Digital pathology: A regulatory overview

Laboratory Medicine

Volumn 42, Issue 10, 2011, Pages 587-591

  Lange, Holger ^a  

^a Flagship Biosciences LLC   (United States)

Author keywords

CAP; CLIA; Digital pathology; FDA; Regulations

Indexed keywords

ARTICLE; CLINICAL LABORATORY; CLINICAL PROTOCOL; COLLEGE AMERICAN PATHOLOGIST; DEVICE APPROVAL; DIGITAL COMPUTER; DIGITAL PATHOLOGY; DRUG MANUFACTURE; FLUORESCENCE IN SITU HYBRIDIZATION; FOOD AND DRUG ADMINISTRATION; HEALTH CARE INDUSTRY; HUMAN; IMAGE ANALYSIS; LABORATORY AUTOMATION; LABORATORY TEST; MEDICAL DEVICE MANUFACTURER; MEDICAL INSTRUMENTATION; MEDICAL SOCIETY; MEDICAL TECHNOLOGY; PATHOLOGIST; PATHOLOGY; TELEMEDICINE; TELEPATHOLOGY; VALIDATION PROCESS;

EID: 81455143060     PISSN: 00075027     EISSN: 19437730     Source Type: Journal    
DOI: 10.1309/LMA2M9NQQF0ZCVHC     Document Type: Article

References (8)

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2. Centers for Medicare and Medicaid. Code of Federal Regulations Part 493 Laboratory Requirements. October 2004.
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4. Hammond ME, Hayes DF, Dowsett M, et al. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for immunohistochemical testing of estrogen and progesterone receptors in breast cancer (unabridged version). Arch Pathol Lab Med. 2010;134:e48-e72.
5. Fitzgibbons PL, Murphy DA, Hammond ME, et al. Recommendations for validating estrogen and progesterone receptor immunohistochemistry assays. Arch Pathol Lab Med. 2010;134:930-935.
6. Laboratory General Checklist. College of American Pathologists, June 2010.
7. Anatomic Pathology Checklist. College of American Pathologists, June 2010.
8. Kaplan, K. Development of CAP Standards for Digital Pathology that would be important for CAP Accreditation of Pathology Labs as we transition into a Digital Era. Pathology Visions Conference, October 2010.