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<div class="nonumtoc">__TOC__</div>
'''Title''': ''What standards and regulations affect a food and beverage laboratory?''
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| type      = notice
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| text      = This is sublevel4 of my sandbox, where I play with features and test MediaWiki code. If you wish to leave a comment for me, please see [[User_talk:Shawndouglas|my discussion page]] instead.<p></p>
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'''Author for citation''': Shawn E. Douglas
==Sandbox begins below==


'''License for content''': [https://creativecommons.org/licenses/by-sa/4.0/ Creative Commons Attribution-ShareAlike 4.0 International]
*Discussion and practical use of [[artificial intelligence]] (AI) in the [[laboratory]] is, perhaps to the surprise of some, not a recent phenomena. In the mid-1980s, researchers were developing computerized AI systems able "to develop automatic decision rules for follow-up analysis of &#91;[[clinical laboratory]]&#93; tests depending on prior information, thus avoiding the delays of traditional sequential testing and the costs of unnecessary parallel testing."<ref>{{Cite journal |last=Berger-Hershkowitz |first=H. |last2=Neuhauser |first2=D. |date=1987 |title=Artificial intelligence in the clinical laboratory |url=https://www.ccjm.org/content/54/3/165 |journal=Cleveland Clinic Journal of Medicine |volume=54 |issue=3 |pages=165–166 |doi=10.3949/ccjm.54.3.165 |issn=0891-1150 |pmid=3301059}}</ref> In fact, discussion of AI in general was ongoing even in the mid-1950s.<ref name="MinskyHeuristic56">{{cite book |url=https://books.google.com/books?hl=en&lr=&id=fvWNo6_IZGUC&oi=fnd&pg=PA1 |title=Heuristic Aspects of the Artificial Intelligence Problem |author=Minsky, M. |publisher=Ed Services Technical Information Agency |date=17 December 1956 |accessdate=16 February 2023}}</ref><ref>{{Cite journal |last=Minsky |first=Marvin |date=1961-01 |title=Steps toward Artificial Intelligence |url=http://ieeexplore.ieee.org/document/4066245/ |journal=Proceedings of the IRE |volume=49 |issue=1 |pages=8–30 |doi=10.1109/JRPROC.1961.287775 |issn=0096-8390}}</ref>


'''Publication date''':  
*Hiring demand for laboratorians with AI experience (2015–18) has historically been higher in non-healthcare industries, such as manufacturing, mining, and agriculture, shedding a light on how AI adoption in the clinical setting may be lacking. According to the Brookings Institute, "Even for the relatively-skilled job postings in hospitals, which includes doctors, nurses, medical technicians, research lab workers, and managers, only approximately 1 in 1,250 job postings required AI skills." They add: "AI adoption may be slow because it is not yet useful, or because it may not end up being as useful as we hope. While our view is that AI has great potential in health care, it is still an open question."<ref name=":11">{{Cite web |last=Goldfarb, A.; Teodoridis, F. |date=09 March 2022 |title=Why is AI adoption in health care lagging? |work=Series: The Economics and Regulation of Artificial Intelligence and Emerging Technologies |url=https://www.brookings.edu/research/why-is-ai-adoption-in-health-care-lagging/ |publisher=Brookings Institute |accessdate=17 February 2023}}</ref>


==Introduction==
*Today, AI is being practically used in not only clinical diagnostic laboratories but also clinical research labs, life science labs, and research and development (R&D) labs, and more. Practical uses of AI can be found in:


:clinical research labs<ref name=":0">{{Cite journal |last=Damiani |first=A. |last2=Masciocchi |first2=C. |last3=Lenkowicz |first3=J. |last4=Capocchiano |first4=N. D. |last5=Boldrini |first5=L. |last6=Tagliaferri |first6=L. |last7=Cesario |first7=A. |last8=Sergi |first8=P. |last9=Marchetti |first9=A. |last10=Luraschi |first10=A. |last11=Patarnello |first11=S. |date=2021-12-07 |title=Building an Artificial Intelligence Laboratory Based on Real World Data: The Experience of Gemelli Generator |url=https://www.frontiersin.org/articles/10.3389/fcomp.2021.768266/full |journal=Frontiers in Computer Science |volume=3 |pages=768266 |doi=10.3389/fcomp.2021.768266 |issn=2624-9898}}</ref>
:hospitals<ref name=":0" /><ref name=":1">{{Cite journal |last=University of California, San Francisco |last2=Adler-Milstein |first2=Julia |last3=Aggarwal |first3=Nakul |last4=University of Wisconsin-Madison |last5=Ahmed |first5=Mahnoor |last6=National Academy of Medicine |last7=Castner |first7=Jessica |last8=Castner Incorporated |last9=Evans |first9=Barbara J. |last10=University of Florida |last11=Gonzalez |first11=Andrew A. |date=2022-09-29 |title=Meeting the Moment: Addressing Barriers and Facilitating Clinical Adoption of Artificial Intelligence in Medical Diagnosis |url=https://nam.edu/meeting-the-moment-addressing-barriers-and-facilitating-clinical-adoption-of-artificial-intelligence-in-medical-diagnosis |journal=NAM Perspectives |volume=22 |issue=9 |doi=10.31478/202209c |pmc=PMC9875857 |pmid=36713769}}</ref>
:medical diagnostics labs<ref name=":1" /><ref name=":12">{{Cite web |last=Government Accountability Office (GAO); National Academy of Medicine (NAM) |date=September 2022 |title=Artificial Intelligence in Health Care: Benefits and Challenges of Machine Learning Technologies for Medical Diagnostics |url=https://www.gao.gov/assets/gao-22-104629.pdf |format=PDF |publisher=Government Accountability Office |accessdate=16 February 2023}}</ref><ref name=":13">{{Cite journal |last=Wen |first=Xiaoxia |last2=Leng |first2=Ping |last3=Wang |first3=Jiasi |last4=Yang |first4=Guishu |last5=Zu |first5=Ruiling |last6=Jia |first6=Xiaojiong |last7=Zhang |first7=Kaijiong |last8=Mengesha |first8=Birga Anteneh |last9=Huang |first9=Jian |last10=Wang |first10=Dongsheng |last11=Luo |first11=Huaichao |date=2022-09-24 |title=Clinlabomics: leveraging clinical laboratory data by data mining strategies |url=https://bmcbioinformatics.biomedcentral.com/articles/10.1186/s12859-022-04926-1 |journal=BMC Bioinformatics |language=en |volume=23 |issue=1 |pages=387 |doi=10.1186/s12859-022-04926-1 |issn=1471-2105 |pmc=PMC9509545 |pmid=36153474}}</ref><ref name=":7">{{Cite journal |last=DeYoung |first=B. |last2=Morales |first2=M. |last3=Giglio |first3=S. |date=2022-08-04 |title=Microbiology 2.0–A “behind the scenes” consideration for artificial intelligence applications for interpretive culture plate reading in routine diagnostic laboratories |url=https://www.frontiersin.org/articles/10.3389/fmicb.2022.976068/full |journal=Frontiers in Microbiology |volume=13 |pages=976068 |doi=10.3389/fmicb.2022.976068 |issn=1664-302X |pmc=PMC9386241 |pmid=35992715}}</ref><ref name=":5">{{Cite web |last=Schut, M. |date=01 December 2022 |title=Get better with bytes |url=https://www.amsterdamumc.org/en/research/news/get-better-with-bytes.htm |publisher=Amsterdam UMC |accessdate=16 February 2023}}</ref><ref name="AlbanoCal19">{{cite web |url=https://physicianslab.com/calculations-to-diagnosis-the-artificial-intelligence-shift-thats-already-happening/ |title=Calculations to Diagnosis: The Artificial Intelligence Shift That’s Already Happening |author=Albano, V.; Morris, C.; Kent, T. |work=Physicians Lab |date=06 December 2019 |accessdate=16 February 2023}}</ref>
:chromatography labs<ref name="AlbanoCal19" />
:biology and life science labs<ref name=":6">{{Cite journal |last=de Ridder |first=Dick |date=2019-01 |title=Artificial intelligence in the lab: ask not what your computer can do for you |url=https://onlinelibrary.wiley.com/doi/10.1111/1751-7915.13317 |journal=Microbial Biotechnology |language=en |volume=12 |issue=1 |pages=38–40 |doi=10.1111/1751-7915.13317 |pmc=PMC6302702 |pmid=30246499}}</ref>
:medical imaging centers<ref name="Brandao-de-ResendeAIWeb22">{{cite web |url=https://siim.org/page/22w_clinical_adoption_of_ai |title=AI Webinar: Clinical Adoption of AI Across Image Producing Specialties |author=Brandao-de-Resende, C.; Bui, M.; Daneshjou, R. et al. |publisher=Society for Imaging Informatics in Medicine |date=11 October 2022}}</ref>
:ophthalmology clinics<ref>{{Cite journal |last=He |first=Mingguang |last2=Li |first2=Zhixi |last3=Liu |first3=Chi |last4=Shi |first4=Danli |last5=Tan |first5=Zachary |date=2020-07 |title=Deployment of Artificial Intelligence in Real-World Practice: Opportunity and Challenge |url=https://journals.lww.com/10.1097/APO.0000000000000301 |journal=Asia-Pacific Journal of Ophthalmology |language=en |volume=9 |issue=4 |pages=299–307 |doi=10.1097/APO.0000000000000301 |issn=2162-0989}}</ref>
:reproduction clinics<ref name=":9">{{Cite journal |last=Trolice |first=Mark P. |last2=Curchoe |first2=Carol |last3=Quaas |first3=Alexander M |date=2021-07 |title=Artificial intelligence—the future is now |url=https://link.springer.com/10.1007/s10815-021-02272-4 |journal=Journal of Assisted Reproduction and Genetics |language=en |volume=38 |issue=7 |pages=1607–1612 |doi=10.1007/s10815-021-02272-4 |issn=1058-0468 |pmc=PMC8260235 |pmid=34231110}}</ref><ref name="ESHREArti22">{{cite web |url=https://www.focusonreproduction.eu/article/ESHRE-News-22AI |title=Annual Meeting 2022: Artificial intelligence in embryology and ART |author=European Society of Human Reproduction and Embryology |work=Focus on Reproduction |date=06 July 2022 |accessdate=16 February 2023}}</ref><ref name="HinckleyApply21">{{cite web |url=https://rscbayarea.com/blog/applying-ai-for-better-ivf-success |title=Applying AI (Artificial Intelligence) in the Lab for Better IVF Success |author=Hinckley, M. |work=Reproductive Science Center Blog |publisher=Reproductive Science Center of the Bay Area |date=17 March 2021 |accessdate=16 February 2023}}</ref>
:digital pathology labs<ref name="YousifArt21">{{cite web |url=https://clinlabint.com/artificial-intelligence-is-the-key-driver-for-digital-pathology-adoption/ |title=Artificial intelligence is the key driver for digital pathology adoption |author=Yousif, M.; McClintock, D.S.; Yao, K. |work=Clinical Laboratory Int |publisher=PanGlobal Media |date=2021 |accessdate=16 February 2023}}</ref>
:material testing labs<ref name=":2">{{Cite journal |last=MacLeod |first=B. P. |last2=Parlane |first2=F. G. L. |last3=Morrissey |first3=T. D. |last4=Häse |first4=F. |last5=Roch |first5=L. M. |last6=Dettelbach |first6=K. E. |last7=Moreira |first7=R. |last8=Yunker |first8=L. P. E. |last9=Rooney |first9=M. B. |last10=Deeth |first10=J. R. |last11=Lai |first11=V. |date=2020-05-15 |title=Self-driving laboratory for accelerated discovery of thin-film materials |url=https://www.science.org/doi/10.1126/sciadv.aaz8867 |journal=Science Advances |language=en |volume=6 |issue=20 |pages=eaaz8867 |doi=10.1126/sciadv.aaz8867 |issn=2375-2548 |pmc=PMC7220369 |pmid=32426501}}</ref><ref name=":3">{{Cite journal |last=Chibani |first=Siwar |last2=Coudert |first2=François-Xavier |date=2020-08-01 |title=Machine learning approaches for the prediction of materials properties |url=http://aip.scitation.org/doi/10.1063/5.0018384 |journal=APL Materials |language=en |volume=8 |issue=8 |pages=080701 |doi=10.1063/5.0018384 |issn=2166-532X}}</ref><ref name="MullinTheLab21">{{Cite journal |last=Mullin, R. |date=28 March 2021 |title=The lab of the future is now |url=http://cen.acs.org/business/informatics/lab-future-ai-automated-synthesis/99/i11 |journal=Chemical & Engineering News |volume=99 |issue=11 |archiveurl=https://web.archive.org/web/20220506192926/http://cen.acs.org/business/informatics/lab-future-ai-automated-synthesis/99/i11 |archivedate=06 May 2022 |accessdate=16 February 2023}}</ref>
:chemical experimentation and molecular discovery labs<ref name="MullinTheLab21" /><ref name=":4">{{Cite journal |last=Burger |first=Benjamin |last2=Maffettone |first2=Phillip M. |last3=Gusev |first3=Vladimir V. |last4=Aitchison |first4=Catherine M. |last5=Bai |first5=Yang |last6=Wang |first6=Xiaoyan |last7=Li |first7=Xiaobo |last8=Alston |first8=Ben M. |last9=Li |first9=Buyi |last10=Clowes |first10=Rob |last11=Rankin |first11=Nicola |date=2020-07-09 |title=A mobile robotic chemist |url=https://www.nature.com/articles/s41586-020-2442-2.epdf?sharing_token=HOkIS6P5VIAo2_l3nRELmdRgN0jAjWel9jnR3ZoTv0Nw4yZPDO1jBpP52iNWHbb8TakOkK906_UHcWPTvNxCmzSMpAYlNAZfh29cFr7WwODI2U6eWv38Yq2K8odHCi-qwHcEDP18OjAmH-0KgsVgL5CpoEaQTCvbmhXDSyoGs6tIMe1nuABTeP58z6Ck3uULcdCtVQ66X244FsI7uH8GnA%3D%3D&tracking_referrer=cen.acs.org |journal=Nature |language=en |volume=583 |issue=7815 |pages=237–241 |doi=10.1038/s41586-020-2442-2 |issn=0028-0836}}</ref><ref name="LemonickExplore20">{{Cite journal |last=Lemonick, S. |date=06 April 2020 |title=Exploring chemical space: Can AI take us where no human has gone before? |url=https://cen.acs.org/physical-chemistry/computational-chemistry/Exploring-chemical-space-AI-take/98/i13 |journal=Chemical & Engineering News |volume=98 |issue=13 |archiveurl=https://web.archive.org/web/20200729004137/https://cen.acs.org/physical-chemistry/computational-chemistry/Exploring-chemical-space-AI-take/98/i13 |archivedate=29 July 2020 |accessdate=16 February 2023}}</ref>
:quantum physics labs<ref name="DoctrowArti19">{{cite web |url=https://www.pnas.org/post/podcast/artificial-intelligence-laboratory |title=Artificial intelligence in the laboratory |author=Doctrow, B. |work=PNAS Science Sessions |date=16 December 2019 |accessdate=16 February 2023}}</ref>


This brief topical article will examine the standards, regulations, and other factors globally influencing not only the demand for food and beverage testing—typically out of the need for safety and quality— but also how related laboratory activities may be conducted.
*What's going on in these labs?


:'''Materials science''': The creation of "a modular robotic platform driven by a model-based optimization algorithm capable of autonomously optimizing the optical and electronic properties of thin-film materials by modifying the film composition and processing conditions ..."<ref name=":2" />
:'''Materials science''': "Most of the applications of [machine learning (ML)] in chemical and materials sciences, as we have said, feature supervised learning algorithms. The goal there is to supplement or replace traditional modeling methods, at the quantum chemical or classical level, in order to predict the properties of molecules or materials directly from their structure or their chemical composition ... Our research group was applying the same idea on a narrower range of materials, trying to confirm that for a given chemical composition, geometrical descriptors of a material’s structure could lead to accurate predictions of its mechanical features."<ref name=":3" />
:'''Life science''': "In biological experiments, we generally cannot as easily declare victory, but we can use the systems biology approach of cycling between experimentation and modelling to see which sequences, when tested, are most likely to improve the model. In artificial intelligence, this is called active learning, and it has some similarity to the way in which we as humans learn as infants: we get some help from parents and teachers, but mainly model the world around us by exploring it and interacting with it. Ideally then, we would recreate such an environment for our machine learning algorithms in the laboratory, where we start with an initial ‘infant’ model of a certain regulatory system or protein function and let the computer decide what sequence designs to try out – a deep learning version of the ‘robot scientist’. Microbes are ideal organisms for such an approach, given the ease and speed with which they can be grown and genetically manipulated. Combined with laboratory automation, many microbial experiments can (soon) be performed with minimal human intervention, ranging from strain construction and screening, such as operated by Amyris, Gingko, Transcriptic, etc., to full-genome engineering or even the design of microbial ecologies."<ref name=":6" />
:'''Digital pathology''': "The collaboration combines two AI solutions, VistaPath’s Sentinel, the world’s first automated tissue grossing platform, and Gestalt’s AI Requisition Engine (AIRE), a leading-edge AI algorithm for accessioning, to raise the bar in AI-driven pathology digitization. Designed to make tissue grossing faster and more accurate, VistaPath’s Sentinel uses a high-quality video system to assess specimens and create a gross report 93% faster than human technicians with 43% more accuracy. It not only improves on quality by continuously monitoring the cassette, container, and tissue to reduce mislabeling and specimen mix-up, but also increases traceability by retaining original images for downstream review."<ref>{{Cite web |last=VistaPath |date=28 July 2022 |title=VistaPath Launches New Collaboration with Gestalt Diagnostics to Further Accelerate Pathology Digitization |work=PR Newswire |url=https://www.prnewswire.com/news-releases/vistapath-launches-new-collaboration-with-gestalt-diagnostics-to-further-accelerate-pathology-digitization-301594718.html |publisher=Cision US Inc |accessdate=17 February 2023}}</ref>
:'''Chemistry and molecular science''': "The benefits of combining automated experimentation with a layer of artificial intelligence (AI) have been demonstrated for flow reactors, photovoltaic films, organic synthesis, perovskites and in formulation problems. However, so far no approaches have integrated mobile robotics with AI for chemical experiments. Here, we built Bayesian optimization into a mobile robotic workflow to conduct photocatalysis experiments within a ten-dimensional space."<ref name=":4" />
:'''Chemistry and immunology''': "Chemistry and immunology laboratories are particularly well-suited to leverage machine learning because they generate large, highly structured data sets, Schulz and others wrote in a separate review paper. Labor-intensive processes used for interpretation and quality control of electrophoresis traces and mass spectra could benefit from automation as the technology improves, they said. Clinical chemistry laboratories also generate digital images—such as urine sediment analysis—that may be highly conducive to semiautomated analyses, given advances in computer vision, the paper noted."<ref name=":8">{{Cite web |last=Blum, K. |date=01 January 2023 |title=A Status Report on AI in Laboratory Medicine |work=Clinical Laboratory News |url=https://www.aacc.org/cln/articles/2023/janfeb/a-status-report-on-ai-in-laboratory-medicine |publisher=American Association for Clinical Chemistry |accessdate=17 February 2023}}</ref>
:'''Clinical research''': "... retrospective analysis of existing patient data for descriptive and clustering purposes [and] automation of knowledge extraction, ranging from text mining, patient selection for trials, to generation of new research hypotheses ..."<ref name=":0" />
:'''Clinical research''': "AI ... offers a further layer to the laboratory system by analyzing all experimental data collected by experiment devices, whether it be a sensor or a collaborative robot. From data collected, AI is able to produce hypotheses and predict which combination of materials or temperature is desired for the experiment. In short, this system will allow scientists to be aided by a highly intelligent system which is constantly monitoring and analyzing the experimental output. In this way, AI will help an experiment from its inception to conclusion."<ref>{{Cite web |last=Chubb, P. |date=03 November 2020 |title=How disruptive technology is helping laboratories combat COVID-19 |url=https://datafloq.com/read/disruptive-technologies-lab-help-us-prepare-future-pandemics/ |publisher=Datafloq |accessdate=16 February 2023}}</ref>
:'''Clinical research/medical diagnostics''': "Artificial intelligence (AI) in the laboratory is primarily used to make sense of big data, the almost impossibly large sets of data that biologists and pharmaceutical R&D teams are accustomed to working with. AI algorithms can parse large amounts of data in a short amount of time and turn that data into visualizations that viewers can easily understand. In certain data-intensive fields, such as genomic testing and virus research, AI algorithms are the best way to sort through the data and do some of the pattern recognition work."<ref>{{Cite web |last=Stewart, B. |date=18 March 2021 |title=Using LIMS for Data Visualization |work=CSols Insights |url=https://www.csolsinc.com/insights/published-articles/using-lims-for-data-visualization/ |publisher=CSols, Inc |accessdate=17 February 2023}}</ref>
:'''Medical diagnostics''': Development and implementation of [[Clinical decision support system|clinical decision support systems]] <ref name=":0" /><ref name=":1" />
:'''Medical diagnostics''': "Finally, in the laboratory, AI reduces the number of unnecessary blood samples when diagnosing infection. Instead of the 'gold standard blood sample' that takes 24-72 hours, the algorithm can predict the outcome of the blood sample with almost 80% accuracy based on demographics, vital signs, medications, and laboratory and radiology results. These are all examples of how Artificial Intelligence can be used to test better and faster with information that already exists. This saves time and costs."<ref name=":5" />
:'''Medical diagnostics''': "Chang sees two overarching classes of AI models: those that tackle internal challenges in the lab, such as how to deliver more accurate results to clinicians; and those that seek to identify cohorts of patients and care processes to close quality gaps in health delivery systems. The lab, however, 'isn’t truly an island,' said Michelle Stoffel, MD, PhD, associate chief medical information officer for laboratory medicine and pathology at M Health Fairview and the University of Minnesota in Minneapolis. 'When other healthcare professionals are working with electronic health records or other applications, there could be AI-driven tools, or algorithms used by an institution’s systems that may draw on laboratory data.'"<ref name=":8" />
:'''Medical diagnostics''': AI is used for the formulation of reference ranges, improvement of quality control, and automated interpretation of results. "Continuous monitoring of specimen acceptability, collection and transport can result in the prompt identification and correction of problems, leading to improved patient care and a reduction in unnecessary redraws and delays in reporting results."<ref name=":13" />
:'''Reproduction science''': "The field of AI is the marriage of humans and computers while reproductive medicine combines clinical medicine and the scientific laboratory of embryology. The application of AI has the potential to disconnect healthcare professionals from patients through algorithms, automated communication, and clinical imaging. However, in the embryology laboratory, AI, with its focus on gametes and embryos, can avoid the same risk of distancing from the patient. Areas of application of AI in the laboratory would be to enhance and automate embryo ranking through analysis of images, the ultimate goal being to predict successful implantation. Might such a trend obviate the need for embryo morphological assessment, time-lapse imaging and preimplantation genetic testing for aneuploidy (PGT-A), including mosaicism. Additionally, AI could assist with automation through analysis of testicular sperm samples searching for viable gametes, embryo grading uniformity."<ref name=":9" />
:'''Chromatography-heavy sciences''': " A great example of this is AI in the Liquid Chromatography Mass Spectrometry (LC-MS) field. LC-MS is a great tool used to measure various compounds in the human body, including everything from hormone levels to trace metals. One of the ways AI has already integrated with LC-MS is how it cuts down on the rate limiting steps of LC-MS, which more often than not are sample prep and LC separations. One system that Physicians Lab has made use of is parallel processing using SCIEX MPX 2.0 High Throughput System. This system can couple parallel runs with one LCMS instrument, resulting in twice the speed with no loss to accuracy. It can do this by staggering two runs either using the same method, or different methods entirely. What really makes this system great is its ability to automatically detect carryover and inject solvent blanks to clean the instrument. The system will then continue its analyzing, while automatically reinjecting samples that may be affected by the carryover. It will also flag high concentration without user input, allowing for easy detection of possibly faulty samples. This allows it to operate without users from startup to shut down. Some of the other ways that it can be used to increase efficiency are by using integrated network features to work on anything from streamlining management to increased throughput."<ref name="AlbanoCal19" />
:'''Most any lab''': "Predictive analytics, for example, is one tool that the Pistoia Alliance is using to better understand laboratory instruments and how they might fail over time... With the right data management strategies and careful consideration of metadata, how to best store data so that it can be used in future AI and ML workflows is essential to the pursuit of AI in the laboratory. Utilizing technologies such as LIMS and ELN enables lab users to catalogue data, providing context and instrument parameters that can then be fed into AI or ML systems. Without the correct data or with mismatched data types, AI and ML will not be possible, or at the very least, could provide undue bias trying to compare data from disparate sources."<ref>{{Cite web |date=29 January 2021 |title=Data Analytics |work=Scientific Computing World - Building a Smart Laboratory 2020 |url=https://www.scientific-computing.com/feature/data-analytics-0 |publisher=Europa Science Ltd |accessdate=17 February 2023}}</ref>
:'''Most any lab''': "When the actionable items are automatically created by Optima, the 'engine' starts working. An extremely sophisticated algorithm is able to assign the tasks to the resources, both laboratory personnel and instruments, according to the system configuration. Optima, thanks to a large amount of time dedicated to research the best way to automate this critical process, is able to automate most of the lab resource scheduling."<ref>{{Cite web |last=Optima Team |date=15 December 2020 |title=The concept of machine learning applied to lab resources scheduling |work=Optima Blog |url=https://www.optima.life/blog/the-concept-of-machine-learning-applied-to-lab-resources-scheduling/ |publisher=Optima PLC Tracking Tools S.L |accessdate=17 February 2023}}</ref>


==Globally recognized food safety standards==
*A number of challenges exist in the realm of effectively and securely implementing AI in the laboratory. This includes:
Implementing and maintaining conformance to internationally recognized and benchmarked food safety standards benefits the food and beverage organization in a number of ways<ref name="PavlovićWhat17">{{cite web |url=https://www.ideagen.com/thought-leadership/blog/what-is-brc-global-food-safety-standard-explained |title=What is BRC? Global food safety standard explained |author=Pavlović, A. |work=Ideagen Blog |publisher=Ideagen Limited |date=26 June 2017 |accessdate=10 November 2022}}</ref><ref name="PJBRCGS20">{{cite web |url=https://www.pjfsc.com/Downloads/BRC-Overview.pdf |format=PDF |title=BRCGS - British Retail Consortium Global Standard |publisher=Perry Johnson Food Safety Consulting, Inc |date=April 2020 |accessdate=10  November 2022}}</ref>:


*It increases customer confidence through the organization's audited certification to the standard, taking the place of customers' own auditing methods to ensure quality and authenticity, in turn reducing time and costs.
:Ethical and privacy challenges<ref name=":0" /><ref name=":8" /><ref name=":10" />
*It drives organizations to better monitor their activities for non-conformities, identify root causes, and develop preventative controls, while clearly reporting such efforts to customers, further reducing the need for customer audits.
:Algorithmic limitations<ref name=":11" />
*It better ensures a rigorous and comprehensive approach to product safety, quality, integrity, and legality, in many cases meeting or exceeding local, state, federal, and/or international legislative requirements.
:Data access limitations, including "where to get it, how to share it, and how to know when you have enough to train a machine-learning system that will produce good results"<ref name=":11" /><ref name=":8" /><ref name=":14">{{Cite web |last=Sherwood, L. |date=10 February 2022 |title=SLAS 2022: Barriers remain to AI adoption in life sciences |work=LabPulse.com Showcasts |url=https://www.labpulse.com/showcasts/slas/2022/article/15300130/slas-2022-barriers-remain-to-ai-adoption-in-life-sciences |publisher=Science and Medicine Group |accessdate=17 February 2023}}</ref><ref name=":15">{{Cite journal |last=Bellini |first=Claudia |last2=Padoan |first2=Andrea |last3=Carobene |first3=Anna |last4=Guerranti |first4=Roberto |date=2022-11-25 |title=A survey on Artificial Intelligence and Big Data utilisation in Italian clinical laboratories |url=https://www.degruyter.com/document/doi/10.1515/cclm-2022-0680/html |journal=Clinical Chemistry and Laboratory Medicine (CCLM) |language=en |volume=60 |issue=12 |pages=2017–2026 |doi=10.1515/cclm-2022-0680 |issn=1434-6621}}</ref>
*It drives organizations to better vet their suppliers and service providers for meeting required food safety management practices.
:Data integration and transformation issues<ref name=":0" /><ref name=":15" />
*It enables organizations to better demonstrate auditable compliance with modern food safety management practices.
:Regulatory barriers<ref name=":11" /><ref name=":12" />
*It allows organizations to limit product recalls, reduce customer complaints, and better protect their brand.
:Misaligned incentives<ref name=":11" />
:Lack of knowledgeable/skilled talent<ref name=":0" /><ref name=":8" /><ref name=":14" /><ref name=":15" />
:Cost of skilled talent and infrastructure for maintaining and updating AI systems<ref name=":8" />
:Legacy systems running outdated technologies<ref name=":14" />
:Lack of IT systems or specialized software systems<ref name=":15" />
:Lack of standardized, best practices-based methods of validating algorithms<ref name=":8" />
:Failure to demonstrate real-world performance<ref name=":12" />
:Failure to meet the needs of the professionals using it<ref name=":12" />


As such, food and beverage developers and manufacturers adopt standards from one or more organizations around the world, not only to benefit their operations but also meet or exceed regulatory requirements for their industry. What follows are some of the more critical standards and guidelines that apply to the food, beverage, and feed industry.
*Given those challenges, some considerations should be made about implementing AI-based components in the laboratory. Examples include:


===British Retail Consortium (BRC) Global Standard for Food Safety (GSFS)===
:'''Clinical diagnostics''': "From an industry and regulatory perspective, however, only the intended uses supported from the media manufacturer can be supported from AI applications, unless otherwise justified and substantive evidence is presented for additional claims support. This means strict adherence to specimen type and incubation conditions. Considering that the media was initially developed for human assessment using the well-trained microbiologist eye, and not an advanced imaging system with or without AI, this paradigm should shift to allow advancements in technology to challenge the status-quo of decreasing media read-times especially, as decreased read-times assist with laboratory turnaround times and thus patient management. Perhaps with an increasing body of evidence to support any proposed indications for use, either regulatory positions should be challenged, or manufacturers of media and industry AI-development specialists should work together to advance the field with new indications for use.
In 1998, the [[wikipedia:British Retail Consortium|British Retail Consortium]] (BRD) published the first edition of its Global Standard for Food Safety (GSFS), going on to becoming an internationally recognized standard of best practices in food manufacturing, storage, and distribution, and the first food safety standard to be recognized by the Global Food Safety Initiative (GFSI). The standard covers stakeholder buy-in on continual improvement, food safety plan development, food quality management system development, manufacturing and storage site standardization, product and process control, personnel management, risk management, and trade product management.<ref name="PavlovićWhat17" /><ref name="PJBRCGS20" /><ref name="EagleFood19">{{cite web |url=https://vertassets.blob.core.windows.net/download/45fe7af4/45fe7af4-0500-4163-bd2b-5dd34e824bfd/eagle_wp_food_safetyquality_regulations_guide_a4_en.pdf |format=PDF |title=Food Safety and Quality Regulations: A Guide to Global Standards |publisher=Eagle Product Inspection |date=May 2019 |accessdate=10 November 2022}}</ref><ref name="BRCGSFS8_18">{{cite web |url=https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf |format=PDF |title=Global Standard Food Safety |author=British Retail Consortium |publisher=British Retail Consortium |date=August 2018 |accessdate=10 November 2022}}</ref> The standard is implemented by an organization through gap assessment, documentation development, consultation and assessment, internal auditing, and resolving non-conformances to the standard.<ref name="PJBRCGS20" />
:While the use of AI in the laboratory setting can be highly beneficial there are still some issues to be addressed. The first being phenotypically distinct single organism polymorphisms that may be interpreted by AI as separate organisms, as may also be the case for a human assessment, as well as small colony variant categorization. As detailed earlier, the broader the inputs, the greater the generalization of the model, and the higher the likelihood of algorithm accuracy. In that respect, understanding and planning around these design constraints is critical for ultimate deployment of algorithms. Additionally, expecting an AI system to correctly categorize “contamination” is a difficult task as often this again seemingly innocuous decision is dependent on years of experience and understanding the specimen type and the full clinical picture with detailed clinical histories. In this respect, a fully integrated AI-LIS system where all data is available may assist, but it is currently not possible to gather this granular detail needed to make this assessment reliable."<ref name=":7" />
 
:'''Clinical diagnostics and pathology''': "Well, if I’ve learned anything in my research into this topic, it’s that AI implementation needs to be a two-way street. First, any company who is active in this space must reach out to pathologists and laboratory medicine professionals to understand their daily workflows, needs, and pain points in as much detail as possible. Second, pathologists, laboratory medicine professionals, and educators must all play their important part – willingly offering their time and expertise when it is sought or proactively getting involved. And finally, it’s clear that there is an imbalanced focus on certain issues – with privacy, respect, and sustainability falling by the wayside."<ref name=":10">{{Cite web |last=Lee, G.F. |date=10 October 2022 |title=The Robot May See You Now: It’s time to stop and think about the ethics of artificial intelligence |work=The Pathologist |url=https://thepathologist.com/outside-the-lab/the-robot-may-see-you-now |accessdate=17 February 2023}}</ref>
===Codex Alimentarius===
:'''Healthcare''': "While we are encouraged by the promise shown by AI in healthcare, and more broadly welcome the use of digital technologies in improving clinical outcomes and health system productivity, we also recognize that caution must be exercised when introducing any new healthcare technology. Working with colleagues across the NHS Transformation Directorate, as well as the wider AI community, we have been developing a framework to evaluate AI-enabled solutions in the health and care policy context. The aim of the framework is several-fold but is, at its core, a tool with which to highlight to healthcare commissioners, end users, patients and members of the public the considerations to be mindful when introducing AI to healthcare settings."<ref>{{Cite journal |last=Chada |first=Bharadwaj V |last2=Summers |first2=Leanne |date=2022-10-10 |title=AI in the NHS: a framework for adoption |url=https://www.rcpjournals.org/lookup/doi/10.7861/fhj.2022-0068 |journal=Future Healthcare Journal |language=en |pages=fhj.2022–0068 |doi=10.7861/fhj.2022-0068 |issn=2514-6645 |pmc=PMC9761451 |pmid=36561823}}</ref>
The [[wikipedia:Codex Alimentarius|Codex Alimentarius]] is a collection of internationally recognized set of food and feed standards and guidelines developed as a joint venture between the United Nation's Food and Agricultural Organization (FAO) and the [[World Health Organization]] (WHO).<ref name="EagleFood19" /> The Codex "is intended to guide and promote the elaboration and establishment of definitions and requirements for foods to assist in their harmonization and in doing so to facilitate international trade."<ref name="FAOCodexAbout">{{cite web |url=https://www.fao.org/fao-who-codexalimentarius/about-codex/en/#c453333 |title=About Codex Alimentarius |publisher=Food and Agricultural Organization |date=2022 |accessdate=10 November 2022}}</ref> Scope of the standards is broad, covering food hygiene; food additives and contaminants, including pesticides and drugs; packaging and labelling; sampling and analysis methods; and import and export inspection and certification.<ref name="FAOCodexAbout" /> It's not unusual for governments to approach the FAO seek help with harmonizing national legal frameworks of food safety with the Codex Alimentarius.<ref name="FOAFood22">{{cite web |url=https://www.fao.org/food-safety/food-control-systems/policy-and-legal-frameworks/food-laws-and-regulations/en/ |title=Food laws & regulations |publisher=Food and Agricultural Organization |date=2022 |accessdate=10 November 2022}}</ref> Among the Codex, some of the more broadly useful standards include General Principles of Food Hygiene (CXC 1-1969)<ref name="FAOCodes22">{{cite web |url=https://www.fao.org/fao-who-codexalimentarius/codex-texts/codes-of-practice/en/ |title=Codes of Practice |work=Codex Alimentarius |publisher=Food and Agricultural Organization |date=2022 |accessdate=10 November 2022}}</ref>, General Standard for Contaminants and Toxins in Food and Feed (CXS 193-1995), and General Methods of Analysis for Contaminants (CXS 228-2001).<ref name="FAOContam22">{{cite web |url=https://www.fao.org/fao-who-codexalimentarius/thematic-areas/contaminants/en/ |title=Contaminants |work=Codex Alimentarius |publisher=Food and Agricultural Organization |date=2022 |accessdate=10 November 2022}}</ref>
:'''Most any lab''': A code of AI ethics should address objectivity, privacy, transparency, accountability, and sustainability in any AI implementation.<ref name=":10" />
 
:'''Most any lab''': "Another approach is to implement an AI program alongside a manual process, assessing its performance along the way, as a means to ease into using the program. 'I think one of the most impactful things that laboratorians can do today is to help make sure that the lab data that they’re generating is as robust as possible, because these AI tools rely on new training sets, and their performance is really only going to be as good as the training data sets they’re given,' Stoffel said."<ref name=":8" />
===Global Food Safety Initiative (GFSI)===
The [[wikipedia:Global Food Safety Initiative|GFSI]] is a collection of private organizations that have developed a set of benchmarking requirements for improving food safety management programs, with a goal of making them balanced enough to be broadly applicable while remaining relevant to different countries and regions of the world.<ref name="EagleFood19" /> Previously known as the GFSI Guidance Document<ref name="GFSIRelease17">{{cite web |url=https://mygfsi.com/press_releases/gfsi-releases-new-edition-of-benchmarking-requirements/ |title=GFSI Releases New Edition of Benchmarking Requirements |publisher=Global Food Safety Initiative |date=28 February 2017 |accessdate=10 November 2022}}</ref>, the GFSI Benchmarking Requirements act as a set of criteria and professional framework for food safety management programs to fulfill, formally allowing an organization to be recognized and certified by the GFSI. Certification to the GFSI Benchmarking Requirements "demonstrates an organization’s serious commitment to food safety to customers and potential customers across the world."<ref name="EagleFood19" /> An organization seeks out a third-party certification program owner (CPO) and undergoes the auditing process, which is driven and supported by the GFSI Benchmarking Requirements.<ref name="GFSICert22">{{cite web |url=https://mygfsi.com/how-to-implement/certification/ |title=Certification |publisher=Global Food Safety Initiative |date=2022 |accessdate=10 November 2022}}</ref> GFSI is also responsible for ensuring CPOs and certification bodies meet the necessary requirements.
 
===Hazard analysis and critical control points (HACCP)===
The [[wikipedia:Hazard analysis and critical control points|hazard analysis and critical control points]] or HACCP system has been adopted and integrated in various ways over the years<ref name="WeinrothHist18">{{Cite journal |last=Weinroth |first=Margaret D |last2=Belk |first2=Aeriel D |last3=Belk |first3=Keith E |date=2018-11-09 |title=History, development, and current status of food safety systems worldwide |url=https://academic.oup.com/af/article/8/4/9/5087923 |journal=Animal Frontiers |language=en |volume=8 |issue=4 |pages=9–15 |doi=10.1093/af/vfy016 |issn=2160-6056 |pmc=PMC6951898 |pmid=32002225}}</ref>, but at its core, the system directs organizations to focus on key areas or "critical control points" (CCPs) of vulnerability and hazard within the production process and mitigate their impact on overall food safety.<ref name="EagleFood19" /> Though the seeds of HACCP go back to the 1970s, it wasn't until the mid-1990s that it began finding its way into formal regulatory structures in the United States, first codified as 9 CFR Parts 304, 308, 310, 320, 327, 381, 416, and 417 in July 1996.<ref name="WeinrothHist18" /><ref name="61FR38806">{{cite web |url=https://www.govinfo.gov/app/details/FR-1996-07-25/96-17837/summary |title=61 FR 38806 - Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP) Systems |work=Federal Register |publisher=U.S. Government Publishing Office |date=25 July 1996 |accessdate=10 November 2022}}</ref> HACCP also found its way into other standards benchmarked by the GFSI.<ref name="WeinrothHist18" /> The concept of HACCP has perhaps changed slightly over the years, but the main principles remain<ref name="EagleFood19" />:
 
#Conduct a hazard analysis.
#Identify CCPs.
#Establish critical limits for those CCPs.
#Establish monitoring procedures for those CCPs.
#Establish corrective action for failed limits.
#Establish verification procedures.
#Establish record keeping and documentation procedures.
 
===International Featured Standards (IFS)===
The IFS is made up of a group of eight food and non-food standards, covering various processes along the food supply chain. IFS Management, who is responsible for the standards, notes that "IFS does not specify what these processes must look like but merely provides a risk-based assessment"<ref name="IFSHome">{{cite web |url=https://www.ifs-certification.com/index.php/en/ |title=IFS: Global Safety and Quality Standards |publisher=IFS Management GmbH |accessdate=10 November 2022}}</ref> or "uniform evaluation system"<ref name="EagleFood19" /> for them. Organizations such as food manufacturers and logistics providers can certify to the standards. Some of the more relevant to food and beverage laboratories include IFS Food (for food manufacturers), IFS Global Markets Food (for food retailers), IFS PACsecure 2 (for packaging manufactures), and IFS Global Markets PACsecure (for packaging suppliers).<ref name="IFSStandards">{{cite web |url=https://www.ifs-certification.com/index.php/en/standards |title=IFS Standards |publisher=IFS Management GmbH |accessdate=10 November 2022}}</ref>
 
===International Organization for Standardization (ISO) 22000===
The [[wikipedia:ISO 22000|ISO 22000]] series of standards addresses how a food safety management system should be set up and operated, and how organizations can be certified to the standard by a third-party auditor.<ref name="ISO22000">{{cite web |url=https://www.iso.org/iso-22000-food-safety-management.html |title=ISO 22000 Food safety management |publisher=International Organization for Standardization |accessdate=10 November 2022}}</ref> ISO 22000 is based off the [[ISO 9000]] family of [[quality management system]] standards and, like other standards, incorporates elements of HACCP.<ref name="WeinrothHist18" /> The standard claims to be advantaged compared to other standards due to its comprehensive applicability across an entire organization, and across the entire food chain.<ref name="ISO22000Home">{{cite web |url=https://committee.iso.org/home/tc34sc17 |title=ISO/TC34/SC17 |publisher=International Organization for Standardization |accessdate=10 November 2022}}</ref> Major standards applicable to manufacturers with laboratories include:
 
*ISO/TS 22002-1:2009 ''Prerequisite programmes on food safety — Part 1: Food manufacturing''<ref name="ISO22002-1">{{cite web |url=https://www.iso.org/standard/44001.html |title=ISO/TS 22002-1:2009 Prerequisite programmes on food safety — Part 1: Food manufacturing |publisher=International Organization for Standardization |date=December 2009 |accessdate=10 November 2022}}</ref>
*ISO/TS 22002-4:2013 ''Prerequisite programmes on food safety — Part 4: Food packaging manufacturing''<ref name="ISO22002-4">{{cite web |url=https://www.iso.org/standard/60969.html |title=ISO/TS 22002-4:2013 Prerequisite programmes on food safety — Part 4: Food packaging manufacturing |publisher=International Organization for Standardization |date=December 2013 |accessdate=10 November 2022}}</ref>
*ISO/TS 22002-6:2016 ''Prerequisite programmes on food safety — Part 6: Feed and animal food production''<ref name="ISO22002-6">{{cite web |url=https://www.iso.org/standard/66126.html |title=ISO/TS 22002-6:2016 Prerequisite programmes on food safety — Part 6: Feed and animal food production |publisher=International Organization for Standardization |date=April 2016 |accessdate=10 November 2022}}</ref>
 
===Safe Quality Food (SQF) Program===
The SQF Program, headlined by the SQF Institute and recognized by the GFSI, is a food "safety plus quality" management certification mechanism that covers the food supply chain from farm to fork.<ref name="EagleFood19" /> Those who wish to be certified to SQF must comply with SQF Code, which covers a variety of topics, from aquaculture and farming to food packaging and food and feed manufacturing.<ref name="SQFCode">{{cite web |url=https://www.sqfi.com/resource-center/sqf-code-edition-9-downloads/ |title=SQF Code – Edition 9 Downloads |publisher=SQF Institute |date=24 May 2021 |accessdate=10 November 2022}}</ref> Like other standards, the organization wanting to be accredited finds a certified third-party auditor to administer program certification.
 
 
==Regulations and laws around the world==
The safety and quality of food is a high priority for most countries around the world, though how that safety and quality is regulated and legislated varies, sometimes significantly. The following subsections briefly address the primary regulations and legislation enacted in seven major countries and supranational unions around the world. (It is beyond the scope of this FAQ to address them all.) Similarities among the countries may be seen in their goals, but it should be noted that differences—significant and nuanced—exist among them all in regards to regulatory approaches to sampling, testing, risk, and importing<ref name="BuzbyFood03">{{cite web |url=https://www.ers.usda.gov/amber-waves/2003/november/food-safety-and-trade-regulations-risks-and-reconciliation/ |title=Food Safety and Trade: Regulations, Risks, and Reconciliation |author=Buzby, J.C.; Mitchell, L. |work=Amber Waves |publisher=U.S. Department of Agriculture, Economic Research Service |date=01 November 2003 |accessdate=13 November 2022}}</ref><ref name="GAOFoodSafety05">{{cite web |url=https://www.gao.gov/products/gao-05-212 |title=Food Safety: Experiences of Seven Countries in Consolidating Their Food Safety Systems |author=U.S. Government Accountability Office |date=February 2005 |accessdate=13 November 2022}}</ref><ref name="WhitworthReport22">{{cite web |url=https://www.foodsafetynews.com/2022/02/report-finds-food-testing-policies-different-between-countries/ |title=Report finds food testing policies different between countries |author=Whitworth, J. |work=Food Safety News |date=22 February 2022 |accessdate=13 November 2022}}</ref>, which should not be surprising given the cultural, political, and functional differences across regions and nations of the world.<ref name="BuzbyFood03" />
 
===Food Safety Act 1990 and Food Standards Act 1999 - United Kingdom===
The [[wikipedia:Food Safety Act 1990|Food Safety Act of 1990]] and [[wikipedia:Food Standards Agency|Food Standards Act of 1999]] represent the core of food safety regulation in the United Kingdom, though there are other pieces of legislation that also have an impact.<ref name="SBCFood22">{{cite web |url=https://www.scarborough.gov.uk/home/business-licensing-and-grants/food-hygeine/food-safety-regulations |title=Food safety regulations |publisher=Scarborough Borough Council |date=10 November 2022 |accessdate=10 November 2022}}</ref><ref name="FSAKey22">{{cite web |url=https://www.food.gov.uk/about-us/key-regulations |title=Key regulations |publisher=Food Standards Agency |date=30 August 2022 |accessdate=10 November 2022}}</ref> The Food Safety Act of 1990 encourages entities to "not include anything in food, remove anything from food, or treat food in any way which means it would be damaging to the health of people eating it"; serve or sell food that is of a quality that "consumers would expect"; and ensure food is labeled, advertised, and presented clearly and truthfully.<ref name="SBCFood22" /><ref name="FSAKey22" /> The Food Standards Act of 1999 later created the UK's Food Standards Agency (FSA) "to protect public health from risks which may arise in connection with the consumption of food (including risks caused by the way in which it is produced or supplied) and otherwise to protect the interests of consumers in relation to food."<ref name="FSA99Sec1">{{cite web |url=https://www.legislation.gov.uk/ukpga/1999/28/section/1 |title=1999 c. 28, The Food Standards Agency, Section 1 |work=legislation.gov.uk |accessdate=10 November 2022}}</ref> One of the ways the FSA does this is through enforcing food safety regulation at the local level, including within food production facilities, as well as setting ingredient and nutrition labelling policy.<ref name="FSAAbout">{{cite web |url=https://www.gov.uk/government/organisations/food-standards-agency |title=Food Standards Agency |work=Gov.uk |accessdate=13 November 2022}}</ref> Regulations and guidance from the FSA address not only labelling but also radioactivity monitoring, meat processing, manure management, ''Salmonella'' testing, temperature control, dairy hygiene, and more.<ref name="FSAGuidReg">{{cite web |url=https://www.gov.uk/search/guidance-and-regulation?organisations%5B%5D=food-standards-agency&parent=food-standards-agency |title=Guidance and regulation: Food Standards Agency (FSA) |work=Gov.uk |accessdate=13 November 2022}}</ref>
 
===Food Safety and Standards Act of 2006 - India===
This act was enacted in 2006 to both consolidate existing food-related law and to establish the Food Safety and Standards Authority of India (FSSAI), which develops regulations and standards of practice for the manufacture, storage, distribution, and packaging of food.<ref name="PRSImplement">{{cite web |url=https://prsindia.org/policy/report-summaries/implementation-food-safety-and-standards-act-2006 |title=Implementation of Food Safety and Standards Act, 2006 |work=PRS Legislative Research |accessdate=13 November 2022}}</ref><ref name="FSSAIFood">{{cite web |url=https://fssai.gov.in/cms/food-safety-and-standards-act-2006.php |title=Food Safety and Standards Act, 2006 |publisher=Food Safety and Standards Authority of India |accessdate=13 November 2022}}</ref> However, an audit of FSSAI by the Comptroller and Auditor General of India (CAG) in December 2017 revealed some deficiencies in the FSSAI's activities, including an overall "low quality" of food testing laboratories in the country.<ref name="PRSImplement" /> Nonetheless, the FSSAI remains the primary regulatory watchdog, developing standards and guidelines for food and enforcing those standards. This includes setting limits for food additives, contaminants, pesticides, drugs, heavy metals, and more, as well as defining quality control mechanisms, accreditation requirements, sampling and analytical techniques, and more.<ref name="FSSAIFood" />
 
===Food Safety Law - China===
The [[wikipedia:Food safety in China|Food Safety Law]] is described as "the fundamental law regulating food safety in China."<ref name="UNEPFood15">{{cite web |url=https://leap.unep.org/countries/cn/national-legislation/food-safety-law-2015 |title=Food Safety Law (2015) |author=Food and Agriculture Organization of the United Nations |work=Law and Environment Assistance Platform |publisher=United Nations Environmental Programme |date=24 April 2015 |accessdate=13 November 2022}}</ref> Enacted in 2009 and revised in 2015, the Law "builds up the basic legal framework for food safety supervision and management" and  "introduces many new regulatory requirements," including "not only general requirements applicable to food and food additives, but also specific requirements for food-related products and other product categories."<ref name="UNEPFood15" /> Among these activities, the Law describes how food testing laboratories shall conduct their activities, from accreditation and sampling to testing and reporting.<ref name="USDAChina15">{{cite web |url=https://apps.fas.usda.gov/newgainapi/api/report/downloadreportbyfilename?filename=Amended%20Food%20Safety%20Law%20of%20China_Beijing_China%20-%20Peoples%20Republic%20of_5-18-2015.pdf |format=PDF |title=China's Food Safety Law (2015) |author=Foreign Agriculture Service Staff |publisher=U.S. Department of Agriculture |work=GAIN Repo |date=18 May 2015 |accessdate=13 November 2022}}</ref>
 
===Food Sanitation Act and Food Safety Basic Act - Japan===
The Food Sanitation Act of 1947 and the Food Safety Basic Act of 2003 represent the most important pieces of food-related legislation in Japan, though there are others. The Food Sanitation Act was originally enacted "to prevent sanitation hazards resulting from eating and drinking by enforcing regulations and other measures necessary from the viewpoint of public health, to ensure food safety and thereby to protect citizens' health."<ref name="JLTFood47">{{cite web |url=https://www.japaneselawtranslation.go.jp/en/laws/view/3687/en |title=Food Sanitation Act (Act No. 233 of 1947) |work=Japanese Law Translation |date=24 December 1947 |accessdate=13 November 2023}}</ref> The Food Safety Basic Act recognized the effects of "internationalization" and changing dietary habits, as well as scientific and technological shifts in food production, as a primary driver for modernizing food safety and sustainability in the country, and it also created the Food Safety Commission of Japan.<ref name="FSCFoodSafe03">{{cite web |url=https://www.fsc.go.jp/english/basic_act/fs_basic_act.pdf |format=PDF |title=Food Safety Basic Act |publisher=Food Safety Commission of Japan |date=23 May 2003 |accessdate=13 November 2022}}</ref> Between the two pieces of legislation, standards and specifications for food and food additives, as well as associated tools and packaging, are addressed, as are inspection standards, production standards, hygiene management, and individual food and ingredient safety.<ref name="BMFoodJapan18">{{cite web |url=https://resourcehub.bakermckenzie.com/en/resources/asia-pacific-food-law-guide/asia-pacific/japan/topics/food-product-and-safety-regulation |title=Japan: Food product and safety regulation |work=Asia Pacific Food Law Guide |author=Baker McKenzie |date=2018 |accessdate=13 November 2022}}</ref>
 
===Food Safety Modernization Act (FSMA) and other acts - United States===
The [[wikipedia:FDA Food Safety Modernization Act|Food Safety Modernization Act]] of the United States was signed into law in January 2011, giving the US Food and Drug Administration (FDA) more regulatory authority to address the way food is grown, harvested, and processed.<ref name="WeinrothHist18" /><ref name="FDAFood22">{{cite web |url=https://www.fda.gov/animal-veterinary/animal-food-feeds/food-safety-modernization-act-and-animal-food |title=Food Safety Modernization Act and Animal Food |publisher=U.S. Food and Drug Administration |date=20 October 2022 |accessdate=15 November 2022}}</ref> It has been described by the FDA as "the most sweeping reform of our food safety laws in more than 70 years."<ref name="FDAFood22" /> The FSMA, at its base, has five key aspects, addressing preventive controls, inspection and compliance, the safety of food imports, mandatory recall response, and food partnership enhancement.<ref name="FDAFood22" /> However, FSMA continues to evolve, with additional rules getting added since its enactment, including rules about record management, GMP for human food and animal feed, and laboratory accreditation (referred to as the [[LII:FDA Food Safety Modernization Act Final Rule on Laboratory Accreditation for Analyses of Foods: Considerations for Labs and Informatics Vendors|LAAF Rule]]).<ref name="FDAFSMA22">{{cite web |url=https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-rules-guidance-industry#rules |title=FSMA Rules & Guidance for Industry |publisher=U.S. Food and Drug Administration |date=20 October 2022 |accessdate=15 November 2022}}</ref>
 
Another important regulatory body in the US is the Food Safety and Inspection Service (FSIS), which is overseen by the US Department of Agriculture (USDA). The FSIS and its authority to regulate are derived from three different acts: the Federal Meat Inspection Act of 1906, the Poultry Products Inspection Act of 1957, and the Egg Products Inspection Act of 1970.<ref name="USDAOurHist18">{{cite web |url=https://www.fsis.usda.gov/about-fsis/history |title=Our History |author=Food Safety and Inspection Service |publisher=U.S. Department of Agriculture |date=21 February 2018 |accessdate=15 November 2022}}</ref> The FSIS has developed its own regulatory requirements for meat, poultry, and egg products, including for inspections, imports and exports, labeling, and laboratory testing.<ref name="9CFR412">{{cite web |url=https://www.ecfr.gov/current/title-9/chapter-III/subchapter-E/part-412 |title=9 CFR Part 412 - Label Approval |work=Code of Federal Regulations |date=31 October 2022 |accessdate=15 November 2022}}</ref><ref name="FSISFedReg">{{cite web |url=https://www.fsis.usda.gov/policy/federal-register-rulemaking/federal-register-rules |title=Federal Register Rules |publisher=Food Safety and Inspection Service |accessdate=15 November 2022}}</ref>
 
===General Food Law Regulation (GFLR) - European Union===
The GFLR was enacted across the European Union in 2002 as part of Regulation (EC) No 178/2002, and it is described as "the foundation of food and feed law" for the EU.<ref name="EUGeneral">{{cite web |url=https://food.ec.europa.eu/horizontal-topics/general-food-law_en |title=General Food Law |work=Food Safety |publisher=European Commission |accessdate=14 November 2022}}</ref> Along with setting requirements and procedures for food and feed safety, the GFLR also mandated the creation of the European Food Safety Authority (EFSA), an independent body assigned to developing sound scientific advice about and providing support towards the goals of food, beverage, and feed safety in the EU.<ref name="WeinrothHist18" /><ref name="EUGeneral" /> As such, the EFSA develops broad and sector-specific guidance<ref name="EFSAGuidance">{{cite web |url=https://www.efsa.europa.eu/en/methodology/guidance |title=Guidance and other assessment methodology documents |publisher=European Food Safety Authority |accessdate=14 November 2022}}</ref>, as well as other rules related to scientific assessment of food safety matters, e.g., Regulation (EC) No 2073/2005 on microbiological criteria for foodstuffs.<ref name="EU2073-2005">{{cite web |url=https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX%3A32005R2073 |title=Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs |work=EUR-Lex |date=03 August 2020 |accessdate=15 November 2022}}</ref> The EFSA also develop food classification standardization tools such as the Standard Sample Description (SSD2) data model, to better ensure an appropriate "format for describing food and feed samples and analytical results that is used by EFSA’s data providers."<ref name="EFSAFoodClass">{{cite web |url=https://www.efsa.europa.eu/en/data/data-standardisation |title=Food classification standardisation – The FoodEx2 system |publisher=European Food Safety Authority |accessdate=14 November 2022}}</ref>
 
===Safe Food for Canadians Act (SFCA) - Canada===
In November 2012, the SFCA was enacted to place regulatory "focus on prevention to ensure a food that is imported, exported or shipped from one province to another, is manufactured, stored, packaged and labelled in a way that does not present a risk of contamination."<ref name="ManitobaSafe">{{cite web |url=https://www.gov.mb.ca/agriculture/food-safety/at-the-food-processor/safe-food-for-canadians-act.html |title=Safe Food for Canadians Act |publisher=Manitoba Government |accessdate=15 November 2022}}</ref><ref name="JLWSafeFood19">{{cite web |url=https://laws-lois.justice.gc.ca/eng/acts/s-1.1/index.html |title=Safe Food for Canadians Act (S.C. 2012, c. 24) |work=Justice Laws Website |publisher=Government of Canada |date=17 June 2019 |accessdate=15 November 2022}}</ref> Though Canadian Food Inspection Agency (CFIA) enforcement of the SFCA's regulations didn't start until January 2019<ref name="ManitobaSafe" />, the consolidation of 14 sets of existing food regulations by the SFCA has managed to improve consistency, reduce administrative burden, and enable food business innovation.<ref name="GoCUnder18">{{cite book |last=Canadian Food Inspection Agency |year=2018 |title=Understanding the Safe Food for Canadians Regulations: A handbook for food businesses |url=https://inspection.canada.ca/food-safety-for-industry/toolkit-for-food-businesses/sfcr-handbook-for-food-businesses/eng/1481560206153/1481560532540?chap=0 |publisher=Government of Canada |isbn=9780660269856}}</ref> An interpretive guide published by the CFIA, ''Understanding the Safe Food for Canadians Regulations: A handbook for food businesses'', summarizes and explains some of the nuances of the SFCA and its 16 parts on matters such as trade, licensing, preventive controls, packaging and labeling, and traceability.<ref name="GoCUnder18" />
 
==Other influencing factors==
===Good manufacturing practice (GMP) and current good manufacturing practice (cGMP)===
As a broad concept, [[good manufacturing practice]] or GMP is an organized set of standards and guidelines that allow manufacturers of most any product to better ensure their products are consistently produced and packaged to a consistent level of quality. GMP tends to cover most every step of production, from planning development and choosing starting materials to training personnel and documenting processes.<ref name="ISPEGMP">{{cite web |url=https://ispe.org/initiatives/regulatory-resources/gmp |title=Good Manufacturing Practice (GMP) Resources |publisher=International Society for Pharmaceutical Engineering, Inc |accessdate=15 November 2022}}</ref> The concept of GMP is often spoken of in terms of pharmaceutical and medical device manufacturing<ref name="ISPEGMP" /><ref name="WHOMedicines15">{{cite web |url=https://www.who.int/news-room/questions-and-answers/item/medicines-good-manufacturing-processes |title=Medicines: Good manufacturing practices |publisher=World Health Organization |date=20 November 2015 |accessdate=15 November 2022}}</ref>, though it is applicable to most any other production industry<ref name="CEReg07">{{cite web |url=https://www.controleng.com/articles/regulated-or-not-know-good-manufacturing-practices-gmp/ |title=Regulated or not? Know good manufacturing practices (GMP) |author=''Control Engineering'' Staff |work=Control Engineering |date=14 July 2007 |accessdate=15 November 2022}}</ref><ref name="FDAGMPCosm22">{{cite web |url=https://www.fda.gov/cosmetics/cosmetics-guidance-documents/good-manufacturing-practice-gmp-guidelinesinspection-checklist-cosmetics |title=Good Manufacturing Practice (GMP) Guidelines/Inspection Checklist for Cosmetics |publisher=U.S. Food and Drug Administration |date=25 February 2022 |accessdate=15 November 2022}}</ref>, including the food and beverage industry.<ref name="FDAGoodMan17">{{cite web |url=https://www.who.int/news-room/questions-and-answers/item/medicines-good-manufacturing-processes |title=Good Manufacturing Practices for the 21st Century for Food Processing (2004 Study) Section 1: Current Food Good Manufacturing Practices |publisher=U.S. Food and Drug Administration |date=27 December 2017}}</ref><ref>{{Cite book |last=Manning |date=2013-01-11 |title=Food & Drink - Good Manufacturing Practice: A Guide to its Responsible Management |url=http://doi.wiley.com/10.1002/9781118318225 |language=en |publisher=Wiley-Blackwell |place=Oxford, UK |doi=10.1002/9781118318225 |isbn=978-1-118-31822-5}}</ref>
 
Closely related is the term "current good manufacturing practice" or cGMP. Both "GMP" and "cGMP" are largely interchangeable, though the latter is preferred in most regulatory language of the United States. A more nuanced take says that cGMP essentially represents the newest, most updated technologies implemented towards the goals of meeting GMP requirements.<ref name="PSDiff21">{{cite web |url=https://www.pharmaspecialists.com/2021/10/difference-between-gmp-and-cgmp.html#gsc.tab=0 |title=Difference Between GMP and cGMP |work=Pharma Specialists |date=13 October 2021 |accessdate=15 November 2022}}</ref><ref name="MoravekTheDiff">{{cite web |url=https://www.moravek.com/the-differences-between-gmp-and-cgmp/ |title=The Differences Between GMP and cGMP |work=Moravek Blog |publisher=Moravek, Inc |date=January 2021 |accessdate=15 November 2022}}</ref> In the United States, cGMP—in the context of food—was first introduced in 1969 as 21 CFR Part 110, though the concept of cGMP was modernized in 2015, in 21 CFR Part 117. This led to not only broad food- and beverage-based cGMPs but also cGMPs specific to a type of ingestible, including dietary supplements, infant formula, low-acid canned food, and bottled water.<ref name="FDACurrentGood20">{{cite web |url=https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/current-good-manufacturing-practices-cgmps-food-and-dietary-supplements |title=Current Good Manufacturing Practices (CGMPs) for Food and Dietary Supplements |publisher=U.S. Food and Drug Administration |date=31 January 2020 |accessdate=15 November 2022}}</ref>
 
 
==Conclusion==
This brief topical article sought to answer "what standards and regulations affect a food and beverage laboratory?" It notes that


==References==
==References==
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[[Category:Food and beverage industry|LIMS FAQ:What standards and regulations affect a food and beverage laboratory?]]
[[Category:LIMS FAQ articles (added in 2022)]]
[[Category:LIMS FAQ articles (all)]]
[[Category:LIMS FAQ articles on food and beverage]]

Latest revision as of 19:33, 17 February 2023

Sandbox begins below

  • Discussion and practical use of artificial intelligence (AI) in the laboratory is, perhaps to the surprise of some, not a recent phenomena. In the mid-1980s, researchers were developing computerized AI systems able "to develop automatic decision rules for follow-up analysis of [clinical laboratory] tests depending on prior information, thus avoiding the delays of traditional sequential testing and the costs of unnecessary parallel testing."[1] In fact, discussion of AI in general was ongoing even in the mid-1950s.[2][3]
  • Hiring demand for laboratorians with AI experience (2015–18) has historically been higher in non-healthcare industries, such as manufacturing, mining, and agriculture, shedding a light on how AI adoption in the clinical setting may be lacking. According to the Brookings Institute, "Even for the relatively-skilled job postings in hospitals, which includes doctors, nurses, medical technicians, research lab workers, and managers, only approximately 1 in 1,250 job postings required AI skills." They add: "AI adoption may be slow because it is not yet useful, or because it may not end up being as useful as we hope. While our view is that AI has great potential in health care, it is still an open question."[4]
  • Today, AI is being practically used in not only clinical diagnostic laboratories but also clinical research labs, life science labs, and research and development (R&D) labs, and more. Practical uses of AI can be found in:
clinical research labs[5]
hospitals[5][6]
medical diagnostics labs[6][7][8][9][10][11]
chromatography labs[11]
biology and life science labs[12]
medical imaging centers[13]
ophthalmology clinics[14]
reproduction clinics[15][16][17]
digital pathology labs[18]
material testing labs[19][20][21]
chemical experimentation and molecular discovery labs[21][22][23]
quantum physics labs[24]
  • What's going on in these labs?
Materials science: The creation of "a modular robotic platform driven by a model-based optimization algorithm capable of autonomously optimizing the optical and electronic properties of thin-film materials by modifying the film composition and processing conditions ..."[19]
Materials science: "Most of the applications of [machine learning (ML)] in chemical and materials sciences, as we have said, feature supervised learning algorithms. The goal there is to supplement or replace traditional modeling methods, at the quantum chemical or classical level, in order to predict the properties of molecules or materials directly from their structure or their chemical composition ... Our research group was applying the same idea on a narrower range of materials, trying to confirm that for a given chemical composition, geometrical descriptors of a material’s structure could lead to accurate predictions of its mechanical features."[20]
Life science: "In biological experiments, we generally cannot as easily declare victory, but we can use the systems biology approach of cycling between experimentation and modelling to see which sequences, when tested, are most likely to improve the model. In artificial intelligence, this is called active learning, and it has some similarity to the way in which we as humans learn as infants: we get some help from parents and teachers, but mainly model the world around us by exploring it and interacting with it. Ideally then, we would recreate such an environment for our machine learning algorithms in the laboratory, where we start with an initial ‘infant’ model of a certain regulatory system or protein function and let the computer decide what sequence designs to try out – a deep learning version of the ‘robot scientist’. Microbes are ideal organisms for such an approach, given the ease and speed with which they can be grown and genetically manipulated. Combined with laboratory automation, many microbial experiments can (soon) be performed with minimal human intervention, ranging from strain construction and screening, such as operated by Amyris, Gingko, Transcriptic, etc., to full-genome engineering or even the design of microbial ecologies."[12]
Digital pathology: "The collaboration combines two AI solutions, VistaPath’s Sentinel, the world’s first automated tissue grossing platform, and Gestalt’s AI Requisition Engine (AIRE), a leading-edge AI algorithm for accessioning, to raise the bar in AI-driven pathology digitization. Designed to make tissue grossing faster and more accurate, VistaPath’s Sentinel uses a high-quality video system to assess specimens and create a gross report 93% faster than human technicians with 43% more accuracy. It not only improves on quality by continuously monitoring the cassette, container, and tissue to reduce mislabeling and specimen mix-up, but also increases traceability by retaining original images for downstream review."[25]
Chemistry and molecular science: "The benefits of combining automated experimentation with a layer of artificial intelligence (AI) have been demonstrated for flow reactors, photovoltaic films, organic synthesis, perovskites and in formulation problems. However, so far no approaches have integrated mobile robotics with AI for chemical experiments. Here, we built Bayesian optimization into a mobile robotic workflow to conduct photocatalysis experiments within a ten-dimensional space."[22]
Chemistry and immunology: "Chemistry and immunology laboratories are particularly well-suited to leverage machine learning because they generate large, highly structured data sets, Schulz and others wrote in a separate review paper. Labor-intensive processes used for interpretation and quality control of electrophoresis traces and mass spectra could benefit from automation as the technology improves, they said. Clinical chemistry laboratories also generate digital images—such as urine sediment analysis—that may be highly conducive to semiautomated analyses, given advances in computer vision, the paper noted."[26]
Clinical research: "... retrospective analysis of existing patient data for descriptive and clustering purposes [and] automation of knowledge extraction, ranging from text mining, patient selection for trials, to generation of new research hypotheses ..."[5]
Clinical research: "AI ... offers a further layer to the laboratory system by analyzing all experimental data collected by experiment devices, whether it be a sensor or a collaborative robot. From data collected, AI is able to produce hypotheses and predict which combination of materials or temperature is desired for the experiment. In short, this system will allow scientists to be aided by a highly intelligent system which is constantly monitoring and analyzing the experimental output. In this way, AI will help an experiment from its inception to conclusion."[27]
Clinical research/medical diagnostics: "Artificial intelligence (AI) in the laboratory is primarily used to make sense of big data, the almost impossibly large sets of data that biologists and pharmaceutical R&D teams are accustomed to working with. AI algorithms can parse large amounts of data in a short amount of time and turn that data into visualizations that viewers can easily understand. In certain data-intensive fields, such as genomic testing and virus research, AI algorithms are the best way to sort through the data and do some of the pattern recognition work."[28]
Medical diagnostics: Development and implementation of clinical decision support systems [5][6]
Medical diagnostics: "Finally, in the laboratory, AI reduces the number of unnecessary blood samples when diagnosing infection. Instead of the 'gold standard blood sample' that takes 24-72 hours, the algorithm can predict the outcome of the blood sample with almost 80% accuracy based on demographics, vital signs, medications, and laboratory and radiology results. These are all examples of how Artificial Intelligence can be used to test better and faster with information that already exists. This saves time and costs."[10]
Medical diagnostics: "Chang sees two overarching classes of AI models: those that tackle internal challenges in the lab, such as how to deliver more accurate results to clinicians; and those that seek to identify cohorts of patients and care processes to close quality gaps in health delivery systems. The lab, however, 'isn’t truly an island,' said Michelle Stoffel, MD, PhD, associate chief medical information officer for laboratory medicine and pathology at M Health Fairview and the University of Minnesota in Minneapolis. 'When other healthcare professionals are working with electronic health records or other applications, there could be AI-driven tools, or algorithms used by an institution’s systems that may draw on laboratory data.'"[26]
Medical diagnostics: AI is used for the formulation of reference ranges, improvement of quality control, and automated interpretation of results. "Continuous monitoring of specimen acceptability, collection and transport can result in the prompt identification and correction of problems, leading to improved patient care and a reduction in unnecessary redraws and delays in reporting results."[8]
Reproduction science: "The field of AI is the marriage of humans and computers while reproductive medicine combines clinical medicine and the scientific laboratory of embryology. The application of AI has the potential to disconnect healthcare professionals from patients through algorithms, automated communication, and clinical imaging. However, in the embryology laboratory, AI, with its focus on gametes and embryos, can avoid the same risk of distancing from the patient. Areas of application of AI in the laboratory would be to enhance and automate embryo ranking through analysis of images, the ultimate goal being to predict successful implantation. Might such a trend obviate the need for embryo morphological assessment, time-lapse imaging and preimplantation genetic testing for aneuploidy (PGT-A), including mosaicism. Additionally, AI could assist with automation through analysis of testicular sperm samples searching for viable gametes, embryo grading uniformity."[15]
Chromatography-heavy sciences: " A great example of this is AI in the Liquid Chromatography Mass Spectrometry (LC-MS) field. LC-MS is a great tool used to measure various compounds in the human body, including everything from hormone levels to trace metals. One of the ways AI has already integrated with LC-MS is how it cuts down on the rate limiting steps of LC-MS, which more often than not are sample prep and LC separations. One system that Physicians Lab has made use of is parallel processing using SCIEX MPX 2.0 High Throughput System. This system can couple parallel runs with one LCMS instrument, resulting in twice the speed with no loss to accuracy. It can do this by staggering two runs either using the same method, or different methods entirely. What really makes this system great is its ability to automatically detect carryover and inject solvent blanks to clean the instrument. The system will then continue its analyzing, while automatically reinjecting samples that may be affected by the carryover. It will also flag high concentration without user input, allowing for easy detection of possibly faulty samples. This allows it to operate without users from startup to shut down. Some of the other ways that it can be used to increase efficiency are by using integrated network features to work on anything from streamlining management to increased throughput."[11]
Most any lab: "Predictive analytics, for example, is one tool that the Pistoia Alliance is using to better understand laboratory instruments and how they might fail over time... With the right data management strategies and careful consideration of metadata, how to best store data so that it can be used in future AI and ML workflows is essential to the pursuit of AI in the laboratory. Utilizing technologies such as LIMS and ELN enables lab users to catalogue data, providing context and instrument parameters that can then be fed into AI or ML systems. Without the correct data or with mismatched data types, AI and ML will not be possible, or at the very least, could provide undue bias trying to compare data from disparate sources."[29]
Most any lab: "When the actionable items are automatically created by Optima, the 'engine' starts working. An extremely sophisticated algorithm is able to assign the tasks to the resources, both laboratory personnel and instruments, according to the system configuration. Optima, thanks to a large amount of time dedicated to research the best way to automate this critical process, is able to automate most of the lab resource scheduling."[30]
  • A number of challenges exist in the realm of effectively and securely implementing AI in the laboratory. This includes:
Ethical and privacy challenges[5][26][31]
Algorithmic limitations[4]
Data access limitations, including "where to get it, how to share it, and how to know when you have enough to train a machine-learning system that will produce good results"[4][26][32][33]
Data integration and transformation issues[5][33]
Regulatory barriers[4][7]
Misaligned incentives[4]
Lack of knowledgeable/skilled talent[5][26][32][33]
Cost of skilled talent and infrastructure for maintaining and updating AI systems[26]
Legacy systems running outdated technologies[32]
Lack of IT systems or specialized software systems[33]
Lack of standardized, best practices-based methods of validating algorithms[26]
Failure to demonstrate real-world performance[7]
Failure to meet the needs of the professionals using it[7]
  • Given those challenges, some considerations should be made about implementing AI-based components in the laboratory. Examples include:
Clinical diagnostics: "From an industry and regulatory perspective, however, only the intended uses supported from the media manufacturer can be supported from AI applications, unless otherwise justified and substantive evidence is presented for additional claims support. This means strict adherence to specimen type and incubation conditions. Considering that the media was initially developed for human assessment using the well-trained microbiologist eye, and not an advanced imaging system with or without AI, this paradigm should shift to allow advancements in technology to challenge the status-quo of decreasing media read-times especially, as decreased read-times assist with laboratory turnaround times and thus patient management. Perhaps with an increasing body of evidence to support any proposed indications for use, either regulatory positions should be challenged, or manufacturers of media and industry AI-development specialists should work together to advance the field with new indications for use.
While the use of AI in the laboratory setting can be highly beneficial there are still some issues to be addressed. The first being phenotypically distinct single organism polymorphisms that may be interpreted by AI as separate organisms, as may also be the case for a human assessment, as well as small colony variant categorization. As detailed earlier, the broader the inputs, the greater the generalization of the model, and the higher the likelihood of algorithm accuracy. In that respect, understanding and planning around these design constraints is critical for ultimate deployment of algorithms. Additionally, expecting an AI system to correctly categorize “contamination” is a difficult task as often this again seemingly innocuous decision is dependent on years of experience and understanding the specimen type and the full clinical picture with detailed clinical histories. In this respect, a fully integrated AI-LIS system where all data is available may assist, but it is currently not possible to gather this granular detail needed to make this assessment reliable."[9]
Clinical diagnostics and pathology: "Well, if I’ve learned anything in my research into this topic, it’s that AI implementation needs to be a two-way street. First, any company who is active in this space must reach out to pathologists and laboratory medicine professionals to understand their daily workflows, needs, and pain points in as much detail as possible. Second, pathologists, laboratory medicine professionals, and educators must all play their important part – willingly offering their time and expertise when it is sought or proactively getting involved. And finally, it’s clear that there is an imbalanced focus on certain issues – with privacy, respect, and sustainability falling by the wayside."[31]
Healthcare: "While we are encouraged by the promise shown by AI in healthcare, and more broadly welcome the use of digital technologies in improving clinical outcomes and health system productivity, we also recognize that caution must be exercised when introducing any new healthcare technology. Working with colleagues across the NHS Transformation Directorate, as well as the wider AI community, we have been developing a framework to evaluate AI-enabled solutions in the health and care policy context. The aim of the framework is several-fold but is, at its core, a tool with which to highlight to healthcare commissioners, end users, patients and members of the public the considerations to be mindful when introducing AI to healthcare settings."[34]
Most any lab: A code of AI ethics should address objectivity, privacy, transparency, accountability, and sustainability in any AI implementation.[31]
Most any lab: "Another approach is to implement an AI program alongside a manual process, assessing its performance along the way, as a means to ease into using the program. 'I think one of the most impactful things that laboratorians can do today is to help make sure that the lab data that they’re generating is as robust as possible, because these AI tools rely on new training sets, and their performance is really only going to be as good as the training data sets they’re given,' Stoffel said."[26]

References

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  9. 9.0 9.1 DeYoung, B.; Morales, M.; Giglio, S. (4 August 2022). "Microbiology 2.0–A “behind the scenes” consideration for artificial intelligence applications for interpretive culture plate reading in routine diagnostic laboratories". Frontiers in Microbiology 13: 976068. doi:10.3389/fmicb.2022.976068. ISSN 1664-302X. PMC PMC9386241. PMID 35992715. https://www.frontiersin.org/articles/10.3389/fmicb.2022.976068/full. 
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  14. He, Mingguang; Li, Zhixi; Liu, Chi; Shi, Danli; Tan, Zachary (1 July 2020). "Deployment of Artificial Intelligence in Real-World Practice: Opportunity and Challenge" (in en). Asia-Pacific Journal of Ophthalmology 9 (4): 299–307. doi:10.1097/APO.0000000000000301. ISSN 2162-0989. https://journals.lww.com/10.1097/APO.0000000000000301. 
  15. 15.0 15.1 Trolice, Mark P.; Curchoe, Carol; Quaas, Alexander M (1 July 2021). "Artificial intelligence—the future is now" (in en). Journal of Assisted Reproduction and Genetics 38 (7): 1607–1612. doi:10.1007/s10815-021-02272-4. ISSN 1058-0468. PMC PMC8260235. PMID 34231110. https://link.springer.com/10.1007/s10815-021-02272-4. 
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