Análisis de fallos y efectos en la preparación y dispensación de quimioterápicos / Failure mode and effect analysis in the preparation and dispensation of chemotherapy / Análise de falhas e efeitos na preparação e dispensação de quimioterápicos

OBJETIVO: Realizar un Análisis Multimodal de fallas y efectos para identificar prospectivamente los riesgos relacionados a la fase de la preparación y dispensación de medicamentos quimioterápicos en una unidad ambulatoria de un centro de referencia en oncología. MÉTODOS: Se utilizaron las seis primeras etapas del Análisis Multimodal de fallas y Efectos: identificar las situaciones peligrosas y montar un equipo; definir el proceso a ser analizado describiendo gráficamente; aplicar lluvia de ideas buscando identificar modos de fallas; priorizar los modos de fallas y realizar análisis de riesgos; identificar las causas potenciales de los modos de fallo y volver a dibujar el proceso. RESULTADOS: Se identificaron diecisiete modos de falla, siendo dos clasificados como de alto riesgo: cambiar la ventana de salida del medicamento y cálculo erróneo de la dosis de medicamento intratecal. CONCLUSIONES: Se identificaron los posibles modos de falla que se relacionaban al proceso analizado, además, fue posible definir causas potenciales para la existencia de esos riesgos

AIM: Conduct a Failure Mode and Effect Analysis (FMEA) to prospectively identify the risks related to the preparation and dispensation of chemotherapy drugs at an outpatient unit of a reference center in oncology. METHODS: The first six stages of Failure Mode and Effect Analysis were used to identify dangerous situations and assemble a team; define the process to be analyzed and describe it graphically; apply a host of ideas to identify failure modes; prioritize failure modes and conduct risk analysis; identify potential causes of failure modes and redesign the process. RESULTS: Seventeen failure modes were identified, two of which were classified as high risk: changing the output window for the drug and miscalculating the intrathecal drug dose. CONCLUSIONS: The possible failure modes related to the process analyzed were identified; in addition, it was possible to define potential causes of these risks

OBJETIVO: Realizar uma Análise Multimodal de Falhas e Efeitos para identificar prospectivamente os riscos relacionados à fase do preparo e dispensação de medicamentos quimioterápicos em uma unidade ambulatorial de um centro de referência em oncologia. MÉTODOS: Foram utilizadas as seis primeiras etapas da Análise Multimodal de Falhas e Efeitos: identificar as situações perigosas e montar uma equipe; definir o processo a ser analisado descrevendo graficamente; aplicar chuva de ideias buscando identificar modos de falhas; priorizar os modos de falhas e realizar análise dos riscos; identificar causas potenciais dos modos de falha e redesenhar o processo. RESULTADOS: Foram identificados dezessete modos de falha, sendo dois classificados como de alto risco: trocar a janela de saída do medicamento e cálculo errado da dose de medicamento intratecal. CONCLUSÕES: Foram identificados os possíveis modos de falha que se relacionavam ao processo analisado, além disso, foi possível definir causas potenciais para a existência desses riscos

Using the WHO International Classification of patient safety framework to identify incident characteristics and contributing factors for medical or surgical complication deaths.

This study aimed to operationalise and use the World Health Organisation's International Classification for Patient Safety (ICPS) to identify incident characteristics and contributing factors of deaths involving complications of medical or surgical care in Australia. A sample of 500 coronial findings related to patient deaths following complications of surgical or medical care in Australia were reviewed using a modified-ICPS (mICPS). Over two-thirds (69.0%) of incidents occurred during treatment and 27.4% occurred in the operating theatre. Clinical process and procedures (55.9%), medication/IV fluids (11.2%) and healthcare-associated infection/complications (10.4%) were the most common incident types. Coroners made recommendations in 44.0% of deaths and organisations undertook preventive actions in 40.0% of deaths. This study demonstrated that the ICPS was able to be modified for practical use as a human factors taxonomy to identify sequences of incident types and contributing factors for patient deaths. Further testing of the mICPS is warranted.

Standardising the Classification of Harm Associated with Medication Errors: The Harm Associated with Medication Error Classification (HAMEC).

Classifying harm associated with a medication error can be time consuming and labour intensive and limited studies undertake this step. There is no standardised process, and few studies that report harm assessment provide adequate methods to allow for study replication. Studies typically mention that a clinical review panel classified patient harm and provide a reference to a classification tool. Moreover, in many studies it is unclear whether potential or actual harm was classified as studies refer only to 'error severity'. The tools used to categorise the severity of patient harm vary widely across studies and few have been assessed for inter-rater reliability and criterion validity. In this paper, we describe the systematic process we undertook to synthesise the defining elements and strengths, while mitigating the limitations, of existing harm classification tools to derive the Harm Associated with Medication Error Classification (HAMEC). This new tool provides a harm classification for use across clinical and research settings. The provision of an explicit process for its application and guiding category descriptors are designed to reduce the risk of misclassification and produce results that are comparable across studies. As the World Health Organisation embarks on its international safety challenge of reducing medication-related harm by 50%, accompanying methodological advances are required to measure progress.

Agency for Healthcare Research and Quality Evidence-based Practice Center methods provide guidance on prioritization and selection of harms in systematic reviews.

OBJECTIVES: Systematic reviews should provide balanced assessments of benefits and harms, while focusing on the most important outcomes. Selection of harms to be reviewed can be a challenge due to the potential for large numbers of diverse harms. STUDY DESIGN AND SETTING: A workgroup of methodologists from Evidence-based Practice Centers (EPCs) developed consensus-based guidance on selection and prioritization of harms in systematic reviews. Recommendations were informed by a literature scan, review of Evidence-based Practice Center reports, and interviews with experts in conducting reviews or assessing harms and persons representing organizations that commission or use systematic reviews. RESULTS: Ten recommendations were developed on selection and prioritization of harms, including routinely focusing on serious as well as less serious but frequent or bothersome harms; routinely engaging stakeholders and using literature searches and other data sources to identify important harms; using a prioritization process (formal or less formal) to inform selection decisions; and describing the methods used to select and prioritize harms. CONCLUSION: We provide preliminary guidance for a more structured approach to selection and prioritization of harms in systematic reviews.

Uso inadecuado de términos vasculares: mitos y leyendas / Inadequate use of vascular ends: Challenges and legends

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Technical rationality and the decentring of patients and care delivery: A critique of 'unavoidable' in the context of patient harm.

In recent decades, debate on the quality and safety of healthcare has been dominated by a measure and manage administrative rationality. More recently, this rationality has been overlaid by ideas from human factors, ergonomics and systems engineering. Little critical attention has been given in the nursing literature to how risk of harm is understood and actioned, or how patients can be subjectified and marginalised through these discourses. The problem of assuring safety for particular patient groups, and the dominance of technical forms of rationality, has seen the word 'unavoidable' used in connection with intractable forms of patient harm. Employing pressure injury policy as an exemplar, and critically reviewing notions of risk and unavoidable harm, we problematise the concept of unavoidable patient harm, highlighting how this dominant safety rationality risks perverse and taken-for-granted assumptions about patients, care processes and the nature of risk and harm. In this orthodoxy, those who specify or measure risk are positioned as having more insight into the nature of risk, compared to those who simply experience risk. Driven almost exclusively as a technical and administrative pursuit, the patient safety agenda risks decentring the focus from patients and patient care.

Analyisis of the adverse events reported to the office of the clinical director at a dental school in Bogota, Colombia / Análisis de los events adversos reportados a direcciónde clínicas en una facultad de odontología de Bogotá-Colombia

Dentistry is interested in identifying and controlling adverseevents, understood as involuntary injuries to the patient duringdental care. The aim of this study was to analyze the adverse eventsreported to the Office of the Clinical Director at the School ofDentistry at Pontificia Universidad Javeriana (Colombia) during2011­2012. It was an observational, descriptive study thatevaluated 227 dental clinical records of patients who filed acomplaint with the Office of the Clinical Director. Of these, 43were adverse events and were used as the basis for this study. Ofthe 16,060 patients who received care during 2011 ­ 2012, 0.26%(43) filed a complaint involving an adverse event, of which 97.7 %were considered preventable. Most of these (76.18%, n= 32)occurred during clinical management of treatments in differentspecialties, 9.5% (4) were the result of deficient external dentallaboratory quality, and 14.32% (6) were due to failure in documentmanagement, soft tissue injury, misdiagnosis and swallowingforeign objects. Of the patients involved, 65.2% (28) received carefrom postgraduate students, with the highest number of cases inthe Oral Rehabilitation speciality. The occurrence of adverseevents during dental care, indicates the need for information abouttheir origin in order to establish protection barriers and preventtheir incidence, particularly in the educational area under thestudent dental clinic service model.

En odontología existe interés por identificar y controlar loseventos adversos, entendidos como las lesiones no voluntarias que ocurren durante la atención odontológica. El objetivo de este estudio fue analizar los eventos adversos reportados a Dirección de Clínicas de la Facultad de Odontología de la Pontificia Universidad Javeriana durante el periodo 2011­2012.Se realizó un estudio observacional descriptivo para el que se evaluaron 227 historias clínicas de pacientes que reportar onuna queja a la Dirección de Clínicas, de las cuales en 43 se evidenció la presencia de eventos adversos, a partir de las cualesse registró la información analizada en este estudio. De los16.060 pacientes atendidos durante el periodo 2011 y 2012, el0,26% (43) formularon alguna queja que resultó en un evento adverso, de los cuales el 97,7 % se consideraron prevenibles. Elmayor porcentaje 76,18 % (32) se presentó durante la gestión clínica de tratamientos en diferentes áreas. El 9,5 % (4), sedebieron a fallas en la calidad del trabajo del laboratorio externo; el 14,32% (6) correspondió a eventos generados porfallas en la gestión documental, lesiones de tejidos blandos, fallas de diagnóstico y deglución de objetos extraños. El 65,2 %(28) de los pacientes fueron atendidos por estudiantes de posgrado, con el mayor número de casos en la especialidad de Rehabilitación Oral. La presentación de eventos adversos durante el proceso de atención en odontología, es indicador dela necesidad de conocer su origen para establecer barreras deprotección y prevenir su incidencia, especialmente en el área formativa bajo el modelo de atención docencia servicio.

Accidentes más comunes en las Unidades de Cuidados Intensivos Pediátricos (UCIP) / Most common accidents in the Pediatric Intensive Care Units (PICU)

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An analysis of dental patient safety incidents in a patient complaint and healthcare supervisory database in Finland.

OBJECTIVE: Few studies of patient harm and harm-prevention methods in dentistry exist. This study aimed to identify and characterize dental patient safety incidents (PSIs) in a national sample of closed dental cases reported to the Regional State Administrative Agencies (AVIs) and the National Supervisory Authority for Welfare and Health (Valvira) in Finland. MATERIALS AND METHODS: The sample included all available fully resolved dental cases (n = 948) during 2000-2012 (initiated by the end of 2011). Cases included both patient and next of kin complaints and notifications from other authorities, employers, pharmacies, etc. The cases analyzed concerned both public and private dentistry and included incident reports lodged against dentists and other dental-care professionals. Data also include the most severe cases since these are reported to Valvira. PSIs were categorized according to common incident types and preventability and severity assessments were based on expert opinions in the decisions from closed cases. RESULTS: Most alleged PSIs were proven valid and evaluated as potentially preventable. PSIs were most often related to different dental treatment procedures or diagnostics. More than half of all PSIs were assessed as severe, posing severe risk or as causing permanent or long-lasting harm to patients. The risk for PSI was highest among male general dental practitioners with recurring complaints and notifications. CONCLUSIONS: Despite some limitations, this register-based study identifies new perspectives on improving safety in dental care. Many PSIs could be prevented through the proper and more systematic use of already available error-prevention methods.

What are incident reports telling us? A comparative study at two Australian hospitals of medication errors identified at audit, detected by staff and reported to an incident system.

OBJECTIVES: To (i) compare medication errors identified at audit and observation with medication incident reports; (ii) identify differences between two hospitals in incident report frequency and medication error rates; (iii) identify prescribing error detection rates by staff. DESIGN: Audit of 3291 patient records at two hospitals to identify prescribing errors and evidence of their detection by staff. Medication administration errors were identified from a direct observational study of 180 nurses administering 7451 medications. Severity of errors was classified. Those likely to lead to patient harm were categorized as 'clinically important'. SETTING: Two major academic teaching hospitals in Sydney, Australia. MAIN OUTCOME MEASURES: Rates of medication errors identified from audit and from direct observation were compared with reported medication incident reports. RESULTS: A total of 12 567 prescribing errors were identified at audit. Of these 1.2/1000 errors (95% CI: 0.6-1.8) had incident reports. Clinically important prescribing errors (n = 539) were detected by staff at a rate of 218.9/1000 (95% CI: 184.0-253.8), but only 13.0/1000 (95% CI: 3.4-22.5) were reported. 78.1% (n = 421) of clinically important prescribing errors were not detected. A total of 2043 drug administrations (27.4%; 95% CI: 26.4-28.4%) contained ≥ 1 errors; none had an incident report. Hospital A had a higher frequency of incident reports than Hospital B, but a lower rate of errors at audit. CONCLUSIONS: Prescribing errors with the potential to cause harm frequently go undetected. Reported incidents do not reflect the profile of medication errors which occur in hospitals or the underlying rates. This demonstrates the inaccuracy of using incident frequency to compare patient risk or quality performance within or across hospitals. New approaches including data mining of electronic clinical information systems are required to support more effective medication error detection and mitigation.

Proyecto IDEA: Identificación de efectos adversos / No disponible

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