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Medical laboratory
A medical laboratory or clinical laboratory is a
laboratory where tests are carried out on clinical specimens
to obtain information about the health of a patient to aid in
diagnosis, treatment, and prevention of disease.[1] Clinical
Medical laboratories are an example of applied science, as
opposed to research laboratories that focus on basic science,
such as found in some academic 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 Clinical laboratory in a hospital setting
[2] showing several automated analysers.
testing. 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]

Contents
Departments
Medical laboratory staff
Labor shortages
Types of laboratory
Specimen processing and work flow
Laboratory informatics
Result analysis, validation and interpretation
Medical laboratory accreditation
Industry
United States
See also
References

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:

Anatomic pathology: areas included here are histopathology, cytopathology, and electron
microscopy.
Medical Laboratory, which typically includes the following areas:[5]

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Clinical microbiology: This encompasses several different sciences, including bacteriology,

virology, parasitology, immunology, and mycology.[6]
Clinical chemistry: This area typically includes automated analysis of blood specimens,
including tests related to enzymology, toxicology and endocrinology.[7]
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:

Microbiology includes culturing of clinical specimens,

including feces, urine, blood, sputum, cerebrospinal fluid,
and synovial fluid, as well as possible infected tissue. The
work here is mainly concerned with 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 Laboratory equipment for hematology
with the identified organism(s) and the type and amount of (black analyser) and urinalysis (left of
drug(s) that should be prescribed for the patient. the open centrifuge).
Parasitology is where specimens are examined for
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.
Hematology analyzes whole blood specimens to perform full blood counts, and includes the
examination of Blood films. Other specialized tests include cell counts on various bodily fluids.
Coagulation testing determines various blood clotting times, coagulation factors, and platelet
function.
Clinical biochemistry 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
lipids, blood sugar, enzymes, and hormones.
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.
Immunohematology, or blood bank determines 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.
Urinalysis tests urine for many analysts, including microscopically. If more precise quantification
of urine chemicals is required, the specimen is processed in the clinical biochemistry lab.

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Histopathology processes solid tissue removed from the body (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 analysis.
Cytogenetics involves using blood and other cells to produce a DNA karyotype. This can be
helpful in cases of prenatal diagnosis (e.g. 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; Dcls(Doctor clinical Laboratory science)

Clinical biochemist
Laboratory assistant (LA)
Biomedical Scientist (BMS) in the UK, Medical laboratory
scientist (MT, MLS or CLS) in the US or Medical Laboratory
Technologist in Canada
Medical laboratory technician/clinical laboratory technician
(MLT or CLT in US) Clinical laboratory in a Hospital setting
Medical laboratory assistant (MLA) with two technologists shown.

Phlebotomist (PBT)
Histology technician

Labor shortages
The United States has a documented shortage of working laboratory professionals. For example, as of
2016 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. The National Center For Workforce Analysis has estimated that by 2025 there
will be a 24% increase in demand for lab professionals.[11][12]

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, 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
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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 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
phlebotomists 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 or LIS. The LIS is often interfaced with
the hospital information system, 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 (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

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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 (pathologist or clinical Laboratory) is involved
with interpretation and consulting. Medical staff are sometimes also required in order to explain
pathology results to physicians. 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. and M.D. specialized in anatomical pathology or clinical
Laboratory Science) 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 Laboratory
developed tests which do not require accreditation or FDA approval; about a billion USD a year is
spent on US autoimmune LDTs alone.[13] Accreditation is performed by the Joint Commission,
College of American Pathologists, AAB (American Association of Bioanalysts), and other state and
federal agencies. Legislative guidelines are provided under CLIA 88 (Clinical Laboratory
Improvement Amendments) 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.[14]

In the United Arab Emirates, the Dubai Accreditation Department (DAC (http://www.dac.dm.ae)) is
the accreditation body that is internationally recognised[15] 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 (http://www.hkas.go
v.hk)). 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 (https://accreditation.ca/)) is the national reference. Different provincial
oversight bodies mandate laboratories in EQA participations like LSPQ (Quebec), IQMH (Ontario)
for example.

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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).[16]

Clinical laboratory services includes large multinational corporations such LabCorp, Quest
Diagnostics, and Sonic Healthcare[17] but a significant portion of revenue, estimated at 60% in the
United States, is generated by hospital labs.[18] In 2018, the total global revenue for these companies
was estimated to reach $146 billion by 2024.[19] Another estimate places the market size at
$205 billion, reaching $333 billion by 2023.[20] The American Association for Clinical Chemistry
(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.[21] In 2016, global life sciences instrumentation sales were around
$47 billion, not including consumables, software, and services.[21] 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.[22]

As of 2018, the in-vitro-diagnostics (IVD) market was estimated at a global value of around
$61.22 billion, with companies: Roche Diagnostics, Abbott Diagnostics, Siemens Healthineers,
Johnson & Johnson Medical Devices and Diagnostics, Beckman Coulter and BioMerieux.[16] [23]
Many of the companies sell capital equipment and supply consumables, and the devices are also used
for industrial purposes such as food testing.[16] Molecular diagnostics is estimated at 10% of total
revenue, and half of that focused on infectious disease testing.[16] 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,[24] and Immucor, Inc. [25]
[26]

United States

In the United States, estimated total revenue as of 2016 was $75 billion, about 2% of total healthcare
spending.[17] In 2016, an estimated 60% of revenue was done by hospital labs, with 25% done by two
independent companies (LabCorp and Quest).[18] Hospital labs may also outsource their lab, known
as outreach, to run tests; however, health insurers 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.[27]
Rural hospitals, in particular, can bill for lab outreach under the Medicare's 70/30 shell rule.[28]

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[29] and are
estimated at a total value of $11 billion in 2016.[30]

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".[31]

See also
ARUP Laboratories

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Healthcare scientist
Point-of-care testing

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