How to Use This Tool
Review the Principles of Use
- The ASHP Foundation Outsourcing Sterile I.V. Compounding Services Vendor Assessment Tool incorporates regulations from FDA, USP and other federal level guidelines which are subject to change. Applicable regulations can be considered current as of June 2015 and users should check for updates to applicable regulations …
- This tool provides a way to systematically review prospective outsourcing facilities and compounding pharmacies. Outsourcing facilities are a new category of drug compounder that may legally provide non-patient-specific compounded preparations to hospitals and other providers, but must meet current Good Manufacturing Practices (the quality standards applied to FDA-regulated drug manufacturers) and submit to regular FDA inspections. The differences between outsourcing facilities and compounding pharmacies are detailed in ASHP Guidelines on Outsourcing Sterile Compounding Services. For the purposes of this tool, outsourcing facilities and compounding pharmacies will be collectively referred to as "vendors"
- When outsourcing sterile products preparation services, every hospital/health system-based department of pharmacy should take a comprehensive and organized approach to vendor selection.
- Departments of pharmacy are strongly encouraged to engage other key hospital/health system stakeholders in the vendor selection process.
- While this tool is intended to be useful for all health-system/hospital-based departments of pharmacy, its use will vary based on the institution’s size, geographic location, services provided and available resources.
- The ASHP Foundation has attempted to include the assessment questions under the most appropriate category. However, in some cases an assessment question might be applicable to multiple categories.
- While this document is intended to be helpful to hospital/health-system departments of pharmacy in their selection of a sterile products outsourcing organization, it does not purport to establish a standard of care.
- Hospitals/health systems that plan to use this tool as a component of their evaluation of a sterile products outsourcing organization can also use the tool to develop a Request for Proposals (RFP) for these services.
- The ASHP Foundation strongly encourages hospitals/health systems to use this tool along with site visits to ensure a comprehensive review of potential sterile products outsourcing organizations. Items that should be closely evaluated during the site visit are indicated throughout the tool.
- As part of the hospital’s/health system’s overall planning for selection of a sterile products outsourcing organization, see the ASHP Guidelines on Outsourcing Sterile Compounding Services.
- This tool is not intended for use in the evaluation of nuclear pharmacies.
Minimum Requirements for a Vendor
When outsourcing the production of sterile products the first step in vendor evaluation is to see if they meet the minimum requirements. We’ve developed a group of questions that can be used to qualify a vendor. There is not an absolute score for this section. A pie chart will be displayed upon the completion of all of step 1. Areas of green represent the percentage of questions answered that are in compliance with applicable standards based on your answers to the questions. Areas in yellow indicate the vendor is partially compliant based on the applicable standard. Areas in orange indicate areas to follow-up on because you indicated you do not know the answer to the items. Caution should be used in evaluating a vendor with more than 10% orange as this indicates there are likely too many unknowns about that vendor to make an informed decision. Consider reevaluating the vendor once you have further information. The red section of the chart indicates the percentage of questions answered in such a way that the vendor is considered noncompliant with the applicable standards. Once a vendor has been qualified we suggest further assessment of the vendor to determine which vendor is the best fit for your hospital or health-system.
The following questions are designed to help you objectively compare the services offered by potential outsourcing vendors. After answering each question, the Assessment tool provides a score for the vendor and a table to interpret the score.
Use the vendor score and the scoring legend, and the completed Assessments to compare qualified vendors.