A Decade of Prospective Peer Review: Impact on Safety Culture and Lessons Learned in a Multicenter Radiation Medicine Department.

PURPOSE: Quality assurance (QA) is critical to the success of radiation therapy (RT) for patients with cancer and affects clinical outcomes. We report longitudinal findings of a prospective peer review evaluation system implemented at a major academic health system as part of RT QA during a 10-year period. METHODS AND MATERIALS: All cases treated within our department undergo prospective multidisciplinary peer review and are assigned a grade (A, B, or C). "A" cases require no changes, "B" cases require minor modification, and "C" cases require major modification before treatment planning. The z-ratio test for the significance of the difference between the 5-year baseline (2012-2016) and follow-up (2017-2021) period was used to compare grades between the 2 periods. A 2-tailed P value <.05 was considered significant. RESULTS: Of the 20,069 cases, 15,659 (78%) were curative and were analyzed. The fraction of A cases decreased from 74.8% (baseline) to 64.5% (follow-up), whereas B cases increased from 19.4% to 35.4% and C cases decreased from 5.8% to 0.1%. Of the 9 treatment locations, the main hospital site had a higher percentage of A grades relative to community locations in the baseline (78.6% vs 67.8%; P < .002) and follow-up (66.9% vs 62.3%; P < .002) periods. There was a decrease in the percentage of A cases from the baseline to the follow-up period regardless of plan type (complex vs intermediate vs simple). There was a decrease in the percentage of A cases among specialists from baseline to follow-up (78.2% to 67.7%; P < .002) and among generalists from baseline to follow-up (69.7% to 61.7%; P < .002). CONCLUSIONS: Our 10-year experience in contour peer review identified increased opportunities in improving treatment plan quality over time. The drop in A scores and rise in B scores suggests increased scrutiny and findings-based improvements over time, whereas the drop in C scores indicates amelioration of "major failures" addressed in the startup years. Peer review rounds upstream of treatment planning provide valuable RT QA and should be considered by other departments to enhance the quality and consistency of RT.

The impact of the COVID-19 pandemic on glycaemic control in people with diabetes: A systematic review and meta-analysis.

AIM: To identify, appraise and synthesize the available evidence on the impact of the coronavirus disease 2019 (COVID-19) pandemic and lockdown (LD) on glycaemic control in people with diabetes. MATERIALS AND METHODS: We searched multiple databases up to 2 February 2021 for studies reporting HbA1c, time in range (TIR), average or fasting glucose, severe hypoglycaemia and diabetic ketoacidosis. Data were pooled using random effects meta-analysis and are presented as mean difference (MD) with 95% confidence intervals (CI). This review was preregistered on PROSPERO (CRD42020179319). RESULTS: We include 59 studies; 44 (n = 15 464) were included in quantitative syntheses and 15 were narratively synthesized. Pooled data were grouped by diabetes type. Results from 28 studies (n = 5048 type 1 diabetes [T1D] and combined diabetes participants) showed that TIR increased during LD compared with before LD (MD 2.74%, 95% CI 1.80% to 3.69%). Data from 10 studies (n = 1294 T1D participants) showed that TIR increased after LD compared with before LD (MD 5.14%, 95% CI 3.12% to 7.16%). Pooled results from 12 studies (n = 4810 T1D and type 2 diabetes participants) resulted in average glucose decreasing after LD compared with before LD (MD -6.86 mg/dl, 95% CI -8.54 to -5.18). Results for other outcomes, including HbA1c, were not statistically significantly different. CONCLUSIONS: The COVID-19 pandemic was associated with small improvements across multiple outcomes of glycaemic control, although there was insufficient evidence to suggest that this led to changes in HbA1c. Most evidence came from people with access to diabetes technologies in high-income countries; more research is needed in less advantaged populations.

Assessing initial plan check efficacy using TG 275 failure modes and incident reporting.

Plan checks are important components of a robust quality assurance (QA) program. Recently, the American Association of Physicists in Medicine (AAPM) published two reports concerning plan and chart checking, Task Group (TG) 275 and Medical Physics Practice Guideline (MPPG) 11.A. The purpose of the current study was to crosswalk initial plan check failure modes revealed in TG 275 against our institutional QA program and local incident reporting data. Ten physicists reviewed 46 high-risk failure modes reported in Table S1.A.i of the TG 275 report. The committee identified steps in our planning process which sufficiently checked each failure mode. Failure modes that were not covered were noted for follow-up. A multidisciplinary committee reviewed the narratives of 1599 locally-reported incidents in our Radiation Oncology Incident Learning System (ROILS) database and categorized each into the high-risk TG 275 failure modes. We found that over half of the 46 high-risk failure modes, six of which were top-ten failure modes, were covered in part by daily contouring peer-review rounds, upstream of the traditional initial plan check. Five failure modes were not adequately covered, three of which concerned pregnancy, pacemakers, and prior dose. Of the 1599 incidents analyzed, 710 were germane to the initial plan check, 23.4% of which concerned missing pregnancy attestations. Most, however, were caught prior to CT simulation (98.8%). Physics review and initial plan check were the least efficacious checks, with error detection rates of 31.8% and 31.3%, respectively, for some failure modes. Our QA process that includes daily contouring rounds resulted in increased upstream error detection. This work has led to several initiatives in the department, including increased automation and enhancement of several policies and procedures. With TG 275 and MPPG 11.A as a guide, we strongly recommend that departments consider an internal chart checking policy and procedure review.

Posttraumatic Growth in Radiation Medicine During the COVID-19 Outbreak.

Purpose: It has been reported that adversarial growth during traumatic events potentially enhances coping with sequelae. The purpose of this work was to assess posttraumatic growth (PTG) among radiation medicine staff members at the individual level as well as changes in perceptions of departmental culture after the COVID-19 pandemic. Methods and Materials: An anonymous PTG inventory (PTGI) survey comprising 21 indicators was disseminated to all 213 members of our multicenter radiation department to measure perceptions of change in personal, interpersonal-relationship, and philosophy of life factors using principal-factor analysis. Additionally, 8 department safety-culture indicators from the National Hospital Patient Safety Culture Survey developed by the Agency for Healthcare Research and Quality were included to assess changes in department safety-culture perceptions verses a prepandemic survey. The survey was repeated 15 months later to assess longitudinal trends. Results: With a 56.3% survey-response rate, PTGI factor analysis yielded Cronbach's alpha values exceeding 0.90 for the 3 aforementioned PTG factors. The average growth per indicator was 2.3 (out of 5.0), which fell between small and moderate. The values were 2.4 (personal), 2.1 (interpersonal), and 1.6 (philosophy) for the 3 factors. The total PTGI score (47.7 ± 28.3 out of 105 points) was lower for masked, patient-facing, frontline workers members (41.8 ± 28.4) compared with others (53.1 ± 27.3, P value .001). For the Agency for Healthcare Research and Quality survey there was an improvement of 15% in perceptions of department safety culture, and 7 of the 8 indicators showed improvements compared with baseline. The follow-up survey demonstrated overall sustained findings, albeit with a trend toward declining PTG scores for nonfrontline workers, notably in interpersonal relationships (47.4 ± 27.0, P value .05). Conclusions: A fair-to-moderate degree of PTG was observed in personal and interpersonal relationship factors whereas least growth was noted in spiritual and religious beliefs. Perceptions of department patient-safety culture improved substantially. Sustained improvements were thus perceived at the individual and department levels.

Primary laparoscopic sleeve gastrectomy versus gastric bypass: a propensity-matched comparison of 30-day outcomes.

BACKGROUND: Bariatric surgery is the most effective treatment for obesity. There is uncertainty regarding rates of adverse outcomes between the most common methods: laparoscopic Roux-en-Y gastric bypass (LRYGB) and laparoscopic sleeve gastrectomy (LSG). OBJECTIVES: To compare rates of readmission, reoperation, intervention, unplanned intensive care unit (ICU) admission, all-cause and procedure-related mortality, and postoperative complications at 30 days between LRYGB and LSG. SETTING: Retrospective, observational, multicenter registry. METHODS: We identified 611,619 patients from the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) data registry between January 1, 2015, and December 31, 2018 (447,326 [73.1%] LSG; 164,293 [26.9%] LRYGB). RESULTS: Adverse events were more common after LRYGB (readmission: 3% with LSG versus 5.9% with LRYGB [P < .001; odds ratio {OR}, LSG/LRYGB = .489]; intervention: .9% with LSG versus 2.4% with LRYGB [P < .001; OR, LSG/LRYGB = .357]; reoperation: .8% with LSG versus 2.3% with LRYGB [P < .001; OR, LSG/LRYGB = .363]; unplanned ICU admission: .52% with LSG versus 1.1% with LRYGB [P < .001; OR, LSG/LRYGB = .454]; all-cause mortality: .07% with LSG versus .15% with LRYGB [P < .001; OR, LSG/LRYGB = .489]; procedure-related mortality: .04% with LSG versus .08% with LRYGB [P < .001; OR, LSG/LRYGB = .446]; Clavien-Dindo I: .20% with LSG versus .63% with LRYGB [P < .001; OR, LSG/LRYGB = .317]; Clavien-Dindo II: .70% with LSG versus 1.3% with LRYGB [P < .001; OR, LSG/LRYGB = .527]; Clavien-Dindo III: 3.3% with LSG versus 6.6% with LRYGB [P < .001; OR, LSG/LRYGB = .481]; Clavien-Dindo IV: .36% with LSG versus .76% with LRYGB [P < .001; OR, LSG/LRYGB = .466]; and Clavien-Dindo V: .07% with LSG versus .15% with LRYGB [P < .001; OR, LSG/LRYGB = .488]). Surgery type was among the strongest independent predictors of adverse events, and LRYGB conferred higher adjusted odds of all adverse outcomes (all-cause mortality: OR, LRYGB/LSG = 1.791 [P < .001]; procedure-related mortality: OR, LRYGB/LSG = 1.979 [P < .001]; readmission: OR, LRYGB/LSG = 1.921 [P < .001]; unplanned ICU admission: OR, LRYGB/LSG = 1.870 [P < .001]; intervention: OR, LRYGB/LSG = 2.662 [P < .001]; reoperation: OR, LRYGB/LSG = 2.646 [P < .001]; and Clavien-Dindo grade: OR, LRYGB/LSG = 2.007 [P < .001]). CONCLUSION: The rates of 30-day adverse outcomes are lower after LSG compared with after LRYGB. LRYGB independently conferred increased odds of adverse outcomes compared with LSG, and surgery type was among the strongest predictors of adverse outcomes.

Is Methylphenidate Beneficial and Safe in Pharmacological Cognitive Enhancement?

Nootropics are drugs used to either treat or benefit cognition deficits. Among this class, methylphenidate is a popular agent, which acts through indirect dopaminergic and noradrenergic agonism and, therefore, is proposed to enhance performance in catecholamine-dependent cognitive domains such as attention, memory and prefrontal cortex-dependent executive functions. However, investigation into the efficacy of methylphenidate as a cognitive enhancer has yielded variable results across all domains, leading to debate within the scientific community surrounding its off-label use in healthy individuals seeking scholaristic benefit or increased productivity. Through analysis of experimental data and methodological evaluation, it is apparent that there are dose-, task- and domain-dependent considerations surrounding the use of methylphenidate in healthy individuals, whereby tailored dose administration is likely to provide benefit on an individual basis dependent on the domain of cognition in which benefit is required. Additionally, it is apparent that there are subjective effects of methylphenidate, which may increase user productivity irrespective of cognitive benefit. Whilst there is not extensive study in healthy older adults, it is plausible that there are dose-dependent benefits to methylphenidate in older adults in selective cognitive domains that might improve quality of life and reduce fall risk. Methylphenidate appears to produce dose-dependent benefits to individuals with attention-deficit/hyperactivity disorder, but the evidence for benefit in Parkinson's disease and schizophrenia is inconclusive. As with any off-label use of pharmacological agents, and especially regarding drugs with neuromodulatory effects, there are inherent safety concerns; epidemiological and experimental evidence suggests there are sympathomimetic, cardiovascular and addictive considerations, which might further restrict their use within certain demographics.

Prospective Peer Review in Radiation Therapy Treatment Planning: Long-Term Results From a Longitudinal Study.

PURPOSE: To present the longitudinal results of a prospective peer review evaluation system (PES) before treatment planning. METHODS AND MATERIALS: All cases undergoing radiation therapy (RT) at high-volume academic institutions were graded in daily prospective multidisciplinary contouring rounds (CRs). The clinical suitability for RT, prescription, contours, and written directives were peer reviewed, compared with departmental care pathways, and recorded in a prospective database. Grades were assigned as follows: A (score 4.0) = no deficiencies; B (3.0) = minor modifications of the planning target volume, organs at risk, written directives, or a prescription/care pathway mismatch; and C (2.0) = incomplete target volume or organ-at-risk contours, unsuitable use or inappropriate planned administration of RT, significant contour modifications, prescription changes, or laterality modifications. Information was pooled to determine pretreatment planning work performance by assigning a grade point average (GPA) for each physician as well as compositely. RESULTS: A total of 11,843 treatment plans from 7854 patients were reviewed using the PES from September 2013 to May 2018. Twenty-seven point nine percent of cases (n = 3303) required modifications before treatment planning commenced. The overall breakdown of grades was 72.1% As, 21.7% Bs, and 6.2% Cs. The median physician CR GPA was 3.60 (average 3.7) with a range of 3.0 to 3.9. Seventy-five percent of physicians demonstrated improvement of their CR GPA since inception of the program, and all physicians demonstrated a drop in the percentage of cases that were assigned a grade of C. CONCLUSIONS: The PES can transparently quantify clinical performance in a single metric. The PES was impactful, with 75% of physicians demonstrating improvement in their CR GPA over time. In contrast to traditional chart rounds, this peer review was meaningful when done before planning commenced, a trend that was observed throughout the study period. Twenty-seven point nine percent of all cases required modification before starting treatment planning, and 6.2% of cases required significant remediation.

Why Smart Oncology Clinicians do Dumb Things: A Review of Cognitive Bias in Radiation Oncology.

This review will discuss the (perhaps biased) way in which smart oncologists think, biases they can identify, and potential strategies to minimize the impact of bias. It is critical to understand cognitive bias as a significant risk (recognized by the Joint Commission) associated with patient safety, and cognitive bias has been implicated in major radiotherapy incidents. The way in which we think are reviewed, covering both System 1 and system 2 processes of thinking, as well as behavioral economics concepts (prospect theory, expected utility theory). Predisposing factors to cognitive error are explained, with exploration of the groupings of person factors, patient factors, and system factors which can influence the quality of our decision-making. Other factors found to influence decision making are also discussed (rudeness, repeated decision making, hunger, personal attitudes). The review goes on to discuss cognitive bias in the clinic and in workplace interactions (including recruitment), with practical examples provided of each bias. Finally, the review covers strategies to combat cognitive bias, including summarize aloud, crowd wisdom, prospective hindsight, and joint evaluation. More definitive ways to mitigate bias are desirable.

Improving efficiency and safety in external beam radiation therapy treatment delivery using a Kaizen approach.

INTRODUCTION: Modern external beam radiation therapy treatment delivery processes potentially increase the number of tasks to be performed by therapists and thus opportunities for errors, yet the need to treat a large number of patients daily requires a balanced allocation of time per treatment slot. The goal of this work was to streamline the underlying workflow in such time-interval constrained processes to enhance both execution efficiency and active safety surveillance using a Kaizen approach. METHODS AND MATERIALS: A Kaizen project was initiated by mapping the workflow within each treatment slot for 3 Varian TrueBeam linear accelerators. More than 90 steps were identified, and average execution times for each were measured. The time-consuming steps were stratified into a 2 × 2 matrix arranged by potential workflow improvement versus the level of corrective effort required. A work plan was created to launch initiatives with high potential for workflow improvement but modest effort to implement. Time spent on safety surveillance and average durations of treatment slots were used to assess corresponding workflow improvements. RESULTS: Three initiatives were implemented to mitigate unnecessary therapist motion, overprocessing of data, and wait time for data transfer defects, respectively. A fourth initiative was implemented to make the division of labor by treating therapists as well as peer review more explicit. The average duration of treatment slots reduced by 6.7% in the 9 months following implementation of the initiatives (P = .001). A reduction of 21% in duration of treatment slots was observed on 1 of the machines (P < .001). Time spent on safety reviews remained the same (20% of the allocated interval), but the peer review component increased. CONCLUSIONS: The Kaizen approach has the potential to improve operational efficiency and safety with quick turnaround in radiation therapy practice by addressing non-value-adding steps characteristic of individual department workflows. Higher effort opportunities are identified to guide continual downstream quality improvements.

In vivo dosimetry with optically stimulated luminescent dosimeters for conformal and intensity-modulated radiation therapy: A 2-year multicenter cohort study.

PURPOSE: Optically stimulated luminescent dosimeters (OSLDs) are utilized for in vivo dosimetry (IVD) of modern radiation therapy techniques such as intensity modulated radiation therapy (IMRT) and volumetric modulated arc therapy (VMAT). Dosimetric precision achieved with conventional techniques may not be attainable. In this work, we measured accuracy and precision for a large sample of clinical OSLD-based IVD measurements. METHODS AND MATERIALS: Weekly IVD measurements were collected from 4 linear accelerators for 2 years and were expressed as percent differences from planned doses. After outlier analysis, 10,224 measurements were grouped in the following way: overall, modality (photons, electrons), treatment technique (3-dimensional [3D] conformal, field-in-field intensity modulation, inverse-planned IMRT, and VMAT), placement location (gantry angle, cardinality, and central axis positioning), and anatomical site (prostate, breast, head and neck, pelvis, lung, rectum and anus, brain, abdomen, esophagus, and bladder). Distributions were modeled via a Gaussian function. Fitting was performed with least squares, and goodness-of-fit was assessed with the coefficient of determination. Model means (µ) and standard deviations (σ) were calculated. Sample means and variances were compared for statistical significance by analysis of variance and the Levene tests (α = 0.05). RESULTS: Overall, µ ± σ was 0.3 ± 10.3%. Precision for electron measurements (6.9%) was significantly better than for photons (10.5%). Precision varied significantly among treatment techniques (P < .0001) with field-in-field lowest (σ = 7.2%) and IMRT and VMAT highest (σ = 11.9% and 13.4%, respectively). Treatment site models with goodness-of-fit greater than 0.90 (6 of 10) yielded accuracy within ±3%, except for head and neck (µ = -3.7%). Precision varied with treatment site (range, 7.3%-13.0%), with breast and head and neck yielding the best and worst precision, respectively. Placement on the central axis of cardinal gantry angles yielded more precise results (σ = 8.5%) compared with other locations (range, 10.5%-11.4%). CONCLUSIONS: Accuracy of ±3% was achievable. Precision ranged from 6.9% to 13.4% depending on modality, technique, and treatment site. Simple, standardized locations may improve IVD precision. These findings may aid development of patient-specific tolerances for OSLD-based IVD.

Deformable image registration and interobserver variation in contour propagation for radiation therapy planning.

Deformable image registration (DIR) and interobserver variation inevitably intro-duce uncertainty into the treatment planning process. The purpose of the current work was to measure deformable image registration (DIR) errors and interobserver variability for regions of interest (ROIs) in the head and neck and pelvic regions. Measured uncertainties were combined to examine planning margin adequacy for contours propagated for adaptive therapy and to assess the trade-off of DIR and interobserver uncertainty in atlas-based automatic segmentation. Two experi-enced dosimetrists retrospectively contoured brainstem, spinal cord, anterior oral cavity, larynx, right and left parotids, optic nerves, and eyes on the planning CT (CT1) and attenuation-correction CT of diagnostic PET/CT (CT2) for 30 patients who received radiation therapy for head and neck cancer. Two senior radiation oncology residents retrospectively contoured prostate, bladder, and rectum on the postseed-implant CT (CT1) and planning CT (CT2) for 20 patients who received radiation therapy for prostate cancer. Interobserver variation was measured by calculating mean Hausdorff distances between the two observers' contours. CT2 was deformably registered to CT1 via commercially available multipass B-spline DIR. CT2 contours were propagated and compared with CT1 contours via mean Hausdorff distances. These values were summed in quadrature with interobserver variation for margin analysis and compared with interobserver variation for sta-tistical significance using two-tailed t-tests for independent samples (α = 0.05). Combined uncertainty ranged from 1.5-5.8 mm for head and neck structures and 3.1-3.7 mm for pelvic structures. Conventional 5 mm margins may not be adequate to cover this additional uncertainty. DIR uncertainty was significantly less than interobserver variation for four head and neck and one pelvic ROI. DIR uncertainty was not significantly different than interobserver variation for four head and neck and one pelvic ROI. DIR uncertainty was significantly greater than interobserver variation for two head and neck and one pelvic ROI. The introduction of DIR errors may offset any reduction in interobserver variation by using atlas-based automatic segmentation.

Prospective contouring rounds: A novel, high-impact tool for optimizing quality assurance.

PURPOSE: This study was designed to present the results of a novel prospective contouring rounds (CR), in which peer review occurs once the contours and written directive are completed but before initiation of treatment planning. METHODS AND MATERIALS: Beginning in 2012, all patients undergoing conventionally fractionated radiation therapy at a high-volume academic center were reviewed in a newly initiated daily, prospective, multidisciplinary CR. Cases were scheduled for presentation 2 days after simulation with the expectation that contours would be complete. The clinical suitability of the clinical plan, prescription, contours, and written directive were evaluated and recorded in a prospective database. Treatment planning did not commence until CR approval. Patient information and the prospective database from the first 6 months since program inception, which represented 581 consecutive treatment plans, were pooled and analyzed retrospectively to determine the impact of the prospective peer review at this stage of care delivery. RESULTS: Sixty-four percent of cases were completed on time without correction. The remaining 36% of cases required modification before treatment planning was initiated. Incomplete contours, target-volume modifications, and alterations to the written directive were the most common corrections or reasons for delay. Decreasing rates of incomplete contours, contour modifications, and miscellaneous delays were seen over time as the program became established. The percentage of cases that had no delays or modifications increased continuously as the program matured in the first 6 months, from 59% to 70%. CONCLUSIONS: Prospective CR is a meaningful and impactful tool in the quality assurance process. More than one-third of cases required contour, directive, or scheduling modification. The establishment of CR improved quality of care, with the percentage of timely, errorless cases increasing steadily over time. The impact of clinical peer review may be optimized by implementation at this early stage of delivery of care rather than at the time of traditional chart rounds.

Development, implementation, and compliance of treatment pathways in radiation medicine.

INTRODUCTION: While much emphasis on safety in the radiation oncology clinic is placed on process, there remains considerable opportunity to increase safety, enhance outcomes, and avoid ad hoc care by instituting detailed treatment pathways. The purpose of this study was to review the process of developing evidence and consensus-based, outcomes-oriented treatment pathways that standardize treatment and patient management in a large multi-center radiation oncology practice. Further, we reviewed our compliance in incorporating these directives into our day-to-day clinical practice. METHODS: Using the Institute of Medicine guideline for developing treatment pathways, 87 disease specific pathways were developed and incorporated into the electronic medical system in our multi-facility radiation oncology department. Compliance in incorporating treatment pathways was assessed by mining our electronic medical records (EMR) data from January 1, 2010 through February 2012 for patients with breast and prostate cancer. RESULTS: This retrospective analysis of data from EMR found overall compliance to breast and prostate cancer treatment pathways to be 97 and 99%, respectively. The reason for non-compliance proved to be either a failure to complete the prescribed care based on grade II or III toxicity (n = 1 breast, 3 prostate) or patient elected discontinuance of care (n = 1 prostate) or the physician chose a higher dose for positive/close margins (n = 3 breast). CONCLUSION: This study demonstrates that consensus and evidence-based treatment pathways can be developed and implemented in a multi-center department of radiation oncology. And that for prostate and breast cancer there was a high degree of compliance using these directives. The development and implementation of these pathways serve as a key component of our safety program, most notably in our effort to facilitate consistent decision-making and reducing variation between physicians.

Incident Learning and Failure-Mode-and-Effects-Analysis Guided Safety Initiatives in Radiation Medicine.

By combining incident learning and process failure-mode-and-effects-analysis (FMEA) in a structure-process-outcome framework we have created a risk profile for our radiation medicine practice and implemented evidence-based risk-mitigation initiatives focused on patient safety. Based on reactive reviews of incidents reported in our departmental incident-reporting system and proactive FMEA, high safety-risk procedures in our paperless radiation medicine process and latent risk factors were identified. Six initiatives aimed at the mitigation of associated severity, likelihood-of-occurrence, and detectability risks were implemented. These were the standardization of care pathways and toxicity grading, pre-treatment-planning peer review, a policy to thwart delay-rushed processes, an electronic whiteboard to enhance coordination, and the use of six sigma metrics to monitor operational efficiencies. The effectiveness of these initiatives over a 3-years period was assessed using process and outcome specific metrics within the framework of the department structure. There has been a 47% increase in incident-reporting, with no increase in adverse events. Care pathways have been used with greater than 97% clinical compliance rate. The implementation of peer review prior to treatment-planning and use of the whiteboard have provided opportunities for proactive detection and correction of errors. There has been a twofold drop in the occurrence of high-risk procedural delays. Patient treatment start delays are routinely enforced on cases that would have historically been rushed. Z-scores for high-risk procedures have steadily improved from 1.78 to 2.35. The initiatives resulted in sustained reductions of failure-mode risks as measured by a set of evidence-based metrics over a 3-years period. These augment or incorporate many of the published recommendations for patient safety in radiation medicine by translating them to clinical practice.

Implementation of a "No Fly" safety culture in a multicenter radiation medicine department.

PURPOSE: The safe delivery of radiation therapy requires multiple disciplines and interactions to perform flawlessly for each patient. Because treatment is individualized and every aspect of the patient's care is unique, it is difficult to regiment a delivery process that works flawlessly. The purpose of this study is to describe one safety-directed component of our quality program called the "No Fly Policy" (NFP). METHODS AND MATERIALS: Our quality assurance program for radiation therapy reviewed the entire process of care prior, during, and after a patient's treatment course. Each component of care was broken down and rebuilt within a matrix of multidisciplinary safety quality checklists (QCL). The QCL process map was subsequently streamlined with revised task due dates and stopping rules. The NFP was introduced to place a holding pattern on treatment initiation pending reconciliation of associated stopping events. The NFP was introduced in a pilot phase using a Six-Sigma process improvement approach. Quantitative analysis on the performance of the new QCLs was performed using crystal reports in the Oncology Information Systems. Root cause analysis was conducted. RESULTS: Notable improvements in QCL performance were observed. The variances among staff in completing tasks reduced by a factor of at least 3, suggesting better process control. Steady improvements over time indicated an increasingly compliant and controlled adoption of the new safety-oriented process map. Stopping events led to rescheduling treatments with average and maximum delays of 2 and 4 days, respectively, with no reported adverse effects. The majority of stopping events were due to incomplete plan approvals stemming from treatment planning delays. Whereas these may have previously solicited last-minute interventions, including intensity modulated radiation therapy quality assurance, the NFP enabled nonpunitive, reasonable schedule adjustments to mitigate compromises in safe delivery. CONCLUSIONS: Implementation of the NFP has helped to mitigate risk from expedited care, convert reactive to proactive delays, and created a checklist, process driven, and variance-reducing culture in a large, multicenter department.

Six sigma tools for a patient safety-oriented, quality-checklist driven radiation medicine department.

INTRODUCTION: The purpose of this work was to develop and implement six sigma practices toward the enhancement of patient safety in an electronic, quality checklist-driven, multicenter, paperless radiation medicine department. METHODS AND MATERIALS: A quality checklist process map (QPM), stratified into consultation through treatment-completion stages was incorporated into an oncology information systems platform. A cross-functional quality management team conducted quality-function-deployment and define-measure-analyze-improve-control (DMAIC) six sigma exercises with a focus on patient safety. QPM procedures were Pareto-sorted in order of decreasing patient safety risk with failure mode and effects analysis (FMEA). Quantitative metrics for a grouped set of highest risk procedures were established. These included procedural delays, associated standard deviations and six sigma Z scores. Baseline performance of the QPM was established over the previous year of usage. Data-driven analysis led to simplification, standardization, and refinement of the QPM with standard deviation, slip-day reduction, and Z-score enhancement goals. A no-fly policy (NFP) for patient safety was introduced at the improve-control DMAIC phase, with a process map interlock imposed on treatment initiation in the event of FMEA-identified high-risk tasks being delayed or not completed. The NFP was introduced in a pilot phase with specific stopping rules and the same metrics used for performance assessments. A custom root-cause analysis database was deployed to monitor patient safety events. RESULTS: Relative to the baseline period, average slip days and standard deviations for the risk-enhanced QPM procedures improved by over threefold factors in the NFP period. The Z scores improved by approximately 20%. A trend for proactive delays instead of reactive hard stops was observed with no adverse effects of the NFP. The number of computed potential no-fly delays per month dropped from 60 to 20 over a total of 520 cases. The fraction of computed potential no-fly cases that were delayed in NFP compliance rose from 28% to 45%. Proactive delays rose to 80% of all delayed cases. For potential no-fly cases, event reporting rose from 18% to 50%, while for actually delayed cases, event reporting rose from 65% to 100%. CONCLUSIONS: With complex technologies, resource-compromised staff, and pressures to hasten treatment initiation, the use of the six sigma driven process interlocks may mitigate potential patient safety risks as demonstrated in this study.

Evaluating thin compression paddles for mammographically compatible ultrasound.

We are developing a combined digital mammography/3D ultrasound system to improve detection and/or characterization of breast lesions. Ultrasound scanning through a mammographic paddle could significantly reduce signal level, degrade beam focusing and create reverberations. Thus, appropriate paddle choice is essential for accurate sonographic lesion detection and assessment with this system. In this study, we characterized ultrasound image quality through paddles of varying materials (lexan, polyurethane, TPX, mylar) and thicknesses (0.25 to 2.5 mm). Analytical experiments focused on lexan and TPX, which preliminary results demonstrated were most competitive. Spatial and contrast resolution, side-lobe and range lobe levels, contrast and signal strength were compared with no-paddle images. When the beamforming of the system was corrected to account for imaging through the paddle, the TPX 2.5 mm paddle performed the best. Test objects imaged through this paddle demonstrated < or = 15% reduction in spatial resolution, < or = 7.5 dB signal loss, < or = 3 dB contrast loss and range lobe levels > or = 35 dB below signal maximum over 4 cm. TPX paddles <2.5 mm could also be used with this system, depending on imaging goals. In 10 human subjects with cysts, small CNR losses were observed but were determined to be statistically insignificant. Radiologists concluded that 75% of cysts in through-paddle scans were at least as detectable as in their corresponding direct-contact scans.

Combination of digital mammography with semi-automated 3D breast ultrasound.

This paper describes work aimed at combining 3D ultrasound with full-field digital mammography via a semi-automatic prototype ultrasound scanning mechanism attached to the digital mammography system gantry. Initial efforts to obtain high x-ray and ultrasound image quality through a compression paddle are proving successful. Registration between the x-ray mammogram and ultrasound image volumes is quite promising when the breast is stably compressed. This prototype system takes advantage of many synergies between the co-registered digital mammography and pulse-echo ultrasound image data used for breast cancer detection and diagnosis. In addition, innovative combinations of advanced US and X-ray applications are being implemented and tested along with the basic modes. The basic and advanced applications are those that should provide relatively independent information about the breast tissues. Advanced applications include x-ray tomosynthesis, for 3D delineation of mammographic structures, and non-linear elasticity and 3D color flow imaging by ultrasound, for mechanical and physiological information unavailable from conventional, non-contrast x-ray and ultrasound imaging.