ABO NOCE Basic Opticianry Laws, Regulations, and Standards Questions and Answers 2 — Questions and Answers

Question 1: Under the FDA's impact resistance regulation 21 CFR 801.410, which lenses are exempt from the impact resistance requirement?

Lenses that cannot be made impact resistant (e.g., certain specialty lenses) with a clearly stated exemption on the prescription (Correct answer)
All glass lenses
Lenses for patients over age 65
Lenses with powers greater than ±10.00 D

Correct answer: Lenses that cannot be made impact resistant (e.g., certain specialty lenses) with a clearly stated exemption on the prescription

21 CFR 801.410 requires impact-resistant lenses for dress eyewear. Exemptions exist for lenses that cannot meet the standard but must have a signed exemption statement from the prescriber.

FDA regulation 21 CFR 801.410 requires that all prescription spectacle lenses dispensed in the U.S. be impact resistant unless an exemption applies. The exemption applies when the prescribing physician or optometrist has determined that impact-resistant lenses will not serve the visual needs of the patient. In such cases, the exemption must be documented with a signed statement from the prescriber. The lens must still meet the drop-ball test (a 5/8-inch steel ball dropped 50 inches onto the lens). Polycarbonate and Trivex always pass; properly tempered glass and hardened plastic may qualify. This regulation is a mandatory topic on the ABO exam.

Question 2: The 'one-year rule' in the Eyeglass Rule (16 CFR Part 456) states that:

Patients must receive a copy of their eyeglass prescription at the end of the examination, which is valid for a minimum of one year (Correct answer)
Opticians must retain patient records for at least one year
Patients have one year to return glasses for a remake
Prescriptions must be renewed annually

Correct answer: Patients must receive a copy of their eyeglass prescription at the end of the examination, which is valid for a minimum of one year

The FTC Eyeglass Rule (16 CFR 456) requires prescribers to give patients their prescription immediately after the exam, enabling them to shop for eyewear. The prescription validity period varies by state law.

The FTC Eyeglass Rule (16 CFR Part 456), enacted in 1978, requires eye care practitioners to automatically provide patients with a copy of their eyeglass prescription at the end of the fitting or examination, without being asked and at no additional charge. This rule was designed to promote competition in the eyewear market by allowing patients to purchase glasses from any retailer. The rule prohibits conditioning the release of a prescription on the patient purchasing eyewear from the prescriber. Prescription validity periods (e.g., 1 or 2 years) are regulated at the state level, not federally. Violations of the Eyeglass Rule can result in FTC action.

Question 3: ANSI Z87.1 is the standard for:

Occupational and educational personal eye and face protection devices (Correct answer)
Prescription ophthalmic lenses for dress eyewear
Contact lens care products
Sunglasses and fashion eyewear

Correct answer: Occupational and educational personal eye and face protection devices

ANSI Z87.1 (American National Standard Practice for Occupational and Educational Eye and Face Protection) sets requirements for safety eyewear including impact resistance, lens marking, and frame requirements.

ANSI Z87.1 is the standard developed by the American National Standards Institute for occupational and educational eye and face protection. It is updated periodically (current version: ANSI/ISEA Z87.1-2020). The standard specifies: (1) impact resistance tests (basic impact and high impact), (2) lens marking requirements (Z87+ for high impact), (3) coverage for safety frames and face shields, (4) optical requirements, and (5) requirements for special-purpose lenses (welding, lasers, UV). OSHA references Z87.1 in its eye protection regulations. Opticians dispensing safety eyewear must ensure lenses and frames meet Z87.1 requirements. This differs from the prescription lens standard ANSI Z80.1.

Question 4: Which U.S. federal law protects patient health information, including prescriptions and vision records, held by eye care providers?

HIPAA (Health Insurance Portability and Accountability Act) (Correct answer)
ADA (Americans with Disabilities Act)
OSHA regulations
The Eyeglass Rule (FTC 16 CFR 456)

Correct answer: HIPAA (Health Insurance Portability and Accountability Act)

HIPAA's Privacy Rule protects individually identifiable health information. Eye care providers are covered entities that must protect patient records and prescriptions.

The Health Insurance Portability and Accountability Act (HIPAA) of 1996, specifically the Privacy Rule and Security Rule, protects individually identifiable health information (PHI). Eye care practices — including optical shops that receive prescriptions — are covered entities under HIPAA if they transmit health information electronically. HIPAA requires: (1) written Notice of Privacy Practices, (2) patient authorization for uses beyond treatment/payment/operations, (3) minimum necessary disclosure, (4) patient rights to access their records, and (5) security safeguards for electronic PHI. Opticians must understand HIPAA to protect patient prescriptions, purchase records, and health information from unauthorized disclosure.

Question 5: The Contact Lens Rule (16 CFR Part 315) requires that:

Prescribers must release contact lens prescriptions to patients, and sellers must verify or get prescriptions before selling contacts (Correct answer)
Contact lens prescriptions are valid for a maximum of 6 months
Patients must purchase contact lenses from their prescribing doctor
Contact lens sellers must obtain a new prescription for each purchase

Correct answer: Prescribers must release contact lens prescriptions to patients, and sellers must verify or get prescriptions before selling contacts

The FTC Contact Lens Rule requires automatic release of contact lens prescriptions and mandates that sellers verify prescriptions with prescribers before dispensing contacts.

The FTC Contact Lens Rule (16 CFR Part 315), enacted under the Fairness to Contact Lens Consumers Act (FCLCA), requires: (1) Prescribers must provide patients with a copy of their contact lens prescription at the end of the fitting, at no extra charge, even if not asked. (2) Sellers (online, optical shops) must obtain a copy of the prescription or verify it with the prescriber before dispensing. (3) Prescribers must respond to verification requests within 8 business hours. (4) Sellers may not substitute a different contact lens brand without prescriber authorization. This rule ensures competition in the contact lens market and patient access. Updated rules (2020) added requirements for direct communication verification.

Question 6: According to ANSI Z80.1, what is the allowable tolerance for cylinder axis in a prescription of -2.00 × 180?

±7° (Correct answer)
±3°
±5°
±10°

Correct answer: ±7°

Per ANSI Z80.1, for a cylinder power of -2.00 D, the axis tolerance is ±7°. Axis tolerance is ±14° for 0.125–0.375 D cyl, ±10° for 0.375–0.75 D, ±7° for 0.875–1.50 D, and ±5° for >1.50 D.

ANSI Z80.1 specifies axis tolerances that become tighter as cylinder power increases (because axis errors cause more power error with higher cylinders). The tolerance schedule is: 0.12–0.37 D cylinder: ±14°; 0.37–0.75 D: ±10°; 0.75–1.50 D: ±7°; >1.50 D: ±5°. For -2.00 D cylinder, the power is in the 0.75–1.50 D range (absolute value 2.00 D > 1.50 D), so the tolerance is ±5°. Note: some sources quote this differently based on the standard version. The key principle is that axis accuracy becomes more critical as cylinder power increases. Lensometer verification of axis is mandatory before dispensing.

ABO NOCE Basic Opticianry Laws, Regulations, and Standards Questions and Answers 2

Under the FDA's impact resistance regulation 21 CFR 801.410, which lenses are exempt from the impact resistance requirement?