Standard Document
Second Edition
Quality Management Systems

CLSI GP23

Nongynecological Cytology Specimens: Preexamination, Examination, and Postexamination Processes

This document offers expert advice for cytology laboratories to develop preexamination, examination, and post-examination processes and procedures for managing nongynecological cytology specimens.

 

November 24, 2014
MariBeth Gagnon, MS, CT(ASCP)HTL

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Abstract

Clinical and Laboratory Standards Institute document GP23-A2—Nongynecological Cytology Specimens: Preexamination, Examination, and Postexamination Processes; Approved Guideline—Second Edition was developed for use by clinical and laboratory personnel responsible for the collection and processing of nongynecological cytology specimens. This guideline describes the path of workflow (preexamination, examination, and postexamination processes) for nongynecological cytology specimens.

Overview of Changes

This guideline revises GP23-A using the QMS model described in CLSI document QMS01, and the path of workflow that would be found in a nongynecological cytology laboratory. In addition to format changes and updated techniques described within this document, this guideline contains comprehensive QA measures and a patient safety checklist to help laboratories develop quality indicators to monitor and assess cytology laboratory performance.

Scope

This guideline provides recommendations for cytology laboratories to use in developing preexamination, examination, and postexamination processes and procedures for nongynecological cytology specimen management. 

This document does not address issues related to the interpretation of the slide preparation. Cervicovaginal cytology is addressed in CLSI document GP15 and fine needle aspirate cytology is addressed in CLSI document GP20.

Product Details
GP23A2E
1-56238-983-1
64
Additional Details

The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.

This document is available in electronic format only.

This archived document is no longer being reviewed through the CLSI Consensus Document Development Process. However, this document is technically valid and because of its value to the laboratory community, it is being retained in CLSI’s library.

Authors
MariBeth Gagnon, MS, CT(ASCP)HTL
Jennifer A. Ross, BAppSc, CT(ASC), CT(IAC)
Terri Broxmeyer, BA, SCT(ASCP)
Sharon Crafter, MLT, CT(ASCP), BA
Leza N. Gallo, MD
Cathy A. Mitchell, BS, SCT(ASCP), CIAC
Ann T. Moriarty, MD
Ramona R. Nelson, BS, HT/HTL(ASCP)
Joan S. Rossi, MA, CT(ASCP)CM
Dennis Sevilla, PhD, CT(ASCP), MBA
Behdad Shambayati, MSc, CSci, FIBMS
Debra L. Sydnor, BS, CT(ASCP)IAC
William D. Tench, MD
Abstract

Clinical and Laboratory Standards Institute document GP23-A2—Nongynecological Cytology Specimens: Preexamination, Examination, and Postexamination Processes; Approved Guideline—Second Edition was developed for use by clinical and laboratory personnel responsible for the collection and processing of nongynecological cytology specimens. This guideline describes the path of workflow (preexamination, examination, and postexamination processes) for nongynecological cytology specimens.

Overview of Changes

This guideline revises GP23-A using the QMS model described in CLSI document QMS01, and the path of workflow that would be found in a nongynecological cytology laboratory. In addition to format changes and updated techniques described within this document, this guideline contains comprehensive QA measures and a patient safety checklist to help laboratories develop quality indicators to monitor and assess cytology laboratory performance.

Scope

This guideline provides recommendations for cytology laboratories to use in developing preexamination, examination, and postexamination processes and procedures for nongynecological cytology specimen management. 

This document does not address issues related to the interpretation of the slide preparation. Cervicovaginal cytology is addressed in CLSI document GP15 and fine needle aspirate cytology is addressed in CLSI document GP20.

Additional Details

The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.

This document is available in electronic format only.

This archived document is no longer being reviewed through the CLSI Consensus Document Development Process. However, this document is technically valid and because of its value to the laboratory community, it is being retained in CLSI’s library.

Authors
MariBeth Gagnon, MS, CT(ASCP)HTL
Jennifer A. Ross, BAppSc, CT(ASC), CT(IAC)
Terri Broxmeyer, BA, SCT(ASCP)
Sharon Crafter, MLT, CT(ASCP), BA
Leza N. Gallo, MD
Cathy A. Mitchell, BS, SCT(ASCP), CIAC
Ann T. Moriarty, MD
Ramona R. Nelson, BS, HT/HTL(ASCP)
Joan S. Rossi, MA, CT(ASCP)CM
Dennis Sevilla, PhD, CT(ASCP), MBA
Behdad Shambayati, MSc, CSci, FIBMS
Debra L. Sydnor, BS, CT(ASCP)IAC
William D. Tench, MD