Editors: Olga Pozdnyakova, MD, PhD, Geoffrey Wool, MD, PhD, David Bernard, MD, PhD & Raul S. Gonzalez, MD
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Q. In a CAP TODAY Q&A (published in August 2024), it was stated that a correlation between an automated and manual white blood cell count is not needed in clinical practice. Does this apply to digital imaging analyzers, such as those from CellaVision and Scopio, as well? If correlations between digital and manual differentials are required, what are your recommendations for acceptability?
A. January 2025—The original question was related to comparison studies of the same patient using a manual and automated differential. Therefore, the statement that correlation “is not needed in clinical practice” relates to comparison studies for one patient using different methods.
Correlation studies should be conducted because they are important for evaluating the performance of a test. Digital analyzers, such as those from CellaVision and Scopio, are used to aid in identifying cells and require manual review in case of a disagreement. After initial validation, the correlation between digital imaging analyzers and manual differential counts, and the criteria for acceptability, should be determined based on your laboratory data.
Danielle L. V. Maracaja, MD, MHS
Clinical Associate Professor of Pathology and Laboratory Medicine
University of North Carolina at Chapel Hill
Member, CAP Hematology/Clinical Microscopy Committee
Q. When we write pathology reports, especially for prostatectomies, our diagnostic lines are often long, per CAP checklist requirements. In some cases, we retrim the surgical margins to evaluate the distal margins and note in the diagnostic line that margins will be studied further. When we report the margin status after retrimming, we are compelled to amend the report, leading to a large and somewhat confusing report because our long diagnostic lines are repeated; the only difference is the single line of the surgical margin. Do you have recommendations for creating an amended versus addendum report and addressing how the report can be more focused for clinicians and patients?
A. Laboratories should amend a report when new information changes the content of a previously issued final report to prevent a patient from being harmed by inadvertent oversight of a clinically relevant finding.1 Conversely, laboratories should issue an addendum when additional information supplements a previously issued final report.
When the primary report states that additional information is pending, an addendum is appropriate as it does not correct the previously issued information. However, in certain situations that require adding information, issuing an amendment may be prudent based on the significance of the finding. For example, if special stains that were pending end up revealing mycobacteria, an amended report may be preferable to ensure that the clinician does not miss this finding.
Per the CAP cancer protocols, a laboratory must issue an amended or addendum report when required data elements are missing or when other omissions or errors may adversely affect patient care (ANP.12350, note No. 8).2 For reports with extensive contextual and interpretive data, CAP checklist requirement ANP.12185 states that laboratories may provide a comment in the amended report summarizing the previous information and the reason for the amendment.3 However, this action requires thoughtful consideration and close collaboration with institutional leadership, stakeholder clinicians, and information technology staff as some EHR systems overwrite previously issued reports with the amended version. This could deprive subsequent clinicians of necessary information if the amended report provides only a limited summary of the prior report. Additionally, this could result in patients being excluded from data sets in institutions where the synoptic format serves as the final diagnosis.
The use of addenda and amendments in contemporary practice has created challenges for pathologists. Many report an uptick in amended reports due to an increase in errors arising from the numerous required data elements in synoptic reporting and the need to integrate asynchronous test results from additional studies into a comprehensive final diagnosis.4
Given the complexities surrounding amendments and addenda in pathology reports, the CAP has convened a Surgical Pathology Committee working group to identify practices for adding new information to reports that better align with contemporary pathology practice.
- Meier FA, Zarbo RJ, Varney RC, et al. Amended reports: development and validation of a taxonomy of defects. Am J Clin Pathol. 2008;130(2):238–246.
- College of American Pathologists. ANP.12350 Cancer protocols. In: Anatomic pathology checklist. Dec. 26, 2024.
- College of American Pathologists. ANP.12185 Amended reports. In: Anatomic pathology checklist. Dec. 26, 2024.
- Renshaw AA, Gould EW. The cost of synoptic reporting. Arch Pathol Lab Med. 2017;141(1):15–16.
Vinita Parkash, MBBS, MPH
Associate Professor of Pathology
Yale University School of Medicine
New Haven, Conn.
Former Vice Chair, CAP Surgical Pathology Committee
Nadine S. Aguilera, MD
Professor of Pathology
University of Virginia School of Medicine
Charlottesville, Va.
Member, CAP Surgical Pathology Committee
Nicole D. Riddle, MD, MSHI
Shareholder Pathologist
Tampa General Hospital
Ruffolo, Hooper, and Associates
Associate Professor
University of South Florida Health
Morsani College of Medicine
Tampa, Fla.
Former Member, CAP Surgical Pathology Committee