Inactive Total Small Business Set-Aside (FAR 19.5)

This is a request for quote (RFQ), and the solicitation number is 36C25024Q0663. The Government anticipates awarding a firm-fixed price Purchase Order resulting from this solicitation. The solicitat... This is a request for quote (RFQ), and the solicitation number is 36C25024Q0663. The Government anticipates awarding a firm-fixed price Purchase Order resulting from this solicitation. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circulars FAC 2024-03 (eff. 2/23/2024). The associated NAICS Code is 325412, Pharmaceutical Preparation Manufacturing.  The Department of Veterans Affairs, Network Contracting Office 10, is soliciting quotes from all sources to supply the Dayton VA Medical Center PYLARIFY F-18 piflufolastat radiopharmaceutical doses for the imaging of patients with prostate cancer. Respondents to this solicitation must fully demonstrate their capability by supplying detailed quote information, along with any other documents necessary to support the requirements below. However, we believe only the authorized distributors of Progenics Pharmaceuticals, Inc., a Lantheus company can supply this requirement. We believe only Sofie Co., and PharmaLogic Cincinnati are the only Contractors able to provide this requirement for the Dayton VA Medical Center.  Quotes are to be provided to Gina P. Crank, Contracting Officer, via email at gina.crank@va.gov, no later than June 12,  2024, by 5:00 PM EST. No telephone calls will be accepted. No submission received after the above-mentioned date and time will be accepted.  Statement of Work Radiopharmaceutical Supply and Delivery for Dayton VA Medical Center Contractor shall furnish the following services for the administration of radiopharmaceuticals at the Dayton VA Medical Center: Contractor shall provide routine delivery of items during the hours of 7:00 am to 4:30 pm, Monday through Friday, excluding holidays. Delivery of all radiopharmaceuticals will be made to the Dayton VA Medical Center, nuclear Medicine Service, 4100 W Third Street Dayton, OH 45428, Bldg. 330, Room 1C-129, during normal business hours (Monday through Friday excluding Federal Holidays 7:00 to 4:30 pm). During non-business hours, deliveries are to be made through VA Police Service, and the driver will be escorted to Nuclear Medicine Service. All routine deliveries of radiopharmaceuticals shall be delivered one hour before calibration time. All routine deliveries of radiopharmaceuticals, ordered by 4:30 pm the previous day, shall be at the VA facility by 7:00 am the next business day. No deliveries of unit doses except by the courier of the supplier. All couriers must wear a picture ID that is clearly visible while making deliveries of radiopharmaceuticals. All doses shall be labeled with prescription number, radiopharmaceutical name and amount in the syringe. All therapy doses will also include the patient s name. A packing slip must accompany all doses. A sticker with all radiopharmaceutical information must be attached to each dose; stickers will be used for the Nuclear Medicine dose logs. Contractor shall replace any items delivered in error at no cost to the Dayton VA Medical Center. Contractor shall meet all NRC, DOT, FDA and all other agency rules and regulations (Federal and State). Contractor shall perform all quality control procedures as required by Federal and State regulatory agencies. No additional fees or charges are authorized for routine deliveries. Radiopharmaceuticals that will/could be ordered from the vendor: F-18 PYLARIFY (piflufolastat) The 11 Federal Holidays observed by the Federal Government are: New Year s Day January 1 Martin Luther King s Birthday 3rd Monday in January Presidents Day 3rd Monday in February Memorial Day Last Monday in May Juneteenth Day June 19 Independence Day July 4 Labor Day 1st Monday in September Columbus Day 2nd Monday in October Veterans Day November 11 Thanksgiving Day 4th Thursday in November Christmas Day December 25th The President of the United States of America may declare additional days as a Federal holiday, and if so, this holiday will automatically be added to the list above. When a holiday falls on a Sunday, the following Monday shall be observed as a Federal holiday. When a holiday falls on a Saturday, the preceding Friday shall be observed as a Federal Holiday. ITEM INFORMATION ITEM NUMBER DESCRIPTION OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT 0001 200.00 EA F18-Pylarify-A9595 Unit Dose 552-24-3-778-0051 GRAND TOTAL The following solicitation provisions apply to this acquisition: FAR 52.212-1, INSTRUCTIONS TO OFFERORS COMMERCIAL ITEMS (JUNE 2020) FAR 52.212-3, OFFERORS REPRESENTATIONS AND CERTIFICATIONS COMMERCIAL ITEMS (FEB 2021) 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 to this acquisition: FAR 52.212-4, CONTRACT TERMS AND CONDITIONS COMMERCIAL ITEMS (OCT 2018) ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS COMMERCIAL ITEMS Clauses that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The following clauses are incorporated into 52.212-4 as an addendum to this contract: FAR 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998) FAR 52.203-16 PREVENTING PERSONAL CONFLICTS OF INTEREST (DEC 2011) FAR 52.203-17 CONTRACTOR EMPLOYEE WHISTLEBLOWER RIGHTS AND REQUIREMENT TO INFORM EMPLOYEES OF WHISTLEBLOWER RIGHTS (APR 2014)FAR 52.204-4 PRINTED OR COPIED DOUBLE-SIDED ON POSTCONSUMER FIBER CONTENT PAPER (MAY 2011)FAR 52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE MAINTENANCE (JUL 2016) FAR 52.232-40 PROVIDING ACCELERATED PAYMENTS TO SMALL BUSINESS SUBCONTRACTORS (DEC 2013) VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA ACQUISITION OF COMMERCIAL ITEMS (APR 2020) 852.203-70, 852.232-72, 852,233-70, 852.233-71 852.246-71, 852.247-71, 852.270-1 VAAR 852.212-71 GRAY MARKET LANGUAGE (MAY 2016) FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders Jan 2021 The following subparagraphs of FAR 52.212-5 are applicable: [52.203-6, 52.204-10, 52.209-6, 52.219-6, 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-35, 52.222-36, 52.222-37, 52.222-40, 52.222-50, 52.223-18, 52.225-1, 52.225-13, 52.232-18, 52.232-19, and 52.232-33.] FAR 52.232-2 SERVICE OF PROTEST (SEPT 2006) - - Hand-Carried Address: Department of Veterans Affairs, Network Contracting Office 10, 2780 Airport Drive, Suite 340, Columbus, OH 43219 All quoters shall submit the following: A completed schedule with pricing, adequate documentation detailing the capabilities of the product. All quotes shall be sent to the electronically via email to Gina P. Crank - gina.crank@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. The award will be made to the response most advantageous to the Government. Responses should contain your best terms, conditions. To facilitate the award process, all quotes must include a statement regarding the terms and conditions herein as follows: "The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition." OR "The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:" Quoters shall list exception(s) and rationale for the exception(s), if any. Submission of your response shall be received not later than June 12, 2024 @ 5:00 PM Eastern Time to gina.crank@va.gov 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 listed below. Point of Contact Gina P. Crank Contracting Officer Network Contract Office (NCO) 10 Office: 614-625-1236 Email: gina.crank@va.gov DEPARTMENT OF VETERANS AFFAIRS Justification and Approval (J&A) For Other Than Full and Open Competition (>SAT) Acquisition Plan Action ID: 36C250-24-AP-3700 Contracting Activity: Department of Veterans Affairs, Network/Program Contracting Office 10, located at 2780 Airport Drive, Columbus OH 43219, in support of VISN 10 VA Health Care System at 4100 W. Third Street, Dayton, OH 45428 using purchase request # 552-24-3-778-0051. Nature and/or Description of the Action Being Processed: This request is for PYLARIFY F-18 piflufolastat radiopharmaceutical doses for the imaging of patients with prostate cancer. This will be awarded as a new firm fixed price Contract. Description of Supplies/Services Required to Meet the Agency s Needs: This request is for PYLARIFY F-18 piflufolastat radiopharmaceutical doses for the imaging of patients with prostate cancer. To be delivered on an as needed basis for patient studies throughout the contract. Request is to purchase 200 doses to be used for a time span of 12 months, estimated Period of Performance 06/17/2024 06/16/2025. Statutory Authority Permitting Other than Full and Open Competition: (X) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per 41 USC §3304(a)(1) as implemented by FAR 6.302-1; ( ) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by FAR 6.302-2; ( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by FAR 6.302-3; ( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by FAR 6.302-4 ( ) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by FAR 6.302-5; ( ) (6) National Security per 41 USC §3304(a)(6) as implemented by FAR 6.302-6; ( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by FAR 6.302-7; Demonstration that the Contractor s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): PYLARIFY® (piflufolastat F 18) Injection ( PYLARIFY ) is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer. It can be used for men with suspected metastasis who are candidates for initial definitive therapy or those with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. On May 26, 2021, Progenics Pharmaceuticals, Inc., a Lantheus company (the Company ) received FDA approval of PYLARIFY. Please be advised that the Company is the sole manufacturer of PYLARIFY. There is no other like item(s) or product(s) available for purchase that would serve the same purpose or function and there is only one price for the above name(s) item(s) or product(s) because of exclusive distribution or marketing rights. However, Progenics Pharmaceuticals, Inc., a Lantheus company (the Company ) has two authorized distributors of their PYLARIFY. Sofie Co., and PharmaLogic Cincinnati. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: VetCert was searched using NAICS 325412 which netted 128 Vendors. DSBS netted 1,342, added keyword Pylarify netted 0. Search on the Open Market resulted 0 Vendors. The OEM, Progenics Pharmaceuticals, Inc., a Lantheus company (the Company ), has 2 authorized distributor for this requirement, Sofie Co, a SB and a PharmaLogic Cincinnati a SB, they both provide FSS pricing for this Radiopharmaceutical. The VA Rule of Two was Unattainable, however the SBA Rule of Two is Attainable. This requirement will be posted on Contracting Opportunities as a SB Set-aside and competed amongst the OEM s authorized SB Distributors. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The Dayton VA Medical Center has been offering this PROSTATE CANCER scan for several years and has become increasingly popular due to our patient population. If the VA dose not continue to purchase this radiopharmaceutical, we would be forced to send these patient out to the community to be scanner at 3 times the cost of doing them in house. As mentioned above both Vendors will provide FSS pricing for this Radiopharmaceutical. FSS pricing is already determined F&R. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: As mentioned above Market Research was conducted by way of VetCert, DSBS, and on the Open Market. Progenics Pharmaceuticals, Inc., a Lantheus company received FDA approval of PYLARIFY and is the sole manufacturer of PYLARIFY yet offers two SB authorized distributors, Sofie Co. and PharmaLogic Cincinnati. Any Other Facts Supporting the Use of Other than Full and Open Competition: NA Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Sofie Co. and PharmaLogic Cincinnati. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required: Contracting will continue to survey this requirement for additional available vendors. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief. _____________________________ Jeff Willsey, BS, CNMT Nuclear Medicine Service Director/Supervisor Dayton VA Medical Center Approvals in accordance with the VHAPM Part 806.3 OFOC SOP: Contracting Officer Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. _____________________________ Gina P. Crank Contracting Officer NCO 10 Columbus One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition. _____________________________ Adam P. Weber Branch Chief SUPPLY TEAM #1 (OHIO) NCO 10 Dayton