College of American Pathologists
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  President’s Desk Column


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Like yeast to the dough

January 2005
Mary E. Kass, MD

There’s not much hope for a batter without a leavening agent. You can beat that ball of flour and water until the cows come home, but dough without yeast will just lay there, one big blob of unrealized potential.

A tiny scoop of yeast, though, will awaken the inert mass and change that batter to bread. Human endeavors are much the same. A handful of clear thinkers can be like yeast to the dough; one or two leaders can transform a situation.

At Maryland General Hospital, the leavening agents were laboratory workers who were tenacious in exposing hidden quality control problems in HIV and hepatitis testing. Although their complaints had fallen on deaf ears, they persisted. And if, as we expect, the new Congress passes whistleblower protection legislation this year, the new law will be a part of their legacy.

Those of us on the front lines for the College put in some long days when problems at the Maryland General Hospital laboratory were uncovered last year. Laboratory Accreditation Program chair Ron Lepoff, MD, and I testified before legislative committees in the U.S. House and the Maryland state senate. We met with Maryland legislators and regulators, federal authorities, and representatives of the Joint Commission on Accreditation of Healthcare Organizations. In each instance, we worked to deconstruct the scenario, stretch it out, get to the bottom of it. How could this happen? How could we make sure it wouldn’t happen again?

Within the CAP accreditation program, Dr. Lepoff and his team examined our fundamental assumptions. What are the visceral cues, the off-checklist signs that a laboratory is (or is not) well run? A few conclusions emerged:

  • In a well-run laboratory, the pathologist director is enmeshed in the fabric of day-to-day operations. The single best predictor of trouble in a laboratory is a passive, uninvolved pathologist director.
  • A well-run laboratory is a comfortable, productive place where people communicate freely. Does the staff interact easily with the laboratory director? With one another? Is there an atmosphere of constructive criticism and easy exchange? Is this a team that is always trying to be better?
  • The staff in a well-run laboratory is committed to meaningful quality assurance.

We have talked about the first two points before; this month I would like to address the third.

The purpose of quality assurance is to improve patient care and reduce error. Yet a quality assurance plan will sometimes identify preanalytic or postanalytic error without suggesting a plan to correct it. Some staff members might be charged with collecting data; others might be charged with analyzing it. But if everyone isn’t charged with correcting the problems, the quality assurance plan is not an agent of change.

The day has passed when a laboratory director could claim lack of authority for the performance of nonlaboratory staff. If nurses, emergency room staff, or operating room personnel are mislabeling specimens, not drawing them correctly, or storing them improperly for transport, their mistakes can hurt the patient. Teaching them the right way is our responsibility.

Many laboratory errors actually happen outside the laboratory. As a consequence of the events in Maryland, we are now seeing a regulatory trend toward holding laboratory directors responsible for all laboratory error, and for all preanalytic, analytic, and postanalytic quality assessment. Pathologists should be aware that the implications of this trend are that participation in quality improvement measures to reduce error outside the laboratory will not be sufficient; quality improvement results will have to be documented.

Laboratory directors have always been expected to work with other departments for quality improvement in the management of laboratory specimens. Now laboratory directors must consider that failures outside the laboratory that impair or impede the quality assurance plan for the laboratory are part of the responsibility of the laboratory director. This may generate a shift in emphasis on the part of federal regulators. We will need further clarification from the Centers for Medicare and Medicaid Services on this issue in order to guide our standards checklist and survey process. However, we do know that if the final result is a more dynamic relationship between the hospital and the laboratory, and more respect for the role of the pathologist in quality improvement, that would be a good thing.

In coming months, the Laboratory Accreditation Program will announce what changes, if any, are planned to more closely monitor a given laboratory’s control of preanalytic and postanalytic error. But whatever the implementation plan, any changes that occur in the program will be wholly conforming to CLIA and the interpretation rendered by the CMS. The College has long stressed that the pathologist director’s rights and responsibilities don’t end at the laboratory door. This isn’t a new charge; it’s new teeth in an old one.

Rather than wait for word from the Laboratory Accreditation Program, I hope that every laboratory director will make arrangements today to visit department chairs in each service to talk about preanalytic and postanalytic laboratory error. The charge here is to make your people the leavening agents, to encourage them to share their expertise and motivation across the hospital. Get your supervisors and point-of-care experts out to the floors to interact and teach people how to do the job. Let them be like yeast to the dough; they will enjoy it. This will be our mission for 2005, and it could be transformative. Let’s get to it.

Dr. Kass welcomes communication from CAP members. Send your letters to her at