scholarly journals Process Surveillance and Follow-Up Monitoring to Increase Compliance to Standards in Medical Device Reprocessing

2020 ◽  
Vol 41 (S1) ◽  
pp. s360-s360
Author(s):  
Mark Scott ◽  
Sharon Wilson ◽  
Kathryn Bush ◽  
Control ◽  
Karin Fluet ◽  
...  
Keyword(s):  
Patient Safety ◽  
Health Services ◽  
Health System ◽  
Medical Device ◽  
Review Process ◽  
Resolution Rate ◽  
Physical Infrastructure ◽  
Corrective Actions ◽  
Medical Device Reprocessing

Background: Effective medical device reprocessing (MDR) is essential in preventing the spread of microorganisms and maintaining patient safety. Alberta Health Services (AHS) is an Alberta-wide, integrated health system, responsible for delivering health services to >4.3 million people living in the province. In 2010, periodic province-wide MDR reviews were initiated by the provincial health system to verify that the cleaning, disinfection, and sterilization of reusable critical and semicritical medical devices met established standards. To date, there have been 3 review cycles; in cycle 3, a follow-up process for tracking and reporting corrective actions was initiated. Methods: As in previous MDR review cycles, cycle 3 included the use of a standardized suite of tools to measure compliance with standards set by Accreditation Canada, the Canadian Standards Association, and the Government of Alberta. Each cycle involved a review of MDR areas completed by trained reviewers. Interrater reliability among reviewers was maintained through training and debriefings following reviews to ensure agreement. Following reviews, reports were generated for areas, zones, and AHS. As part of the corrective actions and follow-up process, identified deficiencies were categorized into 5 themes. Corrective actions were tracked and periodic reports were generated showing the progress of deficiency resolution. Resolution rates (number of resolved deficiencies divided by total number of of deficiencies) were calculated for each of the identified themes as well as overall for cycle 3. Results: Overall compliance for cycle 3 was 93%. Cycle 3 reviews revealed that more than half of the deficiencies (58%) were identified previously in cycle 2. The resolution rates ranged from 78% to 95% for identified deficiencies for 4 of the 5 themes: documentation, technique, PPE/attire/hand hygiene, and other. The theme related to physical infrastructure showed a considerably lower resolution rate of 49%. The corrective action follow-up process showed increased overall resolution rate from 59% at the start of the follow-up process to 82% at its completion. When this resolution rate was applied to the initial survey compliance rate for cycle 3, overall compliance increased to 99%. Conclusions: Monitoring quality of MDR practices is essential in maintaining and improving patient safety. The standardized provincial review process identified common themes and a coordinated approach to support the resolution of many identified deficiencies. Most of those deficiencies were resolved; however, those deficiencies related to physical infrastructure of the MDR department continue to be seen across review cycles. This review process with follow up of these deficiencies can help bring attention to organization leadership and Funding: authorities during budget cycles.Funding: NoneDisclosures: None

scholarly journals The Role of Patient Navigators in Ambulatory Care: Overview of Systematic Reviews

2021 ◽  
Author(s):  
Hannah Budde ◽  
Gemma Williams ◽  
Juliane Winkelmann ◽  
Laura Pfirter ◽  
Claudia Bettina Maier
Keyword(s):  
Health Services ◽  
Health System ◽  
Ambulatory Care ◽  
Systematic Reviews ◽  
Patient Navigation ◽  
Transitional Care ◽  
Emergency Department Visits ◽  
Patient Navigators

Abstract Background: Patient navigators have been introduced across various countries to enable timely access to healthcare services and ensure completion of diagnosis and follow-up of care. There is an increasing amount of evidence on the positive effect of patient navigation for patients. The aim of this study was to analyse the evidence on patient navigation interventions in ambulatory care and to evaluate their effects on individuals and health system outcomes.Methods: An overview of reviews was conducted, based on a prespecified protocol. All patients in ambulatory care or transitional care setting were included in this review as long as it was related to the role of patient navigators. The study analysed all roles of patient navigators covering a wide range of health professionals such as physicians, nurses, pharmacists, social workers as well as lay health workers or community-based workers with no or very limited training. Studies including patient-related measures and health system-related outcomes were eligible for inclusion. A rigorous data collection was performed in multiple data bases. After reaching an inter-rater agreement, title and abstract screening was independently performed. Of an initial 8362 search results a total of 673 articles were eligible for full-text screening. An extraction form was used to analyse the nine included review.Results: Nine systematic reviews were included covering various patient navigation roles in cancer care, disease screening and transitional care. Seven systematic reviews primarily tailored services to ethnic minorities or other disadvantaged groups. Patient navigators performed tasks such as providing education and counselling, translations, home visits, outreach, scheduling of appointments and follow-up. Six reviews identified positive outcomes in expanding access to care, in particular for vulnerable patient groups. Two reviews on patient navigation in transitional care reported improved patient outcomes and hospital readmission rates and mixed evidence on quality of life and emergency department visits.Conclusions: Patient navigators have shown to expand access to screenings and health services for vulnerable patients or population groups who tend to underuse health services.

Analysis of FDA Warning Letters Issued to Indian Pharmaceutical and Medical Device Companies: A Retrospective Study

2019 ◽  
pp. 216847901987938
Author(s):  
Shray Bablani ◽  
Manthan D. Janodia
Keyword(s):  
Retrospective Study ◽  
Medical Device ◽  
Pharmaceutical Products ◽  
Pharmaceutical Companies ◽  
Federal Regulations ◽  
Public Database ◽  
Pharmaceutical Manufacturers ◽  
Medical Device Manufacturers ◽  
Corrective Actions

Background: FDA issues warning letters to pharmaceutical manufacturers, distributors, or clinical investigators if it observes serious violations of federal regulations. These warning letters contain the details about the nature of the violations observed and the corrective actions recommended by the FDA. A follow-up inspection may be requested by the recipient after taking the corrective actions. Methods: Analysis of warning letters issued to Indian pharmaceutical companies from January 1, 2005, to December 31, 2018, was carried out. The warning letters were extracted from FDA’s public database. Results: Across the 14-year study period, the number of warning letters issued to Indian pharmaceutical and medical device manufacturers has gradually increased. Of all the violations listed in these warning letters, 85.87% were related to the failure of compliance with the cGMP guidelines. Moreover, 80.72% of these warning letters were not followed by a close-out warning, which indicated that the violations listed in these warning letters could not be resolved. Conclusion: As the inability of the recipients to comply with the cGMP guidelines formed the majority of the violations observed in the warning letters, more resources and manpower have to be assigned to the manufacturing process of the pharmaceutical products.

Multi-level Barriers for Utilization of Youth Friendly Reproductive Health Services (YFRHS) among Youths

2020 ◽  
Vol 8 ◽  
pp. 95-108
Author(s):  
Shanti Prasad Khanal
Keyword(s):  
Reproductive Health ◽  
Health Services ◽  
Health System ◽  
System Level ◽  
Mixed Method Research ◽  
Reproductive Health Services ◽  
Group Discussions ◽  
Personal Level ◽  
Multi Level ◽  
Youth Friendly

 The present study aims to examine the multi-level barriers to utilize by the youth-friendly reproductive health services (YFRHS) among the school-going youths of the Surkhet valley of Nepal. This study is based on the sequential explanatory research design under mixed-method research. The quantitative data were collected using the self- administered questionnaire from the 249 youths, aged between the 15-24 years, those selected by using random sampling. The qualitative data were collected using the Focus Group Discussions (FGDs) from the 12 participants who were selected purposively. The study confirmed that school-going youths do not have appropriate utilization of YFHS due to multi-layered barriers. However, the utilization of the service was higher among females, those the older age group, studying in the upper classes, the upper castes, and married youths. The key findings and themes are recognized as multi-layered barriers including personal-level, health system-level, community-level, and policy-level on the entire socio-ecological field. Among them, the existing health system is the foremost barrier. Multi-level interventions are, therefore, required to increase the YFRHS utilization and improve concerns for school-going-youths.  

Effects and utility of an online forward triage tool during the SARS-CoV-2 pandemic: patient perspectives (Preprint)

2020 ◽  
Author(s):  
Janet Michel
Keyword(s):  
Decision Making ◽  
Health System ◽  
Information Source ◽  
Patient Perspectives ◽  
User Friendliness ◽  
Fear And Anxiety ◽  
Mail Address ◽  
Second Wave ◽  
E Mail

BACKGROUND Background: Online forward triage tools (OFTT) or symptom checkers are being widely used during this COVID-19 pandemic. The effects and utility of such tools however, have not been widely assessed. OBJECTIVE Objective: To assess the effects (quantitatively) and the utility (qualitatively) of a COVID-19 OFTT in a pandemic context, exploring patient perspectives as well as eliciting recommendations for tool improvement. METHODS Methods: We employed a mixed-method sequential explanatory study design. Quantitative data of all users of the OFTT between March 2nd, 2020 and May 12th, 2020 were collected. A follow-up survey of people who consented to participation was conducted. Secondly, qualitative data was collected through key informant interviews (n=19) to explain the quantitative findings, as well as explore tool utility, user experience and elicit recommendations. RESULTS Results: An estimate of the effects, (quantitatively) and the utility (qualitatively) of a COVID-19 OFTT in a pandemic context, and recommendations for tool improvement. In the study period, 6,272 users consulted our OFTT; 560 participants consented to a follow-up survey and provided a valid e-mail address. 176 (31.4%) participants returned a complete follow-up questionnaire. 85.2% followed the recommendations given. 41.5% reported that their fear was allayed after using tool and 41.1% would have contacted the GP or visited a hospital had the tool not existed. Qualitatively, seven overarching themes emerged namely i) accessibility of tool, ii) user-friendliness of tool, iii) utility of tool as an information source, iv) utility of tool in allaying fear and anxiety, v) utility of tool in decision making (test or not to test), vi) utility of tool in reducing the potential for onward transmissions (preventing cross infection) and vii) utility of tool in reducing health system burden. CONCLUSIONS Conclusion: Our findings demonstrated that a COVID-19 OFTT does not only reduce the health system burden, but can also serve as an information source, reduce anxiety and fear, reduce cross infections and facilitate decision making (to test or not to test). Further studies are needed to assess the transferability of these COVID-19 OFTT findings to other contexts as the second wave sweeps across Europe.

scholarly journals The Family Psychoeducation Fidelity Scale: Psychometric Properties

2020 ◽  
Vol 47 (6) ◽  
pp. 894-900 ◽  
Author(s):  
I. Joa ◽  
J. O. Johannessen ◽  
K. S. Heiervang ◽  
A. A. Sviland ◽  
H. A. Nordin ◽  
...  
Keyword(s):  
Psychometric Properties ◽  
Internal Consistency ◽  
Interrater Reliability ◽  
Review Process ◽  
Trial Registration ◽  
Family Psychoeducation ◽  
Time Points ◽  
The Family ◽  
Fidelity Scale

Abstract This study examined psychometric properties and feasibility of the Family Psychoeducation (FPE) Fidelity Scale. Fidelity assessors conducted reviews using the FPE fidelity scale four times over 18 months at five sites in Norway. After completing fidelity reviews, assessors rated feasibility of the fidelity review process. The FPE fidelity scale showed excellent interrater reliability (.99), interrater item agreement (88%), and internal consistency (mean = .84 across four time points). By the 18-month follow-up, all five sites increased fidelity and three reached adequate fidelity. Fidelity assessors rated feasibility as excellent. The FPE fidelity scale has good psychometric properties and is feasible for evaluating the implementation of FPE programs. Trial registration ClinicalTrials.gov Identifier: NCT03271242.

scholarly journals A comparison of zero-inflated and hurdle models for modeling zero-inflated count data

2021 ◽  
Vol 8 (1) ◽  
Author(s):  
Cindy Xin Feng
Keyword(s):  
Health Services ◽  
Count Data ◽  
Goodness Of Fit ◽  
Negative Binomial ◽  
Simulation Studies ◽  
Final Choice ◽  
Hurdle Models ◽  
Count Distribution ◽  
Careful Assessment

AbstractCounts data with excessive zeros are frequently encountered in practice. For example, the number of health services visits often includes many zeros representing the patients with no utilization during a follow-up time. A common feature of this type of data is that the count measure tends to have excessive zero beyond a common count distribution can accommodate, such as Poisson or negative binomial. Zero-inflated or hurdle models are often used to fit such data. Despite the increasing popularity of ZI and hurdle models, there is still a lack of investigation of the fundamental differences between these two types of models. In this article, we reviewed the zero-inflated and hurdle models and highlighted their differences in terms of their data generating processes. We also conducted simulation studies to evaluate the performances of both types of models. The final choice of regression model should be made after a careful assessment of goodness of fit and should be tailored to a particular data in question.

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