Clinical Laboratory News August 2014
An AACC Publication | Volume 40, Number 8
August 2014
CLIA Regulations
New Rules for Proficiency Testing
How to Avoid Getting Into Trouble
A new regulation from the Centers for Medicare and Medicaid Services lays out a new system of fines and other penalties for labs that refer proficiency testing samples.
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Quality Assurance
Bench Matters
Lyme Disease Testing: Strategies for Achieving Robust Results
Detection and treatment of Lyme disease remains controversial, with some patient advocacy groups concerned that tests are not sensitive enough and many clinicians concerned about over-diagnosis and over-treatment based on too many false positive results. Experts J. Stephen Dumler, MD, and Maria E. Aguero-Rosenfeld, MD, review the recommended testing algorithm for Lyme disease and propose solutions for labs to obtain robust test results.
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Lab management  
lab management  
Diagnostics Diagnosis
Survey Shows Doctors' Challenges, Labs' Opportunities in Better Test Ordering and Interpreting Tests
The number and complexity of clinical lab tests has grown rapidly in recent years, overwhelming primary care physicians (PCPs) in knowing which tests to order in what order, and in understanding the results of the tests. A recent survey looked at how often PCPs have uncertainty about ordering and about interpreting tests, and how they go about dealing with that uncertainty. The responses offer insight for laboratories in working with PCPs and helping them make better use of diagnostic tests.
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Evidence-based medicine  
The Spectrum of Wheat Sensitivity
From Non-Celiac Gluten Sensitivity to Celiac Disease
Celiac disease in its classical presentation includes a specific set of symptoms, but many people with the disease have something other than its classical form. Still other people have conditions related to wheat or gluten consumption that are not celiac disease at all. Due to this range of wheat- and gluten-related issues, doctors often encounter much confusing information in the scientific literature related to diagnosis and treatment of this array of ailments. When doctors fail to make timely diagnoses of patients with these conditions, furthermore, patients often face greater risks of illness and increased medical expenses.
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legal issues
Ask the Expert
Custom Test Panels Come With Compliance Risks
Government leaders have expressed concern about custom test panels, but Gregory Root, chief operating officer and general counsel of the consulting firm CodeMap, says that laboratories can avoid problems associated with the tests. Root writes that officials in the Office of the Inspector General are concerned that custom test panels will lead to unnecessary testing. He also writes, however, that laboratory staff can protect themselves by allowing doctors to take the lead in designing custom panels and by keeping thorough and accurate records
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  Federal Insider         The Sample
  Industry Playbook           Regulatory Roundup 
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