CEO SUMMARY: Prevention of diagnostic testing errors is getting more attention by both physicians and pathology labs because patients are less tolerant of potentially life-changing errors. Strand Diagnostics’ Know Error system is designed to reduce or eliminate errors involving tissue specimen misidentification. In this first part of our two-part series, we provide information about the diagnostic or “prospective” use of this system by physicians. Part two addresses how pathology labs in a QA/QC or “retrospective” manner accurately identify a misidentified specimen and rectify suspected misidentification.
FIRST OF TWO PARTS
IT’S EVERY ANATOMIC PATHOLOGY LAB’S WORST NIGHTMARE. Tissue specimens from two patients get mixed up somewhere between the operating room and the pathology laboratory.
Days later, a cancer-free patient is told she has breast cancer. In the belief that the malignancy will metastasize, this woman (actually free of cancer) takes steps to have both her breasts removed. Meanwhile, a patient with cancer is mistakenly told she is cancer free, thus preventing her from getting immediate treatment for her cancer.
Such errors may become national news because of the compelling human issues involved in these situations. At the same time, consumers expect a higher standard of care and are surprised when “the system” fails individual patients in such a dramatic and life-altering fashion.
For the anatomic pathology laboratory where the mistake occurred, the consequences are significant. Besides medical malpractice liability, employees and pathologists involved in these cases of major medical errors often have emotional reactions which affect their confidence and their productivity in performing daily duties.
For many reasons, today’s patient has an expectation of “zero errors,” particularly for major medical mistakes that are life-changing. Yet most pathology laboratories operate with the management mindset and workflow practices developed three or four decades ago.
In recent years, companies have begun to enter the marketplace with services and solutions designed to help reduce the instances of pathology specimen misidentification or contamination. At least two companies currently offer services and systems intended to improve the accuracy and reliability of specimen identification and specimen tracking. One is Ventana Medical Systems, which offers products marketed specifically to pathology laboratories that are designed to eliminate errors.
The second company is Strand Diagnostics of Indianapolis, Indiana. A noteworthy aspect of its “Know Error” service is that it has not yet been advertised to pathology laboratories. Rather, Strand’s marketing campaign targets office-based physicians who perform biopsies and send the tissues to anatomic pathology labs for evaluation.
Problems of Misidentification
“The Know Error system addresses a significant problem with the diagnostic testing cycle for cancer—undetected sample contaminations and misidentifications,” stated C. Michael Harmon, Vice President, Marketing & Communications for Strand Diagnostics. “Samples can be misidentified or contaminated. This can occur in the surgical suite and it can happen in the pathology laboratory.
“Our system ensures that when such errors happen—as they inevitably do—no patient is harmed!” he stated. “This is how Know Error is a prospective system that helps to prevent errors.”
What will be of interest to pathologists and their practice managers is that, since the launch of Know Error in 2009, a retrospective use of the system has been discovered by a growing number of pathology groups. According to Harmon, the retrospective use was unplanned and unexpected, but meets an important need for pathology labs when errors in tissue specimen identification are discovered.
“This is the QA/QC, or retrospective, use of our Know Error system,” he said. “We regularly get calls from pathology labs that have discovered a misidentification problem or a contamination problem involving the specimens of one or more patients.
“They ask us to help them make an accurate match of the misidentified specimen to the correct patient,” he continued. “We can do this with a very high level of confidence.
“In this retrospective application, use of Know Error helps prevent a patient from getting a wrong diagnosis,” Harmon added. “It goes without saying that the resulting benefits to both the patient and the pathology laboratory are immense. The patient gets the right diagnosis and the laboratory has prevented an error that could have resulted in patient harm and considerable expense from malpractice litigation.”
The retrospective use of Know Error will be the subject of part two in THE DARK REPORT’S coverage of this market development. It is important to keep in mind that the prospective use is a specific way to minimize and prevent the sample misidentification and contamination problems inherent in the diagnostic testing cycle for cancer.
“At the launch of this service in 2009, we focused our sales and marketing efforts toward office-based physicians for several reasons,” he said. “First, they perform the biopsies and collect the specimens and this is the first place in the process where a misidentification or contamination can occur.
“Second, physicians who treat patients understand that errors of mislabeling and misidentification of laboratory specimens happen with regularity—even if it is a sta- tistically low number,” continued Harmon. “Knowing this basic fact, many physicians are motivated to implement a system with protocols and a ‘chain of custody’ that pre- vents one of their patients from receiving an inaccurate pathology diagnosis because of a misidentified specimen.”
Use of DNA And Bar Codes
The system Strand Diagnostics developed combines DNA testing with the use of bar codes and a chain-of-custody protocol that is similar to that used in forensic testing.
“Participating physicians using the Know Error system are sent a biopsy kit to collect a buccal swab when they do a biopsy of any patient,” explained Harmon. “We instruct them to send the buccal swab to us and to send the biopsy specimens to their anatomic pathology lab.
“The benefit of having the swab and the tissue go to different sites improves the control factor,” he continued. “When the biopsy samples get to the lab, the lab runs its tests.
“If cancer is detected, the lab will send us some of the patient’s tissue,” said Harmon. “We match that tissue against the swab. If the DNA profiles of the swab and tissues do not match, we take a ‘DNA timeout’ to resolve the issue before the patient gets treated.
“It’s important to understand that, in this context, Know Error’s DNA testing is ordered only when a lab makes a positive cancer diagnosis,” he said. “Physicians use the Know Error system to increase patient safety and diagnostic accuracy.
Prospective Use by Doctors
“Initially, we marketed this service primarily to urologists because of the relatively high rates of positive cancer specimens they handle,” stated Harmon. “The national average is about 30% to 35%, which is among the highest rate of positives of all specialties.
“A growing number of radiologists and breast surgeons also regularly use our service,” he added. “These specialties all tend to have more positive cancer diagnoses for the same number of biopsies, compared to other medical specialties.
“Among breast biopsies, the rate of positive results is about 18% to 25%,” he noted. “The detection rate is lower but the screening rate is higher for breast cancer than it is for prostate cancer.
“By contrast, the rates of positive diagnoses for gastroenterologists and dermatologists are significantly lower,” continued Harmon. “Only about 1% of skin biopsies are positive for melanoma, for example. As a result, there is not as strong a demand for our system by these medical specialties.”
In this context, Harmon was clear that it is office-based physicians and ultimately patients who are Know Error’s customers. “As part of the test requisition, when the physician orders the DNA test, the patient’s insurance is billed for our services,” he added. “However, that physician needs the cooperation of his or her pathology laboratory when using Know Error prospectively to avoid specimen misidentification errors.
“Once a physician adopts the system, we contact that physician’s pathology laboratory and explain that one of its ordering physicians is using Know Error as a proactive step to reduce errors,” stated Harmon. “We explain how the system works and what the pathology laboratory needs to do to support the program. For the most part, these pathology laboratories are eager to please their customers and they see that our process is not difficult.
“We also see a wide range of specimen types, given our mix of customers,” he stated. “As you would expect, specimen referrals from urologists, radiologists, and breast surgeons run the full gamut. In this sense, each case can be unique.
“The path a tissue specimen follows from when it is collected until the report is issued involves a long series of complicated process steps,” noted Harmon. “At any step, something can go wrong.
“Pathologists know that the process of collecting and evaluating a biopsy specimen to make a cancer diagnosis involves nearly 20 steps and several medical professionals working in different locations,” explained Harmon. “Such a complex process executed on a large scale increases the risk of errors.
“These errors can involve patient misidentification, specimen transposition, or foreign cell contamination—all known to occur in clinical or anatomical pathology laboratories,” observed Harmon. “Should these errors go undetected, they can lead to misdiagnoses and adverse patient outcomes.
“Currently, the laboratory medicine profession recognizes that there is a recurring rate of errors—even if statistically quite low—in the handling and processing of specimens,” he continued. “Further it is acknowledged that these types of errors have the potential to cause patient harm if not detected and if not corrected in a timely fashion.
Matching Patient’s DNA
“The contribution of Strand Diagnostics is to introduce additional steps in the protocol,” he noted. “The protocol we developed—that of having a cheek swab come to us when a biopsy is performed, then testing the patient’s DNA on the swab against the DNA from the cancerous biopsy tissue— provides an important guarantee to the referring physician and her or his pathology laboratory that there should never be an adverse outcome as a result of a misidentification,” Harmon asserted.
“The positive consequences of preventing just one of these serious errors is that a patient’s needless pain and suffering has been avoided,” he said. “On top of that, both the physician and the pathology laboratory avoid the increased liability and costs that come from diagnostic misidentification errors.”
Prospective & Retrospective
In its original design, Know Error was intended to be a prospective system that would serve to reduce or prevent misidentification and contamination errors involving tissue specimens. However, it did not take long before pathology laboratories were contacting Strand Diagnostics to engage the Know Error system in a retrospective manner, to support quality control/quality assurance (QC/QA) after an error with a tissue specimen had been identified.
“We regularly work with pathology groups and hospitals who, through the course of preparing the sample for analysis, suspect that a tissue specimen misidentification or contamination error has occurred,” he noted. “In these situations, Know Error is used retrospectively as part of a lab’s QA/QC protocol.
“One retrospective use is to properly match a misidentified tissue specimen to the correct patient before a wrong report would be issued,” Harmon explained. “In this example, the mistake is caught and corrected before it caused possible patient harm.
“Another retrospective use of Know Error is after a patient got the wrong diag- nosis and inappropriate treatment,” he continued. “In these types of cases, the goal of the hospital and pathology laboratory is to accurately understand and match the misidentified specimens.
“We know there is interest among risk managers from large self-insured healthcare provider organizations for the work that we do,” Harmon added. “Risk managers understand the positive implications of a system that reduces liability risk for pathologists and for all providers involved in handling patient biopsies. In addition to hospital and health system risk managers, pathologists also are interested in our Know Error system, even though we do not yet market to them.”
How pathology laboratories are using the Know Error system retrospectively will the focus of part two of this two-part series. Strand Diagnostics reports that this demand from pathology groups was unexpected and not part of its original business plan. Currently Strand Diagnostics is involved in as many as 20 cases per month where a pathology group suspects a misidentified tissue specimen and wants to use Know Error to correctly associate that specimen with the right patient.
Long Island Medical Group’s Research Shows How System Reduced Specimen ID Errors
HOW SUCCESSFUL IS THE KNOW ERROR SYSTEM at preventing misidentification and specimen contamination errors in a pathology laboratory? That was the question Integrated Medical Professionals, PLLC, of Melville, New York, sought to answer last year.
IMP is a urology practice of more than 100 physicians who practice in 50 locations throughout Long Island in New York state. It operates an in-practice histology laboratory. Last spring, the pathologists at IMP presented a poster on this topic at the United States and Canadian Academy of Pathology’s annual meeting in Vancouver, British Columbia.
“Despite the utilization of labeling systems, the opportunity for diagnostic mistakes due to occult specimen provenance complications persists,” the poster said. “Our aim is to evaluate and compare our novel system with that of our reference laboratories using the Know Error system’s DNA Specimen Provenance Assignment Assay (DSPA).”
Know Error is a system developed by Strand Diagnostics in Indianapolis, Indiana, that uses bar coded test kits and DNA matching to confirm identification of surgical biopsy samples for physician practices and pathology labs.
“We compared our unique process of specimen ownership versus the process at our reference labs,” the poster said. “In a nine month period, 90 urologists swabbed 6,913 patients [after a biopsy specimen had been collected]. Of those, 2,174 patients had adenocarcinoma. Although initially there were 11 cores reported as being mismatched, these were resolved with resubmission of adequate samples. Three errors occurred at IMP Pathology, and all were contamination errors.
“For comparison, eight errors occurred at IMP’s reference labs, including five that contained DNA from different persons (meaning they were wrong patient errors), and three were contamination errors,” the poster said.
When IMP compared the results of its IMP Pathology Laboratory Quality System to the results of the outside reference laboratories, IMP concluded that it had fewer total non-match [specimen identification] errors compared with the reference labs and that IMP had only contamination errors that were all resolved with resubmission. It had none of the most troubling errors involving misidentified patients, the poster said.
“After extensive root cause analysis, the wrong patient errors at the outside reference laboratories were determined to be due to submission of the wrong tissue for subsequent DNA analysis, a common, but potentially devastating error in anatomic pathology,” the poster said. “This error is eliminated using the IMP system.”
After Confirmation of Accurate Identification of the Patient Specimen, Know Error Files Claim
THERE ARE SIMPLE WORKFLOW, BILLING, and reimbursement requirements for office-based physicians using the Know Error system designed by Strand Diagnostics to reduce errors from misidentified tissue specimens.
“Physicians using Know Error do not bill for the Know Error service,” stated C. Michael Harmon, Vice President of Marketing and Communications at Strand Diagnostics. “When they harvest biopsies, they use the collection kits we provide to them.
“Our kits include the swabs and bottles for the tissue samples,” he said. “After collecting the cheek swab and doing the biopsy, the doctor sends the buccal swab to us. He or she then sends the tissue specimen to the pathology laboratory according to customary practice.
“Obviously collection of the biopsy is a billable event for the surgeon because he or she is doing a biopsy as usual and getting the buccal swab,” he explained. “But we are not aware of any additional fee for collecting the cheek swab from the patient.”
“Next, the physician refers the biopsy to his or her pathology laboratory,” he continued. “Once the lab runs the test and has a positive diagnosis for cancer, the lab does one thing different before it sends the report to the referring doctor.
“In this situation, the Know Error protocol says the lab has a standing order to send an additional sample to Strand Diagnostics,” said Harmon. “The lab gets this additional sample from the original block of patient biopsy tissue that it keeps for its own sample management purposes. We are not aware of whether the laboratory can get an additional fee for sending this sample to Strand Diagnostics.
“We use this additional sample for our confirmatory testing,” added Harmon. “We run the DNA Specimen Provenance Assignment (DSPA) test on the tissue sample they send us and on the cheek swab. That’s how we can confirm the identity of the patient’s sample.
“That DSPA test is a billable event and Know Error will bill the commercial or government insurer using existing molecular diagnostic CPT codes,” he said. “Average reimbursement is about $350 per test.
“To date, there have been very few occasions where insurers declined to pay this claim,” he recalled. “Should that happen, the patient is responsible for a co-pay and a deductible. We do not balance bill any patients for out-of-network disallowances.
“To summarize, there is no charge to the laboratory to be involved in this work,” con- cluded Harmon. “All the lab does is send us a sample of the patient’s tissue from storage whenever there is a positive diagnosis. Strand Diagnostics does the necessary DNA testing to confirm the accurate identification of that patient’s tissue and it will file a claim for that service.”