6525--Radiopharmaceuticals and Associated Supplies

DISCLAIMER

THIS NOTICE IS FOR PLANNING PURPOSES ONLY. THE GOVERNMENT DOES NOT INTEND TO AWARD A CONTRACT ON THE BASIS OF THIS SOURCE SOUGHT OR REIMBURSE ANY COSTS ASSOCIATED WITH THE PREPARATION OF RESPONSES TO THIS SOURCE SOUGHT.

PURPOSE

The purpose of this Source Sought is to conduct market research to find qualified vendors and to assist Network Contracting Office (NCO) 6 in determining if a future contract effort can be competitively awarded for a Set-Aside. The applicable North American Industrial Classification System (NAICS) code assigned to this effort is 325412 Pharmaceutical Preparation Manufacturing the Small Business Size Standard of 1250 employees. If the Government determines there are qualified vendors this requirement, a solicitation will be published and posted on the Contracting Opportunities website. The Government will use this information solely to determine the appropriate acquisition strategy for this procurement.Â

INTRODUCTION

The Salem VAMC has a requirement for a Base plus 4 Option Years for nuclear medicine services to be provided for requested radiopharmaceuticals and associated supplies within 2 Hours of receipt of requirement notification to the Salem VA Medical Center, 1970 Roanoke Blvd, Salem VA, 24153.

Period of Performance:

Base Year 10-01-2024 to 09-30-2025

Option Year #1 10-01-2025 to 09-30-2026

Option Year #2 10-01-2026 to 09-30-2027

Option Year #3 10-01-2027 to 09-30-2028

Option Year #4 10-01-2028 to 09-30-2029

REQUIREMENTS

NOTE: The VHA Network Contracting Office 6 (NCO 6) is conducting a market survey to find qualified vendors who can provide the following item(s) for the Salem VA Medical Center, 1970 Roanoke Blvd, Salem VA 24153:

Radiopharmaceutical and Associated Supplies

SCHEDULE OF ITEMS

Quantities specified represent the Government s best estimate for a year. However, actually quantities may be more or less than specified. Offerors shall provide unit price, total price per line item and, the total estimate cost for the entire year based on pricing offered. Period of Performance 10/1/24 September 30, 2029..

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Description

Quantity

U/I

1

Tc99m MDP

225

DS

2

Tc99m sulfur colloid

60

DS

3

tc99m sulfur colloid filtered

20

DS

4

Tc99m DTPA

70

DS

5

Tc99m Mebrofenin

48

DS

6

Tc99m sestamibi

2386

DS

7

Tc99m PYP

3

DS

8

Tc99m MAA

70

DS

9

Tc99m Mag3

26

DS

10

Tc99m DSMA

0.01

DS

11

Tc99m Exametazine/Ceretec

0.01

DS

12

TcO4 Sodium Pertechnetate Flood Source

8

mCi

13

TcO4 Sodium Pertechnetate

16

DS

14

TcO4 Pertechnetate linearity source

4

EA

15

I123 Caps (200uCi)

20

EA

16

I123 Iofupane

0.01

DS

17

I123 MIBG

1

DS

18

I131 whole body

2

EA

19

I131 Therapy capsule

3

EA

20

In111 DTPA

2

EA

21

In111 Octreoscan

5

EA

22

Ga67 (times activity)

0.01

mCi

23

Tl201

0.01

EA

24

cck (kinevac IV/Sincalide IV)

15

DS

25

PYP cold kit

14

EA

26

Ultratag

0.01

EA

27

Potassium Iodide Tablets

0.01

EA

28

F18-FDG

0.01

DS

29

F18-Pylarify (FSS#36F79719D0170)

0.01

DS

30

F18-Pylarify (FSS#36F79719D0170) cancellation charge (1)

0.01

EA

31

Ga-68 Netspot (FSS #36F79719D0169)

0.01

DS

32

Ga-68 Netspot cancellation charge

0.01

EA

33

Cu64 Detectent

0.01

DS

34

Detectnet cancellation charge

0.01

EA

35

F-18 Vizmyl (PET Dementia)

0.01

DS

36

N-13 Ammonia (PET Cardiac)

0.01

DS

*Radioisotopes with a short half-life (Nl3 and Ga68) require the pharmacy to be within a 30 min drive of the medical center.

DESCRIPTION OF INFORMATION REQUESTED

Vendors with a GSA schedule shall provide the contract number of that schedule and the expiration date as well as product NAICS codes. All items should be clearly identified if they are scheduled items or open market items.

HOW TO RESPOND:

All responses shall be submitted no later than 9:00 am EDT Monday, September 09, 2024. All interested parties should respond, in writing via email to james.risbonva.gov. No telephone inquiries will be accepted. Respondents to this Source Sought shall provide the following information:

Company/individual name,

Address,

Point of contact with phone number

Information describing your interest,

Indicate FSS/GSA contract number or Open Market, as applicable

FSS Category you qualify for

UEI Number

Tax ID number

DUNS number

Capabilities statement

Company Socio-Economic SIZE (example large, small, SDVOSB, VOSB, WOSB etc.)

Authorized Distributor Letter

Interested firms are reminded that in accordance with FAR 4.1201(a) Prospective contractors shall complete electronic annual representations and certifications at the System for Award Management (SAM) as a part of required registration in conjunction with FAR 4.1102(a) that states, Prospective contractors shall be registered in the (SAM) database prior to award of a contract or agreement. Therefore, due to time constraints, vendors must be registered in System for Award Management (SAM) under the above NAICS code at http://www.sam.gov to be considered for an award.

Please submit responses via email in Microsoft Office format by 9:00 am (Eastern Time) 09/09/2024. Please include RFQ # 36C24625Q0015 in subject title.

NOTE: Responses to this announcement will not be returned, nor will there be any ensuing discussions or debriefings of any responses. However, information obtained as a result of this announcement may be reflected in any subsequent solicitation. This announcement is Government market research purposes ONLY.

STATEMENT OF WORK RADIOPHARMACEUTICAL PRODUCTS

Contractor to provide radiopharmaceutical products as listed in Schedule Items in accordance with Public Law 104-262 and 38 USC 8153 for the Department of Veterans Affairs Medical Center, Salem, Virginia.

Quotes that do not contain above requested licenses and certifications will be considered non-responsive and will not be considered for award.

The contractor will provide all radiopharmaceuticals in multi-dose vials or single dose containers as specified.

The contractor will provide a quarterly Technetium-99m sodium pertechnetate dose calibrator linearity source of approximately 350 millicuries in 10ml of saline and in a 10 ml vial.

The contractor will provide, as needed, additional routine radiopharmaceuticals, within two (2) hours of the request during normal duty hours (7:30 AM to 4:30 PM). Salem VAMC can add an additional 1 3 cardiac scans per day. Contractor will need to specify accommodations to meet this need prior to 9:30 AM. STAT doses VQ scan, GI bleeds, Hida, etc. will need to be delivered within forty-five (45) minutes of ordering. The contractor will describe how this requirement will be met in its response to this solicitation.

Contractor will provide forty-five (45) deliveries per month of all items to the Nuclear Medicine Department, 1970 Roanoke Blvd., Salem, VA 24153 at no charge. Pricing for additional deliveries will be noted on price schedule. Contractor will include all radiopharmaceutical preparation and delivery services in the bid price of the individual radiopharmaceuticals and not as a separate item.

Qualifications: Personnel assigned by the contractor to prepare and provide the products covered by this contract shall be licensed in a State, Territory or Commonwealth of the United States or the District of Columbia. The qualifications of such personnel shall also be subject to review by the VA Chief of Staff and approval by the VA Facility Director.

Contractor will provide leukocyte and platelet labeling with radioactive material and will return the labeled cells to the Salem VA Medical Center within one (1) hour of the finish of the labeling process. The entire process must be performed in one (1) day.

The quantity of radioactivity for supplied radiopharmaceuticals will not deviate more than +10% or -5% at the time of calibration, from the quantities specified.

Contractor will perform all quality control procedures on each radiopharmaceutical according to applicable requirements of licensing authorities and other regulating bodies. A copy of the results of the quality control procedures must be made available to the Salem VA Medical Center upon request.

In the event that a quality control or material defect is suspected and/or detected by any Veterans Affairs COTR, the Contractor will be requested to provide any consultation necessary to alleviate any said suspicion and/or defect by the following:

Provide technical expertise in calibration.

Provide professional examination of product; submit results and recommendations to the Contracting Officer.

Make expedient replacement of any product suspected of being deficient.

Contractor shall make quality control records available to the VA Medical Center upon written request from the Contracting Officer.

Contractor will meet all requirements of regulatory agencies for shipment of radioactive drugs between facilities and will strictly adhere to these requirements. Shipments not properly handled according to regulations will not be accepted at the Salem VA Medical Center.

Identification of radiopharmaceutical delivery personnel will be readily verifiable by identification badge including name of employee and contractor.

All radiopharmaceuticals will be ordered by the Nuclear Medicine service at the Salem VA Medical Center on an as needed basis.

Contractor will provide opportunities for continuing education to the Nuclear Medicine technologists at the Salem VA Medical Center on subjects related to radiopharmaceuticals and other topics closely related to radiopharmaceuticals.

Contractor will be responsible for all costs for any radiopharmaceuticals and nonradioactive items contracted for the Salem VA Medical Center must find an alternate supplier for contracted items.

In the event of a manufacturer or pharmacy recall or quality assurance failure, the contractor will notify the VA Nuclear Medicine Department immediately.

A radio-pharmacist in the employ of the successful vendor must be available to:

Set up the quality assurance program on radiopharmaceutical preparations required by FDA, NRC, CAP, USP, and the Joint Commission.

Prepare labeled blood products for reinjection into patients.

Act as a reference source concerning questions on regulation of radiopharmaceuticals.

Provide reference services for research drugs and radionuclides under research protocols.

Provide instruction (continuing education) to technologists on new changes in radiopharmaceutical products and availability.

Quality Assurance Surveillance Plan: Contractor will be monitored for performance of services according to the following criteria, with the incentive/disincentive being past performance ratings:

Accuracy of delivered order; all daily deliveries should match order placed.

Timeliness of deliveries; all daily deliveries should arrive according to statements above.

Compliance of shipping containers; all containers will be secured and labeled according to NRC and DOT regulations.

Radiation safety review: package surveys and wipes for removable contamination will meet NRC and DOT guidelines.

Communication of industry issues; industry shortages or product recalls will be communicated with twenty-four (24) hours.