2019 March Bulletin: ADA Act
March 2019 Risk Management Bulletin
Americans with Disabilities Act – Patient Rights and Your Duties
On July 26, 1990, Congress passed the Americans with Disabilities Act of 1990 (ADA) to combat discrimination against individuals with disabilities in employment, public accommodations, state and local governmental services, public transportation, and telecommunications. Included within the definition of “public accommodation” are the professional offices of health care providers, regardless of the size of the office or the number of employees. The Act therefore applies to physicians, dentists, psychologists, hospitals, surgery centers, nursing homes, and all other providers of mental and physical care. All are prohibited from discriminating against disabled people with regard to the provision of goods, services, facilities, privileges, advantages, or accommodations.
Generally, the ADA affects physician practices in three ways:
- Discriminatory employment/hiring practices are prohibited.
- Architectural barriers must be removed.
- Health care providers have a duty to effectively communicate with patients who have vision or hearing impairments.
Enforcement of the ADA and its regulations may be brought about in two ways: private party lawsuits seeking court orders to stop discrimination (no monetary damages are available) and individual complaints to the Attorney General, who is authorized to bring lawsuits with civil penalties that may not exceed $50,000 for a first violation or $100,000 for any subsequent violation.
Formulating a plan now on how to comply with these regulations will promote patient safety and reduce your liability exposure.
RESOURCES
2018 September Alert: CyPass Advice
September 16, 2018 Alert
Clinical Advice on CyPass Issued
Dear OMIC Policyholder,
We are contacting you with an update to our email of September 21, 2018. Please check https://www.omic.com/alcon-voluntary-withdrawal-of-cypass-glaucoma-device/ for future updates, as well as links to the materials discussed below.
Risk management recommendations
OMIC recommends that you take the following steps to promote patient safety and reduce your liability exposure:
- Notify patients with CyPass of the market withdrawal in a letter sent via regular mail. Our sample letter to patients is available at https://www.omic.com/alcon-voluntary-withdrawal-of-cypass-glaucoma-device/.
- Place a copy of the letter in the patient’s medical record, and send a copy to the referring ophthalmologist or optometrist.
- When you do examine the patient, determine if there are any signs of unexpected endothelial cell loss or other problems.
- Share your findings with the patient, and explain your plan for monitoring the eye.
- Document the findings and discussion.
Clinical guidance and additional information are available from both Alcon and ASCRS.
- The Alcon guidance mentioned in the FDA announcement is available at https://www.alcon.com/sites/www.alcon.com/files/CyPass_US_Customer_Letter-8-29_Final.pdf.
- Results of the Compass XT clinical trial were presented at ESCRS. The presentation can be accessed through the Alcon website at https://www.alcon.com/content/cypass-micro-stent-market-withdrawal.
- ASCRS released clinical guidance on CyPass. It is available at http://ascrs.org/sites/default/files/Preliminary_ASCRS%20_yPass_Withdrawal_Consensus_Statement.pdf.
OMIC policyholders may obtain confidential advice by contacting our Risk Management Hotline at 800-562-6642, option 4, or riskmanagement@omic.com.
2019 March Alert: RainDrop Near Vision
March 2019 Risk Management ALERT
FDA Recalls RAINDROP Near Vision Inlay
The FDA issued a Safety Alert about the Raindrop Near Vision Inlay on October 23, 2018. On March 5, 2019, the FDA recalled the device and updated the Safety Alert (https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm623973.htm), which states:
“People who undergo implantation of the Raindrop Near Vision Inlay device are at risk for the development of corneal haze that can affect clear vision. Haze can cause blurry vision or glare by clouding the cornea, or by changing the focusing power of the eye. The impact of haze on the patient’s vision is dependent on the severity of haze and its location in the cornea.”
The FDA made the following recommendations:
- Do not implant Raindrop inlays.
- Contact Optics Medical (Phone: 949-330-6511) for instructions on returning any unused product to the firm.
- Be aware of the new data from the ongoing post-approval study, which is showing 1) high rates of corneal haze in both implanted and explanted patients, 2) an increasing rate of device removal, and 3) that some cases of haze did not develop until 60 months post-implant.
- Monitor patients with the implant, and those whose device has been explanted, for the development of corneal haze.
Risk management recommendations
OMIC recommends that you take the following steps to promote patient safety and reduce your liability exposure:
- PATIENTS ALREADY NOTIFED OF THE SAFETY ALERT AND EVALUATED
- Update patients when they present for their next appointment.
- Share your current findings, and explain your plan for monitoring the eye.
- Educate them about symptoms that should be reported to you.
- Document the discussion.
- PATIENTS WHO WERE NOT NOTIFIED OR EVALUATED
- Notify patients via a letter sent regular mail, and ask them to call your office to make an appointment (available at https://www.omic.com/fda-recalls-raindrop-near-vision-inlay/).
- Place a copy of the letter in the patient’s medical record, and send a copy to the referring ophthalmologist or optometrist.
- When you do examine the patient, determine if there are any signs of corneal haze or other problems.
- Share your findings with the patient, and explain your plan for monitoring the eye.
- Educate them about symptoms that should be reported to you.
- Document the findings and discussion.
2018 November Bulletin: Giant Cell Arteritis (based on 2015 GCA Claims Study)
November 2018 Risk Management Bulletin
Giant Cell Arteritis (GCA)
The short window for diagnosis and treatment and the risk of severe bilateral vision loss underscore the high stakes of this relatively rare condition.
Lawsuits for delay in diagnosis of GCA involve ophthalmologists who had treated patients with it, knew its signs and symptoms well, and understood that emergent treatment is needed to prevent imminent, bilateral vision loss. What, then, led these ophthalmologists astray?
Our resources explore the reasons for these poor outcomes, the standard to which medical experts hold physicians who treat these patients, and the measures ophthalmologists can take to improve the likelihood of a correct and timely diagnosis.
RESOURCES
Giant cell arteritis claims are costly and difficult to defend
2019 February Bulletin: Retina Ischemia
February 2019 Risk Management Bulletin
Management of Acute Retinal Ischemia
We would like to draw your attention to new guidelines on the management of acute retinal ischemia that indicate an urgent need to change how ophthalmologists approach patients with this condition. We also discuss what to do if your community does not have the recommended resources.
According to the guidelines published recently in Ophthalmology, “acute retinal arterial ischemia, including vascular transient monocular vision loss (TMVL) and branch (BRAO) and central retinal arterial occlusions (CRAO), are ocular and systemic emergencies requiring immediate diagnosis and treatment. Because the risk of stroke is maximum within the first few days after the onset of visual loss, prompt diagnosis and triage are mandatory. Eye care professionals must make a rapid and accurate diagnosis and recognize the need for timely expert intervention by immediately referring patients with acute retinal arterial ischemia to specialized stroke centers without attempting to perform any further testing themselves.”
If Your Community Does Not Have a Certified Stroke Center
The new guidelines suggest as an alternative immediately referring patients with TMVL, BRAO, or CRAO to observation units in Emergency Departments, or admitting them to hospitals.
- Determine what resources the nearest Emergency Department and hospitals have for evaluating patients with possible strokes.
- Explore the most efficient process for such patients. While a particular hospital might be closer, the patient may be better served by seeking care at a more distant facility with a predefined accelerated diagnostic protocol for such patients.
Formulating a plan now on how to implement these guidelines will promote patient safety and reduce your liability exposure.
RESOURCES
- Biousse V, Nahab F, and Newman NJ. Management of acute retinal ischemia. Ophthalmology 2018; 125:1597-1607. https://www.aaojournal.org/article/S0161-6420(18)30334-8/fulltext
- Olsen TW et al. Retinal and Ophthalmic Artery Occlusions Preferred Practice Pattern. Ophthalmology 2017; 124: 120-143. https://www.aaojournal.org/article/S0161-6420(16)31378-1/fulltext.
