Legal Review & Commentary: Dialysis mistakes leads to wrongful death and a seven-figure settlement

By Jonathan D. Rubin, Esq. Partner Kaufman Borgeest & Ryan New York, NY

Christopher U. Warren, Esq. Associate Kaufman Borgeest & Ryan Parsippany, NJ

Leilani Kicklighter, RN, ARM, MBA, CHSP, CPHRM, LHRM The Kicklighter Group Tamarac, FL

News: The five children of a 65-year old woman settled a wrongful death suit against a dialysis clinic. The children alleged that the clinic made many mistakes while treating their mother, and they claimed that those mistakes caused her death. The dialysis clinic agreed to pay the children a seven-figure amount to settle their claims against it, but did not admit wrongdoing. The children accepted.

Background: The 65-year old mother of five was suffering from congestive heart failure (CHF) and kidney failure. She was living in a nursing home for about a year, but her five adult children wanted to care for her themselves. As such, the children made arrangements for outpatient dialysis treatment with the clinic, and they moved their mother back into the family home.

The mother required dialysis treatments three days a week. During her first week home, she presented to the clinic for her first two treatments without incident. However, about three hours into her third treatment, a staff person at the dialysis clinic called the children and said that the clinic was rushing their mother to the hospital. The clinic would not tell the children why. The doctor at the hospital told the children that something went wrong with their mother’s dialysis treatment at the clinic. Two days later, the doctor said that there was nothing he could do to save their mother. The children decided to take her off life support, and she died a few days later.

The children claimed that after the incident, they attempted to contact the clinic numerous times to determine what happened during their mother’s third dialysis treatment. The children said that the clinic never responded to their inquiries. As a result, the children filed a lawsuit against the clinic and its employees.

The children alleged that the clinic made several “major” mistakes during the dialysis treatment and these mistakes caused their mother’s death. The children specifically alleged that an unqualified patient care technician did a reversal of the mother’s dialysis lines and failed to secure them properly. They claimed this action caused their mother to start hemorrhaging. Additionally, they alleged that machine alarms went off but were ignored, which pushed their mother into critical condition.

The clinic would not comment on its treatment of the mother and cited privacy concerns. It offered the children a seven-figure settlement to resolve their claims against it, but did not admit wrongdoing. (The specific settlement amount remains confidential, but it was confirmed to be seven figures.) The children accepted this settlement.

What this means to you: This unfortunate outcome involves a patient who suffered from CHF in addition to the kidney failure; those co-morbidities made this patient a higher risk. Renal failure can result in fluid retention and that, in turn, has an influence on CHF, so both need to be carefully monitored. She had been living in a nursing home for about a year; her CHF was controlled, and her routine hemodialysis treatments three times a week were uneventful. From the information we are given here, we can presume the dialysis clinic the patient’s children identified through their research was not one operated by the same company used by the nursing home, as her care was not transferred to a different clinic within the same organization.

We don’t know if this 65-year-old was a candidate for kidney transplant or the underlying reason for her kidney failure. We do know she was living a positive quality of life at home with her children for less than one week before this tragic event.

Additional background information related to this event included a visit by surveyors from the Centers for Medicare and Medicaid Services (CMS) about nine months after this event. What triggered this inspection is unknown. However, the report (a public record) of this inspection reflects, among other things, that staff members were not following infection prevention procedures as observed by not changing gloves or washing hands or alcohol cleansing between patients, and by not using equipment and supplies on one patient only, i.e., tape, scissors, etc. Other observations noted were that patients were not always receiving dialysis for the ordered time, and there was no documentation regarding why the time was cut short. The second amended complaint alleged that the oxygen tank at the time of this event was empty. All of these areas raise concerns from the viewpoint of risk management and quality of care.

While this unfortunate event occurred in a freestanding dialysis center, the issues would apply to any dialysis setting regardless of ownership. The scenario crosses many domains within an organization. For example, here we have a patient care technician (employee) who stepped outside his job description and qualifications to manipulate the patient’s dialysis lines, an activity for which he was not qualified. The licensed nurse who is responsible for this activity and also responsible for monitoring the patient allowed this practice or was not closely monitoring the patient assigned. Background information in this case references that this practice had been brought to the attention of the clinic management, and no action had been taken to intervene.

This practice falls into the human capital domain. A policy and procedure should be in place regarding handing of such employee issues on a timely basis. Licensed nurses are responsible for overseeing the care of patients to whom they are assigned and to all patients in general. If an employee is observed carrying out an activity for which he or she is not trained or qualified, it is up to the nurse to intervene and immediately report the event. It is then the responsibility of management, with the input and support of human resources staff, to address the issue that includes counseling or other appropriate action, depending on the issue. Risk management should facilitate this area to be sure this situation is appropriately addressed and corrected.

Immediately, on the day of this event, the dialysis machine and all tubing and other supplies and equipment used by this patient should have been collected, labeled, and sequestered under lock and key in case there was a need to conduct any further studies or evaluation. The chain of evidence should have been maintained under the direction of legal counsel through the facility/organization risk manager.

One of the known human error risks that was the basis for a Sentinel Event Alert from The Joint Commission (TJC) is the mis-connection of medical lines, i.e., intravenous lines (IV), tube feedings, and dialysis, to name a few. Mis-connection of the hemodialysis lines is a known risk and, as such, policies and procedures and education should be addressed with all employees whose role involves handing the lines. Some manufacturers are attempting to address these issues by making square connectors only connect with other square connections or red with red and green with green, for example.

Another Sentinel Event Alert from TJC is failure or slow response to alarms due to alarm fatigue often brought about because of the frequency of alarms. Rather than ignoring an alarm, all alarms should be addressed at the source. Alarm fatigue often causes alarms to be turned down, turned off, or ignored. Any of these activities can result in an untoward outcome such as in this situation in which it is alleged that the alarms were ignored. Sometimes the settings need to be adjusted to prevent alarms from sounding unnecessarily, but in all cases, the reason an alarm is sounding should be addressed and evaluated at its source.

In addition to the moral and ethical correct thing to do, the American Medical Association (AMA), TJC, the Accreditation Association for Ambulatory Health Care (AAAHC), and many states require disclosure of adverse events to patients/families. This adverse event was one such event with which a disclosure discussion should have been coordinated, yet the family had to resort to filing a lawsuit to gain information regarding what happened to their mother while in the dialysis facility for care. The facility risk manager should have facilitated a disclosure meeting with the family. The organization should have a process and access to legal counsel knowledgeable about health law to advise in those instances when an adverse event occurs regarding the disclosure process.

Heartfelt condolences to the family for the event should be extended as well. Lack of communication and anger (often fostered by the lack of communication) are frequently the genesis of many an asserted lawsuit. A disclosure meeting might not prevent a lawsuit, but it might prevent the anger and does start the statute of limitations to roll.

As soon as feasible after such an event as this one, the risk manager should have initiated a root cause analysis (RCA) to be convened to identify why this untoward event happened. Depending on the laws of the state, legal counsel might need to be involved in this process to ensure the attorney-client privilege, but in any case this process is a part of the investigation that should be undertaken while memories are still fresh. In addition, the professional liability insurance carrier of the facility should be made aware of this event, and that carrier’s advice should be heeded as well.

Annually, as part of the evaluation of each employee, his or her job competency should be evaluated as well. We have no information whether this evaluation was a part of this organization’s processes, but it should be for all organizations. It is during this evaluation process that aspects of professional responsibilities and practice boundaries can be discussed and emphasized.

We have nothing to support the allegation that the oxygen tank was empty, but it does raise the issue of daily checking to verify that all emergency equipment is in working order, should it be needed at any time. One such check would include the oxygen level in the active tank and in the backup tanks. Other checks would include the crash cart contents and current expiration dates and availability of drugs in the crash cart. Policies and procedures should govern these activities, and risk management should verify the monitoring checklist to ensure the daily and other periodic checks are being carried out.

This facility needs to re-educate all staff as to their job description and responsibilities, and administrative staff should be monitoring compliance. When non-compliance is identified, immediate steps should be taken to intervene and correct those who are stepping outside their position boundaries.