S02 36C77621R0021.docx

36C77621R0021: MIDCON BRAND NAME CUSTOM STERILE PROCEDURE PACKS

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

36C77621R0021 02-16-2021 Ann Schilli 612-330-3619 03-01-2021

13:00PM CST

CST

36C776 Department of Veterans Affairs Program Contracting Activity Central

212 3rd Ave. South, Suite 29 Minneapolis MN 55401

X

339113 750 Employees

N/A

36C776 Department of Veterans Affairs Program Contracting Activity Central

212 3rd Ave. South, Suite 29 Minneapolis MN 55401 00776 Department of Veterans Affairs Program Contracting Activity Central

212 3rd Ave. South, Suite 29 Minneapolis MN 55401

VAFSC

Department of Veterans Affairs Financial Services Center Invoices to be submitted electronically www.ob10.com/us/en/veterans-affairs/ E-Invoice setup info phone 877-489-6135 877-353-9791 512-460-5429

See CONTINUATION Page

Contractor shall provide all labor, materials and equipment for Avid Medical Inc. Brand Name Custom Sterile Procedure Packs for VISNs (9, 10, 15, 16, and 23)

This requirement is being procured in accordance with

FAR 12 Acquisition of Commercial Items and FAR 15 Contracting by Negotiation

Please refer to Section E.2 Instructions to Offerors for how to submit a proper proposal.

See CONTINUATION Page

(1)

Nicole Kutsi

VA-VHA-2020-E324CCD1

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 36C776 Department of Veterans Affairs Program Contracting Activity Central 212 3rd Ave. South, Suite 29 Minneapolis MN 55401

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

3. PAYMENTS AND INVOICING: Invoices shall be submitted in arrears:

VA shall review the invoice against its record. VA shall notify the Contractor of invoice discrepancies. Upon the resolution of the discrepancies, VA shall approve the invoice and make payment to the Contractor. It shall be considered fraudulent for the Contractor to bill for products that are insufficient to fulfill the requirements for items covered by the Trade Agreements Act. Invoice shall be paid within thirty (30) days upon final acceptance by the Government. Each invoice must comply with the requirements of FAR 52.212-4 Contract Terms and Conditions – Commercial, to include required information as follows:

(1) Facility’s name and address where supply was provided.

(2) Contract number. (example – 36C77621DXXXX)

(3) Purchase order number. (example – 240- R1XXXX)

(4) Type of supply provided When submitting electronic invoices, the contractor shall submit an original copy of the contractor’s invoice for backup documentation. For instructions to submit the original copy of invoice go to:

https://www.tungsten-network.com/veteransaffairs Tungsten has tutorials on their website under FAQ page to assist with instruction on uploading invoices. Customer Support help desk number 1-877-489- 6135.

No advance payments shall be authorized. Invoices will be shared with the COR prior to submission to the VA Finance Center for review and coordination.

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

4. NOTICE OF INDIVIDUALS AUTHORIZED TO PURCHASE UNDER IDIQ: Ordering officers (OOs) will be authorized to place orders against this contract. The Contracting Officer (CO) will furnish the Contractor with the names of individuals authorized as OOs, by separate memorandum upon issuance of the contract. When OOs are added after award, the CO will furnish the Contractor with the names of individuals authorized as OOs, by memorandum upon OO appointment. OOs are responsible for issuing and administering orders placed under this contract. OOs have no authority to modify any term of this basic contract. Any deviation from the terms of the basic contract must be approved in writing by the CO responsible for this contract. The Contractor shall accept orders against this contract only from the CO and/or authorized OOs. Fulfilling orders from persons other than the CO or OO may result in loss or delay in payment for supplies/services provided under such orders.

5. 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 Services Center Invoices to be submitted electronically www.ob10.com/us/en/veterans-affairs/ E-Invoice setup info phone 877-489-6135 ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

B.2 STATEMENT OF WORK

MIDCON CENTRAL REGION CUSTOM STERILE PROCEDURE PACKS

1. ABBREVIATIONS

AAMI:

Association for Advancement of Medical Instrumentation

2. GENERAL:

2.1. The Veterans Health Administration (VHA), Midwest Consortium (MIDCON) has established a requirement for the ongoing supply of brand name custom sterile procedure packs and associated services supplied for an estimated 26 VA Medical Centers throughout the Central Region (VISNs 9,10, 15, 16 and 23). The contractor shall provide Avid Medical Inc brand name custom sterile procedure packs as outlined in Attachment (2) Schedule of Items. All brand name custom sterile procedure pack assembly, packaging and sterilization must adhere to the quality control standards established by the Food and Drug Administration (FDA).

2.2. All Avid Medical Inc brand name custom sterile procedure packs shall be delivered to the Veterans Administration Medical Centers/Health Care System Networks provided in Attachment (1) Delivery Locations. All Avid Medical Inc brand name custom sterile procedure packs requested by a participating facility are required to be available for delivery by no later than April 1, 2021.

2.3. The Contractor will be required to provide all labor, materials, transportation, equipment and supervision, in compliance with federal, state and local regulations. The quantities shown in Attachment (2) Schedule of Items are estimates of each facility’s annual requirement.

2.4. A Contracting Officer Representative (COR) will be designated for each ordering facility. The COR is responsible for local contract administration issues such as requesting deliveries and providing specific delivery instructions. The Contractor will be provided the names and contact information of the primary and alternate COR within ten (10) days after award of the contract for each ordering facility.

3. ORDERING:

3.1 Ordering Officers (OOs) will be authorized to place orders against this contract. The Contracting Officer (CO) will furnish the Contractor with the names of individuals authorized as OO’s by separate memorandum upon issuance of the contract. When OO’s are added after award, the CO will furnish the Contractor with the names of individuals authorized as OOs, by memorandum upon OO appointment. OOs are responsible for issuing and administering orders placed under this contract. OOs have no authority to modify any term of this basic contract. Any deviation from the terms of the basic contract must be approved in writing by the CO responsible for this contract. The Contractor shall accept orders against this contract only from the CO and/or authorized OOs. Fulfilling orders from persons other than the CO or OO may result in loss or delay in payment for supplies/services provided under such orders.

3.2 All delivery orders (DOs) are subject to the terms and conditions of this contract. Orders shall be placed against this contract via electronic commerce using the Line Item Number series outlined in the Schedule of Items identified in the awarded contract. Delivery orders shall contain at a minimum the following information:

3.2.1 Date of order

3.2.2 Contract Number and IFCAP Purchase Order Number

3.2.3 Line Item Number

3.2.4 Custom Sterile Procedure Pack Description

3.2.5 Quantity

3.2.6 Unit Price

3.2.7 Total Amount

3.2.8 Place of Delivery or Performance

3.2.9 Obligated Delivery Order

3.3 The Contractor shall accept orders until 12:00 PM Central Standard Time (CST) to exclude weekends and holidays. Upon receipt of the order(s), the contractor shall send a confirmation (via electronic commerce methods) of the request within 24 hours of the notification of order.

3.4 Upon receiving an order, the Contractor shall deliver within three (3) calendar days for standard deliveries and within twenty-four (24) hours for emergency deliveries, unless otherwise stated in the delivery order.

3.5 The Contractor shall have full-time representation to receive orders and/or to address delivery/customer service issues. The contractor shall respond with an acknowledgement of orders and/or delivery/customer service issues within 48 hours.

3.6 The Government shall place delivery orders to the following: (Offeror to complete)

3.7 The Government shall contact the following for any delivery/customer service issues: (Offeror to complete)

3.7.1 Customer Service Number:_______________________

3.7.2 Customer Service Email:_________________________

3.8 The contractor shall also provide additional flexible ordering options such as scheduled and funded automatic shipments. Under this contract some facilities with reoccurring known needs may require flexibilities to place daily, weekly, monthly, quarterly, annual, or other interval orders upon facility conversion to be delivered at specified dates. Once placed, the ordering frequency may need to change at any time for orders to be delivered within the contractually required timeframes. The Government requires a supplier that can be flexible in meeting the changing needs of the Government. The scenarios are not all-inclusive of the Government’s needs but are representative of the flexibilities necessary.

4 DELIVERY REQUIREMENTS

A. All deliveries are FOB Destination to the participating facilities specified in Attachment (1) Delivery Locations. Supplies shall be delivered to the destination warehouse unloading platform, or receiving dock, at the expense of the Contractor, with the exception of emergency orders. The Government shall not be liable for any delivery, storage, demurrage, accessorial, or other charges involved before the actual delivery (or “constructive placement” as defined in carrier tariffs) of the supplies to the destination. If motor carrier (including “piggyback”) is used, supplies shall be delivered to truck tailgate at the unloading platform of the consignee, except when the supplies delivered meet the requirements of Item 568 of the National Motor Freight Classification for “heavy or bulky freight.” When supplies meeting the requirements of the referenced Item 568 are delivered, unloading (including movement to the tailgate) shall be performed by the consignee, with assistance from the truck driver, if requested. If the contractor uses freight forwarded for less than carload shipments, the contractor shall ensure that the carrier will furnish tailgate delivery, when required, if transfer to truck is required to complete delivery to consignee.

B. Upon receipt of an individual delivery order issued by participating facilities, for approved manufactured and ready for distribution packs, deliveries of such packs shall be made within 72 hours. Each delivery order will state the quantity of packs required, delivery date, and delivery and billing address. A delivery order number will be assigned to each request for delivery against this contract.

C. Emergency deliveries, if required, must be delivered within 24 hours. Emergency deliveries may be subject to additional shipping costs, unless the emergency is due to a vendor backorder. Additional shipping cost shall be a fixed price provided in the schedule.

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

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

Fill Rate = Lines Packs Filled + 1/2 Packs Partially Filled Total Packs ordered – Contractual Exceptions

5 PACKAGING

5.1 Unless otherwise specified in the Statement of Work (SOW), the product shall be packed in substantial containers of the type, size and kind commonly used within the industry for this purpose. The container(s) will be constructed as to ensure acceptance and safe delivery by common carriers to the point of delivery designated by each facility. Items must be packaged adequately to prevent deterioration and damage during shipping, handling and storage. All packs containing latex products must be clearly labeled on the outside covering. All products containing latex must also be individually labeled and clearly state that containing latex.

5.1.1 Each pack shall have a label specifying the manufactured date and sterilization date of the pack and the expiration date of any dated products. This label, located inside of each pack, shall also contain an itemized listing of all components, as well as any missing items that were approved to be left out by the VA. Pack contents list must contain item, quantity, and country of origin information. Color coded packs, or some sort of visual cue to distinguish between pack types must be available upon request by the COR at no additional charge. Expiration dating of all custom sterile procedure packs delivered under this contract shall have a minimal shelf life of six (6) months remaining upon delivery to the Government. Prior written approval by the facility COR is required before delivery of short dated products.

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

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

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

6 MANUFACTURING

6.1 ASSEMBLY AND STERILIZATION

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

6.1.1 The Contractor shall validate the sterilization process, with the Association for Advancement of Medical Instrumentation (AAMI) annually at a minimum.

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

6.1.3 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. International Association of Healthcare Central Service Material Management (IAHCSMM) (https://www.iahcsmm.org) and Association for the Advancement of Medical Instrumentation (AAMI) (http://www.aami.org) provide guidelines for proper attire.

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

6.1.5 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.

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

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

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

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

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

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

6.1.12 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.

6.2 COMPONENT PARTS

6.2.1 Current Avid Medical Inc brand name custom sterile procedure pack components shall remain the same unless the Government is notified by the Contractor of any component recall or a component becomes obsolete. SEE 6.3 UNAVAILABILITY OF COMPONENT PARTS for further instruction.

6.2.2 Government may require minor modification of components to brand name custom sterile procedure packs. These changes are allowable at the start of every Government quarter (October, January, April, and July) and will only be allowed and approved through contract modification. Government will be responsible for purchasing existing stock of already manufactured packs and not to exceed sixty (60) days of inventory.

6.2.3 For items that are subject to minor modification, these shall be clearly identified with country of origin, and shall be TAA compliant.

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

6.2.5 All packs are to use hard plastic base trays and components parts to reduce Ethylene Oxide (ETO) residue and eliminate possible particulate contamination from Styrofoam. Biodegradable trays that have the same affect are acceptable. All custom packs shall be sterilized in an approved packaging material with a plastic dust cover. Custom packs material must allow the sterilization of the contents, maintain sterility, and provide a way to remove the contents without contamination. Plastic dust covers 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 should be chosen to allow penetration of the sterilization process, avoid constriction of the package and maintain package integrity.

6.2.6 Requirements for gowns and drapes shall meet the following criteria:

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

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

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

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

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

6.2.6.6 When substitutions are necessary and approved for surgical gowns and drapes, quantitative data must be available to show that the materials for surgical gowns and drapes provide an effective barrier to microbes. The materials must 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 must 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.

6.2.7 The materials for cloth towels must 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 must 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. When substitutions are necessary and approved for cloth towels, x-ray detectable or not, they are to be absorbent, disposable or towels made of 100% cotton, and pre-washed.

6.2.8 All components must be Latex Free unless specified otherwise by the using 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.

6.3 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 (COR) and the Contracting Officer (CO) by telephone (with written notice to follow within five (5) calendar days) of the situation and the anticipated length of delay.

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

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

1. Contract and Delivery Order

1. Reason for unavailability

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

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

The contractor shall notify the COR and the CO 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 provide assistance to the Contractor and the participating customers during the MBO period.

No deletions or substitutions will be made without a written authorization and contract modification from the CO. 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 CO or COR. The cost of the pack must be adjusted to reflect the change. In addition, the content listing will clearly identify any missing items approved to be left out by the VA.

7 CONTRACTOR CUSTOMER REPRESENTATIVES

The Contractor shall provide one Customer Representatives per VISN who shall act as the primary liaison between the VISN and the contractor regarding usage of pack volumes to manage production/inventory levels, backorder issues, minor modifications of pack components, and site visits. These Customer Representatives shall be available regardless of ordering or distribution method. No later than ten (10) days after contract award date, the VA shall be provided with a list of Representatives serving each site covered under this contract. The contact list shall include name, phone, email, assignment location and any other contact info, etc.

7.1 The name of this person shall be designated in writing to the CO. The Contractor’s program manager shall have full authority to act for the Contractor on all matters relating to daily operations of this contract.

7.2 The customer representative shall work with each station to determine an accurate estimated monthly usage not to exceed sixty (60) day inventories. The Government will be responsible for purchasing any unutilized custom sterile procedure packs not to exceed sixty (60) days of inventory.

8 CONTRACTOR ELECTRONIC COMMUNICATION AND REPORTING REQUIREMENTS

0. At a minimum the contractor shall utilize a web-based system that provides for electronic communication for inventory tracking to include: digital imagery, management program, and reporting services for the purposes of projecting needs. The web-based system will allow for electronic signature for pack conversions. Minor pack modifications will require CO written approval and contract modification. Minor pack modifications will also require signatures from both clinical and COR. It will provide non-editable access to the database for all personnel authorized by the COR for the purpose of identifying like packs across the region. It will provide for easy identification of component, product utilization, latex, sterilization requirements, country of origin information, and VA standardization information. This electronic communication and inventory tracking system shall be available regardless of the ordering or distribution method.

0. Custom Sterile Procedure Pack Status Reports shall be provided to the VA by the contractor monthly. Reports submitted shall be marked as “Contractor Reports”. Reports need to be submitted to the CO/CS by the 15th of every month. The reports shall be tailored to each VISN with the ability to compare against other facilities within the Central region. Reports shall include but not be limited to the following:

1. Fill rates to include calculation details and explanation of exclusions, if any;

1. Quality Delivery Reports to include returns and exchange information, emergency deliveries, and drop shipments;

1. Usage by pack includes estimated monthly usage (EMU), inventory on hand (defined how many days/months on hand), inventory in production, inventory in planning, and quantity in transit;

1. Substitution information including name of person authorizing the substitution;

1. Credit and rebill information and outstanding invoice information, to include specifics that would allow the COR to follow up;

1. Contractor Supply Problem Report that includes identification of any problems encountered with MBO situations, shipping or delivery problems and recalls.

1. Monthly Sales Report– in order for the contracting office to submit the required financial reporting on FPDS-NG, the contractor shall submit CENTRAL REGION CUSTOM PACKS MONTHLY REPORTING TOOL on a monthly basis to the Contract Specialist. The report is due by the 15th of each month. Reports shall include VISN, station, tray number, case price, unit of measure (UOM), and total sales amounts. Reports shall be sent electronically to the Government designated point of contact (POC) until the contractor is notified, in writing, of a different POC.

0. Contractor shall provide proof of Workers Compensation and Employee Public Liability Insurance within fifteen (15) calendar days after notification of contract award.

9 QUALITY ASSURANCE

9.1 The Custom Sterile Procedure Pack manufacturing facilities must be registered and in good standing with FDA and ISO9001:2000 certified ISO, CEN (European Committee for Standardization), AAMI (Association of the Advancement of Medical Instrumentation), and AORN (Association of Operating Room Nurses) are other industry standards that must be met. Per FAR 25.4 Trade Agreements, each end product is certified as a U.S.-made, designated country, Caribbean Basin country, or NAFTA country (Canada or Mexico) end product.

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

9.3 Brand Name Custom Sterile Procedure Packs must provide certain measures in the manufacturing of the packs.

9.3.1 Product specifications including video images, bills of material, biological evaluations, component specification, and identification of critical design and process parameters. These include how the parameter is to be met;

9.3.2 Production process specifications, including the appropriate equipment specification, production methods, production procedures, compatibility of the design with current systems and equipment;

9.3.3 Quality assurance procedures and specifications, i.e. quality plan, including quality assurance checks used, and the quality testing apparatus, fixtures, resources, skills, subjective standards and documentation used;

9.3.4 Packaging and labeling specifications, including methods and processes used;

9.3.5 Sterilization requirements and methods;

9.3.6 Testing requirements and methods.

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

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

B.3 SCHEDULE OF ITEMS

SEE ATTACHMENT (1) SCHEDULE OF ITEMS

Scope of Contract:

The Department of Veterans Affairs (VA), Midwest Consortium (MIDCON) has established a requirement for the ongoing supply of brand name custom sterile procedure packs and associated services supplied for an estimated 26 VA Medical centers throughout the Central Region Veteran Integrated Service Networks (VISNs) 9, 10, 12, 15, 16 and 23. Custom sterile procedure packs and associated services supplied shall be in accordance with the schedule, specifications described in the Statement of Work (SOW), and the terms and conditions of this solicitation for the period of April 1, 2021 through March 31, 2023 unless terminated earlier pursuant to the terms of the contract (Please see Attachment (2) Schedule of Items.

Schedule of Items:

The Schedule is provided in an Excel spreadsheet format. Each Line Item consists of the VISN and the facility. The Subline items consists of the Brand Name Custom Sterile Procedure Packs tray number and description. The Offeror shall complete the pricing schedule attachment for ALL VISNs/Facilities and ALL PACKS to be considered for award.

36C77621R0021: MIDCON BRAND NAME CUSTOM STERILE PROCEDURE PACKS

See attached document: SCHEDULE.

Page 1 of Page 1 of

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (OCT 2018)

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

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

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

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

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

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

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

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

(g) Invoice.

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

(i) Name and address of the Contractor;

(ii) Invoice date and number;

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

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

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

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

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

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

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

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

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

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

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

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

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

(i) Payment.—

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

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

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

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

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

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

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

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

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

(D) Contractor point of contact.

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

(6) Interest.

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

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

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

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

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

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

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

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

(A) The date fixed under this contract.

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

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

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

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

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

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

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

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

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

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

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

(m) Termination for cause. The Government may terminate this contract, or any part hereof, for cause in the event of any default by the Contractor, or if the Contractor fails to comply with any contract terms and conditions, or fails to provide the Government, upon request, with adequate…