CN Quality Assurance & Standards 3 — Questions and Answers
Question 1: A supplement label claims a product 'supports immune health.' Under DSHEA, this structure/function claim must be accompanied by what?
- An FDA disclaimer stating the claim has not been evaluated by the FDA (Correct answer)
- A physician's signature
- A clinical trial registry number
- USDA organic certification
Correct answer: An FDA disclaimer stating the claim has not been evaluated by the FDA
Structure/function claims require the disclaimer that the FDA has not evaluated the statement and the product is not intended to diagnose, treat, cure, or prevent disease.
Question 2: Which quality improvement model uses the cycle of Plan, Do, Study, Act to refine nutrition care processes?
- PDSA cycle (Correct answer)
- SWOT analysis
- SOAP notes
- RACI matrix
Correct answer: PDSA cycle
The PDSA (Plan-Do-Study-Act) cycle is a continuous quality improvement framework for testing and refining process changes.
Question 3: A nutritionist selects laboratory partners for micronutrient testing. Which accreditation indicates the lab meets federal clinical testing quality standards?
- CLIA certification (Correct answer)
- LEED certification
- ISO 14001
- Energy Star rating
Correct answer: CLIA certification
CLIA (Clinical Laboratory Improvement Amendments) certification is the federal standard ensuring quality for clinical laboratory testing on human specimens.
Question 4: To maintain certification, most certified nutritionist credentials require what on a recurring basis?
- Completion of approved continuing education units (Correct answer)
- Retaking the original college coursework
- Publishing peer-reviewed research annually
- Employer sponsorship letters
Correct answer: Completion of approved continuing education units
Recertification typically requires documented continuing education units within each renewal cycle to ensure current competency.
Question 5: A client brings in an imported herbal product with no lot number or expiration date. The nutritionist should recognize this as a red flag for what?
- Poor manufacturing quality control and traceability (Correct answer)
- Superior potency
- Automatic FDA approval
- Extended shelf stability
Correct answer: Poor manufacturing quality control and traceability
Missing lot numbers and expiration dates indicate the product lacks basic quality control and cannot be traced in a recall.
Question 6: Which entity primarily regulates false or misleading advertising of dietary supplements in the United States?
- Federal Trade Commission (FTC) (Correct answer)
- Environmental Protection Agency (EPA)
- Department of Labor (DOL)
- Federal Communications Commission (FCC)
Correct answer: Federal Trade Commission (FTC)
The FTC has primary authority over supplement advertising claims, while the FDA oversees labeling.
Question 7: A nutrition clinic tracks the percentage of clients receiving a documented follow-up within 30 days. This metric is an example of what?
- A process indicator in quality assurance (Correct answer)
- A structure/function claim
- An outcome guarantee
- A dietary reference intake
Correct answer: A process indicator in quality assurance
Measuring whether follow-ups occur on schedule evaluates the care delivery process, making it a process indicator.
CN Quality Assurance & Standards 3
A supplement label claims a product 'supports immune health.' Under DSHEA, this structure/function claim must be accompanied by what?