Browsing articles from "May, 2012"

Collegial Criticism and the Courtroom

By Amy B. Angert, Esq.

Argus, Nov-Dec., 1994

Physicians and defense attorneys have no control over certain factors in a medical malpractice lawsuit, such as how a case proceeds and its overall strengths and weaknesses. Many crucial facts of a case are established before the first legal document is ever filed.

One area physicians can control, yet often unwittingly do not, is collegial criticism. The way a health care professional comments on a colleague’s actions can severely impact the course of a case. Collegial criticism involves comments or communication by one health care provider about another professional’s care made to the patient, to other health care professionals, or placed in the medical chart, as well as communication made at depositions or trials regarding a colleague’s course of action. These comments may even trigger a lawsuit.

Before giving sworn testimony, defendant physicians, expert witnesses and fact witnesses often have the chance to confer with defense counsel about sensitive issues and how to communicate these issues. However, long before an attorney is involved in a case, a physician may be in a position to render commentary about a colleague. This is the time to practice defensive medicine and to be sensitive about how your statements may sound later, if taken out of context.

In today’s practice environment, it is not unusual for one doctor or health care provider to render treatment in conjunction with or subsequent to another provider. Patients often will ask about the care rendered by a prior physician. The response can dramatically determine whether or not they file a lawsuit.

Inadvertent or deliberate critical comments by one health care provider concerning another are dangerous. These encourage claims by reinforcing in the plaintiff’s or the plaintiff attorney’s mind that someone did something wrong, or that this case will put defendants at odds with one another and almost assuredly will guarantee a hefty settlement or judgment at trial.

Fortunately, there are 10 simple commandments that should govern an ophthalmologist in this area. By employing these tenets religiously in your medical practice, you can eliminate most, if not all, problems associated with collegial criticism.

Thou Shalt Respect Thy Colleague

First and foremost, as a professional, it is your job to instill patient confidence in your colleagues and your profession. You need to be positive, both about yourself and the community in which you practice. It is important to refrain from editorializing about another’s care.

Thou Shalt Not Speak For Another Physician

This is probably the single most important commandment. Unless you were there as a practicing ophthalmologist to observe the care rendered by your colleague, it is inappropriate for you to speculate on another physician’s thought processes. You should encourage a patient who has a question regarding a previous or subsequent provider to talk with that doctor directly. At the very least, you need to get all the facts. Oftentimes, you are hearing a one-sided story without the benefit of the big picture.

Thou Shalt Educate Thy Office Staff

These commandments apply to the staff as well as to the ophthalmologist. You should instruct office staff on how to handle patient complaints and train them not to comment on any other provider’s care. Often, in an effort to comfort or empathize with a patient, staff will comment on the number of times they see another doctor’s mistakes, or they intimate that their doctor can rectify what the other physician has done wrong. Encourage your staff to think before they speak and to consider how their comments may be interpreted out of context or worse, in front of a jury.

Thou Shalt Record Events Factually, Only

Collegial criticism encompasses a multitude of areas, including the patient chart. This commandment mandates that the medical record contain relevant medical information only and not opinion testimony or personal comments. Personal comments or criticisms about the patient, other doctors or the hospital do not belong in the medical chart. While you may have a beef with the patient or with another physician, those issues are more appropriately handled outside the medical record. The record should reflect only the care rendered and issues pertinent to that care. Take time to record the rationale for your intervention, especially if it deviates from the usual course of treatment. This can help ward off criticism of your care by another health care provider or, at the very least, indicate the circumstances that require this treatment modality.

Thou Shalt Communicate With The Other Doctor

This is especially important when you are asked to give a second opinion. Make sure you have all the facts before you render commentary regarding your colleague’s care. If possible, confer with the other provider to find out the rationale and considerations for the care rendered. When giving advice to patients, keep your advice factual and avoid commenting on another’s care.

Thou Shalt Not Covet Others’ Patients

This commandment speaks for itself. Criticizing a colleague to steer patients your way will eventually backfire. It becomes a double-edged sword with repercussions. You will lose respect among your colleagues in the ophthalmic community-and you may open yourself up for a defamation case or worse.

Thou Shalt Recognize That Good Doctors Can Disagree

Medicine is an art as much as a science. There is a respectable minority recognized in medicine, and what works in one ophthalmologist’s practice may not work as well in another’s. Criticizing your colleague’s judgment may imply a warranty or a guarantee that you cannot live up to. In other words, your criticisms may imply that you can do it better or that your care will render a different outcome. Beware.

Thou Shalt Recognize Thine Own Mistakes

Before commenting on a colleague’s actions, remember you may not have all the facts. You could end up eating your words and defending a suit against yourself later. At first blush, you may disagree with a particular physician’s course of action. However, after obtaining the necessary information, tests and history, you may come full circle and agree with your colleague’s course of treatment or action. It is extremely difficult to retract your comments once critical words have left your lips. If your treatment does not provide the results expected by the patient, you may be in worse shape than your colleague.

Thou Shalt Keep The Other Doctors Informed

Whether you have been asked to take on a new patient who is leaving a previous doctor’s care or to offer a second opinion, try to get the patient to agree to allow you to speak with the other health care provider. This not only fosters good community relations and keeps the line of communication open, it also provides you with a source of information and knowledge which may shed light on your care of the patient. This may not always be possible, but you should make every attempt to be sensitive to your colleague’s situation as well as to the patient’s wishes.

Thou Shalt Not Make Unnecessary Enemies

What goes around comes around. During a recent deposition, an ophthalmologist, against his attorney’s advice, vigorously criticized the HMO he had recently left. Although he was only being deposed as a fact witness (treating physician) at the time, the case took a twist and the doctor was added to the lawsuit-not by the plaintiff, but by the HMO.

Faulty A-Scan Readings Present Potential Liability

By Jean Hausheer Ellis, MD

Argus, April, 1994

A-scan Biometry, used to measure axial length in calculating intraocular lens power, presents potential liability hazards for the ophthalmologist. Axial length measurement is one of several important factors influencing the accuracy of intraocular lens power calculation. Myopia or Hyperopia induced because of inaccurate measurements are unpleasant postoperative surprises, unacceptable to patients and ophthalmologists.

Current ultrasound techniques allow better pre-op measurements with a possible accuracy or reproducibility to within 0.1 mm or less in axial length measurement. An error of 0.1 mm in axial length measurement preoperatively has been known to cause a postoperative refractive error of 0.25 diopters. The current standard of care calls for performing preoperative ultrasound and axial biometry rather than using a “standard lens power” based only on the preoperative refractive error.

Thanks to improvements in ultrasound technology and equipment over the years, the trained ophthalmic assistant or the ophthalmologist can more reliably and more predictably perform this test in the office or the hospital. Advancements in intraocular lenses require increased precision in axial length measurements, especially with multifocal intraocular lens designs. As ophthalmologists continue to closely track their postoperative refractive results and compare these to the desired preoperative refraction, they must pay closer attention to techniques, data interpretation, instrumentation and bilaterality of axial length measurements, as well as to which examiner is the most reliable, precise and reproducible tester.

A frequent risk management question is, who should perform the ultrasound and axial length measurements, the ophthalmologist or trained staff? As “captains of the shop,” ophthalmologists are responsible for staying current in their knowledge and understanding of this area. They typically oversee the work of their staff, check for errors (before the wrong lens implant is inserted in the eye), and are proficient at repeating the measurements in difficult eyes or when results are questionable.

It is wise to develop a “check and balance” system for taking and interpreting these measurements so they can be double-checked and rated as to their “ease” or “difficulty.” One suggestion is that the examiner record each individual measurement and rate each as “easy,” “medium” or “difficult” (A, B or C) in the patient record to better assure selection of the best one. In borderline cases, with difficult eyes, or when test results appear unusual, the measurements can be repeated by another individual and the results compared.

Should ultrasound and axial length measurements always be taken bilaterally? The answer is “yes” with only a few exceptions-one-eyed patients and pseudophakic second eyes. In pseudophakes whose previous measurements were taken elsewhere, attempts can be made to obtain previous biometry information and compare preoperative values for the two eyes. While reviewing a patient’s previous axial measurements can be helpful, you should perform your own ultrasound and axial length measurements to ensure reliability and reproducibility. Do not accept someone else’s measurements at face value. Even if you checked these measurements on the same patient several years ago, it is prudent to repeat the test as a quick check of yourself, your staff and your equipment. It is far less costly to retest the patient at no charge and to find that an error was made in the previous measurements than to have an unacceptable postoperative refractive error based on faulty measurements-a result that may lead to a malpractice suit.

If you are thinking about upgrading your equipment, consider a water immersion probe. It will not compress the cornea and, when combined with a standard contact probe, allows more flexibility. Since the ophthalmologist is ultimately responsible for thoroughly reviewing all measurements and ultrasonic data, look for equipment that can photograph test results. This serves as a useful guide and monitor, both pre- and postoperatively. Multiple readings are best, with the ophthalmologist choosing the ultimate test result. Creating a system for double-checking this information as it is entered into the lens implant calculation is well advised, again to reduce the chance for human error.

Ultimately, the ophthalmologist needs to be fully aware of who is performing these important measurements. Some hospital facilities routinely used trained staff members to perform these tests. While most will be accurate and reliable, your patient is best served when tested by someone who is experienced and not by someone who is new or in-training, without your prior knowledge or consent. Occasionally, the referring optometrist may perform and bill for preoperative ultrasound and axial measurements. Depending on the optometrist’s experience, it may be prudent for the ophthalmologist to repeat these measurements.

Good supervision, attention to detail, and routine checks and balances should be the rule when performing ultrasonic testing and biometry measurements. Periodically review the literature for current medical standards to increase the likelihood of a positive surgical outcome and to minimize or prevent malpractice claims.

In-Office Lasers: You Could Get Burned

By E. Randy Craven, MD

Argus, July, 1994

Portable lasers may provide for convenience, but they also mean added legal obligations. Here’s some of the issues:

General Liability Duties

General liability duties increase with personal ownership of laser equipment. General liability refers to incidents not directly related to the care of the patient, e.g., a patient falls over some furniture in the waiting room. Among the general liability duties associated with laser ownership are properly maintaining and managing the equipment and ensuring that office staff are made aware of the hazards of working around the laser. To understand proper use and maintenance, thoroughly review the user’s manual.

Accidental Exposure to Laser Energy

Ophthalmologists must take precautions to prevent accidental exposure of laser energy to the eye and skin from either direct or diffusely reflected laser beams. When operating the laser, close the treatment room door and post a large sign stating “laser in use.” Place protective eyewear outside the door for personnel to put on before entering the room. Wavelength-specific goggles can be purchased through the manufacturer. Some manufacturers recommend door interlocks to automatically disable the laser when the treatment room door is opened.

Window coverings like hospitals use to cover operating room windows during laser procedures may be needed if the laser is located in a ground floor office near an outdoor public walkway.

Proper Maintenance

For continued reliability, follow the manufacturer’s recommended maintenance guidelines and ensure that a trained technician performs scheduled maintenance. Failure to do so may put the ophthalmologist at risk if a claim arises from a laser malfunction. Fortunately, most laser malfunctions are not likely to lead to a patient injury.

A preoperative check list or “flight plan” for double-checking the laser prior to use will help ensure a smooth procedure. The list should include spot size, power setting, pulse duration, wavelength, and proper alignment and delivery of the energy to a test object. Including this protocol in the office manual provides written documentation that a protocol is followed.

Informed Consent

The extent of potential hazards to the patient depends on the type of laser and its therapeutic application. Inform patients of the specific risks associated with a proposed treatment. For example, a trabeculoplasty carries significantly different risks than a panretinal photocoagulation. Common risks associated with lasers are overexposure, underexposure, reflection of the laser to unintended tissue site and thermal damage. Clearly communicate to the patient that any of these can cause major tissue damage, including vision impairment or blindness. Inform patients that, depending on the type of treatment, complications could occur weeks, months or even years later.

One potential informed consent issue is the need to obtain separate consent for multiple laser procedures. While obtaining informed consent each time the ophthalmologist uses the laser is probably not necessary, if the physician anticipates multiple procedures, inform the patient before treatment begins. As with any procedure, provide the patient with progress reports to avoid an unpleasant surprise or disappointment if laser therapy must be repeated.

Another issue concerns “piggybacking” consents, such as assuming that a cataract surgery consent form covers consent for a YAG laser capsulotomy procedure. A laser capsulotomy is a separate identifiable risk; if it is not specifically identified as part of the cataract surgery consent, it needs to be discussed with the patient prior to the YAG procedure. Document this discussion in the patient’s record.

The fact that the ophthalmologist and the patient discussed the potential risks of laser surgery and that the patient understood these risks should be clearly documented in the medical record and on an informed consent form. To request a model consent form addressing the clinical risks of laser surgery, call OMIC’s Risk Management Department, 1-800-562-6642 option 4.

Will FDA Regulations Preempt Personal Injury Suits?

By Elizabeth C. Moran, JD

 Digest, Winter, 1996

In January 1996, the U.S. Supreme Court agreed to decide whether FDA regulation of medical devices precludes patients from bringing strict liability, negligence, and other common law claims for injuries caused by improper design, manufacture, or labeling of medical devices.

In Lohr v. Medtronics, Inc., the plaintiff claimed she was injured by an unsafe pacemaker, a Class III device which had been marketed under the abbreviated Section 510(k) procedure as “substantially equivalent” to previous pacemakers.

Applying the Medical Device Amendments of the Food, Drug and Cosmetic Act, which prohibit states from imposing regulations on medical devices that are “different from or in addition to” federal regulations, the U.S. Court of Appeals for the Eleventh Circuit determined that because the FDA imposed specific regulations on the manufacture and labeling of the device, injured patients cannot sue the manufacturers for manufacturing defects or inadequate warnings. The Court held, however, that claims relating to improper design of the pacemaker still could be pursued because the FDA had not imposed any specific requirements governing design.

Over the past several years, the courts have issued widely divergent and conflicting decisions in this area. For example, the Ninth Circuit recently held, in Kennedy v. Collagen Corp., that the Medical Device Amendments do not preclude personal injury suits at all but are intended to prevent states from enacting statutes and regulations that apply specifically to medical devices.

Some courts have held that certain kinds of injury claims are preempted for Class III devices that have gone through full Pre-Market Approval, but not for devices, such as Class II devices, that are subject to lesser regulation. Other courts have held that there is no preemption unless the FDA has enacted regulations specific to a particular device, such as the specific requirements for warnings on tampons and hearing aids. Still others have applied the doctrine of preemption broadly, concluding that the FDA’s general requirements for manufacturing procedures and labeling, which apply to all medical devices regardless of classification, preclude most, if not all, common law injuries.

The Supreme Court’s decision will have a profound effect upon the scope of litigation involving medical devices.

If the Court applies preemption broadly, as many lower courts have done, device manufacturers will be largely insulated from liability. However, the physician who uses the device remains a potential defendant — perhaps the only “deep pocket” — under theories of medical negligence and lack of informed consent.

Criticism Aimed at Colleagues Can Prompt Malpractice Litigation

By William D. Noonan, MD, JD

Argus, January, 1996

One of the legal dangers in a managed care environment is that eye patients are sometimes given inadequate or inappropriate eye treatment by primary care physicians and nurses before they are referred to ophthalmologists for definitive care. As a result, eye specialists are more likely to see advanced cases or inadequately treated patients who are at greater risk for an unfavorable outcome that could result in malpractice litigation.

The specialist’s initial reaction may be smug satisfaction that primary care physicians and nurses will have to bear the legal consequences of providing specialized eye care without specialized training. This satisfaction evaporates, however, when the ophthalmologist is also named as a defendant in a lawsuit even though his or her only role may have been to improve the situation as best as possible. When lawsuits are filed, almost every professional person who participated in the care of the patient may be named as a defendant. Hence, it can be an act of self-preservation to resist the urge to share with any patient your opinion that a previous treating physician provided substandard care.

This is illustrated by the case of a 39-year-old woman who was hammering a nail into a bookcase when the nail flipped back against her left eye. A primary care physician evaluated her that same day in an emergency room. The physician instilled fluorescein in her eye and diagnosed a corneal abrasion. Visual acuity was not determined. She was treated with gentamicin ointment, a cycloplegic and a narcotic analgesic, and told to consult an ophthalmologist if the eye was unimproved the following day.

The next afternoon she was seen in an ophthalmology clinic, complaining of unremitting left eye pain and visual loss. Visual acuity in that eye was count fingers at one foot, and she had marked periorbital edema, chemosis and conjunctival injection. On slit lamp exam, there was a corneal laceration and a clear defect in the iris at 5 o’clock. The lens was completely opaque, intumescent appearing, and 5mm thick by ultrasonographic examination. The corneal wound was Seidel positive, and there was 1+ cell and flare in the anterior chamber. Intraocular pressure in that eye was 28. The patient underwent cataract extraction with repair of the corneal laceration. Her postoperative recovery was uneventful with eventual visual acuity of 20/25.

The primary care physician had incorrectly diagnosed the patient’s ruptured globe as a corneal abrasion, in spite of an obvious hole in the iris. This oversight delayed primary closure of the wound and exposed the patient to an increased risk of endophthalmitis. Although the patient was fortunate to have a favorable visual outcome, there was a risk of unnecessary blindness. At first it would seem that the ophthalmologist could best be insulated from liability by informing the patient that her injury had been misdiagnosed, but that everything possible would now be done to save the vision in her eye.

That kind of candor, however, only tends to promote malpractice litigation. Many patients who would not otherwise consider litigation are prompted to sue when a physician criticizes the care previously provided by a colleague. Once litigation is initiated, even the “blameless” specialist who fixed the problem may be named as a defendant.

Hence, the safest course for reducing one’s risk of litigation and legal liability is to carefully document the patient’s condition on presentation, provide high quality care with a realistic assessment of probable outcomes, and accurately present the facts of the situation to the patient while refraining from criticizing a medical colleague. Not all diagnostic errors are ipso facto negligence; therefore, it is always best to limit discussions with the patient to findings supported by objective data and to avoid speculation. If the patient questions the care of another health care provider, encourage the patient to talk directly with that provider.

It is naive to believe that less criticism of colleagues will eliminate or even substantially reduce medical malpractice litigation. A patient with postoperative endophthalmitis who undergoes enucleation knows something went wrong and will not need prompting to consider legal action.

But a variety of other conditions (such as missing an early diagnosis of glaucoma or overcorrecting a radial keratotomy) are within the realm of competent, but less than optimal, ophthalmic care. Patients may be dissatisfied with such an outcome but reluctant to consider litigation until given “permission” by a critical subsequent ophthalmologist. Under these circumstances, it is important to refrain from criticizing a colleague and to help maintain civility in medicine even as the profession is increasingly turned into a business by health care companies.

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