Difference between revisions of "User:Shawndouglas/sandbox/sublevel2"

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==1.5 Central and contract research lab==
==1.5 Central and contract research lab==
Medical research laboratories provide a regulated environment for the testing of the safety and efficacy of a variety of medical treatments and diagnostic devices, including medications, implants, and physician test kits. These facilities form the backbone of today's effective medical treatments, from cholesterol-lowering medications to pacemakers for the heart. In the U.S., these types of labs are overseen by the FDA. Medical research labs are found in the private, government, and academic sectors and provide many different analytical and consulting services, including (but not limited to)<ref name="MAGIDefinition04">{{cite web |url=https://www.magiworld.org/FdaGcpRecords?Pkey=1134 |title=Definition of Central Laboratory |work=FDA Good Clinical Practice (GCP) Q&A |publisher=Model Agreements & Guidelines International |date=19 April 2004 |accessdate=08 January 2020}}</ref><ref name="MinorHandbook06">{{cite web |url=https://books.google.com/books?id=RmrLBQAAQBAJ&printsec=frontcover |title=Handbook of Assay Development in Drug Discovery |editor=Minor, L.K. |publisher=CRC Press |year=2006 |pages=488 |isbn=9781420015706}}</ref>:  
Medical research laboratories provide a regulated environment for the testing of the safety and efficacy of a variety of medical treatments and diagnostic devices, including medications, implants, and physician test kits. These facilities form the backbone of today's effective medical treatments, from cholesterol-lowering medications to pacemakers for the heart. In the U.S., these types of labs are overseen by the FDA. Medical research labs provide many different analytical and consulting services, including (but not limited to)<ref name="MAGIDefinition04">{{cite web |url=https://www.magiworld.org/FdaGcpRecords?Pkey=1134 |title=Definition of Central Laboratory |work=FDA Good Clinical Practice (GCP) Q&A |publisher=Model Agreements & Guidelines International |date=19 April 2004 |accessdate=08 January 2020}}</ref><ref name="MinorHandbook06">{{cite web |url=https://books.google.com/books?id=RmrLBQAAQBAJ&printsec=frontcover |title=Handbook of Assay Development in Drug Discovery |editor=Minor, L.K. |publisher=CRC Press |year=2006 |pages=488 |isbn=9781420015706}}</ref>:  


* clinical studies
* clinical studies
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* test kit development and supply
* test kit development and supply


Medical research can happen in the private, government, and academic sectors. Private medical research labs are most often refereed to as "central laboratories" that are contracted by pharmaceutical companies and medical device manufacturers. Though mentioned occasionally in its regulation and guidance, the U.S. Food and Drug Administration doesn't seem to provide a definition of the term "central laboratory." However, it get used by some in the context of an analytical laboratory that provides analyses of biological specimens associated with clinical and bioequivalence studies (including multi-site studies, prompting the idea of a "central" lab handling sample analysis) performed at medical institutions.<ref name="MAGIDefinition04" /><ref name="KarelinSelecting13">{{cite web |url=https://www.contractpharma.com/issues/2013-05/view_features/selecting-a-central-laboratory/ |title=Selecting a Central Laboratory |author=Karelin, A.; Belotserkovskiy, M.; Khokhlova, V.; Kumar, A. |work=Contract Pharma |publisher=Rodman Media, Inc |date=06 May 2013 |accessdate=08 January 2020}}</ref> These contract labs may also provide "courier services for delivering lab kits and biosamples from/to medical institutions where diagnostics and treatment of patients is performed."<ref name="KarelinSelecting13" /> Analytical testing and other services at a central or contract lab include anatomic pathology, digital pathology, immunology, microbiology, flow cytometry, biomarker testing, pharmacokinetic testing, genomic testing, and specimen and biorepository management.<ref name="CovanceClinical">{{cite web |url=https://www.covance.com/services/clinical-testing/central-laboratory-services/core-laboratory-testing-services.html |title=Clinical Core Laboratory Testing Services |publisher=Covance, Inc |accessdate=08 January 2020}}</ref><ref name="ACMCentral">{{cite web |url=https://www.acmgloballab.com/central-lab-services |title=Central Lab Services |publisher=ACM Global Laboratories |accessdate=08 January 2020}}</ref>
Medical research can happen in the private, government, and academic sectors. Private medical research labs are most often refereed to as "central laboratories," which are contracted by pharmaceutical companies and medical device manufacturers. Though mentioned occasionally in its regulation and guidance, the U.S. Food and Drug Administration doesn't seem to provide a definition of the term "central laboratory." However, it gets used by some in the context of an analytical laboratory that provides analyses of biological specimens associated with clinical and bioequivalence studies (including multi-site studies, prompting the idea of a "central" lab handling sample analysis) performed at medical institutions.<ref name="MAGIDefinition04" /><ref name="KarelinSelecting13">{{cite web |url=https://www.contractpharma.com/issues/2013-05/view_features/selecting-a-central-laboratory/ |title=Selecting a Central Laboratory |author=Karelin, A.; Belotserkovskiy, M.; Khokhlova, V.; Kumar, A. |work=Contract Pharma |publisher=Rodman Media, Inc |date=06 May 2013 |accessdate=08 January 2020}}</ref> These central labs may also be contracted out to provide "courier services for delivering lab kits and biosamples from/to medical institutions where diagnostics and treatment of patients is performed."<ref name="KarelinSelecting13" /> Analytical testing and other services at a central or contract lab include anatomic pathology, digital pathology, immunology, microbiology, flow cytometry, biomarker testing, pharmacokinetic testing, genomic testing, and specimen and biorepository management.<ref name="CovanceClinical">{{cite web |url=https://www.covance.com/services/clinical-testing/central-laboratory-services/core-laboratory-testing-services.html |title=Clinical Core Laboratory Testing Services |publisher=Covance, Inc |accessdate=08 January 2020}}</ref><ref name="ACMCentral">{{cite web |url=https://www.acmgloballab.com/central-lab-services |title=Central Lab Services |publisher=ACM Global Laboratories |accessdate=08 January 2020}}</ref>


===1.5.1 Academic research===
===1.5.1 Medical and other research in academia===
Medical research also occurs in academia. (For convenience, this may be referred to as "academic research," a broad catch-all category for other research involving laboratories that doesn't readily fit into other industry categories.)
Medical research also occurs in academia, and they need suitably equipped and staffed laboratories for conducting studies. As such, universities may host their own central or core laboratory for both in-house<ref name="WashUCore">{{cite web |url=https://research.wustl.edu/core-facilities/core-laboratory-clinical-studies/ |title=Core Laboratory for Clinical Studies (CLCS) |work=Office of the Vice Chancellor for Research |publisher=Washington University in St. Louis |accessdate=08 January 2020}}</ref> and contract research services.<ref name="UofRClinical">{{cite web |url=https://www.urmc.rochester.edu/pathology-labs/central.aspx |title=Clinical Trials Central Laboratory Services |publisher=University of Rochester Medical Center |accessdate=08 January 2020}}</ref>


Clinical studies and trials aside, other types of academic research may require laboratory services as well. Take for example the archaeology laboratory, which is responsible for cleaning, analyzing, and identifying artifacts and remains from various sites either as part of a greater research effort or as a contract laboratory service.<ref name="AugustanaArchLab">{{cite web |url=http://www.augie.edu/archeology-laboratory |title=Archeology Laboratory |publisher=Augustana University |accessdate=08 January 2020}}</ref><ref name="SLUArchLab">{{cite web |url=https://www.slu.edu/arts-and-sciences/sociology-anthropology/labs.php |title=Lab - Archaeology Lab |publisher=Saint Louis University |accessdate=08 January 2020}}</ref> Research in information technology and communication also occurs in (dry) laboratories; examples include the privately owned Nokia Bell Laboratory<ref name="NokiaHistoryBell">{{cite web |url=https://www.bell-labs.com/about/history-bell-labs/ |title=History |publisher=Nokia Group |accessdate=08 January 2020}}</ref> and the university-affiliated University of New Hampshire InterOperability Laboratory.<ref name="UNH-IOL_FAQ">{{cite web |url=https://www.iol.unh.edu/about/faq |title=UNH-IOL FAQ |publisher=University of New Hampshire InterOperability Laboratory |accessdate=08 January 2020}}</ref>
Clinical studies and trials aside, other types of academic research may require laboratory services as well. Take for example the archaeology laboratory, which is responsible for cleaning, analyzing, and identifying artifacts and remains from various sites either as part of a greater research effort or as a contract laboratory service.<ref name="AugustanaArchLab">{{cite web |url=http://www.augie.edu/archeology-laboratory |title=Archeology Laboratory |publisher=Augustana University |accessdate=08 January 2020}}</ref><ref name="SLUArchLab">{{cite web |url=https://www.slu.edu/arts-and-sciences/sociology-anthropology/labs.php |title=Lab - Archaeology Lab |publisher=Saint Louis University |accessdate=08 January 2020}}</ref> Research in information technology and communication also occurs in (dry) laboratories; examples include the privately owned Nokia Bell Laboratory<ref name="NokiaHistoryBell">{{cite web |url=https://www.bell-labs.com/about/history-bell-labs/ |title=History |publisher=Nokia Group |accessdate=08 January 2020}}</ref> and the university-affiliated University of New Hampshire InterOperability Laboratory.<ref name="UNH-IOL_FAQ">{{cite web |url=https://www.iol.unh.edu/about/faq |title=UNH-IOL FAQ |publisher=University of New Hampshire InterOperability Laboratory |accessdate=08 January 2020}}</ref>

Revision as of 21:59, 8 January 2020

Introductory chapter text goes here

1.1 Medical diagnostics lab

Often referred to as simply a medical or clinical laboratory, the medical diagnostics lab performs tests on clinical specimens in order to get information about the health of a patient as pertaining to the diagnosis, treatment, and prevention of disease.[1] An additional definition is provided by the Clinical Laboratory Improvement Amendments (CLIA) program, as "a facility that performs testing on materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or assessment of the health of, human beings."[2]

The medical laboratory at a basic level, whether chemistry or pathology, operates like many other analytical testing laboratories. However, there are a few nuances between the medical laboratory and other analytical laboratories. One of these differences is the need to have a specific unidirectional workflow. This is intended to both minimize the risk of biohazard contamination and to establish assurance that sample cross contamination is minimized.[3][4] Another major difference concerns the regulations governing the management of patient data (e.g., the Health Insurance Portability and Accountability Act [HIPAA] in the U.S. and General Data Protection Regulation [GDPR] in Europe). This creates a significant challenge not generally experienced by other types of analytical laboratories.

In most parts of the world, the medical laboratory is either attached to a hospital, performing tests on their patients, or acts as a private (or public) laboratory that receives analysis requests and samples from physicians, insurance companies, clinical research sites, and other health clinics for analysis. In cases where a particularly specialized analysis is required and standard medical laboratory is not equipped to handle it, a research laboratory with the appropriate equipment and expertise may be employed. In other cases, a laboratory may decide it's simply more cost effective to contract more specialized, less common analyses out to specialized medical labs rather than heavily invest in the equipment and training to perform such analyses. Examples include the molecular diagnostics and cytogenetics laboratory, which provide diagnoses and treatment options for genetic or cancer-related disorders.

Like other analytical laboratories, regulations, laws, and standards typically drive how vital aspects of the laboratory operate. In the United States, clinical laboratories are primarily regulated by the Department of Health and Human Services. Inside that infrastructure are sub-entities like the Centers for Disease Control and Prevention (CDC) and the Centers for Medicare and Medicaid Services (CMS) to apply standards and regulations through their respective Laboratory Quality Assurance and Standardization Programs, and the Clinical Laboratory Improvement Amendments.[5][6][7] Although generally not as strict as the regulations regarding pharmaceutical and diagnostic manufacturers, the regulations affecting the medical laboratory nonetheless act as a significant hurdle to managing the overall operations of the laboratory, from acquiring customers and samples, to testing, reporting results, and handling billing for the completed tests.

Internationally, regulatory bodies vary from country to country. However, organizations like the not-for-profit Clinical and Laboratory Standards Institute (CLSI)[8] and associations like the Research Quality Association (RQA)[9] exist to promote a more global approach to regulations and guidance affecting medical diagnostic and research laboratories. Additionally, a set of Good Clinical Laboratory Practice standards—originally developed in 2002 and since adopted by the World Health Organisation (WHO), non-governmental organisations (NGOs), and research institutions worldwide—provide guidance on implementing laboratory practices that are critical for laboratory operations around the world.[10][11]

1.1.1 Pathology

Pathology is at the heart of a medical laboratory's operations. In the context of modern medical treatment, the laboratory practice of pathology involves analytical workflow which falls within the contemporary medical field of "general pathology" and the associated determination of the causes and effects of disease and other medical ailments. General pathology is broadly composed of a number of distinct but inter-related medical specialties that analyze tissue, cell, and body fluid samples to better understand the cause, pathogenesis, morphologic changes, and clinical manifestations of a disease.[12] In common medical practice, general pathology is mostly concerned with analyzing known clinical abnormalities that are markers or precursors for both infectious and non-infectious disease and is conducted by experts in one of two major specialties: anatomical pathology and clinical pathology. Additional subspecialties of pathology may further specialize in specific diseases (such as cancer) or situational focuses (such as cause of death).

1.1.1.1 Anatomical vs. clinical pathology

Anatomical (or "anatomic") pathology is a medical specialty of pathology that is concerned with the gross, microscopic, chemical, immunologic, and molecular examination of organs, tissues, and whole bodies (as in autopsy) to determine the presence of disease. Its subspecialties include surgical pathology (neuropathology, dermatopathology, etc.), cytopathology, and forensic pathology.[13] Clinical pathology, however, is concerned with the diagnosis of disease based on the laboratory analysis of bodily fluids such as blood, urine, and tissues using the tools of chemistry, microbiology, hematology, and molecular analysis. Its subspecialties include hematopathology, immunopathology, and molecular pathology.[13] Both anatomical and clinical pathologists work in close collaboration with clinical scientists (clinical biochemists, clinical microbiologists, etc.), medical technologists, surgeons, hospital administrators, and referring physicians to ensure the accuracy and optimal utilization of laboratory testing. Yet some argue the distinction between anatomic and clinical pathology is increasingly blurred by the introduction of molecular technologies that require new expertise and the need to provide patients and referring physicians with integrated diagnostic reports.[14][15]

Regardless, some differences between anatomical and clinical pathology remain distinct[16]:

  • Specific dictionary-driven tests are found in clinical pathology environments but not so much in anatomic pathology environments.
  • Ordered anatomic pathology tests typically require more information than clinical pathology tests.
  • A single anatomic pathology order may be comprised of several tissues from several organs; clinical pathology orders usually do not.
  • Anatomic pathology specimen collection may be a very procedural, multi-step processes, while clinical pathology specimen collection is routinely more simple.

The differences between the two may appear to be small, but a differentiation in laboratory workflow between the two is apparent, to the point that developers of laboratory information systems (LIS) and anatomic pathology computer systems used in the pathology fields have created different functionality for them. Specimen collection, receipt, and tracking; work distribution; and report generation may vary–sometimes significantly–between the two, requiring targeted functionality in the utilized software.[17][18]

1.1.1.2 Forensic pathology

Typically associated with a medical examiner or coroner, forensic pathology is focused on identifying and determining the cause of death of an individual. This includes not only the analysis of wounds and injuries but also full tissue specimens, identifying traumas—as well as chemical, biological, and solid foreign bodies and contaminates—that may have played a role in the individuals death. Anatomic pathology plays an important part of the examiner's analyses—represented by the forensic pathologist's required training—though clinical pathology also plays a role.[19] Outside the gross examination of a body, the forensic pathologist will rely on the lab to conduct a variety of analyses. Samples of from sold organs, as well as blood, urine, bile, and vitreous humor may be analyzed for toxicology, DNA typing, infectious diseases, disorders, or other chemical tests.[20] In particular, maintaining chain of custody for such samples is vital to ensure analyses are correct and evidence is not compromised. Though a medical laboratory, the forensic pathology laboratory isn't held to the same CLIA standards; they must be accredited by a related organization such as The American Society of Crime Laboratory Directors/Laboratory Accreditation Board to ensure the lab operates at prescribed standards.[20]

1.1.2 Physician office lab

The physician office lab, or POL, is a physician-, partnership-, or group-maintained laboratory that performs medical diagnostic tests or examines specimens in order to diagnose, prevent, and/or treat a disease or impairment in a patient as part of the physician practice.[21][22] The POL shows up in primary care physician offices as well as the offices of specialists like urologists, hematologists, gynecologists, and endocrinologists. In many countries like the United States, the POL is considered a clinical laboratory and is thus regulated by federal, state, and/or local laws affecting such laboratories.[22][23] In October 2019, the Centers for Medicare and Medicaid Services (CMS) reported 46% of all CLIA-approved laboratories in the United States (121,265) were physician office laboratories.[24] However, as of 2014, POLs were estimated to be processing only about nine percent of all clinical laboratory tests.[25]

Testing and reporting at a POL, at least in the U.S., is largely concentrated on the realm of waived CLIA testing. As of October 2019, 67% of the POLs in the United States were primarily running CLIA waived tests.[26] CLIA test complexity has three levels: high, moderate, and waived.[27] Waived tests are simple to perform and have a relatively low risk of an incorrect test result. Moderately complex tests include tests like provider performed microscopy (PPM), which requires the use of a microscope during the office visit. Providers that want to perform PPM tests must be qualified to do so under CLIA regulations.[27] High-complexity tests require the most regulation. These tests are the most complicated and run the highest risk of an inaccurate result, as determined during the FDA pre-market approval process. Tests may come from the manufacturer with their complexity level on them, or one can search the FDA database to determine the complexity of the test.[27]

Commonly performed tests include[28]:

  • urine analysis
  • urine pregnancy
  • blood occult
  • glucose blood
  • pathology consultation during surgery
  • crystal identification by microscope
  • sperm identification and analyses
  • bilirubin total
  • blood gasses
  • complete blood count
  • bone marrow smear
  • blood bank services
  • transfusion medicine

1.1.3 Integrative medicine lab

Dr. Ralph Snyderman, Director of the Center for Personalized Health Care at Duke University, defines integrative medicine as a process that creates and encourages "a seamless engagement by patients and caregivers in the full range of physical, psychological, social, preventive, and therapeutic factors known to be effective and necessary for the achievement of optimal health over the course of one's life."[29] This type of personalized healthcare takes a more holistic approach to the causes of illnesses, including the biological, behavioral, psychosocial, and environmental contributors.[30] Some medical laboratories such as those found within Duke Integrative Medicine[31], as well as Harvard Medical School's Contemplative Neuroscience and Integrative Medicine Laboratory[32], include an integrative medicine approach to their medical diagnostic and research activities. Laboratories associated with integrative medicine approaches are quite similar to standard medical laboratories, though, broadly speaking, they may focus more on nutritional, metabolic, and toxicity test types.[33]

1.2 Public health lab

A public health laboratory is a type of medical laboratory that serves regional, national, or in some cases global communities by providing clinical diagnostic testing, environmental testing, disease diagnosis and evaluation, emergency response support, applied research, regulation and standards recommendations, laboratory training, and other essential services to the communities they serve.[34][35][36][37]

A public health laboratory is unlike the average medical laboratory because it is "integrated into the broader public health system."[34] The public health laboratory must typically meet more stringent requirements, including adhering to not only CLIA (for labs in the United States), but also additional regulations laid out by the departments, agencies, and other regulatory bodies of local, state, and/or national governments. Finally, the private medical laboratory focuses on tests that diagnose the diseases of individuals, while the functions of the public health laboratory serve entire populations.[34][37]

A 2002 Association of Public Health Laboratories (APHL) report helped identify 11 core functions state public health laboratories in the United States should accomplish, giving clearer insight into how the average public health laboratory in most parts of the world should operate. Note that this is not a guarantee every lab will perform these tasks, but its a standard of what the lab should be responsible for doing. Those suggested 11 core functions are[38]:

  • disease prevention, control, and surveillance: provide timely and accurate analytical results for the assessment and surveillance of exposures; rapidly recognize and prevent the spread of communicable diseases; detect and identify biologic agents of significance in human disease; provide specialized tests for low-incidence, high-risk diseases;
  • integrated data management: accumulate, blend, and disseminate scientific information in support of public health programs; collect, monitor, and analyze laboratory data using national database systems; assist state epidemiologists, other laboratories, and practitioners with data needs
  • reference and specialized testing: serve as a primary reference microbiology laboratory for a wide variety of needs
  • environmental health and protection: conduct scientific analyses of potentially threatening environmental samples; detect, identify, and quantify toxic contaminants in environmental and biological specimens; provide air, water, soil, and other environmental laboratory testing services; provide environmental chemistry testing; determine the relationship between environmental hazards and human health; determine extent of a community's exposure to environmental hazards; rovide industrial hygiene/occupational health testing
  • food safety: test specimens implicated in foodborne illness outbreaks to identify causes and sources; detect, identify, and quantify toxic contaminants in food specimens; monitor radioactive contamination of water, milk, shellfish, and other foods
  • laboratory improvement and regulation: coordinate and promote quality assurance programs in other laboratories; act as a standard and leader for other laboratories; develop and oversee quality assurance and laboratory improvement programs; oversee the licensure, certification, and accreditation of other laboratories
  • policy development: assist the development of state and federal public health policy; assist in the development of standards for all health-related laboratories
  • emergency response: provide laboratory support to state and national disaster preparedness plans and environmental or health emergencies
  • public health-related research: evaluate and implement new technologies and analytical methodologies in support of public health and healthcare communities; adapt emerging technologies to public health laboratories; conduct applied studies into new and improved analytical methods and services; assist the private sector with newly marketed tests
  • training and education: sponsor training opportunities for public health laboratory staff; provide or facilitate training and workshops for laboratory staff in private and public sectors; provide training opportunities for careers in public health laboratory practice; provide continuing eduction opportunities to staff
  • partnerships and communication: develop and strengthen partnerships among state, county, and city entities public and private; emphasize the role and value of the public health laboratory to state public health programs; participate in strategic policy planning and development processes; build and strengthen diverse communication networks

1.3 Toxicology lab

Toxicology is a multidisciplinary study of the adverse effects of chemical substances on living organisms, and tangentially the diagnosis and treatment of exposures to those chemical substances. Toxicologists determine how plants, animals, and bacterial organisms are affected by agricultural chemicals, industrial chemicals, metals, vapors and gases, naturally occurring toxins, and drugs, typically caused by the absorption, distribution, metabolism, and excretion of those substances.[39] Like other fields, many subspecialties are associated with toxicology, including[39]:

  • analytical toxicology, for identifying toxicants;
  • biomedical toxicology, for identifying how toxicants case disease;
  • environmental toxicology, for evaluating the effects of environmental chemicals and contaminants;
  • forensic toxicology, for evaluating how toxicants and other chemicals caused death;
  • molecular toxicology, for the application of molecular biology to toxicity;
  • occupational toxicology, for evaluating the effects of chemical exposure in the workplace; and
  • regulatory toxicology, for applying mechanistic information from toxicology to regulations and standards development.

Similar to a medical laboratory, a toxicology laboratory may focus on diagnostics or research. Test types may vary based on the focus. For example, toxicity testing on research animals may involve testing for acute toxicity, subacute toxicity, short-term subchronic toxicity, and long-term chronic toxicity, reproductive toxicity, developmental toxicity, mutagenicity assays, irritation, allergic reaction, inhalation, and immunotoxicity.[39] However, diagnostic testing will involve testing for drugs of abuse, poisons, and heavy metals, or other toxicants. Pharmacogenetic testing may also be performed to develop dosing regiments for a specific drug.[40][41]

Toxicology laboratories in unique settings such as emergency departments of hospitals require extra consideration. For example, while toxicology testing in the emergency department is normal in regards to supporting and validating clinical findings, the testing must also take into account the legal ramifications of test results. Those results may be used in court cases, requiring strict chain-of-custody, full documentation, methodologies, and quality control results to be maintained. Additional specimens may be required by government bodies for their own testing, and as such the lab may want to add additional specimen collection to its official workflow. Additionally, personnel may need to become familiar with testimony procedures if required to testify in a criminal court case.[42]

1.4 Blood bank and transfusion lab

Blood Research- Saving Lives (8352) (9759352093).jpg

Blood banking is the organized laboratory process of ensuring donated blood or blood products are safe to use for transfusion or other medical procedures.[43][44] As part of this process, blood bank and transfusion labs will include procedures such as[43]:

  • ABO group typing (the blood type)
  • Rh typing (positive or negative antigen)
  • problematic antibody screening and removal (e.g., removing white blood cells from leukocyte-reduced blood)
  • current or past infection screening (e.g., hepatitis B and C, HIV, syphilis, West Nile)
  • T-lymphocyte irradiation
  • albumin, immune globulin, and clotting factor concentrate separation and processing

Additional considerations beyond the basic medical diagnostic lab are required at a blood banking lab. Like a medical diagnostic lab, blood banking personnel must use processes that protect them and others from biological infections (i.e., biosafety). Additionally, recipients of blood and blood products from the lab must also be protected, requiring extra procedures for screening, testing, documenting, and providing oversight. This includes screening against high-risk donors such as commercial sex workers and drug users, testing potential donors for infection diseases, documenting and reviewing (lookback of) donors and recipients, ensuring sufficient time is given for blood testing and cross-matching, and ensuring staff are appropriately trained concerning the risks to them and patients.[44] Additionally, staff are required to use a "first in, first out" or FIFO approach where stored blood and components are appropriately dated, stored according to date of expiry, and removed oldest first.[45] Blood banks have additional regulatory concerns as well, including monitoring storage temperature and expiry times for blood and blood products based on regulation. For example, in the United States, the FDA mandates through 21 CFR 610.53 dating period limitations and temperatures.[46]

1.5 Central and contract research lab

Medical research laboratories provide a regulated environment for the testing of the safety and efficacy of a variety of medical treatments and diagnostic devices, including medications, implants, and physician test kits. These facilities form the backbone of today's effective medical treatments, from cholesterol-lowering medications to pacemakers for the heart. In the U.S., these types of labs are overseen by the FDA. Medical research labs provide many different analytical and consulting services, including (but not limited to)[47][48]:

  • clinical studies
  • bioequivalence studies
  • study design and management
  • high-volume specimen testing
  • custom assay development
  • test kit development and supply

Medical research can happen in the private, government, and academic sectors. Private medical research labs are most often refereed to as "central laboratories," which are contracted by pharmaceutical companies and medical device manufacturers. Though mentioned occasionally in its regulation and guidance, the U.S. Food and Drug Administration doesn't seem to provide a definition of the term "central laboratory." However, it gets used by some in the context of an analytical laboratory that provides analyses of biological specimens associated with clinical and bioequivalence studies (including multi-site studies, prompting the idea of a "central" lab handling sample analysis) performed at medical institutions.[47][49] These central labs may also be contracted out to provide "courier services for delivering lab kits and biosamples from/to medical institutions where diagnostics and treatment of patients is performed."[49] Analytical testing and other services at a central or contract lab include anatomic pathology, digital pathology, immunology, microbiology, flow cytometry, biomarker testing, pharmacokinetic testing, genomic testing, and specimen and biorepository management.[50][51]

1.5.1 Medical and other research in academia

Medical research also occurs in academia, and they need suitably equipped and staffed laboratories for conducting studies. As such, universities may host their own central or core laboratory for both in-house[52] and contract research services.[53]

Clinical studies and trials aside, other types of academic research may require laboratory services as well. Take for example the archaeology laboratory, which is responsible for cleaning, analyzing, and identifying artifacts and remains from various sites either as part of a greater research effort or as a contract laboratory service.[54][55] Research in information technology and communication also occurs in (dry) laboratories; examples include the privately owned Nokia Bell Laboratory[56] and the university-affiliated University of New Hampshire InterOperability Laboratory.[57]

1.6 Cytogenetics lab

1.7 Genetic diagnostics lab (NGS)

References

  1. ↑ Sood, R. (2006). "Chapter 1: Laboratory". Textbook of Medical Laboratory Technology. Jaypee Brothers Publishers. pp. 01–28. ISBN 818061591X. https://books.google.com/books?id=hpNhAQAACAAJ. 
  2. ↑ "CLIA - How to Obtain a CLIA Certificate of Waiver" (PDF). Centers for Disease Control and Prevention. March 2019. https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/HowObtainCertificateofWaiver.pdf. Retrieved 03 January 2020. 
  3. ↑ Chen, B.; Gagnon, M.; Shahangian, S. et al. (12 June 2009). "Good Laboratory Practices for Molecular Genetic Testing for Heritable Diseases and Conditions". Morbidity and Mortality Weekly Report 58 (RR06): 1–29. https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5806a1.htm. Retrieved 03 January 2020. 
  4. ↑ Viana, R.V.; Wallis, C.L. (2011). "Chapter 3: Good Clinical Laboratory Practice (GCLP) for Molecular Based Tests Used in Diagnostic Laboratories". In Isin, A. (PDF). Wide Spectra of Quality Control. InTech. pp. 29–52. ISBN 9789533076836. http://www.intechopen.com/download/pdf/23728. 
  5. ↑ "HHS Organizational Chart". U.S. Department of Health & Human Services. 31 December 2019. 
  6. ↑ "Laboratory Quality Assurance and Standardization Programs". Centers for Disease Control and Prevention. 25 July 2017. https://www.cdc.gov/labstandards/. Retrieved 03 January 2020. 
  7. ↑ "Clinical Laboratory Improvement Amendments (CLIA)". Centers for Medicare and Medicaid Services. 3 December 2019. https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index. Retrieved 03 January 2019. 
  8. ↑ "About CLSI". Clinical and Laboratory Standards Institute. https://clsi.org/about/about-clsi/. Retrieved 03 January 2020. 
  9. ↑ "What is RQA?". Research Quality Association. https://www.therqa.com/about/. Retrieved 03 January 2020. 
  10. ↑ "Good Clinical Laboratory Practice (GCLP)". Research Quality Association. January 2012. https://www.therqa.com/resources/publications/booklets/good-clinical-laboratory-practice-booklet/. Retrieved 03 January 2020. 
  11. ↑ Ezzelle, J.; Rodriguez-Chavez, I.R.; Darden, J.M. et al. (2008). "Guidelines on Good Clinical Laboratory Practice - Bridging Operations between Research and Clinical Research Laboratories". Journal of Pharmaceutical and Biomedical Analysis 46 (1): 18–29. doi:10.1016/j.jpba.2007.10.010. PMC PMC2213906. PMID 18037599. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2213906. 
  12. ↑ Kumar, V.; Abbas, A.; Fausto, N.; Aster, J., ed. (2010). Robbins and Cotran Pathologic Basis of Disease, Professional Edition (8th ed.). Saunders Elsevier. ISBN 9781416031215. 
  13. ↑ 13.0 13.1 Adelman, H.C. (2009). Forensic Medicine. Infobase Publishing. pp. 3–4. ISBN 1438103816. https://books.google.com/books?id=x5FftcZOv1UC&pg=PA3. 
  14. ↑ Friedberg, R. (July 2013). "Evolving Changes in Health Care and Implications for Pathology and Laboratory Practice". 2013 Summer Anatomic Pathology Conference. Florida Society of Pathologists. https://scholarlycommons.libraryinfo.bhs.org/all_works/7637/. Retrieved 04 January 2020. "The advent of molecular pathology and molecular imaging tools only serves to further blur the distinction between anatomic and clinical pathology..." 
  15. ↑ Paxton, Anne (February 2011). "All for one—unifying CP and AP data". CAP Today. College of American Pathologists. http://www.captodayonline.com/Archives/0211/0211a_cp_ap.html. Retrieved 04 January 2020. "Traditionally, CP systems are based on discrete data elements while AP systems are based on blocks of text. But that distinction is starting to blur, because AP is moving to synoptic reporting, and that includes the creation of discrete data components as well as textual reporting" 
  16. ↑ Park, S.L.; Pantanowitz, L.; Sharma, G. et al. (2012). "Anatomic Pathology Laboratory Information Systems: A Review". Advances in Anatomic Pathology 19 (2): 81–96. doi:10.1097/PAP.0b013e318248b787. PMID 22313836. 
  17. ↑ Henricks, W.H. (9 October 2012). "LIS Basics: CP and AP LIS Design and Operations" (PDF). Pathology Informatics 2012. Archived from the original on 10 September 2015. https://web.archive.org/web/20150910050825/http://www.pathinformatics.pitt.edu/sites/default/files/2012Powerpoints/01HenricksTues.pdf. Retrieved 04 January 2020. 
  18. ↑ Clifford, L.-J. (August 2011). "The evolving LIS needs to be "everything" for today's laboratories". Medical Laboratory Observer. Endeavor Business Media, LLC. https://www.mlo-online.com/home/article/13004085/the-evolving-lis-needs-to-be-everything-for-todays-laboratories. Retrieved 04 January 2020. 
  19. ↑ Prahlow, J. (2010). "Chapter 3: Introduction to Forensic Pathology". Forensic Pathology for Police, Death Investigators, Attorneys, and Forensic Scientists. Humana Press. pp. 35–48. doi:10.1007/978-1-59745-404-9. ISBN 9781588299758. https://books.google.com/books?id=rF1WTiX0nHEC&pg=PA35. 
  20. ↑ 20.0 20.1 "The World of Forensic Laboratory Testing". Lab Tests Online. American Association for Clinical Chemistry. 3 January 2019. https://labtestsonline.org/articles/forensic-testing. Retrieved 04 January 2020. 
  21. ↑ "Chapter 16 - Laboratory Services" (PDF). Medicare Claims Processing Manual. Centers for Medicare and Medicaid Services. 3 May 2019. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c16.pdf. Retrieved 03 January 2020. 
  22. ↑ 22.0 22.1 "Physician Office Laboratory Evaluation Program (POLEP)". Wadsworth Center New York State Department of Health. https://www.wadsworth.org/regulatory/polep. Retrieved 03 January 2020. 
  23. ↑ "Physician Office Laboratories or Clinics - Frequently Asked Questions about Clinical Laboratory Licensing and Registration" (PDF). California Department of Public Health. May 2008. Archived from the original on 29 December 2016. https://web.archive.org/web/20161229143212/http://www.cdph.ca.gov/programs/lfs/Documents/POL-FAQ.pdf. Retrieved 03 January 2020. 
  24. ↑ "Laboratories by Type of Facility" (PDF). Centers for Medicare and Medicaid Services. October 2019. https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/factype.pdf. Retrieved 03 January 2020. 
  25. ↑ "How and Where IVD Will Find Growth in the Global POL Market – Part 2". Kalorama Information. November 2014. Archived from the original on 17 April 2015. https://web.archive.org/web/20150417204832/http://www.kaloramainformation.com/article/2014-11/How-and-Where-IVD-Will-Find-Growth-Global-POL-Market-%E2%80%93-Part-2. Retrieved 03 January 2020. 
  26. ↑ Centers for Medicare and Medicaid Services, Division of Laboratory Services (October 2019). "Enrollment, CLIA exempt states, and certification of accreditation by organization" (PDF). https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/statupda.pdf. Retrieved 03 January 2020. 
  27. ↑ 27.0 27.1 27.2 Centers for Disease Control and Prevention (6 August 2018). "Clinical Laboratory Improvement Amendments (CLIA): Test complexities". https://www.cdc.gov/clia/test-complexities.html. Retrieved 03 January 2020. 
  28. ↑ UnitedHealthcare Oxford (1 January 2018). "UnitedHealthcare Oxford's in-office laboratory testing and procedures list" (PDF). https://www.oxhp.com/secure/policy/in_office_laboratory_testing_and_procedures_list.pdf. Retrieved 03 January 2020. 
  29. ↑ Snyderman, R. (30 March 2011). "Integrative Medicine: A Comprehensive Approach to Personalized Care" (PDF). Scripps Clinic Green Hospital Grand Rounds. https://www.scripps.org/assets/documents/ralph_snyderman_md_03-30-11.pdf. Retrieved 04 January 2020. 
  30. ↑ "Integrative Medicine". The Bravewell Collaborative. 2015. http://www.bravewell.org/integrative_medicine/. Retrieved 04 January 2020. 
  31. ↑ "Duke Integrative Medicine". The Bravewell Collaborative. 2015. http://www.bravewell.org/current_projects/clinical_network/duke_center/. Retrieved 04 January 2020. 
  32. ↑ "Contemplative Neuroscience and Integrative Medicine (CNIM) Laboratory". David R. Vago - Brigham and Women's Hospital. Harvard Medical School. 2020. https://davidvago.bwh.harvard.edu/contemplative-neuroscience-and-integrative-medicine-cnim-laboratory/. Retrieved 04 January 2020. 
  33. ↑ Bralley, J.A.; Lord, R.S. (2008). "Chapter 1: Basic Concepts". Laboratory Evaluations for Integrative and Functional Medicine (2nd ed.). MetaMetrix Institute. pp. 1–16. ISBN 0967394945. https://books.google.com/books?id=CpXVAwgOv7sC&pg=PT11. 
  34. ↑ 34.0 34.1 34.2 Becker, S.; Perlman, E.J. (2010). "Chapter 1: An Introduction to Public Health Laboratories". In Jenkins, W.. Public Health Laboratories: Analysis, Operations, and Management. Jones & Bartlett Learning. pp. 1–14. ISBN 0763771023. https://books.google.com/books?id=6SDqL72zPRUC. 
  35. ↑ Committee on Assuring the Health of the Public in the 21st Century, Board on Health Promotion and Disease Prevention (2003). "Chapter 3: The Governmental Public Health Structure". The Future of the Public's Health in the 21st Century. National Academies Press. pp. 136–146. ISBN 0309133181. https://books.google.com/books?id=qa8XYZQprt0C. 
  36. ↑ "About Public Health Laboratories". Association of Public Health Laboratories. https://www.aphl.org/aboutAPHL/Pages/aboutphls.aspx. Retrieved 04 January 2020. 
  37. ↑ 37.0 37.1 Becker, S.J.; Blank, E.C.; Martin, R.; Skeels, M. (2005). "Chapter 27: Public Health Laboratory Administration". In Novick, L.F.; Mays, G.P.. Public Health Administration: Principles for Population-based Management. Jones & Bartlett Learning. pp. 623–627. ISBN 0763740780. https://books.google.com/books?id=bFBPMcQe6ogC. 
  38. ↑ Witt-Kushner, J.; Astles, J.R.; Ridderhof, J.C. et al. (20 September 2002). "Core Functions and Capabilities of State Public Health Laboratories". Morbidity and Mortality Weekly Report 51 (RR14): 1–8. https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5114a1.htm. Retrieved 04 January 2020. 
  39. ↑ 39.0 39.1 39.2 Eaton, D.L.; Gallagher, E.P. (2010). "Chapter 1.01 General Overview of Toxicology". In McQueen, C.A.. Comprehensive Toxicology (2nd ed.). Elsevier. pp. 1–46. ISBN 9780080468686. https://books.google.com/books?id=jzCAKsa2CpMC&pg=PA1. 
  40. ↑ "Clinical Toxicology Testing". ARUP Consult. ARUP Laboratories. December 2019. https://arupconsult.com/content/clinical-toxicology-testing. Retrieved 04 January 2020. 
  41. ↑ Sofronescu, A.G. (1 December 2018). "Purpose-driven Toxicology Services: The Key to Financial Success and Client Confidence". Clinical Laboratory News. American Association for Clinical Chemistry. https://www.aacc.org/publications/cln/articles/2018/december/purpose-driven-toxicology-services-the-key-to-financial-success-and-client-confidence. Retrieved 05 January 2020. 
  42. ↑ Magnani, B.; Kwong, T.C. (2012). "Chapter 2: Supporting the Emergency Department". In Magnani, B.; Bissell, M.G.; Kwong, T.C.; Wu, A.H.B. (PDF). Clinical Toxicology Testing: A Guide for Laboratory Professionals. College of American Pathologists. pp. 7–14. ISBN 9780983706816. http://webapps.cap.org/apps/docs/store/PUB220_Toxicol_Sample.pdf. 
  43. ↑ 43.0 43.1 "Blood Banking". Health Portal. Johns Hopkins Medicine. https://www.hopkinsmedicine.org/health/treatment-tests-and-therapies/blood-banking. Retrieved 08 January 2020. 
  44. ↑ 44.0 44.1 Curless, M.S.; Forrester, L.A.; Gavin, M.A. (2018). "Module 8. Laboratories and Blood Banks" (PDF). Infection Prevention and Control. Jhpiego Corporation. http://reprolineplus.org/system/files/resources/IPC_M8_BloodbanksLabs.pdf. Retrieved 08 January 2020. 
  45. ↑ Bedi, R.K.; Mittal, K.; Sood, T. et al. (2016). "Segregation of blood inventory: A key driver for optimum blood stock management in a resource-poor setting". International Journal of Applied and Basic Medical Research 6 (2): 119–22. doi:10.4103/2229-516X.179023. PMC PMC4830151. PMID 27127742. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4830151. 
  46. ↑ "§610.53 Dating periods for Whole Blood and blood components". Electronic Code of Federal Regulations. U.S. Government Publishing Office. 3 January 2020. https://www.ecfr.gov/cgi-bin/text-idx?SID=77f98d109b2f115d877d2e9970f1e996&mc=true&node=se21.7.610_153&rgn=div8. Retrieved 08 January 2020. 
  47. ↑ 47.0 47.1 "Definition of Central Laboratory". FDA Good Clinical Practice (GCP) Q&A. Model Agreements & Guidelines International. 19 April 2004. https://www.magiworld.org/FdaGcpRecords?Pkey=1134. Retrieved 08 January 2020. 
  48. ↑ Minor, L.K., ed. (2006). "Handbook of Assay Development in Drug Discovery". CRC Press. pp. 488. ISBN 9781420015706. https://books.google.com/books?id=RmrLBQAAQBAJ&printsec=frontcover. 
  49. ↑ 49.0 49.1 Karelin, A.; Belotserkovskiy, M.; Khokhlova, V.; Kumar, A. (6 May 2013). "Selecting a Central Laboratory". Contract Pharma. Rodman Media, Inc. https://www.contractpharma.com/issues/2013-05/view_features/selecting-a-central-laboratory/. Retrieved 08 January 2020. 
  50. ↑ "Clinical Core Laboratory Testing Services". Covance, Inc. https://www.covance.com/services/clinical-testing/central-laboratory-services/core-laboratory-testing-services.html. Retrieved 08 January 2020. 
  51. ↑ "Central Lab Services". ACM Global Laboratories. https://www.acmgloballab.com/central-lab-services. Retrieved 08 January 2020. 
  52. ↑ "Core Laboratory for Clinical Studies (CLCS)". Office of the Vice Chancellor for Research. Washington University in St. Louis. https://research.wustl.edu/core-facilities/core-laboratory-clinical-studies/. Retrieved 08 January 2020. 
  53. ↑ "Clinical Trials Central Laboratory Services". University of Rochester Medical Center. https://www.urmc.rochester.edu/pathology-labs/central.aspx. Retrieved 08 January 2020. 
  54. ↑ "Archeology Laboratory". Augustana University. http://www.augie.edu/archeology-laboratory. Retrieved 08 January 2020. 
  55. ↑ "Lab - Archaeology Lab". Saint Louis University. https://www.slu.edu/arts-and-sciences/sociology-anthropology/labs.php. Retrieved 08 January 2020. 
  56. ↑ "History". Nokia Group. https://www.bell-labs.com/about/history-bell-labs/. Retrieved 08 January 2020. 
  57. ↑ "UNH-IOL FAQ". University of New Hampshire InterOperability Laboratory. https://www.iol.unh.edu/about/faq. Retrieved 08 January 2020. 
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