CEO SUMMARY: When pathology labs discover instances of a misidentified or contaminated tissue specimen, there is a new service that allows them to retrospectively use DNA to properly match that specimen to the correct patient. In part two of our series, we look at how some pathology labs are using the Know Error service to catch these errors before the lab report is issued to physicians and patients.
SECOND OF TWO PARTS
MAYBE THE WORST THING that can happen to any anatomic pathology laboratory is to report the wrong patient results because a tissue specimen was either misidentified or contaminated—and the resulting error negatively affected the medical care delivered to the patient.
Indeed, it is a daily fact of life in anatomic pathology laboratories that errors do happen in the labeling and identification of tissue specimens. It is also recognized that contamination during processing is another way the integrity of a patient’s tissue specimen can be compromised.
Not only can there be harm to the patient who got the wrong diagnosis, but the pathology lab can face the considerable expense of malpractice claims. If news of the mistake is picked up by the media, there can be local and national news coverage of the event.
Recall the case of the unnecessary double mastectomy that happened in 2003 at United Hospital in Minneapolis, Minnesota. A pathologist at Hospital Pathology Associates misplaced slides and paperwork for different patients that were in the same folder. In this case, two patients each received the wrong test report. National news headlines resulted from the case.
In New York state, in 2007, a patient got inaccurate pathology test results due to a specimen labeling error in CBLPath’s histology lab. She chose to undergo a double mastectomy that proved to be unnecessary. National news accounts of this incident put CBLPath in a most unwelcome spotlight.
Now evolving technology and the new Know Error service offered by Strand Diagnostics of Indianapolis, Indiana, gives pathology laboratories a “retrospective” solution to resolve tissue identification errors or instances of specimen contamination. The technology can be a lifesaver if the error is detected within the lab before the patient report is issued. That helps the lab accurately report the right results for the right patient.
Use of the Know Errror system following the lab’s detection of a specimen identification or contamination error can also eliminate the need to recollect another tissue specimen from the patient. That alone can be a major benefit to both the pathology lab and the patient.
But in cases where an error goes undetected until after the patient report was issued, the Know Error system can also play a role. It can help the pathology lab accurately associate the misidentified specimens or contaminated specimens to the correct patients.
In a pathology laboratory, individual work processes in tissue processing may have a statistical rate of failure that is at the level of 3.5 sigma to 4.0 sigma (4.0 sigma is 6,210 defects per million events). Because patient safety can be compromised, these are unacceptably high rates of error.
Today’s patient has an expectation of “zero errors.” That puts every anatomic pathology laboratory under pressure to move the performance of its lab’s operation toward a 6 sigma level, which is just 3.4 defects per million events.
At the same time, following any significant medical error, pathology labs are equally under pressure to properly conduct a root cause analysis of each error, and then take the right corrective action to prevent such an error from occurring again. This is true whether the lab discovers the tissue identification error before the results are reported to the patient or whether it was after the report was issued that the error was discovered.
It is for these reasons that pathology lab- oratories are contacting Strand Diagnostics for the express purpose of using its “positive patient identification” technology and approach to resolve instances where patient specimens were misidentified. Before attempting to recollect tissue from those patients affected by such labeling errors, these pathology groups want to use the Know Error technology and service to establish a positive patient identification for the misidentified tissues.
“We originally designed Know Error to be a prospective diagnostic system that prevents, to the practicable degree possible, a patient’s tissue specimen from becoming misidentified,” stated C. Michael Harmon, Vice President, Marketing & Communications for Strand Diagnostics. “To date, we have marketed this service directly to specialty medical groups where tissue specimens are regularly collected. (See Part One, TDR, December 10, 2012.)
“When Know Error is used prospectively as intended, both the physician’s office that collected the tissue specimen and the pathology lab handling it can have a high degree of confidence that misidentification of specimens will not occur,” noted Harmon. “However, over the past 18 months, we have been surprised at how often pathology groups have contacted us to ask for help in resolving errors involving some tissue specimens.
“We see a steadily-growing demand by pathology groups to use Know Error in this retrospective way,” continued Harmon. “Thus, when the lab suspects that the tissue specimen is probably misidentified, our Know Error service provides a way to make a positive identification of that specimen. This avoids a potential medical error and means that the specimen originally collected can be used with confidence for diagnosis.
Specimen ID Errors
“Misidentification of pathology specimens is a problem,” observed Harmon. “We have a solution. Moreover, our solution covers the range of locations where the possibility of a specimen misidentification can occur. This includes all the stages—preanalytical, analytical, and postanalytical phases as well.
“Specimen misidentification errors can occur in physicians’ offices when specimens are being collected,” he said. “Other errors may occur in transport. But a large number of errors occur within the pathology lab and these include misidentification errors or contamination of specimens.
“When a lab finds an error that involves misidentification or contamination of a specimen, they can call us,” Harmon stated. “At that point, a lab director or pathologist suspects an error has occurred involving that specimen, but is unable to identify the patient accurately.
“The pathology lab knows it has a certain number of samples that it cannot identify properly and wants our help,” he continued. “At that point, it’s our job to identify the patients involved and match those patients to the specimens in question. And, of course, we want to solve the problem without inconveniencing the patients beyond collecting a cheek swab.
Cheek Swabs for Reference
“In most cases, for each patient involved, we collect a cheek swab to use as a reference sample,” noted Harmon. “The vast majority of the time, we can resolve a case without requiring a rebiopsy. By either using the slides used for diagnosis or having the lab retrieve the sample block and submit some tissue—along with a reference sample known to be from the patient—we can provide the critical information needed.
“From the buccal swabs, we next do a DNA analysis in order to match that DNA to the specimen the lab has on hand,” he said. “The DNA allows us to identify all specimens accurately.
“An error in identification of a specimen presents pathology labs with an interesting dilemma,” observed Harman. “Even if the error occurred outside the laboratory, the lab is nearly always responsible.
“If a switch was made in the physician’s office, the pathology lab would have no way to know that—but would still be responsible,” he said. “Your lab could be doing a great job, but that does not mean you’re getting properly-identified samples coming in your door.
“That is another interesting part of the challenge of preventing errors: A lab often does not know an error occurred until a physician calls after getting the lab report and treating the patient,” continued Harmon. “At that point, when a lab calls us for help, all we can do is start a retrospective analysis of the problem.”
The frequency of misidentified specimens in pathology laboratories is confirmed by the number of pathologists who contact Strand Diagnostics directly. In fact, a growing number of patients are also contacting Strand Diagnostics directly to find out about the Know Error service!
“Each month, we get calls from as many as 20 different pathology labs that are dealing with misidentified or contaminated specimens,” stated Harmon. “But of even greater interest is the fact that we get a similar number of inquiries from patients who question their pathology test results and want a verification. These patients find us on the Internet. Although most of our patient customers live here in the United States, we have had customers contact us from Japan, Dubai, and other countries.
Focus on Error Prevention
“Up to this point, we have talked about the retrospective use of the Know Error system, as it is used by either pathology labs tracking down errors or patients seeking a confirmation,” Harmon explained. “Those customers want a retrospective method to look back at their results.
“However, there is another element to the story of Know Error that is equally important,” he said. “There is interest among risk managers from large self-insured healthcare provider organizations for our work in this field.
“Risk managers understand the implications of the work we do on reducing liability risk for all providers involved in handling patient specimens, not just the pathologists,” Harmon added. “This is an interesting dimension to the market acceptance of our system.
“Last year, we were approached by a healthcare system with a case involving a misidentified tissue specimen,” he stated. “The patient had received the wrong diagnosis because of the error in specimen identification.
“The health system wanted us to help it accurately match the right specimen to the right patient as part of its root cause analysis and as part of the steps it needed to take in its resolution of the problem with the patient,” noted Harmon. “One consequence of this interaction is that this health system now uses the Know Error system in a prospective manner with every positive result to ensure that the right patient gets the correct lab test report.
“From a risk management standpoint— and to meet their internal goals for patient safety and improve patient outcomes—they consider the prospective use of DNA testing through Know Error to be appropriate,” he noted.
“These developments have been noticed by liability insurers,” added Harmon. “Based on the growing number of labs and physicians with positive experiences with the Know Error system and its role in helping prevent errors, we know there is interest among liability insurers to write policies that will provide a discount to physicians and labs that use this and other similar error-reduction protocols. If they do, the introduction of liability policies that carry lower premiums for use of these methods would be significant for both referring physicians and pathology labs.”
These developments are a sign to lab administrators and pathologists that more attention to error reduction and error detection will be necessary for labs to meet the higher bar for patient safety.
Pathology Groups Use DNA Testing to Link Misidentified Specimens with Right Patient
WHEN A PATHOLOGY LABORATORY discovers that a specimen has been misidentified or contaminated, it needs a reliable method to properly associate that specimen with the correct patient. In recent years, pathology groups have begun to turn to Strand Diagnostics and use its Know Error system to achieve positive patient identification.
“This is a retrospective use of Know Error,” stated C. Michael Harmon, Vice President of Marketing and Communications at Strand Diagnostics. “Simple steps are needed for us to assist the laboratory in matching a misidentified tissue specimen with the correct patient.
“The first step is to collect a cheek swab from the patient or patients who may be the source of the misidentified specimen,” he explained. “The buccal swab is sent to us. The lab also sends us a sample from the misidentified specimen.
“We run the DNA Specimen Provenance Assignment (DSPA) test on the tissue sample they send us and on the cheek swab,” noted Harmon. “That’s how we can confirm the identity of the patient’s sample.
“It goes without saying that this service can be a lifesaver for any pathology laboratory that discovers a misidentified or contaminated specimen,” he added. “The accurate and positive identification of the patient with his/her specimen means that the pathology lab has confidence that its diagnostic report is the right one for that patient.
However, there are instances where, because of a specimen misidentification or contamination error, the pathology laboratory has transmitted an erroneous report,” observed Harmon. “Only after treatment is the mistake discovered. This is when we may get a call from the pathology lab or even a patient with a request to help in the investigation and to provide a positive patient identification of the misidentified specimen. This is another retrospective use of Know Error.”
Two Studies Show the Value of DNA Testing to Reduce Diagnostic Errors in Pathology
TWO RECENT PEER-REVIEWED STUDIES show that the use of DNA testing to match biopsy samples can help to reduce common diagnostic errors.
John Pfeifer, M.D., Vice Chairman for Clinical Affairs, Pathology and Immunology at Washington University in St. Louis, Missouri, was the co-author on both studies. “The potential for misidentification of a patient’s biopsy results is a real concern in anatomic and clinical pathology with potentially devastating consequences,” he wrote. “While many physicians have long suspected that specimen provenance complications (SPCs) occur, these results provide the first estimate of their frequency.”
One study was published in the January issue of American Journal of Clinical Pathology. In this study, researchers showed that as many as 3.5% of patients initially diagnosed with cancer were subject to undetected specimen switches or contamination that could have compromised diagnosis accuracy.
In this study, researchers examined the rate of specimen provenance complications among 13,000 prostate biopsies processed in more than 50 pathology labs. For these biopsies, DNA Specimen Provenance Assignment (DSPA) testing was performed as part of routine clinical care.
The second study was published in Value in Health. In this study, researchers concluded that performing a simple DNA test to confirm the provenance of malignant tissue samples is a cost-effective way to improve patient safety and the accuracy of diagnostic testing.