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FBO DAILY - FEDBIZOPPS ISSUE OF OCTOBER 31, 2019 FBO #6549
DOCUMENT

65 -- Intent to Sole Source AXUMIN F-18 Fluciclovine - Attachment

Notice Date

10/29/2019
 

Notice Type

Attachment
 

NAICS

325412 — Pharmaceutical Preparation Manufacturing
 

Contracting Office

Department of Veterans Affairs;VISN 7 Network Contracting Office;LaVista Business Park - Bldg A;2008 Weems Road;Tucker GA 30084
 

ZIP Code

30084
 

Solicitation Number

36C24720Q0041
 

Archive Date

11/28/2019
 

Point of Contact

Denedra Threatt
 

Small Business Set-Aside

N/A
 

Description

The Department of Veterans Affairs, NCO 7, intends to award a sole source contract to TrillaMed, LLC, 30100 Telegraph Rd., Suite 366 Bingham, MI 48025. Requirement is to provide Radiopharmaceutical supplies and services for the Charlie Norwood VA Medical Center (CNVAMC) in Augusta, GA. This is a Firm-Fixed Pricing. Contract will include a base year and four (4) additional option years, for a total of five (5) years. Interested persons may identify their interest and capability to respond to the requirement or submit proposals. This notice of intent is not a request for competitive proposals or a solicitation for offers. However, parties interested in responding to this notice shall submit technical data, including cost, sufficient to determine capability in providing the same product to Denedra Threatt, Contract Specialist at Denedra.threatt@va.gov. Phone number: 404-321-6111 Ext: 201435 by 1500 EST November 5, 2019. All capability statements received by the closing date of this notification of this synopsis will be considered by the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. This acquisition is being conducted under FAR Part 12 commercial procedures. There are no set-aside restrictions for this requirement. The intended procurement will be classified under North American Industry Classification System (NAICS) 325412- Pharmaceutical Preparation Manufacturing. This is for informational purposes only and not to be considered as a commitment by the Government. Any information submitted to this notice of intent is voluntary. Requirement: GENERAL INFORMATION 1. Title of Project: Radiopharmaceutical supplies and services for the Charlie Norwood VA Medical Center (CNVAMC) in Augusta, GA. The Contractor shall provide F-18 Axumin (fluciclovine) for Prostate Cancer imaging to the Charlie Norwood VA Medical Center (509), Downtown Division, 2D-149G, 950 15th Street Augusta, GA 30901, during normal working hours. 3. Background: The Charlie Norwood VA Medical Center in Augusta, Georgia has a continuous need for Radiopharmaceutical / Nuclear medicine supplies and delivery services. CNVAMC has historically awarded to a Contractor that provides radiopharmaceutical doses that are compounded and calibrated by or under the supervision of a certified Nuclear Medicine pharmacist. 4. Performance Period: Firm-Fixed-Price. The Contractor shall complete the work required under this SOW in 365 calendar days from date of award, unless otherwise directed by the Contracting Officer (CO). The Contractor shall provide Radiopharmaceuticals during standard hours of care Monday through Friday from 0800 (8:00 AM EST) until 1700 hours (5:00 PM EST), excluding Federal holidays. 5. Type of Contract: Firm-Fixed-Price. B. CONTRACT AWARD MEETING The Contractor must be licensed to prepare and distribute radiopharmaceuticals by the US Nuclear Regulatory Commission (USNRC) or Agreement State. A copy of the license must be provided to CNVAMC. The Contractor shall not commence performance on the tasks in this SOW until the CO has conducted a kick off meeting or has advised the Contractor that a kick off meeting is waived. The Contractor must employ licensed Nuclear Pharmacists to oversee daily operations. A license for each pharmacist must be provided to CNVAMC. The Contractor must be financially responsible and able to provide past performance evidence of their reliability, ability, experience, equipment, facilities and personnel to provide prompt satisfactory service. Regulatory inspection reports must be provided to CNVAMC when they occur. This shall include any Notices of Violation and the corrective actions taken by the Contractor. C. GENERAL REQUIREMENTS 1. Hours of Operation: The Contractor will deliver the ordered Radiopharmaceutical doses to the Nuclear Medicine between the hours of 8:00a 17:00p (EST) (Monday thru Friday) on the day specified to ensure proper inventory and receipt of the shipment is done by qualified personnel. 2. The Contractor will deliver all after hour orders of Radiopharmaceuticals within two hours of the Radiopharmaceutical doses being ordered to Imaging Nuclear Medicine. Routine next day orders shall be placed by 17:00 hours the day before. Confirmed orders will be made during normal pharmacy business hours with a 48-hour notice to the pharmacy. The Customer must contact PETNET s Customer Care Team (CCT) at (877) 473-8638 48 hours in advance. To cancel an order, Customer must notify PETNET s Customer Care Team (CCT) at (877) 473-8638 by 08:00 am (EST) on the day of the patient exam or Customer will be responsible for payment. The preferred method of next day orders is electronically via hot lab patient tracking or internet portal. Orders shall be made by Nuclear Medicine Technologists designed by the Contracting Officer Representative (COR). The names of these individuals shall be provided to the Contractor. 3. Delivery of Product: a. All packages containing radioactive material shall be labeled and shipped in accordance with Title 49, Code of Federal Regulations Part 172 and 173. Compliance with all applicable regulatory bodies, including FDA and US DOT is required. b. Routine deliveries shall be made on an as needed basis, during normal working hours, by the Contractor to room 2D-149G, located inside of Nuclear Medicine, at no additional cost to CNVAMC. c. All delivery personnel are required to have background checks completed prior to delivering products to CNVAMC. The Contractor is to work with the COR to ensure this is completed within a 3-month time frame after the issue of the contract. Due to the short half-life of the isotope, the Contractor must be within 90 minutes of CNVAMC to ensure delivery of F-18 AXUMIN (fluciclovine) delivery. d. The Contractor will calibrate all Radiopharmaceutical doses to ensure proper activity ranges of +/- 10 percent of the specified ordered dose based on specific requirements provided by Nuclear Medicine Clinic based on guidelines outlined in 10 CFR Part 35.63. e. The Contractor shall provide a daily invoice accompanying all Radiopharmaceutical shipments to Imaging Nuclear Medicine for all orders placed. f. The Contractor will ensure that all Radiopharmaceutical doses provided are compounded and calibrated by or under the supervision of a certified Nuclear Medicine Pharmacist. g. The Contractor shall provide courier service that is in accordance with Department of Transportation, Nuclear Regulatory Commission and other applicable regulating authorities enabling the delivery of all Radiopharmaceuticals. All couriers shall be licensed and shall submit all required paperwork to be granted access to the downtown division of the Charlie Norwood VA Medical Center, Augusta Georgia. The Contractor shall be responsible for the removal of all used and unused radiopharmaceutical doses from the clinic within 72 hours of delivery. h. The Contractor shall notify the Charlie Norwood VA Medical Center Imaging Department, Nuclear Medicine immediately should the inability to provide Radiopharmaceutical doses arise. i. The radioisotope shall be delivered as a unit dose in shielded containers. Each unit dose shall meet the labeling requirements outlined in USNRC regulations outlined in 10 CFR Part 35.69. All unit doses must have the following: 1. Customer Name, manufacturer, and Ordering Physician 2. Procedure and Radiopharmaceutical Name 3. Calibration Activity (mCi/uCi), Volume, Date and Time 4. Prescription Number, Lot Number, Expiration Date and Time 5. An additional label containing the above information shall also be affixed to the dose syringe or other container being utilized. 6. Each unit dose must contain a bar code so that dose information can be scanned into the Nuclear Medicine patient Tracking System. 7. The Contractor shall perform all necessary quality control procedures in accordance with Title CFR Part 35.7, and any other Federal/State regulations that are applicable to the radio pharmacy industry. Quality control results will be furnished to CNVAMC upon request. D. SPECIFIC MANDATORY TASKS AND ASSOCIATED DELIVERABLES Description of Tasks and Associated Deliverables: The Contractor shall provide the specific deliverables described below within the performance period stated in Section A.4 of this SOW. Task One: The Contractor shall provide any training or education required to meet commercial standards related to use of radiopharmaceuticals to all staff Nuclear Medicine Technologists stationed at the Charlie Norwood VA Medical Center. Deliverable One: Provide training as needed or as scheduled with the COR. Task Two: The Contractor shall be able to provide a Nuclear Medicine management program. This program shall provide all necessary software and hardware maintained by the Contractor. The management program shall allow for the receipt, inventory and proper documentation of Radiopharmaceutical doses dispensed. Deliverable Two: Provide software and hardware to manage radiopharmaceutical supplies and services. E. EVALUATED OPTIONAL TASKS AND ASSOCIATED DELIVERABLES Optional Task One: None SCHEDULE FOR DELIVERABLES If for any reason any deliverable cannot be delivered within the scheduled time frame, the Contractor is required to explain why in writing to the CO, including a firm commitment of when the work shall be completed. This notice to the CO shall cite the reasons for the delay, and the impact on the overall project. The CO will then review the facts and issue a response, in accordance with applicable regulations. CHANGES TO STATEMENT OF WORK Any changes to this SOW shall be authorized and approved only through written correspondence from the CO. A copy of each change will be kept in a project folder along with all other products of the project. Costs incurred by the Contractor through the actions of parties other than the CO shall be borne by the Contractor. REPORTING REQUIREMENTS The Contractor shall provide a daily invoice accompanying all Radiopharmaceutical shipments to Imaging Nuclear Medicine for all orders placed. Monthly invoices for payment shall be transmitted electronically. The COR shall be provided with copies of the invoices for review prior to being submitted. Invoices shall be paid to the contractor monthly, in arrears, upon submission of a property prepared invoice for services/supplies during the period. All invoices will include name of company, address, point of contact, contract number, dates of service, purchase order number, invoice number and an itemized listing of charges. Contractor invoices shall be sent to Austin, Texas for on-line certification and entered into the IPPS system for invoicing payment. I. TRAVEL Travel or courier service is expected to and from the CNVAMC site and Contractor s location. The Contractor will deliver all after hour orders of Radiopharmaceuticals within two hours of the Radiopharmaceutical doses being ordered. The Contractor shall provide a daily invoice accompanying all Radiopharmaceutical shipments to Nuclear Medicine for all orders placed. J. GOVERNMENT RESPONSIBILITIES The Contractor will be contacted by Staff, Nuclear Medicine Technologists assigned to the Nuclear Medicine Department at the Charlie Norwood VA Medical Center. All routine orders for Radiopharmaceutical doses will be placed to the Contractor the day prior before the clinic close of business via phone. The order will include specified activities of doses and calibration times. K. CONTRACTOR EXPERIENCE REQUIREMENTS The government will determine on a SR basis what positions are considered key personnel. The Contractor shall identify, by name, the key management and technical personnel who will work under this task order at the time the work is being negotiated. If a key person becomes unavailable to complete the SR, the proposed Substitutions of key personnel shall be made only as approved directed by the Contracting Officer and the COTR. The government will not dictate specific experience and education requirements of the employees initially proposed to perform the work stated herein. The Contractor shall submit a resume of qualifications for the COTR and all other direct employees proposed for the project. All Contractor employees will be approved by the COTR prior to bringing on duty. If, at any time from date of award to the end of the contract, non-key personnel Contractor personnel are no longer available, HES/HIS reserves the right to review the qualifications of the proposed replacement personnel and to reject individuals who do not meet the qualifications set forth in the TLO. Team personnel proposed by the Contractor should possess some of the following knowledge and/or skills: The Contractor must notify VHA in advance and we will approve or reject proposed Contractor key personnel for the performance of this contract. The Contractor shall submit a resume of qualifications to the COTR for key personnel and all other direct employees proposed for the project. All Contractor employees will be approved by the COTR prior to bringing on duty. If, at any time from date of award to the end of the contract, Contractor personnel are no longer available, the VHA will approve the qualifications of proposed replacement personnel and will reject individuals who do not meet qualifications set forth herein. The Contractor must inform the VHA COTR, and Project Manager/Task Manager when personnel are removed from the contract for any reason. The Contractor shall remove any employee from the performance of this contract within five (5) workdays of receiving notice from the Contracting Officer that the employee's performance is unsatisfactory. All Contractor employees are subject to immediate removal from performance of this contract when they are involved in a violation of the law, VA security, confidentiality requirements and/or other disciplinary reasons. The Contractor must inform the VHA COTR, and Project Manager/Task Manager when personnel are removed from the contract for any reason. If a key person becomes unavailable to complete the SR, proposed Substitutions of key personnel shall be made only if approved by the COTR and Project Manager. The Contractor shall submit a resume of qualifications to the COTR for all direct employees proposed for the project. All Contractor employees will be approved by the COTR prior to bringing on duty. L. CONFIDENTIALITY AND NONDISCLOSURE It is agreed that: 1. The preliminary and final deliverables, and all associated working papers, application source code, and other material deemed relevant by VA which have been generated by the Contractor in the performance of this task order, are the exclusive property of the U.S. Government and shall be submitted to the CO at the end of the task order. 2. The CO will be the sole authorized official to release, verbally or in writing, any data, draft deliverables, final deliverables, or any other written or printed materials pertaining to this task order. No information shall be released by the Contractor. Any request for information relating to this task order, presented to the Contractor, shall be submitted to the CO for response. 3. Press releases, marketing material, or any other printed or electronic documentation related to this project, shall not be publicized without the written approval of the CO. CONTRACTOR PERSONNEL SECURITY REQUIREMENTS All Contractor employees who require access to the Department of Veterans Affairs computer systems shall be the subject of a background investigation and must receive a favorable adjudication from the VA Office of Security and Law Enforcement prior to contract performance. This requirement is applicable to subcontractor personnel requiring the same access. Position Sensitivity The position sensitivity has been designated as ____________________ (Insert High Risk, Moderate Risk or Low Risk.) Background Investigation The level of background investigation commensurate with the required level of access is ____________ (Insert Background Investigation, Minimum Background Investigation or National Agency Check with Written Inquiries). Contractor Responsibilities The Contractor shall prescreen all personnel requiring access to the computer systems to ensure they maintain a U.S. citizenship, and are able to read, write, speak and understand the English language. The Contractor shall submit or have their employees submit the required forms (SF 86 or SF 85P, SF 85P-S, FD 258, Contractor Fingerprint Chart, VA Form 0710, Authority for Release of Information Form, and Optional Forms 306 and 612) to the VA Office of Security and Law Enforcement within 30 days of receipt. The Contractor, when notified of an unfavorable determination by the Government, shall withdraw the affected employee from working under the contract. Failure to comply with Contractor personnel security requirements may result in termination of the contract for default. 4. Government Responsibilities The VA Office of Security and Law Enforcement will provide the necessary forms to the Contractor, or to the Contractor s employees, after receiving a list of names and addresses. Upon receipt, the VA Office of Security and Law Enforcement will review completed forms for accuracy and forward the forms to the office of Personnel Management (OPM) to conduct background investigations. The VA Office of Security and Law Enforcement will notify the CO, and Contractor, of adjudication results received from OMB. Upon being notified about a favorable determination, the CO may issue a notice to proceed to the Contractor. Attachment A to the Statement of Work Schedule of Deliverables Deliverable No. One Item Provide any training or education required to meet commercial standards related to use of radiopharmaceuticals Quantity 1 Delivery Date Within _20__ calendar days after award Two etc. Nuclear Medicine management program (Hardware and Software) 3 EA Within _30__ calendar days after award
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/AtlVAMC/VAMCCO80220/36C24720Q0041/listing.html)
 

Document(s)

Attachment
 

File Name: 36C24720Q0041 36C24720Q0041_1.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=5205745&FileName=36C24720Q0041-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=5205745&FileName=36C24720Q0041-000.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Record

SN05485222-W 20191031/191029230628-37d118d3f08e338f428daafc1ce836cf (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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