The evolving regulatory landscape in regenerative medicine.

Regenerative medicine as a field has emerged as a new component of modern medicine and medical research that encompasses a wide range of products including cellular and acellular therapies. As this new field emerged, regulatory agencies like the Food and Drug Administration (FDA) rapidly adapted existing regulatory frameworks to address the transplantation, gene therapy, cell-based therapeutics, and acellular biologics that fall under the broader regenerative medicine umbrella. Where it has not been possible to modify existing regulation and processes, entirely new frameworks have been generated with the intention of providing flexible, forward-facing systems to regulate this rapidly growing field. This review discusses the current state of FDA regulatory affairs in the context of stem cells and extracellular vesicles by highlighting gaps in the current regulatory system and then discussing where regulatory science in regenerative medicine may be headed based on these gaps and the FDA's historical ability to deal with emerging fields. Lastly, we utilize case studies in stem cell and acellular based treatments to demonstrate how regulatory science has evolved in regenerative medicine and highlight the ongoing clinical efforts and challenges of these therapies.

Usage of Regular Safety Surveys to Assess and Improve Safety Culture in the Radiation Treatment Department

Aim: The Radiation Treatment Quality Assurance Committee (RTQAC) is a multidisciplinary committee within the Radiation Treatment department. As a newly established committee in 2013, the RTQAC had a desire to obtain feedback from staff and to evaluate the existing safety culture. Safety culture surveys have been continued with the aim to assess and improve the safety culture within our department. Process: The RTQAC has since completed six safety culture surveys. The surveys have ranged from 9-15 questions in length with the most recent one sent in 2021. Some questions were edited or modified with each survey as the committee saw fit. The surveys were sent to all current staff across various disciplines in the Radiation Treatment department. Themes have emerged over the years as with some general categories, including: Reporting Program, Barriers to Reporting, Communication and Discussion of Incidents and Suggestions for Improving Quality and Safety. Results are collected and analyzed in comparison with previous results and are shared with the department in a summarizing report. Benefits/Challenges: Regular collection of safety culture survey results have highlighted successes within the department and the RTQAC. It has provided staff an opportunity to talk openly and anonymously about safety concerns. Themes emerging from results have provided content for group discussion and review of potential areas of improvement. Opportunities for education in the department have been highlighted. The results have also allowed the RTQAC to reflect on the scope of the committee tasks. One consistent challenge faced has been the low number of respondents, which limits creation of conclusions and potential suggestions or recommendations. There can also be a great deal of time associated with reviewing a large number of comments. The committee takes all comments seriously and some negative comments can be difficult to read. Impact/Outcomes: The implementation of safety culture surveys in our department has proven invaluable. It has allowed the committee to obtain current opinions about safety culture and incident learning processes given that these are dynamic and changing over time. Trends, both positive and negative, have been observed over the last 8 years. Safety culture is something that has to be constantly evolving as it can change with various staff and external challenges such as COVID-19. Copyright © 2022

Usage of Regular Safety Surveys to Evaluate and Strengthen Safety Culture in the Radiation Treatment Department

Purpose: The Radiation Treatment Quality Assurance Committee (RTQAC) is a multidisciplinary committee within the Radiation Treatment department. As a newly established committee in 2013, the RTQAC had a desire to obtain feedback from staff and to evaluate the existing safety culture. This practice has continued in subsequent years, with six surveys conducted over an 8-year period. The purpose of the safety culture surveys is to measure staff comfort with reporting incidents and the informationgathering process which follow an incident, to gather staff feedback on ways to improve the quality of treatment delivery, to measure and assess the current state of the safety culture in the department, and to identify themes from the results to drive quality improvement initiatives. Material(s) and Method(s): The safety culture surveys are developed in an electronic format and have been sent to all staff across various disciplines in the Radiation Treatment department, including radiation oncologists, medical physicists, physics associates, electronics engineers, radiation therapists, nurses, and clerical staff. The most recent survey was conducted in 2021. The surveys have ranged from nine to fifteen questions in length. Many of the questions have remained the same across the years, while some have been modified with each survey as seen fit by the committee. Responses are collected in both a multiple-choice format as well as written responses. Responses collected from each survey are analyzed, and when possible, compared against similar questions asked in previous years. The results are compiled into a report which is shared with the department. Result(s): Safety culture is something that is dynamic, as it can change with the implementation of new procedures, updates to incident reporting systems, changes in staffing, and external challenges such as COVID-19. Regular collection of safety culture survey results have highlighted both successes and areas of improvement within the department and the RTQAC. While in many areas, trends are positive, those areas which illustrate progressively negative responses have identified common issues which can be addressed. Feedback that has been collected has subsequently helped guide quality improvement initiatives. Conclusion(s): The implementation of safety culture surveys in our department has proven invaluable. It has provided staff an opportunity to talk openly and anonymously about safety concerns. Through assessment of responses, quality improvement strategies can be undertaken, which in turn can advance the culture of safety in the program. Copyright © 2022 Elsevier Ireland Ltd. This is an open access article under the CC-BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

OLDER PERSON’S ASSESSMENT SERVICE (OPAS): DELIVERING COMPREHENSIVE GERIATRIC ASSESSMENT (CGA) IN THE EMERGENCY DEPARTMENT (ED)

Introduction Innovative models of service delivery are required to provide Comprehensive Geriatric Assessment for older patients presenting to the Emergency Department with frailty syndromes. Method In 2018, the Older Person’s Assessment Service began a liaison service to the ED, taking referrals from the medical and ED teams for patients who presented with frailty syndromes (falls, cognitive impairment, care dependence, polypharmacy). The service saw 437 patients April–August 2018. 76% of the patients assessed were discharged by utilising available community services, rapid access outpatient follow up and inpatient reablement off the acute site. The service was estimated to avoid 50–80 admissions per month to medicine (saving 17–23 beds a year) and was commissioned as a permanent service. Phase 2 In 2020, a dedicated unit within ED was allocated to OPAS, enabling the acceptance of patients directly from triage and from the Ambulance Service by direct referral. This provided rapid access to specialist assessment, continued access to Elderly Care services, avoided exposure to coronavirus related admissions and the risks of nosocomial infection associated with admission. The service operates from 8 am-4 pm on weekdays. Results Between June 2020 and October 2021, the service saw 1,173 new patients. 988 patients (84.5%) were discharged off the acute site on the day of assessment. 68 (5.79%) patients were admitted to other facilities run by the Health Board (e.g Inpatient Reablement). The average age of an OPAS patient was 83 yrs and had a CFS > 5. Readmission rate at 14 days was 4% (47).Of the 253 patients who were admitted to an inpatient setting, 13.5% (35) contracted nosocomial covid-19. Conclusion The service has been supported and funded to expand into extended weekday hours as a result of this success and there are plans for future 7 day working.

Hyperglycaemia to the extremes and the complex challenges

A 28-year- old Afro-Caribbean gentlemen with a body mass index of 28.5 kg/m2 presented with a 2-week history of osmotic symptoms and was found to have a glucose of > 122 mmol/L. His medical history includes a SARS-CoV- 2 infection 6 months prior. On presentation, plasma ketones were >7 mmol/L, sodium 126 mmol/L, potassium 4.3 mmol/L, pH 7.09 with an osmolality of 450 mOsmol. In the emergency department, he was treated initially with intravenous sodium chloride and intravenous insulin following diabetic ketoacidosis protocol. Insulin dosing was reduced to a requirement of 1-2 units per hour alongside a dextrose infusion to maintain a glucose level around 40 mmol/L. This was done for the first forty eight hours to avoid the over-rapid correction of glucose and subsequent over rapid correction of osmolality. Ketones were deescalated to <1 mmol/L within eight hours. Following initial treatment, severe hypokalaemia occurred requiring significant potassium replacement up to 400 mmols over seven hours. Treatment dose low molecular weight heparin was used to prevent thrombotic complications. The clinical course was complicated by rhabdomyolysis (creatine kinase 81,573 IU/L), hypocalcaemia (1.94 mmol/L) which was cautiously replaced, pancreatitis (amylase 776 IU/L), acute kidney injury requiring haemoflitration for seven days and stress-induced duodenal ulceration causing malaena. This case was particularly challenging due to the extremely high blood glucose levels coexisting with very high ketones, resulting in acid base and electrolyte abnormalities;the normal potassium in the context of significant acidosis can disguise the true potassium levels. The patient made a full recovery.