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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?

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  

Might Clinical Laboratories Soon be Processing Tests That Predict Whether Patients Will Die in 5-10 Years?

Metabolic panels of 14 blood-based biomarkers that can predict when a patient is likely to die may be coming to a medical laboratory near you

Clinical pathologists soon may be able to predict when patients will die, thanks to a recent study that reveals new insights into how the human body works. Researchers at the Max Planck Institute for Biology of Ageing in Germany and the Leiden University Medical Center (LUMC) in the Netherlands revealed a metabolic panel of biomarkers that can more accurately predict death within five to 10 years than standard measures.

The researchers’ original goal was to find blood-based biomarkers that could show whether a person was vulnerable to death, particularly if that vulnerability was related to modifiable lifestyle factors.

The researchers published their study, titled, “A Metabolic Profile of All-Cause Mortality Risk Identified in an Observational Study of 44,168 Individuals,” in the journal Nature Communications last August.

Metabolic Biomarkers More Accurate than Current Health Measures

During their investigation, the researchers looked at 12 cohorts from previous studies and examined the results of 44,168 individuals between the ages of 18 and 109. In the follow-up to the study, 5,512 of the participants died.

In the introduction to their published study the researchers wrote, “We first determine which metabolic biomarkers independently associate with prospective mortality in all individuals. Subsequently, we test the association of the biomarkers with mortality in different age strata.”

The researchers then used the 14 biomarkers they identified to create a score that predicts mortality within five to 10 years.

The measures that most providers currently use to determine an elderly person’s overall health generally include blood pressure, heart rate, and functionality measures such as grip strength and gait. However, P. Eline Slagboom, PhD, LUMC Professor of Molecular Epidemiology and the study’s director, told The Scientist that those metrics are not always accurate methods for measuring health.

“For example, a somewhat higher weight, blood pressure, or cholesterol level is not as bad for individuals over 80 years of age as compared to younger individuals,” she said.

As it turned out, the traditional measures were significantly less accurate than the score Slagboom and her team developed. Traditional measures were accurate about 78% of the time, while the metabolic panel was accurate about 83% of the time, reported The Scientist. Additionally, the score based on metabolic biomarkers was accurate for people of all ages, rather than only among the young.

“As researchers on aging, we are keen to determine the biological age. The calendar age just doesn’t say very much about the general state of health of elderly people: one 70-year old is healthy, while another may already be suffering from three diseases. We now have a set of biomarkers which may help to identify vulnerable elderly people,” said P. Eline Slagboom, PhD (above), LUMC Professor of Molecular Epidemiology and the study’s director, in a statement. (Photo copyright: Max Planck Institute for Biology of Ageing.)

Study Yields Strong but Surprising Results

Researchers have studied biomarkers as predictive tools for quite some time, with only narrow success. The positive results of the Max Planck Institute/LUMC study even surprised those who worked on it. “We were surprised that the association of our biomarker score with mortality was so strong, given that it is only based on 14 metabolic markers in the blood measured at a single point in the life of individuals,” the study’s lead author Joris Deelen, PhD, a postdoctoral researcher at the Max Planck Institute for Biology of Ageing, said in The Scientist.

But though the results of the study are intriguing, some experts remain skeptical that a new biomarker for death has been found.

In reactions published by the Science Media Centre, an independent organization in the UK that promotes “the reporting of evidence-based science,” Kevin McConway, PhD, Emeritus Professor of Applied Statistics at The Open University wrote, “This is a solid and interesting piece of research. But it doesn’t go beyond investigating the plausibility of setting up a system for predicting risk of death, based on this type of data. It doesn’t claim to do more than that, and makes clear that there’s some way to go, in terms of research and analysis, until a risk prediction tool that’s useable in clinical work with patients might emerge.”

And in the same article, Amanda Heslegrave, PhD, a post-doctoral research associate and researcher at the UK Dementia Research Institute at the University College London wrote, “Whilst this study shows that this type of profiling can be useful, [the researchers] do point out importantly that it would need further work to develop a score at the individual level that would be useful in real life situations. We’d need to see: validation to ensure repeatability in different labs, production of reference samples to test this on an ongoing basis, work to make the individual score possible, validation in other cohorts and validation of all components of the panel. So, it’s an exciting step, but it’s not ready yet.”

Past Mortality Biomarker Studies

Other investigations into the use of biomarkers as a predictive tool have focused more narrowly on specific causes of death. For example, in 2008, the New England Journal of Medicine (NEJM) published a study titled, “Use of Multiple Biomarkers to Improve the Prediction of Death from Cardiovascular Causes.” The study concluded that using biomarkers and risk factors together “substantially improves the risk stratification for death from cardiovascular causes.”

Another study, from 2017, examined stress biomarkers, hospital readmission, and death. Published in the Journal of Hospital Medicine titled, “Association of Stress Biomarkers with 30-Day Unplanned Readmission and Death,” the researchers found that “stress biomarkers improved the performance of prediction models and therefore could help better identify high-risk patients.”

Other studies have examined the predictive possibilities of biomarkers in:

Even with all of the research into biomarkers, scientists are still a long way from having a clinical tool to predict death. However, according to Leo Cheng, PhD, Associate Biophysicist, Pathology and Radiology at Massachusetts General Hospital, and Associate Professor of Radiology at Harvard Medical School, the Max Planck study is on the right path.

The Scientist states that though Cheng believes the study doesn’t “prove anything,” he also notes that “using a score that combines the information from all 14 biomarkers is ‘the correct thing [to do]’ to provide a holistic look at metabolic pathways that may represent a person’s health.”

So, it might be awhile before clinical laboratories will be processing metabolic panels that return test results predicting a patient’s mortality within 10-15 years. Nevertheless, how medical labs would be involved in such testing is certainly something to think about.

—Dava Stewart

Related Information:

A Metabolic Profile of All-Cause Mortality Risk Identified in an Observational Study of 44,168 Individuals

Biomarkers Indicate Health in Old Age

Metabolic Biomarker “Score” May Predict Death in Next 5-10 Years

Expert Reaction to Study Looking at Mortality Associated Biomarkers in the Blood

Use of Multiple Biomarkers to Improve the Prediction of Death from Cardiovascular Causes

Association of Stress Biomarkers with 30-Day Unplanned Readmission and Death

Opioid Deaths: Trends, Biomarkers, and Potential Drug Interactions Revealed by Decision Tree Analysis

Dr. Christopher DeGiorgio: Sudden Unexpected Death in Epilepsy: Risk Factors, Biomarkers, and Prevention

Biomarkers to Predict Causes of Death in Atrial Fibrillation

Scientists in United Kingdom Manipulate DNA to Create a Synthetic Bacteria That Could Be Immune to Infections

Use of synthetic genetics to replicate an infectious disease agent is a scientific accomplishment that many microbiologists and clinical laboratory managers expected would happen

Microbiologists and infectious disease doctors are quite familiar with Escherichia coli (E. coli). The bacterium has caused much human sickness and even death around the globe, and its antibiotic resistant strains are becoming increasingly difficult to eradicate.

Now, scientists in England have created a synthetic “recoded” version of E. coli bacteria that is being used in a positive way—to fight disease. Their discovery is being heralded as an important breakthrough in the quest to custom-alter DNA to create synthetic forms of life that one day could be designed to fight specific infections, create new drugs, or produce tools to diagnose or treat disease.

Scientists worldwide working in the field of synthetic genomics are looking for ways to modify genomes in order to produce new weapons against infection and disease. This research could eventually produce methods for doctors—after diagnosing a patient’s specific strain of bacteria—to then use custom-altered DNA as an effective weapon against that patient’s specific bacterial infection.

This latest milestone is the result of a five-year quest by researchers at the Medical Research Council Laboratory of Molecular Biology (MRC-LMB) in Cambridge, England, to create a man-made version of the intestinal bacteria by redesigning its four-million-base-pair genetic code.

The MRC-LMB lab’s success marks the first time a living organism has been created with a compressed genetic code.

The researchers published their findings in the journal Nature.

Synthetic Genomics and Clinical Laboratories

Benjamin A. Blount, PhD, a postdoctoral research associate at Imperial College London, and Tom Ellis, PhD, Professor in Synthetic Genome Engineering at Imperial College London, praised the MRC-LMB team’s accomplishment in a subsequent Nature article.

“This is a landmark in the emerging field of synthetic genomics and finally applies the technology to the laboratory’s workhorse bacterium,” they wrote. “Synthetic genomics offers a new way of life, while at the same time moving synthetic biology towards a future in which genomes can be written to design.”

All known forms of life on Earth contain 64 codons—a specific sequence of three consecutive nucleotides that corresponds with a specific amino acid or stop signal during protein synthesis. Jason Chin, PhD, Program Lead at MRC-LMB, said biologists long have questioned why there are 20 amino acids encoded by 64 codons.

“Is there any function to having more than one codon to encode each amino acid?” Chin asked during an interview with the Cambridge Independent. “What would happen if you made an organism that used a reduced set of codons?”

The MRC-LMB research team took an important step toward answering that question. Their synthetic E. coli strain, dubbed Syn61, was recoded through “genome-wide substitution of target codons by defined synonyms.” To do so, researchers mastered a new piece-by-piece technique that enabled them to recode 18,214 codons to create an organism with a 61-codon genome that functions without a previously essential transfer RNA.

“Our synthetic genome implements a defined recoding and refactoring scheme–with simple corrections at just seven positions–to replace every known occurrence of two sense codons and a stop codon in the genome,” lead author Julius Fredens, PhD, a post-doctoral research associate at MRC, and colleagues, wrote in their paper.

Science Alert reports that the laboratory-created version of E. coli (above) “isn’t quite a dead ringer for its ancestor. The cells are a touch longer, and they reproduce 1.6 times slower. But the edited E. coli seems healthy and produces the same range and quantity of proteins as the non-edited versions.” (Photo copyright: Jason Chin/STAT.)

Joshua Atkinson, PhD, a postdoctoral research associate at Rice University in Houston, labeled the breakthrough a “tour de force” in the field of synthetic genomics. “This achievement sets a new world record in synthetic genomics by yielding a genome that is four times larger than the pioneering synthesis of the one-million-base-pair Mycoplasma mycoides genome,” he stated in Synthetic Biology.

“Synthetic genomics is enabling the simplification of recoded organisms; the previous study minimized the total number of genes and this new study simplified the way those genes are encoded.”

Manmade Bacteria That are Immune to Infections

Researchers from the J. Craig Venter Institute in Rockville, Maryland, created the first synthetic genome in 2010. According to an article in Nature, the Venter Institute successfully synthesized the Mycoplasma mycoides genome and used it “reboot” a cell from a different species of bacterium.

The MRC-LMB team’s success may prove more significant.

“This new synthetic E. coli should not be able to decode DNA from any other organism and therefore it should not be possible to infect it with a virus,” the MRC-LMB stated in a news release heralding the lab’s breakthrough. “With E. coli already being an important workhorse of biotechnology and biological research, this study is the first time any commonly used model organism has had its genome designed and fully synthesized and this synthetic version could become an important resource for future development of new types of molecules.”

Because the MRC-LMB team was able to remove transfer RNA and release factors that decode three codons from the E. coli bacteria, their achievement may be the springboard to designing manmade bacteria that are immune to infections or could be turned into new drugs.

“This may enable these codons to be cleanly reassigned and facilitate the incorporation of multiple non-canonical amino acids. This greatly expands the scope of using non-canonical amino acids as unique tools for biological research,” the MRC-LMB news release added.

Though synthetic genomics impact on clinical laboratory diagnostics is yet to be known, medical laboratory leaders should be mindful of the potential for rapid innovation in this field as proof-of-concept laboratory innovations are translated into real-world applications.

—Andrea Downing Peck

Related Information:

Scientists Redesigned an Entire Genome to Create the Most Synthetic Life Form Yet

World’s First Synthetic Organism with Fully Recoded DNA Is Created at MRC LMB in Cambridge

Creating an Entire Bacterial Genome with a Compressed Genetic Code

Total Synthesis of Escherichia Coli with a Recoded Genome

Construction of an Escherichia Coli Genome with Fewer Codons Sets Records

Life Simplified: Recompiling a Bacterial Genome for Synonymous Codon Compression

Creation of a Bacterial Cell Controlled by a Chemically Synthesized Genome

Cambridge University Researchers Recode E. Coli DNA to Create Living, Reproducing Bacteria with Entirely Synthetic DNA

Clinical Laboratory Leaders Agree: Showing Value Is More Important than Ever as Healthcare Transitions Away from Fee-for Service Reimbursement

How medical laboratories can show value through process improvement methods and analytics will be among many key topics presented at the upcoming Lab Quality Confab conference

Quality management is the clinical laboratory’s best strategy for surviving and thriving in this era of shrinking lab budgets, PAMA price cuts, and value-based payment. In fact, the actions laboratories take in the next few months will set the course for their path to clinical success and financial sustainability in 2020 and beyond.

But how do medical laboratory managers and pathologists address these challenges while demonstrating their lab’s value? One way is through process improvement methods and another is through the use of analytics.

Clinical pathologists, hospital lab leaders, and independent lab executives have told Dark Daily that the trends demanding their focus include:

  • Ensuring needed resources and appropriate tests, while the lab is scrutinized by insurance companies and internally by hospital administration;
  • PAMA’s (Protecting Access to Medicare Act of 2014) effects on reimbursement;
  • Consumers’ demand for lower cost and better access to quality healthcare;
  • Serving patients in a wider continuum of care; and
  • Collaborating instead of competing with other labs in the market.

“The laboratory and resources we are given are being scrutinized in a different way than they have been historically,” said Christopher Doern, PhD, Director of Microbiology and Associate Professor of Pathology, Virginia Commonwealth University Health System (VCU Health) Medical College of Virginia, Richmond, in an exclusive interview with Dark Daily.

“Our impact on patient care, in many cases, is very indirect. So, it is difficult to point to outcomes that occur. We know things we do matter and change patient care, but objectively showing that is a real struggle. And we are being asked to do more than we ever had before, and those are the two big things that keep me up at night these days,” he added.

This is where process improvement methods and analytics are helping clinical laboratories understand critical issues and find opportunities for positive change.

“You need to have a strategy that you can adapt to a changing landscape in healthcare. You have to use analytics to guide your progress and measure your success,” Patricia Nortmann, System Director of Laboratory Services at St. Elizabeth Healthcare, Erlanger, Ky., told Dark Daily.

Clinical Laboratories Can Collaborate Instead of Compete

Prior to a joint venture with TriHealth in Cincinnati, St. Elizabeth lab leaders used data to inform their decision-making. Over about 12 years preceding the consolidation of labs they:

  • Centralized the outreach core lab;
  • Installed front-end automation in chemistry;
  • Standardized the laboratory information system (LIS) and analyzer platforms across five affiliate hospitals; and
  • Implemented front-end automation outside the core area and in the microbiology lab.

“We are now considered a regional reference lab in the state of Kentucky for two healthcare organizations—St. Elizabeth and TriHealth,” Nortmann said. 

Thanks to these changes, the lab more than doubled its workload, growing from 2.1 million to 4.3 million outreach tests in the core laboratory, she added.

Christopher Doern, PhD (left), Director of Microbiology and Associate Professor of Pathology at Virginia Commonwealth University Health System; Patricia Nortmann (center), System Director of Laboratory Services at St. Elizabeth Healthcare; and Joseph Cugini (right), Manager Client Solutions at Health Network Laboratories, will present practical solutions and case studies in quality improvement and analytics for clinical laboratory professionals at the 13th Annual Lab Quality Confab, October 15-16, 2019, at the Hyatt Regency in Atlanta, Ga. (Photo copyright: The Dark Report.)

Using Analytics to Test the Tests

Clinical laboratories also are using analytics and information technology (IT) to improve test utilization.

At VCH Health, Doern said an analytics solution interfaces with their LIS, providing insights into test orders and informing decisions about workflow. “I use this analytics system in different ways to answer different questions, such as:

  • How are clinicians using our tests?
  • When do things come to the lab?
  • When should we be working on them? 

“This is important for microbiology, which is a very delayed discipline because of the incubation and growth required for the tests we do,” he said.

Using analytics, the lab solved an issue with Clostridium difficile (C diff) testing turnaround-time (TAT) after associating it with specimen transportation.

Inappropriate or duplicate testing also can be revealed through analytics. A physician may reconsider a test after discovering another doctor recently ordered the same test. And the technology can guide doctors in choosing tests in areas where the related diseases are obscure, such as serology.  

Avoiding Duplicate Records While Improving Payment

Another example of process improvement is Health Network Laboratories (HNL) in Allentown, Pa. A team there established an enterprise master patient index (EMPI) and implemented digital tools to find and eliminate duplicate patient information and improve lab financial indicators.

“The system uses trusted sources of data to make sure data is clean and the lab has what it needs to send out a proper bill. That is necessary on the reimbursement side—from private insurance companies especially—to prevent denials,” Joseph Cugini, HNL’s Manager Client Solutions, told Dark Daily

HNL reduced duplicate records in its database from 23% to under one percent. “When you are talking about several million records, that is quite a significant improvement,” he said.

Processes have improved not only on the billing side, but in HNL’s patient service centers as well, he added. Staff there easily find patients’ electronic test orders, and the flow of consumers through their visits is enhanced.

Learn More at Lab Quality Confab Conference

Cugini, Doern, and Nortmann will speak on these topics and more during the 13th Annual Lab Quality Confab (LQC), October 15-16, 2019, at the Hyatt Regency in Atlanta, Ga. They will offer insights, practical knowledge, and case studies involving Lean, Six Sigma, and other process improvement methods during this important 2-day conference, a Dark Daily news release notes.

Register for LQC, which is produced by Dark Daily’s sister publication The Dark Report, online at https://www.labqualityconfab.com/register, or by calling 512-264-7103.   

—Donna Marie Pocius

Related Information:

13th Annual Lab Quality Confab October 15-16, 2019. Hyatt Regency, Atlanta, Ga.

Clinical Laboratory Innovators in Lean, Six Sigma, and Process Improvement to Gather in Atlanta October 15-16, 2019

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