Related Concept Videos
01:13Bioequivalence studies: Biowaivers
398
In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
398
01:11Guidelines for Writing Outcome
4.3K
When developing expected outcomes for a patient care plan, the nurse should adhere to the following recommendations:
Patient outcomes reflect the patient's response to the goal rather than what the nurse aims to achieve. Terminology should be observable and measurable to avoid the reader's interpretation. The desired outcome should be realistic and achievable in the designated care timeframe. Expected outcomes should align with adjunctive therapies. The outcome should enhance care...
Patient outcomes reflect the patient's response to the goal rather than what the nurse aims to achieve. Terminology should be observable and measurable to avoid the reader's interpretation. The desired outcome should be realistic and achievable in the designated care timeframe. Expected outcomes should align with adjunctive therapies. The outcome should enhance care...
4.3K
01:19Quality Assurance
3.9K
Quality assurance is the overarching term used to describe the activities employed to ensure the proper performance of a system. These activities can be classified into three categories: quality control, quality assessment, and internal corrective measures. Typically, these activities work cyclically: quality control is performed before and during the analysis, while quality assessment occurs during and after the investigation. Internal corrective measures are implemented based on the findings...
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01:15Nursing Evaluation
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The evaluation stage signals the end of the nursing process. The nurse gathers evaluative data to assess whether or not the patient has attained the expected results. Whereas the nurse collects data in the nursing assessment to identify the patient's health concerns, the evaluation stage data determines if the indicated health issues are resolved. Evaluative data collection includes two sections: the data acquired to evaluate patient outcomes and the time criteria for data collection.
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01:03Data Validation
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Data validation is an essential part of a comprehensive assessment. Validation is confirming or verifying and opening the door to gathering more assessment data as it clarifies vague or unclear data. The process of checking and verifying the collected information is called data validation. The primary purpose of data validation is to ensure data is as free from error, bias, and misinterpretation as possible.
Nursing assessment guides are generally based on holistic models rather than medical...
Nursing assessment guides are generally based on holistic models rather than medical...
7.2K
01:23Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
554
Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
554
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Ensuring better patient outcomes through quality waived testing.
MLO: Medical Laboratory Observer
|August 14, 2015
Summary
Waived tests, often considered low-risk, can lead to errors when instructions are not followed. Adherence to manufacturer guidelines is crucial for accurate waived testing results and patient safety.
Area of Science:
- Clinical diagnostics
- Laboratory medicine
- Patient safety
Background:
- Waived tests are diagnostic tests cleared by the FDA for home use or for use in clinical laboratories that are not subject to the Clinical Laboratory Improvement Amendments (CLIA) regulations.
- Traditionally, waived tests have been perceived as having minimal risk of patient harm.
Purpose of the Study:
- To investigate the potential for patient harm from waived tests.
- To highlight the importance of adhering to testing protocols.
Main Methods:
- Review of literature on waived testing errors.
- Analysis of case studies where non-adherence to instructions occurred.
Main Results:
- Failure to adhere to basic instructions, such as manufacturer insert guidelines, can lead to testing errors.
Conclusions:
- Waived tests are not without risk.
- Strict adherence to procedural guidelines is essential for accurate results and patient safety in waived testing.