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.

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

EMTALA (Emergency Medical Treatment and Active Labor Act) Obligations: A Case Report and Review of the Literature.

BACKGROUND: The Emergency Medical Treatment and Active Labor Act (EMTALA) was enacted in 1986 in the United States to address "patient dumping," or refusing to provide emergency care to patients and instead transferring them to other hospitals. Under EMTALA, the "reverse-dumping" provision prevents hospitals from refusing patients who require specialized capabilities or facilities if the hospital has the capacity to treat them. Despite this provision, patients continue to be transferred to distant tertiary care centers. METHODS: We reviewed the literature on EMTALA in the context of a critically ill woman with an infection associated with an orthopaedic implant who was rejected from 2 geographically closer tertiary care centers and was ultimately transferred by helicopter ambulance to an academic teaching hospital that was 169 miles away from her home. RESULTS: After transfer to our tertiary care, level-I trauma center, the patient spent 61 days in the intensive care unit; she required 9 operative procedures, which totaled 1,520 minutes of operative time. Eighteen medical specialties and 8 ancillary medical consulting teams were involved in her care. She underwent 1,436 laboratory and 83 radiographic studies. The total reimbursement from Medi-Cal (California's Medicaid program) for her care in our tertiary care center was $463,753; the hospital charges were more than tenfold higher. CONCLUSIONS: Dumping and reverse dumping continue despite compromise of patient care and the high financial burden of the accepting institutions. This may be due to ineffective monitoring and enforcement, lack of uniformity among the courts, and lack of incentive to receive uninsured or poorly funded patients. Under EMTALA, it is difficult for tertiary care centers to argue lack of specialized capabilities or capacity to accept patients, and neither hospitals nor physicians are compensated for the charges of providing care to uninsured or underinsured patients. Moving forward, efforts to better align financial incentives through cost-sharing between community hospitals and tertiary care centers, increased clinician literacy regarding the provisions of EMTALA, and increased transparency with hospital transfers may help improve EMTALA compliance and patient care.

Overseeing health care facilities in Shanghai, China: regulatory regime, activities and challenges of the governmental regulatory system.

BACKGROUND: Government regulation has played a crucial role in ensuring the quality, safety and equity of health care. However, few empirical studies have investigated Chinese governmental oversight of health care facilities in terms of regulatory arrangements and approaches. This study aims to explore the regulatory regime and main activities within the health sector in Shanghai, a city featuring abundant health care resources and a complex medical system, to provide policy implications for better regulation and offer valuable reference for elsewhere in China and other developing countries. METHODS: We explored the structure and main activities of government regulation over health care facilities in Shanghai, compared it with the regulatory system in Hong Kong and Taipei through a literature review and analyzed the data on regulatory activities conducted by the local Health Supervision Agencies using descriptive statistical analysis. The data were collected from the Shanghai Statistical Yearbook 2014-2018 and the centralized data bank of the Shanghai Health Supervision Authority. RESULTS: Shanghai has established a unique governmental regulatory system compared to Hong Kong and Taipei. We found health care facilities in Shanghai underwent less frequent inspections between 2013 and 2017, as average annual inspections at individual facilities decreased from 3.8 to 2.7. The number of annual administrative penalties and notifications issued for accumulating points on local health care facilities' violations decreased by 24.8 and 40.7%, respectively, and complaints against health care facilities decreased by 29.1% during the study period. CONCLUSIONS: The local governmental regulatory system played a vital role in overseeing the health care facilities and ensuring their legal compliance by exerting the various regulatory activities. Both annual administrative penalties and notifications of accumulating points on local health care facilities' violations decreased considerably, with complaints against health care facilities reducing. As our study identified significant challenges, including regulatory fragmentation and no risk-based approach used, we offer recommendations to develop new policies and establish new mechanisms for better regulation.

A systematic review of compliance with indoor tanning legislation.

BACKGROUND: Many jurisdictions have enacted indoor tanning legislation in response to the health risks of artificial ultraviolet (UV) radiation exposure. Key components of these legislations include banning minors' access, requiring parental consent or accompaniment, providing protective eyewear, posting health warning signs, and communicating important health risk information. However, legislation must be complied with to be impactful. Evidence around compliance with indoor tanning legislations has not been synthesized and is an important step toward determining changes in practice due to legislation. METHODS: A systematic review was conducted to obtain peer-reviewed literature about compliance with indoor tanning legislation worldwide. Six databases were searched, resulting in 12,398 citations. Sixteen studies met the inclusion criteria (peer-reviewed scientific studies, published in English, focused primarily on compliance with indoor tanning legislations, and focused on commercial indoor tanning in indoor tanning facilities). RESULTS: Compliance with most aspects of indoor tanning legislation varied widely. There was good compliance for provision of protective eyewear (84 to 100%; mean = 92%; SD = 8). Compliance with age restrictions ranged from 0 to 100% (mean = 65%; SD = 25), while compliance with posting warning labels in the required locations within a tanning facility ranged from 8 to 72% (mean = 44%; SD = 27). Variation in compliance may be due to true differences, study methodology, or temporal trends. CONCLUSIONS: Variability in compliance with indoor tanning legislation, as found in this systematic review, indicates the legislations may not be having their intended protective effects on the public's health. The reasons for such low and varied compliance with certain aspects of legislation, and high compliance with other aspects of legislation, deserve further attention in future research to inform best practices around ensuring high and consistent compliance with indoor tanning legislations worldwide.

State Licensing Regulations on Screen Time in Childcare Centers: An Impetus for Participatory Action Research.

BACKGROUND: New licensing regulations require Louisiana early care and education centers (ECEs) to limit children's screen time and increase physical activity. A community- academic partnership involving academic, community, government, and ECE stakeholders launched two initiatives: (1) an evaluation of the implementation of licensing regulations at the local level and (2) a statewide effort to develop technical assistance for ECE directors. OBJECTIVES: To describe the methods and lessons learned and to establish recommendations based on this ongoing participatory action research. METHODS: A case study approach was used to identify the lessons learned and recommendations thus far, based on partners' perspectives and ECE directors' participation. LESSONS LEARNED: Recommendations include to share power and funding among stakeholders, to engage directors as partners to overcome recruitment challenges, and to start with the end in mind to ensure meaningful community engagement. CONCLUSIONS: This participatory action approach is leading to innovative, feasible strategies to increase children's physical activity.

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.

Affordable Care Act Impact on Community Health Center Staffing and Enrollment: A Cross-Sectional Study.

Over 500 000 Washingtonians gained health insurance under the Affordable Care Act (ACA). As more patients gain insurance, community health centers (CHCs) expect to see an increase in demand for their services. This article studies the CHCs in Washington State to examine how the increase in patients has been impacting their workload and staffing. We found a reported mean increase of 11.7% and 5.4% in new Medicaid and Exchange patients, respectively. Half of the CHCs experienced large or dramatic workload impact from the ACA. Our findings suggest that CHCs need further workforce support to meet the expanding patient demand.

Universal Design as a Booster for Housing Quality and Architectural Practice.

Norwegian central government has for the last decade increasingly focused on universal design. Fundamental changes in the Norwegian building code and corresponding regulations in 2010 give an apparently clear framework for the implementation of accessibility and universal design. However, it seems that neither increased awareness of accessibility requirements and universal design, nor compliance with the building code guarantees improvement of housing quality and usability. The Norwegian regulations have gone further in the direction of performance requirements than most other countries. This applies to all types of requirements, including requirements for usability, functionality and accessibility. Hardly any specifications are to be found in the regulations. Ideally, this lack of specifications should give designers the opportunity to develop innovative answers and hence to respond to different contexts and needs. Still, many architects and builders ask for clear specifications, in order to simplify and speed up design processes and make control of solutions easier. Many architects understand guidelines as minimum requirements, and are thus reproducing the identical solutions without considering the context and the needs of the users. They see accessibility as another regulatory pressure and requirements as restrictions rather than positive incentives. However, there are examples of designers who have internalised the regulatory framework and thus are able to create and integrate inclusive design in their daily work. Based on recent research conducted by SINTEF Building and Infrastructure and financed by the Norwegian State Housing Bank, this paper presents examples of practice where dwellings have been developed within a framework of universal design. Focus of the research has been on the approach of the design team and their understanding and use of the regulatory framework in order to create better homes in dialogue with the building authorities. Main objectives are to: - Contribute to better understanding of universal design as a tool and a method to improve housing quality and usability - Investigate the conditions for developing dwellings with innovative and functional solutions in compliance with the building code - Discuss challenges in interpreting the requirements and in taking the needs of various resident groups into account.

Medicare and Medicaid Programs; Fire Safety Requirements for Certain Health Care Facilities. Final rule.

This final rule will amend the fire safety standards for Medicare and Medicaid participating hospitals, critical access hospitals (CAHs), long-term care facilities, intermediate care facilities for individuals with intellectual disabilities (ICF-IID), ambulatory surgery centers (ASCs), hospices which provide inpatient services, religious non-medical health care institutions (RNHCIs), and programs of all-inclusive care for the elderly (PACE) facilities. Further, this final rule will adopt the 2012 edition of the Life Safety Code (LSC) and eliminate references in our regulations to all earlier editions of the Life Safety Code. It will also adopt the 2012 edition of the Health Care Facilities Code, with some exceptions.

Quantifying Syringe Exchange Program Operational Space in the District of Columbia.

Syringe exchange programs (SEPs) are effective structural interventions for HIV prevention among persons who inject drugs. In 2000, a buffer zone policy (the 1000 Foot Rule) was implemented in Washington, DC, that prohibited SEP operations within 1000 feet of schools. We examined changes in the amount of legal SEP operational space over time. We used data pertaining to school operations and their approximate physical property boundaries to quantify the impact of the 1000 Foot Rule on legal SEP operational space from its implementation in 2000-2013. Adherence to the 1000 Foot Rule reduced SEP operational space by more than 50 % annually since its implementation. These findings demonstrate the significant restrictions on the amount of legal SEP operational space in Washington, DC, that are imposed by the 1000 Foot Rule. Changing this policy could have a significant impact on SEP service delivery among injectors.

Health and Safety in Family Day Care Homes: Association Between Regulatory Non-compliance and Lower Median Income.

OBJECTIVES: To determine frequency of non-compliance with child care regulations among family day care homes (FDCH) and identify the role of income in compliance. METHODS: We analyzed non-compliance in 746 routine, unannounced inspection and re-inspection reports of FDCH collected by the Connecticut Department of Public Health licensing specialists in 2007-2008 and linked results to median income of zip code data. We grouped the 83 state regulations into 12 regulation categories, analyzed 11 categories, and used latent class analysis to classify each FDCH as high or low compliance for each category. We used logistic regression analysis to estimate the odds ratios of low compliance. RESULTS: Among the 746 FDCH inspections (594 first inspections and 152 re-inspections), we found high rates of non-compliance in inspection regulations in immunizations (32.9 %), water temperature (35.6 %) and hazards (30.0 %). Among the 11 regulation categories, 4 categories (indoor safety, emergency preparedness, child/family/staff documentation, and qualifications of provider) had regulations with high non-compliance. Median household income of FDCH zip code was lower for re-inspection sites than for inspection sites ($34,715 vs. $57,118, p < 0.0001) and FDCH in the lowest quartile of income had greater odds of low compliance in indoor safety (OR 1.86, 95 % CI 1.04, 3.35, p < 0.05). CONCLUSIONS: The majority of FDCH were in compliance with the majority of regulations, yet there are glaring non-compliance issues in inspections and re-inspections and there are income-based inequities that place children at higher risk who are already at high risk for suboptimal health outcomes.