Preventive Maintenance for (4) Autoclaves

1. This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued.
2. The solicitation number is FDA-RFQ-25Q1284120. This requirement is issued as Request for Quote (RFQ).

The solicitation is issued as a Full and Open competition.

1. The solicitation documented and incorporated provisions and clauses in effect through the Federal Acquisition Circular (FAC) FAC-2024-07, Effective 08/29/2024.
2. The associated North American Industry Classification System (NAICS) Code is 811310 with a small business size standard of $12.5 million.
3. The US Food & Drug Administration (FDA) intends to issue a Commercial Item Firm Fixed-Price purchase order that meets the requirements herein.

All responsible sources may submit a quote, which if timely received, shall be considered. The quote and any questions submitted shall reference the solicitation number and name.

Quote Due Date & Time:            7 April 2025; 10 AM EST

Question Due Date &Time:        28 Macrch 2025; 10 AM EST

Point(s) of Contacts:   Warren Jackson; warren.jackson@fda.hhs.gov

Period for Acceptance of Quotes: The quoter agrees to hold the prices firm for 90 calendar days after quote due date.

Quotes that do not provide pricing for all line items may be deemed non-responsive.
 

The quoter shall submit all electronic documents for Microsoft Office suite products without the use of “macros”. When submitting proposals via email, DO NOT include .exe, .mso, or any other executable file types that could potentially trigger email security protections (i.e. email blocks, quarantine). If the offeror or applicant submits documents that contain macros, macro referenced files, and/or executable files, the Government will not be able to view or open such documents and the submission will be considered non-responsive to the solicitation. No additional time will be given to an quoter to correct the document submission and the Government will not inform the quoter that their submission is non-responsive prior to award. It is the quoter’s responsibility to ensure all electronic documents are submitted without the use of macros.

1. QUOTE SUBMISSION INSTRUCTIONS

The quoter shall submit all quotes to the point(s) of contact listed by the due date and time indicated in the solicitation. Discounts are requested from the established GSA schedule prices.

All quotes shall be submitted with the following.

a) Pricing for all line items with the total price

b) Quote issue date and expiration date

c) Autoclave serial numbers and type

d) The information requested under section x of this solicitation.

A list of line-item number(s) and items, quantities, and/or units of measure (including option(s), as applicable) can be found in sections iv of the solicitation.

1. BASIS OF AWARD

The Government will award a contract resulting from this solicitation to the responsible quoter whose quote meets the requirements listed under this solicitation and is the lowest priced quote received in response to this solicitation. Therefore, award will be made to quoter whose quote is determined to be Lowest Price Technically Acceptable.

A written notice of award or acceptance of an offer furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer’s specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

1. DESCRIPTION OF REQUIREMENT

   1. Background

The U.S. Food and Drug Administration’s (FDA) Seattle Human and Animal Food Laboratory (SEAHAFL) is an ISO 17025 accredited regulatory food testing laboratory. Autoclaves/sterilizers are required for sterilization of media and decontamination of microbiological waste generated in processing of regulatory samples. Bi-annual maintenance (PM) of autoclaves is required under this ISO 17025 certification.

1. 1. Scope

SEAHAFL requires services from a trained vendor capable of providing service support plans that cover routine maintenance and repair of four (4) autoclaves (3 Steris, 1 Fisher) located at SEAHAFL, in Bothell, WA. The equipment is not currently under warranty coverage.

The following instruments require maintenance (4 autoclaves): See table below for details:

               Model                     Serial number     Location     Date started

AMSCO-Century SV-148H        0327912-01         139                02/26/2013

AMSCO-Century SV-148H        0307913-15          139                12/29/2014

ST75925 Thermo Fisher         1277020428103      139                12/01/2011

AMSCO-Lab 250                       LV0329912-26       141                03/25/2013

At a minimum, the preventative maintenance support plan shall cover labor and travel, biannual scheduled visits per year per instrument, and priority status for technical emergency support inquiries.

1. 1. Requirement

Minimum Performance Requirements

Through the service agreement, the Vendor shall be responsible for the following:

• Providing SEAHAFL users with direct telephone technical support, with access to trained individuals for both software and equipment.

• On-site technical support within 5 business days of the initial trouble if a solution acceptable to the FDA cannot be reached over the phone.

• The equipment portion of the service agreement shall include a minimum of two on-site Preventative Maintenance visits per year per instrument which shall meet the following requirements:
  • Equipment maintenance work is performed by a trained vendor. This trained vendor shall provide/possess:
    1. Telephone Support
    2. Proper training and licensure to work in the State of Washington
    3. Be able to respond within 5 working days.
    4. Shall not use salvaged parts from other instruments for performing maintenance and repairs. Vendor shall specify parts required for repairs or maintenance are included in the quotation provided (or a separate quotation). All parts used in PM and repairs must be guaranteed to meet OEM quality standard for performance.

• • Labor, and travel/per-diem costs for PM and repairs to the SEAHAFL shall be included in the price of the service agreement.

Records and Reports

The Vendor shall, commensurate with the completion of each service call , provide the end-user of the equipment with a copy of a field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced/repaired and detailing the reason for the service call, a detailed description of the work performed, a list of any reference test instruments or other equipment used to affect the repair or otherwise perform the service, the name(s) and contact information of the technician who performed the repair/service, and for information purposes, the on-site hours expended and parts/components replaced.

1. 1. INSPECTION/ACCEPTANCE CRITERIA

Inspection and acceptance shall be in accordance with the base clause 52.212-4(a). Contracting officer’s representative (COR) is responsible for the inspection and acceptance of the deliverables for this requirement.

1. 1.  CONTRACT TYPE

This is firm fixed price.

1. 1.  PERIOD OF PERFORMANCE

The estimated period of performance (POP) is for a base year with four (4) option years.

Base Period:    04/20/2025 – 04/19/2026

Option Year 1: 04/20/2026 – 04/19/2027

Option Year 2: 04/20/2027 – 04/19/2028

Option Year 3: 04/20/2028 – 04/19/2029

Option Year 4: 04/20/2029 – 04/19/2030

1. 1.  PLACE OF DELIVERY AND PERFORMANCE

FDA/SEAHAFL

22201 23rd Dr. SE

Bothell, WA 98021

POC: Will be identified at time of award.