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

Hosted by Robert Michel
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CDC Ranks Two More Drug-Resistant Microbes as ‘Urgent Threat’ to Americans; Clinical Laboratories Are Advised to Increase Awareness of Antimicrobial Resistance

In a separate study, HHS finds a 40% increase in sepsis cases, as more patients succumb to infections without effective antibiotics and antimicrobial drugs

Given the drastic steps being taken to slow the spread of the Coronavirus in America, it’s easy to forget that significant numbers of patients die each year due to antibiotic-resistant bacteria (ARB), other forms of antimicrobial resistance (AMR), and in thousands of cases the sepsis that follows the infections.

This is why the Centers for Disease Control and Prevention (CDC) issued the report “Antibiotic Resistance Threats in the United States, 2019 (2019 AR Threats Report)” last fall. The federal agency wants to call attention the emergence of new antibiotic-resistant bacteria and fungi. In its report, the CDC lists 18 bacteria and fungi that pose either urgent, serious, or concerning threats to humans. It also placed one fungus and two bacteria on a “watch” list.

The CDC’s website states that “more than 2.8 million antibiotic-resistant infections occur in the US each year, and more than 35,000 people die as a result.” And a CDC news release states, “on average, someone in the United States gets an antibiotic-resistant infection every 11 seconds and every 15 minutes someone dies.”

Those are huge numbers.

Clinical laboratory leaders and microbiologists have learned to be vigilant as it relates to dangerously infectious antimicrobial-resistant agents that can result in severe patient harm and death. Therefore, new threats identified in the CDC’s Antibiotic Resistance Threats in the United States report will be of interest.

Drug-resistant Microbes That Pose Severe Risk

The CDC has added the fungus Candida auris (C. auris) and carbapenem-resistant Acinetobacter (a bacteria that can survive for a long time on surfaces) to its list of “urgent threats” to public health, CDC said in the news release. These drug-resistant microbes are among 18 bacteria and fungi posing a greater threat to patients’ health than CDC previously estimated, Live Science reported.

In 2013, the CDC estimated that about two million people each year acquired an antibiotic-resistant (AR) infection that killed as many as 23,000. However, in 2019, the CDC reported that those numbers were low and that the number of deaths due to AR infections in 2013 was about twice that amount. During a news conference following the CDC announcement, Michael Craig (above), a Senior Adviser for the CDC’s Antibiotic Resistance Coordination and Strategy Unit said, “We knew and said [in 2013] that our estimate was conservative … and we were right,” Live Science reported. In 2019, CDC reported 2.8 million antibiotic-resistant infections annually with more than 35,000 related deaths in the US alone. (Photo copyright: Centers for Disease Control and Prevention.)

The CDC considers five threats to be urgent. Including the latest additions, they are:

Dark Daily has regularly covered the healthcare industry’s ongoing struggle with deadly fungus and bacteria that are responsible for hospital-acquired infections (HAI) and sepsis. This latest CDC report suggests healthcare providers continue to struggle with antimicrobial-resistant agents.

Acinetobacter Threat Increases and C. auris a New Threat since 2013

Carbapenem-resistant Acinetobacter, a bacterium that causes pneumonia and bloodstream and urinary tract infections, escalated from serious to urgent in 2013. About 8,500 infections and 700 deaths were noted by the CDC in 2017. 

C. auris, however, was not addressed in the 2013 report at all. “It’s a pathogen that we didn’t even know about when we wrote our last report in 2013, and since then it’s circumvented the globe,” said Michael Craig, Senior Adviser for the CDC’s Antibiotic Resistance Coordination and Strategy Unit, during a news conference following the CDC announcement, Live Science reported.

Today, C. auris is better understood. The fungus resists emerging drugs, can result in severe infections, and can be transmitted between patients, CDC noted.

Last year, Dark Daily reported on C. auris, noting that as of May 31 the CDC had tracked 685 cases. (See, “Potentially Fatal Fungus Invades Hospitals and Public Is Not Informed,” August 26, 2019.)

By year-end, CDC tracking showed 988 cases in the US.

More Patients Getting Sepsis as Antibiotics Fail: HHS Study

In a separate study published in Critical Care Medicine, a journal of the Society of Critical Care Medicine (SCCM), the US Department of Health and Human Services  (HHS) found that antibiotic-resistant bacteria and fungi are resulting in more people acquiring sepsis, a life-threatening condition, according to an HHS news release.

Sepsis increased by 40% among hospitalized Medicare patients from 2012 through 2018, HHS reported.   

“These (untreatable infections) are happening here and now in the United States in large numbers. This is isn’t some developing world thing. This isn’t a threat for 2050. It’s a threat for here and now,” Cornelius “Neil” Clancy, MD, Associate Chief of Veterans Affairs Pittsburg Health System (VAPHS) and Opportunistic Pathogens, told STAT.

It is troubling to see data about so many patient deaths related to antibiotic-resistant infections and sepsis cases when the world is transfixed by the Coronavirus. Nevertheless, it’s important that medical laboratory leaders and microbiologists keep track of how the US healthcare system is or is not responding to these new infectious agents. And, to contact infection control and environmental services colleagues to enhance surveillance, ensure safe healthcare environments and equipment, and adopt appropriate strategies to prevent antibiotic-resistant infections.   

—Donna Marie Pocius

Related Information:

CDC:  Biggest Threats and Data: 2019 Antibiotic Resistance Threats in the United States

More People in the U.S. Dying from Antibiotic-Resistant Infections Than Previously Estimated; Significant Progress Since 2013 Could be Lost Without More Action

These Two Drug-Resistant Microbes Are New “Urgent Threats” to Americans’ Health

CDC Report: 35,000 Americans Die of Antibiotic-Resistant Infections Each Year

The Superbug Candida Auris is Giving Rise to Warnings and Big Questions

On the Emergency of Candida Auris Climate Change, Azoles, Swamps, and Birds

Largest Study of Sepsis Cases Among Medicare Beneficiaries Finds Significant Burden

Sepsis Among Medicare Beneficiaries: The Burdens of Sepsis 2012 to 2018

Dark Daily: Hospital-Acquired Infection

Potentially Fatal Fungus Invades Hospitals and Public is Not Informed

Leapfrog Group Report Shows Hospitals Failing to Eliminate Hospital-Acquired Infections; Medical Laboratories Can Help Providers’ Antimicrobial Stewardship Programs

Contrary to CMS and Joint Commission programs implemented in 2017 to reduce them, incidents of hospital-acquired infections have risen for the past few years

Clinical laboratories and anatomic pathologists know that hospital-acquired infections (HAIs) can be deadly, not just for patients, but for their caregivers and families as well. Even one HAI is too many. Thus, the federal Centers for Medicare and Medicaid Services (CMS) required healthcare organizations to upgrade their antimicrobial stewardship (AMS) programs to meet CMS requirements and Joint Commission accreditation starting in 2017.

Nevertheless, a recent Leapfrog Group report indicates hospitals are finding it increasingly difficult to remove infections all together. This has many healthcare leaders concerned.

The report, which was analyzed by Castlight Health, states that the number of hospitals reporting zero infections has declined significantly since 2015, according to a news release. According to the Leapfrog Group’s report:

  • Two million people acquire HAIs every year;
  • 90,000 people die annually from HAIs;
  • HAI costs range from $1,000 to $50,000 depending on the infection.

Hospitals spend $28 to $45 billion annually on HAI costs, Healthcare Finance reported.

“I think it’s far too easy to let something slip, so it’s clear that there really needs to be a renewed focus on getting back to zero. We do still see some hospitals that are getting to zero, so it’s clearly possible,” Erica Mobley (above), Leapfrog Group’s Director of Operations, told Fierce Healthcare. (Photo copyright: LinkedIn.)

Regressing Instead of Progressing Toward Total HAI Elimination

Leapfrog Group’s report is based on 2017 hospital survey data submitted by 2,000 providers. The data indicates that in just two years the number of hospitals reporting zero HAIs dropped by up to 50%. The reported HAIs include:

The remaining infection measures studied by Leapfrog Group had less dramatic decreases over the same time period, according to Fierce Healthcare. Nevertheless, they are significant. They include:

  • Surgical site infections (SSI) following colon surgery: 19% zero infections compared to 23% previously;
  • Clostridium difficile (C. difficile) inpatient infections: 3% zero inpatient infections in 2017, compared to 5% in 2015.

Joint Commission Studies Antimicrobial Program Progress

Meanwhile, the Joint Commission acknowledged that implementation of antimicrobial stewardship programs by providers can be difficult. In “The Expanding Role of Antimicrobial Stewardship Programs in Hospitals in the United States: Lessons Learned from a Multisite Qualitative Study,” the accrediting organization released insights from interviews with 12 antimicrobial stewardship program leaders nationwide.

They published their study in “The Joint Commission Journal on Quality and Patient Safety.” Three themes emerged from the interviews:

  • Hospitals have revised their antimicrobial programs, which originally operated on a “top-down” structure, to programs that include clinicians from throughout entire provider organizations;
  • Health information technology (HIT) can enable real-time opportunities to launch antimicrobial therapy and treat patients; and,
  • Some barriers exist in getting resources to integrate technology and analyze data.

“These programs used expansion of personnel to amplify the antimicrobial stewardship programs’ impact and integrated IT resources into daily workflow to improve efficiency,” the researchers wrote. “Hospital antimicrobial stewardship programs can reduce inappropriate antimicrobial use, length of stay, C. difficile infection, rates of resistant infections, and cost.”

What Do CMS and Joint Commission Expect?

According to Contagion, while the Joint Commission program is part of medication management, CMS places its requirements for the antimicrobial stewardship program under “infection prevention.”

CMS requirements for an antimicrobial stewardship program include:

  • Developing antimicrobial stewardship program policies and procedures;
  • Implementing hospital-wide efforts;
  • Involving antimicrobial stakeholders for focus on antimicrobial use and bacterial resistance;
  • Setting evidence-based antimicrobial use goals; and,
  • Reducing effects of antimicrobial use in areas of C. difficile infections and antibiotic resistance.

Leapfrog Group’s data about fewer hospitals reporting zero infections offers opportunities for hospital laboratory microbiology professionals to get involved with hospital-wide antimicrobial program teams and processes and help their hospitals progress back to zero HAIs. Clinical laboratories, both hospital-based and independent, also have opportunities to contribute to improving the antimicrobial stewardship efforts of the physicians who refer them specimens.

—Donna Marie Pocius

Related Information:

Troubling New Report on Hospital Infections Comes While Centers Medicare and Medicaid Services Considers Discontinuing Publicly Reporting Rates

Leapfrog Group: Healthcare-Associated Infections

Antimicrobial Stewardship Standards: A Comparison of Centers for Medicare and Medicaid Services and Joint Commission Requirements

Joint Commission: New Antimicrobial Stewardship Standard

Core Elements of Hospital Antibiotic Stewardship Programs

Number of Hospitals Achieving Zero Infections Drops

Hospitals Losing Ground on Effectively Preventing Infections with Dramatic Drop in Those Reporting Zero Infections

The Expanding Role of Antimicrobial Stewardship Programs in Hospitals in the United States: Lessons Learned from a Multi-Site Qualitative Study

University of Nebraska Infectious Disease Researchers Study New Device That Could Help Clinical Laboratories and Phlebotomists Avoid Blood Culture Contamination and False Positive Results for Sepsis

Additionally, the device also could help reduce antibiotic-resistant infections and other HAIs and HACs, though this result was not part of the study

Research findings indicate how a new system-in-a-box device that phlebotomists and clinical laboratories would use when drawing blood could reduce contamination of blood cultures and lower patients’ use of antibiotics. In a study involving 1,800 blood cultures done on 904 patients at the University of Nebraska Medical Center (UNMC), use of the device was attributed to an 88% reduction in the blood culture contamination rate.

Developed by Magnolia Medical Technologies, the SteriPath Initial Specimen Diversion Device (ISDD) is compatible with standard BD and bioMérieux blood collection tubes and culture bottles, and has been approved by the US Food and Drug Administration (FDA) for marketing in the United States.

According to a press release by researchers at UNMC who studied the device, “With traditional blood draws, about 30% to 40% of patients with contaminated blood cultures are prescribed antibiotics unnecessarily. This contributes to antibiotic resistance and undermines nationwide efforts to improve antimicrobial stewardship.” The researchers reported their findings in an article published in the Oxford Academic journal Clinical Infectious Diseases (CID).

Blood Culture Contamination Harms Patients and Increases Cost of Care

The UNMC researchers noted that, during a blood draw, a significant percentage of blood cultures become contaminated when skin fragments containing bacteria are dislodged and mix with the patient’s blood. For the thousands of patients each day who have their blood drawn, contaminated blood cultures, which lead to false positive results for sepsis, often result in unnecessary antibiotic treatment. This in turn can lead to serious and deadly antibiotic-resistant infections with various multi-drug-resistant organisms such as Clostridium difficile infection (C. diff), as well as, other hospital-acquired infections and conditions (HAIs & HACs) due to unnecessary extended length of stay, according to Mark Rupp, MD, Professor, Department of Internal Medicine, Section of Infectious Diseases, and Medical Director, Department of Healthcare Epidemiology-Infection Control at UNMC.

In the CID article, Rupp and colleagues reported on a prospective, controlled trial conducted in the emergency department (ED) at UNMC’s partner hospital Nebraska Medicine. Results of the trial showed that the SteriPath ISDD diverts and sequesters the first 1.5 to 2 mL portion of blood. The researchers presumed that these initial drops of blood would contain the contaminating skin cells and microbes.

SteriPath is a self-contained, preassembled, sterile blood collection system. It provides proprietary vein-to-bottle technology that significantly reduces blood culture contamination, according to Magnolia Medical Technologies. This could be useful for helping phlebotomists and clinical laboratories improve the quality of specimens collected for use in blood culture testing. Click on the image above to view videos on the SteriPath ISDD. (Photo copyright: Magnolia Medical Technologies.)

The researchers tested the SteriPath ISDD during standard phlebotomy procedures in patients requiring blood cultures. After drawing 1,808 blood cultures from 904 study subjects, the researchers concluded that the ISDD significantly reduced blood culture contamination compared with standard phlebotomy procedures. The blood culture contamination among phlebotomists who used the ISDD decreased by nearly 90%, compared to phlebotomy procedures conducted by nurses who did not use the ISDD.

“We were able to decrease the false positive rate significantly through use of this device—from 1.78% down to 0.2%, which represents an 88% reduction,” Rupp noted in the UNMC press release. “The 1.78% baseline rate of contamination may seem small, but we should strive to decrease adverse events to the lowest possible level, because of the impact to the patient and the burden to our healthcare system.

“The device is innovative in that it diverts the first couple of milliliters of blood into the sequestration chamber,” Rupp explained. “That’s where we think the contaminants are. The remaining blood being drawn is then diverted into the sterile pathway into the blood culture vial, thereby preventing the contamination.”

Billions of Healthcare Dollars Could Be Saved with SteriPath’s ISDD

During a conference call with reporters, Rupp admitted that cynics might scoff at such a low rate of improvement. “Many of those folks don’t understand that we do tens of millions of blood cultures in this country every year,” he explained. “Every year, we do about 30 million or so blood cultures. That many cultures means a 2% contamination rate equates to somewhere in the neighborhood of about 600,000 contamination events. And 2% is a very respectable level. Usually clinicians are satisfied anywhere below about 3%, which is about 900,000 events each year.”

For about 40% to 50% of patients whose blood is contaminated, physicians will prescribe antibiotics, order another blood test, and require patients to stay several days in the hospital, he added. “All of this results in thousands of extra dollars being spent,” he declared. If each blood contamination case costs about $4,000, then reducing such contamination in potentially 600,000 cases each year could save more than $1 billion healthcare dollars.

According to the researchers, costs associated with blood culture contamination ranged from $1,000 per patient in 1998 to $8,700 per patient in 2009. “If a midpoint cost estimate of $4,850 is used, and the added cost of the device is not taken into account, it equates to a cost avoidance of $1.8 million per year at our institution alone,” Rupp stated. “If the low rate of contamination that we observed in the study, 0.22%, was applied to all blood cultures throughout the country, billions of dollars of excess costs could be avoided.”

This clinical study offers strong evidence that the SteriPath ISDD might prove to be a useful tool that clinical laboratories could use to help prevent unnecessary exposure to antibiotics and hospital stays, lower healthcare costs, and improve patient test outcomes. If the UNMC clinical study outcomes are replicated in future studies, then it is a technology and a solution that has the potential to be adopted by phlebotomists in medical laboratories and hospitals.

—Joseph Burns

 

Related Information:

Reduction in Blood Culture Contamination Through Use of Initial Specimen Diversion Device

Study Shows Device Reduces Blood Draw Contamination

Novel Device Significantly Reduces Blood Draw Contamination, Reduces Risks to Patients, Study Shows

Better Care by Reducing Blood Culture Contamination: Sepsis, SteriPath and Antimicrobial Stewardship

Study by Mark Rupp, MD, in Clinical Infectious Diseases: Reduction in Blood Culture Contamination Through Use of Initial Specimen Diversion Device (SteriPath)

Big Data Projects at Geisinger Health Are Beginning to Help Physicians Speed Up Diagnosis and Improve Patient Care

While many of the major gains promised by electronic health records (EHRs) and big data remain elusive, Geisinger Health’s Unified Data Architecture demonstrates how big data might help healthcare providers and clinical laboratories optimize care, improve outcomes, and control costs as the technology evolves

Use of big data in healthcare gets plenty of hoopla these days. Many experts predict great things as clinical laboratory test data is pooled with other patient information and demographic data. But there are many technical problems to be overcome before the full potential of healthcare big data can be translated into ways that improve the health of individuals.

Big data in healthcare is essential to the success of both precision medicine and population health management. However, without the ability to consolidate other data sources and provide intuitive ways for healthcare providers to access, analyze, and utilize the data coming from the various sources, such as clinical laboratory and anatomic pathology test results, much of the data can be underutilized or overlooked.

Medical laboratories continue to generate increased amounts of data, much of which often finds its way into electronic health record (EHR) systems and other data silos. A Harvard Business Review (HBR) report from doctors at Geisinger Health in Pennsylvania shows how this data might be used.

Consolidating Data to Create Cohesive Snapshots of Patient Health

The HBR report attributes Geisinger’s ability to utilize big healthcare data to its Unified Data Architecture (UDA). According to a Healthcare Informatics article, Geisinger’s UDA was based on Hadoop and other open source software. According to the doctors who wrote the HBR report, “… pulling meaningful data aggregated from many sources back out of EHRs has historically been vexingly complex. The potential insight from these data are limited in practice by the shortcomings of traditional data repositories.”

Geisinger’s UDA addresses two key issues the Healthcare Informatics authors see as obstacles to the expanded, easier use of big healthcare data:

  1. Lack of ways to deal with unstructured patient notes that do not adhere to traditional database organizational structures; and
  2. Data silos created when multiple departments collect data but use separate storage systems.

Using natural language processing (NLP), the UDA system can pull critical information from long-form written reports or analyses.

Big data graphic above from Nuance, developer of intelligent systems for healthcare and other industries, illustrates the challenges involved in acquiring, sifting, managing, and utilizing big data in healthcare. (Graphic copyright: Nuance.)

Geisinger’s system connects nurses on the floor, medical technologists in the clinical laboratory, and surgeons in operating rooms to the same pools of data. However, it also pulls in data from external sources, such as pathology groups, other reference or medical laboratories, and even patient-worn mobile medical devices. The HBR report states, “The integration of data from Health Information Exchanges, clinical departmental systems (such as radiology and cardiology), patient satisfaction surveys, and health and wellness apps provides us with a detailed, longitudinal view of the patient.”

Big Data Helps Healthcare Professionals Spot Future Worries

Geisinger’s Abdominal Aortic Aneurysm (AAA) Close the Loop Program—named semi-finalists in Healthcare Informatics’ 2016 Innovator Awards Program—is an example of how NLP and data collation offers benefits often overlooked with traditional approaches.

Geisinger doctors found that AAAs typically are discovered during care for another condition. Often, the conditions for which the patient seeks care are more serious than the small AAA and it isn’t mentioned. While AAAs might be noted in patient records, healthcare providers typically do not look for the data. Thus, left untreated, a AAA can develop into a serious condition that could have been prevented.

NLP enables Geisinger doctors to analyze UDA data for warning signs of AAA and create follow-up and treatment plans that might otherwise remain overlooked. According to the HBR report, this program has led to 12 lifesaving operations to date that might otherwise have been missed.

Real-Time, Comprehensive Updates Offer Big Gains in Combating Sepsis

Big healthcare data shows potential for treating many life-threatening conditions, such as sepsis. Prompt treatment is essential to positive outcomes in sepsis cases. Physicians at Geisinger use the company’s UDA data to both pinpoint when sepsis indicators appeared, as well as to consolidate data from across a patient’s care continuum to optimize treatment.

Instead of sorting through disparate streams of data from various operational areas and reports, data is combined into a consolidated dashboard featuring real-time physiologic metrics, such as:

  • Blood pressure measurements;
  • Blood culture results; and
  • Antibiotic administration.

The HBR report notes, “By tracking, aggregating, and synthesizing all sepsis-patient data, we expect we will be able to both reduce the incidence of hospital-acquired sepsis and improve its management.”

Using Big Data to Track Surgical Supply Chains and Waste

With the unique cost and outcome aspects of each surgical case, and the differences in payouts from payers, creating big data for tracking the efficiency and waste of surgeries is difficult without a big picture view of the factors. Using their UDA, Geisinger can track the exact supplies used in an operation along with the outcome, recovery, cost, and follow-up data related to the procedure.

“This gives surgeons and administrators an important new view of how they perform comparatively from both a cost and outcome perspective,” noted the HBR report’s authors.

Big data is still a developing technology. Nevertheless, programs such as at Geisinger Health offer useful lessons into how data streaming from clinical laboratories, pathology assays, operating rooms, intensive care units, and even personal health-tracking devices might be combined to provide a unified patient record. That would make it possible for caregivers to use analytical tools to tailor each patient’s care and treatment to his or her specific conditions and physiology.

—Jon Stone

Related Information:

How Geisinger Health System Uses Big Data to save Lives

How Unleashing Trapped Clinical Data Has Saved Lives at Geisinger Health System

The 2016 Healthcare Informatics Innovator Awards Program: Semifinalists

Unified Data Architecture Allows Patient Insights

At Geisinger Health System, Advanced Analytics Pave the Way to Better Outcomes

New Geisinger Initiative Digs Deep into the Wild, Unstructured World of Big Data

Geisinger Reaps System-wide Benefits with Big Data Approach

Is mHealth an Opportunity or Threat to Medical Laboratories and Pathology Groups?

As cognitive and cloud computing continue to advance, and mobile technologies become more accessible across the globe, innovative apps and mobile attachments are using algorithms to replace the need for complex and time-consuming diagnostic tests

Mobile healthcare—also known as mHealth—is attracting plenty of research dollars as entrepreneurs look for ways improve consumers’ access to various medical services in ways that could reduce healthcare costs. For that reason, some mHealth solutions may be used by clinical laboratories and pathology groups to give patients faster access to diagnostic services and information about medical laboratory tests.

Most mHealth solutions excel at doing a single, defined task well. In some cases, they are faster and as accurate as human-based testing or observation. However, few solutions can tackle complex diagnostics, such as determining the pathogens involved in sepsis. And mHealth cannot replace the human element of communication and empathy, which will always have a place in the medical process. (more…)

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