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The College of American Pathologists (CAP) offers a suite of laboratory accreditation programs, including one specific to accreditation to the international organization for standardization (ISO) 15189 standard for quality management specific to medical laboratories. CAP leaders offer an overview of ISO 15189 including its components, internal audits, occurrence management, document control, and risk management. The authors provide a comparison of its own ISO 15189 program, CAP 15189, to the CAP Laboratory Accreditation Program. The authors conclude with why laboratories should use ISO 15189.

The advent of fiberoptic endoscopy with biopsy has revolutionized procurement of specimens from deep sites. This has translated into more cytologic specimens whereby the material is limited and best handled by cytology laboratory staff. While the diagnosis of the pathologic process is of utmost importance, there is increasing expectation that the diagnosis be specific and accurate as not to require additional biopsy for initiation of treatment. This expectation has driven demand in immunohistochemical (IHC) and molecular studies conducted specifically on material processed as cytology specimens. The Clinical Laboratory Improvement Amendments of 1988 requires laboratories in the United States of America to verify the performance of patient tests. Due to varying laboratory practices with respect to validation of IHC assays, the College of American Pathologists introduced guidelines for analytic validation of IHC tests. These guidelines address how to perform validation by recommending the number of cases in the validation set, comparator concordance, and when to revalidate. The main thrust of the guidelines is based on formalin-fixed paraffin-embedded tissue with only one expert consensus opinion referring to validation of IHC tests on cytology specimens which delegates to the medical director, the determination of number of positive and negative cases to be tested. This article will outline how an academic center approaches validation of IHC studies performed on cytology cell block specimens using the College of American Pathologists guidelines. A stepwise approach from selection of antibodies to validate followed by building the validation panel and evaluating the stain results for concordance against the gold standard of histology tissue specimen will be described. A rationale for dealing with discordant results and future innovations will conclude the report.

Context: The format of a synoptic report can significantly affect the accuracy, speed, and preference with which a reader can retrieve information. Objective: The objective of this study is to compare different formats of Gleason grading/score in synoptic reports of radical prostatectomies. Methods: The performance of 16 nonpathologists (cancer registrars, MDs, medical non-MDs, and nonmedical) at identifying specific information in various formatted synoptic reports using a computerized quiz that measured both accuracy and speed. Results: Compared to the standard format (primary, secondary, tertiary grades, and total score on separate lines), omitting tertiary grade when "Not applicable" reduced accuracy (72 vs. 97%, P < 0.001) and increased time to retrieve information 63% (P < 0.001). No user preferred to have tertiary grade omitted. Both the biopsy format (primary + secondary = total score, tertiary on a separate line) and the single line format (primary + secondary + (tertiary) -> total score) were associated with increased speed of data extraction (18 and 24%, respectively, P < 0.001). The single line format was more accurate (100% vs. 97%, P = 0.02). No user preferred the biopsy format, and only 7/16 users preferred the single line format. Conclusions : Different report formats for Gleason grading significantly affect users speed, accuracy, and preference; users do not always prefer either speed or accuracy.

Context: The College of American Pathologists (CAP) requires synoptic reporting of all tumor excisions. Objective: To compare the performance of different methods of generating synoptic reports. Methods: Completeness, amendment rates, rate of timely ordering of ancillary studies (KRAS in T4/N1 colon carcinoma), and structured data file extraction were compared for four different synoptic report generating methods. Results: Use of the printed tumor protocols directly from the CAP website had the lowest completeness (84%) and highest amendment (1.8%) rates. Reformatting these protocols was associated with higher completeness (94%, P < 0.001) and reduced amendment (1%, P = 0.20) rates. Extraction into a structured data file was successful 93% of the time. Word-based macros improved completeness (98% vs. 94%, P < 0.001) but not amendment rates (1.5%). KRAS was ordered before sign out 89% of the time. In contrast, a web-based product with a reminder flag when items were missing, an embedded flag for data extraction, and a reminder to order KRAS when appropriate resulted in improved completeness (100%, P = 0.005), amendment rates (0.3%, P = 0.03), KRAS ordering before sign out (100%, P = 0.23), and structured data extraction (100%, P < 0.001) without reducing the speed (P = 0.34) or accuracy (P = 1.00) of data extraction by the reader. Conclusion: Completeness, amendment rates, ancillary test ordering rates, and data extraction rates vary significantly with the method used to construct the synoptic report. A web-based method compares favorably with all other methods examined and does not reduce reader usability.