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2014 Awards

POCC of the Year

Najwa Adlan, from King Faisal Hospital in Saudi Arabia More >

Lifetime Achievement

Peggy Mann, from UTMB Galveston, TX

More >

Outstanding Contributions

Dr. Martha Lyon, Royal University Hospital in Saskatoon  More >


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2014

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POCT NEWS




Flu View - Upcoming Season Tests & Predictions  Ann Griswold, PhD, CAP Today

Whether exotic influenza viruses will surface this winter remains to be seen, but one thing is clear: The coming season will pack a punch in terms of promising diagnostics and forecasting models. Alere, Nanosphere, Cepheid, and Roche have new molecular tests for influenza that aim to transform the diagnostic landscape. And researchers are harnessing the power of big data to build stronger municipal- and national-level models of flu transmission that can potentially provide laboratories, hospitals, schools, and health officials with weeks of valuable prep time. Against that backdrop of innovation, the Centers for Disease Control and Prevention anticipates that the nation may see a departure from the influenza A 2009 H1N1 virus that has prevailed in recent years.
 
“It’s too early to tell, but just based on how homogeneous last season was with H1, it’s likely that we might have a B or an H3 season,” says Daniel B. Jernigan, MD, MPH, deputy director of the CDC’s Influenza Division in the National Center for Immunization and Respiratory Diseases. Click here for more...

Treating Patients with Ebola Virus Infection

in the U.S.: Lessons Learned
IDWeek, October 2014, Bruce Ribner, MD, MPH, Emory Univ. Hosp., Atlanta, GA

At the recently held IDWeek, Dr. Bruce Ribner spoke on caring for Ebola patients in the US. Dr. Ribner led the team at Emory University that cared for two patients with Ebola virus disease (EVD) in August. In light of the recent Ebola cases in Dallas and Spain he agreed that a summary could be provided to assist ID specialists in their ongoing preparedness efforts.

 

Planning for the care of patients This involves the entire institution, and needs many sections to coordinate their work. EMS services were an important coordination point for the transport of the 2 patients to Emory. On the medical staff, many types of expertise were needed for clinical management: ID, critical care, anesthesiology and several other subspecialties. Nursing, environmental management, facilities, security and media relations were all intensively involved ahead of time so that expected roles were defined. Even so, there were times when questions arose after the patients arrived.

For a summary of this talk, click here. For basic information about Ebola, click here or on the image to the right. For more details on Ebola click here to visit the CDC website or many of the other healthcare sites with articles on the Ebola situation.

The FDA Is Not Giving Up on Regulating Laboratory-Developed Tests 
Agency Plans a Decade-Long Road to Implementation
By Bill Malone, Clinical Laboratory News, November 2014, An AACC Publication
 
After the Food and Drug Administration (FDA) announced in 2010 its intention to regulate laboratory-developed tests (LDTs), lab advocacy groups, biotech companies, and even Congress pushed back so hard that by 2013, FDA leaders described their efforts as mired in politics and, at best, uncertain. Now, with a surprise announcement in July that FDA will proceed with plans to regulate LDTs followed by a draft guidance published October 3, a newly confident and determined FDA has hit the ground running.

 

According to FDA, its plan will give labs plenty of time to accommodate stepped-up oversight. During a September 10 AACC webinar, FDA Director of In Vitro Diagnostics Alberto Gutierrez, PhD, laid out a 9-year timeframe to implement LDT regulation. But the clock doesn’t even start on that timeline until after FDA issues a final guidance, a process that could take years. Based on FDA’s history with LDTs, the one thing certain is that the initial plan will not look exactly like the final plan—and it will probably take even longer to implement than the agency would like. Click here for more...

In Lab QC,

How Much Room for Improvement?
Anne Paxton, CAP Today

The debut of the CMS’ new quality control option, IQCP, has sharpened the focus on QC in the laboratory and raised hopes that risk management concepts can make QC more robust. But one of the most highly regarded quality control experts in the U.S. voices skepticism about the impact of IQCP—and indeed, about U.S. quality control standards in general.
 
As a voluntary, customizable QC option under CLIA, IQCP or Individualized Quality Control Plan is expected to give labs greater flexibility in achieving QC compliance. However, the CLIA QC standards, unchanged since 2003, will remain the same—and that’s a problem, says James Westgard, PhD, who spoke about QC weaknesses at the 2013 Lab Quality Confab presented by The Dark Report.

To read an interview with James Westgard, PhD, click here...

Key Steps for POCT in Physician Offices
Edwina Szelag, MHM, BSMT (ASCP)

You’ve been asked to take a look at a physician’s office practice after a recent merger. Do physician office laboratories (POL) need to follow the same CLIA standards as traditional clinical laboratories and point-of-care testing programs?

Answer: All clinical laboratory testing is subject to CLIA regulations, and the type of CLIA certificate for the POL should be considered along with the test menu to be offered, devices that will be used, and staff performing testing. There are several CLIA certificates. For example, if the POL will be performing only waived testing, then a CLIA Certificate of Waiver is appropriate. If the POL will be performing wet mounts, fern tests, and other microscopy, the Certificate of Provider Performed Microscopy Procedures is needed.

 

For more Q & A's on this subject, click here.

FDA Clears Nova StatStrip for

Use in Hospital CCUs

 

The Nova StatStrip Meter is the first FDA clearance of a device specifically indicated for use in all types of hospital patients, including critically ill patients.

The U.S. Food and Drug Administration cleared a new indication for the Nova StatStrip Glucose Hospital Meter System, extending its use to critically ill patients who have been hospitalized. This is the first blood glucose monitoring system (BGMS) cleared by FDA for use in these patients.

Blood glucose monitoring systems, also called blood glucose meters, are handheld devices that measure the amount of sugar (glucose) in blood by analyzing a small drop of blood that is placed on a test strip. After inserting the test strip into the device, the system displays a glucose level reading. 

 

Blood glucose measurements are used in the management of many patients in the hospital, including patients requiring insulin to manage blood sugar, and in the assessment of blood glucose levels in newborn babies.

 

More on the FDA website

 

Read the Nova Press Release

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Last updated: 11/19/2014 Questions or corrections: editor@pointofcare.net. © 2014  BACK TO TOP