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

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

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Innovators Develop Multi-Analyte Pulse Oximeters That Accurately Read Oxygen Levels in People with Darker Skin Pigmentation

Multiple studies have shown that people with darker skin pigmentation run a higher risk of being misdiagnosed and undertreated than patients with lighter skin due to inaccurate oxygen level readings

Though pulse oximeters are not a standard clinical laboratory device, clinical laboratory scientists (aka, medical technologists) know of them and understand their function, particularly with hospital patients.

Now, scientists at multiple institutions are working to improve the basic pulse oximeter’s design by making it capable of measuring multiple biomarkers, as well as addressing long-standing inaccuracies in the device when used on people with darker skin pigmentation.

This ongoing research demonstrates how new technologies are enabling innovators to add useful functions to standard, well-accepted devices.

Valencia Koomson, PhD

Valencia Koomson, PhD (above), Associate Professor, Electrical and Computer Engineering, and head of the Advanced Integrated Circuits and Systems Lab at Tufts University, has developed a pulse oximeter that measures oxygenation in tissue, rather than in blood. Her approach could ensure patients with darker skin pigmentation will be accurately diagnosed at the point-of-care. Though generally not used in clinical laboratory settings, medical technologists will be interested to learn of these new innovations in pulse oximeters. (Photo copyright: Tufts University.)

Measuring Tissues Instead of Blood

The pulse oximeter—a device that attaches to a person’s finger—uses red and infrared light to measure blood oxygen saturation (SpO2) and display pulse rate.

Studies in 2022 that looked into how hospitals administered oxygen to different patients found that inconsistent pulse oximeter readings could cause caregivers to administer less oxygen than is actually needed to people with darker skin pigmentation.

This is because melanin in the skin can interfere with “absorption of light used to measure oxygenated blood in a person’s finger,” according to a National Science Foundation (NSF) news story. Such inaccurate pulse oximeter readings can lead to “inaccurate readings and poorer treatment outcomes” for people with dark skin tones, the NSF wrote.

“Addressing this problem will require innovation in pulse oximeter design and revised regulatory standards,” said Valencia Koomson, PhD, Associate Professor, Electrical and Computer Engineering, Tufts University, Medford, Massachusetts, in the NSF news story.

Koomson, who leads the Advance Integrated Circuit and Systems Lab at Tufts, has developed a prototype pulse oximeter device, which NSF explained, measures oxygenation in biological tissues instead of blood.

NSF supports her pulse oximeter research through the National Science Foundation Partnerships for Innovation (PFI) program.

“My lab’s work on pulse oximeter devices will provide an alternative technology to address many confounding factors that affect pulse oximeter accuracy, including skin pigmentation, motion artifact, and others,” Koomson said.

National Public Radio (NPR) said Koomson’s device has built-in “technology that can measure a person’s skin tone.”

“We can send more light if there’s a higher level of melanin present, so that melanin doesn’t become a confounding factor that obscures our results,” Koomson told NPR.

Another Pulse Oximeter Redesign

Another new approach to pulse oximetry was developed at Brown University in Providence, Rhode Island.

Rutendo Jakachira, Research Assistant, School of Engineering, and a PhD student in physics, turned to new optical techniques to address the challenge of oxygen saturation levels in dark skin tones, according to a Brown University news release.

Jakachira and Kimani Toussaint, PhD, Professor of Engineering and Senior Associate Dean in the School of Engineering, say they have created possibly the first LED-based light source to emit radially polarized light.

When the LED passes light through a person’s finger, the device calculates the amount of light the hemoglobin in the blood absorbed, NPR explained.

“We did a preliminary study on about five people, and although it was a small study, the results are promising,” said Jakachira, who plans a larger study and clinical trial. 

Study Suggests Patients with Darker Skin May Have Received Delayed COVID-19 Care

Meanwhile, a study published in the American Journal of Epidemiology (AJE) suggested pulse oximeter errors may have led to a 4.5-hour delay in COVID-19 treatment of patients with darker skin pigmentation, according to a news release from the University of California San Francisco.

The researchers analyzed electronic health record (EHR) data from 43,753 patients at Sutter Health in Sacramento, California, who had SpO2 measurements done between January 2020 and February 2022, and 8,735 patients seen for COVID-19 between July 2020 and February 2021 in the hospital’s emergency department.

In their AJE paper, they wrote, “We investigated whether or not pulse oximetry systematically underestimated oxygen saturation in patients who identified as NHB [non-Hispanic Black/African-American] as compared with NHW [non-Hispanic White] counterparts. We also assessed whether or not differences in oxygen saturation measurement affected hospital admission, care delivered, or return to the hospital post discharge among patients with COVID-19.

“We found evidence of differential pulse oximeter measurement error in NHB individuals, resulting in nonrandom overestimation of blood oxygenation as compared with NHW individuals. NHB individuals were also more likely to have hypoxemia [abnormally low oxygen levels in the blood] not detected by pulse oximetry.

“For NHB patients presenting in the ED with COVID-19, we found that overestimation of oxygen saturation was associated with underestimation of the need for admission and underestimation of the need for treatment with dexamethasone and supplemental oxygen. Additionally, we observed associated delays in dexamethasone initiation and initiation of oxygen supplementation.

“There are also broader implications beyond COVID-19, as differential pulse oximeter accuracy has the potential to exacerbate disparities for any condition that relies upon blood oxygenation measurement to inform clinical decision-making.”

Importance of Accurate Readings

Developing pulse oximeters that are accurate for all people, regardless of skin tone, is clearly an important breakthrough. Medical laboratory leaders and pathologists recognize that SpO2 data—along with clinical laboratory test results—are critical for successful diagnostics and treatment. Thus, new technologies that add useful functions to well-accepted devices are positive developments and worth watching.    

Donna Marie Pocius

Related Information:

Researcher Addresses Longstanding Problem with Pulse Oximeters and Dark-skinned Patients

When it Comes to Darker Skin, Pulse Oximeters Fall Short

Brown PhD Student Working to Correct Skin Color Bias in Pulse Oximeters

Pulse Oximeters Don’t Work as Well on Darker Skin, Leading to Flawed COVID-19 Care

Racial Disparities in Pulse Oximeter Device Inaccuracy and Estimated Clinical Impact on COVID-19 Treatment Course

Medicare Program Officials Affirm Meaningful Use Stage Three to Continue Even As the Agency Moves to Implement MACRA’s Value-Based Payment Law

Clarification comes just a week after one CMS official had discussed the end of Meaningful Use at a conference in San Francisco

Talk about mixed messages! Is the federal Meaningful Use (MU) program about to end? Or is it going to continue and evolve in significant new ways?

Alert pathologists and clinical laboratory executives may have picked up on the conflicting statements about the future plans for Meaningful Use that have been made in recent weeks by certain officials from the Centers for Medicare and Medicaid Services (CMS).

Because thousands of hospitals and hundreds of thousands of physicians have made substantial capital investments in electronic health records to qualify for federal incentives, any major change to the Meaningful Use requirements will have broad consequences.

Medical laboratories have a big stake in this issue as well, since they must invest substantial money into creating the interfaces needed to connect their labs’ laboratory information systems (LIS) to the EHRs of client hospitals and physicians. (more…)

Many Hospitals and Health Systems Report Flat or Falling Rates of Inpatient Admissions, a Trend that Causes Hospital Laboratory Budgets to Shrink

Weaker finances at the nation’s hospitals causes administrators to further shrink the budgets for clinical laboratory and anatomic pathology services

Hospital admissions across the country continue to be flat or in decline over recent years. The result is less revenue for many hospitals. As a result, administrators continue to shrink the budgets of hospital service lines—including clinical laboratory services. For pathologists and clinical laboratory leaders, this poses the challenge of setting innovative strategies that take into account the changes in payment and delivery models.

Hospital Inpatient Admissions Have Been Declining over Recent Years

Modern Healthcare (MH) recently published a story on the declining inpatient admissions trend. The story, written by Rachel Landen, focused on admission rates at thirteen large hospital systems for the third quarter of 2014. These included: (more…)

Adoption of Quality Management Systems Could Mean Competitive Advantage for Clinical Pathology Laboratories

ISO 15189 is a quality management system  specifically designed for the needs of medical laboratories

Use of quality management systems (QMS) by innovative clinical laboratories and pathology groups enables them to drive impressive gains in quality, customer satisfaction, and financial performance. This is a key development at a time when medical laboratory budgets are shrinking and more cuts in lab test prices are expected.

Going the Extra Mile to Improve Quality Could Be Strategic Opportunity

On all fronts of laboratory medicine, requirements are becoming more stringent. Each year, labs find themselves held to higher standards for compliance with both Clinical Laboratory Improvement Act (CLIA) requirements and Medicare accreditation guidelines. This situation will become further complicated as clinical labs face the need to also meet the requirements of accountable care organizations (ACOs) and similar models of integrated clinical care. Early adopters are responding to these marketplace dynamics by making strategic use of a QMS to boost the performance of their clinical laboratory organizations. As they do, they often gain a competitive advantage. (more…)

Modern Healthcare’s Top 10 Largest Health System Rankings also Reveal Nation’s Largest Hospital-Based Laboratories

These annual rankings show that the nation’s largest healthcare systems continue to grow in revenue and bed count

When it comes to the nation’s largest healthcare systems, it is no surprise that the U.S. Department of Veterans Affairs (VA) tops the list, at least when ranked by annual revenue. That is the finding of a “Top 10” survey of healthcare systems recently published by Modern Healthcare magazine.

This survey is useful to pathologists and clinical laboratory managers because these “Top 10” healthcare system rankings also provide insight as to where the nation’s largest hospital-based laboratory organizations can be found. For example, the VA operates 164 acute-care hospitals. That represents a large volume of clinical laboratory testing for those inpatients.

(more…)

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