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CLSI Releases Standards on


CLSI recently released new and revised standards on point-of-care testing in relation to glucose measuring and monitoring. Effects of Different Sample Types on Glucose Measurements,

1st Edition (POCT06-Ed1), provides information to assist the clinical and point-of-care staff in result and measurement procedure comparisons of glucose tests. More >


Glucose Control in Critical Care
Jeremy Clain, Kannan Ramar, Salim R Surani, World Journal of Diabetes

Glycemic control among critically-ill patients has been a topic of considerable attention for the past 15 years. An initial focus on the potentially deleterious effects of hyperglycemia led to a series of investigations regarding intensive insulin therapy strategies that targeted tight glycemic control. As knowledge accumulated, the pursuit of tight glycemic control among critically-ill patients came to be seen as counterproductive, and moderate glycemic control came to dominate as the standard practice in intensive care units. In recent years, there has been increased focus on the importance of hypoglycemic episodes, glycemic variability, and premorbid diabetic status as factors that contribute to outcomes among critically-ill patients. More >

Hyperglycemia in Critically Ill Patients
Amina Godinjak, Amer Iglica, Azra Burekovic, Selma Jusufovic, Anes Ajanovic, Ira Tancica,
Adis Kukuljac, Med Arh. 2015 Jun; 69(3): 157-160

Hyperglycemia is a common complication of critical illness. It was originally considered to be part of the adaptive stress-response which is beneficial for survival. However, over the past two decades, there is growing evidence that hyperglycemia is associated with increased mortality and morbidity. More >

More on glucose and critically ill patients...

IQCP is Coming - Are You Ready!

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, and contacting your POC device vendor, include:

IQCP Worries?

Help with What

Ends & Begins
CAP Today, July 2015, By Anne Paxton

Technically, it’s true: The Centers for Medicare and Medicaid Services’ new program, the Individualized Quality Control Plan, is a voluntary, alternative option that clinical laboratories can use to customize their QC plans according to test method, patient population, environment, and personnel competency.

Every lab accredited by the CAP has the expertise to do a risk assessment, Dr. Gerald Hoeltge says. “But now that risk assessment will have a structure and a table behind it.”

For much of the laboratory community, however, “optional” is the last word association they would make with “IQCP.” What many see is an entirely new quality control framework to grapple with every day; a looming cutoff date when the old, reliable system will become extinct; and potentially a major drain on their workday time and energy to cope with unfamiliar concepts of risk assessment.

Read the entire article...

IQCP: A New Option

for Quality Control

By Andy Quintenz, Medical Laboratory Observer,

mlo-online, August 2015

As January 1, 2016, draws near, clinical laboratories are gearing up for the implementation of the CLIA Individualized Quality Control Plan—IQCP. The Centers for Medicare and Medicaid Services (CMS) has been providing training, information and guidance since the IQCP trial period began on January 1, 2014.

Why is Next New Year’s Day

So Significant? As of the implementation date, the IQCP will be written into the CLIA Interpretive Guidelines for Laboratories to replace Equivalent Quality Control (EQC) procedures currently described. Between now and then, laboratories may:

  • Follow CLIA Quality Assurance (QA) requirements as written;

  • Continue to use the current EQC procedures; or

  • Implement IQCP.

After implementation, the second option will no longer be acceptable. If it is still in use, it will result in a citation for noncompliance.

Click here for more...

Understanding What IQCP Means for Your Laboratory Webinar

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.


Read more >

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Last updated: 08/28/2015 Questions or corrections: © 2015  BACK TO TOP