36C77625R0017_1.docx

36C77625R0017 – Custom Sterile Procedure Packs

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1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

UEI:

EFT:

PHONE:

FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA

26. TOTAL AWARD AMOUNT (For Govt. Use Only) 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. NOV 2021)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

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

36C77625R0017 01-13-2025 Laura Nabity, Contract Specialist 612-629-7198 02-24-2025 1:00 p.m.

CST

36C776 Department of Veterans Affairs Program Contracting Activity Central Attn: PCAC Supply 1 6100 Oak Tree Blvd, Suite 490 Independence OH 44131 X 339113 800 Employees N/A X 36C776 Department of Veterans Affairs Program Contract Activity Central VISNs 5, 9, 10, 12, 15, 16, and 23 VA Medical Centers, see Attachment D.1 - Delivery Locations 36C776 Department of Veterans Affairs Program Contracting Activity Central PCAC Supply 1 6100 Oak Tree Blvd, Suite 490 Independence OH 44131

VAFSC

Department of Veterans Affairs Financial Services Center Invoices to be Submitted Electronically https://www.fsc.va.gov/einvoice.asp e-Invoice Setup Info Phone 877-489-6135 877-353-9791 512-460-5429 Contractor shall provide Custom Sterile Procedure Packs and associated services for VA Medical Centers located in VISNs 5, 9, 10, 12, 15, 16, and 23; see Attachment D.1 - Delivery Locations.

This requirement is being procured in accordance with FAR Part 12, Acquisition of Commercial Products and Commercial Services, and FAR Part 15, Contracting by Negotiation.

Refer to Sections E.1 and E.2 - Instructions to Offerors on how to submit a Proposal.

Contract will use Authorized Ordering Officers X X X -one- Paris Everson

VA-VHA-2020-F566D7A6

Table of Contents

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS 59

ATTACHMENT D.1 - DELIVERY LOCATONS

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: Name:

Address:

b. GOVERNMENT: Contracting Office 36C776 Department of Veterans Affairs Program Contracting Activity Central (PCAC) Attn: PCAC Supply 1 6100 Oak Tree Blvd, Suite 490 Independence OH 44131

Contracting Officer: Paris Everson, Paris.Everson@va.gov Contract Specialist: Sharif Ra-el, Sharif.Ra-el@va.gov Contract Specialist: Laura Nabity, Laura.Nabity@va.gov Contract Specialist: Shaun Pitts, Shaun.Pitts@va.gov Contract Specialist: Shannon Croft, Shannon.Croft@va.gov

**If Government Point of Contacts (POCs - Contracting Officer, Contract Specialist) Change, notification will be sent via email. A contract modification shall not be required.

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

3. INVOICES: Invoices shall be submitted electronically in arrears:

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

Department of Veterans Affairs Financial Services Center (FSC)

PO BOX 149971

Austin, TX 78714-9971 https://www.fsc.va.gov/einvoice.asp

Electronic form means an automated system transmitting information electronically according to the accepted electronic data transmission methods below.

a. VA’s Electronic Invoice Presentment and Payment System – The FSC uses a third-party contractor, Tungsten, to transition vendors from paper to electronic invoice submission. Please go to this website: http://www.tungsten-network.com/US/en/veterans-affairs/ to begin submitting electronic invoices, free of charge. Tungsten e-Invoice Setup Information: 1-877-489-6135. Tungsten e-Invoice email: VA.Registration@Tungsten-Network.com. FSC e-Invoice Contract Information: 1-877-353-9791. FSC e-invoice email: vafsccsh@va.gov

b. VA system that conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) chartered by the American National Standards Institute (ANSI). The X12 EDI Web site (http://www.x12.org)

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

B.2 SCHEDULE OF ITEMS

See Attachment D.2 - Schedule of Items

This is a fixed-price Indefinite Delivery, Indefinite Quantity (IDIQ) contract issued in accordance with FAR 16.504. The contract’s minimum guarantee is $175,000.00. The contract’s maximum spend (ceiling) shall not exceed $98,500,000.00.

B.3 STATEMENT OF WORK (SOW)

MIDCON CUSTOM STERILE PROCEDURE PACKS

Introduction

The U.S. Department of Veterans Affairs (VA), Veteran Integrated Service Networks (VISNs) 5, 9, 10, 12, 15, 16, and 23, has a requirement for an ongoing supply of Custom Sterile Procedure Packs and associated services for an estimated 35 VA Medical Centers and Community Based Outpatient Clinics (CBOCs). The number of participating VA facilities may change based on the Government’s needs. The Contractor shall be responsible for providing all labor, materials, transportation, storage, equipment, supervision, quality assurance, electronic communication, order reporting, and delivery of the packs. The Contractor shall maintain compliance with federal, state, and local regulations to provide custom sterile procedure packs and creation of new packs, as deemed necessary for the participating medical facilities.

Period of Performance

The period of performance for this contract is one (1) five-year period with five (5) pricing periods.

Five (5) Year

May 1, 2025 through April 30, 2030

Delivery Locations and Delivery Schedule

Delivery Locations: All components for Custom Sterile Procedure Packs shall be delivered to VA Medical Centers, VA Health Care Systems, or VA Community Base Outreach Clinics identified in Attachment D.1 - Delivery Locations. The number and location of VA facilities located within these VISNs may increase or decrease based on the Government’s need to provide healthcare to Veterans.

Delivery Schedule: Delivery days and times are Monday through Friday (M-F) between the business hours of 8:00 a.m. - 3:30 p.m. local time, Federal Holidays excluded. Any delivery service performed outside of these delivery hours must be approved in advance by the local VA facility’s Contracting Officer Representative (COR). Attachment D.2 - Schedule of Items lists the types of custom sterile procedure packs along with the estimated annual number of cases for each pack. This is an estimate only, not a guarantee. The types of custom sterile procedure packs and the quantity needed may increase or decrease based on Veterans needs.

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

*When a Federal Holiday falls on a Sunday, the following Monday shall be observed as a Federal Holiday. When a Federal Holiday falls on a Saturday, the proceeding Friday is observed as a Federal Holiday by U.S. Government agencies.

**This list will also include any other day specifically declared by the President of the United States of America to be a Federal Holiday.

Abbreviations and Definitions

Abbreviations

Definitions

Component: A component is an item or set of items in a pack, used in a procedure for the benefit of the patient or clinician. Components are not defined as material required, while maintaining the integrity of the package.

Contractual Exception: Packs not shipped due to manufacturer’s backorder, manufacturer’s recall, manufacture’s discontinued items. Packs for which delivery is excusable as set forth in FAR 52.212-4(f).

Custom Sterile Procedure Pack Program (Custom Packs): Custom pack programs are designed to develop individualized procedure packs to save on operating room start-up times, cut down on the time between patients, and create standard practices that result in hospital effectiveness, efficiency, and charge/cost capture.

Fill Rate: Rate in which ordered products are delivered within contracted delivery time. The calculation for fill rate will be (Items Delivered/Items Ordered). The fill rate is applicable to all approved full production custom sterile procedure packs.

First Article Pack: FAR Part 9.3 states First Article approval ensures that the Contractor can furnish a product that conforms to all contract requirements for acceptance. First article packs shall be at no cost to the Government.

Manufacturer Back Order (MBO): A physical order placed by the Custom Sterile Procedure Pack contractor to a product supplier, and which is not shipped to the Custom Sterile Procedure Pack Contractor from the product supplier within thirty days.

New Pack: A brand-new pack that is required of the medical facility that is newly configured.

Pack Conversion: A reconfiguration of an existing pack.

Packs Partially Filled: Includes any packs where the quantity delivered is less than quantity ordered.

Packs Totally Filled: Includes an order for which all packs ordered were delivered.

Piggyback: Component part that is affixed to the outside of the custom sterile procedure pack due to the inability to include it inside the pack (i.e., unique sterilization requirements).

Short-Dates/Short=Dated Product: Any product delivered with an expiration date less than twelve months from date of delivery.

Short-term Component Delays: Components that are unavailable for a period of ninety (90) days or less. These items may be substituted during the delay period or removed from the pack at the ordering facilities discretion and as approved by the local COR. If packs are built without a component or acceptable substitute, the contractor shall provide a discount on the price of the pack, greater than or equal to the cost of the component not included.

Long-term Component Delays: Components that are unavailable for a period greater than ninety days shall be removed from the custom pack and the Contractor shall work with the impacted VA to update the BOM, pricing, and submit to contracting for contract modification.

Ordering Processes

Ordering Officers: Ordering Officers (OOs) will be authorized to place orders under this contract. The Contracting Officer (CO) will furnish the Contractor with the names of individuals authorized as OOs to place orders against the contract by a separate Ordering Officer Appointment letter 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 and may not negotiate contract prices or terms and conditions. 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. Orders will be placed via Electronic Data Interchange (EDI). EDI capabilities should be fully operational within 30 days of the contract’s performance period start date. If, during the first 30 days of the period of performance the vendor is not capable of accepting orders via EDI, the vendor may accept orders via email.

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 (LIN) series outlined in the Schedule of Items identified in the awarded contract. The quantities given in the solicitation are estimates only. There is no expressed or implied guarantee that these quantities will be purchased. The actual quantities ordered by the facilities will vary based on the medical needs of each facility. If orders are not placed via EDI, the order form shall contain at a minimum the following information:

Date of Order Contractor Name Contract Number and Purchase Order (PO) Number VA Facility Name Line-Item Number (LIN), subline item number (if applicable) Custom Sterile Procedure Pack Description Quantity Ordered Unit Price Total Amount Place of Delivery or Performance Obligated Delivery/Purchase Order

The Contractor shall accept orders until 12:01 p.m. Local VA Facility Time, M-F, 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 two (2) hours of order placement for non-emergency deliveries

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

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 any service-related issues or problems within 24 hours.

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

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

Customer Service Number: _______________________ Customer Service Email: _________________________

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 periods. 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.

Contractor Tasks and Responsibilities

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

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

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

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

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

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

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

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

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

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

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

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

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

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

All custom packs shall be free of debris and particulates.

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

Components

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

The substitution or changing of these specific items after award would require the changing of instruments or equipment to utilize the alternative item. The product line shall highlight the equal/substituted item on the Item Content List and be approved by the medical center prior to substitution. The Contractor shall assist the facility staff with ordinary questions and information regarding product exchanges and substitutes.

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

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

All custom pack components and wrappings shall be Latex Free unless specified otherwise by the using facility. All latex-free custom packs shall be labeled as “Totally Latex Free” on the outside covering. If there is a required substituted item, it shall be on the outside of the pack (piggybacked) and that latex item shall be clearly labeled in red.

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

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

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

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

Gowns shall fit and allow freedom of movement.

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

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

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

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

Unavailability of Component Parts

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

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

List of packs affected by unavailability.

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

Contract and Purchase Order number.

Reason for unavailability.

Length of time the component will be unavailable.

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

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

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

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

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

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

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

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

Component Deletions or Long-Term Substitutions:

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

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

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

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

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

When an acceptable component substitution is unavailable and VA authorizes a pack to be built without components, the Contractor shall track the component deletions, the price of each component, and the quantity of components deleted for each custom pack. This information shall be supplied as part of the Monthly Substitution Report. The Contractor shall sum and credit each VA facility for the missing/deleted components not included in an ordered custom pack.

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

Manufacturer Backorders: The Contractor shall notify the COR, VA PM, and 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 aid the Contractor and sub-contractor, and the participating customers during the MBO period.

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

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

Packaging

Unless otherwise specified in the statement of work, the product shall be packed in substantial containers of the type, size and kind commonly used within the industry for this purpose. The container(s) shall be constructed as to ensure acceptance and safe delivery by common carriers to the point of delivery designated by each medical facility. Items shall be packaged adequately to prevent deterioration and damage during shipping, handling, and storage. All latex-free packs shall be labeled on the outside as Totally Latex-Free. If there is a required substituted item, it shall be on the outside of the pack (piggybacked) and that latex item shall be clearly labeled in red.

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

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

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

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

Package content quality is the responsibility of the Contractor, including items affixed to the outside of the pack (piggyback) and distributed as a part of the pack. Any pack determined to be defective (e.g., contains expired components, sterility has been compromised, etc.), through no fault of the Government, shall be returned to the Contractor. at the contractor’s expense or disposed of with the vendor’s approval. Upon notification of a defective pack, the contractor shall issue a replacement or credit/refund within five (5) business days of receipt of the notification. The decision to receive a replacement or credit/refund shall be made by the ordering officer or COR.

Quality Assurance

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

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

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

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

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

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

Packaging and labeling specifications, including methods of processes used.

Sterilization requirements and methods.

Testing requirements and methods.

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

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

The Government may, at its option and expense, inspect the contractor and/or sub-contractor’s manufacturing and distribution centers at least annually and will give the contractor a written request five (5) business days prior to the inspection.

Delivery Requirements

Delivery Acceptance: All deliveries are FOB Destination to the VA (see Attachment D.1 - Delivery Locations). Supplies shall be delivered to the destination’s warehouse unloading platform or receiving dock at the expense of the Contractor. The Contractor is required to provide a legible signed and/or electronic delivery slip/ticket that has been signed and dated by the deliverer as well as countersigned by the VA facility representative supervising the delivery; proof of delivery shall be available upon request. 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 a 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 furnishes tailgate delivery, when required, if transfer to truck is required to complete delivery to consignee.

Delivery of Orders: Custom Pack deliveries shall be made within three (3) business days upon receipt of an individual delivery order issued by an authorized ordering officer.

Emergency Deliveries: Emergency deliveries, if required, shall be delivered within twenty-four (24) hours M-F during normal business hours. The contractor shall delivery on Holidays and weekends, only as requested by the local COR.

Shipping: In accordance with DOT requirements, if a pack contains chemicals, a Safety Data Sheets (SDS) shall be provided if requested by the COR or the ordering officer.

Prices listed on Attachment D.2 – Schedule of Items will be all-inclusive prices. Additional charges such as delivery fees, handling fees, administrative fees, hazardous material fees, fuel charges, taxes, storage, tracking fees, etc. shall NOT be billed to or collected from the VA for orders placed against this contract.

Missing/Deleted Pack Component Credits: Each VA facility has a Line Item Number (LIN) on the Schedule of Items for the missing/deleted pack component(s) credit. No later than the 13th calendar day of the following month, the Contractor shall sum the total price of components deleted from custom packs by VA facility and issue a credit to a corresponding PO using the appropriate Credit LIN. Prior to issuing a credit, the Contractor shall contact the appropriate VA Ordering Officer and COR so that the ensuring PO number can be created with the credit line item and amount. The Contractor shall add the PO number and credit amount to the Monthly Status Report to ensure all credits are applied in accordance with sections 6.5.6. and 15.1.1.6. The monthly missing/deleted component report shall be submitted no later than the 20th day of each month.

Inventory Management

The contractor shall have written inventory controls to ensure custom surgical pack orders are fulfilled while also remaining lean to prevent risk of obsolesce and over stock.

The contractor shall have a minimum of 30 days but no more than 45 days of stock-on-hand for each active line item. Replenishment of inventory shall occur within 15 business days after orders are placed. Delays in inventory replenishment shall be communicated to the local COR and the Custom Packs VA Program Manager (PM).

The contractor shall calculate initial days of stock-on-hand by dividing the estimated annual usage, provided by the government (in the schedule of items) by the number of months within the calendar year. This equation will provide a baseline for the required days of stock on hand by establishing an estimated monthly usage (EMU). When the equation results in a number less than one (1), the minimum requirement shall be one (1).

Adjustments to the EMU shall be made on an ‘as needed’ basis by local CORs. The adjustment requests shall be written, include current LIN information, the current EMU, the new EMU and be signed by the local COR. Requests will be reviewed by the Contractor to determine if there is any impact to contract pricing. If contract pricing is unaffected, the Contractor will sign off in concurrence and adjust the EMU. After both parties have signed off on the EMU adjustments, inventory levels will be adjusted by the Contractor within 30 days.

Adjustments that impact LIN pricing shall only be made during quarterly modifications and must be approved by the CO.

The vendor shall have inventory controls in place to track the expiration dates of the custom pack inventory. If at any time active inventory has less than 180 days shelf life, the contractor shall notify the ordering facility electronically.

The vendor shall provide weekly inventory reports as required in section 15.2 of the SOW. Each VA facility report shall include a rolling quarterly snapshot of usage by pack to identify trends in usage and aid the VA in making necessary adjustments to EMUs.

The Contractor’s Customer Service Representative (section 13 of the SOW) shall work with each VA facility to determine an accurate estimated monthly usage not to exceed forty-five (45) day inventories. The Government will be responsible for purchasing any unutilized custom sterile procedure packs not to exceed forty-five (45) days of inventory.

Fill Rate

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 monthly fill rate reports to the CO and PM. The PM or designee shall independently verify the Contractor’s fill rate based on utilization data. The monthly fill rate report will be broken down by ordering facility and be submitted by the 10th calendar day of each month. If a fill rate falls below 97% during the monthly reporting period, the Contractor shall conduct a root cause analysis and submit a corrective action plan to the VA PM no later than 10 days following the submission of the monthly report.

Fill-Rate calculation is based on complete orders delivered within three (3) business days for non-emergency orders.

Fill-Rate calculation is based on complete orders delivered within twenty-four (24) hours for emergency orders.

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

Transition

Within seven (7) business days after the date of contract award/effective date, the Contractor shall provide a clear and finalized transition plan in writing, which shall include a project management plan with specific goals and a schedule of significant milestones.