36C24424Q0077 0002 Final.pdf

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)

1 1

01-17-2024

693-23-2-179-0094

None

36C244

Department of Veterans Affairs Network Contracting Office 4 1010 Delafield Road

Pittsburgh PA 15240

00244

Department of Veterans Affairs Network Contracting Office 4 1010 Delafield Road

Pittsburgh PA 15240

To all Offerors/Bidders

36C24424Q0077

12-19-2023

X

X X

Responses due on January 24, 2024

See CONTINUATION Page

X 1

Infusion Pumps

Closing for revised quotes will be extended until January 24, 2024 at 4:00 PM eastern standard time See attached continuation page – Vendor Questions to Solicitation

Please complete the current blank 6550 form, the completed 6550 form with the original solicitation was uploaded in error.

All other terms and conditions remain unchanged

Andrew Taylor

CONTINUATION PAGE

Questions to the solicitation

The agency solicitation does not include language that the agency will accept equal and comparable offers to the proprietary modular infusion system and devices.

1. Will the Agency accept equal and comparable infusion system devices? Yes

The agency solicitation combines modular infusion devices, Large Volume Pump, PCA Pump and Syringe Pump, as a single system offering which is proprietary to only one manufacturer.

2. When evaluating proposals, will the Agency accept equal and comparable offers at the device level? Yes

The agency extensively uses ECRI evaluations & guidance throughout the solicitation.

Evaluation Background: Large-Volume Infusion Pumps

May 11, 2023 | Evaluations & Guidance

The pumping mechanisms are a mature technology, and drug delivery is consistently accurate across models. Infusion pumps are capable of delivering medications with ±5% accuracy over a range of flow rates (0.1-1,200 mL/hr), making them suitable for a variety of therapy applications.

3. When evaluating proposals, will the Agency minimum flow rate accuracy standard be +/- 5% for all pump devices? From statement of work LVP 4.8 Device must have flow rate specifications capability to range from 0.1-999 mL/hr. A flow rate greater than 999 mL/hr is acceptable but not required. An incremental rate minimum of less than .1 is syringe dependent.

The NIST Cryptographic Module Validation Program issues certificates for specific configurations of infusion pumps. For example, a FIPS 140-2 certificate for an infusion pump will specify the pump’s Module Type, Approved Algorithms, Hardware Version and Firmware Versions to which the certification applies and provides a certificate status and sunset date.

The certificates issued by the NIST Cryptographic Module Validation Program for specific configurations of infusion pumps expressly state the “Status” of the certification, and its “Sunset Date.”

4. When evaluating proposals, will the Agency insist that the certificates for the FDA 510(K) cleared infusion pumps proposed by offerors be in “Active” status? Yes, see paragraph

2.1 from the Statement of Need in the solicitation, which describes the general requirements for the infusion pump systems, stating that they must be FDA approved.

a. Will the Agency require that the Sunset Date of the certification for the offered pumps occur after award, after the contract base period, or after the base year and options expire? The equipment must be FDA approved at the time of award, and the equipment must maintain an FDA approval until the time that VA accepts the pumps. There are no options for service/maintenance or license renewals.

5. When evaluating proposals, will the Agency insist that the infusion pumps proposed by offerors match the configuration details specified in the NIST certificate? Yes, must have certified/compliant 802.11 wireless module to ensure proper authentication with VA wireless network.

a. Will the Agency require offerors to propose infusion pumps that have the same Module Type, Approved Algorithms, Hardware Version and Firmware Versions that are listed in the manufacturer’s FIPS 140-2 NIST Cryptographic Module Validation Program certificate? Yes

6. When evaluating proposals, in accordance with VA Directive 6550, Appendix A, will the agency prohibit devices using 802.11 wireless networking that are not FIPS 140-2 or 140-3 compliant? The VA will prohibit the procurement of those systems. That is one of only 2 hard stops that we currently have as of today. There are some potential changes to the FAR that may make this even more difficult in the future, but they are still under discussion.

The following requirements all require wireless networking:

7.2. Wireless communication must support and use FIPS 140-2 or FIPS 140-3 with provided validation from NIST (National Institute of Standard and Technology) Cryptographic Module Validation Program. If FIPS 140-2 certified, vendor must provide a plan to transition to

FIPS 140-3.

(Reference: FISMA Federal Information Security Management Act, Federal Information Processing Standards Publications 140-2 and 140-3 (FIPS Pub), VA Directive 6550)

2.3. Must have wireless communication (Reference: VA Directive 6550, Industry standard according to this publication: ECRI. Evaluation background: large-volume infusion pumps. Device Evaluation 2022 Mar 3.)

2.4. Must be able to interface with CPRS along with being required to have Cerner capability (Reference: DUSHOM policy; Cerner CareAware Device List Q1 2022 pages 7,8,9)

2.5. System will not operate appropriately without ability to interface with Cerner. Would lose required smart pump features including auto-programming, auto-documentation, and alert management without compatibility with Cerner. ECRI Institute. Infusion pump integration: why is it needed, and what are the challenges? [guidance article]. Health Devices 2013 Jul;42(7):210-

21. aami-infusion-anthology-10-8-20.pdf

2.8. Must send infusion data wirelessly from equipment to central repository for analysis (Reference: Joint Commission Policy: NPSG.03.06.01 – MM.08.01.01, PI.01.01.01, EPs 12, 13, Industry standard according to publication: ECRI. Evaluation background: large-volume infusion pumps. Device Evaluation 2022 Mar 3.)

5.3 Must allow medication drug library catalog updates wirelessly or with approved FIPS portable device.

7. When evaluating proposals, if the device is not FIPS 140-2 or 140-3 compliant, will the device fail to meet these wireless networking requirements?

The device itself does not need to be FIPS 140-2/3 compliant, however the device does need to have a validated wireless module that is compliant. Additionally, that module must be enabled for use.

End of Document