Bio/Data Corporation Affirms Outstanding Safety Compliance Worldwide
Bio/Data Corporation ensures that its Platelet Aggregometers, Platelet Function Centrifuges, and other powered accessories not only meet but exceed the necessary safety standards set by national, Canadian, and international regulatory bodies. Our commitment to quality and compliance is evident in the rigorous testing and adherence to industry benchmarks that characterize our products. By consistently aligning with and surpassing established standards, we affirm our dedication to delivering cutting-edge technology that not only meets the demands of the market but also upholds the highest levels of safety and performance on a global scale.
Bio/Data aligns with the goals of the Clinical and Laboratory Standards Institute (CLSI) to enhance laboratory performance and standardize quality benchmarks. We strongly encourage our customer laboratories to embrace CLSI Approved Standards and Guidelines. Further details can be found in our Reagent Instructions For Use reference section, providing comprehensive information on applicable approved standards and guidelines.
North American Specialized Coagulation Laboratory Association (NASCOLA)
Bio/Data is dedicated to offering products that aid clinical laboratories in meeting essential performance standards, ensuring the production of accurate and precise laboratory results. We actively engage in proficiency testing programs, the same ones relied upon by many of our customers as performance benchmarks.
These proficiency testing programs involve the regular dispatch of "unknown" samples to participating laboratories. These laboratories then conduct tests on the samples and submit their results to the sponsoring organizations. The reported results undergo grading and comparison, forming the basis for inter-laboratory assessments.
Notably, Bio/Data is actively involved in proficiency testing programs offered by NASCOLA (North American Specialized Coagulation Laboratories Association), a leading organization providing proficiency testing for hemostasis, coagulation, and platelet function testing. Participation in such programs underscores our commitment to maintaining high standards and contributing to the continual improvement of laboratory performance.
The College of American Pathologists (CAP), the preeminent organization of board-certified pathologists, dedicates itself to promoting excellence in the practice of pathology and laboratory medicine worldwide, serving patients, pathologists, and the public. CAP extends its influence by providing accreditation and proficiency testing to medical laboratories through its comprehensive laboratory quality solutions programs.
The roots of proficiency testing, initially known as surveys, can be traced back to 1949, representing a pivotal step in laboratories' efforts to assess and ensure accuracy. CAP's accreditation journey commenced in 1964, with the organization later gaining the authority to accredit medical laboratories in accordance with the Clinical Laboratory Improvement Amendments (CLIA) of 1988.
As a leading organization specializing in proficiency testing for hemostasis, coagulation, and platelet function testing, CAP plays a crucial role in advancing standards in the field. Bio/Data actively participates in these programs, reaffirming our commitment to upholding the highest levels of quality and accuracy in laboratory testing.
As the inaugural national standards organization globally, BSI British Standards boasts a universally acknowledged standing for its independence, integrity, and innovation in crafting standards and information products that advocate and disseminate best practices. Functioning as a primary provider of standardization and consortia services to both public and private sectors, BSI serves the interests of diverse industry sectors, governments, consumers, employees, and society at large. The organization's commitment is to ensure the utility, relevance, and authority of British, European, and international standards, thereby contributing to the advancement and well-being of various stakeholders.