American Association for Clinical Chemistry
Improving healthcare through laboratory medicine
Regulatory Affairs for Laboratory Compliance Certificate Program

Regulatory Affairs

REGULATORY AFFAIRS
FOR LABORATORY COMPLIANCE 
CERTIFICATE PROGRAM

PROGRAM COURSES

Available for sale: January 1, 2012
Sold Until: December 31, 2012
Program Access Available: January 1, 2012-July 15, 2013

The program is composed of five courses which can be completed online in 1-4 hours each. Each course contains a lecture, required reading, and a quiz, and may include case studies, practical exercises, a glossary, and resource materials. You can earn 10 continuing education units for completing the entire program. The five courses that make up this certificate program are:

  • Regulatory Oversight
  • Key Federal Laboratory Regulations
  • State and Private Oversight and Resources
  • Compliance and Medicare Fraud and Abuse Provisions
  • Reimbursement for Laboratory Services

INTRODUCTION

Federal, state, and private regulations affect laboratory reimbursement and compliance. There are very specific conditions under which your laboratory must operate and this program provides a comprehensive introduction to the many layers of regulatory oversight involved. 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

PROGRAM OVERVIEW

There are many regulations that affect laboratory management and operations. This program is an opportunity for participants to learn about the regulations themselves as well as their importance and impact.

AACC developed this five-course certificate program as a resource for laboratory professionals with an interest in learning more about regulations. The program concentrates on federal and state regulations, how CLIA ’88, OSHA, and HIPAA affect laboratory operations, compliance, and reimbursement. The expert faculty are experienced educators who have extensive knowledge of laboratory regulations and the associated issues.