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Laboratory Quality as a Discipline

Laboratory Quality as a Specialized Field

Laboratory Medicine includes overlapping educational, service, and research areas. Even though quality in clinical laboratories is considered part of healthcare quality, due to some unique aspects of the laboratory's technical and operational aspects, laboratory quality became a well-characterized specialty and a professional discipline on its own.

Historically, pioneers of laboratory quality imported concepts from industrial engineering and applied them ina laboratory context. Over decades, these efforts overlapped with Total Quality Management to yield standards for operating the lab organization concerning quality.

Laboratory Quality is now considered a specialized area of expertise within healthcare on the level of standards and quality requirements, guidelines, and practical experience.

 

Complexity of laboratory operations: 

Though working behind the scenes, laboratory professionals operate within a complex set of operations and are required to produce “reliable” output in the form of accurate and smart results that aid in patient diagnosis and management.

The laboratory path of workflow begins with patient preparation, and ample collection and ends with reporting and results interpretation. This constitutes three phases, named pre-analytical, analytical, and post-analytical phases.

Lab Path of workflow is Error-Vulnerable:

Laboratory total testing process over the path of workflow is intrinsically error-prone. Multi-factors and many varied sources could affect the working accuracy and lead to erroneous results. A 

Quality Assurance system should be set in place to control the total testing process. Quality Assurance (QA) is intended to ensure the output through implementing planned and integrated QC measures.

Quality management is a wider circle or a higher view in a hierarchy that includes QA and QC. In a quality management system, all aspects of the laboratory operations, including the organizational structure, processes, and procedures, need to be addressed to assure quality.

                                                             

In the early 1990s, a new generation of LIMS emerged with the advantage of client/server architecture, allowing laboratories to implement better processing and exchange of data. This was a kind of necessity for proper information management.

Currently, information management is an essential chapter in national and international laboratory standards and is considered one of the (12) Quality System Essentials models introduced by CLSI (QSEs). 

LIMS greatly supported sample management and tracking, instrument connectivity, data exchange and integration, reporting cycle, and nearly all aspects of lab operations

Quality requirements of information management can be fairly met without LIMS in place. More interestingly, most up-to-date laboratory guidelines not only refer to LIMS as a cornerstone for proper management of data and information but also refer to “informatics” as new horizons for optimal use of information technologies are being implemented in clinical laboratories.

 

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