COMPUTERIZED SCREENING DEVICES AND PERFORMANCE ASSESSMENT - DEVELOPMENT OF A POLICY TOWARDS AUTOMATION - IAC TASK-FORCE SUMMARY

The extension of automation to the diagnostic assessment of clinical m aterials raises issues of professional responsibility, on the part of both the medical professional and designer of the device. The Internat ional Academy of Cytology (IAC) and other professional cytology societ ies should develop a policy towards automation in the diagnostic asses sment of clinical cytologic materials. The following summarizes the di scussion of the initial position statement at the International Expert Conference on Diagnostic Cytology Towards the 21st Century, Hawaii, J une 1997. 1. The professional in charge of a clinical cytopathology la boratory continues to bear the ultimate medical responsibility for dia gnostic decisions made at the facility, whether automated devices are involved or not. 2. The introduction of automated procedures into clin ical cytology should under no circumstances lead to It lowering of sta ndards of performance. A prime objective of any guidelines should be t o ensure that an automated procedure, in principle, does not expose an y patient to new risks, nor should it increase already-existing inhere nt risks. 3. Automated devices should provide capabilities for the med ical professional to conduct periodic tests of the appropriate perform ance of the device. 4. Supervisory personnel should continue visual qu ality control screening of a certain percentage of slides dismissed at primary screening as within normal limits (WNL), even when automated procedures are employed in the laboratory. 5. Specifications for the d esign of primary screening devices for the detection of cervical cance r issued by the IAC in 1984 were reaffirmed. 6. The setting of numeric performance criteria is the proper charge of regulatory agencies, whi ch also have the power of enforcement. 7. Human expert verification of results represents the ''gold standard'' at this time. Performance ch aracteristics of computerized cytology devices should be determined by adherence to defined and well-considered protocols. Manufacturers sho uld not claim a new standard of care; this is the responsibility of th e medical community and professional groups. 8. Cytology professionals should support the development of procedures that bring about an impr ovement in diagnostic decision making. Advances in technology should b e adopted if they can help solve problems in clinical cytology. The in troduction of automated procedures into diagnostic decision making sho uld take place strictly under the supervision and with the active part icipation and critical evaluation by the professional cytology communi ty. Ongoing Issues Guidelines should be developed for the communicatio n of technical information about the performance of automated screenin g devices by the IAC to governmental agencies and national societies. Also, guidelines are necessary for the official communication of IAC c oncerns to industry, medicolegal entities and the media. Procedures an d guidelines for the evaluation of studies pertaining to the performan ce of automated devices, performance metrics and definitions for evalu ation criteria should be established.