Risk Management Recommendations
Many of the forms linked in the paragraphs below are in Rich-Text Format (RTF). If you are on a PC, your browser will use a word-processing application such as MS Word to open the document within your browser window. If you are on an Apple computer, the file will be downloaded to a designated folder or your desktop.
Advertisements for Medical/Surgical Services
Physician advertising is subject to rules and guidelines produced by the Federal Trade Commission and the Food and Drug Administration, as well as state law. Professional societies, such as the American Academy of Ophthalmology and the American Society of Cataract and Refractive Surgeons, have also published information designed to promote professionalism and ethics. Our "Advertising Medical Services" explains the guidelines and the liability risks while the "Advertising Review Form" can help identify aspects of the advertisement that may be misleading or deceitful.
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Amblyopia Risk Reduction: Recommendations, Treatment Agreement, and Referral Report
Medical malpractice lawsuits for negligent treatment of amblyopia are infrequent, but the risk to the pediatric patient’s vision is extreme. If not treated appropriately by age nine, the child can have permanent vision loss. The main risk issue is noncompliance with patching and follow-up appointments. Click here for recommendations, a treatment agreement, and a referral report.
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Anesthesia Liability
Ocular anesthesia is challenging for both the ophthalmologist and the anesthesiologist. Special concerns include patient anxiety about decreased vision, eye surgery, and pain or movement during eye surgery; multiple medical co-morbidities, especially in elderly patients; pediatric patients, some premature with congenital syndromes; limited access to the patient and need for immobility during surgery; problems with intraocular pressure and anesthetic agents; and oculocardiac reflexes. Click here for risk management recommendations to promote patient safety and reduce your professional liability exposure.
Ophthalmologists who would like more information about administering sub-Tenon's anesthesia can view this demonstration video produced by Dr. James Salz and Dr. Samuel Masket.
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Avastin Use Recommendations and Consent Form
Avastin™ (bevacizumab) is administered off-label for the treatment of a number of ophthalmic conditions. This document answers many questions ophthalmologists have about the patient safety and professional liability risks of this medication. Click here for a patient consent form.
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Botox Cosmetic Issues and Injectable Safety Issues
Cosmetic Botox injections are frequently administered in ophthalmology practices. The risk management recommendations in this document are designed to promote patient safety and reduce the physician's liability exposure.
To learn more about injectable cosmetic treatments, appropriate injectors and where to safely access cosmetic medical procedures please link here http://www.injectablesafety.org/html/about.php
to the Injectablesafety.org. To learn more about the Kansas State Board of Healing Arts ruling on Lipodissolve, please download this document.
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Cataract Surgery Interval Recommendations
Ophthalmologists are at times asked by patients who live far from the hospital or surgery center, or those with significant medical co-morbidities, to perform cataract surgery on the same or consecutive days. This risk management recommendation letter will provide information for the physician to consider during the decision-making process.
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Cataract Surgery: recommendations, patient consent form, and patient information sheet
Cataract surgery is the most frequently performed ophthalmic procedure in the United States, and thus the source of the majority of the medical malpractice claims reported to OMIC. When the outcome does not match these heightened expectations, patients are more apt to complain not only to their ophthalmologist, but to acquaintances, insurance companies, regulatory agencies, malpractice attorneys, and, in increasing numbers, even to the Ethics Committee of the American Academy of Ophthalmology (AAO). Click here for current OMIC risk recommendations regarding cataract surgery. Click here for a patient cataract surgery consent form. Click here for a patient information sheet on cataract surgery.
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Comanaging Patients With Other Ophthalmologists and Optometrists
Many ophthalmologists have questions about comanaging patients with other ophthalmologists and optometrists. "Comanaging Ophthalmic Patients" provides an overview of patient safety and liability risks, reasons for comanagement, legal issues, credentialing, protocols, preoperative evaluation, and postoperative care. Click here for a sample consent form.
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Confidentiality/Privacy Issues and Malpractice Claims
Physicians often have questions about sharing protected health information (PHI) with their professional liability carrier or an attorney during the investigation and litigation of a medical malpractice incident, claim, or lawsuit. "Confidentiality/Privacy Issues and Malpractice Claims" provides general information in dealing with six common scenarios.
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Dilating Drops: Patient Safety and Liability Risks
Dilating drops are used on countless patients daily during diagnostic examinations and surgical procedures. They are essential in order to obtain an adequate view of the retina and fundus. Indeed, failure to perform a thorough examination of the eye could lead to significant patient harm such as delay in diagnosis or failure to diagnose, as well as surgical complications due to poor visibility. This document will address the patient safety risks and malpractice allegations, and provide risk management recommendations.
See also: Discuss Potential Side Effects of Eye Drops, Information Regarding Dilating Drops (for the patient), Making Your Office Safe, and Closed Claims Studies - Patient Slip and Fall Following Dilation.
Driving Issues: Vision Requirements for Driving
Several resources are available to assist ophthalmologists in determining whether patients are able to drive, and what to do when they are not. Click here for a link to "Vision Requirements for Driving," which discusses the components of an examination of a patient's driving ability. Click here to access the American Medical Association's "Physician's Guide to Assessing and Counseling Older Drivers." For a discussion of the duty to warn patients and confidentiality issues, click here to see OMIC Vice President Paul Weber, JD's article, "When Patients Shouldn't Drive".
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Discontinuing Treatment for Financial Reasons
Costly diagnostic equipment and rapidly evolving treatment options that rely heavily upon technology contribute to making ophthalmology an expensive medical specialty. While some businesses can pass such costs onto the consumer, ophthalmology practices are limited by what health plans and the government are willing to pay. Decreases in reimbursement from these payers may prompt some physicians to reevaluate their bottom line and consider discontinuing treatment. Before taking such a step, ophthalmologists would be well-advised to consider the patient safety and professional liability risks. Click here for more information.
Employees: Providing Medical Care, Services, or Products
Physicians may treat their employees. There are patient safety and professional liability risks, however, if the physician does not provide medical care and services to employee patients in the same manner as any other patient. This risk management recommendation letter will examine those risks and provide recommendations on how to minimize them.
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EMTALA (Emergency Medical Treatment and Active Labor Act)
This federal law governs how patients are treated in emergency rooms, and imposes duties on ophthalmologists who serve on-call to hospitals. EMTALA: An Overview for Ophthalmologists provides information on the basic obligations hospitals and physicians have under EMTALA. The Ophthalmologist's Role in Emergency Care focuses on on-call and follow-up duties.
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Endophthalmitis/TASS Recommendations and AAO/ASCRS Reports
While not all adverse events can be prevented, there is much ophthalmologists can do to reduce the incidence of endophthalmitis and TASS. In its review of OMIC's claims experience and the lessons learned from it, this article offers risk management guidance on more effective prevention, recognition, and response to these sight-threatening conditions. The AAO and ASCRS have asked ophthalmologists to track and report TASS cases. This document contains the reporting forms. An effective response depends upon careful coordination and cooperation among the facility, surgeon, and patient. The facility needs to sequester all involved materials, interview staff, and evaluate equipment, devices, solutions, medications, and the sterilization process. All aspects of the investigation should be carefully documented. The investigation will help locate the responsible organism or toxic agent, ascertain liability, and determine what steps to take to remedy any identified problems. Dr. Mamalis's group developed an Excel-based protocol that can be used for individual or clustered cases of infectious or sterile endophthalmitis, which is available here.
eRisk Guidelines
The eRisk Guidelines have been developed by the eRisk Working Group for Healthcare, a consortium of professional liability carriers, medical societies and state licensure board representatives. OMIC is part of this group, and helped develop and revise these guidelines for email and other internet-based physician services.
Fluorescein Angiography: Preventing and Responding to Complications
Fluorescein angiography is an invasive procedure with associated risks and notably, but rarely, of a life-threatening allergic reaction. These risk management recommendations have been compiled to assist you and your staff so that you may both 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. Click here for the Fluorescein Angiography Consent Form.
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Giant Cell Temporal Arteritis
Allegations of failure to diagnose are common in medical malpractice lawsuits against ophthalmologists. This document focuses on giant cell (temporal) arteritis. The risk management recommendations can help promote patient safety and reduce liability exposure.
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Hemorrhage Associated With Ophthalmic Procedures
Ophthalmologists routinely warn patients that ophthalmic surgery could result in infection, vision loss, and hemorrhage. OMIC claims data indicates that ophthalmologists who do not properly screen patients for bleeding risks and manage hemorrhage when it occurs often face malpractice lawsuits. An OMIC closed case study of hemorrhage following blepharoplasty that resulted in a large settlement is presented to highlight errors in management that led to blindness and a subsequent lawsuit. Many other aspects of the prevention and management of hemorrhage deserve attention. The few discussed here have figured most prominently in malpractice cases.
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HIPAA Authorization
OMIC has revised the authorization to make it easier for patients to understand.
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History and Physical Examinations
Many patients contemplating eye surgery also have medical conditions that could increase the risk of the operative or diagnostic procedure and anesthesia/sedation. In 2002, CMS began mandating a reassessment within 7 days prior to surgery, and JCAHO recently instructed facilities that the patient's condition must be updated within 24 hours of the procedure. As a result, ophthalmologists are being asked to either conduct the reassessment themselves or cosign one done by a Certified Registered Nurse Anesthetist (CRNA), Physician's Assistant (PA), or Nurse Practitioner (NP). Click here for OMIC's risk management recommendations.
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Informed Consent: Obtaining and Verifying
To honor the patient's right to make decisions about health care, ensure patient understanding, and prevent allegations of lack of informed consent, follow these risk management guidelines. Click here for recommendations on obtaining and verifying informed consent.
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INTACS: Off-Label Therapeutic Use for Post-LASIK Ectasia
Intacs® are intrastromal corneal ring segments available through Addition Technology, Inc., and FDA-approved for the treatment of myopia. Although initially approved for elective refractive surgery, some ophthalmologists use them as a therapeutic treatment for ophthalmic conditions such as keratoconus or post-refractive surgery ectasia. Click here for the risk management recommendation. Click here for the consent form.
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Interpreters for Deaf and Limited English Proficiency (LEP) Patients
Physicians are well aware of the central role clear communication plays in the physician-patient relationship. Patients with limited English proficiency or who are deaf present special challenges to effective interactions. Ophthalmologists often have questions about how to obtain and reimburse interpreters, and whether family members can fulfill this role. These documents will provide some basic information on the federal rules concerning these topics and present risk management recommendations on how to best meet the needs of these patients and the practice. Click here for guidance with deaf patients; click here for suggestions with LEP patients.
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Intraoperative Floppy Iris Syndrome
A syndrome named intraoperative floppy iris syndrome or IFIS has been linkedto a medication called Flomax, which is prescribed for men with prostatic hypertrophyand women with urinary retention. Click here to link to an AAO article by Dr.David F. Chang that gives recommendations on how to prepare for and manage it.
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Kenalog™ Recommendations and Consent
On 22 November 2006, Bristol-Myers Squibb mailed a "Dear Healthcare Provider" letter to ophthalmologists, informing them that the company had added additional information to the prescribing information to recommend against administering Kenalog™ by intraocular, intraturbinal, subconjunctival, sub-Tenons, retrobulbar, nasal turbinate, and intralesional (about the head) routes. Our Risk Management department prepared a document that clarifies OMIC's understanding of "off-label" use of approved medications, and offers risk management recommendations specific to intravitreal administration of Kenalog™ (triamcinolone acetonide). Click here for a sample consent form. The American Academy of Ophthalmology sent a letter to the manufacturer on behalf of its members, and compiled a bibliography of articles about triamcinolone acetonide. Both are available in Members Alert, which can be found under Quality of Care in the Clinical Education section at AAO Members Alert.
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Leaving a Practice or Retiring
Physicians leave practices for many reasons, including illness, retirement, changes in employment status, and personal or family needs. Both the individual ophthalmologist and the practice need to take steps in order to promote continuity of care, prevent allegations of abandonment, and ensure that all involved physicians have access to the medical records in the event the care is ever called into question. Taking these steps will also ensure compliance with provisions of contracts and with requirements of state medical boards. Taking these steps will also ensure compliance with provisions of contracts and with requirements of state medical boards.
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Medical Records Retention
OMIC is pleased to provide guidelines for medical records retention for ophthalmic practices. The guidelines can be accessed by clicking here.
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Noncompliance Guidelines with Sample Missed Appointment Letter
Patients who do not show up for appointments or comply with treatment recommendations represent a significant professional liability risk for ophthalmologists. This document outlines the issues and provide risk management recommendations to promote patient safety and protect physicians and their staff, as well as sample missed appointment and noncompliant letters. These sample missed appointment and noncompliant letters are also available in Spanish.
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Observers Present During Medical Procedures
Ophthalmologists or ophthalmic surgery or laser centers at times require or desire the presence of observers during an ophthalmic procedure. Such observers include sales representatives from medical device or medical equipment manufacturing companies, visiting colleagues, or family members. Patients sometimes want their family members to be with them during a procedure. In order to honor the patient's right to privacy and the physician's and facility's duty to protect the confidentiality of medical information, and to ensure the safety of patients, staff, and visitors, certain policies and procedures need to be in place. This document will provide an overview of the issues associated with observers, and provide a sample consent form.
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Off-label Drugs and Devices
Sample Language For Off-label Consent. Physicians are well-advised to obtain informed consent for off-label devices or drugs. Click here for sample consent language to incorporate into consent forms as needed.
Click here for a list of articles and forms about the use of off-label and unapproved drugs and devices.
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Office Based Surgery for AdultsSome ophthalmic surgical procedures can be safely performed in an office surgical suite. Others with higher risk profiles raise a number of concerns. If a patient experiences a serious complication or poor outcome and decides to sue the ophthalmologist, all aspects of the care will be questioned, including the decision to perform the procedure in the office. This document will provide an overview of the issues associated with office based surgery for adults.
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Research or the Practice of Medicine?
The growing number of medications under use and investigation to treat retinal and other conditions of the eye often lead to questions about how to distinguish between research and medicine. This determination is important, as physicians who conduct research are subject to state and federal law. This document addresses research, "off-label" use, and when an investigational drug exemption is required.
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ROP: Creating A Safety Net
Screening and treating premature infants for retinopathy of prematurity (ROP) is an important aspect of pediatric ophthalmic care that provides a valuable service to not only the individual patient but also to society as a whole. To help promote patient safety and minimize the potential liability exposures associated with these critical activities, OMIC offers these risk management recommendations as well as a sample consent form for laser surgery. Click here to see document.
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ROP: Sample Indemnification Language
Examining premature infants for retinopathy of prematurity (ROP) is an important aspect of ophthalmic care. Click here for examples of sample language. Also see the article "Shared Liability for ROP Screening" in OMIC Digest, Fall 2003 Volume 13 Number 4.
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Telephone Screening of Ophthalmic Problems
Making medical decisions on the basis of the limited information obtained over the telephone is a risky--albeit necessary--aspect of ophthalmic practice. To promote patient safety and reduce your liability exposure, develop and implement a telephone screening protocol. Click here for a risk analysis and OMIC's sample contact forms and screening guideline. Click here for a printable after-hours telephone call form.
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Terminating the Physician-Patient Relationship
Following our termination guidelines can help minimize the risk of patient harm, and reduce the likelihood of allegations of patient abandonment. See Terminating the Physician-Patient Relationship. A sample termination letter is also available in Spanish.
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Terminating the Physician-Patient Relationship for Financial Reasons
It is well established that physicians may discharge a patient for a number of reasons, including non-payment. Click here for a discussion of this issue. Click here for a sample letter.
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Traumatic Eye Injuries
Allegations of failure to diagnose are common in medical malpractice lawsuits against ophthalmologists. This document will focus on traumatic eye injuries, and follow a patient who was referred to an ophthalmologist with a history of being struck in the eye with metal when a screwdriver shattered a screw. There was a delay in diagnosing a metallic foreign body. The resulting endophthalmitis could not be successfully treated, and the patient required an enucleation and prosthesis. The risk management recommendations offered here can help promote patient safety and reduce liability exposure.
Unanticipated Outcomes: Steps for Responding
Dealing with unanticipated outcomes is one of the most difficult aspects of medical practice, especially if an error contributed to the result. While many physicians want to talk to their patients about adverse events, they may hesitate to do so for a variety of reasons. OMIC has always encouraged its policyholders to communicate honestly and compassionately with their patients about unanticipated outcomes. In order to provide more guidance for ophthalmologists on how to handle these difficult situations, OMIC offers these risk management recommendations. Please click here to access these guidelines.
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Unapproved Devices
Ophthalmologists are privy to various treatment alternatives, many of which are tested and employed by their peers around the world long before they are approved for use here in the U.S. Before deciding whether or not to use the newest device available, physicians would be well advised to evaluate the patient safety and professional liability risks. Our checklist, "Risk Analysis of Unapproved Devices," is a useful tool and can be accessed here.
For an overview of the risks of using unapproved devices, refer to When FDA Leaves Doctors To Their Own Devices.
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Verisyse™ Phakic Implant Informed Consent
Click here for recommendations and consent form.
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Visian ICL™ Phakic Implant Surgery
Click here for recommendations and here for consent form.
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Wrong Site Surgery and of Wrong IOL Placement
OMIC would like to call your attention to the important work being done by various organizations to prevent wrong site surgery and wrong IOL placement. In 2001, the American Academy of Ophthalmology, the American Society of Ophthalmic Registered Nurses, and the American Association of Eye and Ear Hospitals produced "Patient Safety Bulletin Number 1: Eliminating Wrong Site Surgery." The bulletin contained "Suggestions for a Checklist to Verify the Operative Eye." It is available on the AAO website here and ASORN websites here. "Patient Safety Bulletin Number 2" addressed the reasons behind wrong IOL placement. It is available at the AAO website, here or at the ASORN website, here. The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) has proposed a Universal Protocol for Eliminating Wrong Site, Wrong Procedure, and Wrong Patient Surgery, which is available here.
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