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Hershey-Medical-CenterIt what may be a unique first for the clinical laboratory industry, a medical technologist in Pennsylvania has been found guilty of a criminal felony for failing to perform certain cancer genetic tests according to approved protocols. The judge has sentenced the medical technologist to 15 months in prison and repayment of almost $70,000 in restitution.

Dark Daily reported on earlier developments in this case in 2017. Medical technologist Floyd Benko was indicted in 2015 after pleading guilty to false statement charges stemming from his work with genetic testing at Hershey Medical Center (HMC) between November 2014 and April 2015. Now, Benko has been sentenced to nearly 15 months in prison after pleading guilty to false statement charges.

US Middle District Judge Yvette Kane sentenced Benko to 15 months in prison with three years of supervised release following his prison term. He must also make restitution to HMC in the amount of $69,742 related to retesting of the gene mutation tests he previously performed in which the results were found to be inaccurate.

The sentence required Benko to report to the Pennsylvania Bureau of Prisons on January 22, 2018.

Failure to Follow Protocols Leads to Faulty Results and Eventual Sentencing

The charges levied against Benko relate to DNA gene mutation tests performed by him on behalf of HMC for 124 advanced-stage cancer patients. According to a Department of Justice press release, the genetic testing included:

  • Epidermal Growth Factor Receptor (EGFR);
  • KRAS gene mutation; and
  • BRAF gene mutation assays.

“Benko failed to perform the assays in the manner called for by Hershey’s standard operating procedures,” the press release states. “Subsequent retesting of the patients during summer 2014, revealed that 60 of the 124 patients had assay results discordant with results obtained by two outside medical laboratories.”

Unusual Application of Federal Fraud Statute

Dark Daily’s previous coverage provides a detailed timeline of events leading up to Benko’s guilty plea.

Court filings state that in late 2013, a treating physician at HMC noted discordant results for tests when compared to a patient’s clinical profile. The physician resubmitted the test to an outside lab and received results that differed from those of Benko’s test.

This led to a request from HMC supervisors for Benko to repeat the test. Again, results differed from the outside laboratory. When supervisors asked for access to the tissue samples used for the test, Benko could not provide them.

Standard operating procedures (SOPs) for the tests in question—procedures Benko himself helped to create in conjunction with HMC—required preservation of all tissue samples. They also required the use of a Thermo Scientific NanoDrop 2000 spectrophotometer—a piece of equipment that Benko did not acknowledge using.

With Benko unable to provide samples, HMC triggered an FBI investigation into testing practices by Benko. The investigation yielded 125 tests for which samples were not preserved. Repeat testing by two outside medical laboratories—at HMC’s expense—resulted in 60 assay results returned that were discordant with Benko’s original findings.

Benko eventually resigned from HMC. He later attempted to explain the discordant results in two separate letters to HMC supervisors. However, in July 2015, a federal grand jury returned an indictment: one count of healthcare fraud and two counts of making false statements in healthcare matters to HMC.

Copies of court filings available at Leagle show that Benko initially disputed the charges using four primary arguments and requested case dismissal. These arguments were eventually denied by Kane. “In refusing to dismiss the charges against Benko, Kane rejected his arguments that his alleged actions don’t constitute a crime, especially since he didn’t profit financially,” noted PennLive. “The judge did, however, characterize the Benko case as an ‘unusual application of the federal healthcare fraud statute.’”

After denial of his dismissal, Benko entered a guilty plea to false statement charges in July 2017. Follow-up coverage from PennLive explained that Benko’s plea agreement included a stipulation that advised a sentence of up to 18 months—of which he received 15 months. At the time of sentencing, the final charge appears to be one count of making false statements.

Establishing Protocols and Ensuring Accuracy in Medical Laboratory Testing

Anatomic pathology and medical laboratory testing is an increasingly important part of the modern healthcare system. Both value-based care models and personalized medicine rely on lab results to help improve outcomes and tailor treatments to the individual patient profile.

By failing to follow SOPs when performing these clinical laboratory tests, Benko potentially jeopardized the treatment outcomes and health of more than 100 patients and also created liability concerns for the laboratory in which he was employed.

As highlighted by Benko’s sentence, the impact from this case was not limited to the lives of more than 100 patients. It also affected both the reputation of HMC and their financials—requiring nearly $70,000 in additional spending for the flawed assays—and to confirm the results of suspect tests performed by Benko. And, this does not account for the time and monetary costs related to the investigation and prosecution of the case, or public relations work surrounding the case.

As test volumes continue to increase and lab liability continues to take the spotlight, it is essential that clinical laboratories, anatomical pathology groups, and other diagnostic service providers maintain effective protocols and procedures to ensure the accuracy of test results. And they must establish comprehensive documentation and compliance programs that create accountability and highlight concerns quickly to ensure both patient and laboratory safety.

Source: Dark Daily

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CMLF News Issue #7
27th January 2016