Biomedical Laboratory Science

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Showing posts with label Validation. Show all posts
Showing posts with label Validation. Show all posts

Saturday, February 25, 2017

Before Automating The Blood Bank, Evaluate Compatibility With Existing Systems

Automation in the blood bank can be a turnaround time saver and staffing force multiplier. However, optimizing the testing workflow on the existing platforms should be the first order of business when considering new automation. There are companies that can be hired to do this, and they may present ways to optimize current analyzers with minor adjustments in the workflow process. Beginning with the end in mind, mapping the current workflow processes will provide a baseline for improving operations in any blood bank and laboratory.

Consider the laboratory structure. Is there a core laboratory concept with blood bank and microbiology located in the same workspace? Is it necessary to consider changes to the power, IT connections, and physical space in the planning process for new automation? Many laboratory structures limit the ability to share technologies and products, which creates operational gaps and challenges staffing models. Workflow process mapping will ensure that a lab leader has defined the many interconnected operations that impact the overall efficiency of a laboratory and point out key areas where automation may help make great strides in productivity. Placement of automation can allow for integration and cross training of the technical staff. A well-trained, cross-functional staff can be a great tool in generating efficiencies as well as reducing laboratorian burnout.



Saturday, October 29, 2016

Validation of Hematology Analyzers

Perhaps the most common laboratory procedure performed for hospital patients and outpatients is complete blood count (CBC) or CBC with differential. CBC serves as a screening and diagnostic test for a wide range of conditions and diseases as well as a monitoring tool for treatment and disease status. Given its foundational nature and despite its relative simplicity, the veracity of this basic blood testing is essential. Therefore, thorough validation testing on all new hematology analyzers must be performed to ensure patient safety.

It is reasonable to assume that a newly acquired piece of diagnostic equipment would run as intended, as manufacturers perform their own validation testing to prove intended use and to fulfill regulatory requirements prior to launching a product in the market. However, the ultimate responsibility of verifying instrument performance specifications and characteristics prior to the patient testing falls to the end-user laboratory.



Source: MedLabMag

Thursday, September 22, 2016

Research Antibody Reproducibility

It’s All About Validation

The reproducibility of scientific studies has become a major issue, leading to a lack of trust in scientific results from the academic and pharmaceutical research communities. While issues around reproducibility have been discussed for years, calls for action have been infrequent and half-hearted. Beginning in about 2012, a number of articles, letters, and editorials started appearing in Nature, Science and other publications, with some going so far as to call this a “reproducibility crisis.”


The lack of consistent research on antibody validation has contributed to the scientific reproducibility
crisis.
Source: genengnews

Friday, September 9, 2016

Validating the Performance of Body Fluid Specimens

In health care, the analysis of body fluids plays an important role in the diagnosis and management of a wide variety of conditions. Traditionally, clinical laboratorians have provided analysis of body fluid specimens without question while also recognizing the sometimes difficult work that goes into their collection. As standards for method validation and laboratory developed tests (LDTs) evolve, the analysis of body fluids is receiving increased attention from both laboratories and regulatory bodies.

The clinical laboratory’s overarching goal is to ensure accurate test results from all specimens. Therefore, it is the responsibility of every laboratory to investigate the analytical performance of the tests performed on the various fluid types accepted and to provide a context for result interpretation.



Source: medlabmag
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