Servicio Autónomo de Contraloría Sanitaria

Ente adscrito al Ministerio del Poder Popular para la Salud responsable de la implementación del sistema nacional de regulación, registro, notificación, autorización, habilitación, evaluación, acreditación, certificación, análisis, supervisión, inspección, vigilancia, control, investigación, asesoramiento y sanción de los establecimientos, procesos y productos alimenticios, medicamentos, drogas, cosméticos, equipos y materiales médicos de uso y consumo humano con base a las políticas y normativas sanitarias vigentes, así como regular la prestación de servicios en el ámbito de la salud humana, a través del registro, control, certificación y recertificación de los profesionales de salud.​

Report from the GHPP-BloodTrain inspection workshop in Harare the 20th to the 24th of May 2019.

During the training workshop on Inspection of Blood Establishments, which was hosted by the PEI GHPP BloodTrain in Harare from the 20th to the 24th of May 2019, participants from the National Regulatory Authorities from seven Sub-Sahara African countries presented their current experiences related to regulation and inspection of blood establishments in their respective countries. While in all seven countries regulation and inspection of conventional medicinal products manufacturer is performed, the regulatory situation of blood and blood components as well as inspection of blood establishments is still heterogeneous.

Transforming an Academic Radiochemistry Facility for Positron Emission Tomography Drug cGMP Compliance.

In light of the United States Food and Drug Administration (FDA) requirement of 21 CFR 212 current Good Manufacturing Practice (cGMP) for FDA-approved position emission tomography (PET) drugs, the University of California Los Angeles (UCLA) Biomedical Cyclotron (BMC) transformed from a pre-cGMP era academic cyclotron and radiochemistry facility to a current cGMP-compliant PET drug manufacturer. In this article, we share the financial and regulatory compliance aspects of the "transformation" required to develop a sustainable quality system to support the production of two PET drugs under Abbreviated New Drug Applications (ANDAs).

Scores on doors: restaurant hygiene ratings and public health policy.

This paper seeks to contribute to the ongoing policy debate about mandated posting of health department hygiene ratings for establishments that sell food. Posted restaurant hygiene ratings, or 'scores on doors,' exemplify a public health transparency policy in the form of words, letters, numbers, or symbols displayed at entrances to food-serving establishments summarizing their most recent health inspection. After describing the scope of restaurant hygiene inspections and the problem of foodborne illness, this paper critically examines the 'mandation' debate on economic, practical, ethical, and legal aspects. It concludes that mandated posting of hygiene ratings, if done properly, is a potentially effective public policy that fosters transparency, population health, and informed consumer choice.

INAHTA IMPACT STORY: LEGISLATIVE AND ACCREDITATION REQUIREMENTS FOR OFFICE-BASED SURGERY IN AUSTRALIA.

BACKGROUND: There is growing trend for some surgical procedures previously performed in hospitals to be done in alternative settings, including office-based facilities. There has been some safety concerns reported in the media, which document serious adverse events following procedures performed in an office-based setting. To understand the current regulatory oversight of surgery in this setting ASERNIP-S conducted a review of the legislative and accreditation process governing these facilities in Australia. METHODS: Using rapid review methodology, internet searches targeted government Web sites for relevant publicly-available documents. Use of consolidated versions of legislative instruments ensured currency of information. Standards were sourced directly from the issuing authorities or those that oversee the accreditation process. RESULTS: Within Australia, healthcare facilities for surgery and their licensing are defined by each state and territory, which results in significant jurisdictional variation. These variations relate to the need for anesthesia beyond conscious sedation and listing of procedures in legislative instruments. In 2013, Australia adopted National Safety and Quality Health Service standards (NSQHS standards) for the accreditation of hospitals and day surgery centers; however, there is no NSQHS standard for office-based facilities. The main legislative driver for compliance is access to reimbursement schemes for service delivery. CONCLUSIONS: The legislative and accreditation framework creates a situation whereby healthcare facilities that provide services outside the various legal definitions of surgery and those not covered by a reimbursement scheme, can operate without licensing and accreditation oversight. This situation exposes patients to potential increased risk of harm when receiving treatment in such unregulated facilities.

Standard operating procedure: implementation, critical analysis, and validation in the Audiology Department at CESTEH/Fiocruz.

PURPOSE: Evaluate three standard operational procedures (SOPs), regarding the application of the brainstem auditory evoked potential (BAEP) test, implemented by the Audiology Department of the Center for Studies in Occupational Health and Human Ecology (CESTEH) through the application of a questionnaire and to verify whether the SOPs are effective and assess the necessity for improvement. METHODS: The study was conducted in three phases: in the first phase, eight speech-language pathologists and seven physicians, with no experience in BAEP, were instructed to read and perform each SOP, eventually all individuals evaluated the SOPs by responding to a questionnaire; in the second phase, the questionnaires were analyzed and the three SOP texts were reviewed; in the third phase, nine speech-language pathologists and six physicians, also with no experience in BAEP, read and re-evaluated the reviewed SOPs through a questionnaire. RESULTS: In the first phase, difficulties in understanding the texts were found, raising doubts about the procedures; however, every participant was able to perform the procedure as a whole. In the third phase, after the review, all individuals were able to perform the procedures appropriately and continuously without any doubts. CONCLUSION: The assessment of the SOPs by questionnaires showed the need for adaptation in the texts. After the texts were reviewed according to the suggestions of the health professionals, it was possible to observe that the SOPs assisted in the execution of the task, which was conducted without any difficulties or doubts, being regarded effective and ensuring quality to the service offered.

Standard operating procedure: implementation, critical analysis, and validation in the Audiology Department at CESTEH/Fiocruz

ABSTRACT Purpose Evaluate three standard operational procedures (SOPs), regarding the application of the brainstem auditory evoked potential (BAEP) test, implemented by the Audiology Department of the Center for Studies in Occupational Health and Human Ecology (CESTEH) through the application of a questionnaire and to verify whether the SOPs are effective and assess the necessity for improvement. Methods The study was conducted in three phases: in the first phase, eight speech-language pathologists and seven physicians, with no experience in BAEP, were instructed to read and perform each SOP, eventually all individuals evaluated the SOPs by responding to a questionnaire; in the second phase, the questionnaires were analyzed and the three SOP texts were reviewed; in the third phase, nine speech-language pathologists and six physicians, also with no experience in BAEP, read and re-evaluated the reviewed SOPs through a questionnaire. Results In the first phase, difficulties in understanding the texts were found, raising doubts about the procedures; however, every participant was able to perform the procedure as a whole. In the third phase, after the review, all individuals were able to perform the procedures appropriately and continuously without any doubts. Conclusion The assessment of the SOPs by questionnaires showed the need for adaptation in the texts. After the texts were reviewed according to the suggestions of the health professionals, it was possible to observe that the SOPs assisted in the execution of the task, which was conducted without any difficulties or doubts, being regarded effective and ensuring quality to the service offered.

An Assessment Model for Evaluating Outcomes in Federally Qualified Health Centers' Dental Departments: Results of a 5 Year Study.

PURPOSE: The purpose of this report was to establish baseline data on 10 oral health performance indicators over 5 fiscal years (2007 to 2008 through 2011 to 2012) for an Iowa health center. The baseline data provides an assessment model and reports outcomes based on the use of the model. Performance indicators show evidence of provider performance, accountability to stakeholders and provide the benchmarks required for dental management to develop future goals to improve oral health outcomes for atrisk populations. METHODS: Using descriptive statistic, this report extrapolated data from the Iowa Health Center's computer management systems software, HealthPro, and Centricity electronic medical records, and analyzed using IBM® SPSS® 19. This report describes the change in utilization for number and type of visits for uninsured and Medicaid patients over 5 fiscal years (a fiscal year is measured from November 1 through October 31). RESULTS: The number of patients receiving at least 1 dental visit in a measurement year showed n=81,673 procedures with 21% (17,167) being unduplicated patients. Preventive averaged 46%, restorative 18%, urgent care 22% and other procedures 14%. CONCLUSION: Federally qualified health centers (FQHCs) with a dental component serve populations with the greatest health disparities. This population includes ethnic and racial minorities, uninsured, underinsured, rural residents, Medicaid and Medicare. Establishing baseline data for FQHCs provides a foundational tool that will allow dental management to analyze successes as well as deficiencies in the goal to provide increased utilization to oral health care for at-risk populations.

An Assessment Model for Evaluating Outcomes in Federally Qualified Health Centers' Dental Departments: Results of a 5 Year Study.

PURPOSE: The purpose of this report was to establish baseline data on 10 oral health performance indicators over 5 fiscal years (2007 to 2008 through 2011 to 2012) for an Iowa health center. The baseline data provides an assessment model and reports outcomes based on the use of the model. Performance indicators show evidence of provider performance, accountability to stakeholders and provide the benchmarks required for dental management to develop future goals to improve oral health outcomes for at-risk populations. METHODS: Using descriptive statistic, this report extrapolated data from the Iowa Health Center's computer management systems software, HealthPro, and Centricity electronic medical records, and analyzed using IBM® SPSS® 19. This report describes the change in utilization for number and type of visits for uninsured and Medicaid patients over 5 fiscal years (a fiscal year is measured from November 1 through October 31). RESULTS: The number of patients receiving at least 1 dental visit in a measurement year showed n=81,673 procedures with 21% (17,167) being unduplicated patients. Preventive averaged 46%, restorative 18%, urgent care 22% and other procedures 14%. CONCLUSION: Federally qualified health centers (FQHCs) with a dental component serve populations with the greatest health disparities. This population includes ethnic and racial minorities, uninsured, underinsured, rural residents, Medicaid and Medicare. Establishing baseline data for FQHCs provides a foundational tool that will allow dental management to analyze successes as well as deficiencies in the goal to provide increased utilization to oral health care for at-risk populations.

Examination of the order of incubation for the recovery of bacteria and fungi from pharmaceutical-grade cleanrooms.

A study was undertaken to compare microbial recoveries from pharmaceutical-grade cleanrooms using two different incubation regimes and a general-purpose agar (Tryptone Soy Agar). One temperature regime (A) incubated plates first at 30 degrees C to 35 degrees C, followed by 20 degrees C to 25 degrees C; the second temperature regime (B) began the incubation with plates at 20 degrees C to 25 degrees C, followed by 30 degrees C to 35 degrees C. The experimental outcomes demonstrated that there was no significant difference with the total microbial count when measured using a t-test (0.05 significance level; 95% confidence interval). However, with the recovery of fungi, the second incubation regime (B), which began with the lower 20 degrees C to 25 degrees C temperature, produced higher incidents and numbers of fungi. While this finding might provide the basis for adopting one incubation regime over another, a review of the types of cleanrooms recovering fungi suggests that fungal incidents are low, and they are more often confined to specific areas. Thus, as an alternative, incubation regimes could be varied to suit different cleanroom environments or a selective mycological agar adopted for specific areas.

A survey on auditing, quality assurance systems and legal frameworks in five selected slaughterhouses in Bulawayo, south-western Zimbabwe.

The purpose of this study was to explore the audits, quality assurance (QA) programmes and legal frameworks used in selected abattoirs in Zimbabwe and slaughterhouse workers' perceptions on their effectiveness. Data on slaughterhouse workers was gathered through a self-completed questionnaire and additional information was obtained from slaughterhouse and government records. External auditing was conducted mainly by the Department of Veterinary Public Health with little contribution from third parties. Internal auditing was restricted to export abattoirs. The checklist used on auditing lacked objective assessment criteria and respondents cited several faults in the current audit system. Most respondents (> 50.0%) knew the purposes and benefits of audit and QA inspections. All export abattoirs had QA programmes such as hazard analysis critical control point and ISO 9001 (a standard used to certify businesses' quality management systems) but their implementation varied from minimal to nil. The main regulatory defect observed was lack of requirements for a QA programme. Audit and quality assurance communications to the selected abattoirs revealed a variety of non-compliances with most respondents revealing that corrective actions to audit (84.3%) and quality assurance (92.3%) shortfalls were not done. A high percentage of respondents indicated that training on quality (76.8%) and regulations (69.8%) was critical. Thus, it is imperative that these abattoirs develop a food safety management system comprising of QA programmes, a microbial assessment scheme, regulatory compliance, standard operating procedures, internal and external auditing and training of workers.

Cuatro claves para una instalación hospitalaria sana y eficiente / No disponible

Una instalación hidráulica capaz de proporcionar el confort y la eficiencia energética previstas en el proyecto merece el calificativo de "instalación sana". Tanto la salud inicial de la instalación como la evolución de este "paciente" se miden por el mantenimiento de cuatro parámetros fundamentales. Adecuada Presión Estática: instalación libre de aire, sin fugas ni rellenados innecesarios, con mínima formación de depósitos de corrosión. Se consigue mediante elementos de presurización, llenado y desgasificación, de buena calidad y adecuadamente dimensionados. Equilibrado y Medición de Caudales en la instalación: todos los terminales y climatizadores reciben en situaciones de máxima demanda los caudales de diseño, con la mínima altura manómetrica de bomba. Gracias a las válvulas de equilibrado se consigue la velocidad de giro óptima de la bomba y el mínimo gasto de energía Buena Autoridad de las válvulas de control gracias a una presión diferencial adecuada y estable. Los caudales siguen en cada instante a la carga térmica, obedeciendo a las necesidades de la instalación, que se traducen en órdenes de apertura y cierre modulantes marcadas por el control de la instalación. Temperaturas de impulsión y retorno adecuadas gracias a la compatibilidad de caudales en los circuitos hidráulicos. Ningún circuito recibe temperaturas diferentes a las de diseño, para mantener el mejor rendimiento de las unidades terminales y las condiciones de temperatura y humedad adecuadas. Un médico diría que temperatura adecuada, presión arterial controlada, buen ritmo cardiaco, en sus límites, adaptado a la actividad del paciente, y un sistema circulatorio libre de obstrucciones definen, a falta de análisis ulteriores, a un paciente saludable. Por tanto, la instalación sana tiene: • Mayor vida útil, con menores averías por depósitos de corrosión, y menor gasto de agua • Proporciona las condiciones de confort aunque las de ocupación del hospital o el clima exterior sean cambiantes. • Reduce al máximo el consumo de energía por bombeo y adapta la producción de agua fría y caliente a las necesidades de cada instante. La ponencia tratará de mostrar las medidas a adoptar y su impacto en el ahorro y el confort térmico de la instalación hospitalaria que las incorpore (AU)

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Cumplimiento de los requisitos de los servicios de urgencias de España: encuesta de autoevaluación / Compliance with the requirements of paediatric emergency departments in Spain: a self-assessment survey

Introducción: La medicina de urgencias pediátrica en España se practica en servicios de distinta configuración. Nuestro objetivo es conocer su situación y adaptación a los requisitos del Cuerpo Doctrinal de la Sociedad Española de Urgencias Pediátricas. Método: Se envió por correo electrónico una encuesta con el cuestionario de Autoevaluación del Cuerpo Doctrinal a los responsables de 47 servicios. Consta de 101 ítems, 69 considerados de cumplimiento obligatorio. Se establecieron 4 grupos de servicios según el cumplimiento de esos 69 ítems: I o situación óptima (cumplen 69); II o que precisan cambios mínimos (cumplen 62-68); III o que precisan cambios mayores (cumplen 41-61); IV o que precisan grandes modificaciones (cumplen menos de 41). Resultados: Contestaron 39 servicios, que atienden una media de 35.310 urgencias anuales (5.000-115.000). Ninguno ha quedado incluido en el grupo I, 6 en el II, 27 en el III y 6 en el IV. Hay una tendencia a un mayor cumplimiento en los servicios más frecuentados, pero sin relación significativa entre el número de urgencias y los ítems cumplimentados. Conclusiones: 1) Muchos servicios de urgencias pediátricos en España tienen problemas estructurales y funcionales que pueden dificultar dar una asistencia de calidad, sin relación significativa con el volumen de urgencias atendidas; 2) los puntos de mejora afectan principalmente a cuestiones funcionales, que deben ser acometidas por sus responsables; 3) un número significativo tienen serios problemas arquitectónicos y de dotación, que precisarían medidas económicas por parte de sus órganos directivos, y 4) nuestro cuestionario de autoevaluación permite identificar acciones de mejora (AU)

Background: Paediatric emergency medicine in Spain is practiced in differently configured departments, staffing and organisation. Our goal was to determine the situation in Paediatric Emergency Departments (PED) and their adaptation to the quality standards proposed by the Spanish Society of Paediatric Emergencies. Method: A self-assessment questionnaire on standards performance was sent to 47 PED directors by e-mail. It consisted of 101 items, 69 considered mandatory. According to the fulfilment of these 69 items 4 PED groups were selected: group I: in the best position (met 69), group II: requiring minimal changes (meeting 62-68), group III: requiring major changes (meeting 41-61); group IV: requiring a lot of major changes (meeting less than 41). Results: Thirty nine questionnaires were completed in full. The PED included in the study tended to an average of 35310 annual emergencies (5000-115000). No PED was included in group I, 6 in II 27 in III and 6 in IV. There was a tendency towards higher compliance with standards in larger PED, but there was no significant relationship between the number of emergencies and the number of items fulfilled. Conclusions: 1. Staffing and architectural and organizational aspects may not be adequate to achieve optimal patient outcome in many PED in Spain. This fact does not appear to be related to the annual patient census. 2. The areas for improvement mainly affect functional issues that must be undertaken by those responsible. 3. A significant number of PED have serious architectural and staffing deficiencies, which would require economic measures by their managers. 4. Our self-assessment questionnaire identifies improvement actions (AU)

Medication administration errors in assisted living: scope, characteristics, and the importance of staff training.

OBJECTIVES: To compare rates of medication errors committed by assisted living staff with different training and to examine characteristics of errors. DESIGN: Observation of medication preparation and passes, chart review, interviews, and questionnaires. SETTING: Stratified random sample of 11 assisted living communities in South Carolina (which permits nonnurses to administer medications) and Tennessee (which does not). PARTICIPANTS: All staff who prepared or passed medications: nurses (one registered nurse and six licensed practical nurses (LPNs)); medication aides (n=10); and others (n=19), including those with more and less training. MEASUREMENTS: Rates of errors related to medication, dose and form, preparation, route, and timing. RESULTS: Medication preparation and administration were observed for 4,957 administrations during 83 passes for 301 residents. The error rate was 42% (20% when omitting timing errors). Of all administrations, 7% were errors with moderate or high potential for harm. The odds of such an error by a medication aide were no more likely than by a LPN, but the odds of one by staff with less training was more than two times as great (odds ratio=2.10, 95% confidence interval=1.27-3.49). A review of state regulations found that 20 states restrict nonnurses to assisting with self-administration of medications. CONCLUSION: Medication aides do not commit more errors than LPNs, but other nonnurses who administered a significant number of medications and assisted with self-administration committed more errors. Consequently, all staff who handle medications should be trained to the level of a medication aide.

La prevención de la legionelosis en los sistemas de riego por aspersión en el medio no urbano / Legionellosis prevention at sprinkler irrigation systems in non-urban environment

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