Domain VIII: Regulatory

Question 1

You must provide the patient with enough information so that he or she can make a
reasonable decision (Risks of procedure, including loss of vision, Complications)

Answer 1

Principles of Informed Consent

Question 2

To frankly answer questions about the risk. To disclose alternative procedures available
and their risks.

Answer 2

Duty of Disclosure

Question 3

After the finished fitting, the Rx must be provided even if the patient does not ask for it
Contact lens verification must be made within 8 hours

Answer 3

FCLCA - Fairness to Contact Lens Consumers Act

Question 4

monitors products not regulated

Answer 4

FDA-Food and Drug Administration

Question 5

Investigates price fixing, and unfair methods in competition
In the ophthalmic industry the greatest impact was in 1978 regarding “Prescription
Release Rule”

Answer 5

FTC - Federal Trade Commission

Question 6

MSDS Material Safety Data Sheets
i) located in every business and lists various steps and procedures to be followed if an
accident occurs

Answer 6

OSHA

Question 7

The use of gloves or finger cots by clinicians when cuts, scratches or dermatologic
lesions are present on the hands or fingers
c) instruments that come in direct contact with the patient such as occludes, head rests, chin
rests etc. should be wiped clean with alcohol and allow to dry
d) Contact lenses and carrying cases used in trial fittings and follow-up fittings should be
disinfected
e) Hydrogen Peroxide disinfection is the recommendation

Answer 7

HIV and Contact Lenses

Question 8

The FDA oversees what area

Answer 8

medical devices and drug regulation

Question 9

According to the FTC, you must keep digital records for at least

Answer 9

3 years

Question 10

How many hours does a prescriber have to verify a contact lens prescription to an outside seller?

Answer 10

8 hours

Question 11

What entity protects consumers from deceptive and unfair business practices?

Answer 11

FTC

Question 12

Who develops ANSI Z80 standards for ophthalmic lenses, equipment, instruments, and processes in final
fabrication?

Answer 12

VC

Question 13

The CDC offers the public information on which of the following? Check all that apply.
 A. Complications related to contact lens wear
 B. Germs & Infections
 C. Children and contact lenses
 D. Standards in manufacturing contact lenses

Answer 13

All but D