36C26324Q0898.docx

SUBJECT*

Radioisotope Cardinal Contrast RadioPharmaceutical Supplies

GENERAL INFORMATION

SET-ASIDE

Fargo VA Health Care System

Sioux Falls VA Health Care System

2101 Elm St. N / 2501 W 22nd Street

Fargo / Sioux Falls ND / SD

CONTACT INFORMATION

NETWORK 23 CONTRACTING OFFICE

Contract Officer 4801 Veterans Drive St. Cloud MN 56303

POINT OF CONTACT*

Contract Specialist Emanuel Nevarez emanuel.nevarez@va.gov (320)255-6354

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

DESCRIPTION

This is a Notice of Intent published in accordance with Federal Acquisition Regulation (FAR) 5.101(a)(1) requiring the dissemination of information regarding proposed contract actions. This Notice of Intent is for a proposed award of a sole source firm fixed price contract to the following contractor in support of needed Radiopharmaceutical Products for the Fargo VA Healthcare System 2101 North Elm Street, Fargo, ND 58102 and Sioux Falls VA Health Care System 2501 W. 22nd Street, Sioux Falls, SD 57105:

Cardinal Health 414, LLC

SAM UEI: CWN9UGL3NCL9

7000 Cardinal PL Dublin, OH 43017, United States

This is done under authority of 41 U.S.C. 3304(a)(1), as implemented by FAR 6.302-1: Only one source and no other supplies or services will satisfy agency requirements.

This is not a request for competitive quotes.

Market research revealed that Cardinal Health 414, LLC is the only company that is able to maintain and support the needed Radiopharmaceutical Products at the Fargo VAHCS and Sioux Falls VAHCS.

Additionally, Cardinal Health 414, LLC has a radiopharmaceutical pharmacy in South Dakota and Minnesota capable of providing these items in accordance with the stringent delivery requirements.

The North American Industry Classification System (NAICS) code for this service is 325412 (Pharmaceutical Preparation Manufacturing) and the Product Service Code (PSC) is 6505 (Drugs and Biologicals).

While this synopsis does not constitute a solicitation, interested vendors may identify their interest and capability to satisfy the requirement, including documentation from the proprietary rights holder Cardinal Health 414, LLC that such contractor could provide this service as an authorized reseller, authorized dealer or third party.

All responsible sources may submit a capability statement, which shall be considered by the agency by e-mailing such statement and supporting documentation to Emanuel Nevarez, Contract Specialist emanuel.nevarez@va.gov. Please indicate “36C26324Q0898 Radioisotope Cardinal Contrast” in subject line of e-mail.

Such documentation will be reviewed solely for the purpose of determining whether or not to conduct the procurement on a competitive basis. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government under authorities cited above.

See Attached Statement of Work (SOW) Presolicitation Notice Presolicitation Notice

Presolicitation Notice

B.3 STATEMENT OF WORK (SOW)

Radioisotope Cardinal Contrast General Overview

The Fargo and Sioux Falls VA Health Care Systems requires Radiopharmaceutical supplies for patient imaging.

Place of Performance / Deliveries

Fargo VA Health Care System Nuclear Medicine 2101 Elm St. N Fargo, ND 58102

Sioux Falls VA Health Care System 2501 W 22nd Street Sioux Falls, SD 57105

1. For routine orders placed and delivered Monday through Friday between the hours of 7:00 a.m. to 5:00 p.m., delivery shall be made within 24 hours after receipt of telephone order from a designated individual in the Radiology Service prescribed below.

2. Emergency weekday orders placed between the hours of 7:00 a.m. to 5:00 p.m. Monday through Friday shall be delivered within 60 minutes after the vendor's receipt of the telephone order. All orders must be confirmed within 30 mins of receipt of order.

3. Emergency orders placed weeknights, weekends and holidays shall be delivered within 2 ½ hours after the vendor's receipt of the telephone order. All orders must be confirmed within 30 mins of receipt of order.

4. Authorized Ordering Individuals: Orders may be placed by telephone by one of the following: Fargo VA functions:

a. Nuclear Medicine Technologies, Imaging Supervisor

b. Nuclear Medicine Physicians

Period of Performance

Period of performance dates:

Base Ordering Period: 10/01/2024 - 09/30/2025 Ordering Period 1: 10/01/2025 - 09/30/2026 Ordering Period 2: 10/01/2026 - 09/30/2027 Ordering Period 3: 10/01/2027 - 09/30/2028 Ordering Period 4: 10/01/2028 - 09/30/2029

Radiopharmaceutical Products

The contractor shall provide Fargo and Sioux Falls Medical Facilities the following Radiopharmaceutical products.

1. Ultratag Vial

2. Sincalide Vial

3. Aerotech 1 Aersol Nebulizer Kit

4. Ba133 E Vial 250uCi

5. Survey Meter Calibrations

6. Co-57 E Vial 5mCi

7. CO-57 29"x18" RFS 10mCi

8. Co-57 Spot Marker 50uCi

9. Ga-67 Gallium Citrate UD

10. Sealed source inventory

11. Hetastarch 6% 10ml vial

12. Heparin Sodium 1000 IU/ml 1ml vial

13. I-123 USP NaI 200 uCi Cap

14. In-111 Pentetreotide UD (Octreo)

15. In-111 Autologous WBC Suspension

16. Pyrophosphate Vial

17. Sincalide Solution UD-(dose)

18. Sincalide Solution UD-(0.02ug per kg)

19. Tc-99m Exametazime UD

20. Tc-99m Filtered Sulfur Colloid UD

21. Tc-99m Tilmanocept UD syringe

22. Tc-99m Macro Aggregated Albumin UD

23. Tc-99m Mebrofenin UD

24. Tc-99m Medronate UD

25. Tc-99m Mertiatide

26. Tc-99m NaTcO4 MD

27. Tc-99m NaTcO4 UD mCi

28. Tc-99m Pentetate UD

29. Tc-99m Sestamibi UD

30. Tc-99m Sulfur Colloid UD

31. Tc-99m Tetrofosmin UD

32. Tc-99m Exametazime WBC's

33. Test Wipes with Backing

34. TI-201 Thallous Choloride UD

35. Wipe Test Smears

36. Tc-99m Cardiolite UD

37. Tc99m-Filtered Sulfur Colloid

38. Lymphoseek Study Dose

39. Cesium-137 vial source 220 uCI

40. co-57 16.5x24 rfs

41. In-111 WBC blood kit

42. In-111 Chloride UD

43. I-123 Ioflupane

44. Iosat Tablets (14 Tabs)

45. Tc99m Pyrophosphate UD

46. secure plus safety insert caps

47. After Hours Callout

48. Non-scheduled delivery

49. After hours delivery

50. Stat Delivery

51. Weekday Delivery 1

52. Weekday Delivery 2

53. Weekday Delivery 3

54. Weekday Delivery 4

55. Weekday Delivery 5

56. Weekend Delivery 1

57. Weekend Delivery 2

Scope of Work

1. The contractor shall be licensed properly to the applicable state (North Dakota, Minnesota, South Dakota) which provides the products to the facility. Additionally, contractor must be licensed by the Nuclear Regulatory Commission and be established in the business of providing radiopharmaceuticals. Offeror must provide copies of these licenses and certifications along with proposal to the Contracting Officer.

2. All products provided under this contract shall meet all requirements of the Nuclear Regulatory Commission (NRC). All products provided under this contract shall be packaged and shipped in accordance with the requirements of the NRC and Department of Transportation (DOT). All products returned will also be packaged in accordance with the requirements of the NRC and DOT. The products under this contract shall meet all requirements under the FDA and United States Pharmacopeia and the National Formulary (USP-NF). Compliance with all OSHA manufacturing, packaging, and shipping regulations is required.

3. The contractor shall guarantee the quality of all radiopharmaceuticals. Quality control shall include percent tag and MO99 breakthrough as appropriate. The Contractor shall conduct Quality Control on each agent dispensed. The Contractor shall guarantee the quality of all radiopharmaceuticals. The Contractor shall provide complete documentation on Quality Control results upon request.

4. In the event the product fails due to half life or any other issue because of transportation issues or delays, the contractor shall replace the product at no cost.

5. The contractor shall provide a quarterly linearity source as listed in the CLIN schedule. The activity requested can range from 25 to 250 mCi. All labeled products shall be LEU-derived radiopharmaceuticals where applicable and available.

6. The Contractor shall provide 24 hours on call service for emergency procedures.

7. The Contractor shall provide documentation of inventory, disposal, and patient dose records, which documents compliance with Nuclear Regulatory Commission (NRC) requirements and Fargo VA HCS NHPP permit/NRC License.

8. The Contractor shall provide the radiopharmaceuticals and estimated quantities listed on the price schedule. Types and quantities of product may change throughout the course of the contract. The contractor will provide a mutually agreeable solution during product shortages. Contractor shall provide notification within 2 days of product change. In the event of a shortage the VA will receive first shipment of all products. Additionally, availability of sealed source and flood phantom purchases as requested.

9. Contractor/supplier shall abide by (CFR 10) Title 10 Code of Federal Regulations, which states: Title 10 Code of Federal Regulations is available at: http://www.nrc.gov/reading-rm/doc-collections/cfr/. A licensee may use for medical use only:

a) Byproduct material manufactured, labeled, packaged, and distributed in accordance with a license issue pursuant to the regulations in Title 10, Code of Federal Regulations, part 30 and SS32.72, or 32.74 of this chapter or the equivalent regulations of an Agreement State:

b) Reagent kits that have been manufactured, labeled, packed, and distributed in accordance with the approval by the Commission pursuant to S32.72 or an Agreement State under equivalent regulations for the preparation of radiopharmaceuticals for medical use.

10. Items must be adequately packaged to prevent damage during handling and storage. All packaging and labeling must meet all federal and state regulations. All packaging of radioactive material MUST BE clearly labeled RADIOACTIVE on the outside of the carton in which it is shipped.

11. Contractor must test all products for Quality Control periodically and only those products that pass quality control may be sent to the VA. This testing shall be performed at no cost to the VA. The contractor will provide a detailed description of the test upon request.

12. Contractor must provide current material safety data sheets in a binder and updates as necessary on all delivered products for each medical center or the contractor must provide their website link where MSDS and package inserts for all radiopharmaceuticals can be read and printed.

13. Contractor must assign to each medical center an individual sales representative to aide in facilitation in the smooth coordination between the medical center and laboratory pharmacy.

14. Contractor may provide appropriate signs and posters alerting patients, employees, and the public, of safety precautions in handling of radioactive materials.

15. Contractor must replace any items delivered in error at no cost to the medical center.

16. Contractor must label all products as to the amount of radiopharmaceutical, preparation time, expiration time and date, etc.

17. Contractor must follow all USP 797 guidelines and provide verification of compliance upon Contracting Officer request.

18. TRANSPORTATION: Contractor personnel, drivers, and alternates, shall be able to read, write, speak, and understand English language fluently. Personnel shall present a neat appearance and be easily recognized as a contract employee by wearing an identification badge that includes the company’s recognized as a contract employee by wearing an identification badge that includes the company’s name/logo and employee name and photograph. Vehicles used during this service shall prominently display the company’s name/logo.

19. Contractor must ensure that courier service/drivers maintain their Motor Carrier Permit, hazardous material license number, certificate of training of couriers (employees), valid state-issued drivers’ licenses, vehicle insurance and registration. The contractor shall be required to maintain a record log of courier deliveries, indicating time and date, number and description of items for each location, along with signatures.

20. The contractor will be responsible for all reimbursement of the original and/or repeat items because of mishandling or loss. RECALLED AND DEFECTIVE PRODUCTS: the Contractor will immediately notify the Contracting Officer of any recalls of product or other important product safety issues. As appropriate, the Contractor will replace and/or reimburse recalled / defective products at no cost to the Government. The Contractor may be liable for costs of processing recalls, i.e. administrative and clinical services to replace recalled / defective products.

21. BACK-UP DOSES: Allowable, but only if 100% refundable.

22. All vehicles are to be insured in accordance with the regulations of the State of Minnesota at the expense of the contractor.

General Requirements

It shall be understood that, throughout performance of the contract, the Contractor’s personnel, while on VA property, shall adhere to all requirements and regulations that govern the VA Health Care System and its property.

The contractor shall not store equipment or materials on the VA facility property. Any damage to VA caused by the contractor shall be repaired to its previous condition, or better, by the contractor at no additional cost to the Government.

Among all other requirements, the VA Health Care System and its property is now entirely smoke-free.

Contractor and their personnel shall follow all U.S. Department of Veterans Affairs (VA) policies, standard operating procedures, applicable laws, and applicable regulations while on VA property. Violations of this may result in citation and disciplinary measures for persons violating the law.

Contractor and their personnel shall wear visible identification at all times while they are on premises.

Possession of weapons is prohibited.

Contractor shall take all reasonable precautions necessary to protect persons and property from injury or damage during the performance of this contract.

Billing / Invoices

1. Payments: invoices are to be submitted monthly, in arrears, for all products delivered during the previous month. Invoices shall be sent to the address as indicated on the purchase order.

2. Contractor must submit a weekly invoice to the COR, in arrears, showing period covered, billing date, name of preparation, quantity, and amount. The invoices shall contain the following information at a minimum:

a. Purchase Order Number

b. Name of Radiopharmaceutical agent and the unit/unit cost

c. Total price

3. Contractor shall add to the invoice the cost of overages. Any cost to replace damaged or incorrect products will be at the cost of the contractor. Replacements must be received within 48 hours of notification by the VA.

4. Billings rendered by the contractor to the VA Health Care Systems for services furnished under the terms of this contract shall be billed in full. Neither beneficiary, his/her insurer, nor any other third party shall be billed.

5. Payments for services will be at the rates specified in the Schedule of Supplies/Services.

6. Payment shall only be made for actual services rendered.

7. Ordering Officers: Ordering officers may be authorized to place orders against this contract.

The contracting officer will furnish the contract with the names of the individuals who are authorized as ordering officers. The ordering officers are responsible for issuing and administering orders placed by this contract. The ordering officers have no authority to modify any terms of the basic contract. Any deviations from the basic contract must be approved in writing by the contracting officer. The contract shall accept orders against this contract only from the contracting officer and authorized ordering officers. Fulfilling orders from persons other than the contracting officer or ordering officer may result in loss or delay in payment for supplies/ services rendered.

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