Combined Sysnobis solicitation EEG.doc

This is a combined synopsis/solicitation for commercial items prepared in accordance with FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation, and a written solicitation will not be issued. The Request for Quote number is HT940624R0016. Offers are due not later than 2:00 P.M. EST on 15 April 2024. Provisions and clauses in effect through Federal Acquisition Circular 2024-03 are incorporated. NAICS code for this acquisition is 334510. Small Business size standard is 1,250 employees. This requirement is a 100% Small Business set-aside and only qualified offerors may submit offers. Per FAR 4.1101 Offerors are required to be registered in SAM at the time an offer or quotation is submitted in order to comply with the annual representations and certifications requirements. The Defense Health Agency will award a purchase order, for two (2) full featured electroencephalogram (EEG) system on behalf of the 633rd Medical Group, Langley AFB, VA. resulting from this synopsis/solicitation to the responsible contractor whose quote conforming to the solicitation will be more advantageous to the Government, price and other factors considered. Any small business who understands their product meets this specification are may submit an offer.

The FAR provision at 52.212-1, Instructions to Offerors Commercial, applies to this acquisition including attached addenda to the provision. The FAR provision at 52.212-2, Evaluation -- Commercial Items, and the specific evaluation criteria as attached addenda also apply to this acquisition. The Offeror is to include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications -- Commercial Items, with its offer. Clause at 52.212-4, Contract Terms and Conditions -- Commercial Items, applies to this acquisition and a statement regarding any addenda to the clause. Addendum is attached. Clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Items, applies to this acquisition and a statement regarding which, if any, of the additional FAR clauses cited in the clause are applicable to the acquisition.

Regulatory Requirements:

The EEG and all of its components shall be approved by the Food and Drug Administration (FDA) to market and deliver medical products for use in the United States of America. The claims made for the product shall comply with the regulations of the FDA with respect to products for marketing and delivery of a medical product for use in the United States of America.

Essential Characteristics: The Defense Health Agency has a requirement for two (2) full featured electroencephalogram (EEG) systems, with capabilities including video and audio recording. The EEG system needs to have a 32 channel Amplifier on an A3 cart. The EEG shall support neurological testing that evaluates cerebral function, clinical and sub-clinical seizure as well as other underlying neurological conditions and diseases. The system shall have 32 channels for collecting brainwave EEG data on adults, pediatric and neonates. The system shall be a standalone system. Desktop install of Word required for reporting. The power requirement for the EEG is 120-volt outlet.

32 channel, with 7 active reference pairs, four DC, SpO2, CO2 Connectors

Current Model Amplifier

Full Motion Digital Video with post record zoom/pan

Tilt Synchronized to 100 ms with EEG

Standard Software Capabilities

Eight Channels of CSA and EKG Artifact Filter

Adult Seizure Detection

Voltage Mapping

EEG Central Monitoring

Mobile Cart

Telescope pole for video and audio recording

Photic stimulator range 1-60 HZ

Patient event button capabilities

Review and monitor live data simultaneously.

Remote input box

Auto archiving data

Vendor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor, or authorized reseller for the proposed equipment/system, such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty, and service associated with the equipment/system shall be in accordance with the OEM terms and conditions.

Evaluation Factors for Award: The Government intends to award a contract resulting from this solicitation to the responsible offeror whose offer is the Best Value in accordance with FAR 15.101-1, cost and other factors considered. The technical factors, factors 1, is significantly more important than price, and are listed in descending order of importance. However, price may become a critical factor in the event that two or more offerors are determined to be essentially equal following the evaluation of technical factor. Evaluation of price will be based on the offeror’s total price for all line items as delivered to Hampton, VA.

Technical offers must include sufficiently detailed information to enable evaluation based on the three (3) factors listed below in order of decreasing priority:

1. Technical

a. Conformance to Essential Characteristics

b. Design, Quality and Capability

2. Price

Conformance to Essential Characteristics – Evaluation shall include ability to meet the essential characteristics of this requirement. Vendors not meeting all requirements will not be further considered for award unless there are no other technically acceptable offerors.

Design Quality and Capability – The Government will evaluate the design, quality and capabilities of the proposed EEG system.

The Government reserves the right to consider other past performance information at its disposal, in addition to any information obtained from the references provided above. The Government is likely to randomly select references provided for contact and does not commit to contact every reference.

INSTRUCTIONS TO OFFEROR

Offerors must submit an offer that is legible and comprehensive enough to provide the basis for a sound evaluation by the Government. Information provided shall be precise, factual, and complete. Legibility, clarity, completeness, and responsiveness are of the utmost importance. Offers shall be in the form prescribed by, and shall contain a response to, each of the areas identified. Any offer which does not provide, as a minimum, that which is required in this solicitation may be determined to be substantially incomplete and not warrant any further consideration. A complete offer including Technical, and Price, shall be submitted by the closing date specified in the solicitation.

TECHNICAL OFFER INSTRUCTIONS

Offerors shall provide sufficient technical documentation to allow for thorough evaluation of offer. Additionally, the vendor shall fully explain their ability to meet the requirements.

Page limit for technical offer: 30 pages

PRICE OFFER INSTRUCTIONS

Offeror shall specify the Total Price. Shipping shall be FOB destination. Offers will be evaluated to ensure reasonableness and completeness. The government anticipates award of a Firm Fixed Price contract. Offerors shall submit firm-fixed pricing for all above requirements. Include commercial price lists and if applicable, any FSS schedule numbers and pricing. Include any applicable discounts to the Government.

Page Limit for pricing offer: 5 pages

Other Administrative instructions:

The vendor shall provide company details, specifically:

Complete company name and address:

e-mail address:

Phone Number:

Current and valid Tax Identification Number (TIN):

Current and valid CAGE Code:

Current and valid Unique Entity ID:

Submission of Offer

Only email offers will be accepted. (Email can be no larger than 5 Megs, multiple emails will be accepted) Email offer proposal as attachment to Jan Harding at jan.t.harding.civ@health.mil. No paper proposals will be accepted. offers are due not later than 2:00 P.M. EST on 15 April 2024. Any questions must be addressed to Jan Harding, by email only, NLT 1200 on 8 April 2024. No phone calls accepted.

The following FAR provisions and clauses are applicable to this procurement:

52.212-1 Instructions to Offerors-Commercial Products and Commercial Services.

2023-09

52.212-2 Evaluation-Commercial Products and Commercial Services

2021-11

52.212-3 Offeror Representations and Certifications-Commercial Products and

Commercial Services

2023-11

52.212-4 Contract Terms and Conditions-Commercial Products and Commercial Services.

2023-11

52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders – Commercial Items

2024-02 52.204-7 System for Award Management.

2018-10

52.204-23 Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities 2023-12

52.209-10 Prohibition on Contracting with Inverted Domestic Corporations 2015-11 52.204-10 Reporting Executive Compensation and First-Tier Subcontract Awards 2018-10

52.209-6 Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment.

2015-10

52.219-6 Notice of Total Small Business Set Aside

2020-11

52.222-3 Convict Labor

2003-06 52.222-19 Child Labor-Cooperation with Authorities and Remedies

2018-12 52.222-21 Prohibition of Segregated Facilities

2015-04 52.222-26 Equal Opportunity

2016-09 52.222-35 Equal Opportunity for Veterans

2020-06 52.222-36 Equal Opportunity for Workers with Disabilities

52.222-37 Employment Reports on Veterans

52.222-40 Notification of Employee Rights Under the National Labor Relations Act

2010-12

52.222-50 Combating Trafficking in Persons

2021-11 52.223-11 Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons

2016-06 52.223-18 Encouraging Contractor Policies to Ban Text Messaging While Driving 2020-06 52.239-1 Privacy or Security Safeguards

1996-08 The following DFAR provisions and clauses are applicable to this procurement:

252.203-7000 Requirements Relating to Compensation of Former DoD Officials.

2011-09

252.203-7002 Requirement to Inform Employees of Whistleblower Rights.

2022-12

252.203-7005 Representation Relating to Compensation of Former DoD Officials.

2022-09

252.204-7015 Notice of Authorized Disclosure of Information for Litigation Support.

2023-01

252.204-7016 Covered Defense Telecommunications Equipment or

Services- Representation.

2019-12

252.204-7017 Prohibition on the Acquisition of Covered Defense Telecommunications

Equipment or Services-Representation.

2021-05

252.204-7018 Prohibition on the Acquisition of Covered Defense Telecommunications

Equipment or Services.

2023-01

252.204-7024 Notice on the Use of the Supplier Performance Risk System.

2023-03

252.211-7008 Use of Government-Assigned Serial Numbers.

2010-09

252.211-7003 Item Unique Identification and Valuation.

252.223-7008 Prohibition of Hexavalent Chromium.

252.225-7000 Buy American--Balance of Payments Program Certificate.

2014-11

252.225-7001 Buy American and Balance of Payments Program.

252.225-7002 Qualifying Country Sources as Subcontractors.

2022-03

252.225-7012 Preference for Certain Domestic Commodities.

2022-04

252.225-7031 Secondary Arab Boycott of Israel.

2005-06

252.225-7050 Disclosure of Ownership or Control by the Government of a Country that is a State Sponsor of Terrorism.

2022-12

252.225-7055 Representation Regarding Business Operations with the Maduro Regime. 2022-05

252.225-7056 Prohibition Regarding Business Operations with the Maduro Regime.

2023-01

252.225-7059 Prohibition

252.225-7060 Prohibition on Certain Procurements from the Xinjiang Uyghur

Autonomous Region.

2023-06

252.232-7003 Electronic Submission of Payment Requests and Receiving Reports.

2018-12

252.232-7006 Wide Area Workflow Payment Instructions

2023 -01

252.232-7010 Levies on Contract Payments.

2006-12

252.244-7000 Subcontracts for Commercial Products or Commercial Services.

2023-11

252.246-7008 Sources of Electronic Parts.