Práticas de auditoria no sistema único de saúde: uma revisão integrativa / Prácticas de auditoría en el sistema único de salud: una revisión integrativa / Auditing practices in the Brazilian unified health system: an integrative literature review

Objective: The study's purpose has been to analyze the auditing practices in the Sistema Único de Saúde (SUS) [Brazilian Unified Health System]. Methods: It is an integrative literature review that was carried out in the Literatura Latino-Americana e do Caribe em Ciências da Saúde (LILACS) [Latin American and Caribbean Literature in Health Sciences], Virtual Health Library (VHL), and Web of Science databases. By using the inclusion and exclusion criteria, 12 scientific articles were selected for in-depth analysis. Results: The findings demonstrate the political and institutional advances regarding to the auditing practices in the SUS. There have been also identified many challenges that must be overcome in order to support such practices, such as the need to qualify the tools of the National Audit Department from the SUS and to improve the communication between State, Municipal, and Federal auditing. Conclusion: Auditing practices in the SUS are still under development, then requiring more studies and dissemination, aiming to bring contributions to both practice and the academic milieu

Objetivo: Analisar as práticas de auditoria no Sistema Único de Saúde (SUS). Métodos: Trata-se de uma revisão integrativa de literatura realizada na Biblioteca Virtual em Saúde (BVS), Literatura Latino-Americana e do Caribe em Ciências da Saúde (Lilacs), e Web of Science. Ao total, utilizando-se os critérios de inclusão e exclusão selecionou-se 12 artigos científicos para análise. Resultados: Os resultados apontam avanços políticos e nas instituições com relação as práticas de auditoria no SUS. Identificam-se também muitos desafios para fortalecer tais práticas, como a necessidade de qualificar as ferramentas do Departamento Nacional de Auditoria do SUS e melhorar a comunicação entre o componente, estadual, municipal e federal de auditoria. Conclusão: As práticas de auditoria no SUS estão em construção, necessitando de mais estudos e divulgação, afim de que traga contribuições para a prática e o meio acadêmico

Objetivo: Analizar las prácticas de auditoría en el Sistema Único de Salud (SUS). Método: Se trata de una revisión integrativa de literatura realizada en la Biblioteca Virtual en Salud (BVS), Literatura Latinoamericana y del Caribe en Ciencias de la Salud (Lilacs), y Web of Science. Al total, utilizando los criterios de inclusión y exclusión se seleccionaron 12 artículos científicos para análisis. Resultados: Los resultados apuntan avances políticos y en las instituciones con relación a las prácticas de auditoría en el SUS. Se identifican también, muchos desafíos para fortalecer tales prácticas, como la necesidad de calificar las herramientas del Departamento Nacional de Auditoría del SUS y mejorar la comunicación entre el componente, estatal, municipal y municipal, federal de auditoría. Conclusión: Las prácticas de auditoría en el SUS están en construcción, necesitando más estudios y divulgación, a fin de que traiga contribuciones para la práctica y el medio académico

Correcting India's Chronic Shortage of Drug Inspectors to Ensure the Production and Distribution of Safe, High-Quality Medicines.

BACKGROUND: Good drug regulation requires an effective system for monitoring and inspection of manufacturing and sales units. In India, despite widespread agreement on this principle, ongoing shortages of drug inspectors have been identified by national committees since 1975. The growth of India's pharmaceutical industry and its large export market makes the problem more acute. METHODS: The focus of this study is a case study of Maharashtra, which has 29% of India's manufacturing units and 38% of its medicines exports. India's regulations were reviewed, comparing international, national and state inspection norms with the actual number of inspectors and inspections. Twenty-six key informant interviews were conducted to ascertain the causes of the shortfall. RESULTS: In 2009-2010, 55% of the sanctioned posts of drug inspectors in Maharashtra were vacant. This resulted in a shortfall of 83%, based on the Mashelkar Committee's recommendations. Less than a quarter of the required inspections of manufacturing and sales units were undertaken. The Indian Drugs and Cosmetics Act and its Rules and Regulations make no provisions for drug inspectors and workforce planning norms, despite the growth and increasing complexity of India's pharmaceutical industry. CONCLUSION: The Maharashtra Food and Drug Administration (FDA) falls short of the Mashelkar Committee's recommended workforce planning norms. Legislation and political and operational support are required to produce needed changes.

Manufacturing of Plasma-Derived Medicinal Products: Qualification Process of Plasma Suppliers.

Manufacturers of human plasma-derived products ensure, through their qualification departments, the quality and safety of human plasma-the biological starting material of the industrial fractionation process. The qualification department has established written procedures to approve the plasma supplier (i.e., initial qualification) according to current regulations and to the manufacturer's plasma specifications. Once the plasma supplier is approved, a periodical assessment is necessary (i.e., continuous qualification) to guarantee the level of compliance. In addition, a signed quality agreement between the plasma supplier and the manufacturer defines the duties and the responsibilities of both parties. The qualification department implements the following requirements to ensure the quality of plasma from suppliers: (i) a regular audit program to confirm the satisfactory initiation of the quality arrangements and (ii) monitoring of the quality and safety of plasma including critical quality parameters. For several years, the Grifols Qualification Department has worked with several plasma suppliers of the European Union (EU) and has performed a detailed, continuous assessment of the audits, deviations, operational incidences, epidemiological data, and quality controls. In this article, we will report data from this Grifols assessment from 2010 through 2013 on plasma suppliers from four EU countries. In the future, additional data will be collected and studied to confirm and verify the conclusions and trends observed in this study.

Evaluación de los recursos de información en el Centro de Estudio, Documentación e Información de Medicamentos, Villa Clara / Assessment of information resources in the Center of Study, Documentation and Drug Information in Villa Clara province

OBJETIVO: evaluar los recursos de información disponibles en el Centro de Estudio, Documentación e Información de Medicamentos (CEDIMED). MÉTODOS: se identificaron aquellas fuentes, servicios y sistemas que pudieran llegar a alcanzar la categoría de entidad o recurso de información dentro del CEDIMED, empleando la metodología INFOMAP. Se recolectaron datos sobre el costo de los recursos identificados y se desarrolló un ordenamiento de estos según su característica. Se determinó el índice de valor para cada ERIs y se elaboraron las matrices de usuario, gerente y suministradores, lo que posibilitó conocer el rol de cada miembro de la organización con respecto a los recursos de información. Se analizó la variable fondos de información, en la que se estudiaron un total de 15 indicadores. RESULTADOS: se identificaron 47 entidades o recursos de información disponibles en el centro; de estas 36 internas y 11 externas. Los fondos documentales con los que cuenta el CEDIMED no presentaron un alto grado de actualización; sin embargo, las temáticas contenidas en estos, resultaron altamente pertinentes a las funciones de este tipo de organización. Alrededor de la mitad de los indicadores analizados fue evaluado de excelente; sin embargo, la variable fondos de información fue regular. CONCLUSIONES: todo centro o servicio de información sobre medicamentos debe contar con recursos de información de calidad y fácil acceso por los usuarios; así como establecer una política para el desarrollo de los fondos y la realización de estudios sobre el uso de las diversas colecciones disponibles en la institución(AU)

OBJECTIVE: to evaluate the information resources available at the Center of Study, Documentation and Information on Drugs (CEDIMED). METHODS: identification of those sources, services and systems that might attain the category of entity or of information resource within CEDIMED by using the INFOMAD methodology. Data on the cost of identified resources were collected and ordered according to their characteristics. The value index was determined for each ERI and the user, manager and supplier matrices were prepared, all of which made it possible to know the role of each member of the organization in relation to the information resources. The variable called information stocks was analyzed including the study of 15 indicators. RESULTS: forty seven information entities or resources were available at the center, 36 domestic and 11 external. The documentary stocks of CEDIMED were not highly updated; however, their topics were highly relevant for the functions of this type of organization. The evaluation of almost half of the analyzed indicators was excellent but the variable information stocks were rated as regular. CONCLUSIONS: every information center or service on drugs should have quality easy-to-access resources for users and should also set a policy aimed at developing the stocks and at carrying out studies on the use of the various collections located in the institution(AU)

Improved incident reporting following the implementation of a standardized emergency department peer review process.

OBJECTIVE: Incident reporting is an important component of health care quality improvement. The objective of this investigation was to evaluate the effectiveness of an emergency department (ED) peer review process in promoting incident reporting. DESIGN: An observational, interrupted time-series analysis of health care provider (HCP) incident reporting to the ED during a 30-month study period prior to and following the peer review process implementation and a survey-based assessment of physician perceptions of the peer review process' educational value and its effectiveness in identifying errors. SETTING: Large, urban, academic ED. PARTICIPANTS AND INTERVENTIONS: HCPs were invited to participate in a standardized, non-punitive, non-anonymous peer review process that involved analysis and structured discussion of incident reports submitted to ED physician leadership. MAIN OUTCOME MEASURES: Monthly frequency of incident reporting by HCPs and physician perceptions of the peer review process. RESULTS: HCPs submitted 314 incident reports to the ED over the study period. Following the intervention, frequency of reporting by HCPs within the hospital increased over time. The frequencies of self-reporting, reporting by other ED practitioners and reporting by non-ED practitioners within the hospital increased compared with a control group of outside HCPs (P = 0.0019, P = 0.0025 and P < 0.0001). Physicians perceived the peer review process to be educational and highly effective in identifying errors. CONCLUSIONS: The implementation of a non-punitive peer review process that provides timely feedback and is perceived as being valuable for error identification and education can lead to increased incident reporting by HCPs.

A risk-based auditing process for pharmaceutical manufacturers.

The purpose of this article is to share ideas on developing a risk-based model for the scheduling of audits (both internal and external). Audits are a key element of a manufacturer's quality system and provide an independent means of evaluating the manufacturer's or the supplier/vendor's compliance status. Suggestions for risk-based scheduling approaches are discussed in the article. LAY ABSTRACT: Pharmaceutical manufacturers are required to establish and implement a quality system. The quality system is an organizational structure defining responsibilities, procedures, processes, and resources that the manufacturer has established to ensure quality throughout the manufacturing process. Audits are a component of the manufacturer's quality system and provide a systematic and an independent means of evaluating the manufacturer's overall quality system and compliance status. Audits are performed at defined intervals for a specified duration. The intention of the audit process is to focus on key areas within the quality system and may not cover all relevant areas during each audit. In this article, the authors provide suggestions for risk-based scheduling approaches to aid pharmaceutical manufacturers in identifying the key focus areas for an audit.

Experiences of using the GMP audit preparation tool in pharmaceutical contract manufacturer audits.

BACKGROUND: Use of external contractors is nowadays inevitable in the pharmaceutical industry. Therefore the amount of current good manufacturing practice audits has been increasing. During the audit, a large amount of items should be covered in a limited amount of time. Consequently, pharmaceutical companies should have systematic and effective ways to manage and prepare for the audits. This study is a continuation to the earlier study, where a tool for the preparation of cGMP audit was developed and its content was validated. The objective of this study was to evaluate the usefulness of the developed tool in audit preparation and during the actual cGMP audit. METHOD: Three qualitative research methods were used in this study (observation, interviews, and opinion survey). First, the validity of the information given through the tool was examined by comparing the responses to the actual conditions observed during the contract manufacturer audits (n = 15). Additionally the opinions of the contract manufacturers of the tool were gathered (n = 10) and the auditors were interviewed (n = 2). RESULTS: The developed tool was proven to be useful in audit preparation phase from both the auditor's and the contract manufacturers' point of view. Furthermore, using the tool can also save some time when performing the audit. CONCLUSION: The results show that using the tool can give significant support in audit preparation phase and also during the actual audit.

Comparison of administrative-only versus administrative plus chart review data for reporting HEDIS hybrid measures.

OBJECTIVE: Health plans, medical groups, and commercial vendors are using administrative data to measure clinical performance at the plan or physician level. We compared results of using administrative claims data alone versus administrative data combined with chart review for selected Healthcare Effectiveness Data and Information Set (HEDIS) measures. STUDY DESIGN: Cross-sectional comparison of health plan performance rates using different methods of data collection. METHODS: We analyzed data reported by 283 commercial managed care plans in 2004 and 2006 for 15 HEDIS hybrid measures. Hybrid specifications included the use of administrative data supplemented with medical record review and required plans to report performance rates based on administrative data only and for administrative data supplemented with chart review. We calculated differences in rates and changes in quartile rankings of health plans between the 2 reported rates. RESULTS: Performance rates using administrative data alone were substantially lower than rates using combined data (average difference of 20.4 percentage points). On average, more than half of the plans had different quartile rankings based on administrative-only rates versus combined data rates. Measures relying on laboratory claims or laboratory results had the largest discrepancies. CONCLUSIONS: Currently available health plan administrative data alone do not appear to provide sufficiently complete results for ranking health plans on HEDIS quality-of-care measures with hybrid specifications. The results suggest that reporting of clinical performance measures using administrative data alone should include prior testing and reporting on the completeness of data, relative rates, and changes in rankings compared with the use of combined administrative data and chart review.

The role of performance referents in health services organizations.

Health care executives rely on a variety of information sources to evaluate organizational performance. This is because outcomes take on meaning only when compared to referents, or standards of comparison. Although performance referents are widely acknowledged to be important, consideration of their relevance to health services management has been minimal. To address this need, we draw on organizational theories and observations from health services organizations to describe the use of performance referents and to provide insights about the possible effects of performance referent selection on strategic choices and performance.

Managed care report cards: evaluating those who evaluate physicians.

Managed care organizations are evaluating doctors, but how well are these organizations being evaluated themselves? This proposal for a report card identifies the necessary features of competent and sophisticated managed care enterprises. It is designed so that purchasers, providers, and patients may appreciate the more substantive issues associated with success in health care management.

Indicator-based systems of performance management in the National Health Service: a comparison of the perceptions of local- and national-level managers.

Historically, the UK Government has policed the use of National Health Service (NHS) resources through the centralization of control. With the majority of resource-draining decisions being taken by clinicians, however, professional financial accountability is becoming more important within the NHS management structure. Variations in clinical performance can be monitored through the use of performance indicators, although these are not without their problems. The use of league tables of such indicators in the national press is now infamous and there is much anecdotal evidence about the intraorganizational conflict arising from the use of such tables. A questionnaire survey and interview study of clinical directors, clinical service directors and business managers in several Scottish NHS Trusts was undertaken to ascertain the perceptions of local-level managers on the issue of performance indicators. Interviews were also carried out with a number of personnel in the Scottish Office Department of Economics and Information, the Division of Health Gain and the Finance Directorate. This paper explores the differences between the perceptions of the managers at these two levels of the NHS with regards to issues of performance measurement, intraorganizational conflict and corporate vision.