Installation for a Commercial-Off-The-Shelf (COTS) Radiography X-ray Retrofit

The purpose of Amendment 0001 is to incorporate Question and Answers. See attachment 6973GH-24-Q-00147/0001 I. Questions and Answers dated May 6, 2024, is hereby incorporated as follows: Question 1: There is a section that requires both a FAT (Factory Acceptance Testing) and SAT (Site Acceptance Testing) program be developed and submitted. This can take many different forms, but all require a substantial amount of resources, so I need to understand the expectation in more detail. FAA Response: In doing some research, I found the FDA requirements for X-Ray emitting manufacturers.Rather than having to generate new documentation, the requirement is satisfied if they can provide the documentation showing that they are in compliance with the FDA requirements: The FDA regulates manufacturers of X-ray imaging devices through the Electronic Product Radiation Control (EPRC) and the medical device provisions of the Federal Food, Drug, and Cosmetic (FD&C) Act. FDA specifies requirements related to these provisions through "regulations" or "rules," which are mandatory, and it makes related recommendations through issuance of "guidance(s)," which are not mandatory. Electronic Product Radiation Control (EPRC) requirements for manufacturers and assemblers Manufacturers and assemblers of electronic radiation-emitting products sold in the United States are responsible for compliance with the radiological health regulations found in Title 21 of the Code of Federal Regulations (Subchapter J, Radiological Health). Here's the full link: https://www.fda.gov/radiation-emitting-products/me dical-imaging/medical-x-ray-imaging Question 2: I am verifying the Requirements for this RFO that the Detectors (hardware) be manufactured in the USA or TAA compliant? FAA Response: The Buy American Act (BAA) applies to any procurement of a supply that is over the Micro Purchase Threshold (MPT), which is currently $10,000, and can reasonably be procured as Made in US compliant. The Trade Agreements Act (TAA) applies to government contracts valued above the TAA threshold, which is currently $183,000 for a supply contract. Our market research places this procurement firmly above the MPT but below the TAA and has a reasonable expectation that a company can provide a Made in US compliant solution. Therefore the TAA rules do not apply. II. All other Terms and conditions Remain unchanged, Proposals must be received by the FAA Contract Specialist, contact@example.gov, no later than 3:00P.M. CT Monday, May 13, 2024. The Federal Aviation Administration (FAA) Civil Aerospace Medical Institute (CAMI) Occupational Medicine Health Clinic Division (AAM-700) requires a Firm Fixed Price (FFP) and installation for a Commercial-Off-The-Shelf (COTS) Radiography X-ray Retrofit. AAM-700 has initiated this new request for Delivery and Installation of the following equipment: Digital Radiography (DR) Detector retrofit to current radiology room. Windows 10 operating system-based workstation with operating software. The FAA CAMI Occupational Health Clinic is looking to acquire a DR radiology retrofit for x-ray room. The clinic's current radiology equipment is malfunctioning and outdated and needs upgrading. Because of this, the CAMI Occupational health clinic is looking to acquire a new x ray processor and scanner. It will allow the clinic to decrease the exposure of patients during x-rays, decrease time taken while processing and sending to the image to outside radiology reading service. This will speed up patient wait times and return them to work faster. The current CR system will be excessed by the source that is installing the new DR system Please read the attached RFQ in its entirety and all other Attachments including the Statement of Work. This effort will acquire a radiography x-ray retrofit DR detector and workstation. All equipment delivered must be new, manufactured in the USA, and installed by the vendor. The FAA will not pay for any information received or costs incurred in preparing the response to the RFQ; and Any costs associated with the announcement submittal is solely at the interested vendor's expense. Any questions or concerns pertaining to this RFQ or the requirement within should be sent in writing to the contract specialist contact@example.gov. All questions must be received by 3:00 p.m. CT on Tuesday April 25, 2024, to ensure adequate response time. The offeror's Cost/Price Proposal shall include the following information: (1) Section A, REQUEST FOR QUOTATIONS, Blocks 12-14 RFQ 6973GH-24-Q-00147 (2) Section B, Supplies or Services and Prices/Costs (3) Relevant fill-in clauses contained in Terms and Conditions Pages 2-34 (Note: Completion of documents identified at (1) through (3) above indicates that the Offeror has read and agrees to the terms and conditions contained in the RFQ. Contractors must be registered with the System for Award Management, www.sam.gov on the date established for receipt of offers, 3:00 p.m. CT on Monday May 13, 2024. Reference AMS Clause 3.3.1-33, paragraph (d), - if the offeror does not become registered in the SAM database in the time prescribed by the Contracting Officer, the Contracting Officer may proceed to award to the next otherwise successful registered Offeror. The name and address of your firm on the proposal MUST EXACTLY MATCH the address used for your UEI/SAM registration. Proposals must be received by 3:00 pm Central (Oklahoma Time) Monday May 13, 2024.