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Module 4 • Quality & Safety
Protocol Development & Quality Improvement
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Protocol Development & Quality Improvement
Jaime Robenolt Gray ~3 min read Module 4 of 20
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Protocol Development and Quality Improvement

B.Goals of a Gap Analysis – To provide the project team with an understanding of the differences between

current and best practices. An assessment must be made of the barriers that exist before best practice can be

implemented successfully. A Gap Analysis should be conducted using the following steps. Using a tool to

track best practices, future state, gaps, and solutions is helpful to keep all information organized and track

the progress of the change to be implemented.

1

Identify best practices and determine/define what the future state should be.

2Identify and review current state practices.
3

Shadow processes or β€œWalk-the-Line” to experience what the current state is like.

4

Compare ideal or future state to the current state to identify gaps.

This can be categorized as fully compliant, partially compliant, in progress, noncompliant, or

potentially not applicable, depending on the practice site.

5

Evaluate potential solutions to bridge the gaps to achieve the future state.

6

Implement change management with timeline goals for successful progress.

7

Monitor the progress of implemented solutions to ensure the change is sustained.

C.Best Practice Evaluation
1

Review of the primary literature

2Benchmarking against gold standards such as:

ISMP Best Practices

ISMP Safety Alert newsletters

Published guidelines such as USP 797 or USP 800

d.The Joint Commission and National Patient Safety Goals

CMS Core Measures

3

Survey practitioners – Feedback from practitioners (e.g., ICU pharmacists, nurses, physicians) may be

helpful when best practices have not been published or their buy-in is essential

Survey strategies

Have a single well-defined objective.

ii.

Keep the survey short.

iii.

Assure respondents that survey responses will be kept anonymous (if possible).

iv.

Survey a large-enough sample to ensure meaningful results.

Explain the purpose of the survey, and how you intend to use the results, in your invitation/

greeting page.

vi.

Spell out the time expectations in your invitation and on the greeting page.

vii.

Survey the appropriate people.

viii.

Design the survey for easily measurable results.

ix.

Evaluate one concept per question.

Avoid biasing the response.

xi.

Limit the number of required questions.

xii.

Question order matters – The first question or two should be easy and interesting.

xiii.

Create a logical flow to the questions.

xiv.

Test the survey.

xv.

Share the results and actions with the respondents.

D.A gap analysis for medication safety should include strategies for prevention and mitigation, assessment

and detection, therapeutic use, critical thinking and knowledge, and education. A gap analysis should also

include policies, procedures, protocols, guidelines, competencies, patient care models, educational methods,

and other key components to maximize efficacy and prevent medication errors and harm.

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