For the last 25 years, I have been the director of different cytogenetic laboratories. Like most directors, I started out in academia for my American Board of Medical Genetics fellowship, but then moved on to various commercial laboratories for the next 20 years, and now currently to consulting for different genetic laboratories, both commercial and academic. After all these years, I realize that my daily work consists of two main tasks, signing out cytogenetic cases and managing the clinical laboratory. I wrote my first book, Cytogenetic Abnormalities, Chromosomal, FISH and Microarray‐Based Clinical Reporting, published by Wiley Publishers in 2014, to reflect all the information that I have learned in signing out cases throughout my career. In this book I want to focus on the other aspects of my laboratory duties, namely, laboratory management. Managing or directing a lab requires vastly different skills than what we learn as scientists who need to perform, review, and interpret cytogenetic laboratory results. As scientists, we generally receive little training in the field of management, let alone laboratory management. As geneticists, we rely on our scientific knowledge base and experience in genetic procedures to perform and sign out test results. We acquire those skills after years of working in the laboratory in graduate school and postdoctoral programs.

However, laboratory management uses other skills that we usually learn “on the job.” We learn that to be a good director or manager, we need to be good at interpersonal relations, organization, and time management. We learn to be supportive of the laboratory staff yet be good disciplinarians when performance is not acceptable. We learn to be innovative and strive to be as productive as possible. We learn to be conscious of interpreting patient results and performing genetic analyses with complete accuracy, yet to also be aware of the “bottom line” in order to be within a specific budget. It is a balancing act that we must perform daily and get right every time. Genetic results require 100% accuracy in diagnostic testing as well as being business savvy to be always within a budget; otherwise, our jobs may be in jeopardy.

For these reasons, I decided to write this book on laboratory management. I know what most lab directors and managers face with regards to “running a lab.” So I want to share as much as possible to make life easier for those just starting out, as well as for labs that can use ways to improve their laboratory processes to meet the demands of patient care and their institution’s requirements.

One of the most important things I have learned in management skills (from my father actually) is that as a director or manager of a laboratory or department, one does not manage people; instead, one manages a laboratory or department, and one guides or leads people. There are many different management styles for leaders or leadership. My style is to engage the staff in the processes and procedures of the laboratory and to provide the tools necessary to empower the staff to do their work correctly and efficiently and as independently as possible. I am often the most vocal cheerleader in the laboratory, supporting the staff as best I can in order to give them the assistance and encouragement they need to do their work well and simultaneously enjoy it. Happy employees are generally the most productive employees. By keeping good employees happy in their job, they also tend to have a greater sense of loyalty to their leaders and will support decisions made by the managers. Throughout the years, I have enjoyed great relationships with my present and past employees and companies by keeping a positive demeanor in the laboratory and knowing that I am part of the laboratory team, not above it.

After all these years, I am also aware of some of the possible mistakes that can be made. There is no room for sentimentality as a lab director or manager. Being too hard a leader can cause resentment or shutting down communication between staff and leader of the lab. However, being too soft a leader can be as difficult as being too hard on staff. Staff will certainly take advantage of a leader who is too sympathetic when given the chance. I also know that stress on the job often comes, not necessarily from the daily operations of the laboratory, but often from the demands placed on the directors from those who are higher in the organization hierarchy. It is so easy to feel that as the director of a genetics laboratory, we know best how to run the department, and no one knows better than we do about the testing we perform. However, that often creates conflict with those who place demands on us that differ from our own beliefs in how to direct the laboratory. So how do we resolve these conflicts? That is exactly what I have been analyzing during my years as a laboratory director.

I do know that being too vested in the decisions of the laboratory can be as detrimental as being too aloof when handling conflicting objectives, that is, what is imposed on us versus what we believe. Being so sure of oneself and one’s decisions can lead to arrogance and stubbornness, which often are not in the best interests of the laboratory, its processes, and staff. So this is truly a balancing act that either leaves one feeling elated when it works well or too stressed or “burned‐out” when it does not.

In this book, I am providing information on various topics in laboratory management for those of us who are continually trying to improve ourselves and our laboratories. This book has gray and boxed sections for CAP guidelines, and condensed ACMG guidelines, and other boxes for lists of information for easier reading.

The first section of the book focuses on best practices for laboratory operations, which contains chapters on quality and safety processes that are common in cytogenetic labs; reagent lists and an SOP on reagent verification for clinical use; quality control, quality assurance, and quality improvement SOP’s that are needed for College of American Pathologists (CAP) and Clinical Laboratory Improvement Act (CLIA) regulatory agencies; and ways to perform both internal and external proficiency tests, such as for CAP. This section also includes ways to prepare for a CAP inspection, to “pass with flying colors,” by giving tools on how to make an inspection go smoothly and provide the necessary information to inspectors. This section also discusses calibration verification and how it is used in a cytogenetics laboratory, especially on how it pertains to deriving FISH cutoffs for DNA probes and how to keep up to date with this process, since it is a CAP requirement.

More relevant information to laboratories regarding other aspects of laboratory management, including designing laboratory developed tests (LDTs), FDA guidelines for LDTs, and preclinical validation studies, is also provided in this section. We know in cytogenetic testing that we need to have all of our tests validated, with the exception of FDA‐approved tests, which only need the performance characteristics confirmed in the laboratory when tests are performed “on‐label.” Since most cytogenetic tests are not FDA approved or are FDA‐approved tests that are “off‐label,” these tests need proper validations performed before clinical use, with a validation plan and SOP and a validation report. Therefore, I have provided templates and example validation plans and reports that can be downloaded for laboratory use.

The second section of the book describes best practices for staffing and training employees in a cytogenetics laboratory. So much of what we do as directors are ensuring that staff are trained, competent, and efficient in their work. That requires a lot of dedication to the staff and a great deal of paperwork to document their performance in the laboratory. My goal here is to provide template benchmarks and documents, including spreadsheets that can be downloaded so that laboratories do not have to generate new forms for each item required, and to also provide the necessary steps for each test to prove training and competency of staff. I have also provided template “Training Programs” for cytogenetic and molecular genetic technologists (that comply with California standards—currently the most stringent of all the states in training and licensing technologists).

A chapter on Six Sigma for process improvement is also provided. Six Sigma is a sophisticated approach to improving processes, which applies well to cytogenetic laboratories. As a certified “green belt” in Six Sigma and Lean Processes, I give examples of how to improve processes in a business manner that organizations like to see for the purpose of being able to buy essential equipment, increase staffing where needed, and improve efficiency in a laboratory.

The third section of this book focuses on standard operating procedures. This is not an attempt to be comprehensive of all the possible procedures in every aspect of cytogenetic testing, since there are many other sources for this information. Rather, I am putting together common practices used in most laboratories, mainly to offer prototypes of each procedure as templates which can be used as is or with one’s own variations. These SOPs will help labs acquire procedures that can be “downloaded” into their laboratory, which can then be modified for one’s own use, rather than starting from scratch. As a result, a director’s job will be much easier by being able to use these SOPs in the correct format for regulatory purposes and to provide the necessary steps for each SOP that cytogenetic laboratories need. We most often focus our SOPs on each individual step of the process, but we also need to understand the format that is required and include the pre‐ and postanalytic steps of processes which may be overlooked. Also, many labs do not process all sample types or all the various tests that are available. In that case, when adding new tests, it is often hard to start writing a new SOP in the correct format from scratch. This is true especially for microarrays, where there is relatively little information on SOPs for this type of testing. I have not included a detailed microarray assay for this very reason. I have found no SOP to date that applies equally well for any laboratory since I believe there is too wide a variety of processes that can be used in this technology. Thus, there is no real standard SOP as yet to share with laboratories.

My goal is that when you read this book, it will be a handbook for you, and you will use it for practical purposes. I have provided many spreadsheets, forms, and SOP’s that can be downloaded, saving time in developing these documents on your own. I also hope that this book can give ideas on how to save time, use good time management and organization, help enhance management skills, and improve your laboratory processes. Please feel free to contact me if you have information you would like to share on this topic.