by John Foxjohn
DaVita Lufkin had two bays for patients. Each bay had a nursing station that overlooked the open end of a large horseshoe-shaped arrangement around three walls of the bay, and in the center of the horseshoe, two rows of patient stations that sat back to back.
With the computers at the nursing station, the nurse could monitor how well the dialysis machines were functioning, the time patients had remaining to receive treatment, and when they needed to have their vitals checked again. DaVita required patients’ vitals to be checked every thirty minutes.
Dialysis is a lengthy process—taking hours at a time—because the body’s entire blood system must be pumped through the dialyzer, filtered and cleaned, and returned to the body. Most patients spent between three and four hours a day, three days a week doing the treatments. They were confined to sitting in the chair as their blood was drained from their body, cleansed of impurities, and put back. The comfortable patient chairs were padded and had white laminate butterfly trays on both sides that could be flipped up or down. Nurses and technicians used the trays to help hold the medicine vials, syringes, and other equipment, and they also doubled as patient armrests.
The patients passed the time differently. Some watched TV, other patients listened to music. Some talked on cell phones, while others balanced checkbooks or read, things the patients could do with one hand.
Because the same people spent the same three days a week with one another at the clinic for the same three to five hours a day, many of them became extremely astute observers of what was going on with their own treatment as well as others’. These patients often discussed their treatment with one another and noticed any variations in protocol, such as a change in medication. In many instances, some even gave one another medical advice.
Some patients didn’t care which nurse or technician administered their treatments; they’d take whoever was available. But others asked for or even demanded to have their favorite nurses and technicians hook them up to the machine. They had a preferred time and favorite chair, too, much like they probably did at home. Although some patients could be difficult, irritable, and unpleasant to be around, most were easy to get along with, friendly, and trusted their care providers.
Ms. Clara Strange and Ms. Thelma Metcalf were two of those friendly, trusting patients. They both had appointments at DaVita Lufkin on Tuesday, April 1, 2008. With light winds, a seventy-one-degree temperature, and no rain, it was a typical spring day in East Texas. April Fools’ jokes played out in Lufkin as they would all over the world.
But unlike those who could look forward to pranks and practical jokes, Ms. Strange and Ms. Metcalf would be spending about half of their April Fools’ Day hooked up to dialysis machines. One of the nurses on duty was Kimberly Saenz.
Ms. Clara Strange was born Clara Jones on November 6, 1930, in nearby Pollok, Texas, the same place as Kimberly Saenz. Although she grew up in the country, she didn’t have to worry about company—her five sisters and four brothers along with her parents provided plenty. Later, she married A. C. Strange, and they settled down and raised a family of their own.
Eventually, Ms. Strange went to work for the Lufkin State School, and she worked there until her retirement. Not that Ms. Strange sat back and took it easy—when her daughter Betty Fernandez died, Ms. Strange also raised her grandchildren.
On that Tuesday morning, Ms. Strange was put on the dialysis machine at 11:34 by patient care technician (PCT) Werlan Guillory. She had some shortness of breath when she was hooked up, but as the treatments progressed, she improved quite a bit. That afternoon when Guillory went on break, Ms. Strange was tolerating treatments well, and her blood flow rate was set at 400 cc/min as prescribed by her doctor. When Guillory returned approximately thirty minutes later, however, he was shocked to discover Ms. Strange unconscious, unresponsive, and without a heartbeat. Her blood flow rate had been changed to 300 without doctor approval or any documented reason to turn it down. Blood flow rate (BFR) is an important component of dialysis, and the nephrologist calculates the rate based on each individual patient, his or her health, as well as other factors. Basically it is the rate that the patient’s blood is removed and put back in the body. A normal slowdown of the rate might, depending on the patient, be from 400 cc/min to 390 cc/min. Normally, even when the blood flow rate is turned down, it is done in small increments because this rate affects the patient’s blood pressure.
After yelling for help, Guillory said he asked Saenz, “Kim, what is going on?” But she didn’t answer or even seem to care, he later reported.
Although the clinic wasn’t an emergency room and not equipped as such, they did have nurses and doctors there as well as a crash cart, and they constantly monitored the patients’ vital signs. Besides that, they were only a minute away from both Lufkin hospitals. Seldom did life-threatening medical situations develop without any symptoms. Nurses and doctors converged on Ms. Strange, and a PCT by the name of Cory Smith rushed the crash cart out in an attempt to save her. But nothing helped. Ms. Clara Strange died while attached to the dialysis machine at DaVita.
Ms. Strange’s death affected most of the DaVita employees deeply because she was well liked—one of those patients who was kindhearted and affable, and not a bother or trouble to the staff. They sincerely enjoyed treating her. However, they didn’t have time to grieve at that moment.
Ms. Thelma Metcalf, another of the well-liked patients who happened to be in the same patient bay as Ms. Strange, was also in trouble.
Known to her many friends as Fran, Ms. Metcalf had lived the majority of her life in Zavalla, a small town in Angelina County twenty miles east of Lufkin. Though she was born in Houston, after marrying Walter Metcalf, the couple eventually settled deep in the piney woods of East Texas. There Ms. Metcalf went about raising her family. She was a loving, caring mother who’d instilled discipline in her four children, provided support to her husband, and made time for friends and her church.
In the latter part of 2007, her health began to fail and she was admitted to Memorial Hospital in Lufkin with renal problems. In August, with her condition improving, Ms. Metcalf was released from the hospital and began outpatient kidney dialysis treatments at DaVita Lufkin Dialysis Center. However, within a few days of beginning treatments, Ms. Metcalf’s condition worsened and she was unable to walk. After an interview with Mr. Metcalf, The Lufkin News reported, “Her condition not only shocked her husband of forty-eight years, but also her family doctor. He told the family that he didn’t understand why she went downhill so fast.”
Although the sixty-eight-year-old Ms. Metcalf was a type 2 diabetic, not in good health, and had to be helped out of her wheelchair for treatment, on that April morning she was in a good mood, talkative, and her vital signs were great. Then she began her dialysis treatment.
Ms. Metcalf’s blood pressure dropped from 105/82 to 93/68 in thirty-one minutes. At 3:05 in the afternoon, just like Ms. Strange, she became unresponsive and her heart stopped beating.
Cory Smith, the PCT who had rushed the crash cart to Ms. Strange in that unsuccessful attempt to save her, had not even gotten it put away before Ms. Metcalf coded. After grabbing another breathing device—he’d just used the one on the cart on Ms. Strange—he rushed the crash cart back to try to help Ms. Metcalf.
He handed Saenz the breathing device and she placed the mask on Ms. Metcalf and started operating the breathing pump while another nurse did chest compressions. As they did CPR, Smith noticed that there was no rise and fall of Ms. Metcalf’s chest, which indicated that no oxygen was getting into her lungs.
Smith told Saenz that she had to open Ms. Metcalf’s airway, but Saenz didn’t respond.
He told her two or three more times, but Guillory said Saenz not only never responded, but never even acknowledged that he was talking to her. Finally, Smith said, “Let me do it.” He took the breathing bag from Saenz and attempted to clear Ms. Metcalf’s airway and then put the mask
back on, but it didn’t do any good. Ms. Metcalf was rushed to the hospital, where EMTs administered three doses of epinephrine, a drug used with cardiac arrest patients to attempt to revive them, but it was too late.
Ms. Metcalf became the second patient to die on the dialysis machine at DaVita Lufkin—and within five minutes of Ms. Strange.
After Ms. Metcalf was rushed to the hospital, employees discovered that her blood flow rate had also been turned down from 300 to 200, and again without doctor approval.
The correct blood flow rate is crucial for every dialysis patient. Obviously, too much blood cannot be removed from the body at once, so usually no more than a pint of blood is outside the patient’s body at one time. An alarm system is triggered if the blood flow rate falls too low.
An air detector also triggers an alarm in the event that air enters the bloodlines, which can be deadly. Yet another alarm system checks for foreign substances that shouldn’t get into the patients’ bloodlines and be brought into the body. If these or any other problems occur with the machine, the alarm is set to go off and stop the blood flow of that patient—therefore eliminating the harmful things from entering the patient’s blood.
However, if a foreign substance were introduced into the lines in any way, slowing the blood flow rate gave that substance time to be diluted with the blood, and therefore reduced the chance of the alarm going off. If the alarm didn’t go off, the blood continued to flow, carrying the substance throughout the patient, and the staff would not be alerted to the problem.
Neither Ms. Strange nor Ms. Metcalf’s alarm systems went off that day—and both were found with lowered blood flow rates.
Dr. Imran Nazeer, a nephrologist and the medical administrator of DaVita Lufkin, later said that in all of his twenty-three years as a kidney doctor, he’d never before seen a patient die of a heart attack while receiving dialysis, and he’d only ever even heard of two such cases. The chances of one patient dying of cardiac arrest while on a dialysis machine are something in the neighborhood of 7 in 100,000. The odds of two patients at the same facility dying of cardiac arrest within five minutes of each other while on a dialysis machine are beyond astronomical. What’s more, neither Ms. Strange nor Ms. Metcalf had exhibited any sign of heart problems before they suddenly both died of cardiac arrest.
Ms. Metcalf’s family had her cremated. After a service in Zavalla, they took her ashes to a creek in Arkansas where she’d played as a child and spread them there. Seldom does a cremation play a vital role in a trial, but four years later, this cremation did.
CHAPTER 4
INQUIRY
The truly anomalous circumstances of Ms. Strange’s and Ms. Metcalf’s deaths on April 1, 2008—two cardiac arrests within five minutes of each other while on dialysis machines in the same facility—spurred DaVita officials to take immediate action. They brought in independent investigators and monitors led by DaVita’s regional director, a registered nurse named Amy Clinton. Although DaVita Lufkin had a facility administrator, an RN named Sandy Lawrence, as of April 2, 2008, Clinton assumed all responsibility for the operation of DaVita Lufkin. Clinton’s team specialized in problems dealing with dialysis centers, and their mission was quite simple: find the problems affecting the patients and stop them.
Unfortunately for Clinton, she stepped into a mess. DaVita Lufkin was not known as a model dialysis facility, and the problems went back as far as 2003.
In order for dialysis centers to operate, they have to receive what is called a CMS reimbursement. The Department of State Health Services, who oversees dialysis clinics in Texas, is required by federal law to conduct a surveyed inspection of each dialysis center every three years. This is how the facilities receive the reimbursement.
On April 8, 2003, one of the survey inspectors toured DaVita Lufkin and, while observing the process, determined that the reuse technician did not properly process used dialyzers according to standards set by AAMI or, for that matter, DaVita’s own procedure. This is vitally important. The dialyzer is what the patient’s blood goes through to purify it.
At the same time, the inspector found that DaVita had not properly trained its staff.
On June 2, 2003, the Department of State Health Services conducted a follow-up survey of DaVita Lufkin, and after that return trip, they reported that DaVita Lufkin had not corrected infection control problems that they’d found in the inspection two months before.
After DaVita corrected these problems, the Department of State Health Services returned on May 23, 2006. Again they found problems. This time the inspectors found that DaVita Lufkin was not properly documenting its test results on the water or on discharge summaries on patients who’d died, or their cause of death.
The Department of State Health Services had let three years pass from 2003 to 2006, but then they were back in July 18, 2007. This time the state inspectors found that DaVita Lufkin did not have the required number of properly trained personnel present to meet the needs of patients.
Not only that, but the inspectors found that, at times, the facility had not given patients the correct treatments as ordered by the doctor. While there, two employees came forward and told the inspectors that they were administering treatments against a physician’s orders because the facility administrator told them to.
Another problem the inspector found in 2007—which would also be a headache for Amy Clinton in 2008—was that DaVita Lufkin had a part-time biomedical technician, commonly referred to as bio-med. He spent part of his working time in the clinic in Lufkin, and the other part of the time in Livingston, Texas, a small town 70 miles to the south.
In 2007, the inspector at DaVita Lufkin observed that the center ran out of a mix used to treat the water. The problem: the only person who knew how to mix the chemicals was in Livingston that day.
No one can or will say that these problems contributed to a higher death toll for DaVita Lufkin patients than other clinics. It also must be noted that dialysis patients tend to have a higher death rate than other patients. However, from January 1 to December 31, 2007, twenty-seven DaVita Lufkin patients died. This is 7.1 percent higher than the state average.
The results were no better in 2008. From December 2007 to April 28, 2008, some of this on Amy Clinton’s watch, DaVita Lufkin had nineteen patients die—including Ms. Metcalf and Ms. Strange, the ones whose deaths threw DaVita officials into a panic.
Even with Amy Clinton and all of her monitors at the clinic from April 2 until April 28, DaVita Lufkin rushed thirty-four patients to local hospitals by ambulance.
These were the problems Clinton faced as she assumed the responsibility of the clinic. However, before she could fix the problems, she first had to identify what they were.
First, Clinton and the monitors examined all aspects of the biggest part of a dialysis clinic, the water used in the dialysis process. Purified water plays a vital role in dialysis, and the Lufkin clinic had a water treatment room where they purified their own water.
Because the purification process was so complex, the investigators checked every aspect of the system, from the water itself to the equipment. There was an alarm on the water system designed to alert everyone throughout the clinic if something went wrong with any aspect of the water purification. However, like all the other equipment in the purification area, the investigators found nothing wrong with the alarm system, the purification system, or with the water itself.
Next, the investigators looked at the biomedical technicians who maintained the water system. They checked the techs’ qualifications, work history, as well as all the paperwork that went along with the job. Like the equipment, the techs and their records weren’t the problem.
Next, the investigators checked the reuse technicians and their on-site reprocessing area. This was where the patients’ hemodialyzer—basically the filter that removed the impurities in a patient’s blood—was cleaned, sterilized, and made ready for that p
atient’s next treatment. DaVita Lufkin used both new and reuse dialyzers, but there were strict guidelines on the cleaning and maintenance of the reuse dialyzers and the patients had to agree to use them. Although the survey inspection team had found problems in this area in 2007, DaVita had corrected them, and Clinton’s team could find no problems in this area in April 2008.
After not finding the problem in the reuse area, the DaVita officials checked all the dialysis machines themselves, but again failed to find a problem.
Everyone at the clinic, and that included the investigators, believed that something on-site was causing the problems, but they’d checked the trouble-prone areas and had determined that those weren’t responsible. Next they checked the clinic’s policies and procedures to see if it was anything the technicians and nurses were doing that could be killing and harming the patients. The investigators looked at every procedure and could find nothing that could contribute to the fatalities and complications if the employees followed all procedures as prescribed.
Last, they checked the patients themselves. Like all dialysis facilities, DaVita took the patients’ vital signs before treatment, several times during treatment, and after treatment. If the patient had a serious medical problem before or during treatment, their vital signs should so indicate, and the DaVita staff could get them medical help. This was one of the reasons that it was so unusual for a patient to die while hooked up to the machine. The patient had constant monitoring from medical professionals.
However, according to their recorded vital signs, none of the patients who died at DaVita or suffered serious health complications while undergoing treatment began with problems. The problems began after they started their treatment, and they happened suddenly.
The officials checked three areas where dialysis patients commonly had problems: blood pressure during treatment, heart rate, and edema, aka swelling—usually from a buildup of fluids.
