Inactive

1. This is a combined synopsis/solicitation for commercial services/items prepared in accordance with the format in FAR Subpart 12.6 in conjunction with FAR Part 13, as supplemented with additional in... 1. This is a combined synopsis/solicitation for commercial services/items prepared in accordance with the format in FAR Subpart 12.6 in conjunction with FAR Part 13, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a separate written solicitation will not be issued. 1.a. Project Title: Radiopharmaceutical Supplies-NETSPOT (Gallium 68 Dotatate). 1.b. Description: VA Loma Linda Healthcare System is seeking to provide Radiopharmaceutical Supplies-NETSPOT (Gallium 68 Dotatate). 1.c. Project Location: VA Loma Linda Healthcare System, 11201 Benton St, Loma Linda, CA 92357 1.d. Solicitation Type - Number: Request for Quotes (RFQ) - 36C26222Q1022. 1.e. Set Aside: This solicitation is issued as an unrestricted open market procurement. 1.f. Applicable NAICS code: 325412, Pharmaceutical Preparation Manufacturing. 1.g. Small Business Size Standard: 1250 employees 1.h. Type of Contract: Firm Fixed Price 1.i. Period of Performance: Base year plus 4 options. 1.j. Request for Information (RFI) should be submitted via email no later than 1pm PST Monday June 6th, 2022, to Ositadima.ndubizu@va.gov 2. Statement of Work 2.1. Objective. VA Loma Linda Healthcare System is seeking to provide Radiopharmaceutical Supplies-NETSPOT (Gallium 68 Dotatate). 2.2. Background. All Radiopharmaceutical Supplies shall be provided in accordance with the terms and conditions, and provisions of this solicitation for the base year period with the Government s option to extend the contract for four (4) additional one-year periods. 2.3. Scope. The supplies must have the following salient characteristics: . Ga 68 Dotatate injection, a radioactive diagnostic agent for positron emission tomography (PET) imaging. This radioactive probe is used for diagnosing and staging to find Neuroendocrine tumors (NET) throughout the body. Gallium-68 decays with a half-life of 68 minutes to stable zinc Zn 68 10% through orbital electron capture (X-ray or Auger emissions), and 3% through 13 gamma transitions from 5 exited levels. The effective radiation dose resulting from the administration of 150 MBq (4.05 mCi) [within the range of the recommended Ga 68 Dotatate injection dose] to an adult weighing 75 kg, is about 3.15 mSv. For an administered activity of 150 MBq (4.05 mCi) the typical radiation dose to the critical organs, which are the urinary bladder wall, the spleen and the kidneys/adrenals, are about 18, 16 and 12 mGy, respectively. Because the spleen has one of the highest physiological uptakes, higher uptake and radiation dose to other organs or pathologic tissues may occur in patients with splenectomy. Physical data Gamma constant: 0.67 mrem/hr per mCi at 1 meter [1.8E-4 mSv/hr per MBq at 1 meter]. Specific Activity: 4.1E7 Ci/g [1.51E18 Bq/g] max 2. Shielding Lead [Pb] Half Value Layer [HVL]: 6 mm (0.24 in) Tenth Value Layer [TVL]: 17 mm (0.67 in 2.3. General Requirements. ROUTINE ORDERS Routine orders require delivery the next business day, unless specified elsewhere in this contract. EMERGENCY ORDERS An emergency delivery requires same day delivery and with the time specified during the placement of order. DELIVERY LOCATION, NORMAL WORK HOURS AND INSTRUCTIONS: Time of delivery specified or mutually agreed to at the time of receipt of telephone orders shall become mandatory upon the Contractor s acceptance to commitment. Delivery of supplies by the scheduled time will be complete except as otherwise authorized by Government personnel. If the Contractor cannot make delivery and an outside source must be utilized, the Contractor will be responsible for paying the difference in cost. VA LOMA LINDA HEALTHCARE SYSTEM (VALLHCS): Delivery Location Nuclear Medicine Section, Imaging Service. Main hospital, 4th Floor, Room 4E15, Extension 2669. Normal Work Hours 8:00am to 4:00pm, Monday through Friday Instruction 1) Delivery shall be next business day. UNIT DOSE ITEMS For unit-dose items, products shall be pre-drawn into a syringe, calibrated and delivered at time specified when ordered. The word Dose represents the maximum size potency per unit price; however, order may be less. The government will pay the cancellation fee for any canceled order. PACKAGING AND MARKING The contractor shall package, mark and transfer all radioactive material in accordance with all applicable local, state, and federal regulations. Items must be adequately packaged to prevent damage during shipping, handling, and storage. All outer packages must contain the complete purchase number, obligation number and contract number in addition to the shipping address. The purchase number and obligation number will be provided by the individual at the time of ordering. The contract number will be provided upon notice of contract award. Packaging List: A packing list/slip shall be enclosed with each shipment indicating the purchase/obligation and delivery order number, contract number, items/quality ordered, and items/quality shipped. The Contractor shall provide MSDS sheets (Material Safety Data Sheets) and updates as necessary on all delivered products. QUALITY ASSURANCE The quantity of radioactivity for supplied radiopharmaceuticals will not deviate more than + or 10% for therapeutic doses; = or 20% for imaging doses at the time of calibration, from the quantities specified. The Contractor will perform all quality control procedures on each radiopharmaceutical according to applicable requirements of licensing authorities and other regulating bodies. A copy of the results of the quality control procedures must be made available to VALLHCS upon request. In the event that a quality control or material defect is suspected and/or detected by the Contracting Officer Representative (COR), the Contractor will be requested to provide any consultation necessary to alleviate any said suspicion and/or defect by the following: Provide technical expertise in calibration. Provide professional examination of product; submit results and recommendations to the Contracting Officer. Make expedient replacement of any product suspected of being deficient. The Contractor shall make quality control records available to VALLHCS upon written request from the Contracting Officer The Contractor must provide waste disposal at no additional charge of used radioactive dose syringes, vials, etc.; unless otherwise stipulated or prohibited by licensure or regulatory requirements. The Contractor shall provide any additional technical support deemed necessary for the technical staff, physicians, and patient education. Any recalled dose for any reason shall be credited to the Government for the full amount. Any individual doses shall be traceable to the original elution if requested by the Government as per VISN 22 pharmacy standards and regulations. Any dose deemed below standard by the facility shall be credited toward the account. This shall be determined by the Authorized User or COR. Substitutions or Generic Brands may only be used with the express permission of the facility. Items shall be bar-coded and be compatible with the existing NMIS System. The Contractor shall meet all requirements of regulatory agencies for deliveries of radioactive isotopes between facilities and shall strictly adhere to these requirements. Deliveries not properly handled according to regulations will not be accepted. The Contractor shall be responsible for all costs incurred for any radiopharmaceutical and nonradioactive items contracted must find alternate supplier for the contracted items. In the event of a manufacturer or pharmacy recall or quality assurance failure, the Contractor shall notify VALLHCS Nuclear Medicine Department immediately. A radio-pharmacist in the employ of the successful Contractor must be available to: Set-up the quality assurance program on the radiopharmaceutical preparations required by Food and Drug Administration (FDA), Nuclear Regulatory Commission (NRC), United States Pharmacopeia (USP), and the Joint Commission. Act as a reference source concerning questions on the regulation of radiopharmaceuticals. Provide reference services for research drugs and radionuclides under research protocols. Provide instruction (continuing education) to the technologists on new changes in radiopharmaceutical products and availability. RECALLED AND DEFECTIVE PRODUCTS The Contractor will immediately notify the Contracting Officer of any recalls of product or other important product safety issues. As appropriate, the Contractor will replace and/or reimburse recalled / defective products at no cost to the Government. The Contractor may be liable for costs of processing recalls, i.e., administrative and clinical services to replace recalled / defective products. CERTIFICATION AND LICENSING REQUIREMENT Pharmacists employed by the Contractor shall be an authorized user on the Contractor s Radioactive Materials License. The Pharmacy of the Contractor shall be licensed by the State of Operation and by the Nuclear Regulatory Commission or Agreement State Agency. SAFETY GUIDELINES AND REQUIREMENTS Delivery personnel shall be trained in Radiation Safety Techniques, Nuclear Regulatory Commission, Joint Commission safety guidelines and Department of Transportation requirements PLACEMENT OF VERBAL ORDERS Contractors shall provide on a separate sheet of paper, the name, location, and telephone number of the office where the participating VA facility will call to place orders. The sheet of paper will go to the Point of Contact (POC) or alternative Point of Contact (POC). INVOICE AND PAYMENT No advanced payments will be authorized. The contractor shall submit invoices on a monthly basis. The invoice must have at a minimum, the contract number, assigned purchase order, assigned obligation number, date order was placed, date order was shipped, and any additional necessary detailed information to identify service rendered. Payment on invoice may be delayed in invoice(s) are not completed properly. 2.5. Performance Monitoring. The Contracting Officer Representative (COR) or Designee will monitor contractor performance. 2.6. Period of Performance. The period of performance will be base year plus 4 options. a. National Holidays: New Year s Day January 01 Martin Luther King s Birthday Third Monday in January President s Day Third Monday in February Memorial Day Last Monday in May Independence Day July 04 Labor Day First Monday in September Columbus Day Second Monday in October Veterans Day November 11 Thanksgiving Day Fourth Thursday in November Christmas Day December 25 b. If the holiday falls on a Sunday, the following Monday will be observed as a national holiday. When a holiday falls on a Saturday, the preceding Friday is observed as a National holiday by U.S. Government Agencies, and any day specifically declared by the President of the United States of America. c. Overtime & Holiday Pay: Any overtime and/or holiday pay that may be entitled to the Contractor s employees shall be the sole responsibility of the Contractor and shall not be billed to nor reimbursed by the Government. 2.6. Insurance Coverage The Contractor agrees to procure and maintain, while the contract is in effect, Workers Compensation and Employee s Public Liability Insurance in accordance with Federal and State of California laws. The Contractor shall be responsible for all damage to property, which may be done by him, or any employee engaged in the performance of this contract. The Government shall be held harmless against any or all loss, cost, damage, claim expense or liability whatsoever, because of accident or injury to persons or property of others occurring in the performance of this contract. Before commencing work under this contract, the Contracting Officer shall require the Contractor to furnish certification from his/her insurance company indicating that the coverage specified by FAR 52.228-5 and per FAR Subpart 28.307-2 has been obtained and that it may not be changed or canceled without guaranteed thirty (30) day notice to the Contracting Officer. The Contractor shall furnish to the Contracting Officer within fifteen (15) days of award an Official Certification from the insurance company indicating that the coverage has been obtained and that it may not be changed or cancelled without guaranteed thirty (30) day notice to the Contracting Officer. New certifications shall be furnished at least thirty (30) days prior to the expiration date of the current insurance policy. The phrase will endeavor is not acceptable terms to the Government and such coverage carrying that phrase will be rejected and services may not be rendered until proper certificate is issued. 3. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2020-01, dated 10/10/2019. The following provisions and clauses apply to this solicitation and can be found in enclosure 2. 3.a. FAR 52.212-1, Instructions to Offerors Commercial Items 3.b. FAR 52.212-2, Evaluation -- Commercial Items 3.c. FAR 52.212-4, Contract Terms and Conditions -- Commercial Items 3.d. FAR 52.212-5, Contract Terms and Conditions Required To Implement Statutes Or Executive Orders -- Commercial Items 3.e. Supplemental Insurance Requirements 3.f. VAAR 852.219-10, VA Notice of Total Service-Disabled Veteran-Owned Small Business Set-Aside 3.g. VAAR 852.219-74, Limitations on Subcontracting Monitoring and Compliance 3.h. FAR 52.233-2, Service of Protest 3.i. VAAR 852.233-70, Protest Content/Alternative Dispute Resolution 3.j. VAAR 852.233-71, Alternative Protest Procedure 4. Submit written offers in accordance with the following instructions, as well as Addendum to FAR 52.212-1, Instruction to Offerors. Oral offers will not be accepted. Complete and submit enclosure 1 via email no later than 10am PST Friday June 10th, 2022, to Ositadima.ndubizu@va.gov. Ensure the following are completed and/or included in the quote packet: 4.3.a. Vendor Information with UEI number 4.3.b. Acknowledgement of amendments 4.3.c. Concurrence/non-concurrence with solicitation terms, conditions, and provisions 4.3.d. Schedule of supplies (Company Information and quote should be entered on the attached Enclosure 1 form) 4.3.e. FAR 52.212-3, Offeror Representations and Certifications -- Commercial Items