S01 - RFP (36C25919R0099) - Custom Packs (VISN 19) _ 8.02.2021.pdf

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. DUNS: DUNS+4:

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. 2/2012)

PREVIOUS EDITION IS NOT USABLE Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

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

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS 77

36C25919R0099 08-03-2021

Kurt Tanny 303-712-5828 09-02-2021

36C259 Department of Veterans Affairs Network Contracting Office

NCO 19

6162 South Willow Drive, Suite 300 Greenwood Village CO 80111

X 100

X

339113

750 Employees

N/A

X

Department of Veteran Affairs - VISN 19

Multiple Locations See Delivery Schedule

36C259

Network Contracting Office

NCO 19

6162 South Willow Drive, Suite 300 Greenwood Village CO 80111

Financial Service Center PO Box 149971 Austin TX 78714-9971

See CONTINUATION Page

Provide Custom Surgical Sterile Packs / Custom Procedure Trays (CPTs) to multiple VA medical facilities within the VISN 19 footprint in accordance with the Statement of Work

See CONTINUATION Page

X X

36C25919R0099

Table of Contents

SECTION A

A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

B.3 DELIVERY LOCATIONS

B.4 STATEMENT OF WORK

SECTION C - CONTRACT CLAUSES

C.1 52.216-18 ORDERING (AUG 2020)

C.2 52.216-19 ORDER LIMITATIONS (OCT 1995)

C.3 52.216-22 INDEFINITE QUANTITY (OCT 1995)

C.4 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.5 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000) ... 28

C.6 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA

ACQUISITION OF COMMERCIAL ITEMS (APR 2020)

C.7 VAAR 852.219-74 LIMITATIONS ON SUBCONTRACTING—MONITORING AND

COMPLIANCE (JUL 2018)

C.8 VAAR 852.247-71 DELIVERY LOCATION (OCT 2018)

C.9 VAAR 852.247-72 MARKING DELIVERABLES (OCT 2018)

C.10 VAAR 852.247-73 PACKING FOR DOMESTIC SHIPMENT (OCT 2018)

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

C.12 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (JAN 2021) (JUL 2020)

(DEVIATION)

C.13 MANDATORY WRITTEN DISCLOSURES

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS (JUN 2020) 41

PART I – PRICE PROPOSAL (SOLICITATION DOCUMENT SF 1449)

PART 2 – PRODUCT SAMPLE PACKS

PART 3 – STANDARDS OF RESPONSIBILITY

E.2 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (OCT 2020)

E.3 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.4 52.216-1 TYPE OF CONTRACT (APR 1984)

E.5 52.225-6 TRADE AGREEMENTS CERTIFICATE (MAY 2014)

E.6 52.225-18 PLACE OF MANUFACTURE (AUG 2018)

E.7 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.8 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.9 52.212-2 EVALUATION—COMMERCIAL ITEMS (OCT 2014)

E.10 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL ITEMS (FEB 2021) (JUL 2020) (DEVIATION)

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 36C259

Network Contracting Office 19 6162 South Willow Drive, Suite 300

Greenwood Village CO 80111

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

[X] 52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or

[] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] AFTER DELIVERY OF INDIVIDUAL ORDERS

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.

Department of Veterans Affairs Financial Service Center

PO Box 149971 Austin TX 78714-9971

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

AMENDMENT NO DATE

5. CONTRACTING OFFICER RESPONSIBILITIES:

The Contractor shall contact the Contract Officer (CO) on all matters pertaining to administration. Only the CO is authorized to make commitments or issue changes that will affect the price, quantity, delivery or terms of the contract. The CO is responsible for overall compliance with the contract terms and conditions. The Contractor’s designation of representatives to handle certain functions under this contract does not relieve the Contractor of responsibility for contract compliance. Any changes to the designated individual must be provided to the CO, in writing, with the proposed effective date of the change. The following individuals will handle all contract administration issues.

a. GOVERNMENT: Maurice Walker, Contracting Officer

Network Contracting Office 19 6162 South Willow Drive Suite 300 Greenwood Village, CO 80111

Kurt Tanny, Contract Specialist Department of Veterans Affairs Network Contracting Office 19 6162 South Willow Drive Suite 300 Greenwood Village, CO 80111

6. TRADE AGREEMENT CERTIFICATE:

The contractor certifies that each component part (end product) is a U.S. made or designated country end products as defined in the clause of this solicitation entitled “Trade Agreements.”

The TAA provides that the Government may acquire only “U.S.-made or designated country end products.” The Act requires contractors to certify that each end product meets the applicable requirements. “End products” are defined as “those articles, materials and supplies to be acquired for public use. The TAA requires that end products from designated countries be treated the same as U.S.-made products for government procurement purposes, and prohibits the acquisition of end products from other, non-designated countries. As such, the TAA provides an exception to the Buy America Act (“BAA”), which is intended to promote the acquisition of “domestic [US] end products.” See FAR 25.100-102; see also FAR 52.225-1; 52.225-2. The TAA applies a rule-of-origin requirement to the end product being supplied and requires that end products acquired by the Government must be “wholly the growth, product or manufacture” of the U.S. or of a designated country, or “substantially transformed [in the U.S. or a designated country] . . . into a new and different article of commerce with a name, character, or use distinct from that of the article or articles from which it was transformed.” See FAR 25.003.

7. ORDERING:

The warranted Contracting Officer (CO) or the delegated Purchasing Agents are the only individuals that are authorized to place Delivery Orders under this contract.

Participating facilities will normally generate orders in Integrated Funds Distribution Control Point Activity Accounting and Procurement (IFCAP), which will be transmitted via EDI as the required ordering method. Only in the event of emergencies or system failures will the contractor also accept other methods of order placement and order modifications such as, fax, telephone, email and the contractor’s web portal.

1. EDI Order Confirmation: The contractor shall generate EDI order confirmation (EDI 855) to the FSC within two hours after receipt of EDI orders. This EDI transmission will include a confirmation or rejection for each line item on the original order. The contractor may continue to use a Value-Added Network (VAN) for EDI transmission. If they do not have a VAN in place, the contractor shall be required to sign a Business Association Agreement to bypass the VAN and communicate directly with the VA. VA also requires an Interconnection Security Agreement Memorandum of Understanding (ISA/MOU) to establish a direct connection with a contractor.

2. Order Confirmations: At a minimum, the EDI order confirmation will include product number ordered, quantity ordered, unit of issue, delivered unit price, delivery order number, and the American National Standards Institute (ANSI) Reject/Status Codes applicable to the ordered line item.

a. The order confirmation must be in identical sequence to the delivery order placed by the ordering facility. The confirmation shall be communicated via EDI 855. Furthermore, all unfilled or partially filled line items shall be listed on the confirmation request. For the delivered unit price of each supply, the packing list price must be identical to the confirmation price.

1. EDI: These requirements apply unless otherwise indicated. The contractor shall provide their own computer hardware and software necessary to receive and transmit all functions required. The contractor must be capable of and experienced with transmitting/accepting EDI ANSI X12 v5010 transaction sets 850, 855, 856 and 810, at time of proposal submission. The contractor will be required to provide verification of its capability and experience prior to award unless this requirement is waived due to recent demonstrated performance. The contractor shall have EDI interface capabilities to process EDI orders and acknowledge orders in accordance with ANSI ASC X.12M Supply Chain Standard Transaction set:

a. Current transactions:

850 (Purchase Order) 855 (Purchase Order Acknowledgement) 810 (Invoice) 842 (Invoice Status) 856 (Advance Ship Notice)

b. EDI 850 – Purchase Order: This transaction set will go from FSC to the contractor and will be used by the ordering facility to place electronic orders. Specific formatting instruction for EDI 850 will be provided by FSC in an implementation guide.

c. EDI 855 – Purchase Order Acknowledgement: This transaction set will be sent from the contractor to the FSC and will be used to confirm the order. Specific formatting instructions for EDI 855 will be provided by FSC in an implementation guide.

d. EDI 856 – Advance Ship Notice: This transaction set will be sent from the contractor to FSC and will be generated by the contractor at the “pick and pack” stage of the shipment process to provide accurate shipping information to the ordering facility. FSC will forward this transaction to the customer. Specific formatting instructions for EDI 856 will be provided by FSC in an implementation guide.

e. EDI 810 – Electronic Invoice: This transaction set will be used by the contractor to invoice for products delivered.

Specific formatting instructions for the EDI 810 will be provided by the FSC in an implementation guide.

EDI 842 – Invoice Status: This is an optional transaction set available to the contractor which will provide an electronic communication from the FSC to the contractor upon changes or updates to the status of a submitted invoice. Specific formatting instructions for the EDI 842 will be provided by the FSC in an implementation guide.

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

2.00 HR __________________ __________________

Post Award Meeting (2 hours) This is the guarantee minimum amount for the life of this IDIQ contract.

The maximum aggregate ceiling value for this IDIQ contract is $________________ (to be input prior to award). The Government does not guarantee that it will place any order under this contract in excess of the guaranteed minimum award amount.

1.00 YR __________________ __________________

The contractor will be responsible to assemble, distribute, and manage all modification requests for Custom Sterile Surgical Packs in accordance with the Statement of Work.

Ft. Harrison VA Medical Center (VAMC) (Station Number – 436)

The maximum aggregate ceiling value for this IDIQ contract is $________________ (to be input prior to award).

Contract Period: Base POP Begin: 09-28-2021 POP End: 09-27-2022 modification requests for Custom Sterile Surgical Packs in accordance with the Statement of Work.

Billings VAMC (Station Number – 436)

The maximum aggregate ceiling value for this IDIQ contract is $________________ (to be input prior to award).

Contract Period: Base modification requests for Custom Sterile Surgical Packs in accordance with the Statement of Work.

Cheyenne VAMC (Station Number – 442)

The maximum aggregate ceiling value for this IDIQ contract is $________________ (to be input prior to award).

Contract Period: Base modification requests for Custom Sterile Surgical Packs in accordance with the Statement of Work.

Rocky Mountain Regional VAMC (Denver) (Station Number – 554)

The maximum aggregate ceiling value for this IDIQ contract is $________________ (to be input prior to award).

Contract Period: Base modification requests for Custom Sterile Surgical Packs in accordance with the Statement of Work.

Grand Junction VAMC (Station Number – 575)

The maximum aggregate ceiling value for this IDIQ contract is $________________ (to be input prior to award).

Contract Period: Base modification requests for Custom Sterile Surgical Packs in accordance with the Statement of Work.

Jack C. Montgomery VAMC (Muskogee) (Station Number – 623)

The maximum aggregate ceiling value for this IDIQ contract is $________________ (to be input prior to award).

Contract Period: Base

The contractor will be responsible to assemble, distribute, and manage all modification requests for Custom Sterile Surgical Packs in accordance with the Statement of Work.

Oklahoma City VAMC (Station Number – 635)

The maximum aggregate ceiling value for this IDIQ contract is $________________ (to be input prior to award).

Contract Period: Base modification requests for Custom Sterile Surgical Packs in accordance with the Statement of Work.

George E. Wahlen VAMC (Salt Lake City) (Station Number – 660)

The maximum aggregate ceiling value for this IDIQ contract is $________________ (to be input prior to award).

Contract Period: Base modification requests for Custom Sterile Surgical Packs in accordance with the Statement of Work

Ft. Harrison VA Medical Center (VAMC) (Station Number – 436)

Contract Period: Option 1 POP Begin: 09-28-2022 POP End: 09-27-2023 modification requests for Custom Sterile Surgical Packs in accordance with the Statement of Work

Billings VAMC (Station Number – 436)

Contract Period: Option 1 modification requests for Custom Sterile Surgical Packs in accordance with the Statement of Work

Cheyenne VAMC (Station Number – 442)

Contract Period: Option 1 modification requests for Custom Sterile Surgical Packs in accordance with the Statement of Work

Rocky Mountain Regional VAMC (Denver) (Station Number – 554)

Contract Period: Option 1 modification requests for Custom Sterile Surgical Packs in accordance with the Statement of Work

Grand Junction VAMC (Station Number – 575) Contract Period: Option 1 modification requests for Custom Sterile Surgical Packs in accordance with the Statement of Work

Jack C. Montgomery VAMC (Muskogee) (Station Number – 623) Contract Period: Option 1 modification requests for Custom Sterile Surgical Packs in accordance with the Statement of Work

Oklahoma City VAMC (Station Number – 635) Contract Period: Option 1 modification requests for Custom Sterile Surgical Packs in accordance with the Statement of Work

George E. Wahlen VAMC (Salt Lake City) (Station Number – 660) Contract Period: Option 1 modification requests for Custom Sterile Surgical Packs in accordance with the Statement of Work

Ft. Harrison VA Medical Center (VAMC) (Station Number – 436)

Contract Period: Option 2 POP Begin: 09-28-2023 POP End: 09-27-2024 modification requests for Custom Sterile Surgical Packs in accordance with the Statement of Work

Billings VAMC (Station Number – 436)

Contract Period: Option 2 modification requests for Custom Sterile Surgical Packs in accordance with the Statement of Work

Cheyenne VAMC (Station Number – 442)

Contract Period: Option 2 modification requests for Custom Sterile Surgical Packs in accordance with the Statement of Work

Rocky Mountain Regional VAMC (Denver) (Station Number – 554)

Contract Period: Option 2 modification requests for Custom Sterile Surgical Packs in accordance with the Statement of Work

Grand Junction VAMC (Station Number – 575)

Contract Period: Option 2 modification requests for Custom Sterile Surgical Packs in accordance with the Statement of Work

Jack C. Montgomery VAMC (Muskogee) (Station Number – 623) Contract Period: Option 2 modification requests for Custom Sterile Surgical Packs in accordance with the Statement of Work

Oklahoma City VAMC (Station Number – 635) Contract Period: Option 2 modification requests for Custom Sterile Surgical Packs in accordance with the Statement of Work

George E. Wahlen VAMC (Salt Lake City) (Station Number – 660) Contract Period: Option 2 modification requests for Custom Sterile Surgical Packs in accordance with the Statement of Work

Ft. Harrison VA Medical Center (VAMC) (Station Number – 436)

Contract Period: Option 3 POP Begin: 09-28-2024 POP End: 09-27-2025 modification requests for Custom Sterile Surgical Packs in accordance with the Statement of Work

Billings VAMC (Station Number – 436)

Contract Period: Option 3 modification requests for Custom Sterile Surgical Packs in accordance with the Statement of Work

Cheyenne VAMC (Station Number – 442)

Contract Period: Option 3 modification requests for Custom Sterile Surgical Packs in accordance with the Statement of Work

Rocky Mountain Regional VAMC (Denver) (Station Number – 554)

Contract Period: Option 3 modification requests for Custom Sterile Surgical Packs in accordance with the Statement of Work

Grand Junction VAMC (Station Number – 575)

Contract Period: Option 3 modification requests for Custom Sterile Surgical Packs in accordance with the Statement of Work

Jack C. Montgomery VAMC (Muskogee) (Station Number – 623)

Contract Period: Option 3 modification requests for Custom Sterile Surgical Packs in accordance with the Statement of Work

Oklahoma City VAMC (Station Number – 635)

Contract Period: Option 3

The contractor will be responsible to assemble, distribute, and manage all modification requests for Custom Sterile Surgical Packs in accordance with the Statement of Work

George E. Wahlen VAMC (Salt Lake City) (Station Number – 660)

Contract Period: Option 3 modification requests for Custom Sterile Surgical Packs in accordance with the Statement of Work

Ft. Harrison VA Medical Center (VAMC) (Station Number – 436) Contract Period: Option 4 POP Begin: 09-28-2025 POP End: 09-27-2026 modification requests for Custom Sterile Surgical Packs in accordance with the Statement of Work

Billings VAMC (Station Number – 436) Contract Period: Option 4 modification requests for Custom Sterile Surgical Packs in accordance with the Statement of Work

Cheyenne VAMC (Station Number – 442) Contract Period: Option 4 modification requests for Custom Sterile Surgical Packs in accordance with the Statement of Work

Rocky Mountain Regional VAMC (Denver) (Station Number – 554) Contract Period: Option 4 modification requests for Custom Sterile Surgical Packs in accordance with the Statement of Work

Grand Junction VAMC (Station Number – 575) Contract Period: Option 4 modification requests for Custom Sterile Surgical Packs in accordance with the Statement of Work

Jack C. Montgomery VAMC (Muskogee) (Station Number – 623) Contract Period: Option 4 modification requests for Custom Sterile Surgical Packs in accordance with the Statement of Work

Oklahoma City VAMC (Station Number – 635)) Contract Period: Option 4 modification requests for Custom Sterile Surgical Packs in accordance with the Statement of Work

George E. Wahlen VAMC (Salt Lake City) (Station Number – 660) Contract Period: Option 4

GRAND TOTAL __________________

B.3 DELIVERY LOCATIONS

Facility Locations:

Ft. Harrison VA Medical Center (VAMC) (Station Number – 436) 3687 Veterans Drive Fort Harrison, MT 59636

Billings VAMC (Station Number – 436) 1766 Majestic Lane Billings, MT 59711

Cheyenne VAMC (Station Number – 442) 2360 E Pershing Blvd Cheyenne, WY 82001

Rocky Mountain Regional VAMC (Denver) (Station Number – 554) 1700 North Wheeling St.

Aurora, CO 80111

Grand Junction VAMC (Station Number – 575) 2121 North Ave Grand Junction, CO 81501

Jack C. Montgomery VAMC (Muskogee) (Station Number – 623) 1101 Honor Heights Dr.

Muskogee, OK 74401

Oklahoma City VAMC (Station Number – 635) 921 NE 13th St.

Oklahoma City, OK 73104

George E. Wahlen VAMC (Salt Lake City) (Station Number – 660) 500 Foothill Dr.

Salt Lake City, UT 84148

B.4 STATEMENT OF WORK

1. SCOPE

A. The Contractor shall provide all labor, materials, transportation, equipment and supervision, in compliance with federal, state and local regulations, to provide Custom Sterile Surgical Packs/Custom Procedure Tray (CPT) and creation of new packs, as deemed necessary for the participating Government Healthcare facilities.

2. CONTRACTOR SPECIFIC TASKS

A. The Contractor shall provide for each CPT a lot number to allow for clear tracking of all packs and products. The Contractor shall ensure the manufacturer and lot number of each component item is traceable. 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.

B. STERILIZATION REQUIREMENTS

1) The sterilization process (whether on site or off-site/outsourced) used by the contractor, shall be validated on an annual basis. Independent contract laboratories shall perform component bioburden tests, sterility tests, and residual tests. The validation must be sent to the Contracting Officer upon annual inspection.

2) Products shall be assembled in controlled rooms and then sterilized.

3) Pack assembly shall be performed inside an environmentally controlled, limited access room. The room shall be maintained under positive air pressure and all surfaces cleaned. The Contractor shall have a sanitation program that monitors levels of microbial contamination.

4) The Contractor shall be both responsible and liable for the sterility and quality of the product when properly used and handled by the Government.

5) Re-sterilization of any product is prohibited.

6) The Contractor shall either: (a) assemble and sterilize the CPTs in-house and have at least one partner that can assemble and sterilize the CPTs off-site, or (b) if the contractor does not have in-house capability, then the contractor must have at least two facilities off-site that can each perform assembly and sterilization of the CPTs. All assembly-and-sterilization partner facilities must meet all required standards described herein.

7) All component products shall be inspected and checked for damage. There shall be no component or pack that expires within 30 days of delivery.

8) The contractor shall guarantee the serviceability of all sterilizing equipment by either performing or ensuring all required scheduled and unscheduled maintenance is performed.

9) Quality assurance staff shall include personnel familiar with operating room procedures, infection control practices, aseptic techniques and sterilization methods.

C. COMPONENT PARTS

Listings are contained in ATTACHMENT 1 – PRICE SCHEDULE - PART A - COMPONENTS CATALOG for each facility covered under the contract. The components are listed as Brand Name or equal for most items. All CPT and CPT component substitutions require prior approval by the Contracting Officer throughout the life of the contract.

1) The Contractor shall provide all components required for each CPT.

2) All packs shall be made of hard plastic base trays and components parts to reduce ETO (Ethylene Oxide) residue and eliminate possible particulate contamination from Styrofoam. ETO tape/indicator shall be affixed to the outer wrap and tray where applicable. All packs shall be double wrapped with an additional plastic over wrap (gas pouch). The over wrap shall be considered a dust cover only.

3) Substitution Process

(a) Any item requiring substitution will first be presented by the Contractor to the Contracting Officer Representative (COR) from the appropriate VA facility.

(b) A sample of the proposed substitution and complete specifications will be provided to the facility by the contractor for VA review. The COR will coordinate and gather input from applicable end users to validate the item as a suitable substitute.

(c) If the substitute component(s) is found acceptable by VA, the COR will submit a contract modification request to the Contracting Officer for further determination and approval.

(d) If the substitute component(s) is declined by the VA, the COR will submit a contract modification request to the Contracting Officer for removal of the item when there is no suitable substitution.

(e) Substitutions and item removal are only permitted with contract modification.

4) 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 requirements of the National Fire Protection Regulations for flammability in Part 1610 of the Code of Federal Regulations.

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

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

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

(d) Gowns shall fit and allow freedom of movement. Gowns shall have stockinet cuffs, raglan sleeves and welded or stitched seams.

(e) Gowns and drapes shall maintain an environment appropriate to body temperatures.

(f) 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. They must meet Level 4 requirements of the AAMI PB70:2012 Liquid Barrier Classifications.

5) When specified within a CPT, cloth towels shall be absorbent made of 100% cotton, pre-washed, and x-ray detectable.

6) All CPTs shall be free of debris and excessive particulates.

7) All CPT components and wrappings shall be Latex Free unless specified otherwise by the using facility. All latex-free CPTs shall be labeled as “Totally Latex Free” on the outside covering.

8) Unavailability of Component Parts: Should a component part become unavailable which will temporarily or permanently delay the production of the pack(s), the Contractor shall immediately notify the Contracting Officer’s Representative (COR) and Contracting Officer with written notice to follow within five (5) calendar days of the situation and the anticipated length of delay. No deletions or substitutions will be made without written authorization from the Contracting Officer. If it is necessary and authorization is obtained to substitute a component, the substitution must be of the same or greater quality and will be at no additional cost to the Government. 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. The cost of the pack must be adjusted to reflect the change.

9) Recalls: The Contractor shall have a documentation system for component product accountability and lot number recordings for product recalls. The Contracting Officer shall be notified in writing if any components are affected by a product recall. If the recalled component is unavailable for further production of the custom pack(s), no substitutions will be made by the Contractor without written authorization of the Contracting Officer.

D. CHANGES TO COMPOSITION/COMPONENTS OF CPT(S)

VA may request a change to individual component parts of the tray/pack after thirty (30) days of usage. Pricing and requested changes will be forwarded to the Contractor by the VA facility

COR. The Contractor shall consider all component part changes and provide a price estimate of each item to be changed. The price proposal from the contractor will include information about increased or decreased rates for the CPT(s) based off of the replacement component(s) as well as any components that are going to be removed or added to the CPT(s). In accordance with FAR clause 52.212-4(c), 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.

1) A Pack Change Worksheet shall be utilized for all pack changes. The change form includes all of the components, quantity and manufacturer detail for the affected pack. The sales representative (or equivalent) shall supply the VA COR with the completed change form. With the agreement of the two parties, each shall sign the change form.

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

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.

3) The Contractor shall provide each facility with an electronic inventory report monthly 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 Contractor and the COR with a mutual determination to adjust inventory levels.

4) The arrangement of the component parts in the tray/pack shall be coordinated by both the Contractor and COR. This coordination shall be prior to production by the Contractor.

E. PACKAGING

Unless otherwise specified in the specification, 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 for each facility. Items shall be packaged adequately to prevent deterioration and damage during shipping, handling and storage. All latex-free packs shall be labeled on the outside as Totally Latex Free.

1) Each pack shall have a label specifying the manufactured date of the pack and the expiration date (as needed) of any components. This label, located inside of each pack, shall also contain an itemized listing of all components, including quantities.

2) All outer packaging must contain the complete contract number and delivery order number in addition to the shipping address. The contract number shall be provided upon notice of contract award.

3) A packing list/slip shall be enclosed with each shipment indicating the contract number, delivery order number, items and quantity ordered and items and quantity shipped.

4) 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.

3. PRODUCTION AND SUPPLY

The Contractor shall implement component pack changes within thirty (30) days after written notification by the Contracting Officer. The Government shall be obligated to only a thirty (30) day supply of packs manufactured at the time of the change acceptance.

4. QUALITY ASSURANCE

A. The CPT sterilization assembly facilities shall be registered and in good standing with The Food and Drug Administration (FDA) and submit annually a copy of the current FDA accreditation certificate to the COR and/or CO at least 60 calendar days before the contract expires.

B. The contractor shall ensure that all individual components within the pack are Trade Agreement Act (TAA) compliant unless otherwise authorized by the CO to place orders from a non-TAA compliant country. The TAA requires that end products from designated countries be treated the same as U.S.-made products for government procurement purposes, and prohibits the acquisition of end products from other, non-designated countries. As such, the TAA provides an exception to the Buy America Act (BAA), which is intended to promote the acquisition of “domestic [US] end products.”

See FAR 25.100-102; see also FAR Clauses 52.225-1; 52.225-2. The TAA applies a rule-of- origin requirement to the end product being supplied and requires that end products acquired by the Government must be “wholly the growth, product or manufacture” of the U.S. or of a designated country, or “substantially transformed [in the U.S. or a designated country] into a new and different article of commerce with a name, character, or use distinct from that of the article or articles from which it was transformed.” See FAR 25.003.

C. A “Quality System Program” to prevent non-conformance at all product/service stages from design through distribution must be utilized. It is designed to comply with the requirements 21 CFR 820 (Code of Federal Regulations), EN 46001 (European Nations Quality Standards), and United States regulations regarding the sales and distribution of medical products.

5. CONTRACTOR PERSONNEL

A. Contractor’s Program Manager. The Contractor shall provide a Program Manager who shall be responsible for the performance of work. The name and contact information of this person shall be designated in writing to the Contracting Officer, along with a backup point of contact. The Contractor’s program manager shall have full authority to act for the Contractor on all matters relating to daily operations of this contract.

6. INSPECTIONS

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) calendar days when notified by the COR.

7. HOURS OF OPERATION

A. Delivery days are Monday through Friday, National Holidays excluded. Any delivery service performed during other than normal work hours must be approved in advance by the COR. Each facility will specify its delivery hours and complete address.

B. Holidays. The Contractor is not required to provide delivery services on the following National Holidays nor shall the Contractor be paid for these holidays:

Holiday Date(s) Month New Year's Day 1 January Martin Luther King's Birthday Third Monday January President's Day Third Monday February Memorial Day Last Monday May Independence Day 4 July Labor Day First Monday September Columbus Day Second Monday October

Veterans Day 11 November Thanksgiving Day Fourth Thursday November Christmas Day 25 December

When a holiday falls on a Sunday, the following Monday shall be observed as a National Holiday. When a holiday falls on a Saturday, the proceeding Friday is observed as a National Holiday by U.S. Government agencies. Also included, would be any other day, specifically declared by the President of the United States of America to be a National Holiday.

8. ORDERING, INVOICE AND PAYMENT

A. Delivery Orders shall be issued by electronic commerce and only by the Contracting Officer or designated Purchasing Agents for the CPTs outlined in the schedule of items identified in the awarded contract.

Delivery Orders shall contain at a minimum the following information:

a. Date of order;

b. Contract Number and Order Number;

c. CPT Tray Number, Description, Quantity, Unit Price, and Total Amount;

d. Delivery or performance Schedule; and

e. Place of Delivery or Performance

f. Any packaging, packing, and shipping instructions.

g. Accounting and appropriation data.

B. The Contractor shall submit properly completed individual itemized invoices to the addresses designated by the facilities to receive invoices, in accordance with VAAR clause 852.232-72 Electronic Submission of Payment Requests. In addition to the requirements of VAAR 852.232-72, the invoice shall also include the facility’s name and address where the product is delivered and the delivery order number. The invoice address payment office shall be provided to the Contractor at time of delivery order placement by the order-placing facility. Additional information can be found in the contract administration section of the contract.

C. No advance payments shall be authorized. Payment shall be made on a monthly basis for product provided during the billing month in arrears in accordance with VAAR 852.232-72 upon submission of a properly prepared invoice for prices stipulated in this contract for products delivered and accepted in accordance with the terms and conditions of the contract, less any deductions stipulated in this contract.

D. Payment of invoices may be delayed if the appropriate invoices as specified in the contract are not completed and submitted as required.

9. DELIVERY REQUIREMENTS

All deliveries for this contract shall be FOB Destination only in accordance with FAR Clause 52.247-34. Deliveries shall be made within forty-eight (48) hours or as needed from receipt of order by the contractor from the ordering facility.

10. FURNISHED ITEMS AND SERVICES

A. The Government shall not provide the facilities, equipment, materials, or any products under this contract.

B. The Contractor shall furnish and provide everything required to perform this contract in accordance with all of its terms.

SECTION C - CONTRACT CLAUSES

FAR

Number

Title Date

52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

ITEMS

OCT 2018

ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

ITEMS

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 52.216-18 ORDERING (AUG 2020)

(a) Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders or task orders by the individuals or activities designated in the Schedule. Such orders may be issued from contract award date through contract completion date.

(b) All delivery orders or task orders are subject to the terms and conditions of this contract. In the event of conflict between a delivery order or task order and this contract, the contract shall control.

(c) A delivery order or task order is considered "issued" when—

(1) If sent by mail (includes transmittal by U.S. mail or private delivery service), the Government deposits the order in the mail;

(2) If sent by fax, the Government transmits the order to the Contractor’s fax number; or

(3) If sent electronically, the Government either—

(i) Posts a copy of the delivery order or task order to a Government document access system, and notice is sent to the Contractor; or

(ii) Distributes the delivery order or task order via email to the Contractor’s email address.

(d) Orders may be issued by methods other than those enumerated in this clause only if authorized in the contract.

(End of Clause)

C.2 52.216-19 ORDER LIMITATIONS (OCT 1995)

(a) Minimum order. When the Government requires supplies or services covered by this contract in an amount of less than $100.00, the Government is not obligated to purchase, nor is the Contractor obligated to furnish, those supplies or services under the contract.

(b) Maximum order. The Contractor is not obligated to honor—

(1) Any order for a single item in excess of the Maximum Ceiling Value;

(2) Any order for a combination of items in excess of the Maximum Ceiling Value; or

(3) A series of orders from the same ordering office within 1 days that together call for quantities exceeding the limitation in paragraph (b)(1) or (2) of this section.

(c) If this is a requirements contract (i.e., includes the Requirements clause at subsection 52.216-21 of the Federal Acquisition Regulation (FAR)), the Government is not required to order a part of any one requirement from the Contractor if that requirement exceeds the maximum-order limitations in paragraph (b) of this section.

(d) Notwithstanding paragraphs (b) and (c) of this section, the Contractor shall honor any order exceeding the maximum order limitations in paragraph (b), unless that order (or orders) is returned to the ordering office within 1 days after issuance, with written notice stating the Contractor's intent not to ship the item (or items) called for and the reasons. Upon receiving this notice, the Government may acquire the supplies or services from another source.

(End of Clause)

C.3 52.216-22 INDEFINITE QUANTITY (OCT 1995)

(a) This is an indefinite-quantity contract for the supplies or services specified, and effective for the period stated, in the Schedule. The quantities of supplies and services specified in the Schedule are estimates only and are not purchased by this contract.

(b) Delivery or performance shall be made only as authorized by orders issued in accordance with the Ordering clause. The Contractor shall furnish to the Government, when and if ordered, the supplies or services specified in the Schedule up to and including the quantity designated in the Schedule as the "maximum." The Government shall order at least the quantity of supplies or services designated in the Schedule as the "minimum."

(c) Except for any limitations on quantities in the Order Limitations clause or in the Schedule, there is no limit on the number of orders that may be issued. The Government may issue orders requiring delivery to multiple destinations or performance at multiple locations.

(d) Any order issued during the effective period of this contract and not completed within that period shall be completed by the Contractor within the time specified in the order. The contract shall govern the Contractor's and Government's rights and obligations with respect to that order to the same extent as if the order were completed during the contract's effective period;

provided, that the Contractor shall not be required to make any deliveries under this contract after the completion date of outstanding orders.

(End of Clause)

C.4 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 30 calendar days.

The specified rates under this clause will be those rates in effect under the contract each time an option is exercised under this clause.

(End of Clause)

C.5 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR

2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within 30 calendar days; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 60 calendar days before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed five (5) years.

(End of Clause)

C.6 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA

ACQUISITION OF COMMERCIAL ITEMS (APR 2020)

(a) The Contractor agrees to comply with any provision or clause that is incorporated herein by reference to implement agency policy applicable to acquisition of commercial items or components. The following provisions and clauses that have been checked by the Contracting Officer are incorporated by reference.

[X] 852.203–70, Commercial Advertising.

[] 852.209–70, Organizational Conflicts of Interest.

[] 852.211–70, Equipment Operation and Maintenance Manuals.

[] 852.214–71, Restrictions on Alternate Item(s).

[] 852.214–72, Alternate Item(s). [Note: this is a fillable clause.]

[] 852.214–73, Alternate Packaging and Packing.

[] 852.214–74, Marking of Bid Samples.

[] 852.215–70, Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors.

[] 852.215–71, Evaluation Factor Commitments.

[] 852.216–71, Economic Price Adjustment of Contract Price(s) Based on a Price Index.

[] 852.216–72, Proportional Economic Price Adjustment of Contract Price(s) Based on a Price Index.

[] 852.216–73, Economic Price Adjustment—State Nursing Home Care for Veterans.

[] 852.216–74, Economic Price Adjustment—Medicaid Labor Rates.

[] 852.216–75, Economic Price Adjustment—Fuel Surcharge.

[] 852.219–9, VA Small Business Subcontracting Plan Minimum Requirements.

[X] 852.219–10, VA Notice of Total Service-Disabled Veteran-Owned Small Business Set- Aside.

[] 852.219–11, VA Notice of Total Veteran-Owned Small Business Set-Aside.

[] 852.222–70, Contract Work Hours and Safety Standards—Nursing Home Care for Veterans.

[] 852.228–70, Bond Premium Adjustment.

[] 852.228–71, Indemnification and Insurance.

[] 852.228–72, Assisting Service-Disabled Veteran-Owned and Veteran-Owned Small Businesses in Obtaining Bonds.

[X] 852.232–72, Electronic Submission of Payment Requests.

[X] 852.233–70, Protest Content/Alternative Dispute Resolution.

[X] 852.233–71, Alternate Protest Procedure.

[] 852.237–70, Indemnification and Medical Liability Insurance.

[X] 852.246–71, Rejected Goods.

[] 852.246–72, Frozen Processed Foods.

[X] 852.246–73, Noncompliance with Packaging, Packing, and/or Marking Requirements.

[X] 852.270–1, Representatives of Contracting Officers.

[] 852.271–72, Time Spent by Counselee in Counseling Process.

[] 852.271–73, Use and Publication of Counseling Results.

[] 852.271–74, Inspection.

[] 852.271–75, Extension of Contract Period.

[] 852.273–70, Late Offers.

[] 852.273–71, Alternative Negotiation Techniques.

[] 852.273–72, Alternative Evaluation.

[] 852.273–73, Evaluation—Health-Care Resources.

[X] 852.273–74, Award without Exchanges.

(b) All requests for quotations, solicitations, and contracts for commercial item services to be provided to beneficiaries must include the following clause:

[] 852.237–74, Nondiscrimination in Service Delivery.

(End of Clause)

C.7 VAAR 852.219-74 LIMITATIONS ON SUBCONTRACTING—

MONITORING AND COMPLIANCE (JUL 2018)

(a) This solicitation includes VAAR 852.219-10 VA Notice of Total Service- Disabled Veteran- Owned Small Business Set-Aside.

(b) Accordingly, any contract resulting from this solicitation is subject to the limitation on subcontracting requirements in 13 CFR 125.6, or the limitations on subcontracting requirements in the FAR clause, as applicable. The Contractor is advised that in performing contract administration functions, the Contracting Officer may use the services of a support contractor(s) retained by VA to assist in assessing the Contractor's compliance with the limitations on subcontracting or percentage of work performance requirements specified in the clause. To that end, the support contractor(s) may require access to Contractor's offices where the Contractor's business records or other proprietary data are retained and to review such business records regarding the Contractor's compliance with this requirement.

(c) All support contractors conducting this review on behalf of VA will be required to sign an “Information Protection and Non-Disclosure and Disclosure of Conflicts of Interest Agreement” to ensure the Contractor's business records or other proprietary data reviewed or obtained in the course of assisting the Contracting Officer in assessing the Contractor for compliance are protected to ensure information or data is not improperly disclosed or other impropriety occurs.

(d) Furthermore, if VA determines any services the support contractor(s) will perform in assessing compliance are advisory and assistance services as defined in FAR 2.101,…