Combined Synopsis Radiopharm.pdf

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, “Streamlined Procedures for Evaluation and Solicitation for Commercial Items,” as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a written solicitation document will not be issued.

This solicitation is issued as an RFQ. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2022-06 dated April 26, 2022. This solicitation is unrestricted.

The associated North American Industrial Classification System (NAICS) code for this procurement is 325412 Pharmaceutical Preparation Manufacturing, size standard 750 Employees. Note, interested Service Disabled/Veteran Owned Small Business (SDVOSB/VOSB) Offerors must be listed and registered in Vetbiz.gov to be considered for award. The FSC/PSC is 6505 Drugs and Pharmaceutical Products.

The West Palm Beach VA Medical Center has a requirement for a VISN 8 Radiopharmaceuticals Type of contract.

The contract will be a firm fixed price contract, estimated quantities Indefinite Delivery Quantity (IDC) contract.

Delivery shall be provided no later than 60 days after receipt of order (ARO). Delivery shall be FOB Destination.

Place of Performance/Place of Delivery

Address: West Palm Beach VA Medical Center 7305 North Military Trail West Palm Beach, FL Postal Code: 33410-6400 Country: UNITED STATES

The full text of FAR provisions or clauses may be accessed electronically at:

http://acquisition.gov/comp/far/index.html.

The following Provisions apply towards this Solicitation Acquisition:

1. 52.209-5 Representation by Corporations Regarding an Unpaid Tax Liability or a Felony conviction under any Federal law (Deviation)(MAR 2012)

2. 52.209-7 Information Regarding Responsibility matters (July 2013)

3. VAAR 852.211-73 Brand Name or Equal (JAN 2008)

4. 52.211-6 Brand Name or Equal (AUG 1999)

5. 52.247-8 Estimated Weights or Quantities not Guaranteed (APR 1984)

6. 52.212-1 Instructions to Offers-Commercial Items (OCT 2015)

7. 52.212-2 Evaluation- Commercial Items (OCT 2014)

8. 52.212-3 Offer Representations and Certifications-Commercial Items (APR 2016)

9. 52.217-5 Evaluation of Options (JUL 1990)

10. 52.216-1 Type of Contract

11. 52.233-2 Service of Protest

12. VAAR 852.233-70 Protest Content/Alternative Dispute Resolution (JAN 2008)

13. VAAR 852.233-71 Alternative Protest Procedure (JAN 1998)

14. VAAR 852.211-72 Technical Industry Standards http://acquisition.gov/comp/far/index.html

15. VAAR 852.270-1 Representative of Contracting Officers

16. VAAR 852.273-74 Award Without Exchanges (JAN 2003)

17. 52.252-1 Solicitation Provisions Incorporated by Reference (FEB 1998)

18. 52.216-27 Single or Multiple Awards (OCT 1995)

Offerors must complete annual representations and certifications electronically via the System for Award Management (SAM) website located at https://www.sam.gov/portal in accordance with FAR 52.212-3, “Offerors Representations and Certifications–Commercial Items.” If paragraph (j) of the provision is applicable, a written submission is required.

The following Contract Clauses apply towards this Solicitation Acquisition:

19. FAR 52.212-4 Contract Terms and Conditions-Commercial Items (MAY 2015)

20. FAR 52.212-5 Contracting Terms and Conditions Required to Implement Statutes or Executive Orders-

Commercial Items (JUN 2016)

21. FAR 52.216-18 Ordering (OCT 1995)

22. FAR 52.216-19 Order Limitations (OCT 1995)

23. FAR 52.216-22 Indefinite Quantity (OCT 1995)

24. 52.217-8 Option to Extend Services (NOV 1999)

25. 52.217-9 Option to Extend the Term of the Contract (MAR 2000)

26. 52.225-18 Place of Manufacture (MAR 2015)

27. VAAR 852.203-70 Commercial Advertising (JAN 2008)

28. VAAR 852.203-71 Display of Department of Veterans Affairs Hotline Poster (DEC 1992)

29. VAAR 852.232-72 Electronic Submission of Payment Requests (NOV 2012)

30. VAAR 852.237-70 Contractor Responsibilities (APR 1984)

31. VAAR 852.246-70 Guarantee (JAN 2008)

32. VAAR 852.246-71 INSPECTION (JAN 2008)

33. 52.252-2 Clauses Incorporated by Reference (FEB 1998)

Only new equipment is acceptable; no remanufactured, used/refurbished or "gray market" items. No product in development shall be considered. All items must be covered by the manufacturer's warranty.

All quoters shall submit the following:

• The name, address, and telephone number of the vendor.

• Tax Identification Number (TIN)

• SAM UEI Number / DUNS Number / Cage Code

• Point of Contact for submission of orders if awarded a contract

• Quoted price shall include delivery.

All quotes shall be sent to the following email address: Malcolm.davis@va.gov Award will be based upon a comparative evaluation of quotes in accordance with the Simplified Acquisition Procedures of FAR 13. Comparative evaluation is the side by side pairwise comparison of quotes based on factors resulting in a Contracting Officer decision for the quote most favorable to the Government.

https://www.sam.gov/portal mailto:Malcolm.davis@va.gov

The following are the decision factors:

Offeror quotations must demonstrate meeting the salient physical, functional, or performance characteristic specified in this solicitation, otherwise it will be considered non-responsive. The information identified and provided is intended to be descriptive, not restrictive and to indicate the quality that will be satisfactory. The interested parties bear full responsibility to ensure their submission demonstrates to the government that they can provide the supplies being requested.

The award will be made to the response most advantageous to the Government.

Responses should contain your best terms, conditions.

ADDENDUM to 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL ITEMS

The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers:

Technical Past Performance

Price

Technical and past performances, when combined, are more important than price. The Government anticipates awarding one contract with one vendor per site. The VA will not split line items. The Government anticipates multiple awards for VISN 8 with no more than one vendor per site. However, the Government may elect to make a single award.

VISN 8 Radiopharmaceutical Evaluation Criteria

Factor I – TECHNICAL / MANAGEMENT APPROACH

Sub Factor 1 - Management Plan:

Contractors shall outline and describe their technical plan to provide the services outlined in the PWS, ensuring delivery within required response times after receipt of phoned or faxed orders from the VAMC. Proposals shall describe the management and staffing plans demonstrating and describing the offeror’s ability and approach for providing the resources necessary to maintain service quality levels, staffing levels, training, and risk management.

Sub Factor 2 - Regulatory Compliance:

The Contractor shall provide evidence of current license with the Nuclear Regulatory Commission, Department of Transportation, Food and Drug Administration (FDA) approved radiopharmaceuticals and drugs, Department of Energy (DOE), Occupational Safety and Health Administration (OSHA) and all other Federal and State agency rules and regulations. This requires any contractor submitting an offer related to the associated solicitation possesses/holds and maintains current/active licensure as a Nuclear Pharmacy in the state of Florida, Puerto Rico and Georgia. This also confirms the offeror’s ability to manufacture and deliver approved radiopharmaceuticals as stated in the PWS. This license must be in the name of the contractor submitting the offer in response to the solicitation.

The Offerors shall also submit verification of supply letter(s) from qualified drug manufacturer(s) to ensure the proposed product is an FDA approved product. The VAMC’s will not accept generic compounds that are not FDA approved. Contractors shall also provide descriptive literature on the products being proposed, as listed on the price schedule, in order to answer any and all possible product substitution concerns and shall guarantee the quality of all radiopharmaceuticals offered. A copy of the offeror’s current Radioactive Material License should be included with this information.

Sub Factor 3 - Quality Control Plan:

Contractors shall describe their techniques for maintaining quality control for their products. The proposal shall describe the Offeror's approach for instituting and maintaining a capability to ensure the quality and integrity of services/products, discussing at minimum:

1. management and task controls to assure work will be completed as required

2. contingency plans for identifying and correcting problems,

3. contingency plans to supply radiopharmaceuticals in case of malfunction of equipment or issues in quality testing of their radiopharmaceuticals and

4. steps that will be taken to assure timely delivery of quality products.

The government will consider the completeness of the contractor’s information, their understanding of the requirement, the contractor’s assessment of the objectives to be accomplished and methodology for accomplishing the requirement and determine the appropriate rating.

Factor II Past Performance

In accordance with FAR 15.305, the contractors shall provide three references of their relevant and recent performance providing radiopharmaceutical manufacturing products and services within the last three years having roughly the same magnitude and complexity as this requirement using the attached past performance questionnaire. The Government may use Past Performance Information Retrieval System (PPIRS). All data in PPIRS is classified as Source Selection Sensitive.

Factor III Price

The VA promotes preferential procurement of non-High Enriched Uranium (HEU) Derived Medical Isotopes as they become more commercially available.

In that regard, our requirement is that contractors provide pricing for non-HEU High Enriched Uranium- Derived medical isotopes, as well as HEU High Enriched Uranium-Derived medical isotopes for the CLINS listed in the price schedule, this option will offer the customer some degree of discretionary ordering options based on need, availability, and price. The acceptable VA non-HEU standard of purity is 95% or better.

Price will be evaluated based on the Best Value to the Government. A tradeoff process requirement is that the best interest of the Government to consider an award to other than the lowest priced offeror or other than the highest technically rated offeror.

EVALUATION METHODOLOGY- The following adjectival rating system will be used to determine the overall technical rating of each Contractors proposal:

OUTSTANDING SATISFACTORY U NSATISFACTORY

Proposal meets requirements Proposal meets requirements Proposal does not meet and indicates an exceptional and indicates an adequate requirements and contains approach and understanding of approach and understanding one or more major the requirements. The of the requirements. deficiencies. Proposal is un-proposal contains multiple Proposal has minor strengths awardable.

strengths and no deficiencies. and /one or more

Risk of unsuccessful deficiencies. Risk of performance is very low. unsuccessful performance is no worse than moderate.

Technical / Management Approach: Will be evaluated by the technical team on knowledge of radiopharmaceuticals to determine if the Offeror is a viable competitor for the resultant acquisition.

Past Performance: Will be evaluated by the Contracting Officer on the quality of the contractors past performance within the last three years with respect to contracts of similar size, complexity and scope. This includes, but is not limited to, timeliness of contract completion, including adherence to contract schedules and timely submission of data deliverables; the contractors ability to comply with the terms and conditions of the contract; the overall quality of the work performed on the contract; the Contractors managerial performance’ and whether or not the reference would enter into a contract with the contractor again. Contractors without relevant past performance or for whom past performance information is not available, will receive a neutral rating.

Past Performance Rating System

Outstanding Satisfactory Neutral Unsatisfactory

Overall performance exceeds contractual requirements and gives extra benefits to the customer. Problems, if any, were promptly corrected without negative impact to the customer.

Performance meets contractual requirements.

Performance contains some minor problems for which corrective actions taken by the contractor appear to be or were satisfactory.

No recent/relevant performance record is available or the offeror’s performance record.

Performance does not meet most contractual requirements.

Performance contains serious problem(s) for which the contractor’s corrective actions were or appeared ineffective if implemented at all.

Price: Will not be scored but evaluated against the other non-price factors to determine the offer that is the overall best value to the Government. Price will be analyzed for fairness and reasonableness. Options will also be evaluated and analyzed for price fairness and reasonableness.

FAR 15.101-1 Tradeoff Process

a. A tradeoff process is appropriate when it may be in the best interest of the

Government to consider award to other than the lowest priced offeror or other than the highest technically rated offeror.

b. Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s).

c. A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party.

Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

(End of Provision)

Submission of your response shall be received not later than 11/16/2022 by 12:00 PM (EST) by email at Malcolm.davis@va.gov. Offers received after the time specified in the solicitation are considered late and may be considered, if the action would not unduly delay the acquisition or are deemed to be in the best interest of the government, late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f).

Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail to the Point of Contact No Later Than (NLT) 11/14/2022 by 12:00 PM (EST).

Point of Contact

Contracting Specialist Malcolm Davis Malcolm.davis@va.gov