Criminal allegations against a former Davita nurse are unprecedented in the dialysis industry, said company officials who are working with state health officials to reopen the Lufkin center.
Administrators at the 700 S. John Redditt Drive dialysis center closed the facility's doors and contacted police, state and federal health officials in late April after reporting a spike in patient deaths and health complications. Lufkin police on May 30 arrested Kimberly Saenz, 34, a licensed vocational nurse, and charged her with two counts of aggravated assault for allegedly injecting two patients with bleach. While both of those patients survived, company officials said they strongly believe Saenz is also linked to a cluster of four patient deaths in early April. Police have not filed any charges related to those deaths.
DaVita officials disclosed more information Wednesday morning about the company's internal investigation it conducted after patients died and others experienced serious health complications in April.
DaVita's internal investigation
DaVita spokesman Michael Chee said the company had already been looking into complications at the Lufkin unit in early April and conducting its own analysis before it alerted police and health officials.
Dr. David Van Wyck, a nephrologist who is vice president of clinical services for DaVita and working with state officials during the investigation of the Lufkin clinic, spoke to specifics of the investigation.
"We noticed a cluster of deaths in early April and responded immediately. The kind of response that we do when we see a cluster of events like this is break it down into four major areas: water, machines, policy and procedures and specific patient issues," Van Wyck said.
To do the investigation, the company brought in specialists to check on the different areas. Van Wyck said the water and machines checked out. And there was nothing in policy and procedure, such as someone not following them, that would have contributed to that cluster of events, he said. Specialists then considered the possibility of chance, Van Wyck said.
"When we took all of the findings together, we were completely perplexed. And that is very, very unusual for a cluster of events," he said.
Chee said the company could not find anything to explain the cause of deaths until April 28. On that day, two patients said they witnessed Saenz allegedly injecting two other patients with bleach, and alerted senior staff at the facility.
The company spokesman said the unit had been on a heightened state of awareness for several weeks leading up to the incident. When the incident was brought to staff attention, the patients allegedly injected were sent to a local hospital and Saenz was sent home, Chee said. The company fired her the next day.
Chee said the company did not shut down sooner because there was "no single, causative factor it could put its finger on."
"If we had shut down sooner, we would not have known this was going on. We would not have had the opportunity for this act to be witnessed," Chee said. "It is possible we would have never have known."
There were no deaths at the facility between April 3 and April 25, Chee said. He would not say how many deaths occurred in April.
Tubing used to administer dialysis to the four patients who died was kept and frozen by staff as evidence, Chee said. Blood drawn from patients who exhibited complications, beginning in mid-April, was tested and preserved also, the spokesman said. All of that evidence was turned over to police detectives when the facility contacted them.
"We do that as a part of standard epidemiological procedure," Van Wyck said.
Bleach use at facility
On Friday, the state health department sent a letter to several patients answering possible questions about blood test results for bleach that were recently determined. A state spokesman would not disclose the number of patients the letter was sent to, but did say letters were sent to both patients and family members of patients who had died. Blood was drawn from DaVita patients between April 16 through May 2 and tested by LPD for possible exposure to bleach, the letter stated. The letter then goes through a series of questions and answers about the effects of bleach exposure.
Chee said it is not part of DaVita's training or procedures to have nurses or staff draw bleach into a syringe. He said diluted bleach is used at the company's facilities to wipe down areas where patients have been treated. The facilities clearly label the bleach solution and store it away from treatments, the spokesman said.
He offered no motive for Saenz about the allegations brought against her, but called her "a very deceitful person."
"This was a person trying to hide their actions, we believe," Chee said. "That's part of what made it hard to figure out what was going on. And that's also why we think it's important we did not close sooner than we did or we might not have ever caught that, and that person might still be out there working at another facility doing these things."
Saenz's attorney has declined to comment.
The former nurse had worked for the company eight months and underwent 10 weeks of dialysis training because she had no prior experience in the field. Chee said the company conducted a background check, but did not discover a 2005 disciplinary action taken against Saenz until after the company fired her April 29 — a day after it closed the center. Woodland Heights Medical Center, where Saenz worked in August 2005, had filed a complaint with the state nursing board, accusing Saenz of stealing Demerol — a narcotic pain killer — from the facility and its patients. It was one of two charges used to suspend Saenz's nursing license in May 14. The other charge stemmed from recent police allegations.
"All these background checks were performed and nothing usual came up," Chee said.
State survey findings
While no reopen date has been set, Chee said he hopes the facility to be open and operating by the end of June. A letter to the facility released by the state in early June stated the department found the facility had potentially serious or life-threatening risks to patients based on a survey conducted in May. The state is requiring DaVita to abide by the highest level of corrective action before reopening, which included hiring four staff monitors to the Lufkin facility.
DaVita has hired a monitoring physician, two nurses and a dialysis technician as required, Chee said. It has also completed its corrective plan of action, which it submitted early last week, and is wrapping up additional staff training.
The state survey report, expected to be released in the coming days, has not found any link between deficiencies cited at the facility and the allegations made against Saenz, Chee said.
The center has had a history of being non-compliant with state standards, according to state surveys obtained by The Lufkin Daily News through open records.
A survey conducted in July 2007 at the Lufkin center stated staff had administered treatments to patients against doctors' orders. The surveyor noted she discovered the errors and told the facility administrator. She remained at the facility for the day until patient treatments were corrected, a state spokeswoman said. The surveyor returned a month later and documented the facility was in compliance with its corrective plan of action.
Surveys conducted in 2003 and 2006 showed reuse technicians were not properly reprocessing used dialyzers according to AAMI standards and the company's own reuse policy. A follow-up survey to the 2003 report found the center had not corrected infection control problems. Another follow-up survey conducted a month later found the center was in compliance, a spokeswoman said. A follow-up report to the 2006 survey also found the center had complied.
Chee has called those survey reports isolated incidents, saying there is no connection between those reports and the current investigations.
Working toward a reopen date
While the nursing and technician staff has remained the same, the company has hired a new facility administrator. The facility administrator is new to Lufkin but not to dialysis and comes with experience, said Gina Randolph, senior vice president of DaVita. The former FA has transferred to another DaVita center where she is working as the clinical coordinator for that facility's administrator, Randolph said.
"She feels victimized by what's happened," Randolph said.
The company executive said DaVita has provided counseling for staff who have reached out, and some have taken advantage of it. Patients are not being provided counseling by the company and none has reached out for it, Chee said.
Since the center's closure, approximately 130 patients have been bused, at the company's expense, to area dialysis centers for treatment, Chee said. A social worker stationed at DaVita has been in constant communications with patients, often riding the bus with them, Randolph and Chee said.
"The message we are getting from patients is we want to come back and we are ready for the facility to reopen and come back home," Randolph said.
She said all but two patients are anxious to return.
"That's only two of 130," Randolph said.
The two who have decided not to return did so because they live closer to the other locations, the company executive said.
DaVita has more than 1,300 dialysis outpatient centers across the nation, servicing more than 100,000 patients. Like all dialysis centers, it is a place patients hope will be a stepping point before undergoing a kidney transplant.
Dialysis is a process that removes waste from a patient's blood, taking on the kidney functions as clean blood is filtered through the body.
Patients undergo an average of three weekly treatments at three-hour increments, experts say, of which treatment costs are largely paid for by Medicare reimbursement.
