Logistics of an advanced therapy medicinal product during COVID-19 pandemic in Italy: successful delivery of mesenchymal stromal cells in dry ice.

BACKGROUND: During the coronavirus disease-2019 (COVID-19) pandemic, Italian hospitals faced the most daunting challenges of their recent history, and only essential therapeutic interventions were feasible. From March to April 2020, the Laboratory of Advanced Cellular Therapies (Vicenza, Italy) received requests to treat a patient with severe COVID-19 and a patient with acute graft-versus-host disease with umbilical cord-derived mesenchymal stromal cells (UC-MSCs). Access to clinics was restricted due to the risk of contagion. Transport of UC-MSCs in liquid nitrogen was unmanageable, leaving shipment in dry ice as the only option. METHODS: We assessed effects of the transition from liquid nitrogen to dry ice on cell viability; apoptosis; phenotype; proliferation; immunomodulation; and clonogenesis; and validated dry ice-based transport of UC-MSCs to clinics. RESULTS: Our results showed no differences in cell functionality related to the two storage conditions, and demonstrated the preservation of immunomodulatory and clonogenic potentials in dry ice. UC-MSCs were successfully delivered to points-of-care, enabling favourable clinical outcomes. CONCLUSIONS: This experience underscores the flexibility of a public cell factory in its adaptation of the logistics of an advanced therapy medicinal product during a public health crisis. Alternative supply chains should be evaluated for other cell products to guarantee delivery during catastrophes.

Barriers to Quality Care in Medical Imaging at a Teaching Hospital in Ghana: Staff Perspective.

BACKGROUND: The goal of quality care is to ensure that the health care services provided to individuals and patient populations improve desired health outcomes. However, as medical imaging services increase in Ghana, empirical evidence show a low level of care. Despite this, there exists no study in the public domain on the barriers to quality care. This study, therefore, sought to identify barriers to quality care in medical imaging at a teaching hospital to provide evidence that will enable optimization of care and in improving the overall medical imaging care delivery system. METHODS: This research was a descriptive, cross-sectional study using a mixed method approach based on the dimensions of quality of care of medical imaging services from medical imaging professionals' perspective: capacity and sustainability, timeliness, safety, equity, patient-centeredness, effective communication, and appropriateness of examination. QUANTITATIVE METHOD: A 5-point Likert scale questionnaire was used. The study population included all medical imaging professionals (n = 47) at the imaging department of the hospital. However, a total of 36 agreed to participate in the study. Data were analyzed using Stata Version 13. Descriptive analyses were carried out. QUALITATIVE METHODS: Purposive sampling strategy was applied to recruit 12 management team members and key staff with vast experience in medical imaging for the study. Data collection was done using a reflective in-depth interview guide. Data were analyzed using thematic analysis. QUANTITATIVE RESULTS: The quantitative findings show more than half of the respondents (n = 23, 63.9%) currently play supervisory roles, 10 (27.8%) work more than 40 hours a week, a minority group (n = 7, 19.4%) examine more than 100 patients per week, and 21 (58.5%) reported quality improvement programs are not carried out. Overall, half (50.0%) of the respondents are unaware of the availability of standard operating procedures, 28 (77.7%) reported imaging machines are not always functional, 34 (94.5%) reported lack of adherence to equipment servicing practices, and 27 (75%) agreed that broken-down equipment are left for more than 3 months before being fixed. In addition, 26 respondents (80.5%) reported staff number is inadequate compared with the workload, whereas only 11 (30.6%) stated supervision by management is adequate. Furthermore, 12 respondents (33.4%) reported management seem interested in quality of care only after adverse event, only 5 (38.5%) of the radiologists stated they are able to meet image reporting deadlines for clients, and only 8 (22.2%) of the respondents reported the availability of means of communicating results to referring clinicians aside the normal report. QUALITATIVE RESULTS: The qualitative findings show a lack of commitment to equipment servicing, frequent nonfunctionality of imaging machines, and an undue delay in repairs of broken-down machines. In addition, there exists inadequate human resource, inadequate supervision, a lack of quality improvement programs, and educational advancement opportunities for staff. The findings further show inadequacy of hospital gowns for patients, a lack of equity, and a poor organizational culture. In addition, the study identified a lack of means of communicating urgent imaging findings and a lack of promptness and timeliness to care from the consultant radiologists. CONCLUSION: The low level of care of medical imaging services observed in Ghana is reflected in the large number of barriers to quality care identified in this study. Most barriers identified are in the capacity and sustainability, timeliness, and effective communication dimensions of quality of care. The findings have important implications for policy makers. Improvement in these areas will enable optimization of care and in improving the overall medical imaging care delivery system.

Trauma Care in India: Capacity Assessment Survey From Five Centers.

BACKGROUND: India is in the process of strengthening the trauma care system, and assessment of the current situation using standard guidelines has immense use. This study reports the status of trauma care facilities in India, with a broad framework of guidelines for essential trauma care by the World Health Organization. MATERIALS AND METHODS: This study is part of a multicentric intervention study to standardize structured trauma care services in five Indian cities. Thirty trauma care facilities (five level I, 10 level II, and 15 level III facilities) were included. Data on the availability of equipment and manpower were collected. Availability of knowledge + skills and equipment + supplies was assessed based on the guidelines for essential trauma care by World Health Organization. RESULTS: There is almost 100% availability of services and equipment in level I hospitals, but availability varied between 50% and 100% at level II facilities. Very fewer number of services are available at level III facilities. Inadequacy of equipment is reported in level II and III facilities. Only level I facilities have required human resources. Availability of resources in terms of knowledge and equipment of different skills indicated that overall optimal level is observed in level I hospitals. Level II facilities are more deficient in nursing and paramedic staff, and level III facilities reported deficiencies in all categories. CONCLUSIONS: A significant imbalance between recommended resources and the resources that are available in the trauma care facilities was noted. Hence, the study warrants urgent strengthening of trauma care facilities, particularly of level II and III facilities.

Assessment of cardiopulmonary resuscitation equipment in resuscitation trolleys in district hospitals in Botswana: A cross-sectional study.

INTRODUCTION: Successful cardiopulmonary resuscitation (CPR) relies, in part, on the availability and the correct functioning of resuscitation equipment. These data are often lacking in resource-constrained African settings. AIM: To assess the availability and the functional status of CPR equipment in resuscitation trolleys at district hospitals in Botswana. SETTING: The study was conducted across four district hospitals in Botswana. METHODS: A cross-sectional study was conducted using a checklist adopted following the Emergency Medical Services of South Africa (EMSSA) guidelines, modified and contextualised to Botswana. RESULTS: All the four district hospitals had inadequate number of CPR equipment available in the resuscitation trolleys. The overall availability of drugs and equipment ranged from 19% to 31.1%. Availability of equipment needed for maintaining circulation and fluids ranged from 27% to 49%, while availability of items for airway and breathing ranged from 9.2% to 24.1%. The overall availability of essential drugs for resuscitation was only 20.4%, and in some wards expired drugs were kept in the trolley. Out of 40 wards that participated in the study, only 10 kept CPR algorithms in the resuscitation trolley. The resuscitation trolley was checked on a daily basis only in the critical care units. CONCLUSION: The resuscitation trolleys were not maintained as per standards. Failure to improve the existing situation could negatively impact the outcome of CPR. Evidence-based standard checklists for resuscitation trolleys need to be enforced to improve the quality of CPR provision in district hospitals in Botswana.

Supply Chains in Healthcare Organizations: Lessons Learned from Recent Shortages.

This paper examines the need for better management of supply chains in healthcare facilities. Recent shortages have highlighted the need for better supply chain systems. The reasons for the shortages are false scarcity, natural disasters, medical lawsuits, production process problems, and group purchasing organizations (GPO). These problems have occurred with increasing frequency. There are three possible solutions available to handle the shortages. First, better use of supply chain management, including multiple suppliers and safety stock. Second, there needs to be better cooperation between suppliers, consumers, and government entities. Finally, healthcare facilities should develop teams of individuals responsible for monitoring critical areas and developing contingency plans.

Clinically Integrated Supply Chain Infrastructure in Health Systems: The Opportunity to Improve Quality and Safety.

Health systems worldwide are challenged by the growing costs and demands of delivering high-quality healthcare services that are safe and cost-effective to support health and wellness for populations. This paper proposes a system-level transformation of clinical environment infrastructure to advance quality and strengthen patient safety at sustainable costs. Evidence of the impact and value of the clinically integrated supply chain strategy is emerging in three global health systems: Alberta Health Services (Canada), Mercy (US) and the National Health Service (UK) to inform a strategic roadmap for health system leaders to leverage supply chain infrastructure in clinical environments as a strategic asset to strengthen quality, safety and cost.

Case Study: Supply Chain Transformation in the UK National Health Service.

This case study provides evidence of the impact of the Scan4Safety program demonstrated in six National Health Service (NHS) Trusts, funded to achieve supply chain transformation to improve safety, quality and performance in the NHS in England. All 154 Trusts were mandated to adopt GS1 global standards for supply chain processes and Pan-European Public Procurement On-Line standards in 2014 to enable digital transactions across the NHS. The outcomes of this case reflect the early implementation of the program infrastructure in surgical theatre and cardiac programs. Outcomes include a 4:1 return on investment and projected savings of £1 billion pounds when scaled across the NHS.

Case Study: Supply Chain Transformation in the Mercy Health System.

The Mercy case study documents evidence of a clinically integrated supply chain strategy implemented in the peri-operative programs in three of the 46 hospitals in the Mercy system. Mercy became the first US health system to achieve "the perfect order," a supply chain industry standard with end-to-end integration of supply chain best practice in the Mercy system. To date, the Mercy strategy has demonstrated revenue growth of $8 billion, a 70% reduction in Never Events, a 33.3% reduction in supplies cost/case and a 29.5% reduction in labour costs/case in the perioperative programs in three hospitals.

[Integral incident management system in primary care: Beyond patient safety]. / Sistema integral de gestión de incidencias en atención primaria: más allá de la seguridad del paciente.

OBJECTIVE: To describe an integral system of notification and management of incidents, created by the Primary Care Team of Guineueta, as well as the main results after 18 months of implementation. MATERIAL AND METHOD: Using a simple online form, health professionals notified any type of, already categorised, incident. Each of them were distributed to an improvement team that assessed and performed the necessary actions. In addition, the Quality Committee immediately assessed the ones that affected patient safety, as well as the most relevant or repetitive ones every 6 months. RESULTS: During the first 18 months of operation of the system, the health professionals reported 1,267 incidents, most notably informatics, maintenance/technical assistance, and errors in scheduling, in internal circuits and protocols. Eight of them were considered to significantly affect patient safety. CONCLUSIONS: The implementation of the described system has been consolidated into our team, facilitating the detection of problems, the accomplishment of improvement actions and involving the professionals in the improvement of the quality.

Review of early assessment models of innovative medical technologies.

INTRODUCTION: Hospitals increasingly make decisions regarding the early development of and investment in technologies, but a formal evaluation model for assisting hospitals early on in assessing the potential of innovative medical technologies is lacking. This article provides an overview of models for early assessment in different health organisations and discusses which models hold most promise for hospital decision makers. METHODS: A scoping review of published studies between 1996 and 2015 was performed using nine databases. The following information was collected: decision context, decision problem, and a description of the early assessment model. RESULTS: 2362 articles were identified and 12 studies fulfilled the inclusion criteria. An additional 12 studies were identified and included in the review by searching reference lists. The majority of the 24 early assessment studies were variants of traditional cost-effectiveness analysis. Around one fourth of the studies presented an evaluation model with a broader focus than cost-effectiveness. Uncertainty was mostly handled by simple sensitivity or scenario analysis. DISCUSSION AND CONCLUSIONS: This review shows that evaluation models using known methods assessing cost-effectiveness are most prevalent in early assessment, but seems ill-suited for early assessment in hospitals. Four models provided some usable elements for the development of a hospital-based model.

Cross-sectional observational assessment of quality of newborn care immediately after birth in health facilities across six sub-Saharan African countries.

OBJECTIVE: To present information on the quality of newborn care services and health facility readiness to provide newborn care in 6 African countries, and to advocate for the improvement of providers' essential newborn care knowledge and skills. DESIGN: Cross-sectional observational health facility assessment. SETTING: Ethiopia, Kenya, Madagascar, Mozambique, Rwanda and Tanzania. PARTICIPANTS: Health workers in 643 facilities. 1016 health workers were interviewed, and 2377 babies were observed in the facilities surveyed. MAIN OUTCOME MEASURES: Indicators of quality of newborn care included (1) provision of immediate essential newborn care: thermal care, hygienic cord care, and early and exclusive initiation of breast feeding; (2) actual and simulated resuscitation of asphyxiated newborn infants; and (3) knowledge of health workers on essential newborn care, including resuscitation. RESULTS: Sterile or clean cord cutting instruments, suction devices, and tables or firm surfaces for resuscitation were commonly available. 80% of newborns were immediately dried after birth and received clean cord care in most of the studied facilities. In all countries assessed, major deficiencies exist for essential newborn care supplies and equipment, as well as for health worker knowledge and performance of key routine newborn care practices, particularly for immediate skin-to-skin contact and breastfeeding initiation. Of newborns who did not cry at birth, 89% either recovered on their own or through active steps taken by the provider through resuscitation with initial stimulation and/or ventilation. 11% of newborns died. Assessment of simulated resuscitation using a NeoNatalie anatomic model showed that less than a third of providers were able to demonstrate ventilation skills correctly. CONCLUSIONS: The findings shared in this paper call attention to the critical need to improve health facility readiness to provide quality newborn care services and to ensure that service providers have the necessary equipment, supplies, knowledge and skills that are critical to save newborn lives.

Innovating affordable neonatal care equipment for use at scale.

The care of small and sick neonates requires biomedical technologies, such as devices that can keep babies warm (radiant warmers and incubators), resuscitate (self-inflating bags), track growth (weighing scales), treat jaundice (phototherapy units) and provide oxygen or respiratory support (hoods, continuous positive airway pressure (CPAP) devices and ventilators). Until the 1990s, most of these products were procured through import at a high cost and with little maintenance support. Emerging demand and an informal collaboration of neonatologists, engineers and entrepreneurs has led to the production of good quality equipment of several high-volume categories at affordable cost in India. Radiant warmers, resuscitation bags, phototherapy units, weighing scales and other devices manufactured by Indian small-scale companies have enabled an expansion of neonatal care in the country, particularly in district hospitals, medical college hospitals and subdistrict facilities in the public sector as a part of the National Rural Health Mission. Indian products have acquired international quality standards and are even exported to developed nations. This paper captures this story of innovation and entrepreneurship in neonatal care.

Acoustic assessment of speech privacy curtains in two nursing units.

Hospitals have complex soundscapes that create challenges to patient care. Extraneous noise and high reverberation rates impair speech intelligibility, which leads to raised voices. In an unintended spiral, the increasing noise may result in diminished speech privacy, as people speak loudly to be heard over the din. The products available to improve hospital soundscapes include construction materials that absorb sound (acoustic ceiling tiles, carpet, wall insulation) and reduce reverberation rates. Enhanced privacy curtains are now available and offer potential for a relatively simple way to improve speech privacy and speech intelligibility by absorbing sound at the hospital patient's bedside. Acoustic assessments were performed over 2 days on two nursing units with a similar design in the same hospital. One unit was built with the 1970s' standard hospital construction and the other was newly refurbished (2013) with sound-absorbing features. In addition, we determined the effect of an enhanced privacy curtain versus standard privacy curtains using acoustic measures of speech privacy and speech intelligibility indexes. Privacy curtains provided auditory protection for the patients. In general, that protection was increased by the use of enhanced privacy curtains. On an average, the enhanced curtain improved sound absorption from 20% to 30%; however, there was considerable variability, depending on the configuration of the rooms tested. Enhanced privacy curtains provide measureable improvement to the acoustics of patient rooms but cannot overcome larger acoustic design issues. To shorten reverberation time, additional absorption, and compact and more fragmented nursing unit floor plate shapes should be considered.

Readiness of Health Centers and Primary Hospitals for the Implementation of Proposed Health Insurance Schemes in Southwest Ethiopia.

BACKGROUND: In response to the 2005 World Health Assembly, many low income countries developed different healthcare financing mechanisms with risk pooling stategy to ensure universal coverage of health services. Accordingly, service availability and readiness of the health system to bear the responsibility of providing service have critical importance. The objective of this study was to assess service availability and readiness of health centers and primary hospitals to bear the responsibility of providing service for the members of health insurance schemes. METHODS AND MATERIALS: A facility based cross sectional study design with quantitative data collection methods was employed. Of the total 18 districts in Jimma Zone, 6(33.3%) districts were selected randomly. In the selected districts, there were 21 functional public health facilities (health centers and primary hospitals) which were included in the study. Data were collected by interviewer administered questionnaire. Descriptive statistics were calculated by using SPSS version 20.0. Prior to data collection, ethical clearance was obtained. RESULTS: Among the total 21 public health facilities surveyed, only 38.1% had all the categories of health professionals as compared to the national standards. The majority, 85.2%, of the facilities fulfilled the criteria for basic equipment, but 47.7% of the facilities did not fulfill the criteria for infection prevention supplies. Moreover, only two facilities fulfilled the criteria for laboratory services, and 95.2% of the facilities had no units/departmenst to coordinate the health insurance schemes. CONCLUSIONS: More than nine out of ten facilities did not fulfill the criteria for providing healthcare services for insurance beneficiaries and are not ready to provide general services according to the standard. Hence, policy makers and implementers should devise strategies to fill the identified gaps for successful and sustainable implementation of the proposed insurance scheme.

Evidence-Based and Value-Based Decision Making About Healthcare Design: An Economic Evaluation of the Safety and Quality Outcomes.

OBJECTIVE: This study describes a vision and framework that can facilitate the implementation of evidence-based design (EBD), scientific knowledge base into the process of the design, construction, and operation of healthcare facilities and clarify the related safety and quality outcomes for the stakeholders. The proposed framework pairs EBD with value-driven decision making and aims to improve communication among stakeholders by providing a common analytical language. BACKGROUND: Recent EBD research indicates that the design and operation of healthcare facilities contribute to an organization's operational success by improving safety, quality, and efficiency. However, because little information is available about the financial returns of evidence-based investments, such investments are readily eliminated during the capital-investment decision-making process. METHOD: To model the proposed framework, we used engineering economy tools to evaluate the return on investments in six successful cases, identified by a literature review, in which facility design and operation interventions resulted in reductions in hospital-acquired infections, patient falls, staff injuries, and patient anxiety. RESULTS: In the evidence-based cases, calculated net present values, internal rates of return, and payback periods indicated that the long-term benefits of interventions substantially outweighed the intervention costs. This article explained a framework to develop a research-based and value-based communication language on specific interventions along the planning, design and construction, operation, and evaluation stages. CONCLUSIONS: Evidence-based and value-based design frameworks can be applied to communicate the life-cycle costs and savings of EBD interventions to stakeholders, thereby contributing to more informed decision makings and the optimization of healthcare infrastructures.

The study of the optimal parameter settings in a hospital supply chain system in Taiwan.

This study proposed the optimal parameter settings for the hospital supply chain system (HSCS) when either the total system cost (TSC) or patient safety level (PSL) (or both simultaneously) was considered as the measure of the HSCS's performance. Four parameters were considered in the HSCS: safety stock, maximum inventory level, transportation capacity, and the reliability of the HSCS. A full-factor experimental design was used to simulate an HSCS for the purpose of collecting data. The response surface method (RSM) was used to construct the regression model, and a genetic algorithm (GA) was applied to obtain the optimal parameter settings for the HSCS. The results show that the best method of obtaining the optimal parameter settings for the HSCS is the simultaneous consideration of both the TSC and the PSL to measure performance. Also, the results of sensitivity analysis based on the optimal parameter settings were used to derive adjustable strategies for the decision-makers.