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Clinical pathology is amedical specialty that is concerned with the diagnosis of disease based on thelaboratory analysis ofbodily fluids, such asblood,urine, and tissue homogenates or extracts using the tools ofchemistry,microbiology,hematology,molecular pathology, andImmunohaematology. This specialty requires amedical residency.
Clinical pathology is a term used in the US, UK, Ireland,many Commonwealth countries, Portugal, Brazil, Italy, Japan, and Peru; countries using the equivalent in the home language of "laboratory medicine" include Austria, Germany, Romania, Poland and otherEastern European countries; other terms are "clinical analysis" (Spain) and "clinical/medical biology (France, Belgium, Netherlands, North and West Africa).[1]
TheAmerican Board of Pathology certifies clinical pathologists, and recognizes the following secondary specialties of clinical pathology:
In some countries other sub specialities fall under certifiedClinical Biologists responsibility:[2]
Clinical pathologists are often medical doctors. In some countries inSouth-America,Europe,Africa orAsia, this specialty can be practiced by non-physicians, such as Ph.D. or Pharm.D. after a variable number of years ofresidency.
Clinical pathologists work in close collaboration with clinical scientists (clinical biochemists, clinical microbiologists, etc.),medical technologists, hospital administrators, and referring physicians to ensure the accuracy and optimal utilization of laboratory testing.
Clinical pathology is one of the two major divisions ofpathology, the other beinganatomical pathology. Often,pathologists practice both anatomical and clinical pathology, a combination sometimes known asgeneral pathology. Similar specialties exist inveterinary pathology.
Clinical pathology is itself divided into subspecialties, the main ones beingclinical chemistry,clinical hematology/blood banking,hematopathology andclinical microbiology and emerging subspecialties such asmolecular diagnostics andproteomics. 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 USDepartment of Health and Human Services approved Board CertifiedPh.D.,DSc, orMD andDO 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 asplatelet aggregometry,hemoglobin or serum proteinelectrophoresis, orcoagulation profiles. If interfering substances are suspected, they may recommend alternate test methods. For example,hemolysis, icterus,lipemia, or heterophile antibodies may confound results obtained by traditional methods such as ion-selective electrodes, enzymatic assays orimmunoassays. Alternate methods such as blood gas analysers,point-of-care testing ormass spectrometry may help resolve the clinical question.
Recently,EFLM 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 asClinical Biologist rather than "Clinicalpathologist".[5]
Microscopes, analyzers, strips, centrifuges
Visual examination of the specimen may provide information to the pathologist or the physician. For example, fluid drained from anabscess may appear cloudy, orcerebrospinal fluid obtained bylumbar puncture may exhibitxanthochromia, suggesting a bleed has occurred. Laboratory technologists may provide qualitative descriptions accordingly.
Microscopic analysis is an important activity of the pathologist and the laboratory technologist. They have many different stains at their disposal (GRAM, MGG,Grocott,Ziehl–Neelsen, etc.). Immunofluorescence, cytochemistry, the immunocytochemistry, andFISH are also used in order make a correct diagnosis.
Pathologists may review samples such aspleural,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.
Automated analysers, 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, automatedwhite 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 asflow cytometry to identifylymphoma orleukemia cells, orcytology to characterize solid tumor cells.
Samples undergoing examination for pathogens, primarily inmedical microbiology, may be incubated with culture media. Those allow, for example, the description of one or several infectious agents responsible of the clinical signs.
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