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A medical laboratory or clinical laboratory is a
laboratory A laboratory (; ; colloquially lab) is a facility that provides controlled conditions in which scientific or technological research, experiments, and measurement may be performed. Laboratory services are provided in a variety of settings: physicia ...
where tests are conducted out on clinical specimens to obtain information about the
health Health, according to the World Health Organization, is "a state of complete physical, mental and social well-being and not merely the absence of disease and infirmity".World Health Organization. (2006)''Constitution of the World Health Organiza ...
of a
patient A patient is any recipient of health care services that are performed by healthcare professionals. The patient is most often ill or injured and in need of treatment by a physician, nurse, optometrist, dentist, veterinarian, or other health c ...
to aid in diagnosis, treatment, and prevention of disease. Clinical Medical laboratories are an example of
applied science Applied science is the use of the scientific method and knowledge obtained via conclusions from the method to attain practical goals. It includes a broad range of disciplines such as engineering and medicine. Applied science is often contrasted ...
, as opposed to
research laboratories A research institute, research centre, research center or research organization, is an establishment founded for doing research. Research institutes may specialize in basic research or may be oriented to applied research. Although the term often im ...
that focus on
basic science Basic research, also called pure research or fundamental research, is a type of scientific research with the aim of improving scientific theories for better understanding and prediction of natural or other phenomena. In contrast, applied resear ...
, such as found in some
academic An academy (Attic Greek: Ἀκαδήμεια; Koine Greek Ἀκαδημία) is an institution of secondary education, secondary or tertiary education, tertiary higher education, higher learning (and generally also research or honorary membershi ...
institutions. 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. Doctors offices and clinics, as well as skilled nursing and
long-term care facilities A nursing home is a facility for the residential care of elderly or disabled people. Nursing homes may also be referred to as skilled nursing facility (SNF) or long-term care facilities. Often, these terms have slightly different meanings to i ...
, 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.


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. The two sections are: *
Anatomic pathology Anatomical pathology (''Commonwealth'') or Anatomic pathology (''U.S.'') is a medical specialty that is concerned with the diagnosis of disease based on the macroscopic, microscopic, biochemical, immunologic and molecular examination ...
: areas included here are
histopathology Histopathology (compound of three Greek words: ''histos'' "tissue", πάθος ''pathos'' "suffering", and -λογία '' -logia'' "study of") refers to the microscopic examination of tissue in order to study the manifestations of disease. Spe ...
,
cytopathology Cytopathology (from Greek , ''kytos'', "a hollow"; , ''pathos'', "fate, harm"; and , '' -logia'') is a branch of pathology that studies and diagnoses diseases on the cellular level. The discipline was founded by George Nicolas Papanicolaou in 1 ...
, and
electron microscopy An electron microscope is a microscope that uses a beam of accelerated electrons as a source of illumination. As the wavelength of an electron can be up to 100,000 times shorter than that of visible light photons, electron microscopes have a hi ...
. * Medical Laboratory, which typically includes the following areas: **
Clinical microbiology Medical microbiology, the large subset of microbiology that is applied to medicine, is a branch of medical science concerned with the prevention, diagnosis and treatment of infectious diseases. In addition, this field of science studies various ...
: This encompasses several different sciences, including
bacteriology Bacteriology is the branch and specialty of biology that studies the morphology, ecology, genetics and biochemistry of bacteria as well as many other aspects related to them. This subdivision of microbiology involves the identification, classificat ...
,
virology Virology is the Scientific method, scientific study of biological viruses. It is a subfield of microbiology that focuses on their detection, structure, classification and evolution, their methods of infection and exploitation of host (biology), ...
,
parasitology Parasitology is the study of parasites, their hosts, and the relationship between them. As a biological discipline, the scope of parasitology is not determined by the organism or environment in question but by their way of life. This means it fo ...
,
immunology Immunology is a branch of medicineImmunology for Medical Students, Roderick Nairn, Matthew Helbert, Mosby, 2007 and biology that covers the medical study of immune systems in humans, animals, plants and sapient species. In such we can see there ...
, and
mycology Mycology is the branch of biology concerned with the study of fungi, including their genetic and biochemical properties, their taxonomy and their use to humans, including as a source for tinder, traditional medicine, food, and entheogens, as ...
. **
Clinical chemistry Clinical chemistry (also known as chemical pathology, clinical biochemistry or medical biochemistry) is the area of chemistry that is generally concerned with analysis of bodily fluids for diagnostic and therapeutic purposes. It is an applied ...
: This area typically includes automated analysis of blood specimens, including tests related to
enzymology Enzymes () are proteins that act as biological catalysts by accelerating chemical reactions. The molecules upon which enzymes may act are called substrates, and the enzyme converts the substrates into different molecules known as products. A ...
,
toxicology Toxicology is a scientific discipline, overlapping with biology, chemistry, pharmacology, and medicine, that involves the study of the adverse effects of chemical substances on living organisms and the practice of diagnosing and treating expo ...
and
endocrinology Endocrinology (from '' endocrine'' + '' -ology'') is a branch of biology and medicine dealing with the endocrine system, its diseases, and its specific secretions known as hormones. It is also concerned with the integration of developmental event ...
. **
Hematology Hematology ( always spelled haematology in British English) is the branch of medicine concerned with the study of the cause, prognosis, treatment, and prevention of diseases related to blood. It involves treating diseases that affect the produc ...
: This area includes automated and manual analysis of blood cells. It also often includes
coagulation Coagulation, also known as clotting, is the process by which blood changes from a liquid to a gel, forming a blood clot. It potentially results in hemostasis, the cessation of blood loss from a damaged vessel, followed by repair. The mechanism o ...
. **
Blood bank A blood bank is a center where blood gathered as a result of blood donation is stored and preserved for later use in blood transfusion. The term "blood bank" typically refers to a department of a hospital usually within a Clinical Pathology laborat ...
involves the testing of blood specimens in order to provide blood transfusion and related services. **
Molecular diagnostics Molecular diagnostics is a collection of techniques used to analyze biological markers in the genome and proteome, and how their cells express their genes as proteins, applying molecular biology to medical testing. In medicine the technique is ...
DNA testing may be done here, along with a subspecialty known as
cytogenetics Cytogenetics is essentially a branch of genetics, but is also a part of cell biology/cytology (a subdivision of human anatomy), that is concerned with how the chromosomes relate to cell behaviour, particularly to their behaviour during mitosis an ...
. **
Reproductive biology Reproductive biology includes both sexual and asexual reproduction. Reproductive biology includes a wide number of fields: * Reproductive systems * Endocrinology * Sexual development (Puberty) * Sexual maturity * Reproduction * Fertility Human ...
testing is available in some laboratories, including
Semen analysis A semen analysis (plural: semen analyses), also called seminogram or spermiogram, evaluates certain characteristics of a male's semen and the sperm contained therein. It is done to help evaluate male fertility, whether for those seeking pregnancy ...
, Sperm bank and
assisted reproductive technology Assisted reproductive technology (ART) includes medical procedures used primarily to address infertility. This subject involves procedures such as in vitro fertilization (IVF), intracytoplasmic sperm injection (ICSI), cryopreservation of gametes o ...
. 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: *
Microbiology Microbiology () is the scientific study of microorganisms, those being unicellular (single cell), multicellular (cell colony), or acellular (lacking cells). Microbiology encompasses numerous sub-disciplines including virology, bacteriology, prot ...
includes culturing of clinical specimens, including
feces Feces ( or faeces), known colloquially and in slang as poo and poop, are the solid or semi-solid remains of food that was not digested in the small intestine, and has been broken down by bacteria in the large intestine. Feces contain a relati ...
,
urine Urine is a liquid by-product of metabolism in humans and in many other animals. Urine flows from the kidneys through the ureters to the urinary bladder. Urination results in urine being excretion, excreted from the body through the urethra. Cel ...
,
blood Blood is a body fluid in the circulatory system of humans and other vertebrates that delivers necessary substances such as nutrients and oxygen to the cells, and transports metabolic waste products away from those same cells. Blood in the c ...
,
sputum Sputum is mucus that is coughed up from the lower airways (the trachea and bronchi). In medicine, sputum samples are usually used for a naked eye examination, microbiological investigation of respiratory infections and cytological investigations ...
,
cerebrospinal fluid Cerebrospinal fluid (CSF) is a clear, colorless body fluid found within the tissue that surrounds the brain and spinal cord of all vertebrates. CSF is produced by specialised ependymal cells in the choroid plexus of the ventricles of the bra ...
, and synovial fluid, as well as possible infected tissue. The work here is mainly concerned with
cultures Culture () is an umbrella term which encompasses the social behavior, institutions, and norms found in human societies, as well as the knowledge, beliefs, arts, laws, customs, capabilities, and habits of the individuals in these groups.Tyl ...
, 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. *
Parasitology Parasitology is the study of parasites, their hosts, and the relationship between them. As a biological discipline, the scope of parasitology is not determined by the organism or environment in question but by their way of life. This means it fo ...
is where specimens are examined for
parasites Parasitism is a Symbiosis, close relationship between species, where one organism, the parasite, lives on or inside another organism, the Host (biology), host, causing it some harm, and is Adaptation, adapted structurally to this way of lif ...
. For example, fecal samples may be examined for evidence of intestinal parasites such as tapeworms or hookworms. *
Virology Virology is the Scientific method, scientific study of biological viruses. It is a subfield of microbiology that focuses on their detection, structure, classification and evolution, their methods of infection and exploitation of host (biology), ...
is concerned with identification of viruses in specimens such as
blood Blood is a body fluid in the circulatory system of humans and other vertebrates that delivers necessary substances such as nutrients and oxygen to the cells, and transports metabolic waste products away from those same cells. Blood in the c ...
,
urine Urine is a liquid by-product of metabolism in humans and in many other animals. Urine flows from the kidneys through the ureters to the urinary bladder. Urination results in urine being excretion, excreted from the body through the urethra. Cel ...
, and
cerebrospinal fluid Cerebrospinal fluid (CSF) is a clear, colorless body fluid found within the tissue that surrounds the brain and spinal cord of all vertebrates. CSF is produced by specialised ependymal cells in the choroid plexus of the ventricles of the bra ...
. *
Hematology Hematology ( always spelled haematology in British English) is the branch of medicine concerned with the study of the cause, prognosis, treatment, and prevention of diseases related to blood. It involves treating diseases that affect the produc ...
analyzes whole blood specimens to perform
full blood count A complete blood count (CBC), also known as a full blood count (FBC), is a set of medical laboratory tests that provide information about the cells in a person's blood. The CBC indicates the counts of white blood cells, red blood cells and plat ...
s, and includes the examination of
Blood film A blood smear, peripheral blood smear or blood film is a thin layer of blood smeared on a glass microscope slide and then stained in such a way as to allow the various blood cells to be examined microscopically. Blood smears are examined in the ...
s. Other specialized tests include cell counts on various bodily fluids. *
Coagulation Coagulation, also known as clotting, is the process by which blood changes from a liquid to a gel, forming a blood clot. It potentially results in hemostasis, the cessation of blood loss from a damaged vessel, followed by repair. The mechanism o ...
testing determines various blood clotting times, coagulation factors, and platelet function. *
Clinical biochemistry Clinical chemistry (also known as chemical pathology, clinical biochemistry or medical biochemistry) is the area of chemistry that is generally concerned with analysis of bodily fluids for diagnostic and therapeutic purposes. It is an applied ...
commonly performs dozens of different tests on serum or plasma. These tests, mostly automated, includes quantitative testing for a wide array of substances, such as
lipid Lipids are a broad group of naturally-occurring molecules which includes fats, waxes, sterols, fat-soluble vitamins (such as vitamins A, D, E and K), monoglycerides, diglycerides, phospholipids, and others. The functions of lipids include ...
s,
blood sugar Glycaemia, also known as blood sugar level, blood sugar concentration, or blood glucose level is the measure of glucose concentrated in the blood of humans or other animals. Approximately 4 grams of glucose, a simple sugar, is present in the blo ...
,
enzyme Enzymes () are proteins that act as biological catalysts by accelerating chemical reactions. The molecules upon which enzymes may act are called substrates, and the enzyme converts the substrates into different molecules known as products. A ...
s, and
hormone A hormone (from the Greek participle , "setting in motion") is a class of signaling molecules in multicellular organisms that are sent to distant organs by complex biological processes to regulate physiology and behavior. Hormones are required ...
s. *
Toxicology Toxicology is a scientific discipline, overlapping with biology, chemistry, pharmacology, and medicine, that involves the study of the adverse effects of chemical substances on living organisms and the practice of diagnosing and treating expo ...
is mainly focused on testing for pharmaceutical and recreational drugs.
Urine Urine is a liquid by-product of metabolism in humans and in many other animals. Urine flows from the kidneys through the ureters to the urinary bladder. Urination results in urine being excretion, excreted from the body through the urethra. Cel ...
and
blood Blood is a body fluid in the circulatory system of humans and other vertebrates that delivers necessary substances such as nutrients and oxygen to the cells, and transports metabolic waste products away from those same cells. Blood in the c ...
samples are the common specimens. *
Immunology Immunology is a branch of medicineImmunology for Medical Students, Roderick Nairn, Matthew Helbert, Mosby, 2007 and biology that covers the medical study of immune systems in humans, animals, plants and sapient species. In such we can see there ...
/
Serology Serology is the scientific study of Serum (blood), serum and other body fluids. In practice, the term usually refers to the medical diagnosis, diagnostic identification of Antibody, antibodies in the serum. Such antibodies are typically formed in r ...
uses the process of antigen-antibody interaction as a diagnostic tool. Compatibility of transplanted organs may also be determined with these methods. *
Immunohematology Immunohematology is a branch of hematology and transfusion medicine which studies antigen-antibody reactions and analogous phenomena as they relate to the pathogenesis and clinical manifestations of blood disorders. A person employed in this field ...
, or
blood bank A blood bank is a center where blood gathered as a result of blood donation is stored and preserved for later use in blood transfusion. The term "blood bank" typically refers to a department of a hospital usually within a Clinical Pathology laborat ...
determines
blood groups The term human blood group systems is defined by the International Society of Blood Transfusion (ISBT) as systems in the human species where cell-surface antigens—in particular, those on blood cells—are "controlled at a single gene locus or by ...
, 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. *
Urinalysis Urinalysis, a portmanteau of the words ''urine'' and ''analysis'', is a panel of medical tests that includes physical (macroscopic) examination of the urine, chemical evaluation using urine test strips, and microscopic examination. Macroscopic e ...
tests urine for many analysts, including microscopically. If more precise quantification of urine chemicals is required, the specimen is processed in the
clinical biochemistry Clinical chemistry (also known as chemical pathology, clinical biochemistry or medical biochemistry) is the area of chemistry that is generally concerned with analysis of bodily fluids for diagnostic and therapeutic purposes. It is an applied ...
lab. *
Histopathology Histopathology (compound of three Greek words: ''histos'' "tissue", πάθος ''pathos'' "suffering", and -λογία '' -logia'' "study of") refers to the microscopic examination of tissue in order to study the manifestations of disease. Spe ...
processes solid tissue removed from the body (
biopsies A biopsy is a medical test commonly performed by a surgeon, interventional radiologist, or an interventional cardiologist. The process involves extraction of sample cells or tissues for examination to determine the presence or extent of a diseas ...
) for evaluation at the microscopic level. *
Cytopathology Cytopathology (from Greek , ''kytos'', "a hollow"; , ''pathos'', "fate, harm"; and , '' -logia'') is a branch of pathology that studies and diagnoses diseases on the cellular level. The discipline was founded by George Nicolas Papanicolaou in 1 ...
examines smears of cells from all over the body (such as from the
cervix The cervix or cervix uteri (Latin, 'neck of the uterus') is the lower part of the uterus (womb) in the human female reproductive system. The cervix is usually 2 to 3 cm long (~1 inch) and roughly cylindrical in shape, which changes during ...
) for evidence of inflammation, cancer, and other conditions. *
Molecular diagnostics Molecular diagnostics is a collection of techniques used to analyze biological markers in the genome and proteome, and how their cells express their genes as proteins, applying molecular biology to medical testing. In medicine the technique is ...
includes specialized tests involving DNA and
RNA Ribonucleic acid (RNA) is a polymeric molecule essential in various biological roles in coding, decoding, regulation and expression of genes. RNA and deoxyribonucleic acid ( DNA) are nucleic acids. Along with lipids, proteins, and carbohydra ...
analysis. *
Cytogenetics Cytogenetics is essentially a branch of genetics, but is also a part of cell biology/cytology (a subdivision of human anatomy), that is concerned with how the chromosomes relate to cell behaviour, particularly to their behaviour during mitosis an ...
involves using blood and other cells to produce a DNA
karyotype A karyotype is the general appearance of the complete set of metaphase chromosomes in the cells of a species or in an individual organism, mainly including their sizes, numbers, and shapes. Karyotyping is the process by which a karyotype is disce ...
. This can be helpful in cases of prenatal diagnosis (e.g.
Down's syndrome Down syndrome or Down's syndrome, also known as trisomy 21, is a genetic disorder caused by the presence of all or part of a third copy of chromosome 21. It is usually associated with physical growth delays, mild to moderate intellectual disa ...
) as well as in some cancers which can be identified by the presence of abnormal
chromosome A chromosome is a long DNA molecule with part or all of the genetic material of an organism. In most chromosomes the very long thin DNA fibers are coated with packaging proteins; in eukaryotic cells the most important of these proteins are ...
s. *
Surgical pathology Surgical pathology is the most significant and time-consuming area of practice for most anatomical pathologists. Surgical pathology involves gross and microscopic examination of surgical specimens, as well as biopsies submitted by surgeons and ...
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 Pathology is the study of the causal, causes and effects of disease or injury. The word ''pathology'' also refers to the study of disease in general, incorporating a wide range of biology research fields and medical practices. However, when us ...
; cls: doctor medical laboratory science: Usa ls.d : africa mls:asia kgl :Germanyand ... * Clinical biochemist * Laboratory assistant (LA) *
Laboratory manager A laboratory manager (alternatively laboratory supervisor) is an individual who supervises personnel and operations in a laboratory environment; the position is senior to that of a laboratory technician or laboratory technologist, and is consider ...
*
Biomedical Scientist A biomedical scientist is a scientist trained in biology, particularly in the context of medical laboratory sciences or laboratory medicine. These scientists work to gain knowledge on the main principles of how the human body works and to find new w ...
(BMS) in the UK,
Medical laboratory scientist A medical laboratory scientist (MLS) or clinical laboratory scientist (CLS) or medical technologist (MT) performs diagnostic testing of blood and body fluids in clinical laboratories. The scope of a medical laboratory scientist's work begins wit ...
(MT, MLS or CLS) in the US or Medical Laboratory Technologist in Canada * Medical laboratory technician/clinical laboratory technician (MLT or CLT in US) * Medical laboratory assistant (MLA) *
Phlebotomist Phlebotomy is the process of making a puncture in a vein, usually in the arm, with a cannula for the purpose of drawing blood. The procedure itself is known as a venipuncture, which is also used for intravenous therapy. A person who performs a ph ...
(PBT) *
Histology Histology, also known as microscopic anatomy or microanatomy, is the branch of biology which studies the microscopic anatomy of biological tissues. Histology is the microscopic counterpart to gross anatomy, which looks at larger structures vis ...
technician


Labor shortages

The
United States The United States of America (U.S.A. or USA), commonly known as the United States (U.S. or US) or America, is a country primarily located in North America. It consists of 50 states, a federal district, five major unincorporated territorie ...
has a documented shortage of working laboratory professionals. For example, 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%. The higher numbers were seen in the
Phlebotomy Phlebotomy is the process of making a puncture in a vein, usually in the arm, with a cannula for the purpose of drawing blood. The procedure itself is known as a venipuncture, which is also used for intravenous therapy. A person who performs a p ...
and
Immunology Immunology is a branch of medicineImmunology for Medical Students, Roderick Nairn, Matthew Helbert, Mosby, 2007 and biology that covers the medical study of immune systems in humans, animals, plants and sapient species. In such we can see there ...
.
Microbiology Microbiology () is the scientific study of microorganisms, those being unicellular (single cell), multicellular (cell colony), or acellular (lacking cells). Microbiology encompasses numerous sub-disciplines including virology, bacteriology, prot ...
was another department that has had a struggle with vacancies. Their average in the 2018 survey was around 10-11% vacancy rate across the United States. 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. The National Center For Workforce Analysis has estimated that by 2025 there will be a 24% increase in demand for lab professionals. Highlighted by the
COVID-19 pandemic The COVID-19 pandemic, also known as the coronavirus pandemic, is an ongoing global pandemic of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The novel virus was first identif ...
, work is being done to address this shortage including bringing pathology and laboratory medicine into the conversation surrounding access to healthcare. 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.


Types of laboratory

In most developed countries, there are two main types of lab processing the majority of medical specimens. Hospital laboratories are attached to a
hospital A hospital is a health care institution providing patient treatment with specialized health science and auxiliary healthcare staff and medical equipment. The best-known type of hospital is the general hospital, which typically has an emerge ...
, 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 ( LIS). Inpatient specimens will already be labeled with patient and testing information provided by the LIS. Entry of test requests onto the LIS system involves typing (or scanning where barcodes are used) in the laboratory number, and entering the patient identification, as well as any tests requested. This allows laboratory analyzers, computers and staff to recognize what tests are pending, and also gives a location (such as a hospital department, doctor or other customer) for results reporting. 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 analyser An automated analyser is a medical laboratory instrument designed to measure different chemicals and other characteristics in a number of biological samples quickly, with minimal human assistance. These measured properties of blood and other fluids ...
s, that process a fraction of the sample to return one or more test results. Some laboratories use robotic sample handlers (
Laboratory automation Laboratory automation is a multi-disciplinary strategy to research, develop, optimize and capitalize on technologies in the laboratory that enable new and improved processes. Laboratory automation professionals are academic, commercial and gover ...
) 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
phlebotomist Phlebotomy is the process of making a puncture in a vein, usually in the arm, with a cannula for the purpose of drawing blood. The procedure itself is known as a venipuncture, which is also used for intravenous therapy. A person who performs a ph ...
s for results to be available in the patient's charts for the attending physicians to consult during their morning rounds. Another busy time for the lab is after 3:00 pm when private practice physician offices are closing. Couriers will pick up specimens that have been drawn throughout the day and deliver them to the lab. Also, couriers will stop at outpatient drawing centers and pick up specimens. These specimens will be processed in the evening and overnight to ensure results will be available the following day.


Laboratory informatics

The large amount of information processed in laboratories is managed by a system of software programs, computers, and terminology standards that exchange data about patients, test requests, and test results known as a
Laboratory information system A laboratory information management system (LIMS), sometimes referred to as a laboratory information system (LIS) or laboratory management system (LMS), is a software-based solution with features that support a modern laboratory's operations. K ...
or LIS. The LIS is often interfaced with the
hospital information system A hospital information system (HIS) is an element of health informatics that focuses mainly on the administrational needs of hospitals. In many implementations, a HIS is a comprehensive, integrated information system designed to manage all the asp ...
, EHR and/or Laboratory instruments. Formats for terminologies for test processing and reporting are being standardized with systems such as
Logical Observation Identifiers Names and Codes Logical Observation Identifiers Names and Codes (LOINC) is a database and universal standard for identifying medical laboratory observations. First developed in 1994, it was created and is maintained by the Regenstrief Institute, a US nonprofit me ...
(LOINC) and Nomenclature for Properties and Units terminology (NPU terminology). 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 Pathology is the study of the causal, causes and effects of disease or injury. The word ''pathology'' also refers to the study of disease in general, incorporating a wide range of biology research fields and medical practices. However, when us ...
. 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 (
pathologist Pathology is the study of the causal, causes and effects of disease or injury. The word ''pathology'' also refers to the study of disease in general, incorporating a wide range of biology research fields and medical practices. However, when us ...
or
clinical Laboratory A medical laboratory or clinical laboratory is a laboratory where tests are conducted out on clinical specimens to obtain information about the health of a patient to aid in diagnosis, treatment, and prevention of disease. Clinical Medical labor ...
) is involved with interpretation and consulting. Medical staff are sometimes also required in order to explain pathology results to
physician A physician (American English), medical practitioner (Commonwealth English), medical doctor, or simply doctor, is a health professional who practices medicine, which is concerned with promoting, maintaining or restoring health through th ...
s. For a simple result given by phone or to explain a technical problem, often a medical technologist or medical lab scientist can provide additional information. 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 (
Pharm.D. A Doctor of Pharmacy (PharmD; New Latin: ''Pharmaciae Doctor'') is a professional doctorate in pharmacy. In some countries, it is a doctoral degree to practice the profession of pharmacy or to become a clinical pharmacist. In many countries th ...
and
M.D. Doctor of Medicine (abbreviated M.D., from the Latin ''Medicinae Doctor'') is a medical degree, the meaning of which varies between different jurisdictions. In the United States, and some other countries, the M.D. denotes a professional degree. T ...
specialized in
anatomical pathology Anatomical pathology (''Commonwealth'') or Anatomic pathology (''U.S.'') is a medical specialty that is concerned with the diagnosis of disease based on the macroscopic, microscopic, biochemical, immunologic and molecular examination ...
or
clinical Laboratory Science Health technology is defined by the World Health Organization as the "application of organized knowledge and skills in the form of devices, medicines, vaccines, procedures, and systems developed to solve a health problem and improve quality of liv ...
) 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 ''ISO 15189 Medical laboratories — Requirements for quality and competence'' is an international standard that specifies the quality management system requirements particular to medical laboratories. The standard was developed by the Internatio ...
- ''Medical laboratories - Requirements for quality and competence.'' In the United States, billions of dollars is spent on unaccredited lab tests, such as Laboratory developed tests which do not require accreditation or FDA approval; about a billion USD a year is spent on US autoimmune LDTs alone. Accreditation is performed by the
Joint Commission The Joint Commission is a United States-based nonprofit tax-exempt 501(c) organization that accredits more than 22,000 US health care organizations and programs. The international branch accredits medical services from around the world. A majori ...
,
College of American Pathologists The College of American Pathologists (CAP) is a member-based physician organization founded in 1946 comprising approximately 18,000 board-certified pathologists. It serves patients, pathologists, and the public by fostering and advocating ...
, AAB (American Association of Bioanalysts), and other state and federal agencies. Legislative guidelines are provided under CLIA 88 (
Clinical Laboratory Improvement Amendments The Clinical Laboratory Improvement Amendments (CLIA) of 1988 are United States federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States, except clinical trials and basic research. CLIA P ...
) which regulates Medical Laboratory testing and personnel. 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. In the United Arab Emirates, the Dubai Accreditation Department
DAC
is the accreditation body that is internationally recognised by the
International Laboratory Accreditation Cooperation The International Laboratory Accreditation Cooperation or ILAC started as a conference in 1977 with the aim of developing international cooperation for facilitating trade by promotion of the acceptance of accredited test and calibration results. ...
(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 Biotechnology is the integration of natural sciences and engineering sciences in order to achieve the application of organisms, cells, parts thereof and molecular analogues for products and services. The term ''biotechnology'' was first used b ...
companies). Clinical laboratory services includes large
multinational corporation A multinational company (MNC), also referred to as a multinational enterprise (MNE), a transnational enterprise (TNE), a transnational corporation (TNC), an international corporation or a stateless corporation with subtle but contrasting senses, i ...
s such
LabCorp Laboratory Corporation of America Holdings, more commonly known as Labcorp, is an American healthcare company headquartered in Burlington, North Carolina. It operates one of the largest clinical laboratory networks in the world, with a United St ...
,
Quest Diagnostics Quest Diagnostics is an American clinical laboratory. A Fortune 500 company, Quest operates in the United States, Puerto Rico, Mexico, and Brazil. Quest also maintains collaborative agreements with various hospitals and clinics across the globe. ...
, and
Sonic Healthcare Sonic Healthcare Limited is a Sydney-based, Australian company that provides laboratory services, pathology, and radiology services. Scope Sonic Healthcare Limited has a presence in Australia, New Zealand, United States, United Kingdom, Germ ...
but a significant portion of revenue, estimated at 60% in the United States, is generated by hospital labs. In 2018, the total global revenue for these companies was estimated to reach $146 billion by 2024. Another estimate places the market size at $205 billion, reaching $333 billion by 2023. The
American Association for Clinical Chemistry AACC (formerly known as the American Association for Clinical Chemistry) is a global scientific society dedicated to clinical laboratory science and its application to healthcare. AACC's current president is Carmen Wiley, PhD, and the association ...
(AACC) represents professionals in the field. 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 Thermo Fisher Scientific Inc. is an American supplier of scientific instrumentation, reagents and consumables, and software services. Based in Waltham, Massachusetts, Thermo Fisher was formed through the merger of Thermo Electron and Fisher S ...
. In 2016, global life sciences instrumentation sales were around $47 billion, not including consumables, software, and services. 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. , the in-vitro-diagnostics (IVD) market was estimated at a global value of around $61.22 billion, with companies:
Roche Diagnostics F. Hoffmann-La Roche AG, commonly known as Roche, is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has shares listed on the SIX S ...
, Abbott Diagnostics,
Siemens Healthineers Siemens Healthineers AG (formerly Siemens Healthcare, Siemens Medical Solutions, Siemens Medical Systems) is a German medical device company. It is the parent company for several medical technology companies and is headquartered in Erlangen, Germ ...
, Johnson & Johnson Medical Devices and Diagnostics,
Beckman Coulter Beckman Coulter Inc. is a Danaher Corporation company that develops, manufactures, and markets products that simplify, automate and innovate complex biomedical testing. It operates in two industries: Diagnostics and Life Sciences. For more than ...
and BioMerieux. Many of the companies sell capital equipment and supply consumables, and the devices are also used for industrial purposes such as food testing.
Molecular diagnostics Molecular diagnostics is a collection of techniques used to analyze biological markers in the genome and proteome, and how their cells express their genes as proteins, applying molecular biology to medical testing. In medicine the technique is ...
is estimated at 10% of total revenue, and half of that focused on infectious disease testing. Blood transfusion diagnostics has become increasingly important with the prevalence of infectious and chronic diseases, with companies like: Grifols S.A., Bio-Rad Laboratories, Inc., Quotient Limited, and Immucor, Inc.


United States

In the United States, estimated total revenue as of 2016 was $75 billion, about 2% of total healthcare spending. In 2016, an estimated 60% of revenue was done by hospital labs, with 25% done by two independent companies (LabCorp and Quest). Hospital labs may also outsource their lab, known as outreach, to run tests; however,
health insurers Health insurance or medical insurance (also known as medical aid in South Africa) is a type of insurance that covers the whole or a part of the risk of a person incurring medical expenses. As with other types of insurance, risk is shared among ma ...
may pay the hospitals more than they would pay a laboratory company for the same test, but as of 2016, the markups were questioned by insurers. Rural hospitals, in particular, can bill for lab outreach under the Medicare's 70/30 shell rule. Laboratory developed tests are designed and developed inside a specific laboratory and do not require FDA approval; due to technological innovations, they have become more common and are estimated at a total value of $11 billion in 2016. Due to the rise of
high-deductible health plan In the United States, a high-deductible health plan (HDHP) is a health insurance plan with lower premiums and higher deductibles than a traditional health plan. It is intended to incentivize consumer-driven healthcare. Being covered by an HDHP ...
s, laboratories have sometimes struggled to collect when billing patients; consequently, some laboratories have shifted to become more "consumer-focused".


See also

*
ARUP Laboratories Associated Regional and University Pathologists, Inc. (ARUP Laboratories) is a Salt Lake City, Utah-based nonprofit laboratory at University of Utah's Department of Pathology. It is located in the University of Utah Research Park and provides nat ...
*
Healthcare scientist A healthcare scientist or medical scientist is a scientist working in any of a number of health related disciplines. Healthcare scientists may work directly for health service providers, or in academia or industry. Healthcare scientists typically re ...
*
Point-of-care testing Point-of-care testing (POCT or bedside testing) is defined as medical diagnostic testing at or near the point of care—that is, at the time and place of patient care. This contrasts with the historical pattern in which testing was wholly or most ...


References


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. {{Authority control Clinical pathology Laboratory types Medical diagnosis