UPDATING OF DEVICES GUIDELINES

The International Academy of Cytology published guidelines for designers of automated systems (Acta Cytol. 28:p.352, 1984) which are still official IAC policy. It is advisable to update these guidelines at this time, in view of recent developments in hardware and software design.

The 1984 IAC-standards were divided into two major groups: (I) Mandatory Conditions and (II) Highly Desirable Features:

I. Mandatory Conditions (Conditio sine qua non)

1. The system shall not be designed or constructed as to pass as negative any sample that contains malignant tumor cells;
2. The system shall not flag more "false alarms" on normal cells than could be readily handled by visual manual review;
3. The system shall not use up the entire sample or render the sample unusable for classical microscopic review; the pathologist must be able to examine the sample after routine staining;
4. The system shall yield reproducible results on repeated scannings of the same sample (within appropriate confidence limits);
5. The system shall have an internal calibration standard for quality control; and
6. The system shall identify the inadequate (or empty) slide.

II. Highly Desirable Features (Required for clinical application)

1. The system should be able to demonstrate clearly the item that led to an "alarm" for subsequent review by a human observer;
2. The system should include dysplastic cells in the alarm group and should not restrict itself to the identification of frankly malignant tumor cells;
3. The system should detect and identify contamination and artifacts as such to avoid unnecessary human review;
4. The preprocessing of the sample required to a given system should be convenient and inexpensive for the clinician and laboratory (worst case: a system requiring specific preprocessing that is more expensive than the entire routine classical work-up and evaluation while not offering improved diagnostic quality);
5. Infectious organisms, such as trichomonads and fungi, as well as "footprints," as in herpes inclusions and koilocytosis, should be identified; and
6. The system should operate cost effectively.

The IAC created an Ad Hoc Subcommittee on QA-Guidelines for Automated Systems for updating of the above 1984 guidelines. This undertaking reflects the fundamental belief that the IAC and like international organizations have a responsibility to guide the future of our profession on an international basis. Readers are encouraged to submit comments on the 1984 guidelines and on possible reconsideration of updated guidelines. Comments may be submitted to the editorial office of ACTA CYTOLOGICA (FAX: 773-947-0290, or e-mail: info@cytology-tutorial.org)