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What's Happening in POCT


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 www.fda.gov

Laboratory Management of POCT
Thorough evaluation and stewardship by the laboratory are
necessary before and during implementation.


Thorough evaluation and stewardship by the laboratory are necessary before and during implementation.

The demand for point-of-care testing (POCT) is increasing in response to the value-shift in healthcare and advancements in technology. A number of factors are converging to promote the value of POCT (e.g., increases in infectious diseases; increases in lifestyle diseases, such as cardiac diseases and diabetes; increased patient desire to use home-based POC devices; and technological advancements creating faster and easier-to-use devices). Testing that takes place by the patient’s side offers rapid turnaround time (TAT) and the patient-focused approach that supports healthcare’s transition toward more cost-effective and patient-centered care.


The driving concept behind POCT growth is that bringing testing closer to the patient and results conveniently and quickly to the provider can speed up diagnosis and treatment.

More >


CAP to Discontinue WBG WG2

Whole Blood Glucose Surveys


The College of American Pathologists’ (CAP) Laboratory Accreditation Program (LAP) will no longer require enrollment and participation in proficiency testing (PT) for waived whole blood glucose on glucose meters (ie, WB2/WBG) and waived whole blood Protime/INR (ie, WP10) beginning with the 2017 PT program year. Laboratories will be required to perform alternative performance assessment for these analytes.


To read the letter from CAP, click here.


If you have questions regarding this change, please contact a PT Compliance representative at 1-800-323-4040 ext. 6052 or 1-847-832-7000 ext. 6052. To learn more about CAP Quality Crosscheck products, please visit the CAP online store (please note, the whole blood glucose Quality Cross Check product will not be available until the 2017 ordering information is posted) or contact CAP Customer Service at 1-800-323-4040 (Option 1).

Siemens Healthineers acquires
Conworx Technology GmbH

Siemens Healthineers announced that the company is expanding its informatics capabilities for point-of-care testing with the acquisition of Conworx Technology GmbH, the Berlin-based developer of point-of-care device interfaces and data management solutions. The addition of the Conworx suite—including UniPOC and POCcelerator—complements the Siemens Healthineers award-winning RAPIDComm Data Management System and will elevate the informatics offerings for the point-of-care market by delivering open connectivity for more than 100 different instruments from all major manufacturers. More >
Addressing Antibiotic Resistance with Molecular Diagnostics
New methods promise faster and more accurate detection of MDROs

By Elena V. Grigorenko, PhD, and Donald R. Stalons, PhD, D(ABMM), MPH, CLP, October 2016

Antibiotics are marvels of modern medicine that have helped healthcare professionals fight infections caused by bacteria for the past 70 years. However, there is concern for the current use and future benefits of antibiotics. According to the World Health Organization (WHO), widespread inappropriate use of antibiotics has created global resistance that may soon drive every nation into a post-antibiotic era. More >

Rapid point-of-care assays for influenza testing
By: Norman Moore, October 2016, MLO

The estimated overall vaccine effectiveness rate for the 2015-2016 flu vaccine was below 50 percent, underscoring the importance of accurate and timely diagnosis for improving patient outcomes and reducing the public health impact of this potentially deadly illness.

Clinical guidelines from the U.S. Centers for Disease Control and Prevention (CDC) and other expert groups recommend initiating antiviral treatment within 48 hours of onset.1 Yet many of the influenza assays widely used today do not realize the full potential of diagnosis because they do not provide highly accurate results quickly enough for clinicians to make informed treatment decisions while the patient is still under their care. More >

CMS Says Nurses Can Perform
High Complexity Tests

By Glen McDaniel, Advance Newsmagazines - www.advanceweb.com


The Centers for Medicare and Medicaid Services (CMS) recently published a memo that it sent to CLIA inspectors on how to interpret educational requirements. CLIA had always specified the minimum educational requirements for individuals performing laboratory tests.


In recent years there has been quite a strong lobby from nursing to recognize a nursing degree as a biological science degree, having the requisite credit hours of biology, chemistry etc. Those of us with oversight for point of care testing (POCT) had also been unsure as to whether nurses could perform non-waived tests and maybe even fully manage a POCT program where non-waived tests were utilized.


Now CMS has weighed in definitively by saying that, yes, a nursing degree is a science degree making nurses qualified to perform non-waived tests. A careful reading of the CLIA regulations would suggest that if that is true, then nurses may in fact be allowed to even direct laboratory testing. Read more >

AACC Launches Express Membership Category

$65 Annual Fee Provides Numerous Association Benefits

Great news for POCCs and Exclusively for New Members, AACC’s New Express Membership enables you to benefit from a wide range of resources at an affordable dues level, including:
Access to AACC’s online networking opportunities; Select educational programs, and News publications.


One of the essential ways that AACC members convene is online through the members-only AACC Artery. Discussions cover a range of topics from the challenges of monitoring point-of-care testing compliance to practical lab fundamentals, such as critical values and specimen types and retention. For more details, and to sign up, visit the Express Member page!

Click here for more stories in our Article Archives...



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Last updated: 12/07/2016 Questions or corrections: editor@pointofcare.net. © 2016  BACK TO TOP