CEO SUMMARY: After going public with the discovery that it had reported false positive lab test results for Chlamydia to eight female patients, Mid America Clinical Laboratories (MACL) found itself the subject of stories broadcast by a local television news program. The news coverage featured an interview with one irate patient who said she had assumed her husband had cheated on her and had “kicked him out of the house.” This episode is a reminder that all clinical laboratories should have policies in place to address errors in laboratory testing.
IN INDIANAPOLIS LAST MONTH, erroneous laboratory test results for Chlamydia made the television news. For at least one patient, the false positive results of her Chlamydia test had caused unexpected stress to her marriage.
This disclosure of inaccurate laboratory test results—and the local media coverage it generated—is a reminder to all pathologists and clinical laboratory administrators of how lab errors can disrupt the lives of patients. This episode also demonstrates how news outlets quickly pick up a story about how “the laboratory got it wrong, and patients’ lives were negatively affected.”
It was Mid America Clinical Laboratories (MACL) of Indianapolis, Indiana, which admitted to the lab test errors. On April 4, 2011, MACL issued a public statement acknowledging that it had issued false positive Chlamydia test reports. Television station 6News reported that MACL believed eight patients got the false positive results. MACL explained the source of the errors and the corrective steps it was taking to prevent similar errors in the future.
In this statement, MACL stated that “An error occurred in our molecular testing for Chlamydia that we sincerely regret. All affected patients are being credited for testing completed and have been offered reimbursement for necessary examinations with their physicians and any medications prescribed as a result of the discrepant results.”
This statement was signed by Nancy Bray Boggs, Vice President, Human Resources & Corporate Communications. In response to inquiries from THE DARK REPORT, Boggs provided a detailed statement just as this issue went to press. That statement will be printed in full in the next issue of THE DARK REPORT.
Trouble in one Marriage
False positive results for Chlamydia caused major problems for one patient in her marriage. 6News reporter Rafael Sanchez interviewed Tracey Sturm. “I assumed that my husband had cheated on me,” said Sturm during an interview, which is available here. “I kicked him out of the house. He insisted he didn’t do anything.”
A second test confirmed that Sturm did not have Chlamydia. Otherwise, she may have sought a divorce from her husband of 18 years, she told Sanchez.
The MACL statement disclosed that the error occurred because the eight samples were cross-contaminated as a result of the strand displacement amplification (SDA) method that the lab’s analyzer uses when testing samples for Chlamydia.
MACL’s Corrective Actions
Bray Boggs told 6News that: 1) the lab was cleaned since the false positives were reported; 2) the parts of the machine that caused the contamination were replaced; and, 3) the equipment is now housed in a room in the laboratory where the air flow can be better contained.
In Sanchez’ video report, the machine appears to be a BD Viper. As of press time, BD’s public communications office had not returned calls from THE DARK REPORT requesting comments.
The publicity surrounding the public disclosure of erroneous laboratory test results reported to patients is a reminder to all pathologists and lab administrators that the quality bar is rising. Both physicians and patients expect near perfection from their lab testing providers.
After discovering it had reported false positive results for Chlamydia tests involving eight patients, Mid America Clinical Laboratories appears to have complied with federal and state lab regulations governing this type of incident. On the following pages, THE DARK REPORT offers some additional insights about how labs should respond to these types of events.
Mid America Clinical Labs Explained Source of Lab Test Errors and Corrections
IN ITS STATEMENT DATED APRIL 4, 2011, Mid America Clinical Laboratories (MACL) discussed its actions once it had detected errors in its Chlamydia testing program.
“MACL uses a very complex and sensitive process when testing for Chlamydia,” wrote Nancy Bray Boggs, Vice President, Human Resources & Corporate Communications. “This molecular testing uses strand displacement amplification (SDA), which is FDA cleared. Small sequences of DNA unique to Chlamydia are located by molecular means within the gene sequences of the infectious organism within the patient sample and are replicated exponentially so they can be seen by the instrument, and therefore diagnosed as such. This SDA method is extremely sensitive and specific for the identification of Chlamydia.
“The amplicon (the amplified copies of the chlamydia DNA achieved through the SDA process) can escape into the testing environment resulting in cross-contamination of otherwise negative patient samples,” the statement continued. “That is what happened in this case. When our negative quality control tested positive, we immediately stopped testing, notified physicians involved, notified the Indiana State Department of Health, and sent original, affected specimens to another laboratory for testing. As well, all subsequent test orders were sent out for testing.
“At the same time, because the source of contamination seemed to be within the instrument, we took all necessary steps to clean and replace parts in the instrument,” the statement continued. “However, it was found that there was additional cross-contamination in the environment that resulted in additional cleaning followed by subsequent quality control checks. Testing resumed once that had been completed.
“A root cause analysis has been performed and we modified some processes to minimize this from happening in the future,” concluded Bray Boggs in the statement.