SOLICITATION NOTICE
65 -- Sodium Citrate Stability Testing
- Notice Date
- 8/13/2019
- Notice Type
- Combine Synopsis/Solicitation
- NAICS
- 325412
— Pharmaceutical Preparation Manufacturing
- Contracting Office
- Department of Veterans Affairs;Network Contracting Office (NCO) 10;6150 Oak Tree Blvd., Suite 300;Independence OH 44131
- ZIP Code
- 44131
- Solicitation Number
- 36C25019Q1336
- Response Due
- 8/16/2019
- Archive Date
- 9/15/2019
- Point of Contact
- Tiera Sims
- Small Business Set-Aside
- N/A
- Description
- Combined Synopsis Solicitation: Stability Testing General: This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR subpart 12.6 as supplemented with additional information included in this notice. This notice constitutes the only solicitation; quotations are being requested and a written solicitation will not be issued. The solicitation number is 36C25019Q1336 and is issued as a Request for Quote (RFQ). This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2019-03, effective June 22, 2019. This procurement is unrestricted. This requirement will be awarded on all-or-none basis. The applicable North American Industry Classification System Code (NAICS) is 325412 and the small business size standard is 1,250 employees. Line items: ITEM NUMBER DESCRIPTION OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT 0001 1.00 EA Sodium Citrate Stability Testing GRAND TOTAL 3. Statement of Work: PURPOSE: The purpose of this Statement of Work (SOW) is to develop a firm fixed price purchase order to be used by Cleveland Veterans Affairs Medical Center (CLE VAMC) for the purchase of a stability indicating study for two compounded preparations of sodium citrate. SCOPE OF SERVICE: The contractor shall develop and validate stability testing for sodium citrate. OBJECTIVE: In order to demonstrate stability Pharmacy Service is looking to have the contractor develop and validate stability indicating methods for sodium citrate 4% solution, and to test their packaged product for chemical, microbiological, and physical properties over a ten-day period. The assigned beyond use date will stay within USP recommended dating for sterility. Stability needs to be determined for Sodium Citrate 4% Solution in both 5mL and 10mL BD Luer-Lok syringes. The contractor shall provide a final report with their findings. REQUIREMENTS/TASKS: Contractor shall develop and validate stability indicating methods for sodium citrate using the following conditions: Product Description: Sodium Citrate 4% Solution Relevant NDC numbers: 00942-9505-10 (Sodium Citrate 4%) 08290-3096-46 (BD 5mL syringe) 08290-3029-95 (BD 10mL syringe) Product Appearance: Clear, colorless solution free from visible particles Maximum batch size: 500 Description of the container and fill volume: 3mL Sodium Citrate 4% in 5mL and 10mL BD Luer-Lok Syringes Type of container: Single-dose container Route of administration: Cath Lock Storage requirements: Refrigerated Target expiration/beyond-use-date: 10 days Preferred number of time points: 3, 4, 5, 8, and 10 days Day 0: Considered to be the day the product was compounded Contractor shall provide a detailed work plan and briefing for the VA pharmacy project team. Contractor shall provide a final stability report with findings. The compounder and verifying pharmacist shall review each procedure in the compounding process. To ensure accuracy and completeness, the compounder and verifying pharmacist shall inspect the finished preparation to ensure that it appears as expected, shall investigate any discrepancies, and take appropriate action before the preparation is released. PLACE OF PERFORMANCE: The facility does have a loading dock. Delivery: 30 Days ARO FOB Point: Destination Cleveland VAMC 10701 East Blvd. Cleveland, OH 44106 GOVERNMENT HOLIDAYS: National holidays observed by the Federal Government are as follows: New Year's Day 1 January Martin Luther King's Birthday Third Monday in January President's Day Third Monday in February Memorial Day Last Monday in May Independence Day 4 July Labor Day First Monday in September Columbus Day Second Monday in October Veterans Day 11 November Thanksgiving Day 4th Thursday in November Christmas Day 25 December If a holiday falls on Sunday, the following Monday will be observed as the National Holiday. When a holiday falls on a Saturday, the preceding Friday is observed as a National Holiday by the U.S. Government agencies. Also included would be any day specifically declared by the President of the United States of America as a National Holiday. Applicable Provisions and Clauses: The following clauses apply to this acquisition: FAR 52.212-4, Contract Terms and Conditions - Commercial Items, with the following added as addenda to the clause, Addendum to 52.212-4 Contract Terms and Conditions-Commercial Items; 852.203-70; 852.219-10; 852.232-72; 852.246-71; FAR 52.252-2; 52.232-40; http://www.acquisition.gov/far/index.html, and http://www.va.gov/oal/library/vaar/index.asp (end of addendum 52.212-4) 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders (of which 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-35, 52.222-36, 52.222-37, 52.223-18, 52.225-1, 52.225-13, and 52.232-34 are applicable). The following provisions apply to this acquisition: 52.212-1, Instructions to Offerors-Commercial; 52.232-38, and http://www.va.gov/oal/library/vaar/index.asp (end of addendum 52.212-1) 52.212-2 evaluation factors: Technical; Delivery; Past Performance; and Price. 5. Offer Evaluation and Award: This is a competitive Request for Quotations (RFQ) that will be evaluated under FAR Part 12 and 13. The Government will issue a Firm-Fixed Price Purchase Order resulting from this solicitation to the responsible offeror whose offer conforms to the requirements within this solicitation and will be the most advantageous to the Government. Best Value will be how the quotes are evaluated. The following factors will be used in evaluation: A price comparison along with Technical Acceptability, Delivery, and Warranty. An Offeror s initial quote shall contain the best terms from a price and technical standpoint. Offerors are reminded that representatives from your company SHALL NOT contact any Cleveland VAMC personnel to discuss this RFQ during the solicitation and evaluation process. 6. Procedure for submitting documents to the Department of Veterans Affairs. DOCUMENTS THAT ARE TO BE PROVIDED TO THE CONTRACTING OFFICER WILL BE SUBMITTED USING THE APPROPRIATE VEHICLE BELOW. email: tiera.sims@va.gov 7. Submission of Offer. All information shall be submitted in the manner described below and offerors who do not submit all information may not be considered for award. Contractor shall provide an authorized distribution letter. The Contractor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor, or authorized Contractor reseller for the proposed equipment/system such that the OEM warranty and service are provided and maintained by the OEM. All warranty and service associated with the equipment/system shall be in accordance with the OEM terms and conditions. The Contractor shall provide new items ONLY; no remanufactured or "gray market" items. All items must be covered by the manufacturer's warranty. Quote must be good for 90 calendar days after close of this Combined Synopsis Solicitation. This solicitation requires registration with the System for Award Management (SAM) prior to award, pursuant to applicable regulations and guidelines. Registration information can be found at www.sam.gov. CONTRACTORS MUST STATE THEIR BUSINESS SIZE when submitting their quote AND if the item is on an FSS/GSA schedule awarded to the Contractor include the schedule information on your quote. Quotes are to be broken out to include line item pricing for each line item. RESPONSES ARE DUE: Friday, August 16, 2019 at 4PM EST. Offers will only be accepted electronically via e-mail to tiera.sims@va.gov. Enter RFQ 36C25019Q1336 Stability Testing in the email subject line. NOTE: THIS NOTICE WAS NOT POSTED TO FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (13-AUG-2019); HOWEVER, IT DID APPEAR IN THE FEDBIZOPPS FTP FEED ON THIS DATE. PLEASE CONTACT 877-472-3779 or fbo.support@gsa.gov REGARDING THIS ISSUE.
- Web Link
-
Link To Document
(https://www.fbo.gov/spg/VA/BreVAMC/VAMCCO80220/36C25019Q1336/listing.html)
- Place of Performance
- Address: Louis Stokes Cleveland VAMC;10701 East Blvd.;Cleveland, OH
- Zip Code: 44106
- Country: US
- Zip Code: 44106
- Record
- SN05403193-F 20190815/190813230028 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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