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This document is an amendment to a federal government solicitation for a brand name only Mobile Ultima Cardio2 System Package from MGC Diagnostics to be used at the VA Pittsburgh Healthcare System.

The amendment removes line item 4 for a wireless to wired module, renumbers the remaining line items, and revises the statement of need and instructions to vendors accordingly. The solicitation seeks a complete package including the Ultima Cardio2 system with gas exchange and ECG analysis software, an inkjet printer, interface board, Tango M2 automated blood pressure monitor, Nonin pulse oximeter, exercise interpretation and flow volume loop software options, bronchial provocation software, Corival cycle ergometer, prevent sensors, mouthpieces, nose clips, masks, and two days of onsite training. Products are to be brand name only from MGC Diagnostics and delivered within 30 days to the VA Pittsburgh Healthcare System.

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5. PROJECT NUMBER (if applicable)

CODE

7. ADMINISTERED BY

2. AMENDMENT/MODIFICATION NUMBER

CODE

6. ISSUED BY

8. NAME AND ADDRESS OF CONTRACTOR

4. REQUISITION/PURCHASE REQ. NUMBER

3. EFFECTIVE DATE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED

PAGE OF PAGES

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED

BPA NO.

1. CONTRACT ID CODE

FACILITY CODE

CODE

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

E. IMPORTANT:

is extended,

(a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY is not extended.

12. ACCOUNTING AND APPROPRIATION DATA

(REV. 11/2016)

is required to sign this document and return ___________ copies to the issuing office.

is not, A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

15C. DATE SIGNED

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER

Contractor

16C. DATE SIGNED

14. DESCRIPTION OF AMENDMENT/MODIFICATION

16B. UNITED STATES OF AMERICA

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER

16A. NAME AND TITLE OF CONTRACTING OFFICER

15B. CONTRACTOR/OFFEROR

STANDARD FORM 30

PREVIOUS EDITION NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.243 (Type or print) (Type or print) (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

(Number, street, county, State and ZIP Code) (If other than Item 6) (Specify type of modification and authority) (such as changes in paying office, appropriation date, etc.)

(If required)

(SEE ITEM 11)

(SEE ITEM 13)

(X)

CHECK

ONE

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

(Signature of person authorized to sign) (Signature of Contracting Officer) 646-24-1-233-0066 348423 36C244 Department of Veterans Affairs Network Contracting Office 4 1010 Delafield Road Pittsburgh, PA

15215 36C244 Department of Veterans Affairs Network Contracting Office 4

To all Offerors/Bidders

36C24424Q0134 11-30-2023

X X X

See CONTINUATION Page 646-3640160-233-820100-3131 0100201X9 X N/A This amendment to solicitation 36C24424Q0134 is to remove the previous line item number 4 - Wireless to Wired Module - Mortara X-Scribe 4.0 from the Ultima Cardio2. Line items have been renumber to reflect the removed line item.

Schedule on page 2.

Statement of Need (SON) page 6.

Instructions to Vendors Page 10.

Contracting Officer

CONTINUATION PAGE

A.1 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM NUMBER
DESCRIPTION OF SUPPLIES/SERVICES
QUANTITY
UNIT
UNIT PRICE
AMOUNT
1.00
EA
__________________
__________________

Mobile Ultima Cardio2 System

MANUFACTURER PART NUMBER (MPN): 800840-001

1.00
EA
__________________
__________________

Inkjet Printer

MANUFACTURER PART NUMBER (MPN): 441076-001

1.00
EA
__________________
__________________

Interface Board - External Device Signal I/O Module for Ultima Cardio2.

MANUFACTURER PART NUMBER (MPN): 800706-001

1.00
EA
__________________
__________________

Tango M2 Automated BP Monitor.

MANUFACTURER PART NUMBER (MPN): 800241-001

1.00
EA
__________________
__________________

Nonin XPod Oximeter with Finger Clip Sensor **For Use With Tango BP Monitor Only**

MANUFACTURER PART NUMBER (MPN): 754800-001

1.00
EA
__________________
__________________

Exercise Consult Physician Interpretation Software Option for Ultima Cardio2.

MANUFACTURER PART NUMBER (MPN): 147612-304

1.00
EA
__________________
__________________

Exercise Flow Volume Loop Software Option for Ultima Cardio2.

Note: Requires Bronchial Provocation Software Option.

MANUFACTURER PART NUMBER (MPN): 147612-306

1.00
EA
__________________
__________________

Bronchial Provocation Software Option for Ultima Cardio2.

MANUFACTURER PART NUMBER (MPN): 147612-311

1.00
EA
__________________
__________________

Lode Corival Cycle Ergometer Includes: RS-232 Interface

MANUFACTURER PART NUMBER (MPN): 800015-001

1.00
EA
__________________
__________________

preVent Flow Sensor (Box of 24 Qty).

MANUFACTURER PART NUMBER (MPN): 75100-004

1.00
EA
__________________
__________________

Mouthpiece with Saliva Trap (Qty 50).

MANUFACTURER PART NUMBER (MPN): 758301-001

1.00
EA
__________________
__________________

Nose Clip Padded (Bag of 100 Qty).

MANUFACTURER PART NUMBER (MPN): 536007-003

1.00
EA
__________________
__________________

preVent Mask 12 Pack (Large).

**requires coupler**

MANUFACTURER PART NUMBER (MPN): 670009-003

1.00
EA
__________________
__________________

preVent Mask 24 Pack (Medium).

MANUFACTURER PART NUMBER (MPN): 670009-002

1.00
EA
__________________
__________________

preVent Mask 12 Pack (Small).

MANUFACTURER PART NUMBER (MPN): 670009-001

1.00
EA
__________________
__________________

Two-Day Onsite Operator Training (up to 4 People).

MANUFACTURER PART NUMBER (MPN): 900003-005

GRAND TOTAL
__________________

A.2 DELIVERY SCHEDULE

ITEM NUMBER
SHIPPING INFORMATION
QUANTITY
DELIVERY DATE
0001
SHIP TO:
VA Pittsburgh Healthcare System

University Drive C Imaging Services Pittsburgh,, PA 15240 1001

USA

1.00
30 Days ARO
MARK FOR:
Jason Tedrow, Lead Medical Technologist

412-360-1534 Jason.Tedrow2@va.gov

FOB:
DESTINATION

1.00

1.00

1.00

1.00

1.00

1.00

1.00

1.00

1.00

1.00

1.00

1.00

1.00

1.00

1.00

Statement of Need - Revised VA Pittsburgh Healthcare System MGC Diagnostics Mobile Ultima Cardio2 System Package Background VA Pittsburgh Healthcare System (VAPHS) is in need of a new cardiopulmonary exercise testing at the University Drive campus, Pulmonary department, Medicine Service Line (MSL). The cardiopulmonary functioning will be used to assess cardiorespiratory fitness in patients with heart failure, COVID, and other physical impairments, and to assess related therapeutic interventions.

The system shall be capable of:

· Cardiopulmonary stress testing.

· Energy expenditure data.

· ECG-based ischemic assessments The system shall include the following features:

· Top of the line gas exchange software analysis packages.

· True Breath-by-Breath gas analysis

· Integrated spirometry

· Integrated treadmill and cycle ergometry for programmable protocols.

VAPHS intends to acquire a new complete Brand Name Only MGC Diagnostics Mobile Ultima Cardio2 System Package consisting of:

1. Mobile Ultima Cardio2 System Includes: True Breath-by-Breath Exercise Testing, Digital Mixing Chamber, Mortara X-Scribe 4.0, Wired 12-Lead ECG, Spirometry, Security Software, User Defined Predicteds, Windows 10 Pro All-In-One Computer, 2nd Monitor, 3L Syringe, Startup Kit, Isolation Transformer, Environmental Monitor, Keyboard Tray, Regulator Kit and Gases

2. Printer - Inkjet

3. Interface board – External device signal I/O module for Ultima Cardio2

4. Wireless to Wired Module – Mortara X-Scribe 4.0 wireless to wired module for Ultima Cardio2 Removed and renumber, module is not needed for this application.

5. BP Monitor – Tango M2 automated blood pressure monitor

6. Pulse Oximeter – Nonin xPod Oximeter with finger clip sensor

7. Exercise Consult – Exercise Consult Physician Interpretation Software Option for Ultima Cardio2

8. Exercise FVL - Exercise Flow Volume Loop Software for Cardio2

9. Bronchial Provocation Software Option for Ultima Cardio2

10. Lode Corival Cycle Ergometer w/ RS232 port

11. Two-Day Onsite Operator Training

Technical Specs

ULTIMA SYSTEM

· Workspace: W x D: 24 x 21 in (70 x 53.3 cm)

· Base: W x D: 25 x 31 (63.5 x 78.7 cm)

· Height: 49 in (124.5 cm)

PREVENT FLOW SENSOR

· Bidirectional Pitot tube flow sensor

· Range: ±18 L/s

· Accuracy: ±3% or 50 mL, whichever is greater

· Resistance: <1.5 cm H20 @ 14 L/s

· Dead space: 39 mL

DIRECTCONNECT METABOLIC FLOW SENSOR

· Bidirectional Pitot tube fl ow sensor

· Patent number: 5,038,773

· Accuracy: ±3% or 10 mL, whichever is greater

· Resolution: 2.4 mL/s

· Range: 0–40 L/min

· Application range: 100–2000 mL

· Tidal volume range: 100–2000 mL

POWER REQUIREMENTS

· 100-240 V/50-60 Hz

O2 ANALYSIS

· Type: Galvanic

· Range: 0-100%

· Response: (10-90%) <180 ms

· Accuracy: ±1%

CO2 ANALYSIS

· Type: Non-dispersive infrared (NDIR)

· Range: 0-15%

· Response: (10-90%) <180 ms

· Accuracy: ±0.1% (0-10% CO2)

GAS SAMPLE

· Proprietary gas-drying sample circuit

GAS REQUIREMENTS - ULTIMA CARDIO2

· Calibration gas: 5% CO2, 12% O2, bal N2 (5-7 psi)

· Reference gas (recommended): 21% O2, bal N2(5-7 psi)

DELIVERY

Delivery will be made to the loading dock at the University Drive Division of VA Pittsburgh Healthcare System, University Drive C, Pittsburgh PA 15240.

REPAIR AND MAINTENANCE

The vendor/distributor and/or the manufacturer must provide all necessary procedure manuals, troubleshooting manuals and operator manuals.

On site Installation and Training

1. The vendor will assemble the unit on-site to be scheduled by VAPHS. MGC Diagnostics Field Technicians will unload, stage, assemble, test, clean up and remove the debris. They will be on site for no more than 8 hours.

2. Two-day, up to 8 hours per day, onsite operator training for up to 4 people is included. This will be scheduled by VAPHS within 60 days of installation.

Smoking All VA Pittsburgh property is smoke-free. Contractor personnel will comply with VA Pittsburgh smoking policies. Violations will result in a warning and possible citation.

Privacy Training Contractor may not have access to the VA network or any VA sensitive information under this contract. All Contractors must receive Privacy training annually using one of the following methods:

• Complete “VA Privacy Training for Personnel without Access to VA Computer Systems or Direct Access to or Use to VA Sensitive Information” training by using VA’s TMS system (https://www.tms.va.gov/SecureAuth35/). Contractors may use the TMS Managed Self Enrollment method to complete the training in TMS.

• Complete the hard copy version of “VA Privacy Training for Personnel without Access to VA Computer Systems or Direct Access to or Use to VA Sensitive Information”. Signed training documents must be submitted to the COR.

Training must be completed prior to the performance of the contract and annually thereafter. Proof of training completion must be verified and tracked by the COR.

E.1 52.212-1 INSTRUCTIONS TO VENDORS — COMMERCIAL ITEM SEP 2021

INSTRUCTIONS – Brand Name only – One (1) MGC Diagnostics - Mobile Ultima Cardio2.

Submission of Questions: Questions regarding this solicitation shall be received no later than Friday December 1, 2023, 4:00 PM Eastern Time (ET). Questions received after this time may not be considered for review. Questions shall be submitted to David Santiago – Contract Specialist at david.santiago2@va.gov. Prospective Vendors are asked to submit their questions grouped by solicitation section and making reference to the particular paragraph in that section. The Subject Line for questions shall state ‘36C24424Q0134 – Questions’. Responses to all inquiries/questions will be returned via email to those vendors solicited giving due regard to the proper protection of proprietary information. Vendors shall be responsible for monitoring their email for the agency’s responses. No information concerning this solicitation shall be provided in response to a phone call.

Prospective Vendors are warned against contacting any medical center personnel outside the Procurement Department prior to award of a Contract resulting from this solicitation. If such contact occurs and is found to be prejudicial to competing Vendors, the Vendor making such contact may be excluded from award consideration.

Submission of Quotes: This solicitation is being issued as a Total Small Business Set-aside requirement on the Open Market under the NAICS in block 10. Quotations shall be received no later than Wednesday December 6, 2023, 4:00 PM Eastern Time (ET). Quotations received after this time might not be considered for award. All quotes shall be emailed to david.santiago2@va.gov. The Subject Line for email submissions shall state ‘ 36C24424Q0134 – Quote’.

Quote Content and Submission Instructions: Vendors should review RFQ and are ultimately responsible for ensuring that their quotes fully comply with submission requirements for this RFQ. Each quote shall clearly demonstrate that the Vendor understands both the general and specific technical requirements of the Scope of Work. Failure to explain Vendor’s ability to meet all requirements may result in the Vendor's quote not being considered. The vendor may submit a capability statement to explain technical acceptability. Clarity and completeness of quotes are of the utmost importance. Therefore, quotes must be organized in a practical, clear, and concise manner.

For a response to this solicitation to be considered complete Vendors must comply with the following requirements:

- All Non-Manufactures must submit an Authorized Distributor Letter from the OEM.

- The Vendor must be able to provide a price for all the Items listed in the Schedule.

- Must Sign Block 30a on Cover Sheet of Solicitation, STANDARD FORM 1449

- Vendors must submit a delivery date ARO (estimate delivery date after award).

EVALUATION

Award for this requirement will be made to the vendor who proposes the Lowest Price Technically Acceptable (LPTA) quote to the Government. To be Technically Acceptable:

· The vendor must be an OEM Authorized Reseller as demonstrated by their OEM Authorized Distributor Letter.

· Must provide pricing for all items listed in the Schedule of this Solicitation.

· Must sign the Solicitation, on STANDARD FORM 1449. Vendors must submit a delivery date ARO (estimate delivery date after award).

The Department of Veteran’s Affairs will award to the vendor proposing the best value to the Government.

At the time of evaluation, all quotes will be evaluated to determine the Lowest Priced Quote. At that time, only the Lowest Priced Quote will be forwarded on for Technical Evaluation. If the lowest price quote is found to NOT be technically acceptable, the next lowest priced quote will be forwarded on for technical acceptability. This process will continue until the lowest priced, technically acceptable, quote is identified.

The Department of Veteran Affairs may reject a quote as non-responsive if it is materially unbalanced. A quote is unbalanced when it is based on prices significantly less for some work and significantly overstated for other work, or the prices do not reflect market value.

End Of Document

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