A recent Johns Hopkins’ study found that a young woman suffered for 1 1/2 years because of a medical testing error that could have been prevented.
The young woman’s experience is not unusual; diagnostic errors such as these cause billions in malpractice claim payouts and pose a significant patient safety risk in the United States.
The Poughkeepsie Journal reports:
“This is more evidence that diagnostic errors could easily be the biggest patient safety and medical malpractice problem in the United States,” says Dr. David E. Newman-Toker, Ph.D., an associate professor of neurology at the Johns Hopkins University School of Medicine and leader of the study published online in BMJ Quality and Safety. “There’s a lot more harm associated with diagnostic errors than we imagined.”
For Noto’s daughter, the harm started with high fevers that her then-4-year-old was having on a regular basis.
“Allie was having 103-104 degree fevers,” said the Town of Poughkeepsie mother of three. “The doctors ran a lot of basic blood work and it all came back negative.”
As a next step, Allie’s doctor wanted to test for a condition called Familial Mediterranean Fever, which, according to the Mayo Clinic, is an inflammatory disorder that causes recurrent fevers and painful inflammation of the abdomen, lungs and joints. Noto and her daughter traveled to the genetic testing center in Maryland, used by the National Institutes of Health, where they swabbed her cheek. Noto waited. The test came back positive. There is no cure.
The NIH brought Noto and her daughter back, took more blood and put Allie on medication that caused her to have severe painful cramps.
“We were also told she would go into renal and kidney failure and wouldn’t have a long life,” she says. “The medication caused other side effects including neuropathy (weakness) in her legs and arms.”
Noto, who had been suffering from some of her own ailments, decided to also be tested for Familial Mediterranean Fever, too, when she found out that there had been a lab mix-up.
“We got a call from the lab and found out that Allie’s DNA was mixed up with the DNA of a 41-year-old man,” she says. “I was angry and upset, and I felt terrible for her. I also had a fear of losing my daughter. We were referred to an ENT because of her red throat, and all she really needed was her tonsils out. The fevers never came back.”
It was a terrifying experience for Noto. Unfortunately, many patients around the country go through similar experiences. One local doctor wants to make sure that this doesn’t happen to his prostate cancer patients when they have their biopsies.
Dr. Evan Goldfischer at Premier Medical Group in Poughkeepsie has adopted a test designed to detect these errors and safeguard men from life-altering treatments.
“Things can get mixed up all the time,” Goldfischer says. “Mine got mixed up, and I don’t even have cancer. It’s infrequent, but it does happen.”
According to a recent study published in the American Journal of Clinical Pathology by Dr. John Pfiefer, as much as 3.5 percent of 13,500 prostate cancer biopsies included in the study were not a DNA match. This means that more than three in 100 cancer-free men are told they have cancer, setting in motion unnecessary treatments (e.g. removal of healthy prostates in cancer free patients, radiation therapy, chemotherapy, etc.). These mistakes can also delay life-saving treatment for patients who do have cancer.
Goldfischer says the doctors wanted to reassure patients that the positive results were, in fact, theirs. He and his practice are using the know error system, which can detect these errors before the result is provided to the patient. The test compares a DNA cheek swab taken at the time of the biopsy against a positive result, ensuring each patient receives their result.
According to the know error website, Specimen Provenance Complications are a serious concern for both physicians and patients. These are mistakes in testing due to such problems as specimen transposition, foreign cell contamination and patient misidentification. Specimen Provenance Complications arise due to instances of specimen transposition, foreign cell contamination and patient misidentification.
“We take a Q-tip and swab the patient’s cheek and place it in a sealed plastic bag and box,” Goldfischer said. “We treat it like you would a piece of evidence. Then we take a slide of the cancer cells from the biopsy, put it in a tube and send it off to the lab. If the biopsy comes back positive, they open the specimen and the DNA on the slide and make sure they are not unique to someone else. That there’s no mix-up.”
Goldfischer says that the entire process takes about five days. “We’ve never had a non-match,” he says. “In a positive test result you will see an elevated PSA or a problem with a rectal exam. If your test should have been positive, but the test came back negative, something would still show up on the next follow up tests.”
Filmmaker Chris Hennessy doesn’t live in the Hudson Valley, but understands the importance of a right reading.
“I’ve learned that reading the biopsy is not an exact science,” he says. “The slides are what they are, but the person reading the slides and making the diagnoses may not be seeing or reading the results as another is.”
Hennessy’s biopsy was in May 2009. The doctors told him that his Gleason Grading system scores included many 9s, 8s and some 7s. The Gleason Gradingsystem is used to help evaluate the prognosis of men with prostate cancer. Cancers with a higher score are more aggressive and have a worse prognosis. “A couple weeks later, I had another hospital read the biopsy, and they all came back as Gleason scores of 7s,” says Hennessy, who is making a film of his experiences during his prostate cancer journey (visit his website www.touchedbyhannah.com for more information). “The doctor told me the No. 7s were not something to dance around and celebrate, but the reading is correct, it could mean the difference between life and death.”
This year, according to the National Cancer Institute, there will be an estimated 233,000 cases of prostate cancer diagnosed in the United States and 29,480 deaths.
If you have any questions about a medical mistake that has happened to you or a loved one, please feel free to contact the Law Offices of Michael S. Lamonsoff, PPLC.
Contact us by e-mail or call us at 212-962-1020 (toll free at 877-MSL-4LAW or 877-675-4529) to schedule a free initial consultation.