How one PCR laboratory optimized workflows, reduced costs, and pivoted operations for improving profitability post-COVID
As variants of SARS-CoV-2 continue to confront physicians, PCR (polymerase chain reaction) instruments purchased for COVID-19 testing may still stand idle more often than not at reference and hospital laboratories. To make matters worse, clinical laboratory administrators must still deal with fluctuating demand for COVID testing, improving the profitability of COVID testing, and maximizing their investment in PCR instruments.
Despite the challenges, Birmingham, Alabama-based Streamline Scientific, formerly Assurance Scientific Laboratories, rallied last year to improve profitability of their now limited COVID testing and, at the same time, expanded lab operations instead of cutting back.
Laboratory Creativity Led to Value-Added Process Improvements for COVID-19 PCR Testing
In a recent interview with Dark Daily, Streamline Scientific’s Chief Scientific Officer Greer Massey, PhD, explained how the lab discovered ways to adjust operations to improve profitability after the drop in COVID-19 testing demand. They started with the testing process.
Optimizing workflows has been instrumental in the profitability of continued COVID PCR testing, according to Greer Massey, PhD (pictured), of Birmingham, Alabama-based Streamline Scientific, a reference lab that pivoted during the COVID-19 pandemic to make value-added process improvements and expand testing. (Photo copyright: Streamline Scientific.)
“Some COVID testing processes are labor intensive,” Massey said. “They require an initial step to extract and purify RNA from the collected specimen. Once the genetic material is separated from the specimen, it can then be amplified to look for the presence of the virus. The extraction process requires additional materials, time, and advanced training of medical technologists conducting the work.”
The Streamline team sought to simplify the COVID testing process and, ultimately, adopted an extractionless PCR method that improved efficiency in three ways:
Shorter turnaround times with faster delivery of test results;
A reduction in staff time needed for the extractionless COVID testing workflow; and
Optimized use of consumables, such as buffers, magnetic beads, plastics, and other supplies required for COVID and other testing.
The process improvements have reduced the cost per test by as much as 25%, reducing supply chain issues and improving overall profitability in the now struggling COVID test category.
In addition, Massey said, the benefits of the extractionless PCR process have inspired the lab to further optimize its reagent use. Working with its local supplier and their research and development unit, Molecular Designs, the reference lab now keeps an inventory of preplated PCR assays in sealed and barcode-labeled 384-well plates, as well as 96-well plates developed with a “breakaway” feature to accommodate variable testing volumes and support custom test panels. Plates are customizable from one to 94 targets, Massey said.
The unique breakaway feature of sealed, preplated PCR assays optimizes and customizes test runs not only for COVID-19 but for other infectious disease assays. (Photo copyright: Molecular Designs.)
“Being able to optimize workflows with items like extractionless and breakaway plates was instrumental in our profitability during COVID peaks and valleys, and it was also instrumental in managing expected TAT,” Massey added. “It also allowed us to release other panels such as COVID/Flu/RSV and larger respiratory panels when the importance of COVID-only diagnosis shifted to other important respiratory infections.”
Operationalizing a COVID-Pivot Experience: Consulting and Reagent Supply
Building on its success, Streamline Scientific now provides end-to-end consulting services for reference and hospital laboratories, as well as physician offices that manage in-house PCR testing.
“Streamline Scientific consults with reference, hospital, and physician office labs throughout the nation to share best practices and help identify the equipment, assays, or processes that improve workflow and profitability,” said Todd Speranzo, the company’s vice president of marketing.
“What we have learned from our customers is how important it is to understand reagent pricing and how that translates into operational profitability,” Speranza said. “We’re also looking for ways to deliver cost-effective infectious disease PCR assays that laboratories can use to expand their testing services while maintaining profitability. Molecular Designs’ preplated Simplicity Panels provide convenience, reducing the complexity, time, and costs associated.”
Molecular Designs is a team of doctors and scientists working to advance molecular diagnostics, Speranzo pointed out. “Their founding physicians entered the molecular diagnostics market focused on the most common pathogens that impact the population—making products that are cost-effective, reduce waste, and are easy-to-use.” The supplier has grown to offer numerous panels, including combination COVID 19-Flu-RSV and respiratory panels, UTI panels, wound/derm panels, sexually transmitted infection panels, gastrointestinal panels, fungal panels, and vaginitis panels; eight antimicrobial resistance classes are available as panel add-ons; and multiple other panels are in development.
Laboratory Outlook: Full Utilization of PCR Capacity and Ability to Respond to Changing Testing Needs
While the implementation of COVID-19 PCR testing has had a positive impact on patient care—and led to growth for reference laboratories and hospital labs—those who invested in PCR molecular testing equipment may face challenges with capacity and meeting changing needs.
Speranzo offers these tips for lab leaders sourcing PCR instruments.
Compare costs; prices have reduced from COVID peak.
Look beyond COGS for improved profitability; consider preplated options, extractionless, and breakaway plates, amongst other opportunities to improve efficiency and reduce waste.
Plan for the future; seek a partner with a robust research and development division that considers reimbursement and demand beyond COVID.
As lab leaders have experienced firsthand, nimble and adaptable operations were a critical success factor during the COVID pandemic. With the post-COVID pivot at hand, regional reference and hospital laboratory leaders will benefit from not only scrutinizing their PCR testing menus and costs but deciding what new assays will support opportunities in the year ahead.
—Liz Carey
This article was produced in collaboration with Streamline Scientific, a national reference lab and consulting organization. All products are for research use only. For more information, visit www.streamlinesci.com.
“The SDPR will consolidate geographically fragmented EMR, PAS, and LIMS systems to create a detailed lifelong patient record and deliver cost savings,” NSW Health said in a news release.
NSW Health is the largest public health system in Australia with more than 220 public hospitals, 16 Local Health Districts, and three Specialty Networks. NSW Health Pathology operates more than 60 pathology laboratories (clinical laboratories in the US) and has 150 patient service centers.
“While this initiative will provide untold benefits to all the patients of NSW, we are excited about its potential for improving the health outcomes of our regional patients,” said Andrew Montague (above), former Chief Executive, Central Coast Local Health District in a press release. “By enabling greater collaboration across all local health districts and specialty health networks, the Single Digital Patient Record will provide clinicians with even better tools to keep the patient at the center of everything we do.” This project is more market evidence of the trend to bring clinical laboratory test results from multiple lab sites into a single data repository. (Photo copyright: Coast Community News.)
Cloud-based Realtime Access to Patient Records
Australia has a population of about 26 million and New South Wales, a state on the east coast, is home to more than eight million people. Though the scale of healthcare in Australia is much smaller than in the US, this is still a major project to pull patient data together from all the NSW hospitals, physicians’ offices, and other healthcare providers such as clinical laboratories and pathology practices.
With the change, NSW clinicians will benefit from a cloud–based system offering up real-time access to patients’ medical records, NSW Health Pathology Chief Executive Tracey McCosker told ITnews.
“Patients and our busy staff will benefit from clinical insights gained from the capture of important new data. Our work in pathology is vital to the diagnostic process and developing a statewide laboratory information management system will ensure we provide the best possible services,” McCosker told ITnews.
The KLAS Research report, “US Hospital Market Share 2022,” states that Epic, located in Verona, Wisconsin, has the largest US electronic health record (EHR) market share, Healthgrades noted. According to KLAS:
NSW Health’s decision to engage Epic came after a process involving 350 clinicians, scientists, and technical experts, Zoran Bolevich, MD, Chief Executive of eHealth NSW and NSW Health’s Chief Information Officer, told ITnews.
NSW Health’s Goal for Statewide Digital Patient Record
It was in December 2020 when NSW Health announced its plan to create the SDPR.
“Our vision is to be able to provide a single, holistic, statewide view of every patient—and for that information to be readily accessible to anyone involved in the patient’s care,” Bolevich said in the news release.
The SDPR, according to NSW Health, will address the following:
Challenges:
Current systems not connected statewide.
Inaccessible patient data.
Duplicative data collection.
Gaps in decision-making.
Goals:
Improve health outcomes.
Create patient centricity.
Leverage insights.
NSW’s government has already invested more than $106 million in the SDPR, Healthcare IT News reported.
Other Large EHR Rollouts
NSW Health is not the only large organization to take on such an ambitious project of creating a large-scale digital patient record. And not always to a successful conclusion.
The US Department of Veterans Affairs (VA)—also intent on EHR modernization—recently announced it is suspending roll-out of the Oracle Cerner EHR at VA centers until June 2023 to address technical issues affecting appointments, referrals, and test results.
Four VA centers in Washington, Oregon, and Ohio already went live with the system in 2022.
“We are delaying all future deployments of the new EHR while we fully assess performance and address every concern. Veterans and clinicians deserve a seamless, modernized health record system, and we will not rest until they get it,” said Deputy Secretary of Veterans Affairs Donald Remy, JD, in a news release.
For its part, Oracle Cerner wrote federal lawmakers noting the importance of continuing the project, which will move the VA away from its former VistA health information system.
“Modernization requires change and some short-term pain for the long-term benefits of a modern technology infrastructure,” noted Oracle Cerner Executive Vice President Ken Glueck in the letter, Becker’s Health IT reported. “A modernization project of this scale and scope necessarily involves time to untangle the decades of customized processes established in support of VistA, which inevitably involves challenges.”
NSW Health’s goal is to build a single repository of health information—including lab test results from multiple clinical laboratory sites. When finished NSW Health expects that sharing patient data will contribute to producing better healthcare outcomes.
However, the VA’s experience—and several other similar attempts at large-scale electronic patient record installations—suggest the work ahead will not be easy. But for NSW Health, it may be worth the effort.
But insurers are complying under the Transparency in Coverage regulations and that is where discrepancies in the disclosure of prices to the public have been found
Despite federal regulations requiring hospitals to publicly post their prices in advance of patient services, some large health systems still do not follow the law. That’s according to a new Transparency in Coverage Report from PatientRightsAdvocate.org (PRA), which found that some hospitals are “flouting” the federal Hospital Price Transparency Rule.
By cross-referencing price disclosures by hospitals and insurance companies, which are required to publish the amounts they pay for hospital services under federal Transparency in Coverage regulations, PRA, a 501(c)(3) nonprofit, nonpartisan organization, discovered the healthcare providers’ noncompliance with federal transparency regulation.
“Prices revealed in newly released health insurance company data files show some major American hospitals are omitting prices from their required price disclosures in violation of the federal hospital price transparency rule,” according to the PRA report.
Hospitals conceal their prices because they don’t want people to know how much rates for the same procedure vary,” Sally C. Pipes (above), President and CEO of Pacific Research Institute, wrote in the Washington Examiner. “A lack of price transparency benefits hospitals but not patients or payers. The federal government should not let providers get away with flouting the law,” she added. Clinical laboratories are also required under federal law to publish their prices. (Photo copyright: The Heartland Institute.)
“PatientRightsAdvocate.org discovered several instances in which prices were omitted from the hospital files but appeared in the insurance company files,” noted the PRA report. “These discrepancies indicate that some large hospitals are not posting their complete price lists as required by the hospital price transparency rule.”
The federal Centers for Medicare and Medicaid Services (CMS) says hospitals must post standard charges in a single machine-readable digital file, and display in a consumer-friendly way, “300 shoppable services with discounted cash prices, payer-specific negotiated charges, and de-identified minimum and maximum negotiated charges.”
But according to the PRA report and news release, the study team discovered that this was not always the case. Below are examples from the report of some of the discrepancies between prices on a hospital’s website and what payers’ websites showed as prices involving those same hospitals:
PRA’s report casts light on inconsistencies between what insurers and providers share with the public on prices.
“Today’s report confirms that hospitals are hiding prices from patients and [this] calls into question their public assertions that individual prices don’t exist for many of the services they provide,” said PRA Founder and Chairman Cynthia Fisher in the news release.
“The data made possible by the [federal] Transparency in Coverage (TiC) rule reveals prices negotiated with insurers that hospitals did not disclose in the machine-readable files required by law. Our report is just the tip of the iceberg of what the staggering amount of data in TiC disclosures will reveal,” she added.
Ascension, HCA Note Compliance with CMS Rule
For its part, Ascension, in a statement to Healthcare Dive, confirmed it is complying with the CMS rule and offers consumers tools to estimate costs.
“We’re proud to be a leader in price transparency,” Ascension said.
HCA told Healthcare Dive it has “implemented federal transparency requirements in January 2021 and provides a patient payment estimator in addition to posting third-party contracted rates.”
Advice for Clinical Laboratories Sharing Test Prices
Hospitals flouting the federal transparency rule is not new. Dark Daily has covered other similar incidences.
Clinical laboratory leaders who oversee multiple labs in healthcare systems may benefit from advice about CMS rule compliance shared in HealthLeaders.
Post a separate file for each provider.
Be “cognizant” of different sets of standard charges for multiple hospitals under one license.
“Today’s healthcare consumer wants to know prices in advance of service. That’s because many have high deductible health insurance plans of, say, $5,000 for an individual or $10,000 for a family as the annual deductible,” said Robert Michel, Editor-in-Chief of Dark Daily and its sister publication The Dark Report.
Clinical laboratory tests may not be the most expensive healthcare service. But they are critical for high-quality hospital care and outcomes. Increasingly, patients want to know in advance how much they will cost. This is true of patients of all generations, from Baby Boomers to Generations X, Y, and Z.
Though burnout due to COVID-19 pandemic plays a role, the future is bright for pathology assistants
Anatomic pathology laboratories are expanding the role of Pathologist Assistants (PathAs) beyond the traditional duties. What does that mean for the future of this critical position? In an article she penned for the College of American Pathologists (CAP), certified pathologists’ assistant Heather Gaburo, MHS, PA(ASCP)cm, explains how PathA responsibilities are evolving to meet the needs of today’s surgical pathology suite and anatomic pathology service.
The PNPL in Woodbridge, Connecticut, funded the study and worked with various pathology laboratories to gather the information presented.
In her paper published in the Archives of Pathology and Laboratory Medicine, certified pathologists’ assistant Heather Gaburo (above), wrote “PathAs can fill a wide variety of nontraditional roles in hospital-based and private practice laboratory settings. In the current state of pathology, PathAs are underused in these roles.” (Photo copyright: American Association of Pathologists’ Assistants.)
Traditional Duties of PathAs
The job of the PathA was developed in the 1970s to fill a gap in the pathology workforce. Traditional duties for PathAs include, but are not limited to, tasks such as:
Macroscopic examination (grossing process) and dissection of surgical specimens,
Assisting with intraoperative frozen sections and autopsies.
However, this role is expanding. According Gaburo, the 2021 AAPA membership survey showed that PathAs duties have grown to include tasks such as:
Why have the duties of PathAs broadened so much? According to Gaburo, the COVID-19 pandemic had much to do with it.
COVID-19 Pandemic Leads to New Duties/Burnout for PathAs
“The pandemic increased public awareness of the clinical laboratory by highlighting essential clinical workers with frequent spotlights on COVID-19 testing and staffing shortages, as well as understaffing in the anatomic space,” Gaburo said in an exclusive interview with Dark Daily.
“COVID-19 caused delays in cancer screening and non-emergency surgery, which led to a backlog of cases and delayed cancer presentations. Some studies have shown an increase in late-stage cancer presentations, which can be more time-consuming to diagnose in pathology. Both factors are contributing to higher traditional workloads for PathAs,” she added.
The pandemic, according to Gaburo, also led to increased duties for PathAs. “The pandemic also provided PathAs with opportunities to assist in developing new protocols such as: handling surgical specimens from COVID-19 patients, enhanced safety procedures in the laboratory, and autopsies on SARS-CoV-2 patients.”
But, with this expansion of duties also comes with the threat of burnout. “I believe the pandemic contributed to the burnout of PathAs in several ways. Many labs faced staffing challenges as employees contracted COVID-19, straining the existing workforce,” she noted.
“Some personnel struggled to balance their jobs as essential workers with providing virtual schooling for their children. Workloads increased when surgical cases resumed to catch up with the patient backlog. The incoming specimens were more complex due to delays in screening and advanced disease at presentation,” Gaburo added.
Job retention is an issue also explored by Gaburo in her Archives of Pathology and Laboratory Medicine paper. “Almost half of the laboratory professionals (including PathAs) surveyed by the ASCP addressed being underappreciated, especially compared with nursing and other allied health professionals.” She goes on to cite the risks of worker burnout, including adverse errors that could lead to liability of healthcare organizations.
Gaburo notes that burnout was an issue for PathAs before the COVID-19 pandemic “possibly due to a lack of job diversity and opportunities for growth,” she said. But the COVID-19 pandemic provided a unique opportunity for many PathAs, as well.
“The pandemic, while it brought challenges, also provided opportunities for PathAs to step into new, temporary roles early on when surgeries were limited, and clinics were closed. This job diversification may have helped develop resiliency and decrease burnout.”
PathA Shortage and Educational Opportunities
The COVID-19 pandemic required the entire healthcare industry to be flexible and expand in a short time. This, according to Gaburo, contributed to the growth of PathAs’ duties and could have helped with job retention as well.
When asked whether there was a shortage of PathAs in clinical laboratories and anatomic pathology groups, Gaburo said, “Though there are many open jobs for PathAs, our profession is fortunate in that we are not experiencing the same type of shortage as other laboratory professions. Instead of struggling to fill vacant positions, it seems many of the PathA openings are newly created positions. In fact, the new graduate employment rate of most, if not all, PathA programs is 100%.”
However, pandemic-related stresses and burnout have led to a shortage of anatomic pathologists, Gaburo notes. But in this she also sees new opportunities for PathAs.
“This is an area where the utilization of pathologists’ assistants has value for pathologists. PathAs, with support and mentorship, can provide assistance in many areas at a lower cost than pathologists, freeing up the pathologists to devote more time to patient care activities.”
As Gaburo concludes in her paper, “PathAs are qualified allied health professionals capable of handling a wide range of nontraditional roles in the pathology laboratory.” She goes on to note how practices can choose to mentor and support their PathAs by offering them mentorship and diverse educational opportunities.
“Over the last 15 years, the number of training programs for PathAs has more than doubled, from seven to 15. Class sizes have also increased to meet the growing demand for admission, which has become more and more competitive.
“The curricula include basic laboratory management classes, and some programs are considering incorporating ‘Business of Pathology’ courses as well. Many programs have expanded their clinical rotation sites, leading to opportunities for experienced PathAs to move into nontraditional teaching roles by becoming preceptors. However, there is still a need for more high-level administrative training opportunities,” Gaburo wrote.
Job satisfaction and retention increases quality for everyone involved. As clinical laboratories and anatomic pathology groups continue to support COVID-19 testing on top of traditional laboratory requirements, pathologist assistants have proven—and will continue to prove—what a valuable asset they are to clinical pathology practices.
Clinical laboratories continue to test sample delivery by drone as a viable alternative to ground transport
In Switzerland, another clinical laboratory drone delivery service recently launched and it has several unique capabilities. This new pilot project to test the delivery of medical laboratory samples by UAV (unmanned aerial vehicle, aka drone) is being conducted by the Dr. Risch laboratory group and start-up drone company Jedsy.
What makes the Risch/Jedsy drone delivery service unique when compared to other drone delivery services is their drone’s capability to deliver directly to windows, regardless of where that window is. This, according to a Jedsy news release, “makes the transport of samples faster and more environmentally friendly.”
Dr. Risch group has 14 clinical laboratories and eight sample collection locations throughout Switzerland. The Swiss Federal Office of Civil Aviation (FOCA) approved Dr. Risch’s first flight between its lab in Vaduz, the capital of Liechtenstein, to its lab in Buchs St. Gallen, sUAS News reported. Risch began transporting lab samples between those locations on an experimental basis in December of 2022.
The Jedsy glider, as the drone is called, has a distinctive vertical takeoff, hover, and landing capability. Once it achieves a safe altitude, it transitions to forward flight and can travel at speeds up to 150 kilometers per hour or about 93 miles per hour.
All systems on the Jedsy drone are redundant and developed to be fail-safe. A human drone operator follows the flight visually via a livestream connection. Once the drone approaches a building for landing, with the exception of the docking station the entire surrounding area is blurred to ensure the privacy of nearby individuals.
The Jedsy Glider (above) is quieter than other multicopters, according to Jedsy, and is able to dock outside a window or balcony. This enables the convenient loading and unloading of clinical laboratory specimens in any type of weather. The docking station also serves as a charger for the drone’s battery to ensure the craft is available for use at any time. Similar medical laboratory sample drone delivery services have been tested in Switzerland but none with Dr. Risch Labs’ unique window delivery option. (Photo copyright: Jedsy.)
Why Transport Clinical Laboratory Samples by Drone?
“The last two years during the COVID-19 pandemic have shown convincingly how important this service is for the healthcare sector,” explained the medical laboratory group’s founder and CEO, Martin Risch, MD, in the Jedsy press release.
Risch envisions a need for drones in certain medical situations. Dr. Risch currently employs about 50 courier drivers who transport by ground medical samples to regional medical laboratories throughout Switzerland every day.
“If, however, the courier vehicles are stuck in traffic or if they are driving during rush hour, the planned daily routine regarding the analysis and the medical diagnosis is delayed. We hope that this will allow us to offer an even better service, which will ultimately benefit the patients,” Risch stated.
Jedsy has already utilized its glider drone successfully in Africa to deliver laboratory specimens and medicines to remote locations and looks forward to its continued benefits.
“With the new drone, we have already gained important flying experience in Malawi, where over 5,000 flights have been performed as part of the UNICEF drone corridor,” said aerospace engineer Herbert Weirather, founder and CEO of Jedsy, in the press release. “Health centers have already been supplied with critical medicines by Jedsy and the service is being expanded continuously,” he added.
Use of Drones to Deliver Clinical Laboratory Samples Growing Worldwide
Utilizing drones to deliver medical supplies and laboratory specimens is not a new concept and has been tested several times in the past. Dark Daily has previously reported on some of the projects that have been attempted.
The use of drones to deliver clinical laboratory specimens is a rising trend that could be extremely beneficial for healthcare systems, medical professionals, and patients. A number of clinical laboratories in the US and around the world have initiated drone pilot programs, however, there has been little follow-up press coverage about either the success of these efforts or whether they continue to operate.
Nevertheless, faster delivery of laboratory specimens can lead to more timely diagnoses which can potentially lead to better patient outcomes. In the future, it’s likely more clinical laboratories will receive specimens via drones.
Two former FDA commissioners who support changing oversight of laboratory-developed tests (LDTs) say FDA’s regulatory playbook is ‘outdated’
Congress’ attempts to avoid a government shutdown due to a lack of funding presents a final chance this year for two different clinical laboratory bills to be pushed through.
As Dark Daily’s sister publication The Dark Report, noted in “VALID and SALSA Acts Still Pending in Congress,” a standalone vote on either bill is unlikely this year. Instead, they would need to be attached to the larger spending bill. (If you’re not a subscriber to The Dark Report, check out our free trial.)
In an article for STAT, former FDA Commissioners Scott Gottlieb, MD (left), and Mark McClellan, MD, PhD (right), wrote, “The FDA is currently working from an outdated regulatory playbook that has left gaps in its oversight of safety and effectiveness and makes it more difficult to introduce new innovations. The [VALID Act] would strengthen protections for consumers and patients for both diagnostic tests and cosmetics and make it easier for manufacturers to introduce better products.” (Photo copyrights: FDA/American Well.)
Political Parties Negotiating
At press time, a draft spending bill had not yet been introduced to Congress as lawmakers from both political parties negotiate funding levels.
A source told The Dark Report that until legislators hammer out those details, add-ons such as the VALID Act or SALSA are stalled. There is no guarantee either lab measure will be added to the spending bill.
“We don’t have agreements to do virtually anything,” said Senate Minority Leader Mitch McConnell (R-KY) to reporters on Dec. 6, according to Reuters. “We don’t even have an overall agreement on how much we want to spend,” he added. Reuters reported that Democrats and Republicans in the Senate were $25 billion apart in their proposals.
Congress could also pass a continuing resolution to keep the government open for a short time, which would allow lawmakers more opportunity to negotiate.
Former FDA Chiefs Weigh In
Meanwhile, proponents of the VALID Act have publicly turned the heat up for the bill. For example, STAT recently ran two commentaries—including a joint piece from a pair of former FDA commissioners—in support of the VALID Act.
Currently, LDTs are regulated through the Clinical Laboratory Improvement Amendments of 1988 (CLIA). However, supporters of the VALID Act argue that the complexity of modern LDTs deserves more scrutiny.
“The VALID Act would create a consistent standard for all tests, regardless of the kind of facility they were developed in or made in, as well as a modern regulatory framework that’s uniquely designed for the recent and emerging technologies being used to develop tests,” wrote Scott Gottlieb, MD, and Mark McClellan, MD, PhD, in STAT on Dec. 5.
Gottlieb and McClellan served as FDA commissioners from 2017-2019 and 2002-2004 respectively. They both currently serve on various boards for biotech and healthcare companies.
Pathologists, Clinical Lab Directors Express Concerns about VALID Act
Opponents of the VALID Act contend that LDT innovation will be stifled if clinical laboratories, particularly those at academic medical centers, need to spend the time and money to go through formal FDA approval. There is evidence that working pathologists in academic settings have legitimate concerns about the negative consequences that might result if the VALID Act was passed as currently written.
In “Might Valid Act Support Be Waning in Congress?” The Dark Report covered how on June 1 more than 290 pathologists and clinical laboratory directors sent a grassroots letter to a Senate committee asking for a series of concessions to be made for academic medical center labs under the VALID Act.
It is reasonable to assert that the majority of clinical laboratory professionals and pathologists are supportive of the SALSA bill, which would stop the next round of scheduled price cuts—as much as a 15% price reduction to many tests—to the Medicare Part B Clinical Laboratory Fee Schedule (CLFS). That is not true of support for the VALID Act, as currently written. Sizeable segments of the diagnostics industry have taken opposing positions regarding passage of that legislation.
For these reasons, both bills will be closely watched in coming weeks as Congress works to fund the federal government while, at the same time, incorporating a variety of other bills under the omnibus bill, which is a considered a “must pass” by many senators and representatives.
