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 the following eight courses. Each course can be completed online in approximately 1-2 hours and contains a lecture, readings, resources, and a quiz
Chris Rorick MPA, Bryan Cave LLC, Washington, DC
Provides working knowledge of Federal legislative process, how to advance legislation, and how to identify valuable resources to follow the legislative process.
Regulatory Oversight of Clinical Laboratories
Vincent Stine, PhD, the Association for Diagnostics & Laboratory Medicine (formerly AACC), Washington, DC
Describes the policy process, shares the purpose of regulations, explains how regulations are developed, explains regulatory enforcement, and describes how to influence regulations and regulatory politics.
CLIA ‘88 Regulations and Sources of Information
Sharon Ehrmeyer, PhD, University of Wisconsin Medical School, Madison, WI
Summarizes CLIA’s history (Act versus Amendments), describes CLIA’s role in clinical testing for U.S. laboratories, identifies CLIA’s testing categories and how the categories differ in mandated requirements, explains the role and format of proficiency testing, and discusses the timeframe and purpose of laboratory inspection of non-waived testing.
HIPAA and OSHA Regulations
Daniel Scungio, MT(ASCP), Sentara Healthcare, Norfolk, VA
Explains the purpose of HIPAA regulations and methods of laboratory compliance, describes OSHA standards that affect work in the laboratory setting, explains how to participate in an OSHA investigation.
FDA Regulation of Diagnostic Tests
Steven Binder, Bio-Rad Laboratories, Hercules, CA
Identifies the three classes used by the FDA to define diagnostic products according to their risk and gives examples of each product class that are routinely used in their laboratory, explains how the FDA can establish that a product is "safe and effective" by use of predicate methods or by clinical studies, defines Laboratory Developed Test (LDT), and explains what regulatory body currently has oversight of this type of method.
Charles Root, PhD, Codemap, Schaumburg, IL
Explains the basics of how laboratories are reimbursed for their services, describes how new CPT codes are assigned and priced, and discusses the Medicare payment system for these lab services.
The Protecting Access to Medicare Act of 2014
Charles Root, PhD
Describes how laboratory test payment is set under PAMA, summarizes how new tests are reimbursed, and describes advanced Diagnostic Tests.
Compliance and Medicare Fraud and Abuse Provisions
Gregory Root, Esq, Codemap, Schaumburg, IL
Discusses the basic components of three pieces of legislation (the Federal Anti-Kickback Statute, the Start Self-Referral Prohibitions, and the Beneficiary Inducement Statute) and explains how to recognize and identify potential violations of these statutes and provisions.