Medicolegal affairs. International Academy of Cytology Task Force summary. Diagnostic Cytology Towards the 21st Century: An International Expert Conference and Tutorial.

ISSUES: Increasing litigation over alleged false negative cervical cytologic (CC) smears threatens the viability of this test for cervical cancer detection. The problem appears to be largely American but is beginning to appear in some other countries. In the vast majority of cases there is either a settlement or jury verdict for the plaintiff based largely on the testimony of expert witnesses. Cases are judged on an individual basis without significant consideration of the general performance of the CC smear in laboratories operating in compliance with a wide array of laboratory regulations and with documented and comprehensive quality control practices in place. It is acknowledged that there are problem laboratories and cytology practitioners. There is an emerging issue of automated preparation and screening devices and issues of informed patient consent. CONSENSUS POSITION: Cytology professionals have done an extraordinary and commendable job of educating the public about the benefits of the CC smear. We have been less successful and conscientious about explaining and defining the limitations of the CC test. There is a need for public and professional education as to the benefits and limitations of the CC smear for cervical cancer detection. The process suggested is to work with women's groups, public health agencies, government agencies, and state and national legislatures and to coordinate professional committees working on liability issues. Contextual information could be included with the CC smear report to indicate that a negative report confers a low probability of developing cervical cancer. It is suggested that appropriate language and a menu of statements be developed. Increased efforts should be directed to physician education with respect to informed consent concerning the benefits and limitations of CC smear testing and the application of new technology to improve smear accuracy. The process should include development of appropriate statements on the use of alternative technology. The profession should develop "process guidelines" for review of CC smears in the context of possible litigation, including standardized methods for blind slide review of smears that reduce or eliminate context and outcome bias. It is suggested that review panels be anonymous, that the process be standardized and that there be limitations on liability for participating organizations. Professional cytopathology and pathology societies should formulate acceptable guidelines for expert witnesses. The standards should be applicable to both defendant and plaintiff experts. All materials to the extent practical, including consultant opinions, should be available for peer review. Professional cytopathology and pathology societies should monitor expert testimony for objectivity and scientific accuracy. ONGOING ISSUES: For the near future, litigation will continue to focus on false negative CC smears on a case-by-case basis. Laboratories and individuals can reduce the risk of malpractice liability by directing their attention to proactive quality control and quality assurance methods. In the final analysis, consumer education about the benefits and limitations of the test is key to limiting malpractice claims. To stem the tide of continued medicolegal challenges to the integrity of cytology practice, the cytology community has now focused its efforts on developing and utilizing standards that convey to patients, attorneys and cytologists the contemporary status of and reasonable expectations for the practice of cytology. Guidelines such as those for uniform reporting terminology and clinical management of cervical abnormalities form the basis of cytology practice standards on which legal standards of practice can be based. Consensus conference reports, clinical management trials and scientifically valid studies of false negative rates that analyze the type, frequency and cause of missed cases represent sounder methods of establishing defensible

Errors in cervical smears: minimizing the risk of medicolegal consequences.

Cytologists need to critically evaluate their practices and practice settings to ensure that what they do and how they document what they do will withstand both regulatory and legal scrutiny. Any individual involved in cytology as a laboratory owner, operator, director, supervisor, technical or staff employee, independent agent, or customer representative is a potential target of cytology malpractice litigation. All of these individuals must participate in the risk management process. For the laboratory as a corporate entity, business and technical practices, including quality control and quality assurance procedures, must be contemporary, legitimate, and justifiable. Sound scientific evidence and well-subscribed standards of practice supporting an individual's or laboratory's conduct are the best defenses to malpractice claims. For the near future, litigation will continue to focus on false-negative Pap smears on a case-by-case basis. Laboratories and individuals can reduce the risk of malpractice liability by directing their attention to proactive quality control and quality assurance methods. But in the final analysis, consumer education about the benefits and limitations of the Pap test is key to limiting malpractice claims.

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.

Using a CompuCyte Pathfinder to evaluate cytotechnology student diagnostic performance.

OBJECTIVE: To determine whether the Pathfinder Cytology System facilitates comparison of initial student diagnoses to rescreener diagnoses; provides a platform for collection, storage and retrieval of data on student screening performance; and generates a student screening "score." STUDY DESIGN: Using two CompuCyte Pathfinder units networked to a PC server and printer, eight cytotechnology students prescreened 1,224 gynecologic cases and entered their results into the Pathfinder database. Five staff cytotechnologists rescreened the cases and entered their diagnoses. The database containing the initial and rescreen diagnoses were transferred to a modified scoring grid that computed a screening "score" for each of the students. RESULTS: Student diagnoses matched cytotechnologist target diagnoses in 1,107 to 1,224 total cases (90.4%). Of these 1,107 cases, 996 (81.3%) were reported as "within normal limits" (negative) by both student and cytotechnologist, and 111 (9.1%) were target diagnosed as abnormal (atypical squamous cells of undetermined significance [ASCUS] or above) by both student and cytotechnologist. Of 117 remaining cases, 112 (9.2%) were considered minor discrepancies (one-step discrepancy--e.g., benign cell change-reactive vs. ASCUS--favor reactive), and 5 (0.4%) were considered significant discrepancies (two or more diagnostic categories of difference between student and cytotechnologist-within normal limits vs. low grade squamous intraepithelial lesion). The modified scoring grid developed by CompuCyte for this study was able to compute a numerical score for each student. CONCLUSION: Our preliminary assessment indicated that Pathfinder will facilitate evaluation of student performance. The system shows potential for eliminating the "paper trail" and manual dotting required for traditional student evaluation and, with the addition of a scoring program, may be standardized for use in both educational and clinical settings.

In vivo chemosensitivity testing in patients with gynecologic malignancies and nude mouse xenografts by monitoring cell kinetic parameters and DNA distribution patterns: a preliminary report.

Using flow cytometry (FCM) and autoradiography we have evaluated changes in DNA-ploidy patterns as well as cell-cycle perturbations after chemotherapy in 12 patients with accessible tumors and 22 nude mice xenografts. Gynecologic malignancies growing as nude mouse xenografts serve as an experimental model to study the effect of chemotherapy at the cellular level. Excellent correlation was found between fine needle aspiration (FNA) and biopsy material for either FCM or autoradiography. It now appears possible to study the effects of chemotherapy in the patient as well as the animal model using serial FNAs as a microsampling technique.

The adequate Papanicolaou smear revisited.

The reliance on the Papanicolaou smear as a screening and diagnostic test for uterine cancer and its precursors infers that appraisal of the specimen's adequacy is based upon a uniform standard of quality. The presence or absence of endocervical cells in cervical samples has been suggested as one measure of a specimen's adequacy. Not all Cytologists are satisfied with the reliability of this criterion, however. On-going studies are indicated to determine those factors which are critical to the evaluation of the adequacy of these specimens.

Fine-needle aspiration cytology in gynecologic oncology. I. Diagnostic accuracy.

A prospective study was undertaken to determine the diagnostic accuracy of fine-needle aspiration (FNA) cytology in gynecology. A total of 77 aspirations were performed on 74 patients. In 34 instances the purpose was to rule out or confirm a diagnosis of primary disease, and in 43 cases the procedure was used for suspected metastatic disease or disease recurrent after surgery, radiation therapy, and/or chemotherapy. Excellent correlation was noted between the cytologic and subsequent histopathologic diagnoses of 58 aspirations from patients who also underwent surgical biopsy. Two specimens were false negatives as the result of sampling errors. The applicability of FNA cytology in the field of gynecolotic oncology is discussed.

Fine needle aspiration cytology in gynecologic oncology. II. Morphologic aspects.

This study was based on the evaluation of 140 fine-needle spirations from gynecologic lesion. Cytologic criteria for the diagnosis of benign and malignant lesions and cellular changes due to irradiation and chemotherapy are presented. For accurate evaluation of fine-needle aspiration specimens from the pelvis, the exact location of the sampling must be known, clinical data must be available, and the patholgist must have an intimate knowledge of anatomy, histology and pathology of benign and malignant lesions in this area. Fine-needle aspiration cytology provided a high degree of accuracy in the diagnosis of gynecologic lesions.

Fine needle aspiration cytology in gynecologic oncology. I. Clinical aspects.

One hundred forty fine needle aspirations were performed on 124 patients with a variety of gynecologic conditions. The primary goal of this study was to investigate the adequacy of this technique in the primary diagnosis of pelvic masses and in the detection of persistent or recurrent gynecologic malignancies following irradiation or chemotherapy. In this, the first of two articles, the clinical aspects of the procedure, including clinical indications and the different approaches and pelvic sites of fine needle aspiration, are discussed. The simplicity and lack of complications of the method, combined with a high degree of accuracy in predicting the histologic picture of various lesions, merit wider application of this technique as a reliable diagnostic tool in gynecologic oncology.

Endometrial washings histological and cytological assessment of material obtained with an intrauterine jet washing device.

The histological and cytological assessment of material obtained with an intrauterine jet washing device from 138 patients with postmenopausal bleeding, abnormal premenopausal bleeding or infertility is presented. In the first part of the study 55 washings were examined by histological techniques and the findings compared with those in material subsequently obtained by curettage or endometrial biopsy. Only 32 (58 per cent) of the washings were satisfactory for evaluation of the endometrium compared with 46 (84 per cent) of the curettings. When, in the second part of the study the washings in 83 cases were examined by both histological and cytological methods, 76 (92 per cent) were satisfactory compared with 59 (71 per cent) of the curettings. Cytological examination of the washings in the postmenopausal women provided a significantly higher proportion of satisfactory specimens than histological examination alone or evaluation of the curettings. In the whole study, three cases of endometrial carcinoma were diagnosed by endometrial washings and by curettage, while in six cases of endometrial hyperplasia one false negative was obtained by histological examination of the washings and one by examination of the curettings. This study shows that endometrial samples obtained with the intrauterine jet washer provide information about the endometrium which is comparable with that obtained by conventional curettage, and also that in postmenopausal women endometrial lavage may be more reliable than curettage.