Chapter 4.3

Guidelines and Regulations, Personnel and Billing and Coding Objectives and Resources

This presentation discusses regulatory information, means of performing quality control and quality improvement, HIPAA, regulatory agencies, CLIA ’88, ASR requirements, reporting, interpretation of results, personnel, proficiency testing, and billing and coding issues for the molecular laboratory. (45 slides)



  • Identify specific quality control measures in the molecular and ISH testing, including interpretation and reporting of test results
  • Describe HIPAA, CLIA and regulatory agencies affecting molecular laboratories
  • Differentiate the approval designations given by the FDA
  • Define ASR and its appropriate quality control measures
  • Discuss requirements for personnel training
  • Identify qualifications for personnel in various job titles
  • Describe CPT coding and regulations related to billing

Resource:  Roche CD, Regulatory - 

This CD reviews the basics of in vitro diagnostics, discusses premarket approval, premarket notification, investigational new drug regulations, investigational use only and research use only regulations, analyte specific reagent regulations, and CLIA.  Important factors for molecular laboratories are also addressed.