Time Sensitive Conditions and Errors in Diagnosis

Paul Weber, JD, OMIC Vice President of Risk Management/Legal

Digest, Spring 2013

Claims related to error in diagnosis continue to challenge OMIC and other medical professional liability carriers. “Diagnostic error” is broadly defined as a diagnosis that is missed, incorrect, or delayed as detected by a subsequent definitive test or finding. Recently, researchers at Johns Hopkins University reviewed 25 years of malpractice claims reported to the National Practitioner Data Bank between 1986 and 2010. [1] Their research revealed that “… among malpractice claims, diagnostic errors are the most frequent, most severe, and most costly of all medical mistakes.” Although diagnostic error cases account for only 13% of OMIC closed claims, they are the most costly, resulting in over one-third of the indemnity paid to plaintiffs.

Managing the risk related to diagnostic error claims involves analyzing both system-related factors (patient-to-physician communication and communication among physician and other health care providers) and cognitive factors (physician did not gather relevant data optimally or failed to synthesize data correctly).

Time is of the essence

OMIC has noticed a subset of “time sensitive” diagnostic error cases in which there was a relatively brief period of time between when the patient was examined and when medical/surgical intervention or referral needed to occur. Many of these OMIC cases included both system-related and cognitive factors that contributed to the error in diagnosis. OMIC closed six such cases in 2012 (ROP, trauma, stroke, aggressive glaucoma, retinal detachment, and endophthalmitis), which accounted for 40% of the $10 million indemnity paid out last year. With the exception of the ROP case, there was an average of only five days between the first patient contact and the correct diagnosis, indicating that clinicians had a brief window in which to make a correct diagnosis before the patient suffered significant problems. A stroke case that settled for $500,000 is a particularly good example of a time sensitive case in which both system-related factors and cognitive factors combined to lead to a diagnostic error and large indemnity payment.

An accident waiting to happen

On March 14, a 53-year-old male patient presented to the insured with complaints of seven or eight episodes of right eye visual acuity loss over the past month. He was not an established patient, and it was unclear whether he was referred by his primary care provider (PCP) as the insured believed, or self-referred as the patient later claimed. The patient reported episodes when his vision became very gray except for a small area at the top. These episodes usually occurred when bending over or straining, lasted four to five minutes, and were sometimes followed by a slight pain in the right eye. The eye exam was essentially normal except for a posterior, subcapsular, polar senile cataract. The patient was noted to be in good general health and oriented to person, place, and time. Since these episodes occurred when the patient bent his neck or strained, the insured believed these actions caused plaques to break off and float to the ophthalmic artery or caused vascular compression. The insured’s diagnosis was transient arterial occlusion of the retina. He instructed the patient to be seen by the referring PCP within two weeks for a workup of transient ischemic attacks (TIA). The patient was told that the PCP would most likely order a carotid ultrasound, and he was advised to “phone immediately for increased pain, increased redness, or decreased vision.” Customarily, the insured’s office would have made the patient’s appointment with the PCP but did not in this case for reasons that are unclear.

The insured sent a letter to the PCP regarding his examination and discharge instructions. The letter stated that the patient had been having amaurosis fugax episodes in the right eye for a few weeks. The PCP later testified that she never received the insured’s letter and, unbeknownst to the insured, the patient had not been seen by this PCP for over four years and was not considered a “current patient.”

A few days after being seen by the insured, the patient had another episode of transient vision loss but did not seek medical attention. One week later, on March 21, the patient collapsed at work. He was taken by ambulance to a large medical center presenting with slurred speech and left-sided weakness. A CT scan of the brain taken in the ER showed a hyper-dense clot in the right cerebral artery, consistent with acute occlusion. There was no evidence of hemorrhage. A bilateral carotid Doppler performed on the same day showed near total occlusion of the right internal carotid artery and 50–60% lesion on the left internal carotid artery. The patient had a cerebral vascular accident (CVA) due to a cerebral clot.

After discharge and rehabilitation, the patient had minor left upper extremity dexterity problems and transient issues with executive cognitive functioning. He filed a lawsuit against the insured, alleging that given the number of episodes of amaurosis fugax, the insured should have referred him for an appropriate workup by a neurologist within 24 to 48 hours. The venue of the lawsuit was “plaintiff friendly” and the jury verdict range was estimated between $1 million and $2.5 million.

OMIC retained three different neuro-ophthalmologists to review the case. One of these experts wanted to be supportive but felt the history taken was a “little lean.” He also stated that “common sense” and “intuition” should have given the insured a sense of urgency regarding the seven or eight events in a one month period. Another expert stated that the insured too quickly ruled out “transient visual obscuration” from the differential diagnosis and that the insured’s theory of “plaque breaking off” and flowing through the carotid artery was a powerful argument for immediate care. The third neuro-ophthalmologist, who testified for the insured, stated that a work-up for amaurosis fugax is not “urgent” or “emergent” when several episodes have occurred over the course of a month or so and are not accompanied by other, more worrisome symptoms. All three experts agreed that had a Doppler ultrasound been ordered quickly, it would have identified the source of the clot at the base of the carotid artery and a surgical correction would have prevented the CVA.

Since the insured was a general ophthalmologist, OMIC also had a general ophthalmologist review the case. She opined that there should have been an urgent (same day) referral to the PCP. She felt strongly that if the PCP could not or would not see the patient, the patient should have been referred to the ER for emergent evaluation, including a neurology consult.

A non-binding hearing was conducted and found that the insured breached the standard of care by not referring the patient to the PCP on a more urgent basis within 24 to 48 hours. However, the hearing panel determined that the plaintiff was more at fault than the insured for not acting sooner to take care of himself, i.e., not making the appointment with the PCP. Also, the panel felt that the patient could have had the stroke at any time, including during the insured’s examination or immediately after he left his office, and that it was speculative whether the stroke could have been avoided. Given the hearing panel’s decision on the standard of care, the consensus of defense counsel, OMIC’s claims department, and the insured was that it was too risky to go to trial and the matter was settled with a $500,000 indemnity payment to the plaintiff.

System-related factors

A “perfect storm” of missed opportunities contributed to the delay in diagnosing the cerebral clot. First, the insured and his staff had different understandings about whether the patient was referred by his PCP or self-referred. The insured erroneously believed that the PCP had referred the patient and, therefore, knew about the episodes of vision loss. The insured also said it was highly unusual for his staff to field a call of vision loss and not make an appointment on a more urgent basis, although there were no written office policies or telephone guidelines for handling appointments.

Had the insured checked the OMIC website, he would have found comprehensive written telephone policies and procedures that would have provided his staff with a checklist to help them gather the necessary information from the patient and determine the appropriate appointment category: emergent, urgent, or routine. Checklists become especially important with time sensitive conditions such as neuro-ophthalmic problems. To this insured’s credit, he made several changes in his appointment practice protocol as a result of this case, including a daily review of all referrals and accompanying paperwork to verify that appointments are scheduled appropriately.

Another system-related issue that frequently impacts time-sensitive conditions is poor communication between provider and patient regarding the nature and urgency of the patient’s condition. The patient in this case claimed not to understand the importance of the follow-up appointment with the PCP and testified that he thought someone would call him with a date for the carotid ultrasound. Even though the hearing panel believed the insured had communicated the urgency of the problem and the patient was primarily responsible for not following up more quickly with his PCP, the case would have been more defensible had the office actually made the referral appointment for the patient. If they had, they would have learned that the PCP was not currently treating the patient, which might have led the ophthalmologist to treat this patient as more high risk. At a minimum, the practice should have given the patient a form specifically indicating the urgency of the appointment.

As noted here and in the Closed Claim Study regarding pseudotumor cerebri, some patients are not fully engaged in the process of their own care. Many ophthalmic practices do a good job of educating and empowering their patients on certain procedures and risks. The American Academy of Ophthalmology patient education brochure “Floaters and Flashes—A Closer Look” is an example of ophthalmologists educating patients to seek timely follow-up care and medical advice and to become active participants in their own care and diagnostic process.

Cognitive factors

In the past few years, the research and literature on diagnostic error have grown significantly. In 2007, Boston hematologist-oncologist Jerome Groopman vividly described in his bestseller “How Doctors Think” how thought processes underlie many diagnostic errors. Cognitive psychologists and researchers who have analyzed diagnostic error believe physicians use a “dual process” to arrive at a diagnosis using both “System 1,” an intuitive/subconscious process, and “System 2,” a systematic, analytical process. When using System 1, physicians employ mental shortcuts (heuristics) to reach decisions that are right the majority of the time. The insured in the stroke case later acknowledged several cognitive processing errors, biases, and limitations linked to System 1 shortcuts.

First, the patient’s general good health alleviated concern about the amaurosis fugax being urgent or emergent. The insured saw the patient in the context of an otherwise healthy 53-year-old man. This is an example of “context error,” which can occur when the diagnosing physician is biased by patient history, previous diagnosis, or other factors and thus formulates the case in the wrong context.

Second, the fact that the patient’s symptoms occurred mostly when he was bending over caused the insured to give too much weight to a diagnosis of transient arterial occlusion. The neuro-ophthalmology experts pointed out that the insured’s own patient history was incomplete and he did not develop a differential diagnosis, too quickly coming to the conclusion of transient arterial occlusion. This is an example of “premature closure.” The insured narrowed his choice of diagnostic possibilities (i.e., hypotheses) too early in the diagnostic process, such that the correct diagnosis was minimized or not considered.

Finally, the insured himself felt the biggest lesson he had learned was to consider the most serious potential diagnosis and let it drive the plan. To improve his understanding of neuro-ophthalmic risk, the insured participated in several CME courses related to transient visual loss and diagnosis and management of neuro-ophthalmic emergencies.

In order to reduce System 1 (intuitive) cognitive processing errors and related biases, some experts suggest a checklist. A copy of several sample checklists can be found at https://orlando.isabelhealthcare.com/pdf/EducationStrategiesToReduce DiagnosticError.pdf.

Checklists are simply a reminder to perform a conscious, reflective review to optimize clinical decision making and provide corrective oversight to the automatic processing that underlies diagnostic errors such as the one demonstrated in the stroke case.

Error in diagnosis is a challenge facing all of medicine. Multiple factors, system-related and cognitive, are involved. OMIC believes that only with sustained research to better understand these multiple factors will interventions be developed to reduce errors that cause injury to patients and result in claims against physicians and other health care providers.

1. Saber, Tehrani AS, Lee HW, et al. “Quality and Safety in Health Care.” First published online April 22, 2013 as doi: 10.1136/bmjqs-2012-001550.

Improper Disposal of Medical Records

Natalie Kelly, NAS Insurance Services/Lloyds Associate Vice President of Claims 

Allegation 

Violation of Health Care Privacy and Security Rules.

Disposition

Settled without fines or penalties. Legal and patient notification costs totaled $85,000.

Case summary 

Employees of a physician disposed of medical records inappropriately by placing them into office recycling bins. Although the contents of the recycling bins were supposed to be shredded, these instructions were not communicated to the building’s janitorial services. As a result, the files were transferred to the building’s recycling area without being shredded. Although only approximately 500 patients were involved in the breach, the physician could not be sure which files had been placed in the recycling bins and which had not. Therefore, all of the physician’s 7,500 current and past patients had to be notified of the breach. The physician was also required to notify the Department of Health and Human Services (HHS), which responded by opening an investigation and requiring the physician to implement a program to comply with Privacy and Security Rules. Once its investigation had been completed, HHS dismissed the matter without assessing fines or penalties against the physician.

Analysis

The insured’s responsibility to safeguard patients’ protected health information was not met. Failure to adequately supervise the destruction of the records created a scenario that could have resulted in a significant fine under HIPAA Privacy or other regulations. Although no fine or penalty was imposed, there were significant legal and patient notification costs related to compliance with privacy laws, and the insured’s staff were forced to deal with unwanted distractions that took time away from their normal duties.

Risk management principles 

Protecting patients’ health information should be given a high priority to avoid violations of HIPAA, HITECH, and other health information regulations. Avoid outsourcing or delegating the destruction of files or records to others unless you or your staff members are present to supervise the shredding of files or the destruction of data storage devices. OMIC’s professional liability policy includes coverage for this type of event. Under the Broad Regulatory Protection and eMD Cyber Liability benefits, there is a $50,000 limit to pay for legal and patient notification costs related to alleged HIPAA Privacy and other regulatory and data breach violations. See Policy Issues for more information. Learn about the 14 Additional Benefits in your OMIC policy that will protect you from these (and related) types of exposures.

Breach Notification: How OMIC Can Help You

Kimberly Wynkoop, OMIC Legal Counsel

Digest, V23 N3 2013

As explained in the lead article (HIPAA Omnibus Final Rule What To Do), HIPAA requires that covered entities (“CEs”) notify individuals whose unsecured protected health information (“PHI”) has been impermissibly accessed, acquired, used, or disclosed, compromising the security or privacy of the PHI. Such notice must be given unless the CE can show there is a “low probability” that PHI has actually been compromised. If notification is required, HIPAA sets forth the manner and timing for doing so. This process can be daunting and expensive. To assist our insureds, OMIC’s policy includes an additional benefit: Security and Privacy Breach Response Costs, Notification Expense, and Support and Credit Monitoring Expense Coverage. This article will explain ophthalmologists’ breach response and notification responsibilities and the assistance OMIC’s benefit provides.

Notice to individuals

The CE should have a standard breach notification letter written in plain language that includes all of the HIPAA required elements (see OMIC’s sample at http://www.omic.com/hipaahitech-resources/). The CE must modify this letter and send it out to all affected individuals. This letter should be sent by first-class mail to the last known address of the individual or, if the individual has agreed to electronic notice, by email. If there is insufficient or out-of-date contact information that precludes mail or email notice, a substitute form of notice must be provided. For fewer than 10 individuals, the substitute notice may be provided by an alternative form of written notice, by telephone, or by other means. For 10 or more individuals, the substitute notice must be in the form of either a conspicuous posting for 90 days on the CE’s website, or a conspicuous notice in major print or broadcast media where the affected individuals likely reside. The notice must include a toll-free number that remains active for at least 90 days where an individual can learn whether his or her PHI was included in the breach. Notice to affected individuals must be made without unreasonable delay and in no case later than 60 calendar days after the discovery of the breach. If the CE determines that notification requires urgency because of possible imminent misuse of unsecured PHI, notification may be provided by telephone or other means, as appropriate, in addition to the methods outlined above. It is the responsibility of the CE to demonstrate that all notifications were made as required, including evidence demonstrating the necessity of any delay.

Notice to HHS

In the event a breach of unsecured PHI affects 500 or more individuals, HHS must be notified at the same time notice is made to the affected individuals, in the matter specified on the HHS website. If fewer than 500 of the CE’s patients are affected, the CE must maintain a log of the breaches to be submitted annually to the Secretary of HHS no later than 60 days after the end of each calendar year.

Notice to the media

In the event the breach affects more than 500 residents of a state, prominent media outlets serving the state and regional area must be notified without unreasonable delay and in no case later than 60 calendar days after the discovery of the breach. The notice must be provided in the form of a press release. If a law enforcement official states to the CE that notice would impede a criminal investigation or cause damage to national security, the CE must delay the notice for the time period specified by the official in writing, or, if not in writing, no longer than 30 days from the date of the oral statement. This applies to notices made to individuals, the media, and HHS.

OMIC’s coverage

In response to a security or privacy breach, OMIC will pay for the employment of a public relations consultant to avert damage to the reputation of an insured resulting from an unexpected report about the breach through any media channel if that report threatens to damage an insured’s reputation. OMIC will also pay the expense to comply with governmental privacy legislation mandating notification to affected individuals, including legal expenses, computer forensic fees, public relations expenses, postage expenses, and related advertising expenses. OMIC also pays the expenses for the provision of customer support in the event of a privacy breach, including credit file monitoring services and identity theft assistance for up to 12 months. OMIC must give prior written consent for any of these expenses to be paid. The maximum amount OMIC will pay is $50,000. If you have questions about these policy benefits, please call OMIC’s Underwriting Department at 800.562.6642, ext. 639. If you need to take advantage of this benefit, contact OMIC’s Claims Department at ext. 629.

Breach Letter: Required Components

• A brief description of what happened, including the date of the breach and the date of the discovery of the breach, if known.

• A description of the types of unsecured PHI that were involved in the breach (e.g. full name, SSN, DOB, address, account number, diagnosis).

• Any steps the individuals should take to protect themselves from potential harm resulting from the breach.

• A brief description of what the CE is doing to investigate the breach, to mitigate harm to individuals, and to protect against further breaches.

• Contact procedures for affected individuals, including a toll-free number, email address, website, or postal address.

Additional Benefits: Broad Regulatory and e-MD Protection

Kimberly Wynkoop, OMIC Legal Counsel

Digest, Spring 2013

OMIC is pleased to announce that the Broad Regulatory Protection and e-MD Protection coverages provided in OMIC’s Professional and Limited Office Premises Liability Insurance policy have been enhanced for 2013 at no additional charge. This article is a summary; for a complete review of your coverage, please refer to the OMIC policy.

Peer review coverage

OMIC’s Broad Regulatory Protection (BRP) reimburses insureds for legal expenses relating to regulatory proceedings, which include billing errors, DEA, EMTALA, HIPAA, covered licensing, and STARK proceedings. BRP also covers fines or penalties related to billing errors, EMTALA, HIPAA, and STARK proceedings. While OMIC’s policy already covered actions by regulatory agencies and state licensing authorities under its Disciplinary Proceeding Protection and BRP, in 2013, it added peer review bodies to the list. Under BRP, OMIC now reimburses legal expenses for professional review actions by the review body of a hospital or other health care facility that could adversely affect the insured’s clinical privileges there.

e-MD additions

As insureds continue to move more of their records, communications, and marketing online, coverage for cyber liability risks becomes more crucial. OMIC’s e-MD Protection now provides seven different coverages. One of the 2013 additions is Multimedia Liability Coverage. It covers claims made against the insured for the display of any electronic or print media by the insured that directly results in defamation, invasion of privacy, plagiarism, or copyright infringement.

Another new coverage is Network Asset Protection. It covers digital assets loss, that is, the expenses necessary to restore or replace the insured’s damaged or stolen data and computer programs, because of accidental damage, operational mistakes, or a computer crime that an insured failed to prevent. It also covers the insured’s income loss and interruption expenses incurred during the time it takes to restore these digital assets.

e-MD Protection now also includes Cyber Extortion and Cyber Terrorism Coverages. Under Cyber Extortion Coverage, OMIC pays money to stop the person responsible from executing a credible threat to release confidential information or corrupt the insured’s computer system. Cyber Terrorism Coverage pays income loss and interruption expenses during a period of restoration of the insured’s computer system required because of an act of terrorism.

e-MD enhancements

While the following provisions are not new, they have been enhanced. The e-MD Security and Privacy Liability Coverage covers claims made against the insured for security and privacy wrongful acts. The Security and Privacy Regulatory Defense and Penalties Coverage covers legal expenses and regulatory fines, penalties, or compensatory awards the insured must pay because of such acts. Many acts fall within the definition of security and privacy wrongful acts. For example, a security and privacy wrongful act occurs if an insured fails to prevent unauthorized access to or infection of the insured’s computer system (a “security breach”) that results in destruction of electronic data stored on the insured’s computer system, unauthorized disclosure of confidential information that is in the insured’s care, or unauthorized access to a computer system other than the insured’s. The insured’s failure to prevent the transmission of computer viruses from the insured’s to a third party’s computer system is also a security and privacy wrongful act. A privacy breach, i.e., a breach of confidence, a violation of rights to privacy, or a violation of laws associated with the control of personally identifiable financial or medical information, also constitutes a security and privacy wrongful act.

The Security and Privacy Breach Response Costs, Notification Expense, and Support and Credit Monitoring Expense Coverage now covers the cost of employing a public relations consultant to mitigate damage to the insured’s reputation due to a publicized report of a privacy or security breach. It also covers the expenses of notifying affected individuals in the event of such a breach. Finally, it pays for the provision of customer support in the event of a privacy breach, including credit file monitoring and identity theft assistance.

The BRP and e-MD per proceeding/claim and aggregate limit is $50,000. The BRP and e-MD Protection coverages also include a two year extended reporting period if the insured acquires tail coverage for the policy. If you have questions about these policy benefits, please call 800.562.6642, ext. 661. If you need to report a proceeding or claim, contact OMIC’s Claims Department at 800.562.6642, ext. 672.

Abandonment or Noncompliance?

Ryan Bucsi, OMIC Senior Litigation Analyst

Allegation

Failure to follow up with patient after a negligent injection of Kenalog.

Disposition

Defense verdict.

Case summary

A 56-year-old male patient with type II diabetes began to complain of decreased vision OD one month following uncomplicated cataract surgery OD. He was referred to an OMIC-insured retinal specialist, who diagnosed diabetic macular edema and proliferative diabetic retinopathy OD. The insured recommended an intravitreal injection of preservative-free triamcinolone acetate (Kenalog), which was performed without complication. The following day, the patient returned to the retinal specialist with hand motion vision, pain, pressure, and photophobia. The insured diagnosed pseudoendophthalmitis and prescribed antibiotics. Three days later, the patient returned to the insured with hand motion vision. The insured diagnosed pseudo versus infectious endophthalmitis and the patient elected to continue with antibiotics and steroid drops versus injection. Ten days later, the patient’s visual acuity improved to 20/100 OD; however, two weeks later, the patient called to report pain and redness OD. The insured asked the patient to come into a satellite office, but the patient declined due to the increased driving distance. The patient was advised of the risk of not being seen and an appointment was scheduled for two days later. On the following day, the patient telephoned the retinal specialist to report pain and increased blurring. The patient was advised to come into the satellite office, but once again refused citing the increased distance. When the patient finally did return to the office, visual acuity was hand motion OD and intraocular pressure was 66. The insured tapped the right eye on two occasions, which only temporarily decreased the pressure. When the patient declined a third tap, the insured referred the patient for a trabeculectomy, but this was delayed as the patient was admitted to the hospital for dehydration. Following this hospitalization, a trabeculectomy was performed which eventually resolved the increased pressure. A second retinal consultation by a non-OMIC insured was performed, which revealed hand motion vision, no detachment, vitreous opacity, and controlled pressure OD. A pars plana vitrectomy and lens removal were eventually performed which resolved the endophthalmitis, but the vision remained at hand motion.

Analysis

Plaintiff alleged that the Kenalog injection caused glaucoma and endophthalmitis resulting in hand motion vision OD. He also alleged that he was not aware of the off-label use of Kenalog and that the insured “abandoned” him. Plaintiff’s expert testified that the insured had a duty to travel to see the patient. The defense argued that the insured met the standard of care for informed consent by advising the patient of the risks and alternatives and that the patient signed a consent form for the Kenalog injection. The defense refuted the abandonment allegation and argued contributory negligence by the patient when he declined to drive to a satellite office, even though it was no more than 27 additional miles from where he was regularly seen. The defense expert testified at trial that the patient’s noncompliance played a definite role in his outcome. The defense also noted that post-injection, steroid-induced glaucoma and endophthalmitis are known side effects of intravitreal Kenalog injections. Although the discussion about the off-label use of Kenalog was not documented in the patient’s chart, during deposition the office technician explained that the insured “always” explained to patients when drugs were used off-label. The plaintiff demanded $750,000 to settle, but the insured and OMIC agreed that the case was defensible. After a three-day trial and 90 minutes of deliberation, the jury returned with a defense verdict.

Risk management principles

To prove abandonment, the plaintiff must show that there was an established physician-patient relationship and that care was withdrawn without adequate warning. OMIC is not aware of any legal duty during this relationship for a physician to go to a patient’s home, nursing home, or, as in this case, another office. Patients have a legal right to refuse care. On the other hand, physicians have a legal duty to explain the consequences of refused care, which the insured did. OMIC recommends that physicians inform patients of off-label use, especially if the treatment consists primarily of an off-label medication, as in this case (see sample consent form at http://www.omic.com/informed-consent-for-off-label-use-of-a-drug-or-device/).