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| type      = notice
| type      = notice
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| 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===
The [[physician office laboratory]] (POL) has come a long way since its humble origins in the 1800s, using urinalysis to diagnose patient afflictions. The modern POL has a wider range of testing options thanks to evolutions in technologies such as [[molecular diagnostics]]. Yet they are also more regulated today (at least in the U.S.) than their ancestors, with the likes of the [[Clinical Laboratory Improvement Amendments]] (CLIA) framing test complexity and the requirements that come with each level of complexity. Laboratory testing is not all that is regulated either, with the [[Health Insurance Portability and Accountability Act]] of 1996 (HIPAA) dictating how data and other information generated from testing must be protected. Add to that concerns about ensuring financial reimbursement for testing, maintaining competent staff, implementing and reviewing standardized procedures, tracking specimens, and reporting results in a timely and accurate fashion; this can leave the enterprising physician office doubting whether a POL is worth the effort.


However, the promise of caring for a patient's needs at or near the point of care—and the benefits that come with that—remains strong. Yes, pharmacy laboratories have increasingly sprung up in the last 10 years, taking away some of the momentum of the POL, but the physician isn't found at the pharmacy. Patients will continue to visit their physician, and many will continue to get value from having some level of laboratory testing at the physician office. This is usually represented by a set of specific tests that lend themselves well to being conducted relatively easily and interpreted rapidly. Types of urinalysis, blood analysis, clinical chemistry, and immunological analysis—particularly those that are CLIA-waived—are most likely to be employed in the POL for a number of conditions, diseases, or analytes, including pregnancy, cholesterol, thyroid-stimulating hormone, and mononucleosis.
In reviewing ISO 10303-45 in 2009, Swindells notes the following about the standard<ref name=":0" />:


This testing requires thoughtful [[workflow]] preparation and management that takes into account not only the order of operations but also the flow of information. Data and information management practices are important to the POL, and if their workload justifies it, the POL may require software solutions like [[laboratory information system]]s (LIS) and [[electronic health record]]s (EHRs). However, implementing such systems isn't necessarily straightforward, requiring additional considerations about budget and usefulness. Decisions on such software implementations, as well as the testing the lab conducts and how it's conducted, requires knowledgeable personnel who have been trained in information systems and testing protocols. How the laboratory is classified with CLIA will determine whether or not a laboratory manager is a hard requirement; however, in all cases someone should be taking the lead on POL operations. Are processes and procedures properly documented? Is there a quality management process in the POL? Does the lab participate in proficiency testing? These and other aspects of the POL must be addressed, regardless of the POL's CLIA classification.
<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>


In the end, a POL still serves an important role within the sphere of clinical laboratory testing. As molecular testing options continue to expand to the point of care, the POL will likely see additional opportunities to expand its test menu. This was seen with the emergence of the [[COVID-19]] pandemic and the demand for rapid molecular testing that came with it, which made clear that a quick diagnosis at the physician's office, among other locations, is valuable to patient management and treatment. But the POL's continued utility and success will largely hinge upon effective setup and management, which in turn requires knowledgeable and motivated people to ensure the POL's long-term success.
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.elitechgroup.com/ ELITech Group]
  | 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.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
 
|-
  | [https://thelaboratoryconsultants.com/ A&J Laboratory Consultants]
  | Dallas, TX, U.S.
  | Laboratory start-up, pre-inspection evaluation, post-inspection correction, workflow improvement, quality management, procedure development, etc.
  | [https://thelaboratoryconsultants.com/consulting/ Services page]
|-
|-
  | [https://ameds.every-ancillary.com/ Ancillary Medical Solutions]
  | Beachwood, OH, U.S.
  | "Our comprehensive portfolio of medical ancillary programs are designed to help medical clinics improve practice efficiency, increase revenue, and deliver the highest level of care to patients."
  | [https://ameds.every-ancillary.com/solution/ Services page]
|-
|-
  | [http://beyondlabconsulting.com/ Beyond Lab Consulting]
  | New York, NY, U.S.
  | "Our scope ranges from small physician office labs (POL) to large reference laboratories. BLC consultants are well versed in CLIA regulations, hiring and training of clinical staff, maximizing income while keeping laboratory costs down."
  | [http://beyondlabconsulting.com/services/ Services page]
|-
|-
  | [https://brucepolconsulting.com/ Bruce North Country Consulting Services, LLC]
  | Daytona Beach, FL, U.S.
  | "BNCCS is an experienced provider for physician office laboratories and small to moderate size hospital laboratories ... BNCCS provides expertise in designing, planning, implementing, seeking accreditation, and providing short and long term management."
  | [https://thelaboratoryconsultants.com/consulting/ Services page]
|-
|-
  | [https://cclabconsult.com/ C&C Clinical Laboratory Consulting, LLC]
  | Dallas, TX, U.S.
  | Laboratory start-up, pre-inspection evaluation, post-inspection correction, workflow improvement, quality management, procedure development, etc.
  | [https://cclabconsult.com/services/ Services page]
|-
 
|-
  | [https://www.catalyst-consultants.com/ Catalyst Consulting]
  | Austin, TX, U.S.
  | Laboratory start-up, regulatory compliance, workflow improvement, profitability analysis
  | [https://www.catalyst-consultants.com/services Services page]
|-
|-
  | [http://clinicallabconsultants.com/ Clinical Lab Consultants, LLC]
  | Sanford, FL, U.S.
  | Laboratory start-up, regulatory compliance, plans of correction
  | [http://clinicallabconsultants.com/what-we-do/ Services page]
|-
|-
  | [https://clinicallabconsulting.com/ Clinical Lab Consulting, LLC]
  | Dublin, OH, U.S.
  | Provides a wide range of services "to all types of clinical laboratories including governmental, academia, hospital, reference and physician office laboratories."
  | [https://clinicallabconsulting.com/general-consulting/ Services page]
|-
|-
  | [https://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 independent reference laboratory."
  | [https://consultants-lab.com/laboratory-startup-consultants-clinical-laboratory-consultants/ Services page]
|-
 
|-
  | [https://www.colaborate.com/ Colaborate]
  | Tampa, FL, U.S.
  | "We provide a full range of financial, technical and advisory consultation to fulfill the needs of pathology laboratories, medical laboratories, and clinical laboratories."
  | [https://www.colaborate.com/services Services page]
|-
|-
  | [https://www.ctpolconsultants.com/ CT POL Consultants]
  | South Windsor, CT, U.S.
  | Laboratory start-up, pre-inspection evaluation, post-inspection correction, workflow improvement, LIS, EHR, lab billing, procedure development, etc.
  | [https://www.ctpolconsultants.com/services/ Services page]
|-
|-
  | [https://www.doctorsmanagement.com/ DoctorsManagement]
  | Knoxville, TN, U.S.
  | Laboratory and physician practice accounting, compliance, development, and operation improvement
  | [https://www.doctorsmanagement.com/ Services page]
|-
|-
  | [https://www.ecpclab.com/ Eastern Connecticut Pathology Consultants]
  | Manchester, CT, U.S.
  | Physician office laboratory management
  | [https://www.ecpclab.com/physician-office-lab-management 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, 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]
|-
|-
  | [https://labmetrics.com/ LabMetrics, LLC]
  | Ishpeming, MI, U.S.
  | Laboratory start-up, compliance management, workflow improvement, procedure development, revenue management, etc.
  | [https://labmetrics.com/services/ Services page]
|-
|-
  | [https://www.lighthouselabservices.com/ Lighthouse Lab Services]
  | Charlotte, NC, U.S.
  | Laboratory start-up, compliance management, workflow improvement, procedure development, revenue management, growth strategy, etc.
  | [https://www.lighthouselabservices.com/consulting/ Services page]
|-
|-
  | [https://www.nicholsmanagementgroup.com/ Nichols Management Group Ltd.]
  | York Harbor, ME, U.S.
  | "The Nichols Management Group, LTD., (NMG) provides laboratory consulting services for healthcare organizations. NMG specializes in operations optimization, strategic planning, mergers and acquisitions (M&A), sales and marketing development and go-to-market strategies."
  | [https://www.nicholsmanagementgroup.com/ Services page]
|-
 
|-
  | [https://www.ontargetconsulting.biz/ OnTarget Consulting Services, LLC]
  | Atlanta, GA, U.S.
  | Accreditation prep, operational and risk assessment, training, process management
  | [https://www.ontargetconsulting.biz/laboratory-consulting Services page]
|-
|-
  | [https://poclabtech.com/ Physicians Office Consulting, LLC]
  | Jackson, TN, U.S.
  | Laboratory CLIA compliance, regulatory review, and inspection services; laboratory start-up and development
  | [https://poclabtech.com/services/ 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/ Point of Care Consults]
  | FL and NJ, U.S.
  | Regulatory compliance, review, and inspection services; training
  | [http://pocconsults.com/ Services page]
|-
 
|-
  | [https://www.prosourcelabconsulting.com/ ProSource Lab Consulting, LLC]
  | Jersey City, NJ, U.S.
  | Laboratory start-up, procedure development, regulatory compliance, revenue management, etc.
  | [https://www.prosourcelabconsulting.com/consulting-services Services page]
|-
|-
  | [https://soundlabconsult.com/ Sound Lab Consultants]
  | Phoenix, AZ, U.S.
  | Laboratory feasibility, laboratory start-up, procedure development, revenue management, technical consultation, etc.
  | [https://soundlabconsult.com/services Services page]
|-
|-
  | [https://www.sslabconsultants.com/ South Shore Laboratory Consultants, Inc.]
  | Braintree, MA, U.S.
  | "We have the expertise to facilitate all needs, from initial laboratory start-up through complete licensure, while ensuring continuous maintenance of your regulatory and quality systems."
  | [http://pocconsults.com/ 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
* blood ketone monitors
* blood lead analyzers
* 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
* B-type natriuretic peptide (BNP)
* 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/revenue-cycle-management/reimbursement-management/physician-revenue-cycle-services/clinical-labs Change Healthcare, Inc.]
* [https://claimcare.com/ ClaimCare, Inc.]
* [https://www.collaboratemd.com/pricing/medical-billing-and-labs/ CollaborateMD, Inc.]
* [https://www.coronishealth.com/laboratory-and-pathology/ Coronis Health]
* [https://healthteqservices.com/ Healthteq Services, LLC]
* [https://laboratorybillings.com/ Laboratory Billings]
* [https://www.laboratoryexperts.com/ Laboratory Experts, LLC]
* [https://medcaremso.com/ Medcare MSO, LLC]
* [https://www.medconverge.com/ MedConverge, LLC]
* [https://www.medsphere.com/who-we-serve/labs/ Medsphere Systems Corporation]
* [https://metropm.com/ MPM, Inc.]
* [https://www.sunshinebilling.com/ The Negotiators, LLC]
* [https://phoenixhcs.com/claim-management/ Phoenix Healthcare Services, Inc.]
* [https://www.pgmbilling.com/ Physicians Group Management, LLC]
* [https://ahsrcm.com/solutions/billing/ Physicians' Service Center, Inc.]
* [https://www.quadax.com/laboratory-revenue-cycle-management-software-solutions-billing-services/ Quadax, Inc.]
* [https://questns.com/ Quest National Services, LLC]
* [https://rpmbilling.com/ RPM Billing, LLC]
 
 
==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

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 my discussion page instead.

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

  1. ↑ Richardson, James H.; Peterson, Ronald V. (1974). "Chapter 1: Introduction to Analytical Methods". Systematic Materials Analysis, Part 1. Materials science series. New York: Academic Press. p. 2. doi:10.1016/B978-0-12-587801-2.X5001-0. ISBN 978-0-12-587801-2. 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. 
  2. ↑ Das, Abinash; Ringu, Togam; Ghosh, Sampad; Pramanik, Nabakumar (1 July 2023). "A comprehensive review on recent advances in preparation, physicochemical characterization, and bioengineering applications of biopolymers" (in en). Polymer Bulletin 80 (7): 7247–7312. doi:10.1007/s00289-022-04443-4. ISSN 0170-0839. PMC PMC9409625. PMID 36043186. https://link.springer.com/10.1007/s00289-022-04443-4. 
  3. ↑ Kurniawan, Nicholas A.; Bouten, Carlijn V.C. (1 April 2018). "Mechanobiology of the cell–matrix interplay: Catching a glimpse of complexity via minimalistic models" (in en). Extreme Mechanics Letters 20: 59–64. doi:10.1016/j.eml.2018.01.004. https://linkinghub.elsevier.com/retrieve/pii/S2352431617301864. 
  4. ↑ Kim, Hyun S.; Kumbar, Sangamesh G.; Nukavarapu, Syam P. (1 March 2021). "Biomaterial-directed cell behavior for tissue engineering" (in en). Current Opinion in Biomedical Engineering 17: 100260. doi:10.1016/j.cobme.2020.100260. PMC PMC7839921. PMID 33521410. https://linkinghub.elsevier.com/retrieve/pii/S246845112030057X. 
  5. ↑ Richardson, James H.; Peterson, Ronald V. (1974). "Preface". Systematic Materials Analysis, Part 1. Materials science series. New York: Academic Press. p. xiii. doi:10.1016/B978-0-12-587801-2.X5001-0. ISBN 978-0-12-587801-2. 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. 
  6. ↑ Modrák, Marcel; Trebuňová, Marianna; Balogová, Alena Findrik; Hudák, Radovan; Živčák, Jozef (16 March 2023). "Biodegradable Materials for Tissue Engineering: Development, Classification and Current Applications" (in en). Journal of Functional Biomaterials 14 (3): 159. doi:10.3390/jfb14030159. ISSN 2079-4983. PMC PMC10051288. PMID 36976083. https://www.mdpi.com/2079-4983/14/3/159. 
  7. ↑ Callister, William D.; Rethwisch, David G. (2021). "Chapter 1. Introduction". Fundamentals of materials science and engineering: An integrated approach. Hoboken: Wiley. pp. 2–18. ISBN 978-1-119-74773-4. https://books.google.com/books?id=NC09EAAAQBAJ&newbks=1&newbks_redir=0&printsec=frontcover. 
  8. ↑ Sutton, Adrian P. (2021). Concepts of materials science (First edition ed.). Oxford [England] ; New York, NY: Oxford University Oress. ISBN 978-0-19-284683-9. 
  9. ↑ "ISO 10303-45:2019 Industrial automation systems and integration — Product data representation and exchange — Part 45: Integrated generic resource: Material and other engineering properties". International Organization for Standardization. November 2019. https://www.iso.org/standard/78581.html. Retrieved 20 September 2023. 
  10. ↑ 10.0 10.1 Swindells, Norman (2009). "The Representation and Exchange of Material and Other Engineering Properties" (in en). Data Science Journal 8: 190–200. doi:10.2481/dsj.008-007. ISSN 1683-1470. http://datascience.codata.org/articles/abstract/10.2481/dsj.008-007/. 
  11. ↑ Mies, D. (2002). "Chapter 17. Managing Materials Data". In Kutz, Myer. Handbook of materials selection. New York: J. Wiley. p. 499. ISBN 978-0-471-35924-1. https://books.google.com/books?id=gWg-rchM700C&pg=PA499. 
  12. ↑ "raw material". Oxford English Dictionary. https://www.oed.com/search/dictionary/?scope=Entries&q=raw+material. Retrieved 20 September 2023. 
  13. ↑ Lagowski, J.J.; Mason, B.H.; Tayler, R.J. (16 August 2023). "chemical element". Encyclopedia Britannica. https://www.britannica.com/science/chemical-element. Retrieved 20 September 2023. 
  14. ↑ Ishizuki, Naoya; Shimizu, Ryota; Hitosugi, Taro (31 December 2023). "Autonomous experimental systems in materials science" (in en). Science and Technology of Advanced Materials: Methods 3 (1): 2197519. doi:10.1080/27660400.2023.2197519. ISSN 2766-0400. https://www.tandfonline.com/doi/full/10.1080/27660400.2023.2197519. 
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