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Authors: John Foxjohn

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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 patient'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.

One thing that gave them some pause was the heparin that the DaVita clinic was using. Heparin is a common drug used in dialysis to prevent blood clots in veins, arteries, and lungs. Given that the patients' blood was being removed and put back in their bodies after traveling through a filter, the chances of clots were high. There had been a manufacturer recall of one brand of heparin, however, and even though it wasn't for the brand DaVita was using, the investigators gathered up all their heparin, and brought in another batch from a different facility. In the end, this didn't help either.

The stumped investigators and administrators didn't have a clue as to what was causing the problem. In a last-ditch effort to find anything that explained it, they even looked at the possibility of simple chance, but like everything else, they eventually ruled this out, too. The odds of the two deaths simply didn't allow for it to be a chance occurrence.

During this time, two of the nurses made the same comment: “The only thing they didn't check was the employees.” Indeed, they hadn't. They didn't think they needed to; they believed that medical professionals wouldn't intentionally harm their patients.

After Clinton's arrival, the problems at DaVita ceased for a short time. But that moment of calm turned out to be merely the eye of the storm—a temporary respite before a horror that no one had seen before, or even imagined, fell upon DaVita.

* * *

Wednesday, April 16, 2008, was a gorgeous East Texas day. Temperatures were in the sixties, skies were clear, and there was just enough of a breeze to cool off those who were working outside, as Mr. Garlin Kelley Jr. was that morning. Neighbors walking or driving by his home routinely saw him outside doing yard work, and honked at him or waved and yelled hello. Most of them knew that he wasn't in great health—one of his legs had been amputated and he was learning to use a walker to get around.

Just the sight of a man with one leg doing yard work drew some attention. But this wasn't just any man. A ring of respect jingled in everyone's voices when they said Mr. Kelley's name.

Mr. Garlin Kelley Jr. was born and grew up in segregated Lufkin, and he'd lived in segregated neighborhoods and attended segregated schools all the way up through college in the late 1960s and early 1970s. It had taken East Texas a long while to get on board with integration. In fact, Dunbar High, Mr. Kelley's alma mater, did not integrate until 1970, and only then because the school district was forced to do so by a federal court order. These experiences could have had a negative effect on anyone—caused feelings of prejudice or harbored anger—but not with Mr. Kelley. Even early on, his friends said that he recognized that it wasn't up to him to judge others, and that as he had no control over how other people felt, it did him no good to worry about it. He would let the Lord judge him on who he was, and others on who they were.

As a boy, young Garlin and his friends would go to watch the Dunbar Tigers play every Friday night in football season. Dunbar High School had hired a coach by the name of Elmer Redd, who became a legend not only in Lufkin, but in the entire state of Texas. Dunbar had an abundance of talented athletes, but it was Coach Redd who molded that talent into state championship winners. Growing up in this environment, Garlin Kelley dreamed of playing football for the coach. He watched Tiger players like future NFL hall of famer Ken Houston receive college scholarships, and dreamed that he could, too, someday.

As Garlin entered junior high, he was smaller than many of the other boys, but that only meant that he had to work harder. From his parents and coaches, he learned the value of hard work, honesty, education, and the Good Lord. With encouragement and teaching from the coaches, and his own willingness to work and push himself, he progressed, and by the time he reached high school, Garlin Kelley was a force to be reckoned with on the football field.

Owing to hard work, desire, and plain old heart, Garlin Kelley first became an all-district player, and then was voted as an all-state player. He was instrumental in helping Dunbar High bring home three more state championships in his four years of high school. He was offered a college scholarship to Prairie View A&M University to play football. He would be following in the footsteps of not only one of his heroes, Dunbar star Kenny Houston, but also his mentor. Coach Redd had also attended the school.

Garlin Kelley never gained the stardom that Houston did in college or in the National Football League, and he wasn't a first ballot Hall of Famer like Houston. But in 1966, Garlin Kelley won a whole lot more than football games—he also won the heart of a young lady named LaFrancis. Infatuation turned to puppy love, and continued to grow into a deep friendship and a lifelong love affair. After graduating from college, Mr. Kelley soon accomplished his greatest feat—he married LaFrancis.

Mr. Kelley first worked as an insurance agent and later for the Lufkin Independent School District. However, his love for football never ended. Through most of his adult life until his health failed him, he refereed high school football games.

Over the years, the Kelleys had three daughters: Ulrica, Angela, and LaTonya, and Mr. Kelley couldn't have been any prouder of them. He instilled in them the same values he'd learned from his parents and coaches, and all three girls graduated from college.

Then at the age of fifty-three, Mr. Kelley was diagnosed with renal failure. It took a while, but he finally had a successful kidney transplant. For a while, things looked good, but three years later, the kidney gave out and Mr. Kelley had to start dialysis. He began treatment at the DaVita Lufkin Dialysis Center. The doctors later said that he was in excellent health considering the problems he had; in addition to his kidney problems, Mr. Kelley had type 2 diabetes, COPD, and hypertension.

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