Internal reporting systems

Implement an internal reporting system focused on reporting to appropriate personnel and... 

The adage, what gets measured gets improved applies to transportation risk management. Compaiues should establish internal reporting systems for all transportation-related accidents/incidents. 

Designate a patient safety officer and create an internal reporting system. 

The voluntary system should be complementary to existing reporting systems. The goal is to integrate aggregate information from external systems to enhance the information contained in the internal reporting system. External reporting sys-... 

Internal Verification Systems or procedures are in place for reviewing performance against standards and milestones and reporting departures from established (external or internal) standards. Exceptions and deficiencies are corrected in a timely manner. 

These reports were in addition to the internal reporting for OSHA PSM and various local or state requirements. While Quality Chemical had long ago consolidated a number of these programs, there were still four different accident/incident reporting systems—one for external reporting of releases, one for external reporting of injuries and other nonrelease events, one for a corporate-wide database and one for each site itself. 

The Failure and Inventory Reporting System (FIRS) program was developed by the Geological Survey Division of the U.S. Department of the Interior for safety and pollution prevention devices on offshore structures that produce or process hydrocarbons. The program collected data on mechanical and some electromechanical systems on offshore oil platforms. About 8,000 failure events were documented. Access has been limited to internal materials management system use. No real-time access or periodic output products have been available. 

FIGURE 20.2 The involvement of RARE on apo-lO -lycopenoic acid-transactivated RARp expression. Upper panel Diagram of the RARp reporter vector with wild type and mutated R AREs. Lower panel HeLa cells transfected with the RARp reporter vector and an internal control vector were treated with 5 pmol/I. of apo-lO -lycopenoic acid or 1 pmol/L of all-trans retinoic acid for 24h. Luciferase activities were measured by dual-luciferase reporter system. Values are means of SEM of three replicate assays., statistically significantly different, as compared with control in the same group, P < 0.05. (Adapted from Lian, F. et al., Carcinogenesis, 28, 1567, 2007. With permission.)... 

An illustration of this has been the response of industry to the 8(e) notice requirements of the law. Most companies have established an internal communications system to collect potential 8(e) information, selected personnel to evaluate the information gathered, and have developed an expertise in handling this type of hazard reporting. Typically, the 8(e) notifier takes appropriate action or response on his own initiative to control or alleviate the risks involved. It has been commonplace for the notifier to advise his customers as well as his employees for the chemical involved of the information contained in the notice. 

Since then there have been many publications and reviews of the UK yellow card system and spontaneous reporting systems internationally.A summary of the capabilities and limitations of the method is given in Table 15.6. Although these have been discussed in the greatest detail over the past three decades, the obligations that exist for pharmaceutical companies in the reporting of adverse events to the regulatory authorities at both national and international levels make it essential to review them in this chapter. 

Russell, Jim H. 1990. (Internal report) Chemical storage and injection systems. Sugar Land, Tex. Nalco Chemical Company. 

Wysowski DK, Barash D. Adverse behavioral reactions attributed to triazolam in the Food and Drug Administration s Spontaneous Reporting System. Arch Intern Med 1991 151 2003-2008. 

Pyburn, R. 2004. SASA Pinal Report on Internal Control Systems and Management Systems. 

Every laboratory should have an internal accident-reporting system. This includes provisions for investigating the cause of an injury as well as any potentially serious incident that does not result in injury. The primary aim of such investigations should be to make recommendations to improve safety, not to assign blame for an incident. Local legal regulations may require reporting procedures for accidents or injuries. 

Wysowski, D., Barash, D. (1992, July). Use of spontaneous reporting system data. Archives of Internal Medicine, 152, 1528-1529. 

The CDC also participates in several collaborative international surveillance systems. An example is the Global Emerging Infections Sentinel Network (GeoSentinel). In the GeoSentinel system, the CDC has partnered with the International Society of Tfavel Medicine to set up a provider-based reporting network at travel and tropical medicine clinics in the U.S. and overseas (CDC, 2002). 

Administration spontaneous reporting system. Arch Intern Med 1992 152(3) 617-21. 

Keisu M, Wiholm BE, Palmblad J. Trimethoprim-sulpha-methoxazole-associated blood dyscrasias. Ten years experience of the Swedish spontaneous reporting system. J Intern Med 1990 228(4) 353-60. 

Events Reporting System (AERS) of the FDA which also continuously assesses the safety of marketed drugs. This is often supplemented by internal safety databases that are maintained by pharmaceutical companies separately from governmental databases. 

Information received through the MedWatch program is entered into the Adverse Event Reporting System (AERS) database. The AERS database is designed to permit electronic or paper submission of reports, comply with international standards and terminology, and facilitate pharmacovigilance screening. In addition to the... 

Since then there have been many publications and reviews of the UK yellow card system and spontaneous reporting systems internationally. ... 

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