Intent to Sole Source - Roche Diagnostics Corp

Statement of Work

Microbiology Laboratory - COVID, HIV, HCV, HPV, CTNG and eGFR reagents

1. Basic Requirement:

The Minneapolis VA Health Care System Microbiology Laboratory, located at 1 Veterans Drive, Minneapolis, MN 55417, hereinafter referred to as MVAHCS, is in need of a contract to provide highly specialized FDA approved COVID, HIV, HCV, HPV, CTNG and eGFR reagents, controls and consumables which must be approved for use our owned Roche COBAS 6800 analyzer and Roche COBAS 480Z analyzer. These items are further specified in the schedule of items.

2. Contract Type and Terms:

The MVAHCS will award a five-year, firm, fixed-price, indefinite delivery indefinite quantity contract for all items listed in the Schedule of Items. Contract use will be limited to the MVAHCS. The effective period of the contract shall be from 10/1/24-9/30/29.

The Periods of Performance will be:

• Base Ordering Period: 10/1/24-9/30/25
• Ordering Period 2: 10/1/25-9/30/26
• Ordering Period 3: 10/1/26-9/30/27
• Ordering Period 4: 10/1/27-9/30/28
• Ordering Period 5: 10/1/28-9/30/29

3. Estimated Quantities:

The quantities listed in the Schedule of Items are estimated annual requirements. The MVAHCS attempts to be as accurate as possible when providing estimated quantities, however, actual quantities required may vary from quantities listed. All products will be requested on an on demand, as needed basis.

Schedule of Items:

Item #

Description

Stock #

Qty

1

KIT COBAS 58/68/8800 WASH IVD

6997503190

146

2

KIT COBAS 58/68/8800 SPEC DIL RGNT IVD

6997511190

48

3

KIT COBAS 58/68/8800 LYS RGNT IVD

6997538190

47

4

KIT COBAS 58/68/8800 MGP IVD

6997546190

76

5

cobas omni Processing Plate

5534917001

45

6

cobas omni Amplification Plate

5534941001

24

7

cobas omni Pipette Tips

5534925001

89

8

Solid Waste Bag With Insert Set of 20

8030073001

20

9

KIT COBAS 6800/8800 SARS-COV-2 480T

9343733190

2

10

KIT COBAS 6800/8800 SARS-COV-2 RMC

9175440190

10

11

KIT COBAS 6800/8800 BUFF NEG RMC IVD

7002238190

10

12

KIT COBAS 58/68/8800 SARS-COV-2 192T IVD

9446109190

4

13

KIT COBAS 58/68/8800 CT/NG 480T IVD

9040501190

12

14

KIT COBAS 58/68/8800 HPV 480T IVD

9040544190

20

15

KIT COBAS PCR URINE 100 PKT IVD

5170486190

20

16

KIT COBAS PCR MEDIA UNI SWB 100 PKT IVD

7958030190

17

17

KIT COBAS 58/68/8800 BUFF NEG RMC

9051953190

36

18

KIT COBAS 58/68/8800 CT/NG RMC IVD

9040510190

22

19

KIT COBAS 58/68/8800 HPV RMC IVD

9040552190

23

20

KIT COBAS 58/68/8800 HCV 192T IVD

9040765190

6

21

KIT COBAS 58/68/8800 HIV 192T IVD

9040803190

8

22

KIT COBAS 58/68/8800 HBV/HCV/HIV RMC IVD

9040773190

18

23

KIT COBAS 58/68/8800 NHP NEG RMC

9051554190

10

24

KIT COBAS EGFR AMP/DET V2 24T IVD

7248563190

4

25

AD-plate 0.3ml

5232724001

6

26

KIT COBAS PCR MEDIA TUBE REPLACEMENT CAP

7958056190

3

27

KIT DNA ISOLATION 24T IVD

5985536190

20

28

KIT COBAS 58/68/8800 SARS-COV-2 RMC

9446117190

1

4. Customer Service/Technical Support:

A contractor representative shall be available to the MVAHCS during the contract period to review the account, provide product information, handle problems or defective merchandise (if required) and address any other issues or concerns that may arise. Technical telephone support must be available Monday through Friday between 8:00am and 5:00pm. Telephone response time shall be within four (4) hours of notification.

5. Ordering Procedures:

Orders will be placed via contractor's preferred method on an on-demand, as-needed basis by the MVAHCS. A list of approved personnel will be provided at the request of the contractor. Contractor shall provide the following preferred ordering information:

Preferred method of ordering: _________________________________

Telephone Number: _________________________________________

Email address: ______________________________________________

6. Delivery

All supplies shall be delivered FOB Destination to the MVAHCS (unless otherwise indicated on the response to the solicitation) and shall arrive at the MVAHCS no later than 5 calendar days after receipt of an order.

Deliveries shall be made to:

VA Medical Center, Bldg. 70

Warehouse (90D), PO# _________

One Veterans Drive

Minneapolis MN 55417

Delivery Times: Between 8:00am and 3:30pm

(Monday-Friday except Federal Holidays)

All deliveries shall be accompanied by a packing slip which shall contain contractor's name, purchase order number, date of order, date of delivery, itemized list of products furnished including product description and quantity shipped.

7. Product Quality

All products offered to the MVAHCS must be of the same consistent high quality as would be offered to the general commercial public in the United States.

1. All products are purchased subject to acceptance by the MVAHCS. Products will be rejected if found unsatisfactory by the MVAHCS when they are received, or later if deterioration of the product occurs before the outdate. The MVAHCS will not be financially liable for unacceptable materials.
2. Any substitutions of product must have the written approval of the MVAHCS and the VISN 23 Contracting Officer.
3. All defective or inferior products must be replaced within 48 hours at no cost to the MVAHCS.
4. The MVAHCS is not required to return unacceptable product.
5. It is the contractor's responsibility to provide the MVAHCS with recall notices on any product that has been delivered to this facility that may be defective. Notification shall be made via the most expedient method. The contractor shall replace and/or reimburse recalled or defective products at no cost to the government.
6. The contractor shall provide MVAHCS with a listing of the contractor's products that are considered hazardous. The listing should also include a determination as to what can be considered harmless to be disposed of by normal methods, such as disposing in the sink or trash. SDS shall be available upon request.
7. To assure rotation of stock at the distributor, each lot of a product received must have an outdate later than previously received.
8. Only one lot number per product may be shipped per order. Multiple lot numbers per product per order will not be accepted.
9. All products must be delivered with at least 2/3 of the shelf-life remaining. The manufacturer will provide a shelf-life list (time from production to outdate), for each product, if requested.

8. Changes/Modifications:

Changes in the pricing, terms or conditions of this agreement may only be made by written agreement of the parties. All modifications for changes in the prices, terms or conditions of this agreement will be prepared for signature by the VISN 23 Contracting Officer.