36C26224Q0825_2.docx

DOCX document 60 KB Posted Mar 19, 2024

Attached to: 6515--Percutaneous Osseo Integrated Prosthesis (POP) Devices
Solicitation number: 36C26224Q0825
Issued by: Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 22

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Written by GovTribe AI · Mar 20, 2024

This is a solicitation for Percutaneous Osseo-integrated Prosthesis (POP) devices and associated surgical instrumentation to support a clinical study involving 150 veterans. The Department of Veterans Affairs' Clinical Research Pharmacy Coordinating Center requires POP devices in various sizes, multiple components implanted in a two-stage procedure, and surgical instrumentation for implantation across six VA sites. Offerors must provide pricing for over 90 POP device part numbers and instrumentation items. The delivery date is 30 days after award. The acquisition is set aside for veteran-owned small businesses. Responses are due by March 29, 2024.

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SUBJECT*

Percutaneous Osseo Integrated Prosthesis (POP) Devices

GENERAL INFORMATION

CONTRACTING OFFICE’S ZIP CODE*

90815

SOLICITATION NUMBER*

36C26224Q0825

RESPONSE DATE/TIME/ZONE

03-29-2024 12PM PACIFIC TIME, LOS ANGELES, USA

ARCHIVE

30 DAYS AFTER THE RESPONSE DATE

RECOVERY ACT FUNDS

SET-ASIDE

PRODUCT SERVICE CODE*

6515

NAICS CODE*

334510

CONTRACTING OFFICE ADDRESS

Department of Veterans Affairs

Network Contracting Office 22 4811 Airport Plaza Drive Suite 600 Long Beach CA 90815

POINT OF CONTACT*

Contract Specialist Anette Doan Anette.Doan@va.gov

PLACE OF PERFORMANCE

ADDRESS

Department of Veterans Affairs

VA Cooperative Studies Program Clinical Research

Pharmacy Coordinating Center

2401 Centre Avenue, SE

Albuquerque NM

POSTAL CODE

87106-4180

COUNTRY

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

Combined Synopsis/Solicitation Notice Combined Synopsis/Solicitation Notice

DESCRIPTION

*= Required Field

Combined Synopsis/Solicitation Notice

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

36C26224Q0825 03-18-2024 Doan, Anette 562-766-2200 03-29-2024

12PM

PDT

36C262 Department of Veterans Affairs Network Contracting Office 22 4811 Airport Plaza Drive Suite 600 Long Beach CA 90815 X 334510 1250 Employees N/A X 36C501 Department of Veterans Affairs Network Contracting Office 22 4811 Airport Plaza Drive Suite 600 Long Beach CA 90815 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

1866-372-7141 See CONTINUATION Page

PLEASE ENSURE THE FOLLOWING INFORMATION IS REFERENCED

ITEM SCHEDULE, SALIENT CHARACTERISTICS, AND ALL CLAUSES

VENDORS SHALL SHOW CLEAR, COMPELLING, AND CONVINCING

EVIDENCE

THAT ALL “EQUAL TO ITEMS” MEET ALL REQUIRED SALIENT

CHARACTERISTICS IAW FAR 52.211-6 – BRAND NAME OR EQUAL.

AFTER RECEIPT OF ORDER (ARO): 30 CALENDAR DAYS

THIS IS A TOTAL SDVOSB SET-ASIDE SOLICITATION

QUOTES MUST BE SUBMITTED VIA EMAIL TO

ANETTE.DOAN@VA.GOV

QUOTES MUST BE VALID FOR AT LEAST 60 DAYS

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

MARCH 22, 2024.

OFFERS TO THIS SOLICITATION SHALL BE E-MAILED

NO LATER THAN 12:00 PM PDT ON

MARCH 29, 2024

See CONTINUATION Page X X X X Nichols, Cecil S.

Page 1 of Table of Contents No table of contents entries found.

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: TBD MENT: Contracting Officer 36C262 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 and Acceptance

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

1. CONTRACT TITLE.

Percutaneous Osseo-integrated Prosthesis (POP) Devices

2. BACKGROUND.

The VA Cooperative Studies Program, Clinical Research Pharmacy Coordinating Center (CRPCC) has a requirement to source and distribute Percutaneous Osseointegrated Prosthesis (POP) devices, associated surgical instrumentation, and ancillary supplies to support clinical study CSP#2017, A Prospective, Pivotal Study to Characterize the Efficacy and Safety of a Percutaneous Osseointegrated Prosthesis. This study will involve 150 participants (≥ 12 months post transfemoral amputation) to be implanted over a 2-year period at up to 6 VA sites. Each participant’s remaining amputated femur and limb will vary in dimension, and thus requires the procurement of a variety of sizes of POP devices. Furthermore, each POP device requires multiple components which are implanted in a 2-stage procedure four to six weeks apart. Lastly, this project requires procurement of surgical instrumentation for all sites to properly perform safe, sterile, and high-precision surgeries for device implantation; hence, vendor must have FDA approval.

The CRPCC will receive all materials for this study in the prespecified quantities at the start of CSP#2017.

3. SCOPE.

The vendor will manufacture and ship the POP devices, associated instrumentation, and ancillary supplies to the CRPCC prior to study startup.

4. TASKS

4.1 Task 1: The vendor will provide POP devices as specified in the Deliverables (Item Number List) Section of this document.

4.2 Task 2: Vendor will pack items separated by Item Number (such as box per part number, bag per part number, or other similar packaging so each Item Number is separate) provide a packing list clearly showing Item Number, Description, and Quantity of each Part Number.

4.3 Task 3: The vendor will ship all supplies in industry standard packaging

4.4 Task 4: Due to various FDA regulations and other guidance related to implanted/explanted devices, at the end of the subject study, all unusable POP devices will be returned to the vendor for proper disposition in accordance with current industry guidance.

5. SECURITY REQUIREMENTS.

The C&A requirements do not apply, and a Security Accreditation Package is not required.

6. DELIVERY SCHEDULE AND SHIPPING ADDRESS

Delivery should occur as a single shipment once all items have been manufactured and shipped no later than 30-days after contract award.

Supplies to be shipped to:

VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center CSP#2017 (Attn: Adam Henrie/Jeffrey Huminik) 2401 Centre Avenue, SE Albuquerque, NM 87106-4180

7. DELIVERABLES (Item Number List)

(NOTE: If vendor updates item numbers between the time of contract award and user receipt of shipment, vendor/COR/user will coordinate recording changes.)

Item Number

Item Description

Catgegory

Qty

710-00-015

AKA POP, FEMORAL STEM, SZ 15mm

IMPLANTS

710-00-016

AKA POP, FEMORAL STEM, SZ 16mm

IMPLANTS

710-00-017

AKA POP, FEMORAL STEM, SZ 17mm

IMPLANTS

710-00-018

AKA POP, FEMORAL STEM, SZ 18mm

IMPLANTS

710-00-019

AKA POP, FEMORAL STEM, SZ 19mm

IMPLANTS

710-00-020

AKA POP, FEMORAL STEM, SZ 20mm

IMPLANTS

710-00-021

AKA POP, FEMORAL STEM, SZ 21mm

IMPLANTS

710-00-022

AKA POP, FEMORAL STEM, SZ 22mm

IMPLANTS

710-00-100

AKA POP, STAGE 1 CAP

IMPLANTS

168

710-00-200

AKA POP, POST ASSEMBLY BOLT

IMPLANTS

225

710-00-325

AKA POP, PERCUTANEOUS POST, 25mm

IMPLANTS

100

710-00-335

AKA POP, PERCUTANEOUS POST, 25mm

IMPLANTS

100

710-00-345

AKA POP, PERCUTANEOUS POST, 25mm

IMPLANTS

100

710-01-400

AKA POP, FERRIER PROSTHETIC ADAPTER, NEUTRAL, L

IMPLANTS

710-02-400

AKA POP, FERRIER PROSTHETIC ADAPTER, NEUTRAL, R

IMPLANTS

710-01-409

AKA POP, FERRIER PROSTHETIC ADAPTER, 9mm OFFSET, L

IMPLANTS

710-02-409

AKA POP, FERRIER PROSTHETIC ADAPTER, 9mm OFFSET, R

IMPLANTS

710-01-413

AKA POP, FERRIER PROSTHETIC ADAPTER, 13mm OFFSET, L

IMPLANTS

710-02-413

AKA POP, FERRIER PROSTHETIC ADAPTER, 13mm OFFSET, R

IMPLANTS

710-00-500

AKA POP, DISTAL POST ADAPTER BOLT

IMPLANTS

225

710-00-600

AKA POP, STOMA SHIELD

IMPLANTS

300

710-00-700

AKA POP, DISTAL POST ADAPTER

IMPLANTS

168

805-99-111

AKA POP, STAGE 1 FEMORAL PREP, UPPER TRAY

STAGE 1 FEMORAL PREP

805-01-112

AKA POP, REAMER, 12mm

STAGE 1 FEMORAL PREP

805-01-113

AKA POP, REAMER, 13mm

STAGE 1 FEMORAL PREP

805-01-114

AKA POP, REAMER, 14mm

STAGE 1 FEMORAL PREP

805-01-115

AKA POP, REAMER, 15mm

STAGE 1 FEMORAL PREP

805-01-116

AKA POP, REAMER, 16mm

STAGE 1 FEMORAL PREP

805-01-117

AKA POP, REAMER, 17mm

STAGE 1 FEMORAL PREP

805-01-118

AKA POP, REAMER, 18mm

STAGE 1 FEMORAL PREP

805-01-119

AKA POP, REAMER, 19mm

STAGE 1 FEMORAL PREP

805-01-120

AKA POP, REAMER, 20mm

STAGE 1 FEMORAL PREP

805-01-121

AKA POP, REAMER, 21mm

STAGE 1 FEMORAL PREP

805-01-122

AKA POP, REAMER, 22mm

STAGE 1 FEMORAL PREP

805-01-212

AKA POP, PLANER, 12mm

STAGE 1 FEMORAL PREP

805-01-213

AKA POP, PLANER, 13mm

STAGE 1 FEMORAL PREP

805-01-214

AKA POP, PLANER, 14mm

STAGE 1 FEMORAL PREP

805-01-215

AKA POP, PLANER, 15mm

STAGE 1 FEMORAL PREP

805-01-216

AKA POP, PLANER, 16mm

STAGE 1 FEMORAL PREP

805-01-217

AKA POP, PLANER, 17mm

STAGE 1 FEMORAL PREP

805-01-218

AKA POP, PLANER, 18mm

STAGE 1 FEMORAL PREP

805-01-219

AKA POP, PLANER, 19mm

STAGE 1 FEMORAL PREP

805-01-220

AKA POP, PLANER, 20mm

STAGE 1 FEMORAL PREP

805-01-221

AKA POP, PLANER, 21mm

STAGE 1 FEMORAL PREP

805-01-222

AKA POP, PLANER, 22mm

STAGE 1 FEMORAL PREP

805-99-112

AKA POP, STAGE 1 FEMORAL PREP, LOWER TRAY

STAGE 1 FEMORAL PREP

805-01-001

AKA POP, CANAL FINDER

STAGE 1 FEMORAL PREP

805-01-002

AKA POP, STARTER DRILL

STAGE 1 FEMORAL PREP

805-01-111

AKA POP, REAMER, 11mm

STAGE 1 FEMORAL PREP

805-01-312

AKA POP, BROACH, 12mm

STAGE 1 FEMORAL PREP

805-01-313

AKA POP, BROACH, 13mm

STAGE 1 FEMORAL PREP

805-01-314

AKA POP, BROACH, 14mm

STAGE 1 FEMORAL PREP

805-01-315

AKA POP, BROACH, 15mm

STAGE 1 FEMORAL PREP

805-01-316

AKA POP, BROACH, 16mm

STAGE 1 FEMORAL PREP

805-01-317

AKA POP, BROACH, 17mm

STAGE 1 FEMORAL PREP

805-01-318

AKA POP, BROACH, 18mm

STAGE 1 FEMORAL PREP

805-01-319

AKA POP, BROACH, 19mm

STAGE 1 FEMORAL PREP

805-01-320

AKA POP, BROACH, 20mm

STAGE 1 FEMORAL PREP

805-01-321

AKA POP, BROACH, 21mm

STAGE 1 FEMORAL PREP

805-01-322

AKA POP, BROACH, 22mm

STAGE 1 FEMORAL PREP

805-01-017

AKA POP, STEM IMPACTION DEPTH GAUGE

STAGE 1 FEMORAL PREP

805-01-007

AKA POP, STEM IMPACTOR ADAPTER

STAGE 1 FEMORAL PREP

805-02-501

T-HANDLE, FIXED WITH ZIMMER QUICK CONNECT

STAGE 1 FEMORAL PREP

805-99-121

AKA POP, STAGE 1 INSTRUMENT TRAY

STAGE 1 GENERAL INSTRUMENTS

805-01-003

SLAP HAMMER

STAGE 1 GENERAL INSTRUMENTS

805-01-013

BROACH HANDLE

STAGE 1 GENERAL INSTRUMENTS

805-02-601

T20 TORX DRIVER

STAGE 1 GENERAL INSTRUMENTS

805-99-131

AKA POP, STAGE 2 INSTRUMENT TRAY

STAGE 2 INSTRUMENTS

805-01-004

AKA POP, STOMA BLADE

STAGE 2 INSTRUMENTS

805-01-005

AKA POP, POST LENGTH TRIAL

STAGE 2 INSTRUMENTS

805-01-006

AKA POP, POST IMPACTOR HANDLE

STAGE 2 INSTRUMENTS

805-01-008

AKA POP, COUNTER TORQUE HANDLE

STAGE 2 INSTRUMENTS

805-01-010

AKA POP, POST REMOVAL TOOL, 25mm

STAGE 2 INSTRUMENTS

805-01-011

AKA POP, POST REMOVAL TOOL, 35mm

STAGE 2 INSTRUMENTS

805-01-012

AKA POP, POST REMOVAL TOOL, 45mm

STAGE 2 INSTRUMENTS

805-01-018

AKA POP, FERRIER ADAPTER TRIAL

STAGE 2 INSTRUMENTS

805-02-601

T20 TORX DRIVER

STAGE 2 INSTRUMENTS

805-01-502

T-HANDLE, TORQUE LIMITING WITH 1/4" SQ. ADAPTER

STAGE 2 INSTRUMENTS

805-01-602

T30 TORX DRIVER WITH SQ. QUICK CONNECT

STAGE 2 INSTRUMENTS

805-02-015

2.4 x 152 STEINMANN PIN

STAGE 2 INSTRUMENTS

300

805-02-501

T-HANDLE, FIXED WITH ZIMMER QUICK CONNECT

STAGE 2 INSTRUMENTS

800-01-035

PIN EXTRACTOR (INSERTER)

STAGE 2 INSTRUMENTS

805-88-101

AKA POP, X-RAY TEMPLATE, STAGE 1