • Learning Objectives: Describe the policy process; realize the purpose of regulations; learn how regulations are developed; comprehend regulatory enforcement; describe how to influence regulations and regulatory politics
    • Speaker: Vincent Stine, PhD, AACC, Washington, DC
  3. CLIA ‘88 Regulations and Sources of Information
    • Learning Objectives: Summarize CLIA’s history (Act versus Amendments); describe CLIA’s role in clinical testing for U.S. laboratories; identify CLIA’s testing categories and how the categories differ in mandated requirements; explain the role and format of proficiency testing; discuss the timeframe and purpose of laboratory inspection of non-waived testing.
    • Speaker: Sharon Ehrmeyer, PhD, University of Wisconsin Medical School, Madison, WI
  4. HIPAA and OSHA Regulations
    • Learning Objectives: Explain the purpose of HIPAA regulations and methods of laboratory compliance; describe OSHA standards that affect work in the laboratory setting; understand how to participate in an OSHA investigation.
    • Speaker: Daniel Scungio, MT(ASCP), Sentara Healthcare, Norfolk, VA
  5. FDA Regulation of Diagnostic Tests
    • Learning Objectives: Identify the three classes used by the FDA to define diagnostic products according to their risk, and give examples of each product class that are routinely used in their laboratory; explain how the FDA can establish that a product is "safe and effective" by use of predicate methods or by clinical studies; define Laboratory Developed Test (LDT) and explain what regulatory body currently has oversight of this type of method
    • Speaker: Steven Binder, Bio-Rad Laboratories, Hercules, CA
  6. Laboratory Reimbursement
    • Learning Objectives: The learner will be able explain the basics of how laboratories are reimbursed for their services, describe how new CPT codes are assigned and priced, and discuss the Medicare payment system for these lab services.
    • Speaker: Charles Root, PhD, Codemap, Schaumburg, IL
  7. The Protecting Access to Medicare Act of 2014
    • Learning Objectives: Describe how laboratory test payment is set under PAMA; summarize how new tests are reimbursed; describe advanced Diagnostic Tests.
    • Speaker: Charles Root, PhD, Codemap, Schaumburg, IL
  8. Compliance and Medicare Fraud and Abuse Provisions
    • Learning Objectives: The learner will be able to discuss the basic components of three pieces of legislation (the Federal Anti-Kickback Statute, the Start Self-Referral Prohibitions, and the Beneficiary Inducement Statute) and explain how to recognize and identify potential violations of these statutes and provisions.
    • Speaker: Gregory Root, Esq, Codemap, Schaumburg, IL

Launch Year: 2011
Review Year: 2017
Re-launch Year: 2018
Course Number: 12419