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Charlotte Bismark Named
2015 Point of Care Coordinator of the Year!

The AACC Critical and Point-of-Care Testing Division Awards Committee has announced that Charlotte Bismark from Dixie Regional Medical Center, Named 2015 Point of Care Coordinator of the Year. This award is funded by Siemens and includes a cash award and funds to support attendance at the AACC Annual Meeting. The recipient, Charlotte Bismark, is from Dixie Regional Medical Center in Saint George, Utah

Charlotte graduated from Brigham Young University and immediately began working at Dixie Regional Medical Center, Intermountain Healthcare in 1983. While working in all areas of the laboratory, she became fascinated with Point of care testing and was instrumental in validating and implementing some of the first point of care tests at Dixie Regional. She became a full time Point of Care Coordinator in April 2001. More >


AACC would also like to congratulate the other CPOCT Division Award Winners!

  • Critical and Point-of-Care Testing Research Grant - Yusheng Zhu

  • Outstanding contributions to POC Testing - The Emory Point-of-Care Group

  • CPOCT Best Abstract Awards - Yang Luo

The IQCP Clock is Ticking!

As many of you know, on January 1, 2016 surveyors will survey for compliance with CLIA QC regulations or IQCP. After January 1, 2016, the lab will have IQCP or default QC regulations, and all new and existing test systems must be in compliance.


So what is IQCP and why do you have to probably deal with it, like it or not? IQCP provides a framework for customizing a quality control (QC) program for your test systems and your laboratory’s unique environment. By performing the steps in an IQCP, you will examine the potential sources of error in your pre-analytic, analytic and post analytic phases of testing, as well as establish the appropriate QC and quality practices which reduce the likelihood of errors occurring in your laboratory. After you complete this process, it is possible that you may determine that the amount of QC you have been doing all along is sufficient to achieve CLIA compliance.

However, you could discover potential sources of error that you had not previously considered, and may need to implement additional QC activities. In either case you will have created a comprehensive QC program, which reflects your laboratory’s unique operation, and the documentation which supports the rationale for your QC practices to ensure high quality testing.

For more on IQCP: There is a lot of information online to help with your IQCPs. Some of the things you can do, in addition to the website, andcontacting your POC device vendor, include:


Rising incidences of infectious disease and chronic conditions spell gold mine for the global point-of-care market

While tea leaves suggest another slow year for the American economy in 2015, the global point-of-care market is another story altogether. According to Ryan Schmidt, vice president of infectious disease marketing at Alere, projections of the global POC diagnostics market over the forecast period of 2013 to 2018 say it’s poised to grow at a CAGR of 9.3% percent from 2013 to 2018, to reach $27.5 billion by 2018. Schmidt said North America holds the largest market share, but Asia and Latin America should also experience high growth. “This large share is primarily attributed to the huge and increasing addressable patient population base. Moreover, the development of accurate and rapid testing kits is further fueling the growth of the POC diagnostics market in North America,” he noted. Specifically, the global POC diagnostics market is categorized into several segments, such as infectious diseases testing kits, glucose monitoring kits, coagulation monitoring kits, urinalysis testing. Read more - note, this article begins on page 27 >
Performance of Cleared Blood Glucose Monitors
David C. Klonoff, MD, FACP, FRCP (Edin), Fellow AIMBE1, and Priya Prahalad, MD, PhD, Journal of Diabetes Science and Technology, June 2015

Cleared blood glucose monitor (BGM) systems do not always perform as accurately for users as they did to become cleared. We performed a literature review of recent publications between 2010 and 2014 that present data about the frequency of inaccurate performance using ISO 15197 2003 and ISO 15197 2013 as target standards. We performed an additional literature review of publications that present data about the clinical and economic risks of inaccurate BGMs for making treatment decisions or calibrating continuous glucose monitors (CGMs). More >

Pressing Questions in POC Glucose Testing

CAP Today, April 2015, By Kevin B. O’Reilly

Sometimes major changes to a health care organization’s point-of-care testing system come from powerful regulatory agencies in Washington, DC. Or they may arise when a child with diabetes objects to frequent venipuncture. In either kind of case, experts say, pathologists and laboratory professionals must form strong relationships with clinicians and build structural foundations to help them meet these and other demands.

“If you intend to make claims for use of your meter in populations that are particularly vulnerable to potential interferences, you should include patients in surgical and medical intensive care units,” the guidance said. “To collect performance data in such populations, each study should include at least 50 patient samples from the surgical ICU and 50 patient samples from the medical ICU.”

The draft guidance, available at, has drawn dozens of comments—mostly negative—from physician organizations and other stakeholders concerned about its potential impact. Among those objecting is the CAP.

The FDA has not yet taken action to finalize or otherwise alter its draft guidance. Read more >

Glucose Meters in Critically Ill Patients: What New Guidance Means for Labs
Clinical Laboratory News, By James Nichols, May 2015

What is all the buzz about use of glucose meters in critically ill patients? Glucose meters have been used for more than 30 years to provide rapid measurement of glucose on whole blood fingersticks from patients with diabetes. Originally developed for patient self-testing, glucose meter use has expanded throughout the healthcare industry. Meters currently are being used in physician offices, schools, nursing homes, ambulances, helicopters, airplanes, and cruise ships. Glucose meters have even traveled on the Space Shuttle! They are common throughout hospitals and are used for a variety of reasons, from quick checks of glucose levels to hourly glucose level monitoring as part of intensive insulin protocols.

So, why is there now a concern over the use of glucose meters? Problems with glucose meters have been known from the start. Glucose meters designed for patient self-monitoring are validated primarily on ambulant, well patients who happen to have diabetes. These meters are calibrated for normal hematocrits and physiology.


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Last updated: 07/01/2015 Questions or corrections: © 2015  BACK TO TOP