College of American Pathologists
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  President's Desk




July 2007
A quality checkup for office labs

Thomas M. Sodeman, MD

Quality means doing it right when no one is looking.

—Henry Ford

Most people associate Henry Ford with cars, but he was more notably a pioneer of assembly line production. The man understood the connection between good systems and quality. He would have been very much at home with the Institute of Medicine team that wrote “To Err is Human,” an exhaustive look at the causes and cures of medical error published nearly 100 years after the Model T rolled off the line.

“Good Laboratory Practices for Waived Testing Sites,” a report from a Clinical Laboratory Improvement Advisory Committee workgroup chaired by Jared Schwartz, MD, PhD, refers to the Institute of Medicine report as a seminal document, and indeed it is. “Preventing errors and improving patient safety require a systems approach,” the CLIAC team writes, a position that has steadily gained traction since the IOM report came out.

The Clinical Laboratory Improvement Amendments of 1988 authorize the Centers for Medicare and Medicaid Services to oversee the conduct of simple point-of-care tests using devices that are waived from most federal oversight requirements. The CMS issues certificates of waiver (CW) to sites where these tests may be conducted. Waived testing is growing exponentially, applying to 1,600 test systems representing at least 76 analytes as of 2004. At that time, CW sites conducted less than 10 percent of total testing in the United States but made up 58 percent of the 180,000 testing sites in the United States.

First published in the Nov. 11, 2005 Morbidity and Mortality Weekly Report and now linked to the College’s PT Check Up site, “Good Laboratory Practices” is an excellent resource for anyone with responsibility for waived testing. The report describes quality issues identified in on-site surveys and studies of waived testing practices conducted by the CMS and the Centers for Disease Control and Prevention between 1999 and 2004.

The CMS and the CDC surveys determined that the majority of CW sites performed testing correctly, provided reliable service, and followed manufacturer instructions for test performance. Many also followed additional good laboratory practices. Yet a persistent percentage of CW sites did not meet minimal requirements and were not aware of the recommended quality assurance measures. Most directors and testing personnel in CW laboratories did not have formal laboratory training or testing experience. Personnel turnover was high and training procedures were variable.

The only CLIA requirement for performing waived testing is to follow manufacturer instructions, but not all CW sites had current instructions (12 percent did not) and there were compliance concerns among those that did, meaning that manufacturer instructions regarding quality control, reporting results, checking expiration dates on analytes, storing materials appropriately, and calibrating systems were not always followed. In short, there were concerns about practices that could lead to errors and poor patient outcomes. The CLIAC report made recommendations to help the staff of waived testing laboratories avoid testing errors that might lead to preventable morbidity and mortality.

Within the College, the CLIAC report raised concerns about patient safety. Reliable results from waived tests, just like reliable results from nonwaived tests, call for systematic attention to personnel training and continuing education along with carefully structured quality assurance.

The need for educational tools to assist those responsible for waived testing was evident and the College responded with a unique program, developed under the oversight of the CAP Point of Care Testing Committee and based on the recommendations in the CLIAC report.

On July 30, the College will mail the first annual challenges to subscribers of Patient Test Check Up (PT Check Up), a unique and affordable educational program to help physician office laboratories that perform only waived tests provide reliable results. Subscribers receive user-friendly tools to help train laboratory staff, evaluate instrument and method performance, troubleshoot, and assess the competence of those conducting the testing. The single annual mailing will include two unknown test specimens for each module ordered by the subscriber, instructions, an answer sheet, answers, and a one-page educational discussion on good laboratory practices. Subscribers also have access to a broad menu of continually updated resources and educational materials on the PT Check Up Web site. Based on the type and number of tests performed, the cost could be as little as $55 per year. There is some urgency, because though all modules are available to those who subscribe by July 30, some analytes will not remain stable for shipping after that date.

The law requires that waived tests have “insignificant” risk for error, but there is no such thing as an error-proof test. Errors in “simple” tests used to adjust medication dosages in patients undergoing anticoagulation therapy can significantly affect patient well-being. And mistakes in reporting results from waived diagnostic tests, such as that for HIV, may have unintended consequences. While the public health impact of 40,000 new HIV infections each year drove the decision to waive the HIV test, its waiver consists of unique requirements for sale and use. Those who conduct HIV testing must provide robust quality assurance programming, something that PT Check Up will help to support.

As leaders in laboratory medicine, it is our place to promote quality in every testing venue, and safety requires a systems approach. If you have responsibility for a laboratory that does only waived testing, or if you know someone who does, please investigate and promote PT Check Up. Though waived testing sites may have fewer oversight requirements, a waiver does not mean no one is looking out for the patients involved. Somebody is looking. We’re right here.

Dr. Sodeman welcomes communication from CAP members. Send your letters to him at