Indicted on charges related to 124 genetic cancer tests performed between 2013 and 2014, former Hershey Medical Center Research Technologist Floyd Benko pleads guilty to charges with a maximum sentence of up to five years in prison
Wake up calls don’t come any clearer. False reporting of clinical laboratory test results will not be tolerated and anyone engaged in it will pay hefty fines and go to jail. Medical laboratories and anatomic pathology groups were put on notice when in July, nearly two years after he was indicted for healthcare fraud, Floyd Benko, of Palmyra, Penn., pled guilty in State District Court to charges of making false statements.
Benko, a 60-year old former research technologist at the Hershey Medical Center (HMC) in Hershey, Penn., surrendered to authorities on July 31, 2015, according a 2015 news release from The United States Attorney’s Office for the Middle District of Pennsylvania. The charges centered on 124 genetic diagnostic tests he performed at HMC between 2013 and 2014. Repeat testing conducted at HMC’s expense resulted in 60 tests results returned from two outside laboratories that differed from Benko’s reported results. No civil charges related to those 60 patients have been filed at the time of writing. And while sentencing is not yet scheduled, part of Benko’s plea requires restitution to HMC in the amount of approximately $70,000.
According to a Department of Justice (DOJ) press release, “The maximum penalty for false statements in healthcare matters is five years’ imprisonment, a term of supervised release following imprisonment, and a fine.” Coverage of the case at PennLive adds, “That agreement also cites a stipulation between the prosecution and defense that the advisory guidelines for Benko’s case call for a prison term of up to one and a half years.”
A Brief History of the Case and Charges
Details in media coverage regarding the case remain scant. However, case filings highlight a few details that help to establish a timeline of the alleged wrongdoing.
According to filings found at Leagle, charges stem around results to a range of genetic diagnostics, including:
· Epidermal Growth Factor Receptor (EGFR);
· KRAS gene mutation; and,
· BRAF gene mutation tests.
Documents show Benko had more than two decades of experience working with HMC. He also helped to define standard operating procedures (SOPs) for the tests in question. This is key to the case as charges stem from failing to follow the SOPs he helped to put in place.
Between April 9, 2013, and November 10, 2014, Benko performed 124 of these procedures for HMC. The SOPs required use of a NanoDrop 2000 spectrophotometer and preservation of tissue samples and specimens involved in all procedures.
Court filings note, “In late 2013, a treating physician observed that a patient’s HMC test results were at odds with the patient’s clinical profile. Defendant had performed the particular test in question. The treating physician ordered the same test from an outside laboratory, which reached a different result than the results reached by Defendant on the same patient’s tissue.”
When these results were brought to the attention of HMS supervisors, they requested Benko repeat the test. His results, again, differed from those of outside laboratories. This led to a request to access the tissues used in the test. Benko could not provide them.
Upon further investigation, the samples for 124 tests were missing. Court filings note, “[Benko] had no explanation for the missing DNA and tissue slides at that time.” HMS ordered retests for the tests with outside laboratories at a loss of more than $102,000. The 2015 DOJ press release breaks down these losses further, separating the figure into “$65,000 for outside laboratory testing and $37,406 for assay refunds.”
Of the 124 results, 60 returned discordant with Benko’s findings. This led to Benko sending two letters to HMS supervisors—one in April 2014 and another in October 2014, following his termination—attempting to explain the discordant results. Neither mentioned the NanoDrop 2000 spectrophotometer or provided reasons for failing to preserve tissue samples.
In July 2015, a federal grand jury returned an indictment on three counts related to the questioned testing. The court filing lists charges as follows:
“In Count I, the indictment charges Defendant with healthcare fraud in violation of 18 U.S.C. § 1347. According to the indictment, Defendant defrauded HMC in connection with the delivery of healthcare services by:
1. Failing to use the NanoDrop 2000 spectrophotometer in conducting the assays;
2. Failing to preserve the leftover patient tissue samples;
3. Failing to disclose his actions to his supervising physician or HMC management; and,
4. By providing false statements about the manner in which he performed the tests.
Counts II and III charge Defendant with making false statements to HMC. Counts II and III are predicated on the letters Defendant wrote to HMC in April and October of 2014.”
Critical Considerations for Medical Laboratories
The criminal charges levied at Benko directly result from his work in a clinical laboratory. And while the guilty plea does not include the healthcare fraud charge, it highlights the potential criminal liability risks pathology and medical laboratory workers face when tests prove inaccurate due to user error.
Because of discordant test results, an individual worker of a clinical laboratory was held liable for damages. Ensuring protocol adherence and accuracy of test results—particularly as new genetic assays and diagnostics reach laboratory test menus—can help to identify potential problems before they become a legal concern.
Maintaining rigorous records and following protocols for required samples and specimens also can help to establish evidence and resolve concerns should they arise.