Regulatory Affairs for Laboratory Compliance

Regulatory Affairs 



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


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, PhD
    Bio-Rad Laboratories, Hercules, CA

Developed in cooperation with the AACC Management Sciences and Patient Safety Division.


Open Enrollment until December 31, 2014
Program Access from January 1, 2014 until July 15, 2015

Fee: $200 AACC Member/$400 Non-member
Course Number: 8729
11 ACCENT® continuing education credits

  • If you purchase the program on our website, processing is immediate and the login information will be on your AACC Web Orders confirmation email.
  • If you purchase the program over the telephone, order processing will take 3-4 business days. Access information will be emailed to you upon enrollment.
  • If you purchase the program via US Post or fax, please allow 2 weeks for order processing.
  • Haven’t received your access information? 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.

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