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Certificate Program

Regulatory Affairs for Laboratory Compliance Certificate Program 2018

  • Credit: 8.5
  • Level: Beginner

Price: $400.00

Member Price: $200.00


Earn 8.5 ACCENT® continuing education credits and a certificate of completion for successfully completing the program before the access end date.

The program is composed of six 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.

  • The Legislative Process
  • Regulatory Oversight of Clinical Laboratories
  • CLIA '88 Regulations and Sources of Information
  • HIPAA and OSHA Regulations
  • FDA Regulation of Diagnostic Testing
  • Lab Reimbursement
  • The Protecting Access to Medicare Act of 2014
  • Compliance with Medicare Fraud and Abuse Provisions

Certificates of completion are awarded online upon successful completion of the program. Graduates are recognized on a register located on the certificate program web page.

Please note that the completion of an online certificate program should be listed within the education section of a resume or CV. It is not equivalent to completing a board certification process.

Speaker Presentation Description

Launch Year: 2011
Review Year: 2017
Re-launch Year: 2018

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.

Participants who complete this certificate program will be able to:

  • Discuss the stages of the legislative process
  • Identify the role of politics in the development of regulations
  • Discuss the history for laboratory regulation and CLIA ‘88
  • Discuss CLIA ‘88’s minimum testing requirements
  • Explain the role and format of proficiency testing
  • Describe the purpose of HIPAA and OSHA regulations
  • Describe how the FDA classifies diagnostic testing, determines “safe and effective” products, and defines laboratory developed tests (LDTs)
  • Explain how laboratories are reimbursed for their services, how CPT codes as assigned and priced, and the Medicare payment system for lab services
  • Describe how new tests are reimbursed under PAMA
  • Recognize potential violations of the Federal Anti-Kickback Statute, the Stark Self-Referral Prohibitions, and the Beneficiary Inducement Statute

These expert faculty and educators contributed to the program development:

Chris Rorick
Bryan Cave LLC, Washington, DC

Vincent Stine, PhD, Chair
AACC, Washington, DC

Sharon Ehrmeyer, PhD
University of Wisconsin Medical School in Madison, WI

Daniel Scungio, MT(ASCP)
Sentara Healthcare, Norfolk,VA

Steven Binder
Bio-Rad Laboratories, Hercules, CA

Charles Root, PhD
Codemap, Schaumburg, IL

Gregory Root, Esq
Codemap, Schaumburg, IL


Open Enrollment until December 31, 2018
Program Access until July 15, 2019

Fee: $200 AACC Member/$400 Non-member

Course Number: 11785

8.5 ACCENT® continuing education credit

  • If you purchase the program on our website, order processing is immediate.
  • If you purchase the program over the telephone, order processing will take 3-4 business days.
  • If you purchase the program via US Post or fax, please allow 2 weeks for order processing.
  • In all cases, program access information will be sent in an email titled AACC Order Confirmation once the order process is complete. Haven’t received your access information? We recommend checking your Spam/Junk Mail in case the confirmation email is filtered there. If you cannot locate the email, please contact AACC Customer Service.


ACCENT® credit is offered. AACC is an approved provider of continuing education for clinical laboratory scientists in the states of California, Florida, Louisiana, Montana, Nevada, North Dakota, Rhode Island, and West Virginia.


You must have Internet access and Internet browser software installed on your computer to view the e-learning materials in this course, as well as Adobe Reader. We recommend the following Internet browsers and browser settings.

  • Internet Explorer version 11 or higher
  • Mozilla Firefox version 33 or higher
  • Google Chrome version 36 or higher
  • Apple Safari version 6 or higher


You will need speakers attached to your computer to hear the audio files associated with some of the course materials.


For best viewing, your screen resolution should be 1024 x 768 or higher.


Cancellations and refunds are not available for e-learning courses.


1/22/2018 12:00 AM Until 12/31/2018 11:59 PM