Inactive
Notice ID:36C24622Q0283
This is a sources sought announcement only. The purpose of this notice is to conduct market research and obtain information from qualified potential offerors. No formal solicitation document exists at...
This is a sources sought announcement only. The purpose of this notice is to conduct market research and obtain information from qualified potential offerors. No formal solicitation document exists at this time. The Government is not obligated to, nor will it, pay for or reimburse any costs associated with responding to this sources sought synopsis request. This notice shall not be construed as commitment by the Government to issue a solicitation or ultimately award a contract, nor does it restrict the Government to a particular acquisition approach. The Government will in no way be bound to this information if any solicitation is issued. The Charles George Veterans Affairs Medical Center (VAMC), 1100 Tunnel Road, Asheville, NC 28805, is seeking potential sources capable to provide USP 797 Testing services. The NAICS code for this procurement is 541690 Other Scientific and Technical Consulting Services, Size Standard $16.5 Million. Provide all services, labor, supervision, materials, equipment, tools, transportation, technical expertise, insurance, taxes and fees necessary to provide USP 797 Testing services for the Charles George VA Medical Center. The Contractors work must include: Gloved Fingertip and Thumb Sampling and Media-Fill Testing required per Pharmaceutical Compounding-Sterile Preparations 797 Follow procedures in USP 797 (2019 version) and CETA Application Guides (CAGs) USP 797 Demonstrating Competency in Garbing and Hand Hygiene USP 797 Competency Testing in Aseptic Manipulation CAG-011 Gloved Fingertip Testing for Sterile Compounding Personnel CAG-013 Media-Fill Testing for Sterile Compounding Personnel If glove-tip fails, compliance states that an FTEE cannot prepare until a passing glove-tip test is documented Glove-Tip testing required to monitor staff compliance and competency in Compound Sterile Preparation (CSP) Needed for contract Estimate of FTEE to be tested 50 Types of testing to be completed, per FTEE Media-Fill Test (Medium Risk- IV Bag Transfer) x 1 per FTEE, semi-annual 100 tests/year If an FTEE fails a test: re-test required ASAP (within 5 days of notification of failed test) 10 additional re-tests required Gloved Fingertip and Thumb Sampling x 2 per FTEE (2 hands, 5 fingers), semi-annual (subsequent testing) 200 tests/year If an FTEE fails a test: re-test required ASAP (within 5 days of notification of failed test) 20 additional re-tests required Gloved Fingertip and Thumb Sampling (Initial) 3 separate testing of 2 hands (6 samples) Build in quantity for new hires, cross-training, staff returning from extended leave/time out of compounding section ~ 5 FTEE Schedule Both tests to be completed on FTEE on same day Testing schedule to be coordinated with Pharmacy CSP Program Manager and COR, allow for 2 weeks of scheduling for FTEE testing PRIOR TO FTEE competency expiration (testing to be completed by expiration, NOT the results) To be completed during FTEE tour of duty (will include evenings, nights, and weekends, depending on FTEE availability) Surface Sampling required per USP 797 Follow procedures in USP 797 (2019 version) and CETA Application Guides (CAGs) USP 797 Microbiological Air and Surface Monitoring CAG-009 Viable Environmental Monitoring for Sterile Compounding Facilities Sample various locations for growths of microbials, all growth must be identified Media test of surfaces Needed for contract Required testing locations 25 locations/monthly Includes the Segregated Compounding Area (SCA), Contingency Segregated Compounding Area (C-SCA), and Cleanroom Suite Media testing (25 x 12) 300 tests/year If there is a failed test: re-test required after VA cleaning (re-test within 3 days after cleaning/decontamination) Cleaning to occur immediately after a failed test, by VA staff May require specialized decontamination, see below Additional re-test as require per USP 297 within 24 to 72 hours. Schedule Must be completed by the end of 2nd week of each month, calendar days only Must be completed during normal business hours (8AM 4:30PM) Must be coordinated with Pharmacy CSP Program Manager and COR 2 weeks in advance of requested testing date. Room Certifications Air sampling required per USP 797 requirements and CETA Application Guides (CAGs) Needed for contract Spaces x 4 (ISO 7 Anteroom, ISO 7 Buffer Room, ISO 7 HD Buffer Room, C-SCA), semi-annually 8 spaces/year particle count If there is a failed test: VA staff to clean or procure decontamination service (re-test within 3 days after cleaning/decontamination) 3 additional Media testing and particle count tests required Inspection employee certification per USP Hood Certifications ISO 5 Hoods (x6) Needed for contract 6 hoods, semiannual 12 hood certifications If there is a failed inspection: VA staff to clean or procure decontamination services, FMS to repair hood via manufacturer (re-test within 3 days after cleaning/decontamination) 2 additional hood certifications Need Hood manufacturer/serial information (to put in the contract) YES Decontamination Services (NOT IN SCOPE OF USP TESTING CONTRACT) Clean/disinfect per Hazardous Drugs-Handling in Healthcare Settings (USP 800) requirements Spaces x 3 (ISO 7 Anteroom, ISO 7 Buffer Room, ISO 7 HD Buffer Room) Provide 2 space decontamination services Responses to this sources sought notice should include the following: name and address of company, business size (large or small): Please identify your companies socioeconomic categories- 8(a), HUBZone, Services Disabled Veteran-Owned/Veteran-Owned Small Business, other small, small or large. If you are an SDVOSB, VOSB or small business and plan on subcontracting, please provide a plan to show how your company will provide 50% of the work being performed. Also, provide a brief description of qualifications and any other pertinent information which demonstrates the ability to meet the above requirement. Subject line must read: Charles George VAMC USP 797 Testing Services. All capability statements shall be submitted in writing no later than 12:00 PM, February 8, 2022 to the attention of: Emily Donahue, emailed to the address of Emily.Donahue@va.gov. Please don t reply if your company is not capable or interested.
