Houston newspaper breaks story about failure of many medical laboratories to report certain test results to public health laboratories, thus delaying investigations of disease outbreaks
Once again, problems with the existing system of medical laboratory testing made national news. This time, the key players were a maker of ice cream, clinical laboratories, and public health laboratories.
It was a Houston newspaper that first reported a pattern of failures in how clinical laboratories and public health laboratories communicate as clinical labs identify patients who tested positive for listeriosis, a bacterial infection most commonly caused by Listeria monocytogenes. These test results were associated with the recent listeriosis outbreak that was connected to Blue Bell ice cream.
Blue Bell, Listeria, and Lab Failures
On July 18, 2015, the Houston Chronicle reported on David Philip Shockley. He is a retirement community administrator who believes he contracted listeriosis by eating Blue Bell ice cream.
Shockley lived in Houston at the time. When he didn’t arrive at his job, co-workers went to check on him. He was found in his floor, with a high fever and shallow breathing. Shockley was taken to the hospital where doctors took blood samples, which were then sent to a clinical laboratory for testing. The results were positive for listeriosis.
Such a sample is called an isolate. When listeria is confirmed, most state laws require the medical laboratory to submit the isolate to the State Department of Health, where its DNA is extracted and recorded. The result is known as the bacteria’s DNA fingerprint. The Centers for Disease Control (CDC) manages a database of such fingerprints called PulseNet.
PulseNet is designed to help track foodborne illness. If, for example, several matching isolates from different parts of the country are recorded in PulseNet, linking them is far easier than it was before the system was implemented in 1996. However, if the isolates never make it to the State Department of Health, they will not be recorded in PulseNet and the illness will remain untracked.
That is exactly what happened in Shockley’s case. His doctors received the report confirming he had listeriosis, but the isolate never arrived in the Texas Department of State Health Services and so was not matched to the listeria samples that had been taken from Blue Bell Creameries.
The Chronicle reported that as many as 25% of listeria isolates identified by clinical laboratories in Texas were not recorded in the last five years. In some states, that number is as high as 40%.
State Laws Rarely Enforced
Thirty-one states have laws in place requiring isolates be submitted so that they can be recorded in PulseNet. However, based in its investigation the Chronicle discovered that these laws are rarely enforced and penalties are rarely imposed on labs, such as the delay in reporting by the medical laboratory that processed Shockley’s sample.
As part of an agreement with the Food and Drug Administration (FDA), the Association of Public Health Laboratories (APHL) convened a clinical isolates work group to study the issues surrounding the submission of isolates to PulseNet. According to an APHL report, “Since many states do not require the submission of foodborne isolates, public health must rely on the voluntary and timely submission of isolates from these laboratories.”
Newborn Screenings in the News
Just as PulseNet is supposed to help protect public health, the nation’s program of newborn screening is designed to protect babies. Also like PulseNet, the protection provided depends on many and varied entities each doing their part in a timely and efficient manner. Hospitals must collect the blood and make sure the sample gets to the testing lab. Then, the lab must perform the screening, and return the results to the hospital quickly and efficiently.
Despite the fact that guidelines were in place in 2013, and funding appropriated, there were still problems with the screening program (see “Medical Laboratories at Hospitals Urged to Improve Newborn Screening Procedures After Wisconsin Report Uncovers Shocking Testing Delays,” Dark Daily, February 19, 2014). The Milwaukee Wisconsin Journal Sentinel ran a series of articles highlighting the issues and how they impacted real people. Issues associated with compliance with state laws mandating newborn screening included:
• Some hospitals routinely batched samples, which meant delays getting those samples to the medical laboratory performing the screening tests.
• Some hospitals continued using the U.S. postal service rather than a courier service.
• Many labs collecting newborn screening samples were closed overnight, on the weekends, and during holidays, which sometimes led to additional delays in delivering the specimens to the laboratory performing newborn screening.
Media coverage about such widespread problems and non-compliance with newborn screening laws helped bring about the passage of the Newborn Screening Saves Lives Reauthorization Act. The public scrutiny also pushed states to begin releasing information about the newborn screening performance of individual hospitals.
Increased Visibility May Lead to Better Outcomes
Taken together, the news stories about the systemic problems and non-compliance with state laws involving newborn screening and the reporting of isolates provide a picture of how journalists are exploring mistakes within the medical laboratory testing system and bringing them to the attention of the public. Visibility and transparency are increasing. Whether such publicity results in more regulation,—as in the case of the newborn screening program—or additional scrutiny by industry associations, the effect is likely to be positive for public health, but perhaps uncomfortable for clinical laboratories and pathology groups.