"Insourcing" Sterile I.V. Compounding Services

Lost ID

INSOURCING Sterile Compounding Services
Readiness Assessment Tool

Principles for Use

This tool is interactive and may be completed more than once, depending on which medications you think that your organization may benefit from ending your outsourcing contracts and help you define what you may or may not be able to accomplish.

You will be able to save your data and return at a later time to complete the tool. This tool might take several hours to complete because of the complexity of the decision and the many elements to consider.

Having information about current and desired future compounding operations at your organization will expedite the completion of the tool. Information you may consider having readily available as you complete the tool:

  • Current sterile compounding metrics-volume of preparations made and cost
  • Types of preparations being considered for insourcing and anticipated volumes
  • Current staffing levels for and idle time of the cleanroom
  • If desired, additional space requirements for insourcing

The first part of the tool is designed to help determine if your facility and staff are adequate to prepare medications the hospital/health-system is considering bringing back in-house. The second part of the tool addresses the costs and financial implications of decisions you have made. This tool may serve as a basis for you to request the needed capital resources and operational expenses to meet your needs.

The tool walks you through the sections listed in the navigation on the right of the page. This navigation allows users to revisit previously completed sections.

Continue

Introduction

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Section I: Getting Started

  1. Create Assessment

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Section II: Basic Considerations

  1. USP Standards & Regs

  2. USP Standards & Regs (Cont)

  3. Internal Preparation of CSPs

  4. Commercial Alternatives

  5. Compounding Scope

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Section III: Quality Elements and Risk

  1. Product Planning Table

  2. End Product Testing

  3. Stability Testing

  4. Sterility Testing

  5. Risk Analysis

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Section IV: Strategic Planning and Business Cases

  1. Stakeholder Relations

  2. Volumes & Changes Assessment

  3. Staffing Considerations

  4. Clean Room Design Considerations

  5. Space and Clean Room Design Considerations

  6. Clean Room Considerations

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Section V: Implementation

  1. Implementation Process Checklist

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Section VI: Conclusion

  1. End of Insourcing Analysis Tool

View Disclaimer


The information contained in this self-assessment tool is constantly evolving because of ongoing research and improvements in technology and is subject to the professional judgment and interpretation of the involved health care professionals. The ASHP Research and Education Foundation, the expert panel, and external peer reviewers have made reasonable efforts to ensure the accuracy and appropriateness of the information presented. However, any reader of this information is advised that the ASHP Research and Education Foundation, the expert panel, and the external reviewers are not responsible for the continued currency of the information, for any errors or omissions and/or for any consequences arising from the use of the information in the readiness assessment tool in any and all practice settings. Any reader of this document is cautioned that the ASHP Research and Education Foundation makes no representation, guarantee or warranty, express or implied, as to the accuracy and appropriateness of the information contained in this readiness assessment tool and will bear no responsibility or liability for the results or consequences of its use.

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Planned and coordinated by ASHP and sponsored by Baxter Healthcare.