College of American Pathologists
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  All Eyes on Cytopathology
  Lab Inspections


October 2004
Originally published in CAP TODAY

Anne Ford

As automation's grip on the cytopathology laboratory tightens, lab directors may wonder how to make the best use of new technology and still adhere to CAP inspection requirements. That's one of the issues that prompted "Inspecting the Cytopathology Laboratory," a Laboratory Accreditation Program audioconference presented by Francis E. Sharkey, MD, regional commissioner for the program's Mid-South Region, on July 14. "A key take-home message from this discussion has to do with change," Dr. Sharkey told participants. "Staying current with these new technologies is becoming critical to a properly functioning laboratory."

Dr. Sharkey summed up what makes the cytopathology inspection unique: the regulatory environment brought on by CLIA '88, the public's and media's interest in the accuracy of Pap test interpretations, and the significance of the on-site microscopic review. Each of these puts pressure on the inspector to be fair and comprehensive.

Focusing on the latest checklist revisions, Dr. Sharkey noted that the term "quality improvement" has been replaced by "quality management." The new terminology comes from ISO 15189, the proposed new international standard for medical laboratories, and will eventually appear in all CAP checklists. More important, sections have been added for checklist questions that are specific for gynecologic and nongynecologic specimens. "Previously, questions related to both tended to be lumped together," he said, "this often led to confusion as to which discipline each checklist item referred to."

Moving to quality control issues, Dr. Sharkey pointed out that the requisition form must now include the patient's gender, and the final report must now include several items previously considered merely desirable, such as the name and address of the laboratory, the anatomic source or type of specimen, and the test performed. Quality control of instrument function and maintenance records has been clarified with a new note. "First of all, maintenance records should show evidence of ongoing evaluation," Dr. Sharkey said. "So the inspector should look for the reviewer's initials and the review date on daily logs, and this review should be performed at least monthly." The note also emphasizes the importance of complying with the manufacturer's recommendations for monitoring instruments. If a lab chooses not to do so, it must prove that its own protocol is "as good or better." Finally, the lab must demonstrate that it routinely evaluates the acceptability of slides prepared by automated instruments each day the instruments are in use.

The checklist requirement for a twice-yearly evaluation of the lab's maximum screening workload has also been clarified. The definition of screening must include not only newly screened slides, but also slides examined during the "10 percent re-screen" and the "five-year lookback" procedures. When lab directors assign the maximum screening workload for each staff member who screens slides, they must "take into account performance on both 10 percent rescreens and information on the comparison with the pathologist's final interpretation," Dr. Sharkey said. Finally, in reporting daily workload, slides prepared from liquid-based preparations must be counted as one slide for gynecologic cases, but they may be counted as one-half slide for nongynecologic specimens.

Although the requirement for formaldehyde and xylene vapor testing changed several years ago, Dr. Sharkey chose to review it because, he said, "I still see confusion on this point when I inspect laboratories." The key change is that laboratories are no longer required to conduct vapor testing every year. "Test the first time," Dr. Sharkey said. "If it's okay, you don't have to retest until something changes." That is, labs must perform initial vapor testing, retesting only if they exceed the vapor action level, or if they significantly change the way they handle those vapors, or if a staff member suffers an exposure-related condition, such as a skin rash or breathing difficulty. Adding staff to an area also warrants reassessment because the possibility of overexposure is greater.

The Occupational Safety and Health Administration mandates eight-hour time-weighted and 15-minute short-term exposure level determinations. Why two different tests? "Exposure to these vapors tends to be intermittent during the day, and one would want to be sure that inappropriately high short-term exposures are not being averaged out if only an eight-hour measurement is done," Dr. Sharkey explained.

Shifting his attention to the most recent checklist revisions, which went into effect in June, Dr. Sharkey addressed the new requirements for implementing automated instruments. The laboratory must document how it implements an instrument and how it trains its staff to use it. The lab must follow the manufacturer's instructions. "If there are no such instructions," he said, "the laboratory should have its own documented procedures." In addition, the lab must define and monitor tolerance limits for diagnostic accuracy and specimen adequacy, define and follow a procedure for handling slides the instrument doesn't process successfully, and develop a process for handling workload when the instrument is down.

The latest checklist revisions also include a new phase II question: "Does the cytopathology report clearly indicate the name of the pathologist who has reviewed the slides, when applicable?" "The 'when applicable' part," Dr. Sharkey said, "means that this applies only to cases in which the pathologist has actually reviewed the slides and made an interpretation." The question is designed to avoid the possibility of a pathologist appearing to take credit for a report for which the pathologist has not reviewed the slides. While the name of the laboratory director may appear in the report, it must appear in a distinctly marked place where it can't be mistaken for the reviewing pathologist's name. The report need not include the name of the reviewing cytotechnologist, but the lab must keep a record of which cytotechnologist reviewed the slides for each case.

Laboratories will find a new note in the checklist regarding slide storage. "Specifically, slides must be stored in a controlled environment that will protect the technical integrity of the slides," Dr. Sharkey said. High temperature may lead to premature fading of the stain, and high humidity can promote mold growth on slide labels, making them unreadable. The slides must be organized to permit ready retrieval.

The new edition of the checklist also contains a table of frequency statistics for such diagnostic categories as ASCUS, LSIL, ASC/SIL, and unsatisfactory rates in U.S. laboratories. The table has been updated with new data from 2003. In addition, Dr. Sharkey pointed out, "a separate table has been added for liquid-based preparations since these figures are slightly different." These benchmark data, he continued, are to be used with question CYP.07650, which asks: "If the laboratory's annual ASC/SIL ratio for gynecologic cases falls outside the 5th or 95th percentile, has the laboratory determined and documented the reason?"

Another checklist innovation is a new turnaround-time exception for screening specimens, such as urines, in addition to the already established exception for special processing or special staining techniques. While the standard requirement is that 90 percent of non gyn e co logic cases must be reported in two working days, a lab can make an exception for certain specimens, as long as it defines the types of specimens to be included in this exception and defines and documents target turnaround times for them.

Finally, Dr. Sharkey reviewed issues surrounding the determination of workload with automated screening instruments. "For instruments that employ an interaction between cytotechnologists and the automated screening instrument," he said, "the slide may count for less than one slide in terms of screening workload." But, he cautioned, the lab isn't allowed to come up with its own workload accounting—it must adhere to manufacturer instructions.

The full audioconference, including the question-and-answer session on histology-cytology correlations, the definition of highly cellular specimens, HIPAA, and more, can be accessed on the CAP's Web site.

Anne Ford is a writer in Chicago.