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Clinical Laboratories and Pathology Groups

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17 Former Employees Accuse Orig3n of Clinical Laboratory Test Inaccuracies, Contamination, and Fabricated Test Results

This is not the first time genetic-testing company Orig3n has been scrutinized by state and federal investigators over its business practices

It’s not often that multiple employees of a clinical laboratory company go public with criticism about the quality of their lab company’s tests. But that is what is happening at Orig3n. Problems at the Boston-based genetic testing company were the subject of an investigative report published by Bloomberg Businessweek (Bloomberg).

In September, Bloomberg reported that 17 former Orig3n employees said the company’s Deoxyribonucleic acid (DNA) tests sometimes failed to deliver the intended results or were often contaminated or inaccurate. The individuals had been employed by the company as managers, lab technicians, software engineers, marketers, and salespeople between 2015 and 2018.

The former employees claimed that Orig3n “habitually cut corners, tampered with or fabricated results, and failed to meet basic scientific standards,” Bloomberg reported. The individuals also stated that advice intended to be personalized to individual consumers’ genetic profiles was often just generic information or advice that had no scientific basis.

According to Bloomberg, the individuals also alleged that Orig3n’s lab was careless in its handling of genetic samples in several ways, including:

  • Multiple samples being labeled with the same barcode;
  • DNA and blood samples for stem cell bank misplaced or mixed up;
  • No controls to ensure accuracy;
  • Handling methods that could lead to contamination; and
  • Fabricating results when a test outcome was unclear.

The former employees also stated that “Orig3n ran tests without proper authorization in its lab at the 49ers’ stadium, and that managers regularly compelled them to write positive reviews of Orig3n’s tests on Amazon.com and Google to offset waves of negative feedback,” Bloomberg reported.

“Accurate science didn’t seem to be a priority. Marketing was the priority,” said a former lab technician who spoke with Bloomberg on the condition of anonymity. Orig3n denied the accusations in a statement, describing them as “grossly inaccurate,” and claimed the former employees were simply disgruntled.

“In some cases, former employees are former employees for a reason,” Orig3n Chief Executive Officer Robin Smith told Bloomberg. “We’ve found after employees are gone that they have not done things appropriately.”

Jessica Stoll, MS, CGC (above), a certified genetic counselor and Associate Director of the Gastrointestinal Cancer Risk and Prevention Clinic at the University of Chicago Medicine, told NBC, “The majority of genetic testing is still a gray area and there’s always the possibility of uncertain results. I don’t find them particularly useful, and in some cases I can actually find them harmful.” (Photo copyright: Cancer Wellness Center.)

Is it Dog or Human DNA?

In 2018, NBC Chicago (NBC) conducted an investigation into various consumer DNA testing kits. NBC sent DNA samples to several different testing companies. This included non-human samples, which NBC’s investigators had obtained from a female Labrador Retriever.

With the exception of Orig3n, all of companies identified the DNA as non-human and did not process the kits. Orig3n did, however, process the canine DNA. It then returned a seven-page analysis that suggested the subject of the sample “would probably be great for quick movements like boxing and basketball, and that she has the cardiac output for long endurance bike rides or runs,” NBC reported.

This would be funny if it weren’t so concerning.

Following reports that it had processed dog DNA, Orig3n stated it had made changes and improvements to the company’s testing methodologies. Smith also stated Orig3n’s lab protocols had been improved as well.

“Sometimes we look at the accuracy of things and go, ‘Man, that’s not working,’” Smith told Bloomberg. “Our approach and our philosophy is [sic] to constantly improve the products.” 

Serious Accusations of Clinical Laboratory Malfeasance

Founded in 2014 with the intent of creating the world’s largest stem cell bank, by 2016, Boston-based Orig3n had refocused its attention on the burgeoning field of direct-to-consumer DNA testing. On its website, Orig3n sells several DNA-testing kits with varying costs.

Orig3n’s attempt to offer free genetic tests to large numbers of people at a professional sporting event in the fall of 2017 may be what caught the attention of federal investigators and led to a deeper investigation. Dark Daily previously covered this controversy, which centered around Orig3n’s plan to distribute free genetic testing kits to fans at a Baltimore Ravens football game.

In that situation, state and federal healthcare regulators blocked the giveaway over concerns about protected health information (PHI). Now, Orig3n is being accused of questionable business practices by 17 of its former employees. 

The former employees’ statements that the company’s genetic testing lab did not follow appropriate test protocols—and that it allegedly mishandled specimens and even reported false test results—are serious allegation of malfeasance and warrants an investigation.

Pathologists and clinical laboratory managers know that patient harm can potentially result from inaccurate genetic test results if used for clinical purposes. Dark Daily will continue to follow the investigation into Orig3n.

—JP Schlingman

Related Information:

DNA Company Tampered with Results, Former Employees Say

Home DNA Kits: What Do They Tell You?

Orig3n Holds Inaugural Ravens DNA Day on September 17 at M and T Bank Stadium to Kick Off the Season

Orig3n Partners with San Francisco 49ers to Reward Fans for Contributions to Advancing the Future of Medicine through Genetics and Regenerative Medicine Research

State and Federal Agencies Throw Yellow Flag Delaying Free Genetic Tests at NFL Games in Baltimore—Are Clinical Laboratories on Notice about Free Testing?

Medical Tourism Lowers Healthcare Costs for Companies and Their Employees, But Is It Good Medicine for Patients and Can Clinical Laboratories Participate?

Some companies save so much in healthcare cost they pay their employees to participate in medical tourism programs

Medical tourism is not new, but it’s changing, and clinical laboratories have a role to play in the models employers use to save money on their employees’ health coverage costs.

Employers that manage the entire process—from securing passports for their employees, to ensuring they have access to high-quality care outside the country’s borders—report saving money as well as simplifying the process for their employees. An apparent win-win.

However, questions linger about:

  • Availability of diagnostic testing and clinical laboratories;
  • If patients treated outside the US receive adequate protections; and
  • Whether the quality of care is equal to that in the US.

One recent example of a company helping employers and employees receive high quality care outside of the US is NASH—the North American Specialty Hospital. NASH was featured in a Kaiser Health News (KHN) article that described one patient’s experience traveling to Cancún for a surgical procedure.

Location, Pre-Existing Conditions, Length of Stay, Etc., Affect Final Bill in US

One of NASH’s corporate clients is Ashley Furniture Industries. Headquartered in Arcadia, Wis., the American home furnishings manufacturer and retailer employs approximately 17,000 people, including Terry Ferguson. Terry’s wife, Donna, is the patient highlighted in the KHN story.

One of the healthcare providers NASH partners with is Galenia Hospital, a 55-bed general services hospital in Cancún, Mexico. NASH leases the entire third floor of the hospital. Galenia is next door to a Four Points Sheraton Hotel, making lodging a simple matter for medical tourists.

Currently, NASH focuses on orthopedic surgeries such as total knee replacements, the medical procedure Donna Ferguson underwent.

A 2015 BlueCross BlueShield study showed that costs for total-knee-replacement surgery in the US averaged about $31,000. However, depending on where the surgery takes place, it can cost as low as $11,317 (Alabama) and as high as $69,654 (New York City). Pre-existing conditions, length of time in the operating room, number of days in the hospital, and numerous other factors contribute to the final bill.

NASH, however, sets the final price is up front.

Some Companies Pay Their Employees to Use Medical Tourism

With the average cost for the surgery coming in at around $12,000, the cost savings to employers is so great some companies actually pay employees who are willing to travel for procedures, KHN reported. Donna Ferguson paid no co-pays for her surgery, paid nothing out of pocket for travel or lodging while in Cancún, and the Ferguson’s received a $5,000 check from Ashley Furniture.

Ferguson told KHN, “It’s been a great experience. Even if I had to pay, I would come back here because it’s just a different level of care—they treat you like family.”

That’s important for hospitals, clinical laboratories, and all healthcare providers in America to consider. In the minds of patients, quality of care starts with their experience at the hands of the provider.

Donna Ferguson (center) is shown above meeting Thomas Parisi, MD, JD (left), a surgeon with the Orthopedic Institute of Wisconsin, for the first time in Cancún the day before he performed her knee replacement surgery. Clinical laboratory tests, X-rays, and other diagnostics took place in the US prior to Ferguson’s authorization to undergo surgery in Mexico. (Photo copyright: Rocco Saint-Mleux/KHN.)

Clinical Laboratory Tests in US, Surgery in Mexico

Prior to traveling outside the US for surgery, Ferguson underwent a physical exam, X-rays, and other diagnostic testing to ensure the treatment approach was the best for her. Once that was confirmed, IndusHealth, Ashely’s medical travel plan administrator, “coordinated [Donna’s] medical care and made travel arrangements, including obtaining passports, airline tickets, hotel and meals,” for both Donna and Terry Ferguson, KHN reported.

It seems reasonable to assume that NASH has agreements with multiple clinical pathology laboratories and healthcare facilities throughout the US for patients to get the tests they need prior to surgery. Partnerships with medical tourism companies may well represent an avenue for pathology laboratories to pursue.

Protections for Patients

So, why hasn’t medical tourism become the healthcare juggernaut some experts predicted? Managed Care suggests one reason is that Americans tend to be skeptical of the quality of care they will receive in a foreign facility.

“Building a familiar culture in a foreign destination may be appealing to some American consumers, but I do not see it as a sustainable business,” Health consultant Irving Stackpole, PhD, MEd, Psychology, told KHN. “It’s not unusual for people thinking about this to have doctors, family, and friends who will see this as a high-risk undertaking.”

Several factors helped Ferguson feel better about her decision to travel to Mexico for surgery. One is that Galenia is credentialed.

Managed Care notes, “A number of organizations credential international facilities. The American Medical Association guidelines for medical tourism recommend that foreign medical providers have accreditation from the Joint Commission International or a similar organization.”

Galenia Hospital has accreditation from the Joint Commission International, the General Health Council of Mexico, as well as diamond-level accreditation from Canada’s Qmentum International Accreditation Program.

In addition to a credentialed facility and a highly trained surgeon, NASH also provides US malpractice insurance coverage, giving patients recourse in the event something goes wrong. Ferguson and American patients like her would be able to sue in the US if care under this arrangement was not successful.

Medical Tourism Pays Surgeon’s Full Fee

One fascinating twist in this story is that an American physician was flown to Cancun to perform this operation and was paid his full fee. The surgeon scheduled to perform Ferguson’s operation, Thomas Parisi, MD, JD, trained at the Mayo Clinic. He traveled from Wisconsin to Cancún to perform the procedure. “Dr. Parisi trained at Mayo, and you can’t do any better than that,” Ferguson told KHN.

KHN reported that Parisi spent less than 24 hours in Cancun and was paid $2,700 for this surgery. That fee is three times of the amount Medicare pays for this procedure. Further, Parisi’s fee was significantly above what many managed care plans would negotiate for this type of surgery.

American-trained physicians are common at many of the facilities credentialed by the Joint Commission International. “Many overseas hospitals are staffed in part by physicians and other health professionals who were trained in US hospitals. One hospital in India has 200 US-trained board-certified surgeons,” wrote James E. Dalen, MD, MPH, ScD, and Joseph S. Alpert, MD, in “Medical Tourists: Incoming and Outgoing,” published in The American Journal of Medicine (AMJMED).

“In the past, medical tourism has been mostly a blind leap to a country far away, to unknown hospitals and unknown doctors with unknown supplies, to a place without US medical malpractice insurance. We are making the experience completely different and removing as much uncertainty as we can,” James Polsfut, CEO and Chairman, North American Specialty Hospital (NASH), told KHN.

Clinical laboratories in America may find opportunities providing testing services to medical tourism organizations like NASH. It’s worth investigating.

 —Dava Stewart

Related Information:

To Save Money, American Patients and Surgeons Meet in Cancun

Blue Cross Blue Shield Association Study Reveals Extreme Cost Variations for Knee and Hip Replacement Surgeries

Understanding Knee Replacement Costs: What’s on the Bill?  

NASH Self-Pay Medical Tourism

Medical Tourism: Once Ready for Takeoff, Now Stuck at the Gate

Medical Tourists: Incoming and Outgoing

Medical Tourism Continues to Flourish as U.S. Patients Seek Lower Cost Healthcare in Overseas Countries

Healthcare Reform in the United States May Actually Increase Medical Tourism

Utah Public Employees Receive Transportation and a $500 Cash Bonus to Purchase Prescriptions in Mexico

Walmart Flies Employees to Top Hospitals for Surgeries in a Bid to Cut Healthcare Costs

Two New Definitive Healthcare Surveys Show Use of Inpatient Telehealth is Outpacing Outpatient Telehealth Services

Medical laboratories may find opportunities guiding hospital telehealth service physicians in how clinical lab tests are ordered and how the test results are used to select the best therapies

Telehealth is usually thought of as a way for patients in remote settings to access physicians and other caregivers. But now comes a pair of studies that indicate use of telehealth in inpatient settings is outpacing the growth of telehealth for outpatient services.

This is an unexpected development that could give clinical laboratories new opportunities to help improve how physicians in telehealth services use medical laboratory tests to diagnose their patients and select appropriate therapies.

Dual Surveys Compare Inpatient and Outpatient Telehealth Service Use

Definitive Healthcare (DH) of Framingham, Mass., is an analytics company that provides data on hospitals, physicians, and other healthcare providers, according to the company’s website. A survey conducted by DH found that use of telehealth solutions—such as two-way video webcams and SMS (short message service) text—has increased by inpatient providers from 54% in 2014 to 85% in 2019, a news release stated.

Meanwhile, a second Definitive Healthcare survey suggests use of telehealth in outpatient physician office settings remained essentially flat at 44% from 2018 to 2019, according to another news release.

For the inpatient report, Definitive Healthcare polled 175 c-suite providers and health information technology (HIT) directors in hospitals and healthcare systems. For the outpatient survey, the firm surveyed 270 physicians and outpatient facilities administrators.

DH’s research was aimed at learning the status of telehealth adoption, identifying the type of telehealth technology used, and predicting possible further investments in telehealth technologies.  

Most Popular Inpatient Telehealth Technologies

On the inpatient side, 65% of survey respondents said the most used telehealth mode is hub-and-spoke teleconferencing (audio/video communication between sites), Healthcare Dive reported. Also popular:

Fierce Healthcarereports that the telehealth technologies showing the largest increase by hospitals and health networks since 2016 are:

  • Two-way video/webcam between physician and patient (70%, up from 47%);
  • Population health management tools, such as SMS text (19%, up from 12%);
  • Remote patient monitoring using clinical-grade devices (14%, up from 8%);
  • Mobile apps for concierge services (23%, up from 17%).

“Organizations are finding new and creative ways through telehealth to fill gaps in patient care, increase care access, and provide additional services to patient populations outside the walls of their hospital,” Kate Shamsuddin, Definitive Healthcare’s Senior Vice President of Strategy, told Managed Healthcare Executive.

DH believes investments in telehealth will increase at hospitals as well as physician practices. In fact, 90% of respondents planning to adopt more telehealth technology indicated they would likely start in the next 18 months, the news releases state.

Most Popular Outpatient Telehealth Technologies

In the outpatient telehealth survey, 56% of physician practice respondents indicated patient portals as the leading telehealth technology, MedCity News reported. That was followed by:

  • Hub-and-spoke teleconferencing (42%);
  • Concierge services (42%);
  • Clinical- and consumer-grade remote patient monitoring products (21% and 12%).

While adoption of telehealth technology was flat over the past year, 68% of physician practices did use two-way video/webcam technology between physician and patient, which is up from 45% in 2018, Fierce Healthcare reported.

The graph above, taken from the Definitive Healthcare 2019 survey, shows the percentage of telehealth use among surveyed outpatient settings. “The results show how telehealth continues to be one of the core linchpins for providers,” Kate Shamsuddin, Definitive Healthcare’s Senior Vice President of Strategy, told Healthcare Dive. (Graphic copyright: Definitive Healthcare.)

MedCity News reports that other telehealth technologies in use at physician practices include:

  • Mobile apps for concierge service (33%);
  • Two-way video between physicians (25%);
  • SMS population management tools (20%).

Telehealth Reimbursement and Interoperability Uncertain

Why do outpatient providers appear slower to adopt telehealth, even though they generally have more patient encounters than inpatient facilities and need to reach out further and more often?

Definitive Healthcare reports that 20% of physician practice respondents are “satisfied with the practice’s current solutions and services,” and though telehealth reimbursement is improving, 13% are unsure they will be reimbursed for telehealth services.

The Centers for Medicare and Medicaid Services (CMS) states that Medicare Part B covers “certain telehealth services,” and that patients may be responsible for paying 20% of the Medicare approved amount. CMS also states that, effective in 2020, Medicare Advantage plans may “offer more telehealth benefits,” as compared to traditional Medicare.

“There is not only a need for more clarity around reimbursement policies, but also a need for more interoperable telehealth solutions that can be accessed through electronic health record or electronic medical record systems, as well as a better understanding about what types of telehealth options are available,” said Jason Krantz (above), CEO, Definitive Healthcare, in the outpatient telehealth survey news release. (Photo copyright: Definitive Healthcare.)

The increase in telehealth use at hospitals—as well as its increased adoption by physician offices—may provide clinical laboratories with opportunities to assist telehealth doctors with lab test use and ordering. By engaging in telehealth technology, such as two-way video between physicians, pathologists also may be able to help with the accuracy of diagnoses and timely and effective patient care.

—Donna Marie Pocius

Related Information:

Definitive Healthcare Survey: Inpatient Telehealth Adoption on the Rise

Definitive Healthcare Survey: 2019 Outpatient Telehealth Adoption Remains Flat

Telehealth Use Jumps at Inpatient Settings

Telehealth Use Jumps at Inpatient Facilities While Outpatient Adoption Remains Flat: Survey

Inpatient Telehealth Adoption Surges

Comparing and Contrasting Outpatient and Inpatient Providers’ Use of TelehealthMedicare: Coverage of Telehealth

Pathologist, Neurosurgeon, and Critical Care Specialist Face Criminal Charges in the Deaths of Dozens of Patients

Could local and federal prosecutors ask clinical laboratories to disclose information on their client physicians’ test-ordering activities when investigating medical errors?

Are physicians facing greater risk of criminal indictments when one of their patients dies, and investigators find that physician impairment or inappropriate medical treatments contributed to the patient’s death? Could clinical laboratories be drawn into federal investigations of their client physicians?

The healthcare industry is responding to often highly-publicized accusations of alleged wrongful care with extensive investigations of the doctors involved. And following suit, local and federal prosecutors increasingly seem willing to bring criminal charges against those physicians.

Thus, it behooves clinical laboratories to be aware of client physicians who may be over-ordering lab tests or regularly ordering inappropriate tests for their patients. At what point might criminal investigators hold medical laboratories accountable for not notifying authorities about lab test utilization patterns by physicians who could be reasonably understood to be putting their patients at risk of harm?

Doctors Charged in Three Cases Involving Deaths of Patients

In two separate reports, Fierce Healthcare covered three pending cases in which doctors are being charged in the deaths of their patients: article one covers a case is in Ohio; and article two covers cases in Arkansas and California. Charges were filed against:

  • William Husel, DO, an Ohio critical care specialist who was indicted for 25 counts of murder for allegedly intentionally ordering fatal drug overdoses, according to a statement by the Franklin County Prosecuting Attorney. He pleaded not guilty, the Associated Press reported.
  • Robert Levy, MD, an Arkansas pathologist who was indicted by a federal grand jury on “three counts of involuntary manslaughter” in the deaths of three patients, according to a statement by the US Attorney’s Office for the Western District of Arkansas. Levy pleaded not guilty at an arraignment in August, the Washington Post reported.  
  • Thomas Keller, MD, a California neurosurgeon who was indicted in the deaths of five patients, which allegedly resulted from his overprescribing opioids and narcotics, according to a statement from the State of California Department of Justice. Keller pleaded not guilty to second-degree murder charges in Sonoma County Court, according to the Press Democrat.
US Representative Bruce Westerman, R-Ark. (above) told the Washington Post, “Of all the medical professionals, the person you really don’t want messing up is a pathologist. If you have cancer, you want to know about it. If you don’t have it, you don’t want to be treated for it.” (Photo copyright: United States Congress.)

Dark Daily’s sister publication The Dark Report (TDR) covered the year-long investigation of Arkansas Pathologist Robert Levy, MD, by the US Attorney’s Office for the Western District of Arkansas. (See TDR, “Arkansas Pathologist Faces Three Manslaughter Charges,” September 30, 2019.)

Levy served as the Chief of Pathology and Laboratory Medical Services for the Veterans Health Care System of the Ozarks in Fayetteville, Ark., from 2005 through 2018.

In a statement, the US Attorney’s Office Western District of Arkansas said, “A federal grand jury … indicted Levy on twelve counts of wire fraud, twelve counts of mail fraud, four counts of making false statements in certain matters, and three counts of involuntary manslaughter.”  

A fact-finding panel interviewed Levy in 2015 after reports that he was under the influence of alcohol while on duty, stated the US Attorney Arkansas, adding that Levy denied the allegations.

In addition to other charges, the US Attorney Arkansas statement said, “The indictment charges Levy with three counts of involuntary manslaughter for causing the death of three patients through entering incorrect and misleading diagnoses and, on two occasions, by falsifying entries in the patients’ medical records to state that a second pathologist concurred with the diagnosis Levy had made. The indictment alleges that the incorrect and misleading diagnoses rendered by Levy caused the deaths of three veterans.”

In a news conference covered by the Washington Post, Duane Kees, US Attorney for the Western District of Arkansas, Department of Justice (DOJ), said, “I don’t think anyone would ever have imagined that a pathologist would use his knowledge and expertise to do something like this.”

Clinical laboratory leaders know how important it is to have quality processes to prevent misdiagnosis, mistakes, and inappropriate test utilization. Now, lab leaders may want to be aware of the activities of their client physicians as well.

During investigations involving harm to patients allegedly at the hands of healthcare providers, information kept by medical laboratories about the lab test ordering practices of their client physicians may become an important resource to officials conducting inquiries.

—Donna Marie Pocius

Related Information:

In California and Arkansas, Two Doctors Charged in Patient Deaths Over Opioid Prescriptions, Misdiagnosis

Ohio Doctor Charged with Murder in Deaths of 25 Hospitalized Patients

Attorney General Becerra Announces Arrest and Charges Against Santa Rosa Doctor

Santa Rosa Doctor Pleads Not Guilty to Murder Charges Connected to Four Patient Deaths

Dr. William S. Husel Indicted for 25 Counts of Murder in Mount Carmel Hospital Patient Deaths

Doctor Accused of Murder in 25 Patient Overdose Deaths

Fayetteville Doctor Arrested on Charges of Wire Fraud, Mail Fraud, Making False Statements, and Involuntary Manslaughter

Former VA Physician Charged with the Deaths of Three Veterans

Pathologist’s Errors Associated with Deaths at Arkansas VA

Pathologists Faces Three Manslaughter Charges

New Player in Market for Laboratory Information System Products Acquires Orchard Software

Sale of respected laboratory information system company may be an early sign that investors believe clinical laboratories and pathology groups are ready to upgrade their LISs and add needed capabilities

In the past 10 years there has been little disruption to the laboratory information systems (LIS) market that clinical laboratories and anatomic pathology groups use. Yet, over that same 10-year period, almost every hospital and physician group practice adopted an electronic health system (EHR), primarily because of federal financial incentives that encouraged such adoption.

For medical laboratories and pathology groups, this widespread—nearly universal—adoption of EHRs by the nation’s hospitals and physicians was disruptive. Labs were required to expend resources building digital interfaces to the EHRs of their parent hospitals and client physicians to support electronic test ordering and test reporting.

However, because that wave of EHR adoption is now over, clinical labs and pathology groups have an opportunity to assess the current state of the health information technology (HIT) that they use daily, primarily in the form of the classic laboratory information system that handles nearly all the primary functions needed to support testing and other operational needs.

This opportunity to help medical laboratories enhance and/or upgrade the capabilities of their laboratory information systems may be one motivation behind the recent sale of a well-known LIS company.

Private Equity Firm Buys Orchard Software

On Oct. 7, 2019, Orchard Software Corporation of Carmel, Ind., announced its acquisition by Franciscan Partners, a private equity firm based in San Francisco.

Orchard Software, founded in 1993, has grown steadily over the past 20 years, primarily by serving physician office laboratories, community hospital labs, and independent clinical laboratory companies. With each stage of growth, Orchard added functionality to its LIS and related software offerings and moved up-market to serve larger hospitals and larger labs.

The purchase price and the terms of the sale were not announced. Orchard’s Founder, President and CEO, Rob Bush, will retire. The new CEO is Billie Whitehurst, who came to Orchard from Netsmart Technologies, where she was Senior Vice President. The remainder of Orchard’s management team will be kept in place.

“Francisco Partners will provide capital and expertise to enable Orchard to grow at a faster pace and continue to develop its newer web-based products in an industry that has lagged behind in adoption of cloud-based software,” says Rob Bush (above), Orchard Software’s Founder and exiting CEO, in a press release. (Photo copyright: Twitter.)

Is the LIS Market Heating Up?

What makes the purchase of Orchard by a multi-billion-dollar private equity company noteworthy is the fact that it is the first significant transaction in the LIS sector probably since the mid-2000s, which saw several significant mergers and acquisitions.

During that period, Cerner Corporation (NASDAQ:CERN) purchased Siemens Health Services and Misys acquired Sunquest information Systems. Then, Roper Technologies purchased Sunquest Information Systems from Mysis. Roper later also acquired PowerPath, an anatomic pathology LIS owned by private equity company Thoma Bravo.

Other acquisitions or investments involving LIS companies need to happen before it would be appropriate to say that investor interest in the LIS sector is heating up. However, it is accurate to say that many professional investors will be watching to see whether Franciscan Partners succeeds with its investment in Orchard Software. If Orchard’s revenue and operating profits increase substantially in the next few years, that may encourage other investors to look for LIS companies and products that they can buy.

If this were to happen, that would be a positive development for both clinical laboratories and anatomic pathology groups, because these investors would have a motive to add new functions and capabilities to their LIS products. It would also wake up a sector of lab information technology that has been relatively quiet for several years.

—Michelle Robertson

Related Information:

Orchard Software Gains Boost from Francisco Partners

Orchard Software to Be Acquired by Private Equity Firm

Francisco Partners to Acquire Orchard Software

Francisco Partners, a Technology-Focused Private Equity Firm, Announced Sept. 30 Its Intent to Acquire Orchard Software

Elekta Sells Its PowerPath Pathology Software to Sunquest

Wellcome Sanger Institute Study Discovers New Strain of C. Difficile That Targets Sugar in Hospital Foods and Resists Standard Disinfectants

Researchers believe new findings about genetic changes in C. difficile are a sign that it is becoming more difficult to eradicate

Hospital infection control teams, microbiologists, and clinical laboratory professionals soon may be battling a strain of Clostridium difficile (C. difficile) that is even more resistant to disinfectants and other forms of infection control.

That’s the opinion of research scientists at the Wellcome Sanger Institute (WSI) and the London School of Hygiene and Tropical Medicine (LSHTM) in the United Kingdom who discovered the “genetic changes” in C. difficile. Their genomics study, published in Nature Genetics, shows that the battle against super-bugs could be heating up.

A WSI news release states the researchers “identified genetic changes in the newly-emerging species that allow it to thrive on the Western sugar-rich diet, evade common hospital disinfectants, and spread easily.”

Microbiologists and infectious disease doctors know full well that this means the battle to control HAIs is far from won.

C. difficile is currently forming a new species with one group specialized to spread in hospital environments. This emerging species has existed for thousands of years, but this is the first time anyone has studied C. difficile genomics in this way to identify it. This particular [bacterium] was primed to take advantage of modern healthcare practices and human diets,” said Nitin Kumar, PhD (above), in the news release. (Photo copyright: Wellcome Sanger Institute.) 

Genomic Study Finds New Species of Bacteria Thrive in Western Hospitals

In the published paper, Nitin Kumar, PhD, Senior Bioinformatician at the Wellcome Sanger Institute and Joint First Author of the study, described a need to better understand the formation of the new bacterial species. To do so, the researchers first collected and cultured 906 strains of C. difficile from humans, animals, and the environment. Next, they sequenced each DNA strain. Then, they compared and analyzed all genomes.

The researchers found that “about 70% of the strain collected specifically from hospital patients shared many notable characteristics,” the New York Post (NYPost) reported.

Hospital medical laboratory leaders will be intrigued by the researchers’ conclusion that C. difficile is dividing into two separate species. The new type—dubbed C. difficile clade A—seems to be targeting sugar-laden foods common in Western diets and easily spreads in hospital environments, the study notes. 

“It’s not uncommon for bacteria to evolve, but this time we actually see what factors are responsible for the evolution,” Kumar told Live Science.

New C. Difficile Loves Sugar, Spreads

Researchers found changes in the DNA and ability of the C. difficile clade A to metabolize simple sugars. Common hospital fare, such as “the pudding cups and instant mashed potatoes that define hospital dining are prime targets for these strains”, the NYPost explained.

Indeed, C. difficile clade A does have a sweet tooth. It was associated with infection in mice that were put on a sugary “Western” diet, according to the Daily Mail, which reported the researchers found that “tougher” spores enabled the bacteria to fight disinfectants and were, therefore, likely to spread in healthcare environments and among patients.

“The new C. difficile produces spores that are more resistant and have increased sporulation and host colonization capacity when glucose or fructose is available for metabolism. Thus, we report the formation of an emerging C. difficile species, selected for metabolizing simple dietary sugars and producing high levels or resistant spores, that is adapted for healthcare-mediated transmission,” the researchers wrote in Nature Genetics.

Bacteria Pose Risk to Patients

The findings about the new strains of C. difficile bacteria now taking hold in provider settings are important because hospitalized patients are among those likely to develop life-threatening diarrhea due to infection. In particular, people being treated with antibiotics are vulnerable to hospital-acquired infections, because the drugs eliminate normal gut bacteria that control the spread of C. difficile bacteria, the researchers explained.

According to the Centers for Disease Control and Prevention (CDC), C. difficile causes about a half-million infections in patients annually and 15,000 of those infections lead to deaths in the US each year.

New Hospital Foods and Disinfectants Needed

The WSI/LSHTM study suggests hospital representatives should serve low-sugar diets to patients and purchase stronger disinfectants. 

“We show that strains of C. difficile bacteria have continued to evolve in response to modern diets and healthcare systems and reveal that focusing on diet and looking for new disinfectants could help in the fight against this bacteria,” said Trevor Lawley, PhD, Senior Author and Group Leader of the Lawley Lab at the Wellcome Sanger Institute, in the news release.

Microbiologists, infectious disease physicians, and their associates in nutrition and environmental services can help by understanding and watching development of the new C. difficile species and offering possible therapies and approaches toward prevention.

Meanwhile, clinical laboratories and microbiology labs will want to keep up with research into these new forms of C. difficile, so that they can identify the strains of this bacteria that are more resistant to disinfectants and other infection control methods.  

—Donna Marie Pocius

Related Information:

Adaptation of Host Transmission Cycle During Clostridium Difficile Speciation

Diarrhea-causing Bacteria Adapted to Spread in Hospitals

Sugary Western Diets Fuel Newly Evolving Superbug

New Carb-Loving Superbug is Primed to Target Hospital Food

Superbug C Difficile Evolving to Spread in Hospitals and Feeds on the Sugar-Rich Western Diet

CDC: Healthcare-Associated Infections-C. Difficile  

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