Blood Donor / Infectious Disease Testing Services

Combined Synopsis/Solicitation

U.S. Naval Hospital Command

Blood Donor Reference Laboratory Testing Services

This is a combined synopsis/solicitation for commercial items prepared per the format in FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotations/offers are being requested and a written solicitation will not be issued. Solicitation N6809621Q2105-- is being issued as a Request for Quotation (RFQ).

Solicitation N6809621Q2105-- and the incorporated provisions and clauses are those in effect through the Federal Acquisition Circulation 2020-09. The North American Industry Classification System (NAICS) code is 541380 - Testing Laboratories. Offerors must be registered in the System for Award Management (SAM) at http://www.sam.gov, in order to be considered for award.

Description of Services requested - Blood Donor / Infectious Disease Testing for the following:

Standard Test Panel in accordance with the Food and Drug Administration regulations and includes the following tests:

• ABO/Rh (including weak-D testing
• Red Cell Alla-Antibody Screen
• Standard Test for Syphilis (STS)
• HBsAg
• Anti-HBc
• Anti-HCV
• Anti-HIV-1/HIV-2
• Anti-Cytomegalovirus
• Anti-HTLV-I/II
• WNV-NAT*
• HIV-NAT
• HCV-NAT
• HBV-NAT
• Chagas Disease Testing
• Zika-NAT*
• Babesia NAT*

The following assays are performed on select donations as requested by US Naval Hospital Guam:

• HLA Ab (TRALI)
• Anti-A/ Anti-B Titers
• Licensed Phenotype Screening - E,e,C,c, and Kell antigens (selective testing is scheduled 1 to 2 times per week.)
• Hemoglobin S performed by the Transfusion Services Laboratory within 24 hours of receipt of sample.
• The MosaiQ COVID-19 Antibody test is an in vitro diagnostic test for the qualitative detection of total (lgM and lgG) antibodies to the SARS-CoV-2 in human serum and EDTA plasma collected in CLIA certified laboratories and/or by healthcare workers at the point-of-care. This test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The MosiaQ COIVD-19 Antibody Assay should not be used to diagnose acute SARS-CoV-2 infection.
• The MosaiQ COVID-19 Antibody test is only for use under the Food and Drug Administration's Emergency Use Authorization.

Confirmatory testing will consist of individually run tests as follows:

• HBsAg Neutralization
• Anti-HCV Confirmatory Testing, Repeat HCV IDT-NAT, if negative then run on Anti-HCV Alternate Manufacturer EIA methodology
• Anti-HIV-1 Western Blot (Bio-Rad) performed at Innovative Blood Resources until Bio-Rad Geenius™ is made available at the Bloodworks Donor Testing Laboratory.
• Anti-HIV-2 EIA until Bio-Rad Geenius™ is made available at the Bloodworks Donor Testing Lab.
• Bio-Rad Geenius™ HIV-1/-2 Supplemental Testing
• Abbott ESA Chagas (Testing performed at Creative Testing Solutions, a qualified sub-contractor)
• HTLV-1/II Blot Confirmatory Testing
• FTA-ABS (Testing performed at Quest Diagnostics, a qualified sub-contractor)
• Vitalant Research Institute (VRI) SARS-CoV-2 Reporter Viral Particle Neutralization (RVPN) testing is performed when the qualitative Anti-SARS-CoV-2 screening test is reactive, to help determine the specificity and relative neutralizing capability of the antibody. The RVPNs represent a safe and rapid way of quantitatively measuring neutralization, by using SARS-CoV-2 Spike glycoprotein pseudotyped onto a rhabdovirus reporter virus. The assay is performed by mixing serial dilutions of serum with constant concentrations of reporter viruses, in equal volumes. The mixture is then added to cell culture monolayers to assess antibody presence. Inhibited reporter virus growth in the cell culture monolayers is indicative of the presence of neutralizing antibody in serum. The SARS-CoV-2 RVPN detects the presence of neutralizing antibody directed against the virus but there is still a potential that cross reactivity with other coronavirus species may occur. FDA recommends neutralizing antibody titration for CCP qualification.

Responsibilities

No. of Donations: 1400 throughout Period of Performance

NOTE: Results must be available within 48 hours of shipment time.

Vendor Must Ship return boxes to USNH Guam

(See attached Performance Work Statement)

Period of Performance: 28 November 2020 to 27 November 2021

The services and items are for the US Naval Hospital Guam (hereinafter referred to as USNH Guam). The Laboratory Department at USNH Guam will inspect/accept the supplies delivered/services performed.

The provision at FAR 52.204-24, Representation on Contracting Telecommunication and Video Surveillance Services or Equipment applies to this solicitation and is incorporated in full text on pages 4 and 5.  The contractor must complete the representation at subparagraph (c) of the provision as part of it offer/quotation.

The provision at Federal Acquisition Regulation (FAR) 52.212-1, Instruction to Offerors-Commercial, applies to this acquisition and is tailored as follows:
Addendum to FAR 52.212-1:
((b)(6) A quotation/offer submitted in response to this combined synopsis/ solicitation must be "Firm-fixed price."
(f)(1) Quotations/offers must be received in the USNH Guam Contracting Office by 02:00PM, Eastern Daylight Time, on Friday, November 8th, 2019.

The provision at FAR 52.212-2, Evaluation--Commercial, applies to this acquisition and is tailored as follows:
Addenda to FAR 52.212-2:
(a) The government contemplates awarding a fixed price purchase order from this solicitation to the responsible offeror whose quotation/offer conforming to the solicitation is the lowest priced quotation/offer.

The provision at FAR 52.212-3, ALT I, Offeror Representations and Certifications -- Commercial Items, applies to this acquisition. The Offeror shall complete only paragraph (b) of this provision if the Offeror has completed the annual representations and certification electronically in the System for Award Management (SAM) accessed through https://www.sam.gov. If the Offeror has not completed the annual representations and certifications electronically, the Offeror shall complete only paragraphs (c) through (u)) of this provision. See the "full text" version of this provision within this announcement.

The clause at 52.212-4, Contract Terms and Conditions -- Commercial Items, applies to this acquisition. There are no addenda to this clause.

The clause at 52.212-5, Contract Terms and Conditions Required To Implement Statutes Or Executive Orders -- Commercial Items (Deviation 2018-O0021)(Sep 2018), applies to this acquisition. There are no addenda to this clause.

To access all clauses referenced in this notice, visit http://farsite.hill.af.mil/

Offerors must be able to utilize the Wide-Area-Work-Flow (WAWF) electronic invoicing as a method of payment. You can access the WAWF at https://wawf.eb.mil  Follow the step-by-step procedures for self-registration.

Submission of Proposal

Only email proposals will be accepted. (Email can be no larger than 5 MB, multiple emails will be accepted)  Email proposal as attachment to Regel A. Agahan, Email: regel.a.agahan.civ@mail.mil

No paper proposals will be accepted. Proposals are due not later than Friday 12:00 PM Local / Guam time on 20 November 2020. No phone calls accepted.

Combined Synopsis/Solicitation

U.S. Naval Hospital Command

Blood Donor Reference Laboratory Testing Services

This is a combined synopsis/solicitation for commercial items prepared per the format in FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotations/offers are being requested and a written solicitation will not be issued. Solicitation N6809621Q2105-- is being issued as a Request for Quotation (RFQ).

Solicitation N6809621Q2105-- and the incorporated provisions and clauses are those in effect through the Federal Acquisition Circulation 2020-09. The North American Industry Classification System (NAICS) code is 541380 - Testing Laboratories. Offerors must be registered in the System for Award Management (SAM) at http://www.sam.gov, in order to be considered for award.

Description of Services requested - Blood Donor / Infectious Disease Testing for the following:

Standard Test Panel in accordance with the Food and Drug Administration regulations and includes the following tests:

• ABO/Rh (including weak-D testing
• Red Cell Alla-Antibody Screen
• Standard Test for Syphilis (STS)
• HBsAg
• Anti-HBc
• Anti-HCV
• Anti-HIV-1/HIV-2
• Anti-Cytomegalovirus
• Anti-HTLV-I/II
• WNV-NAT*
• HIV-NAT
• HCV-NAT
• HBV-NAT
• Chagas Disease Testing
• Zika-NAT*
• Babesia NAT*

The following assays are performed on select donations as requested by US Naval Hospital Guam:

• HLA Ab (TRALI)
• Anti-A/ Anti-B Titers
• Licensed Phenotype Screening - E,e,C,c, and Kell antigens (selective testing is scheduled 1 to 2 times per week.)
• Hemoglobin S performed by the Transfusion Services Laboratory within 24 hours of receipt of sample.
• The MosaiQ COVID-19 Antibody test is an in vitro diagnostic test for the qualitative detection of total (lgM and lgG) antibodies to the SARS-CoV-2 in human serum and EDTA plasma collected in CLIA certified laboratories and/or by healthcare workers at the point-of-care. This test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The MosiaQ COIVD-19 Antibody Assay should not be used to diagnose acute SARS-CoV-2 infection.
• The MosaiQ COVID-19 Antibody test is only for use under the Food and Drug Administration's Emergency Use Authorization.

Confirmatory testing will consist of individually run tests as follows:

• HBsAg Neutralization
• Anti-HCV Confirmatory Testing, Repeat HCV IDT-NAT, if negative then run on Anti-HCV Alternate Manufacturer EIA methodology
• Anti-HIV-1 Western Blot (Bio-Rad) performed at Innovative Blood Resources until Bio-Rad Geenius™ is made available at the Bloodworks Donor Testing Laboratory.
• Anti-HIV-2 EIA until Bio-Rad Geenius™ is made available at the Bloodworks Donor Testing Lab.
• Bio-Rad Geenius™ HIV-1/-2 Supplemental Testing
• Abbott ESA Chagas (Testing performed at Creative Testing Solutions, a qualified sub-contractor)
• HTLV-1/II Blot Confirmatory Testing
• FTA-ABS (Testing performed at Quest Diagnostics, a qualified sub-contractor)
• Vitalant Research Institute (VRI) SARS-CoV-2 Reporter Viral Particle Neutralization (RVPN) testing is performed when the qualitative Anti-SARS-CoV-2 screening test is reactive, to help determine the specificity and relative neutralizing capability of the antibody. The RVPNs represent a safe and rapid way of quantitatively measuring neutralization, by using SARS-CoV-2 Spike glycoprotein pseudotyped onto a rhabdovirus reporter virus. The assay is performed by mixing serial dilutions of serum with constant concentrations of reporter viruses, in equal volumes. The mixture is then added to cell culture monolayers to assess antibody presence. Inhibited reporter virus growth in the cell culture monolayers is indicative of the presence of neutralizing antibody in serum. The SARS-CoV-2 RVPN detects the presence of neutralizing antibody directed against the virus but there is still a potential that cross reactivity with other coronavirus species may occur. FDA recommends neutralizing antibody titration for CCP qualification.

Responsibilities

No. of Donations: 1400 throughout Period of Performance

NOTE: Results must be available within 48 hours of shipment time.

Vendor Must Ship return boxes to USNH Guam

(See attached Performance Work Statement)

Period of Performance: 28 November 2020 to 27 November 2021

The services and items are for the US Naval Hospital Guam (hereinafter referred to as USNH Guam). The Laboratory Department at USNH Guam will inspect/accept the supplies delivered/services performed.

The provision at FAR 52.204-24, Representation on Contracting Telecommunication and Video Surveillance Services or Equipment applies to this solicitation and is incorporated in full text on pages 4 and 5.  The contractor must complete the representation at subparagraph (c) of the provision as part of it offer/quotation.

The provision at Federal Acquisition Regulation (FAR) 52.212-1, Instruction to Offerors-Commercial, applies to this acquisition and is tailored as follows:
Addendum to FAR 52.212-1:
((b)(6) A quotation/offer submitted in response to this combined synopsis/ solicitation must be "Firm-fixed price."
(f)(1) Quotations/offers must be received in the USNH Guam Contracting Office by 02:00PM, Eastern Daylight Time, on Friday, November 8th, 2019.

The provision at FAR 52.212-2, Evaluation--Commercial, applies to this acquisition and is tailored as follows:
Addenda to FAR 52.212-2:
(a) The government contemplates awarding a fixed price purchase order from this solicitation to the responsible offeror whose quotation/offer conforming to the solicitation is the lowest priced quotation/offer.

The provision at FAR 52.212-3, ALT I, Offeror Representations and Certifications -- Commercial Items, applies to this acquisition. The Offeror shall complete only paragraph (b) of this provision if the Offeror has completed the annual representations and certification electronically in the System for Award Management (SAM) accessed through https://www.sam.gov. If the Offeror has not completed the annual representations and certifications electronically, the Offeror shall complete only paragraphs (c) through (u)) of this provision. See the "full text" version of this provision within this announcement.

The clause at 52.212-4, Contract Terms and Conditions -- Commercial Items, applies to this acquisition. There are no addenda to this clause.

The clause at 52.212-5, Contract Terms and Conditions Required To Implement Statutes Or Executive Orders -- Commercial Items (Deviation 2018-O0021)(Sep 2018), applies to this acquisition. There are no addenda to this clause.

To access all clauses referenced in this notice, visit http://farsite.hill.af.mil/

Offerors must be able to utilize the Wide-Area-Work-Flow (WAWF) electronic invoicing as a method of payment. You can access the WAWF at https://wawf.eb.mil  Follow the step-by-step procedures for self-registration.

Submission of Proposal

Only email proposals will be accepted. (Email can be no larger than 5 MB, multiple emails will be accepted)  Email proposal as attachment to Regel A. Agahan, Email: regel.a.agahan.civ@mail.mil

No paper proposals will be accepted. Proposals are due not later than Saturday 05:00 PM Local / Guam time on 18 November 2020. No phone calls accepted.