6505--Supplies - Radioactive Isotopes - Ann Arbor - Sources Sought


Subject: 6505--Supplies - Radioactive Isotopes - Ann Arbor - Sources Sought
Solicitation Number: 36C25021Q0789
Notice Type: SRCSGT
NAICS: 325412
Notice Published: 06-10-21
Response Due: 06-18-21

Agency: Department of Veterans Affairs
Office: VETERANS AFFAIRS, DEPARTMENT OF
Contact: Kellie Konopinski, Contracting Officer This email address is being protected from spambots. You need JavaScript enabled to view it. Ph: (734) 222-4330
Office Address: DAYTON, OH 45428
Place of Performance: VA Ann Arbor Healthcare System 2215 Fuller Road, Ann Arbor 48105


Click for official SAM (FBO) notice, additional information, and accompanying attachments

This is a SOURCES SOUGHT only pertaining to item(s) for the Ann Arbor VA healthcare facility. Information collected during this Sources Sought may be used in a set aside. If a solicitation is issued, the Government will do so in accordance with Federal Acquisition Circular (FAC) 2005-83. The North American Industry Classification System (NAICS) number is 325412. The NAICS size is 1250 employees. Any contractor that believes they are capable and desires to claim preference for small business status must be registered with the SBA at http://web.sba.gov/pro-net/ and meet the requirements of FAR 19.102. Any contractor that believes they are capable and desires to claim preference for veteran owned small business status must be registered with the VIP at https://www.vip.vetbiz.gov as an SDVOSB or VOSB. A Contractor that proposes to provide a supply that is not manufactured by their organization (nonmanufacturer) shall meet the requirements of 52.219-33. Contractors that deem themselves capable of meeting the requirement shall provide the below information to Kellie Konopinski, Contracting Officer, at This email address is being protected from spambots. You need JavaScript enabled to view it. no-later-than Friday, June 18, 2021 at 4:30PM, EDT, referencing (36C25021Q0789). Responses shall include: (1) Business Name and Address (2) GSA Contract Number, if applicable (3) Point of Contact Name, Phone Number and E-mail Address (4) DUNS and NAICS code (5) Business Size SMALL or LARGE (6) Type of Business: service-disabled veteran owned, veteran owned small business, 8a, HUBZone, woman-owned, etc. (7) A concern that is not a manufacturer of the supply shall provide the manufacturers name and size standard. If the concern is the manufacture and the sole distributor, please provide documentation to that effect. (8) Contractor must confirm they can provide ALL items on the SOW. Contractor must be registered with https://www.sam.gov To be considered SDVOSB/VOSB, must be registered in VIP (https://www.vip.vetbiz.gov/). Supplies are to include only TAA compliant items. Items that are not TAA compliant must be clearly identified by the Contractor should the contractor choose to offer a quote if a RFQ is published. FOB is Destination. Delivery is to: VA Ann Arbor Healthcare System 2215 Fuller Rd. Ann Arbor, MI 48105 Requirement: Nuclear Medicine Radioactive Isotopes, Radiopharmaceutical Kit Vials, and Chromatography Supplies 1.0 Summary: The VA Ann Arbor Healthcare System (VAAAHS) has a requirement for radiopharmaceuticals and radioactive sources for the nuclear medicine department. Due to the terms of United States Pharmacopoeia USP<825>, the medical center can no longer compound radioisotopes in the facility s existing hot lab. It is necessary to obtain these products and services that are both vital and critical to patient care from an outside nuclear pharmacy. Contractor shall furnish radioactive isotopes, vial kits, and chromatography supplies for diagnostic imaging, therapies, research, and equipment quality control in accordance with the terms and conditions of this contract for the period of October 1, 2021 through September 30, 2026.( Option years 2022-2026) 2.0 Requirements: Contractor must be licensed by the U.S. Nuclear Regulatory Commission (USNRC), or a State with a formal Agreement with the USNRC that allows the State to regulate radioactive materials (Licensee), and be regularly established in the business of providing radiopharmaceuticals at the scale and frequency necessary to meet this requirement. The Radiopharmaceuticals must be shipped from the Licensee directly to locations of use requested by the VAAAHS. Non-manufacturing waiver is not applicable to this solicitation. Contractor/licensee shall meet all applicable USNRC, Department of Veterans Affairs National Health Physics Program (NHPP), Department of Transportation (DOT), Food and Drug administration (FDA), State, and Federal requirements, rules, and/or regulations related to the supply of Radiopharmaceuticals. In accordance with Presidential/White House request for preferential procurement made to the Veterans Health Administration (VHA), >90% of Technetium-99m unit doses will be derived from Non-High Enriched Uranium-235 (Non-HEU) sources, also known as Low Enriched Uranium-235 (LEU) sources. Pricing should include cost for both LEU and non-LEU derived Technetium-99m to account for those instances were product availability becomes limited. The contractor will meet all radiopharmaceutical requirements for VAAAHS (both the Ann Arbor VAMC and VA Toledo Outpatient Clinic locations) in unit dose form. (See Schedule of Supplies/Services) The contractor will provide Non-Highly Enriched Uranium radiopharmaceuticals whenever possible in accordance with the VHA Memorandum dated 01-03-2014 from the VA Under Secretary for Health. (See Attachment A) The contractor shall provide radioactive sealed sources necessary for patient care and quality control (See Schedule of Supplies/Services). The contractor shall provide radioactive material in the form requested by VAAAHS for equipment quality control testing. All packages containing radioactive material must be labeled and shipped in accordance with Title 49, Code of Federal Regulations (CFR) Part 172 and 173, and Title 10, CFR Part 71. Contractor/licensee shall perform all quality control procedures as required by Federal, and when applicable, State regulatory agencies. Quality Control results will be furnished to VAAHS upon request. Contractor/supplier shall abide by Title 10, CFR, which states: A Licensee may use for medical purposes only: (a) By-product material or cyclotron produced materials manufactured, labeled, packaged, and distributed in accordance with a license issued pursuant to the regulations in Title 10, CFR, Part 35 and/or the equivalent regulations of an Agreement State. (b) Reagent kit that has been manufactured, labeled, packed and distributed in accordance with approval by the NRC pursuant to Title 10 CFR 32.72 or an Agreement State under equivalent regulations for the preparation of radiopharmaceuticals for medical use. The contractor shall provide Radiopharmaceuticals during standard hours of care Monday through Friday from 0630 (AM EST) until 1600 hours (4:00 PM EST), not including Federal holidays. The contractor shall provide after-hours coverage 24 hours per day Saturday and Sunday, and on Monday through Friday from 1600 (4:00PM EST) until 0630 hours including Federal holidays. Radioactive sealed sources will be delivered during normal business hours Monday through Friday from 0630- 1600 (4:00 PM EST). Federal holidays include the following: New Year s Day Martin Luther King Day Presidents Day Memorial Day Independence Day Labor Day Columbus Day Thanksgiving Day Christmas Day Federal holidays also include any day specifically declared by the President of the United States as a holiday. NOTE: If the holiday falls on a Saturday, it will be officially observed on the Friday before the holiday. If the holiday falls on a Sunday, it will be officially observed on the Monday following the holiday. For the placement of orders, the contactor will be contacted by staff nuclear medicine technologists assigned to the nuclear medicine department at Ann Arbor VA Medical Center and VA Toledo Outpatient Clinic. All routine orders for Radiopharmaceutical doses will be placed via phone, fax, or internet with the contractor one day before they are needed and prior to the VA Nuclear Medicine Clinic close of business. The order shall include specified activities of doses, calibration times, and patient name. The contractor shall deliver the first run of ordered Radiopharmaceutical doses to Ann Arbor VA Medical Center, 2215 Fuller Road, Ann Arbor, MI 48105, Nuclear Medicine Clinic, Room D764 and Room D734 between 0630-0645 (AM EST). The Contractor shall deliver the first run of ordered Radiopharmaceutical doses to the Toledo Outpatient Clinic, 1200 S Detroit Ave, Toledo, OH 43614 Toledo Nuclear Medicine Clinic Room 1-310 between 0730-0745 (AM EST) on the day specified to ensure proper inventory and receipt of the shipment is done by qualified personnel. The contractor shall deliver a subsequent run of ordered radiopharmaceuticals by 1130 (EST) and, if necessary, shall deliver a third run prior to the close of business for all add-on procedures ordered. Same-Day Add-on Delivery of routine non-Emergent radiopharmaceutical can be received at Ann Arbor VAMC or TOPC facilities up to 120 minutes after the order is placed during normal business hours if approved by VAAAHS authorized personnel. All emergency STAT orders or after hour orders of radiopharmaceutical doses shall be placed by staff Nuclear Medicine Technologist on an emergency need basis. The contractor shall deliver all emergency STAT orders of Radiopharmaceuticals within 90 minutes of the Radiopharmaceutical doses being ordered to the Nuclear Medicine Clinic, Room D764, D734, or Toledo Room 1-310. The contractor shall 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. Radiopharmaceutical Returns for Credit: Ann Arbor VAMC and TOPC facilities require the Contractor to accept returns for full credit toward future orders under the following conditions: (a) Product(s) ordered or shipped in error. (b) Product(s) damaged in shipment (c) Concealed shipping damages (d) Recalled product(s) (e) Outdated products in unopened, original container. The contractor shall provide a daily packing slip accompanying all Radiopharmaceutical shipments to the Nuclear Medicine Clinic for all orders placed. The packing slip shall include a bar code that works with the Nuclear Medicine Information System (NMIS) for tracking purposes. The contractor shall be able to work within NMIS, the current Nuclear Medicine management program at Ann Arbor VAMC and TOPC. This shall allow for the receipt, inventory and proper documentation of Radiopharmaceutical doses dispensed. The contractor shall ensure that all Radiopharmaceutical doses provided are compounded and calibrated by or under the supervision of a certified Nuclear Medicine Pharmacist. The contractor shall provide courier service that is in accordance with DOT, USNRC and other applicable regulating authorities enabling the delivery of all Radiopharmaceuticals. All couriers shall be licensed. Couriers shall submit all paperwork required for access to Ann Arbor VA Medical Center and TOPC. The contractor shall be responsible for the removal of carrier containers and empty non-radioactive shielded carriers (lead pigs, lead vial containers, etc ) from the clinic within 72 hours of delivery. All couriers will deliver product through the facility via approve route by facility VA Police. Approved route information will be provided by VA Ann Arbor Nuclear Medicine Department or Radiation Safety Officer. The contractor shall notify Ann Arbor VAMC Nuclear Medicine Clinic and TOPC Nuclear Medicine Clinic immediately should the inability arise to provide Radiopharmaceutical doses. The inability to provide radiopharmaceuticals that will delay patient care gives the Ann Arbor VAMC and TOPC authority to purchase required radiopharmaceuticals from a different vendor. 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 Ann Arbor VAMC and TOPC. SCHEDULE OF SUPPLIES AND SERVICES The Department of Veterans Affairs Ann Arbor Health Care System for the Ann Arbor VA Medical Center and the Toledo Outpatient Clinic, Nuclear Medicine Service requires the contractor/licensee to provide radiopharmaceuticals, and any needed quality check/QC/etc. sources to be used with Radioassay, Radiopharmacy, Gamma Camera/SPECT, SPECT/CT, and PET/CT imaging systems within Ann Arbor VAMC and TOPC. PRODUCT NAME UNIT Volumed Used (Avg/yr based on volume last 5yrs, Ann Arbor + Toledo) Tc99m-Sestimbi UD UNIT DOSE (EACH) 2,800 Tc99m-Pentetate (DTPA) UNIT DOSE (EACH) 43 Pentetate (DTPA) Kit Vial 4 In111 Pentreotide UNIT DOSE (EACH) 1 F-18 FDG UNIT DOSE (EACH) 1,350 Ga68 Dotatate or Cu64 Dotatate UNIT DOSE (EACH) 24 I123 Andreview (MIBG) UNIT DOSE (EACH) 1 I-131 mCi 450 mCi I-131 Diagnotic Cap UNIT DOSE (EACH) 20 Tc99m- Albumin Aggregated (MAA) UNIT DOSE (EACH) 51 Albumin Aggregated (MAA) Kit Vial 4 Tc99m- Mertiatide (MAG3) UNIT DOSE (EACH) 32 Tc99m-Medronate (MDP) UNIT DOSE (EACH) 350 Medronate (MDP) Kit Vial 6 Tc99m-Mebrofenin UNIT DOSE (EACH) 24 Mebrofenin Kit Vial 6 Tc99m- Pyrophosphate (PYP) UNIT DOSE (EACH) 15 Pyprophosphate (PYP) Kit Vial 2 Tc99m- Sulfur Colloid UNIT DOSE (EACH) 78 Tc99m- Filtered Sulfur Colloid UNIT DOSE (EACH) 70 Sodium Pertechnetate (Tc99m) mCi 30,000 mCi Tl-201 Thallous Chloride mCi 170 mCi Ultratag RBC Kit Vial 65 WBC BLOOD KIT kit 1 In111 White Blood Cells (WBC) UNIT DOSE (EACH) 1 Tc99m Exametazime (Ceretec) WBC UNIT DOSE (EACH) 1 Tc99m DTPA Renal UNIT DOSE (EACH) 1 Tc99m Bicisate UNIT DOSE (EACH) 1 I-123 200uCi Cap Capsule 1 Acetone Bottle 2 20% NaCl 30ml Bottle 2 QC STRIP RED 150-001 50strips/pack 1 QC STRIP BLACK 150-005 50strips/pack 1 QC STRIP ORANGE 150-122 50strips/pack 1 QC STRIP Light Blue 50strips/pack 1 * Vendors are encouraged to list any additional line items they can provide, including new to market products and radiotracers that may provide a contingency source for other Nuclear Medicine Service modalities.