Quality Assurance Review Research Articles

Australasian brachytherapy audit: Results of the ‘end‐to‐end’ dosimetry pilot study

We present the results of a pilot study to test the feasibility of a brachytherapy dosimetry audit. The feasibility study was conducted at seven sites from four Australian states in both public and private centres. A purpose-built cylindrical water phantom was imaged using the local imaging protocol and a treatment plan was generated to deliver 1 Gy to the central (1 of 3) thermoluminescent dosimeter (TLD) from six dwell positions. All centres completed the audit, consisting of three consecutive irradiations, within a 2-h time period, with the exception of one centre that uses a pulsed dose rate brachytherapy unit. All TLD results were within 4.5% of the predicted value, with the exception of one subset where the dwell position step size was incorrectly applied. While the limited data collected in the study demonstrated considerable heterogeneity in clinical practice, the study proved a brachytherapy dosimetry audit to be feasible. Future studies should include verification of source strength using a Standard Dosimetry Laboratory calibrated chamber, a phantom that more closely mimics the clinical situation, a more comprehensive review of safety and quality assurance (QA) procedures including source dwell time and position accuracy, and a review of patient treatment QA procedures such as applicator position verification.

Transition to a novel advanced integrated vitrectomy platform: comparison of the surgical impact of moving from the Accurus vitrectomy platform to the Constellation Vision System for microincisional vitrectomy surgery

BackgroundMicroincisional vitrectomy surgery (MIVS) is the current standard surgical approach for pars plana vitrectomy. Historically, the most common surgical platform for vitrectomy surgery, since its introduction in 1997, has been the Accurus vitrectomy system. Recent introduction of the next generation of vitrectomy platforms has generated concerns associated with transitioning to new technology in the operating room environment. This study compared, in a matched fashion, surgical use of the Accurus vitrectomy system and the next generation Constellation Vision System to evaluate surgical efficiencies, complications, and user perceptions of this transition.MethodsElectronic health records were abstracted as a hospital quality assurance activity and included all vitreoretinal surgical procedures at the Bascom Palmer Eye Institute, Anne Bates Leach Eye Hospital, during two discrete 12-month time periods. These two periods reflected dedicated usage of the Accurus (June 2008–May 2009) and Constellation Vision (July 2009–June 2010) systems. Data were limited to a single surgeon and evaluated for operating room (OR) total time usage/day, OR case time/case, and OR surgical time/case. Further analysis evaluated all patients undergoing combined MIVS and clear cornea phacoemulsification/intraocular lens (IOL) implantation during each individual time period to determine the impact of the instrumentation on these parameters. All records were evaluated for intraoperative complications.ResultsFive hundred and fourteen eligible patients underwent MIVS during the 2-year study windows, with 281 patients undergoing surgery with the Accurus system and 233 patients undergoing surgery with the Constellation system. Combined MIVS and phacoemulsification with IOL implantation was performed 141 times during this period with the Accurus and 158 times during the second study period with the Constellation. Total number of patients operated per day increased from 7.55 with Accurus to 8.53 with Constellation. Surgical room time decreased from 56 minutes with Accurus to 52 minutes with Constellation, and procedure time decreased from 35 minutes with Accurus to 31 minutes with Constellation (P < 0.004). Combined MIVS/phacoemulsification surgery saw similar declines in surgical room time and procedure time (P < 0.001). Subset analysis of procedures limited by case number per day (eg, four cases/day, five cases/day, six cases/day, and seven or more cases/day) showed similar outcomes with a decrease in surgical room time and procedure time. No increases in surgery-related complications were noted by quality assurance review during these time periods.Discussion:Transitioning to advanced surgical technology is a complex issue for the surgeon, the hospital team, and the hospital administration. This study documents improvement in three significant measures of surgical efficiency: operative number of patients per day, operative room time, and surgical procedure time that reflect the positive impact of the novel, combined, integrated, posterior and anterior, ophthalmologic surgical platform of the Constellation Vision System. These data are imperative to evaluate the impact of transition from one surgical platform to another. During this transition, hospital quality assurance review and surgeon evaluation of operative complications showed no increased concerns for the shift from the Accurus to the Constellation Vision System surgical platform. Further, both operative staff and surgeons felt that the transition to the Constellation was not associated with increases in difficulty with setup, turnover, or use and that the Constellation decreased safety concerns for surgical usage. Ultimately, in this case, new technology benefited the surgeon, the patient, and the hospital.

Quality Assurance in Psychology Programmes across Europe: Survey and Reflections

The present article examines how different institutions that offer psychology study cycles across Europe have adopted quality principles and have taken up particular quality assurance initiatives to raise standards and enhance quality. Thirty-eight different institutions from 32 countries who were members of a European psychology network responded to a survey about quality issues. Results are presented regarding (a) policy and procedures for quality assurance, (b) approval, monitoring and periodic review of programmes and awards, (c) assessment of students, and (d) quality assurance of teaching staff. Implications for the quality assurance of psychology programmes and for further studies are discussed.

Why are common quality and development policies needed?

The EMI project is based on the collaboration of four major middleware projects in Europe, all already developing middleware products and having their pre-existing strategies for developing, releasing and controlling their software artefacts. In total, the EMI project is made up of about thirty development individual teams, called “Product Teams” in EMI. A Product Team is responsible for the entire lifecycle of specific products or small groups of tightly coupled products, including the development of test-suites to be peer reviewed within the overall certification process. The Quality Assurance in EMI (European Middleware Initiative), as requested by the grid infrastructures and the EU funding agency, must support the teams in providing uniform releases and interoperable middleware distributions, with a common degree of verification and validation of the software and with metrics and objective criteria to compare product quality and evolution over time. In order to achieve these goals, the QA team in EMI has defined and now it monitors the development work and release with a set of comprehensive policies covering all aspects of a software project such as packaging, configuration, documentation, certification, release management and testing. This contribution will present with practical and useful examples the achievements, problems encountered and lessons learned in the definition, implementation and review of Quality Assurance and Development policies. It also describes how these policies have been implemented in the EMI project including the benefits and difficulties encountered by the developers in the project. The main value of this contribution is that all the policies explained are not depending on EMI or grid environments and can be used by any software project.

The emergence of private higher education in Australia: the silent provider

For many years, the university sector has been the dominant provider of higher education in Australia. However, recent changes in government policy which have broadened access to publicly-funded subsidised student loans have resulted in the emergence of small and large private higher education providers and consortiums offering English language, vocational and higher education courses. This new entrant into the higher education sector has experienced consistent growth of more than 20% in the years 2007–2009, with predictions of ongoing expansion in coming years. This article is based on the perceptions and experiences in undertaking quality assurance reviews in three diverse private provider institutions offering both vocational and higher education courses in Australia. The reviews focused on the provision of higher education programs and the authors are of the view that private higher education providers have played a key role in diversifying participation in higher education in Australia. Specifically, they have opened up access, opportunity and pathways for many students who previously may not have pursued higher education studies. The authors characterise this new entrant as the ‘silent provider’, because it has largely been ignored by the academy. The jury is still out on whether this oversight will present significant competition and threat to universities, which have traditionally enjoyed a monopoly in higher education. While reviewing the private providers the authors were heartened by the evidence of outstanding learning and teaching taking place within the institutions. While improvements need to be made in terms of developing systematic quality assurance processes and embedding professional development for staff, the reviewers found the private providers to be worthy participants in the sector. They recommend that rather than seeing the private providers as competitors, university leaders need to find ways to collaborate with private providers by initially focusing on the learner and their needs.

A Province-wide Quality Assurance (QA) Review of Stereotactic Body Radiation Therapy (SBRT) Treatment Planning for Lung Cancer

A Province-wide Quality Assurance (QA) Review of Stereotactic Body Radiation Therapy (SBRT) Treatment Planning for Lung Cancer

Radiation Therapy Quality Assurance on AHOD0031: A Report From the Quality Assurance Review Center (QARC) and the Children's Oncology Group

AHOD0031, a phase III trial assessing response-based therapy in intermediate-risk Hodgkin lymphoma, mandated central review of all radiation therapy (RT) and imaging records by QARC to maximize compliance with treatment and response evaluation guidelines. We report the impact of systematic RT data review on protocol compliance.

Real-time Peer Review Quality Assurance Conferences Incorporating Physical Examination for Head-and-Neck Cancer Radiation Therapy Result in Clinically Meaningful Target Volume Alteration: Results of a Prospective Volumetric Analysis

Our institution has a long-established comprehensive quality assurance conference (QAC) for pts undergoing radiation (RT) for head and neck cancer (HNC). QAC includes physical examination (PE), review of diagnostic imaging (DI), pathology, and real-time review of clinical target volume (CTV) and organ-at-risk (OAR) contours with consensus approval by multiple attendings specializing in HNC before dosimetric planning commences. We showed previously that PE was the most important factor leading to change.

Quality assurance and quality control practices for rehabilitation of sewer and water mains

As part of the US Environmental Protection Agency (EPA)'s Aging Water Infrastructure Research Program, several areas of research are being pursued including a review of quality assurance and quality control (QA/QC) practices and acceptance testing during the installation of rehabilitation systems (USEPA 2011). The objectives of this research effort were to collect, analyze and summarize information on the installation and QA/QC practices for the trenchless rehabilitation of sewer and water transmission mains. In addition, consideration was given to practices related to water service lines, sewer service laterals, force mains, siphons, sewer manholes, pumping stations, associated wet wells and other appurtenances. This review was accomplished primarily by conducting interviews directly with rehabilitation technology vendors, design engineers and water and wastewater utilities that have a track record of using trenchless rehabilitation technologies within their network. This paper provides an overview of how QA/QC issues have been handled in North America for trenchless rehabilitation technologies.

PS1-40: The VDW Vital Signs File: 2011 Quality Assurance Activities

Background/Aims The VDW Vitals Workgroup specifies data standards for the four traditional clinical vital signs (body temperature, blood pressure, respirations, heart rate) and other physiological measures that are collected routinely during clinic visits, such as height and weight. Data specifications changed considerably between the older Version 2, and the current Version 3. The Vitals Workgroup recently completed quality assurance review of the vital signs data from the sites participating in the VDW. The aim of this review is to ensure that sites have standardized their data tables according to Workgroup Version 3 specifications, data are within plausible ranges, and to assess the abundance of data.

Results of a Quality Assurance Review of External Beam Radiation Therapy in the International Society of Paediatric Oncology (Europe) Neuroblastoma Group's High-risk Neuroblastoma Trial: A SIOPEN Study

Radiation therapy is important for local control in neuroblastoma. This study reviewed the compliance of plans with the radiation therapy guidelines of the International Society of Paediatric Oncology (Europe) Neuroblastoma Group (SIOPEN) High-Risk Trial protocol. The SIOPEN trial central electronic database has sections to record diagnostic imaging and radiation therapy planning data. Individual centers may upload data remotely, but not all centers involved in the trial chose to use this system. A quality scoring system was devised based on how well the radiation therapy plan matched the protocol guidelines, to what extent deviations were justified, and whether adverse effects may result. Central review of radiation therapy planning was undertaken retrospectively in 100 patients for whom complete diagnostic and treatment sets were available. Data were reviewed and compared against protocol guidelines by an international team of radiation oncologists and radiologists. For each patient in the sample, the central review team assigned a quality assurance score. It was found that in 48% of patients there was full compliance with protocol requirements. In 29%, there were deviations for justifiable reasons with no likely long-term adverse effects resulting. In 5%, deviations had occurred for justifiable reasons, but that might result in adverse effects. In 1%, there was a deviation with no discernible justification, which would not lead to long-term adverse events. In 17%, unjustified deviations were noted, with a risk of an adverse outcome resulting. Owing to concern over the proportion of patients in whom unjustified deviations were observed, a protocol amendment has been issued. This offers the opportunity for central review of radiation therapy plans before the start of treatment and the treating clinician a chance to modify plans.

Does Body Mass Index Impact the Performance of Robot-Assisted Intracorporeal Ileal Conduit?

Body mass index (BMI) has been shown to influence perioperative outcomes for patients undergoing open radical cystectomy and urinary diversion. The impact of BMI on robot-assisted intracorporeal ileal conduit has not been studied. All patients undergoing robot-assisted radical cystectomy (RARC) with ileal conduit at our institution were offered intracorporeal ileal conduit beginning May 2009. Fifty-six consecutive patients underwent robot-assisted radical cystectomy with intracorporeal ileal conduit from May of 2009 to July 2010. Patients were categorized into three groups based on BMI: Normal (BMI < 25 kg/m(2)), overweight (BMI=25-29 kg/m(2)), and obese (BMI ≥ 30 kg/m(2)). The effect of BMI on intraoperative and postoperative outcomes was assessed by retrospective review of a comprehensive RARC quality assurance database. Median age at cystectomy was 72 (range 42-87 y), and 75% of patients were male. Median follow-up for the entire cohort was 5 months (range 12 d-16 mos). Median BMI was 27 kg/m(2) (range 19-47 kg/m(2)), and 75% of patients were overweight or obese. Age, ASA score, and overall operative time were not significantly different among the normal, overweight, and obese patients. Median urinary diversion times were 95, 151, and 124 minutes for normal, overweight, and obese patients, respectively (P=0.13). Robot-assisted intracorporeal ileal conduit can be safely performed in all body mass indices. Further studies are needed to assess long-term conduit function and stomal complications.

ST03: A randomized trial of perioperative epirubicin, cisplatin plus capecitabine (ECX) with or without bevacizumab (B) in patients (pts) with operable gastric, oesophagogastric junction (OGJ) or lower oesophageal adenocarcinoma.

TPS4143 Background: Perioperative ECX chemotherapy is a standard of care for localised gastric/OGJ/lower oesophageal adenocarcinoma (Cunningham NEJM 2006). B is a monoclonal antibody targeting VEGF-A, and in combination with chemotherapy results in improved response rates (RR) and progression free survival in advanced gastric cancer (Ohtsu JCO 2011). The aim of ST03 is to assess the safety and feasibility (stage I, first 200 pts) and efficacy (stage II) of the addition of B to perioperative ECX chemotherapy. Methods: ST03 is a multicentre, open-label, phase II/III randomised trial ongoing at 92 UK centres; sites in Germany will open in 2012. Eligibility criteria are histologically proven, untreated, resectable, lower oesophageal, OGJ or gastric adenocarcinoma; age ≥18 years; WHO PS 0-1; and adequate cardiac ejection fraction (EF). Exclusion criteria are TIA/CVA or MI ≤1 year; uncontrolled hypertension; ≥Grade II NYHA heart failure; recent gastrointestinal inflammatory conditions or major surgery/trauma/open biopsy &lt;28d of study entry. Pts receive 3 pre- and 3 postoperative ECX (epirubicin 50 mg/m2 iv D1, cisplatin 60 mg/m2 iv D1 and capecitabine 1250mg/m2/D1-21) +/- B 7.5mg/kg D1 q3wk during chemotherapy, then 6 Bev q3wk (investigational arm). Surgery is pre-specified and laparoscopic procedures allowed only after quality assurance review. All specimens undergo central pathology review; blood and tissue collection for translational correlates is ongoing. The primary outcome measures for Stage I (safety results including cardiac EF) have been reported (Okines ASCO 2011). The stage II primary outcome measure is overall survival. Secondary outcome measures are RR, resection rate, disease free survival, toxicity, and QoL. An MRI substudy is open, a PET substudy is planned. 558 of ~950 pts required have been recruited, accrual expected to complete in 2013. An embedded pilot study within ST03 randomising HER2 positive patients to ECX ± lapatanib will open in 2012. Trial sponsored and co-ordinated by the MRC Clinical Trials Unit and funded by Cancer Research UK (CRUK06/025, NCT00450203).

2012 American college of cardiology foundation/society for cardiovascular angiography and interventions expert consensus document on cardiac catheterization laboratory standards update: American college of cardiology foundation task force on expert consensus documents society of thoracic surgeons society for vascular medicine

2012 American college of cardiology foundation/society for cardiovascular angiography and interventions expert consensus document on cardiac catheterization laboratory standards update: American college of cardiology foundation task force on expert consensus documents society of thoracic surgeons society for vascular medicine

Quality assurance for image‐guided radiation therapy utilizing CT‐based technologies: A report of the AAPM TG‐179

Commercial CT-based image-guided radiotherapy (IGRT) systems allow widespread management of geometric variations in patient setup and internal organ motion. This document provides consensus recommendations for quality assurance protocols that ensure patient safety and patient treatment fidelity for such systems. The AAPM TG-179 reviews clinical implementation and quality assurance aspects for commercially available CT-based IGRT, each with their unique capabilities and underlying physics. The systems described are kilovolt and megavolt cone-beam CT, fan-beam MVCT, and CT-on-rails. A summary of the literature describing current clinical usage is also provided. This report proposes a generic quality assurance program for CT-based IGRT systems in an effort to provide a vendor-independent program for clinical users. Published data from long-term, repeated quality control tests form the basis of the proposed test frequencies and tolerances. A program for quality control of CT-based image-guidance systems has been produced, with focus on geometry, image quality, image dose, system operation, and safety. Agreement and clarification with respect to reports from the AAPM TG-101, TG-104, TG-142, and TG-148 has been addressed.

Multidisciplinary breast centres in Germany: a review and update of quality assurance through benchmarking and certification

PurposeThis review summarizes the rationale for the creation of breast centres and discusses the studies conducted in Germany to obtain proof of principle for a voluntary, external benchmarking programme and proof of concept for third-party dual certification of breast centres and their mandatory quality management systems to the German Cancer Society (DKG) and German Society of Senology (DGS) Requirements of Breast Centres and ISO 9001 or similar. In addition, we report the most recent data on benchmarking and certification of breast centres in Germany.MethodsReview and summary of pertinent publications. Literature searches to identify additional relevant studies. Updates from the DKG/DGS programmes.Results and conclusionsImprovements in surrogate parameters as represented by structural and process quality indicators suggest that outcome quality is improving. The voluntary benchmarking programme has gained wide acceptance among DKG/DGS-certified breast centres. This is evidenced by early results from one of the largest studies in multidisciplinary cancer services research, initiated by the DKG and DGS to implement certified breast centres. The goal of establishing a nationwide network of certified breast centres in Germany can be considered largely achieved. Nonetheless the network still needs to be improved, and there is potential for optimization along the chain of care from mammography screening, interventional diagnosis and treatment through to follow-up. Specialization, guideline-concordant procedures as well as certification and recertification of breast centres remain essential to achieve further improvements in quality of breast cancer care and to stabilize and enhance the nationwide provision of high-quality breast cancer care.

Identification of Cancer Patients with Lynch Syndrome: Clinically Significant Discordances and Problems in Tissue-Based Mismatch Repair Testing

Tissue-based microsatellite instability (MSI) analysis and immunohistochemistry for DNA mismatch repair proteins are accepted screening tools to evaluate patients with cancer for Lynch syndrome. These laboratory analyses are thus important tools in cancer prevention. Quality assurance review was conducted to identify test discordances and problems. These results were then analyzed in conjunction with genetic testing outcomes. Six hundred and forty-six consecutive tumors from 2002 to 2010 were examined. MSI-low tumors were excluded so that 591 tumors comprised the final analyses. Discordance was defined as a discrepancy between immunohistochemical and MSI analysis. Problem was defined as indeterminate or questionable immunohistochemical or MSI results. All results and clinical and family histories were centrally reviewed by two pathologists and one genetics counselor. Discordances and problems were identified in 23 of 591 (3.9%) of the tumors. Twelve of 102 MSI-high carcinomas (11.8%) and one of 489 microsatellite stable tumors had discordant immunohistochemistry. Of these 13 tumors, 11 were from patients who had personal and/or family cancer histories concerning for a germline mismatch repair gene mutation. In addition to discordances, 10 tumors with problematic immunohistochemical profiles were identified. Accurate evaluation of MSI was possible in all tumors. In summary, concordance between immunohistochemistry and MSI was high, particularly for tumors that are microsatellite stable. Greater frequency of test discordance was identified in the tumors that were MSI-high. Thus, a major consequence of the use of immunohistochemistry by itself as a screen is the failure to identify colorectal and endometrial cancer patients who likely have Lynch syndrome.

品質保証（信頼性保証）と適合性調査

品質保証（信頼性保証）と適合性調査

P4-09-22: Multicenter Quality Assurance Profile Review of Lobular Breast Carcinomas Versus the 21 Gene Recurrence Score: Assessment of Clinical Relevance.

Abstract Introduction The oncotype dx (ODX) 21 gene recurrence score (RS), was intended to predict the 10 year risk of breast cancer recurrence for estrogen receptor positive, lymph node negative disease (NEJM 2004;351:2817–26). The proportions of patients that were reported as low, intermediate and high risk were 51%/22%, 27%. This population of patients was dominated by ductal carcinomas (DCA), with a paucity of classical lobular carcinomas (CLCA), which are ER-rich and low grade histology. To date, there is dearth of data regarding the relationship of the RS and CLCA, and the clinical relevance regarding the ODX RS in CLCA has not been studied. Methods As part of quality assurance review at three institutions, the ODX RS for all CLCA were reviewed in order to determine the perceived clinical relevance of the ODX RS compared to the proportions of RS reported (NEJM 2004;351:2817–26). Results A total of 219 cases of ODX were performed on CLCA. The low/intermediate/high risk profile was 58%/40%/2%. Conclusions (1) The risk profile of ODX for CLCA is very different from the original DCA dominant population previously reported. (2) If the goal of ODX is to identify candidates for chemotherapy, then a high RS is a rare event for CLCA, and as such, the judgment to administer chemotherapy to an individual patient would most likely depend upon factors other than the ODX, because 98 percent of patients are combined low/intermediate risk RS. Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr P4-09-22.

Extraneous Tissue

"Floaters" represent a potential cause of diagnostic error and may arise during tissue processing and slide preparation. Our objective was to determine the frequency of floaters in slides and features useful in their recognition. We reviewed quality assurance (QA) records for floaters in slides and prospectively examined 1,000 additional slides for floaters and documented floater size, location, and presence in 1 or more sections. In the 521,661 slides reviewed for QA, 65 floaters were detected: 28 were present in the tissue block, and 37 were found only in a single level. In the 1,000 prospectively examined slides, 12 floaters were detected; 9 were only in a single section. Floaters represent a potential source of diagnostic error and occur in 0.01% to 1.2% of slides. Pick up of floaters from the water bath appears most common (∼60%). Floaters in only 1 level and mismatch with the specimen tissue type are clues to the extraneous nature of the floater.