Medical laboratory
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A medical laboratory or clinical laboratory is a
Medical laboratories vary in size and complexity and so offer a variety of testing services. More comprehensive services can be found in acute-care hospitals and medical centers, where 70% of clinical decisions are based on laboratory testing.[2] Doctors offices and clinics, as well as skilled nursing and long-term care facilities, may have laboratories that provide more basic testing services. Commercial medical laboratories operate as independent businesses and provide testing that is otherwise not provided in other settings due to low test volume or complexity.[3]
Departments
In hospitals and other patient-care settings, laboratory medicine is provided by the Department of Pathology and Medical Laboratory, and generally divided into two sections, each of which will be subdivided into multiple specialty areas.[4] The two sections are:
- electron microscopy, and gross pathology.
- Medical Laboratory, which typically includes the following areas:[5]
- Clinical microbiology: This encompasses several different sciences, including bacteriology, virology, parasitology, immunology, and mycology.[6]
- Hematology: This area includes automated and manual analysis of blood cells. It also often includes coagulation.[8]
- Blood bank involves the testing of blood specimens in order to provide blood transfusion and related services.[9]
- Molecular diagnostics DNA testing may be done here, along with a subspecialty known as cytogenetics.[10]
- Reproductive biology testing is available in some laboratories, including Semen analysis, Sperm bank and assisted reproductive technology.
Layouts of clinical laboratories in health institutions vary greatly from one facility to another. For instance, some health facilities have a single laboratory for the microbiology section, while others have a separate lab for each specialty area.
The following is an example of a typical breakdown of the responsibilities of each area:
- cultures, to look for suspected pathogens which, if found, are further identified based on biochemical tests. Also, sensitivity testing is carried out to determine whether the pathogen is sensitive or resistant to a suggested medicine. Results are reported with the identified organism(s) and the type and amount of drug(s) that should be prescribed for the patient.
- parasites. For example, fecal samples may be examined for evidence of intestinal parasites such as tapeworms or hookworms.
- Virology is concerned with identification of viruses in specimens such as blood, urine, and cerebrospinal fluid.
- blood films. Other specialized tests include cell counts on various bodily fluids.
- Coagulation testing determines various blood clotting times, coagulation factors, and platelet function.
- .
- Toxicology is mainly focused on testing for pharmaceutical and recreational drugs. Urine and blood samples are the common specimens.
- Immunology/Serology uses the process of antigen-antibody interaction as a diagnostic tool. Compatibility of transplanted organs may also be determined with these methods.
- blood groups, and performs compatibility testing on donor blood and recipients. It also prepares blood components, derivatives, and products for transfusion. This area determines a patient's blood type and Rh status, checks for antibodies to common antigens found on red blood cells, and cross matches units that are negative for the antigen.
- clinical biochemistrylab.
- biopsies) for evaluation at the microscopic level.
- Cytopathology examines smears of cells from all over the body (such as from the cervix) for evidence of inflammation, cancer, and other conditions.
- Molecular diagnostics includes specialized tests involving DNA and RNA analysis.
- Down's syndrome) as well as in some cancers which can be identified by the presence of abnormal chromosomes.
- Surgical pathology examines organs, limbs, tumors, fetuses, and other tissues biopsied in surgery such as breast mastectomies.
Medical laboratory staff
The staff of clinical laboratories may include:
- Pathologist
- Clinical biochemist
- Laboratory assistant (LA)
- Laboratory manager
- Medical laboratory technologistin Canada
- Medical laboratory technician/clinical laboratory technician (MLT or CLT in US)[11][12]
- Medical laboratory assistant(MLA)
- Phlebotomist(PBT)
- Histology technician
Labor shortages
The United States has a documented shortage of working laboratory professionals. For example, as of 2016[update] vacancy rates for Medical Laboratory Scientists ranged from 5% to 9% for various departments. The decline is primarily due to retirements, and to at-capacity educational programs that cannot expand which limits the number of new graduates. Professional organizations and some state educational systems are responding by developing ways to promote the lab professions in an effort to combat this shortage. In addition, the vacancy rates for the MLS were tested again in 2018. The percentage range for the various departments has developed a broader range of 4% to as high as 13%.[13] The higher numbers were seen in the Phlebotomy and Immunology.[13] Microbiology was another department that has had a struggle with vacancies.[13] Their average in the 2018 survey was around 10-11% vacancy rate across the United States.[13] Recruitment campaigns, funding for college programs, and better salaries for the laboratory workers are a few ways they are focusing to decrease the vacancy rate.[14] The National Center For Workforce Analysis has estimated that by 2025 there will be a 24% increase in demand for lab professionals.[15][16] Highlighted by the COVID-19 pandemic, work is being done to address this shortage including bringing pathology and laboratory medicine into the conversation surrounding access to healthcare.[17] COVID-19 brought the laboratory to the attention of the government and the media, thus giving opportunity for the staffing shortages as well as the resource challenges to be heard and dealt with.[18]
Types of laboratory
The examples and perspective in this article deal primarily with the United Kingdom and do not represent a worldwide view of the subject. (May 2016) |
In most developed countries, there are two main types of lab processing the majority of medical specimens. Hospital laboratories are attached to a hospital, and perform tests on their patients. Private (or community) laboratories receive samples from general practitioners, insurance companies, clinical research sites and other health clinics for analysis. For extremely specialised tests, samples may go to a research laboratory. Some tests involve specimens sent between different labs for uncommon tests. For example, in some cases it may be more cost effective if a particular laboratory specializes in a less common tests, receiving specimens (and payment) from other labs, while sending other specimens to other labs for those tests they do not perform.
In many countries there are specialized types of medical laboratories according to the types of investigations carried out. Organisations that provide blood products for transfusion to hospitals, such as the Red Cross, will provide access to their reference laboratory for their customers. Some laboratories specialize in Molecular diagnostic and cytogenetic testing, in order to provide information regarding diagnosis and treatment of genetic or cancer-related disorders.
Specimen processing and work flow
In a hospital setting, sample processing will usually start with a set of samples arriving with a test request, either on a form or electronically via the laboratory information system (
Once the specimens are assigned a laboratory number by the LIS, a sticker is typically printed that can be placed on the tubes or specimen containers. This label has a barcode that can be scanned by automated analyzers and test requests uploaded to the analyzer from the LIS.
Specimens are prepared for analysis in various ways. For example, chemistry samples are usually centrifuged and the serum or plasma is separated and tested. If the specimen needs to go on more than one analyzer, it can be divided into separate tubes.
Many specimens end up in one or more sophisticated automated analysers, that process a fraction of the sample to return one or more test results. Some laboratories use robotic sample handlers (Laboratory automation) to optimize the workflow and reduce the risk of contamination from sample handling by the staff.
The work flow in a hospital laboratory is usually heaviest from 2:00 am to 10:00 am. Nurses and doctors generally have their patients tested at least once a day with common tests such as complete blood counts and chemistry profiles. These orders are typically drawn during a morning run by
Laboratory informatics
The large amount of information processed in laboratories is managed by a system of software programs, computers, and
These systems enable hospitals and labs to order the correct test requests for each patient, keep track of individual patient and specimen histories, and help guarantee a better quality of results. Results are made available to care providers electronically or by printed hard copies for patient charts.
Result analysis, validation and interpretation
According to various regulations, such as the international ISO 15189 norm, all pathological laboratory results must be verified by a competent professional. In some countries, staffs composed of clinical scientists do the majority of this work inside the laboratory with certain abnormal results referred to the relevant pathologist. Doctor Clinical Laboratory scientists have the responsibility for limited interpretation of testing results in their discipline in many countries. Interpretation of results can be assisted by some software in order to validate normal or non-modified results.
In other testing areas, only professional medical staff (
Medical Laboratory Departments in some countries are exclusively directed by a specialized Doctor laboratory Science. In others, a consultant, medical or non-medical, may be the head the department. In Europe and some other countries, Clinical Scientists with a Masters level education may be qualified to head the department. Others may have a PhD and can have an exit qualification equivalent to medical staff (e.g., FRCPath in the UK).
In France, only medical staff (
) can discuss Laboratory results.Medical laboratory accreditation
Credibility of medical laboratories is paramount to the health and safety of the patients relying on the testing services provided by these labs. Credentialing agencies vary by country. The international standard in use today for the accreditation of medical laboratories is ISO 15189 - Medical laboratories - Requirements for quality and competence.
In the United States, billions of dollars is spent on unaccredited lab tests, such as
The accrediting body in Australia is NATA, where all laboratories must be NATA accredited to receive payment from Medicare.
In France the accrediting body is the Comité français d'accréditation (COFRAC). In 2010, modification of legislation established ISO 15189 accreditation as an obligation for all clinical laboratories.[20]
In the United Arab Emirates, the Dubai Accreditation Department (DAC) is the accreditation body that is internationally recognised[21] by the International Laboratory Accreditation Cooperation (ILAC) for many facilities and groups, including Medical Laboratories, Testing and Calibration Laboratories, and Inspection Bodies.
In Hong Kong, the accrediting body is Hong Kong Accreditation Service (HKAS). On 16 February 2004, HKAS launched its medical testing accreditation programme.
In Canada, laboratory accreditation is not mandatory, but is becoming more and more popular. Accreditation Canada (AC) is the national reference. Different provincial oversight bodies mandate laboratories in EQA participations like LSPQ (Quebec), IQMH (Ontario) for example.
Industry
The laboratory industry is a part of the broader healthcare and health technology industry. Companies exist at various levels, including clinical laboratory services, suppliers of instrumentation equipment and consumable materials, and suppliers and developers of diagnostic tests themselves (often by biotechnology companies).[22]
Clinical laboratory services includes large
Clinical laboratories are supplied by other multinational companies which focus on materials and equipment, which can be used for both scientific research and medical testing. The largest of these is Thermo Fisher Scientific.[27] In 2016, global life sciences instrumentation sales were around $47 billion, not including consumables, software, and services.[27] In general, laboratory equipment includes lab centrifuges, transfection solutions, water purification systems, extraction techniques, gas generators, concentrators and evaporators, fume hoods, incubators, biological safety cabinets, bioreactors and fermenters, microwave-assisted chemistry, lab washers, and shakers and stirrers.[28]
United States
In the United States, estimated total revenue as of 2016 was $75 billion, about 2% of total
Due to the rise of high-deductible health plans, laboratories have sometimes struggled to collect when billing patients; consequently, some laboratories have shifted to become more "consumer-focused".[33]
See also
References
- ISBN 978-1-56370-961-6.
- ^ "Hospital Labs: Behind the Scenes". U.S. News & World Report. 2015-01-30. Archived from the original on 2018-06-12. Retrieved 2018-06-07.
- ^ "What is a Medical Laboratory Science Professional?". www.ascls.org. Archived from the original on 2021-04-13. Retrieved 2018-05-31.
- ^ "Laboratory Departments". malse.org. Archived from the original on 2018-08-08. Retrieved 2018-05-30.
- ^ "What is Clinical Pathology?". csu-cvmbs.colostate.edu. Archived from the original on 2018-10-03. Retrieved 2018-10-03.
- PMC 3185854.
- ^ "Clinical Chemistry Tests - MeSH - NCBI". www.ncbi.nlm.nih.gov. Archived from the original on 2022-06-09. Retrieved 2018-10-19.
- ^ "Hematology > Laboratory Medicine - Yale School of Medicine". medicine.yale.edu. Archived from the original on 2017-04-02. Retrieved 2018-10-03.
- PMID 22379287.
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- ^ "Clinical Laboratory Technologists and Technicians : Occupational Outlook Handbook: : U.S. Bureau of Labor Statistics". www.bls.gov. Archived from the original on 2023-04-26. Retrieved 2023-04-26.
- ^ "Medical Laboratory Technician Career Overview". alliedhealthcareer.com. Archived from the original on 2023-01-11. Retrieved 2023-05-30.
- ^ PMID 31135889.
- ^ https://academic.oup.com/ajcp/article/152/2/155/5499263. Retrieved 2021-09-21.
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(help) - ^ "Medical Laboratory Professionals: Who's Who in the Lab - Lab Tests Online". labtestsonline.org. 29 April 2021. Archived from the original on 21 September 2018. Retrieved 21 September 2018.
- ^ "Laboratory Personnel Shortages - Laboratory Manager". laboratory-manager.advanceweb.com. 2016-12-05. Archived from the original on 2018-09-21. Retrieved 2018-09-21.
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- ^ Nielsen, Christine (2020). "Speaking Up for the Medical Laboratory". Canadian Journal of Medical Laboratory Science. 82: 4.
- ^ "U.S. IVD & LDT for Autoimmune Diseases Market Worth $4,745.4 Million by 2024". Archived from the original on 2017-07-06. Retrieved 2019-05-22.
- ^ "Ordonnance n° 2010-49 du 13 janvier 2010 relative à la biologie médicale | Legifrance". Archived from the original on 2019-01-23. Retrieved 2018-10-19.
- ^ "International Laboratory Accreditation Cooperation - ILAC". Archived from the original on 2014-10-25. Retrieved 2014-10-12.
- ^ Morel, Chantal; McClure, Lindsay; Edwards, Suzanne; Goodfellow, Victoria; Sandberg, Dale; Thomas, Joseph; Mossialos, Elias (2016). Overview of the diagnostics market. European Observatory on Health Systems and Policies. Archived from the original on 2020-03-08. Retrieved 2018-12-02.
- ^ a b "Industry Flash Report – Laboratory Services" (PDF). www.kaufmanhall.com. KaufmanHall. Archived (PDF) from the original on 2018-12-02. Retrieved 2018-12-01.
- ^ a b "Hospitals can save by outsourcing lab services, but quality, service are issues to be considered". Modern Healthcare. Archived from the original on 2014-10-16. Retrieved 2018-12-02.
- ^ "Clinical Laboratory Services Market Size is Projected to be Around US$ 146 Billion by 2024". MarketWatch. Archived from the original on 2018-12-02. Retrieved 2018-12-02.
- ^ "Global Clinical Laboratory Services Market Growing With 7.1% CAGR by 2023 – Leading Players are Spectra Laboratories, Sonic Healthcare Ltd., Siemens, Quest Diagnostics, Qiagen and More |". Medgadget. 2018-04-12. Archived from the original on 2018-12-02. Retrieved 2018-12-02.
- ^ a b Thayer, Ann M. "Top instrument firms in 2016 | March 6, 2017 Issue - Vol. 95 Issue 10 | Chemical & Engineering News". cen.acs.org. Archived from the original on 2018-12-02. Retrieved 2018-12-02.
- ^ "The 2017 Market for Laboratory Equipment". bioinfoinc.com. Bioinformatics. 17 February 2017. Archived from the original on 2 December 2018. Retrieved 2 December 2018.
- ^ "Fresh options fuel lab asset reshuffle". CAP TODAY. Archived from the original on 2018-12-02. Retrieved 2018-12-02.
- ^ "Rural Hospital Spokesman: Hospital Lab Outreach Programs Are Legal - The Dark Intelligence Group". www.darkintelligencegroup.com. 2018-07-09. Archived from the original on 2018-12-02. Retrieved 2018-12-02.
- ^ Health, Center for Devices and Radiological. "Laboratory Developed Tests". www.fda.gov. Archived from the original on 2019-04-23. Retrieved 2018-12-02.
- ^ Sullivan, Laurie L. "Technology Platform Shifts Shape Laboratory-Developed Testing Market". Archived from the original on 2018-12-02. Retrieved 2018-12-02.
- ^ "How Smart Clinical Laboratories and Genetic Testing Labs Are Collecting More Revenue by Pricing Tests to Meet the Expectations of Patients | Dark Daily". www.darkdaily.com. 23 May 2016. Archived from the original on 2018-12-02. Retrieved 2018-12-02.
Further reading
- Morris, S., Otto, N. C., Golemboski, K. (2013). Improving patient safety and healthcare quality in the 21st century—Competencies required of future medical laboratory science practitioners. Clinical Laboratory Science, 26, 200–204.
- Archibong, F., Atangwho, A., Ayuk, E. A., Okoye, E. I., Atroger, M., Okokon, B. I. (2019). Medical law: exploring doctor's knowledge on the laws regulating clinical and medical laboratories in Nigeria. Nigerian Journal of Medicine, 28(4), 386–392.
- Plebani, M., Laposata, M., Lippi, G. (2019). Driving the route of laboratory medicine: a manifesto for the future. Internal and Emergency Medicine, 14, 337–340.
- Goulding, M. H., Graham, L., Chorney, D., Rajendram, R. (2020). The use of interprofessional stimulation to improve collaboration and problem solving among undergraduate BHSc medical laboratory science and BScN nursing students. Canadian Journal of Medical Laboratory Science, 82(2), 25–33.