Fluorescein Angiography:  
Preventing and Responding to Complications

Anne M. Menke, RN, PhD
OMIC Patient Safety Manager

PURPOSE OF RISK MANAGEMENT RECOMMENDATIONS 
OMIC regularly analyzes its claims experience to determine loss prevention measures that our insured ophthalmologists can take to reduce the likelihood of professional liability lawsuits. OMIC policyholders are not required to implement these risk management recommendations. Use your professional judgment in determining the applicability of a given recommendation to your particular patients and practice situation. These loss prevention documents may refer to clinical care guidelines such as the American Academy of Ophthalmology’s Preferred Practice Patterns, peer-reviewed articles, or to federal or state laws and regulations. However, our risk management recommendations do not constitute the standard of care nor do they provide legal advice. Consult an attorney for legal  advice. Information contained here is not intended to be a modification of the terms and conditions of the OMIC professional and limited office premises liability insurance policy. Please refer to the OMIC policy for these terms and conditions.
Version 7/13/17

Fluorescein angiography (FA) is a diagnostic procedure. A photographer takes a rapid sequence of photographs of the blood vessels in the retina and choroid (the back of the eye). The dye is usually injected into a vein in the arm, forearm, or hand. While generally well tolerated, angiography is an invasive procedure with risks. The most severe risk, while rare, is of a life-threatening allergic reaction. Here are some risk management recommendations to help you and your staff members prevent and better respond to the risks of the procedure. Issues addressed here include delegation of tasks, informed consent, emergency response equipment, and management of complications.

DELEGATING TASKS TO UNLICENSED STAFF
The laws as to who may perform venipuncture and administer the intravenous (IV) fluorescein dye vary by state. Unlicensed personnel may perform venipuncture. In some states, however, they must first complete specific training and certification. Medications or dyes administered intravenously are rapidly absorbed, and thus place the patient at significant risk. Accordingly, many states allow only licensed personnel, such as registered nurses, to administer fluorescein. Other states give physicians broader delegating authority. 

Determine the laws governing venipuncture and the administration of IV fluorescein by contacting your state’s medical society, medical board, and nursing board. If the law does not specify who may perform these tasks, seek the advice of your practice attorney. Make patient safety a priority. Train and certify staff members, and include these tasks in their job description. 

INFORMED CONSENT
Many ophthalmic practices provide FA in their own office. The ophthalmologist ordering the procedure discusses its risks, benefits, and alternatives with the patient. As with all informed consent discussions, arrange time for the patient’s questions and concerns. Document the informed consent discussion in the patient’s record, making sure to note any of the patient’s particular questions or concerns. Ask the patient to sign an informed consent document (see the sample consent form at the end of this document). While only the surgeon may obtain informed consent, any delegated staff member may obtain the patient’s signature on the form after the consent discussion and before the FA. Patients who need repeat FAs may consent to a series of these procedures. Consent for a series of treatments is valid until 1) the patient revokes consent or 2) the patient’s condition changes to the point that the risks and benefits are significantly different. 

SCREENING, RESPONSE, EQUIPMENT, AND STAFF TRAINING
Facilities located within a hospital have the benefit of a code blue team. However, all facilities need to have an emergency response plan. Here are some elements for you to include in the written protocol for your facility.  

To promote patient safety, staff members who perform the procedure can screen patients for possible contraindications by asking about the following items before each FA: pregnancy, food and drug allergies, prior reactions to the dye, and a history of asthma. Bring these patients to the attention of the ophthalmologist for clearance prior to injecting. Determine if patients with allergies need pre-treatment to reduce the likelihood of a reaction, or should have the procedure done in the hospital. Document discussions with the patient. Put your protocol in writing and train staff in its use. 

Staff must both anticipate and be prepared to respond to the “worst case scenario,” which in this procedure is a severe allergic reaction. An ophthalmologist must be on site during FAs. Inform the ophthalmologist when an injection is about to take place so that he or she can immediately respond to any complications that arise. Two staff members need to stay with the patient (either in the room with the patient or within shouting distance) during the FA procedure. This way, in case of an emergency, one staff member can stay with the patient while the other can call 911 if ordered to do so by the physician. 

OMIC recognizes that the standard of care for emergency equipment is evolving and has no position on the need for an AED in physician offices. An AED may afford an added margin of safety during invasive procedures, especially for patients with cardiovascular problems. Train ophthalmologists and staff in proper use of an AED if you have one. There is arguably more liability if you have an AED and don’t know how to use it than if your facility has no AED. The American Heart Association provides training on AEDs in Basic Life Support for Healthcare Provider courses.

Prepare an emergency kit with basic emergency medical equipment, and check it regularly. Review the FA product insert for guidance on needed medications. Place a label on the outside of the kit listing the drugs, expiration date, dose, etc. The American Society of Ophthalmic Registered Nurses (ASORN) has an excellent office procedure manual, which includes a written protocol and equipment list for FA; this can be helpful in preparing the emergency kit.  You may purchase Ophthalmic Procedures in the Office and Clinic through the AAO website at https://store.aao.org/ophthalmic-procedures-in-the-office-and-clinic-3rd-edition.html. Schedule a few meetings with a “committee” of technicians, administrators, and physicians to discuss an emergency course of action. Document the decisions and formulate a written policy on the emergency kit and procedures. 

REACTIONS TO FLUORESCEIN
Patients have experienced a number of reactions to the fluorescein dye and injection process. These include nausea, vomiting, discomfort from local extravasation (leaking of the dye), fatigue, fainting, and skin problems such as urticaria and pruritis (itching). In the event of a reaction, it is important to document the patient’s signs and symptoms, actions taken in response, and discharge condition and instructions. The FA procedure in the ASORN manual contains useful recommendations on preventing and treating these adverse events.

OMIC’s Risk Management Department can be an important source of information and support for policyholders engaged in these evaluations and discussions.  Please call 1.800.562.6642, option 4 or email us at riskmanagement@omic.com.  We are also happy to answer questions about our protocols from non-policyholders.

PLACE LETTERHEAD HERE AND REMOVE NOTE.   
CHANGE FONT FOR LARGE PRINT

NOTE:  THIS IS A SAMPLE FORM. IT CONTAINS THE INFORMATION YOU AS THE SURGEON SHOULD PERSONALLY DISCUSS WITH THE PATIENT.  PLEASE REVIEW IT AND MODIFY TO FIT YOUR ACTUAL PRACTICE.  GIVE THE PATIENT A COPY.

Version 7/13/17

INFORMED CONSENT FOR FLUORESCEIN ANGIOGRAPHY

Patient:										

Fluorescein angiography or FA shows how the blood flows inside your eye. It helps your ophthalmologist (eye physician) know what is causing your eye problems. First a dye is injected into a vein in your arm or hand. Then a photographer takes photos. You may need to get FAs again to see if the treatment is working or if your eye problem is worse.

Risks (problems FA can cause)
You may have some minor problems after the injection. Here are some: fatigue, nausea, vomiting, headache, upset stomach, light-headedness, fainting, hives, and itching. 

A few patients have had severe allergic reactions (anaphylaxis) or bronchospasm (which causes breathing difficulties) after FA. These conditions can be life threatening. Be sure to tell your ophthalmologist about allergies to food, dyes, or medications, and reactions to dyes. Tell your ophthalmologist if you have asthma.

Sometimes, the dye leaks out of the vein. This leakage is painful. 

The fluorescein dye is bright yellow, so your skin may appear jaundiced (yellowish) for a few hours. The dye leaves the body through the kidneys, so your urine will be bright yellow for 24 to 36 hours.

The ophthalmologist may ask you for permission to use the FA photos of your eyes for educational or scientific purposes. The photos show only the blood vessels inside your eyes. No one can tell who you are from the photos.

By signing below, you consent (agree) that:
•	You read this informed consent form or someone read it to you.
•	The ophthalmologist explained why you need an FA and the problems it can cause. 
•	The ophthalmologist or staff member answered your questions about FA. 
•	You have told your ophthalmologist about any of these problems: allergies to food, iodine, or medications; reactions to dyes used in the eye; asthma; if you are pregnant or nursing a baby.
•	You consent to keep having another FA if needed. You consent to FA until 1) you tell your ophthalmologist you do not want another FA or 2) your eye or health problems change so much that there are new risks and benefits to discuss with the ophthalmologist.
•	The ophthalmologist may use the FA photos of the inside of your eyes for educational or scientific purposes.

____________________________ 	___________________
Patient’s Signature				Date