Last month there was a news article on Bloomberg.com about a test results follow up error that was an absolute nightmare for a patient and her family, a physician, and a laboratory (Langreth 2012).
In the unfortunate case presented in the article, a woman with a history of breast cancer was prepared to undergo bilateral prophylactic mastectomy if she had the BRCA1 or BRCA2 breast cancer gene mutations that predispose to breast and ovarian cancer. That would also have potential implications for other family members who might also have these gene mutations and be at risk for cancer. After some difficulties getting insurance authorization for the test to be done she finally underwent the testing. Her physician told her the test was negative and the patient was quite relieved. However, almost 3 years later she found another breast lump and turned out to have advanced breast cancer. She underwent bilateral mastectomies and removal of her uterus and ovaries and received chemotherapy. When her new oncologist recommended genetic counseling, the genetic counselor called for the results of the prior testing and, to the surprise of the patient, the main test done 3 years earlier had in fact been “positive for a deleterious mutation”.
Here is where the details get cloudy, perhaps because the article could not get complete information from the original physician and the laboratory, both of whom seemed reluctant to provide full information perhaps out of concern about potential litigation. But it appears that there were actually two types of testing done by the lab. The first test looking for “large rearrangements”, which account for 6-9% of the BRCA mutations, was reported as saying “no mutations detected”. The second test, which detects mutations that account for an 84% risk of breast cancer and 27% risk of ovarian cancer, was “positive for deleterious mutation”. The 2 tests were apparently sent to the physician approximately 2 weeks apart. The article specifies the report of the positive test was sent via Federal Express and does not specify how the negative test result, which apparently was the one sent later, was delivered. The only response given by the physician to the reporter in the article was that he felt it was quite likely he had never seen the report with the positive result. The article implies that he had circled and initialed the “negative” report but no sheets with his initials on a “positive” report were found (note that the physician only provided a copy of the “negative” report for the article). The lab did note they had contacted the physician’s office about a week after the second report was sent and left a voice message for the RN in the office to “clarify test results”. And to complicate matters, it appears that the second test (the “negative” one) may not have even been ordered but rather added on by the lab as a free test.
The article included commentary from Ellen Matloff of the Yale Cancer Center who has coauthored several excellent articles on adverse events associated with cancer genetic testing (see Brierly 2012). Those adverse events include wrong tests being ordered, test results being misinterpreted, unnecessary costly tests being done, inadequate genetic counseling, and ethical issues. They discuss the factors contributing to these adverse events, focusing on inadequate physician training in this field, time pressures, case complexity, and poor communication. They also discuss some of the marketing practices promoting use of genetic testing.
Genetic testing issues aside, this is one of those cases where it would be extremely useful to publish a root cause analysis of the event(s). While there would undoubtedly be lots of finger pointing and blaming during any legal proceedings, it is very clear that there are problems with the system here. And while we concur with the general theme of the article that there is a widespread lack of physician understanding of genetic testing (we actually think that all but the simplest of genetic tests should require formal genetic counseling and ordering by someone who has credible credentials to do so), this very unfortunate case raises multiple issues about the system for test tracking. More importantly, we’re not sure that this error could not occur even in those practices where we have implemented what we think are best practices for test tracking to ensure patient safety.
The case uncovers a fundamental flaw in most test tracking systems, whether they are electronic or paper-based. The flaw is in how we handle test results that entail more than one report. This case is similar in many regards to the lab error we discussed in our March 6, 2012 Patient Safety Tip of the Week ““Lab” Error”. That case was from the February 2012 issue of AHRQ Web M&M (Mohta 2012) that illustrates an error in a situation that likely occurs frequently and may be underappreciated: the amended lab report. In that case a young pregnant woman was admitted to a hospital with hypertension and protein on urinary dipstick testing. A 24-hour urine for protein was initially (erroneously) reported as negative for significant proteinuria. A resident was preparing the patient for discharge when the attending physician fortunately double-checked the result. In fact, the initial erroneous report had been amended and did, in fact, show significant proteinuria. That confirmed a diagnosis of pre-eclampsia and significantly altered the clinical management of the patient.
In both cases it is likely that “closure” would have taken place in the clinician’s mind once receiving the “negative’ or “normal” result in a formal report that is not designated as an interim or preliminary report or an addendum. If you had a paper-based or electronic test tracking system or other sort of “tickler” you’d probably check that test off as “done” and it would disappear from you list (and from your mind).
In the cancer case, it is also not surprising that receipt of a second report stating “no mutations detected” (even after a first report stating that deleterious mutation were detected) might be misinterpreted to mean the patient did not have the dangerous gene mutations.
If one were doing a root cause anaylsis (RCA) on the case at hand two issues that would undoubtedly be addressed are (1) why were there 2 reports? and (2) why was there not direct communication with the physician?
Unless there is a compelling urgency to report such results immediately it makes sense to wait until all the related test results are available and can be reported in total. Having just one report would reduce the likelihood of overlooking or missing half of the relevant report. However, if it is clearly known that the “test” actually involves multiple tests then each individual test should be flagged in your test results tracking system so you know when some test results have not yet returned.
However, the second issue is even more important. Significant findings should require verbal notification or other form of MD notification that can confirm recipient acknowledgment of the result. The College of American Pathologists and Association of Directors of Anatomic and Surgical Pathology have issued a consensus statement about communication of urgent diagnoses and significant unexpected diagnoses in surgical pathology and cytopathology (Nakhleh 2012). While the genetic testing above is not technically in that realm, the principles should be the same. Essentially, they state that each organization should establish a policy for which test results that may significantly impact on patient care should be reported directly to physicians and what the time frame for that communication should be. They recommend communicating verbally and directly with physicians but note that other satisfactory methods of communication might be used. If the receiving physician were able to acknowledge, for example via secure email, that he has received and read the report and understands it, such might be an acceptable mode of communication. However, given the complexities of genetic testing as noted in the Brierly study one would think a direct verbal communication with the physician would be wisest.
And there should be a backup plan for circumstances where the physician is unavailable. They also note that the pathologist should document that communication in some fashion.
We think the same should apply to laboratories doing genetic testing. And we would bet that BRCA1 and BRCA2 gene test results would be near the top of any list developed where such communication should be required.
We hope you will read the Bloomberg.com article (Langreth 2012) because we can’t describe the human impact on the patient and her family like they do in the article. No one in healthcare wants that to happen.
But the real lesson here is that we know certain errors are predictable. It is very predictable that reports sent to an office might never reach the office, might not be seen by the appropriate provider, might be put in the “inbox” and stick to another report, might be misfiled, etc. When the report is one that has potential life and death implications or other significant health implications, it is imperative that communications systems be reliable in ensuring the provider that needs to know the result actually knows the result.
Some of our other columns on errors related to laboratory studies:
See also our other columns on communicating significant results:
Langreth R. Fumbled DNA Tests Mean Peril for Breast-Cancer Patients. Bloomberg.com September 10, 2012
Brierley KL, Blouch E, Cogswell, W, et al. Adverse Events in Cancer Genetic Testing: Medical, Ethical, Legal, and Financial Implications. Cancer Journal 2012; 18(4): 303-309, July/August 2012
Mohta VJ. Amended Lab Results: Communication Slip. AHRQ Web M&M February 2012
Nakhleh RE, Myers JL, Allen TC, et al. Consensus Statement on Effective Communication of Urgent Diagnoses and Significant, Unexpected Diagnoses in Surgical Pathology and Cytopathology From the College of American Pathologists and Association of Directors of Anatomic and Surgical Pathology. Arch Pathol Lab Med. 2012; 136: 148–154