36C77621R0021_1.docx

DEPARTMENT OF VETERANS AFFAIRS

Veterans Health Administration Regional Procurement Office (RPO) Central, PCAC 212 3rd Ave South, Suite 29 Minneapolis, MN 55401

Contract Opportunity Presolicitation Notice

PRODUCT SERVICE CODE

SUBJECT

CONTRACTING OFFICE'S

ZIP-CODE

SOLICITATION NUMBER

RESPONSE

DATE/TIME/ZONE

ARCHIVE

DAYS AFTER THE RESPONSE DATE

RECOVERY ACT FUNDS

SET-ASIDE

NAICS CODE

CONTRACTING OFFICE

ADDRESS

POINT OF CONTACT

(POC Information Automatically Filled from User Profile Unless Entered)

DESCRIPTION

See Attachment

AGENCY'S URL

URL DESCRIPTION

AGENCY CONTACT'S EMAIL

ADDRESS

EMAIL DESCRIPTION

ADDRESS

POSTAL CODE

COUNTRY

ADDITIONAL INFORMATION

GENERAL INFORMATION

PLACE OF PERFORMANCE

Required Field Contract Opportunity Presolicitation Notice Avid Medical, Inc Brand Name Custom Sterile Procudure Packs 55401 36C77621R0021 02-05-2021 10:00

CENTRAL TIME, CHICAGO, USA

N 339113 Department of Veterans Affairs Program Contracting Activity Central 212 3rd Ave. South, Suite 29 Minneapolis MN 55401 Nicole Kutsi Nicole.Kutsi@va.gov Multiple Locations

PRESOLICITATION NOTICE:

MIDCON CENTRAL REGION CUSTOM PACKS

The Veterans Health Administration (VHA), Midwest Consortium (MIDCON) has a requirement for the ongoing supply of Avid Medical Inc brand name custom sterile procedure packs and associated services for an estimated 26 VA Medical Centers throughout the Veteran Integrated Service Networks (VISNs) 9,10,15,16, and 23. The contractor shall provide Avid Medical Inc brand name custom sterile procedure packs. 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).

A comprehensive list of actual requirements will be included in the attached Statement of Work and within the solicitation document.

The period of performance for this requirement consists of one (1), two (2)-year base contract with ordering periods.

The NAICS code for this procurement is 339113, Surgical Appliance and Supplies Manufacturing and the Small Business Administration (SBA) size standard for this requirement is 750 employees. The proposed requirement action is being procured under full and open competition. Any vendor desiring to be considered for award MUST also be registered in the System for Award Management (SAM) using this NAICS code or a NAICS code with an equivalent size standard. No award can be made unless the vendor is registered in SAM. For additional information and to register in SAM, please access the following website: www.sam.gov. In order to register with the SAM and to be eligible to receive an award from this acquisition office, all offerors must also have a Dun & Bradstreet Number. A Dun & Bradstreet number may be acquired free of charge by contacting Dun & Bradstreet on-line at https://iupdate.dnb.com/iUpdate/viewiUpdateHome.htm. This procurement also requires offerors to complete the electronic representations and certifications at the SAM website.

Any resulting award will be awarded as a firm-fixed price Indefinite Delivery Indefinite Quantity (IDIQ) contract. Solicitation documents will be made available for download on or about February 5th, 2021 at https://beta.sam.gov. Paper copies of this solicitation will not be issued. Each potential quoter is responsible for checking the website to gain all current information related to the solicitation. The solicitation and any further announcements regarding the solicitation will be posted only at https://beta.sam.gov. The date proposals are due will be stated within the solicitation documents and will be adjusted based upon the actual release date of the solicitation.

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

3.1. 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 confirm receipt (via electronic commerce methods) of the request within 48 hours of the notification. If orders are received after 12:00 PM a confirmation shall be received the following day prior to 12:00PM CST.

3.2. 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.

3.3. 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.

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

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

3.5.1. Customer Service Number:_______________________

3.5.2. Customer Service Email:_________________________

3.6. In accordance with contract clause FAR 52.216-19 Order Limitations, if the Contractor does not wish to provide deliveries requested on a delivery order, which are below the minimum order amount or above the maximum order amount as specified herein they shall submit in writing within twenty-four (24) hours of receipt of the delivery order, an explanation of non-intent.

3.7. 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, and must be available on Federal Holidays and weekends. 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 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. The Contractor shall send validation to the Contracting Officer (CO) within 30 days of annual inspection completion.

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. Minor modification of components is defined as removing and/or adding up to and not to exceed three (3) components per pack. 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. ETO tape/indicator is to be affixed to the outer wrap and tray, where applicable. All custom packs should be sterilized in an approved packaging material with a plastic dust cover. Custom packs material must allow the sterilization of the contents, maintain sterility, and provide a way to remove the contents without contamination. Plastic dust covers should be sealed with a method of sealing which results in a complete seal that is tamper evident and allows for ease of aseptic presentation. Accessories used to secure custom packs should be chosen to allow penetration of the sterilization process, avoid constriction of the package and maintain package integrity.

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.

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 and COR 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 5th of each month. In order to track compliance, VA requires the contractor to submit the monthly report of sales in the approved format listed in Attachment (3) Monthly Sales Report Template. 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.

End of Document image1.emf