CME/SAM. Measures of Completeness and Accuracy of Clinical Information in Skin Biopsy Requisition Forms An Analysis of 249 Cases

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1 Measures of Completeness and Accuracy of Clinical Information in Skin Biopsy Requisition Forms An Analysis of 249 Cases Ryan C. Romano, DO, 1 Paul J. Novotny, MS, 2 Jeff A. Sloan, PhD, 2 and Nneka I. Comfere, MD 1,3 From the Departments of 1 Laboratory Medicine and Pathology, 2 Biomedical Statistics and Informatics, and 3 Dermatology, Mayo Clinic, Rochester, MN. Key Words: Skin biopsy requisition form; Requisition form; Dermatopathology; Utilization Am J Clin Pathol December 2016;146: DOI: /AJCP/AQW186 CME/SAM ABSTRACT Objectives: To define indices of completeness and accuracy of clinical information in the skin biopsy requisition form (RF) and correlate them with health care delivery outcomes and pathology service utilization. Methods: RFs in our pathology information system were reviewed and assessed for the presence of 10 clinical elements considered critical for dermatopathologic diagnosis. Accuracy was determined by reviewing corresponding clinical notes. Results: In total, 249 RFs were reviewed. In inflammatory dermatoses, provision of a clinical impression, provision of more than two elements, and achieving more than 75% accuracy were associated with improved outcomes and decreased utilization. For all nonlymphoproliferative cases, higher quality clinical information was associated with decreased turnaround time ( P <.001). More clinical information was associated with increased utilization and turnaround time ( P ¼.0235) for lymphoproliferative cases and higher resampling rates for melanocytic lesions ( P ¼.0066). Conclusions: In inflammatory dermatoses, providing highquality clinical information on the RF promotes optimal histopathologic diagnostic performance and appropriate pathology service utilization. Upon completion of this activity you will be able to: list clinical information that is critical for accurate and timely dermatopathologic interpretation. discuss barriers to the provision of relevant clinical information in the skin biopsy requisition form. describe the potential effects of communication failures in the skin biopsy care process on pathology service utilization and health care delivery outcomes. The ASCP is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The ASCP designates this journal-based CME activity for a maximum of 1 AMA PRA Category 1 Credit TM per article. Physicians should claim only the credit commensurate with the extent of their participation in the activity. This activity qualifies as an American Board of Pathology Maintenance of Certification Part II Self-Assessment Module. The authors of this article and the planning committee members and staff have no relevant financial relationships with commercial interests to disclose. Exam is located at The skin biopsy requisition form (RF) is an essential communication tool in the skin pathology care coordination cycle that frequently lacks relevant clinical information, resulting in adverse consequences for diagnostic performance, workflow efficiency, and pathologist dissatisfaction. 1 The skin biopsy care coordination cycle in dermatopathology practice is a closed loop, beginning with the procurement of a skin biopsy specimen during the clinical encounter, submission of the clinical specimen along with pertinent clinical information to the pathologist for interpretation, and communication of the final pathologic diagnosis to the clinician and patient to guide further medical decision making and management Figure 1. Multiple handoffs occur during the cycle between the clinician and patient, the clinician and the pathologist, and the American Society for Clinical Pathology, All rights reserved. Downloaded For from permissions, please journals.permissions@oup.com on 14 February Am J Clin Pathol 2016;146:

2 Romano et al /SKIN BIOPSY REQUISITION FORMS 2,135 Melanocytic, 1,406 inflammatory, 5,353 nonmelanocytic, and 172 lymphoproliferative cases; each category interrogated sequentially to identify cases for analysis 40 Inflammatory, 69 melanocytic, 71 nonmelanocytic, and 25 lymphoproliferative cases analyzed (n = 205) 20 inflammatory and 24 melanocytic cases added using identical search strategy a Second opinion consults, reexcision, rebiopsy, residual or recurrent lesions excluded Subset analysis: 60 inflammatory and 93 melanocytic cases subjected to subset analysis to determine association with outcome variables (n = 153) b 60 Inflammatory, 93 melanocytic, 71 nonmelanocytic, and 25 lymphoproliferative cases evaluated to determine overall composite measures of completeness and accuracy (n = 249) Figure 1 Skin biopsy care process. Reprinted from Comfere NI. Dermatopathologists concerns and challenges with clinical information in the skin biopsy requisition form: a mixedmethods study. J Cutan Pathol. 2015;12: Copyright 2015, John Wiley and Sons, Ltd. Reprinted with permission. pathologist and clinician/patient. Thus, the RF is a vital transition of care document. Effective communication and handoffs are components of medical practice that not only have a direct impact on the quality and safety of patient care but also constitute core competencies of the Accreditation Council for Graduate Medical Education common program requirements and quality metrics that are monitored by The Joint Commission. 2,3 Therefore, failure to optimize communication and handoffs in the skin biopsy care process has significant implications for the quality and safety of patient care. A survey of the membership of the American Society of Dermatopathology (ASDP) 1 identified frequent failures of communication in the skin biopsy care process reflected by missing or inaccurate clinical information in the RF and suggested several critical clinical elements that should be present in the RF for broad disease categories. 1 While multiple studies have demonstrated the deficiencies associated with the completeness of clinical information in the RF and potential impact on outcomes, to our knowledge, there has not been a systematic effort to define standard indices for the quality of communication in the skin biopsy care process, such as measures of completeness and accuracy of clinical information in the RF. In this study, our primary objective was to define indices for the completeness and accuracy of clinical information in the RF and to correlate these indices with key pathology service outcomes, including time to diagnosis, additional histopathologic stains and sections, and a key health care delivery outcome specifically, the rate of Figure 2 Schematic of search strategy and study design. Melanocytic included benign and malignant melanocyctic proliferations; inflammatory included psoriasis, dermatitis, drug reaction, and so on; nonmelanocytic included benign and malignant epithelial proliferations; lymphoproliferative included lymphoma, mycosis fungoides, and so on. a Additional cases included to improve statistical power for analysis. b The same 60 inflammatory cases and 93 melanocytic cases evaluated in the subset analysis were included in the comprehensive determination of measures of completeness and accuracy. reexcision or rebiopsy to inform future recommendations guiding the provision of clinical information on the RF. Materials and Methods Case Selection Following approval for this study from the Mayo Clinic Institutional Review Board, a retrospective cohort analysis of RFs at Mayo Clinic Rochester was conducted for cases accessioned from January 1, 2008, to October 31, Cases were identified by conducting a search of the CoPath (Cerner Corporation, Kansas City, MO) database for each of four distinct categories of cases: (1) melanocytic, (2) inflammatory, (3) nonmelanocytic (benign and malignant epithelial, nonepithelial/mesenchymal-based proliferations), and (4) lymphoma/lymphoproliferative disorders (LPDs). Figure 2 is a schematic of our method. Melanocytic cases were identified using the search terms nevus, lentigo, and melanoma. Inflammatory cases were identified using the search terms inflammation, psoriasis, dermatitis, lichen planus, erythema multiforme, dermatitis 728 Am J Clin Pathol 2016;146: American Society for Clinical Pathology 728 Downloaded from

3 herpetiformes, graft vs host disease, drug, granuloma, granulomatous, folliculitis, dermatosis, and urticaria. Nonmelanocytic cases were identified using the search terms cyst, carcinoma, keratosis, metastasis, metastatic, adenoma, fibroma, cicatrix, and scar. LPD cases were identified using the search terms lymphoma, lymphomatoid, mycosis fungoides, leukemia, and lymphoid. The search result categories were then interrogated sequentially to identify cases for analysis. Only initial sampling of skin specimens submitted for primary diagnosis were included. No second opinion consultation cases, reexcisions, rebiopsy specimens, or residual or recurrent lesions were included. We sought a minimum of 25 cases per category and a roughly equivalent distribution of internal (skin biopsy specimens generated within our institution) and external (skin biopsy specimens generated outside our institution and submitted to our institution for interpretation) cases. The final number of cases per category was not equal across all categories but rather was reflective of the natural distribution of cases across our practice. An initial total of 205 cases were evaluated: 110 internal cases in which the RF had an accompanying encounter visit note (EVN) in the electronic health record (EHR) and 95 external cases for which there was no accompanying EVN. The composition of these 205 cases included 40 inflammatory lesions, 69 melanocytic lesions, 71 epithelial (nonmelanocytic) lesions, and 25 lymphoproliferative disorders. Initial analysis identified significant associations with outcomes for the inflammatory and melanocytic categories, and thus an additional 20 inflammatory (for a total of 60) and 24 melanocytic (for a total of 93) cases were added to improve the statistical power for analysis. Composite measures of completeness and accuracy were determined on the total number of cases (N¼ 249). However, statistical analysis to determine the correlation between indices and outcomes was carried out only on the initial group of 205 cases and in the subset analysis of the 60 inflammatory and 93 melanocytic cases. Assessment of Index for Completeness of Clinical Information Completeness was assessed based on the presence or absence of 10 critical clinical elements necessary for pathologic interpretation as established in the survey of ASDP dermatopathologists Table 1. 1 Melanocytic lesions were assessed using all 10 clinical elements (including ABCDE criteria: asymmetry, border irregularity, color variation, diameter >6 mm, evolving or changing features) while cases in the remaining three categories were assessed using nine clinical elements (ABCDE criteria were not applicable). The presence or absence of each of the 10 clinical elements was assessed as 1 ¼ present or 0 ¼ absent, so that a summated score, Table 1 Variables for Missing Clinical Information and Data Accuracy Indices Key Independent Variables Patient age Prior dermatopathologic diagnosis Anatomic location of biopsy Duration of lesion(s) Partial vs complete sampling Pertinent clinical diagnoses Clinical impression ABCDE criteria Morphologic description Clinical photographs Key Dependent Variables Time to diagnosis Surgical reexcision rate Rebiopsy rate Rates of additional pathology stains Rates of additional tissue sections ABCDE, asymmetry, border irregularity, color variation, diameter >6 mm, evolving or changing features. ranging from 0 to 10, directly interpretable as the number of clinical elements present on the RF was assigned (the index on a scale of 10). If any items were not applicable for a case, the summated score was rescaled so that 10 was the maximum possible score. For example, if only eight items were applicable for a case, the sum of the scores was multiplied by 1.25 (10/8). For clinical impression, a specific clinical diagnosis was required to be listed to be considered present. For example, the term nevus was considered sufficient for clinical impression, while the terms benign and neoplasm were considered insufficient, and the clinical impression was thus scored as absent in such cases. ABCDE criteria were considered present for melanocytic lesions if at least one of the five criteria (asymmetry, irregular borders, color, diameter, evolving) were present. If none of the five were listed, this was scored as absent. Clinical photographs was scored as present if any information was listed in the RF informing the pathologist that photographs had been obtained during the related clinic encounter, regardless of whether there was specific documentation stating that the photographs were made available to the pathologist. Assessment of Index for Accuracy of Clinical Information For each case in which an RF had a corresponding EVN, the EVN was reviewed to assess for accuracy of each critical clinical element (1 ¼ accurate, 0 ¼ not accurate). The clinical information contained in the EVN served as the reference standard for assessment of clinical element accuracy. For each case, accuracy of each variable was recorded, and the same inclusion criteria for each category were applied as listed above. Clinical element accuracy was assessed only for cases in which the element was present in the RF and scored to create an index scaled out of a total score of 10 (eg, if three elements were present in the RF and only two of these elements were accurate in the EVN, the American Society for Clinical Pathology Am J Clin Pathol 2016;146: Downloaded 729 from

4 Romano et al /SKIN BIOPSY REQUISITION FORMS accuracy score was reported as 6.6 on a scale of 10, the equivalent of two-thirds or 66%). If the element was absent from the RF, the clinical information in the EVN corresponding to that element was considered not applicable and not counted toward the total score. Instances in which an element was listed in the RF but the corresponding information in the EVN specific to that element was either absent or different from that listed in the RF were considered inaccurate, scored as 0, and factored into the total score. Assessment of Key Outcomes The key outcome variables in our analysis included time to diagnosis, rate of rebiopsy, rate of reexcision, rate of additional tissue sections, and rate of additional immunohistochemical or special stains. Time to diagnosis was defined as the time period between final electronic verification of slides by the histology laboratory (signifies that slides are ready for delivery to the pathologist) and electronic signature of the final pathology report. Time to diagnosis was determined in hours from the time the first set of slides for each case was initially made available to the pathologist until the report was signed. To account for idle time after hours, on weekends, and on holidays and to correct for cases whose turnaround time may have been falsely prolonged due to an extended holiday weekend, for example, only normal business hours (8:00 AM to 5:00 PM, Monday through Friday) were counted toward the total number of hours required to finalize a case and sign the report. Rebiopsy or reexcision events were defined as rebiopsies or reexcisions occurring at the primary cutaneous site within 6 months of the index biopsy as determined by review of the electronic pathology database and the EHR. Additional tissue sections (H&E) were defined as tissue sections beyond the standard two H&E slides that are produced for each case in our routine practice. Additional Variables Additional variables recorded included patient sex, type of specimen (punch biopsy, shave biopsy, excision), signing pathologist, specialty of ordering provider (dermatologist vs nondermatologist), training status of ordering provider (resident/fellow vs staff physician, with mid-level providers, such as physician assistants and certified nurse practitioners, included with trainees), stage of disease for applicable neoplasms, and facility source of material. Statistical Analysis This study used descriptive summary measures of means and standard deviations for continuous variables and percentages for nominal variables. For continuous outcomes (eg, number of elements present, number of elements accurate), differences between groups were tested using nonparametric Wilcoxon tests. For binary outcomes (eg, repeat excision, >2 days to diagnosis), differences between groups were tested using v 2 tests. All tests were two-sided with 5% type I error rates. All analyses were run using SAS version 9.4 (SAS Institute, Cary, NC). Results In total, 249 RFs were retrieved, representing the following distribution: 60 (24%) inflammatory dermatoses, 93 (37%) melanocytic lesions, 71 (29%) nonmelanocytic (epithelial and mesenchymal) lesions, and 25 (10%) lymphoproliferative lesions. A total of 132 (53%) cases were internal, with corresponding clinical EVNs that allowed determination of information accuracy relative to that listed on the RF, while 117 (47%) cases were external, for which the RF was the only source of clinical information. Mean age of patients was 58.8 years (range, 4-94 years). In total, 127 (51%) patients were women, while 122 (49%) patients were men. Figure 3 shows the percentage of cases in which each clinical element was provided on the RF for all 249 cases, both internal and external. Figure 4 demonstrates the percentage of cases in which each clinical element was provided in both the RF and clinical EVN for the internal cases. Table 2 represents the initial analysis of 205 cases and demonstrates the mean indices of completeness and accuracy relative to diagnostic turnaround time, the need for reexcision, and pathology service utilization. Observations within the inflammatory and melanocytic cohorts during this initial analysis prompted the subset analyses for these two groups. The subset analysis of inflammatory lesions showed that the provision of more clinical elements on the RF was associated with fewer requests for additional stains, additional sections, and improved turnaround times. This inflammatory subset analysis identified critical thresholds for completeness (more than two elements present) and accuracy (>7.5 or 75% accuracy), as well as the critical importance of a documented clinical impression. Cases in which these thresholds were exceeded, particularly those in which a clinical impression was provided, were associated with optimal outcomes. Table 3 shows the relationship between completeness and accuracy of clinical elements and outcomes for the inflammatory subset, including a comparison based on the critical thresholds and the provision and accuracy of a clinical impression. In the melanocytic subset, a higher frequency of reexcisions was observed when more clinical elements were provided on the RF. On average, melanocytic lesions that underwent reexcision had 3.1 elements present compared with 2.7 elements present (P ¼.0066) for cases that were not reexcised. When more than two elements were present, 730 Am J Clin Pathol 2016;146: American Society for Clinical Pathology 730 Downloaded from

5 Percent of Cases Age Location Clinical Impression Lesion Morphology Prior Clinical Diagnosis ABCDE Prior Skin Biopsy Figure % of melanocytic lesions were reexcised compared with a reexcision rate of 4% when two or fewer elements were listed on the RF (data not shown). Table 4 shows completeness and accuracy measures for the initial cohort of 205 cases. It demonstrates the differences in provision of clinical information between dermatologists and nondermatologists for lymphoproliferative and nonlymphoproliferative cases, as well as correlates these differences with diagnostic turnaround time. Table 5 provides a comparison of internal and external cases in the initial cohort of 205 cases. Discussion Diagnosis Lesion Duration Partial/Complete Sampling Photographs Completeness of clinical information on the skin biopsy requisition form across all cases, internal and external (n ¼ 249). Each bar represents the percentage of cases in which the specified clinical element was provided on the requisition form. Percent of Cases Age Clinical Impression Lesion Location Prior Skin Biopsy Diagnosis Lesion Duration Prior Clinical Morphology Diagnosis ABCDE EVN SBRF Photographs Partial/Complete Sampling Figure 4 Comparison of the completeness of clinical information listed in the encounter visit note relative to the skin biopsy requisition form for all internal cases (n ¼ 132). Each bar represents the percentage of cases in which the specified clinical element was provided in the clinical encounter visit note and the corresponding requisition form. Literature has established the importance of accurate and specific clinical information to accurate histopathologic Table 2 Analysis of Initial Cohort (n ¼ 205): Indices of Completeness and Accuracy Relative to Diagnostic Turnaround Time, Surgical Reexcision, and Pathology Service Utilization a Characteristic P Value Time to diagnosis 2d >2d Completeness 2.9 (0.6) 3.1 (0.9).2758 Accuracy 9.1 (1.8) 9.2 (1.7).7013 Reexcision b No Yes Completeness 3.0 (0.8) 3.1 (0.6).2384 Accuracy 9.3 (1.5) 9.1 (1.4).5187 Additional stains No Yes Completeness 3.0 (0.6) 3.1 (1.0).3795 Accuracy 9.2 (1.6) 9.1 (1.9).8940 Additional sections No Yes Completeness 3.0 (0.6) 3.1 (0.9).5651 Accuracy 9.2 (1.6) 9.1 (1.9).6706 a As outlined in the Materials and Methods section, the number listed for completeness is the mean (SD) number of elements listed on the RF per case. The number listed for accuracy is the scaled score (SD) out of 10, reflective of the percentage of elements listed on the RF that were accurate relative to that element s depiction in the corresponding encounter visit note, which served as the reference standard. b In all cases requiring resampling of a lesion, the repeat sampling was performed using surgical reexcision. No resampling by repeat biopsy was observed. diagnosis in pathology, as well as frequent deficiencies in the provision of relevant clinical information on the RF. These deficiencies result in adverse effects on health care delivery outcomes, unnecessary health care utilization, waste, and added costs. 4-9 Barriers to providing this information in practice include increasing patient volumes, time constraints, lack of familiarity with specialty-specific terminology, lack of standardization or consensus as to what constitutes relevant clinical information, and the openended nature of many requisition forms, which lack prompts for specific information, leading numerous authors to suggest new RF designs. 4,5,10,11 Other barriers cited include lack of written standard operating procedures outlining proper provision of information on the RF or proper acquisition, storage and transmittance of clinical photographs, and cost implications and training requirements for clinical photograph standardization across a practice, despite the universally accepted value of a clinical photograph to the pathologist. 12 These barriers are further exacerbated by an existing belief among clinicians that pathology interpretation should not be biased by exposure to clinical information as highlighted in the results of a survey of dermatologists where one-third of respondents agreed at least somewhat with statements that dermatopathologists should be able to make a diagnosis without clinical information or that they might be biased by clinical information on the RF. 13 Our study results, however, serve to highlight the adverse impact that insufficient clinical information in the RF may have on pathology service and health care delivery outcomes in dermatopathology for inflammatory diagnoses. While numerous authors have published suggested American Society for Clinical Pathology Am J Clin Pathol 2016;146: Downloaded 731 from

6 Romano et al /SKIN BIOPSY REQUISITION FORMS Table 3 Subgroup Analysis for Inflammatory Group: Overall Completeness and Accuracy of Critical Clinical Elements, Presence and Accuracy of Clinical Impression, and Impact on Pathology Service Utilization and Diagnostic Turnaround Times (n ¼ 60) a Characteristic No (n ¼ 31) Additional Stains Additional Tissue Sections Time to Diagnosis Yes (n ¼ 29) P Value No (n ¼ 41) Yes (n ¼ 19) P Value 2 Days (n ¼ 30) >2 Days (n ¼ 30) P Value Completeness index b >2(n¼44; 73%) 28 (63) 16 (36) (77) 10 (23) (64) 16 (36).0005 Completeness index b 2(n¼16; 27%) 3 (19) 13 (81) 7 (44) 9 (56) 2 (13) 14 (87) Clinical impression present (n ¼ 43; 72%) 28 (65) 15 (35) (77) 10 (23) (65) 15 (35).0002 Clinical impression absent (n ¼ 17; 28%) 3 (18) 14 (82) 8 (47) 9 (53) 2 (12) 15 (88) Accuracy index c >7.5 (n ¼ 28; 47%) 19 (68) 9 (32) (82) 5 (18) (68) 9 (32).009 Accuracy index c 7.5 (n ¼ 32; 56%) 12 (38) 20 (63) 18 (56) 14 (44) 11 (34) 21 (66) Clinical impression accurate (n ¼ 32; 91%) 22 (69) 10 (31) (84) 5 (16) (69) 10 (31).94 Clinical impression inaccurate (n ¼ 3; 9%) 1 (33) 2 (67) 1 (33) 2 (67) 2 (67) 1 (33) Mean number of elements present on the RF RF, requisition form. a Values are presented as number (%) unless otherwise indicated. b Completeness index: summated score of the number of elements present on the requisition form (RF) (out of a total possible score of 10). c Accuracy index: scaled score (out of a total possible score of 10) reflecting accurate or matching clinical elements in the encounter visit note (EVN) relative to the information for those elements listed on the RF. Accuracy of the information in the EVN was determined only for those elements listed on the RF for each case. Table 4 Indices of Completeness and Accuracy of Clinical Information: Comparison Between Dermatologists and Nondermatologists Relative to LPD vs Non-LPD Cases and the Impact on Time to Diagnosis a Outcomes Dermatologist LPD Cases Dermatologist Non-LPD Cases Nondermatologist LPD Cases Nondermatologist Non-LPD Cases >2 days to diagnosis, % of cases <.001 Elements present 3.6 (1.3) 3.1 (0.5) 2.1 (0.4) 2.5 (0.8) <.001 Elements accurate 9.5 (1.7) 9.1 (1.8) 9.3 (1.9) 9.2 (1.4).53 Elements present and accurate 3.4 (1.3) 2.8 (0.8) 2.0 (0.6) 2.4 (0.7) <.001 LPD, lymphoproliferative disorder. a Values are presented as mean (SD) unless otherwise indicated. Non-LPD cases include all inflammatory, melanocytic, and epithelial (nonmelanocytic) cases evaluated. LPD cases are those in which the final diagnosis included any one of the following terms: lymphoma, lymphomatoid, mycosis fungoides, leukemia,orlymphoid. P Value Table 5 Comparison of Internal and External Cases: Effect of Completeness of Information on Outcomes (n ¼ 205) a Characteristic Critical elements present Days from slides verified to report signed Repeat excision, No. (%) Additional stains, No. (%) No. of additional stains per case Additional sections, No. (%) No. of additional sections per case Internal Cases b (n ¼ 110) External Cases (n ¼ 95) P Value 3.1 (0.9) 2.9 (0.6) (5.7) 3.4 (2.4) (19.3) 10 (10.5) (48.2) 22 (23.2) (4.9) 0.3 (0.7) < (41.8) 27 (28.4) (2.4) 0.6 (1.3).0223 a Values are presented as mean (SD) unless otherwise indicated. b Internal cases include 25 (23%) lymphoproliferative disorder (LPD) cases, while no LPD cases are included in the cohort of external cases. guidelines for optimal RF completion, 7,14,15 compliance with these guidelines, their implementation, and the attendant potential adverse consequences of noncompliance have not been fully elucidated. Even though the relevance of anatomic location, an element almost universally provided on the RF by practitioners, has been challenged, 16 our experience suggests that items such as patient demographics and anatomic location are critical clinical elements to consider when rendering a diagnosis in dermatopathology. Our primary objective was to define measures of completeness and accuracy of clinical information for the RF and then to assess the impact of those measures on pathology service and health care delivery outcomes. Congruent with our study hypothesis, higher measures of completeness and accuracy of clinical information on the RF were associated with improved pathology service and health care delivery outcomes that is, faster diagnostic turnaround times, fewer additional tissue sections, fewer special and immunohistochemical stains, and lower rates of rebiopsy or reexcision in 732 Am J Clin Pathol 2016;146: American Society for Clinical Pathology 732 Downloaded from

7 the inflammatory cohort. Our subgroup analyses proved more capable of detecting meaningful associations, whereas the initial comprehensive analysis, devoid of data set partitioning (as shown in Table 2), showed no significant correlations. Contrary to our study hypothesis and to the findings noted with the inflammatory cohort, more elements of clinical information on the RF were associated with longer turnaround times, a higher frequency of additional stains and sections, and higher mean numbers of additional stains and sections per case across the entire cohort when direct comparison between internal and external cases was undertaken, as shown in Table 5. A substantial contribution to these findings appears to be secondary to the inclusion of lymphoproliferative cases, which accounted for 23% of our internal cases in the initial analysis of 205 cases and inherently tend to require more sophisticated workups. We would speculate that more clinical information supplied on the RF may have facilitated the pursuance of additional evaluation to ensure optimal diagnostic interpretation, irrespective of the inherent complexity of LPD cases. In melanocytic cases, higher rates of reexcision were associated with the provision of more information, largely due to the provision of a clinical impression. In these cases that underwent reexcision, either the clinical impression or the pathologic diagnosis (sometimes both) for the index biopsy included terms that conveyed a malignant disposition such as melanoma or atypia, or involving biopsy borders. Thus, while reexcision may have been clinically indicated for some of these cases simply due to positive margins, the clinical impression and final pathologic diagnosis often seemed to work in concert to promote reexcision, possibly by conveying heightened concern for aggressive behavior based on clinical features, histopathologic features, or both. Our study was not designed to account for other patient- and clinicianrelated factors that are considered in the decision to reexcise a pigmented lesion. We observed the greatest impact of missing or inaccurate information on pathology service utilization within the inflammatory dermatoses cohort and found that clinical impression is the most critical of all clinical elements. Having more than two elements present and more than 75% accuracy emerged in our study as the critical thresholds for clinical information to result in improved pathology service and health care delivery outcomes for inflammatory dermatoses. Indeed, this cut point of two elements being present reflects the near-universal provision of age and anatomic location among providers. However, among all of the remaining elements, only the presence and accuracy of clinical impression proved to have a statistically significant effect on outcomes for inflammatory lesions. This is an important finding given that clinical impression is also the most commonly provided element after age and anatomic location, although Sellheyer and Bergfeld 7 aptly point out that clinical impression alone may not be sufficient in inflammatory lesions. Although we only addressed accuracy of the clinical impression as it related to whether a matching clinical impression was listed in the EVN (rather than assess its diagnostic accuracy), the diagnostic accuracy of a clinical impression is still of utmost importance, since Cerroni et al 17 showed that in each inflammatory skin case in which all pathologists (nine observers) reached the wrong histopathologic diagnosis, the diagnostic accuracy of the clinical impression was wrong as well. Diagnostic accuracy is perhaps the most critical health care delivery outcome in the pathology setting, with a correct histopathologic diagnosis forming the basis for distant health care delivery outcomes, such as treatment choice, and overall clinical outcomes, such as disease recurrence and survival. However, our current study was focused on the provision of information on the RF and in the EVN, as well as the effects of incomplete or inaccurate information on pathology service delivery and the proximal health care delivery outcome of resampling rates. Numerous authors have previously substantiated the critical importance of the clinician providing a specific clinical impression on the RF in cases of inflammatory processes. Rajaratnam et al 18 reported that in 25% of inflammatory dermatoses, an accurate diagnosis was reached only after clinical data were made available to the observer. Similarly, Aslan and colleagues 16 showed a significant decrease in the rate of clinicopathologic consistency for inflammatory dermatoses and an increase in the number of pathologic differential diagnoses suggested in the absence of clinical information. These findings underscore the tenet that both pathologic diagnostic accuracy and pathologic diagnostic specificity require an in-depth understanding of the clinical context and presentation, in addition to a well-developed clinical impression or differential diagnosis. 18 Perhaps the most intriguing finding in our study was the relative paucity of information provided on the RF and the paucity of significant associations between the clinical information on the RF and outcomes, despite published assertions regarding the importance of providing certain information, including, for example, mention of partial sampling, ABCDE criteria for melanocytic lesions, and availability of clinical photographs. 4,17 This could be explained by the limited nature of data restricted to the experience of a single tertiary care institution or the small sample size of our cohort relative to the number of dermatopathology specimens received at our institution. However, the lack of associations identified in our study may indicate that some of these clinical elements, perceived as critical for pathologic interpretation by survey American Society for Clinical Pathology Am J Clin Pathol 2016;146: Downloaded 733 from

8 Romano et al /SKIN BIOPSY REQUISITION FORMS respondents, may rather be of variable utility depending on the pathologist s experience and the clinical question to be addressed. A secondary goal of our study was to compare provision of information and subsequent outcomes between dermatologists and nondermatologists and between practicing physicians and trainees or mid-level providers. Sellheyer and Bergfeld 6,7 showed significantly better performance by dermatologists in providing clinical information relative to family practitioners, and our results confirm this phenomenon. However, we saw no statistically significant differences in the amount of information provided between staff physicians and either trainees (residents and fellows) or mid-level providers and thus no effect on outcomes. This is in agreement with the observations of Waller and Zedek, 4 although interestingly, Morton and Mackie 19 showed that staff dermatologists, compared with trainees, demonstrated better clinical diagnostic accuracy and lower biopsy rates. Our study findings failed to resolve noted discrepancies in clinical information between the RF and the EVN, which in many cases, just as with errors in specimen labeling or handling, can be attributed to human factors. 20 Current practice requires a duplication of effort in entering information, once in the EVN and again on the RF, a practice that is both error prone and serves as a disincentive for the ordering provider, as outlined by Olson and colleagues. 21 Their study, which to our knowledge is the first to address this issue in dermatopathology practice, showed frequent discrepancies between the RF and the EVN, as well as highlighted a lack of standardization of clinical content among clinicians drafting the EVN, noting critical clinical element omissions and variable placement of elements under different subsections in the EVN. 21 Thus, access to a shared EHR by the pathologist, which may be assumed to give the pathologist an advantage in reviewing internal cases relative to external or consultation cases with limited or absent clinical information, may be insufficient for optimal diagnostic efficiency or improved outcomes as measured in this study. As noted by Comfere and colleagues 1 and Olson et al, 21 and again confirmed in our study, there is substantially more useful information in the EVN, but the templated nature of many current EHRs has had the unintended consequence of replacing a descriptive narrative, which, in the absence of a clinical photograph, is often the most helpful element for dermatopathologic diagnosis. Further investigations of customized user interfaces that rely on data-mining strategies to search for, retrieve, and present clinical information necessary for dermatopathologic interpretation to the pathologist at the point of care are needed. We are aware of limitations encountered in the design and analysis stages of this study. For the external cases, only the information present on the RF was available for review at the time of the study. This does not take into account any information that may have been conveyed in a consultation letter, in other correspondence, or through verbal discussion (eg, by telephone) of case details between the provider who performed the biopsy and the signing pathologist. In addition, our internal cases reflect the unique practice setting of our tertiary care center, in that the signing pathologist still has access to these critical clinical elements by way of the EVN and clinical photographs contained in our institution s EHR. This workaround allows the pathologist to mitigate some of the effects of incomplete information on the RF for internal cases, although we recognize that factors other than completeness and accuracy of clinical information may influence a clinician s decision to perform a rebiopsy or reexcision and a pathologist s decision to order additional tissue sections or stains. The retrospective nature of the study prohibited evaluation of the manner in which the signing pathologist may (or may not) have used additional information in the EHR. Selection bias also remains a limitation of our study, given that we assessed only a sample of our larger case population. Last, the time to diagnosis relied on electronic checkpoints from the time slides were electronically verified in the histology laboratory (and shortly thereafter delivered to the pathologist) to the time of electronic signature of the final report. We encountered isolated inconsistencies in the timing of slide verification and thus possible inconsistencies in our recorded turnaround times. For these reasons, future prospective controlled studies that correct for potential confounders would be ideal. Conclusions Our study has demonstrated that overall, dermatologists provide higher quality clinical information on the RF relative to other clinicians and that the RF is underused as a transition of care document. The notion that the RF represents a patient handoff seems to have been lost on both clinicians and pathologists. Clear communication between the clinician and the pathologist and the mere provision of clinical information appear to be more important than the accuracy of the information provided in our unique practice setting, where easy access to the EVN may supersede the RF as a data source. Pathologists, responsible for this phase of patient care, which forms the basis of subsequent treatment and management decisions, should be vigilant in seeking as much information as needed to render a diagnosis with the highest possible confidence. An integrated EHR, access to clinical photographs, and the availability of clinical notes serve as valuable resources for clinical information, particularly when information is limited or absent on the RF, and in some instances may actually supplant the RF, thus 734 Am J Clin Pathol 2016;146: American Society for Clinical Pathology 734 Downloaded from

9 calling into question the utility of the RF as anything other than a duplicate document listing patient and specimen identity in its current form. Future studies should focus on optimizing and validating the RF and innovative EHR user interfaces, for the benefit of ordering providers, pathologists, the health care system, and, most important, patients. Corresponding author: Nneka I. Comfere, MD, Depts of Dermatology and Laboratory Medicine and Pathology, Mayo Clinic, 200 First St SW, Rochester, MN 55905; comfere.nneka@mayo.edu. References 1. Comfere NI, Peters MS, Jenkins S, et al. Dermatopathologists concerns and challenges with clinical information in the skin biopsy requisition form: a mixedmethods study. J Cutan Pathol. 2015;42: DeRienzo CM, Frush K, Barfield ME, et al. Handoffs in the era of duty hours reform: a focused review and strategy to address changes in the accreditation council for graduate medical education common program requirements. Acad Med. 2012;87: The Joint Commission. Hand-off communications. aspx?project¼1. Accessed April 17, Waller JM, Zedek DC. How informative are dermatopathology requisition forms completed by dermatologists? A review of the clinical information provided for 100 consecutive melanocytic lesions. J Am Acad Dermatol. 2010;62: Comfere NI, Sokumbi O, Montori VM, et al. Provider-toprovider communication in dermatology and implications of missing clinical information in skin biopsy requisition forms: a systematic review. Int J Dermatol. 2014;53: Sellheyer K, Bergfeld WF. A retrospective biopsy study of the clinical diagnostic accuracy of common skin diseases by different specialties compared with dermatology. J Am Acad Dermatol. 2005;52: Sellheyer K, Bergfeld WF. Lesion, rule out..., and other vagaries of filling out pathology requisition forms. J Am Acad Dermatol. 2005;52: Massone C, Soyer HP, Lozzi GP, et al. Feasibility and diagnostic agreement in teledermatopathology using a virtual slide system. Hum Pathol. 2007;38: Ferrara G, Argenyi Z, Argenziano G, et al. The influence of clinical information in the histopathologic diagnosis of melanocytic skin neoplasms. PLoS One. 2009;4:e Mohr MR, Indika SH, Hood AF. The utility of clinical photographs in dermatopathologic diagnosis: a survey study. Arch Dermatol. 2010;146: Cox NH, Wagstaff R, Popple AW. Using clinicopathological analysis of general practitioner skin surgery to determine educational requirements and guidelines. BMJ. 1992;304: Vivas A, Kirsner RS. Submitting clinical photographs to dermatopathologists to facilitate interpretations. Arch Dermatol. 2010;146: Chismar LA, Umanoff N, Murphy B, et al. The dermatopathology requisition form: attitudes and practices of dermatologists. J Am Acad Dermatol. 2015;72: Boyd AS, Neldner KH. How to submit a specimen for cutaneous pathology analysis: using the 5 Ds to get the most from biopsies. Arch Fam Med. 1997;6: O Connor KM, Chien AJ. Management of melanocytic lesions in the primary care setting. Mayo Clin Proc. 2008;83: Aslan C, Goktay F, Mansur AT, et al. Clinicopathological consistency in skin disorders: a retrospective study of 3949 pathological reports. J Am Acad Dermatol. 2012;66: Cerroni L, Argenyi Z, Cerio R, et al. Influence of evaluation of clinical pictures on the histopathologic diagnosis of inflammatory skin disorders. J Am Acad Dermatol. 2010;63: Rajaratnam R, Smith AG, Biswas A, et al. The value of skin biopsy in inflammatory dermatoses. Am J Dermatopathol. 2009;31: Morton CA, Mackie RM. Clinical accuracy of the diagnosis of cutaneous malignant melanoma. Br J Dermatol. 1998;138: Kim JK, Dotson B, Thomas S, et al. Standardized patient identification and specimen labeling: a retrospective analysis on improving patient safety. J Am Acad Dermatol. 2013;68: Olson MA, Lohse CM, Comfere NI. Rates of provision of critical clinical information in the requisition form and encounter visit note. Poster session presented at the American Society of Dermatopathology 51st Annual Meeting; November 7, 2014; Chicago, IL. American Society for Clinical Pathology Am J Clin Pathol 2016;146: Downloaded 735 from