Nongynecological Cytology Practice Guidlines
Prepared by the American Society of Cytopathology, Cytopathology Practice Committee.
Adopted by the ASC Executive Board, March 2, 2004
I.A. Purpose, Intended Audience, and Limitations
Practice guidelines are used by diverse segments of the medical community to define and communicate standards of performance and care. To date, the American Medical Association has catalogued nearly 2,000 clinical practice guidelines or equivalent documents.3 An additional source on practice Guidelines is the web site www.guideline.gov (National Guideline Clearinghouse) that is sponsored by the Agency for Health Care Research and Quality in partnership with the American Medical Association and the American Association of Health Plans.
The Nongynecological Cytology Practice Guideline is a document for laboratories and is intended for use primarily by cytologists – pathologists and cytotechnologists – who perform non-gynecologic cytology analyses and report their findings to clinicians. It is not intended to represent the standard of care for use in medico legal proceedings. Thus, this document focuses on laboratory processes and related topics such as techniques of sample procurement, slide staining and analysis, and cytology laboratory management. Although this guideline is intended for use by laboratorians, clinicians, and patients, others involved in healthcare may find this document to be a resource when correlating nongynecological cytology results with clinical care decisions. Information that is unique for specific organs, organ systems or body sites is contained in sections entitled supplementary information.
The Nongynecological Cytology Practice Guideline is not intended for use as or a substitute for a procedure manual for cytology technical protocols. Readers may use references cited at the end of this Guideline, or other sources, for information such as preparation methodology or staining formulations.
The process of creating a guideline represents consensus building within a specialty with subsequent endorsement by national professional organizations. In light of rapidly evolving science and technology, a guideline devoted to nongynecological cytology requires timely review and revision. This guideline serves not as a specific blueprint or set of dictates, but as a device to assist standardization and continuous quality improvement efforts. It is with this understanding that the American Society of Cytopathology promulgates this Nongynecological Cytology Practice Guideline.
I.B. Context and Scope
The emphasis of this guideline is on nongynecological cytology specimen procurement, analysis, reporting and management. Specific microscopic criteria for interpretation are not included since these are well described in textbooks, symposia and workshops. A detailed analysis of related clinical topics such as patient care algorithms for follow up of abnormal nongynecological cytology results are also beyond the scope of this document.
An important general limitation is that this guideline, in many respects, is applicable for laboratories in the United States that are subject to the provisions of the Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88) and for laboratories that participate in the Laboratory Accreditation Program of the College of American Pathologists (CAP).4,5 Many of the elements of the guideline are defined or specified in the CLIA regulations and/or in the CAP laboratory accreditation checklists. In the text of this guideline the word “must” is used to distinguish regulatory requirements from other best practice recommendations.
I.C. Variability of Practice
This document highlights procedural and interpretive areas where there are variations in practices, and areas where there is consensus for “best practices”. Where the literature is conflicting, absent, or consists only of case reports rather than more comprehensive studies, this document describes different laboratory practices.
1 Institute of Medicine (IOM), Committee on Clinical Practice Guideline. Guideline for Clinical Practice – From Development to Use. Field MJ, Lohr KN, (eds.). Washington, D.C: National Academy Press; 1992, p 8.
4 Department of Health and Human Services, Health Care Financing Administration, Public Health Service, 42 CFR 405 et seq, 57 FR 7002-7186, February 28, 1992 [revising regulations applicable to laboratories and implementing provisions of the Clinical Laboratory Improvement Amendments of 1988, P.L. 100-578]
5 College of American Pathologists. Commission on Laboratory Accreditation, www.cap.org