The following paper is reprinted from Argus, Nov-Dec., 1995:
Legal Issues Arise When Unlicensed Ophthalmic Personnel Administer IV Fluorescein
By Jean Hausheer Ellis, MD, and Paul Weber, JD
Argus, Nov.-Dec., 1995
Medical malpractice lawsuits arising from administration of intravenous fluorescein angiography -- one of the most commonly performed procedures in the ophthalmic office -- are relatively rare but can be expensive when they occur. In 1993, a $475,000 settlement was made against a non-OMIC ophthalmologist whose patient suffered an anaphylactic reaction and died after injection of sodium fluorescein. Ophthalmologists risk other equally serious legal and insurance coverage problems when unlicensed personnel administer IV sodium fluorescein in the ophthalmologist's office.
Ophthalmic personnel who administer IV fluorescein must be properly licensed by their state to do so. Unlicensed personnel expose themselves and their employer-ophthalmologist to civil liability, i.e., medical malpractice claims. Under the legal doctrine of respondeat superior, an employer is generally liable for the negligent acts of the employee when carried out within the scope of employment.
An ophthalmologist who aids and abets the performance of a medical or surgical act by an unlicensed person (even if it is medically appropriate and under the ophthalmologist's direct supervision) may be violating state laws, which carry criminal penalties and affect the physician's licensure. State laws vary concerning who is properly licensed to administer IV fluorescein. According to a survey reported in The Journal of Ophthalmic Photography (November 1989), registered nurses are licensed to administer fluids or drugs via IV therapy in all 47 surveyed states. Eighteen states also allow physician assistants and specially trained licensed vocational nurses to perform IV injections. However, only four states permit medical assistants to perform these injections and only two allow ophthalmic photographers to do so. In some states, such as California, the medical assistant may place the needle to start an IV but may not administer injections.
Given these variances, ophthalmologists should consult their state department of professional regulation or equivalent agency to determine which staff can legally administer IV fluorescein.
Proper licensing becomes an extremely important issue in medical malpractice lawsuits. If ophthalmic personnel violate a statute (e.g., practicing nursing without a license) by administering IV fluorescein without the proper license, this paves the way for a plaintiff to prove negligence because he or she will allege that the act (IV administration of fluorescein) was negligence per se. In most states, under the doctrine of negligence per se, if a plaintiff demonstrates that the injury resulted from an act which violated a statute intended to prevent the injury, the only issue remaining for a determination of negligence is the commission of the prohibited act. Once this is proven, the plaintiff's lawyer merely must establish the amount of monetary damages the plaintiff incurred.
Many professional liability insurance policies cover claims arising from professional services performed by the physician's non-physician employees within the authorized scope of their employment, licensure and training. However, if a lawsuit is brought by a patient injured during the course of treatment rendered by an employee outside the scope of the employee's license (e.g., injection of IV fluorescein), a coverage dispute with the insurance carrier could arise.
Therefore, allowing non-licensed personnel to administer IV fluorescein not only makes it easier for the plaintiff to prove negligence, but it can potentially put the ophthalmologist in the precarious situation of jeopardizing his or her professional liability insurance coverage. Other important medicolegal issues surrounding fluorescein angiography include informed consent and emergency response capabilities. OMIC has addressed these issues in previous risk management articles. To receive a copy, along with a sample informed consent for angiography and a wall chart listing reactions and treatment to IV fluorescein, fax your request to OMIC's risk manager, 415-771-7087.