CAP president maintains medical laboratory staff are ‘indispensable’ in pandemic fight and should be in ‘top tier’ for vaccination
As COVID-19 vaccinations continue to roll out, the College of American Pathologists (CAP) is lobbying for clinical pathologists and medical laboratory staff to be moved up the priority list for vaccinations, stating they are “indispensable” in the pandemic fight.
In a news release, CAP’s President Patrick Godbey, MD, FCAP argued for the early vaccination of laboratory workers, “It is essential that early access to the vaccine be provided to all pathologists and laboratory personnel,” he said. “Pathologists have led throughout this pandemic by bringing tests for the coronavirus online in communities across the country and we must ensure that patient access to testing continues. We must also serve as a resource to discuss the facts about the vaccine and answer questions patients, family members, and friends have about why they should get the vaccine when it is available to them.”
In a phone call following a virtual press conference, pathologists and CAP President Patrick Godbey, MD (above), told MedPage Today that even if medical laboratory staff are not directly in contact with patients, they should be considered “top tier” (designated as Phase 1a) for getting the vaccine. “I think they [clinical laboratory workers] should be considered in the same tier as nurses,” said Godbey, who also is Laboratory Director at Southeastern Pathology Associates and Southeast Georgia Health System in Brunswick, Ga. “They’re indispensable. Without them, there’d be no one to run the tests.” (Photo copyright: Southeast Georgia Health System.)
Who Does CDC Think Should Be First to Be Vaccinated?
According toThe New York Times (NYT), there are an estimated 21 million healthcare workers in the United States, making it basically “impossible,” the NYT wrote, for them all to get vaccinated in the first wave of COVID-19 vaccinations.
A December 11, 2020, CDC Morbidity and Mortality Weekly Report, titled, “ACIP Interim Recommendation for Allocating Initial Supplies of COVID-19 Vaccine—United States, 2020,” notes that “The [federal] Advisory Committee on Immunization Practices (ACIP) recommended, as interim guidance, that both 1) healthcare personnel and 2) residents of long-term care facilities be offered COVID-19 vaccine in the initial phase of the vaccination program.”
The ACIP report defines healthcare personnel as “paid and unpaid persons serving in healthcare settings who have the potential for direct or indirect exposure to patients or infectious materials.”
However, a CDC terminology guidance document listed at the bottom of the ACIP report states, “For this update, HCP [Healthcare Personnel] does not include dental healthcare personnel, autopsy personnel, and laboratory personnel, as recommendations to address occupational infection prevention and control (IPC) services for these personnel are posted elsewhere.”
In part, the letter stated, “We are convinced that ACIP did not intend to exclude any healthcare workers from its recommendation to offer vaccinations to healthcare personnel in the initial phase of the COVID-19 vaccination program (Phase 1a). However, we would hate for jurisdictions to overlook dental, autopsy, and laboratory personnel because of a minor footnote in [CDC] guidance that was developed for an entirely different purpose (i.e., infection control).
“We respectfully ask CDC to clarify,” the letter continues, “… that all healthcare workers—including dental, autopsy, and laboratory personnel—are among those who should be given priority access to vaccine during the initial phase of the COVID-19 vaccination program.”
“In the laboratory, they are encountering and handling thousands of samples that have active live virus in them,” said Karger, who called clinical laboratory staff and phlebotomists the “forgotten” frontline healthcare workers. “We’re getting 10,000 samples a day. That’s a lot of handling of infectious specimens, and we do want [staff] to be prioritized for vaccination.”
Karger continued to stress the vital role clinical laboratories play not only in COVID-19 testing but also in the functioning of the overall health system. She added that staff burnout is a concern since laboratory staff have been working “full throttle” since March.
“From an operational standpoint, we do need to keep our lab up and running,” she said. “We don’t want to have staff out such that we would have to decrease our testing capacity, which would have widespread impacts for our health system and state.”
Testing for Post-Vaccine Immunity
The CAP panelists also highlighted the need to prepare for the aftermath of widespread COVID-19 vaccinations—the need to test for post-vaccine immunity.
“It’s not routine practice to check antibody levels after getting a vaccine but given the heightened interest in COVID testing, we are anticipating there is going to be some increased in demand for post-vaccine antibody testing,” Karger said. “We’re at least preparing for that and preparing to educate our providers.”
Karger pointed out that clinical pathologists will play an important role in educating providers about the type of antibody tests necessary to test for COVID-19 immunity, because, she says, only the SARS-CoV-2 spike protein antibody test will check for an immune response.
With the pandemic expected to stretch far into 2021, clinical laboratories will continue to play a crucial role in the nation’s healthcare response to COVID-19. As essential workers in the fight against infectious disease, clinical pathologists, clinical chemists, and all medical laboratory staff should be prioritized as frontline healthcare workers.
As demand for SARS-CoV-2 coronavirus testing increases, leaders of the College of American Pathologists meet online to brainstorm possible solutions to the crisis
In September, the College of American Pathologists (CAP) began its series of “virtual media briefings” given by leading pathologists and physicians at the forefront of COVID-19 testing which are designed to “offer insights and straight talk” on the crisis confronting today’s clinical laboratories.
During the third virtual meeting on December 9, presenters discussed how the ever-increasing demand for COVID-19 testing has placed an enormous amount of stress on clinical laboratories, medical technologists (MTs), and clinical laboratory scientists (CLSs) responsible for processing the high volume of SARS-CoV-2 tests, and on the supply chains medical laboratories depend on to receive and maintain adequate supplies of testing materials.
“As soon as we get one set of supplies, then it’s another set of supplies that we can’t get our hands on,” said Christine Wojewoda, MD, Clinical Pathologist and Associate Professor at the University of Vermont Medical Center, during the third CAP virtual briefing. “Right now, we’re very concerned that our lab can’t get pipette tips that have a certain filter in them to transfer patient samples into the tubes that we need, or the plates that we need to do the testing. If we can’t get the patient sample into where it needs to go, safely, without contaminating other patient samples, that’s a big issue.”
Other members of the CAP panel concurred with Wojewoda and indicated that their clinical labs also are encountering supply chain challenges.
“It’s a daily battle,” said Amy Karger, MD, PhD, Clinical Pathologist and Associate Professor at University of Minnesota Physicians. “One of our managers spends hours a day making sure our lab has enough supplies, plastics, and chemicals to do the testing that we want to do. And he is often having to look for alternative solutions for COVID-19 testing, making phone calls, trying to find alternative products, and so we have a consistent worry about that.”
A June survey of CAP-accredited laboratories for COVID-19 testing found that more than 60% of lab directors reported difficulties in procuring critical supplies needed to conduct COVID-19 testing. The respondents indicated they encountered substantial barriers to obtaining equipment needed for SARS-CoV-2 testing—particularly test kits (69%), swabs (66%), and transport media (62%).
Staff Burnout and Shortages at Many Medical Laboratories
Karger also indicated that she is concerned about staff burnout and the toll the workload is taking on medical technologists at her laboratory.
“Lab staff have been working full throttle since March. I think that is often lost on people. They kind of assumed that when cases were low with COVID-19, that maybe the lab staff got a break. Well, that wasn’t the case,” she stated, adding, “They [the medical technologists] were planning for this surge that we’re experiencing now and have been working often seven days a week, double shifts to get us to this point of high testing capacity [to respond to the demand for COVID-19 testing].”
Another member of the CAP panel echoed Karger’s concerns.
“We worry about that as well,” said Patrick Godbey, MD, Founder and Laboratory Director at Southeastern Pathology Associates and current CAP President. “This demand for COVID-19 testing has made an already bad situation worse because there’s an absolute shortage of medical laboratory personnel and the increased demands on clinical labs have made this shortage even more acute.”
Almost all of the surveyed CAP-accredited laboratories reported losses in revenue and financial stress since the pandemic started. But few had applied for any of the available funds offered through federal assistance programs. The survey found that the top issues among pathologists reported by laboratory directors were:
reduced work hours (72%),
reductions in pay (41%),
increased burnout (21%), and
increased work hours (20%).
According to the survey, the top stresses affecting non-pathologist professionals working in clinical labs were:
The diminishing labor pool trained for COVID-19 testing—coupled with high stress/burnout among existing staff—is a major impediment to ongoing expansion in the daily number of molecular COVID-19 tests that can be performed by the nation’s labs.
Also, the already-tight supply of med techs means many metropolitan area labs—particularly hospital labs—are operating with just 75% of the number of staff they are authorized to hire, because there are no techs available. Thus, existing staff are working lots of overtime, and vacant FTE positions are being temporarily filled by MTs placed by employment agencies.
A New York Times (NYT) article in December, titled, “‘Nobody Sees Us’: Testing-Lab Workers Strain Under Demand,” revealed that testing teams across the country are dealing with “burnout, repetitive-stress injuries, and an overwhelming sense of doom.” The article reported on the shortages of supplies needed to perform testing and states there is a “dearth of human power” in the field of pathology as well.
The supply of MTs and CLSs, molecular PhDs, clinical pathologists, MLTs, and other laboratory scientists available to work in the nation’s labs is finite and training programs take years to produce qualified workers to perform laboratory testing.
In the NYT article, microbiologist Karissa Culbreath, PhD (above), Scientific Director, Infectious Diseases at TriCore Reference Laboratories, and Assistant Professor of Pathology at the University of New Mexico, said that when shortages arise, “there are workarounds for almost everything else, but people are irreplaceable.” In addition to the large volume of COVID-19 tests that labs are expected to perform, they also must keep up with the other tests that are sent to them for analysis. Some facilities are even transitioning to 24/7 testing to keep up with the demand. “Labs are trying to maintain our standard of operation with everything else, with a pandemic on top of it,” said Culbreath. (Photo copyright: KOB 4/NBC.)
Should Clinical Lab Workers Be First to Receive the COVID-19 Vaccine?
In the third CAP virtual media briefing, the panel suggested that medical laboratory workers should be among the first to receive the COVID-19 vaccine.
“They are encountering and handling thousands of samples that have active live virus in them,” Karger said. “We are getting 10,000 samples a day [for SARS-CoV-2 testing]. That’s a lot of handling of infectious specimens and we do want them to be prioritized for vaccination.”
She added, “From an operational standpoint, we need to keep our lab up and running. We don’t want to have staff out such that we would have to decrease our SARS-CoV-2 testing capacity, which would have widespread impact on our health system and our state.”
Since the pandemic began nearly a year ago, there have been more than 18 million cases of COVID-19 confirmed in the US and more than 300,000 people have died from the virus, according to data from the federal Centers for Disease Control and Prevention (CDC).
And, as we move into flu season, the number of new COVID-19 cases is reportedly increasing, which adds more stress to clinical laboratories and their supply chains. As this is unlikely to end anytime soon, clinical lab managers must find new ways to do more with less.
Because of ‘shelter in place’ orders, many anatomic pathologists are reviewing digital images from home during the COVID-19 outbreak and demonstrating the value of whole slide imaging, digital pathology, and CMS’ recent amended remote sign-out policy
COVID-19 is already triggering many permanent changes in the way healthcare is organized and delivered in the United States. However, not until the SARS-CoV-2 pandemic eases will the full extent of these changes become visible. This will be particularly true for anatomic pathology and the profession’s expanded use of telepathology, digital pathology, and whole-slide imaging.
Since early March, specimen referrals and revenues have collapsed at anatomic pathology groups and laboratories across the nation. Dark Daily’s sister publication, The Dark Report (TDR), was first to quantify the magnitude of this collapse in tissue referrals to pathology groups. In an interview with The Dark Report, Kyle Fetter, Executive Vice President and General Manager of Diagnostic Services at XIFIN, Inc., explained that pathology clients using XIFIN’s revenue cycle management services were seeing an average 40% decrease in specimens. And, for certain pathology sub-specialties, the drop-off in specimen referrals was as much as 90%. (See TDR, “From Mid-March, Labs Saw Big Drop in Revenue,” April 20, 2020.)
The College of American Pathologists (CAP) appealed to the Centers for Medicare and Medicaid Services (CMS) to allow pathologists to work remotely. In response, CMS issued a memorandum which stated, “Due to the public health emergency posed by COVID-19 and the urgent need to expand laboratory capacity, CMS is exercising its enforcement discretion to adopt a temporary policy of relaxed enforcement in connection with laboratories located at temporary testing sites under the conditions outlined herein.”
Since then, many physicians, including pathologists, have quickly adapted to working remotely in some form.
Push for Remote Pathology Services Acknowledges Anatomic Pathologist Shortage
The CMS memorandum (QSO-20-21-CLIA), which the federal agency issued to laboratory surveyors on March 26, 2020, notes that CMS will exercise “enforcement discretion to ensure pathologists may review pathology slides remotely” if certain defined conditions are met.
CMS’ decision, which “is applicable only during the COVID-19 public health emergency,” is intended to increase capacity by allowing remote site review of clinical laboratory data, results, and pathology slides.
Ordinarily, CLIA regulations for cytology (a branch of study that focuses on the biological structure of cells) state that cytology slide preparations must be evaluated on the premises of a laboratory that is certified to conduct testing in the subspecialty of cytology. However, a fast-acting Congressional letter sent by 37 members of Congress to US Department of Health and Human Services (HHS) Secretary Alex Azar II, MD, states, “it is unwise and unnecessary to overburden the remaining pathologists with excess work due to staffing shortages, thereby increasing the risk of burnout, medical error, and further shortages in staffing due to exposure. The number of COVID-19 cases will increase and peak over the next two months and will stretch existing healthcare systems to their limits.”
Decreasing Number of ‘Active Pathologists’ Drives Adoption of Telepathology, Digital Pathology, and Whole-slide Imaging
The current COVID-19 outbreak is just the latest factor in support of enabling remote review of anatomic pathology images and cases. The trend of using telepathology, whole-slide imaging (WSI), and digital pathology systems has been gathering momentum for several years. Powerful economic forces support this trend.
The Dark Report devoted its June 10, 2019, issue to a deep dive of the challenges currently facing the anatomic pathology profession. In particular, TDR noted a study published May 31, 2019, in the Journal of the American Medical Association (JAMA) Network Open, titled, “Trends in the US and Canadian Pathologist Workforces from 2007 to 2017.” The study’s authors—pathologists in the United States and Canada—reported that between 2007 and 2017 the number of active pathologists in the United States decreased from 15,568 to 12,839—a 17.53% decline.
TDR noted that these findings imply there are fewer pathologists in the United States today in active practice to handle the steady increase in the number of cases requiring diagnostic review. In turn, this situation could lead to delays in diagnoses detrimental to patient care.
In the United States, the COVID-19 pandemic created an “immediate need for remote sign-outs, reviews, and consults,” said Mike Bonham, MD, PhD (above), Chief Medical Officer for Proscia, a digital pathology software developer, in an interview with Dark Daily. “In the context of highly relevant workflow and workforce challenges, it reinforces the opportunity for wider adoption of digital pathology.” Prior to the outbreak of COVID-19, several distinct forces were driving adoption and use of digital pathology in combination with traditional microscopy, he said. (Photo copyright: Proscia.)
Distinct Forces Beginning to Reshape Anatomic Pathology
In recent years, the anatomic pathology profession has faced growing financial pressure, a shrinking workforce, and a surge in the global demand for pathology—issues that come at a time when biopsies and cancer diagnostics require greater expertise.
The UCSF School of Medicine started with frozen slide sections and moved to the broader volume of pathology slides. Since 2015, UCSF’s School of Medicine has moved toward a fully digital pathology operation and has serialized the adoption by specialty, according to Zoltan Laszik, MD, PhD, attending physician at UCSF and Professor of Clinical Pathology in UCSF’s Departments of Pathology and Laboratory Medicine.
Laszik is among a handful of specialists and digital pathology early adopters who collaborated on the new Dark Daily white paper, which is available for free download.
Through the adoption of digital pathology, glass slides are digitized using a whole-slide image scanner, then analyzed through image viewing software. Although the basic viewing functionality is not drastically different than that provided by a microscope, digitization does bring improvements in lab efficiency, diagnostic accuracy, image management, workflows, and revenue enhancements.
Additionally, artificial intelligence (AI)-based computational applications have emerged as an integral part of the digital pathology workflow in some settings, the white paper explains.
“These developments are important to anatomic pathologists because the traditional pathology business model continues to transform at a steady pace,” noted Robert L. Michel, Editor-in-Chief of The Dark Report.
Anthony Magliocco, MD, FRCPC, FCAP, President and CEO of Protean BioDiagnostics and former Professor and Chair of Pathology at Moffitt Cancer Center, is featured in the white paper as well. His new pathology service model provides routine pathology services, precision oncology, second opinions, liquid biopsies, genetics, and genomics to cancer centers from a Florida-based specialty laboratory.
To register for this important learning opportunity, click here or place this URL in your web browser: https://www.darkdaily.com/webinar/streamlined-operations-increased-revenue-higher-quality-of-care-conclusive-evidence-on-the-value-of-adopting-digital-pathology-in-your-lab/.
These digital pathology technologies represent an innovative movement shaping the present and future of pathology services. Pathologists wanting to learn more are encouraged to sign up for the May 13 webinar, which will build on the body of evidence and commentary that is included in the new white paper, and which will be available for free on-demand download following the live broadcast.
Savvy medical laboratory managers conduct internal audits of processes involved in deficiency citations so they can uncover how deficiencies occur and help eliminate recurrences
One trend that places clinical laboratories at risk involves increased regulation of lab processes, along with more thorough accreditation inspections. Compared to past years, both developments mean more ways for lab assessors to find greater numbers of deficiencies.
However, leading laboratory accreditation and quality improvement experts say that many deficiencies could be avoided if lab leaders conducted their own internal audits and continuous quality improvement projects ahead of visits by accrediting authorities.
In an exclusive interview with Dark Daily, Randall Querry, Director of Government Relations at the American Association for Laboratory Accreditation (A2LA) said, “Clinical laboratories can do a better job of preparing for the external assessment by doing an internal audit. That is, watching personnel perform tests and noting if they aren’t following the same sequences that standard operating procedures address before the external assessors arrive.”
“This doesn’t have to be an ‘us against them’ exercise. We are
all in this together for continual improvement and to ensure we’re doing a
better job at the end of each day—that we have had a win,” said Querry
said.
How Should Clinical Laboratories Conduct Internal Audits?
So, what is the best method for clinical laboratory leaders to
conduct their own audits of operations and avoid citations of deficiencies?
Lucia Berte, President of Laboratories Made Better, suggested medical laboratories should “Pick a sequence and follow it through.” In the Dark Daily interview, she suggested labs should focus on:
The sequence of receiving samples in the
laboratory to make certain they are properly accessioned, processed, and
distributed;
Steps to setting up and running an analyzer; and
The process of ensuring tests’ critical values
are reported to ordering clinicians and how reports are made.
An internal audit may suggest areas where the clinical lab
is not on target to meet regulatory and accreditation criteria. Or, the lab may
discover what Querry calls “gray areas”—places where criteria are currently
being met, but a trend suggests there could be problems down the road.
“And in those cases, it’s always good to identify areas of
improvement for preventative action. They may not be a top priority—such as a
deficiency—but the areas are on the radar screen as something to address to prevent
it becoming a worsening problem,” Querry said.
Quality Improvement Processes to Address Deficiencies
Berte notes that citations in one area of the lab may
suggest the need for continuous improvement projects across all laboratory
departments or sections. For example, an accrediting body may cite chemistry
for a deficiency while hematology and other departments do okay. However, that
determination can be deceiving.
“There is always an underlying process. And the better
question for the clinical laboratory is ‘can we make an improvement project out
of this that can solve this problem not only for the area where it was cited,
but perhaps prevent this problem from occurring in other lab [departments]
prior to the next external accreditation assessments?’” Berte said.
Lack of Uniformity among a Clinical Laboratory’s
Departments
Berte says a common deficiency is “lack of a uniform
competency assessment program” for staff throughout the lab. Assessors expect
laboratory departments to have the same competency assessment in regard to
processes, records, and the way documents are created, she explained.
Lucia Berte (above), President of Laboratories Made Better, advises improving quality of documents as a project across the entire lab. “We still have a lot of silo-mentality in labs—where chemistry is different from hematology which is different from transfusion. Labs should have a uniform approach to the way their documents are written, and this is not necessarily the case,” she told Dark Daily. (Photo copyright: Whitehat Communications.)
Competency-related Citations
Berte also said competency-related citations may happen when
documents read by auditors are not in sync with what the officials see in the clinical
lab during inspections. “People not doing things in the order in which things
have to happen. That’s the disconnect.”
Querry, speaking from the perspective of an assessor, adds,
“We see a discrepancy and ask—do they have the appropriate work procedures with
them at the workstation? Is it accessible? Where is this discrepancy? We
identify it and then it’s up to the lab to address it—in training, and between
the written procedure and the process.”
Consistency, he says, is important especially in
organizations where staff rotate among lab areas and different shifts.
Quality System Essentials for Clinical Laboratories
The website for the Clinical and Laboratory Standards Institute (CLIA) states that implementing a quality management system in the lab involves use of “quality system essentials (QSEs).” QSEs are key to lab workflow, communication, and training. They include documents and records management, assessments, and continual improvement.
Querry emphasizes that trying to predict what the hot citations may be in 2020 is not as important as focusing on the technical competence of the lab and its resources.
“We are not out to play gotcha. We are going in there, looking
at all the systems, and doing a sampling of testing in various departments of
the lab. It’s up to the lab to show us it is technically competent to perform
those tests. And they have the equipment and records that the equipment has
been checked and calibrated and maintained. We have an examination process,” he
said.
Experts agree, clinical laboratories that prepare for
external assessments with internal audits and continuous improvement programs
may reduce deficiencies during inspections.
Fawning media coverage Theranos’ blood-test claims ended once experts spoke out, showing the importance of strong relationships between pathologist and journalists
Wall Street Journal (WSJ) reporter John Carreyrou’s investigation into former Silicon Valley darling Theranos is credited with turning the spotlight on the blood-testing company’s claims and questionable technology. However, Carreyrou’s investigation may never have happened without the assistance of Missouri pathologist Adam Clapper, MD, who tipped off the reporter to growing skepticism about Theranos’ finger-stick blood testing device.
Clapper’s involvement in Theranos’ fall from grace provides
a lesson on why anatomic
pathologists, clinical
pathologists, and other medical
laboratory leaders should cultivate strong working relationships with
healthcare journalists who seek out expert sources when covering lab-related
issues.
Dark Daily has written extensively about Theranos—once valued at nine billion dollars—and its founder and former CEO Elizabeth Holmes, whose criminal trial on nine counts of wire fraud and two counts of conspiracy to commit wire fraud is scheduled to begin this summer, noted the WSJ.
In 2018, Holmes and former Theranos President Ramesh “Sunny” Balwani settled a civil case with the Securities and Exchange Commission (SEC). Holmes agreed to pay a $500,000 penalty and relinquished control of Theranos. She also was barred from serving as Director of a public company for 10 years.
Theranos Investigation Would Not Have Occurred without
Clapper
Holmes founded Theranos in 2003 when she was 19 years old.
By 2013, Holmes had become a media sensation based on her claims that Theranos
had developed a medical technology that could run thousands of clinical
laboratory tests using the blood from a tiny finger-prick. And, she claimed, it
could do so quickly and cheaply.
By 2015, Carreyrou’s exposé in theWall Street Journal revealed Theranos’ massive deceptions and questionable practices. His series of stories kickstarted the company’s downfall. However, Carreyrou acknowledges his investigation would not have occurred if it were not for pathologist Clapper.
“Without Adam Clapper, I am almost 100% sure that I wouldn’t have done anything,” Carreyrou told the Missourian. “It was the combination of him calling me and telling me what he had found out and how he felt and my feelings about the New Yorker story that really got me on the call of this scandal,” he said.
Anatomic and clinical pathologist Adam Clapper, MD (above), became skeptical about Holmes’ claims after reading a profile on her in The New Yorker. In December 2014, Clapper ended a post on his now defunct Pathology Blawg by saying, “Until proven otherwise, I’m going to be skeptical of Theranos’ claims.” That comment became a starting point for Carreyrou’s later investigation into Theranos. (Photo copyright: Missourian.)
According to the Missourian, Clapper turned to
Carreyrou because the reporter had impressed him as “very fact-oriented and
fact-driven” during telephone interviews for a series Carreyrou had written the
year prior on Medicare fraud.
“I could hear his wheels spinning in his head as we were
talking the first time, then he definitely sounded interested and intrigued,”
Clapper told the Missourian. “And then I could tell he was even more so
because very soon thereafter—like half an hour after that initial
conversation—he’d already started to do some research into Theranos.”
Ten months later, the WSJ published Carreyrou’s first
installment of his series on Theranos.
“The fact that this tip originated from a guy in Columbia,
Missouri, thousands of miles from Silicon Valley—who never spoke to Elizabeth
Holmes, who had no connection to the company or even to Silicon Valley other
than he read about her claims in a magazine and knew a lot about this by virtue
of being a pathologist—tells you that the people who put in all the money in [Theranos]
didn’t spend enough time talking to experts and asking them what was feasible
and what wasn’t,” said Carreyrou.
Benjamin Mazer, MD (above), an anatomic and clinical pathology resident in pathology and lab medicine at Yale New Haven Hospital, argues pathologists’ voices were noticeably—and critically—absent from media coverage during Theranos’ decade-long ascension. “For many of us in the pathology community, the writing was on the wall long before Carreyrou’s article was published,” he wrote in Health News Review. “Had journalists consulted pathologists as expert sources, the news coverage of Theranos might have been less fawning and more skeptical. Patients might have been spared erroneous tests.” (Photo copyright: Yale University.)
The lawyers defending Holmes against criminal fraud charges are contending Carreyrou “went beyond reporting the Theranos story” by prodding sources to contact federal regulators about the company’s alleged frauds and “possibly biased the agencies’ findings against [Theranos],” Bloomberg News reported.
Carreyrou told New York Magazine he doesn’t blame reporters for hyping Holmes and the technology she touted.
“You could make a case that maybe they should have done more
reporting beyond interviewing her and her immediate entourage,” he said. “But
how much is a writer/reporter to blame when the subject is bald-face lying to
him, too?”
Nonetheless, the Theranos scandal offers a lesson to
pathologists and clinical laboratory professionals in the importance of
building good working relationships with healthcare journalists who not only
must accurately report on healthcare breakthroughs and developments, but also
need someone they can trust for an unbiased opinion.
