Questions About Patient Safety in Kidney Dialysis Clinics

Critics complain dialysis clinics are often short-staffed, leading to poor patient care and infections. However, the industry maintains mandating staffing levels would force clinics to limit patients' access

Dialysis is a life-saving treatment for patients with kidney failure.

There are 66,000 Californians who depend on the treatment to live.

Critics of the current dialysis system in California are calling for legislation to increase staffing and state inspections as well as require a mandated time period between patients to reduce the risk of infections.

A broad industry coalition is opposing the Dialysis Patient Safety Act introduced by State Senator Ricardo Lara (D-Bell Gardens).

The coalition describes Lara’s bill as “a solution in search of a problem.”

The problem is real, claim critics of the industry, which include relatives of patients, some clinic nurses and social workers, as well as the 93,000-member United Healthcare Workers West.

According to the New England Journal of Medicine, dialysis is an "enormously profitable" business, costing Medicare $34 billion a year.

In the U.S. it is dominated by two companies, -- Fresenius, headquartered in Germany, and Davita, Inc., based in Denver. Both have clinics in the San Diego region.

Registered Dialysis Nurse Megallan Handford told NBC7 Investigates “when you are rushing to get your next patient on, you just can't do what you need to do.”

Handford has worked with dialysis patients for 17 years as a traveling nurse working at different clinics in different cities.

He says dialysis clinics are often short-staffed and employees are overworked and stressed, leading to poor patient care and infections.

Handford was fired from Davita's clinic in San Marcos. He currently is working at a Fresenius clinic in Fremont, California.

In the opposing corner is Dr. Mark Shapiro, who has worked in dialysis for 24 years. He’s the medical director of dialysis clinics in Poway, Escondido, and San Marcos, where Handford used to work.

Speaking for the industry, he says it supports increased inspections by the state but opposes other key elements of the proposed bill.

“I don't see evidence, anywhere, that enforcing these mandatory staffing levels will improve care," Shapiro said.

Shapiro says overall the industry provides excellent care and he opposes proposed legislation requiring the mandatory staffing levels.

The doctor adds that this puts patients at great risk.

“Mandating staffing levels would force clinics to limit patients' access to needed services,” he says.

He argues that a smaller number of patients would be able to receive the life-saving treatment in a day, putting at risk other patients who might not receive the dialysis treatment they need.

Of his other concern, the requirement to increase staffing, he says, "It becomes illegal to care for dialysis patients unless arbitrary staffing ratios are met.”

Lara said dialysis in California is a “billion dollar industry yet we treat it like a Wild West with bare minimum standards."

He introduced legislation because of “shocking stories I heard from patients and workers about the lack of protections and oversight in this rapidly expanding industry.”

With kidney disease on the rise in African American and Latino communities, he said we need to be assured that clinics “give life-saving treatment in the same way we do hospitals and nursing homes.”

Sean Wherley, United Healthcare spokesperson, says “an average of 13 patients assigned to each dialysis clinic in California died every year between 2011 and 2014. And one out of every eight of those deaths was caused by infections.”

He provides Dialysis Data.Org as his source for this information. See link here.

Kathy Fairbanks of the Protect Dialysis Patients Coalition doesn’t dispute the figures but says Wherley presents a distorted picture of conditions inside of California clinics.

“The deaths are a function of patients being in very poor health, not a clinic experience," Fairbanks said.

She adds, “In fact, California dialysis clinics are doing better than other states” when comparing infection rates.

One element of the bill to protect patients is just nonsense, according to Shapiro.

“There is this notion that somehow they are catching infections from their dialysis chairs and that is patently absurd,” he said.

But Handford sees it differently.

“Mind you, this is where cross contamination and infections can occur,” he said.

The senator added, “This transition time is crucial so we allow for sufficient time to clean dialysis machines between patients who use the same machines.”

NBC 7 Investigates reviewed state inspection records for Shapiro’s San Marcos dialysis clinic.

The records show violations including "failing to perform hand hygiene... potential to expose patients to blood-borne pathogens" that could "affect 133 patients receiving treatment.”

They also found staff not completing a "proper disinfection” of a large plastic tube placed in “a vein in the neck or groin for the exchange of blood.”

Shapiro called the findings “minor and isolated incidents” for a clinic handling hundreds of clients a year and says his staff addressed the violations immediately.

He adds, “Obviously the goal is to have no infractions at all but it is very uncommon in such a complex place that there aren't some minor infraction. See the inspection reports here.

The state's Senate Committee for Health signed off on the legislation proposed by Lara.

On that committee is Senator Toni Atkins (D-San Diego).

She supports the Lara legislation, telling us, “It really is about - do you have enough staff on site, scheduled to handle the volume of clients and make sure the quality of health care is adequate.”

She also told NBC7 Investigates, “If a situation comes up and you don’t have enough staff, that can be a serious situation.”

But the proposed bill has been put on hold.

We were told Lara wants to sit with stakeholders to tweak the legislation and reintroduce it.

Sources in the industry say the truth is Lara was concerned he didn’t have the votes to pass the legislation, that it would have never passed as written.

Michael Soller of Lara’s office responds by saying the report of the “bill’s death have been exaggerated! As anyone who knows our legislative process we have a two-year window to pursue bills. We are reaching out to companies to meet with us and see what agreement we can reach over the bill.”

NBC7 Investigates is aware of two meetings that have taken place among the interested parties but no one is saying if any progress has been made.

At the same time, the Service Employees International Union-United Healthcare Workers West, the hospital union that strongly supported Lara’s original bill, began collecting signatures in late October for a ballot measure called the “Fair Pricing for Dialysis Act.”

The act would require dialysis corporations to refund revenue greater than 15 percent of some of the cost of the dialysis care.

Since starting the effort, the union says they’ve signed up a quarter of the needed signatures to get their proposal on the November ballot.

The industry source says this ballot effort by the union is being done to pressure the dialysis clinic supporters.

Protect Dialysis Patients Coalition statement: 

 "Nothing has changed for the broad coalition of dialysis doctors, nurses, patients and other caregivers that came together over the past year to oppose SB 349. The bill is a solution in search of a problem and is dangerous for patients because it will ultimately restrict patient access to life-saving dialysis treatment. Proponents have been unable to provide any evidence that staffing ratios will lead to better care, just higher costs. These higher costs will hit the Medi-Cal program and hospital emergency rooms especially hard. Members of the Protect Dialysis Patients Coalition remain committed to quality care and will continue to oppose SB 349 because it will erode care quality and availability.”

 -Kathy Fairbanks, spokeswoman for the Protect Dialysis Patients coalition 

Union statement:

SEIU-United Healthcare Workers West (SEIU-UHW) President Dave Regan released the following statement about SB 349.

“This legislation has successfully raised awareness of the disturbing patient care problems in dialysis clinics that the industry claimed were not happening, and we are eager to have productive discussions to find solutions that improve patient care for the 66,000 Californians who need dialysis to survive. If the discussions are not productive, we will ask California voters to stand up for dialysis patients through a statewide ballot initiative planned for the November 2018 election.”

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