Regulatory affairs for laboratory compliance certificate program

Program description

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.

Target audience

Lab Supervisors, Lab Directors (and/or assistant directors), Lab Managers (supervisory and/or non-supervisory)

Learning objectives

• Provide working knowledge of Federal legislative process, how to advance legislation, and how to identify valuable resources to follow the legislative process.
• Describe the policy process, the purpose of regulations, how regulations are developed, regulatory enforcement, and how to influence regulations and regulatory politics.
• Summarize CLIA’s history (Act versus Amendments), describe CLIA’s role in clinical testing for U.S. laboratories, identify CLIA’s testing categories and how the categories differ in mandated requirements, explain the role and format of proficiency testing, and discuss the timeframe and purpose of laboratory inspection of non-waived testing.
• Explain the purpose of HIPAA regulations and methods of laboratory compliance, describe OSHA standards that affect work in the laboratory setting, explain how to participate in an OSHA investigation.
• Identify 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, explain how the FDA can establish that a product is "safe and effective" by use of predicate methods or by clinical studies, define Laboratory Developed Test (LDT), and explain what regulatory body currently has oversight of this type of method.
• Explain the basics of how laboratories are reimbursed for their services, describe how new CPT codes are assigned and priced, and discuss the Medicare payment system for these lab services.
• Discuss the basic components of three pieces of legislation (the Federal Anti-Kickback Statute, the Start Self-Referral Prohibitions, and the Beneficiary Inducement Statute) and explain how to recognize and identify potential violations of these statutes and provisions.

Courses & faculty

The program is composed of the following seven courses. Each course can be completed online in approximately 1-2 hours and contains a lecture, readings, resources, and a quiz.

1. Legislative Process
   Chris Rorick, MPA, Bryan Cave LLC, Washington, DC
2. Regulatory Oversight of Clinical Laboratories
   Vincent Stine, PhD, the Association for Diagnostics & Laboratory Medicine (formerly AACC), Washington, DC
3. CLIA ‘88 Regulations and Sources of Information
   Sharon Ehrmeyer, PhD, University of Wisconsin Medical School, Madison, WI
4. HIPAA and OSHA Regulations
   Daniel Scungio, MT(ASCP), Sentara Healthcare, Norfolk, VA
5. FDA Regulation of Diagnostic Tests
   Steven Binder, Bio-Rad Laboratories, Hercules, CA
6. Laboratory Reimbursement
   Charles Root, PhD, Codemap, Schaumburg, IL
7. Compliance and Medicare Fraud and Abuse Provisions
   Gregory Root, Esq, Codemap, Schaumburg, IL

Disclosures

The Association for Diagnostics & Laboratory Medicine (formerly AACC) is dedicated to ensuring balance, independence, objectivity, and scientific rigor in all educational activities. All participating planning committee members and faculty are required to disclose to the program audience any financial relationships related to the subject matter of this program. Disclosure information is reviewed in advance in order to manage and resolve any possible conflicts of interest. The intent of this disclosure is to provide participants with information on which they can make their own judgments.

The following planners and faculty reported no relevant financial relationships:

• Chris Rorick, MPA
• Vincent Stine, PhD
• Sharon Ehrmeyer
• Daniel Scungio, MT(ASCP)
• Steven Binder
• Charles Root, PhD
• Gregory Root, Esq

Content validity

All recommendations involving clinical medicine are based on evidence accepted within the profession of medicine as adequate justification for their indications and contraindications in the care of patients; AND/OR all scientific research referred to or reported in support or justification of a patient care recommendation conforms to generally accepted standards of experimental design, data collection, and analysis.

Accreditation statement

This activity is approved for 7.5 ACCENT^® continuing education credits. Activity ID# 4484. This activity was planned in accordance with ACCENT Standards and Policies.

Successful completion statement

Verification of Participation certificates are provided to registered participants based on completion of the activity, in its entirety, and the activity evaluation. The evaluation link will be emailed to the participants after all work within ADLM’s learning platform is complete. For questions regarding continuing education, please email [email protected].

Program Launch Year: 2011
Most Recent Program Update: 2023