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Background: Our organization is a NGO that provides palliative and supportive care at outpatient (OP), home visits and inpatient (IP), and Hospice settings. During patient encounter at different settings, documentation of discussion on prognostication was not done on the patients’ case sheets. This had created communication gap between the professionals, the patients and their family members. Due to this, there was a mismatch between the patients’ expectations and the services provided. Aims: The aim of the study was to implement A3 protocol and to increase the documentation status from zero to 75% by the end of five months after the commencement of the project. Settings and Design: OP - Department of Palliative Care Clinic A3 method. Material and Methods: The process map of the newly registered patients was followed. Root cause analysis was done using the Ishikawa Diagram. The main cause was that there was no specific format for documentation of prognostication. The professionals also felt some difficulty in disclosing the information as they were not following any prognostication tools upon which such discussions can be made. The key drivers were identified. Interventions were focused with specific contributors. A run chart was maintained to assess the progress of the interventions Statistical Analysis Used: Percentage calculation. Results: This endeavor has resulted in raising the documentation status from 0 to 80%. Conclusion: A3 protocol has been successful in developing the format for documentation of prognostication. Our team has gained confidence in implementing the A3 in other domains too.

OBJECTIVES For hospitalized children and their families, laboratory study collection at night and in the early morning interrupts sleep and increases the stress of a hospitalization. To change this practice, our quality improvement (QI) study developed a rounding checklist aimed at increasing the percentage of routine laboratory studies ordered for and collected after 7 am. METHODS Our QI study was conducted on the pediatric hospital medicine service at a single-site urban children’s hospital over 28 months. Medical records from 420 randomly selected pediatric inpatients were abstracted, and 5 plan-do-study-act cycles were implemented during the intervention. Outcome measures included the percentage of routine laboratory studies ordered for and collected after 7 am. The process measure was use of the rounding checklist. Run charts were used for analysis. RESULTS The percentage of laboratory studies ordered for after 7 am increased from a baseline median of 25.8% to a postintervention median of 75.0%, exceeding our goal of 50% and revealing special cause variation. In addition, the percentage of laboratory studies collected after 7 am increased from a baseline median of 37.1% to 76.4% post intervention, with special cause variation observed. CONCLUSIONS By implementing a rounding checklist, our QI study successfully increased the percentage of laboratory studies ordered for and collected after 7 am and could serve as a model for other health care systems to impact provider ordering practices and behavior. In future initiatives, investigators should evaluate the effects of similar interventions on caregiver and provider perceptions of patient- and family-centeredness, satisfaction, and the quality of patient care.

Objective Fewer than 50% of children with developmental delay are identified before they start school, and only 10% of those identified receive services. Between May 2014 and August 2016, the Home Visiting Collaborative Improvement and Innovation Network (HV-CoIIN) aimed to improve early detection and linkage to services so that 80% of children with an identified developmental concern would receive timely, targeted developmental support. Methods HV-CoIIN enrolled 13 home visiting programs in eight states and one tribe in a Breakthrough Series Collaborative (BTS). These programs tested interventions aligned with five key drivers: early detection, referral and follow-up, home visitor capacity, families engaged in developmental promotion, and data systems. Run charts were used to study measures. The main outcome was the percent of children with an identified concern that were linked to developmental support. Process measures included the percent of visits where parents were asked if they had any concerns about their child's development and the percent of children screened every six months. Results The percent of children with an identified developmental concern that received support increased from 70% to 82%. Parents were asked about developmental concerns at 95% of visits (baseline = 75%), and 90% of children were screened every six months (baseline = 51%). Conclusion Home visiting programs can reliably execute early detection and linkage to services for at-risk populations they serve. BTS holds promise for improving implementation of federal public health programs to improve population health outcomes.

BackgroundPerceived health-related quality of life (HRQOL) is fundamental to well-being and is a meaningful way to measure physical and mental health.Local ProblemNo standard method exists for measuring perceived HRQOL during the COVID-19 pandemic in participants as they attempt to improve their self-determined wellness goals. An implementation plan that considers the social distancing limitations imposed can be used to predict an individual's likelihood of long-term success.MethodsDuring the four, 2-week plan-do-study-act (PDSA) cycles, the Social Cognitive Theory model informed the implementation of the four core interventions. To guide iterative changes, the data was analyzed through Excel and run charts.InterventionsThe four core interventions were the shared decision-making tool (SDMT), health mobile app tool (HMAT), wellness tracker tool (WTT), and the team engagement plan.ResultsAmong 28 participants, perceived quality of life increased by 70%, engagement in shared decision-making increased to 82%, app use and confidence increased to 85%, and goal attainment reached 81%.ConclusionsThe SDMT, health app, and wellness tracker created a methodical plan of accountability for increasing participant wellness. The contextual barrier of the COVID-19 pandemic added a negative wellness burden which was mitigated by creating a patient-centered culture of wellness.

Purpose/aims This study illuminates the workforce of the clinical nurse specialist (CNS), using data from the National Provider Identifier (NPI) registry. Design This is a descriptive exploratory study using CNSs' self-reported data within the NPI registry through December 2019. Methods Tabulations for frequencies of available demographics, population foci/specialty, and tests for differences in urban/rural locations were conducted. Clinical nurse specialists practicing as nurse practitioners were also counted and identified. Run charts were used to assess quarterly trends for CNSs obtaining new NPIs. Results Ten thousand CNSs were registered with an NPI, and 9470 reported 1 population foci/specialty. Furthermore, 1932 CNSs (19.3%) also report working as a nurse practitioner. Only 2 CNS specialties differed by more than 4% between urban and rural areas (respectively): family health (7.7% and 15.5%) and CNSs without a specialty (17.1% and 12.6%). Run charts identified 5 specialties with changing trends in new NPI enumerations (family health, adult-gero, postacute care, pediatrics, and women's health). Conclusions Of the estimated 89 122 CNSs in the United States, only 11.2% of the CNS workforce was described and accounted for within the NPI registry. Clinical nurse specialists are encouraged to register for an NPI. Further research is necessary to describe the location and type of work CNSs are performing within the US healthcare system.

Hospitals are increasingly motivated to improve the patient and family experience and increase patient satisfaction scores. The manner by which a provider greets patients and their families sets the tone for the hospital stay. This study aimed to improve residents' greetings of caregivers in the inpatient pediatric setting to improve family-centered communication. The study was conducted from October 2017 to April 2018 at a single, urban children's hospital on a unit with patients primarily

Background and Objectives: The patient panels of graduating residents must be reassigned by the end of residency. This process affects over 1 million patients annually within the specialty of family medicine. The purpose of this project was to implement a structured, year-end reassignment system in a family medicine residency program. Methods: Our structured reassignment process took place from December 2017 through June 2020. Panel lists of current, active patients were generated and residents were responsible for reassigning their own panels during a panel reassignment night. We created a tip sheet that addressed patient complexity and continuity, a risk stratification algorithm based on patients’ medical and social complexity, and a tool that tracked the number of patients assigned to each future provider. Outcome measures included a resident satisfaction survey administered in 2018-2020 and patient-provider continuity measured with a run chart from December 2016 through August 2020. Results: The resident survey response rate was 75%. Seventy-three percent felt the panel reassignment night was very helpful; 87% thought the reassignment timeline was extremely reasonable, and 87% indicated that they had the necessary information to reassign their patients. Residents also felt confident that their patients were reassigned appropriately (33% extremely confident, 67% somewhat confident). Patient continuity improved with a 13-point run above the median, indicating nonrandom variation. Patient continuity remained above the median until the impact of COVID-19 in April 2020. Conclusion: Our structured reassignment process was received positively by residents and resulted in improved patient continuity.

BACKGROUND: Studies of seizure management in the pediatric inpatient setting are needed. Seizures recorded by video EEG provide an opportunity to quantitatively evaluate acute management. We observed variation in delivery of standardized seizure safety measures (seizure first aid) during epilepsy monitoring unit admissions at our hospital. Our goals were to increase consistency and speed of seizure first aid and neurologic assessment in acutely seizing patients. METHODS: Using a root cause analysis, we identified major factors contributing to variation in seizure management and key drivers for improvement. Targeted interventions, centered around a protocol for acute seizure management, were implemented through quality improvement methodology. The primary outcome was correct performance of standardized seizure first aid and neurologic assessment. Secondary outcomes were time intervals to each assessment. Run charts were used to analyze primary outcomes, and statistical control charts were used for secondary outcomes. Nursing confidence in seizure management was determined through pre- and postsurveys and analyzed with the χ2 test. RESULTS: Thirteen seizures were evaluated in the preintervention phase and 10 in the postintervention phase. Completed components of seizure first aid increased from a median of 3 of 4 to 4 of 4; completed components of neurologic assessment increased from a median of 2 of 4 to 4 of 4. Responses to acute seizures were faster, and nursing confidence increased. CONCLUSIONS: A collaborative quality improvement effort between physicians and nurses led to prompt and correct delivery of seizure first aid by first responders. These relatively simple interventions could be adapted broadly to improve acute seizure management in the pediatric inpatient setting.

BACKGROUND:Diagnostic uncertainty may be a sign that a patient’s working diagnosis is incorrect, but literature on proactively identifying diagnostic uncertainty is lacking. Using quality improvement methodologies, we aimed to create a process for identifying patients with uncertain diagnoses (UDs) on a pediatric inpatient unit and communicating about them with the interdisciplinary health care team.METHODS:Plan-do-study-act cycles were focused on interdisciplinary communication, structured handoffs, and integration of diagnostic uncertainty into the electronic medical record. Our definition of UD was as follows: “you wouldn’t be surprised if the patient had a different diagnosis that required a change in management.” The primary measure, which was tracked on an annotated run chart, was percentage agreement between the charge nurse and primary clinician regarding which patients had a UD. Secondary measures included the percentage of patient days during which patients had UDs. Data were collected 3 times daily by text message polls.RESULTS:Over 13 months, the percentage agreement between the charge nurse and primary clinician about which patients had UDs increased from a baseline of 19% to a median of 84%. On average, patients had UDs during 11% of patient days.CONCLUSIONS:We created a novel and effective process to improve shared recognition of patients with diagnostic uncertainty among the interdisciplinary health care team, which is an important first step in improving care for these patients.

IntroductionAt the early epicentre of the COVID-19 crisis in the USA, our institution saw a surge in the demand for inpatient consultations for areas impacted by COVID-19 (eg, infectious diseases, nephrology, palliative care) and shortages in personal protective equipment (PPE). We aimed to provide timely specialist input for consult requests during the COVID-19 pandemic by implementing an Inpatient eConsult Programme.MethodsWe used the reach, effectiveness, adoption, implementation and maintenance implementation science framework and run chart analysis to evaluate the reach, adoption and maintenance of the Inpatient eConsult Programme compared with traditional in-person consults. We solicited qualitative feedback from frontline physicians and specialists for programme improvements.ResultsDuring the study period, there were 46 available in-person consult orders and 21 new eConsult orders. At the peak of utilisation, 42% of all consult requests were eConsults, and by the end of the study period, utilisation fell to 20%. Qualitative feedback revealed subspecialties best suited for eConsults (infectious diseases, nephrology, haematology, endocrinology) and influenced improvements to the ordering workflow, documentation, billing and education regarding use.DiscussionWhen offered inpatient eConsult requests as an alternative to in-person consults in the context of a surge in patients with COVID-19, frontline physicians used eConsult requests and decreased use of in-person consults. As the demand for consults decreased and PPE shortages were no longer a major concern, eConsult utilisation decreased, revealing a preference for in-person consultations when possible.ConclusionsLessons learnt can be used to develop and implement inpatient eConsults to meet context-specific challenges at other institutions.

Objective Rheumatoid arthritis (RA) disease activity assessment is critical for treatment decisions and treat to target (T2T) outcomes. Utilization of the electronic medical record (EMR) and techniques to improve the routine capture of disease activity measures in clinical practice are not well described. We leveraged a Lean Six Sigma (LSS) approach, a data‐driven five‐step process improvement and problem‐solving methodology, coupled with EMR modifications to evaluate improvement in disease activity documentation and patient outcomes. Methods A RA registry was established, and structured fields for Routine Assessment of Patient Index Data (RAPID3) and Clinical Disease Activity Index (CDAI) were built in the EMR, along with a dashboard to display provider performance rates. An initial rapid‐cycle improvement intervention was launched, and subsequent LSS improvement cycles helped in standardization of clinic workflow, modifying provider behaviors, and motivating better documentation practices. Trends related to CDAI score categories were compared over time using run charts. Results Our project included 1322 patients with RA and 10 241 encounters between April 2016 and December 2019. Initially, RAPID3 completion rates increased from 16% to 50%, and CDAI from 15% to 44% from the RCI intervention. Post LSS intervention, the RAPID3 rate increased to more than 90% (sustained at 85%), and CDAI rate increased to more than 80% (sustained at 72%). The patients in the low disease/remission category increased from 54% to 66% (p < 0.001), and those in the high disease category decreased from 15% to 7% (p < 0.001), demonstrating improved T2T outcomes. Conclusion Combining EMR modifications with systems redesign utilizing LSS approach led to impressive and sustained improvement in disease activity documentation and T2T outcomes.

Background: Countries launch vaccination programs to ensure vaccination coverage as part of the global health security. Special populations including patients with severe mental illness are under average vaccination rate. We aimed to improve the percentage of long-term patients in Qatar's mental health services who received their routine vaccination by the end of 2020 from a baseline rate of 10% to 90% from all vaccination types needed. Methods: This was an interrupted time series quality improvement project using two structured Plan-Do-Study-Act cycles to test the success of the outcome and process measures to reach the desired aim. Run charts were utilized to display the monthly vaccination rates as an outcome measure and the rate of vaccination refusals by the patients as a process measure. A multidisciplinary team was assembled. Root cause analysis was performed. Prioritizations for certain types of vaccines to be given were done. Results: We identified 50 eligible patients. Throughout 12 months, we reached a final vaccination rate of 92%. Number need to treat was used to express the effect size and was calculated as 1.2. Refusals to vaccinations by patients dropped from 41% at the start of the project to only 4% by the end. Conclusion: High vaccination rates over a 12-month period can serve as an indication for the success of the intervention. Sustainability of the results can be achieved by multiple strategies. These results may be useful to hospitals considering vaccine implementation or those currently struggling with implementation barriers.

Objective To assess whether standardized screening and service navigation improve access to primary care in low wage workers. Methods Four rapid plan-do-study-act cycles were conducted over an 8-week period. Each cycle consisted of four core interventions. Data were collected every 2 to 3 days, then analyzed on run charts and aggregate data tables. Results Effective care was achieved by increasing the percentage of patients with a primary care provider from 52% to 79%. Patients' perception of health increased from 3.6 to 4.4 and team communication and support score increased from 3.9 to 4.2 on a 5-point Likert scale. Conclusions Patient engagement and a standardized referral process aids in the establishment of routine, effective care. Application of "smart phrases" in electronic health records provides sustainability for use in other occupational medicine practices.

Objectives Direct admission refers to admitting a patient to a unit avoiding usual entry points such as the emergency department. Inappropriate placement of direct admissions can result in rapid response activations, codes and unanticipated pediatric intensive care unit (PICU) transfers, which correlate with higher mortality and longer lengths of stay. The objective of the project was to improve the safety of the direct admission process as evidenced by decreasing the transfer of direct admission patients to the PICU within 6 hours. Methods Utilizing the model for improvement, a multidisciplinary team was assembled to improve our screening process and reduce unanticipated direct admission-to-PICU transfers within 6 hours of arrival. Our emergency department-based direct admission process includes screening vital signs (temperature, heart rate, respiratory rate, blood pressure, and pulse oximetry) and a Pediatric Early Warning Score. Five Plan-Do-Study-Act cycles focused on role definition, improved documentation, referring facility and family awareness, improved visual management within the ED, and education of partner EMS and transport providers. The primary outcome was PICU transfer within 6 hours of direct admission arrival. Compliance with full screening was a process measure and number of direct admissions a balancing measure. Statistical process control charts and run charts were used to follow the measures. Results The total number of direct admissions from January 2014 to the end of data collection, June 2018, was 3070 patients. Screening protocol compliance improved from 56% to over 80% for the entire hospital. Unanticipated direct admission-to-PICU transfers decreased from a baseline of 1 every 98 patients to a special cause of 1 in 1126 patients. Conclusions By utilizing QI methodology our team was able to implement and sustain a direct admission process that was more consistent, easier to document and improved the safety of our patients. Our study demonstrates that screening direct admissions reliably and consistently can decrease the rate of unanticipated transfer to a higher level of care.

Clear communication of statistical approaches can ensure healthcare research is well understood, reduce major errors and promote the advancement of science. Yet in contrast to the increasing complexity of data and analyses, published methods sections are at times insufficient for describing necessary details. Therefore, ensuring the quality, transparency and reproducibility of statistical approaches in healthcare research is essential.1 2 Such concerns are not just theoretical and have direct implications for research in the quality and safety field. For example, the Hospital Readmissions Reduction Program was instituted in 2012 by the US Centers for Medicare & Medicaid Services (CMS) and imposed financial penalties on hospitals with high readmission rates. Subsequent studies sought to determine the extent to which this programme was successful in reducing readmissions without promoting unintended consequences, such as increased mortality. Clearly defining the success or failure of this programme is essential, but in 2018 two prominent articles using the same CMS data set presented opposing results.3 4 These conflicts are undoubtedly due to differences in analytical choices, but specific differences are challenging to reconcile given statistical code was unavailable to readers. In another recent example, a major article was retracted due to the discovery of a statistical coding error that reversed the categorisation of treatment and control groups.5 This clinical trial examined a support programme for hospitalised patients with chronic obstructive pulmonary disease, originally reporting a lower risk of hospitalisation and emergency department visits, but in actuality demonstrating the support programme was associated with harm. Both cases demonstrate how better practices with statistical coding sharing at the time of publication may improve the quality of research. While the utility of statistical code sharing may seem self-evident, it occurs more infrequently than one would expect.2 We believe a principal barrier to statistical code sharing is …

Introduction: The COVID-19 pandemic has resulted in unprecedented changes to the delivery of maternity care across Australia, including RANZCOG-endorsed measures to reduce antenatal visits, and implement telehealth. We analysed trends in maternity consultations and the uptake of telehealth in VIC and NSW since the first COVID-19 pandemic restrictions were introduced in late March 2020. Methods: Episodes of outpatient antenatal and post-natal consultations and obstetric ultrasounds from January 2018 to September 2020 were obtained using Australian Government Medicare Statistics data from NSW and VIC. Run charts using pre-pandemic median from January 2018 were generated. A significant trend was defined as five consecutive months of numbers all going up or down.1 Utilisation of telehealth consultations was compared between VIC and NSW using the z-test for difference in proportions. Results: Despite a decline in monthly face-to-face consultations in Victoria and NSW (16% and 12% decline from pre-COVID medians of 32,413 and 41,848, respectively), there was no significant downward trend in total attendances during the first lockdown. A higher proportion of antenatal and post-natal care was delivered via telehealth/telephone in Victoria compared to NSW (19.4% vs 9.4%, respectively, p < 0.0001). From March 2020 in Victoria, the run chart showed a trend towards increased ultrasound examinations for women with a singleton pregnancy after 22 weeks. Discussion: Widespread uptake of telehealth has been a major contributor to maintaining maternity consultations during Victorian pandemic restrictions. Further research is required to understand the increase in ultrasound billings during lockdown in Victoria.

Objective Project ECHO (Extension for Community Healthcare Outcomes), a telementoring program, utilizes lectures, case‐based learning, and an “all teach–all learn” approach to increase primary care provider (PCP) knowledge/confidence in managing chronic health conditions. The American Academy of Pediatrics (AAP) Epilepsy and Comorbidities ECHO incorporated quality improvement (QI) methodology to create meaningful practice change, while increasing PCP knowledge/self‐efficacy in epilepsy management using the ECHO model. Methods Monthly ECHO sessions (May 2018 to December 2018) included lectures, case presentations/discussion, and QI review. Pediatric practices were recruited through the AAP. Practices engaged in ECHO sessions and improvement activities including monthly Plan‐Do‐Study‐Act cycles, team huddles, chart reviews, and QI coaching calls to facilitate practice change. They were provided resource toolkits with documentation templates, safety handouts, and medication side effects sheets. QI measures were selected from the American Academy of Neurology Measurement Set for Epilepsy. The AAP Quality Improvement Data Aggregator was used for data entry, run chart development, and tracking outcomes. Participants completed retrospective surveys to assess changes in knowledge and self‐efficacy. Results Seven practices participated across five states. Average session attendance was 14 health professionals (range = 13‐17). A total of 479 chart reviews demonstrated improvement in six of seven measures: health care transition (45.3%, P = .005), safety education (41.6%, P = .036), mental/behavioral health screening (32.2% P = .027), tertiary center referral (26.7%, not significant [n.s.]), antiseizure therapy side effects (23%, n.s.), and documenting seizure frequency (7.1%, n.s.); counseling for women of childbearing age decreased by 7.8%. Significance This project demonstrated that integrating QI into an ECHO model results in practice change and increases PCP knowledge/confidence/self‐efficacy in managing epilepsy.

Background Every year, about 50 babies in New York City die from a sleep-related injury. The Bronx County ranked second highest rate of sleep-related infant deaths (SRID) at 0.5 per 1000 among the other boroughs. The highest rate was among blacks and the rate of SRID cases were highest in our population at 0.97 (zip code 10466) among all other Bronx neighborhoods which comprises 77% of non-Hispanic black population. Further, Bronx has the highest preterm birth rate at 9.5%. This quality improvement (QI) project aimed to develop and implement an educational initiative on infant safe sleep (SS) to improve "Safe Sleep Practices (SSP) in a level III neonatal intensive care unit (NICU) for one of the highest risk populations in the country. Methods Baseline data was collected prior to initiating the QI project. Multiple plan-do-study-act (PDSA) cycles were completed over a 12 month period. Run charts were utilized to identify improvement and guide interventions. These interventions included education for nurses, crib cards, posters, feedback forms, grand rounds and small group discussions. Results Approximately 600 crib checks (CC) were performed over the duration of this project. At baseline, 7% of infants were placed in a SS position in the NICU. Following the QI project, SS position increased to 96% of infants. Conclusion Multifactorial interventions significantly improved SS compliance among NICU nurses. Cultivating personal motivation among nurses, consistent empowerment and dedication to culture change by the entire team was crucial for the sustainability of the project.

Hospital closures promote latent factors putting patients at risk for medical errors. Our goal was to maintain safe patient care in our Neonatal Intensive Care Unit (NICU) by preventing any increase in neonatal mortality or hospital-based complications prior to hospital closure. Interventions included expanding TeamSTEPPS huddles and Leadership WalkRoundsTM. Measurements of safety domains were conducted using the Safety Attitudes Questionnaire. A run chart tracked neonatal mortality. We compared hospital-based complications for all neonatal admissions in 2019 with our own past outcomes and Vermont Oxford Network (VON) benchmarks. Teamwork climate scores increased from an average score of 24.6–28.3 (maximum score 30, P

Measurement is a core foundation of quality improvement (QI), and analysis of data for QI requires distinct approaches and tools as compared with other areas of healthcare. QI efforts can use structural, process, outcome, and balancing measures, and each measure should have a clear operational definition. Data for improvement should be analyzed dynamically over time, with a focus on understanding the variation present in the data. Distinguishing between common cause and special cause variation is necessary to evaluate and guide improvement efforts. Statistical process control tools such as run charts and control charts can be powerful tools to analyze data over time and help understand variation. This article continues a series of QI educational papers in the Journal of Perinatology, and offers a review of the use of data and measures to drive improvement.

Background Barcode-assisted medication administration (BCMA) is an evidence based practice to reduce medication administration errors; however, compliance rates with the use of this technology sometimes vary between different healthcare workers. Improving BCMA compliance benefits healthcare organizations in their efforts towards Zero Harm. Objectives Achieve less than 2% BCMA overrides at a pediatric hospital, within a 12 months’ timeframe. Methods To improve BCMA adherence across all disciplines, the IHI’s QI Essentials Toolkit was used to guide an interprofessional team of nurses, physicians, pharmacists, respiratory therapists, imaging techs and quality professionals. The team came together to conduct a Failure Mode and Effects Analysis (FMEA) and identify units with overrides rates above 2% to build a task force (figure 3). A nurse manager was identified as the task force leader and every unit was represented by a leader and a worker at the point of care. The task force prioritized addressing knowledge, attitudes and behaviors towards BCMA and applied change concepts to engage the workforce in using the technology. This priority was backed up by availability of weekly data that allowed drilling down to individual measurement of medications administered and BCMA use. Continuous improvement was tracked through run charts that displayed organizational and unit-level results starting with pre-interventions baseline data. Results A sustained BCMA overrides rate below 2% was achieved, with a mean of 1.26 (figures 1 and 2). Conclusions When introducing an interprofessional team to proactive risk assessment and continuous improvement, the IHI’s QI Essentials Toolkit proved effective in providing the team with tools to prioritize efforts, test change, achieve results and sustain improvement over time, all while supporting organizational learning.

This work describes the lyophilization process validation and consists of two parts. Part one (Part I: Process Design and Modeling) focuses on the process design and is described in the previous paper, while the current paper is devoted to process qualification and continued process verification. The goal of the study is to show the cutting edge of lyophilization validation based on the integrated community-based opinion and the industrial perspective. This study presents best practices for batch size determination and includes the effect of batch size on drying time, process parameters selection strategies, and batch size overage to compensate for losses during production. It also includes sampling strategies to demonstrate batch uniformity as well as the use of statistical models to ensure adequate sampling. Based on the LyoHUB member organizations survey, the best practices in determining the number of PPQ runs are developed including the bracketing approach with minimum and maximum loads. Standard practice around CQA and CPP selection is outlined and shows the advantages of using control charts and run charts for process trending and quality control. The case studies demonstrating the validation strategy for monoclonal antibody and the impact of the loading process on the lyophilization cycle and product quality as well as the special case of lyophilization for dual-chamber cartridge system are chosen to illustrate the process validation. The standard practices in the validation of the lyophilization process, special lyophilization processes, and their impact on the validation strategy are discussed. Graphical Abstract

BackgroundThe COVID-19 pandemic has resulted in a range of unprecedented disruptions to maternity care with documented impacts on perinatal outcomes such as stillbirth and preterm birth. Metropolitan Melbourne has endured one of the longest and most stringent lockdowns in globally. This paper presents the protocol for a multicentre study to monitor perinatal outcomes in Melbourne, Australia, during the COVID-19 pandemic.MethodsMulticentre observational study analysing monthly deidentified maternal and newborn outcomes from births >20 weeks at all 12 public maternity services in Melbourne. Data will be merged centrally to analyse outcomes and create run charts according to established methods for detecting non-random ‘signals’ in healthcare. Perinatal outcomes will include weekly rates of total births, stillbirths, preterm births, neonatal intensive care admissions, low Apgar scores and fetal growth restriction. Maternal outcomes will include weekly rates of: induced labour, caesarean section, births before arrival to hospital, postpartum haemorrhage, length of stay, general anaesthesia for caesarean birth, influenza and COVID-19 vaccination status, and gestation at first antenatal visit. A prepandemic median for all outcomes will be calculated for the period of January 2018 to March 2020. A significant shift is defined as ≥6 consecutive weeks, all above or below the prepandemic median. Additional statistical analyses such as regression, time series and survival analyses will be performed for an in-depth examination of maternal and perinatal outcomes of interests.Ethics and disseminationEthics approval for the collaborative maternity and newborn dashboard project has been obtained from the Austin Health (HREC/64722/Austin-2020) and Mercy Health (ref. 2020-031).Trial registration numberACTRN12620000878976; Pre-results.

BACKGROUND AND OBJECTIVES Graduated autonomy is fundamental as trainees transition to independent practice. Family-centered rounds (FCR), the leading model of inpatient rounding in pediatrics, is an opportunity for trainees to demonstrate their competence in leading a health care team, which is an entrustable professional activity for all pediatric residents. At our institution, senior residents (SRs) at baseline performed at a novice level on the basis of the Senior Resident Empowerment Actions 21 (SREA-21), a validated tool that is used to assess SR autonomy during FCR. Our objective for this study was to increase the median percentage of SREA-21 domains in which SRs perform at a competent level from 38% to 75% within 6 months. METHODS Researchers observed 4 FCR encounters weekly and calculated SREA-21 scores after 2 weeks on the basis of actions promoting SR autonomy performed by the SR-hospitalist dyad. The primary outcome measure was the percentage of SREA-21 domains in which the SR achieved a competent score on the SREA-21. We used the model for improvement to identify key drivers and test proposed interventions using serial plan-do-study-act cycles. Interventions included creation of unified inpatient SR expectations, introduction of a SR-hospitalist pre-FCR huddle, auditing of FCR interruptions, and direct feedback to the SR-hospitalist dyad after FCR. Run charts were used to track SR and hospitalist scores on the SREA-21. RESULTS After multiple plan-do-study-act cycles, there was special cause improvement with a desirable shift upward in the centerline to 100%, which correlated with the project’s interventions and surpassed our goal. CONCLUSIONS Using quality improvement methodology, we improved SR autonomy during FCR, as measured by the SREA-21.

BackgroundPediatric appendicitis accounts for an estimated 7% to 10% of abdominal pain cases in the emergency department (ED). The diagnosis is time-consuming, and the investigative process depends on physician assessment, resulting in delays in diagnosis and therapeutic management. The utility of an advanced nursing directive (AND) to expedite this process is unclear and needs further exploration.ObjectiveThis study aims to describe key components of ED flow in patients with suspected appendicitis seen at a pediatric ED and pilot a directive that allows ED nurses to perform an order set that includes blood work, urine tests, analgesics, fluids, and an abdominal-pelvis ultrasound prior to physician assessment.MethodsThis study involves conducting a retrospective chart review alongside a quality improvement initiative to compare key ED flow metrics before and after AND implementation. Primary outcome measures include median time from ED triage assessment to ultrasound completion, analgesia administration, blood work results, and time to disposition (consult or discharge), alongside other key ED flow metrics for suspected appendicitis. Secondary outcomes will involve patient and caretaker satisfaction surveys. Descriptive statistics will be used to summarize the data. For differences in proportions, a chi-square test will be used. The Student t test will be used for continuous variables. A variable-controlled run chart will be performed to assess impact on ED flow metrics. Patient and family satisfaction surveys are administered immediately after the directive encounter and 7 days afterward.ResultsThere are currently 3900 patients who have been screened, 344 patients who have been enrolled, and 90 patients who have received the medical directive since implementation in June 2020. Interim results on reduction of time to diagnostic and therapeutic ED flow parameters and satisfaction surveys are expected to be published in February 2022. The final study endpoint will be in June 2022.ConclusionsThis study proposes a novel protocol for improving the diagnosis and treatment of suspected pediatric appendicitis through implementation of an evidence-based AND. This model may provide a standardized, international pathway for management of common pediatric and adult emergencies.International Registered Report Identifier (IRRID)RR1-10.2196/33158

AIM: Increase the # of San Francisco Medi-Cal Dental insurance member patients 0-5 years old seen in participating dental homes by 10% above baseline between 1/2019-12/2020 Methodology: The Model for Improvement strategy using Aim statements, Measurements, and Ideas for testing with serial Plan-Do-Study- Act cycles refined our evolving driver diagram and change package;all lovingly called Virtuous Learning Cycles by our improvement specialist Measurements: Run Charts showing baseline # of patients with weekly access data over a series of sprints measured access to care Ideas: Medi-Cal Dental providers strive to provide care to children, but need help learning how to do so Collaboration with faculty team members allow crafting of continuous learning cycles in overlapping spheres such as QI method utilization, experiences of past participants of QI collaboratives, evidence-based preventive dental care and noninvasive caries management, cavity risk assessments, infant oral examination workflows, and motivational interviewing Stakeholders at the table: -Medi-Cal Dental network Dental Providers -Faculty team members-Irene Hilton, AFL Enterprises, Brandon Bennett, Ray Stewart, Peter Milgrom, Ramona English, An Nguyen, and Lyra Ng are the QI-minded Dentists, QI educators, collaborative facilitators, and content leaders on motivational interviewing in dentistry, evidence-based pediatric dentistry and a pediatrician for insight into child-centered primary care What transpired? Parallel PDSA cycles-Participants and Collaborative: Access to care measurements: A total of 568 patients 0-5 years old were seen whom would not have otherwise been seen without SF DTI -Learning cycles enhanced participant level change ideas leading to increased access to care in both pilot and cohort 1 sessions -Aggregate data from Cohort 1 showed an increase in children seen by all teams until COVID-19 Shelter in Place (SIP) was implemented in the San Francisco Bay Area on 3/17/2020 Note the breadth of interventions studied (1) Exciting real-time PDSAs at the Collaborative level: Organizational PDSAs on highlevel programming allowed rapid pivoting on the process and delivery of Collaborative objectives Working PDSAs show the importance of QI skills and methods in planning during COVID-19 -Ideas tested included synchronous video training of teams for Cohort 2 in lieu of in-person training due to COVID-19 SIP PDSAs about system-wide shifts of preventive dentistry into the landscape of tele-dentistry Active testing of workflows for synchronous video dentistry with real-time photos of children's teeth available for dental evaluation along with the use of home kits with toothbrush, toothpaste and Fluoride Varnish packets mailed home before visits show feasibility during COVID-19 SIP and beyond On-going questions to test lie in the realm of coding, billing and receiving, electronic dental records, and video technology linking office providers to patients (2)