Davenport dialysis center led the state in violations last year

Last November, an eastern Iowa man was preparing for his usual Saturday morning dialysis treatment when he was called at home and told his appointment was canceled due to a lack of staff at the local clinic.

For patients with failing kidneys, dialysis is a life-saving treatment that filters the blood and removes toxins or excess fluid from the bloodstream. Many patients require three dialysis treatments per week simply to remain alive.

As the man later told state inspectors, the decision by Davenport’s Green Country Dialysis to cancel his appointment on short notice had a significant impact on his health.

“I had to go to the ER on Monday because there was no dialysis on Saturday,” he said. “I could not breathe, I was short of breath – basically because of fluid in the lungs.”

In 2022, state inspectors cited 18 of Iowa’s 69 dialysis centers for violations of some kind. Green Country accounted for 32 of the 125 regulatory violations that were reported by inspectors — 25% of the statewide total.

In addition to leading the state in the number of violations, Green Country was cited three times for placing patients in “immediate jeopardy” – a formal designation that means patients were at a high risk of serious harm.

One of the three incidents was the Nov. 5 shutdown that left patients with nowhere to go for dialysis that day. Some of the affected patients complained to inspectors they were given no option but to call 911 after being told their appointments were canceled.

“I understand that life happens, people get sick, but my concern is, ‘What’s the backup plan?” one patient told inspectors.

He added that he grew so ill that by the time of his next appointment the following Tuesday, he “blacked out” toward the end of the treatment. “I am very concerned about that,” he said, according to inspectors.

The facility’s records back up the man’s claim. State inspectors allege the man’s file at Green Country states that his blood pressure “got low near the end of treatment and he was unresponsive for almost a minute.” Alarms sounded and a nurse administered fluids and stabilized the man before sending him home.

According to the inspectors, a patient care technician at Green Country later acknowledged the clinic had failed to activate its emergency management plan and hadn’t routed patients to other nearby dialysis centers. The facility administrator wasn’t even aware of the situation until four days later, at which point he notified the state, inspectors reported.

Green Country’s medical director told inspectors the shutdown could have had “very bad” consequences for patients, including death. One of the clinic’s patient care technicians told inspectors the facility shouldn’t have closed, saying, “It’s just common sense. Dialysis is a life-saving treatment.”

The Davenport clinic’s administrator, Shannon Holst, did not respond to calls from the Iowa Capital Dispatch. In a written statement, the facility said “the health and safety of our patients is our top priority, and we are committed to ensuring that people living with end stage kidney disease in this community have continued access to high-quality care.”

The statement indicated the facility uses the findings of inspectors “to make improvements and maintain the highest clinical standards within our facility,” and that all of the violations cited last year resulted in a state-approved plan of correction.

“We are proud of our team for their tireless efforts to resolve all outstanding concerns,” the statement said.

Green Country’s 2022 violations

In January, state inspectors revisited Green Country and found it to be in full compliance with all regulations. No violations were cited at that time.

That marked a significant improvement from last year, when inspectors cited the facility for a wide range of deficiencies:

Equipment failure: In June, the “water room” at the facility – a critical component of dialysis treatment used to deliver ultra-clean water to patients – appeared to fail, with alarms sounding while two patients were in the process of receiving dialysis. One patient’s treatment ended 52 minutes early and the other 15 minutes early, with no physician’s order to that effect.

In addition, the clinic was cited for failing to notify a technician that a device used to monitor the water used for dialysis treatments was not operating properly. A biomedical technician on staff told inspectors the device had frequently been inoperable, but the facility’s interim administrator stated there were no issues with it.

In addition, the clinic’s biomedical operations manager reviewed records presented by the inspector and acknowledged it appeared the staff had not been testing equipment for contaminants – a task, he said, that “absolutely must be done.”

Medical procedures: In February, the facility was cited for not adequately disinfecting equipment used to inject patients with intravenous fluids. In addition, facility records indicated a patient who was to have three liters of fluid removed from their body during treatment instead had 4.5 liters removed.

In June, inspectors returned and cited the clinic for failing to adequately protect patients from bacteria and infections. The clinic was also cited for failing to test for the absence of any residual disinfectant in one component of the dialysis equipment before it was used by patients. That particular violation was deemed to be serious enough to have placed patients in immediate jeopardy.

A second immediate-jeopardy violation was cited when inspectors determined the clinic had not properly tested and then sequestered a dialysis machine after a patient using the device went into cardiac arrest. “The egregious effect of this systemic failure” resulted in Green Country’s inability to ensure the safe provision of dialysis for patients, the inspectors reported.

Cleanliness: In February, inspectors watched as patients and staff members violated infection-control protocols such as handwashing when entering treatment areas and handling supplies. The staff also failed to adequately disinfect a dialysis treatment chair for patients, with the inspector noting dried liquid of some kind on the equipment.

Inspectors also observed three patient care technicians who each failed to sanitize other equipment used by patients and the staff. Patient supplies were stored in a staff refrigerator alongside workers’ food and beverages.

Outdated supplies: In February, inspectors found multiple solutions and pieces of equipment that were expired, some for nine months. In June, inspectors returned and found more recently expired supplies.

$950 million in settlements paid out

DaVita, which operates Green Country Dialysis, is one of the nation’s largest providers of dialysis services, with more than 200,000 patients and 3,500 clinics nationwide. Over the years, the company has repeatedly found itself at odds with prosecutors and whistleblowers.

In 2012, DaVita paid $55 million to settle a whistleblower lawsuit alleging the company double-billed for the anemia drug Epogen.

In 2014, a company whistleblower alleged DaVita paid kickbacks to doctors in return for patient referrals. DaVita paid more than $400 million to settle that case, with $350 million paid to the federal government.

In 2015, DaVita paid $495 million to settle a whistleblower lawsuit alleging the company had defrauded taxpayers through the Medicare program. The company was accused of throwing away medication that was still usable and billing Medicare and Medicaid for the drugs. The settlement included $450 million paid to the federal government, plus $45 million in fees.

In 2021, a federal grand jury indicted DaVita and its former CEO, Kent Thiry, for conspiring with competing employers to refrain from poaching each other’s executives. Both were later acquitted.

In January of this year, DaVita disclosed that the District of Columbia’s attorney general is investigating the company’s relationship with the nonprofit American Kidney Fund, or AKF.

That investigation appears to be centered on allegations the charity may have steered patients to DaVita in exchange for donations.

In a 10-K filing with the Securities and Exchange Commission, DaVita said the attorney general is seeking copies of communications with AKF, documents related to donations made to the AKF, and communications with patients about AKF.

A DaVita spokesman said the company is cooperating with the attorney general for the District of Columbia on its subpoena that is focused “on the handful of clinics” within the district. “We aim to obtain a swift resolution of this inquiry into a relationship that was previously investigated by the Department of Justice and found to be compliant with the law,” the spokesman said.