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FDA Raises the Bar for Flu Tests, Aiming for Better Testing and Better Outcomes
Clinical Lab Products, October 2017, By K.C. McGrath

A Note about Influenza . . .
US public health officials strongly urge annual influenza vaccination for everyone beginning at age 6 months, but coverage rates are far from optimal. Nearly 6 in 10 US adults and 4 in 10 US children skip the annual inoculation.


Furthermore, vaccination lowers the risk of infection, but does not eliminate it completely. Influenza vaccine effectiveness has been estimated from a low of 10% during the 2004–2005 season to a high of 60% during the 2010–2011 season.


Such modest efficacy levels coupled with high rates of vaccine avoidance mean tens of millions of Americans will become infected and descend on the healthcare system every winter respiratory season.

Read more >

FDA’s recent regulatory reclassification of antigen-based rapid influenza diagnostic tests (RIDTs) from Class I to Class II was prompted by concerns about the tests’ performance during severe flu seasons, most notably during the H1N1 influenza pandemic of 2009. The goal of the reclassification is to improve point-of-care influenza testing, in order to reduce misdiagnoses and accelerate linkage to appropriate treatment.


Influenza virus marked by ongoing mutation

The significant burden of influenza makes this goal important not only for patients, but also for the public health, broadly defined. Flu is associated with a worldwide annual attack rate of 5% to 10% among adults, and 20% to 30% among children. In the United States, the Centers for Disease Control and Prevention (CDC) estimates that there are between 9 million and 60 million cases every year, leading to 140,000 to 710,000 inpatient hospital stays and between 12,000 and 56,000 deaths.

Rapid and accurate diagnosis followed by connection to appropriate treatment can help to reduce the substantial morbidity and mortality associated with influenza, and potentially, its direct costs. It can also help to reduce inappropriate antibiotic prescriptions, improve influenza infection control procedures, and reduce rates of repeat doctor visits. Reducing inappropriate use of antibiotics, in particular, has very wide implications, as antibiotic misuse is a key driver of antimicrobial resistance, a significant and growing public health threat.

The Rationale for Reclassification
FDA’s device classification system reflects the regulatory controls needed to ensure that devices are safe and effective for human use.


There are three device classifications based on risk: Class I, Class II, and Class III. All three classes of devices must satisfy basic requirements specified by FDA (‘general controls’), such as proper packaging and labeling. Read more >

The Journey to 100% Point-of-Care Connectivity
Clinical Laboratory News, October 2017, By Christiane Nooney, MHA/MBA, MT(AMT)

At first glance, the need for centralized connectivity of point-of-care (POC) instruments may seem conceptually at odds with the primary benefit these devices provide. Indeed, caregivers generate results and may well have acted on them by the time POC staff can view test data on their middleware server.

Nonetheless, the value of POC connectivity has risen steadily in concert with the growing importance of informatics in care delivery. Connectivity not only facilitates dissemination of clinical data to caregivers across the house but also provides numerous advantages to laboratorians under the broad heading of compliance management.

POC connectivity enables labs to keep central oversight of quality control (QC), device management, and user database and competency management, while also supporting automated billing. Put simply, POC connectivity enhances POC staff productivity and helps manage a growing POC program without the need to increase staff.


Unlike hospital laboratories...  Read more >

The Role of Lab Automation in Reducing Diagnostic Errors
Medical Laboratory Observer, By Brad F. Tieman, September 2017

Click here to download the Executive Brief

A recent study reported that medical error is the third-leading cause of death in the United States, just ahead of respiratory illness and behind only cardiac disease and cancer. More than 200,000 American deaths each year are associated with preventable harm in hospitals. In addition to putting patients at risk, medical errors contribute to substantial avoidable costs estimated to exceed $17 billion annually in direct costs in the U.S. alone. Given that up to 70 percent of clinician decisions are influenced by laboratory test results, there is a major role for the clinical laboratory to play in reducing avoidable medical error, enhancing patient safety, and improving outcomes.

Lab error and patient safety
The ECRI Institute publishes an annual report on the Top 10 Patient Safety concerns. In the most recent report, two of the top ten, “test result reporting and follow-up,” and “patient identification errors,” are directly related to issues that can be addressed by the clinical laboratory. Patient identification errors and test result reporting are associated with the pre-analytical and post-analytical stages of clinical diagnostic testing. And while recent studies have shown... Read more >

Bringing data analytics to bear on diabetes care
CAP Today, September 2017, By Amy Carpenter Aquino

September 2017—Can data move the dial on diabetes? That’s the thinking behind Roche Diabetes Care’s new partnership with Accenture, and it’s how some labs and health care systems are already driving diabetes care to a whole new level.

“At Roche Diabetes Care, we want to create a leading open digital diabetes ecosystem,” says Yan Beynon, head of digital and health solutions. To do so, the company will use Accenture’s existing Intelligent Patient Platform to build a core data platform that gathers “vital pieces of diabetes information,” he says. The data will be categorized, analyzed, and transformed into “powerful insights to support improved therapy routines and outcomes.”

Within this ecosystem, Beynon says, blood glucose, insulin, blood pressure, and cholesterol levels, along with co-medication, physical activity, food intake, and other information, will be collected and analyzed and put into context. “Having all therapy-relevant data in one place and the smart algorithms to perform the ana­lyses will help to improve therapy adaptation and results,” he says. Read more >


CDC Releases 2017 National Diabetes Statistics Report

The National Diabetes Statistics Report is a periodic publication of the Centers for Disease Control and Prevention (CDC) that provides updated statistics about diabetes in the United States for a scientific audience. It includes information on prevalence and incidence of diabetes, prediabetes, risk factors for complications, acute and long-term complications, deaths, and costs. These data can help focus efforts to prevent and control diabetes across the United States.


Click here for a copy of the report.

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Last updated: 10/16/2017 Questions or corrections: © 2016  BACK TO TOP