CombineSolictiation-MRI_PatientMonitor-MemphisVAMC.pdf

COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS

MRI Patient Monitoring System

RFQ - 36C24920Q0329 Page 1 of 9

I. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, “Streamlined Procedures for Evaluation and Solicitation for Commercial

Items,” as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation document will not be issued.

II. The combined synopsis/solicitation number is 36C24920Q0329. It is issued as a request for quotation (RFQ).

III. The solicitation document and incorporated provisions and clauses are those in effect through

Federal Acquisition Circular, FAC 2020-07 effective 07/02/2020.

IV. The combined synopsis/solicitation is set aside for small Businesses only. Offeror must be registered in System for Award Management (SAM) www.SAM.gov prior to being considered for Award.

The NAICS is 339112, Surgical and Medical Instrument Manufacturing with a small business size standard of 1000 employees for manufacturers. Nonmanufacturing business size standard is

500 employees.

V. & VI. This combined synopsis solicitation is for the following:

DESCRIPTION OF REQUIREMENT:

A patient monitoring system for the MRI examination room.

The offeror is encouraged to converse with the Site Visit POCs and conduct a site visit and product demonstration to provide sufficient data to develop an offer/proposal that will meet the needs of this requirement.

SALIENT FUNTIONAL, PHYSICAL, OR PERFORMANCE FEATURES;

• MRI Patient Monitor that monitors the follow vitals:

o ECG (Electrocardiogram) - Multiple setting for different types of procedures o SpO2 (Pulse Oximetry) o NiBP (Non-invasive Blood Pressure) o CO2 (Capnography, includes end-tidal and fractional inspired) o Temperature- Use both surface and core

• All vital attachments/features should be for all patient types and sizes (e.g. infant, child, adult, etc.)

• No patient PID is sent, just raw data.

• The data does not need to be stored or saved.

• Printing from the patient monitor or remote workstation/monitor is not required.

RFQ - 36C24920Q0329 Page 2 of 9

• A wireless connection for the MRI patient monitor to connect to a remote monitor/display in the control room without any degradation of signal or data transfer when MRI is operating.

• One Integrated Unit: All components and parameters built into the one integrated unit

• Alarms: Must be FDA approved break thru alarms for Desaturation, Apnea, Bradycardia, Tachycardia and low O2 .

• Battery Management: Swappable batteries enable users to always have a charged battery when needed. To prevent clinical loss of vital SPO2 and/or ECG.

• Durable and reliable – Must handle 3 Tesla (T) or 30,000 Gauss of magnetic induction without any data transmission anomalies or errors.

• On-site Training of BioMed and MR/Radiology staff in basic use, care, and maintenance

• Installation

• Meet FDA 510k Pre-market Notification standards o Regulation Number: 21 CFR 21 CFR 870.2300 o Regulation Name: Cardiac Monitor (Including Cardiotachometer and Rate Alar) o Regulatory Class: Class II o Product Code: MWI

• Easy to Maintain and Clean

(a) Gray market items are Original Equipment Manufacturers (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) Vendor 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.

SERVICES:

VII. FOB Destination, Delivery and Acceptance will be:

Memphis VA Medical Center, 1030 Jefferson Avenue, Memphis, TN 38104

RFQ - 36C24920Q0329 Page 3 of 9

Date for Delivery: No later than 30 days after receipt of order (ARO) or award of contract. If

Must be FOB Destination.

VIII. Provision 52.212-1, Instructions to Offerors Commercial (Oct 2018), applies to this acquisition.

Addendum to FAR 52.212-1 Instructions to Offerors Commercial Items:

(c): Period for acceptance of Quote is a minimum of 60 calendar days.

(d) Product samples/demonstration. When required by the solicitation, product samples/demonstration shall be submitted at or prior to the time specified for receipt of offers.

Unless otherwise specified in this solicitation, these samples/demonstration shall be submitted at no expense to the Government, and returned at the sender’s request and expense, unless they are destroyed during pre-award testing.

Should a product demonstration be given, the setup, execution, and dismantling combined shall not exceed one hour’s time.

Site Visit POC’s will note product demonstration and any questions and responses to offeror in accordance with evaluation considerations.

(End of Addendum)

All provisions and clauses applicable to this solicitation can be viewed in full text using the following web addresses:

http://www.acquisition.gov/far/index.html (FAR) http://www.va.gov/oal/library/vaar/index.asp (VAAR)

IX. Provision 52.212-2, Evaluation Commercial Items (OCT 2014), applies to this acquisition.

(a) The Government will award a contract resulting from this solicitation to the responsible offeror based on the Best Value to the Government via a comparative evaluation: i.e. Award will be made to the government quote that meets or exceeds ALL requirement of this solicitation at a fair and reasonable price (Firm Fixed Price) based on both price and non-price considerations like technical specifications, Special features, Environmental and energy efficiency, warranty, delivery schedule, any free accessories, supplies or services, etc.

(b) Options. NA

Addendum to FAR 52.212-2, Evaluation Commercial Items:

(a) DEFINITION(S) - Comparative Evaluation: The act of comparing two or more offers or proposals in response to an RFQ or RFP. The item-by-item comparison is performed by

RFQ - 36C24920Q0329 Page 4 of 9 comparing each offer or proposal to one another to determine which provides the best benefit to the government.

BASIS FOR AWARD- Best Value to the Government using the Comparative Evaluation

Method.

Award will be made to the Offeror who is deemed responsible in accordance with the Federal

Acquisition Regulation; whose offer conforms to the solicitation requirements (to include all terms, conditions, representations, and certifications, and all other information required by the solicitation); and, whose proposed price is fair and reasonable. This may result in an award to a higher-priced Offeror. The government is not bound to make award to an offer/response that exceeds the requirements if it provides no value or benefit to the government.

(End of Addendum)

X. Provision 52.212-3 Offeror Representations and Certifications Commercial items (June

2020) applies to this acquisition. Offeror MUST provide with their quote a completed copy of their Representations and Certifications per 52.212-1(b)(8). Offeror Representations and

Certifications can be accessed electronically at the following web address:

https://www.acquisition.gov/far/index.html or https://www.sam.gov/portal/SAM/portal

XI. Clause 52.212-4, Contract Terms and Conditions—Commercial Items, applies to this acquisition and does not include an addendum.

XII. Clause 52.212-5, Contract Terms and Conditions Required To Implement Statutes or

Executive Orders—Commercial Items, applies to this acquisition including, if any, additional

FAR clauses cited in the clause are applicable to the acquisition.

• (4) 52.204–10, Reporting Executive Compensation and First-Tier Subcontract Awards (Oct

2018) (Pub. L. 109–282) (31 U.S.C. 6101 note).

• (8) 52.209-6, Protecting the Government's Interest When Subcontracting with Contractors

Debarred, Suspended, or Proposed for Debarment. (OCT 2015) (31 U.S.C. 6101 note).

• (27) 52.222-3, Convict Labor (June 2003) (E.O. 11755).

• (28) 52.222–19, Child Labor—Cooperation with Authorities and Remedies (JAN 2018)

(E.O. 13126).

• (29) 52.222-21, Prohibition of Segregated Facilities (APR 2015).

• (30)(i) 52.222–26, Equal Opportunity (SEP 2016) (E.O. 11246).

• (35)(i) 52.222-50, Combating Trafficking in Persons (JAN 2019) (22 U.S.C. chapter 78 and

E.O. 13627).

• (44) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving

(AUG 2011)

• (58) 52.232-33, Payment by Electronic Funds Transfer—System for Award Management

(Oct 2018) (31 U.S.C. 3332)

• (61) 52.239-1, Privacy or Security Safeguards (AUG 1996) (5 U.S.C. 552a)

52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

https://www.acquisition.gov/far/index.html https://www.sam.gov/portal/SAM/portal

RFQ - 36C24920Q0329 Page 5 of 9

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

http://www.acquisition.gov/far/index.html (FAR) http://www.va.gov/oal/library/vaar/index.asp (VAAR)

FAR Number Title Date

52.204-13 SYSTEM FOR AWARD MANAGEMENT

MAINTENANCE

OCT 2016

52.204-18

52.227-19

COMMERCIAL AND GOVERNMENT ENTITY CODE

MAINTENANCE

COMMERCIAL COMPUTER SOFTWARE LICENSE

JUL 2016

DEC 2007

52.232-8 DISCOUNTS FOR PROMPT PAYMENT FEB 2002

(End of Clause)

VAAR 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.

FAR Number Title Date

52.212-3 Offeror Representations and Certifications Commercial Items OCT 2018

(End of Provision)

VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

The Contractor shall not make reference in its commercial advertising to Department of Veterans

Affairs contracts in a manner that states or implies the Department of Veterans Affairs approves or endorses the Contractor’s products or services or considers the Contractor’s products or services superior to other products or services.

(End of Clause)

VAAR 852.211-70 EQUIPMENT OPERATION AND MAINT MANUALS (NOV 2018)

The Contractor shall follow standard commercial practices to furnish manual(s), handbook(s) or brochure(s) containing operation, installation, and maintenance instructions, including pictures or illustrations, schematics, and complete repair/test guides, as necessary, for technical medical

RFQ - 36C24920Q0329 Page 6 of 9 equipment and devices, and/or other technical and mechanical equipment provided per CLIN(s) .

The manuals, handbooks or brochures shall be provided in hard copy, soft copy or with electronic access instructions, consistent with standard industry practices for the equipment or device. Where applicable, the manuals, handbooks or brochures will include electrical data and connection diagrams for all utilities. The documentation shall also contain a complete list of all replaceable parts showing part number, name, and quantity required.

(End of Clause)

VAAR 852.246-71 REJECTED GOODS (OCT 2018)

(a) Supplies and equipment. Rejected goods will be held subject to Contractor’s order for not more than 15 days, after which the rejected merchandise will be returned to the Contractor’s address at the Contractor’s risk and expense. Expenses incident to the examination and testing of materials or supplies that have been rejected will be charged to the Contractor.

(b) Perishable supplies. The Contractor shall remove rejected perishable supplies within 48 hours after notice of rejection. Supplies determined to be unfit for human consumption will not be removed without permission of the local health authorities. Supplies not removed within the allowed time may be destroyed. The Department of Veterans Affairs will not be responsible for, nor pay for, products rejected. The Contractor will be liable for costs incident to examination of rejected products.

VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV

2018)

(a) Definitions. As used in this clause—

(1) Contract financing payment has the meaning given in FAR 32.001;

(2) Designated agency office means the office designated by the purchase order, agreement, or contract to first receive and review invoices. This office can be contractually designated as the receiving entity. This office may be different from the office issuing the payment;

(3) Electronic form means an automated system transmitting information electronically according to the accepted electronic data transmission methods and formats identified in paragraph (c) of this clause. Facsimile, email, and scanned documents are not acceptable electronic forms for submission of payment requests;

(4) Invoice payment has the meaning given in FAR 32.001; and

(5) Payment request means any request for contract financing payment or invoice payment submitted by the contractor under this contract.

(b) Electronic payment requests. Except as provided in paragraph (e) of this clause, the contractor shall submit payment requests in electronic form. Purchases paid with a Government-

RFQ - 36C24920Q0329 Page 7 of 9 wide commercial purchase card are considered to be an electronic transaction for purposes of this rule, and therefore no additional electronic invoice submission is required.

(c) Data transmission. A contractor must ensure that the data transmission method and format are through one of the following:

(1) VA’s Electronic Invoice Presentment and Payment System at the current website address provided in the contract.

(2) Any system that conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) and chartered by the American National

Standards Institute (ANSI).

(d) Invoice requirements. Invoices shall comply with FAR 32.905.

(e) Exceptions. If, based on one of the circumstances in this paragraph (e), the Contracting

Officer directs that payment requests be made by mail, the Contractor shall submit payment requests by mail through the United States Postal Service to the designated agency office.

Submission of payment requests by mail may be required for—

(1) Awards made to foreign vendors for work performed outside the United States;

(2) Classified contracts or purchases when electronic submission and processing of payment requests could compromise the safeguarding of classified or privacy information;

(3) Contracts awarded by contracting officers in the conduct of emergency operations, such as responses to national emergencies;

(4) Solicitations or contracts in which the designated agency office is a VA entity other than the VA Financial Services Center in Austin, Texas; or

(5) Solicitations or contracts in which the VA designated agency office does not have electronic invoicing capability as described above.

(End of Clause)

XIII. Additional Solicitation Terms and Conditions

The certification and accreditation requirements do not apply, and security accreditation package is not required.

Site Visit (Apr 1984)

Offerors or quoters are urged to inspect the site where services are to be performed and to satisfy themselves regarding all general and local conditions that may affect the cost of contract performance, to the extent that the information is reasonably obtainable. In no event shall failure to inspect the site constitute grounds for a claim after contract award.

RFQ - 36C24920Q0329 Page 8 of 9

(End of provision)

Coordination for site visit will be done through the following points of contact (POC) at

Memphis VAMC:

Primary POC: Renee Woods, renee.woods@va.gov, (901) 523-8990 ext. 7978

Secondary POC: Darryl Snyder, darryl.snyder@va.gov, wk: (901) 523-8990 ext. 5208

XIV. – Intentionally Left Blank.

XV. This RFQ closes August 10, 2020, 0900 hrs (EDT). Submit all quotes and applicable attachments [see VAAR 852.252-70] by e-mail to sascha.hertslet@va.gov with subject line

“RFQ 36C24920Q0329-MRI Patient Monitor.”

Final Offer package will be put into one .pdf-formatted attachment.

Multiple emails will not be accepted.

Our email server has a size limitation of 30 GB. Zip files will be removed and therefore, will not be considered.

Email attachment must be in .pdf format and in the English language. Font type & size must be appropriate for easy and quick viewing, 10 point or greater. Only acceptable font types are

Calibri, Times New Roman, Courier, or Arial. Documents must only be 8 ½ x 10 inches in size, with one-inch margins all around. No more than 10 pages in the final pdf attachment.

Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-

1(f).

The Government reserves the right to make no award at all.

May include a link in the quote to any video product demonstration.

Must include offer’s DUNS

To facilitate the award process, all quotes must include a statement regarding the terms and conditions herein as follows:

"The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition."

OR

"The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:"

Quoter shall list exception(s) and rationale for the exception(s).

mailto:renee.woods@va.gov mailto:darryl.snyder@va.gov mailto:sascha.hertslet@va.gov

RFQ - 36C24920Q0329 Page 9 of 9

XVI. Phone calls and fax will not be accepted, all questions or concerns must be submitted via email to sascha.hertslet@va.gov, with subject line “Questions- RFQ 36C24920Q0329-MRI

Patient Monitor” by Thursday, August 6, 2020, 17:00 hours (CDT).

mailto:sascha.hertslet@va.gov