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| |title=Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research | | |title=Introduction to Quality and Quality Management Systems |
| |subtitle=2022 Edition | | |subtitle= |
| |cover-image=Vial of blood to be tested.jpg | | |cover-image=Time-Quality-Money.png |
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| '''Title''': ''Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research'' | | ==''Introduction to Quality and Quality Management Systems''== |
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| '''Edition''': 2022 Edition
| | | type = content |
| | | | style = width: 500px; |
| '''Author for citation''': Shawn E. Douglas and Alan Vaughan
| | | text = This book should not be considered complete until this message box has been removed. This is a work in progress. |
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| '''License for content''': [https://creativecommons.org/licenses/by-sa/4.0/ Creative Commons Attribution-ShareAlike 4.0 International]
| | 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. |
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| '''Publication date''': January 2022
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| Medical labs of all types—from the clinical diagnostics labs of the [[hospital]] to the clinical research labs of a [[medical device]] manufacturer—at their heart have an overall goal of doing their part towards improving health outcomes among humans and animals. On the surface, this goal sounds relatively mundane; however, the work conducted in these laboratories is anything but mundane. From the use of advanced clinical [[workflows]] to the requirement of accurate and timely results, these labs are under a lot of stress to operate effectively, efficiently, and according to regulations. However, well-designed [[laboratory informatics]] solutions, when implemented, used, and maintained effectively, provide a means to better achieve that primary goal.
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| This guide addresses the medical diagnostics and research laboratories in their myriad forms, as well as how laboratory informatics solutions can benefit them. Yet it's more than "here's a laboratory, here's a software system: marry the two, and the magic begins!" These systems have their own intricacies, and its up to laboratory personnel, often not well-versed in such automation solutions, to evaluate and implement them. This guide addresses the numerous considerations that should be made beforehand, and it provides several chapters of resources to help practically put those considerations to work. It also addresses the usefulness of a requirements specification and how to put it to use. In particular, a slightly modified version of [[LII:LIMSpec 2019|LIMSpec]] is suggested to get the most out of developing and using any requirements specification as part of software and vendor selection.
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| (NOTE: The PDF output of this guide fails to properly list the references. To see the original document, with references, see [[LII:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research|here]].) | | ;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]] |
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| ;About this book
| | <!--Place all category tags here--> |
| :[[Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research/Introduction|Introduction]]
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| ;1. Introduction to medical diagnostics and research laboratories
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| :[[Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research/Introduction to medical diagnostics and research laboratories/Medical diagnostics lab|1.1 Medical diagnostics lab]]
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| :[[Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research/Introduction to medical diagnostics and research laboratories/Public health lab|1.2 Public health lab]]
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| :[[Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research/Introduction to medical diagnostics and research laboratories/Toxicology lab|1.3 Toxicology lab]]
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| :[[Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research/Introduction to medical diagnostics and research laboratories/Blood bank and transfusion lab|1.4 Blood bank and transfusion lab]]
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| :[[Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research/Introduction to medical diagnostics and research laboratories/Central and contract research lab|1.5 Central and contract research lab]]
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| :[[Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research/Introduction to medical diagnostics and research laboratories/Genetic diagnostics lab|1.6 Genetic diagnostics lab]]
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| :[[Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research/Introduction to medical diagnostics and research laboratories/Medical cannabis testing lab|1.7 Medical cannabis testing lab]]
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| ;2. Choosing laboratory informatics software for your lab
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| :[[Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research/Choosing laboratory informatics software for your lab/Evaluation and selection|2.1 Evaluation and selection]]
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| :[[Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research/Choosing laboratory informatics software for your lab/Implementation|2.2 Implementation]]
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| :[[Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research/Choosing laboratory informatics software for your lab/MSW, updates, and other contracted services|2.3 MSW, updates, and other contracted services]]
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| :[[Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research/Choosing laboratory informatics software for your lab/How a user requirements specification fits into the entire process|2.4 How a user requirements specification fits into the entire process]]
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| ;3. Resources for selecting and implementing informatics solutions: Part 1: Laboratory informatics vendors
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| :[[Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research/Resources for selecting and implementing informatics solutions: Part 1: Laboratory informatics vendors/LIMS vendors|3.1 LIMS vendors]]
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| :[[Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research/Resources for selecting and implementing informatics solutions: Part 1: Laboratory informatics vendors/LIS vendors|3.2 LIS vendors]]
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| :[[Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research/Resources for selecting and implementing informatics solutions: Part 1: Laboratory informatics vendors/ELN vendors|3.3 ELN vendors]]
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| :[[Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research/Resources for selecting and implementing informatics solutions: Part 1: Laboratory informatics vendors/Middleware vendors|3.4 Middleware vendors]]
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| ;4. Resources for selecting and implementing informatics solutions: Part 2: Other vendors and service providers
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| :[[Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research/Resources for selecting and implementing informatics solutions: Part 2: Other vendors and service providers/Medical diagnostics instrumentation and equipment vendors|4.1 Medical diagnostics instrumentation and equipment vendors]]
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| :[[Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research/Resources for selecting and implementing informatics solutions: Part 2: Other vendors and service providers/EHR vendors|4.2 EHR vendors]]
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| :[[Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research/Resources for selecting and implementing informatics solutions: Part 2: Other vendors and service providers/Laboratory business intelligence (BI) and workflow solution vendors|4.3 Laboratory business intelligence (BI) and workflow solution vendors]]
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| :[[Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research/Resources for selecting and implementing informatics solutions: Part 2: Other vendors and service providers/Laboratory billing service providers|4.4 Laboratory billing service providers]]
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| :[[Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research/Resources for selecting and implementing informatics solutions: Part 2: Other vendors and service providers/Consultants|4.5 Consultants]]
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| ;5. Resources for selecting and implementing informatics solutions: Part 3: Industry and community resources
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| :[[Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research/Resources for selecting and implementing informatics solutions: Part 3: Industry and community resources/Trade organizations|5.1 Trade organizations]]
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| :[[Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research/Resources for selecting and implementing informatics solutions: Part 3: Industry and community resources/Conferences and trade shows|5.2 Conferences and trade shows]]
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| :[[Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research/Resources for selecting and implementing informatics solutions: Part 3: Industry and community resources/User communities|5.3 User communities]]
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| :[[Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research/Resources for selecting and implementing informatics solutions: Part 3: Industry and community resources/Books and journals|5.4 Books and journals]]
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| :[[Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research/Resources for selecting and implementing informatics solutions: Part 3: Industry and community resources/Standards, regulations, and guidance|5.5 Standards, regulations, and guidance]]
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| :[[Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research/Resources for selecting and implementing informatics solutions: Part 3: Industry and community resources/Further reading|5.6 Further reading]]
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| :[[Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research/Resources for selecting and implementing informatics solutions: Part 3: Industry and community resources/LIMSpec|5.7 LIMSpec]]
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| ;6. Taking the next step
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| :[[Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research/Taking the next step/Conduct initial research into a specification document|6.1 Conduct initial research into a specification document]]
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| :[[Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research/Taking the next step/Issue some of the specification as part of a request for information (RFI)|6.2 Issue some of the specification as part of a request for information (RFI)]]
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| :[[Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research/Taking the next step/Respond to or open dialogue with vendors|6.3 Respond to or open dialogue with vendors]]
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| :[[Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research/Taking the next step/Finalize the requirements specification and choose a vendor|6.4 Finalize the requirements specification and choose a vendor]]
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| ;7. Closing remarks
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| :[[Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research/Closing remarks|7.1 Recap and closing]]
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| ;Appendix 1. Blank LIMSpec template for medical diagnostics and research labs
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| :[[Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research/Taking the next step/Blank LIMSpec template for medical diagnostics and research labs/Introduction and methodology|A1. Introduction and methodology]]
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| :[[Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research/Taking the next step/Blank LIMSpec template for medical diagnostics and research labs/Primary laboratory workflow|A2. Primary laboratory workflow]]
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| :[[Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research/Taking the next step/Blank LIMSpec template for medical diagnostics and research labs/Maintaining laboratory workflow and operations|A3. Maintaining laboratory workflow and operations]]
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| :[[Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research/Taking the next step/Blank LIMSpec template for medical diagnostics and research labs/Specialty laboratory functions|A4. Specialty laboratory functions]]
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| :[[Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research/Taking the next step/Blank LIMSpec template for medical diagnostics and research labs/Technology and performance improvements|A5. Technology and performance improvements]]
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| :[[Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research/Taking the next step/Blank LIMSpec template for medical diagnostics and research labs/Security and integrity of systems and operations|A6. Security and integrity of systems and operations]]
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| :[[Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research/Taking the next step/Blank LIMSpec template for medical diagnostics and research labs/Putting LIMSpec to Use|A7. Putting those requirements to practical use and caveats]]
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| :[[Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research/Taking the next step/Blank LIMSpec template for medical diagnostics and research labs/LIMSpec in Microsoft Word format|A8. LIMSpec in Microsoft Word format]]
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