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Point-of-Care or Clinical Lab INR for Anticoagulation Monitoring: Which to Believe?
By Stacy A. Johnson, MD, Clinical Laboratory News, April 2017

68-year-old female with a history of hypertension, diabetes mellitus, stroke, and atrial fibrillation presents for routine follow-up at your hospital’s anticoagulation clinic. The clinical pharmacist checks her international normalized ratio (INR) with a point-of-care (POC) device to monitor her anticoagulant therapy (warfarin).

The POC INR result is elevated to 4.0, which is above the recommended INR goal range of 2.0–3.0 based on her clinical indication of atrial fibrillation. The pharmacist enters the POC INR result into the patient’s electronic medical record and discovers she had an INR obtained earlier that same day, along with a basic metabolic panel and complete blood count ordered by her primary care physician. The clinical lab (CL) INR result was 2.9, and obtained just 90 minutes earlier. All other test results were normal.

The patient says...... Read more >

Bedside Blood Glucose Testing

in Critically Ill Patients
By T. Scott Isbell, MLO, April 2017

This month's issue of MLO has a really good, continuing education, article on how studies have demonstrated that the practice of hospital bedside blood glucose testing is a necessary and effective means of managing and monitoring glycemic control. Protocols vary by institution, but there is general consensus among providers that this process is an essential component of patient care. However, the use of handheld blood glucose meters within some critically ill patient populations has resulted in varying degrees of confusion about off-label use and potential discrepancies in results.


  1. Define what constitutes a critically ill patient population and discuss the use of handheld blood glucose monitors in critically ill populations.

  2. Discuss agencies that regulate off-label device use and identify the guidelines that laboratories must adhere to, in order to be compliant with off-label device use.

  3. Recognize the characteristics of diabetes statistics as the relate to healthcare and morbidity.

  4. List testing methods for diagnosing and monitoring diabetes and define the limitations with each method.

Read more >

For more on diabetes/glucose testing, check out the April MLO Digital Edition.

Management of Inpatient Hyperglycemia

and Diabetes in Older Adults

Diabetes Care 2017;40:509–517 | DOI: 10.2337/dc16-0989


Adults aged 65 years and older are the fastest growing segment of the U.S. population, and their number is expected to double to 89 million between 2010 and 2050. The prevalence of diabetes in hospitalized adults aged 65–75 years and over 80 years of age has been estimated to be 20% and 40%, respectively. Similar to general populations, the presence of hyperglycemia and diabetes in elderly patients is associated with increased risk of hospital complications, longer length of stay, and increased mortality compared with subjects with normoglycemia. Clinical guidelines recommend target blood glucose between 140 and 180 mg/dL (7.8 and 10 mmol/L) for most patients in the intensive care unit (ICU). A similar blood glucose target is recommended for patients in non- ICU settings; however... Read more


Hospitalized patients with uncontrolled hyperglycemia are at increased risk for a variety of adverse outcomes, including prolonged hospital stay, infectious complications, and death. In the United States, one in four adult hospitalized inpatients has a known diagnosis of diabetes, and another 12% have hyperglycemia without a preexisting diagnosis. Hypoglycemia is also an important inpatient problem. Insulin is one of the most common sources of inpatient adverse drug events, and more than half of these events are preventable. Professional societies and standards organizations, on the basis of consensus and local experience, have highlighted the importance of optimizing inpatient glycemic control and reducing hypoglycemia. Systematic reviews or metaanalyses regarding large-scale efforts to improve inpatient glycemic control and reduce hypoglycemia could not be located in the literature.

In late 2011 Dignity Health (San Francisco), the largest hospital provider in California, set out to significantly improve hypoglycemia, uncontrolled hyperglycemia, and glycemic control across a diverse group of 9 hospitals within its 39- hospital system in three states.

PDF | TJC Journal Online

HbA1c in CVD Treatment:

Farewell to One Size Fits All
By Anne Paxton, CAP Today, March 2017

Anchor. Central pillar. Cornerstone. It would be hard to find a weighty synonym for “linchpin” that hasn’t been used to describe HbA1c’s role in diabetes diagnosis and management since 2010, when the assay was recognized by key standard-setting organizations as the equal of fasting glucose and oral glucose tolerance testing in diabetes and prediabetes testing.

But recognition of the complex nature of the relationship between HbA1c and diabetes-related complications has influenced and modified HbA1c’s clinical use as the test evolves. A new review article by experts in the field outlines how use of the HbA1c test in cardiovascular disease treatment and prevention is trending toward a more patient-centered approach as the assay’s intricacies are explored. Read more >

Diabetes Decision Time: Proficiency testing hurdle slows use of POC HbA1c tests
By: Deborah Levenson, March 2017, Clinical Laboratory News

More than 29 million Americans—about 9% of the U.S. population—have diabetes, according to the American Diabetes Association (ADA). Racial and ethnic minority groups have higher rates of the disease, which, when not managed effectively, leads to debilitating complications like cardiovascular disease, kidney disease, stroke, and blindness. As it is, however, some patients are well down the road to developing these sequelae before being diagnosed formally with diabetes. Since point-of-care (POC) tests that measure HbA1c are well-established tools for monitoring and managing long-term glycemic control, some healthcare professionals believe using them for diagnosis would catch individuals earlier in the diabetes disease process, enabling timelier treatments and better outcomes. More >

Advances in POCT technologies outpace regulatory and accreditation requirements
Jeffrey A. DuBois, MLO, February 2017

Long after their deaths, two famous scientists continue to challenge us with their words. “Knowing is not enough; we must apply. Being willing is not enough; we must do,” said Leonardo da Vinci, Italian artist, scientist, and inventor. “The true sign of intelligence is not knowledge but imagination,” spoke German-born theoretical physicist Albert Einstein. Their pioneering work has influenced all areas of science and, perhaps, even science fiction.

The imaginary tricorder in the Star Trek series may represent the ultimate goal of integrated point-of-care diagnostics, but it remains a fictional object. However, the Internet of individual care (and with it, the creation of high volumes of clinical data), where sensors, tests, and wearable devices have moved out of the laboratory and clinic directly into our lives for self-management and remote monitoring, has already begun and presents significant challenges to providers, regulators, and accreditation agencies alike. More >

IQCP: The Critical First-Year Findings
By Irwin Rothenberg, MBA, MS, MLS(ASCP), Advance for Administrators of the Lab, February 2017

A year ago, laboratory journals, professional meetings and in-house planning were all about the pending deadline for implementation of the new CMS quality control option, the Individualized Quality Control Plan (IQCP), which was replacing the Equivalent Quality Control (EQC) testing already in place.


With the January 1, 2017 implementation date rapidly approaching, many laboratorians had already begun performing their risk assessments, and making revisions to their existing QC Plans (as needed). Laboratory quality assessment schedules were revised to include QAs for the new IQCPs.

Whether or not IQCP is judged effective at actually improving the quality of the testing performed depends on how well the implementation process is carried out, along with the subsequent quality assessments performed. More >

How did your lab do with POCT?
Patrick Murray, MLO, February 2017

The end of flu season is in view
At this point in the year, most healthcare providers are seeing a steady wave of patients with flu-like symptoms. They may be struggling to pinpoint underlying causes and identify the appropriate treatment in a timely manner. Flu and respiratory syncytial virus (RSV) have overlapping peak infection seasons, making it difficult to distinguish the two clinically. Group A streptococcus is also common now.

We’ve likely seen the peak of flu season, and RSV may be starting its wind-down as well, so this is a good time to begin reflecting on how point-of-care testing (POCT) in your institution affected performance in managing winter respiratory tract infections. Upon reflection, how might your POCT strategy be improved for the next flu season? Here are some considerations for lab managers, which may help with planning for 2017-2018.

Effect on overuse of antibiotics
An incorrect diagnosis or inaccurate test result may point providers to the wrong treatment, exacerbating the overuse of antibiotics. More than 25 percent of antibiotics are prescribed for conditions that don’t warrant them.3 Out of 97 million annual office visits among adults in the United States between 2007 and 2009 that resulted in an antibiotic prescription, 41 percent were for a respiratory condition, the most common out of seven categories. More >

Accriva Diagnostics Acquired by

Werfen and Instrumentation Laboratory

Accriva Diagnostics, a Warburg Pincus portfolio company, announced today the definitive agreement with Werfen, a privately held medical diagnostics firm headquartered in Barcelona, Spain, and its subsidiary Instrumentation Laboratory (IL) headquartered in Bedford, MA, whereby Werfen and IL have acquired all shares of Accriva. The transaction was successfully closed on January 19, 2017.

The Accriva portfolio, including globally recognized point-of-care (POC) diagnostic products for coagulation and anti-platelet therapy response, will allow IL to establish a market-leading position in hospital-based POC Hemostasis testing, expand its position in POC Critical Care testing and complement its leadership in the Hemostasis Laboratory segment.


Accriva Website  |  Accriva Press Release  |  Werfen/IL Press Release

Is improving access for patients equaling loss of critical quality oversight?
Advance for Adminstrators of the Lab, At the Bedside, By Peter Koerte on January 2017

Diagnostic testing traditionally performed in healthcare settings such as hospitals and reference laboratories is increasingly expanding beyond the brick-and-mortar boundaries of which we’ve grown accustomed. Today, point-of-care testing (POCT), or testing conducted outside the laboratory, is quickly evolving to help expedite patient care and clinical decision-making.

There are key benefits to the point-of-care testing approach. The first pertains to response time and its effect on patient care. Critical Stat tests can be processed more quickly, expediting patient care for emergency situations such as suspected venous thromboembolism. More >

FDA Releases Two Final Guidance Documents
on Blood Glucose Monitors
Clinical Laboratory News, December 2016

The Food and Drug Administration (FDA) has released the final versions of two guidance documents, “Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use” and “Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use.” These documents describe the studies and criteria that manufacturers should submit when seeking clearance for blood glucose monitors designed for use by healthcare professionals and patients at home, respectively. More >


The complete versions of both guidance documents are available at

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