Contact Lens Legal Issues (F) Flashcards
What are the conditions of the Fairness to Contact Lens Consumers Act (FCLCA)?
- mandatory release of CL Rx at the completion of the CL fit, requested or not
- fitting defined by when a successful fit has been achieved
- written Rx provided at no cost and cannot be contingent on the purchase of lenses
What are the elements of an monovision informed consent?
- evidence of reduced binocularity and depth perception
2. recommend glasses over or take lenses out while driving
What are the elements of an extended wear informed consent?
- increased risks of ocular complications
AND pt must: - Maintain regularly scheduled follow up appts
- Care for lenses appropriately
- Wear and replace lenses appropriately
- Monitor significant ocular symptoms and remove lenses and report for care immediately if occurs
Who is liable for a product liability case?
- CL practitioners
2, dispensers are liable if defective product
What are the most common doctor-patient agreements that are made to be signed?
- CL fitting agreements
- CL service agreements
- informed consent
What are the best practices in order to minimize the risk of malpractice loss?
- communication is key
- clear, accurate, and complete documentation
- provide 24 hour access to emergency services
- refer patients you are unable to fit, need specialty care, or have adv ocular complication
What are the elements of a CRT informed consent?
same as EW but also that it is a temporary reduction in refractive error
What CL wearers need to for sure sign an informed consent?
- extended wear
- corneal refractive therapy (CRT)
- monovision or multifocal lens wear
How long must lens sellers keep records of verification transactions?
3 years
What are the requirements elements on a CL Rx?
- patient name
- date of exam
- issue date and expiration
- name, address, phone number, fax number of prescriber
- lens manufacturer
- lens material
- lens powers
- base curves
- diameters
What are the additional elements that are recommended to be put onto CL Rx’s?
- wear schedule
- replacement schedule
- care instructions
- maximal amount to be dispensed
What is the doctor-patient agreement that is for existing patients that wear CLs that talks about costs for lenses and care? 1. What should you never call this? 2
- contact lens service agreement
2. contact lens insurance plan
What are the most common cases of negligence in CL care?
- Failure to deliver comprehensive eyecare
- Failure to provide adequate follow up CL care
- Ocular health complications resulting from CL wear, especially extended wear
What is the doctor-patient agreement that educates the patient on the basics of CL fitting for a new wearer and the specifics for your office (cost, refund, etc)?
contact lens fitting agreements
What is the doctor-patient agreement that talks about the right of the patient to refuse any procedure and they have the info from the doctor?
informed consent
What are the conditions of expiration dates made by the Fairness to Contact Lens Consumers Act (FCLCA)?
- must be at least 1 year from original issue date
- can be longer if state allows
- can be shorter based on medical judgement
What is the federal legislation on contact lens sales?
Fairness to Contact Lens Consumers Act (FCLCA)
What factors must there be in order to prove negligence?
- A duty exists obligating the doctor to a standard of conduct to protect a patient against unreasonable risk of injury
- A doctor was in breach of that duty
- The doctor’s breach resulted in an injury or loss to the patient
- Damages must be incurred by the patient
What is the proposed CL update to the FCLCA from the FTC?
prescriber must obtain a signed acknowledgment from patients that they were given their CL Rx and keep for 3 years
