36C24626Q0694_1.docx

36C24626Q0694

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

36C24626Q0694 08-19-2026 Ricky Farr 757-251-5877 09-08-2026 17:00

EDT

Department of Veterans Affairs Network Contracting Office 6 100 Emancipation Drive Hampton VA 23667 X 339112 1000 Employees N/A X See Statement of Work for Locations

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 It is the Government's intent to solicit for Standard and Custom Surgical Packs for the Fayetteville Coastal Healthcare System All Offerors shall be registered and current in the System for Award Management (SAM) at time of offer submission and active registration until contract award, completion of performance, & final payment.

NO GRAY MARKET MATERIAL WILL BE ACCEPTED. QUOTERS SHALL

PROVIDE AUTHORIZED DISTRIBUTOR LETTERS.

Order as Needed See CONTINUATION Page X X X Cherisse Hall 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 Cherisse Hall

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.

VA Financial Service Center (FSC) Electronic Invoice Presentment and Payment System https://www.fsc.va.gov/einvoice.as

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

B.2 STATEMENT OF WORK

1. Title of Project: Standard and Custom Surgical Procedure Packs

1. SCOPE: There is a need for standard and custom surgical procedure packs that include pack assembly for the Fayetteville VAMC and all VA clinics that are a part of the Fayetteville VA Coastal Healthcare System. The Contractor shall provide all labor, materials, transportation, equipment and supervision, in compliance with federal, state and local regulations, The Contractor shall provide standard and custom surgical packs, ensure timely delivery, manage inventory, and offer customization options to meet the specific requirements of the medical center’s surgical team.

1. BACKGROUND: The Fayetteville VA Coastal Healthcare System requires standard and custom surgical procedure packs needed to perform surgeries and procedures. These custom packs are needed on an as needed basis. Surgical supplies in each type of procedure pack include supplies identified as necessary to conduct several types of procedures. The types of surgical packs required include Minor Ortho Pack, Minor Surgery Pack, Basic Cystoscopy Standard Tray I, Gynecology Laparoscopy Standard Tray, Knee Arthroscopy IV Surgical Standard Tray, Standard Major Laparotomy Tray I, Surgical Instrument Tray and Nail Avulsion Tray 4.

1. PHYSICAL CHARACTERISTICS: The surgical packs must be sterile and appropriately packaged to maintain sterility until the point of use.

1. Standard surgical packs should include commonly used items for general surgical procedures.

1. Custom surgical packs should be specifically tailored to the needs of different surgical procedures as outlined by the medical center’s surgical staff.

1. FUNCTIONAL AND PERFORMANCE CHARACTERISTICS: All surgical packs must comply with applicable FDA regulations and industry standards.

4. The supplied products must have a defect rate of less than 1%.

4. Custom surgical packs must be designed in consultation with the surgical team to ensure they meet exact surgical requirements.

4. Vendors must offer a wide range of customization options to accommodate specific surgical needs.

4. Any expired items in standard or custom packs must be replaced by the vendor at their cost.

1. TRAINING: Vendor shall provide initial training to the medical center staff on the use and management of the surgical packs.

5. Ongoing support and training shall be available as needed to address any changes or updates in the surgical packs or procedures.

1. WARRANTY OF SERVICE:

6. Vendor shall provide a warranty covering defects in materials and workmanship for a period from date of award to the period of performance end date.

6. Warranty services must include prompt replacement of defective items at no additional cost to the medical center.

6. Any expired items in standard or custom packs must be replaced by the vendor at their cost.

1. DELIVERY SCHEDULE: The vendor must ensure timely delivery of surgical packs according to the agreed-upon delivery schedule.

7. Emergency deliveries should be available within a specified timeframe, preferably within 24 hours.

7. Vendor is responsible for inventory management, ensuring continuous availability of necessary surgical packs to avoid any impact on surgical operations.

7. Initial delivery shall occur within 4 -6 weeks of the contract award.

Requests for delivery shall be issued by facsimile or electronic commerce methods, and only by the VA facility Points of Contact, for the Line-Item Series outlined in the Price/Cost Schedule of items identified in the awarded contract.

a. Date of request

b. PO #

c. Line-Item, Description, Quantity Ordered

d. Delivery Location

Place of Delivery:

7. Fayetteville Coastal Health Care (VAMC), 2300 Ramsey Street Fayetteville NC, 28301

7. Fayetteville HCC, 7300 S Raeford Road Fayetteville, NC 28304

1. SPECIFIC MANDATORY TASKS AND ASSOCIATED DELIVERABLES

1. Assembly and Sterilization.

0. 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, manufacturer item number, description of the component, quantity of component, Country of Origin (COO), sterilization date, and, the lot number of the pack and each component in the pack to ensure traceability. The Contractor shall meet the following assembly and sterilization requirements:

The Contractor shall validate the sterilization process with the Association for Advancement of Medical Instrumentation (AAMI) (http://www.aami.org) annually, at a minimum.

All component debris, sterility tests, and residual tests shall be performed by contracted laboratories at Contractor’s expense.

The Contractor shall guarantee prior to sterilization that the products shall be assembled in secure air-controlled rooms, which are accessible only to authorized personnel with proper attire. The contractor shall follow the Healthcare Sterile Processing Association (HSPA) (https://myhspa.org) and/or Association for the Advancement of Medical Instrumentation (AAMI) (http://www.aami.org) guidelines for proper attire.

The Contractor shall follow current International Organization for Standardization (ISO) for sterilization of health care products and be ISO 9001:2015 certified (or equivalent).

The Contractor shall guarantee that all aspects of the assembly, packaging and sterilization adhere to the quality control standards set by the FDA. The Contractor (all entities in the production process) shall be registered with the FDA and remain current for the duration of the contract and undergo routine FDA inspections.

In accordance with the Executive Order (EO) 14057 dated December 8, 2021, (https://www.fedcenter.gov/programs/eo14057/) the Contractor shall consider earth-friendly solutions and provide a program that supports green purchasing. The Contractor shall provide a recycling program for re-usable items that are salvageable and recommend green product components when available.

The Contractor shall ensure there is no re-sterilization of any single-use product for resale to the VA. Re-sterilization of any product is prohibited.

The Contractor shall maintain sterilization services at all times. Sterilization services can be in the form of in-house sterilization or contracted sterilization services; however, the contracted vendor shall have a written contingency plan in place should the primary sterilization service fail, to ensure service is uninterrupted.

The Contractor shall inspect all component products and check for damage and short dates.

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

The Contractor shall have a quality assurance program and quality assurance staff who are familiar with operating room procedures, infection control practices, aseptic techniques, and sterilization methods.

The Contractor shall ensure sterilization sub-contractor(s) are ISO (International Organization for Standardization) 9001:2015, or equivalent certified and follow Association for the Advancement of Medical Instrumentation (AAMI) (http://www.aami.org) standards. The contractor shall ensure sterilization sub-contractor(s) adhere to sterilization standards set-forth by the Healthcare Sterile Processing Association (HSPA) (https://myhspa.org), and/or Association for the Advancement of Medical Instrumentation (AAMI) (http://www.aami.org). Sterilization sub-contractors shall be registered with the FDA and remain current for the duration of the contract and undergo routine FDA inspections. The Contractor shall provide the sterilization subcontractor’s certifications and FDA registration annually.

The Contractor shall provide copies of the standard operating procedures governing batch control, product tracing, component manufacturing lot numbering and written policies and/or procedures on component recalls when requested.

All custom packs shall be free of debris and particulates.

The Contractor shall comply with the most current and updated version of these codes and standards for the entire term of the contract.

1. Components.

0. Component Parts.

0. The Contractor shall ensure that all individual components within the pack are Trade Agreements Act / Trade Agreements (TAA) compliant unless otherwise authorized by the CO to place orders from a non-TAA compliant country.

0. The substitution or changing of these specific items after award would require the changing of instruments or equipment to utilize the alternative item. The Contractor shall highlight the equal/substituted item on the custom pack’s component list/packing label which was approved by the medical center prior to substitution. The Contractor shall assist the facility staff with ordinary questions and information regarding product exchanges and substitutions.

0. All component packaging shall be removed from outer packaging to reduce steps in the operating/procedure room, unless otherwise required by the customer or the component manufacturer.

0. All packs are to use rigid plastic base trays and component 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 or other indicator demonstrating that packs were sterilized and the method of sterilization used shall be affixed to the outer wrap and tray where applicable. All custom packs shall be sterilized in an approved packaging material with a plastic dust cover. Custom packs material shall allow the sterilization of the contents, maintain sterility, and provide a way to remove the contents without contamination. Plastic dust covers shall 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 shall be chosen to allow penetration of the sterilization process, avoid constriction of the package and maintain package integrity.

0. All components must be Latex Free unless specified otherwise by the ordering facility. All packs must be clearly labeled on the outside covering if they contain latex products. All products containing latex must also be clearly labeled individually as containing latex.

0. Pack List – See Price/Cost Schedule

0. Custom Surgical Pack Components Spreadsheet – See Attachment in Section D Minor Ortho Pack Minor Surgery Pack Basic Cystoscopy Standard Tray I Gynecology Laparoscopy Standard Tray Knee Arthroscopy IV Surgical Standard Tray Standard Major Laparotomy Tray I Surgical Instrument Tray Nail Avulsion Tray 4

0. Requirements for gowns and drapes. Gowns and drapes must meet level 4 requirements of the AAMII PB70:2022 Liquid Barrier Classifications and the following criteria.

7. Materials shall be of a soft, memory-free type that precludes shifting of drapes.

7. Material shall be non-abrasive and free of toxic ingredients, non-fast dyes, and noxious odors.

7. Materials shall be non-glare and of a color that minimizes distortion from reflected light.

7. Gowns shall fit and allow freedom of movement.

7. Gowns shall have stockinet cuffs, raglan sleeves and welded or stitched seams.

7. Gowns and drapes shall maintain an environment appropriate to body temperatures.

7. When substitutions are necessary and approved for surgical gowns and drapes, quantitative data shall be available to show that the materials for surgical gowns and drapes provide an effective barrier to microbes. The materials shall meet the American Society for Testing and Materials (ASTM) requirements for barrier protection, including blood borne pathogens, microbial challenge, as well as hydrostatic pressure with resistance to tears, abrasion, and stains. All materials shall be lint-free and meet or exceed the current and future requirements of the National Fire Protection Regulations for flammability in Part 1610 of the Code of Federal Regulations –Standard for the Flammability of Clothing Textiles. Surgical apparel intended to be worn by the healthcare professionals to help protect both the patient and the healthcare worker from transfer of microorganisms, body fluids, and particulate matter. Substitutions shall meet Level 4 requirements of the AAMI PB70:2022 Liquid Barrier Classifications.

0. Requirements for cloth towels. Cloth towels shall be lint free and meet or exceed the current and future requirements for the National Fire Protection Regulations for flammability in Part 1610 of the Code of Federal Regulations – Standard for the Flammability of Clothing Textiles. When substitutions are necessary and approved for cloth towels, x-ray detectable or not, they shall be absorbent, disposable, or towels made of 100% cotton, and pre-washed.

1. Unavailability of Component Parts

1. Should a component become unavailable which will temporarily (short-term) or permanently (long-term) delay the production of the pack(s), the Contractor shall immediately notify the COR, VA PM, and the CO with written notice to follow within (3) calendar days of the situation and the anticipated length of delay.

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

1. List of packs affected by unavailability.

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

1. Contract and Purchase Order number.

1. Reason for unavailability.

1. Length of time the component will be unavailable. If a direct recall was issued, the Contractor shall include the manufacturer disposition instructions and level of recall.

1. Component Short-term Substitution Process: All short-term component substitutions shall require written authorization from the local COR.

2. Any item requiring short-term substitution (less than 90 days) shall first be presented by the Contractor to the appropriate VA facility’s COR.

2. A sample and/or image of the proposed component substitute and complete specifications shall be provided to the facility by the Contractor for VA review.

2. The COR will coordinate and gather input from applicable end users to validate the item as a suitable substitute.

2. If the substitute component(s) is found acceptable by VA, the COR shall provide written approval to the Contractor.

2. All approved substitutes are to be at no additional cost to the Government.

2. If the substitute component(s) is declined by the VA, the COR will provide written notice to the contractor to ship without and the Contractor will provide the facility with a credit for all impacted packs delivered with missing/deleted component(s). (Reference 6.5.3., 6.5.6. and 9.6.)

1. Component Deletions or Long-Term Substitutions.

3. Components that have long-term delays (greater than 90 days) shall be permanently substituted or deleted from the Custom Pack. The Contractor shall work with the impacted facility to determine alternative components that may meet the VA’s needs or discuss permanent removal.

3. All long-term component changes shall require the Contracting Officer’s approval and a contract modification.

3. Any pack with missing components must have its cost adjusted via a credit to reflect the change. In addition, the content listing will clearly identify any missing items approved to be left out by the VA.

3. Component deletions from packs due to unavailability and VA acceptance of an alternative component shall be tracked by the contractor.

3. Component deletions or custom packs delivered with missing components shall not exceed 3% of the total packs delivered in any given month.

3. When an acceptable component substitution is unavailable and VA authorizes a pack to be built without components, the Contractor shall track the component deletions, the price of each component, and the quantity of components deleted for each custom pack. This information shall be supplied as part of the Monthly Substitution Report.

1. 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 CO and COR shall be notified immediately by written notice within five (5) calendar days, if affected by a product recall. The Contractor shall ensure a method of identifying affected packs on the shelf is provided (such as a brightly colored sticker or other visual identifier) within one (1) business day of notification of recall so that VA may mark the existing pack identifying the recalled component(s). The Contractors existing inventory shall 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), the Contractor shall not make substitutions without written authorization from the CO or COR. Pack conversions in the result of a recall shall adhere to the same timelines for change out as all other pack conversions. All replacement components as a result of the recall will be at no additional cost to the Government. The Contractor shall notify National Center for Patient Safety (NCPS) or FDA of recalls, what packs are affected and lot number.

1. Manufacturer Backorders. The Contractor shall notify the CORs, CO, and VA PM of any Manufacturer Backorder (MBO). The status shall clearly state 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 aid the Contractor and sub-contractor, and the participating customers during the MBO period.

1. Tracking Backorders. The Contractor shall track all backorders electronically and ensure backorders are released AUTOMATICALLY once the backorder is resolved. This shall not be a MANUAL process. All backorders shall be electronically managed and auto shipped once replacement packs are assembled and sterilized. The VA will not wait for the pack to be shipped to the distribution center. The Contractor shall ship at the most expedient manner once sterilization is completed. All backorders shall count against the fill rate unless the delay is the cause of the facility/requestor.

1. Exchanges. If a facility receives DAMAGED/CONTAMINATED Packs, they will be returned to the Contractor and NEW Packs shall be shipped using the same PO by the Contractor in exchange for the bad packs to avoid credits for DAMAGE/CONTAMINATION. Facilities will NOT be directed to dispose of these packs locally, they shall be returned, and the Contractor shall be responsible for destruction. If this caused an EMERGENCY shortage for the VA, the Contractor shall ship replacement packs immediately. If it is not an emergency, the Contractor shall ship new packs as soon as the old packs are returned to the vendor. The Contractor shall provide Return Authorization/Shipping labels within four (4) hours of notification.

1. Packaging

8. 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) shall be constructed to ensure acceptance and safe delivery by common carriers to the point of delivery designated by each medical facility. Items shall be packaged adequately to prevent deterioration and damage during shipping, handling, and storage. All components must be Latex Free unless specified otherwise by the ordering facility. All packs must be clearly labeled on the outside covering if they contain latex products. All products containing latex must also be clearly labeled individually as containing latex.

8. Each pack shall have a pack label specifying the manufactured date and sterilization date of the pack and the expiration date of any dated products. This pack label, located inside of each pack, shall contain an itemized listing of all components, as well as any missing items that were approved to be left out by the VA. Pack contents list shall contain item, quantity, and country of origin information. Expiration dating of all custom sterile procedure packs delivered under this program shall have a minimal shelf life of ninety (90) calendar days remaining upon delivery to the Government. Prior written approval by the medical facility COR is required before delivery of short-dated products.

8. Each pack shall have a separate label on the outside of the pack that includes the name of the VA ordering facility, the VA facility number, the custom pack name, and pack expiration date.

8. All outer shipping packages shall contain the complete contract number and purchase order (PO) number in addition to the shipping address.

8. A packing slip shall be enclosed with each shipment indicating the contract number, purchase order number, description of items, complete stock/tray number, accurate unit of measure, quantity ordered, quantity shipped.

8. Package content quality is the responsibility of the 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 or disposed of with the vendor’s approval. Upon notification of a defective pack, the contractor shall issue a replacement or credit/refund within five (5) business days of receipt of the notification. The decision to receive a replacement or credit/refund shall be made by the ordering officer or COR.

1. Quality Assurance

9. The Contractor shall ensure internal and external manufacturing facilities are registered and in good standing with the Food and Drug Administration (FDA), maintain current ISO certification for Sterilization of health care products, CEN (European Committee for Standardization), and follow Association for Advancement of Medical Instrumentation (AAMI) and Association of Operating Room Nurses (AORN) or other Industry standards that shall be met.

9. Upon request from the PM or COR, the Contractor shall provide certification(s) from the manufacturer showing each BOM component is certified as a U.S.-made or a designated country end-product (FAR Part 25.003 - Caribbean Basin country, World Trade Organization Government Procurement Agreement (WTO GPA) country, Free Trade Agreement (FTA) country, or least developed country).

9. The Contractor shall utilize a “Quality System Program” to prevent non-conformances at all product/service stages from design through distribution. The “Quality System Program” is designed to comply with the requirements of ISO 9001:2015, 21 CFR 820 (Code of Federal Regulations), EN 46001, or equivalent and United States regulations regarding the sales and distribution of medical products. At a minimum ISO 9001:2015 Certification shall be available and continuously maintained throughout the duration of the contract.

9. The custom sterile procedure pack shall adhere to the following ISO standards in the manufacturing of the packs:

3. Product specifications shall include images, bills of material, biological evaluations, component specification, identification of critical design and process parameters and how the parameter shall be met.

3. Production process specifications shall include the appropriate equipment specification, production methods, production procedures, compatibility of the design with current systems and equipment.

3. Packaging and labeling specifications, including methods of processes used.

3. Sterilization requirements and methods.

3. Testing requirements and methods.

9. Contractor shall develop and maintain its own quality control program / inspection plan that assures compliance with all requirements of this contract.

9. 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 or replace, at the Contractor’s expense, any faults or omissions discovered by the inspection of the third party within fifteen (15) calendar days when notified by the CO.

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

MINOR ORTHO PACK

PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

MINORY SURGERY PACK

BASIC CYSTOSCOPY STANDARD TRAY 1

GYNECOLOGY LAPAROSCOPY STANDARD TRAY

KNEE ARTHROSCOPY IV SURGICAL STANDARD TRAY

STANDARD MAJOR LAPAROTOMY TRAY 1

FHCC Surgical Instrument Tray

FHCC Nail Avulsion Tray 4

3624626Q0694

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SECTION C - CONTRACT CLAUSES

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.1 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

https://www.acquisition.gov/browse/index/far https://www.va.gov/oal/library/vaar/

(End of Clause)

C.2 52.222-90 ADDRESSING DEI DISCRIMINATION BY FEDERAL CONTRACTORS (DEVIATION APR 2026) (a)Definitions. As used in this clause— Program participation means membership or participation in, or access or admission to: training, mentoring, or leadership development programs; educational opportunities; clubs; associations; or similar opportunities that are sponsored or established by the contractor or subcontractor.

Racially discriminatory diversity, equity, and inclusion (DEI) activities means disparate treatment based on race or ethnicity in the recruitment, employment (e.g., hiring, promotions), contracting (e.g., vendor agreements), program participation, or allocation or deployment of an entity's resources.

(b) In connection with the performance of work under this contract, the Contractor agrees as follows:

(1) The Contractor will not engage in any racially discriminatory DEI activities;

(2) The Contractor will furnish all information and reports, including providing access to books, records, and accounts, as required by the Contracting Officer, for purposes of ascertaining compliance with this clause;

(3) In the event of the Contractor's or a subcontractor's noncompliance with this clause, this contract may be canceled, terminated, or suspended in whole or in part, and the Contractor or subcontractor may be declared ineligible for further Government contracts;

(4) The Contractor will report any subcontractor's known or reasonably knowable conduct that may violate this clause to the Contracting Officer and take any appropriate remedial actions directed by the Contracting Officer; and

(5) The Contractor will inform the Contracting Officer if a subcontractor sues the Contractor and the suit puts at issue, in any way, the validity of this clause.

(6) The Contractor recognizes that compliance with the requirements of this clause are material to the Government's payment decisions for purposes of 31 U.S.C. 3729(b)(4).

(c) The Contractor must include the substance of this clause, including this paragraph (c), in subcontracts at any tier, including those for commercial products and commercial services, except those where the place of delivery or performance is outside the United States.

(End of Clause)

C.3 52.240-91 SECURITY PROHIBITIONS AND EXCLUSIONS (NOV 2025) (DEVIATION)

(a) Definitions. As used in this clause— American Security Drone Act-covered foreign entity means an entity included on a list that the Federal Acquisition Security Council (FASC) develops and maintains and publishes in the System for Award Management (SAM) at https://www.sam.gov (section 1822 of Pub. L. 118-31, 41 U.S.C. 3901 note prec.).

Backhaul means intermediate links between the core network, or backbone network, and the small subnetworks at the edge of the network (e.g., connecting cell phones/towers to the core telephone network). Backhaul can be wireless (e.g., microwave) or wired (e.g., fiber optic, coaxial cable, Ethernet).

Covered application means the social networking service TikTok or any successor application or service developed or provided by ByteDance Limited or an entity owned by ByteDance Limited.

Covered article, as defined in 41 U.S.C. 4713(k), means:

(1) Information technology, as defined in 40 U.S.C. 11101, including cloud computing services of all types;

(2) Telecommunications equipment or telecommunications service, as those terms are defined in section 3 of the Communications Act of 1934 (47 U.S.C. 153);

(3) The processing of information on a Federal or non-Federal information system, subject to the requirements of the Controlled Unclassified Information program (see 32 CFR part 2002); or

(4) Hardware, systems, devices, software, or services that include embedded or incidental information technology.

Covered foreign country means The People’s Republic of China.

Covered telecommunications equipment or services means—

(1) Telecommunications equipment produced by Huawei Technologies Company or ZTE Corporation (or any subsidiary or affiliate of such entities);

(2) For the purpose of public safety, security of Government facilities, physical security surveillance of critical infrastructure, and other national security purposes, video surveillance and telecommunications equipment produced by Hytera Communications Corporation, Hangzhou Hikvision Digital Technology Company, or Dahua Technology Company (or any subsidiary or affiliate of such entities);

(3) Telecommunications or video surveillance services provided by such entities or using such equipment; or

(4) Telecommunications or video surveillance equipment or services produced or provided by an entity that the Secretary of Defense, in consultation with the Director of National Intelligence or the Director of the Federal Bureau of Investigation, reasonably believes to be an entity owned or controlled by, or otherwise connected to, the government of a covered foreign country.

Critical technology means—

(1) Defense articles or defense services included on the United States Munitions List set forth in the International Traffic in Arms Regulations under subchapter M of chapter I of title 22, Code of Federal Regulations;

(2) Items included on the Commerce Control List set forth in Supplement No. 1 to part 774 of the Export Administration Regulations under subchapter C of chapter VII of title 15, Code of Federal Regulations, and controlled—

(i) Pursuant to multilateral regimes, including for reasons relating to national security, chemical and biological weapons proliferation, nuclear nonproliferation, or missile technology; or

(ii) For reasons relating to regional stability or surreptitious listening;

(3) Specially designed and prepared nuclear equipment, parts and components, materials, software, and technology covered by part 810 of title 10, Code of Federal Regulations (relating to assistance to foreign atomic energy activities);

(4) Nuclear facilities, equipment, and material covered by part 110 of title 10, Code of Federal Regulations (relating to export and import of nuclear equipment and material);

(5) Select agents and toxins covered by part 331 of title 7, Code of Federal Regulations, part 121 of title 9 of such Code, or part 73 of title 42 of such Code; or

(6) Emerging and foundational technologies controlled pursuant to section 1758 of the Export Control Reform Act of 2018 (50 U.S.C. 4817).

FASC-prohibited unmanned aircraft system means an unmanned aircraft system manufactured or assembled by an American Security Drone Act—covered foreign entity.

FASCSA order means any of the following orders issued under the Federal Acquisition Supply Chain Security Act (FASCSA) requiring removing covered articles from executive agency information systems or excluding one or more named sources or named covered articles from executive agency procurement actions, as described in 41 CFR 201-1.303(d) and (e):

(1) The Secretary of Homeland Security may issue FASCSA orders that apply to civilian agencies, to the extent not covered by paragraph (2) or (3) of this definition. This type of FASCSA order may be referred to as a Department of Homeland Security (DHS) FASCSA order.

(2) The Secretary of Defense may issue FASCSA orders that apply to the Department of Defense (DoD) and national security systems other than sensitive compartmented information systems. This type of FASCSA order may be referred to as a DoD FASCSA order.

(3) The Director of National Intelligence (DNI) may issue FASCSA orders that apply to the intelligence community and sensitive compartmented information systems, to the extent not covered by paragraph (2) of this definition. This type of FASCSA order may be referred to as a DNI FASCSA order.

Information technology, as defined in 40 U.S.C. 11101(6)—

(1) Means any equipment or interconnected system or subsystem of equipment, used in the automatic acquisition, storage, analysis, evaluation, manipulation, management, movement, control, display, switching, interchange, transmission, or reception of data or information by the executive agency, if the equipment is used by the executive agency directly or is used by a contractor under a contract with the executive agency that requires the use—

(i) Of that equipment; or

(ii) Of that equipment to a significant extent in the performance of a service or the furnishing of a product;

(2) Includes computers, ancillary equipment (including imaging peripherals, input, output, and storage devices necessary for security and surveillance), peripheral equipment designed to be controlled by the central processing unit of a computer, software, firmware and similar procedures, services (including support services), and related resources; but

(3) Does not include any equipment acquired by a Federal contractor incidental to a Federal contract.

Intelligence community, as defined by 50 U.S.C. 3003(4), means the following—

(1) The Office of the Director of National Intelligence;

(2) The Central Intelligence Agency;

(3) The National Security Agency;

(4) The Defense Intelligence Agency;

(5) The National Geospatial-Intelligence Agency;

(6) The National Reconnaissance Office;

(7) Other offices within the Department of Defense for the collection of specialized national intelligence through reconnaissance programs;

(8) The intelligence elements of the Army, the Navy, the Air Force, the Marine Corps, the Coast Guard, the Federal Bureau of Investigation, the Drug Enforcement Administration, and the Department of Energy;

(9) The Bureau of Intelligence and Research of the Department of State;

(10) The Office of Intelligence and Analysis of the Department of the Treasury;

(11) The Office of Intelligence and Analysis of the Department of Homeland Security; or

(12) Such other elements of any department or agency as may be designated by the President, or designated jointly by the Director of National Intelligence and the head of the department or agency concerned, as an element of the intelligence community.

Interconnection arrangement means arrangements governing the physical connection of two or more networks to allow the use of another’s network to hand off traffic where it is ultimately delivered (e.g., connecting a customer of telephone provider A to a customer of telephone company B) or sharing data and other information resources.

Kaspersky Lab-covered article means any hardware, software, or service that—

(1) Is developed or provided by a Kaspersky Lab-covered entity;

(2) Includes any hardware, software, or service developed or provided in whole or in part by a Kaspersky Lab-covered entity; or

(3) Contains components using any hardware or software developed in whole or in part by a Kaspersky Lab-covered entity.

Kaspersky Lab-covered entity means—

(1) Kaspersky Lab;

(2) Any successor entity to Kaspersky Lab, including any change in name, e.g., “Kaspersky”;

(3) Any entity that controls, is controlled by, or is under common control with Kaspersky Lab; or

(4) Any entity of which Kaspersky Lab has a majority ownership.

National security system, as defined in 44 U.S.C. 3552, means any information system (including any telecommunications system) used or operated by an agency or by a contractor of an agency, or other organization on behalf of an agency—

(1) The function, operation, or use of which involves intelligence activities; involves cryptologic activities related to national security; involves command and control of military forces; involves equipment that is an integral part of a weapon or weapons system; or is critical to the direct fulfillment of military or intelligence missions, but does not include a system that is to be used for routine administrative and business applications (including payroll, finance, logistics, and personnel management applications); or

(2) Is protected at all times by procedures established for information that have been specifically authorized under criteria established by an Executive order or an Act of Congress to be kept classified in the interest of national defense or foreign policy.

Roaming means cellular communications services (e.g., voice, video, data) received from a visited network when unable to connect to the facilities of the home network either because signal coverage is too weak or because traffic is too high.

Sensitive compartmented information means classified information concerning or derived from intelligence sources, methods, or analytical processes, which is required to be handled within formal access control systems established by the Director of National Intelligence.

Sensitive compartmented information system means a national security system authorized to process or store sensitive compartmented information.

Source means a non-Federal supplier, or potential supplier, of products or services, at any tier.

Subsidiary means an entity in which more than 50 percent of the entity is owned directly by a parent corporation or through another subsidiary of a parent corporation.

Substantial or essential component means any component necessary for the proper function or performance of a piece of equipment, system, or service.

Unmanned aircraft means an aircraft that is operated without the possibility of direct human intervention from within or on the aircraft (49 U.S.C. 44801(11)).

Unmanned aircraft system means an unmanned aircraft and associated elements (including communication links and the components that control the unmanned aircraft) that are required for the operator to operate safely and efficiently in the national airspace system (49 U.S.C. 44801(12)).

(b) Prohibitions on providing or using specific products or services in performance of contract. Unless a waiver or exception applies, the Contractor is prohibited from providing any products or services to the Government or using in the performance of the contract any of the following:

(1) A covered application on any information technology owned or managed by the Government, or on any information technology used or provided by the Contractor under this contract, including equipment provided by the Contractor’s employees (section 102 of Division R of the Consolidated Appropriations Act, 2023 (Pub. L. 117-328));

(2) A Kaspersky Lab-covered article (Section 1634 of Division A of the National Defense Authorization Act for Fiscal Year 2018 (Pub. L. 115-91));

(3) Covered telecommunications equipment or services used as a substantial or essential component of any system, or as critical technology as part of any system (paragraphs (a)(1)(A) of section 889 of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L. 115-232)). This does not prohibit contractors from providing—

(i) A service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or

(ii) Telecommunications equipment that cannot route or redirect user data traffic or cannot permit visibility into any user data or packets that such equipment transmits or otherwise handles.

(c) Prohibition on unmanned aircraft systems manufactured or assembled by American Security Drone Act—covered foreign entities.

(1) Prohibition. The Contractor is prohibited from—

(i) Delivering any FASC-prohibited unmanned aircraft system, which includes unmanned aircraft (i.e., drones) and associated elements (sections 1823 and 1826 of American Security Drone Act of 2023, within the National Defense Authorization Act for Fiscal Year 2024, Pub. L. 118-31, Div. A, Title XVIII, Subtitle B, 41 U.S.C. 3901 note prec.);

(ii) On or after December 22, 2025, operating a FASC-prohibited unmanned aircraft system in the performance of the contract (section 1824 of Pub. L. 118-31); and

(iii) On or after December 22, 2025, using Federal funds to procure or operate a FASC-prohibited unmanned aircraft system (section 1825 of Pub. L. 118-31).

(2) Procedures. The Contractor shall search SAM for the FASC-maintained list of American Security Drone Act—covered foreign entities before proposing, or using in performance of the contract, any unmanned aircraft system. Also, the Contractor shall ensure any effort or expenditure associated with a FASC-prohibited unmanned aircraft system is consistent with a corresponding exemption, exception, or waiver determination expressly stated in the contract.

(3) Exemptions, exceptions, and waivers. The prohibitions in paragraph (c) of this clause do not apply where the agency has determined an exemption, exception, or waiver applies,…