Attachment 2 - Past Performance Self Certification Worksheet.docx
DOCX document 18 KB Posted
- Solicitation number
- HT940626QE114
- Issued by
-
Defense Health Agency
About this file
This is a Past Performance Self-Certification Worksheet for vendors responding to a Request for Quote (RFQ) for Extracorporeal Shock Wave Therapy (ESWT) Systems. The worksheet is designed for offerors to self-certify their qualifications and performance history regarding ESWT systems, specifically Storz Shockwave Therapy Systems, provided to commercial or government clients within the past three years. The solicitation is issued by the Defense Health Agency for Winn Army Community Hospital and Martin Army Community Hospital under solicitation number HT940626QE114, conducted as full and open competition for commercial items in accordance with FAR 12.2.
Offerors must complete vendor information sections including company name, CAGE Code/UEI, and point of contact details, followed by self-certification responses addressing three critical compliance areas: any FDA Class I, II, or III recalls within the past three years; any infection control issues, FDA observations, or customer complaints related to ESWT devices or applicators; and any early contract terminations for cause. For each affirmative response, vendors must provide detailed narratives explaining the cause and corrective actions taken. The worksheet must be completed and signed by an authorized representative certifying that all information provided is current, accurate, and complete.
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Other files
| File | Type | Posted |
|---|---|---|
| RELEASED HT940626QE114.pdf | ||
| Attachment 1 - Statement of Work - Shockwave Therapy System FINAL.docx | DOCX document |
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Attachment 2 - Contractor Past Performance Self-Certification Worksheet
Instructions to Offeror: Please complete all sections below to self-certify your past performance regarding Extracorporeal Shockwave Therapy (ESWT) systems within the past three (3) years.
Vendor Information Company Name: ___________________________ CAGE Code / UEI: ___________________________ Point of Contact (Name/Email): __________________________
History: Briefly describe the volume and scope of Storz Shockwave Therapy Systems currently provided to commercial or government clients.
Self-Certification
1. Has the offeror (or any of its products) been subject to any FDA Class 1, II or III recall within the past three (3) years?
☐ Yes ☐ No If yes, please provide a brief narrative detailing the cause and corrective actions taken.
2. Has the offeror had any infection control issues, FDA observations or customer complaints related to ESWT devices or applicators within the past three (3) years?
3. Has the offeror had any early contract terminations for cause within the past three (3) years?
Authorized Signature By signing below, I certify that the information provided is current, accurate, and complete.
Signature: ___________________________ Date: _________________ Printed Name & Title: ___________________________
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