CT/GC and SARS-CoV-2 Testing Supplies for the Landstuhl Regional Medical Center, Germany

THIS IS A PRESOLICITATION ANNOUNCEMENT ONLY.

The Regional Health Contracting Office-Europe is planning to issue a solicitation for delivery of CT/GC and SARS-CoV-2 Testing Supplies for the Landstuhl Regional Medical Center (LRMC), Germany.  The resultant contract type will be a Firm-Fixed-Price (FFP) Purchase Order.  It is incumbent upon interested parties to review this site frequently for any updates/amendments to any and all documents.  The solicitation will be issued for full and open competition.  All vendors must be registered in the System for Award Management (SAM) prior to award, and lack of registration shall make a quotation ineligible for award.  Vendors may obtain information on registration and annual confirmation requirements by calling 1-866-606-8220 or via Internet at https://www.sam.gov.

Item      Description                                         QTY        Unit
0001       CT/GC Testing Supplies                  34           Each

The Contractor shall provide reagents compatible for use with the Hologic Panther Fusion Analyzer.  Reagents must be capable of in vitro qualitative detection and differentiation of ribosomal RNA (rRNA) from Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) to aid in the diagnosis of chlamydial and/or gonococcal urogenital disease using the Hologic Panther Fusion System.

Test kits shall be for 8,500 tests.

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*   See Addendum to 52.212-1 for Instructions to Offerors.         *
*   Brand Name or Equal to the below listed Hologic supplies   *
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Including the following at no additional cost:

Aptima Combo 2 Kit (250 Pack)

Aptima Combo 2 Kit (100 Pack)

Tecan 1000 microliter Filtered Tips (960 Tips)

Aptima Urine Collection Tubes (100 Pack)

Aptima Unisex Swab Collection Kit (50 Per Kit)

Aptima Urine Collection Kit (50 Per Kit)

Aptima Multitest Swab Specimen Collection Kit (50 Pack)

Run Kit Panther (for 5000 Tests)

Multi-Tube Unit (MTU) Kit

Panther Waste Bag

Panther Waste Cover

Aptima Universal Fluids Kit, As

Commercial shipping included to the following address at no additional cost:
Landstuhl Regional Medical Center (LRMC)
Building 3738,
66849 Landstuhl, Germany

Item      Description                                         QTY        Unit
0002       SARS-CoV-2 Testing Supplies       80           Each

The Contractor shall provide reagents compatible for use with the Hologic Panther Fusion Analyzer.  Reagents must be capable of conducting nucleic acid extraction of RNA from SARS-CoV-2 isolated and purified from nasopharyngeal, oropharyngeal swab specimens, nasopharyngeal washes/aspirates or nasal aspirates, anterior nasal and mid-turbinate nasal swab from individuals who meet COVID-19 clinical and/or epidemiological criteria in accordance with CDC guidelines.

Test kits shall be for 20,000 tests.

**************************************************************
*   See Addendum to 52.212-1 for Instructions to Offerors.         *
*   Brand Name or Equal to the below listed Hologic supplies   *
**************************************************************

Including the following at no additional cost:

Aptima SARS-CoV-2 Assay, (250-T), CE/IVD

Aptima SARS-CoV-2 Assay Controls, CE/IVD - 1 POS/NEG CE/IVD

Multi-Tube Unit (MTU) Kit

Panther Waste Bag

Panther Waste Cover

Aptima Universal Fluids Kit, As

Advanced Cleaning Solution (255 ml)

Spare Caps, 100TK TCR/Select (100/bag)

Aptima Specimen Aliquot Tubes, Secundary Tubes (100 Pack)

Caps For Specimen Aliquot Tubes (100 Pack)

Spare Caps, 250TK TCR/Sel. (100/bag)

Spare Caps, Amp/Enz/Probe (100/bag)

Spare Caps, Enz (100/bag)

Aptima Specimen Lysis Tubes, SARS-CoV-2 (100 Pack)

Replacement non-penetrable caps

Tecan 1000 microliter Filtered Tips (960 Tips)

Item      Description                                         QTY        Unit
0003       Specimen Lysis Tubes                     200         Each

The Contractor shall provide Specimen Lysis Tubes inclusive of Specimen Transport Medium (STM), compatible for use with the Hologic Panther Fusion Analyzer.

The Government will evaluate each quotation using Simplified Acquisition Procedures under FAR 13.5, Simplified Procedures for Certain Commercial Items, lowest price and technically acceptable quote to the Government.  The Government will evaluate Factor (1) Technical Capability to determine technical acceptability and Factor (2) Price, to determine the successful awardee.

FACTOR 1 – TECHNICAL:  The quoter shall submit a written quote which explains how to comply with the requirements in the request for quote:

SUBFACTOR 1:
Testing supplies shall meet all salient characteristics.  The quoter shall state whether the brand name or an equal product is quoted.  If an equal product is quoted, the quoter shall provide the full name of the offered testing supplies along with item number, manufacturer’s name and all salient characteristics.

SUBFACTOR 2:
Testing supplies shall be compatible for use with the Hologic Panther Analyzer.  If the an equal product is quoted, proof of compatibility with the Hologic Panther Analyzer shall be provided.

Salient Characteristics for CT/GC Testing Supplies

-           Reagents must be capable of in vitro qualitative detection and differentiation of ribosomal RNA (rRNA) from Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) to aid in the diagnosis of chlamydial and/or gonococcal disease using the Panther System.

-           Reagents must be authorized by FDA under at least an Emergency Use Authorization (EUA) for use, capable of producing extracted nucleic acid in accordance with College of American Pathologist (CAP) and CLIP/CLIA/CLSI guidelines.

-           Reagents must be a target amplification nucleic acid probe test.

-           All reagents provided shall be identical to those used in the FDA 510K approval application. If the bulk reagents are produced overseas, they shall be manufactured in conformance with ISO or CE standards AND must be equal to or better than the U.S. products in quality/manufacturing.

-           All reagents must be functional through the life of the reagent (e.g. expiration date). All non-functional reagents (e.g. failed runs), where non-functionality cannot be attributed to technician error, must be replaced by the Contractor.

-           Reagents must be received at the required temperature indicated on the product insert and have a shelf life of at least six (6) months upon receipt at the Receiving Activity (consignee), or as stated within the individual line item (i.e. Delivery Ticket, Invoice).

-           Additional supplies that should included at no additional cost to complete each test include: Aptima Combo 2 Controls Kit (pos/neg), Multi-Tube Unit Kits, Panther Waste Bog, Panther Waste Cover, Aptima Universal Fluids Kit, Advanced Cleaning Solution (255mL), and Spare Caps.

Salient Characteristics for SARS-CoV-2 Testing Supplies

-           Reagents must be capable of conducting nucleic acid extraction of RNA from SARS-CoV-2 isolated and purified from nasopharyngeal, oropharyngeal swab specimens, nasopharyngeal washes/aspirates or nasal aspirates, anterior nasal and mid-turbinate nasal swab from individuals who meet COVID-19 clinical and/or epidemiological criteria in accordance with CDC guidelines.

-           Reagents must be authorized by FDA under at least an Emergency Use Authorization (EUA) for use, capable of producing extracted nucleic acid in accordance with College of American Pathologist (CAP) and CLIP/CLIA/CLSI guidelines.

-           All reagent kits must include amplification, enzyme, probe reagent and Internal Control.

-           All reagents provided shall be identical to those used in the FDA 510K approval application. If the bulk reagents are produced overseas, they shall be manufactured in conformance with ISO or CE standards AND must be equal to or better than the U.S. products in quality/manufacturing.

-           All reagents must be functional through the life of the reagent (e.g. expiration date). All non-functional reagents (e.g. failed runs), where non-functionality cannot be attributed to technician error, must be replaced by the Contractor.

-           Reagents must be received at the required temperature indicated on the product insert and have a shelf life of at least six (6) months upon receipt at the Receiving Activity (consignee), or as stated within the individual line item (i.e. Delivery Ticket, Invoice).

-           Additional supplies that should included at no additional cost to complete each test include: Aptima SARS-CoV-2 Assay Controls (pos/neg), Multi-Tube Unit Kits, Panther Waste Bog, Panther Waste Cover, Aptima Universal Fluids Kit, Advanced Cleaning Solution (255mL), and Spare Caps.

EVALUATION STANDARDS – TECHNICAL: 

The Government will use the following standards to evaluate Technical:

(1) Acceptable – Quote clearly meets the minimum requirements of the solicitation.

(2) Unacceptable – Quote does not clearly meet the minimum requirements of the solicitation.

FACTOR 2 – PRICE.

(1)  Prices will be determined reasonable based on adequate price competition.  The determination of relative overall price to the U.S. Government will be established by totaling the proposed price for the entire period of performance.

(2)  Proposed prices should include total cost of performing each task.

(3)  The total amount of all CLINs will be the total evaluated price for each quote.