Loren Data's SAM Daily™

SAMDAILY.US - ISSUE OF OCTOBER 20, 2022 SAM #7629
SOLICITATION NOTICE

65 -- TheraSphere Y 90 Nuclear Med CLE

Notice Date

10/18/2022 12:28:18 PM
 

Notice Type

Combined Synopsis/Solicitation
 

NAICS

325412 — Pharmaceutical Preparation Manufacturing
 

Contracting Office

250-NETWORK CONTRACT OFFICE 10 (36C250) DAYTON OH 45428 USA
 

ZIP Code

45428
 

Solicitation Number

36C25023Q0055
 

Response Due

10/21/2022 1:00:00 PM
 

Archive Date

01/19/2023
 

Point of Contact

Gina P. Crank, Contracting Officer, Phone: 614.625.1236, Fax: NA
 

E-Mail Address

gina.crank@va.gov
(gina.crank@va.gov)
 

Awardee

null
 

Description

This is a combined synopsis/solicitation for commercial items prepared in accordance with (IAW) the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. The Government reserves the right to make no award from this solicitation.     This is a request for quote (RFQ), and the solicitation number is 36C25023Q0055. 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 2022-08, effective 09/23/2022. 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 Cleveland VA Medical Center TheraSphere®, Y-90 Glass Microsphere for patient care which is a therapeutic agent used to treat unresectable primary Hepatocellular Carcinoma. 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 TheraSphere®, Y-90 Glass Microsphere is only manufactured, sold and distributed exclusively by Boston Scientific .   Quotes are to be provided to Gina P. Crank, Contracting Officer, via email at gina.crank@va.gov, no later than October 21,  2022, by 4:00 PM EST. No telephone calls will be accepted. No submission received after the above-mentioned date and time will be accepted.    Statement of Work (SOW): The VA Medical Center (VAMC), Cleveland OH has a requirement for TheraSphere®, Y-90 Glass Microsphere. The Contractor is to provide 20 doses on an as needed basis. DELIVERIES: Deliveries shall be made to: Cleveland Louis Stoke VAMC Wade Park Campus Nuclear Medicine Service, Room BC446 10701 East Blvd Cleveland, OH, 44106 1. Contract Title. TheraSphere®, Y-90 glass microsphere 2. Background. TheraSphere®, Y-90 glass microsphere is a therapeutic agent used to treat unresectable primary Hepatocellular Carcinoma. It consists of microscopic glass spheres that are attached to a radioactive isotope (Y-90) and then injected into the patient. The spheres are trapped in the liver where they can treat liver cancer. 3. Scope. We are requesting to purchase twenty (20) doses of TheraSphere®, Y-90 glass microspheres to treat an estimated twenty (20) patients for Hepatocellular Carcinoma. If more doses are needed for additional patients, we will request an amendment to this purchase order or submit a new contract request (2237 and associated paperwork). 4. Specific Tasks. The government requires deliver to be made according to the schedule for quantities as ordered. Contractor shall provide deliveries as determined by the government. Contractor shall replace any items delivered in error at no cost to the medical center. Contractor shall label all products as to the amount of radiopharmaceutical, preparation time, expiration time and date; and to comply with the specific facility requirements. The Contractor shall provide the TheraSphere administration set and the TheraSphere administration accessory kit at no additional cost to the Medical Center. Contractor shall meet all Nuclear Regulatory Commission, Department of Transportation and F.D.A., 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. Items shall be adequately packaged to prevent damage during handling and storage. All packaging of radioactive material SHALL BE clearly labeled RADIOACTIVE on the outside of the carton it is shipped in. Contractor shall invoice at least once a month to the Nuclear Medicine Service, showing the period covered, billing date, name of preparation, quantity, and amount. Contractor shall provide a copy of their laboratory s current quality control manual and shall be willing to discuss and discrepancies in lab results, which do not fit the clinical picture. Contractor shall test the product for Quality Control and only those products that pass quality control may be sent to the VA. The testing shall be performed at no cost to the VA. The contractor will provide a detailed description of the test upon request. Contractor shall assign to this medical center an individual sales representative to aid in facilitation in the smooth coordination between the medical center and nuclear pharmacy. Contractor shall provide a credit of 100% of the purchase price for unused doses for the following reasons: Patient health, patient death, blood work results out of range, scheduling delays due to weather, traffic or transportation difficulty or other considerations at the contractor s discretion. Credits shall be provided by credit memo. Contractor shall provide current material safety data sheets in a binder and updates as necessary on all delivered products for the medical center. Contractor shall not 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 shall be received within 72 hours of notification by the VA. Contractor shall be licensed by the Nuclear Regulatory Commission and be regularly established in the business of providing radionuclides. Offeror shall provide copies of licenses and certifications along with proposal to the Contracting Officer. 4.1 Task 1 - Enterprise Management Controls. 4.1.1 Subtask 1 - Integration Management Control Planning. Provide the technical and functional activities at the required level for integration of all tasks specified within this SOW. Include productivity and management methods such as quality assurance, progress/status reporting and program reviews. Provide the centralized administrative, clerical, documentation and related functions. 4.1.2 Subtask 2 - Contract Management. Prepare a Contract Management Plan describing the technical approach, organizational resources and management controls to be employed to meet the cost, performance and schedule requirements throughout Contract execution. Provide a monthly status report monitoring the quality assurance, progress/status reporting and program reviews applied to this contract. Contractor shall test all products for Quality Control and only those products that pass quality control may be sent to the VA. The testing shall be performed at no cost to the VA. The contractor will provide a detailed description of the test upon request. Each TheraSphere®, Y-90 glass microsphere dose will be inspected and measured in a dose calibrator to ensure that the correct dosage is in a properly labeled syringe/vial. Any unlabeled or mislabeled syringes/vials will be subject to immediate action by nuclear medicine. Replacement doses will be sent at no cost to the VAMC. The parties representatives will meet periodically as agreed to review the TheraSphere®, Y-90 glass microsphere doses and to address any requests or issues as may have arisen in the period prior to review. Meetings can be held over the telephone or face to face. Either party may call a meeting upon not less than three (3) days notice if that party reasonably considers that there are issues which need to be discussed and/or resolved relating to the therapeutic doses. Both parties will make reasonable efforts to attend meetings called on shorter notice when required. Any meeting may be carried out by teleconference or videoconference. Deliverables: TheraSphere®, Y-90 glass microsphere Therapeutic doses Deliverables: 5. Performance Monitoring See subtask 4.1.2 6. Security Requirements Vendor will not be required to connect equipment on the existing VA network. 7. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI). Not Applicable. 8. Other Pertinent Information or Special Considerations. None a. Identification of Possible Follow-on Work. None b. Identification of Potential Conflicts of Interest (COI). None c. Identification of Non-Disclosure Requirements. None d. Packaging, Packing and Shipping Instructions. All TheraSphere®, Y-90 glass microsphere doses shall be delivered to Nuclear Medicine Service Room BC446 at the Louis Stokes Cleveland VA Medical Center. All doses shall be labeled correctly by DOT standards for radioactive shipments. All shipments will be sealed from tampering, intact and free from removable contamination. e. Inspection and Acceptance Criteria. Each shipment received daily will be visually inspected for any possible damage and to ensure package is free from tampering. Each shipment will be tested for radioactive levels and for removable radioactive material. Any deviations from the instructions in d. above will be brought to the immediate attention of the Contractor for action. 9. Risk Control There are not any risk areas for this contract. 10. Place of Performance. The TheraSphere®, Y-90 glass microsphere therapeutic doses shall be delivered to Nuclear Medicine Service, Room BC446 at the Louis Stokes Cleveland VAMC, 10701 East Boulevard, Cleveland, Ohio 44106. 11. Period of Performance. This is for a purchase order to cover the period from, October 31, 2022 to December 31, 2022. 12. Delivery Schedule. Describe the items to be delivered throughout the period of performance and at completion of the contract, if applicable. The delivery schedule format is as follows: SOW Task# Deliverable Title Format Number Calendar Days After CO Start Tasks 1-20 Delivery of TheraSphere®, Y-90 glass microsphere therapeutic doses As needed- to be ordered by the government based on patient care needs. * Standard Distribution: 1 copy of the transmittal letter without the deliverable to the Contracting Officer shall be Emailed. 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 20.00 EA $ $ TheraSphere, Y-90 glass microsphere is a therapeutic agent used to treat unresectable primary Hepatocellular Carcinoma. It consists of microscopic glass spheres that are attached to a radioactive isotope (Y-90) and then injected into the patient. The spheres are trapped in the liver where they can treat liver cancer. Funding/Req. Number: 1 541-23-1-778-0009 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 October 21,  2022, by 4:00 PM EST 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: 36C250-22-AP-5806 Contracting Activity: Department of Veterans Affairs, VISN 10, Louis Stokes Cleveland VA Medical Center, 10701 East Blvd., Cleveland, OH 44106. Contracting agency responsible for this contracting action is NCO 10 Columbus, 2780 Airport Drive, Suite 340, Columbus, OH 43219 using transaction # 541-23-1-778-0009. Nature and/or Description of the Action Being Processed: TheraSphere®, Y-90 glass microsphere is a therapeutic agent used to treat unresectable primary Hepatocellular Carcinoma. It consists of microscopic glass spheres that are attached to a radioactive isotope (Y-90) and then injected into the patient. The spheres are trapped in the liver where they can treat liver cancer. This will be awarded as a new Firm Fixed Price Purchase Order. Description of Supplies/Services Required to Meet the Agency s Needs: As mentioned TheraSphere®, Y-90 glass microsphere is a therapeutic agent used to treat unresectable primary Hepatocellular Carcinoma. We are requesting to purchase twenty (20) doses of TheraSphere®, Y-90 glass microspheres to treat an estimated twenty (20) patients for Hepatocellular Carcinoma. This will be ordered on an as needed basis starting October 31, 2022 December 31, 2022. 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): TheraSphere® Yttrium-90 (Y-90) Glass Microspheres are manufactured, sold, and distributed exclusively by Biocompatibles, an affiliate of Boston Scientific. TheraSphere® Y-90 glass microspheres are FDA-approved (PMA #P200029). Boston Scientific, is considered a sole source provider for TheraSphere, and the product is shipped directly from BWXT Medical Ltd. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Per FAR 5.102 and 6.305 this Justification and a Combined Synopsis will be posted on SAM Contract Opportunities (FBO) since being a Brand Name Acquisition exceeding $25K. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The pricing is in line with the IGCE as well as the in line with 36C250-21-P1236, Purchase Order # 541-A10163. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: VIP, GSA, NAC and the internet were searched. VIP with NAICS 325412 resulted 91 SD/VOSBs added keyword, TheraSphere, resulted 0 SD/VOSBs. However as mentioned above Boston Scientific is the sole provider, a large business. The VA Rule of Two is Unattainable. The BAA and TA are not applicable to this requirement. Procurement of domestic end products. Products comply with the Buy American Act. Furniture, IT hardware, software, medical products, or paper products are commercial items and are not produced in non-designated countries. Products comply with the Trade Agreements Act. 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: Boston Scientific 500 Commander Shea Blvd. Quincy, MA 02171 Dorothy Chamblitt (888) 812-1303 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: We will continue to survey the market for any future same or similar requirement. 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. _____________________________ Jaymie Claytor Supervisory Nuclear Medicine Cleveland VA Medical Center Approvals in accordance with the VHAPM Part 806.3 OFOC SOP: Contracting Officer or Designee s 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 NCO 10 Dayton
 

Web Link

SAM.gov Permalink
(https://sam.gov/opp/3808bde453584873827134e07c11b98f/view)
 

Place of Performance

Address: Louis Stokes Cleveland VAMC Wade Park Campus Nuclear Medicine Service, Room BC446 10701 East Blvd., Cleveland, OH 44106, USA

Zip Code: 44106

Country: USA
 

Record

SN06496717-F 20221020/221018230120 (samdaily.us)
 

Source

SAM.gov Link to This Notice
(may not be valid after Archive Date)

---

| FSG Index  |  This Issue's Index  |  Today's SAM Daily Index Page |