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.”
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.
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.”
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.
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.
A recent LIS market report shows that demand for a modern LIS is driven by a number of factors: acceleration of laboratory automation, the need for improved lab efficiency, advances in integrated functionality, importance of compliance with regulatory requirements, and the rising prevalence of chronic diseases.
Indeed, because all laboratories are now routinely being asked to do more with less, these and numerous other urgent reasons are compelling independent and hospital laboratories to invest resources in a major laboratory information implementation or upgrade.
Dark Daily is pleased to offer a new FREE White Paper providing practical insights and indispensable how-to’s regarding the enormous challenges associated with installing, converting, and interfacing a laboratory information system. This paper, written by an expert who has experienced (and overcome) these challenges, outlines for you a multi-step plan for bringing your laboratory team together toward the common goal of a modern LIS, thus expanding your lab’s capabilities, ensuring efficient operations, and yielding quality improvement.
This White Paper specifically addresses:
Questions to ask when researching a laboratory information system
Finding the right project manager who will mesh well with your laboratory and put into place the steps necessary to make your LIS installation or conversion a success
Building a realistic budget for your project, including important considerations not directly related to your implementation
Events important to include in your project plan that are often overlooked
Reasons, many not obvious, for eliminating as many variables, non-essential tasks, and complicated workflows as possible—pre go-live
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Table of Contents
Introduction
Part 1: Components of a Clinical Laboratory Information System Implementation
Phase 1: Project Initiation, LIS Preparation, Gap Analysis, and New Software
Phase 2: Installing the Laboratory Information System, Configuration, Data, Interfaces
PART 2: Critical LIS Testing and Parallels: Can We Achieve a ‘Non-Event’ at LIVE?
Phase 3: Laboratory Information System Testing and Training
Phase 4: Laboratory Information System LIVE and Support
Key Takeaways
The right LIS is key to your laboratory’s quality operations. And when it comes to LIS installations, conversions, and interface projects, there are a multitude of issues to consider. Achieving the successful implementation will not only streamline your laboratory processes, it will also provide the added benefits of improved staff morale and stronger relationships with your clients and investors.
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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.
A recent LIS market report shows that demand for a modern LIS is driven by a number of factors: acceleration of laboratory automation, the need for improved lab efficiency, advances in integrated functionality, importance of compliance with regulatory requirements, and the rising prevalence of chronic diseases.
