Quality assurance activities of the College of American Pathologists

Since its inception, the College of American Pathologists (CAP) has played a fundamental and pivotal role in the development and execution of quality assurance programs for laboratories. Within the realm of anatomic pathology, operational programs include those in surgical pathology, immunohistochemistry and cytopathology. The emphasis of prior cytopathology programs on cervical cytology has now been expanded to include body fluids and fine needle aspiration material. CAP's role in the expansion of quality assurance programs in cytology may be enhanced in the future by intersociety cooperation with established cytology organizations and will also be influenced by and closely linked to the expansion of its quality assurance programs in surgical pathology. As for the Papanicolaou smear, it can no longer be regarded as the "Cinderella of cytology"; it is in fact the present-day cynosure in the laboratory. In recognition of this, CAP has undertaken efforts to help heighten public awareness about the value of Papanicolaou smear testing and is encouraging women to become more informed about the process involved in the examination of their smears.     

Education and training for cytopathologists. Its role in quality assurance

The role of education and training for cytopathologists in assuring quality in cytology laboratories is discussed, with particular attention given to (1) the problems in the diagnosis of Papanicolaou smears and (2) the contributions of the American Society of Cytology to cytology education. While many people contribute to the success or failure of gynecologic screening programs, poorly trained pathologists can be an especially weak link in the chain given their position in the diagnostic process. Well-formulated residency programs and the use of other educational resources can produce higher-caliber cytopathologists. The problems in Papanicolaou smear screening need to be defined, discussed and resolved by well-trained cytopathologists in conjunction with the clinicians and cytotechnologists involved.     

A survey of medical quality assurance programs in Ontario hospitals.

OBJECTIVE: To determine the prevalence and types of medical quality assurance practices in Ontario hospitals. DESIGN: Survey. SETTING: All teaching, community, chronic care, rehabilitation and psychiatric hospitals that were members of the Ontario Hospital Association as of May 1990. PARTICIPANTS: The person deemed by the chief executive officer of each hospital to be most responsible for medical administration. INTERVENTION: A questionnaire to obtain information on each hospital''s use of criteria audit, indicators inventory, occurrence screening and reporting, and utilization review and management (URM) activities. OUTCOME MEASURES: Prevalence of the use of the quality assurance activities, the people responsible for the activities and the relative success of the URM program in modifying physicians'' performance. RESULTS: Of the 245 member hospitals participants from 179 (73%) responded. Criteria audits were performed in 136 (76%), indicators inventory in 43 (24%), occurrence screening in 44 (25%), occurrence reporting in 61 (34%) and URM in 123 (69%). In-hospital deaths were reviewed in 157 (88%) of the hospitals. In all, 87 (55%) of the respondents from hospitals that had a URM program or were developing one indicated that their program was successful in modifying physicians'' practices, and 29 (18%) reported that it was not successful; 26 (16%) stated that the effect was still unknown, and 16 (10%) did not respond. Seventy (40%) stated that results of tissue reviews were reported at least 10 times per year and 94 (83%) that medical record reviews were reported at least as often. The differences in the prevalence of the quality assurance activities between the hospitals were not found to be significant. CONCLUSIONS: Many Ontario hospitals are conducting a wide variety of quality assurance activities. Further study is required to determine whether the differences in prevalence of these activities between hospitals would be significant in a larger, perhaps national, sample. Strategies are needed to ensure universal involvement and participation in the improvement of the quality of care and the assessment of the cost-effectiveness of health care treatments. Recommendations to achieve these objectives are suggested.     

Cervical cytology quality assurance in Washington State.

The objectives of this study were to establish a profile of cervical cytology laboratories in Washington State, identify quality assurance problems amenable to correction through education or legislation, and describe differences between large and small cytology laboratories. All 43 Washington laboratories that perform cervical cytology were surveyed by mail during 1989. Completed surveys were returned by 37 (86%) of the laboratories. Nearly half (43%) of the respondents reported processing less than 10,000 Papanicolaou smears annually. Only one-third (35%) of the respondents reported participating in relevant proficiency programs. A proportion of smaller cytology laboratories were compensating their cytotechnologists on the basis of the number of slides read and allowing Papanicolaou smears to be read outside the confines of the laboratory. The results of this study suggest that cytotechnologists in some larger Washington laboratories have been exceeding work load limits recommended by professional associations. Recent legislation includes regulations that address cervical cytology quality assurance. However, continued efforts will need to be made to encourage voluntary adoption of quality control measures not addressed by this legislation.     

In-house quality assurance program in a state cytology laboratory

The history and procedures of the Cytology Branch of the North Carolina State Laboratory of Public Health are briefly reviewed, including its quality assurance procedures. The latter consists of (1) programs for education of smear providers (e.g., with printed material), (2) maintenance of optimal working conditions within the laboratory itself and (3) procedures to foster quality of screening (such as proper documentation, 10% rescreening of all negative smears, specimen reviews, educational programs and outside reviews).     

External quality assurance for cervical cytology in developing countries. Experience in Peru and Nicaragua

Given interest from the professionals concerned, an external quality assurance scheme for cervical cytology can successfully be introduced in developing countries. This is a very important precondition if screening programs are to be expanded and decreases in mortality from cervical cancer are to occur in developing countries. Nicaragua and Peru have been experimenting with an external quality assurance system adapted from the Scottish and Northern Ireland scheme. It has been received with enthusiasm and acceptance and has helped cytology laboratories in these countries focusing on quality issues. Nevertheless, a successful quality control scheme that is to result in improvements in the quality of professionals' diagnostic skills needs to be accompanied by a remedial program for subperformers.     

Quality assurance and risk reduction guidelines

Cervical cancer continues to be a major cause of death in women worldwide. The major problem facing most women is the unavailability of screening Pap tests in poor and underdeveloped countries. While rates of cancer deaths have decreased 60-80% in developed countries since the Pap test became available, the accuracy of Paps was challenged recently. In order to instill public confidence and promote optimal patient care, measures to improve the quality of the entire screening process should be undertaken. Continuous quality improvement processes are more appropriate than traditional quality assurance monitors. Although no standards can be defined that are applicable to all laboratory settings and nations, this document provides current views on universal quality procedures and risk reduction. Procedure/policy manuals, workload assessment, hierarchic/peer review, discrepancy analysis, rescreening studies and cytohistologic correlation are examples of universally applicable quality tools. The variability in practices in different parts of the world is also discussed.     

The New Quality Assurance Standard of the Joint Commission on Accreditation of Hospitals

The Joint Commission on Accreditation of Hospitals (JCAH) has continuously emphasized improvement in the quality of care provided in hospitals as the central purpose of the accreditation process. In striving to assure such improvement, the JCAH has stressed the need for, and the responsibility of, the medical and other professional staffs to provide continuing review and evaluation of patient care. In recent years, quality assessment activities have evolved, proliferated and matured to the extent that they require a purposeful integration if they are to effect sustained improvement in patient care and clinical performance. To assist hospitals in the coordination or integration of quality assessment activities, the Board of Commissioners of the JCAH has approved an important new quality assurance standard.Significant requirements of the new standard are a comprehensive quality assurance program, a written plan, a problem-focused approach to the review and evaluation of patient care and clinical performance, an annual reassessment of the program, and an improvement in patient care or clinical performance. The new standard reflects the JCAH belief that an integrated, problem-focused approach to quality assurance will significantly improve the quality of care provided throughout a hospital. Such an approach recognizes the interdependence of hospital departments and services in the provision of patient care, and, therefore, requires a purposeful integration or coordination of quality assessment data and activities. Consequently, quality assessment data may be utilized effectively and efficiently, and many potentially useless or duplicative quality assessment activities can be eliminated. The new standard affords hospitals considerable flexibility in the manner in which they implement and administer the program and encourages innovation.     

Cervical cancer screening programs: summary of the 1982. Canadian task force report.

The Canadian Task Force on Cervical Cancer Screening Programs, which produced its first report in 1976, was reconvened by the Department of National Health and Welfare in 1980 in response to concerns expressed about the significance of new data, changing sociosexual patterns and wide variations in the implementation of the 1976 recommendations. This article is a summary of the 1982 task force report. In addition to updates of the 1976 material new sections appear on groups at risk, mathematical models of screening, quality control in screening programs, cytologic screening coverage of the Canadian population and management of patients with abnormal smears. The 1982 recommendations deal with frequency of screening, laboratory quality control and follow-up mechanisms. The task force concludes that measures to improve the quality and sensitivity of screening programs and to include women who have never been screened will be more effective in reducing mortality from carcinoma of the cervix than will attempts to increase the frequency of screening. The task force views as unnecessary the annual screening of women over 35 years of age whose previous smears have been normal. Since younger women are sexually more active and tend to have more than one sexual partner they are at high risk. Therefore, the task force recommends annual screening for sexually active women aged 18 to 35 years. Physicians, health care professionals and government health agencies have a role to play in informing women about the recommended intervals for cervical smears and ensuring that screening programs of adequate quality are available. Although women are primarily responsible for entering and continuing in such a program, government-sponsored registries are essential if the full potential of cervical smear programs is to be realized.     

Quality assurance in cervical smears: 100% rapid rescreening vs. 10% random rescreening

OBJECTIVE: To compare 100% rapid rescreening of cervical smears with 10% random rescreening as a method of quality assurance. STUDY DESIGN: A total of 5215 smears, randomly selected from smears reported as negative by cytotechnologists during routine screening, underwent 100% rapid rescreening by senior cytotechnologists. Ten percent of these smears, selected at random, were rescreened by other senior cytotechnologists. The gold standard was defined by cytopathologists, who rescreened all 5215 smears. After excluding unsatisfactory smears detected by cytopathologists, 4271 were included in the analysis. RESULTS: The 100% rapid rescreening method identified 69.9%, 95.7% and 100%, respectively, of atypical squamous cells of undetermined significance, low grade squamous intraepithelial lesion and high grade squamous intraepithelial lesion cases reported by the cytopathologists. The 100% rapid rescreening method showed a sensitivity of 73.5% and specificity of 98.6%. The 10% rescreening method showed sensitivity of 40.9% and specificity of 98.8%. CONCLUSION: One hundred percent rapid rescreening is an efficient method of internal quality assurance in cervical smear diagnosis. It can reduce the false negative rate and therefore can provide greater certainty to women who have received negative results. Well-trained cytotechnologists are able to identify abnormal smears in 1-minute rapid rescreening.     

Cervical cancer screening from the public health perspective

Many state health departments have a significant role in cervical cancer screening. Given that role, a group of public health personnel from eight southeastern states drafted a set of questions and quality assurance issues to be discussed with a laboratory under consideration as a contract provider of cytology services. The major points of concern included: (1) quality of laboratory services (accreditation, personnel, facilities and operational and quality control procedures); (2) quality of sampling (including techniques used and the training and monitoring of sample takers); (3) terminology for cytology reporting; and (4) protocols used for diagnostic evaluation of abnormal Papanicolaou smears.     

Cervical cancer screening and demonstration projects to identify barriers to preventing cervical cancer mortality

Cervical cancer screening and demonstration projects to identify barriers to optimal screening are discussed. Interview surveys showed that older women and women in low-income groups tended to have lower rates of Papanicolaou smear screening. Data produced by demonstration projects established by the Centers for Disease Control in collaboration with state and local authorities and private institutions will be used to design and implement strategies for increasing screening levels to further reduce cervical cancer mortality.     

Internal quality assurance in cervical cytology—one laboratory's experience

The results of an internal quality assurance exercise in one cervical cytology laboratory in England are presented, using differing types of partial percentage re-screening of cervical smears. An overall false-negative dyskaryotic rate of up to 4.3% was demonstrated, with the final cytology report diagnosis differing from the primary screening diagnosis in 1.3% of cases. These findings are discussed, with the aim of helping to foster debate on the setting of national laboratory internal quality assurance standards.     

Papanicolaou smears without endocervical cells. Are they inadequate?

The retrieval of columnar endocervical cells from the squamocolumnar junction has generally been considered to be a measure of the adequacy of a Papanicolaou smear; this implies that, if endocervical cells are absent from the smear, the examination for cervical cancer is less than optimal and should be repeated. A study was undertaken to determine if women with serial Papanicolaou smears without endocervical cells showed an increased rate of development of cervical atypia in subsequent smears. The smears of 18,914 women were evaluated for the presence or absence of endocervical cells and for the subsequent development of an abnormal smear over a four-year study period. No differences were found in the rates of atypia between women with and those without endocervical cells on serial Papanicolaou smears. Women with prior Papanicolaou smears without endocervical cells were much more likely to have a subsequent Papanicolaou smear without endocervical cells. Although no difference was found in the incidence of cervical atypia in the two groups during this short study period, these results should be considered to be preliminary.     

Criteria for organized cervical screening programs. Special emphasis on The Netherlands program

Based on the criteria of Wilson and Jungner and experiences in the population-based organized cervical screening program in the Netherlands, conditions for efficient and effective population screening for cervical cancer are described. The purpose of this paper is to determine if these criteria are met for cervical cancer screening and to give recommendations for improvement. Cervical cancer is still an important health problem; the present incidence reflects both background risk and screening activity during previous decades. A positive effect of screening is reached because of the long development time of the disease and the ability of the Pap smear test to detect precancer and early, symptomatic disease. Considerable reduction in the incidence and mortality of cervical cancers can be reached if all women attend and all detected lesions are adequately followed up. Common terminology and classification criteria for histology and cytology should be used. Whether newly developed techniques that may improve or replace cytology can be used in screening programs should be a multidisciplinary decision after clinical trials have given evidence-based information on the performance, cost-effectiveness and need of these techniques. When cervical cancer screening is undertaken, it should be offered in organized programs at the medical level closest to the patients, the general practitioner. High compliance is the most important factor in reducing cervical cancer incidence. Quality control and assurance must be performed at all levels. In the case of limited resources, the program should use a five-year interval and concentrate on the age range 25-60 years, with special attention to women who have never been screened or were screened > 10 years previously. Evaluation of medical and organizational aspects is mandatory. Cooperation between all involved parties is a prerequisite of creating a successful screening program.     

European guidelines for quality assurance in cervical cancer screening: recommendations for cytology laboratories.

The quality of a cervical cytology laboratory depends on adequate handling and staining of the samples, screening and interpretation of the slides and reporting of the results. These guidelines give an overview of procedures recommended in Europe to manage the balance between best patient care possible, laboratory quality assurance and cost effectiveness and will be published as a chapter 4 in the European Guidelines for Quality Assurance in Cervical Cancer Screening. The laboratory guidelines include protocols for personnel and organisation, material requirements, handling and analysing cervical samples, recording of results, quality management and communication. The section on quality management is comprehensive and includes protocols for all aspects of internal and external quality assurance. The guidelines are extensively referenced and as far as possible the recommendations are evidence-based.     

Internal quality assurance in cervical cytology—one laboratory’s experience

The results of an internal quality assurance exercise in one cervical cytology laboratory in England are presented, using differing types of partial percentage re-screening of cervical smears. An overall false-negative dyskaryotic rate of up to 4.3% was demonstrated, with the final cytology report diagnosis differing from the primary screening diagnosis in 1.3% of cases. These findings are discussed, with the aim of helping to foster debate on the setting of national laboratory internal quality assurance standards.     

Screening for the prevention of cervical cancer in the era of human papillomavirus vaccination: an Australian perspective

Australia has a unique and highly successful screening program for cervical cancer which is based on the conventional Pap smear. Since its introduction in 1991 there has been a decline in both the incidence of and mortality from this disease. Part of the success of this program has been the introduction of Pap test registers and strict quality assurance measures for cervical cytology, including compulsory key performance indicators for laboratories. Using these measures, nationwide calculations give cervical cytology in Australia a sensitivity of 78% for high-grade lesions and a positive predictive value (PPV) of 78%. Australia was the first country to introduce a widespread government-funded human papillomavirus (HPV) vaccination program in 2007. Because of the high accuracy of Australian cytology, HPV testing alone, given its low PPV and high cost, is unlikely to be a viable alternative to cytology for primary screening in this country. Australia therefore faces unique issues and choices in integrating its extensive vaccination program with a successful cervical screening program.     

Toward implementation of a regional quality assurance program in cytopathology: the Hong Kong experience

OBJECTIVE: To develop a local quality assurance program in cytopathology based on circulation of patient specimens on glass slides, with limited resources. STUDY DESIGN: A working group was set up for design and running of the program. Participation is on a laboratory basis. The scope and frequency of testing are defined. Well-documented cases (including gynecologic, nongynecologic and fine needle aspiration cytology) with commonly encountered diagnoses are collected. Consensus concerning the diagnosis, interpretive menu and scoring system is sought before the actual slide circulations using express mail. After returning their answers to the program organizer, the participating laboratories receive immediate feedback on their scores, with reference answers, explanatory notes, "whole-mount" images of glass slides and cumulative responses of peer laboratories for on-site checking. At the end of each year, an electronic file containing representative photomicrographs of all cases examined is provided to individual laboratories for their permanent records and training purposes. RESULTS: The program was launched in mid-2003. There were 24 and 27 participating laboratories from Hong Kong (and Macau) in 2003 and 2004, respectively. To date, >150 well-documented cytology cases are available in the slide pool and ready for circulation. As the revenue is mainly to cover the expenses of express mail, the program can be carried out at a relatively low cost. CONCLUSION: In order to have any cytology quality assurance program accepted by local laboratories, it has to be fair and practical. Strict confidentiality needs to be observed throughout the process. This program emphasizes both performance assessment and educational value. Adequate representation from experienced local cytology workers, detailed documentation support from authorities and assistance from dedicated staff are essential to the success of any external proficiency testing scheme. Regular review and evaluation are also necessary for continuous improvement. The Hong Kong experience can serve as an example of running a glass slide-based cytology quality assurance program in a small region with limited resources.     

Finnish cytotechnologists' views on the competencies of newly graduated biomedical scientists in clinical cytology

Objective

This study asked 40 cytotechnologists for their views on the competencies of newly graduated biomedical scientists in clinical cytology during the national conference of the Finnish Association of Cytotechnologists in November 2015.

Methods

The questionnaire mainly consisted of statements that were scored on a five‐point Likert‐scale, where 1 was not important and 5 was very important. It covered five sections of clinical cytology: sampling and techniques, gynaecological screening, non‐gynaecological screening, safety and quality management, and miscellaneous.

Results

Of the 40 delegates approached to complete the questionnaire, 37 (92.5%) agreed. Respondents felt that important sampling and technique competencies were specimen fixation, with a mean score of 4.9 out of 5.0, types of specimens (4.7), Papanicolaou smear collection (4.7), Papanicolaou smear request information (4.7) and evaluation of specimen sufficiency (4.6). Less important competencies were examining FNAs (2.0) and nasopharyngeal specimens (2.2). The respondents had many expectations about how education in cytology could be developed, for example more theoretical lessons, more practice in microscope use, and consistent criteria for training and cooperation between cytology laboratories and universities of applied sciences.

Conclusions

The cytotechnologists who took part in our survey expected newly graduated biomedical scientists to have basic competencies in cytology. These were sampling and techniques, laboratory safety and quality management, specimen adequacy and identifying normal cells taken during gynaecological screening. They were also keen to develop education in cytology.