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| <div align="center">-----Return to [[LII:The Comprehensive Guide to Physician Office Laboratory Setup and Operation|the beginning]] of this guide-----</div>
| | '''Title''': ''LIMS Selection Guide for Materials Testing Laboratories'' |
| <div class="nonumtoc">__TOC__</div>
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| ==5. Education, staffing, accreditation, and other considerations==
| | '''Edition''': First Edition |
| Operation of a [[physician office laboratory]] (POL) requires more than a few documented procedures and some [[Clinical Laboratory Improvement Amendments]] (CLIA)-waived test kits. Even the CLIA-waived POL has to meet CLIA, [[HIPAA]], and other regulations, while maintaining a respectable level of quality. As such, expertise in developing, running, and maintaining the lab is important, just like any other laboratory. But how should the POL be staffed, and what sort of education requirements should the staff have? This chapter briefly addresses those questions and also provides numerous other resources for both acquiring the necessary education towards medical laboratory science or technology and staffing your POL.
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| | '''Author for citation''': Shawn E. Douglas |
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| ===5.1 Education and training===
| | '''License for content''': [https://creativecommons.org/licenses/by-sa/4.0/ Creative Commons Attribution-ShareAlike 4.0 International] |
| [[File:Education and Training.jpg|right|400px]]Subpart M of 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. As the American Association for Clinical Chemistry (AACC) notes in a 2021 advocacy letter, proper training of personnel conducting CLIA-waived tests is broadly found to be lacking, and when paired with high turnover of lab techs in waived testing site, this often leads to inconsistent quality throughout the enterprise.<ref name="AACCModern21">{{cite web |url=https://www.aacc.org/advocacy-and-outreach/position-statements/2021/modernization-of-clia-certificate-of-waiver |title=Modernization of CLIA: Certificate of Waiver Testing Sites |publisher=American Association for Clinical Chemistry |date=25 October 2021 |accessdate=30 May 2022}}</ref> Thus, despite most tests being waived, it's important for the POL to take operator training and competency seriously, engage in regular quality assessments, and participate in an accredited proficiency testing program to mitigate poor patient outcomes.<ref name="AACCModern21" />
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| 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]. If your POL is going to engage in testing beyond CLIA-waived testing, reviewing what Subpart M means for your lab is important:
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| * [https://www.aafp.org/family-physician/practice-and-career/managing-your-practice/clia/personnel-requirements.html American Academy of Family Physicians - Personnel Requirements]
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| * [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]
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| * [http://www.labflorida.com/internal/COLA/guides/LabGuide4.pdf Commission on Office Laboratory Accreditation (COLA) - Personnel for Non-waived Testing] (PDF)
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| * [https://www.lighthouselabservices.com/state-license/ Lighthouse Lab Services - Laboratory State License and Personnel & Facility License Info]
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| 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>:
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| * California: [https://www.cdph.ca.gov/Programs/OSPHLD/LFS/Pages/AboutUs.aspx Department of Public Health - Laboratory Field Services]
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| * Connecticut: [https://portal.ct.gov/DPH/Communications/Regulation--Licensure/Regulation--Licensure Department of Public Health - Regulation & Licensure]
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| * 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]
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| * Georgia: [https://dch.georgia.gov/divisionsoffices/healthcare-facility-regulation Georgia Department of Community Health - Healthcare Facility Regulation]
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| * Hawaii: [https://health.hawaii.gov/statelab/ Department of Health - State Laboratories Division]
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| * Louisiana: [https://www.lsbme.la.gov/licensure/clinical-laboratory-personnel State Board of Medical Examiners - Clinical Laboratory Personnel]
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| * Montana: [https://boards.bsd.dli.mt.gov/clinical-laboratory-science-practitioners/ Department of Labor and Industry - Montana Board of Clinical Laboratory Science Practitioners]
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| * Nevada: [https://dpbh.nv.gov/Reg/MedicalLabs/Medical_Laboratories_-_Home/ Nevada Division of Public and Behavioral Health - Medical Laboratory Services]
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| * New Hampshire: [https://www.dhhs.nh.gov/doing-business-dhhs/licensing-certification/health-facilities-administration Department of Health and Human Services - Health Facilities Administration]
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| * New Jersey: [https://www.nj.gov/health/phel/ Department of Health - Public Health and Environmental Laboratories]
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| * 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]
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| * North Dakota: [https://www.ndclinlab.com/ North Dakota Board of Clinical Laboratory Practice]
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| * Rhode Island: [https://health.ri.gov/licenses/detail.php?id=210 Department of Health - Healthcare Licensing]
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| * Tennessee: [https://www.tn.gov/health/health-program-areas/health-professional-boards/medlab-board/ml-board/licensure.html Department of Health - Medical Laboratory Board]
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| * Washington: [https://doh.wa.gov/licenses-permits-and-certificates/facilities-z/laboratory-quality-assurance Department of Health - Laboratory Quality Assurance]
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| * West Virginia: [https://dhhr.wv.gov/healthprep/programs/laboratory/Pages/default.aspx Department of Health and Human Resources - Office of Laboratory Services]
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| As always, it remains your lab's responsibility to ensure that not only the necessary federal regulations are being followed but also state regulations and any accreditation standards are being met. For the POL short on knowledgeable staff, this may be a daunting task, requiring outside help. The final section of this guide includes additional resources for the POL, including a representative list of consultants who advertise working in the POL space.
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| ===5.2 Educational programs===
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| The following section offers a tabular listing of known U.S. and Canadian higher-education and hospital-based programs that offer an associate's, bachelor's, and/or master's program in medical laboratory technology, medical laboratory science, or some other flavor of laboratory medicine. Many of the programs offered give students a path of progression from an associate's degree in medical laboratory technology to a bachelor's degree in medical laboratory science. Additionally, some programs allow hands-on post-bachelor's training that leads to a certificate and the right to take the [https://ascp.org/content/board-of-certification ASCP Board of Certification] Medical Laboratory Scientist exam. As such, students with bachelor's degrees in relevant fields such as biology, microbiology, genetics, etc. may relatively easily become certified for laboratory work in roughly a year or less.
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| ====5.2.1 Higher-education====
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| ''Note'': This table loads in a collapsed state. Click the "Expand" link to view more.
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| {{Laboratory science education programs}}
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| ====5.2.2 One-year hospital-based programs====
| | '''Publication date''': ??? 2023 |
| ''Note'': This table loads in a collapsed state. Click the "Expand" link to view more. | |
| {{Laboratory science education programs/Hospital programs}}
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| ====5.2.3 Continuing education====
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| Continuing education is another important aspect of professional development for those working in the POL. The following are examples of entities providing continuing education opportunities related to laboratory testing.
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| * [https://www.aama-ntl.org/continuing-education AAMA's various online courses]: The American Association of Medical Assistants offers courses and continuing education opportunities.
| | Description goes here... |
| * [https://www.aruplab.com/education ARUP Institute for Learning]: "The ARUP Institute for Learning provides reputable educational opportunities and resources to ARUP clients, laboratory professionals, and industry organizations in an effort to advance the practice of laboratory medicine and continually improve patient care."
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| * [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."
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| * [https://clsi.org/global-training/earn-ce-credits/ Clinical and Laboratory Standards Institute]: "CLSI is an approved provider of CE programs in the clinical laboratory sciences by the American Society for Clinical Laboratory Science (ASCLS) P.A.C.E.® Program. In some instances, we will also provide education through the American Association of Clinical Chemistry (AACC) ACCENT® credit program."
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| * [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.
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| * [https://michener.ca/continuing-education/ce-courses/medical-laboratory-science/ Michener Institute of Education at UHN]: "Competency profiles and changes to scope of practice can occur rapidly as health sciences and technologies advance. Are you ready? The self-directed courses in Medical Laboratory Sciences below are offered with the flexibility to be completed at your pace and offer you the ability to stay up-to-date with practice."
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| '''Other courses''' | | The table of contents for ''LIMS Selection Guide for Materials Testing Laboratories'' is as follows: |
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| The [[Centers for Medicare and Medicaid Services]] (CMS) 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.
| | :[[User:Shawndouglas/sandbox/sublevel10|1. Introduction to materials and materials testing laboratories]] |
| | ::1.1 Materials testing labs, then and now |
| | :::1.1.1 Materials testing 2.0 |
| | ::1.2 Industries, products, and raw materials |
| | ::1.3 Laboratory roles and activities in the industry |
| | :::1.3.1 R&D roles and activities |
| | :::1.3.2 Pre-manufacturing and manufacturing roles and activities |
| | :::1.3.3 Post-production quality control and regulatory roles and activities |
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| | :[[User:Shawndouglas/sandbox/sublevel11|2. Standards, regulations, and test methods affecting materials testing labs]] |
| | ::2.1 Globally recognized materials manufacturing standards |
| | :::2.1.1 American Society of Civil Engineers (ASCE) materials standards |
| | :::2.1.2 ASTM International Volume 15.04 |
| | :::2.1.3 Canadian Standards Association (CSA) A3000 series |
| | :::2.1.4 International Organization for Standardization (ISO) 10993 |
| | :::2.1.5 Metal Powder Industries Federation (MPIF) Standard 35 family |
| | ::2.2 Regulations and laws around the world |
| | :::2.2.1 21 CFR Part 175 and 176 - United States |
| | :::2.2.2 Building Standard Law - Japan |
| | :::2.2.3 The Furniture and Furnishings (Fire) (Safety) Regulations 1988 - United Kingdom |
| | :::2.2.4 National Environment Protection (Used Packaging Materials) Measure 2011 - Australia |
| | :::2.2.5 Surface Coating Materials Regulations (SOR/2016-193) - Canada |
| | ::2.3 Standardized test methods for materials |
| | ::2.4 Materials laboratory accreditation |
| | :::2.4.1 A note about engineering and construction materials testing |
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| ===5.3 Certification and accreditation===
| | :[[User:Shawndouglas/sandbox/sublevel12|3. Choosing laboratory informatics software for your materials testing lab]] |
| Like other types of laboratories, certification and accreditation in clinical labs is important to ensuring quality outcomes for both patients and the lab. The following subsection details certification and accreditation options for both individuals and laboratories themselves. These programs not only allows an individual or lab to demonstrate their expertise, but they also may be required by various entities.
| | ::3.1 Evaluation and selection |
| | :::3.1.1 Technology considerations |
| | ::::3.1.1.1 Laboratory informatics options |
| | :::3.1.2 Features and functions |
| | ::::3.1.2.1 Base features |
| | ::::3.1.2.2 Specialty features |
| | :::3.1.3 Cybersecurity considerations |
| | :::3.1.4 Regulatory compliance considerations |
| | :::3.1.5 System flexibility |
| | :::3.1.6 Cost considerations |
| | ::3.2 Implementation |
| | :::3.2.1 Internal and external integrations |
| | ::3.3 MSW, updates, and other contracted services |
| | ::3.4 How a user requirements specification fits into the entire process (LIMSpec) |
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| ====5.3.1 Individual certification and accreditation programs====
| | :[[User:Shawndouglas/sandbox/sublevel13|4. Resources for selecting and implementing informatics solutions]] |
| * [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).
| | ::4.1 LIMS vendors |
| * [https://www.aab.org/aab/Application-Fees.asp American Board of Bioanalysts]: ABB offers several laboratory director certifications.
| | ::4.2 Consultants |
| * [https://www.ashi-hla.org/page/ACHI American College of Histocompatibility and Immunogenetics]: The ACHI provides certifications for histocompatability technologists and directors.
| | ::4.3 Professional |
| * [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).
| | :::4.3.1 Trade organizations |
| * [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.
| | :::4.3.2 Conferences and trade shows |
| * [https://www.ncctinc.com/certifications National Commission of Certifying Agencies]: The NCCT offers several certifications, including medical assistant (NCMA) and phlebotomy technician (NCPT).
| | ::4.4 LIMSpec |
| * [https://www.nhanow.com/certification National Healthcareer Association]: The NHA offers several certifications, including clinical medical assistant (CCMA) and phlebotomy technician (CPT).
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| * [https://www.nationalphlebotomy.org/ National Phlebotomy Association]: The NPA offers a certification for phlebotomists.
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| ====5.3.2 Laboratory accreditation programs====
| | :[[User:Shawndouglas/sandbox/sublevel14|5. Taking the next step]] |
| * [https://a2la.org/accreditation/clinical-testing/ A2LA]: "Accredits clinical laboratories to five comprehensive accreditation program"
| | ::5.1 Conduct initial research into a specification document tailored to your lab's needs |
| * [https://www.aabb.org/standards-accreditation/accreditation Association for the Advancement of Blood & Biotherapies]: AABB has an accreditation program for blood and biobanking facilities.
| | ::5.2 Issue some of the specification as part of a request for information (RFI) |
| * [https://www.cola.org/ COLA]: Formerly the Commission on Office Laboratory Accreditation; a non-profit accreditor of medical laboratories
| | ::5.3 Respond to or open dialogue with vendors |
| * [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."
| | :::5.3.1 The value of demonstrations |
| * [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
| | ::5.4 Finalize the requirements specification and choose a vendor |
| * [http://www.naacls.org/accreditation/ National Accrediting Agency for Clinical Laboratory Sciences]: The NAACLS accredits and approved educational programs in the clinical laboratory sciences.
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| ===5.4 Other considerations for the POL===
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| [[File:LabEqx–test tube.svg|right|250px]]Before closing out this guide, a few odds and ends remain in regards to the POL.
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| Though it has been hinted at throughout the guide, it should be explicitly stated that the POL running CLIA-waived testing is not exempt from professional, standardized conduct simply because it is only performing "simple tests with a low risk for an incorrect result."<ref name="CDCTestCom">{{cite web |url=https://www.cdc.gov/clia/test-complexities.html |title=Clinical Laboratory Improvement Amendments (CLIA): Test complexities |author=Centers for Disease Control and Prevention |date=06 August 2018 |accessdate=31 May 2022}}</ref> This is best highlighted by the AACC advocacy letter mentioned at the beginning of this chapter. POLs and other CLIA-waived labs "are not subject to CLIA personnel, quality control (QC), and proficiency testing (PT) requirements, nor do they undergo regular inspections," they note.<ref name="AACCModern21" /> They add that these types of labs have been documented by CMS as having numerous deficiencies, including not properly maintaining manufacturer's instructions for test kits, improperly performing [[quality control]], not reporting patient test results correctly, and not handling and storing reagents properly.<ref name="AACCModern21" /> The AACC also suggests several guidance documents for these types of labs to better avoid these deficiencies, including the [[Centers for Disease Control and Prevention]]'s (CDC's) 2015 guidance ''To Test or Not to Test? Considerations for Waived Testing''. The introduction of that guide highlights the AACC's point: "Although some of the recommendations in this booklet exceed CLIA requirements for waived testing, following these good testing practices will likely lead to reliable, high-quality test results and will enhance patient safety."<ref name="CDCToTest15">{{cite web |url=https://www.cdc.gov/labquality/docs/waived-tests/15_255581-test-or-not-test-booklet.pdf |format=PDF |title=To Test or Not to Test? Considerations for Waived Testing |author=Centers for Disease Control and Prevention |publisher=Centers for Disease Control and Prevention |date=July 2015 |accessdate=31 May 2022}}</ref>
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| Both the AACC and the CDC highlight several additional considerations for POLs seeking to provide quality services<ref name="AACCModern21" /><ref name="CDCToTest15" />:
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| * Develop, distribute, review, and curate a "best practices" document (or collection of documents) that, among other things, examines the instruments and tests used, common sources of error, and troubleshooting methods for them. This usually comes in the form of a policies and procedures manual, which is highly encouraged, though it can also be a stand-alone document.
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| * Encourage continuing education and certification in using the current and future instruments and tests used in the lab, and document that training.
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| * Ensure policy and procedure manuals document test and reagent preparation, test performance, quality control procedures, result interpretation, result reporting, test referrals, training processes, environmental monitoring, inventory management, equipment and instrument maintenance, hazardous waste management, sterilization and disinfection, protective equipment, workspace assessments, and incident reporting.
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| * Ensure that for any point-of-care and other waived tests, the manufacturer's instructions are available in the testing area, any changes to instructions are reflected in updated procedures and training, and any old versions are removed from the manual/testing space/etc.
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| * Hold the lab to a high, yet realistically maintainable, level of standards through regular internal and/or external quality assessment and corrective action activities.
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| * Have the lab participate in an official proficiency testing program that documents quality and reliability of test results.
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| * Recognize that quality and responsibility for quality must start with management that embraces and promotes good laboratory practices.
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| * Recognize that safety is just as important in a CLIA-waived lab and develop a site-specific safety plan that describes health hazards involved in testing and how to prevent them.
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| The CDC's ''[https://www.cdc.gov/labquality/docs/waived-tests/15_255581-test-or-not-test-booklet.pdf To Test or Not to Test?]'' document also contains many example documents and forms that relate to the above considerations; your POL may find them useful.
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| ==References==
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| {{Reflist|colwidth=30em}}
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| ==Citation information for this chapter==
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| '''Chapter''': 5. Education, staffing, accreditation, and other considerations
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| '''Title''': ''The Comprehensive Guide to Physician Office Laboratory Setup and Operation''
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| '''Author for citation''': Shawn E. Douglas
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| '''License for content''': [https://creativecommons.org/licenses/by-sa/4.0/ Creative Commons Attribution-ShareAlike 4.0 International]
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| '''Publication date''': June 2022
| | :[[User:Shawndouglas/sandbox/sublevel15|6. Closing remarks]] |
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| <!--Place all category tags here-->
| | :[[User:Shawndouglas/sandbox/sublevel16|Appendix 1. Blank LIMSpec template for manufacturing labs]] |
| | ::A1. Introduction and methodology |
| | ::A2. Primary laboratory workflow |
| | ::A3. Maintaining laboratory workflow and operations |
| | ::A4. Specialty laboratory functions |
| | ::A5. Technology and performance improvements |
| | ::A6. Security and integrity of systems and operations |
| | ::A7. Putting those requirements to practical use and caveats |
| | ::A8. LIMSpec in Microsoft Word format |
