Molecular Diagnostics Analyzers and Reagents

AMENDMENT 0003: The purpose of this amendment is to provide a response to a question received by the Contracting Office.

Question #6: Newer methodologies have been approved by the FDA and are now commonly used in the industry. Is the government open to accepting responses from vendors that offer these newer methodologies but whose specifications vary from the Statement of Work's minimum requirements?

Response #6: Yes, vendors may submit their proposals in accordance with the combined synopsis/solicitation. Proposals will be evaluated for technical acceptability, in accordance with the evaluation factors outlined in the combined synopsis/solicitation.

AMENDMENT 0002: The purpose of this amendment is to provide a response to a question received by the Contracting Office.

Question #5: 5.3.6 Must be 120 volage. Will a higher voltage requirement be expected? If the specification be updated to except a higher voltage? Our equipment required voltage is 200 to 240 VAC?

Response #5: No, the voltage will remain 120 voltage as they are standard outlets.

AMENDMENT 0001: The purpose of this amendment is to provide responses to questions received by the Contracting Office and to update paragraph 1.2 of the Statement of Work and to delete paragraphs 5.3.12 and 5.3.26 of the Statement of Work. See Solicitation W81K0224Q0043_Amendment 0001withAttach1 in SAM.gov. Please submit any questions regarding the solicitation within 10 days before the closing of the solicitation. The due date for receipt of quotations remains unchanged. Responses to questions received by the contracting office:

Question #1: Is their a deadline for vendors to ask clarifying questions? If yes, can you please provide the deadline?

Response #1: Yes, please submit any questions by 10 days before the solicitation closes.

Question #2: Can you please clarify what low risk genotypes the question 5.3.12 is referring to?

Response #2: See revised Statement of Work in W81K0224Q0043_AMD01 with Attach1, which removes 5.3.12.

Question #3: 5.3.5 list vendors must be able to direct load Thin Prep vials or have a pre-analytical device that eliminates the need to manually aliquot. 5.3.26 states the system must be able to accept primary specimen containers Are these two referring to the same thing? Does primary specimen container refer to Thin Prep vial or the aliquoted sample container?

Response #3: See revised Statement of Work in W81K0224Q0043_AMD01 with Attach1, which removes 5.3.26.

Question #4: In Section 1.2 under the statement of work, the RFQ states, "The Contractor shall also provide maintenance and service support of the molecular analyzer to include:

complete replacement if deemed necessary, repair parts, Information technology hardware, software, and labor to keep the unit operational to manufacturer’s specifications seven (7) days per week, twenty-four (24) hours, excluding federal holidays." Our current understanding of Madigan Army’s HPV operation is that they operate Monday-Friday. I would appreciate the clarification.

Response #4: See revised Statement of work, which amends 1.2.

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, 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.

Medical Readiness Contracting Office – Pacific intends to solicit, negotiate, if necessary, and award a Firm Fixed Price Contract for a cost per test for molecular diagnostics analyzers and reagents capable of running multiplex testing for qualitative detection and genotyping of the DNA of Human Papilloma Virus (HPV) at Madigan Army Medical Center (MAMC), Washington. This is a request for quotation (RFQ). This solicitation number is W81K0224Q0043.

The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2024-01. The Standard Industrial Classification Code is 6515, size standard is 1,250 employees and the NAICS is 325413. This is NOT a Small Business Set-Aside. Provision at 52.212-1, Instructions to Offerors – Commercial, and its addendum applies to this acquisition and a statement regarding any addenda to the provision.

See W81K0224Q0043Att1 Provision at 52.212-2 – Commercial Items and its addendum applies to this acquisition. See W81K0224Q0043Att1. Offerors shall include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications – Commercial Items, with its offer. The clause at 52.212-4 Contract Terms and Conditions -- Commercial Items, and its addendum applies to this acquisition. See W81K0224Q0043Att1.

The deviation to clause at 52.212-5, Contract Terms and Conditions Required to Implement Statues of Executive Orders – Commercial Items, applies to this acquisition. See W81K0224Q0043 for the FAR clauses that are applicable to this. The Defense Priorities and Allocation System (DPAS) and assigned rating is not applicable. The Government intends to award a firm fixed-price type contract for a base period of 01 Oct 2024 through 30 September 2025 with four (4) one-year options to the successful quoter.

Contract Requirements – The successful quoter shall be required to provide the cost per test for molecular diagnostic analyzer and reagents capable of running multiplex testing for qualitative detection and genotyping of HPV, with the minimum requirements given in the attachment W81K0224Q0043Att1. Contractors shall quote their unit pricing based on the estimated quantities identified in each Contract Line Item Number.

Point of contact for this solicitation is Leslie Takayama, email: leslie.m.takayama.civ@health.mil Responses must be received by: 12 July 2024 @ 10:00 AM HST. **SEE ATTACHMENT W81K0224Q0043Att1 FOR DELIVERY AND ACCEPTANCE, CONTRACT LINE ITEMS, AND TERMS AND CONDITIONS