Insourcing Sterile Compounding Services Readiness Assessment Tool

INSOURCING Sterile Compounding Services
Readiness Assessment Tool

Note: It is anticipated that the Assessment Tool will be updated to reflect final changes in USP Chapter <797>. In the meantime, its concepts reflect the current official version of USP Chapter <797> (revised 2008) and are valuable for sites assessing insourcing readiness.

Introduction

The ASHP Foundation Insourcing Sterile Compounding Services Readiness Assessment Tool provides a systematic process to determine a hospital’s/health-system’s operational readiness for insourcing or internalizing production of compounded sterile preparations (CSPs) that are being provided by an outside vendor (outsourced). The contents of this tool can also be considered as part of a comprehensive organizational analysis to identify the best source for compounded sterile preparations. It is anticipated that the assessment tool will be updated to reflect final changes in USP Chapter <797>; in the meantime, its concepts are valuable for sites undergoing the decision-making process.

The tool consists of questions and lists of considerations. The tool tracks your answers and items for follow-up and creates a final report that can be downloaded as a PDF upon completing the assessment. The final report provides a checklist of items that need to be addressed, information that may need to be gathered, and data to be collected. This tool will not provide a justification that advocates for or against insourcing at a particular facility but rather helps focus follow-up efforts needed to make a decision.

This tool can be used to evaluate low-, medium-, and high-risk compounds. This tool is NOT intended for use in the evaluation of nuclear pharmacy and hazardous drug preparation or insourcing.

Begin New Assessment Resume Existing Assessment

Introduction

Section I: Getting Started

Create Assessment

Section II: Basic Considerations

USP Standards & Regs
USP Standards & Regs (Cont)
Internal Preparation of CSPs
Commercial Alternatives
Compounding Scope

Section III: Quality Elements and Risk

Product Planning Table
End Product Testing
Stability Testing
Sterility Testing
Risk Analysis

Section IV: Strategic Planning and Business Cases

Stakeholder Relations
Volumes & Changes Assessment
Staffing Considerations
Clean Room Design Considerations
Space and Clean Room Design Considerations
Clean Room Considerations

Section V: Implementation

Implementation Process Checklist

Section VI: Conclusion

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.

"Insourcing" Sterile I.V. Compounding Services