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| Your laboratory's [[workflow]], instruments, data management requirements, budget, technological expertise, business goals, and risk tolerances will all play a role in deciding what technology to invest in. The [[Physician office laboratory|physician office lab]] (POL), with its easy-to-use point-of-care testing and relatively simplified laboratory procedures, will invest significantly less into analyzers, instruments, and laboratory software than the molecular diagnostics laboratory, for example. As such, look at your laboratory's short- and long-term goals, budget, workflow, and regulatory requirements to gain a better understanding of what technology will be involved.
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| | |title=Introduction to Quality and Quality Management Systems |
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| First, what are the laboratory's goals? Does the laboratory owner envision a small investment, taking in a slow but steady flow of simple clinical tests of human fluids, or expansive growth, expanding into multiple testing domains? If the lab is starting small but is confidently expecting to grow, technological investments early on may want to take into account future technologies that may shape data management and security processes. Second, what kind of work will the lab be doing, and what regulatory responsibilities will guide hardware and software investment at the lab? If your lab will be testing medical cannabis for the state or province's associated program, you'll be considering [[chromatography]] and [[spectroscopy]] instruments, as well as regulatory requirements for complete track-and-trace activities, including reporting. The [[public health laboratory]] will likely have many more instruments to cover all its testing needs, and its data management system will likely need to be able to use the [[Centers for Disease Control and Prevention]]'s PHIN Messaging System. Third, your laboratory's budget is ever important. Does the budget allow for on-site hardware and software systems, with the personnel to maintain them? Is it easier to pay up-front or find a vendor willing to work with you on leasing or rental terms? (We talk about other cost considerations a bit later.)
| | ==''Introduction to Quality and Quality Management Systems''== |
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| | | 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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| | 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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| Finally, will the lab have someone on-site or on-call to resolve technology issues, including set-up and maintenance of software systems? If your lab will have little in the way of available tech help locally, you'll want to consider the distribution model you want to use for any installed software, i.e., you may want to consider [[software as a service]]. An increasing number of software services are hosted using [[cloud computing]], which when done well is an increasingly reliable option.<ref name="IzrailevskyCloud18">{{cite journal |title=Cloud Reliability |journal=IEEE Cloud Computing |author=Izrailevsky, Y.; Bell, C. |volume=5 |issue=3 |pages=39–44 |year=2018 |doi=10.1109/MCC.2018.032591615}}</ref> Having someone else host the software for you typically means the hosting provider will carry a non-trivial portion of responsibility for technology maintenance and security. Speaking of security, you'll also want to consider the [[cybersecurity]] (addressed later) of not only your software solution but also your overall laboratory operations. Does your laboratory have a cybersecurity plan already in place, or has the decision to make one been postponed? What extra investment is required to ensure your sensitive data is secure? Remember that how you rank your cybersecurity preparedness and implement a cybersecurity plan will also guide your technology investment decisions.<ref name="DouglasComp20">{{cite web |title=[[LII:Comprehensive Guide to Developing and Implementing a Cybersecurity Plan|''Comprehensive Guide to Developing and Implementing a Cybersecurity Plan'']] |author=Douglas, S.E. |work=LIMSwiki |date=July 2020 |accessdate=18 November 2021}}</ref>
| | ;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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| '''2.1.1.1 Laboratory informatics options'''
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| [[File:Icos Laboratories.JPG|right|350px]]Keeping the above in mind, what are the common software solutions used within a medical diagnostic or research laboratory? One of the more commonly discussed options is the LIS or LIMS. In the past, the term "laboratory information system" or "LIS" was used for solutions designed for medical labs, whereas "laboratory information management system" or "LIMS" was commonly used for non-medical functionality. Over the years, some software vendors have blurred these distinctions, with "LIMS" being used interchangeably with "LIS" in vendor marketing. Today, you'll see both terms being used to reference a laboratory informatics solution designed to assist medical laboratories manage testing workflows, data, and other aspects of their operations.
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| A December 2019 survey by ''Medical Laboratory Observer'', consisting of 273 respondents, is somewhat revealing in what a LIS or LIMS is being used for by a medical laboratory. Ninety-five percent of respondents indicated they use it to streamline their electronic order entry and result management, with medical data connectivity being the second most popular use. Automation tools, customer relationship management, scheduling, inventory management, revenue management, quality management, and reporting were all also mentioned as important to users.<ref name="SilvaITSol19">{{cite web |url=https://www.mlo-online.com/information-technology/article/21117759/it-solutions-in-the-clinical-lab |title=IT solutions in the clinical lab |author=Silva, B. |work=Medical Laboratory Observer |date=19 December 2019 |accessdate=18 November 2021}}</ref> When asked to select from five choices (or provide some other reason) in regard to what their top priority was in selecting a LIS or LIMS, respondents indicated that their most important priority was providing data analysis mechanisms for all types of pathology. See Table 1 below for all responses.
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| | colspan="2" style="background-color:white; padding-left:10px; padding-right:10px;" |'''Table 1.''' ''MLO'' survey responses to what the top priority was when acquiring a LIS or LIMS<ref name="SilvaITSol19" />
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| ! style="padding-left:10px; padding-right:10px;" |Top acquisition priority for LIS or LIMS based on a survey; ''n'' = 273
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| ! style="padding-left:10px; padding-right:10px;" |Percentage of<br />respondents
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| | style="background-color:white; padding-left:10px; padding-right:10px;" |Analytic solutions for clinical/anatomical/molecular pathology
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| | style="background-color:white; padding-left:10px; padding-right:10px;" |36%
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| | style="background-color:white; padding-left:10px; padding-right:10px;" |Multi-lab networking/connectivity
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| | style="background-color:white; padding-left:10px; padding-right:10px;" |25%
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| | style="background-color:white; padding-left:10px; padding-right:10px;" |Integration with [[electronic medical record]]s (EMRs)
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| | style="background-color:white; padding-left:10px; padding-right:10px;" |21%
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| | style="background-color:white; padding-left:10px; padding-right:10px;" |Flexible management capabilities
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| | style="background-color:white; padding-left:10px; padding-right:10px;" |8%
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| | style="background-color:white; padding-left:10px; padding-right:10px;" |Real-time and/or automated inventory management
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| | style="background-color:white; padding-left:10px; padding-right:10px;" |6%
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| | style="background-color:white; padding-left:10px; padding-right:10px;" |Other (e.g., cost, patient safety needs, and training management)
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| | style="background-color:white; padding-left:10px; padding-right:10px;" |4%
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| These responses help paint a picture of what a LIS or LIMS can do, but there's definitely more to it. (See the next subsection on features and functions.) And other systems are also being used in medical laboratories. The previously mentioned ''MLO'' survey indicated that 68 percent of respondents came from a [[hospital]] laboratory, highlighting their importance in the medical diagnostic laboratory demographic. As such, we'd be remiss to not mention the [[hospital information system]] (HIS), a hospital-level information management system that often incorporates modular functionality similar to that of a LIS or LIMS. However, some such labs will often have their own laboratory data management solution independent of the HIS.
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| The survey also made reference the the EMR. This software, along with the [[electronic health record]] (EHR), is most prevalent among health care systems and other ambulatory providers, including physicians. (As of 2019, approximately 89.9 percent of U.S. physicians have adopted EMRs or EHRs.<ref name="ONC_EHRAdopt19">{{cite web |url=https://www.cdc.gov/nchs/fastats/electronic-medical-records.htm |title=Electronic Medical Records/Electronic Health Records (EMRs/EHRs) |publisher=Centers for Disease Control and Prevention |date=14 October 2021 |accessdate=18 November 2021}}</ref>) These systems act as portable, longitudinal collections of patient and population data and a convenient tool for documenting, monitoring, and managing health care delivery. Medical diagnostic laboratory workflow typically sees test data from a LIS get transferred to the respective patient's record in the EHR.<ref name="PerrottaValid16">{{cite journal |title=Validating Laboratory Results in Electronic Health Records: A College of American Pathologists Q-Probes Study |journal=Archives of Pathology and Laboratory Medicine |author=Perrotta, P.L.; Karcher, D.S. |volume=140 |issue=9 |pages=926–31 |year=2016 |doi=10.5858/arpa.2015-0320-CP |pmid=27575266 |pmc=PMC5513146}}</ref>
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| Finally, you may also see [[electronic laboratory notebook]]s (ELN) in medical research labs.<ref name="ManzelRequire13">{{cite journal |title=Requirement analysis for an electronic laboratory notebook for sustainable data management in biomedical research |journal=Studies in Health Technologies and Informatics |author=Menzel, J.; Weil, P.; Bittihn, P. et al. |volume=192 |page=1108 |year=2013 |doi=10.3233/978-1-61499-289-9-1108 |pmid=23920882}}</ref><ref name="GuerreroAnal16">{{cite journal |title=Analysis and Implementation of an Electronic Laboratory Notebook in a Biomedical Research Institute |journal=PLoS One |author=Guerrero, S.; Dujardin, G.; Cabrera-Andrade, A. et al. |volume=11 |issue=8 |at=e0160428 |year=2016 |doi=10.1371/journal.pone.0160428 |pmid=27479083 |pmc=PMC4968837}}</ref> This software acts as an electronic substitute for the traditional [[laboratory notebook]], assisting researchers with direct recording of experiment data, linking records, and protecting proprietary information. They can typically be integrated with other software systems as well.
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| Choosing the right software will largely depend on your laboratory type and what you wish to accomplish. We next review the base features of offerings like an LIS and LIMS, as well as the features required by sub-specialties of medical science.
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| ==References==
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| {{Reflist|colwidth=30em}}
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