Archives of pathology & laboratory medicine
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Arch. Pathol. Lab. Med. · Nov 2011
ReviewCollege of american pathologists proposal for the oversight of laboratory-developed tests.
The US Food and Drug Administration (FDA) announced it will exercise authority over laboratory-developed tests (LDTs). Laboratory-developed tests have traditionally been developed and offered in laboratories as a service to patients and regulated under the Clinical Laboratory Improvement Amendments of 1988 (Clinical Laboratory Improvements Act). Laboratories now face potential dual regulatory oversight from both the Centers for Medicare and Medicaid Services (CMS) and the FDA. The College of American Pathologists (CAP) constructed a proposal to minimize redundancy of agency oversight and burden to laboratories. Modifications to the proposal continue while the laboratory community awaits release of the guidance documents that will stipulate FDA requirements. ⋯ The College of American Pathologists is a leader in laboratory quality and has unique insights into the benefits and risks to patients presented by LDTs. Continued dialog with officials from the FDA and CMS will promote public and private collaborative efforts to assure innovation of diagnostic testing, public information, and patient safety for clinical diagnostic testing.
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Merkel cell carcinomas are rare cutaneous neoplasms that are known to metastasize to various mucosal sites, including the genitourinary tract. Primary Merkel cell carcinomas of the genitourinary tract are extremely rare and may be mistaken for other more common carcinomas of the genitourinary tract, including urothelial carcinomas and prostatic carcinomas. ⋯ Accurate diagnosis is crucial for appropriate clinical treatment. The discovery of the Merkel cell polyomavirus as a possible causative agent adds a new dimension in the understanding of the pathogenesis and diagnosis, and possible targeted therapies for this tumor.
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Interest in pathologist-performed ultrasound-guided fine-needle aspiration is increasing. Educational courses discuss clinical ultrasound and biopsy techniques but not ultrasound physics and instrumentation. ⋯ Ultrasound physics and instrumentation are the foundations of clinical ultrasound. The key physical principle is the piezoelectric effect. When stimulated by an electric current, certain crystals vibrate and produce ultrasound. A hand-held transducer converts electricity into ultrasound, transmits it into tissue, and listens for reflected ultrasound to return. The returning echoes are converted into electrical signals and used to create a 2-dimensional gray-scale image. Scanning at a high frequency improves axial resolution but has low tissue penetration. Electronic focusing moves the long-axis focus to depth of the object of interest and improves lateral resolution. The short-axis focus in 1-dimensional transducers is fixed, which results in poor elevational resolution away from the focal zone. Using multiple foci improves lateral resolution but degrades temporal resolution. The sonographer can adjust the dynamic range to change contrast and bring out subtle masses. Contrast resolution is limited by processing speed, monitor resolution, and gray-scale perception of the human eye. Ultrasound is an evolving field. New technologies include miniaturization, spatial compound imaging, tissue harmonics, and multidimensional transducers. Clinical cytopathologists who understand ultrasound physics, instrumentation, and clinical ultrasound are ready for the challenges of cytopathologist-performed ultrasound-guided fine-needle aspiration and core-needle biopsy in the 21st century.
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Acute lung injury and acute respiratory distress syndrome are significant causes of pulmonary morbidity and are frequently fatal. These 2 entities have precise definitions from a clinical standpoint. Histologically, cases from patients with clinical acute lung injury typically exhibit diffuse alveolar damage, but other histologic patterns may occasionally be encountered such as acute fibrinous and organizing pneumonia, acute eosinophilic pneumonia, and diffuse hemorrhage with capillaritis. ⋯ Acute lung injury remains a significant cause of morbidity and mortality. The pathologist should be aware of histologic patterns of lung disease other than diffuse alveolar damage, which are associated with a clinical presentation of acute lung injury. Identification of these alternative histologic findings, as well as identification of potential etiologic agents, especially infection, may impact patient treatment and disease outcome.
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Arch. Pathol. Lab. Med. · Jan 2010
ReviewHigh-resolution computed tomography screening for lung cancer: unexpected findings and new controversies regarding adenocarcinogenesis.
Recent advances in human imaging technologies reawakened interest in lung cancer screening. Although historic and current preliminary and noncontrolled studies have not shown a decrease in lung cancer mortality in screened populations, many explanations have been proffered while the lung cancer community awaits the results of several large controlled population studies. ⋯ The current adenocarcinogenesis model is probably valid for many but not all lung adenocarcinomas. Screening data combined with radiographic and pathologic studies suggest that not all lung adenocarcinomas are clinically aggressive, and it is uncertain whether all aggressive adenocarcinomas arise from identified precursors.