During the past 10 years, CYTOPATHNET has included candid discussions on new technologies (e.g. Liquid-based Pap tests, "out-of-vial" molecular testing, HPV testing), revised reporting and classification systems for cervicovaginal cytology (e.g. Bethesda 2001), CLIA '88 (via the CLIA Forum, hosted by Sandra Fite, CT/ASCP), Pap smear litigation, guidelines for slide review in litigation, Pap smear "informed consent", False Negative Fraction/Proportion, cytology Proficiency Testing, and more, based on dialogue with our membership, expert treatises, and constant updating of our information base.
There have been some advances in the tools available to achieve the goals for which cytology was first developed. Some of these advances have greater influence on the primary goal of improved predictive value of our services than others (e.g. HPV testing, imaging versus liquid based methodologies), but all incrementally enhance the quality of our service in identifying pre-neoplastic changes. As a result of several high profile reports (1,2) the U.S. Congress has taken a number of actions, which legislators believe will enhance Patient Safety.(3) This has prompted an increased interest and awareness by the public in quality in medicine. New governmental organizations have been formed to focus on quality in healthcare (e.g. Institute for Quality in Laboratory Medicine (IQLM), Agency for Healthcare Research and Quality (AHRQ)) , and changes in enforcement of existing CLIA regulations and standards have occurred in response to public airing of concerns (e.g. CAP policy to have "unannounced inspections"(4) which followed the Congressional hearings of Maryland representative Elijah Cummings)(5). The Cytology Proficiency Testing (PT) mandate, which was formulated in 1988 as part of the CLIA '88 regulations and signed into law in 1992, finally saw its controversial implementation over 16 years later, in 2005.(6)
Despite increased governmental and professional awareness and action on quality in healthcare, public confidence in pathology, including Pap testing (damaged by what was shown in the 1987 Pulitzer Prize-winning Wall Street Journal article by Walt Bogdanich exposing "pap-mills" (7), a report which ultimately resulted in CLIA '88), remains shaken by those reports and the continued actions and inactions of some laboratories in the two decades which followed. The pathology and cytology community are struggling to regain the confidence that some events have caused. Recent professional publications and media attention on pathology errors continue to "stir-the-pot". (1,2,8) Medical professionals find themselves in a Catch-22. In order to implement quality improvement and change, one needs to critically evaluate practice and performance, and publish in a peer-reviewed environment. However, because of the legal implications, and risk for litigation, authors are at much risk of criticism and personal hardship when they do so. And, when they do publish this information with the intent for all to learn on how to improve the quality of care we provide, this information may be misrepresented (in good faith) by the lay-press in order to elicit a public response of concern in order to effect change, in a manner modeled after the success of the Wall Street Journal article in affecting CLIA '88.
We need to take the lead in working to effect improvement in public (consumer) confidence in the quality of pathology and cytopathology performed in the US as well as worldwide. It is not likely that we need new and/or additional legislation geared toward the protection of Quality Improvement data and the individuals/institutions collecting and reporting that information; but what we need is to understand and implement the existing standards (CLIA) and continue to evaluate candidly our strengths and weaknesses. One of the first steps is to develop and implement a universal standard of Quality Improvement and data reporting. The challenge begins at the individual level, starting from the consumer's essential role in their care, by assuring that they have regular checkups, cancer screening and necessary follow-up. This is their personal responsibility. Once they are in our care, each of us has an inherent obligation at each step of the process to assure the highest quality care, from assuring that a patient's name is spelled correctly, their identifiers are correct, their history is correct, the quality assurance of cytologic-histologic correlations (9) and 5-year look-backs are timely done and recorded so that accurate, complete, and timely delivery of the pathology report to the correct medical practitioner caring for the patient is achieved. The adoption of this concept is a systems issue (10) that, as with all systems issues, begins with the individual, whether at the technical level, the managerial level, the director level, the billing level or the hospital/medical center administration level. In fact we are all students, hopefully recognizing the learning value of each error in a manner that will continue to evolve the critical service we provide to patients and physicians who rely on our services. CYTOPATHNET has been here to air your concerns, and to help us all learn from them, and in doing so, provide an international forum to continuously improve our professional contributions to health care.
Jana C. Sullinger, MD
1. Raab SS. Improving patient safety by examining pathology errors. Clin Lab Med. 2004 Dec;24(4):849-63.
2. Raab SS, Grzybicki DM, Janosky JE, Zarbo RJ, Meier FA, Jensen C, Geyer SJ. Clinical impact and frequency of anatomic pathology errors in cancer diagnoses. Cancer. 2005 Nov 15;104(10):2205-13.
5. Walter F. Roche Jr. Hearing to probe hospital errors. baltimoresun.com. Originally published May 17, 2004.
8. Ed Uthman, MD. Stay tuned for CLIA '06!. PATHO-L (US-specific). Sat Dec 3 10:46:27 MST 2005.
9. Colleen M. Vrbin, BS; Dana M. Grzybicki, MD, PhD; M. Sue Zaleski, CT(ASCP); Stephen S. Raab, MD. Variability in Cytologic-Histologic? Correlation Practices and Implications for Patient Safety. Archives of Pathology and Laboratory Medicine: Vol. 129, No. 7, pp. 893–898. Download PDF version.
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