SOW - Pharmacy Fingertip Testing.docx
DOCX document 18 KB Posted
- Attached to
- Q301-- Pharmacy Gloved Fingertip and Media Filled Testing Federal contract opportunity
- Solicitation number
- 36C25626Q0437
About this file
This is a Statement of Work (SOW) for aseptic technique evaluation services required by the Michael E. DeBakey VA Medical Center (MEDVAMC) in Houston, Texas. The contractor must provide one to two Controlled Environment Testing Association (CETA)-certified technicians to perform compliance testing in accordance with U.S. Pharmacopeia (USP) standards for sterile compounding personnel. The scope of work includes: gloved fingertip and media-fill testing for existing personnel; initial evaluations for new employees involving three observations of garbing and gloving procedures with fingertip tests after each donning and medium-risk media-fill monitoring; hazardous drug wipe testing using an accredited laboratory testing kit to analyze samples for Fluorouracil, Cyclophosphamide, Ifosfamide, Methotrexate, and platinum-containing drugs; and collection of additional fingertip plates and surface samples per latest USP standards. All testing and reporting must comply with USP requirements, with detailed reports provided listing each staff member, room, and hood on individual pages.
The contract is being pursued as a pre-solicitation through a Sources Sought Notice under Solicitation Number 36C25626Q0437. The requirement falls under NAICS code 541380 (Testing Laboratories and Services) with a small business size standard of $19 million, and is classified under PSC code Q301 (Medical Reference Laboratory Testing). Testing shall be performed on an as-needed basis as requested by MEDVAMC Pharmacy Service. The government will provide site access, escorts, adequate space for testing activities, and necessary contact information. The primary point of contact is Sharon Bondy, Pharmacy Health System Specialist, at Sharon.Bondy@va.gov. The solicitation is anticipated to be issued shortly following the sources sought phase.
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| File | Type | Posted |
|---|---|---|
| RFI - 36C25626Q0437.docx | DOCX document |
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Text version
Michael E DeBakey (MEDVAMC) Statement of Work for Aseptic Technique Evaluation via Fingertip Testing for Sterile Compounding Personnel
1. Background The MEDVAMC Pharmacy Service must comply with the U.S. Pharmacopeia (USP) <797> Pharmaceutical Compounding-Sterile Preparations standards. USP <797> is an enforceable federal guideline that establishes comprehensive quality standards for sterile compounding procedures.
To ensure the safety and sterility of compounded medications, pharmacies operating under USP <797> must conduct regular personnel qualification and environmental monitoring. Fingertip testing is a critical component used to assess the aseptic technique of sterile compounding personnel. It helps identify potential contamination risks and ensures compliance with aseptic standards, evaluating microbial contamination from gloved hands after garbing and during compounding activities.
This testing supports compliance, mitigates risk, and ensures product integrity in sterile compounding operations.
2. Scope of Work The contractor shall perform the following services in accordance with USP <797> and USP <800> requirements:
· Gloved Fingertip and Media-Fill Testing Perform gloved fingertip and media-fill testing as required by USP <797>. Technicians should observe gowning and compounding techniques and monitor medium-risk media-fill testing. A detailed report of findings shall be provided.
· Initial Evaluation for New Employees Conduct initial evaluations for new employees by observing garbing and gloving procedures three times. Perform fingertip tests for each hand after each donning and monitor medium risk media fill testing. Provide a detailed report of findings.
· Hazardous Drug Wipe Testing Perform hazardous drug wipe testing as required by USP <800>. The contractor shall use a testing kit provided by an accredited laboratory, which will analyze samples for Fluorouracil, Cyclophosphamide, Ifosfamide, Methotrexate, and platinum-containing drugs. A detailed report of findings shall be provided.
· Additional Fingertip and Surface Sampling Collect additional fingertip plates and surface samples as required by the latest USP <797> standards. These samples shall be included in the final testing protocol.
3. Contractor Responsibilities
· Provide one to two Controlled Environment Testing Association (CETA)-certified technicians to perform the required testing at MEDVAMC.
· Ensure all testing and reporting comply with USP <797> and USP <800> standards.
· Provide report of test results listing each staff member, room and hood on individually per page.
4. Government Responsibilities
· Provide site access and escorts to the designated testing areas.
· Ensure adequate space for testing activities.
· Provide necessary contact information and authorization for coordination with U.S. Government points of contact.
5. Location Michael E. DeBakey VA Medical Center 2002 Holcombe Blvd Houston, TX 77030
6. Timeframe Testing shall be performed on an as-needed basis, as requested by MEDVAMC Pharmacy Service.
7. Pharmacy Point of Contract (POC) Sharon Bondy Pharmacy Health System Specialist Email: Sharon.Bondy@va.gov
File details come from the government source that posted it. Updated .