Personal Relationship with a Physician-Patient Clouds Judgment on Documentation

By Ryan Bucsi, OMIC Senior Litigation Analyst

 Digest, Summer 2009

ALLEGATION: Failure to educate patient on the symptoms and urgency of treatment for a retinal detachment.

DISPOSITION: The case was settled for $300,000 at mediation.

Case Summary

An OMIC insured examined a physician colleague he had known professionally for several years. The examination took place in the insured’s office. Indirect ophthalmoscopy revealed a “definite small vitreous hemorrhage,” but no holes or tears were noticed OS. A follow-up examination was scheduled for three weeks. Exactly two weeks after the initial exam, the patient was out of town when he experienced a progressive decrease in vision and total vision loss OS. He did not report the vision loss until six days later when he returned to the insured’s office one day prior to his scheduled appointment. The patient was seen by a partner of the OMIC insured, who diagnosed a retinal detachment involving the macula with a large circumferential tear along a vessel. Surgery was performed the same day and the retina was successfully reattached; however, the patient was left with 20/70 corrected visual acuity OS, which was deemed the maximum medical improvement. As a result of his decreased vision, the patient retired from medical practice and sought recovery under two disability insurance policies.

Analysis

The patient sued the OMIC insured over standard of care issues. At question was whether the insured discussed the symptoms of a retinal detachment and if he relayed the importance of immediate treatment if the patient experienced a loss of vision. There were no concerns about the insured’s examination of the patient; however, a record keeping issue directly impacted the standard of care. The patient informed the insured, after the fact, that one day before his initial visit he had hit his head on a heavy flower pot while gardening. The patient thought this was most likely responsible for his vision loss, and, under one of his disability policies, a “sudden or accidental” injury would allow him to collect more money.

The insured stated that the patient had drafted a written narrative about striking his head as this would likely benefit him with regard to obtaining the disability monies and had requested that the narrative be placed in his medical record. unfortunately, the insured then removed his initial documentation and created a second chart note of the visit. This note included the patient’s narrative and added that the patient was told to immediately contact the insured if there were any signs of a retinal detachment, such as a sudden loss of vision.

This presented a problem for the defense in that the original chart note did not make any mention of the insured explaining the symptoms of a retinal detachment to the patient, while the second note, which the patient allegedly requested, did. The insured maintained that he did not intentionally fabricate or in any manner embellish the findings of his examination, but had changed the record as an accommodation to his colleague. The plaintiff contended that he did not ask the insured to make any changes to the record and that the insured was covering his tracks and had altered the record in order to boost the defense’s position. Defense counsel advised OMIC and the insured that his story about trying to help out a colleague would not be well received by a jury and that alterations or additions to a chart, especially ones perceived as self-serving, usually reflect unfavorably on the defense. The insured agreed to settle.

Risk Management Principles

This case illustrates how physicians can get into trouble when they let personal relationships cloud their professional judgment. It is vital that ophthalmologists treat and keep records on patients they know (friends, family, or office staff) just as they would any other patient. Often, documentation is sparse or nonexistent when a physician has an outside relationship with a patient. In this case, the collegial relationship between the insured and the patient led to a breakdown in record keeping such that vital information about what was said during the initial visit was not recorded in the original documentation. When the insured then attempted to change the record after the follow-up visit, he dealt a death blow to his later defense of this claim.

Dispute Over Informed Consent with Elderly Patient

By Ryan Bucsi, OMIC Senior Litigation Analyst

Digest, Fall 2010

ALLEGATION: Failure to provide adequate informed consent resulting in the loss of peripheral vision.

DISPOSITION: The case was tried and a defense verdict was returned.

Case Summary

At the time of this incident, the plaintiff was 80 years old with a significant history of macular degeneration Ou with central vision loss OD. The insured’s exam, which included a fluorescein angiography and an explanation of advanced macular degeneration, revealed that the patient had developed neovacularization OS causing a sudden drop in visual acuity from 20/70 to 20/200 with a large amount of submacular blood. The insured recommended evacuation of the blood to prevent the development of scar tissue and to preserve central vision. The insured documented in the patient’s record that he “Advised vitrectomy with evacuation of subretinal blood and risk of subretinal blood involved.” However, no procedure-specific consent form was obtained. Approximately two weeks after this examination, the insured performed a vitrectomy and membrane peeling OS to evacuate subretinal blood, which was a relatively new treatment at the time. Postoperatively, the patient had two retinal detachments OS and eventually lost both central and peripheral vision OS.

Analysis

The main dispute in this case was over informed consent. Both the plaintiff and her daughter, who was present during the insured’s examination, claimed the ophthalmologist never told them that a postoperative retinal detachment could lead to peripheral vision loss. The insured adamantly denied the allegation and specifically recalled discussing these risks with the patient; however, his documentation outlining the risks of surgery was cursory. The defense was also compromised because the only consent form signed by the patient was a general surgical consent form in the hospital chart. Furthermore, the plaintiff was a sympathetic witness and her daughter verified her testimony. Defense counsel reported to OMIC that there was a 50% chance for a defense verdict in a somewhat conservative venue. There was little question that the retinal detachment occurred because surgery had been performed.

No one disputed that if the insured had not performed the surgery, this patient’s retina would not have detached and she would still have peripheral vision OS. However, without the surgery, the patient would have lost the chance to regain any useful central vision OS.

Just prior to trial, the plaintiff attorney, who was married to the plaintiff’s daughter, withdrew as counsel. Defense counsel warned OMIC prior to trial that the new plaintiff attorney was more formidable and that if a jury returned a plaintiff verdict, it was likely to be significantly higher. During the trial, plaintiff counsel approached defense counsel to initiate settlement discussions. The insured remained confident in his care and continued to oppose any settlement. A 7–1 defense verdict was returned in favor of the insured. The defense was able to convince the jury that the informed consent process took place even though the insured’s consent documentation was minimal. The defense was strengthened by the insured’s extremely credible testimony coupled with the fact that surgery was the only hope for saving the patient’s central vision. By the time this case went to trial, the plaintiff had some memory problems and was only able to recall the facts that supported her claims, which may have diminished her credibility. Following the jury verdict, OMIC defense counsel commented that it was very likely that this case would not have even been litigated if the OMIC insured had obtained a procedure-specific consent form from the patient.

Risk Management Principles

Informed consent is a process that requires more than simply obtaining the patient’s signature on a consent form. Detailed documentation of the indication for the procedure as well as documentation of all of the risks, benefits, and alternatives to the surgery are vital components of the informed consent process. Documentation of the consequences for delaying or refusing treatment is also advisable. In this case, the insured should have discussed and clarified with the patient and her daughter the ultimate goal of surgery—preservation of central vision—and documented in the chart that they were all in agreement with that goal and understood why surgery was being performed. The insured should have required the patient to sign a procedure- specific consent form and documented the patient’s understanding that this was a relatively new procedure.

Informed Consent: A Process, Not Just a Legality

By James F. Holzer, JD

[Argus, March, 1991]

Most ophthalmologists and risk managers agree that a significant number of malpractice claims are precipitated by a patient’s surprise over unexpected adverse outcomes and unfavorable provider-patient rapport. This is particularly true with relatively high volume procedures such as cataracts where some patients may unrealistically expect perfect clinical results. Indeed, over half of all malpractice claims filed against OMIC policyholders related to cataract surgery, according to a survey of 236 cases filed from October 1987 through September 1990.

Unfortunately, busy schedules and time-consuming administrative duties can make it difficult for ophthalmologists to develop the dialogue necessary to minimize unrealistic patient expectations. In response to these issues, a new school of thought has evolved concerning the use of informed consent as a way to improve this dialogue.

Rather than being a purely legal function performed under time-constrained conditions, informed consent should be regarded as a process which begins during the first patient-physician encounter, and continues through the operative and postoperative phases of treatment. Forms and signatures merely become a part of the process, and not the focus of it. Thus, consent becomes an opportunity to establish a “therapeutic alliance” between ophthalmologist and patient, addressing two of the most significant problems in health care risk management today: communication and rapport.

Further, this ongoing dialogue between ophthalmologist and patient in which clinical uncertainty and risk is squarely acknowledged and shared, makes informed consent a powerful tool in dealing with patient surprise and anger over unexpected adverse clinical outcomes and iatrogenic events.

Although consent forms continue to have legal significance, the use of such documentation becomes more meaningful when used as supplemental tools to help educate patients and provide ophthalmologists with what the law calls a “written memorialization” of dialogue. A number of ideas and suggestions for implementing the “process” model of informed consent were discussed by the author in a recent edition of the Bulletin of the American College of Surgeons:

• Office support staff such as nurses, paramedical personnel and administrative assistants should be encouraged to shift their focus from the “paperwork of consent” to the ongoing “process.” Remember, documentation is critically important, but is not the sole objective of this effort.
• When possible, start the consent process as early in the continuum of care as possible. This doesn’t necessarily mean an immediate recitation of the risks, benefits and alternatives to treatment, but rather an interactive exchange of relevant information designed to mutually explore expectations and understanding of pertinent clinical issues.
• During the initial or subsequent office visit, explain the purpose of the consent form. Then give the patient a copy! A teaching hospital in the East that specializes in ophthalmic surgery has been providing copies of its risk-specific forms to patients for years without any known adverse medical-legal consequences.
• When possible, make contemporaneous notes in the patient’s record and/or your office records during all phases of the consent process.

By shifting the focus of consent as a single event to consent as an ongoing process of shared information and decision-making, ophthalmologists can collaboratively work with their patients to eliminate many of the factors that trigger a significant percentage of malpractice claims. In the process, the so-called burden of informed consent can become a learning opportunity for both the ophthalmologist and patient.

Practical Approaches to Informed Consent in Ophthalmic Practice

By James F. Holzer, JD

[Digest, Summer, 1992]

Almost 90% of the ophthalmic malpractice claims closed by OMIC during the past five years were terminated in favor of the ophthalmologist without any indemnity payment made on behalf of the insured. Although these preliminary statistics bode well for ophthalmologists in general, there remains the nagging question: Why were such actions filed in the first place if there were insufficient legal grounds for plaintiffs to succeed?

Assumptions that most patients are motivated by personal greed, hungry lawyers, or both, are unproved at best and “anti-patient” at worst. The simple fact is that many patients sue, regardless of negligence, because they are surprised by the clinical outcome and angry with the provider they believed to have caused it.

Recent literature continues to suggest that most patients and their families who file malpractice claims believe physicians did not warn them about the potential medical problems following a treatment or procedure or that doctors tried to mislead them.¹ Oftentimes, the decision to sue or not comes down to whether the patient believed the physician cared about them personally. A study of patients who experienced adverse clinical outcomes indicated that patients who chose to file a malpractice claim perceived their physicians as uncaring compared to those patients who elected not to sue.²

The best constructed legal consent form in such situations is virtually powerless to forestall litigation triggered by such emotional factors. Yet, a consent form, coupled with the patient’s perception that important clinical information was personally conveyed by a caring physician, could very likely prevent many unexpected medical outcomes from ever developing into formal claims.

Conveying Caring Attitudes with Information

As some authors suggest, a physician who expressly acknowledges clinical uncertainty and empathizes with a patient’s wish for certainty paradoxically forms a type of therapeutic alliance or bond which many patients will perceive as a caring and personal attitude.³ Such interaction prevents informed consent activities from becoming mere episodic “events” which occur only when someone signs a consent form.⁴ Instead, consent activities take place during a “process” that begins with the first patient encounter and continues through the operative and postoperative treatment phase of care. Forms and signatures become merely an end-stage culmination of the process, not the focus of it.⁵

Integrating Process and Form

Since informed consent is still regarded in many ophthalmic practices as a discrete legal event rather than an interactive process, it is important to change the mind-set of the entire patient care team while at the same time altering procedure. Suggestions on how this might be done have been discussed by this author and others in recent editions of ARGUS, the Bulletin of the American College of Surgeons and other periodicals: ^{6, 7, 8}

1. Office support staff such as nurses, paramedical personnel and administrative assistants must first be encouraged to shift their focus from the “paperwork of consent” to the ongoing “process.” Documentation is important, but not the sole objective during this phase of the process.
2. When possible, start the consent process (the sharing of pertinent information) as early in the continuum of care as possible. This doesn’t necessarily mean an immediate recitation of the risks, benefits and alternatives to treatment, but rather an interactive exchange of relevant information designed to mutually explore expectations and understanding of pertinent clinical issues. In studies cited earlier in this article, almost a third of the patient families involved in the survey perceived that their doctors would not talk or answer questions. Many believed no one was listening.⁹
3. In appropriate situations, try to make arrangements to have family members present and included when discussing the patient’s disease process, planned medical treatment or surgery.
4. During the initial or subsequent office visit, introduce the consent form and explain its purpose. Clarify for the patient that the form is intended to help assure both patient and ophthalmologist that important facts which matter to the patient have been discussed and are understood.
5. Be frank and honest about clinical uncertainties, but don’t overcompensate by avoiding the potential benefits of treatment either.
6. Next, give the patient a copy of the form or documentation, either before or after it is signed. Contrary to the belief of many ophthalmologists, an adversarial note is intoned not as the form is being signed, but when a copy is not made available or graciously offered to the patient. This is important since some studies suggest that patients believe doctors cover up or downplay important information. Fear about giving patients a copy of the consent form is usually worse than the reality. A major teaching hospital specializing in ophthalmic surgery has been providing copies of its risk-specific forms to patients for over seven years without any known adverse medicolegal consequences.
7. If patients appear troubled over the risks and uncertainties of treatment, empathize with their wish for a good result without making any unrealistic assurances. Accept their ultimate decision, even if it doesn’t agree with yours. In most situations, this is their right under the law. If the consent “process” was properly handled as described earlier, there should be no animosity.
8. When possible, make contemporaneous notes in the patient’s record and/or your office records during all phases of the consent process, even if a form is used.

The Legal Face of Consent

Ironically, very few medical malpractice cases lost by physicians are solely related to the legal doctrine of informed consent. Yet, it is these legal components and the language of consent forms that dominate risk management seminars and instructional advice from professional liability insurance carriers. Clearly, more malpractice cases with consent issues are lost for reasons related to defective process and communication rather than defective forms or legal requirements.

As a starting point, however, it is still necessary for ophthalmologists to understand some of the basic legal fundamentals behind consent case law. As a general rule, most states are adopting what some experts call the “patient viewpoint” standard in that the type of information disclosed should be based on what a reasonable person in the patient’s position would want to know in similar circumstances. This is contrasted with the less popular “reasonable physician” standard which defines disclosure based on what a reasonable practitioner in the medical community would customarily disclose under the same or like circumstances.¹⁰

Although the law may vary from state to state, ophthalmologists have a non-delegable duty to disclose and discuss with patients:^{11, 12, 13}

• The ophthalmologist’s diagnosis;
• The nature and purpose of the proposed treatment or procedure;
• The risks and benefits of the proposed treatment or procedure;
• Alternative methods of treatment and the risks and benefits of such alternatives;
• The risks and benefits of no treatment.

The best way to document such information and, more importantly, to record that the consent process took place, is still through the use of a pre-established form. Recognizing that this statement is as welcome to ophthalmologists as another reimbursement law, it is incumbent on all members of the practice management team to regard such documentation not as just another form to complete, but as an important informational tool to recognize and confirm the existence of a strong therapeutic alliance between ophthalmologist and patient. (See pages B-9, B-10)

A so called “short-form entry” in the medical record which simply states that “the risks, benefits and alternatives have been explained to the patient” cannot effectively convey the care and attention that has been paid to the consent process. Until handwritten entries can be improved to the level where their evidentiary value consistently exceeds that of a properly developed preestablished document, the use of a consent form for most operative procedures is still the best way for ophthalmologists to document the process.

Model Forms

There is no one right or wrong answer in designing an ophthalmic consent form. Like all parts of the medical record, the consent form must represent that the ophthalmologist made a reasonable effort to effectively carry out this important duty as part of the patient’s ongoing care.

A number of ophthalmic-specific forms, which have been used as attachments to general forms, are reprinted with this article (see page B-7) and can serve as a model for ophthalmologists seeking to develop specialized documents for their practice. In reviewing model forms, practitioners should recognize that no single form can be designed to meet the peculiar legal requirements of each state. Physicians should consult with their legal advisor to determine if there are particular aspects of state law that ought to be addressed in the documentation. However, these reprinted forms do contain the general elements necessary to document the consent process and address legal requirements as well.

Additional sample consent forms used in ophthalmology have been distributed as part of OMIC’s series of risk management educational seminars. Copies of the educational handouts on consent are available without charge to OMIC insureds and for $6.00 to non-insureds by writing the OMIC executive office at 655 Beach Street, San Francisco, CA 94109-1336.

By effectively integrating the consent process and form, ophthalmologists can begin to address the important risk management goals of enhancing patient communication while potentially reducing the growing number of time-consuming and costly malpractice claims precipitated by patient surprise and bad feelings.

Click here to view sample consent forms and other documents for the ophthalmic practice.

 Notes:

1. Hickson GB, Clayton EW, Githens PB, et al. Factors that prompted families to file medical malpractice claims following perinatal injuries. JAMA. 1992;267:1359-63.
2. May ML, Stengel DB. Who sues their doctors? How patients handle medical grievances. Law Society Review. 1990;24:105-20.
3. Gutheil TG, Burszatjn H, Brodsky A. Malpractice prevention through the sharing of uncertainty. N Engl J Med. 1984;311:49-51.
4. Lidz CW, Appelbaum PS, Miesel A. Two models of implementing informed consent. Arch Intern Med. 1988;148:1385-89.
5. Holzer JF. The process of informed consent. Bull Am Coll Surgeons.
6. See note above.
7. Holzer JF. Informed consent: A process, not just a legality. ARGUS. March 1991:20.
8. Redmond MR. Patient’s anger could land you in court. ARGUS. July 1991:15.
9. See note 1 above.
10. Risk Management Principles & Commentaries for the Medical Office. American Medical Association/Specialty Society Medical Liability Project, Chicago. 1990:2.01-2.06.
11. See note 10 above.
12. Rozovsky FA. Informed Consent. Risk Management for Healthcare Facilities. American Society for Healthcare Risk Management and the American Hospital Association, Chicago. 1990:179.
13. Campion FX. Grand Rounds on Medical Malpractice. American Medical Association, Chicago. 1990:112.

Most Frequently Asked Questions About Informed Consent

By James F. Holzer, JD

[Digest, Summer, 1992]

Q  Do I need to get informed consent for every single procedure I do?
A  This is actually a misleading question. The correct answer is that physicians must always get informed consent for every treatment, procedure or test, regardless of how simple. How extensive the documentation should be, however, will vary with the type of procedure being performed.

Most ophthalmologists who ask this question are really asking whether a form has to be used for every single procedure, and clearly the answer is no. Most surgical procedures requiring general anesthesia and selected major procedures under locals, including cataract extractions, should have the consent process comprehensively documented on a form. Consent for other minor treatments, including many brief office procedures, can generally be recorded as a thorough note in the patient’s chart.

It is important to remember that “patient consent” first occurs verbally during the process. The signature on a form, or entry on the chart, merely memorializes in writing the patient’s decision and the fact that the consent process took place.

Q  How much information do I ultimately have to convey about the risks of a procedure?
A  Unfortunately, the answer is “it depends.” Many states provide little guidance to physicians about the amount and type of information necessary to satisfy a legal challenge. Most jurisdictions now indicate that “material” information be disclosed to the patient. The term “material” generally means information that a particular patient might consider significant in deciding whether or not to undergo the procedure or treatment. The doctor is not required to be a mind reader or to provide a “minicourse in medical science.” Some courts have even formally opined about not making a consent obligation an “undue burden on physicians.” Clearly, many juries and courts may look at the manner and extent of the consent documentation more as an indicator of a doctor’s overall credibility with respect to the time and attention he or she spent with the patient.

Q  Have many malpractice cases been lost solely on the issue of informed consent?
A  No, because a legal allegation of improper consent is usually accompanied by numerous other complaints. Juries, as a general rule, do not have to specify which pieces of evidence or allegations they regarded as most significant in determining that a doctor was negligent. More often than not, problems surrounding the consent process are aggravating or complicating factors which interfere in the successful defense of a malpractice claim. That’s why documentation which shows good consent process can play a significant role in supporting the physician’s overall believability and credibility if a claim does go into litigation.

Q When should informed consent and accompanying documentation be obtained from the patient?
A For elective procedures, the process should be started at the earliest possible opportunity. Documentation should be ongoing in the patient’s chart. Signatures on a consent form should also be obtained at the earliest opportunity. However, completed forms that are more than three or four weeks old might be re-initialed by the patient prior to the procedure to ensure the patient has no further questions.

Q  Do I need a witness to sign the consent form?
A In most every situation and jurisdiction, there is no legal requirement or necessity to have a witness involved in the signing of a consent form. Witnesses are used primarily to testify that the signature on the form was indeed the patient’s. Frankly, in this day of expert handwriting analysis, very few patients ever allege that the signature is not theirs.

Witnesses can be valuable, however, if the legal competency of the patient is called into question such as with very sick, elderly or mentally disabled patients who may not fully understand the nature and scope of what they are signing. In most situations, it is a good idea to have a member of the patient’s family present during the consent process (with the patient’s permission of course).

Q  What do I do if a patient doesn’t want to know about the risks, benefits and alternatives, but wants the procedure done anyway?
A  Make a complete notation to this effect in the medical record and send a letter to the patient confirming your mutual understanding. Do not force the patient to sign the form merely to comply with hospital policy. Work out an alternative procedure with your hospital’s risk manager if the institution requires a consent form before permitting the O.R. to be used.

Q  How should I handle patients who refuse procedures or diagnostic tests that I believe are critically important to the patient’s life or well-being?
A  There is an emerging medicolegal doctrine called “informed refusal” which would require a physician to disclose to the patient the possible risks of refusing needed care. This doctrine generally is not applicable for most elective procedures and could well be interpreted as harassment if used every time a patient disagreed with a physician’s recommendation. But when certain clinical situations would otherwise indicate that the patient may be exposing himself or herself to significant harm, the patient’s refusal to have the test or procedure should be thoroughly noted in the chart. Some providers use a form requiring the patient’s signature, but physicians should be alert as to whether the use of such a form would be more antagonistic than helpful.