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' standard work whereby knowledge of nonconformities assists in directing corrective actions and continuous improvements that promote consistent execution and higher levels of performance.

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.

Histologic validation of vacuum sealed, formalin-free tissue preservation, and transport system.

We describe five validation trials of new vacuum sealing technologies that change the approach to the preanalytic "front end" of specimen transport, handling, and processing and illustrate their adaptation and integration into existing Lean laboratory operations with reduction in formalin use and personnel exposure to this toxic and potentially carcinogenic fixative. These trials provide histologic assessment by numerous pathologists of tissues processed in this new paradigm and define the financial advantages of applying this technology to the postanalytic or "back end" process of tissue storage. We conclude that the TisssueSAFE and SealSAFE vacuum sealing systems are both promising technologies for preserving fresh human specimens that can promote a safer environment by markedly reducing formalin use in operating room theaters and can minimize formalin use by laboratories.

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.

Study of amended reports to evaluate and improve surgical pathology processes.

BACKGROUND: : Amended surgical pathology reports record defects in the process of transforming tissue specimens into diagnostic information. OBJECTIVE: : Systematic study of amended reports tests 2 hypotheses: (a) that tracking amendment frequencies and the distribution of amendment types reveals relevant aspects of quality in surgical pathology's daily transformation of specimens into diagnoses and (b) that such tracking measures the effect, or lack of effect, of efforts to improve surgical pathology processes. MATERIALS AND METHODS: : We applied a binary definition of altered reports as either amendments or addenda and a taxonomy of defects that caused amendments as misidentifications, specimen defects, misinterpretations, and report defects. During the introduction of a LEAN process improvement approach-the Henry Ford Productions System-we followed trends in amendment rates and defect fractions to (a) evaluate specific interventions, (b) sort case-by-case root causes of misidentifications, specimen defects, and misinterpretations, and (c) audit the ongoing accuracy of the classification of changed reports. LEAN is the management and production system of the Toyota Motor Corporation that promotes continuous improvement; it considers wasted resources expended for purposes other than creating value for end customers and targets such expenditures for elimination. RESULTS: : Introduction of real-time editing of amendments saw annual amendment rates increase from 4.8/1000 to 10.1/1000 and then decrease in an incremental manner to 5.6/1000 as Henry Ford Productions System-specific interventions were introduced. Before introduction of HFPS interventions, about a fifth of the amendments were due to misidentifications, a 10th were due to specimen defects, a quarter due to misinterpretation, and almost half were due to report defects. During the period of the initial application of HFPS, the fraction of amendments due to misidentifications decreased as those due to report defects increased, in a statistically linked manner. As HFPS interventions took hold, misidentifications fell from 16% to 9%, specimen defect rates remained variable, ranging between 2% and 11%, and misinterpretations fell from 18% to 3%. Reciprocally, report defects rose from 64% to 83% of all amendment-causing defects. A case-by-case study of misidentifications, specimen defects, and misinterpretations found that (a) intervention at the specimen collection level had disappointingly little effect on patient misidentifications; (b) standardization of specimen accession and gross examination reduced only specimen defects surrounding ancillary testing; but (c) a double review of breast and prostate cases was associated with drastically reduced misinterpretation defects. Finally, audit of both amendments and addenda demonstrated that 10% of the so-called addenda actually qualified as amendments. DISCUSSION: : Monitored by the consistent taxonomy, rates of amended reports first rose, then fell. Examining specific defect categories provided information for evaluating specific LEAN interventions. Tracking the downward trend of amendment rates seemed to document the overall success of surgical pathology quality improvement efforts. Process improvements modestly decreased fractions of misidentifications and markedly decreased misinterpretation fractions. Classification integrity requires real time, independent editing of both amendments (changed reports) and addenda (addition to reports).

Clinical performance of JAK2 V617F mutation detection assays in a molecular diagnostics laboratory: evaluation of screening and quantitation methods.

The presence of the JAK2 V617F mutation is now part of clinical diagnostic algorithms, and JAK2 status is routinely assessed when BCR/ABL- chronic myeloproliferative neoplasms (MPNs) are suspected. The aim of this study was to evaluate performance of 3 screening and 1 quantitative method for JAK2 V617F detection. For the study, 43 samples (27 bone marrow aspirates and 16 peripheral blood samples) were selected. The screening assays were the JAK2 Activating Mutation Assay (InVivoScribe, San Diego, CA), JAK2 MutaScreen kit (Ipsogen, Luminy Biotech, Marseille, France), and a home-brew melting curve analysis method. Ipsogen's JAK2 MutaQuant assay was used for quantification of mutant and wild-type alleles. The limit of detection was 1% for the kit-based screening methods and 10% for the melting curve method. The JAK2 MutaQuant assay demonstrated analytic sensitivity of 0.01%. All 4 methods detected cases of BCR/ABL- MPNs and gave negative results with BCR/ABL+ chronic myelogenous leukemia, multiple myeloma, myelodysplastic syndrome, and normal cases.

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%.

Amended reports: development and validation of a taxonomy of defects.

Amended pathology reports produce rework, confusion, and distrust. To develop a reproducible amendment taxonomy we derived a classification from 141 amended reports, then validated it with 130 new cases before 4 observers independently reviewed 430 cases measuring agreement (k). Next, agreement in classifying 30 other amended reports in 7 institutions was measured. We further tracked amendment rates, defect categories, defect discoverers, and discovery mechanisms. In the 430-case validation set agreement was excellent (k = 0.8780 [range, 0.8416-0.9144]). Among the 7 institutions, agreement was good (k = 0.6235 [range, 0.3105-0.8975]). Amendment rates ranged from 2.6 to 4.8 per 1,000 reports. Misinterpretation fractions varied least (23%-29%). Misidentification fractions ranged more widely (20%-38%). Specimen defects were least frequent (4%-10%) and report defects most frequent (29%-48%). Misidentifications and report defects inversely correlated. Pathologists discovered most misinterpretations, and clinicians found most misidentifications. Conference review revealed 40% to 80% of misinterpretations. This taxonomy produced excellent reproducibility and good agreement across institutions.

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.

Frequency and outcome of cervical cancer prevention failures in the United States.

We measured the frequency and outcome of cervical cancer prevention failures that occurred in the Papanicolaou (Pap) and colposcopy testing phases involving 1,646,580 Pap tests in 4 American hospital systems between January 1, 1998, and December 31, 2004. We defined a screening failure as a 2-step or greater discordant Pap test result and follow-up biopsy diagnosis. A total of 5,278 failures were detected (0.321% of all Pap tests); 48% and 52% of failures occurred in the Pap test and colposcopy phases, respectively. Missed squamous cancers (1 in 187,786 Pap tests), glandular cancers (1 in 19,426 Pap tests), and high-grade lesions (1 in 6,870 Pap tests) constituted 4.1% of all failures. Unnecessary repeated tests or diagnostic delays occurred in 70.8% and 63.9% of failures involving high- and low-grade lesions, respectively. We conclude that cervical cancer prevention practices are remarkably successful in preventing squamous cancers, although a high frequency of failures results in low-impact negative outcomes.

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.

Clinical laboratory specimen rejection--association with the site of patient care and patients' characteristics: findings from a single health care organization.

CONTEXT: Programs to track laboratory quality have reported aggregated specimen rejection rates ranging from 0.30% to 0.83%. Because the performance of the laboratory, rather than errors, has been the focus, reasons for specimen rejection or demographic characteristics of individuals at risk for specimens of poor quality may not be fully understood. OBJECTIVE: To calculate the proportions of rejected specimens stratified by point of collections and demographic information of patients. DESIGN: Retrospective cross-sectional study. Data were retrieved from the intrainstitutional electronic databases. RESULTS: The proportions of specimens that were rejected in the emergency department and inpatient services were 2-fold and more than 5-fold higher, respectively, than for the outpatient services. Assessment of data by patients' ethnic heritages yielded no significant differences among African Americans (0.38%), Caucasians (0.38%), or "Others" (0.35%) in the outpatient services (P = .07). In the emergency department, the proportions of rejected specimens for African Americans (2.24%) were almost twice that of Caucasians (1.39%) and 30% higher than for Others (1.70%). A similar finding was observed for the inpatient services. CONCLUSIONS: The effect of ethnicity on the proportions of rejected specimens was significant for samples that were collected in the emergency department and inpatient services, even after adjusting for the total number of specimens. A constellation of factors, that is, disease severity and seriousness, practice of blood sample collection, and lesser proficiency of the nursing staff in phlebotomy may be reasons for this observation. However, the likelihood of differential care, although unlikely, cannot be refuted by the present data.

A simplified laboratory validated assay for MGMT promoter hypermethylation analysis of glioma specimens from formalin-fixed paraffin-embedded tissue.

Glioma, and in particular high-grade astrocytoma termed glioblastoma multiforme (GBM), is the most common primary tumor of the brain. Epigenetic silencing of the MGMT (O(6)-methylguanine-DNA Methyl transferase) DNA repair gene by promoter methylation compromises DNA repair and has been associated with longer survival in patients with GBM who receive alkylating agents. The methylation status of the MGMT promoter is determined by methylation-specific polymerase chain reaction analysis (MSP). This protocol is often challenging with GBM specimens, because of extensive necrosis and scarcity of malignant cells. The objective of this study was to develop a reliable, clinically validated assay for detection of epigenetic silencing of the MGMT gene using formalin-fixed, paraffin-embedded brain tumor resections and methylation-specific PCR.

NF-kappaB in breast cancer cells promotes osteolytic bone metastasis by inducing osteoclastogenesis via GM-CSF.

Advanced breast cancers frequently metastasize to bone, resulting in osteolytic lesions, yet the underlying mechanisms are poorly understood. Here we report that nuclear factor-kappaB (NF-kappaB) plays a crucial role in the osteolytic bone metastasis of breast cancer by stimulating osteoclastogenesis. Using an in vivo bone metastasis model, we found that constitutive NF-kappaB activity in breast cancer cells is crucial for the bone resorption characteristic of osteolytic bone metastasis. We identified the gene encoding granulocyte macrophage-colony stimulating factor (GM-CSF) as a key target of NF-kappaB and found that it mediates osteolytic bone metastasis of breast cancer by stimulating osteoclast development. Moreover, we observed that the expression of GM-CSF correlated with NF-kappaB activation in bone-metastatic tumor tissues from individuals with breast cancer. These results uncover a new and specific role of NF-kappaB in osteolytic bone metastasis through GM-CSF induction, suggesting that NF-kappaB is a potential target for the treatment of breast cancer and the prevention of skeletal metastasis.