Lab Mistakes Threaten Credibility, Spur Lawsuits

PITTSBURGH —  When the 47-year-old woman from Ohio got back results of her breast biopsy from Magee-Womens Hospital in 1999, she faced few medical options. The lab found invasive cancer requiring immediate surgery.

She promptly underwent a mastectomy, followed by two months of painful radiation treatments, unaware that there had been a mistake.

It turned out that the hospital lab had mistakenly switched biopsy specimens. She had no cancer. The positive reading belonged to a 64-year-old Pennsylvania woman. Both women have since accepted undisclosed damage settlements in cases sealed by the courts.

In the years since, allegations of serious laboratory errors have continued to mount. At least 10 cases are pending in state courts claiming harm from lab mistakes at Magee, a prominent regional hospital for women and part of the highly regarded University of Pittsburgh Medical Center.

Physician whistle-blowers have complained about chronic lab problems and patterns of errors and sloppy record-keeping. Magee officials strenuously deny such allegations. And the lab has continued to be accredited by federal inspectors.

Such conflicts are not restricted to the Pittsburgh hospital. Lawsuits and complaints citing faulty lab operations are accumulating nationwide, naming some of the country’s top medical centers.

The number of problem labs facing threats that their accreditations could be revoked also is growing, authorities say. Some of those are in Southern California.

In Needles, for example, the Joint Commission on the Accreditation of Healthcare Organizations denied certification to the Colorado River Medical Center’s lab this year. Three other area labs were cited for deficiencies, including Kindred Hospital in La Mirada and City of Angels Medical Center in Los Angeles. The East Los Angeles Doctors Hospital was denied certification but operates under conditional accreditation granted on appeal, according to the commission.

The faulty lab operations have raised alarm among medical experts about federal oversight and inspections of hospital laboratories across the country.

Magee passed inspections by a federal accreditation agency, the College of American Pathologists, even as litigation mounted against it in the Pennsylvania courts.

And there are other examples:

* In Maryland, a hospital lab sent out hundreds of HIV and hepatitis test results despite data showing that the results might be invalid and mistakenly lead infected patients to believe they were disease-free. The same laboratory had just received a top rating from CAP inspectors.

* In Yakima, Wash., eight emergency room doctors walked off their jobs to protest hospital deficiencies they said included lab mistakes, such as mixed-up blood samples. CAP had declared the lab “in good standing” the year before.

* At the famed Mayo Clinic in Minnesota, an allegedly misdiagnosed gall bladder cancer case led to revelations of a close relationship between the clinic and CAP. A Mayo pathologist serving on a CAP advisory panel twice sought and obtained accreditation renewals despite unacceptable lab practices cited by CAP inspectors.

Such cases underscore concerns that lab mistakes are a growing national problem.

At a symposium on hospital lab quality in suburban Washington, D.C., in October, experts from around the country considered calls for improvement and closer scrutiny.

“We have problems with quality everywhere,” James Westgard, from the University of Wisconsin, told the gathering. “Our problems are systemwide.”

Meanwhile, the number of problem labs officially cited with failing grades by accreditation agencies has increased.

As recently as last spring, 10 medical labs had either lost accreditation or were “on the edge” of losing theirs, said Dennis O’Leary, president of the joint commission. He said that number had grown to 15.

“Things are not going well,” O’Leary said. “It’s a cause for urgent concern.”

At Magee, a group of whistle-blowers, including two former staff doctors, is alleging a pattern of lab shortcomings and inadequate regulatory pressure to fix it.

The Inspectors

The College of American Pathologists, based in Illinois, is one of a handful of organizations authorized by the federal government to inspect medical laboratories across the country.

It oversees about 6,000 laboratories, making inspections every two years. It also can perform unscheduled or emergency inspections.

CAP’s funding comes from the same labs and hospitals that it inspects, each of them billed for the costs of those inspections. Such direct financial ties have encountered criticism.

In 2004, CAP declared that its annual revenue was $115.5 million, which exceeded its expenses by about $15 million. The head of CAP collects about $470,000 in annual salary and benefits, federal tax records show.

Its teams of inspectors also come from the ranks of pathologists and lab technicians at the hospitals they inspect.

One doctor who attended a CAP inspection training session in 2003 said questions about how to deal with violations or misconduct seemed unwelcome. She recalled being told that the “whole purpose” of inspections was to educate, not to expose misconduct.

“The message I got was: ‘Everyone is acting in good faith,’ ” said Dr. Susan A. Silver, one of the whistle-blowers who says she lost her job after reporting Magee’s lab problems to CAP. She is suing the hospital.

Dr. R. Bruce Williams, chairman of the CAP panel that oversees lab inspections, defended the agency. He said in an interview that although education was one of the organization’s purposes, CAP “performs a very good inspection. I really think we do a good job.”

He denied that inspectors “go easy” on flaws or misconduct.

But Westgard, the lab quality expert from Wisconsin, said the nation’s lab inspection system was fundamentally flawed.

It is set up to assure compliance with regulations, but not to encourage high-quality work, Westgard said. As a result, hospital administrators under economic pressures strive for meeting the minimum standards.

“Doing the minimum to get by does not lead to quality,” he said, adding that recent changes in regulations might allow some laboratories to perform fewer checks on the accuracy of testing equipment.

The Whistle-Blowers

In December 1999, Silver, a Johns Hopkins University-trained pathologist and one of the newest members of the Magee staff, complained to a colleague about an unusual practice she encountered in the lab.

Her electronic signature had been inscribed on two pathology reports she had never seen. Pathology specimens for one patient were getting mixed up with those of another patient.

Subsequent internal hospital records, reviewed by The Times, show that patient identity errors were occurring in 7% of the lab’s Pap smear samples. The records did not show how many, if any, resulted in false diagnoses.

Silver complained that one lab staff member seemed distracted by unrelated duties, “doubling as a travel agency.” Hospital officials said the staff member was allowed to assist hospital personnel “in coordinating travel plans,” but that she did not run a travel agency out of the lab.

Veteran pathologist Dr. Kenneth S. McCarty Jr. said he looked into Silver’s complaints and found a widespread quality-control problem in the Magee lab.

He was troubled by patterns of mistakes. Sometimes test results on lab work such as Pap smears were mixed up or read improperly, he said, and patient identification errors were too common. They reported their concerns to the hospital.

Months later, McCarty and Silver got tired of waiting for the hospital to take corrective action, they said. They turned to CAP, anonymously at first, and disclosed their identities privately to the inspection agency in the summer of 2001.

Inspectors arrived to review the lab in the fall of 2001. However, CAP had called ahead. The whistle-blowers contend that the advance notice compromised the inspection, allowing lab personnel to conceal problems.

Internal e-mails filed in court show that Magee hospital officials not only knew that the inspection was coming but that it was triggered by “repeated accusations and concerns about laboratory malfunction from Magee faculty.”

The whistle-blowers contend that their identities also were compromised by the inspection agency. “All the evidence indicates that CAP did not maintain their commitment for confidentiality,” McCarty said.

McCarty and Silver were fired just before the inspectors arrived. In one e-mail, a hospital official referred to them as “terrorists.” Another e-mail from a hospital official boasted after the inspection about how well it had gone.

“A few minor citations.... [The CAP team leader said] he would not hesitate for a moment to send his family members to Magee for care,” the hospital official wrote on Oct. 31, 2001.

Inspectors reported “no credible verification of any of the allegations,” CAP’s Williams said. He acknowledged informing Magee in advance of the inspection but said it was simply intended to make the visit seem more routine. He denied revealing the identities of whistle-blowers, calling their protection “our first priority.”

Williams, who heads the committee overseeing lab inspections, said CAP recently changed its policy and would conduct inspections unannounced, beginning next year.

Silver filed suit over her dismissal a year after the inspection, saying the hospital destroyed her “career and reputation.” McCarty, who retained his tenured faculty position at the University of Pittsburgh, filed suit in 2003. Their cases are pending.

In his suit, McCarty alleges that at the time he was forced out for raising questions about lab practices, Magee administrators and their lawyers were aware “that some patients received the wrong diagnosis; some received the wrong or unnecessary surgery and treatment, including radiation.”

Both suits also cite incidents of the doctors’ signatures being electronically applied to pathology reports they did not review.

Hospital lawyers denied retaliation and said McCarty was reassigned due to “disruptive behavior.” They dismissed the false electronic signatures as “a computer glitch.”

The hospital also defends its lab as “exemplary.” Officials cite CAP’s continuing accreditation of the lab as proof that deficiency claims are unfounded.

Internal complaints have continued since Silver and McCarty were dismissed in 2001.

Donna Kovacs, an employee of Magee’s pathology department, said she and other employees were threatened for pointing out lab mistakes, including specimen slides being mixed up or sent to the wrong doctors.

She said she went to Pennsylvania state health authorities with her complaints because she was “looking out for the patients.”

One of those patients was Kovacs herself. She discovered her own Pap smear reports had been signed by a staff pathologist who never read her tests, she said.

Kovacs was fired. She filed suit against Magee under a state law protecting whistle-blowers. The hospital said she was dismissed for improperly accessing confidential patient records.

Magee in Court

Since it opened in 1915, Magee-Womens Hospital has grown to become a major regional and national center for women’s and infants’ healthcare, according to its website.

Its reputation attracted some of the patients who are suing the hospital, including one who recited Magee’s onetime slogan: “Nobody treats women like we do.”

But documented warnings from its staff and years of litigation have produced a library of potentially damaging internal records in the case files of Allegheny Common Pleas Court.

Some of those records show that Magee has struggled for years with increasing workloads at its laboratory.

In one “self-assessment report” dated April 9, 1999, hospital officials said, “Due to the inadequate staff, quality improvement has taken a back seat to completion of patient tests, which has been the priority and necessarily so.”

Records also show that the volume of Pap smear specimens submitted to the lab jumped from 77,319 in 1995 to 131,383 in 2000, an increase of 80%, while staffing increased only slightly.

Meanwhile, federally mandated reviews of past test results for cervical cancer were delayed for some patients as long as six years. In deposition testimony, a hospital official blamed a department manager’s long commute after his marriage -- from Cleveland, 135 miles away.

In another internal memo, a Magee supervisor said too many misidentified patients and erroneous Pap smear reports were being processed.

“Imagine being told that you have a negative report and then being called a week later for a [biopsy] because of a clerical error,” said a Sept. 26, 2000, memo. “We have to correct this problem.”

It was a case of switched specimens that cost the 47-year-old Ohio woman an unnecessary mastectomy a year earlier.

Tests performed immediately after surgery showed no trace of cancer, but she underwent radiation treatments anyway. Meanwhile, the cancer-stricken Pennsylvania woman waited seven months for the treatment she needed.

In a deposition, a pathologist involved in the case testified that in her 26 years at the hospital, she knew of no similar error.

“This has never, never happened, OK,” said Dr. Anisa Kanbour. “Magee-Womens Hospital is above the standard of any other hospital, and every pathologist and every physician take pride in themselves and their work.”

A similar mix-up occurred three years ago, when a Magee lab technician was interrupted while preparing a breast biopsy specimen and returned to find that someone else had completed the task.

But two specimens were mixed in the process. One had cancer; the other did not.

“The problem was discovered by serendipity,” said an internal report on the incident, luckily before unnecessary surgery was performed.

Among other legal actions pending against Magee is the case of a woman whose advanced cervical cancer diagnosis was delayed, she alleges, by misread and tardy lab results.

In her suit, Bobbi Jo Brooks charged that Magee officials issued an erroneous report indicating she did not have cancer, and then made it appear that her test had been reviewed by a licensed pathologist. Her test review, performed by a lab technician, was attributed to a fictitious Doctor D, she said.

In another case, Dona Lischner charges that faulty lab work resulted in an avoidable hysterectomy. Her lawyer says that she was the victim of “systemic negligence” and that, like her, “numerous other” Magee patients had multiple Pap smears misread.

She sued the hospital, Lischner said, to warn other women about what could happen to them. “It’s not [for] the money,” she said in an interview. “I was lucky. I’m here to talk about it. There are other women out there with lives at stake.”

Attorneys for the hospital denied that any Magee actions or inactions contributed to Lischner’s medical problems.

In a more recent case, Magee paid $1.3 million to the estate of a woman who died of cervical cancer in June 2004. She blamed the lab for misread Pap smear results that delayed treatment. Her family’s lawsuit was settled out of court, records show.

Trouble in Maryland

Two years ago, a whistle-blower focused state attention on Maryland General Hospital. The medical center had sent out hundreds of test results for HIV and hepatitis despite questions about lab equipment reliability.

CAP, which had accredited the lab, refused the state health secretary’s request for its inspection reports, prompting a showdown. Then-Secretary Nelson Sabatini threatened to revoke the accreditations of all Maryland labs certified by CAP.

CAP relented.

But the organization still regards its inspection reports as “proprietary” and refused a Times requests for its inspection reports. Officials also refused a request to identify laboratories placed on probation.

“In a way, Maryland General was a distraction,” Sabatini said. “The problem is a flawed regulatory system.”

He cited studies showing that hospital medical errors could account for as many as 100,000 deaths per year.

“The hospitals say, ‘Leave us alone, and we’ll fix it. Oh, and by the way, protect us from malpractice suits,’ ” Sabatini said. “How can you tell people to give up their right to sue with those numbers of mistakes?”

Sabatini recommends that the federal government contract directly with an agency like CAP to cut out financial ties between hospitals and inspectors.

The Yakima Walkout

Last June, eight emergency room physicians at Yakima Regional Medical and Cardiac Center resigned as a group over what they called unresolved patient safety concerns.

Among complaints detailed in their 13-page report to state health officials were allegations of “laboratory mix-ups,” including several cases “where the blood of two patients has been switched.”

One such case involved a small child who was “apprehensive about having his blood drawn.” A mix-up required doctors to take a second sample.

An off-year CAP inspection found “systemic problems” in the hospital’s lab services, and it has been placed on probation.

Sean Richardson, chief operating officer of the central Washington hospital, minimized the deficiencies as technical, saying that “certainly no patients were adversely affected.” He said allegations made by the doctors were unfounded.

Mayo Clinic Conflicts

For years, the Mayo Clinic in Minnesota has used a unique freezing and processing method to analyze tissues immediately during surgery.

The trouble is that Mayo’s slides last three days, not the 10 years required by federal regulation. The clinic has been cited repeatedly by CAP inspectors for failing to meet federal standards, yet it has received full accreditation.

That accreditation has been renewed in recent years following appeals to CAP by a Mayo official with close ties to the accrediting agency.

Records show that Lawrence J. Burgart, a Mayo pathologist, twice wrote to CAP contesting inspection deficiency notices. At the same time, Burgart was serving as a CAP advisor, heading its surgical pathology committee.

The dual roles were disclosed in a malpractice case filed by the daughter of a longtime Mayo employee who became a cancer patient at the clinic. The suit accused Mayo of misreading pathology slides, a claim leading to the discovery that the slides were not retained in accordance with federal regulations.

While CAP continued to accredit the Mayo lab, agency officials denied that Mayo received special treatment.

“That doesn’t happen,” said CAP’s Williams. “That’s not the way we operate. If anything, we would be tougher on them.”

CAP has taken a tougher line this year. On Aug. 8, the agency advised Mayo in a letter that it must comply with the more stringent retention rules “effective at the time of your next on-site inspection.”

Mayo spokesman Lee Aase said the clinic was adopting stricter specimen retention rules and would meet CAP’s deadline.

Times researchers Janet Lundblad and Nona Yates in Los Angeles contributed to this report.