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.​

Interest Groups and Health Facility Regulation - Future Directions for Health Policy and Systems Research Comment on "What Lies Behind Successful Regulation? A Qualitative Evaluation of Pilot Implementation of Kenya's Health Facility Inspection Reforms".

In their paper, Tama and colleagues observe that one key challenge in a pilot, multi-component intervention to strengthen health facility regulation was the reaction from health facility owners and providers to regulatory processes. In this commentary, we propose that future research and action on health facility regulation in low- and middle-income countries (LMICs) contexts adopt an explicit focus on addressing the role of interests and interest groups in health systems 'hardware' and 'software.' Research on policy processes in LMICs consist of fewer investigations into the political economy of national or sub-national interest groups, such as physician associations or associations of health facility owners. A growing body of literature explores supply-side and demand-side interest groups, power relations within and between these stakeholders, and their advocacy approaches within LMIC health sector policy processes. We posit that such analyses will also help identify facilitators and challenges to implementation and scale-up of similar reforms to health facility regulation.

Maintaining Safety Standards While Building an Urban Alternate Care Facility in a Global Pandemic.

The Philadelphia region responded to the shortage of health care resources imposed by the 2020 COVID-19 pandemic through the creation of the COVID-19 Surge Facility at Temple University's basketball arena. The facility was designed as an acute care medical unit capable of supporting COVID-19 patients who were stable enough to be released from the intensive care unit but not ready for discharge home. Safety was optimized through the application of recommendations from the Joint Commission and Centers for Disease Control and Prevention (CDC). The safety goals include those established by the Joint Commission with regard to patient identification, security, identification of patient safety threats, communication, fire safety, laboratory services, and pharmacologic services. COVID-19-specific goals outlined by the CDC also are addressed and include recommendations for facility layout, managing staff respite and personal protective equipment, patient care areas, supply storage, airflow, and patient hygiene. Although the goal was to meet all of these recommendations, some were not possible due to the austere environment of the arena. However, these shortcomings were met with innovative solutions that provided the next best options. By sharing these experiences, the authors hope to guide future alternate care facilities in their efforts to optimize safety.

From work-integrated learning to virtual case studies: Navigating an alternative to fieldwork in paediatric occupational therapy

Due to Covid-19 regulations, occupational therapy students' access to clinical platforms was restricted and they were unable to perform traditional work integrated learning at approved placements. This situation compelled lecturers to design creative and innovative alternative fieldwork training activities for third-year occupational therapy students in the paediatric domain. In person fieldwork was converted (in part) to six case studies, presented by experts in synchronous online sessions. A structured and systematic approach was implemented to ensure student participation during and after presentations. Students worked in small groups to complete i) a professional reasoning tool and ii) an intervention plan and session to conceptualise and put into writing their selected theoretical approach to each case. One group was given the opportunity to present their work on the case on the day following the case presentation. Continuous formative feedback was provided during the presentation and integration of prior knowledge was encouraged through debate. Assessment focused on metacognition - the students' ability to reflect on their learning during each case. Students experienced the case studies as rich learning opportunities. This approach will be adapted for use in the post-pandemic era to enhance occupational therapy students' learning.

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.

Ifema hospital model. Implementation and start-up of the Pharmacy Department.

On the 20th of March 2020, triggered by the public health emergency declared,  the Health Authorities in Madrid reported a legal instruction (Orden 371/2020)  indicating the organization of a provisional hospital to admit patients with  COVID-19 at the Trade Fair Institution (IFEMA). Several pharmacists working in  the Pharmacy and Medical Devices Department of the Madrid Regional Health  Service were called to manage the Pharmacy Department of the  abovementioned hospital. Required permissions to set up a PD were here  authorized urgently. Tackling human and material resources, and computer  systems for drug purchase and electronic prescription, were some of the initial  issues that hindered the pharmaceutical provision required for patients from the  very day one. Once the purchase was assured, mainly by direct purchase from suppliers, drug dispensing up to 1,250 hospitalized patients (25 nursing units) and 8 ICU patients was taken on. Dispensing was carried out  through either drug stocks in the nursing units or individual patient dispensing  for certain drugs. Moreover, safety issues related to prescription were  considered, and as the electronic prescription was implemented we attained  100% prescriptions review and validation. The constitution of a multidisciplinary  Pharmacy and Therapeutics Committee let agree to a pharmacotherapy guide,  pres cription protocols, therapeutic equivalences, interactions, and drug  dispensing circuits. The Pharmacy Department strategy was to ensure a very  quick response to basic tasks keeping the aim to offer a pharmaceutical care of  the highest quality whenever possible. Working under a health emergency  situation, with many uncertainties and continuous pressure was a plight.  However, the spirit of collaboration in and out of the Pharmacy Department was  aligned with the whole hospital motivation to offer the highest quality of  healthcare. These were possibly the keys to allow caring for almost 4,000  patients during the 42 days that the hospital lasted.

El día 20 de marzo de 2020 la Consejería de Sanidad publicó una Orden  (371/2020) para la apertura de un centro hospitalario provisional para atender a  pacientes COVID-19 en la Institución Ferial de Madrid (IFEMA), por razón de  emergencia sanitaria. Se dispuso un equipo de farmacéuticos de la Subdirección  General de Farmacia y Productos Sanitarios para la apertura de un Servicio de  Farmacia, que obtuvo la autorización correspondiente por el órgano competente, con carácter de urgencia. La gestión de recursos humanos,  materiales y de herramientas informáticas para la adquisición y prescripción  electrónica fueron unas de las primeras dificultades que se solaparon con el  primer reto de garantizar la prestación farmacéutica a los pacientes que atendía  el hospital desde el mismo día uno. Asegurada la adquisición, fundamentalmente  mediante la compra directa a proveedores, se planteó la  dispensación para un máximo de 1.250 pacientes de hospitalización (25  controles de enfermería) y una Unidad de Cuidados Intensivos de 8 pacientes;  se establecieron botiquines en las unidades de enfermería y circuitos  individualizados de dispensación para determinados medicamentos. A su vez,  desde el primer momento se trabajó en la seguridad en la prescripción, llegando  a la revisión y validación del 100% de los tratamientos, una vez instaurada la  prescripción electrónica. La creación de una  Comisión de Farmacia y Terapéutica multidisciplinar permitió consensuar la guía farmacoterapéutica, protocolos de  prescripción, equivalencias terapéuticas, interacciones y circuitos de  dispensación de medicamentos. La estrategia del Servicio de Farmacia se basó  en asegurar una respuesta rápida en las funciones básicas, sin perder la visión  de incorporar una atención farmacéutica de la máxima calidad posible a medida  que iba siendo factible. A pesar de un escenario adverso, de incertidumbre y  presión continuas por la emergencia sanitaria, se ha mantenido un espíritu de  colaboración y contribución dentro y fuera del Servicio de Farmacia, alineado con un objetivo común de trabajo en equipo para brindar una atención sanitaria rápida y de la mayor calidad posible. Posiblemente éstas han sido las claves del  éxito que han permitido atender a casi 4.000 pacientes en los 42 días de vida  del hospital.

Health and Safety in a Family Child Care Network: An Analysis of Violation Data of Routine, Full Unannounced Inspections.

OBJECTIVE: To analyze how engagement with a staffed family child network is associated with compliance on health and safety regulations among family day care (FDC) homes. METHODS: Publically available data on health and safety inspection violations on FDC homes were merged with engagement data from a staffed family child network. Descriptive analysis, logistic regression, and latent class analysis were used. RESULTS: Network FDC homes, compared to non-network FDC homes, were less likely to have health and safety violations in the areas of Child/Family/Staff Documentation (43.1% vs. 53.6%, p = 0.001) and Indoor Safety (36.0% vs. 42.6%, p = .041). Controlling for area median income and for decades since obtaining license, network FDC homes had fewer violations, fewer violation categories, and less variety of violation categories. Additionally, FDC homes which were not engaged with the staffed family child network but were in the city or town in which the network offered services, performed better compared to FDC homes in cities or towns without network resources. CONCLUSIONS FOR PRACTICE: The better compliance among network FDC homes and among FDC homes in cities and towns where the network offers services, suggests that the network is having positive effects on health and safety quality in FDC homes. A staffed child care network may be a means to improve child care quality and may be a means of improving educational and health outcomes for children.

Regulating digital health.

Realizing the potential of digital health requires overcoming its inherent risks. Gary Humphreys reports.

Tze-Yun Leong: the need for intelligent regulation.

Tze-Yun Leong talks to Gary Humphreys about the challenges faced in realizing the potential of digital health.

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).

The Distribution of Regulation in Aged and Dementia Care: A Continuum Approach.

The regulation of care services has become the principal means by which the state influences provision. In this article we examine the regulation of dementia care within organizations to show how some care activities attract more regulation than others. While often perceived to be overwhelming, regulation is in fact unevenly distributed at the system, organization and, in particular, the care practice levels. In practice, some areas of care are heavily regulated, while others are less so. Drawing on research interviews with staff (N = 60) at three levels of care provider organizations-senior managers, facility managers, and direct care workers-a continuum of regulation, with regulations collecting around some care activities and not others, is developed. This is used to plot how different care activities are affected by regulation. Understanding how regulations collect around some activities and not others shows where flexibility and innovation in care are possible. This has implications for the discretion care workers can exercise in daily care, effective organizational strategies for managing care and regulation, and regulatory policy. Current debates around regulation should shift from notions of good/bad and more/less regulation to an analysis of how regulation creates areas that are closely controlled and those that allow practice innovation.

Modelo hospital de IFEMA. Implantación y puesta en marcha de su Servicio de Farmacia / Ifema hospital model. Implementation and start-up of the Pharmacy Department

El día 20 de marzo de 2020 la Consejería de Sanidad publicó una Orden (371/2020) para la apertura de un centro hospitalario provisional para atender a pacientes COVID-19 en la Institución Ferial de Madrid (IFEMA), por razón de emergencia sanitaria. Se dispuso un equipo de farmacéuticos de la Subdirección General de Farmacia y Productos Sanitarios para la apertura de un Servicio de Farmacia, que obtuvo la autorización correspondiente por el órgano competente, con carácter de urgencia. La gestión de recursos humanos, materiales y de herramientas informáticas para la adquisición y prescripción electrónica fueron unas de las primeras dificultades que se solaparon con el primer reto de garantizar la prestación farmacéutica a los pacientes que atendía el hospital desde el mismo día uno. Asegurada la adquisición, fundamentalmente mediante la compra directa a proveedores, se planteó la dispensación para un máximo de 1.250 pacientes de hospitalización (25 controles de enfermería) y una Unidad de Cuidados Intensivos de 8 pacientes; se establecieron botiquines en las unidades de enfermería y circuitos individualizados de dispensación para determinados medicamentos. A su vez, desde el primer momento se trabajó en la seguridad en la prescripción, llegando a la revisión y validación del 100% de los tratamientos, una vez instaurada la prescripción electrónica. La creación de una omisión de Farmacia y Terapéutica multidisciplinar permitió consensuar la guía farmacoterapéutica, protocolos de prescripción, equivalencias terapéuticas, interacciones y circuitos de dispensación de medicamentos. La estrategia del Servicio de Farmacia se basó en asegurar una res-puesta rápida en las funciones básicas, sin perder la visión de incorporar una atención farmacéutica de la máxima calidad posible a medida que iba siendo factible. A pesar de un escenario adverso, de incertidumbre y presión continuas por la emergencia sanitaria, se ha mantenido un espíritu de colaboración y contribución dentro y fuera del Servicio de Farmacia, alineado con un objetivo común de trabajo en equipo para brindar una atención sanitaria rápida y de la mayor calidad posible. Posiblemente éstas han sido las claves del éxito que han permitido atender a casi 4.000 pacientes en los 42 días de vida del hospital

On the 20th of March 2020, triggered by the public health emergency declared, the Health Authorities in Madrid reported a legal instruction (Orden 371/2020) indicating the organization of a provisional hospital to admit patients with COVID-19 at the Trade Fair Institution (IFEMA).Several pharmacists working in the Pharmacy and Medical Devices Department of the Madrid Regional Health Service were called to manage the Pharmacy Department of the abovementioned hospital. Required permissions to set up a PD were here authorized urgently. Tackling human and material resources, and computer systems for drug purchase and electronic prescription, were some of the initial issues that hindered the pharmaceutical provision required for patients from the very day one. Once the purchase was assured, mainly by direct purchase from suppliers, drug dispensing up to 1,250 hospitalized patients (25 nursing units) and 8 ICU patients was taken on. Dispensing was carried out through either drug stocks in the nursing units or individual patient dispensing for certain drugs. Moreover, safety issues related to prescription were considered, and as the electronic prescription was implemented we attained 100% prescriptions review and validation. The constitution of a multidisciplinary Pharmacy and Therapeutics Committee let agree to a pharmacotherapy guide, prescription protocols, therapeutic equivalences, interactions, and drug dispensing circuits. The Pharmacy Department strategy was to ensure a very quick response to basic tasks keeping the aim to offer a pharmaceutical care of the highest quality whenever possible. Working under a health emergency situation, with many uncertainties and continuous pressure was a plight. However, the spirit of collaboration in and out of the Pharmacy Department was aligned with the whole hospital motivation to offer the highest quality of healthcare. These were possibly the keys to allow caring for almost 4,000 patients during the 42 days that the hospital lasted

An empirical study of how the Dutch healthcare regulator first formulates the concept of trust and then puts it into practice.

BACKGROUND: Responsive regulation assumes that the parties being regulated are trustworthy and motivated by social responsibility. This assumes that regulation based upon trust will improve the regulated organization more effectively than other regulation models. The purpose of our qualitative study was to unravel the most important elements of trust in the inspectee which can support the inspector's work and to develop a model and a framework of trust that can be used by the inspectors to legitimize their trust in the inspectee. METHODS: We conducted an empirical study on trust regarding the regulation of care services to reveal how trust in the inspectee is conceptualized and assessed. Based on literature and empirical research, we synthesized the concept of trust into six elements, five regarding behavior, and a sixth looking at information about its context. We developed a practical framework for the concept to reduce the conceptual ambiguity, strengthen regulatory assessment, and support appropriate tailoring of the regulatory response. RESULTS: Six elements with respect to trust emerged from the data: showing integrity; transparency; ability to learn; accepting feedback; showing actual change in behavior; context information. These five behavioral elements, plus the context information were merged into a Framework of Trust and designed into an interactive PDF document. CONCLUSIONS: This study has sought to address a gap in the empirical knowledge regarding the assessment of trust in the inspectee. The results aim to inform and clarify the regulatory conceptualization and understanding of trust in the inspectee. Other inspectorates may learn from these results for their own practice and explore whether operational deployment of our Framework of Trust effects their assessment and enforcement strategies.

Hospital-Acquired Condition Reduction Program Is Not Associated With Additional Patient Safety Improvement.

In 2013 the Centers for Medicare and Medicaid Services announced that it would begin levying penalties against hospitals with the highest rates of hospital-acquired conditions through the Hospital-Acquired Condition Reduction Program. Whether the program has been successful in improving patient safety has not been independently evaluated. We used clinical registry data on rates of hospital-acquired conditions in 2010-18 from a large surgical collaborative in Michigan to estimate the impact of the policy. While rates of all such conditions declined from 133.4 per 1,000 discharges in the pre-program period to 122.2 in the post-program period, greater improvements were observed for nontargeted measures. We conclude that the program did not improve patient safety in Michigan beyond existing trends. These findings raise questions about whether the program will lead to improvements in patient safety as intended.

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.