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[[File:Medical Laboratory Scientist US NIH.jpg|right|400px]]Those who work in a [[Clinical laboratory|medical diagnostics]] or [[Medical research|research]] laboratory have a lot on their plate. (Or is that "on their slides"? "In their blood collection tubes"?) From small- to high-volume [[Laboratory|laboratories]], the analysts in them must follow strict [[Workflow|workflows]] and procedures in order to produce timely and accurate results for the best possible patient health outcomes. Many of those analysts will also have additional ancillary roles within the laboratory, including [[Quality control|controlling quality]], managing [[Regulatory compliance|regulatory]] and [[cybersecurity]] requirements, and managing and updating [[Document management system|documentation]]. Particularly in medical labs with significant volume, the chance for human error to impact operations and patient health may increase, requiring systematic and [[Continual improvement process|continual improvement]] approaches to collecting, [[Data analysis|analyzing]], and [[Information security|protecting]] patient data.<ref name="JafriError15">{{cite journal |title=Error identification in a high-volume clinical chemistry laboratory: Five-year experience |journal=Scandinavian Journal of Clinical and Laboratory Investigation |author=Jafri, L.; Khan, A.H.; Ghani, F. et al. |volume=75 |issue=4 |pages=296–300 |year=2015 |doi=10.3109/00365513.2015.1010175 |pmid=25723890}}</ref><ref name="AgarwalQuality14">{{cite journal |title=Quality-Improvement Measures as Effective Ways of Preventing Laboratory Errors |journal=Laboratory Medicine |author=Agarwal, R. |volume=45 |issue=2 |pages=e80–e88 |year=2014 |doi=10.1309/LMD0YIFPTOWZONAD}}</ref> The introduction of [[laboratory informatics]] solutions and other information technology within the medical diagnostic and research fields has made those approaches easier to adopt, resulting in smoother procedures and improved patient safety.<ref name="AgarwalQuality14" /><ref name="AlotaibiTheImpact17">{{cite journal |title=The impact of health information technology on patient safety |journal=Saudi Medical Journal |author=Alotaibi, Y.K.; Federico, F. |volume=38 |issue=12 |pages=1173–80 |year=2017 |doi=10.15537/smj.2017.12.20631 |pmid=29209664 |pmc=PMC5787626}}</ref><ref name="RaeenHowLab18">{{cite journal |url=https://dc.uthsc.edu/hiimappliedresearch/54/ |title=How Laboratory Informatics has Impacted Healthcare Overall |author=Raeen, M.R. |journal=Applied Research Projects |at=54 |year=2018 |doi=10.21007/chp.hiim.0056}}</ref>
{{Saved book
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Evaluating, selecting, implementing, and maintaining a laboratory informatics solution is no simple task, however. The laboratory team (or individual) taking these actions must consider their laboratory's business goals, current and future workflows, and the regulations that affect them, as well as the budget for the lab, its technology requirements, and its cybersecurity goals. And then of course there's the matter of understanding the options available and working with vendors to make the theoretical solution a reality, backed up with updates to training, business processes, and responsibilities within the organization. This can, for some, lead to a state of anxiety.
==''Introduction to Quality and Quality Management Systems''==
{{ombox
| type      = content
| style    = width: 500px;
| text      = This book should not be considered complete until this message box has been removed. This is a work in progress.
}}
The goal of this short volume is to act as an introduction to the quality management system. It collects several articles related to quality, quality management, and associated systems.


But the acquisition and implementation of a laboratory informatics solution doesn't have to be painful. With advance preparation and a full understanding of both how your lab's internal processes work and how acquiring a system should ideally occur, you'll be better prepared to take the leap.
;1. What is quality?
:''Key terms''
:[[Quality (business)|Quality]]
:[[Quality assurance]]
:[[Quality control]]
:''The rest''
:[[Data quality]]
:[[Information quality]]
:[[Nonconformity (quality)|Nonconformity]]
:[[Service quality]]
;2. Processes and improvement
:[[Business process]]
:[[Process capability]]
:[[Risk management]]
:[[Workflow]]
;3. Mechanisms for quality
:[[Acceptance testing]]
:[[Conformance testing]]
:[[Clinical quality management system]]
:[[Continual improvement process]]
:[[Corrective and preventive action]]
:[[Good manufacturing practice]]
:[[Malcolm Baldrige National Quality Improvement Act of 1987]]
:[[Quality management]]
:[[Quality management system]]
:[[Total quality management]]
;4. Quality standards
:[[ISO 9000]]
:[[ISO 13485]]
:[[ISO 14000|ISO 14001]]
:[[ISO 15189]]
:[[ISO/IEC 17025]]
:[[ISO/TS 16949]]
;5. Quality in software
:[[Software quality]]
:[[Software quality assurance]]
:[[Software quality management]]


This guide aims to assist you in that preparation, providing referenced information about the various processes and details of putting a laboratory informatics solution to work for you and your medical lab. We begin below by providing background on a variety of medical diagnostic and research laboratories, from pathology and [[Public health laboratory|public health labs]] to genetic diagnostic and central labs. Afterwards, the second chapter covers a wide array of considerations to make when evaluating, selecting, implementing, and maintaining an informatics solution, including an introduction to the benefits of a user requirements specification (URS) for that process. The third, fourth, and fifth chapters offer a wealth of resources for putting chapter two's information to use, including vendor lists, service providers, organizations, conferences, and other information sources. It also introduces LIMSpec, an ever-evolving software URS for laboratory informatics systems. The sixth chapter then gets into the nuts and bolts of the value of a URS, and more specifically LIMSpec, as well as how to get the most out of it. We provide closing comments afterwards, followed by an appendix that contains a blank version of the LIMSpec for medical diagnostic and research labs, along with a downloadable Microsoft Word version of the same document.
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==References==
{{Reflist|colwidth=30em}}

Latest revision as of 19:46, 9 February 2022

Introduction to Quality and Quality Management Systems
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Introduction to Quality and Quality Management Systems

This book should not be considered complete until this message box has been removed. This is a work in progress.

The goal of this short volume is to act as an introduction to the quality management system. It collects several articles related to quality, quality management, and associated systems.

1. What is quality?
Key terms
Quality
Quality assurance
Quality control
The rest
Data quality
Information quality
Nonconformity
Service quality
2. Processes and improvement
Business process
Process capability
Risk management
Workflow
3. Mechanisms for quality
Acceptance testing
Conformance testing
Clinical quality management system
Continual improvement process
Corrective and preventive action
Good manufacturing practice
Malcolm Baldrige National Quality Improvement Act of 1987
Quality management
Quality management system
Total quality management
4. Quality standards
ISO 9000
ISO 13485
ISO 14001
ISO 15189
ISO/IEC 17025
ISO/TS 16949
5. Quality in software
Software quality
Software quality assurance
Software quality management


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