New digital assessment helps lab leaders identify systemic safety gaps before serious injuries and fatalities occur.
Dark Daily’s sister publication, Lab Manager, recently reported that the National Safety Council (NSC) has launched a new digital assessment tool designed to help laboratories identify systemic safety weaknesses before they lead to serious injuries and fatalities—high-consequence events that can carry significant human and financial costs.
Called the Organization Safety Gap Analysis Tool, the platform adapts NSC’s evidence-based SIF Prevention Model into an interactive, structured evaluation tailored to complex work environments such as clinical laboratories. The initiative was developed through NSC’s Work to Zero program in partnership with the NCCCO Foundation.
For clinical laboratories that already operate on tight staffing models, the NSC tool may help identify areas for investment that will keep workers safer.
Moving Beyond Compliance to Prevent High-Severity Laboratory Incidents
Serious injuries and fatalities (SIFs) are rare but catastrophic events that result in life-altering harm or death. In laboratory settings, they can arise from chemical exposures, fires, equipment malfunctions, uncontrolled energy releases, or containment failures. Unlike minor injuries, SIFs typically emerge from organizational and system-level breakdowns rather than a single unsafe act—making them difficult to detect through conventional safety audits.
Traditional compliance reviews often focus on lagging indicators such as recordable injury rates and incident counts. While those metrics remain important, they do not necessarily reveal whether safety systems are strong enough to prevent high-severity events. The new SIF prevention tool shifts the emphasis from counting past incidents to evaluating whether leadership practices, hazard identification processes, and control systems are capable of preventing catastrophic outcomes.
The digital assessment can be completed in approximately 10 to 15 minutes. Laboratory leaders respond to a series of statements using a color-coded scoring system—green for full compliance, yellow for partial compliance, and red for limited or no evidence of compliance. The platform then generates a customized summary highlighting strengths, identifying safety gaps, and offering targeted recommendations aligned with best practices.
The tool evaluates performance across seven core elements that NSC identifies as critical to preventing serious injuries and fatalities: the safety and health operating environment; management leadership; worker engagement; hazard identification and prioritization; hazard abatement and control; implementation and operation; and continuous improvement.
High-Severity Risk is a Business Risk
Together, these elements are designed to uncover systemic vulnerabilities that may not surface during routine inspections or regulatory compliance reviews.
For laboratories, the business implications extend well beyond worker safety. Clinical labs routinely handle volatile chemicals, compressed gases, biological agents, cryogenic systems, and high-energy equipment. While most facilities meet baseline regulatory requirements, catastrophic incidents often occur when multiple small failures align—failures that may go unnoticed without a structured, system-level evaluation.
A single serious event can result in operational shutdowns, regulatory scrutiny, liability exposure, reputational damage, and increased insurance costs. As accrediting bodies and regulators place greater emphasis on high-severity risk prevention, laboratory leaders are under increasing pressure to demonstrate that their safety programs are proactive, data-driven, and capable of controlling enterprise-level risk.
By benchmarking safety maturity and pinpointing gaps in leadership alignment, hazard prioritization, and control effectiveness, the SIF prevention tool offers laboratory managers a framework for more strategic decision-making. Results can inform investments in engineering controls, workforce training, operational safeguards, and internal audit processes.
As laboratory environments grow more complex and regulatory expectations continue to evolve, industry observers note that organizations can no longer rely solely on compliance-based approaches. Systematic prevention of high-consequence events is becoming a core component of sustainable laboratory operations—and a critical safeguard for both people and business continuity.
Until then, clinical laboratory professionals must push the proposed legislation forward to achieve PAMA reform.
Officials from one of the key groups behind the proposed RESULTS Act stated earlier this month that the goal is to have the legislation attached to a year-end spending bill in Congress.
That leaves approximately 10 months for the clinical laboratory industry to mount enough momentum to bring the proposal to a vote.
“It is never easy to get anything done on Capitol Hill,” noted Joyce Gresko, legal counsel for the American Clinical Laboratory Association (ACLA) and an attorney at Alston & Bird.
Gresko spoke during a Feb. 11 webinar hosted by ACLA about the current lab operating environment under the Protecting Access to Medicare Act of 2014 (PAMA). PAMA-related cuts to clinical lab test reimbursement rates have been delayed until Jan. 1, 2027. However, in the nearer term, an important reporting milestone under PAMA begins on May 1.
Joyce Gresko, legal counsel for the ACLA and an attorney at Alston & Bird, urged clinical laboratories to contact members of Congress about passing the RESULTS Act. (Photo credit: Alston & Bird)
The RESULTS Act—more formally the Reforming and Enhancing Sustainable Updates to Laboratory Testing Services Act of 2025—calls for PAMA reform by permanently capping reimbursement cuts to 5% annually and identifying an independent claims database to help the federal government set Medicare rates for lab test claims. Currently those rates are set through lab-based reporting, an approach that has been largely criticized by the diagnostics industry.
Gresko noted that ACLA is eyeing the idea of the RESULTS Act becoming part of an end-of-year spending package in December, which could allow the proposal to pass as part of a larger vote. Such packages are typical in Congress.
Lawmakers Need to Hear about Support for the RESULTS Act
The ACLA has been among the loudest voices in the clinical laboratory industry supporting passage of the RESULTS Act. The bill was introduced in September 2025, as reported by Dark Daily.
Through a special ACLA website, StopLabCuts.org, 190,000 messages have been sent to Congress from lab industry professionals, Gresko said. She urged others to let their opinions be heard by lawmakers.
“Please weigh in with your members of Congress,” she said.
PAMA cuts have costs the diagnostics industry $3.8 billion over the last decade, noted Susan Van Meter, president of the ACLA.
For labs, those cuts “have had a negative impact on being able to maintain access to a whole level of [diagnostic] services,” Van Meter added.
New PAMA Reporting Window Starts on May 1 for Clinical Labs
While the RESULTS Act gets debated, clinical laboratories will need to prepare for their next reporting window under PAMA, which begins on May 1 and ends on July 31.
PAMA requires affected labs to submit information about tests they perform to the Centers for Medicare and Medicaid Services, including what private payers reimbursed labs for each test. This data establishes Medicare reimbursement rates under the Clinical Laboratory Fee Schedule.
In a twist, Congress revised that data collection to include 2025 commercial rates for labs, not 2019 data as was originally mandated.
Laboratories that have not started preparing for this reporting window need to begin now.
A feasibility study shows disinfected lab plastics can be converted into reusable manufacturing raw material for new healthcare products.
Becton, Dickinson and Company (BD) and Envetec Sustainable Technologies have completed a joint feasibility study evaluating whether polystyrene Petri dishes can be disinfected, processed, and recycled into new manufacturing raw material suitable for healthcare products.
The pilot focused on unused BD BBL prepared plated media as post-industrial material. In the study, plates and their contents were shredded, separated, chemically disinfected, and converted into clean polymer flakes using Envetec’s GENERATIONS technology. The flakes were then extruded into polystyrene pellets and molded into new Petri dish prototypes.
According to the companies, material property testing and molding feasibility were successfully completed.
The results suggest that polystyrene can be processed and reused in a manner that maintains properties required for manufacturing. The companies also reported that other common healthcare polymers—including polyester (PET), polypropylene, and polyethylene—may be suitable for similar treatment and reuse following disinfection and processing.
Envetec’s GENERATIONS technology uses what the company describes as a validated, low-energy chemical disinfection process to convert regulated medical waste into recyclable polymer flakes. The system is designed to process biohazardous and other regulated waste streams and render them suitable for downstream recycling applications.
Waste Volume and PFAS Scrutiny Add Complexity to Lab Plastics Recycling Efforts
For clinical and laboratory professionals, the pilot addresses a persistent operational issue: the large volume of single-use plastic consumables generated in microbiology, molecular diagnostics, and other laboratory settings. Petri dishes, blood collection tubes, pipette tips, and other items are typically disposed of as regulated waste due to contamination risk. Recycling options have historically been limited because of infection control requirements and material degradation concerns.
Per- and polyfluoroalkyl substances (PFAS) are an emerging concern across the healthcare and laboratory supply chain because of their persistence in the environment and potential health risks. PFAS have historically been used in a range of industrial and manufacturing applications due to their resistance to heat, water, and chemicals, and scrutiny has increased as regulators assess their presence in plastics, coatings, packaging, and manufacturing processes. In the clinical laboratory sector, attention is focused on whether PFAS are used in raw materials, production aids, or surface treatments for consumables and instruments, as well as how disposal or recycling pathways might affect environmental release. For laboratories, PFAS considerations may intersect with procurement policies, environmental health and safety programs, and vendor due diligence, particularly as sustainability and chemical transparency become more prominent in contracting and accreditation discussions.
Nikos Pavlidis, worldwide president of diagnostic solutions at BD, said, “Single-use devices made of high-quality plastics play a critical role in modern health care due to safety, ease of use and scalability, but we recognize the long-term impact that these materials can have on the environment.” (Photo credit: BD)
He added that the pilot “represents an important step toward enabling circular economy solutions for other high-volume healthcare consumables made from commonly used plastics, such as blood collection tubes, syringes and packaging.”
The study was conducted by BD’s Sustainable Medical Technologies Institute. The companies indicated they see opportunities to expand the pilot and further evaluate circular processing models for other plastic consumables used in healthcare and laboratory environments.
Envetec reports that its GENERATIONS technology is currently deployed in biopharma and life sciences facilities, hospitals, and food and beverage operations in the United States and Europe. The company is working with customers and recycling partners to develop pathways that convert treated laboratory plastics into recycled pellets and, where feasible, new plastic products.
For laboratories, broader adoption would likely depend on regulatory acceptance, validation of sterility and material performance, and integration with existing waste management workflows.
This article was created with the assistance of generative AI and has undergone editorial review before publishing.
The association urges stronger regulations and data standards to keep AI safe and fair in clinical laboratories.
The Association for Diagnostics & Laboratory Medicine (ADLM) is calling on Congress and federal regulators to modernize laboratory oversight as artificial intelligence (AI) becomes more embedded in clinical testing, warning that without updated safeguards, AI tools could put patients—particularly those from historically marginalized groups—at risk.
In a recently released position statement, ADLM cautions that while AI has the potential to improve diagnostic accuracy, streamline laboratory workflows, and strengthen data-driven decision-making, poorly governed systems could amplify bias and undermine patient safety. For laboratory professionals evaluating or deploying AI-enabled tools, the message is clear: Oversight, validation, and data integrity must keep pace with innovation.
Bias Risks Drive Push to Update CLIA and Standardize AI Oversight in Clinical Labs
AI models are only as reliable as the data used to train them, the organization noted. When systems are built on limited, inconsistent, or historically skewed datasets, they may replicate societal inequities. In healthcare, that can translate into underestimating disease risk or misclassifying conditions in racial and ethnic minorities, older adults, and underserved populations. Because many AI health tools rely on historical datasets that underrepresent certain groups, laboratories could unknowingly implement algorithms that perform unevenly across patient demographics.
To address those risks, ADLM is urging federal policymakers to explicitly incorporate AI systems into existing laboratory regulations, including updates to the Clinical Laboratory Improvement Amendments (CLIA). The group also recommends that federal health agencies work with professional societies to convene laboratory medicine and informatics experts to establish consensus guidelines for validating and verifying AI tools used in test interpretation and clinical decision support.
As reported on in 2025 by The Dark Report, the call comes in the wake of the federal government’s decision last year to eliminate the Clinical Laboratory Improvement Advisory Committee (CLIAC), a key advisory body to CMS and CDC that could have served as a natural forum for advancing ADLM’s proposed updates to CLIA to address artificial intelligence oversight.
Clinical Labs Push for Data Standards and Clear AI Accountability
In addition, ADLM is calling for expanded federal efforts to harmonize laboratory test results and standardize data reporting. Foundational steps, the organization argues, for reducing variability that can compromise algorithm performance. The statement also presses AI developers to increase data diversity, minimize bias in training datasets, and ensure laboratories have access to the technical information needed to independently evaluate algorithm performance.
“Clinical laboratories are uniquely positioned to help develop and assess the integration of AI health tools into testing workflows and, most importantly, how they influence patient test results and health outcomes,” said ADLM President Paul J. Jannetto, PhD.
Jannetto added, “We therefore urge the federal government to draw on the expertise of laboratory medicine professionals in order to develop AI regulations that support innovation, as well as transparent, consistent performance monitoring of this potentially revolutionary technology.” (Photo credit: ADLM)
For lab executives and medical directors, the position statement reinforces a growing reality: AI governance is quickly becoming a core operational and compliance issue. As adoption accelerates, laboratories may face heightened expectations from regulators, payers, and health system partners to demonstrate that AI-driven tools are analytically sound, clinically validated, and equitable across patient populations.
Genetic tests make up just 5% of volume but now drive 43% of Medicare Part B lab spending, according to OIG’s latest report.
Medicare Part B spending on clinical laboratory testing rose to $8.4 billion in 2024, a 5% increase over the previous year, according to the Department of Health and Human Services’ Office of Inspector General (OIG). For laboratory professionals, the headline is not just rising spending—it’s where the money is flowing.
Although genetic tests accounted for only 5% of all Part B tests performed in 2024, they represented 43% of total lab spending—$3.6 billion. In contrast, the far larger volume of routine chemistry, hematology, and other non-genetic tests generated $4.8 billion. Spending on non-genetic testing has generally declined since 2021, while genetic testing expenditures climbed 20% between 2023 and 2024 alone.
Utilization trends help explain the shift. The number of genetic tests paid under Part B increased 160% between 2018 and 2024, reaching 18 million tests last year. Meanwhile, non-genetic testing volume declined 12% over the same period. More enrollees are receiving at least one genetic test per year, and per-enrollee payments for those services are rising sharply.
Genetic Testing Drives Revenue Growth
In 2024, Medicare paid an average of $794 per enrollee for genetic testing—a 26% jump from 2023. By comparison, per-enrollee spending for non-genetic testing remained relatively stable at just over $200 annually. Even as overall Part B enrollment receiving clinical lab services declined 15% since 2018, spending per genetic-testing patient increased, amplifying the financial impact of molecular diagnostics on lab revenue.
OIG suggests the decline in Part B enrollees receiving lab tests may reflect migration to Medicare Advantage plans. For independent labs heavily dependent on traditional fee-for-service Part B volume, this shift adds another layer of financial pressure and underscores the need to monitor payer mix closely.
Attorney Alissa D. Fleming, a shareholder at Baker, Donelson, Bearman, Caldwell & Berkowitz, PC, told The Dark Report that federal audit risks have increased because of the OIG’s genetic test findings. The Dark Report is a sibling brand to Dark Daily.
High-Dollar Molecular Codes Dominate the Top 25
The concentration of revenue in high-priced molecular assays is intensifying. In 2024, 346 laboratories received more than $1 million in Medicare payments for genetic tests; 55 labs exceeded $10 million. The top 25 laboratory procedure codes accounted for nearly half of all Part B lab spending—more than $4.1 billion.
Genetic tests dominated the fastest-growing segments. CPT code 87798—used for infectious agent detection by nucleic acid when no organism-specific code exists—generated $443 million in 2024, a 51% increase over 2023, making it the highest-paid lab test under Part B. An epilepsy genomic panel (CPT 81419) posted a fivefold spending increase year over year. Several oncology liquid biopsy assays remain among the highest-reimbursed tests, with median payments reaching into the thousands of dollars.
Routine Testing Holds Volume—but Not Spending Power
In contrast, routine tests familiar to every clinical laboratory—comprehensive metabolic panels (80053), CBCs (85025), lipid panels (80061), thyroid testing (84443), and A1C (83036)—either declined or remained flat in spending. Comprehensive metabolic panel spending has dropped 25% since 2018 and fell from the top spending position in 2023 to second place in 2024. These high-volume, low-margin tests continue to anchor daily lab operations but represent a shrinking share of total Medicare dollars.
Importantly, OIG notes that these shifts are not driven by changes in the Clinical Laboratory Fee Schedule, which has remained largely frozen since 2020 under provisions from the Protecting Access to Medicare Act. Instead, spending growth reflects changes in utilization, test mix, and per-enrollee costs.
For clinical laboratory leaders, the message is clear: Medicare’s lab dollars are increasingly concentrated in molecular diagnostics. That shift brings opportunity—but also heightened regulatory scrutiny. OIG’s history of fraud alerts and audits in genetic testing suggests that compliance, documentation, and medical necessity controls will remain critical as high-complexity testing continues to expand within the Medicare population.
This article was created with the assistance of generative AI and has undergone editorial review before publishing.
Promising retrospective results raise long-term possibilities for labs, even as clinical and regulatory plans remain unclear.
NIH-supported researchers have identified a new four-marker blood test that may improve the early detection of pancreatic ductal adenocarcinoma (PDAC), one of the deadliest and most difficult cancers to diagnose at a treatable stage. The findings, published in Clinical Cancer Research, could have long-term implications for clinical laboratories if the approach is validated in future studies, though significant hurdles remain before it could reach routine clinical use.
Pancreatic cancer has a notoriously poor prognosis, largely because it is often diagnosed after the disease has already advanced. According to the researchers, “only about 1 in 10 pancreatic cancer patients survive more than five years from diagnosis.” By contrast, survival improves substantially when tumors are detected early. However, as the authors note, “there are no current screening methods” capable of reliably identifying pancreatic cancer before symptoms appear.
Why Existing Markers Fall Short
In the study, investigators from the University of Pennsylvania’s Perelman School of Medicine and the Mayo Clinic used a phased, retrospective approach to evaluate blood-based biomarkers using banked samples. Two previously studied markers—carbohydrate antigen 19-9 (CA19-9) and thrombospondin 2 (THBS2)—were included because of their historical relevance in pancreatic cancer research. CA19-9, for example, is commonly used in clinical settings to monitor treatment response.
However, neither marker has proven suitable for population screening. CA19-9 “can be elevated in people with benign conditions such as pancreatitis and bile duct obstruction,” and some individuals “don’t produce it at all due to genetic factors,” limiting its clinical specificity and sensitivity. These limitations are well known to laboratory professionals who routinely interpret CA19-9 results in oncology workflows.
The researchers identified two additional proteins—aminopeptidase N (ANPEP) and polymeric immunoglobulin receptor (PIGR)—that were elevated in early-stage pancreatic cancer patients compared with healthy controls. When combined with CA19-9 and THBS2, the resulting four-marker panel demonstrated improved performance.
For all cancer stages combined, the panel distinguished pancreatic cancer cases from non-cases 91.9% of the time at a false positive rate of 5%. For early-stage disease (stage I and II), the test identified 87.5% of cases.
“By adding ANPEP and PIGR to the existing markers, we’ve significantly improved our ability to detect this cancer when it’s most treatable,” said lead investigator Kenneth Zaret, PhD. (Photo credit: Perelman School of Medicine at the University of Pennsylvania)
Encouraging Performance, Early Days
Importantly for clinical laboratories, the test was able to differentiate cancer patients not only from healthy individuals, but also from patients with non-malignant pancreatic conditions, including pancreatitis—an area where many candidate biomarkers have historically struggled.
Despite the promising results, the authors stress that the findings are preliminary. “Our retrospective study findings warrant further testing in larger populations, particularly in people before they show symptoms,” Zaret said. He added that so-called “prediagnostic” studies would be required to determine whether the assay could be used as a screening tool in high-risk populations, such as individuals with a family history of pancreatic cancer or known genetic risk factors.
Notably, neither the NIH announcement nor the published coverage includes any public information about plans for FDA submission, commercialization, or clinical deployment of the test. There is no mention of whether the assay would be developed as a laboratory developed test (LDT), licensed to a diagnostics company, or pursued through a formal regulatory pathway.
For now, the four-marker panel represents a research advance rather than a near-term clinical offering. Still, it highlights how multi-analyte blood tests may eventually reshape cancer screening—and presents an area for clinical laboratories to watch closely as validation studies progress.
