Back to basics: validation of automated as compared to manual slide staining in the cytopathology laboratory.

Regulatory agencies on laboratory accreditation require that a laboratory validate and document an instrument's functionality in its own specific environment, including the capability of the instrument to replace existing processes. Instruments without manufacturer-provided validation protocols must still undergo validation with documentation of the specific method used. This study was performed to validate the Sakura Tissue-Tek DRS 2,000 automated slide stainer.

Validation in the cytopathology laboratory: its time has come.

The cytology laboratory has traditionally performed a relatively small variety of tests. The testing processes employed were generally manually performed and included preparation of glass slide materials, staining of these slides, coverslipping, and microscopic evaluation of the cellular material. Instrumentation in the cytology laboratory was very limited and included a centrifuge, membrane filtration system, and possibly an automated staining machine. If instruments were added, for example, a liquid based preparation device or an automated coverslipping device; the instruments were rarely checked to assure they were operating properly before implementation into clinical practice. In addition, little documentation was maintained with regards to the instrument performance evaluation process. Increasing automation and expansion of testing options have changed how cytopathology is practiced. There are many new devices employed for the preparation of specimens, staining and coverslipping of slides, and evaluation of cellular material. The increasing use of molecular testing methods in cytopathology further adds to the changing landscape of cytopathology. New instrumentation and testing methods are routinely being introduced and the cytopathology laboratory must assure that the testing performed is accurate and consistent. Cytopathology laboratory professionals need to appreciate the value of validation of the tests we perform and the instruments we use in order to best serve the patient. Our clinical laboratory colleagues have traditionally performed validation on both instruments and test methods before using them for clinical testing. If cytopathology wants to perform the complex testing being introduced and effectively utilize new instrumentation, we need to understand the value of validation and how we apply validation to our laboratory practice.

Protocol for the processing of bloody cervical specimens: glacial acetic acid and the ThinPrep Pap Test.

Since the utilization of the ThinPrep Pap Test in clinical practice, laboratories have strived to optimize cellular yields from cervicovaginal samples. Bloody specimens that often hamper cytologic interpretation and/or render a specimen unsatisfactory for diagnosis on conventional smears also affect ThinPrep preparations. Currently, there is no uniformly utilized method for the processing of bloody cervical specimens sent for analysis by the ThinPrep method. The purpose of this study is to present the protocol utilized by the University of Wisconsin Hospital and Clinics.

The other side of the needle: a patient's perspective.

Cytopathology laboratories monitor the analytical processes that have an impact on patient care through sound, quality assurance programs. What often frustrates pathologists is their relative inability to influence pre-analytical variables, those processes that are health-care-provider driven. The performance of fine-needle aspirates (FNAs) is a unique opportunity for the pathologist to become directly involved in the pre-analytical phase of patient care. We formulated a patient satisfaction survey, to assess the care provided by the FNA team, as it is related to patient safety, satisfaction and complications related to the FNA procedure. The application of patient surveys is a valuable tool to identify, track and monitor complications related to the performance of FNAs and as an ongoing monitor of direct involvement of the pathologist in the pre-analytical process.