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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