36C24423Q0991 0001.docx

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) 562-23-3-936-0019 503-23-3-225-0245 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

36C24423Q0991 07-27-2023

X X

See CONTINUATION Page

562-3630160-936-825000-3135 SPR0T00A1

503-3630160-225-825000-3131 010044175 X N/A This amendment to solicitation 36C24423Q0991 is to add RFI 36C24423Q1043 to this solicitation. Require a Quote for an Additional 5 Spirometer Systems for the Altoona VA Medical Center to be added to the resulting contract.

The Erie VA Medical Center, and the Altoona VA Medical Center, both have requirements for Brand Name Only - five (5) VYNTUS Spirometer Systems for their associated Community Out Based Clinics (CBOC).

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

VYNTUS BASIC CART - Portable laptop cart for Vyntus SPIRO. Includes; drawer for paper or other small items, syringe holder, transport handle, mouse tray that will accommodate the mouse on left or right side, basket for filters, shelf on bottom for optional printer. This item should come fully assembled.

PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

LOCAL STOCK NUMBER: V-859142-13

LAPTOP LOCK-KEYED

PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing

LOCAL STOCK NUMBER: 34571-001

VYNTUS SPIRO LAPTOP. PC Based Spirometer with direct USB connection to Laptop Computer. Validated Windows 10 Laptop Computer Included.

LOCAL STOCK NUMBER: 25626-001

KIT, HP OFFICE JET

LOCAL STOCK NUMBER: 29225-001

SYRINGE 3 LITE MANUAL CALIBRATION

LOCAL STOCK NUMBER: 720254

SERVICE-VYN SPIRO-PROTECT BASIC-4 YEARS

LOCAL STOCK NUMBER: 34491-104

SERVICE-RDX-SM DEVICE PFT FUNDMTLS TRG-2 DAYS-LIVE WEB BASED Course Objectives.

PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing

LOCAL STOCK NUMBER: 34558-132

VYNTUS SPIRO PNEUMOTACH/ELBOW KIT - Pneumotach supply kit for Vyntus SPIRO. Contains 4 pneumotachs and 5 elbows.

LOCAL STOCK NUMBER: 33120-001

USB AMBIENT MODULE

LOCAL STOCK NUMBER: V-378560

SERVICE-RDX-SM DEVICE FIELD INSTALL-1ST DEVICE

LOCAL STOCK NUMBER: 34588-101

SERVICE-RDX-SM DEVICE FIELD INSTALL-ADDL DEVICE SA

LOCAL STOCK NUMBER: 34588-102

SES CLIENT - Device to be configured as a network client.

LOCAL STOCK NUMBER: 28567-001

SENTRYSUITE WORKFLOW ADVANCED - The SentrySuite Workflow Advanced package includes customization of the standard SentrySuite workflow; set up of a network SQL database; standard predicted sets and predicted set customization; the full SentrySuite report library and up to 5 custom reports; a custom report header and footer; and migration of historical Vyaire pulmonary data to the latest SentrySuite platform. This package also includes a bi-directional interface to the EMR to incorporate inbound ADT or ORM and an outbound PDF report; facilitator-led web-based training to introduce report designer, predicted editing, and comments templates; role based security; an administrative workstation license; a test workstation license; and a Vyaire Project Manager to guide the Pulmonary Lab through the project to completion. This package does not include custom workflow or outbound discrete data elements. Post-implementation application/interface support is only provided when the integration package is purchased with the purchase of new pulmonary function and/or exercise testing equipment. When applicable, post implementation application/interface support will begin upon project completion and continue up to 12 months from the date the new equipment was shipped to the Customer.

PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing

LOCAL STOCK NUMBER: 33285-001

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

LOCAL STOCK NUMBER: V-577201-100

VYNTUS SPIRO SYSTEM INCLUDES: +V-859142-13 VYNTUS BASIC CART Portable laptop cart for Vyntus SPIRO. Includes; drawer for paper or other small items, syringe holder, transport handle, mouse tray that will accommodate the mouse on left or right side, basket for filters, shelf on bottom for optional printer. This item comes fully assembled and does not require or include field service installation. Unpacking and setup by our field service team can be purchased separately. +34571-001 LAPTOP LOCK-KEYED +V-892381 MICROGARD IIB 50PK +25626-001 VYNTUS SPIRO LAPTOP. PC Based Spirometer with direct USB connection to Laptop Computer. Validated Windows 10 Laptop Computer Included. Vyntus Spiro performs all the essential spirometry tests; FVC with Flow Volume Loop, Slow Vital Capacity (SVC), Maximum Voluntary Ventilation ( MVV). Pre and Post Bronchodilator testing levels and Bronchial Challenge Testing software also included. SentrySuite software provides user guidance and feedback regarding test quality according to ATS/ERS or other author's standards. Other software features included; powerful report designer, 10 parameter-linked animated incentives, interactive guided calibration, customizable reference modules, and offline data entry. Device can be used as standalone or can take advantage of our growing family of SentrySuite solutions for workflow and connectivity such as Sentry.Net and SentryConnect. Box of 80 Microgard filters included. 1 year complete warranty included. +29225-001 KIT,OFFICE JET PRINTER +720254 SYRINGE 3 LITER MANUAL CALIBRATION +34552-142 34552-142 SERVICE-RDX-SM DEVICE PFT FUNDMTLS TRG-2 DAYS-CUST HOSTED Course Objectives: Perform pulmonary function testing; customize and configure system settings; perform system calibrations; understand and identify factors that will affect test accuracy; generate results and reports; perform basic troubleshooting and system maintenance; operate the medical device and system properly, safely, and effectively; and understand the ATS Technical Standards and clinical best practices. This program covers up to 2 small PFT devices (e.g., Vyntus SPIRO, Vyntus WALK, MasterScreen PNEUMO, MasterScreen IOS) or 1 small PFT device and Bronchial Challenge Testing. If Bronchial Challenge Training is requested as a part of this program, it will cover the following objectives: know the difference between direct and indirect provocation methods; understand ATS/ERS Clinical Guidelines; perform bronchial challenge testing according to ERS standards; customize and configure system settings; select appropriate pulmonary reference authors based on demographic data and tests performed; conduct biological and mechanical quality control measures including system calibrations; identify factors that will affect test accuracy; use best practices to analyze results and generate reports; and perform basic troubleshooting, system maintenance, and hygiene. Provides training at a single customer location for up to 4 participants. Provides 14 AARC CRCE contact hours for 4 participants when training is purchased in conjunction with a new device. Program includes participant access to Pretraining Modules and a 2-hour Post-Training Follow-up Call with the Clinical Educator, to take place 2-4 weeks following the class. 33120-001 VYNTUS SPIRO PNEUMOTACH/ELBOW KIT Pneumotach supply kit for Vyntus SPIRO. Contains 4 pneumotachs and 5 elbows. +V-892391 Oval filter with nose clip, single patient use, box of 80 +001-709554 PNEUMOTACH W/SCREEN +001-700096 SPARE SCREEN PT36 +001-852352 ELBOW 45 DEGREE +V-378560 USB AMBIENT MODULE +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.

MANUFACTURER PART NUMBER (MPN): C

A.2 DELIVERY SCHEDULE

Attn: Distribution Center 135 E. 38th Street Erie, PA 16504

USA

814-860-2126 jill.friend2@va.gov

5.00

5.00

5.00

5.00

5.00

5.00

5.00

5.00

1.00

4.00

5.00

1.00

6.00

Attn: Warehouse 2907 Pleasant Valley Blvd., Altoona, PA 16602

USA

814-943-8164 x14578 Shane.Reece@va.gov

Department of Veterans Affairs Medical Center

(562) ERIE, PA. 16504, and

(503) Altoona, PA 16602

STATEMENT OF NEED (SON)

TITLE: VYNTUS SPIROS SYSTEMS

INTRODUCTION: The Department of Veterans Affairs Medical Center, Erie, Pa 16504, and Altoona, PA 16602, Medical Services has determined a Brand Name Only need to purchase five (5) VYNTUS Spirometer Systems each for their associated Community Out Based Clinics (CBOCS)

HISTORY/BACKGROUND/PURPOSE: The purpose of this purchase is to provide diagnostic lung/pulmonary screening for our Veterans in the Community Based Outpatient Clinics. Providing this service in the community will increase the number of Veterans that can be seen due to the shorter commutes to the clinics rather than to The Erie VA Medical Center. The implementation of the Spirometry Program at the Community-Based Outpatient Clinics will greatly enhance the care we are providing for our Veterans. It will make it easier for the Pulmonologist to follow disease processes in cases of asthma and reactive airway disease and observe the efficacy of treatment and patient compliance with medication.

DETAILED DESPRIPTION/REQUIREMENTS: Erie Veterans Affairs Medical Center (station 562) located at 135 East 38th St. Erie, PA 16504, and the Altoona VA Medical Center (station 503) located at 2907 Pleasant Valley Blvd. Altoona, PA 16602 are completing Action Item V4AI-VH-10961 to refresh, replace, or expand remote telemetry spirometry with Brand Name Only in the community-based outpatient clinics.

The Brand Name Only Requirement for the Vyntus Spiro is required because it uses the SentrySuite Software which is already in use with the Vyntus One and Vyntus Body Pulmonary Function Systems at both VA’s. The requirements for this action item will be setting up a Vyntus Spiro System in their CBOC clinics.

SALIENT CHARACTERSTICS: To ensure compliance and completion of Action Item V4AI-VH-10961, VA Medical Center’s are requesting a Brand Name Only purchase of five (5) VYNTAS Spirometer Systems compatible with the main PFT labs. The Vyntus Spiro is a small hand-held spirometer that comes complete with a stand and laptop. Reasons for choosing this item include:

· Its 100 % compatible with SentrySuite’s at the main PFT labs.

· It is compact and easily stored

· The easy-to-use SentrySuite software produces comprehensive reports for the pulmonologist to review.

· The Vyntus Spirometer System has proven sensor technology that is easy to clean

Technical Specifications

Flow measurement Type: High-quality pneumotach Range: 0.1 to ± 16 L/s Resolution: 1 mL/s Accuracy: 0.1 to 14 L/s: ± 5% of reading or 0.2 L/s, whichever is greater Resistance: < 0.05 kPa/L/s (0.51 cmH2O/L/s) at 10 L/s

Volume integration Type: Software volume integration of flow signal Range: 30 L (software limited) Resolution: 1 mL Accuracy: 0.5 to 8 L: ± 3% of reading or 0.05 L, whichever is greater

Ambient Temperature: +10 °C to +34 °C (+50 °F to 93.2 °F) Relative humidity: 20 to 80 % RH, non-condensing Ambient pressure: 700 to 1060 hPa (525 to 795 mmHg) Altitude: ≤ 3000 m

Classification of applied parts Type: applied part B

Category according to MDD 93/42/EEC (2007) Complete system: Active class IIa medical product

Standards, directives and market clearances Standards: EN 60601-1, EN 60601-1-2, EN 62304, EN 62366, EN ISO 14971, EN ISO 10993-1 Directives: 93/42/EEC amended by 2007/47/EC; RoHS 2011/65/EU compliant Market clearances: CE, FDA 510(k) clearance

Basic Cart Dimension tota:l 96 cm W × 73 cm D × 117 cm H (37.8” × 28.7” × 46.1”) Weight total: 32.6 kg (72 lbs)

IF Vendor will be on station: Contractor will be on station to provide service and therefore required to take the generalized privacy training: Privacy Training for Personnel Without Access to VA Computer Systems or Direct Access to or the Use of VA Sensitive Information. Copies to be maintained by COR.

DELIVERABLES/INSTALLATION/INCEDENTAL SERVICES:

Please deliver to:

Erie VA Medical Center 135 E. 38th Street Erie, PA 16504 8am – 4pm Monday through Friday except holidays.

Deliveries to CBOC shall be coordinated with Will Taylor (814) 860-2344, and

Altoona VA Medical Center Attn: (VA Purchase Order #) 2907 Pleasant Valley Blvd.

Altoona, PA 16602 Monday – Friday from 7:00am – 3:00pm (excluding federal holidays)

Government Furnished Information or Material:

a. This acquisition does not include Government-furnished property (GFP), identify in the Statement of Need all available information on GFP to be provided, including the make, model, bar code number and serial number, if available, of all accountable assets with an acquisition cost of $500 or more.

b. This acquisition does not include Contractor-acquired property (CAP).

c. "No Government personnel, other than the Contracting Officer, have the authority to change or alter these requirements. The COR shall clarify technical points or supply relevant technical information, but no requirements in this scope of work may be altered as a sole result of such verbal clarification."

Period of Service:

Delivery shall occur within 30 days of receipt of contract or must occur within the timeframe designated by the Federal Government.

INSTRUCTIONS – Brand Name only – VYNTUS Spirometer Systems.

Submission of Questions: Questions regarding this solicitation shall be received no later than Tuesday August 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 ‘36C24423Q0991 – Amendment 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 an Unrestricted requirement in the Open Market under the NAICS in block 10. Quotations shall be received no later than Thursday August 3, 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 ‘ 36C24422Q0991 – Amendment 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.

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

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.

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 End of Document