L’évaluation externe de la qualité (EEQ) est un outil indispensable qui permet au laboratoire d’analyse de biologie clinique de surveiller la qualité de ses analyses. Une analyse rétrospective sur 391 893 résultats appartenant à sept analytes fréquemment dosés (glucose, calcium, triglycérides, créatine kinase, hémoglobine, HbA1c et protéines urinaires) a été réalisée sur une période de douze ans, de 1996 à 2007. Pour trois analytes, les résultats accumulés par trois Centres européens suisse, français et belge organisant des EEQ ont été comparés. Une approche statistique simple non paramétrique a été utilisée afin de calculer les performances (CV % et pourcentages de résultats conformes interlaboratoires) en incluant tous les résultats des EEQ, y compris les valeurs aberrantes. Le travail a permis de calculer les performances des appareils en fonction des analytes, de comparer les performances entre les Centres et entre deux types d’utilisateurs – les laboratoires professionnels et les cabinets médicaux – et, enfin, de calculer l’évolution des performances dans le temps. Il en ressort que les performances entre les Centres sont comparables et les appareils des laboratoires professionnels obtiennent de meilleures performances par rapport aux petits analyseurs utilisés dans les cabinets médicaux.Concernant les POCT, les performances ne dépendent pas du type d’utilisateur mais du type de POCT : certains obtiennent des performances comparables aux appareils de laboratoire, d’autres inférieures. Globalement, une amélioration des performances est mesurée pour les deux types d’utilisateurs, pour la plupart des appareils et pour tous les analytes. / The external quality assessment (EQA) is an essential tool that allows medical laboratories to supervise the quality of their analyses. A retrospective analysis on 391.893 results originating from seven frequently measured analytes (glucose, calcium, triglycerides, creatine kinase, haemoglobin, HbA1c, and urinary proteins) was performed over a twelveyear period, from 1996 to 2007. For three analytes, the results accumulated by three European Centres – Swiss, French, and Belgian – organising EQA surveys were compared. A simple non-parametrical statistical approach was used to calculate the performances (inter-laboratory CV% and percentage of correct results) in order to include all EQA results, even aberrant values. The work allowed to calculate the performances of devices for the different analytes, to compare performances among the Centres and among two types of users – professional laboratories and medical offices – and, finally to calculate the evolution of performances over time. It turns out that performances among the Centres are comparable and that professional laboratory devices obtained better performances as compared with small laboratory devices used in medical offices. Concerning POCT devices, performances are not linked to the type of user but to the POCT type : certain types reach the same performances as laboratory devices, while others are below. A general improvement of performances is measured for both types of users, for most devices, and for all the analytes.

<b>Background:</b> External Quality Assessment assesses the quality of the structures, processes and outcomes of health facilities using pre-determined standards. South Africa is introducing a national policy on External Quality Assessment, operationalised by a newly established External Quality Assessment agency: the Office of Health Standards Compliance. This thesis seeks to answer three research questions: What is the relationship between External Quality Assessment and patient outcomes (specifically Healthcare Associated Infections) at the specialist-care facility level in South Africa? What are the facilitators of and barriers to health facility performance (i.e. attainment of compliance with standards) in External Quality Assessment at the district hospital level in South Africa? What has been the experience of External Quality Assessment by frontline healthcare workers at the district hospital level in South Africa? <b>Methods:</b> Three systematic literature reviews are conducted that attempt to identify the existing evidence base for the above-mentioned research questions in the international literature. A convergent parallel mixed methods design is used to answer the research questions, comprising an Interrupted Time Series Analysis and a multiple embedded case study of two pairs of health facilities that had undergone External Quality Assessment by the Office of Health Standards Compliance. The Interrupted Time Series Analysis assesses whether an effectiveness relationship can be demonstrated between External Quality Assessment and the Healthcare Associated Infection Methicillin-resistant Staphylococcus Aureus (MRSA) in eight South African specialist-care hospitals using monthly MRSA data from 2004 to 2014. MRSA is used in this thesis as the proxy patient outcome indicator. In order to answer research questions two and three, I participated in a district hospital External Quality Assessment as a participant observer as well as conducted fifteen in-depth interviews with healthcare workers from two pairs of district hospitals and thirteen in-depth interviews with Office of Health Standards Compliance inspectors. These findings are triangulated with health facility External Quality Assessment reports. <b>Results:</b> No conclusive evidence is found of a relationship between implementation of External Quality Assessment and changes in MRSA. The major theoretical lenses drawn from in the analysis of the qualitative findings are systems thinking theory and regulatory theory. The qualitative research suggests that facilitators of performance in External Quality Assessment in South Africa include strong directional leadership within health facilities, a collaborative organisational culture, a whole systems approach, staff development, incentives, a robust information system and a supportive External Quality Assessment agency. The research also identifies poor alignment of External Quality Assessment standards, under-developed and limited human resources, inadequate decision-making space afforded to district hospital leadership, limited financial resources, the use of penalties and negative staff perceptions of External Quality Assessment as barriers to health facility performance in External Quality Assessment. In unpacking the experiences of South African healthcare workers of External Quality Assessment, this research finds that the work of the Office of Health Standards Compliance is valued by healthcare workers as a potential educational opportunity and is useful in providing the health system with a means to compare health facilities using a standardised tool. The implementation of the Office of Health Standards Compliance's External Quality Assessments requires significant improvement and, in their current form, they have potential unintended negative consequences on healthcare worker motivation as well as potentially, inadvertently encouraging the gaming of External Quality Assessment. <b>Conclusion:</b> The Office of Health Standards Compliance is being set up in such a way that once fully established it will be the primary regulator of quality of care in the South African health system. This thesis attempts to identify some of the strengths and weaknesses of this largely under-researched health system intervention and to contribute to strengthening its implementation.

Submitted by Priscila Nascimento (pnascimento@icict.fiocruz.br) on 2012-11-13T18:17:33Z No. of bitstreams: 1 carlos-renato-calvet.pdf: 572867 bytes, checksum: 445d1b96d9a8d9baadaf7ef3d8852421 (MD5) / Made available in DSpace on 2012-11-13T18:17:33Z (GMT). No. of bitstreams: 1 carlos-renato-calvet.pdf: 572867 bytes, checksum: 445d1b96d9a8d9baadaf7ef3d8852421 (MD5) Previous issue date: 2007 / Fundação Oswaldo Cruz. Instituto de Tecnologia em Imunobiológicos. Rio de Janeiro, RJ, Brasil / Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Rio de Janeiro, RJ, Brasil. / No Brasil, a Leishmaniose Visceral (LV) é uma antropozoonose que representa grave problema de saúde pública, presente em 19 estados da federação, com cerca de 3.500 casos humanos anuais. O agente etiológico da LV é um protozoário do gênero Leishmania, cujos vetores são insetos da sub-família Phlebotominae, sendo o Lutzomyia longipalpisa principal espécie das Américas. O cão é o mais importante reservatório da doença, atuando como hospedeiro doméstico o que torna necessária maior atenção sobre o papel destes animais na transmissão da doença e conseqüente urbanização. O controle da população canina consiste, principalmente, na eliminação de cães infectados e diagnosticados por exames parasitológicos ou sorológicos positivos para a leishmaniose visceral canina (LVC). Resultados sorológicos falso-positivos e falso-negativos podem levar à eutanásia animais supostamente infectados, determinando dados epidemiológicos imprecisos. Bio-Manguinhos produz e distribui os kits de LVC mais utilizados na rede de Laboratório Público do país: incluem-se os testes imunoenzimático (ELISA) e o teste de Imunofluorescência Indireta (IFI). O objetivo desta Dissertação foi pôr em execução um Programa de Avaliação Externa da Qualidade dos testes sorológicos da LVC em instituições localizadas em áreas endêmicas do país. Distribuímos, em outubro de 2006, carta-convite e questionário de cadastramento a 51 instituições responsáveis por realizar o diagnóstico sorológico no país com 78% de adesão (40). Sendo assim, em dezembro de 2006, enviamos um painel sorológico composto por 6 amostras de soro canino, por quatro (4) amostras positivas e duas (2) amostras negativas, todas com certeza diagnóstica confirmadapor ELISA e IFI, junto a um protocolo para o preenchimento dos resultados obtidos. Dos 75% laboratórios (30) que realizaram os exames, 30% (9) foram não-conformes, totalizando 10 erros. Os percentuais de resultados incorretos por metodologia obtidos nesse painel de AEQ-LVC foram 3,7% (4/108 / ELISA) e 3,4% (6/176 / IFI). As respostas dos questionários e dos resultados na sorologia dos painéis foram armazenadas em um banco de dados construído em software estatístico SPSS WIN 11.0. Apoiado nas informações do banco de dados, diversos aspectos foram analisadas (percentil, mediana, desvio-padrão). Além disso, correlações entre realização prévia em Programa de Avaliação Externa da Qualidade (AEQ) foram correlacionadas àsvariáveis de estrutura e processo. A maioria dos laboratórios pertence à Rede Pública, sendo estaduais pouco mais da metade (55%). Apresentam funcionáriosexclusivos para realização da sorologia para LVC em 70% das instituições, com metade dos serviços contando, pelo menos, com um funcionário com instrução superior. Independente do nível de instrução, a experiência dos funcionários na execução do exame de IFI aproxima-se do dobro (em média 6 anos) daquela relativa à execução do ELISA. Quanto às informações estruturais, itens ligados à qualidade demonstraram que 77,5% das instituições possuem Procedimentos Operacionais Padrão (POP); 95,0% afirmaram utilizar equipamento de proteção individual (EPI) emais da metade (60%) dos laboratórios não calibra equipamentos e dentre esses um terço (31,3%) o faz com periodicidade irregular ou acima da anual. Por intermédio de painéis sorológicos, o AEQ-LVC pretende contribuir como importante instrumento para melhoria do desempenho dos laboratórios públicos. / Visceral leishmaniasis (VL) is one anthropozoonose that represents a serious problem of public health in Brazil with 3.500 new annual cases in 19 states of the country. The etiological agent of VL is a protozoa of the genus Leishmania, whose vectors are insects of the sub-family Phlebotominae, being the Lutzomyia longipalpis, the main species found in the Americas. The dog is the most important reservoir of the parasite acting as a domestic host, demanding agreater attention on the role of these animals in the transmission of the illness and its consequent urbanization. The control of the canine population consists mainly inthe elimination of infected dogs, diagnosed by parasitological examinations or positive serological tests for canine visceral leishmaniasis (CVL). False-positive and false-negative serological results may lead to the euthanasia of supposedly infected animals and the attainment of imprecise epidemiological data. Bio-Manguinhos produces and distributes the most consumed kits for CVL used in Brazil’s public laboratory network including immunoenzyme (ELISA) and indirect immunofluorescence (IFI) tests. The objective of the present study was to initiate a Program of External Quality Assessment (EQA) for CVL serological tests, in institutions located in endemic areas of the country. In October 2006, an invitation letter together with anenrollment form was sent to 51 institutions responsible for the serological diagnosis in the country to which 78% (40) had adhered. In December 2006, along with a protocol to be fulfilled with the results a serological panel was sent containing: four (4) positive and two (2) negative samples of canine serum, all of them confirmed by ELISA and IFI. Of the 30 (75%) laboratories that performed the exams, 9 (30%) werenot in agreement, totalizing 10 errors. The percentage of incorrect results by methodology obtained for this EQA-CVL panel was 3,7% (4/108) for ELISA and 3,4% (6/176) for IFI. The information obtained from the serological panel results was stored in a data bank, constructed in SPSS WIN 11.0 statistical software. Based on this data bank, some statistical were analyzed. Furthermore, correlations between previous programs of external quality assessment (EQA) were performed to compare structural and process variables. The majority of the laboratories belong to the public network with more than a half (55%) belonging to the state. Exclusive employees that perform CVL serology were found in 70% of the institutions and half of the servicespossess at least one employee with superior instruction. Independently of the instruction level, the employees experience on IFI is about 2 times greater (6 years) than thatrelated to ELISA tests. Concerning structural information, quality related items showed that 77,5% of the institutions possess Standard Operating Procedures (SOP), 95,0% use Individual Protection Equipment (IPE), more than a half (60%) do not calibrate equipments and amongst the ones that do the calibration, one-third (31,3%)make it with irregularly or over annual periodicity. Through serological panels, theEQA-CVL might contribute as an important instrument to improve the performance of public laboratories.

Abstract Point-of-care testing (POCT) is defined as laboratory tests performed outside the traditional clinical laboratory close to the patient at the time and place where care is received, such as hospitals and healthcare centers. The main reason for the use of POCT is that they provide rapid results and enable prompt interventions, with hopefully improved patient outcomes. All phases of laboratory procedure are included in POCT offering many opportunities for errors, which can influence on patients’ treatment. The measurements are more often performed by nurses than by laboratory professionals. These nurses have different kinds of professional backgrounds, e.g. public health nurses, registered and practical nurses, with minimal or no knowledge of laboratory procedures. The aim of the study was to develop a two-step training and management strategy for nurses to do POCT in hospital and primary healthcare center. In accordance with the strategy, with reasonable investment of laboratory resources, designated contact nurses were first trained in POCT by laboratory professionals, after which the contact nurses trained other nurses in POCT their respective units. Blood glucose, the most common point-of-care (POC) test, was chosen as an example to investigate the influence of training on the quality of the test performed by nurses. The quality of blood glucose measurements was studied by analyzing the control results obtained by nurses and biomedical laboratory scientists (BLSs). The study participants included nurses who were either untrained or trained to do POCT by using the developed interactive two-step training strategy. In conclusion, the nurses trained by using interactive two-step strategy achieved near-similar quality of blood glucose measurements as BLSs. The good quality of glucose measurements, once achieved by training, was also sustained in the long-term. / Tiivistelmä Määritelmän mukaan vieritutkimuksiksi kutsutaan laboratoriotutkimuksia, joita tehdään perinteisen laboratorion ulkopuolella, tarvittaessa lähellä potilasta sairaalassa ja perusterveydenhuollon alueella. Pääasiassa vieritutkimuksia tehdään silloin kun tulos halutaan saada nopeasti ennen hoitopäätöstä tai tulevaa toimenpidettä. Vieritutkimusten tekeminen sisältää kaikki laboratoriotyön vaiheet ja jokaisessa vaiheessa on mahdollisuus tehdä virheitä, jotka voivat vaikuttaa potilaiden hoitoon. Laboratorioammattilaisten sijaan määrityksiä tekevät yhä useammin hoitajat sairaalan eri yksiköissä ja perusterveydenhuollon alueella. Näillä hoitajilla on erilainen ammatillinen peruskoulutus, kuten perushoitajan tai sairaanhoitajan koulutus, ja heillä on vähän tai ei ollenkaan tietoa laboratoriomenetelmistä. Tämän tutkimuksen tarkoituksena oli kehittää hoitajien vieritutkimustoimintaan koulutus- ja hallintomalli, joka toimisi sekä sairaalassa että terveyskeskuksessa. Strategian perusteena oli käyttää suhteellisen vähän laboratorioresursseja ja päästä silti hyvään laadulliseen lopputulokseen. Strategiaksi valittiin kaksiportainen, vuorovaikutteinen koulutusmalli, jossa laboratorioammattilaiset kouluttivat sairaalan ja perusterveydenhuollon yksiköissä ns. yhdyshenkilöt, jotka puolestaan kouluttivat edelleen oman yksikkönsä muut hoitajat tekemään vieritutkimuksia. Veren glukoosimääritys, joka on yleisin vieritutkimus, valittiin esimerkkitutkimukseksi tutkittaessa koulutuksen vaikutusta hoitajien tekemien vieritutkimusten laatuun. Veren glukoosimääritysten laatutasoa tutkittiin analysoimalla hoitajien ja laboratoriohoitajien tekemien kontrollinäytteiden tuloksia. Tutkimukseen osallistui hoitajia, jotka oli koulutettu kehitetyllä vuorovaikutteisella kaksiportaisella koulutusstrategialla vieritutkimusten tekemiseen, sekä hoitajia, jotka eivät olleet saaneet vastaavaa koulutusta. Koulutusmallin avulla hoitajien suorittamien vieritutkimusten laatu parani ja he saavuttivat lähes saman laatutason kuin laboratoriohoitajat. Hyvä, kerran saavutettu glukoosimääritysten laatutaso säilyi myös pitkällä aikajaksolla.

The purpose of quality control within internal auditing functions is to ensure that internal auditing functions add value by providing a quality service. The aim of this research project was to investigate the importance of quality control within internal auditing functions as prescribed by the standards and guidelines of the internal auditing profession. It was also attempted to determine to what extent these standards and guidelines are applied within internal auditing functions in South Africa. The study concluded that quality control is not adequately applied within all internal auditing functions in South Africa. Compliance with the internal auditing standards (implemented on 1 January 2002) should contribute to improve the situation. The internal auditors&#8217; professional body should motivate internal auditing functions to exercise quality control according to the internal auditing standards. This will uplift the image of the internal auditing profession and ensure the future existence of internal auditing functions. / Auditing / M.Comm.

The purpose of quality control within internal auditing functions is to ensure that internal auditing functions add value by providing a quality service. The aim of this research project was to investigate the importance of quality control within internal auditing functions as prescribed by the standards and guidelines of the internal auditing profession. It was also attempted to determine to what extent these standards and guidelines are applied within internal auditing functions in South Africa. The study concluded that quality control is not adequately applied within all internal auditing functions in South Africa. Compliance with the internal auditing standards (implemented on 1 January 2002) should contribute to improve the situation. The internal auditors&#8217; professional body should motivate internal auditing functions to exercise quality control according to the internal auditing standards. This will uplift the image of the internal auditing profession and ensure the future existence of internal auditing functions. / Auditing / M.Comm.

The use of hair and oral fluid for drugs of abuse testing has increased over the last years. For this reason, the assurance that results provided using these matrices are reliable and error-free is needed. The objective of this thesis is to develop tools to assess the quality of results provided by laboratories analysing drugs of abuse in hair and in oral fluid and to evaluate the effect on the quality of results of different actions carried out. For this reason, intercomparison exercises have been organized and some studies have been performed to develop appropriate quality control materials. Regarding the analysis of drugs of abuse in hair, nine different intercomparison exercises have been organized. The evaluation of qualitative and quantitative results reported by laboratories together with the study of the methodology used, has led to know the quality of the results, to identify the sources of error and to know the corrective actions that should be developed. Concerning the quality control material, these exercises have enabled to know the influence on the results of the type of hair used to perform the analysis. Concerning the analysis of drugs of abuse in oral fluid, a method has been developed to identify and quantify 6-monoacetyl morphine, morphine, codeine, cocaine and benzoylecgonine in oral fluid samples. On the other hand, stability studies of the main drugs of abuse in oral fluid have been done to establish the optimal preparation, transport and storage conditions, and finally, two intercomparison exercises have been conducted to know the performance of analytical laboratories when analysing drugs of abuse in oral fluid and to know the stability of some drugs of abuse in two commercial collection devices. / La creixent utilització del cabell i del fluid oral per a l’anàlisi de drogues d’abús, ha portat a la necessitat d’assegurar que els resultats obtinguts utilitzant aquestes matrius són fiables i lliures d’error. L’objectiu d’aquesta tesi és desenvolupar eines que permetin avaluar la qualitat dels resultats dels laboratoris que analitzen drogues d’abús en cabell i en fluid oral i avaluar l’efecte de diferents accions sobre la qualitat final dels resultats. Per això s’han organitzat exercicis interlaboratori i s’han realitzat estudis per desenvolupar material d’assaig adequat. Pel que fa a l’anàlisi de drogues d’abús en cabell, s’han realitzat nou exercicis interlaboratori. A través de l’avaluació dels resultats qualitatius i quantitatius informats pels laboratoris i mitjançant l’estudi de la metodologia emprada, ha estat possible conèixer la qualitat dels resultats obtinguts, detectar les fonts d’error i conèixer quines mesures correctives caldria desenvolupar. Pel que fa al material d’assaig, aquests exercicis han permès conèixer la influència que té, en els resultats, el tipus de cabell del qual es parteix per realitzar l’anàlisi. Pel que fa a l’anàlisi de drogues d’abús en fluid oral, s’ha desenvolupat i validat un mètode analític que ha permès identificar i quantificar 6-monoacetil morfina, morfina, codeïna, cocaïna i benzoïlecgonina en mostres de fluid oral. Per altra banda, s’han realitzat estudis d’estabilitat de les principals drogues en fluid oral que han permès establir les condicions òptimes de preparació, transport i conservació del material d’assaig i, per últim, s’han realitzat dos exercicis interlaboratori que han permès conèixer la qualitat dels resultats analítics obtinguts pels laboratoris i també l’estabilitat de les drogues en dos dispositius de recollida comercials.