Difference between revisions of "User:Shawndouglas/sandbox/sublevel10"

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| type      = notice
| type      = notice
| style    = width: 960px;
| style    = width: 960px;
| text      = This is sublevel2 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>
| text      = This is sublevel10 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>
}}
}}


==Sandbox begins below==
==Sandbox begins below==
==1. Introduction to materials and materials testing laboratories==


<div align="center">-----Return to [[LII:The Comprehensive Guide to Physician Office Laboratory Setup and Operation|the beginning]] of this guide-----</div>
What is a material? This question is surprisingly more complex for the layperson than may be expected. The definition of "material" has varied significantly over the years, dependent on the course of study, laboratory, author, etc. A 1974 definition by Richardson and Peterson that has seen some use in academic study defines a material as "any nonliving matter of academic, engineering, or commercial importance."<ref>{{Cite book |last=Richardson |first=James H. |last2=Peterson |first2=Ronald V. |date= |year=1974 |title=Systematic Materials Analysis, Part 1 |url=https://books.google.com/books?id=BNocpYI8gJkC&printsec=frontcover&dq=Systematic+Materials+analysis&hl=en&newbks=1&newbks_redir=0&sa=X&ved=2ahUKEwjB1OeQx-aAAxWnmmoFHSV2BSsQ6AF6BAgMEAI#v=onepage&q=Systematic%20Materials%20analysis&f=false |chapter=Chapter 1: Introduction to Analytical Methods |series=Materials science series |publisher=Academic Press |place=New York |page=2 |isbn=978-0-12-587801-2 |doi=10.1016/B978-0-12-587801-2.X5001-0}}</ref> But recently biomaterials like biopolymers (as replacements for plastics)<ref>{{Cite journal |last=Das |first=Abinash |last2=Ringu |first2=Togam |last3=Ghosh |first3=Sampad |last4=Pramanik |first4=Nabakumar |date=2023-07 |title=A comprehensive review on recent advances in preparation, physicochemical characterization, and bioengineering applications of biopolymers |url=https://link.springer.com/10.1007/s00289-022-04443-4 |journal=Polymer Bulletin |language=en |volume=80 |issue=7 |pages=7247–7312 |doi=10.1007/s00289-022-04443-4 |issn=0170-0839 |pmc=PMC9409625 |pmid=36043186}}</ref> and even natural<ref>{{Cite journal |last=Kurniawan |first=Nicholas A. |last2=Bouten |first2=Carlijn V.C. |date=2018-04 |title=Mechanobiology of the cell–matrix interplay: Catching a glimpse of complexity via minimalistic models |url=https://linkinghub.elsevier.com/retrieve/pii/S2352431617301864 |journal=Extreme Mechanics Letters |language=en |volume=20 |pages=59–64 |doi=10.1016/j.eml.2018.01.004}}</ref> and engineered biological tissues<ref>{{Cite journal |last=Kim |first=Hyun S. |last2=Kumbar |first2=Sangamesh G. |last3=Nukavarapu |first3=Syam P. |date=2021-03 |title=Biomaterial-directed cell behavior for tissue engineering |url=https://linkinghub.elsevier.com/retrieve/pii/S246845112030057X |journal=Current Opinion in Biomedical Engineering |language=en |volume=17 |pages=100260 |doi=10.1016/j.cobme.2020.100260 |pmc=PMC7839921 |pmid=33521410}}</ref> may be referenced as "materials." (And to Richardson and Peterson's credit, they do add in the preface of their 1974 work that "[a]lthough the volumes are directed toward the physical sciences, they can also be of value for the biological scientist with materials problems."<ref>{{Cite book |last=Richardson |first=James H. |last2=Peterson |first2=Ronald V. |date= |year=1974 |title=Systematic Materials Analysis, Part 1 |url=https://books.google.com/books?id=BNocpYI8gJkC&printsec=frontcover&dq=Systematic+Materials+analysis&hl=en&newbks=1&newbks_redir=0&sa=X&ved=2ahUKEwjB1OeQx-aAAxWnmmoFHSV2BSsQ6AF6BAgMEAI#v=onepage&q=Systematic%20Materials%20analysis&f=false |chapter=Preface |series=Materials science series |publisher=Academic Press |place=New York |page=xiii |isbn=978-0-12-587801-2 |doi=10.1016/B978-0-12-587801-2.X5001-0}}</ref> A modern example would be biodegradable materials research for tissue and medical implant engineering.<ref>{{Cite journal |last=Modrák |first=Marcel |last2=Trebuňová |first2=Marianna |last3=Balogová |first3=Alena Findrik |last4=Hudák |first4=Radovan |last5=Živčák |first5=Jozef |date=2023-03-16 |title=Biodegradable Materials for Tissue Engineering: Development, Classification and Current Applications |url=https://www.mdpi.com/2079-4983/14/3/159 |journal=Journal of Functional Biomaterials |language=en |volume=14 |issue=3 |pages=159 |doi=10.3390/jfb14030159 |issn=2079-4983 |pmc=PMC10051288 |pmid=36976083}}</ref>) Yet today more questions arise. what of matter that doesn't have "academic, engineering, or commercial importance"; can it now be called a "material" in 2023? What if a particular matter exists today but hasn't been thoroughly studied to determine its value to researchers and industrialists? Indeed, the definition of "material" today is no easy task. This isn't made easier when even modern textbooks introduce the topic of materials science without aptly defining what a material actually is<ref>{{Cite book |last=Callister |first=William D. |last2=Rethwisch |first2=David G. |date= |year=2021 |title=Fundamentals of materials science and engineering: An integrated approach |url=https://books.google.com/books?id=NC09EAAAQBAJ&newbks=1&newbks_redir=0&printsec=frontcover |chapter=Chapter 1. Introduction |publisher=Wiley |place=Hoboken |pages=2–18 |isbn=978-1-119-74773-4}}</ref>, let alone what materials science is.<ref>{{Cite book |last=Sutton |first=Adrian P. |date=2021 |title=Concepts of materials science |edition=First edition |publisher=Oxford University Oress |place=Oxford [England] ; New York, NY |isbn=978-0-19-284683-9}}</ref> Perhaps the writers of said textbooks assume that the definitions of "material" and "materials science" have a "well duh" response.
<div class="nonumtoc">__TOC__</div>


==6. Final thoughts and additional resources==
To complicate things further, a material can be defined based upon the context of use. Take for example the ISO 10303-45 standard by the [[International Organization for Standardization]] (ISO), which addresses the representation and exchange of material and product manufacturing information in a standardized way, specifically describing how material and other engineering properties can be described in the model/framework.<ref name="ISO10303-45">{{cite web |url=https://www.iso.org/standard/78581.html |title=ISO 10303-45:2019 ''Industrial automation systems and integration — Product data representation and exchange — Part 45: Integrated generic resource: Material and other engineering properties'' |publisher=International Organization for Standardization |date=November 2019 |accessdate=20 September 2023}}</ref><ref name=":0">{{Cite journal |last=Swindells |first=Norman |date=2009 |title=The Representation and Exchange of Material and Other Engineering Properties |url=http://datascience.codata.org/articles/abstract/10.2481/dsj.008-007/ |journal=Data Science Journal |language=en |volume=8 |pages=190–200 |doi=10.2481/dsj.008-007 |issn=1683-1470}}</ref> The context here is "standardized data transfer of material- and product-related data," which in turn involves [[Ontology (information science)|ontologies]] that limit the complexity of materials science discourse and help better organize materials and product data into information and knowledge. As such, the ISO 10303 set of standards must define "material," and 10303-45 complicates matters further in this regard (though it will be helpful for this guide in the end).
===6.1 Final thoughts===


In reviewing ISO 10303-45 in 2009, Swindells notes the following about the standard<ref name=":0" />:


<blockquote>The first edition of ISO 10303-45 was derived from experience of the testing of, so-called, "materials" properties, and the terminology used in the standard reflects this experience. However, the information modelling of an engineering material, such as alloyed steel or high density polyethylene, is no different from the information modelling of a "product." The "material" properties are therefore one of the characteristics of a product, just as its shape and other characteristics are. Therefore all "materials" are products, and the information model in ISO 10303-45 can be used for any property of any product.</blockquote>


Put in other words, for the purposes of defining "material" for a broader, more standardized ontology, materials and products can be viewed as interchangeable. Mies puts this another way, stating that based on ISO 10303-45, a material can be defined as "a manufactured object with associated properties in the context of its use environment."<ref>{{Cite book |last=Mies, D. |date=2002 |editor-last=Kutz |editor-first=Myer |title=Handbook of materials selection |url=https://books.google.com/books?id=gWg-rchM700C&pg=PA499 |chapter=Chapter 17. Managing Materials Data |publisher=J. Wiley |place=New York |page=499 |isbn=978-0-471-35924-1}}</ref> But this representation only causes more confusion as we ask "does a material have to be manufactured?" After all, we have the term "raw material," which the Oxford English Dictionary defines as "the basic material from which a product is manufactured or made; unprocessed material."<ref name="OEDRawMat">{{cite web |url=https://www.oed.com/search/dictionary/?scope=Entries&q=raw+material |title=raw material |work=Oxford English Dictionary |accessdate=20 September 2023}}</ref> Additionally, chemical elements are defined as "the fundamental materials of which all matter is composed."<ref>{{Cite web |last=Lagowski, J.J.; Mason, B.H.; Tayler, R.J. |date=16 August 2023 |title=chemical element |work=Encyclopedia Britannica |url=https://www.britannica.com/science/chemical-element |accessdate=20 September 2023}}</ref> Taking into account the works of Richardson and Peterson, Mies, and Swindells, as well as ISO 10303-45, the concepts of "raw materials" and "chemical elements," and modern trends towards the inclusion of biomaterials (though discussion of biomaterials will be limited here) in materials science, we can land on the following definition for the purposes of this guide:


:A material is discrete matter that is elementally raw (e.g., native metallic and non-metallic elements), fundamentally processed (e.g., calcium oxide), or fully manufactured (by human, automation, or both; e.g., a fastener) that has an inherent set of properties that a human or automation-driven solution (e.g., an [[artificial intelligence]] [AI] algorithm) has identified for a potential or realized use environment.


===6.2 Further reading===
First, this definition more clearly defines the types of matter that can be included, recognizing that manufactured products may still be considered materials. Initially this may seem troublesome, however, in the scope of complex manufactured products such as automobiles and satellites; is anyone really referring to those types of products as "materials"? As such, the word "discrete" is included, which in manufacturing parlance refers to distinct components such as brackets and microchips that can be assembled into a greater, more complex finished product. This means that while both a bolt and an automobile are manufactured "products," the bolt, as a discrete type of matter, can be justified as a material, whereas the automobile can't. Second—answering the question of "what if a particular matter exists today but hasn't been thoroughly studied to determine its value to researchers and industrialists?"—the definition recognizes that the material needs at a minimum recognition of a potential use case. This turns out to be OK, because if no use case has been identified, the matter still can be classified as an element, compound, or substance. It also insinuates that that element, compound, or substance with no use case isn't going to be used in the manufacturing of any material or product. Third, the definition also recognizes the recent phenomena of autonomous systems discovering new materials and whether or not those autonomous systems should be credited with inventorship.<ref>{{Cite journal |last=Ishizuki |first=Naoya |last2=Shimizu |first2=Ryota |last3=Hitosugi |first3=Taro |date=2023-12-31 |title=Autonomous experimental systems in materials science |url=https://www.tandfonline.com/doi/full/10.1080/27660400.2023.2197519 |journal=Science and Technology of Advanced Materials: Methods |language=en |volume=3 |issue=1 |pages=2197519 |doi=10.1080/27660400.2023.2197519 |issn=2766-0400}}</ref> The question of inventorship is certainly worth discussion, though it is beyond the scope of this guide. Regardless, the use of automated systems to match a set of properties of a particular matter to a real-world use case isn't likely to go away, and this definition accepts that likelihood.
<br />
'''Clinical laboratories, including the POL'''


* {{cite book |url=https://www.aafp.org/family-physician/practice-and-career/managing-your-practice/pt-lab-testing/microscopy-atlas.html |title=AAFP Physician's Office Laboratory Microscopy Atlas |author=American Academy of Family Physicians |publisher=American Academy of Family Physicians |edition=4th |year=2013 |pages=125 |isbn=9781940373003}}
Finally, this leads us to the realization that materials, by definition, are inherently linked to the act of intentional human- or automation-driven creation, i.e., manufacturing and construction.
* {{cite book |url=https://books.google.com/books?id=HB2kDwAAQBAJ&printsec=frontcover |title=Accurate Results in the Clinical Laboratory: A Guide to Error Detection and Correction |author=Dasgupta, A.; Sepulveda, J.L. |publisher=Elsevier |edition=2nd |year=2019 |pages=510 |isbn=9780128137772}}
* {{cite book |url=https://www.elsevier.com/books/laboratory-and-diagnostic-testing-in-ambulatory-care/major/978-0-323-53223-5 |title=Laboratory and Diagnostic Testing in Ambulatory Care: A Guide for Health Care Professionals |author=Garrels, Marti; Oatis, Carol S. |publisher=Elsevier Health Sciences |edition=4th |year=2018 |pages=368 |isbn=9780323532235}}
* {{cite book |url=https://evolve.elsevier.com/cs/product/9780323675192 |title=Mosby's Diagnostic and Laboratory Test Reference |author=Pagana, Kathleen Deska; Pagana, Timothy J.; Pagana, Theresa N. |publisher=Elsevier Health Sciences |edition=15th |year=2021 |pages=1104 |isbn=9780323675192}}
* {{cite book |url=https://www.elsevier.com/books/linne-and-ringsruds-clinical-laboratory-science/turgeon/978-0-323-53082-8 |title=Linne & Ringsrud's Clinical Laboratory Science |author=Turgeon, M. |publisher=Elsevier Health Sciences |edition=8th |year=2018 |pages=704 |isbn=9780323549837}}
* {{cite book |url=https://www.wiley.com/en-us/Health+Care+Information+Systems%3A+A+Practical+Approach+for+Health+Care+Management%2C+5th+Edition-p-9781119853879 |title=Health Care Information Systems: A Practical Approach for Health Care Management |author=Wager, K.A.; Lee, F.W.; Glaser, J.P. |publisher=Wiley |year=2021 |pages=416 |isbn=9781119853879}}


'''Industry magazines'''


* {{cite web |url=https://www.labmanager.com/magazine |title=Lab Manager Magazine |publisher= LabX Media Group |date=2022}}
===1.1 Materials testing labs, then and now===
* {{cite web |url=https://www.mlo-online.com/magazine |title=Medical Laboratory Observer Magazine |publisher=Endeavor Business Media, LLC |date=2022}}
* {{cite web |url=https://www.physiciansofficeresource.com/articles/magazine/ |title=Physicians Office Resource Magazine |publisher=Medical Education Resources, LLC |date=2022}}


====1.1.1 Materials testing 2.0====


===6.3 List of CLIA-waived POL instrument and test kit vendors===
*https://onlinelibrary.wiley.com/doi/full/10.1111/str.12434
The following is a list of vendors verified to sell CLIA-waived instruments and/or test kits. Vendors were pulled from the FDA's [https://www.fda.gov/medical-devices/medical-device-databases/clinical-laboratory-improvement-amendments-download-data downloadable CLIA file] from May 2022. The file was sorted to pull out the CLIA-waived devices, and then the vendors were researched to see if they still actively marketed the listed product(s). In some cases, the vendor listed on the FDA file was acquired by another company. If the associated products were still found to be marketed by the acquiring company, that company name was used. CLIA-waived device and test kit types are given as a general guide to what CLIA-waived items the vendor offers.
*https://onlinelibrary.wiley.com/doi/full/10.1111/str.12370


'''Note''': Do not assume that just because a vendor is listed here all of its offerings are CLIA-waived. Some of these vendors may also sell analyzers and tests that are certified moderate or complex. Additionally, this listing does not name the specific CLIA-waived item(s). It is ultimately up to the potential buyer to verify with the vendor that a specific item is CLIA-waived before purchase.


{{Vendors of CLIA-waived items}}
===1.2 Industries, products, and raw materials===




===6.4 List of other diagnostic instrument and test kit vendors===
===1.3 Laboratory roles and activities in the industry===
The following is a list of additional vendors verified to offer CLIA-certified moderate or complex diagnostic instruments and/or test kits.


'''Note''': Most of these vendors sell analyzers and tests that are CLIA-certified moderate or complex. However, is ultimately up to the potential buyer to verify with the vendor an item's CLIA certification status before purchase.
====1.3.1 R&D roles and activities====
{{Vendors of CLIA-certified moderate or complex items}}


====1.3.2 Pre-manufacturing and manufacturing roles and activities====


===6.5 List of distributors===
====1.3.3 Post-production quality control and regulatory roles and activities====
{|
| STYLE="vertical-align:top;"|
{| class="wikitable collapsible sortable" border="1" cellpadding="5" cellspacing="0"
|-
  ! colspan="4"| Distributors of clinical analyzers, point-of-care equipment, and other medical/laboratory supplies and equipment
|-
  ! style="color:brown; background-color:#ffffee;"| Distributor
  ! style="color:brown; background-color:#ffffee;"| Clinical analyzers?
  ! style="color:brown; background-color:#ffffee;"| Point-of-care?
  ! style="color:brown; background-color:#ffffee;"| Medical/laboratory<br />supplies and equipment?
|-
  | style="font-weight: bold; padding-left:10px;"|[https://adelsys.com/ Adelsys, Inc.]
  | style="background-color:white; padding-left:10px;"|Y
  | style="background-color:white; padding-left:10px;"|N
  | style="background-color:white; padding-left:10px;"|Y
|-
  | style="font-weight: bold; padding-left:10px;"|[https://www.akwmedical.com/ AKW Medical, Inc.]
  | style="background-color:white; padding-left:10px;"|N
  | style="background-color:white; padding-left:10px;"|N
  | style="background-color:white; padding-left:10px;"|Y
|-
  | style="font-weight: bold; padding-left:10px;"|[http://www.alaskascientific.com/catalog.html Alaska Scientific, Inc.]
  | style="background-color:white; padding-left:10px;"|Y
  | style="background-color:white; padding-left:10px;"|Y
  | style="background-color:white; padding-left:10px;"|Y
|-
  | style="font-weight: bold; padding-left:10px;"|[https://andwinsci.com/ Andwin Scientific]
  | style="background-color:white; padding-left:10px;"|Y
  | style="background-color:white; padding-left:10px;"|Y
  | style="background-color:white; padding-left:10px;"|Y
|-
  | style="font-weight: bold; padding-left:10px;"|[https://www.atlanticmedicalsolutions.com/ Atlantic Medical Solutions]
  | style="background-color:white; padding-left:10px;"|Y
  | style="background-color:white; padding-left:10px;"|Y
  | style="background-color:white; padding-left:10px;"|Y
|-
  | style="font-weight: bold; padding-left:10px;"|[https://beachmedical.net/products.htm Beach Medical]
  | style="background-color:white; padding-left:10px;"|Y
  | style="background-color:white; padding-left:10px;"|N
  | style="background-color:white; padding-left:10px;"|N
|-
  | style="font-weight: bold; padding-left:10px;"|[https://www.biogx.com/ BioGX, Inc.]
  | style="background-color:white; padding-left:10px;"|N
  | style="background-color:white; padding-left:10px;"|N
  | style="background-color:white; padding-left:10px;"|Y
|-
  | style="font-weight: bold; padding-left:10px;"|[https://www.blockscientific.com/ Block Scientific, Inc.]
  | style="background-color:white; padding-left:10px;"|Y
  | style="background-color:white; padding-left:10px;"|Y
  | style="background-color:white; padding-left:10px;"|Y
|-
  | style="font-weight: bold; padding-left:10px;"|[https://www.cardinalhealth.com/en/product-solutions/medical/laboratory-products.html Cardinal Health, Inc.]
  | style="background-color:white; padding-left:10px;"|Y
  | style="background-color:white; padding-left:10px;"|Y
  | style="background-color:white; padding-left:10px;"|Y
|-
  | style="font-weight: bold; padding-left:10px;"|[https://cenmedonline.com/ Cen-Med Enterprises]
  | style="background-color:white; padding-left:10px;"|N
  | style="background-color:white; padding-left:10px;"|Y
  | style="background-color:white; padding-left:10px;"|Y
|-
  | style="font-weight: bold; padding-left:10px;"|[https://store.clarksonlab.com/ Clarkson Laboratory and Supply, Inc.]
  | style="background-color:white; padding-left:10px;"|Y
  | style="background-color:white; padding-left:10px;"|Y
  | style="background-color:white; padding-left:10px;"|Y
|-
  | style="font-weight: bold; padding-left:10px;"|[https://clearchemdiagnostics.com/products/ ClearChem Diagnostics]
  | style="background-color:white; padding-left:10px;"|Y
  | style="background-color:white; padding-left:10px;"|N
  | style="background-color:white; padding-left:10px;"|Y
|-
  | style="font-weight: bold; padding-left:10px;"|[https://www.coleparmer.com/c/laboratory-equipment Cole-Parmer Instrument Company, LLC]
  | style="background-color:white; padding-left:10px;"|N
  | style="background-color:white; padding-left:10px;"|N
  | style="background-color:white; padding-left:10px;"|Y
|-
  | style="font-weight: bold; padding-left:10px;"|[http://www.custompackinc.com/default.aspx Custom Pack, Inc.]
  | style="background-color:white; padding-left:10px;"|N
  | style="background-color:white; padding-left:10px;"|N
  | style="background-color:white; padding-left:10px;"|Y
|-
  | style="font-weight: bold; padding-left:10px;"|[https://www.daigger.com/ Daigger Scientific, Inc.]
  | style="background-color:white; padding-left:10px;"|N
  | style="background-color:white; padding-left:10px;"|N
  | style="background-color:white; padding-left:10px;"|Y
|-
  | style="font-weight: bold; padding-left:10px;"|[https://www.dremed.com/ DRE Medical, Inc.]
  | style="background-color:white; padding-left:10px;"|N
  | style="background-color:white; padding-left:10px;"|N
  | style="background-color:white; padding-left:10px;"|Y
|-
  | style="font-weight: bold; padding-left:10px;"|[https://hellodynamic.com/collections/lab-supplies-equipment Dynamic Diagnostics, Inc.]
  | style="background-color:white; padding-left:10px;"|N
  | style="background-color:white; padding-left:10px;"|N
  | style="background-color:white; padding-left:10px;"|Y
|-
  | style="font-weight: bold; padding-left:10px;"|[https://www.expotechusa.com/index.asp ExpotechUSA, Inc.]
  | style="background-color:white; padding-left:10px;"|N
  | style="background-color:white; padding-left:10px;"|Y
  | style="background-color:white; padding-left:10px;"|Y
|-
  | style="font-weight: bold; padding-left:10px;"|[https://chem-tran.com/ Federal Industries Corporation]
  | style="background-color:white; padding-left:10px;"|N
  | style="background-color:white; padding-left:10px;"|N
  | style="background-color:white; padding-left:10px;"|Y
|-
  | style="font-weight: bold; padding-left:10px;"|[https://www.fishersci.com/us/en/home.html?storeId=10652 Fisher Healthcare]
  | style="background-color:white; padding-left:10px;"|Y
  | style="background-color:white; padding-left:10px;"|Y
  | style="background-color:white; padding-left:10px;"|Y
|-
  | style="font-weight: bold; padding-left:10px;"|[https://www.foxscientific.com/ Fox Scientific, Inc.]
  | style="background-color:white; padding-left:10px;"|U
  | style="background-color:white; padding-left:10px;"|U
  | style="background-color:white; padding-left:10px;"|Y
|-
  | style="font-weight: bold; padding-left:10px;"|[https://www.foxxlifesciences.com/ Foxx Life Sciences, LLC]
  | style="background-color:white; padding-left:10px;"|N
  | style="background-color:white; padding-left:10px;"|N
  | style="background-color:white; padding-left:10px;"|Y
|-
  | style="font-weight: bold; padding-left:10px;"|[https://geneq.com/ GENEQ, Inc.]
  | style="background-color:white; padding-left:10px;"|N
  | style="background-color:white; padding-left:10px;"|N
  | style="background-color:white; padding-left:10px;"|Y
|-
  | style="font-weight: bold; padding-left:10px;"|[https://www.henryschein.com/us-en/medical/products/lab-supplies/physicians-office-lab.aspx Henry Schein, Inc.]
  | style="background-color:white; padding-left:10px;"|Y
  | style="background-color:white; padding-left:10px;"|Y
  | style="background-color:white; padding-left:10px;"|Y
|-
  | style="font-weight: bold; padding-left:10px;"|[https://htidiagnostics.com/ High Technology, Inc.]
  | style="background-color:white; padding-left:10px;"|Y
  | style="background-color:white; padding-left:10px;"|Y
  | style="background-color:white; padding-left:10px;"|Y
|-
  | style="font-weight: bold; padding-left:10px;"|[https://www.hoskin.ca/catalog/index.php?main_page=index Hoskin Scientific, Ltd.]
  | style="background-color:white; padding-left:10px;"|N
  | style="background-color:white; padding-left:10px;"|N
  | style="background-color:white; padding-left:10px;"|Y
|-
  | style="font-weight: bold; padding-left:10px;"|[https://impactdiagnostic.com/ Impact Diagnostic International]
  | style="background-color:white; padding-left:10px;"|N
  | style="background-color:white; padding-left:10px;"|Y
  | style="background-color:white; padding-left:10px;"|Y
|-
  | style="font-weight: bold; padding-left:10px;"|[https://www.intermedico.com/products Inter Medico]
  | style="background-color:white; padding-left:10px;"|Y
  | style="background-color:white; padding-left:10px;"|N
  | style="background-color:white; padding-left:10px;"|Y
|-
  | style="font-weight: bold; padding-left:10px;"|[https://www.labsupplyspecialists.com/ Lab Supply Specialists]
  | style="background-color:white; padding-left:10px;"|Y
  | style="background-color:white; padding-left:10px;"|Y
  | style="background-color:white; padding-left:10px;"|Y
|-
  | style="font-weight: bold; padding-left:10px;"|[https://www.mccoymedical.com/mccoyhealth/default2.aspx McCoy Health Science Supply]
  | style="background-color:white; padding-left:10px;"|N
  | style="background-color:white; padding-left:10px;"|N
  | style="background-color:white; padding-left:10px;"|Y
|-
  | style="font-weight: bold; padding-left:10px;"|[https://www.mcguffmedical.com/ McGuff Company, Inc.]
  | style="background-color:white; padding-left:10px;"|N
  | style="background-color:white; padding-left:10px;"|Y
  | style="background-color:white; padding-left:10px;"|Y
|-
  | style="font-weight: bold; padding-left:10px;"|[https://mms.mckesson.com/content/customers-we-serve/physician-office-labs/ McKesson Medical-Surgical]
  | style="background-color:white; padding-left:10px;"|Y
  | style="background-color:white; padding-left:10px;"|Y
  | style="background-color:white; padding-left:10px;"|Y
|-
  | style="font-weight: bold; padding-left:10px;"|[https://www.mcmaster.com/laboratory/ McMaster-Carr Supply]
  | style="background-color:white; padding-left:10px;"|N
  | style="background-color:white; padding-left:10px;"|N
  | style="background-color:white; padding-left:10px;"|Y
|-
  | style="font-weight: bold; padding-left:10px;"|[https://www.medical-and-lab-supplies.com/ Med Lab Supply]
  | style="background-color:white; padding-left:10px;"|N
  | style="background-color:white; padding-left:10px;"|Y
  | style="background-color:white; padding-left:10px;"|Y
|-
  | style="font-weight: bold; padding-left:10px;"|[https://medicaldistributiongroup.com/ Medical Distribution Group, Inc.]
  | style="background-color:white; padding-left:10px;"|N
  | style="background-color:white; padding-left:10px;"|N
  | style="background-color:white; padding-left:10px;"|Y
|-
  | style="font-weight: bold; padding-left:10px;"|[https://www.medicus-health.com/laboratory-equipment.html Medicus Health]
  | style="background-color:white; padding-left:10px;"|N
  | style="background-color:white; padding-left:10px;"|N
  | style="background-color:white; padding-left:10px;"|Y
|-
  | style="font-weight: bold; padding-left:10px;"|[https://www.medline.com/category/Exam-and-Diagnostic/cat500085 Medline Industries, Inc.]
  | style="background-color:white; padding-left:10px;"|N
  | style="background-color:white; padding-left:10px;"|Y
  | style="background-color:white; padding-left:10px;"|Y
|-
  | style="font-weight: bold; padding-left:10px;"|[https://www.mercedesscientific.com/ Mercedes Scientific, Inc.]
  | style="background-color:white; padding-left:10px;"|Y
  | style="background-color:white; padding-left:10px;"|Y
  | style="background-color:white; padding-left:10px;"|Y
|-
  | style="font-weight: bold; padding-left:10px;"|[https://www.omnilab.de/ OMNILAB-LABORZENTRUM GmbH & Co. KG]
  | style="background-color:white; padding-left:10px;"|Y
  | style="background-color:white; padding-left:10px;"|N
  | style="background-color:white; padding-left:10px;"|Y
|-
  | style="font-weight: bold; padding-left:10px;"|[https://preiser.com/ Preiser Scientific]
  | style="background-color:white; padding-left:10px;"|N
  | style="background-color:white; padding-left:10px;"|N
  | style="background-color:white; padding-left:10px;"|Y
|-
  | style="font-weight: bold; padding-left:10px;"|[https://www.rweinstein.com/ R. Weinstein Pharmaceuticals & Medical Products]
  | style="background-color:white; padding-left:10px;"|Y
  | style="background-color:white; padding-left:10px;"|Y
  | style="background-color:white; padding-left:10px;"|Y
|-
  | style="font-weight: bold; padding-left:10px;"|[https://www.siemens-healthineers.com/ Siemens Healthcare GmbH]
  | style="background-color:white; padding-left:10px;"|Y
  | style="background-color:white; padding-left:10px;"|Y
  | style="background-color:white; padding-left:10px;"|N
|-
  | style="font-weight: bold; padding-left:10px;"|[https://stat-technologies.com/store/ Stat Technologies]
  | style="background-color:white; padding-left:10px;"|Y
  | style="background-color:white; padding-left:10px;"|Y
  | style="background-color:white; padding-left:10px;"|Y
|-
  | style="font-weight: bold; padding-left:10px;"|[https://www.techneal.com/products TechNeal, Inc.]
  | style="background-color:white; padding-left:10px;"|Y
  | style="background-color:white; padding-left:10px;"|Y
  | style="background-color:white; padding-left:10px;"|Y
|-
  | style="font-weight: bold; padding-left:10px;"|[https://www.thomassci.com/ Thomas Scientific]
  | style="background-color:white; padding-left:10px;"|N
  | style="background-color:white; padding-left:10px;"|N
  | style="background-color:white; padding-left:10px;"|Y
|-
  | style="font-weight: bold; padding-left:10px;"|[https://troybio.com/ Troy Biologicals, Inc.]
  | style="background-color:white; padding-left:10px;"|N
  | style="background-color:white; padding-left:10px;"|Y
  | style="background-color:white; padding-left:10px;"|Y
|-
  | style="font-weight: bold; padding-left:10px;"|[https://www.universalmedicalinc.com/all-products/laboratory.html Universal Medical]
  | style="background-color:white; padding-left:10px;"|N
  | style="background-color:white; padding-left:10px;"|N
  | style="background-color:white; padding-left:10px;"|Y
|-
  | style="font-weight: bold; padding-left:10px;"|[https://www.usspecialtylabs.com/ US Specialty Labs]
  | style="background-color:white; padding-left:10px;"|Y
  | style="background-color:white; padding-left:10px;"|N
  | style="background-color:white; padding-left:10px;"|N
|-
  | style="font-weight: bold; padding-left:10px;"|[https://www.usabluebook.com/c-1509-lab-instruments-equipment-amp-supplies.aspx?CategoryID=1509 USABluebook]
  | style="background-color:white; padding-left:10px;"|N
  | style="background-color:white; padding-left:10px;"|N
  | style="background-color:white; padding-left:10px;"|Y
|-
  | style="font-weight: bold; padding-left:10px;"|[https://vesselmedical.com/equipment/ Vessel Medical]
  | style="background-color:white; padding-left:10px;"|Y
  | style="background-color:white; padding-left:10px;"|Y
  | style="background-color:white; padding-left:10px;"|N
|-
  | style="font-weight: bold; padding-left:10px;"|[https://us.vwr.com/store/ VWR International]
  | style="background-color:white; padding-left:10px;"|Y
  | style="background-color:white; padding-left:10px;"|Y
  | style="background-color:white; padding-left:10px;"|Y
|-
  | style="font-weight: bold; padding-left:10px;"|[https://www.grainger.com/ W.W. Grainger, Inc.]
  | style="background-color:white; padding-left:10px;"|N
  | style="background-color:white; padding-left:10px;"|N
  | style="background-color:white; padding-left:10px;"|Y
|-
|}
|}


===6.6 List of consultants in the POL market===
==References==
The following consultancies state they assist the POL market on their website:
{{Reflist|colwidth=30em}}
 
<div style="text-align: left;">
{| id="LIMSvendor" border="1" cellpadding="5" cellspacing="0" align="center"
! Vendor
! Headquarters
! Key services
! Services page
|-
  | [http://ams-labs.com/ AMS Medical Laboratories]
  | St. Louis, MO, U.S.
  | Laboratory start-up, pre-inspection evaluation, post-inspection correction, workflow improvement,<br />profitability analysis, procedure development, etc.
  | [http://ams-labs.com/consulting-services/ Services page]
|-
|-
  | [https://www.ancillarymedsolutions.com/ Ancillary Medical Solutions]
  | San Diego, CA, U.S.
  | Laboratory start-up, pre-inspection evaluation, post-inspection correction, workflow improvement,<br />staffing, procedure development, etc.
  | [https://www.ancillarymedsolutions.com/in-house-lab.php Services page]
|-
|-
  | [http://bplaboratoryconsulting.com/ BP Laboratory Consulting, LLC]
  | Arvada, CO, U.S.
  | Laboratory start-up, workflow improvement, procedure development, training, regulatory compliance, etc.
  | [http://bplaboratoryconsulting.com/services Services page]
|-
|-
  | [http://www.clinicallaboratoryconsulting.com/ C&C Clinical Laboratory Consulting, LLC]
  | Dallas, TX, U.S.
  | Laboratory start-up, pre-inspection evaluation, post-inspection correction, workflow improvement,<br />quality management, procedure development, etc.
  | [http://www.clinicallaboratoryconsulting.com/services.html Services page]
|-
|-
  | [http://www.cmmlabconsulting.com/ Carlos M. Madan & Associates]
  | Dallas, TX, U.S.
  | Laboratory start-up, workflow improvement, quality management, procedure development, training,<br />profitability analysis, etc.
  | [http://www.cmmlabconsulting.com/page1/services.html Services page]
|-
 
|-
  | [http://www.catalyst-consultants.com/ Catalyst Consulting]
  | Austin, TX, U.S.
  | Laboratory start-up, regulatory compliance, workflow improvement, profitability analysis
  | [http://www.catalyst-consultants.com/#!services/ca4p Services page]
|-
|-
  | [http://www.clinicallabconsulting.com/ Clinical Lab Consulting, LLC]
  | Carmel, IN, U.S.
  | Provides a wide range of services "to all types of clinical laboratories including governmental, academia,<br />hospital, reference and physician office laboratories."
  | [http://www.clinicallabconsulting.com/general-consulting/ Services page]
|-
|-
  | [http://www.consultants-lab.com/ Clinical Laboratory Consultants dba Medical Source]
  | Marietta, GA, U.S.
  | "Medical Source offers experience, guidance, and unmatched expertise in the physician office and<br />independent reference laboratory."
  | [http://consultants-lab.com/lab-consulting Services page]
|-
 
|-
  | [http://ctpolconsultants.com/ CT POL Consultants]
  | South Windsor, CT, U.S.
  | Laboratory start-up, pre-inspection evaluation, post-inspection correction, workflow improvement,<br />LIS, EHR, lab billing, procedure development, etc.
  | [http://ctpolconsultants.com/services/ Services page]
|-
|-
  | [http://www.doctors-management.com/ DoctorsManagement]
  | Knoxville, TN, U.S.
  | Laboratory and physician practice accounting, compliance, development, and operation improvement
  | [http://www.doctors-management.com/ Services page]
|-
|-
  | [http://www.elitechgroup.com/ ELITech Group SAS]
  | Puteaux, France
  | Laboratory operations, billing and reimbursement, regulatory assistance, profitability analysis
  | [http://www.elitechgroup.com/north-america/products/market-segment/total-lab-care Services page]
|-
|-
  | [http://gnosisint.com/ Gnosis International, LLC]
  | Garden Grove, CA, U.S.
  | Laboratory start-up, laboratory operations, regulatory assistance
  | [http://gnosisint.com/service/ Services page]
|-
|-
  | [http://www.harrisonconsultant.com/ Harrison Consultant]
  | Cleveland, TX, U.S.
  | Pre-inspection evaluation, quality management, regulatory compliance,<br />procedure development, technical writing, etc.
  | [http://www.harrisonconsultant.com/laboratory_consulting Services page]
|-
|-
  | [http://www.knkconsult.com/ K&K Consultant Group, Inc.]
  | Torrence, CA, U.S.
  | Laboratory start-up, pre-inspection evaluation, post-inspection correction, workflow improvement,<br />training, procedure development, etc.
  | [http://www.knkconsult.com/services Services page]
|-
|-
  | [http://labadvisory.com/ Lab Advisory Bureau]
  | Abilene, TX, U.S.
  | Data management, quality managementm, regulatory guidance, training, accreditation prep
  | [http://labadvisory.com/Our-Services Services page]
|-
|-
  | [http://www.labiqllc.com/ Lab IQ, LLC]
  | Calabasas, CA, U.S.
  | Compliance management, workflow improvement, training, procedure development, feasibility studies, etc.
  | [http://www.labiqllc.com/ Services page]
|-
|-
  | [http://www.labiqllc.com/ LabMetrics, LLC]
  | Ishpeming, MI, U.S.
  | Laboratory start-up, compliance management, workflow improvement, procedure development, revenue management, etc.
  | [http://www.labiqllc.com/ Services page]
|-
 
|-
  | [http://www.liswalter.com/ LisWalter Consulting]
  | New York, NY, U.S.
  | Laboratory informatics, compliance management, quality management, procedure development, training, etc.
  | [http://www.liswalter.com/services.html Services page]
|-
|-
  | [http://www.medicallab.consulting/ Medical Lab Consulting]
  | Oklahoma City, OK, U.S.
  | Application processing, staffing, training, workflow management, inspection preparation
  | [http://www.medicallab.consulting/pricing/ Services page]
|-
|-
  | [http://www.narayanconsultinginc.com/ Narayan Laboratory Consulting Services, Inc.]
  | Philadelphia, PA, U.S.
  | Laboratory start-up, regulatory requirements, training, process development, pre- and post-inspection<br />guidance, quality management, inspection readiness
  | [http://www.narayanconsultinginc.com/#!services/c1pna Services page]
|-
|-
  | [https://www.nicholsmanagementgroup.com/ Nichols Management Group Ltd.]
  | York Harbor, ME, U.S.
  | "NMG is the laboratory business! We provide advisory, financial, operational and technical assistance to the<br />full spectrum of the healthcare industry."
  | [http://nuemedical.com/laboratory-services/ Services page]
|-
 
|-
  | [http://nuemedical.com/ NueMedical Consulting]
  | Lawrenceville, GA, U.S.
  | Moderate to complex toxicology laboratory setup and organization
  | [http://nuemedical.com/laboratory-services/ Services page]
|-
 
|-
  | [http://www.ontargetconsulting.biz/ OnTarget Consulting Services, LLC]
  | Atlanta, GA, U.S.
  | Accreditation prep, operational and risk assessment, training, process management
  | [http://www.ontargetconsulting.biz/laboratory-consulting Services page]
|-
|-
  | [http://polconsultant.com/ Physicians Office Consulting, LLC]
  | Jackson, TN, U.S.
  | Laboratory CLIA compliance, regulatory review, and inspection services; laboratory start-up and development
  | [http://polconsultant.com/labservices.htm Services page]
|-
|-
  | [http://polspecialists.com/ Physicians Office Laboratory Specialists, Inc.]
  | Puyallup, WA, U.S.
  | Urine drug testing, opioid addiction treatment
  | [http://polspecialists.com/index.php/pols/services Services page]
|-
|-
  | [http://www.pocconsults.com/ POC Consultants, LLC ]
  | FL and NJ, U.S.
  | Regulatory compliance, review, and inspection services; training
  | [http://www.pocconsults.com/services.aspx Services page]
|-
|}
</div>
 
==6.7 List of consumables and supplies used in POL===
====6.7.1 Diagnostic analyzers and devices (CLIA-waived)====
* blood analyzers
* blood glucose monitors
* chemistry analyzers
* digital immunoassay analyzer
* fertility monitor
* hematology devices
* molecular immunoassay analyzer
* urine analyzers
 
====6.7.2 Diagnostic test kits and supplies (CLIA-waived)====
* blood glucose test strips
* adenoviral conjunctivitis
* bladder tumor associated antigen (BTA)
* drug screen
* fecal occult blood
* follicle-stimulating hormone (FSH)
* gastrick pH
* gastric occult blood
* hCG pregnancy test
* Hepatitis C virus antibody (HCV)
* HDL cholestrol
* HIV-1 and/or HIV-2
* H. pylori
* influenza A and/or B
* MMP-9 protein (for dry eye disease)
* mononucleosis
* ovulation test
* respiratory syncytial virus (RSV)
* semen (fertility)
* Strep A
* syphilis
* trichomonas
* thyroid-stimulating hormone (TSH)
* urine reagent strips
* vaginal pH
 
====6.7.3 Laboratory furniture and equipment====
* balances
* blood pressure meters
* cabinets and stands
* carts
* centrifuges
* chairs: doctor and patient
* EKG machines
* eyewash stations
* fume hoods
* glove boxes
* hot plates
* incubators
* lighting
* mats and trays
* microscopes and accessories
* mills
* mixers
* otoscopes
* refrigerators and freezers
* scales
* sharps containers
* stethoscopes
* sterilization equipment
* tables
* thermometers
* tube rockers
* waste containers
 
====6.7.4 Medical supplies====
* bandages and dressings
* buffers, reagents, and solvents
* catheters
* cleaning supplies
* eyeware and safety goggles
* face and splash shields
* gloves: chloroprene, latex, synthetic, vinyl
* gowns
* labels and tapes
* masks
* needles, lancets, and other sharps
* ointments
* pipettes
* swabs and applicators
* surgical instruments
* table paper
* timers
* tourniquets
* tube racks
* urine and stool containers
* vacutainer tubes
* wipes
* wound cleaners
 
===6.8 Laboratory billing and revenue enhancement===
These businesses are known to provide revenue management and improvement services to laboratories. Additionally, a handful of these businesses may also offer their own laboratory billing software solutions in addition providing billing services.
 
* [https://www.adsc.com/laboratory-billing-services Advanced Data Systems Corporation]
* [https://www.affinitybilling.com/ Affinity Billing, Inc.]
* [https://amcbillingservices.com/ AMC Billing Services, LLC]
* [https://apsmedbill.com/ APS Medical Billing, Inc.]
* [https://www.bikham.com/medical-laboratory-billing-services Bikham Information Technology Corporation]
* [https://www.changehealthcare.com/solutions/clinical-labs Change Healthcare, Inc.]
* [https://claimcare.com/ ClaimCare, Inc.]
* [https://www.collaboratemd.com/medical-billing-service-pricing CollaborateMD, Inc.]
* [https://healthteqservices.com/ Healthteq Services, LLC]
* [http://infallibill.com/lab-billing/ Infallibill Corp.]
* [https://kellison.com/billing-services/ Kellison & Co.]
* [https://www.laboratorybilling.com/ Laboratory Billing Solutions, Inc.]
* [https://www.laboratoryexperts.com/ Laboratory Experts, LLC]
* [https://medcaremso.com/ Medcare MSO, LLC]
* [https://www.medconverge.com/ MedConverge, LLC]
* [https://metropm.com/ MPM, Inc.]
* [http://www.sunshinebilling.com/ The Negotiators, LLC]
* [https://phoenixhcs.com/laboratories/ Phoenix Healthcare Services, Inc.]
* [https://www.pgmbilling.com/ Physicians Group Management, LLC]
* [https://ahsrcm.com/solutions/billing/ Physicians' Service Center, Inc.]
* [http://www.practisource.com/medical-and-lab-billing/ PractiSource, LLC]
* [https://www.quadax.com/solutions/laboratories/ Quadax, Inc.]
* [https://questns.com/ Quest National Services, LLC]
* [http://rpmbilling.com/ RPM Billing, LLC]
* [http://www.softactics.com/services/medical-billing-software.html Softactics, Inc.]
* [https://telcor.com/trcs-billing-service/ TELCOR, Inc.]
 
==Citation information for this chapter==
'''Chapter''': 6. Additional resources
 
'''Title''': ''The Comprehensive Guide to Physician Office Laboratory Setup and Operation''
 
'''Author for citation''': Shawn E. Douglas
 
'''License for content''': [https://creativecommons.org/licenses/by-sa/4.0/ Creative Commons Attribution-ShareAlike 4.0 International]
 
'''Publication date''': May 2022
 
<!--Place all category tags here-->

Latest revision as of 23:51, 20 September 2023

Sandbox begins below

1. Introduction to materials and materials testing laboratories

What is a material? This question is surprisingly more complex for the layperson than may be expected. The definition of "material" has varied significantly over the years, dependent on the course of study, laboratory, author, etc. A 1974 definition by Richardson and Peterson that has seen some use in academic study defines a material as "any nonliving matter of academic, engineering, or commercial importance."[1] But recently biomaterials like biopolymers (as replacements for plastics)[2] and even natural[3] and engineered biological tissues[4] may be referenced as "materials." (And to Richardson and Peterson's credit, they do add in the preface of their 1974 work that "[a]lthough the volumes are directed toward the physical sciences, they can also be of value for the biological scientist with materials problems."[5] A modern example would be biodegradable materials research for tissue and medical implant engineering.[6]) Yet today more questions arise. what of matter that doesn't have "academic, engineering, or commercial importance"; can it now be called a "material" in 2023? What if a particular matter exists today but hasn't been thoroughly studied to determine its value to researchers and industrialists? Indeed, the definition of "material" today is no easy task. This isn't made easier when even modern textbooks introduce the topic of materials science without aptly defining what a material actually is[7], let alone what materials science is.[8] Perhaps the writers of said textbooks assume that the definitions of "material" and "materials science" have a "well duh" response.

To complicate things further, a material can be defined based upon the context of use. Take for example the ISO 10303-45 standard by the International Organization for Standardization (ISO), which addresses the representation and exchange of material and product manufacturing information in a standardized way, specifically describing how material and other engineering properties can be described in the model/framework.[9][10] The context here is "standardized data transfer of material- and product-related data," which in turn involves ontologies that limit the complexity of materials science discourse and help better organize materials and product data into information and knowledge. As such, the ISO 10303 set of standards must define "material," and 10303-45 complicates matters further in this regard (though it will be helpful for this guide in the end).

In reviewing ISO 10303-45 in 2009, Swindells notes the following about the standard[10]:

The first edition of ISO 10303-45 was derived from experience of the testing of, so-called, "materials" properties, and the terminology used in the standard reflects this experience. However, the information modelling of an engineering material, such as alloyed steel or high density polyethylene, is no different from the information modelling of a "product." The "material" properties are therefore one of the characteristics of a product, just as its shape and other characteristics are. Therefore all "materials" are products, and the information model in ISO 10303-45 can be used for any property of any product.

Put in other words, for the purposes of defining "material" for a broader, more standardized ontology, materials and products can be viewed as interchangeable. Mies puts this another way, stating that based on ISO 10303-45, a material can be defined as "a manufactured object with associated properties in the context of its use environment."[11] But this representation only causes more confusion as we ask "does a material have to be manufactured?" After all, we have the term "raw material," which the Oxford English Dictionary defines as "the basic material from which a product is manufactured or made; unprocessed material."[12] Additionally, chemical elements are defined as "the fundamental materials of which all matter is composed."[13] Taking into account the works of Richardson and Peterson, Mies, and Swindells, as well as ISO 10303-45, the concepts of "raw materials" and "chemical elements," and modern trends towards the inclusion of biomaterials (though discussion of biomaterials will be limited here) in materials science, we can land on the following definition for the purposes of this guide:

A material is discrete matter that is elementally raw (e.g., native metallic and non-metallic elements), fundamentally processed (e.g., calcium oxide), or fully manufactured (by human, automation, or both; e.g., a fastener) that has an inherent set of properties that a human or automation-driven solution (e.g., an artificial intelligence [AI] algorithm) has identified for a potential or realized use environment.

First, this definition more clearly defines the types of matter that can be included, recognizing that manufactured products may still be considered materials. Initially this may seem troublesome, however, in the scope of complex manufactured products such as automobiles and satellites; is anyone really referring to those types of products as "materials"? As such, the word "discrete" is included, which in manufacturing parlance refers to distinct components such as brackets and microchips that can be assembled into a greater, more complex finished product. This means that while both a bolt and an automobile are manufactured "products," the bolt, as a discrete type of matter, can be justified as a material, whereas the automobile can't. Second—answering the question of "what if a particular matter exists today but hasn't been thoroughly studied to determine its value to researchers and industrialists?"—the definition recognizes that the material needs at a minimum recognition of a potential use case. This turns out to be OK, because if no use case has been identified, the matter still can be classified as an element, compound, or substance. It also insinuates that that element, compound, or substance with no use case isn't going to be used in the manufacturing of any material or product. Third, the definition also recognizes the recent phenomena of autonomous systems discovering new materials and whether or not those autonomous systems should be credited with inventorship.[14] The question of inventorship is certainly worth discussion, though it is beyond the scope of this guide. Regardless, the use of automated systems to match a set of properties of a particular matter to a real-world use case isn't likely to go away, and this definition accepts that likelihood.

Finally, this leads us to the realization that materials, by definition, are inherently linked to the act of intentional human- or automation-driven creation, i.e., manufacturing and construction.


1.1 Materials testing labs, then and now

1.1.1 Materials testing 2.0


1.2 Industries, products, and raw materials

1.3 Laboratory roles and activities in the industry

1.3.1 R&D roles and activities

1.3.2 Pre-manufacturing and manufacturing roles and activities

1.3.3 Post-production quality control and regulatory roles and activities

References

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