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Glucose Meters: Current Regulatory Guidance for Manufacturers and Providers
April 2019, MLO, By Jeffrey A. DuBois

Therapeutic management of blood glucose in patients with diabetes in the home or in the hospital involves the use of glucose meters for the rapid assessment of whole blood glucose. On Oct. 11, 2016, the U.S. Food and Drug Administration (FDA) published guidance documents for glucose meters. These guidance documents are for manufacturers, not for providers. The Centers for Medicare and Medicaid Services (CMS) and its designees provide accreditation (certification) for and oversight of provider compliance under the Clinical Laboratory Improvement Amendments (CLIA) of 1988. This is an important distinction for all stakeholders involved in the management of dysglycemia in hospitalized patients, many of who are on intensive insulin therapy to achieve safe and effective glycemic control.

The FDA guidance documents make a clear distinction between devices that are designed, cleared, and classified for self-monitoring of blood glucose in the home and devices that are designed, cleared, and classified for blood glucose monitoring for prescription point-of-care (POC) use. It took six years for the FDA to publish these guidance documents for manufacturers. Read more >

MLO Selects 2019 Lab of the Year!
Penn Medicine Lancaster General Health

Selecting a Lab of the Year is never an easy task thanks to the outstanding nominations MLO receives year after year. And since history tends to repeat itself, 2019 was no different. With much respect and admiration, MLO is proud to present the 2019 LOY winner: Penn Medicine Lancaster General Health Laboratory!

Located in Southern Pennsylvania, approximately 70 miles west of Philadelphia, sits Lancaster General Health Laboratory, part of Lancaster General Hospital (LGH). This 533-bed, nonprofit hospital is part of Lancaster General Health/Penn Medicine, a member of the University of Pennsylvania Health System (Penn Medicine). Read more >

Critical Points - AACC Critical and POCT News

The latest edition of the CPOCT Division Newsletter has been posted to the CPOCT Division webpage. Please navigate to the Division webpage within, or copy and paste this link below to take you directly

Highlights include: Division Awards Nominations and upcoming 2019 CPOCT division activities not to be missed!

POC Roundtable: Risks, Resources, Relationships
CAP Today, March 2019

Infection control and the heavy demands on point-of-care coordinators were among the top concerns that came up in a recent CAP TODAY roundtable on point-of-care glucose testing.

CAP Publisher Bob McGonnagle spoke with four POC testing experts: Sharon Geaghan, MD, Cynthia Bowman, MD, Steven Cotten, PhD, and Corinne Fantz, PhD. Read what they had to say...

HealthGrade's Best Hospitals for 2019
By HealthLeaders Media, February 2019

Healthgrades released its annual list Tuesday of "America's Best Hospitals," using clinical outcomes to identify the top 5% of hospitals nationwide.In years past, Healthgrades released two separate awards, one for the top 250 hospitals in clinical excellence and the other for the the top 50 and 100 hospitals. But this year is the first time the two awards have been consolidated into a single list.

"Consumers have many options for care, so when hospitals prove their long-term commitment to the patient and to achieving high-quality clinical outcomes, it sets their system apart in a sea of choices," Healthgrades Chief Medical Officer Brad Bowman said.

To see the top 50 hospitals for 2019, as identified by Healthgrades and grouped by state,
click here >

Complimentary Training Support for
Urinalysis and Diabetes

Siemens Healthineers is pleased to announce the availability of complimentary training support tools
for our point-of-care chronic disease management portfolio. Listed below are the resources available
to you. These online options provide you with easy access to in-service product training, forms, and procedures for your staff.

For the CLINITEK Advantus® Urine Chemistry Analyzer, CLINITEK Status® family of analyzers,
DCA Vantage® Analyzer and Xprecia Stride™ Coagulation Analyzer, we offer the following:

Sign up for Remote Video Training: Receive telephone or video training from a medical technologist. To schedule your complimentary training session, email or call 1 (866) 748-7463 to speak with a training specialist.

Individualized, Competency-based Education: Click here to register for personalized product training modules and assessment tools.

In-service Training tools: Click here to conduct in-house training events for your staff and access product-specific training and support documents to maintain your audit-readiness.

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


Last updated: 11/09/2018 Questions or corrections: 2016  BACK TO TOP