A memorandum of understanding has facilitated guideline development involving collaborating groups.

Objective: Collaboration between groups can facilitate the development of high-quality guidelines. While collaboration is often desirable, misunderstandings can occur. One method to minimize misunderstandings is the pre-specification of terms of engagement in a memorandum of understanding (MOU).

An International Needs Assessment Survey of Guideline Developers Demonstrates Variability in Resources and Challenges to Collaboration between Organizations.

Background: The development of rigorous, high-quality clinical guidelines increases the need for resources and skilled personnel within guideline-producing organizations. While collaboration between organizations provides a unique opportunity to pool resources and save time and effort, the collaboration presents its own unique challenges.

Objective: To assess the perceived needs and current challenges of guideline producers worldwide related to guideline development and collaboration efforts.

Evaluating the Adoption of Laboratory Practice Guidelines.

Context.—: To date, the College of American Pathologists (CAP) has developed 17 laboratory practice guidelines (LPGs) including updates. In 2013, the CAP was awarded a 5-year cooperative agreement grant from the United States Centers for Disease Control and Prevention to increase the effectiveness of LPGs.

Analytic Validation of Immunohistochemical Assays: A Comparison of Laboratory Practices Before and After Introduction of an Evidence-Based Guideline.

Context: - Laboratories must demonstrate analytic validity before any test can be used clinically, but studies have shown inconsistent practices in immunohistochemical assay validation.

Objective: - To assess changes in immunohistochemistry analytic validation practices after publication of an evidence-based laboratory practice guideline.

Design: - A survey on current immunohistochemistry assay validation practices and on the awareness and adoption of a recently published guideline was sent to subscribers enrolled in one of 3 relevant College of American Pathologists proficiency testing programs and to additional nonsubscribing laboratories that perform immunohistochemical testing.

Analytic Validation of Immunohistochemistry Assays: New Benchmark Data From a Survey of 1085 Laboratories.

Context: - A cooperative agreement between the College of American Pathologists (CAP) and the United States Centers for Disease Control and Prevention was undertaken to measure laboratories' awareness and implementation of an evidence-based laboratory practice guideline (LPG) on immunohistochemical (IHC) validation practices published in 2014.

Objective: - To establish new benchmark data on IHC laboratory practices.

Design: - A 2015 survey on IHC assay validation practices was sent to laboratories subscribed to specific CAP proficiency testing programs and to additional nonsubscribing laboratories that perform IHC testing.

Evaluation of Testing of Acute Leukemia Samples: Survey Result From the College of American Pathologists.

Context: - The classification and prognosis determination in acute leukemia (AL) are complex and it is unclear what testing is being performed in practice.

Objective: - To survey physicians describing their current practice of test ordering in the diagnosis of AL.

Design: - In anticipation of a guideline by the College of American Pathologists (CAP) and the American Society for Hematology on laboratory testing needed for the initial workup of AL, a baseline survey was designed by an expert panel from CAP.

Interpretive Diagnostic Error Reduction in Surgical Pathology and Cytology: Guideline From the College of American Pathologists Pathology and Laboratory Quality Center and the Association of Directors of Anatomic and Surgical Pathology.

Context: Additional reviews of diagnostic surgical and cytology cases have been shown to detect diagnostic discrepancies.

Objective: To develop, through a systematic review of the literature, recommendations for the review of pathology cases to detect or prevent interpretive diagnostic errors.

Design: The College of American Pathologists Pathology and Laboratory Quality Center in association with the Association of Directors of Anatomic and Surgical Pathology convened an expert panel to develop an evidence-based guideline to help define the role of case reviews in surgical pathology and cytology.

Principles of analytic validation of immunohistochemical assays: Guideline from the College of American Pathologists Pathology and Laboratory Quality Center.

Context: Laboratories must validate all assays before they can be used to test patient specimens, but currently there are no evidence-based guidelines regarding validation of immunohistochemical assays.

Objective: To develop recommendations for initial analytic validation and revalidation of immunohistochemical assays.

Design: The College of American Pathologists Pathology and Laboratory Quality Center convened a panel of pathologists and histotechnologists with expertise in immunohistochemistry to develop validation recommendations.

Validating whole slide imaging for diagnostic purposes in pathology: guideline from the College of American Pathologists Pathology and Laboratory Quality Center.

Context: There is increasing interest in using whole slide imaging (WSI) for diagnostic purposes (primary and/or consultation). An important consideration is whether WSI can safely replace conventional light microscopy as the method by which pathologists review histologic sections, cytology slides, and/or hematology slides to render diagnoses. Validation of WSI is crucial to ensure that diagnostic performance based on digitized slides is at least equivalent to that of glass slides and light microscopy.

Gynecologic cytology proficiency testing failures: what have we learned?: observations from the college of american pathologists gynecologic cytology proficiency testing program.

Context: In 2006, the first gynecologic cytology proficiency tests were offered by the College of American Pathologists. Four years of data are now available using field-validated slides, including conventional and liquid-based Papanicolaou tests.

Objective: To characterize the pattern of error types that resulted in initial proficiency-test failure for cytotechnologists, primary screening pathologists, and secondary pathologists (those whose slides are prescreened by cytotechnologists).

Consensus statement on effective communication of urgent diagnoses and significant, unexpected diagnoses in surgical pathology and cytopathology from the College of American Pathologists and Association of Directors of Anatomic and Surgical Pathology.

Context: Recognizing the difficulty in applying the concept of critical values to anatomic pathology diagnoses, the College of American Pathologists and the Association of Directors of Anatomic and Surgical Pathology have chosen to reevaluate the concept of critical diagnoses.

Objective: To promote effective communication of urgent and significant, unexpected diagnoses in surgical pathology and cytology.

Design: A comprehensive literature search was conducted and reviewed by an expert panel.

Granulomatous inflammation-an underestimated cause of false-positive diagnoses in lung fine-needle aspirates: observations from the college of american pathologists nongynecologic cytopathology interlaboratory comparison program.

Context: The false-positive rate for fine-needle aspirates of the lung has been cited as less than 1% for granulomatous inflammation, comprising one of the known causes of false-positive diagnoses.

Objective: To determine the rate of false-positive diagnoses of granulomatous inflammation for lung fine-needle aspirates by assessing the false-positive response rate in the context of the College of American Pathologists Nongynecologic Cytopathology Interlaboratory Comparison Program.

Design: We performed a retrospective review of 1092 participant responses for lung fine-needle aspirate challenges with the reference diagnosis of specific infections/granulomatous inflammation from 1998 to 2008 from the College of American Pathologists Nongynecologic Cytopathology Interlaboratory Comparison Program.

Practices of participants in the college of american pathologists interlaboratory comparison program in cervicovaginal cytology, 2006.

Context: Liquid-based preparations (LBPs) and human papillomavirus testing have led to changes in cervical cytology practices. The College of American Pathologists attempts to track practice patterns using a supplemental questionnaire, which allows laboratories to report diagnostic practices.

Objective: To analyze the 2006 reporting practices and to compare the results with the 2003 survey data.

Unsatisfactory reporting rates: 2006 practices of participants in the college of american pathologists interlaboratory comparison program in gynecologic cytology.

Context: -Minimum cellular criteria for satisfactory Papanicolaou tests were established with the Bethesda System in 2001, and unsatisfactory rates are used as a quality-reporting measure.

Objective: -To evaluate practices and unsatisfactory rates from laboratories responding to the 2007 College of American Pathologists supplemental questionnaire survey.

Design: -In 2007, a supplemental questionnaire was mailed to 1621 laboratories enrolled in the 2006 College of American Pathologists Interlaboratory Comparison Program in Gynecologic Cytology (PAP Education), requesting data from the 2006 calendar year.

Automatic failure in gynecologic cytology proficiency testing. Results from the College of American Pathologists proficiency testing program.

Context: Automatic failure in gynecologic cytology proficiency testing occurs when a high-grade lesion or carcinoma (HSIL+, Category D) is misinterpreted as negative for intraepithelial lesion or malignancy (Category B).

Objectives: To document the automatic failure rate in 2006 and 2007 from the College of American Pathologists proficiency testing program (PAP PT) and compare them to projected values from 2004.

Design: Identify automatic failures from PAP PT in 2006 and 2007 and compare the rates of failure regarding participant and preparation type to validated slides in the College of American Pathologists Interlaboratory Comparison Program in 2004.

Guidelines for the reporting of nongynecologic cytopathology specimens.

Context: Gynecologic cytology terminology and report formatting have been nationally standardized since the implementation of The Bethesda System of 1988, but standard reporting for nongynecologic cytology has never been formally addressed on the same scale.

Objectives: To promote patient safety through uniform reporting in nongynecologic cytology (including fine-needle aspiration cytology) and to improve communication between laboratories and health care providers.

Data Sources: Sources include the College of American Pathologists Cytopathology Resource Committee; the College of American Pathologists Council on Scientific Affairs Ad Hoc Committee on Pathology Report Standardization; the College of American Pathologists Laboratory Accreditation Program inspection checklists; the Joint Commission for Accreditation of Healthcare Organizations; and the Clinical Laboratory Improvement Amendments of 1988.

Performance of herpes simplex challenges in proficiency testing: observations from the College of American Pathologists proficiency testing program.

Context: Herpes simplex virus (HSV) is a common sexually transmitted disease that is decreasing in prevalence. Herpes simplex virus challenge cases have performed well in the educational College of American Pathologists Interlaboratory Comparison Program in Cervicovaginal Cytology. However, since gynecologic cytology proficiency testing (PT) was instituted, performance of HSV challenge cases has worsened.

Performance of Candida--fungal-induced atypia and proficiency testing: observations from the College of American Pathologists proficiency testing program.

Context: Candida may elicit cellular changes on otherwise negative screening Papanicolaou tests that may be misinterpreted as atypical squamous cells of undetermined significance. Although these changes have been correctly interpreted in the educational program of the College of American Pathologists, the Interlaboratory Comparison Program in Gynecologic Cytology, the performance of negative slides with Candida faltered when the same field validated slides were included in proficiency testing (PT).

Objective: To identify the performance differences of negative for intraepithelial lesion (NILM) Candida challenges before and after PT.

Appeals in gynecologic cytology proficiency testing: review and analysis of data from the 2006 College of American Pathologists gynecologic cytology proficiency testing program.

Context: In 2006, 9643 participants took the initial College of American Pathologists (CAP) Proficiency Test (PT). Failing participants may appeal results on specific test slides. Appeals are granted if 3 referee pathologists do not unanimously agree on the initial reference diagnosis in a masked review process.

Summary of the 2006 College of American Pathologists Gynecologic Cytology Proficiency Testing Program.

Context: Creating a tool that assesses professional proficiency in gynecologic cytology is challenging. A valid proficiency test (PT) must reflect practice conditions, evaluate locator and interpretive skills, and discriminate between those practitioners who are competent and those who need more education. The College of American Pathologists Gynecologic Cytology Proficiency Testing Program (PAPPT) was approved to enroll participants in a nationwide PT program in 2006.