Clinical pathology is a medical field that oversees all the laboratory functions in a clinic. It covers the activities done in the microbiology lab, serology, toxicology, and immunohistochemistry laboratories. There is hardly any clinic that does not have a clinical pathology unit, this field plays a vital role in the diagnosis, preventive and curative process in disease examination. Above all, it ensures that the quality of results and examination are given to patients in accordance with the diagnosis.
Specifically, in the immunohistochemistry (IHC) laboratory, the clinical pathology lab must be fully equipped with state of the art equipment, and tools which ensure the quality of results produced. The sensitivity of the staining processes in IHC demands that measures are put in place to establish quality control of results. For instance, the collection of tissue sample which is the first in the staining process is one vital step that necessitates great care. It must be done aseptically.
During this process, the clinical pathology laboratory collects tissue samples and accurately assign an identification number to the sample. Quality control at this stage prevents contamination and miss-identification of the specimen. Another stage worth implementing quality control is the analytical phase, at this stage, the clinical pathology lab performs analysis on the sample, and presents a result of the diagnosis accomplished.
The analytical phase of the IHC staining process is critical to the diagnosis; thus, errors and wrong evaluations must be proactively prevented from occurring. Several studies have discussed this critical aspect, and a general method adopted to ensure the quality of analysis include: comparing results with other reports, consulting experts for review/evaluation and intradepartmental discussions. However, there is a new technique, PRS product, which ensures that quality diagnosis and results are produced.
Process Record Slide product is the idea of PRS, it incorporates a control and calibration system in the staining process. Traditionally, the IHC staining process does not in any way determine the efficacy of the tissue sampled, the sample-reagents or a true positive result. It basically leaves these parameters to the four-domain model for diagnosis, which is laden with several potholes. These domains, which include cognitive, communicative, normative, and medical conduct domains utilized by clinical pathologist inform at different times the results of IHC staining.
Some major shortcomings of the use of these domains are the reliance on context based interpretations of results, on known observations which have the capacity of masking other important clues, and fatigue which can affect the clinical pathologist reasoning. Thus, the need to include in the staining process a control which shows at every stage of the staining process the expected outcome.
The PRS product which can be used in-situ with the sample under examination, incorporates a control and calibration system in the staining process, such that all shortcomings associated with the diagnosis of the specimen using the domains are eliminated. The World Health Organization once recommended that a control system is developed, and implemented in IHC staining process so that results giving to patients will be confirmed and credible.
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