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| =3. Additional resources for selecting and implementing informatics solutions - Part 3: Industry and community resources= | | ==This is demo code demoing math== |
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| ==3.6 Trade organizations==
| | As a typical example, from a [[calibration plot]] following a [[linear equation]] taken here as the simplest possible model: |
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| * [http://www.afronets.org/ African Networks for Health Research & Development (AFRO-NETS)]
| | : <math>f(x) = ax + b </math> |
| * [https://www.allianceni.org/ Alliance for Nursing Informatics (ANI)]
| |
| * [http://www.aaihds.org/ American Association of Integrated Healthcare Delivery Systems (AAIHDS)]
| |
| * [https://www.acla.com/ American Clinical Laboratory Association (ACLA)]
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| * [http://www.ahima.org/ American Health Information Management Association (AHIMA)]
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| * [http://www.ahimafoundation.org/ American Health Information Management Association (AHIMA) Foundation]
| |
| * [https://www.amia.org/ American Medical Informatics Association (AMIA)]
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| * [https://www.ania.org/ American Nursing Informatics Association (ANIA)]
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| * [https://www.ascld.org/ American Society of Crime Laboratory Directors (ASCLD)]
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| * [https://ashim.com/ American Society of Health Informatics Managers (ASHIM)]
| |
| * [https://www.americantelemed.org/ American Telemedicine Association (ATA)]
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| * [https://anab.ansi.org/laboratory-accreditation ANSI National Accreditation Board (ANAB)]
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| * [http://www.armtelemed.org/ Armenian Association of Telemedicine (AATM)]
| |
| * [https://www.apami.org/ Asia Pacific Association for Medical Informatics (APAMI)]
| |
| * [https://acdmglobal.org/ Association for Clinical Data Management (ACDM)]
| |
| * [https://www.pathologyinformatics.org/ Association for Pathology Informatics (API)]
| |
| * [https://www.avinformatics.org/ Association for Veterinary Informatics (AVI)]
| |
| * [http://www.clinicalscience.org/ Association of Clinical Scientists (ACS)]
| |
| * [https://amdis.org/ Association of Medical Directors of Information Systems (AMDIS)]
| |
| * [https://www.aphl.org/ Association of Public Health Laboratories (APHL)]
| |
| * [https://www.achi.org.au/ Australasian College of Health Informatics (ACHI)]
| |
| * [http://aths.org.au/ Australasian Telehealth Society (ATHS)]
| |
| * [http://www.ahiec.org.au/ Australian Health Informatics Education Council (AHIEC)]
| |
| <br />
| |
| * [https://www.bmia.be/ Belgian Medical Informatics Association (MIM)]
| |
| * [http://bii.in/ Bioinformatics Institute of India (BII)]
| |
| * [http://www.bioinformatics.org/ Bioinformatics Organization]
| |
| * [https://scotshi.bcs.org/ British Computer Society Health Scotland ]
| |
| <br />
| |
| * [https://www.echima.ca/ Canadian Health Information Management Association (CHIMA)]
| |
| * [https://cnia.ca/ Canadian Nursing Informatics Association (CNIA)]
| |
| * [https://www.aap.org/en-us/advocacy-and-policy/aap-health-initiatives/Informatics/Pages/Child-Health-Informatics-Center.aspx Child Health Informatics Center (CHIC)]
| |
| * [http://www.chiss.org.cn/ Chinese Health Information Standardization Society (CHISS)]
| |
| * [https://www.partners.org/Services/General/Research/Research-Technology/Clinical-Informatics-Research-and-Development.aspx Clinical Informatics Research and Development (CIRD)]
| |
| * [https://chimecentral.org/ College of Healthcare Information Management Executives (CHIME)]
| |
| * [https://www.cahiim.org/ Commission on Accreditation for Health Informatics and Information Management Education (CAHIIM)]
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| * [http://www.cola.org/ Commission on Office Laboratory Accreditation (COLA)]
| |
| * [http://www.cinc.org/about.shtml Computers in Cardiology]
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| * [https://services.aap.org/en/community/aap-councils/clinical-information-technology/ Council on Clinical Information Technology (COCIT)]
| |
| * [http://www.csbmili.cz/en Czech Society for Biomedical Engineering and Medical Informatics ( ČLS)]
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| <br /> | |
| * [https://digitalhealthcanada.com/ Digital Health Canada (DHC)]
| |
| <br /> | |
| * [http://www.entnet.jp/index-j.html Ear-Nose-Throat Informatics Society (ENTIS-J)]
| |
| * [http://www.ehealthinitiative.org/ eHealth Initiative (eHI)]
| |
| * [https://www.embnet.org/ EMBnet - The Global Bioinformatics Network]
| |
| * [http://emergencyinformatics.org/ Emergency Informatics Association (EIA)]
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| * [https://efmi.org/ European Federation for Medical Informatics (EFMI)]
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| * [https://www.ehtel.eu/ European Health Telematics Association (EHTEL)]
| |
| * [https://www.ercim.eu/ European Research Consortium for Informatics and Mathematics (ERCIM)]
| |
| * [http://aimedicine.info/aime/ European Society for Artificial Intelligence in Medicine (AIME)]
| |
| * [http://www.eurorec.org/ EUROREC Institute]
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| <br />
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| * [http://fedip.org/ Federation for Informatics Professionals (FEDIP)]:
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| * [http://fhts.ac.in/ Foundation of Healthcare Technologies Society (FHTS)]
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| <br />
| |
| * [https://www.who.int/goe/en/ Global Observatory for eHealth (GOE)]
| |
| * [https://www.mygoblet.org/ Global Organisation for Bioinformatics Learning, Education & Training (GOBLET)]
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| <br />
| |
| * [https://www.helina-online.org/ Health Informatics in Africa (HELINA)]
| |
| * [https://www.hinz.org.nz/ Health Informatics New Zealand (HINZ)]
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| * [https://www.hisa.org.au/ Health Informatics Society of Australia (HISA)]
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| * [http://www.his.org.ng/ Health Informatics Society of Nigeria (HISN)]
| |
| * [https://himaa.org.au/ Health Information Management Association of Australia (HIMAA)]
| |
| * [http://www.hl7.org/ Health Level Seven International (HL7)]
| |
| * [https://www.hon.ch/en/ Health On the Net Foundation (HON)]
| |
| * [https://www.hisi.ie/ Healthcare Informatics Society of Ireland (HISI)]
| |
| * [https://www.himss.org/ Healthcare Information and Management Systems Society (HIMSS)]
| |
| * [https://www.ehra.org/ HIMSS EHR Association (HIMSS EHRA)]
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| <br />
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| * [https://www.embs.org/ IEEE Engineering in Medicine and Biology Society (IEEE EMBS)]
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| * [https://www.ihe.net/ IHE International]
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| * [https://www.iami.org.in/ Indian Association for Medical Informatics (IAMA)]
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| * [http://www.ipab.org/ Initiative for Parallel Bioinformatics (IPAB)]
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| * [https://www.ihrim.co.uk/ Institute of Health Records & Information Management (IHRIM)]
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| * [https://ifhima.org/ International Federation of Health Information Management Associations (IFHIMA)]
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| * [https://www.ihtsdo.org/ International Health Terminology Standards Development Organisation (IHTSDO)]
| |
| * [https://imia-medinfo.org/ International Medical Informatics Association (IMIA)]
| |
| * [https://www.isber.org/ International Society for Biological and Environmental Repositories (ISBER)]
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| * [http://www.iscb.info/ International Society for Clinical Biostatistics (ISCB)]
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| * [http://www.iscb.org/ International Society for Computational Biology (ISCB)]
| |
| * [https://www.iqvia.com/insights/the-iqvia-institute IQVIA Institute for Human Data Science]
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| <br />
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| * [http://www.jami.jp/english/ Japan Association for Medical Informatics (JAMI)]
| |
| * [https://www.jami-ni.jp/ Japan Association for Medical Informatics - Nursing Informatics (JAMI-NI)]
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| * [https://jcls.or.jp/ Japan Association for Clinical Laboratory Science (JCLS)]
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| * [http://www.jhim-e.jp/ Japan Society of Health Information Management (JHIM)]
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| * [https://www.jsbi.org/ Japanese Society for Bioinformatics (JSBi)]
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| * [https://www.jasdi.jp/ Japanese Society of Drug Informatics (JASDI)]
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| <br />
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| * [http://kehia.org/ Kenya Health Informatics Association (KeHIA)]
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| <br />
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| * [http://www.lrig.org/ Laboratory Research & Innovation Group (LRIG)]
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| <br />
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| * [https://www.markle.org/ Markle Foundation]
| |
| * [http://www.mcsiindia.com/ Medical Computer Society of India (MCSI)]
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| * [http://www.meditac.com/ Medical Informatics and Technology Applications Consortium (MedITAC)]
| |
| * [https://www.mlanet.org/ Medical Library Association (MLA)]
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| * [https://msia.com.au/ Medical Software Industry Association (MSIA)]
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| * [https://www.medtecheurope.org/ MedTech Europe]
| |
| * [https://www.meahi.org/ Middle East Association for Health Informatics (MEAHI)]
| |
| <br />
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| * [https://nationalacademies.org/ National Academies]
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| * [https://www.nahdo.org/ National Association of Health Data Organizations (NAHDO)]
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| * [http://www.nihi.ca/ National Institutes of Health Informatics (NIHI)]
| |
| * [https://nelac-institute.org/index.php The NELAC Institute]
| |
| * [https://www.nenic.org/ New England Nursing Informatics Consortium (NENIC)]
| |
| * [https://www.bcs.org/membership/member-communities/nursing-specialist-group/ Nursing Specialist Group (NSG)]
| |
| <br />
| |
| * [https://onig.on.ca/ Ontario Nursing Informatics Group (ONIG)]
| |
| * [http://www.openclinical.org/ OpenClinical]
| |
| * [https://www.openehr.org/about/vision_and_mission openEHR Foundation]
| |
| * [http://oscarcanada.org/usersgroups/oscarcanada-users-society OSCAR Canada Users' Society (OCUS)]
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| <br />
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| * [https://phii.org/ Public Health Informatics Institute (PHII)]
| |
| <br />
| |
| * [http://www.enfermeriainformaticalac.org/ Red Internacional de Enfermería Informática (RIEI)]
| |
| * [https://www.regenstrief.org/ Regenstrief Institute]
| |
| <br />
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| * [https://siim.org/ Society for Imaging Informatics in Medicine (SIIM)]
| |
| * [https://slas.org/ Society for Laboratory Automation and Screening (SLAS)]
| |
| * [https://sfmi.stretchcloud.se/ Swedish Association of Medical Informatics (SFMI)]
| |
| * [https://www.sib.swiss/ Swiss Institute of Bioinformatics (SIB)]
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| <br />
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| * [http://uacm.kharkov.ua/eng/index.html Ukrainian Association for Computer Medicine (UACM)]
| |
| * [https://www.umin.ac.jp/english/ University hospital Medical Information Network (UMIN)]
| |
| * https://www.urac.org/ URAC]
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| <br />
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| * [http://www.vanbug.org/ Vancouver Bioinformatics Users Group (VanBUG)]
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| <br />
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| * [http://www.wfmc.org/ Workflow Management Coalition (WfMC)]
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|
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| ==3.7 Conferences and trade shows==
| | where, <math>f(x)</math> corresponds to the signal measured (e.g. voltage, luminescence, energy, etc.) |
| ====Conferences====
| |
| {{Resources/Conferences}}
| |
| | |
| ====Trade shows====
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| {{Resources/Trade shows}}
| |
| | |
| ==3.8 User communities==
| |
| * [https://www.aapc.com/discuss/ AAPC Medical Billing and Coding Forum]
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| * [http://www.americanehr.com/Home.aspx AmericanEHR]
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| * [https://connect.ascls.org/communities/redirectopenforum ASCLS Open Forum]
| |
| * [https://www.linkedin.com/groups/1058857/ BCS Health Informatics Forum on LinkedIn]
| |
| * [https://yfsf.aafs.org/resources/professional-discussion-lists/ Forens-L Email Discussion List]
| |
| * [https://healthinformaticsforum.com/ Health Informatics Forum]
| |
| * [https://www.iami.org.in/ IAMA Email Discussion Lists]
| |
| * [https://www.jiscmail.ac.uk/ JISCMail's industry-specific mailing lists]
| |
| * [https://loinc.org/forums/forum/laboratory-loinc/ Laboratory LOINC]
| |
| * [https://www.linkedin.com/groups/705/ Laboratory Research & Innovation Group on LinkedIn]
| |
| * [http://www.labwrench.com/ LabWrench]
| |
| * [https://www.linkedin.com/groups/36640/ LIMS/Laboratory Informatics group on LinkedIn]
| |
| * [https://www.limsforum.com/ LIMSforum]
| |
| * [https://www.pathlabtalk.com/forum/ PathLabTalk]
| |
| | |
| ===Reddit-based communities===
| |
| * [https://www.reddit.com/r/healthIT/ /r/healthIT]
| |
| * [https://www.reddit.com/r/labrats/ /r/labrats]
| |
| * [https://www.reddit.com/r/medlabprofessionals/ /r/MedLabProfessionals]
| |
| | |
| ==3.9 Books and journals==
| |
| ===Books===
| |
| Hundred of books concerning medical- and research-based laboratory science—as well as laboratory informatics—have been published over the past several decades. As such, it's difficult to make specific recommendations, at least without context. However, professional organizations are quite proficient in making such recommendations through their reading libraries and accreditation programs. For example, the Canadian Society for Medical Laboratory Science maintains a [https://www.csmls.org/csmls/media/documents/certification/CEXM-359-F2-Textbook-Reference-List-General-Medical-Laboratory-Technology.pdf three-page list] of reference textbooks that are useful for their Medical Laboratory Technologist examination. The American Society for Clinical Pathology has its own [https://store.ascp.org/ publication division], with more than 60 in-house books published on various elements of pathology and laboratory science. The American Association for Clinical Chemistry has [https://www.aacc.org/publications/books-and-multimedia a similar library], as does the [https://apha.org/publications-and-periodicals/published-books American Public Health Association], the [https://www.asmscience.org/content/books?order=date American Society for Microbiology], and the [https://www.acponline.org/clinical-information/journals-publications/books-from-acp American College of Physicians].
| |
| | |
| For medical informatics books, you could turn to the community recommendations made over at the [https://healthinformaticsforum.com/page/health-informatics-books Health Informatics Forum]. The Amazon-associated BookAuthority has a [https://bookauthority.org/books/best-health-informatics-books section for medical informatics], though it's not clear how rigorous their ratings system is. Universities such as the [https://researchguides.uic.edu/c.php?g=252330&p=1683330 University of Illinois-Chicago] also may offer book recommendations.
| |
| | |
| ===Journals===
| |
| {{Resources/Journals}}
| |
| | |
| ==3.10 Standards, regulations, and guidance==
| |
| ===Accreditation requirements===
| |
| {|
| |
| | STYLE="vertical-align:top;"|
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| {| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0" width="80%"
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| |-
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| ! colspan="3" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"|
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| |-
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| ! style="color:brown; background-color:#ffffee;"|Accreditation requirement
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| ! style="color:brown; background-color:#ffffee;"|Description
| |
| ! style="color:brown; background-color:#ffffee;"|Relevant medical or research field(s)
| |
| |-
| |
| | style="padding:5px; width:350px;" |[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL]
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| | style="padding:10px; background-color:white;" |the laboratory accreditation requirements for the American Association of Veterinary Laboratory Diagnosticians
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| | style="padding:10px; background-color:white;" |Veterinary medicine
| |
| |-
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| | style="padding:5px; width:350px;" |[http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual]
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| | style="padding:10px; background-color:white;" |the laboratory accreditation requirements for the American Board of Forensic Toxicology
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| | style="padding:10px; background-color:white;" |Forensic medicine - toxicology
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| |-
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| | style="padding:5px; width:350px;" |[https://www.aihaaccreditedlabs.org/Policies/Pages/default.aspx AIHA-LAP Policies 2018]
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| | style="padding:10px; background-color:white;" |the laboratory accreditation requirements for the American Industrial Hygiene Association
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| | style="padding:10px; background-color:white;" |Microbiology - environmental
| |
| |-
| |
| | style="padding:5px; width:350px;" |[http://des.wa.gov/sites/default/files/public/documents/About/1063/RFP/Add7_Item4ASCLD.pdf ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories]
| |
| | style="padding:10px; background-color:white;" |the laboratory accreditation requirements for the American Society of Crime Laboratory Directors / Laboratory Accreditation Board; NOTE: ASCLD/LAB has since merged with the ANSI National Accreditation Board ([https://anab.ansi.org/ ANAB])
| |
| | style="padding:10px; background-color:white;" |Forensic medicine
| |
| |-
| |
| | style="padding:5px; width:350px;" |[https://www.scribd.com/document/324645876/COLA-Laboratory-Accreditation-Manual COLA Laboratory Accreditation Standards]
| |
| | style="padding:10px; background-color:white;" |the laboratory accreditation requirements of the [http://www.cola.org/lab-testing-accreditation-quality/what-is-cola/ Commission on Office Laboratory Accreditation]
| |
| | style="padding:10px; background-color:white;" |See description
| |
| |-
| |
| | style="padding:5px; width:350px;" |[https://www.jointcommissioninternational.org/en/accreditation/accreditation-programs/laboratory/ JCI Laboratory Accreditation Standards]
| |
| | style="padding:10px; background-color:white;" |the laboratory accreditation requirements for the Joint Commission International; applicable to microbiology, clinical chemistry, hematology, blood banking and transfusion, cytogentics, and immunology/serology labs
| |
| | style="padding:10px; background-color:white;" |See description
| |
| |-
| |
| | style="padding:5px; width:350px;" |[https://www.wadsworth.org/sites/default/files/WebDoc/CLEP-Program-Guide-Nov2019.pdf NYS Department of Health - Clinical Laboratory Evaluation Program]
| |
| | style="padding:10px; background-color:white;" |the laboratory accreditation requirements for New York State's "clinical laboratories and blood banks, including out-of-state facilities that accept clinical specimens collected in New York State"
| |
| | style="padding:10px; background-color:white;" |See description
| |
| |-
| |
| |}
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| |}
| |
| | |
| ===Guidelines and recommendations===
| |
| {|
| |
| | STYLE="vertical-align:top;"|
| |
| {| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0" width="80%"
| |
| |-
| |
| ! colspan="3" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"|
| |
| |-
| |
| ! style="color:brown; background-color:#ffffee;"|Guideline/Recommendation
| |
| ! style="color:brown; background-color:#ffffee;"|Description
| |
| ! style="color:brown; background-color:#ffffee;"|Relevant medical or research field(s)
| |
| |-
| |
| | style="padding:5px; width:350px;" |[https://www.acmg.net/ACMG/Medical-Genetics-Practice-Resources/Technical_Standards_and_Guidelines.aspx ACMG Standards and Guidelines for Clinical Genetics Laboratories]
| |
| | style="padding:10px; background-color:white;" |guidelines from the American College of Medical Genetics on the laboratory "use of molecular techniques to examine heritable changes in the human genome"; a more recent version (2014) exists but may only be available to ACMG members
| |
| | style="padding:10px; background-color:white;" |Genetic diagnostics
| |
| |-
| |
| | style="padding:5px; width:350px;" |[https://www.aphl.org/aboutAPHL/publications/Documents/WORK_BlueBook.pdf APHL Clinical Laboratory Preparedness and Response Guide]
| |
| | style="padding:10px; background-color:white;" |guidelines from the Association of Public Health Laboratories and the American Society for Microbiology on clinical (and any other) laboratories handling microorganisms and toxins of elevated risk to human health and public safety
| |
| | style="padding:10px; background-color:white;" |Any
| |
| |-
| |
| | style="padding:5px; width:350px;" |[https://www.asm.org/ASM/media/Policy-and-Advocacy/Biosafety_Sentinel_Guideline_October_2018_FINAL.pdf ASM Sentinel Level Clinical Laboratory Guidelines for Suspected Agents of Bioterrorism and Emerging Infectious Diseases]
| |
| | style="padding:10px; background-color:white;" |guidelines from the American Society for Microbiology on clinical (and any other) laboratories handling microorganisms and toxins of elevated risk to human health and public safety
| |
| | style="padding:10px; background-color:white;" |Any
| |
| |-
| |
| | style="padding:5px; width:350px;" |[https://www.cdc.gov/mmwr/pdf/other/su6101.pdf CDC Guidelines for Safe Work Practices in Human and Animal Medical Diagnostic Laboratories]
| |
| | style="padding:10px; background-color:white;" |guidelines from the Centers for Disease Control and Prevention on biosafety practices in clinical diagnostic laboratories working with human and animal specimens
| |
| | style="padding:10px; background-color:white;" |Any
| |
| |-
| |
| | style="padding:5px; width:350px;" |[https://www.cdc.gov/phin/tools/phinms/index.html CDC PHIN Messaging System]
| |
| | style="padding:10px; background-color:white;" |guidelines from the Centers for Disease Control and Prevention on using the Public Health Information Network Messaging System
| |
| | style="padding:10px; background-color:white;" |Public health
| |
| |-
| |
| | style="padding:5px; width:350px;" |[https://www.niaid.nih.gov/sites/default/files/gclp.pdf DAIDS Guidelines for Good Clinical Laboratory Practice Standards]
| |
| | style="padding:10px; background-color:white;" |GLP guidelines from the NIH's Division of AIDS (DAIDS) for clinical research laboratories conducting testing that supports a clinical trial sponsored by DAIDS
| |
| | style="padding:10px; background-color:white;" |Clinical research
| |
| |-
| |
| | style="padding:5px; width:350px;" |[https://www.icar.org/Guidelines/15-Data-Exchange.pdf ICAR 15 Data Exchange]
| |
| | style="padding:10px; background-color:white;" |guidelines from the International Committee for Animal Recording for data management and transfer of animal data; though rare, may apply to the occasional veterinary laboratory
| |
| | style="padding:10px; background-color:white;" |Veterinary medicine
| |
| |-
| |
| | style="padding:5px; width:350px;" |[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4]
| |
| | style="padding:10px; background-color:white;" |recommendations in the form of information security and privacy controls from the National Institute of Standards and Technology; these cybersecurity controls apply to federal systems, though they can be applied to non-federal systems just as readily
| |
| | style="padding:10px; background-color:white;" |Any
| |
| |-
| |
| | style="padding:5px; width:350px;" |[https://www.who.int/tdr/publications/documents/gclp-web.pdf?ua=1 WHO Good Clinical Laboratory Practice]
| |
| | style="padding:10px; background-color:white;" |guidelines from the World Health Organization (WHO) for organizations performing testing for clinical trials as part of good clinical practice
| |
| | style="padding:10px; background-color:white;" |Clinical research
| |
| |-
| |
| |}
| |
| |}
| |
| | |
| ===Regulations and legal requirements===
| |
| {|
| |
| | STYLE="vertical-align:top;"|
| |
| {| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0" width="80%"
| |
| |-
| |
| ! colspan="3" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"|
| |
| |-
| |
| ! style="color:brown; background-color:#ffffee;"|Regulation or legal requirement
| |
| ! style="color:brown; background-color:#ffffee;"|Description
| |
| ! style="color:brown; background-color:#ffffee;"|Relevant medical or research field(s)
| |
| |-
| |
| | style="padding:5px; width:350px;" |[https://www.law.cornell.edu/cfr/text/5/930.301 5 CFR Part 930.301]
| |
| | style="padding:10px; background-color:white;" |U.S. Code of Federal Regulation 5 CFR § 930.301 Information systems security awareness training program; this would affect medical diagnostic and research laboratories housed in executive agencies of the U.S. government, e.g., National Institutes of Health and Federal Bureau of Investigation
| |
| | style="padding:10px; background-color:white;" |See description
| |
| |-
| |
| | style="padding:5px; width:350px;" |[https://www.law.cornell.edu/cfr/text/9/part-121 9 CFR Part 121]
| |
| | style="padding:10px; background-color:white;" |U.S. Code of Federal Regulation 9 CFR § 121 Possession, Use, and Transfer of Select Agents and Toxins; this would affect medical diagnostic and research laboratories interacting with specific biological agents and toxins that pose a threat to public and animal health and safety
| |
| | style="padding:10px; background-color:white;" |See description
| |
| |-
| |
| | style="padding:5px; width:350px;" |[https://www.law.cornell.edu/uscode/text/18/220 18 U.S. Code Part 220] aka EKRA
| |
| | style="padding:10px; background-color:white;" |18 U.S. Code § 220 Illegal remunerations for referrals to recovery homes, clinical treatment facilities, and laboratories; aka EKRA, this affects all laboratories and their sales and contracting activities, prohibiting kickbacks and payments based on number of referrals or tests, or the amount billed (and yes, this is [https://mcdonaldhopkins.com/Insights/Alerts/2020/01/27/EKRA-enforcement-after-a-year-of-uncertainty getting prosecuted])
| |
| | style="padding:10px; background-color:white;" |Any
| |
| |-
| |
| | style="padding:5px; width:350px;" |[https://www.law.cornell.edu/cfr/text/21/part-11 21 CFR Part 11]
| |
| | style="padding:10px; background-color:white;" |U.S. Code of Federal Regulation 21 CFR § 11 Electronic Records and Signatures; this would affect medical diagnostic and research laboratories of all types interacting with electronic records
| |
| | style="padding:10px; background-color:white;" |Any
| |
| |-
| |
| | style="padding:5px; width:350px;" |[https://www.law.cornell.edu/cfr/text/21/part-606 21 CFR Part 606]
| |
| | style="padding:10px; background-color:white;" |U.S. Code of Federal Regulation 21 CFR § 606 Current Good Manufacturing Practice for Blood and Blood Components; this would affect medical laboratories collecting, processing, testing, storing, and distributing blood and blood components
| |
| | style="padding:10px; background-color:white;" |Blood banking and transfusion medicine
| |
| |-
| |
| | style="padding:5px; width:350px;" |[https://www.law.cornell.edu/cfr/text/21/part-812 21 CFR Part 812]
| |
| | style="padding:10px; background-color:white;" |U.S. Code of Federal Regulation 21 CFR § 812 Investigational Device Exemptions; this would affect central and contract research laboratories conducting clinical investigations of medical devices
| |
| | style="padding:10px; background-color:white;" |Clinical research
| |
| |-
| |
| | style="padding:5px; width:350px;" |[https://www.law.cornell.edu/cfr/text/29/1910.1030 29 CFR Part 1910.1030]
| |
| | style="padding:10px; background-color:white;" |U.S. Code of Federal Regulation 29 CFR § 1910.1030 Bloodborne pathogens; this would affect medical diagnostic and research laboratories of all types that have occupational exposure risk to blood or other potentially infectious materials
| |
| | style="padding:10px; background-color:white;" |See description
| |
| |-
| |
| | style="padding:5px; width:350px;" |[https://www.law.cornell.edu/cfr/text/29/1910.1096 29 CFR Part 1910.1096]
| |
| | style="padding:10px; background-color:white;" |U.S. Code of Federal Regulation 29 CFR § 1910.1096 Ionizing radiation; this would affect medical diagnostic and research laboratories of all types that have occupational exposure risk to ionizing radiation sources such as x-rays, CT or CAT scans, PET scans, fluoroscopy, or any nuclear medicine procedures
| |
| | style="padding:10px; background-color:white;" |See description
| |
| |-
| |
| | style="padding:5px; width:350px;" |[https://www.law.cornell.edu/cfr/text/29/1910.1200 29 CFR Part 1910.1200]
| |
| | style="padding:10px; background-color:white;" |U.S. Code of Federal Regulation 29 CFR § 1910.1200 Hazard communication; this would affect medical diagnostic and research laboratories of all types that have occupational exposure risk to hazardous chemicals, requiring proper notification of the hazards the chemicals pose
| |
| | style="padding:10px; background-color:white;" |See description
| |
| |-
| |
| | style="padding:5px; width:350px;" |[https://www.law.cornell.edu/cfr/text/29/1910.1450 29 CFR Part 1910.1450]
| |
| | style="padding:10px; background-color:white;" |U.S. Code of Federal Regulation 29 CFR § 1910.1450 Occupational exposure to hazardous chemicals in laboratories; this would affect medical diagnostic and research laboratories of all types that have occupational exposure risk to hazardous chemicals, requiring proper procedures and record-keeping related to workplace chemicals
| |
| | style="padding:10px; background-color:white;" |See description
| |
| |-
| |
| | style="padding:5px; width:350px;" |[https://www.law.cornell.edu/cfr/text/42/part-73 42 CFR Part 73]
| |
| | style="padding:10px; background-color:white;" |U.S. Code of Federal Regulation 42 CFR § 73 Select Agents and Toxins; this would affect medical diagnostic and research laboratories "that possess SARS-CoV, Lujo virus, or Chapare virus"
| |
| | style="padding:10px; background-color:white;" |See description
| |
| |-
| |
| | style="padding:5px; width:350px;" |[https://www.law.cornell.edu/cfr/text/42/part-493 42 CFR Part 493] aka CLIA Regulations
| |
| | style="padding:10px; background-color:white;" |U.S. Code of Federal Regulation 42 CFR § 493 Laboratory Requirements aka CLIA Regulations; this would affect all medical diagnostic laboratories and apply to [https://www.dfhcc.harvard.edu/crs-resources/OHRS_Documents/02_-_Investigator_Resources/IS_-_Guidance_-_CLIA_Requirements.pdf select medical research laboratories]
| |
| | style="padding:10px; background-color:white;" |See description
| |
| |-
| |
| | style="padding:5px; width:350px;" |[https://www.law.cornell.edu/cfr/text/45/part-160 45 CFR Part 160] aka HIPAA Regulations
| |
| | style="padding:10px; background-color:white;" |U.S. Code of Federal Regulation 45 CFR § 160 General Administrative Requirements aka HIPAA Regulations; this would affect any medical diagnostic and research laboratory "who transmits any health information in electronic form"
| |
| | style="padding:10px; background-color:white;" |See description
| |
| |-
| |
| | style="padding:5px; width:350px;" |[https://www.law.cornell.edu/cfr/text/45/part-164 45 CFR Part 164] aka HIPAA Regulations
| |
| | style="padding:10px; background-color:white;" |U.S. Code of Federal Regulation 45 CFR § 164 Security and Privacy aka HIPAA Regulations; this would affect any medical diagnostic and research laboratory "who transmits any health information in electronic form"
| |
| | style="padding:10px; background-color:white;" |See description
| |
| |-
| |
| | style="padding:5px; width:350px;" |[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy]
| |
| | style="padding:10px; background-color:white;" |U.S. Department of Justice's Criminal Justice Information Services Security Policy; this mandates the provision of "appropriate controls to protect the full life cycle of Criminal Justice Information" for "all entities with access to, or who operate in support of, FBI CJIS Division’s services and information"
| |
| | style="padding:10px; background-color:white;" |Forensic medicine (see description)
| |
| |-
| |
| | style="padding:5px; width:350px;" |[https://www.lighthouselabservices.com/state-license/ U.S. state-specific laboratory licensing regulations]
| |
| | style="padding:10px; background-color:white;" |an online U.S. state licensing map by Lighthouse Lab Services which links to state-specific licensing requirements and laws
| |
| | style="padding:10px; background-color:white;" |Any
| |
| |-
| |
| |}
| |
| |}
| |
| | |
| ===Standards and specifications===
| |
| Though not listed below, the Clinical and Laboratory Standards Institute (CLSI) has a mountain of standards for laboratories (though pricey). There are too many to list here, so see their standards repository [https://clsi.org/standards/ on their website]. Similarly, ASTM International has many other informatics standards that may apply to laboratories. See their [https://www.astm.org/COMMIT/SUBCOMMIT/E13.htm Committee E13 on Molecular Spectroscopy and Separation Science] and [https://www.astm.org/COMMIT/SUBCOMMIT/E31.htm Committee E31 on Healthcare Informatics] for more standards.
| |
| | |
| {|
| |
| | STYLE="vertical-align:top;"|
| |
| {| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0" width="80%"
| |
| |-
| |
| ! colspan="3" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"|
| |
| |-
| |
| ! style="color:brown; background-color:#ffffee;"|Standard or specification
| |
| ! style="color:brown; background-color:#ffffee;"|Description
| |
| ! style="color:brown; background-color:#ffffee;"|Relevant medical or research field(s)
| |
| |-
| |
| | style="padding:5px; width:350px;" |[https://www.astm.org/Standards/E1188.htm ASTM E1188-11]
| |
| | style="padding:10px; background-color:white;" |ASTM International's ASTM E1188-11 Standard Practice for Collection and Preservation of Information and Physical Items by a Technical Investigator; describes best practices for the "collection and preservation of evidence for further analysis"
| |
| | style="padding:10px; background-color:white;" |Forensic medicine
| |
| |-
| |
| | style="padding:5px; width:350px;" |[https://www.astm.org/Standards/E1459.htm ASTM E1459-13]
| |
| | style="padding:10px; background-color:white;" |ASTM International's ASTM E1459-13 Standard Guide for Physical Evidence Labeling and Related Documentation; describes best practices for managing chain of custody for physical evidence
| |
| | style="padding:10px; background-color:white;" |Forensic medicine
| |
| |-
| |
| | style="padding:5px; width:350px;" |[https://www.astm.org/Standards/E1492.htm ASTM E1492-11]
| |
| | style="padding:10px; background-color:white;" |ASTM International's ASTM E1492-11 Standard Practice for Receiving, Documenting, Storing, and Retrieving Evidence in a Forensic Science Laboratory; describes best practices for physical evidence management in order to protect the chain of custody for the evidence
| |
| | style="padding:10px; background-color:white;" |Forensic medicine
| |
| |-
| |
| | style="padding:5px; width:350px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18]
| |
| | style="padding:10px; background-color:white;" |ASTM International's ASTM E1578-18 Standard Guide for Laboratory Informatics; provides educational guidance on the many aspects of laboratory informatics, including "issues commonly encountered at all stages in the life cycle" of such systems
| |
| | style="padding:10px; background-color:white;" |Any
| |
| |-
| |
| | style="padding:5px; width:350px;" |[https://www.dicomstandard.org/current/ DICOM Standard]
| |
| | style="padding:10px; background-color:white;" |the National Electrical Manufacturers Association's (NEMA) Digital Imaging and Communications in Medicine standard "to transmit, store, retrieve, print, process, and display medical imaging information"
| |
| | style="padding:10px; background-color:white;" |Various
| |
| |-
| |
| | style="padding:5px; width:350px;" |[https://www.who.int/classifications/icd/en/ ICD-10 and 11 Standard]
| |
| | style="padding:10px; background-color:white;" |the World Health Organization's (WHO) International Classification of Diseases standard for reporting diseases and health conditions; ICD-11 goes into effect 01 January 2022
| |
| | style="padding:10px; background-color:white;" |Various
| |
| |-
| |
| | style="padding:5px; width:350px;" |[https://www.iso.org/standard/56115.html ISO 15189:2012]
| |
| | style="padding:10px; background-color:white;" |International Organization for Standardization's ISO 15189:2012 Medical laboratories — Requirements for quality and competence; this standard "specifies requirements for quality and competence in medical laboratories" and is used for developing quality management systems and confirming laboratory competency
| |
| | style="padding:10px; background-color:white;" |Any
| |
| |-
| |
| | style="padding:5px; width:350px;" |[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017]
| |
| | style="padding:10px; background-color:white;" |International Organization for Standardization's ISO 17025:2017 General requirements for the competence of testing and calibration laboratories; this standard "specifies the general requirements for the competence, impartiality and consistent operation of laboratories" and is used for assuaging others to the competence of the lab
| |
| | style="padding:10px; background-color:white;" |Any
| |
| |-
| |
| | style="padding:5px; width:350px;" |[https://loinc.org/ LOINC Standard]
| |
| | style="padding:10px; background-color:white;" |the Regenstrief Institute's Logical Observation Identifiers Names and Codes standard, "a common language (a set of identifiers, names, and codes) for identifying health measurements, observations, and documents"
| |
| | style="padding:10px; background-color:white;" |Various
| |
| |-
| |
| | style="padding:5px; width:350px;" |[https://www.aphis.usda.gov/animal_health/nahln/downloads/MessagingQuickGuide.pdf NAHLN HL7 Messaging Quick User Guide]
| |
| | style="padding:10px; background-color:white;" |The Veterinary Terminology Services Laboratory, part of the Virginia-Maryland Regional College of Veterinary Medicine, and its [https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/lab-info-services/nahln/ct_nahln_it National Animal Health Laboratory Network] (NAHLN) HL7 Messaging standards; this user guide provides the participating veterinary laboratory assistance on using the HL7 messaging protocol and NAHLN standards in order to transmit data
| |
| | style="padding:10px; background-color:white;" |Veterinary medicine
| |
| |-
| |
| | style="padding:5px; width:350px;" |[https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYS Department of Health Clinical Laboratory Standards of Practice]
| |
| | style="padding:10px; background-color:white;" |The New York State Department of Health, Wadsworth Center's Clinical Laboratory Standards of Practice; this is a two-part collection of laboratory standards for NYS labs and those non-NYS labs that handle specimens originating in NYS, though these standards could effectively be applied by any medical laboratory; includes standards for specialty laboratories
| |
| | style="padding:10px; background-color:white;" |Any
| |
| |-
| |
| | style="padding:5px; width:350px;" |[http://www.snomed.org/ SNOMED CT]
| |
| | style="padding:10px; background-color:white;" |SNOMED International's Systematized Nomenclature of Medicine Clinical Terms standard, for standardized medical terminology
| |
| | style="padding:10px; background-color:white;" |Various
| |
| |-
| |
| | style="padding:5px; width:350px;" |[http://venomcoding.org/ U.S. National Library of Medicine UMLS]
| |
| | style="padding:10px; background-color:white;" |the Unifeid Medical Language System (UMLS), which "integrates and distributes key terminology, classification and coding standards, and associated resources to promote creation of more effective and interoperable biomedical information systems and services"
| |
| | style="padding:10px; background-color:white;" |Various
| |
| |-
| |
| | style="padding:5px; width:350px;" |[http://venomcoding.org/ VeNom Coding Group terminology]
| |
| | style="padding:10px; background-color:white;" |VeNom Coding Group's VeNom Veterinary Nomenclature; this is a standardized veterinary terminology "for use in referral veterinary hospital electronic patient records and first opinion veterinary practice management systems"
| |
| | style="padding:10px; background-color:white;" |Veterinary medicine
| |
| |-
| |
| | style="padding:5px; width:350px;" |[https://vtsl.vetmed.vt.edu/ Veterinary Terminology Services Laboratory terminology options]
| |
| | style="padding:10px; background-color:white;" |The Veterinary Terminology Services Laboratory, part of the Virginia-Maryland Regional College of Veterinary Medicine, and its standardized terminology resources; the VTSL maintains a variety of standardized veterinary terminologies, including "the Veterinary Extension to SNOMED CT as well as subsets for the National Animal Health Laboratory Network, AAHA Diagnostic Terms and AAEP Diagnostic Terms"
| |
| | style="padding:10px; background-color:white;" |Veterinary medicine
| |
| |-
| |
| |}
| |
| |}
| |
| | |
| ==3.11 LIMSpec==
| |
| [[Book:LIMSpec 2019 R1|LIMSpec]] is an ever-evolving set of software user requirements specifications for laboratory informatics systems. The specification has grown significantly from its humble origins over a decade ago. Earlier versions of LIMSpec focused on a mix of both regulatory requirements and clients' "wishlist" features for a given system. The wishlist items haven't necessarily been ignored by developers, but they do in fact have to be prioritized by the potential buyer as "nice to have" or "essential to system operation," or something in between.<ref name="AasemAnalysis10">{{cite journal |title=Analysis and optimization of software requirements prioritization techniques |author=Aasem, M.; Ramzan, M.; Jaffar, A. |journal=Proceedings from the 2010 International Conference on Information and Emerging Technologies |pages=1–6 |year=2010 |doi=10.1109/ICIET.2010.5625687}}</ref><ref name="Hirsch10Steps13">{{cite web |url=https://www.phase2technology.com/blog/successful-requirements-gathering |title=10 Steps To Successful Requirements Gathering |author=Hirsch, J. |publisher=Phase2 Technology, LLC |date=22 November 2013 |accessdate=02 February 2020}}</ref><ref name="BurrissSoftware07">{{cite web |url=http://sce2.umkc.edu/BIT/burrise/pl/requirements/ |archiveurl=https://web.archive.org/web/20190724173601/http://sce2.umkc.edu/BIT/burrise/pl/requirements/ |title=Requirements Specification |work=CS451R, University of Missouri–Kansas City |author=Burris, E. |publisher=University of Missouri–Kansas City |date=2007 |archivedate=24 July 2019 |accessdate=02 February 2020}}</ref> This latest version is different, focusing strictly on a regulatory-, standards-, and guidance-based approach to building a specification document for laboratory informatics systems.
| |
| | |
| At its core, LIMSpec is rooted in [[ASTM E1578|ASTM E1578-18]] ''Standard Guide for Laboratory Informatics''. With the latest version released in 2018, the standard includes an updated Laboratory Informatics Functional Requirements checklist, which "covers functionality common to the various laboratory informatics systems discussed throughout [the] guide as well as requirements recommended as part of [the] guide." It goes on to state that the checklist "is an example of typical requirements that can be used to guide the purchase, upgrade, or development of a laboratory informatics system," though it is certainly "not meant to be exhaustive."
| |
| | |
| LIMSpec borrows from that requirements checklist and then adds more to it from a wide variety of sources. An attempt has been made to find the most relevant regulations, standards, and guidance that shape how a compliant laboratory informatics system is developed and maintained. However, the LIMSpec should also definitely be considered a continual work in progress, with more to be added as new pertinent regulations, standards, and guidance are discovered.
| |
| | |
| If you've never worked with a user requirements specification document, the concept remains relatively simple to grasp. Merriam-Webster defines a "specification" as "a detailed precise presentation of something or of a plan or proposal for something."<ref name="MWSpec">{{cite web |url=https://www.merriam-webster.com/dictionary/specification |title=specification |work=Merriam-Webster |publisher=Merriam-Webster, Inc |accessdate=02 February 2020}}</ref> Within this organized "plan or proposal" are requirements. A requirement typically comes in the form of a statement that begins with "the system/user/vendor shall/should ..." and focuses on a provided service, reaction to input, or expected behavior in a given situation. The statement may be abstract (high-level), or it may be specific and detailed to a precise function. The statement may also be of a functional nature, describing functionality or services in detail, or of a non-functional nature, describing the constraints of a given functionality or service and how it's rendered.
| |
| | |
| An example of a functional software requirement could be "the user shall be able to query either all of the initial set of databases or select a subset from it." This statement describes specific functionality the system should have. On the other hand, a non-functional requirement, for example, may state "the system's query tool shall conform to the ABC 123-2014 standard." The statement describes a constraint placed upon the system's query functionality. Once compiled, a set of requirements can serve not only to strengthen the software requirements specification, but the requirements set can also be used for bidding on a contract or serve as the basis for a specific contract that is being finalized.<ref name="MemonSoftware10">{{cite web |url=https://www.cs.umd.edu/~atif/Teaching/Spring2010/Slides/3.pdf |format=PDF |title=Software Requirements: Descriptions and specifications of a system |author=Memon, A. |publisher=University of Maryland |date=Spring 2010 |accessdate=02 February 2020}}</ref>
| |
| | |
| The next chapter discusses the user requirements specification, using LIMSpec as an example. You'll learn how to shape such a specification to your laboratory's needs, how to issue the specification as a request for information (RFI), and how to get the most out of it when getting decision-related information from vendors.
| |
| | |
| ==References==
| |
| {{Reflist|colwidth=30em}}
| |
