Objective: We aimed to critically evaluate the importance of quality control (QC) and quality assurance (QA) strategies in the routine work of uterine cervix cytology. Study Design: We revised all the main principles of QC and QA that are already being implemented worldwide and then discussed the positive aspects and limitations of these as well as proposing alternatives when pertinent. Results: A literature review was introduced after highlighting the main historical revisions, and then a critical evaluation of the principal innovations in screening programmes was conducted, with recommendations being postulated. Conclusions: Based on the analysed data, QC and QA are two essential arms that support the quality of a screening programme.

1.
Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A: Global cancer statistics, 2012. CA Cancer J Clin 2015;65:87-108.
2.
DeGroff A, Cheung K, Dawkins-Lyn N, Hall MA, Melillo S, Glover-Kudon R: Identifying promising practices for evaluation: the National Breast and Cervical Cancer Early Detection Program. Cancer Causes Control 2015;26:767-774.
3.
de Jonge V, Sint Nicolaas J, van Leerdam ME, Kuipers EJ: Overview of the quality assurance movement in health care. Best Pract Res Clin Gastroenterol 2011;25:337-347.
4.
Grzybicki DM, Shahangian S, Pollock AM, Raab SS: A summary of deliberations on strategic planning for continuous quality improvement in laboratory medicine. Am J Clin Pathol 2009;131:315-320.
5.
Braithwaite J, Westbrook J, Johnston B, Clark S, Brandon M, Banks M, Hughes C, Greenfield D, Pawsey M, Corbett A, Georgiou A, Callen J, Ovretveit J, Pope C, Suñol R, Shaw C, Debono D, Westbrook M, Hinchcliff R, Moldovan M: Strengthening organizational performance through accreditation research - a framework for twelve interrelated studies: the ACCREDIT project study protocol. BMC Res Notes 2011;4:390.
6.
Saraiya M, Irwin KL, Carlin L, Chen X, Jain N, Benard V, Montano DE: Cervical cancer screening and management practices among providers in the National Breast and Cervical Cancer Early Detection Program (NBCCEDP). Cancer 2007;110:1024-1032.
7.
Naritoku WY, Alexander CB, Bennett BD, Black-Schaffer WS, Brissette MD, Grimes MM, Hoffman RD, Hunt JL, Iezzoni JC, Johnson R, Kozel J, Mendoza RM, Post MD, Powell SZ, Procop GW, Steinberg JJ, Thorsen LM, Nestler SP: The pathology milestones and the next accreditation system. Arch Pathol Lab Med 2014;138:307-315.
8.
Yao K, McKinney B, Murphy A, Rotz P, Wafula W, Sendagire H, Okui S, Nkengasong JN: Improving quality management systems of laboratories in developing countries: an innovative training approach to accelerate laboratory accreditation. Am J Clin Pathol 2010;134:401-409.
9.
Woodcock S, Fine G, McClure K, Unger B, Rizzo-Price P: The role of standards and training in preparing for accreditation. Am J Clin Pathol 2010;134:388-392.
10.
Wilson A: The role of cytotechnologists in quality assurance and audit in non-gynaecological cytology. Cytopathology 2015;26:75-78.
11.
Klazinga N: Re-engineering trust: the adoption and adaption of four models for external quality assurance of health care services in western European health care systems. Int J Qual Health Care 2000;12:183-189.
12.
Branca M, Longatto-Filho A: A Manual for Cervical Cancer Screening and Control. Principles, Practice and New Perspectives. New York, Nova Science Publishers, 2013.
13.
Anderson RJ, Amarasingham R, Pickens SS: The quest for quality: perspectives from the safety net. Front Health Serv Manage 2007;23:15-28.
14.
Cullen R, Mason D: Quality assurance in health sciences literature searching: applying the ISO 9000 quality standard. Health Libr Rev 1995;12:173-189.
15.
Tworek JA, Henry MR, Blond B, Jones BA: College of American Pathologists Gynecologic Cytopathology Quality Consensus Conference on good laboratory practices in gynecologic cytology: background, rationale, and organization. Arch Pathol Lab Med 2013;137:158-163.
16.
Crothers BA, Booth CN, Darragh TM, Zhao C, Souers RJ, Thomas N, Moriarty AT: False-positive Papanicolaou (PAP) test rates in the College of American Pathologists PAP education and PAP proficiency test programs: evaluation of false-positive responses of high-grade squamous intraepithelial lesion or cancer to a negative reference diagnosis. Arch Pathol Lab Med 2014;138:613-619.
17.
Koss LG: The Papanicolaou test for cervical cancer detection. A triumph and a tragedy. J Am Med Assoc 1989;261:737-743.
18.
van der Graaf Y, Vooijs GP: False negative rate in cervical cytology. J Clin Pathol 1987;40:438-442.
19.
Nanda K, McCrory DC, Myers ER, Bastian LA, Hasselblad V, Hickey JD, Matchar DB: Accuracy of the Papanicolaou test in screening for and follow-up of cervical cytologic abnormalities: a systematic review. Ann Intern Med 2000;132:810-819.
20.
Frable WJ: Error reduction and risk management in cytopathology. Semin Diagn Pathol 2007;24:77-88.
21.
Coleman DV, Poznansky JJ: Review of cervical smears from 76 women with invasive cervical cancer: cytological findings and medicolegal implications. Cytopathology 2006;17:127-136.
22.
Renshaw AA: Rescreening in cervical cytology for quality control. When bad data is worse than no data or what works, what doesn't, and why. Clin Lab Med 2003;23:695-708.
23.
Munro A, Leung Y, Spilsbury K, Stewart CJ, Semmens J, Codde J, Williams V, O'Leary P, Steel N, Cohen P: Comparison of cold knife cone biopsy and loop electrosurgical excision procedure in the management of cervical adenocarcinoma in situ: what is the gold standard? Gynecol Oncol 2015;137:258-263.
24.
Dijkstra MG, Snijders PJ, Arbyn M, Rijkaart DC, Berkhof J, Meijer CJ: Cervical cancer screening: on the way to a shift from cytology to full molecular screening. Ann Oncol 2014;25:927-935.
25.
Underwood M, Arbyn M, Parry-Smith W, De Bellis-Ayres S, Todd R, Redman CW, Moss EL: Accuracy of colposcopy-directed punch biopsies: a systematic review and meta-analysis. BJOG 2012;119:1293-1301.
26.
Scapulatempo C, Fregnani JH, Campacci N, Possati-Resende JC, Longatto-Filho A: The significance of augmented high-grade squamous intraepithelial lesion detection on Pap test examination: partial results from the RODEO Study Team. Acta Cytol 2013;57:489-494.
27.
Alves VA, Bibbo M, Schmitt FC, Milanezi F, Longatto Filho A: Comparison of manual and automated methods of liquid-based cytology. A morphologic study. Acta Cytol 2004;48:187-193.
28.
Klug SJ, Neis KJ, Harlfinger W, Malter A, König J, Spieth S, Brinkmann-Smetanay F, Kommoss F, Weyer V, Ikenberg H: A randomized trial comparing conventional cytology to liquid-based cytology and computer assistance. Int J Cancer 2013;132:2849-2857.
29.
Dalla Palma P, Moresco L, Giorgi Rossi P; Working Group Authors: Health technology assessment of computer-assisted Pap test screening in Italy. Acta Cytol 2013;57:349-358.
30.
Longatto-Filho A, Naud P, Derchain SF, Roteli-Martins C, Tatti S, Hammes LS, Sarian LO, Eržen M, Branca M, de Matos JC, Gontijo R, Maeda MY, Lima T, Costa S, Syrjänen S, Syrjänen K: Performance characteristics of Pap test, VIA, VILI, HR-HPV testing, cervicography, and colposcopy in diagnosis of significant cervical pathology. Virchows Arch 2012;460:577-585.
31.
de Bekker-Grob EW, de Kok IM, Bulten J, van Rosmalen J, Vedder JE, Arbyn M, Klinkhamer PJ, Siebers AG, van Ballegooijen M: Liquid-based cervical cytology using ThinPrep technology: weighing the pros and cons in a cost-effectiveness analysis. Cancer Causes Control 2012;23:1323-1331.
32.
Hakama M: Cervical cancer: risk groups for screening. IARC Sci Publ 1986;76:213-219.
33.
Miller AB: Quality assurance in screening strategies. Virus Res 2002;89:295-299.
34.
Longatto-Filho A, Schmitt FC: Gynecological cytology: too old to be a pop star but too young to die. Diagn Cytopathol 2007;35:672-673.
35.
Basu J, Mikhail MS, Palan PR, Payraudeau PH, Romney SL: Factors influencing the exfoliation of cervicovaginal epithelial cells. Am J Obstet Gynecol 1992;167:1904-1909.
36.
Malm P, Balakrishnan BN, Sujathan VK, Kumar R, Bengtsson E: Debris removal in Pap-smear images. Comput Methods Programs Biomed 2013;111:128-138.
37.
Lai CR, Hsu CY, Li AF: Degenerative necrotic endometrial debris in Papanicolaou smears. The role in the prediction of endometrial pathology. Am J Clin Pathol 2012;137:290-294.
38.
Gilani SM, Mazzara PF: Cytohistologic correlation in premenopausal and postmenopausal women. Acta Cytol 2013;57:575-580.
39.
Gupta S, Sodhani P: Reducing ‘atypical squamous cells' overdiagnosis on cervicovaginal smears by diligent cytology screening. Diagn Cytopathol 2012;40:764-769.
40.
Sasieni P, Adams J, Cuzick J: Benefit of cervical screening at different ages: evidence from the UK audit of screening histories. Br J Cancer 2003;89:88-93.
41.
Brouet, N, Eckert LO, Ullrich A, Bloem O: Comprehensive Cervical Cancer Control: A Guide to Essential Practice, ed 2. Geneva, World Health Organisation, 2014.
42.
Longatto-Filho A, Schmitt FC: Cytology education in the 21st century: living in the past or crossing the Rubicon? Acta Cytol 2010;54:654-656.
43.
Stein MD, Fregnani JH, Scapulatempo C, Mafra A, Campacci N, Longatto-Filho A; RODEO Study Team from Barretos Cancer Hospital: Performance and reproducibility of gynecologic cytology interpretation using the FocalPoint system: results of the RODEO Study Team. Am J Clin Pathol 2013;140:567-571.
44.
Ransdell JS, Davey DD, Zaleski S: Clinicopathologic correlation of the unsatisfactory Papanicolaou smear. Cancer 1997;81:139-143.
45.
Nayar R, Wilbur DC: The Pap test and Bethesda 2014. Cancer Cytopathol 2015;123:271-281.
46.
Utagawa ML, di Loreto C, de Freitas C, Milanezi F, Longatto Filho A, Pereira SM, Maeda MY, Schmitt FC: Pero Vaz de Caminha: an interchange program for quality control between Brazil and Portugal. Acta Cytol 2006;50:303-308.
47.
Renshaw AA, Elsheikh TM: Assessment of manual workload limits in gynecologic cytology: reconciling data from 3 major prospective trials of automated screening devices. Am J Clin Pathol 2013;139:428-433.
48.
Alderisio M, Branca M, Erzen M, Longatto-Filho A, Derchain S, Tatti S, Vighi S, Roteli-Martins C, Leoncini L, Maeda MY, Montis D, Gontijo R, Sarian LO, Syrjänen K: Interlaboratory quality control in gynecologic cytopathology using the novel CONQUISTADOR software. Interobserver reproducibility in the Latin American screening study. Acta Cytol 2007;51:872-881.
49.
Renshaw AA: Quality improvement in cytology: where do we go from here? Arch Pathol Lab Med 2011;135:1387-1390.
50.
Mody DR, Davey DD, Branca M, et al: Quality assurance and risk reduction guidelines. Acta Cytol 2000;44:496-507.
51.
Schneider V, Henry MR, Jimenez-Ayala M, Turnbull LS, Wright TC; International Consensus Conference on the Fight Against Cervical Cancer; IAC Task Force: Cervical cancer screening, screening errors and reporting. Acta Cytol 2001;45:493-498.
52.
Herbert A, Anic V, Cochand-Priollet B, Dina R, Ehya H, Eide ML, Fabre M, Field A, Kapila K, Kardum-Skelin I, Oliveira MH, Olszewski W, Onal B, Nasioutziki M, Nayar R, Nielsen K, Shabalova I, Schmitt F, Tötsch M, Wilson A, Vass L, Zeppa P: Training and practice of cytotechnologists: a discussion forum focused on Europe. Cytopathology 2014;25:307-315.
53.
Branca M, Morosini PL, Marsan C, Coleman D: Quality assurance and continuous quality improvement in laboratories which undertake cervical screening. Leonardo da Vinci project - CYTOTRAIN 1996-2002, Istituto Superiore di Sanità, Rome, 2002, pp 1-39.
54.
Iezzoni JC, Ewton A, Chévez-Barrios P, Moore S, Thorsen LM, Naritoku WY: Selective pathology fellowships: diverse, innovative, and valuable subspecialty training. Arch Pathol Lab Med 2014;138:518-525.
55.
Armstrong KA, Semple JL, Coyte PC: Replacing ambulatory surgical follow-up visits with mobile app home monitoring: modeling cost-effective scenarios. J Med Internet Res 2014;16:e213.
56.
Kumagai AK, Wear D: ‘Making strange': a role for the humanities in medical education. Acad Med 2014;89:973-977.
57.
Menchik DA: Decisions about knowledge in medical practice: the effect of temporal features of a task. AJS 2014;120:701-749.
58.
Gibson CJ, Dixon BE, Abrams K: Convergent evolution of health information management and health informatics: a perspective on the future of information professionals in health care. Appl Clin Inform 2015;6:163-184.
59.
Branca M, Morosini PL, Duca PG, et al: Reliability and accuracy in reporting CIN in 14 laboratories. Developing new indices of diagnostic variability in an interlaboratory study. Acta Cytol 1998;42,1370-1376.
60.
Branca M, Morosini P, Severi P, Erzen M, Di Benedetto C, Syrjänen K: New statistical software for intralaboratory and interlaboratory quality control in clinical cytology. Validation in a simulation study on clinical samples. Acta Cytol 2005;49:398-404.
Copyright / Drug Dosage / Disclaimer
Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher.
Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.
You do not currently have access to this content.