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Clinical Laboratories and Pathology Groups

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Clinical Laboratories and Pathology Groups

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Mitchell Cancer Institute in Alabama Combines New Robotic Method for Detecting and Excising Biopsies with Rapid On-site Evaluation (ROSE) to Speed Diagnosis of Lung Cancer

Mitchell Cancer Institute in Alabama Combines New Robotic Method for Detecting and Excising Biopsies with Rapid On-site Evaluation (ROSE) to Speed Diagnosis of Lung Cancer

Combining robotic-assisted bronchoscopy with rapid on-site evaluation by cytopathologists enables cancer evaluation and diagnosis in one procedure

New technologies are making it possible to both collect a tissue biopsy and diagnose lung cancer during the same procedure. Cytopathologist are essential in this unique approach, which has the potential to greatly shorten the time required to diagnose lung cancer.

At USA Health Mitchell Cancer Institute in Alabama, a team consisting of pulmonology, pathology, surgical, and medical oncology specialists can diagnose lung cancer significantly faster thanks to the combining of a robotic-assisted bronchoscopy (RAB) system with rapid on-site evaluation of biopsies (ROSE) by a cytopathologist during the same procedure.

The RAB platform was created by Auris Health in Redwood City, Calif. According to a USA Health new release, the Auris Health Monarch “enables physicians to see inside the lung and biopsy hard-to-reach nodules using a flexible endoscope. When combined with rapid on-site evaluation (ROSE) it allows for diagnosis at the time of bronchoscopy.”

USA Health says it is the only academic health system in Alabama to combine the Auris Health Monarch (Monarch) with ROSE to diagnose lung cancer in a single procedure. 

“Nine-nine percent of the time we make a diagnosis—negative or positive (at time of bronchoscopy). We don’t have to do repeat procedures,” said Elba Turbat-Herrera, MD, Director of Pathological Services at USA Health’s Mitchell Cancer Institute (MCI) and Professor, MCI Interdisciplinary Clinical Oncology, in an exclusive interview with Dark Daily.

The American Society for Cytopathology defines ROSE as “a clinical service provided for patients where a pathologist, or in certain settings, an experienced and appropriately qualified cytotechnologist provides immediate real‐time evaluation of a fine needle aspiration (FNA) biopsy or touch imprints of a core biopsy.”

As a cytopathologist, Turbat-Herrera performs ROSE during procedures at USA Health. “I think we have improved diagnostics very much. With the Monarch equipment, one can see where the needle is traveling in the bronchial tube. It is more precise,” Turbat-Herrera explained.

Patients Benefit from Robotic-assisted Bronchoscopy

Traditionally, anatomic pathologists receive core (tissue sampling) biopsies and fine-needle aspiration biopsies from doctors looking to determine if a lung nodule may be cancerous. But the procedures to secure the biopsies are invasive and stressful for patients waiting for results from clinical laboratories. And some nodules are difficult for surgeons to reach, which can delay care to patients.

Brian Persing, MD

“The Monarch and ROSE technologies represent a huge step forward in lung bronchoscopy. Being able to see directly inside the lung and evaluate samples immediately provides the most advanced care for patients,” said Brian Persing, MD (above), Medical Oncologist, Mitchell Cancer Institute, and Assistant Professor of Interdisciplinary Clinical Oncology at the University of South Alabama College of Medicine, in the news release. (Photo copyright: University of South Alabama.)

Currently, more than 112 US healthcare providers use the Monarch robotic-assisted bronchoscopy (RAB) platform, which garnered US Food and Drug Administration (FDA) clearance in 2018, the USA Health news release noted.

The Monarch platform, according to USA Health, “integrates robotics, micro-instrumentation, endoscope design, and data science into one platform to empower physicians.”

Monarch's "controller-like interface"

Monarch’s “controller-like interface” (seen above) enables physicians to operate the endoscope and access small and “hard-to-reach” lung nodules. “The Monarch platform,” Duluth News Tribune explained, “is an endoscope guided by a handheld controller very similar to an Xbox controller. As the Monarch Platform drives through the lungs, the camera and other diagrams on a screen help the physician locate the nodule, then collect the biopsy with better accuracy and precision.” (Photo copyright: Jed Carlson/Superior Telegram/Duluth News Tribune.)

Eric Swanson, a pulmonologist at Essentia Health-St. Mary’s Medical Center in Duluth, MD, calls Monarch a game changer. “It’s a big, big upgrade from what we had before,” Swanson told the Duluth News Tribune. “(Before), you’d just pass a small catheter through a regular bronchoscope, and you turn it and hope you land in the right spot.”

The Monarch platform has enabled USA Health to step-up diagnosis of lung cancer, as compared to FNA (fine needle aspiration) biopsy on its own, according to Turbat-Herrera.

“With FNA alone, you try to get (sample tissue), and you are not sure. Now, if it is there, you should get it because the (Monarch) equipment helps you get there. Our role in pathology is to help guide the hand of the pulmonologist: ‘you don’t have what we need,’ or ‘keep going in that area of the lung,’” she said, adding that physicians have been able to reach tiny lesions.

High Incidence of Lung Cancer

The American Cancer Society, says lung cancer is the second most common cancer, with an estimated 235,760 new lung cancer cases and 131,880 deaths from the disease in 2021.

It’s hoped that healthcare providers’ investment in new robotic technology—such as Monarch and others—may shorten the time required to diagnose lung cancer and eventually save lives.

Providers such as USA Health go a step further by integrating ROSE with RAB. The robotic technology—coupled with on-site rapid evaluation by a cytopathologist that averts repeat biopsy procedures—immediately secures an assessment of sample adequacy and a cancer diagnosis that may benefit patients as well.  

This is yet another example of how a new technology in one field can have a benefit for anatomic pathologists.   

Donna Marie Pocius

Related Information:

USA Health Mitchell Cancer Institute Offers State-of-the-Art Lung Cancer Diagnosis

FDA Clears Auris Health’s Robotic Monarch Platform for Endoscopy

New Robotic Diagnostic Device Searches for Lung Cancer

High Diagnostic Yield in Sampling Sub-Centimeter Peripheral Pulmonary Nodules with Robotic-Assisted Bronchoscopy

ASC Rapid On‐Site Evaluation (ROSE) Position Statement

In the Field, Clinical Laboratory Specimen Transportation is Being Complicated by the COVID-19 Pandemic

Lab leaders who adopt best practices in courier services will help ensure their lab’s supply chains remain secure

Hospital and health systems using courier services to transport patients’ biological specimens from doctors’ offices and other locations to clinical laboratories for testing and reporting are finding those services delayed or disrupted by the COVID-19 pandemic.  

Limited office hours, closed physician practices, and the need for drivers to take time for symptom checking on healthcare campuses are among the growing challenges faced by couriers transporting medical laboratory specimens during this pandemic, experts told Dark Daily.

All these developments require courier operations and logistics companies to think outside the box for solutions that address the unique challenges triggered by the SARS-CoV-2 pandemic that have disrupted the normal operations of physicians’ offices, hospitals, and other healthcare providers. For example, many clinical labs struggle to obtain enough specimen collection and specimen transport supplies to sustain both their nascent COVID-19 testing programs and their routine testing operations.

One national logistics company recognized that it could help labs with the disruption in the supply chain for laboratory supplies caused by the coronavirus outbreak. In the early weeks of the pandemic, West Haven, Conn.-based Lab Logistics and its sister company Path-Tec, took the initiative to develop collaborations and strategic partnerships with several established manufacturers of medical laboratory supplies. Now it could not only be a source of much-needed supplies for its clients, but its network of couriers could supply the increase in services for all the locations where such supplies were needed.

Meanwhile, the coronavirus outbreak caused widespread disruption to the daily activities of hospitals, health systems, physician’s offices, and other providers. According to Susan Uihlein, Senior Vice President Business Development-Hospital Couriers at Lab Logistics—a company that creates, implements, and manages courier models customized to medical laboratory, hospitals, and health systems—in response to the pandemic, there was an immediate need by one of the largest multi-regional Health Systems in New York to align courier and logistics services to meet the new realities of how its facilities would respond to patient needs. It was also necessary that logistics solutions be complementary with the health systems’ COVID-19 policies.

“This health system requested that Lab Logistics’ drivers access the hospital’s personnel tracking application upon arrival,” explained Uihlein. “The health system’s new COVID-19 policy required everyone wishing to enter the health system campus to complete a coronavirus screening process—including having a temperature reading taken—and then receive a status confirmation on a smartphone screen. This obviously impacted the couriers’ progress on their routes.”

“We have 2,600 medical-specific couriers throughout the United States, and although all couriers undergo extensive orientation regarding known infectious transport, this current situation has spotlighted how important (COVID-19) is to our clients,” Brian McArdle, President and Chief Executive Officer of Lab Logistics, told Dark Daily.

“The couriers represent us and our clients,” he continued. “They are out in the field, they are picking up, delivering, and rolling with the punches as far as what a healthcare system or a clinical laboratory needs from them—from photo IDs to wearing masks and gloves. The process keeps evolving. And we have evolved with it.”

 “Our operations team makes sure that we work with each client to flexibly react to changes in that day’s pickups and deliveries, as appropriate. There has been much optimization and on-the-fly changes,” said Uihlein.

In fact, the coronavirus pandemic resulted in a 26% increase in requests for specimen delivery, PPE, and COVID-19 related supply chain movement, according to data on the California, Louisiana, and New York City healthcare markets provided by Lab Logistics.

“Every day there have been changes to what is open and closed. We had to manage that through our proprietary healthcare dispatch system and with the couriers,” Susan Uihlein (above), Senior Vice President Business Development-Hospital Couriers at Lab Logistics, told Dark Daily. Lab Logistics transports medical specimens, supplies, and pharma for more than 350 US hospitals, healthcare systems, and clinical laboratories. (Photo copyright: LinkedIn.)

Clinical Laboratories Should Review Specimen Transport Procedures

Clearly, the COVID-19 pandemic is putting unique stresses on the logistics and transportation services operated by hospital systems, medical labs and anatomic pathology groups. That why it would be timely and appropriate for lab leaders to review/update best practices and necessary requirements that ensure efficient management of clinical laboratory specimens.

“The COVID-19 pandemic triggered heightened risks in security, custody, and transit tracking of specimens so as to maintain a heightened biosafety level, while at the same time, the pandemic dramatically reduced the daily volume of more routine lab samples,” notes a Special Edition White Paper Dark Daily produced in partnership with Lab Logistics, titled, “Specimen Management and Logistics Issues to Evaluate for Continuous Quality Improvement—3 High-Risk Medical Courier Support Services.”

Topics covered in this highly-informative white paper include:

  • Handling and tracking laboratory specimen samples;
  • Confirming medical security, chain of custody, and transit tracking;
  • Coordinating test kits, supplies, reagents, lab equipment, and instruments;
  • Approaching a medical courier service conversion.

“By utilizing a logistics system that includes a dedicated courier, medical laboratories and healthcare systems can manage all aspects of transportation specimen transport, including handling and tracking of specimens, medical security, chain of custody, tracking supply inventory, and delivery. Successfully executed, all of these functions can generate financial improvements,” notes the white paper.

Tracking Specimen Arrival and Predicting Which Tests Will Be Needed

One technology that lab and healthcare system leaders can use to control costs and staffing involves online real-time tracking of drivers to enhance test turnaround time and determine when tests will be performed.

Lab Logistics’ version of this technology uses barcode scanning, GPS (Global Positioning System) tracking, and an online portal that enables its clients to view the routes and stops a driver has made for the lab. Lab leaders can determine how many specimens are expected, and what type of tests will be required, before the specimens arrive.

“They can see the volume coming in and they can staff-up based on the information we are giving them and not over-staff. It’s really good information,” Uihlein said.

Lab Logistics’ platform also integrates with a hospital’s laboratory information system (LIS) through the lab’s barcode. “The integration makes it possible for labs to get faster information from the field into their systems and create accessioning,” Uihlein explained.

Specimen Management Improved through Route Tracking

Tracking their drivers has enabled some labs to find new routes with less stops. Mike Napolitano, former General Manager for Constitution Diagnostics Network, Sunrise Medical Laboratory, and Sonic Healthcare, discovered that modified routes enhanced his lab’s efficiency. 

“We found that some drivers were doing daily pickups and we were not getting any specimens. Some clients were on vacation, stopped using the laboratory altogether, or weren’t doing that type of laboratory work anymore,” Napolitano told the white paper researchers.

Driver tracking also enabled Ochsner Health System in Louisiana to avoid “hot shots”—one-time delivery pickups which could be 90 miles away from the lab, explained Lloyd Gravois, Assistant Vice President of Logistics-Supply Chain, in the white paper. 

Medical laboratory leaders who wish to enhance their lab’s specimen management and solve logistics issues during and after the COVID-19 pandemic are encouraged to download a copy of the Free Special Edition white paper by clicking here, or by placing this URL in their web browsers:

—Donna Marie Pocius

Related Information:

Specimen Management and Logistics Issues to Evaluate for Continuous Quality Improvement: 3 High-Risk Medical Courier Support Services