Performing Patient Safety Analysis

Many methods and approaches that have been developed in the fields of reliability, safety, quality, and human factors are being used in various other areas. This chapter presents a number of such methods and approaches used to perform patient safety analysis. 

Write an essay on methods for performing patient safety analysis. 

This chapter presents various important aspects of patient safety organizations, data sources, and mathematical models useful for performing patient safety analysis. 

Chapter 3 presents introductory aspects of safety and human factors. Chapter 4 is devoted to methods considered useful to perform patient safety analysis. These methods include failure modes and effect analysis (FMEA), fault tree analysis (FTA), root cause analysis (RCA), hazard and operability analysis (HAZOP), six sigma methodology, preliminary hazard analysis (PFfA), interface safety analysis (ISA), and job safety analysis (JSA). Patient safety basics are presented in Chapter 5. This chapter covers such topics as patient safety goals, causes of patient injuries, patient safety culture, factors contributing to pahent safety culture, safe practices for better health care, and patient safety indicators and their selection. 

A set of given patient safety or other data is only useful if it is analyzed properly. Certain characteristics of data play a key role in describing the nature of a given set of data, thus allowing people to make better decisions. This section presents a number of statistical measures considered useful to perform patient safety-related analysis. 

A large number of probability distributions have been developed in the area of mathematics to perform various types of analysis [15,161. This section presents some of the probability distributions considered useful to perform patient safety-related analysis. 

Table 2.1 presents Laplace transforms of a number of functions considered useful to perform mathematical patient safety analysis [18,19]. 

Professionals working in the area of human factors have developed many mathematical formulas for estimating various types of human factors-related information. Some formulas that are useful for performing patient safety-related analysis are presented below. 

This is a widely used method to perform various types of reliability and safety analysis of engineering systems in the industrial sector. The method is named after Andrei A. Markov (1856-1922), a Russian mathematician. The method can also be used to perform patient safety-related analysis. 

Chapter 10 is devoted to medical device usability. It covers topics such as medical device users and use environments, medical device user interfaces, an approach to develop medical devices effective user interfaces, guidelines to reduce medical device user interface-related errors, guidelines for designing hand-operated devices with respect to cumulative trauma disorder, and useful documents for improving usability of medical devices. Chapter 11 presents three important topics relating to patient safety patient safety organizations, data sources, and mathematical models for performing probabilistic patient safety analysis. 

The code will be broken and data will be analyzed when the 12-mo follow-up has been completed for all patients. At that time, DHA therapy will be offered to all patients who desire to receive it. Clinical and laboratory studies will be monitored by an independent data and safety monitoring committee. This committee will also perform an interim analysis when 30 patients have completed assessment and has permission to terminate the study if there are significant favorable findings or unanticipated adverse outcomes. A determination of statistical power indicates that this sample size is sufficient to detect a major effect (0.862 standard deviations). With a more modest effect of 25%, however, the statistical power diminishes to 60%. The study has been approved by the Institutional Review Board at the Johns Hopkins Medical Institutions and is supported by a research grant from the Office of Orphan Products Development at the Food and Drug Administration. Fifty-two patients are enrolled in the study at this time. The code has not yet been broken. No adverse effects attributable to the medication have been observed. 

In order to allow for efficient safety monitoring of the study, an independent data monitoring committee composed of international experts in movement disorder and stereotactic neurosurgery will analyze safety data at predefined intervals during the study. The first safety analysis will be performed when 1-month data from 12 patients is complete, the second will be with 1-month data from 36 patients, and the third and last when all patients have reached the 1-month time point after surgery. 

This chapter presents various mathematical concepts considered useful to perform mathematical analysis in the area of patient safety. 

This agency was created in July 2001 in the United Kingdom to improve patient safety within the framework of the UK National Health Service (NHS) by encouraging voluntary reporting of medical-related errors, performing analysis, and initiating appropriate preventive measures. Since 2005, the NPSA has also been responsible for the following items [7] ... 

Various types of mathematical models have been developed to perform human performance reliability analysis in the area of engineering. Some of these models can also be used in the area of patient safety to conduct human performance reliability analysis. Four of these models are presented below. 

Providers and leaders in health care are adept at making changes in complicated domains of work, snch as when they implement qnality improvement projects or perform open-heart surgery Unfortunately, the mnltiple steps of analysis and the multiple perspectives necessary to design and control complicated systems pose limitations for those who work in the area of patient safety Patient safety is beyond complicated. It is complex. 

HL (Hazard Log). The information in the change form is unable to provide a compelling argument that the ehange is acceptably safe. In such cases, a separate safety analysis is performed and recorded in the safety files/hazard log. A major release of an eleetronie patient records system would fall into this category. 

A retrospective analysis of 380 patients with Wilson disease in Germany and Austria and 25 additional patients from the EUROWILSON registry was performed [70 ]. Due to changes in medication, an analysis of D-penicillamine (n=326) and trientine (n= 141) was performed. Adverse effects leading to discontinuation of treatment were more common in D-penicillamine (n = 94, 28.8%) than in trientine group (n = 10, 7.1%). Safety analysis was only performed on adverse events that led to halt of treatment. Adverse effects included sicca symptoms (n=7), fatigue... 

In defining the criticality of an identified failure mode there was a debate as to whether this should be determined by considerations of patient management or more narrowly in terms of the performance of the laboratory. As the laboratory cannot always judge the importance to the doctor of an individual test result, it was decided to draw the boundary of the safety analysis around the department itself. This meant that the FMECA focused on safe handling of samples and data (both physical and electronic) within the laboratory system. 

Cost-minimisation analysis are performed when the clinical outcomes (e.g. efficacy and safety) of the comparator groups are virtually identical and for all practical purposes can be considered to be equal. Because no decision can be made based on differences in the clinical endpoints, decisions are based on the incremental costs of the treatment pathways. Such was the case in a study that assessed the cost-effectiveness of treating proximal deep vein thromboses (DVT) at home with low molecular weight heparin versus standard heparin in hospital therapy. A cost-minimisation approach was chosen for this analysis because the results from a comparative clinical trial confirmed that there were no statistically significant differences in safety or efficacy between the two treatment groups. The study authors concluded that for patients with acute proximal DVTs, treatment at home with low molecular weight heparin was less costly than hospital treatment with standard heparin. ... 

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