Clarification of Roles During the Informed Consent Process
Anne M. Menke, RN, PhD, OMIC Risk Manager
Digest, Fall 2005
Recently, OMIC revised its sample consent form for cataract surgery, partly in response to the new “multifocal IOLs” and partly to better prepare patients for the procedure and defend ophthalmologists against allegations of lack of informed consent. Soon after the form revision was announced in our E-Bulletin and the AAO Express, policyholders began calling with questions about the roles they, their office staff, and the ASC play in the informed consent process.
Q I just reviewed OMIC’s new cataract consent form. Do you really expect me to review all six pages with each of my patients?
A The short answer is no. A more complete response should help clarify the phases of the informed consent process and the roles played by various members of the health care team. As the surgeon, you have a legal duty to obtain the patient’s informed consent, which is best understood as an oral agreement you reach with the patient after the informed consent discussion. This face-to-face talk addresses the ophthalmic condition and the risks, benefits, and alternatives—including no treatment—of the proposed procedure. The discussion must always take place before the patient signs any consent form, while the patient is awake and aware, and free from the effects of any medication that could interfere with his or her ability to participate in the decision-making process. The form itself serves to document and verify that the informed consent discussion with you took place. Neither the form nor any video or teaching aids can substitute for the face-to-face talk with the surgeon.
Q Do I have to mention all known risks during my discussion?
A No. The standard discussion most ophthalmologists conduct is rarely as detailed as a procedure-specific consent document and usually consists of a summary of this information. You do, however, need to address any particular concerns of the patient as well as any condition that puts the patient at increased risk, and then write a brief note in the medical record. To help educate the patient and provide more details about the surgery, OMIC recommends that you give patients a copy of the procedure-specific consent form. Some practices ask the patient to read it before the preoperative meeting with the surgeon; others have a staff member go over it with the patient afterwards.
Q Can my staff members witness the patient’s signature even if they were not present during the discussion?
A Yes, since what is being witnessed is the patient’s signature. While they cannot obtain the patient’s informed consent, staff members play an invaluable role in patient education. As a risk management measure, staff members should ask patients what procedure will be done and why before asking them to sign the form. If the patient does not appear to understand, staff members should inform you so that you can discuss the procedure again and clear up any confusion or misunderstanding. Staff members can then document that you discussed the procedure again with the patient and that the patient appeared to understand and signed the consent.
Q Can I just use the consent form at the hospital or ambulatory surgery center (ASC)?
A No, since that form’s primary purpose is to document that the ASC or hospital has fulfilled its own, separate legal duties. The ASC or hospital cannot obtain the patient’s informed consent for the procedure you are performing; only the ophthalmologist can do that. Hospitals and ASCs must verify, however, that the surgeon obtained informed consent before allowing the procedure or surgery to take place. ASCs and hospitals also have a separate duty to obtain what is known as general consent for the care and treatment provided at their facility by their employees and other providers, e.g., the anesthetist. There is no discussion of specific risks or benefits of the ophthalmic procedure when obtaining this general consent. ASCs and hospitals often use a single form both to verify that the surgeon obtained informed consent and to obtain general consent for care rendered at their facility. The patient is usually given this form to sign by a facility employee during the registration or admission process. To protect themselves against allegations of lack of informed consent, therefore, ophthalmologists should have the patient sign the procedure-specific consent form in their office and place it in the patient’s medical record.
Sterilization Breakdowns in Endophthalmitis/TASS
Anne M. Menke, RN, PhD, OMIC Risk Manager
Digest, Spring 2006
The malpractice case featured in this issue’s lead article stemmed from a series of breakdowns in the facility’s sterilization process. When notified of the problem, the physician consulted with the ASC’s medical director and together they decided not to alarm the patient until they knew the facts. By not warning the patient of the symptoms to watch for, they arguably missed an opportunity to diagnose the problem earlier.
Q Should I tell my patient of potential problems with sterilization?
A Yes for several reasons. Patients have a need and a right to know about their own condition and can help monitor the development of symptoms. Such disclosure of adverse events is best understood as a continuation of the informed consent process begun before the surgery. Moreover, communicating with the patient sympathetically and non-defensively within the shortest appropriate time period may help dispel much of the anger, confusion, and distrust that complications may engender, while preventing allegations of fraudulent concealment that could extend the statute of limitations or allow for punitive damages. Stick to the currently known facts, avoiding speculation or blame. As more information becomes available, share it with the patient and document it in the medical record.
Q How should I proceed if I suspect a cluster of endophthalmitis or TASS cases?
A You will need to coordinate with the facility, your staff, and your patients in order to respond effectively. All patients operated on that day need to be notified of the events, screened for symptoms, and educated about when and why to contact you. The facility needs to sequester all involved materials, interview staff, and evaluate equipment, devices, solutions, medications, and the sterilization process. The investigation will help locate the responsible organism or toxic agent, ascertain liability, and determine what steps to take to remedy any identified problems.
Q What specific information do I need to collect for the investigation?
A Nick Mamalis, MD, of the Intermountain Ocular Research Center at the University of Utah has developed an Excel-based protocol that can be used for individual or clustered cases of infectious or sterile endophthalmitis. Detailed information about each patient’s pre- and postoperative course, the facility, equipment, supplies, medication preparation, and sterilization technique are compiled, entered into the spreadsheet, and sent to the center for review. Research fellows are available for on-site evaluations, and charge only airfare and nominal expenses. In response to more than 80 TASS cases nationwide, the AAO and ASCRS announced in May 2006 that an ad hoc committee chaired by Dr. Mamalis had been established to help determine the causes. Ophthalmologists with TASS cases are urged to complete two short questionnaires about the products involved during cataract surgery and the actual process of cleaning and preparing instruments and patients for surgery and forward them to Dr. Mamalis. The protocols and questionnaires are available on the OMIC web site, via email at Nick.mamalis@hsc.utah.edu or by calling (801) 581-6586.
Q What measures can I and the ASC take to prevent TASS?
A While it can be very difficult to pinpoint the cause of TASS, pH, preser- vatives, and cleaning solutions are often implicated. Dr. Mamalis suggests a whole team approach to the order- ing, cleaning, sterilizing, and preparation of all instruments, viscoelastic, medications, and irrigation solutions to ensure proper pH, osmolality, and non-toxicity. Avoid re-use, especially of cannulas and damaged instruments. Rinse I/A tips and phaco hand pieces at the conclusion of each cleaning step with sterile, deionized water through both ports. Replace ultrasound water baths daily. Change the steam auto- clave sterilizer at least weekly. Take care with wound construction and avoid ophthalmic ointment and patches with clear corneal incisions.[1]
Q Does the OMIC endophthalmitis claims study identify specific ways that physicians can minimize their liability?
A Yes. Treat preexisting blepharitis. Screen for and stabilize medical conditions, such as immunosuppression or uncontrolled diabetes, that could adversely impact the patient’s healing process. Use povidone iodine to prepare the eyelid, carefully construct the wound, and check for leakage. Base your choice of antibiotic prophylaxis on current peer-reviewed recommendations. Provide written discharge instructions on wound care, signs and symptoms to report, and contact information. Carefully screen complaints from postoperative patients and evaluate the need to personally examine the patient. Following possible breaks in sterilization or clusters, consider examining or talking to the patient daily until infection/TASS has been ruled out or effectively treated.
1. Mamalis, Nick et al. “Review/Update: Toxic Anterior Segment Syndrome.” J Cataract Refract Surg Vol 32, February 2006:324-333.
Endophthalmitis/TASS Investigation Protocol
Please see attached.
Cataract Consent Form
> Click on “Recommendations” for OMIC recommendations related to cataract care.
> See also the Cataract: Patient Information Sheet, which gives more detailed information for patients about IOLs and astigmatism correction.
> Use toolbar to Download form and make changes. (Preview is displayed below)
INFORMED CONSENT FOR CATARACT SURGERY
WHAT IS A CATARACT AND HOW IS IT TREATED?
The lens in the eye can become cloudy and hard, a condition known as a cataract. Cataracts can develop from normal aging, from an eye injury, or if you have taken medications known as steroids. Cataracts may cause blurred vision, dulled vision, sensitivity to light and glare, and/or ghost images. If the cataract changes vision so much that it interferes with your daily life, the cataract may need to be removed. Surgery is the only way to remove a cataract. You can decide not to have the cataract removed. If you don’t have the surgery, your vision loss from the cataract will continue to get worse.
HOW WILL REMOVING THE CATARACT AFFECT MY VISION?
The goal of cataract surgery is to correct the decreased vision that was caused by the cataract. During the surgery, the ophthalmologist (eye surgeon) removes the cataract and puts in a new artificial lens called an intraocular lens or IOL. Cataract surgery will not correct other causes of decreased vision, such as glaucoma, diabetes, or age-related macular degeneration. Most people still need to wear glasses or contact lens after cataract surgery for either near and/or distance vision and astigmatism.
WHAT TYPES OF IOLs ARE AVAILABLE?
Your ophthalmologist will help you decide on the type of IOL that will replace your cloudy lens. There are IOLs available to treat nearsightedness (myopia), farsightedness (hyperopia), and astigmatism. IOLs usually provide either near or distance vision: these single focus lenses are called monofocal IOLs. Some newer IOLs can provide for near, intermediate, and distance vision: these multiple focus lenses are called multifocal IOLs. IOLs that treat astigmatism are called toric IOLs. You can also have one eye corrected for near vision, and the other for distance vision, a choice called monovision.
WHAT IS ASTIGMATISM? ARE THERE OTHER TREATMENTS FOR IT?
Patients with nearsightedness and farsightedness often also have astigmatism. An astigmatism is caused by an irregularly shaped cornea; instead of being round like a basketball, the cornea is shaped like a football. This can make your vision blurry. In addition to toric IOLs, astigmatism can be reduced by glasses, contact lenses, and refractive surgery (LASIK or PRK). There is also a procedure called a limbal relaxing incision (LRI), which can be done at the same time as the cataract operation, or as a separate procedure. A limbal relaxing incision (LRI) is a small cut or incision the ophthalmologist makes into your cornea to make its shape rounder. Any attempt at astigmatism reduction could result in over- or under-correction, in which case glasses, contact lenses, or another procedure may be needed.
WHAT ARE THE MAJOR RISKS OF CATARACT SURGERY?
All operations and procedures are risky and can result in unsuccessful results, complications, injury, or even death, from both known and unknown causes. The major risks of cataract surgery include, but are not limited to bleeding; infection; injury to parts of the eye and nearby structures from the anesthesia, the operation itself, or pieces of the lens that cannot be removed; high eye pressure; a detached retina, and a droopy eyelid. The major risks of a limbal relaxing incision are similar to those for cataract surgery, but also include loss of vision, damage to the cornea, and scarring; under- or over-correction could occur.
Depending upon your eye and the type of IOL, you may have increased night glare or halos, double vision, ghost images, impaired depth perception, blurry vision, and trouble driving at night. The ophthalmologist might not be able to put in the IOL you choose. In addition, the IOL may later need to be repositioned or replaced.
Depending upon the type of anesthesia, other risks are possible, including cardiac and respiratory problems, and, in rare cases, death.
There is no guarantee that cataract surgery or astigmatism reduction will improve your vision. As a result of the surgery and/or anesthesia, it is possible that your vision could be made worse. In some cases, complications may occur weeks, months or even years later. These and other complications may result in poor vision, total loss of vision, or even loss of the eye in rare situations. You may need additional treatment or surgery to treat these complications. This additional treatment is not included in the fee for this procedure.
PATIENT’S ACCEPTANCE OF RISKS
I understand that it is impossible for the doctor to inform me of every possible complication that may occur. By signing below, I agree that my doctor has answered all of my questions, that I have been offered a copy of this consent form, and that I understand and accept the risks, benefits, and alternatives of cataract surgery. I have checked my choice for astigmatism correction and type of IOL.
__________Monofocal IOL/Glasses Option
I wish to have a cataract operation with a monofocal IOL on my _______________ (state “right” or “left” eye) and wear glasses for _____________________ (state “near” or “distance”) vision.
__________Monovision with 2 IOLs Option (may still need glasses)
I wish to have a cataract operation with two different-powered IOLs implanted to achieve monovision. I wish to have my ______________ (state “right” or “left”) eye corrected for distance vision. I wish to have my ___________ (state “right” or “left”) eye corrected for near vision.
__________Multifocal IOL Option (may still need glasses)
I wish to have a cataract operation with a _____________________ multifocal IOL implant (state name of implant) on my _______________ (state “right” or “left”) eye.
__________Toric monofocal IOL/Glasses Option for Astigmatism Reduction
I wish to have a cataract operation with a toric monofocal IOL on my _______________ (state “right” or “left” eye) and wear glasses for _____________________ (state “near” or “distance”) vision.
__________Limbal Relaxing Incision for Astigmatism Reduction (may still need glasses)
I wish to have this procedure done in addition to the cataract operation.
Patient (or person authorized to sign for patient) Date
Reviewing Preoperative Test Results
By Marilys Fernandez, RN, JD
Digest, Spring, 1991
ALLEGATION Insured ophthalmologist failed to review a preoperative chest x-ray which was ultimately shown to be suggestive of carcinoma of the lung.
DISPOSITION Settled during trial.
Background
It is customary practice for ophthalmologists to routinely review results obtained from A-scans, visual field tests, fluorescein angiograms and a variety of other diagnostic tools prior to ophthalmic surgery. However, practices in reviewing chest x-rays and lab work routinely ordered preoperatively for patients undergoing surgery can vary considerably.
In a recent review of OMIC claims, reviewers identified a number of cases based on the ophthalmologist’s failure to review non-ophthalmological diagnostic studies. The resulting cases related to claims of missed diagnosis and delay in treatment, often of ailments unrelated to eye disease. The largest payment to date made on behalf of an OMIC insured was over $250,000 for injuries resulting from failure to review a preoperative chest x-ray which was ultimately shown to be suggestive of carcinoma of the lung.
Case Summary
The patient was a 60-year-old male who over the years developed age-related cataracts reducing his vision in both eyes. Cataract surgery was performed on the left eye with good results. Preoperatively, a chest x-ray was ordered by the ophthalmologist to comply with the hospital’s policy that such tests be performed on all surgical candidates over 40 years of age. The x-ray was interpreted by the radiologist as abnormal but was never reviewed by the ophthalmologist prior to surgery.
Four months later, the patient elected to have cataract surgery on his right eye. Another preoperative chest x-ray was performed which showed an enlargening left hilum with a lobulated mass present. The ophthalmologist was informed of the abnormal finding after the patient had been inducted but proceeded with the surgery anyway.
The chest x-ray taken prior to the first cataract surgery was then reviewed and found to indicate the presence of a nodular density in the left hilum. A later CT scan appeared to confirm that the mass had grown significantly in those four months. Following a left thoracotomy and pneumonectomy, the mass was found to be a poorly differentiated adenocarcinoma with four of eight hilar lymph nodes positive for metastatic cancer.
According to a pulmonary oncologist who reviewed the case, the first chest x-ray showed no metastasis to the nodes. Had the patient been treated at that time, he arguably might have had a 50 to 55 percent chance for a 5-year survival rate. With the four-month delay in diagnosis and treatment, the chances for a 5-year survival might have dropped to between 15 and 25 percent.
Outcome
Although there was potential exposure on the part of the hospital, anesthesiologist and radiologist for not being more aggressive in bringing to the attention of the ophthalmologist the results of the first chest x-ray, it remains the attending physician-surgeon’s responsibility to follow up on all tests ordered and to review the results of all preoperative tests.
After OMIC assessed the liability exposure of the case, the claims management staff entered into settlement negotiations with the plaintiff’s attorney and settled the claim with consent of the insured ophthalmologist.
The co-defendants involved, namely, the hospital, anesthesiologist and radiologist, refused to participate in settlement and were later sued by the patient. The outcome of that suit has yet to be determined.
Risk Management Principles and Commentary
This case presents a number of fundamental principles that ophthalmologists can follow to help avoid or reduce diagnosis-related claims. In particular, systems should be developed in the ophthalmic office to assure the efficient processing of all diagnostic clinical information.
Such systems could include:
- A method for ensuring that laboratory results, consultation reports and other pertinent documents are seen by the treating/attending physician before such information is filed.
- A reminder or diary system which ensures that follow-up tasks, such as notifying patients of test results, are undertaken when warranted.
- A formal arrangement whereby test results that are adverse or require immediate attention be reported personally by the consulting physician to the physician who requested them.
Additional suggestions may be found in the publication Risk Management Principles and Commentaries for the Medical Office published by the AMA/Specialty Society Medical Liability Project.
