Laboratory Testing Supplies for the Landstuhl Regional Medical Center (LRMC), Germany

The Regional Health Contracting Office-Europe issued a solicitation for delivery of Laboratory 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 (555) 000-0000 or via Internet at https://www.sam.gov. QUOTE SUBMISSION 1. INSTRUCTION ELECTRONIC Quote. Quoters may submit electronic quote in response to this Request for Quote. The quote must be received by the quote due date/local time as specified in block 8 of the SF 1449 cover page to the inbox of the following email address: contact@example.gov Vendors may call Mr. Henning Mayer-Goldstein at +49 (6371) 9464 6789 to verify receipt of the quote. If the vendor chooses to email the quote, the Government will not be responsible for any failure of transmission or receipt of the quote, or any failure of the vendor to verify receipt of the emailed quote. FORMAT and SIZE: Each paragraph shall be separated by at least one blank line. A standard, 12-point minimum font size applies. Margins: Top, Bottom, Left, Right - 1 Page Size, Width - 8.5 Page Size, Height - 11 or DIN A4 size. Tables and illustrations may use a reduced font size not less than 8-point and may be landscape. Page size 11x17 or DIN A3 size may be used where needed for readability, however, each printed side of an 11x17 or A3 size page will count as two pages. Page limitations shall be treated as maximums. If exceeded, the excess pages will not be read or considered in the evaluation of the quote and (for paper copies) will be returned to the quoter as soon as practical. The technical quote shall address how you will comply with the requirements set forth in the line item description and must clearly explain each of the technical subfactors (see paragraph 52.212-2 for details). The following is excluded from the page count: copies of certificates, price schedule, completed FAR 52.212-3 Quoter Representations and Certifications - Commercial Items, and acknowledgement of any amendments issued. Page Limitations. Page limitations shall be treated as maximums. Pages in excess of the below limitations will be removed and disregarded during the evaluation. When both sides of a sheet display printed material, it shall be counted as two pages. Each page shall be counted except the following: covers, tab dividers, title pages, glossaries, and table of contents/file index. Also, page limits are applicable to legible tables, charts, graphs and figures used wherever practical to depict organizations, implementation schedules, plans, etc. The quote shall consist of the following sections and be limited by the maximum page limit. Section # Section Title Maximum Page Limit per Section Section 1 Factor 1 - Technical 20 pages Section 2 Factor 2 - Prices on SF 1449 2 pages, if required (completed and signed) (in addition to the SF 1449) QUESTIONS. Prospective quoters are strongly encouraged to submit any questions regarding this Request for Quote no later than three (3) business days prior to the request for quote due date specified in block 8 of the SF 1449 cover page. Questions can be emailed to contact@example.gov. All questions received will be answered officially through an amendment to the Request for Quote for distribution to all prospective quoters. Questions received after the CET cut-off date/time will not be accepted by the Government. 52.229-11, Tax on Certain Foreign Procurements - Notice and Representation. Ensure you provide the completed provision and have read the clause at FAR 52.229-12, Tax on Certain Foreign Procurements. 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 compatible for use with the Hologic Panther Analyzer. Reagents must be capable of in vitro qualitative detection and differentiation of ribosomal RNA (rRNA) from Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) to aid in the diagnosis of chlamydial and gonococcal disease using the Hologic 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: Combo 2 Controls Kit (pos/neg), Multi-Tube Unit Kits, Waste Bag, Waste Cover, Universal Fluids Kit, Advanced Cleaning Solution (255mL), and Spare Caps. Salient Characteristics for SARS-CoV-2 Testing Supplies Reagents must be compatible for use with the Hologic Panther 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 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: SARS-CoV-2 Assay Controls (pos/neg), Multi-Tube Unit Kits, Waste Bag, Waste Cover, Universal Fluids Kit, Advanced Cleaning Solution (255mL). Salient Characteristics for Tips Tips [liquid hanging (LiHa), 1000 microliter, filtered, conductive and disposable], must be compatible for use with the Hologic Panther Analyzer. Salient Characteristics for Mycoplasma Testing Supplies Reagents must be compatible for use with the Hologic Panther Analyzer. Reagents must be capable of in vitro nucleic acid amplification test (NAAT) for the qualitative detection of ribosomal RNA (rRNA) from Mycoplasma genitalium. Reagents must be intended for use as an aid in the diagnosis of M. genitalium urogenital infections in male and female patients suspected of M. genitalium infection using the Hologic 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 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 be included at no additional cost to complete each test include: Mycoplasma genitalium Controls Kit (pos/neg), Multi-Tube Unit Kits, Waste Bag, Waste Cover, Universal Fluids Kit, and Advanced Cleaning Solution (255mL). Salient Characteristics for BV Testing Supplies Reagents must be compatible for use with the Hologic Panther Analyzer. Reagents must be capable of in vitro nucleic acid amplification test that utilizes real time transcription-mediated amplification (TMA) for detection and quantitation of ribosomal RNA from bacteria associated with bacterial vaginosis (BV), including Lactobacillus (L. gasseri, L. crispatus, and L. jensenii), Gardnerella vaginalis, and Atopobium vaginae using the Hologic 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 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 be included at no additional cost to complete each test include: BV Controls Kit (pos/neg), Multi-Tube Unit Kits, Waste Bag, Waste Cover, Universal Fluids Kit, and Advanced Cleaning Solution (255mL). Salient Characteristics for CV/TV Testing Supplies Reagents must be compatible for use with the Hologic Panther Analyzer. Reagents must be capable of in vitro nucleic acid amplification test for the detection of RNA from microorganisms associated with vulvovaginal candidiasis and trichomoniasis using the Hologic 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 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 be included at no additional cost to complete each test include: CV/TV Controls Kit (pos/neg), Multi-Tube Unit Kits, Waste Bag, Waste Cover, Universal Fluids Kit, and Advanced Cleaning Solution (255mL). Salient Characteristics for HPV Testing Supplies Reagents must be compatible for use with the Hologic Panther Analyzer. Reagents must be capable of in vitro nucleic acid amplification test for the qualitative detection of E6/E7 viral messenger RNA (mRNA) from 14 high-risk types of human papillomavirus (HPV) in cervical specimens. The high-risk HPV types detected by the assay include: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68. The HPV assay does not discriminate between the 14 high-risk types. Cervical specimens in ThinPrep PapTest vials containing PreservCyt Solution and collected with broom-type or cytobrush/spatula collection devices may be tested with the HPV assay. The assay is used with the Hologic 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 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 be included at no additional cost to complete each test include: HPV Controls Kit (pos/neg), Multi-Tube Unit Kits, Waste Bag, Waste Cover, Universal Fluids Kit, and Advanced Cleaning Solution (255mL). Salient Characteristics for HPV 16 18/45 Testing Supplies Reagents must be compatible for use with the Hologic Panther Analyzer. Reagents must be capable of in vitro nucleic acid amplification test for the qualitative detection of E6/E7 viral messenger RNA (mRNA) of human papillomavirus (HPV) types 16, 18, and 45 in cervical specimens from women with HPV assay positive results. The HPV 16 18/45 genotype assay can differentiate HPV 16 from HPV 18 and HPV45, but does not differentiate between HPV 18 and HPV 45. Cervical specimens in ThinPrepPap Test vials containing PreservCyt Solution and collected with broom-type or cytobrush/spatula collection devices may be tested with the HPV 16 18/45 genotype assay. The assay is used with the using the Hologic 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 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 be included at no additional cost to complete each test include: HPV 16 18/45 Controls Kit (pos/neg), Multi-Tube Unit Kits, Waste Bag, Waste Cover, Universal Fluids Kit, and Advanced Cleaning Solution (255mL). (End of Salient Characteristics) FACTOR 2 - PRICE: The quoter shall ensure to provide the quoted prices on the SF 1449 and be in compliance with the following: (1) The quoter shall provide a unit price and extended amount (i.e., quantity multiplied by unit price) shall be submitted for each Contract Line Item Number (CLIN). In case of in case of a discrepancy, the unit price will take precedence. (2) The quoter shall limit their prices to two decimal places (example: $/3.45). ACQUISITION PROCEDURE This is a commercial item under FAR Part 12 and the acquisition procedures to be used for this purchase will be in accordance with FAR Part 13.5, Simplified Procedures for Certain Commercial Products and Commercial Services. SPECIAL NOTE: Offerors and quoters are required to be registered in the System for Award Management (SAM) at the time an offer or quote is submitted and lack of registration will make an offer or quote ineligible for award. Vendors may obtain information on registration and annual confirmation requirements by calling +1 (555) 000-0000 or via Internet at https://www.sam.gov. Questions & Answers: Question 1: The Government received a question regarding line item CLIN 0007, 1007 and 2007 entitled - HPV Testing Supplies in particular to the example item provided as - 303570 Aptima HPV assay (250-T). The part number 303570 is for - Aptima HPV Assay 100 Tests, but the item description is - Aptima HPV assay (250-T) which is for 250 tests per kit. If the test kit for 250 tests is requested, then part number 303093 would be correct. Please advise which packing size is requested. Answer 1: The Government prefers the test kits with the packing size of 250 but can also utilize the packing size of 100 as long as they are sufficient for a total amount of 3,750 tests. Question 2: The Aptima SARS-CoV-2 Control has a price however this item is included in CLIN 0002 at no charge. How would you like us to list that this item has a price and where would you like us to include this cost? Answer 2: The Government prefers to keep the cost of the SARS-CoV-2 Control within the same line item. Question 3: The tips requested in CLIN 0003 are packaged in a case of 9600. If this is the case, do you still need 100 cases (ea) of 9600 tips? Please let us know the total volume requested and how we can convert to provide an accurate total amount. Answer 3: The Government requires a total quantity of 96,000 tips. It is preferred to receive the signed conformed SF1449 document. Alternatively the original SF1449 can be submitted along with the Amendments (SF30s) if all documents are signed.