Mar 5, 2018 | Compliance, Legal, and Malpractice, Laboratory Hiring & Human Resources, Laboratory News, Laboratory Pathology, Laboratory Testing
The indicted medical laboratory technician will also be required to pay back more than $69,000 to Hershey Medical Center
It 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:
“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.
Penn State Milton S. Hershey Medical Center (above) where in 2013 to 2014 Floyd Benko, a 60-year-old research technologist, improperly conducted 124 gene mutation clinical laboratory tests and then lied about it to cover up his lack of following standard operating procedures. (Photo copyright: PennLive/Paul Chaplin.)
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.
—Jon Stone
Related Information:
U.S. v. BENKO No. 1:15-cr-00159
Former Hershey Medical Center Worker Pleads Guilty to Lying About Cancer Testing Procedure
Judge Won’t Dismiss Charges That Hershey Med Tech Fudged Genetic Tests for Cancer Patients
Former Hershey Medical Center Research Technologist Sentenced for Making False Statements About Cancer Tests
Penn State University College of Medicine (COM); The Penn State Hershey Medical Center (PSHMC): Standard Operating Procedures (SOPs) Regarding Review and Management of Conflict of Interest
Hershey, Pennsylvania, Clinical Laboratory Technician Indicted in 2015 for Fraudulent Cancer Test Results Pleads Guilty to False Statement Charges
Oct 30, 2017 | Compliance, Legal, and Malpractice, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing
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.”
Penn State Milton S. Hershey Medical Center (above) where in 2013 to 2014 Floyd Benko, a 60-year-old research technologist, improperly conducted 124 gene mutation clinical laboratory tests and then lied about it to cover up his lack of following standard operating procedures. (Photo copyright: PennLive/Paul Chaplin.)
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.
—Jon Stone
Related Information:
Former Hershey Medical Center Research Technologist Charged with Healthcare Fraud
Former Hershey Medical Center Research Technologist Pleads Guilty to Making False Statements About Cancer Tests
Former Hershey Med Center Research Technologist Indicted for Fraud
Former Hershey Medical Center Worker Pleads Guilty to Lying About Cancer Testing Procedure
Hospital Staffer Admits to Lying About Genetic Cancer Tests
Former Hershey Med Tech Pleads Guilty to Lying About Fudging Cancer Testing
U.S. v. Benko No. 1:15-cr-00159
United States of America v. Floyd A. Benko, Defendant
Sep 23, 2015 | Instruments & Equipment, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations
Antibody validation standards would help ensure reproducibility of research studies and improve the consistency medical laboratory test results
As science and industry gets better at measuring things and assessing quality, the acceptable standard often comes into question. This seems to be happening with antibodies, the most common reagents used in diagnostics, clinical laboratory diagnostic tests, and medical research. In many cases, the end result is that companies and their suppliers must use new technologies and quality methods to revise the “old way” and create products that have measurable better quality.
The techniques currently used to validate antibodies is the topic of a recently-published scientific paper. The authors of a paper published in the March, 2010, issue of Biotechniques pointed out, antibody validation and standardization ensure study reproducibility, which is critical to accuracy. And yet, no standard guidelines define how these important biological tools should be validated prior to use.
Thus, researchers participating in a recent webinar, presented by The Scientist expressed concern that—without improved antibody validation and standardization—the accuracy of published research is in question and diagnostic test results, such as those produced by medical laboratories, will continue to be inconsistent. (more…)
