Loren Data's SAM Daily™

SAMDAILY.US - ISSUE OF JUNE 07, 2024 SAM #8228
SOURCES SOUGHT

65 -- VA Loma Linda Radiopharmaceuticals

Notice Date

6/5/2024 12:00:27 PM
 

Notice Type

Sources Sought
 

NAICS

325412 — Pharmaceutical Preparation Manufacturing
 

Contracting Office

262-NETWORK CONTRACT OFFICE 22 (36C262) Gilbert AZ 85297 USA
 

ZIP Code

85297
 

Solicitation Number

36C26224Q1288
 

Response Due

6/14/2024 10:00:00 AM
 

Archive Date

07/14/2024
 

Point of Contact

Hestia Sim, Contract Specialist
 

E-Mail Address

Hestia.Sim@va.gov
(Hestia.Sim@va.gov)
 

Awardee

null
 

Description

This is a SOURCES SOUGHT ANNOUNCEMENT ONLY. It is neither a solicitation announcement nor a request for proposals or quotes and does not obligate the Government to award a contract. Responses to this sources sought notice must be in writing. The purpose of this sources sought announcement is for market research to make appropriate acquisition decisions and to gain knowledge of potential businesses interested and capable of providing the supplies described below. STATEMENT OF WORK (SOW) GENERAL The intent of this Request is to enter into a Firm Fixed-Priced Contract to provide Radiopharmaceutical Supplies to the participating Veterans Affairs Healthcare System facilities specified herein. All Radiopharmaceutical Supplies shall be provided in accordance with the terms and conditions, and provisions of this solicitation for the base year period of October 1, 2025, thru September 30, 2026, with the Government s option to extend the contract for four (4) additional one-year periods. Shipping must be included in the cost. DELIVERY LOCATION, NORMAL WORK HOURS AND INSTRUCTIONS: Delivery shall be made next business days. 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. Routine Order: Routine orders require delivery the next business day, unless specified elsewhere in this contract. Emergency Order: An emergency delivery requires same day delivery and with the time specified during the placement of order. Place of Performance: Delivery Location VA LOMA LINDA HEALTHCARE SYSTEM (VALLHCS) Nuclear Medicine Section, Imaging Service Main hospital, 4th Floor, Room 4E15, Extension 2669, 11201 Benton Street, Loma Linda CA 92357 Normal Work Hours 8:00am to 4:00pm, Monday through Friday Period of Performance: Base: 10/1/2024 - 9/30/2025 Option Year 1: 10/1/2025 - 9/30/2026 Option Year 2: 10/1/2026 - 9/30/2027 Option Year 3: 10/1/2027 - 9/30/2028 Option Year 4: 10/1/2028 - 9/30/2029 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. 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 program office manager. 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. NATIONAL HOLIDAYS OBSERVED BY THE GOVERNMENT: 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. CONTRACTOR DELIVERY PERSONNEL: All contractor personnel are required to wear clothing bearing the name of the Contractor and wear a badge that has the Contractor name. Contractor personnel must have a picture I.D. and must be able to speak English. PARKING AND SPEED LIMIT: Park only in areas designated by the Point of Contact (POC) or otherwise directed by Police and Security Service personnel. The Contractor shall display on each of its vehicles the company name in a size that is clearly visible. Upon receipt of award, the Contractor shall submit a list of employees and vehicles to the POC of each facility. The Contractor shall conform to the speed limit set at each Government facility. Should Contractor personnel receive a citation for parking, speeding or other infraction from VA Security, the offenses will be handled in Federal Court as they are Federal offenses. 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. PERSONNEL POLICY: The parties agree that the contract personnel working this contract shall not be considered VA employees for any purpose and shall be considered employees of the contractor. SMOKING POLICY: Smoking is prohibited at our facility. ITEM DESCRIPTIONS, QUANTITIES, AND SALIENT CHARACTERISTICS: VA Product Description Quantity 18-FDG 12 mCi per dose 240 F18 NAF 10 mCi 240 F-18 FDG US (30mCi max)- Linearity- Source 4 F-18 FDG Dispensing Fee 240 Sodium Iodine I-123 200 uci per dose 35 Sodium Iodide I-131 First 6 mCi (Diagnostic) 10 Sodium Iodide I-131 Therapy Caps each additional mCi 30 In-111 Pentetreotide UD 25 Tc99m-Pyrophsophate 50 Sincalide Vile 80 Tc99m SC Filtered 1 mCi dose 17 Tc-99 Macro Aggregated Albumin UD 100 Tc99m MAA 1-6 mCi dose 100 Tc-99m Mebrofenin UD 100 Tc-99m Medronate UD 150 Tc-99m Meritatide UD 600 Tc- 99m NaTc04 MD 30 Tc-99m NaTc04 UD mCi 25 Tc-99 Pentetate UD 100 Tc-Sestamibi 30 mCi dose 15 Tc-Sestamibi 10 mCi dose 15 Tc99m Sulfur Colloid 1-7 mCi dose 135 Tc-99m Tetrofosmin UD 2400 Tc-99m exematzine WBC's 40 Tc-99m non- HEU Examatazime UD 5 Tc-99m Non-HEU Filtered Sulfer Colloid U 135 Tc-99m Non =-HEU Macro Aggregated Albumin 100 Tc-99m Non- HEU Mebrofenin UD 150 Tc-99m Non_HEU Medronate UD 600 Tc-99m Non -HEU Mertiatide UD 65 Tc-99m Non-HEU NaTc04 MD 30 Tc-99m Non-HEU NaTc04 UD mCi 25 Tc-99m Non-HEU Pentetate UD 100 Tc-99m Non-HEU Pyrophosphate UD 15 Tc-99m Non-HEU Sestamnib UD 60 Tc-99m Non-HEU Sulfer Colloid UD 135 Tc-99m Non-HEU Tetrofsmin UD 2,500 Tc-99m Non- HEU Autologous WBC Suspension 25 Nephroscan 10 Tc-99m Non HEU Mertiatide 50 Lymphoseek Study Dose 86 Stat 300 Balloons for H Pylori breath test 4 sets Halyard PY Test Breath Collection fluid 4 Liquid Scintillation 4 sets C-14 Urea Capsule 150 F-18 Sodium Flouride 10 Gallium 67 5 mci 4 Thallium-201 1 mCi 10 Numerous radioactive radiopharmaceutical injectable doses and radiopharmaceutical supplies. Radioactive agent may be Injection, USP. Able to assay the dose in a suitable dose calibrator prior to administration. Is a sterile dose for intravenous injection. Interested contractor must be able to provide ALL requested radiopharmaceuticals above. No partial quote shall be accepted. Items being offered must be in compliance with the Buy American Act. If you are interested and are capable of providing the required supplies, please provide the following information. (1) Company Name, Address, Point of Contact (2) Size status and representations of your business, such as but not limited to: Service Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB), HUBZone, Woman Owned Small Business (WOSB), Large Business, etc. (3) Is your company considered small under the NAICS code 325412 Pharmaceutical Preparation and Manufacturing? (4) Does your company have an FSS contract with GSA or the NAC or are you a contract holder with any other federal contract? If so, please provide the contract type and number. (5) If you are an FSS GSA/NAC or other federal contract holder, are the referenced items/solutions available on your schedule/contract? (6) Please provide general pricing and product lead time for your products/solutions for market research purposes. (7) Please submit a capability statement that addresses qualifications and verifies ability to perform work described above. The Government is not obligated to nor will it pay for or reimburse any costs associated with responding to this sources sought announcement. This notice shall not be construed as a commitment by the Government to issue a solicitation or ultimately award a contract, nor does it restrict the Government to a particular acquisition approach. The Government will in no way be bound to this information if any solicitation is issued. The VA is mandated by Public Law 109-461 to consider a total set-aside for Service Disabled Veteran Owned Small Businesses. However, if there are insufficient Service Disabled Veteran Owned Small Business responses, an alternate set-aside or full and open competition may be determined. No sub-contracting opportunity is anticipated. The North American Classification System (NAICS) code for this acquisition is 325412 (1 employees). Responses to this notice shall be submitted via email to Hestia.Sim@va.gov. Telephone responses will not be accepted. Responses must be received no later than 6/14/2024 10:00 AM Pacific Local Time. After review of the responses to this sources sought announcement, a solicitation may be published on the beta.sam.gov or GSA eBuy websites. Responses to this sources sought announcement will not be considered adequate responses to the solicitation. All interested offerors must respond to the solicitation in addition to responding to this sources sought announcement. Prospective bidders must be authorized re-sellers in order to participate in the solicitation process. Notice to potential offerors: All offerors who provide goods or services to the United States Federal Government must be registered in the System for Award Management (SAM) at www.sam.gov. Additionally, all Service Disabled Veteran Owned Small Businesses or Veteran Owned Small Businesses must be registered with U.S. Small Business Administration (SBA) located at http://veterans.certify.sba.gov.
 

Web Link

SAM.gov Permalink
(https://sam.gov/opp/b444272dd5fb421ea494019b60735123/view)
 

Place of Performance

Address: Department of Veterans Affairs VA Loma Linda Healthcare Sytem Nuclear Medicine Service 11201 Benton Street, Loma Linda 92357, USA

Zip Code: 92357

Country: USA
 

Record

SN07087796-F 20240607/240605230120 (samdaily.us)
 

Source

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

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