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Analysis of Addenda in Anatomic Pathology as a Quality Monitoring Initiative.

An addendum report is commonly defined as a secondarily issued report that provides supplementary information to the original report. (1,2) Along with the integration of immunohistochemical markers and molecular techniques into routine practice, addenda in surgical pathology reporting have not only increased in frequency but also evolved from supplementing purely diagnostic information to including clinically relevant prognostic and therapeutic information. (3) Amended reports have classically been reserved for significant modifications to a previously released pathology report and are monitored as a standard component of quality assurance programs. (4) Although amendments have been defined in the literature, (5) previous studies (6,7) have demonstrated that pathologists disagree significantly with respect to when an amended report is warranted. Because of the lack of uniform practice, information that can significantly change the diagnosis, prognosis, or treatment plan may be issued as an addendum as opposed to an amendment. Owing to the differing ways in which amendments and addenda are presented in pathology reports and electronic patient record systems, communicating significant unanticipated information as an addendum may have serious implications for patient care. Amendments are typically given greater emphasis, usually replacing original reports in electronic patient care systems, and are often accompanied by additional notification to clinicians. Addenda, on the other hand, often appear at the bottom of reports and are not accompanied by additional notification steps. Unanticipated changes to critical information, therefore, are more easily overlooked by clinicians when reported as addenda.

OBJECTIVE

The central objective of this study is to audit surgical pathology, cytology, and autopsy addenda reports in the pathology laboratory of an academic tertiary health care center to identify instances where addenda were inappropriately used to convey information that changed a report's diagnostic, prognostic, or therapeutic meaning. It is our premise that such information that comes to light after an original surgical pathology report has been issued requires an amended report.

DESIGN

All addendum reports and the corresponding originally issued reports for autopsy, cytology, and surgical pathology cases at an academic tertiary care pathology laboratory in Toronto, Ontario, Canada, during a 36-month period, from January 1, 2008, through December 31, 2010, were retrieved, reviewed, and initially categorized by a pathologist in a nonblinded fashion. After review, each addendum report was classified by accession class (autopsy, cytology, surgical pathology), issuing pathologist, subspecialty category, indication for addendum, and whether or not the contents of the addendum represented a change in the report's diagnostic, prognostic, or therapeutic meaning. The indication of all surgical pathology and cytology amendments over the course of the defined 36-month period was also reviewed for comparison.

All staff pathologists from all subspecialty areas available at our institution were included and grouped according to the following subspecialty categories: gastrointestinal, genitourinary, medical renal, dermatopathology, breast, gynecologic, cardiovascular, oral, orthopaedic, pulmonary, lymphoma/hematopathology, neuropathology, sarcoma and soft tissue, head and neck, and placenta. The indications for addenda reports considered included additional hematoxylin-eosin (H&E) sections, decalcification, missing parts or missing data, reporting of special histochemical stains (i.e., gram stain, periodic acid-Schiff stain with diastase), reporting of diagnostic immunohistochemical studies, reporting of prognostic biomarkers, reporting of results of molecular studies, reporting of electron microscopy study, reporting of immunofluorescence study, reporting of cytogenetics, review of external archival material, review of internal archival material, external consultation, intradepartmental consultation, disposition of material, autopsy neuropathology procedure/report, microsatellite instability reporting, clinician-requested review, significant omission (omitting information that would change treatment or prognosis; eg, omitting reporting a positive resection margin in a skin resection specimen for melanoma), minor omission (omitting information that would have no impact on treatment or prognosis of the patient; eg, reporting an incidental seborrheic keratosis in a skin resection specimen for invasive squamous cell carcinoma), disagreement with consultant, and other. Cytology addenda were further stratified as gynecologic cytology cases, nongynecologic fine-needle aspiration (FNA) cases, and nongynecologic non-FNA cases.

A change in diagnostic meaning was considered to have occurred when a different diagnosis was stated in the addendum that contradicted the primary diagnosis in the original report (eg, change from a benign diagnosis to malignant diagnosis or vice versa). A change in prognosis was considered to occur when the supplemental information significantly impacted the prognosis of the original diagnosis (eg, diagnostic immunohistochemistry proves micrometastatic nodal disease in sentinel axillary nodes after the case was finalized and released as negative for lymph node metastases). A change in implication for treatment included situations where the supplemental information provided in the addenda required action from the clinical management team, such as further surgery, adjuvant therapy, or discontinuing an already initiated treatment (eg, after release of a surgical pathology report, lymphovascular invasion is identified upon receipt of additional diagnostic immunohistochemical studies, and adjuvant chemotherapy would need to be initiated solely on this additional information). All reports identified as suggesting a change in diagnostic meaning, prognosis, or implications for treatment were reviewed in conjunction with any available clinical information by a second expert surgical pathologist. Addendum reports were labeled as misclassified only after consensus agreement between both reviewing pathologists upon completion of the review and discussion of the content, clinical context, and clinical ramification of the reports. Originally issued final reports that contained clear information about pending ancillary studies, and indicating that a subsequent addenda report was going to be issued with the results of these studies, were considered to be reported appropriately.

RESULTS

A total of 7464 addendum reports were identified for the defined 36-month period. Autopsy cases accounted for 135 addenda that were appropriately reported to primarily include details of neuropathologic examination (70.9%), reporting of an external consultation (8.7%), and reporting of molecular studies (6.8%). In all, 2301 addenda were issued for cytology cases during the 36-month period, including 2183 gynecologic cytology cases, 50 nongynecologic FNA cases, and 68 nongynecologic non-FNA cases (eg, peritoneal fluid aspiration). The primary indications for cytology addenda were the reporting of human papillomavirus molecular studies (95.1%), reporting of diagnostic immunohistochemical studies (3.0%), and reporting of special histochemical stains (0.6%). All addenda for cytologic cases were appropriately reported. In all, 5028 addenda for surgical pathology cases were issued, primarily by the breast site group (44.1%), and followed by the gastrointestinal site group (12.1%), dermatopathology service (11.0%), and neuropathology service (8.3%). The primary indications for issuing a surgical pathology addendum (Table 1) were reporting of a prognostic biochemical marker (42.4%), reporting of molecular studies (15.7%), reporting of diagnostic immunohistochemical studies (11.8%), reporting of histochemical stains (4.2%), and reporting of external consultations (3.9%).

None of the 135 autopsy or 2301 cytology addenda were deemed to have changed the initial diagnostic meaning, prognosis, or treatment implications of the primary report.

Thirty-three surgical pathology addenda over the defined time period were identified and deemed to contain information that warranted an amended report. The rate of surgical pathology faux addenda was 0.28 per 1000 cases for 2008, 0.37 per 1000 cases for 2009, and 0.37 per 1000 cases for 2010. Eight of these 33 addenda (24.2%) were by consensus determined to be a change in diagnosis. Thirty of the surgical pathology addenda contained supplemental information that would significantly alter patient management and 31 of the addenda had additional information that would significantly change the prognosis. Breast cases accounted for 30.6% of the faux addenda (Table 2), while 17.6% were dermatopathology cases, with gynecologic and gastrointestinal cases accounting for 15.7% each. The primary indications for the faux addenda (Table 3) included reporting of diagnostic immunohistochemical studies (12 of 33 faux addenda), reporting a significant omission (11 of 33 faux addenda), reporting results of additional H&E sections (4 of 33 faux addenda), reporting of decalcified sections (1 of 33 faux addenda), and reporting of special histochemical studies (1 of 33 faux addenda). Our review identifies that 17 of 33 (51.5%) faux addenda were issued before receipt and review of diagnostic immunohistochemical studies (12 of 33 faux addenda), additional H&E sections (4 of 33 faux addenda), or reporting of special histochemical staining (1 of 33 faux addenda). Although 11 individual pathologists had issued faux addenda, a single pathologist was responsible for 8 of the 33 (24.2%) misclassified cases. Examples of faux addenda are provided in Table 4.

During a 36-month period encompassing January 1, 2008, through December 31, 2010, 499 surgical pathology amendments were issued at a rate of 0.5 amendments per 1000 surgical pathology cases, including in-house and consultation cases. Two hundred eighty-six amendments (57.3%) were issued to change the final diagnosis or comment. Thirty one (6.2%) surgical pathology amendments were issued to report a change in the macroscopic description, and 58 (11.6%) were submitted to report a change in the microscopic description. One hundred nine (21.8%) amendments were found to be issued to correct clinical information and 15 (3.0%) to correct patient identification. During the same 36-month period, 58 amendments were issued for cytology class specimens at a rate of 0.69 amendments per 1000 cytology cases including both gynecologic and nongynecologic cases. Thirty-five of the 58 amendments (60.3%) were issued to change the diagnosis or comment and 14 (24.1%) were issued to correct clinical information. The remaining cytology amendments were issued to change the macroscopic description (3 amendments, 5.1%), to change the microscopic description (5 amendments, 8.6%), and to correct patient identification (1 amendment, 1.7%).

COMMENT

This review of 7464 autopsy, cytology, and surgical pathology addendum reports issued during a continuous 36-month period is one of the largest documented analyses of its kind. Our study documents the pattern of use and frequency of autopsy and cytology addendum reports and verifies that they are truly supplemental in nature. More importantly, it demonstrates that surgical pathology addenda may contain key diagnostic, prognostic, or treatment-related information that differs from the primary report. This study advances the concept that the usual practice of monitoring only reports designated as amendments likely underestimates true amendment rates, because some amendments masquerade as addenda.

Documenting the amendment rate of surgical pathology reports is a standard component of internal quality assurance programs. In a College of American Pathologists Q-Probes study, Nakhleh et al (1) quantified the number of amended reports reported by laboratories and suggested that laboratories should aim to reach the "best practice" benchmark of 0.22 amended reports per 1000 surgical pathology reports. In our study, the rate of surgical pathology addenda that met the common criterion for an amendment was 0.28 per 1000 cases for 2008, 0.37 per 1000 cases for 2009, and 0.37 per 1000 cases for 2010. The data from this study argue that amendment rates per 1000 cases are understated if addenda are not monitored. Addenda need to be monitored to detect faux addenda that are really amendments. These changes must be added to numerators of amendment rates.

The length of time from receipt of a specimen to issuance of a final surgical pathology report is understandably constantly monitored as a standard quality indicator in surgical pathology practice. With the increasing integration of immunohistochemical biomarker testing and diagnostic molecular techniques into everyday practice, ancillary tools for diagnosis are more frequently requested. In a high-volume tertiary care center, ancillary studies, such as immunohistochemical studies, decalcification of tissue blocks, and molecular techniques, may take many days to complete. To avoid negatively impacting the time to diagnosis, surgical pathology reports are often issued with additional studies still pending. In our review, it was found that 12 of 33 faux addenda (36.4%) were issued for the reporting of a diagnostic immunohistochemical study and 4 of 33 faux surgical pathology addenda (12.1%) were issued for additional H&E sections. In surgical pathology cases where diagnostic immunohistochemical markers or additional sections have been requested, when the outcome has the potential to change either the fundamental diagnosis, prognosis, or treatment plan, in our practice it is advised that the final surgical pathology report not be released until these studies have been completed and reviewed. The data from our internal review identify that 17 of the 33 unmonitored misclassified supplemental reports (51.5%) could have been prevented by the practice of holding the release of the final surgical pathology report until receipt and complete review of all diagnostic immunohistochemical studies, special histochemical stains, and additional H&E sections. The additional wait time for additional immunohistochemical markers, histochemical stains, and H&E sections on a small subset of cases will in most circumstances not have a significant impact on immediate patient care or a pathologist's global turnaround time. It is recognized, however, that situations arise where rapidity of diagnosis is paramount. In this circumstance, strong communication with the clinical management team is required, and caution should be used when wording the preliminary report and diagnosis to ideally incorporate the working differential diagnosis, a listing of pending ancillary tests, and notification of a pending supplemental report with the results of the pending ancillary tests.

As clinical decisions or actions may have been initiated from the initial final diagnosis, it is required under the College of American Pathologists Commission on Laboratory Accreditation Laboratory Accreditation Program (GEN.41310, phase II) (1) that previous information be immediately available for comparison with the revised information in the supplemental report. Under this requirement, the initial report and the supplemental report must be identified as such, and the original data must be present in the revised report, or linked electronically or logically to the revised report. It is vital that pathologists be aware of how the laboratory information system interfaces with the hospital electronic patient record and specifically, how supplemental reports are presented to the clinical management team. In many systems, addenda appear at the bottom of the report, and thus may easily go undetected by the reader who does not look beyond the "final diagnosis" section of the report. In contrast, amended reports typically replace the content of the original report with the content of the corrected report. In addition, many departments have additional policies in place to ensure prompt notification of clinicians when amended reports are issued, but such policies are generally not applied to addendum reports. Given the observed frequency of faux addenda, it is plausible that suboptimal communication of supplemental addendum reports may be a preventable source of postanalytic error that may result in delay of appropriate treatment or initiation of inappropriate therapy.

Our study corroborates the findings of Finkelstein et al (3) in that surgical pathology addenda may contain information that significantly alters or contradicts the original report. The current study encompassed 3 consecutive years of addenda, which included all specimen classes (surgical pathology, cytology, and autopsy), while the study of Finkelstein et al (3) examined surgical pathology addenda during 4 discontinuous months spread across more than a decade. Our expanded data set suggests that faux addenda appear to be an issue primarily in surgical pathology and thus, monitoring efforts should focus on this division of laboratory medicine. Within surgical pathology, our rates of faux addenda were significantly lower than those found by Finkelstein et al, (3) but still higher than the "best practice" benchmark of 0.22 amended reports per 1000 surgical pathology reports suggested by a College of American Pathologists Q-Probes study. (1) The difference in rates of faux addenda between the 2 studies may reflect institutional differences or differences in practice patterns in different time periods, as a segment of the data of Finkelstein et al (3) encompassed months within a period spanning more than a decade.

Similar to the opinion put forward by Finkelstein et al, (3) it is also our impression that addenda reports receive less urgent attention by pathologists in comparison to final reports. Causes of this pattern of behavior may be the failure of pending addenda reports to be prioritized on a pathologist's work list created by our institutions' laboratory information system, and the fact that incoming workload requiring evaluation may be given priority and addendum report turnaround times are not monitored as a routine quality indicator. Given the inherent limitation of a single institution study and variability of practice patterns among institutions, the source of this trend will likely vary between laboratories.

CONCLUSIONS

With the advancement and integration of ancillary techniques into routine practice, addenda in pathology reporting have not only increased in frequency but also evolved from supplementing purely diagnostic information to including clinically relevant prognostic and therapeutic information. The lack of standardized practice for issuance of supplemental reports has created a source of confusion for practicing pathologists and a genuine opportunity to misclassify a supplemental report. While most addenda are truly supplemental in nature, a subset of surgical pathology addenda contains important information that should replace some components of the original surgical pathology report in the form of an amended report. Our study demonstrates that faux addenda in surgical pathology occur at a frequency that is comparable to accepted amendment rates per 1000 cases. It is noteworthy that most of these reports were necessary because pathologists signed out reports before receiving all slides and special stains associated with the case. Addressing the issue of amendments that masquerade as addenda is of importance owing to the differing ways in which these results are communicated. Educational efforts should focus on reviewing all sections and stains before issuing the final report; policies should define when an amendment is necessary, and adherence to this policy should be monitored to provide clarity and ensure patient safety.

References

(1.) Nakhleh RE, Zarbo RJ. Amended reports in surgical pathology and implications for diagnostic error detection and avoidance: a College of American Pathologists Q-Probes study of 1,667,547 accessioned cases in 359 laboratories. Arch Pathol Lab Med. 1998; 122(4):303-309.

(2.) Goldsmith JD, Siegal GP, Suster S, et al. Reporting guidelines for clinical laboratory reports in surgical pathology. Arch Pathol Lab Med. 2008; 132(10): 1608-1616.

(3.) Finkelstein A, Levy GH, Cohen P, et al. Addenda in pathology reports: trends and their implications. Am J Clin Pathol. 2012; 137(4):606-611.

(4.) Roy JE, Hunt JL. Detection and classification of diagnostic discrepancies in surgical pathology. Adv Anat Pathol. 2010; 17(5):359-365.

(5.) 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.

(6.) Cooper K. Errors and error rates in surgical pathology: an Association of Directors of Anatomic and Surgical Pathology survey. Arch Pathol Lab Med. 2006; 130(5):607-609.

(7.) Stastny JF, Geisinger KR, Michael CW, et al. Another quality assurance issue: amended reports: what do we really know about them? Diagn Cytopathol. 1998; 18(1):67-70.

(8.) College of American Pathologists. Commission on Laboratory Accreditation: Laboratory General and Anatomic Pathology Checklists. Northfield, IL: College of American Pathologists; 2005.

Jesse Paul Babwah, MD; Mahmoud Khalifa, MSc, MBBCh, PhD; Corwyn Rowsell, MD

Accepted for publication January 24, 2014.

From the Department of Laboratory Medicine and Pathobiology, The University of Toronto, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.

The authors have no relevant financial interest in the products or companies described in this article.

Reprints: Jesse Paul Babwah, MD, Department of Laboratory Medicine and Pathobiology, The University of Toronto, Sunnybrook Health Sciences Centre, 2075 Bayview Ave, Room E4-32, Toronto, ON M4N 3M5, Canada (e-mail: jesse.babwah@utoronto.ca).
Table 1. Breakdown of Surgical Pathology Addenda per Year

Indication                                2008    2009    2010   Total
                                          No.     No.     No.     No.
                                           of      of      of      of
                                         Cases   Cases   Cases   Cases

Additional H&E sections                     43      36      32     111
Decalcification                             48      36      41     125
Missing parts or missing data               28      14      32      74
Reporting of special histochemical          49      67      96     212
  stains (ie, PASD)
Reporting of IHC studies (diagnostic)      208     190     197     595
Reporting of prognostic biomarker          786     782     555    2123
Reporting of results of molecular          204     194     394     792
  studies
Reporting of electron microscopy study      61      71      50     182
Reporting of immunofluorescence study       12      33      61     106
Reporting of cytogenetics                   28      29      49     106
Review of archival material (external)       2       1      10      13
Review of archival material (internal)       0       1       0       1
External consultation                       72      66      59     197
Intradepartmental consultation               9      22      21      52
Disposition of material                      3       0       3       6
Autopsy-neuropathology procedure/            0       0      23      23
  report
Fetal autopsy                                9       9       7      25
Microsatellite instability IHC              25      27      28      80
Clinician-requested review                  14      14       6      34
Significant omission                         4      10       2      16
Minor omission                              31      19       2      52
Disagreement with consultant                 0       0       0       0
Other                                       28      21      54     103
Total surgical pathology addenda by       1664    1642    1722    5028
  indication

Abbreviations: H&E, hematoxylin-eosin stain; IHC,
immunohistochemistry; PASD, periodic acid--Schiff diastase stain.

Table 2. List of Addenda Better Reported as Amendments by Site
Group per Year

Site Group                             2008    2009    2010   Total
                                       No.     No.     No.     No.
                                        of      of      of      of
                                      Cases   Cases   Cases   Cases

Gastrointestinal and hepatobiliary      2       2       1       5
Genitourinary (surgical)                1       2       0       3
Skin                                    1       3       2       6
Breast                                  3       3       4      10
Female genital tract                    2       1       2       5
Lymphoma                                0       0       1       1
Head and neck                           0       1       2       3
Total flagged addenda by site group     9      12      12      33
  (surgical pathology)

Table 3. List of Faux Addenda by Indication per Year

                                      2008    2009    2010   Total
General Criteria                      No.     No.     No.     No.
                                       of      of      of      of
                                     Cases   Cases   Cases   Cases

Additional H&E sections                0       0       4       4
Decalcification                        0       0       1       1
Reporting of special histochemical     0       1       0       1
  stains (ie, PASD)
Reporting of IHC studies               4       5       3      12
  (diagnostic)
Intradepartmental consultation         0       0       1       1
Clinician-requested review             1       0       0       1
Significant omission                   3       6       2      11
Other                                  1       0       1       2
Total flagged surgical pathology       9      12      12      33
  addenda by indication

Abbreviations: H&E, hematoxylin-eosin stain; IHC,
immunohistochemistry; PASD, periodic acid-Schiff diastase stain.

Table 4. Examples of Addenda Better Reported as Amendments

Specimen Type     Original Final           Addendum Text
                  Diagnosis

Prostatectomy     Adenocarcinoma,          Tumor is present
                  Gleason score 4 + 3 =    focally at the left
                  7 (with synoptic         peripheral margin at
                  report)                  the base of the
                                           prostate.

Cervix biopsy     Endometrioid             The tumor cells are
                  adenocarcinoma, high     positive for CDX-2 and
                  grade                    CK20, negative for CK7
                                           and ER. The staining
                                           pattern favors
                                           metastatic colorectal
                                           carcinoma.

Total             Nodular hyperplasia      Occult papillary
thyroidectomy                              thyroid carcinoma (0.8
                                           cm).

Resection of      Acute inflammatory       Colonic adenocarcinoma
ileorectal        infiltrate on serosal    (with synoptic
anastomosis       surface; 8 lymph nodes   report).
                  with no evidence of
                  malignancy

Sentinel lymph    Tiny fragment of         Recut slides and IHC
node dissection   crushed lymphoid         studies (S100 and
for melanoma      tissue, negative for     MART-1) showed
                  malignancy               positivity for
                                           malignant melanoma.

Breast core       Infiltrating lobular     E-cadherin test was
biopsy            carcinoma,               performed and the
                  intermediate nuclear     small focus of
                  grade (2/3)              invasive carcinoma
                                           shows membranous
                                           staining. This pattern
                                           supports the ductal,
                                           not lobular, type. The
                                           diagnosis is
                                           finalized.

Colon             Nonspecific chronic      Poorly differentiated
endoscopic        inflammation and edema   carcinoma, consistent
biopsy                                     with metastatic
                                           carcinoma.

Random gastric    Small-bowel mucosa       Amyloidosis
biopsy            with no significant
                  histologic abnormality

Specimen Type     Indication for         Comment
                  Addendum

Prostatectomy     Significant omission   The positive margin
                                         status was not
                                         reported in the
                                         initial pathology
                                         report.

Cervix biopsy     Reporting of           The initial report was
                  diagnostic IHC         signed out before
                  studies                receiving diagnostic
                                         IHC. The initial
                                         report did not
                                         indicate that IHC
                                         results, which
                                         potentially can change
                                         the diagnosis, were
                                         pending.

Total             Pending decalcified    The initial report had
thyroidectomy     sections               a benign final
                                         diagnosis and did not
                                         indicate decalcified
                                         sections were pending.

Resection of      Clinician-requested    Discordance with the
ileorectal        review                 clinical presentation
anastomosis                              prompted a request by
                                         the clinician to
                                         review the specimen
                                         grossly and
                                         microscopically.

Sentinel lymph    Reporting of           The initial report was
node dissection   additional H&E         signed out as negative
for melanoma      slides and IHC         for malignancy before
                  studies                receiving additional
                                         H&E slides and
                                         additional diagnostic
                                         IHC. Additional
                                         studies demonstrate
                                         metastatic disease.

Breast core       Reporting of           The initial report was
biopsy            diagnostic IHC         signed out as invasive
                  studies                lobular carcinoma.
                                         There was no mention
                                         on the initial report
                                         of pending diagnostic
                                         IHC (E-cadherin).

Colon             Reporting of           The history of a
endoscopic        diagnostic IHC         gastric mass prompted
biopsy            studies                IHC for the colon
                                         biopsy sample. The
                                         initial report was
                                         issued before
                                         receiving IHC results.
                                         There was no
                                         indication of pending
                                         studies.

Random gastric    Reporting of           The initial diagnosis
biopsy            histochemical          did not report an
                  stains                 abnormality.

Abbreviations: CDX-2, homeobox protein CDX-2; CK, cytokeratin;
ER, estrogen receptor; H&E, hematoxylin-eosin stain; IHC,
immunohistochemistry; MART-1, melanoma antigen recognized
by T-cells 1.
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Author:Babwah, Jesse Paul; Khalifa, Mahmoud; Rowsell, Corwyn
Publication:Archives of Pathology & Laboratory Medicine
Date:Nov 1, 2014
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