7A20--Implant Tracking Software

PAGE 1 OF

1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

UEI:

EFT:

PHONE:

FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA

26. TOTAL AWARD AMOUNT (For Govt. Use Only)

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR

31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT)

30c. DATE SIGNED

31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT)

31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. NOV 2021)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

62

36C26223Q1730

09-06-2023

Anette Doan

562-766-2200

09-15-2023

12PM

PDT

36C262

Department of Veterans Affairs

Network Contracting Office 22

4811 Airport Plaza Drive

Suite 600

Long Beach CA 90815

X

X

513210

$47 Million

N/A

X

36C691

Department of Veterans Affairs

Greater Los Angeles VA Healthcare System

West Los Angeles VA Medical Center

11301 Wilshire Blvd

Los Angeles CA 90073

36C262

Department of Veterans Affairs

Network Contracting Office 22

4811 Airport Plaza Drive

Suite 600

Long Beach CA 90815

Department of Veterans Affairs

Financial Services Center

Submit invoices electronically to:

www.tungsten-network.com

1-877-489-6135

PLEASE ENSURE THE FOLLOWING INFORMATION IS REFERENCED

ITEM SCHEDULE, SALIENT CHARACTERISTICS, AND ALL CLAUSES

DELIVER BY: 365 Calendar Days ARO (INSTALL 10 Calendar Days ARO)

QUOTE MUST BE SUBMITTED VIA EMAIL TO ANETTE.DOAN@VA.GOV

QUOTE MUST BE VALID FOR AT LEAST 60 DAYS

ALL QUESTIONS MUST BE RECEIVED BY 12:00 PM PST ON

SEPTEMBER 11, 2023.

OFFERS TO THIS SOLICITATION SHALL BE E-MAILED

NO LATER THAN 12:00 PM PST ON SEPTEMBER 15, 2023.

X

X

X

1

CECIL S. NICHOLS

VA-VHA-2021-84859FDA

36C26223Q1730

Page 1 of 62

Page 2 of 47

Page 1 of 62

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS 4

B.1 CONTRACT ADMINISTRATION DATA 4

B.2 STATEMENT OF WORK 5

B.3 PRICE/COST SCHEDULE 7

ITEM INFORMATION 7

B.4 DELIVERY SCHEDULE 7

SECTION C - CONTRACT CLAUSES 8

C.1 52.204-23 PROHIBITION ON CONTRACTING FOR HARDWARE, SOFTWARE, AND SERVICES DEVELOPED OR PROVIDED BY KASPERSKY LAB AND OTHER COVERED ENTITIES (NOV 2021) 8

C.2 52.204-27 PROHIBITION ON A BYTEDANCE COVERED APPLICATION (JUN 2022). 9

C.3 52.212-4 CONTRACT TERMS AND CONDITIONS COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (DEC 2022) 10

C.4 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (JUN 2023) 15

C.5 52.217-6 OPTION FOR INCREASED QUANTITY (MAR 1989) 23

C.6 52.219-6 NOTICE OF TOTAL SMALL BUSINESS SET-ASIDE (NOV 2020) 23

C.7 52.219-13 NOTICE OF SET-ASIDE OF ORDERS (MAR 2020) 23

C.8 52.219-14 LIMITATIONS ON SUBCONTRACTING (SEP 2021) 24

C.9 52.225-1 BUY AMERICAN SUPPLIES (OCT 2022) 25

C.10 52.232-33 PAYMENT BY ELECTRONIC FUNDS TRANSFER SYSTEM FOR AWARD MANAGEMENT (OCT 2018) 26

C.11 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998) 27

C.12 VAAR 852.212-71 GRAY MARKET AND COUNTERFEIT ITEMS (FEB 2023) 28

C.13 VAAR 852.219-75 VA NOTICE OF LIMITATIONS ON SUBCONTRACTING CERTIFICATE OF COMPLIANCE FOR SERVICES AND CONSTRUCTION (JAN 2023) (DEVIATION) 28

C.14 VAAR 852.219-76 VA NOTICE OF LIMITATIONS ON SUBCONTRACTING CERTIFICATE OF COMPLIANCE FOR SUPPLIES AND PRODUCTS (NOV 2022) 30

C.15 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018) 32

C.16 VAAR 852.247-71 DELIVERY LOCATION (OCT 2018) 33

C.17 VAAR 852.247-72 MARKING DELIVERABLES (OCT 2018) 33

C.18 VAAR 852.247-73 PACKING FOR DOMESTIC SHIPMENT (OCT 2018) 33

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS 35

SECTION E - SOLICITATION PROVISIONS 36

E.1 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021) 36

E.2 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS 38

E.3 52.211-6 BRAND NAME OR EQUAL 38

E.4 52.212-1 INSTRUCTIONS TO OFFERORS COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2021) 38

E.5 ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES 42

E.6 52.212-2 EVALUATION COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2021) 44

E.7 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (DEC 2022) 45

E.8 52.216-1 TYPE OF CONTRACT (APR 1984) 61

E.9 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998) 61

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

b. GOVERNMENT: Contract Specialist, Anette Doan

Department of Veterans Affairs

Network Contracting Office 22

4811 Airport Plaza Drive, Suite 600

Long Beach CA 90815

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

[X]

52.232-33, Payment by Electronic Funds Transfer System for Award Management, or

[]

52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] Upon Delivery with Receiving Report and Approved Invoice

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

This is accomplished through the Tungsten Network located at:

https://www.fsc.va.gov/einvoice.asp

5. ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

AMENDMENT NO

DATE

B.2 STATEMENT OF WORK

Salient Characteristics Requirements:

System will meet or exceed VHA IT Security Requirements including but not limited to an established HL7 interface and financial institution level of encryption.

The operating system will be web based thus allowing for access on any computer for retrieval of information provided appropriate log in is accomplished.

System will have the ability to have bi-directional integration between the software and the VA Electronic Health Record (EHR) and MMIS systems thereby bridging the gap between patient care and supply chain. The system should be able to support EHR systems including Epic, Cerner, PICIS, MEDITECH, GIP, Vista, and McKesson, as well as ERP/MMIS systems including PeopleSoft, Lawson, SAP, MEDITECH, GIP, and McKesson.

Vendor must have a Business Associate Agreement (BAA), Authority to Operate (ATO), Memorandum of Understanding /Interconnection Security Agreement (MOU/ISA) and meet all HIPPA compliance standards for transmission and storage of all data, security of all information. Highest level of encryption technology, as aforementioned, to protect all data transmission and storage security protocols. Able to communicate with other VA medical centers as well as the ability for a National and VISN Directors to see all facilities under there preview.

Utilize FDA Alerts and Recalls program that will do automatic data dives to extract out information and alert on any item that is recalled, no matter the status e.g. implanted, location, etc. Providing automated targeted emailed notifications sent to multiple recipients to facilitate the timeliest notification to the Medical Center staff; alerts have to be same, as facility uses this already and does not want to create a duplicate system with differing language or ways to duplicate/confuse and have it done repetitive times over same alert.

System recall and Alert program will retrieve all maintained information associated with that individual implant e.g., item, location (implanted/shelf). Email or text notifications must be able to be sent when recalls are matched to inventory or affected patients, so manual data dives are not necessary.

System redundancy is required for multiple power grids to assure data base is always available and fully functional.

Must offer full initial data front load of all field information; product extraction to be provided by VA. Start-up implementation milestones meet or exceeded within six (6) months of award. License start-up will not be begun until actual system milestone is in place and implanted. Renewal will be one year from the date of actual start usage, which will be mutually agreed upon by vendor and VA.

Ongoing vendor data loads will be accomplished within one hour or less of request; consistency of data.

Each individual access must have personal log on. The log on must include a trackable (see log ins and levels of access/changes) change management review feature/report. System access shall have a tiered access approach for security and control.

Toll Free Hotline service will be available 24/7 for troubleshooting and emergent issues.

System must integrate data that will show ship and receipt, if manufacturer has already established on the GTIN system and be expandable to those joining; facilitate review from ship to receipt view, so validation can be done. This is necessary to assure staff/patient notification is done as timely as possible should a shipment shows delay in transit (leaning forward for supply chain management).

All tissue monitoring will include tissue prep instruction provided and updated by the tissue/implant tracking vendor, in addition to recall and transmission tracking.

Cath Lab (pacemaker) and OR tracking integration will include RFID solution options.

System must provide option to track complete warranty notification process for credit/returns for implant/explant and usage warranty.

Tracking will be to various categories e.g., consigned, owned, etc.

Ability to create a standardized barcode label for all manufacturers that are not currently utilizing GTIN and those that may need scanning capabilities upon receipt.

System will have a fully developed and interactive secure analytics suite with multiple levels of reporting including graphs/charts, and all exportable to at a minimum but not limited to Excel & PDF formats or as an image; multiple outputs to facilitate differing report views/variations for varying audiences.

System will support barcode scanning capabilities for multiple formats of coding e.g., GTIN and all compliant vendors, as they join the mandated technology compliance. Not looking for a separate barcoding system; reduction in labor burden not increases.

System will populate, validate, update and all retain real time, as well as past, including but may not be limited to, FDA, AATB, AOPO, EEBA, HMBANA, and applicable state certifications as required by Joint Commission; support of acceptable business practices with minimum of 10-year history.

System shall integrate with various RFID electronic supply cabinets.

System will have RFID interoperability for integration of RTLS for future expansion of tracking program.

Vendor must have active shipment integrations with major tissue suppliers, including but may not be limited to LifeNet, MTF, Allosource and CTS.

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM NUMBER

DESCRIPTION OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

0001

1.00

BD

______________

_____________

Implant tracking software comprised of: ONE-TIME FEES BUNDLE - UDIT Premium Installation (1 ea)

IRIS SBC Assembly Board (21 ea)

Label Bezel Branding Swap (21 ea)

RFID Tag (15 ea)

Professional Svcs - RFID Cabinet Imp. Conv (1 ea)

LOCAL STOCK NUMBER: ONE-TIME SVCS

0002

1.00

BD

______________

_____________

ANNUAL SUBSCRIPTION FEES, first year only. Includes - UDIT Premium (1 ea)

RFID Maintenance/SVC (21 ea)

GRAND TOTAL

_____________

B.4 DELIVERY SCHEDULE

ITEM NUMBER

QUANTITY

DELIVERY DATE

0001

1.00

0002

1.00

**PLEASE REFER TO RFQ 36C26223Q1730 PDF FOR FULL CLAUSES AND SUBMISSION INFO**