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Evaluating inputs of failure modes and effects analysis in identifying patient safety risks.

ABSTRACT: PURPOSE:There is a growing awareness on the use of systems approaches to improve patient safety and quality. While earlier studies evaluated the validity of such approaches to identify and mitigate patient safety risks, so far only little attention has been given to their inputs, such as structured brainstorming and use of system mapping approaches (SMAs), to understand their impact in the risk identification process. To address this gap, the purpose of this paper is to evaluate the inputs of a well-known systems approach, failure modes and effects analysis (FMEA), in identifying patient safety risks in a real healthcare setting. DESIGN/METHODOLOGY/APPROACH:This study was conducted in a newly established adult attention deficit hyperactivity disorder service at Cambridge and Peterborough Foundation Trust in the UK. Three stakeholders of the chosen service together with the facilitators conducted an FMEA exercise along with a particular system diagram that was initially found as the most useful SMA by eight stakeholders of the service. FINDINGS:In this study, it was found that the formal structure of FMEA adds value to the risk identification process through comprehensive system coverage with the help of the system diagram. However, results also indicates that the structured brainstorming refrains FMEA participants from identifying and imagining new risks since they follow the process predefined in the given system diagram. ORIGINALITY/VALUE:While this study shows the potential contribution of FMEA inputs, it also suggests that healthcare organisations should not depend solely on FMEA results when identifying patient safety risks; and therefore prioritising their safety concerns.

SUBMITTER: Simsekler MCE

PROVIDER: S-EPMC6420048 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature

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Evaluating inputs of failure modes and effects analysis in identifying patient safety risks.

Simsekler Mecit Can Emre MCE Kaya Gulsum Kubra GK Ward James R JR Clarkson P John PJ

International journal of health care quality assurance 20190201 1

<h4>Purpose</h4>There is a growing awareness on the use of systems approaches to improve patient safety and quality. While earlier studies evaluated the validity of such approaches to identify and mitigate patient safety risks, so far only little attention has been given to their inputs, such as structured brainstorming and use of system mapping approaches (SMAs), to understand their impact in the risk identification process. To address this gap, the purpose of this paper is to evaluate the inpu ...[more]

PMID: 30859865

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Project description:ObjectivesMany guidelines and regulations allow children and adolescents to be enrolled in research without the prospect of clinical benefit when it poses minimal risk. However, few systematic methods exist to determine when research risks are minimal. This situation has led to significant variation in minimal risk judgments, raising concern that some children are not being adequately protected. To address this concern, we describe a new method for implementing the widely endorsed "risks of daily life" standard for minimal risk. This standard defines research risks as minimal when they do not exceed the risks posed by daily life activities or routine examinations.MethodsThis study employed a conceptual and normative analysis, and use of an illustrative example.ResultsDifferent risks are composed of the same basic elements: Type, likelihood, and magnitude of harm. Hence, one can compare the risks of research and the risks of daily life by comparing the respective basic elements with each other. We use this insight to develop a systematic method, direct comparative analysis, for implementing the "risks of daily life" standard for minimal risk. The method offers a way of evaluating research procedures that pose the same types of risk as daily life activities, such as the risk of experiencing anxiety, stress, or other psychological harm. We thus illustrate how direct comparative analysis can be applied in practice by using it to evaluate whether the anxiety induced by a respiratory CO2 challenge poses minimal or greater than minimal risks in children and adolescents.ConclusionsDirect comparative analysis is a systematic method for applying the "risks of daily life" standard for minimal risk to research procedures that pose the same types of risk as daily life activities. It thereby offers a method to protect children and adolescents in research, while ensuring that important studies are not blocked because of unwarranted concerns about research risks.

Project description:BackgroundAfter decades of liberal opioid prescribing, multiple efforts have been made to reduce reliance upon opioids in clinical care. Little is known about the effects of opioid prescribing policies on outcomes beyond opioid prescribing.ObjectiveTo evaluate the combined effects of multiple opioid prescribing policies implemented in a safety-net primary care clinic in San Francisco, CA, in 2013-2014.DesignRetrospective cohort study and conditional difference-in-differences analysis of nonrandomized clinic-level policies.Patients273 patients prescribed opioids for chronic non-cancer pain in 2013 at either the treated (n=151) or control clinic (n=122) recruited and interviewed in 2017-2018.InterventionsPolicies establishing standard protocols for dispensing opioid refills and conducting urine toxicology testing, and a new committee facilitating opioid treatment decisions for complex patient cases.Main measuresOpioid prescription (active prescription, mean dose in morphine milligram equivalents [MME]) from electronic medical charts, and heroin and opioid analgesics not prescribed to the patient (any use, use frequency) from a retrospective interview.Key resultsThe interventions were associated with a reduction in mean prescribed opioid dose in the first three post-policy years (year 1 conditional difference-in-differences estimate: -52.0 MME [95% confidence interval: -109.9, -10.6]; year 2: -106.2 MME [-195.0, -34.6]; year 3: -98.6 MME [-198.7, -23.9]; year 4: -72.6 MME [-160.4, 3.6]). Estimates suggest a possible positive association between the interventions and non-prescribed opioid analgesic use (year 3: 5.2 absolute percentage points [-0.1, 11.2]) and use frequency (year 3: 0.21 ordinal frequency scale points [0.00, 0.47]) in the third post-policy year.ConclusionsClinic-level opioid prescribing policies were associated with reduced dose, although the control clinic achieved similar reductions by the fourth post-policy year, and the policies may have been associated with increased non-prescribed opioid analgesic use. Clinicians should balance the urgency to reduce opioid prescribing with potential harms from rapid change.

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Evaluating inputs of failure modes and effects analysis in identifying patient safety risks.

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Evaluating inputs of failure modes and effects analysis in identifying patient safety risks.

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