College of American Pathologists
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  President’s Desk Column


cap today

Making it easier to speak up in the lab

July 2004
Mary E. Kass, MD

Pathologists responsible for laboratory administration strive to protect and promote quality. Working with medical and administrative staff, they speak the administrator’s language to communicate the needs of the laboratory. Pathologists are entrusted with significant authority, and there can never be any compromise when it comes to quality. They must use their authority not only to communicate with hospital administrators but also to promote open lines of communication with laboratory staff. Laboratory workers are integral to quality outcomes, and pathologists should always be willing and able to hear their concerns.

The Maryland General Hospital incident demonstrates what can happen when authority figures and pathologists fail to understand that communication with laboratory workers, and timely response to their concerns, not only fosters a productive work atmosphere but also can be critical to quality laboratory medicine. According to press reports, laboratory workers had complained for two years about problems in the laboratory at MGH in Baltimore. They had appealed repeatedly to laboratory and hospital administrators and to state regulatory authorities. However, they never contacted the College. We received just this past May a copy of the 2002 complaint that would certainly have prompted a focused inspection had we received a copy earlier. Such an inspection might have led to suspension of the laboratory’s accreditation much sooner.

The CAP Laboratory Accreditation Program and the state of Maryland cited the laboratory for a specific quality assurance deficiency in 2002 and 2003. In early 2004, however, inspectors from the state, acting in response to a complaint from a lab employee in December, found that quality control issues specific to HIV and hepatitis testing had been concealed when previous inspections took place.

Media reports in March 2004 alerted us to the December complaint and prompted a focused reinspection by the CAP. Subsequently, the College suspended accreditation of the laboratory at MGH for chemistry and point-of-care testing. The laboratory’s medical and administrative directors resigned, along with the hospital president/CEO. The hospital hired a consulting team to clean up the mess. It has located and contacted some 2,000 patients whose 2002-2003 hepatitis and HIV screening test results may have been unreliable. At a May 18 congressional hearing, the hospital reported that 1,000 patients had been retested and the original test results were confirmed in 99.6 percent of the HIV tests.

We strive to make our accreditation system the best there is, and we work hard every day to make it better. But intentional manipulation of data is almost impossible to detect without inside information. In this case, a bad situation went undetected because the College’s accreditation process assumes a reasonable level of integrity in the laboratories we inspect. Where integrity is lacking, the role of whistleblowers becomes paramount.

The College is developing new tools that will make it easier for laboratory professionals to speak up. We are lobbying legislators to extend whistleblower protections in pending patient safety legislation to cover reports to private accrediting organizations like the CAP. Also under consideration: a toll-free telephone number and a Web-based system for complaint reporting, signage to post in laboratories before and after each inspection to publicize College-sponsored complaint reporting systems, and creation of formal opportunities during site visits for laboratory personnel to meet and talk with CAP inspectors.

Fortunately, the College does not stop at routine biennial inspections in its mission to ensure laboratory quality. We receive and act on complaints (87 in 2003 alone) from a variety of sources, including laboratory personnel, and we respond promptly and decisively when problems are uncovered. Many state regulators refer complaints directly to us because they understand that practicing laboratory professionals who are intimately familiar with the nuances of laboratory practice are far better equipped to investigate than someone simply trained to do inspections. The active role of practicing pathologists who know the terrain is one of the great strengths of the CAP’s Laboratory Accreditation Program.

Complaints come in not only to state agencies and the CAP, but also to federal authorities and the Joint Commission on Accreditation of Healthcare Organizations. We need to work with these entities to develop clear protocols that accelerate complaint-related communication. We’re all seeking the same goal; we need to be on the same page. Our job is to anticipate and thwart chicanery by putting the patient first in everyone’s mind. Bad laboratories can hurt patients, and conscientious professionals don’t permit that.

Finally, we need to continually remind ourselves that leadership in pathology includes staff empowerment. Every person in the laboratory is responsible for quality, and each one should feel comfortable about bringing problems to light. It is our job to create a culture within the laboratory in which concerns are discussed freely, addressed quickly, and resolved fairly. Even when this is routine, it can’t be overdone. Bore them to tears with it! Your people won’t work for you forever. People move on. What you teach today may be the ethical echo they need to hear tomorrow.