SOURCES SOUGHT
65 -- collection and sale of recovered human plasma
- Notice Date
- 6/8/2016
- Notice Type
- Sources Sought
- NAICS
- 325414
— Biological Product (except Diagnostic) Manufacturing
- Contracting Office
- Department of the Army, U.S. Army Medical Command, MEDCOM, North Atlantic Regional Contracting Office, 8901 Rockville Pike, Bldg 54, Bethesda, Maryland, 20889, United States
- ZIP Code
- 20889
- Solicitation Number
- W91YTZ-16-R-0069
- Archive Date
- 7/1/2016
- Point of Contact
- Mary A. Mitchell-Martin, Phone: 9106432119
- E-Mail Address
-
mary.a.mitchellmartin.civ@mail.mil
(mary.a.mitchellmartin.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- PRE-SOLICITATION NOTICE: The Regional Health Contracting Office - Atlantic (Provisional), (RHCO-A) (P), Womack Army Medical Center intends to solicit, negotiate and award a Firm, Fixed Priced with an economic price adjustment, Basic Agreement for: This contract is for one base year and four option years. It is for the collection and sale of recovered human plasma, expired platelets, and expired red blood cells from Womack Army Medical Center (WAMC), Blood Services; establishment and maintenance of a monetary account from the sale of expired blood products; and the purchasing of donor incentives from the established account under the authority of 10 USC 1095, and Army Regulation (AR) 40-3 Medical, Dental, and Veterinary Care Chapter 5.6 Disposition of Blood Products; and HSC Regulation 40-19, Annex A, and AR 40-2, Chapter 12. WAMC Blood Services estimates an annual collection of 2500 liters of recovered plasma and 200 units of expired red blood cells. *** No compatibles or substitutes will be accepted, this is considered all or none. This notice is not a request for competitive proposals, however, if you have informational brochures regarding this product you may send them to Ms. Mary Mitchell Martin. mary.a.mitchellmartin.civ@mail.mil No telephonic request will be returned.*** 1. CONTRACTOR REQUIREMENTS: a) The Contractor shall be FDA -registered for expired blood collection. b) The Contractor shall credit the recovered plasma to a special account maintained specifically for this agreement. The contractor shall provide the WAMC Contracting Office Representative (COR) Office with a monthly statement of products ordered against the Plasma Exchange Agreement. Statements shall be itemized and show credits for plasma, payments against Government orders placed, and balance remaining in the account. Contractor shall furnish a monthly statement of the account to the COR indicating: a. Credits accumulated for plasma accepted. b. Cost of items shipped against WAMC Blood Services order. c. Balance remaining. c) The Contractor shall credit WAMC in the negotiated amount per liter of acceptable plasma or the unit price of expired blood products (apheresis platelets or red blood cells). Unit Price may be adjusted at the going national market rate at the six-month mark. Market rate will be established by a mean average of the national average. The Contractor will furnish a letter stating the current market pricing to the Contracting Officer prior to commencement of re-negotiations. The Contracting Officer will evaluate contract price and current market price. New unit price may be established based upon this evaluation. d) The Contractor shall furnish all boxes and labels for preparing product(s) for shipment. The Contractor labels shall conform to Section 351 of the PHS act and contain the statement, "Caution-For Use in Non-Injectable Products Only". The Contractor shall provide for pick up or pay all shipment costs of recovered plasma. e) The Contractor shall pick up product(s) at the Fort Bragg Blood Donor Center, WAMC or an alternate site. f) The Contractor shall weigh and record the volume of each shipment with the donor number and bleed date. A packing list shall be submitted with each shipment. A copy of the plasma record shall be furnished to the COR. g) The Contractor shall provide proof of destruction to the COR of any government furnished plasma rejected by vendor as unsuitable. The Contractor shall identify each unsuitable unit by donor number. A copy of this record will be provided to the COR. h) Products to be ordered: a. Products to be ordered will be items classified as biologics, official reagents, or donor center supplies which will be applied against the existing order balance. The COR will identify the source of the donor products. Invoice shall be provided to the Contractor. b. All shipments shall be FOB WAMC as designated by WAMC Blood Services. c. Each order placed by WAMC will be clearly identified as "Plasma Exchange Agreement Order". d. Delivery will be made directly to the Fort Bragg Blood Donor Center, WAMC, or alternate site. 2. GOVERNMENT REQUIREMENTS: a) The Government shall furnish frozen recovered plasma and expired blood products: apheresis platelets and packed red blood cells that are tested and negative for all viral marker screening tests and other testing as required by current FDA guidelines for the blood banking industry, i.e.: • Tested and negative for, antibodies to HIV and HCV, and non-reactive to HbsAg • Tested for Anti-HBc and appropriately labeled • Tested and negative for Anti-HTLV-I • Tested and negative for STS • Tested and negative for Chagas • Tested and negative for WNV b) The Government will insure donor records include: donor number, collection date, and type of anticoagulant used. c) The Government will furnish Certificate of Analysis stating that all units are tested and negative for Anit-HIV I/II, Anti-HCV, HBsAg, Anti-HTLV-I, STS, Anti-HBc, HCV and HIV by Nucleic Acid Test (NAT) signed by COR, Blood Donor Center Technical Supervisor, or their designee. d) The Government will insure that plasma is only for donors whose blood is acceptable for transfusion where CPD, CPDA-1, AS-1, AS-3, or AS-5 has been used as the anticoagulant. e) The Government will insure that plasma is separated from red blood cells within 24 hours of collection and frozen. f) The Government will insure that recovered plasma will be retained in single collection bags and will not be pooled. g) The Government will collect, label, pack, and maintain record keeping responsibilities for these products. h) Government will label each plasma container with the following: • Name of donor center • Donor or bleeding number • Testing per recovered specifications • Date blood extracted • Date plasma extracted • Volume of plasma container • Label shall state: "Recovered Plasma CAUTION: For use in Manufacturing Non-Injectable Products Only-Not for use in products subject to license under Section 351 of Public Health Services Act". i) The Government will insure that recovered plasma will appear normal (straw or amber color) and contain only a minimal amount of fatty material, hemoglobin, or red cells. Any deviation will be rejected. j) The Government will collect plasma from FDA-approved Donor Centers. k) The Government will appoint in writing a trained COR to monitor contract and audit accounts.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/MEDCOM/DADA15/W91YTZ-16-R-0069/listing.html)
- Place of Performance
- Address: Dept. of the Army, Womack Army Medical Center (WAMC), MCXC-CT 2817 Reilly Road, Fort Bragg, North Carolina, 28310, United States
- Zip Code: 28310
- Zip Code: 28310
- Record
- SN04143307-W 20160610/160608234908-a64fe3a76b85b644be7b1184430171bf (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |