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Five-year retrospective review in gynecologic cytopathology: is it time to amend?

Laila Nomani1, Schuharazad Abro1, Grazina Chatt1

  • 1Department of Pathology and Laboratory Medicine, Loyola University Healthcare System, Maywood, Illinois.

Journal of the American Society of Cytopathology
|January 10, 2021
PubMed
Abstract

Insights

The mandatory 5-year retrospective review (5YRR) of Papanicolaou tests for high-grade squamous intraepithelial lesions (HSIL+) showed a low major discrepancy rate of 0.43%. This review process is crucial for quality assurance in gynecologic cytology.

Area of Science:

  • Cytopathology
  • Gynecologic Oncology
  • Quality Assurance in Healthcare

Background:

  • The Clinical Laboratory Improvement Amendments of 1988 mandate a 5-year retrospective review (5YRR) of normal Papanicolaou tests for patients with newly diagnosed high-grade squamous intraepithelial lesions or above (HSIL+).
  • Significant advancements in cervical cancer screening and management guidelines have occurred since this mandate was implemented.
  • The value and efficiency of this mandatory review process in modern cytopathology practice require assessment.

Purpose of the Study:

  • To evaluate the role and impact of the mandatory 5YRR in identifying discrepancies within a specific laboratory setting.
  • To investigate the practical lessons learned from implementing the 5YRR in accordance with current cervical cancer screening protocols.
  • To assess the overall effectiveness of the 5YRR as a quality indicator in gynecologic cytology.

Main Methods:

  • A retrospective search of the cytopathology electronic database and quality assurance records was conducted at Loyola University Medical Center.
  • The study period spanned from January 2009 to December 2019, identifying all Papanicolaou tests diagnosed as HSIL+.
  • Major discrepancies were defined as initial negative diagnoses subsequently changed to HSIL+ upon review.

Main Results:

  • Out of 153,083 Papanicolaou tests, 1452 (0.94%) were diagnosed as HSIL+.
  • Among 695 HSIL+ cases with prior negative Papanicolaou tests, 615 showed agreement.
  • A major discrepancy rate of 0.43% (3 out of 695 cases) was observed, with no amended reports required.

Conclusions:

  • The 5-year retrospective review (5YRR) process, while mandatory, yielded a low rate of major discrepancies in this study.
  • Revisiting the 5YRR is essential to ensure its continued value as a quality indicator in gynecologic cytology.
  • Optimizing the 5YRR process is necessary to maintain its effectiveness without imposing an undue burden on cytology laboratories and personnel.
Keywords:
Gynecologic cytologyLegislationPap testQuality assuranceRegulatory issuesRetrospective review

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