PCNEO, a New Proficiency Testing Program for Flow Cytometric Analysis of Plasma Cell Neoplasms From the College of American Pathologists Diagnostic Immunology and Flow Cytometry Committee.

Context.—: In 2018 the College of American Pathologists Diagnostic Immunology and Flow Cytometry Committee designed and implemented a new plasma cell neoplasia flow cytometry proficiency testing program-PCNEO-to allow clinical flow cytometry laboratories to monitor and assess their performance compared with a peer group.

Objective.

Reporting and Establishment of Reference Intervals for Antiphospholipid Antibody Immunoassays: A Survey of Participants in the College of American Pathologists Proficiency Testing Program.

Context.—: Misdiagnosis of antiphospholipid syndrome can occur owing to the wide diversity of antiphospholipid (aPL) assays and a lack of international calibrators and harmonized reference intervals.

Objective.

Interlaboratory Agreement of Anti-Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Serologic Assays in the Expedited College of American Pathologists Proficiency Testing Program.

Context.—: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a recently emerged, currently pandemic virus, and the etiologic agent of coronavirus disease 2019 (COVID-19). Clinical testing for antibodies to SARS-CoV-2 has rapidly become widespread, but data regarding the interlaboratory performance of these serologic assays are limited.

Long-Term Variability in Immunofluorescence Titer of Antibodies to Nuclear Antigens Observed in Clinical Laboratory Proficiency Testing Surveys.

Context.—: Presence of antibodies to nuclear antigens (ANAs) above a threshold titer is an important diagnostic feature of several autoimmune diseases, yet titers reported vary between laboratories. Proficiency survey results can help clarify factors contributing to the variability.

Participation in the College of American Pathologists Laboratory Accreditation Program Decreases Variability in B-Lymphoblastic Leukemia and Plasma Cell Myeloma Flow Cytometric Minimal Residual Disease Testing: A Follow-up Survey.

Context.—: Minimal residual disease (MRD) testing by flow cytometry is ubiquitous in hematolymphoid neoplasm monitoring, especially B-lymphoblastic leukemia (B-ALL), for which it provides predictive information and guides management. Major heterogeneity was identified in 2014.

Antinuclear Antibodies Testing Method Variability: A Survey of Participants in the College of American Pathologists' Proficiency Testing Program.

Objective: This study was conducted to determine the spectrum of laboratory practices in antinuclear antibody (ANA) test target, performance, and result reporting.

Methods: A questionnaire on ANA testing was distributed by the Diagnostic Immunology and Flow Cytometry Committee of the College of American Pathologists (CAP) to laboratories participating in the 2016 CAP ANA proficiency survey.

Results: Of 5847 survey kits distributed, 1206 (21%) responded.

Screening and Diagnosis of Monoclonal Gammopathies: An International Survey of Laboratory Practice.

Context: - Serum tests used for the screening and diagnosis of monoclonal gammopathies include serum protein electrophoresis (SPE; agarose gel or capillary zone), immunofixation (IFE) and immunosubtraction capillary electrophoresis, serum free light chains, quantitative immunoglobulins, and heavy/light-chain combinations. Urine protein electrophoresis and urine IFE may also be used to identify Bence-Jones proteinuria.

Objective: - To assess current laboratory practice for monoclonal gammopathy testing.

Professional Practice Evaluation for Pathologists: The Development, Life, and Death of the Evalumetrics Program.

Context: - In 2008, the Joint Commission (JC) implemented a standard mandating formal monitoring of physician professional performance as part of the process of granting and maintaining practice privileges.

Objective: - To create a pathology-specific management tool to aid pathologists in constructing a professional practice-monitoring program, thereby meeting the JC mandate.

Design: - A total of 105 College of American Pathologists (CAP)-defined metrics were created.

Prevalence of Traditional and Reverse-Algorithm Syphilis Screening in Laboratory Practice: A Survey of Participants in the College of American Pathologists Syphilis Serology Proficiency Testing Program.

Context: -Syphilis serology screening in laboratory practice is evolving. Traditionally, the syphilis screening algorithm begins with a nontreponemal immunoassay, which is manually performed by a laboratory technologist. In contrast, the reverse algorithm begins with a treponemal immunoassay, which can be automated.

Assessing Clinical Laboratory Quality: A College of American Pathologists Q-Probes Study of Prothrombin Time INR Structures, Processes, and Outcomes in 98 Laboratories.

Context: The anticoagulant warfarin has been identified as the second most frequent drug responsible for serious, disabling, and fatal adverse drug events in the United States, and its effect on blood coagulation is monitored by the laboratory test called international normalized ratio (INR).

Objective: To determine the presence of INR policies and procedures, INR practices, and completeness and timeliness of reporting critical INR results in participants' clinical laboratories.

Design: Participants reviewed their INR policies and procedure requirements, identified their practices by using a questionnaire, and studied completeness of documentation and timeliness of reporting critical value INR results for outpatients and emergency department patients.

Seven Q-Tracks monitors of laboratory quality drive general performance improvement: experience from the College of American Pathologists Q-Tracks program 1999-2011.

Context: Many production systems employ standardized statistical monitors that measure defect rates and cycle times, as indices of performance quality. Clinical laboratory testing, a system that produces test results, is amenable to such monitoring.

Objective: To demonstrate patterns in clinical laboratory testing defect rates and cycle time using 7 College of American Pathologists Q-Tracks program monitors.

Q-Probes studies in anatomic pathology: quality improvement through targeted benchmarking.

Context: The Q-Probes program is a peer-comparison quality assurance service offered by the College of American Pathologists that was created in 1989.

Objective: To establish national benchmarks around a specific quality metric at a specific point in time in anatomic pathology (AP).

Design: Q-Probes are based on a voluntary subscription for an individual study.

Fifteen years' experience of a College of American Pathologists program for continuous monitoring and improvement.

Context: The Q-Tracks program, created in 1999, is a quality monitoring subscription service offered by the College of American Pathologists.

Objective: To establish benchmarks in quality metrics, monitor changes in performance over time, and identify practice characteristics associated with better performance.

Design: The Q-Tracks program provides ongoing study of multiple metrics offered in most laboratory disciplines.

Twenty-five years of accomplishments of the College of American Pathologists Q-probes program for clinical pathology.

Context: During the past 25 years, the College of American Pathologists' (CAP) Q-Probes program has been available as a subscription program to teach laboratorians how to improve the quality of clinical laboratory services.

Objective: To determine the accomplishments of the CAP Q-Probes program.

Design: We reviewed Q-Probes participant information, study data and conclusions, author information, and program accomplishments.

Monitoring and ordering practices for human papillomavirus in cervical cytology: findings from the College of American Pathologists Gynecologic Cytopathology Quality Consensus Conference working group 5.

Context: The association of certain types of human papillomavirus with cervical carcinoma is well established. Human papillomavirus testing is now routinely used to screen for cervical carcinoma and precursor lesions of the cervix (cotesting and reflex testing) and these results are considered in patient triage and management.

Objective: To provide information about current laboratory practices in human papillomavirus testing and consensus best practice statements based on results from the College of American Pathologists' laboratory-based survey funded by the Centers for Disease Control and Prevention.