Inactive Local Area Set-Aside (FAR 26.2)

This is a COMBINED SYNOPSIS/SOLICITATION for commercial items prepared in accordance with the format in Subpart 12.6 and is being conducted under FAR Subpart 13; simplified acquisition procedures appl... This is a COMBINED SYNOPSIS/SOLICITATION for commercial items prepared in accordance with the format in Subpart 12.6 and is being conducted under FAR Subpart 13; simplified acquisition procedures apply. VA will conduct the procurement according to a combination of FAR Part 12, Acquisition of Commercial Items and Part 13, Simplified Acquisition Procedures as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. (ii) The solicitation number is 36C24520Q0060 and is issued as a Request For Quotation (RFQ). (iii) The provisions and clauses incorporated into this solicitation document are those in effect through Federal Acquisition Circular 2019-01, fiscal year 2019. Provisions and clauses incorporated by reference have the same force and effect as if they were given in full text. The full text of the Federal Acquisition Regulations (FAR) and Veterans Affairs Acquisition Regulations supplement (VAAR) can be accessed on the Internet at http://www.arnet.gov/far (FAR) and http://vaww.appc1.va.gov/oamm/vaar (VAAR) (iv) This requirement will use the cascading set-aside strategy, compliant with 38 U.S.C. 8127 (AKA Kingdomware). The evaluation of offers received in response to this solicitation will use a tiered or cascading order of precedence. "Tiered evaluation of offers." also known as "cascading evaluation of offers," is a procedure used in negotiated acquisitions when market research is inconclusive for justifying limiting competition to small business concerns or sub-categories of small business concerns. Offers from both small and other than small business concerns will be evaluated in the following tier order: Service-Disabled Veteran-owned Small Business (SDVOSB), Veteran-owned Small Business (VOSB), all other small business concerns, other than small business. The North American Industry Classification System (NAICS) code is 621991, and the size standard is $32.5 Million. (v) This requirement consists of one (1) line items: ITEM NUMBER DESCRIPTION OF SUPPLIES/SERVICES QUANTITY UNIT 0001 Blood Products and Reference Testing Base with 4 one-year options EA Estimated Usage for Base Year 01/01/2020 - 09/30/2020 1 Red Blood Cells 550 EA 2 Red Blood Cells (Irradiated) 22 EA 3 Plasma 81 EA 4 Cryoprecipitate 2 EA 5 Platelet Pheresis 33 EA 6 Platelets (Irradiated) 10 EA 7 Elution 3 EA 8 DAT 25 EA 9 Selected Cell 400 EA 10 ABO Type 8 EA 11 Rh Type 8 EA 12 RBC Ag other than Rh 20 EA 13 Rh phenotype 12 EA 14 Adsorption 15 EA 15 1 RBC Ag Neg/Unit; 86902 30 EA 16 3 RBC Ag Neg/Unit;86902 5 EA 17 Anti-CMV Neg/Test (CMVN) 11 EA 18 6 RBC Ag neg/unit; 86902 2 EA 19 Pt sera Ag scr/unit, 86904 20 EA 20 Zika testing upcharge 550 EA 21 titer, indirect 1 EA 22 2 RBC Ag Neg/Unit; 86902 10 EA 23 4 RBC Ag Neg/Unit; 86902 10 EA 24 misc. adsorption 2 EA 25 urgent routine hours 25 EA 26 IRL Request, WKND 5pm-7am 25 EA 27 IRL Request, HOL 7am-7am 5 EA (vi) To be acceptable, the proposal shall provide/meet all requirements listed below in the Statement of Work. Price must be reasonable and within the Independent Government Cost Estimate (IGCE). Statement of Work A contract is being sought for acquisition of human blood products, transfusion compatibility testing and antibody identification testing. These products will be used for human administration. All blood and blood products shall be collected, processed, labeled, tested, packaged and shipped in accordance with all regulations of the Food and Drug Administration (FDA) and Center for Biological Evaluation and Research (CBER) as described in The Code of Federal Regulations 21 CFR 600, 601, 606, 607, 610, 640, and 660. Blood will be typed for ABO and Rh antigens in accordance with methods recommended in the current addition of Standards for Blood Banks and Transfusion Services and Technical Manual of the American Association of Blood Banks (AABB). A sample of blood from each donation will be tested for syphilis. Whole blood and/or components will not be used for transfusion unless the test is nonreactive. In addition, only blood testing negative for antibody to human immunodeficiency virus (HIV), for hepatitis B surface antigen (HBsAg) and for anti-hepatitis B core antigen (Anti-HBc) will be used for transfusion. Blood and components will not be used for transfusion if the results are outside established limits. If interstate shipment of blood or blood component is involved, the offeror must submit with the offer a statement that such approval has been authorized under section 251 of the Public Health Service Act. The Contractor shall own, control and solely be responsible for any loss, destruction or damage to the blood until delivered or received and accepted. After such delivery or receipt and acceptance, the LAJVAMC shall own the blood. Contractor shall provide the most current version of the Circular of Information for the use of Human Blood and Blood Components at no additional charge to the Government. The Contractor must be capable of providing a delivery time for human blood products not longer than 60 minutes for emergency, unscheduled patient requirements either from the centralized blood bank or one of its affiliated facilities equipped with overstock supplies for just such a purpose. The Contractor will submit invoices weekly, in arrears, for all products delivered since the previous billing cycle. Invoices will be submitted electronically via the OB10 website. DONOR REQUIREMENTS The Contractor must maintain blood donor lists including names, addresses and Social Security numbers. Under no circumstances will the contractor disclose sensitive donor information to the VA. Donor selection must be in accordance with criteria established by the FDA and/or AABB. Each donor shall be tested at least one time for antibodies to Trypanosoma cruzi. BLOOD PRODUCT REQUIREMENTS Whole blood, red blood cells (RBC) and components will be supplied in standard collection containers with appropriate samples for laboratory work. The following tests will be completed by a laboratory accredited by the AABB or equivalent accrediting body prior to delivery: ABO Group Rh Testing to include Weak D testing Unexpected antibodies to red cell antigen screenings Serologic test for Syphilis (S.T.S.) Hepatitis B Surface Antigen (HBsAg) HIV I/II Antibody screening Hepatitis C Virus Antibody (HCV) Anti-hepatitis B Core Antigen (Anti-HBc) HTLV I/II Antibody screening HCV/HIV Nucleic Acid Testing (individual or combined) West Nile Virus testing Apheresis platelets will be tested for bacterial contamination by an FDA approved bacterial culturing method. Any other testing deemed necessary by the AABB. Blood will be labeled as to ABO Group and Rh typing. Immediately after separation of blood components, each component shall be stored in accordance with AABB requirements. Transportation of blood products shall be in clean validated shipping containers, approved for use in the transportation of blood. Contractor shall provide 100% leukocyte reduced RBCs and platelet pheresis (with exception of autologous and directed units). The supplier will also supply non-cellular blood components. Leukocyte reduced random donor platelets and non-leukocyte reduced blood products may be requested on an as needed basis. ORDERING Orders shall be placed electronically, by telephone, or by fax on an as needed basis by an authorized representative of the VA Blood Bank. The VA Blood Bank shall assist the Contractor in establishing a blood inventory system to insure optimal utilization of blood components. DELIVERIES Blood and blood products are to be delivered directly to the Blood Bank on the second floor of the Louis A. Johnson Veterans Affairs Medical Center, 1 Medical Center Drive, Clarksburg, WV 26301. There shall be no delivery charges for routine deliveries. The Contractor shall make every effort to deliver blood products during normally scheduled time frames. Autologous blood is fully tested before being sent out by the Contractor. Preliminary group and screen will have been done by Contractor s staff. Units will be tagged and limited to autologous use only. Autologous blood will be delivered to the blood bank within ten (10) working days of collection, but no later than 24 hours prior to scheduled surgery. Deglycerolized cells shall be delivered to the VA within 4 hours of preparation to assure adequate dating. Each shipment shall be properly packaged and be accompanied by an itemized shipping list. The Contractor will deliver 24-hour plasma unless Fresh Frozen Plasma (FFP) or cryo-reduced FFP is specifically requested. QUALIFICATIONS The Contractor must be licensed and/or certified and/or registered by the FDA and the AABB. The VA will receive credit from the Contractor for blood returned under the following circumstances: Blood suitable for transfusion: The VA may return certain blood products, so long as, in the Contractor s opinion, such blood products meet reissue criteria. Full or partial credit may be given determined by the specific blood product and Contractor s discretion. Reissue criteria is met when the following questions are answered in the positive. Is the blood product(s) in date? Does the blood product(s) have two or more segments? Has the blood product(s) been maintained continuously within the required temperatures? Is the blood product(s) normal in appearance? Is the blood unit container intact? Is the blood product(s) unmodified? Damaged Blood: If blood arrives to the VA Blood Bank in a damaged condition or in a condition rendering the blood unsuitable for transfusion, then the VA Blood Bank personnel will discard any affected blood unless instructed otherwise by the Contractor. Damaged blood is subject to full credit return to the VA. Regulatory Recall: If the FDA or any another regulatory agency requires a recall of blood owned by the Contractor, then the VA Blood Bank shall discard any affected blood unless instructed otherwise by the Contractor. Recalled blood is subject to full credit return to the VA. GOVERNMENT RESPONSIBILITIES The VA does and will continue to promptly inspect blood upon receipt and report any actual or suspected damage, irregularity, testing or labeling error. In addition, the VA does and will continue to promptly report blood lost due to shipping error. The VA will keep complete and accurate records, as required by law, of patients supplied with blood (product names, lot identifications and quantities), any therapeutic adverse effects and complaints and other blood-related information. With regard to the receipt of credit for blood products, before returning or discarding of blood, the VA will contact the Contractor for authorization. In addition, the VA will complete all necessary paperwork and documentation related to the affected blood products. The VA will not attempt to return blood or blood products which do not meet the reissue criteria set forth in Section G.1.a of this document. The VA will comply with the regulations set forth by in 21 CFR 640 with regard to the handling and storage of blood and blood products. The VA Blood Bank shall make available, on an as needed basis, its inventory of blood components. With approval of the VA Blood Bank, any excess of VA s immediate patient requirements may be made available for distribution to other hospitals. The Contractor shall work with the VA to replenish inventory. NOTIFICATIONS The Contractor will provide the following notifications to the VA Blood Bank: When a donor tests negative at the time of donation, but tests reactive for evidence of HIV or HCV infection on a later donation or who is determined to be at increased risk for transmitting HIV or HCV infection Notification within three (3) calendar days. Results of the supplemental testing of the donors described above for HIV or HCV or other follow-up testing required by the FDA Notification within forty-five (45) days of the test. Requirements set forth in 21 CFD 610.48. The VA will report possible transfusion-transmitted infections or other serious complications (adverse events) associated with transfusion which may have resulted from blood. The VA will cooperate with the Contractor s investigation of any adverse event. TERM OF CONTRACT This contract is effective for five (5) years from date of award. The contract is subject to the availability of funds. The Contractor shall perform no services after September 30 of any year until the Contracting Officer authorizes such services in writing. SCHEDULE OF SUPPLIES Line Item Product Red Blood Cells 0001 Red Cells CPD 500mL LeuRed 0002 Red Cells AS-1 450mL LeuRed 0003 Red Cells AS-1 500mL LeuRed 0004 Red Cells AS-3 450mL LeuRed 0005 Red Cells AS-3 500mL LeuRed 0006 Red Cells Aph AS-3 LeuRed 0007 Red Cells Aph AS-3 LeuRed Cnt1 0008 Red Cells Aph AS-3 LeuRed Cnt2 Red Blood Cells (Irradiated) 0009 Red Cells AS-1 450mL LeuRed Irr 0010 Red Cells AS-1 500mL LeuRed Irr 0011 Red Cells AS-1 500mL LeuRed Irr Div1 0012 Red Cells AS-1 500mL LeuRed Irr Div2 0013 Red Cells AS-1 500mL LeuRed Irr Div3 0014 Red Cells AS-1 500mL LeuRed Irr Div4 0015 Red Cells AS-3 450mL LeuRed Irr 0016 Red Cells AS-3 500mL LeuRed Irr 0017 Red Cells AS-3 500mL LeuRed Irr Div1 0018 Red Cells AS-3 500mL LeuRed Irr Div2 0019 Red Cells AS-3 500mL LeuRed Irr Div3 0020 Red Cells AS-3 500mL LeuRed Irr Div4 0021 Red Cells Aph AS-3 LeuRed Irr 0022 Red Cells Aph AS-3 LeuRed Irr Cnt1 0023 Red Cells Aph AS-3 LeuRed Irr Cnt2 Plasma 0024 Plasma <24h CPD 0025 Plasma <24h CPDA-1 0026 Plasma <24h CP2D Cryoprecipitate 0027 Cryoprecipitate/None/NS/<=-18C 0028 Pooled Cryoprecipitate/None/XX/<=-18C Platelet Pheresis 0029 Platelets Aph ACD-A LeuRed 0030 Platelets Aph ACD-A LeuRed Cnt1 0031 Platelets Aph ACD-A<3log11 LeuRed 0032 Platelets Aph ACD-A<3log11 LeuRed Cnt1 0033 Platelets Aph ACD-A LeuRed Cnt2 0034 Platelets Aph ACD-A LeuRed Cnt3 Platelets (Irradiated) 0035 Platelets Aph ACD-A LeuRed Irr 0036 Platelets Aph ACD-A LeuRed Irr Cnt1 0037 Platelets Aph ACD-A LeuRed Irr Cnt2 0038 Platelets Aph ACD-A LeuRed Irr Cnt3 0039 HLA STAT 0040 plt antibody, per well 0041 aby screen 0042 Elution 0043 ABY ID each panel 0044 DAT 0045 selected cell 0046 titer, indirect 0047 ABO Type 0048 Rh Type 0049 RBC Ag other than Rh 0050 Rh phenotype 0051 pretreat chem/drugs 0052 pretreat enzymes 0053 retic harvest 0054 dilution of serum 0055 inhibition of serum 0056 adsorption 0057 unconfirmed antigen negative 0058 1 RBC Ag Neg/Unit; 86902 0059 ARDP high rare Ag/unit 0060 2 RBC Ag Neg/Unit; 86902 0061 Hemoglobin S, per test 0062 3 RBC Ag Neg/Unit; 86902 0063 Import fee red cell 0064 Anti-CMV Neg/Test (CMVN) 0065 4 RBC Ag Neg/Unit; 86902 0066 Unit search fee for RBC 0067 5 RBC Ag Neg/Unit; 86902 0068 Historic Ag neg/unit 0069 6 RBC Ag Neg/Unit; 86902 0070 RBC AgNeg,pheno rare unit 0071 7 RBC Ag Neg/Unit; 86902 0072 86902; Ag type per unit 0073 8 RBC Ag Neg/Unit; 86902 0074 Pt sera Ag scr/unit,86904 0075 HLA Cytotoxic Aby Screen 0076 HLA A&B platelet transfusion 0077 ABY screen for transplant 0078 Aby id HLA 0079 9 RBC Ag Neg/Unit; 86902 0080 Ag Scrn, spec order 1-10 0081 Ag Scrn, spec order 11-20 0082 Ag Scrn, spec order 21-30 0083 Ag Scrn, spec order 31-40 0084 Ag Scrn, spec order 41-50 0085 Ag Scrn, spec order 51-60 0086 Ag Scrn, spec order 61-70 0087 misc. adsorption 0088 prep of cells for ads 0089 Thawing reagent cell 0090 urgent routine hours 0091 urgent after routine 0092 Call in fee (holiday)- product 0093 Platelet testing w/o CPT 0094 IRL-Molecular RBC 0095 IRL-Molecular RBC 0096 IRL-Molecular RBC 0097 IRL-Molecular RBC 0098 IRL-Molecular RBC 0099 IRL-Molecular RBC 0100 IRL-Molecular RBC 0101 IRL-Molecular RBC 0102 IRL-Molecular RBC 0103 IRL-Molecular RBC 0104 platelet Direct 0105 IRL Request, WKND 5pm-7am 0106 IRL Request, HOL 7am-7am 0107 Zika testing upcharge The contract is subject to the availability of funds. (vii) All material shall be delivered to VA Medical Center Clarksburg WV, 1 Medical Center Drive, Clarksburg, WV 26301. (viii) 52.212-1 Instructions to Offerors - commercial Items, applies to this acquisition. There is no addenda to the provision. (ix) 52.212-2, Evaluation - Commercial Items: FAR provision 52.212-2 does not apply to this solicitation. Award will be based on lowest price and meeting or exceeding Statement of Work requirements. (x) 52.212-3 Offeror Representations and Certifications - Commercial Items- the offeror shall complete only paragraph (b) of this provision if the offeror has completed the annual representations and certifications electronically via the System for Award Management (SAM) Website through http://www.sam.gov/portal. If the offeror has not completed the annual representations and certifications electronically, the offeror shall complete only paragraphs (c) through (p) of this provision. (xi) 52.212-4 Contract Terms and Conditions - Commercial Items: applies to this acquisition. (xii) 52.212-5 Contracts Terms and Conditions Required To Implement Statutes or Executive Orders - Commercial Items; the following FAR clauses identified at paragraph b of FAR 52,204-10; 52.212.5 are considered checked and are applicable to this acquisition: 52.204-10, 52.209-6, 52.219-13, 52.219-27, 52.219-28, 52.222-3, 52.222-19, 52.222-21; 52.222-26; 52.222-35, 52.222-36, 52.222-50, 52.223-18, 52.225-1, 52.225-3; 52.225-13, 52.232-34, 52.233-3, 52.233-4. (xiii) 52.217-8 Option to Extend Services, 52.217-9 Option to Extend the Term of the Contract, 52.232-18 Availability of Funds, 52.232-19 Availability of Funds for Next Fiscal Year. Any additional contract requirement(s) or terms and conditions determined by the Contracting Officer to be necessary for this acquisition and consistent with customary commercial practices will be addressed as necessary. (xiv) Questions shall be submitted in writing to Chantey Bost at chantey.bost2@va.gov and Michael Porter at Marci.Garvin@va.gov NLT Wednesday, November 20, 2019. PROPOSALS ARE DUE Friday, November 22, 2019, by 4:00 p.m. eastern standard time (est) to the email addresses identified above. (xvi) Point of contact for this solicitation is Chantey Bost e-mail chantey.bost2@va.gov. All Inquires must be in writing.