# Clinical pathology

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Medical specialty

This article needs more reliable medical references for verification or relies too heavily on primary sources. Please review the contents of the article and add the appropriate references if you can. Unsourced or poorly sourced material may be challenged and removed. Find sources: "Clinical pathology" – news · newspapers · books · scholar · JSTOR (March 2023)

[Hematology](/source/Hematology): [Blood](/source/Blood) smears on a glass slide, stained and ready to be examined under the microscope.

[Bacteriology](/source/Bacteriology): [Agar](/source/Agar) plate with bacterial colonies.

[Bacteriology](/source/Bacteriology): microscopic image of a mixture of two types of [bacteria](/source/Bacteria) stained with the [Gram stain](/source/Gram_stain).

[Clinical chemistry](/source/Clinical_chemistry): an automated blood chemistry analyser.

**Clinical pathology** is a [medical specialty](/source/Medical_specialty) that is concerned with the diagnosis of disease based on the [laboratory](/source/Medical_laboratory) analysis of [bodily fluids](/source/Bodily_fluid), such as [blood](/source/Blood), [urine](/source/Urine), and tissue homogenates or extracts using the tools of [chemistry](/source/Clinical_chemistry), [microbiology](/source/Clinical_microbiology), [hematology](/source/Hematology), [molecular pathology](/source/Molecular_pathology), and [Immunohaematology](/source/Immunohaematology). This specialty requires a [medical residency](/source/Medical_residency).

Clinical pathology is a term used in the US, UK, Ireland, [many Commonwealth countries](/source/Commonwealth_of_Nations), Portugal, Brazil, Italy, Japan, and Peru; countries using the equivalent in the home language of "laboratory medicine" include Austria, Germany, Romania, Poland and other [Eastern European](/source/Eastern_Europe) countries; other terms are "clinical analysis" (Spain) and "clinical/medical biology (France, Belgium, Netherlands, North and West Africa).[1]

## Licensing and subspecialities

The [American Board of Pathology](/source/American_Board_of_Pathology) certifies clinical pathologists, and recognizes the following secondary specialties of clinical pathology:

- [Chemical pathology](/source/Clinical_chemistry), also called [clinical chemistry](/source/Clinical_chemistry)

- [Hematopathology](/source/Hematopathology)

- [Blood banking](/source/Blood_banking) - [Transfusion medicine](/source/Transfusion_medicine)

- [Clinical microbiology](/source/Clinical_microbiology)

- [Cytogenetics](/source/Cytogenetics)

- [Molecular genetics pathology](/source/Molecular_pathology).

In some countries other sub specialities fall under certified [Clinical Biologists](/source/Clinical_Biologist) responsibility:[2]

- [Reproductive biology](/source/Reproductive_biology) including [Assisted reproductive technology](/source/Assisted_reproductive_technology), [Sperm bank](/source/Sperm_bank) and [Semen analysis](/source/Semen_analysis)

- [Immunopathology](/source/Immunopathology)

## Organization

Clinical pathologists are often medical doctors. In some countries in [South America](/source/South_America), [Europe](/source/Europe), [Africa](/source/Africa) or [Asia](/source/Asia), this specialty can be practiced by non-physicians, such as Ph.D. or Pharm.D. after a variable number of years of [residency](/source/Residency_(medicine)).

### In the United States

Clinical pathologists work in close collaboration with clinical scientists (clinical biochemists, clinical microbiologists, etc.), [medical technologists](/source/Medical_technologist), hospital administrators, and referring physicians to ensure the accuracy and optimal utilization of laboratory testing.

Clinical pathology is one of the two major divisions of [pathology](/source/Pathology), the other being [anatomical pathology](/source/Anatomical_pathology). Often, [pathologists](/source/Pathology_as_a_medical_specialty) practice both anatomical and clinical pathology, a combination sometimes known as [general pathology](/source/General_pathology). Similar specialties exist in [veterinary pathology](/source/Veterinary_pathology).

Clinical pathology is itself divided into subspecialties, the main ones being [clinical chemistry](/source/Clinical_chemistry), [clinical hematology](/source/Hematology)/[blood banking](/source/Blood_banking), [hematopathology](/source/Hematopathology) and [clinical microbiology](/source/Clinical_microbiology) and emerging subspecialties such as [molecular diagnostics](/source/Molecular_diagnostics) and [proteomics](/source/Proteomics). Many areas of clinical pathology overlap with anatomic pathology. Both can serve as medical directors of CLIA certified laboratories. Under the CLIA law, only the US [Department of Health and Human Services](/source/Department_of_Health_and_Human_Services) approved Board Certified [Ph.D.](/source/Doctor_of_Philosophy), [DSc](/source/Doctor_of_Science), or [MD](/source/Doctor_of_Medicine) and [DO](/source/Doctor_of_Osteopathic_Medicine) can perform the duties of a Medical or Clinical Laboratory Director. This overlap includes immunoassays, flow cytometry, microbiology and cytogenetics and any assay done on tissue. Overlap between anatomic and clinical pathology is expanding to molecular diagnostics and proteomics as we move towards making the best use of new technologies for personalized medicine.[3]

Clinical pathologists may assist physicians in interpreting complex tests such as [platelet](/source/Platelet) aggregometry, [hemoglobin](/source/Hemoglobin) or serum protein [electrophoresis](/source/Electrophoresis), or [coagulation](/source/Coagulation) profiles. If interfering substances are suspected, they may recommend alternate test methods. For example, [hemolysis](/source/Hemolysis), icterus, [lipemia](/source/Lipemia), or heterophile antibodies may confound results obtained by traditional methods such as ion-selective electrodes, enzymatic assays or [immunoassays](/source/Immunoassay). Alternate methods such as blood gas analysers, [point-of-care testing](/source/Point-of-care_testing) or [mass spectrometry](/source/Mass_spectrometry) may help resolve the clinical question.

### In Europe

Recently, [EFLM](https://en.wikipedia.org/w/index.php?title=EFLM&action=edit&redlink=1) has chosen the name of "Specialists in Laboratory Medicine" to define all European Clinical pathologists, regardless of their training (M.D., Ph.D. or Pharm.D.).[4]

In France, Clinical Pathology is called Medical Biology ("Biologie médicale") and is practiced by both M.D.s and Pharm.D.s. The residency lasts four years. Specialists in this discipline are called "Biologiste médical" which literally translates as [Clinical Biologist](/source/Clinical_Biologist) rather than "Clinical [pathologist](/source/Pathologist)".[5]

## Tools

Tangible tools include microscopes, analyzers, strips, and centrifuges.

### Macroscopic examination

Visual examination of the specimen may provide information to the pathologist or the physician. For example, fluid drained from an [abscess](/source/Abscess) may appear cloudy, or [cerebrospinal fluid](/source/Cerebrospinal_fluid) obtained by [lumbar puncture](/source/Lumbar_puncture) may exhibit [xanthochromia](/source/Xanthochromia), suggesting a bleed has occurred. Laboratory technologists may provide qualitative descriptions accordingly.

### Microscopical examination

See also: [staining](/source/Staining)

Microscopic analysis is an important activity of the pathologist and the laboratory technologist. They have many different stains at their disposal ([GRAM](/source/Gram_stain), MGG, [Grocott](/source/Grocott's_methenamine_silver_stain), [Ziehl–Neelsen](/source/Ziehl%E2%80%93Neelsen_stain), etc.). Immunofluorescence, cytochemistry, the immunocytochemistry, and [FISH](/source/Fluorescence_in_situ_hybridization) are also used in order make a correct diagnosis.

Pathologists may review samples such as [pleural](/source/Pleural), [peritoneal](/source/Peritoneal), synovial, or pericardial fluids to characterize them as "normal", tumoral, inflammatory, or even infectious. Microscopic examination can also determine the causal infectious agent – often a bacterium, mould, yeast, parasite, or (rarely) virus.

### Laboratory Analysers

[Automated analysers](/source/Automated_analyser), by the association of robotics and spectrophotometry, have allowed these last decades better reproducibility of the results, in particular in medical biochemistry and hematology.[6]

Efficiency and productivity can be enhanced by automating the pre-analytical processing, including barcode reading, sorting, centrifuging, and aliquoting specimens.

The analysers must undergo daily controls prior to performing patient testing. Analysers must also undergo daily, weekly and monthly maintenance. Quality management involves reviewing quality control trends to detect emerging problems in instrument calibration, correlating results between instruments that perform similar testing, and running standardized samples to prove linearity and precision.

Some laboratory processes involve automated analysis combined with manual review by technologists. For example, when hematology analysers flag samples as abnormal, automated [white blood cell](/source/White_blood_cell) differential counts may be superseded by manual differential counts using stained slides read at the microscope or scanned by digital imaging software. Laboratory technologists may flag abnormal samples for pathologist review. The pathologist may recommend additional testing, such as [flow cytometry](/source/Flow_cytometry) to identify [lymphoma](/source/Lymphoma) or [leukemia](/source/Leukemia) cells, or [cytology](/source/Cytology) to characterize solid tumor cells.

### Cultures

Samples undergoing examination for pathogens, primarily in [medical microbiology](/source/Medical_microbiology), may be incubated with culture media. Those allow, for example, the description of one or several infectious agents responsible of the clinical signs.

### Values known as "normal" or reference values

Main article: [Reference range](/source/Reference_range)

A reference range in medicine is the [range](/source/Range_(statistics)) or the [interval](/source/Interval_(mathematics)) of values that is deemed normal for a [physiological](/source/Physiology) measurement in healthy persons (for example, the amount of [creatinine](/source/Creatinine) in the [blood](/source/Blood), or the [partial pressure of oxygen](/source/Blood_gas_tension)). It is a basis for comparison for a [physician](/source/Physician) or other [health professional](/source/Health_professional) to interpret a set of test results for a particular patient. Some important reference ranges in medicine are [reference ranges for blood tests](/source/Reference_ranges_for_blood_tests) and [reference ranges for urine tests](/source/Urinalysis#Target_parameters).

## See also

- [Pathology](/source/Pathology)

- [Medical laboratory](/source/Medical_laboratory)

- [Anatomic pathology](/source/Anatomic_pathology)

- [Medical technologist](/source/Medical_technologist)

- [Veterinary pathology](/source/Veterinary_pathology)

- [Clinical Biologist](/source/Clinical_Biologist)

## Notes and references

1. **[^](#cite_ref-1)** ["Textes Généraux, Ministère de la Santé et des Sports"](http://www.legifrance.gouv.fr/jo_pdf.do?cidTexte=JORFTEXT000022363470). *Journal Officiel de la République Française*. Décrets, arrêtés, circulaires (Texte 15 sur 54). 20 June 2010. Retrieved 4 December 2019. Note: This document does not cover all countries listed.

1. **[^](#cite_ref-2)** ["Bulletin officiel du n°32 du 4 septembre 2003 - MENS0301444A"](https://www.education.gouv.fr/bo/2003/32/MENS0301444A.htm). *www.education.gouv.fr*. Retrieved 2023-02-21.

1. **[^](#cite_ref-3)** [Description of Pathology in USA](https://web.archive.org/web/20060908012542/http://www.pathology.ecu.edu/Public/resident/recruit.ppt)

1. **[^](#cite_ref-4)** Zerah Simone, Murray Janet, Rita Horvath Andrea (2012). ["EFLM Position Statement – Our profession now has a European name: Specialist in Laboratory Medicine"](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3900053). *Biochemia Medica*. **22** (3): 272–273. [doi](/source/Doi_(identifier)):[10.11613/BM.2012.029](https://doi.org/10.11613%2FBM.2012.029). [PMC](/source/PMC_(identifier)) [3900053](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3900053). [PMID](/source/PMID_(identifier)) [23092058](https://pubmed.ncbi.nlm.nih.gov/23092058).{{[cite journal](https://en.wikipedia.org/wiki/Template:Cite_journal)}}: CS1 maint: multiple names: authors list ([link](https://en.wikipedia.org/wiki/Category:CS1_maint:_multiple_names:_authors_list))

1. **[^](#cite_ref-5)** [Reglementation for French Residency in Clinical Pathology](http://www.sante.gouv.fr/adm/dagpb/bo/2003/03-05/a0050272.htm) [Archived](https://web.archive.org/web/20080228225540/http://www.sante.gouv.fr/adm/dagpb/bo/2003/03-05/a0050272.htm) 2008-02-28 at the [Wayback Machine](/source/Wayback_Machine)

1. **[^](#cite_ref-6)** More D, Khan N, Tekade RK, Sengupta P. An Update on Current Trend in Sample Preparation Automation in Bioanalysis: strategies, Challenges and Future Direction. Crit Rev Anal Chem. 2024 Jul 1:1-25. doi: 10.1080/10408347.2024.2362707. Epub ahead of print. PMID 38949910.

## External links

- [American Association for Clinical Chemistry](http://www.aacc.org)

- [American Society for Clinical Pathology](https://www.ascp.org)

- [American Board of Pathology](https://www.abpath.org)

- [College of American Pathologists](https://www.cap.org)

- [European Federation of Clinical Chemistry and Laboratory Medicine](http://www.efcclm.eu)

- [Academy of Clinical Laboratory Physicians and Scientists](https://www.aclps.org)

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Adapted from the Wikipedia article [Clinical pathology](https://en.wikipedia.org/wiki/Clinical_pathology) by Wikipedia contributors ([contributor history](https://en.wikipedia.org/wiki/Clinical_pathology?action=history)). Available under [Creative Commons Attribution-ShareAlike 4.0 International](https://creativecommons.org/licenses/by-sa/4.0/). Changes may have been made.
