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2014

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POCT NEWS



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 >


TELCOR’s QML®

Achieves ONC HIT 2014 Edition Modular Certification from ICSA Labs

Click here


STAT Technologies, a specialty U.S. distributor of CLIA waived point-of-care testing products and supplies, added to POC Vendor listing... click here

 

Managing Risk at the Point-of-Care:

Preventing Errors
July 2014, by Sarah Njoroge, PhD and James H. Nichols, PhD, DABCC, FACB, Clinical Laboratory News

Although point-of-care testing (POCT) provides rapid test results and the opportunity for faster medical decisions, the unique risk of errors with POCT raises concern over the quality and reliability of test results. In contrast to the central laboratory, where errors predominately occur in the pre- and post-analytic phases, POCT errors occur primarily in the analytic phase of testing. This might be related to the non-laboratory staff involved in POCT, but might also be due to test limitations and misuse of POCT in extreme environmental conditions.

Clinical personnel with minimal laboratory skills and experience, such as nurses and patient care technicians, perform the majority of POCT. These operators are focused on patient care and do not necessarily understand why they must handle POCT—a task viewed as a laboratory role and not a job for clinical staff.

Yet regulatory standards hold the laboratory director responsible for managing and supervising POCT quality. In a clinic setting, the laboratory director may be a physician, but in a hospital or health system, the chief of pathology and head of the central laboratory often become responsible. POCT is thus at odds with both the clinical staff performing the test as well as the laboratory staff responsible for supervising the test. This conflict creates a situation ripe for errors. More >

IN CASE YOU MISSED IT...Whitehat Communications recently held a webinar on glucose meters in critical care settings. That event is now available on line as recordings as well as slides from the presentation.

 

Glucose Meters and the Critically Ill Patient  I  Wednesday, July 2, 2014
Courtney Lias, Ph.D., Director of the Division of Chemistry and Toxicology Devices and Ann Snyder, MT(ASCP) Medical Technologist with the CMS in the Division of Laboratory Services lead this webinar focusing on the uncertainty that has been building among hospital laboratory management and point of care coordinators over the future of glucose meter use for critically ill patients.

To access the recording and/or the slides, click here.

A POC Glucose Program Turned Upside Down:
How a 17-hospital system survived a rollout and new requirements

Anne Ford, CAP Today, July 2014

When Rosemary Frederick learned last year that her employer, North Shore-LIJ Health System of New York state, would be switching from the Roche Accu-Chek Inform I point-of-care glucose meter to the Inform II due to a maltose interference issue, she knew she and her colleagues were facing a heck of a lot of work. “I want you to realize the enormousness of this project,” says Frederick, who is the point-of-care manager for the health system’s core laboratories. “It wasn’t one hospital and 1,500 people. We had to roll out over 1,000 meters, and we had to train over 13,000 people system-wide.”

No 17-hospital, 6,000-bed insti­tution switches devices like that without a headache, but what Frederick and her colleagues got instead felt like a months-long migraine. Instead of the laborious but relatively straightforward conversion it had expected, North Shore-LIJ found itself facing down a massive, many-headed hydra of a project, one whose nature seemed to morph moment by moment. “This was an ever-changing landscape,” says Jordan Laser, MD. “There was never a day when we thought we had a good understand­ing as to what was expected of us.” Dr. Laser is the health system’s director of near-patient testing, associate medical director of Core Laboratories, medical director of pathology and laboratory medicine at Long Island Jewish Medical Campus, and senior director of cytogenetics and molecular pathology.

What brought about all this confusion? How did Frederick, Dr. Laser, and their team find their way through it? And what effect is it likely to have on patient care at North Shore–LIJ? Click here

FDA Moves on

Blood Glucose Meters
Manufacturers, Labs Wary of Big Changes
By Bill Malone, May 2014 Clinical Laboratory News: Volume 40, Number 5

Few laboratory instruments are as ubiquitous as the humble blood glucose meter. Yet in recent years, they have become essential not only for managing patients with diabetes, but also for improving outcomes for other groups of patients at the point-of-care. Studies connecting hyperglycemia with poor outcomes have led many hospitals to rely on the convenience of these meters for managing care across a spectrum of hospitalized patients.

Regulators, however, including the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS), have become increasingly concerned about this practice because none of the meters on the market are FDA-cleared for use in critically ill patients, such as in the emergency department or intensive care unit. In fact, manufacturers submit meters intended for hospital use as over-the-counter devices, which means that FDA clears them based on the same standard as the home-use meters found in drug stores. More >

AACC Supports FDA Effort

to Improve Blood Glucose Meters

But Believes the New Standards Could Encumber the Use of These Monitors Without Benefiting Patients

In January, the U.S. Food and Drug Administration (FDA) released draft guidance proposing separate performance and accuracy criteria for over-the-counter blood glucose meters used in the home and prescription blood glucose meters used in hospitals. AACC supports FDA's initiative to improve the quality of these devices and enhance patient care, but recommends revising this draft guidance to ensure that it does not unnecessarily increase the regulatory burden and costs on the healthcare system.

Blood glucose meters are best known in their over-the-counter form for helping many of the 19 million Americans with diabetes to manage their condition. These devices have also become essential for managing care for other groups of patients in hospitals in recent years, as studies have uncovered a connection between high blood sugar and poor outcomes. FDA has become increasingly concerned about this practice, however, because blood glucose meters aren't cleared for use in critically ill patients, who may present with physiological variables that could interfere with the accuracy of these devices. More >

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

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Last updated: 08/01/2014 Questions or corrections: editor@pointofcare.net. © 2014  BACK TO TOP