file:///Sangfroid/#Web%20Pages/pages-archive/PCC%20Computer%20Education.%20Register%20now!

 

LEAD STORY

Whistle-blower


BY
NIGEL JAQUISS
njaquiss@wweek.com


Doctor, Refer Thyself: conflicts of interest in the dialysis industry.

Bad Chemistry: mix-ups at local treatment centers.

photos by
Michael Parrish

 

Arlene Mullin (above) says she's fighting for some of society's most vulnerable members: "In the dialysis industry, the patients need to be heard."

 

According the National Kidney Foundation, there were 230,190 Americans on dialysis at the end of 1997. The average patient's treatment costs almost $50,000 per year.

 

Each year about 20 percent of dialysis patients in America die, according to the National Kidney Foundation. Despite such a staggering mortality rate, the dialysis population is actually growing by 7 percent annually.


"They're just out to make money," says Victor Barber (above), a PNRS dialysis patient. "To them I'm just a cash cow."



This year Barber will spend 867 hours (the equivalent of 36 days) hooked up to a dialysis machine. His scarred right arm will be punctured more than 400 times with needles the size of 10-penny nails.

 

During the dialysis process, about 8 ounces of the patient's blood is outside his or her body all the time. The average patient dialyzes for about four hours three times a week.

 

Mortality rates for dialysis patients in this country are much higher than those in Europe and Japan, in part because other countries don't offer dialysis to all who need it.

 

Prior to 1972, a shortage of dialysis machines in this country meant that only those with excellent survival prospects were offered dialysis.

 


"This population is vulnerable and medically fragile," says Kathleen Smail. "It's crucial that they be able to trust their caregivers."

 

Medicare reimbursement for dialysis treatment has not risen since 1983. Locally, Medicare deems $130 the standard rate for one visit and reimburses 80 percent of that sum.

 

In April, Kaiser Permanente, which has about 170 local dialysis patients, will start dialyzing its own patients; that job is currently done by Pacific Northwest Renal Services.

 

Kaiser officials say the transition to in-house dialysis has nothing to do with recent inspections of PNRS.

 

Last year, RCGI made 23 percent of its revenues from Epogen, a drug given to help patients regenerate red blood cells. The inspector general of the Department of Health and Human Services recently proposed reducing Epo reimbursements.

 

On March 10, RCGI announced a partnership with the National Kidney Foundation aimed at patient education. The nationwide effort will kick off in Portland.

 

 

 

 

 

 
In many ways, Arlene Mullin is a perfectly ordinary woman. She has three dogs and a cat and loves to go camping. With carefully highlighted hair, a suitcase-sized purse and a high-pitched voice, Mullin seems more like your favorite aunt than Ralph Nader.

Yet the 49-year-old ex-medical technician has taken on a giant corporation--one of the fastest-growing health-care providers in Oregon.

David vs. Goliath doesn't begin to describe this battle. In the hierarchical world of medicine, Mullin is a nobody. She doesn't have a medical degree. She's doesn't even have a college degree. What she does have is a pretty convincing argument. She maintains that the dialysis industry--the business of treating kidney failure--has become assembly-line medicine, with patients zipping through clinics like cars through a Jiffy Lube.

Mullin has good cause for alarm. For 22 years, she worked as a medical technician--the last two in a dialysis clinic. Today, she works the night shift at the Vancouver Mall, selling jewelry at J.C. Penney.

The reason for the switch? Last summer, she decided to quit her job and blow the whistle on her employer, Pacific Northwest Renal Services,
a company that treats 80 percent of Portland's dialysis patients.

Victor Barber, 41, doesn't look like most people with kidney failure. The North Portland resident is 20 years younger and much healthier than most of Oregon's approximately 1,700 dialysis patients; he has neither diabetes nor hypertension, the two most common kidney destroyers. But nine years of hooking up to dialysis machines has left Barber's right arm looking as if it's been run over by a lawn mower. He used to play hoops and pedal his bike through Forest Park to Beaverton. No more.

"My life has totally changed for the worse," says Barber. "I'm tied to the machine."

Four times a week, Barber drives 18 miles to a PNRS dialysis unit in Clackamas. There, a technician plunges two large needles into artificial veins grafted into Barber's upper arm. Blood, polluted with waste his failed kidneys can't remove, courses out of his body. The blood is treated, filtered and then pumped back into his system in a process that takes more than four hours.

A typical dialysis facility looks like heaven's waiting room. A line of patients, most old and infirm, sit glumly tethered to blinking, gurgling devices the size of large slot machines. Kidney failure, unlike breast cancer or muscular dystrophy, is a low-profile malady. Instead of holding road races or telethons, the National Kidney Foundation raises money by soliciting and selling worn-out cars--an apt metaphor for the disorder.

In one way, however, dialysis patients are lucky. Kidney failure is no blessing, but it's the only chronic medical disorder for which Medicare denies no one coverage. As long as Barber lives, Medicare will pick up 80 percent of his dialysis payments. That's great for him--and for the company that provides his care.

In 1972, Congress decided Medicare would pay for dialysis for anyone who needed it, making those with kidney failure an annuity for clinics. An analyst who follows PNRS's parent company, Nashville-based Renal Care Group, Inc., says dialysis is a great business for two reasons. "Revenues are extremely predictable," says Robert Lunbeck, of Hambrecht and Quist in San Francisco, "and people on dialysis have no alternative."

On March 1, publicly traded RCGI announced that it made $36 million in 1998, an increase of 78 percent over the previous year. Such performance has made the company a Wall Street darling. RCGI's success irks patients, who feel the company's gain is their loss. "I don't like the idea of their being so profitable," says Paul Anderson, a 46-year-old PNRS patient, "but what am I to do? I'm basically a prisoner."

RCGI came to Portland in February 1998, purchasing a majority interest in the outpatient dialysis units of Oregon Health Sciences University, the Legacy Health System and the Comprehensive Kidney Center for an undisclosed sum.

Since its founding in 1996, RCGI has grown rapidly through acquisitions around the country. Its strategy has been to make sure that patients don't take their business elsewhere. To that end, they have secured key doctors--and their patients--with RCGI stock, effectively making them owners of the company. Those same physicians refer patients to clinics that they and shareholders own, which raises ethical questions (see "Doctor, Refer Thyself," page 24).

Today, PNRS--the company formed in the acquisition--treats about 750 patients in the Portland area and is headed by Dr. Joseph Pulliam, a prominent Portland kidney specialist.

Victor Barber might never have noticed that he'd been sold to PNRS--which is what the change in ownership amounts to. But almost immediately after the buyout, Barber claims, the level of care went downhill. "As soon as the contract was official," he says, "the quality of supplies like Band Aids and tape started to change."

Such concerns might seem trivial, but for patients who will be hooked up to a dialysis machine every other day for the rest of their lives, having needles fall out of their arms because tape won't stick can begin to seem like death by a thousand cuts. "When they make millions from our disability," says Christine Tabor, another PNRS patient, "it's hard to accept when they take things away."

Patients also say that since PNRS took over, the quantity and quality of staff have declined. "They've cut back on nurses by attrition," says Anderson. "People quit, and they're not replaced." Anderson, who works as an operating-room technician at OHSU when not hooked to a dialysis machine, adds that new technicians often lack basic skills such as the ability to properly insert the needles--the size of 10-penny nails--into patients' arms. A team charged with creating certification standards for dialysis technicians recently conducted a survey that supports Anderson's claim. Completed in February, the survey found that 35 percent of local dialysis technicians got their training last year.

In addition to six patients, WW spoke with 7 current and former PNRS employees. Workers claim that staffing has been cut and benefits reduced. In fact, last year several employees sent a letter to Pulliam disputing the management's assertion that there had been no decrease in staffing. Many experienced workers have left, current employees say, in part because of unhappiness with the company's insurance and retirement plans. "Nobody wants to work here because of the benefit package," one nurse says. "In order to be profitable, they're cutting corners wherever they can."

The employees WW interviewed wouldn't allow their names to be used because there is no whistle-blower protection for medical workers.

That's not a problem for Arlene Mullin.

In March 1998, the month after PNRS took over the Vancouver, Wash., facility where she worked as a technician, Mullin noticed something odd. A crucial part of dialysis is the use of solutions containing potassium, calcium and other minerals to balance patients' blood chemistry. Previously, the facility used customized, prescription solutions. Now, everybody was getting the less expensive, generic solution--a sort of one-size-fits-all approach.

Mullin claims some patients suffered from cramps and diarrhea after taking the generic solutions. On June 6, she went down to the basement storeroom and was shocked to discover barrels of the more expensive, customized solutions. She was furious, especially because she had been told that they were unavailable. "To me, that was experimentation on patients without their knowledge--just to save money," she says.

Mullin quit on June 11, 1998, writing in her letter of resignation, "It saddens me to be put in this position, that I morally have to quit something I have enjoyed--dialysis."

She contacted Medicare administrators and sent a blizzard of information to Ralph Nader and officials in nearly every state. Her package included letters from five PNRS employees and two patients. Their complaints were comprehensive--and disturbing. "Recently, twice in one week, my blood was lost in the machine (about 21Ž2 cups each time) because the attendants did not respond to the alarm quickly enough," wrote LaVonne Bell of Vancouver.

One of Mullin's letters struck a chord with U.S. Sen. Charles E. Grassley, an Iowa Republican who heads the Senate Special Committee on Aging. On July 31, Grassley wrote to Inspector General of the Department of Health and Human Services June Gibbs Brown, asking her to evaluate the quality of dialysis care and the complaint process. Brown agreed to do so.

A nationwide probe is currently in progress, according to Lynn Dugan, a senior program analyst in the Office of the Inspector General. Although Dugan says results won't be available for several months, she confirms that events in Portland prompted the investigation.

To a lot of patients and PNRS employees, Mullin is a hero, someone willing to publicly stand up to a powerful corporation and suffer the personal consequences. But Mullin couldn't have carried on her crusade by herself. Along the way, she picked up a key ally--Kathleen Smail.

Smail, a self-deprecating nurse with a shock of copper-colored hair, is in charge of health-care licensure and certification for the state.

Until 1991, the feds paid Smail's group to inspect each of the state's 32 dialysis units annually. Since then, even though annual Medicare spending on dialysis has soared to more than $10 billion, the inspection budget has been cut by 90 percent. "What that plays out to is one inspection per facility every 10 years," Smail says. "It's not enough."

Prior to PNRS's arrival, the dramatic reduction in oversight didn't seem to be a problem locally. "Historically, we've gotten few if any complaints," says Smail, who has headed the licensing group for nine years. That all changed last year. The number of complaints rose from two in 1997 to 15 in 1998.

Ironically, Mullin never sent a package of information to Smail's office. She later learned that copies of the material she sent to Nader and Grassley ended up there. Regulators in the state of Washington--also working from Mullin's material--inspected the PNRS clinic in Vancouver on July 14 and 15 of last year. Smail's team made its first inspection a few days later at the PNRS clinic at 2300 SW 6th Ave. in Portland. Both inspections turned up a number of deficiencies, but these were minor compared with what came next.

On Aug. 25, Smail sent two inspectors to PNRS's largest facility, located in Northwest Portland on the ground floor of the Good Samaritan Hospital. For three days, the inspectors grilled PNRS staff, interviewed patients and pored over medical records.

The report they compiled paints a picture of a facility in total disarray.

Inspectors found staffing to be inadequate. "Based on patient and staff interviews, the CEO has not ensured that the facility employs enough qualified personnel and that all employees have appropriate orientation," they wrote.

Short staffing had real consequences, inspectors found. Their report notes that a patient was found "hanging from his/her oxygen line, dusky skin pale, lips bluish, tubing wrapped around his/her neck and stretched from the next module."

Emergency preparations were lacking. Not long before the inspection, a dialysis patient suffered a cardiac arrest. A team summoned from Good Sam hurried downstairs, only to find no emergency supplies in the unit. The crew had to run back upstairs for equipment, losing valuable time.

Morale at the clinic was terrible. "The atmosphere was tense," the inspectors wrote. "Some patients expressed fear that errors will continue. Many expressed frustration with management. Many had negative comments of the new owners. Other patients placed blame with the physician and stated they were 'sold like chattel.'"

The damning 22-page report resulted in a "condition level failure," which meant PNRS had to file a plan of correction within 35 days or lose Medicare certification. Without Medicare, the unit would close.

PNRS filed the plan, and Smail approved it. In subsequent months, however, Smail's team of inspectors looked at five other Portland-area PNRS facilities.

Emergency oxygen tanks in two clinics were empty, and cardiac drugs were nowhere to be found. Documentation of doctors' orders and patient records was shoddy, inspectors wrote.

Common safety precautions were lacking. For example, PNRS reuses the devices that filter patients' blood. Reuse carries the risk of contamination, experts say, but is safe if proper procedures, such as taking a patient's temperature before and after dialysis, are followed. At PNRS's Southeast clinic, inspectors found that in nine out of 10 patient records surveyed, there was no documentation of temperature checks.

As the negative reports about PNRS piled up on her desk, Smail grew more concerned. Then, in mid-October, Mullin called her office to report a near-fatal accident that occurred on Oct. 9. Smail had already far exceeded her dialysis inspection budget, but Mullin's tip ultimately convinced her to inspect every facility in the state.

Mullin reported that a PNRS technician at the clinic at 2510 SW 1st Ave. had accidentally pumped Renalin into a patient's veins. Composed of hydrogen peroxide, peracetic acid and acetic acid, Renalin is used to sterilize dialysis filters and is highly toxic. When the cleaning fluid entered the patient's bloodstream, she suffered a seizure and was rushed to OHSU hospital. Had the error not been caught quickly, the patient could have died.

One month later, almost five full months after the first inspection of a PNRS facility, inspectors descended on PNRS's 1st Avenue facility. They found 23 specific deficiencies at the unit. Among the most serious: Patients weren't being left on dialyzers as long as prescribed, were given the wrong quantities of medication at the wrong times and were not having the prescribed amount of fluid drawn from their bodies. Paddles for the defibrillator--an electrical device used to restart the heart--were locked away, inspectors found, because staffers
didn't know how to use them.

Once again, Smail wrote to PNRS, telling the company it faced the loss of Medicare certification. Not only had management apparently failed to heed the lesson of the inspections in July and August, but the inspection in November resulted in perhaps the worst findings of all. PNRS submitted a plan of correction, and on the last day of last year Smail approved it.

Pulliam, PNRS's chief executive, clearly wishes he had never heard of Mullin and Smail. In fact, PNRS's law firm, Davis Wright Tremaine (which also represents WW), sent Mullin a letter last September threatening legal action if she didn't shut up. It doesn't seem to have worked.

As for Smail's findings, Pulliam strongly denies that his company has provided sub-standard care to patients but rather ascribes the problems to those typical of a company in transition. "The company was quite new, and improvements were in progress," he says.

In Pulliam's view, tighter regulation--not sloppy management--is the issue. "There aren't any more problems than before," he says. "There were no inspections before."

Smail says that historically there were few inspections because there were few complaints. That changed recently. "Last year, we got 15 complaint allegations," she says. "When we investigated, we found almost all were substantiated--and we found more problems, some of which were quite serious."

Questioned specifically about the bungled response to the cardiac arrest at the PNRS unit in Northwest Portland, Pulliam blames the hospital. "That's a Good Sam issue," he says. "That's not our issue." He denies that staff-to-patient ratios have declined.

As for the quality of care, Pulliam says that by at least one measure patients are better off with PNRS than they were before. He cites company data that shows PNRS has increased the level of waste removed from patients' blood.

As for patient complaints, Pulliam touts an internal 1998 survey that showed 90 percent of PNRS patients were either "satisfied or very satisfied" with their care, although he acknowledges that only 36 percent of patients responded.

It's clear that not everybody's happy. Two weeks ago, 34 patients at the PNRS clinic in Clackamas sent a letter to Pulliam protesting conditions there. Furthermore, Dr. Christopher Blagg, a board member of Northwest Renal Network, which monitors regional dialysis results, says dissatisfaction is probably underreported in the industry. "Because this is a treatment without which you otherwise die," he says, "I think patients are afraid to complain."

Pulliam contends that since Smail has approved plans of correction for both units threatened with decertification, the problem has been solved. "Relative to what the state has found," he says, "we have responded."

Smail disagrees. She notes that such approval doesn't mean that the problems are solved; it just means the company has an acceptable strategy for improvement and passed a reinspection. "A plan is just a plan," she says. "That doesn't mean it's working."

As for Mullin, she's still in daily contact with regulators and elected officials, trying to get people to take a hard look at dialysis. A dedicated group of 25 nurses, technicians and patients feeds her information about goings-on at PNRS. She is passionate about reform but worries about coming across too strongly. "There's a fine line between being helpful and being annoying," she says.

Being a whistle-blower hasn't been easy. Mullin's job switch--and the resultant loss of benefits--has probably delayed her husband's retirement. He's supportive, but they don't talk much about dialysis at home.

Still, Mullin has no regrets. "Our society is so self-involved that you've almost got to be a nut case to take on other people's problems," she says. "But I'd do it again."


BAD CHEMISTRY
Pacific Northwest Renal Services isn't the only dialysis provider in Portland having a tough time. Last month, two Providence dialysis units, neither of which has any connection to PNRS, gave the wrong blood-chemistry treatment to 85 patients.

The mix-up, which was covered extensively by The Oregonian and other local media, was a serious blunder. Although the error could have been fatal, state health regulator Kathleen Smail says it appears to be a one-time mistake and therefore shouldn't be lumped with PNRS's string of poor inspections. "It's important," she says, "to distinguish between an incident and a pattern."


Back to top of page

- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Willamette Week | originally published March 24, 1999

For Movie Times and Locations, See our new MovieLink site! file:///Sangfroid/#Web%20Pages/pages-archive/Portland%20Travel%20Specials! file:///Sangfroid/#Web%20Pages/pages-archive/Full%20Sail%20Brewing

file:///Sangfroid/#Web%20Pages/pages-archive/Advertiser

 

 

 

search site rogue of the week scoreboard news buzz 500 words News Stories Lead Story site map feedback search site personals classifieds web extra culture news WW home