CLSI publishes guideline paper

Clinical and Laboratory Standards Institute (CLSI; Wayne, Pennsylvania) recently published a new document, "Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline (EP25-A)." Stability of an in vitro diagnostic (IVD) reagent reflects its ability to maintain consistent performance characteristics over time. IVD reagents, in the context of this guideline, represent end-use consumable products sold for the purpose of performing clinical measurements on patient specimens or other samples.

Examples of such products are IVD reagent kits and their associated calibrators, controls, sample diluents, and system generic reagents. Manufacturers are responsible for ensuring that stability claims are developed from experimental designs and data analyses that are appropriate for each product's particular requirements and applications. EP25-A includes background information and typical content to consider when creating a stability testing plan for a particular product, logistics of performing the studies, recommended data analyses, and documentation of stability claims.

Blue Shield of California to pay out bonuses

Blue Shield of California (San Francisco) said that it will make $29.6 million in bonuses available to medical groups and IPAs in California, and will award the money based on performance. Blue Shield will pay medical groups and IPAs for high achievement and improvement in areas that its members care the most about — key clinical and patient experience metrics.

"At Blue Shield, we are committed to providing access to high quality care to our members," said Juan Davila, senior VP of network management at Blue Shield of California. "Participating in the pay-for-performance program allows us to encourage best practices from physicians, control the rising cost of health care, and ensure members receive access to the care they need."