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| ====1.1.1 Pathology====
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| [[File:Blood clot.jpg|right|thumb|Pathological view of a blood clot]]Pathology is at the heart of a medical laboratory's operations. In the context of modern medical treatment, the laboratory practice of pathology involves analytical workflow, which falls within the contemporary medical field of "general pathology," and the associated determination of the causes and effects of disease and other medical ailments. General pathology is broadly composed of a number of distinct but inter-related medical specialties that involve the analysis of tissue, cell, and body fluid specimens to better understand the cause, pathogenesis, morphologic changes, and clinical manifestations of a disease.<ref name="KumarRobbins09">{{cite book |title=Robbins and Cotran Pathologic Basis of Disease, Professional Edition |editor=Kumar, V.; Abbas, A.; Fausto, N.; Aster, J. |publisher=Saunders Elsevier |edition=8th |year=2010 |isbn=9781416031215}}</ref> In common medical practice, general pathology is mostly concerned with analyzing known clinical abnormalities that are markers or precursors for both infectious and non-infectious disease and is conducted by experts in one of two major specialties: [[anatomical pathology]] and [[clinical pathology]]. Additional subspecialties of pathology may further specialize in specific diseases (such as cancer) or situational focuses (such as cause of death).
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| '''1.1.1.1 Anatomical vs. clinical pathology''' | | ==''Introduction to Quality and Quality Management Systems''== |
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| | The goal of this short volume is to act as an introduction to the quality management system. It collects several articles related to quality, quality management, and associated systems. |
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| Anatomical (or "anatomic") pathology is a medical specialty of pathology that is concerned with the gross, microscopic, chemical, immunologic, and molecular examination of organs, tissues, and whole bodies (as in autopsy) to determine the presence of disease. Its subspecialties include surgical pathology (e.g., neuropathology, dermatopathology, etc.), cytopathology, and forensic pathology.<ref name="AdelmanForensic09">{{cite book |url=https://books.google.com/books?id=x5FftcZOv1UC&pg=PA3 |title=Forensic Medicine |author=Adelman, H.C. |publisher=Infobase Publishing |pages=3–4 |year=2009 |isbn=1438103816}}</ref> Clinical pathology, however, is concerned with the diagnosis of disease based on the laboratory analysis of bodily fluids such as blood, urine, and tissues using the tools of chemistry, microbiology, [[hematology]], and molecular analysis. Its subspecialties include hematopathology, immunopathology, and molecular pathology.<ref name="AdelmanForensic09" /> Both anatomical and clinical pathologists work in close collaboration with clinical scientists (i.e., clinical biochemists, clinical microbiologists, etc.), medical technologists, surgeons, [[hospital]] administrators, and referring physicians to ensure the accuracy and optimal utilization of laboratory testing. Yet some argue the distinction between anatomic and clinical pathology is increasingly blurred by the introduction of molecular technologies that require new expertise and the need to provide patients and referring physicians with integrated diagnostic reports.<ref name="FriedbergEvolv13">{{cite web |url=https://scholarlycommons.libraryinfo.bhs.org/all_works/7637/ |work=2013 Summer Anatomic Pathology Conference |title=Evolving Changes in Health Care and Implications for Pathology and Laboratory Practice |publisher=Florida Society of Pathologists |author=Friedberg, R. |quote=The advent of molecular pathology and molecular imaging tools only serves to further blur the distinction between anatomic and clinical pathology... |date=July 2013 |accessdate=18 November 2021}}</ref><ref name="PaxtonAllFor11">{{cite web |url=http://www.captodayonline.com/Archives/0211/0211a_cp_ap.html |title=All for one—unifying CP and AP data |author=Paxton, A. |work=CAP Today |quote=Traditionally, CP systems are based on discrete data elements while AP systems are based on blocks of text. But that distinction is starting to blur, because AP is moving to synoptic reporting, and that includes the creation of discrete data components as well as textual reporting |publisher=College of American Pathologists |date=February 2011 |accessdate=18 November 2021}}</ref>
| | ;1. What is quality? |
| | :''Key terms'' |
| | :[[Quality (business)|Quality]] |
| | :[[Quality assurance]] |
| | :[[Quality control]] |
| | :''The rest'' |
| | :[[Data quality]] |
| | :[[Information quality]] |
| | :[[Nonconformity (quality)|Nonconformity]] |
| | :[[Service quality]] |
| | ;2. Processes and improvement |
| | :[[Business process]] |
| | :[[Process capability]] |
| | :[[Risk management]] |
| | :[[Workflow]] |
| | ;3. Mechanisms for quality |
| | :[[Acceptance testing]] |
| | :[[Conformance testing]] |
| | :[[Clinical quality management system]] |
| | :[[Continual improvement process]] |
| | :[[Corrective and preventive action]] |
| | :[[Good manufacturing practice]] |
| | :[[Malcolm Baldrige National Quality Improvement Act of 1987]] |
| | :[[Quality management]] |
| | :[[Quality management system]] |
| | :[[Total quality management]] |
| | ;4. Quality standards |
| | :[[ISO 9000]] |
| | :[[ISO 13485]] |
| | :[[ISO 14000|ISO 14001]] |
| | :[[ISO 15189]] |
| | :[[ISO/IEC 17025]] |
| | :[[ISO/TS 16949]] |
| | ;5. Quality in software |
| | :[[Software quality]] |
| | :[[Software quality assurance]] |
| | :[[Software quality management]] |
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| Regardless, some differences between anatomical and clinical pathology remain distinct<ref name="ParkAnatom12">{{cite journal |title=Anatomic Pathology Laboratory Information Systems: A Review |journal=Advances in Anatomic Pathology |author=Park, S.L.; Pantanowitz, L.; Sharma, G. et al. |volume=19 |issue=2 |page=81–96 |year=2012 |doi=10.1097/PAP.0b013e318248b787 |pmid=22313836}}</ref>:
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| * Specific dictionary-driven tests are found in clinical pathology environments, but not so much in anatomic pathology environments.
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| * Ordered anatomic pathology tests typically require more [[information]] than clinical pathology tests.
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| * A single anatomic pathology order may be comprised of several tissues from several organs; clinical pathology orders usually do not.
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| * Anatomic pathology specimen collection may be a procedural, multi-step process, while clinical pathology specimen collection is routinely more simple.
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| The differences between the two may appear to be small, but a differentiation in laboratory workflow between the two is apparent, to the point that developers of [[laboratory information system]]s (LIS) and anatomic pathology computer systems used in the pathology fields have created different functionality for them. Specimen collection, receipt, and tracking; work distribution; and report generation may vary–sometimes significantly–between the two, requiring targeted functionality in the utilized software.<ref name="HenricksLIS12Arch">{{cite web |url=http://www.pathinformatics.pitt.edu/sites/default/files/2012Powerpoints/01HenricksTues.pdf |archiveurl=https://web.archive.org/web/20150910050825/http://www.pathinformatics.pitt.edu/sites/default/files/2012Powerpoints/01HenricksTues.pdf |format=PDF |title=LIS Basics: CP and AP LIS Design and Operations |work=Pathology Informatics 2012 |author=Henricks, W.H. |date=09 October 2012 |archivedate=10 September 2015 |accessdate=18 November 2021}}</ref><ref name="CliffordTheEvo11">{{cite web |url=https://www.mlo-online.com/home/article/13004085/the-evolving-lis-needs-to-be-everything-for-todays-laboratories |title=The evolving LIS needs to be "everything" for today's laboratories |author=Clifford, L.-J. |work=Medical Laboratory Observer |publisher=Endeavor Business Media, LLC |date=August 2011 |accessdate=18 November 2021}}</ref>
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| '''1.1.1.2 Forensic pathology'''
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| Typically associated with a medical examiner or coroner, forensic pathology is focused on identifying and determining the cause of death of an individual. This includes not only the analysis of wounds and injuries but also full tissue specimens, identifying traumas—as well as chemical, biological, and solid foreign bodies and contaminates—that may have played a role in the individual's death. Anatomic pathology plays an important part of the examiner's analyses—represented by the forensic pathologist's required training—though clinical pathology also plays a role.<ref name="PrahlowIntro">{{cite book |url=https://books.google.com/books?id=rF1WTiX0nHEC&pg=PA35 |chapter=Chapter 3: Introduction to Forensic Pathology |title=Forensic Pathology for Police, Death Investigators, Attorneys, and Forensic Scientists |author=Prahlow, J. |publisher=Humana Press |pages=35–48 |year=2010 |isbn=9781588299758 |doi=10.1007/978-1-59745-404-9}}</ref> Outside the gross examination of a body, the forensic pathologist will rely on the lab to conduct a variety of analyses. Whole organs and slides containing cross-sectional slivers of organs, as well as blood, urine, bile, and vitreous humor may be analyzed for toxicology, DNA typing, infectious diseases, disorders, or other chemical tests.<ref name="AACCTheWorld19">{{cite web |url=https://www.testing.com/articles/forensic-testing/ |title=The World of Forensic Laboratory Testing |work=Testing.com |publisher=OneCare Media |date=09 November 2021 |accessdate=18 November 2021}}</ref> In particular, maintaining chain of custody for such specimens is vital to ensure analyses are correct and evidence is not compromised. Though a medical laboratory, the forensic pathology laboratory isn't held to the same CLIA standards; they must be accredited by a related organization such as [[The American Society of Crime Laboratory Directors/Laboratory Accreditation Board]] to ensure the lab operates at prescribed standards.<ref name="AACCTheWorld19" />
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| ==References==
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| {{Reflist|colwidth=30em}}
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