Inclusion/Exclusion Criteria

This article describes the inclusion/exclusion criteria for diagnostic quality improvement interventions in the repository

Inclusion Criteria

Relates to improvement of the diagnostic process and/or reduction in diagnostic errors

The National Academy of Medicine provides a detailed conceptual model of the diagnostic process as well as where in the process failures can occur that can lead to diagnostic errors.**  Diagnostic QI interventions included in the repository are processes described in this conceptual model and are generally intended to improve one or more of the following related to diagnosis:

1. Accurate description of the patient’s health problem; 

2. Timely explanation of the diagnosis and appropriate clinical action; or 

3. Communication of the diagnosis to the patient.   

The primary focus of the repository is clinical process improvements.  This can include diagnostic protocols or bundles, but since process improvement differs by clinical setting the determination for inclusion of in repository will be made at the discretion of the SIDM Practice Improvement Committee. 

Submitter represents a healthcare organization that deliver direct patient care

Submitters are health care professionals, health care administrators, quality improvement professionals, health care consultants, researchers, educators, students, and policymakers in healthcare organizations that deliver direct patient care. These include, but are not limited to, office-based primary and specialty care, clinics (urgent and acute), other ambulatory centers (surgical and imaging), community hospitals, academic medical centers, psychiatric hospitals, rehab facilities and VA & military centers.  Organizations that do not provide direct patient care are NOT eligible to submit an intervention, but may partner with an eligible organization as a third-party member of the team. 

Exclusion Criteria 

Medical device feature improvements with no associated clinical process intervention

The focus of the repository is clinical process interventions that improve on the diagnostic process and/or reduce diagnostic errors not medical device feature improvements.  Medical device feature improvements may benefit the diagnostic process, but the connection to clinical process improvements that ultimately benefits patients must be demonstrated.  Determination for inclusion of in repository will be made at the discretion of the SIDM Practice Improvement Committee.  While we recognize medical devices and other products may improve diagnostic quality, the repository is not the appropriate means of dissemination. 

Health service delivery intervention with no evaluation of effect

An intervention without quantitative or qualitative support for a link between the intervention and targeted outcomes or processes is outside the scope of the repository. 

Intervention with no benefits to patients

The immediate outcomes of some interventions, such as interventions for clinical education or improvement of clinical thought processes, may not include direct clinical benefit to patients.  However, identification of the how patients ultimately benefit with respect to diagnostic accuracy, timeliness, and communication of the diagnosis to the patient must be described in order to be included in the repository.  While it is also important to learn about unsuccessful interventions, those are currently outside the scope of the QI repository. 

*FDA “How to Determine if Your Product is a Medical Device”: https://www.fda.gov/medical-devices/classify-your-medical-device/how-determine-if-your-product-medical-device

**Committee on Diagnostic Error in Health Care, Board on Health Care Services, Institute of Medicine, et al. Improving Diagnosis in Health Care. (Balogh EP, Miller BT, Ball JR, eds.). Washington, DC: National Academies Press; 2015. P. 31-144. http://www.nap.edu/catalog/21794. .