Patient safety addressing

A final challenge for early screening is the detection of genotoxic impurities and synthetic intermediates which can create occupational/manufacturing as well as patient safety issues. This again is a complex issue because the material screened from a library might be synthesized and purified by different routes to a drug that enters the clinic. These issues are addressed in a later section. 

Lead CRA—The lead contract research associate is usually responsible for interfacing with field monitors and addressing investigator non-compliance. They review field reports provided by field staff- and determine adequate follow-up to problems that have been identified by the field staff"as well as investigators. Clinical QA must ensure that the lead CRA is adequately trained to respond comprehensively and in a timely manner. It must also be formally trained on the notification process required when patient safety or data integrity is in question. 

The importance of a comprehensive specimen identification system throughout the clinical laboratory cannot be understated. Both the College of American Pathologists (CAP) (1) and The Joint Commission (JCAHO) (2) have addressed this important subject with directives that address the pre-analytical, analytical and post-analytical phases of specimen processing. These patient safety initiatives date back to the 1990 s and the formation of the National Patient Safety Foundation (3). These mandates have become the backbone of most laboratories Quality and Safety Programs and offer an excellent foundation for procedures that assure the safe and accurate identification of patient specimens throughout the analysis and reporting of critical laboratory tests. 

The JCAHO has a major focus on patient safety, including medication safety. As facilities report internal sentinel events to JCAHO, they are reviewed and analyzed. JCAHO has issued a number of sentinel event alerts, notifying healfh care organizafions and consumers to specific safety issues and practice recommendations to improve them. Several have addressed medication issues such as potassium chloride and other concentrated electrolytes, insulin, heparin, injectable opiates and narcotics, infusion pumps, and look- and sound-alike medications and abbreviations. Table 16.10 summarizes the recommendations for these sentinel event alerts. ... 

Part three involves creating safety-related performance standards. In terms of health professionals, the report asks licensing organizations to examine how they identify unsafe practitioners. In addition, professional organizations should address patient safety in national conferences, journals, and training programs (e.g., residencies). ... 

Since its establishment in 1989, AHRQ has sponsored and conducted research to improve the quality of health care, reduce its cost, and increase access. It also supports research to address patient safety issues and medication errors. AHRQ s goal is to provide information that allows people to make better decisions about healthcare. 

To enhance the quality, appropriateness, and effectiveness of health care services, and access to these services the federal government in the Omnibus Budget Reconciliation Act of 1989 (Public Law 101-239) established the AHCPR. The act, sometimes referred to as the Patient Outcome Research Act, called for the establishment of a broad-based, patient-centered outcomes research program. In addition to the traditional measures of survival, clinical endpoints and disease- and treatment-specific symptoms and problems, the law mandated measures of functional status and well-being and patient satisfaction. In 1999, then President Clinton signed the Healthcare Research and Quality Act, reauthorizing AHCPR as the AHRQ until the end of fiscal year 2005. Presently, its mission is to improve the outcomes and quality of health care, reduce its costs, address patient safety and medical errors, broaden access to effective services, and improve the quality of health care services. 

The process chemist must develop a commercial route for a drug candidate that addresses cost issues, environmental concerns, atom economy, and ease of synthesis, and with the specified quality attributes that will ensure patient safety during development and post-launch, underscoring the importance of process research and development disciplines in the industry. 

The Health Foundation. Safer Patients Initiative. Lessons from the first major improvement programme addressing patient safety in the UK. London The Health Foundation 2011. 

Until relatively recently litigation was seen as a financial and legal problem, patients who sued were often seen as difficult or embittered and doctors who helped them as professionally and often personally suspect. Only gradually did those addressing the problem come to understand that litigation was a reflection of the much more serious underlying problem of harm to patients for this reason litigation is part of the story of patient safety. 

Patient safety is concerned primarily with the avoidance, prevention and amelioration of adverse outcomes or injuries stemming from healthcare itself. It should address events that span the continuum of errors and deviations to accidents. 

Second, consider all the myriad forms of harm that can come from healthcare complications of surgery, infection from unsafe injections, infection from over crowded hospitals, adverse drug reactions, overdoses from badly designed infusion pumps and so on. Should we assume that all these are necessarily due to error If we equate patient safety with error reduction, we run the risk of not addressing any form of harm which is either not due to error, or only partly due to error. 

Evidence based medicine then provides the foundation of good practice but does not directly address the safety issue, which is why care known to be effective is not delivered to the patient. From our point of view, the most important point is that an evaluation of a clinical practice has led to questions of a psychological nature and towards core patient safety issues of error and human behaviour. These themes emerge more strongly in the next section, which addresses some criticisms of the report s approach to patient safety. 

First how to ensure that every patient who needs anticoagulation receives it and second how to ensure that the medication is delivered flawlessly - on time, in the right dose, every time, without fail. Such systems are at the heart of patient safety but not addressed by the report. 

Patient safety, you would think from the name, has the patient s interests at heart and so it does in many respects. However, this has seldom extended to actually involving the patient in the quest for safer care. Safety is addressed and discussed in multiple ways, and lessons are sought from all manner of other industries and experts, from the disciplines of psychology, ergonomic, engineering and many others. Yet the one source of experience and expertise that still remains largely ignored is that of the patient. 

A second reason is that for all the books, reports, articles and Websites devoted to patient safety, there is still no straightforward overview of the field. The books that are available are mostly multi-author edited texts which, while they bring a rich diversity of perspective, are not primarily aimed at explaining the basic principles, characteristics and direction of the field. My aim has been to show the landscape of patient safety how it evolved, the research that underpins the area, the key conceptual issues that have to be addressed, and the practical action needed to reduce error and harm and, when harm does occur, to help those involved. 

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