Reporting systems mandatory

A nationwide mandatory reporting system should be established. 

To Err Is Human spawned legislation at the state level that requires the development of voluntary and mandatory reporting systems, with legal protections (Prager, 2000). To date, twenty states have legislated the implementation of mandatory reporting systems the National Academy of State Health Policy writes informative reports on patient safety initiatives that are under way at the state level. 

The nature of organisation of the reporting system is it local (e.g, plant-based) or central (e.g. company-based) Is reporting voluntary or mandatory ... 

Several types of data are routinely collected related to infectious disease surveillance, including morbidity, mortality, and health indicator data (CDC, 1992). Each state has requirements for mandatory reporting by health care providers and facilities, including laboratories, of cases of notifiable infectious diseases. There is a national notifiable disease list as well, for which reporting is voluntary, with data compiled through the National Notifiable Disease Surveillance System (CDC, 2004d, 2006). 

ADR and Infections Reporting System are following ICH rules for reporting within 15 and 30 days. From October 2003, it became mandatory to use MedRA for individual adverse event report. 

Untoward vaccine effects are variable, manifesting from injection site irritation, fever, and irritability to encephalopathy, paralysis, and even death. - " " Reporting of certain vaccine adverse events to the Vaccine Adverse Event Reporting System (VAERS) is mandatory. VAERS was established by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) to facilitate the process of gathering postmarketing surveillance data on vaccine-related adverse events. VAERS reports record adverse events temporally but not necessarily eausally associated with vaccination. 

To correct any deficiencies found as a result of the Occurrence Reporting system, a Design Organisation might elect to issue a Service Bulletin (SB) to end users. From a legal perspective, the SBs are not mandatory in character (unless under AD cover letter). ... 

In 1999, the Institute of Medicine released a report estimating that between 44,000 and 98,000 deaths occur in American hospitals each year due to medical errors. Errors which do not result in death may result in irijury or a prolonged stay with increased costs to the individual, to the hospital and the cormnunity. Most worryingly, many of these events are preventable. The main suggestion from the Institute of Medicine s report was to learn from errors and improve the system rather than blame individuals for errors implement mandatory or volimtary error reporting systems and develop strong safety leadership. These activities are also the focus of this chapter. 

In the aftermath of public and political reaction to the Institute of Medicine (lOM) report To Err Is Human (Kohn, Corrigan, and Donaldson, 1999), and despite the initial fixation on mandatory reporting, two of the report s key lessons seemed to have caught hold It s a systems problem and We need to create a culture of safety. Although both phrases were widely mouthed by politicians and health care leaders alike, it was quickly apparent that few who spoke them had much understanding of the profound implications of either mantra. 

Evidently, if they are working in a productive environment and initiative is expected, the project performers must have some leeway. That is not to say that all procedures should be optional this has been tried often enough - it is risky on small projects and disastrous on large ones. The ideal is possibly to have two sets of procedures, the first of which is mandatory to the project team, and the second of which will be developed by team members who are as close to the level of performance as possible, subject to whatever approval seems sensible. It is important of course to ensure that individual accountability and measurability of performance are retained. The first set of procedures may include matters such as documentation control, financial accounting practice, progress and cost reporting systems, and requirements for engaging in contracts namely those practices that make project work auditable and comprehensible to others. The second set may simply be a list of other procedures which are usually found to be necessary, backed up by examples found to be acceptable in the past. 

Dr. Dunn mentioned during his presentation that one of the outcomes of a monitoring system is a mandatory report. He mentioned implicitly that a mandatory report would be followed by mandatory action. We know of course that this is not always the case many reports, considered to be mandatory, are never followed by any precise action Therefore, I consider that a central part in the monitoring program should be the commitment by some agency that it will take action and in fact, until that commitment is reached, it is probably rather futile to set up a monitoring system. In UNICEF, we like to talk about the "triple A cycle" assessment, analysis, action. 

For a mixture of enantiomers it is thus possible to determine the ee-value without recourse to complicated calibration. The fact that the method is theoretically valid only if the g factor is independent of concentration and if it is linear with respect to ee has been emphasized repeatedly.84-89 However, it needs to be pointed out that these conditions may not hold if the chiral compounds form dimers or aggregates, because such enantiomeric or diastereomeric species would give rise to their own particular CD effects.88 Although such cases have yet to be reported, it is mandatory that this possibility be checked in each new system under study. 

Many of the more established techniques have been validated through collaborative studies which becomes of greater importance as laboratories seek to become accredited via ISO, EN or related systems where the use of official or well validated methods is mandatory. New instrumental techniques are constantly being reported in the literature but it often requires many years before procedures are introduced, validated and then applied within the food industry. Recent techniques that can be included in this category are capillary electrophoresis and liquid chromatography-mass spectrometry (LC-MS). In time procedures based on these techniques will also become accepted as routine methods and are likely to be adopted by some of the official international bodies like the AOAC International, CEN, ISO, etc. 

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