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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 >

PRIDE Statement on the Need for a Moratorium on the CMS Plan to Cite Hospitals...

...for Performing Point-of-Care Capillary Blood Glucose Monitoring on Critically Ill Patients
David C. Klonoff, Boris Draznin, Andjela Drincic, Kathleen Dungan, Roma Gianchandani, Silvio E. Inzucchi, James H. Nichols, Mark J. Rice, and Jane Jeffrie Seley, J Clin Endocrinol Metab

A writing committee of the Planning Research in Inpatient Diabetes (PRIDE) group has
written this consensus article on behalf of the group in response to a specific request for input from the Centers for Medicare and Medicaid Services (CMS).


The purpose of this article is to respond to the March 13, 2015 statement from that agency regarding plans to enforce prohibition of the off-label use of point of care (POC) capillary blood glucose monitor (BGM) testing in most critically ill patients. The article discusses:

  1. How POC BGM testing is currently regulated;

  2. How POC BGM testing is currently used in the United States; and

  3. How POC BGM testing can be safely and effectively regulated in the future through cooperation between the clinician, laboratory, regulatory, industry, and patient communities.

Descriptions of current medical practice for critically ill patients were derived from the experience of the authors. Descriptions of the performance of various methods for measuring glucose levels for intensive insulin therapy came from a literature review.

The Consensus Process included eleven questions developed by the PRIDE writing group. After extensive electronic and telephone discussion, the article was written and reviewed by all nine authors and then reviewed by two outside experts in the care of critically ill patients. All suggestions by the authors and the outside experts were incorporated. More >

Updated October 5, 2015

Full-court Collaboration in Transition to IQCP
By Anne Paxton, CAP Today, September 2015

With the CLIA Individualized Quality Control Plan process geared to unseat the familiar Equivalent Quality Control process on Jan. 1, there seems to be wide agreement that microbiology laboratories will have the biggest adjustment to make to comply with CLIA QC requirements, despite the IQCP being voluntary.

“IQCP will have a more profound effect on clinical microbiology than some other areas of the lab that already run positive and negative controls every day they run tests,” says Susan Sharp, PhD, president-elect of the American Society for Microbiology and a member of the CAP Microbiology Resource Committee.

Janet A. Hindler, MT(ASCP), also a committee member and a senior specialist in clinical microbiology at UCLA Medical Center, says, “We will either be preparing IQCPs or we will revert to following CLIA regulations developed in ’88, despite the fact that for several commonly employed clinical microbiology tests, CMS recognized several decades ago that there were less stringent alternatives for QC of these tests.”   More >

Decentralized Coagulation:

The role of POCT in the diagnosis of clotting disorders
By Michael Jones, Advance for Administrators of the Lab, Vol. 24 • Issue 9

When it comes to a blood clot, every second matters. Clotting conditions like deep vein thrombosis (DVT) or venous thromboembolic (VTE) disorders pose significant concerns as morbidity and mortality from complications like a stroke or pulmonary embolism are a very real threat. Clinicians and physicians must be able to determine the clotting factors in a patient's blood with speed and accuracy. In a recent interview with ADVANCE, American Society of Hematology (ASH) spokesperson Roy Silverstein, MD, professor and chairman of medicine at the Medical College of Wisconsin, senior investigator at the Blood Research Institute at the Blood Center of Wisconsin, discussed the benefits and limitations of point-of-care testing (POCT) in the diagnosis of coagulation disorders.

"In general, point-of-care testing has gotten a whole lot better now than it was 10 years ago, but still, it suffers by comparison to the laboratory-based test in terms of the accuracy and precision," said Silverstein. More >

Measuring Point-of-Care Blood Glucose in Critically Ill Patients
Nursing Critical Care, July 2015, Corl, Dawn E. MN, RN, CDE, CDTC

Critically ill patients require frequent, accurate blood glucose (BG) monitoring. BG measurement devices and sample types have significant differences related to cost, convenience, turnaround time, and accuracy. More stringent standards have been drafted for hospital point-of-care (POC) devices. Safety considerations include: blood-borne pathogen contamination, sample-related errors, interferences, and patient conditions.

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 >

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