Directive 2010/45/EU OF THE EU Parliament on standards of quality and safety of human organs intended for transplantation

Over the past 50 years organ transplantation has become an established worldwide practice, bringing immense benefits to hundreds of thousands of patients. The use of human organs (hereinafter â?~organsâ?T) for transplantation has steadily increased during the last two decades. Organ transplantation is now the most cost-effective treatment for end-stage renal failure, while for end-stage failure of organs such as the liver, lung and heart it is the only available treatment. Click here to download PDF 806kb You can read a summary of the document here

Capturing diagnosis-timing in ICD-coded hospital data: recommendations from the WHO ICD-11 topic advisory group on quality and safety.

PURPOSE: To develop a consensus opinion regarding capturing diagnosis-timing in coded hospital data. METHODS: As part of the World Health Organization International Classification of Diseases-11th Revision initiative, the Quality and Safety Topic Advisory Group is charged with enhancing the capture of quality and patient safety information in morbidity data sets. One such feature is a diagnosis-timing flag. The Group has undertaken a narrative literature review, scanned national experiences focusing on countries currently using timing flags, and held a series of meetings to derive formal recommendations regarding diagnosis-timing reporting. RESULTS: The completeness of diagnosis-timing reporting continues to improve with experience and use; studies indicate that it enhances risk-adjustment and may have a substantial impact on hospital performance estimates, especially for conditions/procedures that involve acutely ill patients. However, studies suggest that its reliability varies, is better for surgical than medical patients (kappa in hip fracture patients of 0.7-1.0 versus kappa in pneumonia of 0.2-0.6) and is dependent on coder training and setting. It may allow simpler and more precise specification of quality indicators. CONCLUSIONS: As the evidence indicates that a diagnosis-timing flag improves the ability of routinely collected, coded hospital data to support outcomes research and the development of quality and safety indicators, the Group recommends that a classification of 'arising after admission' (yes/no), with permitted designations of 'unknown or clinically undetermined', will facilitate coding while providing flexibility when there is uncertainty. Clear coding standards and guidelines with ongoing coder education will be necessary to ensure reliability of the diagnosis-timing flag.

Certification and integration of environment with quality and safety – a path to sustained success

According to Wright [1] certification of products and processes began during the 1960’s in the manufacturing industry, as a tool to control and assure the quality/conformity of products and services provided by suppliers to customers/consumers. Thus, the series of ISO 9000 was published first time, in 1987 and it was been created with a flexible character, to be reviewed periodically. Later, were published others normative references, which highlight the ISO 14001 in 1996 and OHSAS 18001 in 1999. This was also, the natural sequence of the certification processes in the organizations, i.e., began with the certification of quality management systems (QMS) followed by the environmental management systems (EMS) and after for the Occupational Health and Safety Management System (OHSMS). Hence, a high percentage of organizations with an EMS, in accordance with the ISO 14001, had also implemented, a certified QMS, in accordance with ISO 9001. At first the implementation of a QMS was particularly relevant in high demanding activity sectors, like the automotive and aeronautical industries, but it has rapidly extended to every activity sector, becoming a common requisite of any company worldwide and a factor of competitiveness and survival. Due to the increasingly demanding environmental legislation in developed countries, companies nowadays are required to seriously take into consideration not only environmental aspects associated to the production chain itself, but also to the life cycle of their products.

Development and Characterization of bioactive, edible whey protein films and coatings to improve quality and safety of Food products

Dissertação para a obtenção de grau de doutor em Ciências da Engenharia e Tecnologia

How many diagnosis fields are needed to capture safety events in administrative data? Findings and recommendations from the WHO ICD-11 Topic Advisory Group on Quality and Safety

OBJECTIVE: As part of the WHO ICD-11 development initiative, the Topic Advisory Group on Quality and Safety explores meta-features of morbidity data sets, such as the optimal number of secondary diagnosis fields. DESIGN: The Health Care Quality Indicators Project of the Organization for Economic Co-Operation and Development collected Patient Safety Indicator (PSI) information from administrative hospital data of 19-20 countries in 2009 and 2011. We investigated whether three countries that expanded their data systems to include more secondary diagnosis fields showed increased PSI rates compared with six countries that did not. Furthermore, administrative hospital data from six of these countries and two American states, California (2011) and Florida (2010), were analysed for distributions of coded patient safety events across diagnosis fields. RESULTS: Among the participating countries, increasing the number of diagnosis fields was not associated with any overall increase in PSI rates. However, high proportions of PSI-related diagnoses appeared beyond the sixth secondary diagnosis field. The distribution of three PSI-related ICD codes was similar in California and Florida: 89-90% of central venous catheter infections and 97-99% of retained foreign bodies and accidental punctures or lacerations were captured within 15 secondary diagnosis fields. CONCLUSIONS: Six to nine secondary diagnosis fields are inadequate for comparing complication rates using hospital administrative data; at least 15 (and perhaps more with ICD-11) are recommended to fully characterize clinical outcomes. Increasing the number of fields should improve the international and intra-national comparability of data for epidemiologic and health services research, utilization analyses and quality of care assessment.

Effect of computerisation on the quality and safety of chemotherapy prescription.

BACKGROUND: Chemotherapy is prescribed according to protocols of several cycles. These protocols include not only therapeutic agents but also adjuvant solvents and inherent supportive care measures. Multiple errors can occur during the prescription, the transmission of documents and the drug delivery processes, and lead to potentially serious consequences. OBJECTIVE: To assess the effect of a computerised physician order entry (CPOE) system on the number of errors in prescription recorded by the centralised chemotherapy unit of a pharmacy service in a university hospital. PATIENTS AND METHODS: Existing chemotherapy protocols were standardised by a multidisciplinary team (composed of a doctor, a pharmacist and a nurse) and a CPOE system was developed from a File Maker Pro database. Chemotherapy protocols were progressively introduced into the CPOE system. The effect of the system on prescribing errors was measured over 15 months before and 21 months after starting computerised protocol prescription. Errors were classified as major (dosage and drug name) and minor (volume or type of infusion solution). RESULTS: Before computerisation, 141 errors were recorded for 940 prescribed chemotherapy regimens (15%). After introduction of the CPOE system, 75 errors were recorded for 1505 prescribed chemotherapy regimens (5%). Of these errors, 69 (92%) were recorded in prescriptions that did not use a computerised protocol. A dramatic decrease in the number of errors was noticeable when 50% of the chemotherapy protocols were prescribed through the CPOE system. CONCLUSION: Errors in chemotherapy prescription nearly disappeared after implementation of CPOE. The safety of chemotherapy prescription was markedly improved.

ICD-11 for quality and safety: overview of the who quality and safety topic advisory group.

This paper outlines the approach that the WHO's Family of International Classifications (WHO-FIC) network is undertaking to create ICD-11. We also outline the more focused work of the Quality and Safety Topic Advisory Group, whose activities include the following: (i) cataloguing existing ICD-9 and ICD-10 quality and safety indicators; (ii) reviewing ICD morbidity coding rules for main condition, diagnosis timing, numbers of diagnosis fields and diagnosis clustering; (iii) substantial restructuring of the health-care related injury concepts coded in the ICD-10 chapters 19/20, (iv) mapping of ICD-11 quality and safety concepts to the information model of the WHO's International Classification for Patient Safety and the AHRQ Common Formats; (v) the review of vertical chapter content in all chapters of the ICD-11 beta version and (vi) downstream field testing of ICD-11 prior to its official 2015 release. The transition from ICD-10 to ICD-11 promises to produce an enhanced classification that will have better potential to capture important concepts relevant to measuring health system safety and quality-an important use case for the classification.

Quality and safety requirements for sustainable phage therapy products.

The worldwide antibiotic crisis has led to a renewed interest in phage therapy. Since time immemorial phages control bacterial populations on Earth. Potent lytic phages against bacterial pathogens can be isolated from the environment or selected from a collection in a matter of days. In addition, phages have the capacity to rapidly overcome bacterial resistances, which will inevitably emerge. To maximally exploit these advantage phages have over conventional drugs such as antibiotics, it is important that sustainable phage products are not submitted to the conventional long medicinal product development and licensing pathway. There is a need for an adapted framework, including realistic production and quality and safety requirements, that allowsa timely supplying of phage therapy products for 'personalized therapy' or for public health or medical emergencies. This paper enumerates all phage therapy product related quality and safety risks known to the authors, as well as the tests that can be performed to minimize these risks, only to the extent needed to protect the patients and to allow and advance responsible phage therapy and research.

The effect of sodium reduction and the use of herbs and spices on the quality and safety of bologna sausage

In this study, the replacement of 50% NaCl by KCl in Bologna sausage with the addition of herbs and spice blends (coriander, onion, white pepper, cardamom, and Jamaican pepper) was evaluated. The formulations tested showed a significant reduction in the sodium content with no major alterations in the emulsion stability, texture, and microbiological characteristics. The use of 50% KCl caused a reduction in the sensory quality leading to a significant decrease in the consumers' purchase intention. The formulations with the addition of herbs and spice blends presented better results in the sensory evaluation indicating that this strategy can reduce the negative effects resulting from the use of KCl.

Race-to-the-bottom or -top at home or abroad: Health and safety standards and the multinational firm

We develop a model to illustrate potential complexities in the relationship between corporate geographical diversification and the health and safety (H&S) standards set in national jurisdictions. A firm, that initially has a plant in its home country, may choose to also have one or two foreign plants in order to improve its bargaining position versus local governments, and so ensure reduced H&S standards, i.e. a race-to-the-bottom. However, contrary to the main focus of the popular debate on this topic, we note the potential for the race-to-the-bottom tendency to be exerted on H&S standards in the multinational company’s home rather than host country, and also for an upward push on H&S to instead result.

Quality and safety of pet treats: assessment of the microbial safety and quality of pet treats

The aim of this study was to evaluate the hygienic and sanitary conditions of pettreats from an export industry. The occurrence of Salmonella, enumerated sulfite-reducing Clostridium (SRC), coagulase-positive Staphylococcus (CPS) and total(TC) and thermotolerant coliforms (TTC) was studied. Of the 108 samples ana-lyzed, 22 were contaminated by some microorganism. TC were detected at twosamples (3.5 × 101and 4.5 × 101colony-forming units [cfu]/g), SRC in 19 samples(1.0 × 101to 1.3 × 105cfu/g) and Salmonella spp. at only one sample; CPS andTTC were not detected. These findings indicate the microbiological safety of mostitems, except for a mix of dried bovine offal, with 1.3 × 105cfu/g of SRC, and onemix of dehydrated bovine viscera contaminated with Salmonella. The current pro-duction processes and the food safety management system are adequate to guar-antee the production of microbiologically safe foods, but that some improvementscan still be made with regard to cleaning and disinfection and hygiene training.

Microbiological quality and safety of minimally processed vegetables marketed in Campinas, SP-Brazil, as assessed by traditional and alternative methods

In this study, a total of 172 samples of minimally processed vegetables (MPV) were collected from supermarkets in the city of Campinas, Brazil. The MPV were analyzed using traditional and/or alternative methods for total aerobic mesophilic bacteria, total coliforms, Escherichia coil, coagulase positive staphylococci, Salmonella and Listeria monocytogenes. All the MPV analyzed presented populations of aerobic mesophilic microorganisms and total coliforms were >4 log(10) CFU/g and 1.0-3.4 log(10) CFU/g, respectively. E. coil was enumerated in only 10 samples out of 172 collected, while none of the 172 samples of MPV presented contamination by coagulase positive Staphylococcus (<10(1) CFU/g). Among the four methods used for detection of Salmonella in MPV (Vidas, 1,2 Test, Reveal, and Traditional), when Reveal was used a total of 29 positive samples were reported. For L monocytogenes, the four methods tested (Vidas, Vip, Reveal, and traditional) performed similarly. The presence of Salmonella and L monocytogenes in MPV was confirmed in one (watercress) and two samples (watercress and escarole), respectively. In conclusion, it has been observed that the microbiological quality of MPV commercialized in Campinas is generally satisfactory. Besides, the choice of microbiological method should be based not only on resource and time issues, but also on parameters such as sensitivity and specificity for the specific foods under ahalysis. (C) 2012 Elsevier Ltd. All rights reserved.

Quality and safety of oils and fats obtained as co-products or by-products of the food chain and destined to animal production

The aim of the first part of this thesis was to evaluate the effect of trans fatty acid- (TFA), contaminant, polycyclic aromatic hydrocarbon (PAH)- and oxidation productenriched diets on the content of TFA and conjugated linoleic acid (CLA) isomers in meat and liver of both poultry and rabbit. The enriched feedings were prepared with preselected fatty co-and by-products that contained low and high levels of TFA (low, palm fatty acid distillate; high, hydrogenated palm fatty acid distillate), environmental contaminants (dioxins and PCBs) (two different fish oils), PAH (olive oil acid oils and pomace olive oil from chemical refining, for low and high levels) and oxidation products (sunflower-olive oil blend before and after frying), so as to obtain single feedings with three enrichment degrees (high, medium and low) of the compound of interest. This experimental set-up is a part of a large, collaborative European project (http://www.ub.edu/feedfat/), where other chemical and health parameters are assessed. Lipids were extracted, methylated with diazomethane, then transmethylated with 2N KOH/methanol and analyzed by GC and silver-ion TLC-GC. TFA and CLA were determined in the fats, the feedings, meat and liver of both poultry and rabbit. In general, the level of TFA and CLA in meat and liver mainly varied according to those originally found in the feeding fats. It must be pointed out, though, that TFA and CLA accumulation was different for the two animal species, as well as for the two types of tissues. The TFA composition of meat and liver changes according to the composition of the oils added to the feeds with some differences between species. Chicken meat with skin shows higher TFA content (2.6–5.4 fold) than rabbit meat, except for the “PAH” trial. Chicken liver shows higher TFA content (1.2–2.1 fold) than rabbit liver, except for the “TRANS” and “PAH” trials. In both chicken and rabbit meats, the TFA content was higher for the “TRANS” trial, followed by the “DIOXIN” trial. Slight differences were found on the “OXIDATION” and “PAH” trends in both types of meats. In both chicken and rabbit livers, the TFA content was higher for the “TRANS” trial, followed by those of the “PAH”, “DIOXIN” and “OXIDATION” trials. This trend, however, was not identical to that of feeds, where the TFA content varied as follows: “TRANS” > “DIOXIN” >“PAH” > “OXIDATION”. In chicken and rabbit meat samples, C18:1 TFA were the most abundant, followed by C18:2 TFA and C18:3 TFA, except for the “DIOXIN” trial where C18:3 TFA > C18:2 TFA. In chicken and rabbit liver samples of the “TRANS” and “OXIDATION” trials, C18:1 TFA were the most abundant, followed by C18:2 TFA and C18:3 TFA, whereas C18:3 TFA > C18:2 in the “DIOXIN” trial. Slight differences were found on the “PAH” trend in livers from both species. The second part of the thesis dealt with the study of lipid oxidation in washed turkey muscle added with different antioxidants. The evaluation on the oxidative stability of muscle foods found that oxidation could be measured by headspace solid phase microestraction (SPME) of hexanal and propanal. To make this method effective, an antioxidant system was added to stored muscle to stop the oxidative processes. An increase in ionic strength of the sample was also implemented to increase the concentration of aldehydes in the headspace. This method was found to be more sensitive than the commonly used thiobarbituric acid reactive substances (TBARs) method. However, after antioxidants were added and oxidation was stopped, the concentration of aldehydes decreased. It was found that the decrease in aldehyde concentration was due to the binding of the aldehydes to muscle proteins, thus decreasing the volatility and making them less detectable.

Relationship between truck ride quality and safety of operations: methodology development. Final report.

National Highway Traffic Safety Administration, Office of Driver and Pedestrian Research, Washington, D.C.

Contract Work Hours and Safety Standards Act, as amended.

Shipping list no.: 87-474-P.