6515--Percutaneous Osseo Integrated Prosthesis (POP) Devices

Closed Solicitation Posted Mar 19, 2024

This opportunity was awarded. See the award notice from May 14, 2024.

Solicitation number: 36C26224Q0825
Agency: Veterans Integrated Service Network 22 Veterans Health Administration, Department of Veterans Affairs
Responses due: Mar 29, 2024, 3:00 PM ET
Set-aside: No set-aside

Opportunity facts

NAICS code: 334510 Electromedical and Electrotherapeutic Apparatus Manufacturing
PSC: 6515 Medical And Surgical Instruments, Equipment, And Supplies
Place of performance: Department of Veterans Affairs VA Cooperative Studies Program Clinical Research Albuquerque NM 87106
Points of contact: Anette Doan anette.doan@va.gov (562) 766-2200

Notice details come from SAM.gov. Updated May 14, 2024.

About this opportunity

Written by GovTribe AI · May 14, 2024

The Department of Veterans Affairs (VA) is seeking to procure Percutaneous Osseo-integrated Prosthesis (POP) devices, associated surgical instrumentation, and ancillary supplies to support a clinical study involving 150 transfemoral amputee participants at up to six VA sites. The vendor will be responsible for manufacturing and shipping the POP devices, instrumentation, and supplies to the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center prior to the study's start. Key requirements include providing POP devices in various sizes, packaging each item number separately, and meeting a 30-day delivery timeframe after contract award. Offers are due by March 29, 2024.

This is a total Service-Disabled Veteran-Owned Small Business (SDVOSB) set-aside solicitation. The estimated value is not provided, but the quantities range from 20 to 300 units across over 90 line items. The place of performance is the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center in Albuquerque, New Mexico.

Notice text

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

334510

1250 Employees

N/A

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

Nichols, Cecil S.

36C26224Q0825

Page 1 of 66

Page 2 of 68

Page 1 of 66

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS 3

B.1 CONTRACT ADMINISTRATION DATA 3

B.2 STATEMENT OF WORK 4

B.3 PRICE/COST SCHEDULE 8

ITEM INFORMATION 8

B.4 DELIVERY SCHEDULE 13

SECTION C - CONTRACT CLAUSES 17

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) 17

C.2 52.204-27 PROHIBITION ON A BYTEDANCE COVERED APPLICATION. 18

C.3 52.212-4 CONTRACT TERMS AND CONDITIONS COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2023) 19

C.4 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS COMMERCIAL ITEMS (JAN 2021) 24

C.5 52.217-6 OPTION FOR INCREASED QUANTITY (MAR 1989) 31

C.6 52.219-14 LIMITATIONS ON SUBCONTRACTING (OCT 2022) 31

C.7 52.232-33 PAYMENT BY ELECTRONIC FUNDS TRANSFER SYSTEM FOR AWARD MANAGEMENT (OCT 2018) 33

C.8 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998) 35

C.9 VAAR 852.219-74 LIMITATIONS ON SUBCONTRACTING MONITORING AND COMPLIANCE (JUL 2018) 35

C.10 VAAR 852.219-78 VA NOTICE OF LIMITATIONS ON SUBCONTRACTING CERTIFICATE OF COMPLIANCE FOR SUPPLIES AND PRODUCTS (SEP 2021) (DEVIATION) 36

C.11 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018) 38

C.12 VAAR 852.247-72 MARKING DELIVERABLES (OCT 2018) 39

C.13 VAAR 852.247-73 PACKING FOR DOMESTIC SHIPMENT (OCT 2018) 39

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS 40

SECTION E - SOLICITATION PROVISIONS 41

E.1 52.212-1 INSTRUCTIONS TO OFFERORS COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2021) 41

E.2 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018) 46

E.3 52.216-1 TYPE OF CONTRACT (APR 1984) 47

E.4 52.233-2 SERVICE OF PROTEST (SEP 2006) 47

E.5 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998) 48

E.6 52.212-2 EVALUATION COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2021) 48

E.7 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAY 2022) (JUL 2020) (DEVIATION) 49

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

CONTRACT TITLE.

Percutaneous Osseo-integrated Prosthesis (POP) Devices

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.

SCOPE.

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

TASKS

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

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.

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

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.

SECURITY REQUIREMENTS.

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

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

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