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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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| ==''Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research'', 2022 Edition== | | ==''Introduction to Quality and Quality Management Systems''== |
| '''Title''': ''Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research'', 2021 Edition
| | {{ombox |
| | | | type = content |
| '''Author for citation''': Shawn E. Douglas and Alan Vaughan
| | | style = width: 500px; |
| | | | text = This book should not be considered complete until this message box has been removed. This is a work in progress. |
| '''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. |
| '''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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| The table of contents for ''Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research'' is as follows: | |
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| :[[User:Shawndouglas/sandbox/sublevel2|1. Introduction to medical diagnostics and research laboratories]]
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| ::1.1 Medical diagnostics lab
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| :::1.1.1 Pathology
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| ::::1.1.1.1 Anatomical vs. clinical pathology
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| ::::1.1.1.2 Forensic pathology
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| :::1.1.2 Physician office lab
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| :::1.1.3 Integrative medicine lab
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| ::1.2 Public health lab
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| ::1.3 Toxicology lab
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| ::1.4 Blood bank and transfusion lab
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| ::1.5 Central and contract research lab
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| :::1.5.1 Medical and other research in academia
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| ::1.6 Genetic diagnostics lab
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| :::1.6.1 Cytogenetics lab
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| ::1.7 Medical cannabis testing lab
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| :[[User:Shawndouglas/sandbox/sublevel3|2. Choosing laboratory informatics software for your lab]]
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| ::2.1 Evaluation and selection
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| :::2.1.1 Technology considerations
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| ::::2.1.1.1 Laboratory informatics options
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| :::2.1.2 Features and functions
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| :::2.1.3 Cybersecurity considerations
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| :::2.1.4 Regulatory compliance considerations
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| :::2.1.5 System flexibility
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| :::2.1.6 Cost considerations
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| ::2.2 Implementation
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| :::2.2.1 Internal and external integrations
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| ::2.3 MSW, updates, and other contracted services
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| ::2.4 How a user requirements specification fits into the entire process (LIMSpec)
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| :[[User:Shawndouglas/sandbox/sublevel4|3. Resources for selecting and implementing informatics solutions: Part 1: Laboratory informatics vendors]]
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| ::3.1 LIMS vendors
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| ::3.2 LIS vendors
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| ::3.3 ELN vendors
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| ::3.4 Middleware vendors
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| :[[User:Shawndouglas/sandbox/sublevel5|4. Resources for selecting and implementing informatics solutions: Part 2: Other vendors and service providers]]
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| ::4.1 Medical diagnostics instrumentation vendors
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| :::4.1.1 CLIA-certified vendors
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| :::4.1.2 Other vendors
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| ::4.2 EHR vendors
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| ::4.3 Laboratory business intelligence and workflow solution vendors
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| ::4.4 Laboratory billing service providers
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| ::4.5 Consultants
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| :[[User:Shawndouglas/sandbox/sublevel6|5. Resources for selecting and implementing informatics solutions: Part 3: Industry and community resources]]
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| ::5.1 Trade organizations
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| ::5.2 Conferences and trade shows
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| ::5.3 User communities
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| ::5.4 Books and journals
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| ::5.5 Standards
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| ::5.6 Further reading
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| ::5.7 LIMSpec
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| :[[User:Shawndouglas/sandbox/sublevel37|6. Taking the next step]]
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| ::6.1 Conduct initial research into a specification document tailored to your lab's needs
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| ::6.2 Issue some of the specification as part of a request for information (RFI)
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| ::6.3 Respond to or open dialogue with vendors
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| :::6.3.1 The value of demonstrations
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| ::6.4 Finalize the requirements specification and choose a vendor
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| :[[User:Shawndouglas/sandbox/sublevel38|7. Closing remarks]] | | ;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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| : Appendix 1. Blank LIMSpec template for medical diagnostics and research labs
| | <!--Place all category tags here--> |
| ::[[LII:LIMSpec/Introduction and methodology|A1.1 Introduction and methodology]]
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| ::[[LII:LIMSpec/Primary Laboratory Workflow|A1.2 Primary Laboratory Workflow]]
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| ::[[LII:LIMSpec/Maintaining Laboratory Workflow and Operations|A1.3 Maintaining Laboratory Workflow and Operations]]
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| ::[[User:Shawndouglas/sandbox/sublevel40|A1.4 Specialty Laboratory Functions]]
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| ::[[LII:LIMSpec/Technology and Performance Improvements|A1.5 Technology and Performance Improvements]]
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| ::[[LII:LIMSpec/Security and Integrity of Systems and Operations|A1.6 Security and Integrity of Systems and Operations]]
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| ::[[LII:LIMSpec/Putting LIMSpec to use|A1.7 Putting LIMSpec to Use]]
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| ::[[User:Shawndouglas/sandbox/sublevel41|A1.8 LIMSpec in Microsoft Word format]]
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