Combine Solicitation – 65– 501-16-1-5909-0001 Medtronic Mosaic Heart Valves
Notice Type: Combine Solicitation
Posted Date:
Office Address:
Subject: 65-- 501-16-1-5909-0001 Medtronic Mosaic Heart Valves
Classification Code: 65 - Medical, dental & veterinary equipment & supplies
Solicitation Number: VA25815Q0725
Contact:
Description:
Phoenix VAMC
This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. The solicitation number is VA258-15-Q-0725 and is being issued as request for quote (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-83 (Effective 7/02/15). This acquisition is UNRESTRICTED and the associated NAICS code is 339112 and small business size standard is 500 employees.
The Government anticipates awarding a five (5) year firm-fixed price consignment agreement. This RFQ closes on
The Veterans Integrated Service Network 18 (VISN 18) has an ongoing need for
The prices proposed shall not exceed the established
Payment for items furnished under the agreement is applicable only when such items are used (implanted) or the package is opened by the VA. Contractor(s) shall agree to accept the Government Purchase Card as the preferred method of payment.
Consignment Agreement - An agreement for a specified period of time during which the Contractor provides an item to the Government, reimbursement for which is made only if and when the Government makes use of the item. Unused items are returned to the Contractor at the end of the effective period of the agreement without reimbursement or other expense to the Government. The Government assumes no liability for any item(s) assigned to VISN 18 on a consignment basis until a requirement for the item exists and a purchase or delivery order is placed against the agreement. Title for the consigned items shall remain with the contractor until the items are used.
The proposed contract period is for five (5) years, established as a base year plus four (4) options, to begin at the start of fiscal year 2016. Based on the anticipated volume of orders to be issued over the life of the contract, potential offerors are encouraged to provide additional discounts and price reductions from their current pricing schedules.
This request is written with the specification of BRAND NAME OR EQUAL to the currently used items at the participating VAMC's. If any interested potential offerors can meet the below specifications BRAND NAME OR EQUAL to the currently used items, please respond to this solicitation with enough information to demonstrate that these specifications can be met.
Salient Characteristics:
Heart valve disease can disturb the normal flow of blood through the heart. Heart valves can develop one or both of these problems:
o The valve opening becomes narrow (stenotic) - which limits the amount of blood
pumped to the rest of the body.
o The valve does not close completely (valve insufficiency or regurgitation) - which means
that blood can flow backward instead of only forward. Backward blood flow reduces your
heart's ability to pump blood to the rest of your body. This also causes a buildup of back
pressure in your heart and lungs.
Heart Valves are essential components of vital Emergency Surgery capabilities. Because the size of the valve is not known until the heart has been opened, and the defective native valve removed, patient safety requires a full set of heart valves be readily available. Because the need for emergency surgery is, by definition, not predictable, heart valves must be immediately replaced, on an emergency basis, when they have been implanted.
Specific to
The Mosaic valve is used to replace a damaged aortic valve or a damaged mitral valve, depending on the disease condition.
The Mosaic-- Bioprosthesis is obtained from the heart of a pig. A pig's heart anatomy is similar to that of a human heart. The leaflets that control the flow of blood in the Mosaic tissue valve are secured to a flexible frame (stent) for support. The stent is covered with a fine fabric, used to sew the valve into the heart.
Part I, Supplies/Services and Prices/Costs
ITEM NUMBER DESCRIPTION OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
POP Begin:
POP End:
Brand Name or Equal to - Mosaic Std Aortic Stented Bioprosthetic Porcine
305C219 36.00 EA __________________ __________________
POP Begin:
POP End:
Brand Name or Equal to - Mosaic Std Aortic Stented Bioprosthetic Porcine
305C221 36.00 EA __________________ __________________
POP Begin:
POP End:
Brand Name or Equal to - Mosaic Std Aortic Stented Bioprosthetic Porcine
305C223 36.00 EA __________________ __________________
POP Begin:
POP End:
Brand Name or Equal to - Mosaic Std Aortic Stented Bioprosthetic Porcine
305C225 36.00 EA __________________ __________________
POP Begin:
POP End:
Brand Name or Equal to - Mosaic Std Aortic Stented Bioprosthetic Porcine
305C227 36.00 EA __________________ __________________
POP Begin:
POP End:
Brand Name or Equal to - Mosaic Std Aortic Stented Bioprosthetic Porcine
305C229 36.00 EA __________________ __________________
POP Begin:
POP End:
Brand Name or Equal to - Mosaic Std Mitral Stented Bioprosthetic Porcine
310C25 36.00 EA __________________ __________________
POP Begin:
POP End:
Brand Name or Equal to - Mosaic Std Mitral Stented Bioprosthetic Porcine
310C27 36.00 EA __________________ __________________
POP Begin:
POP End:
Brand Name or Equal to - Mosaic Std Mitral Stented Bioprosthetic Porcine
310C29 36.00 EA ___________________ __________________
POP Begin:
POP End:
Brand Name or Equal to - Mosaic Std Mitral Stented Bioprosthetic Porcine
310C31 36.00 EA ____________________ _________________
POP Begin:
POP End:
Brand Name or Equal to - Mosaic Std Mitral Stented Bioprosthetic Porcine
310C33 36.00 EA ___________________ __________________
0012 Contract Period: Option Year One
POP Begin:
POP End:
List Grand Total of Items contained in CLINS 1-17 for Option Year Pricing 1.00 EA ___________________ __________________
POP Begin:
POP End:
List Grand Total of Items contained in CLINS 1-17 for Option Year Pricing 1.00 EA ___________________ __________________
POP Begin:
POP End:
List Grand Total of Items contained in CLINS 1-17 for Option Year Pricing 1.00 EA ___________________ __________________
POP Begin:
POP End:
List Grand Total of Items contained in CLINS 1-17 for Option Year Pricing 1.00 EA ___________________ _________________
GRAND TOTAL __________________
** Quantities listed are estimated and for comparison only and are not guaranteed quantities upon award. Because the size and type of implant is not known until the time of surgery, exact quantities are impossible to determine.
Interested offerors:
All questions must be in writing and submitted one calendar day prior to the closing date of the solicitation to enable the Buyer to respond. Questions not received within this timeframe may not be considered. The Government reserves the right to not answer questions not meeting this timeline if doing so would result in an amendment requiring an extension of the solicitation and to extend would not be in the best interest of the Government.
The selected Offeror(s) must comply with the following commercial item terms and conditions, which are incorporated herein by reference:
(FAR CLAUSES)
52.212-4 CONTRACT TERMS AND CONDITIONS--COMMERCIAL ITEMS;
ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS--COMMERCIAL ITEMS- Clauses that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.
The following clauses are incorporated into 52.212-4 as an addendum to this contract:
52.252-2 CLAUSES INCORPORATED BY REFERENCE (
http://www.acquisition.gov/far/index.html
http://www.va.gov/oamm/oa/ars/policyreg/vaar/index.cfm
52.204-9 Contractor Access to Government Facilities
52.216-18 Ordering
52.216-19 Order Limitations
52.216-22 Indefinite Quantity
52.217-8 Option to Extend Services - temporary extension
52.217-9 Option to Extend the Term of the Contract
52.225-1 Buy America Act - Supplies
52.232-18 Availability of Funds
52.232-37 Multiple Payment Arrangements
52.232-40 Providing Accelerated Payments to Small Business Subcontractors
52.242-13 Bankruptcy
(VAAR CLAUSES)
852.203-70
852.211-73 Brand Name or Equal
852.232-72 Electronic Submission of Payment Requests
852.246-71 Inspection
852.232-72 Electronic invoice
852.246-70 Guarantee
852.246-71 Inspection
852.270-1 Representatives of Contracting Officers
(End of Addendum to 52.212-4)
52.212-5, Contract Terms and Conditions Required To Implement Statutes or Executive Orders.
52.212-1 Instructions to Offerors-Commercial Items
Offeror must complete and return the Price/Cost Schedule (for all line items) electronically to [email protected].
Offeror submitting an equal item must include product literature and documentation for an equal determination based on the following salient characteristics:
(ADDENDUM TO 52.212-1)
52.252-1
http://www.acqusition.gov/far/index.htms
http://www.va.gov/oamm/oa/ars/policyreg/vaar/index.cfm
(FAR PROVISIONS)
52.209-5 Certification Regarding Responsibility Matters
52.211-6 Brand Name or Equal
52.216-27 Single or Multiple Awards
52.225-18 Place of Manufacture
(VAAR PROVISIONS)
852.211-72 Technical Industry Standards
852.252-70 Solicitation Provisions or
852.270-1 Representatives of Contracting Officers
852.273-74 Award Without Exchanges
(End of Addendum 52.212-1)
52.212-2 Evaluation-Commercial Items
The provision at 52.212-2, Evaluation -- Commercial Items -Lowest Price Technically Acceptable. This is a competitive Request for Quote (RFQ) that represents the best value to the Government conducted under FAR Part 15, Lowest Price Technically Acceptable (LPTA) source selection process. An Award will be made based on the lowest priced quote meeting or exceeding the salient characteristics for non-cost factors.
52.212-2 Addendum includes the following to paragraph (a): The Government will evaluate each quote strictly in accordance with its contents. A quote that is unrealistic in terms of technical quality or price will be deemed reflective of an inherent lack of technical competence or indicative of failure to comprehend the complexity and risks of the contractual requirements. Such quotes may be determined unacceptable. Award will be made to the lowest-price, technically-acceptable offeror. Award will be made to the offeror that presents the quote that possesses all of the following characteristics:
(1) meets the acceptability standards,
(2) conforms to the solicitation,
(3) determined acceptable to the Government,
(4) is from a responsible (as defined in Federal Acquisition Regulation Part 9) offeror,
and (5) has the lowest price of those offerors meeting the first four characteristics listed here.
Except for communications conducted for the purpose of minor clarification, the Government intends to evaluate quotes and award a contract without discussions. Therefore, each initial offer shall contain the offeror's best terms from a technical and price standpoint. However, the Government reserves the right to conduct discussions if it is later determined by the Contracting Officer to be necessary
The factors are listed in descending order of importance.
TECHNICAL ACCEPTABILITY AND PRICE:
1. Technical acceptability:
Technical acceptability of the items offered to meet the Government's requirement. Salient characteristics:
2. Price: Prices will be evaluated for fair and reasonableness.
Offeror shall provide all items in the Price/Cost Schedule, "Brand Name or Equal to"
(End of 52.212-2 Addendum)
FAR 52.212-3 Offeror Representations and Certifications- Commercial Items
STATEMENT OF WORK
FOR
MEDTRONIC MOSAIC PORCINE HEART VALVE BIOPROSTHESES
The
The Contractor shall furnish all supplies listed in Part I, Supplies/Services and Prices/Costs on a consignment basis to the VISN 18 VAMC's in accordance with the terms and conditions of this consignment agreement. Items as listed shall be placed at the participating
The associated North American Industrial Classification System (NAICS) code for this procurement is 339113, with a small business size standard of 500 employees.
The requested items are to be provided to Veterans referred by the VA Southwest Health Care Network (VISN 18) to include
Consignment Agreement - An agreement for a specified period of time during which the Contractor provides an item to the Government, reimbursement for which is made only if and when the Government makes use of the item. Unused items are returned to the Contractor at the end of the effective period of the agreement without reimbursement or other expense to the Government.
The Government assumes no liability for any item(s) assigned to VISN 18 on a consignment basis until a requirement for the item exists and a purchase or delivery order is placed against the agreement. Title for the consigned items shall remain with the contractor until the items are used.
Payment for items furnished under the agreement is applicable only when such items are used (implanted) or the package is opened by the VA. Contractor agrees to accept the Government Purchase Card as the preferred method of payment.
The contractor shall assign a representative to the facility to initiate and oversee the consignment inventory.
NCO 18 contracting officers and VISN 18 purchasing agents are authorized to issue orders under this agreement.
The C&A requirements do not apply, and that a Security Accreditation Package is not required.
Contracting Officer's Representative (COR) - Individual or Individuals designated by the Contracting Officer to place orders, furnish technical guidance, advice, certify invoices, and provide general supervision of the work performed under the executed agreement. This definition is not to be construed as authorization to interpret or furnish advice and information to the Contractor relative to the financial or legal aspects of the agreement. Enforcement of these segments is vested in and is the responsibility of the Contracting Officer. The COR and/or the Contracting Officer will be the only VAMC'S personnel authorized to request services under this agreement.
The Contractor shall deliver FOB destination, the supplies on an as needed basis when requested by the Contracting Officer or his/her designee. Only the Contracting Officer or designee will be authorized to coordinate and request consignment items direct from the Contractor.
General Requirements:
1. Initial Inventory: The products listed on the Schedule represent the products that must be available for the initial inventory. The products shall be placed at the designated location(s) within the time specified, or if no time specified, no later than five (5) calendar days after receipt of the fully executed contract. Each facility will provide adequate space/shelving for stocking these products. The contractor will provide a complete listing of model and part numbers to the contracting officer's representative (COR) upon delivery of the initial inventory.
2. Inventory Level: All consignment inventories will be coordinated with the COR. The contractor agrees to coordinate with the COR to maintain the inventory level of product at all times. At no time shall the number of products held on consignment fall below the minimum quantity specified without the concurrence of the COR. If it is discovered that the stock quantities fall below the agreed minimum stock level, the contractor must replenish the stock level with like quantities of items within 48 hours at no additional expense to the Government.
3. Inventory Management: the designated contractor's representatives assigned to each facility will periodically (no less than quarterly) conduct a physical inventory of the consignment inventory and the results shall be detailed in a report to the COR. At a minimum, the report will contain stock utilization and levels and recalled/outdated items found and removed. The excess unused items will be returned to the contractor at the end of the term of the contract without reimbursement or other expense to the Government.
4. Replacement Products: Each facility will withdraw products from the consignment stock on a first-in first-out basis. After each procedure, the contracting officer/purchasing agent will issue an order with an associated purchase order (PO) listing the products used and the contractor will replace these products within the time specified. If no time specified, delivery shall be within five (5) days. The COR shall be notified prior to the products being replaced. Replacement products will be shipped/delivered FOB Destination directly to the requesting location at no additional cost to the Government. The PO will serve as authorization for delivery of replacement items and payment for the item(s) used. The contractor shall reference the PO number on the invoice and delivery ticket for the replaced products.
5. Product Sterilization: The contractor shall replace any items that are handled but not implanted. The handled items shall be picked-up or shipped back to the sterilization facility. These sterilization services shall be performed at no additional cost to the Government.
6. Alteration of Quantities: The contractor agrees that the total quantity of items furnished under the agreement can be changed at any time during the effective period of the agreement. The contractor agrees that from time to time, the COR may change the number of items on consignment, by written or oral request. The COR must coordinate with the contracting officer and follow-up all oral requests with written confirmation within 24 hours.
7. Defective Products: The contractor shall replace defective products according to the delivery schedule of the agreement at no additional cost to the Government, unless the facility has misused or lost the product.
8. Expiring Inventory: Inventory having less than 90 days sterility/expiration date must be removed and replaced. The contractor shall provide a list of all the expired products to the COR. VISN 18 is not liable for devices that are allowed to expire. These services will be completed at no additional cost to the Government.
9. Expiration/Termination of Agreement: Upon expiration/termination of the agreement, VISN 18 will reconcile all consignment stock units. The contractor will remove all unused items at the end of the effective period of the agreement without reimbursement or other expense to the Government.
10. Delivery Schedule: The vendor shall contact the COR (or COR designee) at the VA to coordinate the delivery of the products. The specific time to be scheduled for the delivery of the products shall be during normal working hours,
Unit pricing:
The unit price for each item/implant shall remain the same, as identified in Part I, Supplies/Services and Prices/Costs, throughout the term of this Agreement. The prices proposed shall not exceed the established Medicare L-Code prices applicable to the geographic area subject to this solicitation and at the time of performance. The equipment price shall also remain the same throughout the terms of this agreement.
Initial Inventory Levels:
An initial consignment inventory is indicated in the schedule; however, this level may be changed by written notification of the Contracting Officer. Initial consignment inventory shall be placed in the participating Medical Center(s) within ten (10) calendar days after receipt of Notice of Award.
Products for Initial Inventory at each participating VAMC:
Product Model QTY
Mosaic Std Aortic Stented Bioprosthetic Porcine 305C219 1
Mosaic Std Aortic Stented Bioprosthetic Porcine 305C221 1
Mosaic Std Aortic Stented Bioprosthetic Porcine 305C223 1
Mosaic Std Aortic Stented Bioprosthetic Porcine 305C225 1
Mosaic Std Aortic Stented Bioprosthetic Porcine 305C227 1
Mosaic Std Aortic Stented Bioprosthetic Porcine 305C229 1
Mosaic Std Mitral Stented Bioprosthetic Porcine 310C25 1
Mosaic Std Mitral Stented Bioprosthetic Porcine 310C27 1
Mosaic Std Mitral Stented Bioprosthetic Porcine 310C29 1
Mosaic Std Mitral Stented Bioprosthetic Porcine 310C31 1
Mosaic Std Mitral Stented Bioprosthetic Porcine 310C33 1
Consignment Item Ownership/Title:
The Contractor shall maintain ownership of all consigned items and related supplies furnished under this Agreement, until such time that the Government uses (implants) the consigned item.
Government Safeguarding of items on Government premises:
The Government is responsible for storing the consignment items and for using the items as indicated by product labeling. Once used, the Government orders a replacement and is invoiced at the contract price for the replacement product. The Government will provide proper storage and security for all items supplied hereunder and is responsible for all expenses incidental to the safekeeping and security of items on Government premises.
Contractor Liability:
The Contractor shall not be held liable for any consignment item that has been without question damaged, misused, or lost by Government. If the Contractor damages the item, or the item is defective, it shall be replaced by the Contractor, with no re-stocking fees of any kind assessed upon the
Government Liability:
The Government assumes no liability for any items assigned to the participating VAMC's on a consignment basis until such time as a requirement for the item exists, a consignment item is used, and a purchase (delivery) order is placed against this consignment agreement. If an item has been opened by the Government and/or damaged or cannot be re-sterilized, the item will be purchased by the VAMC.
Consignment Expiration/Termination:
a) All unused, unopened and undamaged items will be returned to the Contractor at the end of the term of this agreement, or cancellation of this agreement, without reimbursement or any additional expense to VAMC'S. Contractor shall be responsible for all shipping costs associated with their return.
Modifications:
Changes to the contract will be made with mutual consent of both parties.
Consignment Items Rotation:
Contractor shall remove and/or replace items from consignment inventory as necessary. Such items may have 90 days or less remaining before the sterility expiration date or have been in inventory for 90 days or more. COR shall be advised prior to any inventory item(s) being removed or replaced; upon removal or replacement of that item, the COR will sign receipt for that item. These services will be completed at no cost to the Government.
Payment/Replacement:
As consignment items listed under Supplies/Services and Prices/Costs are used, a purchase order will be placed by the Contracting Officer/Purchasing Agent with the Contractor within 24 hours of its use, at the price listed in Supplies/Services and Prices/Costs. This purchase order will authorize payment for the used item(s) and will also authorize delivery of the replacement item(s). The purchase order shall be referenced on the invoice and delivery ticket for the replaced items. All replacement items shall be delivered within forty-eight (48) hours from receipt of purchase order. Replacement of consignment items is through the contractor's Customer Service department by providing a purchase/delivery order number including model, size and serial number, for the consignment items and quantities needed. Contractor will be paid only after consigned item(s) is/are used (implanted) by the Government, at the replacement cost indicated in this agreement. Purchase orders and/or Government credit card may be issued/used for ordering and payment.
Payment Procedures:
Contractor must accept the Government Purchase Card as a form of payment IAW procedures outlined in the Continuation of SF 1449 section.
Inventory Sign In/Out Process:
The VAMC'S will develop an inventory accountability process, whereby each and every consigned item shall be accounted for. Contractor shall log each item that they place or remove from the consignment inventory; the item's disposition shall be logged, dated and double signed (Contractor's signature and the COR's signature or COR's designee). COR will log the item's disposition each time an item is removed from inventory. This log sheet shall consist of (at a minimum) the following information:
a. Date
b. Item Description
c. Item serial number (or identification number)
d. Description of item disposition (Narrative stating what happened to the item)
e. Printed Name and Title of person who placed or removed the item
f. Signature of item "e" above
g. Counter signature (including Printed Name and Title) if required
Quarterly Reports:
Contractor shall furnish the Contracting Officer a Quarterly Usage/Saving Report, within 30 days of the close of the preceding quarter.
At a minimum, this report shall contain:
a. Contractor's name and contact information
b. Consignment title and number
c. Report date
d. Reporting timeframe
e. Current Reporting period:
i. All implanted models/types including serial numbers
ii. Quantities used since last report
iii. List price (before Agreement)
iv. Contract price and any additional discounted prices
f. Consignment History:
i. Total to date quantity of implanted items, broken down by model types
ii. Running total of amount expended at contracted price
iii. Running total of amount saved from contracted price verses list price
Contractor Inventory Checks:
Contractor shall periodically (at least twice per year) conduct a physical inventory of the consignment items. Inventory results shall be furnished to the COR.
Special Implant Needs:
Occasionally specific patients may require a special implant not available from the consignment inventory. These items will be purchased from any contractor whose pricing is deemed to be fair and reasonable following all Government rules and regulation as they pertain to the acquisition of supplies. Special use items that become routinely used may be added to this agreement by a modification issued by the Contracting Officer.
Defective Consignment Items/Guarantee:
Contractor shall replace defective consignment items or related supplies at no charge to the Government. The consignment items shall be subject to the terms and conditions specified in the warranty information for each individual item. All items will be in proper working condition as required by applicable quality standards.
Technical Support:
Technical support shall be available twenty-four (24) hours a day for patient follow up, in-service training, and/or consultation on technical issues.
Pre-Consignment Inventory:
a. The Contractor shall remove all existing stock items in inventory and issue credit usable against future order(s) placed (a listing of existing inventory will be provided upon request). Contractor shall be responsible for all shipping costs associated with their return to Contractor.
b. A complete listing of model and/or part numbers shall be provided to the Contracting Officer upon delivery of the initial consignment inventory. The VAMC'S will maintain an inventory showing all transactions.
National Provider Identifier (NPI) Information Required:
All Contractors and health care practitioners who provide billable health care services to the
Contract Administration Data:
The Contracting Officer is the only person authorized to approve changes or modify any of the requirements under this contract. The Contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer is authorized to make commitments or issue changes which will affect price, quantity, or quality of performance of this contract. In the event the contractor effects any such change at the direction of any person other than the Contracting Officer, the change shall be considered to have been made without authority and no adjustment will be made in the contract price to cover any increase in costs incurred as a result thereof.
ID Badges/Parking/Smoking Policy:
a. CONTRACTOR SIGN-IN - Contractor personnel shall report to Acquisition and Material Management Service, before visiting the facilities, to sign-in and receive a contractor's security badge.
b. BADGES - All Contractor personnel are required to wear identification (ID) badges during the entire period during which they are on VA grounds. ID badges must show an identification picture, name of the individual, and the represented company.
c. PARKING - It is the responsibility of Contractor personnel to park only in designated parking areas. Parking information is available from the
d. SMOKING - Smoking is not permitted within or around the
END STATEMENT OF WORK
Link/URL: https://www.fbo.gov/spg/VA/PhVAMC/HMC/VA25815Q0725/listing.html
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