36C24626Q0059_1.docx

36C24626Q0059

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

36C24626Q0059 10-08-2025 Kristine Woodbury 757-728-3449 10-24-2025

10:00AM

EDT

Kristine Woodbury Department of Veterans Affairs Network Contracting Office 6 100 Emancipation Drive Hampton

VA

23667 X X 339113 800 Employees N/A X Department of Veterans Affairs Asheville VAMC 1100 Tunnel Rd Asheville

NC

28805 Department of Veterans Affairs Network Contracting Office 6 100 Emancipation Drive Hampton

VA

23667

Department of Veterans Affairs Financial Services Center

PO BOX 149971

Austin

TX

78714-9971 512-460-5049 512-460-5221 X See CONTINUATION Page Custom Surgical Packs for OR for the Asheville VAMC, in Asheville, NC.

Period of Performance: One Year See Price/Cost Schedule in B.2 See Statement of Work in B.4 See Section E1 for Instructions to Offerors.

See CONTINUATION Page X X X Harold L. McQuillia, Jr.

Contracting Officer Table of Contents

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: Contracting Officer 36C246 Kristine Woodbury Department of Veterans Affairs Network Contracting Office 6 100 Emancipation Drive Hampton VA 23667

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

3. INVOICES: Invoices shall be submitted in arrears:

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.

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

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

PACK,SURG,CUSTOM,GENERAL SURGERY,DISP

Contract Period: Base POP Begin: 11-01-2025 POP End: 10-31-2026 PRINCIPAL NAICS CODE: 339113 - Surgical Appliance and Supplies Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

MANUFACTURER PART NUMBER (MPN): SBA23GSVAA

NATIONAL STOCK NUMBER: 6515-00-002-8419

LOCAL STOCK NUMBER: 89-5936.09

PACK,SURG,CUSTOM,PACEMAKER,STER,DISP

POP Begin: 11-01-2025 POP End: 10-31-2026 PRINCIPAL NAICS CODE: 339113 - Surgical Appliance and Supplies Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

MANUFACTURER PART NUMBER (MPN): 89-6131.6

NATIONAL STOCK NUMBER: 9999-00-001-1070

LOCAL STOCK NUMBER: 89-6131.08

PACK HYSTEREOSCOPY

POP Begin: 11-01-2025 POP End: 10-31-2026 PRINCIPAL NAICS CODE: 339113 - Surgical Appliance and Supplies Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

MANUFACTURER PART NUMBER (MPN): 89-11057.02

LOCAL STOCK NUMBER: 570.96

PACK,SURG,CUSTOM,TOTAL KNEE,DISP

POP Begin: 11-01-2025 POP End: 10-31-2026 PRINCIPAL NAICS CODE: 339113 - Surgical Appliance and Supplies Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

MANUFACTURER PART NUMBER (MPN): 89-5796.13

NATIONAL STOCK NUMBER: 6515-00-001-4134

LOCAL STOCK NUMBER: 89-5796.14

PACK,SURG,CUSTOM,CATARACT,DISP

POP Begin: 11-01-2025 POP End: 10-31-2026 PRINCIPAL NAICS CODE: 339113 - Surgical Appliance and Supplies Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

MANUFACTURER PART NUMBER (MPN): 14136

NATIONAL STOCK NUMBER: 6515-00-001-4136

LOCAL STOCK NUMBER: 89-5790.09

PACK CHEST

POP Begin: 11-01-2025 POP End: 10-31-2026 PRINCIPAL NAICS CODE: 339113 - Surgical Appliance and Supplies Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

MANUFACTURER PART NUMBER (MPN): 89-7634

NATIONAL STOCK NUMBER: 9999-00-002-9977

LOCAL STOCK NUMBER: 89-7634.5

PACK CAROTID CVT0124-00

POP Begin: 11-01-2025 POP End: 10-31-2026 PRINCIPAL NAICS CODE: 339113 - Surgical Appliance and Supplies Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

MANUFACTURER PART NUMBER (MPN): 89-5791.8

NATIONAL STOCK NUMBER: 6515-00-001-6383

LOCAL STOCK NUMBER: 89-5791-10

PACK,SURG,CUSTOM VA,ENDOVASCULAR PACK,DISP

POP Begin: 11-01-2025 POP End: 10-31-2026 PRINCIPAL NAICS CODE: 339113 - Surgical Appliance and Supplies Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

MANUFACTURER PART NUMBER (MPN): 89-9555.1

NATIONAL STOCK NUMBER: 9999-00-002-2121

LOCAL STOCK NUMBER: 89-9555.3

PACK OR ANGIOGRAPHY

POP Begin: 11-01-2025 POP End: 10-31-2026 PRINCIPAL NAICS CODE: 339113 - Surgical Appliance and Supplies Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

MANUFACTURER PART NUMBER (MPN): 89-9647

NATIONAL STOCK NUMBER: 9999-00-002-2225

LOCAL STOCK NUMBER: 89-9647.03

PACK ENT

POP Begin: 11-01-2025 POP End: 10-31-2026 PRINCIPAL NAICS CODE: 339113 - Surgical Appliance and Supplies Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

MANUFACTURER PART NUMBER (MPN): SEN23ENVAA

NATIONAL STOCK NUMBER: 6515-00-002-8420

LOCAL STOCK NUMBER: 89-5789.08

PACK CYSTO

POP Begin: 11-01-2025 POP End: 10-31-2026 PRINCIPAL NAICS CODE: 339113 - Surgical Appliance and Supplies Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

MANUFACTURER PART NUMBER (MPN): 89-8679.3

NATIONAL STOCK NUMBER: 9999-00-003-2449

LOCAL STOCK NUMBER: 89-8679.4

PACK HYSTERECTOMY

POP Begin: 11-01-2025 POP End: 10-31-2026 PRINCIPAL NAICS CODE: 339113 - Surgical Appliance and Supplies Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

MANUFACTURER PART NUMBER (MPN): 89-8686.04

NATIONAL STOCK NUMBER: 6515-00-001-7292

LOCAL STOCK NUMBER: 89-8686.04

PACK LOWER EXTREMITY

POP Begin: 11-01-2025 POP End: 10-31-2026 PRINCIPAL NAICS CODE: 339113 - Surgical Appliance and Supplies Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

MANUFACTURER PART NUMBER (MPN): 89-8252

NATIONAL STOCK NUMBER: 6515-00-001-7292

LOCAL STOCK NUMBER: 89-8252.03

PACK,SURG,CUSTOM,TOTAL HIP,DISP

POP Begin: 11-01-2025 POP End: 10-31-2026 PRINCIPAL NAICS CODE: 339113 - Surgical Appliance and Supplies Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

MANUFACTURER PART NUMBER (MPN): ORT-0027-06

NATIONAL STOCK NUMBER: 6515-00-001-4135

LOCAL STOCK NUMBER: 89-5786.10

PACK,SURG,CUSTOM,KNEE ARTHROSCOPY,DISP

POP Begin: 11-01-2025 POP End: 10-31-2026 PRINCIPAL NAICS CODE: 339113 - Surgical Appliance and Supplies Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

MANUFACTURER PART NUMBER (MPN): SOP23KAVAA

NATIONAL STOCK NUMBER: 6515-00-001-8127

LOCAL STOCK NUMBER: 89-5795.7

PACK UPPER EXTREMITY

POP Begin: 11-01-2025 POP End: 10-31-2026 PRINCIPAL NAICS CODE: 339113 - Surgical Appliance and Supplies Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

MANUFACTURER PART NUMBER (MPN): 89-8253

NATIONAL STOCK NUMBER: 6515-00-001-7291

LOCAL STOCK NUMBER: 89-8253.03

PACK,SURG,CUSTOM,SHOULDER ARTHROSCOPY,DISP

POP Begin: 11-01-2025 POP End: 10-31-2026 PRINCIPAL NAICS CODE: 339116 - Dental Laboratories PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

MANUFACTURER PART NUMBER (MPN): SOP23SAVAC

NATIONAL STOCK NUMBER: 6515-00-001-8126

LOCAL STOCK NUMBER: 89-5797.10

TRAY PAIN MANAGEMENT PGYBK

POP Begin: 11-01-2025 POP End: 10-31-2026 PRINCIPAL NAICS CODE: 339113 - Surgical Appliance and Supplies Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

MANUFACTURER PART NUMBER (MPN): 89-8825

NATIONAL STOCK NUMBER: 9999-00-003-6001

LOCAL STOCK NUMBER: 89-8825.3

PACK,SURG,CUSTOM,CATH LAB,CCAVF,STER,DISP

POP Begin: 11-01-2025 POP End: 10-31-2026 PRINCIPAL NAICS CODE: 339113 - Surgical Appliance and Supplies Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

MANUFACTURER PART NUMBER (MPN): 89-8764.05

NATIONAL STOCK NUMBER: 6515-00-000-5351

LOCAL STOCK NUMBER: 89-8764.05

B.3 DELIVERY SCHEDULE

1100 Tunnel Road Asheville, NC 28805

USA

B.4 STATEMENT OF WORK

1.0 BACKGROUND

This is a firm-fixed price contract, under which the contractor shall provide for the production and delivery of individualized custom procedure packs to be utilized by the VA Asheville Medical Center (Charles George VA Medical Center) in Asheville, North Carolina. The Custom Sterile Procedure Pack Program will include pack assembly/manufacture, sterilization, quality assurance, and packaging, contractor electronic communication ordering reporting, and delivery. Orders will be made for the custom trays as identified in Contract/Solicitation Attachment A – Pack Contents. All aspects of pack assembly, packaging and sterilization must adhere to the quality control standards set by the FDA.

2.0 SCOPE

The Contractor shall provide all labor, materials, transportation, equipment and supervision, in compliance with federal, state and local regulations, to provide a Custom Sterile Procedure Pack program for the Charles George Medical Center.

3.0 ORDERING

The delivery order will be fully-funded within the limitations of fiscal law for Government contracts and the financial regulations of the Veteran’s Health Administration. Orders will be made in accordance with the “Ordering Procedures” found in paragraph 4 of this Statement of Work.

4.0 ORDERING PROCEDURES

4.1. Requests for delivery shall be issued by facsimile or electronic commerce methods, and only by the VA facility Points of Contact, for the CLIN Series outlined in the schedule of items identified in the awarded contract.

4.2. Requests for delivery shall contain at a minimum the following information:

4.2.1. Date of order;

4.2.2. CLIN, Description, Quantity, Unit Price, and Total Amount;

4.2.3. Delivery or Schedule; and

4.2.4. Place of Delivery

4.3. Upon receiving a request for delivery from the Facility POC, the Contractor shall deliver within two (2) calendar days for standard deliveries and within twenty-four (24) hours for emergency deliveries, unless otherwise stated in the delivery order.

4.4 The Contractor shall have full-time representation to receive requests for delivery. The Government shall place delivery orders to the following: (Offeror to complete)

a. Contact Person: __________________________

b. Telephone Number: __________________________

c. Fax Number __________________________

d. Department __________________________

e. Address __________________________

5.0 PRODUCTION AND SUPPLY

5.1 The Government requires the Contractor to undertake production of such quantities of the product as are necessary to reasonably assure the Government of an uninterrupted supply of the product based upon an anticipated monthly usage. The Government may not obligate funds for product in inventory or production whenever the contract is terminated. The Contractor shall complete component pack changes within thirty (30) days. Due to the possible need for changes, the Government shall be obligated to only a thirty (30) day supply of packs manufactured at the time of the change acceptance and not exceeding the current fiscal obligation time period. In the event the Government terminates the contract, the Government will not be held responsible to procure the additional inventory. In the event of component changes in any pack, the Government agrees to purchase up to a maximum thirty (30) day usage of the current pack composition before the new pack composition is shipped.

5.2. Changes to Composition/Components of Procedure Trays

5.2.1. The Charles George Medical Center may change individual component parts of the tray/pack after an initial thirty (30) days of usage. Pricing and recommended requested changes will be forwarded to the Contractor by the Facility POC. The Contractor shall be required to consider all component part changes and provide a price estimate of each item to be changed. The price proposal will include price plus an estimate for credit for deleted items. In accordance with FAR clause 52.212-4(d), changes may be made only by written agreement of the parties. Only the Contracting Officer has the authority to make changes to the contract. Changes will be made by contract modification/supplemental agreement.

5.2.2. A Pack Change Worksheet shall be utilized for all pack changes. The change form shall include all of the components, quantity and manufacturer detail for the affected pack, including added items and subtracted items. The format of this form is at the discretion of the contractor, to be approved after award or at time of use.

5.2.3. The sales representative (or equivalent) shall supply the Facility POC with the completed change form. With the agreement of the two parties, each shall sign the change form.

5.2.4. The signed change form shall be forwarded to the Contracting Officer for approval.

5.2.5. Once approved by the Contracting Officer, the Contracting Officer shall issue a contract modification/supplemental agreement; the change shall be submitted to the Contractor for the next production run of that pack.

5.2.6. The Contractor shall provide the facility with an electronic inventory report each month, which details: the number of packs on order, the current forecast, the three month average usage, the six month average usage, the number of packs per case, and the cost of the pack. Trends must be communicated between the sales representative and the Facility POC with a mutual determination to adjust inventory levels.

5.2.7. The arrangement of the component parts in the tray/pack shall be coordinated by both the designees and the Facility POC. This coordination shall be prior to production by the Contractor.

5.2.8. Substitutions of items shall not be made without prior approval, in writing, to the Facility POC and approved by the Contracting Officer via contract modification.

5.2.9. The Contractor’s Quality Assurance shall verify changes and ensure the product meets the Government specification. When additions or deletions occur, the Contractor shall provide the Contracting Officer with the costs of each individual component added or deleted at the time of the change or before written authorization by the Contracting Officer.

5.2.10. It is reasonable to expect usage and/or requirements may change during the contract period. The Government reserves the right to negotiate with the Contractor to add and/or delete item(s) to pack components.

5.2.11. If for any reason the Contractor is unable to deliver the agreed upon packs, the contractor will provide (12) hour notice to the Facility POC. The contractor will find an alternative source and initiate a backup plan.

6.0 DELIVERY REQUIREMENTS

6.1. All deliveries will be made FOB Destination to the Charles George Medical Center. Supplies hall be delivered to the destination warehouse unloading platform, or receiving dock, at the expense of the Contractor, except in the case of certain emergency orders. The Government shall not be liable for any delivery, storage, demurrage, accessorial, or other charges involved before the actual delivery (or “constructive placement” as defined in carrier tariffs) of the supplies to the destination. If motor carrier (including “piggyback”) is used, supplies shall be delivered to truck tailgate at the unloading platform of the consignee, except when the supplies delivered meet the requirements of Item 568 of the National Motor Freight Classification for “heavy or bulky freight.” When supplies meeting the requirements of the referenced Item 568 are delivered, unloading (including movement to the tailgate) shall be performed by the consignee, with assistance from the truck driver, if requested. If the contractor uses freight forwarded for less than carload shipments, the contractor shall ensure that the carrier will furnish tailgate delivery, when required, if transfer to truck is required to complete delivery to consignee.

6.2. Pack deliveries shall be made within two (2) calendar days after receipt of order (ARO).

6.3. The contractor shall maintain, at a minimum, a 97% fill rate for all orders. Fill rates are calculated as described below. The contractor shall furnish fill rate reports quarterly to the contracting officer and the contracting officer shall independently verify the contractor’s fill rate based on utilization data.

6.4. Fill-Rate Calculation. The contractor shall individually calculate the fill rate on a quarterly basis, based only on those packs ordered by the medical center, for which the contractor has been authorized to deliver. The Fill-Rate Level will be calculated as follows:

6.5. Fill Rate = Packs accepted by the Government / (Total Packs ordered – Contractual Exceptions)

7.0 PACKAGING

7.1. Unless otherwise specified in the statement of work, the product shall be packed in substantial containers of the type, size and kind commonly used within the industry for this purpose. The container(s) will be constructed as to ensure acceptance and safe delivery by common carriers to the point of delivery designated by each facility. Items must be packaged adequately to prevent deterioration and damage during shipping, handling and storage. All packs must be clearly labeled on the outside covering if they contain latex products. However, all products should be totally latex free, except where authorized by the Facility POC.

7.2. Each pack shall have a label specifying the manufactured date and sterilization date of the pack and the expiration date of any dated products. This label, located inside of each pack, shall also contain an itemized listing of all components, as well as any missing items that were approved to be left out by the Facility POC. Pack contents list must contain item, quantity, and country of origin information. Color coded packs, or some sort of visual cue to distinguish between pack types must be available upon request by the Facility POC at no additional charge. Expiration dating of all custom sterile procedure packs delivered under this program shall have a minimal shelf life of 12 months remaining upon delivery to the Government. Delivery of short-dated products may be approved as situations arise.

7.3. Each pack shall also have a separate label on the outside of the pack that includes the ordering station number and station specified pack name.

7.4. All outer shipping packages shall contain the complete contract number and delivery order number in addition to the shipping address.

7.5. Package content quality is the responsibility of the prime contractor, including items affixed to the outside of the pack (piggyback) and distributed as a part of the pack. Any pack determined to be defective (e.g. contains expired components, sterility has been compromised, etc.), through no fault of the Government, shall be returned to the Contractor at the Contractor’s expense. Full credit or replacement shall be made to the Government.

7.6. The Veterans Health Administration is currently implementing Real Time Location Services (RTLS) throughout its Medical Centers nationwide. One component of the RTLS project includes cardiac catheterization lab supplies using RFID smart cabinets. The purpose is to track those high cost items for increased supply chain visibility and track invasive supplies using a unique device identifier to associate those supplies to a patient through a direct link with our Cart-CL documentation software. The application and use of RFID may expand beyond the CATH lab in future years. Cabinets currently in use include those manufactured by WaveMark, Solstice, and Terso. Where RFID Tags are specified, tags shall be Global Standards 1 (GS1) compliant and must be available in both UHF and HF technologies, as specified by the Charles George Medical Center. Tags will be placed either on specified components or the packs, at the discretion of the ordering facility.

8.0 MANUFACTURING

8.1 STERILIZATION AND ASSEMBLY

8.1.1. The contractor shall ensure an individual lot number for each custom sterile procedure pack is assigned for clear tracking of all packs. The packing list shall include the manufacturer and lot number of each component item to ensure traceability. The contractor shall meet the following assembly and sterilization requirements:

8.1.2. The contractor shall validate the sterilization process, with the Association for Advancement of Medical Instrumentation (AAMI) at a minimum annually. The Contractor shall send the validation to the Contracting Officer within 30 days of annual inspection completion.

8.1.3. All Component debris, sterility tests, and residual tests are to be performed by contract laboratories at contractor’s expense.

8.1.4. The contractor shall guarantee prior to sterilization, the products shall be assembled in secure air controlled rooms, which are accessible only to authorized personnel with proper attire. International Association of Healthcare Central Service Material Management (IAHCSMM) (https://www.iahcsmm.org) and Association for the Advancement of Medical Instrumentation (AAMI) (http://www.aami.org) provide guidelines for proper attire.

8.1.5. The Contractor shall follow current ISO (International Organization for Standardization) for Sterilization of health care product.

8.1.6. The contractor shall guarantee all aspects of the assembly, packaging and sterilization must adhere to the quality control standards set by the FDA. The Contractor (all entities in the production process) shall be registered with the FDA.

8.1.7. In accordance with the Executive Order 13514, dated October 5, 2009, the Contractor should consider earth friendly solutions, and provide a program that supports green purchasing. Contractor should provide a recycling program for re-useable items that are salvageable and recommend green product components when available.

8.1.8. The Contractor shall not provide re-sterilization of any single use product for resale to the VA.

8.1.9. The Contractor shall have in-house sterilization capability or have, the ability to provide sterilization services at all times. The in-house or contract sterilization partners shall be ISO9001:2000 (International Organization for Standardization) certified and undergo routine FDA inspections.

8.1.10. The contractor shall inspect all component products and also check for damage and short dates.

8.1.11. The Contractor shall have continual maintenance performed on all sterilizing equipment.

8.1.12. The contractor shall provide quality assurance staff which shall include personnel familiar with operating room procedures, infection control practices, aseptic techniques and sterilization methods.

9.0 TRAY/BUNDLE CONSTRUCTION

9.1. All component items required for the tray/pack are to be provided by the Contractor. All component packaging will be removed from outer packaging to reduce steps in the operating/procedure room, unless otherwise required by the customer or the component manufacturer.

9.2. All packs are to use hard plastic base trays and components parts to reduce ETO (Ethylene Oxide) residue and eliminate possible particulate contamination from Styrofoam. Biodegradable trays that have the same affect are acceptable. ETO tape/indicator is to be affixed to the outer wrap and tray where applicable. All custom packs should be sterilized in an approved packaging material with a plastic dust cover. Custom packs material must allow the sterilization of the contents, maintain sterility, and provide a way to remove the contents without contamination. Plastic dust covers should be sealed with a method of sealing which results in a complete seal that is tamper evident and allows for ease of aseptic presentation. Accessories used to secure custom packs should be chosen to allow penetration of the sterilization process, avoid constriction of the package and maintain package integrity.

10.0 NONAVAILABILITY OF COMPONENT PARTS

10.1. Should a component part become unavailable which will temporarily or permanently delay the production of the pack(s), the Contractor shall immediately notify the Facility POC and the Contracting Officer by telephone (with written notice to follow within five (5) calendar days) of the situation and the anticipated length of delay.

10.1.1. At a minimum, the unavailability notification shall include the following information:

10.1.1.1. Complete item description, (product and lot number) and/or identification

10.1.1.2. Contract and Delivery Order

10.1.1.3. Reason for unavailability

10.1.1.4. If a direct recall was issued, the contractor shall include the manufacturer disposition instructions and level of recall.

10.2. Recalls: In accordance with the Safe Medical Device Act, (SMDA) the Contractor shall have a documentation system for component product traceability and lot number recordings for product recalls. The Contracting Officer and Facility POC must be notified immediately by telephone (with written notice to follow within five (5) calendar days) if affected by a product recall. The contractor shall also provide a method of identifying affected packs on the shelf such as a brightly colored sticker or other visual identifier within 24 hours so that VA may mark the existing pack identifying the recalled component(s). Vendor existing inventory will be marked using the same method provided to VA staff. If the recalled component is unavailable for further production of the custom sterile procedure pack(s), no substitutions will be made by the Contractor without written authorization of the CO. Pack conversions in the result of a recall shall adhere to the same timelines for change out as all other pack conversions.

10.3. The contractor shall notify the Facility POC and the Contracting Officer of any Manufacturer Backorder (MBO). The status clearly states the reason for any unavailability of component parts due to MBO and shall indicate the length of time for replenishment by product supplier. The government retains the right to investigate the backorder situation to determine the cause of the backorder and to provide assistance to the Custom Sterile Procedure Pack contractor and the participating customers during the MBO period.

10.4. No deletions or substitutions will be made without written authorization from the Contracting Officer or delegated representative. If the component will be out of stock for a prolonged period of time and the using service chooses to have the pack assembled without the product, written authorization must be given by the Contracting Officer or Facility POC. The cost of the pack must be adjusted to reflect the change. In addition, the content listing will clearly identify any missing items approved to be left out by the VA.

11. QUALITY ASSURANCE

11.1. The Custom Sterile Procedure Pack manufacturing facilities must be registered and in good standing with The FDA and ISO9001:2000 certified ISO, CEN (European Committee for Standardization), AAMI (Association of the Advancement of Medical Instrumentation), and AORN (Association of Operating Room Nurses) are other Industry standards that must be met.

11.2. “Quality System Program” to prevent non-conformances at all product/service stages from design through distribution must be utilized. It is designed to comply with the requirements of ISO9001:2000, 21 CFR 820 (Code of Federal Regulations), EN 46001, and United States regulations regarding the sales and distribution of medical products. At a minimum ISO9001:2000 Certification must be available at time of proposal submission, and continuously maintained throughout the duration of the contract.

11.3. The Government may, at its option and expense, request an unrelated third party to inspect the packs provided by the Contractor. The Contractor shall repair, at the Contractor’s cost, any faults or omissions discovered by the inspection of the third party within fifteen (15) days when notified by the Facility POC.

11.4. The Government may, at its option and expense, inspect the contractor’s manufacturing and distribution centers at least annually, within five working days upon request by the Facility POC.

12. DELIVERABLES

13. INVOICING

13.1. The Contractor shall submit one invoice, monthly, for items delivered during the month, under active delivery orders.

13.2. Emergency deliveries will be invoiced under a separate obligation, for deliveries made in the previous month, through obligation to cover costs incurred in a future period, or through the use of Government Purchase Card for individual deliveries, as they occur.

14.GOVERNMENT-FURNISHED EQUIPMENT AND PROPERTY

No Government-furnished equipment or property is provided under this contract.

36C24626Q0059

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SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2023)

(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The Government must exercise its post-acceptance rights—

(1) Within a reasonable time after the defect was discovered or should have been discovered; and

(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.

(b) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims Act (31 U.S.C. 3727). However, when a third party makes payment (e.g., use of the Governmentwide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract.

(c) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties.

(d) Disputes. This contract is subject to 41 U.S.C. chapter 71, Contract Disputes. Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause at Federal Acquisition Regulation (FAR) 52.233-1, Disputes, which is incorporated herein by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.

(e) Definitions. The clause at FAR 52.202-1, Definitions, is incorporated herein by reference.

(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence such as, acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence.

(g) Invoice.

(1) The Contractor shall submit an original invoice and three copies (or electronic invoice, if authorized) to the address designated in the contract to receive invoices. An invoice must include—

(i) Name and address of the Contractor;

(ii) Invoice date and number;

(iii) Contract number, line item number and, if applicable, the order number;

(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading;

(vi) Terms of any discount for prompt payment offered;

(vii) Name and address of official to whom payment is to be sent;

(viii) Name, title, and phone number of person to notify in event of defective invoice; and

(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract.

(x) Electronic funds transfer (EFT) banking information.

(A) The Contractor shall include EFT banking information on the invoice only if required elsewhere in this contract.

(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the Contractor shall have submitted correct EFT banking information in accordance with the applicable solicitation provision, contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer—System for Award Management, or 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management), or applicable agency procedures.

(C) EFT banking information is not required if the Government waived the requirement to pay by EFT.

(2) Invoices will be handled in accordance with the Prompt Payment Act (31 U.S.C. 3903) and Office of Management and Budget (OMB) prompt payment regulations at 5 CFR part 1315.

(h) Patent indemnity. The Contractor shall indemnify the Government and its officers, employees and agents against liability, including costs, for actual or alleged direct or contributory infringement of, or inducement to infringe, any United States or foreign patent, trademark or copyright, arising out of the performance of this contract, provided the Contractor is reasonably notified of such claims and proceedings.

(i) Payment.—

(1) Items accepted. Payment shall be made for items accepted by the Government that have been delivered to the delivery destinations set forth in this contract.

(2) Prompt payment. The Government will make payment in accordance with the Prompt Payment Act (31 U.S.C. 3903) and prompt payment regulations at 5 CFR part 1315.

(3) Electronic Funds Transfer (EFT). If the Government makes payment by EFT, see 52.212-5(b) for the appropriate EFT clause.

(4) Discount. In connection with any discount offered for early payment, time shall be computed from the date of the invoice. For the purpose of computing the discount earned, payment shall be considered to have been made on the date which appears on the payment check or the specified payment date if an electronic funds transfer payment is made.

(5) Overpayments. If the Contractor becomes aware of a duplicate contract financing or invoice payment or that the Government has otherwise overpaid on a contract financing or invoice payment, the Contractor shall—

(i) Remit the overpayment amount to the payment office cited in the contract along with a description of the overpayment including the—

(A) Circumstances of the overpayment (e.g., duplicate payment, erroneous payment, liquidation errors, date(s) of overpayment);

(B) Affected contract number and delivery order number, if applicable;

(C) Affected line item or subline item, if applicable; and

(D) Contractor point of contact.

(ii) Provide a copy of the remittance and supporting documentation to the Contracting Officer.

(6) Interest.

(i) All amounts that become payable by the Contractor to the Government under this contract shall bear simple interest from the date due until paid unless paid within 30 days of becoming due. The interest rate shall be the interest rate established by the Secretary of the Treasury as provided in 41 U.S.C. 7109, which is applicable to the period in which the amount becomes due, as provided in (i)(6)(v) of this clause, and then at the rate applicable for each six-month period as fixed by the Secretary until the amount is paid.

(ii) The Government may issue a demand for payment to the Contractor upon finding a debt is due under the contract.

(iii) Final decisions. The Contracting Officer will issue a final decision as required by 33.211 if—

(A) The Contracting Officer and the Contractor are unable to reach agreement on the existence or amount of a debt within 30 days;

(B) The Contractor fails to liquidate a debt previously demanded by the Contracting Officer within the timeline specified in the demand for payment unless the amounts were not repaid because the Contractor has requested an installment payment agreement; or

(C) The Contractor requests a deferment of collection on a debt previously demanded by the Contracting Officer (see 32.607-2).

(iv) If a demand for payment was previously issued for the debt, the demand for payment included in the final decision shall identify the same due date as the original demand for payment.

(v) Amounts shall be due at the earliest of the following dates:

(A) The date fixed under this contract.

(B) The date of the first written demand for payment, including any demand for payment resulting from a default termination.

(vi) The interest charge shall be computed for the actual number of calendar days involved beginning on the due date and ending on—

(A) The date on which the designated office receives payment from the Contractor;

(B) The date of issuance of a Government check to the Contractor from which an amount otherwise payable has been withheld as a credit against the contract debt; or

(C) The date on which an amount withheld and applied to the contract debt would otherwise have become payable to the Contractor.

(vii) The interest charge made under this clause may be reduced under the procedures prescribed in FAR 32.608-2 in effect on the date of this contract.

(j) Risk of loss. Unless the contract specifically provides otherwise, risk of loss or damage to the supplies provided under this contract shall remain with the Contractor until, and shall pass to the Government upon:

(1) Delivery of the supplies to a carrier, if transportation is f.o.b. origin; or

(2) Delivery of the supplies to the Government at the destination specified in the contract, if transportation is f.o.b. destination.

(k) Taxes. The contract price includes all applicable Federal, State, and local taxes and duties.

(l) Termination for the Government's convenience. The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience. In the event of such termination, the Contractor shall immediately stop all work hereunder and shall immediately cause any and all of its suppliers and subcontractors to cease work. Subject to the terms of this contract, the Contractor shall be paid a percentage of the contract price reflecting the percentage of the work performed prior to the notice of termination, plus reasonable charges the Contractor can demonstrate to the satisfaction of the Government using its standard record keeping system, have resulted from the termination. The Contractor shall not be required to comply with the cost accounting standards or contract cost principles for this purpose. This paragraph does not give the Government any right to audit the Contractor's records. The Contractor shall not be paid for any work performed or costs incurred which reasonably could have been avoided.

(m) Termination for cause. The Government may terminate this contract, or any part hereof, for cause in the event of any default by the Contractor, or if the Contractor fails to comply with any contract terms and conditions, or fails to provide the Government, upon request, with adequate assurances of future performance. In the event of termination for cause, the Government shall not be liable to the Contractor for any amount for supplies or services not accepted, and the Contractor shall be liable to the Government for any and all rights and remedies provided by law. If it is determined that the Government improperly terminated this contract for default, such termination shall be deemed a termination for convenience.

(n) Title. Unless specified elsewhere in this contract, title to items furnished under this contract shall pass to the Government upon acceptance, regardless of when or where the Government takes physical possession.

(o) Warranty. The Contractor warrants and implies that the items delivered hereunder are merchantable and fit for use for the particular purpose described in this contract.

(p) Limitation of liability. Except as otherwise provided by an express warranty, the Contractor will not be liable to the Government for consequential damages resulting from any defect or deficiencies in accepted items.

(q) Other compliances. The Contractor shall comply with all applicable Federal, State and local laws, executive orders, rules and regulations applicable to its performance under this contract.

(r) Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31 U.S.C. 1352 relating to limitations on the use of appropriated funds to influence certain Federal contracts; 18 U.S.C. 431 relating to officials not to benefit; 40 U.S.C. chapter 37, Contract Work Hours and Safety Standards; 41 U.S.C. chapter 87, Kickbacks; 49 U.S.C. 40118, Fly American; and 41 U.S.C. chapter 21 relating to procurement integrity.

(s) Order of precedence. Any inconsistencies in this solicitation or contract shall be resolved by giving precedence in the following order:

(1) The schedule of supplies/services.

(2) The Assignments, Disputes, Payments, Invoice, Other Compliances, Compliance with Laws Unique to Government Contracts, and Unauthorized Obligations paragraphs of this clause;

(3) The clause at 52.212-5.

(4) Addenda to this solicitation or contract, including any license agreements for computer software.

(5) Solicitation provisions if this is a solicitation.

(6) Other paragraphs of this clause.

(7) The Standard Form 1449.

(8) Other documents, exhibits, and attachments

(9) The specification.

(t) [Reserved]

(u) Unauthorized Obligations.

(1) Except as stated in paragraph (u)(2) of this clause, when any supply or service acquired under this contract is subject to any End User License Agreement (EULA), Terms of Service (TOS), or similar legal instrument or agreement, that includes any clause requiring the Government to indemnify the Contractor or any person or entity for damages, costs, fees, or any other loss or liability that would create an Anti-Deficiency Act violation (31 U.S.C. 1341), the following shall govern:

(i) Any such clause is unenforceable against the Government.

(ii) Neither the Government nor any Government authorized end user shall be deemed to have agreed to such clause by virtue of it appearing in the EULA, TOS, or similar legal instrument or agreement. If the EULA, TOS, or similar legal instrument or agreement is invoked through an “I agree” click box or other comparable mechanism (e.g., “click-wrap” or “browse-wrap” agreements), execution does not bind the Government or any Government authorized end user to such clause.

(iii) Any such clause is deemed to be stricken from the EULA, TOS, or similar legal instrument or agreement.

(2) Paragraph (u)(1) of this clause does not apply to indemnification by the Government that is expressly authorized by statute and specifically authorized under applicable agency regulations and procedures.

(v) Incorporation by reference. The Contractor’s representations and certifications, including those completed electronically via the System for Award Management (SAM), are incorporated by reference into the contract.

(End of Clause) ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES Clauses that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

The following clauses are incorporated into 52.212-4 as an addendum to this contract:

C.2 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018)

(a) Definitions. As used in this clause—

(1) Contract financing payment has the meaning given in FAR 32.001;

(2) Designated agency office means the office designated by the purchase order, agreement, or contract to first receive and review invoices. This office can be contractually designated as the receiving entity.