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What's Happening in POCT


POCT NEWS

A Message from the AACC Critical and Point of Care Testing Chairperson...

 

By way of introduction, my name is Kerstin Halverson and as of January 1, 2018, I am the Chair of the CPOCT Division. We are coming off an exciting year and are planning a number of outstanding events for 2018, including programs at the AACC Annual Meeting like the POC Forum and of course AfterGlow!  Read more >


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Flu Map Shows How the Biggest Influenza Outbreak in Years Spread Across the U.S.
TIME Health, By JAMIE DUCHARME and DAVID JOHNSON January 19, 2018

With months left to go in the 2018 flu season, the U.S. has already hit an unfortunate benchmark, as shown on the flu map below: For the first time in the Centers for Disease Control and Prevention’s 13 years of influenza monitoring, every state in the continental U.S. is seeing “widespread” virus activity.

The U.S. is experiencing such an active flu season that the CDC held a special briefing on the topic last week, explaining that there’s an uptick in both confirmed cases of the disease and hospitalizations related to it this year. The flu is so widespread, in fact, that the agency has declared it an epidemic, and urged those who have not been vaccinated to seek out the flu shot. But how did this year’s flu season get so bad? Read more >

Blood Glucose Test Strips
Another Shared Diabetic Supply Harboring Bacterial Contamination
Clinical Laboratory News, By Sharon Geaghan, MD, January 2018

When you or a family member are admitted to the hospital, you expect that the room will be cleaned and disinfected thoroughly. You do not expect to find half-used tissue paper boxes or leftover bandages from the previous patient. To the contrary, patients expect that hospitals will take all necessary precautions to avoid spreading disease, including disposing of patients’ medications when they are discharged from a facility.

Perhaps the only exception to the current practice of single-use, single-patient hospital supplies is blood glucose test strips. Hospitals and other institutions often procure blood glucose test strips in 25- or 50-count vials and bring them from patient to patient and room to room for testing purposes. Testing sites range from acute care hospitals, outpatient clinics, skilled nursing facilities and long term care facilities to prisons, shelters, surgery centers, schools, and camps. Read more >

Devices, Decisions: Glucose in the Critically ill
CAP Today, January 2018, by Anne Ford

 

Using point-of-care glucose meters in critically ill patients can feel like tiptoeing through a regulatory minefield. Perhaps your preferred meter hasn’t been cleared by the FDA for use in this population. Or maybe you’re not sure which assay performance requirements should be regulating the performance of your meters. Or perhaps you’re still trying to define “critically ill.”

 

Recently published studies have aimed to clear some of those mines by evaluating the accuracy of glucose meter results in ICU and non-ICU settings and by also assessing meter performance in a clinical context rather than a strictly analytical manner. Those studies, the four options labs have, and a look at the POC policy in place at Ohio State University Wexner Medical Center were spotlighted at last year’s AACC annual meeting in a session, “The Burden of Proof for Point-of-Care Glucose Monitoring in Critically Ill Patients,” presented by James H. Nichols, PhD; Alison Woodworth, PhD; and Steven Cotten, PhD.

While nursing tends to think that capillary samples are easier than phlebotomy, Dr. Nichols said, variations in operator technique mean there is ample room for error. And getting an adequate reflection of the patient’s physiology isn’t a given. What if the patient is...

Read more >

Looking Beyond HbA1c Outcomes

for Type 1 Diabetes
Leading diabetes organizations release consensus definitions for hypoglycemia, hyperglycemia, time in range, diabetic ketoacidosis.
January 4,2018; CLN Stat

A consensus report by major diabetes organizations includes standard definitions for outcomes in type 1 diabetes, including hypoglycemia, hyperglycemia, time in range, and diabetic ketoacidosis.

After doing their homework on the clinical evidence, major diabetes organizations issued a series of priority outcomes for type 1 diabetes (T1D), looking beyond the scope of hemoglobin A1c (HbA1c). HbA1c, which assesses mean blood glucose measures over a 3-month period, is an important tool in diabetes care management. However, the test is limited in that it can’t capture short-term fluctuations in blood glucose, exposure to hypoglycemia and hyperglycemia, or the impact of blood glucose variations on quality of life.

“Recent advances in type 1 diabetes technologies and research have made it feasible to assess the efficacy of therapies and technologies using a set of outcomes beyond HbA1C and to refine definitions of outcomes such as hypoglycemia. However, while definitions for hypoglycemia in clinical care exist, they are not standardized, causing inconsistency in the definitions used in different research studies,” according to a statement from the American Diabetes Association (ADA). Read more >

HbA1c Shows its Mettle Predicting Diabetes Risk
CAP Today, Anne Paxton, December 2017

The longitudinal Framingham Heart Study, which first identified the concept of risk factors and made serum LDL cholesterol a household name, could help increase the celebrity status of HbA1c, with the Oct. 26 publication of a new study in Diabetes Care.

International and national organizations since 2010 have recognized HbA1c as a valid way to diagnose abnormalities in glycemia and diabetes mellitus. But there has been less consensus on its use as a screen for elevated diabetes risk.

It has been shown that elevated HbA1c and elevated fasting glucose are better at diabetes prediction than fasting glucose alone. But is HbA1c associated with incident diabetes independently, such that HbA1c results can identify individuals with high diabetes risk? That was the question addressed in the Diabetes Care retrospective study “Prediction of type 2 diabetes by hemoglobin A1c in two community-based cohorts,” in which the authors reviewed extensive data collected on subjects of the Framingham Heart Study and the Atherosclerosis Risk in Communities (ARIC) study (Leong A, et al. doi.org/10.2337/dc17-0607).

Based on that data... Read more >

Role of Medical Devices in the Data Management Processes of the Modern Clinical Laboratory
By Shawn Hall, MLO, November 2017

As the modern clinical laboratory becomes more connected, it becomes increasingly difficult to efficiently exchange and manage data. This is especially true with regard to interoperability, where data is exchanged among several clinical systems. Yet diagnostic laboratories have become such an integral part of the connected healthcare paradigm that methods for expanding their scalability, improving performance, and managing data are critical to achieving the core objectives of meeting the needs of clinicians and patients.

Laboratories have long stressed efficiency, safety, and quality in the management of diagnostic data; however, the focus has primarily been on the analytical phase. But the trends toward lab automation and increasing testing require that laboratories constantly adapt to ever-changing data management requirements in all phases of the testing process. This article addresses pre- and post-analytical data management processes; discusses challenges such as patient safety, complex workflows, and reporting responsibilities; and examines how data management features of analytical medical devices can have a positive impact in today’s connected clinical laboratory. Read more >

Point-of-Care Tests Help Manage Influenza
CLP, By Patrick Murray, PhD, November 2017
 

This year’s flu season requires clinical labs to take into account a variety of new considerations, including FDA reclassification of RIDTs.

Vaccines are the best defense against influenza, but predicting when influenza will occur and which strains will appear is a challenge (see Figure 1). In 2009, a novel strain of influenza A arose during the summer, and continued with significant disease into the fall.1 In 2013, a new strain, H3N2, made its debut and was responsible for the majority of disease that year.1 This strain has been the predominant virus in seasonal outbreaks for the past 3 years. Despite the fact that this strain is covered under current vaccines and was once again responsible for the majority of influenza cases during the 2016–2017 flu season, however, the prevalence of the strain led to particularly severe outcomes for children and older adults. Read more >

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