News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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Mount Sinai Health System Study Finds Use of AI-Enabled Monitoring System Improves Use of Blood During Childbirth

Study suggests AI-enabled technology can help clinical laboratories and hospital blood banks save thousands of dollars annually on expensive blood products

Artificial intelligence may prove to be a useful tool in helping hospitals better manage utilization of blood products. That’s one conclusion from a newly-published study done at New York’s Icahn School of Medicine at Mount Sinai. If so, this is a technology improvement that would be welcomed by blood bankers and clinical laboratory managers who must manage the cost and utilization of blood products.

There’s no way around it—blood is expensive. A typical 400- to 600-bed hospital likely budgets upwards of one million dollars annually just for blood products. Almost universally, in hospitals the medical laboratory manages the blood bank. This is where medical technologists trained in blood banking test patients and test blood to ensure whole blood units, or other blood products such as platelets, match and will not trigger a negative reaction when administered to the patient.

When left unmanaged, the cost and utilization of blood bank products can put the budgets of hospital medical laboratories in the red. Hospitals also invest a great deal of money training surgeons to accurately assess the procedure and order the correct amount of blood components prior to surgery.

Therefore, new artificial intelligence (AI) technology that helps pinpoint patients’ blood loss during childbirth will be of interest to blood bankers and hospital laboratory administrators.

Can AI Help Clinical Labs Improve Utilization of Blood Products in Hospitals?

Physicians at the Icahn School of Medicine at Mount Sinai recently investigated whether “Quantifying blood loss” would improve the use of blood during human childbirth. They published the results of their study in the International Journal of Obstetric Anesthesia.

Their research into 7,618 deliveries (vaginal and cesarean) involved “An observational study comparing blood loss, management, and outcomes between two historical cohorts (August 2016 to January 2017 and August 2017 to January 2018) at an academic tertiary care center. Patients in the intervention group (second period) had blood loss quantified compared with visual estimation for controls,” the research paper notes.

The researchers concluded that “Quantifying blood loss may result in increased vigilance for vaginal and cesarean delivery. We identified an association between quantifying blood loss and improved identification of postpartum hemorrhage, patient management steps, and cost savings.”

The researchers, according to a press release, employed the Triton AI-enabled platform from Gauss Surgical, a silicon valley-based health technology company, to “monitor blood loss in all deliveries (vaginal and cesarean, n=3807) at Mount Sinai Hospital from August 2017 through January 2018 to support the institution’s stage-based hemorrhage protocol.”

The researchers found that use of a monitoring system was associated with earlier postpartum hemorrhage intervention and annual cost savings of $172,614 in lab costs and $36,614 in blood bank costs.

Daniel Katz, MD (above), Director of Obstetric Anesthesia Research and Associate Professor Anesthesiology, Perioperative and Pain Medicine, at Mount Sinai Hospital in New York, said in the news release, “This study demonstrates that efficiently obtaining accurate, real-time blood loss information is critical to the successful implementation of a stage-based hemorrhage protocol.” Katz was the study’s lead author. (Photo copyright: Mount Sinai Hospital.)

Measuring Blood Loss: The Eye versus AI

Gauss has secured Food and Drug Administration (FDA) clearance for Triton and more than 50 US hospitals are using it. Triton provides, in real-time, images of blood-saturated surgical sponges and canisters and uses computer vision and machine learning to pinpoint blood loss, reported MD+DI.

Traditionally, physicians visually estimate blood loss during procedures. When they are off in their estimates of postpartum hemorrhage, harmful postpartum health complications and deaths can occur, the Mount Sinai researchers explained in their paper.

And although other vital signs—heart rate, rhythm, blood pressure, oxygen level, etc.— are monitored with equipment in the surgical suite, blood usage is not. 

“Blood loss in surgery has been an enigma for decades since the dawn of medicine,” Siddarth Satish, Founder and Chief Executive Officer of Gauss, told MD+DI. “We monitor many other vital signs in surgery, but ultimately there hasn’t been any direct indicator of a patient’s hemoglobin loss.”

Bleeding Better Recognized, Less Blood Transfusions

After the Mount Sinai researchers used the Triton system to monitor blood loss during 3,807 vaginal and cesarean deliveries from August 2017 to January 2018 at Mount Sinai Hospital, they compared their findings to 3,811 deliveries from August 2016 to January 2017, during which doctors relied solely on visual estimation of blood loss.

The study found the following, according to the news release:

  • Improved hemorrhage recognition in vaginal deliveries of 2.2% and cesarean sections of 12.6% compared to .5% and 6.4%, respectively;
  • Less blood transfusions needed (vaginal patients): 47% with Triton compared to 71%;
  • Reduced blood transfusion dose (cesarean section): 1.90 units with Triton compared to 2.52 units;
  • Cost savings: $209,228 a year (the total of aforementioned lab and blood bank costs).

“What we like about [Gauss] is that it somewhat embodies precision medicine in the sense that you’re using more precise tools of measurement in their first use case,” Garrett Vygantas, MD, MBA, Managing Director for OSF Ventures, the financing arm of OSF Healthcare, who also serves on Gauss Surgical’s board, told MD+DI.

Possible New Resource for Hospital Medical Laboratories

So, will AI quickly become an omnipresent overseer in surgical suites? Hardly. However, AI is in the early stages of finding places in healthcare where it can be useful.  “A lot of people are predicting that AI will play a huge role in healthcare … I think it’ll be ever-present. There will be a little bit of AI in everything you’re doing, but I think the actual practice of medicine in its truest form is going to carry forward,” Satish told Fierce Healthcare.

Hospital medical laboratories and blood blanks looking for new tools to manage blood use may want to look into AI-enabled systems like Triton. Saving money is not the only benefit. Less transfused blood is better for patient care as well. 

—Donna Marie Pocius

Related Information:

New Publication Concludes Gauss Surgical’s Triton System Associated with Earlier Postpartum Hemorrhage Intervention and Reduced Costs

The Association Between the Introduction of Quantitative Assessment of Postpartum Blood Loss and Institutional Changes in Clinical Practice: An Observational Study

Gauss Uses AI to Accurately Measure Blood Loss

Clinical Experience with the Implementation of Accurate Measurement of Blood Loss During Cesarean Delivery: Influences on Hemorrhage Recognition and Allogeneic Transfusion

Special Report: Gauss Surgical

Gauss Raises $20 Million in Series C from Northwell Health and Softbank Ventures Korea for AI-Enabled Platform for the Operating Room

Even as Digital Pathology Is Poised to Be Disruptive in Primary Diagnosis, Most Anatomic Pathology Groups Are Unprepared for How Their Incomes Will Change

Pathologists and practice administrators should prepare a strategy and a timetable for their group’s acquisition and deployment of a digital pathology system and whole slide imaging

Anatomic pathology is a medical specialty at the brink of a major technological disruption. FDA clearance of the first digital pathology system and whole slide imaging (WSI) for primary diagnosis means that every surgical pathologist will soon need to decide when to adopt this technology to avoid declines in group revenue and pathologist compensation.

Not in decades have pathologists faced a comparable dual threat. One threat is the use of digital pathology and WSI for primary diagnosis in ways that deliver faster answers to referring physicians, while creating new business models for anatomic pathology groups. At greatest risk from this technology, however, may be sub-specialist pathologists who depend on specialty referrals and second-opinion consults.

Second Threat Is How Digital Pathology Can Erode Pathology Group’s Revenue

The second threat is how failure to adopt digital pathology and WSI at the right time in the market cycle will put a pathology group’s revenue at risk, while causing pathologist compensation to erode. Pathology groups that are quick to adopt digital pathology and whole slide imaging are expected to gain clinical advantage and additional case referrals, while pathology groups that defer adoption will probably lose market share—and the revenue associated with those lost case referrals.

How Fast Will Pathology Groups Act to Implement Digital Pathology?

It was last April when the FDA cleared the first digital pathology system and whole slide imaging for use in the primary diagnosis of biopsied tissue and resection cases. With clearance to market of the Philips IntelliSite Pathology Solution (PIPS), it is expected that other companies will submit their digital pathology systems for FDA review as well. As that happens, the market for digital pathology systems will expand and become more competitive.

“How fast pathologists in the United States adopt digital pathology for primary diagnosis is the big question,” observed Robert L. Michel, Editor-In-Chief of The Dark Report, Dark Daily’s sister publication. “We’ve interviewed pathologists at several community pathology group practices who currently use digital pathology and whole slide images for things like tumor boards, second opinion consults within and without their practice, and teaching purposes. They have strong opinions about how quickly they want their group to begin using a digital pathology system for primary diagnosis.

“For example, Advanced Pathology Associates (APA) in Rockville, Md., is a group with 15 pathologists who cover seven hospitals,” stated Michel. “APA was the community pathology group site for the study data Philips needed to submit with its FDA pre-market application. They had the system for the nine-month trial and used it to evaluate 500 cases and thousands of glass slides and WSIs. APA returned the system at the conclusion of the study, but pathologists at APA are already in the process of acquiring their own digital pathology system to use for primary diagnosis.”

Anatomic Pathology Group Went Hands-on with Digital Pathology System

In a story The Dark Report published about Advanced Pathology Associates, pathologist Nicolas Cacciabeve, MD, APA’s Managing Partner, commented, “Because we had the opportunity to be hands-on with this digital pathology system, we saw how it changes daily workflow, improves the ergonomics of reading cases, and contributes to increased productivity.”

Cacciabeve identified the immediate benefits APA will accrue after it acquires its own digital pathology system and begins to use it for primary diagnosis. “[Having a digital pathology system] … also opens new opportunities for our pathologists to add more value—whether it is handling more complex cases through real-time consultation, or through better data management and image retrieval, or freeing up pathologists to get out of the lab to collaborate with clinicians.”

Pathologist Clive Taylor, MD, Considers DP’s Clearance to Be ‘Huge’

The FDA’s clearance of the first digital pathology system was called “huge” by noted pathologist Clive Taylor, MD, PhD, a professor of pathology at the Keck School of Medicine at the University of Southern California (where he served as Chair of Pathology from 1984 to 2009) in an interview with The Dark Report published on July 17.

“The FDA’s clearance of this system for primary diagnosis is huge,” stated Taylor. “… I say that because digital slide scanners in many pathology departments around the country are used secondarily. For example, a pathologist will look at a glass biopsy slide today and think, ‘I should scan this to get a score, or an accurate count, or to send it to a colleague in Washington or London or some place.’ In that sense, pathology labs are using whole slide imaging for secondary purposes.

“The FDA clearance of whole slide imaging for primary diagnostics will foster changes in anatomic pathology departments that will improve the accuracy and speed of diagnosis and drastically reduce the time it takes to get second opinions and to reach a primary diagnosis,” Taylor predicted.

Pathologists, Practice Administrators Need a Strategy for Digital Pathology

Because of the potential for digital pathology systems and whole slide imaging to be disruptive to both the clinical practice of pathology and the revenue and income earned by pathologists, it is recommended that pathology practice administrators and pathologist business leaders of their respective groups understand this new technology and how early-adopter pathology labs are using it to add value to their diagnostic services while generating new streams of revenue.

The four expert speakers for this critical Dark Daily webinar are (clockwise from upper left): Keith Kaplan, MD, Chief Medical Officer, Corista, Concord, Mass.; Liron Pantanowitz, MD, Professor of Pathology and Biomedical Informatics at the University of Pittsburgh Medical Center, Pittsburgh; Isaac R. Grindeland, MD, Gastrointestinal Pathology, Incyte Diagnostics, Spokane Valley, Wash.; and Dan Angress, for ClearPath Derm of Dayton, Ohio, and President of Angress Consulting, LLC, Los Angeles, Calif. (Photo copyright: Dark Daily.)

To give practice administrators and interested pathologists this comprehensive knowledge of digital pathology and whole slide imaging, Dark Daily is presenting a special webinar, titled, “Primary Diagnosis with Digital Pathology Systems and Whole Slide Images: What Every Pathologist Needs to Know, Why It Will Be Disruptive, and How Innovative Pathology Groups Are Already Making Money with DP.”

This critical webinar takes place on Thursday, August 17, 2017 at 1:00 PM EDT.

Essential Knowledge about Digital Pathology Systems, Whole Slide Imaging

The webinar is organized to help all pathology groups, academic pathology departments, and pathology laboratories understand:

  • The current capabilities of the technology for digital pathology and WSI;
  • How these technologies are evolving in ways that add functionality and improve productivity; and—most importantly,
  • Two case studies of pathology groups already using digital pathology and WSI imaging to add clinical value and develop new sources of revenue.

Speaking during this webinar will be:

  • Keith Kaplan, MD, Chief Medical Officer, Corista, Concord, Mass.: For nearly a decade, Kaplan has been one of the leading commentators on the use of digital technologies and Web 2.0 capabilities in pathology. He will provide strategic context about why the FDA’s clearance of a digital pathology system for use in primary diagnosis is a trigger event for all pathology groups.
  • Liron Pantanowitz, MD, Professor of Pathology and Biomedical Informatics at the University of Pittsburgh Medical Center, Pittsburgh, Pa.: An internationally known expert on the use of digital pathology systems and whole slide imaging, Pantanowitz will give webinar participants a concise understanding of the technology’s current capabilities; how it is being used at UPMC; the lessons learned in the use of digital pathology to support UPMC’s international pathology collaborations; and what technology advances to expect in the near future.
  • Dan Angress, for ClearPath Derm of Dayton, Ohio, and President of Angress Consulting, LLC, Los Angeles, Calif.: This is a fascinating case study of how ClearPath Derm is using digital pathology capabilities to support added value services for its referring physicians that, most importantly, generate additional revenue for the pathology group.
  • Isaac R. Grindeland, MD, Gastrointestinal Pathology, Incyte Diagnostics, Spokane Valley, Wash.: This regional pathology super-group has 40 pathologists, four anchor locations, and contracts with multiple hospitals. Grindeland will explain how Incyte leverages its digital pathology capabilities to improve productivity and performance, while better meeting the needs of its hospital and physician clients.

Preparing Pathology Groups for Disruptive Potential of DB, WSI

Because of the potential for digital pathology systems and whole slide imaging to disrupt many long-established clinical practices, while at the same time creating new financial winners and losers among the nation’s pathology groups, it is imperative that pathologists and practice administrators gain the necessary knowledge to prepare their groups. Armed with these insights, they then can develop timely and appropriate strategies to ensure their group’s clinical excellence and financial sustainability moving forward.

For details about the August 17 webinar and to register, use this link (or copy this URL and paste it into your browser: https://ddaily.wpengine.com/webinar/primary-diagnosis-with-digital-pathology-systems-and-whole-slide-images-what-every-pathologist-needs-to-know-why-it-will-be-disruptive-and-how-innovative-pathology-groups-are-already-making-money-w).

—Michael McBride

Related Information:

Primary Diagnosis with Digital Pathology Systems and Whole Slide Images: What Every Pathologist Needs to Know, Why It Will Be Disruptive, and How Innovative Pathology Groups Are Already Making Money with DP

FDA Allows Marketing of First Whole Slide Imaging System for Digital Pathology

Whole Slide Imaging In Pathology: Advantages, Limitations, and Emerging Perspectives

Digital Images and the Future of Digital Pathology, Liron Pantanowitz, MD

Philips Awarded FDA Clearance for Digital Pathology Solution for Primary Diagnostic Use

What Does FDA Approval of a Digital Pathology System for Use in Primary Diagnosis Mean for the Pathology Industry? New Dark Daily Webinar to Provide Answers and Insights for Pathologists and Pathology Practice Administrators

Dark Daily Story on Pathology 2.0 and Digital Pathology Blog

 

Two FDA Inspection Reports Show Theranos’ Blood-Collection ‘Nanotainer’ Was an Uncleared Class II Medical Device

FDA details findings from visits by five federal inspectors at California clinical lab company over 10 days in late August and early September; heavily redacted reports outline 14 compliance deficiencies

Two reports released Tuesday by the Food and Drug Administration (FDA) brought more bad news to Theranos, of Palo Alto, California. The clinical laboratory company has been the subject of much unwanted press coverage since October 15. In the FDA inspection reports, Theranos is required to explain or correct each of 14 “inspectional observations.”

Pathologists, clinical laboratory scientists, and in vitro company executives who take the time to read both FDA reports about the federal agency’s inspection of Theranos will find insights into how FDA assessors view the lab company’s compliance with FDA regulations and requirements. There were 14 issues described in the two FDA reports.

FDA Said Theranos Nanotainer Blood-Collection Container Is Class II Medical Device (more…)

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