6530--Cardiac Stimulator and Maintenance Small Business Set-Aside

Request for Quote (RFQ) #: 36C25923Q0584

Cardiac Stimulator

Small Business Set Aside

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 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. The Government reserves the right to make no award from this solicitation.

* The deadline for all questions is 4:00pm MT, 6/19/2023

All questions must be submitted in writing no later than the question cut-off date marked above. All questions will be answered officially through an amendment to the solicitation.

** Quotes are to be provided to Jeremy.ferrer@va.gov no later than 4:00pm ET, 4/21/2023.

Quotes shall not be hand carried. Faxed quotes shall not be accepted. Emailed quotes are the only method of submitted quotes (4MB email limit). The Government reserves the right to make award solely on initial Quotes received. Offerors bear the burden of ensuring that all portions of the offer (and any authorized amendments) reach the designated office before the deadline specified in the solicitation. This RFQ shall be completed in its entirety, and signed and dated, failure shall not be considered for award.

This is a Request for Quote (RFQ) and the solicitation number is 36C25923Q0584. The government anticipates awarding a firm-fixed price contract resulting from this solicitation.

This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2023-04 effective June 2, 2023.

The North American Industrial Classification System (NAICS) code for this procurement is 334510 with a small business size standard of 1,000 employees. This solicitation is a 100% set-aside for Small Businesses.

List of Line Items;

Line Item

Description

Quantity

Unit of Measure

Unit Price

Total Price

0001

Bloom2 Stimulator System

1

EA

$

$

0002

Bloom2 Tactile Operator Unit

1

EA

0003

Bloom2 Graphical Console

1

EA

0004

Bloom2 Stim Unit

1

EA

0005

Kit Installation

1

EA

0006

On-Site Bloom2 Training

1

EA

0007

(1) Year Warranty Includes Parts & Labor

1

EA

0008

OY1 Bloom Service Agreement; includes (1) annual Preventative Maintenance; bloom loaner, replacement parts

1

EA

0009

OY2 Bloom Service Agreement; includes (1) annual Preventative Maintenance; bloom loaner, replacement parts

1

EA

0010

OY3 Bloom Service Agreement; includes (1) annual Preventative Maintenance; bloom loaner, replacement parts

1

EA

0011

OY4 Bloom Service Agreement; includes (1) annual Preventative Maintenance; bloom loaner, replacement parts

1

EA

Grand Total

$

Description of Requirements for the items to be acquired:

Salient Characteristics - (Brand name or equal. Fischer Medical s Bloom2 System is the basis of design for these characteristics)

Cardiac Stimulator and Recorder

Standard (1) Year Manufacturer s Warranty

On-Site Training

Cardiac signal waveform display

Error messages with clear text explanation

Ability to save multiple preferred pre-protocol setups that can be recalled at touch of a button

Touch Screen Display

Built in battery backup and emergency pace function

Buttons on keyboard to increment and decrement by touch and sound

Four channel pacing at 25 mA

Graphical Console

Tactile Operator Unit

Stim unit

Customized, pre-programmed protocol set-up with ability to instantly adjust settings based on clinical need

Ability to provide unrestricted instant burst pacing

Actual cardiac signal readback displayed waveforms on any pacing catheter (not manufacturer specific)

Four channel pacing drives that can withstand ablation and cardioversion pulses that can be independently programmed

Ethernet connection with other EP equipment

No menu drill-down

Small footprint (requires minimal counter space)

No keyboard or mouse

Upgradable firmware for pacing drives and controls for future improvements

Power Source: 100V - 240V, 50Hz 60Hz

Power supplies and motors meet UL60601-1; CAN-CSA C22.2 No. 601.1

Scope of Work:

Equipment will be shipped in original OEM packaging and will be inspected upon receipt to ensure equipment is free of defect and/or damage. The equipment will ship complete, no partial shipments will be accepted.

Date of manufacture must not be greater than 2 years before the purchase order date. The equipment must not be used or refurbished and must have the latest manufacturer s software/hardware updates installed. Any batteries provided with the unit will not be manufactured more than 12 months before the purchase order issue date.

The vendor will provide all applicable service manuals that includes theory of operation, maintenance requirements, repair information, schematics, part lists and troubleshooting information in electronic format for use by the VA Biomedical Engineering Department.

Training:

The price quoted shall include contractor responsibility for providing on-site orientation and training of using personnel in operation and care of the equipment furnished. This training shall include actual demonstration and operation of the equipment, preventative maintenance, and any adjustments or other actions which may be undertaken by operating personnel in the event of failure of equipment, provided that such adjustment or action shall in no way jeopardize the Government's rights under contract guarantee clause. Upon delivery, this training shall be given by qualified contractor representatives on a date to be determined by the using service POC.

Vendor shall submit training materials and training videos (prepared in CD or DVD format) on each piece of equipment for operation and maintenance. Any available training videos shall be for operation and maintenance and shall not be combined. These training materials and videos shall demonstrate the operation and maintenance of the equipment and any adjustments or other actions that may be undertaken by VA operating personnel in the event of failure of equipment. These training materials and videos shall be submitted to the responsible operations official or his designee prior to beginning of training.

The Vendor shall consult with the Point of Contact or person acting in that capacity regarding the time this training will begin. These officials will be responsible for arranging for the presence of personnel to be trained.

Delivery and acceptance is to be F.O.B Destination (FAR 52.247-34) at the Veterans Affairs Medical Center, located at:

Department of Veterans Affairs

Eastern Colorado VA Health Care System

Rocky Mountain Regional VA Medical Center

1700 N. Wheeling Street

Aurora, CO 80045

52.212-1, Instructions to Offerors--Commercial Items applies to this acquisition

ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS COMMERCIAL

Gray market items are Original Equipment Manufacturer s (OEM) goods sold through unauthorized channels in direct competition with authorized distributors. This procurement is for new OEM medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e. replacement parts) for VA Medical Centers. No remanufactures or gray market items will be acceptable.

Offeror shall be an OEM, authorized dealer, authorized distributor or authorized reseller for the proposed medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e. replacement parts), verified by an authorization letter or other documents from the OEM, such that the OEM s warranty and service are provided and maintained by the OEM. All software licensing, warranty and service associated with the medical supplies, medical equipment and/or services contracts for maintenance of medical equipment shall be in accordance with the OEM terms and conditions.

The delivery of gray market items to the VA in the fulfillment of an order/award constitutes a breach of contract. Accordingly, the VA reserves the right enforce any of its contractual remedies. This includes termination of the contract or, solely at the VA s election, allowing the Vendor to replace, at no cost to the Government, any remanufactured or gray market item(s) delivered to a VA medical facility upon discovery of such items.

Offerors providing an or equal product(s) must adhere to the terms in FAR 52.211-6. If an item in this solicitation is identified as brand name or equal, the purchase description reflects the characteristics and level of quality that will satisfy the Government s needs. The salient physical, functional, or performance characteristics that equal products must meet or exceed are specified in the solicitation. To be considered for award, offers of equal products, including equal products of the brand name manufacturer, must

Meet the salient physical, functional, or performance characteristic specified in this solicitation;

Clearly identify the item by-

Brand name, if any and

Make or model number,

Include descriptive literature such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the Contracting Officer; and

Clearly describe any modification the offeror plans to make in a product to make it conform to the solicitation requirements. Mark any descriptive material to clearly show the modification.

The contracting officer will evaluate equal products on the basis of information furnished by the offeror or identified in the offer and reasonably available to the contracting officer. The Contracting Officer is not responsible for locating or obtaining any information not identified in the offer. Unless the offeror clearly indicates in its offer that the product being offered is an equal product, the offeror shall provide the brand name product referenced in the solicitation

Any award made as a result of this solicitation will be made on an All or Nothing Basis.

State if quoted items are available and priced through offerors existing Government-wide Acquisition Contract (GWAC), GSA Multiple Award Schedule (MAS) contract, or VA-wide Acquisition Contract.

If the acquisition is set-aside for SDVOSBs/VOSBs, their socioeconomic status must be VIP verified and visible in the VA Vendor Information Pages (VIP): https://www.vip.vetbiz.gov/ at the time of quote submission AND award, or will be considered non-responsive, and will NOT be considered for award.

Offerors are warned against contacting any VA personnel other than the Contracting Officer and Contract Specialist prior to placement of any award made resulting from this RFQ. If such contact occurs and found to be prejudicial to competing contactors, the offeror making such contact may be excluded from award considerations.

All proprietary information shall be clearly and properly marked. If the Offeror submits annexes, documentation, attachments or the like, not specifically required by this solicitation, such will count against the Offeror s page limitations unless otherwise indicated in the specific volume instructions below.

All information shall be confined to the appropriate file. The offeror shall confine submissions to essential matters, sufficient to define the quote and provide an adequate basis for evaluation. Offerors are responsible for including sufficient details, in a concise manner, to permit a complete and accurate evaluation of each quote.

Submission of quote shall include the following volumes: (I) Technical capability or quality of the item offered to meet the Government requirement

Volume I - Technical capability or quality of the item offered to meet the Government requirement

The offeror shall submit specifications, cut sheets, or brochures confirming the equal products, including equal products of the brand name manufacturer submitted, meets or exceeds the salient physical, functional, or performance characteristic specified in this solicitation. The product(s) quoted must be identified by brand name, if any, and make or model number.

Volume II Price

Price - The offeror shall complete the pricing schedule provided in Section (v) above: Price/Cost Schedule.

(End of Addendum to 52.212-1)

52.212-2, Evaluation--Commercial Items applies to this acquisition

ADDENDUM to FAR 52.212-2 EVALUATION COMMERCIAL ITEMS:

The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government considering price and other factors.

The following factors shall be used to evaluate quotations:

Factor 1. Technical capability or quality of the item offered to meet the Government requirement

Factor 2. Price

Evaluation Approach. The Government will evaluate quotations using the comparative evaluation process outlined in FAR 13.106-2(b)(3), where quotations will be compared to one another to determine which provides the best benefit to the Government. The Government reserves the right to consider a quotation other than the lowest price that provides additional benefit(s). Quotations may exceed minimum requirements of the solicitation. The Government reserves the right to select a quotation that provides benefit to the Government that exceeds the minimum requirements of the solicitation, but is not required to do so. Each response must meet the minimum requirements of the solicitation. The Government is not requesting or accepting alternate quotations. The evaluation will consider the following:

Factor 1. Technical capability or quality of the item offered to meet the Government requirement: The quotation will be evaluated to the extent to which it can meet and/or exceed the Government s requirements as outlined in the solicitation and based on the information requested in the instructions to quoters section of the solicitation.

Factor 2. Price: The Government will evaluate the price by adding the total of all line item prices, including all options. The Government may use various price analysis techniques and procedures to make a price reasonableness determination. Offers that do not meet or exceed the technical capability or quality of the item offered to the Government requirement shall not be selected regardless of price.

Options. The Government will evaluate quotations for award purposes by adding the total price for all options to the total price for the basic requirement.

(End of Addendum to 52.212-2)

52.212-3, Offeror Representations and Certifications Commercial Items, applies to this acquisition. Offerors must complete annual representations and certifications electronically via the System for Award Management (SAM) website located at https://www.sam.gov/portal in accordance with FAR 52.212-3, Offerors Representations and Certifications Commercial Items. If paragraph (j) of the provision is applicable, a written submission is required. Offerors must be registered in SAM at time of offer submission.

52.212-4, Contract Terms and Conditions--Commercial Items applies to this acquisition

52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders--Commercial Items (JUL 2020) applies to this acquisition

FAR 52.212-5 applies to this acquisition with the following FAR clauses incorporated by reference;

FAR 52.204-10

Reporting Executive Compensation & First-Tier Subcontract Awards (JUN 2020)

FAR 52.204-16

Commercial and Government Entity Code Reporting (AUG 2020)

FAR 52.204-24

Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (OCT 2020)

FAR 52.209-6

Protecting the Government s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (JUN 2020)

FAR 52.219-6

Notice of Total Small Business Set-Aside (NOV 2020)

FAR 52.219-28

Post Award Small Business Program Representation (NOV 2020)

FAR 52.222-3

Convict Labor (JUN 2003)

FAR 52.222-19

Child Labor Cooperation with Authorities and Remedies (JUL 2020)

FAR 52.222-21

Prohibition of Segregated Facilities (APR 2015)

FAR 52.222-26

Equal Opportunity (SEP 2016)

FAR 52.222-35

Equal Opportunity for Veterans (JUN 2020)

FAR 52.222-36

Equal Opportunity for Workers with Disabilities (JUN 2020)

FAR 52.222-37

Employment Reports on Veterans (JUN 2020)

FAR 52.222-40

Notification of Employee Rights Under the National Labor Relations Act (DEC 2010)

FAR 52.222-50

Combating Trafficking in Persons (OCT 2020)

FAR 52.223-18

Encouraging Contractor Policies to Ban Text Messaging While Driving (JUN 2020)

FAR 52.225-3

Buy American--Free Trade Agreements--Israeli Trade Act (JUL 2020)

FAR 52.225-13

Restrictions on Certain Foreign Purchases (JUN 2008)

FAR 52.232-33

Payment by Electronic Funds Transfer System for Award Management (Oct 2018)

Additional contract requirements or terms and conditions:

52.217-9 Option to Extend the Term of the Contract (MAR 2000) [use when options are included]

(a) The Government may extend the term of this contract by written notice to the Contractor within _____ [insert the period of time within which the Contracting Officer may exercise the option]; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 30 days before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 5 years

852.212-70, Provisions and Clauses Applicable to VA Acquisition of Commercial Items (Apr 2020)

VAAR 852.203-70

Commercial Advertising (MAY 2018)

VAAR 852.232-72

Electronic Submission of Payment Requests (NOV 2018)

VAAR 852.233-70

Protest Content/Alternative Dispute Resolution (OCT 2018)

VAAR 852.233-71

Alternate Protest Procedure (OCT 2018)

VAAR 852.246-71

Rejected Goods (OCT 2018)

852.252-70, Solicitation Provisions or Clauses Incorporated by Reference (Jan 2008)

The following provisions or clauses incorporated by reference in this solicitation must be completed by the offeror or prospective contractor and submitted with the quotation or offer. Copies of these provisions or clauses are available on the Internet at the web sites provided in the provision at FAR 52.252-1, Solicitation Provisions Incorporated by Reference, or the clause at FAR 52.252-2, Clauses Incorporated by Reference. Copies may also be obtained from the contracting officer.

http://www.acquisition.gov/far/index.html

https://www.acquisition.gov/vaar

The following FAR provisions are to be incorporated by reference:

FAR 52.204-7

System for Award Management (OCT 2018)

FAR 52.204-16

Commercial and Government Entity Code Reporting (AUG 2020)

FAR 52.211-6

Brand Name or Equal (AUG 1999)

FAR 52.229-11

Tax on Certain Foreign Procurements Notice and Representation (JUN 2020)

The following VAAR provisions are to be incorporated by reference:

None

The following FAR clauses are incorporated by reference:

FAR 52.203-17

Contractor Employee Whistleblower Rights and Requirement to Inform Employees of Whistleblower Rights (JUN 2020)

FAR 52.204-13

System for Award Management Maintenance (OCT 2018)

FAR 52.204-18

Commercial and Government Entity Code Maintenance (AUG 2020)

FAR 52.232-40

Providing Accelerated Payments to Small Business Subcontractors (NOV 2021)

The following VAAR clauses are to be incorporated by reference:

VAAR 852.212-71

Gray Market Items (APR 2020)

The Defense Priorities and Allocations System (DPAS) does not apply.

Date and Time offers are due to Jeremy.ferrer@va.gov by 4:00pm MT, 4/21/2023.

Name and email of the individual to contact for information regarding the solicitation:

Jeremy Ferrer

Jeremy.ferrer@va.gov