36C24624Q0015.docx

Sources Sought Notice

Radiopharmaceuticals and Associated Supplies Brand Name or Equal

GENERAL INFORMATION

SET-ASIDE

CONTRACTING OFFICE ADDRESS

Department of Veterans Affairs Network Contracting Office 6 100 Emancipation Drive Hampton VA 23667

POINT OF CONTACT*

Contracting Officer James Risbon james.risbon@va.gov

PLACE OF PERFORMANCE

1100 Tunnel Road

Asheville NC

COUNTRY

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

RFI 36C24624Q0015

Sources Sought Notice

DISCLAIMER

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

This RFI is issued solely for information and planning purposes and does not constitute a Solicitation, an Invitation for Bids, a Request for Proposal (RFP), a Request for Quotation (RFQ), or an indication the Government will contract for the items contained in this announcement. All information received in response to this RFI marked “Proprietary” will be handled accordingly. Responses to the RFI will not be returned. In accordance with FAR 15.201(e), responses to this RFI are not offers and cannot be accepted by the Government to form a binding contract.

PURPOSE

The purpose of this RFI 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.

INTRODUCTION

The Asheville VAMC has a requirement for a Base plus 3 Option Years for nuclear medicine services to be provided for requested radiopharmaceuticals and associated supplies within 90 minutes of receipt of requirement notification to the Charles George, Asheville VA Medical Center, 1100 Tunnel Road, Asheville NC, 28805.

Period of Performance:

Base Year 10-01-2023 to 09-30-2024 Option Year #1 10-01-2024 to 09-30-2025 Option Year #2 10-01-2025 to 09-30-2026 Option Year #3 10-01-2026 to 09-30-2027

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 Charles George, Asheville VA Medical Center, 1100 Tunnel Road, Asheville, NC 28805:

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 1:00 pm EDT Friday, September 22, 2023. All interested parties should respond, in writing via email to james.risbonva.gov. No telephone inquiries will be accepted. Respondents to this RFI 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 1:00 pm (Eastern Time) 09/22/2023. Please include RFI # 36C24624Q00151 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

The contractor will be required to provide radiopharmaceuticals and associated supplies to the Charles George Veterans Affairs Medical Center, Asheville, NC, Monday through Friday as needed, excluding Federal holidays. Continuation of nuclear medicine services without delay in patient care or treatment at this facility requires all vendors and vendor personnel to be established, equipped, competent, and active in all items listed below. Items will include but not be limited to the following:

1. Quantities expressed in the price/cost schedule are estimates based on historical usage for one year. However, quantities may vary based on patient demand.

2. Vendor shall respond within 15 minutes of original notification and prepare and deliver radiopharmaceuticals within 90 minutes of original notification.

3. All vendor personnel preparing radiopharmaceuticals are required to be board certified in nuclear pharmacy or listed as an authorized user on the radioactive materials license. Reference: Title 10 Code of Federal Regulations (10 CFR) Part 35.55 and 35.57.

4. In accordance with the VA Memorandum, dated January 3, 2014, and signed by Under Secretary for Health, the Department of Veterans Affairs (VA) will preferentially procure medical radioisotopes from non-High Enriched Uranium (LEU) sources. The contractor for the VA radiopharmaceuticals must be able to produce medical grade radioisotopes from preferentially procured non-Highly Enriched Uranium – 235 (LEU) sources. A request has been made to VHA by the Interagency Policy Committee of the White House to preferentially procure Technetium-99m (Tc-99m), the primary radioisotope used in medical diagnosis, produced from non-HEU sources. The reason for this request is that transportation and storage of HEU by radioisotope vendors may be a security and nuclear proliferation risk. Also, the enactment in January 2013 of the American Medical Isotopes Production Act of 2011 supports creation of domestic production with the goal of reducing U.S. dependence on foreign sources of medical radioisotopes. This facility elects to purchase unit doses only. Request pricing of unit doses for all items. All Technetium 99m labeled materials require LEU generator of at least 95% non-HEU sourced molybdenum-99 materials at this facility.

5. All prices quoted on the Price/Cost Schedule for each unit item shall include any other charges including, but not limited to, site delivery charges during business hours, emergency or call back charges after hours, etc. Fuel charges and sealed source/meter shipping charges are listed as separate line items. Facility will not accept separate line items for any other charges.

6. This facility is established with and requires the vendor use of an on-site LEU Generator for production of all Technetium 99m labeled materials. Vendor must have active LEU generator on-site at time of solicitation to be deemed qualified. Preference will be given for radioactive materials sources acquired domestically over internationally.

7. Vendor shall prepare and transport kits and doses according to (including all updates to) Manufacturer’s Package Insert instructions, Dept. of Transportation (DOT) requirements, FDA requirements, United States Pharmacopeia including USP 797, USP 825 requirements, NC Pharmacy standards and regulations, Vendor’s radioactive materials license, and applicable Title 10 Code of Federal Regulations requirements to include, but not limited to the instructions below:

a. Vendor shall not prepare kits using over 3 elutions. All individual doses shall be traceable to the original elution if documentation requested by the facility.

b. All Vendor pharmacy quality control records shall be presented to the facility at the time of request for any dose received to include time of QC, time of elution, eluant documentation, time of preparation, and QC breakdown at any point in the material’s shelf life.

c. Vendor shall obtain prior written permission of the Radiation Safety Officer (RSO) or Facility Authorized User (AU) for any substitutions (generic, alternate, non-brand name, different brand name, manufacturer change, etc.) of items on the price list prior to use.

d. Vendor shall compound or prepare following all the above requirements unless prior written permission of the RSO or AU given. Radiochemical purity and radiolabel must meet manufacturer’s package insert requirements and records kept available upon request.

e. Any dose deemed below standard by the facility shall be credited toward the account (e.g., unacceptable thyroid, stomach, kidney, or tissue uptake) as determined by the RSO or AU.

f. Vendor will utilize adequate infection control standards for disinfecting the shielded (lead lined or other) carriers of unit dose syringes (lead pigs, etc.) before and after shipments to maintain As Low as Reasonably Achievable radiation contamination practices as defined in applicable regulations.

g. Vendor will provide credit on any dose not ordered by the facility and Per Physician Order (PPO) doses not used for the following Technetium-99m-labeled radiopharmaceuticals: Tc99m-Pertechnetate, Tc99m-Sestamibi, Tc99m-HDP, Tc99m-Mebrofenin. This facility must decay in storage all unit dose radioactive materials according to its radioactive materials license.

8. Vendor shall provide new package inserts and SDS sheets for each material as they become available and upon request of the facility.

9. This facility utilizes electronic records for radiopharmaceuticals with EC2 software platform. Vendor must utilize compatible software that interfaces and is supported by Biodose / EC2 software including bar codes and bar code scanner operation.

10. Vendor shall provide any additional electronic technical support deemed necessary for the technical staff, physicians, patient education, etc. for the above software.

11. Vendor will provide correct monthly invoices with complete itemized list of all radiopharmaceutical and other items ordered, listed by prescription number, ID used, procedure, date and time, and individual cost per item (including return credits). Invoices shall be submitted to the COR or uploaded to the IPPS website within 10 calendar days from the end of the month. Incorrect items shall be corrected, completed, and resubmitted within 7 calendar days of notification.

12. Vendor will provide quotes as needed for sheet sources, source disposals, meter calibrations, and Radiopharmacy supplies. Survey meters will be calibrated with a standard source that is traceable to the National Institute of Standards and Technology (NIST). Survey meter calibrations will be performed in accordance with ANSI N323, 10 Code of Federal Regulations Subpart C: § 35.61 (a)(1), (2), (3), and (b). and the manufacturer’s recommendations for calibration.

13. Vendor will respond to requests by VA personnel to schedule audits within 72 hours of request being made.

The following table is to be completed by all offerors as part of the quote/offer. Failure to complete, submit, sign, provide indicated documentation and include it with your quote/offer may deem your quote/offer unresponsive.

Technical requirements SOW responses and documentation requirements

Items 1. and 6.

Vendor can supply all the products at the time of solicitation as listed in the Price/Cost Schedule to the Charles George VA Medical Center.

Check one:

|_| Vendor can meet Requirement |_| Vendor cannot meet Requirement Comments/Requested changes:

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Items 1. and 2.

Orders will be placed daily and as needed basis by authorized facility employees. Vendor will respond within 15 minutes of notification and deliver within 90 minutes of notification.

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|_| Vendor can meet Requirement |_| Vendor cannot meet Requirement Comments/Requested changes:

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Item 3.

All vendor personnel preparing radiopharmaceuticals are required to be board certified in nuclear pharmacy or listed as an authorized user on the radioactive materials license.

Submit list of all persons preparing unit doses.

Submit copies of above Pharmacist Nuclear Medicine Board Certifications for all persons preparing unit doses.

Submit copy of vendor’s facility NC Radioactive Materials License and NRC License.

Check one:

|_| Vendor Accepts Requirement |_| Vendor Rejects Requirement Comments/Requested changes:

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Item 4.

Facility elects to purchase unit doses only. Request pricing of unit doses for all items.

All Technetium 99m labeled materials require active and on-site LEU generator production of at least 95% non-HEU sourced molybdenum-99 materials at this facility.

Submit copy of FDA registration for manufacturing Radioactive Materials Check one:

|_| Vendor can meet Requirement |_| Vendor cannot meet Requirement Comments/Requested changes:

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Items 5. and 7.g. and 11.

All prices quoted on the Price/Cost Schedule for each unit item shall include any other charges including, but not limited to, delivery, fuel, emergency charges, etc. Facility will not accept separate line items for the above.

Vendor will provide credit on any doses not ordered and PPO doses unused for the following Technetium-99m-labeled radiopharmaceuticals: Tc99m-Pertechnetate, Tc99m-Sestamibi, Tc99m-HDP, Tc99m-Mebrofenin. This facility must decay in storage all unit dose radioactive materials according to its radioactive materials license.

Vendor will provide monthly invoices with complete itemized list of all radiopharmaceutical and other items ordered, listed by prescription number, ID used, procedure, date and time and individual cost per item (including credits) listed.

Submit a sample invoice including a credited item.

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|_| Vendor Accepts Requirement |_| Vendor Rejects Requirement Comments/Requested changes:

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Item 6.

Vendor is established and active with all pharmacists competent and actively preparing LEU (>95%) materials and other materials at the time of solicitation to be accepted as qualified.

Submit current manufacturer’s LEU Generator Certification for on-site generator.

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|_| Vendor can meet Requirement |_| Vendor cannot meet Requirement Comments/Requested changes:

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Items 7.a. and 7.b.

All doses are prepared using less than three elutions and traceable to the original elution upon facility request.

All Vendor pharmacy quality control records shall be presented to the facility at the time of request for any dose received to include time of QC, time of elution, eluant documentation, time of preparation, and QC breakdown at any point in the material’s shelf life.

Submit a sample QC report with all items above.

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|_| Vendor Accepts Requirement |_| Vendor Rejects Requirement Comments/Requested changes:

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Item 7.c.

Generic equivalents or substitutes are not acceptable without prior written approval from the radiation safety officer.

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Item 7.d.

All doses are prepared in accordance with applicable requirements.

Radiochemical purity and radiolabel must meet manufacturer’s package insert requirements and records kept available upon request.

Submit sample purity and radiolabel acceptance documentation.

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|_| Vendor Accepts Requirement |_| Vendor Rejects Requirement Comments/Requested changes:

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Item 7.e.

Any dose deemed below standard by the radiation safety officer shall be credited for the full amount (e.g., unacceptable thyroid, stomach, kidney, or tissue uptake).

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Item 7.f.

Vendor will utilize adequate infection control standards for disinfecting the lead lined carriers of unit dose syringes (lead pigs) before and after shipments to maintain As Low as Reasonably Achievable radiation contamination practices as defined in applicable regulations.

Describe process to disinfect and control contamination of carriers while maintaining ALARA requirements.

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|_| Vendor Accepts Requirement |_| Vendor Rejects Requirement Comments/Requested changes:

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Item 8.

Vendor shall provide new package inserts and MSDS sheets for each material as they become available.

Submit a current sample package insert and SDS.

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|_| Vendor Accepts Requirement |_| Vendor Rejects Requirement Comments/Requested changes:

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Items 9. And 10.

This facility utilizes electronic records for radiopharmaceuticals with EC2 software platform. Vendor must utilize compatible software that interfaces and is supported by Biodose / EC2 software including bar codes and bar code scanner operation.

Vendor shall provide any additional technical support deemed necessary for the technical staff, physicians, patient education, etc.

Submit sample bar coded dose label that is compatible.

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|_| Vendor Accepts Requirement |_| Vendor Rejects Requirement Comments/Requested changes:

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Item 12.

Vendor will provide quotes as needed for sheet sources, source disposals, survey meter calibrations, and Radiopharmacy supplies.

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|_| Vendor Accepts Requirement |_| Vendor Rejects Requirement Comments/Requested changes:

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Item 13.

Vendor will respond to requests by VA personnel to schedule audits within 72 hours of request being made.

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|_| Vendor Accepts Requirement |_| Vendor Rejects Requirement Comments/Requested changes:

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I certify that the responses and information provided by me in Table 1 are accurate and complete to the best of my knowledge and belief.

Signature Date

Printed Name

Company Name

Sources Sought Notice

Sources Sought Notice