Quality Management

 
Chair: William DeSalvo HTL(ASCP)

Sonora Quest Laboratory
1255 W. Washington Street
Histology Department
Tempe, AZ 85281
Phone: 602-768-3692

wdesalvo.cac@hotmail.com

The Quality Management Committee formulates and maintains quality control guidelines which pertain specifically to the histology laboratory. This committee maintains a tissue control bank. NSH members can receive the name of someone able to provide a needed control, or members are encouraged to list themselves as a source of control tissue.

Committee Business
Click Here to Join the Committee

2014 Annual Report

Resources & Publications

Histologic Preparations: Common Problems & Their Solutions
The "how to" guide to good slide preparation, Histologic Preparations: Common Problems and Their Solutions, was developed by the Histotechnology Committee of the College of American Pathologists (CAP) in conjunction with the National Society for Histotechnology (NSH). Building on data and images from the NSH/CAP histology quality assurance program, HistoQIP, the book presents photographic examples of well-prepared slides followed by numerous examples of associated problems and their solutions.
Histologic Preparations is a reference text as well as a teaching tool. Written for pathologists, pathology residents, histotechnologists, and histotechnicians as well as histology students, this thorough book contains troubleshooting techniques for the most common artifacts and problems incurred in routine histologic preparations.
Some of the topics covered are fixation and processing; microtomy; frozen sections; H&E and Gram stains; mycobacteria, H pylori, spirochetes, and fungi; and trichrome, reticulin, elastin, basement membrane, mucin, amyloid, and immunohistochemical stains. This book is available through the NSH Marketplace. A discount is available to NSH members.

CLSI Microwave Device Use in the Histology Laboratory; Approved Guideline
Currently under review this document provides recommendations for quality assurances and safety procedures for microwave equipment use, and provides a means to understand and troubleshoot conditions that contribute to variability in microwave-accelerated procedures in human clinical, veterinary, and research histopathology laboratories.  Safety issues unique to microwave instrumentation in histopathology laboratory settings are emphasized.  In addition, the document discusses microwave devise process control, procedure validation, and results verification.  Click here to download the PDF.

Journal of Histotechnology Articles

Quality Issues in Immunohistochemistry
Author: Hector Battifora, Pacific Coast Reference Laboratories, Cypress, CA
Volume 22, 3, pg 169

Annual Symposium/Convention Workshop Handouts
In September of 2010 the 36th Annual Symposium/Convention took place in Seattle, WA.  During this event 3 workshops were presented with useful quality control & quality assurance information.  Click on the workshop title to download their handout.

WS46: Controls in Histopathology: What Can and What Should be Controlled
Presented by Alton D. Floyd
Everyone talks about controls, and certainly inspectors ask about both controls and records during inspections.  There are few recent discussions of control procedures, methods and materials in the literature of histotechnology.  Many laboratories still are primarily dependant on the discussions in Shehan as the primary reference for control techniques and procedures and the sometimes curious demands of laboratory inspectors.  With the dependence of most working laboratories on premixed stains, and the increasing necessity of immunostaining in diagnostic procedures, the laboratory must have an effective and practical set of control procedures to insure quality results.  As slides, blocks and images of specimens are more widely circulated for either education or consultation, verifiable procedures are required.  It is no longer sufficient to simply monitor temperature and service intervals to demonstrate adequate quality assurance of laboratory procedures.  The preparation and use of standards will be described, methods of verifying the characteristics of incoming reagents, and monitoring of shelf life will also be presented.  Particular emphasis will be placed on immunostain control procedures, as well as a detailed look at the procedure elements that must be controlled when a specimen is being prepared for imaging and image analysis.

WS83: Simple & Standardized: Precision Tissue Processing
Presented by William DeSalvo
Are you fed up with having to pick from your bag of “tricks” to rework and manipulate your labs processed tissues samples?  Do you suffer from inconsistent or time consuming Microtomy, variation in staining intensity, difficulty in getting that IHC to work?  All these issues happen more often than they should in the Histology lab of today and create major problems for workflow, waste time and increase cost unnecessarily.  Before you can move to the future LEAN, MEAN and EFFICIENT Histology lab you must step back and rethink and rework the first major and most important step in the histology process, tissue sampling.  This workshop will discuss why standardization of sample size and proper fixation are so important and critical to increasing efficiencies and quality in Histology, while preparing the way for additional process improvements in all aspects of Histology.  Presented will be a method for gross sampling and a guide for fixation that can be used with conventional or rapid processing and associated LEAN processes.  Time will be provided for open discussion and participant interaction is encouraged.

WS#86 Validation and Quality Control for Immunohistochemistry
Presented by Tim Morken and Patsy Ruegg
Understanding how to perform quality control for variables in immunohistochemistry is essential in order to allow a laboratory to offer trustworthy results and proper Validation of reagents and methods is the first step towards excellent Quality Control.  This presentation will cover Validation and Quality Management methodology in detail and show how Validation and Quality Management fit into the Quality Assurance framework.  The steps of validation and quality control for clinical labs will be related to U.S. Federal Clinical Laboratory Improvement Amendment regulations (CLIA) and accreditation checklists from the CLIA-deemed Agencies College of American Pathologists (CAP) and Joint Commission (JC, or JCAHO) as well as the guidelines published by the Clinical Laboratory Standards Institute (CLSI). Additionally the presentation will cover how validation and quality control are handled in industry settings under the U.S. Food and Drug Administration (FDA) Good Laboratory/Manufacturing Practices (GLP/GMP) as well as ISO quality system requirements including simple statistics used to compare known to unknown antibodies or other reagents.