Better questions, better answers: reporting vs. analytics

What are the questions about performance, risk, and opportunity that leaders of today’s modern medical laboratories are asking? What are the questions they could be asking, or don’t even know they should be asking?
Reporting is the static assessment of performance, from which leaders must extrapolate conclusions about risk and opportunity. Data analytics, on the other hand, enables users to interact with information dynamically. It capitalizes on real-time analytics and data warehousing technologies to allow querying of huge sets of data from multiple sources, inviting lab leaders to ask more sophisticated questions and get fuller answers than they have with reporting. Analytics can also reveal relationships between various data, generating smarter, more informed questions and prompting smarter, more informed action…(Read More Here)

Company’s Goal Is to Reduce Consumer’s Need to Visit Clinical Laboratories by Developing a Test Device for Home Monitoring of Fitness and Pre-Existing Conditions

Another biotech company has its eye on medical laboratory testing and wants to bring to market what it describes as a consumer do-it-yourself test device. The company is designing the device to let consumers do fitness monitoring. But it hopes the device will also allow consumers to monitor pre-existing conditions without the need to visit a clinical laboratory.

These are ambitious goals for Cambridge Consultants, a health IT engineering and technology development firm in Massachusetts. The device under development is the Flow Health Hub, which company executives say can bring the power of the clinical laboratory into the home, according to a Cambridge Consultants press release…(Read More Here)

Edition 9: Reportable Range

On January 24, 2003, the Centers for Medicare and Medicaid Services (CMS) published the final Clinical Laboratory Improvement Amendments (CLIA) regulations with an effective date of April 24, 2003. COLA revised their accreditation criteria, Criteria for Quality Laboratory Performance, with an effective date of June 1, 2007. The new CLIA and COLA regulations require that the laboratory verify the manufacturer’s performance specifications listed in their package inserts. The laboratory must verify accuracy, precision, reference range and reportable range for each non-waived test. This bulletin will address the verification of reportable range.

What is reportable range?
Reportable range is the lowest and highest result the test system can accurately report including all the values in between.…(Read More Here)

Edition 8: Calibration and Calibration Verification

On January 24, 2003, the Centers for Medicare and Medicaid Services (CMS) published the final Clinical Laboratory Improvement Amendments (CLIA) regulations with an effective date of April 24, 2003. Due to the updated CLIA regulations, COLA updated their accreditation criteria, Criteria for Quality Laboratory Performance, with an effective date of June 1, 2007. Since the release of both regulations, Vital Diagnostics has received numerous questions regarding the calibration and calibration verification requirements. The intent of this Technical Bulletin is to define calibration and calibration verification, explain the requirements and provide some insight into implementation.

CALIBRATION

What is calibration?
Calibration is the process of testing and adjusting an instrument or test system to establish a correlation between the measurement of the substance being tested and the actual concentration of the substance……(Read More Here)