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FDA Clears New Laboratory Blood Glucose Reference Analyzer from Nova Biomedical

The U.S. Food and Drug Administration (FDA) has cleared Nova Primary as a blood glucose reference analyzer. Nova Primary fills the need for a new glucose reference analyzer to replace the discontinued YSI STAT PLUS 2300 Glucose and L-Lactate analyzer (YSI, Inc., Yellow Springs, OH).

Manufacturers of blood glucose measuring devices and clinical diabetes researchers have relied on the YSI 2300 as a reference and correlation analyzer. However, YSI, Inc. no longer supports the analyzer, and its discontinuation has left a critical industry void. The Nova Primary analyzer fills that need. With this FDA clearance, Nova Primary is now available in the U.S. and worldwide.

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POC News

Vendor Update
The LumiraDx Platform has on the market, and in development, 30+ tests covering infectious diseases, cardiovascular disease, diabetes and coagulation disorders.
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Virtual Webinar

November 15, 2022
11:00 AM – 1:00 PM ET 7:00 PM – 9:00 PM ET

Optimizing Patient Safety through Comprehensive Bleeding Management in Cardiac Surgery

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Documenting Critical Values at the Point of Care

CLN Bench Matters: September 2022, Author: Brad S. Karon, MD, PhD, FCAP

A critical value is a laboratory value that, if not acted upon promptly, may result in patient harm. Different healthcare regulatory and accrediting organizations have developed different definitions and requirements related to critical values. Common elements include: A definition of which tests and values are defined as critical values (generally low or high abnormal results or positive qualitative results); An organized system, described in one or more policies and procedures, on how a responsible party or caregiver is notified of a critical laboratory result. The system will define which responsible parties may accept critical results; A policy and procedure on how critical results are communicated, including the steps needed to document critical value notification; An acceptable time limit for communication of critical results.

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Connectivity and data management are vital for point-of-care testing

MLO | July/August 2022 by Steven Valorz, Carol Wise MT(ASCP), Zach Fortuna, MLS, CPP, Karen Carver, MT

As the demand for point-of-care testing (POCT) continues to grow and the testing becomes more complex, it is more important than ever to be able to track and monitor all aspects of a POCT program and get all test results into the patient record in a timely manner. The pandemic made it clear that POCT is crucial and can take place just about anywhere — retail locations, campus parking lots, physician office labs, clinics, and mobile vans. Along with expanding locations, POCT has moved far beyond just glucose and urine dipsticks.

We are now seeing devices that are usually considered ‘main lab’ moving out to these decentralized locations. No matter the location of the testing, the responsibility for the management of the testing, most often, still falls on laboratory personnel. Device connectivity and a robust data manager are imperative for a successful program by providing testing that is safe for patients and helping meet accreditation requirements.

Read more online > | Read from the MLO's digital version >

Jeanne Mumford, MT(ASCP) 2022 recipient of the
Point of Care Coordinator of the Year Award

The AACC CPOCT Division annually recognizes excellence demonstrated in POCT by a POC Professional. For 2022, the Division Awards Committee has recognized Jeanne Mumford, MT(ASCP) as the recipient of the Point of Care Coordinator of the Year Award!
Jeanne is a Pathology Manager for POCT for Johns Hopkins Medicine and is the President of the Keystone Point-of-Care Coordinators (KEYPOCC) in Pennsylvania. Her bio will be posted on the Division Awards page soon.

Jeanne will receive her award at the AACC Annual Meeting during CPOCT Division Membership Meeting, Tuesday, July 26th @ 6pm in the Water Tower Room at the Marriott Marquis Chicago.


RALS User Groups Going Back on the Road!

Face-to-face meetings are back! It's been more than 2 years since the last face-to-face RALS User Group (RUG) was held and the time has arrived to go back on the road again with all-new learning sessions! At these sessions, RALS users can meet with their colleagues for networking opportunities - Get to meet and develop relationships with your RALS peers, learn what's new and what's coming in RALS, enjoy full-day, SME led, complimentary sessions by RALS Subject Matter Experts (SMEs). In addtion, up to CEUs -  3.0 Continuing Education Units are available.

For dates and locations, click here >

The Importance of Accurate Glucose Monitoring in Critically ill Patients

Medical Laboratory Observer, March 2022, Dennis Begos, MD

What makes a patient “critically ill”? The term gets used often, but it can be difficult to define.

Certainly, being in an intensive care unit (ICU) should satisfy this, but, paradoxically, not every patient in the ICU is critically ill, and patients outside of the ICU setting have the potential to be considered critically ill. Very sick patients are often not in intensive care units, but throughout the hospital: emergency departments, post-anesthesia care units, operating rooms, and labor and delivery. These patients require specialized, timely, and individualized care to achieve the best outcomes.

To say that only patients residing in the ICU require this stepped-up level of care is to potentially underestimate their disease severity and overlook factors which may adversely affect outcomes. One such factor is glycemic control.

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Lab of the Year

Medical Laboratory Observer, March 2022

Mary Greeley Medical Center Laboratory

Medical Laboratory Observer (MLO) named Mary Greeley Medical Center Laboratory Lab of the Year (LOY) for 2022. Mary Greeley Medical Center Laboratory excelled in the criteria MLO staff and its editorial advisory board judged the nominees on, which are customer service, productivity, teamwork, education and training, strategic outlook, and lab inspections.

Located in Ames, IA, Mary Greeley Medical Center is a 220-bed regional hospital that serves people in a 13-county area in Central Iowa.

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Lab of the Year - Runner Up

Cincinnati Children’s Hospital Medical Center Clinical Laboratory

Cincinnati Children’s Hospital Medical Center (CCHMC) is one of the oldest and most distinguished pediatric hospitals in the United States, established in 1883. The academic pediatric acute care hospital has 634 beds.

Cincinnati Children’s clinical laboratories’ customer service efforts strive to improve child health, transform delivery of care, and achieve the best medical outcomes, experience, and value for patients.

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Validation of Point of Care Blood Glucose Monitoring Systems in Hospital Settings

CLN JanFeb 2022 | Author: Nam K. Tran, PhD, HLCD (ABB), FAACC

Although point-of-care (POC) glucose monitoring has transformed hospital-based glycemic control programs, the use of POC glucose monitoring in critically ill populations has garnered much attention because research shows that some POC glucose meters are unsuitable for the hospital population.

Several investigations have highlighted the role of interfering substances causing inaccurate POC glucose meter measurements. Many of these interferences, such as anemia, presence of oxidizing/reducing substances, and high pO2 levels, are commonly observed in hospitalized populations,

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