The federal agency that is responsible for test categorization is the FDA. To check whether a test is waived or nonwaived, you can go to the website below:
The Laboratory Director can also hold the positions of Clinical Consultant and, Technical Consultant in a nonwaived moderate complexity lab as long as he/she holds the correct qualifications. These qualifications include training or experience in the specialty or sub-specialty they will be overseeing.
Diabetes testing can be traced back to medieval times—and innovations in testing are being developed today and tomorrow. In this article, we will look at the past, present, and challenging future for this disease state. Additionally, we will look at key risk factors and the changing landscape for diagnosis. Let’s quickly review some basic information about diabetes. Diabetes mellitus describes a group of metabolic diseases characterized by elevated blood glucose or hyperglycemia.1 In persons with a normal metabolism, the consumption of food stimulates the pancreas to release an adequate amount of insulin to move glucose from the bloodstream into cells to produce energy…(Read More)
How to secure your access to patient data when switching electronic health record vendors
Who owns patient data in an electronic health record (EHR)? It’s a simple question with a complex answer. No longer confined to the shelves of a physician’s office, patient data is now shared and used by a myriad of organizations across healthcare: Other physicians and health systems, the EHR vendor, payers, and researchers, not to mention patients themselves. While primary care physicians often originate the medical record, the resulting data are not theirs alone.The implication? The traditional concept of ownership is unraveling as patient data migrates away from paper charts and takes up residence in the cloud. Experts now counsel physicians against the concept of data ownership entirely….(Read More)