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  Seeing big picture yields big lab
  improvements

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cap today

October 2005
Recommended Reading

Ed Finkel

Clinical laboratory directors and supervisors will find a wealth of practical information written in easy-to-understand language in the new manual, Quality Management in Clinical Laboratories: Promoting Patient Safety Through Risk Reduction and Continuous Improvement.

Published by the CAP and released last month at the CAP ’05 annual meeting, the manual encourages laboratory managers to take a step back and look at the big picture, says Paul Valenstein, MD, editor of the manual and a pathologist at St. Joseph Mercy Hospital, Ann Arbor, Mich.

“In the day-to-day grind of putting out fires and trying to make the lab as productive as possible,” he says, “some laboratory managers lose sight of our fiduciary duty to patients to ensure quality.”

“We’re comfortable with the routine oversight of quality, such as reviewing proficiency test results and signing off on procedures,” he says. “That is a great first step, but my hope is that laboratory directors and supervisors will develop a broader sense of their role. This manual will help managers recognize a wide range of quality vulnerabilities and take specific, practical steps to alleviate them.”

The purpose of the manual is to help managers produce the best possible quality outcomes for customers, Dr. Valenstein says. “As managers we are asked to guarantee an outcome that’s dependent on the work of others. This challenge leaves many managers uncomfortable, given the fact that the people we depend upon will inevitably make errors,” he says. “Every single component of our laboratory—humans, reagents, equipment—can fail. And given enough time, they will.”

Contributing author Bruce Jones, MD, of Henry Ford Health System, Detroit, praises Dr. Valenstein for assembling a usable, readable book on an important subject. “I’ve been a pathologist in a variety of management positions for 20-some years,” says Dr. Jones, who wrote a section on using customer feedback. “I’ve taken management courses for health care individuals, I’ve read a variety of management textbooks, and this is one of the most practical and clearly written resources that a lab manager could ever have.”

He likes the book’s liberal use of examples. “I’ve read textbooks where they present a concept or a management idea,” he says. “After you’ve read their discussion of it, you’re kind of left with, ‘OK, that’s interesting, but what do I actually do with it?’ This book takes you right through that and points out how these concepts can be used.”

Such management concepts are not commonly taught in medical school, says Dr. Jones. “Fortunately, the folks who oversee pathology residency training have incorporated more and more over the past years an emphasis on residents receiving laboratory management training, to a better degree than was done in the past,” he says. He himself teaches a course in laboratory management for residents at Henry Ford. “I am going to liberally use the contents of this book for that course, using the examples as points of discussion,” he says.

Ronald Sirota, MD, of Advocate Lutheran General Hospital, Park Ridge, Ill., points to the manual’s thoroughness and readability. “Paul did not create a 1,700-page encyclopedia of quality assurance that could not be easily digested. This is an accessible work,” says Dr. Sirota, who contributed a section on human error and patient safety.

“The book is a valuable contribution because it is a synopsis of quality assurance, covers a great deal of material, and is written in a style that can be comprehended by anybody in the pathology community. It has a unique focus on patient safety, which has been highlighted over the past 10 years as a very important but somewhat underemphasized part of quality assurance.”

After a synopsis of what is and is not in the book, the manual dives into case studies based on actual events but with names and locations changed. The purpose of the case studies is to drive home several points in memorable ways, Dr. Valenstein says. “First, that laboratory quality failures have consequences—patients can be harmed, care can be delayed, money can be wasted. Second, that quality failures take many forms,” he says. “It’s more than just instruments producing inaccurate results. These case studies raise many questions and give readers a sense of the scope of quality problems: This nut is more difficult to crack than it first appears.”

The vignettes—which cover issues ranging from human error and communication lapses to instrument failure and fraud—are all worthy of review and discussion for any lab, Dr. Jones says. For each one, managers should ask themselves: “What is relevant in this example to our environment?” he says, adding, “It grabs your attention, it piques your interest, and then he gets into the nitty-gritty of what a manager would want to know about how to address these types of management issues.”

Chapter No. 3 takes a step back from the laboratory setting and provides what Dr. Valenstein describes as a “methodological tool kit,” a look at quality management models that have worked in other fields and how they might apply to the clinical laboratory. “As unique as we might think we are, others have dealt with the same spectrum of problems we encounter,” he says.

The section explores such methods as statistical process control, total quality management, the Toyota/ Lean production system, and failure mode effects analysis. “There are hundreds of management consultants out there who have adopted these terms and extended them and changed them,” Dr. Valenstein says. “They don’t have very clear meaning today. But if you go back to look at the original writing and the original method, and see how they were originally applied in particular industries, there are distinct approaches to quality management, which turn out to be complementary.”

Dr. Sirota agrees: “Lean production model, failure mode effects analysis, and root cause analysis are very contemporary and probably not well understood by the pathology community simply because they are new.”

Yet they should get more attention in laboratory settings, Dr. Jones says. “Each one of these, all by themselves, in most laboratories, would be significant items for discussion and review, with respect to, how can we apply this in our laboratory?” he says. The chapter provides “a list of key points with respect to error reduction and prevention. Each one is a pearl,” he adds.

The section on human error, which Drs. Valenstein and Sirota co-wrote, is a new contribution to the field of patient safety in laboratory medicine, Dr. Sirota says. “We’re applying to laboratory medicine concepts that have been known and applied for a long time in other industries and venues,” he says. “There is a tremendous amount known about human error and why people make mistakes, and these concepts need to be applied to laboratory medicine.” Patient safety, he says, is about reducing the frequency of these errors and protecting patients from the errors that do occur.

The book next turns to laws and regulations related to laboratory management, from federal and state statutes to CAP requirements. “Many laboratory directors do not understand that they have specific legal responsibilities under CLIA ’88,” Dr. Valenstein says. “There are certain minimum regulatory duties CLIA assigns to the laboratory director, and these responsibilities are difficult to fulfill. Recognizing these responsibilities can be a powerful motivator to get serious about quality management.”

The fifth chapter, by far the longest in the book, provides a step-by-step rundown of the types of problems laid out in the case studies—and many more—and talks about how to solve them, Dr. Valenstein says.

“It’s a delineation of what we believe to be the major quality problems in clinical laboratories, how frequently they occur in our industry, and what managers can do about them,” he says. “We talk about things that frequently go wrong, or that go wrong infrequently, but which have major consequences for patients.” These range from ordering the wrong test, to not collecting the test specimen properly, to ordering the right test for the wrong patient because of a labeling error.

And those are just the preanalytic issues. “Problems in laboratories can manifest themselves during any part of the test cycle—before, during, or after the analysis,” Dr. Valenstein says. “For each of those domains, we discuss what we believe to be the most serious problems and what can be done about them. These problems range from reporting critical results to transfusing the wrong blood product.”

The chapter draws heavily on the CAP’s Q-Probes and Q-Tracks experience in generating the necessary reference and benchmarking information, Dr. Jones says. “It’s one thing to measure what you do,” he says. “It’s another thing altogether to get a concept of, where does that performance I just measured stand in the industry?”

Chapter No. 6 walks managers through the process of customizing a quality management program for one’s own laboratory, by learning from customer feedback and quality incidents, Dr. Valenstein says.

“There aren’t many books that deal with this topic, and most of them are too theoretical to be useful. Laboratories are different and often deal with a different set of problems,” he says. Managers should start out by focusing on widely recognized problems, such as specimen identification or analytical errors. “But customer feedback and recurring incidents can focus attention on specific areas that may not raise issues in every laboratory.”

Before delving into how to learn from customers, the chapter examines who laboratories’ customers are, Dr. Jones says. “A lot of people don’t stop and think about that. We have many customers in the laboratory environment, which are discussed one by one.” He says the chapter provides “enough information to point [managers] in the direction of the concerns for each category of customers.”

To address those concerns, laboratory managers should survey their customers and attempt to learn specifics from documented incidents, Dr. Jones advises. “So many laboratories will have a system that accumulates incidents, or complaints,” he says. “They look at them, and file them, and deal with them one by one. But these are a tremendous opportunity and resource for laboratory managers to identify weaknesses and opportunities to improve their services.”

Dr. Jones recalls reading about a then-fledgling computer company called Dell that had regular reviews “of all the repairs they had to pay for of their computer products,” he says. “From that summary, they would immediately go back to their plant or supplier . . . so those issues would then be resolved. This is the same concept, if we would look at these [files] and see them to our benefit, rather than as an annoyance.”

The book’s final chapter provides a guide to creating a “quality management plan” for the laboratory—documenting and codifying the clinical laboratory’s plan for ensuring quality and patient safety. “The most important point is to manage quality risks,” Dr. Valenstein says. “But the fact that you’re doing it isn’t enough. In United States clinical laboratories it is necessary to document what you are doing and describe your approach on paper.” The quality management plan is where risk assessment is documented, as well as what the lab is doing to mitigate risks and promote patient safety. “The plan describes the approaches you’re going to take and the problems you’re going to focus on,” he says.

The chapter supplies three examples of quality management plans for managers to draw from and customize. “They do not have to go out and reinvent the wheel,” Dr. Jones says. “We all have time constraints.”

In Dr. Sirota’s view, that chapter is probably the most useful section of the book. “There it is: the road map for your plan,” he says. “Take a plan, study it, customize it to your particular laboratory services, and you’ll be way ahead of the game.” Of course, the plan is only as good as its implementation. “The earnest implementation of quality assurance plans is what makes them work,” he adds.

Such plans tie back into laws and regulations and the managers’ fiduciary duty to customers, Dr. Valenstein says. “An inspector will want to see these documents,” he says. “The existence of a quality management plan and evidence that it is being applied is one way the outside world can determine whether laboratory directors are fulfilling their role in protecting patients.”

He adds: “Of course, satisfying an inspector isn’t enough. The problem with an external inspection system is that it works only when the first line of defense—the laboratory director—is intact. You can’t inspect your way into quality—it just won’t work. There has to be a mindful, internal emphasis on quality” that the laboratory director and other laboratory managers reinforce every day.

And the quality management plan is a perfect vehicle for stimulating that activity.


Ed Finkel is a writer in Evanston, Ill.

To purchase the book ($65 for members, $95 for nonmembers), call 800-323-4040 option1# (publication No. PUB214).