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.

Pseudotumor Cerebri in Young Female

Ryan Bucsi, OMIC Senior Litigation Analyst

Case summary

A 23-year-old female presented to the emergency room with blurred vision and was advised to see the OMIC-insured ophthalmologist the following day for examination. She did not keep the appointment, but five days later called the insured’s office to complain of decreased vision and was advised to come in. On initial examination, the patient’s visual acuity was 20/125 OD and 20/50 OS. The pupils were reactive with trace evidence of an afferent papillary defect. A visual field test was not performed. The OMIC insured’s diagnosis was significant bilateral papilledema likely secondary to pseudotumor. Based on the patient’s size (4’11” and 150 pounds), the insured prescribed 1000 mg of Diamox to be taken daily. He also referred the patient to a neurologist for a lumbar puncture. Upon the advice of the neurologist, the patient did not start the Diamox until after the lumbar puncture. The ophthalmologist advised the patient that the pressure was 36 (normal <25) and instructed her to start the Diamox. Approximately three weeks later, the patient returned to the OMIC insured and his partner, another OMIC-insured ophthalmologist, for an examination. Visual acuity was count fingers OU. A positive finding of afferent papillary defect OD was again noted. A constricted visual field based on a confrontational field test revealed a significantly limited visual field OU. The patient was diagnosed with pseudotumor cerebri and Diamox was increased to 1500 mg daily. The OMIC insureds documented that if no improvement was seen in the next week, the patient would be referred to a neuro-ophthalmologist. The patient did not return to the OMIC insureds after this visit. She self-referred to another ophthalmologist, who referred her on to a neuro-ophthalmologist. The neuro-ophthalmologist suspected that the patient had asymptomatic but uncontrolled bilateral disc edema for much longer than six weeks and that for unclear reasons it went into an accelerated phase resulting in significant loss of vision. The patient underwent two bilateral optic nerve sheath fenestrations, but final visual acuity was hand motion at 1.5 feet OD and 6/200 OS.

Analysis

Plaintiff’s experts opined that both OMIC insureds failed to appropriately diagnose and manage the patient’s pseudotumor cerebri and violated the standard of care by failing to refer the patient to a neuro-ophthalmologist for evaluation of pseudotumor cerebri. Several experts were retained by OMIC to review this case and some common opinions emerged. First, all of the defense experts were concerned that a visual field test was not done during the patient’s initial examination by the insureds. They felt a visual field test was warranted in order to determine the degree of central vision loss. The patient could not see the left part of the visual acuity chart so the experts felt that the extent of the patient’s disease was quite evident during the initial examination. Most of the defense experts opined that upon initial presentation, the patient’s condition was an ophthalmic emergency and “cried out for an immediate referral” to a neuro-ophthalmologist. The two OMIC insureds themselves were not entirely confident in the care they provided to the patient and expressed concern that any neuro-ophthalmologist called to testify would be critical of their care and treatment. As a result of the opinions of our retained experts and the OMIC insureds, the case was settled at mediation on behalf of the two OMIC insureds and their insured corporation for $850,000.

Risk management principles

The insureds made the correct diagnosis in this case but, sadly, delayed aggressive treatment of the pseudotumor cerebri as they did not appreciate that it was an emergency situation. Not only did this patient have a high-risk condition, but her behavior in delaying follow-up treatment for five days after her ER visit made her a high-risk patient. Patients who risk serious vision loss and do not take their condition seriously should be referred early for subspecialist care. Early referral ensures that patients likely to delay care or not follow treatment recommendations receive the most advanced care from the start.

Abandonment or Noncompliance?

Ryan Bucsi, OMIC Senior Litigation Analyst

Digest, Winter 2013

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/).

Responding to a HIPAA Privacy Violation Alleging Improper Disposal of Records

Natalie Kelly, NAS Insurance Services/Lloyds Associate VP Claims

Allegation

Violation of Health Care Privacy and Security Rules.

Disposition

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

Case Summary

The 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 (“DHHS”). The DHHS responded by opening an investigation, and requiring the physician to implement a program to comply with Privacy and Security Rules. Once their investigation had been completed, the DHHS dismissed the matter without assessing fines or penalties against the physician.

Analysis

The insured’s responsibility to safeguard patient’s 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 a fine or penalty was not imposed in this case, there were significant legal and patient notification costs related to compliance with privacy laws and unwanted distractions that staff were forced to deal with, taking 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 this related BRP/eMD Coverage Q&A for more information.

This is OMIC web exclusive content.

Co-Defendant CRNA Denies Responsibility for Failed Resuscitation

OMIC ARTICLES ON ANESTHESIA LIABILITY

• This article appeared in an issue of our Digest devoted to wrongful death claims. The policy article in that issue addresses supervision of CRNAs and liability questions: https://docs.google.com/viewerng/viewer?url=http://www.omic.com/wp-content/uploads/2012/12/Digest-Summer-2012.pdf
• Another issue of the Digest analyzed ophthalmic anesthesia claims: https://docs.google.com/viewerng/viewer?url=http://www.omic.com/wp-content/uploads/2012/12/Digest-Winter-2006.pdf.
• Here are detailed risk management recommendations on ophthalmic anesthesia: http://www.omic.com/wp-content/uploads/2012/04/Anesthesia-Liability.pdf.

Ryan Bucsi, OMIC Senior Litigation Analyst 

Digest, Summer 2012

Allegation

Negligent resuscitation resulting in death of 45-year-old father of three.

Disposition

Case settled for $1,775,000 of which CRNA contributed $975,000 and OMIC insured contributed $800,000.

Case Summary

Anon-OMIC-insured ophthalmologist performed cataract surgery on a patient who subsequently developed a hemorrhage OD. The patient was then seen by the insured, who had previously treated his proliferative diabetic retinopathy and bilateral retinal detachments. The insured recommended a vitrectomy under local anesthesia at a surgery center knowing that the patient had tolerated the cataract surgery under local anesthesia. During the vitrectomy, a CRNA administered local anesthesia with IV sedation, and the insured performed a retrobulbar block OD. When the patient became agitated and complained of pain, the CRNA provided more sedation after which the patient turned pale and stopped breathing. The CRNA administered oxygen through an Ambubag but O2 saturation did not increase. The insured instructed the CRNA to intubate and 911 was called. Despite intubation, the patient’s O2 saturation did not improve. The CRNA confirmed that the tube was in the trachea but asked the surgeon to listen for breath sounds with him; both the surgeon and CRNA heard breath sounds. When the paramedics arrived, they determined that the CO2 monitor had not changed color indicating the tube was in the esophagus rather than the trachea. This prompted the CRNA to get into a shoving match with one of the paramedics. The paramedic re-intubated the patient and O2 saturations began to go up. The patient was transferred to the hospital where he died eight days later.

Analysis

The plaintiff’s anesthesiology expert had many criticisms of the insured ophthalmologist. He testified that surgery should not have been performed since the plaintiff had low blood sugar and high blood pressure on the morning of surgery. It was this expert’s opinion that, given the patient’s medical condition, general anesthesia should have been used, but if local anesthesia was used, the surgery should have been performed in a hospital or facility where an MD anesthesiologist was available. Since this surgery center did not have an MD anesthesiologist, the expert pointed to the ophthalmologist as the “captain of the ship.” The expert testified that the CRNA did not intubate the patient properly and the insured did not diagnose improper esophageal intubation.

The defense expert disagreed with these opinions and the role of a surgeon in anesthesia care. He insisted that the anesthesia provider is responsible for monitoring the patient during surgery. He testified that the CRNA failed to monitor and communicate a low oxygen level to the insured prior to the patient’s arrest, thus leading to a delay in resuscitation. Unfortunately, the defense expert was not comfortable rendering an opinion on the standard of care related to the decision to perform surgery. The co-defendant CRNA testified at his deposition that he was responsible for providing anesthesia to the patient, but that the insured was the “captain of the ship.” The CRNA admitted that he had not performed an intubation in the five years preceding this case and that he never discussed the risks and complications of anesthesia with the patient because he did not want to scare him. However, he maintained that the intubation was properly done and that the paramedic dislodged the tube. It was defense counsel’s opinion that a jury would award the plaintiff $2.8 to $4 million and hold the OMIC insured 25% to 50% liable. The CRNA settled first for $975,000, and the OMIC insured settled later at mediation for $800,000.

Risk Management Principles

For the OMIC insured, this could be viewed as a case of being in the wrong place at the wrong time. The procedure was performed in a surgery center with a CRNA who allegedly did not properly intubate the patient leading to a prolonged period without oxygen and eventual death. There are several steps insureds can take to minimize the risk of an improper resuscitation in a surgery center. First, find out if there is a peer review process in place to review the competency of CRNAs and anesthesiologists. Inquire about the emergency response measures in place and whether there is anyone else available within the surgery center to assist with resuscitations. Lastly, call 911 immediately when a potentially life-threatening situation arises.