CHAPTER 3 Safety Procedures and Quality Control INTRODUCTION T his chapter is designed to formalize what should be considered the minimum procedures for safety and quality control in flow cytometry and image analysis. Quality control was once the final process in manufacturing and process control, as well as the last hurdle faced by scientists as technology became more complex and more decisions were automated. Times have changed: without clear guidelines, well-documented procedures, and certified reagents, it is no longer possible to satisfy the relevant certification authorities. As a result, quality control must now be considered a primary rather than secondary objective. For clinical laboratories, where results are used directly for patient evaluation, diagnosis, and treatment, there can be no room for error or for poorly documented assay systems. Methods must be detailed and clearly documented, reagents must conform to strict standards, and issues such as reagent expiration dates must be considered. In a research laboratory, the same strict guidelines will ensure quality results. Moreover, in the past several years, as more decisions have come to be made based upon results of tests run on semiautomated high-technology instruments, instrument and reagent manufacturers have changed their practices as they have faced increasing regulation in the manufacture of their products. Issues covered in this chapter include the historical basis for quality control and the scientific rationales that have driven changes in quality control procedures. Examples of quality control monitoring procedures are suggested in UNIT 3.1 and sample graphs for use in the laboratory are provided in UNIT 3.2. UNIT 3.3 presents techniques for testing the aerosol containment of cell sorters, to help minimize biohazards for workers engaged in sorting potential human pathogens. With the continuing increase in the sorting of viable human cells, it is important for cytometrists to be aware of the potential dangers. These procedures should be employed in all laboratories where such work is done, and every cytometry technician should be required to read this unit before being asked to sort viable human material. It should also be kept in mind that pathogens are not the only potential danger. Many commonly used fluorescent dyes and biological reagents are hazardous as well (UNIT 3.4). UNIT 3.5 presents an easy and inexpensive alternative method of detecting aerosol contamination that produces immediate results. A simple suspension of a commercially available resin which fluoresces orange is run like a normal sample for sorting. Contamination is detected by visualization with a black light source and by examination of slides under a fluorescent microscope. Knowledge of microbiology is not needed. Safety in the laboratory is an area of increasing concern for workers and regulators alike. Many of the reagents and fluorochromes encountered in cytometry are toxic, carcinogenic, mutagenic, and/or teratogenic; new materials with undetermined health and safety properties appear constantly. UNIT 3.4 outlines basic minimal safety concerns and procedures for laboratory workers: chemical storage, appropriate facilities, and personal protective equipment. Extensive tables list known hazards for laboratory chemicals, chemical incompatibilities, and chemical resistance of commonly used laboratory gloves. Protocols outline disposal methods for a number of hazardous chemicals and biological stains, decontamination methods, and detection methods for verification. The Literature Cited contains a lengthy list of reference texts on various aspects of laboratory safety. Safety Procedures and Quality Control Contributed by J. Paul Robinson Current Protocols in Cytometry (2002) 3.0.1-3.0.2 Copyright © 2002 by John Wiley & Sons, Inc. 3.0.1 Supplement 19 As the chapter expands, an attempt will be made to keep users of cytometry-related instrumentation abreast of the latest regulations, quality control procedures, and methods for monitoring these procedures in both research and clinical environments. Particular emphasis will be laid on current quality control requirements for clinical cytometry. J. Paul Robinson Introduction 3.0.2 Supplement 19 Current Protocols in Cytometry
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