Raising the Bar: Improving Antimicrobial Resistance Detection by Clinical Laboratories by Ensuring Use of Current Breakpoints.

Background: Antimicrobial resistance (AMR) is a pressing global challenge detected by antimicrobial susceptibility testing (AST) performed by clinical laboratories. AST results are interpreted using clinical breakpoints, which are updated to enable accurate detection of new and emerging AMR. Laboratories that do not apply up-to-date breakpoints impede global efforts to address the AMR crisis, but the extent of this practice is poorly understood.

An International Survey of Glucose-6-Phosphate Dehydrogenase Laboratory Reporting Practices.

Context.—: Glucose-6-phosphate dehydrogenase (G6PD) activity is used in the evaluation of hemolysis risk in patients being assessed for G6PD deficiency. A long-acting 8-aminoquinoline drug (tafenoquine) used in malaria treatment is contraindicated in patients with G6PD deficiency (<70% normal G6PD activity).

Neoplastic Cellularity Assessment in Molecular Testing.

Context.—: Neoplastic cellularity assessment has become an essential component of molecular oncology testing; however, there are currently no best practice recommendations or guidelines for this potentially variable step in the testing process.

Objective.

An International Survey of Glucose-6-Phosphate Dehydrogenase Laboratory Reporting Practices: Implications for Tafenoquine Eligibility Assessment.

Context.—: Glucose-6-phosphate dehydrogenase (G6PD) activity is used in the evaluation of hemolysis risk in patients being assessed for G6PD deficiency. A long-acting 8-aminoquinoline drug (tafenoquine) used in malaria treatment is contraindicated in patients with G6PD deficiency (<70% normal G6PD activity).

Chasm Between Cancer Quality Measures and Electronic Health Record Data Quality.

Purpose: The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) requires eligible clinicians to report clinical quality measures (CQMs) in the Merit-Based Incentive Payment System (MIPS) to maximize reimbursement. To determine whether structured data in electronic health records (EHRs) were adequate to report MIPS CQMs, EHR data aggregated by ASCO's CancerLinQ platform were analyzed.

Materials And Methods: Using the CancerLinQ health technology platform, 19 Oncology MIPS (oMIPS) CQMs were evaluated to determine the presence of data elements (DEs) necessary to satisfy each CQM and the DE percent population with patient data (fill rates).

Tiered Somatic Variant Classification Adoption Has Increased Worldwide With Some Practice Differences Based on Location and Institutional Setting.

Context.—: The 2017 Association for Molecular Pathology/American Society of Clinical Oncology/College of American Pathologists (CAP) tier classification guideline provides a framework to standardize interpretation and reporting of somatic variants.

Objective.

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).

Performance of specific morphologic features in distinguishing low-grade squamous intraepithelial lesions from high-grade squamous intraepithelial lesions in borderline cases: a College of American Pathologists Cytopathology Committee multiobserver study.

Introduction: Distinguishing between low-grade squamous intraepithelial lesions (LSIL) and high-grade squamous intraepithelial lesions (HSIL) can be difficult on certain Papanicolaou (Pap) tests, hindering interobserver concordance. We investigated the variables influencing the interpretation of LSIL versus HSIL in Pap test slides rejected from the College of American Pathologists PAP education program.

Materials And Methods: Eleven cytologists, who were unaware of the reference interpretation, examined 21 Pap slides (11 submitted as LSIL and 10 as HSIL) rejected from the PAP education program and recorded the number of LSIL cells, HSIL cells, keratinized dysplastic cells, LSIL clusters with mixed HSIL cells, atypical squamous metaplasia, atypical glandular cells, the presence of inflammation or infectious organisms, and the overall interpretation (LSIL or HSIL).

Phlebotomy Staffing.

Context.—: Laboratory directors are tasked with staffing laboratories in a manner that provides adequate services and maintains economic sustainability.

Objective.

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.

Next-Generation Sequencing Somatic and Germline Assay Troubleshooting Guide Derived From Proficiency Testing Data.

Context.—: Next-generation sequencing-based assays are increasingly used in clinical molecular laboratories to detect somatic variants in solid tumors and hematologic malignancies and to detect constitutional variants. Proficiency testing data are potential sources of information about challenges in performing these assays.

Laboratory Detection and Initial Diagnosis of Monoclonal Gammopathies.

Context.—: The process for identifying patients with monoclonal gammopathies is complex. Initial detection of a monoclonal immunoglobulin protein (M protein) in the serum or urine often requires compilation of analytical data from several areas of the laboratory.

Technical Staffing Ratios.

Context.—: Laboratory managers and medical directors are charged with staffing their clinical laboratories as efficiently as possible.

Objective.

The College of American Pathologists Foundation's See, Test & Treat Program®: an Evaluation of a One-Day Cancer Screening Program Implemented in Mississippi.

Women in Mississippi experience significant barriers to healthcare that results in high incidence rates of late-stage breast, cervical, and oropharyngeal cancer. We implemented See, Test, & Treat, a cancer screening and education program, that was aimed at increasing access to cancer screening for underserved women in the Jackson Metropolitan Area. During the event, 103 women between the ages of 21 and 69 years old received breast, cervical, and/or oral cancer screenings.

Interlaboratory Performance in Measurement of Dabigatran and Rivaroxaban.

Context.—: Assessing direct oral anticoagulant (DOAC) drug levels by reliable laboratory assays is necessary in a number of clinical scenarios.

Objective.

Improving Oncology-Pathology Collaboration in Resource-Limited Settings: An American Society of Clinical Oncology/College of American Pathologists Initiative.

Accurate pathologic evaluation is essential for proper diagnosis and treatment of patients with cancer. ASCO and the College of American Pathologists have successfully collaborated over the last 15 years to improve collaboration between clinical oncologists and pathologists and to standardize pathologic assay techniques. Cancer is an increasingly recognized societal burden in low- and middle-income countries.

Validating Whole Slide Imaging Systems for Diagnostic Purposes in Pathology.

Context.—: The original guideline, "Validating Whole Slide Imaging for Diagnostic Purposes in Pathology," was published in 2013 and included 12 guideline statements. The College of American Pathologists convened an expert panel to update the guideline following standards established by the National Academies of Medicine for developing trustworthy clinical practice guidelines.

Rescreening Practices of Negative Papanicolaou Tests With Positive Human Papillomavirus Test Result.

Context.—: The yield of the prospective rescreening process for "negative for intraepithelial lesion or malignancy" (NILM) Papanicolaou (Pap) tests is higher with the inclusion of a greater proportion of high-risk cases. One of the suggested criteria for classifying a Pap test finding as high risk is recent or concurrent high-risk human papillomavirus (HPV) positivity.

Evidence-Based Alignment of Pathology Residency With Practice II: Findings and Implications.

This article presents findings from a 4-year series of surveys of new-in-practice pathologists, and a survey of physician employers of new pathologists, assessing how pathology graduate medical education prepares its graduates for practice. Using the methodology described in our previous study, we develop evidence for the importance of residency training for various practice areas, comparing findings over different practice settings, sizes, and lengths of time in practice. The principal findings are (1) while new-in-practice pathologists and their employers report residency generally prepared them well for practice, some areas-billing and coding, laboratory management, molecular pathology, and pathology informatics-consistently were identified as being important in practice but inadequately prepared for in residency; (2) other areas-autopsy pathology, and subspecialized apheresis and blood donor center blood banking services-consistently were identified as relatively unimportant in practice and excessively prepared for in residency; (3) the notion of a single comprehensive model for categorical training in residency is challenged by the disparity between broad general practice in some settings and narrower subspecialty practice in others; and (4) the need for preparation in some areas evolves during practice, raising questions about the appropriate mode and circumstance for training in these areas.

Laboratory and Clinical Implications of Incidental and Secondary Germline Findings During Tumor Testing.

Context.—: Next-generation sequencing is a powerful clinical tool for cancer management but can produce incidental/secondary findings that require special consideration.

Objective.

Therapeutic Drug Monitoring of Second- and Third-Generation Antiepileptic Drugs.

Context.—: Therapeutic drug monitoring has traditionally been widely used for first-generation antiepileptic drugs (AEDs) such as carbamazepine and phenytoin. The last 2 decades have seen the introduction of second- and third-generation AEDs (eg, lamotrigine, levetiracetam, and topiramate) into clinical practice.

Heterogeneity in Approaches for Switching From Universal to Patient ABO Type-Specific Blood Components During Massive Hemorrhage.

Context.—: ABO mistransfusions are rare and potentially fatal events. Protocols are required by regulatory agencies to minimize this risk to patients, but how these are applied in the context of massive transfusion protocols (MTPs) is not specifically defined.

Ethanol Biomarker Testing and Challenges.

Context.—: Clinical and forensic testing for ethanol biomarkers, including ethyl glucuronide (EtG) and ethyl sulfate (EtS), is used to discern alcohol use from abstinence. These markers can be key in major decisions, including transplant eligibility or retaining licensure after alcohol misuse.