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Clinical Laboratories and Pathology Groups

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Clinical Laboratories and Pathology Groups

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Johns Hopkins’ Test Drone Travels 161 Miles to Set Record for Delivery Distance of Clinical Laboratory Specimens

Onboard cooling system ensures samples remain viable for medical laboratory analysis after three-hour flight across Arizona desert

Clinical laboratories and anatomic pathology groups could soon be receiving blood samples and tissue specimens through the air by medical drone. The technology has been tested successfully in Europe, which Dark Daily reported in July. Now, Johns Hopkins University Medicine (JHUM) has set a record in America for the longest distance drone delivery of viable medical specimens.

In a project to demonstrate the viability of using drones to transport medical laboratory specimens, the Johns Hopkins University team flew a drone with specimens more than 161 miles across the Arizona desert. The goal is to bring autonomous medical delivery drones a step closer to transforming how specimens get transported across long distances, according to a Johns Hopkins press release.

A previous Johns Hopkins study in 2015 proved common and routine blood tests were not affected when medical laboratory specimens were transported in up to 40-minute flights on hobby-sized drones. This latest research provides evidence that unmanned aircraft may be able to successfully and quickly shuttle medical specimens even longer distances between remote hospitals and medical laboratories.

Transporting Clinical Laboratory Samples by Air Can Save Lives

In conducting its most recent study, Johns Hopkins researchers obtained paired chemistry and hematology samples from 21 adults (84 samples in total). One sample from each pair was held at a drone test range in a car with active cooling. Remaining samples were flown for three hours in a drone with a Johns Hopkins-designed onboard payload-cooling system to maintain temperature control in the hot desert environment.

A temperature-controlled specimen transport container (above) designed by the Johns Hopkins University research team ensured the blood samples remained cooled and were viable for testing after the three-hour drone flight in the Arizona heat. The project demonstrated the viability of using drones to transport medical laboratory specimens. (Photo copyright: Johns Hopkins Medicine.)

After the 161-mile flight, all samples were transported 62 miles by car to the Mayo Clinic in Scottsdale, Ariz., for testing. Flown and not-flown paired samples showed similar results for red blood cell, white blood cell and platelet counts, and sodium levels, among other results. Only glucose and potassium levels revealed minor but statistically significant differences in results.

Pathologist Timothy Amukele, MD, PhD (above), led a team of researchers at Johns Hopkins University School of Medicine that set a new distance delivery record for medical drones after successfully transporting human blood samples 161 miles across the Arizona desert. The test flight adds to the growing evidence that unmanned aircraft may be the most effective way to quickly transport blood and other medical samples to clinical laboratories. (Photo copyright: Johns Hopkins Medicine.)

In a report of the findings published in the American Journal of Clinical Pathology (AJCP), the research team concludes that long drone flights at high temperature “do not appear to affect the accuracy of 17 of the 19 test types in this study.” However, they note, “Time- and temperature-sensitive analytes such as glucose and potassium will require good pre-planning and stringent environmental controls to ensure reliable results.”

The John Hopkins team believes their achievement adds to mounting evidence that drone transportation can transform the delivery of clinical laboratory specimens.

“We expect that in many cases, drone transport will be the quickest, safest, and most efficient option to deliver some biological samples to a laboratory from rural or urban settings,” stated Timothy Kien Amukele, MD, PhD, Assistant Professor of Pathology at Johns Hopkins University School of Medicine and the paper’s senior author, in a Johns Hopkins Magazine article.

“Getting diagnostic results far more quickly under difficult conditions will almost certainly improve care and save more lives,” Amukele added.

Full Drone Delivery Network Operating Over Switzerland

Medical drones are rapidly moving from demonstration projects to active use. As Dark Daily previously reported, Switzerland is establishing a delivery network of medical drones in the city of Lugano. In March 2017, drone logistics system developer Matternet, based in Menlo Park, Calif., received authorization from the Swiss Federal Office for Civil Aviation (FOCO) for full operation of drone logistics networks over densely populated areas in Switzerland. Working in partnership with Swiss Post (Switzerland’s postal service) and the Ticino EOC hospital group, Matternet successfully completed roughly 100 drone transport test flights between two of Ticino EOC’s hospitals in Lugano.

Another major player in medical drone delivery is Zipline, a Silicon Valley-based drone delivery company that since October 2016 has flown more than 14,000 flights in Rwanda, delivering 2,600 units of blood. The company’s foothold in Africa expanded in August when Tanzania announced it was partnering with Zipline to launch the “world’s largest drone delivery service to provide emergency on-demand access to critical and life-saving medicines.” Tanzania will establish four distribution centers that will use more than 100 drones to make up to 2,000 flights a day.

The emergence of medical drones not only could speed up diagnoses for patients in remote regions of the world and rural communities, but also could revolutionize anatomic pathology specimen deliveries to clinical laboratories in urban areas by providing a faster, more reliable and lower-cost delivery option than third-party couriers using ground transportation.

—Andrea Downing Peck

Related Information:

Study Sets New Distance Record for Medical Drone Transport

Drone Transport of Chemistry and Hematology Samples Over Long Distances

Using Drones to Transport Blood Samples Could Speed Diagnosis, Treatment

Drone Carrying Blood Samples Travels 160 Miles in Arizona Desert to Set New Record

Matternet Unveils the Matternet Station

Tanzania Announces World’s Largest National Drone Delivery Network Partnering with Zipline

Drones Used to Deliver Clinical Laboratory Specimens in Switzerland

Telemedicine Gaining Momentum in US as Large Employers Look for Ways to Decrease Costs; Trend Has Implications for Pathology Groups and Medical Laboratories

Increased use of telemedicine may create opportunities for clinical laboratories to deliver increased value to both physicians and nurses

Recent data shows widespread employer adoption of telehealth services may soon become a reality. However, studies also show virtual provider visits and other telemedicine technologies are unlikely to diminish the role of clinical laboratories in providing the data required for diagnosis and treatment decisions. Instead, laboratories and anatomic pathology groups will likely see changes in how samples are collected from patients using telemedicine and how medical laboratory test results are reported, as access to telemedicine grows.

A recent National Business Group on Health (NBGH) survey indicates that in 2018 “virtually all [large] employers (96%) will make telehealth services available in states where it is allowed.” The survey was conducted between May and June 2017, with 148 large employers participating.

Christine Smalley, Managing Director with consulting firm Claremont Hudson, divides telemedicine technology into three distinct segments:

1.     Provider-to-provider;

2.     Remote patient monitoring; and,

3.     Patient-to-provider.

In an article she penned for MedCityNews, Smalley calls provider-to-provider telemedicine the “most evolved to-date” segment of the telehealth trend. She highlights ICU stroke care with remote consults and monitoring as an example of its “success,” and notes a large potential for growth in remote patient monitoring (RPM). Smalley cites a Berg Insight report that estimates 50-million patients will use remote monitored devices by 2021. However, Smalley also notes consumer acceptance of patient-to-provider telemedicine has fallen short of industry expectations.

While virtual office visits—where patients have access to physicians via telephone or videoconferencing—grab headlines, Smalley argues that “several factors” are hindering adoption.

“Reimbursement is not yet universal,” she notes. “But consumers are growing used to paying more out-of-pocket with high-deductible plans. Physicians have long resisted change in how they practice, and many remain lukewarm at best about telemedicine. It’s no coincidence that many of the innovations and pioneering models have come from outside of healthcare delivery … The barriers that loom the largest may likely be consumer awareness and trial.”

The Center for Connected Health Policy (CCHP) reports that 35 states have laws governing private payer reimbursement of telehealth, a number that has not changed since 2016. According to a CCHP press release, some state laws require reimbursement be equal to in-person visits, though not all laws mandate reimbursement.

Adopting Existing Retail Models to Promote Telemedicine to Patients

Smalley contends “smart marketing” will be needed to get consumers to leverage the telemedicine options that are becoming available to them. She says simply offering video or telephone visits is not enough. She encourages integrated delivery systems to take a page out of retailers’ playbooks.

“Look at how retailers, like Walmart, integrate online shopping and the store experience by offering side-by-side options supporting product delivery and in-store pickup. Telemedicine options ultimately need to be offered in a way that feels integrated and seamless to the health consumer,” she suggested, in her MedCityNews article. One example, she notes, would be providing an easy-to-navigate link to a virtual visit on a healthcare network’s urgent care webpage.

Telemedicine isn’t just about the office visit. Pathologists such as J.B. Askew, MD, PA (above), have embraced telepathology technology to bring pathology interpretation services to remote and resource strapped areas worldwide. (Click on image above to watch a video of Askew demonstrating the use of a telepathology imaging system.) (Image/video copyright: J.B. Askew, MD, PA, North Houston Pathology Associates/Meyer Instruments.)

Click image above to see YouTube video

Healthcare Spending Could Increase Due to Telehealth

While health plans have zeroed in on telehealth as a way to drive down healthcare costs, a 2017 RAND Corp. study published in Health Affairs found virtual visits to physicians might not decrease spending, though access to care is improved.

“Instead of saving money by substitution [replacing more expensive visits to physician offices or EDs], direct-to-consumer telehealth may increase spending by new utilization [increasing the total number of patient visits],” a MedCityNews article suggests.

The RAND study examined commercial claims data of workers enrolled in the California Public Employees’ Retirement System (CalPERS) Blue Shield of California HMO (Health Maintenance Organization) from 2011-2013. Researchers focused on care received for acute respiratory infections. According to a RAND press release, net annual spending for acute respiratory infections increased by $45 per telehealth user.

“Given that direct-to-consumer telehealth is even more convenient than traveling to retail clinics, it may not be surprising that an even greater share of telehealth services represents new medical use,” noted Lori Uscher-Pines, PhD, a RAND Policy Researcher. “There may be a dose response with respect to convenience and use: the more convenient the location, the lower the threshold for seeking care and the greater the use of medical services.”

Telehealth in Clinical Laboratories

Will telehealth services offered by hospital networks and healthcare providers impact clinical laboratories? While a physical visit is still required for drawing blood, collecting urine, or performing pathology testing, interpretive digital pathology, such as Whole Slide Imaging (AKA, Virtual Slide), does enable pathologists to provided distance interpretation services of blood tests to remote and/or resource deficient areas of the world, as Dark Daily reported in past e-briefings. This could become a substantial revenue stream in the future if telepathology’s global popularity continues to rise.

—Andrea Downing Peck

Related Information:

Telemedicine Is on the Rise, Including for Labs

Large U.S. Employers Project Health Care Benefit Costs to Surpass $14,000 per Employee in 2018, National Business Group on Health Survey Finds

Large Employers’ 2018 Health Care Strategy and Plan Design Survey

Take a Lesson from Retail to Improve Patient Adoption

mHealth and Home Monitoring

Direct-to-Consumer Telehealth Prompts New Use of Medical Services; Not Likely to Decrease Health Spending

State Telehealth Laws and Reimbursement Policies, April 2017

CCHP Releases Fifth Edition of 50 State Telehealth Lawns and Reimbursement Policies Report

Almost All Large Employers Plan to Offer Telehealth in 2018, but Will Employees Use It?

Direct-to-Consumer Telehealth May Increase Access to Care but Does Not Decrease Spending

International Telemedicine Gains Momentum, Opening New Markets for Pathologists and Other Specialists

‘Nighthawk’ Radiology Services Expand to Hospital Pharmacies: Could Pathology Laboratories Be Next?

From Micro-hospitals to Mobile ERs: New Models of Healthcare Create Challenges and Opportunities for Pathologists and Medical Laboratories

Threats to Profitability Causing Clinical Laboratories, Pathology Groups to Take on Added Risk by Entering into ‘Problematic’ Business Relationships and Risky Pricing Plans

Medical laboratory leaders urged to scrutinize pricing policies, billing decisions, and structural relationships that could trigger commercial payer and regulatory action

Clinical laboratories and pathology groups face another blow to their financial health on January 1, 2018, when new Medicare Part B price cuts take effect. Faced with increasing competition and declining reimbursement rates for anatomic pathology testing, medical laboratories will begin 2018 with their profitability under threat. In addition, healthcare legal experts warn many medical laboratory leaders risk further financial hardships by establishing “problematic” business relationships or developing pricing plans that put their labs at “unreasonable risk” with commercial payers and government regulators.

Financial Pressures Lead Clinical Laboratories to Risky Deals and Policies

One such expert is, attorney Jeffrey J. Sherrin, President and Partner at O’Connell and Aronowitz in Albany, New York. He contends that financial pressures are the impetus for many laboratories’ questionable deal-making and pricing policies.

“We’re increasingly dealing with proposed structures that clinical labs are entering into or considering entering into to remain viable, but without properly assessing how those relationships may run afoul of federal or state law or provider agreements,” Sherrin noted in an interview with Dark Daily. “If that doesn’t keep the labs up at night, it keeps us up at night!”

Tougher Auditing and Billing Scrutiny

While the “overwhelming majority of lab directors, owners, and managers are honest and law abiding,” Sherrin maintains they are “stepping into a minefield” by failing to properly vet decisions regarding:

1.     Lab billing and referral arrangements that could violate federal and state anti-kickback or fee-splitting laws, or trigger violations of provider agreements with health insurers.

2.     Participation in healthcare Management Service Organizations (MSOs) that involve “billing schemes” rather than legitimate administrative services, marketing, or data-collection activities.

3.     Pricing plans and billing policies that could trigger increased scrutiny by government and commercial payers over balance-billing of patients, and waiver or partial waiver of co-pays and deductibles.

In an era of shrinking reimbursements and limited access to healthcare networks, Sherrin urges medical laboratory leaders to be aware of another new reality: tougher audits from commercial payers whose investigators “perceive that there is rampant fraud in the industry” that extends beyond toxicology/pharmacogenomics or molecular/genetic testing laboratories.

“In payers’ minds, it’s across the board,” Sherrin says. “When they see patterns of limiting or capping or waiving of patient responsibility, their normal inclination is to assume this is part and parcel of some fraudulent scheme or practice, as opposed to a proper business decision.”

Proactive Steps to Improve Medical Lab Leader Decision-Making

Seeking guidance from a healthcare attorney before establishing new business relationships, and pricing or billing policies, is one way to increase your laboratory’s odds of surviving payer action.

“Most labs adopt a pricing policy without fully vetting whether they are doing it the right way, the best way, or the way that creates as little risk as possible,” Sherrin notes. “A high percentage of labs have not approached this issue with a degree of scrutiny as to whether the marketing of their test menu, their prices, and how they bill puts them in a better or worse position. Most are making business decisions based on what they need to do competitively without having the ramifications and implications analyzed.”

To help medical laboratory and pathology group leaders prepare for the perils they face, Dark Daily’s upcoming webinar, “Tougher Lab Regulations and New Legal Issues in 2018: More Frequent Payer Audits, Problems with Contract Sales Reps, Increased Liability for CLIA Lab Directors, Proficiency Testing Violations, and More,” will reveal how lab leaders can take proactive steps to navigate the tough lab regulations and legal issues that lay ahead.

To attend this critical educational opportunity, click here to register (or place this link into your browser: https://ddaily.wpengine.com/product/tougher-lab-regulations-and-new-legal-issues-in-2018-more-frequent-payer-audits-problems-with-contract-sales-reps-increased-liability-for-clia-lab-directors-proficiency-testing-violations-and).

Healthcare attorney Jeffrey W. Sherrin, President and Partner, O’Connell and Aronowitz, will be one of three featured speakers during a new Dark Daily webinar on the upcoming Medicare Part B price cuts, and the critical legal and compliance issues facing clinical laboratories and pathology groups in 2018. (Photo copyright: O’Connell and Aronowitz.)

This crucial learning event takes place on Wednesday, November 8, 2017, at 1 p.m. EST.  Sherrin will be joined by David W. Gee, JD, Partner at Davis Wright Tremaine LLP in Seattle, Wash., and Richard Cooper, JD, Chair of the National Healthcare Practice Group, McDonald Hopkins LLC, in Cleveland.

These three attorneys are among the nation’s foremost experts in issues unique to clinical laboratories, pathology groups, hospital labs, toxicology/pharmacogenomics labs, and molecular/genetic testing labs. Following our speakers’ presentations, there will be a question and answer period, during which you can submit your own specific questions to our experts.

You can’t afford to miss this opportunity. Click here to get up to speed on the most serious regulatory, compliance, and managed care contracting issues confronting all clinical laboratories today. This webinar will provide solutions to the perils facing labs now and in 2018 by helping you map a proactive and effective course of action for your clinical lab or pathology group.

—Andrea Downing Peck

Related Information:

Tougher Lab Regulations and New Legal Issues in 2018: More Frequent Payer Audits, Problems with Contract Sales Reps, Increased Liability for CLIA Lab Directors, Proficiency Testing Violations, and More

What Every Lab Needs to Know about the Medicare Part B Clinical Laboratory Price Cuts That Take Effect in Just 157 Days, on Jan. 1, 2018

Nation’s Most Vulnerable Clinical Laboratories Fear Financial Failure If Medicare Officials Cut Part B Lab Fees Using PAMA Market Price Data Final Rule

‘Death by 1,000 Knives’ Could Be in Store for Clinical Laboratories, Pathology Groups Not Prepared to Comply with New Medicare Part B Regulations

Medical laboratory leaders and pathologists must be fully aware of the coming legal and regulatory changes taking place starting January 1, 2018, or risk fines and decreased reimbursements

January 1, 2018, marks the start of new Medicare Part B price cuts for clinical laboratory  and anatomic pathology testing. But decreasing reimbursement rates is just one issue facing medical laboratory leaders. The other is the increasingly rigorous regulatory environment poised to ensnare labs and pathology groups unprepared to navigate the dark waters of government compliance.

Tougher payer audits, higher recovery demands, and enforcement policies that increase the personal liability of CLIA lab directors and lab executives, are reasons why attorney David W. Gee, JD, a Partner at Davis Wright Tremaine LLP in Seattle, argues that laboratories need to step up their focus on compliance and due diligence. He notes laboratories must guard against “death by 1,000 knives” in this new landscape.

Insufficient Focus on Compliance Brings Consequences to Clinical Laboratories and Their Management

“There are more and more people and agencies whose focus it is to regulate and watch the dollars and make sure there is integrity in the system,” noted Gee in an interview with Dark Daily. “That includes not only the formerly regular players—the OIG [Office of Inspector General, US Department of Health and Human Services] and DOJ [Department of Justice]—but you’ve got an increasing number of states with their own False Claims Acts. You’ve got state agencies looking at opportunities to clean up the system and to tag along with other investigations going on, as well as commercial payers who have become more active in pursuing litigation and other measures against practices they allege to be fraudulent.”

Faced with these emerging trends, Gee stresses that labs must:

1.     Recognize the increased personal liability facing lab directors, owners, and management, and take steps to mitigate risk of enforcement actions that not only expose executives to potential penalties but also jeopardize the financial health of lab organizations.

2.     Understand the importance of meaningful and sustained investment in compliance (including providing compliance officers with the resources to manage an increasingly complex job) and leverage OIG guidance to assess gaps and risks in compliance programs.

3.     Be aware of risks inherent in third-party marketing agreements, which can result in short-term spikes in order volume, but which also could reduce “lines of sight” to clients, making it even more difficult to adhere to compliance standards.

Gee believes the emphasis labs place on cost control and “running lean” often results in a lack of attention being paid to compliance. He argues today’s competitive environment increases the need for laboratory directors to ensure proper business practices are followed and “compliance fundamentals are not overlooked in the haste to compete for the business of referral sources.”

Healthcare attorney and Partner, David W. Gee, JD, of Davis Wright Tremaine, LLP, in Seattle will be one of three featured speakers during a new Dark Daily webinar on the Medicare Part B price cuts, and the critical legal and compliance issues clinical laboratories and pathology groups face starting in 2018. (Photo copyright: Davis Wright Tremaine, LLP.)

CLIA-Lab Directors to Be Held Personally Liable for Compliance Failures

Because federal regulators are considering holding CLIA-lab directors personally liable for compliance failures, Gee suggests laboratory executives should be motivated to put effective compliance programs in place.

“The best reason I can give for insisting as a lab director that the company actually has a successful and effective compliance program is that these days they stand to lose,” he argues. “The ability to prove you are not complicit—and that you are not the driver of things that have gone wrong—comes down to having an effective and well-documented compliance program so you are on record. And so there’s evidence that, as an engaged lab leader, you tried to do the right thing.”

Educational Opportunities for Lab Leaders

To help medical laboratory and pathology group leaders prepare for the perils they face, and take proactive steps to navigate the tough lab regulations and legal issues that lay ahead, click here to register for Dark Daily’s upcoming webinar “Tougher Lab Regulations and New Legal Issues in 2018: More Frequent Payer Audits, Problems with Contract Sales Reps, Increased Liability for CLIA Lab Directors, Proficiency Testing Violations, and More,” (or place this link into your browser: https://ddaily.wpengine.com/product/tougher-lab-regulations-and-new-legal-issues-in-2018-more-frequent-payer-audits-problems-with-contract-sales-reps-increased-liability-for-clia-lab-directors-proficiency-testing-violations-and).

This crucial learning event takes place on Wednesday, November 8, 2017, at 1 p.m. EST. Gee will be joined by Jeffrey J. Sherrin, President and Partner, O’Connell and Aronowitz in Albany, New York, and Richard Cooper, Chair, National Healthcare Practice Group, McDonald Hopkins, LLC, in Cleveland.

These three attorneys are among the nation’s foremost experts in issues unique to clinical laboratories, pathology groups, hospital labs, toxicology/pharmacogenomics labs, and molecular/genetic testing labs. Following our speakers’ presentations, there will be a question and answer period, during which you can submit your own specific questions to our experts.

You can’t afford to miss this opportunity. Click here to get up to speed on the most serious regulatory, compliance, and managed care contracting issues confronting all labs today. This webinar will provide solutions to the perils facing labs now and in 2018 by helping you map a proactive and effective course of action for your clinical lab or pathology group.

—Andrea Downing Peck

Related Information:

Tougher Lab Regulations and New Legal Issues in 2018: More Frequent Payer Audits, Problems with Contract Sales Reps, Increased Liability for CLIA Lab Directors, Proficiency Testing Violations, and More

What Every Lab Needs to Know about the Medicare Part B Clinical Laboratory Price Cuts That Take Effect in Just 157 Days, on Jan. 1, 2018

Nation’s Most Vulnerable Clinical Laboratories Fear Financial Failure If Medicare Officials Cut Part B Lab Fees Using PAMA Market Price Data Final Rule

Hershey, Pennsylvania, Clinical Laboratory Technician Indicted in 2015 for Fraudulent Cancer Test Results Pleads Guilty to False Statement Charges

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

Scientists Encode Malware with Synthesized DNA That Targets DNA Analysis Software Commonly Found in Gene Sequencers Used by Clinical Laboratories

Researchers demonstrated it was feasible to encode digital malware onto a strand of synthesized DNA and infect the gene sequencers and computer networks used by medical laboratories

As if anatomic pathology groups and clinical laboratory leaders don’t already have enough to think about, here comes a security vulnerability right out of a sci-fi thriller. Researchers at the University of Washington (UW) have used synthesized DNA to encode digital malware into a physical strand of DNA capable of establishing a remote connection to the computer network on which the sequenced DNA is read!

Stated differently, researchers have now demonstrated that is possible for bad guys to hack into a medical laboratory’s instrument systems and computer network using a physical strand of synthesized DNA that is encoded with digital malware.

Another Threat to Clinical Laboratories, Pathology Groups?

Does this translate into an immediate security issue for medical laboratories? For now, the threat is only theoretical. While researchers did succeed, their study findings should provide some comfort to pathology groups or medical laboratories worried about the implications of DNA-based malware. The UW researchers published their findings at the 2017 USENIX Security Symposium.

Synthetic DNA Malware Exploit is More Proof-of-Concept than Immediate Threat

At its core, computer code (AKA source code) is similar to DNA in that it is composed of a set number of states—with binary, zeroes, and ones. This led UW researchers to question whether they could translate the AGCT elements (adenine, guanine, cytosine, and thymine) of DNA into binary code capable of hacking DNA sequencers and accessing the information they contain.

In an article in The Atlantic, Tadayoshi Kohno, PhD, Short-Dooley Professor in the Department of Computer Science and Engineering at UW, who led the research team, noted that, “The present-day threat is very small, and people don’t need to lose sleep immediately. But we wanted to know what was possible and what the issues are down the line.”

Complexity of Engineering a DNA-Powered Computer Virus

To begin the process, researchers needed to create a specific DNA strand encoded with the exact proteins that would later convert into their exploit. An article in ArsTechnica suggests this would be a challenge due to the physical properties of DNA’s double-helix design.

In the article, John Timmer, PhD, wrote, “DNA with Gs and Cs forms a stronger double-helix. Too many of them, and the strand won’t open up easily for sequencing. Too few, and it’ll pop open when you don’t want it to.”

The study shows it took multiple attempts to find a DNA sequence that would both carry the malware code and withstand the synthesizing and sequencing processes. Even then, researchers needed an exploit for the software used on sequencers in clinical laboratories and other diagnostics providers to prove their theory. Study authors used their own modified version of an open-source sequencing software, adding an exploit they could target, instead of a version of the software already publicly in use.

Lee Organick (above left), Karl Koscher (center), and Peter Ney (right) worked with Luis Ceze and Tadayoshi Kohno, PhD, at the University of Washington to develop the DNA sequence containing the malware code. The researchers determined that it was feasible for the gene instruments used by clinical laboratories to be infected with the malware, which could then move to infect a clinical lab’s computer network. (Photo copyright: University of Washington.)

With their proteins synthesized and customized software in place, researchers still faced challenges getting the code to trigger. “With reads randomly appearing in an FASTQ file,” the researchers noted, “we would expect the modified program to be exploited 37.4% of the time.”

As with genetic code, the binary code of a program is highly sensitive to errors. Any misread bases or splitting of the code resulted in failure. When sequencers only read a few hundred bases at a time, ensuring the code doesn’t hit one of these splits is a challenge.

One unique difference between binary and genetic code also caused trouble—genetic sequences aren’t direction dependent, while binary sequences are. If the code is read in reverse, it won’t execute properly.

Future Concerns for Clinical Laboratories and Genetic Researchers

Today, the threat to medical laboratories and the sensitive data generated by sequencing is minor. However, tomorrow that threat could be more common.

In a WIRED article on the subject, Jason Callahan, Chief Information Security Officer for Illumina stated, “This is interesting research about potential long-term risks. We agree with the premise of the study—that this does not pose an imminent threat and is not a typical cyber security capability.”

Don Rule, founder of Translational Software, agrees. When asked about the threat posed to clinical laboratories, he said, “… if you have to pre-introduce the hack in the analytics program, this is a pretty circuitous way to take over a computer. I can see how it is feasible and right now Norton Antivirus is not looking for viruses encoded in the AGCT code set, but we are right not to lose a lot of sleep over it.”

However, as genetic sequencing becomes a common part of medicine, attackers might have increased reason to disrupt services or intercept data. The UW researchers cite “important domains like forensics, medicine, and agriculture” as potential targets.

While their successful attack was highly engineered, their research into open-source sequencing software revealed a range of common security weaknesses. Many clinical laboratories and anatomic pathology groups also run proprietary analysis software or use hardware with embedded software.

They recommend that medical laboratories work to centralize software updates and create ways to verify data and patches through digital signatures or other secure measures.

Already, genetic researchers take care to avoid synthesizing potentially dangerous sequences, and to contain tests and data. But this study shows that not all threats come from within the research or clinical laboratory environment. Both engineers of sequencing technology and hardware—and the medical laboratories using them—will need to optimize operations and monitor trends closely to see how security issues evolve alongside sequencing capabilities.

—Jon Stone

 

Related Information:

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Computer Security and Privacy in DNA Sequencing

Computer Security, Privacy, and DNA Sequencing: Compromising Computers with Synthesized DNA, Privacy Leaks, and More

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Researchers Encode Malware in DNA, Compromise DNA Sequencing Software

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The Ultimate Virus: How Malware Encoded in Synthesized DNA Can Compromise a Computer System

Researchers Hacked into DNA and Encoded It with Malware

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