Educational Objectives:
1. Compare the participants’ experience in providing coverage for onsite evaluation of adequacy among different institutions
2. Evaluate various methods of cytologic preparations to maximize laboratory efficiency and diagnostic yield
3. Appropriately use CPT codes 88172 & 88177

FNA of superficial and deep seated lesions are performed increasingly by radiologists, gastroenterologists and pulmonologists. Providing onsite evaluation of adequacy by cytopathology personnel is advocated as a measure to decrease the nondiagnostic rate. The session will include a presentation that summarizes the diagnostic rates of FNA in two different settings: one with and another without the benefit of onsite assessment of adequacy. The presentation will focus on the results of pancreatic and thyroid FNA, as they represent the two most commonly aspirated sites at Georgetown Hospital. The value of onsite preparation of direct smears versus rinsing most or the entire sample in the appropriate media for liquid-based and cell block preparations will be discussed. The session will conclude with an open discussion among the participants to compare different practices of providing coverage among various institutions.

Educational Objectives:
1. Understand the phases of and the special requirements for the clinical laboratory participation in the conduct of clinical trials – why CLIA certification is not sufficient to meet FDA requirements
2. Review requirements to perform laboratory testing for clinical trials, either as a clinical trial site or as a central laboratory
3. Review the chronology, results and/or goals of key clinical trials focused on screening for or primary prevention of cervical cancer over the previous decade and a half, including liquid-based cytology, computer assisted screening, ALTS, HPV testing, HPV vaccines and molecular Paps

Dr. George Nicholas Papanicolaou’s cytological method, the so-called Pap smear, was the first screening test that successfully led to a reduction in the targeted cancer death rate. In fact, its application in the United States alone is credited with a reduction in death from a baseline in 1940 by 70-90%. However, that test was never approved through a formal clinical trial, which today is the requirement for use of a new test in human populations. It took decades before technological innovations challenged the traditional Pap smear. Beginning in the 1990’s, several trials were initiated ranging from creation of a liquid-based cytology sample to use of computer assisted screening. What are the requirements for the conduct of clinical trials? Are there differences between drug/vaccine trial requirements and in vitro diagnostics trails? How does an anatomical pathology laboratory support appropriate trials? What have the clinical trials focused on reduction of death from cervical cancer contributed over the last fifteen years, especially in the context of Dr. Papanicolaou’s original Pap smear? This session will try to provide answers to those questions and point to new trials on the horizon in the continuing saga to try and eliminate morbidity and mortality from cervical cancer.