Facing the Inevitable: Being Prepared for Regulatory Requirements for Laboratory Developed Tests.

OBJECTIVES: We introduce regulatory terms, definitions, and the Quality System Regulation as proposed by the US Food and Drug Administration in the 2014 draft guidance entitled Framework for Regulatory Oversight of Laboratory Developed Tests and explore medical device requirements applicable to a laboratory environment to design, develop, and validate laboratory developed tests (LDTs). METHODS: We performed nine interviews with laboratory professionals to explore concerns and challenges regarding the draft, translated the results into operational factors, and surveyed professionals to test the factors that would comprise a regulatory quality management system framework. RESULTS: Nine interviewees and 35 survey respondents shared concerns of risk classification, process validation, patient safety, and general ambiguity regarding the proposed requirements for development of LDTs. CONCLUSIONS: Respondents agree that a regulatory quality management system is needed in laboratories that develop LDTs, but the translation and method for design control to a clinical laboratory do not exist. As a result, laboratories are taking the wait-and-see approach.

Getting It Right for Patient Safety: Specimen Collection Process Improvement From Operating Room to Pathology.

OBJECTIVES: Specimen labeling defects within the perioperative environment are a known patient safety risk that carries the potential for adverse outcomes. These outcomes are a result of errors that occur when unsuspecting providers operate within poorly designed processes with little control over the specimen collection context. Many costly outcomes resulting from labeling errors may include patient harm, inappropriate treatments, lengthy investigations, corrective actions, and, at times, legal action. METHODS: This improvement initiative to identify and reduce the risk of specimen labeling defects includes the application of a disciplined Lean problem-solving approach with the engagement of employees who actually perform the work. RESULTS: By listening to the voice of our internal customers, we collectively redesigned the workflow by collaboratively linking work teams of the operating room and Pathology Department of Henry Ford Hospital, Detroit, over a 2-year period. CONCLUSIONS: We illustrate successful interventions achieved by Lean process management by streamlining, standardizing, and mistake proofing the processes and eliminating waste and inefficiency through systematic problem solving.

Daily Management System of the Henry Ford Production System: QTIPS to Focus Continuous Improvements at the Level of the Work.

OBJECTIVES: To support our Lean culture of continuous improvement, we implemented a daily management system designed so critical metrics of operational success were the focus of local teams to drive improvements. METHODS: We innovated a standardized visual daily management board composed of metric categories of Quality, Time, Inventory, Productivity, and Safety (QTIPS); frequency trending; root cause analysis; corrective/preventive actions; and resulting process improvements. RESULTS: In 1 year (June 2013 to July 2014), eight laboratory sections at Henry Ford Hospital employed 64 unique daily metrics. Most assessed long-term (>6 months), monitored process stability, while short-term metrics (1-6 months) were retired after successful targeted problem resolution. Daily monitoring resulted in 42 process improvements. CONCLUSIONS: Daily management is the key business accountability subsystem that enabled our culture of continuous improvement to function more efficiently at the managerial level in a visible manner by reviewing and acting based on data and root cause analysis.

Developing and pilot testing practical measures of preanalytic surgical specimen identification defects.

Accurate patient identification is a National Patient Safety Goal. Misidentification of surgical specimens is associated with increased morbidity, mortality, and costs of care. The authors developed 12 practical, process-based, standardized measures of surgical specimen identification defects during the preanalytic phase of pathology testing (from the operating room to the surgical pathology laboratory) that could be used to quantify the occurrence of these defects. The measures (6 container and 6 requisition identification defects) were developed by a panel of physicians, pathologists, nurses, and quality experts. A total of 69 hospitals prospectively collected data over 3 months. Overall, there were identification defects in 2.9% of cases (1780/60 501; 95% confidence interval [CI] = 2.0%-4.4%), 1.2% of containers (1018/81 656; 95% CI = 0.8%-2.0%), and 2.3% of requisitions (1417/61 245; 95% CI = 1.2%-4.6%). Future research is needed to evaluate if hospitals are able to use these measures to assess interventions meant to reduce the frequency of specimen identification defects and improve patient safety.

The Henry Ford production system: LEAN process redesign improves service in the molecular diagnostic laboratory: a paper from the 2008 William Beaumont hospital symposium on molecular pathology.

Accurate and timely molecular test results play an important role in patient management; consequently, there is a customer expectation of short testing turnaround times. Baseline data analysis revealed that the greatest challenge to timely result generation occurred in the preanalytic phase of specimen collection and transport. Here, we describe our efforts to improve molecular testing turnaround times by focusing primarily on redesign of preanalytic processes using the principles of LEAN production. Our goal was to complete greater than 90% of the molecular tests in less than 3 days. The project required cooperation from different laboratory disciplines as well as individuals outside of the laboratory. The redesigned processes involved defining and standardizing the protocols and approaching blood and tissue specimens as analytes for molecular testing. The LEAN process resulted in fewer steps, approaching the ideal of a one-piece flow for specimens through collection/retrieval, transport, and different aspects of the testing process. The outcome of introducing the LEAN process has been a 44% reduction in molecular test turnaround time for tissue specimens, from an average of 2.7 to 1.5 days. In addition, extending LEAN work principles to the clinician suppliers has resulted in a markedly increased number of properly collected and shipped blood specimens (from 50 to 87%). These continuous quality improvements were accomplished by empowered workers in a blame-free environment and are now being sustained with minimal management involvement.

The Henry Ford Production System: reduction of surgical pathology in-process misidentification defects by bar code-specified work process standardization.

Misidentification defects are a potential patient safety issue in medicine, including in the surgical pathology laboratory. In addressing the Joint Commission's national patient safety goal of accurate patient and specimen identification, we focused our lens internally on our own laboratory processes, with measurement tools designed to identify potential misidentification defects and their root causes. Based on this knowledge, aligned with our lean work culture in the Henry Ford Production System, we redesigned our surgical pathology laboratory workflow with simplified connections and pathways reinforced by a bar code technology innovation to specify and standardize work processes. We also adopted just-in-time prestain slide labeling with solvent-impervious, bar-coded slide labels at the microtome station, eliminating the loop-back pathway of poststain, batch slide matching, and labeling with adhesive paper labels. These changes have enabled us to dramatically reduce the overall misidentification case rate by approximately 62% with an approximate 95% reduction in the more common histologic slide misidentification defects while increasing technical throughput at the histology microtomy station by 125%.

The Henry ford production system: effective reduction of process defects and waste in surgical pathology.

By adopting a cultural transformation in its employees' approach to work and using manufacturing based continuous quality improvement methods, the surgical pathology division of Henry Ford Hospital, Detroit, MI, focused on reducing commonly encountered defects and waste in processes throughout the testing cycle. At inception, the baseline in-process defect rate was measured at nearly 1 in 3 cases (27.9%). After the year-long efforts of 77 workers implementing more than 100 process improvements, the number of cases with defects was reduced by 55% to 1 in 8 cases (12.5%), with a statistically significant reduction in the overall distribution of defects (P = .0004). Comparison with defects encountered in the pre-improvement period showed statistically significant reductions in pre-analytic (P = .0007) and analytic (P = .0002) test phase processes in the post-improvement period that included specimen receipt, specimen accessioning, grossing, histology slides, and slide recuts. We share the key improvements implemented that were responsible for the overall success in reducing waste and re-work in the broad spectrum of surgical pathology processes.

The Henry Ford Production System: measures of process defects and waste in surgical pathology as a basis for quality improvement initiatives.

We implemented a continuous quality improvement initiative in pursuit of a "zero-defects" performance goal in surgical pathology that required design of novel data collection tools to assess our current condition and sources of defects and waste. We defined defect as a flaw, an imperfection, or a deficiency in specimen processing requiring delaying or stopping work or returning work to the sender. These defects were noninterpretive, nondiagnostic defects critical to quality. Through a blameless work environment and contributions from all workers, we defined a baseline surgical pathology case defect rate of 27.9%, mostly arising in the laboratory (89.3%); only 8.3% were preanalytic; 2.4% resulted in amended reports. Additional focus on fidelity of patient and specimen identification allowed us to define defective identification in 1.67% of cases, with blocks and slides accounting for 78% of the defects. The misidentification defect rates per million opportunities for all sources were 4.3 to 4.8 sigma. These misidentification defects for 3 weeks required 159 hours of manual rework, or an annualized 1.3 full-time-equivalent employees. We found that through deep and honest exposure and the concerted effort of all workers, we could identify numerous sources of waste in our processes. This knowledge formed the structure for effective changes to strive toward a zero-defect performance goal.