Documentation Requirements Research Articles

Regulatory Requirements and Innovation: A Comparison of Stability Study in the United States Food and Drug Administration (USFDA) and the Gulf Cooperation Council (GCC)

Stability studies form a crucial aspect of the pharmaceutical development process and play a vital role in establishing the quality, safety and efficacy of the drug product. The core objective of a stability study is to ascertain the shelf-life of a drug product and to understand how best to design the drug product and its container-closure system so as to ensure that the same maintain suitable physical and chemical properties during the proposed shelf-life period. Since stability studies are inherently crucial to the lifecycle of a pharmaceutical formulation, the process and its requirements are subject to stringent regulations and specifications by regulatory authorities around the globe. A multitude of guidelines have been published in this regard by various regulatory authorities entailing concepts, techniques and protocols associated with stability testing, with the aim of aiding drug manufacturers generate accurate and viable stability data. Most of these guidelines, however, are based on the International Council for Harmonisation (ICH) stability guidelines and have been adapted by individual regulatory authorities to complement the climatic conditions of the respective regions, two such examples being the United States Food and Drug Administration (USFDA) and the Gulf Cooperation Council (GCC). Therefore, the present work aims to briefly discuss the stability guidelines applicable in each region and identify any similarities and differences, whilst examining the documentation requirements related to stability studies as well as the dossier requisites to be adhered to during drug product registrations.

Assessing burnout among oncologists in Ontario, Canada.

41 Background: Provider experience and physician burnout has been recognized as a critical issue in medicine. Ontario, Canada has a single payer cancer system run by Ontario Health (Cancer Care Ontario) with a mandate covering system level planning and delivery of cancer services, funding, and quality improvement. As part of a larger provincial initiative to address clinician burnout, we examined the prevalence and drivers of burnout in practicing physician oncologists in Ontario. Methods: In November-December 2019, surgical, medical, hematological, and radiation oncologists in Ontario were invited to complete an anonymous online survey to assess burnout and its drivers. Burnout prevalence was assessed through the Maslach Burnout Inventory – Human Services Survey for Medical Personnel (MBI-HSS MP). Data on demographic, workplace, engagement, and practice profiles were collected. Logistic regression modeling was conducted to assess key variables associated with “high” burnout using a common definition of high scores on the MBI subscales of emotional exhaustion (EE) (> 27) and/or depersonalization (DP) (>10). Results: Response rate to the survey was 44% (n=418) with 72% reporting high levels of burnout. Mean scores for EE (30.7, SD 12.1) and DP (9.9, SD 6.7) were consistent with high burnout. Participants endorsed known drivers of burnout including: 1) a poor culture of wellness at work (e.g., not comfortable talking to leadership (72%), 2) inefficiencies of practice (e.g. feeling insufficient documentation time (67%)) and 3) personal resilience (e.g. not feeling they are contributing professionally in ways they value (21%)). Age (<45yrs) (OR: 2.15), poor/marginal control over workload (OR: 4.42), feeling used/unappreciated (OR: 2.63), working atmosphere that feels hectic/chaotic (OR: 2.68), and insufficient time for documentation requirements (OR: 2.52) significantly impacted the odds of high burnout in the regression model (p<0.05). Conclusions: The high rate of burnout among oncology physicians in a single payer public cancer system in Ontario is concerning for the wellbeing of providers, patients and system sustainability. Drivers important for maintaining a culture of wellness and efficiency of practice will require local, regional and provincial health policy to improve. Next steps will include raising awareness with provincial initiatives/policy to address key burnout drivers, and examining the impact of working under pandemic conditions (Covid-19) on oncologist burnout.

Improving knowledge on vaccine storage management in general practices: Learning effectiveness of an online-based program

BackgroundAdequate vaccine storage is a prerequisite for assuring effective vaccinations yet storage conditions in practices are frequently inadequate. The online learning program Keep Cool aims at improving knowledge on international best practices. This study evaluates the program’s learning effectiveness focusing on key indicators for knowledge on vaccine storage, such as temperature target range (2 to 8 °C) and documentation requirements. MethodsParticipants were recruited from within a university teaching practice network. Knowledge was measured with an online-based questionnaire (11 correct items = optimal vaccine storage knowledge) which was completed before and after the online program. Results60 physicians and practice assistants from 25 practices participated. The mean knowledge score was 5.6 correct answers (standard deviation [SD] 1.9), which increased to 9.8 (SD 1.2) after program participation (p < 0.001). The item with the highest net change addressed the need for twice-daily documentation of temperatures (+76.7%). Knowledge of the lower and upper temperature targets improved from 58% respectively 63% to 100% each. Optimal vaccine storage knowledge after participation (38% of participants) was associated neither with age, gender, occupational group nor practice type. ConclusionThe new online education program showed a high learning effectiveness regarding key indicators for the quality of vaccine storage management.Clinical Trial Registry Number: DRKS00006561.

Analysis of challenges for automobile service garages in India: a structural modeling approach

PurposeThe increase in automobile usage across the world has fortified the opportunities of maintenance service garages. However, there are significant numbers of challenges in front of maintenance service providers at all stages of the business. This paper identifies, analyzes and prioritizes various challenges associated with the establishment and survival of garages specific to Indian context.Design/methodology/approachIn this paper, challenges for automotive service garage are identified through expert opinion, garage survey and literature. A structural hierarchical framework of the identified challenges is established through structural models, including interpretive structural modeling and analytic hierarchy process.FindingsThis paper has identified nine challenges, namely proliferation of new models and variants; technological advancements in automobile systems; demand of better service quality; space and ambience requirements; labor requirements; requirement of modern support equipments, tools and spares; safety requirements and prevention of occupational hazards; environmental norms and concerns; proper documentation requirements. The drivers and dependent variables have been identified. A hierarchical framework of challenges has been established.Practical implicationsThis paper provides a comprehensive list of challenges and their priority in establishing an automobile maintenance garage business in Indian context. This will help the budding entrepreneurs and existing maintenance organizations to focus on the challenges that necessitate immediate attention and corrective actions.Originality/valueThis paper provides a significant contribution in the literature of garage maintenance services, which is established on the viewpoint of different collaborators associated with this business. This study will be a foundation to investigate further in this domain.

Investor Perceptions of Government Deregulation: Evidence from Section 404 of the Sarbanes-Oxley Act

SYNOPSIS We investigate the stock market's reaction to events leading up to the Securities and Exchange Commission's and Public Company Accounting Oversight Board's 2007 regulatory changes that reduced the scope of and documentation requirements for assessments of firms' internal controls over financial reporting (ICFR), as required by the Sarbanes-Oxley Act, Section 404. We examine abnormal returns surrounding key dates leading to the passage of these regulations and offer two main findings. First, investors reacted negatively on key event dates, suggesting that investors viewed the regulations as likely to reduce financial reporting quality rather than to drive audit efficiencies. Second, this negative market reaction is larger when ICFR effectiveness should matter most—when firms are more complex, have higher litigation risk, and greater fraud risk. Overall, our results may imply that investors prefer stronger government regulation when it comes to the assessments of a firm's internal controls over financial reporting.

Taxpayer Non-Compliance with Input Tax Credit Rules: Data and Policy Options for Canada

Input tax credits (ITCs) are a mechanism for businesses to recover the goods and services tax (GST)/harmonized sales tax (HST) paid on expenses related to their commercial activities. While many businesses claim ITCs in accordance with the rules, instances of non-compliance are apparent. Canada uses an invoice credit system that relies on the claimant's retention of documentation that can be checked to detect any overstatement of ITC entitlement. Absent an audit, businesses are generally not required to provide tax authorities with details of their transactions. This article draws on a study of case law relating to section 169 of the Excise Tax Act over the five-year period 2014-2019. Section 169 contains the general principles and rules for claiming ITCs. The study highlights various reasons for non-compliance with the ITC system in Canada, both intentional and unintentional. There are several recurring themes: the prevalence of fraudulent practices in certain industries, burdensome documentation and verification requirements, and taxpayers' misunderstanding of the rules for claiming ITCs, owing to ambiguous or otherwise complicated legal tests. In particular, the substantive rules concerning what constitutes a "commercial activity" for the purposes of claiming ITCs are often misapplied or misunderstood by claimants. Undisclosed agency relationships also cause problems where they result in the wrong name appearing on the documentation supporting an ITC claim. These issues point to certain flaws in the implementation of the rules under the GST/HST regime in Canada. In response to instances of suspected fraud, Canadian tax authorities have been results-driven in implementing increasingly onerous supplier verification requirements that must be met before an ITC is claimed, particularly where the supplier did not remit the applicable tax. This contributes to a high compliance burden for taxpayers. Some proposals have been made for changes that would mitigate the issues associated with undisclosed agency relationships, but there are still problems with the documentation requirements and other substantive rules for claiming ITCs that need to be addressed. The article concludes with a review of reform options proposed or adopted in other jurisdictions with a value-added tax. It also discusses a compliance measure implemented in Quebec (the attestation de Revenu Québec), which could be applied in other provinces. Specific recommendations are made for the adoption of e-invoicing and increased reporting requirements to address some of the reasons for non-compliance in Canada. A number of countries have moved toward implementing periodic or near-real-time reporting requirements. These measures show promise and suggest that Canada could move in that direction as well.

Reduction of Central-Line–Associated Bloodstream Infections in a Spinal Cord Injury Unit

Background: Central-line–associated bloodstream infections (CLABSIs) are a complication of indwelling central venous catheters, which increase morbidity, mortality, and cost to patients. Objective: Due to increased rates in a spinal cord injury unit (SCIU), a performance improvement project was started to reduce CLABSI in the patient population. Methods: To reduce the incidence of CLABSI, a prevention bundle was adopted, and a peer-surveillance tool was developed to monitor compliance with the bundle. Staff were trained to monitor their peers and submit weekly surveillance. Audits were conducted by the clinical nurse leader with accuracy feedback. Bundle peer-surveillance was implemented in February of 2018 with data being fed back to leadership, peer monitors, and stakeholders. Gaps in compliance were addressed with peer-to-peer education, changes in documentation requirements, and meetings to improve communication and reduce line days. In addition, the use of an antiseptic-impregnated disc for vascular accesses was implemented for dressing changes. Further quality improvement cycles during the first 2 quarters of fiscal year 2019 included service-wide education reinforcement, identification in variance of practice, and reporting to staff and stakeholders. Results: CLABSI bundle compliance increased from 67% to 98% between February and October 2018. The weekly audit reporting accuracy improved from 33% to 100% during the same period. Bundle compliance was sustained through the fourth quarter of 2019 at 98%, and audit accuracy was 99%. The initial CLABSI rates the quarter prior to the intervention were 6.10 infections per 1,000 line days for 1 of the 3 SCIUs and 2.68 infections per 1,000 line days for the service overall. After the action plan was initiated, no CLABSIs occurred for the next 3 quarters in all SCIUs despite unchanged use of central lines (5,726 line days in 2018). The improvement was sustained, and the line days decreased slightly for 2019, with a fiscal year rate of 0.61 per 1,000 line days (ie, 3 CLABSIs in 4,927 central-line days). Conclusions: The incidence of CLABSI in the SCIU was reduced by an intensive surveillance intervention to perform accurate peer monitoring of bundle compliance with weekly feedback, communication, and education strategies, improvement of the documentation, and the use of antiseptic-impregnated discs for dressings. Despite the complexity of the patient population requiring long-term central lines, the CLABSI rate was greatly impacted by evidence-based interventions coupled with reinforcement of adherence to the bundle.Funding: NoneDisclosures: None

Association Between 2010 Medicare Reforms and Utilization of Postacute Inpatient Rehabilitation in Ischemic Stroke.

The aim of the study was to investigate whether the elimination of trial admissions and the initiation of documentation requirements, via the 2010 Centers for Medicare and Medicaid Services Inpatient Rehabilitation Facility Prospective Payment System Rule, limited inpatient rehabilitation facility access while increasing skilled nursing facility utilization compared with home discharge in ischemic stroke patients. This is a retrospective observational study using Get with the Guidelines - Stroke hospital data between January 1, 2008 and December 31, 2015 (N = 1,643,553). Between January 1, 2008 and December 31, 2009, 54.1% of patients went home, 25.4% to inpatient rehabilitation facility and 20.5% to skilled nursing facility. Between January 1, 2010 and December 31, 2015, there was a 1.4% absolute increase in home discharge, a 1.1% inpatient rehabilitation facility decline and a 0.3% skilled nursing facility decline.Within the 1.1% absolute decline in inpatient rehabilitation facility discharge, the adjusted odds of inpatient rehabilitation facility versus home discharge decreased 12% after 2010 Rule (adjusted odds ratio = 0.88, 95% confidence interval = 0.87-0.89, P < 0.0001). There was no statistically significant change in skilled nursing facility versus home discharge.Lower adjusted odds of inpatient rehabilitation facility discharge versus home discharge were identical across age groups and were present in all geographic regions. In populations with ischemic stroke, the Centers for Medicare and Medicaid Services 2010 Inpatient Rehabilitation Facility Prospective Payment System Rule was associated with a 1.1% absolute decrease in inpatient rehabilitation facility discharge, with a concomitant increase in home discharge rather than to skilled nursing facility.

Study of the Stability of Factor VIII Activity in Human Plasma for Fractionation When Modeling Deviations in the Storage and Transportation Temperature Conditions

The European Pharmacopoeia requires that the transportation and storage of human plasma for fractionation should be carried out at –20 °C or below, while allowing for some deviations in the temperature regime. The current Russian regulatory documentation requires the transportation and storage of plasma intended for the production of labile protein preparations (blood clotting factors) at –30 °C or lower. However, acceptable deviations from the temperature regime are not specified, which creates certain difficulties in their assessment by an authorised person during plasma batch release. The main tool in risk assessment is in-process control of factor VIII activity in plasma stored at inadequate temperature, which entails significant financial costs. The aim of the study was to assess stability of factor VIII activity in human plasma for fractionation when modeling deviations in the storage and transportation temperature regime and to assess the possibility of amending the regulatory documentation requirements. Materials and methods: only full individual doses of plasma obtained by apheresis were used in the experiments. The tests were performed under simulated high temperature conditions with accurate continuous recording of temperature by a measuring system. An automatic coagulation analyser was used to determine factor VIII activity. Quantitative evaluation of the results was carried out by comparing factor VIII activity in the plasma before freezing and in the tested plasma. Statistical processing of data was performed by descriptive statistics methods using Microsoft Excel 2007 applications. Results: no significant effect of short-term deviations in the storage temperature on the stability of factor VIII activity in human plasma for fractionation was observed. Conclusions: the obtained data can be used as a rationale for introducing changes in the official requirements for the storage and transportation temperature regime for human plasma for fractionation, as well as for including details of acceptable short-term deviations of the storage and transportation temperature regime in the regulatory documentation.

Assay for "fetal hemoglobin levels" in erythrocytes: Impact of new In Vitro Diagnostics regulation and expanded applications in sickle cell disease management.

Assay for "fetal hemoglobin levels" in erythrocytes: Impact of new In Vitro Diagnostics regulation and expanded applications in sickle cell disease management.

Requirements Engineering in Software Startups: A Systematic Mapping Study

Startups have high failure rates due to their inability to attain a sufficient product/market fit, i.e., delivering a solution that best matches the user needs in the market. Requirement engineering is the activity that could help startup teams identify the value proposition that provides high value to the users and continuously innovate it. The objective of the study is to analyse the state of art of the requirement engineering research in the context of startups, as available in the literature. The analysis of the research area highlights the research trends to achieve two things i.e., (a) predict how much support the startups can get from the literature for enhancing their success rates and (b) identify the research gaps to motivate researchers to conduct future research that could be adoptable in startup contexts. Systematic mapping is conducted on studies extracted from the four bibliographic databases (IEEExplore, ACM, Springerlink and ScienceDirect) and studies extracted by using a forward snowballing approach. Individual studies are coded to yield the classification scheme. Formulated schemes and those already available in literature, were populated with information extracted from the abstracts of the studies. The research is mostly focused on generic requirement engineering and product validation activities. The research is conducted mostly as evaluations (empirical studies) with the outcome of providing theory to the research community. Major underlying motivation of the research is to attain the product/market fit. However, research studies focusing on requirement documentation, prioritization and elicitation are losing focus from 2017, 2018 and 2019, respectively. The literature lacks the studies that reports research solutions which are validated in laboratory settings or in real contexts, experience reports, opinion papers and philosophical papers. The positive side of the finding is that the number of requirement engineering research studies in a startup context have increased in the past five years. At this instant, unfortunately the literature has limited ability to support startups by providing solutions (for instance, research solutions, evidence to support decision makings, best practices, experiences etc.) that are adoptable in their real context. Uniform focus of the researchers across all sub-activities of requirement engineering is required with effort distributed across different research types that supports startups, not only by providing validated solutions but experience reports, opinions, new conceptual frameworks and empirical evidence that can aid their decision making.

Juggling Between Paperwork and Patient Care: How Residents View Their Time Division in Clinical Training?

Objective: The objective of this study was to explore residents’ perception of time they spend on clinical data and patient care. Methods: A cross-sectional study, utilizing a validated questionnaire was conducted in July 2019 at the King Fahad Armed Forces Hospital, Jeddah after gaining ethical approval. Link to the online survey designed on Google forms was shared through Facebook, WhatsApp, and Email. The questionnaire consisted of 21 items to assess different variables like direct patient care, documentation requirements, and complete patient interaction. Results: Out of 150 participants, the response rate was 111 (74%). Of 111 participants, regarding clinical documentation, 105 (95%) felt that it has become excessive, and 93 (84%) agreed that it compromises patient time. In addition, 87 (78%) residents felt rushed all the time and 82 (74%) said that they are frustrated with data entry. On the educational value of clinical documentation, 90 (81%) of residents agreed that it has little or no influence. Furthermore, 92 (83%) agreed that it negatively impacts the time available for teaching other junior residents. Conclusion: We conclude that: although residents wish to provide quality care to their patients, many of them felt that data entry has become excessive and it is negatively affecting their clinical training.

Enabling trade across borders and food security in Africa

Widespread food insecurity remains a daunting challenge in Africa, despite significant gains in global efforts to eliminate hunger over the last three decades. This paper examines the effects of easing trade across borders – through reductions in documents, time, and costs to export and import – on food security outcomes in Africa. To control for endogeneity, this paper employs the first-difference instrumental variable estimator based on panel data covering 45 African countries over the period 2006–2015. The results reveal that poor trade facilitation constitutes a significant driver of food insecurity in Africa. In particular, ineffective trade facilitation is associated with significant increments in the prevalence of undernourishment and depth of food deficit, as well as reductions in dietary energy supply adequacy and access to sanitation facilities. The results show that food availability and food access are significantly hampered by higher documentation requirements and lengthier export and import times. The results suggest that reductions in delays from documentary and border compliance promise to be the most effective trade facilitation reforms to enhance food security in Africa.

How Health-Care Organizations Implement Shared Decision-making When It Is Required for Reimbursement: The Case of Lung Cancer Screening

The Centers for Medicare and Medicaid Services stipulate shared decision-making (SDM) counseling as a prerequisite to lung cancer screening (LCS) reimbursement, despite well-known challenges implementing SDM in practice. How have health-care organizations implemented SDM for LCS? For this qualitative study, we used data from in-depth, semistructured interviews with key informants directly involved in implementing SDM for LCS, managing SDM for LCS, or both. We identified respondents using a snowball sampling technique and used template analysis to identify and analyze responses thematically. We interviewed 30 informants representing 23 health-care organizations located in 12 states and 4 Census regions. Respondents described two types of SDM for LCS programs: centralized models (n= 7), in which front-end practitioners (eg, primary care providers) referred patients to an LCS clinic where trained staff (eg, advanced practice nurses) delivered SDM at the time of screening, or decentralized models (n= 10), in which front-end practitioners delivered SDM before referring patients for screening. Some organizations used both models simultaneously (n= 6). Respondents discussed tradeoffs between SDM quality and access. They perceived centralized models as enhancing SDM quality, but limiting patient access to care, and vice versa. Respondents reported ongoing challenges with limited resources and budgetary constraints, ambiguity regarding what constitutes SDM, and an absence of benchmarks for evaluating SDM for LCS quality. Those responsible for developing and managing SDM for LCS programs voiced concerns regarding both patient access and SDM quality, regardless of organizational context, or the SDM for LCS model implemented. The challenge facing these organizations, and those wanting to help patients and clinicians balance the tradeoffs inherent with LCS, is how to move beyond a check-box documentation requirement to a process that enables LCS to be offered to all high-risk patients, but used only by those who are informed and for whom screening represents a value-concordant service.

MULTINATIONAL TAX AVOIDANCE AND ANTI-AVOIDANCE ENFORCEMENT: FIRM-LEVEL EVIDENCE FROM DEVELOPING ASEAN COUNTRIES

We use firm-level data from ASEAN5 to examine the significance of tax-motivated profit shifting by multinational enterprises and to analyze how anti-avoidance measures mitigate the profit shifting. We show that (1) tax-motivated profit shifting is statistically and economically significant, especially for manufacturing firms, (2) auditing and transfer-pricing scrutiny is more effective in reducing profit shifting than documentation requirement alone and (3) tax-motivated profit shifting is prominent for large firms, while anti-tax avoidance measures result in the absence of profit shifting detected from small manufacturing firms. The findings have important implications for developing countries with weak governance but dependent on MNEs.

Standardization as an Instrument to Accelerate the Development of Stable Emerging Photovoltaic Technologies—The IEC TS 62876‐2‐1:2018—Technical Specification for the Stability Testing of Photovoltaic Devices Enabled by Nanomaterials

For new photovoltaic (PV) technologies the improvement and quantification of stability is a significant challenge. Accelerated aging tests are usually applied to shorten development times. While many of these tests exist, there is no standard that can serve as a guideline for choosing relevant tests and applying them correctly to achieve comparability between results. With the IEC TS 62876‐2‐1:2018 for the first time, a standard has been developed which defines the most significant testing protocols for stability. This standard is designed especially for third‐generation PV technologies that utilize nanomaterials but may be applied to any other new PV technologies as well. The standard defines the relevant stresses, recommends values for testing, defines seven standard tests, and provides reporting requirements for documentation. As a stability criterion the time t80, the time it takes for a measured efficiency of a device to reach 80% of the initial efficiency during the testing, is applied. A wide adoption of the tests outlined in the IEC TS 62876 significantly shortens development times and decreases the time to market for emerging PV technologies.

Requirements to Post Implementation Assessment in IT ERP projects

Requirement Analysis pertains to extracting the requirement out of the heaps of information that the Business analyst has acquired from various stakeholders and Requirement communication or documentation is putting it down in a form that is easily understood by the stakeholders, development and testing teams. Starting from Requirements gathering, Requirements management, Solution assessment, validation, testing to the final go live. Once the solution is implemented and user acceptance is completed. The solution is evaluated for how it is being used, what is the positive effect of solution implementation, what is the negative impact of solution implementation. Solutions may be adapted, changed or partially used by the users , manual processes might still be followed, redundant information may still be captured manually, these need to be studied and analyzed to understand why this is happening and can this be resolved, and can the adoption of new solution be increased. This paper focuses on what precedes the implementation and what follows the implementation in the post implementation evaluation phase.

The Use of Quality Metric To Control Quality Of Telecommunication Project (Case Study: Regional Metro Junction)

Regional Metro Junction is known as a telecommunication network project which connects one city to another city / village. This project has specific quality requirement to be achieved. However, the project executor didn’t meet the quality requirement from project owner because there’s no quality guideline in the planning process of the project, so it caused several quality problem in the execution process such as 2.700 meters twisted cable, 76 poles wrong location and 35 poles tilted. In addition to that, this paper aimed to design quality metric using internal control method as a guideline to control quality the project in order to minimize the potential of rework. The step of making this quality metric is identifying the possible issue of each activity, creating the critical success criteria of each activity based on requirement documentation then identifying the resources needed of each activity. The result shows that the number of defect is decreasing as much 750 meters for the twisted cable, 44 wrong pole location and 27 tilted pole. At the end, this quality metric guideline is useful to minimize the defect of the project and can be lesson learned for another project.

Development and Implementation of Clinical Outcome Measures for Automated Collection Within Specialty Pharmacy Practice.

Johns Hopkins Specialty Pharmacy Services recognized the need to identify and develop standardized collection methods for clinical outcome measures (COMs) to demonstrate program quality and value to third-party payers, manufacturers, and internal stakeholders. To define specialty COMs and develop a framework for standardized data collection and reporting. COMs for specialty pharmacy disease states (cystic fibrosis; hepatitis C; inflammatory conditions in dermatology, gastroenterology and rheumatology; and multiple sclerosis) were identified through a literature search, collaboration with specialty pharmacists, and committee review. Once identified, these measures were distributed to internal and external stakeholders that included specialty clinic team members, drug manufacturers, and third-party payers for input and validation. A standardized process for discrete documentation and data collection of these measures was implemented using case management software, electronic medical record integration, and informatics support. 28 COMs were identified. The various data sources used to collect the COMs were incorporated into an automated virtual dashboard to allow for regular review and sharing with clinicians, leadership, and other key stakeholders. The virtual dashboard included COMs with data derived from electronic medical records (n = 9), patient-reported outcomes based on responses to pharmacist-delivered questions (n = 11), and pharmacist assessment of outcomes (n = 8). The completed virtual dashboard was further refined to allow for reporting of both population and patient-level outcome results on a quarterly basis. This project describes methods to standardize documentation, data collection, and reporting of clinical outcomes data for multiple specialty conditions in a health system-integrated specialty pharmacy program. Through literature review and stakeholder consultation, a variety of potential COMs were identified for further evaluation of feasibility and value considering documentation and data collection requirements. Incorporation of COMs into a virtual dashboard will help facilitate the evaluation of program effectiveness, quality improvement planning, and sharing with stakeholders. Additional opportunities exist to further standardize COMs across the pharmacy industry to allow for future benchmarking and standardized evaluation of patient care programs. No funding supported the writing of this article. The authors have no relevant conflicts of interest to disclose. This study was presented as a poster presentation at the APhA Annual Meeting, March 2018, Nashville, TN, and as a platform presentation at the Eastern States Conference, May 2018, Hershey, PA.

Evaluation of Burnout and Work-Life in Surgical Trauma Acute Care Units.

Stressors unique to trauma patients may potentiate burnout in the trauma care team. Among health care workers, nurses historically demonstrate high rates of burnout and are often the first caregivers in which patients interact. There is limited research, however, investigating burnout in trauma nurses. This study aims to evaluate levels of burnout and perceptions of work-life in nurses and ancillary staff at a Level 1 trauma center. An anonymous, cross-sectional, online survey was administered utilizing the Maslach Burnout Toolkit to investigate levels of burnout and work-life. Supplemental questions developed by investigators were included to gather additional details about the work environment. A total of 126 trauma staff completed the survey yielding a response rate of 73%. Trauma staff exhibited low degrees of emotional exhaustion (M = 2.53, SD = 1.29) and depersonalization (M = 1.83, SD = 1.33). Staff with 4 to less than 9 years of tenure at the study institution experienced these emotions at the highest level. Overall, staff cited documentation requirements and patient-to-staff ratios as prominent concerns with their work-life. There were significant negative associations between manageable workload with emotional exhaustion (r = -0.68) and depersonalization (r = -0.56). Overall, low degrees of emotional exhaustion and depersonalization were exhibited, but significant increases were noted in staff with increasing tenure. These findings suggest that cited aspects of work-life may impact the development of emotional exhaustion and depersonalization over time. Pilot interventions are underway to identify an acuity-adjusted staffing process and a user-friendly electronic documentation platform to improve the institution's work environment.