Impact of automated technology on the cervical cytologic smear. A comparison of cost.

The cervical cytologic screening test for cervical cancer is the largest-volume cancer screening test currently conducted predominantly without the advantage of process automation. Much attention has been directed toward commercial application of automated technology to support both quality enhancement and productivity gain in cervical cytology screening. Several systems are now available for clinical application that address various aspects of cervical cytologic screening automation. These include specimen-preparation devices and image-based automated screeners. Each system provides a different mix of benefits and impacts cost differently as well. This, coupled with the fact that few systems are in broad clinical use as yet, makes it difficult to conduct parallel cost-benefit analysis. A comparison is presented on the impact of system use on the laboratory's cost to conduct the test. Although there is a demand for technology that can support improvements in quality and/or productivity of cervical cytologic screening, there is also a responsibility for fiscal prudence in technology implementation. Products that dramatically increase the cost of service, and thus perhaps limit access to care for some patients, may have an impact on patient outcomes quite apart from that intended.

Quality assurance/control issues. International Academy of Cytology Task Force summary. Diagnostic Cytology Towards the 21st Century: An International Expert Conference and Tutorial.

ISSUES: General definitions of quality assurance and quality control (QA/C) have existed in many forms for decades, and a new discipline guides their application to diverse industrial and recently medical processes without much fanfare. However, in the field of cervical cytology screening, the range of QA/C options has recently broadened and become controversial. With the advent of new systems of terminology, larger-scale laboratories and new technologies--plus strong governmental and legal pressures in some nations--the range of extremely difficult and sometimes expensive QA/C choices our community faces is greater than ever. CONSENSUS POSITION: At our conference, the basic definitions of QA/C posed little difficulty. Presentation of the range of methods in use today and of those based on new technologies where use is proposed or has just begun also was achieved with little or no dispute. However, there was lack of consensus on exactly how QA/C methods are to be assessed. Indeed, there was little consistency in the use of different outcome measures with which we can judge success or failure of specific QA/C options. In addition, the tension between pressure to adopt sometimes uncertain or expensive method enhancements and pressure to maintain affordability and the widest possible access for populations that most need cervical cytology screening is greater than ever. ONGOING ISSUES: More data are required that would enable assessment of QA/C options with the clearest possible understanding of cost/benefits and current or new assumptions of risk. Other task forces, such as medicolegal, cost/benefit and those devoted to new technologies, are our essential partners in meeting the challenges described above.

Computerized training and proficiency testing. International Academy of Cytology Task Force summary. Diagnostic Cytology Towards the 21st Century: An International Expert Conference and Tutorial.

ISSUES: Computerized technologies probably will revolutionize the field of gynecologic cytology in the next century. Such technologies will be useful in both training and evaluating proficiency. However, manual screening/review of gynecologic cytology preparations is the current "gold standard" for both training and assessment of proficiency. CONSENSUS POSITION: Training programs for cytotechnologists and pathologists should provide instruction and experience in new technologies, but their introduction may depend on the availability of equipment and staff. Advantages of digital images for training include standardization of teaching sets and interactive capabilities, allowing educational feedback. Computerized support/assistance devices aid in complete screening of the slide during training and provide feedback to cytologists on screening techniques. Liquid-based cytopreparatory instruments facilitate multiple glass slides for teaching or testing. Proficiency testing (PT) in cytology has similar quality assurance goals as in other areas of the laboratory, but the subjective nature of cytologic analysis poses many challenges for implementation. There is consensus that all cytology practitioners would like to know the proficiency of the laboratory. However, the majority question the value and validity of any large-scale formal testing programs. Locator and diagnostic skills are both critical in cytology, but assessment of each skill may occur in different ways using computerized technologies. Any type of assessment should provide educational feedback to participants. Psychometric issues in PT include the consideration of different types of validity, including face, content, construct and criterion related. The reliability or consistency of the testing event is also critical. A valid and reliable correlation between work performance and performance on a PT needs to be established. The goal is to ensure that PT will identify submarginal practitioners and that persons successful on PT are in fact competent. Any cytology PT program should also be considered in the context of other laboratory quality assurance tools and the entire cervical cancer screening program. Regulatory agencies should evaluate entire laboratory performance, while each laboratory director should assume primary responsibility for evaluating and documenting the competency and daily performance of each practicing cytologist. Professional scientific organizations should take the lead in recommending methods and standards of performance assessment. ONGOING ISSUES: A reliable method of correlating daily competency with results on PT is not yet established. Methods may evolve ever time using new technologies. The use of computerized techniques and images for assessment will require careful deliberation by experts as well as validation by practicing cytologists. Variables include diagnostic categories for testing, numbers of challenges per testing event, types of slide preparations and characteristics of the digital images. Availability of equipment and staff will affect the introduction of new technologies in different regions.

Utility of the TracCell system in mapping Papanicolaou-stained cytologic material.

BACKGROUND: Much attention has been directed toward commercial application of automation technology to support both quality and productivity enhancement in cervical cytology screening. The introduction of a fully automated precision microscopy workstation, the AcCell Series 2000, (Accu-Med International, Inc., Chicago, Illinois, U.S.A.) has made it possible to effectively incorporate automated prescreening systems that support the human screener. SYSTEM DESIGN: The TracCell 2000 slide mapping system (AccuMed) is a fully automated, stand-alone prescreening device for Papani-colaou-stained cytologic material, such as cervical cytology specimens. The system locates the areas of the slide that do not require review and maps material in the remaining areas; it finds the optimal focal plane, calculates a preferred routing path for human review and determines speed adjustment relative to material density variation. Through slide bar coding identification, this information is transmitted to the AcCell precision microscopy workstation for presentation of the specimen to the human screener. DISCUSSION: By making it possible to automatically guide the human screener to the material of interest, the TracCell system eliminates the need to review empty space and irrelevant areas of the slide. This has the immediate advantage of improved productivity. In addition, by reducing the need to review neutral background material, the system increases the signal-to-noise ratio, thus contributing to a sustained level of vigilance in the screener. The system also addresses operator fatigue through computer-assisted focus and speed variation. This instrument is for investigational use only. The performance characteristics of the device have not been established.

The AcCell series 2000 as a support system for training and evaluation in educational and clinical settings.

Providing effective training, retraining and evaluation programs, including proficiency testing programs, for cytoprofessionals is a challenge shared by many academic and clinical educators internationally. In cytopathology the quality of training has immediately transferable and critically important impacts on satisfactory performance in the clinical setting. Well-designed interactive computer-assisted instruction and testing programs have been shown to enhance initial learning and to reinforce factual and conceptual knowledge. Computer systems designed not only to promote diagnostic accuracy but to integrate and streamline work flow in clinical service settings are candidates for educational adaptation. The AcCell 2000 system, designed as a diagnostic screening support system, offers technology that is adaptable to educational needs during basic and in-service training as well as testing of screening proficiency in both locator and identification skills. We describe the considerations, approaches and applications of the AcCell 2000 system in education programs for both training and evaluation of gynecologic diagnostic screening proficiency.