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<div class="nonumtoc">__TOC__</div>
<div class="nonumtoc">__TOC__</div>
{{ombox
| type      = notice
| style    = width: 960px;
| text      = This is sublevel9 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==
==3. Choosing laboratory informatics software for your food and beverage lab==
Operation of a [[physician office laboratory]] (POL) requires expertise, just like any other laboratory. But how should they be staffed, and what sort of education requirements should the staff have? This chapter addresses those questions and also provides additional resources for staffing a POL.
Computers in the laboratory are not a recent phenomenon. The mid-1960s saw laboratory computerization become increasingly popular<ref name="KriegClinical74">{{cite book |chapter=Chapter 30: Clinical Laboratory Computerization |title=Clinical Diagnosis by Laboratory Methods |author=Krieg, A.F. |editor=Davidsohn, I.; Henry, J.B. |publisher=W.B. Saunders Company |pages=1340–58 |year=1974 |isbn=0721629229}}</ref><ref name="FlynnComputer65">{{cite book |chapter=Computer-assisted processing of bio-chemical test data |title=Progress in Medical Computing |author=Flynn, F.V. |editor=Atkins, H.J.B. |publisher=Blackwell Science Ltd |page=46 |year=1965 |isbn=0632001801}}</ref><ref name="WilliamsTheUse64">{{cite journal |title=The Use of Data Processing and Automation in Clinical Pathology |journal=Military Medicine |author=Williams, G.Z. |volume=129 |issue=6 |pages=502–9 |year=1964 |doi=10.1093/milmed/129.6.502}}</ref><ref name="HicksRoutine66">{{cite journal |title=Routine Use of a Small Digital Computer in the Clinical Laboratory |journal=JAMA |author=Hicks, G.P.; Gieschen, M.M.; Slack, W.V. et al. |volume=196 |issue=11 |pages=973–78 |year=1966 |doi=10.1001/jama.1966.03100240107021}}</ref><ref name="StraumfjordElectronic67">{{cite journal |title=Electronic Data Processing System for Clinical Laboratories: A System Used for All Laboratory Sections |journal=American Journal of Clinical Pathology |author=Straumfjord, J.V.; Spraberry, M.N.; Biggs, H.G.; Noto, T.A. |volume=47 |issue=5_ts |pages=661–76 |year=1967 |doi=10.1093/ajcp/47.5_ts.661}}</ref>, though that enthusiasm was often based on the potential of the computers themselves rather than their actual capabilities.<ref name="KriegClinical74" /> Laboratorians imagined potentials such as automatic sample label generation, daily log and report management, instrument interfacing and data processing, results comparisons, and time management tools. However, it would take time for some of those potentials to be realized.<ref name="KriegClinical74" />


<div align="center">-----Return to [[LII:The Comprehensive Guide to Physician Office Laboratory Setup and Operation|the beginning]] of this guide-----</div>
In 1970, Temple University's Marion Ball, M.A., an assistant professor in the Department of Medical Physics, conducted a survey of pathology directors in clinical laboratories that were using computers. Asking their opinions about the advantages and disadvantages of computerized systems in the lab, she received responses from directors in 15 U.S. states, as well as from three other countries. Responses included<ref name="BallASurvey70">{{cite journal |title=A Survey of Field Experience in Clinical Laboratory Computerization |journal=Laboratory Medicine |author=Ball, M.J. |volume=1 |issue=11 |pages=25–27, 49–51 |year=1970 |doi=10.1093/labmed/1.11.25}}</ref>:
__TOC__
==5. Staffing and Education Requirements==


===General staffing and education===
<blockquote>''The ability to rapidly prepare cumulative records and then to inspect them for possible errors through analysis trends has been proven to be of tremendous advantage in a number of laboratories. We can prevent errors in our analytical systems, but we are not prepared to prevent errors in the collecting of the sample, the mislabeling of the sample, or the accidental use of an incorrect sample. Thus, the ability to inspect data trends presents the only real tool that we currently have to pick out these kinds of errors.'' - Max E. Chilcote, Ph.D, Meyer Memorial Hospital Division</blockquote>
Subpart M of the [[Clinical Laboratory Improvement Amendments]] (CLIA) details requirements and responsibilities for laboratory personnel, consultants, supervisors, and directors.<ref name="CLIARegsM">{{cite web |url=https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-493 |title=Title 42: Public Health, Part 493 — Laboratory Requirements |publisher=U.S. Government Publishing Office |date=13 May 2022 |accessdate=17 May 2022}}</ref> The exception to this is a laboratory with a certificate of waiver, where personnel requirements and proficiency testing is not required. However, manufacturers' instructions must still be carefully followed, and only CLIA-waived tests may be performed by the personnel.


For non-waived laboratories, the following resources provide paraphrasing of [https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-493 CLIA Subpart M]:
<blockquote>''There is little argument about whether an operating computer system can be an advantage in a laboratory, but the most critical time is the installation and transition from a "manual" to a "computer" oriented laboratory.'' - Robert L. Habig, Duke University Medical Center</blockquote>


* [https://www.aafp.org/family-physician/practice-and-career/managing-your-practice/clia/personnel-requirements.html American Academy of Family Physicians - Personnel Requirements]
Reading about these potentials and opinions today, some 50 years later, we see both clear similarities and definite advances. For example, Habig's statement about transitioning from manual to more automated processes still rings true today: it can be nerve wracking and critical to get the transition right. Conversely, while the systems of decades past weren't able to "prevent errors in the collecting of the sample, the mislabeling of the sample, or the accidental use of an incorrect sample," modern [[laboratory informatics]] systems provide many assurances to sample management in the lab. In many cases, activities such as label generation, reporting, results analysis, [[workflow]] control, test ordering, and broad interoperability are commonplace in modern systems.<ref name="JonesInformatics14">{{cite journal |title=Informatics and the Clinical Laboratory |journal=The Clinical Biochemist Reviews |author=Jones, R.G.; Johnson, O.A.; Batstone, G. |volume=35 |issue=3 |pages=177–92 |year=2014 |pmid=25336763 |pmc=PMC4204239}}</ref> And those systems continue to advance, with [[machine learning]] now finding its way into a few laboratory data management and [[Data analysis|analysis]] workflows.<ref name="BurtonNHS18">{{cite web |url=https://towardsdatascience.com/nhs-laboratories-need-data-science-c93f7983302c |title=NHS Laboratories Need Data Science |author=Burton, R. |work=Towards Data Science |date=19 July 2018 |accessdate=07 December 2022}}</ref><ref name="CuffAugment18">{{cite web |url=https://www.nextplatform.com/2018/06/19/augmenting-pathology-labs-with-big-data-and-machine-learning/ |title=Augmenting Pathology Labs with Big Data and Machine Learning |author=Cuff, J. |work=The Next Platform |date=18 June 2018 |accessdate=07 December 2022}}</ref>
* [https://www.aafp.org/family-physician/practice-and-career/managing-your-practice/clia/lab-director-duties.html American Academy of Family Physicians - Physician Office Laboratory (POL) Director Duties]
* [http://www.labflorida.com/internal/COLA/guides/LabGuide4.pdf Commission on Office Laboratory Accreditation (COLA) - Personnel for Non-waived Testing] (PDF)
* [https://www.lighthouselabservices.com/state-license/ Lighthouse Lab Services - Laboratory State License and Personnel & Facility License Info]


In some cases, state governments apply additional regulations and responsibilities to clinical laboratories and their personnel. According to consultancy Lighthouse Lab Services, the following states have staffing, education, and licensing requirements beyond that of CLIA<ref name="LSUCLic">{{cite web |url=https://www.lighthouselabservices.com/state-license/ |title=State-by-State Laboratory Licensing Information |publisher=LMSI, LLC |accessdate=17 May 2022}}</ref>:
We've come a long way since the 1960s, to a point where the question is no longer "can a computerized system help my lab?" but rather "how do I choose and implement an informatics system to help my lab?" What follows is information to help you with that question, while considering the technology, features, security, cost, implementation, and vendor guarantees that come with such a system.


* California: [https://www.cdph.ca.gov/Programs/OSPHLD/LFS/Pages/AboutUs.aspx Department of Public Health - Laboratory Field Services]
* Connecticut: [https://portal.ct.gov/DPH/Communications/Regulation--Licensure/Regulation--Licensure Department of Public Health - Regulation & Licensure]
* Florida: [https://floridasclinicallabs.gov/licensing/ Board of Clinical Laboratory Personnel - Licensing] and [https://ahca.myflorida.com/mchq/health_facility_regulation/Lab_HomeServ/non-waived_apps.shtml Agency for Health Care Administration - Laboratory and In-Home Services Unit]
* Georgia: [https://dch.georgia.gov/divisionsoffices/healthcare-facility-regulation Georgia Department of Community Health - Healthcare Facility Regulation]
* Hawaii: [https://health.hawaii.gov/statelab/ Department of Health - State Laboratories Division]
* Louisiana: [https://www.lsbme.la.gov/licensure/clinical-laboratory-personnel State Board of Medical Examiners - Clinical Laboratory Personnel]
* Montana: [https://boards.bsd.dli.mt.gov/clinical-laboratory-science-practitioners/ Department of Labor and Industry - Montana Board of Clinical Laboratory Science Practitioners]
* Nevada: [https://dpbh.nv.gov/Reg/MedicalLabs/Medical_Laboratories_-_Home/ Nevada Division of Public and Behavioral Health - Medical Laboratory Services]
* New Hampshire: [https://www.dhhs.nh.gov/doing-business-dhhs/licensing-certification/health-facilities-administration Department of Health and Human Services - Health Facilities Administration]
* New Jersey: [https://www.nj.gov/health/phel/ Department of Health - Public Health and Environmental Laboratories]
* New York: [https://www.wadsworth.org/regulatory/clep Department of Health - Clinical Laboratory Evaluation Program] and [http://www.op.nysed.gov/prof/clt/ Education Department - Clinical Laboratory Technology]
* North Dakota: [https://www.ndclinlab.com/ North Dakota Board of Clinical Laboratory Practice]
* Rhode Island: [https://health.ri.gov/licenses/detail.php?id=210 Department of Health - Healthcare Licensing]
* Tennessee: [https://www.tn.gov/health/health-program-areas/health-professional-boards/medlab-board/ml-board/licensure.html Department of Health - Medical Laboratory Board]
* Washington: [https://doh.wa.gov/licenses-permits-and-certificates/facilities-z/laboratory-quality-assurance Department of Health - Laboratory Quality Assurance]
* West Virginia: [https://dhhr.wv.gov/healthprep/programs/laboratory/Pages/default.aspx Department of Health and Human Resources - Office of Laboratory Services]


===List of clinical certification and accreditation opportunities===
===3.1 Evaluation and selection===
* [https://www.aab.org/aab/AAB_Board_of_Registry.asp American Association of Bioanalysts]: The AAB Board of Registry (ABOR) offers five different certifications, including medical technologist (MT) and medical laboratory technician (MLT).
What exactly is a [[laboratory information management system]] (LIMS) anyway? Do I need one? What options are available and how do I compare them? What about a request for information (RFI), request for proposal (RFP), or request for quotation (RFQ)? These are questions [[laboratory]] professionals typically ponder upon finding themselves charged with the mission of finding software for their food and beverage lab. For many the task can be a daunting proposition.
* [https://www.aab.org/aab/Application-Fees.asp American Board of Bioanalysts]: ABB offers several laboratory director certifications.
* [https://www.ashi-hla.org/page/ACHI American College of Histocompatibility and Immunogenetics]: The ACHI provides certifications for histocompatability technologists and directors.
* [https://americanmedtech.org/Certification/Get-Certified American Medical Technologists]: The AMT offers several laboratory-related certifications, including medical technologist (MT) and medical laboratory technician (MLT).
* [https://www.ascp.org/content/board-of-certification/get-credentialed American Society for Clinical Pathology]: The ASCP offers four levels of certification, with numerous subcategories in all but the Diplomate Certification. The four main levels are Technician, Technologist, Specialist, and Diplomate.
* [https://www.ncctinc.com/certifications National Commission of Certifying Agencies]: The NCCT offers several certifications, including medical assistant (NCMA) and phlebotomy technician (NCPT).
* [https://www.nhanow.com/certification National Healthcareer Association]: The NHA offers several certifications, including clinical medical assistant (CCMA) and phlebotomy technician (CPT).
* [https://www.nationalphlebotomy.org/ National Phlebotomy Association]: The NPA offers a certification for phlebotomists.


===Laboratory accreditation programs===
You may know the workflow-related needs of your laboratory, but perhaps you don't know much about [[Information management|data management]] solutions like LIMS, leaving you intimidated by all the options. You'll first need to gauge your lab's informatics needs in order to determine which products are worth investigating further. Of course your lab's analysis requirements, reporting and data sharing constraints, instrument interfacing needs, [[Barcode|barcoding]] and tracking requirements, quality assurance processes, etc. are very important factors. But these systems vary in numerous ways, and other important factors exist. Price should certainly be considered, although value is ultimately more important than a low price. Other important questions that get asked include:
* [https://a2la.org/accreditation/clinical-testing/ A2LA]: "Accredits clinical laboratories to five comprehensive accreditation program"
* [https://www.aabb.org/standards-accreditation/accreditation Association for the Advancement of Blood & Biotherapies]: AABB has an accreditation program for blood and biobanking facilities.
* [https://www.cola.org/ COLA]: Formerly the Commission on Office Laboratory Accreditation; a non-profit accreditor of medical laboratories
* [https://www.cap.org/laboratory-improvement/accreditation/laboratory-accreditation-program College of American Pathologists]: CAP offers a laboratory accreditation program that "accredits laboratories performing testing on specimens from human beings or animals, using methodologies and clinical application within the expertise of the program."
* [https://www.jointcommission.org/accreditation-and-certification/health-care-settings/laboratory-services/ The Joint Commission]: Provides a variety of accreditation and certification programs for healthcare entities, including laboratories
* [http://www.naacls.org/accreditation/ National Accrediting Agency for Clinical Laboratory Sciences]: The NAACLS accredits and approved educational programs in the clinical laboratory sciences.


===List of educational programs===
*Should we purchase software licenses or "rent" the software via a subscription-based model?
====Higher-education====
*Does the software need to be on-site, or is a [[Software as a service|SaaS]] hosted option more practical?
{|
*Is a modular or complete system better for us?
| STYLE="vertical-align:top;"|
*What is the best licensing/rental scheme for us? Should we consider site, named user, concurrent user, or workstation licenses?
{| class="wikitable collapsible sortable" border="1" cellpadding="5" cellspacing="0" width="60%"
*Is the company qualified and trustworthy?
|-
*What functionality is available to help our lab not only accomplish workflow tasks but also remain regulatory compliant?
  ! colspan="4"| Higher-education programs
|-
  ! style="color:brown; background-color:#ffffee;"| School
  ! style="color:brown; background-color:#ffffee;"| Location
  ! style="color:brown; background-color:#ffffee;"| Program
  ! style="color:brown; background-color:#ffffee;"| Description
|-
  | style="font-weight: bold; padding-left:10px;"|Albany College of Pharmacy and Health Sciences
  | style="background-color:white; padding-left:10px;"|U.S. - NY (Albany)
  | style="background-color:white; padding-left:10px;"|[https://www.acphs.edu/clinical-laboratory-sciences Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offerings: B.S. in Clinical Laboratory Sciences
|-
  | style="font-weight: bold; padding-left:10px;"|Allen College
  | style="background-color:white; padding-left:10px;"|U.S. - IA (Waterloo)
  | style="background-color:white; padding-left:10px;"|[https://www.allencollege.edu/medical-laboratory-science-mls.aspx Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"Students receive the Bachelor of Health Sciences degree with a MLS major and qualify for MLS certification upon completion of program requirements. This option is also possible for those who already have an associate's or baccalaureate degree and have completed all general education courses."
|-
  | style="font-weight: bold; padding-left:10px;"|Andrews University
  | style="background-color:white; padding-left:10px;"|U.S. - IL (Chicago)
  | style="background-color:white; padding-left:10px;"|[https://www.andrews.edu/chhs/mls/programs/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offerings: First- and second-degree Bachelor in MLS; certificate in MLS; Affiliate Guest Student Clinical (Senior) Year; Bachelor of Science in Allied Health Administration
|-
  | style="font-weight: bold; padding-left:10px;"|Arizona State University
  | style="background-color:white; padding-left:10px;"|U.S. - AZ (Phoenix)
  | style="background-color:white; padding-left:10px;"|[https://chs.asu.edu/programs/applied-science-medical-laboratory-science Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"The BAS program in applied science with a concentration in medical laboratory sciences provides the academic knowledge and professional skills that enable students to advance their employment opportunities within the fields of medical technology, cytology, clinical laboratory science and related areas."
|- 
  | style="font-weight: bold; padding-left:10px;"|Arkansas State University
  | style="background-color:white; padding-left:10px;"|U.S. - AR (Jonesboro)
  | style="background-color:white; padding-left:10px;"|[https://www.astate.edu/college/conhp/departments/clinical-laboratory-sciences/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers a B.S. and an A.A.S. in Clinical Laboratory Science
|-  
  | style="font-weight: bold; padding-left:10px;"|Armstrong State University
  | style="background-color:white; padding-left:10px;"|U.S. - GA (Savannah)
  | style="background-color:white; padding-left:10px;"|[https://chp.georgiasouthern.edu/diagnostic/programs/medical-laboratory-science/Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Armstrong offers the Bachelor of Science in Medical Laboratory Science in three tracks: Traditional, MLT to MLS Online, and MLS Online Fast Track (for South Carolina residents only).
|-
  | style="font-weight: bold; padding-left:10px;"|Auburn University at Montgomery
  | style="background-color:white; padding-left:10px;"|U.S. - AL (Montgomery)
  | style="background-color:white; padding-left:10px;"|[https://www.aum.edu/nursingandhealth/academic-departments-2/medical-and-clinical-laboratory-sciences/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|The university offers a B.S. in Medical Laboratory Science.
|- 
  | style="font-weight: bold; padding-left:10px;"|Augusta University
  | style="background-color:white; padding-left:10px;"|U.S. - GA (Augusta)
  | style="background-color:white; padding-left:10px;"|[https://www.augusta.edu/academics/clinical-lab-science.php Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offerings: B.S. and M.S. in Clinical Laboratory Sciences (CLS), as well as B.S. in CLS with military specialization
|-
  | style="font-weight: bold; padding-left:10px;"|Augustana College
  | style="background-color:white; padding-left:10px;"|U.S. - SD (Sioux Falls)
  | style="background-color:white; padding-left:10px;"|[https://www.augie.edu/academics/majors-and-programs/medical-laboratory-science-and-health-professional-programs Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|The school offers [http://augie.smartcatalogiq.com/2019-2020/2019-2020-Undergraduate-General-Catalog/Academic-Program/Medical-Laboratory-Science two plans] for earning a B.S. in Medical Laboratory Science.
|-
  | style="font-weight: bold; padding-left:10px;"|Austin Community College District
  | style="background-color:white; padding-left:10px;"|U.S. - TX (Austin)
  | style="background-color:white; padding-left:10px;"|[https://sites.austincc.edu/health/mlab/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers a Medical Laboratory Technology Associate of Applied Science (AAS) degree
|-
  | style="font-weight: bold; padding-left:10px;"|Austin Peay State University
  | style="background-color:white; padding-left:10px;"|U.S. - TN (Clarksville)
  | style="background-color:white; padding-left:10px;"|[https://www.apsu.edu/medical-technology/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|The university offers a B.S. in Medical Laboratory Science.
|- 
  | style="font-weight: bold; padding-left:10px;"|Baptist Health College Little Rock
  | style="background-color:white; padding-left:10px;"|U.S. - AR (Little Rock)
  | style="background-color:white; padding-left:10px;"|[https://www.bhclr.edu/academics/programs/medical-laboratory-science/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|The college offers a B.S. or certificate in Medical Laboratory Science.
|-
  | style="font-weight: bold; padding-left:10px;"|Baptist Health Sciences University
  | style="background-color:white; padding-left:10px;"|U.S. - TN (Memphis)
  | style="background-color:white; padding-left:10px;"|[https://www.baptistu.edu/medical-laboratory-science Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|The university offers a B.S. in Medical Laboratory Science.
|-
  | style="font-weight: bold; padding-left:10px;"|Bellarmine University
  | style="background-color:white; padding-left:10px;"|U.S. - KY (Louisville)
  | style="background-color:white; padding-left:10px;"|[https://www.bellarmine.edu/health-professions/undergraduate/bachelor-of-health-science-in-medical-lab-science/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers three Bachelor of Health Science degree tracks in MLS: 4-Year Practitioner Track, 4-Year Pre-professional Track, and an Accelerated Second Degree
|-
  | style="font-weight: bold; padding-left:10px;"|Bemidji State University
  | style="background-color:white; padding-left:10px;"|U.S. - MN (Bemidji)
  | style="background-color:white; padding-left:10px;"|[https://www.bemidjistate.edu/academics/departments/biology/courses-programs/medical-laboratory-science-b-s/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers two B.S. tracks: 3+1 and 4+1
|-
  | style="font-weight: bold; padding-left:10px;"|Boise State University
  | style="background-color:white; padding-left:10px;"|U.S. - ID (Boise)
  | style="background-color:white; padding-left:10px;"|[https://www.boisestate.edu/preprofessional/pathways/clinical-labs/ Pre-medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"Pre-professional studies is designed for students who need to have undergraduate studies prior to applying to a professional school."
|-
  | style="font-weight: bold; padding-left:10px;"|Bradley University
  | style="background-color:white; padding-left:10px;"|U.S. - IL (Peoria)
  | style="background-color:white; padding-left:10px;"|[https://www.bradley.edu/academic/colleges/las/interprograms/medlab/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|The university offers a B.S. in Medical Laboratory Science.
|-
  | style="font-weight: bold; padding-left:10px;"|Brigham Young University
  | style="background-color:white; padding-left:10px;"|U.S. - UT (Provo)
  | style="background-color:white; padding-left:10px;"|[https://mmbio.byu.edu/medical-laboratory-science Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"Students declare a Pre-MLS Major and are accepted into the program in their Junior year. Once in the program, students have two semesters of intensive coursework after which they intern in a clinical facility for six months."
|-
  | style="font-weight: bold; padding-left:10px;"|British Columbia Institute of Technology
  | style="background-color:white; padding-left:10px;"|Canada - BC (Burnaby)
  | style="background-color:white; padding-left:10px;"|[https://www.bcit.ca/programs/medical-laboratory-science-diploma-full-time-6615dipma/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"Two-and-a-half year, full-time, Diploma program ... Students are ready to write the national certification exam upon graduation."
|- 
  | style="font-weight: bold; padding-left:10px;"|Brookline College
  | style="background-color:white; padding-left:10px;"|U.S. - AZ (Phoenix)
  | style="background-color:white; padding-left:10px;"|[https://www.brooklinecollege.edu/programs/healthcare/bachelors-degree-in-medical-laboratory-science/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"Our program includes a mix of classroom and clinical instruction and a professional seminar to prepare you for entry-level positions in the field. In just 128 weeks, you can earn your bachelor’s degree and be on your way to a successful career as a Medical Laboratory Scientist." The college also offers an [https://www.brooklinecollege.edu/programs/healthcare/associate-degree-medical-laboratory-technician/ A.A.S. degree] in Medical Laboratory Technician.
|-
  | style="font-weight: bold; padding-left:10px;"|Calhoun Community College
  | style="background-color:white; padding-left:10px;"|U.S. - AL (Huntsville)
  | style="background-color:white; padding-left:10px;"|[https://calhoun.edu/health-sciences/medical-laboratory-technician/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers an A.A.S. in Medical Laboratory Technician
|- 
  | style="font-weight: bold; padding-left:10px;"|California State University - Dominguez Hills
  | style="background-color:white; padding-left:10px;"|U.S. - CA (Carson)
  | style="background-color:white; padding-left:10px;"|[https://www.csudh.edu/health-sciences/clinical-science/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|The university offers a B.S. and certificate program in Clinical Science - Medical Technology.
|- 
  | style="font-weight: bold; padding-left:10px;"|California State University - LA
  | style="background-color:white; padding-left:10px;"|U.S. - CA (Los Angeles)
  | style="background-color:white; padding-left:10px;"|[https://www.calstatela.edu/page/clinical-laboratory-scientist-certificate Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|The university offers a post-baccalaureate certificate program in Clinical Laboratory Scientist.
|-
  | style="font-weight: bold; padding-left:10px;"|Cambrian College
  | style="background-color:white; padding-left:10px;"|Canada - ON (Sudbury)
  | style="background-color:white; padding-left:10px;"|[https://cambriancollege.ca/programs/medical-laboratory-technology/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Six-semester program; "Graduates are eligible to write the national certification examinations conducted by the Canadian Society for Medical Laboratory Sciences (CSMLS)."
|-
  | style="font-weight: bold; padding-left:10px;"|Canisius College
  | style="background-color:white; padding-left:10px;"|U.S. - NY (Buffalo)
  | style="background-color:white; padding-left:10px;"|[https://www.canisius.edu/academics/programs/undergraduate/clinical-laboratory-science Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"...three years of campus-based classroom and lab work, one year of a hands-on internship in an accredited hospital laboratory."
|-
  | style="font-weight: bold; padding-left:10px;"|Carolinas College of Health Sciences
  | style="background-color:white; padding-left:10px;"|U.S. - NC (Charlotte)
  | style="background-color:white; padding-left:10px;"|[https://atriumhealth.org/education/carolinas-college-of-health-sciences/academic-programs/medical-laboratory-science Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"The Medical Laboratory Science program is a 12-month program that prepares graduates to be a successful entry-level medical laboratory scientist. Didactic lectures and student laboratory training take place at the college, with clinical experiences conducted in the laboratories of Atrium Health."
|-
  | style="font-weight: bold; padding-left:10px;"|Centennial College
  | style="background-color:white; padding-left:10px;"|Canada - ON (Scarborough)
  | style="background-color:white; padding-left:10px;"|[https://www.centennialcollege.ca/programs-courses/full-time/medical-laboratory-technician/ Medical Laboratory Technician Program]
  | style="background-color:white; padding-left:10px;"|"Credential: Ontatio College Certificate; Program Type: Post-secondary program; Program Length: 1 year/ 3 semesters"
|- 
  | style="font-weight: bold; padding-left:10px;"|Central Arizona College
  | style="background-color:white; padding-left:10px;"|U.S. - AZ (Coolidge)
  | style="background-color:white; padding-left:10px;"|[https://centralaz.edu/divisions-programs/nursing-health-emergency-careers/medical-laboratory-technician-aas/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers an A.A.S. in Medical Laboratory Technician
|-
  | style="font-weight: bold; padding-left:10px;"|Central New Mexico Community College
  | style="background-color:white; padding-left:10px;"|U.S. - NM (Albuquerque)
  | style="background-color:white; padding-left:10px;"|[https://www.cnm.edu/programs-of-study/programs-a-z/medical-laboratory-sciences Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offerings: Medical Laboratory Technician, Associate of Applied Science; Phlebotomy Technician, Certificate of Achievement
|-
  | style="font-weight: bold; padding-left:10px;"|Central of Southern Nevada
  | style="background-color:white; padding-left:10px;"|U.S. - NV (Las Vegas)
  | style="background-color:white; padding-left:10px;"|[https://www.csn.edu/archived/programs/medical-laboratory Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offerings: AAS in Medical Laboratory Technician, BAS in Medical Laboratory Science, Certificate in Phlebotomy
|-
  | style="font-weight: bold; padding-left:10px;"|College of the Canyons
  | style="background-color:white; padding-left:10px;"|U.S. - CA (Santa Clarita)
  | style="background-color:white; padding-left:10px;"|[https://www.canyons.edu/academics/mlt/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|The university offers an A.A.S. in Medical Laboratory Technician
|-
  | style="font-weight: bold; padding-left:10px;"|College of the North Atlantic
  | style="background-color:white; padding-left:10px;"|Canada - NL (St. John's)
  | style="background-color:white; padding-left:10px;"|[https://www.cna.nl.ca/program/medical-laboratory-technology Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"The curriculum for this program is designed to encompass three years of training ... Graduates of the program at the Prince Philip Drive Campus will be eligible to sit the certification examination set by the Canadian Society for Medical Laboratory Science (CSMLS)."
|-
  | style="font-weight: bold; padding-left:10px;"|Dalhousie University
  | style="background-color:white; padding-left:10px;"|Canada - NS (Halifax)
  | style="background-color:white; padding-left:10px;"|[https://www.dal.ca/faculty/health/health-sciences/programs/post-diploma-bhsc-program/medical-laboratory-technology.html Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"The post-diploma BHSc curriculum in Medical Laboratory Technololgy is equivalent to 2 years of full time university study (a total of 60 credit hours or 20 courses)."
|- 
  | style="font-weight: bold; padding-left:10px;"|DeAnza College
  | style="background-color:white; padding-left:10px;"|U.S. - CA (Cupertino)
  | style="background-color:white; padding-left:10px;"|[https://www.deanza.edu/mlt/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|The university offers an A.A.S. and certificate program in Medical Laboratory Technology.
|-
  | style="font-weight: bold; padding-left:10px;"|East Carolina University
  | style="background-color:white; padding-left:10px;"|U.S. - NC (Greenville)
  | style="background-color:white; padding-left:10px;"|[https://clinicallaboratoryscience.ecu.edu/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers a B.S. in Clinical Laboratory Science (CLS). A dual-degree program in CLS and biology also available.
|-
  | style="font-weight: bold; padding-left:10px;"|Eastern Kentucky University
  | style="background-color:white; padding-left:10px;"|U.S. - KY (Richmond)
  | style="background-color:white; padding-left:10px;"|[https://mls.eku.edu/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"Our department offers an accredited program leading to a Bachelor of Science degree (BS) in Medical laboratory Science."
|-
  | style="font-weight: bold; padding-left:10px;"|Eastern Michigan University
  | style="background-color:white; padding-left:10px;"|U.S. - MI (Ypsilanti)
  | style="background-color:white; padding-left:10px;"|[https://www.emich.edu/chhs/health-sciences/programs/clinical-lab-sciences/index.php Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"The CLS program at EMU offers four concentrations, each leading to a bachelor's degree. Three of the four concentrations require a six- to 12-month clinical practicum in an affiliated hospital during the senior year."
|-
  | style="font-weight: bold; padding-left:10px;"|Emory Healthcare
  | style="background-color:white; padding-left:10px;"|U.S. - GA (Atlanta)
  | style="background-color:white; padding-left:10px;"|[https://www.emoryhealthcare.org/careers/medical-technology.html Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"The program is designed to prepare students (already holding a bachelor's degree) for the national Medical Laboratory Science certifying examination by the American Society for Clinical Pathology (ASCP). Students are awarded a certificate in Medical Laboratory Science from the EHC MLS upon successful completion of the program."
|-
  | style="font-weight: bold; padding-left:10px;"|Ferris State University
  | style="background-color:white; padding-left:10px;"|U.S. - MI (Big Rapids)
  | style="background-color:white; padding-left:10px;"|[https://www.ferris.edu/health-professions/DLTS/Bachelors/Medical-Laboratory-Science/index.htm Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers a B.S. in Medical Laboratory Science
|-
  | style="font-weight: bold; padding-left:10px;"|Florida Gulf Coast University
  | style="background-color:white; padding-left:10px;"|U.S. - FL (Fort Myers)
  | style="background-color:white; padding-left:10px;"|[https://www.fgcu.edu/mariebcollege/healthsciences/clinicallaboratoryscience-bs Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers both a B.S. in Clinical Laboratory Science (CLS) and a certificate in CLS
|-
  | style="font-weight: bold; padding-left:10px;"|Fortis Institute - Birmingham
  | style="background-color:white; padding-left:10px;"|U.S. - AL (Birmingham)
  | style="background-color:white; padding-left:10px;"|[https://www.fortis.edu/campuses/alabama/birmingham/medical-laboratory-technician.html Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers an A.A.S. in Medical Laboratory Technology
|-
  | style="font-weight: bold; padding-left:10px;"|Gadsen State Community College
  | style="background-color:white; padding-left:10px;"|U.S. - AL (Gadsden)
  | style="background-color:white; padding-left:10px;"|[https://www.gadsdenstate.edu/programs-of-study/med-lab-tech.cms Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers an A.A.S. in Medical Laboratory Technology
|-
  | style="font-weight: bold; padding-left:10px;"|George Mason University
  | style="background-color:white; padding-left:10px;"|U.S. - VA (Fairfax)
  | style="background-color:white; padding-left:10px;"|[https://science.gmu.edu/academics/departments-units/biology/medical-laboratory-science-bs Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers a B.S. in Medical Laboratory Science, with concentrations in Molecular Biology or Microbiology
|-
  | style="font-weight: bold; padding-left:10px;"|George Washington University
  | style="background-color:white; padding-left:10px;"|U.S. - DC (Washington)
  | style="background-color:white; padding-left:10px;"|[https://mls.smhs.gwu.edu/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers a wide variety of bachelor's, post-bachelor's, and master's programs in Medical Laboratory Science
|-
  | style="font-weight: bold; padding-left:10px;"|Grand Valley State University
  | style="background-color:white; padding-left:10px;"|U.S. - MI (Allendale)
  | style="background-color:white; padding-left:10px;"|[https://www.gvsu.edu/acad-view.htm?pdfId=044BA7A3-0FD9-1768-4300A4019A95BB48 Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"Graduates receive a Bachelor of Science (B.S.) degree in MLS. Students spend five semesters completing their general education and core science courses, followed by three semesters of MLS professional courses ... After admission to the program, students complete professional coursework, which also includes 18 weeks of clinical rotations at an affiliated hospital laboratory. MLS is a secondary admission program."
|-
  | style="font-weight: bold; padding-left:10px;"|Heritage University
  | style="background-color:white; padding-left:10px;"|U.S. - WA (Toppenish)
  | style="background-color:white; padding-left:10px;"|[https://www.heritage.edu/academic-paths/undergraduate-degrees/medical-laboratory-science-program/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers a B.S. and certificate in Medical Laboratory Science
|-
  | style="font-weight: bold; padding-left:10px;"|Houston Methodist
  | style="background-color:white; padding-left:10px;"|U.S. - TX (Houston)
  | style="background-color:white; padding-left:10px;"|[https://www.houstonmethodist.org/education/allied-health/medical-laboratory-science-education-program/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"Houston Methodist Hospital Medical Laboratory Science Program is a 12-month professional course of study, which is fully accredited by the National Accrediting Agency for Clinical Laboratory Sciences (NAACLS). Upon successful completion of this course of study, you will qualify for the examination and certification by the board of certification of the American Society of Clinical Pathology (ASCP)."
|-
  | style="font-weight: bold; padding-left:10px;"|Howard University
  | style="background-color:white; padding-left:10px;"|U.S. - DC (Washington)
  | style="background-color:white; padding-left:10px;"|[https://cnahs.howard.edu/departments/clinical-laboratory-sciences Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"Our four-year curriculum for the bachelor’s degree is divided into two sections: the Lower Division and Upper Division."
|-
  | style="font-weight: bold; padding-left:10px;"|Hunter College
  | style="background-color:white; padding-left:10px;"|U.S. - NY (New York)
  | style="background-color:white; padding-left:10px;"|[https://hunter-undergraduate.catalog.cuny.edu/departments/MLS-HTR/overview Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"Two academic degrees for undergraduates are offered: the BS in Medical Laboratory Sciences: Biomedical Science and the BS in Medical Laboratory Sciences: Clinical Science. Both majors emphasize laboratory training through classroom work."
|-
  | style="font-weight: bold; padding-left:10px;"|Idaho State University
  | style="background-color:white; padding-left:10px;"|U.S. - ID (Pocatello)
  | style="background-color:white; padding-left:10px;"|[https://www.isu.edu/mls/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|The university offers a B.S. in Medical Laboratory Science
|-
  | style="font-weight: bold; padding-left:10px;"|Illinois State University
  | style="background-color:white; padding-left:10px;"|U.S. - IL (Normal)
  | style="background-color:white; padding-left:10px;"|[https://healthsciences.illinoisstate.edu/medical-laboratory-science/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|The university offers a B.S. in Medical Laboratory Science
|- 
  | style="font-weight: bold; padding-left:10px;"|Immaculata University
  | style="background-color:white; padding-left:10px;"|U.S. - PA (Immaculata)
  | style="background-color:white; padding-left:10px;"|[https://www.immaculata.edu/academics/degrees-programs/allied-health-b-s-undergraduate-studies/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|The university offers a B.S. in Allied Health, with a concentration in Medical Laboratory Science
|- 
  | style="font-weight: bold; padding-left:10px;"|Indiana State University
  | style="background-color:white; padding-left:10px;"|U.S. - IN (Terre Haute)
  | style="background-color:white; padding-left:10px;"|[https://catalog.indstate.edu/preview_program.php?catoid=24&poid=4137&returnto=619 Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"Biology with Specialization in Medical Laboratory Science Major (3-plus-1 Program) ... Fourth-year students accepted to the clinical courses register as full-time ISU students and, upon successful completion of the 12-month program, receive the 32-34 credit hours that are required for completion of the bachelor of science degree."
|-
  | style="font-weight: bold; padding-left:10px;"|Jefferson State Community College
  | style="background-color:white; padding-left:10px;"|U.S. - AL (Birmingham)
  | style="background-color:white; padding-left:10px;"|[https://www.jeffersonstate.edu/programs/medical-laboratory-technology/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers an A.A.S. in Medical Laboratory Technology
|-
  | style="font-weight: bold; padding-left:10px;"|Lake Area Technical College
  | style="background-color:white; padding-left:10px;"|U.S. - SD (Watertown)
  | style="background-color:white; padding-left:10px;"|[https://www.lakeareatech.edu/academics/on-campus-programs/medical-laboratory-technician/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|The technical college offers an A.A.S. in Medical Laboratory Technician.
|-
  | style="font-weight: bold; padding-left:10px;"|Lincoln Memorial University
  | style="background-color:white; padding-left:10px;"|U.S. - TN (Harrogate)
  | style="background-color:white; padding-left:10px;"|[https://www.lmunet.edu/school-of-medical-sciences/mls/index Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|The university offers a B.S. in Medical Laboratory Science
|-
  | style="font-weight: bold; padding-left:10px;"|Loma Linda University
  | style="background-color:white; padding-left:10px;"|U.S. - CA (Loma Linda)
  | style="background-color:white; padding-left:10px;"|[https://alliedhealth.llu.edu/academics/clinical-laboratory-science-cls Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|The university offers a B.S. in Clinical Laboratory Science, as well as a Phlebotomy certificate
|-
  | style="font-weight: bold; padding-left:10px;"|Long Island University
  | style="background-color:white; padding-left:10px;"|U.S. - NY (Brookville)
  | style="background-color:white; padding-left:10px;"|[https://www.liu.edu/CWPost/Academics/Schools/SHPN/Dept/Biomedical/Undergraduate-Programs/BS-BS-CLS Medical Laboratory Science Program - B.S.]<br />[https://www.liu.edu/CWPost/Academics/Schools/SHPN/Dept/Biomedical/Graduate-Programs/MS-CLS Medical Laboratory Science Program - M.S.]
  | style="background-color:white; padding-left:10px;"|Offerings: B.S. and M.S.
|-
  | style="font-weight: bold; padding-left:10px;"|Louisiana State University of Alexandria
  | style="background-color:white; padding-left:10px;"|U.S. - LA (Alexandria)
  | style="background-color:white; padding-left:10px;"|[https://www.lsua.edu/academics/colleges/college-of-health-human-services/allied-health/degree-programs Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offerings: B.S. (3+1), B.S. (MLT-LMS), and Associate's in Medical Laboratory Science
|-
  | style="font-weight: bold; padding-left:10px;"|Marquette University
  | style="background-color:white; padding-left:10px;"|U.S. - WI (Milwaukee)
  | style="background-color:white; padding-left:10px;"|[https://www.marquette.edu/medical-laboratory-science/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|The university offers a B.S. in Medical Laboratory Science
|-
  | style="font-weight: bold; padding-left:10px;"|Marshall University
  | style="background-color:white; padding-left:10px;"|U.S. - WV (Huntington)
  | style="background-color:white; padding-left:10px;"|[https://www.marshall.edu/clinical-laboratory-science/programs/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Options: Associate of Applied Science in Medical Laboratory Science (AAS-MLT) and Online Bachelor of Science in Medical Laboratory Science (BS MLS)
|-
  | style="font-weight: bold; padding-left:10px;"|Marywood University
  | style="background-color:white; padding-left:10px;"|U.S. - PA (Scranton)
  | style="background-color:white; padding-left:10px;"|[https://www.marywood.edu/science/majors/medical-laboratory-science/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"Students may spend three years at Marywood University fulfilling the university requirements and those of the National Accrediting Agency for Clinical Laboratory Science (NAACLS). In this program, the students spend the fourth year at an accredited school of MLS, gaining theoretical and practical experience in the field of MLS."
|-
  | style="font-weight: bold; padding-left:10px;"|Mayo School of Health Sciences
  | style="background-color:white; padding-left:10px;"|U.S. - MN (Rochester) and FL (Jacksonville)
  | style="background-color:white; padding-left:10px;"|[https://college.mayo.edu/academics/health-sciences-education/medical-laboratory-science-program-florida-and-minnesota/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"The Medical Laboratory Science program at Mayo Clinic offers a 10.5 month training program, consisting of classroom lectures and hands-on clinical rotations. The entire program earns the student 35 academic credit hours ... Upon successful completion of this program, you receive a certificate of completion from Mayo Clinic School of Health Sciences. Students enrolled in the 3+1 program receive a certificate in medical laboratory science from the Mayo Clinic School of Health Sciences and a baccalaureate degree from their home institution. Students enrolling in the 4+1 post-baccalaureate program receive a certificate in medical laboratory science from the Mayo Clinic School of Health Sciences."
|-
  | style="font-weight: bold; padding-left:10px;"|McNeese State University
  | style="background-color:white; padding-left:10px;"|U.S. - LA (Lake Charles)
  | style="background-color:white; padding-left:10px;"|[https://catalog.mcneese.edu/preview_program.php?catoid=11&poid=1613&returnto=442 Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"The curriculum consists of 120 semester hours. The first three years (81 hours) are completed on campus while the final year or clinical internship (39 hours) requires students to participate in web-based courses, campus lectures, and medical laboratory instruction."
|-
  | style="font-weight: bold; padding-left:10px;"|Mercy College of Health Sciences
  | style="background-color:white; padding-left:10px;"|U.S. - IA (Des Moines)
  | style="background-color:white; padding-left:10px;"|[https://www.mchs.edu/Academics/Certificate-Programs/Medical-Laboratory-Science Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"Our three-semester Medical Laboratory Science (MLS) certificate offers one start date per year in the fall and includes intensive classroom instruction and clinical laboratory experiences."
|-
  | style="font-weight: bold; padding-left:10px;"|Metropolitan State University of Denver
  | style="background-color:white; padding-left:10px;"|U.S. - CO (Denver)
  | style="background-color:white; padding-left:10px;"|[https://www.msudenver.edu/medical-laboratory-science/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"The Colorado Center for Medical Laboratory Science, a program of Metropolitan State University of Denver, offers post BS-level professional education in Medical Laboratory Science."
|-
  | style="font-weight: bold; padding-left:10px;"|Miami Dade College
  | style="background-color:white; padding-left:10px;"|U.S. - FL (Miami)
  | style="background-color:white; padding-left:10px;"|[https://www.mdc.edu/medicaltechnology/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"This two-year Associate in Science degree program prepares students to work as part of the health care delivery team in a hospital, private clinical laboratory, or research laboratory ... The program requires a total of 76 credits, including general education requirement courses. This program offers a day track and evening track."
|-
  | style="font-weight: bold; padding-left:10px;"|Miami University
  | style="background-color:white; padding-left:10px;"|U.S. - OH (Oxford)
  | style="background-color:white; padding-left:10px;"|[https://programs.miamioh.edu/program/medical-laboratory-science-bs/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|The university offers a B.S. in Medical Laboratory Science
|-
  | style="font-weight: bold; padding-left:10px;"|Michener Institute
  | style="background-color:white; padding-left:10px;"|Canada - ON (Toronto)
  | style="background-color:white; padding-left:10px;"|[https://michener.ca/program/medical-laboratory-science/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Michener offers an advanced diploma (seven semesters across three years) in Medical Laboratory Science
|-
  | style="font-weight: bold; padding-left:10px;"|Michigan State University
  | style="background-color:white; padding-left:10px;"|U.S. - MI (East Lansing)
  | style="background-color:white; padding-left:10px;"|[https://bld.natsci.msu.edu/academics/undergraduate-programs/medical-laboratory-sciences/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"The medical laboratory science (MLS) major does that with 14 credits of courses earned in residence at affiliated laboratories in Michigan and Ohio – total credits = 134."
|-
  | style="font-weight: bold; padding-left:10px;"|Michigan Technological University
  | style="background-color:white; padding-left:10px;"|U.S. - MI (Houghton)
  | style="background-color:white; padding-left:10px;"|[https://www.mtu.edu/biological/undergraduate/medical/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"The Medical Laboratory Science program is all about options - and with two degree concentrations, students can choose the route that best suits them. "
|-
  | style="font-weight: bold; padding-left:10px;"|Minnesota State Community and Technical College
  | style="background-color:white; padding-left:10px;"|U.S. - MN (Ferguson Falls)
  | style="background-color:white; padding-left:10px;"|[https://www.minnesota.edu/programs-and-degrees/medical-laboratory-technology#Medical_Laboratory_Technology Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"M State's 60-credit Associate in Science degree in Medical Laboratory Technology prepares students for lab technician positions ... The two-year program  includes three semesters of general education, science and MLT courses, followed by 16 weeks of clinical experience in an affiliate hospital laboratory."
|- 
  | style="font-weight: bold; padding-left:10px;"|Minnesota State University - Mankato
  | style="background-color:white; padding-left:10px;"|U.S. - MN (Mankato)
  | style="background-color:white; padding-left:10px;"|[https://www.mnsu.edu/academics/academic-catalog/undergraduate/medical-laboratory-science/medical-laboratory-science-bs/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers a B.S. in Medical Laboratory Science
|-
  | style="font-weight: bold; padding-left:10px;"|Minot State University
  | style="background-color:white; padding-left:10px;"|U.S. - ND (Minot)
  | style="background-color:white; padding-left:10px;"|[https://www.minotstateu.edu/enroll/programs/medical-lab-science.shtml Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"The medical laboratory science (MLS) program at Minot State University consists of courses designed to give you the necessary scientific background to enter clinical training at an accredited hospital laboratory. Three years of academic coursework will be completed at Minot State. Then, through an affiliation with the University of North Dakota (UND), you will spend 12 months in a clinical internship at one of the many participating accredited hospitals as a member of the Western College Alliance for MLS. Successful completion of the program results in a BS degree, and upon passing board exams, the title medical laboratory technologist."
|-
  | style="font-weight: bold; padding-left:10px;"|Monmouth University (and Rutgers)
  | style="background-color:white; padding-left:10px;"|U.S. - NJ (West Long Branch/Newark)
  | style="background-color:white; padding-left:10px;"|[https://www.monmouth.edu/department-of-chemistry/medical-laboratory-science/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"Students majoring in Medical Laboratory Science complete 96 credits of collegiate work at Monmouth University, prescribed by the National Accrediting Agency for Clinical Laboratory Sciences (NAACLS), followed by a twelve-month internship in an affiliated NAACLS-approved hospital."
|-
  | style="font-weight: bold; padding-left:10px;"|Montana State University
  | style="background-color:white; padding-left:10px;"|U.S. - MT (Bozeman)
  | style="background-color:white; padding-left:10px;"|[http://www.montana.edu/mbi/mmlstp/AbouttheProgram.html Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"Students train during the summer at MSU and then move to one of eight hospitals for two semesters of clinical laboratory rotations. The program requires tuition and lab fees and students receive 37 credits over three semesters." 3+1 and 4+1 plans available.
|-
  | style="font-weight: bold; padding-left:10px;"|Mount Mercy University
  | style="background-color:white; padding-left:10px;"|U.S. - IA (Cedar Rapids)
  | style="background-color:white; padding-left:10px;"|[https://www.mtmercy.edu/academics/programs/medical-laboratory-science Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"Through our unique and challenging 3+1 program, you’ll graduate with a full year of professional lab experience through an affiliated hospital, allowing you to complete your studies in four years rather than the typical five."
|- 
  | style="font-weight: bold; padding-left:10px;"|National Park College
  | style="background-color:white; padding-left:10px;"|U.S. - AR (Hot Springs)
  | style="background-color:white; padding-left:10px;"|[https://np.edu/academics/health-sciences/medical-lab-technology/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers an A.A.S. in Medical Laboratory Technology
|- 
  | style="font-weight: bold; padding-left:10px;"|North Arkansas College
  | style="background-color:white; padding-left:10px;"|U.S. - AR (Harrison)
  | style="background-color:white; padding-left:10px;"|[http://www.northark.edu/academics/areas-of-study/health-and-medical/aasmedicallaboratorytechnology Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers an A.A.S. in Medical Laboratory Technology
|-
  | style="font-weight: bold; padding-left:10px;"|North Dakota State University
  | style="background-color:white; padding-left:10px;"|U.S. - ND (Fargo)
  | style="background-color:white; padding-left:10px;"|[https://www.ndsu.edu/alliedsciences/programs/mls/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"Your path to a bachelor's of science degree with a major in Medical Laboratory Science (MLS) includes three years of academic coursework, and an 11- to 12-month professional class and clinical experience/ internship within one of NDSU's affiliated hospital programs. All affiliated programs are accredited by the National Accrediting Agency for Clinical Laboratory Science (NAACLS). "
|-
  | style="font-weight: bold; padding-left:10px;"|Northeastern State University
  | style="background-color:white; padding-left:10px;"|U.S. - OK (''Various'')
  | style="background-color:white; padding-left:10px;"|[https://catalog.nsuok.edu/preview_program.php?catoid=15&poid=1369&returnto=449 Medical Laboratory Technician Program 1]<br />[https://catalog.nsuok.edu/preview_program.php?catoid=15&poid=1370&returnto=449 Medical Laboratory Technician Program 2]
  | style="background-color:white; padding-left:10px;"|Offerings: 2+2 and 3+1 B.S.
|-
  | style="font-weight: bold; padding-left:10px;"|Northern College
  | style="background-color:white; padding-left:10px;"|Canada - ON (South Porcupine)
  | style="background-color:white; padding-left:10px;"|[https://www.northernc.on.ca/medical-laboratory-technician/ Medical Laboratory Technician Program]
  | style="background-color:white; padding-left:10px;"|"Credential Earned: Ontario College Certificate; Program Length: 3 Semesters"
|-
  | style="font-weight: bold; padding-left:10px;"|Northern Illinois University
  | style="background-color:white; padding-left:10px;"|U.S. - IL (DeKalb)
  | style="background-color:white; padding-left:10px;"|[https://www.chhs.niu.edu/health-studies/programs/mls/index.shtml Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers traditional B.S. in MLS as well as a degree completion program
|-
  | style="font-weight: bold; padding-left:10px;"|Northwestern College
  | style="background-color:white; padding-left:10px;"|U.S. - IA (Orange City)
  | style="background-color:white; padding-left:10px;"|[http://catalog.nwciowa.edu/preview_program.php?catoid=8&poid=1150&returnto=224 Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"The program is based upon three years of college preparatory work and one year in clinical, professional training at one of several hospital-based programs affiliated with Northwestern College. Upon satisfactory completion of the four years of study, the student will receive the Bachelor of Arts degree with a major in medical laboratory science."
|-
  | style="font-weight: bold; padding-left:10px;"|Ohio Northern University
  | style="background-color:white; padding-left:10px;"|U.S. - OH (Ada)
  | style="background-color:white; padding-left:10px;"|[https://www.onu.edu/academics/medical-laboratory-sciences Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"We offer a NAACLS accredited bachelor’s degree program and a post-baccalaureate certificate program in medical laboratory science. Both programs include biology, chemistry, organic chemistry and anatomy courses and emphasize hands-on learning."
|-
  | style="font-weight: bold; padding-left:10px;"|Ohio State University
  | style="background-color:white; padding-left:10px;"|U.S. - OH (Columbus)
  | style="background-color:white; padding-left:10px;"|[https://hrs.osu.edu/academics/undergraduate-programs/medical-laboratory-science Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers several certification and post-graduate options in Medical Laboratory Science
|-
  | style="font-weight: bold; padding-left:10px;"|Oklahoma Christian University
  | style="background-color:white; padding-left:10px;"|U.S. - OK (Edmond)
  | style="background-color:white; padding-left:10px;"|[https://www.oc.edu/academics/undergraduate-programs/medical-laboratory-science/b-s-degree-in-medical-laboratory-science Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Bachelor's program; "The major consists of three years of university work, plus two semesters of Medical Laboratory Science Program courses."
|-
  | style="font-weight: bold; padding-left:10px;"|Oregon Tech
  | style="background-color:white; padding-left:10px;"|U.S. - OR (Wilsonville)
  | style="background-color:white; padding-left:10px;"|[https://www.oit.edu/academics/degrees/medical-laboratory-science Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"The Bachelor of Science in Medical Laboratory Science (BS MLS) is offered through a joint partnership between Oregon Tech and Oregon Health and Science University (OHSU) ... To make sure our graduates are adept and self-assured professionals, BS MLS students participate in an extensive externship program. This clinical experience, includes an on campus simulated lab completed before students participate in 12 weeks of applied study and training in clinical laboratories."
|-
  | style="font-weight: bold; padding-left:10px;"|Pennsylvania College of Health Sciences
  | style="background-color:white; padding-left:10px;"|U.S. - PN (Lancaster)
  | style="background-color:white; padding-left:10px;"|[https://www.pacollege.edu/academics/health-sciences-certificate-programs/medical-laboratory-scientist-certificate/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers a certificate in Medical Laboratory Science
|- 
  | style="font-weight: bold; padding-left:10px;"|Phillips Community College
  | style="background-color:white; padding-left:10px;"|U.S. - AR (Helena)
  | style="background-color:white; padding-left:10px;"|[https://www.pccua.edu/academics/divisions/allied-health/medical-lab-technology-program/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers an A.A.S. in Medical Laboratory Technology
|-
  | style="font-weight: bold; padding-left:10px;"|Phoenix College
  | style="background-color:white; padding-left:10px;"|U.S. - AZ (Phoenix)
  | style="background-color:white; padding-left:10px;"|[https://www.phoenixcollege.edu/degrees-certificates/medical-laboratory-science Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers an AAS and certificate in Medical Laboratory Science
|-
  | style="font-weight: bold; padding-left:10px;"|Pima Community College
  | style="background-color:white; padding-left:10px;"|U.S. - AZ (Tuscon)
  | style="background-color:white; padding-left:10px;"|[https://www.pima.edu/academics-programs/degrees-certificates/health-sciences/medical-laboratory-technology/medical-lab-tech-aas/index.html Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers an A.A.S. in Medical Laboratory Technician
|-
  | style="font-weight: bold; padding-left:10px;"|Providence Sacred Heart School of Medical Technology
  | style="background-color:white; padding-left:10px;"|U.S. - WA (Spokane)
  | style="background-color:white; padding-left:10px;"|[https://gme.providence.org/washington/dental-pastoral-and-laboratory-programs/laboratory-medicine-education-programs/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers a certificate program that serves as the "+1" of a 3+1 or 4+1 B.S. program
|-
  | style="font-weight: bold; padding-left:10px;"|Purdue University
  | style="background-color:white; padding-left:10px;"|U.S. - IN (West Lafayette)
  | style="background-color:white; padding-left:10px;"|[https://www.purdue.edu/hhs/hsci/students/undergraduate/majors/mlab.html Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"3 years plus 1 year clinical (application required for clinical)"
|-
  | style="font-weight: bold; padding-left:10px;"|Quinnipiac University
  | style="background-color:white; padding-left:10px;"|U.S. - CT (New Haven)
  | style="background-color:white; padding-left:10px;"|[https://www.qu.edu/schools/health-sciences/programs/masters-degree/biomedical-sciences/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"The comprehensive examination in medical laboratory sciences (2 credits) is a requirement for the non-thesis option in the Biomedical Sciences program."
|- 
  | style="font-weight: bold; padding-left:10px;"|Radford University Carilion
  | style="background-color:white; padding-left:10px;"|U.S. - VA (Roanoke)
  | style="background-color:white; padding-left:10px;"|[https://www.radford.edu/content/csat/home/med-lab-science.html Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|B.S. program: "This four-year degree program leads to a Bachelor of Science in Medical Laboratory Science and prepares students for the national certification exam administered by the American Society of Clinical Pathology (ASCP)." The university also has a [https://www.radford.edu/content/ruc/home/mls-certificate.html certificate program]: "This one-year program is designed for applicants who have previously completed a baccalaureate degree in a related science and want to further their education or change careers, but do not have enough transfer credits to complete a second baccalaureate degree in Medical Laboratory Science."
|-
  | style="font-weight: bold; padding-left:10px;"|Red River College
  | style="background-color:white; padding-left:10px;"|Canada - MB (Winnipeg)
  | style="background-color:white; padding-left:10px;"|[https://catalogue.rrc.ca/Programs/WPG/FullTime/MELAF-AD Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers a twenty-eight (28) month advanced diploma in Medical Laboratory Science
|-
  | style="font-weight: bold; padding-left:10px;"|Rush University
  | style="background-color:white; padding-left:10px;"|U.S. - IL (Chicago)
  | style="background-color:white; padding-left:10px;"|[https://www.rushu.rush.edu/college-health-sciences/academic-programs/master-science-medical-laboratory-science Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offerings: M.S.
|-
  | style="font-weight: bold; padding-left:10px;"|Rutgers
  | style="background-color:white; padding-left:10px;"|U.S. - NJ (Newark)
  | style="background-color:white; padding-left:10px;"|[https://shp.rutgers.edu/clinical-lab-and-imaging-sciences/bachelor-of-science-medical-laboratory-sciences/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"Our 45-credit curriculum begins in the summer semester. It can be taken full-time in four semesters, or part-time in eight semesters. It is located on the Newark campus, with some didactic components offered online. On and off-campus practical experiences complement classroom instruction."
|-
  | style="font-weight: bold; padding-left:10px;"|Saginaw Valley State University
  | style="background-color:white; padding-left:10px;"|U.S. - MI (University City)
  | style="background-color:white; padding-left:10px;"|[https://www.svsu.edu/medicallaboratoryscience/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"The program consists of two and one half years of general education and medical laboratory science program prerequisites, including supporting courses in biology and chemistry. The last semester of the third year and the entire fourth year of study consist of the professional phase courses of the program."
|-
  | style="font-weight: bold; padding-left:10px;"|SAIT Polytechnic
  | style="background-color:white; padding-left:10px;"|Canada - AB (Calgary)
  | style="background-color:white; padding-left:10px;"|[https://www.sait.ca/programs-and-courses/diplomas/medical-laboratory-technology Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Two-year diploma including clinical practica
|-
  | style="font-weight: bold; padding-left:10px;"|Salisbury University
  | style="background-color:white; padding-left:10px;"|U.S. - MD (Salisbury)
  | style="background-color:white; padding-left:10px;"|[https://www.salisbury.edu/academic-offices/health-and-human-services/health-sciences/medical-laboratory-science/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers a B.S. in Medical Laboratory Science, as well as several associated minors
|-
  | style="font-weight: bold; padding-left:10px;"|San Francisco State University
  | style="background-color:white; padding-left:10px;"|U.S. - CA (San Francisco)
  | style="background-color:white; padding-left:10px;"|[https://cls.sfsu.edu/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"SF State's Clinical Laboratory Science (CLS) Internship Program offers a 14-month full-time program that combines 16 weeks of lecture and laboratory instruction on the campus, followed by a 40-week off-campus internship at an affiliated clinical laboratory site. Completion of the internship program is required for eligibility to national board certification examinations and the California Clinical Laboratory Scientist license."
|-
  | style="font-weight: bold; padding-left:10px;"|Saskatchewan Polytechnic
  | style="background-color:white; padding-left:10px;"|Canada - SK (Saskatoon)
  | style="background-color:white; padding-left:10px;"|[https://saskpolytech.ca/programs-and-courses/programs/Medical-Laboratory-Technology.aspx Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"Medical Laboratory Technology is a nationally accredited two-and-a-half-year diploma program offered at Saskatchewan Polytechnic in Saskatoon ... Graduates are eligible to write the Canadian Society for Medical Laboratory Science (CSMLS) General Medical Laboratory Technology certification exam. This entitles you to work anywhere in Canada and to register as a licensed Medical Laboratory Technologist with the Saskatchewan Society of Medical Laboratory Technologists (SSMLT)."
|-
  | style="font-weight: bold; padding-left:10px;"|Shoreline Community College
  | style="background-color:white; padding-left:10px;"|U.S. - WA (Shoreline)
  | style="background-color:white; padding-left:10px;"|[https://www.shoreline.edu/programs/medical-laboratory-technology/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers both an AAS and certificate in Medical Laboratory Technology
|-
  | style="font-weight: bold; padding-left:10px;"|South Dakota State University
  | style="background-color:white; padding-left:10px;"|U.S. - SD (Brookings)
  | style="background-color:white; padding-left:10px;"|[https://www.sdstate.edu/pharmacy-and-allied-health-professions/medical-laboratory-science Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers several B.S. in Medical Laboratory Science, as well as an upward mobility program and Phlebotomy certificate
|-
  | style="font-weight: bold; padding-left:10px;"|Southwest Minnesota State University
  | style="background-color:white; padding-left:10px;"|U.S. - MN (Marshall)
  | style="background-color:white; padding-left:10px;"|[https://www.smsu.edu/catalog/?program=53 Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers a B.S. in Medical Laboratory Science
|-
  | style="font-weight: bold; padding-left:10px;"|St. Clair College
  | style="background-color:white; padding-left:10px;"|Canada - ON (Windsor)
  | style="background-color:white; padding-left:10px;"|[https://www.stclaircollege.ca/programs/medical-laboratory-science Medical Laboratory Science Program]<br />[https://www.stclaircollege.ca/programs/medical-laboratory-technician Medical Laboratory Technician Program]
  | style="background-color:white; padding-left:10px;"|MLS: "Three Year - Ontario College Advanced Diploma"; MLT: "One Year - Ontario College Certificate (delivered in less than 1 year)"
|-
  | style="font-weight: bold; padding-left:10px;"|St. Cloud State University
  | style="background-color:white; padding-left:10px;"|U.S. - MN (St. Cloud)
  | style="background-color:white; padding-left:10px;"|[https://www.stcloudstate.edu/programs/medical-laboratory-science/default.aspx Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers a 3+1 or 2+2 bachelor program
|-
  | style="font-weight: bold; padding-left:10px;"|St. Edward's University
  | style="background-color:white; padding-left:10px;"|U.S. - TX (Austin)
  | style="background-color:white; padding-left:10px;"|[https://www.stedwards.edu/undergraduate/medical-laboratory-science Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers a B.S. + M.S.; "The University of Texas Medical Branch in Galveston has an agreement with St. Edward’s through which students can earn two degrees in five years. Students complete three years at St. Edward’s and two years of clinical training at UTMB. Through this program, you can earn a bachelor’s degree in Biology from St. Edward’s and a master’s degree in Clinical Laboratory Science from UTMB."
|-
  | style="font-weight: bold; padding-left:10px;"|St. Francis University
  | style="background-color:white; padding-left:10px;"|U.S. - PA (Loretto)
  | style="background-color:white; padding-left:10px;"|[https://catalog.francis.edu/preview_program.php?catoid=7&poid=1408 Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"The Bachelor of Health Science degree with a concentration in Medical Laboratory Science (B.H.S.M.L.S.) is a degree completion program designed to provide professional development and educational options for Medical Laboratory Technicians (MLTs)."
|-
  | style="font-weight: bold; padding-left:10px;"|St. John's University
  | style="background-color:white; padding-left:10px;"|U.S. - NY (Queens)
  | style="background-color:white; padding-left:10px;"|[https://www.stjohns.edu/academics/programs/clinical-laboratory-sciences-bachelor-science Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers a B.S. in Clinical Laboratory Sciences
|-
  | style="font-weight: bold; padding-left:10px;"|St. Lawrence College
  | style="background-color:white; padding-left:10px;"|Canada - ON (Kingston)
  | style="background-color:white; padding-left:10px;"|[https://www.stlawrencecollege.ca/programs/medical-laboratory-science/Full-Time/Kingston Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Three-year program to earn an Ontario College Advanced Diploma in Medical Laboratory Science
|-
  | style="font-weight: bold; padding-left:10px;"|St. Luke's College
  | style="background-color:white; padding-left:10px;"|U.S. - IA (Sioux City)
  | style="background-color:white; padding-left:10px;"|[https://www.stlukescollege.edu/certificate-in-medical-laboratory-science.aspx Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"The Medical Laboratory Science program at St. Luke's College will provide 11 months of professional studies committed to classroom and practical instruction. Clinical experience in the laboratory at UnityPoint Health - St. Luke's and MercyOne Siouxland Medical Center will help you work with accuracy and precision while performing diagnostic tests."
|-
  | style="font-weight: bold; padding-left:10px;"|St. Philip's College
  | style="background-color:white; padding-left:10px;"|U.S. - TX (San Antonio)
  | style="background-color:white; padding-left:10px;"|[https://www.alamo.edu/spc/academics/programs/health-sciences-and-histology/medical-laboratory-technician/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"The Medical Laboratory Technician (MLT) program prepares Health Science professionals to perform analysis on blood and body fluids to enable a physician to diagnose and monitor the treatment of diseases. The MLT program helps students obtain marketable skills for entry-level positions. Graduates earn an Associate of Applied Science Degree. "
|-
  | style="font-weight: bold; padding-left:10px;"|Stevenson University
  | style="background-color:white; padding-left:10px;"|U.S. - MD (Owings Mills)
  | style="background-color:white; padding-left:10px;"|[https://www.stevenson.edu/academics/undergraduate-programs/medical-laboratory-science/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers a B.S. and minor in Medical Laboratory Science
|-
  | style="font-weight: bold; padding-left:10px;"|Stony Brook University
  | style="background-color:white; padding-left:10px;"|U.S. - NY (Stony Brook)
  | style="background-color:white; padding-left:10px;"|[https://healthprofessions.stonybrookmedicine.edu/programs/clinical Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"The Clinical Laboratory Sciences Program at Stony Brook University is an upper-division program leading to a Bachelor of Science degree. Upon completion of the program, the graduates are eligible to take the National ASCP Board Certification Exam and are New York State License eligible."
|-
  | style="font-weight: bold; padding-left:10px;"|Tarleton State University
  | style="background-color:white; padding-left:10px;"|U.S. - TX (Fort Worth)
  | style="background-color:white; padding-left:10px;"|[https://www.tarleton.edu/medicallab/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offerings: Bachelor in Medical Laboratory Science (BS-MLS), Master of Science in Medical Laboratory Sciences (MS-MLS), Health Professions Technology (BAT-HPT), Public Health (BS in PH), Medical Laboratory Technician (AAS-MLT), Histotechnician (AAS-HT)
|-
  | style="font-weight: bold; padding-left:10px;"|Texas Tech University
  | style="background-color:white; padding-left:10px;"|U.S. - TX (Lubbock)
  | style="background-color:white; padding-left:10px;"|[https://www.ttuhsc.edu/health-professions/programs.aspx Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers two B.S. degrees in Clinical Laboratory Science, as well as a post-baccalaureate certificate
|-
  | style="font-weight: bold; padding-left:10px;"|Thomas More College
  | style="background-color:white; padding-left:10px;"|U.S. - KY (Crestview Hills)
  | style="background-color:white; padding-left:10px;"|[https://www.thomasmore.edu/program/medical-laboratory-science/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers a B.S. in Medical Laboratory Science
|-
  | style="font-weight: bold; padding-left:10px;"|Thomas Jefferson University
  | style="background-color:white; padding-left:10px;"|U.S. - PA (Philadelphia)
  | style="background-color:white; padding-left:10px;"|[https://www.jefferson.edu/academics/colleges-schools-institutes/health-professions/departments-programs/medical-laboratory-biotechnology/degrees-programs/bs-ms-programs/medical-laboratory.html Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers a variety of B.S. and M.S. programs in Medical Laboratory Science
|-
  | style="font-weight: bold; padding-left:10px;"|Thomas University
  | style="background-color:white; padding-left:10px;"|U.S. - GA (Thomasville)
  | style="background-color:white; padding-left:10px;"|[https://www.thomasu.edu/majors/bachelor-degrees/medical-laboratory-science/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Bachelor's options: 2+ 2 Online Option or Traditional Campus-Based Program
|-
  | style="font-weight: bold; padding-left:10px;"|University of Alabama at Birmingham
  | style="background-color:white; padding-left:10px;"|U.S. - AL (Birmingham)
  | style="background-color:white; padding-left:10px;"|[https://www.uab.edu/shp/cds/clinical-laboratory-sciences Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers an M.S. in Clinical Laboratory Sciences
|-
  | style="font-weight: bold; padding-left:10px;"|University of Alaska - Anchorage
  | style="background-color:white; padding-left:10px;"|U.S. - AK (Anchorage)
  | style="background-color:white; padding-left:10px;"|[https://www.uaa.alaska.edu/academics/college-of-health/departments/school-of-allied-health/academics/medical-laboratory-science/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offerings: Associate of Applied Science, Medical Laboratory Technology and Bachelor of Science, Medical Laboratory Science
|-
  | style="font-weight: bold; padding-left:10px;"|University of Alberta
  | style="background-color:white; padding-left:10px;"|Canada - AB (Edmonton)
  | style="background-color:white; padding-left:10px;"|[https://www.ualberta.ca/laboratory-medicine-and-pathology/divisions/medical-laboratory-science.html Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"This is a three year program at the University of Alberta with students admitted to the program after a minimum of one pre-professional year. Students graduate with a B.Sc. (MLS) and gain professional certification from the Canadian Society for Medical Laboratory Science."
|-
  | style="font-weight: bold; padding-left:10px;"|University of Arkansas for Medical Sciences
  | style="background-color:white; padding-left:10px;"|U.S. - AR (Little Rock)
  | style="background-color:white; padding-left:10px;"|[https://healthprofessions.uams.edu/programs/medicallaboratorysciences/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"The Medical Laboratory Sciences program offers a full or part-time track beginning each fall semester. Online students may be admitted in the spring.  The full-time track requires 17 months to complete. The program also offers an MLT-to-MLS distance track that is designed for medical laboratory technicians (MLTs) certified by the American Society for Clinical Pathology (ASCP) or equivalent agency. The MLT-to-MLS track can be completed in 3 semesters (full time) or 5 semesters (part time). Upon completion of the full-time, part-time, or MLT-to-MLS track, a Bachelor of Science in Medical Laboratory Sciences is awarded. The program also offers a non-degree option for those students not desiring a Bachelor of Science degree. Certification as an MLT or equivalent is preferred for non-degree students. The maximum number of credits that may be taken in this option is 24 hours."
|-
  | style="font-weight: bold; padding-left:10px;"|University of Bridgeport
  | style="background-color:white; padding-left:10px;"|U.S. - CT (Bridgeport)
  | style="background-color:white; padding-left:10px;"|[https://www.bridgeport.edu/academics/programs/mls-bs/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers a B.S. in Medical Laboratory Science
|-
  | style="font-weight: bold; padding-left:10px;"|University of British Columbia
  | style="background-color:white; padding-left:10px;"|Canada - BC (Vancouver)
  | style="background-color:white; padding-left:10px;"|[https://pathology.ubc.ca/educational-programs/bmlsc/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers a B.S. in Medical Laboratory Science
|-
  | style="font-weight: bold; padding-left:10px;"|University of California - Davis
  | style="background-color:white; padding-left:10px;"|U.S. - CA (Davis)
  | style="background-color:white; padding-left:10px;"|[https://health.ucdavis.edu/pathology/education/cls_training_program/information.html Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers a 12-month training program that results in a certificate. "The UC Davis Health CLS training program is a small hospital based program committed to providing well trained entry level Clinical Laboratory professionals to the greater Sacramento area and surrounding rural communities. To that end, the program preferentially selects applicants with ties to the greater Sacramento area or rural training partner sites located in Placerville, CA and Modesto, CA."
|-
  | style="font-weight: bold; padding-left:10px;"|University of Central Florida
  | style="background-color:white; padding-left:10px;"|U.S. - FL (Orlando)
  | style="background-color:white; padding-left:10px;"|[https://med.ucf.edu/biomed/undergraduate-programs/medical-laboratory-sciences/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers a B.S. in Medical Laboratory Sciences
|-
  | style="font-weight: bold; padding-left:10px;"|University of Cincinnati
  | style="background-color:white; padding-left:10px;"|U.S. - OH (Cincinnati)
  | style="background-color:white; padding-left:10px;"|[https://cahs.uc.edu/academic-programs/undergraduate-programs/medical-laboratory-science.html Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"The University of Cincinnati's Medical Laboratory Science program has several program track and certificiate options for you to choose from."
|-
  | style="font-weight: bold; padding-left:10px;"|University of Colorado - Colorado Springs
  | style="background-color:white; padding-left:10px;"|U.S. - CO (Colorado Springs)
  | style="background-color:white; padding-left:10px;"|[https://johnsonbethel.uccs.edu/health-sciences-programs Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers a B.S. and certificate in Medical Laboratory Sciences
|-
  | style="font-weight: bold; padding-left:10px;"|University of Connecticut
  | style="background-color:white; padding-left:10px;"|U.S. - CT (Storrs)
  | style="background-color:white; padding-left:10px;"|[https://mls.alliedhealth.uconn.edu/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers a B.S. and certificate in Medical Laboratory Sciences
|-
  | style="font-weight: bold; padding-left:10px;"|University of Deleware
  | style="background-color:white; padding-left:10px;"|U.S. - DE (Newark)
  | style="background-color:white; padding-left:10px;"|[https://www.udel.edu/academics/colleges/chs/departments/mms/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers a B.S. and M.S. in Medical Laboratory Sciences
|-
  | style="font-weight: bold; padding-left:10px;"|University of Findlay
  | style="background-color:white; padding-left:10px;"|U.S. - OH (Findlay)
  | style="background-color:white; padding-left:10px;"|[https://www.findlay.edu/health-professions/medical-laboratory-science/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"The University of Findlay's MLS program will prepare you to enter an accredited clinical education training program. The program includes courses that are required for certification as well as the general education requirements needed for a bachelor of science degree. When completing the bachelor of science degree with a major in medical laboratory science, you are also earning a minor in biology and are only one course away from earning a minor in chemistry."
|-
  | style="font-weight: bold; padding-left:10px;"|University of Indianapolis
  | style="background-color:white; padding-left:10px;"|U.S. - IN (Indianapolis)
  | style="background-color:white; padding-left:10px;"|[https://www.uindy.edu/cas/chemistry/medical-laboratory-science Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"The medical laboratory science degree program is highly competitive, requiring three years of coursework at UIndy and completion of a 12-month clinical training program in a hospital laboratory during the fourth year of undergraduate study."
|-
  | style="font-weight: bold; padding-left:10px;"|University of Iowa Carver College of Medicine
  | style="background-color:white; padding-left:10px;"|U.S. - IA (Iowa City)
  | style="background-color:white; padding-left:10px;"|[https://medicine.uiowa.edu/pathology/education/medical-laboratory-science-program-mlsp Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"University of Iowa's Roy J. and Lucille A. Carver College of Medicine offers a bachelor's degree in medical laboratory sciences through an affiliation with Allen College in Waterloo, Iowa. The program provides patient-centered educational opportunities, with theoretical knowledge and practical experience in hematology, clinical chemistry, microbiology, immunohematology, immunology, endocrinology, and molecular diagnostics. Students can enroll in the program as the final year of a bachelor’s degree or as an additional year following receipt of a bachelor’s degree."
|-
  | style="font-weight: bold; padding-left:10px;"|University of Kansas
  | style="background-color:white; padding-left:10px;"|U.S. - KS (Kansas City)
  | style="background-color:white; padding-left:10px;"|[https://www.kumc.edu/school-of-health-professions/academics/departments/clinical-laboratory-sciences.html Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers a B.S., M.S., and Doctorate in Clinical Laboratory Science
|- 
  | style="font-weight: bold; padding-left:10px;"|University of Kentucky
  | style="background-color:white; padding-left:10px;"|U.S. - KY (Lexington)
  | style="background-color:white; padding-left:10px;"|[https://www.uky.edu/chs/medical-laboratory-science Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Track Options: Second B.S. Degree, Transfer Students, Online MLT to MLS
|-
  | style="font-weight: bold; padding-left:10px;"|University of Louisiana at Monroe
  | style="background-color:white; padding-left:10px;"|U.S. - LA (Monroe)
  | style="background-color:white; padding-left:10px;"|[https://www.ulm.edu/mls/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"The program is a minimum four-year curriculum, which includes a solid foundation in basic sciences, a broad background in medical laboratory science with several specialized courses..."
|- 
  | style="font-weight: bold; padding-left:10px;"|University of Maine
  | style="background-color:white; padding-left:10px;"|U.S. - ME (Orono)
  | style="background-color:white; padding-left:10px;"|[https://sbe.umaine.edu/undergraduate/clinical-lab-sciences/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers a B.S. in Medical Laboratory Science
|-
  | style="font-weight: bold; padding-left:10px;"|University of Mary
  | style="background-color:white; padding-left:10px;"|U.S. - ND (Bismarck)
  | style="background-color:white; padding-left:10px;"|[https://www.umary.edu/academics/undergraduate-programs/medical-laboratory-science Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers a B.S. or B.A. in Medical Laboratory Science
|-
  | style="font-weight: bold; padding-left:10px;"|University of Maryland
  | style="background-color:white; padding-left:10px;"|U.S. - MD (Baltimore)
  | style="background-color:white; padding-left:10px;"|[https://www.medschool.umaryland.edu/dmrt/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers a B.S. in Medical Laboratory Science and M.S. in Laboratory Management
|-
  | style="font-weight: bold; padding-left:10px;"|University of Massachusetts - Dartmouth
  | style="background-color:white; padding-left:10px;"|U.S. - MA (Dartmouth)
  | style="background-color:white; padding-left:10px;"|[https://www.umassd.edu/nursing/medlab/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"UMass Dartmouth offers a Bachelor of Science Degree in Medical Laboratory Science. All graduates meet requirements for national certification or state licensure."
|-
  | style="font-weight: bold; padding-left:10px;"|University of Minnesota
  | style="background-color:white; padding-left:10px;"|U.S. - MN (Minneapolis)
  | style="background-color:white; padding-left:10px;"|[https://www.alliedhealth.umn.edu/mls Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"The University of Minnesota’s Medical Laboratory Sciences program is the only accredited 4-year baccalaureate degree program in a public institution in the State of Minnesota."
|-
  | style="font-weight: bold; padding-left:10px;"|University of Mississippi
  | style="background-color:white; padding-left:10px;"|U.S. - MS (Jackson)
  | style="background-color:white; padding-left:10px;"|[https://www.umc.edu/shrp/Medical%20Laboratory%20Science/Medical-Laboratory-Science.html Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"The Department of Clinical and Diagnostic Sciences offers two types of Medical Laboratory Science bachelor degree programs to assist students with their career goals": a traditional B.S. and an  MLT-MLS advanced standing bachelor degree program.
|-
  | style="font-weight: bold; padding-left:10px;"|University of Missouri - Columbia
  | style="background-color:white; padding-left:10px;"|U.S. - MO (Columbia)
  | style="background-color:white; padding-left:10px;"|[https://healthprofessions.missouri.edu/clinical-laboratory-science/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers a B.S. and M.S. in Clinical Laboratory Science
|-
  | style="font-weight: bold; padding-left:10px;"|University of Montana - Missoula
  | style="background-color:white; padding-left:10px;"|U.S. - MT (Missoula)
  | style="background-color:white; padding-left:10px;"|[https://hs.umt.edu/medtech/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"Both UM and MSU offer 3+1 or 4+1 curriculum options. Either course of study results in a B.S. degree in Medical Laboratory Science (UM) or Microbiology with an emphasis in Medical Laboratory Science (MSU)."
|-
  | style="font-weight: bold; padding-left:10px;"|University of Mount Union
  | style="background-color:white; padding-left:10px;"|U.S. - OH (Alliance)
  | style="background-color:white; padding-left:10px;"|[https://www.mountunion.edu/medical-laboratory-science Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"The Bachelor of Science degree in medical laboratory science at the University of Mount Union combines three years of on-campus study with a final year of professional training in medical technology and laboratory science at one of our affiliated hospital-based schools. This clinical year amounts to 2,000 hours of intense study and lab experience, culminating in a comprehensive examination."
|-
  | style="font-weight: bold; padding-left:10px;"|University of New Brunswick
  | style="background-color:white; padding-left:10px;"|Canada - NB (Fredericton/St. John)
  | style="background-color:white; padding-left:10px;"|[https://www.unb.ca/academics/programs/medical-laboratory-science/medical-laboratory-science.html Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"The BMLS degree requires completion of the MLT program either prior to or after completion of 84 credit hours of courses at UNB. For graduation, students must have completed the UNB portion of the degree as well as 2.5 years of the MLT program at NBCC-SJ and have passed the Canadian Society for Medical Laboratory Science (CSMLS) exams required for professional practice."
|-
  | style="font-weight: bold; padding-left:10px;"|University of New Hampshire
  | style="background-color:white; padding-left:10px;"|U.S. - NH (Durham)
  | style="background-color:white; padding-left:10px;"|[https://colsa.unh.edu/molecular-cellular-biomedical-sciences/program/bs/biomedical-science-major-medical-laboratory-science-option Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"UNH has the only four-year, NAACLS-accredited medical laboratory science program in New Hampshire, giving students a path to become certified medical laboratory scientists with the American Society of Clinical Pathology."
|-
  | style="font-weight: bold; padding-left:10px;"|University of New Mexico
  | style="background-color:white; padding-left:10px;"|U.S. - NM (Albuquerque)
  | style="background-color:white; padding-left:10px;"|[https://hsc.unm.edu/medicine/departments/pathology/medical-laboratory-sciences/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers a B.S. in Medical Laboratory Science
|-
  | style="font-weight: bold; padding-left:10px;"|University of North Carolina at Chapel Hill
  | style="background-color:white; padding-left:10px;"|U.S. - NC (Chapel Hill)
  | style="background-color:white; padding-left:10px;"|[https://www.med.unc.edu/ahs/clinical/about-us/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers a B.S. and M.S. in Clinical Laboratory Science
|-
  | style="font-weight: bold; padding-left:10px;"|University of North Dakota
  | style="background-color:white; padding-left:10px;"|U.S. - ND (Grand Forks)
  | style="background-color:white; padding-left:10px;"|[https://med.und.edu/medical-laboratory-science/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"We issue a bachelor's degree and/or certificate in MLS through six different routes of study."
|-
  | style="font-weight: bold; padding-left:10px;"|University of North Texas
  | style="background-color:white; padding-left:10px;"|U.S. - TX (Denton)
  | style="background-color:white; padding-left:10px;"|[https://biology.unt.edu/undergraduate-programs/medical-laboratory-sciences-program Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"Students complete a minimum of 88 semester hours at UNT prior to entering clinical training. Then students must enroll in a minimum of 12 months of clinical training (for a minimum of 32 semester hours) at any hospital or university laboratory approved by the National Accrediting Agency for Clinical Laboratory Sciences."
|-
  | style="font-weight: bold; padding-left:10px;"|University of Ontario Institute of Technology
  | style="background-color:white; padding-left:10px;"|Canada - ON (Toronto)
  | style="background-color:white; padding-left:10px;"|[https://ontariotechu.ca/programs/undergraduate/medicine-and-health/medical-laboratory-science/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers a Bachelor of Health Science (Honours) in Medical Laboratory Science
|-
  | style="font-weight: bold; padding-left:10px;"|University of Regina
  | style="background-color:white; padding-left:10px;"|Canada - SK (Regina)
  | style="background-color:white; padding-left:10px;"|[https://www.uregina.ca/science/programs/other.html Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers a B.S. in Medical Laboratory Science
|-
  | style="font-weight: bold; padding-left:10px;"|University of South Dakota
  | style="background-color:white; padding-left:10px;"|U.S. - SD (Vermillion)
  | style="background-color:white; padding-left:10px;"|[https://catalog.usd.edu/preview_program.php?catoid=19&poid=2764 Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"Students spend 3 years on the USD campus completing medical laboratory science major requirements, university degree requirements, general education, and the fourth year is spent at an affiliated School of Medical Laboratory Science where students complete their clinical requirements. The program culminates in a Bachelor of Science degree from the USD School of Health Sciences."
|-
  | style="font-weight: bold; padding-left:10px;"|University of Southern Mississippi
  | style="background-color:white; padding-left:10px;"|U.S. - MS (Hattiesburg)
  | style="background-color:white; padding-left:10px;"|[https://www.usm.edu/biological-environmental-earth-sciences/programs-medical-laboratory-science.php Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers a B.S. and M.S. in Medical Laboratory Science
|-
  | style="font-weight: bold; padding-left:10px;"|University of Tennessee
  | style="background-color:white; padding-left:10px;"|U.S. - TN (Memphis)
  | style="background-color:white; padding-left:10px;"|[https://www.uthsc.edu/health-professions/diagnostic-health-sciences/mls/index.php Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offerings: B.S., M.S., and an online MLT to MLS program
|-
  | style="font-weight: bold; padding-left:10px;"|University of Tennessee - Knoxville
  | style="background-color:white; padding-left:10px;"|U.S. - TN (Knoxville)
  | style="background-color:white; padding-left:10px;"|[https://artsci.utk.edu/future-students/pre-health/allied-health-programs/medical-laboratory-sciencemedical-technology/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers a B.S. in Medical Laboratory Science
|-
  | style="font-weight: bold; padding-left:10px;"|University of Texas - MD Anderson Cancer Center
  | style="background-color:white; padding-left:10px;"|U.S. - TX (Houston)
  | style="background-color:white; padding-left:10px;"|[https://www.mdanderson.org/education-training/degrees-programs/school-of-health-professions/academics/clinical-laboratory-science/curriculum.html Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers a B.S. in Clinical Laboratory Science
|-
  | style="font-weight: bold; padding-left:10px;"|University of Texas - Rio Grande Valley
  | style="background-color:white; padding-left:10px;"|U.S. - TX (Edinburg)
  | style="background-color:white; padding-left:10px;"|[https://www.utrgv.edu/hbs/undergraduate-programs/cls/index.htm Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers a B.S. in Medical Laboratory Science
|-
  | style="font-weight: bold; padding-left:10px;"|University of Texas at Austin
  | style="background-color:white; padding-left:10px;"|U.S. - TX (Austin)
  | style="background-color:white; padding-left:10px;"|[https://cns.utexas.edu/biosciences-advising-center/advising/medical-laboratory-science Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"The Medical Laboratory Science degree at UT is a 3+1 program. Students take 3 years of courses at UT, and their final 12-16 months off campus at one of UT’s affiliate clinical programs. MLS majors take a variety of Biology, Biochemistry, and Chemistry courses before their clinical program. After completing UT coursework and the clinical program, students take their ASCP exams and receive their Bachelor of Science degree from UT."
|-
  | style="font-weight: bold; padding-left:10px;"|University of Texas Health Science Center at San Antonio
  | style="background-color:white; padding-left:10px;"|U.S. - TX (San Antonio)
  | style="background-color:white; padding-left:10px;"|[https://www.uthscsa.edu/academics/health-professions/programs Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers a B.S. and M.S. in Medical Laboratory Science
|-
  | style="font-weight: bold; padding-left:10px;"|University of Texas Medical Branch at Galveston
  | style="background-color:white; padding-left:10px;"|U.S. - TX (Galveston)
  | style="background-color:white; padding-left:10px;"|[https://www.utmb.edu/shp/clls/academics Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offerings: B.S., M.S., Doctoral and a categorical certification program
|-
  | style="font-weight: bold; padding-left:10px;"|University of the Sciences in Philadelphia
  | style="background-color:white; padding-left:10px;"|U.S. - PA (Philadelphia)
  | style="background-color:white; padding-left:10px;"|[https://www.usciences.edu/misher-college-of-arts-and-sciences/biological-sciences/medical-laboratory-science-major/index.html Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers a B.S. in Medical Laboratory Science
|-
  | style="font-weight: bold; padding-left:10px;"|University of Utah
  | style="background-color:white; padding-left:10px;"|U.S. - UT (Salt Lake City)
  | style="background-color:white; padding-left:10px;"|[https://pathology.utahhealth.acsitefactory.com/pathology/medical-laboratory-sciencesMedical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers several B.S. in Medical Laboratory Science, as well as certificates and an M.S.
|-
  | style="font-weight: bold; padding-left:10px;"|University of Vermont
  | style="background-color:white; padding-left:10px;"|U.S. - VT (Burlington)
  | style="background-color:white; padding-left:10px;"|[https://www.uvm.edu/cnhs/bhsc?Page=mls_program.html Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers a B.S. and M.S. in Medical Laboratory Science
|-
  | style="font-weight: bold; padding-left:10px;"|University of Washington
  | style="background-color:white; padding-left:10px;"|U.S. - WA (Seattle)
  | style="background-color:white; padding-left:10px;"|[https://dlmp.uw.edu/education/mls-undergrad Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"The MLS Program is a full-time, four-year course of study and is divided into two major parts: the Pre-professional Phase and the Professional Phase ... Graduates of the program earn a Bachelor of Science degree in Medical Laboratory Science."
|-
  | style="font-weight: bold; padding-left:10px;"|University of West Florida
  | style="background-color:white; padding-left:10px;"|U.S. - FL (Pensacola)
  | style="background-color:white; padding-left:10px;"|[https://uwf.edu/ukcoh/departments/medical-laboratory-sciences/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers a B.S., MLT-MLS B.S., and certificate program in Medical/Clinical Laboratory Sciences
|-
  | style="font-weight: bold; padding-left:10px;"|University of Wisconsin - La Crosse
  | style="background-color:white; padding-left:10px;"|U.S. - WI (La Crosse)
  | style="background-color:white; padding-left:10px;"|[http://catalog.uwlax.edu/undergraduate/clinicallaboratoryscience/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"The curriculum requires a minimum of six semesters and a summer session on campus to complete the pre-professional and pre-clinical courses. Students spend an additional nine months of clinical education in a hospital-sponsored, accredited program during their senior year. A Bachelor of Science degree is awarded at the satisfactory completion of all required course work."
|-
  | style="font-weight: bold; padding-left:10px;"|University of Wisconsin - Milwaukee
  | style="background-color:white; padding-left:10px;"|U.S. - WI (Milwaukee)
  | style="background-color:white; padding-left:10px;"|[https://uwm.edu/healthsciences/academics/bs-medical-laboratory-science/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers a B.S. in Medical Laboratory Science
|-
  | style="font-weight: bold; padding-left:10px;"|University of Wisconsin - Stevens Point
  | style="background-color:white; padding-left:10px;"|U.S. - WI (Stevens Point)
  | style="background-color:white; padding-left:10px;"|[https://www3.uwsp.edu/health/Pages/Major/cls.aspx Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers a B.S. in Clinical Laboratory Science
|-
  | style="font-weight: bold; padding-left:10px;"|University of Wyoming - Casper
  | style="background-color:white; padding-left:10px;"|U.S. - WY (Casper)
  | style="background-color:white; padding-left:10px;"|[https://www.uwyo.edu/pharmacy/mls-program/index.html Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"The MLS program is composed of 60 credit hours of course work between the junior and senior years, with the final semester being reserved for advanced clinical practicum courses. The program curriculum is based on major requirements of the University of Wyoming’s School of Health Science, and program specific requirements for NAACLS accreditation."
|-
  | style="font-weight: bold; padding-left:10px;"|Utah Tech University
  | style="background-color:white; padding-left:10px;"|U.S. - UT (St. George)
  | style="background-color:white; padding-left:10px;"|[https://health.utahtech.edu/mls/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers a B.S. in Medical Laboratory Science
|-
  | style="font-weight: bold; padding-left:10px;"|Virginia Commonwealth University
  | style="background-color:white; padding-left:10px;"|U.S. - VA (Richmond)
  | style="background-color:white; padding-left:10px;"|[https://mls.chp.vcu.edu/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offerings: B.S., M.S., and Ph.D.
|-
  | style="font-weight: bold; padding-left:10px;"|Wallace State Community College
  | style="background-color:white; padding-left:10px;"|U.S. - AL (Hanceville)
  | style="background-color:white; padding-left:10px;"|[https://www.wallacestate.edu/programs/health-division/clinical-laboratory-technician/index.html Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers an A.A.S. in Medical Laboratory Technician
|-
  | style="font-weight: bold; padding-left:10px;"|Washburn University
  | style="background-color:white; padding-left:10px;"|U.S. - KS (Topeka)
  | style="background-color:white; padding-left:10px;"|[https://www.washburn.edu/academics/college-schools/applied-studies/departments/allied-health/bhs/cls/index.html Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers a B.S. in Medical Laboratory Science
|-
  | style="font-weight: bold; padding-left:10px;"|Washington Adventist University
  | style="background-color:white; padding-left:10px;"|U.S. - MD (Takoma Park)
  | style="background-color:white; padding-left:10px;"|[https://www.wau.edu/academics/undergraduate-programs/medlab-department/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"The medical laboratory science program consists of three years of study at Washington Adventist University, followed by a 12- or 13-month senior year in a hospital-based medical laboratory science program. The hospital program affiliated with Washington Adventist University is Andrews University, which is accredited by the National Accrediting Agency for Clinical Laboratory Sciences.
|-
  | style="font-weight: bold; padding-left:10px;"|Wayne State University
  | style="background-color:white; padding-left:10px;"|U.S. - MI (Detroit)
  | style="background-color:white; padding-left:10px;"|[https://cphs.wayne.edu/clinical-laboratory-science/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers a B.S. in Clinical Laboratory Science
|-
  | style="font-weight: bold; padding-left:10px;"|Weber State University
  | style="background-color:white; padding-left:10px;"|U.S. - UT (Ogden)
  | style="background-color:white; padding-left:10px;"|[https://www.weber.edu/mls Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers a B.S., AAS, and certificate in Medical Laboratory Science
|-
  | style="font-weight: bold; padding-left:10px;"|West Liberty University
  | style="background-color:white; padding-left:10px;"|U.S. - WV (West Liberty)
  | style="background-color:white; padding-left:10px;"|[https://westliberty.edu/health-sciences/academics/clinical-laboratory-science/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"The Medical Laboratory Science (MLS) Program at WLU is a 2+2 program. The freshman and sophomore years are devoted to studying basic science and general study courses. Near the completion of the sophomore year, students may apply for admission into the MLS Program ... Progression through the program is contingent upon the student passing all required coursework in general studies and clinical laboratory science, and successfully completing the clinical practicum (or rotations) at our clinical affiliates"
|-
  | style="font-weight: bold; padding-left:10px;"|West Virginia University
  | style="background-color:white; padding-left:10px;"|U.S. - WV (Morgantown)
  | style="background-color:white; padding-left:10px;"|[https://medicine.wvu.edu/biomedical-laboratory-diagnostics/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"The WVU Bachelor of Science in Medical Laboratory Science, is a four-year program..." with two areas of emphasis: clinical laboratory scientist and histotechnologist.
|- 
  | style="font-weight: bold; padding-left:10px;"|Western Dakota Technical College
  | style="background-color:white; padding-left:10px;"|U.S. - SD (Rapid City)
  | style="background-color:white; padding-left:10px;"|[https://www.wdt.edu/degree-programs/medical-laboratory-technician/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|The technical college offers an A.A.S. in Medical Laboratory Technician.
|-
  | style="font-weight: bold; padding-left:10px;"|Wichita State University
  | style="background-color:white; padding-left:10px;"|U.S. - KS (Wichita)
  | style="background-color:white; padding-left:10px;"|[https://www.wichita.edu/academics/health_professions/mls/bmls.phpMedical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|B.S. program: "The 17-month professional phase consists of 12 months of instruction on the WSU campus and 5 months clinical practice at a medical facility."
|-
  | style="font-weight: bold; padding-left:10px;"|Wilkes University
  | style="background-color:white; padding-left:10px;"|U.S. - PA (Wilkes-Barre)
  | style="background-color:white; padding-left:10px;"|[https://www.wilkes.edu/academics/colleges/science-and-engineering/center-for-health-sciences-and-student-success/traditional-pre-health-programs/medical-laboratory-science.aspx Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Offers a B.S. in Medical Laboratory Science (3+1)
|-
  | style="font-weight: bold; padding-left:10px;"|Wright State University
  | style="background-color:white; padding-left:10px;"|U.S. - OH (Dayton)
  | style="background-color:white; padding-left:10px;"|[https://science-math.wright.edu/biology/bachelor-of-science-in-medical-laboratory-science Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|Bachelor program: "The Medical Laboratory Science program includes three years of study at Wright State and a one-year clinical laboratory curriculum accredited by the American Medical Association Council on Medical Education through the National Accrediting Agency of Clinical Laboratory Sciences (NAACLS)."
|-
  | style="font-weight: bold; padding-left:10px;"|York College of Pennsylvania
  | style="background-color:white; padding-left:10px;"|U.S. - PA (York)
  | style="background-color:white; padding-left:10px;"|[https://www.ycp.edu/academics/dr-donald-e-and-lois-j-myers-school-of-nursing-and-health-professions/programs/medical-laboratory-science/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"During your junior year, you will apply for clinicals at an accredited program to be completed during your senior year. You can choose to apply at one of our five affiliated programs or another accredited clinical program in the United States. Upon completion of the Medical Laboratory Science program at York College, you will be required to pass the Medical Lab Scientist (ASCP) Certification."
|-
  | style="font-weight: bold; padding-left:10px;"|Youngstown State University
  | style="background-color:white; padding-left:10px;"|U.S. - OH (Youngstown)
  | style="background-color:white; padding-left:10px;"|[https://ysu.edu/academics/bitonte-college-health-and-human-services/medical-laboratory-science-major Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"This "3+1" program allows you to take courses in the classroom to broaden your understanding before moving on to spend your final year doing hands-on laboratory work through an MLS-accredited hospital program."
|-
|}
|}


'''One-year hospital-based programs'''
These and other questions are addressed in this chapter.


{|
====3.1.1 Technology considerations====
| STYLE="vertical-align:top;"|
Your laboratory's [[workflow]], instruments, data management requirements, budget, technological expertise, business goals, and risk tolerances will all play a role in deciding what technology to invest in. The allergen, calorie, and nutrition testing lab, for example, may depend less on instrument integration than the stability, cycle, and challenge testing lab, with its microbiological workflows. As such, look at your laboratory's short- and long-term goals, budget, workflow, and regulatory requirements to gain a better understanding of what technology will be involved.
{| class="wikitable collapsible sortable" border="1" cellpadding="5" cellspacing="0" width="60%"
|-
  ! colspan="4"| One-year hospital-based programs
|-
  ! style="color:brown; background-color:#ffffee;"| School/Hospital
  ! style="color:brown; background-color:#ffffee;"| Location
  ! style="color:brown; background-color:#ffffee;"| Program
  ! style="color:brown; background-color:#ffffee;"| Description
|- 
  | style="font-weight: bold; padding-left:10px;"|Akron Children's Hospital
  | style="background-color:white; padding-left:10px;"|U.S. - OH (Akron)
  | style="background-color:white; padding-left:10px;"|[https://www.akronchildrens.org/pages/Akron-Cooperative-Medical-Laboratory-Science-Program.html Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"The Akron Cooperative Medical Laboratory Science Program (ACMLSP or MLS Program) is a collaborative effort among Akron Children’s Hospital and Summa Health."
|-
  | style="font-weight: bold; padding-left:10px;"|Altoona Regional
  | style="background-color:white; padding-left:10px;"|U.S. - PA (Altoona)
  | style="background-color:white; padding-left:10px;"|[https://www.upmc.com/locations/hospitals/altoona/careers-training/school-med-tech Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"UPMC Altoona School of Medical Technology/Medical Laboratory Science is an accredited, 50-week internship program offering clinical theoretical concepts with clinical experience."
|-
  | style="font-weight: bold; padding-left:10px;"|Arrowhead Regional Medical Center
  | style="background-color:white; padding-left:10px;"|U.S. - CA (Colton)
  | style="background-color:white; padding-left:10px;"|[https://www.arrowheadregional.org/education-research/the-school-of-medical-technology/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"Students rotate through all areas of the laboratory during the 12-month (40 hours per week) training program. The program includes both lectures and clinical training. The program charges no tuition. Students receive a certificate upon completion of the program. Successful completion qualifies students to sit for a national certification exam and/or California licensure."
|-
  | style="font-weight: bold; padding-left:10px;"|Ascension St. Vincent's Jacksonville
  | style="background-color:white; padding-left:10px;"|U.S. - FL (Jacksonville)
  | style="background-color:white; padding-left:10px;"|[https://jaxmeded.com/en/schools-of-medical-science/medical-laboratory-science Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"As a hospital based program, acceptance into the program guarantees clinical placement.  The curriculum includes 50 weeks of instruction with classes starting each year in January and late June. Each class has a maximum capacity of five students."
|-
  | style="font-weight: bold; padding-left:10px;"|Augusta Health
  | style="background-color:white; padding-left:10px;"|U.S. - VA (Fishersville)
  | style="background-color:white; padding-left:10px;"|[https://www.augustahealth.com/service/laboratory/cls/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"The program is rigorous and consists of over 1500 clock hours of instruction which is equivalent to 40 semester-credit hours. It is intended to provide didactic and practical instruction in the field of clinical laboratory science to prepare program graduates to sit for the national certification exam. "
|-
  | style="font-weight: bold; padding-left:10px;"|Austin State Hospital
  | style="background-color:white; padding-left:10px;"|U.S. - TX (Austin)
  | style="background-color:white; padding-left:10px;"|[https://www.hhs.texas.gov/services/mental-health-substance-use/state-hospitals/austin-state-hospital/medical-laboratory-science-program Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"The program is designed to instruct students in academic and practical phases of laboratory medicine. Graduates are eligible to take the Medical Laboratory Scientist Board of Certification examination given by the American Society for Clinical Pathology."
|-
  | style="font-weight: bold; padding-left:10px;"|Baptist Medical Center South
  | style="background-color:white; padding-left:10px;"|U.S. - AL (Montgomery)
  | style="background-color:white; padding-left:10px;"|[https://www.baptistfirst.org/education/school-of-medical-laboratory-science Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"Baptist Health offers a one-year hospital-based medical technology internship ... After successful completion of the internship the affiliated university awards the bachelor's degree ... The School of Medical Laboratory Science is affiliated with Auburn University and Troy University."
|-
  | style="font-weight: bold; padding-left:10px;"|Baylor Scott & White Medical Center - Temple
  | style="background-color:white; padding-left:10px;"|U.S. - TX (Temple)
  | style="background-color:white; padding-left:10px;"|[https://www.bswhealth.med/education/Pages/allied-health/temple/clinical-laboratory-science.aspx Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"The Baylor Scott & White Medical Center - Temple Program in Medical Laboratory Science (MLS) is a one-year training program for students who have a bachelor's degree in the sciences (4+1) or who are currently enrolled in a clinical laboratory science, medical laboratory science or medical technology degree program (3+1)."
|-
  | style="font-weight: bold; padding-left:10px;"|Beaumont Hospital
  | style="background-color:white; padding-left:10px;"|U.S. - MI (Royal Oak)
  | style="background-color:white; padding-left:10px;"|[https://www.beaumont.edu/other-education/allied-health/medical-laboratory-science-44-week-program Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"This 44-week clinical laboratory education program is designed for post-baccalaureate, non-MLS degree candidates. The inaugural class began in January 2022."
|-
  | style="font-weight: bold; padding-left:10px;"|Cleveland Clinic
  | style="background-color:white; padding-left:10px;"|U.S. - OH (Cleveland)
  | style="background-color:white; padding-left:10px;"|[https://my.clevelandclinic.org/departments/pathology/medical-professionals/school-medical-technology Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"The program consists of 47 weeks of lecture and laboratory experience ... The courses include lectures, student lab and clinical lab experience. Cleveland Clinic’s Main Campus Hospital and Akron General are the two locations for the clinical lab experience."
|- 
  | style="font-weight: bold; padding-left:10px;"|Community Healthcare System Central Laboratory
  | style="background-color:white; padding-left:10px;"|U.S. - IN (Munster)
  | style="background-color:white; padding-left:10px;"|[https://www.comhs.org/careers/professional-development/school-of-medical-lab-science Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"...the School of Medical Laboratory Science, an 11-month program designed for baccalaureate graduates in the biological sciences or 3+1 option for students at Purdue University Northwest and Calumet College of St. Joseph."
|-
  | style="font-weight: bold; padding-left:10px;"|Conemaugh Memorial Medical Center
  | style="background-color:white; padding-left:10px;"|U.S. - PA (Johnstown)
  | style="background-color:white; padding-left:10px;"|[https://www.conemaugh.org/conemaugh-school-of-medical-laboratory-science Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"Conemaugh School of Medical Laboratory Science offers a 48-week program that provides theoretical and clinical training for qualified, academically prepared students."
|-
  | style="font-weight: bold; padding-left:10px;"|Denver Health School of Medical Laboratory Science
  | style="background-color:white; padding-left:10px;"|U.S. - CO (Denver)
  | style="background-color:white; padding-left:10px;"|[https://www.denverhealth.org/for-professionals/office-of-education/health-professions-and-pre-health-programs/school-of-medical-laboratory-science Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"The School of Medical Laboratory Science is an 11-month hospital-based education program, offered by Denver Health, designed to provide theoretical knowledge and student and clinical laboratory experiences in all laboratory disciplines. The program begins in early January and finishes in mid-November."
|-
  | style="font-weight: bold; padding-left:10px;"|DMC University Laboratories
  | style="background-color:white; padding-left:10px;"|U.S. - MI (Detroit)
  | style="background-color:white; padding-left:10px;"|[https://www.dmc.org/health-professionals/university-labs/medical-laboratory-scientist-program Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"The program accepts 10 students each year for 36 weeks of practical training. Both degree and non degree students are acceptable, providing admission criteria are met."
|- 
  | style="font-weight: bold; padding-left:10px;"|Eisenhower Health
  | style="background-color:white; padding-left:10px;"|U.S. - CA (Rancho Mirage)
  | style="background-color:white; padding-left:10px;"|[https://eisenhowerhealth.org/about-us/school-of-medical-laboratory-science/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"Students spend 12 months learning the specialties of each area of the clinical laboratory. Interpersonal skills are fostered through interactions with patients, physicians, clients, and colleagues ... Our CLS/MLS program is 52 weeks long and begins every September. Students are required to attend classes 40 hours per week, Monday through Friday, excluding holidays."
|-
  | style="font-weight: bold; padding-left:10px;"|Evanston Hospital
  | style="background-color:white; padding-left:10px;"|U.S. - IL (Evanston)
  | style="background-color:white; padding-left:10px;"|[https://www.northshore.org/academics/academic-programs/other-programs/medical-technology/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"The goal of the Program is to prepare competent men and women for the profession of Medical Laboratory Scientist. This goal is accomplished through the student’s participation in a curriculum that includes a 6 week basic laboratory course as well as clinical rotations and didactic instruction in each laboratory specialty."
|-
  | style="font-weight: bold; padding-left:10px;"|Franciscan St. Francis Health - Indianapolis
  | style="background-color:white; padding-left:10px;"|U.S. - IN (Indianapolis)
  | style="background-color:white; padding-left:10px;"|[https://www.franciscanhealth.org/healthcare-professionals/education/clinical-laboratory-science-program Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"The program accepts students in the final year of a baccalaureate degree program at an affiliated college or university, or those with a bachelor's degree. Students earn 32 college credit hours and receive eight hours of instruction a day. Credit can be transferred to an affiliated college or university to fulfill requirements for a bachelor of science degree."
|-
  | style="font-weight: bold; padding-left:10px;"|Guthrie Robert Packer Hospital
  | style="background-color:white; padding-left:10px;"|U.S. - PA (Sayre)
  | style="background-color:white; padding-left:10px;"|[https://www.guthrie.org/medical-laboratory-sciences Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"The Medical Laboratory Sciences program combines a high caliber education with a state-of-the-art learning environment to provide a 50-week internship, on top of 3-4 years of college. Upon successful completion of the internship, the student receives a baccalaureate degree from their affiliated university and a certificate in Clinical Laboratory Sciences from the Program."
|-
  | style="font-weight: bold; padding-left:10px;"|Hennepin County Medical Center
  | style="background-color:white; padding-left:10px;"|U.S. - MN (Minneapolis)
  | style="background-color:white; padding-left:10px;"|[https://www.hennepinhealthcare.org/medical-education-training/laboratory-education/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"The Medical Laboratory Science program accepts students from MLS programs at 5 affiliated universities.  Students spend approximately 9 months in our clinical laboratory training. Completion of coursework here at HCMC earns college credit at their home university.  The Phlebotomy Technician program accepts students for a 12-week certificate program including both lecture and practical training. Enrollment at an affiliated university or school is not needed for the Phlebotomy Technician program."
|-
  | style="font-weight: bold; padding-left:10px;"|Houston Methodist Hospital
  | style="background-color:white; padding-left:10px;"|U.S. - TX (Houston)
  | style="background-color:white; padding-left:10px;"|[https://www.houstonmethodist.org/education/allied-health/medical-laboratory-science-education-program/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"Houston Methodist Hospital Medical Laboratory Science Program is a 12-month professional course of study, which is fully accredited by the National Accrediting Agency for Clinical Laboratory Sciences (NAACLS). Upon successful completion of this course of study, you will qualify for the examination and certification by the board of certification of the American Society of Clinical Pathology (ASCP)."
|-
  | style="font-weight: bold; padding-left:10px;"|Indiana University Health Methodist Hospital
  | style="background-color:white; padding-left:10px;"|U.S. - IN (Indianapolis)
  | style="background-color:white; padding-left:10px;"|[https://iuhealth.org/professional-education/health-sciences-education/clinical-laboratory-scientist-medical-technologist Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"After meeting the prerequisites, students apply for a full-time internship at Indiana University Health Methodist Hospital Medical Laboratory Science Program. The program runs for 11 months, full-time days and is divided into two phases."
|-
  | style="font-weight: bold; padding-left:10px;"|Inova Fairfax Hospital
  | style="background-color:white; padding-left:10px;"|U.S. - VA (Falls Church)
  | style="background-color:white; padding-left:10px;"|[https://www.inova.org/education/student-educational-opportunities/medical-laboratory-science-program Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"The Inova Fairfax Hospital Medical Laboratory Science program is a highly competitive and rigorous 11-month-long program consisting of over 1,700 clock hours of instruction. The program is intended to qualify its graduates to take the National Board of Certification examination given by the American Society for Clinical Pathology in pursuit of the MLS (ASCP) certification. We enroll 6-8 students each year."
|-
  | style="font-weight: bold; padding-left:10px;"|Jersey Shore University Medical Center
  | style="background-color:white; padding-left:10px;"|U.S. - NJ (Neptune)
  | style="background-color:white; padding-left:10px;"|[https://www.hackensackmeridianhealth.org/en/Healthcare-Professionals/JSUMC/florence-m-cook-school-of-medical-laboratory-science Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"The Medical Laboratory Science (MLS) program at Florence M. Cook School is a full-time eleven-month hospital-based program. It is fully accredited by the National Accreditation Agency for Clinical Laboratory Science (NAACLS)."
|-
  | style="font-weight: bold; padding-left:10px;"|Lexington Medical Center
  | style="background-color:white; padding-left:10px;"|U.S. - SC (West Columbia)
  | style="background-color:white; padding-left:10px;"|[https://www.lexmed.com/careers/advanced-training/school-of-medical-laboratory-science Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"The Program is 12-month in length and begins and ends each August. No more than four students are enrolled at a time, allowing for an extremely low student-to-teacher ratio that maximizes learning."
|-
  | style="font-weight: bold; padding-left:10px;"|Mercy Health - St. Vincent Medical Center
  | style="background-color:white; padding-left:10px;"|U.S. - OH (Toledo)
  | style="background-color:white; padding-left:10px;"|[https://www.mercy.com/about-us/careers/graduate-medical-education/locations/toledo/clinical-lab-science-program-at-st-vincent-medical-center Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"The one-year program begins in July. You will spend approximately 40 hours a week, eight hours a day, dividing your time between the classroom and the laboratory. Instruction includes technical and clinical aspects of laboratory analysis with clinical correlation, and theory and concepts in the clinical laboratory and behavior sciences."
|-
  | style="font-weight: bold; padding-left:10px;"|Mercy Hospital St. Louis
  | style="background-color:white; padding-left:10px;"|U.S. - MO (St. Louis)
  | style="background-color:white; padding-left:10px;"|[https://www.mercy.net/healthcare-education/career/scls/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"The fifty-one week program provides a structured educational experience which includes lectures and clinical laboratory rotations ... The CLS program awards a certificate upon successful completion of the year. The certificate plus an appropriate baccalaureate degree allows the student to sit for a national certification examination."
|-
  | style="font-weight: bold; padding-left:10px;"|Monmouth Medical Center
  | style="background-color:white; padding-left:10px;"|U.S. - NJ (West Orange)
  | style="background-color:white; padding-left:10px;"|[https://www.rwjbh.org/for-healthcare-professionals/medical-education/monmouth-medical-center/john-a-mihok-school-of-medical-laboratory-scienc/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"The John A. Mihok Medical Laboratory Science Program (MLS) at Monmouth Medical Center (MMC) is a 12-month comprehensive experiential learning experience. The program starts each year during the last week of August and includes six (6) months of didactic (classroom) instruction and practical exercises in student lab followed by six (6) months of clinical laboratory rotations."
|-
  | style="font-weight: bold; padding-left:10px;"|Myron E. Rubnitz, M.D. School of Medical Laboratory Science
  | style="background-color:white; padding-left:10px;"|U.S. - IL (Hines)
  | style="background-color:white; padding-left:10px;"|[https://www.va.gov/hines-health-care/work-with-us/internships-and-fellowships/myron-e-rubnitz-md-school-of-medical-laboratory-science/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"...consists of 11 months of clinical education beginning the first week of August. All sciences courses at Hines have a didactic and a practical component; this enables the student to learn the theory of procedures, gain experience in performing those procedures and make clinical correlations from the laboratory data generated."
|-
  | style="font-weight: bold; padding-left:10px;"|Nebraska Methodist Hospital
  | style="background-color:white; padding-left:10px;"|U.S. - NE (Omaha)
  | style="background-color:white; padding-left:10px;"|[https://pathologycenter.bestcare.org/medical-laboratory-science-program Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|An 11-month internship that runs from June to early May. "The program accepts applications from August through October 15 for the next academic year's class."
|-
  | style="font-weight: bold; padding-left:10px;"|NewYork-Presbyterian Brooklyn Methodist Hospital
  | style="background-color:white; padding-left:10px;"|U.S. - NY (Brooklyn)
  | style="background-color:white; padding-left:10px;"|[https://www.nypcls.org/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"The program involves a full-time, one-year commitment where students concurrently engage in both didactic and clinical educational experiences."
|-
  | style="font-weight: bold; padding-left:10px;"|Northern Light Eastern Maine Medical Center
  | style="background-color:white; padding-left:10px;"|U.S. - ME (Bangor)
  | style="background-color:white; padding-left:10px;"|[https://www.northernlighthealth.org/School-of-Medical-Laboratory-Science Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"The 11-month training program results in a certificate in medical laboratory science from Northern Light Eastern Maine Medical Center while fulfilling requirements for the bachelor of science in Medical Laboratory Science from the University of Maine. Upon successful program completion, students are eligible to sit for the American Society of Clinical Pathology (ASCP) board of certification (BOC) examination."
|-
  | style="font-weight: bold; padding-left:10px;"|Our Lady of Fatima Hospital
  | style="background-color:white; padding-left:10px;"|U.S. - RI (Providence)
  | style="background-color:white; padding-left:10px;"|[https://www.chartercare.org/services/school-of-medical-technology/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"The Our Lady of Fatima School of Medical Technology program is a twelve-month internship that begins in June and ends the following June. Our Lady of Fatima accepts, on average, seven students into the program ... Upon completion of the internship, students graduate with a certificate and are eligible to sit for the board of certification given by the American Society of Clinical Pathology (ASCP)."
|-
  | style="font-weight: bold; padding-left:10px;"|Parkview Health Laboratories
  | style="background-color:white; padding-left:10px;"|U.S. - IN (Fort Wayne)
  | style="background-color:white; padding-left:10px;"|[https://www.parkview.com/careers/medical-laboratory-science-program/medical-laboratory-science-program Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"Students must pass a final exam to successfully complete the Parkview Medical Laboratory Science Program. Upon completion, students receive a graduation certificate. They are then eligible to pursue certifications offered by the Board of Certification of the American Society for Clinical Pathology."
|-
  | style="font-weight: bold; padding-left:10px;"|Parkview Medical Center
  | style="background-color:white; padding-left:10px;"|U.S. - CO (Pueblo)
  | style="background-color:white; padding-left:10px;"|[https://www.parkview.com/careers/medical-laboratory-science-program/about-our-program Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"Classes begin each year in July. The program is 11 months in length."
|-
  | style="font-weight: bold; padding-left:10px;"|Reading Hospital
  | style="background-color:white; padding-left:10px;"|U.S. - PA (Reading)
  | style="background-color:white; padding-left:10px;"|[https://www.readinghealth.org/education-and-research/school-of-laboratory-sciences/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"This 12-month program is open to students looking to complete their undergraduate medical laboratory science degree in a clinical setting (3+1 option), or take a post-baccalaureate year to gain experience (4+1 option)."
|-
  | style="font-weight: bold; padding-left:10px;"|Sanford USD Medical Center
  | style="background-color:white; padding-left:10px;"|U.S. - SD (Sioux Falls)
  | style="background-color:white; padding-left:10px;"|[https://www.sanfordhealth.org/student-programs/medical-laboratory-science-program Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"The MLS program consists of 48 weeks of combined didactic classroom lecture and real life clinical laboratory training in our state of the art medical laboratory. The student to instructor ratio in the classroom is ten to one. The clinical training in the laboratory is typically one to one with an instructing staff member or instructor. A certificate of completion is awarded to graduating students ... Applications are accepted Aug. 1 to Oct. 1 for the programs starting the following summer."
|-
  | style="font-weight: bold; padding-left:10px;"|Santa Barbara Cottage Hospital
  | style="background-color:white; padding-left:10px;"|U.S. - CA (Santa Barbara)
  | style="background-color:white; padding-left:10px;"|[https://www.cottagehealth.org/medical-professionals/clinical-laboratory-science-training-program/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"Training Period: 12 months; Training Begins: September (Fall), February/March (Spring); Class Size: Up to 3 students per start date"
|-
  | style="font-weight: bold; padding-left:10px;"|School of Medical Laboratory Science at Pennsylvania Hospital
  | style="background-color:white; padding-left:10px;"|U.S. - PA (Philadelphia)
  | style="background-color:white; padding-left:10px;"|[https://www.uphs.upenn.edu/pahedu/medical-laboratory-science/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"Students are given both practical and theoretical training in various sections of the clinical laboratory. The practicum is a 11-month rotating program based on a 40-hour week, beginning in late August (Fall cohort) or January (Spring cohort). The program devotes six hours per week to formal lectures."
|-
  | style="font-weight: bold; padding-left:10px;"|Sentara RMH Medical Center
  | style="background-color:white; padding-left:10px;"|U.S. - VA (Harrisonburg)
  | style="background-color:white; padding-left:10px;"|[https://www.sentara.com/hospitalslocations/locations/school-of-medical-laboratory-science.aspx Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"The School of Medical Laboratory Science admits up to twelve students in January and June.  The program includes six months of lecture and student labs in Harrisonburg, VA., followed by six months of rotation through all departments in the clinical laboratory.  Clinical rotation sites include Sentara RMH Medical Center, Sentara Halifax Regional Hospital, Sentara Martha Jefferson Hospital, Sentara Norfolk General Hospital, and Sentara Northern Virginia Medical Center."
|-
  | style="font-weight: bold; padding-left:10px;"|St. Christopher's Hospital for Children
  | style="background-color:white; padding-left:10px;"|U.S. - PA (Philadelphia)
  | style="background-color:white; padding-left:10px;"|[https://towerhealth.org/education-st-christophers-hospital-children/medical-laboratory-science Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"To fulfill their clinical and academic requirements in 10 months, students spend two months in didactic instruction with the remainder of time spent as follows: Mondays in the classroom and Tuesday-Fridays in their medical laboratory rotations. The academic year begins in late August and typically ends in late June."
|-
  | style="font-weight: bold; padding-left:10px;"|St. Elizabeth Healthcare
  | style="background-color:white; padding-left:10px;"|U.S. - KY (Edgewood)
  | style="background-color:white; padding-left:10px;"|[https://www.stelizabeth.com/care/st-elizabeth-school-of-medical-laboratory-science/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"St. Elizabeth School of Medical Laboratory Science has been in operation since the 1950’s. Curriculum at St. Elizabeth Healthcare Medical Laboratory Science Program consists of an 11-month program of both didactic and supervised clinical training"
|-
  | style="font-weight: bold; padding-left:10px;"|St. Luke's Hospital
  | style="background-color:white; padding-left:10px;"|U.S. - MO (Kansas City)
  | style="background-color:white; padding-left:10px;"|[https://www.saintlukeskc.org/medical-laboratory-science-program Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"As a Medical Lab Science student, you’ll be trained only in Saint Luke’s Health System laboratories, which allows us to closely monitor and control the quality of your education. In addition, our regional reference laboratory will expose you to a range of laboratory testing that is unmatched in the area. Rotations also include three weeks of molecular diagnostics instruction in our Roche Molecular Center of Excellence laboratory, the only one in Kansas and Missouri."
|-
  | style="font-weight: bold; padding-left:10px;"|UCLA Health
  | style="background-color:white; padding-left:10px;"|U.S. - CA (Los Angeles)
  | style="background-color:white; padding-left:10px;"|[https://www.uclahealth.org/pathology/body.cfm?id=64&fr=true Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"The UCLA CLS Program ONLY accepts students through the California State University, Dominguez Hills, College of Professional Studies, School of Health and Human Services, Clinical Sciences Major,  Medical Technology Program Option. "
|-
  | style="font-weight: bold; padding-left:10px;"|United Regional Health Care System
  | style="background-color:white; padding-left:10px;"|U.S. - TX (Wichita Falls)
  | style="background-color:white; padding-left:10px;"|[https://www.unitedregional.org/united-regional-careers/become-a-medical-laboratory-scientist-mls/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"United Regional's School of MLS is a 52-week program and must be completed in order to be eligible for certification examinations or employment as a Medical Laboratory Scientist."
|-
  | style="font-weight: bold; padding-left:10px;"|UnityPoint Health - Cedar Rapids
  | style="background-color:white; padding-left:10px;"|U.S. - IA (Cedar Rapids)
  | style="background-color:white; padding-left:10px;"|[https://www.unitypoint.org/cedarrapids/school-of-medical-laboratory-science.aspx Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"The program typically starts mid-August and is a 35 week program. Classes meeting Monday-Friday and the hours are typically 0700-1430. There are some rotations where it is required to come in before 0700 or stay until 1530. Mornings are spent in the clinical laboratory rotation with lecture in the afternoon."
|-
  | style="font-weight: bold; padding-left:10px;"|University of California Irvine Medical Center
  | style="background-color:white; padding-left:10px;"|U.S. - CA (Irvine)
  | style="background-color:white; padding-left:10px;"|[https://pathology.uci.edu/clinical-laboratory-scientist-program.asp Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"The CLS Training Program provides a full year of didactic and clinical instruction. The curriculum includes intensive bench training, formal and informal lectures, and case studies. Students receive more than 200 hours of formal lectures covering the various disciplines of clinical laboratory science."
|-
  | style="font-weight: bold; padding-left:10px;"|University of Nebraska Medical Center
  | style="background-color:white; padding-left:10px;"|U.S. - NE (Omaha)
  | style="background-color:white; padding-left:10px;"|[https://www.unmc.edu/alliedhealth/education/mls/index.html Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"The University of Nebraska Medical Center offers a Bachelor of Science degree in Medical Laboratory Science (MLS). The MLS Program is well established and combines a strong curriculum with a clinical component that prepares individuals to sit for MLS/MT national certification exams."
|-
  | style="font-weight: bold; padding-left:10px;"|The Valley Hospital
  | style="background-color:white; padding-left:10px;"|U.S. - NJ (Ridgewood)
  | style="background-color:white; padding-left:10px;"|[https://www.valleyhealth.com/services/laboratory-services/medical-laboratory-science-program Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"... the student may then apply for admission to the professional phase of the program, which is a 11-month internship in a clinical setting. Individuals who have completed a baccalaureate degree in a scientific discipline can also apply to the professional program with completion of prerequisite coursework."
|-
  | style="font-weight: bold; padding-left:10px;"|UPMC Chautauqua
  | style="background-color:white; padding-left:10px;"|U.S. - NY (Jamestown)
  | style="background-color:white; padding-left:10px;"|[https://chautauquamlsprogram.com/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"The UPMC Chautauqua Medical Laboratory Science Program is an accredited, 45-week, program offering intensive study and clinical experience in medical laboratory science as the final year of a Bachelor’s degree."
|- 
  | style="font-weight: bold; padding-left:10px;"|Vanderbilt University Medical Center
  | style="background-color:white; padding-left:10px;"|U.S. - TN (Nashville)
  | style="background-color:white; padding-left:10px;"|[https://www.vumc.org/med-tech/welcome Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"Upon satisfactory completion of the training program, a certificate of completion is awarded to the student. The course of study during the clinical year may be credited towards a baccalaureate degree for 3+1 students where an affiliation between the student's college or university and the Medical Center exists."
|-
  | style="font-weight: bold; padding-left:10px;"|WellSpan York Hospital
  | style="background-color:white; padding-left:10px;"|U.S. - PA (York)
  | style="background-color:white; padding-left:10px;"|[https://www.wellspan.org/medical-professionals/education-programs/wellspan-health-medical-laboratory-science-program/ Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"... a 12-month program for college students sponsored by WellSpan York Hospital. The program typically serves as a student's senior year of college (3+1 option), but applicants with a B.S. degree (4+1) who meet the entrance requirements will be considered as well."
|-
  | style="font-weight: bold; padding-left:10px;"|UPMC Williamsport
  | style="background-color:white; padding-left:10px;"|U.S. - PA (Williamsport)
  | style="background-color:white; padding-left:10px;"|[https://www.upmc.com/campaigns/north-central-pa/medical-professionals/clinical-laboratory-science-program Medical Laboratory Science Program]
  | style="background-color:white; padding-left:10px;"|"The Medical Laboratory Science Program is a 12-month educational program designed to be completed as the fourth or fifth year in a baccalaureate degree program ... Upon successful completion of the program, students receive a baccalaureate degree from their affiliating college/university and a Certificate of Graduation from the hospital."
|-
|}
|}


====Continuing education====
First, what are the laboratory's goals? Does the third-party laboratory owner envision a small investment, taking in a slow but steady flow of formulation requests, or  do they envision expansive growth, expanding into multiple food and beverage testing domains? If the lab is starting small but is confidently expecting to grow, technological investments early on may want to take into account future technologies that may shape data management and security processes. Second, what kind of work will the lab be doing, and what regulatory responsibilities will guide hardware and software investment at the lab? If your lab will be conducting extractable and leachable testing, you'll be considering [[chromatography]] and [[spectroscopy]] instruments, as well as requirements for retaining analytical results for regulators. The Laboratory Accreditation for Analyses of Foods (LAAF)-accredited testing lab will likely have many more instruments to cover all its testing needs, and its data management system will likely need to be able to interface to U.S. Food and Drug Administration systems, or at a minimum report in their specific format. Third, your laboratory's budget is always important. Does the budget allow for on-site hardware and software systems, with the personnel to maintain them? Is it easier to pay up-front or find a vendor willing to work with you on leasing or rental terms? (We talk about other cost considerations a bit later.)
[https://www.aama-ntl.org/continuing-education AAMA's various online courses]: The American Association of Medical Assistants offers courses and continuing education opportunities.


[https://labucate.org/coursesASCLS ASCLS Labucate]: The American Society for Clinical Laboratory Science (ASCLS) offers "convenient, high-quality, and affordable continuing education for laboratory professionals."
Finally, will the lab have someone on-site or on-call to resolve technology issues, including set-up and maintenance of software systems? If your lab will have little in the way of available tech help locally, you'll want to consider the distribution model you want to use for any installed software, i.e., you may want to consider [[software as a service]] (SaaS). An increasing number of software services are hosted using [[cloud computing]], which when done well is an increasingly reliable option.<ref name="IzrailevskyCloud18">{{cite journal |title=Cloud Reliability |journal=IEEE Cloud Computing |author=Izrailevsky, Y.; Bell, C. |volume=5 |issue=3 |pages=39–44 |year=2018 |doi=10.1109/MCC.2018.032591615}}</ref> Having someone else host the software for you typically means the hosting provider will carry a non-trivial portion of responsibility for technology maintenance and security. Speaking of security, you'll also want to consider the [[cybersecurity]] (addressed later) of not only your software solution but also your overall laboratory operations. Does your organization have a cybersecurity plan already in place, or has the decision to make one been postponed? What extra investment is required to ensure your sensitive data is secure? Remember that how you rank your cybersecurity preparedness and implement a cybersecurity plan will also guide your technology investment decisions.<ref name="DouglasComp20">{{cite web |title=[[LII:Comprehensive Guide to Developing and Implementing a Cybersecurity Plan|''Comprehensive Guide to Developing and Implementing a Cybersecurity Plan'']] |author=Douglas, S.E. |work=LIMSwiki |date=July 2020 |accessdate=07 December 2022}}</ref>


[https://www.labce.com/mls_mt_mlt_lab_continuing_education.aspx LabCE's various online classes]: LabCE offers more than 90 online clinical laboratory continuing education courses "for lab professionals, including medical laboratory technologists (MT), laboratory technicians (MLT), and students." Many of them are PACE-approved for continuing education credits.
'''3.1.1.1 Laboratory informatics options'''


'''Other courses'''
Keeping the above in mind, what are the common software solutions used within a food and beverage laboratory? One of the more commonly discussed options is the LIMS, a laboratory informatics solution designed to assist laboratories with managing testing workflows, data, and other aspects of their operations.


The Centers for Medicare and Medicaid Services has [https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/CME_Courses_for_Laboratory_Directors_of_Moderate_Complexity_Laboratories a listing of CME courses] that help aspiring laboratory directors of moderate complexity laboratories meet CLIA guidelines.
The use of LIMS in food production facilities and labs is not a new concept.<ref>{{Cite journal |last=Çağındı |first=Özlem |last2=Ötleş |first2=Semih |date=2004-12 |title=Importance of laboratory information management systems (LIMS) software for food processing factories |journal=Journal of Food Engineering |language=en |volume=65 |issue=4 |pages=565–568 |doi=10.1016/j.jfoodeng.2004.02.021}}</ref> However, little information can be found as to the percentage of today's food and beverage laboratories using a LIMS in their workflow. Several surveys from 2020, however, hint that LIMS are important to these types of labs. A survey of 135 professionals—nine percent of them from the food and beverage industry—from laboratory consultancy Astrix Technology found that more than 77 percent of respondents had at least one LIMS implemented in their organization.<ref name="Astrix2020LIMS">{{cite web |url=https://astrixinc.com/wp-content/uploads/2021/03/Astrix-2020-LIMS-Market-Research-Report.pdf |format=PDF |title=Astrix 2020 LIMS Market Research Survey Report |publisher=Astrix Technology, LLC |date=March 2021 |accessdate=07 December 2022}}</ref> A separate survey from ''Lab Manager'' about analytical instrument use among readers found that more than 16 percent of them were using instruments for food and beverage analysis.<ref name="Crawford-BrownResults20">{{cite web |url=https://www.labmanager.com/surveys/results-from-the-lab-manager-analytical-instrument-survey-22109 |title=Results from the Lab Manager Analytical Instrument Survey |work=Lab Manager |author=Crawford-Brown, C. |date=25 March 2020 |accessdate=07 December 2022}}</ref> Given the importance of integrating instrumentation and produced data in a food and beverage production and testing environment<ref name="SmithInteg19">{{cite web |url=https://foodsafetytech.com/feature_article/integrated-informatics-optimizing-food-quality-and-safety-by-building-regulatory-compliance-into-the-supply-chain/ |title=Integrated Informatics: Optimizing Food Quality and Safety by Building Regulatory Compliance into the Supply Chain |author=Smith, K. |work=Food Safety Tech |date=02 July 2019 |accessdate=07 December 2022}}</ref><ref name="ApteIsYour20">{{cite web |url=https://foodsafetytech.com/column/is-your-food-testing-lab-prepping-for-an-iso-iec-17025-audit/ |title=Is Your Food Testing Lab Prepping for an ISO/IEC 17025 Audit? |author=Apte, A. |work=Food Safety Tech |date=20 October 2020 |accessdate=07 December 2022}}</ref><ref name="SiemensProcess22">{{cite web |url=https://assets.new.siemens.com/siemens/assets/api/uuid:ca5438d3-5b52-4b41-aae0-aaaa3685484e/pibr-00021-0820-food-bev-portrait.pdf |format=PDF |title=Food & Beverage Process Automation and Instrumentation |publisher=Siemens Industry, Inc |date=2022 |accessdate=07 December 2022}}</ref>, a LIMS or other informatics solution appears to be increasingly critical to eliminating manual processes, improving sample management, increasing productivity, and improving regulatory conformance.<ref name="Astrix2020LIMS" /> This, of course, lends to the food and beverage lab's focus on safety, quality, and compliance.


===List of staffing agencies===
A LIMS can improve laboratory workflows and workloads while enhancing safety, quality, and compliance in a number of ways. A fragmented mix of paper-based and electronic information sources can be a detriment to the traceability of or rapid accessibility to ingredients, additives, quality control samples, standard operating procedures (SOPs), environmental monitoring data, chain of custody data, and other vital aspects of food and beverage production. A well-implemented LIMS can reduce the silos of information and data, while at the same time make that information and data more secure and readily accessible. Given the regulatory demands for providing rapid proof of traceable product movement and relevant quality control data, the LIMS acts as the central integrator and audit trail for that information.<ref name="SmithInteg19" /><ref name="McDermottHowDig18">{{cite web |url=https://foodsafetytech.com/column/how-digital-solutions-support-supply-chain-transparency-and-traceability/ |title=How Digital Solutions Support Supply Chain Transparency and Traceability |author=McDermott, P. |work=Food Safety Tech |date=31 July 2018 |accessdate=07 December 2022}}</ref><ref name="EvansTheDig19">{{cite web |url=https://foodsafetytech.com/feature_article/the-digital-transformation-of-global-food-security/ |title=The Digital Transformation of Global Food Security |author=Evans, K. |work=Food Safety Tech |date=15 November 2019 |accessdate=07 December 2022}}</ref> Because the LIMS improves traceability—including through its automated interfaces with instruments and other data systems—real-time monitoring of supply chain issues, quality control data, instrument use, and more is further enabled, particularly when paired with configurable dashboards and alert mechanisms. By extension, food and beverage producers can more rapidly act on insights gained from those real-time dashboards.<ref name="SmithInteg19" /> This is also means that the food and beverage testing lab can react more rapidly to issues that compromise compliance with certification to the [[ISO 17025]] standard or Food and Drug Administration (FDA) [[LII:FDA Food Safety Modernization Act Final Rule on Laboratory Accreditation for Analyses of Foods: Considerations for Labs and Informatics Vendors|Food Safety Modernization Act]] (FSMA) requirements.<ref name="ApteIsYour20" /><ref name="PaszkoTrace15">{{cite web |url=https://foodsafetytech.com/feature_article/traceability-leveraging-automation-to-satisfy-fsma-requirements/ |title=Traceability: Leveraging Automation to Satisfy FSMA Requirements |author=Paszko, C. |work=Food Safety Tech |date=19 August 2015 |accessdate=07 December 2022}}</ref><ref name="PaszkoHow15">{{cite web |url=https://foodsafetytech.com/feature_article/how-lims-facilitates-iso-17025-certification-in-food-testing-labs/ |title=How LIMS Facilitates ISO 17025 Certification in Food Testing Labs |author=Paszko, C. |work=Food Safety Tech |date=26 October 2015 |accessdate=07 December 2022}}</ref><ref name="DanielsUsing17">{{cite web |url=https://foodsafetytech.com/column/using-lims-get-shape-fdas-visit/ |title=Using LIMS to Get In Shape for FDA’s Visit |author=Daniels, T. |work=Food Safety Tech |date=22 March 2017 |accessdate=07 December 2022}}</ref> Finally, many modern LIMS tailored to the food and beverage industry come pre-configured out of the box with analytical and quality control workflow support tools that can be further optimized to a lab's unique workflow.<ref name="IngallsHowAdv20">{{cite web |url=https://foodsafetytech.com/feature_article/how-advanced-lims-brings-control-consistency-and-compliance-to-food-safety/ |title=How Advanced LIMS Brings Control, Consistency and Compliance to Food Safety |author=Ingalls, E. |work=Food Safety Tech |date=06 August 2020 |accessdate=07 December 2022}}</ref>
The following are staffing agencies that focus at least some of their energy towards finding and placing laboratory personnel and management, including medical technologists, medical laboratory technicians, cytotechnologists, histotechnologists, and laboratory directors.


====National (U.S.) and global====
However, the LIMS is not the sole information management solution for food and beverage producers and laboratories. Software-based information management solutions are being marketed to food and beverage labs in other ways. Some vendors have taken to marketing the somewhat related [[laboratory execution system]] (LES), which tends to focus more on laboratory test method execution at the process level while integrating other R&D functionalities found in, for example, [[electronic laboratory notebook]]s (ELNs).<ref name="iVentionLES">{{cite web |url=https://hs.iles.cloud/en/food-and-beverages-lab-execution |title=iLES Food & Beverages Lab Execution |publisher=iVention BV |accessdate=07 December 2022}}</ref><ref name="LVSHowLIMS20">{{cite web |url=https://www.news-medical.net/whitepaper/20200416/How-LIMS-can-Improve-your-Food-and-Beverage-Testing-Lab.aspx |title=How LIMS can Improve your Food and Beverage Testing Lab |author=LabVantage Solutions |work=News Medical |date=16 April 2020 |accessdate=07 December 2022}}</ref> Other vendors have moved away from the "LIMS" and "LES" moniker completely, referring to their software as simply "food safety software." These offerings appear to focus on helping a producer do more than manage laboratory testing output by addressing other organizational needs such as developing regulatory-driven safety plans, generating schedules for environmental testing, improving communication and compliance, improving reaction time to non-conformances, improving audit readiness and reporting, ensuring greater compliance, and identifying trends across the entire enterprise.<ref name="CorviumWhatIs19">{{cite web |url=https://corvium.com/what-is-a-food-intelligence-platform-lims-vs-food-safety-software/ |title=What Is a Food Intelligence Platform? LIMS vs. Food Safety Software |publisher= |date=09 May 2019 |accessdate=07 December 2022}}</ref><ref name="FLQSafety">{{cite web |url=https://www.foodlogiq.com/solutions/safety-and-quality/ |title=Safety & Quality Management |publisher=FoodLogiQ |accessdate=07 December 2022}}</ref><ref name="SCFoodSafety">{{cite web |url=https://safetychain.com/food-safety-software/ |title=Food Safety Software |publisher=SafetyChain Software, Inc |accessdate=07 December 2022}}</ref><ref name="F3AgTechBest">{{cite web |url=https://agtech.folio3.com/food-safety-software/ |title=Best Food Safety Software For Quality Management Of Food |publisher=Folio3 Software, Inc |accessdate=07 December 2022}}</ref><ref name="FDAIPower">{{cite web |url=https://www.fooddocs.com/ |title=FoodDocs: AI-Powered Food Safety System with a HACCP builder |publisher=FoodDocs |accessdate=07 December 2022}}</ref> In comparison, some LIMS may or may not address these issues; this functionality will be discussed further in the next subsection.
* [http://ahcstaff.com/job-seekers/allied/ Accountable Healthcare Staffing]
* [http://www.aerotek.com/clinical/clinical-jobs.aspx Aerotek]
* [http://www.allmedstaffing.com/healthcare-staffing.html All Medical Personnel]
* [http://www.allswell.net/Job-Seekers/default.aspx ALL's WELL]
* [http://www.amnhealthcare.com/allied_staffing_services/ AMN Healthcare]
* [http://www.aureusmedical.com/medical-laboratory/clinical-lab-scientist-cls-jobs.aspx Aureus Medical Group]
* [http://www.clubstaffing.com/allied-disciplines/ Club Staffing]
* [http://www.comphealth.com/job-opportunities CompHealth]
* [http://www.fusionmedstaff.com/jobs/ Fusion Medical Staffing]
* [http://labcareer.com/ HealthCare Connections, Inc.]
* [http://www.insourcesolutions.com/laboratory-jobs/ Insource]
* [http://joulescientific.com/default.aspx Joule Scientific Staffing Solutions]
* [http://www.kellyglobal.net/eprise/main/cms/content/us/ksr/en/pages/specialty_gen_lab.html Kelly Scientific]
* [http://www.labsupport.com/ Lab Support]
* [http://www.lighthouserecruiting.com/ Lighthouse Recruiting]
* [http://www.maximstaffing.com/candidates/alliedHealth.aspx Maxim Staffing Solutions]
* [http://www.medtravelers.com/allied-healthcare-disciplines/medical-laboratory-technician-jobs/ Med Travellers]
* [http://www.medstaffservices.com/ Medical Staffing Services]
* [http://info.milleniamedical.com/clinical-lab-division Millenia Medical Staffing]
* [http://www.scientificrecruitment.com/ Scientific Recruitment Agency]
* [http://www.soliant.com/laboratory/ Soliant]
* [http://www.stmarksworld.com/pages/allied-health-staffing/ St. Mark's World]
* [http://www.staffpointe.com/ StaffPointe]
* [https://www.travelforce.com/medical-laboratory-jobs/ Travel Force Staffing]
* [http://www.travelmaxallied.com/ TravelMax Allied]
* [http://www.uniforce.com/ClinicalSupport.asp Uniforce Staffing Solutions]


====Regional (U.S.)====
====3.1.2 Features and functions====
Given the above, it's clear LIMS adoption and use is important to the continued success of food and beverage labs. However, in most cases, a generic LIMS won't do; it's imperative the lab find a solution that meets all or most of its workflow requirements. This more often than not requires a configurable solution that enables trained users to quickly make the changes they need, if those changes make sense within the overall data structure of the LIMS. It also requires a solution that has been thoughtfully developed and continues to be carefully maintained to address the ever-shifting standard- and regulation-based requirements of the food and beverage laboratory. The following examines both the base features and specialty requirements of a food and beverage LIMS.


* [http://www.accessstaffing.com/Specialties/Scientific Access Staffing] (New York)
'''3.1.2.1 Base features'''
* [http://flmedstaffing.com/ Florida Medical Staffing] (Florida)
* [http://hpmstaffing.com/ Health Professional Medical Staffing] (California)
* [http://www.healthcaretalent.net/career-profiles/ HealthCare Talent] (California)
* [http://www.labprosinc.com/ Lab Pros] (Massachusetts)
* [http://labstaff.com/ Laboratory Staffing, Inc.] (Minnesota)
* [http://www.labtechkc.com/ Labtech Specialty Staffing] (Kansas / Missouri)
* [http://www.mitchellmartin.com Mitchell Martin] (New York)
* [http://www.nuwestgroup.com/about/labtemps/ NuWest] (Washington)
* [http://www.stovermedicalservices.com/?page_id=20 Stover Medical Support Services] (Missouri / Illinois)
* [http://temporarylabservices.com/801.html Temporary Lab Services] (Virginia)


==References==
What follows is a list of system functionality important to most any food and beverage laboratory, with a majority of that functionality found in many vendor software solutions.<ref name="SmithInteg19" /><ref name="ApteIsYour20" /><ref name="McDermottHowDig18" /><ref name="EvansTheDig19" /><ref name="IngallsHowAdv20" /><ref name="iVentionLES" /><ref name="StarlimsFood22">{{cite web |url=https://www.starlims.com/wp-content/uploads/food-and-bev-lims-spec-document.pdf |format=PDF |title=STARLIMS Food and Beverage Industry LIMS Specification Document |publisher=STARLIMS Corporation |date=November 2021 |accessdate=07 December 2022}}</ref>
<references />
 
'''''Test, sample and result management'''''
 
*Sample log-in and management, with support for unique IDs
*Sample batching
*[[Barcode]] and RFID support
*End-to-end sample and inventory tracking
*Pre-defined and configurable industry-specific test and method management, including for bacteria (i.e., microbiology), heavy metals (i.e., chemistry), drug residues (i.e., pharmaceutical chemistry), and other substances
*Pre-defined and configurable industry-specific workflows
*Configurable screens and data fields
*Specification management
*Test, sampling, instrument, etc. scheduling and assignment
*Test requesting
*Data import and export
*Robust query tools
*Analytical tools, including [[data visualization]], statistical analysis, and [[data mining]] tools
*Document and image management
*Version control
*Project management
*Method and protocol management
*Investigation management
*Facility and sampling site management
*Storage management and monitoring
 
'''''Quality, security, and compliance'''''
 
*[[Quality assurance]] / [[quality control]] mechanisms
*Mechanisms for compliance with ISO 17025 and HACCP, including support for critical control point (CCP) specifications and limits
*Result, method, protocol, batch, and material validation, review, and release
*Data validation
*Trend and control charting for statistical analysis and measurement of uncertainty
*User qualification, performance, and training management
*[[Audit trail]]s and [[chain of custody]] support
*Configurable and granular role-based security
*Configurable system access and use (i.e., authentication requirements, account usage rules, account locking, etc.)
*[[Electronic signature]] support
*Data [[encryption]] and secure communication protocols
*Archiving and [[Data retention|retention]] of data and information
*Configurable data [[backup]]s
*Status updates and alerts
*Environmental monitoring support
*Incident and non-conformance notification, tracking, and management
 
'''''Operations management and reporting'''''
 
*Configurable dashboards for monitoring, by product, process, facility, etc.
*Customizable rich-text reporting, with multiple supported output formats
*Custom and industry-specific reporting, including certificates of analysis (CoAs)
*Industry-compliant labeling
*Email integration
*Instrument interfacing and data management
*Third-party software interfacing (e.g., LES, scientific data management system [SDMS], other database)
*Data import, export, and archiving
*Instrument calibration and maintenance tracking
*Inventory and material management
*Supplier/vendor/customer management
*Integrated (or online) system help
 
'''3.1.2.2 Specialty features'''
 
As noted previously, some software vendors are addressing food and beverage processor needs beyond the basic laboratory through their food safety software. A standard LIMS tailored for the food and beverage industry may already contribute to some of these wider organizational functions, as well as more advanced laboratory workflow requirements, but many may not, or may vary in what additional functionality they provide. In that regard, a food and beverage LIMS vendor may also include specialized functionality that helps the food and beverage producer and its laboratory<ref name="iVentionLES" /><ref name="CorviumWhatIs19" /><ref name="FLQSafety" /><ref name="SCFoodSafety" /><ref name="FDAIPower" /><ref name="StarlimsFood22" /><ref name="Douglas">{{Cite web |last=Douglas, S.E. |date=May 2022 |title=17. Production management |work=LIMSpec 2022 R2 |url=https://www.limswiki.org/index.php?title=LII:LIMSpec/Specialty_Laboratory_Functions#17._Production_management |publisher=LIMSwiki.org |accessdate=07 December 2022}}</ref><ref>{{Cite journal |last=Chen |first=Xinyu |last2=Voigt |first2=Tobias |date=2020-08 |title=Implementation of the Manufacturing Execution System in the food and beverage industry |journal=Journal of Food Engineering |language=en |volume=278 |pages=109932 |doi=10.1016/j.jfoodeng.2020.109932}}</ref><ref>{{Cite book |date=2011 |editor-last=Kilcast |editor-first=David |editor2-last=Subramaniam |editor2-first=Persis |title=Food and beverage stability and shelf life |url=https://www.worldcat.org/title/mediawiki/oclc/838321011 |series=Woodhead Publishing series in food science, technology and nutrition |publisher=WP, Woodhead Publ |place=Oxford |isbn=978-0-85709-254-0 |oclc=838321011}}</ref><ref>{{Cite journal |last=Wolinsky |first=Howard |last2=Husted |first2=Kristofor |date=2015-03 |title=Science for food: Molecular biology contributes to the production and preparation of food |url=https://onlinelibrary.wiley.com/doi/10.15252/embr.201540128 |journal=EMBO reports |language=en |volume=16 |issue=3 |pages=272–275 |doi=10.15252/embr.201540128 |issn=1469-221X |pmc=PMC4364866 |pmid=25691389}}</ref><ref>{{Cite journal |last=Jayashree |first=B |last2=Reddy |first2=Praveen T |last3=Leeladevi |first3=Y |last4=Crouch |first4=Jonathan H |last5=Mahalakshmi |first5=V |last6=Buhariwalla |first6=Hutokshi K |last7=Eshwar |first7=Ke |last8=Mace |first8=Emma |last9=Folksterma |first9=Rolf |last10=Senthilvel |first10=S |last11=Varshney |first11=Rajeev K |date=2006-12 |title=Laboratory Information Management Software for genotyping workflows: applications in high throughput crop genotyping |journal=BMC Bioinformatics |language=en |volume=7 |issue=1 |pages=383 |doi=10.1186/1471-2105-7-383 |issn=1471-2105 |pmc=PMC1559653 |pmid=16914063}}</ref><ref name="ThermoNucleicAcid">{{cite web |url=https://www.thermofisher.com/us/en/home/industrial/food-beverage/food-analytical-testing/sample-prep-nucleic-acid-protein-isolation.html |title=Nucleic Acid Extraction For Food And Beverage Testing |publisher=Thermo Fisher Scientific |accessdate=07 December 2022}}</ref>:
 
*'''Manage stability studies''': Just as with the pharmaceutical industry, stability studies play an important role in food and beverage safety. These studies require careful statistical analysis, predictive modelling, sensory analysis, quantitative descriptive testing, discrimination testing, microbiology testing, and more. This translates to a need for a wide variety of analytical and visualization tools, as well as LIMS support for a wide variety of test methods and limits. A robust LIMS should have these abilities, but not all do.
*'''Manage recipes, as well as master and batch production records''': This functionality is more in the domain of the LES or manufacturing execution system (MES). However, a few LIMS vendors may extend their LIMS to provide these features. Given that the HACCP rules, in particular, mandate the creation and management of batch production and in-process manufacturing material records, some food and beverage facilities testing batches and manufacturing materials may appreciate support in this regard.
*'''Support molecular biology workflows''': Molecular biology is an important tool in the research of improving foods, beverages, and their ingredients. However, not all LIMS are ideally equipped to handle related workflow aspects such as nucleic acid extraction, protein and cell isolation, and genotyping. A lab using such techniques may have to do extra due diligence in finding a food and beverage LIMS that also supports these workflow tasks.
*'''Take advantage of ELN functionality''':  Given the level of R&D to be found in a food and beverage facility, the ELN is a familiar companion to other informatics systems. A few LIMS vendors may have a built-in ELN with their LIMS or offer an ELN that comes readily integrated with the LIMS. Some elements of ELN functionality may even be found in a few solutions. At a minimum—and nodded to in the base functionality above—the LIMS should support ELN functionality through its ability to effectively connect to a third-party ELN.
*'''Develop regulatory-driven safety plans''': The Hazard Analysis and Critical Control Points (HACCP) quality control method is recommended or required for food and testing labs (and is an influence on ISO 17025). Some LIMS vendors have recognized this and integrated support for building HACCP steps into laboratory workflows. In some cases this may be as sophisticated as allowing the user to diagram HACCP in their lab or facility as a visualization tool.
*'''Generate schedules for environmental testing''': While a LIMS can help assign and schedule a variety of laboratory tasks, broader organizational goals of testing the production environment on a scheduled, reportable basis may not be so straightforward, particularly without facility and sampling site management functionality that allows for highlighting specific test points in the facility. Even offsite or randomized testing may not be fully supported by a generic LIMS, requiring a LIMS flexible enough to compensate for the need for broader scheduled and randomized testing and retesting.
*'''Improve reaction time to non-conformances''': Many LIMS will have some basic form of non-conformance and incident management tools, but the robustness and extensibility of that functionality may be lacking. Can it send an SMS or email to the appropriate supplier in real-time when a pre-defined set of circumstances concerning that supplier's ingredients occurs? Can it re-prioritize or pause other related activities that are scheduled due to the identified non-conformance or incident? This is a useful area of functionality for the potential LIMS buyer to confirm with a vendor.
*'''Improve audit readiness and reporting''': A LIMS worth its weight will have a robust audit trail, to be sure. But can your LIMS help you audit your suppliers? Can it capture internal audit data on-demand and directly from the facility floor via mobile-friendly forms? Can HACCP- and audit-related data be flagged as such to make retrieval more efficient for audit purposes? These and other considerations may be important to a food and beverage facility, and not all food and beverage LIMS can provide.
 
====3.1.3 Cybersecurity considerations====
From law firms<ref name="SobowaleLaw17">{{cite web |url=http://www.abajournal.com/magazine/article/managing_cybersecurity_risk/ |title=Law firms must manage cybersecurity risks |author=Sobowale, J. |work=ABA Journal |publisher=American Bar Association |date=01 March 2017 |accessdate=07 December 2022}}</ref> to automotive manufacturers<ref name="WatneyAddress17">{{cite web |url=https://www.rstreet.org/wp-content/uploads/2018/04/118-1.pdf |format=PDF |title=Addressing new challenges in automotive cybersecurity |author=Watney, C.; Draffin, C. |work=R Street Policy Study No. 118 |publisher=R Street Institute |date=November 2017 |accessdate=07 December 2022}}</ref>, the need to address cybersecurity is increasingly apparent. In 2018, the Center for Strategic & International Studies estimated that cybercrime causes close to $600 billion in damages to the global economy every year<ref name="LewisEcon18">{{cite web |url=https://www.csis.org/analysis/economic-impact-cybercrime |title=Economic Impact of Cybercrime |author=Lewis, J.A. |publisher=Center for Strategic & International Studies |date=21 February 2018 |accessdate=07 December 2022}}</ref>, though due to underreporting of crimes, that number may be much higher. That number also likely doesn't take into account lost business, fines, litigation, and intangible losses<ref name="SBDCC_BlogCost17">{{cite web |url=https://www.virginiasbdc.org/blog-cost-of-cyber-crime-to-small-businesses/ |archiveurl=https://web.archive.org/web/20200705061737/https://www.virginiasbdc.org/blog-cost-of-cyber-crime-to-small-businesses/ |title=BLOG: Cost of Cyber Crime to Small Businesses |work=Virginia SBDC Blog |publisher=Virginia SBDC |date=30 May 2017 |archivedate=05 July 2020 |accessdate=07 December 2022}}</ref> In the end, businesses of all sizes average about $200,000 in losses due to a cybersecurity incident<ref name="HiscoxHiscox19&quot;">{{cite web |url=https://www.hiscox.com/documents/2019-Hiscox-Cyber-Readiness-Report.pdf |format=PDF |title=Hiscox Cyber Readiness Report 2019 |publisher=Hiscox Ltd |date=April 2019 |accessdate=07 December 2022}}</ref>, and nearly 60 percent of small and midsize businesses go bankrupt within six months because of it.<ref name="Galvin60_18">{{cite web |url=https://www.inc.com/joe-galvin/60-percent-of-small-businesses-fold-within-6-months-of-a-cyber-attack-heres-how-to-protect-yourself.html |title=60 Percent of Small Businesses Fold Within 6 Months of a Cyber Attack. Here's How to Protect Yourself |author=Galvin, J. |work=Inc.com |date=07 May 2018 |accessdate=07 December 2022}}</ref>
 
Food and beverage laboratories are no exception, regardless of business size. Even tiny labs whose primary digital footprint is a WordPress website advertising their lab are at risk, as hackers could still spread malware, steal user data, add the website to a bot network, hack the site for the learning experience, or even hack it just for fun.<ref name="GrimaTop19">{{cite web |url=https://www.wpwhitesecurity.com/why-malicious-hacker-target-wordpress/ |title=Top reasons why WordPress websites get hacked (and how you can stop it) |author=Grima, M. |publisher=WP White Security |date=15 June 2022 |accessdate=07 December 2022}}</ref><ref name="MoenWhatHack16">{{cite web |url=https://www.wordfence.com/blog/2016/04/hackers-compromised-wordpress-sites/ |title=What Hackers Do With Compromised WordPress Sites |author=Moen, D. |work=Wordfence Blog |publisher=Defiant, Inc |date=19 April 2016 |accessdate=07 December 2022}}</ref><ref name="TalalevWebsite19">{{cite web |url=https://patchstack.com/articles/website-hacking-statistics/ |title=Website Hacking Statistics You Should Know in 2022 |author=Talaleve, A. |publisher=Patchstack |date=22 February 2022 |accessdate=07 December 2022}}</ref> Even more importantly are those labs performing digital data management tasks that handle sensitive proprietary manufacturer data, requiring additional cybersecurity considerations.
 
A food and beverage manufacturer and its associated laboratories can integrate cybersecurity thinking into its laboratory informatics product selection in several ways. First, the organization should have a cybersecurity plan in place, or if not, it should be on the radar. This is a good resource to tap into in regards to deciding what cybersecurity considerations should be made for the software. Can the software help your organization meet your cybersecurity goals? What regulatory requirements for your lab are or are not covered by the software?<ref name="DouglasComp20" /> Another tool to consider—which may have been used in any prior cybersecurity planning efforts—is a cybersecurity framework. Many, but not all, cybersecurity frameworks include a catalog of security controls. Each control is "a safeguard or countermeasure prescribed for an information system or an organization designed to protect the confidentiality, integrity, and availability of its information and to meet a set of defined security requirements."<ref name="NISTSecurity19">{{cite web |url=https://csrc.nist.gov/glossary/term/security_control |title=security control |work=Computer Security Resource Center |publisher=National Institute of Standards and Technology |date=2019 |accessdate=07 December 2022}}</ref> These controls give the implementing organization a concrete set of configurable goals to apply to their overall cybersecurity strategy. Other frameworks may be less oriented to security controls and more program-based or risk-based. Choosing the best frameworks will likely depend on multiple factors, including the organization's industry type, the amount of technical expertise within the organization, the budget, the organizational goals, the amount of buy-in from key organizational stakeholders, and those stakeholders' preferred approach.<ref name="DouglasComp20" />
 
Finally, having an organizational cybersecurity plan that incorporates one or more cybersecurity frameworks gives the laboratory ample opportunity to apply stated goals and chosen security controls to the evaluation and selection process for its informatics software. In particular, a user requirements specification (URS) that incorporates cybersecurity considerations will certainly help a laboratory with meeting regulatory requirements while also protecting its data systems. A USR that is pre-built with cybersecurity controls in mind—such as [[Book:LIMSpec 2022 R2|LIMSpec]], discussed later—makes the evaluation process even easier.
 
====3.1.4 Regulatory compliance considerations====
Without a doubt, it's vital that food and beverage laboratories operate within the bounds of a regulatory atmosphere, not only to better ensure the best consumer satisfaction outcomes but also to ensure the quality of test results, the safety of end users, and the promise of maintaining traceability across the utilized food chain. Maintaining regulatory compliance requires deliberate approaches to developing and enforcing processes and procedures, quality training, consistent communication, and knowledgeable personnel. It also requires a top-down appreciation and commitment to a culture of quality. From ISO/TS 22002-1:2009 ''Prerequisite programmes on food safety — Part 1: Food manufacturing'' and Codex Alimentarius CXS 234-1999 ''Recommended Methods of Analysis and Sampling'' to 21 CFR Part 120 (concerning hazard analysis and critical control point [HACCP] systems) and Safe Food for Canadians Regulations SOR/2018-108, laboratories have much to consider in regards to what standards and regulations impact them.
 
That said, consider approaching the question of regulatory compliance from the standpoint of adopting standards. Consider first that the risks and consequences of performing a task poorly drives regulation and, more preferably<ref name="CiocoiuTheRole10">{{cite book |chapter=Chapter 1. The Role of Standardization in Improving the Effectiveness of Integrated Risk Management |title=Advances in Risk Management |author=Ciocoui, C.N.; Dobrea, R.C. |editor=Nota, G. |publisher=IntechOpen |year=2010 |isbn=9789535159469 |doi=10.5772/9893}}</ref><ref name="JPMorganData18">{{cite web |url=https://www.jpmorganchase.com/content/dam/jpmc/jpmorgan-chase-and-co/documents/call-to-action.pdf |format=PDF |title=Data Standardization: A Call to Action |publisher=JPMorgan Chase & Co |date=May 2018 |accessdate=07 December 2022}}</ref>, standardization, which in turn moves the "goalposts" of quality and security among organizations. In the case of regulations, those organization that get caught not conforming to the necessary regulations tend to suffer negative consequences, providing some incentive for them to improve organizational processes and procedures.
 
One of the downsides of regulations is that they can at times be "imprecise" or "disconnected"<ref name="JPMorganData18" /> from what actually occurs within the organization and its information systems. Rather than focusing heavily on regulatory conformance, well-designed standards may, when adopted, provide a clearer path of opportunity for organizations to improve their operational culture and outcomes, particularly since standards are usually developed with a broader consensus of interested individuals with expertise in a given field.<ref name="CiocoiuTheRole10" /> In turn, the organizations that adopt well-designed standards likely have a better chance of conforming to the regulations they must, and they'll likely have more interest in maintaining and improving the goalposts of quality and security in the lab.
 
Additionally, reputable software developers of laboratory informatics software will not only adopt their own industry standards for software development but also understand the standards and regulations that affect food and beverage laboratories. In turn, the developed software should meet regulations and standards, help the laboratory comply with its regulations and standards, and be of reliably good quality.
 
If you're a potential buyer of a laboratory informatics solution, it may be that you know a bit about your laboratory's workflow and a few of the regulations and standards that influence how that workflow is conducted, but you're not entirely informed about all the regulations and standards that affect your lab. Turning to a URS such as LIMSpec—which was developed around laboratory regulations and standards—and reviewing the various statements contained within may be necessary to help further inform you. Additionally, as you investigate various informatics options, you can then use the requirements in the URS as a base for your laboratory's own requirements list. Using the categories and their subdivisions, you can then add those requirements that are unique to your laboratory and industry that are not sufficiently covered by the base URS. As you review the various options available to you and narrow down your search, your own list of requirements can be used as both as a personal checklist and as a requirements list you hand over to the vendor you query. And since your URS is based off the standards and regulations affecting your lab, you can feel more confident in your acquisition and its integration into your laboratory workflow.
 
====3.1.5 System flexibility====
Before selecting a solution, your laboratory should also have internal discussions about how diversified its offered services are, as well as what the future may bring to the lab. If, for example, your lab is currently configured for food authenticity and adulteration testing, does your existing laboratory informatics system—or the ones you may be considering—have the flexibility to add other types of food and beverage testing, protocols, and workflows? Will you be doing the footwork to add them, or will the vendor of your system support you in that effort? If you're a start-up, will your lab be focusing solely on a specific type of food testing and expand into other types of analytical work later, or will your test menu need to be much broader right from the start? In most of these cases, you'll desire a LIMS that is flexible enough to allow for not only running the specific tests you need now, but also sufficiently expandable for any future testing services your lab may conduct in the mid- and long-term. Having the ability to create and customize [[Sample (material)|sample]] registration screens, test protocols, labels, reports, specification limit sets, measurement units, and substrates/matrices while being able to interface with practically most any instrument and software system required will go a long way towards making your expanding test menu and workflows integrates as smoothly as possible.
 
Such a system will typically be marketed as being highly user-configurable, giving labs a relatively painless means to adapt to rapid changes in test volume and type over time. However, once you've internally addressed current and anticipated future growth, your lab will want to learn what explicitly makes any given vendor's system user-configurable. How easy is it to configure the system to new tests? Add custom reports? What knowledge or skills will be required of your lab in order to make the necessary changes, i.e., will your staff require programming skills, or are the administrator and advanced user functions robust enough to make changes without hard-coding? These and other such questions should be fully addressed by the vendor in order to set your mind at ease towards a system's stated flexibility. Ultimately, you want the system to be flexible enough to change with the laboratory—and industry—itself, while minimizing overall costs and reducing the time required to make any necessary modifications.
 
====3.1.6 Cost considerations====
First, you'll want to be clear on what will be included in the sales agreement. Whether through an estimate or statement of work (SOW), it is important it includes exactly what is expected, being as specific as possible, since this will be the entire contractual obligation for both you the buyer and them the vendor. Note that line items may differ slightly from system to system, according to what features and functions are included by default with each vendor's solution and which, if any, are additional. Also keep in mind that any hourly amount in the the estimate or SOW is usually a best estimate; however, if sufficient attention to detailed requirements has been given, then it should be quite accurate, and in fact the final cost may even be below the quoted cost if you prioritize your own obligations so that the vendor's hours are used sparingly and efficiently.
 
The estimate or SOW should optimally include:
 
*licensing or subscription rates;
*required core items to meet federal, state, and local regulations;
*additional optional items and totals; and
*required services (implementation, maintenance and support, optional add-ons).
 
There are two primary ways to price a laboratory informatics solution: a one-time license fee or a subscription rate ([[Cloud computing|cloud-hosted]] [[software as a service]] [SaaS]). If you have your own dedicated IT department and staff, you may prefer the former (although many system administrators are just as happy to let it be hosted elsewhere rather than add to their workload). Otherwise, a SaaS subscription may well be the better and more cost-effective way to go (since the primary IT cost is simply internet access). This item will be part of your up-front cost and, in the case of subscription, it will also figure into your first year and ongoing costs; otherwise only associated maintenance, support, and warranty (MSW) will figure in. Typically, your first year's subscription costs will be due at signing. More often, the vendor may require three months or even the first year up front, so be prepared to factor that into up-front costs. However, it still is almost always less expensive at the outset (and over time, if you factor in IT costs and annual MSW) than paying for a license fee.
 
In addition to the two types of software pricing, there are also sub-types. Generally these are based on the number of users (or, in some cases, "nodes," which are simply any entities that access the informatics system, including other systems, instruments, etc.). How these are counted can vary.
 
*Named users: This method bases pricing on the actual individual users of the system, even if they only log in sporadically. Users may not use each other's logins (this is a no-no regardless of pricing structure, for good laboratory practice and other regulatory reasons).
*Concurrent users: This bases pricing on the maximum number of users who will be logged in at any given time. You can define an unlimited number of named users in the system, each with their own login credentials. However, only the number of concurrent users specified in the license or subscription may be logged in at any one time. For example, you may have 10 staff, but due to work processes, shifts, etc., only up to six might ever be logged in simultaneously. Whereas this would require a named user license for 10, it would only require a concurrent user license for six.
*Unlimited users: In the case of very large labs (typically 30 to 50 and up), the license or subscription may simply be a flat fee that allows any number of users.
 
The line items in the estimate or SOW should reflect these nuances, as well as whether the listed costs are monthly or annual (for subscription services), hourly (typically for support and training), or a fixed one-time cost. Additionally, be cautious with fixed costs, as they typically represent one of two possible scenarios:
 
#Final fixed cost: In this case, the cost has been figured by the vendor so as to cover their worst-case hourly labor total. If a line item (e.g., an interface) is not "worst case," then you are overpaying.
#"Expandable" fixed cost: This is as bad as final fixed cost, and maybe even worse because it's almost a case of "bait-and-switch," popping up as a surprise. The initial "fixed cost" number is low, and additional hourly services are needed to actually deliver the item. This will have been provided for somewhere in the small print.
 
The bottom line is that everything in a laboratory informatics solution is really either licensing or hourly services. Just be careful if they are portrayed as anything else.
 
It is important to be clear which category each line item falls under when figuring costs: up-front (due upon signing), annual, or ongoing (e.g., SaaS subscription). It is useful to clearly lay out each and compute initial costs, as well as first-year and subsequent years' costings. For example, your initial obligation may be as little as your first year's subscription plus the first 40 hours of services. Different vendors have different policies, however, and you may be required to pay for your first full year's subscription and all services, or some other combination. Normally, though, any instrument interface or other service charges aren't due until the they are implemented, which may be a few weeks or even a month down the road. This may depend on your budget, complexity of the SOW, and urgency. Your first year's expenses will include everything, including initial license fees; all setup and training; any interfaces and additional configurations or customization; and first annual MSW. (If this isn't included in the SaaS subscription, then it usually commences on full system delivery). Afterwards, your subscription and MSW will be the only ongoing expenses (included as one in this example), unless you choose to have additional interfaces or other services performed at any time.
 
 
===3.2 Implementation===
If you've ever worked through a system implementation process with a vendor, it was hopefully a smooth process. However, there are plenty of horror stories out there, highlighting the need of the laboratory to discuss in detail how a potential vendor will handle installation, validation, and training for the informatics solution. Does the vendor truly understand the industry and your needs? Does the vendor assign a project manager who will work with you, from planning to go-live and beyond? Can they offer you references of other labs who have gone through implementation so you can compare notes with those labs? How much attention does the potential vendor give to related issues such as data integrity of migrated data? Do they have the means to properly handle your legacy data? And are they able to work with your schedule, even if it means implementing software at off-peak work hours?<ref name="Wagner7Soft19">{{cite web |url=https://blog.walkme.com/7-software-implementation-challenges/ |title=7 Software Implementation Challenges and How to Solve Them |author=Wagner, M. |work=WalkMe Blog |publisher=WalkMe Ltd |date=10 October 2019 |accessdate=07 December 2022}}</ref><ref name="MuraBullet18">{{cite web |url=https://www.userlane.com/software-implementation-plan/ |title=Bullet-Proof Software Implementation Plan: Challenges and Tactics |author=Mura, A. |work=Userlane Digital Adoption Blog |publisher=Userlane GmbH |date=12 July 2018 |accessdate=07 December 2022}}</ref>
 
As you finally get down to the ultimate decision on which vendor to work with, you may wish to start setting up an implementation checklist as part of your early project planning. Do you receive a help desk account as part of the implementation process, and if so, what information is included? If not, you'll need to keep track of specific details such as business associate agreement (BAA), sales agreement, scope documents, welcome letters, documentation, and approved staff who can utilize the vendor's support. You'll likely need to share other configuration details with the vendor, including time zone requirements, DNS and URL requirements, up-time monitors, and administrative account requirements. Finally, you'll want to ensure you and the vendor are on the same page concerning any additional customization, integration, and system validation requirements, ensuring the roll-out period is pain-free and efficient.
 
====3.2.1 Internal and external integrations====
Laboratories acquire data management software for many reasons, including improving accuracy, saving time, increasing productivity, and adding capabilities. One way of doing all of those activities is to integrate or interface your systems, databases, and instruments so that human error is greatly reduced or eliminated, workflows are automated and sped up, and each component's capabilities are brought into play in the most efficient and effective ways possible. As such, you'll want to inquire with the vendor about its solution's hardware and software integration capabilities. Is it designed to interface with every laboratory instrument or software that can output any readable electronic file? Or are integrations limited to certain instruments and systems? How does it connect, i.e., what protocols does the software depend on to connect with other systems? Does the system allow a user to map their own file imports and exports? Can system processes be set to detect new instances of file outputs at regular intervals? Ask these and other questions to make sure the vendor clearly describes what internal and external integrations are supported with their application.
 
In many cases, a vendor's LIMS solution will have instrument integration capability built into the software, but occasionally such interfaces are separate from the main software. Today's instrument interfaces are generally built on standardized communication protocols such as RS-232, RS-422, IEEE-488 (GPIB), USB, Ethernet, and more.<ref name="WilliamsComp">{{cite web |url=https://newton.ex.ac.uk/teaching/CDHW/Interfaces/ |title=Computer Interfaces for Instrumentation Systems |author=Williams, C.D.H. |publisher=University of Exeter |accessdate=07 December 2022}}</ref> The LIMS that can support such instrument integrations is increasingly vital to the food and beverage laboratory. Food and beverage labs may also want their laboratory informatics solution to be able to communicate with other software and databases. This is often done using [[application programming interface]]s (APIs) that depend on web services implementation protocols such as REST and SOAP.<ref name="MonusSOAP19">{{cite web |url=https://raygun.com/blog/soap-vs-rest-vs-json/ |title=SOAP vs REST vs JSON - a 2023 comparison |author=Monus, A. |work=Raygun |date=17 October 2022 |accessdate=07 December 2022}}</ref><ref name="LVAQuick18">{{cite web |url=https://www.labvantage.com/a-quick-guide-to-lims-web-services/ |title=A Quick Guide to LIMS Web Services |author=LabVantage Solutions |publisher=LabVantage Solutions, Inc |date=07 January 2018 |accessdate=07 December 2022}}</ref><ref name="GrandOneTool19">{{cite journal |title=One tool to find them all: A case of data integration and querying in a distributed LIMS platform |journal=Database |author=Grand, A.; Geda, E.; Mignone, A. et al. |volume=2019 |page=baz004 |year=2019 |doi=10.1093/database/baz004}}</ref> These messaging protocols actually allow for the creation of an API that receives communication requests and sends responses between two software systems. A more practical example is wanting your laboratory informatics solution to communicate with an [[enterprise resource planning]] (ERP) application. Perhaps the ERP system needs to create sample batches within the informatics solution, and when testing is done, have the results returned to the ERP. APIs and communication protocols make this happen.<ref name="LVAQuick18" />
 
 
===3.3 MSW, updates, and other contracted services===
The maintenance, support, and warranty (MSW) offered with the vendor's solution is almost as important as the solution itself. The laboratory informatics solution you acquire is more than than the software you operate: it's mission-critical and deserves having a reliable and responsive team with the necessary resources to ensure it remains operational. Downtime can negatively affect both immediate customer satisfaction and your reputation. As such, it's imperative you ask the vendor about the details of its MSW, making sure you understand what is and isn't covered, as well as how much it will cost. Cost-wise, industry norms are anywhere from 15% to 25% of either the license fee or total contract, levied annually to provide this coverage.<ref name="ScavoHigh05">{{cite web |url=https://www.computereconomics.com/article.cfm?id=1033 |title=High Software Maintenance Fees and What to Do About Them |author=Scavo, F. |work=Computer Economics |date=08 February 2005 |accessdate=07 December 2022}}</ref> Alternatively, it may simply be included with your subscription. The MSW will include a specified number of support and maintenance hours or guarantees. The actual warranty should be unlimited for as long as the MSW or subscription is kept current.
 
Maintenance includes any and all work necessary to keep your system working as designed. It should include updates, patches, or fixes, and most if not all upgrades. (Note, however, a major upgrade to a totally new edition may not be covered, but it may come at a negotiable, significantly lower cost.<ref name="Gordon-ByrneMaint14">{{cite web |url=http://www.ittoday.info/ITPerformanceImprovement/Articles/2014-08GordonByrne2.html |archiveurl=https://web.archive.org/web/20210505220938/http://www.ittoday.info/ITPerformanceImprovement/Articles/2014-08GordonByrne2.html |title=Maintenance in the Digital World |author=Gordon-Byrne, G. |work=IT Performance Improvement |publisher=Taylor & Francis, LLC |date=2014 |archivedate=05 May 2021 |accessdate=07 December 2022}}</ref>) The support aspect of MSW generally consists of a specified number of hours dedicated more to helping you with the operation of the system rather than "fixing" anything. Support includes guidance on training, password or login support, and more. Finally, with any professional application you also expect to have a warranty. The warranty should cover anything that doesn't work that otherwise should for the designated period of time.<ref name="Gordon-ByrneMaint14" /> That includes any standard features and functions, as well as any additional ones that were delivered and signed off on, and any other work performed by the vendor or its representatives. However, a typical warranty does not cover anything that was working fine, but upon being manipulated in a way beyond normal operation the functionality ceased. In these cases, you'll probably have to pay to get it fixed.
 
Beyond the MSW, additional updates and services related to the system may also be required. No matter how well it is pre-configured, any professional laboratory informatics solution will require some amount of standard setup to reflect your particular lab. This includes adding lab branding and demographics for reports and certificates; entering users, their roles, and access permissions; adding and/or modifying tests and workflows; renaming fields; adding or hiding fields; setting up a web portal; and implementing interfaces. Equally indispensable is proper training for both users and administrators. And of course you may later find that you would like additional features or functions. These and other services may prove particularly useful to the laboratory with little in the way of IT and systems expertise. As such, the vendor may provide one or more of the following as a billable service for the laboratory:
 
*initial implementation meeting (e.g., initial planning, identify delta, set schedule)
*project management
*requirements gathering and documentation
*initial setup
*user and administrator training
*configuration and customization
*interface development and implementation
*custom screen and field development
*custom functionality development
*custom reports and labels
*custom triggers and alerts
*validation or acceptance testing (to a third-party standard or certification, or to agreed manufacturer specs)
 
 
===3.4 How a user requirements specification fits into the entire process (LIMSpec)===
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=07 December 2022}}</ref> In other words, an existing or theoretical product, concept, or idea is presented in detail for a particular audience. In a broad sense, detailing the specifics about a project, concept, or idea to others is just common sense. This applies just as well to the world of software development, where a software requirements specification is essential for preventing the second most commonly cited reason for project failure: poor requirements management.<ref name="BiegRequire14">{{cite web |url=https://www.pmi.org/-/media/pmi/documents/public/pdf/learning/thought-leadership/pulse/requirements-management.pdf |format=PDF |title=Introduction |work=Requirements Management: A Core Competency for Project and Program Success |author=Bieg, D.P. |publisher=Project Management Institute |page=3 |date=August 2014 |accessdate=07 December 2022}}</ref>
 
In fact, the ISO/IEC/IEEE 29148:2018 standard (a conglomeration of what was formerly IEEE 830 and other standards) is in place to help specify "the required processes implemented in the engineering activities that result in requirements for systems and software products" and provide guidelines for how to apply those requirements.<ref name="ISO29148">{{cite web |url=https://www.iso.org/standard/72089.html |title=ISO/IEC/IEEE 29148:2018 |publisher=International Organization for Standardization |date=November 2018 |accessdate=07 December 2022}}</ref> The standard describes the characteristics that make up quality software requirement development, including aspects such as<ref name="SeibertHowDoYou11">{{cite web |url=https://hubtechinsider.wordpress.com/2011/07/28/how-do-you-write-software-requirements-what-are-software-requirements-what-is-a-software-requirement/ |title=How do you write software requirements? What are software requirements? What is a software requirement? |work=HubTechInsider |author=Seibert, P. |date=28 July 2011 |accessdate=07 December 2022}}</ref>:


==Citation information for this chapter==
*correctly describing system behavior;
'''Chapter''': 5. Staffing and education requirements
*effectively removing ambiguity from the language used;
*completely covering the system behavior and features;
*accurately prioritizing and ranking the requirements; and
*unequivocally ensuring the requirements are testable, modifiable, and traceable.


'''Title''': ''The Comprehensive Guide to Physician Office Laboratory Setup and Operation''
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 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.


'''Author for citation''': Shawn E. Douglas
This is where a requirements specification shines, not only for the software developer but also for those acquiring the software. A set of development requirements, compiled in the form of a software requirements specification, can serve to strengthen the software development process. For those acquiring the software, a set of user requirements, compiled in the form of a user requirements specification (URS), can be used for the selection and acquisition of software or a service.<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=07 December 2022}}</ref><ref name="SchmittUser18">{{cite journal |title=User Requirements Specifications–How Difficult Can It Be? |journal=Pharmaceutical Technology |author=Schmitt, S. |volume=42 |issue=11 |page=58 |year=2018 |url=https://www.pharmtech.com/view/user-requirements-specifications-how-difficult-can-it-be-0 |accessdate=07 December 2022}}</ref> In the case of the URS, the acquiring business can approach this several ways. The simple way would be to essentially take the vendor at the word in regards to what they say their system can and can't do, agreeing formally to their description and taking responsibility that it will cover all the applicable regulations required by your business. However, this method isn't comprehensive and leaves the business open to not being able to fully meet its goals.<ref name="SchmittUser18" />


'''License for content''': [https://creativecommons.org/licenses/by-sa/4.0/ Creative Commons Attribution-ShareAlike 4.0 International]
The other method has the URS be specific to your business' needs. The process is more work but leaves less to chance.<ref name="SchmittUser18" /> Developing your own URS isn't always straightforward. Often times, the developed document turns into a mix of "wishlist" requirements from potential and active clients, as well as regulation-mandated requirements. The wishlist items aren't necessarily ignored by developers, but the URS should in fact clearly prioritize requirements 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=07 December 2022}}</ref><ref name="BurrissSoftware07">{{cite web |url=http://sce2.umkc.edu/BIT/burrise/pl/requirements/ |archiveurl=https://web.archive.org/web/20190925003040/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=25 September 2019 |accessdate=07 December 2022}}</ref> Whatever the URS looks like in the end, it's ultimately up to the vendor to be able to demonstrate how the software does and does not meet its requirements.


'''Publication date''': June 2015
In the latter half of this guide, you'll be given an opportunity to see an example of a URS for the food and beverage industry in the form of LIMSpec, an evolving set of software requirements specifications for laboratory informatics systems. Built from requirements found in [[ASTM E1578|ASTM E1578-18]] ''Standard Guide for Laboratory Informatics'', as well as dozens of other standards and regulations, we will use LIMSpec to demonstrate how a URS can be put to use, while also showing you how an informatics system can help you laboratory better meet regulatory requirements.


<!--Place all category tags here-->
==References==
{{Reflist|colwidth=30em}}

Revision as of 18:43, 7 December 2022

3. Choosing laboratory informatics software for your food and beverage lab

Computers in the laboratory are not a recent phenomenon. The mid-1960s saw laboratory computerization become increasingly popular[1][2][3][4][5], though that enthusiasm was often based on the potential of the computers themselves rather than their actual capabilities.[1] Laboratorians imagined potentials such as automatic sample label generation, daily log and report management, instrument interfacing and data processing, results comparisons, and time management tools. However, it would take time for some of those potentials to be realized.[1]

In 1970, Temple University's Marion Ball, M.A., an assistant professor in the Department of Medical Physics, conducted a survey of pathology directors in clinical laboratories that were using computers. Asking their opinions about the advantages and disadvantages of computerized systems in the lab, she received responses from directors in 15 U.S. states, as well as from three other countries. Responses included[6]:

The ability to rapidly prepare cumulative records and then to inspect them for possible errors through analysis trends has been proven to be of tremendous advantage in a number of laboratories. We can prevent errors in our analytical systems, but we are not prepared to prevent errors in the collecting of the sample, the mislabeling of the sample, or the accidental use of an incorrect sample. Thus, the ability to inspect data trends presents the only real tool that we currently have to pick out these kinds of errors. - Max E. Chilcote, Ph.D, Meyer Memorial Hospital Division

There is little argument about whether an operating computer system can be an advantage in a laboratory, but the most critical time is the installation and transition from a "manual" to a "computer" oriented laboratory. - Robert L. Habig, Duke University Medical Center

Reading about these potentials and opinions today, some 50 years later, we see both clear similarities and definite advances. For example, Habig's statement about transitioning from manual to more automated processes still rings true today: it can be nerve wracking and critical to get the transition right. Conversely, while the systems of decades past weren't able to "prevent errors in the collecting of the sample, the mislabeling of the sample, or the accidental use of an incorrect sample," modern laboratory informatics systems provide many assurances to sample management in the lab. In many cases, activities such as label generation, reporting, results analysis, workflow control, test ordering, and broad interoperability are commonplace in modern systems.[7] And those systems continue to advance, with machine learning now finding its way into a few laboratory data management and analysis workflows.[8][9]

We've come a long way since the 1960s, to a point where the question is no longer "can a computerized system help my lab?" but rather "how do I choose and implement an informatics system to help my lab?" What follows is information to help you with that question, while considering the technology, features, security, cost, implementation, and vendor guarantees that come with such a system.


3.1 Evaluation and selection

What exactly is a laboratory information management system (LIMS) anyway? Do I need one? What options are available and how do I compare them? What about a request for information (RFI), request for proposal (RFP), or request for quotation (RFQ)? These are questions laboratory professionals typically ponder upon finding themselves charged with the mission of finding software for their food and beverage lab. For many the task can be a daunting proposition.

You may know the workflow-related needs of your laboratory, but perhaps you don't know much about data management solutions like LIMS, leaving you intimidated by all the options. You'll first need to gauge your lab's informatics needs in order to determine which products are worth investigating further. Of course your lab's analysis requirements, reporting and data sharing constraints, instrument interfacing needs, barcoding and tracking requirements, quality assurance processes, etc. are very important factors. But these systems vary in numerous ways, and other important factors exist. Price should certainly be considered, although value is ultimately more important than a low price. Other important questions that get asked include:

  • Should we purchase software licenses or "rent" the software via a subscription-based model?
  • Does the software need to be on-site, or is a SaaS hosted option more practical?
  • Is a modular or complete system better for us?
  • What is the best licensing/rental scheme for us? Should we consider site, named user, concurrent user, or workstation licenses?
  • Is the company qualified and trustworthy?
  • What functionality is available to help our lab not only accomplish workflow tasks but also remain regulatory compliant?

These and other questions are addressed in this chapter.

3.1.1 Technology considerations

Your laboratory's workflow, instruments, data management requirements, budget, technological expertise, business goals, and risk tolerances will all play a role in deciding what technology to invest in. The allergen, calorie, and nutrition testing lab, for example, may depend less on instrument integration than the stability, cycle, and challenge testing lab, with its microbiological workflows. As such, look at your laboratory's short- and long-term goals, budget, workflow, and regulatory requirements to gain a better understanding of what technology will be involved.

First, what are the laboratory's goals? Does the third-party laboratory owner envision a small investment, taking in a slow but steady flow of formulation requests, or do they envision expansive growth, expanding into multiple food and beverage testing domains? If the lab is starting small but is confidently expecting to grow, technological investments early on may want to take into account future technologies that may shape data management and security processes. Second, what kind of work will the lab be doing, and what regulatory responsibilities will guide hardware and software investment at the lab? If your lab will be conducting extractable and leachable testing, you'll be considering chromatography and spectroscopy instruments, as well as requirements for retaining analytical results for regulators. The Laboratory Accreditation for Analyses of Foods (LAAF)-accredited testing lab will likely have many more instruments to cover all its testing needs, and its data management system will likely need to be able to interface to U.S. Food and Drug Administration systems, or at a minimum report in their specific format. Third, your laboratory's budget is always important. Does the budget allow for on-site hardware and software systems, with the personnel to maintain them? Is it easier to pay up-front or find a vendor willing to work with you on leasing or rental terms? (We talk about other cost considerations a bit later.)

Finally, will the lab have someone on-site or on-call to resolve technology issues, including set-up and maintenance of software systems? If your lab will have little in the way of available tech help locally, you'll want to consider the distribution model you want to use for any installed software, i.e., you may want to consider software as a service (SaaS). An increasing number of software services are hosted using cloud computing, which when done well is an increasingly reliable option.[10] Having someone else host the software for you typically means the hosting provider will carry a non-trivial portion of responsibility for technology maintenance and security. Speaking of security, you'll also want to consider the cybersecurity (addressed later) of not only your software solution but also your overall laboratory operations. Does your organization have a cybersecurity plan already in place, or has the decision to make one been postponed? What extra investment is required to ensure your sensitive data is secure? Remember that how you rank your cybersecurity preparedness and implement a cybersecurity plan will also guide your technology investment decisions.[11]

3.1.1.1 Laboratory informatics options

Keeping the above in mind, what are the common software solutions used within a food and beverage laboratory? One of the more commonly discussed options is the LIMS, a laboratory informatics solution designed to assist laboratories with managing testing workflows, data, and other aspects of their operations.

The use of LIMS in food production facilities and labs is not a new concept.[12] However, little information can be found as to the percentage of today's food and beverage laboratories using a LIMS in their workflow. Several surveys from 2020, however, hint that LIMS are important to these types of labs. A survey of 135 professionals—nine percent of them from the food and beverage industry—from laboratory consultancy Astrix Technology found that more than 77 percent of respondents had at least one LIMS implemented in their organization.[13] A separate survey from Lab Manager about analytical instrument use among readers found that more than 16 percent of them were using instruments for food and beverage analysis.[14] Given the importance of integrating instrumentation and produced data in a food and beverage production and testing environment[15][16][17], a LIMS or other informatics solution appears to be increasingly critical to eliminating manual processes, improving sample management, increasing productivity, and improving regulatory conformance.[13] This, of course, lends to the food and beverage lab's focus on safety, quality, and compliance.

A LIMS can improve laboratory workflows and workloads while enhancing safety, quality, and compliance in a number of ways. A fragmented mix of paper-based and electronic information sources can be a detriment to the traceability of or rapid accessibility to ingredients, additives, quality control samples, standard operating procedures (SOPs), environmental monitoring data, chain of custody data, and other vital aspects of food and beverage production. A well-implemented LIMS can reduce the silos of information and data, while at the same time make that information and data more secure and readily accessible. Given the regulatory demands for providing rapid proof of traceable product movement and relevant quality control data, the LIMS acts as the central integrator and audit trail for that information.[15][18][19] Because the LIMS improves traceability—including through its automated interfaces with instruments and other data systems—real-time monitoring of supply chain issues, quality control data, instrument use, and more is further enabled, particularly when paired with configurable dashboards and alert mechanisms. By extension, food and beverage producers can more rapidly act on insights gained from those real-time dashboards.[15] This is also means that the food and beverage testing lab can react more rapidly to issues that compromise compliance with certification to the ISO 17025 standard or Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA) requirements.[16][20][21][22] Finally, many modern LIMS tailored to the food and beverage industry come pre-configured out of the box with analytical and quality control workflow support tools that can be further optimized to a lab's unique workflow.[23]

However, the LIMS is not the sole information management solution for food and beverage producers and laboratories. Software-based information management solutions are being marketed to food and beverage labs in other ways. Some vendors have taken to marketing the somewhat related laboratory execution system (LES), which tends to focus more on laboratory test method execution at the process level while integrating other R&D functionalities found in, for example, electronic laboratory notebooks (ELNs).[24][25] Other vendors have moved away from the "LIMS" and "LES" moniker completely, referring to their software as simply "food safety software." These offerings appear to focus on helping a producer do more than manage laboratory testing output by addressing other organizational needs such as developing regulatory-driven safety plans, generating schedules for environmental testing, improving communication and compliance, improving reaction time to non-conformances, improving audit readiness and reporting, ensuring greater compliance, and identifying trends across the entire enterprise.[26][27][28][29][30] In comparison, some LIMS may or may not address these issues; this functionality will be discussed further in the next subsection.

3.1.2 Features and functions

Given the above, it's clear LIMS adoption and use is important to the continued success of food and beverage labs. However, in most cases, a generic LIMS won't do; it's imperative the lab find a solution that meets all or most of its workflow requirements. This more often than not requires a configurable solution that enables trained users to quickly make the changes they need, if those changes make sense within the overall data structure of the LIMS. It also requires a solution that has been thoughtfully developed and continues to be carefully maintained to address the ever-shifting standard- and regulation-based requirements of the food and beverage laboratory. The following examines both the base features and specialty requirements of a food and beverage LIMS.

3.1.2.1 Base features

What follows is a list of system functionality important to most any food and beverage laboratory, with a majority of that functionality found in many vendor software solutions.[15][16][18][19][23][24][31]

Test, sample and result management

  • Sample log-in and management, with support for unique IDs
  • Sample batching
  • Barcode and RFID support
  • End-to-end sample and inventory tracking
  • Pre-defined and configurable industry-specific test and method management, including for bacteria (i.e., microbiology), heavy metals (i.e., chemistry), drug residues (i.e., pharmaceutical chemistry), and other substances
  • Pre-defined and configurable industry-specific workflows
  • Configurable screens and data fields
  • Specification management
  • Test, sampling, instrument, etc. scheduling and assignment
  • Test requesting
  • Data import and export
  • Robust query tools
  • Analytical tools, including data visualization, statistical analysis, and data mining tools
  • Document and image management
  • Version control
  • Project management
  • Method and protocol management
  • Investigation management
  • Facility and sampling site management
  • Storage management and monitoring

Quality, security, and compliance

  • Quality assurance / quality control mechanisms
  • Mechanisms for compliance with ISO 17025 and HACCP, including support for critical control point (CCP) specifications and limits
  • Result, method, protocol, batch, and material validation, review, and release
  • Data validation
  • Trend and control charting for statistical analysis and measurement of uncertainty
  • User qualification, performance, and training management
  • Audit trails and chain of custody support
  • Configurable and granular role-based security
  • Configurable system access and use (i.e., authentication requirements, account usage rules, account locking, etc.)
  • Electronic signature support
  • Data encryption and secure communication protocols
  • Archiving and retention of data and information
  • Configurable data backups
  • Status updates and alerts
  • Environmental monitoring support
  • Incident and non-conformance notification, tracking, and management

Operations management and reporting

  • Configurable dashboards for monitoring, by product, process, facility, etc.
  • Customizable rich-text reporting, with multiple supported output formats
  • Custom and industry-specific reporting, including certificates of analysis (CoAs)
  • Industry-compliant labeling
  • Email integration
  • Instrument interfacing and data management
  • Third-party software interfacing (e.g., LES, scientific data management system [SDMS], other database)
  • Data import, export, and archiving
  • Instrument calibration and maintenance tracking
  • Inventory and material management
  • Supplier/vendor/customer management
  • Integrated (or online) system help

3.1.2.2 Specialty features

As noted previously, some software vendors are addressing food and beverage processor needs beyond the basic laboratory through their food safety software. A standard LIMS tailored for the food and beverage industry may already contribute to some of these wider organizational functions, as well as more advanced laboratory workflow requirements, but many may not, or may vary in what additional functionality they provide. In that regard, a food and beverage LIMS vendor may also include specialized functionality that helps the food and beverage producer and its laboratory[24][26][27][28][30][31][32][33][34][35][36][37]:

  • Manage stability studies: Just as with the pharmaceutical industry, stability studies play an important role in food and beverage safety. These studies require careful statistical analysis, predictive modelling, sensory analysis, quantitative descriptive testing, discrimination testing, microbiology testing, and more. This translates to a need for a wide variety of analytical and visualization tools, as well as LIMS support for a wide variety of test methods and limits. A robust LIMS should have these abilities, but not all do.
  • Manage recipes, as well as master and batch production records: This functionality is more in the domain of the LES or manufacturing execution system (MES). However, a few LIMS vendors may extend their LIMS to provide these features. Given that the HACCP rules, in particular, mandate the creation and management of batch production and in-process manufacturing material records, some food and beverage facilities testing batches and manufacturing materials may appreciate support in this regard.
  • Support molecular biology workflows: Molecular biology is an important tool in the research of improving foods, beverages, and their ingredients. However, not all LIMS are ideally equipped to handle related workflow aspects such as nucleic acid extraction, protein and cell isolation, and genotyping. A lab using such techniques may have to do extra due diligence in finding a food and beverage LIMS that also supports these workflow tasks.
  • Take advantage of ELN functionality: Given the level of R&D to be found in a food and beverage facility, the ELN is a familiar companion to other informatics systems. A few LIMS vendors may have a built-in ELN with their LIMS or offer an ELN that comes readily integrated with the LIMS. Some elements of ELN functionality may even be found in a few solutions. At a minimum—and nodded to in the base functionality above—the LIMS should support ELN functionality through its ability to effectively connect to a third-party ELN.
  • Develop regulatory-driven safety plans: The Hazard Analysis and Critical Control Points (HACCP) quality control method is recommended or required for food and testing labs (and is an influence on ISO 17025). Some LIMS vendors have recognized this and integrated support for building HACCP steps into laboratory workflows. In some cases this may be as sophisticated as allowing the user to diagram HACCP in their lab or facility as a visualization tool.
  • Generate schedules for environmental testing: While a LIMS can help assign and schedule a variety of laboratory tasks, broader organizational goals of testing the production environment on a scheduled, reportable basis may not be so straightforward, particularly without facility and sampling site management functionality that allows for highlighting specific test points in the facility. Even offsite or randomized testing may not be fully supported by a generic LIMS, requiring a LIMS flexible enough to compensate for the need for broader scheduled and randomized testing and retesting.
  • Improve reaction time to non-conformances: Many LIMS will have some basic form of non-conformance and incident management tools, but the robustness and extensibility of that functionality may be lacking. Can it send an SMS or email to the appropriate supplier in real-time when a pre-defined set of circumstances concerning that supplier's ingredients occurs? Can it re-prioritize or pause other related activities that are scheduled due to the identified non-conformance or incident? This is a useful area of functionality for the potential LIMS buyer to confirm with a vendor.
  • Improve audit readiness and reporting: A LIMS worth its weight will have a robust audit trail, to be sure. But can your LIMS help you audit your suppliers? Can it capture internal audit data on-demand and directly from the facility floor via mobile-friendly forms? Can HACCP- and audit-related data be flagged as such to make retrieval more efficient for audit purposes? These and other considerations may be important to a food and beverage facility, and not all food and beverage LIMS can provide.

3.1.3 Cybersecurity considerations

From law firms[38] to automotive manufacturers[39], the need to address cybersecurity is increasingly apparent. In 2018, the Center for Strategic & International Studies estimated that cybercrime causes close to $600 billion in damages to the global economy every year[40], though due to underreporting of crimes, that number may be much higher. That number also likely doesn't take into account lost business, fines, litigation, and intangible losses[41] In the end, businesses of all sizes average about $200,000 in losses due to a cybersecurity incident[42], and nearly 60 percent of small and midsize businesses go bankrupt within six months because of it.[43]

Food and beverage laboratories are no exception, regardless of business size. Even tiny labs whose primary digital footprint is a WordPress website advertising their lab are at risk, as hackers could still spread malware, steal user data, add the website to a bot network, hack the site for the learning experience, or even hack it just for fun.[44][45][46] Even more importantly are those labs performing digital data management tasks that handle sensitive proprietary manufacturer data, requiring additional cybersecurity considerations.

A food and beverage manufacturer and its associated laboratories can integrate cybersecurity thinking into its laboratory informatics product selection in several ways. First, the organization should have a cybersecurity plan in place, or if not, it should be on the radar. This is a good resource to tap into in regards to deciding what cybersecurity considerations should be made for the software. Can the software help your organization meet your cybersecurity goals? What regulatory requirements for your lab are or are not covered by the software?[11] Another tool to consider—which may have been used in any prior cybersecurity planning efforts—is a cybersecurity framework. Many, but not all, cybersecurity frameworks include a catalog of security controls. Each control is "a safeguard or countermeasure prescribed for an information system or an organization designed to protect the confidentiality, integrity, and availability of its information and to meet a set of defined security requirements."[47] These controls give the implementing organization a concrete set of configurable goals to apply to their overall cybersecurity strategy. Other frameworks may be less oriented to security controls and more program-based or risk-based. Choosing the best frameworks will likely depend on multiple factors, including the organization's industry type, the amount of technical expertise within the organization, the budget, the organizational goals, the amount of buy-in from key organizational stakeholders, and those stakeholders' preferred approach.[11]

Finally, having an organizational cybersecurity plan that incorporates one or more cybersecurity frameworks gives the laboratory ample opportunity to apply stated goals and chosen security controls to the evaluation and selection process for its informatics software. In particular, a user requirements specification (URS) that incorporates cybersecurity considerations will certainly help a laboratory with meeting regulatory requirements while also protecting its data systems. A USR that is pre-built with cybersecurity controls in mind—such as LIMSpec, discussed later—makes the evaluation process even easier.

3.1.4 Regulatory compliance considerations

Without a doubt, it's vital that food and beverage laboratories operate within the bounds of a regulatory atmosphere, not only to better ensure the best consumer satisfaction outcomes but also to ensure the quality of test results, the safety of end users, and the promise of maintaining traceability across the utilized food chain. Maintaining regulatory compliance requires deliberate approaches to developing and enforcing processes and procedures, quality training, consistent communication, and knowledgeable personnel. It also requires a top-down appreciation and commitment to a culture of quality. From ISO/TS 22002-1:2009 Prerequisite programmes on food safety — Part 1: Food manufacturing and Codex Alimentarius CXS 234-1999 Recommended Methods of Analysis and Sampling to 21 CFR Part 120 (concerning hazard analysis and critical control point [HACCP] systems) and Safe Food for Canadians Regulations SOR/2018-108, laboratories have much to consider in regards to what standards and regulations impact them.

That said, consider approaching the question of regulatory compliance from the standpoint of adopting standards. Consider first that the risks and consequences of performing a task poorly drives regulation and, more preferably[48][49], standardization, which in turn moves the "goalposts" of quality and security among organizations. In the case of regulations, those organization that get caught not conforming to the necessary regulations tend to suffer negative consequences, providing some incentive for them to improve organizational processes and procedures.

One of the downsides of regulations is that they can at times be "imprecise" or "disconnected"[49] from what actually occurs within the organization and its information systems. Rather than focusing heavily on regulatory conformance, well-designed standards may, when adopted, provide a clearer path of opportunity for organizations to improve their operational culture and outcomes, particularly since standards are usually developed with a broader consensus of interested individuals with expertise in a given field.[48] In turn, the organizations that adopt well-designed standards likely have a better chance of conforming to the regulations they must, and they'll likely have more interest in maintaining and improving the goalposts of quality and security in the lab.

Additionally, reputable software developers of laboratory informatics software will not only adopt their own industry standards for software development but also understand the standards and regulations that affect food and beverage laboratories. In turn, the developed software should meet regulations and standards, help the laboratory comply with its regulations and standards, and be of reliably good quality.

If you're a potential buyer of a laboratory informatics solution, it may be that you know a bit about your laboratory's workflow and a few of the regulations and standards that influence how that workflow is conducted, but you're not entirely informed about all the regulations and standards that affect your lab. Turning to a URS such as LIMSpec—which was developed around laboratory regulations and standards—and reviewing the various statements contained within may be necessary to help further inform you. Additionally, as you investigate various informatics options, you can then use the requirements in the URS as a base for your laboratory's own requirements list. Using the categories and their subdivisions, you can then add those requirements that are unique to your laboratory and industry that are not sufficiently covered by the base URS. As you review the various options available to you and narrow down your search, your own list of requirements can be used as both as a personal checklist and as a requirements list you hand over to the vendor you query. And since your URS is based off the standards and regulations affecting your lab, you can feel more confident in your acquisition and its integration into your laboratory workflow.

3.1.5 System flexibility

Before selecting a solution, your laboratory should also have internal discussions about how diversified its offered services are, as well as what the future may bring to the lab. If, for example, your lab is currently configured for food authenticity and adulteration testing, does your existing laboratory informatics system—or the ones you may be considering—have the flexibility to add other types of food and beverage testing, protocols, and workflows? Will you be doing the footwork to add them, or will the vendor of your system support you in that effort? If you're a start-up, will your lab be focusing solely on a specific type of food testing and expand into other types of analytical work later, or will your test menu need to be much broader right from the start? In most of these cases, you'll desire a LIMS that is flexible enough to allow for not only running the specific tests you need now, but also sufficiently expandable for any future testing services your lab may conduct in the mid- and long-term. Having the ability to create and customize sample registration screens, test protocols, labels, reports, specification limit sets, measurement units, and substrates/matrices while being able to interface with practically most any instrument and software system required will go a long way towards making your expanding test menu and workflows integrates as smoothly as possible.

Such a system will typically be marketed as being highly user-configurable, giving labs a relatively painless means to adapt to rapid changes in test volume and type over time. However, once you've internally addressed current and anticipated future growth, your lab will want to learn what explicitly makes any given vendor's system user-configurable. How easy is it to configure the system to new tests? Add custom reports? What knowledge or skills will be required of your lab in order to make the necessary changes, i.e., will your staff require programming skills, or are the administrator and advanced user functions robust enough to make changes without hard-coding? These and other such questions should be fully addressed by the vendor in order to set your mind at ease towards a system's stated flexibility. Ultimately, you want the system to be flexible enough to change with the laboratory—and industry—itself, while minimizing overall costs and reducing the time required to make any necessary modifications.

3.1.6 Cost considerations

First, you'll want to be clear on what will be included in the sales agreement. Whether through an estimate or statement of work (SOW), it is important it includes exactly what is expected, being as specific as possible, since this will be the entire contractual obligation for both you the buyer and them the vendor. Note that line items may differ slightly from system to system, according to what features and functions are included by default with each vendor's solution and which, if any, are additional. Also keep in mind that any hourly amount in the the estimate or SOW is usually a best estimate; however, if sufficient attention to detailed requirements has been given, then it should be quite accurate, and in fact the final cost may even be below the quoted cost if you prioritize your own obligations so that the vendor's hours are used sparingly and efficiently.

The estimate or SOW should optimally include:

  • licensing or subscription rates;
  • required core items to meet federal, state, and local regulations;
  • additional optional items and totals; and
  • required services (implementation, maintenance and support, optional add-ons).

There are two primary ways to price a laboratory informatics solution: a one-time license fee or a subscription rate (cloud-hosted software as a service [SaaS]). If you have your own dedicated IT department and staff, you may prefer the former (although many system administrators are just as happy to let it be hosted elsewhere rather than add to their workload). Otherwise, a SaaS subscription may well be the better and more cost-effective way to go (since the primary IT cost is simply internet access). This item will be part of your up-front cost and, in the case of subscription, it will also figure into your first year and ongoing costs; otherwise only associated maintenance, support, and warranty (MSW) will figure in. Typically, your first year's subscription costs will be due at signing. More often, the vendor may require three months or even the first year up front, so be prepared to factor that into up-front costs. However, it still is almost always less expensive at the outset (and over time, if you factor in IT costs and annual MSW) than paying for a license fee.

In addition to the two types of software pricing, there are also sub-types. Generally these are based on the number of users (or, in some cases, "nodes," which are simply any entities that access the informatics system, including other systems, instruments, etc.). How these are counted can vary.

  • Named users: This method bases pricing on the actual individual users of the system, even if they only log in sporadically. Users may not use each other's logins (this is a no-no regardless of pricing structure, for good laboratory practice and other regulatory reasons).
  • Concurrent users: This bases pricing on the maximum number of users who will be logged in at any given time. You can define an unlimited number of named users in the system, each with their own login credentials. However, only the number of concurrent users specified in the license or subscription may be logged in at any one time. For example, you may have 10 staff, but due to work processes, shifts, etc., only up to six might ever be logged in simultaneously. Whereas this would require a named user license for 10, it would only require a concurrent user license for six.
  • Unlimited users: In the case of very large labs (typically 30 to 50 and up), the license or subscription may simply be a flat fee that allows any number of users.

The line items in the estimate or SOW should reflect these nuances, as well as whether the listed costs are monthly or annual (for subscription services), hourly (typically for support and training), or a fixed one-time cost. Additionally, be cautious with fixed costs, as they typically represent one of two possible scenarios:

  1. Final fixed cost: In this case, the cost has been figured by the vendor so as to cover their worst-case hourly labor total. If a line item (e.g., an interface) is not "worst case," then you are overpaying.
  2. "Expandable" fixed cost: This is as bad as final fixed cost, and maybe even worse because it's almost a case of "bait-and-switch," popping up as a surprise. The initial "fixed cost" number is low, and additional hourly services are needed to actually deliver the item. This will have been provided for somewhere in the small print.

The bottom line is that everything in a laboratory informatics solution is really either licensing or hourly services. Just be careful if they are portrayed as anything else.

It is important to be clear which category each line item falls under when figuring costs: up-front (due upon signing), annual, or ongoing (e.g., SaaS subscription). It is useful to clearly lay out each and compute initial costs, as well as first-year and subsequent years' costings. For example, your initial obligation may be as little as your first year's subscription plus the first 40 hours of services. Different vendors have different policies, however, and you may be required to pay for your first full year's subscription and all services, or some other combination. Normally, though, any instrument interface or other service charges aren't due until the they are implemented, which may be a few weeks or even a month down the road. This may depend on your budget, complexity of the SOW, and urgency. Your first year's expenses will include everything, including initial license fees; all setup and training; any interfaces and additional configurations or customization; and first annual MSW. (If this isn't included in the SaaS subscription, then it usually commences on full system delivery). Afterwards, your subscription and MSW will be the only ongoing expenses (included as one in this example), unless you choose to have additional interfaces or other services performed at any time.


3.2 Implementation

If you've ever worked through a system implementation process with a vendor, it was hopefully a smooth process. However, there are plenty of horror stories out there, highlighting the need of the laboratory to discuss in detail how a potential vendor will handle installation, validation, and training for the informatics solution. Does the vendor truly understand the industry and your needs? Does the vendor assign a project manager who will work with you, from planning to go-live and beyond? Can they offer you references of other labs who have gone through implementation so you can compare notes with those labs? How much attention does the potential vendor give to related issues such as data integrity of migrated data? Do they have the means to properly handle your legacy data? And are they able to work with your schedule, even if it means implementing software at off-peak work hours?[50][51]

As you finally get down to the ultimate decision on which vendor to work with, you may wish to start setting up an implementation checklist as part of your early project planning. Do you receive a help desk account as part of the implementation process, and if so, what information is included? If not, you'll need to keep track of specific details such as business associate agreement (BAA), sales agreement, scope documents, welcome letters, documentation, and approved staff who can utilize the vendor's support. You'll likely need to share other configuration details with the vendor, including time zone requirements, DNS and URL requirements, up-time monitors, and administrative account requirements. Finally, you'll want to ensure you and the vendor are on the same page concerning any additional customization, integration, and system validation requirements, ensuring the roll-out period is pain-free and efficient.

3.2.1 Internal and external integrations

Laboratories acquire data management software for many reasons, including improving accuracy, saving time, increasing productivity, and adding capabilities. One way of doing all of those activities is to integrate or interface your systems, databases, and instruments so that human error is greatly reduced or eliminated, workflows are automated and sped up, and each component's capabilities are brought into play in the most efficient and effective ways possible. As such, you'll want to inquire with the vendor about its solution's hardware and software integration capabilities. Is it designed to interface with every laboratory instrument or software that can output any readable electronic file? Or are integrations limited to certain instruments and systems? How does it connect, i.e., what protocols does the software depend on to connect with other systems? Does the system allow a user to map their own file imports and exports? Can system processes be set to detect new instances of file outputs at regular intervals? Ask these and other questions to make sure the vendor clearly describes what internal and external integrations are supported with their application.

In many cases, a vendor's LIMS solution will have instrument integration capability built into the software, but occasionally such interfaces are separate from the main software. Today's instrument interfaces are generally built on standardized communication protocols such as RS-232, RS-422, IEEE-488 (GPIB), USB, Ethernet, and more.[52] The LIMS that can support such instrument integrations is increasingly vital to the food and beverage laboratory. Food and beverage labs may also want their laboratory informatics solution to be able to communicate with other software and databases. This is often done using application programming interfaces (APIs) that depend on web services implementation protocols such as REST and SOAP.[53][54][55] These messaging protocols actually allow for the creation of an API that receives communication requests and sends responses between two software systems. A more practical example is wanting your laboratory informatics solution to communicate with an enterprise resource planning (ERP) application. Perhaps the ERP system needs to create sample batches within the informatics solution, and when testing is done, have the results returned to the ERP. APIs and communication protocols make this happen.[54]


3.3 MSW, updates, and other contracted services

The maintenance, support, and warranty (MSW) offered with the vendor's solution is almost as important as the solution itself. The laboratory informatics solution you acquire is more than than the software you operate: it's mission-critical and deserves having a reliable and responsive team with the necessary resources to ensure it remains operational. Downtime can negatively affect both immediate customer satisfaction and your reputation. As such, it's imperative you ask the vendor about the details of its MSW, making sure you understand what is and isn't covered, as well as how much it will cost. Cost-wise, industry norms are anywhere from 15% to 25% of either the license fee or total contract, levied annually to provide this coverage.[56] Alternatively, it may simply be included with your subscription. The MSW will include a specified number of support and maintenance hours or guarantees. The actual warranty should be unlimited for as long as the MSW or subscription is kept current.

Maintenance includes any and all work necessary to keep your system working as designed. It should include updates, patches, or fixes, and most if not all upgrades. (Note, however, a major upgrade to a totally new edition may not be covered, but it may come at a negotiable, significantly lower cost.[57]) The support aspect of MSW generally consists of a specified number of hours dedicated more to helping you with the operation of the system rather than "fixing" anything. Support includes guidance on training, password or login support, and more. Finally, with any professional application you also expect to have a warranty. The warranty should cover anything that doesn't work that otherwise should for the designated period of time.[57] That includes any standard features and functions, as well as any additional ones that were delivered and signed off on, and any other work performed by the vendor or its representatives. However, a typical warranty does not cover anything that was working fine, but upon being manipulated in a way beyond normal operation the functionality ceased. In these cases, you'll probably have to pay to get it fixed.

Beyond the MSW, additional updates and services related to the system may also be required. No matter how well it is pre-configured, any professional laboratory informatics solution will require some amount of standard setup to reflect your particular lab. This includes adding lab branding and demographics for reports and certificates; entering users, their roles, and access permissions; adding and/or modifying tests and workflows; renaming fields; adding or hiding fields; setting up a web portal; and implementing interfaces. Equally indispensable is proper training for both users and administrators. And of course you may later find that you would like additional features or functions. These and other services may prove particularly useful to the laboratory with little in the way of IT and systems expertise. As such, the vendor may provide one or more of the following as a billable service for the laboratory:

  • initial implementation meeting (e.g., initial planning, identify delta, set schedule)
  • project management
  • requirements gathering and documentation
  • initial setup
  • user and administrator training
  • configuration and customization
  • interface development and implementation
  • custom screen and field development
  • custom functionality development
  • custom reports and labels
  • custom triggers and alerts
  • validation or acceptance testing (to a third-party standard or certification, or to agreed manufacturer specs)


3.4 How a user requirements specification fits into the entire process (LIMSpec)

Merriam-Webster defines a "specification" as "a detailed precise presentation of something or of a plan or proposal for something."[58] In other words, an existing or theoretical product, concept, or idea is presented in detail for a particular audience. In a broad sense, detailing the specifics about a project, concept, or idea to others is just common sense. This applies just as well to the world of software development, where a software requirements specification is essential for preventing the second most commonly cited reason for project failure: poor requirements management.[59]

In fact, the ISO/IEC/IEEE 29148:2018 standard (a conglomeration of what was formerly IEEE 830 and other standards) is in place to help specify "the required processes implemented in the engineering activities that result in requirements for systems and software products" and provide guidelines for how to apply those requirements.[60] The standard describes the characteristics that make up quality software requirement development, including aspects such as[61]:

  • correctly describing system behavior;
  • effectively removing ambiguity from the language used;
  • completely covering the system behavior and features;
  • accurately prioritizing and ranking the requirements; and
  • unequivocally ensuring the requirements are testable, modifiable, and traceable.

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 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.

This is where a requirements specification shines, not only for the software developer but also for those acquiring the software. A set of development requirements, compiled in the form of a software requirements specification, can serve to strengthen the software development process. For those acquiring the software, a set of user requirements, compiled in the form of a user requirements specification (URS), can be used for the selection and acquisition of software or a service.[62][63] In the case of the URS, the acquiring business can approach this several ways. The simple way would be to essentially take the vendor at the word in regards to what they say their system can and can't do, agreeing formally to their description and taking responsibility that it will cover all the applicable regulations required by your business. However, this method isn't comprehensive and leaves the business open to not being able to fully meet its goals.[63]

The other method has the URS be specific to your business' needs. The process is more work but leaves less to chance.[63] Developing your own URS isn't always straightforward. Often times, the developed document turns into a mix of "wishlist" requirements from potential and active clients, as well as regulation-mandated requirements. The wishlist items aren't necessarily ignored by developers, but the URS should in fact clearly prioritize requirements as "nice to have" or "essential to system operation," or something in between.[64][65][66] Whatever the URS looks like in the end, it's ultimately up to the vendor to be able to demonstrate how the software does and does not meet its requirements.

In the latter half of this guide, you'll be given an opportunity to see an example of a URS for the food and beverage industry in the form of LIMSpec, an evolving set of software requirements specifications for laboratory informatics systems. Built from requirements found in ASTM E1578-18 Standard Guide for Laboratory Informatics, as well as dozens of other standards and regulations, we will use LIMSpec to demonstrate how a URS can be put to use, while also showing you how an informatics system can help you laboratory better meet regulatory requirements.

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