CEO SUMMARY: This widely-reported case of misdiagnosis at an Allina hospital in St. Paul, Minnesota is a powerful reminder to pathology practices and clinical laboratories that breakdowns in medical quality will draw increasing attention and scrutiny. Both the patient and the community are questioning why the pathologist who made the mistake will apparently be allowed to continue to practice without serious sanctions.
BY NOW, MOST of the pathology profession knows last month’s story of the Wisconsin woman whose double mastectomy proved unnecessary because of a false diagnosis of breast cancer.
It got wide play in the national media because it was the classic story of human tragedy. A woman, told by her doctor that she had an aggressive form of breast cancer, opted to undergo a double mastectomy. Two days after the operation, her doctor informed her that she never had breast cancer in the first place—the operation was unnecessary.
For pathology group practices throughout the country, this widely-publicized case of misdiagnosis should trigger a careful assessment of internal quality control protocols. Of equal importance, however, THE DARK REPORT believes that pathology group practices should use this case of cancer misdiagnosis as a catalyst to reassess and understand basic changes now occurring in the way American society views its healthcare system.
Specifically, consumers are increasingly intolerant about medical errors. There is a groundswell of support for publicizing provider performance and taking decisive action against physicians who seem to be regularly delivering substandard care.
In the double mastectomy case, the basic facts are not in dispute. Last May, Linda McDougal, a 47-year old accountant and mother of three underwent a mammogram at the breast center of United Hospital in St. Paul, Minnesota (owned by Allina Hospitals and Clinics). A suspicious shadow on the mammogram caused her physician to order a biopsy.
Slides prepared from McDougal’s biopsy were read by a pathologist at Hospital Pathology Associates (HPA), the 25-pathologist group which provides anatomic pathology services to most of Allina’s 14 hospitals. At HPA, it was common practice for several patient’s slides and paperwork to be placed in a single folder. While reading McDougal’s slides, the pathologist mismatched the specimen slides and paperwork of McDougal and another woman.
Post-operation, no malignancy was found in the amputated breast tissue. In reviewing McDougal’s case, HPA’s pathologists discovered her specimen slides had been mistakenly identified as those of another woman whose slides and paperwork were in the same folder. The patient who actually had cancer was than contacted and treatment for her cancer was started.
Although these events occurred in May 2002, it was not until January 20, 2003 that McDougal felt emotionally strong enough to hold a press conference and tell her story to the public. In the months since her operation, she has been plagued by serious infections and has undergone emergency surgery. Her reconstructive surgery will be delayed for as long as two years.
Changing Public Attitudes
What pathologists and laboratory executives will find instructive about this case is how it plays into a new public attitude and intolerance for medical errors of this type. For one thing, McDougal now understands what pathologists do.
McDougal appeared on morning television talk shows and was widely quoted in the nation’s newspapers. “It’s important for me to get a message across to women to take control of your own medical care,” she declared. “Just because a pathologist or a doctor tells you something, especially in the event of a serious diagnosis, they could be wrong. I did talk to my family practitioner. I talked to other doctors about the surgery itself, but it never occurred to me to question the pathologist report.”
“They have been wrong. They were wrong with me and caused me to have both of my breasts removed,” she continued. “I trusted them and I shouldn’t have. Just because a pathologist or a doctor tells you something doesn’t mean it’s right. You have to be true to yourself and get a second opinion or a third.”
Holding Docs Accountable
McDougal was accompanied during her public appearances by an attorney and is speaking out against the President’s proposed limitation on medical malpractice awards. “Doctor’s aren’t held accountable,” stated McDougal. “It has taken me seven months to get to a point where I can even talk about this.”
McDougal was critical of how the medical establishment responded to her case. She noted that, although the surgeon had apologized, neither the pathologists nor the hospital had apologized until the news became public. She characterized public apologies made by officials to the media thusly: “It’s so obvious that it is a public relations thing that it is meaningless.”
McDougal was also upset that the pathologist, as of yet, had not been disciplined in any serious way. “I think he’s got to be penalized,” she declared. “He’s got to be accountable, and right now they haven’t even slapped his wrist.”
Because of legal issues, HPA has offered only limited public comments. Pathologist Laurel Krause has spoken on behalf of Hospital Pathology Associates. “A tragic mistake was made,” she said. “We are exceedingly sorry for the pain and suffering she [McDougal] went through, and she has continued to go through.”
An Exemplary Record
The pathologist who signed out McDougal’s case has not been identified. But Dr. Krause did note “the pathologist who made this error has an exemplary track record. There has been no prior history of any such mistakes or errors.”
HPA is revising its work procedures to prevent such errors in the future. It is now color-coding tissue samples to a patient’s paperwork. In signing out cases, two pathologists are now required to sign after cross-checking the patient name and ID number on the slide with the case documentation. “It is more time-consuming and more effort,” commented Dr. Krause, “On the other hand, that’s not what matters here. What matters is getting it right.”
Across the country, pathology group practices have responded to the this tragedy by launching a review of their own work procedures. Allina spokes-person Kendra Calhoun said “We’ve been receiving e-mails and phone calls from pathologists and labs across the country to ask what we’re doing differently so they can make their own protocol changes. It’s not about anything except patient safety. That’s our main priority.”
Many pathology group practices handle slides and paperwork in a similar fashion as was done at HPA. “There, but for the grace of God, goes any one of us,” said one Minneapolis-based pathologist to THE DARK REPORT. He observed that procedural changes were rapidly implemented by his group immediately after news of the McDougal case became public.
On balance, however, THE DARK REPORT notes that the laboratory industry continues to maintain a pretty good track record on patient safety. During the past five years, only two episodes of laboratory errors have caught the attention of the national media. In Palo Alto, California, a rogue phlebotomist at SmithKline Beecham Clinical Laboratories was discovered reusing needles. In Philadelphia, the laboratory at St. Agnes Medical Center generated inaccurate test results over a seven-week period that affected patients taking Coumadin. (See TDR, June 7, 1999 and August 13, 2001.)
“There, but for the grace of God, goes any one of us,” said one Minneapolis-based pathologist to THE DARK REPORT.
What is significant about the Linda McDougal case is that it demonstrates the ongoing evolution in public opinion toward medical errors and physician incompetence. Even as the medical community closes ranks around the pathologist who committed the unfortunate error, as has always been true in the past, strong voices in the consumer community want tough action. They want the name of this pathologist to be publicly disclosed and they want tough sanctions leveled against the pathologist proportional to the harm done to Linda McDougal.
Pathologists and laboratory directors should heed this change in public expectations. Public scrutiny of healthcare professionals who commit medical errors will continue to increase in future months and years.
Probability of Nosocomial Infections Not Discussed In McDougal’s Case
EVEN AS LINDA MCDOUGAL’S UNNECESSARY double mastectomy grabs national headlines, neither she nor her attorneys have commented publicly on the source of her serious infections.
It was easy to track the source of her misdiagnosed breast cancer back to the pathologist who misidentified the slides of two different cases. But it is less easy for McDougal to identify the source of her infections, most likely transmitted during her stay in the hospital.
For the most part, consumers do not understand that many nosocomial infections are preventable if staff in a hospital follow well- established procedures. Consumers thus generally do not “blame” their hospital for infections contracted during their stay.
Accordingly, McDougal and her attorneys publicly decry the mistakes made by the pathologist reading her case, but have yet to attribute or speculate that McDougal’s infections may be the result of a breakdown in the hospital’s infection control procedures.
THE DARK REPORT believes this is a good illustration of how consumer expectations (and knowledge) play a role in demanding improvements in healthcare quality. The pathologist’s error which generated the misdiagnosis is easy to comprehend and caused a human tragedy—needless removal of a woman’s healthy breasts. But one consequence of that mastectomy, serious infection, has so far been accepted by the consumer and her legal counsel as an inevitable result of the surgery and is not considered a medical error that might have been avoided.
Thus, it is with some irony that the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) weighed in on nosocomial infections just two days after McDougal’s case came to the public’s attention. On January 22, 2003, JCAHO issued a Sentinel Event Alert calling for greater reporting of the deaths of patients who contract fatal infections while being treated for illnesses or injuries.
JCAHO’s concern explains why many consumers “accept” nosocomial infections as a part of their course of treatment. In its alert, JCAHO quotes CDC estimates that more than two million patients yearly develop infections while hospitalized for other health problems. Of this number, up to 90,000 die as a result of these infections.
Remarkably Few Reports
Remarkably, JCAHO reports that, despite these large numbers, hospitals have only filed ten such reports covering 53 patients during the past seven years! “We are receiving a dis- proportionately low volume of reports on the number of patient deaths from infections acquired in the health care setting, possibly because many health care organizations do not view these events as ‘errors’ under the definition of a sentinel event,” says Dennis S. O’Leary, M.D., JCAHO’s President.
It is a situation that JCAHO intends to change as part of the move to improve patient safety. O’Leary explained, “…in view of the importance and high visibility of such occurrences, we are urging health care organizations to share this information with the Joint Commission, just as they might share information about other types of sentinel events with us.”
JCAHO’s initiative to focus attention on nosocomial infections will come to the attention of consumers—who, not surprisingly, will come to view such infections as unnecessary and a result of improper healthcare. In the future, patients such as Linda McDougal will include nosocomial infections in their list of malpractice torts. Because labs play an important role in infection control, this new emphasis on nosocomial infections will require greater awareness and involvement by laboratorians.