Advances in the Diagnosis of Urothelial Neoplasia

Urothelial neoplasia is a unique cancer in that it consists of a spectrum of tumors with different biologic behaviors. The most common urothelial neoplasm is the low grade superficial papillary carcinoma or papilloma which may recur numerous times but does not result in significant morbidity or mortality. A variant of the superficial papillary carcinoma, which represents approximately 10% of the tumors, is the noninvasive papillary neoplasm which progresses to a less differentiated invasive transitional cell carcinoma (TCC). Considerable effort has been directed at identifying which of the superficial well differentiated papillary tumors will persist, recur and progress to invasive cancer Current approaches to identifying such tumors include cytogenetics, molecular biology, and flow cytometric DNA analysis. In the final group of bladder carcinomas, the high grade invasive neoplasms, evidence suggests that these life-threatening tumors arise de novo without identifiable precursors. Unfortunately, 75% to 90% of invasive TCCs are classified in this group, with the remaining minority progressing from preexisting recurrent superficial papillary carcinomas. Obviously the biologic behavior of these aggressive poorly differentiated tumors is life-threatening, and application of traditional diagnostic procedures and new technologies need to be directed at early diagnosis

A Proposed Set of Metrics to Reduce Patient Safety Risk From Within the Anatomic Pathology Laboratory

Background: Anatomic pathology laboratory workflow consists of 3 major specimen handling processes. Among the workflow are preanalytic, analytic, and postanalytic phases that contain multistep subprocesses with great impact on patient care. A worldwide representation of experts came together to create a system of metrics, as a basis for laboratories worldwide, to help them evaluate and improve specimen handling to reduce patient safety risk. Method: Members of the Initiative for Anatomic Pathology Laboratory Patient Safety (IAPLPS) pooled their extensive expertise to generate a list of metrics highlighting processes with high and low risk for adverse patient outcomes. Results: Our group developed a universal, comprehensive list of 47 metrics for patient specimen handling in the anatomic pathology laboratory. Steps within the specimen workflow sequence are categorized as high or low risk. In general, steps associated with the potential for specimen misidentification correspond to the high-risk grouping and merit greater focus within quality management systems. Primarily workflow measures related to operational efficiency can be considered low risk. Conclusion: Our group intends to advance the widespread use of these metrics in anatomic pathology laboratories to reduce patient safety risk and improve patient care with development of best practices and interlaboratory error reporting programs

Management Systems to Structure Continuous Quality Improvement

OBJECTIVES: This review describes the processes and effectiveness of the primary management systems that structure and sustain consistent behaviors and result in a transformed culture of continuous quality improvement (CQI) from top to bottom throughout the Henry Ford medical laboratory enterprise. METHODS: Through a 17-year focus to achieve a functional CQI enterprise, quality management systems were developed and continuously improved by teams of laboratory leaders, managers, and quality specialists to coordinate and standardize human efforts, and provide actionable knowledge and data to engage improvement efforts at all levels of work. Lean and ISO 15189 discipline and requirements were addressed in annual management review of functionality and effectiveness to close gaps and further refine the management systems. RESULTS: Improvements in the use and effectiveness of 4 management systems are illustrated. CONCLUSIONS: The 4 primary management systems that provide structure and support transformation to a culture of CQI are the team leader, Plan-Do-Check-Act problem-solving, deviation management, and daily management systems. These management systems are designed to deepen the effectiveness of the continuous improvement culture by helping managers understand variation in the work they oversee and providing guidance for more effective employee engagement in the daily processes of quality improvement

Deviation Management: Key Management Subsystem Driver of Knowledge-Based Continuous Improvement in the Henry Ford Production System

Objectives: To develop a business subsystem fulfilling International Organization for Standardization 15189 nonconformance management regulatory standard, facilitating employee engagement in problem identification and resolution to effect quality improvement and risk mitigation. Methods: From 2012 to 2016, the integrated laboratories of the Henry Ford Health System used a quality technical team to develop and improve a management subsystem designed to identify, track, trend, and summarize nonconformances based on frequency, risk, and root cause for elimination at the level of the work. Results: Programmatic improvements and training resulted in markedly increased documentation culminating in 71,641 deviations in 2016 classified by a taxonomy of 281 defect types into preanalytic (74.8%), analytic (23.6%), and postanalytic (1.6%) testing phases. The top 10 deviations accounted for 55,843 (78%) of the total. Conclusions: Deviation management is a key subsystem of managers\u27 standard work whereby knowledge of nonconformities assists in directing corrective actions and continuous improvements that promote consistent execution and higher levels of performance