Significant Incident Reporting

The remaining contents of a formal written incident report can vary significantly depending on circumstances. A collection of data and additional reference information that some, but not all, readers may need is often included as an appendix. Typical supplemental information might include ... 

It has been demonstrated that At is embryotoxic in pregnant mice, and there also exists a dose-related occurrence of associated fetal malformations (29, 30). Long-term studies in female rats that had received 0.5 /tCi g At systemically indicated a significant incidence of radiation-induced mammary carcinomata (39/45 44%) and endometrial polyps (43/55 76.4%) at 14 months after treatment. No thyroid tumors were found (50). Detailed macroscopic radiation dosimetric studies related to the biodistribution of At in animal models have been reported (29, 33, 39). 

Triethanolamine in the diet of ICR mice at levels of 0.03% or 0.3% caused a significant increase in the occurrence of thymic and non-thymic tumors in lymphoid tissues of females. It has recently been suggested that this increase in lymphomas in female ICR mice may be attributable to an unusually low incidence of lymphomas reported in the control animals (i.e., the lymphoma incidence reported in the treated groups is similar to that usually found in controls). In a follow-up study, B6C3F1 mice administered 1% or 2% triethanolamine in drinking water for 82 weeks showed no dose-related increase in the incidence of any tumor. ... 

In residents of Seveso, Italy, a significant rise in the incidence of birth defects, as compared to pre-accident levels, was observed the year after the accident (Bisanti et al. 1980). A variety of birth defects were observed, but the incidence for any particular defect was not elevated. The authors suggest that the rise in birth defects may not be related to 2,3,7,8-TCDD exposure. Prior to 1976, birth defects in Italy were usually under reported the authors note that the reported incidences of birth defects after the accident (23 per 1,000 births) were similar to incidences reported in other western countries. Thus, the increased incidence may be reflective of the increased reporting rather than an increased number of birth defects. In a study which assessed the risk of birth defects for the 6-year period after the Seveso accident, no increases were observed for the risk of total defects (RR of 1.2, 90% Cl of 0.88-1.64 for zones A and B and RR of 0.97, 90% 0=0.83-1.13 for zones A, B, and R), major defects RR of 1.02, 90% 0=0.64-1.61 for zones A and B and RR of 0.83, 90% 0=0.67-1.04 for zones A, B and R), and minor defects RR of 1.44 90% 0=0.92-2.24 for zones A and B and RR of 1.14, 90% 0=0.92-1.42 for zones A, B and R) (Mastroiacovo et al. 1988). The small number of observed birth defects limits the statistical power of this study to detect significant increases in a specific defect. 

In extreme cases, individuals are fired for incompetence or negligence in their duties. These organizations tend to report a small number of incidents, and the incidents reported include significant observable events such as loss of life, major equipment damage, environmental release of contaminants, or significant loss of production. 

Each of the items covered as Good Intentions showed a flaw in judgment. None of the principleN were unique and no decision was so urgent that the change needed to be accomplished immediately. All technical plant employees could easily understand the problems after they occurred and most of the technical employees could have spt)tted the weaknesses prior to the incident, if they had been afforded the opportunity for a well-disciplined review (see Chapter 10). Happily there were no significant injuries reported in these accidents, which caused more than 1 million of losses. However, wo don t know about the ducks. And yet, some accidents resulting from similar moditications have caused injuries and even deaths. 

Headache is one of the most frequently reported adverse events in clinical trials where PPIs have been examined (frequency 1.3-8.8%). Patients with headache also had a significant incidence of diarrhea, nausea, and dizziness. A discontinuation of PPI therapy resulted in a cessation or reduction of the headache in 80.0% (20 of 25) (156). 

Thus, if the cancer death rate in the U.S. was about 500,000 per year out of a population of 250 million, then this translates to 2 deaths per year per 1000 population — the same number as the cancer incidence reported for the Hopi, which is very low as compared to the cancer incidences in the United States of 1 in 4, or 250 per 1000. The inference is that cancer incidence is greater or much greater than the death rate, or there may be a significant time lag between incidence and death, also... 

The rainbow trout is known to be one of the most sensitive animals to the toxic effects of dietary aflatoxin, especially the hepatocarcinogenic effects. The LD5Q of pure aflatoxin in trout is 0.5 mg/kg for a single dose, and 0.3 mg/kg for a dose given over a 5-day period. Trout fed levels as low as 0.4 yg/kg in the diet showed a significant incidence of hepatoma after 12 months exposure. In the latter case, the total intake of aflatoxin Bi over the one-year period would be 0.1-0.2 yg. In trout fed aflatoxin at 20 yg/kg for 20 days, incidence of hepatoma was 40% after 12 months. Recently, it was reported that when embryo-nated trout eggs were placed in an aqueous solution of aflatoxin Bl (0.5 yg/ml) for only 1 hour, the incidence of hepatoma was 40% after 10 months (20). Table II shows that the Fischer strain of rat is also very susceptible to the hepatocarcinogenic effects of aflatoxin B (18). 

If evidence of testicular atrophy was observed, we would be interested in designing a clinical study which would assess reproductive function in the exposed workers. If a two year ingestion study in rats reported a statistically significant incidence of neurotoxicity, we would want to investigate whether neurotoxic effects also were produced in an exposed worker population. 

System history/expeiience (e.g. accident/incident reports and significant regulatory changes such as SFAR88 which altered fuel tank ignition prevention guidance). 

Once admitted to PICU, these children are of course much more likely to receive the treatment they need, but they then face other hazards recently mapped in a number of studies. In The Netherlands, Snijders and colleagues reviewed 4846 incident reports from 3859 admissions to neonatal intensive care units, the first speciality based study of locally reported incidents in these units. Medication and equipment problems dominated the reports though diagnostic issues, which are not usually well reported, were also frequent (Table 4.4). Significant patient harm was described in 70 of these reports ( 2% of admissions) ... 

This section lists and describes briefly the identified main developments relevant for helicopter safety in the study period 1999-2008. The list results from a comprehensive review of relevant literature and studies, accident/incident reports and statistics, as well as interviews with key participants in the industry (pilots, engineers, managers and ATC-personnel). Some preliminary evaluations have been done of the identified changes. The developments considered to have the most impact on the RIFs are described in section 2.1 and 2.2. The developments considered to be less significant with respect to safety are found in section 2.3. Each of the developments may impact one or more of the RIFs (for frequency and/or consequence) see Chapter 3. 

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