36C25922Q0830.docx

TMS UNIT SALIENT CHARACTERISTICS

GENERAL INFORMATION

SET-ASIDE

Network Contracting Office

NCO 19

6162 South Willow Drive, Suite 300 Greenwood Village CO 80111

POINT OF CONTACT*

PLACE OF PERFORMANCE

VA Montana Healthcare Systems

3687 Veterans Drive

Ft. Harrison MT

COUNTRY

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

The VA Montana Healthcare System (VAMHS) in Fort Harrison, Montana will be taking services to veterans across the state using a Mobile Medical Unit (MMU). The VAMHS plans to purchase a transcranial magnetic stimulation (TMS) to have installed in the MMU. The TMS unit must be installed by a manufacturer’s certified representative in a manner to allow it to be moved in and out of the MMU.

Request for Quote (RFQ) #: 36C25922Q0830 Transcranial Magnetic Stimulation

(i) 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 3:00pm MT, 9/26/2022 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 jacqueline.obryan@va.gov no later than 2:00pmMT, 9/28/2022.

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.

(ii) This is a Request for Quote (RFQ) and the solicitation number is 36C25922Q0830. The government anticipates awarding a firm-fixed price contract resulting from this solicitation.

(iii) This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2022-06 effective May 26, 2022.

(iv) The North American Industrial Classification System (NAICS) code for this procurement is 334510 with a small business size standard of 1,250 Employees. This solicitation is a 100% set-aside for Small Business.

(v) List of Line Items;

(vi) Description of Requirements for the items to be acquired: See attached Salient Characteristics

(vii) Delivery and acceptance is to be F.O.B Destination (FAR 52.247-34) at the Veterans Affairs Medical Center, located at VA Montana Healthcare System 3687 Veterans Drive Ft. Harrison, MT 59636-9703

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

ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL

(a) 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.

(b) 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.

(c) 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.

(d) 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—

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

ii. Clearly identify the item by-

1. Brand name, if any and

2. Make or model number,

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

iv. 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

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

(f) 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.

(g) 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.

(h) 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.

(i) 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.

(j) Submission of quote shall include the following volumes: (I) Technical capability or quality of the item offered to meet the Government requirement; (II) - Completion of “Attachment - VAAR Clause 852.219-78 VA Notice of Limitations on Subcontracting-Certificate of Compliance for Supplies and Products (DEVIATION)”; (III) Price; (IV) Manufacturer Information; and (V) Product brochure.

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 - Completion of “Attachment - VAAR Clause 852.219-78 VA Notice of Limitations on Subcontracting-Certificate of Compliance for Supplies and Products (DEVIATION)” The offeror shall complete the “Attachment - VAAR Clause 852.219-78 VA Notice of Limitations on Subcontracting-Certificate of Compliance for Supplies and Products (DEVIATION)” and submit as part of the quote.

Volume III – Price

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

Volume IV – Manufacturer Information

Name and address of manufacturer

Volume V – Product Brochure

Product brochure or equivalent that includes all features, dimensions, capabilities, and manufacturer warranties.

(End of Addendum to 52.212-1)

(ix) 52.212-2, Evaluation--Commercial Items applies to this acquisition

ADDENDUM to FAR 52.212-2 EVALUATION—COMMERCIAL ITEMS:

(a) 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.

(b) 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. Completion of “Attachment - VAAR Clause 852.219-78 VA Notice of Limitations on Subcontracting- Certificate of Compliance for Supplies and Products (DEVIATION)” Factor 3. Price

(c) 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. Completion of “Attachment - VAAR Clause 852.219-78 VA Notice of Limitations on Subcontracting-Certificate of Compliance for Supplies and Products (DEVIATION)”: The Government will evaluate the responses an offeror makes to Attachment - VAAR Clause 852.219-78 VA Notice of Limitations on Subcontracting-Certificate of Compliance for Supplies and Products (DEVIATION)” for completeness. If an offeror fails to complete Attachment - VAAR Clause 852.219-78 VA Notice of Limitations on Subcontracting-Certificate of Compliance for Supplies and Products (DEVIATION)” their quote will be determined ineligible for award.

Factor 3. Price: The Government will evaluate the price by adding the total of all line item prices. 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.

(End of Addendum to 52.212-2)

(x) 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.

(xi) 52.212-4, Contract Terms and Conditions--Commercial Items – applies to this acquisition

(xii) 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;

(xiii) Additional contract requirements or terms and conditions:

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

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:

The following VAAR provisions are to be incorporated by reference:

None

The following FAR clauses are incorporated by reference:

The following VAAR clauses are to be incorporated by reference:

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

(xv) Date and Time offers are due to jacqueline.obryan@va.gov by 2:00pm MT, 9/28/2022.

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

Jacqueline O’Bryan Jacqueline.Obryan@va.gov

Combined Synopsis/Solicitation Notice Combined Synopsis/Solicitation Notice

Combined Synopsis/Solicitation Notice

1) Background The VA Montana Healthcare System (VAMHS) in Fort Harrison, Montana will be taking services to veterans across the state using a Mobile Medical Unit (MMU). The VAMHS plans to have a transcranial magnetic stimulation (TMS) installed in the MMU. The TMS unit must be installed in a manner to allow it to be moved in and out of the MMU.

2) Essential/significant physical, functional, or performance characteristics of TMS device for MMU.

a) TMS medical device system must be able to deliver repeatable, reliable pulse frequency, pulse train, and time between pulse trains. There must be no difference in power/strength of pulse delivery from first to last pulse. Power - 120% of motor threshold as separately determined for each patient prior to treatment sessions. MUST be iTBS (intermittent Theta Burst) protocol capable.

b) TMS medical device system must have a cooling system that prevents the coil from overheating. An air-cooled unit is required instead of water cooled to prevent the water-cooling system from freezing in cold weather in the event of a MMU environmental failure. Features that prevent the TMS unit from being unusable in the cold climate when installed in a Mobile Medical Unit parked outdoors in Montana is very important.

c) TMS medical device system must have a method of accurately repositioning and maintaining the coil on the patient’s head from one treatment to the next to ensure repeatable treatment location. The coil must be gravity free. The TMS device must have neuro-navigation capabilities that are integrated with the TMS device package.

d) TMS medical device system must have an adjustable chair for patients to allow correct positioning during TMS treatment. The TMS device and chair must come as a unit.

e) TMS medical device system must be a figure of 8 coil configuration due to lower risk of seizure which is desired within the Mobile Medical Unit.

f) TMS medical device system must be properly grounded to be shock proof.

g) TMS medical device system must be delivered and setup/installed into the MMU by the manufacturers’ certified technicians. Installation will occur at VA Montana Healthcare System, 3687 Veterans Drive, Fort Harrison, MT 59636-9703.

h) TMS medical device system must ensure all medical devices will be calibrated when initially installed and recalibrated according to manufacturer's specifications on a regular schedule by certified personnel to ensure patient safety (magnetic field strength should be defined and measurable).

i) TMS medical device system must operate in normal room temperature environment (59°- 86°F).

j) TMS medical device system must have built in/integrated EMG abilities for motor threshold (MT) determination.

k) TMS medical device system must have technology supported customer service.

l) TMS medical device system must provide device training and certificate of training for medical staff for initial installation.

m) TMS medical device system must include a warranty by the device maker for stabilizing options to maintain the integrity of the device while traveling.

Dimensions – Offers must include the dimensions of the TMS unit. The TMS medical device must fit on and move through a standard ADA wheelchair lift and door.

Industry Standard –Must meet all standards for standard medical equipment (FDA approved for clinical treatment).

Applicable model/make/catalog number – This is a brand-name or equal requirements. Offers must include the name and address of the manufacturer, the TMS brochure listing all features, the dimensions, and a listing of all manufacturer warranties.

VA NOTICE OF LIMITATIONS ON SUBCONTRACTING—CERTIFICATE OF COMPLIANCE FOR SUPPLIES AND PRODUCTS (SEP 2021) (DEVIATION)

0. Pursuant to 38 U.S.C. 8127(k)(2), the offeror certifies that—

(1) If awarded a contract (see FAR 2.101 definition), it will comply with the limitations on subcontracting requirement as provided in the solicitation and the resultant contract, as follows: [Offeror check the appropriate box]

(i) [ ] In the case of a contract for supplies or products (other than from a non-manufacturer of such supplies), it will not pay more than 50% of the amount paid by the government to it to firms that are not VIP- listed SDVOSBs as set forth in 852.219-10 or VOSBs as set forth in 852.219-11. Any work that a similarly situated VIP-listed subcontractor further subcontracts will count towards the 50% subcontract amount that cannot be exceeded. Cost of materials are excluded and not considered to be subcontracted.

(ii) [ ] In the case of a contract for supplies from a nonmanufacturer, it will supply the product of a domestic small business manufacturer or processor, unless a waiver as described in 13 CFR 121.406(b)(5) is granted. The offeror understands that, as provided in 13 CFR 121.406(b)(7), such a waiver has no effect on requirements external to the Small Business Act, such as the Buy American Act or the Trade Agreements Act.

(2) Manufacturer or nonmanufacturer representation and certification. [Offeror fill-in—check each applicable box below. The offeror must select the applicable provision below, identifying itself as either a manufacturer or nonmanufacturer]:

(i) [ ] Manufacturer or producer. The offeror certifies that it is the manufacturer or producer of the end item being procured, and the end item is manufactured or produced in the United States, in accordance with paragraph (a)(1)(i).

(ii) [ ] Nonmanufacturer. The offeror certifies that it qualifies as a nonmanufacturer in accordance with the requirements of 13 CFR 121.406(b) and paragraph (a)(1)(ii). The offeror further certifies it meets each element below as required to qualify as a nonmanufacturer. [Offeror fill-in—check each box below.] [ ] The offeror certifies that it does not exceed 500 employees (or 150 employees for the Information Technology Value Added Reseller exception to NAICS code 541519, which is found at 13 CFR 121.201, footnote 18).

[ ] The offeror certifies that it is primarily engaged in the retail or wholesale trade and normally sells the type of item being supplied.

[ ] The offeror certifies that it will take ownership or possession of the item(s) with its personnel, equipment, or facilities in a manner consistent with industry practice.

(iii) [ ] If this is a multiple item acquisition, the offeror certifies that at least 50% of the estimated contract value is composed of items that are manufactured by small business concerns.

(3) The offeror acknowledges that this certification concerns a matter within the jurisdiction of an Agency of the United States. The offeror further acknowledges that this certification is subject to Title 18, United States Code, Section 1001, and, as such, a false, fictitious, or fraudulent certification may render the offeror subject to criminal, civil, or administrative penalties, including prosecution.

(4) If VA determines that an SDVOSB/VOSB awarded a contract pursuant to 38 U.S.C. 8127 did not act in good faith, such SDVOSB/VOSB shall be subject to any or all of the following:

(i) Referral to the VA Suspension and Debarment Committee;

(ii) A fine under section 16(g)(1) of the Small Business Act (15 U.S.C. 645(g)(1)); and

(iii) Prosecution for violating section 1001 of title 18.

(b) The offeror represents and understands that by submission of its offer and award of a contract it may be required to provide copies of documents or records to VA that VA may review to determine whether the offeror complied with the limitations on subcontracting requirement specified in the contract or to determine whether the offeror qualifies as a manufacturer or nonmanufacturer in compliance with the limitations on subcontracting requirement. Contracting Officer may, at their discretion, require the Contractor to demonstrate its compliance with the limitations on subcontracting at any time during performance and upon completion of a contract if the information regarding such compliance is not already available to the Contracting Officer. Evidence of compliance includes, but is not limited to, invoices, copies of subcontracts, or a list of the value of tasks performed.

(c) The offeror further agrees to cooperate fully and make available any documents or records as may be required to enable VA to determine compliance. The offeror understands that failure to provide documents as requested by VA may result in remedial action as the Government deems appropriate.

(d) Offeror completed certification/fill-in required. The formal certification must be completed, signed, and returned with the offeror’s bid, quotation, or proposal. The Government will not consider offers for award from offerors that do not provide the certification, and all such responses will be deemed ineligible for evaluation and award.

Certification:

I hereby certify that if awarded the contract, [insert name of offeror] qualifies as a manufacturer or nonmanufacturer as stated herein and that if awarded the contract, [insert name of offeror] will comply with the limitations on subcontracting requirement specified in the resultant contract, unless a waiver as described in 13 CFR 121.406(b)(5) is granted. I further certify that I am authorized to execute this certification on behalf of [insert name of offeror].

Printed Name of Signee: _________________________________ Printed Title of Signee: ________________________________ Signature: ______________________________________________ Date: ___________________________________________________ Company Name and Address: _______________________________ (End of clause)

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