Certificate Program

Regulatory Affairs for Laboratory Compliance Certificate Program 2018

  • Credit: 8.5
  • Level: Beginner

Price: $0.00

Member Price: $0.00


This program is not open for enrollment until January 29.

Earn 11 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, and some include recommended readings. Communicate questions or comments using the program discussion board.

  • Regulatory Oversight
  • Key Federal Laboratory Regulations
  • State and Private Oversight and Resources
  • Compliance and Medicare Fraud and Abuse Provisions
  • Reimbursement for Laboratory Services
  • FDA Regulation of Diagnostic Tests

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

There are very specific conditions under which a laboratory must operate and this program provides a comprehensive introduction to the many layers of regulatory oversight involved. This program is an opportunity for participants to 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, compliance, reimbursement, and the regulation of diagnostic tests.

Participants who complete this certificate program will be able to:

  • Discuss the history of and need for laboratory regulation and CLIA ‘88
  • Describe how regulations are developed and how one can influence their development
  • Discuss CLIA ‘88’s minimum testing requirements
  • List the governmental groups that participate in regulatory oversight and development
  • List the basic components and recognize potential violations of three pieces of fraud and abuse legislation: the Federal Anti-Kickback Statute, the Stark Self-Referral Prohibitions, and the Beneficiary Inducement Statute
  • 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 the FDA classifies diagnostic testing, how a product is deemed “safe and effective” by the FDA, and define laboratory developed tests (LDTs)

These expert faculty and educators contributed to the program development:

Vincent Stine, PhD, Chair
AACC, Washington, DC

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

Robert Murray, PhD, JD
Midwest Diagnostic Pathology, Park Ridge, IL

Charles Root, PhD
Codemap, Schaumburg, IL

Gregory Root, Esq
Codemap, Schaumburg, IL

Steven Binder
Bio-Rad Laboratories, Hercules, CA


Open Enrollment until December 31, 2018
Program Access from January 29, 2018 until July 15, 2019

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

Course Number: 11785

11 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.


1/29/2018 12:00 AM Until 12/31/2018 11:59 PM