Provider issues related to patient controlled analgesia and nurse controlled analgesia errors in a pediatric hospital

Background: Medical errors are a danger to patient safety and a significant cause of morbidity and mortality. Additionally, they increase expenditures in an already significantly indebted U.S. health care system. Much confusion exists about definitions of medical errors, which include medication errors and adverse drug events (ADEs). Several federal and international organizations have attempted to standardize definitions in order to streamline data collection, but until these standards are universally adopted, error reports and trends are still subject to questions of validity. Reporting errors, in general, has become a more socially acceptable practice in health care with the advent of several anonymous reporting databases. There have also been several initiatives aimed at reducing the incidence of errors, which range from national programs to intrafacility guidelines. Several pieces of health information technology (HIT) have made an impact on error incidence and data collection, although there is much room for improvement. Patient controlled analgesia (PCA) pumps for pain management have been in existence for decades, and "smart pump" software has improved their safety and ease of programming. PCA use in children presents challenges to clinicians, and the characteristics of providers who write PCA orders and those who program PCA pumps may play a role in the incidence of events related to PCA. This study seeks to elucidate trends in errors as they related to these different PCA providers in a pediatric hospital in the northeastern U.S. and provide recommendations for how PCA practice can be improved in this facility. Methods: Safety Event Reporting System (SERS) reports of PCA events (n = 117) during the period of 2004 - 2012 were analyzed retrospectively to determine several key variables for data analysis. The main focus of this analysis was those variable trends related to providers, including: proportion of events caused by human error, proportion of events related to subcategories of human error, proportion of types of prescribers involved in PCA events, proportion of errors in medical and surgical patients, proportion of errors occurring on day and night shifts for the nursing staff, and proportion of events that were dosing mistakes. Statistical analysis was performed for these results when possible to determine significance. Results: Human errors were implicated in 84.1% of events, whereas PCA pump mechanical errors and software errors were implicated in 7.1% and 7.9% of events, respectively. Statistically significant differences were found in all variables tested, including the proportion of nursing errors (60.9%) versus prescriber errors (28.7%) (p < 0.0002). For types of prescribers, the proportion of PCA events occurring when a M.D. wrote the PCA order (56.41%) was statistically different than when a N.P. wrote the PCA order (39.32%) (p = 0.0129). More surgical patients (61.5%) were affected by PCA events than medical patients (36.8%) (p < 0.0002). There were more events occurring on the nursing staff day shift (59.8%) than the night shift (36.8%) (p = 0.0004). Finally, dosing mistakes (66.7%) were implicated in significantly more PCA events than any other error type (33.3%) (p < 0.0002). Conclusion: Several recommendations for improving the safety of PCA in pediatric pain management are justified by the results of this data analysis. First, further education and simulation for entering PCA orders into the CPOE system is needed for all prescribers. Secondly, further education and simulation in PCA pump programming and system set-up is needed for all nursing staff members. In regard to prescriber credentials, it is recommended that Pain Treatment Service (PTS) staff members train M.D. residents in writing PCA orders and entering them into the CPOE system. Finally, it is recommended that the SERS management team publish standardized error report content and entry format in order to streamline data analysis for quality improvement (QI) purposes

New Product Development Processes for IOT-Enabled Home Use Medical Devices: A Systematic Review

Background: In the new forefront of healthcare at patients’ homes, medical devices developed to use at home setting by lay users are essential. The adoption of home-use medical devices will benefit both patients and public healthcare services in terms of quality of life, enhanced outcomes, and reduced cost of care. Home use medical devices associated with Internet-Of-Things (IOT) technology assists patients in performing self-care as well as providing health information remotely to health care professionals. However, adopting technology requires understanding the nature of the medical device and medical device development (MDD). Existing studies concerning the new product development (NPD) processes or design processes were systematically reviewed to explore knowledge and expertise to provide a framework for IOT engineers or designers to adopt IOT technology to home use medical devices. Objective: This study aimed to review the published literature to explore the current studies in the field of the NPD process, design process, design methodology, and outcome of the device affecting user acceptance. Methods: A systematic review following PRISMA guidelines of the English language literature from four electronic databases and academic search engines published from 2007 to 2018 was conducted. The papers were screened and assessed following predefined inclusive and exclusive criteria. The results were analyzed according to the research questions. Results: The findings revealed state-of-the-art in the NPD process and design process (n=4), the design methodology (n=23), and the resultant outcomes of empirical or clinical research in the validation stage (n=14) of medical device development (MDD). The findings also delineated existing studies in NPD, design process, and design methodologies aimed to ensure that medical devices would be effective and safe. Human factor engineering (HFE), cognitive method, ethnographic, and other methodologies were proposed to understand users, uses and context of use. Barriers, constraints, and multidisciplinary communication were addressed. Tools, processes, and methodologies were proposed to overcome the barriers. Conclusion: As home-use medical device development (MDD) and the adoption of IOT technology is now at a crossroads. This study addresses the necessity for future academic studies related to IOT adoption to MDD, including unique risks, multidisciplinary problems, emerging from IOT technology. Finally, future studies aimed at fabricating the NPD process or design process for IOT home-use medical devices to gain user acceptance were outlined

A methodology to systematically analyze the hospital discharge of terminally ill patients

To provide an appropriate method to systematically analyze the hospital discharge of terminally ill patients especially the cooperation between hospital and community nurses and the quality of the discharge handovers. To evaluate the hospital discharge process of terminally ill patients in an academic hospital in the Netherlands using the proposed method. Data were collected from a prospective cohort of all terminally ill patients discharged from the University Medical Center Groningen, the Netherlands, between June and November 2014. The hospital discharges were assessed using 2 questionnaires: an inventory questionnaire, to determine the required care, and an evaluation questionnaire, to evaluate the care actually organized and the discharge handovers. The inventory questionnaire was completed prior to discharge and the evaluation questionnaire between 3 to 7 days after discharge. Around 130 consecutive patients were included. The discharge took place on the desired date in 86% of cases and the average overall discharge grade on a 10-point scale was 7.4 (range: 3-9.5). In 23% of cases discrepancies between required and provided care were identified and medication queries existed in 29%. This study provides a methodology to analyze the hospital discharge procedure of terminally ill patients that can be utlized in any hospital. Structured analysis of the discharge process is valuable and identifies where improvements can be made. Within the study cohort the home care could be arranged at short notice and was considered sufficient. However, in a significant proportion of patients a discrepancy between required and arranged care and queries about medication were identified

Master of Science

thesisThough medical advances in the last century now allow us to forestall death, many patients suffer from significant symptoms as they battle severe disease. Opioid medications are particularly effective when treating pain in these patients and infusion by the patient controlled analgesia (PCA) paradigm is commonly used in patients with severe disease. While PCA allows rapid titration yet individualized adjustment of opioid dose, it involves complex, high-stakes decisions. Unfortunately, clinicians complain that it is often difficult or impossible to find the data needed to make these decisions. A relevant data display could support clinical decisions by providing real-time up-to-date clinical data at the point of care. Literature synthesis and multiple modeling techniques were used to quantify the domain. An inductive, qualitative approach, including graphical mapping techniques, was used to build a foundational domain information model which was subsequently validated using a survey of domain experts. A gap analysis was performed, mapping concepts from the information model to the emerging HL7 FHIR standard. Modeling revealed a complex workflow, highlighted the bottleneck in information flow to providers at the point of care, and supported the premise that a relevant data display would be beneficial. The gap analysis showed that currently existing FHIR resources are capable of representing all relevant concepts from the domain information model needed for decision making in this complex use-case. Potential problems with FHIR implementation were identified and recommendations to address these are presented

Safety of Patient-Controlled Analgesia After Surgery in Children And Adolescents: Concerns And Potential Solutions

Patient-controlled analgesia (PCA) is common practice for acute postoperative pain management. Postoperative PCA use decreases pain intensity and improves patient satisfaction when compared to non-PCA routes of medication administration. Although PCA has several advantages regarding efficacy and safety, adverse events remain a concern. Programming errors and protocols, patient monitoring, and PCA by proxy or with continuous infusion are recurring silent dangers of PCA use in children and adolescents. Innovative considerations need to be emphasized for future improvement of PCA devices for elective surgical patients. With technology within the healthcare setting advancing at a fast pace, smart pump technology is something to look forward to

Medical Device Interoperability With Provable Safety Properties

Applications that can communicate with and control multiple medical devices have the potential to radically improve patient safety and the effectiveness of medical treatment. Medical device interoperability requires devices to have an open, standards-based interface that allows communication with any other device that implements the same interface. This will enable applications and functionality that can improve patient safety and outcomes. To build interoperable systems, we need to match up the capabilities of the medical devices with the needs of the application. An application that requires heart rate as an input and provides a control signal to an infusion pump requires a source of heart rate and a pump that will accept the control signal. We present means for devices to describe their capabilities and a methodology for automatically checking an application’s device requirements against the device capabilities. If such applications are going to be used for patient care, there needs to be convincing proof of their safety. The safety of a medical device is closely tied to its intended use and use environment. Medical device manufacturers create a hazard analysis of their device, where they explore the hazards associated with its intended use. We describe hazard analysis for interoperable devices and how to create system safety properties from these hazard analyses. The use environment of the application includes the application, connected devices, patient, and clinical workflow. The patient model is specific to each application and represents the patient’s response to treatment. We introduce Clinical Application Modeling Language (CAML), based on Extended Finite State Machines, and use model checking to test safety properties from the hazard analysis against the parallel composition of the application, patient model, clinical workflow, and the device models of connected devices

An Evaluation of Implementing Enhanced Recovery After Surgery Protocol Throughout the Perioperative Phase: A Quality Improvement Initiative to Enhance Patient Outcomes After Colorectal Surgery

Abstract: The Enhanced Recovery After Surgery protocol (ERAS) is a multimodal collaborative approach implemented throughout the perioperative phase to enhance patient outcomes. The key mechanism for effectiveness in the ERAS protocol is the attenuation of the surgical stress response combined with treatments that support the return of functions that delay recovery in traditional methods. The purpose of this scholarly project was to evaluate the results of the ERAS Pilot program currently initiated at Baptist Memorial Hospital to improve patient outcomes undergoing major abdominal surgery. Prior to the implementation of the ERAS protocol there was no standardized method in place at this institution to improve patient recovery. There was monthly educational in-services pertaining to ERAS guidelines provided to healthcare providers taking care of ERAS patients in order to increase the levels of compliance with protocol orders. A retrospective chart review was conducted evaluating average length of stay, return of bowel function, opioid consumption, pain scores, patient satisfaction, and postoperative surgical complications in ERAS versus non-ERAS patients undergoing major abdominal surgery to measure the effectiveness of the ERAS protocol at Baptist Memorial Hospital

The anaesthetic management of patients undergoing caesarean section surgery and its impact on post-operative analgesia

A Thesis submitted to the Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, in fulfilment of the requirements for the degree of Doctor of Philosophy. 14th October 2016 in JohannesburgPoorly controlled pain following caesarean section surgery can have a debilitating effect on the physical and emotional well being of a woman during the post-operative period. Good intra-operative anaesthetic management during caesarean section surgery is requisite to improve post-operative analgesia, and thereby contribute to the well being of the patient. In South Africa (SA) there are currently no national obstetric anaesthesia practice guidelines. Anaesthetic service providers therefore rely on knowledge acquired during their anaesthetic training and recommendations from international guidelines (which may not be applicable in SA). In order to establish a reference standard of anaesthetic care for obstetric patients in SA, a semi-structured interview was conducted with the heads of department and/or their representatives from the eight anaesthesiology academic departments in SA in 2012. The experts provided recommendations on the intra-operative anaesthetic management of patients for elective and emergency caesarean sections, as well as the post-operative monitoring and analgesic management of these patients. The recommendations were based on the experts’ understanding of the uniquely local healthcare environment in SA. Following the establishment of the SA reference standard, a national survey of anaesthetic service providers was conducted in 2014 to establish what the practises are in South Africa for caesarean section anaesthetics. Ninehundred- and-thirty-three survey responses were analysed, which equated to a 58% response rate. The majority of anaesthesia providers (97.8%) perform single shot spinal anaesthesia for caesarean sections. Thirty percent of respondents chose to use Quincke spinal needles, despite the increased risk of this needle causing post-dural puncture headaches (PDPH). The preferred local anaesthetic drug was 0.5% bupivacaine with dextrose, and fentanyl was the most commonly used additive agent, as opposed to common international practice, which advocates morphine. The survey also revealed that 58% of doctors work in hospitals that do not have a post-operative monitoring protocol for patients following caesarean section surgery. This contrasts to recommendations suggested by the national experts regarding patient monitoring requirements. A clinical trial was then conducted to compare the analgesic efficacy of two different doses of intrathecal morphine (50μg and 100μg) with 25μg fentanyl. Patients in both morphine treatment groups had significantly lower postoperative opioid requirements than patients in the fentanyl group. The pain numerical rating scale (NRS) scores were however not statistically different and there was also no difference in the side effects profile or emotional parameters measured, between the groups. This study highlights the differences in the recommended practise of obstetric anaesthesia in SA compared to other countries and demonstrates how obstetric anaesthesia is practised in SA. The final component of this study has demonstrated how international best practices can be easily implemented in SA to improve the anaesthetic care of the obstetric patient.MT201

Challenges and Research Directions in Medical Cyber-Physical Systems

Medical cyber-physical systems (MCPS) are lifecritical, context-aware, networked systems of medical devices. These systems are increasingly used in hospitals to provide highquality continuous care for patients. The need to design complex MCPS that are both safe and effective has presented numerous challenges, including achieving high assurance in system software, intoperability, context-aware intelligence, autonomy, security and privacy, and device certifiability. In this paper, we discuss these challenges in developing MCPS, some of our work in addressing them, and several open research issue

Impact of Interruption Frequency on Nurses\u27 Performance, Satisfaction, and Cognition During Patient-Controlled Analgesia Use in the Simulated Setting

Problem: Interruption during medication administration is a significant patient safety concern within health care, especially during the administration of high risk medications in nursing. Patient-controlled analgesia (PCA) devices are frequently associated with adverse events and have a four-fold increased risk of patient injury compared to non-PCA related adverse events. While the nature and frequency of interruptions have been established for nurses* medication processes, the impact of interruption frequency on nurses* PCA interaction has not been fully measured or described. Purpose: The purposes of this study were to quantify the impact of interruption frequency on registered nurses* (RN) performance, satisfaction, and cognitive workload during PCA interaction, and to determine nurses* perceptions of the impact of interruption frequency. Methods: This study employed a mixed-method design. First, an experimental repeated measures design was used to quantify the impact of interruption frequency on a purposive sample of nine medical-surgical RNs. The RNs completed PCA programming tasks in a simulated laboratory nursing environment for each of four conditions where interruption frequency was pre-determined. Four established human factors usability measures were completed for each of the four test conditions. The research questions were answered using repeated measures analysis of variance with (RM-ANOVA), McNamar*s test, and Friedman*s test. After each experiment, semi-structured interviews were used to collect data that were analyzed using inductive qualitative content analysis to determine RNs* perceptions of the impact of interruption frequency. Results: Results of the RM-ANOVA were significant for the main effect of interruption frequency on efficiency F(3,24)=9.592, p = .000. McNemar*s test did not show significance for the impact of interruption frequency on effectiveness (accuracy). Friedman test showed participant satisfaction was significantly impacted by interruption frequency (x2=9.47, df=3, p=0.024). Friedman test showed no significance for the main effect of interruption frequency on cognitive workload scores by condition type (x2=1.88, df=3, p=0.599). Results of the qualitative content analysis revealed two main categories to describe nurses* perception of interruption frequency: the nature of interruptions and nurses* reaction to the interrupted work environment. Discussion/Implications: The results suggested that interruption frequency significantly affected task completion time and satisfaction for participants but not participant accuracy or cognitive workload. A high error rate during PCA programming tasks indicated the need to evaluate the conditions in which RNs complete PCA programming as each error presents potential risk of patient harm. RNs* described the impact of interruption frequency as having a negative impact on the work environment and subsequently implement compensating strategies to counterbalance interruptions. RNs* perceived that patient safety was negatively impacted by frequent interruption. RNs experienced negative intrapersonal consequences as a results of frequent interruption. Additional study is needed to better understand the impact of interruption frequency on RNs* performance accuracy and cognitive workload