36C24221Q1388.pdf

Combined Synopsis/Solicitation Notice

*= Required Field Combined Synopsis/Solicitation Notice

SUBJECT* Vyntus One Pulmonary Function Test System, Parts and Accessories - Brand Name only

GENERAL INFORMATION

CONTRACTING OFFICE’S ZIP CODE* 12203

SOLICITATION NUMBER* 36C24221Q1388

RESPONSE DATE/TIME/ZONE 09-01-2021 16:00 EASTERN TIME, NEW YORK,

USA

ARCHIVE 30 DAYS AFTER THE RESPONSE DATE

RECOVERY ACT FUNDS N

SET-ASIDE

PRODUCT SERVICE CODE* 6515

NAICS CODE* 334510

CONTRACTING OFFICE ADDRESS

Department of Veterans Affairs

Network Contracting Office 2 (NCO 2)

20 Madison Avenue Ext.

Albany NY 12203

POINT OF CONTACT*

Contract officer

Myra Florisa N. Green

Myra.Green2@va.gov

518-626-5450

PLACE OF PERFORMANCE

ADDRESS

VA Finger Lakes Healthcare System

Bath VAMC and Rochester CBOC

76 Veterans Avenue

Bath NY

POSTAL CODE 14810

COUNTRY USA

ADDITIONAL INFORMATION

AGENCY’S URL https://www.va.gov/finger-lakes-health-care/

URL DESCRIPTION VA Finger Lakes Healthcare System

AGENCY CONTACT’S EMAIL ADDRESS Myra.Green2@va.gov

EMAIL DESCRIPTION Contract Officer

DESCRIPTION

Request for Quote (RFQ) #: 36C24221Q1388

VYNTUS ONE-PFT PC SYSTEM FOR BATH VAMC AND ROCHESTER OUT-

PATIENT CLINIC

(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.

** Quotes are to be provided to Myra Florisa N. Green at Myra.Green2@va.gov no later than 4:00pm EST, September 01, 2021.

Quotes shall not be hand carried. Faxed quotes shall not be accepted. Emailed quotes are the only method of submitted quotes. 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 36C24221Q1388. 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) 2020-08 effective August 13, 2020.

(iv) The North American Industrial Classification System (NAICS) code for this procurement is 339112 with a small business size standard of 1,000 employees.

(v) List of Line Items:

Delivery to the Bath VAMC, 1 Vyntus One-PFT system

Line Item

Description Quantity Unit Unit Price Total Price

0001 31783-001:VYNTUS ONE-PFT

PC System

1 EA

0002 768093: GAS .3%CO .3%CH4

21%02 BAL N2 (ED)

1 EA

0003 V-892590-13: GAS 16%O2

5%CO2 0.3%CO/CH4/BAL N2 E

CYL

1 EA

0004 V-720000: JQM syringe for VA- Test.

1 EA

0005 32924-001: Additional Breathing Circuit for Vyntus ONE. Includes:

1 each of USS Module with polytube adapter, Flow Path Valve, Shutter, and 1 pk of 5 Silicone Valves.

1 EA

0006 97075-PM3-OS: Pulmonary Function and/or Cardiopulmonary Exercise Onsite Training Course for 3 days with a Vyaire Medical, Inc. Clinical Applications Specialist

1 EA

0007 28567-001: SES CLIENT Device to be configured as a network client

1 EA

0008 V-577201-100:

SENTRYCONNECT SEAT

LICENSE FOR SES Single Seat license to connect to SentryConnect gateway- SentrySuite instrument, SentrySuite reading station, Sentry.NET remote access

1 EA

GRAND

TOTAL

Delivery to the Rochester Community Base Outpatient Clinic (CBOC), 1 Vyntus One-PFT system:

Line Item

Description Quantity Unit Unit Price Total Price

0001 31783-001:VYNTUS ONE-PFT

PC System

1 EA

0002 768093: GAS .3%CO .3%CH4

21%02 BAL N2 (ED)

1 EA

0003 V-892590-13: GAS 16%O2

5%CO2 0.3%CO/CH4/BAL N2 E

CYL

1 EA

0004 V-720000: JQM syringe for VA- Test.

1 EA

0005 32924-001: Additional Breathing Circuit for Vyntus ONE. Includes:

1 each of USS Module with polytube adapter, Flow Path Valve, Shutter, and 1 pk of 5 Silicone Valves.

1 EA

0006 97075-PM3-OS: Pulmonary Function and/or Cardiopulmonary Exercise Onsite Training Course for 3 days with a Vyaire Medical, Inc. Clinical Applications Specialist

1 EA

0007 28567-001: SES CLIENT Device to be configured as a network client

1 EA

0008 V-577201-100:

SENTRYCONNECT SEAT

LICENSE FOR SES Single Seat license to connect to SentryConnect gateway- SentrySuite instrument, SentrySuite reading station, Sentry.NET remote access

1 EA

GRAND

TOTAL

(vi) Description of Requirements for the items to be acquired (salient characteristics);

Quantity: 2

Detailed Item Description: Vyntus One-Pulmonary Function Testing (PFT) System

Basis of Design (make/model/Mfr. Part No): CareFusion dba VYAIRE Medical Inc.

Vyntus

Technical Specifications/Salient Characteristics: Vyntus One-PFT PC System

• Additional Requirements:

o 1st year Warranty Included

SALIENT CHARACTERISTICS/MEASUREMENT CAPABILITIES:

• Spirometry (FVC, FEV1, Flow Volume Loop)

• Slow Vital Capacity (SVC, ERV, IC)

• Maximum Voluntary Ventilation (MVV)

• CO-Diffusion SB Real-time: with continuous, high speed gas analysis for calculation of

DLCO, VA, DL/VA

• CO Diffusion Intrabreath: an alternative diffusion method with a non-breath hold maneuver with continuous, high speed gas analysis for calculation of DLCO, VA, DL/A etc.

• Lung Volumes: using the N2 washout method for FRCN2, ERV, RV, TLC, VC, IC and determination of the Lung Clearance Index (LCI)

• Pre and post medication testing for therapy control.

• Maximal Inspiratory and Expiratory Pressures (MIP/MEP)

• Bronchial Challenge Testing

• Breath by Breath Exercise Testing

HARDWARE:

• The main unit contains all gas analyzers (CO/CH4/O2/CO2) in one module

• Fast Multigas analyzer (CO/CH4) for the Diffusion measurements with response time

<150ms

• Fully digital, high speed O2 analyzer, based on electrochemical principle

• Fully digital, high speed CO2 analyzer, based on infrared absorption

• O2 cell simply exchangeable without opening the analyzer unit

• Automatic gas calibration for calibration of all gases with only one click in less than one minute

• USB ambient module for continuously reading ambient data temperature, humidity and barometric pressure

• Factory Calibrated Ultrasonic sensor with 1000Hz sampling rate and double shot technology. Volume accuracy of 2.5%, meeting 2017 ATS/ERS DLCO guidelines.

• Waterproof ultrasonic flow sensor

• Quiet and fast magnetically-controlled shutter system

• Shutter system is free of balloons

• Electronically controlled gas demand valve

• Validated bacterial/viral filters available along with complete hygiene documentation and concept

• Breath by breath measurement CPET measurement system

• Digital bidirectional volume sensor especially suited for CPET testing and weighing no more than 45g

• CPET Volume sensor offered with both reusable and disposable concepts.

• Sp02-sensor directly connectable to analyzer

• Height adjustable cart for sitting and standing position to accommodate the needs of the technician

• Adjustable arm for measuring in sitting and standing position

• Keyboard and mouse that is sealed so that it can be cleaned and disinfected.

GENERAL SOFTWARE FUNCTIONS:

• Compliance with ATS/ERS guidelines including the 2017 DLCO and Reporting guidelines

• Digital Questionnaire can be integrated into patient record

• Mobile review application to allow physicians to interpret testing from any device

• Digital signature for reports

• Report output format selectable as print, monitor view, PDF, TIFF, RTF, JPG

• Online coaching for technician and patient

• Quality feedback based on ATS/ERS guidelines

• GLI reference sets implemented along with many others and the ability to create custom user sets and equations.

• Different patient types for BIO QC, QM validation and BIO controls to help keep

Internal quality control data separated from patient data

• Suggestion of exercise protocol due to reference values and spirometry data

• Editable post exercise test evaluation workflow steps

VYNTUS ONE-PFT PC SYSTEM INCLUDES:

• 1st year warranty

• Analyzer module (O2, CO2, Multigas)

• Breathing circuit (including Ultrasonic sensor, Flow Path Valve, and Demand Valve)

• SentrySuite software, standard cart and arm with adjustable height

• Left/right mousepad

• Validated WIN 10 PC with sanitizable medical keyboard/mouse

• 27 flat panel infinityEdge monitor

• Office Jet printer

• 3-L manual syringe

• O2

• DLCO and calibration gas regulators

• 6 cylinder gas stand

• 1 box of MicroGard IIB and IIC (80 each) filters

• Tests performed: Spirometry (FVC, SVC, MVV)

• Lung subdivisions (FRC-N2, RV, TLC)

• Real-time DLCO (both Single Breath and Intrabreath)

• MIP/MEP

• Pre/post bronchodilator

• Standard software includes:

o Guidance and Stabilitrac instructional applications o Pre-formatted reports and reference sets with design tools for modification o Automated interpretation algorithms, o QA checks and physician interpretation templates.

ONSITE TRAINING:

• Attendee/s will participate in an interactive session on the proper operation of Vyaire pulmonary function and/or cardiopulmonary exercise device/s.

• AARC CRCE credits for up to 3 persons IF the attendee/s are present the entire course with limited interruptions and complete a written exam and survey per AARC requirements.

• CEUs for additional trainees are available for purchase.

TRAINING CANCELLATION POLICIES:

• Notice must be received from customer in writing (via email is acceptable) 15 business days prior to

• the confirmed start date of the Training Course, or the following fees will be assessed per the Vyaire Training

• No fee applied if cancellation notice received from the Customer prior to 15 business days before the start date of the confirmed Training Course.

• One-half of the cost of purchased training cancellation fee applied if cancellation notice received from the Customer is less than 15 business days, but prior to 5 business days, before start date of confirmed Training Course.

• Full cost of purchased training cancellation fee applied if cancellation notice received from Customer less than 5 business days before start date of confirmed Training Course.

• The full cost of purchased training will also be applied to "no shows" by Customer when scheduled to attend training at Vyaire training facility. -Training must be completed within 60 days of purchase date when sold as training only, or within 60 days of installation of capital

• device when training sold with a capital sale, not to exceed one calendar year from original date of purchase.

(vii) Delivery and acceptance is to be F.O.B Destination (FAR 52.247-34) at the:

Department of Veterans Affairs, VA Finger Lakes Health Care System Bath VA Medical Center 76 Veterans Avenue Bath, NY, 14810 and

Department of Veterans Affairs, VA Finger Lakes Health Care System Rochester Calkins VA Clinic 260 Calkins Road Rochester, NY, 14623

Delivery Timeframe: Within 60 days of award unless specified differently within scope of contract

Delivery Markings: Contractor shall deliver items in manufacturer's original sealed containers with manufactures’ name marked thereon. Deliveries shall be marked with the PO and contract number and RPOW JOFOC Tracker # 2021-02-11T08:34:53

Delivery and Installation: will be coordinated through the On-Site Point of Contact (POC). POCs for delivery and install for both facility is Benjamin Herrick at benjamin.herrick@va.gov, phone 607-664-4622.

(viii) 52.212-1, Instructions to Offerors--Commercial

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.

mailto:benjamin.herrick@va.gov

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

(e) 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.

(f) If the acquisition is set-aside for Small Businesses, 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.

(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) Price, (II) Narrative to Support the General Standards of Responsibility

Volume I – Price - The offeror shall complete the pricing schedule provided in

Section (v) above: Price/Cost Schedule.

Volume II – General Standards of Responsibility - To assist the contracting officer in determining if the general and special standards of responsibility applicable to this procurement are met, offerors are asked to provide the following information with their quotes. Failure to include this information could result in a contracting officer’s determination that an otherwise successful offeror is not eligible for contract award.

General Standards of Responsibility:

https://www.vip.vetbiz.gov/

G1: Offeror shall provide a letter of authorization from the manufacturer for each OEM product stating that they are an authorized distributor/reseller.

(End of Addendum to 52.212-1)

(ix) 52.212-2, Evaluation--Commercial Items ADDENDUM to FAR 52.212-2 EVALUATION—COMMERCIAL ITEMS:

(a) Basis of Award. This procurement is being conducted pursuant to FAR Part13 procedures. The Government intends to award a contract resulting from this solicitation to the responsible offeror whose quote, conforming to the solicitation, quotes the lowest price, whose quoted price does not exceed the amount of funding available for the procurement, and whose quoted price is found to be reasonable. Price alone is the sole evaluation factor. Offerors who fail to meet any standard of responsibility will not be eligible to receive contract award.

(b) Evaluation Process. Quotes will be evaluated in the following manner. The lowest-priced quote will be identified. The lowest-priced quote will be evaluated to determine if the quoted price exceeds the amount of funding available for the procurement. If the quoted price does not exceed the amount of funding available for the procurement, the quoted price will be evaluated to determine if it is reasonable. If the quoted price is found to be reasonable, the offeror who submitted this quote will be identified as the “successful offeror.” The contracting officer will then determine if the successful offeror is responsible using the general standards of responsibility applicable to this procurement.

If contract award cannot be made to the successful offeror, the contracting officer will evaluate the next lowest-priced quote following the procedures described above. This process will continue until a contract award can be made, or the contracting officer determines that no contract award can be made. The contracting officer may find all quotes not acceptable and cancel the solicitation if the lowest-priced quote exceeds the amount of funding available for the procurement. The contracting officer may likewise find a quote under evaluation, as well as all remaining quotes, not acceptable and cancel the solicitation if the quote currently under evaluation exceeds the amount of funding available for the procurement. The Government intends to evaluate quotes and award a contract without discussions with offerors. However, the Government reserves the right to conduct discussions at any time if determined by the contracting officer to be in the Government’s interest.

(End of Addendum to 52.212-2)

(x) Offerors are advised to include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications – Commercial Items, with the offer.

(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

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

FAR

52.203-6

Restrictions on Subcontractor Sales to the Government (SEPT 2006), with Alternate I (OCT 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402)

FAR

52.204-10

Reporting Executive Compensation & First-Tier Subcontract Awards (OCT 2016) (Pub. L. 109-282) (31 U.S.C. 6101 note)

FAR

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)

FAR

52.219-8

Utilization of Small Business Concerns (NOV 2016) (15 U.S.C.

637(d)(2) and (3));

FAR

52.219-28

Post Award Small Business Program Representation (Jul 2013) (15 U.S.C 632(a)(2))

FAR

52.222-3

Convict Labor (June 2003) (E.O. 11755)

FAR

52.222-19

Child Labor—Cooperation with Authorities and Remedies (OCT 2016) (E.O. 13126)

FAR

52.222-21

Prohibition of Segregated Facilities (APR 2015)

FAR

52.222-26

Equal Opportunity (SEP 2016) (E.O. 11246)

FAR

52.222-35

Equal Opportunity for Veterans (OCT 2015) (38 U.S.C. 4212)

FAR

52.222-36

Equal Opportunity for Workers with Disabilities (JUL 2014) (29 U.S.C. 793)

FAR

52.222-37

Employment Reports on Veterans (FEB 2016) (38 U.S.C. 4212)

FAR

52.222-40

Notification of Employee Rights Under the National Labor Relations Act (DEC 2010) (E.O. 13496)

FAR

52.222-50

Combating Trafficking in Persons (MAR 2015) (22 U.S.C. chapter 78 and E.O. 13627)

FAR

52.223-18

Encouraging Contractor Policies to Ban Text Messaging While Driving

(AUG 2011)

FAR

52.225–5

Trade Agreements (OCT 2016) (19 U.S.C. 2501, et seq., 19 U.S.C.

3301 note)

FAR Restrictions on Certain Foreign Purchases (JUN 2008) (E.O.'s, 52.225-13 proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury)

FAR

52.232-33

Payment by Electronic Funds Transfer—System for Award Management (Jul 2013) (31 U.S.C. 3332)

(xiii) Additional contract requirements or terms and conditions:

52.252-2, Clauses Incorporated by Reference (Feb 1998)

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 http://www.va.gov/oal/library/vaar/

The following FAR clauses are incorporated by reference:

52.204-7 System for Award Management

The following VAAR clauses are to be incorporated by reference:

852.203-70 Commercial Advertising (JAN 2008); 852.232-72 Electronic Submission of Payment Requests (NOV 2012); 852.246-70 Guarantee (JAN 2008); 852.246-71 Inspection (JAN 2008)

52.252-1, Solicitation Provisions Incorporated by Reference (Feb 1998)

This solicitation incorporates one or more solicitation provisions 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. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision 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)

The following FAR provisions are to be incorporated by reference:

The following VAAR provisions are to be incorporated by reference:

http://www.acquisition.gov/far/index.html http://www.va.gov/oal/library/vaar/ http://www.acquisition.gov/far/index.html http://www.va.gov/oal/library/vaar/index.asp

852.273-70 Late Offers (JAN 2003); 852.273-72 Alternate Evaluation (JAN 2003); and 852.273-74 Award Without Exchanges (JAN 2003).

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

(xv) Date and Time offers are due to Myra Florisa N. Green at Myra.Green2@va.gov by 4:00pm EST, September 01, 2021.

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

Myra Florisa N. Green Myra.Green2@va.gov