Specimen Adequacy

Evaluation of specimen adequacy is considered by many to be the single most important quality assurance component of the Bethesda system. Prior to the 2001 Bethesda system (TBS), criteria for determining adequacy were based entirely on expert opinion and a few available studies in the literature. Laboratory implementation of some of these criteria was shown to be poorly reproducible. The 2001 Bethesda adequacy criteria were based on published data to the extent possible and were tailored to both conventional and liquid-based preparations. For this third edition of the TBS atlas, data and clinical experience regarding specimen adequacysince 2001 were reviewed, leading to the offering of additional guidance for special situations, such as assessing cellularity in specimens obtained from postradiation patients, interfering substances and human papillomavirus testing

Preanalytics and Precision Pathology: Pathology Practices to Ensure Molecular Integrity of Cancer Patient Biospecimens for Precision Medicine.

Biospecimens acquired during routine medical practice are the primary sources of molecular information about patients and their diseases that underlies precision medicine and translational research. In cancer care, molecular analysis of biospecimens is especially common because it often determines treatment choices and may be used to monitor therapy in real time. However, patient specimens are collected, handled, and processed according to routine clinical procedures during which they are subjected to factors that may alter their molecular quality and composition. Such artefactual alteration may skew data from molecular analyses, render analysis data uninterpretable, or even preclude analysis altogether if the integrity of specimen is severely compromised. As a result, patient care and safety may be affected, and medical research dependent on patient samples may be compromised. Despite these issues, there is currently no requirement to control or record preanalytical variables in clinical practice with the single exception of breast cancer tissue handled according to the guideline jointly developed by the American Society of Clinical Oncology and College of American Pathologists (CAP) and enforced through the CAP Laboratory Accreditation Program. Recognizing the importance of molecular data derived from patient specimens, the CAP Personalized Healthcare Committee established the Preanalytics for Precision Medicine Project Team to develop a basic set of evidence-based recommendations for key preanalytics for tissue and blood specimens. If used for biospecimens from patients, these preanalytical recommendations would ensure the fitness of those specimens for molecular analysis and help to assure the quality and reliability of the analysis data